A Phase 2 Study of Veliparib (ABT-888) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients With Newly Diagnosed High-Grade Glioma (HGG) Without H3 K27M or BRAFV600 Mutations Save

Date Added
April 24th, 2020
PRO Number
Pro00099128
Researcher
Jacqueline Kraveka

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Profiles_link
Keywords
Brain, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with newly diagnosed High-Grade Glioma (HGG). The investigational drug in this study is veliparib. The purpose of this study is to see if veliparib given with radiation therapy followed by veliparib with temozolomide given as maintenance therapy works better than treatments that have been tried in the past. Participants can expect to be in this study for about 1 year and be followed for up to 10 years.

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

Assessing Effectiveness and Implementation of a Perioperative Enhanced Recovery Protocol for Children with Inflammatory Bowel Disease Save

Date Added
March 25th, 2020
PRO Number
Pro00098243
Researcher
Robert Cina

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Profiles_link
Keywords
Pediatrics, Surgery
Summary

This study will implement and evaluate the Enhanced Recovery in Children Pathway (ENRICH-P) for pediatric patients with inflammatory bowel disease. Participants (or participants' parent) will be asked to complete quality of life surveys pre-operatively and up to 6 weeks after surgery.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment Save

Date Added
February 26th, 2020
PRO Number
Pro00093213
Researcher
Aaron Lesher

List of Studies

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Keywords
Pediatrics, Surgery
Summary

To evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-18 years) with thermal burns of 1-30% total body surface area as compared to standard of care. Patients enrolled in this trial will undergo daily assessments in hospital after their treatment until they are discharged. They will then have weekly follow-ups until completed wound closure. Once this is achieved, there will be a 6 week, 12 week, 6 month, 12 month, 18 month, and 24 month follow up visit.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis Save

Date Added
February 11th, 2020
PRO Number
Pro00092458
Researcher
Kelli Williams

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Silhouette
Keywords
Esophagus, Pediatrics
Summary

The main purpose of this study is to see if taking dupilumab is effective in treating Eosinophilic Esophogitis (EoE). The study will determine if dupilumab is an effective treatment compared with placebo in adult and adolescent patients. Dupilumab is administered through a subcutaneous injection (shot). Dupilumab is is an investigational drug, which means that it is not yet approved to treat EoE. Participation in the study will last up to 48 weeks.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-8352
wakefies@musc.edu

ATHN 9: A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People With Severe Von Willebrand Disease (VWD) Save

Date Added
January 27th, 2020
PRO Number
Pro00092790
Researcher
Stephanie Ambrose

List of Studies

Keywords
Adolescents, Blood Disorders, Children's Health, Circulation, Dental, Genetics, Infant, Joint, Men's Health, Minorities, Muscle, Non-interventional, Nose, Obstetrics and Gynecology, Pain, Pediatrics, Periodontal Disease, Rare Diseases, Rheumatoid, Surgery, Women's Health
Summary

ATHN 9 is a natural history study to assess the safety of various Von Willebrand Factor (VWF) regimens for different indications (on-demand, surgery and prophylaxis) in adult and pediatric participants with clinically severe congenital VWD.

Institution
Palmetto
Recruitment Contact
Shannon Cearley
803-434-4088
shannon.cearley@prismahealth.org

A Phase 3 Trial Investigating Blinatumomab ( NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphoma (B-LLy) Save

Date Added
January 22nd, 2020
PRO Number
Pro00095606
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lymphoblastic Lymphoma (B-LLy). The investigational drug used is Blinatumomab. The purpose of this study is to determine in a randomized manner if the addition of 2 cycles of blinatumomab to standard therapy improves disease-free survival (DFS) in patients with SR B-ALL and higher risk features (SR-High), and patients with standard-risk average (SR-Avg) B-ALL who are negative for minimal residual disease (MRD) by flow cytometry but have detectable or indeterminate MRD as measured by high-throughput sequencing (HTS) at end of Induction (EOI). Participants can expect to receive treatment on this study for about 2 years. After treatment, participants will be followed-up with every year for about 10 years.

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

Effect of Clonidine on High Volume-Low Concentration Caudals Save

Date Added
January 21st, 2020
PRO Number
Pro00091670
Researcher
Christopher Heine

List of Studies


Profiles_link
Keywords
Pediatrics
Summary

The purpose of this study is to evaluate the effect a commonly used medication named clonidine has on the length of caudal nerve blocks. A caudal nerve block is an injection in the tailbone area to provide pain control after surgery.

Institution
MUSC
Recruitment Contact
Wanda Jones
8437921869
joneswr@musc.edu

A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared with the RECELL® Device Compared to Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1 ? 16 Years) Save

Date Added
January 13th, 2020
PRO Number
Pro00092124
Researcher
Steven Kahn

List of Studies

Silhouette
Keywords
Adolescents, Pediatrics, Skin, Surgery
Summary

The purpose of the study is to see if use of the RECELL device will help heal your
partial-thickness burn faster and decrease the need for skin grafting compared with a standardized wound dressing. The data collected in this current study will provide additional information about the safety and effectiveness of the RECELL® device for treatment of partial-thickness burns. The duration of each participant will last up to 12 months. Visits will include photograph documentation of the wound and various health assessments.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants Save

Date Added
December 10th, 2019
PRO Number
Pro00091762
Researcher
Carol Wagner

List of Studies


Profiles_link
Keywords
Children's Health, Infant, Pediatrics
Summary

Babies that are born extremely prematurely are at higher risk of developing chronic (long term) lung disease (CLD) and other complications (problems). The purpose of this study is to test the safety and effectiveness of an investigational drug called mecasermin rinfabate (rhIGF-1/rhIGTBP-3) or SHP607. The researchers want to find out if SHP607 can help reduce the risk of chronic lung disease in babies born prematurely and if it can help reduce the risk of other complications.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu

AALL1732-A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy Save

Date Added
December 6th, 2019
PRO Number
Pro00093700
Researcher
Stuart Cramer

List of Studies

Keywords
Cancer/Leukemia, Pediatrics
Summary

This phase III trial studies how well inotuzumab ozogamicin and post-induction chemotherapy work in treating patients with high-risk B-cell lymphoblastic lymphoma (B-ALL), mixed phenotype acute leukemia, and B-lymphoblastic lymphoma (B-LLy). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, cytarabine, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, thioguanine, vincristine, and pegaspargase, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Institution
Palmetto
Recruitment Contact
Christine Spicer
803-434-4034
christine.spicer2@prismahealth.org

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