cyrilzakka/clinical-trials huggingface dataset:
Gastrointestinal Tolerance Study of a New Infant Formula

This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, well-nourished, term, Asian infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks)
* The mother had unequivocally decided not to exclusively breast-feed
* Formula fed for at least one week, receiving at least two formula feedings per day
* Birth weight appropriate for gestational age (AGA), 2500-4000g
* Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years.

Exclusion Criteria:

* Age \> 17 weeks
* Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (impacting tolerance and/or growth), such as gastrointestinal malformations, chronic diarrhoea, malabsorptive syndrome, malnutrition, congenital immunodeficiency, or major surgery, as per investigator's clinical judgement
* Infants who suffered from gastroenteritis or diarrhoea in the last 4 weeks preceding study start.
* Infants who used any medication or nutritional supplements (except for vitamin supplementation to complement breastfeeding) in the 4 weeks preceding study start.
* Infants who have medical conditions for which a special diet other than standard (non hydrolysed) cow's milk-based infant formula is required (such as cow's milk allergy, soy protein allergy, fish protein allergy, egg protein allergy, lactose intolerance, galactosemia).
* Infants with any history of or current participation in any other study involving investigational or marketed products.
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Synthetic Generation of Hematological Data Over Federated Computing Frameworks: SCD Use Case

Haematological diseases (HDs) are a large group of disorders resulting from quantitative or qualitative abnormalities of blood cells, lymphoid organs and coagulation factors. Despite most of them (\~74%) are rare, the overall number of HD affected patients worldwide is important, placing a considerable economic burden on healthcare systems and societies. Despite the existence of several collaborative research groups at national and EU level, current clinical approaches are often ineffective, particularly for rarest conditions, due to the relatively low number of patients per disease and the high number of unconnected clinical entities.

SYNTHEMA aims to establish a cross-border data hub where to develop and validate innovative AI-based techniques for clinical data anonymisation and synthetic data generation (SDG), to tackle the scarcity and fragmentation of data and widen the basis for GDPR-compliant research in rare hematological disorders (RHD). The project will focus on one representative RHD use case: sickle-cell disease (SCD).

SYNTHEMA will develop a federated learning (FL) infrastructure, equipped with secure multiparty computation (SMPC) and differential privacy (DF) protocols, connecting clinical centres bringing standardised, interoperable multimodal datasets and computing centres from academia and SME. This framework will be utilised to train the developed algorithms and perform SMPC-based global model aggregation in a privacy-preserving fashion. The resulting data will be validated for their clinical value, statistical utility and residual privacy risks. The project will develop legal and ethical frameworks to guarantee privacy by-design in the collection and processing of health-related personal data and attain an ethics-wise algorithm co-creation. Project outcomes, including pipelines, standards and data, will be made openly available to stakeholders in the healthcare, academia and industry field, and contribute to existing rare disease registries

Eligibility Criteria:
Inclusion Criteria:

* SCD patients (any genotype).
* older than 1 year old

Exclusion Criteria:

* younger than 1 year old
* post HSCT patients
Effect of Cardiac Rehabilitation on Health Status, Emotional Outcomes, and 90-day Readmission Rate Among Cardiac Surgery Patients

this study aims to investigate the effect of the cardiac rehabilitation program on perceived health, status, anxiety, depression, and 90-day readmission rates for post-cardiac surgery patients. The participants in this study will be randomly allocated to either an experimental or control group, the experimental group will receive the cardiac rehabilitation programThe cardiac rehabilitation program extends over 3 months after cardiac surgery. The program includes exercise, health education, and stress management. All content will delivered to the participants through the WhatsApp application as instruction videos and short lectures. exercise will be gradually increased in terms of intensity, and duration. Health education will cover topics like a healthy diet blood pressure, blood cholesterol control, smoking cessation..etc. Stress management will include relaxation therapy, breathing control, behavioral change, and other strategies to control stress. All interventions are guided by universal guidelines like the Australian Cardiovascular Health and Rehabilitation Association (ACRA) and American Heart Association (AHA)..All potential participants will be assessed before being involved in the study. assessment including a general physical examination, inspection of the surgical site, and recent history for potential patient symptoms after discharge, such as chest pain, palpitation, fatigue, or dyspnea. The assessment includes electrocardiograph (ECG), blood samples, and echocardiography analyses. Based on the findings of this assessment, patients will be classified by the cardiologist as either grade I, II, III, or IV, according to the New York Heart Association (NYHA) Classification. Patients who will be eligible to participate in the present study should be grade I or II in the NYHA Classification for dyspnea. Participants in the control group will receive the usual care (general instructions and advice from physicians and nurses). All materials will be delivered to all participants after completing the study.


