Clinical trials

The aim of this study is to evaluate, in adults with HFrEF in Sri Lanka, the effects of an HFrEF polypill implementation strategy on the composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations, compared with usual care over a minimum of 12-months of follow-up. Primary outcome of the study: 1\) Composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations over study duration Secondary outcomes of the study: 1. Rate of cardiovascular disease mortality over study duration 2. Rate of recurrent heart failure hospitalizations over the study duration 3. Rate of all-cause mortality over the study duration 4. Change in left ventricular ejection fraction at 12-months and end of study assessed by transthoracic echocardiogram 5. Change in BNP levels at 12 months and end of study 6. Change in overall and domain specific health-related quality of life at 12-months and end of study assessed by a translated validated version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) 7. Change in physician-reported New York Heart Association class at 12-months and end of study 8. Adherence to guideline-directed medical therapy assessed by pill count and MARS-5 questionnaire at baseline, 1-, 6-, 12-months, and end of study. Persistence assessed as continuation of assigned therapy at each follow-up visit. Dose optimization assessed as proportion achieving target doses (Strength 3 of the polypill, or comparable individual GDMT doses in the comparator arm) at 6-, 12-months, and end of study. Safety outcomes: 1. Proportion of participants with serious adverse events according to Good Clinical Practice guidelines over study duration 2. Proportion of participants with adverse events of special interest over study duration 3. Proportion of participants with adverse events leading to HF drug discontinuation over study duration 4. Mean change from baseline to 12-months and end of study in serum potassium (mEq/L) 5. Mean change from baseline to 12-months and end of study in serum creatinine (mg/dL) Participants will be randomly assigned 1:1 stratified by sex and site to one of two groups, intervention (experimental arm) or usual care (control arm). The intervention group will be given four guideline-recommended medications for heart failure with reduced ejection fraction, combined in one over-encapsulated pill, with three dose strength options. Both groups will be observed over a minimum of 12-months of follow-up to assess key outcomes.

This study includes a survey of primary healthcare facilities in Nigeria and Sri Lanka. It will aim to assess the availability and readiness of hypertension care in primary healthcare facilities, and feasibility to conduct a future randomised controlled trial. This study also includes a survey of patients with high blood pressure who will be recruited from primary care in Sri Lanka and Nigeria. Its aim is to understand the characteristics of patients with hypertension, hypertension management and control, including use of pharmacological interventions and lifestyle management. Patients will have their blood pressure, height and weight measured. They will also be asked about their age, sex/gender, socio-economic status, medical history, and health behaviours and lifestyle. Additionally, this study includes focus group discussions and in-depth interviews with adults with high blood pressure and their carers; healthcare providers (community health workers, nurses, and doctors or physicians); clinic administrators; and policymakers. The discussions and interviews will aim to explore experiences, practices, and views on hypertension care and the new treatment strategies. Topics will cover experiences of current high blood pressure care; service availability, accessibility, and affordability; healthcare staff training and how well they follow medical guidelines for helping patients with high blood pressure; what works well and what are the problems with helping patients with high blood pressure; experiences of patients who need help with their high blood pressure; and how well new ways of helping people with high blood pressure are received.

