Maung Khon Kaen, Thailand

Cultural Adaptation of a Web-Based App (myPlan Thailand) to Empower and Support Friends and Family of Intimate Partner Violence Survivors

Postoperative Atrial Fibrillation in Cardiac Surgery

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery, with incidence rates reported between 15-30% after valve surgery and 18-74% after coronary artery bypass grafting. POAF typically occurs within 72 hours after surgery and is associated with increased morbidity, mortality, length of hospital stay, and healthcare costs. The Society of Thoracic Surgeons has identified five major postoperative complications associated with cardiac surgery, including POAF, which can significantly affect patient outcomes. This multicenter observational study will examine the incidence and risk factors of POAF in cardiac surgery patients across three medical centers in Thailand: Srinagarind Hospital at Khon Kaen University, Northeastern Thailand Cardiac Center, and Surat Thani Hospital. The study will collect data on patient demographics, comorbidities, preoperative laboratory values, perioperative characteristics, surgical procedures (valve surgery, CABG, combined procedures), and postoperative complications. By identifying risk factors associated with POAF, this study aims to develop preventive strategies and improve management protocols for patients at high risk for this complication.

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm. This study will be conducted at up to 200-250 sites globally in approximately 25 countries.

A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children

This is an exploratory, observational, pilot study that aims to build and measure the accuracy of an algorithm that estimates a child's iron status using images and/or videos, against gold standard venous blood sampling. Images and/or videos will be collected by healthcare professionals, together with blood test results. This data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. Data on the acceptance and experience of the using the algorithm will be collected for improvements.

Effects of Preparatory Information on Anxiety and Treatment Adherence in Heart Surgery Patients

• Participant invitation The study invitation for the prospective participants who are patients scheduled for heart surgery is posted at the cardiothoracic surgery outpatient clinic. Before deciding, patients who are interested in participating can get in touch with the researchers to learn more about the study. Additionally, the invitation will also be posted at the in-patient facilities where patients are being admitted for heart surgery so the nurses to ask patients for their interest in being the study volunteers. The researchers will be notified if there are potential participants. - Recruitment and consent process The researcher will meet with prospective participants in in-patient units where they are being admitted for surgery to discuss the study details and evaluate the Abbreviated Mental Test for screening. Potential participants who have an AMT test score of less than 8 will be excluded and thanked for their volunteer. The consent will be signed by the patients who agree to participate. The meeting will take place between 6:00 and 8:00 p.m. after patients have completed all preoperative preparations and have had dinner. - Research assistants Two research assistants in this study are registered nurses with more than 3 years of experience in caring for heart surgery patients. They were trained to follow the study protocol and use research instruments. The interrater reliability between the researchers and research assistants is 0.96. To avoid bias, the research assistants will evaluate the outcomes in both the experimental and comparison groups while remaining blind to group allocation. - Sample size estimation The sample size estimation was calculated using the G*Power 3.1.9.7 program for a two-sample t-test for independent with 0.8 effect size from Cohen's d formula (Cohen, 1988) using mean anxiety from a similar study. The estimated sample size needed for this study is 21 for each group with 10% adjusted for attrition resulting in 24 participants necessary for each group to demonstrate an effect. - Data collection Data collection starts once the participants sign the consent. The participants will be allocated to a group with computer computer-generated program. Allocation to the group cannot be concealed from the participants but will be blinded to the research assistants who evaluate the outcomes. In the experimental group, the researcher asks participants to rate their anxiety before receiving the intervention (12-minute preparation information video + usual preparation information) while in the comparison group, only usual preparation information is given. The participants rated their anxiety again 30 minutes after the intervention and the usual information was given. The experimental group will receive the preparation VDO again the day before surgery. Participants in both groups rate their anxiety 48 hours after surgery and are evaluated for treatment adherence during their ICU stay. Participants who are unable to participate until the completion of the trial for any reason will be withdrawn from the study and analysis. Individual participant identities will not be recorded or disclosed in any way. Data analysis will be used to identify groups, and all recorded information will be deleted two years after the study is completed. - Data analysis The data analysis will be performed using the Statistical Package for the Social Sciences (SPSS) version 28 software with a confidence interval of 95% (α=0.05). Descriptive statistics, Chi-square test, ANOVA, and Mann-Whitney U test will be analyzed to evaluate demographic differences between the groups depending on the normality assumption. Repeated measures ANOVA and ANCOVA will be used to analyze differences in anxiety and treatment adherence within the groups and between the groups, respectively. However, if the normality assumption is not fulfilled, the Mann-Whitney U test and Chi-square will be performed.

COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors

Gynecological cancers, encompassing ovarian, endometrial, and cervical cancers, stand as significant health concerns for women. In 2017, a total of 12,354 new cases were diagnosed in Thailand, underlining the prevalence and impact of these conditions. Advances in cancer screening and treatment have notably improved outcomes, resulting in a growing number of survivors. By 2016, the United States alone recorded 15.5 million cancer survivors, with projections indicating a surge to 26.1 million by 2040. However, even with increased survival rates, challenges persist for survivors, encompassing chronic pain, complications from treatment, and disruptions to fertility, menopause, sexual function, and cognitive health. The treatment landscape for gynecological cancers is diverse, with the general principle for ovarian and endometrial cancers involving surgical staging. This comprehensive approach includes the removal of the uterus, fallopian tubes, both ovaries, peritoneum, pelvic lymph nodes, and any visible lesions. For cervical cancer, treatment varies based on disease stage. Early-stage cases often undergo surgery, potentially followed by pelvic irradiation. In advanced-stage cervical cancer, a combination of pelvic radiation and chemotherapy is commonly employed. In summary, many gynecological cancer treatments involve the removal of both ovaries or pelvic irradiation, inducing menopause in reproductive-age women. The female lower reproductive system, including the lower urinary tract, is intricately responsive to estrogenic stimulation. When estrogen is lacking, structural changes occur, giving rise to a cluster of symptoms collectively termed the genitourinary syndrome of menopause (GSM). Estrogen deficiency results in thinning of the vaginal epithelium lining, diminished collagen and elastin fibers, reduced blood supply, and moisture decline. These changes manifest as vaginal symptoms, including burning, itching, and pain during intercourse. Similarly, the urinary tract, deprived of estrogenic stimulation, undergoes alterations such as urethral shortening, thinning of the urethral epithelium, weakened urethral sphincter contractions, and reduced elasticity of the urinary bladder. This cascade of changes results in lower urinary tract symptoms, comprising dysuria, urinary urgency, incontinence, frequency, nocturia, and recurrent urinary tract infections. Postmenopausal women commonly experience these symptoms, and systematic literature reviews reveal a prevalence ranging from 13 to 87%. Furthermore, the chronic nature of these symptoms tends to intensify over time. Women who undergo early bilateral oophorectomy are more likely to enter menopause sooner, increasing the risk of developing various urogenital symptoms at a younger age. The impact of these symptoms on women's lives is profound, affecting daily activities, self-confidence, and intimate relationships. Vaginal symptoms, in particular, can lead to sexual dysfunction, exacerbating challenges in family relationships. Concurrently, urinary symptoms contribute to decreased quality of life, with frequency, nocturia, and urgency correlating with the risk of falls and bone fractures. Additionally, these symptoms are associated with depressed mood, anxiety, and embarrassment, further disrupting aspects of life such as sleep, daily commute, social interactions, and sexual relationships. Despite the significant impact on quality of life, the effective management of vaginal and genitourinary symptoms is impeded by various factors. These include a lack of knowledge and understanding of the diseases and available treatment options, feelings of embarrassment, and the notable observation that medical personnel often fail to inquire about these specific issues during patient consultations. The primary treatment for genitourinary symptoms is typically the use of vaginal estrogen. However, certain gynecological cancers, such as leiomyosarcoma, endometrial stromal sarcoma, and specific ovarian cancers, preclude the use of estrogen therapy. In such cases, non-hormonal alternatives like vaginal lubricants, moisturizers, and energy-based devices come into consideration. This study aim to explore the prevalence of GSM among gynecological cancer survivors. The investigation extends to understanding the magnitude of the problem, examining women's attitudes towards the condition, and assessing its broader impact on their quality of life. This comprehensive exploration seeks to contribute valuable insights to the understanding and management of the complex challenges faced by gynecological cancer survivors.

A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

Thailand ATTR-CM Registry