A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications

Date Added
August 16th, 2011
PRO Number
Pro00011805
Researcher
Robert Stuart

List of Studies


Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
•Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
•Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients

Date Added
July 3rd, 2012
PRO Number
Pro00017387
Researcher
Jennifer Jaroscak

List of Studies


Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

This study if for patients that have a blood disease and it's been determined that the best option for treating that blood disease is a cord blood transplant. Cord blood (CB) is blood that is taken from the umbilical cord and placenta of healthy newborn babies after childbirth. The cord blood collected from a newborn baby is called a cord blood unit. The United States Food and Drug Administration (FDA) considers cord blood to be a biological drug. These are considered "investigational" products. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Validation of computer-based saccade measures as a sensitive, reliable, and freely available biomarker for tracking subtle neurocognitive changes in Parkinson's disease

Date Added
March 28th, 2014
PRO Number
Pro00031260
Researcher
Travis Turner

List of Studies


Keywords
Parkinsons
Summary

We will ask 80 patients with Parkinson's disease, representing the full spectrum of motor and cognitive symptoms, to participate. Participation will include measurement of eye movements using two methods: the new computer-based saccade battery and the best available video-based eye-tracking equipment. The evaluation will be repeated about 30 days later. Data will be analyzed to determine whether the computer-based tasks are reliable and able to provide the same quality of information as the gold standard in eye-tracking. A comparison sample of 80 healthy older adults will also complete the behavioral saccade tests in order to establish normative data that will enable application in clinical settings.

Institution
MUSC
Recruitment Contact
Travis Turner
619-788-3079
turnertr@musc.edu

A Randomized Clinical Trial Comparing The Overall Adverse Event Rate Of Inguinal Hernia (IH) Repair Prior To NICU Discharge Versus IH Repair After NICU Discharge And Beyond 55 Weeks Post Conceptual Age In Premature Infants.

Date Added
March 17th, 2015
PRO Number
Pro00041985
Researcher
Aaron Lesher

List of Studies


Keywords
Children's Health, Surgery
Summary

The Hernia in Premies (HIP) Trial is a multi-site randomized clinical trial that is comparing two accepted treatment choices, surgery before or after neonatal intensive care unit (NICU) discharge, for inguinal hernia (IH) repair in premature infants. The reason we are doing this study is that surgeons and neonatologists currently do not know the best time to perform the hernia repair. Some providers recommend having the hernia fixed before discharge from the neonatal intensive care unit (NICU) and some believe waiting until after NICU discharge is better. Both treatments are standard options for IH repair in premature infants. Also, all babies that have IH repair receive anesthesia. We also do not know if the age of the child receiving anesthesia affects neurodevelopment. We are comparing the timing of anesthesia exposure between the two treatments (IH repair before or after NICU discharge) to help answer these questions.

By volunteering to take part in the HIP Trial, your child will be randomly assigned to have the operation before or after NICU discharge. This means that the timing of the repair operation will be determined by chance, like flipping a coin, and he/she has an equal chance of being treated before or after NICU discharge. We will be collecting information about your baby and the treatment that he or she receives, and how your baby recovers before and after the surgery. We will also collect information about your baby from clinic notes and results from your baby's routine 2 year follow-up neurodevelopmental testing, where your child will be asked questions that measure cognitive, language, social and motor development. We will stop collecting information about your baby and your participation will end when your child is 2 years old. There are no extra medical tests or blood work being done for research purposes in the HIP trial.

Institution
MUSC
Recruitment Contact
Aaron Lesher
843-792-3853
leshera@musc.edu

EEG/fMRI Controlled TMS Real-time Neural Feedback in Anti-Depressive Treatment

Date Added
April 7th, 2015
PRO Number
Pro00042072
Researcher
Truman Brown

List of Studies


Keywords
Healthy Volunteer Studies, Mental Health
Summary

This study proposes to design and build a neural imager/stimulator which will let us obtain information about brain circuits and pathways by acquiring electrical and fMRI signals from the brain at the same time. By adding magnetic stimulation to the instrument we will be able to perturb these circuits at precise times and locations in order to both improve how TMS is used as an anti-depression treatment as well as to better understand how our brains function. This research has the potential to revolutionize our understanding of how best to use TMS as a treatment as well as learning how our brains function. This study simply proposes to develop the combined instrument. The use of the new instrument as a anti-depressive treatment will be presented independently after we have developed a working instrument.

