Clinical trials

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).

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).

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).

Clinical trial evaluating the safety and efficacy of Thymosin-α1 (Tα1) as an adjunctive immunomodulatory therapy in women with unexplained recurrent implantation failure (RIF) undergoing IVF/ICSI cycles.

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

The aim of this study is to assess the safety, side effects and effectiveness of EP0031 (Lunbotinib) in patients with advanced RET-altered non-small cell lung cancer (NSCLC) in monotherapy and in combination with standard of care (SOC) chemotherapy.

Vitamin D is best known for keeping our bones healthy, but growing research suggests it may also play a role in fertility. Many 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 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.

The goal of this clinical trial is to learn whether an AI-powered carbohydrate counting educational platform can help parents of children with type 1 diabetes improve their carbohydrate counting skills and diabetes management. The study will include parents or primary caregivers of children aged 2-12 years with type 1 diabetes. The main questions it aims to answer are: * Is the AI-powered educational platform feasible, acceptable, and easy for parents to use? * Can the platform improve carbohydrate counting accuracy, parental confidence in diabetes management, and diabetes outcomes compared with usual education alone? Researchers will compare parents who receive access to the AI-powered carbohydrate counting educational platform plus usual diabetes education with parents who receive usual diabetes education alone to see whether the AI-supported approach provides additional benefits. Participants will: * Complete baseline assessments, including questionnaires and a carbohydrate counting test. * Be randomly assigned to either the AI-supported education group or the usual education group. * Use the assigned educational resources for 12 weeks. * Complete a follow-up assessment at 6 weeks and a final assessment at 12 weeks. * Provide information about their child's diabetes management, including HbA1c and glucose monitoring data. * Complete questionnaires about confidence, usability, and satisfaction with the educational support they receive. The AI platform is designed to provide educational support only and does not replace medical advice, insulin dosing decisions, or routine diabetes care provided by healthcare professionals.

Chronic Obstructive Pulmonary Disease is a leading cause of global morbidity and mortality, especially in low- and middle-income countries. Exacerbations accelerate disease progression and increase the risk of death. Recent recommendations from the GOLD report emphasize the diagnosis of COPD and treatment planning based on a combination of lung function metrics, exacerbation history, and patient-reported symptoms. It is recommending the use of triple combination therapy (ICS+LABA+LAMA) such as BREZTRI/TRIXEO as one of the options in Group E patients. While BGF has demonstrated efficacy in controlled clinical trials, real-world evidence is needed to assess its impact on daily patient outcomes and quality of life. The iCHOROS study is a real-world, international, multicenter, observational study aiming to evaluate changes in clinical and patient-reported outcomes in adults with moderate to severe COPD treated with BGF for 12 months in routine care settings across Latin America, Asia, and the Middle East \& Africa. The study will provide valuable insights into the effectiveness and patient experience of BGF therapy in diverse, real-world populations

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).

