Tashkent

Researchers are evaluating the safety and effectiveness of the PerQdisc Nucleus Replacement Device NRD for patients with degenerative disc disease DDD causing chronic low back pain. This prospective, open-label, multi-center study involves 72 patients who have DDD in one or more lumbar discs between L1 and S1. The study aims to collect additional data on this minimally invasive device, which is designed to maintain disc height and preserve spinal motion compared to the current standard spinal fusion surgery. Participants will undergo nucleus replacement surgery using the PerQdisc device via standard anterior, lateral, or minimally invasive posterolateral surgical approaches to replace the single nucleus pulposus in the affected lumbar disc. All surgeries require approval from a Medical Advisory Board. The study focuses on patients who have exhausted at least six months of conservative treatments for their back pain and meet specific criteria, including disc height and pain scores. During the study, participants will be monitored closely with evaluations at multiple time points up to five years. Researchers will assess performance outcomes such as disability Oswestry Disability Index, pain levels Visual Analog Scale, disc height, and range of motion, as well as safety outcomes including device expulsion, failure, neurological status, revision surgeries, and serious adverse events. Follow-up visits will include questionnaires, imaging, and clinical assessments to track the devices impact over time.

Researchers are evaluating ZE94-0605, an oral selective cyclin-dependent kinase 2 CDK2 inhibitor, in adults with advanced, unresectable, or metastatic solid tumors that have not responded to or are intolerant of existing therapies. This first-in-human, open-label Phase 1 study consists of two parts Phase 1a to find the highest safe dose and biologically effective dose through sequential dose escalation, and Phase 1b to randomize participants with specific molecular features such as CCNE1 amplification to determine the recommended Phase 2 dose. ZE94-0605 is given orally once daily in a fasted state in continuous 28-day cycles. Phase 1a explores doses from 50 mg optional up to 650 mg or higher if needed, while Phase 1b randomizes about 30 participants to receive either the maximum tolerated dose or one dose level below it. Treatment continues until disease progression, unacceptable side effects, withdrawal, or completion of 26 cycles. Participants will undergo regular assessments including response evaluations before dosing on several cycle days, detailed pharmacokinetic and biomarker testing during early cycles, and circulating tumor DNA analysis at multiple timepoints. Researchers will monitor safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity. The study duration may extend up to approximately 24 months with ongoing monitoring and follow-up.

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 diagnosed 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 investigation designed to protect a damaged colon segment, such as a surgical anastomosis or a leak, from contact with fecal flow for up to 14 days after surgery. Participants will have surgery performed according to the surgeons preferred method. After the colorectal anastomosis is completed and leak testing confirms no leak, the ColoSeal ICD Device will be inserted transanally using a delivery system. The devices anchor is positioned in healthy bowel above the area needing protection. The external part of the device is secured to the skin and connected to a collection bag. The device will remain in place for about 10 days post-surgery, after which leak testing will be repeated before device removal. During the study, participants will be monitored through scheduled assessments including leak tests before device insertion and removal. Researchers will track device-related adverse events up to 90 days after the procedure, procedure success and time, device migration, occurrence of anastomotic leakage, need for ostomy surgery, and successful device removal. Follow-up visits and monitoring will ensure participant safety and data collection throughout the study period, which lasts until the study completion date in late 2026.

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 drugs 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 patients 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 childs 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 devices 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.