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NCT ID: NCT05340608 Completed - Clinical trials for Autism Spectrum Disorder

Development and Validation of a System for the Anticipation of Challenging Behaviors

Start date: June 1, 2022
Phase:
Study type: Observational

Most people with autism spectrum disorder (ASD) present at least one form of challenging behavior (CB). Self-injurious, aggressive, and disruptive CBs linked with social interaction, community-based service exclusion, and a life quality reduction for people with ASD, their caregivers, and health professionals. The current study has three objectives: 1) to assess the differences in the physiological reaction of high-functioning adults with ASD and typically developed peers, using bio-signal measurements such as heart rate derived from wearable Smart Shirt (SS), 2) to learn which physiological parameters can best predict the imminent onset of a CB, and 3) to develop a system able to predict the incoming occurrence of a CB in real-time and inform the caregiver through an alert notification sent on a smartphone application. Methods and analysis: comparison between physiological parameters will carry out with two groups of 20 participants with and without ASD. Each participant will be asked to watch two five-minute videos while wearing the SS: one showing relaxing images and the other impressive human body deformities. To identify the matching between the physiological parameters variation collected by the SS and the CBs, ten participants with ASD and aggressive or disruptive CBs will be recruited. Each of these participants will wear the SS for seven consecutive days during waking hours, performing their usual daily activities. During the same seven days, the caregivers who care for the participant will fill a behavioral diary with the participant's status, reporting the times of the day in which he is quiet, agitated and the occurrence of CBs. A learning algorithm capable of predicting immediate CBs occurrence based on physiological parameter variations will be developed together with an ad hoc smartphone application. If the algorithm detects the possibility of an incoming CB, a notification will be sent to the caregiver's smartphone to inform of the possible advent of a CB, therefore enabling the implementation of the selected intervention strategy. After developing the algorithm and related smartphone application, a system efficiency proof of concept (POC) will be carried out with one participant with ASD and CB for seven days in a special school setting with healthcare professionals and teachers. A focus group including health professionals will be conducted after the POC to identify the strengths and weaknesses of the developed system.

NCT ID: NCT05336734 Completed - Test Anxiety Clinical Trials

Inter-Brain Synchrony in Psychotherapy for Test Anxiety

IBSP-TA
Start date: May 23, 2021
Phase: N/A
Study type: Interventional

The study aims to examine inter-brain synchrony between patients and therapists over the course of psychotherapy. Eight patients underwent a 6-session course of psychotherapy for test anxiety including Cognitive Behavioral Therapy (CBT) and imagery work, following an existing protocol (see Prinz et al., 2019), as well as a pre- and post- treatment interview (with different interviewers). The researchers used functional near-infrared spectroscopy (fNIRS) imaging to record brain activity during both interviews and sessions 1, 3, and 5, and collected saliva samples to measure hormone levels during the same sessions. Participants completed questionnaires before and after the study, and before and after each session. The researchers hypothesized that synchrony will gradually increase over the psychotherapy sessions, that synchrony in the pre-treatment interview will be lower than in the post-treatment interview, and that synchrony would be correlated with increases in Oxytocin.

NCT ID: NCT05335005 Completed - Clinical trials for Kidney Failure, Chronic

MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)

Start date: May 30, 2022
Phase: Phase 1
Study type: Interventional

MK-2060 is being developed for prevention of thrombotic complications in end-stage renal disease (ESRD). The purpose of this study is to conduct a preliminary evaluation of the safety and tolerability of MK-2060 treatment in combination with a commonly used P2Y12 receptor inhibitor, clopidogrel, in ESRD patients.

