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
] | 52 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer.
* If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer.
* If BAY43-9006 helps to slow the worsening of non-s... | In addition to the key secondary outcome parameters several potential biomarkers were evaluated as exploratory parameters.
Issues on safety are addressed in the Adverse Event section.
The following acronyms and abbreviations were used in the Adverse Event section and Limitations and Caveats section:
* gastrointestin... | Cancer Carcinoma, Non-Small Cell Lung | NSCLC | null | 1 | arm 1: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles | [
0
] | 1 | [
0
] | intervention 1: BAY43-9006 400 mg bid X 28 day cycles \[Continuous treatment for a maximum of 2 years; potential for compassionate use and long term survival follow-up post drug discontinuation. | intervention 1: Sorafenib (Nexavar, BAY43-9006) | 2 | Houston | Texas | United States | -95.36327 | 29.76328
Großhansdorf | Schleswig-Holstein | Germany | 10.28333 | 53.66667 | 0 | NCT00101413 |
[
5
] | 177 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will determine the efficacy of escitalopram (Lexapro®), an anti-anxiety drug, for generalized anxiety disorder (GAD) and the ways genetics affect response to treatment for GAD in elderly individuals. | GAD is a serious public health issue; particularly among the elderly, prevalence of the condition is high, and functional burden on those with the illness is significant. GAD is associated with irregular levels of neurotransmitters, chemicals that carry messages across nerve endings. Serotonin is a neurotransmitter tha... | Anxiety Disorders Generalized Anxiety Disorder | Anxiety Elderly Aged Serotonin Reuptake Inhibitors SSRI SERT | null | 2 | arm 1: Escitalopram arm 2: Placebo | [
0,
2
] | 1 | [
0
] | intervention 1: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram. | intervention 1: Escitalopram | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00105586 |
[
3
] | 96 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC). | In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations.
The possible and potential predictive assays of cl... | Carcinoma, Hepatocellular | Cancer Liver Cancer Hepatocellular carcinoma HCC | null | 2 | arm 1: "Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks) arm 2: "Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets ... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Multi kinase inhibitor plus Chemotherapy intervention 2: Chemotherapy plus Placebo | intervention 1: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin intervention 2: Doxorubicin/Placebo | 28 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Beverly Hills | California | United States | -118.40036 | 34.07362
Orange | California | United States | -117.85311 | 33.78779
Palo Alto | California | United States | -122.14302 | 37.44188
San Francisco | California | United States | -122.41942 | 37.77493
San... | 0 | NCT00108953 |
[
3
] | 9 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 1FEMALE | true | RATIONALE: St. John's wort may help relieve hot flashes in women with breast cancer.
PURPOSE: This phase II trial is studying how well St. John's wort works in relieving hot flashes in women with non-metastatic breast cancer. | OBJECTIVES:
Primary
* Determine the efficacy of Hypericum perforatum (St. John's wort) in alleviating hot flashes, in terms of hot flash frequency, score, and duration and disruption of daily activities caused by hot flashes, in postmenopausal women with non-metastatic breast cancer.
* Determine hot flash changes ove... | Breast Cancer Hot Flashes | recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer breast cancer in situ ductal breast carcinoma in situ hot flashes | null | 1 | arm 1: Patient given one 300mg St. John's Wort tablet three times per day | [
0
] | 1 | [
0
] | intervention 1: St. John's Wort 300mg tablet three times per day | intervention 1: St. John's Wort | 19 | Newark | Delaware | United States | -75.74966 | 39.68372
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Miami | Florida | United States | -80.19366 | 25.77427
Decatur | Illinois | United States | -88.9548 | 39.84031
South Bend | Indiana | United States | -86.25001 | 41.68338
Shreveport | ... | 0 | NCT00110136 |
[
3
] | 212 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will examine the long-term safety and efficacy of Deferasirox in patients with sickle cell disease and iron overload from repeated blood transfusions. | null | Sickle Cell Disease Iron Overload Hemolytic Anemia | Sickle Cell Disease Iron Overload from Repeated Blood Transfusions Iron Overload Blood Transfusions | null | 2 | arm 1: Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. arm 2: Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day. intervention 2: Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg. | intervention 1: Deferasirox (ICL670) intervention 2: Deferoxamine (DFO) | 59 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Mobile | Alabama | United States | -88.04305 | 30.69436
Loma Linda | California | United States | -117.26115 | 34.04835
Oakland | California | U... | 0 | NCT00110617 |
[
3
] | 56 | RANDOMIZED | PARALLEL | null | 2DOUBLE | false | 0ALL | false | The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2). | null | Arthritis, Rheumatoid | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: solution, intravenous injection, monthly, 169 days
weight based:
\<60 kg = 500 mg
60 to 100 kg = 750 mg
\>100 kg = 1 g intervention 2: solution, intravenous injection, 0 mg, monthly, 169 days | intervention 1: Abatacept intervention 2: placebo | 48 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Mobile | Alabama | United States | -88.04305 | 30.69436
Huntington Beach | California | United States | -117.99923 | 33.6603
Los Angeles | California | United States | -118.24368 | 34.05223
Boulder | Colorado | United States | -105.27055 | 40.01499
Colorado Spr... | 0 | NCT00124449 | |
[
3
] | 90 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate the safety and efficacy of three target doses of melperone compared to placebo in the treatment of psychosis associated with Parkinson's disease. Subjects will be enrolled at approximately 20 investigational sites in the United States (U.S.) and 15 Ex-US sites. The maximum study... | Parkinson's Disease is a progressive neurodegenerative disorder characterized by bradykinesia, rigidity, tremor and abnormal posture and gait. Many patients can have mild to moderate symptoms, while others with advanced disease have symptoms which interfere with activities of daily living to a severe degree. Although e... | Parkinson's Disease Psychotic Disorders | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 20 mg/day. Strength of melperone syrup is 5 mg/mL intervention 2: 40 mg/day. Strength of melperone syrup is 5 mg/mL intervention 3: 60 mg/day. Strength of melperone syrup is 5 mg/mL intervention 4: Syrup formulation | intervention 1: Melperone HCl intervention 2: Melperone HCl intervention 3: Melperone HCl intervention 4: Placebo | 21 | Tucson | Arizona | United States | -110.92648 | 32.22174
Bradenton | Florida | United States | -82.57482 | 27.49893
Tampa | Florida | United States | -82.45843 | 27.94752
Kansas City | Kansas | United States | -94.62746 | 39.11417
Bingham Farms | Michigan | United States | -83.27326 | 42.51587
Golden Valley | Minnesota... | 0 | NCT00125138 | |
[
3
] | 210 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Despite years of active research, there are still no approved medications for the treatment of cocaine dependence. The purpose of this study is to determine the effectiveness of modafinil in treating cocaine-dependent individuals. | Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled conditions. Due to its stimulant-like properties, modafinil is also likely to relieve severe cocaine withdrawal symptoms. In turn, this may lead to better clinical outcomes. The purpose of this study is to determine whether modafinil... | Cocaine-Related Disorders | cocaine | null | 3 | arm 1: Low Dose Modafinil 200 mg daily arm 2: High dose modafinil 400 mg daily arm 3: Placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: modafinil 200 mg/day intervention 2: modafinil 400 mg/day intervention 3: placebo 400 mg/day | intervention 1: Low Dose Modafinil intervention 2: High Dose Modafinil intervention 3: Placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00129285 |
[
3
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects are and how long the benefit will last. | * The study drug CC-5103 (lenalidomide) will be administered orally once daily for 21 days followed by 7 days of no CC-5103 (lenalidomide) (this will be one 28 day treatment cycle). This cycle will repeat itself every 28 days as long as the patient is tolerating the medication and there is no disease progression.
* Sta... | Waldenstrom's Macroglobulinemia | CC-5103 (lenalidomide) rituximab Waldenstrom's macroglobulinemia | null | 1 | arm 1: Intended therapy consisted of 48 weeks of CC-5103 (lenalidomide)(25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16. | [
0
] | 2 | [
0,
0
] | intervention 1: Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide) intervention 2: Begins on week 2 of treatment and is given intravenously once a week for 4 weeks | intervention 1: CC-5103 (lenalidomide) intervention 2: Rituximab | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00142168 |
[
5
] | 45 | NON_RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | true | To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants | null | Prophylaxis Of Invasive Fungal Infections | Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Voriconazole is given to patients at least 48 hours after chemotherapy | intervention 1: voriconazole | 17 | Leuven | N/A | Belgium | 4.70093 | 50.87959
Marseille | Cedex 09 | France | 5.38107 | 43.29695
Créteil | N/A | France | 2.46569 | 48.79266
Nantes | N/A | France | -1.55336 | 47.21725
Pessac | N/A | France | -0.6324 | 44.80565
Strasbourg | N/A | France | 7.74553 | 48.58392
Cologne | N/A | Germany | 6.95 | 50.93333
Mainz... | 0 | NCT00143312 |
[
3
] | 143 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will examine the effectiveness and safety of a combination treatment for cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency syndrome (AIDS) in the developing world. The standard initial treatment includes two medications: amphotericin B for 2 weeks followed by 8 wee... | This study is designed to address the need for more effective antifungal therapy for cryptococcal meningitis. This is a prospective, randomized, open-label, multicenter phase II clinical trial of combination therapy for the treatment of acute cryptococcal meningitis in HIV-positive subjects. The primary study objective... | Cryptococcal Meningitis | Bacterial infections, HIV infection, cryptococcal meningitis | null | 3 | arm 1: Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed. arm 2: Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for th... | [
1,
0,
0
] | 2 | [
0,
0
] | intervention 1: Amphotericin B 0.7 mg/kg IV for the first 14 days of treatment. This period may be extended up to an additional 7 days. intervention 2: Fluconazole 400 or 800 mg daily. Among subjects whose baseline weight is less than 40 kg, randomized fluconazole doses will be 200 mg/kg daily or 400 mg/kg daily. | intervention 1: Amphotericin B intervention 2: Fluconazole | 15 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Denver | Colorado | United States | -104.9847 | 39.73915
Gainesville | Florida | United States | -82.32483 | 29.65163
Miami | Flor... | 0 | NCT00145249 |
[
3
] | 50 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma. | * Treatment with trabectedin will be given once a week for three consecutive weeks with one week of no treatment. This four week period constitutes one cycle.
* Trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours.
* On day 1 of each cycle a history, physical exam and b... | Prostate Cancer | Advanced Prostate Cancer Prostate Cancer Trabectedin ET 743 Yondelis | null | 1 | arm 1: ET-743 | [
0
] | 1 | [
0
] | intervention 1: ET-743 administered IV by 24-hr infusion every 3 weeks | intervention 1: ET 743 | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00147212 |
[
4
] | 506 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to r... | null | Transfusional Iron Overload in β-thalassemia | β-thalassemia iron overload deferasirox | null | 1 | arm 1: All participants received Deferasirox (ICL670) orally once a day. Dosage based on body weight. | [
0
] | 1 | [
0
] | intervention 1: Tablets taken orally once a day. | intervention 1: Deferasirox | 49 | Los Angeles | California | United States | -118.24368 | 34.05223
Oakland | California | United States | -122.2708 | 37.80437
Stanford | California | United States | -122.16608 | 37.42411
Chicago | Illinois | United States | -87.65005 | 41.85003
Boston | Massachusetts | United States | -71.05977 | 42.35843
Philadelphia ... | 0 | NCT00171210 |
[
5
] | 14 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | false | 0ALL | true | In this trial, eligible patients will be randomly assigned to receive a single dose of 400 mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their usual medications for CDAD. We expect to enroll approximately 40 patients over a period of two years from UPMC Shadyside Hospital, McKeespo... | See "Brief Summary" for details | Clostridium Difficile-associated Diarrhea (CDAD) | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: IVIG to be given IV to patients with C-Diff . intervention 2: Placebo to be given IV to patients with C-Diff | intervention 1: intravenous immunoglobulin G (IVIG) intervention 2: Placebo | 4 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00177970 | |
[
3
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | null | The purpose of this study is to determine if treatment using a medication (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a tablet that does not contain any active medication, when combined with testosterone replacement to treat reproductive and sexual dysfunction in men with e... | This is a three-month study where baseline information is collected at the first visit and then each patient is started on treatment with testosterone supplementation and either anastrozole or placebo. Lab tests, seizure frequency, sexual function and mood will be monitored on a monthly basis. | Seizure Disorder Hypogonadism Erectile Dysfunction | Seizure Epilepsy Testosterone Hormone Sexual Dysfunction Hypogonadism Men | null | 2 | arm 1: Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes an oral tablet of anastrozole 1 mg daily for the duration of the study. This group is referred to as the depotestosterone plus anastrozole (T-A) group. arm 2: Each participant has biweekly intramuscular injectio... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Anastrozole 1mg intervention 2: Placebo Oral Tablet | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00179517 |
[
3
] | 43 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Subjects who qualify will receive lenalidomide daily on days 1-21 of every 28-day cycle. Treatment will continue for up to 52 weeks or until disease progression; subjects who achieve a Complete Response (CR) will receive an additional 2 cycles of treatment prior to discontinuation. Subjects will be followed for progres... | null | Non-Hodgkins Lymphoma | NHL CC5013 Non-Hodgkins Lymphoma revlimid cc-5013 celgene | null | 1 | arm 1: Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Lenalidomide | 15 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Berkeley | California | United States | -122.27275 | 37.87159
Fountain Valley | California | United States | -117.95367 | 33.70918
Chicago | Illinois | United States | -87.65005 | 41.85003
Boston | Massachusetts | United States | -71.05977 | 42.35843
Rocheste... | 0 | NCT00179673 |
[
5
] | 51 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II... | Lamotrigine is a new generation antiepileptic drug, approved by the FDA in 2003 for the maintenance treatment of adults with Bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania,\& mixed episodes) in patients treated for acute mood episodes with standard therapy. Recent stud... | Bipolar Disorder Mania | bipolar disorder lamotrigine children mania | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Open-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children \<12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divid... | intervention 1: lamotrigine | 1 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751 | 0 | NCT00181844 |
[
5
] | 23 | NON_RANDOMIZED | PARALLEL | null | 0NONE | true | 0ALL | true | The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. We will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation in hOCT2 is associated with variation in... | The drug, which is used in the treatment of Type II diabetes, has a narrow therapeutic range. Its net renal clearance by secretion (i.e., renal clearance minus filtration clearance) ranges from approximately 100 ml/min to 800ml/min in normal, healthy subjects. Although many factors may contribute to inter-individual va... | Other Conditions That May Be A Focus of Clinical Attention | Healthy Control | null | 2 | arm 1: Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin. arm 2: Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin. | [
0,
0
] | 1 | [
0
] | intervention 1: Subjects will be given a single oral dose of 850 mg of metformin | intervention 1: Metformin | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00187720 |
[
3
] | 60 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy.
Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluatio... | As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. | Leukemia, Lymphocytic, Chronic, B-Cell | null | 1 | arm 1: Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days. | [
0
] | 1 | [
0
] | intervention 1: Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days | intervention 1: Alemtuzumab plus Fludarabine | 27 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Berkeley | California | United States | -122.27275 | 37.87159
Burbank | California | United States | -118.30897 | 34.18084
Concord | California | United States | -122.03107 | 37.97798
Stanford | California | United States | -122.16608 | 37.42411
Washington D.C... | 0 | NCT00206726 | |
[
3
] | 68 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer. | This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer. An approved bisphosphonate, alendronate, is of benefit in patients with osteoporosis, however, this agent has a roughly 30% incidence of ... | Breast Cancer | bone mineral density postmenopausal women | null | 2 | arm 1: Observation only for 12 months arm 2: Zoledronate | [
4,
1
] | 1 | [
0
] | intervention 1: 4 mg IV over 15 minutes administered once every 12 weeks times 4 | intervention 1: Zoledronate | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00213980 |
[
4
] | 539 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). | This Phase 3 study is being conducted in Europe, Israel, Australia, and South Africa to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).... | Seizures | Partial Seizures Complex Partial Seizures Epilepsy Potassium Channels Anticonvulsant | null | 3 | arm 1: None arm 2: None arm 3: None | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase. intervention 2: Oral ta... | intervention 1: Retigabine intervention 2: Retigabine intervention 3: Placebo | 70 | Bethesda | Maryland | United States | -77.10026 | 38.98067
Dallas | Texas | United States | -96.80667 | 32.78306
Camperdown | New South Wales | Australia | 151.17642 | -33.88965
Maroochydore | Queensland | Australia | 153.09953 | -26.66008
Clayton | Victoria | Australia | 145.11667 | -37.91667
Parkville | Victoria | Au... | 0 | NCT00235755 |
[
4
] | 435 | NON_RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a ... | This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial. | Computed Tomography Diagnostic Imaging | Ultravist 370 CECT CT Scan | null | 2 | arm 1: Iopromide (Ultravist 370 mg I/mL) administered intravenously arm 2: Iopromide (Ultravist 300 mg I/mL) administered intravenously | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Iopromide (Ultravist 370 mg I/mL) administered intravenously intervention 2: Iopromide (Ultravist 300 mg I/mL) administered intravenously | intervention 1: Iopromide 370 mg I/mL intervention 2: Iopromide 300 mg I/mL | 23 | Tucson | Arizona | United States | -110.92648 | 32.22174
Miami | Florida | United States | -80.19366 | 25.77427
Tallahassee | Florida | United States | -84.28073 | 30.43826
Atlanta | Georgia | United States | -84.38798 | 33.749
Atlanta | Georgia | United States | -84.38798 | 33.749
Evanston | Illinois | United States |... | 0 | NCT00244140 |
[
4
] | 1,294 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily. | The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily. | Postmenopausal Osteoporosis | randomized controlled trial, osteoporosis, risedronate | null | 2 | arm 1: 5 mg risedronate, once daily for 2 years arm 2: 150 mg risedronate taken once a month for 2 years | [
1,
0
] | 2 | [
0,
0
] | intervention 1: tablet, 5 mg risedronate, once a day for 2 years intervention 2: oral, 150 mg risedronate, once a month for 2 years | intervention 1: risedronate intervention 2: risedronate | 49 | Lakewood | Colorado | United States | -105.08137 | 39.70471
Gainesville | Georgia | United States | -83.82407 | 34.29788
Bethesda | Maryland | United States | -77.10026 | 38.98067
Omaha | Nebraska | United States | -95.94043 | 41.25626
West Haverstraw | New York | United States | -73.98542 | 41.20954
Cincinnati | Ohio ... | 0 | NCT00247273 |
[
4
] | 4,717 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy.
The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant... | null | Type 2 Diabetes | Diabetes mellitus type 2 | null | 2 | arm 1: candesartan cilexetil 32 mg once daily arm 2: control | [
0,
4
] | 1 | [
0
] | intervention 1: 32 mg oral tablet | intervention 1: candesartan | 0 | null | 0 | NCT00252694 |
[
5
] | 275 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study is designed to investigate the use of omalizumab as a pretreatment for patients with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy shots) and will test the hypothesis that omalizumab may reduce the rate of systemic reactions to immunotherapy in patients with persistent... | null | Allergic Asthma | Allergic Asthma, IgE, immunotherapy, omalizumab | null | 2 | arm 1: The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram. arm 2: The... | [
2,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Doses of placebo were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on the patient's body weight and baseline serum IgE. intervention 2: Doses of omalizumab were administered subcutaneously every 2 to 4 weeks according to the US product label, depending on t... | intervention 1: Placebo intervention 2: Omalizumab intervention 3: Immunotherapy intervention 4: Immunotherapy | 1 | East Hanover | New Jersey | United States | -74.36487 | 40.8201 | 0 | NCT00267202 |
[
3
] | 4 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The goal of this clinical research study is to learn how the drug ZD6474 affects the amount of tumor cell death in the body and the amount of blood that can be supplied to the tumor. The safety of ZD6474 alone and when given with chemotherapy will be studied. In addition, the side effects and response to this treatment... | ZD6474 is a new investigational drug that is thought to block the formation of new blood vessels. The growth of new blood vessels is called angiogenesis. Angiogenesis is thought to be essential for the growth of tumors beyond a small size. It is hoped that ZD6474 will limit new blood vessel growth in the tumor and "sta... | Lung Cancer | Non-Small Cell Lung Cancer Lung Cancer Carboplatin Paclitaxel ZD6474 NSCLC | null | 3 | arm 1: First part of two part treatment, Part One: three 3-week cycles 300 mg of ZD6474 daily. Second part, Part Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m\^2 IV over 3 hours on Day 1 ever... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: ZD6474 alone: Cycles 1-3 = 300 mg PO Daily x 3 Weeks; ZD6474+Carboplatin+Paclitaxel = 300 mg oral (PO) Daily or 100 mg PO Daily plus Carboplatin and Paclitaxel Every 3 Weeks. intervention 2: 6 AUC IV Over 15-30 Minutes, Immediately After Paclitaxel intervention 3: 200 mg/m\^2 IV Over 3 Hours On Day 1 | intervention 1: ZD6474 intervention 2: Carboplatin intervention 3: Paclitaxel | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00290537 |
[
4
] | 130 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam... | null | Epilepsy | NEWLY DIAGNOSED EPILEPSY LEVETIRACETAM KEPPRA N01175 (NCT00175903) | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study | intervention 1: Levetiracetam | 35 | Bruges | N/A | Belgium | 3.22424 | 51.20892
Edegem | N/A | Belgium | 4.44504 | 51.15662
Ghent | N/A | Belgium | 3.71667 | 51.05
Haine-Saint-Paul | N/A | Belgium | 4.1885 | 50.45544
Jette | N/A | Belgium | 4.33419 | 50.87309
Kortrijk | N/A | Belgium | 3.26487 | 50.82803
Leuven | N/A | Belgium | 4.70093 | 50.87959
Ostend... | 0 | NCT00291655 |
[
4
] | 696 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg d... | This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg d... | Hepatitis C, Chronic | Hepatitis C, Chronic Genotype 2 and Genotype 3 | null | 3 | arm 1: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks arm 2: PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks arm 3: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC... | [
1,
0,
0
] | 5 | [
2,
2,
2,
0,
0
] | intervention 1: 1.5 mcg/kg QW SC for 24 weeks intervention 2: 1.0 mcg/kg QW SC for 24 weeks intervention 3: 1.5 mcg/kg QW SC for 16 weeks intervention 4: 800-1200 mg daily for 24 weeks intervention 5: 800-1200 mg daily for 16 weeks | intervention 1: peginterferon alfa-2b (SCH 54031) intervention 2: peginterferon alfa-2b (SCH 54031) intervention 3: peginterferon alfa-2b (SCH 54031) intervention 4: ribavirin (SCH 18908) intervention 5: ribavirin (SCH 18908) | 0 | null | 0 | NCT00302081 |
[
5
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in... | Cognitive function is one of the most critical deficits in schizophrenia and schizoaffective disorder. It has been found that cognitive dysfunction may be even more important than positive or negative symptoms in predicting functional outcomes such as community adjustment, ability to work, social interactions, and care... | Schizophrenia Schizoaffective Disorder | schizophrenia, cognition, mood stabilizer | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: divalproex sodium extended-release (ER) 1000 mg intervention 2: placebo identical in appearance to active comparator | intervention 1: Divalproex Sodium Extended-Release Tablets intervention 2: placebo | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00306475 |
[
5
] | 694 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension. | null | Essential Hypertension | Olmesartan medoxomil Hypertension | null | 1 | arm 1: Olmesartan medoxomil oral tablets for 4 weeks followed by, if necessary:
Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets for 8 weeks, followed by, if necessary:
Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets + amlodipine oral tablets for 8 weeks | [
0
] | 1 | [
0
] | intervention 1: Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed... | intervention 1: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary | 79 | Fulpmes | N/A | Austria | 11.34922 | 47.15202
Innsbruck | N/A | Austria | 11.39454 | 47.26266
Innsbruck | N/A | Austria | 11.39454 | 47.26266
Kundl | N/A | Austria | 11.98333 | 47.46667
Salzburg | N/A | Austria | 13.04399 | 47.79941
Salzburg-Aigen | N/A | Austria | N/A | N/A
Brussels | N/A | Belgium | 4.34878 | 50.8504... | 0 | NCT00311155 |
[
5
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 0ALL | false | Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients. | A placebo-controlled, double-blind, crossover trial will be conducted providing study subjects either hydrocodone/acetaminophen 30mg/975mg, sustained release morphine 45mg or placebo on separate GCRC visits. A long acting comparator (slow-release morphine sulfate 45 mg) will be chosen because of its putative equianalge... | Chronic Pain | Chronic Pain Opioids | null | 3 | arm 1: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
On one of three study dates, subjects received ER morphine tablets, 45 mg (Mallinckrodt Pharmaceuticals, St. Louis, MO). The dose of ER morphine sulfate (45 mg) was selected because of its approximate equianalgesic effect to the dose of hydrocod... | [
1,
1,
2
] | 4 | [
5,
0,
0,
0
] | intervention 1: The first dose of the study medication was taken following collection of baseline measurements, and subsequent measurements were taken hourly thereafter. Respiration, heart rate, arterial oxygen saturation (pulse oximetry), and blood pressure were also monitored at these intervals to insure the safety o... | intervention 1: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity intervention 2: ER Morphine intervention 3: hydrocodone plus acetaminophen intervention 4: placebo | 0 | null | 0 | NCT00314340 |
[
5
] | 220 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors. | Original French title of the study: Etude de phase IV, multicentrique, randomisée, ouverte, comparant les réactions et la douleur aux sites d'injection après administration sous-cutanée d'interféron β-1b (Betaferon®) ou interféron β-1a (Rebif®) pendant la période de trois mois d'initiation de la thérapie chez des patie... | Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis RRMS | null | 3 | arm 1: Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject arm 2: Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light arm 3: Interfero... | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 250ug administrated with Betaject intervention 2: 44ug administered with Rebiject II intervention 3: 250ug administrated with Betaject light | intervention 1: Betaferon/Betaseron intervention 2: Rebif intervention 3: Betaferon/Betaseron | 59 | Aix-en-Provence | N/A | France | 5.44973 | 43.5283
Alkirch | N/A | France | N/A | N/A
Annecy | N/A | France | 6.12565 | 45.90878
Aurillac | N/A | France | 2.43983 | 44.92539
Belfort | N/A | France | 6.85385 | 47.64218
Blaye | N/A | France | -0.66225 | 45.12764
Bordeaux | N/A | France | -0.5805 | 44.84044
Boulogne-sur-M... | 0 | NCT00317941 |
[
4
] | 55 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes duri... | null | Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency | Immunoglobulin Intravenous Agammaglobulinemia Hypogammaglobulinemia Common variable immunodeficiency Immunoglobulin G Children | null | 1 | arm 1: See Intervention Description | [
0
] | 1 | [
0
] | intervention 1: Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw | intervention 1: Immunoglobulins Intravenous (Human) | 10 | Los Angeles | California | United States | -118.24368 | 34.05223
Centennial | Colorado | United States | -104.87692 | 39.57916
North Palm Beach | Florida | United States | -80.08199 | 26.81756
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Indi... | 0 | NCT00322556 |
[
4
] | 531 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A. This study will assess the safety and efficacy of ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal neovascularization (CNV) secondary to age-relate... | null | Age Related Macular Degeneration Choroidal Neovascularization | AMD, ranibizumab | null | 1 | arm 1: Ranibizumab-naïve (Non-ANCHOR) patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.... | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Ranibizumab | 1 | Basel | N/A | Switzerland | 7.57327 | 47.55839 | 0 | NCT00331864 |
[
4
] | 98 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD). | null | Autistic Disorder | Serious behavioral problems in children and adolescents with AD Behavioral Problems | null | 2 | arm 1: Active Abilify arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks intervention 2: Tablets, Oral, once daily, 8 weeks | intervention 1: Aripiprazole intervention 2: Placebo | 9 | Boca Raton | Florida | United States | -80.0831 | 26.35869
Atlanta | Georgia | United States | -84.38798 | 33.749
Louisville | Kentucky | United States | -85.75941 | 38.25424
Bloomfield Hills | Michigan | United States | -83.24549 | 42.58364
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Stony Brook | New Y... | 0 | NCT00332241 |
[
4
] | 214 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305. | null | Type II Diabetes Mellitus Dyslipidemia | Pitavastatin Type II Diabetes Mellitus Combined Dyslipidemia | null | 2 | arm 1: Pitavastatin 4 mg QD arm 2: Atorvastatin 40 mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Pitavastatin 4 mg QD intervention 2: Atorvastatin 40 mg | intervention 1: Pitavastatin intervention 2: Atorvastatin | 35 | Aalborg | N/A | Denmark | 9.9187 | 57.048
Vejle | N/A | Denmark | 9.5357 | 55.70927
Vejle | N/A | Denmark | 9.5357 | 55.70927
Berlin-Spandau | N/A | Germany | N/A | N/A
Chemnitz | N/A | Germany | 12.92922 | 50.8357
Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552
Mainz | N/A | Germany | 8.2791 | 49.98419
Messkirc... | 0 | NCT00344370 |
[
2
] | 37 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Non-randomized, open, dose ranging and dose scheduling study of ascending doses of KW-2449 in subjects with AML, ALL, MDS and CML. | This is a Phase I open-label dose escalation study of KW-2449 in subjects with acute leukemias, high risk MDS, and CML who are not candidates for approved therapy. Over an 18-month period, the investigative sites collectively will enroll up to a total of 96 subjects. Subjects will be enrolled sequentially into 1 of 7 d... | Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Myelogenous Leukemia | AML ALL MDS CML Kinase Inhibitor | null | 1 | arm 1: Treatment with ascending doses of KW-2449 | [
0
] | 1 | [
0
] | intervention 1: Sequential ascending oral doses of KW-2449 given for 14 or 28 days (modified by protocol amendment to only 14 days dosing). | intervention 1: KW-2449 | 4 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Princeton | New Jersey | United States | -74.65905 | 40.34872
New York | New York | United States | -74.00597 | 40.71427
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00346632 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with rad... | OBJECTIVES:
Primary
* Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy.
