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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
5
] | 51 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | Phase 4 commitment pharmacokinetic study to determine systemic exposure to adapalene. | Multi-center, double-blind, randomized, parallel group study enrolling male or female subjects with acne vulgaris.
Screening will take place within 14 days prior to Baseline. At the Baseline visit, and at each study day up to Day 30, a trained nurse or technician will apply 2 grams of study medication (either Differin... | Acne Vulgaris | Acne vulgaris Differin Adapalene | null | 2 | arm 1: Gel, 0.3%, 2g, once daily for 30 days arm 2: Gel, 0.1%, 2g, once daily for 30 days | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Gel, 0.3%, 2g, once daily for 30 days intervention 2: Gel, 0.1%, 2g, once daily for 30 days | intervention 1: Adapalene intervention 2: Adapalene | 2 | Austin | Texas | United States | -97.74306 | 30.26715
College Station | Texas | United States | -96.33441 | 30.62798 | 0 | NCT00660985 |
[
3
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of multiple ascending doses of AZD0328 in patients with schizophrenia | null | Schizophrenia | null | 4 | arm 1: AZD0328 low dose arm 2: AZD0328 Optimal dose arm 3: AZD0328 High dose arm 4: Placebo Comparator | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: AZD0328 intervention 2: Placebo | 2 | Garden Grove | California | United States | -117.94145 | 33.77391
Glendale | California | United States | -118.25508 | 34.14251 | 0 | NCT00669903 | |
[
2,
3
] | 104 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 2DOUBLE | false | 0ALL | false | Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate. And to compare efficacy on the dose groups. | null | Rheumatoid Arthritis | Rheumatoid Arthritis | null | 12 | arm 1: AIN457A 0.3 mg/kg was administered intravenously as a single dose. arm 2: AIN457A 1.0 mg/kg was administered intravenously as a single dose. arm 3: AIN457A 3.0 mg/kg was administered intravenously as a single dose. arm 4: AIN457A 10.0 mg/kg was administered intravenously as a single dose. arm 5: Placebo to AIN45... | [
0,
0,
0,
0,
2,
0,
0,
0,
2,
0,
0,
2
] | 2 | [
2,
0
] | intervention 1: AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A. intervention 2: Placebo to AIN457 | intervention 1: AIN457 intervention 2: Placebo | 24 | Anniston | Alabama | United States | -85.83163 | 33.65983
Tucson | Arizona | United States | -110.92648 | 32.22174
Largo | Florida | United States | -82.78842 | 27.90979
Ocala | Florida | United States | -82.14009 | 29.1872
Palm Harbor | Florida | United States | -82.76371 | 28.07807
Port Orange | Florida | United Stat... | 0 | NCT00669942 |
[
3
] | 90 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients who are currently on metformin monotherapy. | null | Type 2 Diabetes Mellitus | GLP-1, incretin, type 2 diabetes | null | 3 | arm 1: Twice-a-week dose of 1.5 mg CJC-1134-PC arm 2: Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo arm 3: Twice-a-week placebo for CJC-1134-PC | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: twice-a-week intervention 2: twice-a-week | intervention 1: 1.5 mg or 2.0 mg CJC-1134-PC intervention 2: Placebo | 1 | Montreal | Quebec | Canada | -73.58781 | 45.50884 | 0 | NCT00674466 |
[
5
] | 7 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month | null | Schizophrenia Schizoaffective Disorder Schizophreniform Disorder | Schizophrenia Integrated Care Quetiapine | null | 2 | arm 1: Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion arm 2: Oral administration as 200 mg and 300 mg tablets allowi... | [
0,
0
] | 2 | [
0,
10
] | intervention 1: 400-800 mg, oral, bid intervention 2: Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime ... | intervention 1: Quetiapine XR intervention 2: Integrated Care Program (ICP) | 8 | München | Bavaria | Germany | 13.46314 | 48.69668
Oranienburg | Brandenburg | Germany | 13.24197 | 52.75577
Hamburg | City state of Hamburg | Germany | 9.99302 | 53.55073
Lüneburg | Lower Saxony | Germany | 10.41409 | 53.2509
Oldenburg | Lower Saxony | Germany | 8.21467 | 53.14118
Chemnitz | Saxony | Germany | 12.92922... | 0 | NCT00681629 |
[
5
] | 7 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | Subjects will be given 3 infusions of infliximab according to the label at week 0, 2, and 6. Subjects will be followed for a maximum of 18 weeks or until relapse. This study will assess the ability of the Power Doppler Ultrasonography (PDUS) to be a reliable marker of enthesitis response and relapse in subjects treated... | null | Spondylitis, Ankylosing SpA | null | 1 | arm 1: Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6. | [
0
] | 2 | [
3,
0
] | intervention 1: PDUS scored for each enthesitis every 2 weeks for 24 weeks. intervention 2: * 5 mg/kg
* IV
* Frequency : weeks 0,2,6 | intervention 1: PDUS intervention 2: Infliximab | 0 | null | 0 | NCT00686894 | |
[
3
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary objective of this study is to assess the efficacy and safety of an extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment of fibromyalgia.
The objective of the open-label phase is to assess the safety profile and effect of Pramipexole (PPX) extended-release (ER) in fi... | null | Fibromyalgia | null | 2 | arm 1: 0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening arm 2: Placebo tablets, once daily in the evening | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: pramipexole ER intervention 2: placebo | 42 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Arcadia | California | United States | -118.03534 | 34.13973
Los Angeles | Californi... | 0 | NCT00689052 | |
[
4
] | 10 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study is intended to provide evidence that zonisamide is safe and effective in the treatment of myoclonic seizures. The total planned trial duration will be 6.5 months. After that, subjects who have completed the study will be eligible to enroll in an open-label extension study until zonisamide is marketed for thi... | null | Epilepsy | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 50-400 mg capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg (or 350... | intervention 1: Zonisamide intervention 2: Placebo | 72 | Chatswood | New South Wales | Australia | 151.18333 | -33.8
Randwick | New South Wales | Australia | 151.24895 | -33.91439
Heidelburg | Victoria | Australia | N/A | N/A
Melbourne | Victoria | Australia | 144.96332 | -37.814
Split | HR | Croatia | 16.43915 | 43.50891
Zagreb | HR | Croatia | 15.97798 | 45.81444
Zagreb | ... | 0 | NCT00693017 | |
[
4
] | 126 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery | null | Cataract | Cataract extraction with intraocular lens implantation | null | 2 | arm 1: Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily arm 2: Placebo, Dosed 1 Drop Daily | [
0,
2
] | 2 | [
0,
0
] | intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution | intervention 1: bromfenac ophthalmic solution intervention 2: placebo | 1 | Irvine | California | United States | -117.82311 | 33.66946 | 0 | NCT00703781 |
[
3
] | 121 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control. | null | Diabetes Mellitus, Type 2 | null | 3 | arm 1: Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin. arm 2: Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin. arm 3: Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin. | [
2,
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: once daily for 28 days intervention 2: once daily for 28 days intervention 3: 100 mg once daily for 28 days intervention 4: once daily for 28 days intervention 5: once daily for 28 days intervention 6: 5mg once daily for 28 days | intervention 1: Placebo (linagliptin) intervention 2: Placebo (linagliptin) intervention 3: Sitagliptin intervention 4: Placebo (sitagliptin) intervention 5: Placebo (sitagliptin) intervention 6: Linagliptin | 3 | Berlin | N/A | Germany | 13.41053 | 52.52437
Mainz | N/A | Germany | 8.2791 | 49.98419
Neuss | N/A | Germany | 6.68504 | 51.19807 | 0 | NCT00716092 | |
[
5
] | 30 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment. | null | Human Immunodeficiency Virus (HIV) Infection | maraviroc, pharmacokinetics, renal impairment | null | 5 | arm 1: Subjects with Normal Renal Function (Creatinine Clearance \> 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir arm 2: Subjects with Mild Renal Impairment (Creatinine Clearance \>50 and ≤80 mL/min) arm 3: Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤5... | [
0,
0,
0,
0,
0
] | 13 | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Maraviroc 300 mg (150 mg x 2 tablets) x single dose intervention 2: Maraviroc 150 mg tablet twice daily x 7 days intervention 3: Ritonavir 100 mg capsule twice daily x 7 days intervention 4: Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days intervention 5: Maraviroc 150 mg tablet once daily x... | intervention 1: Maraviroc intervention 2: Maraviroc intervention 3: Ritonavir intervention 4: Saquinavir intervention 5: Maraviroc intervention 6: Ritonavir intervention 7: Saquinavir intervention 8: Maraviroc intervention 9: Ritonavir intervention 10: Saquinavir intervention 11: Maraviroc intervention 12: Maraviroc in... | 2 | Berlin | N/A | Germany | 13.41053 | 52.52437
München | N/A | Germany | 13.31243 | 51.60698 | 0 | NCT00717067 |
[
3
] | 92 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | * Multi-Center
* Randomized
* Open-Label Study of single agent IMO-2055
* Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC) | This is a study of 2 dose levels (0.16 or 0.64 mg/kg) of IMO-2055 administered by weekly subcutaneous (SC) injections in two patient populations, treatment naïve or previously treated patients. Each dose group (treatment naive or previously treated) will be randomized to receive one of the 2 doses being studied. | Renal Cell Carcinoma | renal cell renal carcinoma metastatic recurrent treatment naive | null | 4 | arm 1: Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg arm 2: Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg arm 3: P... | [
1,
1,
1,
1
] | 1 | [
0
] | intervention 1: immunostimulatory oligonucleotide | intervention 1: IMO-2055 | 1 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 | 0 | NCT00729053 |
[
4
] | 351 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis. | null | Allergic Rhinitis | null | 2 | arm 1: Mometasone furoate nasal spray 200 mcg QD (once per day) arm 2: Matching placebo nasal spray | [
0,
2
] | 2 | [
0,
0
] | intervention 1: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days intervention 2: Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days | intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Matching placebo nasal spray | 0 | null | 0 | NCT00732381 | |
[
4
] | 776 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) are more effective than placebo or either medication alone (azelastine or fluticasone) | This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twi... | Seasonal Allergic Rhinitis | null | 4 | arm 1: nasal spray arm 2: nasal spray arm 3: nasal spray arm 4: nasal spray | [
0,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID intervention 2: azelastine Hcl 548 mcg one spray per nostril BID intervention 3: fluticasone propionate 200 mcg one spray per nostril BID intervention 4: placebo one spray per nostril BID | intervention 1: azelastine HCl/fluticasone propionate intervention 2: azelastine Hcl intervention 3: fluticasone propionate intervention 4: placebo | 39 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Encinitas | California | United States | -117.29198 | 33.03699
Fountain Valley | California | United States | -117.95367 | 33.70918
Fresno | California | United States | -119.77237 | 36.74773
Long Beach | California | United States | -118.18923 | 33.76696
Los... | 0 | NCT00740792 | |
[
5
] | 211 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain. | null | Pain | Dental pain analgesia | null | 3 | arm 1: None arm 2: None arm 3: None | [
2,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 2 placebo gels capsules delivered as a single dose. intervention 2: 2 marketed ibuprofen gels intervention 3: 2 marketed ibuprofen gels | intervention 1: placebo intervention 2: ibuprofen Formulation 1 intervention 3: ibuprofen Formulation 2 | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00740857 |
[
5
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This purpose of this study is to understand the differences between people who have a good response to deferasirox (exjade) compared to people who have a poor response to this medication when used for transfusion-dependent iron overload.
The hypothesis is that patients with poor responses have physiologic barriers to ... | The purpose of this trial is to examine three potential mechanisms of inadequate response to Exjade® in patients with transfusion dependent iron overload including patients with thalassemia syndromes, sickle cell disease and bone marrow failure.
Hypothesis: Patients have physiologic barriers to adequately respond to d... | Transfusion-dependent Hemachromatosis Thalassemia Major Sickle Cell Disease | Thalassemia Iron Chelation | null | 1 | arm 1: All patients received the same interventions of deferoxamine challenge, deferasirox dose with pharmacokinetic monitoring and HIDA scan. Then we compared responses between patients who were known to be slow responders to deferasirox and those who were known to be rapid responders (chelated well). | [
0
] | 3 | [
0,
0,
4
] | intervention 1: After a 3-day washout period from all chelation, all patients have a 12 hour infusion of 50mg/kg of deferoxamine with urine collection and pre and post blood sampling to assess iron and Total Iron Binding Capacity (TIBC) by atomic absorption. intervention 2: After a 3-day washout period from all chelati... | intervention 1: Deferoxamine intervention 2: Deferasirox intervention 3: HIDA | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00749515 |
[
4
] | 497 | NON_RANDOMIZED | SINGLE_GROUP | null | 0NONE | false | 0ALL | false | The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment. | Issues on adverse event data are addressed in the Adverse Event section.
The following acronyms and abbreviations were used in the results section.
\- General Educational Development (GED) | Pain | Non-prescription | null | 1 | arm 1: subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever | [
0
] | 1 | [
0
] | intervention 1: Consumer use of Extended Release Naproxen Sodium | intervention 1: Naproxen Sodium ER (BAYH6689) | 24 | Anaheim | California | United States | -117.9145 | 33.83529
Oceanside | California | United States | -117.37948 | 33.19587
San Dimas | California | United States | -117.80673 | 34.10668
Overland Park | Kansas | United States | -94.67079 | 38.98223
Anoka | Minnesota | United States | -93.38718 | 45.19774
Blaine | Minnes... | 0 | NCT00751400 |
[
4
] | 386 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy. | null | Colon Cancer | colonoscopy screening | null | 2 | arm 1: multi-dose preparation for oral administration prior to colonoscopy arm 2: multi-dose preparation for oral administration prior to colonoscopy | [
0,
1
] | 2 | [
0,
0
] | intervention 1: multi-dose preparation for oral administration prior to colonoscopy intervention 2: multi-dose preparation for oral administration prior to colonoscopy | intervention 1: BLI850 intervention 2: polyethylene glycol 3350 based bowel preparation | 12 | Anaheim | California | United States | -117.9145 | 33.83529
Orange | California | United States | -117.85311 | 33.78779
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Jackson | Mississippi | United States | -90.18481 | 32.29876
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
Portland | Oregon | U... | 0 | NCT00756548 |
[
4
] | 394 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy. | null | Colon Cancer | Colonoscopy screening | null | 2 | arm 1: multi-dose preparation for oral administration prior to colonoscopy arm 2: multi-dose preparation for oral administration prior to colonoscopy | [
0,
1
] | 2 | [
0,
0
] | intervention 1: multi-dose preparation for oral administration prior to colonoscopy intervention 2: multi-dose preparation for oral administration prior to colonoscopy | intervention 1: BLI850 intervention 2: polyethylene glycol 3350 based bowel preparation | 12 | Mobile | Alabama | United States | -88.04305 | 30.69436
Jupiter | Florida | United States | -80.09421 | 26.93422
Miami | Florida | United States | -80.19366 | 25.77427
New Smyrna Beach | Florida | United States | -80.927 | 29.02582
Roswell | Georgia | United States | -84.36159 | 34.02316
Monroe | Louisiana | United Sta... | 0 | NCT00756977 |
[
3,
4
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity in patients with symptomatic ischemic heart failure. | Recent studies have showed the importance of proinflammatory mediators in the heart failure. However, there is a lack of benefit of therapies that tried to neutralize these mediators.
Methotrexate has adenosine-mediated anti-inflammatory effects in rheumatoid arthritis and psoriasis. Methotrexate limits infarct size v... | Heart Failure Myocardial Ischemia | Heart Failure Myocardial Ischemia Methotrexate Inflammation Anti-Inflammatory Agents Inflammation Mediators | null | 2 | arm 1: Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks. arm 2: Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edit... | intervention 1: Methotrexate intervention 2: Placebo | 1 | Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283 | 0 | NCT00759811 |
[
4
] | 461 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin. | In Japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary artery by-pass surgery and percutaneous transluminal coronary angioplasty in patients. While low-dose aspirin is effective i... | Stomach Ulcer Duodenal Ulcer | Curling Ulcer Gastric Ulcer Aspirin Acetylsalicylic Acid Drug Therapy | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months. intervention 2: Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months. | intervention 1: Lansoprazole intervention 2: Gefarnate | 65 | Matsudo-shi | Chiba | Japan | N/A | N/A
Yotsukaido-shi | Chiba | Japan | N/A | N/A
Imabari | Ehime | Japan | 133.00023 | 34.07001
Matsuyama | Ehime | Japan | 132.76574 | 33.83916
Fukui-shi | Fukui | Japan | 136.22257 | 36.06443
Fukuoka | Fukuoka | Japan | 130.41667 | 33.6
Onga-gun | Fukuoka | Japan | N/A | N/A
Gifu | G... | 0 | NCT00762359 |
[
3
] | 411 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | true | 0ALL | false | The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a virus that causes many common colds. | Rhinovirus infections are the most frequent cause up to 80% of cold illnesses during the fall rhinovirus season. While viral upper respiratory infections are generally mild and self-limited, they are associated with an enormous economic burden both in lost productivity and in expenditures for treatment. Rhinovirus infe... | Common Cold | cold, common rhinovirus | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: * topical product
* apply 2 pumps
* apply at least every 4 hours or after hand washing intervention 2: * topical
* apply 2 pumps
* apply at least every 4 hours or after hand washing | intervention 1: 3804-250A intervention 2: 3804-291 | 2 | Paramus | New Jersey | United States | -74.07542 | 40.94454
Charlottesville | Virginia | United States | -78.47668 | 38.02931 | 0 | NCT00762476 |
[
5
] | 102 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | true | 0ALL | false | To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis. | null | Allergic Rhinitis | rhinitis | null | 1 | arm 1: Olopatadine 0.6% / Azelastine 137 mcg | [
0
] | 1 | [
0
] | intervention 1: single dose; 2 sprays per nostril | intervention 1: Olopatadine 0.6% / Azelastine 137 mcg | 1 | Fort Worth | Texas | United States | -97.32085 | 32.72541 | 0 | NCT00772304 |
[
2
] | 22 | RANDOMIZED | CROSSOVER | 2DIAGNOSTIC | 2DOUBLE | false | 0ALL | false | This study will evaluate a walking model of osteoarthritis for use in testing of new therapeutic agents. The primary hypothesis is that participants treated with Naproxen or Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during self-paced walks on Day 3 of treatment. | null | Osteoarthritis | null | 6 | arm 1: Participants were treated with Placebo for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 2: Participants were treated with Naproxen for 3 days in Treatment Period 1, Ultracet for... | [
0,
0,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Naproxen tablets 500 mg twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Twice daily on Day 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. intervention 2: Placebo capsules twice daily on Day 1, a first dose at t... | intervention 1: Naproxen intervention 2: Placebo intervention 3: Ultracet | 0 | null | 0 | NCT00772967 | |
[
0
] | 26 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigat... | null | Obesity | pre-diabetes isotopes insulin secretion insulin action GLP-1 simple obesity impaired fasting glucose | null | 2 | arm 1: Treatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate) arm 2: Treatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate) | [
0,
0
] | 1 | [
0
] | intervention 1: Januvia 100 mg po qd x 28 days for all subjects after baseline measures made | intervention 1: Sitagliptin Phosphate | 1 | Aurora | Colorado | United States | -104.83192 | 39.72943 | 0 | NCT00795275 |
[
0
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Current therapeutic options for ureteral stones include active intervention as well as conservative "watch and wait" approaches. Endoscopic treatment of ureteral stones has a high success rate and reliably results in immediate stone removal However, surgical as well as anaesthetic risks are not negligible and serious c... | null | Ureteral Calculi | Adrenergic alpha antagonists drug therapy tamsulosin ureter | null | 2 | arm 1: Tamsulosin treatment arm 2: Placebo treatment | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 0.4 mg Tamsulosin once daily for 21 days intervention 2: One placebo pill per day for 21 days or until stone expulsion | intervention 1: Tamsulosin intervention 2: Placebo | 1 | Zurich | N/A | Switzerland | 8.55 | 47.36667 | 0 | NCT00831701 |
[
2
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 1FEMALE | true | The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). | null | Partial Epilepsy | Partial Epilepsy Eslicarbazepine acetate Combined oral contraceptive Pharmacokinetics Tolerability | null | 2 | arm 1: A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®). arm 2: 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharma... | [
5,
0
] | 2 | [
0,
0
] | intervention 1: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period intervention 2: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel) | intervention 1: eslicarbazepine acetate and Microginon® intervention 2: Microginon® | 1 | Porto | N/A | Portugal | -8.61099 | 41.14961 | 0 | NCT00898560 |
[
0
] | 33 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 0NONE | true | 1FEMALE | false | The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have low... | null | Oral Contraceptive | Oral Contraceptives Breast Tissue | null | 2 | arm 1: Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. arm 2: Ovcon Fe® is an oral contraceptive that contains less progestin. | [
1,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Oral Contraceptive: Ortho-Novum® 1/35 intervention 2: Oral Contraceptive: Ovcon Fe® | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00972439 |
[
3
] | 557 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy. | null | Painful Diabetic Neuropathy | pain diabetes neuropathy | null | 6 | arm 1: ESL 400 mg twice daily (BID) arm 2: ESL 800 mg once-daily (QD) arm 3: Eslicarbazepine 600 mg twice daily arm 4: Eslicarbazepine acetate 1200 mg once daily arm 5: Eslicarbazepine acetate 800 mg twice daily arm 6: Placebo | [
0,
0,
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. intervention 2: oral route | intervention 1: Eslicarbazepine acetate intervention 2: Placebo | 0 | null | 0 | NCT00980746 |
[
4
] | 288 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee and who previously did not receive any strong opioids.The clinical trial tests the effect of... | In this clinical trial subjects are enrolled, who are suffering from pain due to osteoarthritis of the hip or the knee that is not sufficiently controlled with either a non steroidal anti-inflammatory drug (NSAID) or paracetamol or a weak opioid. This clinical trial tests the pain relieving effectiveness of OROS hydrom... | Pain Osteoarthritis, Hip Osteoarthritis, Knee | Osteoarthritis Strong pain killer Strong opioid Low starting dose Fewer side effects Physical functioning Pain control Quality of life Sleep quality | null | 2 | arm 1: OROS hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks arm 2: Placebo placebo tablet once daily for 16 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 4 to 32 mg taken orally once daily for 16 weeks intervention 2: placebo tablet once daily for 16 weeks | intervention 1: OROS hydromorphone HCl intervention 2: Placebo | 12 | Klatovy | N/A | Czechia | 13.29505 | 49.39552
Olomouc | N/A | Czechia | 17.25175 | 49.59552
Pelhøimov | N/A | Czechia | N/A | N/A
Prague | N/A | Czechia | 14.42076 | 50.08804
Roudnice nad Labem | N/A | Czechia | 14.26175 | 50.42528
Bucharest | N/A | Romania | 26.10626 | 44.43225
Cluj-Napoca | N/A | Romania | 23.6 | 46.... | 0 | NCT00980798 |
[
5
] | 18 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.
C-reactive Protein (CRP) is... | null | COPD | null | 2 | arm 1: FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. After a washout period of 2 weeks, they then received FP matched placebo pMDI one puff twice daily for two weeks then FP four pu... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Fluticasone propionate intervention 2: Placebo | 0 | null | 0 | NCT00995475 | |
[
5
] | 18 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | true | 1FEMALE | true | In the United States, the majority of first-trimester surgical abortions are performed in outpatient clinics that utilize a wide variety of oral and intravenous regimens for pain control. The specific aim of this study is to evaluate the equivalency of intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg)... | Approximately 50% of pregnancies in the United States are unintended and about 50% of these end in an induced abortion. In 2000, approximately 1.31 million abortions were performed in the United States, approximately 88% of which were less than 12 weeks gestational age. There has been a movement toward performing elect... | Undesired Intrauterine Pregnancy First Trimester Pregnancy | abortion uterine aspiration pain control | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 1 | [
0
] | intervention 1: Intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg) | intervention 1: Intravenous moderate sedation versus oral medication | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT01011634 |
[
2
] | 58 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted state. | Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain. | Healthy | Healthy subjects Opioid Healthy volunteers | null | 2 | arm 1: Reformulated OXY 80 mg (Totowa) x 1 dose arm 2: Reformulated OXY 80 mg (Wilson) x 1 dose | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Reformulated OXY 80-mg tablet (Totowa) x 1 dose taken without food. intervention 2: Reformulated OXY 80-mg tablet (Wilson) x 1 dose taken without food. | intervention 1: Reformulated OXY (Totowa) (oxycodone HCl) intervention 2: Reformulated OXY (Wilson) (oxycodone HCl) | 1 | Honolulu | Hawaii | United States | -157.85833 | 21.30694 | 0 | NCT01101321 |
[
0
] | 84 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | false | 0ALL | false | The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab. | The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood f... | Tobacco Dependence | Smoking Cessation Nicotine | null | 3 | arm 1: An experimental 2 mg nicotine product coded "STD" arm 2: An experimental 2 mg nicotine product coded "STE" arm 3: A comparative 2 mg marketed nicotine product called Nicorette Microtab | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 2 mg Single-dose of experimental nicotine product coded "STD" intervention 2: 2 mg Single-dose of experimental nicotine product coded "STE" intervention 3: A comparative 2 mg Single-dose of marketed tablet | intervention 1: Code STD intervention 2: Code STE intervention 3: Nicorette Microtab | 1 | Lund | N/A | Sweden | 13.19321 | 55.70584 | 0 | NCT01238640 |
[
5
] | 35 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of Transdermal therapeutic system (TTS) fentanyl patches (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is seen mostly in older persons, in which the j... | This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective study (study following participants forward in time) of TTS-fentanyl matrix form in knee osteoarthritis participants. The study consists o... | Osteoarthritis, Knee | Osteoarthritis, Knee Transdermal therapeutic system (TTS) fentanyl Durogesic | null | 1 | arm 1: Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: TTS-fentanyl | 1 | Bangkok | N/A | Thailand | 100.50144 | 13.75398 | 0 | NCT01742897 |
[
2
] | 16 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 2MALE | false | To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/benserazide 100/25 mg (Prolopa® 100-25) | null | Parkinson's Disease (PD) | Parkinson's disease (PD) Opicapone Bia 9-1067 | null | 4 | arm 1: Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
Every period with concomitant single oral administration of Prolopa® 100-25 arm 2: Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
Every period with concomitan... | [
0,
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: levodopa/benserazide 100/25 mg | intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Prolopa® | 1 | Mount Royal | Quebec | Canada | -73.64918 | 45.51675 | 0 | NCT02169895 |
[
2
] | 47 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to compare the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the fixed dose combination (FDC) of 10 μg BI 1744 CL plus 5 μg tiotropium bromide with the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the single ... | null | Pulmonary Disease, Chronic Obstructive | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: BI 1744 CL intervention 2: BI 1744 CL/Tiotropium FDC intervention 3: Tiotropium | 0 | null | 0 | NCT02231177 | |
[
3
] | 253 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2 mg, and 5 mg taken twice a day) of preladenant wit... | null | Parkinson Disease Movement Disorders Central Nervous System Diseases Neurodegenerative Diseases Brain Diseases | null | 5 | arm 1: Participants received preladenant 1 mg twice daily (BID) during the 12-week treatment period. arm 2: Participants received preladenant 2 mg BID during the 12-week treatment period. arm 3: Participants received preladenant 5 mg BID during the 12-week treatment period. arm 4: Participants received preladenant 10 m... | [
0,
0,
0,
0,
2
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 1 mg BID capsules intervention 2: 2 mg BID capsules intervention 3: 5 mg BID capsules intervention 4: 10 mg BID capsules intervention 5: BID capsules intervention 6: Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitan... | intervention 1: Preladenant intervention 2: Preladenant intervention 3: Preladenant intervention 4: Preladenant intervention 5: Placebo intervention 6: L-dopa intervention 7: Other Parkinson's Disease treatments | 0 | null | 1 | NCT00406029 | |
[
2
] | 50 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The study determined the recommended Phase 2 loading and maintenance doses and dose schedules for administering dalotuzumab using dose-limiting toxicities (DLTs) observed during the entire treatment period (Up to 18 months). The primary hypothesis of the study was that administration of dalotuzumab as an every other we... | The study consisted of 3 parts. In Part 1 the loading dose was escalated while the maintenance dose was kept constant. In Part 2 the loading dose was kept constant while the maintenance dose was escalated. In Part 3 the recommended phase 2 loading and maintenance doses and schedule were administered to an expanded coho... | Advanced Solid Tumors | null | 7 | arm 1: Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by intravenous (IV) infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months. arm 2: Participants recei... | [
0,
0,
0,
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: Administered as an IV infusion over one to two hours | intervention 1: dalotuzumab | 0 | null | 0 | NCT00635778 | |
[
4
] | 435 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibr... | This is a Phase 3, randomized, double blind, placebo-controlled, three-arm, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis. Approximately 400 patients at approximately 70 centers will be randomly assigned (2:2:1) to receive either 2403 milligrams (mg) of pirfenidone, placebo equ... | Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis Lung Pirfenidone InterMune | null | 3 | arm 1: Active arm 1, 2403 mg/day pirfenidone dose group. arm 2: Active arm 2, 1197 mg/day pirfenidone. arm 3: Placebo equivalent. | [
1,
1,
2
] | 2 | [
0,
0
] | intervention 1: 1197 or 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study. intervention 2: Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study. | intervention 1: Pirfenidone intervention 2: Placebo | 1 | Brisbane | California | United States | -122.39997 | 37.68077 | 0 | NCT00287716 |
[
3
] | 156 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study wi... | null | Pulmonary Disease, Chronic Obstructive | Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Pulmonary Disease Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease COPD COAD | null | 3 | arm 1: Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening arm 2: Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening arm 3: Formoterol f... | [
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning intervention 2: Inhaled formoterol fumarate 12 µg twice-daily (BID) intervention 3: Inhaled placebo to formoterol fumarate once-daily in the evening intervention 4: Inhaled formoterol fumarate 12... | intervention 1: Once-daily aclidinium/formoterol intervention 2: Twice-daily formoterol fumarate intervention 3: Placebo to formoterol fumarate intervention 4: Once-daily formoterol fumarate | 40 | Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Fullerton | California | United States | -117.92534 | 33.87029
Lakewood | California | United States | -118.13396 | 33.85363
Rancho Mirage | California | United States | -116.41279 | 33.73974
Redlands | Cal... | 0 | NCT00706914 |
[
4
] | 848 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | null | The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as ... | null | Chemotherapy-Induced Nausea and Vomiting | null | 2 | arm 1: Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg c... | [
5,
5
