phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 84 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC). | null | Non-small Cell Lung Cancer | Lung Neoplasms | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: AUC of 6 mg\*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices. intervention 2: 175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices. intervention 3: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after com... | intervention 1: carboplatin intervention 2: paclitaxel intervention 3: sunitinib | 31 | Los Angeles | California | United States | -118.24368 | 34.05223
Newark | Delaware | United States | -75.74966 | 39.68372
Newark | Delaware | United States | -75.74966 | 39.68372
Wilmington | Delaware | United States | -75.54659 | 39.74595
Maywood | Illinois | United States | -87.84312 | 41.8792
Jeffersonville | Indian... | 0 | NCT00113516 |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This will be an open label, multi-center study of up to 77 patients with CML in chronic, accelerated or blast phase who have developed resistance to or have failed previous treatment with Gleevec (imatinib mesylate). Because these patients may still be sensitive to Gleevec, adding Homoharringtonine may restore a respon... | Every 4 weeks, the study medicine Homoharringtonine will be given by vein daily for 5 days along with continuing daily doses of the approved medicine Gleevec taken by mouth. The safety and effectiveness of this combined treatment in CML patients will be studied. Patients who do not achieve a meaningful hematologic or c... | Myeloid Leukemia, Chronic Myeloid Leukemia, Chronic, Accelerated-Phase Blast Phase Myeloid Leukemia, Chronic, Chronic-Phase | ChemGenex Pharmaceuticals, Ltd ChemGenex Pharmaceuticals ChemGenex Chronic Myeloid Leukemia Myeloid Leukemia, Chronic Leukemia Myeloid Leukemia Chronic Phase Accelerated Phase Blast Phase Myeloid, Leukemia, Chronic, Accelerated Phase Myeloid, Leukemia, Chronic Leukemia, Myeloid, Chronic Leukemia, Myeloid, Chronic-Phase... | null | 1 | arm 1: Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 60... | [
0
] | 2 | [
0,
0
] | intervention 1: Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m\^2 by continuous 24-hour intravenous (IV) infusion daily on Days 1-5 of each 4 week treatment cycle. Participants who do not achieve a meaningful hematologic or cytogenetic response by the end of the fourth cycle are discontinued fro... | intervention 1: Homoharringtonine intervention 2: Imatinib Mesylate | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00114959 |
[
3
] | 189 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of the study is to:
* Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a
* Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BA... | Analyses on Biomarkers were exploratory and assessed as tertiary objective of the trial. | Carcinoma, Renal Cell | Renal Cell Cancer RCC Cancer | null | 2 | arm 1: Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Multi kinase inhibitor intervention 2: Interferon | intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Interferon | 42 | Sacramento | California | United States | -121.4944 | 38.58157
Aurora | Colorado | United States | -104.83192 | 39.72943
Chicago | Illinois | United States | -87.65005 | 41.85003
Frederick | Maryland | United States | -77.41054 | 39.41427
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Cleveland | Ohio | Uni... | 0 | NCT00117637 |
[
3
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with metastatic and/or locally advanced or locally recurrent thyroid cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killin... | PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with metastatic and/or locally advanced or locally recurrent thyroid cancer treated with suberoylanilide hydroxamic acid.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this drug in these patients.
OUTLINE:
Patients receive oral suberoyla... | Insular Thyroid Cancer Recurrent Thyroid Cancer Stage II Follicular Thyroid Cancer Stage II Papillary Thyroid Cancer Stage IV Follicular Thyroid Cancer Stage IV Papillary Thyroid Cancer Thyroid Gland Medullary Carcinoma | null | 1 | arm 1: Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 cou... | [
0
] | 1 | [
0
] | intervention 1: Given orally | intervention 1: vorinostat | 1 | Columbus | Ohio | United States | -82.99879 | 39.96118 | 0 | NCT00134043 | |
[
3
] | 57 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | true | 0ALL | true | There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia. | There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. In this study, we are investigating whether the combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking i... | Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder | tobacco | null | 4 | arm 1: Contingent reinforcement plus bupropion arm 2: Contingent reinforcement plus placebo arm 3: Non-contingent reinforcement plus bupropion arm 4: Non-contingent reinforcement plus placebo | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Contingent reinforcement plus bupropion (300 mg/day for 3 weeks) intervention 2: contingent reinforcement plus placebo (3 weeks) intervention 3: non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks) intervention 4: Non-contingent reinforcement plus placebo | intervention 1: Bupropion intervention 2: Contingent reinforcement plus placebo intervention 3: non-contingent reinforcement plus bupropion intervention 4: Non-contingent reinforcement plus placebo | 1 | Providence | Rhode Island | United States | -71.41283 | 41.82399 | 0 | NCT00136760 |
[
4
] | 77 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | null | Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of immunosuppressive drugs) given in combination with basiliximab, cyclosporine and steroids in pediatric d... | null | Liver Transplantation Infection | pediatric liver transplantation Simulect Basiliximab ciclosporin microemulsion steroid reduction pediatric liver transplantation | null | 2 | arm 1: Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was \<35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus i... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight \<35 kg) or 20 mg (body weight ≥35 kg) strength. intervention 2: Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m²/day intraven... | intervention 1: Basiliximab intervention 2: Cyclosporine/cyclosporine microemulsion intervention 3: Steroid | 1 | Various Cities | N/A | Germany | N/A | N/A | 0 | NCT00149890 |
[
2,
3
] | 33 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The primary aim is to evaluate the safety (Phase I components) of administering bexarotene (Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin (Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This study will also evaluate the preliminary efficacy (Pha... | The phase I portion of the study will evaluate the safety of administering bexarotene oral capsules daily at two dose levels (300 mg/m2 and 400 mg/m2) in combination with carboplatin and Taxol®. At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an indi... | Carcinoma, Non-small-cell Lung | NSCLC Bexarotene Targretin | null | 1 | arm 1: Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1). | [
0
] | 2 | [
0,
0
] | intervention 1: Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1).
Level 1: 300 mg intervention 2: Bexarotene oral capsules will be administered daily beginning on the intitial day of chemotherapy (Day 1).
Level 2: 400 mg | intervention 1: Bexarotene (targretin) intervention 2: Bexarotene (targretin) | 1 | Lebanon | New Hampshire | United States | -72.25176 | 43.64229 | 0 | NCT00153842 |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults. | This study will include patients with moderate to severe psoriasis who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved PASI 75. They will be given acitretin 25 mg/day. The combined treatment will occur over 6 months. Subjects' progress will be assessed monthly, based on the... | Psoriasis | psoriasis etanercept acitretin | null | 1 | arm 1: open-label | [
0
] | 1 | [
0
] | intervention 1: Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months. | intervention 1: acitretin | 0 | null | 0 | NCT00156247 |
[
3,
4
] | 23 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | Trastuzumab or Herceptin is an antibody directed against Her-2. Her-2 is a growth factor receptor which is present on the tumors of 25% of patients with breast cancer. The addition of trastuzumab to chemotherapy has been shown in a randomized clinical trial to increase the response rate to chemotherapy, the duration of... | This is a randomized phase II study comparing trastuzumab with G-CSF against trastuzumab with placebo during the first two weeks of therapy.
Twenty five patients with metastatic breast cancer will be randomized to receive weekly trastuzumab plus either G-CSF or placebo by subcutaneous (SQ) injection daily for five day... | Metastatic Breast Cancer | Breast cancer Her-2/neu Granulocyte Colony Stimulating Factor Trastuzumab Vinorelbine Antibody-dependent cellular cytotoxicity Effector cells | null | 2 | arm 1: Subjects will receive ten doses of G-CSF at a dose of 5 mcgm/kg daily Monday through Friday for the first two weeks of the trial. All patients will also receive trastuzumab at 4 mg/kg week 1, and 2 mg/kg week 2 during the first two weeks of the trial. All patients will then receive 12 weeks of trastuzumab at 2 m... | [
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 5 mcgm/kg daily Monday through Friday weeks 3-14 intervention 2: 4 mcgm/kg intravenously (IV) over 90 minutes week 1, then 2 mg/kg IV over 30 minutes weeks 2-14 intervention 3: 25 mg/m2 over 6 minutes IV weekly, weeks 3, 4, 6, 7, 9, 10, 12, 13 intervention 4: 5 mcgm/kg SQ daily for ten days, Monday thro... | intervention 1: G-CSF intervention 2: trastuzumab intervention 3: vinorelbine intervention 4: G-CSF intervention 5: saline placebo | 0 | null | 0 | NCT00169104 |
[
3,
4
] | 10 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The researchers hypothesize that it will be possible to perform unrelated bone marrow or cord blood transplants in a safer manner by using less intensive therapy yet still achieve an acceptable level of donor cell engraftment for non-malignant congenital bone marrow failure disorders. | Prior to transplantation, subjects will receive the drugs busulfan (orally or through the catheter), as well as fludarabine and anti-thymocyte globulin (ATG) via the catheter. Busulfan, fludarabine and ATG will be given with Total Lymphoid Irradiation (TLI) to help the new donor bone marrow take and grow after transpla... | Diamond-Blackfan Anemia Kostmann's Neutropenia Shwachman-Diamond Syndrome | Stem cell transplant T-cell depletion TLI bone marrow failure disorders | null | 1 | arm 1: Patients with Diamond-Blackfan Anemia, Kostmann's Neutropenia, Shwachman-Diamond Syndrome | [
0
] | 5 | [
3,
0,
3,
0,
2
] | intervention 1: Stem cell transplant on Day 0 - healthy marrow from an unrelated individual. A minimum of 1.0 x 10\^9/kg nucleated cells/kg ideal body weight will be collected with a goal of 2.0 x 10\^9/kg. intervention 2: fludarabine 175 mg/m\^2 (total) on Days -6 through -3. intervention 3: Dose 500 cGy radiation the... | intervention 1: Stem cell transplant intervention 2: Fludarabine monophosphate intervention 3: Total lymphoid irradiation intervention 4: Busulfan intervention 5: anti-thymocyte globulin | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00176878 |
[
5
] | 155 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | The current study is a continuation of the 5 year extension study of the phase III CHAMPS study (see reference). This study was designed to determine if immediate initiation of therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS) continues to delay the development of further attacks ... | The CHAMPS study determined that immediate initiation of interferon beta 1a therapy (AVONEX) immediately following a first clinical demyelinating event in high risk patients (i.e. those with at least 2 asymptomatic white matter lesions on cranial MR imaging \> 3 mm in diameter or ovoid) delayed the development of clini... | Multiple Sclerosis Optic Neuritis Transverse Myelitis Acute Brainstem/Cerebellar Syndrome | Multiple sclerosis Interferon Beta MRI Optic neuritis Transverse Myelitis | null | 2 | arm 1: Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals arm 2: Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term obs... | [
0,
1
] | 1 | [
0
] | intervention 1: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled... | intervention 1: interferon beta 1a 30 ug IM once weekly | 26 | Derby | Connecticut | United States | -73.089 | 41.32065
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Elk Grove | Illinois | United States | -87.94034 | 42.00725
Iowa City | Iowa | United States | -91.53017 | 41.66113
Boston | Massachusetts | United State... | 0 | NCT00179478 |
[
3
] | 110 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study... | Upon determination of eligibility, all patients will be receive:
Gemcitabine + Epirubicin + Docetaxel | Breast Cancer | null | 1 | arm 1: In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were a... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Gemcitabine intervention 2: Epirubicin intervention 3: Docetaxel | intervention 1: Gemcitabine intervention 2: Epirubicin intervention 3: Docetaxel | 0 | null | 0 | NCT00193050 | |
[
3
] | 14 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms. | OCD is a chronic and disabling disorder for which Selective Serotonin Reuptake Inhibitor(SSRI) drugs can be effective. The purpose of this study is to evaluate the effects of an SSRI, escitalopram, in OCD patients.
This study will last 16 weeks and will comprise 2 phases. Phase 1 is an open label in which all particip... | OCD | OCD SSRI escitalopram relapse | null | 3 | arm 1: Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects. arm 2: Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at lea... | [
0,
2,
1
] | 2 | [
0,
0
] | intervention 1: Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day. intervention 2: Placebo Comparator in double.blind phase. | intervention 1: escitalopram intervention 2: Placebo ( sugar pill) | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00215137 |
[
3
] | 49 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | Docetaxel-based therapy has been shown to prolong survival as first-line therapy for patients with hormone refractory prostate cancer (HRPC), and has become the standard of care. The beneficial effects of any therapy in HRPC may be diverse and include reduction in tumor bulk (when measurable), reduction in prostate-spe... | OUTLINE: This is a multi-center study.
* Pemetrexed 500mg/m2 will be administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle.
* Folic Acid (350-1000 mcg. PO daily) will be taken by patients to reduce toxicity. At least 5 daily doses of folic acid must be taken during the 7-day period preced... | Prostate Cancer | Prostate Cancer | null | 1 | arm 1: * Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
* Oral Folic Acid, once per day for 7 days preceding pemetrexed dose, continued daily, and for 21 days after the last dose of pemetrexed.
* Vitamin B12, 1000ug intramuscular injection 7 days preceding pemetrexed dose, and every three cycles thereaf... | [
0
] | 3 | [
0,
7,
7
] | intervention 1: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle intervention 2: All participants received oral Folic Acid 350-100ug once per day for 7 days preceding the first pemetrexed dose and continuing throughout the study and and for 21 days after the last dose of pemetrexed. intervention 3: All pa... | intervention 1: Pemetrexed intervention 2: Folic Acid intervention 3: Vitamin B12 | 15 | Galesburg | Illinois | United States | -90.37124 | 40.94782
Elkhart | Indiana | United States | -85.97667 | 41.68199
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Indianapolis | India... | 0 | NCT00216099 |
[
3
] | 11 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation ther... | OBJECTIVES:
Primary
* Determine the clinical response in patients with recurrent or refractory, metastatic, or unresectable osteosarcoma treated with high-dose samarium Sm 153 lexidronam pentasodium (\^153Sm-EDTMP) and autologous peripheral blood stem cell transplantation followed by external-beam radiotherapy.
* Cor... | Sarcoma | recurrent osteosarcoma metastatic osteosarcoma localized osteosarcoma | null | 1 | arm 1: Cytoxan+Ifosfamide, Filgrastim pre samarium.'Sm-EDTMP (low dose). once counts recover, Sm-EDTMP (high dose) given. Peripheral blood stem cell transplantation is done 14 days later. | [
0
] | 5 | [
2,
0,
3,
4,
4
] | intervention 1: Filgrastim will be administered post post chemotherapy until target WBC (white blood cell) count is achieved. intervention 2: Ifosfamide administered IV. intervention 3: Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered intervention 4: Sm-EDTMP (low dose)... | intervention 1: filgrastim intervention 2: ifosfamide intervention 3: peripheral blood stem cell transplantation intervention 4: Sm-EDTMP (low dose) intervention 5: sm-EDTMP (higher dose) | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00245011 |
[
3,
4
] | 162 | RANDOMIZED | FACTORIAL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The proposed project is written as a "typical clinical practice" test and is a fully-controlled trial of a combined anxiety-focused CBT and pharmacotherapy (venlafaxine; CBT-VEN) delivered for patients with comorbid alcohol-use and anxiety disorders. The CBT and pharmacotherapy will be contrasted with relaxation traini... | Difficulties in anxiety management are frequent causes of relapse to alcohol use. Empirical data support the role of anxiety in alcohol relapse, and both psychosocial and pharmacological treatments for alcohol problems increasingly address the role of negative affect in alcohol-use disorders. Due to the lack of large, ... | Alcohol-Related Disorders Anxiety Disorders | Venlafaxine Alcoholism Anxiety Disorders Alcohol-Use Disorders Alcohol Abuse Alcohol Dependence Cognitive Behavioral Treatment | null | 4 | arm 1: CBT is Cognitive Behavioral Treatment which will be tailored to participants. Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week me... | [
0,
1,
1,
2
] | 4 | [
0,
5,
10,
10
] | intervention 1: Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper. intervention 2: CBT is Cognitive Behavioral Therapy. ... | intervention 1: Venlafaxine intervention 2: CBT intervention 3: Progressive muscle relaxation therapy (PMR) intervention 4: Placebo medication | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00248612 |
[
4
] | 204 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following ischemic stroke. | null | Stroke, Acute Neurological Impairment | null | 2 | arm 1: EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).
The test treatment consists of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid durin... | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months. intervention 2: Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months. intervention 3: Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months. | intervention 1: EGb761 intervention 2: Placebo intervention 3: Acetylsalicylic acid | 10 | Hradec Králové | N/A | Czechia | 15.83277 | 50.20923
Prague | N/A | Czechia | 14.42076 | 50.08804
Katowice | N/A | Poland | 19.02754 | 50.25841
Krakow | N/A | Poland | 19.93658 | 50.06143
Warsaw | N/A | Poland | 21.01178 | 52.22977
Bucharest | N/A | Romania | 26.10626 | 44.43225
Bucharest | N/A | Romania | 26.10626 | 4... | 0 | NCT00276380 | |
[
4
] | 91 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | We hypothesize that intranasal steroid application will have a beneficial therapeutic effect in adults with regard to resolution of serous otitis media and/or negative middle ear pressure, as compared to placebo. We further hypothesize that the rate of spontaneous short-term resolution of otitis media wit effusion in a... | Newer intranasal steroid preparations are generally safe with relatively few side effects as demonstrated in large studies dealing with allergic rhinitis.
Eustachian Tube Dysfunction (ETD) primarily refers to an absent or inadequate ability to open the eustachian tube. The term Serous Otitis Media (SOM) generally refe... | Otitis Media, Serous Negative Middle Ear Pressure Rhinitis Otitis Media With Effusion Otitis Media, Secretory | null | 2 | arm 1: Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.
Subjects younger than 12 years old received received 1 metered spray in each nostril once daily (55 micrograms/s... | [
1,
3
] | 2 | [
0,
0
] | intervention 1: Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms).
Subjects younger than 12 years old received received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms). interven... | intervention 1: Triamcinolone acetonide nasal spray intervention 2: Placebo nasal spray | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00279916 | |
[
3
] | 143 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpres... | null | Carcinoma, Non-Small-Cell Lung | NSCLC Erlotinib Tarceva Lung Cancer | null | 2 | arm 1: 150 mg erlotinib daily arm 2: carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: oral tablet intervention 2: IV intervention 3: IV | intervention 1: Tarceva intervention 2: carboplatin intervention 3: paclitaxel | 43 | Alhambra | California | United States | -118.12701 | 34.09529
Bakersfield | California | United States | -119.01871 | 35.37329
Concord | California | United States | -122.03107 | 37.97798
Fullerton | California | United States | -117.92534 | 33.87029
Long Beach | California | United States | -118.18923 | 33.76696
Los A... | 0 | NCT00294762 |
[
3
] | 353 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia. | null | Diabetes Mellitus | Hyperlipidemia Proteinuria Diabetes Mellitus | null | 3 | arm 1: Rosuvastatin 10 mg arm 2: Rosuvastatin 40 mg arm 3: Atorvastatin 80 mg | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 10 mg oral dose administered once daily for 52 weeks intervention 2: 20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks intervention 3: 40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once dail... | intervention 1: Rosuvastatin intervention 2: Rosuvastatin intervention 3: Atorvastatin | 116 | Avondale | Arizona | United States | -112.3496 | 33.4356
Phoenix | Arizona | United States | -112.07404 | 33.44838
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Pasadena | California | United States | -118.14452 | 34.14778
Riverside | California | United States | -117.39616 | 33.95335
Santa Ana | Californi... | 0 | NCT00296374 |
[
3
] | 60 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, su... | OBJECTIVES:
Primary
* Determine the safety of pancreatic tumor vaccine, cyclophosphamide, and cetuximab in patients with metastatic or locally advanced adenocarcinoma of the pancreas.
Secondary
* Determine the overall, progression-free, and event-free survival of patients treated with this regimen.
* Correlate spec... | Pancreatic Cancer | stage III pancreatic cancer recurrent pancreatic cancer duct cell adenocarcinoma of the pancreas adenocarcinoma of the pancreas stage IV pancreatic cancer | null | 1 | arm 1: None | [
0
] | 3 | [
0,
2,
0
] | intervention 1: Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each. intervention 2: Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles. intervention 3: Cyclophosphamide 250 m... | intervention 1: Cetuximab intervention 2: Pancreatic tumor vaccine intervention 3: Cyclophosphamide | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00305760 |
[
2
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | We are conducting a study to assess whether smoking marijuana affects the safety of prescribed opioids in patients treated for chronic pain. This study will assess whether smoking cannabis affects the absorption, distribution, metabolism and excretion of widely used opioid analgesics. We propose to do this by investiga... | Chronic pain conditions remain problematic, especially in patients with cancer. Although opioids are effective analgesics, dose-limiting side effects in the form of sedation, nausea and vomiting, and fear of dependence often limit their use at higher - and possibly more effective - doses. Of particular interest, howeve... | Pain | Cannabis Morphine Oxycodone Marijuana chronic pain | null | 1 | arm 1: None | [
5
] | 1 | [
0
] | intervention 1: None | intervention 1: Cannabis | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00308555 |
[
4
] | 1,295 | null | PARALLEL | 1PREVENTION | null | false | 0ALL | null | Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily | null | Cerebrovascular Accident | null | 2 | arm 1: None arm 2: None | [
5,
5
] | 2 | [
0,
10
] | intervention 1: extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily intervention 2: Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily | intervention 1: Aggrenox capsule intervention 2: Acetylsalicylic Acid (ASA) | 151 | Adachi-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895
Adumino, Nagano | N/A | Japan | 138.18333 | 36.65
Akashi, Hyogo | N/A | Japan | N/A | N/A
Akashi, Hyogo | N/A | Japan | N/A | N/A
Ako, Hyogo | N/A | Japan | N/A | N/A
Aoba-ku, Yokohama, Kanagawa | N/A | Japan | N/A | N/A
Aoi-ku, Shizuoka, Shizuoka | N/A | Japan | N/A... | 0 | NCT00311402 | |
[
3
] | 26 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Background:
* In a study in humans with melanoma, patients given total body irradiation to suppress the immune system in conjunction with chemotherapy showed a significant clinical response.