Secondary
* Determine the progression-free, disease-f... | Head and Neck Cancer | oral complications of radiation therapy oral complications of chemotherapy mucositis xerostomia stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage III squamous cell ... | null | 1 | arm 1: Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol. | [
0
] | 7 | [
2,
2,
0,
0,
0,
3,
4
] | intervention 1: subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses. intervention 2: If applicable on day 5, repeating every 3 weeks for 2 courses. intervention 3: Intravenous over 1 hour on day 1, every 3 weeks for 3 courses. intervention 4: Intravenous over 1 hour on day 1. intervention 5: Intravenous ... | intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: cisplatin intervention 4: docetaxel intervention 5: fluorouracil intervention 6: conventional surgery intervention 7: radiation therapy | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00352118 |
[
2
] | 36 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatmen... | null | Colorectal Cancer | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 7.5mg/kg iv (cycle 3 only) intervention 2: 130mg/m2 iv (cycles 1, 2 and 3) intervention 3: 1000mg/m2 po bid (cycles 1, 2 and 3) | intervention 1: Avastin intervention 2: Oxaliplatin intervention 3: capecitabine [Xeloda] | 3 | Hamilton | Ontario | Canada | -79.84963 | 43.25011
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT00353262 | |
[
5
] | 349 | null | PARALLEL | 0TREATMENT | null | false | 0ALL | null | The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients curr... | null | Pulmonary Disease, Chronic Obstructive | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: tiotropium intervention 2: Combivent (Ipratropium/Albuterol) | 31 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Long Beach | California | United States | -118.18923 | 33.76696
Palo Alto | California | United States | -122.14302 | 37.44188
Fort Collins | Col... | 0 | NCT00359788 | |
[
4
] | 1,385 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group. | null | Sexual Dysfunctions, Psychological | null | 4 | arm 1: 25 mg twice daily for 24 weeks arm 2: 50 mg taken once daily at bedtime for 24 weeks arm 3: 50 mg twice daily for 24 weeks arm 4: twice daily for 24 weeks | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Experimental: flibanserin 25 mg b.i.d intervention 2: Experimental: flibanserin 50mg qhs intervention 3: Experimental: flibanserin 50mg b.i.d. intervention 4: placebo | intervention 1: flibanserin intervention 2: flibanserin intervention 3: flibanserin intervention 4: placebo | 81 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Mobile | Alabama | United States | -88.04305 | 30.69436
Tucson | Arizona | United States | -110.92648 | 32.22174
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Carmichael | California | United States | -121.32828 | 38.61713
Redding | California | Un... | 0 | NCT00360243 | |
[
4
] | 723 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Randomised, double-blind, double dummy, parallel group design. Following the screening period patients will be randomised at the baseline visit, in a 1:1:1 manner, to one of three treatment arms; 4 mg E2007, 200 mg entacapone (with each dose of levodopa) or placebo. The first 4 weeks of the double blind phase will be u... | null | Parkinson's Disease | null | 3 | arm 1: matching E2007 and matching entacapone arm 2: 2 mg once daily in the evening, Weeks 0→2 (2 weeks) and 4 mg once daily in the evening, Weeks 2→18. arm 3: 200 mg with each dose of Levodopa. | [
2,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Placebo intervention 2: E2007 intervention 3: E2007 | 1 | Toulouse | N/A | France | 1.44367 | 43.60426 | 0 | NCT00360308 | |
[
4
] | 997 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase, lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56). All patients will receive active study drug. ... | null | Parkinson's Disease | null | 1 | arm 1: During the first two weeks of the study, Patients received 1 x 2mg E2007 tablet. At the week 2 visit, patients who tolerated the 2 mg/day dose were up-titrated to receive 4mg/day (2 x 2 mg E2007 tablets). Patients not tolerating the 4 mg dose were allowed to down titrate to 2 mg. Patients who did not tolerate th... | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: E2007 | 1 | Marburg | N/A | Germany | 8.77069 | 50.80904 | 0 | NCT00360412 | |
[
4
] | 880 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group. | This trial was designed as a prospective, multicenter trial containing a 24-week, randomized, double blind, placebo controlled, parallel-group period that assessed the effects of flibanserin (maximum total daily dose: 100 mg q.d.) compared with placebo in premenopausal women with HSDD, determined by Diagnostic and Stat... | Sexual Dysfunctions, Psychological | null | 3 | arm 1: flibanserin 50 mg q.h.s. arm 2: flibanserin 100 mg q.h.s. arm 3: placebo q.h.s. | [
0,
0,
2
] | 1 | [
0
] | intervention 1: flibanserin placebo versus 50 mg qhs versus 100 mg qhs | intervention 1: flibanserin | 54 | Mobile | Alabama | United States | -88.04305 | 30.69436
South Birmingham | Alabama | United States | N/A | N/A
Phoenix | Arizona | United States | -112.07404 | 33.44838
La Mesa | California | United States | -117.02308 | 32.76783
San Diego | California | United States | -117.16472 | 32.71571
Westlake Village | Californ... | 0 | NCT00360529 | |
[
0
] | 35 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone mass after two years of treatment with Forteo, in postmenopausal women. | This will be a single center open label proof of concept study, recruiting subjects previously treated with Forteo for at least 12 months.
A screening period of 3 to 6 weeks will precede the treatment period. At the baseline visit, patients whose eligibility is confirmed will be treated with ZA and followed for 12 mon... | Osteoporosis | osteoporosis zoledronic acid forteo | null | 1 | arm 1: 5 mg zoledronic acid in a single 15 minute IV | [
0
] | 1 | [
0
] | intervention 1: 5 mg zoledronic acid administered in a single 15 minute IV | intervention 1: zoledronic acid | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00361595 |
[
3
] | 35 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a phase 2 open-label, multicenter, non-randomized study to evaluate the safety and efficacy of oral pazopanib as neoadjuvant treatment for patients with stage 1A, 1B, IIA or IIB (to T2) resectable Non-Small Cell Lung Cancer (NSCLC). | null | Non-Small Cell Lung Cancer Lung Cancer, Non-Small Cell | pazopanib I-ELCAP non-small cell lung cancer antiangiogenesis NSCLC GW786034 | null | 1 | arm 1: 800 mg pazopanib oral daily | [
0
] | 1 | [
0
] | intervention 1: Pazopanib is an oral, potent, multi-target receptor tyrosine kinase inhibitor of VEGFR-1, -2, -3, PDGFR-alpha and -beta and c-kit. Subjects were to receive 800 mg oral pazopanib daily for a minimum of 2 weeks to a maximum of 6 weeks. | intervention 1: Pazopanib | 12 | Duarte | California | United States | -117.97729 | 34.13945
Rancho Mirage | California | United States | -116.41279 | 33.73974
Aurora | Colorado | United States | -104.83192 | 39.72943
Newark | Delaware | United States | -75.74966 | 39.68372
Miami | Florida | United States | -80.19366 | 25.77427
Chicago | Illinois | Un... | 0 | NCT00367679 |
[
5
] | 28 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | null | The objective of this study is to show that Ezetimibe will improve endothelial function following high cholesterol meals in healthy subjects by decreasing absorption of cholesterol and thus affecting concentration and composition of remnant-like particles. | 24 subjects will be recruited. Exclusion criteria will be presence of known metabolic syndrome as well as history of coronary artery disease, hypertension, diabetes, cardiomyopathy and tobacco use. Study will be conducted as double blind placebo controlled crossover trial. Subjects will be randomized to 2 groups. 1st g... | Endothelial Dysfunction | null | 2 | arm 1: 1st group will receive Ezetimibe for 2 weeks followed by washout (no medication) period for 4 weeks and followed by placebo for 2 weeks. arm 2: 2nd group will receive Ezetimibe and placebo in reverse order with interspaced 4-week washout period. | [
5,
5
] | 1 | [
0
] | intervention 1: None | intervention 1: Ezetimibe | 0 | null | 0 | NCT00376246 | |
[
3
] | 96 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The trial will be performed to evaluate whether BI 2536 may be effective in the treatment of advanced or metastatic NSCLC of stage IIIB or IV in patients who relapsed after or failed first-line therapy. A secondary aim is to identify the most suitable dosage schedule for the further Phase II and III clinical programme ... | null | Carcinoma, Non-Small-Cell Lung | null | 3 | arm 1: Day 1 arm 2: Day 1, 2, and 3 arm 3: Day 1, 2, and 3 | [
0,
0,
0
] | 1 | [
0
] | intervention 1: Intravenous Infusion | intervention 1: BI 2536 | 7 | Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959
Gauting | N/A | Germany | 11.37703 | 48.06919
Großhansdorf | N/A | Germany | 10.28333 | 53.66667
Heidelberg | N/A | Germany | 8.69079 | 49.40768
Mainz | N/A | Germany | 8.2791 | 49.98419
Mainz | N/A | Germany | 8.2791 | 49.98419
Wiesbaden | N/A | Germany | 8.2493... | 0 | NCT00376623 | |
[
5
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt | Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)-it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a me... | Glaucoma | glaucoma diurnal intraocular pressure | null | 1 | arm 1: Cosopt twice daily in both eyes | [
1
] | 1 | [
0
] | intervention 1: Cosopt twice daily in both eyes | intervention 1: Cosopt | 0 | null | 0 | NCT00379834 |
[
4
] | 450 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder.
PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The... | null | Anxiety Disorders | Generalised Anxiety Disorder GAD | null | 2 | arm 1: Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily. arm 2: Matching placebo tablets orally administered once daily. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period. intervention 2: Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment perio... | intervention 1: Quetiapine XR intervention 2: Placebo | 43 | Fort Myers | Florida | United States | -81.84059 | 26.62168
Gainsville | Florida | United States | N/A | N/A
Miami | Florida | United States | -80.19366 | 25.77427
Sarasota | Florida | United States | -82.53065 | 27.33643
Roswell | Georgia | United States | -84.36159 | 34.02316
Boston | Massachusetts | United States | ... | 0 | NCT00389064 |
[
4
] | 556 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg). | null | Hypertension | Hypertension, aliskiren, amlodipine, HCTZ, blood pressure | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration intervention 2: All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration intervention 3: Opt... | intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide | 8 | Santa Fe | New Mexico | United States | -105.9378 | 35.68698
Investigative Site | N/A | Belgium | N/A | N/A
Investigative Center | N/A | Denmark | N/A | N/A
Investigative Site | N/A | Finland | N/A | N/A
Investigative Center | N/A | Germany | N/A | N/A
Investigative Site | N/A | Iceland | N/A | N/A
Investigative Site |... | 0 | NCT00402103 |
[
5
] | 80 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of long term (up to 3 years) adefovir dipivoxil 10mg t... | null | Hepatitis B, Chronic Chronic Hepatitis B | Adefovir Dipivoxil(Hepsera) Chronic Hepatitis B (CHB) | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: adefovir dipivoxil 10mg | 1 | Seoul | N/A | South Korea | 126.9784 | 37.566 | 0 | NCT00403585 |
[
4
] | 716 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis who meet the criteria for persistent allergic rhinitis (PER) | null | Allergic Rhinitis | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 5-mg Desloratadine tablet, once daily for 12 weeks intervention 2: Placebo tablet, once daily for 12 weeks | intervention 1: 5-mg Desloratadine intervention 2: Placebo tablet | 0 | null | 0 | NCT00405964 | |
[
5
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successf... | Retinal venous occlusive disease, which includes central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), is second only to diabetic retinopathy as a cause of vision loss due to retinal disease. The main cause of vision loss in all of these disorders is the development of macular edema. Current c... | Branch Retinal Vein Occlusion | branch retinal vein occlusion macular edema pegaptanib sodium vascular endothelial growth factor | null | 2 | arm 1: Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54. arm 2: Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly i... | [
1,
1
] | 1 | [
0
] | intervention 1: Subjects were randomized 3:1 to intravitreous injections of pegaptanib 0.3mg or 1mg at baseline and at weeks 6 and 12 with subsequent injections at 6-week intervals at investigator discretion until week 48. | intervention 1: pegaptanib sodium (Macugen) | 3 | Los Angeles | California | United States | -118.24368 | 34.05223
Hagerstown | Maryland | United States | -77.71999 | 39.64176
West Columbia | South Carolina | United States | -81.07398 | 33.99349 | 0 | NCT00406107 |
[
5
] | 245 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Co... | null | Dyslipidemia Hypertension | null | 4 | arm 1: Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks. arm 2: Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo. arm 3: Blinded amlodipine 19 mg and amlodipine/ator... | [
1,
0,
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Amlodipine besylate 5 mg intervention 2: Amlodipine/atorvastatin single pill combination 10/20 mg intervention 3: Amlodipine besylate 10 mg intervention 4: Amlodipine/atorvastatin single pill combination 5/20 mg | intervention 1: Amlodipine besylate intervention 2: Amlodipine besylate/atorvastatin calcium single pill combination intervention 3: Amlodipine besylate intervention 4: Amlodipine besylate/atorvastatin calcium single pill combination | 51 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Mesa | Arizona | United States | -111.82264 | 33.42227
Garden Grove | California | United States | -117.94145 | 33.77391
Mission Viejo | Cal... | 0 | NCT00412113 | |
[
2,
3
] | 8 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC. | Outline: This is a multi-center study.
Chemotherapy/radiation therapy (2 cycles)
* Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle
* Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle
* Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 c... | Non-Small Cell Lung Cancer | null | 1 | arm 1: Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer | [
0
] | 4 | [
0,
0,
3,
0
] | intervention 1: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle intervention 2: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle intervention 3: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) intervention 4: Maintenance therapy... | intervention 1: Cisplatin intervention 2: Etoposide intervention 3: Radiotherapy intervention 4: Sorafenib | 8 | Galesburg | Illinois | United States | -90.37124 | 40.94782
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Goshen | Indiana | United States | -85.83444 | 41.58227
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Lafayette | Indiana | United States | -86.87529 | 40.4167
Muncie | Indiana | United... | 0 | NCT00417248 | |
[
3
] | 10 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will determine whether an experimental drug called Rilonacept can improve artery function in patients with atherosclerosis, a disease in which fatty deposits in arteries cause the vessels to stiffen, impeding blood flow. Atherosclerosis is believed to be caused in part by inflammation. Rilonacept blocks prod... | Rilonacept (Interleukin-1 Trap) has been developed as an antagonist of the cytokine IL-1 in the treatment of rheumatoid arthritis and other inflammatory diseases. IL-1 causes leukocyte accumulation by inducing adhesion receptors on vascular endothelium and stimulating chemokine production. It also stimulates the synthe... | Coronary Artery Disease Atherosclerosis Inflammation Endothelial Dysfunction | Endothelium Inflammation Nitric Oxide Rilonacept Cytokines Coronary Artery Disease CAD Atherosclerosis | null | 2 | arm 1: Rilonacept 320 mg subcutaneous at each treatment visit arm 2: Normal saline subcutaneously at each treatment visit. | [
0,
3
] | 2 | [
0,
0
] | intervention 1: Lyophilized rilonacept will be supplied by Regeneron Pharmaceuticals at 160 mg/vial and reconstituted with 2.3 mL of sterile water for injection by the Clinical Center Pharmacy Intravenous Admixture Unit. The formulation contains 80 mg/mL rilonacept, histidine, citrate, PEG 3350, polysorbate 20, glycine... | intervention 1: Rilonacept intervention 2: Placebo | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00417417 |
[
4
] | 52 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining remission and renal function in patients with lupus nephritis. Patients will be randomized to rece... | null | Lupus Nephritis | null | 2 | arm 1: Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID from Weeks 32 to 48. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, on... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48 intervention 2: 0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction ... | intervention 1: Mycophenolate Mofetil intervention 2: Corticosteroids intervention 3: Azathioprine intervention 4: Cyclophosphamide | 11 | 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
Guangzhou | N/A | China | 113.25 | 23.11667
Hangzhou | N/A | China | 120.16142 | 30.29365
Nanjing | N/A | China | 118.77778 | 32.06167
Shanghai ... | 0 | NCT00425438 | |
[
3
] | 25 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Phase IIb open-label extension study for patients with Parkinson's Disease. All patients will receive active study drug. The study will involve outpatient visits only. Patients who completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria will be enrolled and enter the 12-week Titratio... | null | Parkinson's Disease | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime. | intervention 1: E2007 | 9 | Peoria | Arizona | United States | -112.23738 | 33.5806
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Oxnard | California | United States | -119.17705 | 34.1975
Boca Raton | Florida | United States | -80.0831 | 26.35869
Delray Beach | Florida | United States | -80.07282 | 26.46146
Port Charlotte | Flori... | 0 | NCT00427011 | |
[
4
] | 274 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 2MALE | null | Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men | null | Hypogonadism | Hypogonadism Testosterone Deficiency | null | 2 | arm 1: Placebo arm 2: Testosterone (T) gel 1.62% | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient. intervention 2: Placebo Control | intervention 1: Testosterone (T) Gel 1.62% intervention 2: Placebo | 0 | null | 0 | NCT00433199 |
[
3
] | 91 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study was to determine the dose ranges of peginesatide administered intravenously or subcutaneously that maintained hemoglobin in participants on dialysis whose hemoglobin values were stable on epoetin (alfa or beta). | Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. Th... | Anemia Chronic Kidney Disease Chronic Renal Failure | anemia chronic kidney disease CKD chronic renal failure CRF dialysis erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemodialysis hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production | 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: Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a ... | intervention 1: peginesatide intervention 2: peginesatide intervention 3: peginesatide intervention 4: peginesatide intervention 5: peginesatide intervention 6: peginesatide | 15 | Burgas | N/A | Bulgaria | 27.46781 | 42.50606
Pleven | N/A | Bulgaria | 24.61667 | 43.41667
Plovdiv | N/A | Bulgaria | 24.75 | 42.15
Rousse | N/A | Bulgaria | 25.9534 | 43.84872
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Varna |... | 0 | NCT00434330 |
[
3
] | 17 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | Primary Objectives:
* To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer
* To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing
Secondary objectives:
* To evaluate the efficacy of glufosfamid... | Open-label, multicenter, Phase 2 dose escalation study. Subjects will be randomized to receive either once every three weeks dosing regimen or the weekly dosing regimen. Randomization will utilize a 2:1 ratio with two-thirds of the subjects randomized to the weekly dosing regimen.
