phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
4
] | 607 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals. | null | Pancreatic Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Intervenous repeating dose | intervention 1: bevacizumab [Avastin] | 101 | Adelaide | N/A | Australia | 138.59863 | -34.92866
Camperdown | N/A | Australia | 151.17642 | -33.88965
Footscray | N/A | Australia | 144.9 | -37.8
Heidelberg | N/A | Australia | 145.06667 | -37.75
Kurralta Park | N/A | Australia | 138.56702 | -34.95142
Melbourne | N/A | Australia | 144.96332 | -37.814
Melbourne | N/A ... | 1 | NCT01214720 | |
[
4
] | 228 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients with schizophrenia over a long term period. | This is a 48-week, multicenter, open-label (all people know the identity of the intervention), non-controlled, arbitrary-dose study. The patients included in this study are those who participated in the preceding double-blind (neither physician nor patient knows the treatment that the patient receives) comparative tria... | Schizophrenia | Schizophrenia JNS007ER Paliperidone extended-release | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Type= range, unit= mg, number= 3-12, form= tablet, route= oral use. JNS007ER within the range of 3, 6, 9 and 12 mg will be orally administered once daily for 48 weeks. | intervention 1: Paliperidone extended-release (JNS007ER) | 0 | null | 1 | NCT01561898 |
[
3
] | 21 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will examine the effectiveness of the drug pirfenidone in treating focal segmental glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and proteinuria (excessive excretion of protein in the urine). About half of patients with FSGS eventually require kidney dialysis or transp... | The objective of this pilot phase II trial is to evaluate the ability of pirfenidone, a novel anti-fibrotic agent, to reduce the proteinuria and slow the rate of progression of renal insufficiency in patients with focal segmental glomerulosclerosis (FSGS). We will enroll 25 patients with renal biopsy proven FSGS and ev... | Fibrosis Focal Glomerulosclerosis Kidney Failure Nephrotic Syndrome Proteinuria | Fibrosis Nephrotic Syndrome Proteinuria Renal Failure TGF-Beta Focal Segmental Glomerulosclerosis FSGS | null | 0 | null | null | 1 | [
0
] | intervention 1: During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose init... | intervention 1: Pirfenidone | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00001959 |
[
3
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma.
PURPOSE: This study is being performed to determine the effects (... | OBJECTIVES:
* To determine the efficacy of Antineoplaston therapy in adults with anaplastic astrocytoma as measured by an objective response to therapy (complete response, partial response) or stable disease.
* To determine the safety and tolerance of Antineoplaston therapy in adults with anaplastic astrocytoma.
OVER... | Adult Brain Tumor | adult anaplastic astrocytoma | null | 1 | arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. | [
0
] | 1 | [
0
] | intervention 1: Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal). | intervention 1: Antineoplaston therapy (Atengenal + Astugenal) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00003537 |
[
2,
3
] | 55 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The goal of this clinical research study is to find the highest safe dose of the new drug ZARNESTRA (R115777) and temozolomide that can be given to patients with brain tumors (glioblastoma multiforme, GBM). The second goal is to learn if these drugs given in combination can shrink or slow the growth of brain tumors. Th... | Temozolomide works by killing cancer cells. R115777 is a new drug that may slow down the growth of cancer cells. Used in combination, the two drugs may control the growth of brain tumors.
Before treatment starts, patients will have a complete exam, including measurement of height and weight. Blood tests (less than 2 t... | Glioblastoma Multiforme | Brain Neoplasms CNS Diseases Glioblastoma Multiforme Temozolomide Temodar R115777 Zarnestra | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: Starting Dose Level: 100 mg/m\^2 taken by mouth once daily for 7 days, followed by 7 days rest and another 7-day dosing period and 7-day rest period. intervention 2: Starting Dose Level: 400 mg taken by mouth for 7 consecutive days every other week on alternating weeks (days 8-14 and 22-28) every 4 week... | intervention 1: Temozolomide intervention 2: R115777 | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00050986 |
[
4
] | 353 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase. | This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ... | Multiple Myeloma | Multiple Myeloma Refractory and Relapsed Revlimid CC5013 | null | 2 | arm 1: CC-5013 (lenalidomide) plus oral high-dose dexamethasone arm 2: Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle. intervention 2: Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once d... | intervention 1: CC-5013 intervention 2: Dexamethasone | 49 | Hoover | Alabama | United States | -86.81138 | 33.40539
Duarte | California | United States | -117.97729 | 34.13945
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Stanford | California | United States | -122.16608 | 37.42411
New Haven ... | 0 | NCT00056160 |
[
3
] | 90 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED). | IED is a condition characterized by a failure to resist aggressive impulses. IED is a behavioral defined condition for which effective treatments have not been identified. Research suggests that serotonin (5-HT), a chemical that helps regulate mood and emotions, may play a role in the response to pharmacological IED tr... | Intermittent Explosive Disorder | null | 3 | arm 1: Participants will to receive treatment with fluoxetine for 12 weeks arm 2: Participants will to receive treatment with divalproex for 12 weeks arm 3: Participants will to receive treatment with placebo for 12 weeks | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Fluoxetine capsules by mouth, up to 60 mg daily intervention 2: Divalproex ER capsules by mouth, up to 3000 mg daily intervention 3: Placebo capsules by mouth, up to 8 capsules daily | intervention 1: Fluoxetine intervention 2: Divalproex intervention 3: Placebo | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00078754 | |
[
5
] | 115 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection. The anticipated time on study treatment was 3-12 mon... | null | Hepatitis C, Chronic | null | 2 | arm 1: None arm 2: None | [
0,
4
] | 2 | [
0,
0
] | intervention 1: 135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks intervention 2: 400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks | intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: Copegus | 28 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
San Francisco | California | United States | -122.41942 | 37.77493
Aur... | 0 | NCT00087633 | |
[
3
] | 32 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as lon... | null | Breast Cancer | Advanced Breast Cancer | null | 1 | arm 1: Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease prog... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Administered by intravenous infusion. intervention 2: Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicit... | intervention 1: Albumin-bound paclitaxel intervention 2: Carboplatin intervention 3: Herceptin® | 14 | Long Beach | California | United States | -118.18923 | 33.76696
Stamford | Connecticut | United States | -73.53873 | 41.05343
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Hudson | Florida | United States | -82... | 0 | NCT00093145 |
[
4
] | 547 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI \[a chemotherapy regime that combines bolus irinotecan and leucovorin \[LV\] with infusional 5-flu... | null | Colorectal Neoplasms | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
0,
0,
0,
5
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Day 1 \& 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be take... | intervention 1: Modified Bolus 5-FU/LV with Irinotecan intervention 2: FOLFIRI + bevacizumab intervention 3: miFL + bevacizumab intervention 4: Infusional 5-FU/LV with Irinotecan intervention 5: Oral Capecitabine with Irinotecan | 175 | Birmgingham | Alabama | United States | N/A | N/A
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmngham | Alabama | United States | N/A | N/A
Mobile | Alabama | United States | -88.04305 | 30.69436
Flagstaff | Arizona | United States | -111.65127 | 35.19807
Sedona | Arizona | United States | -111.76099 ... | 0 | NCT00101686 | |
[
3
] | 43 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer. | Indication Metastatic Colorectal Cancer Primary Objective To assess the safety of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (The primary objective in the original protocol was to assess progression free survival after treatment with ABX-EGF in combination with the Sa... | Colorectal Cancer | Immunex Panitumumab ABX-EGF Abgenix | null | 2 | arm 1: Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil (5-FU)and leucovorin (IFL chemotherapy regimen) arm 2: Panitumumab (2.5 mg/kg once weekly until disease progression, in... | [
0,
0
] | 4 | [
0,
2,
0,
0
] | intervention 1: Part 1: 125 mg/m\^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m\^2 IV infusion every other week until disease progression or unable to tolerate. intervention 2: Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles. i... | intervention 1: Irinotecan intervention 2: Panitumumab intervention 3: 5-Fluorouracil intervention 4: Leucovorin | 0 | null | 0 | NCT00111761 |
[
2,
3
] | 42 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To assess the maximum tolerated dose and overall safety and tolerability of sunitinib \[SU011248\] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2). | null | Carcinoma, Renal Cell | null | 1 | arm 1: Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib
Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib | [
0
] | 1 | [
0
] | intervention 1: Until disease progression or unacceptable toxicity. | intervention 1: Gefitinib + Sunitinib | 3 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756
New York | New York | United States | -74.00597 | 40.71427
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00113529 | |
[
2,
3
] | 32 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. ... | PRIMARY OBJECTIVES:
I. Determine the frequency of hematologic responses in patients with MDS to 5-aza (azacitidine) plus etanercept.
II. Determine the efficacy of 5-aza combined with etanercept in patients with low or intermediate (int)-1 risk who fail to respond to anti-thymocyte globulin (ATG) plus etanercept and f... | de Novo Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Secondary Myelodysplastic Syndromes | null | 1 | arm 1: Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. | [
0
] | 2 | [
0,
2
] | intervention 1: Given SC or IV intervention 2: Given SC | intervention 1: azacitidine intervention 2: etanercept | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00118287 | |
[
3
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | HIV lipoatrophy is a condition marked by fat loss; it occurs in many patients taking antiretroviral (ARV) therapy that includes nucleoside reverse transcriptase inhibitors (NRTIs). Lipoatrophy may be related to mitochondrial toxicity, a condition that can damage the heart, nerves, muscles, kidneys, and liver, and can a... | NRTIs are an important part of many ARV regimens used to treat HIV infected patients; however, the relationship between NRTI-induced mitochondrial dysfunction and lipoatrophy is still unclear and requires additional research. Additionally, the relationship between the gain in dual-energy x-ray absorptiometry (DEXA)-mea... | HIV Infections Lipodystrophy Metabolic Diseases Nutrition Disorders | lipoatrophy mitochondria HIV treatment experienced | null | 2 | arm 1: NucleomaxX 36 grams TID every other day arm 2: Switch of AZT or d4T to Tenofovir Disoproxil Fumarate | [
0,
1
] | 2 | [
0,
0
] | intervention 1: NucleomaxX 36 grams TID every other day intervention 2: Switch of thymidine nucleoside reverse transcriptase inhibitors to Tenofovir Disoproxil Fumarate | intervention 1: NucleomaxX intervention 2: Tenofovir Disoproxil Fumarate | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00119379 |
[
4
] | 187 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH. | An open-label extension study to evaluate long-term safety of eculizumab in PNH patients who had completed the TRIUMPH (C04-001), SHEPHERD (C04-002), and X03-001 studies. | Paroxysmal Hemoglobinuria, Nocturnal | transfusion dependent paroxysmal nocturnal hemoglobinuria hemolytic | null | 1 | arm 1: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: eculizumab | 40 | Stanford | California | United States | -122.16608 | 37.42411
Hartford | Connecticut | United States | -72.68509 | 41.76371
Weston | Florida | United States | -80.39977 | 26.10037
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Baltimore | Maryland | United States | -76.61219 | 39.29038
Bethesda | Marylan... | 0 | NCT00122317 |
[
4
] | 288 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma | null | Asthma Diabetes Mellitus | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine. intervention 2: Subcutaneous short-acting insulin with dose adjusted according ... | intervention 1: Inhaled Insulin intervention 2: Subcutaneous Insulin | 102 | Glendale | Arizona | United States | -112.18599 | 33.53865
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United State... | 0 | NCT00139659 | |
[
0
] | 6 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this project is to evaluate the hypothesis that bisphosphonate treatment given to growth hormone deficient patients (regardless of current growth hormone replacement therapy status and without changing that status) significantly increases total body bone mineral density during an eighteen month period of... | Adult patients with Dexa scan (bone scan) z-scores \< -1.0 (meaning low bone density) in at least one site will be selected for randomization. All patients who qualify for randomization will undergo baseline bloodwork for serum bone specific alkaline phosphatase (BSAP) and n-terminal telopeptides of collagen (NTX) leve... | Osteopenia | osteopenia growth hormone deficiency pediatric malignancy | null | 2 | arm 1: No bisphosphonate therapy given, participants will take Vitamin D 400 IU daily for 18 months, as well as calcium carbonate 500 mg twice a day for 18 months. arm 2: Bisphosphonate Therapy-Risedronate 35 mg once a week for 18 months, Vitamin D 400 IU daily for 18 months and calcium carbonate 500 mg twice daily for... | [
1,
0
] | 3 | [
0,
7,
7
] | intervention 1: Bisphosphonate therapy given to patients with growth hormone deficiency intervention 2: Vitamin D given to patients with growth hormone deficiency intervention 3: calcium supplement given to patients with growth hormone deficiency | intervention 1: bisphosphonate therapy (risedronate) intervention 2: Vitamin D supplement intervention 3: Calcium | 1 | Syracuse | New York | United States | -76.14742 | 43.04812 | 0 | NCT00145704 |
[
5
] | 23 | NON_RANDOMIZED | SINGLE_GROUP | 9OTHER | 0NONE | false | 0ALL | true | The purpose of this study is to examine the efficacy of quetiapine (Seroquel) in reducing substance use in persons diagnosed with schizophrenia. The primary hypothesis is that quetiapine treatment will be associated with a decrease in substance use. | Comorbid alcohol/substance use disorder (SUD) in schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patients. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia, t... | Schizophrenia Schizoaffective Disorder Psychotic Disorder Substance Abuse Alcohol Abuse | Quetiapine Seroquel Schizophrenia Dual Diagnosis Substance Abuse Alcohol Abuse | null | 1 | arm 1: After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physi... | [
0
] | 1 | [
0
] | intervention 1: After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with st... | intervention 1: Quetiapine | 4 | Augusta | Georgia | United States | -81.97484 | 33.47097
Lebanon | New Hampshire | United States | -72.25176 | 43.64229
Lebanon | New Hampshire | United States | -72.25176 | 43.64229
Manchester | New Hampshire | United States | -71.45479 | 42.99564 | 0 | NCT00156715 |
[
4
] | 599 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion. | null | Macular Edema Retinal Vein Occlusion | null | 3 | arm 1: 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. arm 2: 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. arm 3: Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. | [
0,
0,
3
] | 3 | [
0,
0,
10
] | intervention 1: 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180. intervention 2: 350 µg Dexamethasone intravitreal implant administered on Day 0. intervention 3: Sham injection on Day 0. | intervention 1: 700 µg Dexamethasone intervention 2: 350 µg Dexamethasone intervention 3: Sham Injection | 13 | Los Angeles | California | United States | -118.24368 | 34.05223
Sydney | N/A | Australia | 151.20732 | -33.86785
Graz | N/A | Austria | 15.45 | 47.06667
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
Brno | N/A | Czechia | 16.60796 | 49.19522
Créteil | N/A | France | 2.46569 | 48.79266
Karlsruhe | N/A | Germany... | 0 | NCT00168324 | |
[
4
] | 43 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone | null | Schizophrenia | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid | intervention 1: Ziprasidone | 14 | Avignon | N/A | France | 4.80892 | 43.94834
DOLE Saint YLIE | N/A | France | N/A | N/A
Liévin | N/A | France | 2.78068 | 50.4198
Lyon | N/A | France | 4.84671 | 45.74846
Montfavet | N/A | France | 4.87342 | 43.93335
Orvault | N/A | France | -1.62361 | 47.27117
Rennes | N/A | France | -1.67429 | 48.11198
Saint-Égrève | ... | 0 | NCT00174447 | |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | Based on data supporting the use of cyclophosphamide and etoposide both as single agents in combination and a Phase I study showing acceptable toxicity with a chronic dosing regimen, we propose a Phase II clinical trial. This protocol establishes a model that will test the hypothesis that the use of etoposide and cyclo... | null | Prostate Cancer | prostate cancer recurrent prostate cancer stage IV prostate cancer | null | 1 | arm 1: Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy. Total duration of therapy is 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon... | [
0
] | 2 | [
0,
0
] | intervention 1: 50 mg per day of Etoposide orally for 21 consecutive days. Etoposide will be alternated with oral cyclophosphamide. The drug is administered at night just prior to bed. Week 1 of each cycle will begin with etoposide. intervention 2: 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclo... | intervention 1: Etoposide intervention 2: Cyclophosphamide | 7 | East Brunswick | New Jersey | United States | -74.41598 | 40.42788
Hamilton | New Jersey | United States | -74.08125 | 40.20706
Morristown | New Jersey | United States | -74.48154 | 40.79677
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
New Brunswick | New Jersey | United States | -74.45182 | 40.486... | 0 | NCT00176605 |
[
3
] | 89 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well sorafenib works in treating patients with extensive stage small cell lung cancer. Sorafenib may stop the growth of small cell lung cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. | PRIMARY OBJECTIVES:
I. To evaluate the efficacy of BAY 43-0006 in previously-treated, platinum-sensitive and platinum-refractory patients with measurable disease and extensive stage small cell lung cancer (E-SCLC) in terms of response rate (confirmed and unconfirmed, complete and partial).
SECONDARY OBJECTIVES:
I. T... | Extensive Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer | null | 1 | arm 1: Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 1 | [
0
] | intervention 1: Given orally | intervention 1: sorafenib tosylate | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00182689 | |
[
3
] | 226 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC). | null | Non-small Cell Lung Cancer | null | 2 | arm 1: Pemetrexed 500 mg/m2 arm 2: Pemetrexed 1000 mg/m2 | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 500 mg/m2, intravenous (IV), every 21 days, one year from registration date intervention 2: 1000 mg/m2, intravenous (IV), every 21 days, one year from registration date | intervention 1: Pemetrexed 500 mg/m2 intervention 2: Pemetrexed 1000 mg/m2 | 16 | Chiba | N/A | Japan | 140.11667 | 35.6
Ehime | N/A | Japan | N/A | N/A
Fukuoka | N/A | Japan | 130.41667 | 33.6
Gifu | N/A | Japan | 136.76039 | 35.42291
Gunma | N/A | Japan | N/A | N/A
Hokkaido | N/A | Japan | N/A | N/A
Hyōgo | N/A | Japan | 144.43333 | 43.36667
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Kumamoto |... | 0 | NCT00191191 | |
[
3
] | 150 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the trea... | null | Breast Cancer | null | 3 | arm 1: Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. arm 2: Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients). arm 3: Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Tax... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion) intervention 2: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). intervention 3: Day 1 of 14 day cycle (Cycle 1): 8 mil... | intervention 1: Gemcitabine intervention 2: Carboplatin intervention 3: Herceptin | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 0 | NCT00191451 | |
[
3
] | 95 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. T... | null | Dysmenorrhea | cyclic pelvic pain dysmenorrhea oral contraceptives | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 1 tablet daily by mouth intervention 2: 1 tablet daily by mouth | intervention 1: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets intervention 2: Placebo tablet | 13 | Denver | Colorado | United States | -104.9847 | 39.73915
Decatur | Georgia | United States | -84.29631 | 33.77483
Louisville | Kentucky | United States | -85.75941 | 38.25424
St Louis | Missouri | United States | -90.19789 | 38.62727
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cleveland | Ohio | United Sta... | 0 | NCT00196313 |
[
5
] | 176 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone... | A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years... | Asthma | salmeterol/fluticasone combination Asthma bronchial hyperresponsiveness Children symptom control | null | 2 | arm 1: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg arm 2: fluticasone propionate 2 x 100 mcg | [
1,
5
] | 2 | [
0,
0
] | intervention 1: comparator intervention 2: comparator | intervention 1: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg intervention 2: fluticasone propionate 2 x 100 mcg | 18 | Almere Stad | N/A | Netherlands | 5.21413 | 52.37025
Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
Arnhem | N/A | Netherlands | 5.91111 | 51.98
Breda | N/A | Netherlands | 4.77596 | 51.58656
Eindhoven | N/A | Netherlands | 5.47778 | 51.44083
Enschede | N/A | Netherlands | 6.89583 | 52.21833
Gouda | N/A | Netherlan... | 0 | NCT00197106 |
[
0
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Ziprasidone is a newer drug intended for the treatment of the symptoms of schizophrenia. This new drug may have an added benefit of being able to help with some of the difficulties in problem solving and memory that many patients with schizophrenia experience. The present study wants to look at ziprasidone and two othe... | Typical neuroleptics (i.e., haloperidol, chlorpromazine) are effective at ameliorating the positive psychotic symptoms of schizophrenia but are less efficacious in the treatment of negative symptoms, and there is limited evidence to support their ability to attenuate the cognitive dysfunction observed in schizophrenia ... | Schizophrenia | null | 2 | arm 1: ziprasidone arm 2: risperidone or olanzapine | [
0,
1
] | 1 | [
0
] | intervention 1: ziprasidone target dose is 160 mg/day risperidone target dose is 4 mg/day olanzapine target dose is 20 mg/day | intervention 1: ziprasidone vs risperidone or olanzapine | 1 | Glen Oaks | New York | United States | -73.71152 | 40.74705 | 0 | NCT00225498 | |
[
4
] | 1,683 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators. | null | Thalassemia Sickle Cell Disease Diamond Blackfan Anemia Myelofibrosis | Deferasirox Congenital Anemias Anemias Red Blood Cell Disorders Chronic Iron Overload Transfusional Iron Overload Iron Chelators Oral Iron Chelators Thalassemia Sickle Cell Disease Diamond Blackfan Anemia Myelofibrosis ICL670A | null | 1 | arm 1: Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Starting dose was determined by the frequency of blood transfusions and recommended initial daily dose of deferasirox is 20 mg/kg body weight for patients receiving blood transfusion, 10 ... | [
0
] | 1 | [
0
] | intervention 1: 125 mg, 250 mg and 500 mg tablets. Dosage was calculated based on participant's body weight. Tablets were dispersed in water, orange or apple juice and taken orally once a day. | intervention 1: Deferasirox | 141 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Berkeley | California | United States | -122.27275 | 37.87159
Orange | California | United States | -117.85311 | 33.78779
San Diego | California | United States | -117.16472 | 32.71571
Stanford | California | United States | -122.16608 | 37.42411
Wilmington ... | 0 | NCT00235391 |
[
3
] | 120 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | null | To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are awaiting curative-intent surgery. | null | Breast Cancer | null | 3 | arm 1: Anastrozole Monotherapy arm 2: Fulvestrant Monotherapy arm 3: Anastrozole + Fulvestrant | [
1,
0,
0
] | 2 | [
0,
0
] | intervention 1: 500 mg intramuscular injection intervention 2: oral tablet | intervention 1: Fulvestrant intervention 2: Anastrazole | 1 | Nottingham | N/A | United Kingdom | -1.15047 | 52.9536 | 0 | NCT00259090 | |
[
4
] | 303 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD. | Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents with substance abuse disorders and indicates that they have poorer substance use treatment outcomes and poorer prognosis and risk of persistence and progression of drug use and behavior problems into adulthood. Although r... | ADHD Substance Abuse | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/... | intervention 1: Methylphenidate (OROS-MPH) intervention 2: Methylphenidate (OROS-MPH) - Placebo | 12 | Denver | Colorado | United States | -104.9847 | 39.73915
Jacksonville | Florida | United States | -81.65565 | 30.33218
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Baltimore | Maryland | United States | -76.61219 | 39.29038
Fall River | Massachusetts | United States | -71.15505 | 41.70149
Kansas City... | 0 | NCT00264797 | |
[
4
] | 1,166 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 1FEMALE | false | The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive. | The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG (BSP AG), Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
The previously posted secondary Outcome Measure "Parameters of safety and tolerability" has been removed fro... | Contraception | null | 3 | arm 1: 3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment peri... | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treat... | intervention 1: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300) intervention 2: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) intervention 3: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300) | 35 | Drummondville | Quebec | Canada | -72.48241 | 45.88336
Montreal | Quebec | Canada | -73.58781 | 45.50884
Pointe-Claire | Quebec | Canada | -73.81669 | 45.44868
Québec | Quebec | Canada | -71.21454 | 46.81228
Shawinigan | Quebec | Canada | -72.74913 | 46.56675
Ste-Foy | Quebec | Canada | N/A | N/A
Ettlingen | Baden-Wurt... | 0 | NCT00266032 | |
[
4
] | 1,057 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms. | null | HIV Infections | HIV Treatment Naive | null | 2 | arm 1: Participants were administered an oral dose of ATV 300 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of ATV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks. arm 2: Particip... | [
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 300mg Oral capsules for 96 weeks intervention 2: 100mg Oral Capsules for 96 weeks intervention 3: One tablet with 300 mg - 200 mg once a day for 96 weeks. intervention 4: 400 mg (3 133mg capsules) BID for 96 weeks | intervention 1: ATV intervention 2: RTV intervention 3: Tenofovi-Emtricitabine (TDF/FTC) tablet intervention 4: LPV | 79 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Laguna Beach | California | United States | -117.78311 | 33.54225
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Orlando | Florida | United States | -81.37924 | 28.53... | 0 | NCT00272779 |
[
2,
3
] | 9 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained. | Nesiritide, a recombinant human B-type natriuretic peptide, has vasodilatory, lusitropic and diuretic properties in healthy humans, and improves hemodynamics and symptoms in adults with decompensated congestive heart failure. Several retrospective case series suggest that nesiritide has beneficial effects on hemodynami... | Heart Defects, Congenital Cardiopulmonary Bypass | Nesiritide Natriuretic Peptide, Brain Heart Defects, Congenital Cardiopulmonary Bypass Diuretics | null | 2 | arm 1: In this crossover pilot study, patients are randomly assigned to receive either nesiritide or placebo infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. arm 2: In this crossover pilot study, patients are randomly assigned to receive either nesiritide or plac... | [
2,
0
] | 2 | [
0,
0
] | intervention 1: nesiritide 0.015 mcg/kg/hour x 10 hours intervention 2: 0.9% sodium chloride infusion | intervention 1: nesiritide intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00281671 |
[
3
] | 70 | NON_RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | false | A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen. | A one arm study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen. | Liver Transplantation | Pharmacokinetics Therapy Immunosuppression Drugs, Investigational Adult | null | 1 | arm 1: After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then conv... | [
0
] | 2 | [
0,
0
] | intervention 1: Oral intervention 2: Oral | intervention 1: tacrolimus modified release (MR) intervention 2: tacrolimus | 10 | Palo Alto | California | United States | -122.14302 | 37.44188
Denver | Colorado | United States | -104.9847 | 39.73915
Baltimore | Maryland | United States | -76.61219 | 39.29038
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Rochester | Minne... | 0 | NCT00282243 |
[
3
] | 19 | NON_RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | false | A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen. | A 1 arm study to assess the pharmacokinetics, and long-term safety and effectiveness of a modified release tacrolimus based immunosuppression regimen in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen. | Liver Transplantation | Child Pharmacokinetics Immunosuppression Drugs Hepatic transplant Liver Transplantation | null | 1 | arm 1: Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokineti... | [
0
] | 2 | [
0,
0
] | intervention 1: Oral intervention 2: Oral | intervention 1: tacrolimus modified release (MR) intervention 2: tacrolimus | 5 | Atlanta | Georgia | United States | -84.38798 | 33.749
Indianapolis | Indiana | United States | -86.15804 | 39.76838
New Orleans | Louisiana | United States | -90.07507 | 29.95465
New York | New York | United States | -74.00597 | 40.71427
Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00282256 |
[
3
] | 42 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 1FEMALE | false | A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. | A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline Epithelial Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor expression by random periareolar fine needle aspiration and... | Breast Cancer | breast atypia open label pilot study letrozole fine needle aspiration high risk for breast cancer breast epithelial hyperplasia Ki-67 hormones plus chemoprevention chemoprevention | null | 1 | arm 1: Oral Letrozole 2.5 mg daily for six months | [
0
] | 1 | [
0
] | intervention 1: Letrozole 2.5 mg daily | intervention 1: letrozole | 1 | Kansas City | Kansas | United States | -94.62746 | 39.11417 | 0 | NCT00291135 |
[
3
] | 184 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | A 1-year randomized Phase II core trial was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia 2 years of age and older. Patients who successfully completed the main trial may continue in the extension trial to receive chelation therapy... | null | Anemia Hemosiderosis | β-thalassemia rare chronic anemia iron overload deferasirox chronic anemias transfusional hemosiderosis | null | 1 | arm 1: Deferasirox daily oral dose between 5-40 mg/kg/day | [
0
] | 1 | [
0
] | intervention 1: Deferasirox available as 125 mg, 250 mg or 500 mg tablets | intervention 1: Deferasirox | 28 | Oakland | California | United States | -122.2708 | 37.80437
Stanford | California | United States | -122.16608 | 37.42411
Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Bruges | N... | 0 | NCT00303329 |
[
4
] | 11 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 3TRIPLE | false | 0ALL | true | RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with capecitabine may kill more tumor cel... | OBJECTIVES:
* Determine the efficacy of celecoxib in reducing the incidence and severity of hand/foot syndrome caused by capecitabine in patients with metastatic breast cancer or colorectal cancer.
OUTLINE: This is a placebo-controlled, randomized, double-blind, multicenter study. Patients are stratified according to... | Breast Cancer Colorectal Cancer Pain | Hand-Foot Syndrome cancer-related problem/condition drug/agent toxicity by tissue/organ pain palmar-plantar erythrodysesthesia stage IV breast cancer male breast cancer recurrent breast cancer stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer Celecoxib Celebrex Capecitabine Xel... | null | 2 | arm 1: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day). arm 2: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day) | [
0,
2
] | 4 | [
0,
0,
3,
0
] | intervention 1: Initial dose of 750-1500 mg/m\^2 orally twice a day for each 21 day cycle. intervention 2: 200 mg given orally twice a day for each 21 day cycle. intervention 3: Some patients may undergo radiation therapy 5 days a week for 5-6 weeks, and receive oral capecitabine twice daily 5 days a week. Following co... | intervention 1: Capecitabine intervention 2: Celecoxib intervention 3: Radiation Therapy intervention 4: Placebo | 14 | Santa Rosa | California | United States | -122.71443 | 38.44047
Grand Rapids | Michigan | United States | -85.66809 | 42.96336
Kalamazoo | Michigan | United States | -85.58723 | 42.29171
Kansas City | Missouri | United States | -94.57857 | 39.09973
Springfield | Missouri | United States | -93.29824 | 37.21533
East Syra... | 0 | NCT00305643 |
[
4
] | 269 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve th... | null | Attention Deficit Disorder With Hyperactivity | null | 3 | arm 1: Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks arm 2: Attention-Deficit/Hyperactivity Disorder (ADHD) plus ... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks | intervention 1: atomoxetine | 20 | Acireale | N/A | Italy | 15.16577 | 37.60886
Avellino | N/A | Italy | 14.79103 | 40.91494
Bosisio Parini | N/A | Italy | 9.29 | 45.80075
Brescia | N/A | Italy | 10.21472 | 45.53558
Catania | N/A | Italy | 15.07041 | 37.49223
Coppito | N/A | Italy | 13.34358 | 42.3673
Cremona | N/A | Italy | 10.02129 | 45.13325
Milan | ... | 0 | NCT00320528 | |
[
3
] | 17 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together wi... | OBJECTIVES:
Primary
* Evaluate the response rate in patients with recurrent or metastatic non-small cell lung cancer treated with gemcitabine hydrochloride and imatinib mesylate.
Secondary
* Assess time to progression in patients treated with this regimen.
* Assess overall survival and 1-year survival of patients t... | Lung Cancer | recurrent non-small cell lung cancer stage IV non-small cell lung cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days. intervention 2: 400 mg/day orally, given Days 1-5 and 8-12 every 21 days | intervention 1: gemcitabine hydrochloride intervention 2: imatinib mesylate | 3 | Hamilton | New Jersey | United States | -74.08125 | 40.20706
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
New Brunswick | New Jersey | United States | -74.45182 | 40.48622 | 0 | NCT00323362 |
[
3,
4
] | 120 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following l... | null | Deep Venous Thrombosis | Deep venous thrombosis DVT Heparin induced thrombocytopenia HIT Direct thrombin inhibitor | null | 2 | arm 1: Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100). arm 2: Bo... | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points. in... | intervention 1: Desirudin (Iprivask™) intervention 2: Heparin | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00329433 |
[
3
] | 54 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer.
PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer. | OBJECTIVES:
Primary
* Assess the response rate to therapy within 72 hours of starting daptomycin in cancer patients with neutropenic fever.
Secondary
* Assess the percentage of bacterial cures in patients with documented gram-positive bacterial infections.
* Assess time to afebrile state.
* Assess the pharmacokinet... | Fever Sweating Hot Flashes Infection Neutropenia Unspecified Adult Solid Tumor, Protocol Specific | neutropenia infection unspecified adult solid tumor, protocol specific fever, sweats, and hot flashes | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is \>500 cells/mm\^3. | intervention 1: Daptomycin | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00335478 |
[
4
] | 1,155 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug that has anti inflammatory and neuroprotect... | null | Relapsing Remitting Multiple Sclerosis | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months intervention 2: Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months | intervention 1: Glatiramer Acetate (GA) 40 mg intervention 2: glatiramer acetate 20 mg | 0 | null | 0 | NCT00337779 | |
[
3
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine | In this study, we propose to combine stereotactic body radiotherapy (SBRT) with standard gemcitabine chemotherapy. We hypothesize that earlier administration of systemic chemotherapy may prolong the interval to distant progression and improve overall survival in these patients. In this study, we will treat pancreatic c... | Pancreatic Cancer | Stereotactic Body Radiotherapy (SBRT) pancreas cancer locally advanced local control Gemcitabine | null | 1 | arm 1: Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by... | [
0
] | 4 | [
4,
0,
10,
4
] | intervention 1: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator intervention 2: Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes intervention 3: Patients will undergo this imaging procedure prior to treatment for planning purposes. intervention 4: Patients will hav... | intervention 1: Stereotactic Body Radiotherapy intervention 2: Gemcitabine intervention 3: 4D pancreatic protocol CT scan intervention 4: FDG PET scan | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT00350142 |
[
3
] | 135 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80m... | null | Coronary Heart Disease | null | 2 | arm 1: Dalcetrapib 900mg po daily for 24 weeks arm 2: Placebo po daily for 24 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: po daily for 24 weeks intervention 2: 900mg po daily for 24 weeks | intervention 1: Placebo intervention 2: dalcetrapib | 17 | Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Iowa City | Iowa | United States | -91.53017 | 41.66113
Louisville | Kentucky | United States | -85.75941 | 38.25424
Bethesda | Maryland | United States | -77.10026 | 38.98067
Minneapolis | Minnesota ... | 0 | NCT00353522 | |
[
2
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL). | This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum ... | Adult T-Cell Leukemia and Lymphoma (ATL) Adult Peripheral T-Cell Lymphoma (PTCL) | Adult T-Cell Leukemia ATL Adult Peripheral T-Cell Lymphoma PTCL | null | 1 | arm 1: KW-0761 | [
0
] | 1 | [
0
] | intervention 1: IV administration at 4 escalating dose levels. | intervention 1: KW-0761 | 1 | Tokyo | N/A | Japan | 139.69171 | 35.6895 | 0 | NCT00355472 |
[
4
] | 1,381 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily... | Onychomycosis is common and accounts for about half of all nail disorders. Usually the cause is due to dermatophytes, either Trichophyton rubrum (71%) or Trichophyton mentagrophytes (20%) but may also be due to yeast infection, usually Candida albicans.
