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

[ 3 ]

41

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine whether baclofen is effective in reducing smoking urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers.

OBJECTIVES: The long-term objective of this research program is to improve treatments for tobacco smokers by investigating the effects of medications on self-reported and psychophysiological responses to smoking cues and on behavioral-economic measures of smoking reinforcement during a period of tobacco deprivation. The specific objectives of the present application are to investigate the dose-response effects of baclofen (a gamma-aminobutyric acid B agonist), 1) on urge, and withdrawal, and 2) on the reinforcement value of smoking as measured by choices for puffs on cigarettes versus an alternative reinforcer among current smokers after 4 hours of smoking deprivation. RESEARCH PLAN: The study will use a randomized placebo-controlled between-subjects design with 64 smokers to investigate the effects of placebo and two doses (20 or 40 mg/day) of baclofen on urge to smoke and withdrawal and on choices for smoking versus money after 4 hours of deprivation. METHODS: Participants will be healthy people who smoke at least 10 cigarettes per day and who are motivated for future smoking cessation. On Day 0, a baseline session will occur after 4 hours of smoking deprivation and on Day 10 of medication the same assessments will be repeated after the final medication dose has been stabilized for at least 3 days and after 4 hours of supervised smoking deprivation has occurred. Medication differences in urge and withdrawal and in the reinforcement value of smoking cigarettes will be investigated. Dependent measures of urge and withdrawal will be by self-report. The dependent measure of reinforcement value is the ratio of choices for cigarette puffs versus money during a subsequent 2-1/2 hr period. The choice procedure will clarify the relative reinforcement value of smoking while controlling for non-specific decreases in general activity level resulting from sedation. Nicotine self-administration during the medication period will be quantified using saliva cotinine, as a secondary effect. CLINICAL RELEVANCE: More effective interventions for tobacco use could result in less suffering and mortality and in considerable savings in health care costs associated with cardiovascular disease, pulmonary disorders, and cancer.

Nicotine Use Disorder Nicotine Dependence Smoking Tobacco Use Disorder

Baclofen Conditioning, Classical Nicotine Smoking

null

2

arm 1: Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12. arm 2: Placebo capsules identical to active medication, 3/day for 12 days.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Dosing taken orally for a total of 12 days: 40mg/day vs. 0mg/day (placebo tabs). The 40mg condition will receive 15mg/day the first 3 days(Days 1,2,3), 30mg/day for 3 days(Days 4,5,6), and 40mg/day for 3 days(Days 7,8,9). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day 11), and 10mg/day(Day 12). intervention 2: Matched placebo capsules containing inert filler taken orally for a total of 12 days

intervention 1: Baclofen intervention 2: Placebo

1

Providence | Rhode Island | United States | -71.41283 | 41.82399

0

NCT00257894

[ 3 ]

99

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.

null

Myelodysplastic Syndrome

Myelodysplastic Syndrome Decitabine Dacogen MGI Pharma

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 20mg/m\^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.

intervention 1: Decitabine

21

0

NCT00260065

[ 0 ]

51

RANDOMIZED

FACTORIAL

0TREATMENT

1SINGLE

false

0ALL

true

The primary goal of this study is to provide a better understanding of: 1) the pathogenesis and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2) the effect of marked weight loss on the histologic and metabolic abnormalities associated with NAFLD. The following hypotheses will be tested: 1. obesity causes hepatic fat accumulation because of excessive fatty acid release from fat tissue and increased free fatty acid availability, 2. increased hepatic (liver) fat content causes insulin-resistant glucose (sugar) production by the liver and altered liver protein synthesis, 3. increased hepatic fat content causes increased lipid (fat) peroxidation, hepatic inflammation, necrosis and fibrosis, and 4. marked weight loss improves NAFLD once patients are weight stable.

Obesity is a major risk factor for non-alcoholic fatty liver disease (NAFLD), which represents a spectrum of liver diseases. NAFLD is a major health problem in the US because of its high prevalence and causal relationship with serious liver abnormalities. However, the mechanism(s)responsible for developing NAFLD in obese persons and the effects on liver function are not known. This gap in knowledge has made it difficult to identify effective therapy. The results from these studies will lay the groundwork for the development of novel therapeutic interventions for NAFLD in obese patients.

Non-alcoholic Fatty Liver Disease

non-alcoholic fatty liver disease obesity fatty liver disease

null

4

arm 1: Subjects, having previously diagnosed with NAFLD, were given Niacin for 16 weeks. The dosage was 500mg/day for week 1, 1000mg/day for week 2, 1500mg/day for week three and 2000mg/day for weeks 4 through 16. arm 2: Subjects were found to have intrahepatic triglyceride levels below the threshold for Non-Alcoholic Fatty Liver Disease (NAFLD). For this study that threshold was set at 10% intrahepatic triglyceride content as determined by magnetic resonance spectroscopy. These control subjects did not participate in any intervention. Only baseline features were characterized for this arm. arm 3: Subjects diagnosed with NAFLD were randomized to fenofibrate, an oral medication, nightly for eight weeks. Subjects will be given a dose of 200mg/day. arm 4: These subjects were diagnosed with Non-Alcoholic Fatty Liver Disease (NAFLD) and received an 8 week course of a placebo pill. Their baseline characteristics were averaged into the overall NAFLD baseline characteristics along with the baseline data for the two intervention groups.

[ 0, 4, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Subjects randomized to Niacin therapy will be treated with Niacin at night for 16 wks to reduce plasma free fatty acid concentrations. The dose of medication will be gradually increased: 500 mg/day during week 1, 1000 mg/day during week 2, 1500 mg/day during week 3, and 2000mg/day during weeks 4-16. intervention 2: Subjects randomized to fenofibrate will be treated with 200 mgs per day for eight weeks. intervention 3: Subjects randomized to placebo will be treated with one placebo pill per day for eight weeks.

intervention 1: Niacin intervention 2: fenofibrate intervention 3: placebo

1

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

0

NCT00262964

[ 4 ]

237

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD).

Clostridium difficile is a bacterium that proliferates when normal colonic flora have been altered, most commonly due to antibiotic use. Clostridium difficile is non-invasive and localized to the lumen of the colon. Once established, it produces 2 potent toxins, A and B. The principal reservoir for Clostridium difficile is the hospital environment, with the risk of acquiring Clostridium difficile increasing in direct proportion to the length of hospital stay. Patients with CDAD typically present with profuse watery or mucoid diarrhea and cramping abdominal pain. Additional symptoms include fever, nausea, anorexia, malaise, and bloody stool. More severe cases may be complicated by dehydration, electrolyte disturbances, ileus, and peritonitis. Systemic manifestations may include prerenal azotemia, sepsis syndrome, and toxic colitis. White blood cell counts (WBCs) also may be markedly elevated with a shift to immature forms. Extreme presentation of fulminant colitis may require a colectomy and even result in death. Symptoms of CDAD may begin a few days after initiation of antibiotic therapy or up to 8 weeks after its discontinuation.

Clostridium Infections Diarrhea

Clostridium difficile-associated Diarrhea (CDAD) CDAD C diff

null

2

arm 1: rifaximin 400mg taken 3 times a day arm 2: vancomycin 125mg taken 4 times a day

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Rifaximin (Xifaxan) intervention 2: Vancomycin

63

0

NCT00269399

[ 0 ]

19

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

1FEMALE

false

The overall design of the study is to perform both a PET and MRI scan on objectively identified borderline personality disorder patients, to treat them with olanzapine for 8 weeks, and to then re-scan the patients with PET.

The primary objective of this proposed study will be to compare the baseline PET scan to the endpoint scan in 15 BPD patients who have been treated with olanzapine. The comparison of the scans will be done through a statistical image analysis, using a pixel-by-pixel group mean subtraction strategy with appropriate correction for multiple comparisons. In an exploratory fashion we will compare frontal and temporal regions of interest to address hypotheses of which areas of the brain might show changes with olanzapine treatment. A secondary objective is to use a normal database to compare the baseline PET scan of the 15 patients in a medication free state to normal subjects. The advantage of this strategy is the ability to closely match subjects by gender and age. As noted earlier, Dr. Pardo has data on 35 control subjects studied on the same scanner we plan to use for this study.

Borderline Personality Disorder

Borderline Personality Disorder BPD PET olanzapine brain

null

1

arm 1: Open-label Olanzapine.

[ 0 ]

1

[ 0 ]

intervention 1: Olanzapine 2.5mg by mouth at bedtime x2 weeks, then Olanzapine 5mg by mouth at bedtime x2 weeks, then Olanzapine 7.5mg by mouth at bedtime x4 weeks.

intervention 1: olanzapine

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00275301

[ 3 ]

20

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Nitric oxide is an important marker of airway inflammation in asthma. Nitric oxide may have a protective role in patients with moderate to severe asthma. The investigators believe that a natural amino acid, L-arginine, that augments nitric oxide levels can decrease asthma exacerbations and improve the asthma care of moderate to severe asthma patients. This study is a randomized, placebo controlled trial in which subjects will receive either 3 months of L-arginine supplementation or a placebo. The investigators will monitor subjects' symptoms, the number of asthma exacerbations, and lung function. In addition, we will draw blood, obtain induced sputum samples and measure exhaled breath nitric oxide levels at each monthly visit.

The primary objective of this 3 month clinical study is to determine if supplemental L-arginine can decrease the number of asthma exacerbations in patients with severe asthma. L-arginine, a natural amino acid, produces nitric oxide (NO) when it is converted to L-citrulline in the presence of the nitric oxide synthase enzymes. We and others have found that NO can protect against allergic airway inflammation, airway hyperresponsiveness and airway fibrosis in various animal models. In addition, we have found that arginase I expression correlates strongly with the lymphocyte and eosinophil influx into the lung and this enzyme may regulate the airway inflammatory response. Our central hypothesis is that L-arginine will increase NO levels in the lung and decrease the number of acute exacerbations of asthma. It may do this by either decreasing the number of Th2 lymphocytes or down-regulating arginase I expression or both. Our specific aims are, therefore, 1. To test the hypothesis, in a randomized, double-blinded, placebo controlled trial, that 3 months of L-arginine supplementation will decrease the number of acute asthma exacerbations in severe asthmatic patients, 2. To determine whether L-arginine decreases the ratio of peripheral blood Th2 to Th1 lymphocytes and 3. To determine whether L-arginine will modulate serum arginase I/II levels and their downstream products. Patients will be recruited primarily from the UC Davis Asthma Network (UCAN) clinics, which focus on the care of severe asthmatics, and the study will be performed at the UC Davis/VA General Clinical Research Center.

Asthma

Airway Inflammation Moderate persistent asthma Severe Persistent Asthma

null

2

arm 1: Enrolled subjects will take L-arginine orally, at 0.1 g/kg/day. Subjects will take three to four 1 g capsules (based on weight) of L-arginine twice daily for three months. L-arginine capsules were obtained from Jarrow Pharmaceuticals. arm 2: Enrolled subjects took three to four placebo capsules that matched color and size of the intervention twice daily for three months. Matching placebo capsules were obtained from Jarrow Pharmaceuticals.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: subjects will take matching 0.01 g/kg/day of L-arginine in divided doses for thre months. intervention 2: Placebo tablets that match the L-arginine intervention tablets will be given for three months

intervention 1: L-arginine intervention 2: Placebo

1

Sacramento | California | United States | -121.4944 | 38.58157

0

NCT00280683

[ 4 ]

122

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

null

Psychosis

null

2

arm 1: Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID) arm 2: Dose titration from 5 mg to 10 mg BID

[ 0, 0 ]

1

[ 0 ]

intervention 1: Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).

intervention 1: Asenapine

0

null

0

NCT00281320

[ 5 ]

68

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This research study is being conducted to test the effects of two drugs on blood lipids (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or "pre-diabetes" (both of which have a condition called "insulin-resistance"). These products are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels, increase HDL-cholesterol levels and do so without altering glucose levels.

The insulin resistance syndrome (IRS) afflicts approximately 25% of the US adult population. Its principal components include some or all of the following: central obesity, elevated triglyceride levels, decreased high density lipoprotein cholesterol (HDL-C) levels, a preponderance of small, dense low density lipoprotein (LDL) particles, hyperglycemia, hypertension, and increased thrombotic tendency. Subjects with the IRS are at increased risk for type 2 diabetes and/or coronary heart disease (CHD). While lifestyle changes (diet and exercise) often improve many of the manifestations of the IRS, pharmacotherapy is often needed to normalize individual components. In recent studies from our laboratory, niacin and fish oil (n-3 fatty acids, FA) used in combination in insulin resistant individuals led to an expected improved the lipid phenotype (reduced triglycerides, increased HDL-C, and fewer, small, dense LDL particles). What was not expected, however, was that an important marker of adipose tissue insulin resistance - meal-induced suppression of free fatty acid (FFA) flux - would be improved as well. Further, knowing that these agents (given as monotherapy) have been reported to worsen glycemia in diabetic subjects, we were surprised to find no significant deterioration in glycemic control. Further preliminary studies in patients with poorly-controlled type 2 diabetes confirmed the ability of this combination of over-the-counter natural agents to significantly improve the lipid profile without adverse effects on glycemia. Our working hypothesis is that excessive FFA flux from adipose tissue raises serum triglyceride concentrations and leads to other manifestations of the IRS. FFA flux is chronically elevated in insulin resistant subjects due to the insensitivity (i.e., resistance) of their adipocytes to the anti-lipolytic effects of insulin. Released FFA (especially from visceral adipose depots) stimulate hepatic triglyceride synthesis, leading to elevated serum triglyceride levels which subsequently contribute to reduced HDL-C and increased small, dense LDL concentrations. In addition, a high FFA flux can interfere with whole body glucose disposal. If this hypothesis is true, then interventions that improve adipocyte insulin sensitivity may be expected to improve a spectrum of risk factors associated with the insulin resistant state. Since our preliminary studies support this hypothesis, we propose the following four specific aims which will be tested in a 4-arm, randomized, placebo-controlled, double blind trial: Specific Aim 1. To test the hypothesis that n-3 FA and niacin (given singly and in combination) will enhance insulin-mediated suppression of FFA rate of appearance (Ra; a surrogate for adipose tissue insulin sensitivity) in insulin resistant subjects. Specific Aim 2. To test the hypothesis that n-3 FA and niacin (given singly and in combination) will improve insulin sensitivity in insulin resistant subjects. Specific Aim 3. To test the hypothesis that n-3 FA and niacin (given singly and in combination) will reduce VLDL-triglyceride production rates in insulin resistant subjects. Specific Aim 4. To test the hypothesis that n-3 FA and niacin (given singly and in combination) will improve the dyslipidemic profile (i.e., reduce serum triglyceride and small, dense LDL concentrations and elevate HDL-C concentrations) in insulin resistant subjects. At the completion of these studies, we expect to have detailed information on the potential therapeutic efficacy and the kinetic mechanism of action of combined treatment with n-3 FA and niacin. A better understanding of the action of these agents should lead to a clearer appreciation of the relationship between FFA flux and insulin resistance, to more effective therapy for the dyslipidemia of insulin resistance and ultimately to reduced risk for CAD in this burgeoning patient population.

Metabolic Syndrome Hypertriglyceridemia

triglycerides HDL-cholesterol insulin resistance omega-3 fatty acids niacin

null

4

arm 1: Dual placebo arm 2: niaspan arm 3: lovaza arm 4: combined therapy

[ 2, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 4 q qd intervention 2: 2 g qpm intervention 3: omacor placebo plus niaspan placebo intervention 4: 4 g qd intervention 5: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm

intervention 1: omega-3 acid ethyl esters intervention 2: extended release niacin intervention 3: placebo intervention 4: omega-3 acid ethyl esters intervention 5: combined treatment

1

Sioux Falls | South Dakota | United States | -96.70033 | 43.54997

0

NCT00286234

[ 0 ]

49

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication. The metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.

null

Schizophrenia Schizoaffective Disorder Bipolar Disorder

schizophrenia schizoaffective disorder bipolar disorder metabolic syndrome

null

2

arm 1: aripiprazole (Abilify) arm 2: ziprasidone (Geodon)

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: ziprasidone vs. aripiprazole dosed according to package insert intervention 2: aripiprazole vs. ziprasidone dosed according to package insert

intervention 1: ziprasidone vs. aripiprazole intervention 2: aripiprazole vs. ziprasidone

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00288366

[ 0 ]

20

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this research is to evaluate the usefulness of memantine, compared to placebo (sugar pill), for the treatment of cognitive impairment in patients with idiopathic Parkinson's disease (PD) and dementia. Memantine is used as a safe and effective treatment for patients with Alzheimer's disease. Cognitive impairment includes concentration and memory difficulties. We will look at how well this medication helps your cognitive impairment, how well you tolerate this medication (including its effects on your motor symptoms of PD) your activities of daily living, your emotions, and any medical conditions you might have. We will interview a person you choose as your "informant".

This is a randomized, placebo-controlled, parallel, double-blind 24-week prospective study of memantine at the dosage range 5-20 mg/day in 20 outpatients with idiopathic PD and dementia secondary to PD. Using the dosage escalation regimen approved for Alzheimer disease, subjects will start memantine or comparable placebo at 5 mg daily and advance 5 mg/week to 20 mg /day by week 4, with dosing at 10 mg bid. Subjects will undergo 7 clinical visits over the 6-month trial (Screen, Baseline/Week 0, and Weeks 4, 8, 14, 20, and 24). The dosage can be titrated downward in increments of 5 mg to a minimum dose of 5 mg/day in the event memantine is not tolerated at the scheduled dosages. This broad dose range is being used because 1)a favorable cognitive response may be evident at lower doses of memantine than recommended for AD and 2)adverse effects could emerge when typical AD dosing recommendations are used, as has been observed when treating PD patients with cholinesterase inhibitors. Subjects will remain on a stable dose of memantine/placebo after Week 8, unless precluded by adverse events. Ten subjects will be assigned to each treatment group. Randomization will be stratified according to whether subjects are taking a concomitant cholinesterase inhibitor. This will enable secondary group comparisons of treatment groups. Results from this initial small study will be used to evaluate the appropriateness of devising a larger-scale multi-site study of memantine for treatment of dementia in PD. The proposed assessment schedule was designed to represent use of memantine in general clinical practice and to minimize the burdens to caregivers and patients, who have impaired mobility as well as cognitive function.

Parkinson's Disease Cognitive Impairment Dementia

Parkinson's Disease Cognitive Impairment Dementia Memory

null

2

arm 1: Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance. arm 2: Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed. intervention 2: Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed.

intervention 1: Memantine intervention 2: Placebo Oral Tablet

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00294554

[ 5 ]

55

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.

Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer from depression. These individuals experience different symptoms than those who have depression alone. For example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. Depression treatment can help people with Parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. This study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with Parkinson's disease. Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. All participants will report to the study site at baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the Inventory of Depressive Symptomatology (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.

Depressive Disorder Parkinson Disease

Depression Parkinson's Disease Atomoxetine

null

2

arm 1: Participants will receive 40-80mgs of atomoxetine orally once daily. arm 2: Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 40 to 80 mg orally once daily for 8 weeks intervention 2: 40 to 80 mg orally once daily for 8 weeks

intervention 1: Atomoxetine intervention 2: Placebo

2

0

NCT00304161

[ 3, 4 ]

167

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

Lipoatrophy, the loss of body fat from particular areas of the body, is a common side effect of antiretroviral therapy (ART). The purpose of this study was to determine the effectiveness of uridine supplementation in treating HIV infected individuals on stable ART with lipoatrophy.

Lipoatrophy is a distressing long-term complication of ART and is associated with decreased quality of life, an increased risk of cardiovascular disease, and nonadherence to ART. The cause of lipoatrophy in HIV-infected individuals receiving ART is not completely understood. However, past research suggests that mitochondrial toxicity in subcutaneous adipose tissue caused by thymidine analogue nucleoside analogues may be responsible for the development of lipoatrophy. Uridine is a nucleoside that has been shown to be an effective supplement in treating individuals with mitochondrial toxicity. NucleomaxX is a food supplement that consists of mitocnol, a sugar cane extract that has a high content of nucleosides, including uridine. The purpose of this study was to evaluate the effects of uridine supplementation in the form of NucleomaxX on limb fat in HIV-infected individuals receiving stable ART containing stavudine (d4T) or zidovudine (ZDV). In addition, this study evaluated the safety and tolerability of NucleomaxX. This study lasted for 48 weeks. Participants were randomly assigned to one of two treatment arms, stratified by d4T or ZDV use. Arm A participants received NucleomaxX for uridine, while Arm B participants received a placebo for NucleomaxX. Participants in both arms received their assigned intervention three times per day, every other day, for the duration of the study. There were 8 study visits over the 48-week study duration. Blood collection and a physical exam occurred at all study visits, and participants completed an adherence assessment at most visits. Participants underwent dual energy X-ray absorptiometry scans (DEXA) within 14 days prior to or following the screening visit and at other selected visits. Specific fasting tests for glucose and lipid levels occurred at selected visits. ART was not provided by this study.

HIV Infections Lipoatrophy

Treatment Experienced Uridine

null

2

arm 1: Participants received NucleomaxX for 48 weeks arm 2: Participants received NucleomaxX placebo for 48 weeks

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 36 g sachet taken orally three times daily intervention 2: 36 g placebo sachet taken orally three times daily

intervention 1: NucleomaxX intervention 2: NucleomaxX placebo

30

0

NCT00307164

[ 3 ]

15

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment.

852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability.

Breast Cancer Ovarian Cancer Endometrial Cancer Cervical Cancer

Breast Ovarian Endometrial Cervical Metastatic 852A IRM Oncology Metastatic Cervical Cancer Metastatic Ovarian Cancer Metastatic Breast Cancer Metastatic Endometrial Cancer

null

2

arm 1: Patients treated with at least one dose - 852A subcutaneous injection. arm 2: Patients who received all 24 doses of 852A per protocol.

[ 0, 0 ]

1

[ 0 ]

intervention 1: 0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.

intervention 1: 852A

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00319748

[ 4 ]

68

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study treats patients with diffuse large B-cell lymphoma whose disease is in complete remission due to previous treatment with Cyclophosphamide Doxorubicin hydrochloride Vincristine Prednisolone- Rituximab (CHOP-R). Half of the patients received Zevalin and the other half receive no further anti-cancer treatment. The two patient groups compared to determine if Zevalin given after CHOP-R therapy provides greater benefits than receiving no additional anti-cancer therapy after CHOP-R.

