cyrilzakka/clinical-trials huggingface dataset:
Study of the Immediate and Long-term Outcomes of the Disease in Patients With Left Ventricular Aneurysm Complicated and Uncomplicated by Thrombosis After Transmural Myocardial Infarction, According to the Hospital Registry: SIBYL

A prospective non-interventional study aimed to evaluate the immediate and long-term outcomes in patients with left ventricular aneurysm after transmural myocardial infarction.

A registry of patients with transmural myocardial infarction admitted to the Emergency Department of Cardiology will be created. The registry will include all consecutive hospitalized patients from from January 1, 2021 to December 31, 2021 who meet the inclusion criteria Based on this registry, patients will be divided into groups : patients with left ventricular aneurysm and patients without aneurysm, patients with left ventricular thrombosis and patients without thrombosis.

Patients will be contacted in 3 and 12 months. Surviving patients will be invited to appointment for an ECG, echocardiography and survey. The cardiovascular events during this period will be recorded.

The factors determining the prognosis of patients and their concomitant diseases, immediate and long-term prognoses, therapeutic measures and drug therapy at the hospital and outpatient stages, and patients ' adherence to therapy will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women who had acute transmural myocardial infarction and who were hospitalized to the Emergency Cardiology Department of the N. V. Sklifosovsky Research Institute of Emergency Medicine from January 1, 2021 to December 31, 2021
2. Patients from 18 to 85 years of age
3. Patients who live in Moscow and Moscow region
4. Patients who signed the consent to participate in the study and processing of personal data.

Exclusion Criteria:

1. Patients who refused to come for a second appointment or answer the questionnaire questions
2. Patients who had repeated myocardial infarction
3. Non-compliance with inclusion criteria
The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor

This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable;
2. Eastern Cooperative Oncology Group (ECOG) 0 or 1;
3. Life expectancy ≥ 12 weeks;
4. At least one measurable lesion according to RECIST 1.1;
5. Adequate organ function;

Exclusion Criteria:

1. central nervous system metastasis；
2. There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)；
3. Images in screening showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the investigators believed that it might cause bleeding risk；
4. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures；
5. A history of significant bleeding tendency or severe coagulopathy；
6. The presence of poorly controlled hypertension；
Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot

Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at 35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or pulmonary regurgitation (PR). It is well established that these lesions can lead to irreversible sequelae such as right ventricle dilatation and dysfunction. Pulmonary valve replacement technique was developed to avoid long term right ventricular dysfunction. Pulmonary valve replacement indications are based upon the presence of symptoms at exercise and/or morphological or functional parameters such as severe pulmonary regurgitation with right ventricle dilatation/dysfunction. The best timing of such intervention is still underdebate with the main aim of having the right balance between avoiding long term sequelae of PR or PS and being the latter possible to push ahead the need for new intervention. Recent publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration of myocardial contractility. Quantification of diffuse fibrosis by magnetic resonance imaging is feasible and could help the physician to best determine the right timing for PVR in this population of patients. Cardiac function assessment at rest and during exercise is possible using MR and our centre has developed a program for cardiac exercise during MRI. This could help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise.


Eligibility Criteria:
Inclusion Criteria:

- older than 14 year-old, with repaired tetralogy of Fallot requiring pulmonary valve

Exclusion Criteria:

* liver failure, kidney failure,
* contra indication to MRI study,
* non-affiliated to the national health care program
Myocardial Perfusion Assessment With Multidetector Computed Tomography

Demonstrate the ability of muti-detector computed tomography to adequately perform stress testing will result in a veritable "one-stop shop" of non-invasive cardiac imaging that is, the ability to directly visualize heart arteries with high accuracy and to simultaniously determine the hemodynamic significance of any blockages visualized.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years of age
* Adults undergoing myocardial perfusion SPECT imaging
* Adults with suspected coronary artery disease

Exclusion Criteria:

* Age \<18
* Known or suspected renal insufficiency (Creatinine \<1.7 mg/dl)
* Allergy to contrast
* Inability or contraindication to lexiscan or beta blocker
Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Effects of Exercise Training

Obesity and insulin resistance are worldwide epidemic and taking a major public health toll. Obesity also increases the risk for cognitive impairment which is also an increasing medical, societal, and economic challenge. The ultimate goal of this proposal is to develop a statistical model to assess systemic cross-talk between brain, peripheral tissues, gut microbiota and glucose metabolism. Integrated with exercise training intervention the results will be utilized to provide disease risk profiling and personalized predictions of exercise training as a drug free treatment for insulin resistance and type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* monozygotic twins
* body mass index (BMI) difference ≥ 2 kg/m2 and/or type 2 diabetes
* At least one co-twin is overweight (BMI \> 25 kg/m2)

Exclusion Criteria:

* BMI \> 60 kg/m2
* body weight \> 170 kg
* waist circumference \> 150 cm
* mental disorder or poor compliance
* eating disorder or excessive use of alcohol
* active ulcus disease
* diabetes requiring insulin treatment or fasting glucose \> 10 mmol/l
* pregnancy
* past dose of radiation
* claustrophobia
* presence of ferromagnetic objects that would make MRI contraindicated
Improving Wellbeing of SHP Personnel at UAB