NCT ID: NCT05332847 Completed - Clinical trials for POCUS Assessment During Ambulatory PAH Clinic

Point of Care Ultrasonography Assessment During Pulmonary Hypertension Clinic

POCUSPAH
Start date: January 14, 2018
Phase: N/A
Study type: Interventional

Background: Changes occurring in the pulmonary vascularity imparts changes to the right heart in patients with pulmonary arterial hypertension (PAH). Importantly changes in RV function correlates with severity of disease and patient outcome. This affords and opportunity to assess patients longitudinally through point of care ultrasonography. Investigators objective was to measure the percentage and the rate of patients management change, represented by change in treatment or assessment of patients in the PAH clinic, and to compared management change rate between patients with PAH who underwent point of care ultrasonography (POCUS) assessment in addition to the routine evaluation, and a control group to which the investigators did not add a test with POCUS in addition to the routine evaluation in the clinic. Methods: Consecutive patients from the PAH clinic in two medical centers were randomized to the POCUS assessment group and the non-POCUS group. The POCUS group received lung, heart, and vascular ultrasound assessments. All other assessments were the same between both groups. Management changes were documented during each of the patients' visits over a three-month interval.

NCT ID: NCT05308680 Completed - COVID-19 Clinical Trials

Myocardial Injury After BNT162b2 mRNA COVID-19 Fourth Dose Vaccination Among Israeli Health Care Workers

Start date: January 6, 2022
Phase:
Study type: Observational

The aim of the study is to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.

NCT ID: NCT05308186 Completed - Clinical trials for Disorder of Consciousness

Effectiveness of Sensory Stimulation on Attenuating Pain and Stress Among Patients With Disorders of Consciousness

Start date: April 10, 2022
Phase: N/A
Study type: Interventional

The aim of the presented study is to examine the effectiveness of sensory stimulation in reducing pain and stress of patients diagnosed with Disorder of consciousness.

NCT ID: NCT05276323 Completed - Atopic Dermatitis Clinical Trials

Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study

Start date: October 1, 2020
Phase: Phase 2
Study type: Interventional

A randomized, open-label trial comparing Medihoney Derma Cream to Hydrocortisone 1% cream. Children between the ages of 2-18 years old diagnosed with mild to moderate atopic dermatitis with an IGA (Investigator Global Assessment) score of 2-3, and a BSA (Body Surface Area) score of 1%-10% were included.

NCT ID: NCT05275556 Completed - Colon Polyp Clinical Trials

Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)

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

This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. The control arm is colonoscopy performed with High Definition White Light Endoscopy (HD-WLE) per standard of care. The intervention arm is colonoscopy performed with HD-WLE per standard of care plus the Computer-Assisted Detection (CADe) Device.

NCT ID: NCT05270226 Completed - ADHD Clinical Trials

Metacognitive ADHD Telehealth Intervention for Work-performance Enhancement (Work-MATE)

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

Adults with Attention-deficit hyperactivity disorder (ADHD) experience poor occupational performance at work compare to adults without ADHD, manifested at tendencies toward unemployment, job instability, work accidents, and sickness absences. This poor occupational performance at work may be partly caused by difficulties at executive functions (EF) abilities, and at the ability to set and attain goal directed work-activities at a satisfactory manner. Therefore, improvement at those abilities may followed by occupational performance at work enhancement of adults with ADHD. Such improvement may enhance adults with ADHD quality of life. Despite the wide-ranging implications of poor occupational performance at work of adults with ADHD, treatments which focus at this component improvement among adults with ADHD are lack. The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) is an innovative program that aim to improve occupational performance at work of adults with ADHD, by enhancing their EF abilities, self-awareness, and personal strategy use. This program was established based on existing fundamental models and approach, (1) The World Health Organization's international classification of functioning, disability and health (ICF) (WHO, 2001), (2) Person-Environment-Occupation-Performance model (Baum, Christiansen, & Bass-Haugen, 2015) (3) The Dynamic Interactional Model of cognition (DIM; Toglia, 2018) and the Multicontex approach (Toglia, 2018) which based on the it, and (4) Telehealth as service-delivering model. The Work-MATE aim to promote self-awareness and self-generation of personal strategies and increase efficiency strategy use across meaningful purposeful everyday work activities (i.e., goal directed work-activities). It is a short, synchronous and hybrid teleintervention program of eleven 1-hour weekly individual sessions, focused directly on occupational performance at work enhancement of adults with ADHD.

NCT ID: NCT05259917 Completed - Clinical trials for Hereditary Angioedema

A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Start date: February 23, 2022
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients