cyrilzakka/clinical-trials huggingface dataset:
Marathon, Genetics, Inflammation and the Cardiovascular System: MAGIC-Trial

The purpose of the study is to determine the myocardial function and vascular adaptation after strenuous exercise in association with genotype/polymorphisms. We aim to investigate the effects of extreme endurance exercise on the cardiovascular system. Furthermore, the role of the inflammatory response and adaptive mechanisms of the vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being investigated.

Regular exercise leads to an improvement of cardiovascular risc factors in patients with coronary heart disease, atherosclerosis and metabolic disorders. Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.

We aim to define the critical role of inflammatory markers and cardiovascular risc factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.

Diagnostic tools include measurements of augmentation index (AIx), arteriolar-venular ratio (AVR) and, for the first time, 2D and 3D echocardiographic measurements such as TDI-imaging and speckle tracking. Inflammatory markers include c-reactive protein (CRP), interleukins and tumor necrosis factor. Additionally, cardiovascular markers are measured. All variations are analysed on the basis of genotype characteristics/polymorphisms.

Eligibility Criteria:
Inclusion Criteria:

* men aged 30-60 years

Exclusion Criteria:

* manifested heart disease
* insulin dependent diabetes mellitus
* multi drug therapy
* GFR\<60ml/min.
Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes

Tricuspid regurgitation (TR) is a common complication following cardiac implantable electronic device (CIED) implantation, with severe TR being associated with increased rates of heart failure hospitalization and all-cause mortality, significantly impairing patients' quality of life. With technological advancements, physiological pacing modalities have demonstrated superior clinical efficacy and safety profiles compared to conventional pacing methods.

This study aims to evaluate predictors of adverse outcomes and TR progression in CIED recipients under different pacing modalities, thereby providing clinical guidance for high-risk patients.

This retrospective study analyzed patients undergoing pacemaker implantation from January 2015 to March 2025, stratified by pacing modality (right ventricular/conduction system/biventricular pacing) and TR progression (worsened \[≥1-grade increase\] vs non-worsened TR).

The protocol included: (1) 3D echocardiographic assessment of TR mechanisms, (2) quantitative fluoroscopic analysis of lead parameters (tension, mobility, angulation), (3) multivariable regression evaluating pacing modes and TR progression on clinical outcomes, and (4) documentation of device-related complications (lead dislodgement/infection) and heart failure rehospitalization.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients
2. Patients with an implantable electronic heart device (CIEDs)
3. The patient underwent pacemaker implantation at Qianfoshan Hospital between 2015 and 2025

Exclusion Criteria:

1. Patients with severe tricuspid regurgitation or those who have undergone tricuspid valve surgery or interventional treatment prior to pacemaker implantation
2. Patients with severe valvular heart disease, congenital heart disease, or arrhythmias
3. Patients with single-chamber pacemakers or poor images
Treating Alzheimer's and Dementia With D-ribose

To study the effectiveness of d-ribose in treating Alzheimer's and Dementia

Clinical experience and the pathophysiology of Alzheimer's, including neuronal insulin resistance, suggests that ribose improves clinical outcomes. This study will add ribose 5 gm 3 X day for 8 weeks to monitor outcomes in a pilot study.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Alzheimer's and/or dementia with a Mini Mental Status Exam ( MMSE) score over 12 or being ambulatory and able to travel outside the home with assistance.
* Must have a caregiver living with them.

Exclusion Criteria:

* Overt and severe causes of secondary dementia such as metastatic brain cancers, or severe overt infectious encephalopathies or severe autoimmune illness.
* Also, severe life threatening illnesses which would make them unlikely to be alive after 6-12 months.
HeartTrends Heart Rate Variability (HRV) Algorithm for the Diagnosis of Myocardial Ischemia

The investigators intend to prospectively enroll consecutive patients, without known ischemic heart disease, referred by their physician for routine exercise MPI at a tertiary care center.

Prior to the MPI (nuclear stress test), eligible and consenting patients will undergo a one-hour period of Holter ECG digital recording. Application of ECG electrodes will be performed by medical technicians following standard recommendations, utilizing approved Holter device \& stickers. The Holter ECG data will be used for the offline heart rate variability (HRV) analysis by the HeartTrends device.

Immediately following data acquisition, all patients will undergo an exercise MPI according to accepted clinical practice guidelines.

Following the MPI, there will be no interference with patient management, which will be conducted by the patients' treating physicians according to current guidelines, unaware of HRV results.

Analysis of recorded ECG data for HRV will be performed blinded to the EST and MPI results, by HeartTrends device.