The main objective of this study is to evaluate the impact of a well-being program, SKY Campus Happiness, on well-being of students, faculties, and staff working/studying at School of Health Professional (SHP). SHP is leaning on the SKY Campus Happiness (SKY) program which is an integrative workshop format that includes both skill-building and group dynamics and may be critical for the effectiveness of the program. SKY is a university leadership and well-being program (campushappiness.org) that includes stress-management and tools for psychological resilience: yoga postures, breathing exercises, a breath-based meditation technique \[Sudarshan Kriya Yoga\]. SKY also includes positive psychology skills (e.g., gratitude, social connection, acts of kindness, meaning and purpose). In addition, the curriculum includes discussion and application of leadership skills and service learning. Relying on existing evidence of previous studies, we hypothesize that participating in this program will increase the well-being of people involved.

Students/staff/faculties of SHP will be offered to participate in the SKY Breath Happiness workshop followed by participating in a research program designed to study the potential effectiveness of the SKY Breath Happiness Program as a stress-management, resilience building wellness tool in this population. They will be given an informed consent form to sign if they choose to participate in the study. The course that the students are enrolled in is the SKY program, which is an evidence-based bio-psycho-social program that utilizes a multi-dimensional relationship between biology and behavior. It utilizes a unique set of standardized breathing techniques to rapidly reduce neuro-endocrine stress responses and the autonomic imbalance due to sympathetic overdrive, thus restoring autonomic homeostasis. These are interwoven with coping and stressor appraisal strategies, and simple stretching exercises. Classes will be 3 hours long on each of three consecutive days, and participants must be willing to attend all three sessions. There will also be one mandatory one hour follow-up session one week later. Participants will be asked to engage in daily 10 to 25 minute home resilience practice sessions performed five days per week. To support participants stabilization of the practices, optional daily guided practice will be offered online at a determined convenient time for all participants to allow full participation. The breathing techniques will be taught by certified instructors.

Eligibility Criteria:
Inclusion criteria:

* Healthy students/faculty/staff who at UAB, School of Health Professionals
* Willingness to complete all study interventional components

Exclusion criteria:

* Inability to understand standard English
* Previous participation in a SKY intervention
* Pregnant persons
* Diagnosis of bipolar disorder or schizophrenia
Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children

The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are:

Question 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest

Question 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest

Participants will visit the laboratory on 5 separate days (\> 2-day washout between days) in which they have not previously participated in structured physical activities.

Participants will complete the testing and/or receive treatments below:

Day 1:

* Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
* Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption)

Days 2-5

* Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting)
* Participants' heart rate and self-reported affect and rating of physical exertion will be measured
* Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility
* Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performance

Researcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF.

Further, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.


Eligibility Criteria:
Inclusion Criteria:

* Age between 10-12 years old
* Intelligence Quotient ≥ 85
* Capable of performing exercise based on pre-participation health screening
* No formal diagnosis of cognitive disorders (e.g., attention deficit hyperactivity disorder) and neurological diseases (e.g., epilepsy)

Exclusion Criteria:

* Age outside of the range of 10-12 years old
* Intelligence Quotient \< 85
* No capable of performing exercise based on pre-participation health screening
* Has formal diagnosis of cognitive disorders (e.g., attention deficit hyperactivity disorder) and neurological diseases (e.g., epilepsy)
Educational Interventions on Diabetic Foot Care

Diabetes mellitus currently affects 463 million people worldwide. One of the most serious complications of diabetes is the diabetic foot. Adequate foot care behaviours reduce the risk of ulcers, infections, and amputations, and improve the quality of life, in these patients.

This Pragmatic Randomized Controlled Trial aims to analyse the impact of different educational strategies - an instructive video (Video Watching Group - Experimental Group 1) compared with a leaflet on foot care with real-time guided reading (Real-Time Leaflet Reading Group - Experimental Group 2) and with standard teaching on diabetic foot care (Standard Care - Control Group) - on adherence and knowledge regarding diabetic foot care, as well as on patient's perception of their foot health. Participants will be assessed at the first consultation of the diabetic foot (T0), about two weeks after the first assessment (T1), and three months after the T0 in a follow-up assessment (T2), with T1 and T2 being performed through telephone calls, after obtaining the patients' consent.

The results of the present study will inform educational interventions regarding foot care adherence in patients with diabetic foot, in order to decrease the likelihood of developing diabetic foot ulcers and, consequently, to reduce amputation rates and the several associated costs, contributing to improving patients' quality of life.

Specific Aims

1. To analyze the contribution of sociodemographic, clinical, and psychological variables to diabetic foot care adherence and knowledge, and perceived foot health, over time.
2. To analyze the differences between groups over time in diabetic foot care adherence, knowledge on foot care, and perceived foot health.
3. To examine the mediating role of representations about diabetic foot in the relationship between knowledge about foot care and adherence to diabetic foot care, over time, controlling for health literacy.
4. To examine the moderating role of foot pain, foot function, and footwear between representations about diabetic foot and adherence to diabetic foot care/ perceived foot health, over time.

