Amman

Researchers are studying an experimental combination of two drugs called pozelimab and cemdisiran for adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. The study aims to evaluate the long-term safety and effectiveness of this drug combination. It also investigates how the drugs behave in the body, possible side effects, and whether the body might develop antibodies against them that could affect treatment. Participants in this Phase 3 open-label extension study receive pozelimab and cemdisiran according to the study protocol. The study includes people who completed a parent study or those with a specific genetic variation (C5 polymorphism) making them resistant to certain other treatments. Treatments are administered as directed, and meningococcal vaccinations are required as part of the protocol. During the study, participants will attend clinic visits for various assessments, including safety monitoring for serious and special side effects up to week 108, and blood tests to measure changes in lactate dehydrogenase (LDH) levels up to week 36. Researchers will track adverse events, treatment tolerance, and collect data on drug levels and antibody formation. The total study duration covers long-term follow-up to better understand the treatment's effects and safety.

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 studying the safety and effectiveness of long-acting antibodies given alone or in combinations to adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter platform trial aims to find treatments that can improve symptoms and induce remission in people diagnosed with UC for at least 3 months. The study includes participants with active disease confirmed by endoscopy and histology and with moderate to severe symptoms based on a scoring system. The trial has two parts. Part A is an open-label phase testing three different monotherapy drugs to assess safety and initial effectiveness. Part B will be a randomized, placebo-controlled phase where participants receive one of six interventions (three monotherapies or three combinations) or placebo to compare outcomes. Treatments involve intravenous (IV) induction followed by subcutaneous (SC) maintenance dosing. Different treatment arms may start and finish at varying times during the study. Participants will undergo endoscopy and histology to confirm disease activity at screening, with regular monitoring throughout the study. Researchers will evaluate changes in disease severity using the Robarts Histopathology Index and measure the percentage of participants achieving clinical remission by Week 12. Safety and efficacy will be closely followed during and after treatment. The total study duration depends on treatment arm timelines and follow-up requirements.

Researchers are evaluating the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

Researchers are evaluating the efficacy and safety of inavolisib combined with Phesgo compared to placebo with Phesgo as maintenance therapy in participants who have previously untreated HER2-positive advanced breast cancer with PIK3CA mutations. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on participants with locally advanced or metastatic breast cancer, aiming to understand the treatment impact after initial induction therapy. Participants will receive inavolisib orally once daily on Days 1 to 21 of each 21-day cycle, starting on Day 1 of Cycle 1 during maintenance treatment. Phesgo will be administered subcutaneously every three weeks on Day 1 of each cycle. The study includes an induction therapy phase where taxane-based chemotherapy is given after Phesgo. Optional endocrine therapy such as tamoxifen, aromatase inhibitors, or fulvestrant may be used based on the investigator's choice, with luteinizing hormone-releasing hormone agonists administered according to local guidelines. During the study, participants will be monitored for progression-free survival for up to approximately 40 months. Assessments include evaluation of heart function, organ function, and overall health status. Researchers will track the safety and effectiveness of the treatment combination through regular clinical evaluations and laboratory tests. The total duration includes maintenance treatment cycles and follow-up to measure outcomes and monitor safety.

Autism spectrum disorders (ASDs) involve ongoing challenges in social communication and interaction as well as repetitive behaviors and restricted interests. These complex neurodevelopmental conditions also show inflammatory and immune system dysfunction. Researchers are exploring cell-based therapies as a potential treatment due to the underlying neurobiological changes in ASD, and stem cells are being considered because of their unique immune-related properties. Participants in this study receive three intravenous doses of allogeneic Wharton Jelly Mesenchymal Stromal Cells (WJMSC) at 1 million cells per kilogram every two weeks. This treatment is being evaluated to assess its safety and potential effects in children with ASD. The study is conducted in a phase 1 setting focusing on safety and tolerability. During the 12-month follow-up period, participants will undergo laboratory tests to monitor safety. Researchers will track the safety profile through these tests to better understand the impact of the treatment over time. The study enrolls children aged 4 to 14 years and involves careful dosing and follow-up to ensure adherence and participant safety.

