Hod Hasharon

Researchers are evaluating pembrolizumab, an immunotherapy, in children and teens with advanced melanoma, solid tumors, and lymphomas that are advanced, relapsed, or refractory. The study aims to determine if different doses of pembrolizumab can reduce or eliminate these cancers. Enrollment restrictions have been applied over time for certain age groups and tumor types. Participants receive pembrolizumab intravenously at a starting dose of 2 mgkg up to 200 mg every three weeks. Different groups include children with melanoma, solid tumors, relapsed refractory classical Hodgkin lymphoma, MSI-H solid tumors, TMB-H solid tumors, and high-risk resected melanoma. Enrollment for some groups has been closed with protocol amendments. Participants will be monitored for tumor response using established cancer criteria over up to two years. Researchers will assess objective response rates, duration of response, progression-free survival, adverse events, and drug tolerability. Safety and disease status are tracked during and after treatment, with study participation lasting until February 2028.

Researchers are conducting a phase 3, open-label extension study to assess the long-term safety and tolerability of KarXT for treating mania or mania with mixed features in adults with Bipolar-I disorder. The study focuses on evaluating how participants respond to KarXT over an extended period, emphasizing safety measurements such as adverse events and symptom changes. Participants will receive KarXT at specified doses over a treatment period lasting up to 54 weeks. This study includes participants previously involved in related placebo-controlled studies as well as new participants diagnosed with Bipolar-I disorder with manic symptoms. The treatment may be given alongside standard therapeutic doses of lithium, valproate, or lamotrigine as applicable. Throughout the study, participants will undergo regular assessments including monitoring of treatment emergent adverse events, serious adverse events, and psychiatric symptom scales like the Columbia-Suicide Severity Rating Scale, Young Mania Rating Scale, and others. Safety and tolerability will be closely tracked, with evaluations occurring up to week 54. The entire participation may last until the study end date in June 2028, ensuring comprehensive long-term follow-up.

This research aims to evaluate the effectiveness and safety of adding KarXT to current treatment for mania in adults with Bipolar-I Disorder. Participants must be experiencing an acute manic episode, with or without mixed features, and currently taking lithium, valproate, or lamotrigine. The study is a Phase 3, randomized, double-blind, placebo-controlled trial assessing KarXT as an adjunctive therapy. Participants will be randomly assigned to receive either KarXT combined with lithium, valproate, or lamotrigine, or a placebo combined with these mood stabilizers. The study drug or placebo will be administered at specified doses on designated days. The trial focuses on treatment during an acute manic episode with monitoring over several weeks to assess changes in mania symptoms and other clinical outcomes. Participants will be monitored through scheduled visits where researchers will measure changes in mania severity using the Young Mania Rating Scale YMRS and other clinical scales. Safety assessments will include tracking adverse events and evaluating other symptom scales related to bipolar disorder. The total study duration includes treatment and follow-up periods lasting up to seven weeks, during which participants health and responses to the study drug are carefully observed.

Researchers are evaluating the effects of KarXT for treating manic episodes in adults with Bipolar-I disorder. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess KarXTs ability to reduce mania symptoms during a 3-week inpatient treatment period. The study includes participants experiencing acute manic episodes or mania with mixed features who require hospitalization. Participants will receive either KarXT or a placebo with flexible dosing during the 3-week inpatient treatment. Before treatment, psychotropic medications must be washed out within 14 days. The study also includes screening before treatment and a safety follow-up, with the entire study lasting up to seven weeks. During the study, participants will be closely monitored with assessments including the Young Mania Rating Scale YMRS and Clinical Global Impressions-Bipolar CGI-BP to measure symptom changes. Safety evaluations and follow-up visits are part of the process, with researchers focusing on symptom improvement and safety over the study duration.

The research investigates the mental and physical health effects of war-related traumatic events on children, adolescents, and their parents in Israel, focusing on psychotherapy outcomes and dropout rates. It addresses gaps in knowledge about distress following the October 7th, 2023 multi-regional conflict, exploring how parental mental health influences childrens well-being and therapy engagement. The study uses both retrospective and prospective methods to understand these impacts and therapy predictors. The study includes two phases a retrospective analysis of electronic health records from Clalit Health Services covering children and adolescents aged 6-18 who received outpatient psychotherapy between 2015 and 2024, and a prospective study involving ongoing psychotherapy cases at Shalvata Mental Health Centers Crisis Intervention Unit. Data includes demographics, diagnoses, therapy attendance, and therapy outcome measures. The prospective phase assesses pre-treatment and within-treatment factors such as therapeutic alliances, expectations, and symptoms over seven weeks with repeated assessments. Participants will undergo various assessments including psychological symptom checklists, somatic symptom scales, and therapeutic alliance questionnaires completed by patients, caregivers, and therapists at baseline and during therapy. Retrospective data will analyze dropout rates and mental health trends before and after therapy. The study will monitor health services utilization up to two years post-therapy start. Consent procedures accommodate parental involvement, and safety protocols address participant distress. Overall participation duration varies by phase and therapy course.

Researchers are studying the relationship between psychotherapy expectations and psychological distress among adults receiving mental health care in psychiatric departments or community clinics, along with their therapists. This observational study takes place at Shalvata Mental Health Center and aims to understand how patients and therapists expectations relate to treatment outcomes over time. Participants include patients treated in closed and open hospitalization units and ambulatory clinics, as well as their therapists. Data collection occurs at four time points baseline, two weeks, four weeks, and eight weeks or at discharge. Questionnaires are completed using the Qualtrics platform, with research staff assisting hospitalized patients and face-to-face interactions at community clinics for initial assessments. During the study, patients and therapists complete multiple scales measuring symptoms, expectations, and clinical impressions. Patients fill out questionnaires at baseline and follow-up points, while therapists also provide input. Suicidal thoughts reported during face-to-face sessions trigger immediate notification to therapeutic staff. The study monitors symptom changes and treatment expectations over an eight-week period or until discharge.

Researchers are investigating how immune-inflammatory biomarkers interact with the oxytocin system to influence the development of posttraumatic stress disorder PTSD and its response to psychotherapy. This observational study includes adults with PTSD symptoms and aims to understand biological factors that may affect treatment resistance and recovery. The study is sponsored by Shalvata Mental Health Center and focuses on trauma-related distress and psychotherapy outcomes. Participants will undergo weekly psychotherapy sessions for 12 weeks, with scheduled assessments of oxytocin and inflammatory markers such as IL-1b2, IL-6, and TNF-b1 in saliva before and after sessions 1, 6, and 12. Self-report questionnaires measuring PTSD symptoms, depression severity, and general anxiety will be completed after these sessions. The study also evaluates psychological resilience and the working alliance between patient and therapist. Throughout the study, participants will provide saliva samples and complete surveys to monitor changes in biological markers and mental health symptoms. Researchers will measure the relationship between these biomarkers and treatment progress over the 12 to 16 week period depending on treatment duration. The study aims to provide insights into factors influencing psychotherapy responsiveness, with ongoing safety and symptom monitoring.