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NCT ID: NCT05509595 Active, not recruiting - Clinical trials for Fibrous Dysplasia Of Bone

Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia

Start date: December 7, 2022
Phase: Phase 2
Study type: Interventional

Background: Fibrous dysplasia (FD) is a disorder that affects bone growth. Affected bone tissue is weakened, and people with FD are prone to deformities, fractures, and other problems. People with FD may also have low blood phosphate levels. This can make bones even weaker. Better treatments are needed. Objective: To test a study drug (burosumab) in people with FD who have low blood phosphate levels. Eligibility: People aged 1 year or older who have FD and low blood phosphate levels. Design: Participants will visit the NIH 3 times in 48 weeks. Each visit will last 5 to 7 days. Participants will self-inject burosumab under the skin in their belly, upper arm, or thigh. They (or a caregiver) will do this at home 1 or 2 times a month. They will be trained in person on how to inject the drug. Home injections will be guided via telehealth. During NIH visits, participants will have a physical exam with blood and urine tests. They will have x-rays of different parts of their body. They will have a radioactive tracer injected into their vein; then they will have a bone scan. They will have tests to assess their strength, walking, and movement. They will complete questionnaires about their pain, mobility, and fatigue levels. Adult participants may have bone biopsies. These will be done under anesthesia with sedation. Small samples of FD-affected bone will be removed for study. Between NIH visits, participants will go to a local laboratory for blood and urine tests. Child participants will have an additional follow-up visit 2 weeks after the final NIH visit.

NCT ID: NCT05508984 Active, not recruiting - Breast Cancer Clinical Trials

Clinical Outcomes and Patient Satisfaction With Use of the Amma System

Start date: August 22, 2022
Phase:
Study type: Observational

The primary goal is to conduct a pilot evaluation of the Amma device, to determine whether it is feasible to offer as an option for patients within oncology suites within the PH&S system.

NCT ID: NCT05508282 Active, not recruiting - Clinical trials for Parent-Child Relations

Testing an App-Based Approach to Reading and Screen Time Guidance for Parents of Infants

Start date: June 30, 2022
Phase: N/A
Study type: Interventional

The American Academy of Pediatrics (AAP) recommends that parents read to their children as often as possible beginning in infancy and limits on screen time at all ages, yet many families question the value of reading to infants and are uncertain how to do so, and screen time is rising. This proposal is highly relevant to public health in that it involves a "how-to" approach to reading with infants and limiting screen time that is delivered during pediatric well-child visits within an established program (Reach Out and Read) using innovative materials: specially designed children's books and animated educational videos featured in a new mobile app (Reading Bees). It addresses important research gaps, compliments existing programs and empowers families, particularly from underserved backgrounds, to read more interactively and enjoyably with their babies, limit screen time, and improve early literacy skills, relationships and health outcomes.

NCT ID: NCT05507866 Active, not recruiting - Obesity, Childhood Clinical Trials

Evaluation of a Comprehensive School Nutrition Enrichment Intervention (CSNEI) in Rural School Districts

Start date: January 12, 2022
Phase: N/A
Study type: Interventional

Obesity is a significant cause of cancer and cardiovascular disease incidence and mortality, and diabetes incidence among rural communities. Arkansas has the sixth-highest proportion of rural population (~41%),and has the third-highest obesity prevalence (37.4%) in the nation. Arkansas has the third-highest prevalence of obesity for high school students (22.1%) and the fifth-highest prevalence for children ages 10-17 (20.2%). In Arkansas, children in rural areas have very high rates of both food insecurity (26%) and free and reduced lunch eligibility (72.9%). In the study's 6 participating school districts, free and reduced lunch eligibility ranges from 51.4% to 79.3%. School meals are an important opportunity to influence students' nutritional intake and long-term food preferences, which can reduce obesity. A multidisciplinary team has partnered with 6 rural Arkansas school districts which have agreed to participate in a study to evaluate the effects of an evidence-based population-level policy intervention designed to improve the nutritional quality of food served in schools. The study team will conduct a matched-pairs cluster-randomized trial with pre-test and repeated post-tests in 6 rural Arkansas school districts, 3 implementing CSNEI, and 3 matched comparison school districts following their existing nutritional practices. Baseline data collection will take place prior to implementation (Year 1), and follow-up data will be collected annually thereafter (Years 2-5). The study will compare individual-level change in relative body mass index (adjusted for age and sex) and district-level changes in the nutritional quality of food served, amount of food consumed per diner, and fruit and vegetable intake in school districts implementing the intervention compared to matched comparison districts.