Eligibility Criteria:
Inclusion Criteria:

1. . aged over 18 years.
2. underwent cardiac surgery.
3. classified as grade I or II according to NYHA classification of dyspnea by the physician.
4. does not complain of any physical or mental condition preventing him or her from participating.
5. agree to participate in the study.

Exclusion Criteria:

1. aged under 18 years.
2. classified as grade III or IV according to NYHA classification of dyspnea by the physician.
3. complain of any physical or mental condition preventing him or her from participating.
Management Of Stoma In Patients Younger Than 3 Months Old

Indications for jejunostomy, ileostomy or colostomy vary in the neonatal population. The most common etiologies are congenital anomalies, such as anorectal malformations, intestinal atresia or Hirschsprung's disease, but also acquired conditions, such as enterocolitis or intestinal perforation. The aim of these stomas is to divert stool in the event of intestinal obstruction or risk of fecal contamination.

Depending on the indication and the type of stoma used, the post-operative follow-up, such as resumption of intestinal transit and feeding, secondary closure of the stoma or not, and the duration and cost of hospitalization differ.

The aim of this study is to compare these differences in order to extract an optimal management strategy, in the light of what is reported in the international scientific literature.

The investigators gathered the data of patients born between January 2009 and December 2023, who had an ostomy made during the first three months of their life.

The investigators then analyzed the patients outcomes ( postoperative complications, length of stay, cost of hospitalization) depending on the etiology of their primary disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had a stoma during the first 3 months of life, from January 2009 to December 2023

Exclusion Criteria:

* Patients who had a stoma after the first 3 months of life, from January 2009 to December 2023
* Patients without a stoma
Accelerated Ambulation After Vascular Access Closure Device

The researchers are seeking to study whether or not there is benefit in keeping patients flat after Angioseal for extended periods of time after diagnostic heart catheterization or if a more aggressive approach of early ambulation would be just as safe while improving cost and patient comfort.

Diagnostic left heart catheterization is the gold standard to assess coronary anatomy. A number of post procedure closure devices have been used in order to be able to ambulate patients after the procedure. Without closure device of the arterial sheath the typical time a patient must lay flat following a diagnostic left heart catheterization at Providence hospital is approximately six hours. This extended time of having to lie flat for the patient is both uncomfortable and time consuming for hospital employees.

The Angioseal closure device is a vascular plug that has been approved by the FDA in order to seal the femoral artery arteriotomy and allow for a faster ambulation time after cardiac catheterization. Currently, the Angioseal device has been approved for ambulation times of 20 minutes after diagnostic left heart catheterization but a more conservative approach is typically used after device. A very common strategy after Angioseal is to keep the patient flat for 2 hours prior to ambulation and then to keep the patient another hour after ambulation for observation of the femoral site.

While a conservative strategy may be considered safer to the operator the Angioseal device has already been approved for an early ambulation strategy. The goal of this study is to reaffirm the safety and efficacy of using Angioseal for early ambulation. If early ambulation is performed it could improve patient comfort and even reduce cost.

Eligibility Criteria:
Inclusion Criteria: Patients undergoing diagnostic left heart catheterization.

Exclusion Criteria: Patients who do not meet criteria for Angioseal closure after diagnostic left heart catheterization.
The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD
* Current or ex-smokers
* FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC \< 70%

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings at screening examinations
* Family history or presence of glaucoma
* Need of long term oxygen therapy
Fear of Activity and Functional Capacity in Patients With Coronary Artery Disease

To identify whether coronary artery disease (CAD) patients have fear of activity, and to assess the relationship between fear of activity and exercise capacity in CAD patients.

Cardiac rehabilitation (CR) is a well-known way of secondary prevention in heart diseases. CR is shown to be effective in reducing cardiovascular morbidity and mortality. CR also enhances exercise capacity and quality of life, promotes healthy and active lifestyle and reduces psychosocial stress and depressive symptoms in coronary artery disease (CAD). Exercise is one of the most important component of CR. The positive prognostic effect of the exercise on cardiovascular disease is mediated by mechanisms such as reducing numerous risk factors, enhancing endothelial function, declining arterial inflammation and stiffness, improving diastolic function, remodeling of left ventricle, and stabilization of electrical activity. Each 1 MET increase in functional capacity is known to improve survival by 12 %. Exercise capacity is a more powerful predictor of mortality among men than other established risk factors for cardiovascular disease.

The prevalence of fear of activity in CAD, heart failure and female patients have been studied by several researchers reporting variable results. It ranges from 70% in acute hospitalized CAD patients to 20% in chronic patients in community. Muscle endurance, steps per day measured by pedometer, IPAQ were found to be lower in patients with high level of fear of activity.They did not measure exercise capacity objectively. Research investigating the effect of fear of activity on exercise capacity in patients with CAD is lacking.

The aim of this study is to identify whether coronary artery disease (CAD) patients have fear of activity, and to assess the relationship between fear of activity and exercise capacity in CAD patients. The hypothesis of this study were that CAD patients would have lower exercise capacity than healthy subjects and CAD patients with higher fear of activity would have lower exercise capacity.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* History of diagnosis of CAD and/or cardiac event in the past 1-60 months
* Being medically stable
* Cognitive and physical ability to complete the required tests.

Exclusion Criteria:

* Patients with recent cardiac event sooner than 1 month
* Musculoskeletal/neurologic problems imparing ambulation or current hospitalization
Data Collection in Patients Undergoing CT-Guided Needle Interventions for NeedleWays System Development

The primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System.

The study will collect anonymized data in support of further development of the NeedleWays System.

The collected data will be:

1. Anonymized CT scans with Patient Reference Frame (PRF) placed upon the scanned area, outside of the sterile field.
2. Screen captures of the NeedleWays Procedure console display as the intervention needle is placed on the patients body, outside of the sterile field.

Eligibility Criteria:
Inclusion Criteria

* Male or female subjects, 18 years of age or older at the time of enrollment.
* Subjects meeting all medical conditions for percutaneous CT-guided needle intervention.
* INR \<1.4
* Written informed consent to participate in the study.
* Ability to comply with the requirements of the study procedures. Exclusion Criteria
* Subjects diagnosed with one or more of the following according to medical records:
* Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting,Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
* Subjects treated with Ticlopidine or similar antithrombotic medication.
* Subjects who cannot tolerate mild sedation
* Subjects with the following laboratory values, unless otherwise approved by hematologist:
* Platelet count \<60,000/ml
* APTT \>39 sec or PT \>15 sec
* Pregnancy or lactation
* Subject is unable to comply with requirements of the procedure, i.e. holding breath.
* Subject participation in an investigational trial within 30 days of enrollment
* Subjects who are uncooperative or cannot follow instructions
Comparison of PEEP in Acute Decompensated Heart Failure

Little is known about optimal level of positive end-expiratory pressure (PEEP) in patiens who recieved invasive mechanical ventilation for acute decompensated heart failure. We therefore sought to compare clinical outcome according to low versus high PEEP.


Eligibility Criteria:
Inclusion Criteria:

1. Subject who was diagnosed with congestive heart failure and objective evidence of pulmonary congestion (pulmonary edema on simple chest radiography or positive B-line on lung ultrasonography AND elevated B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide level) as a reason for invasive mechanical ventilation
2. Age over 19 years old
3. Subject who agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the clinical site.

Exclusion Criteria:

1. Subject who are on mechanical circulatory support (ECMO, intra-aortic balloon pump, VAD) at the time of randomization
2. Subject who has cardiac abnormality that requires emergent or urgent percutaneous or surgical valvular procedure
3. Subject who are on vasoactive or inotropic agents at least moderate dose defined as vasoactive-inotropic score \>10
4. Isolated preload-dependent cardiac dysfunction (isolated right ventricular failure, right ventricular infarction, constrictive pericarditis, cardiac tamponade, severe pulmonary hypertension without LV dysfunction)
5. Predominant right ventricular failure defined as following; clinical evidence of right ventricular failure by attending physician's discretion including hepatojugular reflux, Kussmaul sign, cardiac liver cirrhosis, hepato/splenomegaly, acites, thronmbocytopenia, etc.
6. Subject who are not on mechanical ventilation before open heart surgery
7. Subject who received unwitness cardiopulmonary rescucitation (CPR) or witness CPR lasting more than 30 minutes
8. Subject who was already diagnosed or is suspected to have hypertophic cardiomyopathy with significant left ventricular outflow tract (LVOT) obstruction
9. Subject with intracranial hemorrahge or ischemic stroke at the time of randomization
10. Subject with irreversible neurologic damage or irreversible hepatic failure
11. Invasive mechanical ventilation lasting more than 24 hours preceding endotracheal intubation
12. Subject with underlying chronic obstructive pulmonary disease (GOLD classification III or IV) or restrictive pulmonary disease (e.g. interstitial lung disease)
13. Subject with impaired consciousness that can not perform self coughing and need suction to maintain adequate airway patency
14. Pregnant and/or lactating women
15. Subject with life expectancy less than a year
16. Subject who is not suitable to enrollment by investigator's discretion
Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation-induced Modulation of Hyperphagia in Prader-Willi Syndrome

The purpose of this study is to determine the effects of transcranial direct current stimulation (tDCS) as it modifies hyperphagia in obese subjects, non-obese subjects, and subjects with Prader-Willi syndrome (PWS).