Skin color, how easily a person burns or tans in the sun (skin phototype), and the amount of chronic sun damage in the skin are important factors in skin health. These characteristics influence a person's risk of skin cancer, how skin diseases appear, how well treatments work, and how accurately doctors and artificial intelligence (AI) systems can diagnose skin conditions. However, current methods for classifying these characteristics are often imprecise and rely heavily on subjective assessments. As a result, both healthcare professionals and patients may incorrectly classify skin type, which can lead to inaccurate risk assessments and less personalized care. This study aims to develop and validate AI algorithms that can accurately classify skin pigmentation, skin phototype, and accumulated sun damage using photographs of the skin. Unlike existing approaches, the study combines several different methods to create a more objective "ground truth" for training the AI. These methods include skin color measurements using spectrophotometry or colorimetry, assessments using the Monk Skin Tone Scale, questionnaires about sun sensitivity, and clinical evaluations by trained observers. By combining these data sources, the researchers hope to create a more reliable and scientifically robust classification system. The study will recruit adults aged 18 years and older from several countries, including countries from all continents. Participants will complete a questionnaire about their skin, propensity to burn and sun exposure history. Researchers will then take standardized close-up and dermoscopic images of the skin on the arm and forearm, measure skin pigmentation using objective instruments when available, and assess skin phototype and sun damage. No invasive procedures will be performed, and no personally identifiable information will be collected. The collected images and measurements will be used to train deep learning AI models. The researchers aim to develop algorithms that can classify skin pigmentation with at least 85% accuracy, skin phototype with at least 75% accuracy, and sun damage with at least 80% accuracy compared with the combined reference assessments. The algorithms will then be tested in independent datasets, including large dermatology image databases from Sweden, to evaluate how well they perform in different populations. The study has several potential benefits. More accurate classification of skin characteristics could improve personalized skin cancer risk assessments and allow prevention advice to be tailored to individual needs. This may help identify people who would benefit from closer surveillance and stronger sun protection recommendations while avoiding unnecessary restrictions for people at lower risk. Improved classification could also enhance the diagnosis and management of inflammatory skin diseases and skin cancers, which can appear differently in people with different skin tones. An additional goal is to address known biases in dermatology AI systems, which often perform less accurately in individuals with darker skin. By including participants with a wide range of skin tones and backgrounds, the researchers aim to contribute to the benchmarking of AI-driven medical devices wich hopefully can result in the development of fairer and more equitable AI tools. The study involves minimal risk. Only photographs of the arm and forearm will be taken, and researchers will avoid capturing tattoos, prominent scars, or other identifying features. All data will be stored securely and only accessible to authorized researchers. The potential benefits of improving skin disease diagnosis, skin cancer prevention, and fairness in medical AI are considered to outweigh the small privacy risks associated with participation.

This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \[FSGS\], treatment-resistant minimal change disease \[TR MCD\], primary immunoglobulin A nephropathy \[IgAN\], and primary membranous nephropathy \[PMN\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.

This is a stepped-wedge, cluster-randomized, two-arm, open-label, clinical trial of an electronic clinical decision support tool (eCDST) for the diagnosis and treatment of lower respiratory tract infection (LRTI) among patients at three sites in Southern Province, Sri Lanka. The primary objective of this trial is to determine the impact of an electronic clinical decision support tool (eCDST) on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group. The study will enroll 765 patients ≥ 14 years of age. Medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over. Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed (a maximum of 14 days).

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

Pesticide poisoning remains one of the most serious public health challenges in rural Sri Lanka, particularly in the North Central Province (NCP), where intensive farming and heavy pesticide use have led to high rates of accidental and intentional poisoning. Although the antidote, atropine, is routinely used in hospitals, delays in receiving treatment often occur because patients must travel long distances before reaching care. Early initiation of treatment is critical, and survival depends on the speed with which atropine is administered. The government's free 1990 Suwa Seriya ambulance service, established in 2016, provides emergency transport across Sri Lanka but currently has limited capacity for administering time-sensitive antidotes. Community consultations conducted during an earlier study revealed that people preferred life-saving treatments such as atropine to be managed through the formal health system, rather than stored in villages. This led to the idea of exploring whether ambulance staff could safely use atropine autoinjectors; simple, pre-filled devices that deliver the drug quickly and can safely be used even by non-medical professionals. The FAST-AID study aims to assess the feasibility of introducing atropine autoinjectors into Sri Lanka's emergency ambulance system for use in pesticide poisoning cases. The main question is: How feasible is it to integrate atropine autoinjectors into the ambulance service to provide earlier treatment for pesticide poisoning patients? Secondary questions explore (1) how ambulance coverage and travel routes affect timely administration; (2) how ambulance and hospital staff experience the use of the devices; and (3) how patients perceive the care they received. The study will be carried out in the Anuradhapura District of the NCP, in collaboration with the Suwa Seriya ambulance service and selected hospitals. Two geographical clusters, one densely populated and one more remote, have been chosen to compare different service conditions. Around 30 pesticide poisoning patients will receive atropine using autoinjectors during ambulance transport, under guidance from an on-call emergency physician. Data will be collected through several complementary methods: * Operational data from ambulance and hospital records (e.g., response times, use of autoinjectors, patient outcomes). * Geographic mapping (GIS) of ambulance coverage to assess accessibility and response patterns. * Focus group discussions with ambulance and hospital staff to explore training, practical challenges, and perceptions of the intervention. * Semi-structured interviews with patients to understand their lived experience of emergency care. * Participant observation in ambulances and hospitals to capture the everyday realities of emergency response. Participants will be adults (aged 18 or above) who either work in the ambulance or hospital system or who have experienced pesticide poisoning and received atropine during the study period. All participants will provide written informed consent. The research team will include Sri Lankan and UK collaborators from the University of Edinburgh and the South Asian Clinical Toxicology Research Collaboration (SACTRC). By assessing the operational and social feasibility of using atropine autoinjectors in ambulances, this study aims to strengthen Sri Lanka's emergency response system and provide a foundation for a larger trial that could ultimately help save lives of those experiencing pesticide poisoning.

CAPTIVATE is an international, multi-centre, Phase III, adaptive, platform, randomised controlled trial in people with chronic kidney disease (CKD). CAPTIVATE aims to find the best treatment, or combination of treatments, that slow the progression of CKD so that fewer people develop kidney failure. CAPTIVATE provides a research platform that allows many treatment-related questions to be answered within a common trial set-up.

The goal of this clinical trial is to learn if newly developed intervention package works to improve physical activity level among patients with intermediate cardiovascular risk factors. The main questions it aims to answer are: Does the INSPIRE-PA intervention increase the level of physical activity among participants with intermediate cardiovascular risk factors? * What changes occur in physical activity level, BMI and blood pressure following participation in the intervention? * Are there any challenges, barriers, or unintended effects experienced by participants during the intervention period? * Researchers will compare the INSPIRE-PA intervention to usual care to determine whether the empowerment-based strategy is effective in improving physical activity levels and reducing cardiovascular risk among patients attending government primary medical care Iinstitutions. Participants will: * Participate in the INSPIRE-PA program for 6 months * Attend scheduled follow-up visits at the primary medical care institution (e.g., every 2-4 weeks)for counselling, evaluation of physical activity level, and assessment of cardiovascular risk indicators * Engage in structured physical activity as recommended in the intervention package * Record their daily physical activity and any challenges or barriers in a physical activity logbook or diary * Undergo periodic measurements such as blood pressure, weight, waist circumference, and other relevant clinical assessments

The ICU-related Out-of-Pocket Expenses (ICOPE) study is a multinational, prospective observational study conducted in African and Asian countries to quantify ICU-related out-of-pocket expenditures and catastrophic health expenditure among patients and families. The study will include all patients admitted to participating ICUs during a predefined 14-day recruitment window, provided they have an ICU stay longer than 24 hours and informed consent is obtained. A minimum sample size of 354 patients is planned, including both ventilated and non-ventilated patients. Participants will be followed until ICU discharge, with additional follow-up at 30 days and 6 months after admission, resulting in a total study duration of 18 months. The primary objective is to quantify ICU-related out-of-pocket costs and assess the proportion of patients experiencing catastrophic health expenditure, comparing ventilated and non-ventilated groups, while secondary objectives include identifying risk factors for catastrophic expenditure and documenting coping strategies used by families to manage ICU costs.

