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NCT ID: NCT04530929 Completed - Clinical trials for Gastrointestinal Disorder, Functional

Analysis of the Impact of Used Probiotic Strains and Diet on Body Composition, Cardiopulmonary Efficiency and the Incidence of Gastrointestinal Disorders in Runners

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The aim of the study was to assess the diet and the effect of probiotic therapy on reducing the incidence of gastrointestinal disorders and selected parameters determining the inflammation of the body, body composition, cardiopulmonary efficiency and selected serum biochemical parameters. 70 competitors took part in the study. The research was carried out at the Department of Dietetics and Clinical Nutrition (Medical University of Bialystok), Fitness Club Maniac Gym in Bialystok, as well as at the Hematological Diagnostics Department and the Biochemical Diagnostics Department of the University Teaching Hospital in Bialystok. The study was randomized using a double-blind trial. 35 persons selected in the draw were G1 group and the remaining G2 group (n=35). The intervention factor was the SANPROBI BARRIER multi-strain probiotic or placebo. Competitors used probiotic/ placebo for three months at a dose of 2x2 capsules daily (2.5 x 10 9 CFU / g (1 capsule)). The consent of the Bioethics Committee of the Medical University, no. RI-002/81/2017, was obtained for the study. The study consisted of two stages (W1 and W2), and each stage was associated with three visits by the participants. The first of these (W1) included qualification for the study, completing the questionnaire and 3-day nutrition diaries. At the second visit, body composition analysis and cardiopulmonary efficiency test on a medical treadmill were performed. For morphological tests (blood count with smear, lipid profile, fasting glucose, C-reactive protein and ionogram) at the third visit for each competitor was collected blood from the vein in the amount of 10 ml. The final stage (W2) included similar three visits, where the first visit was made after 3 months of taking product A or B. 66 competitors took part in it.

NCT ID: NCT04530591 Completed - Clinical trials for Substance Use Disorders

User Acceptability of a Device-Based Opioid Overdose Intervention

Start date: August 25, 2020
Phase:
Study type: Observational

This pilot study evaluates the needs of opioid users for a device-based intervention for opioid overdoses. The results of this one-time short questionnaire will inform development of a novel naloxone delivery device.

NCT ID: NCT04525469 Completed - Clinical trials for Post Traumatic Stress Disorder

Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy

NET
Start date: February 27, 2019
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations. PTSD during pregnancy has been linked to an increased risk of adverse perinatal and infant health outcomes and may even contribute to racial disparities in adverse perinatal outcomes. Although front-line treatments exist for PTSD, treatment research that specifically focus on pregnancy are extremely limited. Clinical studies examining the safety, acceptability, feasibility, and efficacy of treatments for PTSD during pregnancy are virtually non-existent. Thus, pregnant individuals with PTSD, particularly within low-income communities of color, are a vulnerable and underserved group in need of effective treatment approaches for their distress. Investigators propose to conduct a feasibility and acceptability study of a PTSD treatment, Narrative Exposure Therapy (NET), in a sample of pregnant individuals with PTSD in which low-income people of color are highly represented. Aim 1: The purpose of Aim 1 will be to examine feasibility. Investigators will evaluate the recruitment and assessment procedures. Aim 2: The purpose of Aim 2 will be to examine acceptability. Investigators will evaluate participant feedback of the NET intervention. Aim 3: The purpose of Aim 3 will be to examine the proportion of participants demonstrating clinically meaningful reduction in PTSD and perinatal depression symptoms from pre- to post-treatment. Investigators will aim to enroll up to 30 participants; participation will last up to ten months. Data sources will include questionnaires, electronic medical records, and qualitative feedback interviews. With this study, investigators aim to fill a critical gap in knowledge of how to safely and effectively treat PTSD among a vulnerable and underserved population (i.e., perinatal individuals of color).

NCT ID: NCT04524975 Completed - Clinical trials for Anxiety Disorder Generalized

А Dose-finding Study to Assess the Efficacy and Safety of CD-008-0045 in Patients With Generalized Anxiety Disorder

Start date: October 2, 2018
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, dose-finding pilot study to assess the efficacy and safety of CD-008-0045 in patients with Generalized Anxiety Disorder (GAD). Each patient will participate in the study for the period of approximately 10 weeks: Screening and Run-in period: 1 week; Study Treatment period: 8 weeks; Follow-up period: 1 week.

NCT ID: NCT04524806 Completed - Clinical trials for Temporomandibular Disorder

Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

Start date: July 1, 2013
Phase: N/A
Study type: Interventional

The aim of the study is assessing the effect of the stabilization splint (SS) thickness on the temporomandibular disorder's and their symptoms; such as muscle or temporomandibular joint (TMJ) pain, TMJ sounds, and limitation of mouth opening.

