New study seeks to understand how the brain optimizes walking in older adults
The purpose of this study is to understand how people control walking and balance. We are looking for healthy older adults who are interested in joining the study. Participants will walk on a treadmill while using an interactive display that will help them modify their walking pattern. We will determine how these modifications influence oxygen consumption during walking and measures of balance.
An ACromegaly, open-label, multi-CEnter, Safety
monitoring program for treating patients with SOM230
(pasireotide) LAR who have need to receive medical
therapy (ACCESS)
Purpose and rationale: The present study is planned as an expanded treatment protocol to provide acromegalic patients for whom medical therapy is appropriate access to
pasireotide LAR (long acting release) while regulatory approval for pasireotide is sought.
Intervention: Pasireotide LAR 40 mg i.m. depot injection every 28 ( 2) days, administered at the
investigative site follow with safety accessment including Monitoring and recording (SAE),
hematology, blood chemistry (including fasting glucose), liver
function parameters, coagulation parameters, HbA1c, free T4, thyroid-stimulating
hormone (TSH), serum cortisol, plasma adrenocorticotropic hormone (ACTH),
urinalysis, physical examination including vital signs and body weightm 12-lead ECGs , Gallbladder ultrasound.
Objectives
- To document the safety of pasireotide LAR in patients with acromegaly
- To document the overall safety and tolerability of pasireotide LAR in patients
with acromegaly
Study population/Sample characteristics: It is expected that approximately 40 adult male and female patients with active
acromegaly for whom medical therapy is appropriate will be enrolled. Eligible
patients must have demonstrated elevated (>1.3 x ULN) circulating IGF-1
concentrations (age- and sex-adjusted) and random GH concentration >1 g/L
within 28 ( 2) days prior to screening.
Study Methodology: Patients will be treated until pasireotide LAR becomes commercially available and
reimbursed or until 31 December 2015, whichever occurs first. Patients will be
transitioned to commercial pasireotide LAR as quickly as possible (no longer than
6 months) after commercial availability.
Phytoserms for menopause symptoms and age associated memory decline
Background and rationale:Selective estrogen receptor (ER) targeting may be a novel therapeutic target for the development of therapies for a range of conditions including cognitive impairment and age-related ovarian failure (menopause). There are plausible mechanisms by which ER receptor stimulation could lead to improved cognition, feelings of well being, reduced risks for cognitive impairment and improved vasomotor symptoms.A formulation composed of rationally-selected ER-selective phytoestrogens (phytoSERMs) was developed that provides a greater effect than the various food supplements ("nutraceuticals") that are mixtures with both ER and ER selective components. This formulation is composed of content that includes synergistic rather than antagonistic effects on estrogen receptors and could likely generate salutary therapeutic effects. The formulation enhances ER responses by adding equol to genistein and daidzein in equal amounts moderating potencial influences of inter-individual differences in the production of equol. Advantages of the formulation are: (1) reduction of antagonistic interactions that occur in complex soy-derived isoflavone preparations; and (2) minimization of adverse effects associated with ER activation in reproductive tissues. Thus, it may serve as an alternative to current over-the-counter therapies.Primary objectives and pupose:To examine in a randomized, placebo-controlled trial of 12 weeks duration evidence for safety, improved cognitive performance and vasomotor symptoms for a specific phytoSERM formulation Secondary objectives:1. To assess single-dose pharmacokinetics of the three constituents of phytoSERM combination over 24 hours in a subset of 18 participants randomly assigned 100 mg, 50 mg, or placebo tablets.2. To assess safety, tolerability of a 100 mg and 50 mg daily dose compared to placebo over 4 weeks3. To assess potential efficacy indicators of phytoSERM combination on cognitive performance and vasomotor symptoms by means of a 4-week treatment, 2 period, placebo-controlled crossover design for a subset of participants4. To develop biomarkers for response (i.e., for peripheral lipid peroxidation and mitochondrial function)Study design:Two stage, dose-range, double-blinded, parallel-group, placebo-controlled adaptive design 12 week treatment duration trial; with an embedded 2-period, 4-week treatment, crossover design for a subset of participants; and an embedded single-dose, 24 hour, pharmacokinetic study for a subset of participants. Allocation ratio will initially be 1:1:1, 100 mg, 50 mg, and placebo dose for the first 36 participants, with a possible change in allocation based on the adaptation (see protocol)Study endpoints:Adverse events over the first 4 weeks, and over 12 weeks;Cognitive performance on a 6-test battery, vasomotor symptoms, and behavioral symptoms at 4, 8, and 12 weeks.Blood levels of the three constituents of phytoSERM combination over 24 hours in the subset in the pharmacokinetic study; and blood levels at 4, 8 and 12 weeks for all participantsBlood for biomarker development at baseline, 4, 8, and 12 weeksEligibility criteria:Generally healthy, peri to postmenopausal women, ages 45 to 60, intact uteri and ovaries, last natural menstrual cycle completed from 60 days to less than 4 years prior to screening, having at least 1 cognitive complaint and 1 vasomotor-related symptom per day (on the Memory Assessment Questionnaire and Greene Climacteric Scale). Intervention:Oral tablets consisting of equal parts genestein, daidzein, and S-equol) totaling 100 mg per tablet and 50 mg per tablet; and mathching placeboProcedures and data collection: At baseline, physical exam, neuropsychological tests, vasomotor symptoms and mood scales;In person visits for screening, baseline, weeks 4, 8, and 12 during which medication effects will be assessed, cognitive and behavioral tests performed, and blood for plasma levels and biomarkers obtained; Telephone contacts at weeks 1, 2, 6, and 10; An in-person visit or telephone contact at 16 weeks (4 weeks after discontinuation); Blood samples for drug levels and pharmacokinetics during the first 24 hours for the subset participating;Blood at baseline, weeks 4, 8, and 12 for drug levels and biomarker development for the whole sampleStatistical considerations:Two-stage adaptive design. Analysis of first stage at 4 weeks after 36 participants are randomized and followed: Primary analysis will use Generalized Estimating Equation (GEE) methods to assess group differences in the outcomes in a modified intent-to-treat sample (i.e., randomized, took at least one dose, and had at least one follow-up with outcomes measures. Observed cases (at least 80% compliant and completed all outcomes) will be assessed in secondary analyses
Join a USC Study on Vaping and E-Cigarette Use
<p>The number of people who vape and use e-cigarettes has been increasing, particularly among young adults. We want to examine how factors associated with vaping and e-cigarette use, such as flavoring and nicotine level, effect people's thoughts, feelings, and behaviors.</p><p><br></p>
A pilot study of safety and adequacy of pancreatic lesion biopsy (Spy Bite)
The purpose of this study is to determine the safety and effectiveness of an experimental technique to obtain biopsies of pancreatic lesions. This technique uses biopsy forceps, which are small jaw-like devices that open and close, to also obtain tissue samples for examination and diagnosis. The biopsy forceps will pass through the endoscope that is already in place for the endoscopic ultrasound guided fine needle aspiration procedure, and an additional biopsy will be taken. This technique is experimental because biopsy forceps are routinely used in gastrointestinal endoscopy, but are not routinely used to obtain biopsies of the pancreas.
A Clinical Research Study for Adults Living with Stable Vitiligo
<p>The purpose of this study is to evaluate the safety and effectiveness of a procedure using the RECELL® System for repigmentation of stable vitiligo. Stable vitiligo means that for at least 12 months: </p><p>• Areas affected by loss of pigment have not increased in size. </p><p>• No new areas with pigment loss have developed. </p><p>The RECELL System is used to prepare a suspension (a liquid solution) of skin cells using a small sample of your own pigmented skin. The suspension made using your own skin includes cells responsible for pigmentation and will be applied on a depigmented area of your skin.</p>
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