The prevalence of onychomycosis in the United States population a... | Onychomycosis | Nail fungus Onychomycosis Itraconazole Toenail | null | 3 | arm 1: Itraconazole 200 mg tablets arm 2: Two Itraconazole 100 mg capsules were taken daily. arm 3: The itraconazole 200-mg tablets and placebo tablets exactly matched one another and were white to slightly grey in color, were oblong and biconvex in shape, and were melt-extrusion, film-coated. | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit. intervention 2: Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit. intervention 3: Placebo tablets are the same... | intervention 1: Itraconazole 100mg capsules intervention 2: Itraconazole 200mg tablets intervention 3: Placebo tablets | 68 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Tuscon | Arizona | United States | N/A | N/A
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Fremont | California | United States | -121.98857 | 37.54827
San Diego | California | United S... | 0 | NCT00356915 |
[
3
] | 13 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer. | null | Breast Cancer | Breast neoplasms breast cancer early breast cancer oncology cancer breast cancer micrometastasis fulvestrant | null | 2 | arm 1: Anastrozole monotherapy arm 2: Anastrozole + Fulvestrant | [
1,
0
] | 2 | [
0,
0
] | intervention 1: intramuscular injection intervention 2: 1 mg oral tablet | intervention 1: Fulvestrant intervention 2: Anastrozole | 25 | Feldkirch | N/A | Austria | 9.6 | 47.23306
Graz | N/A | Austria | 15.45 | 47.06667
Innsbruck | N/A | Austria | 11.39454 | 47.26266
Klagenfurt | N/A | Austria | 14.30528 | 46.62472
Leoben | N/A | Austria | 15.09144 | 47.3765
Linz | N/A | Austria | 14.28611 | 48.30639
Salzburg | N/A | Austria | 13.04399 | 47.79941
Sankt ... | 0 | NCT00357110 |
[
3
] | 52 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The primary objective is to estimate the time to progressive disease for patients who receive LY573636-sodium (hereafter referred to as LY573636) after two previous treatments for metastatic non-small cell lung cancer. Patients will receive an intravenous infusion of study drug once every 21 days. Computed tomography (... | null | Non-Small-Cell Lung Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: A loading dose to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) or 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within these target ranges, intravenous, every 21 days until disease progression. | intervention 1: LY573636-sodium | 7 | Gauting | N/A | Germany | 11.37703 | 48.06919
Großhansdorf | N/A | Germany | 10.28333 | 53.66667
Hamburg | N/A | Germany | 9.99302 | 53.55073
Löwenstein | N/A | Germany | 9.38 | 49.09558
Mannheim | N/A | Germany | 8.46694 | 49.4891
Orbassano | N/A | Italy | 7.53813 | 45.00547
San Sisto | N/A | Italy | 11.80346 | 45.047... | 0 | NCT00363766 | |
[
5
] | 84 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | It has been shown in previous study that progressive glycemic deterioration was associated with progressive loss of b-cell function, measured by the decrease in plasma insulin levels, irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence that thiazolidinediones could have a posit... | null | Type 2 Diabetes Mellitus | Beta cell function Type 2 diabetes Combination treatment | null | 0 | null | null | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: rosiglitazone-metformin intervention 2: Metformin intervention 3: metformin+ gliclazide | 0 | null | 0 | NCT00367055 |
[
4
] | 840 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The study involves the enrollment of patients over 18 years of age with diabetic macular edema(DME). Patients with one study eye will be randomly assigned (stratified by visual acuity and prior laser) with equal probability to one of the three treatment groups:
1. Laser photocoagulation
2. 1mg intravitreal triamcinolo... | Diabetic retinopathy is a major cause of visual impairment in the United States. Diabetic macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision. Data from the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) estimate that after 15 years of known diabetes, the p... | Diabetic Macular Edema | diabetic macular edema intravitreal triamcinolone laser photocoagulation DME | null | 3 | arm 1: Standard of care group: conventional treatment consisting of focal/grid photocoagulation. arm 2: Intravitreal injection of 1mg of triamcinolone acetonide arm 3: Intravitreal injection of 4mg of triamcinolone acetonide | [
1,
0,
0
] | 3 | [
3,
0,
0
] | intervention 1: Standard of care group: conventional treatment consisting of focal/grid photocoagulation. intervention 2: Intravitreal injection of 1mg of triamcinolone acetonide at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retrea... | intervention 1: Standard of Care Group intervention 2: 1mg triamcinolone acetonide intervention 3: 4mg triamcinolone acetonide | 84 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Baldwin Park | California | United States | -117.9609 | 34.08529
Beverly Hills | California | United States | -118.40036 | 34.07362
Irvine | California | United States | -117.82311 | 33.66946
Loma Linda | California | United States | -117.26115 | 34.04835
Lo... | 0 | NCT00367133 |
[
5
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Studies in humans and animals support that stress and/or elevations in corticosteroids lead to changes in hippocampal structure and functioning. This is important as patients with major depression frequently have elevated cortisol, and millions of patients receive prescription corticosteroids (e.g. prednisone). Both de... | SCIENTIFIC PROPOSAL
Aims Primary
1. Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller declines in declarative memory than those receiving placebo.
2. Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller ... | Asthma Rheumatic Disease | Acetaminophen corticosteroids prednisone | null | 2 | arm 1: Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days. arm 2: Participants will be given an identical appearing placebo (two 500 mg tablets) four times daily for 7 days. | [
0,
2
] | 1 | [
0
] | intervention 1: Acetaminophen: Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days, not exceeding 4,000 mg/day. Placebo: Participants will be given placebo(two 500 mg tablets) four times daily for 7 days | intervention 1: Drug: Acetaminophen, Drug: Placebo | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00377364 |
[
3
] | 84 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer | null | Biliary Tract Cancer | null | 2 | arm 1: Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 1000 milligrams per square meter (mg/m2), intravenous (IV) intervention 2: 25 milligrams per square meter (mg/m2), intravenous (IV) | intervention 1: gemcitabine intervention 2: cisplatin | 7 | Aichi | N/A | Japan | 130.62158 | 32.51879
Chiba | N/A | Japan | 140.11667 | 35.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Hokkaido | N/A | Japan | N/A | N/A
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Shizuoka | N/A | Japan | 138.38333 | 34.98333
Tokyo | N/A | Japan | 139.69171 | 35.6895 | 0 | NCT00380588 | |
[
5
] | 97 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder). | null | Autistic Disorder Attention Deficit Disorder With Hyperactivity | null | 2 | arm 1: atomoxetine 0.5 mg/kg/day every day (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks arm 2: placebo every day (QD), by mouth (PO) for 8 weeks
Then patients can take atomoxetine 0.5-1.2 mg/kg/d... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Atomoxetine intervention 2: Placebo | 8 | Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
Groningen | N/A | Netherlands | 6.56667 | 53.21917
Hoorn | N/A | Netherlands | 5.05972 | 52.6425
Maastricht | N/A | Netherlands | 5.68889 | 50.84833
Nijmegen | N/A | Netherlands | 5.85278 | 51.8425
Oosterhout | N/A | Netherlands | 4.85972 | 51.645
The Hague | N/A | Net... | 0 | NCT00380692 | |
[
4
] | 125 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acrome... | null | Acromegaly | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: 120 mg administered via deep subcutaneous injection every 28 days over 28 weeks. intervention 2: Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks. | intervention 1: lanreotide (Autogel formulation) intervention 2: Pegvisomant | 24 | Hradec Králové | N/A | Czechia | 15.83277 | 50.20923
Prague | N/A | Czechia | 14.42076 | 50.08804
Aarhus | N/A | Denmark | 10.21076 | 56.15674
Créteil | N/A | France | 2.46569 | 48.79266
Le Kremlin-Bicêtre | N/A | France | 2.36073 | 48.81471
Lille | N/A | France | 3.05858 | 50.63297
Marseille | N/A | France | 5.38107 |... | 0 | NCT00383708 | |
[
4
] | 654 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according t... | null | Asthma, Bronchial | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Symbicort (budesonide/formoterol) Turbuhaler intervention 2: Conventional treatment | 52 | A Coruña | N/A | Spain | -8.396 | 43.37135
Alagón | N/A | Spain | -1.11906 | 41.76964
Alicante | N/A | Spain | -0.48149 | 38.34517
Almoradí | N/A | Spain | -0.79197 | 38.10879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Burgos | N/A | Spain | -3.70184 | 42.34106
Cadiz | N/A | Spain | -6.2891 | 36.52672
Caravaca | N/A ... | 0 | NCT00385593 | |
[
4
] | 43 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX) in subjects aged 18 and older with active RA is being conducted to assess whether increasing either the infusion dose or infusion frequency in patients presenting with a disease flare after an initial response to infliximab res... | null | Rheumatoid Arthritis | null | 3 | arm 1: Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks arm 2: 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks arm 3: Continuation of infliximab 3 mg/kg every 8 weeks | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks intervention 2: 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks intervention 3: Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks | intervention 1: Infliximab Increased Frequency intervention 2: Infliximab Increased Dose intervention 3: Infliximab Control | 0 | null | 0 | NCT00394589 | |
[
4
] | 223 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This was a Phase III, open-label study conducted at 44 centers in the United States, Canada, and Puerto Rico. 223 subjects who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study. | The study consisted of four visits that corresponded to consecutive HD sessions for each patient, as well as one follow-up visit. Patients could receive up to three treatments with open-label tenecteplase during the study: one or two treatments during an initial treatment course, and eligible patients whose catheter be... | Dysfunctional Hemodialysis Catheters | HD TNKase Hemodialysis Catheter clearance | null | 1 | arm 1: At each treatment, subjects had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Subjects could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatme... | [
0
] | 1 | [
0
] | intervention 1: 2 mL (2 mg) of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter. | intervention 1: Tenecteplase | 0 | null | 0 | NCT00396253 |
[
4
] | 135 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | null | Male osteoporosis is a common and important clinical problem, associated with significant morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given 150 mg once-monthly for 12 months versus placebo... | null | Male Osteoporosis | male osteoporosis osteoporosis bisphonates bone | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Ibandronate orally (tablet) at a dose of 150 mg once per month intervention 2: Placebo orally (tablet) at a dose of 150 mg once per month | intervention 1: Ibandronate intervention 2: placebo | 41 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tucson | Arizona | United States | -110.92648 | 32.22174
Beverly Hills | California | United States | -118.40036 | 34.07362
Greenbrae | California | United States | -122.5247 | 37.94854
Oakland | California | United States | -122.2708 | 37.80437