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period. intervention 2: Ondansetron 8 mg capsule Three day treatment period. intervention 3: dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period. intervention 4: fosaprepitant dimeglumine 115 mg intervention 5: dex... | intervention 1: aprepitant intervention 2: Comparator: ondansetron intervention 3: Comparator: dexamethasone intervention 4: Comparator: fosaprepitant dimeglumine intervention 5: Comparator; Placebo (unspecified) intervention 6: Comparator; Placebo (unspecified) | 0 | null | 0 | NCT00337727 | |
[
3
] | 252 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | This study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period. | null | Endometriosis | null | 3 | arm 1: Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. arm 2: Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. arm 3: Participants r... | [
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Provided as tablets for oral administration intervention 2: Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe. intervention 3: Matching placebo tablets for oral administration intervention 4: Matching placebo for subcutaneous injection in a pre-filled syringe | intervention 1: Elagolix intervention 2: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) intervention 3: Placebo to Elagolix intervention 4: Placebo to DMPA-SC | 0 | null | 0 | NCT00437658 | |
[
3
] | 84 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis. | null | Oesophagitis, Eosinophilic | eosinophilic mepolizumab esophagitis | null | 3 | arm 1: Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8. arm 2: Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8. arm 3: Participants received mepolizumab 10 mg/kg by IV infus... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg), 2.5 mg/kg , or 10 mg/kg by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8. | intervention 1: mepolizumab | 29 | Birmingham | Alabama | United States | -86.80249 | 33.52066
San Diego | California | United States | -117.16472 | 32.71571
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Springfield | Illinois | United States | -89.64371 | 39.80172
Evansville | Indiana | Un... | 0 | NCT00358449 |
[
3
] | 11 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of ob... | null | Head and Neck Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent | intervention 1: Paclitaxel | 9 | Kashiwa-shi | Chiba | Japan | N/A | N/A
Matsuyama | Ehime | Japan | 132.76574 | 33.83916
Kagoshima | Kagoshima-ken | Japan | 130.55 | 31.56667
Yokohama | Kanagawa | Japan | 139.65 | 35.43333
Osaka | Osaka | Japan | 135.50107 | 34.69379
Sunto-gun | Shizuoka | Japan | N/A | N/A
Meguro-ku | Tokyo | Japan | N/A | N/A
Kanag... | 0 | NCT00971867 | |
[
3
] | 159 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | To evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics in patients with osteoarthritic pain of the knee. The most painful knee joint will be identified as the index joint at screening, and this joint will be used for all pain assessments throughout the study. | null | Osteoarthritis, Knee | PF-04136309 CCR2 osteoarthritic pain knee phase 2 placebo multicenter double-blind placebo-controlled | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 125 mg capsules. Dose will be 4 capsules BID for 2 weeks for a total of 500 mg for each dosing interval. intervention 2: Placebo will be matched to PF-04136309. Dose, frequency, and duration same as PF-04136309. | intervention 1: PF-04136309 intervention 2: Placebo | 22 | DeLand | Florida | United States | -81.30312 | 29.02832
South Miami | Florida | United States | -80.29338 | 25.7076
South Miami | Florida | United States | -80.29338 | 25.7076
Overland Park | Kansas | United States | -94.67079 | 38.98223
Overland Park | Kansas | United States | -94.67079 | 38.98223
Madisonville | Kentu... | 0 | NCT00689273 |
[
4
] | 680 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | 3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects | null | Bipolar Disorder | null | 3 | arm 1: None arm 2: None arm 3: None | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Placebo with mood stabilizer (either lithium or divalproex) intervention 2: Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex) intervention 3: Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex) | intervention 1: Placebo intervention 2: Ziprasidone intervention 3: Ziprasidone | 66 | Dothan | Alabama | United States | -85.39049 | 31.22323
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Cerritos | California | United States | -118.06479 | 33.85835
Costa Mesa | California | United States | -117.91867 | 33.64113
Escondido | Cal... | 1 | NCT00312494 | |
[
3
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Eligible patients with metastatic pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine | null | Metastatic Pancreatic Cancer | null | 2 | arm 1: Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. All medications will... | [
0,
1
] | 4 | [
2,
2,
0,
2
] | intervention 1: I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1 intervention 2: 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. intervention 3: 1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. intervention 4: I.V.infusions of 250 mg/m2 (o... | intervention 1: cetuximab intervention 2: bevacizumab intervention 3: gemcitabine intervention 4: cetuximab | 16 | Jonesboro | Arkansas | United States | -90.70428 | 35.8423
San Francisco | California | United States | -122.41942 | 37.77493
Stamford | Connecticut | United States | -73.53873 | 41.05343
Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834
Orlando | Florida | ... | 1 | NCT00326911 | |
[
4
] | 1,306 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone | All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requ... | Diabetes | null | 4 | arm 1: PLUS open-label pioglitazone (as needed as rescue medication) arm 2: PLUS open-label pioglitazone (as needed as rescue medication) arm 3: PLUS open-label pioglitazone (as needed as rescue medication) arm 4: PLUS open-label pioglitazone (as needed as rescue medication) | [
0,
0,
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT) intervention 2: Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT) intervention 3: Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) intervention 4: Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT) interve... | intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Metformin intervention 4: Placebo intervention 5: pioglitazone | 211 | Concord | California | United States | -122.03107 | 37.97798
Encinitas | California | United States | -117.29198 | 33.03699
Orange | California | United States | -117.85311 | 33.78779
Santa Monica | California | United States | -118.49138 | 34.01949
Spring Valley | California | United States | -116.99892 | 32.74477
Sto... | 1 | NCT00327015 | |
[
3
] | 65 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether CPX-1 is effective in patients with advanced colorectal cancer who have already received chemotherapy that included the drug oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90 minutes every two weeks. | CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine. The two drugs are present inside the liposome in a fixed 1:1 molar ratio. CPX-1 was developed as a means of delivering and preserving a fixed 1:1 molar ratio of the two drugs. This rati... | Colorectal Neoplasms | Colorectal cancer Colorectal carcinoma Colonic cancer Rectal cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine. | intervention 1: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection | 13 | Greenbrae | California | United States | -122.5247 | 37.94854
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Coral Springs | Florida | United States | -80.2706 | 26.27119
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Savannah | Georgia | United States | -81.09983 | 32.0... | 1 | NCT00361842 |
[
4
] | 429 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of \< 50 copies/mL) over a 48-week treatment period in HIV-positive women ... | This is a multi-center, open-label (doctors and patients know which drug is being administered), Phase IIIb clinical trial to evaluate differences in effectiveness, safety, and tolerability of darunavir/ritonavir by sex and/or race over a 48-week treatment period. This study will be conducted in HIV positive women and ... | HIV Infectious | HIV AIDS Immunodeficiency Virus, Human Females Women PREZISTA darunavir TMC114 Protease Inhibitor | null | 1 | arm 1: darunavir 600mg bid for 48 wks,ritonavir 100mg bid for 48 wks | [
0
] | 2 | [
0,
0
] | intervention 1: 600mg bid for 48 wks intervention 2: 100mg bid for 48 wks | intervention 1: darunavir intervention 2: ritonavir | 46 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
Torrance | California | United States | -118.34063 | 33.83585
Washington D... | 1 | NCT00381303 |
[
5
] | 8,424 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period | null | Asthma | Asthma | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: Budesonide/formoterol | 817 | Aalst | N/A | Belgium | 4.0355 | 50.93604
Aarschot | N/A | Belgium | 4.83695 | 50.98715
Aatrijken | N/A | Belgium | N/A | N/A
Asse | N/A | Belgium | 4.19836 | 50.91011
Balen | N/A | Belgium | 5.17027 | 51.16837
Bastogne | N/A | Belgium | 5.71844 | 50.00347
Bellaire | N/A | Belgium | 5.66585 | 50.64453
Betrix | N/A | Be... | 0 | NCT00463866 |
[
3,
4
] | 253 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin | null | Stage IIIB or IV Non-Small Cell Lung Cancer | null | 2 | arm 1: vorinostat; IV paclitaxel; IV carboplatin arm 2: Placebo; IV paclitaxel; IV carboplatin | [
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: vorinostat 400 mg capsules once daily. Up to 6 months of treatment intervention 2: intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment intervention 3: intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment. intervention 4: vorinostat 400 mg placebo capsules once daily. U... | intervention 1: vorinostat intervention 2: Comparator: paclitaxel intervention 3: Comparator: carboplatin intervention 4: Comparator: placebo | 0 | null | 1 | NCT00473889 | |
[
4
] | 298 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilize... | null | Bipolar Disorder Depression, Bipolar | null | 2 | arm 1: Active treatment, double-blind, randomized treatment arm arm 2: Inactive, placebo treatment, double-blind, randomized arm | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to ... | intervention 1: Ziprasidone intervention 2: Placebo | 70 | Chandler | Arizona | United States | -111.84125 | 33.30616
Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Springdale | Arkansas | United States | -94.12881 | 36.18674
Costa Mesa... | 1 | NCT00483548 | |
[
4
] | 395 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease | This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa | Advanced Stage Parkinson's Disease | Rotigotine Neupro® | null | 1 | arm 1: Rotigotine | [
0
] | 1 | [
0
] | intervention 1: Rotigotine trans-dermal patches once daily:
20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours) | intervention 1: Rotigotine | 53 | Bedford Park | N/A | Australia | 138.56815 | -35.02204
Concord | N/A | Australia | 151.10381 | -33.84722
Darlinghurst | N/A | Australia | 151.21925 | -33.87939
East Gosford | N/A | Australia | 151.35338 | -33.43874
Westmead | N/A | Australia | 150.98768 | -33.80383
Innsbruck | N/A | Austria | 11.39454 | 47.26266
Zagreb... | 1 | NCT00501969 |
[
4
] | 712 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.
