sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 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 completing 1 year of treatment, pts deriving clinical benefit may continue to receive sunitinib in a separate continuation protocol).

intervention 1: carboplatin intervention 2: paclitaxel intervention 3: sunitinib

31

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 response to Gleevec or the combined treatment may promote a better response than using Gleevec alone.

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 cytogenetic response after 4 cycles or less will be discontinued. Otherwise, patients may continue additional cycles of this combined treatment for a maximum of 12 cycles.

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 Leukemia, Myeloid, Chronic Phase Leukemia, Myeloid, Accelerated-Phase Myeloid, Leukemia, Chronic, Chronic Phase Leukemia, Myeloid, Accelerated Phase Homoharringtonine Omacetaxine

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 600 mg for participants in the accelerated or blast phase of CML.

[ 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 from the study. Otherwise, participants may continue additional cycles of this combined treatment for a maximum of 12 cycles. Participants who achieved a molecular or cytogenetic response, or a complete hematologic remission (CHR), could undergo subsequent cycles with a maintenance schedule of homoharringtonine 2.5 mg/m\^2 by continuous 24-hour IV infusion daily for 2 days every 4 weeks. Dose escalations in subsequent cycles were allowed by one day at a time if the participant was unable to maintain CHR in the maintenance schedule. intervention 2: Taken by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML. For the first cycle of therapy only, imatinib was started on Day 4 of homoharringtonine treatment.

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 BAY43-9006, and for how long these patients live without progression * Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a * Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage * Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer * Find out the level of BAY43-9006 in the blood once per month and any changes in this level * Find out whether BAY43-9006 effects are associated with specific biomarkers

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 \[median\]) on a continuous basis. arm 2: Interferon (IFN) α-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period.After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 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 | United States | -81.69541 | 41.4995 Portland | Oregon | United States | -122.67621 | 45.52345 Dallas | Texas | United States | -96.80667 | 32.78306 Seattle | Washington | United States | -122.33207 | 47.60621 Bordeaux | N/A | France | -0.5805 | 44.84044 Lille | N/A | France | 3.05858 | 50.63297 Lyon | N/A | France | 4.84671 | 45.74846 Marseille | N/A | France | 5.38107 | 43.29695 Nantes | N/A | France | -1.55336 | 47.21725 Paris | N/A | France | 2.3488 | 48.85341 Toulouse | N/A | France | 1.44367 | 43.60426 Villejuif | N/A | France | 2.35992 | 48.7939 Ulm | Baden-Wurttemberg | Germany | 9.99155 | 48.39841 München | Bavaria | Germany | 13.46314 | 48.69668 Hamburg | City state of Hamburg | Germany | 9.99302 | 53.55073 Frankfurt am Main | Hesse | Germany | 8.68417 | 50.11552 Düsseldorf | North Rhine-Westphalia | Germany | 6.77616 | 51.22172 Mainz | Rhineland-Palatinate | Germany | 8.2791 | 49.98419 Berlin | State of Berlin | Germany | 13.41053 | 52.52437 Gdansk | N/A | Poland | 18.64912 | 54.35227 Krakow | N/A | Poland | 19.93658 | 50.06143 Poznan | N/A | Poland | 16.92993 | 52.40692 Szczecin | N/A | Poland | 14.55302 | 53.42894 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Kazan' | N/A | Russia | 49.12214 | 55.78874 Kirov | N/A | Russia | 49.66007 | 58.59665 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Donetsk | N/A | Ukraine | 37.80224 | 48.023 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Lviv | N/A | Ukraine | 24.02324 | 49.83826 London | London | United Kingdom | -0.12574 | 51.50853 Sutton | Surrey | United Kingdom | -0.2 | 51.35

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 killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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 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 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA. After completion of study treatment, patients are followed within 4 weeks.

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 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.

[ 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 in people with schizophrenia. This is a 3-week study aimed to investigate the feasibility of this treatment approach. Participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. Participants in the control behavioral treatment group receive gift cards regardless of cotinine level. Any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. If we have favorable results from this trial, we will expand it into a smoking treatment program.

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 de novo liver transplant recipients. The treatment is compared to the same treatment regimen including intraoperative steroids with respect to rejection episodes.

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 injection within 8 hours after reperfusion of the graft. arm 2: No 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 and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.

[ 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 intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels. intervention 3: Intravenous prednisolone (loading dose: 300 mg/m2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m²/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m²/day orally (until end of month 2), to 2.5 mg/m²/day orally (until end of month 3) and to 1 mg/m²/day orally (until end of month 6).

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 (Phase II component) of bexarotene oral capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.

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 individual patient. The recommended Phase II dose is defined as the highest dose of bexarotene oral capsules (300 mg/m2 or 400 mg/m2) in combination with carboplatin and Taxol® that induces DLT in fewer than or equal to 33% of patients. The sequential phase II portion of the study will evaluate the efficacy of bexarotene oral capsules in combination with carboplatin and weekly Taxol® in patients with advanced non-small cell lung cancer. The efficacy will be gauged according to the rate of major response where, by definition, a major response occurs if a patient achieves either complete remission (CR) or partial remission (PR). For these patients a true response rate of 20% or greater is sufficiently large to warrant further investigation. A true response rate of 10% or less indicates that the combination is less active.

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 improvement of their PASI and PGA scores.

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 response to chemotherapy, and to improve the duration of survival of patients with metastatic breast cancer. The anticancer mechanism of action of trastuzumab is unknown, but it is possible that trastuzumab acts by promoting antibody-dependent cell mediated cytotoxicity (ADCC), or direct killing of cancer cells by immune cells, triggered by antibodies bound to the surface of the cancer cell. G-CSF is a drug which is a growth factor for certain types of immune cells. G-CSF has two favorable effects on ADCC. G-CSF increases the pool of circulating cancer-killing immune cells, and G-CSF increases the strength of binding of cancer-killing immune cells to a specific part of the antibody. Therefore, priming with G-CSF significantly increases the efficiency of ADCC, and four days of treatment with G-CSF has been shown to optimize ADCC in some studies. Recent data from the investigators' laboratory indicates that chemotherapy can augment ADCC directed against tumor cells. The investigators' hypothesis is that pre-treatment with the drug G-CSF would increase the effectiveness of chemotherapy given with trastuzumab.

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 days weekly for two weeks. Subsequently, all patients will receive an additional 12 weeks of weekly trastuzumab, G-CSF by SQ injection daily for five days weekly for 12 weeks, and vinorelbine once weekly at a dose of 25 mg/m2 weeks 3, 4, 6, 7, 9, 10, 12, 13. Baseline evaluation will include a history and physical exam, comprehensive metabolic panel (CMP), complete blood count (CBC), serum pregnancy test, computerized tomography (CT) scan for disease measurements, and a Multiple Uptake Gated Acquisition (MUGA) scan. The CT scan and MUGA will be repeated upon completion of the study treatment. Blood will be drawn pre-trastuzumab, 2 hours post-trastuzumab, and 48 hours post-trastuzumab on weeks 1, 2, 3, 4, and 12 to measure whole blood ADCC activity. Two additional assays for whole blood ADCC activity will be drawn at baseline pre-treatment, and following completion of protocol treatment. These assays will measure chromium release from a Her-2 positive target cell exposed to the patient's effector cells. Measurement of soluble Her-2 in patient serum will also be measured at each ADCC time point.

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 mg/kg IV weeks 3 through 14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13 and G-CSF at 5 mcgm/kg SQ daily Monday through Friday weeks 3-14. arm 2: Subjects will receive ten doses of a placebo injection SQ 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 mg/kg weeks 3-14, vinorelbine at 25 mg/m2 IV weekly weeks 3,4,6,7,9,10,12,13, and G-CSF at 5 mcgm/kg SQ daily Monday through Fridays weeks 3-14.

[ 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 through Friday of the first two weeks of the study intervention 5: Saline will be given SQ daily for ten days, Monday through Friday of the first two weeks of the study

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 transplantation. Those patients receiving donor marrow will have the T cells (a type of white blood cell in the donor marrow) removed to lower the risk that the new marrow will react to their body, a condition called Graft-Versus-Host-Disease (GVHD). After bone marrow transplantation, subjects will receive drugs to help prevent GVHD, including cyclosporin and mycophenolate mofetil (MMF). Blood samples are taken at day 28, day 60, day 100, 1 year and as required by medical status yearly for five years after transplant to evaluate how well the new marrow is growing. A bone marrow biopsy is required at day 21, at day 100 and 1 year.

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 therapy to specific areas of the body intervention 4: Busulfan 8 mg/kg (total) on Days - 8 and -7 (orally or through the catheter), intervention 5: anti-thymocyte globulin (ATG) 15 mg/kg on days -2 and -1 via catheter

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 (CDMS) and the development of neurological disability over a 10 year period of observation. The initial 5 year extension study, called CHAMPIONS5, reported that immediate initiation of interferon Beta-1a (AVONEX) after a first attack of MS continued to delay the development of CDMS and lowered relapse rates compared to delayed initiation of disease modifying treatment (usually with AVONEX) either at the time of a second attack or at the end of the phase III study (24 months). The study was extended to 10 years to determine if these effects are sustained and result in less long term permanent disability.

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 clinical definite Multiple Sclerosis (CDMS)(as defined by a second, clinically verifiable attack involving another part of the central nervous system) over 2 years of observation and significantly decreased the development of new or enlarging white matter lesions on MRI over 18 months (see reference). The current study is a long term extension of a cohort of CHAMPS study site and participants. The three main aims of the study are as follows: 1. To determine the long term neurological outcome in patients treated with interferon beta 1a (AVONEX) from onset of a first clinical demyelinating event 2. To determine if immediate initiation of AVONEX therapy (the CHAMPS Avonex treatment group) confers long term benefits compared to delayed initiation of therapy (the CHAMPS placebo group) on the rate of development of CDMS, annualized relapse rates, the development of permanent disability and MR measures of disease activity and progression. 3. To determine predictors of long term disease activity and disability in patients following a first clinical demyelinating event

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 observation

[ 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, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

intervention 1: interferon beta 1a 30 ug IM once weekly

26

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 is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

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 assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.

[ 0 ]

3

[ 0, 0, 0 ]

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 participants will receive daily escitalopram for 8 weeks. Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks. Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment, based on the their preference. Study visits are made at baseline, and at Weeks 1, 2, 4, and 8 in Phase 1 and Weeks 12 and 16 in Phase 2.

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 least minimal improvement (CGI-I \< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). arm 3: Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I \< 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).

[ 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-specific antigen PSA, reduction in symptoms (particularly pain), or stabilization of disease. Clear reductions in tumor bulk or PSA may provide objective evidence of a treatment effect, and stabilization of disease may be just as clinically meaningful in patients who are actively progressing prior to starting therapy. Pemetrexed has shown a broad array of activity in many diseases that until now were thought to be non-responsive to chemotherapy in the second-line setting. This trial is designed to further assess the efficacy, safety, tolerability, and pharmacogenetics of pemetrexed as a single agent in subjects with HRPC whose disease has progressed following one prior taxane-based chemotherapy regimen for HRPC.

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 preceding the first dose of pemetrexed, and dosing should continue during the full course of therapy and for 21 days after the last dose of pemetrexed. * Vitamin B12 (1000 µg) will be administered as an intramuscular injection during the week preceding the first dose of pemetrexed and every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed. Performance Status: Karnofsky Performance Status 70-100 Life expectancy \> 12 weeks Hematopoietic: * Absolute Neutrophil Count (ANC) \> 1500/mm3 * Platelet count \> 100,000/mm3 * Hemoglobin \> 9 g/dL Hepatic: * Bilirubin \< 1.5 X upper limit of normal (unless due to Gilbert's disease) * Alkaline phosphatase and Alanine Transanimase (ALT) (SGPT) \< 3 X upper limit of normal (ULN); may be \< 5 X ULN for patients with liver metastases. Alkaline phosphatase may be any value for patients with bone metastases. Renal: * Calculated creatinine clearance \>45 mL/min based on the standard Cockroft and Gault formula Cardiovascular: * No congestive heart failure requiring therapy or New York Heart Association (NYHA) class II or greater or active angina or known myocardial infarction within 12 months prior to study * No unstable angina, uncontrolled congestive heart failure, or unstable symptomatic arrhythmia requiring medication within 6 months prior to being registered for protocol therapy * Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, or controlled hypertension are eligible Pulmonary: * Not specified

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 thereafter on the same day of pemetrexed administration

[ 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 patients received vitamin B12 1000ug intramuscular injection the week preceding the first pemetrexed dose and received additional 1000ug intramuscular injections every three cycles thereafter on the same day of pemetrexed administration.

intervention 1: Pemetrexed intervention 2: Folic Acid intervention 3: Vitamin B12

15

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 therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.

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. * Correlate the amount of radiation delivered to a tumor with low-dose \^153Sm-EDTMP with that of high-dose \^153Sm-EDTMP in patients treated with this regimen. Secondary * Determine the overall and progression-free survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. * Determine the long-term effects of this regimen in these patients. * Determine the predictive value of fludeoxyglucose F 18 positron emission tomography (FDG-PET), diffusion-weighted MRI, and magnetic resonance spectroscopy for evaluation of treatment response in patients treated with this regimen. OUTLINE: Patients are stratified according to resectability of the primary tumor (recurrent, refractory, or very high-risk disease vs unresectable primary tumor). * Mobilization and collection of autologous peripheral blood stem cells (PBSCs)\* : Patients receive ifosfamide IV daily for 5 days followed by filgrastim (G-CSF) subcutaneously daily. Patients then undergo leukapheresis for collection of autologous PBSCs until ≥ 2 x 10\^6 CD34 (cluster of differentiation 34)-positive cells/kg are collected. NOTE: \*Patients who have undergone PBSC collection before study entry proceed to high-dose samarium Sm 153 lexidronam pentasodium (153Sm-EDTMP) infusion without mobilization and collection of autologous PBSCs. * 153Sm-EDTMP infusion: Patients receive a trace dose of \^153Sm-EDTMP\*\* IV over 1-2 minutes and undergo bone scan 4, 24, and 48-72 hours later. Six weeks later, patients receive high-dose \^153Sm-EDTMP IV over 1-2 minutes and undergo repeat bone scans 4, 24, and 48-72 hours later. NOTE: \*\*Patients may receive the trace dose on protocol JHOC (Johns Hopkins Oncology Center)-J0094. * Autologous peripheral blood stem cell transplantation (PBSCT): Between 12-14 days after administration of high-dose \^153Sm-EDTMP, patients undergo autologous PBSCT. Beginning 2 days later, patients receive G-CSF IV daily. * External-beam radiotherapy: Patients then undergo external-beam radiotherapy to the sites of bulky disease. * Surgery: Some patients may also undergo surgical resection of residual disease. After completion of study treatment, patients are followed periodically for up to 3 years. PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

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) administered after autologous stem cell collection intervention 5: Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation.

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 training and placebo medication. One hundred and eighty participants will be recruited and, subsequent to a platform of outpatient treatment for alcoholism, will be randomly 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 or placebo. The treatments will conclude with a 2-week medication/placebo taper. Follow-up assessments will be conducted at post-treatment and at 3, 6, 9, and 12-months. The long-term objectives of this research are to develop a real-world combination of psychosocial and pharmacological treatments for patients with comorbid alcohol-use and anxiety disorders that compromise prognosis, and to evaluate the effectiveness of combined psychosocial and pharmacological treatments that target anxiety among patients with this comorbidity.

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, well-controlled treatment outcome trials, the optimal treatment (or combination of treatments) remains unknown. Real world practice in the treatment of alcohol-use disorders frequently begins with brief detoxification and stabilization, and is often followed by some combination of CBT and pharmacotherapy for patients complaining of mood difficulties while attempting early abstinence from alcohol. The purpose of the present study is to evaluate the relative benefits of psychosocial and psychopharmacological therapy for the treatment of co-morbid anxiety and alcohol dependence among patients attempting early abstinence from alcohol. We will address the following four questions: 1. During the course of intervention, is treatment of anxiety disorders with combined treatments of established utility (among non-alcohol-use-disordered patients) superior in managing both return to drinking and anxiety symptoms than either monotherapy, or a fully inactive control treatment? 2. During the follow-up period, will patients who received the combined active treatments fare better in maintaining abstinence relative to the single active treatments, and those in the control condition? 3. What psychosocial variables (such as increases or lapses to elevated anxiety) mediate return to pre-treatment levels of alcohol use? 4. Will baseline indices of alcohol dependence and anxiety disorder severity moderate the relationship between treatment and outcome during both the acute and follow-up phases of the study?

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 medication taper. arm 2: CBT is Cognitive Behavioral Treatment which will be tailored to participants.For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo. arm 3: Progressive Muscle Relaxation Therapy (PMR) is a technique of alternately tensing and relaxing muscles groups in sequence throughout the body. . 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. The treatments will conclude with a 2-week medication/placebo taper. arm 4: Progressive Muscle Relaxation Therapy (PMR) is a technique of alternately tensing and relaxing muscles groups in sequence throughout the body. . For patients with co-morbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.

[ 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. 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. The treatments will conclude with a 2-week medication/placebo taper. intervention 3: For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo. intervention 4: For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.

intervention 1: Venlafaxine intervention 2: CBT intervention 3: Progressive muscle relaxation therapy (PMR) intervention 4: Placebo medication

2

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 during lunch. arm 2: 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day). The placebo consists of 6 tablets/day. 2 tablets taken orally with half a glass of water during 3 main meals. 1 tablet/day of acetylsalicylic acid during lunch.

[ 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 | 44.43225 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Yekaterinburg | N/A | Russia | 60.6122 | 56.8519

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 adults treated with placebo will be relatively low (minority of patients).

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 referring to an accumulation of fluid within the middle ear space, in absence of signs indicating acute infection. Commonly, this can result in a conductive hearing loss due to restriction of tympanic membrane mobility. Negative Middle Ear Pressure (NMEP) is often a precursor to the development of SOM, and has it's own effect on the acoustic properties of the middle ear, also resulting in conductive hearing loss. Due to the lack of a single accepted medical intervention to deal with ETD and the general benign nature of this condition, it is common practice for some physicians to take a "wait and see" initial approach when this clinical entity is encountered in lieu of prescribing unproved medications. It is generally accepted that some patients with Negative Middle Ear Pressure (NMEP) and/or Serous Otitis Media (SOM) will undergo spontaneous resolution of symptoms, yet the exact resolution rates are not clearly defined. The purpose of this double-blind, randomized study of either triamcinolone acetonide nasal spray or a sham placebo nasal spray for 6 weeks is to determine if there is improvement in a test of middle ear pressure. Neither the subjects nor the Investigator will know which of the two treatments is being used until the end of the study. Resolution of ETD symptoms will be measured by changes in the tympanogram, a test to measure pressure within the middle ear. This measurement will be taken at baseline and after 6 weeks of treatment.

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/spray) (total daily dose 110 micrograms) for 6 weeks duration. arm 2: Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration. Subjects younger than 12 years old received received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration.

[ 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). intervention 2: Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily. Subjects younger than 12 years old received received 1 metered spray of placebo solution in each nostril once daily.

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 overexpression and/or EGFR amplification.

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

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 daily for 48 weeks

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 | California | United States | -117.86783 | 33.74557 West Hills | California | United States | -118.64398 | 34.19731 Hollywood | Florida | United States | -80.14949 | 26.0112 Jacksonville | Florida | United States | -81.65565 | 30.33218 West Palm Beach | Florida | United States | -80.05337 | 26.71534 Augusta | Georgia | United States | -81.97484 | 33.47097 Topeka | Kansas | United States | -95.67804 | 39.04833 Springfield | Massachusetts | United States | -72.58981 | 42.10148 Detroit | Michigan | United States | -83.04575 | 42.33143 Columbia | Missouri | United States | -92.33407 | 38.95171 St Louis | Missouri | United States | -90.19789 | 38.62727 Orchard Park | New York | United States | -78.74392 | 42.76756 Stony Brook | New York | United States | -73.14094 | 40.92565 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Kettering | Ohio | United States | -84.16883 | 39.6895 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Columbia | South Carolina | United States | -81.03481 | 34.00071 Dallas | Texas | United States | -96.80667 | 32.78306 Houston | Texas | United States | -95.36327 | 29.76328 Lubbock | Texas | United States | -101.85517 | 33.57786 San Antonio | Texas | United States | -98.49363 | 29.42412 Ogden | Utah | United States | -111.97383 | 41.223 Milwaukee | Wisconsin | United States | -87.90647 | 43.0389 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 La Plata | N/A | Argentina | -57.95442 | -34.92126 Morón | N/A | Argentina | -58.62205 | -34.65118 Quilmes | N/A | Argentina | -58.25454 | -34.72065 Curitiba | N/A | Brazil | -49.27306 | -25.42778 Fortaleza | N/A | Brazil | -38.54306 | -3.71722 Goiânia | N/A | Brazil | -49.25389 | -16.67861 Recife | N/A | Brazil | -34.88111 | -8.05389 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Burgas | N/A | Bulgaria | 27.46781 | 42.50606 Gabrovo | N/A | Bulgaria | 25.33417 | 42.87472 Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Veliko Tarnovo | N/A | Bulgaria | 25.62904 | 43.08124 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Courtice | Ontario | Canada | -78.76626 | 43.91682 North York | Ontario | Canada | N/A | N/A Oshawa | Ontario | Canada | -78.84957 | 43.90012 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Richmond Hill | Ontario | Canada | -79.43725 | 43.87111 Scarborough Village | Ontario | Canada | -79.22124 | 43.73899 Thunder Bay | Ontario | Canada | -89.25018 | 48.38202 Greenfield Park | Quebec | Canada | -73.46223 | 45.48649 Montreal | Quebec | Canada | -73.58781 | 45.50884 Aalborg | N/A | Denmark | 9.9187 | 57.048 Blegdamsvej 9 | N/A | Denmark | N/A | N/A Farsø | N/A | Denmark | 9.33925 | 56.77276 Gentofte Municipality | N/A | Denmark | 12.54601 | 55.74903 Hillerød | N/A | Denmark | 12.30081 | 55.92791 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Køge | N/A | Denmark | 12.18214 | 55.45802 Annonay | N/A | France | 4.6707 | 45.23992 Besançon | N/A | France | 6.01815 | 47.24878 Bondy | N/A | France | 2.48931 | 48.9018 Colmar | N/A | France | 7.35584 | 48.08078 Corbeil-Essonnes | N/A | France | 2.48757 | 48.60603 Corsept | N/A | France | -2.06062 | 47.27678 Creil | N/A | France | 2.48477 | 49.25672 Grenoble | N/A | France | 5.71479 | 45.17869 La Chapelle-sur-Erdre | N/A | France | -1.55239 | 47.29964 Nantes | N/A | France | -1.55336 | 47.21725 Paris | N/A | France | 2.3488 | 48.85341 Pessac | N/A | France | -0.6324 | 44.80565 Quimper | N/A | France | -4.09795 | 47.99597 Baja | N/A | Hungary | 18.95307 | 46.18299 Balatonfüred | N/A | Hungary | 17.87187 | 46.96188 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Győr | N/A | Hungary | 17.63512 | 47.68333 Gyula | N/A | Hungary | 21.28333 | 46.65 Hodmeztvasarhely | N/A | Hungary | N/A | N/A Kecskemét | N/A | Hungary | 19.69128 | 46.90618 Keszthely | N/A | Hungary | 17.24317 | 46.76812 Miskolc | N/A | Hungary | 20.77806 | 48.10306 Mosonmagyaróvár | N/A | Hungary | 17.26994 | 47.86789 Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539 Székesfehérvár | N/A | Hungary | 18.41034 | 47.18995 Szolnok | N/A | Hungary | 20.2 | 47.18333 Tatabánya | N/A | Hungary | 18.39325 | 47.58494 Zalaegerszeg | N/A | Hungary | 16.84389 | 46.84 Acireale | CT | Italy | 15.16577 | 37.60886 Florence | FI | Italy | 11.24626 | 43.77925 Roma | RM | Italy | 11.10642 | 44.99364 Sottomarnia Di Chioggia | VE | Italy | N/A | N/A Bergamo | N/A | Italy | 9.66721 | 45.69601 Cagliari | N/A | Italy | 9.11917 | 39.23054 Milan | N/A | Italy | 12.59836 | 42.78235 San Giovanni Rotondo | N/A | Italy | 15.7277 | 41.70643 Sassari | N/A | Italy | 8.55552 | 40.72586 Treviglio | N/A | Italy | 9.59102 | 45.52081 Aguascalientes | N/A | Mexico | -102.2843 | 21.88262 Cauntla | N/A | Mexico | N/A | N/A Distrito Federal | N/A | Mexico | -93.02694 | 16.59 Durango | N/A | Mexico | -104.65756 | 24.02032 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Saltillo | N/A | Mexico | -100.97963 | 25.42595 San Luis Potosí City | N/A | Mexico | -100.97135 | 22.15234 Zapopan | N/A | Mexico | -103.38742 | 20.72111 Baia Mare | N/A | Romania | 23.56808 | 47.65729 Brasov | N/A | Romania | 25.60613 | 45.64861 Bucharest | N/A | Romania | 26.10626 | 44.43225 Craiova | N/A | Romania | 23.8 | 44.31667 Lasi | N/A | Romania | N/A | N/A Târgu Mureş | N/A | Romania | 24.55747 | 46.54245 Timișoara | N/A | Romania | 21.22571 | 45.75372

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, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with cyclophosphamide and cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works when given together with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced pancreatic cancer.

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 specific in vivo parameters of immune response (e.g., mesothelin, prostate stem cell antigen \[PSCA\], mutated k-ras-specific T-cell responses) with clinical response in patients treated with this regimen. * Correlate downstream targets of epidermal growth factor receptor (EGFR) signaling (e.g., intratumor expression of Akt, Stat 3 and 5, mesothelin, mutated k-ras, and PSCA) with inhibition by cetuximab in patients treated with this regimen. * Correlate inhibition of EGFR signaling (e.g., Stat 3 and 5) with improved specific mesothelin, PSCA, and mutated k-ras-specific T-cell responses in patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive cyclophosphamide IV on day 0, sargramostim plasmid DNA pancreatic tumor vaccine intradermally on day 1, and cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection and tumor biopsies periodically during study for biomarker correlative studies. At the completion of study treatment, patients are followed at 3 weeks and then every 4 weeks for 16 weeks. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

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 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles.

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 investigating the effects of smoked cannabis in subjects prescribed morphine or oxycodone for chronic pain. We will also assess the clinical safety of cannabinoids and these opioids by monitoring the short-term side effects associated with combined therapy.

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, however, is the potential for greater than additive analgesic effect of cannabinoids and opioids in combination that would allow for opioid analgesic effect to be achieved at lower dosages than are necessary alone, which could overcome problems with both tolerance and side effects for both drug classes. Unfortunately, safety data on the combination in humans does not exist at this time and needs to be obtained. As increasing numbers of patients with chronic pain may turn to cannabis to augment the effects of their opioid analgesics, data on potential pharmacokinetic interactions and clinical safety of the combinations should be evaluated in a controlled clinical research setting.

