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NCT ID: NCT06108505 Active, not recruiting - Cholesterol Levels Clinical Trials

A Clinical Study on the Effectiveness of a Lacticaseibacillus Strain on Blood Cholesterol Levels

Start date: December 4, 2022
Phase: N/A
Study type: Interventional

This is a 12-week prospective, multicentre, randomised Phase 4 study to evaluate the effect of a wild type strain of Lacticaseibacillus in cholesterol of blood levels.

NCT ID: NCT06059911 Active, not recruiting - Sport Performance Clinical Trials

Pre-workout Supplementation and Basketball

Start date: June 15, 2022
Phase: N/A
Study type: Interventional

Pre-workout supplements (PWS) consumption in recreationally or physically trained males lead to many performance-enhancing benefits, including improvements in mean power output during single and repeated sprints, agility, reaction times, lower body muscular endurance and reduced fatigue. PWS ingestion also improves anaerobic performance and prolongs time to exhaustion during high-intensity intermittent exercise. However, PWSs' effectiveness is not constant, as they do not alter anaerobic power, jumping performance or blood lactate concentrations after a training session, at least in recreationally trained males and strength-power athletes. Moreover, the effects of long-term PWS supplementation, where some nutritional agents were combined (e.g., β-alanine, creatine, citrulline malate, etc.) to assess endurance-trained runners or elite cyclists' performance, are mixed and less clear. Even though the popularity of PWS use has increased among trained/professional athletes, most of the data in this area are derived from recreationally and not from well-trained athletes of a competitive level (especially in team sports). Therefore, the present study aimed to examine the acute and chronic effects of a PWS, containing 200 mg caffeine, 3.3 g creatine monohydrate, 3.2 g βalanine, 6 g citrulline malate and 5 g BCAA per dose, on shooting, jumping, sprinting, agility, aerobic and anaerobic performance in well-trained basketball players.

NCT ID: NCT05982990 Active, not recruiting - Bioequivalence Clinical Trials

Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers

Start date: August 1, 2023
Phase: Phase 1
Study type: Interventional

Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder

NCT ID: NCT05977543 Active, not recruiting - Healthy Clinical Trials

Acute Effect of Functional Crackers on Postprandial Metabolism

Crade23
Start date: February 15, 2023
Phase: N/A
Study type: Interventional

The aim of this interventional study was to investigate the postprandial effect of two types of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with β-glucan, in metabolic biomarkers of healthy participants.

NCT ID: NCT05915182 Active, not recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive (COPD)

Real-world, 52-week Prospective Study to Capture the Reasons for Switch to Triple Combination Therapy, Assess the Clinical and Patient Reported Outcomes in Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Trixeo Aerosphere™ in Routine Care Settings in Greece

TRIAENA
Start date: July 21, 2023
Phase:
Study type: Observational

Chronic obstructive pulmonary disease (COPD) is a debilitating and progressive respiratory condition characterized by irreversible airflow limitation. The overall 5-year survival for COPD patients is 56-92%, depending on disease severity. Considering the recent introduction of the Budesonide, Glycopyrronium bromide and Formoterol fumarate Metered-Dose Inhaler (BGF MDI) in COPD therapeutic arsenal as well as the increasingly important role of real-world (RW) data in health care decisions, as it bridges gaps not addressed by randomized clinical trials, there is a need for RW evidence studies that can serve as inputs for Health Technology Assessment (HTA) submissions. In view of this need, this study is designed to generate RW evidence on the clinical and patient-reported outcomes of treatment with BGF MDI over a 52-week treatment period in routine care settings in Greece as well as to shed light on the reasons for switching from dual to triple therapy with BGF MDI, aiming at further characterizing the multifactorial aspects of inadequate COPD management that lead physicians to step-up treatment. The study is mainly descriptive in nature and is not planned to reject or affirm any formal statistical hypothesis. This is a single-country, non-interventional, multicenter, 52-week prospective cohort study, mainly based on primary data collection, which will include adult patients with moderate to severe COPD newly prescribed maintenance treatment with BGF MDI in routine care settings of Greece. This study design has been selected on the basis that such studies essentially, through collecting data generated in the course of routine clinical care about management practices and their outcomes from both the physician and patient perspective, help to bridge the knowledge gap between clinical research in controlled randomized settings and daily clinical practice. In line with the purely observational and non-interventional nature of the study, no changes to the current standard of care will be required and all aspects of treatment and clinical management of patients will be in accordance with local clinical practice and at the discretion of the participating physicians. The conduct of this study will adhere to the applicable national regulatory requirements governing the conduct of such type of clinical research. In addition, the study has been designed and will be conducted and reported in accordance with the ethical principles laid down in the Declaration of Helsinki, the Guidelines for Good Pharmacoepidemiology Practice (GPP) of the International Society for Pharmacoepidemiology, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines where applicable, the European Union (EU) General Data Protection Regulation (GDPR), and the local rules and regulations. Patients will have been prescribed BGF MDI (Trixeo Aerosphere™) prior to informed consent (IC) obtainment and will be treated according to the local prescribing information (Summary of Product Characteristics [SmPC]) of the study medication and routine medical practice in terms of visit frequency and type of assessments performed. The assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of BGF MDI is clearly separated from the physician's decision to include the patient in the current study. In addition, every medical decision including the course of treatment will reflect exclusively the decision of the treating physician in a routine clinical situation according to the product's SmPC. Follow-up visit frequency will be determined by the treating physician, however study-related data will be collected at study enrollment and at 12, 24, 36, and 52-week data collection timepoints post-index (i.e., after BGF MDI treatment initiation) with an allowable time window of ±2 weeks for each data collection timepoint. Data collection at the aforementioned timepoints will be performed in the context of on-site routine visits at the private practices/hospital clinics. In addition, a telephone contact will take place at 4 (±1) weeks post-index for the sole purpose of administering COPD Assessment Test (CAT) by phone interview with the patient. Any visits/contacts occurring at other times not pre-planned in the context of the study will not be captured for the purposes of this study, except for safety-related information, exacerbation data, information on BGF MDI and concomitant COPD-related treatments, that will be collected on a continuous basis. Data collection at all indicated timepoints will be performed in the context of on-site routine visits at the private practices/hospital clinics. There are no dose regimens or diagnostic procedures pre-defined within this study plan. Participation in this observational, real-life study and its documentation procedure will not affect the routine treatment situation in any way.

NCT ID: NCT05909592 Active, not recruiting - Shoulder Injuries Clinical Trials

Shoulder Injury Rate and Risk Among CrossFit Participants in Greece. Εfficacy of an Innovative Prevention Program.

Start date: September 24, 2022
Phase:
Study type: Observational [Patient Registry]

CrossFit is a modern sport, introduced to the public in 2000 and popular quickly with more than 15,000 affiliates worldwide. Due to the highly demanding nature of the workouts, it is claimed to be a sport with a high prevalence of injuries. Most preliminary retrospective studies had shown that shoulder area is injured most frequently, at about a quarter of all injuries. Therefore, the initial goal of this observational (prospective cohort) study is to learn about the incidence rates of shoulder injuries and potential risk factors in a Greek population of CrossFit participants. Based on these results, this study's ultimate purpose is to create a short warm-up program capable of reducing shoulder injuries and evaluate its effectiveness. The main questions it aims to answer are: - Are shoulder injuries as frequent as previous studies have shown to be? - Can we blame for these injuries a previous history of musculoskeletal injury or deficits of range of motion, strength, and muscular endurance? - Can a short warm up which targets revealed deficiencies be effective in reducing shoulder injuries incidence rates? Participants will be asked to: - take part in baseline measurements (personal data, previous musculoskeletal history, shoulder and core range of motion, shoulder and hip muscle strength, shoulder stabilizers endurance, functional assessment sport-specific tests) - be monitored for new shoulder injuries or aggravation of old shoulder injuries that will occur during 9 months following baseline measurements. In this case, they must refer it to their coaches to be contacted and assessed by the researcher. - follow the warm up which will be created by the researcher 3 times per week for 8 to 10 weeks.

NCT ID: NCT05906420 Active, not recruiting - Stroke Ischemic Clinical Trials

Posterior Circulation ASTRAL Prognostic Score

Start date: January 1, 2003
Phase:
Study type: Observational

The goal of this study is to develop a prognostic score for ischemic posterior circulation strokes, based on our previous work on with the ASTRAL scores (Acute STroke Registry and Analysis of Lausanne) on overall stroke prognosis, intracranial occlusion, recanalization and stroke recurrences. The main question it aims to answer is the modified Rankin score in 3 months after the event. Participants will be patients with acute ischemic stroke of the posterior circulation with mRS priot to event <3. All the data will be collected retrospectively from patients included in the ASTRAL registry between January 2003 and December 2021. The ASTRAL registry will be used as the derivation cohort of the score. Demographics, acute glucose, NIHSS score and acute imaging of each participant will be used from the derivation cohort in order to create an integer-based prognostic score. After internal validation, we plan to validate the score in external stroke registries to show its validity.

NCT ID: NCT05896943 Active, not recruiting - Ulcerative Colitis Clinical Trials

The Application of Transcriptomics in the Treatment of Ulcerative Colitis With Ustekinumab

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

The investigators hope that the present study will highlight new transcriptomic prognostic markers of response to Ustekinumab with the ultimate goal of individualizing treatment and making a more targeted selection of UC patients who will benefit from this biological agent.

NCT ID: NCT05872620 Active, not recruiting - Obesity Clinical Trials

A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

ATTAIN-2
Start date: June 5, 2023
Phase: Phase 3
Study type: Interventional

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

NCT ID: NCT05870371 Active, not recruiting - Neck Pain Clinical Trials

The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain

FMvsCNP
Start date: September 26, 2022
Phase: N/A
Study type: Interventional

This doctoral thesis is a single blind randomized controlled clinical trial with an active control element. The intervention examined in this trial is the Awareness Through Movement (ATM) technique of the Feldenkrais Method (FM), while the standard treatment given to the control group is the combination of acupuncture and stretching. The study was designed to examine the extend of the effect of ATM, as a means of reduction of pain, improvement of functionality and psychosomatic parameters of patients with chronic neck pain, in comparison to biomedical acupuncture protocol in combination with stretching. The effectiveness of the intervention will be compared to the effect of the standard treatment, a combination of acupuncture and stretching, in relation to parameters of pain, range of motion of rotation, flexion-extension and lateral flexion of the cervical spine and the sense of position (kinesthesia), the endurance of the cervical deep flexor muscles, respiratory function and psychometric characteristics, which are evaluated at specific times (before and after the intervention-five weeks). During the discussion, the results of this study, in combination with the degree of validity of the observation, will be compared to those of the literature review. This comparison could contribute to the more effective clinical application of ATM in the treatment of chronic neck pain, either as part of physiotherapeutic rehabilitation, or as a unique approach.