* In previous studies, about one-half of patients given tumor-fighting cells (cells created from the patient's tumor cells and g... | Background:
The use of immunosuppression prior to adoptive transfer of lymphocytes from tumor bearing mice was based on a variety of murine models demonstrating improved therapeutic effectiveness of the adoptive transfer of lymphocytes following immunosuppression of the host.
Because the degree of immunosuppression h... | Metastatic Melanoma | Clinical Response Stage IV Melanoma Adoptive Cell Therapy Tumor Infiltrating Lymphocytes Immunologic Response Metastatic Melanoma | null | 2 | arm 1: Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting... | [
0,
0
] | 5 | [
2,
0,
2,
0,
4
] | intervention 1: None intervention 2: 60 mg/kg/ day x 2 days intravenous intervention 3: 720,000 IU/kg/dose every 8 hours for up to 15 doses intervention 4: 25 mg/m\^2/day intravenous x 5 days intervention 5: 1200 cGY total body radiation | intervention 1: Melanoma Reactive TIL intervention 2: Cyclophosphamide intervention 3: IL-2 intervention 4: Fludarabine intervention 5: 1200 total body irradiation (TBI) | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00314106 |
[
3
] | 77 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | This study was designed to find the most effective and safest doses of both HYCAMTIN and CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN. | null | Ovarian Cancer Neoplasms, Ovarian | HYCAMTIN ovarian cancer recurrent relapsed carboplatin topotecan potentially platinum-sensitive | null | 1 | arm 1: HYCAMTIN at a dose of 2.0 - 2.5mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1, every 21 days | [
0
] | 2 | [
0,
0
] | intervention 1: HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1 intervention 2: HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1 | intervention 1: topotecan intervention 2: CARBOPLATIN | 22 | Los Angeles | California | United States | -118.24368 | 34.05223
Orange | California | United States | -117.85311 | 33.78779
Poway | California | United States | -117.03586 | 32.96282
Stanford | California | United States | -122.16608 | 37.42411
New Haven | Connecticut | United States | -72.92816 | 41.30815
Savannah | ... | 0 | NCT00316173 |
[
3
] | 31 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer patients with fluid around their lungs or abdomen. | null | Non-small Cell Lung Cancer Mesothelioma Lung Neoplasms | null | 1 | arm 1: Pemetrexed 500 mg/m\^2 intravenous (IV) every 21 days for 6 cycles | [
0
] | 1 | [
0
] | intervention 1: 500 milligrams per meter squared (mg/m\^2) IV every 21 days for 6 cycles | intervention 1: pemetrexed | 3 | Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Hanover | N/A | Germany | 9.73322 | 52.37052
Madrid | N/A | Spain | -3.70256 | 40.4165 | 0 | NCT00316225 | |
[
3
] | 7 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: 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 stopping them from dividing. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be rem... | OBJECTIVES:
Primary
* Determine whether at least 50% of patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer are able to achieve optimal cytoreduction (to \< 1 centimeter of remaining disease) after neoadjuvant chemotherapy comprising paclitaxel and carboplatin.
Secondary
*... | Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer | ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma stage III ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer fallo... | null | 1 | arm 1: All patients receiving treatment with Paclitaxel and Carboplatin followed by surgery to remove cancerous tissue. | [
0
] | 3 | [
0,
0,
3
] | intervention 1: Carboplatin dose (milligrams (mg)) - Target Area Under the Curve (AUC) 6 x (Glomerular Filtration Rate+25) - Calvert Formula, given intravenously (IV) for 30 minutes. intervention 2: Paclitaxel dose = 175 milligrams per meter squared (mg/m2) over 3 hours. intervention 3: Surgery - tumor specimen collect... | intervention 1: carboplatin intervention 2: paclitaxel intervention 3: cytoreductive surgery | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00331422 |
[
3
] | 60 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. There is limited experience with either bevacizumab or erlotinib in t... | All eligible patients will receive:
* Bevacizumab 15mg/kg IV infusion,Day 1
* Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
* Carboplatin AUC 6.0 IV Day 1
* Erlotinib 150 mg by mouth daily
The regimen will be repeated every 21 days for a total of 4 courses. Patients will be initially evaluated for response after co... | Neoplasm, Unknown Primary | Neoplasm, Unknown Primary | null | 1 | arm 1: Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 intervention 2: Carboplatin AUC 6.0 IV Day 1 intervention 3: Bevacizumab 15mg/kg IV infusion,Day 1 intervention 4: Erlotinib 150 mg by mouth daily | intervention 1: paclitaxel intervention 2: carboplatin intervention 3: bevacizumab intervention 4: erlotinib | 9 | Jacksonville | Florida | United States | -81.65565 | 30.33218
Gainesville | Georgia | United States | -83.82407 | 34.29788
Evansville | Indiana | United States | -87.55585 | 37.97476
Bowling Green | Kentucky | United States | -86.4436 | 36.99032
Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Cincinnati ... | 0 | NCT00360360 |
[
3
] | 178 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | null | RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea or polyphenon E may prevent cancer from forming in former smokers with chronic obstructive pulmonary disease.
PURPOSE: This randomized phase II trial is studying how well green tea or ... | OBJECTIVES:
Primary
* Evaluate the effects of high-level oral consumption of defined green tea (four 12-oz servings/day) or polyphenon E capsules (4 capsules/day) on markers of cellular oxidative damage, as measured by 8-hydroxydeoxyguanosine (8-OHdG) and 8-F\_2-isoprostanes (8-epi-PGF2) in former smokers with chroni... | Lung Cancer Prevention | lung cancer prevention green tea former smokers | null | 3 | arm 1: Patients receive green tea beverage and placebo capsules for 6 months. arm 2: Patients receive placebo beverage and Polyphenon E capsules daily for 6 months. arm 3: Patients receive placebo beverage and placebo capsules daily for 6 months. | [
0,
0,
2
] | 3 | [
7,
0,
10
] | intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally | intervention 1: green tea intervention 2: Polyphenon E intervention 3: placebo | 3 | Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174 | 0 | NCT00363805 |
[
3
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well PXD101 works as second-line therapy in treating patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101 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. | PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with unresectable malignant pleural mesothelioma (MPM) treated with PXD101.
SECONDARY OBJECTIVES:
I. Determine the overall survival and time to progression in these patients. II. Assess the toxicities associated with this drug in these patients... | Advanced Malignant Mesothelioma Epithelial Mesothelioma Recurrent Malignant Mesothelioma Sarcomatous Mesothelioma | null | 1 | arm 1: Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | [
0
] | 2 | [
0,
10
] | intervention 1: Given IV intervention 2: Correlative studies | intervention 1: belinostat intervention 2: laboratory biomarker analysis | 1 | Duarte | California | United States | -117.97729 | 34.13945 | 0 | NCT00365053 | |
[
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with recurrent glioblastoma multiforme or gliosarcoma. | OBJECTIVES:
Primary
* Determine the objective response rate in patients with recurrent epidermal growth factor receptor (EGFR)-positive and PTEN wild-type glioblastoma multiforme or gliosarcoma treated with erlotinib hydrochloride.
Secondary
* Assess the response rate in patients who also EGFRVIII mutant and PTEN w... | Adult Brain Tumors | adult glioblastoma adult gliosarcoma recurrent adult brain tumor | null | 1 | arm 1: During the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a me... | [
0
] | 1 | [
0
] | intervention 1: Tarceva will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day... | intervention 1: erlotinib hydrochloride | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00387894 |
[
3
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This phase II trial studies the side effects and how well sunitinib malate works in treating patients with cervical cancer which cannot be cured by standard therapy. Sunitinib malate may stop the growth of cervical cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. | PRIMARY OBJECTIVES:
I. To assess the efficacy (objective response rate) of sunitinib (sunitinib malate) given orally daily for 4 out of every 6 weeks in patients with unresectable, locally advanced or metastatic carcinoma of the cervix.
