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NCT ID: NCT05148221 Completed - Sleep Patterns Clinical Trials

Mayo Clinic Family Medicine Resident Wellness Study

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

The objectives of this study are to better understand the association between sleep characteristics (sleep disruptions and deprivations) during overnight shifts and mental fatigue among medical residents, and to explore the feasibility of a virtual, tailored exercise program on sleep characteristics, subjective mental fatigue, and burnout level among residents in family medicine.

NCT ID: NCT05148000 Completed - Clinical trials for Glabellar Frown Lines

Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines

Start date: January 23, 2023
Phase: Phase 3
Study type: Interventional

This study to assess aesthetic improvement following treatment with QM1114-DP.

NCT ID: NCT05147922 Completed - Ventilatory Failure Clinical Trials

Neo RQI: The Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training Skills Retention

Start date: April 18, 2022
Phase: N/A
Study type: Interventional

This is a prospective multicenter randomized control trial to assess percentage mask leak six months post instructor led positive pressure ventilation skills training in providers who undergo booster training compared to those who do not undergo any booster training

NCT ID: NCT05147428 Completed - Alzheimer Disease Clinical Trials

A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease

D-PRESCRIBE-AD
Start date: June 21, 2022
Phase: N/A
Study type: Interventional

Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of educational interventions designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans.

NCT ID: NCT05147402 Completed - Pharmacokinetics Clinical Trials

Food Effects on Bioavailability of MDMA in Healthy Volunteers

MPKF
Start date: July 28, 2022
Phase: Phase 1
Study type: Interventional

This protocol is a Phase 1 open-label study with a primary purpose of evaluating the food effect of a high calorie meal as compared to fasting conditions on the relative bioavailability of oral MDMA capsules in healthy volunteers. In addition, increases in heart rate are anticipated following MDMA administration. Therefore, the secondary purpose of this study is to evaluate the effect of food on the safety and tolerability of oral MDMA, as well as MDMA effects on electrocardiogram (ECG). Directly comparing the pharmacokinetics of MDMA and its active metabolite MDA, in a within-subject crossover study will allow for assessment of any impacts of food and inform product labeling.

NCT ID: NCT05147389 Completed - Clinical trials for Common Bile Duct Neoplasms

Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis

Start date: October 1, 2020
Phase:
Study type: Observational [Patient Registry]

Digital single-operator cholangioscopy (DSOC) findings achieve high diagnostic accuracy for neoplastic bile duct lesions. To date, there is not a universally accepted DSOC classification. Endoscopists' Intra and interobserver agreements vary widely. Cholangiocarcinoma (CCA) assessment through artificial intelligence (AI) tools is almost exclusively for intrahepatic CCA (iCCA). Therefore, more AI tools are necessary for assessing extrahepatic neoplastic bile duct lesions. In Ecuador, the investigators have recently proposed an AI model to classify bile duct lesions during real-time DSOC, which accurately detected malignancy patterns. This research pursues a clinical validation of our AI model for distinguishing between neoplastic and non-neoplastic bile duct lesions, compared with high DSOC experienced endoscopists.

NCT ID: NCT05147337 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Safety and Tolerability of E2511 in Healthy Adult and Elderly Participants

Start date: December 1, 2021
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety, tolerability, and plasma pharmacokinetic (PK) of E2511 following multiple oral doses in healthy adult participants.

NCT ID: NCT05147324 Completed - Type 1 Diabetes Clinical Trials

"MyPlan" - Individualized Planned Eating Patterns for Adolescents With Type 1 Diabetes

Start date: December 13, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to test the acceptability and effectiveness of an individualized eating strategy as part of diabetes self-management to improve glycemic levels among youth with type 1 diabetes (T1D) and suboptimal glycemic management. Investigators will assess participant acceptability of and adherence to a 6-month individualized eating strategy ("MyPlan") characterized by approximate day-to-day consistency in the frequency and timing of meals and snacks and distribution of carbohydrate throughout the day. Within-individual change in glycemic levels between baseline and 6-months of the study will also be compared. The goal of the study is to inform the design of a future randomized clinical trial to test the addition of the MyPlan eating strategy to ongoing diabetes clinical care among youth with T1D.

NCT ID: NCT05147129 Completed - Clinical trials for Vulvar Lichen Sclerosus

Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus

Start date: September 16, 2021
Phase:
Study type: Observational

Vulvar lichen sclerosus (LS) is a chronic inflammatory disease, often diagnosed at late stages after scarring has obliterated normal vulvar architecture and severely affected a woman's quality of life. First line therapy for vulvar LS is ultrapotent topical steroids. If left untreated, this condition can cause complete stenosis of the vaginal introitus and 5% of patients may develop squamous cell carcinoma (SCC). Lichen sclerosus is more common in pre-pubertal children and in post-menopausal women suggesting that hormonal shifts may contribute to disease pathogenesis. Small studies in children with LS have also shown that the microbiome is altered in LS. Little is known about the skin microbiota in postmenopausal patients with vulvar LS. To determine if the microbiome is altered in vulvar skin of postmenopausal patients with LS, this study will use 16s sequencing to broadly characterize the microbiota of vulvar skin with LS compared to control vulvar skin. The study team hypothesizes that patients with vulvar LS will have a unique vulvar microbial signature compared to age-matched controls. This study also seeks to elucidate differences in the vulvar microbiome of patients with LS after treatment of their underlying condition. The study team hypothesizes that the vulvar microbiome will change after treatment for vulvar LS. Vulvar dermatoses are an understudied area in dermatology with limited therapeutic options. Innumerable women often suffer in silence with vulvar LS. The long-term goal of this work is to understand factors that contribute to vulvar LS so that intervention may be undertaken before irreversible scarring and SCC develop.

NCT ID: NCT05146999 Completed - Clinical trials for Glabellar Frown Lines

Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines

Start date: May 9, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines