Clinical trials: sponsored by Wake Forest University Health Sciences
Nutrient Deficiency
PROmega Pilot Study of Clinic-based DHA Blood Screening in Early Pregnancy
This pilot study will explore feasibility of routine implementation of the recommended blood-based screening of DHA status in early pregnancy in routine clinical care.
- Trial name
- PROmega (NCT07271758)
- Testing
- DHA blood screening
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Wake Forest University Health Sciences
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
The goal of this study is to learn whether children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma can be safely discharged from the hospital at slightly higher methotrexate blood levels after…
- Trial name
- NCT07560826
- Testing
- High-dose Methotrexate
- Where
- 9 sites in United States
- Volunteers
- 46 people
- Sponsor
- Wake Forest University Health Sciences
Tourette Syndrome, Tic Disorders
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
This study adapts and tests PRISM (Promoting Resilience in Stress Management), a short skills-based program that teaches resilience, for teens ages 12-18 with Tourette syndrome or persistent tic disorder.
- Conditions
- Tourette Syndrome, Tic Disorders, Persistent (Chronic) Motor or Vocal Tic Disorder
- Trial name
- PRISM-TS (NCT07905898)
- Testing
- PRISM Intervention, Usual care intervention
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Wake Forest University Health Sciences
Cancer, Young Adult Cancer
Comprehensive Care for AYA: Needs Assessment Survey
The goal of this observational study is to assess gaps in education about exercise, sexual health, fertility, survivorship, financial issues, interpersonal relationships, and clinical trial participation among adolescents and…
- Conditions
- Cancer, Young Adult Cancer, Adolescent Cancer
- Trial name
- NCT07196241
- Testing
- Survey using a questionnaire.
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Wake Forest University Health Sciences
Breast-milk
Breast-milk Enema Administration to Stimulate Passage of Meconium
Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP).
- Trial name
- BEAM (NCT07661992)
- Testing
- breast milk
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Wake Forest University Health Sciences
Sarcoma
LCI-SAR-BSTS-CTDNA-001: Circulating Tumor DNA Liquid Biopsy and Spectroscopy-based Molecular Urinalysis in Sarcoma Patients
The purpose of this research study is to see how well Low Pass Whole Genome Sequencing (LP-WGS) can detect circulating tumor deoxyribonucleic acid (ctDNA) in the blood of participants who have bone or soft tissue sarcoma (type of…
- Trial name
- NCT06958107
- Testing
- Non-Metastatic and Resectable, Metastatic and Un-resectable, No evidence of disease, under surveillance
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Wake Forest University Health Sciences
Traumatic Injury
Pediatric and Caregiver Traumatic Stress Intervention (PACTS)
The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression.
- Trial name
- PACTS (NCT06366282)
- Testing
- Caregiver Counseling for Childhood Traumatic Injury, Standard of Care for Childhood Traumatic Injury
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Wake Forest University Health Sciences
Weight Loss, Pediatric Obesity
Dyad Plus Effectiveness/Feasibility
The purpose of this research is to determine the effectiveness of a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase…
- Conditions
- Weight Loss, Pediatric Obesity, Overweight Adolescents, Parent-Child Relations
- Trial name
- NCT04036331
- Testing
- Brenner FIT Standard, By Design Essentials, Dyad Plus
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Wake Forest University Health Sciences
Congenital Mullerian Duct Anomaly
Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
In this Phase 1, single site, clinical trial, Vulvar/vaginal Smooth muscle cells (SMC) and Epithelial Cells (EPC) are isolated from autologous patient's biopsy
- Trial name
- TEV (NCT05675722)
- Testing
- biologic vaginal-construct implantation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Wake Forest University Health Sciences
Dermatologic Disease
A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis
Consented patients will have three images taken of their dermatologic conditions within the Belle.ai software. These images will be uploaded and saved within the Belle software system where a single AI-generated differential list…
- Trial name
- NCT07033169
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Wake Forest University Health Sciences
Total Parenteral Nutrition-induced Cholestasis
Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin.
- Trial name
- NCT02929303
- Testing
- Omegaven IV lipid emulsion
- Where
- United States
- Sponsor
- Wake Forest University Health Sciences
Intubated Patients
Pilot Study of the Sage Guard for Oral Cavity Protection
The study will evaluate how safe the device is and how easy it is for healthcare providers to use in patients receiving care in the Intensive Care Unit (ICU).
- Trial name
- NCT07806812
- Testing
- Sage Guard oral protection device
- Sponsor
- Wake Forest University Health Sciences
Pediatric Cancer
Pharmacogenomic Testing in Pediatric Hematology/Oncology Patients
Pharmacogenomic (PGx) testing involves analyzing variants of genes associated with drug metabolism, transport and medication targets.
- Trial name
- NCT06744712
- Testing
- Pharmacogenomic Testing
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Wake Forest University Health Sciences
Conductive Hearing Loss
Evaluation of Flexible Conductive Hearing Aids
Conductive hearing loss (CHL) is the most common type of hearing loss among the pediatric population. CHL occurs when sound is not properly transmitted from the external ear to the cochlea, and congenital pathologies like…
- Trial name
- NCT07222202
- Testing
- flexible conductive hearing aid
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Concussions
COmmunities Aligned to Reduce Concussion and Head Impact Exposure
Head impacts in collision sports such as football are a public health concern, as repetitive head impacts, even if a concussion is not suspected, have negative effects on brain health.
- Trial name
- COACH (NCT06624202)
- Testing
- COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention
- Where
- United States
- Volunteers
- 880 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Population Genomic Screening Implementation Best Practices
Facilitating the Implementation of Population-wide Genomic Screening
This is a multi-site hybrid implementation-effectiveness trial that uses a stepped-wedge cluster randomized design to evaluate the impact of the FOCUS toolkit, a multicomponent implementation guide, on improving the…
- Trial name
- FOCUS (NCT07806643)
- Testing
- FOCUS Toolkit Training
- Where
- 7 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Atopic Dermatitis
Opzelura Experience Study
Atopic dermatitis is a common multifactorial skin disease. Topicals are the mainstay of treatment, but adherence to topicals is often abysmal, possibly worsened by the complexity of recommended treatment algorithms.
- Trial name
- NCT07661979
- Testing
- ruxolitinib, ruxolitinib and an Eczema Action Plan
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Wake Forest University Health Sciences
Traumatic Brain Injury
Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics
To improve patient selection for head CT, a safe and high sensitivity screening neuroimaging modality is needed. Currently many clinicians must make treatment decisions based solely on the patients clinical exam, which has low…
- Trial name
- CUPID-Peds (NCT06697808)
- Where
- United States
- Volunteers
- 169 people
- Sponsor
- Wake Forest University Health Sciences
Malignant Neoplasm, Metastatic Malignant Neoplasm in the Bone
Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis
This randomized phase II trial studies how well palliative radiation therapy works in reducing pain in patients with cancer that has spread from the original (primary) tumor to the bone (bone metastasis).
- Conditions
- Malignant Neoplasm, Metastatic Malignant Neoplasm in the Bone, Pain
- Trial name
- NCT02699697
- Testing
- External Beam Radiation Therapy, Palliative Radiation Therapy, Quality-of-Life Assessment
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Wake Forest University Health Sciences
Asthma
Primary Care Implementation and Evaluation of Coach McLungs
The goal of this study is to evaluate the implementation of the Coach McLungsSM shared decision making (SDM) intervention into primary care across a large healthcare system.
- Trial name
- NCT05059210
- Testing
- Coach McLungs Intervention
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Wake Forest University Health Sciences