The results of the HRV tests will not be available to treating physicians and will not be used to guide patient management. Patients will be followed for 6 months for the occurrence of coronary interventions and MACE, defined as: death, myocardial infarction, unstable angina, or any coronary revascularization.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21
* Referral for exercise MPI by treating physicians
* Willing and able to provide written informed consent

Exclusion Criteria:

* Established ischemic heart disease
* Atrial fibrillation or flutter
* Acute Coronary Syndrome
* Cardiac Pacemaker
* Clinical diagnosis of heart failure
* Moderate or severe COPD
* Active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
* Any illness that might reduce life expectancy to less than 1 year from screening
* Left bundle branch block (LBBB), significant intra-ventricular conduction delay (IVCD) or significant (\>1mm) ST deviations on baseline ECG
* Inability to perform an exercise stress test (i.e. orthopedical or neurological limitations)
* Any significant established myocardial or valvular disease
Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy

The recent study suggested that oxidative stress resulting from increased production of reactive oxygen species (ROS) plays a crucial role in the development of diabetic complications. The researches aim to monitor the level of oxidative stress of patient in different stage of diabetic nephropathy before and after insulin pump therapy.

Worldwidely, about 30% of Type 1 Diabetes Mellitus (T1DM) and 20%-50% of T2DM patients suffered diabetic nephropathy (DN). Oxidative stress resulting from increased production of reactive oxygen species (ROS) plays a crucial role in the development of diabetic complications. Insulin pump therapy is better than subcutaneous injection in terms of the drug safety and effectiveness. The researches aim to monitor the level of oxidative stress of patient in different stage of diabetic nephropathy before and after insulin pump therapy.

Eligibility Criteria:
Inclusion Criteria:

Diabetic patients with fasting plasma glucose (FPG) ≥10mmol/l and/or 2 hours' plasma glucose (2hPG) ≥15mmol/l.

Exclusion Criteria:

Diabetic patients who

1. using antioxidant drugs within one month;
2. accompanied with acute and chronic severe complications, fever, malignant tumor, nephritis, congestive heart failure.
3. accompanied with diabetic ketosis, ketoacidosis, severe hypoglycemia, hyperosmolar hyperglycemic state;
4. with other endocrine diseases, autoimmune diseases, or connective tissue diseases;
5. having history of infection within 1 month;
6. having drug or alcohol dependence;
7. severe hypoxia and stress state (e.g., cardiovascular events, trauma, surgery, and consumptive disease, etc.)
Impact of Explanation Given to Parents on Rate of Post-partum Influenza Vaccination

The aim of this study is to determine whether an explanation to parents for the need for post-partum influenza vaccination will influence their compliance.


Eligibility Criteria:
Inclusion Criteria:

* All parents discharged from well-baby nursery

Exclusion Criteria:

-
MyPatientPal: An App to Help Patients Manage Their Cancer Care

MyPatientPal was developed in collaboration with both patient and oncologist stakeholders, is designed to facilitate such patient self-management through the daily reporting of side effects and medications.

MyPatientPal is a patient app that is designed to help patients track and manage treatment side effects and medication adherence on a daily basis. Side effects (e.g., pain, fatigue, diarrhea, nausea) can be physically and emotionally debilitating, and when uncontrolled, can cause treatment complications, resulting in unscheduled care costs, patient out-of-pocket costs, and delays or discontinuation of treatment. The app allows personalization of daily entries such that patients can select the specific medications and dosage and side effects (using items from the NCI Common Terminology Criteria for Adverse Events) that they and/or their providers want to track. A charting feature provides an easy-to-read display of patients' daily reports, summarizing the intensity and frequency of side effects and medication use either by week or by month. These reports can also be printed out and shared with providers.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of any solid tumor cancer
* Be starting treatment using an oral cancer therapeutic agent
* Be able to speak, read, and write English
* Willing and able to use their smartphone to use MyPatientPal

Exclusion Criteria:

* Patients with cognitive or perceptual disturbances
Ultrasound Versus Magnetic Reseonance Imaging(MRI) in the Assessment of Anterior Knee Pain

Anterior knee pain , often known as patellofemoral pain syndrome (PFPS), is a prevalent orthopedic ailment. It usually happens while you're bending your knees. It can affect people of all ages, although it is most common among teenagers, young adults, and athletes .

The actual etiology of anterior knee pain might be complicated, encompassing a variety of conditions; it causes disability, discomfort and a negative impact on the quality of life

. A number of diagnostic techniques, including plain radiography, computed tomography, MRI, arthroscopy and ultrasound are used to identify the pathologies causing anterior knee pain. Arthroscopy, though accurate, is invasive and can cause complications. Palin radiographs and computed tomography expose patients to radiations


Eligibility Criteria:
Inclusion Criteria:

* Adults who presented by knee pain , limitation of movement at knee.

Exclusion Criteria:

* Knee trauma, non-cooperative patients and those who refuse to participate, contraindications to magnetic resonance imaging, such as patients with cardiac pacemakers, metallic plates, and claustrophobia.
Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome

This study aims to determine the Health Related Quality of life (HRQOL) (the physical, mental, emotional and social functioning) of patients with cubital tunnel syndrome following anterior intramuscular transposition, after one year.

As there are many different surgical procedures to address cubital tunnel syndrome, HRQOL will be used to determine if anterior intramuscular transposition provides patients with positive outcomes. To measure HRQOL 3 specific scales will be administered:

1. A generic scale, the Short Form-36
2. A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE)
3. A utility scale, the EuroQOL, five dimension questionnaire

These scales are widely reported in the literature, are valid, reliable and easy to fill out. Using these scales we can determine HRQOL as well as Quality Adjusted Life Years, which, allows us to do a cost-utility analysis (economic evaluation) on this specific procedure.

Patients will be asked to fill out the above mentioned questionnaires, as well as perform 2 performance tests (grip strength, and a moving 2-point discrimination test) at the following time points:

1. 1 week prior to surgery
2. 1 day prior to surgery
3. 3 months post surgery
4. 6 months post surgery
5. 12 months post surgery

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cubital tunnel syndrome confirmed with Electromyography (EMG) testing or Ultrasound imaging
* Ability to comprehend English and complete health related quality of life questionnaires
* Willing to provide informed consent
* Age \> 18 years
* Not pregnant

Exclusion Criteria:

* Prior ipsilateral cubital tunnel release
* Evidence of symptomatic clinical double crush syndrome confirmed by EMG/Nerve Conduction Study (NCS)
* Patients with rheumatoid arthritis, connective tissue disorder, tenosynovitis, or diagnosed neurological condition that could confound the assessment of health-related quality of life with regard to the affected arm and hand
The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection

Recently, the HS has been used in head and neck surgery as an alternative to conventional hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have been published on the evidence of its safety in ND, especially in radical ND. Researchers investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND), while using conventional hand-tied ligation to a minimum, in terms of operating time, blood loss, drainage and complications.


Eligibility Criteria:
Inclusion Criteria:

* preoperative diagnosis of head and neck squamous cell carcinoma
* surgery as initial treatment

Exclusion Criteria:

* cases in which the ND specimen could not be separated from the primary tumor
* past history of neck surgery
Comparative Study Between Conventional Crystalloid Cardioplegic Solution With Modified Del Nido Cardioplegia

Mitral valvuloplasty for correction of chronic mitral regurgitation carries a lower operative mortality and morbidity and improved long-term survival than does mitral valve replacement. Unfortunately, mitral valvuloplasty is not possible in all patients with chronic mitral regurgitation because of unfavorable pathology or lack of experience with this technique

Cardioplegia is a fundamental component in providing heart protection, limiting metabolic activity and increasing the myocardium's capacity to resist ischemia for prolonged periods, thus being essential for good surgical outcomes.

Numerous cardioplegia solutions exist with different compositions to provide sufficient myocardial protection. However, there is no standard for the optimal or ideal composition and delivery technique. Cardioplegia solutions are crystalloid or blood-based solutions with various chemical compounds.

Despite improvements in myocardial protection, prosthetic valves, surgical techniques, and postoperative care, the operative mortality and morbidity of mitral valve replacement for chronic mitral regurgitation remains high in comparison with other commonly performed heart operations.

The timing of the administration of cardioplegia is extremely important in terms of preventing myocardial dysfunction. Conventional multidose cardioplegias should be repeatedly administered in every 15 to 20 min. Frequent interruption of the surgical process, even for a short time, before each cardioplegia delivery leads to a loss of time during open heart surgery, where time is extremely important, and disrupts the coherence of the operation and the surgical concentration.

Crystalloid cardioplegic solutions achieve cardioplegic arrest through inhibition of either fast-acting sodium channels or calcium-activated mechanisms. Hyperkalemia can be used to inhibit the fast-acting sodium channels as it is in the St.Thomas Hospital solution and its modifications.

Eligibility Criteria:
Inclusion Criteria:

- Patients scheduled for elective Mitral regurge replacement Surgery with normal Coronaries

Exclusion Criteria:

1. Patients with chronic renal disease (previous medical diagnosis or serum creatinine greater than 1.5mg/dL)
2. Left ventricular ejection fraction less than 50%.
3. Previous cardiac surgery
4. Patient with BMI \> 30
5. Severe psychiatric illness
6. Inability or unwillingness to give informed consent for participation
A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

The main purpose of this study is to evaluate the safety and efficacy of LY3541860 in adult participants with multiple sclerosis that gets worse and gets better. The study will last about 9 months with additional 6 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Participants must meet criteria for relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis based on the 2017 revision of the McDonald diagnostic criteria (Thompson et al. 2018) with a relapsing course (RMS) activity according to Klineova and Lublin 2018.
* Participants must have 1 of these:

  * at least 1 documented relapse within the previous year
  * at least 2 documented relapses within the previous 2 years, or
  * at least 1 active GdE brain lesion on an MRI scan in the past 180 days prior to screening.
* Have an Expanded Disability Status Scale (EDSS) score of less than or equal to (≤) 5.5 at screening and randomization.

Exclusion Criteria:

* Have had a diagnosis of:

  * primary progressive multiple sclerosis (MS) according to the 2017 revision of McDonald diagnostic criteria (Thompson et al. 2018), or
  * nonactive secondary progressive MS ( Klineova and Lublin 2018).
* Meet criteria for neuromyelitis optica spectrum disorder (Wingerchuk and Lucchinetti 2022).
* Have a history of clinically significant central nervous system (CNS) disease.
* Have had a confirmed relapse with systemic corticosteroid administration \<30 days prior to randomization.
* Have more than 20 active GdE brain lesions on screening MRI scan.
* Have received any of these medications or treatments.
* Have a current or recent acute, active infection.
* Have current serious or unstable illnesses.
* Have any other clinically important abnormality at screening or baseline.
Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application

In a retrospective observational study, critically ill COVID-19 patients admitted to the ICU with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated (ethics application nr. 129/22 of the ethics commssion of the university Ulm.

According to the recommendations, IgG seronegative SARSCoV2-Spike antibody (\< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP \> 75 mg/l or IL-6 \> 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight. 28-day mortality and 30-day time course of leukocyte counts and serum concentrations of C-reactive protein (CRP), procalcitonin (PCT), interleukin 6 (IL-6) and ferritin in 4 patient groups, i. e., treated without (N) or with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T), were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COVID-19
* CoV-2 delta-variant
* critically ill patients
* ICU

Exclusion Criteria:

* tuberculosis
* active hepatitis
* HIV
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine

The primary objective was to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have never received any meningococcal vaccine (naïve subjects) to serve as a control group. In addition, the response of a booster dose at 60 months was evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Children eligible to be enrolled in the study are those whose parents provide written informed consent, and are in generally good health based on the clinical judgment of the investigators.
* Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study (NCT00474526).
* Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.

Exclusion Criteria:

* Serious, acute, or chronic illnesses are reasons for exclusion.
* Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
* Subjects who have received any meningococcal vaccine since birth (Groups 3 \& 4 -naive) or last study dose in V59P14 (NCT00474526) trial (Groups 1 \& 2 - follow on).
Effects of a Health Intervention on Fear of Hypoglycemia

To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.

In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on BCW theory given on top of regular diabetes health education) and a control group (regular diabetes health education), with a 4-week intervention period and a 8-week follow-up period, for a total of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus;
* Age ≥18 years;
* Duration of diabetes mellitus ≥1 year;
* FoH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS);
* Patients who have the ability to listen, read, write, walk, and cooperate to complete the study;
* Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate;
* Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

* Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc;
* Patients with comorbid psychiatric diseases or taking psychotropic drugs;
* Patients who have recently or are participating in other studies on similar topics.
Progress Pediatric Study

The purpose of this study is to study the HIV disease progression in HIV-infected Thai children.

This is a multicenter, observational cohort study. HIV-infected children from 5 institutions are followed to assess HIV disease progression: 1. Bamrasnaradura infectious disease institute,2. Faculty of Medicine Siriraj Hospital, Mahidol University, 3. Chiangrai Prachanukroh Hospital, 4. Sanpatong Hospital and 5. HIV-NAT, Thai Red Cross AIDS Research Center.

Eligibility Criteria:
Inclusion Criteria:

1. age \< 18 years old
2. Have confirmed HIV infection (ELISA,HIV-DNA PCR,HIV-RNA PCR)
3. Signed consent form

Exclusion Criteria:

1. Hospitalization
2. Emergency case
3. Incomplete Medical Record