Examining the Effectiveness of Family and Community-Based Intervention Programs to Improve Treatment Adherence for Overweight, Obesity, Prediabetes, Metabolic Syndrome, and Type 2 Diabetes in the Bedouin Community in the Negev

Background:
The Bedouin community in the Negev faces high rates of type 2 diabetes, low treatment adherence, and increased disease complications. Transition to urban living and changing dietary patterns have exacerbated these issues. Current interventions often overlook the potential of culturally tailored approaches leveraging kinship ties and community resources. This study seeks to address these gaps by examining the impact of a family-centered intervention program.
Objectives:
Primary: Assess the effect of community intervention on Mediterranean diet adherence.
Secondary: Evaluate changes in fasting glucose, HbA1c, lipid profiles, BMI, physical activity, and quality of life.
Methodology:
Study Design: Controlled community intervention trial with two groups (intervention and control).
Participants: 170 Bedouin adults diagnosed with overweight, obesity, metabolic syndrome, prediabetes, or type 2 diabetes.
Intervention: 10 sessions over 12 months focusing on nutrition, physical activity, and behavioral changes, tailored to cultural norms.
Control: Routine care without added intervention. Outcome Measures: Lab tests (HbA1c, lipid profiles), anthropometric measures, Mediterranean diet adherence, physical activity, quality of life, and social belonging.
Recruitment and Data Collection:
Participants will be recruited via Clalit clinics in Rahat, with the support of local community leaders. Data will be collected through medical records, questionnaires, and physical assessments at baseline, 6, and 12 months.
Data Analysis:
Statistical analysis will be performed using SAS/SPSS, employing ANOVA, Chi-square tests, and regression models for outcome prediction.
Ethical Considerations:
Participants' privacy will be ensured through coded data storage. The study will comply with Helsinki guidelines, and participants can withdraw at any time.
Conclusion:
This study aims to provide culturally tailored interventions to improve health outcomes in the Bedouin community, potentially serving as a model for similar minority groups globally.

开始日期2024-09-01

申办/合作机构

Ariel University

[+1]

NCT06416267

/ Not yet recruitingN/AIIT

Immune Biomarkers, Genetic Risk, and the Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)

The aim of this proposal is to identify immune biomarkers, genetic risk, and the clinical consequences of low count monoclonal B-cell lymphocytosis (LC MBL), a common premalignant condition affecting up to 17% of European adults age>40. LC MBL is a precursor to chronic lymphocytic leukemia (CLL), characterized by a circulating population of clonal B-cells. It is relatively understudied, despite emerging evidence of clinical consequences such as increased risk for life-threatening infections and lymphoid malignancies. Studies reported that male sex, age, family history of CLL, and CLL-susceptibility genetic loci were associated with LC MBL risk. These findings were reported in European ancestry individuals and have not been generalized to other thnicities. This study will provide this missing knowledge using a unique multi-ethnic Israeli population of Jews and Arabs that have one of the highest and lowest age-standardized incidence rates of CLL in the world, respectively, and characterized with different genetic backgrounds.

开始日期2024-08-01

申办/合作机构

University of Haifa

[+2]

NCT06332066

/ Not yet recruiting临床1期IIT

Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness

In recent years there is a great interest in the possible role of Oxytocin (OT) as a facilitator for enhancing psychotherapeutic processes in patients with mental illnesses. Specific studies explored OT administration to patients, and the effect on psychotherapy on interaction within the therapeutic dyad. Nonetheless, studies exploring OT's effects of the therapists' side of the therapeutic dyad on the psychotherapy session and outcome, have not been conducted. The current study aims to assess the effect of OT administration to the therapists of psychiatric outpatients, on treatment process and outcome and specifically on the patient and therapist experience of the attunement and responsiveness toward the patient in the therapeutic encounter. Twenty staff members from Teradion Mental health Clinic of Clalit Health Services will be recruited, as well as 100 patients treated by these staff members. Therapists agreeing to participate will receive OT and PLC in a random order, at the same day they are seeing the same patients and the consecutive week. Patients agreeing to participate will complete a demographic questionnaire and all study measures, and will be scheduled to perform two consecutive research sessions with their therapists. The therapist will receive either OT or PLC in each of these two sessions, and right after the session the patients will complete the assessment scales. Multilevel models will be performed by the investigators to assess the effects of OT administration in therapists receiving OT versus receiving placebo. This research will be performed in accordance with ethical principles of Helsinki WMA Declaration. This study is the first to assess the effectiveness of hormonal augmentation for therapists and its influence on therapeutic process with patients suffering from acute distress in the public mental health domain.

开始日期2024-05-01

申办/合作机构

Shalvata Mental Health Center

[+1]

100 项与 Clalit Health Services 相关的临床结果

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0 项与 Clalit Health Services 相关的专利（医药）

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2,542

项与 Clalit Health Services 相关的文献（医药）

2025-12-31·The Journal of Maternal-Fetal & Neonatal Medicine

Angle of progression for predicting second-stage cesarean delivery complications

Article

作者: Matot, Ran ; Shmueli, Anat ; Daniel, Sharon ; Charach, Ron ; Sigal-Kaplun, Sharon ; Geron, Yossi ; Romano, Asaf ; Gilboa, Yinon

OBJECTIVETo investigate the correlation between the angle of progression (AOP) and maternal surgical complications following a second-stage cesarean delivery.METHODSWe retrospectively evaluated singleton pregnancies at term (≥37 weeks) who underwent cesarean delivery for arrest of descent at the second stage of labor from January 2022 to December 2023. Only cases with recorded AOP were included. The fetal head position was confirmed by transabdominal ultrasound, and the fetal head station was assessed manually by digital examination. The main outcome was defined as a composite adverse maternal outcome, including challenging fetal extraction, uterine extension, requirement for blood transfusions, postpartum fever, ileus, and re-hospitalization due to endometritis or surgical site infection.RESULTSTwenty-five cases met the inclusion criteria, of whom 10 (40%) experienced the composite adverse maternal outcome. These patients had wider mean AOP compared to those without maternal morbidity (136.7 ± 7.4 vs. 124.7 ± 12.5, p = .017). Univariate logistic regression analysis showed a significant correlation between measured AOP and composite adverse maternal outcome (OR = 1.15, 95% CI 1.01-1.30, p = .028). The predicted probability for composite adverse maternal outcome by receiver-operating characteristics curve yielded an area under the curve of 0.79 (95% CI 0.60-0.98) for AOP, compared to an area under the curve of 0.53 (95% CI 0.30-0.75) for the manually measured fetal head station.CONCLUSIONSWe found a correlation between the angle of progression and maternal complications following second-stage cesarean delivery. Assessing the angle of progression before surgery may be of help to the obstetrical team to better identify susceptible cases and allow for appropriate preparation.

2025-08-01·Seminars in Arthritis and Rheumatism

Biologic switching in psoriatic arthritis: Insights from real-world data and key risk factors

Article

作者: Feldhamer, Ilan ; Haddad, Amir ; Saliba, Walid ; Stein, Nili ; Zisman, Devy ; Cohen, Arnon Dov

BACKGROUNDPsoriatic arthritis (PsA) is a chronic, heterogeneous inflammatory condition requiring personalized treatment strategies. Biologic therapy switching reflects the disease's dynamic nature and aims to optimize disease control while balancing efficacy, safety, and patient-specific factors.OBJECTIVETo analyze real-world switching patterns of biologic disease-modifying antirheumatic drugs (bDMARDs) in PsA patients, identify associated risk factors, and provide insights into predictors of mode-of-action switching.METHODSThis retrospective cohort study utilized the Clalit Health Services database (2005-2023), encompassing 9607 PsA patients in Israel. Patients initiating bDMARDs were tracked for therapy switches. Clinical, demographic, and socioeconomic variables were extracted, and statistical analyses compared characteristics between switchers and non-switchers. Patterns of switching were stratified by the number of switches and study periods (2005-2014, 2015-2023).RESULTSAmong 3851 patients initiating bDMARDs, 1848 (48 %) switched therapy at least once. Anti-TNF therapy was the dominant first-line choice, but switching to anti-IL17 therapy became prevalent as the first switch in both single-switch and multi-switch scenarios. Subsequent switches often involved cycling back to anti-TNF or transitioning to other modes of action, such as anti-IL23 or JAK inhibitors. Switching patterns remained consistent across study periods. Switchers were more likely to be female (56.5 vs. 50.6 %, p < 0.001), obese (28.1 vs. 22.6 %, p < 0.001), smokers (41.6 vs. 37.1 %, p = 0.005), and from lower socioeconomic backgrounds (34.1 vs 31.4 %, p = 0.04). These factors were all independently associated with switching in mechanism of action on multivariate analysis.CONCLUSIONCross class biologic switching is common in PsA management (48 %) and influenced by patient demographics and comorbidities. Switching patterns were consistent across time periods despite expanding therapeutic options.

