cyrilzakka/clinical-trials huggingface dataset:
Safety of Cardiac Pacemakers in 1.5T Tesla MRI

To evaluate short-term and long-term effects by MR imaging on the technical and functional status of Medtronic pacemakers.

The presence of a cardiac pacemaker (PM) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. In 2002 there were approximately 2.4 million patients in the US with cardiac PM, and this number is growing by 80,000 annually. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement 1, demonstrating the need for a practical and safe approach for performing MRI on PM patients.

The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included exclusion of pacemaker dependent patients and those requiring imaging of the thorax, restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and PM reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of PM patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a 3-month follow-up to evaluate long-term effects.

Eligibility Criteria:
Inclusion Criteria:

* Urgent need for an MRI examination
* Presence of a Medtronic PM system manufactured between 1993 and 2004
* Stable pacemaker physical parameters

  * Battery voltage \> 2.7 V
  * Battery impedance \< 2000 Ohm
  * Battery estimated remaining lifetime \> 6 months
  * Lead impedances 200-2000 Ohm
* Stable pacing parameters

  * Pacing capture threshold \<2.5V at a pulse duration of 0.4ms
  * Sensing \> 5mV
* Minimum 3 months since pacemaker and lead implantation

Exclusion Criteria:

* PM system manufacturer other than Medtronic
* History of ventricular tachycardia (VT) or ventricular fibrillation
* Unstable angina
* Myocardial infarction within the previous 3 months
* Cardiothoracic surgery within the previous 3 months
* Complete atrioventricular block
* Absolute pacemaker dependence

  * Heart rate \< 40 bpm or
  * Heart rate \< 60 bpm producing neurological symptoms
* Presence of an abdominal pacemaker with lead length \> 70 cm
* Presence of MRI incompatible bioimplants or other MRI incompatible materials
* Request for an MR examination of the chest, including the heart, breasts and thoracic spine
The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function

Low level transcutaneous vagus nerve stimulation (LLTS) involves delivery of electrical impulses transcutaneously at the auricular branch of vagus nerve and it has been shown to have anti-inflammatory and anti-arrhythmic effects. In previous studies from our laboratory, we found that LLTS significantly suppressed atrial fibrillation (AF) inducibility and decreased AF duration. The anti-arrhythmic effects of LLTS were similar to those delivered to the cervical VN trunk. LLTS for just one hour significantly shortened the AF duration and decreased inflammatory cytokines. We have also shown that LLTS leads to favorable heart rate variability (HRV) changes and cardiac mechanics in patients with diastolic dysfunction. These results support the use of LLTS as a novel non-pharmacological, non-ablative treatment modality for AF and possibly other inflammatory conditions. However, the optimal stimulation parameters of LLTS remain to be determined.

In this study, we aim to examine the effect of 2 different frequencies (5Hz and 20Hz) and 2 different amplitudes (50% below the pain threshold and 1mA below the pain threshold) of LLTS on heart rate variability with deep breathing (HRVdb), mental arithmetic stress test (MAST), frequency domain measures of heart rate variability (HRV) and brain stem evoked potentials (BSEVP) in healthy volunteers and patients with AF or heart failure with preserved ejection fraction (HFpEF). HRV is a marker of vagus nerve activity and can be easily measured by software calculating the distance between consecutive R waves on the ECG. BSEVP are a surrogate for the central projections of the vagus nerve. Patients will be randomized into 4 groups in a 2x2 factorial design. LLTS will be delivered through a transcutaneous electrical nerve stimulation (TENS) device for 15 minutes. HRVdb, HRV and BSEVP will be measured before and after LLTS and compared.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients older than 21 year old
2. Healthy volunteers free from diagnosis of AF, heart failure, coronary artery disease or diseases that affect the autonomic nervous system.
3. Patients with Paroxysmal Atrial Fibrillation
4. Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)

Exclusion Criteria:

1. Recent (\<6 months) stroke
2. Recent (\<6 months) myocardial infarction
3. Heart failure (NYHA class III or IV)
4. Left ventricular ejection fraction \<50%
5. Recurrent vaso-vagal syncopal episodes
6. Unilateral or bilateral vagotomy
7. Pregnancy or breast feeding
8. Uncontrolled diabetes or hypertension
9. Inability or unwillingness to understand and/or sign informed consent
10. Any serious disease that affects autonomic nervous system function
11. Any medications that affect autonomic nervous system function
25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders

Evaluation of 25- Hydroxyvitamin D levels in pregnant women in Austria and potential related disorders

Hypothesis:

Austrian pregnant women are Vitamin D deficient Present vitamin D supplementation in pregnancy is insufficient Vitamin D deficiency is associated with pregnancy related disorders like preeclampsia


