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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 58 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer compared to historical data. The safety of this combination treatment will also be studied. | null | Metastatic Pancreatic Cancer | null | 1 | arm 1: All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour). | [
0
] | 2 | [
0,
0
] | intervention 1: Intravenous Infusion (IV), 32 mg/m\^2 every 21 days. intervention 2: Initial dose of 400 mg/m\^2 intravenous (IV) over 2 hours) followed by a weekly lower dose of 250 mg/m\^2 IV over 1 hour. | intervention 1: Ixabepilone intervention 2: Cetuximab | 9 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Jacksonville | Florida | United States | -81.65565 | 30.33218
Miami | Florida | United States | -80.19366 | 25.77427
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Detroit | Michigan | United States | -83.04575 | 42.33143
Columbi... | 0 | NCT00383149 | |
[
3
] | 47 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the symptoms of posttraumatic stress disorder (PTSD).
People between 18 and 65 years of age who have been diagnosed with PTSD may be eligib... | Posttraumatic Stress Disorder (PTSD) is a common chronic anxiety disorder that is often debilitating and follows exposure to an overwhelming traumatic event. The burden of PTSD on individuals and society is significant. The majority of PTSD sufferers also meet the diagnostic criteria for several other psychiatric disor... | PTSD | PTSD Substance P Treatment Study Placebo Controlled Post Traumatic Stress Disorder | null | 2 | arm 1: selective neurokinin-1 receptor antagonist, fixed 5 mg dose every day, for 8 weeks. arm 2: sugar pill | [
0,
2
] | 9 | [
0,
3,
3,
3,
3,
3,
3,
3,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None | intervention 1: NK1 Antagoist (GR205171) intervention 2: Psychophysiology (Trauma Script) intervention 3: Psychophysiology (Verbal Threat) intervention 4: Psychophysiology (Fear Conditioning) intervention 5: Psychophysiology (Affective Modulation) intervention 6: Psychophysiology (Heart rate variability) intervention 7... | 2 | Bethesda | Maryland | United States | -77.10026 | 38.98067
New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00383786 |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Third molar surgery is complicated by pain and swelling for several days after surgery. Non-steroidal antiinflammatory drugs have been useful in combination with opioids for treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine or placebo as a nasal spray before surgery to determi... | This is a randomized double blind cross-over study. In each of two sittings, the third molars on one side of the mouth are removed. In one sitting the subject will receive a nicotine nasal spray (3mg) and in the other placebo. VAS and narcotic utilization will be compared within patients. | Dental Crowding | Third Molar Pain | null | 2 | arm 1: In one sitting the subject will receive a nicotine nasal spray, 3 mg, one application. arm 2: In one sitting the subject will receive a placebo nasal spray (0 mg), one application. | [
1,
2
] | 2 | [
0,
10
] | intervention 1: Nicotine nasal spray 3mg x 1 before surgery intervention 2: Placebo nasal spray 0mg x 1 before surgery | intervention 1: Nicotine intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00385216 |
[
3
] | 102 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC). | null | Small Cell Lung Cancer | SCLC SALUTE Lung Cancer Avastin | null | 2 | arm 1: Chemotherapy = cisplatin (or carboplatin) + etoposide arm 2: Chemotherapy = cisplatin (or carboplatin) + etoposide | [
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. intervention 2: Chemotherapy = cisplatin (or carboplatin... | intervention 1: Bevacizumab intervention 2: Chemotherapy intervention 3: Placebo | 0 | null | 0 | NCT00403403 |
[
4
] | 233 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period. | null | Cervical Dystonia | null | 3 | arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution,... | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units) intervention 2: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units) interv... | intervention 1: incobotulinumtoxinA (Xeomin) (240 Units) intervention 2: incobotulinumtoxinA (Xeomin) (120 Units) intervention 3: Placebo | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00407030 | |
[
3
] | 85 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to compare the safety and efficacy of treating individuals with acute ischemic stroke with normobaric oxygen therapy (NBO, given within 9 hours of symptom onset), to standard medical treatment. | Stroke is the third leading cause of death and the leading cause of disability in the United States. Ischemic stroke is caused by a blockage of blood flow to one or more brain arteries, usually due to a blood clot. As a result there is a reduced supply of oxygen and other nutrients leading to permanent brain damage. No... | Ischemic Stroke | ischemic stroke normobaric oxygen therapy | null | 2 | arm 1: Oxygen, inhaled at 30-45L/min via a facemask for 8 hours arm 2: Room Air, inhaled at 30-45L/min via a facemask for 8 hours | [
1,
2
] | 2 | [
0,
0
] | intervention 1: High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours. intervention 2: Room Air delivered via a facemask. A total of 240 individuals with a... | intervention 1: NBO (Normobaric Oxygen) intervention 2: Room Air | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00414726 |
[
3
] | 239 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with cancer.
PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in t... | OBJECTIVES:
Primary
* Compare the relative efficacy of four different erythropoietic agent dosing schedules comprising epoetin alfa or darbepoetin alfa, in terms of the proportion of patients with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic response.
Secondary
* Compare the effect ... | Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific | unspecified adult solid tumor, protocol specific extramedullary plasmacytoma isolated plasmacytoma of bone refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma Waldenstrom macroglobulinemia post-transplant lymphoproliferative disorder stage I adult T-cell leukemia/ly... | null | 4 | arm 1: 40,000 Units arm 2: 80,000 Units arm 3: 120,000 Units arm 4: 500 mcg | [
0,
0,
0,
0
] | 4 | [
0,
0,
3,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: darbepoetin alfa intervention 2: epoetin alfa intervention 3: fatigue assessment and management intervention 4: quality-of-life assessment | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00416624 |
[
5
] | 313 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | null | 0ALL | null | The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic. | null | Kidney Transplantation | Renal, Kidney, Intensified, Enteric-coated mycophenolate sodium, Transplant | null | 2 | arm 1: In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment. arm 2: In patients r... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment. intervention 2: cyclosporine microemulsion in galenic form capsules starting a... | intervention 1: Enteric-coated mycophenolate sodium (Myfortic) intervention 2: Cyclosporine (Neoral) intervention 3: Prednisone | 1 | Basel | N/A | Switzerland | 7.57327 | 47.55839 | 0 | NCT00419926 |
[
5
] | 108 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum) | null | Chalazion Hordeolum | null | 2 | arm 1: 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension arm 2: Vehicle | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication. intervention 2: topical ophthalmic vehicle was applied 4 times a day... | intervention 1: loteprednol etabonate/tobramycin opthalmic suspension intervention 2: vehicle | 1 | Erie | Pennsylvania | United States | -80.08506 | 42.12922 | 0 | NCT00420628 | |
[
3
] | 281 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD) who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II rec... | null | Diabetic Nephropathy Chronic Kidney Disease | Type 2 Diabetic Nephropathy | null | 3 | arm 1: One paricalcitol 1 mcg capsule and one matching placebo capsule per dose arm 2: Two paricalcitol 1 mcg capsules per dose arm 3: Two placebo capsules per dose | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily) intervention 2: Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily) intervention 3: Group 1 - Placebo once daily (two placebo... | intervention 1: Zemplar (paricalcitol ) capsules intervention 2: Zemplar (paricalcitol) capsules intervention 3: Placebo | 72 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Fountain Valley | California | United States | -117.95367 | 33.70918
Yuba City | California | United States | -121.61691 | 39.14045
Hudson | Florida | United States | -82.69343 | 28.36445
Lauderdale Lakes | Florida | United States | -80.20838 | 26.16647
Pembroke... | 0 | NCT00421733 |
[
4
] | 573 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial. | The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-two (22) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting... | Fibromyalgia | FMS Fibro pain Body pain tenderness stiffness muscular pain joint pain | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Oral Solution intervention 2: two doses | intervention 1: placebo intervention 2: Xyrem® | 116 | Auburn | Alabama | United States | -85.48078 | 32.60986
Birmingham | Alabama | United States | -86.80249 | 33.52066
Montgomery | Alabama | United States | -86.29997 | 32.36681
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Burbank | California | Uni... | 0 | NCT00423813 |
[
2
] | 57 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the maximum tolerated dose and recommended phase 2 dose of PF-03814735 administered orally as single agent in patients with advanced solid tumors. | null | Solid Tumors | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 1, 5, and 25 mg gelatin capsules administered orally once a day from day 1 to day 5, or from day 1 to day 10 every 3 weeks until disease progression or unacceptable toxicity. | intervention 1: PF-03814735 | 2 | Nashville | Tennessee | United States | -86.78444 | 36.16589
Leuven | N/A | Belgium | 4.70093 | 50.87959 | 0 | NCT00424632 | |
[
3
] | 25 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the ... | OBJECTIVES:
Primary
* Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with bortezomib and docetaxel.
Secondary
* Determine the time to progression in patients treated with this regimen.
* Determine the toxicity of this regimen.
* ... | Head and Neck Cancer | stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hyp... | null | 1 | arm 1: Docetaxel (40 mg/m2) IV Infusion over 30 minutes every 3 weeks (Day 1 and 8 of 21 day cycle)except the first dose is held on Day 1 of Cycle 1.
Bortezomib (1.6mg/m2) IV 3-5 second push every 3 weeks (Day 1 and 8 of 21 day cycle).Bortezomib is given as a single agent only on Day 1 of Cycle 1. | [
0
] | 4 | [
0,
0,
10,
10
] | intervention 1: 1.6 mg/m2 through a vein on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1. intervention 2: 40 mg/m2 through a vein on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. intervention 3: Tissue and blood collection. i... | intervention 1: bortezomib intervention 2: docetaxel intervention 3: laboratory biomarker analysis intervention 4: pharmacological study | 7 | Hopkinsville | Kentucky | United States | -87.49117 | 36.86561
Paducah | Kentucky | United States | -88.60005 | 37.08339
Crossville | Tennessee | United States | -85.0269 | 35.94896
Jackson | Tennessee | United States | -88.81395 | 35.61452
Knoxville | Tennessee | United States | -83.92074 | 35.96064
Nashville | Tennes... | 0 | NCT00425750 |
[
2,
3
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable. | Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patie... | Lymphoma, Non-Hodgkin | Lymphoma, Non-Hodgkin, Low-Grade | null | 1 | arm 1: Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section | [
0
] | 2 | [
0,
0
] | intervention 1: starting with 60 mg/m\^ 2, IV, dose escalation, weekly d1,8,15 q5w intervention 2: weekly 1.5mg/m\^2, IV, d1,8,15,22 q5w | intervention 1: Bendamustine intervention 2: Bortezomib | 0 | null | 0 | NCT00426855 |
[
3
] | 15 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence. | This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT. | Substance-Related Disorders | cognitive-behavior therapy d-cycloserine cognitive enhancer drug dependence opiate dependence exposure isolated doses of d-cycloserine isolated doses of matching pill placebo DCS | null | 2 | arm 1: D-cycloserine-augmented CBT-IC arm 2: Placebo-augmented CBT-IC | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10) intervention 2: Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10) | intervention 1: D-cycloserine intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00430573 |
[
4
] | 803 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to compare the effect of adding alogliptin, once daily (QD), to the ongoing treatment regimen of pioglitazone HCl and metformin in patients with inadequate glycemic control. | Despite the introduction of new classes of medications for glycemic control, just over half of adults with type 2 diabetes mellitus (T2DM) achieve a glycosylated hemoglobin level less than 7.0%, the American Diabetes Association recommended glycosylated hemoglobin goal. The rising incidence of type 2 diabetes mellitus ... | Diabetes Mellitus | Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus, Lipoatrophic Dyslipidemia Hyperglycemia Drug Therapy | null | 2 | arm 1: Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks. arm 2: Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolera... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Alogliptin tablets. intervention 2: Pioglitazone tablets. intervention 3: Metformin HCl tablets (immediate-release, commercially available formulation) ≥1500 mg or maximum tolerated dose. intervention 4: Matching placebo tablets. | intervention 1: Alogliptin intervention 2: Pioglitazone intervention 3: Metformin intervention 4: Placebo | 86 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Lake Havasu City | Arizona | United States | -114.32245 | 34.4839
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Foothill Ranch | California | United States | -117.66088 | 33.68641
Los A... | 0 | NCT00432276 |
[
3
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma. | null | Allergic Asthma | AQUA anti-CD11 CD11a Asthma Allergy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Aged Liquid; subcutaneous repeating dose intervention 2: Lyophilized; subcutaneous repeating dose intervention 3: Subcutaneous repeating dose | intervention 1: omalizumab intervention 2: omalizumab intervention 3: placebo | 0 | null | 0 | NCT00434434 |
[
4
] | 494 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patien... | null | Type 2 Diabetes Mellitus | diabetes exenatide Byetta Amylin Lilly | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: subcutaneous injection (5 mcg or 10 mcg), twice a day intervention 2: subcutaneous injection (titrated appropriately), twice a day | intervention 1: exenatide twice daily (BID) intervention 2: premixed insulin aspart twice daily (BID) | 39 | Bad Mergentheim | N/A | Germany | 9.77361 | 49.4925
Berlin | N/A | Germany | 13.41053 | 52.52437
Bosenheim | N/A | Germany | 7.91382 | 49.84472
Burghausen | N/A | Germany | 12.83139 | 48.16925
Datteln | N/A | Germany | 7.3453 | 51.65598
Dresden | N/A | Germany | 13.73832 | 51.05089
Essen | N/A | Germany | 7.01228 | 51.... | 0 | NCT00434954 |
[
3
] | 64 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP). | This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study. The pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationship of avatrombopag will also be studied. Approximately 65 eligible participants will be randomized in a 3:3:3:3:1 ratio in a d... | Chronic Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic | Chronic Idiopathic Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura ITP | null | 2 | arm 1: 2.5, 5, 10 or 20 mg tablets
1 tablet taken orally once daily for 28 days arm 2: 2.5, 5, 10, or 20 mg tablets
1 tablet taken orally once daily for 28 days | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Placebo tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days. intervention 2: Avatrombopag tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days. | intervention 1: Placebo intervention 2: Avatrombopag tablets | 25 | Anaheim | California | United States | -117.9145 | 33.83529
Bakersfield | California | United States | -119.01871 | 35.37329
Concord | California | United States | -122.03107 | 37.97798
Fountain Valley | California | United States | -117.95367 | 33.70918
Orange | California | United States | -117.85311 | 33.78779
Manch... | 0 | NCT00441090 |
[
3
] | 30 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Participants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one of 2 arms based on the immunophenotype of their lymphoma.
(A)Participants with CD20(-) lymphoma will undergo mobilization with granulocyte colony-stimulating factor (G-CSF) and plerixafor.
(B) Participants with CD20(+) lympho... | This is a single-center, 2-arm, non-randomized, open-label study to evaluate the safety of plerixafor when used in combination with rituximab (Rituxan®) and granulocyte colony-stimulating factor (G-CSF) in patients with relapsed or refractory Hodgkin disease (HD) or non-Hodgkin lymphoma (NHL).
Participants will be ass... | Non-Hodgkin Lymphoma Hodgkin Disease | AMD3100 stem cell mobilization autologous transplant Non-Hodgkin Lymphoma Hodgkin Disease | null | 2 | arm 1: Participants with CD20- lymphoma arm 2: Participants with CD20+ lymphoma | [
0,
0
] | 3 | [
0,
0,
2
] | intervention 1: Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (sc) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morn... | intervention 1: G-CSF plus plerixafor intervention 2: G-CSF plus plerixafor intervention 3: rituximab | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00444912 |
[
3
] | 32 | NA | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | false | This Phase 2a, multicenter, open-label, dose-escalation study is designed to assess the safety and biologic activity of daily oral administration of 4 escalating doses of sapropterin dihydrochloride over 16 weeks in subjects with sickle cell disease. During an optional extension phase, the study will assess the safety,... | This Phase 2a, multicenter, open-label, dose-escalation study was designed to assess the safety and biological activity of once-daily (or twice-daily \[BID\], only for the highest dose level) oral administration of 4 escalating doses of sapropterin dihydrochloride to subjects with Sickle Cell Disease (SCD); 32 subjects... | Sickle Cell Disease | Sickle Cell Disease SCD 6R-BH4 BH4 sapropterin dihydrochloride endothelial dysfunction Nitric Oxide NO | null | 1 | arm 1: 2.5, 5, 10, 20 mg/kg/day of sapropterin dihydrochloride during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks, with an optional extension phase at the highest tolerated dose for up to a total of 2 years. | [
0
] | 1 | [
0
] | intervention 1: Subjects will receive oral, once-daily (for 2.5, 5, 10mg/kg/day doses) or twice-daily (for the 20 mg/kg/day dose) sapropterin dihydrochloride during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks as follows: 2.5, 5, 10, and 20 mg/kg/day. Dosing was with 100 mg... | intervention 1: Sapropterin Dihydrochloride | 12 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Augusta | Georgia | United States | -81.97484 | 33.47097
Savannah | Georgia | United States | -81.09983 | 32.08354
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Detroit | Michigan | United States | -83.04575 | 42.33143
Flint |... | 0 | NCT00445978 |
[
4
] | 250 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension. | null | Hypertension | children pediatrics high blood pressure hypertension valsartan enalapril | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
1,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. intervention 2: Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately th... | intervention 1: Valsartan intervention 2: Enalapril intervention 3: placebo matched to enalapril intervention 4: placebo matched to valsartan | 9 | East Hanover | New Jersey | United States | -74.36487 | 40.8201
Belgium | N/A | Belgium | N/A | N/A
France | N/A | France | -0.84802 | 45.60366
Germany | N/A | Germany | N/A | N/A
Hungary | N/A | Hungary | N/A | N/A
India | N/A | India | 75.36261 | 23.01533
Italy | N/A | Italy | N/A | N/A
Poland | N/A | Poland | N/A | ... | 0 | NCT00446511 |
[
4
] | 505 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is determine whether the combination of naltrexone SR and bupropion SR is safe and effective in treating obesity in subjects with type 2 diabetes. | Optimal care of patients with diabetes mellitus includes vigorous and persistent efforts to achieve physiologic control of blood glucose as well as other often associated conditions including hypertension, dyslipidemia and excess weight. Pharmacologic interventions for the treatment of obesity in type 2 diabetes have s... | Obesity Overweight Diabetes Mellitus, Type 2 | Obesity Overweight Diabetes Mellitus, Type 2 | null | 2 | arm 1: Naltrexone SR 32 mg/bupropion SR 360 mg/ day with ancillary therapy arm 2: Placebo with ancillary therapy | [
0,
2
] | 3 | [
0,
0,
5
] | intervention 1: None intervention 2: None intervention 3: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling | intervention 1: Naltrexone SR 32 mg/bupropion SR 360 mg/ day intervention 2: Placebo intervention 3: Ancillary therapy | 53 | Fairhope | Alabama | United States | -87.90333 | 30.52297
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Beverly Hills | California | United States | -118.40036 | 34.07362
Carmichael | Califor... | 0 | NCT00474630 |
[
3
] | 54 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Hypotheses:
1. Primary null hypothesis: The rate of clinical response, assessed as patient-reported global symptom rating and "adequate relief of IBS symptoms," does not differ between non-depressed IBS patients treated with the SSRI citalopram and patients treated with placebo.