Periodontal disease remains a highly prevalent chronic inflammatory condition affecting the supporting structures of the teeth and is a leading cause of tooth loss worldwide. Contemporary periodontal therapy is structured into sequential phases, with non-surgical periodontal therapy (NSPT) forming the cornerstone of initial management. Following this phase, re-evaluation of periodontal status is critical to determine treatment outcomes and guide further intervention, including surgical therapy if required (1,2). Re-evaluation phase serves multiple purposes: it allows assessment of tissue response to therapy, measurement of reductions in probing pocket depth (PPD), gains in clinical attachment level (CAL), and evaluation of patient compliance with oral hygiene practices. It also aids in identifying residual pockets or persistent inflammation that may necessitate additional treatment (1,3). Despite its clinical importance, the optimal timing of re-evaluation remains inconsistently defined in the literature (1). Generally, current literature utilizes a timing frame from 1-3 months; up to 9 months (3,4). Current clinical guidelines, including those from the European Federation of Periodontology (EFP), generally recommend assessing whether the end points have been achieved; no periodontal pockets ≥ 5mm with bleeding on probing and no pocket ≥ 6mm (5). Emerging evidence suggests that certain clinical improvements, particularly reductions in inflammation and bleeding on probing (BOP), may occur as early as 4 weeks following therapy, raising questions about whether earlier re-evaluation could be clinically beneficial (2,3). Early reassessment may allow for more timely identification of non-responding sites, enabling prompt intervention and potentially improving overall treatment outcomes. Conversely, other studies indicate that full periodontal healing and maturation of tissues may require longer periods, supporting delayed re-evaluation intervals (1,2,3). Furthermore, patient-related factors such as systemic health, smoking status, and baseline disease severity may influence healing dynamics and thus the appropriate timing for reassessment (1). The heterogeneity of these factors highlights the potential need for a more individualized approach to re-evaluation rather than a fixed universal timeframe. Despite these considerations, there is a notable lack of high-quality comparative studies directly evaluating short-term versus conventional re-evaluation intervals following NSPT. Most available studies focus on treatment outcomes rather than the timing of reassessment itself. This creates a significant gap in the literature, particularly regarding whether earlier re-evaluation could enhance clinical decision-making, improve patient outcomes, or optimize resource utilization in clinical practice. In addition, with increasing emphasis on minimally invasive and patient-centered care, there is a growing need to refine periodontal treatment protocols to ensure efficiency without compromising effectiveness. Determining the optimal timing of re-evaluation could contribute to improved treatment planning, reduced disease progression, and enhanced long-term periodontal stability. Therefore, this study aims to address this gap by investigating the effectiveness and clinical implications of shorter re-evaluation intervals following periodontal therapy, compared to conventional timeframes.

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.

Rehabilitation of the posterior maxilla with dental implants is frequently complicated by insufficient residual bone height resulting from alveolar ridge resorption and maxillary sinus pneumatization. Lateral sinus floor elevation has become a predictable and widely accepted procedure for increasing bone volume and enabling implant placement in severely atrophic posterior maxillary sites. The long-term success of this procedure is largely dependent on the grafting material used to maintain space beneath the elevated Schneiderian membrane and promote new bone formation. Deproteinized bovine bone mineral (DBBM), commonly known as xenograft, remains the most extensively documented grafting material for sinus augmentation due to its osteoconductive properties, volumetric stability, and favorable long-term clinical outcomes. However, xenografts are characterized by slow remodeling and prolonged persistence of residual graft particles, which may delay replacement by vital bone. Consequently, strategies to enhance the biological activity of xenografts and accelerate bone regeneration have become an area of considerable research interest. Leukocyte- and platelet-rich fibrin (L-PRF) is a second-generation autologous platelet concentrate containing a fibrin matrix enriched with platelets, leukocytes, cytokines, and growth factors including platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and transforming growth factor-β (TGF-β). These biological mediators may enhance angiogenesis, accelerate wound healing, stimulate osteoblast proliferation, and improve bone regeneration. Several studies have demonstrated promising outcomes when L-PRF is used in sinus augmentation procedures. Mazor et al. reported successful bone formation and implant placement following sinus augmentation using PRF as the sole grafting material after six months of healing. Histological analysis demonstrated the formation of newly regenerated vital bone within the augmented sinus compartment. More recently, Cortellini et al. conducted a randomized controlled trial comparing L-PRF block and DBBM in lateral sinus floor elevation. Although both techniques allowed successful implant placement after six months, differences in volumetric stability and graft remodeling were observed. The authors suggested that L-PRF-containing grafts may represent a biologically active alternative capable of enhancing healing while maintaining sufficient bone volume for implant placement. Pichotano et al. further demonstrated that combining L-PRF with DBBM accelerated bone maturation and facilitated earlier implant placement when compared with xenograft alone. Histomorphometric findings revealed greater percentages of newly formed bone and reduced healing times in the L-PRF group. Despite these promising findings, the available evidence remains limited, and there is no clear consensus regarding whether the addition of L-PRF to xenografts results in clinically significant improvements in bone regeneration, volumetric maintenance, and implant site development. Therefore, a randomized controlled clinical trial comparing xenograft alone versus L-PRF block combined with xenograft during lateral sinus floor elevation is warranted.

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.

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 within the study will be 7 years.

This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.

This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http://mdstemcells.com/nest/

This study aims to evaluate the effectiveness of a Virtual Reality (VR)-based mindfulness and meditation intervention in reducing anxiety among patients undergoing fertility-related surgical procedures. Anxiety is a common challenge in fertility treatments, often leading to emotional distress and increased pain perception. By incorporating a non-invasive VR intervention, the investigators seek to improve patient experience, minimize preoperative anxiety, and potentially reduce postoperative discomfort and recovery times. This randomized controlled trial (RCT) will compare standard care with a VR intervention in a clinical setting, measuring key outcomes such as anxiety levels, pain perception, recovery duration, and overall patient satisfaction. The findings may contribute to more patient centered fertility care, offering an innovative, scalable, and cost-effective approach to anxiety management in reproductive medicine.

The investigators aim is to investigate the brain's dynamic complexity across three phases of an ovarian stimulation cycle (basal, pre-OPU, mid-luteal), to observe the impact of externally administered hormones, and compare it with the corresponding phases of a natural menstrual cycle (early follicular, pre-ovulatory, mid-luteal) in the same woman. Brain activity patterns will be examined using resting-state fMRI in a sample of young, healthy, naturally cycling women.

Women with a severely diminished ovarian reserve and monofollicular growth are at a higher risk of premature ovulation as well as poor quality oocytes. Our group showed previously that women with severely diminished ovarian reserve benefit from receiving the final oocyte maturation at smaller follicle sizes in terms of reducing the risk of premature ovulation and finding mature oocytes even out of small size follicles. Adding the measurement of the follicular volume at the time of final oocyte maturation might provide more information on the proper timing of trigger administration compared to the follicular size alone, hormonal profile as well as previous stimulation attempts. Setting a cutoff value of follicular volume for trigger might help to avoid premature ovulation and possibly increase the chances of ending up with a euploid embryo.

This study examines if monitoring serum Follicle Stimulation Hormone (FSH) levels can predict oocyte yield and progesterone levels, considering factors like age, baseline FSH, Antral Mullerian Hormone (AMH), antral follicle count, body weight, kidney function, and urinary FSH. The aim is to find a minimum FSH level that ensures optimal ovarian response and enables tailored FSH dosages for better outcomes.

It has been proposed that enriching transfer media with hyaluronan (EmbryoGlue medium) improves pregnancy outcomes compared with media containing lower concentrations of this molecule. However, none of previous studies included preimplantation genetic testing for aneuploidy (PGT-A) embryos. In order to investigate the impact of this hyaluronan-enriched on pregnancy outcomes, it is essential to evaluate its efficacy on euploid-only embryo transfers. The aim of the present study is to evaluate whether a short period of exposure of euploid blastocysts to EmbryoGlue prior to and during transfer positively impact on pregnancy outcomes of frozen embryo transfer (FET) cycles.

This study aims to explore the potential correlation between decreased ovarian reserve and previous history of early miscarriage.

To describe the peripheral serum levels of the anti-inflammatory cytokines IL-4 (Interleukin-4), IL-10 (Interleukin-10), TGF-ß1 (Transforming Growth Factor beta1), the pro-inflammatory cytokines IL-17 (Interleukin-17), IFγ (Interferon Gamma) and the immune mediator PIBF (Progesterone-Induced Blocking Factor) along a single frozen euploid blastocyst transfer in a natural cycle (NC) or Hormone Replacement Therapy (HRT).

The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes. The objectives of the Registry are: * To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention. * To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. * To characterize the Pompe disease population. * To evaluate the long-term effectiveness of alglucosidase alfa.