The objectives of this study were to evaluate the efficacy and safety of the Zevalin study regimen compared with observation alone in patients with complete remission (CR or CRu) after first-line CHOP-R, the study was to include patients 60-years-of-age or older with histologically confirmed Ann Arbor stage II, III, or IV diffuse large B-cell lymphoma End Points: Primary endpoint: Overall survival (OS) Secondary endpoints: Disease-free survival (DFS), health-related quality of life (HRQL) as assessed by the patient using standard questionnaires . Number of Patients : A total of 400 patients (200 per arm) were planned to be enrolled. \- In fact, 68 randomized patients (full analysis set; FAS) were analysed; 34 patients per each arm. The per-protocol set (PPS; 65 patients) comprised 33 patients allocated to the Zevalin arm and 32 patients allocated to the observation control arm. Study Treatment : The combination regimen with rituximab was designed in 2 steps as follows: * Day 1: Initial administration of 250 mg/m\^2 rituximab, followed immediately by administration of 185 megabecquerel (MBq) (5 millicurie \[mCi\]) of \[111In\]-ibritumomab tiuxetan (the latter one only in centers where biodistribution imaging or dosimetry was compulsory according to local law). In centers where biodistribution imaging or dosimetry had not been required, the first rituximab infusion was given alone. * Day 7-9: Rituximab 250 mg/m\^2, followed immediately by \[90Y\]-ibritumomab tiuxetan 14.8 megabecquerel/kilograms (MBq/kg) (0.4 millicurie / kilogram \[mCi/kg\]) (maximum dose 1184 MBq) given as a slow intravenous (I.V.) push over 10 minutes. Two treatment days one week apart followed by a 12-week safety period. Duration of Patient Participation: Due to the sequential design, the total duration of this study was not fixed. Originally, the study was planned in a randomized, parallel-group, group sequential design. Objective : The primary objective of this study was an inferential comparison between the 2 randomized groups in terms of overall survival using a group sequential triangular test ,since the study was prematurely terminated the pre-planned group-sequential nature of the study design was not applicable statistical analyses. Actually, the prominent efficacy variables for the OS and DFS were analysed in the FAS (identical to the safety analysis set) and PPS using Kaplan Meier estimates by treatment group. Study Design : This study was designed as a prospective, multi-center, open label, randomized, two-armed, group-sequential Phase III study. The study was planned to consist of 2 stages: an interventional Stage 1 with Screening/Baseline, treatment, safety, and follow-up periods, and a non-interventional Stage 2 consisting of a long-term follow-up period (until completion of a median observation period of 5 years). This second stage of the study was to be started only if superiority of the Zevalin study regimen could be demonstrated in the preceding Stage 1. Pharmacokinetics/Pharmacodynamic results: Not applicable Extent of exposure: All 34 patients randomized to the Zevalin arm were given 2 rituximab infusions(with a median dose of 425.0 mg at each of the 2 infusion time points).Three patients underwent radioimaging studies/dosimetry and therefore were administered \[111In\]-ibritumomab tiuxetan at Day 1. All but 1 patient received an infusion with \[90Y\]-ibritumomab tiuxetan following the second infusion of rituximab. The mean dose ranged from 765.9 -1197.0 MBq.

Lymphoma, Large Cell, Diffuse

null

2

arm 1: Patients received Zevalin. Zevalin Therapeutic Regimen: Day 1: Initial administration of 250 mg/m\^2 rituximab, followed immediately by administration of 185 MBq of \[111In\]-ibritumomab tiuxetan ,in centers where centers where biodistribution imaging or dosimetry had not been required, the first rituximab infusion was given alone. \- Day 7-9: Rituximab 250 mg/m\^2, followed immediately by \[90Y\]-ibritumomab tiuxetan 14.8 MBq/kg given as a slow intravenous push over 10 minutes. Two treatment days one week apart were followed by a 12-week safety period. arm 2: Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse. This was non-interventional Stage consisting of a longterm follow-up period (until completion of a median observation period of 5 years).

[ 0, 4 ]

1

[ 0 ]

intervention 1: Zevalin study treatment regimen consisted of 2 rituximab i.v. infusions (Day 1 and Day 7-9) and one \[90Y\]-ibritumomab tiuxetan infusion in connection with the second rituximab infusion. The core treatment regimen in the Zevalin arm was: Day 1: Rituximab i.v. infusion 250 mg/m\^2 Day 7-to 9: Rituximab i.v. infusion 250 mg/m\^2 immediately followed by \[90Y\]-ibritumomab tiuxetan 14.8 MBq/kg (0.4 mCi/kg) with a maximum dose of 1184 MBq (32 mCi),administered as slow intravenous push over 10 minutes.

intervention 1: Zevalin

90

0

NCT00322218

[ 3 ]

358

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The investigators will conduct a randomized controlled trial comparing the use of nasal midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute seizure activity in children under the age of 18 years with epilepsy in the community setting. The primary hypothesis is that nasal midazolam will be more effective and have shorter seizure time compared to rectal diazepam in the community. The secondary hypotheses are that patients treated with nasal midazolam will have fewer respiratory complications, emergency department visits, and admissions.

Study Design: This is a prospective randomized controlled study. Study Procedures: Parents/guardians will be provided with a stopwatch to help record seizure times on the "Parent Form". All parents of children who have a seizure lasting longer than five minutes will be randomized to treat their seizure with the study medication (either rectal diazepam or nasal midazolam). If a parent treats a child with a study medication for seizure activity they are required to call "911". Families will be instructed to only give one dose of the study medication. If the seizure persists, EMS may give a second medication and transport the patient to the ED as per their established protocol. All parents/guardians who participate in this study will be asked to fill out a "Pre-study Form" (to be filled out during enrollment into the study) and a "Parent Form" for every seizure that is treated with the study medication. They will be given a stamped returned envelope to return the questionnaire. Once the study medication is used once, they will be done with the study. Any further need of home rescue medications to treat acute seizure activity will be coordinated by their neurologist. If questions arise, a study coordinator will be available by phone. In addition, parents/guardians will be contacted by phone every two months and questioned at clinic visits to audit compliance of reporting of seizures/hospitalizations, adverse events and answer any questions that arise. The study packet also instructs all families to call the study coordinator immediately if any expected or unexpected complication occurs. The study coordinator will be called on all ED visits and hospitalizations. We will then collect and analyze adverse events to compare them between the two groups. Any ER visit or hospitalization will be considered an adverse event and will be analyzed for its relationship to the seizure or medication. All adverse events will be reported to the IRB. See Table 1 for doses for the two study medications.

Seizures

null

2

arm 1: GIve once for seizure longer than 5 minutes arm 2: Given once for seizure longer than 5 minutes

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes. intervention 2: Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes.

intervention 1: Midazolam intervention 2: Diazepam

1

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

0

NCT00326612

[ 4 ]

581

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Study XP055 is a multicenter, open-label, 52-week extension study of XP13512 (Gabapentin Enacarbil \[GEn\]) given once daily to eligible subjects with Restless Legs Syndrome (RLS) who had previously completed 1 of the following studies and met eligibility criteria: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).

Restless Legs Syndrome

null

1

arm 1: 1200 mg XP13512, orally, once daily for 52 weeks

[ 0 ]

1

[ 0 ]

intervention 1: 1200 mg XP13512, orally, once daily for 52 weeks

intervention 1: XP13512 (GEn)

0

null

0

NCT00333359

[ 4 ]

75

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to determine whether aggressive acid suppression with Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors of response based on clinical and physiologic parameters.

Postnasal drip (PND) is a common complaint that brings patients to the attention of their primary care physicians. It is also one of the most common reasons for patients to seek care from otolaryngologists. Traditionally, PND has been considered and treated as a symptom of sinonasal pathology. It has also been shown, along with Gastroesophageal reflux disease (GERD) and asthma, to be a major contributor to the development of chronic cough. PND refractory to treatment aimed at sinonasal disease is sometimes treated with anti-GERD therapy. This treatment modality is based on clinical experience. To date, there are no studies in the literature to support a causal relationship between PND and extraesophageal reflux (EER). In a case control study of patients with and without esophagitis El-Serag et al reported a significant association (odds ratio 1.6, 95%CI 1.4-1.8) between sinusitis and GERD. A later study by Ulualp et al in 11 CT confirmed cases of chronic sinusitis resistant to therapy with conventional sinus therapies they found a significantly higher prevalence of hypopharyngeal acid exposure in the sinusitis group than controls. Recently, in an open label prospective pilot trial, DiBaise et al treated 11 patients with sinusitis and 19 GERD patients with omeprazole 20mg bid for 3-months. 9/11 sinusitis patients were found to have GERD by pH monitoring and there was moderate (25-89%) improvement in the sinus symptoms in the omeprazole treated group. However, there are currently no placebo-controlled trials assessing efficacy of PPI's in patients with PND.

Larynx Disease

null

2

arm 1: None arm 2: None

[ 1, 2 ]

5

[ 0, 3, 3, 0, 0 ]

intervention 1: 40 mg bid x 16 weeks intervention 2: 24 hour ph monitoring intervention 3: done prior to pH probe to measure length of esophagus intervention 4: 40mg bid intervention 5: one tablet bid

intervention 1: Lansoprazole Tablet intervention 2: PH and impedence testing intervention 3: manometry intervention 4: lansoprazole intervention 5: placebo

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00335283

[ 3 ]

140

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.

null

Methamphetamine

methamphetamine addiction

null

2

arm 1: Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. arm 2: After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Topiramate intervention 2: Placebo Oral Tablet

8

0

NCT00345371

[ 4 ]

240

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa.

Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of approximately 1 in 4,000. Patients typically report night blindness and difficulty with mid-peripheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients have reductions in central vision by 60 years if left untreated. Vitamin A palmitate, 15,000 International Units (IU)/d and an omega-3 rich diet have been shown to slow the progression of this condition among adults with the typical forms.(see Archives of Ophthalmology,111:761-772,1993 ; Archives of Ophthalmology 122: 1306-1314, 2004; Archives of Ophthalmology 130(6):701-711,2013). The present study was a randomized, controlled, double-masked trial with a planned duration of 5 years.Two hundred and forty adults with the typical forms of RP were assigned to either lutein 12mg/d or a control group. Patients in both groups received 15,000 IU/day of vitamin A palmitate in addition to the supplement under study. Participants agreed not to know the contents of the supplement or their group assignment until the end of the trial. The main outcome measurement was the total point score for the 30-2 program of the Humphrey Field analyzer (HFA). In addition,the total point score for the 60-4 program ,the total point score of the 30-2 and 60-4 programs combined, computer-averaged 30-Hz cone Electroretinogram (ERG) amplitude and Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity were measured annually as secondary endpoints.

Retinitis Pigmentosa

Retinitis Pigmentosa, Inherited Retinal Degeneration

null

2

arm 1: Daily intake of 12mg of Lutein plus 15,000 IU/d of Vitamin A palmitate arm 2: Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate

[ 0, 2 ]

2

[ 0, 7 ]

intervention 1: 12mg/d intervention 2: Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate

intervention 1: Lutein intervention 2: Cornstarch control

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00346333

[ 3 ]

139

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).

null

Coronary Arteriosclerosis Acute Coronary Syndrome

null

3

arm 1: Open label (lead-in) dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. arm 2: Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days. arm 3: Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.

[ 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 10 mg tablet taken orally intervention 2: 75 mg tablet taken orally intervention 3: oral, as blinding mechanism. intervention 4: 60 mg (six 10-mg tablets) taken orally intervention 5: oral, as blinding mechanism

intervention 1: prasugrel 10 mg intervention 2: clopidogrel intervention 3: prasugrel placebo intervention 4: prasugrel 60 mg intervention 5: clopidogrel placebo

9

0

NCT00356135

[ 3 ]

55

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).

null

Acute Myeloid Leukemia

Acute Myeloid Leukemia AML Decitabine Dacogen MGI PHARMA, INC.

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 20 mg/m\^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.

intervention 1: Decitabine

3

0

NCT00358644

[ 0 ]

411

RANDOMIZED

PARALLEL

1PREVENTION

1SINGLE

false

0ALL

true

Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH.

Patients undergoing total hip arthroplasty surgery are at particular risk for Thromboembolic disease. To date two prophylactic modalities are being used: mechanical (intermittent pneumatic compression \[IPC\]) and pharmacological (anticoagulant). Both are effective; however each carries its own advantages and disadvantages. The purpose of this study is to compare in total hip arthroplasty (THA) patients the safety and effectiveness of the mobile ActiveCare CECT based prophylaxis protocol and compare it with LMWH standard of care protocol for this patient population. The protocol is based upon the CECT system as the primary DVT prophylaxis method (with or without the addition of low dose baby aspirin \[81 mg\]).

Deep Vein Thrombosis of Lower Limb Pulmonary Embolism (PE) Bleeding

SAFE CECT SFT ActiveCare ActiveCare+SFT Deep Vein Thrombosis prevention Total Hip Replacement Total Hip Arthroplasty Low Molecular Weight Heparin MCS

null

2

arm 1: The ActiveCare CECT device is a mobile compression device used to prevent venous thromboembolic events, used after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. arm 2: Enoxaparin (LMWH) will be used, following a protocol that is considered a standard of care for this patient population. 40mg QD for the remainder of the 10 days.

[ 0, 1 ]

2

[ 1, 0 ]

intervention 1: Patients will be treated with the ActiveCare+ CECT device starting after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. Baby aspirin (81 mg) QD can be added (depending on surgeon preference) 12-24 hours after surgery. Post discharge prophylaxis is the same for the remainder of the 10-12 days. Patients will wear the device to the duplex ultrasound when it will be discontinued by nurse. intervention 2: Patients will be treated with Enoxaparin (Lovenox) for a total of 10 days beginning with 30mg BID starting 12-24 hours after surgery and continued until hospital discharge. Post discharge prophylaxis will be Enoxaparin 40mg QD for the remainder of the 10 days.

intervention 1: ActiveCare CECT device intervention 2: Enoxaparin

9

0

NCT00358735

[ 4 ]

72

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram).

Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain. It often takes several weeks to find out if an antidepressant medication is going to work for someone. This research study aims to identify tests that are able to predict if a medication will work, even before a person starts to feel better. The first test is a measurement of the blood protein Brain-Derived Neurotrophic Factor (BDNF), which is involved with brain cell growth. The second test is a Quantitative Electroencephalogram (QEEG), which measures brain activity. The study lasts for 8 weeks and involves 5 total visits to the clinic. Throughout the study, all subjects will receive either escitalopram (Lexapro) or citalopram (Celexa) on the basis of the study doctor's clinical judgment. The dose of the medications can be increased at any point in time if the study doctor thinks it is appropriate. After the first screen visit (which lasts about 3 hours), each subsequent half-hour visit will involve a 2-tablespoon blood draw to measure BDNF levels, as well as a QEEG in which small, painless electrodes are stuck to the subject's forehead and electrical activity of the brain is measured. At the end of the 8 weeks, subjects are offered 3 months of free follow-up care, including medications.

Major Depressive Disorder

depression biology

null

1

arm 1: citalopram or escitalopram

[ 5 ]

1

[ 0 ]

intervention 1: Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.

intervention 1: open-label selective serotonin reuptake inhibitor (SSRI)

0

null

0

NCT00361218

[ 5 ]

22

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

People with high fasting glucose can develop type 2 diabetes with the passage of time. This study is being done to determine the effect of a novel medication in people with this elevated fasting glucose. Sitagliptin is a substance that raises levels of a hormone normally found in the blood. This hormone, called glucagon-like peptide-1 (GLP-1), is normally released by the intestine in response to the presence of food. This hormone acts like a messenger between the intestine and the pancreas to raise insulin levels, and therefore, lower blood sugars. Sitagliptin is effective in people with diabetes, however, this study is being done to determine if Sitagliptin is effective in people with high fasting glucose who do not yet have diabetes.

Impaired fasting glucose (IFG) confers a high risk of progression to diabetes. Its pathogenesis has been an area of active investigation, with defects in insulin and glucagon secretion as well as insulin action likely to play a role. Several studies have suggested that the prediabetic and diabetic state are associated with alterations in circulating incretin concentrations. More recently, a large study of non-diabetic individuals demonstrated decreased GLP-1 concentrations after a glucose challenge in individuals with prediabetes but concluded that defects in GLP-1 secretion were unrelated to insulin secretion. In impaired glucose tolerance (IGT), defects in incretin-induced insulin secretion coexist with defects in glucose induced insulin secretion. Worsening degrees of glucose tolerance are associated with decreased insulin secretion for the prevailing insulin action. Moreover early glucagon suppression is impaired in IGT. Since GLP-1 is an insulin secretagogue and suppresses glucagon, it is conceivable that defects in GLP-1 secretion could contribute to the pathogenesis of pre-diabetes. Inhibition of Dipeptidyl Peptidase-4 (DPP-4), an enzyme which rapidly degrades the incretin hormones, has been shown to be a useful therapeutic strategy in type 2 diabetes. DPP-4 inhibitors increase (model-calculated) insulin secretion and decrease glucagon concentrations resulting in a lowering of fasting (and postprandial) glucose concentrations in people with type 2 diabetes. Their effects in people with IFG are less certain. However, DPP-4 inhibitors provide an opportunity to directly examine the contribution of abnormal incretin concentrations to the pathogenesis of IFG, by raising concentrations of endogenous incretin hormones. The current experiments tested this hypothesis by measuring insulin secretion and action and fasting and postprandial glucose turnover before and after 8 weeks of therapy with a DPP-4 inhibitor.

Pre-diabetes

null

2

arm 1: People with impaired fasting glucose randomized to treatment with sitagliptin 100 mg once daily. arm 2: People with impaired fasting glucose randomized to treatment with placebo once daily.

[ 1, 2 ]

2

[ 0, 10 ]

intervention 1: 100 mg once daily intervention 2: once daily for duration of the study

intervention 1: Sitagliptin intervention 2: Placebo

1

Rochester | Minnesota | United States | -92.4699 | 44.02163

0

NCT00364377

[ 3 ]

25

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The strategy for combining therapeutic agents in cancer treatments has been successful in multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways involved in tumor growth. Nonclinical studies have demonstrated that the combination of bevacizumab and erlotinib results in greater efficacy than either agent alone. Furthermore, because there is little to no overlap in toxicity profile between the two agents, the combination is expected to be well tolerated and may provide even greater benefit for patients who are unable to receive cytotoxic therapy.

OUTLINE: This is a multi-center study. * Bevacizumab 15 mg/kg IV on day 1 * Erlotinib 150 mg po qd days 1-21 * Disease Assessment during even numbered cycles If no progressive disease observed, continue (combination or single agent- see below) until unacceptable toxicity or progressive disease. If progressive disease observed, treatment will be discontinued. * Cycles will be repeated every 21 days up to a total of 6 cycles. * Patients with non-progression after 6 cycles may stay on therapy (single agent erlotinib or the combination) until progressive disease or intolerable toxicity (at the physician discretion). * Patients who require discontinuation of bevacizumab may receive at investigator's discretion erlotinib alone on study until progression. * Patients who require discontinuation of erlotinib may receive at investigator's discretion bevacizumab alone until progression. ECOG Performance Status 2 Hematopoietic: * Absolute neutrophil count (ANC) \> 1,000 mm3 * Platelet count \> 100,000 mm3 * Hemoglobin \> 8 g/dl Hepatic: * Bilirubin \< 2 X upper limit of normal. * Aspartate aminotransferase (AST, SGOT) \< 2.5 X upper limit of normal or 5 X if liver involvement. Renal: * Urine protein:creatinine ratio 1.0 at screening Cardiovascular: * Blood pressure of \< 150/100 mmHg. * No history of unstable angina. * No history of New York Heart Association (NYHA) Grade II or greater congestive heart failure. * No history of myocardial infarction within 6 months prior to registration for protocol therapy. * No history of stroke within 6 months prior to registration for protocol therapy. * No clinically significant peripheral vascular disease.

Lung Cancer

null

1

arm 1: Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Erlotinib 150 mg qd days 1-21 intervention 2: Bevacizumab 15 mg/kg IV, day 1

intervention 1: Erlotinib intervention 2: Bevacizumab

13

0

NCT00367601

[ 3 ]

71

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT).

This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT. The study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid IMT, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.

HIV Infections

mitochondria HIV lipoatrophy

null

2

arm 1: Rosiglitazone active 4 mg BID arm 2: Matching Placebo BID

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Rosiglitazone 4mg BID intervention 2: Placebo for rosiglitazone

intervention 1: Rosiglitazone intervention 2: Placebo

2

0

NCT00367744

[ 5 ]

228

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

null

This study is designed to evaluate whether tacrolimus dose reduction in de novo renal recipients receiving everolimus can preserve renal function while maintaining efficacy.

null

Renal Transplantation

null

2

arm 1: The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice. arm 2: The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.

[ 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None

intervention 1: Everolimus (RAD001) intervention 2: Tacrolimus intervention 3: Basiliximab intervention 4: Corticosteroids

1

Basel | N/A | Switzerland | 7.57327 | 47.55839

0

NCT00369161

[ 4 ]

128

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

null

0ALL

null

This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA (mycophenolic acid) exposure of ≥ 40 mg\*h/L compared to a standard dosing regimen of EC-MPS. Additionally, this study will assess safety and tolerability of the intensified dosing regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).

null

Renal Transplantation

Renal transplantation, mycophenolate

null

2

arm 1: Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 180 days. arm 2: Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 6 months.

[ 0, 1 ]

1

[ 0 ]

intervention 1: Tablets for oral administration

intervention 1: Enteric-coated mycophenolate sodium (EC-MPS)

1

Various Cities | N/A | Germany | N/A | N/A

0

NCT00369278

[ 4 ]

548

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-one (21) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined, followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by one (1) week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication acetaminophen (up to 4 grams per day) will be allowed.

Fibromyalgia

FMS Fibro pain Body pain tenderness joint pain stiffness muscular pain

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: two doses intervention 2: Oral Solution

intervention 1: Xyrem® intervention 2: Placebo

70

0

NCT00371137

[ 0 ]

32

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a contributing feature. Botox relaxes the pylorus so that food can empty the stomach more rapidly. Lesser quality studies have shown that this treatment works in about 40% of patients, and relieves symptoms for up to 3 months. This study compares this treatment to placebo (saline) injection. After a 1 month period patients may elect to receive open label botox who have not received relief from their first injection. Patients symptoms and gastric emptying are followed for 1 year.

Patients with gastroparesis, or delayed gastric emptying, present with early satiety, postprandial bloating, nausea, vomiting, and abdominal pain or discomfort.1 Gastric emptying is a highly regulated process reflecting the integration of propulsive forces generated by proximal fundic tone and distal antral contractions with the resistance of the pyloric sphincter. Antral hypomotility as well as increased gastric outlet resistance due to pyloric dysfunction or pylorospasm appear to be important physiologic disturbances in gastroparesis.2-4 Current treatment for gastroparesis employs prokinetic agents that increase antral contractility and accelerate gastric emptying.5 Unfortunately, prokinetic agents have limited efficacy and trials of these agents have suffered from significant methodological flaws.6 Troublesome side effects such as cardiac arrhythmias in the case of cisapride (Propulsid, Janssen Pharmaceutica) and extrapyramidal symptoms and sedation in the case of metoclopramide (Reglan, A.H. Robins) have limited the usefulness of these agents.7 Domperidone may be effective for treating symptoms of gastroparesis, however it is unavailable in the U.S.8 Botulinum toxin (Botox, Allergan) is an inhibitor of cholinergic neuromuscular transmission and has been used to treat spastic disorders of both striated and smooth muscles by local injection into affected muscles.9 Previous published work from our institution demonstrated that injection of botulinum toxin into the pylorus improved gastric emptying and reduces symptoms in idiopathic gastroparesis.10 In our open label study, patients had a 38% reduction in gastroparesis symptoms when interviewed 4 weeks after injection. Seventy percent of patients had improved gastric emptying. No immediate or short term (within 6 months) untoward events occurred in our study. The beneficial effect of botulinum toxin injection was suggested to be through decreasing pyloric resistance; however, manometric analysis of this region was not performed. Our results are similar to those seen in other studies that have demonstrated accelerated gastric emptying in response to pyloric botulinum toxin injection.11-13 These studies have included groups of patients with both idiopathic and diabetic gastroparesis. Unfortunately, in all studies, the patient groups have been very small and the study design has been open label that might bias results in favor of a positive response. In addition, follow-up has been for only 6 months. Despite limited data, many gastroenterologists are now using botulinum toxin injection for the treatment of gastroparesis outside the context of clinical research studies. We are concerned that this practice may be increasing nationwide without definitive proof of efficacy. A randomized, placebo-controlled trial is necessary to establish the usefulness of pyloric botulinum toxin injection for gastroparesis. Botulinum toxin therapy is expensive and may not be efficacious. In addition, if efficacious, the mechanism by which botulinum toxin improves gastric emptying needs to be studied. This research protocol will answer several questions concerning this potentially useful therapy for gastroparesis.

Gastroparesis

gastroparesis vomiting nausea bloating dyspepsia

null

2

arm 1: 200 U of Botox injected endoscopically into pylorus arm 2: saline into pylorus.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 200 U given by injection into the pylorus. intervention 2: saline injection into pylorus.

intervention 1: Botulinum toxin A intervention 2: Placebo

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00372970

[ 3 ]

15

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This trial is designed to explore a modified dose and schedule of azacitidine in order to more effectively address the needs of patients with low-risk myelodysplastic syndromes (MDS), i.e., to alter the natural history of the disease without excessive toxicity or burden. The administration of erythropoietin is designed to influence the differentiation of primitive hematopoietic cells in which azacitidine has reversed the abnormal phenotype to red blood cells for patients in whom inadequate production of red blood cells is the major clinical issue.

OUTLINE: This is an open label, multi-center, randomized study. Eligible patients will be randomized to one of two treatment arms: Arm A (Azacitidine + Erythropoietin) * Azacitidine Treatment 50 mg/m2 subcutaneously every other day (three times a week) for two consecutive weeks every four weeks. A cycle of therapy is defined as two consecutive weeks of subcutaneous azacitidine administered every other day three times a week (e.g. Monday - Wednesday - Friday) and the time to resolution of any treatment associated toxicity. * Erythropoietin Treatment Patients who are randomized to Arm A will receive a dose of 60,000IU as a single subcutaneous injection weekly without interruption while enrolled on protocol therapy. The dose should be administered to coincide with the first day of each cycle. * Protocol therapy may be administered for up to six cycles of therapy. Arm B (Azacitidine Alone) * Azacitidine Treatment 50 mg/m2 subcutaneously every other day (three times a week) for two consecutive weeks every four weeks. A cycle of therapy is defined as two consecutive weeks of subcutaneous azacitidine administered every other day three times a week (e.g. Monday - Wednesday - Friday) and the time to resolution of any treatment associated toxicity. * Protocol therapy may be administered for up to six cycles of therapy. ECOG performance status 0 to 2 Hematopoietic: To be eligible for randomization, subjects must have documentation of at least 1 of the following: * A transfusion dependent anemia (defined by a history of two or more episodes of transfusion within a period of 8 weeks). * An untransfused hemoglobin \< 10 gm/dl measured on at least two occasions more than 7 days apart in the month prior to randomization. Patients must also meet 1 of the following criteria: * Has not received prior erythropoietin and has a serum erythropoietin level \> 200 IU/L within 14 days of randomization. * Has received prior erythropoietin without clinical benefit in the judgment of the treating physician. * Adequate iron status defined as serum ferritin \> 20 ng/ml and transferrin saturation of \> 30% within 90 days prior to randomization. * Symptoms attributed to the anemia with hemoglobin \< 11 g/dL. * Folate and Vitamin B12 levels within normal limits within 90 days prior to randomization. Hepatic: * SGOT (ALT) level \< 2 x ULN within 14 days prior to randomization. * SGPT (AST) level \< 2 x ULN within 14 days prior to randomization. * Serum total bilirubin level \< 2 x ULN within 14 days prior to randomization. Renal: * Serum creatine \< 1.5 x the upper limit of normal (ULN) within 14 days prior to randomization. Cardiovascular: * No uncontrolled hypertension (defined as a systolic pressure \> 160 mmHg and/or a diastolic pressure \> 110 mmHg). * No history of (within 12 months) deep venous thrombosis (DVT), pulmonary embolism (PE), or other venous thrombosis. Prior superficial thrombophlebitis is not an exclusion criterion. * No history of (within 6 months) cerebrovascular accident (\[CVA\] includes ischemic, embolic, and hemorrhagic), transient ischemic attack (TIA), myocardial ischemia (includes Unstable Angina, Q wave Myocardial Infarction \[QwMI\], and non-Q wave Myocardial Infarction \[NQMI\]), or other arterial thrombosis.

Myelodysplastic Syndromes

null

2

arm 1: Azacitidine + Erythropoietin arm 2: Azacitidine

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks. intervention 2: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy intervention 3: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.

intervention 1: Azacitidine intervention 2: Erythropoietin intervention 3: Azacitidine (Monotherapy)

9

0

NCT00379912

[ 4 ]

150

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37 centers in the United States. 150 subjects ≥ 16 years of age who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.

null

Dysfunctional Hemodialysis Catheters

HD Hemodialysis Catheter clearance TNKase Renal Insufficiency

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase intervention 2: For the initial treatment, 2 mL of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase

intervention 1: placebo intervention 2: tenecteplase

0

null

0

NCT00396032

[ 5 ]

30

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses will be tested: Hypothesis 1: treatment ( 3 weeks) of divalproex extended-release is similar to quetiapine in the symptomatic control of mania or mixed mania Hypothesis 2: divalproex extended-release orally loaded may produce significant improvements in symptoms of mania sooner than quetiapine Hypothesis 3: divalproex extended-release may produce significantly less sedation

This will be a rater-blinded, head-to-head comparison (no placebo) of divalproex ER and quetiapine in patients with symptoms of an active manic or mixed mania (symptoms of mania and depression). Forty subjects are expected to be enrolled. After screening for eligibility, eligible subjects will be randomized while hospitalized in a 1:1 ratio into 2 treatment groups: divalproex ER or quetiapine. Depakote® ER will be given orally at 30 mg/kg day initially taken at night and rounded up to nearest 500 mg dose with adjustments made through the trial as needed to obtain serum valproic acid levels of 85-125 mcg/ml. Quetiapine will be given orally at an initial dose of 200mg/day on Day 1, and titrate up to 800 mg/day. The duration of the study will be 21 days from baseline and the total number of visits including screening is five. Patients will be released from the hospital once stable and visits for the study will then take place on an outpatient basis.

Bipolar Disorder

quetiapine divalproex

null

2

arm 1: Divalproex ER arm 2: quetiapine fumarate

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Dose: 30mg per kg, rounded to nearest 500mg, dosed PO QHS. Adjustments made through trial to obtain serum valproic acid levels of 85-125 mcg/ml intervention 2: Dose: 200mg PO QHS, titrated up to therapeutic dose of 600-800mg.

intervention 1: divalproex ER intervention 2: quetiapine

1

San Diego | California | United States | -117.16472 | 32.71571

0

NCT00397020

[ 4 ]

66

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

false

0ALL

true

This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia. Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.

Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. Moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.

Hodgkin Disease Non-Hodgkin Lymphoma Multiple Myeloma Bacteremia

prophylaxis bacteremia moxifloxacin stem cell transplantation Hodgkin disease non-Hodgkin lymphoma multiple myeloma solid tumor autologous stem cell transplantation

null

2

arm 1: moxifloxacin 400 mg tablets once daily arm 2: identical appearing placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 400 mg p.o. per day intervention 2: one tablet per day p.o.

intervention 1: moxifloxacin intervention 2: placebo

1

Cologne | N/A | Germany | 6.95 | 50.93333

0

NCT00398411

[ 4 ]

1,271

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The primary objective of this phase III clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of the combination of mefloquine plus artesunate (MQ + AS) in children and adults with uncomplicated P falciparum malaria in South East Asia, India and Africa.

This is a multi-centre, comparative, randomised, open-label, parallel-group, non-inferiority study comparing the efficacy and safety of a fixed combination of PA to a loose combination of MQ + AS for patients with acute, symptomatic, uncomplicated P. falciparum malaria. The study population will include 1271 patients, comprising male and female children (≥20 kg body weight) and adults, recruited from study sites in South East Asia, India and Africa. Patients will be randomised in a 2:1 ratio to receive either oral PA (180:60mg tablets) or MQ (250mg tablets) plus AS (100mg tablets) once a day for 3 consecutive days (Days 0, 1, and 2). The study drug will be administered by a Third-Party Investigator unblinded to the study treatment, while the Investigator remains blinded. Patients will be confined to the to the study facility for ≥4 days (Days 0, 1, 2, and 3) and remain near the study site for ≥7 days, or once fever and parasite clearance has been confirmed for ≥24 hours - whichever occurs later. The primary efficacy end point for the study is the proportion of patients with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28. Scheduled follow-up visits will continue until completion of the study at Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event. The primary efficacy end point for the study is the proportion of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28 (defined as the absence of parasitaemia without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure). Scheduled follow-up visits will continue until completion of the study at Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.

Falciparum Malaria

malaria antimalarial P falciparum pyronaridine artesunate artemisinin based combination therapy (ACT) pyronaridine artesunate (Pyramax)

null

2

arm 1: Oral pyronaridine artesunate (180:60mg tablets) once a day for 3 consecutive days (Day 0, 1, and 2). Posology based on body weight ranges. arm 2: Mefloquine (250mg tablets) plus artesunate (100mg tablets) once a day for 3 consecutive days (Day 0, 1, and 2). Posology based on body weight ranges.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: once a day for 3 days intervention 2: once a day for 3 days

intervention 1: Pyronaridine - artesunate intervention 2: Mefloquine plus artesunate

9

0

NCT00403260

[ 5 ]

1,121

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco® or usual care.

null

Asthma

Asthma Alvesco® Ciclesonide

null

2

arm 1: Alvesco 320mcg / Alvesco 640mcg arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Asthma Care with Alvesco intervention 2: Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment

intervention 1: Ciclesonide intervention 2: Usual Care Inhaled Glucocorticosteroids

186

Abbotsford | N/A | Canada | -122.25257 | 49.05798 Ajax | N/A | Canada | -79.03288 | 43.85012 Alma | N/A | Canada | -71.6491 | 48.55009 Anjou | N/A | Canada | -73.54917 | 45.60008 Anjou | N/A | Canada | -73.54917 | 45.60008 Barrie | N/A | Canada | -79.66634 | 44.40011 Brampton | N/A | Canada | -79.76633 | 43.68341 Brampton | N/A | Canada | -79.76633 | 43.68341 Brampton | N/A | Canada | -79.76633 | 43.68341 Brampton | N/A | Canada | -79.76633 | 43.68341 Brampton | N/A | Canada | -79.76633 | 43.68341 Brossard | N/A | Canada | -73.46583 | 45.45008 Burnaby | N/A | Canada | -122.95263 | 49.26636 Burnaby | N/A | Canada | -122.95263 | 49.26636 Cacouna | N/A | Canada | -69.50054 | 47.91657 Calgary | N/A | Canada | -114.08529 | 51.05011 Calgary | N/A | Canada | -114.08529 | 51.05011 Calgary | N/A | Canada | -114.08529 | 51.05011 Calgary | N/A | Canada | -114.08529 | 51.05011 Calgary | N/A | Canada | -114.08529 | 51.05011 Calgary | N/A | Canada | -114.08529 | 51.05011 Calgary | N/A | Canada | -114.08529 | 51.05011 Calgary | N/A | Canada | -114.08529 | 51.05011 Cambridge | N/A | Canada | -80.31269 | 43.3601 Collingwood | N/A | Canada | -80.21638 | 44.4834 Conception Bay S | N/A | Canada | N/A | N/A Cornwall | N/A | Canada | -74.72815 | 45.01809 Corunna | N/A | Canada | -82.43313 | 42.88338 Courcelette | N/A | Canada | N/A | N/A Delta | N/A | Canada | -122.9068 | 49.14399 Delta | N/A | Canada | -122.9068 | 49.14399 Dolbeau-Mistassini | N/A | Canada | -72.23142 | 48.8786 Edmonton | N/A | Canada | -113.46871 | 53.55014 Etobicoke | N/A | Canada | -79.56985 | 43.64415 Fort Erie | N/A | Canada | -78.93286 | 42.90012 Gatineau | N/A | Canada | -75.70164 | 45.47723 Gatineau | N/A | Canada | -75.70164 | 45.47723 Gatineau | N/A | Canada | -75.70164 | 45.47723 Gatineau | N/A | Canada | -75.70164 | 45.47723 Gatineau | N/A | Canada | -75.70164 | 45.47723 Gatineau | N/A | Canada | -75.70164 | 45.47723 Gatineau (Sector Hull) | N/A | Canada | -75.70164 | 45.47723 Grand Falls | N/A | Canada | -67.74179 | 47.04609 Greater Sudbury | N/A | Canada | -80.99001 | 46.49 Greater Sudbury | N/A | Canada | -80.99001 | 46.49 Halifax | N/A | Canada | -63.57688 | 44.64269 Harrow | N/A | Canada | -82.91654 | 42.03339 Hastings | N/A | Canada | -64.85081 | 44.64922 Hull | N/A | Canada | -75.74105 | 45.4445 Hull | N/A | Canada | -75.74105 | 45.4445 Joliette | N/A | Canada | -73.4236 | 46.0164 Joliette | N/A | Canada | -73.4236 | 46.0164 Jonquière | N/A | Canada | -71.24884 | 48.41648 Kamloops | N/A | Canada | -120.3192 | 50.66648 Kentville | N/A | Canada | -64.49605 | 45.0771 Keswick | N/A | Canada | -79.46632 | 44.25011 Kingston | N/A | Canada | -76.48098 | 44.22976 Kirkland | N/A | Canada | -73.86586 | 45.45008 LaSalle | N/A | Canada | -83.06095 | 42.24481 LaSalle | N/A | Canada | -83.06095 | 42.24481 Laval | N/A | Canada | -73.692 | 45.56995 London | N/A | Canada | -81.23304 | 42.98339 London | N/A | Canada | -81.23304 | 42.98339 London | N/A | Canada | -81.23304 | 42.98339 Milton | N/A | Canada | -79.88294 | 43.51681 Mississauga | N/A | Canada | -79.6583 | 43.5789 Mississauga | N/A | Canada | -79.6583 | 43.5789 Mississauga | N/A | Canada | -79.6583 | 43.5789 Mississauga | N/A | Canada | -79.6583 | 43.5789 Mississauga | N/A | Canada | -79.6583 | 43.5789 Mississauga | N/A | Canada | -79.6583 | 43.5789 Moncton | N/A | Canada | -64.7965 | 46.09454 Montreal | N/A | Canada | -73.58781 | 45.50884 Montreal | N/A | Canada | -73.58781 | 45.50884 Montreal | N/A | Canada | -73.58781 | 45.50884 Montreal | N/A | Canada | -73.58781 | 45.50884 Montreal | N/A | Canada | -73.58781 | 45.50884 Montreal | N/A | Canada | -73.58781 | 45.50884 Montreal | N/A | Canada | -73.58781 | 45.50884 Montreal | N/A | Canada | -73.58781 | 45.50884 Mount Pearl | N/A | Canada | -52.78135 | 47.51659 Mount Pearl | N/A | Canada | -52.78135 | 47.51659 Niagara Falls | N/A | Canada | -79.06627 | 43.10012 North Bay | N/A | Canada | -79.46633 | 46.3168 North Sydney | N/A | Canada | -60.25489 | 46.20777 North Vancouver | N/A | Canada | -123.06934 | 49.31636 North Vancouver | N/A | Canada | -123.06934 | 49.31636 North Vancouver | N/A | Canada | -123.06934 | 49.31636 North York | N/A | Canada | N/A | N/A Oakville | N/A | Canada | -79.68292 | 43.45011 Oshawa | N/A | Canada | -78.84957 | 43.90012 Oshawa | N/A | Canada | -78.84957 | 43.90012 Ottawa | N/A | Canada | -75.69812 | 45.41117 Ottawa | N/A | Canada | -75.69812 | 45.41117 Ottawa | N/A | Canada | -75.69812 | 45.41117 Penticton | N/A | Canada | -119.58584 | 49.48062 Penticton | N/A | Canada | -119.58584 | 49.48062 Perth-Andover | N/A | Canada | -67.70393 | 46.73551 Point Edward | N/A | Canada | -60.27664 | 46.16271 Pointe-Claire | N/A | Canada | -73.81669 | 45.44868 Princeville | N/A | Canada | -71.87462 | 46.17163 Québec | N/A | Canada | -71.21454 | 46.81228 Québec | N/A | Canada | -71.21454 | 46.81228 Québec | N/A | Canada | -71.21454 | 46.81228 Red Deer | N/A | Canada | -113.802 | 52.26682 Regina | N/A | Canada | -104.6178 | 50.45008 Regina | N/A | Canada | -104.6178 | 50.45008 Repentigny | N/A | Canada | -73.45008 | 45.74222 Richmond | N/A | Canada | -123.13683 | 49.17003 Richmond Hill | N/A | Canada | -79.43725 | 43.87111 Rimouski | N/A | Canada | -68.52396 | 48.44879 Roxton Pond | N/A | Canada | -72.66582 | 45.48338 Saint John | N/A | Canada | -66.05616 | 45.27076 Saint Romuald | N/A | Canada | -71.23921 | 46.75818 Saint-Bruno | N/A | Canada | -71.6491 | 48.46679 Saint-Jérôme | N/A | Canada | -74.00365 | 45.78036 Saint-Léonard | N/A | Canada | -73.59501 | 45.58773 Saint-Pie | N/A | Canada | -72.9089 | 45.50277 Sainte-Catherine | N/A | Canada | -73.58248 | 45.40008 Sarnia | N/A | Canada | -82.40407 | 42.97866 Saskatoon | N/A | Canada | -106.66892 | 52.13238 Saskatoon | N/A | Canada | -106.66892 | 52.13238 Scarborough | N/A | Canada | -96.0 | 60.0 Scarborough | N/A | Canada | -96.0 | 60.0 Sherbrooke | N/A | Canada | -71.89908 | 45.40008 Shubenacadie | N/A | Canada | -63.39869 | 45.08345 St-Jean-sur-Richel | N/A | Canada | N/A | N/A St. Catharines | N/A | Canada | -79.24267 | 43.17126 St. John's | N/A | Canada | -52.70931 | 47.56494 St. John's | N/A | Canada | -52.70931 | 47.56494 St. John's | N/A | Canada | -52.70931 | 47.56494 St. John's | N/A | Canada | -52.70931 | 47.56494 Ste Anne de Bellev | N/A | Canada | N/A | N/A Stirling | N/A | Canada | -77.54948 | 44.30012 Stouffville | N/A | Canada | -79.2496 | 43.96682 Surrey | N/A | Canada | -122.82509 | 49.10635 Surrey | N/A | Canada | -122.82509 | 49.10635 Surrey | N/A | Canada | -122.82509 | 49.10635 Surrey | N/A | Canada | -122.82509 | 49.10635 Surrey | N/A | Canada | -122.82509 | 49.10635 Sydney Mines | N/A | Canada | -60.21767 | 46.23669 Thetford-Mines | N/A | Canada | -71.30539 | 46.09371 Thornhill | N/A | Canada | -63.61147 | 44.60347 Thunder Bay | N/A | Canada | -89.25018 | 48.38202 Thunder Bay | N/A | Canada | -89.25018 | 48.38202 Toronto | N/A | Canada | -79.39864 | 43.70643 Toronto | N/A | Canada | -79.39864 | 43.70643 Toronto | N/A | Canada | -79.39864 | 43.70643 Toronto | N/A | Canada | -79.39864 | 43.70643 Toronto | N/A | Canada | -79.39864 | 43.70643 Toronto | N/A | Canada | -79.39864 | 43.70643 Toronto | N/A | Canada | -79.39864 | 43.70643 Toronto | N/A | Canada | -79.39864 | 43.70643 Toronto | N/A | Canada | -79.39864 | 43.70643 Vancouver | N/A | Canada | -123.11934 | 49.24966 Vancouver | N/A | Canada | -123.11934 | 49.24966 Vancouver | N/A | Canada | -123.11934 | 49.24966 Vancouver | N/A | Canada | -123.11934 | 49.24966 Vancouver | N/A | Canada | -123.11934 | 49.24966 Verdun | N/A | Canada | -73.57058 | 45.46005 Verdun | N/A | Canada | -73.57058 | 45.46005 Victoria | N/A | Canada | -123.35155 | 48.4359 West Vancouver | N/A | Canada | -123.16019 | 49.3286 Westmount | N/A | Canada | -73.59918 | 45.48341 Whitby | N/A | Canada | -78.93287 | 43.88342 Windsor | N/A | Canada | -83.01654 | 42.30008 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Woodstock | N/A | Canada | -80.7497 | 43.13339 Woodstock | N/A | Canada | -80.7497 | 43.13339 York | N/A | Canada | -63.09868 | 46.31682 York | N/A | Canada | -63.09868 | 46.31682

0

NCT00404547

[ 4 ]

604

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

null

The aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis.

null

Osteoporosis

osteoporosis bisphosphonate biomarker zoledronic acid alendronate postmenopausal

null

2

arm 1: Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily. arm 2: Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Zoledronic acid was supplied as a concentrate of 5.33 mg zoledronic acid monohydrate in a 100 ml solution. 5.33 mg zoledronic acid monohydrate equals 5 mg zoledronic acid. intervention 2: Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. intervention 3: Combined elemental calcium / vitamin D chewable tablets. Participants took 2 tablets a day, for a daily dose of calcium 1200 mg/vitamin D 800 IU.

intervention 1: Zoledronic acid 5 mg solution intervention 2: Alendronate 70 mg tablets intervention 3: Calcium/Vitamin D

1

Multiple Cities | N/A | Germany | N/A | N/A

0

NCT00404820

[ 3 ]

10

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This phase II trial is studying how well tandutinib works in treating patients who have undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving tandutinib after surgery may kill any tumor cells that remain after surgery.

PRIMARY OBJECTIVES: I. To determine the overall efficacy of MLN518 in patients with metastatic clear cell renal carcinoma. SECONDARY OBJECTIVES: I. To evaluate the effect of MLN518 on progression-free survival and overall survival in patients with metastatic clear cell renal carcinoma. II. To evaluate the toxicity of MLN518 in patients with metastatic clear cell renal carcinoma. III. To evaluate the effects of MLN518 on serum VEGF-A, VEGF-R2, PIGF, and PDGF levels of patients with metastatic renal cell carcinoma receiving MLN518. IV. To determine the VHL gene status, methylation, and pVHL in archived material from the primary nephrectomy specimen of patients receiving MLN518. V. To evaluate tumor blood flow and vessel permeability based on functional imaging with dynamic contrast enhanced magnetic resonance imaging (dceMRI) in metastatic renal cell carcinoma patients treated with MLN518. OUTLINE: This is an open-label, nonrandomized study. Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 4 weeks.

Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer

null

1

arm 1: Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

[ 0 ]

2

[ 0, 10 ]

intervention 1: Given orally, 500 mg bid daily intervention 2: Correlative studies

intervention 1: tandutinib intervention 2: laboratory biomarker analysis

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00408902

[ 0 ]

15

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.

The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavir/ritonavir (LPV/r) to one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will include insulin sensitivity determined by clamp testing, and lipid metabolism and hepatic glucose production assessed using stable isotope techniques. We hypothesize that switching protease inhibitor (PI) to ATV/r from LPV/r will result in direct increases in glucose uptake in muscle and visceral adipose tissue in association with improvements in overall whole body insulin sensitivity compared to remaining on LPV/r. We will complete a prospective randomized trial of Human Immunodeficiency Virus (HIV) infected patients who have been on a stable antiretroviral (ARV) regimen containing LPV/r for at least 6 months and who will be randomized to either switch to a regimen containing ATV/r or remain on LPV/r for 6 months. Each subject will complete Positron Emission Tomography (PET) 18-fluorodeoxyglucose (FDG) imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization.

