Healthy Minds Volunteer Database
The Healthy Minds Volunteers (http://healthyminds.usc.edu) help research labs at the University of Southern California. These labs are working towards a greater understanding of how aging can affect physical, mental and emotional health. The goal is to learn how we can maintain healthy minds and bodies across our lifespan.
An ACromegaly, open-label, multi-CEnter, Safety
monitoring program for treating patients with SOM230
(pasireotide) LAR who have need to receive medical
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.
- To document the safety of pasireotide LAR in patients with acromegaly
- To document the overall safety and tolerability of pasireotide LAR in patients
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.
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
The purpose of this study is to assess the safety, feasibility, and performance of the C2
Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the
patient will receive a follow-endoscopy to assess stricture formation along with biopsy
Post-operative pain will be noted. Additionally, biopsy samples will be evaluated for the
presence of residual Barrett's Esophagus. Through evaluation of the histological results,
treatment parameters for the ablation of human esophageal epithelium will be better
Evaluations include, but are not limited to the following:
- Deployment ease/scope compatibility.
- Device malfunctions.
- Time of catheter deployment.
- Adverse events.
- Stricture formation at 6 to 8 weeks.
- Patient Pain.
- Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual
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
USC study investigates the benefits or health risks of vaping and smoking
Researchers at USC are seeking study participants who vape or smoke as well as non-smokers in the Los Angeles area. The purpose of the research is to study the health benefits and risks of electronic cigarettes (e-cigs). Your participation will help to better understand the potential effects of e-cigs on the human body.
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.
Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
Male and female subjects aged 18 years or older will be randomized to receive either open
surgical treatment or endovascular treatment. They will be followed for at least 2 years and
up to 4 years and 2 months after treatment to primarily assess survival and major adverse
limb events in the index or treated limb, and secondarily, to determine clinical and cost
effectiveness outcomes after treatment. These outcomes (survival-free of major limb events
and clinical, functional and cost effectiveness) will be compared within two cohorts of
subjects: those with an available single-segment great saphenous vein, and those with an
alternative conduit. The null hypotheses for both cohorts is that there will be no difference
in MALE-free survival between best endovascular therapy and best surgical therapy.
A Multicenter, Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment with Cimzia
This is a multicenter prospective study evaluating the placental transfer of certolizumab pegol (CZP) by measuring concentration of CZP in infants born to mothers who are on this drug during pregnancy. Certolizumab is a drug that is approved for use in Crohn's disease, rheumatoid arthritis and ankylosing spondylitis. Recent evidence suggests that certolizumab pegol does not cross the placenta, unlike other anti-tumor necrosis factor drugs. The primary objective of this study is to assess whether there is transfer of CZP across theplacenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants. Blood samples will be measured in the infant, mother, and umbilical cord at birth. Additionally, blood samples will be collected from the infant at Week 4 and Week 8 after birth in order to assess the pharmacokinetics (PK) of CZP in infants after birth. The secondary and exploratory objectives are to assess the concentrations of CZP, anti-CZPantibodies, and polyethylene glycol (PEG) in the 3 sources of blood samples at the time of birth(infant, mother, and umbilical cord) and in the infants at 4 weeks and 8 weeks after birth. Although this study is noninterventional regarding treatment with CZP, it is consideredinterventional due to the collection of blood samples that are not part of routine clinical practice.The study will only include pregnant women who have decided to continue or start treatment withCZP for an approved indication in accordance with their treating physician prior to beingrecruited into the study. Approximately 30 pregnant subjects are planned to be screened in order to enroll 20 subjects (blood samples provided by the mother and infant at delivery/birth). To beeligible to participate in the study, subjects must be 30 weeks pregnant at the start of screening,and expecting to use CZP within 35 days prior to expected delivery date. The primary PK variable is plasma concentration of CZP in the infant at birth. Secondary andexploratory variables include plasma concentrations of CZP, anti-CZP antibodies, and PEG. In addition, safety variables are adverse events (AEs) which will be assessed by a Safety Follow-up phone assessment for mother and infant performed 5 weeks (5 days) after the final sample is obtained. Subjects who withdraw prematurely will have a Safety Follow-Up telephone contact (for mother and infant) 5 weeks (5 days) after withdrawing from the study.
A pilot study of safety and efficacy of spectroscopic diagnosis of pancreatic lesions (Spy Panc)
The objective of this study is to determine if a minimally invasive optical probe can accurately predict a histological diagnosis of dysplastic or malignant tumor cells in solid lesions of the pancreas. If effective, this optical probe would facilitate the detection of malignant and pre-malignant pancreatic lesions. This would lead to more accurate decision-making as to which patients require surgical resection versus patients who should be spared from major surgery.
Molecular Analysis for Therapy Choice (MATCH)
I. To evaluate the proportion of patients with objective response (OR) to targeted study
agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
I. To evaluate the proportion of patients alive and progression free at 6 months of treatment
with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple
II. To evaluate time until death or disease progression. III. To identify potential
predictive biomarkers beyond the genomic alteration by which treatment is assigned or
resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and
imaging-based assessment platforms.
IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes
from pre- through post-therapy imaging can predict objective response and progression free
survival and to evaluate the association between pre-treatment radiomic phenotypes and
targeted gene mutation patterns of tumor biopsy specimens.
STEP 0 (Screening): Patients undergo biopsy along with molecular characterization of the
biopsy material for specific, pre-defined mutations, amplifications, or translocations of
interest via tumor sequencing and immunohistochemistry. Consenting patients also undergo
collection of blood samples for research purposes.
STEPS 1, 3, 5, 7 (Treatment): Patients are assigned to 1 of 35 treatment subprotocols based
on molecularly-defined subgroup. (See Arms Section)
STEPS 2, 4, 6 (Screening): Patients experiencing disease progression on the prior Step
treatment or who could not tolerate the assigned treatment undergo review of their previous
biopsy results to determine if another treatment is available or undergo another biopsy.
Patients may have a maximum of 2 screening biopsies and 2 treatments per biopsy.
STEP 8 (Optional Research): Consenting patients undergo end-of-treatment biopsy and
collection of blood samples for research purposes.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 1 year.
A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma
This is an open label, multi-center, single arm phase II study. The study will investigate
the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of
patients with recurrent or persistent PrR-negative endometrial cancer.
Eligible patients will be enrolled into the study and administered sodium cridanimod in
combination progestin therapy. Objective responses will be assessed at 12 week intervals.
Patients will be treated for a 12 month period, followed by an additional 12 month follow up
period or to disease progression whichever occurs first.
Important objectives of the study are to investigate the effect of sodium cridanimod in
conjunction with progestin therapy on the level of PrR in tumor tissue and how this
correlates to efficacy. To accomplish this objective, some of the patients enrolled in the
study will undergo two tumor biopsies that will allow measurement of PrR levels in the tumor
tissue before the treatment and after 4 weeks of therapy.