II. To assess the toxicity of sunitinib in patients with unresectable, locally ad... | Cervical Adenocarcinoma Cervical Adenosquamous Cell Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Cancer Stage IVB Cervical Cancer | null | 1 | arm 1: Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached. | [
0
] | 1 | [
0
] | intervention 1: Given PO | intervention 1: sunitinib malate | 1 | Kingston | Ontario | Canada | -76.48098 | 44.22976 | 0 | NCT00389974 | |
[
5
] | 36 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia. It is hypothesized that participants receiving eszopiclone will report greater improvement in total sleep time, sleep quality, pain, fatigue, physical functioning, and emotional distress than will thos... | Fibromyalgia (FM) is a prevalent, debilitating, and costly syndrome. Although the pathophysiology of FM is not yet well-understood, sleep disturbance is a prominent feature of most theories. Eszopiclone has been approved by the FDA for the treatment of insomnia, but has not been studied in the treatment of FMS. The pur... | Fibromyalgia Insomnia | Fibromyalgia Insomnia Sleep Eszopiclone Lunesta | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 3mg qpm for 12 weeks intervention 2: 1 pill qpm for 12 weeks | intervention 1: Eszopiclone intervention 2: placebo | 1 | Piscataway | New Jersey | United States | -74.39904 | 40.49927 | 0 | NCT00392041 |
[
4
] | 270 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to eith... | Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (... | Smokeless Tobacco Use | Tobacco use disorder Tobacco cessation | null | 2 | arm 1: 4 mg nicotine lozenges for 3 months arm 2: Placebo nicotine lozenges for 3 months | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Nicotine lozenges, 4 mg intervention 2: Placebo lozenge | intervention 1: Nicotine Lozenges intervention 2: Placebo lozenge | 2 | Rochester | Minnesota | United States | -92.4699 | 44.02163
Eugene | Oregon | United States | -123.08675 | 44.05207 | 0 | NCT00392379 |
[
5
] | 302 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administrati... | null | Diabetes Mellitus, Type 2 | diabetes type 2 | null | 2 | arm 1: Three times per day subcutaneous injection of insulin lispro mid mixture (MM) with the possibility to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved. arm 2: Twice daily subcutaneous injection of either insulin biphasic aspart 30/70 or insulin... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks intervention 2: Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose... | intervention 1: Insulin Biphasic Aspart 30/70 intervention 2: insulin lispro LM intervention 3: insulin lispro MM intervention 4: insulin lispro LM | 9 | Zagreb | N/A | Croatia | 15.97798 | 45.81444
Bialystok | N/A | Poland | 23.16433 | 53.13333
Rzeszów | N/A | Poland | 21.99901 | 50.04132
Bucharest | N/A | Romania | 26.10626 | 44.43225
Kempton Park | N/A | South Africa | 28.2377 | -26.10859
Kenilworth | N/A | South Africa | 28.04731 | -26.24709
Kuilsriver | N/A | South... | 0 | NCT00393705 |
[
2,
3
] | 49 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y. | null | Iron Overload Hereditary Hemochromatosis | Deferasirox ICL670A Iron chelators Deferiprone Transfusional Hemochromatosis | null | 1 | arm 1: Three dose cohorts: 5 mg/kg/day, 10 mg/kg/day, 15 mg/kg/day | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Deferasirox (ICL670) | 18 | Long Beach | California | United States | -118.18923 | 33.76696
Farmington | Connecticut | United States | -72.83204 | 41.71982
Detroit | Michigan | United States | -83.04575 | 42.33143
Rochester | Minnesota | United States | -92.4699 | 44.02163
St Louis | Missouri | United States | -90.19789 | 38.62727
Rochester | New... | 0 | NCT00395629 |
[
2
] | 21 | NON_RANDOMIZED | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to assess the tolerability and safety of HKI-272, and to determine the maximum dose that can safety be given. The secondary purpose of this study is to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is effective for the treatment of advanced solid tumors. | This is a phase 1 open-label sequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors. Each subject will participate in only 1 dose group and will receive a single dose of test article, followed by a 1-week observation period, and then will receive the test ... | Tumors | Advanced Malignant Solid Tumors HKI-272 Neratinib Nerlynx | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: HKI-272 | intervention 1: neratinib | 2 | Koto | Tokyo | Japan | N/A | N/A
Shizuoka | N/A | Japan | 138.38333 | 34.98333 | 0 | NCT00397046 |
[
0
] | 10 | NON_RANDOMIZED | CROSSOVER | 9OTHER | 2DOUBLE | true | 0ALL | false | This is a pilot study in which our intent is to establish an alcohol administration laboratory in which we will be able to test the effect of the anticonvulsant medication zonisamide as compared to placebo on alcohol self administration and on cognitive functioning in non treatment seeking heavy users of alcohol. Our f... | In preclinical studies three novel anticonvulsants have been studied. The administration of tiagabine did not decrease ethanol consumption in rodents (Schmitt et al., 2002; Rimondini et al., 2002). In a study with alcohol preferring mice topiramate reduced alcohol consumption in a two bottle choice prolonged access mod... | Alcoholism | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: zonisamide (100 mg)one time intervention 2: Placebo Comparator | intervention 1: zonisamide intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00398918 | |
[
5
] | 255 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability. | null | Schizophrenia Schizoaffective Disorder | ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder | null | 1 | arm 1: atypical antipsychotic for the treatment of schizophrenia | [
5
] | 1 | [
0
] | intervention 1: Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase | intervention 1: ziprasidone | 40 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Costa Mesa | California | United States | -117.91867 | 33.64113
Garden Grove | California | United States | -117.94145 | 33.77391
National City | California | United States | -117.0992 | 32.67811
Orange | California | United States | -117.85311 | 33.78779
San Di... | 0 | NCT00406315 |
[
4
] | 49 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | We wish to evaluate the effect of long term treatment with a DPP-IV inhibitor on the function of the incretin hormones
Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by DPP-IV inhibitor (Januvia®) treatment significantly ameliorates the impaired secretion and potency of GLP-1 an... | Background The incretin effect, primarily mediated by the peptide hormones GIP and GLP-1, is known to be impaired in patients with type 2 diabetes, and characterised by reduced GLP-1 secretion and potency and a lack of responsiveness to the insulinotropic effect of GIP. The cause of this defect remains unknown, but exo... | Type 2 Diabetes | GLP-1 GIP Incretin hormones DPP-IV inhibitor Hyperglycaemic clamp Meal test | null | 2 | arm 1: Placebo treatment, administered as tablets. arm 2: Active treatment | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 200 mg t.i.d intervention 2: Placebo | intervention 1: Januvia intervention 2: Placebo | 1 | Hellerup | N/A | Denmark | 12.57093 | 55.73204 | 0 | NCT00411411 |
[
3
] | 199 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy. | null | Colorectal Cancer | Colorectal cancer metastatic colorectal adenocarcinoma anti-EGFR antibody | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 1 | [
0
] | intervention 1: Everolimus was supplied in 5 mg tablets in blister packs. | intervention 1: Everolimus (RAD001) | 1 | Las Vegas | Nevada | United States | -115.13722 | 36.17497 | 0 | NCT00419159 |
[
5
] | 300 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region. | null | Rheumatoid Arthritis | null | 2 | arm 1: Etanercept + Methotrexate arm 2: DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide | [
1,
1
] | 2 | [
0,
0
] | intervention 1: * Etanercept: 25 mg twice weekly over 16 weeks, SC
* Methotrexate: \> 7.5 mg/week and no more than 25 mg/week, PO intervention 2: * Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO
* Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max... | intervention 1: Etanercept , Methotrexate intervention 2: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide | 27 | Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832
Bangalore | N/A | India | 77.59369 | 12.97194
Bangalore | N/A | India | 77.59369 | 12.97194
Hyderabaad | N/A | India | N/A | N/A
New Delhi | N/A | India | 77.2148 | 28.62137
Ipoh, Perak | N/A | Malaysia | N/A | N/A
Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412
Pul... | 0 | NCT00422227 | |
[
3
] | 36 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This Phase 2 study was to determine the incidence of increased serum aminotransferase concentrations (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]), as well as the overall safety and tolerability of ambrisentan, in participants with pulmonary arterial hypertension (PAH), idiopathic PAH (IP... | null | Pulmonary Hypertension | null | 0 | null | null | 1 | [
0
] | intervention 1: All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg). | intervention 1: ambrisentan | 0 | null | 0 | NCT00423592 | |
[
3
] | 86 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | true | The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane. | null | Breast Cancer | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 1125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease intervention 2: oral, daily, 21-day cycles until progressive disease intervention 3: 1250 mg/m\^2, BID, days 1-14 of each 21-day cycle until progressive disease | intervention 1: enzastaurin intervention 2: placebo intervention 3: capecitabine | 20 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Resistencia | N/A | Argentina | -58.98665 | -27.46363
Tucumain | N/A | Argentina | N/A | N/A
Garran | Australian Capital Territory | Australia | 149.10846 | -35.34206
Caringbah | New South Wales | Australia | 151.12468 | -34.03534
Wollongong | New South Wales | Aus... | 0 | NCT00437294 | |
[
4
] | 430 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week | A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin. Anemia is associated with decreased oxygen delivery and utilization, and can result in fatigue, lethargy, decreased cognition and mental acuity, and cardiac complications.This study was designed to compare 2 dosing regimens... | Anemia Renal Diseases | Anemia Reduction in the number of erythrocytes Hemoglobin low level Red blood cell deficiency Procrit Epoetin alfa Chronic kidney disease | null | 3 | arm 1: epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks arm 2: epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk arm 3: epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Continue pre-study once weekly dose of epoetin alfa for 36 weeks intervention 2: Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks intervention 3: Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk | intervention 1: epoetin alfa intervention 2: epoetin alfa intervention 3: epoetin alfa | 66 | Chula Vista | California | United States | -117.0842 | 32.64005
Fountain Valley | California | United States | -117.95367 | 33.70918
Los Angeles | California | United States | -118.24368 | 34.05223
Lynwood | California | United States | -118.21146 | 33.93029
Orange | California | United States | -117.85311 | 33.78779
R... | 0 | NCT00440466 |
[
3
] | 54 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To allow open-label extension to patients who have completed Protocol 1042-0500 | Patient should have completed all scheduled clinical study visits in the double blind, controlled trial (Protocol 1042-0500) and have been deemed eligible (had a response to treatment) by the Investigator. Male or female, with a diagnosis of IS with a video EEG (vEEG) recording confirming the diagnosis.
There will be ... | Infantile Spasms | infantile spasms anticonvulsant pediatric epilepsy West Syndrome epileptic spasms | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Ganaxolone | 14 | Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Miami | Florida | United States | -80.19366 | 25.77427
Pensacola | Florida | United States | -87.21691 | 30.4213... | 0 | NCT00442104 |
[
3
] | 1 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Systemic lupus erythematosus (SLE) is a chronic, multisystem, autoimmune disease in which the body's immune system attacks its own normal tissues. This abnormal autoimmune response can result in damage to many parts of the body, including the skin, joints, lungs, heart, brain, intestines, and kidneys. Kidney problems o... | Kidney problems associated with lupus nephritis range from asymptomatic protein in the urine to rapidly progressive glomerulonephritis, leading to end-stage renal disease. The goal of therapies is to control kidney manifestations in order to avoid kidney failure, the occurrence of other medical problems and death.
The... | Lupus Nephritis | null | 2 | arm 1: Participants in this group will self-administer 50 mg etanercept injections once a week for 24 weeks. They will continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil (MMF), mycophenolic acid, or azathioprine (AZA). arm 2: Participants in this group will self-administer 50... | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 1.) Immune suppressant. 2.) Tumor necrosis factor (TNF) inhibitor. intervention 2: Individualized standard of care treatment for lupus with corticosteroids and with mycophenolate mofetil (MMF), mycophenolic acid, or azathioprine (AZA) intervention 3: None | intervention 1: Etanercept intervention 2: Lupus Treatment- Standard of Care intervention 3: Placebo | 6 | Birmingham | Alabama | United States | -86.80249 | 33.52066
San Francisco | California | United States | -122.41942 | 37.77493
Aurora | Colorado | United States | -104.83192 | 39.72943
Manhasset | New York | United States | -73.69957 | 40.79788
Rochester | New York | United States | -77.61556 | 43.15478
Durham | North ... | 0 | NCT00447265 | |
[
3
] | 84 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate the safety and effectiveness of four dose regimens (pattern of giving treatment) of JNJ-26113100 in the treatment of adult Atopic Dermatitis (\[AD\]; skin rash, inflammation) that is moderate in severity. | This study is a double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study drug assigned by chance), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the ... | Atopic Dermatitis | Atopic Dermatitis JNJ-26113100 | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
2,
0,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Matching placebo capsules to JNJ-26113100 (50 milligram \[mg\]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily or 250 mg orally twice daily for 6 weeks. intervention 2: JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks. intervention 3: JNJ-26113100 (100 mg) capsules... | intervention 1: Placebo intervention 2: JNJ-26113100 (50 mg) once daily intervention 3: JNJ-26113100 (100 mg) once daily intervention 4: JNJ-26113100 (100 mg) twice daily intervention 5: JNJ-26113100 (250 mg) twice daily | 19 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Stanford | California | United States | -122.16608 | 37.42411
Vista | ... | 0 | NCT00455429 |
[
3
] | 11 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes. | A large study in people with type 1 diabetes (T1DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugars as near to normal as safely possible.