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years
* informed consent

Exclusion Criteria:

* chronic hypertension
* kidney disease
* lupus erythematodes
* diabetes mellitus
* malabsorption syndrome
* hyperparathyroidism
* surgery on the thyroid gland
Pulsed-Field Ablation Vs. Radiofrequency Ablation CombIned with Vein of Marshall Ethanol Ablation on Mitral Isthmus Block and Clinical Outcomes in Persistent Atrial Fibrillation

Atrial fibrillation (AF) is one of the most common clinical arrhythmias, and catheter ablation serves as a critical therapeutic approach. For persistent atrial fibrillation, several proposed ablation strategies-including the 2C3L technique, BOX lesion sets, and substrate modification-remain highly controversial regarding long-term success rates. Multiple studies suggest that linear ablation beyond pulmonary vein isolation (PVI) often fails to achieve durable block due to incomplete ablation lines, which significantly contributes to postoperative recurrence of atrial arrhythmias.

In recent years, electrophysiologists have explored various methods to improve mitral isthmus (MI) ablation, such as combined endo-epicardial ablation and radiofrequency ablation (RFA) combined with Marshall vein alcohol ablation. While RFA combined with anhydrous alcohol injection into the Marshall vein enhances MI block rates, it is associated with prolonged procedure time, unpredictable ablation zones, and higher complication risks (e.g., coronary artery spasm, pericarditis).

Pulsed field ablation (PFA), an emerging non-thermal ablation technology, offers potential advantages such as tissue selectivity, shorter procedure time, and fewer complications. Studies report that RFA achieves near 100% immediate block rates; however, there is a lack of sufficient comparative studies on the efficacy and safety between these two ablation approaches. This study aims to compare the clinical outcomes and safety profiles of PFA versus RFA combined with Marshall vein alcohol injection in patients with persistent AF.


Eligibility Criteria:
Inclusion Criteria:

1. Persistent atrial fibrillation;
2. Ejection fraction \>30%;
3. NYHA functional class I-III;
4. Left atrial diameter \<55 mm on echocardiography;
5. Signed informed consent form;

Exclusion Criteria:

1. Pregnant or lactating women;
2. Patients with a life expectancy of less than 2 years due to non-cardiovascular factors;
3. Uncontrolled hyperthyroidism, severe liver or kidney dysfunction;
4. History of atrial fibrillation ablation;
5. History of heart transplantation, complex congenital heart disease, or rheumatic heart disease;
6. Contraindications to contrast agents, radiofrequency ablation, antiarrhythmic drugs, or anticoagulants;
7. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular 8.accident within 12 weeks prior to enrollment;

9.Other conditions deemed unsuitable for participation by investigators; 10.Participation in other clinical trials.
Nutritional Intervention With Table Olives in Healthy Volunteers

Olives and olive oil are typical components of the Mediterranean diet being part of its cultural and gastronomic heritage. Since ancient times, olives have been used either for both, oil extraction or whole fruit consumption as table olives. Olive oil stands out from both the nutritional and the health point of view. However, the effect of table olives consumption remains almost unknown. The beneficial properties of olive oil have been initially ascribed to the high concentration of oleic acid. Nowadays, these positive effects have been attributed also to minor compounds such as polyphenols or pentacyclic triterpenes. Table olives contain a higher amount of both polyphenols and pentacyclic triterpenes than their oil, with the same healthy fatty acid profile. Therefore, the present intervention aims at investigating the pharmacokinetic of polyphenols and pentacyclic triterpenes after a single olive intake as well as the assessment of the effect of the consumption of olives during 30 days on the overall health status playing particular attention to the anti-inflammatory, antioxidant and cardiovascular biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 19 and 30 kg/m2.
* Healthy on the basis of physical examination and routine biochemical and hematological laboratory determinations.
* Free acceptance to participate in the study by obtains signed informed consent.

Exclusion Criteria:

* Smoking.
* Alcohol or drug abuse.
* Heavy consumer of stimulating beverages (\>5 coffees, teas, chocolate or cola drinks per day) and grapefruit juice.
* Background of allergy, idiosyncrasy or hypersensitivity to drugs.
* Intake of any medication within 2 weeks prior taking the study intervention (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor within 3 months before the drug administration.
* Positive serology for hepatitis B, C or HIV.
* Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
* Having undergone major surgery during the previous 6 months.
* Pregnancy or lactation status (if applied).
* Participation in another clinical trial during the 3 months preceding the drug administration.
* Donation of blood during the 4 weeks preceding the drug administration.
* Acute illness four weeks before drug administration.
Feasibility of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention Deficit Disorder (ADD).

This study aims at combining imaging techniques and clinical evaluations to assess clinical change as well as brain changes that occur as a result of brain stimulation in adult attention deficit disorder.

This study will use clinical measures and cognitive tasks covering 3 different functional domains during functional magnetic resonance imaging (fMRI), ElectroEncephaloGram (EEG) and Ultrasound tagged near infrared spectroscopy (UT-NIRS), to assess functional brain changes as a result of a treatment protocol with Transcaranial direct current stimulation (tDCS) in adults suffering from attention deficit disorder (ADD).

Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 18-65(male and female)
2. Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV
3. Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.
4. Gave informed consent for participation in the study
5. If referred by the treating psychiatrist, he or she approves of the subjects participation in the study

Exclusion Criteria:

1. Suffering from other diagnosis on axis 1
2. History of drug or alcohol abuse during the last year
3. Inability to achieve satisfying level of communication with the subject
A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)

The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold:

* Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD
* Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* History of ASCVD

Exclusion Criteria:

* Participants known to be currently receiving investigational drug in a clinical study
* Participants with a diagnosis of end-stage renal disease or requiring dialysis
* Participants who have received lipoprotein apheresis to reduce Lp(a) within 3 months prior to enrollment
(MitraClip in Non-Responders to Cardiac Resynchronization Therapy)

Functional mitral regurgitation (FMR) is a common finding in patients with dilated cardiomyopathy and reduced left ventricular ejection fraction (LVEF). The presence of a relevant FMR (grade ≥2) is associated with a higher morbidity and mortality. Cardiac resynchronization therapy (CRT) has been shown to be effective in patients with dilated cardiomyopathy and reduced LVEF. In selected patients, CRT has been linked to clinical improvement and reduced mortality. Importantly, 38% of patients with clinical indication for CRT present moderate or severe (FMR). Although FMR might be reduced after CRT, the persistence of a relevant FMR (≥2) after CRT ranges between 40% and 50% and is an independent predictor of no clinical response. In these patients, surgical FMR correction is frequently turned down as a result of a high surgical risk. Percutaneous repair of the mitral valve with the MitraClip system has demonstrated promising results in patients with dilated cardiomyopathy and reduced LVEF5. In a cohort of patients with no response to CRT and FMR ≥2, Auricchio et al showed significant clinical improvement with LVEF recovery and reduction in left ventricle (LV) volumes after MitraClip. The absence of randomization, the retrospective nature of the study and the subsequent selection biases were however major limitations that impeded solid conclusions. The objective of the present study is to assess the efficacy and safety of the MitraClip system in non-responders to CRT and FMR ≥2.

STUDY HYPOTHESIS:

In patients with no response to CRT and significant FMR (grade ≥2, 100%), the MitraClip system will be associated with improved functional class, LVEF recovery and reduced LV volumes. To our knowledge, no registered randomized studies with a similar design are being conducted.

MAIN OBJECTIVE:

To compare the efficacy and safety of optimal medical treatment and MitraClip versus optimal medical treatment alone (control) in non-responders to CRT and symptomatic FMR ≥2.

Eligibility Criteria:
Inclusion Criteria:

1. CRT implanted between 6 months and 5 years before inclusion.
2. Absence of clinical response to CRT defined by baseline NYHA 3 or NYHA 2 with a hospital admission for HF within the last 12 months.
3. Adequate CRT therapy (correct stimulation in \>98% heart beats).
4. Correct position of the cardiac leads.
5. Patients with atrial fibrillation will be included but balanced in both groups (the presence of AF is and independent factor of clinical response).
6. Wide QRS (\>0.12) and LBBB pre-CRT.
7. LVEF 15-40% (as a surgical risk criteria).
8. Left ventricle end-diastolic diameters \<75 mm (as anatomical criteria for MitraClip feasibility).

Exclusion Criteria:

1. Severe Renal Insufficiency (DFGe \<30).
2. Life expectancy \< 1 year.
3. Anatomical contraindication for MitraClip (in order to avoid selection biases, all patients must be Mitraclip candidates).
4. Hemodynamic instability before inclusion defined by SBP \<70 mmHg or the need of inotropic treatment within the previous 3 months.
5. Inadequate treatment compliance or difficult follow-up.
The Long Term Outcome of Varus Derotational Osteotomy for Legg-Calvé-Perthes' Disease

Background: Varus derotation osteotomy (VDRO) is one of the most popular surgical treatments for Legg-Calvé-Perthes disease yet its long term results have not been assessed. Our purpose was to determine the long term clinical and radiographic outcomes of these patients.

Methods: Forty patients (43 hips) who had undergone VDRO for LCPD who participated in a long term follow-up study a decade ago were approached for the present study.

All patients were treated in our institution during 1959 to 1983 with proximal VDRO.

