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NCT ID: NCT06411535 Recruiting - Gingivitis Clinical Trials

Impact of Ultra-Processed Food Intake on Gingival Tissue Health

Start date: May 21, 2024
Phase: N/A
Study type: Interventional

The shift towards consuming more industrialized food products, particularly ultra-processed foods, has been linked to a rise in non-communicable diseases globally. These products are energy-dense, high in unhealthy components, and often lead to overconsumption due to their palatability and convenience. Studies suggest a connection between ultra-processed food consumption and various health issues, including obesity and cardiovascular diseases. The present study is designed as a single-center, double-blind, parallel-arm randomized clinical trial. This study aims to investigate the impact of ultra-processed food consumption on gingival health and to evaluate the potential benefits of dietary counseling and reduced ultra-processed food intake on gingival inflammation over a 4-month period.

NCT ID: NCT06361771 Recruiting - Sleep Clinical Trials

Evaluation of Invisible Preparation Behaviors of Middle and High School Students in Sports Facilities (PRICELESS)

PRICELESS
Start date: January 8, 2024
Phase:
Study type: Observational

The investigators define the Invisible Preparation (IP) as the set of health behaviors that young athletes implement, on their own, to optimize their health and performances. This includes sleep, nutrition and hydration, physical well-being (injuries prevention) and mental well-being. If some studies have reported a lack of compliance in young athletes regarding sleep and hydration recommendations, the literature is poor in this field. The CMS (Brest Metropolitan Area Sports Medicine Centre, France) aims at preserving the health of young athletes. Prior to their medical examination, the patients will be asked, all along the year 2024, to fill out a form that question them about their health behaviors in the four areas of the IP. Under the direction of the Brest University Hospital, PRICELESS (Invisible Preparation of Middle and High School Students in Sports Institutions) study will try, based on their answers, to estimate the proportion of young athletes who declare adopting the health behaviors recommended in the IP.

NCT ID: NCT06185621 Recruiting - Prevention Clinical Trials

The Effect of Aspirin on Recurrent Acute Pancreatitis

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Recurrent acute pancreatitis (RAP) was defined as two or more occurrences of acute pancreatitis, which was associated with higher percentages of morbidities and mortalities, lower patients' life quality and increased health-care costs. Current interventions, including cholecystectomy and abstain from drinking were reported to be effective methods for preventing the recurrences of biliary and alcoholic etiologies, respectively. However, there were no effective preventions for other etiologies, such as idiopathic etiologies. Non-steroid anti-inflammatory drugs (NSAIDs), including indomethacin, diclofenac and aspirin could inhibiting the inflammatory cascade of pancreatitis. In this study, we aimed at exploring the effects of 100mg aspirin on reducing the occurrences of recurrent acute pancreatitis.

NCT ID: NCT06127498 Recruiting - SARS-CoV-2 Clinical Trials

The Safety and Tolerability of A8G6 COVID-19 Neutralization Antibody Combined With Nasal Spray

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

This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 108 healthy subjects based on inclusion and exclusion criteria. Patients meeting inclusion and exclusion criteria were randomly assigned to one of four different cohorts. Subjects in each cohort were randomly assigned 5:1 to two parallel administration groups, one of which served as a control. Each cohort was given either the experimental drug or placebo by nasal spray at different doses and intervals, and blood was collected on an empty stomach before the first dose. Right nostril and nasal swabs were collected for immunotoxicity, immunogenicity (immunogenicity collection and detection in cohorts 3 and 4 only), and drug concentration detection. Subjects in the first three cohort were required to return to the study Center 3±1 days after the last dose for blood samples, bilateral nostril and nasal swabs for drug concentration, immunotoxicity, physical examination, vital signs, and safety laboratory indicators (blood routine, blood biochemical, and urine routine). Subjects in cohort 4 returned to the study center 7±2 days after the last dose. To evaluate the safety and tolerability of A8G6 COVID-19 neutralization and antibody combined nasal spray in healthy subjects by comparing the test results of subjects in different cohorts, and to study its concentration in serum and nasal swabs in healthy subjects.

NCT ID: NCT06112249 Recruiting - Prevention Clinical Trials

SAFE Workplace Intervention for People With IDD

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

The purpose of this study is to examine the feasibility and efficacy of a systematic training approach targeting behaviors to increase safety and prevention of airborne diseases such as COVID-19 in the workplace for individuals with Intellectual and Developmental Disabilities (IDD). This project is designed to determine proof of concept and proof of product for a peer support intervention, the SAFE program, to increase knowledge and safe workplace practices. There is an identified immediate need for individuals with IDD to receive training in an accessible format. The SAFE program has been developed in an accessible format for those with IDD. It focuses on education regarding actionable behaviors that reduce the risk of acquiring and transmitting COVID-19 and other airborne diseases. The study will implement a peer-mediated and occupational therapy lead program, SAFE, to identify and address potential implementation issues and further refine the program curriculum. Additionally, the efficacy of the program on perceived safety and well-being, observable preventative behaviors and self-advocacy will be examined.

NCT ID: NCT05977101 Recruiting - SARS-CoV-2 Clinical Trials

The Safety and Tolerability of MY-586 COVID-19 Neutralizing Antibody Nasal Spray in Healthy Subjects

Start date: December 17, 2021
Phase: N/A
Study type: Interventional

This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 72 healthy subjects based on inclusion and exclusion criteria. Patients who met the inclusion and exclusion criteria were randomly assigned to one of three different cohorts. Subjects in each cohort were randomly assigned in a ratio of 5:1 to two parallel dosing groups, one of which served as the control group. Each cohort was given either an experimental drug or a placebo nasal spray at different doses and intervals, and blood was collected on an empty stomach before the first dose, and left nasal swabs and throat swabs were collected for immunotoxicity and drug concentration testing. 14 days after the last dose, subjects will return to the study Center for blood samples, left nasal swabs, and throat swabs to be collected for drug concentration, immunotoxicity, and safety laboratory indicators (routine blood and biochemistry). To evaluate the safety and tolerability of MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray in healthy subjects, and to evaluate its serum concentrations and nasal and pharyngeal swab concentrations by comparing the test results of different cotillaries.

NCT ID: NCT05934019 Recruiting - Mental Health Issue Clinical Trials

Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)

EMPATIA
Start date: June 9, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled clinical trial is to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology of adolescents with subclinical symptoms compared to a Care As Usual (CAU) control group. The primary objective is to: - investigate the efficacy of the internet-delivered intervention on general psychopathology of adolescents with subclinical symptoms compared to CAU. - secondary objectives include: clinician-rated interviews and self-report questionnaires on the level of social and role functioning, time until onset of a mental disorder and service use. Furthermore, changes in subclinical symptoms, transdiagnostic mechanisms and therapeutic as well as safety measures are assessed by online self-reports Participants will use the internet-delivered intervention EMPATIA during eight weeks. Researchers will compare intervention group to a Care As Usual (CAU) group to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology.

NCT ID: NCT05903885 Recruiting - Colorectal Cancer Clinical Trials

A Cross-sectional Partnership to Improve Prevention

Start date: October 2, 2023
Phase: N/A
Study type: Interventional

This study is a non-randomized, 2-arm clinical trial comparing the effectiveness of two strategies for distributing FIT (fecal immunochemical test) kits in a community-based colorectal cancer screening program targeting African Americans (AAs). The main questions this study aims to answer are: - Does the on-site distribution of FIT kits result in higher return rates compared to direct mailing? - Which distribution strategy (onsite vs. direct mailing) is a more cost-effective approach for increasing colorectal cancer screening rates among underserved populations? Participants in the study will be African Americans who are eligible for colorectal cancer screening. Participants will be assigned to one of two groups: the on-site distribution group or the direct mailing group. In the on-site distribution group, participants will be given FIT kits at a designated Department of Motor Vehicle (DMV) service location. In the direct mailing group, participants will receive the FIT kits through the mail using the DMV database.

NCT ID: NCT05821946 Recruiting - Clinical trials for Kidney Transplantation

Web-Based Multi-Resource Training on the Prevention of Urinary Tract Infections in Adult Kidney Transplant Recipients

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Purpose: The study aims to examine the effect of web-based multi-source training on the prevention of urinary tract infections in adult kidney transplant recipients on clinical outcomes. Design: The study is a single-center, parallel-group, single-blind, pretest, and posttest randomized controlled experimental study. Methods: A total of 90 kidney transplant recipients, 45 in the control group and 45 in the intervention group will be included in the study. Kidney transplant recipients will be randomized on the day of discharge. Before discharge, the Patient Socio-Demographical/Descriptive Characteristics Form and the Discharge Readiness Scale will be applied to the control and intervention groups. Routine training and aimed at preventing urinary tract infections web-based multi-source training will be provided to the intervention group. The developed educational material was evaluated by experts in terms of literacy, reliability, and information quality. As multiple resources on the web: there will be written and visual texts of the educational material, as well as podcasts and animation videos. Web page usability will be evaluated with the System Usability Scale. Individuals will be able to benefit from each of these multiple educational resources according to their preferences. The control group will be directed to the organ transplantation handbook on the website of the routine education and organ transplant center. After discharge, the follow-ups of the intervention and control group were carried out during the first 6-month post-transplant standard follow-up process of the center (2. day; once a week for the first month; every ten days for up to 1-3 months; every three weeks for the next 3-6 months) will be performed. When patients come to their controls, the results of routine examinations (complete urinalysis, urine culture taken when necessary, hospitalization, emergency application, and other data) will be taken from the Hospital Information Management System. In addition, the recipients' opinions in the intervention group on the Web-Based Multi-Resource Training Program will also be received at the end of the 6th month. The research adhered to the Standard Protocol Items: Recommendations for Interventional Trials-SPIRIT (2013) and Consolidated Standards of Reporting Trials-CONSORT (2018) checklists.

NCT ID: NCT05813080 Recruiting - Psychotic Disorders Clinical Trials

Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders

CARE
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Multicenter randomized controlled trial (RCT) with artificial intelligence (AI)-staged early diagnostics and risk-adapted treatment (RAB) as interventional treatment arm and treatment-as-usual (TAU) as control treatment arm for patients with an increased clinical risk for psychosis.