2025-06-01·Computers in Biology and Medicine

A machine learning approach to differentiate stage IV from stage I colorectal cancer

Article

作者: Yousef, Miar ; Yousef, Malik ; Alamor, Walid ; Abu-Freha, Naim ; Afawi, Zaid ; Esbit, Simon ; Sanalla, Noor

BACKGROUND AND AIMThe stage at which Colorectal cancer (CRC) diagnosed is a crucial prognostic factor. Our study proposed a novel approach to aid in the diagnosis of stage IV CRC by utilizing supervised machine learning, analyzing clinical history, and laboratory values, comparing them with those of stage I CRC.METHODSWe conducted a respective study using patients diagnosed with stage I (n = 433) and stage IV CRC (n = 457). We employed supervised machine learning using random forest. The decision tree is used to visualize the model to identify key clinical and laboratory factors that differentiate between stage IV and stage I CRC.RESULTSThe decision tree classifier revealed that symptoms combined with laboratory values were critical predictors of stage IV CRC. Change in bowel habits was predictive for stage IV CRC among 14 of 22 patients (63 %). Weight loss, constipation, and abdominal pain in combination with different levels of carcinoembryonic antigen (CEA) were predictors for stage IV CRC. A CEA level higher than 260 was indicative for stage IV CRC in all observed patients (61 out of 61 patients). Additionally, a lower CEA level, in combination with hemoglobin, white blood cell count, and platelet count, also predicted stage IV CRC.CONCLUSIONSBy applying a machine learning based approach, we identified symptoms and laboratory values (CEA, hemoglobin, white blood cell count, and platelet count), as crucial predictors for stage IV CRC diagnosis. This method holds potential for facilitating the diagnosis of stage IV CRC in clinical practice, even before imaging tests are conducted.

项与 Clalit Health Services 相关的新闻（医药）

2025-02-13

·PRNewswire

Exero Medical closes on $12.7M preferred seed financing and establishes US presence to support clinical and commercial activities

JERSEY CITY, N.J., Feb. 13, 2025 /PRNewswire/ -- Exero Medical, a US and Israel based company focused on early detection of post-operative complications using tissue healing data, has secured up to $12.7M in funding to complete its FDA pivotal trial and launch its breakthrough-designated xBar system in the United States. The round includes $10M in upfront funding and additional milestone-based warrants, as well as $2.7M in non-dilutive grants. This financing includes investments from new investors Longevity Venture Partners, Tech Council Ventures, and Edge Medical Ventures, alongside participation from existing investors. Mortality rates in patients with severe complications after gastrointestinal surgery can be up to 20% due to challenges in identifying these complications early. The xBar system uses sensors placed at the surgical site to collect data that can assist clinicians in early detection of major, life threatening complications after gastrointestinal surgery. Raissa Hacohen, Managing Partner at Longevity Venture Partners, comments, "We were thrilled to lead Exero's latest round as we believe in the potential of innovative medical technology to unlock new health data. We support Exero's vision of creating efficiency within the healthcare system and improving patient outcomes by adding dimensions of new health data into the existing workflow." Mark Kolb, Partner at Tech Council Ventures, adds, "Exero Medical's breakthrough xBar system has the potential to revolutionize post-operative care by providing critical real-time data to detect complications early—ultimately saving lives and reducing healthcare costs. Tech Council Ventures is proud to support Exero's growth and expansion into the U.S. market." Shai Policker, General Partner at Edge Medical Ventures and Chairman of Exero, shares: "We are excited to welcome new investors in support of Exero's clinical program, regulatory clearance, and launch of the xBar system. Additionally, Exero's new US headquarters in Scitech Scity at the Liberty Science Center in Jersey City, NJ, will serve as a vital hub for these important initiatives." About Exero Medical Exero Medical's mission is to empower health care providers with high-quality, actionable post-operative tissue healing data that can save lives, improve prognosis, and reduce cost of care. The company's flagship product, the xBar system, has been granted Breakthrough Device Designation by the FDA. Exero Medical was founded in 2018 by MEDX Xelerator, and is backed by the Israeli Innovation Authority, Tech Council Ventures, Longevity Venture Partners, Edge Medical Ventures, Consensus Business Group (CBG), Unorthodox Ventures, and Clalit Health Services – the largest HMO in Israel. The xBar system is not approved for sale in the United States and is limited to investigational use. Media contact: Eileen Ke Vice President, Business Development (+1) 267-342-0576 [email protected] SOURCE Exero Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-12-18

·PRNewswire

Exero Medical Announces Enrollment of 100th Patient in Pivotal Study to Validate its Breakthrough Technology for Early Detection of Post Operative Complications