Researchers are evaluating whether an Artificial Intelligence (AI) based computer program can automate two important parts of the radiotherapy treatment process for cancer patients. This includes outlining anatomical areas at risk of tumor spread and radiation damage, and defining the position, size, and shape of radiation beams. The study focuses on patients with cervical, head and neck, and prostate cancers who are receiving radical radiotherapy. The AI program works by uploading the patient's CT scan to a web-based system called the Radiotherapy Planning Assistant. This system automatically contours the targeted organs and areas at high risk and plans the radiotherapy beams. However, in this study, patients will receive the manual treatment plans created by local medical teams, not the AI-generated plans. The AI-generated plans will be evaluated for quality and clinical acceptability before treatment. Participants will have their radiotherapy treatment plans reviewed to see if the contours and dosimetry meet predefined clinical standards before starting treatment. The study measures how well the AI plans meet these criteria compared to standard human-made plans. Participants must be adults with confirmed cancer types and consent to radical radiotherapy. The study also involves clinical peer review of the plans to ensure safety and effectiveness.

Researchers are evaluating the use of allogenic dentin grafts derived from human-extracted teeth to preserve the alveolar ridge after tooth extraction. This prospective clinical trial focuses on the effectiveness and safety of two types of allogenic dentin grafts: demineralized dentin allografts (DDA) and whole tooth allografts (WTA). The study aims to address the limitations of autogenous bone grafts, which can cause donor site problems and may not provide enough graft material, offering a sustainable alternative that reuses extracted teeth typically discarded as waste. The study involves preparing and applying these two types of dentin allografts to patients undergoing tooth extraction. Participants will receive either DDA or WTA to support alveolar ridge preservation, which is critical for future prosthetic dental treatments such as implants and dentures. The trial is conducted in phases 1 and 2, assessing these grafts as biological treatments that could offer a scalable and effective option for bone regeneration after extraction. Participants aged 18 to 60 who need extraction of at least three teeth will be involved in follow-up assessments. Researchers will measure changes in alveolar ridge width and height using CBCT scans three months after extraction. The study also includes clinical and radiographic evaluations to monitor bone healing and graft biocompatibility. Safety will be ensured through careful screening of donors and recipients, and participants will be followed to assess the grafts' impact on bone preservation and readiness for prosthetic rehabilitation.

Researchers are evaluating the relationship between obstructive sleep apnea (OSA), facial pigmentation, vasovagal symptoms, and smoking habits in patients referred for sleep studies. This prospective cohort study aims to gather demographic and clinical information, assess facial discoloration as a potential marker for OSA, and investigate how OSA relates to vasovagal symptoms and smoking tendencies. The study also examines the timing of OSA symptom appearance in relation to smoking initiation and the effects of treatment on these conditions. Participants undergo either in-lab polysomnography at Jordan University Hospital or an at-home sleep study using a home sleep study device. Their faces are examined and photographed with consent to grade facial discoloration severity. After sleep study results, patients with positive OSA diagnoses are followed up at 3 weeks and 6 months to monitor treatment type, symptom improvement, and changes in smoking and vasovagal symptoms. Those with negative results are also followed up to track any changes in smoking and vasovagal symptoms. During the study, participants provide detailed histories about smoking, vasovagal symptoms, and sleep habits. Researchers analyze the correlation between OSA severity, facial pigmentation, and vasovagal symptoms using statistical methods. Follow-up assessments include questionnaires and interviews conducted in person, by phone, or email. The study's duration includes initial assessment plus follow-ups at 3 weeks and 6 months, focusing on treatment effects and behavioral changes related to smoking and vasovagal symptoms.

Researchers are investigating the combined effect of sensory-motor integration on balance improvement and pain reduction in women with postmenopausal peripheral neuropathy, specifically sensory-motor axonal neuropathy. This study focuses on postmenopausal women aged 45 to 55 years who have type II diabetes mellitus and experience numbness in their upper and lower limbs for over four months. Participants will be divided into groups receiving either sensory-motor integration therapy, which includes pelvic rocking training and strengthening exercises, or traditional conventional exercises. These interventions aim to evaluate their impact on improving balance and reducing pain over a six-week period. During the study, participants will be monitored and assessed for changes in pain intensity and balance after six weeks of treatment. Researchers will use these measurements to understand how the therapies affect sensory-motor integration and neuropathy symptoms in the target population.