Institution
MUSC
Recruitment Contact
Alana McMichael
843-876-2465
EEGTMSproject@musc.edu

Determining the best dose of electroconvulsive therapy (ECT): comparing seizure threshold titration with two different fixed currents (600 mA vs. 900 mA)

Date Added
June 2nd, 2015
PRO Number
Pro00044575
Researcher
Mark George

List of Studies


Keywords
Depression
Summary

Over the past 30 years we have discovered that both the efficacy and the side effects of ECT come not only from the induced seizure, but by the currents of electricity and where they go in the brain. In all patients we now determine, at the first treatment session, the minimum dose of electricity needed to produce a seizure. This is called the seizure threshold. Subsequent treatments are then given at 6 or 9 times this number. The method of titrating has not been fully explored. We propose to titrate with two different currents, one of which is much lower than standard clinical practice. We need to do this twice in each patient, on the first and second treatment sessions, and compare the difference. If we find that that lower currents are paradoxically better, then this will change ECT practice around the world. Patients will receive less overall electricity, with likely fewer side effects.

Institution
MUSC
Recruitment Contact
John Henderson
843 876 5142
henderjs@musc.edu

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation

Date Added
October 13th, 2015
PRO Number
Pro00048303
Researcher
Praneeth Baratam

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with acute myelogenous leukemia (AML) . The investigational drug in this study is AG-120. The purpose of this study is to identify and test the highest dose of AG-120 that can be given safely. Participants can expect to be in the study for as long as the study doctor feels it is in the participants best interest.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

Apixaban for the Reduction of Thrombo-Embolism in patients with Device-Detected Sub-Clinical Atrial fibrillation

Date Added
June 27th, 2017
PRO Number
Pro00067386
Researcher
Michael Gold

List of Studies


Keywords
Cardiovascular
Summary

The purpose of this study is to determine which treatment is best for preventing stroke or systemic embolism in patients who have experienced at least one episode of SCAF (sub-clinical atrial fibrillation) detected by their pacemaker or ICD (intracardiac defibrillator) or ICM (insertable cardiac monitor) and also have other risk factors for stroke. Subjects will be randomly assigned to one of the two treatment strategies: apixaban or aspirin. Neither the subject nor the researcher will know which treatment the subject is assigned. Follow-up visits will occur every six months until the end of the study.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Improving Quality of Care in Child Mental Health Service Settings

Date Added
July 5th, 2017
PRO Number
Pro00066446
Researcher
Kenneth Ruggiero

List of Studies


Keywords
Adolescents, Mental Health
Summary

We recently completed an NIMH R34 in which we piloted a patient- and provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) – a treatment that was selected because it addresses a wide range of symptoms using techniques shared by other treatments for emotional and behavioral disorders. The tablet-based toolkit consists of numerous components (e.g., videos, interactive games, drawing applications) that are designed to facilitate provider-patient interactions in a way that enhances children's engagement and supports adherence to the treatment model. The tablet-based toolkit was very well received by children, caregivers, and providers in our pilot work. Moreover, all benchmarks for feasibility outlined in our NIMH R34 application were met or exceeded. We now propose to conduct a hybrid effectiveness-implementation trial to examine the extent to which the tablet intervention may improve fidelity, engagement, and children's mental health outcomes. We will conduct a randomized controlled trial with 250 mental health providers and 360 families in partnership with dozens of clinics in the Carolinas and Florida. Providers will be assigned randomly to tablet-facilitated vs. standard TF-CBT. Youth aged 8-16 years with clinically elevated symptoms of PTSD will be recruited. Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted by independent, blind evaluators. Sessions will be videorecorded for observational coding of engagement and fidelity by independent raters blind to study hypotheses. We will also examine costs and conduct semi-structured interviews with families, providers, supervisors, and agency leaders to inform future dissemination and implementation initiatives. Technology-based resources that are scalable, easy to use, and designed for efficient integration into everyday practice may have sustained national impact. The return on investment of these initiatives will ultimately rest on their potential to improve the spread of best-practice treatments and the quality with which they are delivered to the children who need them.

Institution
MUSC
Recruitment Contact
Tonya Hazelton
843-792-2517
hazelto@musc.edu

Randomized Controlled Trial of AboutFace: A Novel Video Storytelling Resource to Improve Access, Engagement, and Utilization of Mental Health Treatment among Veterans with PTSD

Date Added
December 5th, 2017
PRO Number
Pro00072331
Researcher
Anouk Grubaugh

List of Studies


Keywords
Anxiety, Depression, Military, Psychiatry, Stress Disorders
Summary

Behavioral health problems among Veterans have raised awareness of the critical need for more reliable, effective, and accessible ways to recognize those in need, direct them to help, and ensure that they receive the best evidence-based care available. AboutFace is a novel peer education program that features the personal stories of Veterans and is designed to improve Veterans' likelihood of engaging in PTSD specialty care. Using a randomized controlled study design we propose to compare the efficacy of AboutFace relative to standard care for improving treatment engagement and outcomes. Additional data from VA providers will provide valuable information on wide scale implementation and dissemination of AboutFace. If AboutFace increases access of services, data will have broad implications for overcoming barriers to care for Veterans with PTSD and other stigmatized conditions.

Institution
MUSC
Recruitment Contact
Anouk Grubaugh
843-532-6672
grubaugh@musc.edu



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