2. Secondary null hypotheses:
1. Ch... | Irritable bowel syndrome (IBS) affects an estimated 15 million Americans at a cost of $1.7 billion per year. Visceral hypersensitivity is present in many patients with IBS, but its contribution to clinical symptoms is unclear. Tricyclic antidepressants may be beneficial in IBS, but their side effects can be unacceptabl... | Irritable Bowel Syndrome | Irritable bowel syndrome Antidepressant IBS Serotonin-reuptake inhibitor SSRI Visceral sensitivity Barostat Quality of life Depression | null | 2 | arm 1: One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks arm 2: Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 20mg/day for 4 weeks, then 40 mg/day for 4 weeks intervention 2: Identical to citalopram 20mg capsules; 1 capsule/day for 4 weeks, then 2 capsules/day for 4 weeks | intervention 1: Citalopram intervention 2: Placebo | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00477165 |
[
3
] | 103 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | true | 0ALL | true | The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects processes related to the development of Alzheimer's disease, including: 1) levels of a substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood flow in the brain, 3) inflammation in the brain, and... | Some studies suggest that statin medications, which are a group of cholesterol-lowering medicines, may help prevent Alzheimer's disease. However, this has not been proven in humans. The purpose of this study is to see how simvastatin affects a substance in the spinal fluid around the brain called beta-amyloid-42 which ... | Alzheimer Disease | amyloid protein apolipoprotein cerebrospinal fluid cerebrovascular circulation inflammation magnetic resonance imaging prevention & control | null | 2 | arm 1: simvastatin 40 mg nightly for 1 month then 80 mg nightly for 8 months arm 2: Matching placebo tablet nightly for 9 months | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 40 mg tablet each night for one month, then 80 mg for 8 months intervention 2: Matching tablet each night for 9 months | intervention 1: Simvastatin intervention 2: Placebo | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00486044 |
[
4
] | 1,166 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503) extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients with moderate to severe chronic pain over a period of 1 year. The study will also assess dosage requirements over the long term; characte... | All patients who complete the Phase 3 pivotal trials in osteoarthritis (R331333-PAI-3008; KF5503/11) and low back pain (R331333-PAI-3011; KF5503/23) and the Phase 3 safety trial in the non-European sites (R331333-PAI-3007; KF5503/24) will be allowed to continue participation in the program by entering this trial. The t... | Pain Osteoarthritis Low Back Pain | CG5503 Tapentadol chronic non-malignant pain osteoarthritis lower back pain analgesic opioid | null | 1 | arm 1: Tapentadol (CG5503) Extended Release (ER) 100 150 200 250 mg oral tablet twice daily for 52 weeks | [
0
] | 1 | [
0
] | intervention 1: 100, 150, 200, 250 mg oral tablet twice daily for 52 weeks | intervention 1: Tapentadol (CG5503) Extended Release (ER) | 148 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Hoover | Alabama | United States | -86.81138 | 33.40539
Mobile | Alabama | United States | -88.04305 | 30.69436
Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United States | -... | 0 | NCT00487435 |
[
0
] | 25 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | false | The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels. | Aneurysmal Subarachnoid hemorrhage or SAH (bleeding on the surface of the brain) affects 10 per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing of the blood vessels (vasospasm) and related delayed strokes are the most common serious complication. Narrowing of blood vessels affec... | Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm | SAH Vasospasm | null | 3 | arm 1: Placebo tablet arm 2: Simvastatin 40 mg arm 3: Simvastatin 80 mg | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Comparing two doses of Simvastatin to placebo intervention 2: Placebo tablet intervention 3: Comparing two doses of Simvastatin to placebo | intervention 1: Simvastatin 40 mg intervention 2: Placebo intervention 3: Simvastatin 80 mg | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00487461 |
[
3
] | 118 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of interferon-β \[IFN-β\].
Secondary objectives were:
* to estimate the effects ... | The study period per participant was approximatively 44 weeks broken down as follows:
* Screening period up to 4 weeks,
* 24-week double-blind treatment period\*,
* 16-week post-treatment elimination follow-up period.
'\*' participants successfully completing the week 24 visit were offered the opportunity to enter th... | Multiple Sclerosis | MS interferon-beta adjunctive therapy relapses | null | 3 | arm 1: Teriflunomide 7 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks arm 2: Teriflunomide 14 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks arm 3: Placebo (for Teriflunomide) once daily concomitantly with Interferon-β (IFN-β) for 24 weeks | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Film-coated tablet
Oral administration intervention 2: Film-coated tablet
Oral administration intervention 3: Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection | intervention 1: Teriflunomide intervention 2: Placebo (for Teriflunomide) intervention 3: Interferon-β | 5 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Laval | N/A | Canada | -73.692 | 45.56995
Berlin | N/A | Germany | 13.41053 | 52.52437
Milan | N/A | Italy | 9.18951 | 45.46427
Barcelona | N/A | Spain | 2.15899 | 41.38879 | 0 | NCT00489489 |
[
4
] | 1,461 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study f... | null | Alzheimer's Disease | cognition Alzheimer's disease Rosiglitazone extended-release (XR) safety adjunctive therapy BRL-049653 tolerability open-label extension | null | 1 | arm 1: Investigational drug | [
0
] | 1 | [
0
] | intervention 1: Experimental drug | intervention 1: Rosiglitazone XR | 272 | Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fresno | California | United States | -119.77237 | 36.74773
Rancho Mirage | C... | 0 | NCT00490568 |
[
5
] | 69 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction induced by environmental cat dander exposure in patients 18-65 years old with stable, mode... | A cat dander allergen challenge model was used to collect data for all of the Outcome Measures. The cat allergen levels in the model are similar to those found in homes with cats and are capable of inducing lower- and upper-airway responses that have been used to assess the efficacy of several asthma and allergy therap... | Asthma | Xolair Allergic asthma Cat allergy | null | 2 | arm 1: Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. arm 2: Patients received pla... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection. intervention 2: Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab. | intervention 1: Omalizumab intervention 2: Placebo | 0 | null | 0 | NCT00495612 |
[
3
] | 47 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well sirolimus works in treating patients with advanced pancreatic cancer. | OBJECTIVES:
Primary
* To determine the proportion of patients with previously treated advanced pancreatic cancer surviving at 6 months after treatment with single agent rapamycin.
* To evaluate the relationship between activation of the PI3/Akt/mTOR/S6K signaling pathway in tumor tissues and rapamycin activity in thi... | Pancreatic Cancer | recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas | null | 1 | arm 1: Sirolimus 5mg. po QD continously (28 days=cycle) | [
0
] | 1 | [
0
] | intervention 1: Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days. | intervention 1: sirolimus | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00499486 |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors. | Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.0; Continue until progressive disease/unacceptable toxicity;Evaluate q 8 weeks. | Neuroendocrine Tumors | low-grade neuroendocrine tumors lithium | null | 1 | arm 1: Lithium carbonate will be dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate will be provided as a 300mg tablet and will be taken daily without breaks in treatment. | [
0
] | 1 | [
0
] | intervention 1: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate will be administered the first week at 300 mg flat dose three times each day. A serum lithium level will be checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluate every ... | intervention 1: Lithium Carbonate | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00501540 |
[
3
] | 67 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a multi-centre, phase II study to assess the efficacy and safety of ZD6474 in patients with Child-Pugh class A, inoperable HCC. This study comprises 2 phases, the primary treatment phase and the secondary treatment phase. The primary treatment phase is a randomised, double-blind, parallel-group phase II study t... | null | Carcinoma, Hepatocellular | Hepatocellular carcinoma Advanced solid, malignant tumour | null | 3 | arm 1: Best Supportive Care + Placebo arm 2: Best Supportive Care + ZD6474 100 mg arm 3: Best Supportive Care + ZD6474 300 mg | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: ZD6474 300mg intervention 2: ZD6474 100 mg intervention 3: Placebo + Best Supportive Care | intervention 1: Vandetanib intervention 2: Vandetanib intervention 3: Best Supportive Care | 3 | Tainan City | N/A | Taiwan | 120.21333 | 22.99083
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896 | 0 | NCT00508001 |
[
4
] | 622 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults. | Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults. | Bacterial Pneumonia | ceftaroline Community-acquired pneumonia CAP Streptococcus pneumoniae Haemophilus influenzae Mycoplasma pneumoniae Chlamydophila spp Legionella ssp multi-drug resistant Streptococcus pneumoniae (MDRSP) antimicrobial resistance pneumococci beta-lactam ceftaroline fosamil ceftriaxone antibiotic | null | 2 | arm 1: Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h). arm 2: Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days intervention 2: 1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days intervention 3: Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 m... | intervention 1: Ceftaroline fosamil for Injection intervention 2: Ceftriaxone intervention 3: Placebo | 134 | Durham | North Carolina | United States | -78.89862 | 35.99403
Autonoma | Buenos Aires | Argentina | N/A | N/A
Mar del Plata | Buenos Aires | Argentina | -57.5562 | -38.00042
Merlo | Buenos Aires | Argentina | -58.72744 | -34.66536
Córdoba | Córdoba Province | Argentina | -64.18853 | -31.40648
Buenos Aires | N/A | Arge... | 0 | NCT00509106 |
[
3
] | 112 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). | null | Metastatic Breast Cancer | Trastuzumab emtansine MBC Breast cancer HER2-positive breast cancer HER2 | null | 1 | arm 1: Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle. | [
0
] | 1 | [
0
] | intervention 1: Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation. | intervention 1: Trastuzumab emtansine [Kadcyla] | 40 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Denver | Colorado | United States | -104.9847 | 39.73915
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Boca Raton | Florida | United States | -80.0831 | 26.35869
Davie | Florida | United States | -80.2331 | 26.06287
Jacksonvil... | 0 | NCT00509769 |
[
4
] | 110 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 1FEMALE | false | The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD). | null | Contraception | null | 2 | arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic COC arm 2: Levonorgestrel (LNG) and Ethinyl Estradiol (EE), 0.150 mg LNG and 0.030 mg EE monophasic COC | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years). intervention 2: Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethiny... | intervention 1: NOMAC-E2 intervention 2: LNG-EE | 0 | null | 0 | NCT00511342 | |
[
3,
4
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | Chronic insomnia is a major public health problem that affects about 10% of adults and is associated with serious and distressful health consequences such as depression, anxiety and reduced quality of life. Sleep medications are effective, but side effects, costs and uncertain long term efficacy call for non-pharmacolo... | The NIH's 2003 National Sleep Disorders Research Plan defines insomnia as "difficulty falling asleep, difficulty staying asleep or short sleep duration, despite adequate opportunity for sleep," and estimates that it affects 30% to 40% of adults. The prevalence of chronic insomnia, defined as sleep disturbances for 4 we... | Chronic Insomnia Primary Insomnia | mindfulness meditation MBSR mindfulness meditation sleep insomnia chronic insomnia primary insomnia Minnesota | null | 2 | arm 1: A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring. arm 2: A pharmacotherapy control arm (PCT Sleeping Pills) consisting of a state-of-the-art prescription sedative hypnotic, eszopiclone - br... | [
0,
1
] | 2 | [
5,
0
] | intervention 1: The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes home... | intervention 1: Mindfulness-Based Stress Reduction intervention 2: eszopiclone | 2 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00515177 |
[
3
] | 43 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | true | This study is to determine the effects of Lovaza in platelet function studies | Cardiovascular disease remains a leading cause of death in North America (1). Uncontrolled platelet activation, adhesion and aggregation initiated by vessel wall plaque rupture are thought to be responsible for acute vascular occlusion in many situations (2-5). Although many platelet inhibition drugs are available, all... | Cardiovascular Disease Bleeding | Platelet Cardiovascular Lipid Fish Oil Omega 3 DHA EPA Bleeding Clotting platelet function Lipid profile Weight and Bleeding risk | null | 4 | arm 1: Patient is not on Aspirin, Clopidogrel, or Warfarin and is taking escalating doses of study drug. arm 2: Patient is on regular dose of Aspirin ( \< or = 325mg). Patient is not taking Clopidogrel or Warfarin and is taking the escalating doses of Lovaza arm 3: Patient is taking regularly 75mg of clopidogrel daily ... | [
1,
1,
1,
1
] | 1 | [
0
] | intervention 1: First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily | intervention 1: Lovaza | 0 | null | 0 | NCT00515541 |
[
3
] | 15 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Objectives:
Primary: To evaluate the response rate of total cytokine-immunotherapy for low-risk myelodysplastic syndromes (MDS).
Secondary: To evaluate response duration, survival and side effects of the treatment. | MDS is a disease that produces low blood counts and may cause anemia, infections, and/or bleeding. Erythropoietin and Granulocyte colony-stimulating factor (G-CSF or GCSF) are drugs that stimulate the production of red cells and white cells. Prednisone and cyclosporin are drugs that work against MDS by affecting your i... | Myelodysplastic Syndrome | Myelodysplastic Syndrome MDS Erythropoietin Darbepoetin alfa Aranesp Erythropoiesis stimulating protein G-CSF Filgrastim Neupogen Prednisone Cyclosporin A Sandimmune CYA Cyclosporine | null | 1 | arm 1: Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice a week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 40,000 units injected under the skin (SQ) weekly intervention 2: 300 mg (tablets) by mouth daily for 6 months intervention 3: 300 mcg injected under the skin (SQ) two times per week intervention 4: 60 mg per day for 7 days, taper over 1 month | intervention 1: Erythropoietin intervention 2: Cyclosporin A intervention 3: G-CSF intervention 4: Prednisone | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00520468 |
[
3
] | 4 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well to the study drug, and the response of symptoms to the study drug will also be determined. | DepoCyt is a sustained-release formulation of the chemotherapy drug, cytarabine (Ara-C), which is used for the treatment of patients with lymphomatous or leukemic meningitis, a complication of lymphoma/leukemia that is characterized by the spread of cancer to the central nervous system.
DepoCyt is introduced into the ... | Neoplastic Meningitis Lymphoma, B Cell | Lymphoma Leukemia Leukemic Meningitis Lymphomatous Meningitis | null | 2 | arm 1: Subjects with Lymphomatous Meningitis arm 2: Subjects with Leukemic Meningitis | [
0,
0
] | 1 | [
0
] | intervention 1: 50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses | intervention 1: cytarabine liposome injection | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00523939 |
[
4
] | 368 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of the study was to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In addition, the effect of treatment on quality of life and general health status was evaluated. | null | Constipation | null | 2 | arm 1: patient to receive two enteric-coated tablets containing 5 mg bisacodyl arm 2: patient to receive two placebo-to-match enteric-coated tablets 5 mg bisacodyl | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 2 x 5 mg bisacodyl once daily intervention 2: Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily | intervention 1: Bisacodyl 10 mg intervention 2: Placebo | 27 | Addlestone | N/A | United Kingdom | -0.49353 | 51.37135
Ash Vale, Aldershot | N/A | United Kingdom | N/A | N/A
Ashford | N/A | United Kingdom | 0.87376 | 51.14648
Atherstone | N/A | United Kingdom | -1.54693 | 52.57536
Bedworth | N/A | United Kingdom | -1.46909 | 52.4791
Bennetthorpe, Doncaster | N/A | United Kingdom |... | 0 | NCT00526097 | |
[
3
] | 222 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | false | The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis. | This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis. | Osteoporosis | osteoporosis postmenopausal bone loss | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
2,
0,
0,
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: teriparatide 20 µg subcutaneous daily intervention 2: Placebo subcutaneous daily intervention 3: BA058 20 µg subcutaneous daily intervention 4: BA058 40 µg subcutaneous daily intervention 5: BA058 80 µg subcutaneous daily | intervention 1: teriparatide intervention 2: Placebo intervention 3: BA058 20 µg intervention 4: BA058 40 µg intervention 5: BA058 80 µg | 1 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751 | 0 | NCT00542425 |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon, CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily) plus prednisone. After 3 months, if patients h... | null | Myelodysplastic Syndromes | null | 1 | arm 1: Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 1 gm twice daily orally until end of study. intervention 2: 10 mg/day orally until end of study. intervention 3: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks. | intervention 1: Mycophenolate mofetil intervention 2: Prednisone intervention 3: Erythropoietin Beta | 8 | Barakaldo | N/A | Spain | -2.98813 | 43.29639
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Cadiz | N/A | Spain | -6.2891 | 36.52672
Madrid | N/A | Spain | -3.70256 | 40.4165
Palma de Ma... | 0 | NCT00551291 | |
[
5
] | 340 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room... | null | Pain | Renal Colic Pain Urinary Tract Colic | null | 2 | arm 1: Ketoprofen plus placebo parecoxib arm 2: Parecoxib plus placebo ketoprofen | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection intervention 2: Parecoxib 40 mg diluted in 2 ml of nor... | intervention 1: Ketoprofen 100mg intervention 2: Parecoxib 40mg | 17 | Rio de Janeiro | Rio de Janeiro | Brazil | -43.18223 | -22.90642
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
Ribeirão Preto | São Paulo | Brazil | -47.81028 | -21.1775
Ribeirão Preto | São Paulo | Brazil | -47.81028 | -21.1775
São B... | 0 | NCT00553605 |
[
4
] | 2,487 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions. | null | Obesity Type 2 Diabetes | Obesity, Type 2 diabetes | null | 3 | arm 1: high dose experimental treatment arm 2: mid dose experimental treatment arm 3: Placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: phentermine 15 mg and topiramate 92 mg, po once daily intervention 2: phentermine 7.5 mg and topiramate 46 mg, po once daily intervention 3: placebo | intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: VI-0521 | 6 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Ridgefield | Connecticut | United States | -73.49818 | 41.28148
New York | New York | United States | -74.00597 | 40.71427
Durham | North Carolina | United States | -78.89862 | 35.99403
Toledo | Ohio | United States | -83.55521 | 41.66394
Austin | Texas | Unit... | 0 | NCT00553787 |
[
3
] | 63 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the Yale Global Tic Severi... | null | Tourette Syndrome | null | 2 | arm 1: None arm 2: None | [
5,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: pramipexole immediate release (IR) intervention 2: Placebo | 16 | Bradenton | Florida | United States | -82.57482 | 27.49893
Tampa | Florida | United States | -82.45843 | 27.94752
Columbus | Georgia | United States | -84.98771 | 32.46098
Chicago | Illinois | United States | -87.65005 | 41.85003
Cambridge | Massachusetts | United States | -71.10561 | 42.3751
Manhasset | New York | Uni... | 0 | NCT00558467 | |
[
2,
3
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF) and chronic infection due to pseudomonas aeruginosa. | CF is a gentic disease resulting from mutations in a 230 kb gene on chromosome 7 known as the cystic fibrosis transmembrane conductance regulator (CFTR). Study subjects with CF manifest pathological changes in a variety or organs that express CFTR. The lungs are frequently affected, the sequelae being chronic infection... | Cystic Fibrosis | Cystic Fibrosis Respiratory Infections Pulmonary Cystic Fibrosis CFTR | null | 5 | arm 1: Arikayce™ at 560 mg Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo. arm 2: Matching placebo for 560 mg Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo. arm 3: Arikayce™ at 70 mg Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo. arm 4: Arikayce™ at 140 m... | [
