Tashkent

Researchers are evaluating the PerQdisc Nucleus Replacement System in patients with degenerative disc disease (DDD) affecting one or more lumbar discs. This prospective, open-label, multi-center study aims to collect additional safety and effectiveness data for this minimally invasive device. The PerQdisc is designed to replace the nucleus pulposus in lumbar discs between L1 and S1, offering an alternative to spinal fusion surgery by aiming to preserve disc height and maintain spinal motion to reduce chronic low back pain. The study involves surgical implantation of the PerQdisc device using standard anterior, lateral, or minimally invasive posterolateral approaches. All patients who meet inclusion criteria and have no exclusions will be considered for nucleus replacement surgery following review by a Medical Advisory Board. The device replaces the disc nucleus at a single level of the lumbar spine, intending to preserve spinal movement and reduce pain. Participants will be monitored for safety and performance outcomes over time, including pain and disability scores at 6 and 12 months. Researchers will assess device expulsion, failure, revision surgeries, disc height, range of motion, neurological status, analgesic use, and serious adverse events up to 5 years after surgery. The study includes clinical evaluations, imaging, and questionnaires to track progress and safety, with total follow-up extending to 5 years post-implantation.

Researchers are conducting a Phase 3 global clinical trial to evaluate the safety and effectiveness of brelovitug (BJT-778) in treating chronic hepatitis delta virus (HDV) infection. This study compares brelovitug treatment to delayed treatment to understand its impact on viral response and liver enzyme normalization. The trial is randomized, open-label, and involves multiple centers worldwide. The trial includes three treatment groups. One group receives brelovitug 300 mg by subcutaneous injection once weekly for 96 weeks. Another group receives brelovitug 900 mg by subcutaneous injection once every 4 weeks with a loading dose at Week 2 for the same duration. The third group delays brelovitug treatment for 12 weeks, then receives 300 mg weekly injections for 96 weeks. Participants will attend clinic visits for treatment and monitoring over the study period. Researchers will assess viral response using HDV RNA levels, liver enzyme (ALT) normalization, and other liver health measures. Safety will be monitored through adverse event tracking up to 96 weeks. The primary outcome is the percentage of participants achieving combined viral and ALT response at Week 24 compared to delayed treatment at Week 12. Follow-up includes liver stiffness and disease progression assessments.

Researchers are evaluating ways to improve surgical treatment outcomes for liver echinococcosis complicated by biliary fistulas. The study aims to optimize diagnostic methods for early detection of biliary fistulas and improve surgical techniques to better eliminate these complications. This research focuses on refining both the diagnosis and treatment approaches to enhance patient recovery and reduce postoperative issues. The study involves conservative surgical treatment for liver echinococcosis where occult biliary fistulas are identified and managed by applying a U-shaped suture followed by medical cyanoacrylate glue between suture stitches on the fibrous capsule near the fistula. This method is being assessed to determine its effectiveness in managing biliary fistulas during surgery. Participants will be monitored for up to three months after surgery. Researchers will measure the incidence of bile leakage, the time it takes for biliary fistulas to close, treatment costs, and patients' quality of life after surgery. Detailed postoperative data including patient condition, discharge characteristics, complications, and hospital stay duration will be collected to evaluate outcomes and recovery progress.

This research aims to evaluate the safety and feasibility of the ColoSeal ICD System in adult patients with rectal and rectosigmoid cancer who are undergoing surgery to remove part of the colon and create a colorectal anastomosis. The study is a prospective, multicenter, single-arm clinical investigation focusing on protecting damaged colon segments, such as surgical anastomoses or leaks, from contact with fecal flow for up to 21 days. Participants will have scheduled colon resection surgery using the surgeon's preferred method. After completing the anastomosis and confirming no leaks, the ColoSeal ICD Device will be inserted transanally and positioned with an anchoring portion placed in healthy bowel above the site needing protection. The device will remain in place for about 10 days, secured externally with adhesive dressings, and removed after confirming no anastomotic leaks. During the study, participants will be monitored through various assessments including leak tests before device insertion and removal. Researchers will track device-related adverse events up to 90 days post-procedure and measure procedure success, procedure time, device migration, occurrence of anastomotic leaks, need for ostomy surgery, and successful device removal. The study duration includes follow-up for up to 90 days after the procedure to ensure safety and device feasibility.

This research aims to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, focusing on frequently ill children up to age 15. It investigates common congenital diseases, bronchopulmonary and cardiovascular conditions, and evaluates current treatment methods to develop improved therapies and rehabilitation approaches. The study is an early phase 1 clinical trial sponsored by Tashkent State Medical University. The study includes several stages: initially identifying commonly encountered diseases through clinical and laboratory examinations; then assessing effectiveness of standard treatments; followed by developing and applying new treatment tactics approved by an ethics committee. During the rehabilitation phase, microelements and vitamins may be added alongside physiotherapy. The final stage involves creating clinical recommendations for doctors based on research findings. Participants will undergo thorough assessments including medical history collection, physical exams, consultations with specialists, and various laboratory and instrumental tests such as blood and urine analyses, X-rays, ultrasounds, and immunological studies. Quality of life will be evaluated using standardized questionnaires. The study involves long-term monitoring over several years, working with archival data, patient grouping for immunity studies, and clinical trial evaluations to measure outcomes and safety.

Researchers are evaluating Ratutrelvir (83-0060), a drug that inhibits the main protease of SARS-CoV-2, along with Paxlovid (Nirmatrelvir plus Ritonavir), to understand their safety and effectiveness in adults with mild to moderate COVID-19 who are not hospitalized. This open-label, randomized Phase 2a study aims to determine a safe and effective dose of Ratutrelvir and compare it with standard care, providing important information on how these treatments may help manage COVID-19 symptoms and recovery. Participants will be assigned to receive either Ratutrelvir or Paxlovid alongside standard care. The study is multicenter and open-label, meaning both researchers and participants know which treatment is given. The trial includes an experimental group receiving Ratutrelvir, a comparator group receiving Paxlovid, and a non-randomized group receiving Ratutrelvir. Treatment is given during the study period, and the research team monitors the drug's concentration in the blood to understand how it behaves in the body. During the 28-day study period, participants will be closely monitored for safety based on the occurrence and severity of any adverse events. The team will assess how long it takes for COVID-19 symptoms to improve and recover fully. Blood samples will be collected up to day 11 to analyze drug levels. Participants will undergo symptom evaluations regularly, and their health will be tracked throughout the study to ensure safety and gather data on treatment effects.

This research aims to evaluate the effectiveness and safety of the Allay4 Aortic Stent as an additional endovascular treatment for patients with Type B aortic dissection who are eligible for thoracic endovascular aortic repair using stent grafts. The study focuses on reducing late complications such as aortic growth requiring reintervention or rupture. It is a prospective, multicenter, open-label clinical trial designed to assess this investigational device alongside standard care. The treatment involves first placing a covered thoracic stent graft in the descending thoracic aorta above the celiac trunk, following standard care procedures. Subsequently, the Allay4 Aortic Stent is implanted from within the stent graft and extends below the celiac trunk to the end of the dissected aorta, usually reaching the aortoiliac bifurcation. This combined approach aims to improve outcomes for patients undergoing thoracic endovascular repair. Participants will undergo assessments including imaging by CT scans at various time points up to 60 months to evaluate aortic growth, device performance, and adverse events. Researchers will monitor freedom from aortic growth requiring reintervention or rupture at 12 months as the primary outcome, along with major adverse events within 30 days post-implantation. Long-term follow-up visits will assess mortality, reintervention, device patency, and complications, with participant involvement lasting several years for comprehensive safety and effectiveness monitoring.

This research evaluates surgical methods for treating distal hypospadias, a common condition in boys where the urethral opening is on the underside of the penis. The study compares the standard graft-augmented tubularized incised plate (G-TIP) urethroplasty with a newer approach using fibrin-enhanced TIP (F-TIP) that applies the patient's own platelet-rich fibrin (PRF) during surgery. The goal is to see if PRF reduces complications like urethrocutaneous fistula and narrowing of the urethral opening after surgery. Participants are male children aged 6 months to 7 years with primary or redo distal hypospadias and an unfavorable urethral plate. They will be randomly assigned to receive either F-TIP urethroplasty with PRF applied to the incised urethral plate or standard G-TIP urethroplasty without PRF. The PRF is prepared during surgery from the child's own blood using a specific centrifugation process and fixed in place before tubularization. After surgery, children will be monitored for complications, urinary function, and cosmetic outcomes over six months. Researchers will assess the occurrence of urethral complications, urethral narrowing, urinary flow rates, and cosmetic appearance using standardized scoring. The study is conducted at multiple centers and aims to provide clearer information on which surgical approach may improve healing and results in boys with this condition.

Researchers are evaluating the safety and feasibility of the A3-Shield implant in adults with small, asymptomatic infrarenal abdominal aortic aneurysms. This trial addresses the lack of treatments that prevent the growth of small abdominal aortic aneurysms, which often enlarge over time and may require risky surgical repair. The study focuses on whether the A3-Shield device can mechanically stabilize the aneurysm neck and reduce harmful pulse wave forces that contribute to aneurysm enlargement. Participants receive a catheter-based implantation of the A3-Shield device guided by fluoroscopy. After the procedure, they attend scheduled follow-up visits which include clinical exams and imaging tests like ultrasound and computed tomography. This trial does not include randomization or a control group and aims to gather early data on the device's performance and safety. During the study, participants will undergo assessments of safety outcomes including major adverse events within 30 days and longer-term safety up to 24 months. Effectiveness measures such as successful aneurysm treatment, aneurysm size stability or shrinkage, and immobilization of the aneurysm neck are evaluated at multiple time points. Participants must be able to return for follow-up visits, and the total study duration includes assessments up to two years after implantation.

Researchers are studying echinococcosis affecting the liver, specifically investigating the presence of germinal elements such as protoscolexes and acephalocysts in the liver tissue near and within the fibrous capsule of hydatid cysts. This observational study aims to better understand the characteristics of liver echinococcosis during organ-preserving surgery. The study is sponsored by the Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov. Participants undergo echinococcectomy, a surgical procedure to remove echinococcal cysts from the liver. During surgery, samples of the fibrous capsule and adjacent liver tissue are collected for detailed pathological analysis to detect viable germinal elements. The study focuses on cysts larger than 5 cm in diameter and includes cases of both primary and recurrent liver echinococcosis requiring surgery. Participants will be monitored for the presence of viable germinal elements one day after surgery and followed for one year to check for recurrence of liver echinococcosis. The study involves intraoperative tissue sampling and subsequent pathomorphological analysis. Overall, the trial duration includes the surgery day plus a one-year follow-up period to assess outcomes.