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NCT ID: NCT06142162 Recruiting - Sepsis Clinical Trials

To Develop an Algorithm for Predicting the Unfavorable Course of Sepsis in Children Based on a Comprehensive Assessment of Immunological, Biochemical and Molecular Genetic Markers

Start date: July 1, 2021
Phase:
Study type: Observational

Current study evaluates the relationship between cell immunity, biochemical and genetic markers in patients with sepsis in order to develop algorithm for predicting the course and outcome of severe bacterial infections.

NCT ID: NCT06112808 Recruiting - Advanced Melanoma Clinical Trials

A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

Start date: May 29, 2023
Phase: Phase 1
Study type: Interventional

The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects with advanced unresectable or metastatic melanoma of the skin. The study will have randomized, double-blind design with parallel assignment.

NCT ID: NCT05908162 Recruiting - Sepsis Clinical Trials

Algorithm for Predicting the Unfavorable Course of Sepsis in Children

Start date: July 1, 2021
Phase:
Study type: Observational

A comprehensive strategy will be used to investigate the relationship and correlation between 4 diagnostically significant markers relevant for early diagnosis and prediction of complications and death in the development of sepsis in children (C-reactive protein, procalcitonin, presepsin and lipopolysaccharide binding protein). For the first time, an attempt will be made to assess the genetic characteristics of the patient's from the point of view of predisposition to the unfavorable development of the sepsis based on the study of polymorphism of a number of genes of the immune system (tumor necrosis factor beta; interleukin 6, 8, 10; lymphotoxin alpha, etc.). Based on the study results, an algorithm to predict the unfavorable course of sepsis in children will be developed using a comprehensive assessment of biochemical and molecular genetic markers.

NCT ID: NCT05800821 Recruiting - Clinical trials for Carotid Artery Diseases

Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning

Start date: May 3, 2023
Phase:
Study type: Observational

Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical syndrome following carotid endarterectomy (CEA), but it may present in both CEA and carotid artery stenting, and is characterised by throbbing ipsilateral frontotemporal or periorbital headache, and sometimes diffuse headache, eye and face pain, vomiting, confusion, macular oedema, and visual disturbances, focal motor seizures with frequent secondary generalisation, focal neurological deficits, and intracerebral or subarachnoid haemorrhage. Knowledge of CHS among physicians is limited. Most studies report incidences of CHS of 1-3% after carotid endarterectomy. CHS is most common in patients with increases of more than 100% in perfusion compared with baseline after carotid revascularization procedures and is rare in patients with increases in perfusion less than 100% compared with baseline. The pathophysiological mechanism of CHS remains only partially understood. The chronic lowflow state induced by severe carotid disease results in a compensatory dilation of cerebral vessels distal to the stenosis, as part of the normal autoregulatory response, to maintain adequate cerebral blood flow (CBF). In this chronically dilated state, the vessels lose their ability to autoregulate vascular resistance in response to changes in blood pressure. In fact, it has been shown that this dysautoregulation is proportional to the duration and severity of chronic hypoperfusion. After revascularization and reperfusion, the impaired cerebral autoregulation could then contribute to a cascade of intracranial microcirculatory changes, as explained above, with an inability of reaction toward the augmentation of the CBF after the carotid recanalization. Although most patients have mild symptoms and signs, progression to severe and life-threatening symptoms can occur if CHS is not recognised and treated adequately. Because CHS is a diagnosis based on several non-specific signs and symptoms, patients may be misdiagnosed as having one of the better-known causes of perioperative complications like thromboembolism.

NCT ID: NCT05757089 Recruiting - Alcohol Drinking Clinical Trials

Efficacy of the Dietary Food Supplement ALCOFILTRUM in Alleviating Alcohol Hangover Symptoms

Start date: March 3, 2022
Phase: N/A
Study type: Interventional

The aim of this open-label, randomized, crossover, comparative pilot study is to assess efficacy and safety of the dietary food supplement ALCOFILTRUM in healthy volunteers who consume alcohol. Specifically the study will evaluate: - Efficacy of the intervention to alleviate hangover symptoms in participants who consumed alcohol, - Safety of intervention in participants who consuming alcohol. Participants will take four tablets of ALCOFILTRUM dietary food supplement 30 minutes before alcohol ingestion, while the control group will intake only alcohol drink.

NCT ID: NCT05751928 Recruiting - Melanoma (Skin) Clinical Trials

A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma

NEO-MIMAJOR
Start date: March 2023
Phase: Phase 3
Study type: Interventional

This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable).

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: 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: NCT05335213 Recruiting - Liver Cirrhosis Clinical Trials

Urinary Tract Infections in Cirrhosis

Start date: January 5, 2022
Phase:
Study type: Observational [Patient Registry]

Evaluate the prevalence and types of urinary tract infections, the features of the gut and urinary tract microbiota in cirrhosis, to assess its importance in the development of complications and outcomes of cirrhosis.

NCT ID: NCT05334693 Recruiting - Clinical trials for Acute Myeloid Leukemia

Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML

Start date: November 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.