In the weekly dosing schedule, treatm... | Ovarian Cancer | Ovarian Cancer CA-125 Third-line Glufosfamide | null | 3 | arm 1: 1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle arm 2: 1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle arm 3: 1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle | [
0,
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Glufosfamide | 10 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Tucson | Arizona | United States | -110.92648 | 32.22174
Greenbrae | California | United States | -122.5247 | 37.94854
Orange | California | United States | -117.85311 | 33.78779
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Louisville | Kentu... | 0 | NCT00442598 |
[
5
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Because ziprasidone has not been extensively studied and is not widely accepted in the severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who need a change of medication because of ineffe... | Ziprasidone has been found in studies and practice to be efficacious and tolerated well but has not been well studied or well accepted in the very severely ill in State Hospitals. This study aims to fill that gap by examining 75 patients with schizophrenia or schizoaffective disorder who require a change of medication ... | Schizophrenia Schizoaffective Disorder | Schizophrenia Ziprasidone | null | 1 | arm 1: Open label change to ziprasidone | [
0
] | 1 | [
0
] | intervention 1: Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks | intervention 1: ziprasidone | 2 | Buffalo | New York | United States | -78.87837 | 42.88645
The Bronx | New York | United States | -73.86641 | 40.84985 | 0 | NCT00458211 |
[
5
] | 30 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inhaler (MDI). The administration of the study medication will be as follows: three single doses, separated by a wash-out pe... | null | Allergic Rhinitis | Allergic rhinitis | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
1,
1
] | 1 | [
0
] | intervention 1: None | intervention 1: Ciclesonide | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 0 | NCT00458835 |
[
3
] | 420 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C. | null | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome with Constipation IBS Irritable Bowel Syndrome linaclotide acetate linaclotide MD-1100 | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
1,
1,
1,
1,
2
] | 2 | [
0,
0
] | intervention 1: Oral, once daily intervention 2: Oral, once daily | intervention 1: Linaclotide Acetate intervention 2: Matching placebo | 85 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Chandler | Arizona | United States | -111.84125 | 33.30616
Tuscon | Arizona | United States | N/A | N/A
Sherwood | Arkansas | United States | -92.22432 | 34.81509
Anaheim | California | United States | -117.9145 | 33.83529
Garden Grove | California | United Sta... | 0 | NCT00460811 |
[
5
] | 112 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on... | null | Type 2 Diabetes Mellitus | Symlin Amylin insulin Humalog Novolog Apidra | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals intervention 2: subcutaneous injection, dosing based on titration guidelines intervention 3: subcutaneous injection, dosing based on titration guidelines | intervention 1: pramlintide acetate (Symlin) intervention 2: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) intervention 3: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) | 37 | Northport | Alabama | United States | -87.57723 | 33.22901
Phoenix | Arizona | United States | -112.07404 | 33.44838
Loma Linda | California | United States | -117.26115 | 34.04835
Aurora | Colorado | United States | -104.83192 | 39.72943
Hollywood | Florida | United States | -80.14949 | 26.0112
Maitland | Florida | Un... | 0 | NCT00467649 |
[
2
] | 140 | NON_RANDOMIZED | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional imag... | Please note that the present study is allocated two study phases, i.e. phase I and phase III. | Magnetic Resonance Imaging | Contrast-enhanced MRI MR angiography (MRA) Children 2-17 years | null | 4 | arm 1: Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection arm 2: Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection arm 3: Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 m... | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection | intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) | 14 | Vienna | Vienna | Austria | 16.37208 | 48.20849
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Toronto | Ontario | Canada | -79.39864 | 43.70643
Erlangen | Bavaria | Germany | 11.00783 | 49.59099
Bonn | North Rhine-Westphalia | Germany | 7.09549 | 50.73438
Dresden | Saxony | Germany | 13.73832 | 51.05089
Leipzig |... | 0 | NCT00468819 |
[
5
] | 480 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Africa, Asia, Europe, Oceania and South America.
This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes. | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. intervention 2: Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. intervention 3: Ta... | intervention 1: biphasic insulin aspart intervention 2: insulin glargine intervention 3: metformin intervention 4: glimepiride | 69 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Ciudad Autonoma de Bs As | N/A | Argentina | N/A | N/A
Ciudad Autónoma de BsAs | N/A | Argentina | N/A | N/A
Mar del Plata | N/A | Argentina | -57.5562 | -38.00042
Bregenz | N/A | Austria | 9.7471 | 47.50311
Feldkirch | N/A | Austria | 9.6 | 47.23306
Traisen | N/A ... | 0 | NCT00469092 | |
[
3
] | 226 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain. | This is a phase II, multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with chronic pain in the lower extremities due to diabetic peripheral neuropathy (DPN). | Diabetic Peripheral Neuropathy Neuralgia | DPN Diabetic Nerve Pain | null | 2 | arm 1: vehicle cream arm 2: active topical cream | [
2,
1
] | 2 | [
0,
0
] | intervention 1: topical cream applied daily for 4 weeks intervention 2: inactive placebo cream applied two times daily | intervention 1: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream intervention 2: placebo cream | 1 | New Delhi | N/A | India | 77.2148 | 28.62137 | 0 | NCT00476151 |
[
3
] | 49 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with panic disorder. This study will provide an initial assessment of efficacy, and to continue to describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato Alprazolam on a doxapram-induced panic attack in pa... | The study will be conducted at multiple centers. A total of 42 male and female panic disorder patients will be studied. The first 6 subjects will receive Staccato Alprazolam 1 mg open label to validate the dose selection. The remaining 36 subjects will be treated with either Staccato Alprazolam at the chosen dose; or w... | Treatment of Induced Panic Attack | Staccato™ Alprazolam, Panic Attack, Inhaled alprazolam | null | 4 | arm 1: Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial arm 2: Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial arm 3: Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV... | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Inhaled Staccato Alprazolam Placebo intervention 2: Inhaled Staccato Alprazolam 1 mg intervention 3: Inhaled Staccato Alprazolam 2 mg intervention 4: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo | intervention 1: Inhaled placebo intervention 2: Inhaled alprazolam 1 mg intervention 3: Inhaled alprazolam 2 mg intervention 4: IV doxapram | 3 | Brooklyn | New York | United States | -73.94958 | 40.6501
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00477451 |
[
4
] | 854 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | false | The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy. | Subjects undergoing abdominal hysterectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction... | Hysterectomy Postoperative | Opioid Central acting analgesic Pain postoperative Abdomen acute CG5503 IR Morphine Placebo | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
1,
0,
0,
0,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 20 mg IR; 4 - 6 hourly; Total 72 hours intervention 2: 50mg; 4 - 6 hourly; Total 72 hours intervention 3: 75mg; 4 -6 hourly; Total 72 hours intervention 4: 100mg, 4 - 6 hourly; Total 72 hours intervention 5: 4 - 6 hourly; Total 72 hours | intervention 1: Morphine intervention 2: CG5503 IR intervention 3: CG5503 IR intervention 4: CG5503 IR intervention 5: Placebo | 52 | Békéscsaba | N/A | Hungary | 21.1 | 46.68333
Debrecen | N/A | Hungary | 21.62444 | 47.53167
Komárom | N/A | Hungary | 18.11913 | 47.74318
Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539
Riga | N/A | Latvia | 24.10589 | 56.946
Riga | N/A | Latvia | 24.10589 | 56.946
Riga | N/A | Latvia | 24.10589 | 56.946
Riga | N/A |... | 0 | NCT00478023 |
[
2,
3
] | 6 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study will test whether botulinum toxin (Botox) may relieve the uncomfortable sensations patients with restless legs syndrome (RLS) experience. RLS is a common movement disorder that causes sensory discomfort and restlessness, most often in the legs, which improves with movement. Although medications are available... | OBJECTIVE:
To evaluate the efficacy of botulinum toxin type A, (BoNT) for the treatment of primary Restless legs syndrome (RLS). We hypothesize that BoNT will be effective at decreasing the deep sensory discomfort of RLS.
STUDY POPULATION:
This protocol is a proof of principle double-blind randomized placebo-BoNT cr... | Restless Legs Syndrome | Restless Leg Syndrome Botulinum Toxin RLS | null | 2 | arm 1: Injection of onabotulinumtoxinA arm 2: Injection of saline placebo | [
0,
2
] | 1 | [
0
] | intervention 1: Maximum dose of 90 units/leg was injected. | intervention 1: Botulinum Toxin A | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00479154 |
[
3
] | 16 | RANDOMIZED | CROSSOVER | 4SUPPORTIVE_CARE | 1SINGLE | false | 0ALL | null | Commercially available external photoprotectors (EP) do not provide adequate protection against ultraviolet A (UVA) and visible wavelengths. The proposed medicinal product V0096 CR (formula RV3131A-MV1166) is a broad spectrum EP (bsEP). The rationale for the use of V0096 CR (formula RV3131A-MV1166) in the proposed cond... | null | Idiopathic Solar Urticaria | null | 1 | arm 1: Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
Single application of the test materials at the dosage of 2mg/cm² (total of 8 treated sites), prior to irradiation using a solar simulator. | [
0
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
0
] | 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 1: Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209) intervention 2: Ti02 pigmentary 3% alone (formula RV3131A-MV1211) intervention 3: bisoctrizole 10% alone (formula RV3131A-MV1237) intervention 4: Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213) intervention 5: Ti... | 3 | Detroit | Michigan | United States | -83.04575 | 42.33143
New York | New York | United States | -74.00597 | 40.71427
Dundee | N/A | United Kingdom | -2.97489 | 56.46913 | 0 | NCT00483496 | |
[
5
] | 7 | RANDOMIZED | CROSSOVER | 4SUPPORTIVE_CARE | 3TRIPLE | true | 0ALL | false | This is a small study known as a pilot study. This pilot study is being done to see if a difference in pain from intramuscular palivizumab injection can be detected if tetracaine a topical numbing gel is used compared to no medication (placebo). If a difference is found in this pilot study, then a larger study may be d... | Objective:
1\) To determine if tetracaine 4% gel (Ametop ®) reduces the pain of intramuscular palivizumab compared to placebo for pediatric patients between 1 month and 2 years of age.
Rationale:
Premedication with a systemic analgesic has not been shown to be effective in reducing the pain from an acute localized i... | Pain | null | 2 | arm 1: Tetracaine 4% gel 1g applied to injection site arm 2: Placebo cream (Aquatain) 1g applied to inejction site | [
0,
2
] | 2 | [
0,
0
] | intervention 1: tetracaine applied prior to 1 injection intervention 2: placebo applied prior to 1 injection | intervention 1: tetracaine 4% gel intervention 2: Placebo | 1 | Surrey | British Columbia | Canada | -122.82509 | 49.10635 | 0 | NCT00484393 | |
[
3
] | 210 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults. | null | Type 2 Diabetes Mellitus | Diabetes, Obese diabetics | null | 2 | arm 1: Phentermine 15mg/topiramate 100mg arm 2: Matched placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: phentermine 15mg/topiramate 100mg intervention 2: matched placebo | intervention 1: VI-0521 intervention 2: Placebo | 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 | NCT00486291 |
[
5
] | 47 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression. | This study consisted of two phases. In the Induction phase patients were randomized at Baseline 1 (BL1) in a 1:2 ratio to receive:
* I1: HAART or
* I2: Enfuvirtide (90 mg twice a day) + HAART.
Participants who achieved viral suppression \< 50 copies/mL by week 24, confirmed by week 28 or earlier, qualified to enter t... | HIV Infections | null | 2 | arm 1: Participants received Enfuvirtide (ENF) 90 mg administered by subcutaneous injection twice a day for up to 48 weeks in addition to an oral highly active antiretroviral treatment (HAART) regimen for up to 48 weeks. arm 2: Participants received an oral highly active antiretroviral treatment (HAART) regimen, consis... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 90 mg subcutaneous injection twice a day intervention 2: An oral HAART regimen of 3-5 antiretrovirals was chosen by the physician and patient, based on the patient's prior treatment history and genotypic antiretroviral resistance testing. | intervention 1: Enfuvirtide intervention 2: Highly active antiretroviral treatment (HAART) | 39 | Cleveland | Ohio | United States | -81.69541 | 41.4995
Austin | Texas | United States | -97.74306 | 30.26715
Dallas | Texas | United States | -96.80667 | 32.78306
Vancouver | British Columbia | Canada | -123.11934 | 49.24966
Le Kremlin-Bicêtre | N/A | France | 2.36073 | 48.81471
Nantes | N/A | France | -1.55336 | 47.21... | 0 | NCT00487188 | |
[
5
] | 82 | RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | true | Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative cystoid macular edema following uncomplicated cataract surgery
Participants: Patients having cataract surgery at UNC who meet eligibility criteria
Procedures (methods): Patients will have pre and post-operative vision measured... | We plan to enroll 80 patients in this prospective randomized clinical trial. Eligible patients will be randomized into two groups. All patients will have pre-operative Early Treatment of Diabetic Retinopathy Study (ETDRS) vision measured and pre-operative OCT (Humphrey-Zeiss Medical Systems, San Leandro, CA) in both ey... | Cystoid Macular Edema | cystoid macular edema cataract nonsteroidal antiinflammatory drugs optical coherence tomography | null | 2 | arm 1: topical antibiotic for 10 days and a topical corticosteroid for 1 month arm 2: 1 drop per study eye three times per day for 30 days in addition to standard care | [
1,
0
] | 2 | [
0,
0
] | intervention 1: topical antibiotic for 10 days plus topical corticosteroids for 1 month intervention 2: liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid | intervention 1: Standard Care intervention 2: nepafenac | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00494494 |
[
4
] | 328 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a multicentre, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or E2007-G000-309 will be candidates for entering this ext... | null | Parkinson's Disease | null | 1 | arm 1: E2007 2 mg (one 2 mg tablet taken daily in the evening), or 4 mg (two 2 mg tablets daily in the evening). | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Perampanel | 1 | Toulouse | Toulouse Cedex | France | 1.44367 | 43.60426 | 0 | NCT00505622 | |
[
3
] | 7 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Objective
The objective of this study is to discover whether an infusion of nicardipine is able to reduce the time taken to achieve electrocerebral silence (ECS) during cardiopulmonary bypass (CPB) for aortic surgery.
Hypothesis
By inhibiting cold-induced cerebral vasoconstriction, nicardipine will maintain cerebral... | Patients undergoing thoracic aortic surgery at Duke University Medical Center (DUMC) requiring hypothermic circulatory arrest (HCA) and neurophysiologic monitoring (NIOM) will give written informed consent and be enrolled into the study. Exclusion criteria will include previously documented allergy to nicardipine and a... | Aortic Aneurysm, Thoracic | Aortic Arch Reconstruction Surgery | null | 2 | arm 1: Nicardipine arm 2: 0.9% saline | [
0,
2
] | 2 | [
0,
0
] | intervention 1: on bypass intervention 2: on bypass | intervention 1: Nicardipine intervention 2: 0.9% saline | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00508118 |
[
3,
4
] | 58 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | false | This purpose of this study is to investigate whether the number and size of rectal polyps can be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified form of a naturally occurring substance, the omega-3 fatty acid, eicosapentaenoic acid (EPA). | It has been found that people who consume a large amount of oily fish tend to have a lower risk of developing colon cancer. This is thought to be due to the omega-3 fatty acids present in oily fish, one of which is EPA. The effect of taking a 99% pure form of EPA (2g per day) compared with placebo capsules on the numbe... | Familial Adenomatous Polyposis Coli FAP | Eicosapentaenoic Acid EPA EPA 99% Fatty acid omega-3 apoptosis cell proliferation colonic mucosa polyp Familial Adenomatous Polyposis Coli FAP resolvin Ileo-rectal anastomosis IRA PUFA Endoscopy | null | 2 | arm 1: Eicosapentanenoic Acid (EPA) as the free fatty acid 2 capsules twice daily for 6 months.
Endoscopy and biopsies taken as described under intervention. arm 2: Medium chain triglycerides 2 capsules twice daily for six months. Endoscopy and biopsies taken as described under intervention. | [
0,
2
] | 4 | [
0,
3,
3,
0
] | intervention 1: 2 x 500mg EPA capsules twice daily for 6 months intervention 2: Endoscopy with video and photographs at baseline and month 6. intervention 3: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatt... | intervention 1: Eicosapentanoic Acid (EPA) intervention 2: Endoscopy intervention 3: Biopsies taken intervention 4: Placebo | 1 | Harrow | Middlesex | United Kingdom | -0.33208 | 51.57835 | 0 | NCT00510692 |
[
4
] | 2,152 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 1FEMALE | false | The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years. | null | Contraception | null | 2 | arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2
monophasic combined oral contraceptive arm 2: Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive | [
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 13 consecutive 28-day menstrual cycles (1 year). intervention 2: Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from... | intervention 1: NOMAC-E2 intervention 2: DRSP-EE | 0 | null | 0 | NCT00511199 | |
[
2
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin. | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose \[TD\] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments.
Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was give... | intervention 1: MK-0941 intervention 2: Placebo intervention 3: LANTUS insulin | 0 | null | 0 | NCT00511472 | |
[
2
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit cont... | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day intervention 2: Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day | intervention 1: MK0941 intervention 2: Comparator: Placebo | 0 | null | 0 | NCT00511667 | |
[
4
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a Phase III, multicenter, open-label study, that will evaluate the improvement of nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by Aptalis (formerly Axcan). This study is performed in children from 7 to 11 years old. | This is a Phase III, multicenter, open-label study, which will quantify the improvement of nutrient absorption when participants are receiving Ultrase® MT20. The improvement will be demonstrated by comparing the CFA percent (%) and CNA% obtained during a washout of enzyme with the CFA% and CNA% obtained during a period... | Cystic Fibrosis Pancreatic Insufficiency | Cystic Fibrosis Pancreatic insufficiency Steatorrhea Children 7 to 11 years Pancreatic enzyme | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Ultrase® MT20 capsules will be administered orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants will receive high-fat diet and Ultrase® MT20 dose will be adjusted depending on symptoms of steatorrhea. This will be fo... | intervention 1: Ultrase® MT20 | 3 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Cleveland | Ohio | United States | -81.69541 | 41.4995
Hershey | Pennsylvania | United States | -76.65025 | 40.28592 | 0 | NCT00513682 |
[
4
] | 8 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This Phase 3, randomized, open-label, multicenter study in rheumatoid arthritis (RA) patients with low disease activity (Disease Activity Score 28 \[DAS28\] \>2.8 and \<3.5) is being conducted to evaluate induction of remission by adding infliximab to pre-existing treatment versus no additional treatment. All subjects ... | null | Rheumatoid Arthritis | null | 2 | arm 1: 3 mg/kg infliximab plus basic treatment arm 2: Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs \[DMARDs\]) | [
0,
1
] | 2 | [
2,
0
] | intervention 1: infliximab 3 mg/kg and basic treatment intervention 2: Methotrexate (15 - 25 mg/week); chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89 | intervention 1: infliximab intervention 2: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89. | 0 | null | 0 | NCT00521924 | |
[
4
] | 185 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects. | null | Hypertension | Hypertension Angiotensin Receptor Blocker Calcium Channel Blocker Stage I and II Hypertension | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: Tablets intervention 2: Tablets | intervention 1: Amlodipine intervention 2: Olmesartan medoxomil plus amlodipine | 18 | Buena Park | California | United States | -117.99812 | 33.86751
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
Tustin | California | United States | -117.82617 | 33.74585
West... | 0 | NCT00527514 |
[
3
] | 45 | null | FACTORIAL | 0TREATMENT | 0NONE | false | 0ALL | false | The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD | null | Attention Deficit Hyperactivity Disorder | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks | intervention 1: Atomoxetine | 12 | Aichi | N/A | Japan | 130.62158 | 32.51879
Chiba | N/A | Japan | 140.11667 | 35.6
Fukushima | N/A | Japan | 140.46667 | 37.75
Hokkaido | N/A | Japan | N/A | N/A
Hyōgo | N/A | Japan | 144.43333 | 43.36667
Ishikawa | N/A | Japan | 127.82139 | 26.42333
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Kumamoto | N/A | Japan |... | 0 | NCT00530335 | |
[
4
] | 165 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period | null | Hypertension Hypercholesterolemia | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
1,
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Single pill combination, dosed once daily for 8 weeks intervention 2: Single pill combination, dosed once daily for 8 weeks intervention 3: Single pill combination, dosed once daily for 8 weeks intervention 4: Single pill combination, dosed once daily for 8 weeks | intervention 1: Amlodipine 2.5mg/Atorvastatin 5mg intervention 2: Amlodipine 2.5mg/Atorvastatin 10mg intervention 3: Amlodipine 5mg/Atorvastatin 5mg intervention 4: Amlodipine 5mg/Atorvastatin 10mg | 17 | Fukuoka | Fukuoka | Japan | 130.41667 | 33.6