Data Analysis:

Generalized Mixed Models, which allow examining changes over time including longitudinal mediation and moderation.

Sample size calculation:

Considering a dropout rate of 10%, the sample size required is 60 patients (20 per group).

Procedure:

Participants will be assessed at the first consultation of the diabetic foot (T0), about two weeks after the first assessment (T1), and three months after the T0 in a follow-up assessment (T2), with T1 and T2 being performed through telephone calls.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Diabetes mellitus;
* Diagnosis of Diabetic Foot;
* To benefit from the first assessment and follow-up at the Multidisciplinary Diabetic Foot Consultation of the hospitals where data collection will take place.

Exclusion Criteria:

* Presence of clinical dementia described in the patient's clinical record;
* Cognitive disability to answer the questionnaires;
* Severe visual and/or hearing impairment.
Do Patient Anxiety Levels Decrease Urodynamic Test Reproducibility?

This study will look at how pre-test anxiety levels affect the reproducibility of symptoms during routine urodynamic testing in women. Urodynamics is a test that assesses the function of the lower urinary tract, including the bladder.

The results of urodynamic tests often determine treatment for patients, which may include bladder retraining, medication and/or surgery. Thus, it is important for the results of urodynamics to be accurate and representative of the patient's symptoms outside of the clinic.

Pre-test anxiety levels in women undergoing urodynamics will be measured using a validated questionnaire HADS (Hospital anxiety and depression scale). The patient, prior to their routine urodynamics test, will fill out this self-administered questionnaire.

Reproducibility of patient symptoms will be measured using a non-validated quantitative bladder test assessment. The patient will fill out this self-administered quantitative bladder assessment after their urodynamics test.

The pre-test anxiety and symptom reproducibility variables will be correlated against each other to assess whether there is correlation between the two. A Spearman Rho test will be used to assess the strength of the relationship.

Eligibility Criteria:
Inclusion Criteria:

* Women attending for their first time to the urodynamics clinic for the assessment of their bladder function
* Must be over the age of 18 years old
* Must be able to consent for themselves

Exclusion Criteria:

* Any patients not covered in the inclusion criteria
Proton Beam Therapy to Treat Esophageal Cancer

Assess progression-free survival and overall survival of proton beam therapy (PBT) for patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported outcomes of PBT for esophageal cancer at 6 months following chemoradiation and physician-reported toxicity of PBT for esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
* Staged by PET/CT and esophagogastroduodenoscopy (EGD) OR CT w/contrast and EGD to have stage II or III disease. Endoscopic ultrasound (EUS) is encouraged but not required.
* Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer is eligible, irrespective of margin status.
* Induction chemotherapy prior to concurrent chemoradiation is allowed.
* Prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist.
* At least 18 years of age.
* ECOG performance status ≤ 2 (Karnofsky \> 60%)
* Normal bone marrow and organ function as defined below:

  * WBC \> 2,500/mcL
  * Platelets ≥ 75,000/mcl
  * Total bilirubin ≤ 1.5 x IULN
  * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  * Creatinine ≤1.5 x IULN OR creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document.
* English speaker.
* Financial coverage for proton therapy.

Exclusion Criteria:

* Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone.
* Previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of study entry.
Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease

Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen saturation, but the gold standard for arterial oxygen saturation is co-oximeter which requires an arterial blood sample. The purpose of this research study is to determine the accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen saturation noted in children with cyanotic heart disease. Hence therapeutic interventions (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be delayed and or inadequate. By doing this study the investigators will be able to establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.

Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen saturation, but the gold standard for arterial oxygen saturation is co-oximeter which requires an arterial blood sample. The purpose of this research study is to determine the accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen saturation noted in children with cyanotic heart disease. Hence therapeutic interventions (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be delayed and or inadequate. By doing this study we will be able to establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.

The investigator hopes to learn the limits of accuracy of currently available and used pulse oximeters. In children with cyanotic heart disease the "blue sensor" has been found in small studies to be more accurate compared to the "standard" pulse oximeter.

This study is important as it will provide information as to which pulse oximeter should be routinely used in children with cyanotic heart disease and to assess which SPO2 even with blue sensor is borderline and therefore the physician will know to obtain arterial blood sample for co-oximeter prior to planning important procedures based on a saturation reading.

Eligibility Criteria:
Inclusion Criteria:

1. Children from LPCH undergoing cardiac catheterization or heart surgery in SUMC or LPCH respectively
2. Peripheral arterial saturation less than or equal to 90% at time of enrollment
3. weigh between 3-20 kg
4. Less than or equal to 10 years of age

Exclusion Criteria:

1. Lack of consent
2. Greater than 10 years of age
3. Less than 3 kg or more than 20 kg in weight
4. Peripheral arterial saturation greater than 90% at time of enrollment
5. Lack of arterial access