Irbid

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

This research investigates the ability of Omnichroma composite restorations to match the color of tooth structure after in-office dental bleaching. It addresses the challenge that composite restorations do not lighten with bleaching like natural teeth, which can lead to replacing restorations and potentially weakening teeth. The study tests whether single-shade resin-based composites perform similarly to conventional multi-shade composites in color matching and patient and dentist satisfaction. Participants will receive in-office bleaching treatment using hydrogen peroxide 40% with either conventional multi-shade nanohybrid composite restorations or single-shade Omnichroma composite restorations. The study is randomized with two groups comparing these materials across anterior teeth. Color measurements will be taken before and after bleaching, and satisfaction will be assessed by blinded dentists and patients. During the study, patients will have their teeth and restorations evaluated with a digital spectrophotometer and subjective assessments of color match. Follow-up visits include patient satisfaction surveys two weeks post-bleaching and color measurements over one year. Dentists will also evaluate color blending. The study involves monitoring for color match and satisfaction outcomes to assess the performance of the composites after bleaching.

Researchers are evaluating how well single-shade resin-based composites RBCs match the color of natural teeth compared to conventional multi-shade composites in anterior tooth restorations. This study focuses on the aesthetic success of dental restorations by assessing the shade-matching ability, patient satisfaction, and dentist satisfaction with these materials. The trial includes 240 teeth from patients, studying different restoration types such as Class V, III, IV, and diastema closures. Participants will be divided into two groups one group will receive restorations using conventional multi-shade nanohybrid RBC, and the other will receive a single-shade composite with color adjustment potential. Each patient will have at least one tooth restored with each type, allowing a direct comparison. The study uses a double-blind design to keep both patients and clinicians unaware of which material is used. Satisfaction with color blending will be assessed one week after treatment. During the study, researchers will use a digital spectrophotometer to measure tooth color and evaluate patient and dentist satisfaction over one year. Follow-up assessments will include subjective feedback using a Visual Analogue Scale VAS. The trial aims to monitor the color adaptation of the composites and the overall aesthetic integration in the restored teeth. Participants will be observed for up to one year to evaluate the outcomes and satisfaction levels.

Researchers are evaluating the color stability and wear resistance of two types of injectable composite materials used for anterior aesthetic dental restorations. This clinical trial compares highly filled injectable flowable composite materials with preheated conventional composites to assess their performance in vivo using a randomized controlled design. The study involves 20 patients needing at least six anterior restorations each, with a total of 142 restorations assigned to two groups. One group will receive anterior teeth restorations using flowable composite veneers, while the other group will have heated composite veneers applied. Both groups will be treated using the injectable resin technique. The trial will assess these restorations at baseline, 6 months, and 12 months. Parameters evaluated include color stability using a shade guide and spectrophotometer, and wear resistance by measuring material loss through 3D laser scanning of gypsum replicas. Clinical performance will be measured by USPHS criteria. Participants will undergo evaluations at the start of the study and during follow-ups at 6 months and one year. Assessments include color matching, volumetric wear measurement, and clinical performance checks. The study tracks changes over time to compare the two composite types. The total duration of participation spans one year after the restorations, with monitoring to determine which material maintains better color and durability.

Researchers are studying the effects of topical hyaluronic acid on reducing pain and improving bone healing after the surgical removal of lower wisdom teeth. This clinical trial uses a split-mouth design, meaning each patient receives both treatments for comparison. The study will enroll 20 patients aged 18 to 35 years with specific types of impacted wisdom teeth, aiming to assess how hyaluronic acid combined with a collagen sponge affects recovery compared to collagen sponge alone. Each participant will undergo surgical extraction of both lower wisdom teeth performed by the same experienced surgeon. One extraction site will randomly receive hyaluronic acid gel with a collagen sponge, while the other site will receive only a collagen sponge. The procedure includes local anesthesia, bone removal if needed, and suturing, followed by standard postoperative care and suture removal after seven days. Pain will be recorded at 12 hours, day 3, and day 7 after surgery. Bone healing will be assessed through X-rays and tissue samples taken weeks after extraction. Participants will have their pain levels recorded using a visual scale and undergo radiographic imaging about eight weeks post-surgery to evaluate bone healing. Histological analysis of bone samples from both sockets will be done six weeks after the procedure to measure new bone formation. The study will analyze differences in pain and bone healing between the treated and control sites. The total study period includes surgery, follow-up visits, imaging, and tissue biopsy for detailed evaluation of healing.

