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NCT ID: NCT05995340 Recruiting - Atrophic Acne Scars Clinical Trials

ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars

Start date: November 21, 2023
Phase: Phase 3
Study type: Interventional

Visit the study website https://dawnacnescarstudy.com/ACT for more information. Atrophic acne scars are flat, indented or with an inverted center scars that develop at the endpoint of the normal healing process for acne. Acne scarring that remains after acne resolves has a significant impact on health related quality of life, including reduced self-esteem and embarrassment/self consciousness. ELAPR002f provides an immediate space-occupying effect for filling in the scar tissue. The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars. ELAPR002f Injectable Gel is an investigational device being developed for the treatment of facial atrophic acne scars. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to the saline control group. Around 156 adult participants with moderate to severe atrophic acne scarring on both cheeks will be enrolled in the study in approximately 12 sites in Germany and Canada. Participants will receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline control and will be followed for up to an additional 12 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05994976 Recruiting - Atopic Dermatitis Clinical Trials

Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers

Start date: October 17, 2023
Phase:
Study type: Observational

The purpose of the study is to collect different samples for molecular characterization of inflammatory skin diseases.

NCT ID: NCT05994625 Recruiting - Anastomotic Leak Clinical Trials

Economic Evaluation of Stream™ Platform

CostAL
Start date: December 6, 2023
Phase: Phase 3
Study type: Interventional

This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional trial. The purpose of this study is to evaluate the economic and patient outcomes of using the Stream™ Platform for early detection of anastomotic leakage after gastrointestinal surgery. The trial will track patient outcomes and healthcare costs in two groups: the intervention group, where the Stream platform is deployed, and the control group, before the integration of the Stream™ Platform. The data collected from both groups will be compared to assess the impact of implementing the Stream™ Platform and early leak detection on overall patient outcomes and healthcare costs.This trial will include hepatobiliary, colorectal, and trauma/acute care patient populations.

NCT ID: NCT05994599 Recruiting - Contraception Clinical Trials

Comparative Bioavailability Study of Ethinyl Estradiol/Etonogestrel Vaginal Ring

Start date: July 28, 2023
Phase: Phase 1
Study type: Interventional

Single Dose Crossover Comparative Bioavailability Study of Ethinyl Estradiol/Etonogestrel Vaginal Ring (Delivering 0.015 mg/0.12 mg Per Day) Worn for 21 Days in Healthy Female Subjects

NCT ID: NCT05994521 Recruiting - Cancer Gi Clinical Trials

Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers

INTERCEPT
Start date: April 9, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to investigate the effectiveness and safety of Prophylactic EUS-gastroenterostomy (ProEUS-GE) as a preventative approach for malignant gastric outlet obstruction (MGOO) in men and women aged 18 years or older diagnosed with periampullary cancer. The main question this study aims to answer is can ProEUS-GE effectively prevent the occurrence of MGOO in patients with periampullary cancer? Patients will be randomly assigned to one of two groups: Group 1 (ERCP alone) or Group 2 (ERCP + ProEUS-GE). The study will compare the outcomes between these groups to determine the effectiveness of ProEUS-GE in preventing MGOO. Researchers will compare Group 1 (ERCP alone) with Group 2 (ERCP + ProEUS-GE) to see if the addition of ProEUS-GE leads to a reduced occurrence of MGOO in patients with periampullary cancer. The primary endpoint is the rate of malignant gastric outlet obstruction.

NCT ID: NCT05994443 Recruiting - Preterm Labor Clinical Trials

Fetal Brain Growth - Pilot Study

Start date: June 8, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational prospective study is to explore the feasibility of measuring fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed to threatened preterm labor (TPTL) and antenatal corticosteroids (ACS) compared to non-exposed fetuses. Patients with singleton pregnancies on our site with repeated ultrasound measurements every 4 weeks will be evaluated for fetal brain development. The exposed group is defined as patients with a dual exposure of TPTL and ACS. The non-exposed group will be composed of patients who did not have TPTL and ACS. Therefore, patients will have a maximum of 5 additional visits (4 that will occur prenatally and 1 postnatal visit).