The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis. | The decision to discontinue the trial is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial. | Chronic Kidney Disease End-Stage Renal Disease | null | 2 | arm 1: Somatropin once daily from week 0 to end of trial arm 2: Placebo once daily to end of trial | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 20 mcg/kg/day, injected s.c. (under the skin) intervention 2: Placebo injected s.c (under the skin) | intervention 1: somatropin intervention 2: placebo | 381 | Alexander City | Alabama | United States | -85.95385 | 32.94401
Birmingham | Alabama | United States | -86.80249 | 33.52066
Madison | Alabama | United States | -86.74833 | 34.69926
Mobile | Alabama | United States | -88.04305 | 30.69436
Mobile | Alabama | United States | -88.04305 | 30.69436
Montgomery | Alabama | Unit... | 1 | NCT00503698 | |
[
4
] | 480 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy. | null | Epilepsy | Epilepsy Brivaracetam Partial Onset Seizures | null | 2 | arm 1: Matching Placebo tablets administered twice a day arm 2: A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period intervention 2: Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day... | intervention 1: Placebo intervention 2: Brivaracetam | 61 | Graz | N/A | Austria | 15.45 | 47.06667
Innsbrick | N/A | Austria | N/A | N/A
Linz | N/A | Austria | 14.28611 | 48.30639
Vienna | N/A | Austria | 16.37208 | 48.20849
Bruges | N/A | Belgium | 3.22424 | 51.20892
Godinne | N/A | Belgium | 4.87364 | 50.34809
Leuven | N/A | Belgium | 4.70093 | 50.87959
Montignies-sur-Sambre... | 1 | NCT00504881 |
[
4
] | 258 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease. | This is the open-label extension to the randomized, double-blind, placebo-controlled SP650 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease who are not well-controlled on Levodopa. | Parkinson's Disease | Rotigotine Neupro | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Rotigotine transdermal patches:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
Optimal dosing:
During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours.
After the first year: Allowed dose increase of Rotigotine up to a maximum of 16 ... | intervention 1: Rotigotine | 41 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Fountain Valley | California ... | 1 | NCT00594386 |
[
4
] | 611 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder. | The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.
The study enrolled 611 patients. Participants were randomly assigned (b... | Major Depressive Disorder | Major Depressive Disorder Depression Drug Therapy Major Depressive Episode | null | 4 | arm 1: Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily,... | [
0,
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Encapsulated vortioxetine immediate-release tablets intervention 2: Duloxetine capsules intervention 3: Placebo-matching capsules | intervention 1: Vortioxetine intervention 2: Duloxetine intervention 3: Placebo | 38 | Beverly Hills | California | United States | -118.40036 | 34.07362
Irvine | California | United States | -117.82311 | 33.66946
Santa Ana | California | United States | -117.86783 | 33.74557
Torrance | California | United States | -118.34063 | 33.83585
Upland | California | United States | -117.64839 | 34.09751
Bradento... | 1 | NCT00672620 |
[
3
] | 39 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | RATIONALE: Thalidomide may stop the growth of colorectal cancer by stopping blood flow to the tumor. Giving thalidomide after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying surgery and thalidomide to see how well they work compared to surgery alone in treating patients ... | OBJECTIVES:
* Compare the disease-free survival probability in patients with previously resected recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs placebo.
* Compare the time to recurrence in patients treated with these regimens.
* Determine whether serum/plasma levels of vascular endot... | Colorectal Cancer | stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer | null | 2 | arm 1: Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose). arm 2: Patients receive oral placebo once daily. | [
0,
2
] | 3 | [
0,
3,
10
] | intervention 1: oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose). intervention 2: Initial dose: 100 mg by mouth (po) every bedtime ( Q hs) for four weeks, then progress to 200 mg po Q hs for four weeks, t... | intervention 1: thalidomide intervention 2: adjuvant therapy intervention 3: Placebo | 6 | Goshen | Indiana | United States | -85.83444 | 41.58227
Bethesda | Maryland | United States | -77.10026 | 38.98067
Bethesda | Maryland | United States | -77.10026 | 38.98067
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Pittsburgh | Pennsy... | 0 | NCT00019747 |
[
4
] | 379 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania. | Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their response to the medication. When the study is complete, care will be transferred to the child's treating psychiatrist. | Bipolar Disorder | Mania | null | 3 | arm 1: Participants will receive treatment with lithium for 8 to 16 weeks arm 2: Participants will receive treatment with valproate for 8 to 16 weeks arm 3: Participants will receive treatment with risperidone for 8 to 16 weeks | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Titrated until blood level is 1.1 to 1.3 mEq/L intervention 2: Titrated until blood level is 111 to 125 ug/mL intervention 3: Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID | intervention 1: Lithium carbonate intervention 2: Valproate intervention 3: Risperidone | 5 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Baltimore | Maryland | United States | -76.61219 | 39.29038
St Louis | Missouri | United States | -90.19789 | 38.62727
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Galveston | Texas | United States | -94.7977 | 29.30135 | 0 | NCT00057681 |
[
2,
3
] | 64 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small cell lung cancer and other solid tumors. | The Phase II efficacy expansion was restricted to SCLC patients with relapsed disease and the MTD was determined by the Phase I portion of the trial (60mg/m2). | Small Cell Lung Cancer | null | 7 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: Phase I and Phase II were consecutive and sequential. Different patients received the 60mg/m2 dose in Phase I and in Phase II. arm 6: None arm 7: None | [
0,
0,
0,
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease. | intervention 1: BB-10901 | 11 | Denver | Colorado | United States | -104.9847 | 39.73915
Ocoee | Florida | United States | -81.54396 | 28.56917
Springfield | Massachusetts | United States | -72.58981 | 42.10148
Albany | New York | United States | -73.75623 | 42.65258
Colombus | Ohio | United States | N/A | N/A
Kettering | Ohio | United States | -84.1... | 0 | NCT00065429 | |
[
3
] | 39 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how well giving oxaliplatin together with irinotecan and ... | PRIMARY OBJECTIVES:
I. To assess the total response rate of the oxaliplatin, irinotecan and capecitabine drug combination in advanced gastric/esophageal junction carcinoma.
II. To assess the duration of total responses of the oxaliplatin, irinotecan and capecitabine drug combination in advanced gastric/esophageal jun... | Adenocarcinoma of the Gastroesophageal Junction Diffuse Adenocarcinoma of the Stomach Intestinal Adenocarcinoma of the Stomach Mixed Adenocarcinoma of the Stomach Recurrent Gastric Cancer Stage IIIA Gastric Cancer Stage IIIB Gastric Cancer Stage IIIC Gastric Cancer Stage IV Gastric Cancer | null | 1 | arm 1: Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Given orally | intervention 1: oxaliplatin intervention 2: irinotecan hydrochloride intervention 3: capecitabine | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00084617 | |
[
3
] | 27 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with capecitabine may kill more tumor ce... | OBJECTIVES:
* Determine the confirmed complete and partial response rate in women with progressive stage IV adenocarcinoma of the breast treated with imatinib mesylate and capecitabine.
