cyrilzakka/clinical-trials huggingface dataset:
Comparison Between IV Propofol and Propofol/ Fentanyl Anesthesia on Patients Stress Response

It is hypothesized that propofol, when used in general anesthesia (GA) influence patient's stress status and consequently affect stress response parameters. Hence, the objective of the presented research is to assess whether the propofol has anti-stress effect or not in patients undergoing surgeries that require GA and classified as The American Society of Anesthesiologists physical status 1 (ASA PS1)

* Forty patients will be divided into two groups of patients (n=20 each), where in the first group anesthesia induction will be with propofol as a single agent, while patients in the second group will be anesthetized by propofol/fentanyl and the depth of anesthesia will be determined by BIS score and will be kept at 40-60.
* In both groups, blood will be withdrawn to assess the possible effect of these medications on stress by measuring the following parameters:

I- Hemodynamic indicators II- Catecholamines . III- Fasting blood glucose IV- Insulin level V- Cortisol VI- Vasopressin

VII- Cytokines:

Eligibility Criteria:
Inclusion Criteria:

ASA1

Exclusion Criteria:

* Patients who refused to participate in the study or to sign the consent form
* The very young and very old patients
* Severely agitated (panicked).
* ASA1 patients who had bradycardia during propofol induction and was reversed with atropine.
* Patients with any of the following pathologies: liver, kidney, lung, or cardiac diseases, allergic to medicines, alcohol abuse, pregnant, or having endocrine or neuropsychiatric diseases. Moreover, those with sepsis syndrome with hemodynamic instability, hypothermia, and poorly controlled coagulopathy will not be enrolled in this study.
A Study of the Safety of REN001 in Patients With McArdle Disease

The purpose of this study is to assess REN001 safety in subjects with McArdle Disease


Eligibility Criteria:
Inclusion Criteria:

* Subjects must give written, signed and dated informed consent
* Confirmed diagnosis of McArdle Disease
* Subjects must be able to remain on stable medication through the study and specifically must not commence or have changes to agents that affect metabolism such as medication for diabetes
* Follow a stable dietary regimen as documented by a 3-day dietary record obtained during the screening period.

Exclusion Criteria:

* Documented history of ongoing rhabdomyolysis
* Evidence of acute crisis from their underlying disease
* Currently following or planning to start a ketogenic diet
* Treatment with an investigational drug within 1 month or within 5 half-lives, whichever is longer
* Have been hospitalized within the 3 months prior to screening for any major medical condition
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator in discussion with the Medical Monitor, would make the subject inappropriate for entry into this study
* Pregnant or nursing females
The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)

Preliminary data suggest that:

1. a different risk of mortality, as assessed by the Multidimensional Prognostic Indices (MPI), may influence the anticoagulant prescription in older subjects with Atrial Fibrillation (AF);
2. the presence of multidimensional impairment, disability and multi-morbidities are usually not included in the decision algorithm of the more appropriate treatments in older patients with AF;
3. considering the prognostic information, as calculated by the MPI, can be useful to physicians in identifying older patients with AF that can benefit from anticoagulant treatment in term of increased survival.

The main objective of this observational study is to evaluate in a "real world" population of older hospitalized patients with AF, the clinical benefit/risk ratio of the anticoagulant treatments in terms of:

1. mortality (all-cause and vascular mortality);
2. thromboembolic events, i.e. stroke, systemic embolism;
3. bleeding side-effects, especially intracranial and gastrointestinal bleeding Secondary objective of the study is to evaluate whether a different prognostic profile, as determined by the MPI, is associated with 1) different kind of treatments for AF (no treatment vs anticoagulants, i.e. Vitamin K Antagonists (VKA) or novel oral anticoagulant (NOACs); and 2) differences in the main outcomes (i.e. mortality, major thromboembolic events and side effects including bleeding events).

Eligibility Criteria:
Inclusion Criteria:

This is an observational study in which all consecutive patients admitted to the Geriatrics Units involved in the project will be screened for inclusion. The inclusion criteria are:

1. patients of both genders, aged 65 years and older
2. admitted to hospital for acute diseases or a relapse of chronic diseases
3. with a documented diagnosis of non valvular AF
4. who are willing to participate in the survey and give their informed consent

Exclusion Criteria:

1. age less than 65 years
2. patients who have not provided informed consent
Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

The investigators are selecting sixty (60) with breast cancer diagnoses where the surgical treatment is indicated.Furthermore the investigators divided in two groups : 1) surgical treatment using regular electric scalpel ; 2) surgical treatment using argon plasma coagulation scalpel. Our primary goal is to measure the bleeding during the surgery using the weight of the surgical tissues used. Secondary we'll evaluate the immediate post operative outcomes, like infection, hematomas and seromas. All these variables will be evaluated by a doctor using our standard clinical record and it will be measured using reliable parameters, for exemple: if the investigators clinically detect a hematoma then we'll perform an ultrasound to take the real extension; if the investigators clinically pick an infection we'll measure the extension of the hiperemia; and if the investigators clinically pick a seroma we'll drain and quantify it. Secondary the investigators going to evaluate and measure (centimeters) the terminal damage caused on the surgical specimens (samples) using the microscope.