Study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population. Study design Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study. Sample size The estimated sample size will be n=156. Duration of study 12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date) Safety Assessment: Patient will be monitored for Hypoglycemia, Dehydration, Hypotension, Urinary Tract Infections, Fungal Infections, Nausea, Vomiting, Diarrhea, Abdominal Discomfort, Flatulence, Asthenia, Indigestion and Other side effects (if any). Follow up visits: After recruitment, patient is supposed to have three visits for follow-ups. Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy. LABORATORY TESTING: Reputable Lab is considered for laboratory testing of diabetes patients i.e. HbA1C%, FBG, RFT and urine R/E. The certified clinical lab will be responsible for receiving and analyzing clinical sample. Patients will have special discount of upto 50% for study related laboratory investigations. Where in Urine Routine Examination (Urine R/E), we consider as follows: * Visual Examination: * Urine color: Normal (Yellow), Pale Yellow, Dark Yellow, Brown, Red or Pink or any other. * Urine clarity: Clear, slightly Cloudy, cloudy or turbidity * Chemical Examination: * Specific gravity * pH * Bilirubin * Urobilinogen * Protein * Ketone * Leukocyte Esterase * Microscopic Examination: * Red Blood Cells: * Epithelial Cells: * Amorphous: * Pus Cells * Bacteria * Yeast * Casts * Crystals Where in Renal Function Test (RFT), we consider as follows: * Blood Urea Nitrogen (BUN): mg/dL * Serum Creatinine: mg/dL * Estimated Glomerular Filtration Rate (eGFR): mL/min/1.73 m2

The purpose of this study is to investigate the potential of autologous adipose stem cell (ASC) mitochondrial transfer (ASCENT) to oocytes along with intracytoplasmic sperm injection (ICSI)as a means of enhancing embryo development and improving the success rate of in patients with a history of multiple IVF failures. Embryo quality plays a crucial role in determining the success of assisted reproductive technologies and directly contributes to repeated pregnancy failures. Several factors, including age, physiological conditions, genetics, and environmental influences, can significantly impact embryo quality. Oocytes, the largest cells in the human body, are heavily reliant on mitochondria. Mitochondria's role in providing energy for oocytes is crucial, and insufficient energy production has been linked to poor oocyte and embryo quality. Some human studies have shown that increasing oocyte mitochondrial mass can improve embryo quality in patients who have experienced repeated IVF failures.

The goal of this clinical trial is to assess and compare the efficacy of dry needling (minimally invasive treatment by using a tiny needle) combined with two types of stretching techniques in patients with neck pain for more than 3 months. The main questions it aims to answer are: Which combination of treatment will 1.give faster relief of pain? 2.improve neck range of motion? and 3.improve disability level of a person with neck pain. Participants who are interested will be selected according to eligibility criteria. Participants will be divided into two groups. Initially researcher will assess and interview the participants. Two groups will receive two different combinations of interventions. Pre and post measurements will be obtained and then treatment efficacy will be assessed.

The aim of the trial is to evaluate the effects of the SGLT2 inhibitor, dapagliflozin, compared to metformin on annual decline in eGFR when used as first line therapy in people with Type 2 Diabetes.

Lupus Low Disease Activity State (LLDAS) study is an international, multi-centre prospective study, developed by the Asia Pacific Lupus Collaboration (APLC) to investigate whether the attainment of LLDAS is associated with improved outcomes in patients with Systemic Lupus Erythematosus (SLE). SLE, or lupus, is the archetypal multisystem autoimmune disease, with an estimated incidence of 5-50 cases per 100,000 people. Patients with SLE, usually young women, suffer a marked loss of life expectancy, and severe morbidity, due to a heterogeneous range of clinical manifestations caused by autoimmune-mediated inflammation of multiple organs. The most severe manifestations of SLE are the accrual of irreversible organ damage, especially renal and central nervous system (CNS) involvement. As there is no effective targeted monotherapy for SLE, patients also suffer severe toxicity from the use of glucocorticoids and broad-spectrum immunosuppressive therapies. Despite combination therapy with current drugs, many studies show that the majority of patients suffer inadequate disease control and inexorably accrue permanent organ damage over time. The diversity of clinical features of active SLE has made quantification of disease activity problematic. Although there are a number of published systems in use to measure SLE disease activity, there are widely acknowledged problems with these instruments. Published definitions of remission are so stringent that they are met by less than 5% of patients. This lead to the realisation that rather than lupus remission, a lupus low disease activity state target may be more feasible, and that patients with low disease activity are more homogeneous than patients with active disease. Thus, the development of a definition of lupus low disease activity, which is feasible and has face validity, escapes the complexity of attempts to quantify heterogeneous states of active disease. In this study, the investigators will prospectively collect longitudinal data on consecutive SLE patients at each centre to evaluate the LLDAS definition. Protection from organ damage accrual as the primary endpoint.