NCT ID: NCT04511767 Completed - Clinical trials for Autism Spectrum Disorder

Reliability and Validity of CCISO for Diagnosis of Autism Spectrum Disorder

Start date: September 1, 2019
Phase:
Study type: Observational

The investigators designed the Child-Caregiver Interaction Observation Scale(CCIOS)to assess social communication behaviors, stereotyped behaviors for children with autism spectrum disorder(ASD) via a 20-min video of interactions between a caregiver and a child. The original CCIOS coding scheme consists 23 items. The score range for each item is 0-4, with higher scores being indicative of more atypical behavior. The aim of the study is to determine items for inclusion in the final CCIOS coding scheme through exploration of item correlations, establish the cutoff score of CCIOS for ASD and evaluate the reliability and validity of CCIOS. The reliability evaluation include test-retest reliability and inter-rater reliability. DSM-5 criterion is used as the gold standard. Validity is assessed by determining the correlation and consistency between CCIOS and DSM-5 criterion.

NCT ID: NCT04505696 Completed - Clinical trials for Head and Neck Cancer

Providing Speech Therapy Awareness in Private Schools

Start date: August 5, 2020
Phase: N/A
Study type: Interventional

There has been limited research in the area of speech and language therapy awareness in Pakistan. The study aims to assess the efficacy of providing speech therapy awareness in private schools through a pre-post model. This Quasi experimental study will be a means of reaching out to schools and directly create awareness regarding the field and its scope. Pre-assessment will be carried out and after which a 45 minutes presentation will be conducted face to face or through a webinar as per school directives. The results will be analysed quantitatively and pre-post assessment of the participants will be measured.

NCT ID: NCT04496934 Completed - Clinical trials for Substance Use Disorders

Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

Start date: January 30, 2018
Phase: N/A
Study type: Interventional

In terms of research, it is documented that exercise has a positive effect on mental disorders. Studies have shown positive correlations between physical and mental health, also among substance users. Such a study has never been performed on patients in opioid substitution therapy (OST). Documentation on the physical health of patients and the effect of exercise is very limited. Treatment of substance users is a research area with insufficient knowledge about certain treatment effects. It is important that a treatment can both support and promote the user's own resources and efforts to change their habits of substance use. The objective of this project is to examine the effect of exercise for OST patients, measured in relation to cognitive function and physical form. The target group consists of OST patients from 18 years of age and up, of both sexes, and on stable medication. At least 60 participants should complete the project, which is designed as a controlled randomized study (RCT). Participants in the intervention group start to exercise immediately after baseline testing. Participants in the control group are on a waiting list and will start to exercise after twelve weeks. Both groups undergo testing at baseline, after three, six and 12 months. Testing consists of two parts: A battery of cognitive and psychosocial assessments and an assessment of physical variables. The research questions of this project are important in a public health perspective. Generated knowledge can be quickly applied to local treatment institutions in Norway.

NCT ID: NCT04494230 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities

Start date: October 1, 2018
Phase:
Study type: Observational [Patient Registry]

In this study, aged 6-10 years, male, right hand dominant, diagnosed with ADHD, accepting to take part in the study and applying to the Child and Adolescent Psychiatry Department between October 1, 2018 - October 1, 2019 were included in the research group.As for the control group, boys between 6-10 years of age with no mental symptoms described by their teachers or parents and showing healthy development were selected by convenience sampling method and snow ball method. Height and weight measurements of all the children participated in the study were performed. The sociodemographic data form prepared by the researchers was completed by both the research and the control group families. In the sample, the Corners' Parent Scale- Revised Short Form (CPS-R:SF) was used to evaluate the severity of ADHD symptoms.The hand preferences of all participants in the research and control groups were evaluated with Edinburgh Handedness Inventory.Motor skills were evaluated with the 2nd Version of Bruininsky-Oseretsky Motor Competence Test (BOT-2).Hand skills were evaluated with the 9-Hole Peg Test.Visual perception skills were evaluated with 3rd Version of Visual Perception Test without Motor Ability (MVPT-3). Pediatric Quality of Life Inventory Parent Form were filled by the parents of children in the research and control groups for quality of life. In the study, there are five groups: ADHD, ADHD + Specific learning disorders, ADHD + Oppositional defiant disorder, ADHD + Anxiety Disorder and children with typical development group.

NCT ID: NCT04478045 Completed - Emergencies Clinical Trials

The Application of Point-of-care Ultrasonography in Differential Diagnosis of Shock in Emergency and Critical Care

Start date: August 1, 2020
Phase:
Study type: Observational

For the emergency physicians and critical care specialists, how to quickly recognize shock from diverse clinical features and immediately treat shock patients to prevent progression to irreversible organ dysfunction from initially reversible shock condition are important issues and challenges. In recent years, ultrasonography had been extensively used in clinical practice recently, and well-trained medical staffs can quickly and easily apply ultrasound to evaluate, examine, diagnose, and even treat the patients. The clinical application of point-of-care ultrasound can help the first-line physicians rapidly evaluate and diagnose the main symptoms and signs of the patients at bedside, and further initially stabilize and appropriately treat the patients subsequently. The aim of this program is to prospectively collection of the findings of point-of-care ultrasonography in shock patients at emergency room in NTUH. The clinical manifestations, and followed up the examinations, treatments, and prognosis will also be collected. The effect of bedside ultrasound on differential diagnosis and treatment of shock patients will be analyzed. The results of the current study can provide the base for further clinical trials and set up of shock team.