HIV Infections

HIV Kaletra Reyataz Insulin sensitivity Lipids Body Composition Receiving Kaletra Treatment Experienced

null

2

arm 1: Boosted Reyataz (300mg atazanavir + 100mg ritonavir) arm 2: Kaletra (pre-study dose)

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: atazanavir 300mg + ritonavir 100mg once daily intervention 2: patient remains on their pre-study dose of lopinavir/ritonavir

intervention 1: atazanavir/ritonavir intervention 2: lopinavir/ritonavir

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00413153

[ 0 ]

21

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

false

The purpose of the study is to determine whether treatment of children and adolescents with Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance.

Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. This condition tends to progress to Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth. The investigators found that obese children and adolescents with IGT are characterized by marked insulin resistance related to altered lipid partitioning, favoring lipid deposition in the visceral and intramyocellular compartment. Furthermore, the investigators found an impairment of the acute insulin response in these youngsters. Follow-up revealed a rapid deterioration from IGT to frank diabetes. Based on these studies, there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity. The primary objective of this study is to determine, in a group of ethnically diverse children and adolescents with IGT, whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance. Secondary objectives are to determine whether rosiglitazone is safe and well tolerated.

Obesity Impaired Glucose Tolerance Type 2 Diabetes Mellitus

Childhood and Adolescent Obesity Metabolic phenotype Impaired Glucose Tolerance Type 2 Diabetes Mellitus Insulin Sensitivity Insulin Resistance Abdominal fat partitioning Impaired Glucose Tolerance (IGT) Type 2 Diabetes Mellitus (T2DM)

null

2

arm 1: Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months. arm 2: Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 2mg to begin then 4mg, twice daily for 4 months intervention 2: Subject receives placebo.

intervention 1: Rosiglitazone intervention 2: Placebo

1

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

0

NCT00413335

[ 0 ]

40

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

To investigate the efficacy and safety of once daily enoxaparin as a "bridge" to warfarin for the outpatient treatment of acute deep venous thrombosis or pulmonary embolism.

Background and Significance: Low molecular weight heparin (LMWH) as a "bridge" to warfarin has become the standard of care for outpatient treatment of acute deep venous thrombosis (DVT). LMWH is also often prescribed as a "bridge" to warfarin for patients with acute pulmonary embolism (PE). In the United States, the FDA has approved enoxaparin only for twice daily dosing in outpatient treatment of acute DVT. The FDA has also approved enoxaparin for treatment of DVT with or without PE, but the FDA has not approved enoxaparin for the treatment of PE without DVT. The FDA has also not approved once daily enoxaparin for any DVT or PE treatment indication for outpatients. Once daily dosing of enoxaparin in outpatients with DVT alone, DVT with PE, or PE without DVT will halve the number of required injections, facilitate outpatient treatment, and reduce health care costs. For example, visiting nurses will make one visit daily instead of two visits daily for those patients who are unable self-inject and for those patients who lack family or friends to inject LMWH. Merli et al randomized 900 hospitalized venous thromboembolism (VTE) patients with acute DVT or PE to one of three treatment groups: 1) continuous infusion of unfractionated heparin (UFH), 2) once daily enoxaparin 1.5mg/kg, or 3) twice daily enoxaparin 1mg/kg. All study patients were inpatients. None were outpatients. They received once or twice daily enoxaparin or UFH for at least five days and were "bridged" to warfarin. Patients were followed for three months. Primary endpoints were recurrent DVT or PE. There were no significant differences in recurrent DVT or PE among the 3 treatment groups. There were 12 recurrent VTE events in the UFH group, 13 in the once daily enoxaparin group, and 9 in the twice daily enoxaparin group. The frequency of major hemorrhage did not differ among the three treatment groups. Major hemorrhage occurred in 6 of 290 patients (2.1%) in the UFH group, 5 of 298 patients (1.7%) in the once daily enoxaparin group, and 4 of 312 patients (1.3%) in the twice daily enoxaparin group. Merli et al showed that once daily enoxaparin was as effective and safe as twice daily enoxaparin. But this study was done only among hospitalized patients with acute DVT or PE. Treatment results in hospitalized patients do not necessarily apply to the outpatient population. Therefore, the FDA has not approved outpatient DVT or PE treatment with once daily enoxaparin. The BWH Venous Thromboembolism Research Group has an outstanding track record for investigator initiated trials. We have recently completed 2 investigator initiated trials with enoxaparin for the treatment of PE. One trial was published in Thrombosis and Haemostasis and the other is accepted for publication in Vascular Medicine. Clinically stable PE patients with normal right ventricular size and function as assessed by echocardiogram or chest CT scan are at very low risk of adverse clinical events. Either imaging test is excellent for acquiring the information we need to document normal RV size and function. These clinically stable PE patients with negative biomarkers (troponin) and normal right ventricular function can be safely treated as outpatients. Therefore, we wish to include in this trial clinically stable patients with acute PE who have normal right ventricular size on chest CT in addition to patients with acute DVT. Chest CT with a 4 chamber view with RVD/LVD measurement will be performed in all cases by a radiologist with experience in this technique to confirm normal RV size on all PE patients. In this investigator initiated trial, we will conduct a feasibility study with once daily enoxaparin as a "bridge" to warfarin for outpatient treatment of acute DVT or PE. Subject selection: Physicians caring for DVT and PE patients in the noninvasive vascular lab, Emergency Department, primary care office, and inpatient care units at Brigham and Women's Hospital often summon our Group for consultation. Our Group will under these circumstances describe this protocol. If the referring physician and the patient agrees, these patients will be approached for enrollment by physician investigators from the research team. We will study 40 patients with symptomatic DVT or PE confirmed by ultrasound or chest computed tomography respectively and treat them with once daily enoxaparin as a bridge to warfarin. In this case-control series, we will match 2 historical controls by age and gender to every case. Controls who received twice daily enoxaparin as a "bridge" to warfarin for acute venous thromboembolism will be matched from a retrospective study of previously hospitalized patients. Additional characteristics of matched control group will include: prior DVT or PE, cancer, heart disease, and pulmonary disease. All patients enrolled in the study will receive enoxaparin 1.5mg/kg/day as a bridge to warfarin, using at least 4 outpatient doses of enoxaparin and overlapping enoxaparin and warfarin for at least 4 days. Study Procedures: Enrollment: Eligible patients with confirmed DVT and/or PE who are stable for outpatient treatment will be approached for enrollment. Following enrollment, patients will be started on enoxaparin 1.5mg/kg/day as a bridge to warfarin. Patients will receive overlapping once daily enoxaparin and warfarin for at least 4 days. After enrollment, patients will be started on warfarin 7.5 mg daily. Initial INR will be checked on day 3 after starting warfarin. Thereafter, INR will be checked daily from day 4 to day 7 and until INR is ≥ 2.0 for 2 consecutive days. Enoxaparin will be discontinued after a minimum of 4 days and after 2 consecutive values ≥ 2.0. Once enoxaparin is discontinued patients will continue oral warfarin alone. All INR tests can be done at any hospital, including Brigham and Women's, or at a lab that is closer to patient's home. Study investigators will perform anticoagulation management after discharge for 30 days; with an initial office follow-up visit between days 7 and 13 and a final office visit between days 27 and 33. This will include clinical assessment, and blood testing of renal function and international normalized ratio (INR). Each study visit will take up to 1 hour. Each blood test will require 5 ml of patient's blood. At the conclusion of the 30-day trial, responsibility for anticoagulation, including the decision about its duration, will revert to the Primary Care Physician. Biostatistical Analysis: The sample size of 40 patients serves to assess the feasibility and safety of once daily enoxaparin therapy as a bridge to warfarin for outpatient treatment of acute DVT and/or PE. A composite endpoint of death, recurrent venous thromboembolism, and major hemorrhage will be assessed at 30 days. Comparisons are made on an intention-to-treat basis. Separate analyses will also be performed on each individual endpoint. The statistical analysis plan will include specific exploratory subgroup analyses: DVT without PE, PE without DVT, and combined DVT plus PE. The statistical analysis will be by "intention to treat." In other words, once a patient is recruited, that patient will be analyzed regardless of protocol violations and regardless of missing data. No patient will be excluded from the analyses because of protocol violations, missing data, or any other reason. Chi-squared testing will be used for statistical analysis. For cells with 5 or fewer patients, the Fisher's Exact Test will be used. Efficacy and safety will be statistically evaluated in a composite endpoint. This composite endpoint will include: Death, recurrent venous thromboembolism, and major hemorrhage at 30 days. Separate analyses will also be performed on each individual endpoint.

Deep Vein Thrombosis Pulmonary Embolism

Lovenox Enoxaparin Prophylaxis Pulmonary Embolism Acute Deep Vein Thrombosis Venous Thrombosis Thrombosis Anticoagulation

null

1

arm 1: None

[ 5 ]

1

[ 0 ]

intervention 1: Patient takes 1.5 mg per kilogram, once daily, subcutaneous injections until INR is therapeutic, then medication is stopped.

intervention 1: Enoxaparin

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00413374

[ 4 ]

1,030

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).

The primary objective of this randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows the study medication) , phase III, placebo and active controlled trial is to evaluate the efficacy and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain from osteoarthritis (OA) of the knee. The study is being conducted for registration and approval of tapentadol (CG5503) in the US and outside the US. The trial will consist of five periods: screening (to assess eligibility) , washout (3-7 days with determination of a baseline pain intensity), titration (of dose over 3 weeks to the optimal individual level) , maintenance (investigational drug intake for 12 weeks with adjustments allowed), and follow-up (2 weeks post treatment discontinuation). The study hypothesis is that the study drug will be more effective than placebo in reducing patients pain intensity. The Secondary objectives include the collection of pharmacokinetic (related to how the body uses the drug) information for dose verification. The trial objectives will be assessed by comparing the baseline pain level to the level of week 12 of the maintenance phase. This will be done by looking at the patient's pain diary information. Titrate tapentadol (CG5503) ER (extended release) 50mg to patient's optimal dose ranging between 100mg and 250mg twice a day; Oxycodone CR (controlled release) 10mg to 50mg twice a day; Placebo (no active ingredients). All doses of trial treatment will be taken orally with approximately 120 mL of water with or without food for a maximum timeframe of 15 weeks.

Osteoarthritis, Knee Pain

Chronic Pain Osteoarthritis, Knee tapentadol Pain Assessment

null

3

arm 1: tapentadol (CG5503) 50 100 150 200 250mg twice a day (BID) during 15 weeks arm 2: oxycodone 10 20 30 40 50mg twice a day (BID) during 15 weeks arm 3: placebo matching placebo twice a day (BID) during 15 weeks

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks intervention 2: matching placebo twice a day (BID) during 15 weeks intervention 3: 50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks

intervention 1: oxycodone intervention 2: placebo intervention 3: tapentadol (CG5503)

0

null

0

NCT00421928

[ 5 ]

173

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non ST elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty or bypass surgery)

The study was prematurely discontinued on November 30, 2008 due to delay in meeting pre-defined protocol recruitment milestones. There were no safety concerns regarding the study in the decision to terminate the trial.

Angina, Unstable Myocardial Infarction

Non-ST Elevation Acute Coronary Syndromes coronary interventions

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours. intervention 2: Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg \[units per kilogram\] and initial infusion of 12 U/kg/h \[units per kilogram per hour\]).

intervention 1: Dalteparin ( Fragmin) intervention 2: Unfractionated heparin

8

0

NCT00435487

[ 5 ]

68

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Effect of nicotine patch as an adjutant for acute pain after surgery.

This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/ 15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes.

Pain

acute pain nicotine nausea sedation

null

4

arm 1: Smokers who were treated with nicotine arm 2: Nonsmokers who were treated with nicotine arm 3: Smokers who were treated with placebo arm 4: Nonsmokers who were treated with placebo

[ 0, 0, 2, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: nicotine patch (0,5,10 or 15mg/day) applied to smokers intervention 2: nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers intervention 3: placebo patch applied to smokers intervention 4: placebo patch applied to nonsmokers

intervention 1: nicotine patch intervention 2: nicotine patch intervention 3: placebo intervention 4: placebo

1

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

0

NCT00440830

[ 4 ]

307

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.

null

Osteoarthritis Postoperative Pain

opioid

null

3

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

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 150 milligram (mg)/ day (double blind) intervention 2: 300 mg/day (double blind) intervention 3: Placebo

intervention 1: pregabalin intervention 2: pregabalin intervention 3: Placebo

27

0

NCT00442546

[ 5 ]

77

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of the study is to determine if reducing or eliminating a dopamine agonist (DA) causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet, hallucinations or impulsive behaviors while adding orally disintegrating selegiline can eliminate the adverse effect and maintain control of Parkinson's disease (PD) symptoms.

Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Levodopa is the most effective symptomatic treatment; however, long term use is associated with motor fluctuations (periods of return of PD symptoms when medication effect wears off) and dyskinesia (drug induced involuntary movements including chorea and dystonia). Once patients develop motor fluctuations treatment options include increasing the frequency of levodopa dosing, switching to sustained-release levodopa, adding other therapies including monoamine oxidase type B (MAO-B) inhibitors, dopamine agonists, catechol-o-methyltransferase (COMT) inhibitors and in patients with severe motor fluctuations deep brain stimulation surgery. There are no good evidence based studies indicating whether the use of one of these class of drugs is superior to the other nor are there treatment algorithms that recommend which class of drug should be initiated when the patients initially develop motor fluctuations. It is believed that the efficacy of the different drug classes is similar. However, the frequency of adverse effects may differ between drug classes, but such studies are lacking. In clinical practice when patients develop adverse effects to a drug from one class, a drug from another class is substituted in an attempt to maintain efficacy with reduced adverse effects. Dopamine agonists often have a higher risk of adverse effects compared to MAO B inhibitors. Therefore, the rationale for this study is that the addition of orally disintegrating selegiline after the reduction or discontinuation of the offending dopamine agonist will result in comparable efficacy with reduced adverse events. This study will assess the safety and efficacy of the addition of orally disintegrating selegiline in PD patients who are having adverse effects to dopamine agonists for which a dose reduction of the dopamine agonist is being considered. All patients in the study will receive orally disintegrating selegiline 1.25 mg once a day and the dose will be increased to 2.5 mg once a day if tolerated. Comparisons: The status of the adverse event at the end of the study while on orally disintegrating selegiline will be compared to the adverse event at the start of the study. In addition, efficacy will be compared at the start of the study while on the dopamine agonist to the end of the study with orally disintegrating selegiline.

Parkinson's Disease

Parkinson's disease Dopamine agonist adverse effects MAO-B inhibitor orally disintegrating selegiline Zelapar

null

1

arm 1: This is a one arm open label study of patients who are experiencing a dopamine agonist (DA) related adverse effects (AE) of either one or more of the following: excessive daytime sleepiness, hallucinations, pedal edema, impulse control disorder. All subjects received orally disintegrating selegiline.

[ 5 ]

1

[ 0 ]

intervention 1: 1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated

intervention 1: orally disintegrating selegiline (Zelapar)

17

0

NCT00443872

[ 3 ]

14

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment and at 6 and 12 months on combined therapy as well as the rates of transplant will be compared and evaluated using descriptive analysis.

BACKGROUND: Patients who have been exposed to human tissue by prior transplants, blood transfusion or pregnancy may develop and maintain anti-bodies against these foreign human cells (SENSITIZATION). As a result of sensitization these patients are more likely to reject an organ donated from an individual who possesses a similar human cell marker (ANTIGENIC)profile. These sensitized patients will remain on the kidney transplant waiting list up to twice as long as those who are not pre-sensitized. The Panel of Reactive Antibodies (PRA) is a test panel used to measure the patient reactivity to human leukocyte cell antigens (HLA). A PRA of 75% means the patient reacted to 75% of the antigens on the panel. A high PRA indicates that the subject already has antibodies and is highly SENSITIZED. Spontaneous decreases in PRA titers rarely occur. Thus the probability of transplantation in sensitized patients is significantly decreased. RATIONALE for use of Rituximab: By reducing specific B-cell populations Rituximab is currently used as a treatment in auto-immune diseases such as lupus erythematosus and rheumatoid arthritis and some cancers such as B-cell non-Hodgkin's lymphoma. It has been reported to have a potential roll in decreasing anti-human lymphocyte (HLA) antibodies post transplant. More studies are needed to assess its possible benefit among pre-transplant patients. Vierira et al. \["Rituxan for reduction of anti-HLA antibodies in patients awaiting renal transplantation", Am J Transplantation 2002;2:A870\] reported on the use of rituximab in sensitized patients. Nine patients on dialysis with a PRA \> 50% were treated with rituximab (n=3 per group) at 50, 150, or 375mg/m2. No significant change was seen in WBC, hemoglobin, platelet count, chemistry, liver enzymes or CMV IgG titers. At three days and 6 months after infusion there was a decline in the B cell count compared to pre-infusion levels. In 44%, a decline in PRA was seen. The patients receiving the higher doses had a larger decrement in antibody titers. GENENTECH, INC. will provide Rituximab, labeled for investigational use. Rituximab is formulated for IV administration as a sterile product as a sterile, preservative-free liquid concentrate for intravenous (IV) administration. STUDY DESIGN: This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment and at 6 and 12 months on combined therapy as well as the rates of transplant will be compared and evaluated using descriptive analysis. Primary Endpoints: The number of subjects who experience a decrement from baseline in their Panel of Reactive Antibody values (PRA I, PRA II) or cPRA (calculated PRA when available) at: baseline, 6 and 12 months of study initiation. Secondary Endpoints: The number of subjects who received a transplant The number of subjects with a negative crossmatch if transplanted. STUDY POPULATION: Patients on the kidney transplant waiting list who are currently receiving hemodialysis and who have a Panel of Reactive Antibodies (PRA) titer levels over 50% after completing 8 months of mycophenolate mofetil (MMF) treatment alone. SCREENING: Subjects will be consented, then screened clinically for occurrence of infection, Tuberculosis exposure and for protective antibodies in response to prior vaccination. RITUXIMAB DOSAGE AND ADMINISTRATION: The Rituximab dose is 1000mg (1gm) given as a single I.V. infusion for 2 doses (days 1 and 15). No extra dosing will be given. Rituximab may be administered in an outpatient setting. Hypersensitivity reactions may occur. Premedication, consisting of acetaminophen (1gm) and diphenhydramine (50mg or equivalent dose) by mouth 30 to 60 minutes prior to the start of an infusion will be considered before each infusion of Rituximab. Rituximab will not be re-administered after initial dose regimen. (MMF) Mycophenolate mofetil DOSAGE AND ADMINISTRATION: Dosing of MMF will continue at the highest tolerated dose the subject was taking at the completion of the parent study: "Highly Sensitized Patients: effects of mycophenolate mofetil (MMF) on anti- human lymphocyte antibody (HLA) levels in patients awaiting renal transplant". The dose will be adjusted according to standard practices, gastrointestinal tolerance and WBC count. CLINICAL AND LABORATORY SAFETY EVALUATIONS: SCREENING: * Medical history and documentation of the rationale for treatment of the patient's disease with Rituximab. * Pregnancy test (serum or urine) for women of childbearing potential must be done prior to initial Rituximab treatment date. * Medical history to include: age, sex, prior transplant history, blood transfusion history, prior pregnancy history, history of autoimmune disease, infection history over the last 5 years, and immunization history. * Physical examination, including vital signs, and performance status. * Hematology (within 2 weeks of treatment): complete blood count (CBC) with differential and platelet count. * Serum Chemistries: glucose, blood urea nitrogen, serum creatinine, uric acid, total bilirubin, alkaline phosphatase, low density lipoprotein, high density lipoprotein, total protein, albumin, aspartate aminotransferase(AST), alanine aminotransferase (ALT), and serum calcium. * Serology Testing as appropriate: Hepatitis B, Hepatitis C, HIV * IgG and IgM total antibody counts. * Drug Monitoring: Baseline = pre-infusion. Serum drug levels for Ritux will also be measured for safety. Human Anti-Rituximab Antibody (HACA)is a test for presence of antibodies against rituximab. * Lymphocyte Sub Group: A sub-group of type-B lymphocytes called 'CD-19 Cells' are specifically impacted by Rituximab and will be used as a marker of drug efficacy. ON GOING EVALUATIONS Post -Treatment: For safety the total IgG and IgM levels will be monitored and IgG supplemented if levels decrease below normal values. Additionally WBC counts that drop below 3.0 will result in changes in the MMF dose. If serious infections occur MMF will be discontinued. Patients will be followed for one year after initial rituximab infusion. * Hematology: monitor CBC + differential weekly for 1 month then monthly * Monthly: PRAs will be monitored monthly through the 12th month of the study. The standard PRA value is the sum of anti-bodies produced by 2 main groups of lymphocytes; Class I and Class II. We will have PRA I and PRA II antibody classes reported separately as well as PRA reporting using a calculation (cPRA). * Quarterly: Serology Testing as appropriate: Hepatitis B, Hepatitis C, HIV, IgG and IgM total antibody counts. * Monitor Serum Ritux and HACA levels at baseline, 6 months and 9 months. * Monitor CD19+ B-cells at baseline, weeks 1, 2, 4, months 3, 6, 9 and 12.

Kidney Failure, Chronic Diabetic Nephropathies Glomerulonephritis, IGA Hypertension, Renal

Dialysis Kidney Renal Nephropathy Glomerulonephropathy Immunosuppression Graft Compatibility Transplant Diabetes Hypertension Transplantation, Kidney

null

0

null

2

[ 0, 0 ]

intervention 1: Rituximab dose is 1,000 mg given as an IV infusion every two weeks for 2 doses (days 1 and 15). intervention 2: Cellcept is continued from prior study, taken 500 - 1,000 mg BID, P.O.

intervention 1: Rituximab intervention 2: Mycophenolate mofetil (MMF)

0

null

0

NCT00446251

[ 3 ]

45

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This is a 12-month, phase II, prospective, open label study, to evaluate the effect of mycophenolate mofetil (MMF) among patients on the kidney transplant list with high Panel of Reactive Antibody (PRA) levels. On average, increasing the PRA from 0 to 50% specifically in the Washington Organ Procurement Organization (OPO) increases the waiting time from 3 to 6 years. Spontaneous decreases in the PRA rarely occur and is associated with a decreased chance for transplantation and a decreased rate of survival.