OR YEHUDA, Israel, Dec. 18, 2024 /PRNewswire/ -- The study, which includes eleven sites in the US and Israel, is enrolling patients undergoing colorectal resection surgery to validate the safety and accuracy of Exero's xBar system for early detection of major, life-threatening complications such as an anastomotic leaks. The outcome of the study will support Exero's FDA De Novo submission. Continue Reading Exero’s xBar system The xBar system consists of electrode sensors embedded in a standard surgical drain and placed near the anastomosis site. The electrodes are connected to a small electronic device outside the patient's body that records and relays data. The data is analyzed to indicate the risk of anastomotic leaks based on the status of tissue healing or damage. The study commenced in March 2024, and the one hundredth patient was enrolled at Bryan Medical Center in Lincoln, Nebraska, by Dr. Brad Olberding, MD, General Surgeon. Dr. Michael Jobst, Bryan Medical Center's Principal Investigator, explains, "The xBar sensor is placed through the standard procedure for surgical drains, and does not alter our routine surgical and post operative workflow. If proven successful, the data provided by xBar can support us with earlier detection of post operative complications. This could allow surgeons to intervene before the patient's condition becomes dire and help minimize prolonged hospital stays." Dr. Erez Shor, Exero Medical's CEO, said, "This milestone marks significant progress toward the completion of xBar's pivotal trial, and brings us one step closer to making this technology available to circumvent life threatening complications, helping both patients and surgeons." Further information can be found at Clinicaltrials.gov or . About Exero Medical Exero Medical's mission is to empower health care providers with high-quality, actionable post-operative tissue healing data that can save lives, improve prognosis, and reduce cost of care. The company's flagship product, the xBar system, has been granted Breakthrough Device Designation by the FDA. Exero Medical was founded in 2018 by MEDX Xelerator, and is backed by the Israeli Innovation Authority, Longevity Venture Partners, Edge Medical Ventures, Clalit Health Services – the largest HMO in Israel, and Unorthodox Ventures. The xBar system is not approved for sale in the United States and is limited to investigational use. Media contact: Eileen Ke Vice President, Business Development (+1) 267-342-0576 [email protected] SOURCE Exero Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床研究突破性疗法

2024-07-22

·PRNewswire

CannaMore Biotechs Announces Successful Completion of Phase 2a Clinical Trial for Cannabidiol-Based Treatment for Ulcerative Colitis

TEL AVIV, Israel, July 22, 2024 /PRNewswire/ -- CannaMore Biotechs, an Israel-based clinical-stage company focused on Cannabidiol (CBD) based treatments, is pleased to announce the successful completion of its Phase 2a clinical trial evaluating the safety and efficacy of a CBD-based patent protected formulation for patients with Ulcerative Colitis (UC). The trial is an open-label, single-arm study, aimed to assess the safety, tolerability, and efficacy of the CBD-based IP-based enema formulation, IcBD-01, as a potential treatment for UC. Conducted over a three-month period, the study included 10 patients who completed the trial, with promising results observed in the majority of participants. Key highlights from the trial include: Primary Endpoint Achieved: A significant number of patients demonstrated a reduction in Mayo scores, indicating a decrease in disease severity. Patient-Reported Outcomes (PRO): Most participants reported substantial improvements in their symptoms, including reduced abdominal pain and better overall well-being. Safety and Tolerability: The formulation was well-tolerated with no significant side effects observed, confirming the safety profile of IcBD-01. Prof. Timna Naftali, a specialist in gastroenterology at Meir Hospital in Kfar Saba, led the study, which was conducted at the Israeli medical facilities of leading Hospital Meir at Kfar Saba, Israel. Meir Hospital is one of the 14 full-scale hospitals of Clalit Health Services, the 2nd largest HMO in the world and CannaMore's partner through Mor Research Applications TTO. "The results of this trial are highly encouraging and support the potential of IcBD-01 as an effective treatment for Ulcerative Colitis," said Prof. Naftali. "We observed significant improvements in both clinical outcomes and patient-reported symptoms, which marks a promising step forward in our ongoing efforts to develop innovative CBD-based therapies. This treatment may provide a safe and effective solution for the subgroup of patients with ulcerative proctitis, where there is an unmet need for effective and safe treatment." Based on these positive outcomes, CannaMore Biotechs plans to both advance to the next stage of clinical trials to further evaluate the long-term efficacy and safety of IcBD-01, while also exploring more immediate non-drug markets (such as medical Cannabis and others) sales in parallel to the drug R&D aimed for an FDA approval. About CannaMore Biotechs Ltd. CannaMore Biotechs Ltd. is a company dedicated to the simultaneous independent research and development of cannabinoid-based pharmaceutical drugs for various indications. Backed by a partnership with Mor Research Applications, the technology transfer company of Clalit Health Services, CannaMore leverages cutting-edge research to bring innovative treatments to patients in need. As a clinical research platform, CannaMore run multiple potential projects, with IcBD in colitis as the leading flagship, CannaMore is at the forefront of cannabinoid-based medical advancements. For further information, contact [email protected]. SOURCE CannaMore Biotechs

临床2期临床结果

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