cyrilzakka/clinical-trials huggingface dataset:
T-Wave Alternans (TWA) Reproducibility in CAD Patients

Microvolt T-Wave Alternans (MTWA) is a relatively new non-invasive method for identifying patients at increased risk of sudden death from ventricular arrhythmias. MTWA can be measured during a routine exercise test, during pharmacologic stress or during cardiac pacing. Its clinical performance compares favorably with that of other non-invasive risk stratifiers and invasive electophysiologic studies. The purpose of the present study is to define the reproducibility of MTWA testing.

The study will be performed in the Cardiac Rehabilitation Center at Assaf Harofeh Medical Center. Patients with coronary artery disease will be eligible to enroll.

Patient will undergo an exercise test on a stationary bicycle. TWA will be measured at heart rate of 105 and 115 BPM. The test will be repeated one week later in the same fashion. The patient will continue follow-up in the rehabilitation center as dictated by the rehabilitation program. Patients will be kept on their regular medications and there will be no change of the medications from the first TWA measurement to the second.

Eligibility Criteria:
Inclusion Criteria:

1. Patients enrolled in the cardiac rehabilitation center program
2. Patients with CAD
3. Age \>18 and \< 80 YO
4. Patients with a pacemaker or defibrillator with normal AV conduction

Exclusion Criteria:

1. Patients with chronic AF
2. Patients with multiple APB's or PVC's
3. Patients who are unable to increase their heart rate to 115 BPM and don't have a pacemaker.
4. Patients who are unable to exercise on a bicycle.
Cerebral Blood Flow During CPB During Cardiac Surgery and the Presence of Post op Delirium

Cardiac surgery is associated with multiple events and issues that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. The risk for postoperative delirium is generally thought to result from some previous health factors added to the susceptibility of the cardiac surgery process.

Cardiac surgery is associated with multiple perturbations that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. These same perturbations likely also increase the risk for postoperative delirium although there are little data that have evaluated this hypothesis.

As the subject is prepared for surgery 2 contact probes will be placed on the forehead to monitor the rSO2 and cerebral blood flow. This monitor can also measureblood flow velocity in blood vessels in the forehead.

This will only be done while the subject is on the cardiac bypass machine during the surgery and end shortly after entering the intensive care unit.Prior to surgery and then once a day on three of the first four postoperative days, patients will be assessed for the presence and severity of delirium with brief standard psychological exams. We will compare rSO2 and CBF changes between patients with and without delirium

Eligibility Criteria:
Inclusion Criteria:

* Patients in the study will be 50 or older undergoing elective cardiovascular surgery using cardiopulmonary bypass.
* Patients who can speak, read and understand the English language.
* Patients who understand the nature of the study and are willing to sign the consent form

Exclusion Criteria:

* Emergency surgery or patients intubated before surgery and, thus, cannot give informed consent.
* Patients diagnosed with neurocognitive disorders (e.g. Alzheimer's, Dementia)
* MMSE score greater than 21 Patients taking antipsychotic drugs A history of drug abuse
* Patients with an implant in the brain underneath the CerOx probes
* Women who are pregnant.
* History of significant, prohibitive skin allergies or reactions-
Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery

The randomized comparison of two strategies in coronary revascularization: bypass surgery without the use of a heart lung machine and coronary stenting procedure.

The comparison comprised the occurrence of cardiac adverse events after the procedure. In addition, costs, cognitive outcomes and angiography were assessed.

Coronary artery bypass surgery with use of the heart lung machine (on-pump surgery), is associated with the risk of peri-operative complications such as death, stroke, myocardial infarction, neurocognitive decline, and extended hospitalization. Bypass surgery on the beating heart without the use of the heart lung machine (off-pump surgery) has been reintroduced in clinical practice in order to reduce these complications. The Octopus cardiac wall stabilizer, developed at the UMC Utrecht, facilitates the safe construction of the grafts during the off-pump procedure. The expected advantages of off-pump surgery e.g. less-invasiveness, complete arterial revascularization, faster recovery and lower costs were the basis for the Octostent trial. We hypothesized that the off-pump surgical technique might offer an alternative for angioplasty with bare-metal stent-implantation.

The current study was designed as a randomized controlled multicenter trial comparing two strategies.

Eligibility Criteria:
Inclusion Criteria:

* patients with coronary artery disease referred for PCI in which both Off Pump Coronary Bypass surgery and PCI were deemed technically feasible

Exclusion Criteria:

* a history of CABG or stenting
* emergency or concomitant major surgery
* Q-wave myocardial infarction in the last six weeks
* inability to give informed consent
An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using Beside Gastric Ultrasound

The aim of this study is to compare the residual gastric volumes in non-labouring parturients prior to elective Caesarean delivery when fully fasted as per European Society of Anaesthesia pre-operative fasting guidelines against the 'Sip Til Send' fasting guideline via a paired cohort study. The primary hypothesis is that 'Sip Til Send' would be non-inferior to standard fasting at minimising the residual gastric volume prior to surgery.