NCT ID: NCT05994027 Recruiting - Clinical trials for Parent-Child Relations

ATTACH™ Online Platform: Helping Children Vulnerable to Early Adversity

ATTACH™
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Addressing the impact of early childhood adversity (e.g., family violence, parental depression, and low income) can promote children's mental health and development, giving children the best start in life and reducing societal health inequities. Family violence, depression, and low income undermine parent-child relationship quality linked to mental health and developmental problems in children that tend to persist over the lifespan. Parents' reflective function (RF), i.e., the capacity to understand their own and their child's thoughts, feelings, and mental states, can strengthen parent-child relationships and buffer the negative impacts of early adversity on children. Investigators have developed and tested an effective intervention program called ATTACH™ (Attachment and Child Health) for parents and their preschool-aged children at-risk of early adversity. In research with 90 families, investigators found the intervention significantly improved RF, parent-child relationship quality, and children's mental health and development. When COVID-19 prevented in-person intervention at the same time as demand soared for ATTACH™, investigators developed and pilot tested (n=10) an Online platform or "platform" with our community partners, including parents, to deliver the program virtually. The purpose of the study is to propose an effective implementation hybrid (EIH) Type II study of the ATTACH™ Online platform. Co-primary objectives evaluate clinical intervention effectiveness and implementation strategy feasibility of the ATTACH™ Online platform in naturalistic, real-world settings delivered by community partner agencies serving families affected by early adversity in Alberta.

NCT ID: NCT05993351 Recruiting - Concussion, Brain Clinical Trials

Objective Concussion Assessment Using MRI and Metabolomics

Start date: August 11, 2023
Phase:
Study type: Observational

Mild traumatic brain injury (mTBI), also referred to as concussions, affect millions of people around the world and can cause harmful long term effects. Unfortunately, concussions can be hard to diagnose and many people have lasting post-concussion symptoms such as headaches, difficulty concentrating, and light sensitivity. Recent studies have shown that advanced magnetic resonance imaging (MRI) techniques can identify subtle brain changes caused by a concussion. This study aims to track concussions over time measuring MRI brain scans and post-concussion symptoms to gain a better understand how the brain is affected in comparison to symptoms.

NCT ID: NCT05993013 Recruiting - Accidental Falls Clinical Trials

Improving Strength and Balance Through Exercise With LudoFit

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

The goal of this mixed methods cohort study is to explore how an innovative game-based, technology-enabled home exercise software compares to a conventional home-based exercise program in older adults at risk for falls. The main question[s] it aims to answer are: - Does the exercise software lead to better or similar adherence to exercise recommendations compared to the conventional exercise program? - Does the exercise software improve user strength and balance, as measured by relevant physical function scores? - Do participants find the exercise software enjoyable and acceptable? Participants will be approached during their initial fall risk assessment to see if they are interested in taking part. Those who agree to participate will choose either the exercise software or the conventional exercise program and will be instructed to: - Perform their respective exercise program for a minimum of 3 times a week for 3 months. - Return to clinic in 3 months to see our C-FAST physiotherapist for reassessment of their relevant physical functional tests. - For conventional exercise program only - Document exercise compliance in an exercise log. - For software program only - Complete a survey regarding the use of the technology. Researchers will compare software-use cohort versus conventional exercise program cohort to see if adherence and physical function scores are comparable.

NCT ID: NCT05992571 Recruiting - Cognition Clinical Trials

Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity

Start date: October 25, 2023
Phase: N/A
Study type: Interventional

People who report subjective memory complaints have a greater risk of developing dementia. Memory issues may be an early warning sign of dysfunctional cerebral glucose metabolism and cerebral blood flow. Interventions that can restore cerebral metabolism and enhance cerebral blood flow may protect against conversion to dementia. Exogenous ketone supplements have been shown rapidly improves brain network function in young adults. Further, infusion studies demonstrate that ketone bodies enhance cerebral blood flow in cognitively normal adults. Whether acute ketone monoester supplementation can improve brain function in adults with subjective memory complaints is currently unknown. This study will investigate the effects of a single ketone monoester dose on resting-state functional connectivity in the default mode network and resting cerebral blood flow in adults with subjective memory complaints.