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

[ 5 ]

80

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

1FEMALE

false

Prospective open label, randomised, parallel group, comparative pilot.

Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of pronuclear stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos, endometrial thickness and morphology on day of HCG administration, estradiol levels at day of HCG administration, implantation rate, number of days stimulated with gonadotrophins and number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive pregnancy test, pregnancy outcome.

Infertility

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily. intervention 2: 150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.

intervention 1: Menotrophin intervention 2: Follitropin alfa

6

Dortmund | N/A | Germany | 7.466 | 51.51494 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Hildesheim | N/A | Germany | 9.95112 | 52.15077 Edinburgh | N/A | United Kingdom | -3.19648 | 55.95206 Leeds | N/A | United Kingdom | -1.54785 | 53.79648 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297

0

NCT00257556

[ 4 ]

360

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

null

Non-Hodgkin's Lymphoma

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 375mg/m2 iv monthly for 8 cycles intervention 2: As prescribed

intervention 1: rituximab [MabThera/Rituxan] intervention 2: Standard chemotherapy

33

Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Bonn | N/A | Germany | 7.09549 | 50.73438 Borna | N/A | Germany | 12.49639 | 51.12416 Chemnitz | N/A | Germany | 12.92922 | 50.8357 Cottbus | N/A | Germany | 14.32888 | 51.75769 Dresden | N/A | Germany | 13.73832 | 51.05089 Dresden | N/A | Germany | 13.73832 | 51.05089 Dülmen | N/A | Germany | 7.28075 | 51.83149 Erfurt | N/A | Germany | 11.03283 | 50.9787 Frankfurt (Oder) | N/A | Germany | 14.55062 | 52.34714 Greifswald | N/A | Germany | 13.40244 | 54.08905 Güstrow | N/A | Germany | 12.17337 | 53.7972 Halle | N/A | Germany | 11.97947 | 51.48158 Halle | N/A | Germany | 11.97947 | 51.48158 Jena | N/A | Germany | 11.5899 | 50.92878 Jena | N/A | Germany | 11.5899 | 50.92878 Leipzig | N/A | Germany | 12.37129 | 51.33962 Leipzig | N/A | Germany | 12.37129 | 51.33962 Magdeburg | N/A | Germany | 11.62916 | 52.12773 Magdeburg | N/A | Germany | 11.62916 | 52.12773 Marburg | N/A | Germany | 8.77069 | 50.80904 Neubrandenburg | N/A | Germany | 13.27532 | 53.56414 Nordhausen | N/A | Germany | 10.7957 | 51.5018 Potsdam | N/A | Germany | 13.06566 | 52.39886 Riesa | N/A | Germany | 13.29168 | 51.30777 Rostock | N/A | Germany | 12.14049 | 54.0887 Rostock | N/A | Germany | 12.14049 | 54.0887 Schwerin | N/A | Germany | 11.41316 | 53.62937 Stralsund | N/A | Germany | 13.0818 | 54.30911 Trier | N/A | Germany | 6.63935 | 49.75565 Zella-Mehlis | N/A | Germany | 10.66046 | 50.65642

0

NCT00269113

[ 3 ]

10

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving whole-brain radiation therapy together with pemetrexed works in treating patients with brain metastases from non-small cell lung cancer.

OBJECTIVES: Primary * Estimate the response in patients with intracranial brain metastases from non-small cell lung cancer treated with whole-brain radiotherapy and pemetrexed disodium. Secondary * Determine the toxicity of this regimen in these patients. * Estimate the overall survival of patients treated with this regimen. * Evaluate the functional status of patients treated with this regimen. * Assess neurological function and progression in patients treated with this regimen. * Determine the response of patients with extracranial disease treated with pemetrexed disodium. OUTLINE: Patients undergo whole-brain radiotherapy 5 days a week for 3 weeks beginning on day 1. Patients also receive pemetrexed disodium IV on day 1, 2, or 3 and day 28 of course 1, and on day 1 of each subsequent course. Treatment with pemetrexed disodium repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days and then every 2 months for 2 years.

Lung Cancer Metastatic Cancer

recurrent non-small cell lung cancer stage IV non-small cell lung cancer tumors metastatic to brain

null

1

arm 1: Single Arm Study

[ 5 ]

2

[ 0, 4 ]

intervention 1: 500 mg/m2 once every 21 days up to 126 days intervention 2: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy

intervention 1: pemetrexed disodium intervention 2: radiation therapy

2

0

NCT00280748

[ 4 ]

504

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.

null

Smoking Cessation

smoking cessation smoking cessation in COPD

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: 1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days) intervention 2: 1 mg by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)

intervention 1: placebo intervention 2: Varenicline Tartarate

32

0

NCT00285012

[ 0 ]

11

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to see whether the medication mifepristone is an effective and tolerable treatment for increasing the clinical effectiveness of electroconvulsive therapy (ECT) and protecting cognitive function during ECT. Both Mifepristone and ECT appear to normalize hyperfunctioning of the hypothalmic-pituitary-adrenal (HPA) axis, which has been found among patients with major depression referred for ECT. The combination of these two treatments in major depression may lead to a more rapid clinical response than ECT alone. Additionally, there appears to be a connection between pre-ECT higher cortisol levels due to HPA axis hyperfunctioning and post-ECT cognitive impairment. Administration of mifepristone prior to and during ECT treatment may reduce cortisol levels and reduce the incidence of cognitive impairment observed after ECT.

Patients referred to the Stanford ECT Service who provide informed consent for this study will be screened for eligibility. Day -4 to 0: Screening (visit 1) will occur three to six days prior to the first ECT treatment. Screening procedures will include: Psychiatric interviews and ratings (including MINI, Hamilton Depression Rating Scale and Clinician's Global Impression) and review/retrieval of results of pre-ECT physical exam, ECG, chest x-ray, laboratory evaluations (including comprehensive metabolic panel, comprehensive blood count, and urine toxicology), and vital signs from the subject's medical record. A urine pregnancy test will be included for females of childbearing potential. Concomitant medications and pre-existing health issues will be recorded. Subjects who are deemed eligible for this study will then undergo a battery of neuropsychiatric assessments and will be admitted to GCRC for collection of blood samples to measure adrenocorticotropin (ACTH) and cortisol levels. These samples will be collected hourly beginning at 1pm and ending at 4pm. Day 1: Subjects will be randomized 1:1 to receive either mifepristone 600mg or placebo each day at bedtime beginning two days prior to the first ECT treatment. Subjects will be administered study medication on Day 1 through Day 8. Day 3: Subjects will be interviewed with the Hamilton Depression Rating Scale and Clinician's Global Impression before their first ECT treatment. Day 11: (visit 2) assessments will include psychiatric ratings (including Hamilton Depression Rating Scale and Clinician's Global Impression) and a battery of neuropsychiatric assessments. Adverse events and concomitant medications will be reviewed and recorded. Subjects will be admitted to the GCRC for collection of blood samples to measure ACTH and cortisol levels. Samples will be collected hourly beginning at 1pm and ending at 4pm. Day 18: (visit 3) assessments will include psychiatric ratings (including Hamilton Depression Rating Scale and Clinician's Global Impression). Adverse events and concomitant medications will be reviewed and recorded. Clinical laboratory assessments will be completed (including a urine pregnancy test for females, comprehensive metabolic panel, comprehensive blood count, urine toxicology, and ECG.) Final visit: (visit 4) will occur 24-72 hours after the last ECT treatment. Assessments will include psychiatric ratings (including Hamilton Depression Rating Scale and Clinician's Global Impression) and a battery of neuropsychiatric assessments. Adverse events and concomitant medications will be reviewed and recorded. A urine pregnancy test will be completed for females. In addition to the ECT treatment consent, the following materials will be collected from the participant's medical record for every ECT treatment: ECT treatment orders, ECT procedure note and the results of each pre-ECT Montgomery-Asberg Depression Rating Scale (MADRS). ECT treatments at Stanford's ECT Service run every Monday, Wednesday and Friday.

Depression

null

2

arm 1: Patients receive mifepristone one day before and for 5 additional days after starting ECT arm 2: Patients receive a placebo capsule one day before and for 5 additional days after starting ECT

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Mifepristone is a glucocorticoid receptor antagonist. intervention 2: Placebo is a capsule without a pharmacological active ingredient

intervention 1: Mifepristone intervention 2: Placebo Oral Capsule

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00285818

[ 5 ]

4

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

false

The purpose of the study is to evaluate the safety and efficacy of two dose levels of Naglazyme in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth.

The primary objective of the study was to evaluate the efficacy of two dose levels of Naglazyme in preventing the progression of skeletal dysplasia in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth. The secondary objective of the study was to evaluate the efficacy of the two dose levels of Naglazyme in preventing several measures of disease progression in infants under the age of one year who have MPS VI by monitoring urinary GAGs, gross and fine motor function, cardiac function, vision, hearing, and use of health resources. The safety objective of the study was to evaluate the safety of two dose levels of Naglazyme in infants under the age of one year who have MPS VI.

Mucopolysaccharidosis VI Maroteaux-Lamy Syndrome

null

2

arm 1: Dose comparison arm 2: Dose Comparison

[ 5, 5 ]

1

[ 0 ]

intervention 1: Weekly infusion for minimum of 52 weeks. Naglazyme is diluted in sterile 0.9% sodium chloride solution

intervention 1: Naglazyme

4

Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Lyon | N/A | France | 4.84671 | 45.74846 Coimbra | N/A | Portugal | -8.41955 | 40.20564

0

NCT00299000

[ 5 ]

100

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

2MALE

false

We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant. During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatment-refractory depression and low or borderline low testosterone levels will be treated with either AndroGel or placebo. Following this nine week, double-blind phase, eligible subjects will have the option to continue into a six month, open-label phase during which time all subjects will receive the AndroGel patch.

We will recruit 100 men between the ages of 30 and 65 years who have treatment-refractory depression and low or borderline low testosterone levels for participation in this study. For a period of nine weeks subjects will receive double-blind treatment with either AndroGel (testosterone gel) or placebo. During this double-blind treatment phase subjects will come to McLean Hospital for a total of seven visits. Both clinical assessments (including ratings of your levels of depression and anxiety, quality of life, and visuospatial memory)and laboratory tests will be performed at these visits. Following the nine week, double-blind phase, eligible subjects may enter into a six month, open-label treatment phase in which all subject receive AndroGel. If you participate in the open-label phase, you will be asked to return to the site for 8 visits during the six month period.

Depressive Disorder, Major

null

2

arm 1: AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily arm 2: Placebo gel

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial. intervention 2: Placebo

intervention 1: Testosterone gel intervention 2: Placebo

2

Belmont | Massachusetts | United States | -71.17867 | 42.39593 Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096

0

NCT00304746

[ 4 ]

92

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Asthma can be caused by a variety of factors, including tobacco smoke, allergens, and respiratory airway infections. Many people use inhaled corticosteroid medications to treat their symptoms. These medications, however, are not effective for everyone. Clarithromycin is an antibiotic that may effectively treat asthma in these individuals. This study will evaluate the effectiveness of clarithromycin at controlling asthma symptoms.

Asthma prevalence has steadily increased in the United States since the early 1980s; currently, more than 20 million people are diagnosed with asthma. Individuals with this disease may experience periodic attacks of wheezing, shortness of breath, chest tightness, and coughing. While there are many known causes of asthma, including tobacco smoke and other allergens, the exact cause of some asthma cases remains unknown. Research has shown that in some individuals, respiratory airway infections may play a role in the onset and severity of the disease. Inhaled corticosteroids are commonly used to treat asthma; however, they do not effectively control symptoms for everyone. Clarithromycin, an antibiotic medication used to treat bacterial infections, may be an effective asthma treatment for individuals who do not respond well to inhaled corticosteroids. The purpose of this study is to evaluate the effectiveness of clarithromycin at reducing asthma symptoms. This study will begin with a 4-week run-in period to standardize participants' asthma medication usage. During this time, all participants will stop their current asthma medications and instead will receive inhaled fluticasone twice a day. Albuterol will be available as a rescue medication if necessary. Study visits will take place every 2 weeks. Blood and saliva samples will be obtained for laboratory tests and participants will complete standardized questionnaires to assess asthma symptoms and quality of life. Spirometry will be performed to measure lung function. Medication adherence will be monitored with a daily diary and an electronic pill counting device. At the end of Week 4, participants will be evaluated for study eligibility. If eligible, participants will undergo a bronchoscopy and a lung biopsy to test for Mycoplasma pneumoniae and Chlamydia pneumoniae, two bacteria that have been identified as possible factors in the development of asthma. The treatment phase of the study will last 16 weeks. Participants will be randomly assigned to receive either 500 mg of clarithromycin or placebo twice a day, plus inhaled fluticasone. At monthly study visits, spirometry and blood collection will be performed. Standardized questionnaires to assess asthma symptoms will be completed every 2 weeks. Medical adherence will continue to be monitored. At the end of Week 16, participants will stop receiving clarithromycin or placebo, but will continue to receive fluticasone. Asthma symptoms, rescue medication usage, quality of life, and lung capacity will be assessed; tissue samples will be examined for the presence of Mycoplasma pneumoniae and Chlamydia pneumoniae. An 8-week washout period will follow to observe any lingering medication effects and to monitor for safety. Monthly study visits during this period will include spirometry and blood collection.

Asthma

null

2

arm 1: clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily) arm 2: placebo clarithromycin twice daily + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: clarithromycin 500 mg twice daily (Biaxin) intervention 2: fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily) intervention 3: placebo clarithromycin twice daily

intervention 1: clarithromycin intervention 2: fluticasone propionate intervention 3: placebo clarithromycin

10

0

NCT00318708

[ 4 ]

151

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

null

Pulmonary Hypertension

pulmonary hypertension bosentan BENEFIT CTEPH inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

null

1

arm 1: Open label bosentan treatment

[ 0 ]

1

[ 0 ]

intervention 1: Oral bosentan * Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients * Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight \< 40 kg)

intervention 1: bosentan

0

null

0

NCT00319111

[ 3 ]

62

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with the data from EGF100642 and integrated analysis will be carried out in order to enhance the credibility of the study results.

null

Neoplasms, Breast

Stage IV breast cancer Herceptin metastatic breast cancer ErbB1 ErbB2 trastuzumab lapatinib

null

1

arm 1: Lapatinib 1500mg QD

[ 0 ]

1

[ 0 ]

intervention 1: Lapatinib 1500mg QD

intervention 1: lapatinib

9

Ehime | N/A | Japan | N/A | N/A Fukuoka | N/A | Japan | 130.41667 | 33.6 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Okayama | N/A | Japan | 133.93333 | 34.65 Tochigi | N/A | Japan | 139.73333 | 36.38333 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 N/A | N/A | N/A | N/A | N/A

0

NCT00320411

[ 5 ]

535

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

null

Parkinson Disease

null

2

arm 1: Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day). arm 2: Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).

[ 0, 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: pramipexole

99

Brimingham | Alabama | United States | N/A | N/A Scottsdale | Arizona | United States | -111.89903 | 33.50921 La Jolla | California | United States | -117.2742 | 32.84727 La Jolla | California | United States | -117.2742 | 32.84727 New Haven | Connecticut | United States | -72.92816 | 41.30815 Bradenton | Florida | United States | -82.57482 | 27.49893 Gainesville | Florida | United States | -82.32483 | 29.65163 Hollywood | Florida | United States | -80.14949 | 26.0112 Palm Beach Gardens | Florida | United States | -80.13865 | 26.82339 Panama City | Florida | United States | -85.65983 | 30.15946 South Miami | Florida | United States | -80.29338 | 25.7076 St. Petersburg | Florida | United States | -82.67927 | 27.77086 Tampa | Florida | United States | -82.45843 | 27.94752 Atlanta | Georgia | United States | -84.38798 | 33.749 Augusta | Georgia | United States | -81.97484 | 33.47097 Columbus | Georgia | United States | -84.98771 | 32.46098 Chicago | Illinois | United States | -87.65005 | 41.85003 Elk Grove Village | Illinois | United States | -87.97035 | 42.00392 Scarbourough | Maine | United States | N/A | N/A Baltimore | Maryland | United States | -76.61219 | 39.29038 Worcester | Massachusetts | United States | -71.80229 | 42.26259 Traverse City | Michigan | United States | -85.62063 | 44.76306 New York | New York | United States | -74.00597 | 40.71427 Raleigh | North Carolina | United States | -78.63861 | 35.7721 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Cleveland | Ohio | United States | -81.69541 | 41.4995 Dayton | Ohio | United States | -84.19161 | 39.75895 Tulsa | Oklahoma | United States | -95.99277 | 36.15398 Warwick | Rhode Island | United States | -71.41617 | 41.7001 Memphis | Tennessee | United States | -90.04898 | 35.14953 Houston | Texas | United States | -95.36327 | 29.76328 Kirkland | Washington | United States | -122.20874 | 47.68149 Bruck A. D. Mur | N/A | Austria | N/A | N/A Graz | N/A | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Helsinki | N/A | Finland | 24.93545 | 60.16952 Lahti | N/A | Finland | 25.66151 | 60.98267 Oulu | N/A | Finland | 25.46816 | 65.01236 Aix-en-Provence | N/A | France | 5.44973 | 43.5283 Aix-en-Provence | N/A | France | 5.44973 | 43.5283 Aix-en-Provence | N/A | France | 5.44973 | 43.5283 Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 Évreux | N/A | France | 1.15082 | 49.02414 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 Toulouse | N/A | France | 1.44367 | 43.60426 Toulouse | N/A | France | 1.44367 | 43.60426 Augsburg | N/A | Germany | 10.89851 | 48.37154 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Bonn | N/A | Germany | 7.09549 | 50.73438 Gera | N/A | Germany | 12.08187 | 50.88029 Göttingen | N/A | Germany | 9.93228 | 51.53443 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanau | N/A | Germany | 8.91418 | 50.13423 Hanover | N/A | Germany | 9.73322 | 52.37052 Leipzig | N/A | Germany | 12.37129 | 51.33962 Marburg | N/A | Germany | 8.77069 | 50.80904 München | N/A | Germany | 13.31243 | 51.60698 Tübingen | N/A | Germany | 9.05222 | 48.52266 Bari | N/A | Italy | 16.86982 | 41.12066 Bologna | N/A | Italy | 11.33875 | 44.49381 Grosseto | N/A | Italy | 11.10941 | 42.76296 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Napoli | N/A | Italy | 14.5195 | 40.87618 Pisa | N/A | Italy | 10.4036 | 43.70853 Roma | N/A | Italy | 11.10642 | 44.99364 Torino | N/A | Italy | 11.99138 | 44.88856 Torino | N/A | Italy | 11.99138 | 44.88856 Venezia Mestre | N/A | Italy | N/A | N/A Viareggio | N/A | Italy | 10.2502 | 43.86693 Bunkyo-ku, Tokyo | N/A | Japan | N/A | N/A Takamatsu, Kagawa | N/A | Japan | N/A | N/A Alcorcon (Madrid) | N/A | Spain | -3.82487 | 40.34582 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Tarrasa (Barcelona) | N/A | Spain | N/A | N/A Jönköping | N/A | Sweden | 14.15618 | 57.78145 Linköping | N/A | Sweden | 15.62157 | 58.41086 Norrköping | N/A | Sweden | 16.1826 | 58.59419 Örebro | N/A | Sweden | 15.2066 | 59.27412 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 London | N/A | United Kingdom | -0.12574 | 51.50853 Newark | N/A | United Kingdom | -0.21222 | 52.59519 Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328 North Shields | N/A | United Kingdom | -1.44925 | 55.01646 Romford | N/A | United Kingdom | 0.18582 | 51.57515 Stoke-on-Trent | N/A | United Kingdom | -2.18538 | 53.00415

0

NCT00321854

[ 3 ]

305

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

null

This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed from person to person during sex. This study will compare the 2 currently recommended NGU treatments, doxycycline and azithromycin, taken with tinidazole (another medication to treat certain sexually transmitted infections). Tinidazole used with doxycycline or azithromycin may cure NGU better than when doxycycline or azithromycin is used alone. Study participants will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Study participation will last 7 weeks and involve 3 visits. At each visit, participants will provide a urine sample, have 2 urethral swabs, and have their urethra checked for discharge indicating infection.

This study represents a clinical evaluation of the use of combination therapy for the initial treatment of non-gonococcal urethritis (NGU). This study will provide more current data on the comparison of cure rates between the 2 currently recommended therapies for NGU, doxycycline and azithromycin. Emerging clinical data has suggested that the latter may have become more efficacious for NGU as it is more effective in eradicating Mycoplasma (M.) genitalium from the genital tract than the former. Only in vitro data, limited as it is, suggests that doxycycline should be active against M. genitalium. The researchers hypothesize that cure rates for NGU will be significantly improved for both doxycycline and azithromycin using combination therapy with tinidazole. Important safety and tolerability data will be collected with regards to the use of combination therapy. Additionally, the study will provide data on the prevalence of the targeted pathogens in 4 geographic areas and on characteristics of men with NGU that may help to target populations who would benefit the most from combination therapy. The researchers hypothesize that currently recommended initial therapies for NGU are inadequate in at least certain populations due to lack of coverage for Trichomonas (T.) vaginalis. The researchers further hypothesize that between the 2 currently recommended regimens, azithromycin will result in a greater number of cures than doxycycline due to its greater efficacy in M. genitalium infected men. The primary study objectives are to: compare the clinical cure rates of doxycycline versus doxycycline with tinidazole; and azithromycin versus azithromycin with tinidazole for the treatment of NGU; and to evaluate the safety and tolerability of doxycycline/tinidazole and azithromycin/tinidazole in the treatment of NGU. Secondary study objectives are to: evaluate microbiological cure of Chlamydia (C.) trachomatis, T. vaginalis, M. genitalium in men treated with doxycycline versus doxycycline with tinidazole; and azithromycin versus azithromycin with tinidazole. Analysis will also include: (doxycycline plus doxycycline/tinidazole) versus (azithromycin plus azithromycin/tinidazole); for the clinical cure rates, analysis will also include: (doxycycline plus doxycycline/tinidazole) versus (azithromycin plus azithromycin/tinidazole); determine the prevalence of C. trachomatis, T. vaginalis, and M. genitalium in the study population of men with non-gonococcal urethritis; determine clinical, behavioral, and demographic predictors of the above organisms in men with non-gonococcal urethritis; and collect specimens for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis. Outcome measures include clinical failure, clinical cure, microbiological cure, and unevaluable cure assessed at the first and second follow-up visits. Study participants will include 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Subjects will be randomly assigned to 1 of 4 active treatment arms: 75 subjects doxycycline; 75 subjects doxycycline plus tinidazole; 75 subjects azithromycin; and 75 subjects azithromycin plus tinidazole.

Urethritis

non-gonococcal urethritis, doxycycline, azithromycin, sexually transmitted, tinidazole

null

4

arm 1: Doxycycline 100 mg orally twice daily (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin orally single dose and placebo tinidazole. arm 2: Doxycycline 100 mg orally twice daily for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm orally single dose (4 tablets at 500 mg each). arm 3: Azithromycin 1 gram (gm) orally single dose (2 tablets at 500 milligrams (mg) each) plus doxycycline placebo twice daily for 7 days plus tinidazole placebo single dose. arm 4: Azithromycin 1 gm orally single dose (2 tablets at 500 mg each) plus doxycycline placebo twice daily for 7 days plus tinidazole single dose (4 tablets at 500 mg each).

[ 0, 0, 0, 0 ]

4

[ 0, 10, 0, 0 ]

intervention 1: 2 gm single dose (4 tablets orally at 500 mg each). intervention 2: Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline. intervention 3: 100 mg orally, twice daily for 7 days. intervention 4: 1 gram (gm) (2 tablets orally at 500 milligrams (mg) each).

intervention 1: Tinidazole intervention 2: Placebo intervention 3: Doxycycline intervention 4: Azithromycin

4

0

NCT00322465

[ 3 ]

8

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Background: * Natural killer (NK) cells are large lymphocytes (a type of white blood cell) that are important in the immune response to cancer. * IL-2 (Aldesleukin) is a substance the body makes that controls the growth and function of many types of cells. The Food and Drug Administration has approved IL-3 for treating metastatic melanoma and kidney cancer. (Metastatic disease is cancer that has spread beyond the primary site.) Objectives: To determine the safety and effectiveness of treating metastatic melanoma and kidney cancer with laboratory-treated NK cells and IL-2. Eligibility: Patients 18 years of age or older with metastatic melanoma or kidney cancer who have previously been treated with high-dose IL-2. Design: * Leukapheresis. Patients under leukapheresis to obtain NK cells for the treatment regimen. Blood is collected through a needle in an arm vein and directed through a cell separator machine where white blood cells are extracted. The rest of the blood is returned to the patient through a needle in the other arm. NK cells are removed from the white blood cells and treated for re-infusion into the patient. * Chemotherapy. Starting 8 days before infusion of the treated NK cells, patients receive intravenous (IV, through a vein) infusions of cyclophosphamide and fludarabine to suppress the immune system. * NK cell infusion. Patients receive a 30-minute IV infusion of NK cells 2 days after the last dose of chemotherapy. * IL-2 therapy. Within 24 hours of the NK cell infusion, patients receive high-dose IL-2 as a 15-minute IV infusion every 8 hours for up to 5 days. A second cycle of IL-2 is given about 14 days after the first. * Blood tests and biopsy. Patients have frequent blood tests during the treatment period and may be asked to undergo a biopsy (surgical removal of a small piece of tumor or lymph node) at the end of treatment to look at the effects of the treatment on the tumor immune cells. * Follow-up evaluation. Patients are evaluated 4-6 weeks after completing treatment. They have a physical examination, scans of tumor sites, blood tests and blood sampling (or leukapheresis) to examine the response to treatment. Patients who improve with treatment return for evaluations every month. Those whose tumor grows again after originally shrinking may receive one additional treatment course.

Background: * Natural killer (NK) cells are large granular lymphocytes that are critical effector cells in the early innate immune response to pathogens and cancer. * Previous and current clinical investigations have clearly demonstrated that T lymphocytes can mediate the regression of metastatic melanoma. However, not all patients with cancer are eligible for this type of immunotherapy either because resectable tumor is not available, the TIL do not expand sufficiently, or the tumor infiltrating lymphocytes (TIL) that do proliferate do not exhibit sufficient tumor specific reactivity. * We have recently developed techniques for the in vitro isolation and expansion of anti-tumor NK cells to levels suitable for the treatment of cancer patients and are proposing in this protocol to evaluate therapy using these NK cells. * In Surgery Branch pre-clinical experiments, we evaluated lysis of fresh melanoma cell digests, melanoma cell lines, renal cell carcinoma (RCC) lines, and normal peripheral blood mononuclear cells (PBMCs) by NK cells from several patients and demonstrated that NK cells could lyse some fresh melanoma digests, as well as melanoma cell lines and renal cell cancer (RCC) lines, while sparing normal allogeneic and autologous PBMCs. Objectives: * Determine the ability of the administration of autologous natural killer (NK) cells plus aldesleukin (IL-2) following a non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma or kidney cancer. * Determine the rate of repopulation of the natural killer cells in treated patients. * Determine the toxicity of this treatment regimen. Eligibility: * Patients, 18 years of age or older with metastatic melanoma or metastatic kidney cancer who have previously received high dose IL-2, with an Eastern Cooperative Oncology Group (ECOG) of 0 or 1. * Patients may not have any active systemic infections, coagulations disorders, major medical illnesses of the cardiovascular, respiratory or immune systems or any form of autoimmune disease or immunodeficiency. Patients must be eligible to receive high-dose IL-2. Design: * Patients will undergo apheresis on 03-C-0277 (Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols) to obtain cells for generation of autologous natural killer cells. * All patients will receive a non-myeloablative lymphocyte depleting preparative regimen of cyclophosphamide (60 mg/kg/day IV) on days -8 and -7 and fludarabine (25 mg/m\^2/day IV) on days -6 through -2. * On day 0 patients will receive the infusion of autologous natural killer lymphocytes and then begin the first cycle of high-dose IL-2 (720,000 IU/kg IV every 8 hours for up to 15 doses). A second cycle of IL-2 will be administered approximately 14 days later. * Clinical and Immunologic response will be evaluated about 4 to 6 weeks after the second cycle of IL-2. -Using a small optimal Phase II design, two cohorts of patients, initially 16 in each cohort, will be enrolled, and if at least one of the first 16 patients has a clinical response (partial response (PR) or complete response (CR)), accrual will continue to 29 patients, targeting a 15% goal for objective response.

Metastatic Melanoma Metastatic Kidney Cancer

Adoptive Cell Therapy Cutaneous Melanoma Clinical Response Rate of Repopulation Toxicity Profile Metastatic Melanoma Metastatic Kidney Cancer

null

2

arm 1: Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy. arm 2: Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.

[ 0, 0 ]

4

[ 0, 2, 0, 0 ]

intervention 1: Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy. intervention 2: IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. intervention 3: Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. intervention 4: Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2.

intervention 1: Natural Killer (NK) Lymphocytes intervention 2: IL-2 intervention 3: Cyclophosphamide intervention 4: Fludarabine

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00328861

[ 3, 4 ]

229

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.

null

Intermediate Uveitis Posterior Uveitis

null

3

arm 1: Dexamethasone 350 µg arm 2: Dexamethasone 700 µg arm 3: Sham

[ 1, 1, 3 ]

3

[ 0, 0, 0 ]

intervention 1: Dexamethasone 350 µg; injection drug delivery system at Day 0 intervention 2: Dexamethasone 700 µg injection drug delivery system at Day 0 intervention 3: Sham injection at Day 0

intervention 1: Dexamethasone intervention 2: dexamethasone intervention 3: Sham injection

18

Dallas | Texas | United States | -96.80667 | 32.78306 Sydney | N/A | Australia | 151.20732 | -33.86785 Vienna | N/A | Austria | 16.37208 | 48.20849 São Paulo | São Paulo/SP | Brazil | -46.63611 | -23.5475 Montreal | Quebec | Canada | -73.58781 | 45.50884 Prague | N/A | Czechia | 14.42076 | 50.08804 Paris | N/A | France | 2.3488 | 48.85341 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Cholargós | N/A | Greece | 23.8 | 38.0 Hyderabad | N/A | India | 78.45636 | 17.38405 Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Gdansk | N/A | Poland | 18.64912 | 54.35227 Coimbra | N/A | Portugal | -8.41955 | 40.20564 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Seoul | N/A | South Korea | 126.9784 | 37.566 Madrid | N/A | Spain | -3.70256 | 40.4165 Lausanne | N/A | Switzerland | 6.63282 | 46.516 London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00333814

[ 3 ]

85

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

null

This randomized phase II trial is studying atorvastatin calcium to see how well it works compared to oligofructose-enriched inulin, sulindac, or a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia. Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of atorvastatin calcium, oligofructose-enriched inulin, or sulindac may stop cancer from forming in patients at increased risk of colorectal neoplasia. It is not yet known whether atorvastatin calcium, oligofructose-enriched inulin, or sulindac are more effective than a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia.

PRIMARY OBJECTIVE: I. Percent change in number of rectal aberrant cryptic foci (ACF) as measured by magnification chromoendoscopy SECONDARY OBJECTIVES: I. Screening for possible phase III testing II. Effects on proliferation (Ki67 expression) and apoptosis (caspase-3 expression) as measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment III. Correlation of endoscopic features with histologic characteristics of rectal ACF IV. Observation of the natural history of rectal ACF in patients receiving placebo V. Adverse events VI. Utilization of a biospecimen repository archive OUTLINE: This is a multicenter, prospective, randomized, partially blinded, placebo-controlled study. Patients are stratified according to history of prior surgical resection of the colon (yes vs no) and number of rectal aberrant cryptic foci (ACF) (5-9 vs \>= 10). Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive oral atorvastatin calcium once daily. ARM II: Patients receive oral sulindac twice daily. ARM III (blinded arm): Patients receive oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily. ARM IV (blinded arm): Patients receive an oral placebo twice daily. In all arms, treatment continues for 6 months in the absence of unacceptable toxicity. Tissue samples are collected at baseline and at the completion of study treatment. Tissue is examined by immunohistochemistry for proliferation (Ki67) and apoptosis (cleaved caspase-3). After completion of study treatment, patients are followed at approximately 30 days.

Colon Cancer Precancerous Condition Rectal Cancer

null

4

arm 1: Patients receive oral atorvastatin once daily. arm 2: Patients receive oral sulindac twice daily. arm 3: Patients receive oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily. arm 4: Patients receive an oral placebo twice daily.

[ 0, 0, 0, 2 ]

5

[ 0, 0, 0, 0, 10 ]

intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally intervention 4: Given orally intervention 5: Correlative studies

intervention 1: oligofructose-enriched inulin intervention 2: sulindac intervention 3: placebo intervention 4: atorvastatin calcium intervention 5: laboratory biomarker analysis

1

Rochester | Minnesota | United States | -92.4699 | 44.02163

0

NCT00335504

[ 5 ]

64

NON_RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

null

This is a research study looking at Migranal (study drug) in the treatment of two migraine attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache. Understanding more about allodynia may help us understand how the pain system works in migraine. This study will compare the differences, if any, in attacks treated early with study drug (at 1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one attack early and one attack late for this study. If the first attack you treat is early (at 1 hour following onset of throbbing pain) then the second attack you treat should be late (at 4 hours following onset of throbbing pain). It is hoped that this study will provide information on the use of Migranal in subjects who have cutaneous allodynia. The results from this study may be used in the development of larger clinical trials. The study drug is a medication that is taken in the form of nasal spray.

This is a three visit trial consisting of a screening visit, one follow-up visit and a termination visit. Subjects will be screened using the Cutaneous Allodynia Screening Tool (Appendix A) and the investigator will determine whether or not the subject experiences episodic migraine headaches associated with cutaneous allodynia. Those subjects who test positive for the afore-stated will then proceed with the treatment phase of the project. Migranal® will be taken by the subject at home at 1-hour following the onset of throbbing pain for one of the two qualifying migraine attacks and at 4-hours following onset of throbbing pain for the second qualifying migraine attack. Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose. Cutaneous allodynia assessments will be made periodically prior to and after administration of study drug. Subjects will be asked to return to the center within 1 week of treating each attack. Subjects will be instructed to treat their 1st qualifying attack within 6 weeks of the screening visit and their 2nd qualifying attack within 6 weeks of their follow-up visit 1. Migraine pain and associated symptoms assessments will be measured by the subjects for 24-hours from the administration of study drug for each attack.

Migraine

null

2

arm 1: All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase). arm 2: All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase).

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose. intervention 2: Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.

intervention 1: Migranal nasal spray at 1 hour intervention 2: Migranal nasal spray at 4 hour

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00335777

[ 3 ]

7

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy 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 oxaliplatin and capecitabine together with radiation therapy works in treating patients with stomach cancer that can be removed by surgery.

OBJECTIVES: * Determine the pathologic complete response rate in patients with primary gastric adenocarcinoma treated with neoadjuvant chemoradiotherapy comprising oxaliplatin, capecitabine, and radiotherapy. (This will not be completed as this study was closed early due to poor accrual.) * Assess the frequency and severity of toxicities associated with this regimen. * Explore, preliminarily, the association between DNA repair genes (ERCC-1, XRCC1, GST-P1, XPD, XPA, ribonucleotide reductase), target enzymes (thymidylate synthase \[TS\], dihydropyrimidine dehydrogenase, thymidine phosphorylase \[TP\]), and angiogenic factors (vascular endothelial growth factor \[VEGF\], epidermal growth factor \[EGF\], PD-ECGF, basic fibroblast growth factor, TSP-1 and -2, transforming growth factor \[TGF\]-β, and IL-8) and response to neoadjuvant therapy in patients with adenocarcinoma of the stomach. (This will not be completed as this study was closed early due to poor accrual.) * Explore, preliminarily, the association of haplotypes of candidate genes of TS, TP, ERCC-1, XPD, GST-P1, cyclooxygenase-2, EGF receptor, TGF-β, VEGF, and IL-8 with response and toxicity to neoadjuvant chemoradiation therapy in these patients. (This will not be completed as this study was closed early due to poor accrual.) * Explore, preliminarily, the feasibility of performing comparative genomic hybridization for analysis of DNA copy number changes in predicting response to neoadjuvant chemoradiation therapy. (This will not be completed as this study was closed early due to poor accrual.) OUTLINE: This is a multicenter, pilot study. * Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on days 1 and 22 and oral capecitabine twice daily on days 1-14 and 22-35 in the absence of disease progression or unacceptable toxicity. * Neoadjuvant chemoradiotherapy: Patients receive oral capecitabine twice daily on days 43-77 and undergo radiotherapy once daily on days 43-47, 50-54, 57-61, 64-68, and 71-75 in the absence of disease progression or unacceptable toxicity. * Surgery: Patients with stable or responding disease undergo surgery 4-6 weeks after completion of chemoradiotherapy. Tumor tissue is obtained at surgery or endoscopic biopsy. Gene expression analysis and comparative genomic hybridization testing are conducted on the tissue. Blood is drawn prior to beginning study treatment and is analyzed for germline polymorphisms. After completion of study treatment, patients are followed periodically for up to 3 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Gastric Cancer

adenocarcinoma of the stomach stage I gastric cancer stage II gastric cancer stage III gastric cancer

null

1

arm 1: Chemotherapy: Oxaliplatin, 130 mg/m2, 2 hour IV infusion on Days 1 and 22; Capecitabine 850 mg/m2/dose, PO q 12 hours on Days 1-14 and 22-35 Chemoradiation: Capecitabine 650 mg/m2/dose, PO q 12 hours on days 43-77; Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Surgery: Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy

[ 0 ]

4

[ 0, 0, 3, 4 ]

intervention 1: 850 mg/m2/dose PO q 12 hours Days 1-14 and 22-35. 650 mg/m2/dose PO q 12 hours Days 43-77. intervention 2: 130 mg/m2 by 2-hour infusion Days 1 and 22 intervention 3: Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy intervention 4: Beginning Day 43, patients will be treated 5 days/week at 180 cGy/day times 25 fractions to a total dose of 4,500 cGy.

intervention 1: capecitabine intervention 2: oxaliplatin intervention 3: conventional surgery intervention 4: radiation therapy

75

0

NCT00335959

[ 3 ]

120

RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.

null

Carcinoma, Renal Cell

null

1

arm 1: Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

[ 0 ]

1

[ 0 ]

intervention 1: Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

intervention 1: Sunitinib malate

15

0

NCT00338884

[ 3 ]

18

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study prospectively evaluates a multidisciplinary approach to patients with intraperitoneal carcinomatosis at Washington University. Patients with peritoneal carcinomatosis or pseudomyxoma peritonei will undergo debulking surgery with peritonectomy and placement of adhesive barrier film followed by repeated delayed intraperitoneal chemotherapy with 5FU with systemic oxaliplatin-based chemotherapy on a biweekly schedule. A retrospective review of patients treated in a similar manner at our institution showed good tolerance and efficacy. This formal Phase II study is planned to determine the safety, toxicities and survival of patients with peritoneal carcinomatosis and pseudomyxoma peritonei treated with this regimen.

null

Peritoneal Neoplasms

null

1

arm 1: * Surgical debulking with peritonectomy * IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles. * FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.

[ 0 ]

3

[ 3, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Surgical debulking with peritonectomy intervention 2: Intraperitoneal 5FU intervention 3: FOLFOX

1

St Louis | Missouri | United States | -90.19789 | 38.62727

0

NCT00352755

[ 3 ]

41

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to help answer: * Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last * Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer

null

Lung Neoplasms

null

4

arm 1: Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy arm 2: Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy arm 3: Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy arm 4: Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression intervention 2: 1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression intervention 3: area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression intervention 4: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression

intervention 1: pemetrexed intervention 2: gemcitabine intervention 3: carboplatin intervention 4: Pemetrexed

17

0

NCT00356525

[ 5 ]

1,976

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.

Pfizer announced in October 2007 that it would stop marketing Exubera. At that time, Pfizer committed to continued marketing until it returned the licensing rights for the technology to Nektar. Following the announcement, enrollment was halted. Subjects already enrolled and receiving treatment at the time of the halt in enrollment could continue in the study in accordance with the protocol. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, an amendment was filed on April 16, 2008 specifying that all subjects randomized to Exubera had to be transitioned to usual diabetes care, and all study subjects followed for serious adverse events for 6 months. In accordance with this amendment, study A2171069 was terminated on April 29, 2009. Neither safety nor efficacy reasons were the cause of the study termination.

Diabetes Mellitus

Large Simple Trial

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions. intervention 2: Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).

intervention 1: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care intervention 2: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care

197

0

NCT00359801

[ 3, 4 ]

17

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study will evaluate how heartburn may lead to different types of inflammation in one's airways. Additionally, the study will determine whether aggressive treatment of heartburn results in improvement in both symptoms of heartburn and asthma but also in documented improvement in airway inflammation as determined by biopsy. The results of this study will be important in directing future research into the relationship between heartburn and asthma and may provide a clue whether certain subtypes of asthma may be caused primarily by gastroesophageal reflux (GER).

Currently, many Americans suffer from asthma. The exact mechanism by which airway inflammation leads to asthma symptoms has yet to be clearly explained. In previous studies, persons with asthma appear to have different types of inflammation in their lungs. The reasons for this difference remain a mystery. Allergy is known to play a role in bronchospasm. Other mechanisms have not been discovered. It is known that asthma and heartburn are correlated. Studies have confirmed a direct relationship between cough and heartburn (Gastroesophageal reflux). Other researchers have determined that asthma is often worsened by GER. Determination of the exact relationship between these two entities remains unclear. Heartburn may contribute to airway inflammation in asthmatics, resulting in different patterns of inflammation between those people with and without GER. In fact, adult-onset asthma may result primarily from longstanding heartburn. This has yet to be proven. This study will evaluate how heartburn may lead to different types of inflammation in one's airways. Additionally, the goal of this study is to determine whether aggressive treatment of heartburn results in improvement in both symptoms of heartburn and asthma but also in documented improvement in airway inflammation as determined by biopsy. The results of this study will be important in directing future research into the relationship between heartburn and asthma and may provide a clue whether certain subtypes of asthma may be caused primarily by GER. A total of 30 subjects will be studied, randomized to twice daily lansoprazole or placebo. Study procedures are as follows: A. Esophageal studies and validated questionnaires: Patients will be evaluated with validated SF-36 Quality of Life Questionnaire, Mini-asthma Quality of Life Questionnaire, and GER Questionnaire. Patients will undergo esophageal manometry and pH detection with a 24- hour pH probe to confirm the presence of pathologic GER. B. Bronchoscopy: After an overnight fast, subjects will report to the bronchoscopy suite as directed. Bronchoscopy with bronchoalveolar lavage (BAL) and bronchial biopsy will be performed following the University of Utah's standardized protocol. Bronchoscopy and endobronchial biopsies present minimal risk to asthmatic airways when performed by appropriate, trained personnel. Conscious sedation with intravenous remifentanyl and propofol will be administered by a trained nurse experienced in conscious sedation. The nose and pharynx will be anesthetized with 1% lidocaine administered by nebulization and by lidocaine jelly administered topically to the nasal mucosa. Additional lidocaine will be administered via the bronchoscope to the vocal cords, trachea, main carina and mainstem bronchi. The total dose of lidocaine will not exceed 400 mg. All subjects will have continuous cardiac and oxygen saturation monitoring and will receive supplemental oxygen during the procedure sufficient to maintain SpO2 \> 90%. The subject will be placed in a recumbent position and the bronchoscope will be introduced via the nose. After passing the vocal cords, the bronchoscope will be introduced via the right mainstem bronchus into the right middle lobe where it will be wedged into a segmental bronchus. (Should, for any reason, the right middle lobe be inaccessible, the same procedure will be used to wedge the bronchoscope into a lingular segment in the left lung.) A 60 cc aliquot of room temperature normal saline will be instilled through the bronchoscope and recovered using the same syringe. This procedure will be repeated three more times (total lavage volume of 240 cc) and the recovered volumes will be pooled and measured. Forceps biopsies of respiratory mucosa will then be taken from the trachea, main carina, bronchus intermedius and right middle lobe areas. Two to six biopsies will be taken from each site. Specific tissue from each site will be frozen and stored for future use. Individuals will be randomized to lansoprazole 30 mg twice daily or placebo (all patients will undergo lifestyle modification for reflux) for 6 weeks. It has been determined in previous studies that higher levels of acid suppression are needed to result in clinical improvement in asthma. Patients will be monitored by telephone at regular intervals. Rescue inhaler use, hospitalizations, exercise tolerance, and study compliance will be assessed and recorded to document clinical progress. Patients will be asked to maintain their standard inhaler therapy (especially that of inhaled steroids). Any changes to the therapy will be immediately reported to the investigators. If subjects experience an acute flare, appropriate medications will be given until the patient is stable to return to their initial inhaler regimen. If patients remain on stable medication throughout the trial, repeat bronchoscopy will be performed at 6 weeks. After 6 weeks, patients will once again undergo bronchoscopy with BAL/biopsies. Cytokine protein arrays will be repeated. Comparisons will then be made intra-group before and after therapy. Additional comparisons of inflammation and bronchial hyper-responsiveness will be made between groups. Randomization will allow the investigators to control for any changes in cytokine patterns due to seasonal affect (if both groups reduce the concentration of Interleukin-5 in a similar pattern, this is more likely seasonal than due to acid suppression). Primary outcome will include change in cellular infiltration in the bronch specimens of lymphocytes. Secondary outcome will include RNA expression changes of tumor necrosis factor (TNF) alpha from BAL samples.

Gastroesophageal Reflux Asthma

null

2

arm 1: Lansoprazole 30 mg orally twice daily arm 2: placebo orally twice daily

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 30 mg of lansoprazole twice daily for 6 weeks intervention 2: placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks

intervention 1: lansoprazole intervention 2: placebo

1

Salt Lake City | Utah | United States | -111.89105 | 40.76078

0

NCT00361972

[ 5 ]

500

RANDOMIZED

FACTORIAL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study, which is being conducted at 100 centers throughout the United States, is to determine whether Lantus, a long-acting insulin injection, either alone or in combination with metformin, is effective in reducing C-reactive protein (CRP) in adults with type 2 diabetes. CRP is a marker of chronic low-level inflammation, a new risk factor for diabetes, heart attack, stroke, and other cardiovascular events.

Study Rationale Low-grade systemic inflammation as indicated by elevated levels of C-reactive protein (CRP) is often present in patients with type 2 diabetes. Individuals with type 2 diabetes represent a vulnerable population in which cardiovascular event rates are high and among whom CRP reduction may have the greatest impact. While several classes of oral hypoglycemic agents have been shown to lower CRP, data are not available for newer formulations of long-acting insulins such as Lantus (insulin glargine injection) and no study has comprehensively evaluated the relative merit of insulin-providing versus insulin-sensitizing strategies for this purpose. Investigational Plan This is a multicenter, community-based, randomized 2x2 factorial trial of Lantus and metformin among patients with type 2 diabetes treated with either diet or oral monotherapy (other than metformin) only who have poor glycemic control and elevated CRP. The primary endpoint is change in CRP. Secondary endpoints include improvement in insulin sensitivity, glycemic control, blood lipids, as well as selected inflammatory and prothrombotic markers, and adipokine levels. Limited data suggest that short-term insulin administration in patients with poorly controlled type 2 diabetes may lower CRP, but the benefit of CRP reduction that is unique to insulin therapy and independent of glycemic control per se remains uncertain. The insulin-sensitizing agent metformin, a mainstay of anti-diabetic therapy, has been shown to reduce macrovascular complications among patients with type 2 diabetes and, in some but not all randomized clinical trials, also has a modest CRP-lowering effect. This study is designed to assess whether the use of Lantus either alone or in combination with metformin lowers CRP over a 14-week treatment period. Eligible men and women age 18 to 79 years with early diabetes on diet only or oral monotherapy with baseline HbA1c 7.0-10% and CRP greater than or equal to 2.0 mg/l will be randomized in a 2X2 factorial fashion as follows. First, participants will be assigned at random to open-label Lantus or no insulin. Then, within these two categories, subjects will be assigned at random to metformin or placebo. Thus, the four resultant treatment groups are Lantus injection and placebo pill, Lantus injection and metformin pill, metformin pill alone, and placebo pill alone. All patients will receive diet and exercise counseling. This study design will permit testing of the overall effect of Lantus as well as the effect of combination therapy with metformin for CRP reduction at a targeted level of glycemic control (fingerstick fasting blood glucose \< 110 mg/dl). All participants will be provided with a glucometer for fingerstick glucose testing calibrated to report plasma-referenced values.

Type 2 Diabetes

type 2 diabetes insulin insulin injection metformin C-reactive protein insulin sensitivity glycemic control inflammation

null

4

arm 1: Placebo pill arm 2: Metformin pill arm 3: Insulin glargine plus placebo pill arm 4: Insulin Glargine plus metformin pill

[ 2, 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Once daily for 14 weeks intervention 2: Up to 4 pils per day (2g per day) maximum intervention 3: Up to 4 pills per day

intervention 1: Insulin glargine injection intervention 2: metformin intervention 3: Placebo pill

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00366301

[ 5 ]

291

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23 months, with AOM will be enrolled in the study. They will be treated either with Augmentin (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will be asked to write information about their child in a Patient Diary. A general physical exam, including an ear exam, will be performed 4 times during the study. A mucus sample will be collected from the back of each child's nose. Parents will be asked questions during phone calls and at every visit. If a child has not improved or has worsened, the investigators will prescribe a different antibiotic that is known to kill resistant germs.

The purpose of this randomized, double-masked, placebo-controlled, single-center clinical trial is to determine the efficacy of antimicrobials in young children with acute otitis media (AOM). The primary objectives are to compare time to resolution of symptoms (initial and sustained) in children receiving amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses for 10 days) to children receiving placebo (in 2 divided doses for 10 days), and to compare the weighted average AOM-Severity of Symptoms (AOM-SOS) scores in the two groups during days 1-7. The secondary objectives are to: evaluate the clinical efficacy of amoxicillin-clavulanate vs. placebo at the on-therapy visit (Day 4-5, and at least 72 hours after initial dose of study medication); evaluate the clinical efficacy of amoxicillin-clavulanate vs. placebo at the end-of-therapy visit (Day 10-12); compare AOM-SOS and AOM-Faces scales between treatment groups during each of the first 7 days of therapy and at all study visits; compare the proportion of children in each treatment group who develop worsening symptoms before having received 72 hours of study medication; compare the two treatment groups regarding the quantity of analgesic medication administered by children's parents; compare the incidence of adverse events accompanying the two treatment regimens; compare the effects of amoxicillin-clavulanate vs. placebo on the overall proportion of children with nasopharyngeal (NP) colonization with AOM pathogens (S. pneumoniae, H. influenzae, M. catarrhalis, S. pyogenes), and on the proportion of children with NP colonization with penicillin non-susceptible S. pneumoniae; compare the 2 treatment groups regarding tympanometric outcomes at the on-therapy (Day 4-5), end-of-therapy (Day 10-12) and follow-up (Day 21-25) visits, using an algorithm that permits estimation of the probability of middle ear effusion given any particular tympanographic configuration; compare direct and indirect medical costs between the two treatment groups; and compare parental satisfaction with therapy between the two treatment groups. Participants will include 268 children, aged 6 to 23 months, diagnosed with acute otitis media in Western Pennsylvania. These participants will be recruited into the study at Children's Hospital of Pittsburgh (CHP), Pittsburgh, PA, and Armstrong Pediatrics (Children's Community Pediatrics: an affiliate of CHP) in Kittanning, PA. Subjects will be randomized to receive either amoxicillin-clavulanate or placebo twice daily for 10 days. Parents of the subject will be asked to track symptom status, medication use (study medication and acetaminophen), fever and diarrhea in a study memory aid. Study procedures will include a medical history, vital signs, weight, clinical information regarding signs and symptoms of infection, nasopharyngeal specimens, and a physical exam including tympanometry. Each child will be examined three additional times: 4-5 days after starting the medicine, study day 10-12 and 21-25 days after enrolling in the study. During these visits, study staff will review the child's symptoms and examine the child's ears. The study staff will also obtain a nasopharyngeal culture in order to look for resistant bacteria and to make appropriate changes in antibiotic treatment. Daily telephone assessments will be made by study staff on days 2, 3, and 4 of therapy to make sure the child is getting better. The study staff will see a child anytime a parent feels their child has not improved or has worsened.

Acute Otitis Media

acute otitis media, infants, children

null

2

arm 1: Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days. arm 2: Reconstituted placebo in 2 divided doses for 10 days.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Augmentin ES-600™: Amoxicillin-clavulanate potassium (600/42.9 mg per 5 mL), administered at a dose of 90/6.4 mg/kg/day in 2 divided doses for 10 days with strawberry cream flavor. intervention 2: Same base formulation of the licensed product Augmentin ES-600™, with the same strawberry cream flavor.

intervention 1: amoxicillin-clavulanate intervention 2: Placebo

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00377260

[ 3 ]

10

null

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis.

OBJECTIVES: Primary * Determine the efficacy of azacitidine in patients with myelofibrosis (MF) with myeloid metaplasia. * Evaluate the safety of azacitidine in these patients. Secondary * Evaluate pertinent biologic characteristics of MF before and during therapy with azacitidine. * Assess the effects of study treatment on constitutional symptoms in these patients. * Estimate time to event distributions for overall survival and progression. OUTLINE: Patients receive azacitidine subcutaneously once daily on days 1-5. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 3 years. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Chronic Myeloproliferative Disorders Secondary Myelofibrosis

primary myelofibrosis polycythemia vera essential thrombocythemia secondary myelofibrosis

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: azacitidine

2

0

NCT00381693

[ 3, 4 ]

1

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The primary objective of this protocol is to look at whether Lucentis (ranibizumab) is safe and effective when used for macular edema (retinal swelling) due to Eales' disease. The secondary objective is to see if macular edema comes back within three months after the last dose of study drug is given.

This is a six-month study. Eligible subjects will receive one injection of the study drug into one eye for each of three months. Visual acuity, blood pressure and eye pressure will be tested. Subjects' retinas will be examined and thickness measured by optical coherence tomography (OCT). Safety visits will be scheduled for the week after the injections. The investigators will monitor the subjects' eyes for infection and inflammation. After the three-month treatment period, subjects will return to the clinic monthly for four follow-up visits. Procedures and tests that will be performed at the follow-up visits include visual acuity, a retinal exam including OCT, blood pressure, and eye pressure.

Eales' Disease

Eales

null

1

arm 1: Lucentis (ranibizumab)

[ 0 ]

1

[ 0 ]

intervention 1: Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months

intervention 1: Ranibizumab

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00384449

[ 4 ]

930

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.

Studies throughout the world have shown that insomnia is a common complaint that occurs in 10-50% of the population depending on age, sex and country. Among the wide variety of available treatments of sleep disturbances, the most commonly prescribed hypnotics are the benzodiazepines (BZD) and non-BZD hypnotics. However, these hypnotics were often associated with rebound, dependency, tolerance, higher risk of falls mainly in the elderly population, anterograde memory disturbances and increased risk for motor accidents the next day. In response to the unmet clinical need for a safe and efficacious alternative treatment for primary insomnia, that in addition to treating quantitative sleep problems, would improve sleep quality and daytime functioning, a clinical development program on melatonin for the treatment of primary insomnia was initiated. This study is conducted using a randomised, double-blind, placebo controlled parallel group design, after a single-blind placebo period. Primary insomnia patients aged 18-80 will be screened for entry into the study. After the initial 3 weeks double-blind treatment period, patients will be given the option to enter a six-month double-blind continuation study. Primary parameter is sleep latency, secondary parameter is sleep maintenance. Exploratory parameters are total sleep time, sleep quality, morning alertness and quality of life.

Primary Insomnia

Primary insomnia as defined by DSM IV criteria

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Prolonged release melatonin 2 mg intervention 2: placebo circadin tablets

intervention 1: Circadin intervention 2: placebo circadin

1

Glasgow | N/A | United Kingdom | -4.25763 | 55.86515

0

NCT00397189

[ 5 ]

6

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors (SSRIs). The hypotheses of this study are that:1. subjects with major depression or dysthymia who are being treated with an SSRI and experiencing treatment-related sexual dysfunction will experience less sexual dysfunction if they are switched to duloxetine, and 2. they will experience either improved antidepressant response or no loss of antidepressant response.

In this study, subjects suffering from depression or dysthymia and experiencing treatment-emergent sexual dysfunction from an SSRI are switched from their SSRI to duloxetine to determine whether or not they experience improved sexual function and equal or improved antidepressant response. Study subjects are assigned to receive open label duloxetine for 12 weeks at either 60mg per day or 120mg per day after discontinuing their current antidepressant

Depression

null

1

arm 1: Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)

[ 0 ]

1

[ 0 ]

intervention 1: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks

intervention 1: Duloxetine

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00398632

[ 3 ]

1,101

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

The purpose of this study is to test the hypothesis that the inhibition of the renin-angiotensin-aldosterone system (RAAS) with the angiotensin receptor blocker valsartan or the renin antagonist aliskiren will improve ventricular hemodynamics, as reflected by a greater reduction in levels of N-terminal proB-type natriuretic peptide (NT-proBNP) compared to placebo in subjects stabilized following acute coronary syndrome (ACS) who are determined to be at high risk due to an elevated concentration of natriuretic peptides.

null

Post Acute Coronary Syndrome Myocardial Ischemia

Post acute coronary syndrome Acute coronary syndrome B-type natriuretic peptide N-terminal pro-B-type natriuretic peptide myocardial infarctions

null

4

arm 1: Placebo tablets and capsules arm 2: Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. arm 3: Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. arm 4: Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Placebo tablets and capsules. In order to adequately blind the study, patients were required to take a total of 1 tablet and 2 capsules during the first 4 weeks of the study. During the remainder of the study, patients were required to take 2 tablets and 2 capsules. Each dose was taken by mouth with water at approximately 8:00 AM with or without food. intervention 2: Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM. intervention 3: Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM. intervention 4: Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. If a patient was not up-titrated or required down-titration, the patient continued on that dose for the remainder of the study. If 2 down-titrations were required, they stopped study drug. In order to adequately blind the study, patients were required to take 1 tablet and 2 capsules during the first 4 weeks of the study and 2 tablets and 2 capsules for the remainder of the study. Each dose was taken by mouth with water at approximately 8:00 AM.

intervention 1: Placebo intervention 2: Aliskiren 300 mg intervention 3: Valsartan 320 mg intervention 4: Aliskiren/valsartan 300/320 mg

11

Investigative Site | New Jersey | United States | N/A | N/A Investigative Site | N/A | Belgium | N/A | N/A Investigative Site | N/A | Canada | N/A | N/A Investigative Site | N/A | Czechia | N/A | N/A Investigative Site | N/A | Germany | N/A | N/A Investigative Site | N/A | Hungary | N/A | N/A Investigative Site | N/A | Netherlands | N/A | N/A Investigative Site | N/A | Poland | N/A | N/A Investigative Site | N/A | Russia | N/A | N/A Investigative Site | N/A | Spain | N/A | N/A Investigative Site | N/A | Sweden | N/A | N/A

0

NCT00409578

[ 3 ]

465

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.

null

Hepatitis C

Genotype 1

null

4

arm 1: Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks. arm 2: Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. arm 3: Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks. arm 4: Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: tablet intervention 2: tablet intervention 3: Solution for injection intervention 4: Tablet

intervention 1: Telaprevir intervention 2: Ribavirin intervention 3: Pegylated Interferon Alfa 2a intervention 4: Matching Placebo

53

0

NCT00420784

[ 4 ]

32

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.

null

GERD

neonates infants GERD reflux

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Esomeprazole

3

North Adelaide | N/A | Australia | 138.59141 | -34.90733 Aachen | N/A | Germany | 6.08342 | 50.77664 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297

0

NCT00427635

[ 4 ]

171

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug. The study was designed to detect a 50% improvement in median PFS\[Progression Free Survival\] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred. Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC \[Data Monitoring Committee\]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.

The study was terminated on 11 March 2009 because the independent Data Monitoring Committee determined that the study had met its primary endpoint in demonstrating improvement in progression-free survival. The decision to terminate the trial was not based on safety concerns related to sunitinib administration.

Carcinoma, Islet Cell Carcinoma, Pancreas

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: * sunitinib malate oral starting dose 37.5 mg daily (continuous dosing). * Dose may be decreased to 25 mg daily in case of adverse events. * It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment. * Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination. intervention 2: Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.

intervention 1: sunitinib malate intervention 2: Placebo

54

0

NCT00428597

[ 4 ]

4

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

2MALE

true

The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe, long term improvement of lower urinary tract symptoms.

Benign Prostatic Hyperplasia (BPH) is the most common neoplastic condition afflicting middle-aged and elderly men. BPH is a non-cancerous condition in which the prostate becomes enlarged which can cause lower urinary tract symptoms (LUTS). These symptoms include: frequency, urgency, weak urinary stream, difficulty starting or stopping to urinate and feeling the need to urinate even after just finishing urinating. One of the minimally invasive treatments for BPH is a Laser TURP. The men going into this study would be planning on having a Holmium Laser TURP at Northwestern Memorial Hospital in Chicago, Illinois. Another treatment for BPH is the use of a class of drugs called 5-Alpha Reductase Inhibitors (5ARI). Dutasteride is a 5ARI that has been approved by the U.S. Food and drug Administration (FDA) for the treatment of BPH. Each participant in this study will be randomized into ONE of the treatment groups below: 1. Laser TURP combined with Dutasteride 2. Laser TURP combined with placebo. This study is double-masked which means neither the participant, nor the study staff will know who is receiving active study drug or placebo. There will be a 50% chance of receiving the study drug, Dutasteride, and a 50% chance of receiving a placebo. Dutasteride or it's placebo comes as a 0.5mg capsule to be taken by mouth once a day at bedtime. There will be a screening period that may last up to 8 weeks. It will include: * There will be 2 or 3 screening visits to the clinic with each visit lasting approximately 2.5 to 3 hours. * Each participant will be asked to complete various forms and questionnaires regarding their lower urinary tract symptoms and how they effect them and their sexual function. * No study drug will be taken during this time. * The Laser TURP at Northwestern Memorial Hospital will be scheduled. If each requirement has been met and it is determined that the participant is eligible to participate in this trial the participant will come to the clinic for a randomization visit. At this visit the participant will be randomized into one of the two treatment groups noted above. Randomization is like a flip of a coin and neither the participant, nor the study staff chooses which treatment will be given. Each participant will start taking the study drug everyday for six weeks before undergoing the Laser TURP and will continue taking the study drug every day for one year after the Laser TURP. If the Laser TURP requires having a catheter in place, the participant will be seen by the urology clinic staff for follow up visits for this catheter. This follow up schedule may require weekly visits. There will be follow up visits with the research staff. The participant will be asked to come to the research clinic every three months for one year. Each follow up visit will last approximately 1.5 hours. A final visit will take place at one year. This will be identical to the first screening visit. This visit will last approximately 2 hours. If the participant decides to withdraw from this study early he will be asked to come into the office for an early withdrawal visit. Please note: The above detailed information regarding this research study is not in it's entirety. All of the above and more will be discussed in complete detail upon meeting with a research staff member or by calling the contact person mentioned in this protocol registration below.

Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Lower Urinary Track Symptoms Laser Transurethral Prostate

null

2

arm 1: Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient arm 2: Prior to and after standard treatment with laser TURP, placebo is applied to each patient

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: Placebo before and after treatment of TURP

intervention 1: Dutasteride (Avodart) intervention 2: Placebo

0

null

0

NCT00431626

[ 3 ]

214

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This Phase II, multicenter, randomized, double-blind, placebo-controlled trial was designed to estimate the efficacy and characterize the safety of bevacizumab when combined with carboplatin + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy alone in patients with previously untreated metastatic melanoma.

null

Melanoma

Avastin BEAM Metastatic melanoma

null

2

arm 1: None arm 2: None

[ 2, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 15 mg/kg by intravenous (IV) infusion on the first day of each 3-week cycle (dose was based on patient's weight at screening and remained the same throughout study) intervention 2: Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 3-week cycle, for a maximum of 10 cycles intervention 3: 175 mg/m\^2 by IV infusion on the first day of each 3-week cycle (dose was based on patient's weight and could be adjusted for weight change) intervention 4: Administered by IV infusion on the first day of each 3-week cycle

intervention 1: bevacizumab intervention 2: carboplatin intervention 3: paclitaxel intervention 4: placebo

0

null

0

NCT00434252

[ 4 ]

355

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with Human Immunodeficiency Virus (HIV).

null

HIV Infection

treatment experienced

null

2

arm 1: Raltegravir \& Placebo arm 2: Lopinavir (+) Ritonavir \& Placebo

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: raltegravir 400 milligram (mg) by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment intervention 2: lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment intervention 3: lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment intervention 4: raltegravir 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment

intervention 1: Comparator: raltegravir intervention 2: Comparator: placebo intervention 3: Comparator: lopinavir (+) ritonavir intervention 4: Comparator: placebo

0

null

0

NCT00443729

[ 3, 4 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study will investigate the hypothesis that the analgesic effect of a single injection of Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar fasciitis.

null

Chronic Plantar Fasciitis

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 2, 0 ]

intervention 1: Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia intervention 2: 0.9% sodium chloride: 2 ml injected at the root of the plantar fascia

intervention 1: Botulinum toxin type A intervention 2: Placebo

6

Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Karlsruhe | N/A | Germany | 8.40444 | 49.00937 Marburg | N/A | Germany | 8.77069 | 50.80904 Munich | N/A | Germany | 11.57549 | 48.13743 Weiden | N/A | Germany | 12.15613 | 49.67682

0

NCT00447876

[ 5 ]

628

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

null

Asthma

FLOVENT fluticasone 12 month salmeterol asthma ADVAIR

null

2

arm 1: Fluticasone propionate 250 mcg BID arm 2: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID

81

0

NCT00452348

[ 5 ]

27

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a pilot study to evaluate the effect of dexmedetomidine in the prevention of delirium in non-cardiac surgical patients. The preliminary data regarding the effect of dexmedetomidine on delirium comes from a study underway at Stanford. We propose to randomize fifty patients into two different protocols, one using dexmedetomidine until PACU discharge (hip replacement) and the other using dexmedetomidine for 24 hours in a monitored setting.