Palm Desert | ... | 0 | NCT00397839 |
[
5
] | 6 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditis. Patients with this disease will be offered the option of receiving daptomycin at a dose of 8 milligrams/kilogram/day in addition ... | null | Endocarditis, Bacterial | Enterococcus Daptomycin Endocarditis | null | 2 | arm 1: Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving arm 2: Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician | [
0,
4
] | 1 | [
0
] | intervention 1: daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis | intervention 1: Daptomycin | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00401960 |
[
3
] | 3,490 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a loc... | This is a randomized (patients will be assigned to study treatment by chance), double-blind (neither the patient nor the study doctor will know the identity of the assigned study treatment) study to evaluate the safety and efficacy of rivaroxaban (study drug) compared to placebo (a tablet identical in appearance to stu... | Acute Coronary Syndrome | Acute Coronary Syndrome (ACS) Myocardial Ischemia Rivaroxaban (BAY59-7939) Anti-platelet agents Aspirin Thienopyridine Clopidogrel | null | 3 | arm 1: Rivaroxaban 1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. arm 2: Rivaroxaban/Placebo 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will... | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. intervention 2: 1 placebo tablet twice daily for 6 months. intervention 3: 1 rivaroxaban tablet twice daily... | intervention 1: Rivaroxaban/Placebo intervention 2: Placebo intervention 3: Rivaroxaban | 0 | null | 0 | NCT00402597 |
[
5
] | 84 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by comparing study evaluations with the baseline evaluations in the ASCEND (0881A3-402)(NCT00247962) study. | null | Ankylosing Spondylitis | null | 1 | arm 1: Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks. | [
0
] | 1 | [
0
] | intervention 1: Etanercept 50 mg SC injection once weekly | intervention 1: Enbrel (etanercept) | 16 | Fredriksberg | N/A | Denmark | N/A | N/A
Odense | N/A | Denmark | 10.38831 | 55.39594
Svendborg | N/A | Denmark | 10.60677 | 55.05982
Vejle | N/A | Denmark | 9.5357 | 55.70927
Helsinki | N/A | Finland | 24.93545 | 60.16952
Hyvinkää | N/A | Finland | 24.8606 | 60.63195
Kuopio | N/A | Finland | 27.67703 | 62.89238
Tamper... | 0 | NCT00410046 | |
[
3
] | 125 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy. | null | Vitrectomy | null | 4 | arm 1: 25µg of ocriplasmin intravitreal injection arm 2: 75µg of ocriplasmin intravitreal injection arm 3: 125µg of ocriplasmin intravitreal injection arm 4: Intravitreal injection of placebo | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin. intervention 2: Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin. intervention 3: Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin. inte... | intervention 1: Ocriplasmin 25µg intervention 2: Ocriplasmin 75µg intervention 3: Ocriplasmin 125µg intervention 4: Placebo | 20 | Tucson | Arizona | United States | -110.92648 | 32.22174
Huntington Beach | California | United States | -117.99923 | 33.6603
Los Angeles | California | United States | -118.24368 | 34.05223
Poway | California | United States | -117.03586 | 32.96282
Sacramento | California | United States | -121.4944 | 38.58157
Fort Me... | 0 | NCT00412958 | |
[
4
] | 233 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 0NONE | false | 0ALL | null | The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assist... | The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen ... | Bladder Cancer | Recurrence of bladder cancer Fluorescence cystoscopy | null | 2 | arm 1: None arm 2: Standard White light cystoscopy | [
1,
5
] | 2 | [
0,
10
] | intervention 1: Single installation, TURB intervention 2: None | intervention 1: Hexvix intervention 2: Standard white light cystoscopy | 2 | Frederiksberg | N/A | Denmark | 12.53463 | 55.67938
Odense | N/A | Denmark | 10.38831 | 55.39594 | 0 | NCT00412971 |
[
4
] | 424 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receiv... | null | Anemia | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa | intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera] | 105 | Aachen | N/A | Germany | 6.08342 | 50.77664
Aachen | N/A | Germany | 6.08342 | 50.77664
Alzey | N/A | Germany | 8.11513 | 49.74657
Ansbach | N/A | Germany | 10.5931 | 49.30481
Augsburg | N/A | Germany | 10.89851 | 48.37154
Bad König | N/A | Germany | 9.0075 | 49.7432
Bad Nenndorf | N/A | Germany | 9.37904 | 52.33703
Ba... | 0 | NCT00413894 | |
[
4
] | 236 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.
Whether duloxetine once daily can help patients with Chronic Low Back Pain.
Patients who do not have their pain reduced by at least 30% by week 7 will be give... | null | Back Pain Without Radiation | null | 2 | arm 1: 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase arm 2: every day (QD), by mouth (PO), 13 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase intervention 2: every day (QD), by mouth (PO), 13 ... | intervention 1: Duloxetine intervention 2: Placebo | 17 | Curitiba | N/A | Brazil | -49.27306 | -25.42778
São Paulo | N/A | Brazil | -46.63611 | -23.5475
São Paulo | N/A | Brazil | -46.63611 | -23.5475
Amiens | N/A | France | 2.3 | 49.9
Marseille | N/A | France | 5.38107 | 43.29695
Paris | N/A | France | 2.3488 | 48.85341
Saint-Affrique | N/A | France | 2.88915 | 43.95575
Sai... | 0 | NCT00424593 | |
[
3,
4
] | 42 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients will be recruited -14 who will receive plac... | The primary aim of this study is to compare the effect of Octreotide LAR® Depot on the liver volume of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation compared with placebo. The secondary aims o... | Polycystic Kidney, Autosomal Dominant Polycystic Liver Disease Hepatomegaly Liver Diseases Kidney, Polycystic Abdominal Pain | null | 2 | arm 1: Participants received Octreotide LAR® Depot injections (up to 40 mg) intramuscularly every 28 days (+/- 5 days) for one year arm 2: Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Participants received Octreotide LAR® Depot injections (up to 40 mg)intramuscularly every 28 days (+/- 5 days) for one year intervention 2: Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year | intervention 1: Octreotide intervention 2: Placebo | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00426153 | |
[
3
] | 128 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in adult patients. | Following a planned interim analysis in the POC component on 21 August 2008 by the internal DMC (Data Monitoring Committee) of study A4001056, the trial was discontinued due to lack of efficacy. All participating investigators/country offices and monitors were notified on 22 August 2008 to cease patient enrollment. The... | Arthritis, Rheumatoid | null | 2 | arm 1: None arm 2: This study was divided into two components: safety/pharmacokinetic (PK) and proof-of-concept (POC). In the safety/PK component either 150 mg or 300 mg tablets of maraviroc was administered twice a day (BID) to 16 rheumatoid arthritis subjects for 4 weeks. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks. intervention 2: Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks. | intervention 1: Maraviroc intervention 2: Maraviroc Placebo | 44 | Huntington Beach | California | United States | -117.99923 | 33.6603
San Francisco | California | United States | -122.41942 | 37.77493
Hamden | Connecticut | United States | -72.89677 | 41.39593
Meriden | Connecticut | United States | -72.80704 | 41.53815
New Haven | Connecticut | United States | -72.92816 | 41.30815
... | 0 | NCT00427934 | |
[
4
] | 33 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The primary purpose of this study is to:
1. Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially diverse HIV+ population (males and females) who are three-class (nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and protease inhib... | null | HIV Infections | null | 2 | arm 1: Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted. arm 2: Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/... | [
5,
5
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: Patients received between two and four active anti-retroviral medications based on resistance testing results, as background treatment, and remained on these for the duration of the trial. | intervention 1: tipranavir intervention 2: ritonavir intervention 3: Optimized Background Regimen (OBR) | 30 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Clearwater | Florida | United States | -82.8001 | 27.96585
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Orlando | Florida | United States | -81.37924 | 28.53834
Decatur | Georgia | United States | -84.29631 | 33.77483
Kans... | 0 | NCT00440271 | |
[
3
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study will determine whether pioglitazone (Actos, a drug approved to treat diabetes, can benefit HIV-infected people with fatty liver. Fatty changes of the liver (also known as steatosis) have been linked to diabetes and long-term liver damage in some patients. Pioglitazone has been shown to improve fatty liver in... | While the introduction of antiretroviral therapy for HIV/AIDS has transformed HIV disease into a chronic infection for many, the use of antiretroviral therapy is also often associated with metabolic abnormalities including insulin resistance, central fat accumulation and peripheral fat atrophy. Fatty infiltration of th... | HIV Infections Hepatic Steatosis Insulin Resistance | Pioglitazone Hepatic Steatosis Liver Toxicity Liver Biopsy HIV Treatment Experienced Treatment Naive | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: Pioglitazone | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00441272 |
[
3
] | 22 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Primary Objective:
1\. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate
Secondary Objectives:
1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free su... | null | Soft Tissue Sarcoma | null | 1 | arm 1: Glufosfamide | [
0
] | 1 | [
0
] | intervention 1: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles. | intervention 1: Glufosfamide | 7 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Tucson | Arizona | United States | -110.92648 | 32.22174
Stanford | California | United States | -122.16608 | 37.42411
Tampa | Florida | United States | -82.45843 | 27.94752
St Louis | Missouri | United States | -90.19789 | 38.62727
Albuquerque | New Mexico |... | 0 | NCT00441467 | |
[
3
] | 99 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This is a two-part study conducted at multiple centers, of navarixin (SCH 527123, MK-7123) in participants with moderate to severe chronic obstructive pulmonary disease (COPD). Part 1 of the study is a double-blind, placebo-controlled, randomized, rising-dose study consisting of four treatment groups enrolled in three ... | null | Chronic Obstructive Pulmonary Disease | null | 10 | arm 1: Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks arm 2: Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks arm 3: Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to ... | [
0,
2,
0,
2,
0,
2,
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Navarixin 1 mg capsules intervention 2: Navarixin 10 mg capsules intervention 3: Placebo to navarixin capsules intervention 4: Salbutamol/albuterol - 2 puffs of salbutamol/albuterol approximately every 4 hours as needed for dyspnea relief | intervention 1: Navarixin 1 mg intervention 2: Navarixin 10 mg intervention 3: Placebo to match navarixin intervention 4: Rescue medication | 0 | null | 0 | NCT00441701 | |
[
2,
3
] | 2 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) \[Phase I and II\] | Phase I Objectives
* To determine the Maximum Tolerated Dose (MTD) of the combination of (DOXIL) and Abraxane in patients with Metastatic Breast Cancer (MBC).
* Determine the dose-limiting toxicity (DLT) of DOXIL and Abraxane.