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 | N/A Asahi, Chiba | N/A | Japan | N/A | N/A Asahikawa, Hokkaido | N/A | Japan | 142.36489 | 43.77063 Asahikawa, Hokkaido | N/A | Japan | 142.36489 | 43.77063 Atsugi, Kanagawa | N/A | Japan | N/A | N/A Bunkyo-ku, Tokyo | N/A | Japan | N/A | N/A Chitose, Hokkaido | N/A | Japan | 141.65222 | 42.81944 Chuo-ku, Chiba, Chiba | N/A | Japan | N/A | N/A Chuo-ku, Kobe, Hyogo | N/A | Japan | N/A | N/A Chuo-ku, Sapporo, Hokkaido | N/A | Japan | N/A | N/A Chuo-Ku, Sappro, Hokkaido | N/A | Japan | 130.67068 | 33.63867 Chuo-ku, Sappro, Hokkaido | N/A | Japan | 130.67068 | 33.63867 Daito, Osaka | N/A | Japan | N/A | N/A Fuchu, Tokyo | N/A | Japan | N/A | N/A Fujieda, Shizuoka | N/A | Japan | N/A | N/A Fukaya, Saitama | N/A | Japan | N/A | N/A Fukui, Fukui | N/A | Japan | N/A | N/A Fukuroi, Shizuoka | N/A | Japan | N/A | N/A Funabashi, Chiba | N/A | Japan | N/A | N/A Fushimi-ku, Kyoto, Kyoto | N/A | Japan | N/A | N/A Gifu, Gifu | N/A | Japan | N/A | N/A Habikino, Osaka | N/A | Japan | N/A | N/A Hachioji, Tokyo | N/A | Japan | N/A | N/A Hakodate, Hokkaido | N/A | Japan | 140.73667 | 41.77583 Hakodate, Hokkaido | N/A | Japan | 140.73667 | 41.77583 Hamada, Shimane | N/A | Japan | N/A | N/A Hashima-gun, Gifu | N/A | Japan | 136.76039 | 35.42291 Hidaka, Saitama | N/A | Japan | N/A | N/A Higashi-ku, Sappro, Hokkaido | N/A | Japan | 130.56341 | 32.40781 Higashi-osaka, Osaka | N/A | Japan | N/A | N/A Higashidakawa-gun, Yamagata | N/A | Japan | 140.36667 | 38.23333 Higashimatsushima, Miyagi | N/A | Japan | N/A | N/A Higashinari-ku, Osaka, Osaka | N/A | Japan | N/A | N/A Higashiosaka, Osaka | N/A | Japan | N/A | N/A Higashisonogi-gun, Nagasaki | N/A | Japan | 129.88333 | 32.75 Higashiyodogawa-ku, Osaka, Osaka | N/A | Japan | N/A | N/A Himeji, Hyogo | N/A | Japan | N/A | N/A Hitachi, Ibaraki | N/A | Japan | N/A | N/A Hitachinaka, Ibaraki | N/A | Japan | N/A | N/A Ibusuki, Kagoshima | N/A | Japan | N/A | N/A Ichikawa, Chiba | N/A | Japan | N/A | N/A Iida, Nagano | N/A | Japan | N/A | N/A Inashiki-gun, Ibaraki | N/A | Japan | 135.56828 | 34.81641 Isesaki, Gunma | N/A | Japan | 139.2 | 36.31667 Isesaki, Gunma | N/A | Japan | 139.2 | 36.31667 Itami, Hyogo | N/A | Japan | N/A | N/A Iwanuma, Miyagi | N/A | Japan | N/A | N/A Iwata, Shizuoka | N/A | Japan | N/A | N/A Izuka, Fukuoka | N/A | Japan | N/A | N/A Izumisano, Osaka | N/A | Japan | N/A | N/A Izumo, Shimane | N/A | Japan | N/A | N/A Izunokuni, Shizuoka | N/A | Japan | N/A | N/A Kahoku-gun, Ishikawa | N/A | Japan | 127.82139 | 26.42333 Kameda-gun, Hokkaido | N/A | Japan | N/A | N/A Kamigyo-ku, Kyoto, Kyoto | N/A | Japan | N/A | N/A Kasama, Ibaraki | N/A | Japan | N/A | N/A Kasuga, Fukuoka | N/A | Japan | N/A | N/A Kasuga, Fukuoka | N/A | Japan | N/A | N/A Kawachinagano, Osaka | N/A | Japan | N/A | N/A Kisarazu, Chiba | N/A | Japan | N/A | N/A Kishiwada, Osaka | N/A | Japan | N/A | N/A Kita-ku, Nagoya, Aichi | N/A | Japan | N/A | N/A Kita-ku, Osaka, Osaka | N/A | Japan | N/A | N/A Kita-ku, Osaka, Osaka | N/A | Japan | N/A | N/A Kita-ku, Sappro, Hokkaido | N/A | Japan | 139.73348 | 35.75264 Kitami, Hokkaido | N/A | Japan | 143.89083 | 43.80306 Kitami, Hokkaido | N/A | Japan | 143.89083 | 43.80306 Kiyose, Tokyo | N/A | Japan | N/A | N/A Kiyose, Tokyo | N/A | Japan | N/A | N/A Kochi, Kochi | N/A | Japan | N/A | N/A Kochi, Kochi | N/A | Japan | N/A | N/A Koriyama, Fukushima | N/A | Japan | N/A | N/A Koriyama, Fukushima | N/A | Japan | N/A | N/A Koshi, Kumamoto | N/A | Japan | N/A | N/A Kurashiki, Okayama | N/A | Japan | N/A | N/A Kushiro | N/A | Japan | 144.37472 | 42.975 Kushiro | N/A | Japan | 144.37472 | 42.975 Kushiro | N/A | Japan | 144.37472 | 42.975 Marugame, Kagawa | N/A | Japan | N/A | N/A Matsudo, Chiba | N/A | Japan | N/A | N/A Matsumoto, Nagano | N/A | Japan | N/A | N/A Meguro-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895 Meito-ku, Nagoya, Aichi | N/A | Japan | N/A | N/A Midori-ku, Yokohama, Kanagawa | N/A | Japan | N/A | N/A Minami-ku, Hiroshima, Hiroshima | N/A | Japan | N/A | N/A Miyagino-ku, Sendai, Miyagi | N/A | Japan | N/A | N/A Miyazaki, Miyazaki | N/A | Japan | N/A | N/A Moriguchi, Osaka | N/A | Japan | N/A | N/A Morioka, Iwate | N/A | Japan | N/A | N/A Morioka, Iwate | N/A | Japan | N/A | N/A Moriya, Ibaraki | N/A | Japan | N/A | N/A Moriya, Ibaraki | N/A | Japan | N/A | N/A Musashimurayama, Tokyo | N/A | Japan | N/A | N/A Musashino, Tokyo | N/A | Japan | N/A | N/A Naka-ku, Hamamatsu, Shizuoka | N/A | Japan | N/A | N/A Naka-ku, Hamamatsu, Shizuoka | N/A | Japan | N/A | N/A Naka-ku, Nagoya, Aichi | N/A | Japan | N/A | N/A Nakagawa-ku, Nagoya, Aichi | N/A | Japan | N/A | N/A Nakagawa-ku, Nagoya, Nagoya | N/A | Japan | N/A | N/A Namegata, Ibaraki | N/A | Japan | N/A | N/A Nanao, Ishikawa | N/A | Japan | N/A | N/A Nishi-yodogawa-ku, Osaka, Osaka | N/A | Japan | N/A | N/A Nishisonogi-gun, Nagasaki | N/A | Japan | 129.88333 | 32.75 Noda, Chiba | N/A | Japan | N/A | N/A Obu, Aichi | N/A | Japan | N/A | N/A Ohnojo, Fukuoka | N/A | Japan | 130.41667 | 33.6 Okayama, Okayama | N/A | Japan | N/A | N/A Okinawa, Okinawa | N/A | Japan | N/A | N/A Sagamihara, Kanagawa | N/A | Japan | N/A | N/A Sakai, Osaka | N/A | Japan | N/A | N/A Sakai, Osaka | N/A | Japan | N/A | N/A Saku, Nagano | N/A | Japan | N/A | N/A Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Setagaya-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895 Shibuya-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895 Shimogyo-ku, Kyoto, Kyoto | N/A | Japan | N/A | N/A Shimotsuke, Tochigi | N/A | Japan | N/A | N/A Shiroishi, Miyagi | N/A | Japan | N/A | N/A Simizu-ku, Shizuoka, Shizuoka | N/A | Japan | N/A | N/A Suminoe-ku, Osaka, Osaka | N/A | Japan | N/A | N/A Susono, Shizuoka | N/A | Japan | N/A | N/A Suwa, Nagano | N/A | Japan | N/A | N/A Takasaki, Gunma | N/A | Japan | 139.01667 | 36.33333 Takatsuki, Osaka | N/A | Japan | N/A | N/A Takayama, Gifu | N/A | Japan | N/A | N/A Takikawa, Hokkaido | N/A | Japan | 141.90639 | 43.55278 Tatebayashi, Gunma | N/A | Japan | 139.53333 | 36.25 Teine-ku, Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Tenri, Nara | N/A | Japan | N/A | N/A Tonami, Toyama | N/A | Japan | N/A | N/A Toride, Ibaraki | N/A | Japan | N/A | N/A Toyama, Toyama | N/A | Japan | N/A | N/A Toyohashi, Aichi | N/A | Japan | N/A | N/A Toyota, Aichi | N/A | Japan | N/A | N/A Tsuchiura, Ibaraki | N/A | Japan | N/A | N/A Ueda, Nagano | N/A | Japan | N/A | N/A Uji, Kyoto | N/A | Japan | N/A | N/A Ukyo-ku, Kyoto, Kyoto | N/A | Japan | N/A | N/A Urayasu, Chiba | N/A | Japan | N/A | N/A Wakayama, Wakayama | N/A | Japan | N/A | N/A Wko, Saitama | N/A | Japan | 139.65657 | 35.90807 Yaizu, Shizuoka | N/A | Japan | N/A | N/A Yamashina, Kyoto, Kyoto | N/A | Japan | N/A | N/A Yanai, Yamaguchi | N/A | Japan | N/A | N/A Yao, Osaka | N/A | Japan | N/A | 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 grown in the laboratory) showed some anti-tumor response. Objective: To determine whether tumor-fighting cells taken from a melanoma tumor and grown in the lab can more effectively at fight melanoma when the patient's immune system is suppressed and cannot attack them. Eligibility: Patients 18 years of age or older with metastatic melanoma who have tumor reactive cells available. Design: -Patients are assigned to one of two groups - those having received prior therapy with Interleukin-2 (IL-2) and those who have not. After five days of injections of filgrastim, a medicine to stimulated the growth of white blood cells, patients undergo apheresis or bone marrow harvesting, or both, to collect stem cells for later re-infusion. For apheresis, whole blood is collected through a needle in an arm vein and circulated through a cell-separating machine where the stem cells are extracted. The rest of the blood is returned through the same needle or a needle in the other arm. Bone marrow harvesting is done under general anesthesia. Stem cells are collected through a large needle inserted into the hipbone.-Patients' immune system cells and bone marrow function are eliminated with chemotherapy (7 days) and total body irradiation (3 days) so the patient's immune system cells will not fight the tumor-fighting cells they are given in treatment. * 1 to 3 days after total body irradiation, patients receive the tumor-fighting cells by intravenous (IV) infusion. After the cells are infused, they receive interleukin-2 (IL-2) infusions every 8 hours for 5 days. * 2 days after infusion of the tumor-fighting cells, patients receive the stem cells collected earlier by apheresis. * Patients are evaluated 4 to 6 weeks after cell infusion to look for tumor response to treatment. Patients whose tumor has not grown return to the National Institutes of Health (NIH) every 1 to 3 months for blood tests, scans and x-rays.

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 has been highly correlated with the ability to eliminate large tumors in murine models, we have been conducting a clinical trial, 04-C-0288, in which 200cGy of total body irradiation is used in conjunction with the same cyclophosphamide and fludarabine regimen used in our prior adoptive cell therapy trials which have demonstrated significant clinical responses. We have measured T-regulatory cells in patients participating in 04-C-0288 and have demonstrated that despite the addition of 200cGy total body irradiation (TBI), T-regulatory cells promptly reconstituted in the host. Complete clinical responses have not been significantly improved over other adoptive cell therapy regimens. Thus, in this trial we would like to more adequately test our hypothesis that more intensive lymphodepletion will increase complete responses and persistence of the transferred cells. Objective: To determine whether tumor reactive lymphocytes infused in conjunction with the administration of high-dose IL-2 in patients who have received prior therapy with IL-2 and those who have not may result in complete clinical tumor regression in patients with metastatic melanoma receiving a myeloablative lymphoid depleting preparative regimen. To evaluate the safety of the treatment in patients receiving the myeloablative conditioning regimen, cell transfer and IL-2. To determine the survival in patients, of infused cells following the administration of the myeloablative regimen, using analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS). Eligibility: Patients who are greater than or equal to 18 years of age who have tumor reactive cells available, with metastatic melanoma, and are physically able to tolerate high-dose IL-2. Design: Patients will be assigned to one of two cohorts, those having received prior therapy with IL-2 and those who have not. Patients will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days IV), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Patients will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses). On day 1 of patients will receive intravenous administration of cryopreserved autologous CD34+ cells. A complete evaluation of evaluable lesions will be conducted 4-6 weeks after cell infusion. Patients will be enrolled into two strata, using a phase II optimal design to rule out a modest CR rate of 24%, with 33-54 patients enrolled in each strata.

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 regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses). arm 2: Patients that have not 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 regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)

[ 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

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 removed. PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin before surgery works in treating patients with advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

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 * Determine the frequency and severity of toxicity associated with this regimen in patients who are high-risk surgical candidates or in patients unlikely to achieve optimal surgical cytoreduction. * Determine if extreme drug resistance assay profiles change after neoadjuvant chemotherapy. * Determine how thrombospondin-1 (TSP-1), tumor protein 53 (p53), and tumor vessel density change after administration of neoadjuvant chemotherapy. * Assess the quality of life of patients receiving neoadjuvant chemotherapy. * Obtain estimates of tumor response after administration of neoadjuvant chemotherapy. * Determine whether serum cancer antigen 125 (CA-125) at the time of cytoreduction is associated with the ability to optimally reduce the patients. OUTLINE: This is an open-label study. Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after the fourth course of chemotherapy, patients undergo interval cytoreductive surgery. Patients who are unable to undergo surgery receive 2 additional courses of chemotherapy and are re-evaluated for surgery after the sixth course of chemotherapy. Within 4 weeks after surgery, patients receive 2 additional courses of chemotherapy. Quality of life is assessed periodically. Tumor samples are obtained via laparoscopic or percutaneous biopsy prior to beginning chemotherapy and during interval cytoreduction. Tissue is examined by immunohistochemistry staining for p53, TSP-1, microvessel density (CD31), angiogenesis, membrane protein BCL-2, and multidrug resistant gene 1 (MDR-1). Gene array analysis and extreme drug resistant assays are also performed. After completion of study treatment, patients are followed every 3 months for 2 years.

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 fallopian tube cancer Brenner tumor

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 collected for extreme drug resistant assay (EDR) and A1 assays for analysis

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 the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the EGFR pathway are effective strategies in at least a proportion.

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 completing 2 courses (6 weeks) of treatment. Patients with an objective tumor response or stable disease will continue treatment for another 2 courses. Patients will be re-evaluated after 4 courses and those with objective tumor response or stable disease will stop chemotherapy with paclitaxel/carboplatin and continue treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of 12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12 weeks.

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

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 polyphenon E work in preventing lung cancer in former smokers with chronic obstructive pulmonary disease.

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 chronic obstructive pulmonary disease. Secondary * Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on body antioxidant status (carotenoids, vitamins A and E, ascorbic acid \[vitamin C\] and antioxidant enzymes \[catalase and glutathione peroxidase\]) in blood in these patients. * Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on gene expression of markers of proliferation and apoptosis in induced sputum in these patients. Tertiary * Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on lung function in these patients. * Evaluate the relative adherence to use of green tea beverage vs polyphenon E capsules in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and inhaled steroid usage (yes vs no). All patients receive placebo tea beverage and placebo capsules 4 times a day for 2 weeks. Patients are randomized to 1 of 3 treatment arms after successful completion of the 2-week period. * Arm I (green tea beverage): Patients receive oral green tea beverage and oral polyphenon E placebo daily for 6 months. * Arm II (green tea capsule \[polyphenon E\]): Patients receive oral green tea beverage placebo and oral polyphenon E daily for 6 months. * Arm III (placebo): Patients receive oral green tea beverage placebo and oral polyphenon E placebo daily for 6 months. Patients undergo blood, urine, exhaled breath condensate (EBC), induced sputum, and buccal cell collection at baseline and periodically during study for biomarker/laboratory analysis. Blood samples are analyzed for 8-hydroxydeoxyguanosine (8-OHdG), glutathione peroxidase, and catalase. Urine is examined for F\_2-isoprostanes, 8-OHdG, and tea polyphenols. Induced sputum broncho-epithelial cells are analyzed for gene expression of genes implicated in cellular growth and apoptotic pathway via reverse transcriptase-polymerase chain reaction. EBC samples are examined for F\_2-isoprostane levels. Buccal cells are stored for future analysis. PROJECTED ACCRUAL: A total of 195 patients will be accrued for this study.