* Determine the 6-month progression-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in ... | Breast Cancer | stage IV breast cancer recurrent breast cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle intervention 2: 400 mg by mouth daily | intervention 1: Capecitabine intervention 2: Imatinib mesylate | 0 | null | 0 | NCT00087152 |
[
4
] | 751 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer. | This is a randomized (the study medication is assigned by a random order), active control (study medication will be compared with available standard care of treatment), parallel-group (each treatment group will be treated simultaneously at the same time and each participant only receives one treatment regimen as assign... | Breast Cancer | Breast Cancer Advanced breast cancer Breast Tumors Cancer of Breast Human Mammary Carcinoma Mammary Neoplasms, Human DOXIL Docetaxel | null | 2 | arm 1: DOXIL and docetaxel combination therapy: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. arm 2: Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion o... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle intervention 2: DOXIL 30 mg... | intervention 1: Docetaxel intervention 2: DOXIL | 147 | Hoover | Alabama | United States | -86.81138 | 33.40539
Fountain Valley | California | United States | -117.95367 | 33.70918
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Palm Springs | California | United States | -116.54529 | 33.8303
N... | 0 | NCT00091442 |
[
3
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transport... | The object of this study is to determine the safety and efficacy of nitric oxide for inhalation in the treatment of vaso-occlusive pain crisis (VOC) in patients with sickle cell disease. The study population will include patients with sickle cell disease (SS, S-beta-Thalassemia) presenting with vaso-occlusive pain cris... | Anemia, Sickle Cell | Blood Flow Nitric Oxide Pain Crisis Sickle Cell Anemia Vaso-Occlusive Crisis Sickle Cell Disease SCD | null | 2 | arm 1: Participants receive Inhaled nitric oxide (INO) arm 2: Participants receive Nitrogen gas | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Nitric oxide will be delivered for 4 hours at 80 ppm through a face mask. The dose will then be reduced to 40 ppm for 4 hours. After a total of 8 hours of treatment through face mask, the patient will get 6 mL/puls/breath of NO at 800 ppm or 3 m//pulse/breath, depending on patient weight. intervention 2... | intervention 1: Nitric Oxide intervention 2: Placebo | 11 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Oakland | California | United States | -122.2708 | 37.80437
Aurora | Colorado | United States | -104.83192 | 39.72943
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Baltimore | Maryland | United States | -76.61219 | 39.29038
Beth... | 0 | NCT00094887 |
[
3
] | 102 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients (pts) received ro... | Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria \[OPDREC\]) that included cutaneous manifestations of disease, lymph node involvement, and circulating malignant T-cells (Sézary cells). Skin involvement was measured using a weighted body surface area s... | Cutaneous T-cell Lymphoma | romidepsin | null | 0 | null | null | 1 | [
0
] | intervention 1: Study patients received romidepsin at a dose of 14 mg/m\^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although patients who showed an objective response or stable disease could continue to receive therapy, at the discretion of the in... | intervention 1: romidepsin (depsipeptide, FK228) | 11 | Los Angeles | California | United States | -118.24368 | 34.05223
Stanford | California | United States | -122.16608 | 37.42411
Boston | Massachusetts | United States | -71.05977 | 42.35843
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Nashville | Tennessee | United States | -86.78444 | 36.16589
Hou... | 0 | NCT00106431 |
[
5
] | 10 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD). | BACKGROUND:
SCD is a common disorder among African Americans and other minority groups. It is characterized by chronic anemia and episodic vaso-occlusive crises. The most common of these crises is the painful crisis. Current treatment of the painful crisis includes rest, hydration, and analgesic medication. Morphine i... | Hematologic Diseases Anemia, Sickle Cell | Blood Diseases Sickle Cell Anemia | null | 2 | arm 1: Intravenous ketorolac and oral placebo arm 2: Intravenous placebo and oral ibuprofen | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Intravenous ketorolac intervention 2: Ibuprofen, taken orally | intervention 1: Intravenous Ketorolac intervention 2: Ibuprofen | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00115336 |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in differen... | OBJECTIVES:
Primary
* Determine the antitumor activity of trastuzumab (Herceptin\^®), docetaxel, and carboplatin, as measured by tumor response rate, in women with previously untreated HER2/neu-positive stage IIB, IIIA, IIIB, or IIIC or inflammatory breast cancer.
Secondary
* Determine the pathological complete res... | Breast Cancer | inflammatory breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer | null | 1 | arm 1: A total of six cycles of TCH \[(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)\] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.
* Those determined to have localized and operable disea... | [
0
] | 5 | [
2,
0,
0,
3,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: Modified radical mastectomy or lumpectomy and axillary node dissection intervention 5: Whole breast or chest wall irradiation (as determined by radiologist) | intervention 1: herceptin intervention 2: carboplatin intervention 3: docetaxel intervention 4: conventional surgery intervention 5: radiation therapy | 9 | East Brunswick | New Jersey | United States | -74.41598 | 40.42788
Freehold | New Jersey | United States | -74.27376 | 40.26011
Hamilton | New Jersey | United States | -74.08125 | 40.20706
Montclair | New Jersey | United States | -74.20903 | 40.82593
Morristown | New Jersey | United States | -74.48154 | 40.79677
New Br... | 0 | NCT00118053 |
[
5
] | 293 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1... | null | Liver Transplantation | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1-1.5 g orally or intravenously twice daily intervention 2: As prescribed, for 12 months intervention 3: As prescribed, for 12 months intervention 4: 2-4 mg orally once daily for 9-11 months | intervention 1: mycophenolate mofetil [CellCept] intervention 2: Tacrolimus intervention 3: Cyclosporine intervention 4: Sirolimus | 46 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego |... | 0 | NCT00118742 | |
[
5
] | 109 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycl... | null | Breast Cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: 1000 mg/m² PO BID on Days 1-15 of each 3-week cycle intervention 2: 15 mg IV on Day 1 of each 3-week cycle | intervention 1: Capecitabine intervention 2: Bevacizumab | 57 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama... | 0 | NCT00121836 | |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The opiate neurotransmitter system is thought to be involved in many abnormal mood states. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. One problem with most of the currently available opiate medications is that they can prod... | Opiates have a long history of treating mood disorders. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. The clinical use of opiate medications has been limited by their abuse/dependence potential. Studies of opiate receptor subt... | Bipolar Disorder | bipolar disorder mania manic state opiate kappa | null | 1 | arm 1: Talwin NX | [
0
] | 1 | [
0
] | intervention 1: Talwin NX 50mg po twice | intervention 1: Talwin Nx | 0 | null | 0 | NCT00125931 |
[
4
] | 587 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | true | 0ALL | true | The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcomes in subjects with heart failure and in comparison to subjects without cardiovascular disease. | null | Heart Failure, Congestive | Heart Failure nuclear cardiology sympathetic innervation 123I-mIBG | null | 1 | arm 1: Single dose | [
0
] | 1 | [
0
] | intervention 1: Single dose | intervention 1: 123I-mIBG (meta-iodobenzylguanidine) | 1 | Princeton | New Jersey | United States | -74.65905 | 40.34872 | 0 | NCT00126425 |
[
4
] | 145 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to investigate the added benefits of increased high-density lipoprotein (HDL) cholesterol serum levels over and above those achieved by lipid lowering therapy guided by current guidelines, in older individuals with cardiovascular disease. | The hypothesis being tested is that the current standard lipid lowering therapy, combined with a 20 percent or greater increase in serum HDL induced by long-acting niacin, reduces plaque size in older individuals with cardiovascular disease. The specific aims of testing this hypothesis are:
1. to determine the effects... | Atherosclerosis Cardiovascular Disease | atherosclerotic plaque MRI inflammatory markers statins | null | 2 | arm 1: any statin plus niacin arm 2: any statin plus placebo | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 mo... | intervention 1: any statin intervention 2: niacin intervention 3: Placebo | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00127218 |
[
4
] | 635 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.
This study included a 2-year comparative treatment period followed by a 6-month follow-up peri... | Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171029 was terminat... | Diabetes Mellitus | null | 2 | arm 1: Inhalable short-acting insulin arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Inhaled insulin with dose adjusted according to premeal blood glucose intervention 2: Subcutaneous insulin with dose adjusted according to premeal blood glucose | intervention 1: Inhaled Insulin intervention 2: Subcutaneous insulin | 92 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Fresno | California | United States | -119.77237 | 36.74773
Greenbrae | California | United States | -122.5247 | 37.94854
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | Calif... | 0 | NCT00136916 | |
[
4
] | 582 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).
This study included a 2-year comparative treatment perio... | Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171022 was terminat... | Diabetes Mellitus, Type 1 | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Subcutaneous insulin with dose adjusted according to premeal blood glucose intervention 2: Inhaled insulin with dose adjusted according to premeal blood glucose | intervention 1: Subcutaneous Insulin intervention 2: Inhaled Insulin | 73 | Fullerton | California | United States | -117.92534 | 33.87029
Long Beach | California | United States | -118.18923 | 33.76696
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Santa Barbara | California | United States | -119.69819 | 34.42083
... | 0 | NCT00137046 | |
[
3
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cel... | PRIMARY OBJECTIVES:
I. To evaluate the response of non-small cell lung cancer to SAHA in the second line setting by applying RECIST criteria.
SECONDARY OBJECTIVES:
I. To estimate the time to progression and overall survival in this patient population.
II. To examine the toxicity profile of SAHA.
TERTIARY OBJECTIVE... | Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer | null | 1 | arm 1: Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 2 | [
0,
10
] | intervention 1: Given PO intervention 2: Correlative studies | intervention 1: vorinostat intervention 2: laboratory biomarker analysis | 5 | Green Bay | Wisconsin | United States | -88.01983 | 44.51916
La Crosse | Wisconsin | United States | -91.23958 | 43.80136
Madison | Wisconsin | United States | -89.40123 | 43.07305
Madison | Wisconsin | United States | -89.40123 | 43.07305
Manitowoc | Wisconsin | United States | -87.65758 | 44.08861 | 0 | NCT00138203 | |
[
4
] | 485 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC). | null | Small Cell Lung Carcinoma | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle intervention 2: irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle | intervention 1: Etoposide + cisplatin intervention 2: Irinotecan + cisplatin | 67 | Wels | N/A | Austria | 14.03333 | 48.16667
Ghent | N/A | Belgium | 3.71667 | 51.05
Leuven | N/A | Belgium | 4.70093 | 50.87959
Liège | N/A | Belgium | 5.56749 | 50.63373
Brno-Bohunice | N/A | Czechia | N/A | N/A
Olomouc | N/A | Czechia | 17.25175 | 49.59552
Ostrava - Poruba | N/A | Czechia | N/A | N/A
Prague | N/A | Cz... | 0 | NCT00143455 | |
[
4
] | 468 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of neg... | null | Schizophrenia | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 5-10 mg sublingually twice daily for up to 26 weeks intervention 2: 5-20 mg by mouth once daily for up to 26 weeks | intervention 1: Asenapine intervention 2: Olanzapine | 0 | null | 0 | NCT00145496 | |
[
2,
3
] | 32 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver.