Eligibility Criteria:
Inclusion Criteria:

* planned caesarean delivery under regional anaesthesia
* adhered to national fasting guidance of 6 hrs for food and 2 hours for clear fluids

Exclusion Criteria:

* age less than 18
* inability to understand English
Pregabalin Epilepsy Add-On Trial

To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs
* Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures

Exclusion Criteria:

* Have a treatable cause of seizures
* Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)
Effects of an Interactive ICT-Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer

The purpose of this study is to evaluate the effects of an interactive ICT-platform for use in a smartphone or tablet in patients treated with radiotherapy for prostate cancer. The hypothesis is that clinical management will be improved and costs reduced and safe and participatory care promoted, when patients report symptoms in an application which provides self-care advice and instant access to professionals.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate cancer without metastases or spread to the lymph nodes,
* will receive radiation therapy for at least five (5) weeks,
* literacy in the Swedish language

Exclusion Criteria:

* Patients who need an interpreter at the doctor's visit
* Patients who have a known severe cognitive impairment
Cardiovascular Effects of Prenatal Methamphetamine Exposure

Methamphetamine (MA) is one of the commonly used drugs during pregnancy. Cardiovascular effects of MA include elevated blood pressure, acute vasospasm, atherosclerotic disease, structural and electrical remodeling of cardiac tissue leading to arrhythmias and heart failure, and pulmonary hypertension.1 In addition, MA can cause neurotoxicity with harmful effects on neurodevelopment in the children who had prenatal exposure.5-8 Currently neonatal providers do not perform detailed cardiovascular evaluation in newborn period or long term neurodevelopmental assessments as outpatient for the newly born infants with prenatal exposure to MA, and they do not qualify for early intervention. The goal of the investigators is to perform detailed cardiovascular evaluation in neonatal period and estimate baseline prevalences and follow up with developmental and cardiovascular assessment using a questionnaire at 12 months in a cohort of neonates enriched with those who had prenatal exposure to MA.


Eligibility Criteria:
Inclusion Criteria:

1. Infants born at UCDCH and at AHRO at gestational age \>34 weeks. (\<34 weeks excluded to avoid the effects of prematurity)
2. For the MA exposed subgroup (n=30): Infants born to mothers with prenatal history of MA use during current pregnancy and/or positive meconium toxicology positive for MA in infant.
3. For the MA unexposed subgroup (n=12): Infants born to mothers without prenatal history of MA use during this pregnancy and negative meconium toxicology for MA in infant.

Exclusion Criteria:

a) Presence of congenital anomalies and known fatal conditions.
Diffusion Imaging in Acute Auto-immune Encephalitis

The aim of this non randomised retrospective study is to investigate the imaging (MRI) of auto-immune encephalitis at presentation, especially in diffusion-weighted sequences.

Indeed, few series describe the MRI aspect of auto-immune at their beginning. Recognize early MRI abnormalities seen in auto-immune encephalitis could help reduce the time to positive diagnosis and improve the therapeutic management.


Eligibility Criteria:
Inclusion Criteria:

* Auto-immune encephalitis proved by biological results (blood and/or CSF sample)

Exclusion Criteria:

* No MRI available
Sentinel Lymph Node Identification in the Axilla of Women With Breast Cancer Using Ultrasound and Iron Injection

This study evaluates a new method of testing the lymph nodes in the armpit of patients with breast cancer for tumor involvement. All participants involved in this study will undergo an injection of a small amount of iron dissolved in liquid followed by an ultrasound of the axilla that will make previously invisible lymph nodes visible, allowing them to be sampled in an outpatient setting.

Lymph nodes are small collections of tissue all over the body that drain bodily fluid. These axillary lymph nodes are important in evaluating breast cancer since, if they are positive, it suggests that the cancer cells have spread outside of the breast. The current standard of care is for most breast cancer patients undergoing surgery to have a sentinel lymph node biopsy which is a procedure to take a sample of the lymph nodes in the armpit (also called the axilla) during their breast surgery. However this intraoperative biopsy comes with certain risks such as arm swelling or lymphedema, arm pain, arm numbness/tingling, and/or psychological distress from waiting for the results or the possibility of further interventions. In order to avoid this and have a result before surgery, this study will explore a nonsurgical method of sampling these lymph nodes. Normally suspicious lymph nodes are hard to find accurately by exam and ultrasound.

A new method has been developed that involves injecting a small amount of iron dissolved in liquid into the breast that gets absorbed by the lymph nodes making them bright on ultrasound and possible to biopsy. This method has been shown to have results as accurate as standard sentinel lymph node biopsy by comparing them in the operating room. This study will now investigate performing these ultrasounds and biopsies in the office as well as compare these results to the results of the standard sentinel lymph node biopsy in the operating room. The results of this study could help future breast cancer patients to avoid invasive sampling and all of the accompanying risk as well as give patients and the care team an idea of the extent of disease sooner in order to guide management.

Eligibility Criteria:
Inclusion Criteria:

* Female patients at least 21 years old
* Patients with invasive ductal carcinoma staged T1 or T2 with estrogen receptor and progesterone receptor positive (ER+/PR+) who are scheduled for sentinel lymph node biopsy
* Patients with Ductal Carcinoma In Situ (DCIS) (high or low grade) who are scheduled for sentinel lymph node biopsy including:
* Patients having a mastectomy
* Patients with palpable DCIS
* Patients undergoing breast conservation with large (\>5cm) area of DCIS
* Patients with signed consent to participate

Exclusion Criteria:

* Preoperative palpable axillary lymphadenopathy
* Preoperative ultrasound demonstrating suspicious adenopathy
* Previous axillary dissection or previous lymph node biopsy
* Patients with Invasive Lobular Carcinoma
* Patients who are pregnant
Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure

Research objective.

- To study the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with non-communicable diseases and adverse outcomes in women with premature ovarian failure.

Research objectives:

* To study the associations between combinations of single-nucleotide polymorphisms and behavioural risk factors with heart rate disorders and adverse outcomes in women with premature ovarian failure
* Examine the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with stable STIs in women with premature ovarian failure.
* Examine the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with thrombomolia in women with premature ovarian failure
* Study the associations between combinations of single nucleotide polymorphisms and behavioural risk factors and adverse cardiovascular outcomes in women with premature ovarian failure.

Methods of research:

* Questionnaire .
* Clinical examination
* Blood levels of sex hormones
* Blood lipid spectrum
* Coagulogram
* Glycemic profile
* EchoCG
* SMAD
* ECG
* Daily ECG monitoring
* Questionnaire EQ-5D
* Single-nucleotide polymorphisms of genes of the reninangyotensin-aldosterone system group (AGT, ACE), endothelial dysfunction (NOS3, EDN1), thrombosis-associated (ITGB3, ITGA2, FGB, GPIBA, SERPINE PAI1), pro-inflammatory (CRP, IL17A, IL2, IL10 1, IL10 2, TNFα, CRP 4, IL6, TLR2, TLR3, TLR4, TLR6, TLR9) polymorphisms.

Subject of study.

Women under 45 with Premature Ovarian Failure (PED). It is planned to include 615 people in the study. The study will have both prospective and retrospective parts. Patients will be divided into 4 groups:

* Women with OED without cardiovascular disease
* Women with OAI who have cardiovascular disease
* Control group No 1 Women with normal ovarian function without cardiovascular disease.
* Control group 2 Women with normal ovarian function without cardiovascular disease.

The groups will be comparable in number. All data obtained will be calculated for each group separately. A comparative analysis will then be made for all four groups.

Traditional risk factors, existing non-communicable diseases and the quality of life of patients will be identified using standard research methods.

The selected polymorphism groups are associated with various pathological processes leading to unfavourable cardiovascular outcomes. Their role has not been assessed in patients with premature ovarian failure.

The power of the study was calculated based on the expected number of adverse outcomes.

The division of patients into groups is related to the need to compare and evaluate unfavourable outcomes and non-communicable diseases in patients in order to create a risk scale.

Eligibility Criteria:
Inclusion Criteria:

* women under 45 years old
* presence of premature ovarian insufficiency in the medical history

Exclusion Criteria:

* male gender
* age over 45 years
Study to Investigate Sleep Apnea Patients at Altitude

The purpose of the study is to investigate the effect of an altitude sojourn on patients with the obstructive sleep apnea syndrome

Previous observations do not allow to draw firm conclusions on the effect of altitude sojourn on sleep, breathing and daytime performance in patients with the obstructive sleep apnea syndrome. Furthermore, the susceptibility of sleep apnea patients to high altitude related illness is not known. Therefore, the purpose is to study untreated patients with obstructive sleep apnea syndrome living at low altitude during a sojourn of a few days at moderate altitude in order to evaluate the physiologic effects of hypobaric hypoxia in these patients. We hypothesize that: 1. Sleep and nocturnal breathing disturbances in untreated OSA patients are more pronounced at moderate altitude compared to low altitude. 2. The increase in sleep related breathing disturbances at moderate altitude is due to an increase in central apnea/hypopnea

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea syndrome based on symptoms and a sleep study

Exclusion Criteria:

* Sleep disorders other than obstructive sleep apnea syndrome
* Other than mild, stable cardiovascular disease
* Other than mild lung disease
* Chronic rhinitis, previous uvulopalatopharyngoplasty
* Treatment with drugs that affect respiratory center drive
* Internal, neurologic or psychiatric disease that interferes with sleep quality
* Previous intolerance to moderate or low altitude \< 2600m
Clinical Evaluation on Advanced Resynchronization

The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.

PEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak Endocardial Acceleration sensor features onboard the device.

The study is a prospective, multicentre, controlled and randomised clinical investigation, with two single-blinded arms.

The objective of the study is to compare the clinical benefits of Cardiac Resynchronisation Therapy (CRT) optimised by automatic PEA sensor features (PEA-CRT), with those obtained by standard optimisation procedure (STD-CRT).

The patient candidate for inclusion in the study has a severe chronic Heart Failure, indicated for the implantation of a Biventricular pacing system according to updated ESC guidelines (2005).

All patients included in the study will be followed-up for 1 year; patient's follow-ups are scheduled during hospitalisation, at one month, 3 months, 6 months and one year after implantation.

Eligibility Criteria:
Inclusion Criteria:

The patient candidate for inclusion in the study must be indicated for implantation of a Biventricular pacing system, with the following clinical conditions:

* Severe Heart Failure (NYHA Class III or IV)
* Cardiomyopathy of any etiology
* Sinus rhythm
* Reduced Left-Ventricular Ejection Fraction
* Left-Ventricular End Diastolic Diameter greater than or equal to 30 mm/m2 (LVEDD\>30 mm/m2)
* QRS Duration:

  * \> 150 ms or
  * \> 120 ms and documented Mechanical Dissynchrony (by ECHO) meeting two out of three of the following criteria:

    * Aortic Pre-Ejection Delay \> 140 ms
    * Interventricular Mechanical Delay \> 40 ms
    * Delayed activation of postero-lateral Left Ventricular wall (after mitral valve opening)
* Optimal and stable (1 month before inclusion) pharmacological treatment, including, if tolerated, Beta Blockers, Angiotensin-Converting Enzyme (ACE) Inhibitors or ACE Inhibitor substitutes, Spironolactone, and diuretics

Exclusion Criteria:

Any patient who has one of the following characteristics will be excluded from the study:

* ICD indication (Life-threatening ventricular arrhythmias)
* Persistent or permanent Atrial Arrhythmia without possibility to restore sinus rhythm (spontaneous termination, anti-tachycardia pacing, pharmacological or electrical cardioversion).
* Patient already implanted with a conventional pacemaker device
* Myocardial infarction within the last three months
* Heart surgery, or revascularization within the last three months, or expected
* Heart surgery refused because of co-morbidity factors
* Included in transplantation list
* Already enrolled in other study
* Life expectancy less than 1 year
* Pregnancy
* Age less than 18
* Forfeiture of freedom or under guardianship
* Not able to understand the aim of the study and its procedures
* Refusing to cooperate
Targeted Intervention for Patient Centered Outcome in Patients With Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF), a chronic fibrotic lung disease of unknown cause, is characterized by relentless progression, with a three-year mortality of up to 50%. IPF has high morbidity, with 90% of patients reporting dyspnea at the time of diagnosis and this is strongly correlated with quality of life and mortality. As IPF progress, breathlessness worsens, physical functional capacity declines, and health-related quality of life deteriorates. Pulmonary rehabilitation (PR) can improve well-being in patients with other chronic lung disease, but little is known regarding PR in IPF.

The hypothesis is that the provision of a comprehensive pulmonary rehabilitation program to patients with IPF will significantly improve participant health related quality of life. The objective is to develop a comprehensive, multi-disciplinary 12-week PR program with disease specific educational components for IPF patients. The specific aims of the proposal is to evaluate the effect of the comprehensive PR program on 1) improvements in quality of life using the Medical Outcomes Study 36-Item Short Form 36 (SF-36), a quality of life instrument and 2) improvements in patient self-reported dyspnea scores using the chronic respiratory questionnaire. The investigator intends to evaluate sustained benefits of the PR intervention, changes in depression, anxiety, stress and functional physical capacity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IPF confirmed by lung biopsy or by characteristic pattern on high resolution computed tomogram (HRCT)
* No identifiable cause of lung fibrosis
* PR not received in the past year
* Ability to walk

Exclusion Criteria:

* History of unstable angina
* Deterioration cardiac or neurological disease
* Pregnancy or lactation
* Degenerative arthritis or other limitation to mobility
* PR in the past 12 months