Eligibility Criteria:
Inclusion Criteria:

* operable breast cancer

Exclusion Criteria:

* coagulation disturbs
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers

The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS AGT-LRx in up to 82 Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements
* Healthy males or females aged 18-60 inclusive and weighing ≥ 50 kg at the time of Informed Consent
* Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* BMI ≤ 35 kg/m
* Agree to conduct at home blood pressure monitoring (in triplicate using study provided device) every morning and every evening throughout study participation for Single-Dose Cohort subjects and every morning for Multiple-Dose Cohort subjects

Exclusion Criteria:

* Treatment with another Study Drug, biological agent, or device within one-month of Screening
* Subject with borderline orthostatic hypotension defined as a fall in systolic blood pressure of ≥ 17 mmHg or diastolic blood pressure of ≥ 7 mmHg when they assume a standing position (within 3 minutes of standing up)
* Use of nicotine-containing products or illicit drugs
* Considered unsuitable for inclusion by the Principal Investigator
Alpha-defensin as a Diagnostic Means to Distinguish Between Acute Bacterial and Viral Infections

This study aims to investigate the use of alpha-defensin as a diagnostic means to distinguish between acute bacterial and viral infections.


Eligibility Criteria:
Inclusion Criteria:

* Children with either bacterial or viral infections

Exclusion Criteria:

* All others
Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease

This is a prospective, observational, single-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis in Multi-Vessel Disease.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age.
* Patients with stable angina or unstable angina or NSTEMI, with at least 1 stenoses ≥ 50% in two main vessels (LAD, LCX and/or RCA) each and in whom invasive FFR is being assessed at these stenoses.
* Patients undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
* Written, informed consent.

Exclusion Criteria:

* Contraindication for FFR examination or administration of vasodilators.
* Clinical presentation of an acute infarct (STEMI) or presented with STEMI in past year.
* CTO in a target vessel.
* Prior CABG, valvular surgery, TAVI/TAVR, or heart transplantation.
* Known LVEF ≤45%.
* Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging.
* TIMI Grade 2 or lower at baseline.
* Target lesions involve Left Main (stenosis ≥50%.)
* In-stent restenosis in a target vessel.
* Heavily diffused atherosclerosis diseases defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
* Target coronary vessels are supplied by major collaterals.
* Lesion is in ectatic segment which includes dilatation in diameter at least 1.5 times that of the adjacent normal coronary artery.
* Coronary angiograms not acquired per instructions as defined in the Study Protocol.
Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic

The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics.

The exponential increase in the production and use of plastic goods translates into a parallel increase of environmental plastic waste that is continuously degraded into micro and nanoplastics (MNPLs). Information on their effects on human health is still preliminary, especially regarding human biomonitoring studies, thus more information is required for risk assessment evaluation.

This observational study aims to evaluate the exposure to MNPLs in human populations occupationally exposed to different types of plastics (fibers and plastic waste). The study will evaluate the effect of exposure to MNPLs (genotoxic and microbiota effects) in different body samples (blood, exfoliated buccal cells, urine,and feces) and also will use those samples to evaluate the presence of MNPLs.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years.
* Healthy subjects defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urine analysis.
* Able to participate and willing to give written informed consent and to comply with the study restrictions.
* Have been working at the company for the last 48 months

Exclusion Criteria:

* Workers decline participation
* Legal incapacity or inability to understand or comply with the requirements of the study.
* Any hierarchical subordination to the PI
* Clinically significant findings as determined by medical history taking, physical examination, ECG, and vital signs.
* Submitted to X-ray in the three previous months
Adolescents Bariatric Surgery Cohort Survey

Obesity affects 3%-4% of the pediatric population and leads to cardiac mortality during adult life. Bariatric surgery is the best treatment for weight loss and preventing obesity associated comorbidities in adults, but its applications and safety are yet to be defined for adolescents.