1,
2,
1,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Arikayce™ at 560 mg
Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 2:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study ... | intervention 1: Arikayce™ 560 mg intervention 2: Placebo for 560 mg intervention 3: Arikayce™ 70 mg intervention 4: Arikayce™ 140 mg intervention 5: Placebo for 70 mg / 140 mg | 19 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Iowa City | Iowa | Un... | 0 | NCT00558844 |
[
0
] | 60 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | true | To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to patients with early and moderate Atrophic Age Related Macular Degeneration. | To evaluate whether or not zeaxanthin supplementation raises macular pigment optical density (MPOD). Previous research has shown MPOD to mirror visual benefits for patients with age related atrophic macular degeneration (AMD) having visual symptoms (decreased visual acuity, contrast sensitivity, photostress glare recov... | Age Related Macular Degeneration Cognition Disorders | Macular Pigment Optical Density Skin Carotenoids Lipofuscin Photostress (Glare Recovery) Visual Field Progression Contrast Sensitivity Color Vision Cognitive Function | null | 3 | arm 1: 9 mg of Lutein for 12 months arm 2: 3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months arm 3: 3R 3'R Zeaxanthin 8 mg per day during 12 months | [
2,
1,
1
] | 3 | [
0,
7,
7
] | intervention 1: 8 mg per day during 12 months intervention 2: 9 mg of Lutein during 12 months intervention 3: 8 mg of lutein and 8 mg of Zeaxanthin administered during 12 months | intervention 1: 3R 3'R Zeaxanthin intervention 2: Lutein intervention 3: Lutein and Zeaxanthin | 1 | North Chicago | Illinois | United States | -87.84118 | 42.32558 | 0 | NCT00564902 |
[
4
] | 1,496 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine whether the combination of naltrexone SR and bupropion SR is safe and effective in the treatment of obesity. | Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than naltrexone alone, bupropion SR alone or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of the combination of naltrexone SR and b... | Obesity Overweight | Obesity | null | 2 | arm 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day with ancillary therapy arm 2: Placebo with ancillary therapy | [
0,
2
] | 3 | [
0,
0,
5
] | intervention 1: None intervention 2: None intervention 3: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling | intervention 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day intervention 2: Placebo intervention 3: Ancillary therapy | 36 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Carmichael | California | United States | -121.32828 | 38.61713
Fresno | California | United States | -119.77237 | 36.74773
Newport Beach | Cal... | 0 | NCT00567255 |
[
3
] | 23 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of eac... | null | Breast Cancer | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 15mg/kg iv on day 1 of each 3 week cycle intervention 2: 75mg/m2 iv on day 1 of each 3 week cycle intervention 3: 2000mg/m2 po on days 1-15 of each 3 week cycle | intervention 1: bevacizumab [Avastin] intervention 2: Docetaxel intervention 3: Xeloda | 1 | Madrid | Madrid | Spain | -3.70256 | 40.4165 | 0 | NCT00576901 | |
[
5
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma.
Hypotheses:
1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in imp... | null | Pancreatic Cancer | null | 2 | arm 1: subject randomized to 10ml of dehydrated alcohol arm 2: subject randomized to 20ml of dehydrated alcohol | [
5,
0
] | 1 | [
0
] | intervention 1: subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure | intervention 1: dehydrated alcohol | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 0 | NCT00578279 | |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX). | null | Langerhans Cell Histiocytosis | Langerhans Cell Histiocytosis LCH 6-Thioguanine 6-TG Methotrexate MTX 94-132 | null | 1 | arm 1: MTX, 6-TG, Leucovorin | [
0
] | 3 | [
0,
0,
0
] | intervention 1: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs intervention 2: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose. intervention 3: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 dos... | intervention 1: Methotrexate intervention 2: 6-Thioguanine intervention 3: Leucovorin Calcium | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00588536 |
[
4
] | 1,221 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia. | This is a randomized (patients assigned to treatment groups by chance), double-blind (patient and study staff will not know the treatment assignment) study of paliperidone palmitate compared with RISPERDAL CONSTA (Risperidone Long-Acting Intramuscular Injection) in adult patients with schizophrenia. The total duration ... | Schizophrenia | Schizophrenia long-acting injectable antipsychotic medication | null | 2 | arm 1: RISPERDAL CONSTA 25-50 mg eq every 2 weeks arm 2: Paliperidone Palmitate 50-150 mg eq every 4 wks | [
1,
0
] | 2 | [
0,
0
] | intervention 1: RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscula... | intervention 1: RISPERDAL CONSTA intervention 2: Paliperidone palmitate | 82 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Cerritos | California | United States | -118.06479 | 33.85835
Garden Grove | California | United States | -117.94145 | 33.77391
Los Angeles | California | United States | -118.24368 | 34.05223
Washi... | 0 | NCT00589914 |
[
3
] | 45 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy. | null | Epilepsy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 1 | [
0
] | intervention 1: 1 Dose | intervention 1: Clonazepam | 6 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Bethesda | Maryland | United States | -77.10026 | 38.98067
New York | New York | United States | -74.00597 | 40.71427
Columbus | Ohio | United States | -82.99879 | 39.96118
Dallas | Texas | United States | -96.80667 | 32.78306
Tampere | N/A | Finland | 23.78... | 0 | NCT00594945 | |
[
3
] | 36 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer. | The following rationale can be made for a Phase II trial to evaluate sunitinib malate (Sutent) for the therapy of progressive metastatic androgen-independent prostate cancer (AIPC) following prior docetaxel chemotherapy. Since most patients with metastatic AIPC following prior chemotherapy clinically progress rapidly, ... | Metastatic Prostate Cancer | null | 1 | arm 1: Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles) | [
0
] | 1 | [
0
] | intervention 1: 50 mg/day orally each of Days 1-28 of each 6 week cycle | intervention 1: Sunitinib | 45 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Torrington | Connecticut | United States | -73.12122 | 41.80065
Ocala | Florida | United States | -82.14009 | 29.1872
Niles | Illinois | United States | -87.80284 | 42.01892
Terre Haute | Indiana | United States | -87.41391 | 39.4667
Columbia | Maryland | United... | 0 | NCT00599313 | |
[
3
] | 111 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study was to evaluate the safety and effectiveness of an investigational drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis, in comparison with a placebo ("sugar pill"). All study related care was provided including doctor visits, physical exams, laboratory ... | This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study to evaluate the efficacy and safety of doxercalciferol given orally, once daily for 24 weeks to participants with moderate to severe chronic plaque psoriasis. Participants were randomized and stratified by site and ... | Moderate to Severe Chronic Plaque Psoriasis | psoriasis psoriasis vulgaris plaque psoriasis chronic plaque psoriasis | null | 4 | arm 1: Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24. arm 2: Doxercalciferol 5 mcg capsules orally once daily up to Week 24. arm 3: Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24. arm 4: Placebo matching to doxercalciferol capsules orally once daily up to Week 24. | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Doxercalciferol intervention 2: Placebo | 19 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Hot Springs | Arizona | United States | N/A | N/A
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Irvine | California | United States | -117.82311 | 33.66946
Santa Monica | California | United States | -118.49138 | 34.01949
Alpharetta | Georgia |... | 0 | NCT00601107 |
[
3
] | 89 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as perillyl alcohol, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. It is not yet known which dose of topical perillyl alcohol is more effective in stopping the development of cancer in sun damaged s... | OBJECTIVES:
Primary
* To determine if topical administration of perillyl alcohol (POH) cream can reverse actinic damage as evidenced by normalization of quantitative skin histopathology scores in skin tissue biopsy samples from patients with moderate to severe sun damage.
Secondary
* To determine if topical POH can... | Precancerous Condition | actinic keratosis | null | 3 | arm 1: Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity. arm 2: Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity. arm 3: Patients apply peri... | [
2,
0,
0
] | 2 | [
0,
10
] | intervention 1: Applied as topical cream intervention 2: Applied as topical cream | intervention 1: perillyl alcohol intervention 2: placebo | 1 | Tucson | Arizona | United States | -110.92648 | 32.22174 | 0 | NCT00608634 |
[
3
] | 137 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery | null | Dry Eye Syndromes | LASIK | null | 2 | arm 1: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) arm 2: Artificial Tears (REFRESH ENDURA®) | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery intervention 2: REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery | intervention 1: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) intervention 2: Artificial Tears REFRESH ENDURA® | 1 | Overland Park | Kansas | United States | -94.67079 | 38.98223 | 0 | NCT00611403 |
[
3,
4
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 1FEMALE | false | The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize t... | null | Pain Surgical Abortion | Pain associated with first trimester surgical abortion | null | 2 | arm 1: Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion arm 2: Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion | [
1,
0
] | 2 | [
0,
0
] | intervention 1: paracervical block with lidocaine intervention 2: paracervical block with ketorolac and lidocaine | intervention 1: lidocaine intervention 2: ketorolac and lidocaine | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00617097 |
[
4
] | 606 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia | The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries | Bacterial Pneumonia | ceftaroline Community-acquired pneumonia CAP IV (intravenous) Streptococcus pneumoniae Haemophilus influenzae Mycoplasma pneumoniae Chlamydophila spp Legionella spp Multi-drug resistant Streptococcus pneumoniae (MDRSP) antimicrobial resistance pneumococci Ceftriaxone bacteria ß-lactam beta-lactam antibiotic | null | 2 | arm 1: Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h).