Elderly patients who undergo anesthesia and non-cardiac surgery are subject to deterioration of brain function including the development of postoperative delirium (PD) and postoperative cognitive dysfunction (POCD). These disorders cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use relatively primitive approaches to preventing and treating PD and POCD. The proposed is a pilot study for an NIH grant which was recently submitted. This is a randomized controlled trial of perioperative dexmedetomidine to prevent PD and, potentially, POCD. Fifty patients will be enrolled at Mount Sinai with two different surgeries, either hip replacement or vascular bypass. The patients undergoing hip replacement will receive dexmedetomidine until discharge from the PACU. Vascular surgery patients who are transferred from the PACU to a monitored step-sown unit will continue dexmedetomidine for 24 hours.Participants will be screened for Mild Cognitive Impairment (MCI), and undergo preoperative cognitive testing. Unlike the parent trial, we will test for but will not select for patients with MCI. Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Follow up studies will include surveillance for delirium while in the hospital and cognitive testing at 3 months following surgery. Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.

Postoperative Delirium PD Postoperative Cognitive Dysfunction POCD

Postoperative delirium PD Postoperative cognitive dysfunction POCD

null

2

arm 1: Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU. arm 2: Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively or until discharge from the PACU.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Dexmedetomidine started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU. intervention 2: Matching placebo given prior to surgery and continued for 24 hours postoperatively

intervention 1: Precedex (Dexmedetomidine) intervention 2: Placebo

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00455143

[ 5 ]

62

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

Will metformin improve exercise capacity in chronic heart failure patients who has insulin resistance (pre-diabetic- means before they become diabetic)?

Exercise incapacity is one of the major debilitating symptoms of heart failure patients. Studies showed that heart failure patients will become insulin resistance (IR) or vice versa, severity of heart failure also correlates with the severity of insulin resistance. A recent study demonstrated that if we correct diabetic patient insulin resistance by giving them a drug to make them more sensitive to the effects of insulin, their exercise capacity improves. Therefore, we think that the same effects might happen in heart failure patients who have been identified to the insulin resistance by blood test. Insulin resistance means that they have not yet become diabetic and it is a stage the diabetic patients go through before they develop diabetes. Therefore, we plan to use a drug called metformin (a diabetic drug), give it to heart failure patients who also have IR for 4 months and examine the effects before and after 4 months of treatment. It is a double blind control study, therefore, neither the examiner nor the patient know which drug they receive (either active drug- Metformin, or a placebo). The main objective is to assess their exercise capacity using an exercise test called Innocor System. It is a bicycle based exercise test that involves patient breathing into a mouth piece before and during exercise in order for the machine to work out the maximum oxygen consumption and pumping power of the heart. The other objectives of the trial are looking at the possible mechanisms of improving exercise capacity. We aim to answer the following questions by doing the following tests: Does exercise capacity improve because of 1. The effect of metformin on the heart? We will answer this question by doing an ultrasound scan of the heart (Echocardiography) 2. The effects on the blood vessels? We plan to perform a test called flow-mediated dilatation, it is an ultrasound scan of the artery in the arm and also assess the blood flow in the skin using a test called Laser Doppler scan (small amount of medication will be delivered through a small electric current and the blood vessels response will be assessed using the laser doppler scan) 3. The effects on the muscle? We will do a muscle biopsy looking at the enzymes activities in the muscle before and after taking 4 months of medication.

Congestive Heart Failure Insulin Resistance

Chronic Heart Failure Insulin Resistance Metformin Peak VO2

null

2

arm 1: Receiving Metformin for 4 months arm 2: Matched Placebo for 4 months

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Started at 500mg bd for 2 weeks. If well tolerated, increase to 1000mg bd for 14 weeks intervention 2: Similar dosing regime as active comparator

intervention 1: Metformin intervention 2: Matched Placebo (Capsules)

1

Dundee | Scotland | United Kingdom | -2.97489 | 56.46913

0

NCT00473876

[ 3 ]

2

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine the feasibility of treating relapsed follicular lymphoma with a combination of Bexxar and External Beam Radiotherapy (EBRT). Patients will receive EBRT (20 Gy in 10 fractions) followed by Bexxar.

Total dose delivered and tumor size are important predictors of local control in the treatment of low-grade Non-Hodgkin's Lymphoma (NHL). The basic principle is that larger nodal masses require increased doses of External Beam Radiotherapy (EBRT) to achieve local control. Radioimmunotherapy (RIT) seems to share this same characteristic. Review of the published literature on both Bexxar and Zevalin reveals that one of the most important predictors of treatment failure is nodal volume and its apparent relationship to dose delivered by RIT. The best tumor dosimetry for RIT is from Dr. Wiseman et al reporting on the dosimetry of Zevalin (PMID:11418315). He showed that tumors ≥15 cm\^3 received only 1082 cGy with Zevalin, whereas the average dose delivered in tumors \<15 cm\^3 was 4763 cGy. Recently, Gokhale et al (PMID:16111589) published their experience with Zevalin at Cleveland Clinic and showed a significant correlation with pretreatment tumor volume and response to therapy. In their experience, tumors ≥5 cm had an 83% rate of local recurrence versus 28% for tumors \<5 cm. This dosing paradox (bigger masses, which require more dose, receive less with RIT) may be diminished by the delivery of additional EBRT. This is the hypothesis that underlies the pilot study. The dosimetric data available for Bexxar is more heterogeneous but confirms the observations seen with Zevalin. In patients previously untreated for low-grade Non-Hodgkin's Lymphoma (NHL), Koral et al (PMID:12621015) showed an increased likelihood of achieving a complete response (CR) if tumor doses were \>650 cGy. Previous work by these same authors showed a trend for larger tumor volumes receiving less dose (PMID:10994741). The most compelling data for this relationship comes from the clinical trials done using Bexxar. Both in the pivotal trial (PMID:11579112) and the recently published trial treating naïve patients (PMID:15689582), tumor volume was a significant predictor of response to Bexxar. In the pivotal trial, smaller tumor burden was the only factor predicting longer duration of response. Whereas EBRT might be able to provide reliable radiation dose, the use of Bexxar may provide the therapeutic equivalent of central lymphatic irradiation, which would permit the use of true involved field radiotherapy. Investigators have previously noted that increased EBRT field size is associated with increased short-term and long-term toxicity. The toxicities associated with the treatment of radiotherapy are related to the site treated, but do not necessarily include the dose limiting toxicity of Bexxar, which is primarily hematologic and transient. As the toxicity of RT and Bexxar may not overlap, the combination of both may allow an increase in the therapeutic window for both radiotherapy and Bexxar therapy.

Non-Hodgkin's Lymphoma Follicular Lymphoma

null

0

null

2

[ 0, 3 ]

intervention 1: Patients will be treated in two dosing phases, each phase includes two infusions. The first phase, termed "dosimetric dose," involves an intravenous administration of 450 mg unlabeled tositumomab followed by an intravenous administration of 5 mCi (0.18 GBq) of I-131 tositumomab for the purpose of determining the rate of whole body clearance of radioactivity (residence time) so that the administered activity (mCi or GBq) to deliver a 75 cGy (or 65 cGy for patients with baseline platelet count from 100,000 to 149,999/mm\^3) total body radiation dose can be calculated. intervention 2: All patients are to receive 20 Gy in 10 fractions of 200 cGy to the PTV

intervention 1: Iodine I -01 Tositumomab (Bexxar) intervention 2: External Beam Radiation Therapy

1

Gainesville | Florida | United States | -82.32483 | 29.65163

0

NCT00475332

[ 3 ]

49

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.

null

Chronic Urticaria

Chronic urticaria, omalizumab, thyroperoxidase, IgE

null

2

arm 1: Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose. arm 2: Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.

[ 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection. intervention 2: Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection. intervention 3: All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines. intervention 4: All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.

intervention 1: Omalizumab 75-375 mg intervention 2: Placebo to omalizumab intervention 3: Loratadine intervention 4: Clemastine

11

Berlin | N/A | Germany | 13.41053 | 52.52437 Bonn | N/A | Germany | 7.09549 | 50.73438 Cologne | N/A | Germany | 6.95 | 50.93333 Dresden | N/A | Germany | 13.73832 | 51.05089 Giessen | N/A | Germany | 8.67554 | 50.58727 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanover | N/A | Germany | 9.73322 | 52.37052 Leipzig | N/A | Germany | 12.37129 | 51.33962 Lübeck | N/A | Germany | 10.68729 | 53.86893 Mainz | N/A | Germany | 8.2791 | 49.98419 Munich | N/A | Germany | 11.57549 | 48.13743

0

NCT00481676

[ 3 ]

12

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving lenalidomide together with sunitinib and low doses of cyclophosphamide once a day may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving lenalidomide together with sunitinib and cyclophosphamide works in treating patients with stage IV eye melanoma.

OBJECTIVES: Primary * Determine the response rate in patients with stage IV ocular melanoma treated with lenalidomide, sunitinib malate, and low-dose metronomic cyclophosphamide. Secondary * Determine the toxicity of this regimen in these patients. * Determine the progression-free survival of patients treated with this regimen. * Obtain blood, urine, and tissue samples from these patients, when easily accessible, to determine the effects of this regimen on pathways thought to have been modulated by this regimen in pre-clinical studies. OUTLINE: This is nonrandomized, uncontrolled, open-label study. Patients receive oral lenalidomide, oral sunitinib malate\*, and oral low-dose cyclophosphamide once daily on days 1-28. Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. NOTE: \*Some patients will not receive sunitinib malate during course 1. After completion of study treatment, patients are followed every 3 months for 2 years, every 4 months for 3 years and then annually thereafter.

Intraocular Melanoma Malignant Conjunctival Neoplasm

recurrent intraocular melanoma metastatic intraocular melanoma ciliary body and choroid melanoma, medium/large size extraocular extension melanoma iris melanoma conjunctival melanoma

null

2

arm 1: Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD). arm 2: 2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 25-50 mg by mouth once daily on days 1-28. intervention 2: 10 mg by mouth once daily on days 1-28. intervention 3: 12.5 - 25 mg by mouth once daily on days 1-28.

intervention 1: cyclophosphamide intervention 2: lenalidomide intervention 3: sunitinib malate

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00482911

[ 3 ]

295

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses and patch sizes).

null

Restless Legs Syndrome

Rotigotine Neupro®

null

1

arm 1: Rotigotine trans-dermal patch

[ 0 ]

1

[ 0 ]

intervention 1: Rotigotine transdermal patches once daily: 2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)

intervention 1: Rotigotine

24

Innsbruck | N/A | Austria | 11.39454 | 47.26266 Bamberg | N/A | Germany | 10.90067 | 49.89873 Berlin | N/A | Germany | 13.41053 | 52.52437 Bielefeld | N/A | Germany | 8.53333 | 52.03333 Gelsenkirchen | N/A | Germany | 7.09654 | 51.50508 Gera | N/A | Germany | 12.08187 | 50.88029 Halle | N/A | Germany | 11.97947 | 51.48158 Jena | N/A | Germany | 11.5899 | 50.92878 Kassel | N/A | Germany | 9.5 | 51.31667 Köthen | N/A | Germany | 11.97093 | 51.75185 Marburg | N/A | Germany | 8.77069 | 50.80904 Mittweida | N/A | Germany | 12.97537 | 50.98622 München | N/A | Germany | 13.31243 | 51.60698 Neubrandenburg | N/A | Germany | 13.27532 | 53.56414 Oldenburg | N/A | Germany | 8.21467 | 53.14118 Regensburg | N/A | Germany | 12.10161 | 49.01513 Schwalmstadt-Treysa | N/A | Germany | N/A | N/A Schwerin | N/A | Germany | 11.41316 | 53.62937 Tuttlingen | N/A | Germany | 8.8177 | 47.98464 Ulm | N/A | Germany | 9.99155 | 48.39841 Unterhaching | N/A | Germany | 11.61564 | 48.06598 Alzira | Valencia | Spain | -0.43333 | 39.15 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165

0

NCT00498186

[ 3 ]

64

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following: * The safety and tolerability of multiple doses of INT 747; * The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis; * Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and; * Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.

This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks. The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.

Diabetes Mellitus, Type II Fatty Liver

Farnesoid X receptor agonist Metabolic Disorder Diabetes NAFLD

null

3

arm 1: None arm 2: None arm 3: None

[ 1, 1, 2 ]

2

[ 0, 0 ]

intervention 1: 25 mg by mouth once daily, 50 mg by mouth once daily intervention 2: Placebo

intervention 1: INT-747 intervention 2: Placebo

4

0

NCT00501592

[ 5 ]

53

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

1FEMALE

false

The purpose of this study is to evaluate the changes in bone structure as determined by magnetic resonance imaging measurements among early postmenopausal women after 24 months of treatment with alendronate, 70 mg once a week as compared to placebo

This is a randomized, double-blind, 24-month study. Fifty-five postmenopausal women, age range of 45-65 years, with low bone density will be recruited, with half of the subjects receiving alendronate + 2800 IU of vitamin D once weekly, the other half receiving placebo + 2800 IU of vitamin D once weekly. All study subjects will receive supplemental calcium 1000 mg/day + Vitamin D 400 IU/day. Measurements of microarchitecture will be made in the wrist, ankle, and hip, and the changes in trabecular bone will be assessed at 0, 12 and 24 months. Markers of bone turnover and bone mineral density (BMD) will be used to characterize the cohort and postmenopausal changes in bone turnover and density.

Osteopenia Osteoporosis

null

2

arm 1: alendronate sodium 70 mg tablet once a week for 24 months arm 2: placebo to match alendronate sodium

[ 1, 2 ]

2

[ 0, 10 ]

intervention 1: alendronate sodium 70 mg tablet once week for 24 months intervention 2: placebo to match alendronate sodium one tablet once a week for 24 months

intervention 1: alendronate sodium intervention 2: placebo comparator

1

San Francisco | California | United States | -122.41942 | 37.77493

0

NCT00504166

[ 3 ]

63

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The TURNS is a NIMH-funded contract for the evaluation of new compounds for the treatment of cognitive impairments in schizophrenia (HHSN 27820044 1003C; P.I.: Steve Marder, M.D.). Despite advances in the safety, tolerability, and effectiveness of antipsychotic medications for the treatment of schizophrenia, many patients continue to be plagued by impairments in social and work functioning. Persons with schizophrenia commonly show deficits in a number of areas of cognition that include impairments in attention, memory, and executive functioning (the ability and organize one's behavior). Importantly, a large body of literature now shows a link between cognition and community functioning in schizophrenia. It is believed that treatments that improve cognitive deficits may lead to improvements in work and social functioning. One approach to improve the community functioning of patients with schizophrenia is to develop new agents that treat the cognitive deficits of the illness. A promising agent is called AL-108. This drug is administered as a nasal spray. Studies in animals suggest that this drug may protect neurons and may improve cognition in schizophrenia. The current study is a twelve-week multicenter, double-blind, randomized clinical trial of two doses of AL-108 (5 and 30 mg/day intranasally) versus placebo in the treatment of persistent cognitive dysfunction in schizophrenia. The study medication will be added to patients' current atypical antipsychotic medication or to their current injectable first-generation antipsychotic medication. The primary outcome measure will consist of the composite score of the MATRICS neuropsychological battery. Secondary outcome measures will include scores on symptoms, functional outcome, and safety measures. Sixty clinically stable patients with schizophrenia, drawn from eight sites, will participate in the study. Twenty-five patients will be enrolled at UCLA.

Background AL-108 is an intranasal drug product containing NAP, an 8 amino-acid peptide (Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln; NAPVSIPQ, MW=824.9) fragment of the much larger (approx. 124KD) Activity-Dependent Neuroprotective Protein (ADNP), which participates in neurodevelopment and neuroprotection. In mice, ADNP knockouts are lethal exhibiting CNS dysgenesis. ADNP mediates its effects in part through interaction with microtubules. Because of its large size, ADNP is assumed to not penetrate the BBB and thus cannot be used pharmacologically. NAP was chosen because it represents the epitope most associated with microtubule interaction and neuroprotection. NAP is absorbed following IV or intranasal administration, and has been shown to cross the BBB. Rationale for NAP treatment: tubulin function in brain function The cytoskeleton plays a key role in maintaining the highly asymmetrical shape and structural polarity of neurons that are essential for neuronal physiology. The cytoskeleton is made up of microfilaments, intermediate filaments and microtubules. Microfilaments (4-9 nm diameter) are made up of actin monomers and they function mainly to provide mechanical support and locomotion to the cell. Intermediate filaments are cytoplasmic fibers of \~10nm diameter. They provide supporting framework within the cell. Microtubules (\~24nm diameter) consist of tubulin and microtubule associate proteins. They function to transport nutrients and chemical messengers along the cell. Neurofibrillary tangles are twisted bundles of neurofibrils formed when the microtubule-associated protein, tau, dissociates from microtubules and clusters to form an insoluble mass. Under normal conditions tau binds to microtubules, stabilizing neuronal structure and integrity. Hyperphosphorylation of tau is assumed to be the cause for the formation of neurofibrillary tangles. Although neurofibrillary tangles are most associated with cognitive dysfunction in Alzheimers disease, some increase in neurofibrillary pathology has also been reported in schizophrenia, potentially as consequence of antipsychotic medication (1). Thus, mechanisms underlying microtubular function may be relevant to schizophrenia as well. In association with tubulin polymerization into microtubules, NAP influences tau dynamics by increasing the ratio of non-phosphorylated tau to phosphorylated tau, implying a dynamic process of cellular maintenance of the microtubular network, which is essential for the survival of the cell. In brain, tubulin frameworks are stabilized by recently described STOP proteins (2) (aka MAP6). Linkages to allelic variation in STOP genes has been reported in schizophrenia, along with altered STOP protein expression in some brain regions (3). STOP knockdown mice show disturbances in dopaminergic neurotransmission (4) along with deficits in PPI and hypermotility that were partially reversed with clozapine (5). Thus, neuropathological features of schizophrenia may be due, in part, to abnormal STOP-related stabilization of microtubular structure, and NAP may stabilize STOP-related abnormal neurophysiological processes in schizophrenia.

Schizophrenia

Cognition Schizophrenia

null

4

arm 1: AL-108, 30 mg/day- 3 sprays in each nostril, twice per day arm 2: AL-108, 5 mg/day- one spray in each nostril once per day arm 3: Placebo- 3 sprays in each nostril, twice per day arm 4: Placebo- one spray in each nostril, once per day

[ 0, 0, 2, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: AL-108, 5 mg/day- one spray in each nostril once per day intervention 2: AL-108, 30 mg/day- 3 sprays in each nostril, twice per day intervention 3: Placebo- 3 sprays in each nostril, twice per day intervention 4: Placebo- one spray in each nostril, once per day

intervention 1: AL-108 intervention 2: AL-108 intervention 3: Placebo intervention 4: Placebo

8

0

NCT00505765

[ 4 ]

92

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD. Subjects will experience two screening visits and one baseline visit. Those who meet admission criteria will enter the double-blind phase. This will involve two 4-week treatment periods one of which will involve the use of MTS and the other a placebo patch. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label MTS phase designed to assess long-term effects.

ADHD affects from 3 to 5% of children, persists into adolescence in 40 to 70% of these children and continues into adulthood in at least 50% of affected adolescents. Methylphenidate was the first medication shown to be effective in treatment for adults with ADHD and continues to be widely used. While the extended release formulations represent an improvement over the immediate release versions, significant problems remain for many patients. In particular, most have been designed with the goal of providing medication only during school hours and a short time period after school. In adults, there is a frequent need for much more extended duration of treatment. MTS is a new form of methylphenidate that provides medication in a transdermal patch delivery system. It has a very even, slowly ascending pharmacokinetic profile. MTS's very stable slowly increasing blood level should overcome the problems noted above with a delivery system that is more convenient for many patients. It is currently approved for treatment of childhood ADHD, with effectiveness and safety profiles similar to other forms of methylphenidate. This study will be the first to evaluate the effectiveness and safety of MTS in adult ADHD. This is a double-blind, placebo-controlled, randomized, crossover trial comparing MTS with placebo patch. The double-blind trial will be preceded by an enrollment period consisting of two screening visits followed as quickly as possible by a baseline visit. Patients who continue to meet admission criteria at baseline will be randomized into the first of two 4-week treatment periods. We will attempt to reach the highest tolerated dose size of MTS within 2 weeks and then observe the response over the last two weeks of each crossover phase. The double-blind period will be followed by a 180 day open-treatment, flexible-dose phase designed to assess long-term effects.

Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder ADHD Adult Methylphenidate Transdermal System Daytrana

null

2

arm 1: This arm was 4 weeks long. Subjects were treated using Methylphenidate Transdermal System. Patients were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone contact. MTS was initiated using a 12.5 cm patch. The dose was increased during the first 2 weeks based on treatment response and side effects to the largest tolerated dose/patch size. It was held steady the last 2 weeks. arm 2: This arm was 4 weeks long. Placebo patch was initiated using a 12.5 cm patch and then increased to the largest tolerated patch size during the first 2 weeks and held steady the last two weeks. Subjects were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone visit.

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: MTS is an advanced patch product that provides methylphenidate evenly mixed with the adhesive. This formulation allows good adhesion and a wide range of dose sizes. MTS patch sizes of 12.5, 18.75, 25 and 37.5cm2 are equivalent to nominal doses over a 9-hour wear time of 10, 15, 20 and 30mg of MPH. intervention 2: This patch is designed to appear identical to the actual intervention patch

intervention 1: Methylphenidate Transdermal System (MTS) intervention 2: placebo patch

1

Salt Lake City | Utah | United States | -111.89105 | 40.76078

0

NCT00506285

[ 3 ]

1

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Primary Objectives: 1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front phase II window in newly diagnosed or relapsed JMML. 1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic basis of Juvenile Myelomonocytic Leukemia (JMML) \[mutations in NF1, Ras, SHP2\] or levels of TNFa. 1.3 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and other cytokines by ELISA and bioassay and improves blood counts. 1.4 Estimate the two year event free survival and overall survival in JMML patients following etanercept and allogeneic hematopoietic stem cell transplantation.

Etanercept blocks a hormone called Tumor Necrosis Factor (TNF), which has been shown to play a role in helping the growth of leukemic cells in JMML. Before participants can start treatment on this study, they will have what are called "screening tests". These tests will help the doctor decide if patients are eligible to take part in the study. You will have a complete medical history and physical exam. About two tablespoons of blood and urine will be collected for routine tests as well as to test for the liver and kidney function. You will have a bone marrow biopsy performed to monitor disease activity. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle. You will have cells from inside of the mouth tested for genetic changes by swabbing the side of the cheeks. If you are found to be eligible, etanercept will be given as an injection under the skin once a week for up to 90 days. During the study, you will have weekly follow-up tests that will include physical exam and lab tests. About 2 tablespoons of blood will be collected each time. Urine will also be collected for testing at least every 3 weeks while on the study. If the disease gets worse or intolerable side effects occur, you will be taken off study and alternative treatment options will be discussed. This is an investigational study. The FDA has approved etanercept for use in adults and children with rheumatoid arthritis and juvenile rheumatoid arthritis. Its use in this study is experimental. A total of up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Leukemia

Juvenile Myelomonocytic Leukemia JMML Leukemia Etanercept Enbrel

null

1

arm 1: 0.8 mg/kg subcutaneously weekly for 90 days

[ 0 ]

1

[ 0 ]

intervention 1: 0.8 mg/kg Subcutaneously Once A Week for 90 Days

intervention 1: Etanercept

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00509600

[ 4 ]

467

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

null

Diabetes Diabetes Mellitus, Type 2

null

2

arm 1: Liraglutide 1.8 mg once daily + subject's own OAD treatment arm 2: Exenatide 10 mcg twice daily + subject's own OAD treatment

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1.8 mg once daily for s.c. (under the skin) injection. intervention 2: 10 mcg twice daily for s.c. (under the skin) injection.

intervention 1: liraglutide intervention 2: exenatide

125

0

NCT00518882

[ 5 ]

10

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to find out what parts of the brain have increased or decreased activity when people are depressed and how antidepressant medicine changes this activity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain

This study will measure the activity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with a standard antidepressant called duloxetine.

Major Depression

Depression Duloxetine fMRI pictures

null

1

arm 1: Open-label duloxetine 30 - 60 mg oral administration

[ 5 ]

1

[ 0 ]

intervention 1: 60 mg capsules

intervention 1: Duloxetine

1

Indianapolis | Indiana | United States | -86.15804 | 39.76838

0

NCT00532480

[ 5 ]

314

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20 mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria. Subjects with chronic urticaria who are currently taking a second generation antihistamine will be treated with desloratadine (5, 10, or 20 mg) for 28 days.

null

Chronic Idiopathic Urticaria

null

3

arm 1: 5-mg Desloratadine once daily arm 2: 10-mg Desloratadine once daily arm 3: 20-mg Desloratadine once daily

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 5-mg desloratadine tablets, once daily for four weeks. intervention 2: 10-mg desloratadine tablets, once daily for four weeks. intervention 3: 20-mg desloratadine tablets, once daily for four weeks.

intervention 1: 5-mg Desloratadine intervention 2: 10-mg Desloratadine intervention 3: 20-mg Desloratadine

0

null

0

NCT00536380

[ 4 ]

70

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study is meant to assess the effectiveness of idebenone on neurological outcome measures in patients with Friedreich's Ataxia over a 6 months period.

The study involves 6 clinic visits and upon completion the possibility to join a 12 months extension study where all patients will receive high dose Idebenone.

Friedreich's Ataxia

Friedreich's Ataxia Idebenone ICARS

null

3

arm 1: mid dose Idebenone arm 2: high dose Idebenone arm 3: Placebo

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients \> 45 kg/99 lbs: idebenone 900 mg/day intervention 2: Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients \> 45 kg/99 lbs: idebenone 2250 mg/day intervention 3: Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.

intervention 1: Idebenone intervention 2: Idebenone intervention 3: Placebo

2

0

NCT00537680

[ 3 ]

14

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.

Study 109609 is a single-arm, non-randomized, single-stage Phase II study of pazopanib in subjects with Stage IIIB or IV non-small cell lung cancer who have progressed after one or two prior regimens of systemic therapy. The study will be conducted at a limited number of institutions in the US. A total of 40 evaluable subjects will be enrolled and treated. Pazopanib will be given at a dose of 800mg (as determined by previous Phase I studies) orally once per day. Subjects may continue to receive study drug for up to two years unless they experience disease progression or withdraw from treatment for other reasons, or unless the Sponsor terminates the study. A rollover study may be available to those subjects who are exhibiting clinical benefit (stable disease or better). Evaluable subjects will be assessed for response as the primary endpoint.

Lung Cancer, Non-Small Cell

anti-angiogenesis Non-small cell lung cancer, pazopanib (GW786034)

null

1

arm 1: Single-arm, non-randomised, single-stage pazopanib monotherapy.

[ 0 ]

1

[ 0 ]

intervention 1: Pazopanib monotherapy

intervention 1: Pazopanib (GW786034)

13

0

NCT00549328

[ 5 ]

142

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study used two doses of rivastigmine transdermal patch (5 cm\^2, 10 cm\^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.

null

Alzheimer's Disease

Alzheimer's rivastigmine transdermal safety randomized switch patch

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months). intervention 2: Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment). intervention 3: Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.

intervention 1: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) intervention 2: Rivastigmine patch (9.5 mg/day) intervention 3: Rivastigmine capsules (6 mg to 12 mg/day)

1

Barcelona | N/A | Spain | 2.15899 | 41.38879

0

NCT00549601

[ 5 ]

18

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

1FEMALE

false

This randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy.

Infectious morbidity in gynecologic oncology has not been thoroughly investigated to date. Included in the literature are several studies that highlight substantial numbers of post-surgical infectious complications. Specifically among patients undergoing radical vulvectomy, the incidence of post-operative wound complication is as high as 58%. Surgery is the treatment of choice for vulvar cancer, but few studies establish protocols or management strategies to prevent the complications of post-operative wound infection and breakdown. This proposed randomized prospective study would specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy. This same regimen has been described by a leader in the field of gynecology in his text - TeLinde's Operative Gynecology. This study will utilize two arms - one as the treatment arm utilizing 24 hours of prophylactic antibiotics and the other as control.

Wound Infection

vulvectomy wound infection wound complication prophylactic antibiotic Post-operative wound complications following vulvectomy

null

2

arm 1: Participants received Cefazolin 2 grams intravenously within 30 minutes prior to incision arm 2: Participants received Cefazolin 2 gram intravenous within 30 minutes prior to incision and 1 gram Cefazolin every 8 hours for the first 24 hours post-op

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Cefazolin 1 gram IV every 8 hours for a total of 3 doses. Patients in both arms will receive an initial pre-operative 2 gram dose of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV q 8 hrs will be used. intervention 2: Patients in active comparator arm will receive an initial pre-operative 2 gram does of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV will be used.

intervention 1: Cefazolin PostOperatively intervention 2: Cefazolin Preoperatively

1

Canton | Ohio | United States | -81.37845 | 40.79895

0

NCT00550290

[ 4 ]

2,221

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

1FEMALE

true

The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.

null

Contraception

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Single dose intervention 2: Single dose

intervention 1: CDB-2914 intervention 2: Levonorgestrel

33

0

NCT00551616

[ 3 ]

253

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

false

This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory agent, will improve the clinical condition of patients with rheumatoid arthritis who still have active joint inflammation despite taking methotrexate for at least 6 months.

This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study in which patients with active RA despite receiving methotrexate for at least 6 months (at unchanged doses for \>=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 mg, or placebo given orally q12h for 12 weeks. Screening examinations will occur within 1 month prior to dosing. Washout of other disease-modifying antirheumatic drugs (DMARDs) (with the exception of hydroxychloroquine), including biological agents, will occur prior to dosing; if washout is necessary, patients must re-qualify for inclusion following the washout. Doses of nonsteroidal anti-inflammatory drugs (NSAIDS) and corticosteroids must be stable for \>=1 month prior to dosing and remain so during protocol participation. Disease activity will be assessed using swollen and tender joint counts, physician and patient global assessments (by visual analog scale, VAS), patient reported pain (by VAS), a Health Assessment Questionnaire (HAQ) Disability Index (DI), Westergren erythrocyte sedimentation rate (ESR, Screening, Weeks 0 and12), and C-reactive protein (CRP) levels. Assessments will take place at Screening, Baseline (Week 0), and at Weeks 2, 4, 8, and 12.

Rheumatoid Arthritis

null

3

arm 1: CF101 0.1 mg was given orally q12h arm 2: CF101 1 mg was given orally q12h arm 3: Matched placebo was given orally q12h

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: orally q12h intervention 2: orally q12h

intervention 1: CF101 intervention 2: Placebo

26

Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Stara Zagora | N/A | Bulgaria | 25.64194 | 42.43278 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Prague | N/A | Czechia | 14.42076 | 50.08804 Zlín | N/A | Czechia | 17.67065 | 49.22645 Afula | N/A | Israel | 35.2892 | 32.60907 Ashkelon | N/A | Israel | 34.57149 | 31.66926 Haifa | N/A | Israel | 34.99928 | 32.81303 Jerusalem | N/A | Israel | 35.21633 | 31.76904 Kfar Saba | N/A | Israel | 34.90694 | 32.175 Elblag | N/A | Poland | 19.40884 | 54.1522 Lublin | N/A | Poland | 22.56667 | 51.25 Sopot | N/A | Poland | 18.56003 | 54.4418 Szczecin | N/A | Poland | 14.55302 | 53.42894 Torun | N/A | Poland | 18.59814 | 53.01375 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Niška Banja | N/A | Serbia | 22.0057 | 43.29507 Donetsk | N/A | Ukraine | 37.80224 | 48.023 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Vinnycia | N/A | Ukraine | N/A | N/A

0

NCT00556894

[ 2 ]

2

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to explore the safety and efficacy of ranibizumab to treat non-arteritic ischemic optic neuropathy based on clinical and anatomical findings.

Nonarteritic anterior ischemic optic neuropathy (NAION) is the most common acute optic neuropathy in people older than 50 years. It is characterized by sudden partial loss of vision in one eye and has an increased risk of vision loss in the fellow eye. Although cause has not been determined, NAION is thought to occur following an idiopathic ischemic event involving the short posterior ciliary arteries that supply blood to the most anterior part of the optic nerve. A complete loss of vision is rare, but partial loss of visual field or acuity can result from NAION in the affected eye(s). Patients who have a 'disc at risk' or 'crowded disc' (small cup: disc ratio) are at increased risk for developing NAION. Other risk factors for NAION include age \> 50 years and white race (estimated 95% of cases). Hypertension and diabetes also predispose to NAION development. Other factors that have been associated with NAION include high cholesterol, arteriosclerosis, stroke, cardiac and intraocular surgery, tobacco use, nocturnal hypotension, blood loss, glaucoma, elevated homocysteine and sleep apnea. The association between NAION and hypertension, high cholesterol and diabetes is stronger in individuals younger than 50 years than in older persons. Patients with NAION caused by ischemia leading to swelling of the optic nerve and rapidly progressing visual loss have had limited results with therapy such as corticosteroids, brimonidine, levodopa or surgery, such as optic nerve sheath decompression, in the past. Currently, there is no standard of care for these patients. Although the role of vascular endothelial growth factor (VEGF) in NAION has not been established, ischemic conditions may lead to VEGF production which could be the cause of edema and swelling. This possibility suggests that VEGF may be a target for therapeutic intervention by ranibizumab. Ranibizumab has demonstrated an effect on edema and vascular permeability. In animal studies it has shown a concentration- dependent effect of blunting the vascular permeability induced by VEGF. Of the more than 5,000 subjects with age-related macular degeneration in current and completed clinical trials, vascular permeability and edema have decreased with the use of ranibizumab.

Nonarteritic Anterior Ischemic Optic Neuropathy

non-arteritic ischemic optic neuropathy ranibizumab naion

null

1

arm 1: To determine the mean change in best corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study testing system at 6 months in NAION patients treated as needed (PRN) with ranibizumab.

[ 0 ]

1

[ 0 ]

intervention 1: All patients (n=15) will be treated with open label 0.5mg ranibizumab given intravitreally monthly as needed for 6 months.

intervention 1: ranibizumab

1

Aurora | Colorado | United States | -104.83192 | 39.72943

0

NCT00561834

[ 3, 4 ]

6

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International; operational oversight was provided by ZymoGenetics.

null

Lupus Nephritis

nephritis atacicept

null

2

arm 1: None arm 2: None

[ 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Atacicept will be administered at a dose of 150 milligram (mg) subcutaneously (SC) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. intervention 2: MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion. intervention 3: Placebo will be administered at a dose of 150 mg SC twice weekly for 4 weeks followed by 150 mg SC once weekly for 48 weeks. intervention 4: High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.

intervention 1: Atacicept intervention 2: Mycophenolate mofetil intervention 3: Placebo intervention 4: Corticosteroids

20

0

NCT00573157

[ 3 ]

1

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to compare methadone with morphine in the management of moderate to severe cancer pain.

Treatment of cancer pain is based on the World Health Organization (WHO) step ladder approach to the use of analgesic drugs. Medication potency increases at each step of the WHO ladder, from nonopioid (step 1; e.g., aspirin and nonsteroidal anti-inflammatory drugs) through weak opioids (step 2; e.g. codeine) plus a nonopioid to strong opioids (step 3; e.g., morphine) plus a nonopioid analgesic. Morphine is considered the gold standard for the treatment of moderate to severe pain, but this is based on level C criteria. Research has discovered that methadone is a potent opioid that operates at several levels which are important for pain control. The primary aim is to compare morphine versus methadone as a first-line analgesic in patients with moderate to severe cancer pain. Patients will be randomized to receive either oral slow-release morphine (15 mg) every 8 hours and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain or oral methadone 2.5 mg every 8 hours and methadone 2.5 mg every 4 hours as needed for breakthrough pain. Our hypothesis is that methadone will provide equivalent pain control efficacy after 4 weeks of therapy. We postulate that methadone will be as preferable as morphine as an analgesic. We will compare the two drugs via adverse effects and compare stability of analgesia via comparison of the number of breakthrough pain episodes. The study will attempt to establish equivalency of methadone as a first-line analgesic for moderate to severe cancer pain.

Neoplasms Pain

Neoplasms Pain Methadone Morphine

null

2

arm 1: Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain. arm 2: Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain. intervention 2: Oral slow-release morphine 15 mg every 8 hours, and oral immediate-release morphine 10 mg every 4 hours as needed for breakthrough pain.

intervention 1: Methadone intervention 2: Morphine

1

Scottsdale | Arizona | United States | -111.89903 | 33.50921

0

NCT00573937

[ 3 ]

4

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study is being done in an attempt to improve the remission rate and the survival time for subjects with high-risk myeloma. It is hoped that by giving higher doses of commonly used chemotherapy drugs and by giving courses closer together (before the myeloma comes back or gets worse), subjects in this study will have better outcomes.

This study has the following goals: * To find out how many subjects treated with high dose DTPACE (Dexamethasone, Thalidomide, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide. (HD DTPACE) on this protocol will have a complete response or near complete response that lasts for 6 months or longer. * In subjects achieving a response, to find out how long the response will last. * To learn more about the side effects of this treatment. Up to 75 subjects, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at the University of Arkansas for Medical Sciences (UAMS) only. The treatment in this study is divided into 3 parts * High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored. * High dose DTPACE and stem cell re-infusion. * Velcade, Thalidomide, Dexamethasone (sometimes known as VTD) Maintenance therapy.

Multiple Myeloma

null

1

arm 1: DTPACE

[ 0 ]

1

[ 0 ]

intervention 1: * Dexamethasone 200 mg Intravenous Infusion "Piggy-Back" (IVPB) Days 1-7 * Thalidomide 200 mg by mouth (PO) Days 1-7 * Cisplatin 15mg/m2 Days 1-4 (modify for renal insufficiency) * Adriamycin 15 mg/m2 Days 1-4 * Cyclophosphamide 600 mg/m2 Days 1-4 * Etoposide 60 mg/m2 Days 1-4

intervention 1: DTPACE

1

Little Rock | Arkansas | United States | -92.28959 | 34.74648

0

NCT00577512

[ 0 ]

75

NON_RANDOMIZED

PARALLEL

7BASIC_SCIENCE

0NONE

true

0ALL

false

The purpose of the study is to investigate the functional state of dopamine cells and the dopamine transporter in ADHD subjects and controls to assess the effects of chronic methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD subjects.

null

Attention Deficit Hyperactivity Disorder

Brookhaven ADHD Dopamine methylphenidate PET

null

2

arm 1: intervention is methylphenidate once daily for 12 months, doses individually titrated arm 2: no methylphenidate treatment for non ADHD

[ 0, 4 ]

1

[ 0 ]

intervention 1: subjects received mehtylphenidate treatment for 12 months

intervention 1: Experimental: methylphenidate treatment

1

Irvine | California | United States | -117.82311 | 33.66946

0

NCT00580814

[ 3 ]

241

RANDOMIZED

FACTORIAL

1PREVENTION

0NONE

false

0ALL

true

The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.

null

Care, Postoperative Pain, Postoperative Surgical Procedures, Operative Otorhinolaryngologic Surgical Procedures Tonsillectomy Adenoidectomy

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 1, 1, 1, 1 ]

4

[ 5, 0, 5, 10 ]

intervention 1: This group will receive the standard preoperative visit to the hospital with Child Life intervention intervention 2: 0.5 mg/kg oral midazolam intervention 3: One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program. intervention 4: Subjects in this group will receive both interventions 2 and 3.

intervention 1: Preoperative Preparation Program (Child Life Specialist) intervention 2: Midazolam intervention 3: Parental Presence during Induction of Anesthesia intervention 4: PPIA preparation program PLUS Midazolam premedication

1

New Haven | Connecticut | United States | -72.92816 | 41.30815

0

NCT00581139

[ 3 ]

96

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this research study is:(1) to determine if high doses of chemotherapy without total body irradiation can allow selected stem cells to take and grow,(2) to determine if selected stem cells from the blood or marrow can take and not cause a complication called graft-versus-host disease (GvHD) and (3) to evaluate the side effects of the combination of chemotherapy drugs used for these transplants. In the last 10 years we have developed chemotherapy combinations to be used for this T-cell depleted transplant protocol. By using three chemotherapy drugs (IV busulfan, melphalan and fludarabine), we hope to have a good chemotherapy combination to kill cancer cells, and to make the graft take, without the side effects of total body irradiation. The chemotherapy drugs to be tested in this protocol are busulfan, melphalan and fludarabine, all of which have been used successfully for stem cell transplantation, but not given together as in this specific regimen. This is what is being tested in this study. Our initial trials in the 1980's with T-cell depleted transplants showed less GvHD, but the overall results of the transplants were not better. The reason for this was that the stem cells did not take and engraft in 15% of our adult patients. This failure of the stem cells to take can leave patients without bone marrow or blood cells necessary for life. Most stem cell transplants were done using bone marrow (BMA) obtained from the donors. However, if we give a medication called G-CSF by shots to the donor, we can collect peripheral blood stem cells (PBSC) and use them for transplant. The advantage of this approach is that we can collect 2-20 times more stem cells than that obtained from the marrow. It has been proven that a larger number of stem cells in the graft make it more difficult for the patient to reject the stem cells. Some donors may be too small to provide peripheral blood stem cells or they may not want to take G-CSF shots. In these cases the donors will have their marrow collected in the operating room under general anesthesia. Stem cell transplants can lead to a condition known as acute graft-versus-host disease or GvHD. This disease is caused by an assault by certain cells in the marrow or blood (T-cells) of the donor (graft) against your body (the host). These T-cells see your body as foreign and attack it. The disease causes a skin rash, liver disease, and diarrhea. Methods were developed at this institution to prevent GvHD. These methods take out most of the T-cells (responsible for GvHD) from the marrow or blood stem cells before transplant. This is called "T-cell depletion" or "stem cell selection". In this hospital, we use two types of methods of T-cell depletion: one method is used with peripheral blood stem cells and one for bone marrow. Both these techniques have been successful in preventing both acute and chronic GvHD. You will receive a T-cell depleted stem cell transplant.