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

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. III. Perform molecular correlative studies on tumor tissue (optional) and peripheral blood (required) and identify potential predictive markers for response. OUTLINE: Patients receive PXD101 IV 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. Patients undergo blood collection during course 1 of treatment for biomarker correlative studies. Fetal hemoglobin (hemoglobin F) levels are measured via reverse transcriptase-polymerase chain reaction as a potential predictive marker for response. After completion of study treatment, patients are followed periodically.

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 wild type glioblastoma multiforme or gliosarcoma. * Determine the progression-free survival of patients treated with this drug. OUTLINE: This is an open-label study. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no). Patients receive oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may receive additional erlotinib hydrochloride after 1 year at their physician's discretion. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

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 meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.

[ 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. 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 meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.

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 advanced or metastatic carcinoma of the cervix. III. To document time to progression, early objective progression rate, and, if objective responses are observed, response duration. OUTLINE: Patients receive sunitinib malate orally (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 complete response (CR) or partial response (PR) may receive 2 courses after CR or PR is reached. After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.

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 those receiving placebo.

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 purpose is to assess the efficacy of eszopiclone for the treatment of insomnia and other symptoms of fibromyalgia (FMS) in FMS patients. Participants will be randomly selected to receive eszopiclone or placebo. 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 those receiving placebo.

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 either the 4-mg active nicotine lozenge or matching placebo.

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 (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment

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

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 administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.

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 lispro low mixture (LM) (continuation of analogue formulation used before study enrollment).

[ 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 levels. intervention 3: Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks intervention 4: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks

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 Africa | N/A | N/A Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Konya | N/A | Turkey (Türkiye) | 32.48464 | 37.87135

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

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 article administered once-daily by mouth in cycles consisting of 28 days. Subjects will be enrolled in groups of 3 to 6. Adverse events and dose-limiting toxicities will be assessed from the first single dose.

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 first goal is to establish the safety of zonisamide when used together with alcohol. Our second goal is to test the effect of an acute dose of zonisamide on alcohol consumption and show that it may reduce the consumption of alcohol. To achieve this goal we seek subjects with a history of heavy drinking to be tested on the self-administration procedures described below in two sessions with either zonisamide or placebo. These procedures will involve first, the administration of a challenge dose of ethanol to evaluate the effect of alcohol on performance on neuropsychological tests. This initial challenge will be followed by a period of alcohol self-administration in which the research subject can choose to select either ethanol or another reinforcer, money.

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 model of drinking (Gabriel and Cunningham, 2005). In a study done at our laboratory both topiramate and zonisamide were found to have similar effects on reducing the consumption of ethanol in Wistar rat (Knapp et al., 2004). More recently we found that zonisamide administration decreased alcohol consumption in a limited access model in the C57BL/B6 mouse. These results suggest that zonisamide might be useful as a medication for the treatment of alcohol dependence. Topiramate and zonisamide have some structural similarities with a sulfamate or methane-sulfonamide containing chain respectively attached to cyclic structure. These structural similarities may explain some of their pharmacological similarities including blockade of voltage sensitive sodium channels and low potency inhibition of carbonic anhydrase (Taverna et al., 1999; Dodgson et al., 2000; Schaf et al., 1987; Masudaet al., 1993). Both topiramate and zonisamide promote weight loss (McElroy et al., 2003; McElroy et al., 2004; Gadde et al., 2003). This effect may be a result of neuromodulation of the regulation of alcohol and food shared by these drugs.

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

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 and leads to a restoration of the lost action of GIP.

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 exogenous administration of GLP-1 has shown promising results in attempts to restore the incretin effect. Due to rapid degradation of both incretin hormones by the enzyme dipeptidyl-peptidase IV (DPP-IV), treatment strategies now focus on GLP-1 analogues and prevention of hormone degradation through DPP-IV inhibition. 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 and leads to a restoration of the lost action of GIP. Objective To assess the effect of three months treatment with Januvia®, administered as tablets once daily, on metabolic control in metformin treated patients with type 2 diabetes, measured as increases in incretin hormones and insulin secretion. Efficacy end points Primary efficacy end point in trial part one is the relative increase in meal-induced total GLP-1 secretion after one and twelve weeks of Januvia® treatment. Primary efficacy end point in part two is restoration of the insulinotropic effect of GIP, measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose after 12 weeks of Januvia® treatment. Secondary objectives are examination of GLP-2, somatostatin, glucagon, peptide-YY and two glycaemic control parameters (HbA1c and fasting plasma glucose) Design This is a single centre, randomized, double blinded, placebo controlled trial. The trial consists of two parts, each consisting of three months of inhibitor treatment. In each part, 24 patients, recruited from the Diabetes Outpatient Clinic of Gentofte University Hospital, will be randomized to a treatment supplement of either Januvia® or placebo. Procedures During the trial, patients will be tested with well established procedures. In part one, patients will undergo a standardized meal test and two β-cell secretory capacity tests. In part two, patients will undergo standardized hyperglycaemic GIP, GLP-1 and saline clamps. Safety The trial has a short time span of only three months. With more than ten visits during this time and regular blood sampling, the patients are well monitored.

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 of 3 g/day;PO * Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day * Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily

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 Pulau Pinang | N/A | Malaysia | 102.56667 | 3.55 Putrajaya | N/A | Malaysia | 101.69112 | 2.93527 Seremban | N/A | Malaysia | 101.9381 | 2.7297 Cebu | N/A | Philippines | 121.5961 | 16.75187 Makati City | N/A | Philippines | 121.03269 | 14.55027 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Singapore | N/A | Singapore | 103.85007 | 1.28967 Incheon | Korea | South Korea | 126.70515 | 37.45646 Seoul | Korea | South Korea | 126.9784 | 37.566 Seoul | Korea | South Korea | 126.9784 | 37.566 Seoul | Korea | South Korea | 126.9784 | 37.566 Seoul | Korea | South Korea | 126.9784 | 37.566 Seoul | Korea | South Korea | 126.9784 | 37.566 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Bangkok | N/A | Thailand | 100.50144 | 13.75398

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 (IPAH), or familial PAH (FPAH) who had previously discontinued ERA therapy (bosentan or sitaxsentan) due to increased serum ALT or AST concentrations.

null

Pulmonary Hypertension

null

0

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 | Australia | 150.89345 | -34.424 Frankston | Victoria | Australia | 145.12291 | -38.14458 Nedlands | Western Australia | Australia | 115.8073 | -31.98184 Subiaco | Western Australia | Australia | 115.8268 | -31.9485 Avignon | N/A | France | 4.80892 | 43.94834 La Roche-sur-Yon | N/A | France | -1.42757 | 46.66974 Lyon | N/A | France | 4.84671 | 45.74846 Paris | N/A | France | 2.3488 | 48.85341 Saint-Brieuc | N/A | France | -2.76838 | 48.51513 Acapulco | N/A | Mexico | -91.51028 | 16.11417 Chihuahua City | N/A | Mexico | -106.08889 | 28.63528 Cuernavaca | N/A | Mexico | -99.23075 | 18.9261 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Durban | N/A | South Africa | 31.0292 | -29.8579

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, once every-2-weeks and once every-4-weeks with the once-weekly dosing regimen. Men and women who are diagnosed with anemia associated with chronic kidney disease will participate in this study. Approximately 400 patients will be included. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study of epoetin alfa in patients who are not on dialysis and who are already maintaining anemia with epoetin alfa administered once weekly. The study is 40 to 42 weeks in duration. All eligible patients will be treated with epoetin alfa according to one of the following 3 regimens: once-a-week injection (Group 1), or once every-2-weeks injection (Group 2), or once every-4-weeks injection (Group 3). The maximum volume per injection will not be more than 1 mL, therefore some patients may receive more than one injection per dose. The study treatment includes a period to convert to the new dosing regimen, and a subsequent stable maintenance treatment period. After the initial dose, hemoglobin will be measured on a weekly basis and used to determine adjustments in dose for each patient. The primary hypothesis is that the average change in hemoglobin level in the groups that received epoetin alfa once every 2 weeks or once every 4 weeks is not lower than the change in hemoglobin level in the group that received epoetin alfa only once a week. Adverse events will be monitored throughout the study. Clinical laboratory examinations, vital signs, and physical examinations will be conducted routinely to ensure patient safety. Approximately 1 mL of epoetin alfa will be injected under the skin either once a week, once every 2 weeks, or once every 4 weeks (maximum doses of 20,000 IU once a week, 40, 000 IU every 2 weeks, or 80,000 IU every 4 weeks, respectively) for up to 36 weeks of treatment.

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

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 a total of 14 visits over 99(+or-1)week. A 24-hr vEEG is only required if the subject has been spasm-free for more than 24-hrs.

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

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 occur in 60-75 % of lupus patients. The development of lupus-related kidney disease (called lupus nephritis) is associated with an overall worse prognosis. SLE is usually treated with drugs that try to block inflammation caused by the immune system. These treatments can create their own problems and they do not cure lupus. The drugs that are often used to treat lupus nephritis include prednisone (steroids), cyclophosphamide (Cytoxan), azathioprine (AZA or Imuran), and mycophenolate mofetil (MMF or Cellcept). The main purpose of this study is to evaluate the safety and tolerability of etanercept compared to placebo in combination with standard of care to treat individuals with active lupus nephritis.

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 treatment of lupus nephritis remains problematic. Despite the use of currently available therapies, patients experience disease relapse. Over time, patients develop significant morbidity from the disease as well as from medications used for treatment. Etanercept, a TNF inhibitor, is proposed as a potential treatment for lupus nephritis. TNF increases the number of reactive B and T cells. TNF levels can be elevated in lupus. Etanercept is believed to work by blocking inflammation, and it is hoped that it will lessen the signs and symptoms of lupus-related kidney disease. The purpose of this study is to evaluate the safety and tolerability of etanercept compared to placebo in combination with standard therapy to treat individuals with mild or moderately active lupus nephritis. This study will last 1 year. Participants will be randomly assigned to receive either etanercept or placebo in addition to their regular medications. Participants will self-administer 50 mg etanercept or placebo injections once a week. They will continue receiving their usual treatment with corticosteroids and either MMF, Mycophenolic Acid, or AZA. Treatment with study medication will occur for 24 weeks. There will be a screening visit followed by a randomization visit, where subjects will receive and learn how to administer the study drug. Subjects will come to the clinic for 9 study visits. A physical exam and blood and urine collection will occur at most study visits. Participants will also be asked to complete a questionnaire on their health at most study visits. Subjects will be contacted by phone 5 times during the 24-week period to assess for adverse events and worsening disease status.

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 mg placebo 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).

[ 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

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 drug has a real effect), sequential cohort exploratory study to evaluate the safety and effectiveness of JNJ-26113100 in the treatment of adult AD that is moderate in severity, including its effect on inflammatory biomarkers (biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease). Participants will be sequentially assigned to 50 milligram (mg) once daily, 100 mg once daily, 100 mg twice daily or 250 mg twice daily cohort and randomly assigned to receive JNJ-26113100 or matching placebo. The total duration of the study will be approximately 8 weeks. Participants will be asked to follow-up at the end of Week 1, 2, 3, 4, 5 and 6. A study termination visit (Day 57) will be conducted at the end of Week 8. Skin biopsies from atopic dermatitis lesions will be collected during the study to assess changes in the inflammatory disease state. Participants developing flares of their disease may be treated with triamcinolone acetonide 0.1 percent ointment twice daily for up to 7 days. Efficacy will be assessed using Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI) and Visual Analog Scale (VAS). Blood and urine samples will be collected for standard safety laboratory tests, to measure the level of drug and effect of the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the study.

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 orally once daily for 6 weeks. intervention 4: JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. intervention 5: JNJ-26113100 (250 mg) capsules orally twice daily for 6 weeks.

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

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 carefully controlled. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. It is now known that a substance made by the body called GLP-1 also helps with this careful balance. Glucagon like peptide-1 works in four ways. First, it helps to stimulate the cells in the pancreas to produce more insulin. Secondly, it helps to "dampen" the glucagon response (glucagon is released after a meal and causes the blood sugar to rise). Thirdly, Glucagon like peptide-1 delays the digestion of food in the stomach. Lastly, it seems to "dampen" the appetite, which causes a person to eat less. Exenatide is a medication that works very similar to Glucagon like peptide-1. Exenatide is FDA approved for use in adults. Study Design: Followed by a baseline study with insulin alone, subjects were randomized to two different doses of exenatide (1.25 and 2.5 µ,g), administered in a double-blinded randomized controlled manner, along with insulin as a single subcutaneous injection. Studies were at least 3 weeks apart. Baseline: At 0800 h, the pre-breakfast insulin bolus was administered based on patient's usual insulin-to-carbohydrate ratio. Post-bolus, subjects drank 12 ounces of a standard liquid meal (Boost High Protein Drink, 360 calories, 50 g carbohydrates, and 12 g fat), enriched with 1 g of \[13C\] glucose within 10 min. Breath samples for 13CO2 analysis were collected in duplicates at 17 time points until 1300 h. Usual insulin basal rates or glargine were maintained during study. On the days subjects received the study drug of 1.25 µ,g (\~0.02 µ,g/kg) or 2.5 µ,g (\~0.04 µ,g/kg) exenatide along with insulin, the prandial insulin was reduced by 20%. Measurements: Plasma glucose was measured using a bedside YSI glucose analyzer (2300 Stat Plus; Yellow Springs Instruments, Yellow Springs, OH) throughout the study at regularly timed intervals. Delta plasma glucose area under the curve (AUC0 -120) was measured for the exenatide treated groups vs. insulin monotherapy.

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 baseline study with insulin alone

[ 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 will be evaluated.

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 evaluated. After a Screening Period of up to 28 days subjects will be hospitalized for two nights. After the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. At the end of maintenance the subjects will be hospitalized for two nights. Afterwards the doses will be continuously decreased. Efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.