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulato... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days intervention 2: 1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days intervention 3: Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30... | intervention 1: Ceftaroline fosamil for Injection intervention 2: IV Ceftriaxone intervention 3: Placebo intervention 4: Clarithromycin | 168 | Los Angeles | California | United States | -118.24368 | 34.05223
Pasadena | California | United States | -118.14452 | 34.14778
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Orlando | Florida | United States | -81.37924 | 28.53834
Fort Gordo... | 0 | NCT00621504 |
[
3
] | 5 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine if dexamethasone given at night is a more effective treatment for congenital adrenal hyperplasia in young children than standard three times per day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more efficient suppression of the hypothalamic-pituit... | This is a Phase II clinical trial, intended to estimate the effect of instituting Dexamethasone therapy in comparison to prior standard therapy. Each subject provides his own baseline data. There is no control group. Patients with CAH who meet inclusion criteria will be admitted to the clinical research center for two ... | Adrenal Hyperplasia, Congenital | null | 1 | arm 1: Experimental therapy with nocturnal dexamethasone. | [
0
] | 2 | [
0,
0
] | intervention 1: Dexamethasone will be given at a dose that equals 1/50 of the total daily hydrocortisone dose of the patient. It will be given in solution form at 10 PM for 3 days. intervention 2: Subjects were given their baseline hydrocortisone regimen which was three times daily for 4 of the subjects and twice daily... | intervention 1: dexamethasone intervention 2: Hydrocortisone | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00621985 | |
[
4
] | 838 | null | null | 0TREATMENT | null | false | 0ALL | null | The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.
An additional objective is to assess the efficacy and safety of concomita... | null | Hypertension | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: fixed-dose combination of telmisartan 40mg+amlodipine 10mg intervention 2: fixed-dose combination of telmisartan 80mg+amlodipine10mg | 92 | Gosford | New South Wales | Australia | 151.34399 | -33.4244
Liverpool | New South Wales | Australia | 150.92588 | -33.91938
Kippa-Ring | Queensland | Australia | 153.0835 | -27.22586
Milton | Queensland | Australia | 153.00312 | -27.47039
Elizabeth Vale | South Australia | Australia | 138.66819 | -34.74857
Eggenburg |... | 0 | NCT00624052 | |
[
3
] | 773 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of a... | null | Impetigo Secondarily Infected Traumatic Lesions | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: BID 7 days intervention 2: TID 7 days intervention 3: BID 7 days | intervention 1: TD1414 2% cream intervention 2: TD1414 2% cream intervention 3: Bactroban® (mupirocin) 2% cream | 2 | Anniston | Alabama | United States | -85.83163 | 33.65983
Cape Town | Western Cape | South Africa | 18.42322 | -33.92584 | 0 | NCT00626795 | |
[
4
] | 343 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain | null | Chronic Pain | OA Chronic Pain Osteoarthritis OA Pain Osteoarthritis Pain Pain Hip Pain Knee Pain Joint Pain | null | 2 | arm 1: OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg arm 2: Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets intervention 2: Placebo | intervention 1: OROS hydromorphone intervention 2: Placebo | 0 | null | 0 | NCT00631319 |
[
2
] | 23 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21 days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and safety of this dosing schedule in participants with advanced cancer | null | Advanced Solid Tumors | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Capsules, Oral, Dose escalating (Phase 1), 3 doses on 1 day every 3 weeks, until disease progression or unacceptable toxicity | intervention 1: Ixabepilone (oral formulation) | 2 | Stanford | California | United States | -122.16608 | 37.42411
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 | 0 | NCT00632424 | |
[
3
] | 93 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate (MF) dry powder inhaler (DPI) and MDI formulations in adul... | This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate MDI formulation and medium dose mometasone furoate (MF) DPI and MDI formulations in adults and adolescents with persistent allergic asthma.... | Asthma Airway Inflammation | mometasone formoterol | null | 6 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None | [
0,
0,
0,
0,
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days intervention 2: mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days intervention 3: mometasone ... | intervention 1: mometasone furoate/formoterol 100/10 mcg intervention 2: mometasone furoate/formoterol 200/10 mcg intervention 3: mometasone furoate/formoterol 400/10 mcg intervention 4: MF DPI 200 mcg intervention 5: MF MDI 200 mcg intervention 6: Placebo | 0 | null | 0 | NCT00635882 |
[
4
] | 389 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control. | null | Diabetes Mellitus, Type 2 | null | 2 | arm 1: BI 1356 5mg in initial combination therapy with pioglitazone 30 mg arm 2: Placebo in initial combination therapy with pioglitazone 30 mg | [
0,
2
] | 2 | [
0,
0
] | intervention 1: placebo + overcapsulated 30 mg tablet, once daily intervention 2: 5 mg tablet + overcapsulated 30 mg tablet, once daily | intervention 1: placebo + pioglitazone (30 mg) intervention 2: Linagliptin + pioglitazone (30 mg) | 43 | Feldkirch | N/A | Austria | 9.6 | 47.23306
Graz | N/A | Austria | 15.45 | 47.06667
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Athens | N/A | Greece | 23.72784 | 37.98376
Athens | N/A | Greece | 23.72784 | 37.98376
Ioannina | N/A | Greece | 20.85189 | 39.66486
Melissia-Athe... | 0 | NCT00641043 | |
[
5
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine. | null | Alzheimer's Disease | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: memantine tablets, twice a day (bid), for 20 weeks | intervention 1: Memantine | 1 | Krefeld | North Rhine-Westphalia | Germany | 6.55381 | 51.33645 | 0 | NCT00649220 | |
[
4
] | 151 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. | null | Hypercholesterolemia | null | 1 | arm 1: Ezetimibe 10 mg + Simvastatin 20 mg | [
0
] | 2 | [
0,
0
] | intervention 1: Ezetimibe 10 mg once daily intervention 2: Simvastatin 20 mg daily | intervention 1: Ezetimibe intervention 2: Simvastatin | 0 | null | 0 | NCT00653523 | |
[
4
] | 146 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors. | null | Hypercholesterolemia | null | 1 | arm 1: Ezetimibe 10 mg + Atorvastatin 20 mg | [
0
] | 2 | [
0,
0
] | intervention 1: Ezetimibe 10 mg once daily intervention 2: atorvastatin 20 mg once daily | intervention 1: Ezetimibe intervention 2: atorvastatin | 0 | null | 0 | NCT00654095 | |
[
4
] | 306 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS) | null | Restless Legs Syndrome | null | 2 | arm 1: 4 weeks of individual dose titration starting with Pramipexole 0.125 mg, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily arm 2: 4 weeks of individual dose titration as for the investigational product, once daily | [
5,
5
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Pramipexole intervention 2: Placebo | 16 | Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Guangzhou | N/A | China | 113.25 | 23.11667
Haerbin | N/A | China | N/A | N/A
Hangzhou | N/A | China... | 0 | NCT00654498 | |
[
5
] | 207 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects. | This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met. | Type 2 Diabetes Hypertension | blood pressure reduction | null | 1 | arm 1: amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Amlodipine 5 mg tablets , Daily for 3 weeks; intervention 2: amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg intervention 3: hydrochlorothiazide tablets, 12.5 mg or 25 mg. | intervention 1: Amlodipine intervention 2: amlodipine / olmesartan medoxomil combination intervention 3: Hydrochlorothiazide | 21 | Los Angeles | California | United States | -118.24368 | 34.05223
Sylmar | California | United States | -118.44925 | 34.30778
Tustin | California | United States | -117.82617 | 33.74585
Aventura | Florida | United States | -80.13921 | 25.95648
DeLand | Florida | United States | -81.30312 | 29.02832
Hialeah | Florida | U... | 0 | NCT00654745 |
[
3
] | 167 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection | null | Chronic Hepatitis C | null | 6 | arm 1: Daclatasvir (1 mg), once daily
or
Matching Placebo, once daily arm 2: Daclatasvir (10 mg), once daily
or
Matching Placebo, once daily arm 3: Daclatasvir (1-100 mg), once or twice daily
or
Matching Placebo, once or twice daily arm 4: Daclatasvir (1-100 mg), once or twice daily
or
Matching Placebo, once or... | [
1,
1,
1,
1,
1,
1
] | 2 | [
0,
0
] | intervention 1: Capsule, Oral, Approximately 182 days from initial dosing intervention 2: Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel | intervention 1: Daclatasvir intervention 2: Placebo | 8 | Anaheim | California | United States | -117.9145 | 33.83529
Cypress | California | United States | -118.03729 | 33.81696
New Haven | Connecticut | United States | -72.92816 | 41.30815
Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834
Baltimore | Maryland | U... | 0 | NCT00663208 | |
[
2
] | 16 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 2MALE | false | We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism. | This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (T), in normal men whose endogenous T production has been temporarily suppressed by the administration of the potent GnRH antagonist Acyline. We will be determining the relative pharmacokinetics of six differe... | Contraception Hypogonadism | Male Contraception Hypogonadism Testosterone | null | 2 | arm 1: (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 300 mcg/kg intervention 2: 24 hours after acyline administration on Day 2 "immediate release" Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, ... | intervention 1: Acyline intervention 2: Testosterone intervention 3: Finasteride | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00663793 |
[
5
] | 13 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in participants with moderate to severe secondary hyperparathyroidism (SHPT) undergoing hemodialysis who are resistant to treatment with calcitriol. | This is a multi-center, prospective, open label, one arm, phase IV study designed to demonstrate paricalcitol efficacy and safety in the treatment of moderate to severe secondary hyperparathyroidism in calcitriol resistant participants on dialysis.
