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NCT ID: NCT05923944 Not yet recruiting - Anxiety Clinical Trials

Video Game Play to Alleviate Adolescent Anxiety

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

Adolescence is a critical period for the onset and maintenance of anxiety disorders, which raises the importance of intervening early; one possibility of doing so is via digital interventions. At least two lines of research have been explored in the past years in this area. First, studies have tested the anxiolytic effects of casual video games, hypothesizing that, through the induction of flow, these games can effectively distract individuals from anxiety-related thoughts and feelings. Second, the bidirectional link between poor attentional control and higher anxiety has led to the design of novel interventions aiming to improve attentional control such as working memory training studies. Importantly, action video games, classified as a distinct gaming genre, have been shown to enhance attentional control. In this study, we aim to compare the effects of action video game play and casual game play to a no-training group, assessing their potential to alleviate anxiety when delivered entirely online. The goal of this three- arms randomized controlled trial is to evaluate the feasibility of a 6-week video game training intervention to reduce adolescent anxiety-related symptoms. We will also examine the efficacy of the proposed treatment when entirely deployed at adolescents' home.

NCT ID: NCT05919849 Not yet recruiting - Clinical trials for Parent-Child Relations

Supporting Parents in Affirming Their Children's Experiences of Stigma

SPACES
Start date: April 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and test two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States.

NCT ID: NCT05865288 Not yet recruiting - Eating Disorders Clinical Trials

The Moderating Role of Baseline Oxytocin on Its Psychotherapy-facilitating Effects Among Patients With Eating Disorders

Start date: June 30, 2023
Phase: Phase 1
Study type: Interventional

Introduction: Oxytocin (OT) is a nine-amino acid neuropeptide known to play a vital part in social behaviors and has also been found to be involved the social manifestations of mental illnesses, such as social manifestations and social cognition. it has been suggested that OT administration may serve as an add-on treatment for individuals with mental illnesses. One group of patients affected by social are patients with eating disorders (EDs). Studies of OT administration among individuals with EDs have shown an inconsistent pattern of findings, which might be associated with the differential baseline level of OT dysregulation. Thus OT dosing needs to be optimized, while considering patients baseline OT levels prior to administration. Patients with ED are also known to have lower OT levels at baseline. It is possible that OT's administration will affect interpersonal behavior through the increase of lowered OT levels, thus leading to overall improvement of ED symptoms. This study aims to examine the effects of OT administration among patients with EDs, while focusing on baseline OT levels and interpersonal abilities as potential moderators and/or mediators of its effects. The research addresses the following questions: (1) is OT administration associated with increased therapeutic gains among patients with ED? (2) what are the moderators and mediators of these effects, and specifically, do baseline levels of OT and baseline interpersonal abilities moderate these effects? (3) what is the mechanism underlying OT's therapeutic effects, and specifically do changes in interpersonal abilities and changes in OT levels serve a mediating role? Methods: This study aims to assess the differential effect of OT administration among patients with varying levels of baseline saliva OT and to explore the effects of optimizing frequency and dosage of administration of OT, based on baseline characteristics. Participants: Female and male Individuals (N=90) with verified diagnosis of EDs, age 16 and above, will participate in at least four weeks of treatment at the EDs unit. Subjects will be recruited at the Teradion Eating Disorder Clinic, an outpatient unit in North Israel. Procedure: Patients and caregivers will sign an informed consent form. Baseline saliva OT will be measured four times during consecutive days. At week 1 patients will be assessed for general distress, ED symptoms, cognitive rigidity, interpersonal abilities, as well as patients and therapists reported working alliance. At week 2 patients will be randomized at a ratio of 2:1 with 60 patients receiving OT and 30 receiving placebo. Patients will receive 24 IU of OT or placebo, once a week, prior to therapy sessions, for a period of 4 weeks. During these weeks (2-5), they will be assessed for levels of OT, general distress, interpersonal abilities, working alliance and cognitive rigidity. All measurements will be performed finally at week 6. Novelty: This study is the first to assess the effectiveness of OT as an add-on for patients with EDs, during clinical treatment, as well as to explore modulators such as baseline OT levels, and mediators such as social abilities and cognitive rigidity, on the overall improvement of ED patients in therapy.

