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NCT ID: NCT04816643 Completed - Clinical trials for SARS-CoV-2 Infection, COVID-19

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

Start date: March 24, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated.

NCT ID: NCT04816630 Completed - Covid19 Clinical Trials

Feasibility Study of Hematology Parameters in COVID-19 Disease

Start date: December 21, 2020
Phase:
Study type: Observational

The purpose of this study is to evaluate the potential for MDW and other CPD parameters (measured with CBC-DIFF) to identify COVID-19 diseased adult individuals presenting to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care includes CBC-DIFF and microbial testing.

NCT ID: NCT04816513 Completed - Healthy Clinical Trials

A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants

Start date: April 14, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.

NCT ID: NCT04816383 Completed - Breastfeeding Clinical Trials

A Smartphone-Based Approach to Improved Breast-Feeding Rates And Self-Efficacy

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

To provide patients with easily accessible information in the form of a smartphone application regarding medically appropriate information about breastfeeding and to assess the impact this information has on women's breastfeeding rates and perception of self-efficacy.

NCT ID: NCT04816188 Completed - Clinical trials for Achilles Tendinopathy

Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification

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

Invesigators plan to conduct a 12-week longitudinal cohort study of 30 subjects with calcaneal apophysitis. Subjects will be included if they are between 7-17 years-old, have experienced an insidious onset of heel pain with running or jumping activities, and have no underlying diagnosis predisposing heel pain and no other injury that limits their ability to run and jump. Parents of subjects will be invited to participate by completing questionnaires related to their perspective of their child's symptoms, physical activity level, quality of life, and their satisfaction with the treatment protocol. Subjects will be asked to attend 4 monthly sessions consisting of evaluation and treatment.

NCT ID: NCT04816175 Completed - Microcephaly Clinical Trials

Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay

Start date: April 30, 2019
Phase: N/A
Study type: Interventional

This trial will consist of a clinical series of up to 50 children with Global Developmental Delay and concomitant microcephaly or hyperkinetic movements. All children will be assessed for psychomotor function using standardized assessments, goal specific assessments, with the potential addition of neuroimaging assessment, prior to and after receiving an intensive burst of neuromotor therapy. The interventional effects will be explored by comparing the pre and post interventional assessments and neuroimaging.

NCT ID: NCT04815993 Completed - Clinical trials for Enteritis Caused by Radiation (Disorder)

Pharmacokinetics, Safety, and Tolerability of SYN-020

Start date: March 22, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK, safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will participate, in each of up to 6 sequential cohorts. Single doses of 5, 15, 45, and 150 mg SYN-020 are planned in Cohorts 1 through 4, respectively. Cohorts 5 and 6, if enrolled, will receive doses that were well tolerated in an earlier cohort to determine the effect of BMI and/or a high-fat meal on the SYN-020 PK profile. For each cohort, eligible subjects will be admitted to the clinic on Day -1, and receive study drug in the morning of Day 1. For PK analysis, blood and feces will be collected before dosing and for up to 96 hours (blood) or 120 hours (feces) after dosing. Subjects will be discharged from the clinic after the End of Study procedures are completed on Day 6.

NCT ID: NCT04815980 Completed - Exercise Clinical Trials

Impact of Pilates on Running Mechanics

Start date: September 8, 2009
Phase: N/A
Study type: Interventional

INTRODUCTION: Core strengthening, balance, and flexibility programs such as Pilates have been advocated to affect running mechanics and prevent lower extremity injuries positively. The purpose of this study was to assess the effects of a 12-week mat-based Pilates exercise program on dynamic knee valgus alignment in runners. METHODS: Thirty-four young male and female adults performed a running protocol at baseline. The protocol consisted of the participants running on a treadmill at a constant five miles per hour (mph) for four minutes. Post-examination, participants were randomly assigned to a Pilates or control group (n=16 and n=18, respectively). A certified Pilates instructor gave the Pilates group a 12-week home-based program. To ensure participants in the Pilates group performed exercises correctly, the Pilates instructor conducted the first session, and provided feedback to each participant. Participants in both groups performed the same running testing protocol every four weeks. Knee valgus was measured as the medial displacement of the knee joint center during the running stance phase. Repeated measures Analysis of Variance (RepANOVA) was calculated at baseline and 4-, 8-, and 12-weeks post examinations to compare knee valgus during running.

NCT ID: NCT04815551 Completed - Cachexia Clinical Trials

A Phase 1 Study of AV-380 in Healthy Subjects

Start date: February 22, 2021
Phase: Phase 1
Study type: Interventional

This double-blinded, placebo-controlled, single ascending dose (SAD) study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy subjects of a single dose of AV-380. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.

NCT ID: NCT04815252 Completed - Clinical trials for Stress, Psychological

Mindfulness Intervention for Early Childhood Educators

CHIME
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

This is a randomized trial of the 'Cultivating Healthy, intentional, Mindful Educators' (CHIME) intervention designed for early childhood educators. The intervention aims to enhance wellbeing, emotion regulation, and sensitive, responsive caregiving among educators by providing them with mindfulness, compassion-based techniques to alleviate stress and respond to emotional challenges in the classroom. The intervention ultimately aims to enhance children's self-regulation through sensitive, responsive caregiving. Measures of teachers' emotional regulation, wellbeing, and stress physiology will be collected pre- and post- the 8 week intervention and compared to a waitlist comparison group. Measures of child self-regulation also will be collected to assess the relation of teacher stress, wellbeing and emotion regulation to child self-regulation.