cyrilzakka/clinical-trials huggingface dataset:
Genetic Determinants of Exercise-Induced Muscle Damage (POLYGENDOMUS)

The objective of this study is to evaluate the association between the evolution of plasma CPK levels and genetic polymorphisms, both before the muscle-damaging exercise and at three post-exercise time points. The investigators aim to include 300 participants in this research.

Elite-level sports expose athletes to training loads designed to induce muscle damage, aiming to achieve optimal physiological adaptations. However, the repetitive nature of such damage increases the risk of injury. The ability to assess an athlete's susceptibility to fragility is therefore crucial for optimizing their training and performance. Genetic factors appear to play a significant role in the occurrence of these injuries, particularly through subtle variations in DNA sequences. Depending on the location of these variations within a gene, they may or may not alter the expression or function of the associated protein. The investigators aimed to investigate the relationship between genetic polymorphisms and biological parameters in the context of exercise-induced muscle damage.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged between 18 and 35
* Weighing more than 50 kg
* Member of a sports club affiliated to an Olympic federation
* Socially insured
* Willing to comply with all study procedures and duration of the study

Exclusion Criteria:

* Medical history contraindicating sporting activities
* Current medical treatment
* Not a member of a sports club affiliated to an Olympic federation
* Administrative reasons: impossibility of receiving informed information, impossibility of participating in the entire study, absence of social security coverage, refusal to sign consent form.
Effect of Passive Heat Therapy on Metabolism

The goal of this prospective interventional study is to examine if repeated brief hot stimuli affects glucose metabolism and substrate oxidation in young non-obese adults. Young adult participants were asked to participate in fourteen 5-min procedures involving whole body passive heating at 45°C water.

The main question it aims to answer is: "Does repeated brief noxious heat stimuli is sufficient to improve glucose tolerance, insulin sensitivity, and fat oxidation in young non-obese adults?"

No studies yet addressed whether brief heat stimuli could be viable time-efficient alternative approach in order to improve glucose metabolism and fat oxidation. Consequently, we aimed to examine the ability of brief noxious heat stimuli to improve glucose tolerance, insulin sensitivity, and fat oxidation in young adults. Non-obese males and females completed fourteen 5-min sessions involving whole body passive heating at 45°C water. Changes in catecholamines, cytokines, substrate oxidation, resting energy expenditure, glucose tolerance and insulin response were assessed.

Eligibility Criteria:
Inclusion Criteria:

* healthy non-obese (BMI between 18.5 and 29.9 kg/m2) males and females;
* no diseases, or conditions that could be worsened by exposure to acute hot water and affect experimental variables;
* no participation in any excessive formal physical exercise or sports program, temperature manipulation program or exposure to extreme temperatures.

Exclusion Criteria:

* smokers;
* obesity (BMI greater than 30 kg/m2);
* needle phobia;
* taking medication and/or dietary supplements that may affect experimental variables.
Be SMART NIS, Moderate to Servere Asthma Patient Observation

Screen for moderate to severe asthma patients with suboptimal asthma control (as defined by GINA-Guidelines). Document current asthma control status. Re-evaluate asthma therapy and document new therapy if applicable.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe asthma with suboptimal control

Exclusion Criteria:

* Intermittent or mild asthma, patient with good asthma control
An Evaluation of the FreeStyle Flash Glucose Monitoring System

The usability, skin reactions and accuracy of the FreeStyle Libre glucose monitoring system in children will be evaluated by questionnaires, pictures of the insertion site and comparison of the glucose results with capillary blood glucose determinations.


Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes mellitus
* being followed in the Pediatric Diabetes Unit of the Jessa Ziekenhuis

Exclusion Criteria:

-
Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease

Background: About 5% of patients with acute coronary syndrome (ACS) have had previously ischemic stroke (IS) or transitory ischemic attack (TIA). This is a high-risk population, with a high incidence of ischemic events, and also of bleeding events. While the high ischemic risk in this population is attributed to a higher prevalence of cardiovascular risk factors, their predisposition to bleeding events is not well understood. Hypothesis: The increased bleeding risk in ACS patients with history of cerebrovascular event may be justified by a low platelet activity. Methods: Unicentric, prospective, case-control study, which included approximately 100 post-ACS patients with history of IS/TIA previously to the acute coronary event (Case Group) and 100 patients without IS/TIA (Control group). The groups were matched for gender, age, and ACS type and year of occurrence. All patients were taking aspirin, and the main exclusion criteria were use of dual antiplatelet therapy, previous hemorrhagic stroke, severe renal dysfunction, thrombocytopenia or coagulopathy. Main analysis: Platelet aggregation was evaluated by 6 methods: VerifyNow Aspirin®, VerifyNow P2Y12®, PFA 100®, thrombelastography (ReoRox®), light transmission aggregometry with ADP (LTA ADP) and epinephrine (LTA EPI) as agonists. Additional analysis: genetic, HDL transport and inflammatory evaliation


Eligibility Criteria:
Inclusion Criteria:

* Post-ACS patients with history of IS/TIA previously to the acute coronary event and taking aspirin
* Sign the consent form

Exclusion Criteria:

* Hemorrhagic stroke
* Another antiplatelet drug than aspirin
* Use of Anti inflammatory drug
* Severe chronic kidney dysfunction
* Liver disease
* Coagulopathy
* Platelet disfunction
* Thrombocytopenia or thrombocytosis
* Refuse to sign the consent form
Strength-Endurance Circuit Training in Parkinson's Disease

The goal of this clinical trial is to determine whether adding strength training to aerobic training has a comparable or greater effect on the clinical status of Parkinson's disease patients than a standalone aerobic training.

- Does combined strength-endurance circuit training provide added benefits to physical performance, disease severity, blood biomarkers, and quality of life in PD patients compared to standalone aerobic training?

Participants will:

* undergo outcome measurements before and after the 12-week intervention and a 3-month follow-up measurement,
* visit the clinic twice a week for 1-hour training sessions.
* selected patients will be given a smartwatch with a pedometer that will count their average number of steps before, during and after the training period


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* diagnosis of idiopathic Parkinson´s disease
* Hoehn-Yahr Scale ≤ 2,5
* stable dopaminergic medication

Exclusion Criteria:

* age ≥75 years
* Hoehn-Yahr Scale ≥ 2,5
* deep brain stimulation
* presence of freezing
* Camptocormia
* inability to walk without support
* inability to perform study procedures
* limiting co-morbidities
* attendance at training sessions below 70%
Assessment of Physical Performance After Oral Supplementation of Magnesium in a Sample of Old Women in Good Health

Magnesium deficiency is associated also in the elderly with low physical performance; nevertheless trials about the effect of supplementation of magnesium on physical performance are not available in old people. The aim of our study is to investigate whether 12-weeks of oral magnesium supplementation improves physical performance in healthy elderly women


Eligibility Criteria:
Inclusion Criteria:

* People over 65 years, not residents in nursing home, in good health

Exclusion Criteria:

* previous supplementation of calcium, potassium or magnesium
* use of pump proton inhibitors or digitalis
* important co-mordidities such renal failure
ENVELOP: Wound Care Following Pilonidal Sinus Surgery

This is a single-blinded, multicentre, prospective randomised controlled trial (RCT) comparing post-operative and patient-reported outcomes for patients undergoing application of negative-pressure wound therapy (NPWT) after sinus tract excision as compared to excision and standard open wound care in chronic pilonidal sinus disease (PSD).

Pilonidal sinus disease (PSD) is a chronic inflammatory condition of the skin and subcutaneous tissues arising from hair follicles in the natal cleft. The definitive aetiology of the condition is unknown, however, it is theorised that it is the result of either the obstruction and subsequent inflammation of hair follicles or secondary to hair penetrating through the skin into the subcutaneous tissue. This results in infection, abscess formation, chronic discharge and pain. PSD is a common condition affecting 26 per 10,000 population, with the prevalence reaching 1.1% in young adult males.

PSD causes a significant burden on healthcare services due to high rates of recurrence and readmission following surgery, together with negative impacts on patients' quality of life and self-image. An effective management strategy for the disease is necessary to ensure that post-operative outcomes are optimised and patient-reported outcomes are satisfactory in those whose PSD requires surgery.

The objective of this multicentre, national RCT is to prospectively investigate the effect of negative pressure wound therapy compared to leaving open with standard wound care on time to wound healing following surgical excision of chronic PSD.

Eligibility Criteria:
Inclusion Criteria:

i) They are aged 18 years or older

ii) They are undergoing elective pilonidal sinus excision without primary closure

Exclusion Criteria:

i) They are unable to adhere to protocol requirements e.g. questionnaire completion

ii) They are undergoing emergency drainage for a pilonidal abscess

iii) They are undergoing surgery for a pilonidal sinus disease in locations other than the natal cleft

iv) They have underlying osteomyelitis

v) They have underlying fistulating disease e.g. Crohn's
CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.

The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study. Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Mean 24 hour ambulatory systolic blood pressure ≥145 mmHg and ≤200 mmHg and stable for at least 8 weeks on a maximally tolerated guideline directed, (JNC8) or their equivalent when those listed are not available dosing regimen consisting of up to 5 antihypertensive medications, with a minimum required dosing regimen of an "A+C+D" antihypertensive medication regimen, where "A" is an angiotensin-converting enzyme Inhibitor or an angiotensin receptor blocker, "C" is a calcium channel blocker, and "D" is a diuretic.

