Dubai

Researchers are observing the use of the drug elafibranor in people with Primary Biliary Cholangitis (PBC), a rare and progressive liver disease where bile ducts are damaged. This damage can lead to scarring of the liver (cirrhosis) and is often linked with symptoms like itching and fatigue. If PBC worsens, it may require a liver transplant or could be fatal without one. The study aims to understand how effective, safe, and tolerable elafibranor is for those being treated in everyday clinical settings. Participants in this study will be those who have been diagnosed with PBC and are either starting or already receiving treatment with commercial elafibranor at a dose of 80 mg per day. The study is non-interventional, meaning it observes participants as they receive their usual care without altering treatment. The total study duration for each participant is approximately 60 months, or 5 years. During the study, researchers will gather information about participants’ responses to treatment, safety, and tolerability over time. Outcome measurements include the percentage of participants who respond to treatment after 6 months. Participants and their caregivers may complete questionnaires, and researchers will monitor treatment effects and side effects throughout the study period to better understand how elafibranor works in real-world use.

Researchers are evaluating the safety and effectiveness of oral Apabetalone combined with dapagliflozin in adults with type 2 diabetes mellitus (T2DM) who have a history of probable or confirmed COVID-19 infection and continue to experience long-lasting symptoms for at least two months. This open-label, multicenter phase II clinical trial focuses on patients whose symptoms began within three months of COVID-19 onset and cannot be explained by other causes. Participants will take oral Apabetalone 100 mg capsules twice daily with meals for up to 12 weeks while continuing their background dapagliflozin therapy at 10 mg daily. The study includes seven in-person clinic visits where data will be collected to assess the treatment's effects. After screening and eligibility confirmation, participants start the Apabetalone treatment on Day 1 and take the medication at home. During the study, participants will undergo various assessments including symptom evaluation, laboratory tests, and questionnaires to monitor their condition and response to treatment. The primary outcome is the patient acceptable symptom state measured at 90 days. Safety and treatment adherence will be closely monitored throughout the study, which involves regular visits over the treatment period.

Researchers are evaluating the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

WAYFIND-R is a global registry focused on collecting high-quality real-world data from cancer patients diagnosed with solid tumors who have undergone next-generation sequencing (NGS) testing. The registry aims to support clinical and epidemiological research, generate evidence to better understand health outcomes and cancer care, and describe treatments and clinical courses for these patients. Participants must be adults diagnosed with any type of solid tumor at any disease stage and have had NGS testing within three months before enrollment. The study collects data without assigning specific treatments or interventions, instead tracking clinical characteristics and outcomes over time. During the study, researchers will gather information linking NGS results to treatments and patient outcomes, including overall survival for up to five years from enrollment. Participants provide informed consent, and data collected will help improve understanding of solid tumor cancers and their management in real-world settings.

Researchers are evaluating the accuracy of two denture impression methods in adults who have lost all their teeth. This study compares digital intraoral scanning using the TRIOS 5 scanner to conventional border-molded impressions made with custom trays. The goal is to determine if digital scans can capture the mouth shape as accurately as the traditional method and if repeated digital scans are consistent when taken multiple times. Participants will have their fully edentulous upper and/or lower jaws scanned three times during a single visit using the digital intraoral scanner to assess precision. Afterward, a conventional impression will be taken using a custom tray and border molding technique. Both digital and conventional impressions will be compared to see if digital scanning matches the "gold standard" impression method. Participants will attend two study visits at Dubai Dental Hospital where their mouths will be scanned and impressions taken. The study measures the trueness and precision of the digital impressions compared to conventional scans by analyzing root mean square deviations. Participants must provide informed consent and allow their impression data to be analyzed for accuracy. The study includes adults aged 18 to 85 who are fully edentulous and in good physical health.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are studying the safety, tolerability, and early effects of crofelemer in children with Microvillus Inclusion Disease (MVID), a rare congenital disorder. This Phase 2 trial uses a randomized, double-blind, placebo-controlled, dose-escalating design with a crossover placebo comparison at each dose level. The study aims to observe changes in physical exams and laboratory values over 32 weeks, focusing on participants receiving parenteral support (TPN with or without IV fluids). Participants will receive crofelemer powder for oral solution or a matching placebo, given three times daily either by mouth or through an existing G-tube or GJ-Tube (not J-tube). The study involves three increasing dose levels with cross-over between crofelemer and placebo within each dose group. The blinded medication is reconstituted as a concentrated liquid for administration during the treatment periods. During the 32-week study, participants will be monitored for safety and tolerability alongside changes in physical and laboratory assessments. Data from an 8-week pre-treatment baseline will be compared with treatment periods. Researchers will collect information on adverse reactions, treatment effects, and overall participant health to assess crofelemer's impact in this pediatric MVID population.

Researchers are evaluating the accuracy and feasibility of using oscillometry and fractional exhaled nitric oxide (FeNO) testing as diagnostic tools for asthma and chronic obstructive pulmonary disease (COPD) in primary care settings. The study addresses limitations of traditional spirometry, such as the need for forceful breathing maneuvers and specialized equipment, which can hinder timely diagnosis. This cross-sectional, observational study is conducted across six countries in the Middle East, Africa, Asia, and Latin America, comparing primary care diagnosis with specialist assessments. Primary care physicians will be trained to perform oscillometry and FeNO testing using standardized protocols and devices like the Ambulatory Lung Diagnosis System, following Global Initiative for Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. Eligible patients with suspected asthma or COPD will undergo symptom questionnaires and these diagnostic tests during a single visit. If specialist evaluation cannot be completed the same day, it will occur within three days. No follow-up visits are planned. Participants will provide informed consent and complete history and symptom questionnaires. Researchers will assess diagnostic accuracy by comparing primary care test results with specialist diagnoses, measuring agreement, sensitivity, and specificity over 1 to 3 days. The study aims to inform the potential integration of oscillometry and FeNO testing into routine primary care to improve early, reliable diagnosis of asthma and COPD, without requiring extended follow-up.

Researchers are evaluating whether transferring a single euploid embryo in a natural cycle without routine luteal phase support (LPS) is as effective as transfers with LPS. The study focuses on women aged 18 to 40 years with regular ovulatory cycles who have at least one tested euploid embryo. If the study shows no difference in live birth rates, it could simplify treatment and improve patient comfort. Participants will undergo monitoring with intermittent transvaginal ultrasounds to track follicle growth and serial blood tests measuring luteinizing hormone (LH), estradiol (E2), and progesterone (P4) to confirm ovulation. The group receiving LPS will be given vaginal progesterone starting on the day of embryo transfer (ET), with dosing adjusted up to 300 mg daily until pregnancy testing. The study compares outcomes between those who receive vaginal progesterone and those who do not. Throughout the study, participants will have blood tests to measure hormone levels on the day of ET and several days afterward. Pregnancy confirmation is done by measuring serum hCG 10 days post-ET. Key outcomes assessed include implantation rate and clinical pregnancy rate at 2 months, as well as live birth rate after 41 weeks. Hormone levels will be closely monitored to understand their relationship to pregnancy success.

Researchers are investigating how to best increase the width of keratinized mucosa (KM) at dental implant sites, a factor that affects gum health and comfort. This study compares a traditional free gingival graft (FGG) procedure with a newer meshed free gingival graft (mesh-FGG) technique over one year. The goal is to see if the mesh-FGG provides similar improvements in KM width but with less patient discomfort and post-surgical morbidity. Participants will receive either a conventional free gingival graft or an expanded meshed free gingival graft at implant sites where the KM is less than 2 mm wide. Both procedures aim to increase the KM width to improve gum health around implants. The mesh-FGG technique uses a modified graft that spreads out like a mesh to reduce the size of the tissue taken from the palate, potentially lessening patient morbidity. The study is a randomized controlled trial conducted at multiple centers. During the study, participants will be monitored for changes in the width of keratinized mucosa for up to one year. Researchers will assess gum health, patient comfort, and healing progress. The main outcome measured is the change in KM width. Participants must be systemically healthy adults with specific implant conditions and will undergo oral hygiene assessments to ensure suitability. Safety and effectiveness of both graft techniques will be carefully evaluated throughout the study period.