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NCT ID: NCT06425978 Not yet recruiting - Clinical trials for Genitourinary Syndrome of Menopause

Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit

CellularMatrix
Start date: May 30, 2024
Phase: Phase 4
Study type: Interventional

This study is a randomized, controlled, non-inferiority trial, that will be performed on 192 women on Menopause (absence of menstruation for at least 12 months), with diagnostic of genitourinary syndrome of menopause (SGM) and a vaginal health index <15 points, that are sexually active. Patients will be randomized 1:1, equal number assigned to each of the two treatment groups, to receive treatment with two dose of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) separated for a month, and control group that will receive the standard treatment for SGM, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel). Both groups will be follow-up for 3 and 6 month afther treatment, a blind observer will assess the application of the validated scale (VHIS, VHI), and the investigators will do the FSD, symptom record, maturation index, follow-up photography and evaluation of adverse events and treatment compliance and adherence.

NCT ID: NCT06425809 Not yet recruiting - Sport Injury Clinical Trials

Predictors of Muscle Injury Risk in Non-professional Football Players

Start date: May 20, 2024
Phase:
Study type: Observational

Background. Football accounts for 30% of all sports injuries. Muscle injuries in football are the most common non-traumatic and non-contact injuries. A comprehensive approach to injury prevention must consider the design of the footwear and the environmental conditions in which the match is played. Objective. To assess the risk of injury as a function of footwear and field of play in non-professional football players and to identify the best predictive model of muscle injury in these athletes. Method. Ambispective cohort study. Ninety-seven players will be recruited. The primary variable will be the number of lower limb muscle injuries in the last 3 seasons. Secondary and modifying variables will be: age, body mass index, boot type, pitch turf, training load and field position. Potential confounding variables will be motivation for choice of footwear, date of muscle injuries, time playing in the category and presence in the starting team. The analysis will calculate the risk of adverse effects in these patients and assess the influence of confounders and trend analysis on the primary variable, stratified by potential confounders. Expected outcomes. To calculate the risk of muscle injury as a function of anthropometric variables, and footwear and turf type. To identify the predictive model of muscle injuries in football players.

NCT ID: NCT06425666 Not yet recruiting - Cataract Surgery Clinical Trials

Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy

Start date: June 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether there is a difference in best spectacle corrected visual acuity (BSCVA) in patients treated with one of the following two surgeries: (1) cataract surgery with preservation of the diseased endothelial cells ("cataract surgery only experimental intervention, investigational therapy/ arm 1); (2) cataract surgery combined with removal of the diseased endothelial cells and the attached Descemet's membrane followed by transplantation of a healthy endothelial cell layer with attached Descemet's membrane ("triple-DMEK"(""cataract surgery only", control intervention comparator therapy/ arm 2)

NCT ID: NCT06425302 Not yet recruiting - Clinical trials for Lymphoma, Follicular

A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

GOLSEEK-2
Start date: August 3, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).

NCT ID: NCT06423898 Not yet recruiting - Clinical trials for Endocarditis, Infective

Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.

DOBLEI
Start date: September 30, 2024
Phase: Phase 4
Study type: Interventional

Phase IV, open-label, randomized and multicenter clinical trial to prove that patients with Enterococcus faecalis infective endocarditis treated with an antibiotic treatment as a continuous infusion is non-inferior to the standard intermittent infusion regimen, usually administered in hospitalized patients.

NCT ID: NCT06423690 Not yet recruiting - Lung Cancer Clinical Trials

First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System

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

A Prospective, open label, multi center, single arm, First in Human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumor resection

NCT ID: NCT06423196 Not yet recruiting - Clinical trials for Sports Physical Therapy

Upper Limb Blood Flow Restriction in Handball Players

Start date: May 19, 2024
Phase: N/A
Study type: Interventional

Introduction. Blood flow restriction therapy involves the use of an occlusion cuff placed over an extremity resulting in a partial reduction of arterial blood flow and total restriction of venous return. Objectives. To analyse the efficacy of a physiotherapy intervention using blood flow restriction in improving upper limb strength in adult handball players. Methods. Randomised, single-blind, clinical study. 20 athletes will be recruited and randomly assigned to the experimental and control groups. The intervention of the experimental group will consist of performing an exercise protocol after blood flow restriction. The intervention period will last 4 weeks, with a periodicity of 2 weekly sessions of 30 minutes each. The primary variable will be the strength of the triceps, epicondyle and epitrochlear musculature (pressure hand dynamometer). The secondary variable will be the muscle activation of this musculature (surface electromyography).

NCT ID: NCT06423157 Not yet recruiting - Clinical trials for Sports Physical Therapy

Plyometric and Stability Exercise Protocol in Female Basketball Players

Start date: May 19, 2024
Phase: N/A
Study type: Interventional

Introduction. Basketball is a high intensity intermittent sport, requiring jumping, running, accelerations and decelerations with changes of direction and lateral movements. Plyometric exercises are a training technique that consists of a cycle of muscle stretching and shortening in which the energy stored in the eccentric phase (lengthening) is released facilitating the production of maximum power in the concentric phase (shortening). Objective. To analyse the efficacy of a physiotherapy intervention through a protocol of plyometric and stability exercises in the improvement of vertical jump, stability, flexibility and agility in federated female basketball players. The primary variable will be the vertical jump (My jump 2.0). Secondary variables will be stability (Y balance test), flexibility (Sit and Reach) and agility (T-Test). Methods. Controlled, single-blind clinical study. 20 athletes will be randomised to the experimental and control groups. The intervention of the experimental group will consist of a protocol using plyometric and stability exercises. The athletes included in the control group will not perform any intervention and will continue with their usual routine. The intervention period will last 6 weeks, with a periodicity of 2 weekly sessions of 20 minutes each.

NCT ID: NCT06422975 Not yet recruiting - Shock Clinical Trials

Registry of Patients in Shock Treated With Vasopressin

Start date: June 2024
Phase:
Study type: Observational [Patient Registry]

Arginine-vasopressin (AVP) is a non-catecholaminergic hormone produced in the hypothalamus and released into the circulation via the neurohypophysis. It has different actions depending on the receptors through which it acts: V1 (vasoconstriction, platelet aggregation, efferent arteriole constriction of the renal glomerulus, glycogenolysis); V2 (water reabsorption, release of von Willebrand factor and factor VIII); V3 (increased cortisol and insulin). Septic shock is the most common cause of vasoplegic shock and its management includes control of the focus, early antibiotic therapy, volume resuscitation, vasopressor therapy, support of various organ dysfunctions, as well as monitoring and follow-up. The Surviving Sepsis Campaign (a global initiative to improve sepsis management) recommends noradrenaline as the first line of vasopressor therapy and early addition of AVP as a second line rather than further up-titration of noradrenaline when signs of hypoperfusion persist, through its action primarily on V1. The rationale for its use in septic shock would be: - endogenous vasopressin deficiency present in septic shock; - as a catecholamine-sparing strategy, reducing the side effects of catecholamines; - its potential nephroprotective effect; - its use should be early. The uncertainties surrounding the use of AVP in septic shock and other types of shock are many, hence the need for this registry.

NCT ID: NCT06422741 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers

CIRCAFENOL
Start date: May 2024
Phase: N/A
Study type: Interventional

The physiological processes of the body present daily oscillations called circadian rhythm. The circadian rhythm is essential for maintaining the vital functions of organisms, intervening directly and indirectly in a multitude of key processes, such as hormone secretion, cycles of activity and rest throughout the day, body temperature, the metabolism or absorption, processing and detoxification of nutrients. There are factors such as certain work schedules, prolonged exposure to screens, certain eating patterns or social jetlag, which have a negative impact on the circadian rhythm, causing its disruption and favoring the appearance of health alterations. Thus, there is evidence that associates night shift work with a higher incidence of risk factors for developing metabolic syndrome and cardiovascular diseases, including obesity, elevated blood levels of glucose, triglycerides, and low-density lipoprotein cholesterol (LDL-C), as well as lower levels of high-density lipoprotein cholesterol (HDL-C). In addition, disorders in the sleep cycle are associated with the development of hypertension and type 2 diabetes. Several previous studies show that a grape seed proanthocyanidin extract (GSPE) has beneficial effects on different parameters by restoring the circadian rhythm.