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 | Rhode Island | United States | -71.41617 | 41.7001 Houston | Texas | United States | -95.36327 | 29.76328 Concord | New South Wales | Australia | 151.10381 | -33.84722 Adelaide | South Australia | Australia | 138.59863 | -34.92866 Fitzroy | N/A | Australia | 144.97833 | -37.79839 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Hyvinkää | N/A | Finland | 24.86667 | 60.63333 Oulu | N/A | Finland | 25.46816 | 65.01236 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Dresden | N/A | Germany | 13.73832 | 51.05089 Kassel | N/A | Germany | 9.5 | 51.31667 Leipzig | N/A | Germany | 12.37129 | 51.33962 Marburg | N/A | Germany | 8.77069 | 50.80904 Naumburg | N/A | Germany | 11.80979 | 51.14987 Ulm | N/A | Germany | 9.99155 | 48.39841 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539 Zalaegerszeg | N/A | Hungary | 16.84389 | 46.84 Chieti | N/A | Italy | 14.16494 | 42.34827 Milan | N/A | Italy | 12.59836 | 42.78235 Torino | N/A | Italy | 11.99138 | 44.88856 Christchurch | N/A | New Zealand | 172.63333 | -43.53333 Wellington | N/A | New Zealand | 174.77557 | -41.28664 Gdansk | N/A | Poland | 18.64912 | 54.35227 Krakow | N/A | Poland | 19.93658 | 50.06143 Lublin | N/A | Poland | 22.56667 | 51.25 Olsztyn | N/A | Poland | 20.49416 | 53.77995 Szczecin | N/A | Poland | 14.55302 | 53.42894 Warsaw | N/A | Poland | 21.01178 | 52.22977 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Capetown | N/A | South Africa | N/A | N/A Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Pretoria/Gauteng | N/A | South Africa | N/A | N/A Tygerberg | N/A | South Africa | N/A | N/A Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Bristol | N/A | United Kingdom | -2.59665 | 51.45523 Lancashire | N/A | United Kingdom | N/A | N/A Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 London | N/A | United Kingdom | -0.12574 | 51.50853

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

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 objective is to evaluate if there is significant difference in bowel opacification for the two agents.

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 be randomized to receive either a standardized dilution of Gastroview or Omnipaque orally. The two agents will be prepared to have nearly equivalent iodine concentration. No flavoring agent (ie Crystal Light) will be added. The plan is to mix the agents per manufacturer recommendation as follows: Omnipaque 350 26cc in 974 cc of water (9.0g iodine) Gastroview 25cc in 1000cc of water (9.17g iodine) The time the patients start and stop consuming the contrast as well as the volume taken and time from first drink to start of the scan will be recorded by a blinded investigator. Patients will be asked to drink 900cc. Technical staff will report any side effects or complications observed. After completion of the CT scan, patients will fill in a survey rating the taste of the agent on a 5 point scale, and will be asked to report any side effects. Planned rating scale is as follows: * 2=Dislike very much * 1=Dislike moderately 0=Neither like nor dislike * 1=Like moderately * 2=Like very much A taste test between the two agents will then be administered by a blinded investigator. Patients will be given 30 cc of each agent. The order in which the agents are administered will be randomized. Patients will be asked to rate preference, if any, for either agent on a 3 point scale. Potential bias related to which agent was administered for the CT will analyzed from the data. Planned rating scale is as follows: * 1- A is better 0 -no difference * 1- B is better Patients will be contacted by telephone the day after the CT to assess for any delayed side effects such as diarrhea, constipation, and abdominal cramping experienced in the 24 hours following. Bowel opacification will be rated by 2 body imagers blinded to the agent the patient received. Degree of opacification of the stomach, duodenum, jejunum, and ileum will be rated on a 4 point scale. If contrast has reached the colon, ascending, transverse, descending and sigmoid will be similarly evaluated. Four point rating scale is as follows: 0= absent opacification 1. minimal (\<25% of analyzed segments opacified) 2. good (\>25 % and \< 75% of analyzed segments opacified) 3. excellent (\> 75% of analyzed segments opacified) Description of tests/procedures to be performed. Patients will undergo contrast enhanced abdominal pelvis CT as ordered by the referring clinician. Patients will be randomized to either dilute Omnipaque or dilute Gastroview for oral contrast. Both agents will be in a concentration of 9 mg of iodine/ml, and a volume of 900 cc.

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 | 51.15662 Ghent | N/A | Belgium | 3.71667 | 51.05 Hasselt | N/A | Belgium | 5.33781 | 50.93106 Yvoir | N/A | Belgium | 4.88059 | 50.3279 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Vřesina | N/A | Czechia | 18.12569 | 49.82418 Espoo | N/A | Finland | 24.6522 | 60.2052 Helsinki | N/A | Finland | 24.93545 | 60.16952 Oulu | N/A | Finland | 25.46816 | 65.01236 Seinäjoki | N/A | Finland | 22.82822 | 62.79446 Tampere | N/A | Finland | 23.78712 | 61.49911 Blanquefort | N/A | France | -0.63758 | 44.91065 Bordeaux | N/A | France | -0.5805 | 44.84044 La Rochelle | N/A | France | -1.15222 | 46.16308 Lille | N/A | France | 3.05858 | 50.63297 Lille | N/A | France | 3.05858 | 50.63297 Lille | N/A | France | 3.05858 | 50.63297 Marseille | N/A | France | 5.38107 | 43.29695 Marseille | N/A | France | 5.38107 | 43.29695 Marseille | N/A | France | 5.38107 | 43.29695 Paris | N/A | France | 2.3488 | 48.85341 Rennes | N/A | France | -1.67429 | 48.11198 Saint-Émilion | N/A | France | -0.15609 | 44.89258 Toulouse | N/A | France | 1.44367 | 43.60426 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Bonn | N/A | Germany | 7.09549 | 50.73438 Dresden | N/A | Germany | 13.73832 | 51.05089 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Hanover | N/A | Germany | 9.73322 | 52.37052 Leipzig | N/A | Germany | 12.37129 | 51.33962 Magdeburg | N/A | Germany | 11.62916 | 52.12773 Budapest | N/A | Hungary | 19.04045 | 47.49835 Kecskemét | N/A | Hungary | 19.69128 | 46.90618 Szeged | N/A | Hungary | 20.14824 | 46.253 Szentes | N/A | Hungary | 20.2608 | 46.65834 Catania | N/A | Italy | 15.07041 | 37.49223 Pavia | N/A | Italy | 9.15917 | 45.19205 Pisa | N/A | Italy | 10.4036 | 43.70853 Torino | N/A | Italy | 11.99138 | 44.88856 Almere Stad | N/A | Netherlands | 5.21413 | 52.37025 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Apeldoorn | N/A | Netherlands | 5.96944 | 52.21 Den Helder | N/A | Netherlands | 4.75933 | 52.95988 Enschede | N/A | Netherlands | 6.89583 | 52.21833 Nieuwegein | N/A | Netherlands | 5.08056 | 52.02917 The Hague | N/A | Netherlands | 4.29861 | 52.07667 Tilburg | N/A | Netherlands | 5.0913 | 51.55551 Zeist | N/A | Netherlands | 5.23333 | 52.09 Lillestrøm | N/A | Norway | 11.04918 | 59.95597 Oslo | N/A | Norway | 10.74609 | 59.91273 Oslo | N/A | Norway | 10.74609 | 59.91273 Oslo | N/A | Norway | 10.74609 | 59.91273 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 L´Hospitalet Del LLobregat | N/A | Spain | N/A | N/A Manresa (Barcelona) | N/A | Spain | 1.82399 | 41.72815 Mataró-Barcelona | N/A | Spain | N/A | N/A Ourense | N/A | Spain | -7.86407 | 42.33669 Kungsbacka | N/A | Sweden | 12.07612 | 57.48719 Lund | N/A | Sweden | 13.19321 | 55.70584 Malmo | N/A | Sweden | 13.00073 | 55.60587 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Uppsala | N/A | Sweden | 17.63889 | 59.85882 Västerås | N/A | Sweden | 16.55276 | 59.61617 Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Chorley | N/A | United Kingdom | -2.61667 | 53.65 Fisherwick, Lichfield | N/A | United Kingdom | N/A | N/A Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Headington, Oxford | N/A | United Kingdom | N/A | N/A Leeds | N/A | United Kingdom | -1.54785 | 53.79648 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 South Brent | N/A | United Kingdom | -3.83426 | 50.42654 Waterloo, Liverpool | N/A | United Kingdom | N/A | N/A

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, vs. treatment-as-usual with other oral antipsychotics at reducing marijuana use in schizophrenic individuals.

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 also been associated with clinical exacerbations, noncompliance with antipsychotic medications, poor global functioning, and increased rehospitalization rates. While antipsychotic medications are often effective in controlling symptoms of schizophrenia, they are not always effective in preventing substance abuse. Clozapine, an atypical antipsychotic drug, is currently used to treat schizophrenia. Preliminary research has shown that clozapine is more successful at reducing drug relapse rates in individuals with schizophrenia, as compared to other antipsychotic medications, including olanzapine and risperidone. The purpose of this study is to compare the effectiveness of clozapine as compared to other oral antipsychotic treatment, including combinations of up to two antipsychotics, in reducing marijuana use in schizophrenic individuals. This study will enroll individuals with schizophrenia who are currently taking any oral antipsychotic other than clozapine, including those taking up to two oral antipsychotic, and who are also addicted to marijuana. The study will begin with a 1-week assessment phase, during which all participants will continue taking olanzapine or risperidone. Participants will undergo a physical examination and have blood drawn for laboratory tests. Information pertaining to their medical, psychiatric, and substance use history will also be collected. Urine tests and breathalyzers will be used to screen for the presence of alcohol and drugs. Following the assessment phase, participants will be randomly assigned to switch to clozapine or remain on their prestudy antipsychotic for 12 weeks. Participants remaining on their prestudy antipsychotic treatment will continue to receive the same dose for the entire study. Participants taking clozapine will initially receive a daily dose of 12.5 mg, which will be increased to a maximum of 400 mg per day, as tolerated. Study visits will take place once a week. At each visit, medication side effects, physical and psychological symptoms, substance use, treatment services received, and living situation will be assessed. Blood will be drawn for laboratory tests. Drug and alcohol levels will be monitored three times a week through urine and breathalyzer tests. Quality of life questionnaires will be administered once a month.

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

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 condition only

[ 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) continue for 16 weeks on the same atypical antipsychotic treatment prior to the study enrollment.

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 Prague | N/A | Czechia | 14.42076 | 50.08804 Přerov | N/A | Czechia | 17.4509 | 49.45511 Roudnice nad Labem | N/A | Czechia | 14.26175 | 50.42528 Fains-Véel | N/A | France | 5.13333 | 48.78333 Lille | N/A | France | 3.05858 | 50.63297 Limoges | N/A | France | 1.24759 | 45.83362 Montpellier | N/A | France | 3.87635 | 43.61093 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Poitiers | N/A | France | 0.34348 | 46.58261 Strasbourg | N/A | France | 7.74553 | 48.58392 Ellwangen | N/A | Germany | 10.13173 | 48.96164 Werneck | N/A | Germany | 10.09884 | 49.98201 Chania-Crete | N/A | Greece | N/A | N/A Corfu | N/A | Greece | 19.92016 | 39.62441 Budapest | N/A | Hungary | 19.04045 | 47.49835 Gyula | N/A | Hungary | 21.28333 | 46.65 Oviedo | Principality of Asturias | Spain | -5.84476 | 43.36029 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Wetzikon | N/A | Switzerland | 8.79779 | 47.3264 Izmir | N/A | Turkey (Türkiye) | 27.13838 | 38.41273

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/A | Portugal | -8.41955 | 40.20564 Seoul | N/A | South Korea | 126.9784 | 37.566 Southampton | Hampshire | United Kingdom | -1.40428 | 50.90395

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 week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

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

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 approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in adults. Patients may be voluntary inpatients or outpatients at the time of the screening visit, but should have returned to their usual living situation by Day 21 of the double-blind treatment phase. The study duration is approximately 10 weeks. Patients who have completed this study or who were discontinued from this study due to lack of efficacy but have completed at least 21 days of double-blind treatment and are expected to benefit from paliperidone treatment, may enter an optional open-label safety study.

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 Diagnostic and Statistical Manual of Mental Disorders; 4th Edition (DSM-IV) diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, and 295.90) as confirmed by the Kiddie-Sads-Present and Lifetime Version (KSADS-PL), and who should have a Positive and Negative Syndrome Scale (PANSS) score that is between 60 and 120, inclusive, at screening and baseline. Before any study related procedure is performed, the patient and his parent or legal guardian must have provided assent and signed an informed consent form, respectively. The study consists of 3 phases: a screening phase, a 6-week double-blind treatment phase with an end-of-study or early withdrawal visit, and a 1 week follow-up visit for patients who do not enter the optional open-label safety study. In the screening phase, a trained clinician will complete the K SADS-PL interview, including all 5 supplements, to confirm the DSM-IV diagnostic criteria for schizophrenia. In addition, the K-SADS-PL screening diagnostic interview items for suicide must each have a score of \<=2, as follows: item a), recurrent thoughts of death; item b), suicidal thoughts; item c), suicide attempts and their seriousness; item d), suicide attempts and their lethality; and item e) self harming behavior. Women of childbearing potential will undergo a urine pregnancy test at screening, baseline, Week 4, and at end of study or upon early withdrawal from the study. Patients who are receiving prohibited medications, such as antidepressants, lithium, drugs of abuse, and alcohol, will enter a washout period during which medications will be tapered down and eventually stopped. The screening and washout phase may not exceed 21 days. In the double-blind treatment phase, at the baseline visit, the inclusion and exclusion criteria will be reviewed. Patients who continue to meet the criteria will be randomly assigned (as in the toss of a coin) to 1 of 4 dose groups. Patients weighing between 29 to \<51 kilograms (kg) will receive paliperidone ER 1.5, 3.0, or 6.0 milligrams (mg) or matching placebo. Patients weighing \>=51 kg will receive paliperidone ER 1.5, 6.0, or 12.0 mg or matching placebo. Patients will come to the study site for weekly visits during this phase. A follow-up visit will occur 1 week after the end of treatment for those patients who will not enter the open-label study. Efficacy and safety procedures will be performed at specified times during the study. Efficacy procedures include the administration of the PANSS, Children's Global Assessment (CGAS), Clinical Global Impression-Severity (CGI-S) and a sleep visual analog scale. Safety assessments include a physical examination (ECG measurements, vital signs, weight, height, and waist measurements), clinical laboratory testing, drug screen, Simpson and Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), Abnormal Involuntary Movement Scale (AIMS), Tanner Staging, concomitant medications and the recording of adverse events. A Data Safety Monitoring Board will oversee the conduct of the study and review adverse event reports and laboratory test results. The total volume of blood drawn for laboratory evaluation throughout the study, including 10 milliliters (mL) for the optional pharmacogenomics testing, is approximately 66 mL for each patient. Blood samples will be collected to explore the pharmacokinetics of paliperidone in adolescent patients. The study hypothesis is that at least 1 paliperidone ER dose group will be superior to placebo in improving the symptoms of schizophrenia as measured by the change in total PANSS score from the baseline to endpoint (Week 6). Paliperidone ER 1.5, 3.0, 6.0, or 12.0 mg or matching placebo will be administered daily in the morning before 10 a.m., and at approximately the same time each day. Study drug administration should occur in a consistent manner relative to the intake of food (i.e., either before or after breakfast, or without any breakfast) throughout the study. Study drug should be swallowed whole and with water. Study drug will be administered for 6 weeks.

