Dubai

Researchers are evaluating the safety, tolerability, and effectiveness of two drugs, inebilizumab and blinatumomab, in adults with active and refractory autoimmune diseases such as systemic lupus erythematosus SLE with nephritis and rheumatoid arthritis RA. This phase 2, open-label, multicenter trial aims to better understand how these drugs work in these conditions and their impact on disease activity and kidney health. Participants will receive inebilizumab through intravenous IV infusions in different dosing schedules, or blinatumomab through subcutaneous SC injections at varying doses depending on the subprotocol group. The study includes several parts focusing on different autoimmune conditions and treatment regimens, with some parts no longer recruiting new participants. During the trial, participants will undergo regular assessments including monitoring for adverse events, evaluation of disease activity using specific clinical scores, kidney function tests, and antibody levels. Researchers will track safety and treatment responses over a period of up to 52 weeks, with visits occurring at scheduled intervals to collect data and monitor participant health.

Researchers are evaluating the effectiveness, safety, and tolerability of camizestrant combined with ribociclib in patients with advanced ER-positive, HER2-negative breast cancer who have not received any prior systemic treatment for their advanced disease. This Phase IIIb global, multicenter, single-arm study aims to provide insight into this combination therapy as a first-line treatment option. Participants will receive daily oral tablets of camizestrant 75 mg and ribociclib 600 mg at standard doses continuously until they choose to stop treatment or it is discontinued for any reason. Approximately 150 participants will be enrolled and treated within this trial. During the study, participants will be monitored for treatment effectiveness using time to next treatment, time to discontinuation, and progression-free survival over a two-year period. Safety will be assessed by tracking adverse events, including any severe toxicities within the first six months. Participants will undergo regular assessments related to organ function and performance status throughout the treatment period, which may last until discontinuation.

Researchers are observing the use of the drug elafibranor in people with Primary Biliary Cholangitis PBC, a rare progressive liver disease that damages bile ducts and can lead to liver scarring. The study aims to collect real-world information on how effective, safe, and tolerable elafibranor is for participants receiving this treatment. The total participation lasts about 5 years for each person. Participants in the study are those who have been diagnosed with PBC and are either starting or currently receiving treatment with the commercialized drug elafibranor. The study does not intervene with treatment but monitors participants as they use the drug in routine care. Data is collected during regular physician follow-up visits over the 60-month period. During the study, researchers will assess response to treatment at 6 months and continue monitoring various health measures such as liver function tests, symptom scales for itching and fatigue, quality of life questionnaires, and liver stiffness. They will also track adverse events, treatment satisfaction, and adherence throughout the study. Follow-up is based on routine medical visits, with no extra visits required specifically for the study.

Researchers are evaluating the safety and effectiveness of oral Apabetalone combined with background dapagliflozin treatment for up to 12 weeks in adults with type 2 diabetes mellitus T2DM who have experienced probable or confirmed COVID-19 infection. Participants must have symptoms of Long COVID lasting at least 2 months within 3 months from the start of COVID-19, which cannot be explained by other diagnoses. This phase II, open-label multicentre trial aims to better understand treatment options for this group of patients. Participants will take oral Apabetalone 100 mg capsules twice daily with meals while continuing their daily dapagliflozin 10 mg therapy for diabetes. The study involves seven in-person clinic visits where data will be collected to assess the treatments effects. After screening and consent, eligible participants begin Apabetalone treatment on Day 1 and continue it at home under study supervision. During the trial, participants will undergo various assessments including symptom evaluations and functional status tools related to Long COVID. The primary outcome is the patient acceptable symptom state at 90 days. Secondary measures include fatigue, dyspnea, and post-exertional malaise assessments. Safety and adherence will be monitored throughout, with the total study duration covering treatment and follow-up visits over approximately 12 weeks.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are comparing the accuracy of two denture impression methods for adults who have lost all their teeth. This study evaluates whether digital intraoral scanning matches the accuracy of conventional border-molded impressions in capturing mouth shapes, including movable gum areas. The study also examines if repeated digital scans are consistent when taken multiple times on the same patient. Participants will have their fully edentulous upper andor lower jaw scanned three times using a TRIOS 5 intraoral scanner following a structured sequence to capture the full arch including the palate and ridge slopes. After digital scans, each participant will also receive a conventional impression using a custom tray and border molding technique. Both procedures occur during two visits at Dubai Dental Hospital. Participants will provide informed consent and attend two study visits where scans and impressions are taken. Researchers will analyze the accuracy by measuring the difference between digital and conventional impressions and assess the precision of repeated digital scans. The main outcomes include the mean deviation between the two methods per arch and precision within repeated digital scans. Secondary outcomes compare differences between upper and lower jaws and between fixed and movable gum areas. Participation lasts about one week for outcome assessment.

Researchers are evaluating new diagnostic methods for asthma and chronic obstructive pulmonary disease COPD that can be used in primary care settings. Traditional spirometry relies on patients ability to perform forceful breathing maneuvers, which can be challenging and limit accurate diagnosis. This observational study aims to assess how well oscillometry and fractional exhaled nitric oxide FeNO testing work compared to specialist diagnosis, across six countries in the Middle East, Africa, Asia, and Latin America, to improve early and reliable detection of asthma and COPD. Primary care physicians will be trained to use oscillometry and FeNO testing following international guidelines and will use devices like the Ambulatory Lung Diagnosis System. Patients suspected of having asthma or COPD will be assessed through history, symptom questionnaires, and these tests. If specialist evaluation is not possible on the same day, it will occur within three days. No follow-up visits are planned. The study compares diagnosis accuracy and feasibility between primary care and specialist settings. Participants will provide consent and complete symptom questionnaires, followed by primary care assessments including oscillometry and FeNO testing. Researchers will measure the accuracy of primary care diagnoses against specialist diagnoses using statistical methods and observe agreement, sensitivity, and specificity within one to three days. The study does not require further follow-up, aiming to inform integration of these diagnostic tools into routine primary care for better asthma and COPD identification.

Researchers are studying real-world treatment patterns, patient characteristics, survival outcomes, and safety of Trastuzumab Deruxtecan T-DXd in women with hormone receptor-positive metastatic breast cancer mBC that is HER2-low or HER2-ultralow. This study focuses on patients previously treated with endocrine therapy and aims to provide data from Gulf Cooperation Council countries to improve treatment strategies and clinical guidelines for mBC in the region. This observational study monitors patients who have initiated T-DXd treatment as part of routine care, including those who started the drug up to 30 days before consenting to participate. It includes women aged 18 years or older with confirmed HR-positive, HER2-low or ultralow metastatic breast cancer who have not received chemotherapy in the metastatic setting. The study collects data over 18 months on treatment patterns, safety, and progression-free survival. Participants are observed while receiving their usual medical care with T-DXd, without additional intervention by the study team. Researchers collect information on patient characteristics, treatment details, safety events, and time to next treatment. The main outcome measured is real-world progression-free survival at 18 months, along with safety profiles and treatment patterns. The study is expected to last until March 2029, supporting improved outcomes through real-world evidence.

Researchers are evaluating whether transferring a single genetically normal embryo during a natural menstrual cycle without routine luteal phase support LPS is not worse than transferring with LPS. This study focuses on women with regular ovulatory cycles who have at least one genetically tested embryo available, aiming to simplify treatment and improve participant comfort if the outcomes are similar. Participants are randomly assigned to one of two groups. Both groups will have intermittent ultrasounds and blood tests measuring hormone levels to monitor ovulation. In the group without LPS, embryo transfer is scheduled five days after ovulation without additional progesterone support. The group receiving LPS will be given vaginal progesterone starting on the day of embryo transfer and continuing until the pregnancy test, with support extended to seven weeks if pregnancy occurs. Throughout the study, participants will undergo multiple hormone measurements and ultrasounds to track follicular growth and hormone levels before and after embryo transfer. Pregnancy confirmation will occur via blood tests 10 days after transfer. The study will measure implantation rate, clinical pregnancy rate, live birth rate, and hormone levels at specific time points. Participant involvement includes frequent clinic visits for monitoring and blood draws over the course of the treatment cycle and early pregnancy period.