NCT ID: NCT05506982 Active, not recruiting - Clinical trials for Malignant Solid Neoplasm

Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain

Start date: November 1, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with demoralization and chronic pain. Cancer patients often experience demoralization, which is characterized by feelings of hopelessness, loss of meaning, and existential distress. Psilocybin psychotherapy, together with multidisciplinary palliative and supportive care, may help treat the anxiety, depression, and chronic pain felt by cancer survivors - defined here as cancer patients from time of diagnosis through the end-of-life.

NCT ID: NCT05506618 Active, not recruiting - COVID-19 Clinical Trials

Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test (ASPIRE-2)

ASPIRE-2
Start date: June 30, 2022
Phase: N/A
Study type: Interventional

Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method

NCT ID: NCT05506254 Active, not recruiting - Clinical trials for Methylmalonic Acidemia

Long-term Follow-up Study of Patients Who Received hLB-001 Gene Therapy

Start date: July 20, 2022
Phase:
Study type: Observational

This is a non-interventional long-term follow-up study of patients who have participated in LogicBio studies for the treatment of MMA and received hLB-001

NCT ID: NCT05505734 Active, not recruiting - Asthma Clinical Trials

A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma

Start date: September 2, 2022
Phase: Phase 3
Study type: Interventional

This is a US study comparing the efficacy and safety of BDA MDI [Budesonide/Albuterol Sulfate (BDA) metered dose inhaler (MDI)] with AS [Albuterol Sulfate] MDI, both are administered as needed for up to 12 months.

NCT ID: NCT05503069 Active, not recruiting - Breastfeeding Clinical Trials

Community Interventions to Improve Breastfeeding

Start date: September 23, 2022
Phase: N/A
Study type: Interventional

The percentage of women breastfeeding their newborn babies is very low among minority populations such as African American women in Mississippi. There are good results with initiatives supporting the initiation of breastfeeding after delivery. However, the percentages of continuation of breastfeeding up to 3, 6 or 12 months are still very low in Mississippi. Therefore, this project is proposing to focus on community interventions including social and cultural components to promote and support continuation of breastfeeding. - The social component will include interventions to promote supportive environments in the workplace for lactating mothers, as well as promoting the use of mother's milk to feed infants in daycare centers. - The cultural component will focus on educating and raising awareness of the benefit of BF to prevent absenteeism at work, to reduce child illnesses, and to promote healthy child development. The cultural component will target the mother with her family and spouse/partner, employers, and daycare managers.

NCT ID: NCT05502302 Active, not recruiting - Cancer Clinical Trials

App-Assisted Day Reconstruction to Reduce Logistic Toxicity in Cancer

Start date: July 28, 2022
Phase:
Study type: Observational

The number of new cases of cancer diagnosed in the U.S. was 1.7 million in 2017 and is expected to increase by 35% to 2.3 million in 2030[1]. Cancer treatments often create numerous logistic challenges in prioritizing and managing treatment and everyday life priorities and how these challenges affect their everyday lives and well-being (hence "logistic toxicity"). However, there are no established reliable tools to monitor patients' logistic challenges and the associated impacts; and logistic toxicity has been largely unaddressed in cancer care delivery. The objective is to develop the first digital health app for cancer patients to continuously monitor logistic toxicity in their daily lives. The app will combine objective data from mobile sensing with subjective self-reported data to form an app-assisted day reconstruction system that captures activity engagement and well-being information associated with cancer treatment-related activities and trips throughout the day.