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NCT ID: NCT05747261 Recruiting - Clinical trials for Spinal Muscular Atrophy (SMA)

Study of the Safety and Efficacy of an Adeno-Associated Viral Vector Carrying the SMN Gene After a Single Intravenous Administration of Escalating Doses in Children With Spinal Muscular Atrophy (BLUEBELL)

BLUEBELL
Start date: February 2, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this multicenter, open-label, non-comparative, cohort study is to investigate the safety, immunogenicity, and efficacy of ANB-004 in children with spinal muscular atrophy. The study will have a standard 3+3 dose-escalation design.

NCT ID: NCT05739695 Recruiting - Lung Cancer Clinical Trials

A Trial of Radial EBUS Versus VBN for the Peripheral Pulmonary Lesions

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Peripheral pulmonary lesions are of growing importance in respiratory field. Early detection of lung cancer, tuberculosis and other diseases often needs a bronchoscopic investigation with different types of navigation. Current randomized clinical study is intended to compare three different modalities of navigation in bronchial tree - virtual bronchoscopy (VBN), radial endobronchial ultrasound (EBUS) and combination of both techniques.

NCT ID: NCT05739474 Recruiting - Influenza Clinical Trials

Tolerability, Safety and Immunogenicity Trial of the Flu-M Tetra Vaccine in Children

Start date: January 19, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess tolerability, reactogenicity, safety and immunogenicity of the Flu-M Tetra vaccine as compared to the VaxigripTetra vaccine in terms of prevention of influenza in children aged 6 months to 17 years old inclusive.

NCT ID: NCT05734222 Recruiting - Incisional Hernia Clinical Trials

Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias

Start date: September 29, 2022
Phase: N/A
Study type: Interventional

The goal of our work of optimization of the treatment of postoperative hernias is to improve the results of treatment of patients with median and median-lateral postoperative hernias of medium (W2) and large (W3) sizes by developing new surgical techniques. The main questions it aims to answer are: 1. To study the topographic and variant anatomy of vessels and nerves in the retromuscular, preperitoneal, postperitoneal and pre-abdominal cell spaces of the anterior abdominal wall. To determine the most probable sources of blood flow and lymph from the anatomical formations forming the bed of the endoprosthesis. 2. To develop technical, surgical techniques that allow to form an implant bed with minimal traumatization of blood vessels and nerves and reduce the risk of postoperative complications. 3. To develop a technique for plasty of the anterior abdominal wall in mid-lateral postoperative hernias with a combination of retromuscular and subaponeurotic spaces. The researchers will compare an experimental group in which a new method of preparing the implant place will be used and a control group in which standard methods of treating postoperative ventral hernias were used to see whether the new method affects the improvement of the postoperative period and the reduction of complications.

NCT ID: NCT05732805 Recruiting - Melanoma Clinical Trials

A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma

OCTAVA
Start date: August 2, 2022
Phase: Phase 3
Study type: Interventional

The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.

NCT ID: NCT05730699 Recruiting - Clinical trials for Neuromyelitis Optica Spectrum Disorders

Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE)

AQUARELLE
Start date: December 12, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to study the efficacy and safety of BCD-132 (divozilimab) in subjects with neuromyelitis optica spectrum disorders (NMOSD).

NCT ID: NCT05726630 Recruiting - Clinical trials for Systemic Scleroderma

Clinical Study of Divozilimab in Patients With Systemic Scleroderma

LIBERIUS
Start date: December 26, 2022
Phase: Phase 3
Study type: Interventional

The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active systemic scleroderma according to the ACR/EULAR 2013 criteria with a modified Rodnan skin score (mRSS) of 10 to 20. In patients having signs of ILD, the Forced Vital Capacity (FVC) should be at least 40 % of the due value. Subjects will be randomized to divozilimab or placebo group.

NCT ID: NCT05717413 Recruiting - Osteoarthritis Clinical Trials

New Method of Surgical Treatment of Patients With Osteoarthritis of the 1st Metatarsophalangeal Joint

Start date: September 1, 2022
Phase:
Study type: Observational

Relevance The first metatarsophalangeal joint (MPJ) has an important function in the biomechanics of human gait, especially in the toe and thrust phases, as the full range of motion at this joint provides the body with smooth horizontal acceleration. The flattening of the arches of the foot and, as a result, the overload of its anterior section occupy a leading place in the etiology of deforming osteoarthritis (Hallux rigidus). Hallux rigidus is a disease associated with degenerative changes in the articular cartilage of the first metatarsophalangeal joint. The relevance of the treatment of arthrosis of the first metatarsophalangeal joint is determined by the high incidence and functional significance of the joint. At the 3rd and 4th degrees of arthrosis, arthrodesis, resection arthroplasty and arthroplasty of the first metatarsophalangeal joint are used. To date, the most optimal methods of surgical treatment of severe arthrosis of the first metatarsophalangeal joint are arthroplasty and arthrodesis of the joint. These operations are preferred because they achieve good clinical and radiological results. Long-term follow-up studies are needed to confirm the current findings. Uncoupled endoprostheses are characterized by satisfactory mobility, the ability to withstand high loads, and ligament structures are preserved during their implantation. Of the existing types of non-bonded endoprostheses, zirconium ceramics has a number of advantages, such as: good ingrowth ability, no wear, no rejection reactions. The main advantages of this type of surgical treatment are: rapid pain relief, improved function and stability, individual adaptation of prostheses. Endoprosthetics is recommended for patients of working age with high functional demands. Thus, the development and implementation of new design solutions in clinical practice is relevant and promising. task in the surgical treatment of patients with deforming osteoarthritis of the first metatarsophalangeal joint. Purpose of the study: To develop and introduce into clinical practice a new method of surgical treatment of patients with deforming osteoarthrosis of the first metatarsophalangeal joint using an anatomically adapted endoprosthesis.

NCT ID: NCT05715723 Recruiting - Clinical trials for Ethanol Intoxication

Study of Safety and Efficiency of the Drug Reamberin® in the Intensive Care of Patients With Acute Ethanol Intoxication

Start date: September 15, 2022
Phase:
Study type: Observational

Acute ethanol intoxication is the most frequent pathologic condition developing in subjects using alcohol. The severity of disorders in acute alcohol intoxication is determined, first of all, by the quantity of consumed alcohol and the duration of the toxic effect. When toxic doses of alcohol are taken per os, a life-threatening condition develops, which is manifested by consciousness depression and severe metabolism disorders. Reamberin (1.5 % meglumine sodium succinate solution) is an infusion solution with a balanced electrolyte composition and succinic acid, which is recommended for rehydration and detoxication in patients with intoxications of different genesis. The metabolic effect of Reamberin helps restore homeostasis and improve the natural organism detoxication. The investigators suppose that administration of Reamberin to patients with acute ethanol intoxication will make it possible to improve the treatment quality as compared to the standard therapy.

NCT ID: NCT05712291 Recruiting - Knee Osteoarthritis Clinical Trials

Optimization of Total Knee Arthroplasty Using Robotic Systems

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

For the first time, it is planned to create algorithms for working with a robotic system at different patient flow rates, optimize the use of computed tomography to assess bone density and pronounced osteophytes, develop an algorithm and tactics for treating bilateral osteoarthrosis of the knee joint using an active robotic system. Aim: optimization of total knee arthroplasty using robotic systems and improvement of treatment outcomes. Objectives: to develop algorithms for preoperative planning, surgical intervention using an active robotic system; to improve the technique of active robotic total knee arthroplasty in osteoporosis, osteosclerosis and pronounced osteophytes; to develop a tactic for the treatment of patients with bilateral osteoarthrosis of the knee joint using an active robotic system. It is planned to conduct an open-label retrospective and prospective clinical study in parallel observations.The study is planned to include 250 patients with osteoarthritis of the knee joint stage 3-4 (according to Kellgren-Lawrence). The methodology developed and improved in the dissertation will be introduced into the work of the clinical Departments of Traumatology, Orthopedics and Disaster Surgery, studying the learning curve.