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NCT ID: NCT06365593 Recruiting - Clinical trials for Hereditary Transthyretin Amyloidosis

hATTR Polyneuropathy in Russia

PRIMER
Start date: December 29, 2023
Phase:
Study type: Observational

A multicenter observational retrosPective Registry of patIents with transthyretin aMyloid polynEuropathy (hATTR-PN) and chRonic idiopathic axonal polyneuropathy (CIAP) in the population of the Russian Federation (PRIMER) There are no comprehensive epidemiological data on patients with hereditary ATTR-PN (hATTR-PN) and CIAP in the Russian Federation. Therefore, there is a need to conduct a large-scale observational study in the Russian population to obtain information on clinical, electrophysiological and demographic characteristics of patients with hATTR-PN and CIAP. Obtaining the study data will help to identify the patients with axonal polyneuropathy, who deserve TTR gene sequencing, and therefore to allow early treatment and potentially modify disease progression in patients.

NCT ID: NCT06365307 Recruiting - Spinal Stenosis Clinical Trials

Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion

Start date: November 13, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion prosedure in comparison with bone autografts and synthetic material based on β-TCP

NCT ID: NCT06362746 Recruiting - Pulmonary Embolism Clinical Trials

Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism

Start date: May 23, 2024
Phase: Phase 3
Study type: Interventional

Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE)

NCT ID: NCT06362694 Recruiting - Clinical trials for Anaplastic Thyroid Cancer

Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy

Start date: March 25, 2024
Phase: Phase 2
Study type: Interventional

This pilot phase 2 study evaluates the effectiveness and safety of the Rechallenge concept in patients with BRAF-positive anaplastic thyroid cancer after progression on anti-BRAF therapy. Patients with BRAF-positive anaplastic thyroid cancer who were previously treated with dabrafenib and trametinib (with a clinical or objective response at the start of treatment) and later with tumor progression during anti-BRAF therapy and subsequent lines of chemotherapy are scheduled to undergo targeted therapy (repeated administration of dabrafenib and trametinib in standard doses) and evaluate the outcomes according to the primary and secondary endpoints.

NCT ID: NCT06361264 Recruiting - Clinical trials for Stage IV Breast Cancer

Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide

Start date: November 1, 2018
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to evaluate the safety and clinical efficacy of personalized chemotherapy with low doses of cyclophosphamide administered taking into account the reparative cycle of tumor cells in participants with breast cancer (stage IV or disease progression). The main question it aims to answer is: Does personalized chemotherapy of breast cancer with low doses of cyclophosphamide, taking into account the reparative cycle of tumor cells, lead to a significant reduction in tumor size and improvement in the visual status of controlled tumor foci relative to their initial state? During the preparatory stage, a tumor sample from participant is harvested intraoperatively. The primary culture is obtained from this tumor tissue sample. Repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle G2/M phase is identified. The schedule of administering cyclophosphamide and DNAmix complex composite preparation is calculated according to the resulting time points. According to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days.

NCT ID: NCT06357936 Not yet recruiting - Limb Ischemia Clinical Trials

Nanofat Grafting as a Method of Treating Critical Limb Ischemia

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

This clinical trial will investigate nano fat grafting as a method for treating critical limb ischemia. The method involves the collection of adipose tissue under tumescent anesthesia through a separate incision in the anterior abdominal wall, followed by preparation and injection of nano fat into the tissues of the foot and leg without additional drug therapy. The novelty of this method lies in the use of autologous stem cells and growth factors, differing from current treatments like neovasculgen, which is a plasmid DNA-based treatment. The trial aims to assess the safety and effectiveness of nano fat grafting, including pain relief, the frequency of intraoperative complications, increased distance of pain-free walking, limb preservation, and mortality rates. The trial will involve patients with diagnosed occlusive lesions of the femoral-popliteal-tibial segment and chronic ischemia of III-IV degree according to Fontaine and 5-6 categories according to Rutherford, excluding those with contraindications for surgical intervention on the femoral-popliteal-tibial segment, chronic heart failure of III-IV NYHA class, severe liver or kidney failure, among others. The study design includes preoperative examinations, hospital phase activities including the surgery and post-operative assessments, and follow-up visits at 6 and 12 months post-operation to evaluate the method's safety, complications, and effectiveness based on various parameters like pain, trophic disturbances, and limb ischemia severity. Statistical methods will involve quantitative data presented as mean ± standard deviation, with qualitative traits compared using the Chi-square test or Fisher's exact test. The planned patient number is 40, aiming to demonstrate the effectiveness and safety of nano fat grafting for critical limb ischemia treatment compared to current treatments.

NCT ID: NCT06355921 Not yet recruiting - Desmoid Tumor Clinical Trials

A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors

RFAdesmoid
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors. In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month. In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months.

NCT ID: NCT06349187 Recruiting - Clinical trials for Emotional Intelligence

Digital Literacy and Emotional Intelligence and Professional Burnout Among Doctors

Start date: April 10, 2024
Phase:
Study type: Observational

The role of digital technologies in healthcare is growing. Therefore, the roles and responsibilities of medical professionals are constantly changing and there is a need for continuous professional development. However, according to some authors, today's generation of doctors can be considered as "digital aborigines" [Aungst, Patel, 2020]. Low literacy in the field of e-health has become a major obstacle to digital transformation in developed countries, so digital skills training for healthcare professionals has gradually been introduced in the USA [Adler-Milstein, et al., 2014], Europe [Schreiweis, et al., 2019], Australia [Evolution of eHealth in Australia, 2016]. However, in our opinion, the digital competence of a doctor is not only the ability to work at a computer and use software. The successful development of the digital world is preceded by some psychological and emotional processes. Computerization and automation of the healthcare system began relatively recently, traditional (paper) document management in medicine is familiar to everyone, but not optimal from the point of view of system management. Therefore, universal digitalization is perceived as something artificially imposed, increasing the workload of doctors, distracting from their main work and shifting the focus from truly therapeutic activities to filling out documentation. As a result, doctors have a range of negative emotions: fear, annoyance, anxiety, despondency, refusal of further contacts, etc., which lead to an aggravation of emotional burnout. The ability to recognize and live through these states, to come to an inner balance, to accumulate an internal resource for further development of new technologies - all this is possible under the condition of the development of emotional intelligence. By developing so-called soft skills, the doctor will be emotionally stable, capable of further advancement and learning new skills, and will easily cope with temporary difficulties and setbacks. And the final stage, having gained the opportunity to overcome internal obstacles, the doctor is ready to begin mastering specialized digital skills directly related to medical activities: work in medical information systems, remote monitoring, artificial intelligence, medical decision support systems. The result of the development of a doctor within this model will be not only digital literacy, but also the development of an internally stable personality that easily overcomes any obstacles not only in training, but also in communication with patients and colleagues.

NCT ID: NCT06344104 Recruiting - Clinical trials for Resistant Hypertension

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

BaxAsia
Start date: April 8, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of baxdrostat in Asian participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

NCT ID: NCT06342804 Recruiting - Cholecystitis Clinical Trials

Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg

Start date: March 19, 2024
Phase: Phase 1
Study type: Interventional

Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets). Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).