cyrilzakka/clinical-trials huggingface dataset:
Impact of Exercise on Immune System and Metabolism in Football Players

Physical exercise, especially of high intensity, is a significant burden to the athlete's body. It should be emphasized that achieving high results in competitive sports requires significant, sometimes extreme, exercise loads during training, which may result in homeostasis disorders, adversely affecting athletes' fitness. Intense and prolonged physical exercise elevates reactive oxygen species, potentially impacting immune function. The mechanism, particularly in high-intensity activities, remains incompletely understood. Excessive oxygen radicals may induce metabolic changes, causing rapid erythrocyte damage and elevated redox-active free iron. This iron increase can be harmful, increasing oxidative stress and immune system activation. The sustained negative impact that may be observed even during post-workout recovery needs further exploration.

"This study aims to explain the impact of an intense exercise test on the immune system, pro-antioxidant balance, and iron metabolism in athletes with varying training levels. The primary questions it seeks to address are:

1. How do athletes' experience and training background influence the immune system's response, pro-antioxidant balance, and iron regulation?
2. Can the level of adaptation to physical exercise (training status) affect the rate of regeneration and the time required to return to pre-exercise homeostasis?"

The study included 40 football players (19 juniors and 21 seniors). The average training experience for junior players was 8.37 years, and for the senior group, it was 16.4 years. All athletes underwent the Multistage 20-meter shuttle run test (Beep Test). Players were informed about the test procedures and additionally motivated by the trainer to exert maximum effort. Each attempt was preceded by a warm-up, consisting of a 5-minute low-intensity jog. The Beep Test was supervised by the Team trainer using a program as a monitoring tool to examine changes in the level of cardio-respiratory fitness across all age groups. Blood samples were collected at rest, before the exercise test, then 1 minute after the end of the exercise test, after 3 hours of recovery, and finally, after 24 hours. Blood was drawn from the antecubital vein, with 12 ml collected each time.

Eligibility Criteria:
Inclusion Criteria:

* Competitive football training for at least 3 years
* Male
* Not taking any medications throughout the study
* Provide voluntary consent for participation in the study

Exclusion Criteria:

* Any healthy problems
Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®

This study aims at assessing the hard and soft tissues remodelling of the alveolar crest after extraction socket managements in the aesthetic areas:

* 3D radiographic evaluation (CT scan) was performed post extraction and 3 months after at the time of implant placement. (Outcomes 1: Hard tissues analyses )
* Impressions, models and 3D analyses of the treated area allowed studying external soft tissue remodeling at different time points after extraction. (Outcomes 2: Soft tissues analyses )


Eligibility Criteria:
Inclusion Criteria:

* Patients needing an extraction in the aesthetic area to be replace with an implant (incisive, canine or premolar)
* Good general health (ASA 1, 2)
* Controlled periodontitis
* No age restriction

Exclusion Criteria:

* Extraction socket with buccal bone defect / buccal bone wall dehiscence
* Smokers \> 10 cigarettes per day
* Immune system disease
* Bone disease or treatment by medicines interfering with bone metabolism
Experiences and Needs of Patients With a High-grade Glioma and Their Caregivers

The purpose of this study is to explore the experiences and needs of patients with a high-grade glioma and their caregivers. Semi-structured interviews with patients and caregivers will be conducted and analysed using Grounded-Theory approach.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Patients with a primary high-grade glioma who are treated with chemo or were treated with chemo
* Caregivers of patients with a primary high-grade glioma who are treated with chemo or were treated with chemo
* Able to be interviewed
* Dutch

Exclusion Criteria:

* Patients with cerebral metastases
* Patients and caregivers who withdraw their informed consent
* Emotionally and cognitive not being able to be interviewed
Incidence, Risk Factors and Endoscopic Retrieval of Proximally Migrated Pancreatic Stents

This study intends to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents.

Endoscopic pancreatic stenting can be used to treat a variety of pancreatic disorders, including chronic pancreatitis-induced pancreatic duct stenosis, pancreatic schizophrenia, pancreatic leakage, pancreatic pseudocyst drainage, and prophylactic pancreatic duct stenting. Postoperative stent migration is one of the complications associated with pancreatic stent placement.

In this retrospective study, more than 9,000 Endoscopic retrograde cholangiopancreatography (ERCP) cases at our center over the past 25 years will be analyzed to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic stent placement under ERCP;
* Pancreatic stent migration found by ERCP;
* Displaced pancreatic stent removal by ERCP technique.

Exclusion Criteria:

* Incomplete ERCP records (e.g., missing stent size information);
* Immediate removal of pancreatic stent following implantation for a variety of reasons.
Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

Hip fracture is one of the most frequently occurred injury in the elderly and usually requires surgical treatment. Malnutrition is common in elderly patients with hip fracture and is associated with worse outcomes. This study is designed to test the hypothesize that, in elderly patients with malnutrition or at risk of malnutrition and scheduled for hip-fracture surgery, perioperative nutritional intervention may reduce early complications and improve long-term survival.

Elderly patients with hip fracture have a high rate of malnutrition. In a cohort study of hip fracture patients aged 70 years or older, 18.8% have malnutrition and 44.6% are at risk of malnutrition. Increasing evidence suggest that preoperative nutritional status has a significant impact on clinical outcomes of elderly patients following surgery. For example, preoperative malnutrition or risk of malnutrition is associated with increased delirium, increased non-delirium complications, prolonged hospital stay, high mortality, and even worse long-term survival after surgery. We speculate that perioperative nutritional intervention may reduce postoperative delirium and improve early and long-term clinical outcomes in elderly hip-fracture patients. The purpose of this study is to observe the effect of perioperative nutritional intervention on early postoperative delirium and complications as well as long-term survival in the patients with malnutrition or at risk of malnutrition who are scheduled for hip-fracture surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥70 years old;
* Hospitalized for hip fracture, scheduled to undergo hip-fracture surgery within 48 hours;
* Classified as malnutrition or at risk of malnutrition according to the short form mini-nutrition assessment (MNA-SF);
* Provide written informed consents.

Exclusion Criteria:

* Pathological fracture;
* History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery;
* Unable to communicate due to coma, severe dementia, or language barrier;
* Unable to eat due to any disease in the gastrointestinal system;
* Severe hepatic dysfunction (Child-Pugh class C), renal failure (requirement of renal replacement therapy), respiratory failure (requirement of respiratory support), cardiac insufficiency (New York Heart Association classification ≥IV), or American Socisty of Anesthesiologists classification ≥IV;
* Preexisting organ injury before surgery (delirium, acute kidney injury, myocardial injury, etc.);
* Other conditions that are considered unsuitable for study participation.
Characterization of the Metabolic Fate of an Oral Arginine Form

The purpose of this study is to compare the metabolic fate of two oral forms of L-Arginine in healthy subjects featuring metabolic syndrome related risk factors

The study is a randomized crossover study including 16 healthy subjects with risk factors for metabolic syndrome and 16 healthy control subjects. According a double crossover design, each subject received two oral forms of L-arginine (A and B) in random order, and participated in a exploration day on the first day of arginine administration and after one week of supplementation with this arginine form. The two weeks of arginine supplementation were separated by a washout period of 2 weeks at least.

Each exploration extended over 24 hours after administration of the first arginine dose. Blood tests were performed at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 h after administration of the first dose. During explorations after the supplementation period, we also collected urine (0, 2, 4, 8, 12, 24 h after the first dose).

Eligibility Criteria:
Healthy subjects with 'Hypertriglyceridemic waist' :

Inclusion Criteria:

* Age between 18 to 60 years old
* Overweight (BMI between 25 and 30 kg/m²)
* 'Hypertriglyceridemic waist' (waist circumference \> 94cm for men or \> 88cm for women and fasting triglyceride levels \> 150 mg/dL)

Exclusion Criteria:

* Obesity (BMI\> 30 kg / m²)
* Cardiac or vascular diseases
* Diabetes
* Thyroid disease
* Systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg
* Tobacco consumption \> 6 cigarettes per week
* Alcohol consumption\> 3 drinks per day
* Any medication (except contraceptive treatment) or dietary supplement intake that could not be arrested more than a week before the first visit for the duration of the study.
* Persons under guardianship
* Pregnancy (positive beta-hCG blood test)
* Positive serology HBsAg AcHbc, HCV and HIV
* Hemoglobin \< 14 g/dl (for men) or \<12 g / dl (for women)
* Participation in a clinical trial within 6 months preceding the study

Healthy control subjects :

Inclusion Criteria:

* Age between 18 to 60 years old
* Normal weight (BMI between 18.5 and 25 kg/m²)
* Waist circumference \< 94cm for men or \< 88cm for women and fasting triglyceride levels \< 150 mg/dL

Exclusion Criteria :

* Cardiac or vascular diseases
* Diabetes
* Thyroid disease
* Systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg
* Tobacco consumption \> 6 cigarettes per week
* Alcohol consumption\> 3 drinks per day
* Any medication (except contraceptive treatment) or dietary supplement intake that could not be arrested more than a week before the first visit for the duration of the study.
* Persons under guardianship
* Pregnancy (positive beta-hCG blood test)
* Positive serology HBsAg AcHbc, HCV and HIV
* Hemoglobin \< 14 g/dl (for men) or \<12 g / dl (for women)
* Participation in a clinical trial within 6 months preceding the study
A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.