HYPOTHESIS: mycophenolate mofetil given over 8 months to highly sensitized subjects awaiting kidney transplant, will result in a decrement in the PRA by 10% or more in approximately 40% of patients. This decrement should allow an improved rate of transplantation. BACKGROUND: Patients who have been exposed to human tissue by prior transplants, blood transfusion or pregnancy may develop anti-bodies against the 'cell markers of human white blood cells' called 'Human Leukocyte Antigens' (HLA). Preformed anti-bodies to these foreign human tissues is called SENSITIZATION. Sensitized patients are more likely to reject a kidney from a donor who possesses the antigenic profile to which they are already sensitized. This limits the recipient's possible donor pool out of the general population. The Panel of Reactive Antibodies (PRA) is a test panel that represents the HLA antigenic profile of the local community. The test panel is used to measure the recipient's reactivity (by percent) to a variety of HLA antigens. A PRA of 75% means the patient reacted to 75% of the antigens on the test panel. A PRA panel greater than 50% indicates that the subject (potential organ recipient) already has a significant number of antibodies pre-formed to other human tissue and is highly sensitized. Spontaneous decreases in PRA titers rarely occur thus the probability of transplantation in sensitized patients is significantly decreased. STUDY POPULATION: adult University of Washington Medical Center patients, on the kidney transplant waiting list who are currently receiving dialysis with a PRA level over 50% and for a period of 6 months or longer. TREATMENT PLAN/ INTERVENTION: CONSENT: Consent will be obtained from all subjects. SCREENING: Prior to starting MMF, a thorough medical history physical exam will be obtained. Patients will be screened clinically for occurrence of infection and for protective antibodies in response to prior vaccinations and assure that they are up to date with their immunizations. INVESTIGATIONAL PRODUCT: Mycophenolate mofetil (MMF) is used as a routine therapy for the prevention of rejection in transplant recipients and is also used routinely for the treatment of autoimmune disease and primary renal diseases such as IgA nephropathy and lupus nephritis. HOFFMANN LA ROCHE: Will provide Mycophenolate mofetil, MMF as CellCept well as costs for laboratory testing. DOSAGE AND ADMINISTRATION: MMF will be dispensed by investigational drug pharmacists in 250mg capsules, taken orally twice daily. Dosing of MMF will begin at 500 mg bid for 30 days then increased to 1 gm bid if subject is not experiencing undo gastrointestinal side effects or a decrease in WBC. STUDY DESIGN: The subjects will be continually evaluated for 12 months. Month 4: If the subject's PRA drops by 10% at month 4, subject will remain on MMF without any changes. If subject's PRA does NOT drop by 10% at month four and infections have NOT occurred, subject will remain on MMF and increase dosage if possible. If at month four, more than 4 serious infections have occurred the MMF dose will be reduced and or stopped for that subject. If stopped they will be followed for 4 months. Month 8: If the subject's PRA does NOT drop by 10% at month 8, the MMF will be discontinued and the subject will be followed for the next 4 months to month 12 post enrollment. If subject's PRA DOES drop by 10% at month 8 and NO infection(s) have occurred, subject will continue on MMF to month 12. Study subjects will be followed for a maximum of 12 months. OBJECTIVES: The primary endpoint: 1\) The number of subjects who achieve a PRA reduction of 10% or greater within 8 months of initiating mycophenolate mofetil (MMF)therapy. The secondary outcome measures will include: 1. The number of subjects who received a transplant during the study, 2. The number of subjects who experienced Institutional Review Board (IRB) reportable infections, 3. The number of subjects who's white blood cell count (WBC) or Immunoglobulin G or M (IgG/ IgM) titers are below range, 4. The number of transplants with a negative crossmatch. CLINICAL AND LABORATORY EVALUATIONS: LAB ASSESSMENT: Immunology: PRA (panel of reactive antibodies) will be taken monthly and the levels of individual HLA anti-bodies will be evaluated every other month. Safety: Total levels of Immunoglobulin G (IgG) and Immunoglobulin M (IgM), as measures of the indigenous anti-body population levels. As well as HepB surface Antibody and CMV are tests done to monitor to screen for changes in the health of the subject's immune system ie. loss of memory for immunization. A complete blood count (CBC) is taken at each visit to screen for anemia. Differential analysis on CBD for screening against platelet reduction and possible bone marrow suppression. The subject's CBC will be checked more frequently if his/her WBC, hematocrit or platelets are low. Subjects will be followed closely through 12 months.

Kidney Failure, Chronic Diabetic Nephropathies Glomerulonephritis, IGA Hypertension, Renal

CellCept Dialysis Kidney Renal Nephropathy Glomerulonephropathy Immunosuppression Allograft Compatibility HLA PRA Transplant Sensitization Antibodies Diabetes Hypertension Transplantation, Kidney

null

0

null

1

[ 0 ]

intervention 1: 500mg - 1,000mg, taken PO, twice daily.

intervention 1: mycophenolate mofetil (CellCept)

1

Seattle | Washington | United States | -122.33207 | 47.60621

0

NCT00446459

[ 4 ]

59

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.

Clinical experience with Somatuline Autogel to date has raised the possibility of self or partner injection. Previous microparticle somatostatin analogue formulations required careful reconstitution and as a result the cost of the analogues and the inconvenience of reconstitution meant self or partner injection was not a viable option. Somatuline Autogel does not require reconstitution as it comes ready-mixed in a pre-filled syringe, thus making it more user-friendly than its predecessor and introducing the possibility of self or partner injection. Patients with acromegaly often travel considerable distances every 28 days in order to receive their somatostatin analogue injections in the clinic. If Somatuline Autogel can be safely administered unsupervised, while maintaining disease control, this could offer patients considerable benefits in terms of reduced frequency of visits to the clinic. This study is designed to allow suitably motivated patients with acromegaly or their partners to learn how to successfully inject Somatuline Autogel while maintaining their mean GH level control. Disease control in these patients will be assessed by comparing their GH and IGF-1 levels to accepted medical standards for control of acromegaly and by comparing the levels of GH and IGF-1 control achieved with baseline values.

Acromegaly

Acromegaly Somatostatin Analogs Somatuline® Autogel® lanreotide growth hormone IGF-1 Inappropriate Growth Hormone Secretion Syndrome Somatotropin Hypersecretion Syndrome Inappropriate GH Secretion Syndrome

null

1

arm 1: Somatuline Autogel (lanreotide acetate) Injection

[ 0 ]

2

[ 0, 5 ]

intervention 1: Injections intervention 2: Questionnaire

intervention 1: Somatuline Autogel (lanreotide acetate) intervention 2: Home administration

13

0

NCT00447499

[ 5 ]

50

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

true

0ALL

false

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. Observations will be made to monitor physiology.

Myopia Hyperopia

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: lens care system intervention 2: lens care system

intervention 1: Optifree RepleniSH Multipurpose Disinfecting Solution intervention 2: ReNu Multiplus Multipurpose Solution

1

Waterloo | Ontario | Canada | -80.51639 | 43.4668

0

NCT00455455

[ 4 ]

793

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.

The combination of group lifestyle modification counseling and pharmacotherapy has recently been shown to result in nearly twice the average weight loss at one year (12.1 kg) as pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7 kg). Combining pharmacotherapy with a comprehensive program of diet, exercise and group lifestyle modification counseling may provide the best weight loss regimen. This study evaluated weight loss in subjects participating in such a comprehensive program who received a combination of naltrexone SR and bupropion SR, or placebo.

Obesity Overweight

Obesity Behavior Modification

null

2

arm 1: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group lifestyle modification counseling arm 2: Placebo with intensive group lifestyle modification counseling

[ 0, 2 ]

3

[ 0, 0, 5 ]

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

intervention 1: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day intervention 2: Placebo intervention 3: Intensive group lifestyle modification counseling

9

0

NCT00456521

[ 3 ]

35

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This phase II trial is studying the side effects and how well pazopanib works in treating patients with recurrent glioblastoma. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor

PRIMARY OBJECTIVES: I. Determine the therapeutic efficacy of pazopanib hydrochloride, as measured by 6-month progression-free survival (PFS), in patients with recurrent glioblastoma. II. Determine the safety profile of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the efficacy of this drug, as measured by radiographic response, time to progression, and overall survival, in these patients. OUTLINE: This is a multicenter study. Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for at least 2 years.

Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor

null

1

arm 1: Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Other: laboratory biomarker analysis

[ 0 ]

2

[ 0, 10 ]

intervention 1: Given orally intervention 2: Correlative studies

intervention 1: pazopanib hydrochloride intervention 2: laboratory biomarker analysis

9

0

NCT00459381

[ 4 ]

109

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score.

Post-Stroke Spasticity Cerebrovascular Accident

Spasticity Post-Stroke botulinum toxin type A Upper Limb

null

4

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

[ 1, 2, 1, 1 ]

2

[ 0, 0 ]

intervention 1: botulinum toxin type A intervention 2: Placebo

intervention 1: GSK1358820 intervention 2: Placebo

18

Fukuoka | N/A | Japan | 130.41667 | 33.6 Hiroshima | N/A | Japan | 132.45 | 34.4 Hiroshima | N/A | Japan | 132.45 | 34.4 Hokkaido | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Ibaraki | N/A | Japan | 135.56828 | 34.81641 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Shizuoka | N/A | Japan | 138.38333 | 34.98333 Shizuoka | N/A | Japan | 138.38333 | 34.98333 Shizuoka | N/A | Japan | 138.38333 | 34.98333 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Yamaguchi | N/A | Japan | 131.46667 | 34.18333

0

NCT00460564

[ 4 ]

120

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth Scale (MAS) ankle score.

Post-Stroke Spasticity Cerebrovascular Accident

Post-Stroke Lower Limb botulinum toxin type A Spasticity

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: botulinum toxin type A intervention 2: Placebo

intervention 1: GSK1358820 intervention 2: Placebo

20

Fukuoka | N/A | Japan | 130.41667 | 33.6 Hiroshima | N/A | Japan | 132.45 | 34.4 Hiroshima | N/A | Japan | 132.45 | 34.4 Hokkaido | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Ibaraki | N/A | Japan | 135.56828 | 34.81641 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Shizuoka | N/A | Japan | 138.38333 | 34.98333 Shizuoka | N/A | Japan | 138.38333 | 34.98333 Shizuoka | N/A | Japan | 138.38333 | 34.98333 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Yamaguchi | N/A | Japan | 131.46667 | 34.18333

0

NCT00460655

[ 0 ]

16

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

1FEMALE

true

The purpose of this study is to compare two combinations of drugs (mifepristone and misoprostol versus placebo and misoprostol) used for medical treatment for early pregnancy failure. We will compare the two combinations of medications to see which combination makes miscarriage happen faster. We hypothesize that there will be no difference in time to complete miscarriage between the two groups.

The optimal method of treating Early Pregnancy Failure (EPF) is not certain. For many years, surgical management of EPF was the only treatment option. Now there are multiple studies demonstrating the effectiveness of misoprostol for treating EPF. Most of the studies investigating medical treatment of EPF have evaluated efficacy at one week. We have found that many women do not want to wait for one week for an outcome of their medical treatment, and want resolution sooner. This has hampered the widespread utilization of medical therapy in our institution. We propose a regimen of medical treatment for EPF with expeditious follow-up. We want to demonstrate the relative efficacy of two medication regimens for treatment of EPF by performing a randomized trial. One regimen will be 800μg buccal misoprostol alone and the other regimen will be 200mg mifepristone, orally, in addition to 800μg buccal misoprostol, simultaneously. The primary outcome will be complete abortion rates 24hours after medication administration. We hypothesize that mifepristone will not improve complete abortion rates at 24hrs. Secondary outcomes include rates of abortion by medical treatment at one week, the indications for surgical intervention, relationship of progesterone levels and type of pregnancy failure to outcomes in the two groups. Another secondary objective is to assess satisfaction with the treatment process at the conclusion of pregnancy termination, and 3 weeks after the beginning of the process. The majority of studies investigating medical treatment of EPF use vaginal misoprostol, but buccal use is increasing. We will use buccal misoprostol, which is widely used at our institution. We will assess the efficacy of this route of administration as well as assess patient acceptability of this method.

Early Pregnancy Failure Miscarriage Fetal Demise Anembryonic Pregnancy

early pregnancy failure mifepristone misoprostol buccal miscarriage fetal demise anembryonic progesterone

null

2

arm 1: Women in this arm receive placebo and misoprostol 800 mcg buccally arm 2: Womwn in this group receive mifepristone 200 mg orally and misoprostol 800 mcg buccally

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Women in this group receive 800 mcg misoprostol plus a placebo intervention 2: This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally

intervention 1: Misoprostol and placebo intervention 2: Mifepristone and misoprostol

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00468299

[ 2, 3 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

Primary Objectives: 1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma 2. To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma 3. To determine the effects of bortezomib on melphalan pharmacokinetics

Melphalan is designed to damage the DNA of cells, which may cause cancer cells to die. High-dose melphalan is considered the standard of care for multiple myeloma. Bortezomib is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die. Arsenic trioxide may cause cancer cells to die, and researchers want to find out if arsenic trioxide helps melphalan in killing cancer cells. Vitamin C makes arsenic trioxide more available inside the cancer cells, and researchers want to learn if Vitamin C makes arsenic trioxide more effective. Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Your complete medical history will be recorded. You will have a dental exam to check for any infected teeth or gums that may flare up after chemotherapy. You will have a bone marrow aspirate and biopsy. To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. Cytogenetic tests will be performed on the aspirate sample to look for any genetic abnormalities in your DNA. You will have x-rays of your bones taken. The study doctor will look at the x-rays to see if there are any myeloma-related bone changes. You will also have a chest x-ray. You will have blood (about 2 tablespoons) and urine collected for routine tests. You will have a pulmonary function test, to check if your lungs are strong enough for high-dose chemotherapy. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will also have a MUGA scan to evaluate the function of your heart. Women who are able to have children must have a negative blood pregnancy test. The blood will be drawn as part of the 2 tablespoons drawn at screening. If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of dice) to one of 3 treatment groups. There is an equal chance of being assigned to any of the 3 groups. All 3 groups will receive melphalan, arsenic trioxide, and Vitamin C. The second and third groups will also receive bortezomib, but at different dose levels. The first 3 participants assigned to receive bortezomib on this study will receive the lower of 2 bortezomib dose levels. You will receive arsenic trioxide through a needle in a vein over 2 hours, once a day for 7 days (Days -9 to -3). At the same time, you will receive Vitamin C once a day through the vein for 7 days. After you receive the arsenic trioxide on Days -4 and -3, you will receive melphalan through the vein over 30 minutes. If you are in Group 2 or 3, you will receive bortezomib by an intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). You will receive standard inpatient and outpatient stem cell transplant care and testing. You will have to sign a separate consent form that describes the transplant procedure and its risks. Your stem cells will be reinfused 2 days after the last dose of melphalan. To check for any side effects, you will have an ECG performed 14 days after the transplant. If intolerable side effects from the chemotherapy occur or there is sign of disease after the transplant, you will be taken off study. If you have already received melphalan and side effects occur, then the transplant will happen. However, if intolerable side effects develop before melphalan, then you may be taken off study without having the transplant. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant physician decides it is necessary. If there is no sign of disease after the transplant, you will have routine follow-up visits. Blood (about 2 tablespoons) will be drawn for routine tests at least once a week during the first month after the transplant, and then once every month for the next 3 months after that. At about 3, 6, and 12 months after the transplant, you will have bone marrow biopsies and aspirates performed to check the status of the disease. You will have blood (about 2 tablespoons) and urine collected for routine tests. At 12 months after the transplant, you will have x-rays of your bones taken. One (1) year after the transplant, your participation in this study will be over. This is an investigational study. Bortezomib, arsenic trioxide, and melphalan are commercially available and FDA-approved for use in patients with myeloma. However, their use in combination with Vitamin C (also commercially available) is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Myeloma

Multiple Myeloma Melphalan Trisenox Arsenic Trioxide Ascorbic Acid Vitamin C Velcade Bortezomib

null

3

arm 1: Arm 1: Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily arm 2: Arm 2: Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily arm 3: Arm 3: Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

[ 1, 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3). intervention 2: Arm 1 (Level 1): 1.0 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). Arm 2 (Level 2): 1.5 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). intervention 3: 100 mg/m2 by vein days -4,-3, over 30 minutes intervention 4: 1000 mg once a day through the vein for 7 days.

intervention 1: Trisenox (Arsenic Trioxide) intervention 2: Velcade (Bortezomib) intervention 3: Melphalan intervention 4: Vitamin C (Ascorbic Acid)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00469209

[ 3, 4 ]

183

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

false

The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay). The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.

null

Thyroidectomy

Surgery Thyroid gland cervical block Pain, Postoperative

null

4

arm 1: bilateral superficial cervical block, placed before surgery (just before skin incision) arm 2: placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision) arm 3: bilateral superficial cervical block, placed after surgery (just after skin closure) arm 4: placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)

[ 0, 2, 0, 2 ]

2

[ 0, 0 ]

intervention 1: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side. intervention 2: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.

intervention 1: bilateral superficial cervical block intervention 2: placebo bilateral superficial cervical block

1

Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391

0

NCT00472446

[ 3 ]

257

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.

null

Bipolar I Depression

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day \[2 tablets\]) was allowed. The dosage could not be increased after it was decreased. intervention 2: Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.

intervention 1: Armodafinil intervention 2: Placebo

55

0

NCT00481195

[ 4 ]

443

NA

SINGLE_GROUP

4SUPPORTIVE_CARE

0NONE

false

0ALL

false

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Inflammatory Bowel Disease Ulcerative Colitis

IBD UC Ulcerative Colitis Inflammatory Bowel Disease

null

1

arm 1: None

[ 5 ]

1

[ 0 ]

intervention 1: None

intervention 1: Balsalazide Disodium

95

0

NCT00486031

[ 3 ]

78

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)

null

Rheumatoid Arthritis

ACR20, ACR50, ACZ885 (anti-interleukin-1beta monoclonal antibody), rheumatoid arthritis, methotrexate

null

2

arm 1: Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. MTX was given as variable dosing regimen of 7.5 mg-15 mg weekly. arm 2: Methotrexate (MTX) was given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered. intervention 2: Matching placebo was supplied in form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered. intervention 3: Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.

intervention 1: Canakinumab (investigational) intervention 2: Placebo intervention 3: Methotrexate (MTX)

22

0

NCT00487825

[ 0 ]

28

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

4QUADRUPLE

false

0ALL

false

The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome.

The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome. The study is a double blind, placebo controlled, crossover study with the order of treatment randomized. Patients will receive each treatment for 8 weeks with a 1 week rest period between treatment periods. Endothelial function will be tested using non-invasive techniques before and after each treatments. A total of 40 subjects with diabetes or the metabolic syndrome will be enrolled at Boston Medical Center.

Diabetes Mellitus Metabolic Syndrome

endothelium obesity diabetes mellitus dyslipidemia

null

2

arm 1: Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second arm 2: Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: 140 mg/day for 8 weeks intervention 2: 20 mg/day for 8 weeks

intervention 1: Fenofibrate intervention 2: Atorvastatin

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00491400

[ 3 ]

218

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral administration of four dosing regimens of posaconazole relative to placebo and terbinafine, in the treatment of toenail onychomycosis.

null

Onychomycosis

null

6

arm 1: Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. arm 2: Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. arm 3: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. arm 4: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. arm 5: Terbinafine 250 mg QD for 12 weeks. arm 6: Placebo for 24 weeks.

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

6

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

intervention 1: Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. intervention 2: Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. intervention 3: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. intervention 4: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. intervention 5: Terbinafine 250 mg QD for 12 weeks. intervention 6: Placebo for 24 weeks.

intervention 1: SCH 56592 intervention 2: SCH 56592 intervention 3: SCH 56592 intervention 4: SCH 56592 intervention 5: Terbinafine intervention 6: Placebo

0

null

0

NCT00491764

[ 5 ]

12

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.

Hypothesis: Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis. This will result in shorter time to maximal drug concentration, greater maximal concentration, and greater total area under the curve of the concentration vs. time plot. Primary Objective: To compare the pharmacokinetics of omeprazole between immediate-release suspension and delayed-release capsules in patients with heartburn associated with gastroparesis. Study design: randomized, open-labeled, crossover treatment for 7 days with 10-14 days washout. Pharmacokinetic studies will be performed after 7 days on study drug.

Gastroparesis Gastroesophageal Reflux Disease

Gastroparesis Gastroesophageal reflux disease heartburn

null

2

arm 1: subjects receive immediate release omeprazole for 7 days then delayed release for 7 days arm 2: subjects receive delayed release omeprazole for 7 days then immediate release for 7 days

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Immediate-release omeprazole 40 mg qam for 7 days intervention 2: Delayed-release omeprazole 40 mg qam for 7 days

intervention 1: Immediate-release omeprazole intervention 2: Delayed-release omeprazole

1

Louisville | Kentucky | United States | -85.75941 | 38.25424

0

NCT00492622

[ 4 ]

119

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is caused by cigarette smoking or by breathing in other lung irritants, including pollution, dust, or chemicals. The purpose of this study is to evaluate the effectiveness of zileuton, a medication that is used to control asthma symptoms, at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation, or worsening of COPD symptoms.

COPD is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. COPD is the fourth leading cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. Treatment usually includes inhaled bronchodilator or steroid medications that work by relaxing the muscles around the lung airways and reducing inflammation. Zileuton, a medication that is used to prevent asthma symptoms, may be beneficial in treating people who experience COPD exacerbations. Zileuton works by blocking the formation of substances that cause inflammation, fluid retention, and constriction in the lungs. The purpose of this study is to evaluate the effectiveness of zileuton at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation. This study will enroll adults who are admitted to the hospital due to severe COPD symptoms. Participants will be randomly assigned to receive either zileuton or placebo four times a day for up to 14 days. While in the hospital, lung function testing and urine collection will occur. Study visits will occur at Days 14 and 30, and will include lung function testing, a medical history review, and a study drug adverse effects review.

Pulmonary Disease, Chronic Obstructive

Chronic Obstructive Pulmonary Disease COPD Exacerbation Anti-leukotriene Length of Stay LOS

null

2

arm 1: Zileuton (Zyflo, 600 mg 4 times a day) arm 2: Placebo

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Zyflo tablets, 600 mg, 4 times a day intervention 2: Placebo 4 x daily

intervention 1: Zileuton intervention 2: Placebo

18

0

NCT00493974

[ 5 ]

17

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Chronic fatigue syndrome is a disabling illness for which there is no specific treatment. As a group, CFS patients have disturbed sleep with frequent arousals and the sense of not having slept upon awakening. Xyrem (Sodium oxybate) is known to improve deep sleep and so may reduce the sleep disturbances of CFS leading to better sleep with less fatigue. Its ability to produce the rapid onset of deep sleep is a reason it became a street drug, but its availability is currently limited via distribution through a single centralized pharmacy. Xyrem has been successfully used based on results from a study on patients with fibromyalgia (FM), an ailment closely resembling CFS. However, in that study, the researchers provided no information as to whether patients had FM alone or FM plus CFS. Thus, it is not clear from this study just which patient may be helped. I have prescribed Xyrem for patients who have both FM and CFS with good results. In this study, funded by the company that makes Xyrem, I propose testing the drug's efficacy on patients with CFS alone - that is, they do not have fibromyalgia. Volunteers for this study will complete paper and pencil questionnaires about their symptoms as well as a computerized test to assess their degree of brain fog. They will then be randomly assigned to one of two groups, placebo or drug. Volunteers will not know what group they are in until the end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks identical to the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will be told to skip taking the second dose. We will call patients weekly to see how they are doing on the "drug." If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect of treatment, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.

Medically unexplained fatigue occurs in about 5% of the population with 10% of that number fulfilling formal case definitions for chronic fatigue syndrome1. Medically unexplained fatigue is a major problem for both patient and practitioner - for both because there is no effective FDA-approved treatment for the symptom. One major problem for these patients is unrefreshing sleep. Formal sleep studies show reduced total sleep time and reduced sleep efficiency compared to controls.2;3 We are currently in the early stages of an NIH-funded grant designed to study cytokines during sleep. Preliminary results support awake time for patients relative to controls, producing a decreased sleep efficiency. These data lead to our working hypothesis that the problem of severe daytime fatigue is due to a previously unappreciated form of sleep pathology related to sleep fragmentation. Patients with medically unexplained pain also complain of disturbed sleep. Sodium oxybate has been tested on patients with this complaint who fulfill a formal case definition for fibromyalgia and has found to reduce symptoms and improve sleep quality.4 Specifically, six of 7 pain/fatigue scores (overall pain, pain at rest, pain during movement, end of day fatigue, overall fatigue, and morning fatigue) were relieved by 29% to 33% with sodium oxybate, compared with 6% to 10% relief with placebo (p \< 0.005). Alpha intrusion indicative of disturbed sleep, sleep latency, and rapid-eye-movement sleep were significantly decreased, while slow-wave (stage 3/4) sleep was significantly increased, compared with placebo (p \< 0.005). Two of the 5 subjective sleep related variables were significantly different from placebo: morning alertness (improved by 18% with sodium oxybate, compared with 2% for placebo; p = 0.0033) and quality of sleep (improved by 33% and 10%, respectively; p = 0.0003). Importantly, approximately 40% of patients in my study group fulfill case definitions simultaneously for CFS and FM. Since we do not know if patients in either sodium oxybate treatment trial had CFS, we cannot be sure whether efficacy was specific for FM or instead may have occurred due to the fact that a large representation of CFS had occurred. An unpublished Phase II randomized double-blind placebo controlled trial in FM, done by Jon Russell and colleagues in Dallas and presented at the 2005 meeting of the American College of Rheumatology, reported substantial symptom improvement with statistically significant benefits in self reported pain scales and patient global impression of improvement at both doses of sodium oxybate tested compared with placebo \[4.5g \[9ml\] total dose per night; p=0.005 and 6g \[12 ml\], p=0.048\]. Improvement in outcome variables was 34.5% at the 4.5g and 27.3% at the 6g compared to 12.5% in the placebo group. I have prescribed sodium oxybate in my own practice for patients who have both CFS and FM with good results. Anecdotally, patients reporting less pain also reported better quality sleep and less fatigue upon awakening. This has led me to hypothesize that sodium oxybate will reduce fatigue in patients with CFS alone (i.e., without also having FM). To test this hypothesis, I propose doing a double blind, placebo controlled trial of sodium oxybate in 30 patients who fulfill a formal case definition for chronic fatigue syndrome and who do not also have FM.

Chronic Fatigue Syndrome

chronic fatigue pain sleep xyrem must have chronic fatigue syndrome no hypertension no sleep apnea

null

2

arm 1: Patients were randomized and these received placebo arm 2: Patients were randomized and these received the active drug

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached. intervention 2: Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predetermined maximum is reached.

intervention 1: Placebo intervention 2: Sodium Oxybate

1

Newark | New Jersey | United States | -74.17237 | 40.73566

0

NCT00498485

[ 4 ]

246

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate \>=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

null

Rheumatoid Arthritis

null

1

arm 1: Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.

[ 0 ]

2

[ 0, 0 ]

intervention 1: \>=15 mg po/week intervention 2: 1g iv on days 1 and 15

intervention 1: Methotrexate intervention 2: rituximab [MabThera/Rituxan]

49

Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Córdoba | N/A | Argentina | -64.18853 | -31.40648 San Miguel de Tucumán | N/A | Argentina | -65.21051 | -26.81601 Belém | N/A | Brazil | -48.50444 | -1.45583 Brasília | N/A | Brazil | -47.92972 | -15.77972 Brasília | N/A | Brazil | -47.92972 | -15.77972 Campinas | N/A | Brazil | -47.06083 | -22.90556 Campinas | N/A | Brazil | -47.06083 | -22.90556 Curitiba | N/A | Brazil | -49.27306 | -25.42778 Florianópolis | N/A | Brazil | -48.54917 | -27.59667 Fortaleza | N/A | Brazil | -38.54306 | -3.71722 Fortaleza | N/A | Brazil | -38.54306 | -3.71722 Goiânia | N/A | Brazil | -49.25389 | -16.67861 Nova Lima | N/A | Brazil | -43.84667 | -19.98556 Porto Alegre | N/A | Brazil | -51.23019 | -30.03283 Recife | N/A | Brazil | -34.88111 | -8.05389 Ribeirão Preto | N/A | Brazil | -47.81028 | -21.1775 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 Salvador | N/A | Brazil | -38.49096 | -12.97563 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Vitória | N/A | Brazil | -40.33778 | -20.31944 Santiago | N/A | Chile | -70.64827 | -33.45694 Barranquilla | N/A | Colombia | -74.78132 | 10.96854 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Cuenca | N/A | Ecuador | -78.9963 | -2.8953 Guayaquil | N/A | Ecuador | -79.88621 | -2.19616 Quito | N/A | Ecuador | -78.52495 | -0.22985 San Salvador | N/A | El Salvador | -89.18718 | 13.68935 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Mexico City | N/A | Mexico | -99.12766 | 19.42847 San Luis Potosí City | N/A | Mexico | -100.97135 | 22.15234 Jesus Maria | N/A | Peru | -77.04495 | -12.06982 Lima | N/A | Peru | -77.02824 | -12.04318 San Isidro | N/A | Peru | -77.04258 | -12.09655 Montevideo | N/A | Uruguay | -56.18816 | -34.90328 Barquisimeto | N/A | Venezuela | -69.35703 | 10.0647 Caracas | N/A | Venezuela | -66.87919 | 10.48801 Caracas | N/A | Venezuela | -66.87919 | 10.48801

0

NCT00502996

[ 4 ]

186

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.

Idiopathic Parkinson's Disease

Rotigotine Neupro®

null

1

arm 1: Rotigotine

[ 0 ]

1

[ 0 ]

intervention 1: Rotigotine transdermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: The maximum rotigotine dose allowed is 16 mg/24 hours.

intervention 1: Rotigotine

26

0

NCT00505687

[ 5 ]

86

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.

Novo Nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial.

Diabetes Diabetes Mellitus, Type 2

null

2

arm 1: Individually adjusted dose of insulin detemir once daily arm 2: Individually adjusted dose of insulin NPH once daily

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Treat-to-target, s.c. (under the skin) injection, once daily intervention 2: Treat-to-target, s.c. (under the skin) injection, once daily

intervention 1: insulin detemir intervention 2: insulin NPH

2

Paris La Défense | N/A | France | N/A | N/A Cambridge | N/A | United Kingdom | 0.11667 | 52.2

0

NCT00506662

[ 5 ]

158

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study is looking at three seizure medicines. Patients with seizures are usually treated with phenytoin (Dilantin) or Fosphenytoin. These medicines can be given intravenously (IV)or by mouth. Another seizure medicine, levetiracetam (Keppra) can now be given this way also. This study will compare IV phenytoin (Dilantin) and IV fosphenytoin to levetiracetam (Keppra) in patients who have had a recent seizure. Only patients with a history of seizures can be involved. The patient must present to the emergency department within 4 hours of a seizure. The purpose of this study is to compare these three drugs, phenytoin (Dilantin), fosphenytoin, and levetiracetam (Keppra). The investigators are looking to see if these drugs can prevent another seizure in the next 24 hours. We are also looking for any possible side effects.

More than one in every one hundred patients presenting to the emergency department for care do so for seizures. More than half of these patients will require medications, often intravenously (IV), while in the emergency department. For many years the standard treatment has been phenytoin. However, there are many known contraindications to the use of this drug. These include known hypersensitivity, cardiac arrhythmias, cardiac disease, impaired liver or kidney function, diabetes mellitus, older age, thyroid disease, pregnancy, and alcohol use. A recent review of patients with seizure disorder at Emory Crawford Long and Emory University hospitals suggested that a significant percentage of those who were taking phenytoin actually had one or more of these contraindications. Additionally, the IV form of phenytoin has known, severe adverse effects including cardiovascular collapse, life threatening cardiac arrhythmias, and severe hypotension. There is another form of Phenytoin, called Fosphenytoin, that while safer in some respects still has similar concerns associated with its administration. Levetiracetam (Keppra) has been available as an oral drug in the United States since 2000 and has a well established safety record when used as an add-on drug for patients with partial onset seizures. A double-blinded randomized study has shown that levetiracetam is also effective for primary generalized seizures as well. The IV form of levetiracetam has recently been approved by the FDA for use. The only known contraindications other than known hypersensitivity include impaired renal function, psychiatric disorder, older age, and pregnancy. IV levetiracetam is not known to cause any of the acute, catastrophic events seen occasionally with phenytoin. The investigators would therefore like to compare IV phenytoin and fosphenytoin to IV levetiracetam in preventing early recurrent seizures. Patients with known seizure disorders would be randomly assigned to one of two groups and therefore receive either IV fosphenytoin or IV levetiracetam. After an observation period, seizure free patients would be discharged and 24 hour phone follow up conducted to assess for the effectiveness of these anti-seizure medications as well as for any adverse reactions.

Tonic-clonic Seizure

tonic-clonic seizure emergency department IV levetiracetam Keppra seizures phenytoin Dilantin Grand Mal seizure

null

2

arm 1: Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals). arm 2: Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).

[ 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: The patient will receive 1 gram of Keppra added to 100ml diluent and will be infused over 15 minutes. intervention 2: IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals. intervention 3: IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals.

intervention 1: Keppra intervention 2: Fosphenytoin intervention 3: Dilantin

1

Atlanta | Georgia | United States | -84.38798 | 33.749

0

NCT00510783

[ 5 ]

4

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

false

Objectives: The primary objective of this study is to determine the efficacy of eszopiclone at treating sleep problems related to withdrawal from nicotine in healthy smokers attempting smoking cessation. Sleep disturbances are a significant problem for smokers who are trying to quit smoking. Smokers may be more likely to have sleep problems and both nicotine withdrawal and agents used to aid smoking cessation (e.g., pharmacotherapies) may disrupt sleep. Lunesta (eszopiclone) is a medication that has been approved by the FDA to treat insomnia. Eszopiclone's efficacy for treating insomnia makes it a promising agent for treating nicotine withdrawal-related symptoms of sleep disturbance. This study will be 7 weeks duration. All participants will begin taking Zyban at the beginning of week 1 and will be asked to try to quit smoking at the beginning of week 2. Participants will also begin to take Lunesta or matched placebo (3 mg qd x 6 weeks) on the target quit date at the beginning of week 2. All subjects will receive eight (8) weekly sessions of brief individual supportive smoking cessation counseling. Hypothesis: It is hypothesized that significantly fewer sleep problems will be reported by participants taking Lunesta as compared to placebo. Specifically, it is expected that participants taking Lunesta will report less difficulty falling and staying asleep, higher sleep quality, and less insomnia-related fatigue and distress than participants taking placebo.

null

Insomnia Nicotine Dependence

insomnia nicotine dependence smoking smoking cessation zyban

null

2

arm 1: Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + Lunesta (3 mg qd x 6 weeks) arm 2: Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + placebo (1 pill per day x 6 weeks)

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: eszopiclone (lunesta) - 3 mg qd x 6 weeks, oral capsule intervention 2: bupropion SR in oral capsule will be begun at the beginning of week 1 (150 mg qd x 7 days) with an increase to the full dose (150 mg bid x 6 weeks) at the beginning of week 2.

intervention 1: Eszopiclone intervention 2: Bupropion

1

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

0

NCT00511134

[ 2, 3 ]

20

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to assess the safety and tolerability of imatinib (gleevec) in subjects who have systemic sclerosis. Imatinib has been approved by the FDA for the treatment of newly diagnosed adult patients with CML (newly diagnosed adult patients and for the treatment of patients with an accelerated phase. Imatinib is also approved for the treatment of patients with a certain type of gastrointestinal cancer (called stromal tumors) but it has not been approved to treat systemic sclerosis. Imatinib works by interfering with an enzyme called tyrosine phosphatase resulting in suppression of the immune system. It als interferes with a protein called platelet derived growth factor receptor (PDGFr) that has been linked to increased fibrosis.

Systemic sclerosis is a rare, progressive disease that leads to hardening and tightening of the skin and connective tissues. It usually begins with a few dry patches of skin on the hands or face that begin getting thicker and harder. These patches then spread to other areas of the skin. In some cases, systemic sclerosis also affects the blood vessels an internal organs. Systemic sclerosis is one of a group of arthritic conditions called connective tissue disorders, a person's antibodies are directed against their own tissues.

Alveolitis Systemic Sclerosis

active alveolitis in systemic sclerosis

null

1

arm 1: SSc patients receiving Imatinib (Gleevec, up to 600 mg) QD PO for up to 1 year.

[ 0 ]

2

[ 0, 0 ]

intervention 1: All subjects will receive gleevec. Subjects will have a clinic visit every 2 weeks for the first 20 weeks and then they will have one every 4 weeks for the remainder of the study. Gleevec will be taken by mouth everyday. It will be increased to a maximum of 600 mg every day. It will be increased 100 mg at each visit for the first 12 weeks. Your participation may last up to 1 year and participants will have approximately 18 clinic visits. intervention 2: Up to 600 mg QD PO for up to 1 year.

intervention 1: Imatinib intervention 2: Imatinib

1

Los Angeles | California | United States | -118.24368 | 34.05223

0

NCT00512902

[ 3 ]

510

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123 for the detection of myocardial ischemia. Readers independent of the clinical study centers will review results of imaging studies in a blinded fashion at an imaging core lab. The resulting independent reading of the images will be compared against the truth standard for ACS.

null

Acute Coronary Syndrome

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Iodofiltic acid I 123

38

0

NCT00514501

[ 0 ]

5

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

1FEMALE

false

A. Null Hypothesis: In term pregnancies complicated by diabetes, there is no difference in the time interval from start of induction to delivery when outpatient cervical ripening and labor induction is initiated with orally administered misoprostol, a prostaglandin El analogue, compared to placebo. B. Specific aims: 1. Demonstrate that oral misoprostol is effective for cervical ripening compared to placebo when given in an outpatient basis to women with pregnancies complicated by diabetes mellitus. 2. Demonstrate that oral misoprostol can be administered safely in an outpatient setting. The patients will be observed for a period of four hours in an outpatient antepartum testing unit after the medication is administered to demonstrate fetal well being and verify that there is no evidence of uterine hyperstimulation. (We acknowledge that markers of serious adverse maternal and neonatal outcomes are rare, and can only be adequately addressed in large multicenter trials.) 3. Assess the cost differential in inpatient and outpatient utilization of misoprostol for cervical ripening and labor induction. In order to estimate the impact that outpatient cervical ripening may have on total hospitalization costs, we will use daily hospital charges and published data regarding pharmaceutical costs.

The study proposed is a single center study. Study participants will be recruited from the high risk obstetrical diabetic resident clinic, the Magella Women's Perinatal Group, and Fetal Diagnostics at Miller Children's hospital. The resident clinic is supervised by the faculty from the division of Maternal Fetal Medicine from the department of Obstetrics and Gynecology. Patients with class A1, A2 diabetes mellitus at term who are usually considered for inpatient cervical ripening and labor induction will be approached for participation in the study. Informed consent will be obtained by members of the perinatal research team. One hundred twenty-eight patients will be enrolled to assess treatment efficacy. Sixty four patients will be treated with misoprostol 50mcg PO q day for two days (days 1 and 4) and sixty four patients will receive placebo (vitamin C) q day for two days (days 1 and 4) for cervical ripening and labor induction. Sample size calculations were performed assuming that 50% of untreated patients will deliver within 7 days of entry. Using an estimate that a 50% increase in this number to 75% would be clinically important, and assuming a Type I error of 0.05 and a Type II error of 0.2, we calculated that a sample size of 58 patients in each group was necessary. The test was one-sided. Assuming a 10% loss to follow-up rate, sixty four patients will be needed in each group. A predetermined randomization schedule for the 128 patients has been established and the randomization assignments placed in opaque, sealed envelopes. The randomization was performed using a computer-generated random number table. The pharmacy will prepare and distribute the study medication according to the randomization schedule after eligible participants sign the informed consent. Once a patient is randomized, the pharmacy will be contacted to provide the medications to the research/antepartum testing unit nurse. The proposed study length is two years, or the time needed to enroll 128 total participants. Each individual's total participation time is that needed to complete the protocol. After delivery, the prenatal and hospital charts of each participant will be reviewed and data abstracted. Outpatient Procedures: 1. Initial complete history and physical exam by physicians in the clinics, including cervical exam. 2. The patients will be sent to the antepartum testing unit to undergo a non-stress test and amniotic fluid index measurement as indicators of fetal well-being. 3. Candidates will be approached for study participation and informed consent obtained. 4. The pharmacy will be contacted for randomization and provision of the study medications. 5. A research nurse or physician, trained in labor and delivery, will be responsible for administration of the study medication (50 mcg misoprostol or placebo). 6. The patient will be observed in the antepartum testing unit for a period of 4 hours after receipt of the study medication. 1. Adequate uterine activity will be defined as \>=3 uterine contractions (UC's) in 10 minutes. Inadequate uterine activity will be defined as \<=2/10 minutes. Continued adequate uterine activity will require continued observation on the labor and delivery unit. If there is cessation of uterine activity while under observation on labor and delivery and the fetal heart rate pattern remains reassuring, the patient will be discharged home to return in three to four days for a second dose of medication or oxytocin, as appropriate. 2. Adequate cervical ripening: If, following receipt of the medication, a patient demonstrates a change in cervical score to \>6, she will be admitted for delivery. 3. If spontaneous labor ensues, or the patient demonstrates uterine hyperstimulation, she will be transferred to the labor and delivery unit. 7. If after the period of observation, the fetal heart rate testing remains reassuring and the patient is not in labor or developed an adequate contraction pattern, she will be discharged home. 8. If discharged home, the patient will be instructed to return 3 or 4 days later (coincident with standard antepartum testing protocol) for re-evaluation for a second dose of the study medication. 9. On the second day coincident with antepartum testing, a repeat cervical examination will be performed by a research nurse, resident or attendant physician. Non Stress Test will be performed. If the Bishop score is \>6, the patient will be admitted to labor and delivery for oxytocin augmentation of her labor. If the Bishop score is less than this, the Non Stress Test is reactive, amniotic fluid index normal, and uterine activity is minimal, she will be administered a second dose of 50 mcg of oral misoprostol. Observation in the antepartum testing unit will be for 4 hours. Again, if labor does not ensue and the fetal heart rate remains reassuring, the patient will be sent home again with instructions to return 3-4 days later coincident with standard NST. 10. On the morning of the seventh day (one week after enrollment and receipt of first dose of oral misoprostol, 39 ½ weeks' gestational age), the patient will be admitted to the labor and delivery unit to undergo inpatient cervical ripening with oral misoprostol, or oxytocin induction or augmentation as appropriate. 11. All patients who are discharged home on days 1 and 4 will be instructed to observe for signs of labor or ruptured membranes, and to assess fetal movement while at home. They will be instructed to return to the emergency room if they experience uterine contractions occur as often as every 5 minutes for 1 hour, rupture of membranes, heavy vaginal bleeding or decreased fetal movement. 12. A 24-hour emergency phone number will be provided for all patients enrolled into this study protocol. 13. Labor management during the active phase of labor on the unit will be at discretion of the managing physician. Labor and delivery admission procedure: 1. Intravenous access will be obtained. 2. Standard laboratory studies will be drawn, including Type and screen, complete blood count, capillary blood glucose. 3. Continuous external fetal monitoring and external tocodynamometry will be utilized. 4. A cervical examination will be performed by the physician. NOTE: These (1-4) are the standard procedures applied to patients admitted to labor and delivery. Misoprostol Inpatient Administration: Those patients who remain with an unripened cervix and with uterine contractions less than 12/hour after completion of days 1 and 4 of outpatient treatment will be candidates to receive misoprostol as an inpatient on day 7 per the following protocol. 1. The dosing schedule will be as follows: 100 micrograms of misoprostol given orally every 4 hours to a maximum of 6 doses. (The medication will be provided by the pharmacy). A. The maximum cervical ripening period will be 24 hours. After 24 hours of misoprostol, if the patient has not entered active labor, the induction process may be continued with oxytocin as necessary. B. Continued, regular uterine activity (3 uterine contractions in a 10 minute period) will preclude repeat dosing. 2. In the event of spontaneous rupture of membranes, the patient will receive no further doses of misoprostol. Oxytocin may be utilized to augment labor at the discretion of managing physician. 3. If the patient develops a uterine contraction abnormality as defined below, either terbutaline, 0.25 mg IV or SQ or MgSO4 intravenous infusion may be administered as necessary. If such abnormalities are encountered during oxytocin administration, the infusion will be discontinued and the same treatment may be utilized. 4. The maximum time period for cervical ripening with misoprostol is 24 hours, which may be followed immediately by an adequate trial of oxytocin, which usually will not exceed 24 hours. Thus, no inpatient cervical ripening/induction attempt will exceed 48 hours. Oxytocin Induction/ Augmentation (as necessary): 1\) These patients will receive oxytocin infusions according to the standard labor and delivery protocol at Miller and Children's Hospital. Study Outcomes: The primary outcome measure will be the time interval from start of induction to delivery. Other outcome measures will be number of doses of medication required, oxytocin requirements, and route of delivery. The number of patients admitted to labor and delivery in active labor will also be assessed as will interval changes in Bishop's score after application of medication. Also intrapartum complications including uterine hyperstimulation, fetal distress and excessive bleeding at the time of delivery will be compared, as will adverse maternal and neonatal outcomes, e.g., development of endometritis or admission to the NICU respectively. Expected Outcomes: We anticipate that approximately 20% of patients after receiving misoprostol will enter the active phase of labor and require transfer to labor and delivery. We also anticipate that we will find significant differences in Bishop's scores between the two groups from day 1 and 4, and find significantly shorter time intervals from start of induction to delivery in those patients who receive the active agent.

Diabetes, Gestational

Term Pregnancy Diabetes Cervical Ripening Induction misoprostol Term Gestational Diabetics

null

2

arm 1: patients will be treated with misoprostol 50 mcg PO arm 2: patients will receive placebo (Vitamin C)

[ 1, 2 ]

2

[ 0, 7 ]

intervention 1: patients will be treated with misoprostol 50 mcg PO q day for two days (days 1 and 4) intervention 2: patients will receive placebo (vitamin C) q day for two days (days 1 and 4)

intervention 1: Misoprostol intervention 2: Placebo

1

Long Beach | California | United States | -118.18923 | 33.76696

0

NCT00514618

[ 0 ]

96

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This project aims to a) evaluate the effects of selected antipsychotic medications on insulin action in skeletal muscle (glucose disposal), liver (glucose production) and adipose tissue (whole-body lipolysis), b) evaluate the effects of selected antipsychotic medications on abdominal adipose tissue mass, total body fat and total fat-free mass, and c) explore the longitudinal effects of treatment with selected antipsychotics on glucose tolerance, lipid profiles, abdominal adipose tissue mass, total body fat and total fat-free mass. These hypotheses will be evaluated by measuring 1) whole-body glucose and lipid kinetics with the use of "gold-standard" stable isotope tracer methodology, 2) body composition using dual energy x-ray absorptiometry and magnetic resonance imaging, and 3) longitudinal changes in glucose tolerance and lipid profiles. The aims will be addressed in non-diabetic schizophrenia patients chronically treated with risperidone, olanzapine, clozapine, quetiapine, ziprasidone, or haloperidol, and untreated healthy controls. Re-evaluations will also be performed in patients who are randomized to switch from their current antipsychotic (from the above groups) to risperidone, olanzapine, quetiapine, or ziprasidone for 6 months. Relevant data is critically needed to target basic research, identify long-term cardiovascular consequences, and plan therapeutic interventions.

Hyperglycemia and type 2 diabetes mellitus are more common in schizophrenia than in the general population. Type 2 diabetes mellitus is characterized by disturbances in insulin action on skeletal muscle, liver and adipose tissue. Diabetes causes increased morbidity and mortality due to acute (e.g., diabetic ketoacidosis) and long-term (e.g., cardiovascular disease) complications. The combination of hyperglycemia, dyslipidemia and abdominal adiposity is even more strongly associated with increased cardiovascular morbidity and mortality. The association of type 2 diabetes and hyperglycemia with schizophrenia was first noted prior to the introduction of antipsychotic medications, suggesting that these patients may be at increased risk. Since then, however, additional glucoregulatory abnormalities (e.g., new onset diabetes), dyslipidemia, and increased weight and adiposity have all been associated with antipsychotic medications. Concern about antipsychotic effects on glucose, lipids and adiposity has increased recently, focusing on the widely-used newer medications, clozapine and olanzapine. Increased abdominal adiposity can secondarily decrease insulin sensitivity and antipsychotics can increase adiposity. However, medication effects on glucose control and insulin action may also occur independent of differences in adiposity. This project aims to a) evaluate the effects of selected antipsychotic medications on insulin action in skeletal muscle (glucose disposal), liver (glucose production) and adipose tissue (whole-body lipolysis), b) evaluate the effects of selected antipsychotic medications on abdominal adipose tissue mass, total body fat and total fat-free mass, and c) explore the longitudinal effects of treatment with selected antipsychotics on glucose tolerance, lipid profiles, abdominal adipose tissue mass, total body fat and total fat-free mass. These hypotheses will be evaluated by measuring 1) whole-body glucose and lipid kinetics with the use of "gold-standard" stable isotope tracer methodology, 2) body composition using dual energy x-ray absorptiometry and magnetic resonance imaging, and 3) longitudinal changes in glucose tolerance and lipid profiles. The aims will be addressed in non-diabetic schizophrenia patients chronically treated with risperidone, olanzapine, clozapine, quetiapine, ziprasidone, or haloperidol, and untreated healthy controls. Re-evaluations will also be performed in patients who are randomized to switch from their current antipsychotic (from the above groups) to risperidone, olanzapine, quetiapine, or ziprasidone for 6 months. Relevant data is critically needed to target basic research, identify long-term cardiovascular consequences, and plan therapeutic interventions.

Schizophrenia Schizoaffective Disorder Type 2 Diabetes Mellitus Hyperglycemia

control risperidone olanzapine quetiapine ziprasidone

null

4

arm 1: Participants in this group were randomized to flexibly-dosed treatment with olanzapine. arm 2: Participants in this group were randomized to flexibly-dosed treatment with risperidone. arm 3: Participants in this group were randomized to flexibly-dosed treatment with quetiapine. arm 4: Participants in this group were randomized to flexibly-dosed treatment with ziprasidone.

[ 1, 1, 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: randomized to 12 week trial of risperidone. intervention 2: randomized to 12 week trial of olanzapine. intervention 3: randomized to 12 week trial of quetiapine. intervention 4: randomized to 12 week trial of ziprasidone.

intervention 1: risperidone intervention 2: olanzapine intervention 3: quetiapine intervention 4: ziprasidone

2

0

NCT00515723

[ 2, 3 ]

16

NA

SINGLE_GROUP

9OTHER

0NONE

false

1FEMALE

true

The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.

Adolescents with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor I (IGF-I), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels GH. It is possible that deficiency of IGF-I, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in AN. The physiologic effects of rhIGF-I treatment in adolescents with AN had not been studied. The goal of this proposal was to investigate the acute effects of rhIGF-I on bone metabolism in adolescent girls with AN. Specific Aim: It was hypothesized that adolescent AN patients, being IGF-I deficient, would respond to exogenously administered rhIGF-I with elevations in biochemical indices of bone turnover. Therefore, rhIGF-I was administered to AN patients by subcutaneous injection over 10 days with concomitant measurement of indices of bone turnover, and calcium regulatory hormones.

Anorexia Nervosa

Adolescents Anorexia nervosa (AN) Bone formation markers Insulin like growth factor-1 (IGF-I)

null

1

arm 1: Adolescent girls with AN meeting inclusion criteria were administered recombinant human (rh) rhIGF-1 at a dose of 35-40 mcg/k twice daily by subcutaneous injections for a 7-10 day period.

[ 0 ]

1

[ 0 ]

intervention 1: 35-40 mcg/k/dose twice daily SC

intervention 1: RhIGF-1

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00516386

[ 4 ]

30

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

false

The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.

The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings

Myopia

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: contact lens care system intervention 2: contact lens care system

intervention 1: ClearCare intervention 2: Optifree Replenish

1

Waterloo | Ontario | Canada | -80.51639 | 43.4668

0

NCT00520351

[ 2, 3 ]

10

RANDOMIZED

CROSSOVER

9OTHER

3TRIPLE

true

1FEMALE

false

The purpose of this research study is to see if giving women a hormone called "ghrelin" will increase levels of growth hormone in the blood and increase appetite. Ghrelin is a naturally occurring hormone that is produced mostly by the stomach and causes secretion of another hormone called growth hormone. It also increases short-term appetite and may lower the amount of inflammation in the body. Some people lose their appetite as they age and have unintentional weight loss. This may be caused by a break in the communication between the stomach and the brain. We are particularly interested in seeing if there is a difference in the effects of ghrelin in older women who have lost weight recently without wanting to and those who have not.

Five community-dwelling women aged 70 or over with unintentional weight loss of \>5% in the prior year plus at least 2 of the 4 remaining Fried criteria for frailty and five healthy women without any frailty criteria were enrolled. Women with conditions that can cause weight loss or taking an appetite stimulant or corticosteroids were excluded. Each woman completed two 180 minute infusions, one week apart, assigned randomly: a graded ghrelin infusion of 2.5, 5.0, and 10.0 pmol/kg/min for 60 minutes each and an equivalent placebo (saline) infusion. A meal of standardized composition was provided after each infusion and intake quantified. Samples were collected every 30 minutes for growth hormone (GH), and total and active ghrelin. Additional samples were collected every 60 minutes for glucose, insulin, free fatty acids, leptin, adiponectin, resistin, glucagon-like peptide-1 receptor agonists (GLP-1), and cortisol. Adverse events were collected during the infusion and by telephone 24 hours later. Non-parametric methods were used to compare differences in response to the ghrelin and placebo infusions 1) in all women and 2) between frail and healthy women.

Frailty

frailty ghrelin appetite weight loss

null

4

arm 1: Healthy and Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion. arm 2: Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion. arm 3: Healthy Women 70 and Older are administered a 3 hour graded Ghrelin Infusion (the first hour of the ghrelin infusion a dose of 2.5 pmol/kg/min, increased to a dose of 5.0 pmol/kg/min for one hour, and then increased to the dose of 10 pmol/kg/min for the final hour of the infusion). arm 4: Frail Women 70 and Older are administered a 3 hour graded Ghrelin Infusion (the first hour of the ghrelin infusion at a dose of 2.5 pmol/kg/min, increased to a dose of 5.0 pmol/kg/min for one hour, and then increased to the dose of 10 pmol/kg/min for the final hour of the infusion).

[ 2, 2, 1, 1 ]

4

[ 0, 0, 10, 10 ]

intervention 1: At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped. intervention 2: At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min will be infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped. intervention 3: At time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped. intervention 4: At time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped.

intervention 1: Ghrelin Infusion - Healthy intervention 2: Ghrelin Infusion - Frail intervention 3: Placebo Infusion -Healthy intervention 4: Placebo Infusion - Frail

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00520884

[ 4 ]

460

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).

null

Constipation

Opioid-Induced Constipation

null

3

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

[ 2, 0, 0 ]

2

[ 0, 10 ]

intervention 1: Subcutaneous intervention 2: placebo

intervention 1: N-methylnaltrexone bromide (MOA-728) intervention 2: placebo

78

0

NCT00529087

[ 4 ]

602

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.

null

Adult Periodontitis

null

3

arm 1: sham treatment arm 2: Placebo arm 3: Minocycline HCL 2.1%

[ 3, 2, 1 ]

2

[ 0, 3 ]

intervention 1: Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months. intervention 2: scaling and root planing

intervention 1: minocycline HCl 2.1% intervention 2: Scaling and root planing

10

0

NCT00529555

[ 4 ]

1

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

Primary Objectives: 1. To assess the ratio in sensitivities of OraTest® in combination with visual examination versus visual examination alone in the detection of serious pathology defined as severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors. 2. To estimate the adjusted specificity of OraTest® in combination with visual examination in the detection of severe dysplasia, CIS, or cancer of the O/OP cavity. Secondary Objectives: 1. To assess the ratio of sensitivity of OraTest® in combination with visual examination versus visual examination alone in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in situ, or severe dysplasia of the oral/oropharyngeal (O/OP) cavity due to their age and lifestyle risk factors. 2. To obtain the adjusted specificity of OraTest® in combination with visual examination in the detection of certain chromosomal abnormalities (17p chromosomal deletions, or both 3p and 9p chromosomal deletions), severe dysplasia, CIS or cancer of the O/OP cavity. 3. To evaluate the chromosomal status of the positively staining lesions with respect to 3p, 9p, or 17p deletions. 4. To carry out gene expression studies on biopsies and map these onto an analysis of the widespread chromosomal imbalances in stain-positive and stain-negative lesions. 5. To evaluate the quantitative and qualitative toxicities, as well as other safety parameters, of tolonium chloride 5 mg/mL (OraTest®).

OraTest® is a blue dye that is designed to stain cancer cells differently than normal cells. SCHEDULED EVALUATION (FIRST VISIT): Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your medical history will be recorded. Women who are able to have children must have a negative urine pregnancy test. Your heart rate, breathing, temperature, and blood pressure will be measured before as well as after the first visit. Visual Exam - If you are found to be eligible to take part in this study, you will have a visual examination where a doctor (Examiner #1) will look inside your mouth very carefully to look for any abnormal lesions and check the glands in your neck. This is called the visual exam. Rinse Staining Procedure (OraTest®) - A second doctor (Examiner #2) will perform another oral exam, followed by the new test using OraTest®. This new test uses a blue dye which may stain any potential cancer blue so it may make it easier for the doctor to detect any abnormal lesions in your mouth. You will be asked not to have intensely-colored sweets like lollipops or drinks like black currant juice within 24 hours of your scheduled visit. First you will rinse your mouth with about 6 teaspoons of vinegar solution for about 20 seconds and spit it out. Next you will rinse your mouth with 6 teaspoons of water for 20 seconds and spit it out. Then you will rinse your mouth with about 2 teaspoons of OraTest® for 20 seconds and spit it out. Then you will rinse your mouth with about 6 teaspoons of vinegar solution for 20 seconds and then spit it out. Then you will rinse your mouth with 6 teaspoons of water for 20 seconds and spit it out. Examiner 2 will then check and see if any abnormal tissue absorbed the dye. If no suspicious lesions are found by either doctor, you will have completed the study. You will be asked to notify the clinic, by phone, if any side effects occur within 7 days after your visit. If you are unable to phone the clinic, you will be given diary cards to record these side effects. The diary cards are to be mailed to the doctor in the pre-stamped envelope given to you. If any suspicious lesions are found by either doctor (or both), then you will be asked to return in about 2 weeks to confirm the result. This is called the Confirmation Exam. CONFIRMATION EXAM (SECOND VISIT): At the visit to confirm the result, you will be examined by the same doctor(s) who found the suspicious lesion(s). The doctor(s) will use the same examination method that was used during the first visit. Your heart rate, breathing, temperature, and blood pressure will be measured before as well as after the second visit. If you have any suspicious lesions, a specialist at M. D. Anderson will biopsy your lesion(s), at this second visit or within 5 days after the visit. During the biopsy, the doctor may use the OraTest® cotton swab to help locate the suspicious spot. If the dye is used at the biopsy visit, your heart rate, breathing, temperature, and blood pressure will be measured before and after the use of OraTest®. After locating the spot, the doctor will perform the biopsy. This means that some tissue lining in your mouth from the suspicious area will be removed. Some of your tissue will be sent to a laboratory for diagnosis. Your doctor will decide the type of care you may need based on the results of the biopsy. The biopsy procedure is standard practice and may happen even if you did not participate in this study. After the biopsy is taken of the lesion, you will have completed the study. If a suspicious lesion is found and you are required to have a biopsy, a sample of tissue from the biopsy will be sent to a laboratory outside of M.D. Anderson for review and diagnosis. Medical research including genetic testing, chromosomal analysis and other tests may be performed on your biopsy. These samples cannot be returned to you because the tissue is destroyed during the genetic tests. Before your tissue is sent to the outside laboratory your name and any personal identifying information will be coded to protect your privacy. M. D. Anderson will not have oversight of any leftover tissue and/or blood that will be banked by BRT Laboratories Inc. for additional research. If no suspicious lesions are seen at this second visit, then you have completed the study. If the dye was used during the exam, then you will be asked to notify the clinic by phone if any side effects occur within 7 days after your visit. If you are unable to phone the clinic, you will be given diary cards to record these side effects. The diary cards are to be mailed to the doctor in the pre-stamped envelope given to you. This is an investigational study. OraTest® has not yet been FDA approved for commercial use. All study procedures and OraTest® will be provided free of charge; the Sponsor will pay for the study drug and pregnancy test if necessary. If further standard of care is needed (for example, due to abnormalities found), you and/or your insurance company will be responsible for the cost. Insurance companies and Medicare may not pay for the costs of some research studies like this one. If your insurance company does not cover the cost of care, then you will have to pay these costs. You have the right to ask what it will cost you to take part in this study or to have other treatments. If you withdraw from the study early, you will only be paid for the portion of the study that you completed. Up to 4000 patients will take part in this multicenter study. Up to 50 will be enrolled at M. D. Anderson.

Head And Neck Cancer Oropharynx Cancer

Head And Neck Oropharynx Oral Cancer OraTest OraTest Dye Rinse Staining Procedure Visual Examination

null

1

arm 1: OraTest dye

[ 5 ]

2

[ 10, 0 ]

intervention 1: Two (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck. intervention 2: Two (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit.

intervention 1: Visual Examination intervention 2: OraTest

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00537199

[ 4 ]

23

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients

null

Chronic Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic

thrombopoietin, immunosuppressive therapy, eltrombopag, idiopathic thrombocytopenic purpura, blood platelet, splenectomy

null

2

arm 1: Subject will initiate treatment with SB-497115-GR 12.5mg once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR may be adjusted at 12.5mg, 25mg or 50mg. arm 2: Subject will initiate treatment with SB-497115-GR 12.5mg matching placebo once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR 12.5mg matching placebo may be increased to 2 tablet of SB-497115-GR 12.5mg matching placebo.

[ 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: SB-497115-GR 12.5mg tablet once a day intervention 2: SB-497115-GR 25mg tablet once a day intervention 3: SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day intervention 4: SB-497115-GR 25mg tablet x2 once a day

intervention 1: SB-497115-GR 12.5mg intervention 2: SB-497115-GR 25mg intervention 3: SB-497115-GR 12.5mg matching placebo intervention 4: SB-497115-GR 50 mg

7

Gifu | N/A | Japan | 136.76039 | 35.42291 Hiroshima | N/A | Japan | 132.45 | 34.4 Ibaraki | N/A | Japan | 135.56828 | 34.81641 Osaka | N/A | Japan | 135.50107 | 34.69379 Osaka | N/A | Japan | 135.50107 | 34.69379 Tochigi | N/A | Japan | 139.73333 | 36.38333 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00540423

[ 2, 3 ]

24

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.

This project involves investigation of oral N-acetylcysteine (NAC) as a potential pharmacologic agent for treatment of cannabis dependence in adolescents. Cannabis dependence continues to be a major problem among adolescents in the United States. To date, psychosocial interventions have produced only small to modest effect sizes in controlled trials, and minimal work has been done to investigate the potential role for pharmacotherapy for cannabis dependence. Translating preclinical research suggesting a role for NAC in cocaine dependent individuals, our research group has developed preliminary evidence of decreased cocaine use and cue reactivity in humans taking NAC. Preclinical research has additionally demonstrated significant parallels in glutamatergic dysfunction in the nucleus accumbens (the proposed target of NAC treatment) between habitual cocaine and marijuana users. NAC is an inexpensive, long-available agent with a favorable tolerability profile in adults and children. However, it has not yet been studied in cannabis dependent adolescents. Hence, we are undertaking an open-label pilot trial of NAC in adolescents with cannabis dependence. The primary specific aims of the proposed project are: 1. To assess the feasibility of conducting a trial of NAC in cannabis dependent adolescents. 2. To assess the safety and tolerability of NAC in cannabis dependent adolescents The secondary specific aim of the proposed project is: 3. To gather variability information to assist in design of a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents. Primary hypotheses 1. It will be feasible to recruit and retain cannabis dependent adolescents in a trial of NAC. 2. NAC will be well tolerated among cannabis dependent adolescents. Secondary hypothesis 3. Adequate variability information will be gathered to design a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents. Twenty-four adolescents between 12 and 20 years old will be recruited in this study. Results from this project will be used to design further studies.

Cannabis Dependence

Cannabis Marijuana Pharmacotherapy Adolescent

null

1

arm 1: All participants will receive N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues will be investigated.

[ 0 ]

1

[ 0 ]

intervention 1: N-Acetylcysteine 1200 mg twice daily for four weeks

intervention 1: N-Acetylcysteine

1

Charleston | South Carolina | United States | -79.93275 | 32.77632

0

NCT00542750

[ 5 ]

56

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.

null

Atopic Dermatitis

null

1

arm 1: Receive between 22 and 29 days of Cutivate lotion treatment

[ 0 ]

1

[ 0 ]

intervention 1: Daily applications

intervention 1: Fluticasone propionate 0.05% lotion

10

0

NCT00546000

[ 3 ]

14

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to determine whether HPN-100 is safe and tolerable in subjects with Urea Cycle Disorders.

When protein is broken down in the body, nitrogen is formed. In healthy individuals, the body combines this nitrogen with other molecules to create a harmless substance called urea, which is excreted in the urine. Patients with Urea Cycle Disorders (UCD) are unable to create as much urea from nitrogen, and therefore, toxic levels of nitrogen can accumulate in the body, causing harm. To treat these patients, doctors usually have the patient consume less protein and supplement certain amino acids that may be lacking. A drug called Buphenyl® is sometimes prescribed as an adjunctive treatment for the chronic maintenance of UCD patients in order to keep ammonia levels down. Some issues with Buphenyl® include a high pill burden (up to 40 pills per day), bad taste and odor, and high sodium content. Like Buphenyl®, HPN-100 provides an alternate way for the body to dispose of nitrogen, other than through the urea cycle. Unlike Buphenyl®, HPN-100 is an odorless, tasteless, concentrated oil that does not contain large amounts of sodium. Study acquired from Horizon in 2024.

Urea Cycle Disorders

Buphenyl Sodium Phenylbutyrate Urea Cycle Disorder UCD

null

1

arm 1: Buphenyl treatment for one week was followed by dose escalation to HPN-100. Dose of Buphenyl was gradually decreased while HPN-100 dose was gradually increased until subject reached dosing of 100% HPN-100. HPN-100 at 100% of the dose was given for 1 week before subject was switched back to original Buphenyl treatment.

[ 1 ]

2

[ 0, 0 ]

intervention 1: Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study. intervention 2: BUPHENYL® (sodium phenylbutyrate) tablets and powder have been approved for marketing in the United States since 1996 as an adjunctive therapy in the long-term management of patients with UCDs involving deficiencies of CPS, OTC, or ASS.

intervention 1: HPN-100 intervention 2: BUPHENYL®

2

0

NCT00551200

[ 3 ]

1

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This is a two-arm, double-blind, placebo-controlled study.

null

Parkinson's Disease

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 2 mg/d for 14 days followed by 4 mg/d for 14 days intervention 2: Matching placebo for for 14 days followed by 4 mg/d for 14 days

intervention 1: perampanel intervention 2: placebo

3

0

NCT00566462

[ 2, 3 ]

18

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in forced expiratory volume in one second (FEV1), or an increase in methemoglobin.

Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A cycle of chronic, persistent infections with CF-related pathogens and an excessive inflammatory response progressively damages the airways and lung parenchyma, resulting in widespread bronchiectasis and ultimately, respiratory failure. Despite tremendous advances in understanding the CF gene and the CFTR protein, it is not known exactly how mutations in the gene and defects in CFTR lead to persistent airway infection and inflammation. Inhaled nitric oxide (NO) has potential to be an effective treatment in CF lung disease. Inhaled NO has been studied in other airways diseases characterized by infection and /or inflammation such as COPD and idiopathic pulmonary fibrosis. NO has been shown to activate CFTR and alternative chloride channels, thereby increasing chloride current in epithelial cells. Therefore, NO treatment may be beneficial in individuals with CF.

Cystic Fibrosis

Inhaled Nitric oxide Cystic Fibrosis

null

3

arm 1: Subjects in the low dose cohort receive 20 part per million (ppm) of nitric oxide via nasal cannula over a 44 hour period. arm 2: Subjects in the high dose cohort receive 40 ppm of nitric oxide via nasal cannula over a 44 hour period. arm 3: 100% Nitrogen (placebo) will be administer at 20 ppm or 40 ppm via nasal cannula over a 44 hour period.

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Nitric oxide will be administered at 20 ppm via nasal cannula over a 44 hour period. intervention 2: Nitric oxide will be administered at 40 ppm via nasal cannula over a 44 hours period. intervention 3: 100% nitrogen (placebo) will be administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period.

intervention 1: Nitric Oxide for Inhalation intervention 2: Nitric Oxide for Inhalation intervention 3: Nitrogen

1

Denver | Colorado | United States | -104.9847 | 39.73915

0

NCT00570349

[ 0 ]

204

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The study is exempt from informed consent by the MetroHealth Medical Center institutional review board (IRB), because two standards of care are used and there is no increased clinical risk to the patient due to the study. The researchers randomize either fentanyl or morphine to be given to trauma patients and record how their pain scale is treated along with observing for adverse events. They are looking to see if the hypothesized benefits of fentanyl (which is much more expensive than morphine) actually exist.

Periodic reports are made to the IRB.

Pain Relief Adverse Events

helicopter aeromedical pain relief analgesia fentanyl morphine adverse events

null

2

arm 1: Morphine given to trauma patients transported by helicopter arm 2: Fentanyl given to trauma patients transported by helicopter

[ 1, 1 ]

1

[ 0 ]

intervention 1: either morphine 4mg IV or fentanyl 50mcg IV

intervention 1: either fentanyl or morphine

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00580489

[ 5 ]

19

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

1FEMALE

true

The purpose is to perform a one-year study designed to assess whether treatment of hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium within bone, decreases bone turnover, and favorably impacts upon skeletal muscle mass, functional status, measures of physical function and quality of life. I hypothesize that treatment of hypovitaminosis D results in improved intestinal calcium absorption, greater retention of calcium within the bone reservoir and improved physical function, quality of life and muscle mass.

Postmenopausal women with vitamin D insufficiency will participate in this one-year study. We will study the change in intestinal calcium absorption from baseline (vitamin D insufficiency) to follow up (vitamin D repletion and whether increased absorption results in subsequent increased retention of calcium within bone over the one-year interval as measured by bone densitometry. We will also study the effect of vitamin D repletion upon whole body muscle mass, quality of life and physical function. A review of medical records and a screening visit will determine eligibility. Eligible and consenting subjects will present to the GCRC in the early morning and following baseline labs, will consume breakfast with a glass of orange juice enriched with a stable calcium isotope, and will receive 3 mg of another stable calcium isotope by intravenous injection. Over the next eight hours, blood will be taken a total of 9 more times and over the first 24 hours, all urine and stool will be collected for measurement of its calcium content. Subsequently for the next five days, women will collect three urine specimens daily. Women will then receive vitamin D to treat vitamin D deficiency. Once vitamin D repletion is accomplished, all women will repeat their 24-hour visit and subsequent five-day urine collections. Women will maintain vitamin D repletion by taking a twice monthly tablet (50,000 IU) of vitamin D2. To confirm vitamin D repletion and safety over the full one year study, additional study visits will occur at 3, 6 and 12 months. A bone density test at screening and twelve months will allow us to assess the effect of vitamin D repletion on whole body bone mass and skeletal mass. At each GCRC stay, 3, 6 and 12 months, women will complete questionnaires regarding quality of life and functional status and will perform the Timed Up and Go Test. Because we wish to maintain and confirm constant calcium intake throughout the one- year study, women will complete a calcium questionnaire at baseline, 3, 6 and 12 months. With each subject's consent, we will collect one tube of blood and isolate its DNA. When sufficient knowledge is available regarding the pathophysiologic mechanisms whereby genetic polymorphisms impact calcium homeostasis, we will test for such DNA polymorphisms and relate genetic information with other data collected on calcium homeostasis.

Osteoporosis Osteopenia Vitamin D Deficiency Hypoparathyroidism Hypercalciuria Hypercalcemia

Calcium Absorption Intestinal Absorption of Calcium Fractional Calcium Absorption Stable Calcium Isotopes Hypovitaminosis D Vitamin D Bone Mineral Density Physical Function

null

1

arm 1: Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).

[ 0 ]

1

[ 0 ]

intervention 1: 50,000 IU po qd for 15 days and 50,000 IU po twice month for 10 months (until final study visit at one year)

intervention 1: Vitamin D

1

Madison | Wisconsin | United States | -89.40123 | 43.07305

0

NCT00581828

[ 5 ]

20

RANDOMIZED

CROSSOVER

9OTHER

2DOUBLE

true

0ALL

true

Automobile driving is a crucial aspect of everyday life, yet vehicular crashes represent a serious public health problem. Patients with epilepsy are at elevated risk for automobile crashes, causing great personal suffering and financial costs to society. Most collisions involving epileptic drivers are not seizure related but may instead result from cognitive effects upon driving performance of epilepsy and antiepileptic drugs (AEDs). Several million American drivers take AEDs for treatment of medical conditions besides epilepsy and may also be at risk for cognitive impairments that can reduce driving performance. Empirical evidence of the effects of AEDs on driving performance would enable development of driving guidelines that could lower the risk of injurious motor vehicle collisions; however, this evidence is currently lacking. The broad goal of our project is to determine the specific effects of the most commonly utilized AED, phenytoin, by assessing driving performance and cognitive abilities in neurologically normal volunteers taking phenytoin in a randomized, double-blind, placebo-controlled, crossover study. Our proposed experiments will assess: (1) cognitive functions using standardized neuropsychological tests (of attention, perception, memory, and executive functions), (2) driving performance during phenytoin and placebo administration, and (3) the effects of phenytoin-related cognitive performance upon driving performance. To measure driving performance, we will use a state-of-the-art fixed-base interactive driving simulator that allows us to observe driver errors in an environment that is challenging yet safe for the driver and tester, under conditions of optimal stimulus and response control. The results of this study of 30 drivers treated with phenytoin and placebo will increase the understanding of the role of AED-related cognitive impairment on driving safety errors. A better understanding of the impact of AEDs upon driving performance is necessary to rationally develop interventions that could help prevent crashes by drivers treated with AEDs.

Patients with epilepsy are at elevated risk for automobile crashes, causing great personal suffering and financial costs to society. Most collisions involving epileptic drivers are not seizure related but may instead result from cognitive effects upon driving performance of epilepsy and antiepileptic drugs (AEDs). Several million American drivers take AEDs for treatment of medical conditions besides epilepsy and may also be at risk for cognitive impairments that can reduce driving performance. Empirical evidence of the effects of AEDs on driving performance would enable development of driving guidelines that could lower the risk of injurious motor vehicle collisions; however, this evidence is currently lacking. The broad goal of the current project is to determine the specific effects of AEDs on cognitive function and driving performance. To address this goal we will assess driving performance and cognitive abilities in neurologically normal volunteers taking phenytoin (Dilantin), the most commonly prescribed AED. Effects of phenytoin on driving performance and cognition will be addressed in a randomized, double-blind, placebo-controlled, crossover study. Driver cognition will be assessed using a battery of neuropsychological tests. Driving performance will be objectively assessed in all participants on standardized tasks enacted in a state-of-the-art driving simulator. Our 3 Specific Aims are: Aim 1: To assess the effects of phenytoin on cognitive abilities that are crucial to the driving task, including perception, attention, memory, and executive function. Hypothesis 1: A driver's cognitive abilities will decline during steady-state phenytoin administration compared to placebo. Drivers with higher blood levels of phenytoin will show greater decline. Aim 2: To assess effects of phenytoin on driving performance and safety errors in a state-of-the-art driving simulator. Hypothesis 2: Driving performance will decline and driver safety errors will increase during phenytoin administration compared to placebo. Drivers with higher blood levels of phenytoin will show greater impairments of driving. Aim 3: To assess the effects of phenytoin-related cognitive impairments upon driving performance in a state-of-the-art driving simulator. Hypothesis 3. Impairments of cognitive function affecting perception, attention, memory, executive function, and arousal will increase the likelihood of driver errors that may lead to a crash. Our hypotheses would be supported if the drivers taking phenytoin, as opposed to placebo, demonstrate worse cognitive performance on neuropsychological tests, and more safety errors and crashes in the simulator. The hypotheses would also be supported if drivers with higher phenytoin levels show greater impairments of cognition and driving. Once the effects of phenytoin on driving performance are demonstrated in this project, we will have evidence to support more comprehensive research addressing specific dosing and serum levels and acute versus chronic administration. There is currently no evidence concerning the effects of phenytoin on driving performance. Accurate driving performance data on patients receiving phenytoin would allow determination of fair and accurate criteria for making recommendations to drive or not to drive affecting millions of patients taking AEDS for epilepsy and other conditions. These data could also help reduce the risk of car crashes due to medication side effects.

Cognitive Measures Driving Simulator Performance

epilepsy cognitive impairment driving simulation cross-over study

null

2

arm 1: Phenytoin administration arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Phenytoin will be dosed to a target dose of 5 mg/kg qhs for one month intervention 2: Placebo

intervention 1: Phenytoin intervention 2: Placebo oral capsule

1

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

0

NCT00581893

[ 0 ]

141

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

This is a double blind, controlled clinical trail testing whether three doses of 1.25 mg of nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone every 20 minutes. The primary hypothesis of this study is that three doses of 1.25 mg of nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone every 20 minutes. The secondary hypothesis is that the treatment combination of levalbuterol and ipratropium will lead to fewer hospitalizations than levalbuterol alone in patients with acute asthma exacerbation. Other secondary objectives include (1) evaluating the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and FEV1, (2) the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and change in FEV1,(3) time to event analysis for an improvement of 15%, 20%, 30%, 40%, and 50% in FEV1 from initial presentation value, (4) analysis of FEV1 at discharge.

Patients will then receive, in a randomized double-blinded fashion, levalbuterol, 1.25mg every 20 minutes for a total of 3 aerosolized doses combined with ipratropium, 0.5mg every 20 minutes for a total of 3 aerosolized doses. The medication will be premixed by the pharmacy in a total of 3 ml of normal saline and the nebulizer will be driven with oxygen at 6 liters per minute. A second plasma sample for analysis of albuterol isomers will be drawn within a fifteen minute window following the third aerosol treatment. Spirometry will be repeated again at 30 and 60 minutes after the third aerosol treatment (Figure 1). All patients will receive prednisone, 60mg orally immediately after their first dose of aerosolized medications, unless contraindications to prednisone administration are present. Patients will not receive any other medications during the time course of the study. Vital signs and pulse oximetry will be repeated prior to each nebulized treatment and again 30 minutes after the third nebulized treatment. The study will terminate 60 minutes after the third aerosol administration. At that point, any further therapy will be at the discretion of the treating physician. Patients will be questioned about the occurrence of any side effects from levalbuterol treatment including palpitations, anxiety, nausea, vomiting or headache. Patients will also be questioned about the occurrence of any side effects from ipratropium, including dry mouth, dry eyes, and urinary retention. Patients will be withdrawn from the study at any point these side effects become intolerable to the patient or any time the patient so desires. Patients will also be withdrawn if they develop palpitations and have an ECG that demonstrates ventricular or supraventricular tachycardia. .Patients will be called 14 days after their ED visit to assess relapse or recurrence of acute asthma exacerbation. In addition, a chart review will be performed to assess relapse or recurrence of acute asthma exacerbation, as well as determine hospital length of stay in those patients who required admission after the initial visit.

Asthma

Asthma Bronchodilators Levalbuterol Ipratropium

null

2

arm 1: levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline) arm 2: ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses

[ 1, 0 ]

1

[ 0 ]

intervention 1: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses

intervention 1: ipratropium

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00583778

[ 3 ]

53

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age with asthma. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Asthma

Asthma Respiratory Tract Diseases

null

2

arm 1: Cross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization. Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization. arm 2: Cross-over phase: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization. Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

[ 5, 5 ]

2

[ 0, 0 ]

intervention 1: Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). intervention 2: Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

intervention 1: arformoterol intervention 2: levalbuterol

14

0

NCT00583947

[ 3 ]

10

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan. Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to troponin C. This agent is approved in Europe for treatment of heart failure patients. In the United States, this agent is currently under phase III investigation for intravenous treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal activity. Levosimendan has been studied in these patients with acute HF and is considered experimental in the United States for this population.

null

Heart Failure

null

1

arm 1: All randomized patients receive drug.

[ 0 ]

1

[ 0 ]

intervention 1: 10-minute infusion

intervention 1: levosimendan

1

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

0

NCT00585104

[ 5 ]

36

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime routines.

null

ADHD Attention Deficit Hyperactivity Disorder

ADHD Attention Deficit Hyperactivity Disorder Daytrana MTS Patch Methylphenidate Transdermal System

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses) intervention 2: Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)

intervention 1: Methylphenidate Transdermal System intervention 2: Placebo

1

Cambridge | Massachusetts | United States | -71.10561 | 42.3751

0

NCT00586157

[ 0 ]

36

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

2DOUBLE

true

0ALL

false

Background. In congenital long QT syndrome type 1 (LQT1), episodes of ventricular tachycardia are usually triggered by exercise and can be prevented in most patients by beta-blocker therapy. In addition, LQT1 associated with a normal resting QT interval can be unmasked by the abnormal QT response to exercise testing (failure of the QT interval to shorten normally). Preliminary data from our laboratory show that the exercise QT intervals of patients with LQT1 are partially normalized by beta-blocker therapy. It is still currently not known if beta-blockers modify the QT/heart rate relationship (a primary effect on repolarization) or if the "normalizing" effect is due to the inability of subjects on beta-blockers to attain sufficiently high workloads (due to reduced heart rate) for prolongation to occur. Moreover, the physiologic response of the exercise QT interval to beta-blockers in healthy control subjects is not known. Objective. The objective of this study is to define the impact of beta-blocker therapy on the QT response to exercise and recovery in normal subjects. Methods. Approximately 36 healthy adult subjects age-matched to previously studied LQT1 subjects will undergo 1) screening history, 2) two weeks of beta-blocker therapy ending in an exercise test, and 3) two weeks of placebo therapy ending in an exercise test. Beta blocker and placebo will be given in random order in a double-blind fashion. The QT response to exercise and recovery will be compared between drug-free and beta-blocker-treated states. These data will be compared to those previously collected for LQT1 subjects. Implications. These results will provide new information about the effect of beta-blocker therapy on repolarization parameters in normal subjects, and will provide a context in which to interpret the previous findings that beta-blocker administration modifies the QT response to exercise in LQT1 subjects.

null

Long QT Syndrome Cardiac Repolarization

QT interval beta-blocker exercise electrocardiogram repolarizaton

null

2

arm 1: Subjects are assigned to placebo. arm 2: Subjects will take propranolol LA 80 mg daily for one week then 160 mg for one week followed by the exercise test.

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Placebo will be given 1 pill daily for a week, then 2 pills daily, followed by the exercise test. intervention 2: Subjects will receive propranolol LA 80 mg one pill daily for 1 week then 2 pills daily for 1 week followed by exercise test.

intervention 1: Placebo intervention 2: Propranolol LA

0

null

0

NCT00588965

[ 2, 3 ]

9

RANDOMIZED

PARALLEL

7BASIC_SCIENCE

4QUADRUPLE

false

0ALL

true

The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).

This protocol is investigating novel pharmaceutical agents (Phenylbutyrate and Genistein), which are aimed at improving the physiologic function of mutant Cystic Fibrosis Transmembrane conductance Regulator (CFTR). CFTR is absent or dysfunctional in cystic fibrosis. Nasal epithelial CFTR function will be assessed by the NPD procedure. We will test the hypotheses that: 1. Phenylbutyrate given orally for 4 days will be safe in adult Delta F508- heterozygous subjects with CF and will result in small improvements in nasal epithelial CFTR function. 2. Topical administration of Genistein to the nasal epithelia of Phenylbutyrate treated Delta F508-heterozygous CF subjects will be safe and lead to augmentation of the improved nasal epithelial CFTR function observed during Phenylbutyrate treatment, but not during placebo treatment. Study Flow If eligibility is confirmed at the screening visit, there will be an additional 3 outpatient visits over a 1-2 week period, lasting 2-4 hours each. Visit 1, all study related safety evaluations will be completed. There will also be a Nasal Potential Difference (NPD) measurement performed. To measure nasal potentials, or voltages, a small butterfly needle will be placed in the skin of the forearm and connected by a thin plastic tube to a monitoring device. A very small soft plastic catheter or tube will be placed against the inner surface of the nose. This catheter will pump a very small amount of saltwater onto the nose and it will connect to the monitoring machine. This machine senses very small electrical voltages that are generated by the body. It does not and cannot send electricity or shocks to the subject. A measurement is made and then the fluid pumped into the nose is changed to one containing a drug called amiloride. Amiloride changes the makeup of salt transported in the nose and reduces the electrical voltage. Then the fluid is changed to saltwater that does not contain chloride. The fluid is then changed to one that has the drug isoproterenol. Isoproterenol causes the cells in subjects without CF to move chloride. The doses of amiloride and isoproterenol used in this study are much lower than those typically used in patients for other reasons. Finally, the fluid will be changed to one containing the experimental drug Genistein. Subject will then be randomized and given a 4-day supply of the study drug. Visit 2, subject will have safety evaluations and NPD performed in the same manner as previous visit. No more study drug after this visit. Visit 3, subject will have safety evaluations and NPD performed without the perfusion of Genistein.

Cystic Fibrosis

null

2

arm 1: The standard oral adult dose is 20 g/day for 4 days. Every participant will receive Genistein during the NPD. arm 2: The placebo is given to match the active comparator for 4 days. Every participant will receive Genistein.

[ 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: The standard oral adult dose is 20 g/day (tablets) for 4 days. intervention 2: Every participant will be administered a perfusion of 50 MicroM of Genistein (Unconjugated Isoflavones 100) during the modified NPD procedure. intervention 3: The placebo is given to match the active comparator for four days.

intervention 1: Sodium 4-Phenylbutyrate intervention 2: Genistein (Unconjugated Isoflavones 100) intervention 3: Placebo

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00590538

[ 3 ]

19

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate

null

Essential Tremor

null

3

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

[ 0, 0, 2 ]

3

[ 0, 0, 10 ]

intervention 1: Dose 1 intervention 2: Dose 2 intervention 3: Dose 3

intervention 1: Sodium Oxybate intervention 2: Sodium Oxybate intervention 3: Placebo

1

Bingham Farms | Michigan | United States | -83.27326 | 42.51587

0

NCT00598078

[ 4 ]

381

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease

This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease

Early Stage Parkinson's Disease

Rotigotine Neupro®

null

1

arm 1: Rotigotine

[ 0 ]

1

[ 0 ]

intervention 1: Rotigotine trans-dermal patches, once daily: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours); Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours. After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.

intervention 1: Rotigotine

63

Concord | N/A | Australia | 151.10381 | -33.84722 Darlinghurst | N/A | Australia | 151.21925 | -33.87939 East Gosford | N/A | Australia | 151.35338 | -33.43874 Westmead | N/A | Australia | 150.98768 | -33.80383 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Vienna | N/A | Austria | 16.37208 | 48.20849 Brussels | N/A | Belgium | 4.34878 | 50.85045 Hoboken | N/A | Belgium | 4.34844 | 51.17611 Zagreb | N/A | Croatia | 15.97798 | 45.81444 Brno | N/A | Czechia | 16.60796 | 49.19522 Ostrava | N/A | Czechia | 18.28204 | 49.83465 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Espoo | N/A | Finland | 24.6522 | 60.2052 Kuopio | N/A | Finland | 27.67703 | 62.89238 Lappeenranta | N/A | Finland | 28.18871 | 61.05871 Oulu | N/A | Finland | 25.46816 | 65.01236 Pori | N/A | Finland | 21.78333 | 61.48333 Aix-en-Provence | N/A | France | 5.44973 | 43.5283 Caen | N/A | France | -0.35912 | 49.18585 Toulouse | N/A | France | 1.44367 | 43.60426 Aachen | N/A | Germany | 6.08342 | 50.77664 Dresden | N/A | Germany | 13.73832 | 51.05089 Kiel | N/A | Germany | 10.13489 | 54.32133 Marburg | N/A | Germany | 8.77069 | 50.80904 Budapest | N/A | Hungary | 19.04045 | 47.49835 Miskolc | N/A | Hungary | 20.77806 | 48.10306 Pécs | N/A | Hungary | 18.23083 | 46.0725 Hadera | N/A | Israel | 34.9039 | 32.44192 Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Milan | N/A | Italy | 12.59836 | 42.78235 Padua | N/A | Italy | 11.88586 | 45.40797 Pozzilli | N/A | Italy | 14.06252 | 41.51142 Breda | N/A | Netherlands | 4.77596 | 51.58656 Geldrop | N/A | Netherlands | 5.55972 | 51.42167 Auckland | N/A | New Zealand | 174.76349 | -36.84853 Christchurch | N/A | New Zealand | 172.63333 | -43.53333 North Shore | N/A | New Zealand | 174.75 | -36.8 Wellington | N/A | New Zealand | 174.77557 | -41.28664 Stavanger | N/A | Norway | 5.73332 | 58.97005 Trondheim | N/A | Norway | 10.39506 | 63.43049 Gdansk | N/A | Poland | 18.64912 | 54.35227 Katowice | N/A | Poland | 19.02754 | 50.25841 Krakόw | N/A | Poland | N/A | N/A Lublin | N/A | Poland | 22.56667 | 51.25 Mosina k/Poznania | N/A | Poland | N/A | N/A Olsztyn | N/A | Poland | 20.49416 | 53.77995 Warsaw | N/A | Poland | 21.01178 | 52.22977 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Barcelona | N/A | Spain | 2.15899 | 41.38879 Pamplona | N/A | Spain | -1.64323 | 42.81687 Karlstad | N/A | Sweden | 13.50357 | 59.3793 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Bern | N/A | Switzerland | 7.44744 | 46.94809 Lausanne | N/A | Switzerland | 6.63282 | 46.516 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Blackpool | N/A | United Kingdom | -3.05 | 53.81667 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 London | N/A | United Kingdom | -0.12574 | 51.50853 Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328 Swansea | N/A | United Kingdom | -3.94323 | 51.62079

0

NCT00599196

[ 4 ]

1,067

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

Acne Vulgaris

Acne Vulgaris Adapalene

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks intervention 2: Vehicle will be applied topically to the face, once a day, for 12 weeks

intervention 1: Adapalene lotion 0.1% intervention 2: Adapalene Lotion Vehicle

34

0

NCT00599521

[ 0 ]

17

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

This study will evaluate the effectiveness of adding guided self-help group therapy to a weight loss program in achieving weight loss and reducing binge eating in overweight binge eaters.

Binge eating disorder is one of the most common eating disorders, with more than 4 million Americans affected. Following a binge eating episode, in which a person eats an excessive amount of food in a short period of time, the person often experiences feelings of guilt, depression, embarrassment, and disgust. Beyond the emotional distress caused by binge eating, people who binge eat are at a higher risk for more serious health problems associated with weight gain. These health problems may include high blood pressure, diabetes, heart disease, high cholesterol, and certain types of cancer. Thus, seeking effective treatment for binge eating disorder is vital to an affected person's overall physical and mental well-being. Managed weight loss programs, combined with certain forms of psychotherapy, have shown success in providing the direction and proper motivation to eat healthily and to prevent future binge eating episodes. This study will evaluate the effectiveness of adding guided self-help group therapy to the alli weight loss program in achieving weight loss and reducing binge eating in overweight binge eaters. Participation in this single-blind study will last 36 weeks. Initial assessments will be divided over two 1- to 2-hour sessions. These assessments will include a history of any medical illness, height and weight measurements, and an eating disorder evaluation. Participants will also answer several questionnaires about self-esteem, feelings of depression, and emotion and eating. Participants will then be randomly assigned to one of two treatment groups: the alli program with the use of the weight loss drug orlistat or the alli program with the use of orlistat plus guided self-help group psychotherapy. All participants will take the over-the-counter weight loss medication orlistat three times a day for 12 weeks in conjunction with the alli program, a comprehensive weight loss program with online access. Participants assigned to the psychotherapy group will also attend 12 weekly guided self-help group psychotherapy sessions. These sessions will include behavioral support for adapting to the lifestyle changes promoted by the alli weight loss program. All participants will undergo 12 weeks of active participation, 18 weeks of maintenance, and 18 weeks of follow-up. At various intervals during the first 6 months of the study, participants will answer a short group of questions concerning current binge eating habits; adherence to prescribed food, activity, and medication plan; and emotional state. The initial assessments will be repeated at Weeks 12, 30, and 42.

Overweight Eating Disorders

Binge Eating Orlistat Alli Guided Self-Help

null

2

arm 1: Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy arm 2: Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone

[ 0, 1 ]

2

[ 5, 0 ]

intervention 1: Emotion regulation guided self-help group therapy involves twelve 2-hour sessions of guided self-help group psychotherapy. intervention 2: The orlistat/alli program involves taking 60 mg orlistat three times a day and participating in the alli program, a comprehensive behavioral weight loss program with online access.

intervention 1: Emotion regulation group therapy intervention 2: Orlistat/alli program

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00601354

[ 0 ]

23

NA

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

true

1FEMALE

true

Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology called Positron Emission Tomography (PET), which is a method used to take pictures of the body, in this case, the brain. Study participants will undergo two baseline PET scans on the first day of the study. The women who have recovered from anorexia will then be given a medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th week, they will return for a third PET scan. By comparing the brain scans, before and after fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the serotonin receptors in the brain. We will be comparing brain serotonin system in women who have recovered from anorexia before and after medication in order to gain a better understanding of changes in the serotonin system associated with eating disorders. This study may help shed light on how to make fluoxetine a more effective treatment for anorexia nervosa.

null

Anorexia Nervosa

eating disorders anorexia nervosa anorexia PET brain imaging serotonin fMRI Prozac fluoxetine

null

1

arm 1: Participants recovered from anorexia nervosa before and after administration of fluoxetine

[ 0 ]

1

[ 0 ]

intervention 1: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.

intervention 1: Fluoxetine

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00603018