Researchers are studying diabetic foot ulcers DFU and their related risk factors and complications among adults with diabetes mellitus DM in Northern Jordan. The study also evaluates how an educational program influences patients foot care behavior. This research aims to better understand the causes and effects of diabetic foot problems and how education may improve patient outcomes. The study has two parts. First, a cross-sectional study involved 200 diabetes patients to identify risk factors and complications of DFU. Then, a randomized clinical trial with 105 patients compared two groups one receiving standard care, and the other receiving standard care plus a formal educational session and ongoing foot care education through mobile health by a clinical pharmacist. The follow-up period for the educational intervention lasted 8 weeks. Participants will be monitored for diabetic foot care practices and medication adherence at the start and after 8 weeks. Researchers will collect demographic and clinical data to assess risk factors and complications associated with diabetic foot. The main outcomes include the number of patients with and without diabetic foot ulcers and those receiving foot care education. Safety and behavior changes will be tracked throughout the study.

This research focuses on shoulder pain that often occurs after laparoscopic gastric sleeve surgery, a common procedure for managing obesity. The study aims to compare the effects of an anesthetic plan that includes ketamine to one that does not, in order to see how they influence the incidence and severity of shoulder pain following surgery. Shoulder pain after laparoscopy is a frequent and sometimes long-lasting issue, thought to be caused by irritation of the diaphragm and nerves during the procedure. Participants will be assigned to one of two groups one will receive an intraoperative intravenous ketamine infusion at a dose of 0.3 mg per kilogram per hour as part of their anesthetic management, while the other group will not receive ketamine. The study compares these two approaches to see if ketamine reduces shoulder pain after surgery. The trial is randomized and uses quadruple masking to ensure unbiased results. During the study, participants will be monitored for pain levels using the Visual Analog Scale VAS and the COMFORT scale over a period of six months. Researchers will also observe recovery duration, hospital stay length, post-operative pain medication needs, side effects from ketamine, and nausea or vomiting after surgery. The total follow-up period extends to six months to assess these outcomes thoroughly.

Researchers are evaluating the long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia HeFH or HoFH. This open-label, single-arm, multicenter extension study includes participants who have completed prior pediatric ORION studies ORION-16, ORION-13, ORION-20, or ORION-19. The trial aims to provide continued access to inclisiran treatment while monitoring safety outcomes over an extended period. Participants receive inclisiran injections, with dosing based on their previous study participation and weight. Those from ORION-16 or ORION-13 receive a 300 mg dose equivalent to 284 mg inclisiran in a 1.5 mL solution. Participants from ORION-19 and ORION-20 receive weight-based dosing. The study allows ongoing treatment with inclisiran to assess long-term effects and tolerability. During the study, participants are monitored for treatment-emergent adverse events and serious adverse events from day one through up to 1080 days. Researchers also measure changes in LDL cholesterol levels from the baseline of the prior studies to the end of this extension. The involvement includes regular safety assessments and evaluations to ensure participant well-being throughout the study duration, which may last nearly three years.

Researchers are studying the safety, effectiveness, and how the body processes Vibegron in children aged 2 to less than 18 years who have neurogenic detrusor overactivity NDO and regularly use clean intermittent catheterization CIC. This open-label trial aims to better understand Vibegrons impact on this pediatric population over a long-term period. Participants receive Vibegron orally once daily, with doses adjusted based on their weight. The study has two parts Part A where doses may be reduced up to two times based on individual responses and safety, and Part B where participants receive a dose selected by a safety monitoring board based on data from Part A. Participants are grouped into cohorts according to weight ranges. Throughout the study, participants undergo assessments including bladder function tests and questionnaires measuring incontinence and symptom severity. Researchers monitor changes in bladder capacity, detrusor activity, catheterized volumes, leakage episodes, and quality of life over approximately 52 weeks. Safety and drug processing are continuously evaluated, with the study expected to complete around September 2030.