Stage 2 is to evaluate the dose found in... | This study is designed to evaluate the effects of repeated treatments with NV1020, prior to second-line chemotherapy, and to determine an appropriate dose level of NV1020 in a multiple dose regimen for later Phase II studies.
Sequential, open-label cohort dose escalation of NV1020 (stage 1) followed by an expansion of... | Colorectal Cancer Liver Neoplasms | Colorectal cancer metastases to liver Colorectal Cancer Colorectal Carcinoma Colorectal Tumors Colorectal Neoplasms Rectum Cancer Rectum tumors Rectum carcinoma Colon cancer Colon tumors Colon carcinoma Rectum Neoplasms Colon Neoplasms Liver Neoplasms Hepatic Neoplasms Liver Tumors Liver cancer Hepatic Cancer Hepatic t... | null | 1 | arm 1: Stage 1: Four escalating dose cohorts of NV1020 3x10\^6 pfu, 1x10\^7 pfu, 3x10\^7 pfu, and 1x10\^8 pfu administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks followed by 2 cycles of chemotherapy.
Stage 2: Expansion of one dose cohort from Stage 1 of optimal NV1020 d... | [
0
] | 1 | [
0
] | intervention 1: NV1020 dose levels: 3x10\^6, 1x10\^7, 3x10\^7, and 1x10\^8 plaque forming units, administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks | intervention 1: NV1020 | 5 | San Diego | California | United States | -117.16472 | 32.71571
Boston | Massachusetts | United States | -71.05977 | 42.35843
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Nashville | Tennessee | United States | -86.78444 | 36.16589
Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00149396 |
[
3,
4
] | 48 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary | null | Aspergillosis | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Voriconazole oral : loading dose on day 1 : 400mg/12 hours; maintenance dose 200 mg /12 hours for 6 to 12 months depending on clinical response.
Alternatively, patients may start on Voriconazole, IV, for 7 days loading dose, 6mg/Kg/12 hours on day one and maintenance dose 4 mg/Kg/12 hours | intervention 1: Voriconazole | 18 | Nantes | Cedex | France | -1.55336 | 47.21725
Angers | N/A | France | -0.55202 | 47.47156
Bobigny | N/A | France | 2.45012 | 48.90982
Brest | N/A | France | -4.48628 | 48.39029
Bris Sous Forges | N/A | France | N/A | N/A
Caen | N/A | France | -0.35912 | 49.18585
Dinan | N/A | France | -2.05049 | 48.45553
Grenoble | N/A... | 0 | NCT00159822 | |
[
2,
3
] | 16 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine whether thymic shielding during total body irradiation can be given and whether it will reduce the risk of infections in Fanconi Anemia patients undergoing alternate donor (not a matched sibling) stem cell transplants. | All subjects will be given the same treatment regimen of total body irradiation (TBI), Fludarabine, Cyclophosphamide, and anti-thymocyte globulin (ATG), followed by an alternate donor stem cell transplant. Since this treatment regimen has been given before, without thymic shielding, we will compare the outcomes of thes... | Fanconi Anemia | Stem Cell Transplant Thymic Shielding Total Body Irradiation Chemotherapy | null | 1 | arm 1: Patients who received total body irradiation (450 cGy \[centigray\]) with thymic shielding prior to chemotherapy regimen and Hematopoietic Stem Cell Transplant (HSCT) | [
0
] | 4 | [
3,
3,
3,
0
] | intervention 1: Bone marrow failure may be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease. As one of its effects, this treatment al... | intervention 1: Hematopoietic Stem Cell Transplant intervention 2: Thymic Shielding During Radiation intervention 3: Total Body Irradiation intervention 4: Cyclophosphamide, Fludarabine | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00167206 |
[
0
] | 164 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This study will determine the metabolic processes responsible for high levels of blood glucose, metabolism disorders, and weight gain in people with schizophrenia who have been treated with antipsychotic medications in combination with valproate. | This project aims to study the whole-body metabolic processes responsible for hyperglycemia, dyslipidemia and increased adiposity in schizophrenia patients treated with antipsychotic medications in combination with valproate. The project hypothesizes that combined treatment with valproate and antipsychotic medications ... | Schizophrenia | Diabetes Metabolic | null | 2 | arm 1: 50% of participants will receive placebo arm 2: 50% of participants will receive Depakote ER | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Depakote ER 500 mg to 3000 mg taken every night intervention 2: Placebo given at same frequency as Valproate | intervention 1: Valproate intervention 2: Placebo | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00167934 |
[
3
] | 23 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study the use of transdermal... | null | Prostate Cancer | prostate cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact ar... | intervention 1: Transdermal Estradiol | 6 | Freehold | New Jersey | United States | -74.27376 | 40.26011
Hamilton | New Jersey | United States | -74.08125 | 40.20706
Morristown | New Jersey | United States | -74.48154 | 40.79677
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
Sum... | 0 | NCT00176644 |
[
3
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. | This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. Docetaxel 30mg/m2 will be administered on days 1 and 8 of each cycle and capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orall... | Cancer | gastric stomach esophagus esophageal | null | 1 | arm 1: Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity... | [
0
] | 2 | [
0,
0
] | intervention 1: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22. intervention 2: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21... | intervention 1: Docetaxel intervention 2: Capecitabine | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00177255 |
[
3
] | 742 | RANDOMIZED | PARALLEL | 1PREVENTION | 1SINGLE | false | 1FEMALE | false | The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike excep... | The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Although the title of the study describes "open", it was in fact single-blinded.
Issues on side effects are addresse... | Contraception | null | 3 | arm 1: Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro arm 2: Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro arm 3: Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years intervention 2: Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years intervention 3: Levonorgestrel Intrauterine contracept... | intervention 1: Levonorgestrel IUS (BAY86-5028, G04209B) intervention 2: Levonorgestrel IUS (BAY86-5028, G04209C) intervention 3: Levonorgestrel IUS (Mirena, BAY86-5028) | 35 | Espoo | N/A | Finland | 24.6522 | 60.2052
Helsinki | N/A | Finland | 24.93545 | 60.16952
Joensuu | N/A | Finland | 29.76316 | 62.60118
Jyväskylä | N/A | Finland | 25.72088 | 62.24147
Kotka | N/A | Finland | 26.94582 | 60.4664
Kuopio | N/A | Finland | 27.67703 | 62.89238
Lahti | N/A | Finland | 25.66151 | 60.98267
Oulu ... | 0 | NCT00185380 | |
[
3
] | 75 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with rad... | Upon determination of eligibility, patients will receive:
Pre-operative
* Docetaxel
* Gemcitabine Post-operative
* Docetaxel
* Carboplatin
* Radiation Therapy
Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of ... | Lung Cancer | null | 1 | arm 1: Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or ... | [
0
] | 4 | [
0,
0,
0,
4
] | intervention 1: 30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles intervention 2: 1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles intervention 3: AUC = 1.5 weekly x 7 intervention 4: To 63 Gy | intervention 1: Docetaxel intervention 2: Gemcitabine intervention 3: Carboplatin intervention 4: Radiation | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00193427 | |
[
0
] | 64 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this research was to test whether one treatment was superior over another in the management of type 1.5 diabetes. Specifically we tested recently diagnosed antibody positive type 2 diabetic patients to determine whether treatment with rosiglitazone results in greater preservation of beta cell function co... | Type 1 diabetes and Type 2 diabetes have different underlying pathophysiologic processes. The disease process in classical Type 1 diabetes is an autoimmune destruction of the pancreatic beta cells. In contrast, the disease process in classical Type 2 diabetes is not autoimmune in nature, a decreased sensitivity to insu... | Type 2 Diabetes Mellitus | type 2 diabetes mellitus autoantibodies islet proteins rosiglitazone glyburide c-peptide | null | 2 | arm 1: Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. arm 2: Glyburide is a sulfonylurea. Glyburide therapy was ini... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Tablet taken orally at a dosage of 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Study drug was taken up to 3 years. intervention 2: Tablet taken orally, initially 2.5 mg in the morning or dose subject received prior to starting the study. Dosage was incr... | intervention 1: rosiglitazone intervention 2: glyburide | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00194896 |
[
4
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or obsessi... | This study consists of three phases: Screening/Washout Phase, Double-Blind Phase and Taper Phase.
