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NCT ID: NCT06423690 Not yet recruiting - Lung Cancer Clinical Trials

First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System

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

A Prospective, open label, multi center, single arm, First in Human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumor resection

NCT ID: NCT06422936 Recruiting - Clinical trials for Basal Cell Carcinoma

Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC)

SPOTLIGHT204
Start date: May 27, 2024
Phase: Phase 2
Study type: Interventional

This is a multicenter, phase 2b, open-label, non-randomized, clinical trial to evaluate safety, tolerability, pharmacodynamics and preliminary efficacy of intra-lesional BO-112 in patients with resectable primary low and high risk basal cell carcinoma. - primary endpoint is complete visual and pathological response [at surgery] on patient level assessed by central review - secondary endpoints are 1. Occurrence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death on patient level. 2. Pathological response [at surgery] on patient level assessed by the investigator and central review, respectively, and visual response [during the study and at surgery] on patient level assessed by the investigator and central review, respectively. 3. Recurrence [at 12 and 24 months] after surgery on patient level assessed by the investigator.

NCT ID: NCT06419881 Completed - Tele-drama Therapy Clinical Trials

Tele-Drama Therapy for Community-Dwelling Older Adults With Constricted Life Space Mobility

Start date: March 3, 2022
Phase: N/A
Study type: Interventional

Older adults with constricted life-space mobility face increased risk of social isolation and poor mental health. Despite the benefits of therapeutic interventions, the literature indicates low use of mental health services in the older population, often due to mobility limitations and/or negative attitudes toward psychotherapy. Developing accessible interventions that address negative attitudes towards mental health services is crucial. Group drama therapy has shown to improve the mental health of older adults, and the creative process itself may help overcome stigmas associated with seeking mental health services. The aim of this study was to explore a 12-week tele-drama therapy group intervention tailored for older adults with constricted mobility. The intervention integrated playback theatre and life review therapy, and was delivered via Uniper Care, an accessible technology designed for older adults. The study will explore the contribution of the intervention and will examine the relationship between processes in drama therapy and their contribution on older adults mental health. This study will also explore the experience of participants, therapists and staff members.

NCT ID: NCT06417827 Recruiting - Clinical trials for Mental Health Diagnosis

Artificial Intelligence for Mental Health Diagnoses and Treatment Plans: A Protocol for Actors and Patients

Start date: December 12, 2023
Phase: N/A
Study type: Interventional

Artificial intelligence (AI) is becoming prevalent in modern medicine and psychiatry. AI is based on a wide variety of computer algorithms classified under machine learning (ML). The purpose of the present study is to evaluate the potential for mental health diagnosis using AI. In the first part of the study, the AI will conduct an interview with standardized patients [SP] (actors) presenting a psychiatric illness. The AI will present a differential diagnosis and treatment plan. Immediately afterward, the actors will be interviewed by a board-certified psychiatrist, who will also give a differential diagnosis and a treatment plan. The results of the AI and psychiatrist will be compared. In the second part of the study, AI will examine patients coming for consultation by a psychiatrist in the inpatient units, outpatient units, or in the emergency room (ER) at Sheba Medical center. The AI results will be compered to the psychiatrist diagnosis.

NCT ID: NCT06416475 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

The Effect of Mankai on Glycemic Control Among Patients With T2D

Start date: April 30, 2024
Phase: Phase 2
Study type: Interventional

The investigators aim to explore the effect of daily supplementation of Wolfia globosa Mankai on HbA1c and insulin resistance response among participants with type 2 diabetes (T2D). The investigators hypothesize that adding daily Mankai to T2D's healthy nutrition might lower HbA1c and promote glycemic control. Methods: A 3-month pilot RCT among 104 patients with T2D, with two intervention arms consuming comparable bottle volumes of either crude plant Mankai beverage (60ml Mankai) or water (60ml) 3 times/day postprandially over 3 months. Blood, urine, fecal, and clinical measures will be taken at 0 and 3 months. Overall appetite, food intake, symptoms, and medical treatment will be monitored. Importance: This study's results will shed light on the effects of regular Mankai consumption on HbA1c among patients with T2D, which may reveal a new nutritional source to improve glycemic control in T2D.

NCT ID: NCT06415344 Not yet recruiting - Angelman Syndrome Clinical Trials

Long-term Extension of GTX-102 in Angelman Syndrome

Start date: August 2024
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety profile of GTX-102 in participants with Angelman Syndrome (AS)

NCT ID: NCT06410118 Not yet recruiting - Nightmare Clinical Trials

The DreamChanger Intervention in Combination With Imagery Rehearsal Therapy for Children's Nightmares

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

This clinical trial will test the efficacy of parent-delivered DreamChanger Intervention in combination with Imagery Rehearsal Therapy (IRT) for reducing the frequency and severity of nightmares in children aged 3-10. Children will be randoimized to either the combined intervention or to a waitlist control group.The intervention will include providing children with the DreamChanger remote, and providing parents with instructional videos, explaining how to use the device along with the IRT strategy to address nightmares. At baseline, mid-treatment, and post-treatment, parents in both groups will complete questionnaires asking about the child's nightmares, sleep, externalizing and internalizing symptoms, PTSD symptoms, demographic characteristics, and parent sleep and distress. Parents in the intervention group will also be asked to complete questionnaires regarding their compliance and satisfaction with the intervention, as well as a 3-month follow-up assessment.

NCT ID: NCT06408935 Recruiting - Crohn's Disease Clinical Trials

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

REASON
Start date: April 17, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.

NCT ID: NCT06404216 Active, not recruiting - Aging Clinical Trials

Nordic Walking Training Program for Sustaining Independent Walking in Older Adult Evacuees

Start date: May 16, 2024
Phase: N/A
Study type: Interventional

Abstract: The purpose of this pilot study is to examine the effect and feasibility of a Nordic walking group training intervention on the physical and mental health of older adults evacuated from their homes to Haifa. Participants: The study will include 31 participants aged 65 and over who are in stable health and have been cleared by their physician to participate in this NW program. Intervention: The intervention will consist of two 60-minute Nordic walking (NW) sessions per week for two months, 16 sessions in total. Participants will be provided with walking sticks to use during the sessions. The sessions will be led by certified health professionals (PT, RN), assisted by trained undergraduate and graduate physiotherapy students. Outcomes: The primary outcome will be endurance to the walking sessions, and average weekly and monthly number of steps, measured by a smartphone application. Secondary outcomes will include three physical tests: 30-second sit-to-stand test, 4-meter walk test and heel raise test. mental health (PHQ-9 depression scale, GAD-7 anxiety scale, WHOQOL- BREF quality of life scale, PANAS short form positive and negative affect scale), and perceived global effect of the intervention. Design: The study will use a single-group pre-test/post-test design. Participants will be assessed at baseline, after two months of intervention, and at six months follow-up. Data Analysis: Data will be analyzed using descriptive statistics and mixed-effects linear regression models. Significance: This pilot study will provide valuable information on the feasibility and effect of this group NW intervention for older adults evacuated from their homes. The findings will be used to plan and design a larger longitudinal RCT.

NCT ID: NCT06399393 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).