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NCT ID: NCT06266468 Enrolling by invitation - Diet Quality Clinical Trials

Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children

Start date: February 21, 2024
Phase: N/A
Study type: Interventional

The overall objective of this application is to pilot test an mHealth nutrition intervention within pediatric clinics serving Latino families and evaluate its potential for implementation. The investigators hypothesize the intervention will improve child diet quality and will be feasible for use within the clinic setting. To test this hypothesis, the investigators will pursue 3 specific aims and 1 exploratory aim: 1. Aim 1: Pilot Nutricity with 40 Latino families (English or Spanish speaking) vs. 40 waitlist control in primary care clinics and estimate differences in child diet quality at 3 month's post Nutricity exposure. Preliminary data will inform power calculations for a future larger Nutricity intervention. 2. Aim 2: Evaluate other individual (dyad) level factors including reach, engagement, and changes in secondary effectiveness outcomes (e.g. nutrition literacy, BMI, skin carotenoid, psychosocial constructs) at 3 months post exposure. 3. Aim 3: Evaluate organizational-level factors (adoption, implementation, and organizational-level maintenance) in Latino-serving pediatric clinics that may support or inhibit future uptake of Nutricity. The investigators will seek to understand the context of interventions and scalability to other clinics using mixed methods. 4. Exploratory Aim 1: Explore the relationship among nutrition literacy, psychosocial constructs and diet quality outcomes; and explore how engagement and satisfaction influence outcomes.

NCT ID: NCT06266429 Enrolling by invitation - Surgery Clinical Trials

Metabolomic Profiling of Racial Disparity

Start date: March 12, 2024
Phase:
Study type: Observational

Tonsillectomy ± adenoidectomy (T&A) is one of the most common surgical operations with over 500,000 pediatric T&As performed annually in the United States. Unfortunately, despite advances in anesthetic and surgical techniques, moderate-severe post-tonsillectomy pain (PTP) remains a significant problem affecting up to 62% of children. PTP is thought to arise from pharyngeal mucosal inflammation, which produces local nerve irritation and pharyngeal muscle spasm. Patient factors and surgical techniques also play major roles. Race is an important phenotypic risk factor for moderately severe early PTP. The underlying molecular basis of this differential pain experience is presently unknown. This gap in knowledge means that therapies are poorly targeted and often unsuccessful. Indeed, treatment options for PTP have not advanced substantively for many years. Metabolomics provides novel opportunities to investigate common and unique "metabolic signature" of PTP through the analysis of low molecular weight compounds produced in response to tissue injury. Therefore, the central themes of this proposal are that (1) PTP is a complex process that may be determined by molecular level factors such as preoperative systemic inflammation and metabolic profile, and (2) these molecular level factors may explain the excess burden of PTP among minority children. Here the investigators seek to utilize a combined clinical, biological and untargeted metabolomics approach to identify candidate small and large serum molecules that may influence the frequency and severity of PTP in children across racial groups. This approach to exploring the molecular basis of PTP is novel and knowledge from the study should substantially enhance understanding of the mechanisms underlying pediatric PTP - and narrow the racial disparities in post-operative pain.

NCT ID: NCT06264752 Enrolling by invitation - Acute Kidney Injury Clinical Trials

Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury

MEnD-AKI
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial at eight hospitals within the University of Pittsburgh Medical Center-UPMC system. The project will assess the efficacy of a clinical surveillance system augmented with real-time predictive analytics to support a pharmacist-led intervention delivered to attending physicians (primary service) to reduce the progression and complications of drug-associated acute kidney injury (D-AKI) in hospitalized (non-ICU) adults.

NCT ID: NCT06264609 Enrolling by invitation - Osteoporosis Clinical Trials

Precision Medicine Approach for Osteoporosis - Follow Up Study

Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality. Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781Íž efforts are focused on addressing this particular problem. Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment.

NCT ID: NCT06263855 Enrolling by invitation - Clinical trials for Large Language Model

Effect of Large Language Model in Assisting Discharge Summary Notes Writing for Hospitalized Patients

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This pilot study aims to assess the feasibility of carrying out a full-scale pragmatic, cluster-randomized controlled trial which will investigate whether discharge summary writing assisted by a large language model (LLM), called CURE (Checker for Unvalidated Response Errors), improves care delivery without adversely impacting patient outcomes.

NCT ID: NCT06262282 Enrolling by invitation - Cystic Fibrosis Clinical Trials

Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria

POSTSTAMP
Start date: February 5, 2024
Phase:
Study type: Observational

About 10 people with cystic fibrosis (CF) and persistent Nontuberculosis mycobacteria (NTM) infection despite treatment will be screened to find out if their NTM infection has at least one mycobacteriophage that is effective in killing the mycobacteria. Individuals who are found to have at least one phage will be offered assistance in pursuing FDA approval for treatment via expanded-access Individual New Drug (IND) for compassionate-use. They will receive phage treatment for 1 year along with their guideline-based antibiotics for NTM. Individuals who are not identified as having a phage match will be followed as they continue to receive guideline based antibiotic therapy for 1 year. All subjects, including those who do not have a phage match will continue to be observed for the duration of the study, or about 1 year.

NCT ID: NCT06257420 Enrolling by invitation - Clinical trials for Myalgic Encephalomyelitis

Rapamycin in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

ME/CFS
Start date: December 11, 2023
Phase:
Study type: Observational

The goal of this observational study is to assess the clinical response and the effect of autophagy function in ME/CFS patients before, during and throughout oral low dose sirolimus (rapamycin) therapy. The main questions this study aims to answer are: - Does rapamycin reduce the overall symptom burden of ME/CFS and does it improve the quality of life? - Does rapamycin change mTOR driven autophagy deficits observed in a subset of ME/CFS patients? Participants will be asked to complete a series of questionnaires and quality of life instruments before starting rapamycin therapy prescribed by their physician and throughout their course of treatment. Study blood samples will be collected before starting therapy and throughout the course of treatment to assess serological markers of autophagy.

NCT ID: NCT06255496 Enrolling by invitation - Clinical trials for Post Partum Hemorrhage

QStat Cartridge in Obstetric Patients

Start date: May 9, 2024
Phase:
Study type: Observational

This study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

NCT ID: NCT06254144 Enrolling by invitation - Clinical trials for Depressive Disorder, Major

Neuroimaging Study for Decoding Emotional States and Identifying Neural Circuits to Disengage From Negative Thinking

RNT-decoding
Start date: January 10, 2024
Phase:
Study type: Observational

The purpose of this study is to decode different thinking states from the brain activation patterns and identify the neural circuits that disengage from these thinking patterns using functional magnetic resonance imaging (fMRI) measurement in individuals with major depressive disorder.

NCT ID: NCT06253507 Enrolling by invitation - Clinical trials for Chronic Granulomatous Disease

pCCLCHIM-p47 (Lentiviral Vector Transduced CD34 Plus Cells) in Patients With p47 Autosomal Recessive Chronic Granulomatous Disease (AR-CGD)

Start date: June 26, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Chronic granulomatous disease (CGD) is a genetic disorder. People with CGD are missing a gene that affects their white blood cells. White cells are part of the immune system, and people with GCD are vulnerable to many infections. Researchers want to test a new treatment to replace the missing gene that may be safer than the current treatment for CGD. Objective: To test a new type of gene therapy in people with CGD. Eligibility: People aged 3 years or older with CGD. Design: Participants will undergo apheresis: Blood will be collected through a tube attached to a needle inserted in a vein; the blood will run through a machine that separates certain cells (stem cells); the remaining blood will be returned to the body through a second needle. The participant s stem cells will be modified in a laboratory to add the gene they are missing. Participants will stay in the hospital for about 40 days. For the first 10 days, they will undergo many exams, including imaging scans and tests of their heart and lung function. They will receive drugs to prepare their bodies for the gene therapy. They will receive a "central line": A hollow tube will be inserted into a vein in the chest, with a port opening above the skin. This port will be used to draw blood and administer drugs without the need for new needle sticks. For the gene therapy, each participant s own modified stem cells will be put into their body through the port. Participants will have 8 follow-up visits over 3 years.