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NCT ID: NCT05439720 Active, not recruiting - Sleep Clinical Trials

Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise

Start date: May 15, 2022
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the effect of oral ketone ester administration on sleep architecture. To investigate this, the investigators use a randomised, placebo-controlled, cross-over research design. The study comprises three experimental sessions, each separated by a one-week washout period. Two of the three experimental sessions consist of a 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime. After each training session, and 30 minutes before sleeptime, subjects receive a ketone ester or a control drink . To investigate the effects of strenuous exercise on sleep alone, an additional experimental session without exercise is added. Before bedtime, a venous blood sample is taken to evaluate hormones playing an important role in sleep regulation. During the experimental sessions, the subjects sleep in a sleep facility to evaluate quality of sleep. Time spent in different sleep phases is measured via polysomnography (PSG). Urine output throughout the day and night will be collected for measurement of urinary excretion of adrenaline and noradrenaline as an index of intrinsic sympathetic activity.

NCT ID: NCT05439239 Recruiting - Hypoxia Clinical Trials

Effects of Hypoxic Repeated Sprint Training on Performance in Normoxia in Male and Female Athletes

RSHwomen
Start date: April 21, 2022
Phase: N/A
Study type: Interventional

With the increased participation of women in sports, it is essential to develop gender-tailored training strategies for improving exercise performance. Males and females exhibit gender-specific characteristics and they therefore respond differently to physical exercise. Improving repeated sprint ability (RSA, i.e., ability to perform repeated short duration sprints separated by brief recovery intervals) in women is important for sports performance, as it is a key factor in most team and racket sports. Repeated sprint training in hypoxia is increasingly popular in this field, as it has demonstrated further improvements in sea-level repeated sprint performance than similar training in normoxia. However, these observations are based mainly on male athletes. Whether the effects of hypoxic repeated sprint training on repeated sprint performance in normoxia differ between genders is not yet known, therefore the investigators propose to examine those possible differences in this study. The aim of this study is to investigate whether the effects of hypoxic repeated sprint training on repeated sprint performance in normoxia differ between males and females who participate in team/racket sports. Considering the sex-specific characteristics that males and females exhibit, the investigators hypothesize that after 7 weeks of hypoxic repeated sprint training the improvements in repeated sprint ability at sea level will be greater in males than in females. To answer this question, the investigators will measure the following: body composition (lean body mass); body weight and height; VO2max; blood (estrogen, lactate, hemoglobin, hematocrit); repeated sprint ability (RSA) test; muscle oxygenation (concentrations for oxyhemoglobin, deoxyhemoglobin, and total hemoglobin/myoglobin); 30-s Wingate test; heart rate (HR); power output; rate of perceived exertion (RPE); visual analogue scale (VAS; pain level in legs). The investigators will recruit 48 volunteers and they will randomly assign them into the normoxic or hypoxic training group, without giving any information about their group. The volunteers should meet the following inclusion criteria: females (on monophasic oral contraceptive pill) and males, age between 18-40 years, recreationally participating in team/racket sports min 3h/week with at least 2 years of experience prior to the study. Exclusion criteria will be: smoking, exposure to altitude >1500 m one month before the study, any health conditions or injuries that could compromise the participant's safety during training/testing, prescribed medication, performing repeated sprint training more than once per week. Males and females, matched for VO2max and sprint performance, will perform repeated sprint training (3 sets during week 1-6, 2 sets during week 7 with 5min active recovery in between, 5 x 10s maximal sprints with 20s active recovery in between) in hypoxia or normoxia 2x/week for 7 weeks. Before and after the training period, the following tests and measurements will be performed: body composition analysis, VO2max test, blood sampling for measuring hemoglobin and estrogen concentrations and hematocrit, determination of hemoglobin mass, RSA test, muscle oxygenation assessment during RSA test, 30-s Wingate test and blood lactate measurements.

NCT ID: NCT05438862 Not yet recruiting - Clinical trials for Aortic Valve Regurgitation

Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation

ELEANOR
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with conventional guideline-based strategy in asymptomatic patients with severe aortic regurgitation.

NCT ID: NCT05438238 Not yet recruiting - Infertility Clinical Trials

Virtual Reality for Acute Pain and Anxiety During Egg Retrieval for in Vitro Fertility Treatment.

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

This study is a comparison between the current standard practice of performing a transvaginal oocyte retrieval (TVOR) with paracervical block (PCB) and a relatively recently developed technology of virtual reality that is added to the above mentioned standard practice of TVOR + PCB. The aim of the study is to find out whether this newer technology has an advantage for the patient, in terms of anxiety and pain reduction or satisfaction.

NCT ID: NCT05437900 Not yet recruiting - Clinical trials for Coronary Artery Disease

INSIGHTFUL-FFR Clinical Trial

Start date: June 30, 2022
Phase: Phase 4
Study type: Interventional

Recently, a new device for measuring physiological lesion severity, the pressure microcatheter, was introduced. The pressure microcatheter provides similar information to the conventional measurement technique but differs as it is easily advanced on a customary coronary wire and simplifies pullback maneuvers. The pressure microcatheter has been shown to provide comparable FFR results to pressure wires. Insightful-FFR is an investigator-driven, multicenter, randomized, open-label and prospective trial of patients with stable coronary artery disease or stabilised non-ST elevation acute coronary syndrome (ACS) with epicardial stenosis considered for PCI aiming at comparing clinical outcomes between pressure microcatheter and pressure wire-guided strategies. The study hypothesis states that the use of a Pressure Microcatheter for clinical decision making would be non-inferior to pressure wire-based strategy After determining the presence of a coronary artery disease/ stabilized acute coronary syndrome, patients will be randomized to use a pressure microcatheter (investigational device) or a pressure wire (comparator) to guide and optimize percutaneous coronary intervention (PCI). Patients will be followed up in hospital at 12 months and yearly until five years.

NCT ID: NCT05435950 Not yet recruiting - Clinical trials for Carpal Tunnel Syndrome

Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments

SONO-01
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Carpal Tunnel (CT) syndrome is a collection of characteristic symptoms and signs that occurs following compression of the median nerve within the CT. In Trigger Finger / trigger thumb (TF), one of the most common causes of hand pain and disability, the flexor tendon causes painful popping or snapping as the patient flexes and extends the digit. In case of failure of non-operative treatments, patients with CT syndrome or TF are operated. Clearly any improvement in surgical device design would be of great advantage to the patient and the surgeon. Spirecut's single use, pre-CE Sono-Instruments (SI) allow the percutaneous treatment of Carpal Tunnel (CT)syndrome and Trigger Finger/thumb (TF) under sonography (instead of open or endoscopic approach). Two models will be assessed in this clinical investigation: 1. The Carpal Tunnel Sono-Instrument® (CT-SI), for CT syndrome release, by progressively cutting the transverse carpal ligament. 2. The Trigger Finger Sono-Instrument® (TF-SI), for TF release by progressively cutting the A1 annual pulley. Using those SI, surgical procedures can be performed without endangering adjacent structures (e.g. median nerve and branches, ulnar pedicle, superficial carpal arch, digital pedicles, flexor tendons).

NCT ID: NCT05434559 Active, not recruiting - Type 1 Diabetes Clinical Trials

Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec

GLADE
Start date: February 20, 2022
Phase:
Study type: Observational

Retrospective multicenter study analyzing data gathered from medical records and diabetes management platforms to assess the effect of using Insulin Degludec (Tresiba®) on measures of diabetes control. People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 will be included. Glycemic control from 12 months before the switch to Insulin Degludec will be compared to glycemic control of the 12 months after the switch.

NCT ID: NCT05433675 Not yet recruiting - Healthy Clinical Trials

A Study of Two Macitentan Formulations in Healthy Adult Participants

Start date: June 23, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the bioequivalence of macitentan on the primary pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan tablet and the opsumit tablet in healthy adult participants in fasted conditions.

NCT ID: NCT05432843 Recruiting - Globus Sensation Clinical Trials

A Randomized Controlled Trial Comparing Pregabalin and Placebo in Patients With Persistent Globus Sensation

Lyrica
Start date: March 12, 2010
Phase: Phase 4
Study type: Interventional

To evaluate the relative merits, safety and effectiveness of pregabalin in globus patients compared with placebo.

NCT ID: NCT05430620 Recruiting - Clinical trials for Kidney Transplant; Complications

Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys

HMPO2
Start date: March 20, 2022
Phase: Phase 3
Study type: Interventional

The aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from DCD donors, during HMP on early graft function in clinical practice.