Phase II Objectives
Primary Objective
* To determine the response rate of DOXIL and Abrax... | Metastatic Breast Cancer | breast cancer advanced breast cancer | null | 1 | arm 1: Limited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination. | [
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: DOXIL intervention 2: Abraxane | 1 | Morgantown | West Virginia | United States | -79.9559 | 39.62953 | 0 | NCT00442260 |
[
5
] | 229 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines | null | Hypercholesterolemia | Hypercholesterolaemia | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks) intervention 2: atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks) | intervention 1: simvastatin (+) ezetimibe intervention 2: Comparator: atorvastatin | 0 | null | 0 | NCT00442897 |
[
5
] | 3,029 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting. | null | GERD | Gastroesophageal Reflux Disease Acid Reflux | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: This randomized study was conducted on parallel groups and included two phases:
* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
* One maintenance treatment phase, patients were randomized to one ... | intervention 1: esomeprazole (Nexium®) intervention 2: Xolaam® | 1 | Rouen | N/A | France | 1.09932 | 49.44313 | 0 | NCT00444275 |
[
4
] | 11 | null | PARALLEL | 0TREATMENT | null | false | 0ALL | null | The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV or hepatitis B virus (HBV) co-infected HIV+population, three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more than one PI. Determine pharmacokinetic data in this co-infected population and potential ut... | null | HIV Infections | treatment experienced | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: tipranavir intervention 2: ritonavir | 30 | Beverly Hills | California | United States | -118.40036 | 34.07362
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Providence | Rhode Island | United States | -71.41283 | 41.82399
Austin | Texas | United States | -97.74306 | 30.26715
Houston | Texas | United States | -95.36327 | 29.76328
Capital Federa... | 0 | NCT00447902 |
[
5
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB). | null | Overactive Bladder | OAB symptoms of urgency, frequency, and urge incontinence | null | 1 | arm 1: None | [
0
] | 2 | [
1,
0
] | intervention 1: The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). intervent... | intervention 1: Urgent PC Neuromodulation System intervention 2: Tolterodine | 1 | Minnetonka | Minnesota | United States | -93.50329 | 44.9133 | 0 | NCT00448175 |
[
4
] | 906 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen. | HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen.
Subjects will be assigned randomly, in approximately a 2:1 rati... | Ulcer | ibuprofen famotidine ulcers NSAIDS pain arthritis chronic regional pain syndrome chronic soft tissue pain osteoarthritis rheumatoid arthritis chronic low back pain | null | 2 | arm 1: HZT-501: Ibuprofen 800mg/famotidine 26.6mg arm 2: Ibuprofen 800mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks intervention 2: Ibuprofen 800mg administered orally 3 times daily for 24 weeks | intervention 1: Ibuprofen/famotidine intervention 2: Ibuprofen | 0 | null | 0 | NCT00450216 |
[
4
] | 627 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen. | HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen.
Subjects will be assigned randomly, in approximately a 2:1 rati... | Peptic Ulcer | ibuprofen famotidine ulcers NSAIDS pain arthritis chronic regional pain syndrome chronic soft tissue pain osteoarthritis rheumatoid arthritis chronic low back pain | null | 2 | arm 1: HZT-501: Ibuprofen 800mg/Famotidine 26.6mg arm 2: Ibuprofen 800mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks intervention 2: Ibuprofen 800mg orally 3 times daily for 24 weeks | intervention 1: HZT-501 intervention 2: Ibuprofen | 0 | null | 0 | NCT00450658 |
[
5
] | 127 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients. | null | Constipation | null | 3 | arm 1: Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\<6 years of age and able to swallow capsules) who are at least 12 kg body weight arm 2: Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than ... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 12 mcg capsule once daily (QD) intervention 2: 12 mcg capsule twice daily (BID) intervention 3: 24 mcg capsule twice daily (BID) | intervention 1: Lubiprostone intervention 2: Lubiprostone intervention 3: Lubiprostone | 19 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Oakland | California | United States | -122.2708 | 37.80437
Jacksonville | Florida | United States | -81.65565 | 30.33218
Pensacola | Florida | United States | -87.21691 | 30.42131
Park Ridge | Illino... | 0 | NCT00452335 | |
[
5
] | 87 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea. | null | Diabetes Diabetes Mellitus, Type 2 | null | 1 | arm 1: None | [
1
] | 1 | [
0
] | intervention 1: Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin). | intervention 1: insulin detemir | 1 | Seoul | N/A | South Korea | 126.9784 | 37.566 | 0 | NCT00455858 | |
[
3
] | 2 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping th... | OBJECTIVES:
Primary
* Determine the feasibility of neoadjuvant vandetanib in combination with carboplatin and paclitaxel in patients with resectable stage IB, II, or IIIA non-small cell lung cancer.
Secondary
* Assess the 30-day postoperative mortality rate in these patients.
* Assess the toxicity of this regimen i... | Lung Cancer | stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer | null | 1 | arm 1: Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.
Neoadjuvant Surge... | [
0
] | 4 | [
0,
0,
0,
3
] | intervention 1: Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 intervention 2: Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. intervention 3: Zactima- 100 mg orally daily, starting on day 1 of cycle 1. intervention 4: Neoadjuvant surgery: Surgical resection of the tumor will be pe... | intervention 1: carboplatin intervention 2: paclitaxel intervention 3: Zactima intervention 4: neoadjuvant therapy | 1 | Detroit | Michigan | United States | -83.04575 | 42.33143 | 0 | NCT00459121 |
[
3
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone. | Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published resu... | Non Small Cell Lung Cancer | null | 1 | arm 1: None | [
0
] | 3 | [
2,
0,
4
] | intervention 1: 8 mg/kg intervention 2: Combination of cisplatin and docetaxel administered as two cycles given every three weeks intervention 3: 64 Gy in 32 fractions over 6.5 weeks | intervention 1: Zalutumumab intervention 2: Induction chemotherapy intervention 3: Radiotherapy | 8 | Towson | Maryland | United States | -76.60191 | 39.4015
Portland | Oregon | United States | -122.67621 | 45.52345
Ghent | N/A | Belgium | 3.71667 | 51.05
Liège | N/A | Belgium | 5.56749 | 50.63373
Liège | N/A | Belgium | 5.56749 | 50.63373
Reims | Cedex | France | 4.02853 | 49.26526
Amsterdam | N/A | Netherlands | 4.88... | 0 | NCT00460551 | |
[
4
] | 10 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by darunavir/ritonavir and TMC125 in HIV positive patients who can n... | This is a multi-center, open-label (doctors and patients know which drug is being given), Phase IIIb clinical trial to evaluate the effectiveness, safety and tolerability of the combination of PREZISTA (darunavir)/ritonavir and TMC125 when substituted for enfuvirtide, current protease inhibitor(s) and Non-Nucleoside Re... | HIV | HIV AIDS Immunodeficiency Virus, Human PREZISTA darunavir TMC114 TMC125 Protease Inhibitor Non-Nucleoside Reverse Transcriptase Inhibitor enfuvirtide Treatment Experienced | null | 1 | arm 1: TMC125, Darunavir; RitonavirTMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks; | [
0
] | 1 | [
0
] | intervention 1: TMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks; | intervention 1: TMC125, Darunavir; Ritonavir | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00460746 |
[
4
] | 110 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional diuretic. | null | Edema, Cardiac | Cardiac edema OPC-41061 Vasopressin antagonist | null | 2 | arm 1: 0mg arm 2: 15mg OPC-41061 | [
2,
0
] | 1 | [
0
] | intervention 1: 0, 15mg of OPC-41061 per day for 7days p.o. administration | intervention 1: OPC-41061(Tolvaptan) | 8 | Chubu Region | N/A | Japan | N/A | N/A
Chugoku Region | N/A | Japan | N/A | N/A
Hokkaido Region | N/A | Japan | N/A | N/A
Kanto Region | N/A | Japan | N/A | N/A
Kinki Region | N/A | Japan | N/A | N/A
Kyushu Region | N/A | Japan | N/A | N/A
Shikoku Region | N/A | Japan | N/A | N/A
Tohoku Region | N/A | Japan | N/A | N/A | 0 | NCT00462670 |
[
4
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells Syndrome.
Part I is an 8-week open-label, active treatment period to identify ACZ885 responde... | null | Muckle Wells Syndrome | Muckle-Wells Syndrome children systemic autoinflammatory disease CIAS-1 gene NALP-3 ACZ885 human monoclonal anti-human interleukin-1beta (IL-1beta) antibody autosomal dominant familial autoinflammatory syndrome | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: ACZ885 intervention 2: Placebo | 12 | San Francisco | California | United States | -122.41942 | 37.77493
Chicago | Illinois | United States | -87.65005 | 41.85003
Madison | Wisconsin | United States | -89.40123 | 43.07305
Le Kremlin-Bicêtre | N/A | France | 2.36073 | 48.81471
Lille | N/A | France | 3.05858 | 50.63297
Montpellier | N/A | France | 3.87635 | ... | 0 | NCT00465985 |
[
3
] | 296 | null | PARALLEL | 0TREATMENT | null | false | 0ALL | null | The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and ph... | null | Asthma | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: BI 1744 CL | 37 | Lakewood | California | United States | -118.13396 | 33.85363
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Wheat Ridg... | 0 | NCT00467740 | |
[
5
] | 46 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension | null | Glaucoma Ocular Hypertension | null | 2 | arm 1: 3 period, 2 treatment cross-over model:
Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then parti... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) intervention 2: group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 dro... | intervention 1: travoprost 0.004% and brinzolamide 1% intervention 2: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle | 1 | Catania | N/A | Italy | 15.07041 | 37.49223 | 0 | NCT00471380 | |
[
3
] | 157 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol. | Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack, specifically for patients who have heart disease plus major risk factors. Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations fo... | Hypercholesterolemia | cholesterol | null | 6 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None | [
2,
1,
0,
0,
0,
0
] | 6 | [
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 1: Atorvastatin 20 mg intervention 2: AEGR-733 5 mg intervention 3: AEGR-733 10 mg intervention 4: Placebo intervention 5: AEGR-733 5 mg + atorvastatin 20 mg intervention 6: AEGR-733 10 mg + atorvastatin 20 mg | 17 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Jacksonville | Florida | United States | -81.65565 | 30.33218
Jacksonville | Florida | United States | -81.65565 | 30.33218
Ocala | Florida | United States | -82.14009 | 29.1872
Woodstock | Georgia | United States | -84.51938 | 34.10149
Chicago | Illinois | Uni... | 0 | NCT00474240 |
[
0
] | 188 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | Pain control after cesarean delivery is associated with improved breastfeeding and infant rooming-in times. In addition, inadequate analgesia leads to elevated plasma catecholamine concentrations, which negatively affect every organ system. There is growing evidence that ketamine, N-methyl-D-aspartate receptor antagoni... | Eligible women for elective cesarean section admitted to the Labor and Delivery Unit of Prentice Women's Hospital will be approached for study participation immediately after the routine preanesthetic evaluation. This occurs shortly after admission to the Labor and Delivery Unit. Women who agree to participate will giv... | Ketamine Adverse Reaction Effects of; Anesthesia, Spinal and Epidural, in Pregnancy Complication of Labor and/or Delivery | Ketamine Spinal Anesthesia C-section | null | 2 | arm 1: Subjects receive IV ketamine 10 mg 5 minutes after infant delivery. arm 2: Subjects receive IV Saline 20 mL 5 minutes after infant delivery | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Ketamine 10 mg diluted to 20 mL delivered over 10 minutes via an infusion pump set at 2ml/minute intervention 2: Saline 20 mL IV infusion delivered over 10 minutes via an infusion pump set at 2ml/minute | intervention 1: Ketamine intervention 2: Placebo | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00486902 |
[
5
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received ... | null | HIV Infections | Treatment Experienced | null | 2 | arm 1: Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® \[raltegravir\] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretrov... | [
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 90 mg SC twice daily intervention 2: As prescribed intervention 3: As prescribed intervention 4: 180 mg SC once daily | intervention 1: enfuvirtide [Fuzeon] intervention 2: Optimized background ARV intervention 3: Integrase inhibitor intervention 4: enfuvirtide [Fuzeon] | 43 | Hobson City | Alabama | United States | -85.84413 | 33.62149
Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Los An... | 0 | NCT00488059 |
[
4
] | 539 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental anal... | Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose... | Low Back Pain | Chronic pain opioid transdermal Moderate to severe chronic low back pain | null | 2 | arm 1: Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear arm 2: Placebo transdermal system to match BTDS patches, applied for 7 days | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days intervention 2: transdermal system (placebo) worn for 7 days | intervention 1: Buprenorphine transdermal system intervention 2: Placebo | 86 | Anniston | Alabama | United States | -85.83163 | 33.65983
Mobile | Alabama | United States | -88.04305 | 30.69436
Chandler | Arizona | United States | -111.84125 | 33.30616
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United Stat... | 0 | NCT00490919 |
[
3
] | 4 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer | Two 21-day cycles of pemetrexed (500 milligrams per square meter \[mg/m2\] intravenous \[IV\] infusion) and carboplatin (target area under the curve \[AUC\] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray ... | Small Cell Lung Cancer | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
3
] | intervention 1: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles intervention 2: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles intervention 3: 2 Gray (Gy) per fraction, 5 f... | intervention 1: pemetrexed intervention 2: carboplatin intervention 3: radiotherapy | 12 | Orbassano | N/A | Italy | 7.53813 | 45.00547
Parma | N/A | Italy | 10.32618 | 44.79935
San Sisto | N/A | Italy | 11.80346 | 45.0476
Terni | N/A | Italy | 12.64329 | 42.56335
Poznan | N/A | Poland | 16.92993 | 52.40692
Warsaw | N/A | Poland | 21.01178 | 52.22977
Madrid | N/A | Spain | -3.70256 | 40.4165
Palma de Mallorc... | 0 | NCT00494026 | |
[
3
] | 2 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's di... | Eligible pediatric patients with acute flares of ileocecal Crohn's disease will be randomized to receive either PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 wee... | Crohn's Disease | Crohn's Crohn's Disease Acute Flare Mild to Moderate Crohn's Disease Children Pediatrics Ileo-cecal Pediatric Crohn's Disease New Onset Crohn's Disease Recently diagnosed Crohn's Disease | null | 2 | arm 1: 4-Aminosalicylic acid extended release granules (as volume equivalent of active product), 50 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 50 mg/kg orally two times daily for 2 weeks arm 2: Placebo granules identical in appearance to the active arm (as volume equivalent of activ... | [
0,
2
] | 1 | [
0
] | intervention 1: Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm | intervention 1: 4-Aminosalicylic acid extended release granules | 5 | Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Atlanta | Georgia | United States | -84.38798 | 33.749
Morristown | New Jersey | United States | -74.48154 | 40.79677
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00495521 |
[
3
] | 84 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Primary Objectives:
1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups.
2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups.
Secondary Objectives:
1. To determine the degree of expression of v... | Granulocyte-colony stimulating factor (G-CSF) and granulocyte macrophage-colony stimulating factor (GM-CSF) are synthetic (man-made) versions of substances naturally produced in your body. These substances, called colony stimulating factors, help the bone marrow to make new white blood cells. When certain cancer medici... | Lymphoma | Non-Hodgkin's Lymphoma Lymphoma Etoposide G-CSF GM-CSF Isophosphamide Rituximab Ifosfamide Sargramostim Leukine Filgrastim Neupogen Apheresis Stem Cell Collection | null | 2 | arm 1: Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF) arm 2: Growth Factor = granulocyte-colony stimulating factor (G-CSF) | [
0,
0
] | 6 | [
0,
0,
0,
0,
0,
3
] | intervention 1: 150 mg/m\^2 given intravenously over 2 hours every 12 hours x 6 doses. intervention 2: Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis. intervention 3: 250 mcg/m\^2 injection given every evening till the completion of apheresis. intervention 4: 10 g/m\^2 given ... | intervention 1: Etoposide intervention 2: G-CSF intervention 3: GM-CSF intervention 4: Isophosphamide intervention 5: Rituximab intervention 6: Apheresis | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00499343 |
[
4
] | 241 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will include the patients who are Japanese children with bronchial asthma aged 5 years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of 100 µg to 800 µg for 54 weeks treatment includi... | null | Asthma | Asthma Bronchial | null | 2 | arm 1: Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily arm 2: Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily intervention 2: According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. | intervention 1: Budesonide intervention 2: Conventional Asthma Therapy | 1 | Takizawa | Iwate | Japan | 141.13466 | 39.8028 | 0 | NCT00509028 |
[
4
] | 471 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes. | null | Diabetes Mellitus, Type 2 | diabetes type 2 | null | 2 | arm 1: Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks arm 2: Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks intervention 2: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks | intervention 1: Insulin Lispro Protamine Suspension intervention 2: Insulin Glargine | 17 | Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Huntington Park | California | United States | -118.22507 | 33.98168
Miami | Florida | United States | -80.19366 | 25.77427
Atlanta | Georgia | United States | -84.38798 | 33.749
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Wichita | Kansas | U... | 0 | NCT00510952 |
[
3
] | 28 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth | PRIMARY OBJECTIVES:
I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA) response rate and progression-free survival (PFS) in comparison with historical controls for patients with hormone-refractory prostate cancer (HRPC).
II. Evaluate the time to treatment failure and overall survi... | Hormone-resistant Prostate Cancer Recurrent Prostate Cancer | null | 1 | arm 1: Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. | [
0
] | 2 | [
0,
10
] | intervention 1: Given orally intervention 2: Correlative studies | intervention 1: saracatinib intervention 2: laboratory biomarker analysis | 1 | Duarte | California | United States | -117.97729 | 34.13945 | 0 | NCT00513071 | |
[
4
] | 6 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). | This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib ... | Myelogenous Leukemia | leukemia bone marrow leukemia symptoms cml complete blood count lymphocyte blood cancer leukocytes chronic leukemia bone marrow biopsy leukemia research leukemia cells bone marrow disease chronic myeloid leukemia blood cancer symptoms white blood cell diseases chronic myelogenous leukemia leukemia treatment leukemia fa... | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days. intervention 2: Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of... | intervention 1: Imatinib intervention 2: Nilotinib (AMN107) | 80 | Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United States | -117.9145 | 33.83529
Baldwin Park | California | United States | -117.9609 | 34.08529
Fontana | California | United States | -117.43505 | 34.09223
Hayward | California | United States | -122.0808 | 37.66882
Los Angeles | Cal... | 0 | NCT00519090 |
[
5
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough level... | null | Common Variable Immunodeficiency Agammaglobulinemia | Previously Untreated Patient (PUP) Primary Immunodeficiency (PID) CVID XLA Subcutaneous immunoglobulin (SCIG) IgG trough level Quality of life Common variable immunodeficiency (CVID) X-linked agammaglobulinemia (XLA) | null | 1 | arm 1: Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks. | [
0
] | 1 | [
0
] | intervention 1: Human normal immunoglobulin G (IgG) for subcutaneous (SC) use. | intervention 1: Vivaglobin | 6 | Edmonton | Alberta | Canada | -113.46871 | 53.55014
Montreal | Quebec | Canada | -73.58781 | 45.50884
Leipzig | N/A | Germany | 12.37129 | 51.33962
Brescia | N/A | Italy | 10.21472 | 45.53558
Roma | N/A | Italy | 11.10642 | 44.99364
Madrid | N/A | Spain | -3.70256 | 40.4165 | 0 | NCT00520494 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.