Following screening, participants began an 8-week controlled calcitrio... | Secondary Hyperparathyroidism Dialysis | Dialysis Calcitriol Resistant Secondary Hyperparathyroidism | null | 1 | arm 1: Participants began a controlled calcitriol therapy period (calcitriol challenge) to confirm calcitriol resistance. After this period, those who failed to reduce PTH (according to parameters in protocol) initiated paricalcitol therapy. | [
5
] | 2 | [
0,
0
] | intervention 1: Initial doses determined according to the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) guideline (Am J Kidney Dis 2003;42(4)Suppl 3:S1-S201). During therapy, calcitriol dose may be modified by 0.5 - 1 mcg at 2- to 4-week intervals. intervention 2: Dose calculated by 0.... | intervention 1: Calcitriol intervention 2: Paricalcitol | 2 | São Paulo | N/A | Brazil | -46.63611 | -23.5475
São Paulo | N/A | Brazil | -46.63611 | -23.5475 | 0 | NCT00664430 |
[
3
] | 219 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy. | null | Rheumatoid Arthritis | null | 2 | arm 1: Fostamatinib disodium (R935788) 100 mg tablet, orally, twice-a-day arm 2: Placebo, orally, twice-a-day | [
0,
2
] | 2 | [
0,
0
] | intervention 1: R935788 100 mg tablet, orally, twice-a-day intervention 2: Placebo, orally, twice-a-day | intervention 1: Fostamatinib disodium (R935788) intervention 2: Placebo | 44 | Aventura | California | United States | N/A | N/A
Palm Desert | California | United States | -116.37697 | 33.72255
San Diego | California | United States | -117.16472 | 32.71571
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Boca Raton | Florida | United States | -80.0831 | 26.35869
Gains... | 0 | NCT00665626 | |
[
3
] | 457 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotre... | null | Rheumatoid Arthritis | null | 3 | arm 1: R788, 100 mg tablet, orally, twice-a-day arm 2: R788, 150 mg tablet, orally, once a day arm 3: Placebo, orally, either once a day, or twice a day | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 100 mg tablet, orally, twice-a-day intervention 2: 150 mg tablet, orally, once a day intervention 3: Placebo, orally, either once a day, or twice a day | intervention 1: Fostamatinib disodium (R935788) intervention 2: Fostamatinib disodium (R935788) intervention 3: Placebo | 65 | La Jolla | California | United States | -117.2742 | 32.84727
Palm Desert | California | United States | -116.37697 | 33.72255
Hamden | Connecticut | United States | -72.89677 | 41.39593
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Gainsville | Florida | United States | N/A | N/A
Ocala |... | 0 | NCT00665925 | |
[
0
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The University of North Carolina Department of Dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many flesh-colored bumps on the skin. It goes awa... | null | Molluscum Contagiosum, Skin Disease | null | 2 | arm 1: Subjects in this group will have topical application of cantharidin's vehicle at each visit. arm 2: Subjects in this group will have topical application of cantharidin at each visit. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Cantharidin's vehicle is composed of: Hydroxypropylcellulose, Acetone, and Collodion Flexible. The vehicle will be topically applied to molluscum lesions at each visit. Only two lesions will be treated at the first visit, and up to 20 lesions can be treated at subsequent visits. intervention 2: Subjects... | intervention 1: cantharidin's vehicle intervention 2: Cantharidin 0.7% | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00667225 | |
[
2,
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness. | null | Asthma | Asthma hyperresponsiveness | null | 1 | arm 1: Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated. | [
0
] | 1 | [
0
] | intervention 1: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in. | intervention 1: nadolol | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00670267 |
[
3
] | 151 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aeroso... | This trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the aerosol route to CF patients.
Study with completed results acquired from Horizon in 2024. | Cystic Fibrosis (CF) | null | 4 | arm 1: Placebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days arm 2: MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days arm 3: MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days arm 4: MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebu... | [
2,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: 3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days intervention 2: same frequency as study drug using the same nebulizer | intervention 1: MP-376 intervention 2: Placebo | 50 | Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | Californ... | 0 | NCT00677365 | |
[
3
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sora... | null | Carcinoma, Renal Cell | Renal Cell Cancer Interferon | null | 2 | arm 1: Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. arm 2: Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (tot... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously intervention 2: Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. | intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Sorafenib (Nexavar, BAY43-9006) + Interferon | 35 | Vienna | Vienna | Austria | 16.37208 | 48.20849
Salzburg | N/A | Austria | 13.04399 | 47.79941
Avignon | N/A | France | 4.80892 | 43.94834
Bayonne | N/A | France | -1.473 | 43.49316
Bordeaux | N/A | France | -0.5805 | 44.84044
Marseille | N/A | France | 5.38107 | 43.29695
Marseille | N/A | France | 5.38107 | 43.29695
N... | 0 | NCT00678288 |
[
3
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections | This study will assess the safety and efficacy of TG-873870 (Nemonoxacin) in patients with Diabetic Foot Infections. Pharmacokinetic (PK) and pharmacodynamic (PD) assessment will be conducted in a subgroup of eight consenting patients. | Diabetic Foot Infections | Diabetic Foot Infections, DFI, Nemonoxacin | null | 1 | arm 1: Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. | [
5
] | 1 | [
0
] | intervention 1: 750 mg | intervention 1: TG-873870 (Nemonoxacin) | 16 | Montebello | California | United States | -118.10535 | 34.00946
Pasadena | California | United States | -118.14452 | 34.14778
Des Moines | Iowa | United States | -93.60911 | 41.60054
East Lynne | Gauteng | South Africa | 28.27777 | -25.70664
Hammanskraal | Gauteng | South Africa | N/A | N/A
Pretoria | Gauteng | South A... | 0 | NCT00685698 |
[
5
] | 7 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in adolescents with ADHD and comorbid cannabis abuse. | In the past adolescents with cannabis abuse have been excluded from studies in which atomoxetine for ADHD symptoms was studied. In this study the efficacy of atomoxetine on symptoms of ADHD in adolescents with ADHD and comorbid cannabis abuse will be studied. | Attention Deficit Hyperactivity Disorder Cannabis Abuse | Attention Deficit Hyperactivity Disorder with Cannabis Abuse Marihuana Abuse Comorbid Cannabis Abuse | null | 1 | arm 1: 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules. | [
0
] | 1 | [
0
] | intervention 1: 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules. | intervention 1: Atomoxetine | 1 | The Hague | N/A | Netherlands | 4.29861 | 52.07667 | 0 | NCT00687609 |
[
5
] | 261 | NA | SINGLE_GROUP | 9OTHER | 0NONE | false | 1FEMALE | false | This study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole | This is a multi-center prospective non-randomized single arm, open label trial in postmenopausal HR positive early breast cancer patients who experience grade 2-3 arthralgia-myalgia while on anastrozole, resulting in the discontinuation of anastrozole. After a 2-3 week period without any aromatase inhibitor treatment, ... | Breast Cancer | breast cancer adjuvant treatment in post menopausal women letrozole arthralgia-myalgia | null | 1 | arm 1: Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks. | [
0
] | 1 | [
0
] | intervention 1: 2.5 mg daily by mouth for 6 months | intervention 1: letrozole | 48 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Grass Valley | California | United States | -121.06106 | 39.21906
Palm Springs | California | United States | -116.54529 | 33.8303
Pleasant Hill | California | United States | -122.0608 | 37.94798
Fo... | 0 | NCT00688909 |
[
5
] | 384 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension | null | Hypertension | Systolic blood pressure Diastolic blood pressure Valsartan Hydrochlorothiazide | null | 3 | arm 1: (patients initiated on valsartan) arm 2: (patients initiated on HCTZ) arm 3: (patients initiated on Valsartan+HCTZ) | [
1,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12. intervention 2: At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal \<140/90 mmHg... | intervention 1: Valsartan + HCTZ intervention 2: Valsartan intervention 3: HCTZ | 20 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Escondido | California | United States | -117.08642 | 33.11921
Fresno | California | United States | -119.77237 | 36.74773
Huntington Park | California | United States | -118.22507 | 33.98168
Pismo Beac... | 0 | NCT00698646 |
[
4
] | 400 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery. | null | Ocular Inflammation | null | 2 | arm 1: Loteprednol Etabonate 0.5% arm 2: Vehicle of Ophthalmic Loteprednol Etabonate | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days. intervention 2: Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days. | intervention 1: Loteprednol Etabonate intervention 2: Vehicle of Ophthalmic Loteprednol Etabonate | 1 | High Point | North Carolina | United States | -80.00532 | 35.95569 | 0 | NCT00699153 | |
[
3
] | 1 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ICH). | Intracerebral hemorrhage (ICH) causes 10% to 15% of first-ever strokes, with a 30-day mortality rate of 35% to 52% with only 20% expected to be functionally independent at 6 months. No medical or surgical interventions have been found to alter the natural evolution of this disease. The high risk for mortality and poor ... | Intracerebral Hemorrhage | Intracerebral Hemorrhage Edema Statins | null | 2 | arm 1: Simvastatin Group arm 2: Placebo Group | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge. intervention 2: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge. | intervention 1: Simvastatin 80 mg intervention 2: Placebo | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00718328 |
[
5