The patients were invited to for a medical interview and a physical examination. They were also asked to fill out questionnaires and to provide or undergo a standing anteroposterior (AP) pelvic and a lateral hip radiographs during the visit.

Patients were asked to self-grade their hip pain as none, mild, moderate or severe and to grade their back pain using the Visual Analogue Scale (VAS) between 0-10. Details regarding daily function, physical activity, work status and family history were obtained. All participants completed the Harris Hip Score (HHS) with a maximum score of 100 and the Short Form-36 which is composed of 8 sections and has a maximum score of 100.

The physical examination included an assessment of the hip range of motion, leg length discrepancy and the presence of a Trendelenburg sign.

Radiographic parameters evaluated were the Tonnis grade (with a score between 0-3), head size ratio, and the center-edge (CE) angle.


Eligibility Criteria:
Inclusion Criteria:

* All patients were treated in our institution during 1959 to 1983 with proximal VDRO and were examined a decade ago

Exclusion Criteria:

-
FMT for Post-infectious IBS

Considering that PI-IBS is brought on by infection and gut microbiota may be associated with the onset of symptoms, the modification of altered gut microbiota with nonabsorbable antibiotics such as rifaximin-α or probiotics is often employed as first-stage treatment. Research in recent years has also shown the potential benefits of fecal microbiota transplantation (FMT) for IBS, which is the replacement of a sick recipient's gut microbiota with fecal material from a healthy donor. Even though the only officially approved indication for FMT at this time is recurrent Clostridium difficile infection, the effectiveness of FMT is nevertheless being studied for the treatment of other gastrointestinal and non-gastrointestinal pathologies including IBS. To date, several controlled and uncontrolled studies have been conducted to study the effectiveness of FMT for IBS, and most of them have demonstrated positive results. The investigators have not come across studies devoted to the study of the effectiveness of FMT in patients with PI-IBS in the available literature. So, the aim of the current study was to conduct single-centre, randomized clinical trial to assess the safety, clinical and microbiological efficacy of FMT in patients with PI-IBS.


Eligibility Criteria:
Inclusion Criteria

* age 18-65 years
* PI-IBS diagnosis in accordance with the Rome IV criteria
* moderate-severe disease activity (as determined by an IBS-Symptom Severity Score ≥175)
* normal appearing colon on colonoscopy with biopsy that did not reveal pathology
* signed inform consent.

Exclusion Criteria:

* systemic disease, immunodeficiency, or previous treatment with immunomodulators;
* pregnant or breastfeeding;
* previous surgery on the abdominal cavity, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
* severe current disease (hepatic, renal, respiratory, or cardiovascular);
* probiotic or antibiotic use within 8 weeks prior to study initiation;
* any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results.
A Telerehabilitation Program for SCI

This study evaluates a remotely supervised, home-based therapeutic program to improve upper-limb voluntary movement in adults with tetraplegia caused by incomplete spinal cord injury (iSCI).

Spinal Cord Injury (SCI) has been associated with serious reduction in functional independence. Despite compelling evidence that treatment intensity has a profound effect on motor recovery only a small fraction of SCI population are able to receive intensive in-clinic treatment. Difficulty traveling to the clinic, poor adherence to assignments and high cost are limiting factors. Currently, telerehabilitation programs are emerging as an alternative effective method of delivery for rehabilitation services. The literature and our preliminary findings support the model that augmentation of activity in spared corticospinal tract (CST) axons is a critical mechanism of motor improvement, and furthermore that CST activity can be increased by repetitive motor training and by electrical stimulation of the primary motor cortex (M1). However, there is still lack of knowledge on safety, feasibility and efficacy of remotely- supervised home-based therapy programs that incorporates non-invasive brain stimulation and high intensity repetitive arm exercises. To address these questions, 36 adults (above 18 years) with cervical SCI will be randomly assigned to two groups in a 2:1 ratio (active stimulation group, n=24 vs control group, n=12) and receive daily treatment, 10 sessions, over 2-weeks. The anodal tDCS will be applied over primary motor cortex (M1) at an intensity of 2mA for 20 minutes and proceed with 60 minutes of repetitive arm and hand training. Primary outcome measure is change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) from baseline to immediately after treatment and 4-weeks follow-up. The session will be supervised in real-time via videoconferencing.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of a chronic incomplete cervical lesion as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months post-injury;
2. upper-extremity weakness associated with tetraplegia with minimal residual thumb and index; finger movement sufficient to grip small objects such as marble;
3. no brain injury;
4. no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
5. no contradiction to tDCS;
6. access to internet at home.

Exclusion Criteria:

1. prior history of seizure;
2. chronic use of neuroactive medication (e.g., neurostimulants, anticonvulsants, or antidepressants);
3. any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score ≥ than 3 out of 4.