PWS is characterized by hypotonia, feeding difficulties, developmental delay and failure to thrive during infancy, and by an insatiable appetite (hyperphagia), rapid weight gain and obesity in early childhood.

Hyperphagia is one of the most prominent and debilitating features of PWS, and currently no pharmaceutical drug has been successful in decreasing appetite in such patients.

tDCS is a safe, noninvasive method whereby a weak electric current is directly transmitted into the brain via external electrodes connected to a 9-volt radio battery. It is based on decades-old observations that nerve cell firing can be altered by low amplitude direct current (DC). The researchers in this study believe that tDCS may have a positive impact on hyperphagia and weight.

In this study, the investigators intend to assess whether the effects tDCS differ between obese subjects, non-obese subjects, and subjects with Prader-Willi syndrome by measuring the amplitude and latency of eyeblink startle responses to a set of food- and non-food-related visual stimuli in all subjects, various hyperphagia questionnaires, and cognitive and behavioral assessments. It is hypothesized that as a group, subjects with Prader-Willi syndrome will demonstrate behavioral and psychometric evidence of abnormal food image processing, craving and associated behaviors relative to our control groups, and this group may receive potentially beneficial effects from tDCS sessions. Obese subjects are also predicted to have decreased hyperphagia and food cravings as a result of tDCS.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals and individuals diagnosed with Prader-Willi syndrome
* Provide informed consent to participate in the study
* Body Mass Index (BMI) \<25kg/m2 (for non-obese subjects only)
* Body Mass Index (BMI) ≥30kg/m2 (for obese subjects only)

Exclusion Criteria:

* Subject is pregnant at time of enrollment in the study.
* Contraindications to tDCS:

  1. metal in the head
  2. implanted brain medical devices
* Clinically significant and unstable medical disorders (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, pulmonary issues, or chronic obstructive pulmonary disease) as self-reported.
* Clinically significant and unstable psychiatric disorders (e.g., schizophrenia, schizoaffective disorder, other psychosis, bipolar illness, severe depression) as self-reported.
* Significant visual impairment, as self-reported
* History of auditory deficiencies, as self-reported
* History of alcohol or substance abuse within the last 6 months as self-reported
* Use of carbamazepine within the past 6 months as self-reported.
* Current use of antidepressants
* History of neurological disorders as self-reported
* History of neurosurgery as self-reported
The Effect of Thiazide, Amiloride and Hypertonic Saline on Urinary Biomarkers in Healthy Subjects

Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the activity of the sodium- and water channels in the human kidney.

Changes in the sodium-and water channel activity can be induced by blocking the sodium channels with diuretics in healthy subjects

1. Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the kidneys transport of sodium and water in the nephron.
2. Changes in the sodium-and water channel activity is induced by blocking the NCC channels with thiazide and ENaC channels with amiloride and by intervention with hypertonic NaCl The changes in sodium-and water channels are followed by changes in extracellular and intracellular fluids, central bloodpressure and the plasma concentration of vasoactive hormones.

The purpose of this study is to investigate the changes in urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2), extra- and intracellular fluid compartments, central bloodpressure and the plasma concentration of Vasoactive hormones in healthy subjects under a) treatment with Amiloride and Thiazide at baseline and b) after and acute infusion with hypertonic saline.

Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on amount of sodium and calories and randomized to treatment with either thiazide, amiloride or placebo twice daily for 5 days. On the examination days the subjects receive an infusion with hypertonic saline.

Renal function is measured by renal clearance of 51Cr-EDTA. Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) will be measured to evaluate the activity of water- and sodium channels in the nephron, changes in fluid compartments are measured by body composition monitor. Central blood pressure is measured by sphygmocor.

Eligibility Criteria:
Inclusion Criteria:

* healthy males and females
* age 18-45
* BMI range 18,5-30,0 kg/m2

Exclusion Criteria:

* hypertension (i.e. ambulatory BP \> 130 mmHg systolic or/and \> 80 mmHg diastolic)
* history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic
* disease.
* alcohol abuse
* drug abuse
* smoking
* pregnancy or nursing
* blood donation within a month prior to examination
* medical treatment apart from oral contraception abnormal blood samples, -ECG and -urine dipstick, drug abuse, alcohol abuse, pregnancy, medication