NCT ID: NCT05807997 Not yet recruiting - Clinical trials for Refusal of ICU Admission

Patients Who Were Not Admitted to the Intensive Care Unit: Characteristics and Clinical Outcomes. Retrospective Study

Start date: August 1, 2024
Phase:
Study type: Observational

There is extensive medical literature supporting the contribution of intensive care physicians to improvement of clinical outcomes in patients treated in an intensive care unit (1-3). There are many reasons for this contribution, including adherence to evidence-based medical protocols, as well as collaboration between different medical specialties in patient care (4-7). Over the years, several criteria have been formulated for the admission of patients to intensive care (8) according to their medical condition, but there are other factors that influence the decision whether to admit patients to intensive care, not necessarily medical ones, such as the availability of beds in the unit and the availability of medical and nursing staff. There are several studies that examined the characteristics and clinical outcomes of patients who were not admitted to the intensive care unit, for medical or paramedical reasons (9). We would like to retrospectively examine all patients in the last 5 years who were presented for admission to general intensive care from various departments in our institution but were not admitted, to characterize the reasons why they were not admitted, the clinical characteristics of the patients and their clinical outcomes. Objectives: Main objective: To characterize the clinical outcomes of the patients who were presented for admission to general intensive care but were not admitted in the last 5 years. Secondary objectives: To characterize the reasons why the patients were not admitted - medical and paramedical, and to examine the clinical characteristics of these patients (age, sex, background diseases and current disease.). Design and methods: Study design: This is a retrospective study based on data collection. Methods and materials: Collecting information from computer systems regarding the patients who were presented by the various departments at the Meir Hospital in Kfar Saba for admission to the general intensive care unit and were not admitted, starting from the beginning of January 2018 until the beginning of January 2023. These are about 1000 patients. After the end of data collection in the study, the data will be typed anonymously into a dedicated Excel file. The patients will be identified according to the patient number in the study and the case number, without specifying identifying details. Inclusion criteria: All patients aged 18--99 who were presented to the general intensive care unit from January 2018 to the end of December 2023 and were not admitted. Data collection: The research will be conducted in the format of observational data collection from the patient files and from computerized systems (Camelion system and iMDsoft software). The data collected in the study will be exposed to the research team only as long as the actual data collection is carried out. After the end of data collection in the study, the data will be typed anonymously into a dedicated Excel file. The patients will be identified according to the patient number in the study and the case number, without specifying identifying details. The data to be collected: age, sex, underlying diseases, regular medications, duration of hospitalization, need for ventilation, number of days of ventilation, mortality within 28 days, APACHE-2 score, SOFA score, lactate level, need for pressors, need for dialysis or other RRT, The reasons for not being admitted to the intensive care unit. Size of the research group: about 1000 patients - this is the estimated number of patients in the time period detailed above. The method of processing the results: all the demographic and in-hospital indicators will be tested statistically by a certified statistician depending on the type of data.

NCT ID: NCT05784350 Not yet recruiting - Clinical trials for Intra-operative Hypotension

Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension

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

Hypotension is a common side-effect of general anesthesia induction and is related to adverse outcomes including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury.Half of all the patients were fluid-responsive, pointing to volume status as a significant risk factor. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration, including the maximal diameter of the IVC (dIVCmax) at the end of expiration during spontaneous respiration and the collapsibility index (CI), have been recommended as rapid and noninvasive methods for estimating volume status. In attempt to prevent hypotension after spinal anesthesia induction, Ondansetron, a serotonin receptor antagonist, has been used effectively . Research Question Can preoperative IVC-US guided fluid optimization and intravenous ondansetron reduce the incidence of general anesthesia-induced hypotension in adult patients undergoing elective non-cardiac non-obstetric surgery?

NCT ID: NCT05727241 Not yet recruiting - Clinical trials for Intrauterine Growth Restriction

Three-dimensional Umbilical Cord Coiling Index

Start date: July 1, 2023
Phase:
Study type: Observational

Previous studies have shown that abnormal coiling of the umbilical cord is associated with adverse perinatal outcome. For example, an umbilical cord that is non-coiled increases the chance of fetal morbidity and mortality, moreover, they have shown that the lack of the usual coiled umbilical cord configuration may result in an umbilical cord that is structurally less able to withstand external mechanical stress, on the other hand, studies from recent years show that hypercoiling - excessive coiling of the umbilical cord is associated with poor obstetric outcomes, such as fetal distress at birth, meconium staining, fetal acidosis, premature birth, intrauterine growth disorder and even fetal death. The studies carried out on the calculation of UCI include performing these measurements in two dimensions, including Doppler activation, but no studies were carried out in which three dimensions were used. The purpose of the study is to measure UCI using a 3D method in a random sample of 250 patients beyond 24 week of gestation, and to compare pregnancies with hypercoiling, hypocoiling or with a normal number of coils in terms of birth outcomes.