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 | -77.03637 | 38.89511 Lake Charles | Louisiana | United States | -93.2044 | 30.21309 Boston | Massachusetts | United States | -71.05977 | 42.35843 Cleveland | Ohio | United States | -81.69541 | 41.4995 Portsmouth | Virginia | United States | -76.29827 | 36.83543 Spokane | Washington | United States | -117.42908 | 47.65966 Bangalore | N/A | India | 77.59369 | 12.97194 Chennai | N/A | India | 80.27847 | 13.08784 Hyderabad | N/A | India | 78.45636 | 17.38405 Hyderabad Andra Pradesh | N/A | India | N/A | N/A Mangalore | N/A | India | 74.85603 | 12.91723 New Delhi | N/A | India | 77.2148 | 28.62137 Varanasi | N/A | India | 83.01041 | 25.31668 Bucharest | N/A | Romania | 26.10626 | 44.43225 Ekaterinburg Na | N/A | Russia | N/A | N/A Kazan' | N/A | Russia | 49.12214 | 55.78874 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow Russia | N/A | Russia | N/A | N/A Nizhny Novgorod | N/A | Russia | 44.00205 | 56.32867 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saratov | N/A | Russia | 46.00861 | 51.54056 Smolensk Region N/A | N/A | Russia | N/A | N/A Stavropol Na | N/A | Russia | N/A | N/A Tomsk Na | N/A | Russia | N/A | N/A Yaroslavl | N/A | Russia | 39.87368 | 57.62987 Hlevakha | N/A | Ukraine | 30.32706 | 50.27423 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Odesa | N/A | Ukraine | 30.74383 | 46.48572 Simferopol | N/A | Ukraine | 34.11079 | 44.95719

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

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 the contents of the supplied syringes. Treatment assignments consist of three groups: * Ropivacaine: 30 ml 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; * Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block; * bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block. * bupivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block; All solutions for interscalene block will contain epinephrine 1:400,000 as a marker for intravascular injection. Insulated needles with nerve stimulation will be used. Motor response in the surgical limb at a current of \< 0.4 mA at 0.1 msec duration will be considered evidence of adequate needle position. Patients will be evaluated at 5-minute intervals for 15 minutes for development of sensory and motor block. Sensory block will be assessed by loss of sensation to pinprick over the deltoid muscle. Motor block will be assessed by evaluation of ability to abduct the shoulder, the so-called "deltoid sign". During surgery, patients will receive either general anesthesia or sedation at the discretion of the attending anesthesiologist. Demographic variables, morphometric measurements, and the specific type of procedure will be recorded. The intraoperative management strategy (i.e. general anesthesia versus sedation) and the total doses of fentanyl, midazolam, morphine, and propofol administered perioperatively will be recorded. Finger-stick blood glucose will be measured upon arrival in the postanesthesia care unit (PACU). The primary outcome will be the duration of the interscalene nerve block, which will be measured by time from onset of sensory block until first administration of analgesic medication. The severity of postoperative pain will be assessed by a blinded observer using a verbal response score (VRS) at 10-minute intervals for 30 minutes in the PACU. Patients reporting pain scores greater than 2 will be given intravenous morphine (1-2 mg) every 5 minutes until they are comfortable. After discharge from the PACU pain unrelieved by oral medication (VRS persistently greater than 4) will be treated with intravenous morphine. Outpatients will receive a prescription for oral acetaminophen with oxycodone. A blinded observer will interview patients each morning for three days postoperatively. Data collected will include time of block duration,the primary outcome; defined as time from onset of sensory blockade to first administration of supplemental analgesic medication after PACU discharge, as well as secondary outcomes: time to a significant increase in shoulder discomfort, time to a noticeable decrease in numbness and/or weakness, maximum VRS with rest and movement, and total opioid consumption. The times and VRS scores for secondary outcomes will be based on patient reporting of the corresponding events daily. A member of the study staff will contact patients at 14 days postoperatively to assess for any late or persistent complications such as residual sensory or motor block.

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 and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block; arm 3: bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block. arm 4: bupivacaine 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

[ 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

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 corticosteroid-dependent asthmatic subjects. The objective of this study is to evaluate the therapeutic equivalency of the 100 mcg and 200 mcg MF DPIs when providing the same total daily dose (400 mcg/day).

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 weeks arm 3: 2 inhalations of placebo matching 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

[ 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 acid for 6 additional weeks at an increased dosage, totaling an overall treatment time of 16 weeks as well.

[ 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 acid treatment. Quality of life is assessed at the end of every week through a study diary. Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months.

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 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Tianjin | N/A | China | 117.17667 | 39.14222

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 provide long-term safety data for PN400 in order to gain regulatory approval to make PN400 available for clinical use in this subject population.

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 to 60 minutes before dinner. Tablets should be swallowed whole and not broken, crushed or chewed. intervention 2: 500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months

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 formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.

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 throughout the study.

intervention 1: Ticagrelor Tablets intervention 2: Clopidogrel (over encapsulated) capsule intervention 3: Aspirin Tablets

9

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 dihydrochloride alone.

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 sapropterin dihydrochloride alone. Each subject received each regimen; the 2 treatment groups varied only in the sequence of the 2 regimens. The washout period between treatment regimens comprised the 1 day period between the last dose of study drug under the first regimen and the first dose of study drug under the second regimen (Day 14 morning to Day 15 morning).

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 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.

[ 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 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 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 received ARV treatment).

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 patients. There will be an optional open-label extension phase to evaluate effectiveness, safety and tolerability of continued tenofovir/emtricitabine with darunavir/ritonavir all dosed once daily for 48 weeks. This study will be conducted in the United States at up to 5 sites where 20 patients will initially receive TMC125 400mg with tenofovir DF/emtricitabine FDC 300/200 mg all dosed once daily for 14 days. On Day 15, a blood sample will be obtained and intensive TMC125 pharmacokinetic (PK) values and fasting lipids (check of total cholesterol, direct LDL, HDL, triglycerides) following a 10 hour fast (no eating) will be assessed. Patients will then add darunavir / ritonavir 800/100 mg once a day to the regimen for Days 15 - 29. On Day 29 intensive PK sampling for TMC125, darunavir and ritonavir will be performed and fasting lipids will be evaluated. On Day 29, patients will discontinue TMC125 and continue darunavir/ritonavir 800/100 mg and tenofovir DF/emtricitabine FDC 300/200 mg all dosed once daily. On Day 43, fasting lipids will be assessed. At this point, patients may enter the optional open-label extension phase of the study and continue treatment with darunavir/ritonavir 800mg/100 mg and tenofovir DF/emtricitabine FDC 300/200mg all dosed once daily through 48 total weeks of treatment. The study will consist of a total of 8 visits including 2 intensive PK visits. Within 4 weeks after the Screening Visit, the study site should have received all data to determine a patient's eligibility for the study. The Baseline Visit (Day 1) will be followed by a study visit on Day 8. An intensive PK visit will occur on Day 15. After modification of therapy on Day 15, a study visit will occur on Day 22. A second intensive PK visit will occur on Day 29. On Day 43 a study visit will occur at which point study therapy will be discontinued unless the patient elects to continue in the optional open label extension phase of the study. Patients electing to continue in the open-label extension will have 4 additional study visits at Week 12, 24, 36 and 48. All patients will be asked to return for a 4-week follow-up visit after the completion of study treatment. During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for effectiveness and safety will be done at regular visits as well as blood pressure monitoring. All patients will receive TMC125 400 mg orally (by mouth) once daily. Tenofovir DF 300mg/emtricitabine 200mg will be dosed once daily orally as the fixed dose combination. Darunavir/ritonavir will be dosed 800/100 mg orally once daily. All doses should be administered following a meal.

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 treatment dose \& 2 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 3: Each patient will receive 1 active treatment dose \& 2 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 4: Each patient will receive 1 active treatment dose \& 2 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 5: Each patient will receive 1 active treatment dose \& 2 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.

[ 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 12 weeks intervention 4: Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks intervention 5: Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

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

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 in choosing one regimen over another.

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 (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin aspart intervention 4: Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin detemir

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 with schizophrenia 3) To examine the efficacy of rimonabant for neurocognitive impairments in people with schizophrenia treated with second-generation antipsychotics (secondary outcome) 4) To examine the efficacy of rimonabant for patient perceived health outcomes and quality of life (secondary outcome) 5) To test the effect of rimonabant on cigarette smoking, nicotine dependence and nicotine craving in people with schizophrenia 6) To examine the effects of rimonabant on food satiety in people with schizophrenia There is an increasing awareness of the problem of metabolic issues in people with schizophrenia and renewed focus on physical health care for this population. There is under-treatment, in general, of medical conditions in people with schizophrenia, and increased mortality from natural causes. People with schizophrenia are at risk for developing obesity due to many factors including inactive lifestyle, poor dietary choices, and side effects of the commonly used atypical antipsychotics. Metabolic syndrome has been discussed in the cardiology and endocrinology for over two decades, but its prevalence in the mentally ill is only now being fully realized. Diabetes mellitus may be twice as prevalent among patients with schizophrenia as in the general population and metabolic syndrome is probably even more prevalent than diabetes among people with schizophrenia. There is now an opportunity to address this serious problem. A new drug, rimonabant, has recently been approved in several European and Latin American countries. This drug represents the first of a new class of psychoactive drugs witch may improve metabolic problems through decreasing appetite drive. This may also help decrease the drive for cigarette use, which is also a great problem for people with schizophrenia. Is this a safe and effective treatment in this population? This study proposes to test this question in a rapid study, which will develop the basis for future work in this important area.

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 blood will be taken for laboratory tests. Women will have a pregnancy test. This part of the study is 3-4 visits. The time of the visits will be about 8 hours. Part II is a 16-week treatment phase subjects will be randomly assigned to either rimonabant or placebo for a 16-week period. The medication will be given in unmarked capsules so that subjects will not know which medication they are receiving. Only the pharmacist will know which medications subjects are receiving. If an emergency occurs we will break the blind and give appropriate care. This phase will require one visit every week and each visit may take up to 2-3 hours. Subjects will be examined every week to check symptoms side effects. Subjects symptoms will be evaluated using specially designed rating scales, to ask about their daily experiences and feelings. Evaluations that occur every 4 weeks may take about 2 hours. At week 8 and week 16 laboratory tests will be repeated. These tests will be compared to the baseline tests taken in Part I. The end of study tests may take up to a total of 8 hours and may require 3-4 visits. All testing is done for research purposes only and would not be performed if subjects were not participating in this study. The total number of visits requested for this study will be 16-20. When subjects undergo neuropsychological testing, we will examine their ability to learn and remember numbers and words to pay attention and to quickly perform motor tasks. A motor task is when you use your hands to perform a task such as placing pegs into a piece of wood. These tests will take about 2 hours and are done at the beginning of Part I and the end of Part II. Diet and exercise counseling will be held weekly for groups and individuals. Sessions will focus on topics such as calories, fat content, portion control and determining a healthy weight. We will request that participants maintain a food diary and exercise approximately 30 minutes/3 times per week. Subjects will be encouraged to attend the counseling sessions. Transportation will be available for subjects. If patients have not attended sessions, they will be reeducated on the importance of attending sessions at the time of clinical ratings.Subjects will not be discharged from the study if they do not attend sessions. Randomization will be done using a permuted block randomization system, and will be stratified by clozapine/olanzapine treatment at baseline. Treatment assignment order is random within each block, and the total number of patients assigned to each treatment is equal. The block sizes will vary between sizes 2 and 4 in random sequence. The unblinded pharmacist will be notified of the treatment assignment, and will inform unblinded pharmacists at the other sites about which study medication to dispense. In an emergency, research staff will be able to contact the pharmacy for unblinding. Rimonabant will be available in 20 mg capsules with matched placebo. For outpatients study medication will be dispensed on a weekly basis plus two extra days of medication. Inpatient subjects will receive their study medication daily from the Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) central pharmacy by a non-blind pharmacist. The blind will be broken only if a medical emergency requires this information. If this occurs, the patient will be withdrawn from the study. All raters, investigators and other staff will be blind to treatment assignment except for the pharmacist. The pharmacist does not participate in assessing any of the primary symptom or side effect dependent variables and conveys no information about treatment assignment to patients or staff except in a medical emergency. Patients receiving 75% of their assigned medication will be considered compliant. Outpatient compliance will be monitored through weekly pill counts and subject interviews. Inpatient compliance will be monitored through inpatient medication records. If a patient is observed to be non-compliant then this will be discussed with the patient and a plan formulated to bring the patient back within the compliance parameter. For outpatients the plan may include contacting the patients caretaker or scheduling increased clinic visits. These monitoring procedures have been used in other MPRC studies and have resulted in high levels of compliance. Compliance patterns will be carefully monitored in each treatment group and will be described as part of any presentation of study results. Satiety is defined as the reduced willingness to eat after a meal, not due to sickness or other extraneous factors and can be thought of as sensations of fullness. A preload and a test meal will be used in this study. The preload is a fixed amount of food given to the participant that is consumed in its entirety. The test meal is a food or foods served, following the preload, in sufficient quantity so that the participant can eat as much as desired. The amount consumed of the test meal is measured and used as an index of satiety. Likert and Visual Analog Scales (VAS) will also be used. We will employ both the preload-test meal paradigm along with rating scales in the present study to investigate the effects of rimonabant on satiety signaling. The testing will occur at baseline, week 8, and week 16 to see if the effect changes. All three testing occasions will be the same. Participants will arrive after skipping breakfast and given a preload of 12 oz. of Ensure (375 kcal) served chilled in a large, plastic cup. Hunger ratings will be taken at baseline, then every 30 minutes for 90 minutes. After 60 minutes a test meal consisting of a pre-weighed bowl each of Reduced Fat Wheat Thins and Nilla Wafers will be given. These will be kept in separate bowls so that exact caloric consumption can be measured. The test meal will be served with 12 oz. of water served chilled in a large plastic cup. Satiety will be assessed by the quantity of Wheat Thins, Nilla Wafers, and water consumed and the difference between the hunger rating score from baseline for each time point. About 75% of subjects will be smokers. Smoking measures will be performed on those with \>8 ppm CO in expired breath and who smoke at least 5 cigarettes daily. One approach to studying tobacco craving in the laboratory is to compare smokers responses when exposed to neutral and smoking-related in vivo cues. In vivo or "real-life" cues are either presented by the experimenter or involve manipulation of materials by the participant. For this study, after smoking a cigarette at baseline (15 minutes before testing begins), patients will be asked to complete the Tobacco Craving Questionnaire (TCQ) and the Positive and Negative Affect Schedule (PANAS). Participants will then be exposed to two experimental trials presented in random order: 1) smoking cues, and 2) neutral cues.Each trial will last 20 minutes. Participants will complete the TCQ and PANAS immediately and 10 and 20 minutes after cue exposure. There will be a rest period between trials. During the rest period, the patient will complete other study assessments lasting 30-60 minutes. After the assessments, the patient will smoke again and then will complete the ratings and cue reactivity session for the second random condition at the same time points (baseline, immediately after, 10 and 20 minutes).Trials will begin with the experimenter placing a tray containing an opaque cover on a table in front of the participant. In the smoking cue condition, a pack of the participants preferred brand of cigarettes a lighter and an ashtray will be under the tray cover. In the neutral cue condition, a pack of unsharpened pencils and a pencil sharpener will be under the cover. When instructed, the participant will lift the cover on the tray. In the smoking cue condition, participants will take one cigarette out of the pack light it without puffing hold it and look at it. At the end of the exposure period participants will extinguish the cigarette, and replace the cover on the tray. In the neutral cue condition, participants will take one pencil out of the pack sharpen it hold it and look at it. The Iowa Gambling Task (IGT) is a computer-administered cognitive test that measures risk-reward decision-making. Performance is impaired in patients with brain lesions in the ventromedial prefrontal cortex and in people who abuse alcohol, cocaine, marijuana, methamphetamine, opiates, or multiple illegal drugs. Patients with schizophrenia show normal IGT performance in some studies. In particular, adolescent patients and adults with catatonic schizophrenia show impairment. One study found that IGT performance was significantly correlated with negative symptoms. In this study, subjects will take one of two equivalent versions of the IGT at study entry and study completion. Each task session will take up to 30 minutes. The Tobacco Craving Questionnaire (TCQ) is a questionnaire designed to assess current tobacco craving. Factor analysis of the 47-item TCQ resulted in four factors: 1) emotionality, smoking in anticipation of relief from withdrawal or negative mood; 2) expectancy, anticipation of positive outcomes from smoking; 3) compulsivity, an inability to control tobacco use; and 4) purposefulness, intention and planning to smoke for positive outcomes. We will use a 12-item version of the TCQ, comprising the three items from each factor that exhibited optimal within-factor reliability (Cronbachs coefficient alpha) and inter-item correlation. The 12-item TCQ is as valid and reliable as the 47-item version. TCQ items are rated on a scale from 1 strongly disagree to 7 strongly agre. Factor scale scores for each participant are obtained by summing the three items. The PANAS is a 20-item scale in which 10 items describe positive mood (enthusiastic, interested, determined, excited, inspired, alert, active, strong, proud, attentive) and 10 items describe negative mood (scared, afraid, upset, distressed, jittery, nervous, ashamed, guilty, irritable, hostile). Each item is rated on a 5-point scale (not at all, a little, moderately, quite a bit, extremely). The PANAS shows high internal consistency and test-retest reliability. Subjects can leave the study at any point. If a participant experiences worsening of psychotic symptoms (relative to the baseline BPRS, an increase of 3 points or more OR an increase from a 5 to 7 on any one of the following BPRS items: somatic concern, conceptual disorganization, hostility, suspiciousness, hallucinatory behavior, or unusual thought content OR an increase of 2 or more on the CGI global severity OR the subject is judged to be entering an exacerbation of his/her illness by the treating clinician), the patient will be discontinued from the study. Other reasons for study termination include evidence of suicidal thinking or behavior, or the development of or worsening of significant depressive symptoms (score at any point in the study of \>10 on the CDS or a 3 on the suicidal item), complete cessation of eating and drinking for \> 24 hours, pregnancy, or blood pressure \> 165/95 on three consecutive readings. Once a participant is discontinued from the study for whatever reason, completion ratings will be performed. This includes laboratory tests rating scales and neurocognitive assessments. If a patient is prematurely terminated from the study, they will resume their standard treatment. At the end of the study patients will not have the option of continuing rimonabant because it is not FDA approved in the US. Other interventions to improve weight and metabolic profiles will be discussed with the patients.