SCREENING/WASHOUT PHASE: Your study doctor or his staff will review with you any medications that you are currently taking and may instruct you, if appropriate, to discontinue taking certain medications. Your study doctor... | Tourette Syndrome | null | 2 | arm 1: Placebo or sugar pill arm 2: Topiramate 25 mg to 200 mg | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Topiramate 25 mg titrated to 200 mg intervention 2: placebo | intervention 1: Topiramate (drug) intervention 2: placebo/sugar pill | 0 | null | 0 | NCT00206323 | |
[
4
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or obsessi... | In order to enroll in this study, you must have completed the Double-Blind phase of CAPSS-176 or discontinued the Double-Blind phase of CAPSS-176 after a minimum of 6 weeks because it has been determined that your symptoms of Tourette Syndrome were getting worse. You must also continue to meet the specific inclusion an... | Tourette Syndrome | null | 1 | arm 1: Topiramate open label | [
0
] | 1 | [
0
] | intervention 1: Topiramate 25 mg to 200 mg | intervention 1: Topiramate (drug) | 0 | null | 0 | NCT00206336 | |
[
2,
3
] | 36 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this... | OUTLINE: This is a multi-center study.
Week 1 (day 1):
* Cetuximab 400mg/m2
Week 2 (Cycle 1, Day 1):
* Cetuximab 250mg/m2 plus premetrexed at the assigned dose level.
Patients will be treated with cetuximab on day 1, 8, 15 of each 21 day cycle.
Patients will be treated with pemetrexed on day 1 of each 21 day cycl... | Non-Small Cell Lung Cancer | Non-Small Cell Lung Cancer | null | 1 | arm 1: Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer. | [
0
] | 2 | [
0,
0
] | intervention 1: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles intervention 2: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle | intervention 1: Pemetrexed intervention 2: Cetuximab | 11 | Galesburg | Illinois | United States | -90.37124 | 40.94782
Bloomington | Indiana | United States | -86.52639 | 39.16533
Elkhart | Indiana | United States | -85.97667 | 41.68199
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Goshen | Indiana | United States | -85.83444 | 41.58227
Indianapolis | Indiana | Un... | 0 | NCT00216203 |
[
3
] | 52 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study will evaluate the efficacy and safety of chemotherapy given prior to having lung cancer surgically removed. Patients with resectable non-small cell lung cancer will receive gemcitabine and pemetrexed together for 4 times biweekly. Patients will be seen by a medical oncologist prior to each cycle of chemother... | This study will evaluate the efficacy and safety of neoadjuvant chemotherapy with gemcitabine and pemetrexed given together 4-times biweekly in patients with resectable NSCLC. All patients will be seen by members of the Thoracic Oncology Program at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Flori... | Lung Cancer | Non-Small-Cell Lung Cancer resectable NSCLC | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
3
] | intervention 1: Gemcitabine (GemzarR) 1500 mg/m2 intervention 2: Pemetrexed (AlimtaR) 500 mg/m2 intervention 3: When the chemotherapy treatment is completed, the patient's tumor response will be evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). If there... | intervention 1: Gemcitabine intervention 2: Pemetrexed intervention 3: Surgery | 1 | Tampa | Florida | United States | -82.45843 | 27.94752 | 0 | NCT00226577 |
[
4
] | 136 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | null | The study evaluated the efficacy and safety of a prolonged, continuous course of Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the standard of care upon initiation of the study, to 12 months of Valganciclovir. | A multi-center two phase, double-blind, placebo controlled, randomized prospective study of 130 lung transplant recipients. Patients will be screened and consented prior to transplant. All consented patients will receive IV ganciclovir within 24 hours of transplant for not more than 14 days. Patients will enroll in Pha... | Cytomegalovirus Infections | Acute rejection Non-CMV infections Resistance | null | 2 | arm 1: Valganciclovir 900 mg QD for 9 months post lung transplant. arm 2: placebo for 9 months post lung transplant | [
1,
2
] | 2 | [
0,
10
] | intervention 1: valgan 900mg QD x 9 months post lung transplant intervention 2: None | intervention 1: valganciclovir intervention 2: Placebo | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00227370 |
[
3
] | 21 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | null | Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI. | Purpose: The purpose of this study is to examine the efficacy of the drug modafinil as a treatment for fatigue post TBI.
Background: After TBI, fatigue is one of the most common complaints, as documented in our work and that of many other researchers. People with TBI experience fatigue that seems to them out of propor... | Fatigue | Fatigue TBI brain injury Modafinil traumatic brain injury | null | 2 | arm 1: single dose of 200 mg. a day of modafinil for four weeks arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: single dose of 200 mg. a day of modafinil for four weeks intervention 2: daily dose of placebo for four weeks. | intervention 1: Modafinil intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00233090 |
[
5
] | 2,800 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-gro... | null | Cerebral Infarction | null | 2 | arm 1: cilostazol arm 2: Aspirin | [
0,
1
] | 2 | [
0,
0
] | intervention 1: oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years intervention 2: oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years | intervention 1: Cilostazol intervention 2: Aspirin | 1 | Tokyo | N/A | Japan | 139.69171 | 35.6895 | 0 | NCT00234065 | |
[
3
] | 45 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Cisplatin is a very important agent for the treatment of TCC as it has a single agent response rate of approximately 15%. However, it has been most important as a part of combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single agent gemcitabine has demonstrated an overall response rate ... | OUTLINE: This is a multi-center study.
* Cisplatin 70 mg/m2 Day 1
* Gemcitabine 1250 mg/m2 Day 1 and 8
* Bevacizumab 15 mg/kg Day 1
Review toxicity every cycle (every 3 weeks) Review for radiographic response every 2 cycles (every six weeks)
Progressive disease = off protocol therapy
Patients will be treated for up... | Bladder Cancer | null | 1 | arm 1: Cisplatin + Gemcitabine + Bevacizumab | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Cisplatin 70 mg/m2, day 1 intervention 2: Gemcitabine 1250 mg/m2, day 1 and 8 intervention 3: Bevacizumab 15mg/kg, day 1 | intervention 1: Cisplatin intervention 2: Gemcitabine intervention 3: Bevacizumab | 11 | Chicago | Illinois | United States | -87.65005 | 41.85003
Galesburg | Illinois | United States | -90.37124 | 40.94782
Evansville | Indiana | United States | -87.55585 | 37.97476
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Indianapolis | Indian... | 0 | NCT00234494 | |
[
3
] | 21 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study it to evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are \< 5 g/dL following high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). | To evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are \< 5 g/dL following high dose chemotherapy (HDCT) and Autologous Stem Cell Transplantation (ASCT).
To assess the time to progression and disease free survival... | Multiple Myeloma | Myeloma PTK | null | 1 | arm 1: Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in ... | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: PTK787/ZK 222584 | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00240162 |
[
5
] | 77 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (LAI) versus oral antipsychotics in participants with recent onset psychosis (abnormal thinking and/or hallucinations). | This is an open-label (all people know identity of intervention), randomized (the study drug is assigned by chance), multicenter (conducted in more than 1 center), and exploratory study in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality) or schizoaff... | Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Psychotic Disorders | Schizophrenia Schizoaffective disorder Schizophreniform disorder Risperidone Risperdal Consta | null | 2 | arm 1: Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. arm 2... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion. intervention 2: Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapi... | intervention 1: Risperidone long-acting injection (LAI) intervention 2: Oral Antipsychotic | 11 | Calgary | Alberta | Canada | -114.08529 | 51.05011
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Victoria | British Columbia | Canada | -123.35155 | 48.4359
Dartmouth | Nova Scotia | Canada | -63.57719 | 44.67134
Greater Sudbury | Ontario | Canada | -80.99001 | 46.49
Kingston | Ontario | Canada | -76.48098 | 44.2... | 0 | NCT00246259 |
[
5
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study will evaluate the safety and effectiveness of treatment with both a sleeping pill and antidepressant medication in improving sleep and psychological functioning in people with depression and insomnia. | Chronic insomnia is one of the most common symptoms that individuals experience during a major depressive episode. Insomnia may lead to increased risk for recurrence of major depression, as well as poor quality of life and increased risk of suicide. Studies have shown that treating insomnia during a major depressive ep... | Sleep Initiation and Maintenance Disorders Depression | Depression Hypnotics Sleep Quality of Life Insomnia Suicide | null | 2 | arm 1: Participants will receive treatment with eszopiclone and fluoxetine arm 2: Participants will receive treatment with placebo and fluoxetine | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Eszopiclone 3 mg every night for 8 weeks intervention 2: Fluoxetine 20 mg every morning for 9 weeks intervention 3: Placebo every night for 8 weeks | intervention 1: Eszopiclone intervention 2: Fluoxetine intervention 3: Placebo | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00247624 |
[
5
] | 266 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of thrombolytic therapy (TT) for the treatment of AMI in patients \>=75 years old with ST-segment elevation or LBBB AMI \<6 hours of evolution without contraindications for TT.
Hypothesis: The therapeutical strategy based on PA ... | Hypothesis of the study. In patients of 75 or more years of age with AMI and ST-elevation or LBBB, the treatment strategy based on primary angioplasty is superior to the treatment strategy based on initial fibrinolytic therapy for reducing the incidence of death, re-infarction and disabling CVA at 30 days. This benefit... | Acute Myocardial Infarction | Acute myocardial infarction Elderly Thrombolysis Primary angioplasty Randomized trial Efficacy Safety | null | 2 | arm 1: Weight adjusted tenecteplase bolus + Unfrationated heparin arm 2: Primary angioplasty | [
1,
1
] | 2 | [
0,
3
] | intervention 1: None intervention 2: None | intervention 1: Tenecteplase + UFH (+ clopidogrel, since 01/97) intervention 2: Primary angioplasty | 23 | Palma de Mallorca | Balearic Islands | Spain | 2.65024 | 39.56939
Barcelona | Barcelona | Spain | 2.15899 | 41.38879
Barcelona | Barcelona | Spain | 2.15899 | 41.38879
L'Hospitalet de Llobregat | Barcelona | Spain | 2.10028 | 41.35967
Santander | Cantabria | Spain | -3.80444 | 43.46472
Granada | Granada | Spain | -3.60... | 0 | NCT00257309 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.