] | 115 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | false | We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia. | null | Postoperative Nausea and Vomiting | PONV nausea emesis antiemetics aprepitant ondansetron dexamethasone | null | 2 | arm 1: Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia arm 2: Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Aprepitant 40 mg + Dexamethasone 10 mg intervention 2: Ondansetron 4 mg + Dexamethasone 10 mg | intervention 1: Aprepitant + Dexamethasone intervention 2: Ondansetron + Dexamethasone | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00734929 |
[
3
] | 101 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this st... | null | Diabetes | Diabetes Type 2 Diabetes Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders Glycemic Control | null | 2 | arm 1: Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) arm 2: Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) | [
0,
0
] | 1 | [
0
] | intervention 1: Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks | intervention 1: VI-0521 | 9 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Spring Valley | California | United States | -116.99892 | 32.74477
Walnut Creek | California | United States | -122.06496 | 37.9... | 0 | NCT00737633 |
[
5
] | 76 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's Global Assessment (PGA - H\&F) greater-than or equal to 3 in subjects not suitable for other systemic therapies including cyclosporine, methot... | null | Chronic Plaque Psoriasis | Efalizumab, Chronic plaque psoriasis moderate to severe involving hands feet | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the pl... | intervention 1: Efalizumab - anti CD11a recombinant human monoclonal antibody intervention 2: Placebo | 1 | Vienna | N/A | Austria | 16.37208 | 48.20849 | 0 | NCT00739882 |
[
2
] | 16 | NON_RANDOMIZED | PARALLEL | null | 0NONE | true | 1FEMALE | false | This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function. | 16 subjects will be allocated to 2 groups. The test group will consist of 8 female patients with moderately impaired hepatic function meeting the Child-Pugh Class B severity criteria, while the control group will consist of 8 healthy female adult volunteers. During Stage I, all subjects will receive a single oral dose ... | Impaired Liver Function | null | 2 | arm 1: Proellex 25 mg in healthy females arm 2: Proellex 50 mg in hepatically impaired females | [
0,
0
] | 1 | [
0
] | intervention 1: Proellex 25 mg capsule, single dose | intervention 1: Proellex | 2 | Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834 | 0 | NCT00741273 | |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL | In this open study, patients will enter a baseline period of 6 days where the pancreatic enzyme therapy will be discontinued and a standard diet given. After the baseline period, patients will enter a treatment period of 6 days where a fixed dose of BSSL will be administered. The primary efficacy measurements will be m... | Cystic Fibrosis Exocrine Pancreatic Insufficiency | cystic fibrosis pancreatic insufficiency bucelipase alfa bile salt stimulating lipase BSSL coefficient of fat absorption | null | 1 | arm 1: 170 mg rhBSSL three times daily for 5 to 6 consecutive days | [
0
] | 1 | [
0
] | intervention 1: oral suspension, 170 mg BSSL, 3 times daily for 5-6 days | intervention 1: rhBSSL | 4 | Rotterdam | N/A | Netherlands | 4.47917 | 51.9225
Gdansk | N/A | Poland | 18.64912 | 54.35227
Poznan | N/A | Poland | 16.92993 | 52.40692
Rabka-Zdrój | N/A | Poland | 19.96654 | 49.60889 | 0 | NCT00743483 |
[
4
] | 140 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The current trial was designed to demonstrate faster recovery in participants undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PT... | null | Anesthesia Neuromuscular Blockade | null | 2 | arm 1: Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium arm 2: Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium | [
0,
2
] | 2 | [
0,
0
] | intervention 1: At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of 4.0 mg.kg-1 sugammadex (volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion. intervention 2: At a target depth of NMB of 1-2 PTC after... | intervention 1: Sugammadex intervention 2: 0.9% sodium chloride (NaCl) | 0 | null | 0 | NCT00758485 | |
[
3
] | 52 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease | null | Chronic Obstructive Pulmonary Disease | COPD Moderate to severe COPD | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Oral tablet, twice daily, 4 weeks treatment intervention 2: Placebo | intervention 1: AZD1981 intervention 2: Placebo | 8 | Frieburg | N/A | Germany | N/A | N/A
Großhansdorf | N/A | Germany | 10.28333 | 53.66667
Hanover | N/A | Germany | 9.73322 | 52.37052
Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
Leicester | N/A | United Kingdom | -1.13169 | 52.6386
London | N/A | United Kingdom | -0.12574 | 51.50853
Manchester | N/A | United King... | 0 | NCT00766415 |
[
4
] | 144 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis. | null | Allergic Conjunctivitis | null | 4 | arm 1: KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution arm 2: Naphazoline HCl 0.05% ophthalmic solution arm 3: Ketotifen fumarate 0.025% ophthalmic solution arm 4: Vehicle of KetoNaph ophthalmic solution | [
0,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4. intervention 2: One drop of Ketotifen in study eye at visit 3 and visit 4. intervention 3: One drop of naphazoline in study eye at vist 3 and visit 4. intervention 4: One drop of vehicle in study eye at visit 3 and visit 4. | intervention 1: Ketotifen/naphazoline intervention 2: Ketotifen intervention 3: Naphazoline intervention 4: Vehicle | 1 | North Andover | Massachusetts | United States | -71.13506 | 42.6987 | 0 | NCT00769886 | |
[
4
] | 276 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study objective was to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over placebo by evaluation of treatment success analyzing the investigator's rating on the Facial Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients with moderate to severe glabellar frown line... | The study was a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter phase 3 clinical trial. Approximately 285 females and males with moderate to severe glabellar frown lines at maximum frown were to be screened during a screening period of four months in order to randomize approximate... | Moderate to Severe Glabellar Frown Lines | null | 2 | arm 1: IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitutio... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL. intervention 2: The tr... | intervention 1: IncobotulinumtoxinA (Xeomin) (20 Units) intervention 2: Placebo | 8 | Los Angeles | California | United States | -118.24368 | 34.05223
Meatrie | Louisiana | United States | N/A | N/A
Chestnut Hill | Massachusetts | United States | -71.16616 | 42.33065
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Nashville | Tennessee | United States | -86.78444 | 36.16589
Vancouver | Br... | 0 | NCT00770029 | |
[
4
] | 271 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study objective is to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over placebo by evaluation of treatment success analyzing the investigator's rating on the Facial Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients with moderate to severe glabellar frown lines... | The study was a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter phase 3 clinical trial. Approximately 285 females and males with moderate to severe glabellar frown lines at maximum frown were to be screened during a screening period of four months in order to randomize approximate... | Moderate to Severe Glabellar Frown Lines | null | 2 | arm 1: IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitutio... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL. intervention 2: The tr... | intervention 1: IncobotulinumtoxinA (Xeomin) (20 Units) intervention 2: Placebo | 8 | Englewood | Colorado | United States | -104.98776 | 39.64777
Aventura | Florida | United States | -80.13921 | 25.95648
Coral Gables | Florida | United States | -80.26838 | 25.72149
Lincolnshire | Illinois | United States | -87.9084 | 42.19002
Carmel | Indiana | United States | -86.11804 | 39.97837
Omaha | Nebraska | Un... | 0 | NCT00770211 | |
[
5
] | 37 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | false | PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal models. This study tests the hypothesis that pentoxifyllin... | Obese individuals with elevated PAI-1 levels (greater than 10 ng/ml) are randomized to pentoxifylline 400mg, three times a day (TID) or placebo for 8 weeks. PAI-1, TNF-a and high sensitivity C-Reactive Protein are measured at week 0, 4 and 8. | Obesity | Plasma PAI-1 level at 0, 4, 8 weeks Plasma hsCRP level at 0, 4, 8 weeks Plasma TNF-a level at 0, 4, 8 weeks | null | 2 | arm 1: Patients receive Pentoxifylline 400 mg po TID for 8 weeks. arm 2: Patients take a placebo TID for 8 weeks. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 400mg PO TID x 8 weeks intervention 2: PO TID x 8 weeks | intervention 1: Pentoxifylline intervention 2: Placebo | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00770328 |
[
4
] | 6 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to demonstrate that MK0826 is comparable to Meropenem in the treatment of complicated Urinary Tract Infections (UTIs) in adults. | null | Urinary Tract Infections | null | 2 | arm 1: MK0826 (ertapenem) arm 2: meropenem | [
0,
1
] | 2 | [
0,
0
] | intervention 1: A single dose of 1.0g IV infused over a 30 minute interval at hour 0 intervention 2: 500 mg IV infused over a 30 minute interval at hours 0, 8, and 16 for at least 4 days | intervention 1: MK0826 (ertapenem) intervention 2: Comparator: meropenem | 0 | null | 0 | NCT00771316 | |
[
4
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis. | null | Cystic Fibrosis Pancreatic Exocrine Insufficiency | Cystic Fibrosis Pancreatic Exocrine Insufficiency | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 3,000, 6,000 and 12,000 unit Lipase Capsules | intervention 1: Pancrelipase Delayed Release | 12 | Boise | Idaho | United States | -116.20345 | 43.6135
Louisville | Kentucky | United States | -85.75941 | 38.25424
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Detroit | Michigan | United States | -83.04575 | 42.33143
Minneapolis | Minnesota | ... | 0 | NCT00775528 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.