Since 2008, in France, certain university hospitals have been eligible to perform bariatric surgery for adolescents. It was therfore possible to define its feasibility, potential complications and specific indications.

This led to recommandations published by Health Authorities (HAS) in 2016. However, it seems imperative to continue monitoring these patients in order to improve their management, especially as the use of these surgical techniques becomes increasingly widespread.

The Angers University Hospital is one of the leading hospitals when it comes bariatric surgery for adolescents through its use of gastric bands.

The aim of this protocol is to update data on how effective this surgery is on weight loss and obesity-associated comorbidities, and to monitor medical, psychological and surgical complications associated with this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 14-20 years of age and asking for bariatric surgery
* BMI \>= 40 Kg.m-2 or \>= 35 Kg.m-2 with major obesity-related comorbidities (hypertension, diabetes, sleep apnea, etc...)

Exclusion Criteria:

* An unstable psychiatric disorder
* Bariatric surgery anesthesic contraindications
* Having not completed a minimum of six months of the pre operative program
* Lack of consent from the patient or the patient's relatives.
PICO Dressings for Emergency Laparotomy

SSI (Surgical Site Infection) rate is an important consideration after emergency laparotomy. SSIs carry a high financial burden for health institutes with the cost of major SSIs after emergency laparotomy to add an additional cost of £10000-£15000 per patient.

NICE has recommended the use of PICO dressings for the reduction of SSI rate as a cost-neutral.

The purpose of this study was to review the current SSI rate, assess the patient risk factors for development of SSIs and evaluate if the use of PICO dressings as per NICE guidelines will reduce the SSI rate.


Eligibility Criteria:
Inclusion Criteria:

* All emergency midline laparotomy
* Laparoscopic converted open

Exclusion Criteria:

- Reoperation with 28 days of index laparotomy
BLITZ Heart Failure

To evaluate if Italian Cardiologists are treating Heart Failure (HF) patients according to International guidelines and if a structured educational program can improved their adherence.

Multicentre, cross-sectional, prospective, non-interventional, observational study designed to evaluate the level of adherence to current ESC guidelines recommendations in both acute and chronic HF patients enrolled in each participating center and to verify if a specific HF educational intervention composed by an educational web based program of data collection and face to face meetings is able to improve adherence to guidelines recommendations evaluated during a second enrollment period.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with chronic HF and those admitted for acute (de novo) or worsening chronic HF.
* Chronic HF: any NYHA class (I-IV).
* Acute HF Only patients in NYHA class III or IV, or with pulmonary edema or cardiogenic shock for whom an IV therapy specific for HF (diuretic, vasodilators, vasopressors) is administered.
* Any gender.
* Any etiology of HF.
* Any level of EF.
* Written informed consent.

Exclusion Criteria:

* - Age \<18 years.
* Inclusion in registries or trials that can influence, by protocol, the clinical management of patients.
* Patients already enrolled in the BLITZ HF (by another participating centre or in the first enrollment period).
Complications in Inguinal Hernia Surgery

Inguinal hernia repair is the most common procedure in general surgery. Even with acceptable complication rates, thousands of patients worldwide suffer from inguinal hernia surgery complications every year. In Finland, the Finnish Patient Insurance Centre (FPIC) receives reports from surgical complications. In this study, the database of FPIC is used to compare the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.


Eligibility Criteria:
Inclusion Criteria:

* surgery between 2002 and 2010
* complicated inguinal hernia surgery reported to FPIC

Exclusion Criteria:

* none
Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma

On average, each year in the former region, 60 new patients under the age of 18 are treated for a brain tumor, with an active post-treatment follow-up file of 350 patients. Because of the significant sequelae induced by the disease or the treatments, these patients will very often require rehabilitative care.

The interest of involving the horse in the population of patients cured of a medulloblastoma but with important physical and psychological after-effects is to be able to combine a therapy using animal mediation (equitherapy) and a rehabilitation therapy based on the three-dimensional movement of the horse (hippotherapy).


Eligibility Criteria:
Inclusion Criteria:

* complete remission of medulloblastoma and after 5 years of the end of treatment
* living within 30 km away the riding center and/or less than 1 hour of transport
* informed consent

Exclusion Criteria:

* Landsky score below 50% for minors until 16 years old and Karnofsky score below 50% for patients over 16 years
* major under juridical protection
Bedside Lung Ultrasonography by Nurses in Acute Dyspnea.

This study assesses the potential of lung ultrasonography to diagnose heart failure.