NCT ID: NCT05718739 Not yet recruiting - Parkinson Disease Clinical Trials

Assessing and Understanding Freezing of Gait at Home: FOG@Home

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

Freezing of gait, (FOG) is an unpredictable, abrupt, short phenomenon that severely affects Parkinson's disease (PD) patients' gait and quality of life. The common measure tools are self-questioners that present the subjective feelings and the FOG provoking tests that used in clinic for evoking FOG and getting the estimated duration and the phenotype of the expressed phenomenon. The objective of this study is to investigate the FOG phenomenon using video cameras at patients' home with combination of wearable-axivity sensors and smart soles with a goal of objective assessment and quantification of freezing of gait severity in unsupervised daily-living environment of the PD patients.

NCT ID: NCT05698264 Not yet recruiting - Clinical trials for Non Small Cell Lung Cancer

A Pilot Study to Understand the Impact of Therapy With Tumour Treating Fields (TTFields) in NSCLC

Start date: January 20, 2023
Phase: N/A
Study type: Interventional

Low intensity, intermediate frequency (100-300 kHz) alternating electric fields, also known as Tumor Treating Fields (TTFields) were found to have a profound inhibitory effect on the growth rate of a variety of human cancer cells. Previous study showed anti-tumor activity in respect of melanoma, glioblastoma (GBM), breast carcinoma and NSCLC cell lines. This study aims to assess the impact of TTFields on NSCLC though the understanding of tumor evolution and peripheral lymphocytes activity and proliferation. Concomitant to drug therapy, patients will receive treatment with Tumor Treating Fields (TTFields), generated by the medical device NovoTTF-200T with a recommended duration of minimum 18 h a day. TTFields administered using insulated transducer arrays applied to the skin surrounding the region of a malignant tumor. 50 patients will be recruited according to the study design in two cohorts and will receive TTFields therapy: Cohort A: Adult NSCLC EGFR positive mutation. Cohort B: Adult NSCLC patients to be treated with PD-1 inhibitors. The cohort A will focus on the clonal evolution in EGFR mutated lung cancer patients by using circulating tumor DNA (ctDNA) analysis of paired baseline and end-of-treatment (EOT) plasma samples. The cohort B will study the impact of TTField on the profile, activity, and proliferation of peripheral lymphocytes. Lymphocytes will be purified from whole blood samples for the profile, proliferation, and activity analyzed by FACS. Treatment with TTFields will be administered until progressive disease, unacceptable toxicity1, withdrawal of consent or death. After the end of treatment, the patients will be followed until data cutoff date or 2 years after the last patient had entered the study.

NCT ID: NCT05687942 Not yet recruiting - Surgical Incision Clinical Trials

The REBUILD Trial: Closure of the Abdominal Wall

Start date: March 2023
Phase: N/A
Study type: Interventional

The main objective of this clinical trial is to demonstrate the safety and efficacy of REBUILD when used to support abdominal wall closure after laparotomy. The main question it aims to answer are whether the device when used to support suture in abdominal wall closure safely maintains apposition of the abdominis rectus muscles within a pre-defined distance. Participants will undergo standard of care laparotomy and the investigational device will be used to support the suture used to close the abdominal wall. Participants will have an MRI at 1-month after surgery to measure the distance between the abdominus rectus muscles.

NCT ID: NCT05622539 Not yet recruiting - Acute Stroke Clinical Trials

Validate: Trustworthy AI to Improve Acute Stroke Outcomes

VALIDATE
Start date: November 2023
Phase:
Study type: Observational

Artificial intelligence (AI)-powered prognostic tools and clinical decision support systems can predict the outcome of certain diseases based on a multitude of patient data at high speed, facilitating decisions by healthcare professionals. In acute ischemic stroke, the overall treatment effect and population-wide outcome benefit of treatments such as IV thrombolysis and mechanical thrombectomy are well established. However, in individual patients it is difficult to predict the prognosis in the acute phase of stroke: some patients are candidates for these treatments, but may have poor clinical outcomes (no improvement of stroke or even worsening) Our aim in this study is to validate an artificial intelligence (AI)-based prognostic tool to provide accurate real-time outcome prediction in patients with acute ischemic stroke. During the study, all patients admitted to the emergency room with an acute ischemic stroke will receive the usual treatment for acute stroke in accordance with the stroke neurologists in charge. A "shadow" clinical researcher, without interaction with treating physicians, will collect the data required by the AI model in vivo. These data will be obtained by filling in clinical data through an App on a hospital mobile/tablet, and by a connection with your electronic medical record. The AI models will estimate the outcome of the acute stroke patient, and this prediction will be compared with the real outcome of the patient after 3 months of follow-up.