In people without diabetes, the "after meal" blood sugar level is very... | Type 1 Diabetes | Hypoglycemia Hyperglycemia | null | 3 | arm 1: In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection arm 2: In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection arm 3: Each subject received a baselin... | [
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide. intervention 2: Each subject received a baseline study with insulin alone | intervention 1: Exenatide intervention 2: Insulin | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00456300 |
[
4
] | 287 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease w... | The objective of this trial is to assess the effects of rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evalu... | Parkinson's Disease | rotigotine Neupro® Parkinson's Disease | null | 2 | arm 1: Rotigotine transdermal patch arm 2: Placebo transdermal patch | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Rotigotine transdermal patches:
10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)
Optimal dosing: The maximum Rotigotine dose allowed is 16mg/24h intervention 2: Placebo transdermal patches | intervention 1: Rotigotine intervention 2: Placebo | 47 | Reseda | California | United States | -118.53647 | 34.20112
Ventura | California | United States | -119.29317 | 34.27834
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Salisbury | North Carolina | United States | -80.47423 | 35.67097
Winston_Salem | North Carolina | United States | N/A | N/A
Warwick | ... | 0 | NCT00474058 |
[
5
] | 463 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes | null | Genital Herpes | Recurrent genital herpes Black population | null | 2 | arm 1: Famciclovir 1000 mg; twice a day for one day. arm 2: Placebo; twice a day for one day. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: oral; two 500 mg tablets twice a day; single day treatment intervention 2: oral; two tablets twice a day; single day treatment | intervention 1: Famciclovir intervention 2: Placebo | 43 | Burbank | California | United States | -118.30897 | 34.18084
Huntington Park | California | United States | -118.22507 | 33.98168
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Hollywood | Florida | United States | -80.14949 | 26.0112
... | 0 | NCT00477334 |
[
5
] | 300 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 3TRIPLE | true | 0ALL | false | Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objectiv... | Participants must be scheduled for a CT scan prior to enrollment in this study. Informed consent will be obtained from patients acceptable to be included in the study. It will be noted if there is a history of gastrointestinal surgery and if the patient is nauseated before the contrast is administered.
Patients will b... | Healthy | CT scan oral contrast | null | 2 | arm 1: Gastroview arm 2: Omnipaque | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Oral CT contrast intervention 2: Oral CT contrast | intervention 1: Omnipaque intervention 2: Gastroview | 1 | Birmingham | Alabama | United States | -86.80249 | 33.52066 | 0 | NCT00478556 |
[
4
] | 945 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.
To evaluate safety and tolerability of flibanserin in such patients. | null | Sexual Dysfunctions, Psychological | null | 3 | arm 1: 50 mg qhs arm 2: 100 mg qhs arm 3: placebo qhs | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: flibanserin 50 mg intervention 2: flibanserin 100mg intervention 3: placebo | intervention 1: 50 mg qhs intervention 2: 100 mg intervention 3: placebo | 86 | Innsbruck | N/A | Austria | 11.39454 | 47.26266
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Wörgl | N/A | Austria | 12.06174 | 47.48906
Braine-l'Alleud | N/A | Belgium | 4.36784 | 50.68363
Edegem | N/A | Belgium | 4.44504 | 51.15... | 0 | NCT00491829 | |
[
5
] | 31 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | Many individuals with schizophrenia also suffer from marijuana addiction. Clozapine, an atypical antipsychotic medication, may prove useful at preventing drug relapse in schizophrenic individuals who are seeking treatment for marijuana addiction. The purpose of this study is to compare the effectiveness of clozapine, v... | Individuals with schizophrenia have a high risk of becoming addicted to drugs; between 13 to 42% of schizophrenics are addicted to marijuana. These individuals often have difficulties adhering to a substance abuse treatment program, and have an increased chance of marijuana relapse. Marijuana use by schizophrenics has ... | Schizophrenia Dual Diagnosis Schizoaffective Disorder Psychotic Disorder Cannabis Abuse | Clozapine Schizophrenia Dual Diagnosis Substance Abuse Cannabis Abuse | null | 2 | arm 1: Clozapine, Clozaril arm 2: Treatment as usual with any antipsychotic other than Clozapine. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Clozapine up to 550mg per day intervention 2: Remain on pre-study antipsychotic treatment | intervention 1: Clozapine intervention 2: Treatment as usual | 4 | Los Angeles | California | United States | -118.24368 | 34.05223
Kansas City | Missouri | United States | -94.57857 | 39.09973
Manchester | New Hampshire | United States | -71.45479 | 42.99564
Columbia | South Carolina | United States | -81.03481 | 34.00071 | 0 | NCT00498550 |
[
3
] | 25 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days. | null | Disseminated Intravascular Coagulation | DIC associated with severe sepsis | null | 3 | arm 1: Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175% arm 2: Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275% arm 3: The best standard treatment for the underlying condit... | [
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Antithrombin alfa (INN name) intervention 2: Control (Standard treatment) | 0 | null | 0 | NCT00506519 |
[
5
] | 125 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | 258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or quetiapine in the treatment of schizophrenia and currently presenting with metabolic syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a range of 10 to 30 mg once daily (QD); or ii) con... | null | Metabolic Syndrome Schizophrenia | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, 5 to 30 mg, once daily, 16 weeks intervention 2: Tablets, Oral, According to summary of product characteristics (SmPC) | intervention 1: Aripiprazole intervention 2: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine) | 30 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Brno | N/A | Czechia | 16.60796 | 49.19522
Brno | N/A | Czechia | 16.60796 | 49.19522
Havířov | N/A | Czechia | 18.43688 | 49.77984
Hradec Králové | N/A | Czechia | 15.83277 | 50.20923
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804... | 0 | NCT00508157 | |
[
3
] | 243 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. | null | Choroidal Neovascularization Age-Related Maculopathy | null | 2 | arm 1: Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14. arm 2: Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14. | [
0,
3
] | 3 | [
0,
2,
10
] | intervention 1: Intravitreal injection of dexamethasone 700 µg at Day 1. intervention 2: Ranibizumab 500 µg at day -30 and Day 7-14. intervention 3: Sham needle-less injection administered in the study eye at Day 1. | intervention 1: dexamethasone intervention 2: ranibizumab intervention 3: sham | 9 | Boynton Beach | Florida | United States | -80.06643 | 26.52535
Parramatta | New South Wales | Australia | 151.00348 | -33.8178
Paris | N/A | France | 2.3488 | 48.85341
Tel Aviv | N/A | Israel | 34.78057 | 32.08088
Milan | N/A | Italy | 12.59836 | 42.78235
Auckland | N/A | New Zealand | 174.76349 | -36.84853
Coimbra | N... | 0 | NCT00511706 | |
[
3
] | 5 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus methotrexate (8g/m2 iv) given at intervals up to... | null | Lymphoma | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 750mg/m2 iv intervention 2: 8g/m2 iv intervention 3: 2g/m2 iv | intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate intervention 3: Cytarabine | 2 | Greenfield Park | Quebec | Canada | -73.46223 | 45.48649
Québec | Quebec | Canada | -71.21454 | 46.81228 | 0 | NCT00517699 | |
[
4
] | 201 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to evaluate the efficacy, safety, and tolerability of 3 weight-based, fixed-dose groups of paliperidone extended release (ER) compared with placebo in adolescent patients between 12 to 17 years of age, who are diagnosed with schizophrenia. Paliperidone ER is an atypical antipsychotic agent ... | The study is a multicenter, randomized (treatment group is assigned by chance), double-blind (neither the physician nor the patient knows which treatment group the patient is in), parallel-group, placebo controlled study. This study will enroll adolescent men and women who have schizophrenia as specified by the Diagnos... | Schizophrenia | Schizophrenia Antipsychotic | null | 4 | arm 1: Paliperidone ER 1.5 mg tablet once daily for 6 weeks arm 2: Paliperidone ER 3 mg or 6 mg tablet once daily for 6 weeks arm 3: Paliperidone ER 6 mg or 12 mg tablet once daily for 6 weeks arm 4: Placebo Once daily for 6 weeks | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 3 mg or 6 mg tablet once daily for 6 weeks intervention 2: Once daily for 6 weeks intervention 3: 1.5 mg tablet once daily for 6 weeks intervention 4: 6 mg or 12 mg tablet once daily for 6 weeks | intervention 1: Paliperidone ER intervention 2: Placebo intervention 3: Paliperidone ER intervention 4: Paliperidone ER | 34 | Cerritos | California | United States | -118.06479 | 33.85835
Fountain Valley | California | United States | -117.95367 | 33.70918
San Diego | California | United States | -117.16472 | 32.71571
Santa Ana | California | United States | -117.86783 | 33.74557
Washington D.C. | District of Columbia | United States | -77.03... | 0 | NCT00518323 |
[
5
] | 249 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder. | null | Sleep Disorders Obstructive Sleep Apnea Major Depressive Disorder Dysthymic Disorder | Obstructive Sleep Apnea/Hypopnea Syndrome Excessive Sleepiness | null | 2 | arm 1: armodafinil 200 mg/day arm 2: Placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 200 mg/day intervention 2: placebo | intervention 1: armodafinil intervention 2: placebo | 62 | Jasper | Alabama | United States | -87.27751 | 33.83122
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Glendale | California | United States | -118.25508 | 34.14251
Glendale | California | Unite... | 0 | NCT00518986 |
[
0
] | 218 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 4QUADRUPLE | false | 0ALL | false | This study will test the hypothesis that ropivacaine in combination with either systemic or local steroid provides comparably longer-lasting analgesia tha ropivacaine alone. | This study proposes to recruit 120 patients who are undergoing open shoulder surgery. Patients will be identified preoperatively by means of the surgical schedule at each participating location. Randomization will be generated by a web-based system and stratified by hospital. The attending physician will be blinded to ... | Pain | Interscalene nerve block Dexamethasone Ropivacaine | null | 4 | arm 1: Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block arm 2: Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic ... | [
2,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 30 ml 0.5% intervention 2: 8 mg (2 ml) intervention 3: 30 ml 0.5% intervention 4: 0.9% saline; systemic and local | intervention 1: Ropivacaine intervention 2: dex intervention 3: Bupivacaine intervention 4: Saline | 2 | Cleveland | Ohio | United States | -81.69541 | 41.4995
Euclid | Ohio | United States | -81.52679 | 41.5931 | 0 | NCT00519584 |
[
5
] | 672 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers, preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation of MF DPI 200 mcg twice daily in corticost... | null | Asthma | null | 3 | arm 1: 2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks arm 2: 1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 we... | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Mometasone furoate dry powder inhaler intervention 2: Placebo | 0 | null | 0 | NCT00521599 | |
[
3
] | 5 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive, which will allow for detection of tumor and make further ablation treatment effective. | PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with thyroid cancers that do not respond well to other treatments. | Head and Neck Cancer | null | 2 | arm 1: If a patient exhibits increased radioiodine uptake on the Thyrogen scan post valproic acid therapy, patients will then prepare for ablative treatment and will remain on valproic acid for a total of 16 weeks, until receiving RAI ablation. arm 2: If no increased uptake is seen, patients will continue on valproic a... | [
5,
5
] | 1 | [
0
] | intervention 1: OUTLINE: This is a pilot study.
Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic aci... | intervention 1: Valproic Acid | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00525135 | |
[
4
] | 253 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 2MALE | false | This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase | null | Benign Prostatic Hyperplasia Prostatic Hyperplasia | placebo control Chinese Dutasteride Randomized Benign Prostatic Hyperplasia Double blind | null | 2 | arm 1: dutasteride 0.5mg once daily orally arm 2: Placebo matched once daily orally | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Dutasteride 0.5mg once daily orally intervention 2: Dutasteride matched placebo once daily orally | intervention 1: Dutasteride 0.5mg capsule intervention 2: Dutasteride matched placebo | 12 | Guangzhou | Guangdong | China | 113.25 | 23.11667
Wuhan | Hubei | China | 114.26667 | 30.58333
Nanjing | Jiangsu | China | 118.77778 | 32.06167
Hangzhou | Zhejiang | China | 120.16142 | 30.29365
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 3... | 0 | NCT00527605 |
[
4
] | 239 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study uses an open-label design and will be conducted in approximately 60 sites aiming to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12 months exposure to PN400 (VIMOVO). | PN400 is proposed for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 12 months in patients at risk for developing NSAID-associated gastric ulcers. This study is designed to provid... | Gastric Ulcer | osteoarthritis rheumatoid arthritis ankylosing spondylisit NSAIDS | null | 1 | arm 1: 500 mg delayed release naproxen/20 mg immediate release esomeprazole | [
0
] | 2 | [
0,
0
] | intervention 1: Subjects are instructed to take 2 tablets a day, one in the morning and one in the afternoon/evening. The morning tablet should be taken with water, on an empty stomach 30 to 60 minutes before breakfast, or the first meal. The afternoon/evening tablet should be taken with water, on an empty stomach 30 t... | intervention 1: PN400 (VIMOVO) intervention 2: PN 400 (VIMOVO) | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00527904 |
[
3
] | 123 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their ... | null | Coronary Artery Disease | Coronary artery disease CAD heart attack stable angina Stable coronary artery disease | null | 3 | arm 1: Aspirin + Placebo arm 2: Aspirin + clopidogrel arm 3: Aspirin + Ticagrelor | [
1,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD) intervention 2: Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD) intervention 3: Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant t... | intervention 1: Ticagrelor Tablets intervention 2: Clopidogrel (over encapsulated) capsule intervention 3: Aspirin Tablets | 9 | Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Baltimore | Maryland | United States | -76.61219 | 39.29038
Towson | Maryland | United States | -76.60191 | 39.4015
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Philadelphia | Penns... | 0 | NCT00528411 |
[
3
] | 52 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | This Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover, pharmacokinetic (PK) study will compare plasma concentrations of BH4 in subjects with endothelial dysfunction following 14 days of treatment by each of 2 regimens: sapropterin dihydrochloride with vitamin C and sapropterin dihydrochlorid... | This was a Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover, pharmacokinetic (PK) study designed to compare the plasma concentrations of BH4 in subjects with endothelial dysfunction following 14 days of treatment by each of 2 regimens: sapropterin dihydrochloride with vitamin C and sapropter... | Endothelial Dysfunction | 6R-BH4 BH4 BH4 deficiency sapropterin dihydrochloride endothelial dysfunction NO Hypertension Nitric Oxide Vitamin C | null | 2 | arm 1: Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28. arm 2: Sapropterin dihydrochloride 5 mg/kg and 500 mg Vitamin C twice a day administered as who... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Sapropterin Dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28. intervention 2: Sapropterin Dihydrochloride 5 mg/kg and 500 mg Vitamin C twice a day a... | intervention 1: Sapropterin Dihydrochloride intervention 2: Sapropterin Dihydrochloride and Vitamin C | 1 | Hackensack | New Jersey | United States | -74.04347 | 40.88593 | 0 | NCT00532844 |
[
3
] | 23 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with and without darunavir/ritonavir 800/100 mg once daily in HIV-1 infected, antiretroviral (ARV) naÃ-ve patients (patients who have never re... | This is a multi-center, open-label (doctors and patients know which drug is being given), Phase IIa clinical trial to evaluate the pharmacokinetic (PK) profile, safety and tolerability of TMC125 dosed once daily with tenofovir/emtricitabine with and without darunavir/ritonavir in antiretroviral naive HIV-1 infected pat... | HIV-1 Infection | HIV AIDS Immunodeficiency Virus, Human PREZISTA darunavir TMC114 TMC125 Protease Inhibitor Non-Nucleoside Reverse Transcriptase Inhibitor Truvada Treatment Naive | null | 1 | arm 1: TMC125; darunavir; ritonavirTMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks | [
0
] | 1 | [
0
] | intervention 1: TMC125 400mg once daily for 4 weeks; Darunavir-800mg once daily for 48 weeks; Ritonavir-100mg once daily for 48 weeks | intervention 1: TMC125; darunavir; ritonavir | 0 | null | 0 | NCT00534352 |
[
4
] | 1,289 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease. | null | Hypercholesterolemia | High Cholesterol | null | 5 | arm 1: Each patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. arm 2: Each patient will receive 1 active treatm... | [
0,
0,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks intervention 2: Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks intervention 3: Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for ... | intervention 1: Atorvastatin 10 mg intervention 2: Ezetimibe 10 mg/simvastatin 20 mg intervention 3: Atorvastatin 20 mg intervention 4: Ezetimibe 10 mg/simvastatin 40 mg intervention 5: Atorvastatin 40 mg | 0 | null | 0 | NCT00535405 |
[
4
] | 43 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects. | null | Candidemia | null | 1 | arm 1: This is an open-label, multi-center, non-comparative 12 week study evaluating the efficacy and safety of anidulafungin in subjects with candidemia. | [
5
] | 1 | [
0
] | intervention 1: Eligible subjects will be initiated on a single loading dose of 200 mg IV anidulafungin, followed by 100 mg IV anidulafungin once daily for a minimum of 5 days but not more than 42 days. | intervention 1: Anidulafungin | 13 | Ahmedabad | Gujarat | India | 72.58727 | 23.02579
Bangalore | Karnataka | India | 77.59369 | 12.97194
Mumbai | Maharashtra | India | 72.88261 | 19.07283
Ludhiana | Punjab | India | 75.85379 | 30.91204
Noida | Uttar Pradesh | India | 77.33 | 28.58
Legaspi Village, Makati City | N/A | Philippines | 121.03269 | 14.55027
B... | 0 | NCT00537329 | |
[
5
] | 25 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact i... | null | Diabetes Diabetes Mellitus, Type 1 | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart intervention 2: Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir intervention 3: Treat-to-target... | intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: insulin detemir intervention 4: insulin aspart | 1 | Paris | N/A | France | 2.3488 | 48.85341 | 0 | NCT00542620 | |
[
3
] | 17 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | 1\) To examine the efficacy of rimonabant in decreasing weight and metabolic parameters/cardiovascular disease risk in people with schizophrenia receiving second generation antipsychotics 2) To examine the safety and tolerability of rimonabant as an adjunctive agent for decreasing weight and metabolic risk in people wi... | Part I will be a 2-week evaluation phase. In Part I, subjects undergo a diagnostic interview for symptoms and treatment along with medical, side effect measures, and neuropsychological tests (tests for memory, attention, and motor task skills). An electrocardiogram (EKG), a urine sample, and about 3 tablespoons of bloo... | Schizophrenia Schizoaffective Disorder Obesity Hypertension Smoking | Metabolic abnormalities Safety Satiety | null | 2 | arm 1: Rimonabant arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: One 20 mg tablet given 1 time per day for 112 days. intervention 2: One placebo tablet given 1 time per day for 112 days. | intervention 1: Rimonabant intervention 2: Placebo | 4 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Baltimore | Maryland | United States | -76.61219 | 39.29038
Baltimore | Maryland | United States | -76.61219 | 39.29038
Catonsville | Maryland | United States | -76.73192 | 39.27205 | 0 | NCT00547118 |
[
4
] | 57 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia. | Subjects will be randomized, with stratification by baseline sodium \<130 or ≥ 130 mEq/L\[mmol/L\] to receive either tolvaptan 15 mg tablet or matching placebo tablet at doses of 15, 30 or 60 mg for 21 days. During this period, fluid restrictions should be loosened or suspended, until the subject's response to therapy ... | Hyponatremia | Hyponatremia Cognitive Neurological Function Elderly | null | 2 | arm 1: Placebo tablet given once a day for 21 days arm 2: Tolvaptan 15 mg-60 mg tablet given once a day for 21 days. | [
2,
1
] | 2 | [
0,
0
] | intervention 1: 15-60 mg oral tablet given once a day for 21 days. intervention 2: Placebo tablet given once daily for 21 days | intervention 1: Tolvaptan intervention 2: Placebo | 12 | Hawthorne | California | United States | -118.35257 | 33.9164
Vista | California | United States | -117.24254 | 33.20004
Colorado Springs | Colorado | United States | -104.82136 | 38.83388
Largo | Florida | United States | -82.78842 | 27.90979
Punta Gorda | Florida | United States | -82.04537 | 26.92978
Conyers | Georg... | 0 | NCT00550459 |
[
4
] | 339 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy. | null | Diabetic Neuropathies | null | 3 | arm 1: duloxetine 60 milligram (mg) taken orally every day arm 2: Duloxetine 40 mg taken orally every day arm 3: placebo comparator taken orally every day | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: duloxetine 40 mg taken orally every day intervention 2: placebo taken orally every day intervention 3: duloxetine 60 mg taken orally every day | intervention 1: Duloxetine hydrochloride - 40 mg intervention 2: placebo intervention 3: Duloxetine hydrochloride - 60 mg | 25 | Aichi | N/A | Japan | 130.62158 | 32.51879
Aomori | N/A | Japan | 140.73333 | 40.81667
Chiba | N/A | Japan | 140.11667 | 35.6
Fukui | N/A | Japan | 135.54836 | 34.84214
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukushima | N/A | Japan | 140.46667 | 37.75
Gunma | N/A | Japan | N/A | N/A
Hiroshima | N/A | Japan | 132.45 |... | 0 | NCT00552175 | |
[
4
] | 314 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy. | null | Diabetic Neuropathy, Painful | null | 3 | arm 1: None arm 2: None arm 3: None | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose) intervention 2: Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose) intervention 3: Dosage: 600 mg/day (300 mg bid), oral ... | intervention 1: placebo intervention 2: pregabalin intervention 3: pregabalin | 49 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Chikushino-shi | Fukuoka | Japan | 130.5156 | 33.49631
Kasuga | Fukuoka | Japan | 130.4611 | 33.52594
Date-shi | Fukushima | Japan | N/A | N/A
Nihommatsu | Fukushima | Japan | 140.43333 | 37.58333
Shirakawa-shi | Fukushima | Japan | N/A | N/A
Sukagawa | Fukushima | Japa... | 0 | NCT00553475 | |
[
3
] | 71 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 1FEMALE | null | This is a Phase 2, interventional, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI). This study will compare 4 doses of the investigational drug ... | The study was terminated after Merck Serono had taken the decision not to pursue the development of AS900672-enriched in ovulation induction (OI). This decision was not related to any safety or efficacy concerns over the use of AS900672-Enriched in OI. | Ovulation Induction | Infertility Oligo-anovulation GONAL-f® AS900672-Enriched hyperglycosylated recombinant human follicle stimulating hormone (r-hFSH) | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
0,
0,
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days. intervention 2... | intervention 1: AS900672-Enriched 10 microgram (mcg) intervention 2: AS900672-Enriched 20 mcg intervention 3: AS900672-Enriched 30 mcg intervention 4: AS900672-Enriched 40 mcg intervention 5: Follitropin alfa 75 international unit (IU) intervention 6: Recombinant human chorionic gonadotropin (r-hCG) | 1 | Geneva | N/A | Switzerland | 6.14569 | 46.20222 | 0 | NCT00553514 |
[
5
] | 30 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease) patients with moderately severe disease using metronome paced hyperventilation (MPH) with inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung volume protecting inspiratory capacity from MPH... | Study completed with 29 patients studied. Data is being analyzed to evaluate trough and peak effect of 18 µg tiotropium vs placebo on FEV 1 (L)(forced expiratory capacity in one second), inspiratory capacity and functional residual volume. In addition, we will study the effect of 18 µg tiotropium vs placebo on metronom... | COPD | null | 2 | arm 1: tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo arm 2: placebo 18ug tiotropium for 1 month | [
1,
2
] | 1 | [
0
] | intervention 1: Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation | intervention 1: Placebo | 2 | Lakewood | California | United States | -118.13396 | 33.85363
Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT00569270 | |
[
3
] | 25 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma. | null | Glioblastoma Astrocytoma Oligodendroglioma Brain Tumor, Recurrent | Temozolomide Brain Tumor, Recurrent Chemotherapy | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity | intervention 1: Temozolomide | 1 | Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 | 0 | NCT00575887 |
[
3
] | 36 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer. | null | Prostate Cancer Hormonal Cycling | Prostate Cancer Hormones 01-085 ANTIFUNGAL ANTIBIOTICS ESTROGENS LUPRON TESTOSTERONE ZOLADEX | null | 1 | arm 1: None | [
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: leuprolide and goserelin are gonadotropin-releasing hormone analogues intervention 2: An imidazole antifungal agent. reduces adrenal and testicular androgen production in men intervention 3: A pure nonsteroidal antiandrogen intervention 4: an androgenic anabolic steroid intervention 5: Estradiol is the ... | intervention 1: GnRH intervention 2: Ketoconazole intervention 3: Bicalutamide intervention 4: Testosterone transdermal gel intervention 5: Estrogen transdermal patch | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00586898 |
[
3
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | In this study, we want to find out how likely it is for temozolomide to shrink melanoma tumors that have spread only to areas that could be removed by surgery. We also want to study the melanoma before and after temozolomide treatment to learn why some tumors respond and others do not. This is a Phase II trial. This me... | In this Phase II trial, chemotherapy-naïve patients with palpable Stage III or Stage IV M1a melanoma scheduled to undergo surgical resection will be treated with TMZ in 8 week cycles according to the extended dosing schedule of 75mg/m2/day x 6 weeks with 2 weeks off. Patients will be treated until maximal response to T... | Melanoma Skin Cancer Cancer | Melanoma Skin Cancer Cancer Temozolamide TMZ | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: At the start of the trial a core needle biopsy of a palpable tumor will be obtained percutaneously in the office after administration of local anesthesia. Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks. After each cycle, patients w... | intervention 1: Temozolomide | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00588341 |
[
4
] | 551 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with chlorthalidone in treating individuals with essential hypertension, compared to treatment with chlorthalidone alone. | Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause ... | Hypertension | Blood pressure Blood pressure monitoring, ambulatory | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily; azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily; and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. intervention 2: Azilsartan medoxomil 80 mg, tablets, orally, once daily; azilsartan medoxomil 40 mg p... | intervention 1: Azilsartan medoxomil and chlorthalidone intervention 2: Azilsartan medoxomil and chlorthalidone intervention 3: Chlorthalidone | 46 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Montgomery | Alabama | United States | -86.29997 | 32.36681
Buena Park | California | United States | -117.99812 | 33.86751
Huntington Beach | California | United States | -117.99923 | 33.6603
Long Beach | California | United States | -118.18923 | 33.76696
Miss... | 0 | NCT00591773 |
[
3
] | 146 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in patients with Post-Herpetic Neuralgia (PHN). | null | Neuralgia | Post-Herpetic Neuralgia PHN) | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
2,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: 2 mg titrated up to 8 mg maximum; taken once daily. intervention 2: 2 mg titrated up to 8 mg maximum; taken once daily. | intervention 1: E2007 (perampanel) intervention 2: Placebo | 47 | Peoria | Arizona | United States | -112.23738 | 33.5806
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | Calif... | 0 | NCT00592774 |
[
4
] | 439 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with Opioid-induced Bowel Dysfunction. | null | Opioid-Induced Bowel Dysfunction | null | 2 | arm 1: 0 mcg capsules twice daily (BID) arm 2: 24 mcg capsules twice daily (BID) | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 24 mcg capsules twice daily (BID) intervention 2: 0 mcg capsules twice daily (BID) | intervention 1: Lubiprostone intervention 2: Placebo | 95 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Hueytown | Alabama | United States | -86.99666 | 33.45122
Mobile | Alabama | United States | -88.04305 | 30.69436
Mesa | Arizona | United States | -111.82264 | 33.42227
Tempe | Arizona | United States | -111.90931 | 33.41477
Tucson | Arizona | United States | ... | 0 | NCT00595946 | |
[
3
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the liver and development of scarring. This condition occurs more frequently in overweight and obese persons. It is often associated with resistance to the actions of insulin hormone. Fat cells secrete a hormone called leptin. Recently... | null | Fatty Liver Disease, Nonalcoholic | Nonalcoholic fatty liver disease Insulin resistance Obesity Leptin therapy NASH | null | 1 | arm 1: Treatment group | [
0
] | 1 | [
0
] | intervention 1: 0.1 mg/kg/day once a day via subcutaneous injections | intervention 1: metreleptin | 1 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756 | 0 | NCT00596934 |
[
5
] | 18 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy res... | Corticosteroids (one specific type is prednisone) have been used in clinical transplantation for more than 30 years. There are many side effects of corticosteroids including significant bone disease, diabetes (elevated blood sugar levels), fluid retention and hypertension (high blood pressure), psychosis, peptic ulcer ... | Transplants and Implants | kidney transplantation tacrolimus Prograf mycophenolate mofetil CellCept corticosteroid withdrawal prednisone withdrawal prednisone maintenance rabbit antithymocyte globulin Thymoglobulin | null | 2 | arm 1: Participants randomized to the prednisone withdrawal group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was given intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered to participants an inpatient or outpatient... | [
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: In this group, participants had prednisone rapidly decreased until completely eliminated by day 6 after transplant. Participants began on 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 4... | intervention 1: prednisone intervention 2: rabbit antithymocyte globulin intervention 3: Tacrolimus intervention 4: Prednisone intervention 5: Mycophenolate mofetil intervention 6: Mycophenolate mofetil | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00596947 |
[
4
] | 437 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD). | null | Opioid-Induced Bowel Dysfunction | null | 2 | arm 1: 0 mcg capsules twice daily (BID) arm 2: 24 mcg capsules twice daily (BID) | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 24 mcg capsules twice daily (BID) intervention 2: 0 mcg capsules twice daily (BID) | intervention 1: Lubiprostone intervention 2: Placebo | 114 | Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United States | -111.90931 | 33.41477
Tempe | Arizona | United State... | 0 | NCT00597428 | |
[
4
] | 51 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy.
This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Following treatment and Week 28 evaluations... | Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder of lipoprotein metabolism characterized by markedly elevated low density lipoprotein (LDL), premature onset of atherosclerosis and development of xanthomata. Patients with homozygous familial hypercholesterolemia (HoFH) have a severe disease t... | Lipid Metabolism, Inborn Errors Hypercholesterolemia, Autosomal Dominant Hyperlipidemias Metabolic Diseases Hyperlipoproteinemia Type II Metabolism, Inborn Errors Genetic Diseases, Inborn Infant, Newborn, Diseases Metabolic Disorder Congenital Abnormalities Hypercholesterolemia Hyperlipoproteinemias Dyslipidemias Lipid... | Apolipoprotein B Homozygous Familial Hypercholesterolemia LDL-receptor gene | null | 2 | arm 1: Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks. arm 2: Participants received placebo as a subcutaneous injection once a week for 26 weeks. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 200 mg mipomersen administered once a week for 26 weeks as a 1 mL subcutaneous injection. Subjects weighing less than 50 kg received a lower dose of 160 mg (0.8mL) mipomersen. intervention 2: 1 mL subcutaneous injection once a week for 26 weeks. Subjects weighing less than 50 kg received 0.8 mL subcutan... | intervention 1: mipomersen intervention 2: Placebo | 10 | Charlotte | North Carolina | United States | -80.84313 | 35.22709
Cincinnati | Ohio | United States | -84.51439 | 39.12711
São Paulo | São Paulo | Brazil | -46.63611 | -23.5475
Chicoutimi | Quebec | Canada | -71.06369 | 48.41963
Ste Foy | Quebec | Canada | N/A | N/A
Mistri Wing | N/A | Singapore | N/A | N/A
Observatory... | 0 | NCT00607373 |
[
0
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | true | The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in... | Twenty (20) patients will be enrolled in this two-period crossover, randomized study design. During the course of the study, each patient will be treated with each test article in the clinic at separate visits. Following the informed consent procedure, a general ocular evaluation, including corneal and conjunctival sta... | Dry Eye Disease | Dry Eyes Tear Film Stability | null | 2 | arm 1: Artificial Tears (Optive, 40 microliters) will be administered at the first study visit, after baseline evaporation rate measurements have been taken. Evaporation rate measurements will be repeated 30 minutes later. At the next study visit, 2-14 days later, artificial tears (Systane, 40 microliters) will be admi... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: First visit: Instillation of Optive followed by evaporometry assessment after 30 minutes.
Second visit: Instillation of Systane followed by evaporometry assessment after 30 minutes. intervention 2: First visit: Instillation of Systane followed by evaporometry assessment after 30 minutes.
Second visit:... | intervention 1: 1st visit Optive, then 2nd visit Systane intervention 2: 1st visit Systane, then 2nd visit Optive | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00610480 |
[
4
] | 976 | null | null | 0TREATMENT | null | false | 0ALL | null | The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment. | null | Hypertension | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: telmisartan/amlodipine 40/5 mg fixed combination intervention 2: telmisartan/amlodipine 80/5 mg fixed combination | 122 | Aywaille | N/A | Belgium | 5.67684 | 50.47411
Gozée | N/A | Belgium | 4.35273 | 50.33461
Linkebeek | N/A | Belgium | 4.33688 | 50.76781
Mol | N/A | Belgium | 5.11662 | 51.19188
Natoye | N/A | Belgium | 5.058 | 50.34294
Tienen | N/A | Belgium | 4.9378 | 50.80745
Turnhout | N/A | Belgium | 4.94471 | 51.32254
Coquitlam | ... | 0 | NCT00614380 | |
[
0
] | 10 | NA | SINGLE_GROUP | null | 0NONE | false | 0ALL | true | The medicines used to treat HIV can suppress but cannot kill all the virus in the body. A small amount of virus remains at low levels in the part of the blood called the plasma. It is of crucial importance to identify the source of the residual virus in patients receiving antiretroviral therapy. The purpose of this stu... | This is a non-randomized, non-comparative, single center trial of antiretroviral therapy intensification using the investigational integrase inhibitor MK-0518 and an investigational viral load assay to measure response to additional antiviral therapy. Eighteen patients will receive open-label MK-0518 400 mg P.O. every ... | HIV Infection | Intensification HIV viremia Human Immunodeficiency Virus | null | 1 | arm 1: Patients will be administered raltegravir 400 mg orally twice daily in addition to antiretroviral therapy | [
0
] | 1 | [
0
] | intervention 1: Antiretroviral drug intensification with Raltegravir (MK0518) 400mg orally every 12 hours for 28 days in addition to the prescribed antiretroviral therapy | intervention 1: Raltegravir (MK-0518) | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00618371 |
[
2
] | 13 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary goals of this study will be to implement innovative processing and detection assays to qualify induced sputum measurements of markers of allergen-induced airway inflammation. The results of this study are intended to form a platform to be used in the clinical development of novel asthma therapeutics. | null | Asthma | null | 2 | arm 1: study medication + Pbo arm 2: Pbo + study medication | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the m... | intervention 1: Comparator: fluticasone intervention 2: Placebo | 0 | null | 0 | NCT00623714 | |
[
2,
3
] | 10 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose of this study is to test whether injected medications will increase the amount of fat released by a fat cell. We will compare prednisolone (a synthetic cortisone) combined with isoproterenol (a drug given for asthma) versus using isoproterenol alone. We will also test if injections of isoproterenol and pred... | Lipomas are benign, non-cancerous fatty tumors that occur under the skin and make a bump that can be easily felt and often seen. The current treatment for lipomas is surgery. Isoproterenol, a medication used for the treatment of asthma and approved for injection under the skin, is known to cause fat cells to give up th... | Lipoma | Obesity therapy fat drug mechanism adipose tissue cellular pharmacology | null | 1 | arm 1: Beta-adrenergic agonists and corticosteroid | [
5
] | 1 | [
0
] | intervention 1: Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks. | intervention 1: Prednisolone synthetic cortisone and Isoproterenol together | 1 | Baton Rouge | Louisiana | United States | -91.18747 | 30.44332 | 0 | NCT00624416 |
[
4
] | 305 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn. | This 4 week study of Dexlansoprazole (TAK-390MR) will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn. | Gastroesophageal Reflux | Non-Erosive Gastroesophageal Reflux Disease GERD heartburn sleep disturbance nocturnal Reflux | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 30 mg capsule, orally, once daily for 4 weeks intervention 2: 1 capsule, orally, once daily for 4 weeks | intervention 1: Dexlansoprazole intervention 2: Placebo | 43 | Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United States | -117.9145 | 33.83529
Garden Grove | California | United States | -117.94145 | 33.77391
Lancaster | California | United States | -118.13674 | 34.69804
Oakland | California | United States | -122.2708 | 37.80437
San Diego | Ca... | 0 | NCT00627016 |
[
2
] | 20 | RANDOMIZED | PARALLEL | null | 0NONE | false | 0ALL | false | The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C. | null | Hepatitis C | Chronic Hepatitis C Protease Inhibitor Telaprevir | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks intervention 2: MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks | intervention 1: MP-424(H), PEG-IFN-a-2b, RBV intervention 2: MP-424 (L), PEG-IFN-a-2b, RBV | 1 | Kawasaki | Takatsu-ku | Japan | 139.71722 | 35.52056 | 0 | NCT00630058 |
[
3
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Prior clinical trials involving bevacizumab and sorafenib have demonstrated single agent activity in previously treated advanced breast cancer. This trial will test combined VEGF inhibition with sorafenib and bevacizumab in less heavily pre-treated patients with advanced breast cancer. | OUTLINE: This is a multi-center study.
Sorafenib 200mg po daily Bevacizumab 5mg/kg every other week
1 Cycle = 4 weeks Imaging every third cycle
Acceptable toxicity and non-PD = Protocol therapy will continue Un-acceptable toxicity or PD = Protocol therapy will be discontinued
ECOG Performance Status 0-1
Life Expec... | Metastatic Breast Cancer | null | 1 | arm 1: Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle | [
0
] | 3 | [
0,
0,
10
] | intervention 1: Sorafenib 200mg po daily intervention 2: Bevacizumab 5mg/kg every other week
1 Cycle = 4 weeks intervention 3: Imaging every third cycle | intervention 1: Sorafenib intervention 2: Bevacizumab intervention 3: Imaging | 10 | Galesburg | Illinois | United States | -90.37124 | 40.94782
Evansville | Indiana | United States | -87.55585 | 37.97476
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Lafayette | India... | 0 | NCT00632541 | |
[
3
] | 34 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with Tarceva treatment, in participants with non-small cell lung cancer. The first cohort of participants enrolled in the study will be treated twice daily with metron... | null | Non-Squamous Non-Small Cell Lung Cancer | null | 2 | arm 1: Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated at the same day as the start of erlotinib. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest will be treated ac... | [
0,
0
] | 3 | [
0,
0,
10
] | intervention 1: Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks. intervention 2: Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks. intervention 3: Left side of the face and chest will be treated according to local standard procedures (... | intervention 1: Erlotinib intervention 2: Metronidazole Actavis intervention 3: Non-active Moisturizing Cream | 6 | Gothenburg | N/A | Sweden | 11.96679 | 57.70716
Lund | N/A | Sweden | 13.19321 | 55.70584
Malmo | N/A | Sweden | 13.00073 | 55.60587
Stockholm | N/A | Sweden | 18.06871 | 59.32938
Umeå | N/A | Sweden | 20.25972 | 63.82842
Vaxjo | N/A | Sweden | 14.80906 | 56.87767 | 0 | NCT00642473 | |
[
3
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treat... | null | Colorectal Cancer | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle intervention 2: 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle intervention 3: 5 mg/kg taken intravenously on Day 1 of each 2 week cycle intervention 4: 85 mg/m2 taken intravenously on Day 1 of each 2 week cycle... | intervention 1: capecitabine [Xeloda] intervention 2: capecitabine [Xeloda] intervention 3: bevacizumab [Avastin] intervention 4: oxaliplatin intervention 5: irinotecan | 76 | PARK Springs | Arizona | United States | N/A | N/A
Sedona | Arizona | United States | -111.76099 | 34.86974
Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United States | -117.9145 | 33.83529
Colton | California | United States | -117.31365 | 34.0739
Greenbrae | California | United Stat... | 0 | NCT00642603 | |
[
4
] | 400 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery | null | Ocular Inflammation | null | 2 | arm 1: Loteprednol etabonate 0.5% ophthalmic ointment arm 2: Vehicle of loteprednol etabonate ointment | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 1/2 inch ribbon four times a day for 14 days intervention 2: 1/2 inch ribbon four times a day for 14 days | intervention 1: 0.5% Loteprednol Etabonate Ophthalmic Ointment intervention 2: Vehicle of Loteprednol Etabonate Ophthalmic Ointment | 1 | Overland Park | Kansas | United States | -94.67079 | 38.98223 | 0 | NCT00645671 | |
[
5
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | To evaluate the effects of Memantine on non-motor symptoms in patients with Parkinson's disease.
Parkinson's disease (PD) affects about one million people in the United States. It is a common neurological condition that is clinically defined by rigidity (muscle stiffness), bradykinesia (slowness of movement) and tremo... | Patients were enrolled over 11 months from the Parkinson Disease Center and Movement Disorder Clinic at Baylor College of Medicine. PD was diagnosed using standard criteria. Specific inclusion criteria were intentionally broad and included both fluctuating and non-fluctuating patients with a UPDRS "motivation" (#4) sco... | Parkinson's Disease | Parkinson's disease non-motor symptoms | null | 2 | arm 1: memantine 10 mg bid arm 2: 2 tabs bid | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 10 mg bid intervention 2: 2 tabs bid | intervention 1: Memantine intervention 2: placebo | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00646204 |
[
3
] | 15 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: There is emerging data to suggest that the optimal use of angiogenesis inhibitors may be in combination with chemotherapy. The optimal use of atrasentan may be in combination with chemotherapy in women with relapsed and refractory ovarian cancer,fallopian tube cancer, and peritoneal serous papillary adenocar... | OBJECTIVES:
Primary
* To determine the median time to tumor progression in patients with recurrent ovarian epithelial cancer, fallopian tube adenocarcinoma, or peritoneal serous papillary adenocarcinoma treated with Doxil and atrasentan hydrochloride.
Secondary
* To determine the objective response rate and surviva... | Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer | recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: Atrasentan 10 mg orally everyday continuously beginning on Day 1. intervention 2: 50 mg/m2 intravenously every 28 days | intervention 1: atrasentan hydrochloride intervention 2: doxil | 6 | Macon | Georgia | United States | -83.6324 | 32.84069
Louisville | Kentucky | United States | -85.75941 | 38.25424
Germantown | Tennessee | United States | -89.81009 | 35.08676
Jackson | Tennessee | United States | -88.81395 | 35.61452
Nashville | Tennessee | United States | -86.78444 | 36.16589
Nashville | Tennessee |... | 0 | NCT00653328 |
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