Clinical trials

The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).

This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.

The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.

The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East

This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa. The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS. Study details include: The study duration (per participant) will be up to approximately 164 weeks for participants transitioning into the long-term extension (LTE) period and will be up to approximately 60 weeks for participants not transitioning into the LTE period. The randomized treatment duration will be up to approximately 152 weeks

The aim of this research is to identify pre-symptomatic Type 1 Diabetes (T1D) in young children and adolescents who have first degree relatives with T1D. This protocol has been developed to address the growing need for standardized T1D screening, monitoring, and data collection in alignment with international recommendations. The study's estimated duration is 13 months and will consist of two visits: Visit 1 (screening visit) and Visit 2 (confirmatory visit).

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multi-country, multi-center, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with or without a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of regimens (durvalumab-based or otherwise) in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, treatment provider characteristics, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, time to treatment discontinuation, recurrence-free survival, and time to treatment recurrence).

The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.

BEYOND study is designed to generate the first real-world data from GCC countries on the patient characteristics, treatment patterns, survival outcomes, and safety of T-DXd in patients with HRpositive,HER2-low or HER2-ultralow mBC previously treated with ET. The evidence generated will help to optimise treatment strategies, inform clinical guidelines, and ultimately improve outcomes for patients with mBC across the region.

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions. The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.

Primary Objectives: To demonstrate that HT-4253 improves the amyloid risk profile by transitioning biomarker-positive APOE4 carriers from a positive, high risk APS2 score to a negative, low risk APS2 score. Secondary Objectives: * To assess the effects of HT-4253 on tau related blood biomarker progression over the study period. * To assess the effects of HT-4253 on amyloid related blood biomarker progression over the study period. * To assess the safety and tolerability of HT-4253 in the UAE population.

This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).

The goal of this clinical trial is to evaluate whether a precision lifestyle medicine intervention can improve cardiometabolic health in Emirati adults aged 25 to 50 years living in Abu Dhabi with obesity (BMI 30-35 kg/m²) who have previously completed IFHAS screening. The study will also use IFHAS screening data to better understand participants' health profiles and the relationship between lifestyle factors and chronic diseases. The main questions it aims to answer are: * Does a precision lifestyle medicine program improve cardiometabolic biomarkers after an 18-week intervention? * Can IFHAS screening data be used to identify health risk profiles and support personalized lifestyle interventions for the Emirati population? Researchers will compare participants receiving the precision lifestyle medicine intervention with a propensity-matched control group receiving standard IFHAS care to determine whether the intervention leads to greater improvements in cardiometabolic health. Participants will: * Take part in an 18-week personalized lifestyle medicine program tailored to their health profile. * Attend study visits and complete health assessments over a total study period of 24 weeks. * Undergo cardiometabolic biomarker assessments before and after the intervention. * Complete questionnaires or assessments about their adherence to the lifestyle program and their experience with the precision lifestyle medicine clinic. * Provide biological samples to support the establishment of a biomarker repository for future research.

The goal of this clinical trial with an embedded observational phase is to evaluate whether a phenotype-guided, personalized rehabilitation program can improve fall risk and underlying neural control mechanisms in older adults aged ≥65 years, including both high and low fall-risk individuals. The main questions it aims to answer are: Do older adults at high fall risk exhibit altered neural, neurocognitive, and biomechanical profiles compared with low/no fall-risk individuals? Does personalized rehabilitation guided by neurophysiological and neurocognitive profiles result in greater reductions in fall risk and improvements in motor control compared with conventional rehabilitation? Researchers will compare personalized phenotype-guided rehabilitation to conventional evidence-based fall-prevention exercise to determine whether targeted, mechanism-based intervention leads to superior clinical and mechanistic outcomes. Participants will: Undergo a comprehensive multimodal assessment including neurophysiological (EEG, EMG), neurocognitive (fNIRS, dual-task testing), and biomechanical (gait and balance) measures Be classified into fall-risk and neurophysiological control profiles based on assessment results (Phase 2 - high fall-risk participants only) be randomly assigned to either personalized rehabilitation or conventional rehabilitation Attend supervised exercise sessions 2-3 times per week for 8-12 weeks Complete gait, balance, and cognitive-motor assessments before and after the intervention Record falls prospectively using monthly fall diaries and follow-up monitoring over 3-6 months

This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.

A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.

This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.

Recurrent pregnancy loss (RPL), commonly referred to as recurrent miscarriage, affects approximately 1-2% of couples attempting to conceive. In nearly half of these cases, no definitive cause can be identified despite thorough clinical evaluation. A circumstance that is both distressing and disorienting for affected families, particularly in settings such as the United Arab Emirates (UAE), where childbearing carries significant personal and cultural weight. One leading hypothesis is that the underlying problem may not lie with the embryo itself, but with the way the mother's immune system responds to a developing pregnancy. Under normal physiological conditions, the maternal body must establish immune tolerance toward an embryo that is genetically half-foreign in origin. In some women, this tolerance mechanism may be impaired, reducing the likelihood that a pregnancy will successfully implant and progress. This study will evaluate whether granulocyte colony-stimulating factor (G-CSF) a naturally occurring substance that normally stimulates the production of immune cells can help address this issue by modulating an overactive immune response and enhancing the uterine environment's capacity to support pregnancy. Notably, the study will enroll only women whose embryos have undergone genetic testing and been confirmed to be chromosomally normal. This eliminates embryo quality as a contributing factor to pregnancy loss and allows for a clearer assessment of whether G-CSF itself influences outcomes. Earlier small-scale studies, including preliminary work conducted at our own centre, have shown encouraging results. This new trial builds on that foundation by enrolling a larger cohort, comparing G-CSF against a placebo (an inactive comparison treatment), and evaluating a simpler route of administration; subcutaneous injection, rather than direct infusion into the uterus. Together, these design features aim to provide the most reliable evidence to date on whether this treatment can meaningfully help couples affected by unexplained recurrent pregnancy loss.

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

The goal of this quasi-experimental interventional study is to learn if healthy cooking classes for home cooks can improve weight management and dietary quality among Emirati adults with overweight or obesity living in Abu Dhabi. The main questions it aims to answer are: * Does participation in the culinary medicine program reduce body weight over time? * Does the intervention improve diet quality and increase compliance with healthy home-cooked meals? * Does the intervention improve health measures such as waist circumference, body fat percentage, blood pressure, and heart rate? * What are the experiences and satisfaction levels of participating family members and trained home cooks? Participants will: * Enroll in a 3-month family-based nutrition intervention program * Receive meals prepared by home cooks trained in culinary medicine through the ICCA program * Complete assessments before the intervention, during the intervention, and 3 months after completion * Undergo measurements including weight, waist circumference, body fat percentage, blood pressure, and heart rate * Complete questionnaires about diet quality, meal habits, and overall program experience

Vitamin D is best known for keeping our bones healthy, but growing research suggests it may also play a role in fertility. Many In vitro fertilization (IVF) clinics now routinely check vitamin D levels and prescribe supplements before treatment, but the science is still unclear on whether this actually improves the chances of pregnancy. Our study, based in the United Arab Emirates (UAE), aims to find out whether a woman's vitamin D level on the day of her frozen embryo transfer (FET) makes a difference to whether she becomes pregnant and delivers a baby. The UAE is an ideal setting for this research, as vitamin D deficiency is particularly common in the region. The findings could shape how fertility clinics screen and treat women seeking fertility treatment in the future.