This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* Histologically documented CD20+ mature B-cell neoplasm

  * Large B-cell lymphoma
  * Follicular lymphoma
  * Mantle cell lymphoma
  * Chronic lymphocytic leukemia
  * Small lymphocytic lymphoma
* Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;
* ECOG performance status of ≤ 2 (\< 2 in EU countries).

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria:

* Any neoplasm histology not specified in the IC section;
* Active CNS involvement in lymphoma;
* CNS pathology including but not limited to any history of seizure disorder/epilepsy;
* Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy;
* History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS;
* Active and uncontrolled infections;
* Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions

The above is a summary, other exclusion criteria details may apply.
Epidural Magnesium Sulfate for Post-thoracotomy Pain Control

Pain after thoracotomy is very severe and may cause pulmonary complications. Thoracic epidural analgesia has greatly decreased the pain experience and its consequences. However, new ways of decreasing post-operative opioid drugs consumption is an important issue of research. We aim to evaluate the effect of adding epidural magnesium sulfate to bupivacaine and morphine on pain control and the amount of opioid consumption after thoracotomy. Eighty patients undergoing thoracotomy at a tertiary cardiothoracic referral center will be enrolled in a randomized double blind trial. Patients randomly will be allocated in two groups. Bupivacaine (12.5 mg) plus morphine (2 mg) will be administered epidurally for all patients at the end of operation. Patients in group I will be received epidural magnesium sulfate (50 mg) and patients in Group II will be received normal saline as an adjuvant. Visual analog scale (VAS) score and the amount of morphine consumption will be measured during 24 hours post-operation.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical statuses I-III
* Undergoing thoracotomy

Exclusion Criteria:

* Known hypersensitivity to magnesium sulfate
* Renal failure
* Hepatic dysfunction
* Severe obesity
* Psychotic or neurologic diseases
* Currently taking opioid or calcium channel blocker
* AV block degree II or III
* Refused to participate in trial
Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting

The primary objective of this pilot study is to identify and quantify inflammatory and genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history of chronic obstructive pulmonary disease (COPD) undergoing elective coronary revascularization (CABG) to determine the risk of developing post operative respiratory failure. To achieve this objective, this proposal outlines the following specific aims:

Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at the time of intubation immediately prior to surgery and again upon skin closure immediately after the surgical procedure.

Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with post-operative pulmonary complications defined as prolonged mechanical ventilation (\> 24 hours), pneumonia, and/or tracheostomy.

Aim #3. To inform the development and implementation of a large pivotal trial which may impact clinical decision-making during the initial pre-operative outpatient assessment of COPD patients undergoing CABG.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective CABG
* Current diagnosis of COPD
* Ability to provide signed informed consent to participate
* \> 18 years of age

Exclusion Criteria:

* Concomitant valve surgery
* Urgent or emergent coronary surgery
* Current steroid therapy
* Active smoker and/or positive urine co-nicotine
Action of Epigenetic Modifiers in Cystic Fibrosis Treatment

Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4 and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using an air-liquide interface culture of nasals cells from CF patients or controls.


Eligibility Criteria:
General inclusion criteria :

* informed consent
* benefit from disease insurance regimen
* men and women

Inclusion Criteria for CF patients

* 2 severe CF mutations
* age superior or equal to 12

Inclusion Criteria for controls :

* age superior or equal to 18
* no smoker (for 5 years)

General exclusion criteria :

* participation to an other interventionnal study
* subject in exclusion period
* law protected subject
* pregnant and breast fooding

Specific Exclusion Criteria:

* Xylocaine hypersensibility
* Porphyria
* severe hepatic failure
* Epilepsy
* Severe cardiac failure
* local anesthesic contra indication

Specific Control subject Exclusion Criteria:

* respiratory disease
* cystic fibrosis
* acute infection \< 6 weeks
* on treatment
* antibiotic treatment \< 3 months
The Effect of Hypoglycaemia on Brain Lactate Accumulation and Cerebral Blood Flow

Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation, characterized by suppression of hypoglycemic symptoms and lead to hypoglycemia unawareness, which in itself defines a particularly high risk of severe hypoglycemia. Recent evidence suggest a pivotal role for increased brain lactate transport capacity in the pathogenesis of hypoglycemia unawareness. However, there is uncertainty about the magnitude of this effect and whether such excess brain lactate is oxidizes as a glucose-sparing alternative energy source or acts as a metabolic regulator controlling brain glucose metabolism, oxygen consumption and cerebral blood flow.

Objective: The primary objective of this study is to investigate the effect of hypoglycemia on brain lactate accumulation and regional cerebral blood perfusion in humans. The secondary objective is to assess whether this effect is a related to hypoglycemia unawareness or a consequence of T1DM per se.

Hypothesis: The investigators hypothesize that hypoglycemia stimulates lactate transport over the blood-brain barrier leading to cerebral lactate accumulation and that this lactate accumulation is a function of prior hypoglycemic exposure frequency contributing to clinical hypoglycemia unawareness. Furthermore, the investigators expect that this effect of hypoglycemia on brain lactate accumulation is related to changes in cerebral blood flow (CBF).


Eligibility Criteria:
Inclusion criteria for healthy subjects

* Age: 18-50 years
* Body-Mass Index: 18-30 kg/m2
* Blood pressure: \<160/90 mmHg

Inclusion criteria T1DM patients with normal hypoglycemic awareness

* Diabetes duration ≥ 1 year
* Age: 18-50 years
* Body-Mass Index: 18-30 kg/m2
* HbA1c: 42-75 mmol/mol (6-9%)
* Outcome Clarke questionnaire: 0-1
* Blood pressure: \<160/90 mmHg

Inclusion criteria T1DM patients with hypoglycemia unawareness

* Diabetes duration ≥ 1 year
* Age: 18-50 years
* Body-Mass Index: 18-30 kg/m2
* HbA1c: 42-75 mmol/mol (6-9%)
* Outcome Clarke questionnaire: \>3
* Blood pressure: \<160/90 mmHg

Exclusion criteria for healthy subjects

* Inability to provide informed consent
* Presence of any medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event or anxiety disorders
* Use of any medication, except for oral contraceptives
* MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)

Exclusion criteria for all T1DM patients

* Inability to provide informed consent
* Presence of any other medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event, anxiety disorders, or complications of T1DM (including neuropathy and retinopathy)
* Use of any other medication than insulin, except for oral contraceptives or stable thyroxine supplementation therapy
* MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
The MRI-based Evaluation of Safety and Efficacy of EVT and SMT: A Retrospective, Multicenter Study

Acute Basilar Artery Occlusion (ABAO), a condition with a high risk of mortality or disability (up to 80%). The safety and efficacy of endovascular thrombectomy (EVT) in ABAO remains uncertain due to inconsistent evidence from random controlled trials (RCTs).

Recent studies have explored the use of MRI in ABAO, this study aims to assess the efficacy and safety of EVT and standard medical therapy (SMT) in the treatment of ABAO within 24 hours of onset. It also aims to explore the feasibility and prognostic value of MRI-based assessment of ABAO infarction using AI image analysis software.


Eligibility Criteria:
Inclusion Criteria:

1. Preliminary diagnosis of posterior circulation ischemic stroke based on clinical symptoms or imaging examinations.
2. Confirmation through CTA/MRA/DSA that there is occlusion of the basilar artery or the V4 segment of the vertebral artery leading to functional occlusion of the basilar artery.
3. Age 18 years and older.
4. Symptom onset within 24 hours.
5. Having a baseline MRI evaluation, including at least DWI and T2 FLAIR sequences (baseline MRI for the EVT group before the operation; baseline MRI for the SMT group within the treatment window (within 4.5 hours of onset) for thrombolytic patients before or during the thrombolysis process should initiate as early as possible; baseline MRI for the SMT group for extended treatment window patients (between 4.5 hours to 12 hours of onset) should initiate as early as possible).

Exclusion Criteria:

1. mRS score ≥ 3 before onset;
2. Significant neuroimaging changes such as cerebral hemorrhage, cerebellar mass lesion, acute hydrocephalus, etc., are present;
3. Lack of follow-up results within 90 days after operation;
4. Life expectancy \< 3 months;
5. Baseline imaging and crucial clinical data are missing;
6. Special cases involving pregnancy and lactation;
7. Severe systemic diseases or advanced cancer that may potentially interfere with the prognosis;
8. Allergic reactions to contrast agents or nickel-titanium alloys;
9. Currently participating in other clinical trials;
10. Pre-existing neurological disorders or psychiatric conditions that could affect the assessment of the disease.