Kitakyushu-shi | Fukuoka | Japan | N/A | N/A
Kurume-shi | Fukuoka | Japan | N/A | N/A
Maebaru-shi | Fukuoka | Japan | N/A | N/A
Annaka | Gunma | Japan | 138.89585 | 36.33011
Sapporo | Hokkaido | Japan | 141.35 | 43.06667
Teine | Hokkaido | Japan | N/A | N/A
Yokohama | Kanaga... | 0 | NCT00530946 | |
[
4
] | 742 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks. | null | Bronchial Asthma | Asthma Symbicort | null | 3 | arm 1: Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily arm 2: Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily arm 3: Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily intervention 2: Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily intervention 3: Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily | intervention 1: Symbicort Turbuhaler intervention 2: Symbicort pMDI intervention 3: Pulmicort Turbuhaler | 48 | Pleven | N/A | Bulgaria | 24.61667 | 43.41667
Plovdiv | N/A | Bulgaria | 24.75 | 42.15
Rousse | N/A | Bulgaria | 25.9534 | 43.84872
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Varna | N/A | Bulgaria | 27.91667 | 43.21667
Benesov U Prahy | N/A | Czechia | N/A | N/A
Hradec Králové | N/A | Czechia | 15.83277 | 50.20923
J... | 0 | NCT00536731 |
[
3
] | 392 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device. | null | Asthma | QMF indacaterol Twisthaler® | null | 6 | arm 1: Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 2: Indacaterol 125 μg delivered by the TWISTHALER® devic... | [
0,
0,
0,
0,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device). intervention 2: Formoterol delivered by oral inhalation via AEROLIZER® inhalation device. intervention 3: Placebo TWISTHALER® device intervention 4: Placebo AEROLIZER® device intervention 5: 100 μg/ 90 μg salbutamol/albutero... | intervention 1: indacaterol intervention 2: formoterol intervention 3: placebo to indacaterol intervention 4: placebo to formoterol intervention 5: short acting β2-agonist | 60 | Aalst | N/A | Belgium | 4.0355 | 50.93604
Halen | N/A | Belgium | 5.11096 | 50.94837
Oostham | N/A | Belgium | 5.17877 | 51.10374
Veurne | N/A | Belgium | 2.66803 | 51.07316
Boskovice | N/A | Czechia | 16.65997 | 49.48751
Brno | N/A | Czechia | 16.60796 | 49.19522
Břeclav | N/A | Czechia | 16.88203 | 48.75897
Liberec |... | 0 | NCT00545272 |
[
3
] | 31 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma. | null | Asthma | Asthma, QMF149, fixed combination of indacaterol and mometasone furoate | null | 2 | arm 1: In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Tre... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device. intervention 2: Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device. intervention 3: Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® devi... | intervention 1: indacaterol maleate/mometasone furoate intervention 2: placebo to indacaterol maleate/mometasone furoate intervention 3: fluticasone proprionate / salmeterol xinafoate | 2 | Poitiers | N/A | France | 0.34348 | 46.58261
Berlin | N/A | Germany | 13.41053 | 52.52437 | 0 | NCT00556673 |
[
3
] | 37 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control. | null | Asthma | Asthma QMF Indacaterol Mometasone | null | 3 | arm 1: In Treatment Period 1 (Days 1 \& 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the followin... | [
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI. intervention 2: Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device. intervention 3: Placebo to indacaterol maleate/mometasone furoate delivered via the TWISTHALER device. interven... | intervention 1: fluticasone propionate/salmeterol intervention 2: indacaterol maleate / mometasone furoate intervention 3: placebo to indacaterol/mometasone intervention 4: placebo to fluticasone propionate/salmeterol | 6 | Aalst | N/A | Belgium | 4.0355 | 50.93604
Ghent | N/A | Belgium | 3.71667 | 51.05
Berlin | N/A | Germany | 13.41053 | 52.52437
Hanover | N/A | Germany | 9.73322 | 52.37052
Landsberg | N/A | Germany | 12.16076 | 51.52698
Rostock | N/A | Germany | 12.14049 | 54.0887 | 0 | NCT00557440 |
[
2
] | 78 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773 | null | Diabetes Mellitus, Type 2 | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: BI 10773 low dose intervention 2: placebo to BI 10773 intervention 3: BI 10773 medium dose intervention 4: BI 10773 high dose | 3 | Berlin | N/A | Germany | 13.41053 | 52.52437
Mainz | N/A | Germany | 8.2791 | 49.98419
Neuss | N/A | Germany | 6.68504 | 51.19807 | 0 | NCT00558571 | |
[
0
] | 28 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The goal of this placebo-controlled study is to provide preliminary efficacy data for potential pregnenolone effects on cognitive symptoms and negative symptoms in patients with schizophrenia. Depressive symptoms and positive symptoms... | See brief summary | Schizophrenia | Schizophrenia Pregnenolone Cognition Negative Symptoms | null | 2 | arm 1: Pregnenolone arm 2: Placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks intervention 2: Placebo (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID ... | intervention 1: Pregnenolone intervention 2: Placebo | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00560937 |
[
3
] | 12 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior therapy for their disease. A minimum of 12 and a ... | null | Primary Peritoneal Carcinoma Tumor Epithelial Ovarian Cancer Uterine Disease Cervix Diseases Neoplasms, Ovarian Cancer | AGO Advanced, Gynaecologic cancer(s), Genetics GW786034, Pazopanib, | null | 2 | arm 1: Oral Pazopanib 800 mg once a day+ carboplatin area under the concentration-time curve (AUC) 5 intravenous (IV) over 1 hour every 3 weeks + paclitaxel 175 mg/m\^2 IV over three hours day one q 3 weeks for six cycles arm 2: Oral Pazopanib 800 mg once a day+ carboplatin AUC 6 IV over 1 hour every 3 weeks + paclitax... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 800 mg orally once a day for 6 cycles intervention 2: IV over one hour every 3 weeks of 6 cycles intervention 3: IV 175 mg/m\^2 given over 3 hours on day one of a 21 day cycle for six cycles | intervention 1: pazopanib (GW786034) intervention 2: carboplatin intervention 3: paclitaxel | 5 | Lyon | N/A | France | 4.84671 | 45.74846
Strasbourg | N/A | France | 7.74553 | 48.58392
Marburg | Hesse | Germany | 8.77069 | 50.80904
Wiesbaden | Hesse | Germany | 8.24932 | 50.08258
Essen | North Rhine-Westphalia | Germany | 7.01228 | 51.45657 | 0 | NCT00561795 |
[
2
] | 18 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) \& oral compressed tablet (OCT) formulations of MK-0941-009 \& to assess the effect of food on the OCT formulation. | null | Type 2 Diabetes Mellitus | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state intervention 2: single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal intervention 3: single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before ... | intervention 1: 10 mg MK-0941 DFC (fasted) intervention 2: 10 mg MK-0941 OCT (after meal) intervention 3: 10 mg MK-0941 OCT (before meal) intervention 4: 10 mg MK-0941 OCT (fasted) | 0 | null | 0 | NCT00567112 | |
[
3
] | 34 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The goal of this clinical research study is to learn if azacitidine can help to control MF. The safety of azacitidine in patients with Myelofibrosis (MF) will also be studied. | Azacitidine is a drug that is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
If you are found to be eligible to take part in this study, you will be able to begin treatment ... | Myelofibrosis | Myelofibrosis MF Leukemia Azacitidine Vidaza | null | 1 | arm 1: 75 mg/m\^2 Subcutaneous Daily for 7 days every 4 weeks | [
0
] | 1 | [
0
] | intervention 1: 75 mg/m\^2 subcutaneous daily for 7 days (every 4 week cycle) | intervention 1: Azacitidine | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00569660 |
[
5
] | 28 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | true | Deep vein thrombosis(DVT) is a common complication in hospitalized medical patients. Consensus guidelines recommend using medications such as heparin or low-molecular-weight heparins (LMWH) to prevent DVT in these patients. Generally, these medications are given in a fixed dose that is the same for everyone. The approp... | Background and Introduction:
Venous thromboembolism (VTE) is a significant cause of morbidity and mortality in hospitalized patients. It is a well-known complication in patients after major surgery or trauma. More recently, medically ill patients have been identified as another high risk group with up to 15% of patien... | Obesity Venous Thrombosis Anticoagulants | Obesity venous thrombosis Anticoagulants | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Enoxaparin 0.5 mg/kg (kg= actual body weight) subcutaneous once daily for 2 doses. | intervention 1: Enoxaparin 0.5 mg/kg once daily | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00585182 |
[
5
] | 130 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospit... | null | Type 2 Diabetes | type 2 diabetes inpatient hyperglycemia SQ insulin Hospitalized patients with type 2 diabetes | null | 2 | arm 1: Detemir insulin once daily + aspart insulin before meals three times a day at an initial total dose of 0.5 units/kg/day, subcutaneously arm 2: NPH insulin once a day + regular insulin before breakfast and dinner at an initial total dose of 0.5 units/kg/day, subcutaneously | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Detemir insulin SQ once daily + aspart insulin SQ before meals intervention 2: NPH insulin SQ + regular insulin SQ before breakfast and dinner | intervention 1: Detemir + aspart insulin before meals intervention 2: NPH insulin + regular insulin | 2 | Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00590226 |
[
3
] | 28 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma. | null | Asthma | Asthma spirometry lung function serum cortisol serum potassium plasma glucose | null | 2 | arm 1: Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days. arm 2: Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening ... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device. intervention 2: Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device. | intervention 1: indacaterol maleate / mometasone furoate intervention 2: placebo to indacaterol maleate/mometasone furoate | 3 | Neuil | N/A | France | 0.51155 | 47.17219
Paris | N/A | France | 2.3488 | 48.85341
Poitiers | N/A | France | 0.34348 | 46.58261 | 0 | NCT00605306 |
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