Exclusion Criteria:

* Inadequacy of the carotid anatomy for treatment with the MobiusHD based on carotid angiography.
Comparison of the Effects of Aerobic Exercise Training and Mat Pilates Exercise on Blood Pressure, Functional Capacity and Quality of Life in Hypertensive Individuals

The research aims to compare two different exercise approaches applied to hypertensive individuals. After completion of the research, it will be revealed which exercise approach is more effective on the parameters evaluated in hypertensive individuals. In this context, it is aimed to increase the use of the exercise approach, which is found to be more effective in hypertensive individuals, in the treatment program.

Exercise is an important lifestyle change in treating and controlling hypertension. The International Society of Hypertension recommends increasing physical activity in the long term as a lifestyle intervention to improve blood pressure control and reduce the risk of cardiovascular disease in hypertensive individuals. Regular exercise appears to reduce drug use as part of lifestyle change in the treatment of hypertension. The risk of developing hypertension in individuals with a sedentary lifestyle is higher than in individuals who engage in regular physical activity.

In addition, new exercise programs such as mat pilates exercises are also applied to hypertensive individuals. Mat pilates exercises are a resistance exercise method used worldwide, especially for middle-aged individuals who do not engage in regular physical activity. In addition, Mat pilates exercises have promising effects, reducing short-term systolic blood pressure by 7.4 mmHg and long-term resting systolic blood pressure by 5.8-7.6 mmHg and diastolic blood pressure by 3.3-3.6 mmHg. These data require further research on the use of mat pilates exercises in hypertensive individuals.

The research aims to compare two different exercise approaches applied to hypertensive individuals. After completion of the research, it will be revealed which exercise approach is more effective on the parameters evaluated in hypertensive individuals. In this context, it is aimed to increase the use of the exercise approach, which is found to be more effective in hypertensive individuals, in the treatment program.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension (blood pressure ≥ Individuals diagnosed with 85/135 mmHg) and under medical follow-up,
* Volunteering to participate in the study,
* Not having been included in any exercise program in the last 4 weeks.

Exclusion Criteria:

* Blood pressure Individuals with ≥ 110/180 mmHg,
* Having had a cerebrovascular accident or cardiovascular disease in the last 6 months,
* Having an orthopedic or neurological disorder that prevents walking.
* Having serious cardiovascular/pulmonary disease.
ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19

This study is open to adults with COVID-19 infection who are in hospital and receive oxygen. Participants need to be 50 years of age or older and need to be at risk of further worsening of their condition.

The purpose of the study is to find out whether a medicine called BI 764198 helps people with COVID-19 infection and breathing problems. BI 764198 may prevent cell death and swelling of the lung tissue and therefore help patients with COVID-19 infection.

Participants are put into 2 groups by chance. One group of participants gets BI 764198 capsules and the other group gets placebo capsules. The placebo capsules look exactly like the BI 764198 capsules but do not contain any medicine. Participants take 1 capsule per day.

Participants are in the study for about a month. At study end, doctors compare the 2 groups for the number of patients that are alive and do not need mechanical breathing support. During the study, the doctors collect information on any health problems of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* SARS-CoV-2 infection positive confirmed by PCR or approved point-of-care test
* A score of 5 (hospitalised; oxygen by mask or nasal prongs) or 6 (hospitalised; oxygen by non-invasive ventilation or high flow), but not previously ≥7, on the WHO Clinical Progression Scale.
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
* Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must abstain from male female sex or must use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly during hospitalisation for at least 7 days after last trial drug intake

Exclusion Criteria:

* Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \>5 × the upper limit of normal (ULN).
* Known active infection with HIV or hepatitis B or C.
* Pulmonary oedema/respiratory failure due to cardiogenic insult.
* Previous to hospitalisation, on long-term oxygen therapy.
* A confirmed baseline prolongation of QTc interval to greater than 450 ms in males or 470 ms in females according to the Bazett formula, or any other relevant ECG finding at screening, or concomitant use of medication prolonging QT interval.
* Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR \<30 mL/min/1.73 m2).

History of the following cardiac conditions:

* Myocardial infarction within 3 months prior to the first dose
* Unstable angina
* History of clinically significant long QT features on electrocardiogram (ECG) or history of familial long QT

  * Anticipated transfer/discharge to another hospital or care facility other than their place of residence
  * Further exclusion criteria apply
Does the Optic Disc Grading Done Visually by Your Doctor Agree With Optic Nerve Testing Which is Done by Machines?

The purpose of this study is to determine how well the DDLS (Disc Damage Likelihood Scale) (which is a method used by the eye doctor to evaluate how healthy the optic nerve is) measures up to the standard glaucoma tests: OCT (Optical Coherence Tomography), the HRT (Heidelberg Retinal Tomography) and the HVF (Humphrey Visual Field).

