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NCT ID: NCT06176963 Completed - Macular Edema Clinical Trials

A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO

Start date: November 21, 2023
Phase: Phase 2
Study type: Interventional

This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.

NCT ID: NCT06150105 Completed - Clinical trials for Overtraining Syndrome

Changes in the Hormonal and Inflammatory Profile of Young Sprint- and Endurance-trained Athletes.

CHIPYA
Start date: February 16, 2018
Phase:
Study type: Observational

One essential element of athlete training is conditioning camps, where athletes undergo a rigorous and targeted training schedule to prepare for upcoming sporting events. During sports camps, due to the accumulation of a large number of training units, including high-intensity exercises, athletes react with post-exercise overload, acute fatigue, and overreaching which can become a chronic overtraining syndrome. Overtraining syndrome is a very specific and severe condition where overtraining without adequate rest and recovery leads to performance decrements lasting more than 2-3 months, coupled with a mood disturbance. The exact etiology and pathogenesis are unknown and actively being investigated. During training camps the balance between training volumes and recovery is often a delicate one and, the accumulation of exercise-induced stress may exceed the capacity of both neuroendocrine and immune adaptation leading to an alteration of physiological functions, decreasing adaptation to performance, impairment of psychological processing, immunological dysfunction, and biochemical abnormalities. Moreover, there is currently a lack of biomarkers accessible to assist in diagnosing and, what's even more important - help to prevent the overtraining syndrome, except for the continued presence of unexplained underperformance despite athletes' adequate rest and recovery. Thus, this study aims to explain how long and intensive training for endurance affects the hormonal and immune systems of young athletes. The main questions it aims to answer are: 1. How does intense training influence hormonal and immune responses in young, trained athletes? 2. Does training specialization affect the hormonal and immune response to intense training?

NCT ID: NCT06138015 Completed - Menopause Clinical Trials

Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

The goal of this quasi-experimental study is to test effect of time-restricted eating on cognitive function and other biopsychosocial factors in menopausal women undertaking a 12-week exercise programme. The main questions to answer are: 1. What is effect of time-restricted eating on cognitive function in menopausal women undertaking a 12-week exercise programme? 2. What is effect of time-restricted eating on menopausal symptoms in menopausal women undertaking a 12-weeks exercise programme? 3. What is effect of time-restricted eating on metabolic health parameters in menopausal women undertaking a 12-weeks exercise programme? Participants of both groups will have moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks. Participants of one of two groups will not only exercise but also have a time-restricted eating following 16:8 protocol for 12 weeks. Participants will have pre-tests and post-tests: - blood samples collection (to measure level of brain-derived neurotrophic factor, glial cell derived neurotrophic factor, insulin, glucose, lipid profile), - body composition analysis, - Stroop test and N-back test, - electroencephalography using Emotiv Epic X devices, - One-repetition maximum test, Ruffier test, - Questionnaire assessment (using Menopause Rating Scale and The Menopause-Specific Quality of Life Questionnaire). Researchers will compare two groups - exercise group and combination group which will do both time-restricted eating and exercise to see if there is a modulating effect of time-restricted eating in participants undertaking exercise.

NCT ID: NCT06133751 Completed - Clinical trials for Permeability; Increased

Effect of 8-week Supplementation With Black Chokeberry on Recovery in Highly Trained Rowers

Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

Purpose: To analyze the effects of 8-week supplementation with anthocyanin compounds contained in black chokeberry (Aronia melanocarpa) on indicators of inflammation and oxidative stress. Hypothesis: Supplementation with anti-inflammatory and antioxidant anthocyanin compounds improves recovery from intense exercise by reducing inflammation and oxidative stress in highly trained rowers The study consisted of a nutritional intervention (supplementation) - with compounds of natural origin - chokeberry extract (capsules) - 18% standardized for anthocyanin content (dose 3 x 200 mg per day) - that is, 107 mg of pure anthocyanins per day, or a placebo product that was made from chokeberry fiber Study plan I term of the study 1. Conduct a body composition analysis, body height, food diary, self reported gastrointestinal scale 2. Collection of blood samples before the exercise test for biochemical determinations. 3. Exercise test of 2000m on a rowing ergometer. 4. Collection of blood immediately after exercise and 1 hours after 5. Collection of blood for biochemical determinations 24 hours after the end of the exercise test 6. Supplementation for 8 weeks 2nd test date Repeat the measurements from the 1st test date. Participants: Youth National Rowing Team of Poland Experimental procedure: Observation of the effect of black chokeberry consumption on parameters of inflammation, oxidative stress and intestinal parameters during the immediate start preparation period in highly skilled rowers.

NCT ID: NCT06131333 Completed - Clinical trials for Complex Coronary Artery Disease

Complex CAD Treated With PCI With DES Implantation.

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

COMPLEX Registry is an investigator-initiated, retrospective, high-volume Polish single-center clinical registry enrolling 980 consecutive patients with complex coronary artery lesions treated percutaneously between September 2015 and December 2021. All data were collected prospectively as regards the clinical and technical endpoints. The study aimed to assess the safety and efficacy of new-generation, thin-struts DES in patients with complex CAD at long-term clinical follow-up. The primary endpoint of the study was the occurrence of TLR during follow-up. Secondary endpoints were a procedural success and the occurrence of MACE, including all-cause death, MI, or TLR.

NCT ID: NCT06127186 Completed - Clinical trials for Upper Respiratory Tract Infections

Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections

Start date: November 1, 2023
Phase:
Study type: Observational

The goal of this longitudinal study is to assess headache and facial pain features in patients with upper respiratory tract infections (URTI). The main question it aims to answer are: 1. What is the phenotype of headache / facial pain in URTIs 2. Does the above mentioned phenotype is associated with: 1. aetiologic factor (virus), 2. type of URTI 3. headache/facial pain experienced by patients in the past. Participants will: - answer standardized questions, - undergo physical examination, - have a swab test performend for antigens of common viruses causing URTI.

NCT ID: NCT06116591 Completed - Clinical trials for Healthy Participants

A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers

Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to learn about the effects of a monovalent (single component) pneumococcal conjugate candidate (mPnC candidate) when given to toddlers between 11 and 15 months of age. All participants in this study will receive 2 doses of either mPnC candidate or mPnC control at the clinic approximately 8 weeks apart. All participants will also receive their third (toddler) dose of PCV10 at Visit 1.

NCT ID: NCT06108713 Completed - Aging Clinical Trials

The Influence of Juggling on Selected Cognitive Functions and Postural Stability Variables.

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to verify the effect of juggling exercises on selected cognitive functions (reaction time, attention) and postural stability variabilities (based on center of pressure signal) in two different protocols: [1] a randomised crossover study design, [2] a randomised repeated measurement design.

NCT ID: NCT06103435 Completed - Gastric Cancer Clinical Trials

Multivisceral Resections for Locally Advanced Gastric Cancer

TOCCATA
Start date: January 1996
Phase:
Study type: Observational

The goal of this observational study is to assess whether the postoperative course and survival of patients subject to multivisceral resections for locally advanced gastric cancer (cT4b) were affected by the extent of surgery. An electronic database of 1476 patients with non-metastatic gastric cancer treated between January 1996 and December 2020 will be reviewed. The main questions it aims to answer are: - Does splenectomy, distal pancreatectomy or partial colectomy affect postoperative complications - What factors affect prognosis of patients with locally advanced gastric cancer

NCT ID: NCT06100848 Completed - Dental Caries Clinical Trials

Hydrogen Peroxide Fumigation in Dental Office Environment

Start date: January 3, 2023
Phase: N/A
Study type: Interventional

The study's null hypothesis posits no significant difference in bacterial levels in the dental office environment before and after implementing hydrogen peroxide (H₂O₂) fumigation. The study comprised 30 participants, 18 females and 12 males, all diagnosed with moderate caries decay (ICDAS 3 and 4) in their mandibular molars, averaging 42.2 ± 8.3 years in age. Sample size calculations for 30 microbiological plates in each group utilized G*Power software (Kiel University, Germany), factoring in prior research, with a significance level of 0.05, effect size (d) of 0.72, 95% confidence interval, and 85% power. Aerobic bacterial content in the dental office air was assessed using the Koch sedimentation method. The study employed 60 Petri dishes with Columbia Agar and 5% Sheep Blood. During caries treatment, thirty plates were opened and sealed 40 minutes later, while another set of thirty plates was opened and closed 60 minutes post-fumigation. Measurements were taken 1 meter above the ground and 2 meters from the patient's mouth. After 48 hours of incubation at 37°C, microbiological contamination was calculated as CFUs (colony-forming units) in one cubic meter using the formula: L = a × 1000 / (πr² × k). Fumigation involved a 20-minute treatment with 6% hydrogen peroxide biosanitizer (Saniswiss, Switzerland) via a compressed air device (Fumi-Jet, Kormed, Poland). The process included 3 minutes of fumigation and a 17-minute waiting period for the chemotoxic effect, with 45 ml of 6% hydrogen peroxide sprayed in a 20 m² room.