Introduction: Oral cancer is a malignant neoplastic disease affecting the lip, oral cavity (mouth) and/or the oropharynx. Despite the intense and diverse public health interventions on oral cancer prevention, the global prevalence rates of oral cancer and its major risk factors are still very high. Hence, oral cancer is an issue of serious global health importance. Aim: To test and compare the effectiveness, usability, uptake, and acceptability of an educational website and a mobile health application prototype on oral cancer in improving oral cancer knowledge among university students. Methods: This study will adopt a randomised control trial design, and it will be conducted among 75 first-year bachelor's degree students from five universities across two continents: University of Rwanda (Rwanda, Africa), Usmanu Danfodiyo University (Nigeria, Africa), University of Peradeniya (Sri Lanka, Asia), University of Ibadan (Nigeria), and Saveetha University (India, Aisa). The study participants will be in three groups (Group 1, Group 2, and Group 3). The participants in Group 1 will be the control group (n = 25 participants; 5 participants from each university); that is the group that will not receive an educational intervention. However, those in Group 2 (n = 25 participants; 5 participants from each university) will receive a web-based educational intervention on oral cancer while those in Group 3 (n = 25 participants; 5 participants from each university) will receive an app-based educational intervention on oral cancer. Pretest survey and posttest survey will be done for all participants. The data collected will be statistically analysed using the Statistical Package for Social Sciences (SPSS) version 28 software. Descriptive statistics will be done for all variables while inferential statistics (analysis of variance) will be done to test for associations between variables of interest. Conclusion: The findings of this study will determine the effectiveness, usability, uptake, and acceptability of the tested digital intervention tools.

This interventional study is conducted with the goal of comparing the efficacy of traditional Buddhist mindfulness training versus secular mindfulness based cognitive therapy among patients with depressive disorders. We are also interested in studying how these interventions compare in terms of preventing further relapses of depression. Additionally, this study aims to identify factors that influence the efficacy of this intervention, such as self-report mindfulness, self-compassion, and religiosity.

One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year. Cooling therapy in the context of modern tertiary intensive care improves outcome after NE in high-income countries. However, the uptake and applicability of cooling therapy in LMICs is poor, due to the lack of intensive care and transport facilities to initiate and administer the treatment within the six-hours window after birth as well as the absence of safety and efficacy data on hypothermia for moderate or severe NE. Erythropoietin (Epo) is a promising neuroprotectant with both acute effects (anti-inflammatory, anti-excitotoxic, antioxidant, and antiapoptotic) and regenerative effects (neurogenesis, angiogenesis, and oligodendrogenesis),which are essential for the repair of injury and normal neurodevelopment when used as a mono therapy in pre-clinical models (i.e without adjunct hypothermia). The preclinical data on combined use of Eythropoeitin and hypothermia is less convincing as the mechanisms overlap. Thus, the HEAL (High dose erythropoietin for asphyxia and encephalopathy) trial, a large phase III clinical trial involving 500 babies with with encephalopathy reported that that Erythropoietin along with hypothermia is not beneficial. In contrast, the pooled data from 5 small randomized clinical trials (RCTs) (n=348 babies), suggests that Epo (without cooling therapy) reduce the risk of death or disability at 3 months or more after NE (Risk Ratio 0.62 (95% CI 0.40 to 0.98). Hence, a definitive trial (phase III) for rigorous evaluation of the safety and efficacy of Epo monotherapy in LMIC is now warranted.