The trial proposed is a single arm, phase II treatment protocol designed to examine the engraftment, toxicity, graft-versus-host disease and ultimate disease-free survival following transplants derived from (1) HLA-matched siblings or related donors, (2) HLA-compatible unrelated donors or (3) HLA haplo-type mismatched related donors using a new chemotherapeutic cytoreductive regimen. Candidates for transplant will be stratified according to their donor types. Candidates for this trial will include patients with high risk forms of ALL, AML or CML, non-Hodgkin's lymphoma, or myelodysplastic syndrome for whom an allogeneic marrow transplant is clearly indicated, and patients with aplastic anemia refractory to ATG or cyclosporine treatment and who are transfusion dependent. All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (Thymoglobulin®) prior to transplant to promote engraftment. No drug prophylaxis againstGvHD will be administered post transplant. All research participants will also receive G-CSF post-transplant to foster engraftment. The preferred source of stem cells will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 5-6 days. PBSC obtained through 2-3 leukaphereses will be Isolex® 300i separated CD34+ stem cell column selected and E-rosette depleted (E-). The CD34 + E peripheral blood progenitors will then be administered to the research participants after they have completed cytoreduction. If the use of CD34 + E- PBSC is not possible, the alternative graft will consist of bone marrow derived stem cells T-cell depleted by soybean agglutinin and E-rosetting (SBA-E-). Research participants will be carefully monitored for engraftment, chimerism, incidence and severity of acute and chronic GvHD, regimen-related toxicity, characteristics of hematopoietic and immune reconstitution and ultimate survival and disease-free survival. This phase II trial is designed to investigate the feasibility and safety of a chemotherapy-based cytoreductive regimen plus a T-cell depleted peripheral blood stem cell (PBSC) or bone marrow stem cell transplant (BMT) for the treatment of high risk patients with advanced stages of hematologic malignancies. The majority of research participants will receive grafts derived from PBSC and will be the focus of the trial. The study population will be segmented into three research participant groups based on the type of donors used for the hematopoietic stem cell graft: (1) HLA-identical sibling or related donor, (2) HLA-compatible unrelated donor, and (3) HLA-mismatched related donor. A maximum of 25 PBSC research participants in both related groups will be accrued onto the study; a maximum of 70 PBSC research participants in the unrelated group will be accrued. In order to reduce patient risk, the study design includes early termination of any trial group in the event of excessive graft failure, grade 3-4 acute graft-versus-host disease, or early transplant related mortality during the accrual period. Excessive failure is defined differently in the three donor groups. Stopping rules for the three research participant populations will be utilized. In addition to the 120 PBSC research participants, we anticipate approximately 25 BMT research participants treated across the three donor groups. These research participants will be followed and at the conclusion of the trial descriptive statistics on this subgroup will be recorded.

Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Allogeneic Marrow Transplant

Cancer Donors Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Lymphoma AML ALL CML Allogeneic marrow transplant Bone marrow transplant

null

3

arm 1: 25 research participants with HLA Identical Related Donor using PBSC, 6 with BMT arm 2: 70 research participants with HLA-Matched Unrelated Donor using PBSC, 17 with BMT arm 3: 25 research participants with HLA-Mismatched Related Donor using PBSC, no BMT

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment. The preferred source of stem cells will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 5-6 days. PBSC obtained through 2-3 leukaphereses will be Isolex® 300i separated CD34+ stem cell column selected and E-rosette depleted (E-). The CD34+Eperipheral blood progenitors will be administered to the research participants after they have completed cytoreduction. intervention 2: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (Thymoglobulin®) prior to transplant to promote engraftment. No drug prophylaxis against GvHD will be administered post transplant. All research participants will also receive G-CSF posttransplant to foster engraftment. The preferred source of stem cells will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 5-6 days. PBSC obtained through 2-3 leukaphereses will be Isolex® 300i separated CD34+ stem cell column selected and E-rosette depleted (E-). The CD34+Eperipheral blood progenitors will be administered to the research participants after they have completed cytoreduction. intervention 3: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (Thymoglobulin®) prior to transplant to promote engraftment. No drug prophylaxis against GvHD will be administered post transplant. All research participants will also receive G-CSF posttransplant to foster engraftment. The preferred source of stem cells will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 5-6 days. PBSC obtained through 2-3 leukaphereses will be Isolex® 300i separated CD34+ stem cell column selected and E-rosette depleted (E-). The CD34+Eperipheral blood progenitors will be administered to the research participants after they have completed cytoreduction.

intervention 1: BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF intervention 2: BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF intervention 3: BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00582933

[ 2 ]

9

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This purpose of this study is to evaluate the use of two medications, docetaxel and lovastatin to determine the highest dose of lovastatin and docetaxel that can be given safely as well as the safety of combining the two drugs and the effect on the subject's tumor. Subjects can have any cancer.

The primary objective of this study is to determine the maximum tolerated dose (MTD) of lovastatin and docetaxel in patients with various different cancers.

Any Cancer Breast Cancer

Any cancer Breast cancer Lovastatin Docetaxel

null

1

arm 1: Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Given PO intervention 2: Given IV

intervention 1: Lovastatin intervention 2: Docetaxel

1

Iowa City | Iowa | United States | -91.53017 | 41.66113

0

NCT00584012

[ 4 ]

413

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil compared to placebo, once daily (QD), in African-American participants with essential hypertension.

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. A major component of blood pressure regulation is the renin-angiotensin-aldosterone system, a system of hormone-mediated feedback interactions that results in the relaxation or constriction of blood vessels in response to various stimuli. Angiotensin II, a polypeptide hormone, is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme as part of the renin-angiotensin-aldosterone system. Angiotensin II is the principal pressor agent of the renin-angiotensin-aldosterone system with a myriad of effects on the cardiovascular system and on electrolyte homeostasis. In the United States, a disproportionate number of African-Americans have hypertension compared to age-matched non-Hispanic Caucasians and Mexican Americans. Earlier onset and greater severity of hypertension in African-Americans contribute to greater target organ damage and may be a factor in shorter life expectancy in this population compared to Caucasian-Americans. Although genetic factors have been invoked to explain these racial differences, environmental factors probably play a more important role. Improved management of hypertension through both lifestyle intervention and pharmacotherapy, including combination therapy, are necessary to achieve target blood pressure in African Americans. Takeda Global Research \& Development Center, Inc. is developing TAK-491 (azilsartan medoxomil) to treat patients with essential hypertension. Azilsartan medoxomil is a prodrug that is hydrolyzed to the active moiety, TAK-536 (azilsartan), which is a selective antagonist of the angiotensin II type 1 receptor subtype. This study is being conducted to evaluate the effectiveness and safety of oral azilsartan medoxomil compared with placebo in African-American participants with essential hypertension. Participation in this study is anticipated to be approximately 10 weeks.

Hypertension

Blood pressure blood pressure monitoring ambulatory Drug Therapy

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. intervention 2: Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. intervention 3: Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.

intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil intervention 3: Placebo

64

0

NCT00591253

[ 4 ]

566

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 amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine 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. A major component of blood pressure regulation is the renin-angiotensin-aldosterone system, a system of hormone-mediated feedback interactions that results in the relaxation or constriction of blood vessels in response to various stimuli. Angiotensin II, a polypeptide hormone, is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme as part of the renin-angiotensin-aldosterone system. Angiotensin II is the principal pressor agent of the renin-angiotensin-aldosterone system with a myriad of effects on the cardiovascular system and on electrolyte homeostasis. Takeda Global Research \& Development Center, Inc. is developing TAK-491 (azilsartan medoxomil) to treat patients with essential hypertension. Azilsartan medoxomil is a prodrug that is hydrolyzed to the active moiety, azilsartan, which is a selective antagonist of the angiotensin II type 1 receptor subtype. Amlodipine is a slow-channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. This study is being conducted to determine whether administration of azilsartan medoxomil in combination with amlodipine in participants with uncontrolled hypertension is more efficacious in reducing systolic blood pressure than amlodipine alone. Participation in this study is anticipated to be approximately 10 weeks.

Hypertension

Blood pressure blood pressure monitoring ambulatory Drug Therapy

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 and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. intervention 2: Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. intervention 3: Azilsartan medoxomil placebo-matching tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.

intervention 1: Azilsartan Medoxomil and amlodipine intervention 2: Azilsartan Medoxomil and amlodipine intervention 3: Amlodipine

50

0

NCT00591266

[ 3 ]

8

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The present protocol proposes study of the recently approved compound sodium oxybate (Xyrem), a gamma-aminobutyric acid type b (GABAB) and a g-hydroxybutyric acid (GHB) receptor agonist, for the study of persistent symptoms of schizophrenia. Sodium oxybate is a central nervous system depressant currently approved for treatment of narcolepsy associated with cataplexy and excessive daytime sleepiness. In addition to evaluating effects on sodium oxybate on persistent symptoms and neurocognitive deficits in schizophrenia, the study will test the hypothesis that this medication may be particularly effective in combating Insomnia Related to Schizophrenia, and in normalizing symptomatic and polysomnographic manifestations of sleep-related brain dysfunction in schizophrenia.

Rationale/Study Hypothesis: Rationale for study of sodium oxybate is twofold: first, sleep dysfunction is an important and overlooked aspect of schizophrenia intrinsically linked to cognitive and functional impairments, and, second, GABAB receptors regulate dopaminergic and glutamatergic systems in vivo, suggesting that GABAB agonists may be therapeutically beneficial in schizophrenia. We are aware of three previous trials of GHB in schizophrenia, two of which did not show any overall benefit in psychopathology. We noted multiple limitations in the controlled trials, including: 1. requirement of cumbersome dosing patterns (up to six times a day) that could have led to incomplete compliance, 2. lack of objective measures of subjective sleep or sleep architecture, 3. lack of objective cognitive testing, 4. use of GHB as monotherapy or only in conjunction with only low dose antipsychotics, 5. short trial duration (less than 4 weeks), 6. relatively low overall night-time dose of GHB, and 7. a heterogeneous, small sample. We propose an open label, proof of concept study evaluating the effect of sodium oxybate on insomnia in schizophrenia. The primary hypothesis of the study is that patients treated with sodium oxybate will show improved subjective sleep as measured by the overall Epworth Sleepiness Scale and the Pittsburgh Sleep Quality Index. Secondarily, we expect superior reduction in total psychopathology and PANSS factor scales (PANSS), polysomnographic measures, and neurocognition (MATRICS). Design and dosage schedule: We plan to enroll eight hospitalized patients with diagnostic \& statistical manual text revision (DSM-IV-TR) schizophrenia and insomnia related to schizophrenia. The study will include: a one-week evaluation period, which will include tapering of any hypnotics, baseline diagnostic, psychopathology, neurocognitive, electrophysiological and polysomnographic measurements. Patients will then begin a four-week trial of adjunctive sodium oxybate, with a three-week taper of sodium oxybate to follow. Hypnotic/sodium oxybate taper may be extended or abbreviated, depending on clinical judgment. Patients entering the study will be permitted to receive both typical and atypical antipsychotics. Treating psychiatrists will be encouraged to maintain fixed doses of all psychotropic medication throughout the study. Other than haloperidol and benztropine prn (up to 10 mg/day of haloperidol), the prescription of a new psychotropic will not be permitted. After the second week of study medication, any subject requiring more than 4 doses of haloperidol in one week will be considered to have relapsed, and will be withdrawn from the study.

Schizophrenia Insomnia Related to Schizophrenia (307.42)

Schizophrenia Sleep Architecture Sodium Oxybate Insomnia Cognition

null

1

arm 1: Active treatment

[ 0 ]

1

[ 0 ]

intervention 1: Patients will undergo a one-week evaluation period, which will include a taper and discontinuation of any currently prescribed sedative/hypnotics, as well as baseline diagnostic, psychopathology, neurocognitive and polysomnographic measurements (see below for details). Hypnotic taper may be extended or abbreviated, depending on clinical judgment. Patients will then begin a 4-week trial of adjunctive Xyrem (sodium oxybate). Patients will begin at 4.5 g/night (in divided doses of 2.25 g, with 1st dose at bedtime and then 2nd dose four hours later). Dosage will increase by 1.5 g/day every week, until a dose of 9 g nightly is reached, or a patient cannot tolerate further dose escalations. Medication will be administered in divided dosage for the duration of the study. A three-week taper (by 3 g/day weekly) of sodium oxybate will follow the four-week trial of sodium oxybate.

intervention 1: Sodium Oxybate

1

Orangeburg | New York | United States | -73.94958 | 41.04649

0

NCT00594256

[ 3 ]

3

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This is a phase II, multi-center, open-label, single-arm clinical trial to be conducted in the United States. In approximately 55 centers, approximately 75 eligible locally advanced unresectable or metastatic pancreatic cancer subjects will be enrolled to receive first-line therapy of gemcitabine and panitumumab.

Enrollment closed after 3 patients were enrolled. This voluntary action was prompted by the announcement that the Southwest Oncology Group (SWOG) S0205 trial (NCT00075686), A Phase III Randomized Open Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer, did not meet its primary endpoint of improving overall survival).

Cancer of Pancreas Cancer of the Pancreas Pancreas Cancer Pancreatic Cancer

null

1

arm 1: Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m\^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Intravenous administration intervention 2: Intravenous administration

intervention 1: Gemcitabine intervention 2: panitumumab

0

null

0

NCT00613730

[ 4 ]

613

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.

null

Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease COPD

null

3

arm 1: Formoterol 4.5 ug twice daily (bid) arm 2: Formoterol 9.0 ug bid arm 3: Placebo

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 4.5 mg inhaled twice daily intervention 2: 9 mg inhaled twice daily intervention 3: placebo inhaled twice daily

intervention 1: Formoterol Turbuhaler® 4.5mg intervention 2: Formoterol Turbuhaler® 9 mg intervention 3: Turbuhaler® placebo

47

0

NCT00628862

[ 2 ]

25

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

false

0ALL

null

A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.

Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached

Advanced Cancer Relapsed Advanced Cancer Refractory

null

2

arm 1: Arm A: Drug/Placebo arm 2: Arm B: Placebo/Drug

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity. intervention 2: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).

intervention 1: vorinostat intervention 2: Comparator: placebo (unspecified)

0

null

0

NCT00632931

[ 3 ]

7

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV

null

Osteosarcoma

osteosarcoma high dose methotrexate leucovorin

null

3

arm 1: HDMTX-LV with glucarpidase arm 2: HDMTX-LV with placebo arm 3: compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment

[ 0, 1, 0 ]

2

[ 0, 0 ]

intervention 1: IV dose based on weight, two doses given for 5 minutes, 24 hours apart intervention 2: IV or po given every 6 hours

intervention 1: glucarpidase intervention 2: leucovorin

0

null

0

NCT00634322

[ 5 ]

143

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to compare the effectiveness of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg maintenance with that of non-steroidal anti-inflammatory drugs (NSAIDs) maintenance in participants with knee osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) whose pain was relieved after the add-on treatment of tramadol hydrochloride to NSAIDs.

This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), comparative study to compare the efficacy of tramadol hydrochloride plus acetaminophen maintenance with that of NSAIDs maintenance in participants whose pain was relieved after the add-on treatment of tramadol 37.5 milligram (mg) plus acetaminophen 325 mg to NSAIDs. All participants will receive tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam \[7.5 mg or 15 mg once daily\] or aceclofenac \[100 mg twice daily\]) from Day 1 to Day 28, and participants will be randomly assigned into 2 treatment groups at Day 29 if the numerical rating scale score less than or equal 4. Tramadol plus acetaminophen group will receive 1 or 2 tablets containing tramadol 37.5 mg plus acetaminophen 325 mg 4 times daily (maximum daily dose will be 8 tablets) from Day 29 to Day 85 and NSAIDs group will receive either meloxicam 7.5 mg or 15 mg per day or aceclofenac 100 mg twice a day from Day 29 to Day 85. The efficacy will be evaluated on Day 1, Day 29, Day 57 and Day 85. The primary efficacy end point will be assessed through change in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) total score from Day 29 to Day 85. Participant's safety will be monitored throughout the study.

Osteoarthritis

WOMAC Knee osteoarthritis pain Pain intensity Tramadol Acetaminophen Meloxicam Aceclofenac

null

2

arm 1: Participants will receive fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who will have the numeric rating scale score 4 or less on Day 29 will be randomly assigned to the treatment of NSAIDs to receive either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85. arm 2: Participants will receive fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who will have the numerical rating scale score 4 or less on Day 29 will be randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose will be 8 tablets).

[ 1, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Meloxicam 7.5 mg or 15 mg per day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and meloxicam 7.5 mg or 15 mg per day from Day 29 to Day 85. intervention 2: Aceclofenac 100 mg twice a day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and aceclofenac 100 mg twice a day from Day 29 to Day 85. intervention 3: Fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam \[7.5 mg or 15 mg once daily\] or aceclofenac \[100 mg twice daily\]) from Day 1 to Day 28, and fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose will be 8 tablets).

intervention 1: Meloxicam intervention 2: Aceclofenac intervention 3: Tramadol Hydrochloride Plus Acetaminophen

0

null

0

NCT00635349

[ 3 ]

158

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine whether RX-1741, an oxazolidinone antibiotic, is safe and effective in the treatment of mild to moderate community acquired pneumonia (CAP).

null

Community-Acquired Pneumonia (CAP)

null

3

arm 1: Radezolid 300 mg arm 2: Radezolid 450 mg arm 3: Radezolid 450 mg BID

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 300 mg/day, orally for 7-10 days intervention 2: 450 mg/day orally for 7-10 days intervention 3: 900 mg/day orally for 7-10 days

intervention 1: Radezolid intervention 2: Radezolid intervention 3: Radezolid

30

0

NCT00640926

[ 4 ]

462

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients will participate in this study.

This is a prospective randomized (study medication is assigned by change) open-label, parallel-group, multicenter, 6 month study to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia using the ratio of the concentration of lipids (triglycerides) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) as the primary parameter. Secondary objectives include evaluation of additional parameters related to the total of the actions of the body to keep it alive (metabolic endpoints) and demonstration of non-inferiority of paliperidone ER versus olanzapine in efficacy as measured by Positive and Negative Syndrome Scale (PANSS). Patients previously treated with any oral antipsychotic, except those treated with paliperidone ER, olanzapine or clozapine during the last 6 months, can be enrolled and will be treated with paliperidone ER (6 to 9 mg/day) or olanzapine (10 to 15 mg/day). Patients will be divided into groups according to the metabolic effects of their previous antipsychotic medication (medication that does not increase body weight vs. medication that increases body weight). Throughout the study flexible dosing is allowed based on the investigator discretion. A study treatment period of 6 months is planned for all patients. Medication to treat symptoms like confusion, blurred vision, constipation, dry mouth, light-headedness, difficulty starting and continuing to urinate, and loss of bladder control may continue up to four weeks and should then be tapered off at the discretion of the investigator. Approximately 456 adult patients (228 in each treatment group) will participate in this study. Efficacy will be assessed with the following measures: PANSS (total score and subscale scores), Clinical Global Impression - Severity (CGI-S), Self-rated health status Survey SF-36, and Sleep and daytime drowsiness evaluation scale. The parameters related to the total of the actions of the body to keep it alive (metabolic endpoints) will be assessed with the following: ratio of blood lipids to blood good cholesterol concentrations (TG:HDL ratio) (for this primary evaluation, plasma fasting lipids and good cholesterol concentrations will be measured), fasting plasma insulin and fasting plasma glucose, plasma glucose and insulin concentrations before and after a 75 gram oral glucose tolerance test (OGTT) to asses insulin sensitivity and changes in insulin secretion, fasting good cholesterol, lipids, and glucose levels for the determination of new onset or presence of metabolic syndrome during treatment according to criteria of the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP/ATPIII criteria), weight, Body-Mass-Index and waist circumference for the determination of new onset or presence of a medical condition associated with abdominal obesity, abnormalities in glucose, lipid and cholesterol metabolism, and elevated blood pressure that increases the risk of cardiovascular disease and type 2 diabetes (metabolic syndrome) during treatment according to NCEP/ATP III criteria. All patients who receive trial medication (paliperidone ER or olanzapine) at least once will be included in the analysis of the demographic and baseline characteristic data. 2 dosage levels of paliperidone ER (6 or 9mg per day) and 2 of olanzapine (10 and 15mg per day) are available to the patients. Throughout the study flexible dosing is allowed based on the investigator's discretion. Study medication is to be taken in the morning orally, with water. A study treatment period of 6 months is planned for all patients.

Schizophrenia

Paliperidone ER Olanzapine Schizophrenia

null

2

arm 1: paliperidone ER 6-mg or 9-mg tablet once daily flexible dosing for 6 months arm 2: olanzapine 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months intervention 2: 6-mg or 9-mg tablet once daily flexible dosing for 6 months

intervention 1: olanzapine intervention 2: paliperidone ER

46

Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Córdoba | N/A | Argentina | -64.18853 | -31.40648 Mendoza | N/A | Argentina | -68.84582 | -32.88946 Alexandria | N/A | Egypt | 29.91582 | 31.20176 Cairo | N/A | Egypt | 31.24967 | 30.06263 El Banfaig 2 District | N/A | Egypt | N/A | N/A Pärnu | N/A | Estonia | 24.49711 | 58.38588 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Tartu | N/A | Estonia | 26.72509 | 58.38062 Allonnes | N/A | France | 0.16023 | 47.96744 Bron | N/A | France | 4.91303 | 45.73865 Dijon | N/A | France | 5.01667 | 47.31667 Limoges | N/A | France | 1.24759 | 45.83362 Montberon | N/A | France | 1.4801 | 43.71602 Athens | N/A | Greece | 23.72784 | 37.98376 Amman | N/A | Jordan | 35.94503 | 31.95522 Jelgava | N/A | Latvia | 23.71278 | 56.65 Liepāja | N/A | Latvia | 21.01085 | 56.50474 Riga | N/A | Latvia | 24.10589 | 56.946 Sigulda | N/A | Latvia | 24.85953 | 57.15375 Strenči | N/A | Latvia | 25.68535 | 57.62574 Beirut | N/A | Lebanon | 35.50157 | 33.89332 Kaunas | N/A | Lithuania | 23.90961 | 54.90272 Vilnius | N/A | Lithuania | 25.2798 | 54.68916 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Craiova | N/A | Romania | 23.8 | 44.31667 Oradea | N/A | Romania | 21.91833 | 47.0458 Sibiu | N/A | Romania | 24.15 | 45.8 Tg Mures | N/A | Romania | N/A | N/A Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Michalovce | N/A | Slovakia | 21.9195 | 48.75434 Rimavská Sobota | N/A | Slovakia | 20.02239 | 48.38284 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 A Coruña | N/A | Spain | -8.396 | 43.37135 Alicante | N/A | Spain | -0.48149 | 38.34517 Barcelona | N/A | Spain | 2.15899 | 41.38879 Elche | N/A | Spain | -0.70107 | 38.26218 Madrid | N/A | Spain | -3.70256 | 40.4165 Santander | N/A | Spain | -3.80444 | 43.46472 Vic | N/A | Spain | 2.25486 | 41.93012 Zamora | N/A | Spain | -5.74456 | 41.50633 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Bursa | N/A | Turkey (Türkiye) | 29.06013 | 40.19559 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Manisa | N/A | Turkey (Türkiye) | 27.42647 | 38.61202

0

NCT00645099

[ 4 ]

420

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.

The objective of this study is to demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo as measured by ACR20 response criteria following 12 weeks of therapy. The study is also designed to demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab eow as measured by ACR20 response criteria at Week 12.

Rheumatoid Arthritis

null

3

arm 1: Placebo 12 weeks, 40mg adalimumab remaining 12 weeks arm 2: 40 mg every other week arm 3: 80 mg monthly

[ 2, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Pre-filled syringe. See arm for more detail intervention 2: Pre-filled syringe. See arm for more detail intervention 3: Pre-filled syringe. See arm for more detail

intervention 1: adalimumab intervention 2: Placebo intervention 3: adalimumab

86

0

NCT00647270

[ 4 ]

55

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued.

This study includes a Prestudy Period; a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for females); a follow-up period where subjects will be observed every 6 months until physical and laboratory observations are at pubertal levels, then every 12 months for 5 years; lastly a final follow-up questionnaire is given to all subjects when they are at least 18 years old. At the treatment visits, efficacy assessments are Tanner staging (suppression of breast development in females and genital development in males), gonadotropins (LH and FSH), sex steroids (estradiol in females and testosterone in males), ratio of bone age to chronological age, adult height compared to a standard population and predicted mature height, and age and time to regular menses in females. This protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies.

Puberty, Precocious

CPP central precocious puberty pediatrics suppression of LH Lupron leuprolide acetate depot formulation GnRHa GnRH agonist GNRH analog LH Tanner staging

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.

intervention 1: Lupron (leuprolide acetate)

9

0

NCT00660010

[ 4 ]

36

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

2MALE

true

Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-4), and has been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes mainly through incretin hormone-mediated improvements in islet function. Although clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-4 inhibitor treatment, animal studies suggested that DPP-4 inhibition reduce intestinal triglyceride (TG) absorption and apolipoprotein production and increased chylomicron catabolism. Therefore, the present study was designed to examine the effects of sitagliptin on postprandial lipemia in patients with type 2 diabetes. A possible reduction in postprandial atherogenic triglyceride-rich lipoproteins (TRL) levels by sitagliptin would add to therapeutic utility of this DPP-4 inhibitor and suggest the potential to reduce cardiovascular risk in patients with type 2 diabetes.

null

Diabetes Mellitus Postprandial Lipemia

Diabetes mellitus Postprandial Hyperlipidemia Atherosclerosis

null

2

arm 1: Sitagliptin 100 mg/d for 6 weeks arm 2: Placebo for 6 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Sitagliptin 100 mg/d for 6 weeks intervention 2: Placebo for 6 weeks

intervention 1: Sitagliptin intervention 2: Placebo

1

Québec | Quebec | Canada | -71.21454 | 46.81228

0

NCT00660075

[ 4 ]

44

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.

At Visit 1, the dentist will: * do an oral exam * ask some questions * decide if the person qualifies for being in the study * make an appointment for Visit 2 if they qualify At Visit 2 (Baseline), the dentist will: * do a special cleaning of the implants * examine the whole mouth * collect some fluid * take x-rays * put the people into one of two groups (taking into account whether or not they smoke) 1. one group will have the study antibiotic put on all the areas in their mouth with gum problems 2. the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected. At Visit 4 (about 3 months later), the dentist will: * collect fluid samples * examine the whole mouth * apply the antibiotic again for people in that group At Visit 5 (about 6 months later), the dentist will: * collect fluid samples * examine the whole mouth * take x-rays

Periodontitis

Peri-implantitis; antibiotic

null

2

arm 1: 1 mg microspheres of minocycline hydrochloride arm 2: Control group receiving no drug intervention

[ 0, 4 ]

1

[ 0 ]

intervention 1: 1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial

intervention 1: Minocycline HCl

4

0

NCT00662532

[ 5 ]

8

NON_RANDOMIZED

SINGLE_GROUP

null

0NONE

false

0ALL

false

Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.

Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.

Critically Ill Hemodialysis

daptomycin pharmacokinetics renal replacement therapy critical illness intensive care units

null

0

null

1

[ 0 ]

intervention 1: Daptomcyin 8 mg/kg infused intravenously every 48 hours

intervention 1: Daptomycin

1

Ann Arbor | Michigan | United States | -83.74088 | 42.27756

0

NCT00663403

[ 2 ]

99

NON_RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography \[PET\] scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy. Screening consists of a Fluorodeoxyglucose Positron Emission Tomography \[FDG-PET\] and tumor imaging, medical history, physical examination, Eastern Cooperative Oncology Group \[ECOG\] performance status, blood draws, a pregnancy test for female patients of childbearing potential. Treatment consists of PF00562271 tablets continued until progression of disease, unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for biomarkers related to FAK and PYK2 kinase activities.

null

Head and Neck Neoplasm Prostatic Neoplasm Pancreatic Neoplasm

Pancreatic Neoplasm Head and Neck neoplasm Prostatic neoplasms; Focal Adhesion Kinase Phase 1 Pharmacodynamics FDG-PET

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 125 mg twice daily \[BID\] with food, tablet intervention 2: 125 mg BID with food, tablet intervention 3: 125 mg BID with food, tablet intervention 4: 125 mg BID with food, tablet

intervention 1: PF00562271 intervention 2: PF00562271 intervention 3: PF00562271 intervention 4: PF00562271

4

0

NCT00666926

[ 5 ]

293

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.

null

Diabetes Diabetes Mellitus, Type 2

null

1

arm 1: Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily

[ 0 ]

2

[ 0, 0 ]

intervention 1: Subcutaneous (under the skin) injection, twice daily intervention 2: Tablets, 1000 - 2000 mg daily

intervention 1: biphasic insulin aspart 30 intervention 2: metformin

1

Beijing | Beijing Municipality | China | 116.39723 | 39.9075

0

NCT00669864

[ 4 ]

458

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to investigate the occurence and the time to relapse and occurence of rebound after discontinuation of the investigational products. Only subjects with "controlled disease" will be considered for this observation phase of the study. "Controlled disease" is defined as "Clear" or "Almost Clear" severity category based on Investigator's global assessment (IGA).

null

Psoriasis Vulgaris

null

3

arm 1: None arm 2: None arm 3: None

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Once daily application intervention 2: Once daily application intervention 3: Once daily application

intervention 1: calcipotriol and betamethasone (LEO 80185 gel) intervention 2: LEO 80185 vehicle intervention 3: Tacalcitol ointment

1

Halifax | Nova Scotia | Canada | -63.57688 | 44.64269

0

NCT00670241

[ 2, 3 ]

9

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer

null

Colorectal Cancer

Colorectal Neoplasms Colorectal Tumors Colorectal Carcinoma

null

2

arm 1: Zalutumumab in combination with Irinotecan arm 2: Zalutumumab in combination with Irinotecan

[ 0, 0 ]

1

[ 0 ]

intervention 1: Solution for infusion

intervention 1: Zalutumumab

3

Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045

0

NCT00677924

[ 5 ]

75

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

false

The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal function and at high risk for Invasive Fungal Infection.

null

Fungal Infection Acute Myelogenous Leukemia Neutropenia

Antifungal Agents Anti-Infective Agents

null

3

arm 1: POS 200 mg three times a day (TID) on Days 1-8 followed by continued randomized dosing regimen of POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements. arm 2: POS 200 mg TID on Days 1-8 followed by randomized dosing regimen of POS 400 mg twice a day (BID) on Days 9-15, administered with food or oral nutritional supplements. arm 3: POS 200 mg TID on Days 1-8 followed by randomized dosing regimen of POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements.

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: Posaconazole will be used for prophylaxis

intervention 1: Posaconazole

0

null

0

NCT00686543

[ 2, 3 ]

2

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving clofarabine together with rituximab may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with rituximab and to see how well they work in treating patients with relapsed B-cell non-Hodgkin lymphoma.

OBJECTIVES: Primary * To determine the maximum tolerated dose of clofarabine in adult patients with relapsed CD20-positive B-cell non-Hodgkin lymphoma (NHL). * To estimate objective response rates of clofarabine in combination with rituximab in these patients. Secondary * To determine the 1-year progression-free survival of this regimen using the mean tolerated dose in these patients. * To determine the safety and efficacy of this regimen in these patients. * To determine if clofarabine acts as an inhibitor of DNA methylation similar to cladribine by performing scientific correlates. * To determine whether response to clofarabine alone or in combination with rituximab correlates with changes in global serum DNA methylation index. * To identify the gene activated by clofarabine therapy by using genomic DNA and RNA array technology. OUTLINE: This is a phase I, dose-escalation study of clofarabine followed by a phase II study. Patients receive oral clofarabine once daily on days 1-14 of all courses and rituximab IV on days 1, 8, 15, and 22 of course one and then on day 1 of courses 2-8. Courses repeat every 4 weeks. After 2 courses of therapy, patients who are eligible for stem cell transplantation may either undergo transplantation or continue receiving study drugs until disease progression or unacceptable toxicity for up to a total of 8 courses of treatment. Patients undergo blood sample collection periodically for correlative studies. Samples are analyzed to identify global DNA methylation differences and correlate changes in methylation index (MI) with patient outcome after treatment with clofarabine with or without rituximab via high performance liquid chromatography (HPLC); to determine differences in gene expression via microarray analysis and micro-RNA (miRNA) expression via quantitative polymerase chain reaction (PCR) in patients with high compared to low global DNA methylation index and miRNA expression for CD5+ B-lymphocytes obtained from pediatric tonsils and from B-lymphocytes of 5 healthy controls; and to determine gene expression and miRNA profiles in patients before and after treatment with clofarabine with or without rituximab via genomic DNA arrays. After completion of study treatment, patients are followed once a year for 2 years.

Lymphoma

extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult grade III lymphomatoid granulomatosis recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma cutaneous B-cell non-Hodgkin lymphoma

null

1

arm 1: Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off). Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg Phase II: Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV

[ 0 ]

8

[ 2, 0, 6, 6, 6, 6, 10, 10 ]

intervention 1: Administered weekly times 4 weeks and then monthly during the study for up to 8 cycles and will be given on day 1 of clofarabine. A peripheral or central intravenous (IV) line will be established. The initial dose rate at the time of the first infusion should be 50/mg/hr for the first hour. If no toxicity is seen, the dose rate may be gradually escalated (50 mg/hr increments at 30 minute intervals) to a maximum of 300 mg/hr. If the first dose of rituximab is well tolerated, the starting flow rate for the administration of subsequent doses will be 100 mg/hr then gradually increased (100 mg/hr increments at 30 minute intervals) not to exceed 400 mg/hr. intervention 2: Phase 1 dosing: Initially, 3 patients will be enrolled into a dose level during the dose escalation portion. Level 1: 2mg fixed dose times 14 days for up to 8 cycles. Level 2: 4mg fixed dose times 14 days for up to 8 cycles. Level 3: 6mg fixed dose times 14 days for up to 8 cycles. Phase II dosing: The phase II dose of oral clofarabine will be determined from the phase 1. intervention 3: We will use an HPLC assay developed by Yu et al31 to determine the DNA methylation (DMI) index in peripheral blood and bone marrow of patients entering this trial and after treatment with clofarabine and rituxan intervention 4: Total RNA will be processed for determination of gene expression by microarray intervention 5: we will scan the microarray slides with an Axon scanner, and quantify data using the GeneSight software. Local background is subtracted and data points with no signal, high background, or spot asymmetry are eliminated. We will adjust genes with low expression and low signal intensity to a minimal raw value of 5: This avoids unwarranted mathematical distortions due to division by decimals \<\< 1. After calculating the ratio of the Cy5 /Cy3 fluorescence signal intensity for each gene, we normalize the data relative to the mean intensity from all genes. intervention 6: None intervention 7: Fifteen µg of DNA will be sonicated for 60 seconds on ice into 200 bp-1000 bp fragments. Samples are then denatured at 1000C for 5 minutes and cooled on ice to prevent re-annealing. Sixty units of nuclease S1 (Invitrogen) and 112.5 mu of snake venom phosphodiesterase I (Sigma) in 12 µl of S1 dilution buffer is then added to the samples and incubated at 370C for 18 hours. Samples are reheated to 1000C for 5 minutes, snap cooled again on ice, and another sixty units of nuclease S1 and 112.5 mu of snake venom phosphodiesterase I are added and incubated at 370C for another 4 to 6 hours. The pH of each sample was raised to 8.5 with 0.5 M Tris, pH 10. Two and a half units of alkaline phosphatase (Sigma) are added and incubated for 2 additional hours at 370C. One hundred µl of 0.05M potassium phosphate, pH 7 is added to final samples before 50 µl of the clear supernatant is injected into the reverse-phase high performance liquid chromatography (HPLC). intervention 8: 50 µl of the clear supernatant is injected into the reverse-phase high performance liquid chromatography (HPLC).

intervention 1: rituximab intervention 2: clofarabine intervention 3: DNA methylation analysis intervention 4: gene expression analysis intervention 5: microarray analysis intervention 6: polymerase chain reaction intervention 7: high performance liquid chromatography intervention 8: laboratory biomarker analysis

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00691652

[ 4 ]

418

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine the long term safety and tolerability of azilsartan medoxomil, once daily (QD), in participants with Essential Hypertension.

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. A major component of blood pressure regulation is the renin-angiotensin-aldosterone system, a system of hormone-mediated feedback interactions that results in the relaxation or constriction of blood vessels in response to various stimuli. Angiotensin II, a polypeptide hormone, is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme as part of the renin-angiotensin-aldosterone system. AII is the principal pressor agent of the renin-angiotensin-aldosterone system with a myriad of effects on the cardiovascular system and on electrolyte homeostasis. Two receptors for angiotensin II have been identified. Angiotensin II type 1 (AT1) receptors are located predominantly in vascular smooth muscle, where activation by angiotensin II results in vasoconstriction, hypertrophic proliferation, and inflammation. In contrast, stimulation of angiotensin II type 2 (AT2) receptors by angiotensin II results in vasodilation, antiproliferative effects, and other effects that are opposite from those of AT1 receptor stimulation. Drugs that modulate the renin-angiotensin-aldosterone system are used commonly worldwide for the treatment of hypertension. Of these, some block the synthesis of angiotensin II by inhibiting angiotensin-converting enzyme inhibitors, while others inhibit the action of angiotensin II by binding directly to the AT1 receptor (angiotensin II receptor blockers), thereby allowing blood vessels to dilate, resulting in a reduction in blood pressure. The effects of angiotensin II receptor blockers on other conditions in which the renin-angiotensin-aldosterone system plays a significant role, such as congestive heart failure, post-myocardial infarction management, and diabetic nephropathy, also are being investigated. Takeda Global Research \& Development Center, Inc. is developing TAK-491 (azilsartan medoxomil) to treat mild to moderate essential hypertension. Nonclinical studies have indicated that azilsartan medoxomil is an antagonist of the AT1 receptor subtype. This study consists of 2 phases. The first phase will be a 26-week, open-label, multicenter phase to evaluate the safety and tolerability of TAK-491 in participants with essential hypertension. Investigators were instructed to manage participants according to a protocol-specified treatment algorithm to achieve target blood pressure. All participants who completed the open-label phase then were randomized into a 6-week double-blind, placebo-controlled (azilsartan medoxomil \[maintained at the final dose from the open-label phase\] or placebo, in addition to their current other antihypertensive medications including chlorthalidone, as applicable) reversal phase to evaluate maintenance/durability of azilsartan medoxomil -mediated blood pressure reduction, as well as potential rebound following the cessation of azilsartan medoxomil. Study participation is anticipated to be about 8.5 Months. 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 and electrocardiograms.

Hypertension

Essential Hypertension Cardiovascular Disease High Blood Pressure Drug Therapy

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as \<140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and \<130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks. Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit. intervention 2: Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks/Week 32. intervention 3: Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other non-ARB antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks/Week 32.

intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin II receptor blocker antihypertensive medications. intervention 3: Placebo

45

0

NCT00696384

[ 5 ]

70

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose.

null

Chronic Plaque Psoriasis

Efalizumab Chronic Plaque Psoriasis Transition from systemic therapies on to Efalizumab

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.

intervention 1: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)

1

City Waterloo | Ontario | Canada | N/A | N/A

0

NCT00697593

[ 3 ]

100

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.

null

Nasopharyngeal Carcinoma

Radiotherapy chemotherapy Drug Targeting loco-regionally advanced nasopharyngeal carcinoma Safety. efficacy

null

1

arm 1: 400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy

[ 0 ]

1

[ 0 ]

intervention 1: one week before and then weekly during radiotherapy

intervention 1: C225 (cetuximab)

1

Guangzhou | Guangdong | China | 113.25 | 23.11667

0

NCT00700440

[ 4 ]

12

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

This is a randomized double-blind study to determine if the administration of a small-dose of ketamine (an anesthetic)added to morphine (an opioid) contributes to reducing pain intensity during open wound care procedure (WCP)in patients who have had a traumatic injury and are in an Intensive Care Unit. Patients will be randomized to receive morphine plus saline (a placebo) or morphine plus ketamine before the WCP. The second time the patient is scheduled for WCP (no less than 24 hours), patients will be crossed over to receive the treatment they did not receive the first time. It is hypothesized that patients who receive the combination of morphine and ketamine will have better pain control during the procedure than patients who just receive morphine.

An open wound care procedure causes pain and sometimes the use of medication such as morphine alone does not adequately help to alleviate pain during this procedure. This study is being done to learn if the administration of another medication named ketamine by the vein in addition to morphine is more effective in alleviating pain during the wound cleansing procedure than the administration of morphine alone. Patients will be eligible for the study if they are 21 years and older, have an open surgical or traumatic wound with a duration of no more than 10 days, had a wound pain intensity score more than 3 in a scale of 0 to 10 where 0 is no pain and 10 is the worst pain imaginable during a previous wound care procedure, and have an intravenous access. A total of 50 patients with these same characteristics are expected to take part in this study. Patients who agree to take part in this study will, one day, receive receive an injection via the vein of morphine 0.05 mg per kilogram of their weight (maximum dose of 4 mg) and another of ketamine 0.25 mg per kilogram of their weight prior receiving the wound care procedure and, on the other day, will receive an injection via the vein of morphine 0.1 mg per kilogram of their weight (maximum dose of 8 mg) and another of saline prior receiving the wound care procedure. They will not be able to know if they receive ketamine or saline the first time or second time. Ketamine is a drug approved by the U.S. Food and Drug Administration (FDA) for anesthesia but not approved to provide analgesia (relieve pain). However, small doses of ketamine are used (out of its indications) in the clinical area to provide analgesia, and its analgesic properties have been studied by many researchers. Before the wound care procedure subjects will be asked to rate their wound pain intensity at rest at that moment and in the past 24 hours (including "worst" and "average" pain), overall pain intensity at rest at this moment and "worst" and "average" in the past 24 hours using a 0 to 10 scale where 0 is no pain and 10 is the worst pain imaginable. They will be given a list of common words that might describe their pain, and a body outline to indicate where the pain is. In addition, they will be asked to rate their level of sleepiness using a 0 to 10 scale where 0 is not at all sleepy and 10 is extremely sleepy. After removing the outer dressing, patients will be tested for pain sensitivity around the wound with a thin, short length of plastic (like a little straw), which will be pressed against their skin from the outside of the wound towards the wound and they will be asked to report a distinct change in perception. The first point where a "painful", "sore", or "sharper" feeling occurs will be marked in the skin to measure the distance of this mark to the wound. If no change in perception occurs, stimulation will be stopped 0.5 cm from the wound. This measure is experimental. Immediately after the wound care procedure the following will be measured: (1) "worst" wound pain intensity experienced during the wound care procedure, (2) description of pain quality during the wound care procedure, (3) level of sleepiness, (4) side effects such as unpleasant sensation will be measured using a 0 to 10 scale, where 0 means no unpleasant sensation at all and 10 means extremely unpleasant sensation, and finally (5) pain sensitivity around the wound using a thin, short length of plastic. The length of time needed to take part in this study will depend on how long the wound care procedure takes. The time could be approximately 45 minutes to 60 minutes (1 hour) per visit and 90 minutes (1½ hour) to 120 minutes (2 hours) in total for the study because 2 days are needed to complete the study.