Dyspnea is one of the most distressing situations for the patient . Emergency cases do not always present in conditions that are ideal for immediate diagnosis, which sometimes compromises outcome. Physical examination, laboratory findings and radiography are imperfect, resulting in a need for sophisticated test results that delay management.

Lung ultrasonography is becoming a standard tool in critical cases in the ED.

the investigators aim to perform ultrasonography on consecutive patients admitted to the ICU with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the nurses.

Three items were assessed: artifacts (horizontal A lines or vertical B lines indicating interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion, these items were grouped to assess ultrasound profiles.

the study aimed to evaluate the accuracy and reproducibility of B-lines testing assessed by emergency nurses after 12-h training in the diagnosis of HF in patients admitted to the emergency department with acute dyspnea.

Eligibility Criteria:
Inclusion Criteria:

* non traumatic dyspnea with the final diagnosis of heart failure

Exclusion Criteria:

* age less than 18 years
* impossibility to give consent to participate in the study
* post-traumatic dyspnea
* pregnant women
* need for endotracheal intubation or inotropic drugs
* patients who were deemed too unstable for sonography by the treating team
Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD

Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD.

Within the CD diagnosis, a subset of youth (12-46%) display callous-unemotional (CU) traits (termed "limited prosocial emotions"). CU traits denote additional symptoms including a lack of remorse/guilt, a callous lack of empathy, shallow affect, and/or lack of concern about performance. Although both CD and CU traits are inextricably linked to poor outcomes for youth, there remains a scarcity of targeted interventions for CD and CU traits. One of the most significant challenges for treatment is that youth with CD are often perceived by providers as treatment-resistant and treatment disrupters. This leads to poor treatment retention and further isolation from treatment opportunities. Further, existing interventions that target antisocial behaviors more generally are costly because they require 24/7 behavioral management therapies. Impact VR is a psychoeducational intervention for improving emotion recognition and regulation, using immersive gameplay and storylines that are relevant to youth. Impact VR uses evidence-based cognitive and dialectical behavioral approaches to improve emotion regulation. At the center of Impact VR is an individualized training program that teaches youth to effectively identify emotional expressions in others.

Eligibility Criteria:
Inclusion Criteria:

* Aged 10-17 years old
* Identified through the TriNetX database as having a conduct disorder diagnosis
* English speaking

Exclusion Criteria:

* Youth aged \<10 years and \>18 years old
* Non-English speaking
* Youth of caregivers younger than 18 years old.
Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation

Early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. To achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity assessment. The objective of this study is to assess the performance of a new non-invasive ultrasound-based system for the assessment of liver fibrosis and steatosis severity, via ultrasound biomarkers such as tissue stiffness (correlated to fibrosis severity) and ultrasound tissue attenuation (correlated to steatosis extent).

The study will enroll adult patients with known chronic liver disease, and referred to a hepatology outpatient visit for liver fibrosis assessment.

Performances will be assessed from correlation coefficients between biomarkers estimated by the medical device subject of the research and reference measurements obtained non-invasively from other commercially available equipment.

Repeatability and reproducibility of biomarkers estimations by the medical device subject of the research will be assessed from intraclass correlation coefficients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with known chronic liver disease and referred to the outpatient hepatology clinic for a consultation focused on chronic liver disease severity assessment, independently of the study (=in routine patient care).
* Patient who voluntarily consents to participate in the study, after being informed on study objectives and personal rights
* Patient who is registered to the French social security program

Exclusion Criteria:

* Adult patients under guardianship
* Adult patients not being under guardianship, unable to express consent for participation
* Pregnant women
* Breastfeeding women
* Patients under deprivation of liberty
* In-hospital patients not having given their consent to participate, or admitted in emergency
* Patients admitted in social and care centers for other reasons than those of the research
* Patients enrolled in other studies that have the potential to interfere with current research, or during the exclusion period forced by their participation in other research.
Long Time Follow up After HJ Following Iatrogenic Bile Duct Injuries

Introduction: Bile duct injury (BDI) after cholecystectomy remains a serious complication with major implications for patient outcome. For most major BDIs, the recommended method of repair is a hepaticojejunostomy (HJ). We conducted a retrospective review from 5 Danish hepatobiliary centres aiming to examine the perioperative and the long-term outcome after reconstructive HJ.


Eligibility Criteria:
Inclusion Criteria:

* All patients with iatrogenic Bile duct injury (BDI) after cholecystectomy reconstructed with hepatojejunostomy/choledochojejunostomy.

Exclusion Criteria:

* Patients with non-cholecystectomy-related BDI or with cholecystectomy-related BDI that had been definitively managed by other techniques.