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

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 can be evaluated, typically over the first few days of therapy. Fluid restriction may be reinstituted at any time in subjects whose sodium fails to improve or worsens with study therapy. A forced-titration up to 60 mg of study drug by day 3 to 7 will be based on the subject's serum sodium Subjects entering the study with a serum sodium concentration less than 130 mEq/L\[mmol/L\] may be fluid restricted if necessary at the discretion of the Investigator. Subjects should be monitored closely during the first 24 hours of treatment for dosing titration. The total dosing duration will be up to 21 days (plus 3 day treatment window). Subjects will return to the clinic on Day 22 (+3 days) for assessments and will complete a follow-up visit on Day 28 (+2 days).

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

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 | 34.4 Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Ibaraki | N/A | Japan | 135.56828 | 34.81641 Kagoshima | N/A | Japan | 130.55 | 31.56667 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kyoto | N/A | Japan | 135.75385 | 35.02107 Miyagi | N/A | Japan | 128.18236 | 26.62566 Niigata | N/A | Japan | 139.04125 | 37.92259 Okayama | N/A | Japan | 133.93333 | 34.65 Osaka | N/A | Japan | 135.50107 | 34.69379 Ōita | N/A | Japan | 131.6 | 33.23333 Saitama | N/A | Japan | 139.65657 | 35.90807 Shizuoka | N/A | Japan | 138.38333 | 34.98333 Tochigi | N/A | Japan | 139.73333 | 36.38333 Tokushima | N/A | Japan | 134.56667 | 34.06667 Tokyo | N/A | Japan | 139.69171 | 35.6895 Toyama | N/A | Japan | 137.21667 | 36.7

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 administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

intervention 1: placebo intervention 2: pregabalin intervention 3: pregabalin

49

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 versus a currently marketed drug follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.

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: Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days. intervention 3: Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days. intervention 4: Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days. intervention 5: Follitropin alfa (Gonal-f®) 75 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 10, 20, 30 and 40 mcg will also receive daily dose of follitropin alfa 75 IU subcutaneously from Stimulation Day 7 (S7) up to S14. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days. intervention 6: Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm).

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 induced DH vs placebo in a randomized crossover double blinded study.

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 metronome paced hyperventilation induced dynamic hyperinflation. We will also evaluate the effect of tiotropium induced increase in IC (inspiratory capacity) vs extent of emphysema as evaluated on high resolution thin section CT lung

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

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 primary and most potent estrogen

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 means that it will test a drug - in this case, temozolomide -- that has already been studied and shown to be safe. Surgery, when possible, is the main treatment for patients with melanoma like yours. In most people, however, melanoma cells have already spread to other places in the body. This means that even with surgery, many people will have the melanoma come back. This is often fatal. One goal of this trial is to treat the melanoma cells that might have spread before they have a chance to grow. As part of this trial, we also study which genes are turned on and which genes are turned off in your tumor. We will obtain tumor from the biopsy done before you started temozolomide treatment and from the tumor removed during the surgery done after you finish temozolomide treatment. This may help us understand how temozolomide works and how to recognize which tumors will respond. Before and during the temozolomide treatment, we will also test a new way of measuring the amount of tumor present. This involves a special way of analyzing the CT scan which you will have anyway. This new technique may allow us to see tumor shrinkage very early in the treatment course.

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 TMZ and then undergo resection of residual disease. The primary endpoint will be tumor response as measured by the RECIST criteria. Patients will be seen monthly.

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 will be re-evaluated for response. Responding patients will be offered another cycle of treatment. Patients will be treated until best response, progression of disease, or 6 cycles, whichever comes first. After completing temozolomide treatment, patients will be evaluated for surgical resection. It is expected that, unless there is progression of disease, patients will undergo resection (i.e. therapeutic lymph node dissection). In patients who have a complete clinical response to temozolomide, whether or not to do a subsequent lymph node dissection will be left up to the discretion of the surgeon and the patient.

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 of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled; only about one-third of patients continue to maintain control successfully. TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker that was shown to be a orally active antihypertensive agent with a prolonged duration of activity and good safety tolerability in a recent clinical study. Chlorthalidone is a thiazide-like diuretic that reduces blood pressure by decreasing intravascular volume through urinary salt and water excretion. By combining this action with azilsartan medoxomil, a greater reduction in blood pressure is expected than with either agent alone. For subjects requiring combination therapy, azilsartan medoxomil plus chlorthalidone offers a novel combination that may provide a more potent and safe combination for blood pressure reduction. This study is being conducted to determine whether administration of azilsartan medoxomil in combination with chlorthalidone to subjects with uncontrolled hypertension is more effective in reducing blood pressure than chlorthalidone alone. This study is also being conducted to evaluate the safety and tolerability of azilsartan medoxomil combined with chlorthalidone. Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 10 Weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations, electrocardiogram. Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at 24 hour intervals.

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 placebo-matching tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks. intervention 3: Chlorthalidone 25 mg, tablets, orally, once daily; azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily and azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily for up to 6 weeks.

intervention 1: Azilsartan medoxomil and chlorthalidone intervention 2: Azilsartan medoxomil and chlorthalidone intervention 3: Chlorthalidone

46

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

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

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, we have learned that obese or overweight persons make too much leptin, which may contribute to insulin resistance. Paradoxically, patients who do not have any fat cells, also have insulin resistance. In these patients, insulin resistance is caused by the absence of leptin and leptin replacement significantly improves insulin resistance and fat deposition in the liver. In an earlier study, we determined the leptin levels in patients with NASH and how these levels are related to body fat levels as well as responsiveness to insulin. We saw that a subgroup of patients with NASH have relatively low levels of leptin in contrast to the amount of body fat they had. We now would like to see if restoring leptin levels to normal will improve the disease process in these patients. Our study patients will be male patients, aged between 18 and 65 (inclusive), who do not have any other cause for their liver disease. We have put some restrictions in body size such that a spectrum of patients from normal weight to obese range would be included. They will also demonstrate low leptin levels (levels similar to only 25% of normal population). We will use a genetically engineered form of leptin manufactured by Amylin Inc. given via injections under the skin. We plan to continue therapy for a period of one year and evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic parameters and body composition characteristics that we examined in our earlier study. We expect that patients with low blood leptin levels will show improvement in their liver disease and insulin resistance when their blood leptin levels are restored to normal.

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 results compared to continuation of corticosteroids (also known as prednisone maintenance) and standard maintenance immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin).

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 disease, hyperlipidemia (elevated lipid levels such as cholesterol and triglycerides), obesity (overweight), acne, and susceptibility to infections. It is hoped that the new generation of potent immunosuppressive medications (such as Prograf and CellCept) will permit avoidance or withdrawal of corticosteroids for the majority of patients to avoid both short- and long-term complications of corticosteroid use in kidney transplant recipients.

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 for a total of 3 to 5 doses. Participants also began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued indefinitely. The steroids were initially given in the operating room intravenously at time of transplant as Solu-medrol (methylprednisolone)and were then switched to daily oral prednisone doses. The participant's dose of prednisone was rapidly decreased until it was completely eliminated by day 6 post-transplant. arm 2: Participants randomized to the prednisone maintenance group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was initiated intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered an inpatient or outpatient for a total of 3 to 5 doses. Participants began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued on them indefinitely. The steroids were initially given intravenously in the operating room at time of transplant as Solu-medrol (methylprednisolone) and were then switched to daily oral prednisone tablets. Participants remained on all drugs according to their doctor's standard of care, and the prednisone was not be eliminated.

[ 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, 40mg on day 4, 20mg on day 5, none from day 6-on. intervention 2: Participants in both groups received 3 to 5 doses of an intravenous medication to prevent rejection called Thymoglobulin (rabbit antithymocyte globulin) as per our standard of care. This drug was dosed at 1.5 milligrams/killograms per dose and dosing was then based on body weight. The dose was decreased in half or held if the participant had a low white blood cell count or if the participant a low platelet count. The first dose was given intravenously in the operating room and subsequent intravenous doses were administered either while participants were inpatients or outpatients for a total of 3 to 5 doses for a total of up to 6mg/kg. The number of doses was based on transplant kidney function and risk factors for rejection. intervention 3: Participants in both groups received tacrolimus per our standard of care. This medication helped to prevent rejection and was initially dosed at 0.1-0.2 milligrams/killograms/day in two divided doses, given orally, based on participant's body weight. We then looked at the trough levels of this medication(the lowest level before the next dose), and aimed to keep the trough level between 5-10 nanograms/milliliter throughout the study. intervention 4: Participants in this group continued on prednisone indefinitely. Participants began with 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, 40mg on day 4, 20 mg days 5-9, 15 mg day 10-19, 10 mg day 20-24, 7.5 mg day 25-29, and 5mg from day 30-on indefinitely. intervention 5: Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone withdrawal group was 1000mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea. intervention 6: Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone maintenance group was 500 mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.

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

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, participants could elect to enroll in an open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or elected not to enroll in the open-label extension study or who discontinued during the 28-week treatment period were followed in this study for 24 weeks from administration of the last dose of study drug.

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 that presents in childhood with total cholesterol typically in the 650 to 1000 mg/dL range. This was a randomized, double-blind, placebo-controlled study, which consisted of a 4-week screening period, 26 weeks of treatment, and a 24-week post- treatment follow-up period (with the exception of patients who enrolled in the open-label extension study, Study 301012-CS6; NCT00694109). Eligible patients were randomized in a 2:1 ratio to receive 200 mg mipomersen or matching volume placebo subcutaneous (SC) injections weekly. Patients who weighed \<50 kg received a lower dose of 160 mg mipomersen or matching volume of placebo SC injections weekly. Patients were to have been on a stable (\>=12 weeks) regimen of allowed lipid-lowering therapies at screening, and were required to remain on the same dose and regimen throughout the study. Patients returned to the study center for clinical evaluation every other week during the first 4 weeks of treatment, once every 4 to 5 weeks for the remainder of the treatment period, and monthly during the post-treatment evaluation (follow-up) period. The primary endpoint assessment was at Week 28. Following treatment and Week 28 evaluations, eligible patients who tolerated the study drug could elect to enroll in the open-label extension study (Study 301012-CS6; NCT00694109). Patients who did not participate in the open-label extension study were required to return to the study center for clinical evaluation at least twice during the post-treatment follow-up period, including an end-of-study termination visit at the end of this 24-week period.

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 Metabolism Disorders

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 subcutaneous injection.

intervention 1: mipomersen intervention 2: Placebo

10

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 the United States under the FDA monograph.

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 staining and Schirmer testing, will be done and evaporometry assessments will be completed to determine baseline tear evaporation rate. This will occur before any test article is administered to the patient. Qualified patients will be randomized into two treatment groups. After 1 hour, in order to eliminate any residual sodium fluorescein, patients will be administered one drop of Systane® (40 µl) or Optive™ (40 µl) in each eye per randomization assignment. At 30 minutes following instillation of the drop, the evaporometry measurement will be repeated. These evaporometry tests (pre and post instillation of drops) will be performed in order to establish a comparison for later analysis. The estimated time in completing each study visit will be 180 minutes per visit. Patients will be asked to return to the clinic after 2 - 14 days for evaluation of the 2nd assigned crossover treatment (i.e. patients who initially received Optive will receive Systane and patients who initially received Systane will receive Optane). During the interim study periods, patients will be asked to continue their pre-study routine; using their pre-study ocular lubricant or other tear products at the same frequency. Any changes in the frequency of product use during the interim period or any changes in other concomitant medications will be carefully recorded. This is especially important since many prescription products (e.g., Claritan) have significant effects on lacrimal gland physiology. An effort will be made to schedule all study visits at approximately the same time of day in order to reduce diurnal variability. For the similar reasons, all patients will be asked not to use any lubricants or ocular medications for at least one hour prior to their office visits.