Wound Care Pain Intensity Hyperalgesia Nausea Vomiting Hallucinations

wound care procedural pain intensity procedural hyperalgesia wound care pain intensity wound care hyperalgesia Wound care pain quality Level of drowsiness level of nausea Level of vomiting Level of hallucinations Level of dysphoria

null

2

arm 1: During the first wound care procedure, patients received morphine 0.05 mg/kg (a maximum dose of 4 mg) plus ketamine 0.25 mg/kg (MK). Then, during the second wound care procedure, patients received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline (MS). arm 2: During the first wound care procedure, patients received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline (MS). Then, during the second wound care procedure, patients received morphine 0.05 mg/kg (a maximum dose of 4mg) plus ketamine 0.25 mg/kg (MK)

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Morphine 0.05 mg/kg (maximum dose of 4 mg) IV plus Ketamine 0.25 mg/kg IV. Then, Morphine 0.1 mg/kg (maximum dose of 8 mg) IV plus Saline IV intervention 2: Morphine 0.1 mg/kg (maximum dose of 8 mg) IV plus Saline IV. Then, Morphine 0.05 mg/kg (maximum dose of 4 mg) IV plus Ketamine 0.25 mg/kg IV.

intervention 1: Morphine plus Ketamine intervention 2: Morphine plus Saline (placebo)

2

San Francisco | California | United States | -122.41942 | 37.77493 San Juan | N/A | Puerto Rico | -66.10572 | 18.46633

0

NCT00701909

[ 4 ]

688

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.

null

Hypertension

Essential Hypertension Stage II

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. intervention 2: During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.

intervention 1: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) intervention 2: Aliskiren (300 mg)

8

East Hanover | New Jersey | United States | -74.36487 | 40.8201 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Quito | N/A | Ecuador | -78.52495 | -0.22985 Berlin | N/A | Germany | 13.41053 | 52.52437 Guatemala City | N/A | Guatemala | -90.51327 | 14.64072 Rome | N/A | Italy | 12.51133 | 41.89193 Basel | N/A | Switzerland | 7.57327 | 47.55839 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987

0

NCT00705575

[ 4 ]

756

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.

null

Hypertension

Hypertension ≥ 65 years aliskiren placebo light meal

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Placebo tablet taken once daily in the morning with a light meal. intervention 2: Aliskiren 75 mg tablet taken once daily in the morning with a light meal. intervention 3: Aliskiren 150 mg tablet taken once daily in the morning with a light meal. intervention 4: Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

intervention 1: Placebo intervention 2: Aliskiren 75 mg intervention 3: Aliskiren 150 mg intervention 4: Aliskiren 300 mg

8

Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Prague | N/A | Czechia | 14.42076 | 50.08804 Berlin | N/A | Germany | 13.41053 | 52.52437 Reykjavik | N/A | Iceland | -21.89541 | 64.13548 Rome | N/A | Italy | 12.51133 | 41.89193 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Warsaw | N/A | Poland | 21.01178 | 52.22977 Bratislava | N/A | Slovakia | 17.10674 | 48.14816

0

NCT00706134

[ 4 ]

402

RANDOMIZED

CROSSOVER

2DIAGNOSTIC

4QUADRUPLE

false

0ALL

false

This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.

Issues on safety will be addressed in Adverse Events section.

Diagnostic Imaging Central Nervous System Diseases

Patients referred for a contrast-enhanced MRI of the CNS CNS Imaging

null

2

arm 1: Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2. arm 2: Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) intervention 2: Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.

intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadoteridol (ProHance)

79

0

NCT00709852

[ 3 ]

373

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.

null

Rheumatoid Arthritis

Rheumatoid Arthritis RA AZD5672

null

6

arm 1: None arm 2: 20mg arm 3: 50mg arm 4: 100mg arm 5: 150mg arm 6: None

[ 1, 0, 0, 0, 0, 2 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: 20 mg oral, once daily intervention 2: 50 mg, subcutaneous injection, weekly intervention 3: placebo, oral, once daily intervention 4: 50 mg oral, once daily intervention 5: 100 mg oral, once daily intervention 6: 150 mg oral, once daily

intervention 1: AZD5672 intervention 2: Etanercept intervention 3: Placebo intervention 4: AZD5672 intervention 5: AZD5672 intervention 6: AZD5672

49

Blagoevgrad | N/A | Bulgaria | 23.1 | 42.01667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Medellín | Colombia | Colombia | -75.57151 | 6.245 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Bucaramanga | N/A | Colombia | -73.11895 | 7.125 Česká Lípa | N/A | Czechia | 14.53764 | 50.68551 České Budějovice | N/A | Czechia | 14.47434 | 48.97447 Hlučín | N/A | Czechia | 18.19196 | 49.89795 Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Praha 11 - Chodov | N/A | Czechia | N/A | N/A Zlín | N/A | Czechia | 17.67065 | 49.22645 Békéscsaba | N/A | Hungary | 21.1 | 46.68333 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Kecskemét | N/A | Hungary | 19.69128 | 46.90618 Makó | N/A | Hungary | 20.48333 | 46.21667 Sopron | N/A | Hungary | 16.59049 | 47.68501 Siena | SI | Italy | 11.33064 | 43.31822 Valmiera | N/A | Latvia | 25.42751 | 57.54108 Birkirkara | N/A | Malta | 14.46111 | 35.89722 Bialystok | N/A | Poland | 23.16433 | 53.13333 Działdowo | N/A | Poland | 20.17004 | 53.23958 Krakow | N/A | Poland | 19.93658 | 50.06143 Lublin | N/A | Poland | 22.56667 | 51.25 Sopot | N/A | Poland | 18.56003 | 54.4418 Szczecin | N/A | Poland | 14.55302 | 53.42894 Torun | N/A | Poland | 18.59814 | 53.01375 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Brasov | N/A | Romania | 25.60613 | 45.64861 Bucharest | N/A | Romania | 26.10626 | 44.43225 Ploieşti | N/A | Romania | 26.01667 | 44.95 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Yaroslavl | N/A | Russia | 39.87368 | 57.62987 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Niška Banja | N/A | Serbia | 22.0057 | 43.29507 Banská Bystrica | N/A | Slovakia | 19.15349 | 48.73946 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Piešťany | N/A | Slovakia | 17.82591 | 48.59479 Pretoria | Gauteng | South Africa | 28.18783 | -25.74486 Durban | KwaZulu-Natal | South Africa | 31.0292 | -29.8579 Cape Town | Western Cape | South Africa | 18.42322 | -33.92584 Donetsk | N/A | Ukraine | 37.80224 | 48.023 Ivano-Frankivsk | N/A | Ukraine | 24.71248 | 48.92312 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kyiv | N/A | Ukraine | 30.5238 | 50.45466 Simferopol | N/A | Ukraine | 34.11079 | 44.95719

0

NCT00713544

[ 4 ]

279

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).

The primary objective of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD). The primary efficacy criterion will be the change in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale (CAARS), from start of treatment to the end of the double-blind treatment. Hypothesis of the primary objective states that either PR OROS methylphenidate dose is more effective than placebo after 13 weeks of treatment in adult patients with ADHD. This is a multicentre, double-blind, randomized, placebo-controlled, parallel group, dose-response study. Patients will be randomized into one of 3 treatment groups to receive oral dosages of PR OROS methylphenidate 54 or 72 mg, or placebo once daily. The study includes a treatment period of 13 weeks. Patients will be titrated from a starting dose of 36 mg/day for 7 days, to 54 or 72 mg/day at Day 8, after which treatment will be administered for 12 weeks. The study will include a screening period of up to 2 weeks, during which current therapy, not allowed during the study can be tapered down and discontinued (with the exception of fluoxetine or MAO (monoamine oxidase) inhibitors for which a maximum screening period of 4 weeks will be allowed). A post-study visit for collection of additional efficacy and safety data will be scheduled for one week after a patient's final dose of study drug. Adults with a diagnosis of ADHD according to DSM-IV criteria with some symptoms before age 7 years that continue to meet these criteria at the time of assessment will be enrolled in this study. ADHD is not diagnosed if the symptoms are better accounted for by another psychiatric disorder (e.g. mood disorder, anxiety disorder, psychotic disorder, personality disorder). The patient (and if possible, informant) must also describe a chronic course of ADHD symptomatology from childhood to adulthood. The description of this chronic course can be patient-based and previous documented diagnosis and/or treatment is not required. Approximately 300 patients (100 in each randomized treatment group) will participate in this study. The primary efficacy criterion will be the change in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated CAARS from baseline to the end of treatment (end of 13 weeks or last post-baseline assessment). This variable will be compared between each dosage group and placebo using an ANCOVA model. Other end points will include changes from baseline to the end of the treatment in the CAARS subscales and assessment of the clinical global impression - global change subscale (CGI-C). Onset of therapeutic effect and responder rate will also be determined. In addition, morning / evening (8 pm) CAARS-S:S assessments will be performed at baseline and on Days 34, 35, 90 and 91. Safety evaluations will include monitoring of adverse events (AEs), clinical laboratory tests (hematology; biochemistry), pregnancy testing, vital signs (supine and standing blood pressure, pulse) and weight, ECG. Patients will be randomized to receive PR OROS methylphenidate 54 or 72 mg, or placebo once daily. Study drug will be administered daily in the morning for up to 13 weeks. Since there is no food effect with methylphenidate, drug administration can be under fed or fasted conditions. Patients will start at a dosage of 36 mg. At Week 2, patients will receive 54 or 72 mg PR OROS methylphenidate for 12 weeks.

Attention Deficit/ Hyperactivity Disorder

Adult ADHD Concerta

null

3

arm 1: prolonged release (PR) OROS methylphenidate 54 mg 18+36mg once daily for 13 weeks arm 2: prolonged release (PR) OROS methylphenidate 72 mg 2x36mg once daily for 13 weeks arm 3: Placebo 2xplacebo once daily for 13 weeks

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 18+36mg once daily for 13 weeks intervention 2: 2x36mg once daily for 13 weeks intervention 3: 2xplacebo once daily for 13 weeks

intervention 1: prolonged release (PR) OROS methylphenidate 54 mg intervention 2: prolonged release (PR) OROS methylphenidate 72 mg intervention 3: Placebo

42

Antwerp | N/A | Belgium | 4.40026 | 51.22047 Brussels | N/A | Belgium | 4.34878 | 50.85045 Kortenberg | N/A | Belgium | 4.54353 | 50.88982 Mechelen | N/A | Belgium | 4.47762 | 51.02574 Mons | N/A | Belgium | 3.95229 | 50.45413 Aarhus | N/A | Denmark | 10.21076 | 56.15674 Hjørring | N/A | Denmark | 9.98229 | 57.46417 Holstebro | N/A | Denmark | 8.61607 | 56.36009 Helsinki | N/A | Finland | 24.93545 | 60.16952 Oulu | N/A | Finland | 25.46816 | 65.01236 Pori | N/A | Finland | 21.78333 | 61.48333 Montpellier | N/A | France | 3.87635 | 43.61093 Nice | N/A | France | 7.26608 | 43.70313 Paris | N/A | France | 2.3488 | 48.85341 Ahrensburg | N/A | Germany | 10.22593 | 53.67515 Aschaffenburg | N/A | Germany | 9.15214 | 49.97704 Berlin | N/A | Germany | 13.41053 | 52.52437 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Essen | N/A | Germany | 7.01228 | 51.45657 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Mannheim | N/A | Germany | 8.46694 | 49.4891 München | N/A | Germany | 13.31243 | 51.60698 Saarbrücken | N/A | Germany | 7.00982 | 49.23262 Würzburg | N/A | Germany | 9.95121 | 49.79391 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 The Hague | N/A | Netherlands | 4.29861 | 52.07667 Bryne | N/A | Norway | 5.64766 | 58.73536 Oslo | N/A | Norway | 10.74609 | 59.91273 Ottestad | N/A | Norway | 11.1366 | 60.74743 Skien | N/A | Norway | 9.60897 | 59.20962 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Huddinge | N/A | Sweden | 17.98192 | 59.23705 Linköping | N/A | Sweden | 15.62157 | 58.41086 Lund | N/A | Sweden | 13.19321 | 55.70584 Malmo | N/A | Sweden | 13.00073 | 55.60587 Örebro | N/A | Sweden | 15.2066 | 59.27412 Uppsala | N/A | Sweden | 17.63889 | 59.85882 Basel Bs | N/A | Switzerland | N/A | N/A Zurich | N/A | Switzerland | 8.55 | 47.36667 Cambridge | N/A | United Kingdom | 0.11667 | 52.2 Swansea | N/A | United Kingdom | -3.94323 | 51.62079

0

NCT00714688

[ 3 ]

32

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and duration of action), of a single dose of formoterol fumarate in combination with mometasone furoate to placebo in children of 5-11 years with persistent asthma. The study will also assess the bronchodilatory effect of a single dose of formoterol fumarate alone and in combination with mometasone furoate delivered via a pressurized metered dose inhaler (pMDI) to the bronchodilatory effect of formoterol fumarate delivered via a dry powder inhaler (DPI). Furthermore, pharmacokinetic assessments of plasma and urine will also be conducted throughout the study to assess systemic exposure following administration of the study medication.

null

Asthma

Asthma Children Persistent asthma

null

4

arm 1: Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication. arm 2: Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication. arm 3: Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication. arm 4: Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.

[ 0, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg. intervention 2: Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg). intervention 3: Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI). intervention 4: Placebo to formoterol fumarate DPI delivered via DPI intervention 5: Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI

intervention 1: Mometasone furoate/formoterol fumarate (MFF) intervention 2: Formoterol fumarate 12 μg pMDI (F12M) intervention 3: Formoterol fumarate 12 μg DPI (F12D) intervention 4: Placebo to F12D intervention 5: Placebo to F12M/MFF

9

0

NCT00746330

[ 3 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.

Meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. The lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid margin; 4) prevent the contamination of the tear film by sebaceous lipids; 5) prevent damage to the skin of the lid margin. In dry eye syndrome, blepharitis, meibomian gland dysfunction, and meibomitis the glands are the central pathophysiology of disease and thus a potential target for therapy.

Meibomian Gland Dysfunction

Meibomian Gland Dysfunction Dry Eye Syndrome

null

2

arm 1: testosterone ophthalmic solution 0.03% arm 2: vehicle of testosterone ophthalmic solution

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: testosterone ophthalmic solution for 128 days intervention 2: vehicle of testosterone ophthalmic solution for 128 days

intervention 1: testosterone ophthalmic solution intervention 2: vehicle of testosterone ophthalmic solution

1

Andover | Massachusetts | United States | -71.137 | 42.65843

0

NCT00755183

[ 4 ]

885

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to ramipril for treating Essential Hypertension.

A major component of blood pressure regulation is the renin-angiotensin-aldosterone system, a system of hormone-mediated feedback interactions that results in the relaxation or constriction of blood vessels in response to various stimuli. Angiotensin II, a polypeptide hormone, is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme as part of the renin-angiotensin-aldosterone system. Angiotensin II is the principal pressor agent of the renin-angiotensin-aldosterone system with a myriad of effects on the cardiovascular system and on electrolyte homeostasis. Two receptors for angiotensin II have been identified. Angiotensin II type 1 receptors are located predominantly in vascular smooth muscle, where activation by angiotensin II results in vasoconstriction, hypertrophic proliferation, and inflammation. In contrast, stimulation of angiotensin II type 2 receptors by angiotensin II results in vasodilatation, antiproliferative effects that are opposite from those of angiotensin II type 1 receptor stimulation. Drugs that modulate the renin-angiotensin-aldosterone system are used commonly worldwide for the treatment of hypertension. Of these, some block the synthesis of angiotensin II by inhibiting angiotensin-converting enzymes, while others inhibit the action of angiotensin II by binding directly to the angiotensin II type 1 receptor (called angiotensin II receptor blockers), thereby causing vasodilatation of blood vessels, resulting in a reduction in blood pressure. The effects of angiotensin II receptor blockers on other conditions in which the renin-angiotensin-aldosterone system plays a significant role, such as congestive heart failure, postmyocardial infarction management and diabetic nephropathy have also been investigated. Although antihypertensive agents are effective at the appropriate dose, the majority have side effects that limit their use. Angiotensin-converting enzyme inhibitors are commonly associated with cough and more rarely with angioedema. Beta-blockers are associated with fatigue and erectile dysfunction, calcium antagonists with peripheral edema and diuretics with metabolic complications. As a class, angiotensin II receptor blockers generally are considered more tolerable than other classes of hypertensive agents, although there is still a need for compounds with improved tolerability and efficacy for the treatment of hypertension. TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker with high affinity for, and selective antagonistic activity at, the angiotensin II type 1 receptor, and is being developed for clinical use as an antihypertensive agent. Ramipril is an angiotensin-converting enzyme inhibitor widely prescribed in Europe and Asia for the treatment of mild to moderate essential hypertension. This study is designed to compare the efficacy and safety/tolerability of azilsartan medoxomil and ramipril for the treatment of hypertension. Participants in this study will be seen twice during the first month, then once a month for five months. Participants will also be required to fast for 8 hours prior to each visit to the study center. Total duration of study participation is 24-weeks, plus a safety follow up phone call after the study has ended.

Hypertension

Essential Hypertension Hypertension Drug Therapy Blood Pressure, High Vascular Disease Cardiovascular Disease

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks. intervention 2: Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks. intervention 3: Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.

intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil intervention 3: Ramipril

72

Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Paide | N/A | Estonia | 25.55722 | 58.88556 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Tartu | N/A | Estonia | 26.72509 | 58.38062 Viljandi | N/A | Estonia | 25.59 | 58.36389 Joensuu | N/A | Finland | 29.76316 | 62.60118 Mikkeli | N/A | Finland | 27.27227 | 61.68857 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Augsburg | N/A | Germany | 10.89851 | 48.37154 Bad Krozingen | N/A | Germany | 7.7 | 47.91667 Bad Segeberg | N/A | Germany | 10.30745 | 53.93775 Berlin | N/A | Germany | 13.41053 | 52.52437 Cologne | N/A | Germany | 6.95 | 50.93333 Dortmund | N/A | Germany | 7.466 | 51.51494 Dresden | N/A | Germany | 13.73832 | 51.05089 Essen | N/A | Germany | 7.01228 | 51.45657 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Goch | N/A | Germany | 6.15895 | 51.67873 Großheirath | N/A | Germany | 10.9505 | 50.17603 Hamburg | N/A | Germany | 9.99302 | 53.55073 Karlsruhe | N/A | Germany | 8.40444 | 49.00937 Künzing | N/A | Germany | 13.08333 | 48.66667 Leipzig | N/A | Germany | 12.37129 | 51.33962 Lübeck | N/A | Germany | 10.68729 | 53.86893 Mannheim | N/A | Germany | 8.46694 | 49.4891 München | N/A | Germany | 13.31243 | 51.60698 Nuremberg | N/A | Germany | 11.07752 | 49.45421 Siegen | N/A | Germany | 8.02431 | 50.87481 Deurne | N/A | Netherlands | 5.79722 | 51.46 Ewijk | N/A | Netherlands | 5.7375 | 51.87 Geleen | N/A | Netherlands | 5.82917 | 50.97417 Lichtenvoorde | N/A | Netherlands | 6.56667 | 51.98667 Oude Pekela | N/A | Netherlands | 7.00972 | 53.10417 Rijswijk | N/A | Netherlands | 4.32501 | 52.03634 Roelofarendsveen | N/A | Netherlands | 4.63333 | 52.20333 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Wildervank | N/A | Netherlands | 6.8625 | 53.08083 Gdansk | N/A | Poland | 18.64912 | 54.35227 Gniewkowo | N/A | Poland | 18.40785 | 52.89461 Kamieniec Ząbkowicki | N/A | Poland | 16.87921 | 50.52541 Katowice | N/A | Poland | 19.02754 | 50.25841 Libiąż | N/A | Poland | 19.31568 | 50.10396 Lodz | N/A | Poland | 19.47395 | 51.77058 Oława | N/A | Poland | 17.2926 | 50.9466 Poznan | N/A | Poland | 16.92993 | 52.40692 Płock | N/A | Poland | 19.70638 | 52.54682 Skierniewice | N/A | Poland | 20.15837 | 51.95485 Tarnów | N/A | Poland | 20.98698 | 50.01381 Moscow | N/A | Russia | 37.61556 | 55.75222 Perm | N/A | Russia | 56.25017 | 58.01046 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Niš | N/A | Serbia | 21.90333 | 43.32472 Niška Banja | N/A | Serbia | 22.0057 | 43.29507 Zemun | N/A | Serbia | 20.40116 | 44.8458 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Galanta | N/A | Slovakia | 17.72747 | 48.19001 Levice | N/A | Slovakia | 18.60705 | 48.21563 Lučenec | N/A | Slovakia | 19.66708 | 48.33249 Rimavská Sobota | N/A | Slovakia | 20.02239 | 48.38284 Boden | N/A | Sweden | 21.68864 | 65.82518 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Luleå | N/A | Sweden | 22.15465 | 65.58415 Lund | N/A | Sweden | 13.19321 | 55.70584 Malmo | N/A | Sweden | 13.00073 | 55.60587 Örebro | N/A | Sweden | 15.2066 | 59.27412 Skene | N/A | Sweden | 12.64196 | 57.48995

0

NCT00760214

[ 5 ]

451

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.

null

Hypertension

Hypertension older population aliskiren hydrochlorothiazide systolic blood pressure diastolic blood pressure amlodipine, stage 2

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks intervention 2: Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks

intervention 1: Aliskiren intervention 2: Hydrochlorothiazide

1

East Hanover | New Jersey | United States | -74.36487 | 40.8201

0

NCT00760266

[ 4 ]

287

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).

The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.

Chronic Low Back Pain

Effect on sleep interference by pain

null

3

arm 1: 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). arm 2: 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). arm 3: 2 placebo tablets, twice daily, for 4 weeks (double-blind period).

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: ABT-712 extended-release tablet intervention 2: Placebo tablet

intervention 1: ABT-712 intervention 2: Placebo

31

0

NCT00763321