The Disc Damage Likelihood Scale (DDLS) has been shown to be a reproducible method for clinicians to evaluate the optic nerve for glaucomatous damage and is highly correlated to diagnosis of glaucoma, severity of glaucoma as evidenced by visual field loss and Heidelberg Retina Tomography (HRT) evaluation. In comparison with the commonly used cup-disc ratio, the DDLS has less inter-observer variation and captures glaucomatous aspects of the optic nerve not assessed by the cup-disc ratio. The optic nerve imagers do not have the potential to completely replace the clinical examination of the optic nerve since they do not assess many critical features such as optic nerve pallor, hemorrhages, asymmetry of disc size, edema, etc. The DDLS presents the opportunity to provide a system to clinicians to increase the quality and objectivity of clinical optic nerve evaluation. The purpose of this study is to investigate the correlation of the DDLS grading to OCT, HRT and HVF testing of glaucomatous and normal optic nerves.

Eligibility Criteria:
Inclusion Criteria:

* Vision 20/50 or better
* Less than 3 diopters of astigmatism
* 3 diopters or less of myopia or hyperopia
* Pattern Standard Deviation on HVF less than 2.5dB in normals
* Pattern Standard Deviation on HVF greater than 2.5 db in glaucoma patients

Exclusion Criteria:

* Abnormalities of cornea or ocular media
* Significant ocular pathologies affecting visual field
* History of hypotony
* Ocular surgery within 6 months
* Nystagmus
* Unreliable visual fields
* OCT signal strength scan less than 6
Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs

The purpose of this study is to determine the effectiveness of a brief cognitive behavioral therapy (bCBT) intervention for Veterans with depression delivered by mental health providers located at VA Community Based Outpatient Clinics (CBOC's) associated with the Houston and Oklahoma City VAMCs.

Depression is a serious health condition that places tremendous burden on patients and healthcare systems and is especially prevalent in Veterans. In 2008, the VHA released the Uniform Mental Health Services Handbook (Handbook 1160.01) in an effort to expand services for Veterans with depression, including those in primary care and CBOC settings.

The VA remains a national leader in mental health services, but the provision of psychotherapy within VA is limited, especially for rural Veterans and those cared for in CBOCs. The VA has invested significant resources to improve access to high-quality mental health care, including a rapid expansion into CBOCs. Currently, there is a need to work with clinicians and stakeholders to address practice barriers related to mental health practices in CBOCs. A recent survey of 4,200 mental health providers in VA found that, although robust expansion and improved quality of mental health care services has occurred, access to proven effective psychotherapies in CBOCs remains a focused area for improvement. The study will examine whether existing VA CBOC mental health clinicians, with training and support, can effectively administer a structured brief cognitive behavioral therapy (bCBT) intervention for Veterans with clinically elevated symptoms of depression.

Eligibility Criteria:
Inclusion Criteria:

* must have clinically significant symptoms of depression;
* must be current recipients of services at CBOCs associated with the Houston and Oklahoma City VAMCs.

Exclusion Criteria:

* cognitive impairment;
* presence of bipolar, psychotic or substance-abuse disorders.
* Veterans currently receiving psychotherapy WILL be excluded.
Intradialytic Exercise on the Fatigue, Sleep Disorder, Arterial Stiffness and Endothelial Function in Uremic Patients

To determine the effect of intradialytic cycling exercise on fatigability, sleep disorders, arterial stiffness and endothelial function in dialysis patients

The endothelium is a key regulator of vascular homeostasis and chronic exposure to vascular risk factors alters the regulatory properties of the endothelium, which progresses toward a pro-inflammatory pattern, senescence, and apoptosis. Endothelial cell integrity and function are critical to the prevention of atherosclerosis, and therefore endothelial cell injury and dysfunction are major steps in the development and progression of cardiovascular disease. Endothelial dysfunction may be the landmark of active disease process through the course of atherosclerotic cardiovascular disease, and a significant risk factor for future cardiovascular events.

Several studies had reported that not only medical treatment but also exercise could improve physical and vascular functions, dialytic efficiency, quality of sleep, fatigue and depression et al. Exercise could be classified to aerobic, Anaerobic exercise and resistance et. Several studies have shown that regular cycling exercise in hemodialysis patients could improve physical activity, sleep quality, and reduce fatigability. Therefore, exercise plays an important role in hemodialysis patients. According to these benefits, the investigator's study was designed to explore the effects of intradialytic cycling exercise on sleep quality and fatigability, adipokines and myokinins levels in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Regular hemodialysis more than 3 months with 4 hours a time, thrice a week
* Eligible to sign permit

Exclusion Criteria:

* Could not sign permit or do not want to join the trial
* Infection
* Amputation of any one of the lower limb
* Hemodynamic unstable
* Acute myocardial infarction (AMI) in recent 6 months
* Unstable heart condition, such as unstable angina, arrythmia
* Deep vein thrombosis (DVT)
* History of kidney transplantation
* Vascular access over lower limb