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 administered using the same procedure protocol. arm 2: Artificial Tears (Systane, 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 (Optive, 40 microliters) will be administered using the same procedure protocol.

[ 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: Instillation of Optive followed by evaporometry assessment after 30 minutes.

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

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

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 | British Columbia | Canada | -122.78217 | 49.2846 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Bay Roberts | Newfoundland and Labrador | Canada | -53.26478 | 47.59989 Mount Pearl | Newfoundland and Labrador | Canada | -52.78135 | 47.51659 St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494 Corunna | Ontario | Canada | -82.43313 | 42.88338 Etobicoke | Ontario | Canada | -79.56985 | 43.64415 Hamilton | Ontario | Canada | -79.84963 | 43.25011 London | Ontario | Canada | -81.23304 | 42.98339 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Sarnia | Ontario | Canada | -82.40407 | 42.97866 Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139 Birkerød | N/A | Denmark | 12.42791 | 55.84759 Haderslev | N/A | Denmark | 9.48771 | 55.24943 Herning | N/A | Denmark | 8.97662 | 56.13615 Hinnerup | N/A | Denmark | 9.05874 | 56.7347 Rødovre Municipality | N/A | Denmark | 12.45373 | 55.68062 Rødovre Municipality | N/A | Denmark | 12.45373 | 55.68062 Vaerløse | N/A | Denmark | N/A | N/A Vildbjerg | N/A | Denmark | 8.76667 | 56.2 Joensuu | N/A | Finland | 29.76316 | 62.60118 Joensuu | N/A | Finland | 29.76316 | 62.60118 Turku | N/A | Finland | 22.26869 | 60.45148 Turku | N/A | Finland | 22.26869 | 60.45148 Aigrefeuille S/Maine | N/A | France | N/A | N/A Angers | N/A | France | -0.55202 | 47.47156 Angers | N/A | France | -0.55202 | 47.47156 Angers | N/A | France | -0.55202 | 47.47156 Angers | N/A | France | -0.55202 | 47.47156 Avrillé | N/A | France | -0.58955 | 47.50663 Beaucouzé | N/A | France | -0.63219 | 47.47514 Bourg Des Cptes | N/A | France | N/A | N/A Briollay | N/A | France | -0.50805 | 47.56446 Cholet | N/A | France | -0.87974 | 47.05893 Cholet | N/A | France | -0.87974 | 47.05893 Garchizy | N/A | France | 3.09625 | 47.04786 Grandchamps | N/A | France | N/A | N/A Guérigny | N/A | France | 3.20182 | 47.08703 Jarny | N/A | France | 5.8764 | 49.15873 La Chapelle /s Erdre | N/A | France | N/A | N/A La Chapelle-sur-Erdre | N/A | France | -1.55239 | 47.29964 La Fresnais | N/A | France | -1.84333 | 48.59555 La Jubaudière | N/A | France | -0.89215 | 47.17202 La Montagne | N/A | France | -1.68395 | 47.18987 Le Mesnil-en-Vallée | N/A | France | -0.93485 | 47.36551 Le Temple-de-Bretagne | N/A | France | -1.79143 | 47.32868 Les Ponts-de-Cé | N/A | France | -0.52477 | 47.42315 Louvigné Le Bais | N/A | France | N/A | N/A Mouliherne | N/A | France | 0.01586 | 47.46657 Mûrs-Erigné | N/A | France | -0.55293 | 47.39592 Mûrs-Erigné | N/A | France | -0.55293 | 47.39592 Nantes | N/A | France | -1.55336 | 47.21725 Nantes | N/A | France | -1.55336 | 47.21725 Nantes | N/A | France | -1.55336 | 47.21725 Nantes | N/A | France | -1.55336 | 47.21725 Nevers | N/A | France | 3.159 | 46.98956 Nevers | N/A | France | 3.159 | 46.98956 Nort-sur-Erdre | N/A | France | -1.49909 | 47.4399 Orvault | N/A | France | -1.62361 | 47.27117 Parçay-les-Pins | N/A | France | 0.16312 | 47.43668 Saint Aubin Les Châteaux | N/A | France | N/A | N/A Saint-Georges-de-Montaigu | N/A | France | -1.29262 | 46.94655 Saint-Ouen-la-Rouërie | N/A | France | -1.44093 | 48.46234 Sautron | N/A | France | -1.67222 | 47.26345 Segré | N/A | France | -0.87268 | 47.68672 Thouars | N/A | France | -0.21175 | 46.9815 Tinténiac | N/A | France | -1.83545 | 48.32908 Vihiers | N/A | France | -0.5346 | 47.1458 Beerzerveld | N/A | Netherlands | 6.57361 | 52.49333 Bennebroek | N/A | Netherlands | 4.59861 | 52.32083 Hoogwoud | N/A | Netherlands | 4.93889 | 52.71583 Musselkanaal | N/A | Netherlands | 7.01528 | 52.9325 Nijverdal | N/A | Netherlands | 6.46806 | 52.36 Oude Pekela | N/A | Netherlands | 7.00972 | 53.10417 Roelofarendsveen | N/A | Netherlands | 4.63333 | 52.20333 Voerendaal | N/A | Netherlands | 5.92978 | 50.88327 Ålesund | N/A | Norway | 6.15492 | 62.47225 Bergen | N/A | Norway | 5.32415 | 60.39299 Hamar | N/A | Norway | 11.06798 | 60.7945 Oslo | N/A | Norway | 10.74609 | 59.91273 Makati City | N/A | Philippines | 121.03269 | 14.55027 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Pasay | N/A | Philippines | 121.00144 | 14.53748 Pasig | N/A | Philippines | 121.0614 | 14.58691 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Boksburg | N/A | South Africa | 28.25958 | -26.21197 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Durban | N/A | South Africa | 31.0292 | -29.8579 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Krugersdorp | N/A | South Africa | 27.77515 | -26.08577 Lenasia | N/A | South Africa | 27.83564 | -26.32052 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Busan | N/A | South Korea | 129.03004 | 35.10168 Daegu | N/A | South Korea | 128.59111 | 35.87028 Daejeon | N/A | South Korea | 127.38493 | 36.34913 Gangwon-Do | N/A | South Korea | N/A | N/A Gwangju | N/A | South Korea | 126.91556 | 35.15472 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Luleå | N/A | Sweden | 22.15465 | 65.58415 Rättvik | N/A | Sweden | 15.11787 | 60.88632 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Changhua | N/A | Taiwan | 120.5512 | 24.0692 Hualien City | N/A | Taiwan | 121.60444 | 23.97694 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Taichung | N/A | Taiwan | 120.6839 | 24.1469

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 study is to investigate whether the source of low level plasma virus is from latent (old) infection or ongoing (new) infection. MK-0518 is a investigational drug, which means that is not yet FDA approved, that works in a different way to other anti-HIV medicines to help kill the virus. We hypothesize that addition of MK-0518 to a stable anti-HIV regimen will reduce the viral load further in patients with undetectable plasma virus.

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 12 hours for 28 days in addition to their prescribed antiretroviral therapy. Patients will take their doses of MK-0518 without regard to food. The study will enroll patients on antiretroviral therapy regimens with Cluster of Differentiation 4 (CD4) counts greater than 200 cells/ul, HIV-1 RNA levels \<50 copies RNA/ml plasma using a commercial assay(conventional Amplicor) and with detectable plasma virus (viral loads ≥ 1 copies RNA/ml plasma, Single copy assay, "SCA"). Acceptable antiretroviral regimens will include those on Nucleoside reverse transcriptase inhibitors ("NRTIs") + protease inhibitor (PI)I, NRTIs + non-nucleoside reverse transcriptase inhibitors (NNRTIs), + PI, or NRTIs + NNRTI-containing regimens. Patients cannot have prior evidence of resistance to antiretroviral drugs. Patients will be screened for intensification by history, physical exam, and laboratory evaluations (see below). Patients who are eligible and who agree to participate will intensify their antiretroviral therapy for 28 days with MK-0518 400 mg by mouth twice a day. During the 28- day drug addition, patients will have samples drawn for SCA assay at entry and on days 7, 14, 21, and 28 (+/- 1 d), with the last day of intensification as day 28. Patients will have additional phlebotomy after intensification on days 29, 30, 35, 42, 49 and 58 (+/- 1 day). The intensification period is followed by a post- intensification period to determine whether removal of the drug resulted in viral RNA changes.

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 morning dose on the third day. intervention 2: Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo 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 morning dose on the third day.

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 prednisolone will shrink the size of lipomas, which are benign fatty tumors.

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 their fat. The fat cells become resistant to isoproterenol with repeated use. Prednisolone, a synthetic cortisone medication used to treat immune problems like allergy and approved for injection under the skin, keeps the fat cells from becoming resistant to isoproterenol. It is not known, if the fat cells in lipomas act like other fat cells or if the combination of isoproterenol and prednisolone injections would shrink lipomas without surgery. This study is designed to test this possibility. Subjects will have a screening visit, 2 microdialysis visits a week apart, 20 treatment visits 5 days per week for 4 weeks, and up to 12 follow-up visits a year after treatment visits. During screening, subjects will have a history, physical exam, blood testing, electrocardiogram and a pregnancy testing if female with reproductive capacity. The first microdialysis visit will consist of placing two microdialysis catheters under the skin after the area is numbed. One microdialysis catheter will be in the lipoma and the other under the skin 2 inches away. The microdialysis catheter will connect to a pump, isoproterenol will be infused and the amount of fat breakdown measured. One week later prednisolone will be injected into the lipoma and under the skin 2 inches away. The microdialysis visit will be repeated 24 hours later. Treatment will consist of injecting the lipoma 5 days a week with a mixture of isoproterenol and prednisolone in the Pennington clinic as a diabetic would inject insulin. Each week the blood pressure, pulse and lipoma will be measured and subjects will be asked how they feel. At the end of the treatment period the physical examination, blood test and electrocardiogram will be repeated. The insertion of the microdialysis probes under the skin into the fat tissue could be uncomfortable, but numbing medication will be injected first to prevent this problem. At higher doses, isoproterenol could lower blood pressure and increase pulse rate. This should not happen at the doses used, but blood pressure and pulse will be monitored throughout the study. Prednisolone, at higher doses, could decrease the body's production of cortisone. This should not happen at the doses being used, but cortisone in the body will be measured during the trial. Blood tests involve the discomfort of a needle going through the skin of the arm, possible bruising and rarely fainting or infection. Trained technicians and sterile needles will minimize these risks.

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

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 Expectancy: at least 12 weeks Hematopoietic: * Platelets \> 100 K/mm3 * Absolute neutrophil count (ANC) \> 1.5 K/mm3 * Hemoglobin \> 10 g/dL Hepatic: * Total Bilirubin \< 1.5 x ULN * Aspartate aminotransferase (AST, SGOT) \< 2 x ULN (up to 5 x ULN in patients with known liver involvement) Renal: * Creatinine \< 1.5 x ULN * No proteinuria as demonstrated by either Urine protein:creatinine (UPC) ratio \< 1.0 or Urine dipstick for proteinuria \< 2+ Cardiovascular: * No known myocardial infarction, unstable angina, \> grade II New York Heart Association (NYHA) classification, congestive heart failure, uncontrolled hypertension defined as SBP \>150 or DBP \>100, \> grade II peripheral vascular disease or significant vascular disease (e.g. aortic aneurysm, aortic dissection) within 12 months prior to being registered for protocol therapy. * No uncontrolled or clinically significant arrhythmia. NOTE: Controlled atrial fibrillation is allowed. * LVEF ≥ LLN by MUGA or ECHO as obtained within 28 days prior to being registered for protocol therapy. Pulmonary: * No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within 28 days prior to being registered for protocol therapy.

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

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 metronidazole cream on the right side of the face and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily). The corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated participants will only receive twice daily treatment with metronidazole cream if and when they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The anticipated time on metronidazole treatment is less than (\<) 3 months, and the target sample size is \<100 individuals.

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 according to local standard procedures (ie, with non-active moisturizing cream). arm 2: Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated when participants develop rash. 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 was treated according to local standard procedures (ie, with non-active moisturizing cream).

[ 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 (ie, with non-active moisturizing cream).

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 treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

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, for first 9 cycles intervention 5: 135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

intervention 1: capecitabine [Xeloda] intervention 2: capecitabine [Xeloda] intervention 3: bevacizumab [Avastin] intervention 4: oxaliplatin intervention 5: irinotecan

76

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 tremor. Parkinson's Disease , however, reveals numerous non-motor symptoms that have been underemphasized. Problematic symptoms include varying degrees of dementia, psychosis, diminished assertiveness and confidence, general fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder, and a common yet difficult to define sense of "not feeling well".

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) score of greater or equal to 2. Patients with dementia (MMSE\<24) or taking amantadine were excluded. The patients signed an informed consent approved by the Baylor College of Medicine Institutional Review Board and the study was registered on Clinical Trials.gov #NCT00646204. The study was funded by a grant from the Forest Research Institute. After baseline assessments, patients (N=40) were randomized equally to drug (N=20) and placebo (N=20) groups. This was done by a computerized random number generator by a coordinator not otherwise involved in the study. Patients completed medical and medication histories, a Unified Parkinson's Disease Rating Scale (UPDRS), a battery of neuropsychiatric assessments (see Table 2), global impressions, and adverse events. Patients were not allowed to change other PD medications. The drug/placebo dosing began at 5 mg/day and increased to 5 mg 2x/day, 10 mg / 5 mg, and finally 10 mg 2x/day, in weekly increments. After a safety call (2 weeks after initiation) they returned for identical assessments at week 8. Drug accountability was documented at each visit. An 8-week open label extension was started if desired using the same protocol and assessments. Tabulations and univariate statistics on difference scores between visits were run using Intercooled Stata V8.0 for windows (Stata Corporation, College Station, Texas 77845), and included Student's t-test with equal variances and contingency table analysis using Pearson's Chi-square test. Statistics were done using LOCF. Corrections for multiple comparisons were not done.

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 adenocarcinoma. Due to its manageable toxicity profile, ease of administration, and activity in both platinum sensitive as well as platinum-resistant patients, Doxil has become the 2nd-line treatment of choice for women with advanced stage ovarian cancer that has progressed following 1st-line platinum/taxane therapy. PURPOSE: To determine if a treatment combination of atrasentan + Doxil is an effective 2nd line treatment in patients with recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer.

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 survival of patients treated with this regimen. * To determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with platinum-taxane (sensitive vs resistant). Patients will be administered Doxil 50 mg/m2 intravenous every 28 days and take atrasentan 10 mg orally everyday continuously beginning on Day 1. Patients will continue Doxil + atrasentan in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days and every 2 months thereafter.

Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer

recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer

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arm 1: None

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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

0

NCT00653328