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NCT ID: NCT05056727 Not yet recruiting - Clinical trials for Renal Insufficiency, Chronic

A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia

STABILIZE-CKD
Start date: September 27, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's glomerular filtration rate [eGFR] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.

NCT ID: NCT05056597 Not yet recruiting - Anorexia Nervosa Clinical Trials

Incentive Processing and Learning in Anorexia Nervosa and Bulimia Nervosa

Start date: January 2022
Phase:
Study type: Observational

The purpose of this study is to investigate areas of the brain responsible for 'liking', 'wanting', and learning in adults with eating disorders using brain imaging techniques, computer tasks, a test meal, and self-report questionnaires and interviews. The investigators will study changes in brain activity using a procedure called functional magnetic resonance imaging (fMRI). This study will include 252 women with an eating disorder (63 AN-restricting type (AN-R), 63 AN-binge eating/purging type (AN-BP), 63 bulimia nervosa (BN)) and 63 healthy controls (HC) aged 18-35. Aim 1: To examine neural differences in 'liking' and 'wanting' in ED relative to HC. Aim 2: To examine differences in instrumental learning for reward and punishment in ED relative to HC. Aim 3: To examine how 'liking' and 'wanting' drive instrumental learning in ED and predict clinical symptoms at baseline and 1 year later. Exploratory Aim: To explore the associations of dopamine function, as measured by neuromelanin MRI (NM-MRI), with ED diagnosis and brain response to 'liking', 'wanting', and learning.

NCT ID: NCT05056493 Not yet recruiting - Clinical trials for Children/Youth With Special Healthcare Needs

Caremap: A Digital Personal Health Record for Complex Care Coordination

Start date: December 10, 2021
Phase: N/A
Study type: Interventional

This study will implement a new mobile application ('app') called Caremap to improve care coordination for patients with complex health needs. The goal is to pilot test the mobile app with patients/families and clinic doctors to gather input on how well the app works and how to make it better. Investigators plan to enroll up to 40 participants from Duke University for this study. The study is sponsored by Duke's Institute for Health Innovation.

NCT ID: NCT05056480 Recruiting - Care Coordination Clinical Trials

Learning Health for Pediatric Complex Care Integration (PCCI)

Start date: March 24, 2021
Phase:
Study type: Observational

The study team will conduct a mixed methods evaluation of the implementation of an evidence-based clinical program -- the Pediatric Complex Care Integration (PCCI) program - for improvement of care integration for children and youth with special healthcare needs (CYSHCN) and children with medical complexity (CMC). The PCCI program is not a discrete intervention itself; rather it is a health system-initiated program that will be implemented as a new standard of care for eligible patients with the intention of improving quality of care, implemented by clinical teams within Duke Health.

NCT ID: NCT05056454 Recruiting - Depression Clinical Trials

New Moms Mood Tracking & Wellbeing

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

New moms can be at risk for perinatal depression (PND). The New Moms Mood Tracking and Wellbeing study is investigating mood changes, risk factors for depression and anxiety and treatment response around the time of delivery. Participants will be asked to complete three sets of online surveys between week 28 gestation and week 20 after delivery, in addition to downloading an app to collect data using their smartphone sensors and brief symptom surveys every other week. Women with elevated symptoms can participate in treatment. Women will be randomized to one of two conditions - Perinatal Psychiatric Care or Screening and Treatment for Anxiety and Depression (STAND). In Perinatal Psychiatric Care, participants will receive appointments with psychiatry clinicians. In STAND, participants will be further allocated to Online therapy with Coaching or Clinical Care, which includes both psychotherapy and psychiatry appointments. Treatment can last up to 6 months and there will be treatment related assessments for the duration of the 6 months, in addition to brief symptom surveys on a regular basis. Therefore, participation can last between 24 and 52 weeks, as both time of delivery and treatment enrollment timepoint cannot be scheduled in advance.

NCT ID: NCT05056376 Not yet recruiting - Obesity Clinical Trials

Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs

Start date: September 22, 2021
Phase: N/A
Study type: Interventional

The purpose of this research study is to compare the effectiveness of a fully automated digital diabetes prevention program to standard of care human coach-based diabetes prevention programs for promoting clinically meaningful lifestyle changes to reduce the risk of type 2 diabetes in adults with prediabetes.

NCT ID: NCT05056311 Recruiting - Hypospadias Clinical Trials

Engaging Families to Improve the Care of Patients With Hypospadias

Start date: June 9, 2021
Phase: N/A
Study type: Interventional

Reconstructive surgery is advocated for most children with hypospadias, a condition in which the pee hold is not in the correct place on the penis, to prevent potentially serious cosmetic and functional problems. Parents faced with a decision about hypospadias repair encounter an irreversible choice with potentially lifelong consequences. Recent studies have identified decisional conflict (DC) and decisional regret (DR) as a significant problem for parents. Several recent guidelines on complex urologic topics suggest that shared decision-making (SDM) is the optimal approach. A pilot test of a decision aid website by parents potentially facing this decision will be conducted to measure pre- and post-outcomes, in order to develop a fuller understanding of how urologists can effectively provide parents with optimal decision support. Parents will answer questions via phone up to four time points, twice before (T1 and T2) and twice after seeing a urologist for a hypospadias referral (T3 and T4). If the urologist diagnoses hypospadias but recommends no surgery, the final data collection point will be three months after the urology visit. If the urologist recommends repair surgery, the final data collection point will be six months after surgery.

NCT ID: NCT05056207 Active, not recruiting - Lymphedema Clinical Trials

PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema

Start date: November 17, 2017
Phase: N/A
Study type: Interventional

This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program.

NCT ID: NCT05056129 Not yet recruiting - Heart Failure Clinical Trials

RCT of Sensor-controlled Digital Game for Heart Failure Self-management

SCDG
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of weight monitoring and physical activity in adults with heart failure (HF). Half of the participants will receive the SCDG app and weight monitoring and physical activity sensors and the other half will receive only the weight monitoring and physical activity sensors.

NCT ID: NCT05056077 Not yet recruiting - Clinical trials for Stage III Rectal Cancer AJCC v8

Improving Nutrition and Physical Activity for Colorectal Cancer Survivors (Tools To Be Fit)

TTBF
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in colorectal cancer survivors. Studies indicate that people with colorectal cancer whose nutrition and physical activity habits are consistent with the American Cancer Society's Nutrition and Physical Activity Guidelines may have longer disease-free survival. The four different intervention components may help patients with colon or rectal cancer adopt recommended health behaviors after they have completed treatment.