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Clinical Trials and Studies

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Study Title Principal Investigator
Predicting Ipsilesional Motor Deficits in Stroke with Dynamic Dominance Model
Some stroke patients have severe weakness in one arm and must rely on their less-affected arm for daily activities. Previous research has shown that in some patients, the less-affected arm also experiences weakness due to the stroke. This research is being done to find out if the less-affected arm can be trained to perform faster and better during daily activities. Approximately 180 people will take part in this research study at Hershey Medical Center and University of Southern California.
Recruiting | stroke | Not Multisite
Carolee Winstein, BA, BS, MS, PhD
Testing a new drug to prevent Alzheimer's disease and dementia
<p>Do any of your friends, family, or loved ones have problems remembering or have developed Alzheimer’s disease? The USC Alzheimer Disease Research Center is testing how well a drug may help to prevent the loss of memory. The research team is looking for volunteers (ages 60 to 75) who do not have signs of cognitive problems (meaning that their speech, thinking, and memory are fine compared to other people of the same age). </p><p>If you're eligible and choose to take part, you'll be one of the few people that can join the fight against Alzheimer's disease. But preventing such a disease won't happen overnight. The trial will run for between 5 and 8 years.</p>
Recruiting | Alzheimer's Disease | Not Multisite
Lon Schneider, MD
Testing a new drug to reduce anxiety and agitation in people with Alzheimer's disease and dementia
<p>A person with Alzheimer's often feels anxious or upset easily. They might be restless, unable to sleep or pace back and forth. These problems, called agitation, can keep them from a normal day-and-night routine and might become harmful for your loved one or their caregivers. </p><p>Can FDA-approved medication that treats sadness and anxiety also help with agitation? USC Alzheimer Disease Research Center is looking for volunteers with any form of dementia (Alzheimer's disease) to join our 24-week study of Escitalopram to reduce agitation. </p><p>Volunteers and their caregivers will receive structured and personalized resources and therapies. Participants will receive Escitalopram for 12 weeks, with in-person visits at weeks 3, 6, 9, and 12, and with telephone contacts between in-person visits.</p>
Recruiting | Alzheimer's Disease | Not Multisite
Lon Schneider, MD
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.
Recruiting | vaping | Not Multisite
Ahmad Besaratinia, PhD
Need Help Quitting Cigarettes?
<p>Do you want to quit smoking, but not sure how? Are you having a hard time finding resources to help you take the first step towards quitting?</p><p>The researchers at the USC Health, Emotion, and Addiction Laboratory are&nbsp;looking for cigarette smokers between the ages of 21 and 65 years old who want to kick the habit.</p><p><br></p><p><br></p>
Recruiting | cigarette | Not Multisite
Adam Matthew Leventhal, PhD
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.
Completed | Cimzia® | Multisite
Caroline Hwang
View Research Profile
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.
Recruiting | Gynecologic Cancers | Multisite
Lynda Roman
View Research Profile
Optimizing the Dose of Rehabilitation After Stroke.
Active, not recruiting | Stroke | Not Multisite
Carolee Winstein
View Research Profile
A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma
OBJECTIVES: Primary - Compare the event-free and overall survival of patients with newly diagnosed localized Ewing's sarcoma treated with doxorubicin hydrochloride, cyclophosphamide, vincristine, etoposide, and ifosfamide with vs without topotecan hydrochloride. - Compare the side effects of these regimens in these patients. Secondary - Evaluate initial tumor size as a prognostic factor for event-free survival of these patients. - Evaluate histological response as a prognostic factor for event-free survival of these patients. - Continue evaluation of biologic markers both as related to prognosis and as eventual therapeutic targets via encouraging concurrent enrollment on COG-AEWS02B1. - Evaluate radiologic response by positron emission tomography as a prognostic factor for event-free survival. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≤ 17 vs ≥ 18 years of age) and primary tumor site (pelvic vs nonpelvic [including extra-osseous Ewing's sarcoma]). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3, 7-9, and 13-15; doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 1, 7, and 13; cyclophosphamide IV over 1 hour on day 1 in weeks 1, 7, and 13; and ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4, 10, and 16. Patients undergo local therapy comprising surgical resection in approximately week 18 and/or radiotherapy beginning in approximately week 19. Patients then receive vincristine as above in weeks 19-21, 28-30, 34-36, 40-42, and 46-51; dexrazoxane hydrochloride IV over 15 minutes on days 1 and 2 and doxorubicin hydrochloride as above in weeks 19 and 28; cyclophosphamide as above in weeks 19, 28, 34, 40, 46, and 49; and ifosfamide and etoposide as above in weeks 22, 25, 31, 37, and 43. - Arm II: Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3, 7-9, and 13-16; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 13; cyclophosphamide IV over 30 minutes on days 1-5 in weeks 1 and 13 and IV over 1 hour on day 1 in weeks 7 and 16; ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4 and 10; and doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks 7 and 16. Patients undergo local therapy comprising surgical resection in approximately week 18 and/or radiotherapy beginning in approximately week 19. Patients then receive vincristine as above in weeks 19-21, 28-33, 37-42, and 46-48; topotecan hydrochloride as above in weeks 19, 31, and 40; cyclophosphamide IV over 30 minutes in weeks 19, 31, and 40 and IV over 1 hour in weeks 28, 37, and 46; ifosfamide and etoposide as above in weeks 22, 25, 34, 43, and 49; dexrazoxane hydrochloride IV over 15 minutes on days 1 and 2 in weeks 37 and 46; and doxorubicin hydrochloride as above in weeks 28, 37, and 46. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 528 patients will be accrued for this study.
Withdrawn | localized Ewing sarcoma/peripheral primitive neuroectodermal tumor | Site Unknown
Mason Bond
CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT). A Prospective, Randomized, Postmarket, Pilot Study.
Enrolling by invitation | Arrhythmias | Multisite
Jagmeet Singh
Join a USC Study on Vaping and E-Cigarette Use for Cigarette Smokers
The number of people who vape&nbsp;and use e-cigarettes has been increasing, particularly&nbsp;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.
Recruiting | smoking | Not Multisite
Adam Matthew Leventhal, PhD
ENRICH: A Multi-center, Randomized, Clinical Trial Comparing Standard Medical Management to Early Surgical Hematoma Evacuation Using Minimally Invasive Parafascicular Surgery (MIPS) in the Treatment of Intracerebral Hemorrhage (ICH).
The ENRICH trial will compare the outcomes between early surgical intervention using the BrainPath® Approach (i.e., MIPS) and a medically managed cohort. The integrated surgical approach includes a combination of available technologies, including the FDA-cleared NICO BrainPath® for non-disruptive access and NICO Myriad® to achieve the goal of maximum clot evacuation. The medically managed cohort will be treated according the Clinical Standardization Guidelines (CSG) as adapted by Emory University from the 2015 AHA/ASA Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Clinical efficacy will be determined by demonstrating a 10% improvement in functional outcome, as determined by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS). Data suggests improved mortality rates and potential functional benefits of surgical ICH evacuation. The methodology proposed for this trial was tested in a preliminary series of 39 patients treated for supratentorial spontaneous ICH and retrospectively reviewed (Labib et al.). These results were replicated in a single center retrospective series of 18 patients (Bauer et al.). Despite positive results of both studies and the widely accepted benefit of the BrainPath Approach (i.e., MIPS) for subcortical lesions, stronger evidence supporting the use of these techniques in ICH is needed for the technique to become universally validated.
Recruiting | Subcortical Intracerebral Hemorrhage | Site Unknown
Gustavo Pradilla
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