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NCT00450281
RATIONALE: Studying samples of blood and tissue from smokers (closed to entry as of 7/15/07) and non-smokers with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about risk factors for lung cancer and may help the study of cancer in the future. PURPOSE: This clinical trial is studying carcinogens in lung tissue from smokers (closed to entry as of 7/15/07) and non-smokers with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.
NCT01145547
Background: Post-prandial hyperglycemia is common in people with type 1 diabetes. Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring. Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low GI; in the other, high GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. Each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.
NCT00840112
Purpose: People with a genetic defect in the ability to burn fat can also develop a problem with the nerves in their feet. The nerve problem, or neuropathy, can limit their ability to walk. Part of the treatment of their genetic defect in the ability to burn fat is to eat a very low fat diet. Vitamin E is found only in fatty foods like oils and nuts. People with a genetic defect in the ability to burn fat may have low vitamin E because of their low fat diet. The purpose of this study is to test whether vitamin E supplements can improve the nerve function in the feet of people with a genetic defect in the ability to burn fat. Procedures: Blood samples will be drawn at the beginning of the study, after 2 months and after 6 months of vitamin E supplements. The blood will be analyzed for plasma vitamin E concentrations. Around the time of each blood draw subjects will record all the food and beverages he or she consumes for three days. The subject will send the record to the investigator. Subjects will have a physical exam by a doctor specializing in nerves, a neurologist before and after taking vitamin E. They will have nerve function measured with a test called a nerve conduction velocity or NCV. Subjects will be given 800 international units (IU) of vitamin E per day for 6 months.
NCT00150241
The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.
NCT00110019
This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate 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. It is not yet known whether giving carboplatin and paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel in treating melanoma.
NCT01460953
1. Briefly describe the purpose of this protocol: This study is designed to evaluate the effectiveness of an educational training video on the topic of health literacy for medical students. 2. Briefly summarize how participants are recruited: OHSU medical students attending mandatory trainings on the topic of health literacy during the 1st and 2nd years of medical school will be invited to participate in the study. 3. Briefly describe the procedures subjects will undergo: Completion of a short self-administered anonymous survey before and after viewing a 23-minute video about health literacy. 4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test questionnaire and 13-item post-test questionnaire designed to assess individuals' knowledge about health literacy, and intended clinical practices with respect to health literacy. 5. If this is a clinical trial using an experimental drug and/or device, or an approved drug and/or device used for an unapproved purpose, briefly describe the drug and/or device: n/a 6. Briefly describe how the data will be analyzed to address the purpose of the protocol: Demographics and responses to individual items will be reported as frequencies and percentages within the sample. The investigators will use a chi-square analysis to stratify responses by demographic groups and t-tests to measure possible changes over time.
NCT00531505
1. Briefly describe the purpose of this protocol. First purpose of the study is to understand the inheritance of morbid obesity. 2. Briefly summarize how participants are recruited. Volunteers will first learn of LABS-2a research opportunity at the Bariatric Surgery Informational meetings. 3. Briefly describe the procedures subjects will undergo. Participants will be asked to complete a set of memory tests. Fat and Liver samples will be removed during their weight loss surgery, specifically for this research study. 4. If applicable, briefly describe survey/interview instruments used. Memory tests will be performed to assess cognition. 5. Briefly describe how the data will be analyzed to address the purpose of the protocol. The memory test data collected and compared against well established norms. Tissue samples will stored in a repository to be genetically studied for an indefinite amount of time. Genetic studies will be related to the disease of obesity and associated comorbidities brought on by the disease.
NCT01150357
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.
NCT00437073
This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.
NCT00022074
RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes. PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.
NCT00020657
RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy. PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.
NCT01966679
This study is a NIMH-funded multi-site clinical trial that includes UCLA as the coordinating site, with Emory University and Seattle Children's Hospital, as other recruiting sites, and the Nathan Kline Institute as the Data Management Center. The purpose of the study is to examine the effects of an investigational drug, AZD7325, as a potential treatment for high-functioning adults 18 -35 years old with Autism Spectrum Disorders (ASD). The primary study measures are effects on brain waves as measured by non-invasive brain wave recordings (electroencephalograms or EEGs), assessments of side effects, and measures of attention and learning. The study drug, AZD7325, is manufactured by Astra Zeneca, and was initially tested as a medication for anxiety disorders in over 488 subjects, but was not pursued for marketing due to too few benefits for anxiety. AZD7325 was found to have a very good safety profile and was tolerated by the majority of subjects. AZD7325 has some similar actions to currently marketed anxiety drugs in the benzodiazepine class, but lacks the sedative and negative effects on attention of the benzodiazepines. The study drug is designed to target the GABA neurotransmitter system which is believed to be abnormal in this population. There are 2 study phases. Phase 1 includes the recruitment of 24 healthy volunteers without mental disorder (6 per site) in order to establish normal EEG reference ranges. Controls will only be seen for one study visit which includes a clinical evaluation, physical exam, routine blood tests, and an EEG. Once control recruitment is complete, Phase 2 will begin. Phase 2 involves the recruitment of 40 adults (10 per site) 18 - 35 years old with a diagnosis of ASD, normal intelligence, and specific EEG patterns compared to control values. Screening for eligibility will be performed in one visit, which includes a clinical evaluation, tests of learning and intelligence, blood and urine tests, and an EEG. Those subjects who are found to be eligible will be enrolled in a 6-week medication study. Subjects with ASD who are enrolled will be randomly assigned to receive the study drug AZD7325 or placebo in matching capsules. Subjects will be seen weekly by study physicians and clincians for the 7 study visits, including 3 additional EEG recordings, and then for a final follow-up visit (9 total visits including screening lasting up to 11 weeks to complete). Study physicians can adjust the dose of study medication to reduce any side effects.
NCT01383486
A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.
NCT01727713
The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
NCT01125189
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.
NCT01149044
This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.
NCT01262456
The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.
NCT00428168
This is a randomized, double-blind, placebo-controlled, multicenter, multinational study. Approximately 78 subjects (39 per treatment group) will be randomized into this 16 week study. A screening visit will be used to determine subject suitability for inclusion in the trial. Within 7 days of the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned to 1 of the following 2 treatment groups: * Olanzapine OD plus betahistine 24 mg BID (48 mg/day total), * Olanzapine OD plus matching placebo BID. Double-blind treatment will continue for 16 weeks. During this period, olanzapine dosage will be determined according to the discretion of the treating physician. In addition, 5 study visits (at 2, 4, 8, 12, and 16 weeks) will take place. Study medication (betahistine or matching placebo) will be administered BID (in the morning and together with olanzapine in the evening). The primary statistical hypothesis to be tested is that the mean change from Baseline to Week 16 will be different between the treatment and placebo groups
NCT01128166
The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.
NCT01833065
12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation.