cyrilzakka/clinical-trials huggingface dataset:
Validation of a Questionnaire to Evaluate the Home Cooking Skills of Nutrition Professionals and the General Population

The goal of this observational study is to validate the questionnaire HCSQ-ITA in nutrition students and professionals (dieticians, biologists-nutritionists, medical specialists in food science, and experts in gastronomic techniques) or the general population.

The main question it aims to answer is:

- Is the questionnaire to evaluate the cooking skills of nutrition professionals valid? Participants will answer an electronic form questionnaire (HCSQ-ITA) and evaluate its clarity and pertinence.

Unbalanced food choices are a major determinant of the global disease burden, with one in five deaths worldwide attributable to an inadequate diet. Food patterns characterized by reduced consumption of whole grains, fruits, vegetables, dried fruit, and legumes, along with excessive sodium, red or processed meats, and sugary foods, are associated with a high risk of developing chronic non-communicable diseases (NCDs), such as cancer, cardiovascular diseases, and diabetes. High adherence to healthy dietary patterns, such as the Mediterranean Diet, is associated with a lower risk of diabetes, cardiovascular disease, cancer, and cognitive decline. However, global populations are gradually reducing their adherence to this dietary pattern, preferring diets rich in saturated fats and animal-derived protein. This phenomenon, known as the nutritional transition, is associated with a concomitant culinary transition, a progressive change in cooking skills required for home-made meals. Improving culinary skills can have a positive impact on food choices and the quality of the diet. Nutrition professionals can play a crucial role in promoting food and nutrition education initiatives and actions, providing practical experiences and suggestions to help change eating habits. The study aims to validate the Primary Health Care Home Cooking Skills Scale, already validated in Brazil; tool for a representative sample of the general population and nutrition professionals in Italy.

The process of validation will include several stages: (1) the validated Brazilian questionnaire will be translated and adapted to the content. After this, the (2) validation of the content will follow Delphi's technique, and then (2) analysis of the validity and (3) reliability of the construction, through the factor analysis.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years and ≤ 65 years,
* all genres
* signature of informed consent
* nutrition students and professionals (dieticians, biologists-nutritionists, medical specialists in food science and experts in gastronomic techniques)
* general population (non-nutrition professionals)

Exclusion Criteria:

* Serious physical and psychiatric illnesses
* Disorders requiring treatment with atypical antipsychotics
Physiological Effects of ANGPTL3 Variants in Humans

To evaluate the role of ANGPTL3, on lipid metabolism. To explore the role of this protein on glucose metabolism.

Oral fast tolerance test, lipoprotein kinetics and a glucose tolerance test to evaluate the role of ANGPTL3, on lipid metabolism and to explore the role of this protein on glucose metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 or older meeting at least one of the following criteria

  1. Carrying genetic variants in the gene encoding for ANGPTL3,
  2. Unaffected controls matched for age, race, gender,
  3. Willing to follow study procedures
  4. Able to provide inform consent

     Exclusion Criteria:
* Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound the study data
* Taking any medication that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound the study data
* Women that are pregnant or nursing
* History of liver disease or abnormal liver function tests (\>2x upper limit of normal)
* History of kidney disease or chronic renal insufficiency (eGFR \<60 mL/min/1.73 m2)
* Uncontrolled hypertension (\>160/100 mmHg)
* Uncontrolled diabetes
* Anemia (hemoglobin \<11.0 mg/dL) History of a non-skin malignancy within the previous 5 years Major surgery within the past 3 months
* History of any organ transplant
* History of alcohol or drug abuse
* Participation in clinical trials assessing the efficacy and safety of drugs affecting lipid metabolism within the past 6 weeks (or longer depending on the known half-life of the drug) that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound the study data
* Inability to comply to study procedures
Global Longitudinal Peak Systolic Strain (GLPSS) Derived From Transesophageal Echocardiography - A Reliable Measure of Systolic Function?

Systolic function is a substantial determinant of overall hemodynamics and organ function.

Therefore assessment of left ventricular systolic function (LVF) has been of central interest in Echocardiography. Ejection fraction (EF) measurement has been the gold standard echo-derived measure to describe LVF. However, EF is a blood pool derived and therefore load dependent measure.

Global longitudinal peak systolic strain average is a new parameter derived from speckle tracking tachnique. As a primarily myocardial deformation parameter it is considered to be an equivalent to EF measurement, but maybe less load dependend. The aim of the study is to investigate the reliability of GLPSS average to quantify LVF in the perioperative setting (in cardiac and non-cardiac cases).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients in the age from 19-90 years
* Cardiac and non-cardiac surgery, where intubation is indicated
* Surgical procedures with a minimum duration of 30 min
* Elective cardiac surgery on patients scheduled for correction of:

  * coronary artery disease with and without previous myocardial infarction
  * dilated cardiomyopathy; HOCM
  * disorders of the atrial or ventricular septum
  * disorders of the aortic root or the aorta
  * left and right heart valvular disease including stenotic and/or regurgitant valvular diseases.

Exclusion Criteria:

* No patient´s consent
* Contraindications for TEE (esophageal-, gastric disorders, haematologic disorders with increased bleeding incidence; ENT-surgery, surgery of the esophageus or stomach)
* Contraindications for positioning (e.g. clinical signs of acute lung edema/acute failing left or right heart, acute coronary syndrome, myocardial infarction in recent history = within 2 weeks prior to operation date)
China Registration Study in Patients With Skin Infections

The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated Bacterial Skin and Skin Structure Infection due to Gram-Positive Pathogens.


Eligibility Criteria:
Inclusion Criteria:

* Provision of inform consent
* A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria
* Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections involving deeper soft tissue or requiring surgical intervention, a pre-existing lesion or underlying condition affect healing

Exclusion Criteria:

* Subjects known to have any bloodstream infection (including bloodstream infection caused by S. aureus). Subjects whose baseline blood cultures are positive for any clinically pathogenic organism ( including S. aureus ) should be discontinued from study
* Minor or superficial skin infections, Infected "decubitus"ulcer, Perirectal abscess, Hidradenitis suppurativa, Myositis, Multiple infected ulcers at distant sites, Infected burn wounds of a large area,
* Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation)
* Conditions requiring emergent surgical intervention at the site of infection (eg, progressive necrotizing infections)
Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

Hypothesis/Study question

In infants born at less than 29 weeks of estimated gestational age, what are the effects of dexamethasone use on cardiac structure/performance and lung water content?

Study objectives

To measure effects before and after dexamethasone administration on cardiac structure/performance will be evaluated by using the M-mode technique (Devereux method (25-27) and lung water content will be specifically determined by the degree of water retention in premature lungs assessed by lung ultrasound at the pre specified time points.

Methodology / Study design

Single center, prospective observational cohort study planning to enroll eligible patients over a period of 12 months

This study investigates the effects of dexamethasone on cardiac structure/performance and lung water content in the extremely preterm population undergoing treatment for significant lung disease. For that, the specific aims are to determine the occurrence, evolution over time and possible hemodynamic impact of left ventricular hypertrophy and occurrence and degree of water retention in premature lungs, after dexamethasone administration. As secondary outcomes, this study also investigates the effects of dexamethasone on the ductus arteriosus, body growth, and autonomic regulation heart rate variability, as well as other important outcomes outlined in this protocol.

This study hypothesize that in some infants dexamethasone will be associated with the occurrence of early and/or prolonged left ventricular hypertrophy, which may be associated with changes in cardiac performance. It also hypothesize that the anti-inflammatory effects of dexamethasone would improve inflammation of immature lungs, leading to a decrease in interstitial fluid.

Eligibility Criteria:
Inclusion Criteria:

* \< 29 weeks of gestational age at birth admitted at the McGill University Children Hospital's neonatal intensive care unit
* To be initiated on dexamethasone therapy for treatment of significant lung disease as per medical team decision.

Exclusion Criteria:

* Congenital heart disease (except: Atrial septum defect (ASD), Ventricular septum defect (VSD)
* Major congenital anomalies/genetic disorder (Trisomy 13, 18, 21)
* Congenital severe lung or airway malformation (Trachea-esophageal fistula, congenital pulmonary airway malformation, congenital diaphragmatic hernia)
* Twin-twin transfusion syndrome
Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis

The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.

The long-term goal of this project is to improve the outcomes of robot-assisted exercise interventions for patients with reconstructed lower limb following high-energy lower extremity traumas using novel machine learning methods to enable individualized ankle foot orthosis (AFO) designs and self-adaptive AFO assistance.

The main hypothesis predicts greater comfort and lower pain levels when using the new AFO as well as improvements in gait mechanics, which will outperform those induced by patients' daily-use AFOs. The main goal is this adaptive assistance will encourage the wearer's active engagement in RAGT thereby promoting patient self-efficacy/satisfaction and leading to improvements in ambulation after a 6-week rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Have a lower limb injury greater than a year ago.
* Be 18-80 years old.
* Be able to stand for 30 minutes.
* Have enough range of motion in my ankle to comfortably wear the AFO.
* Be able to follow directions and commands.
* Be willing and able to give informed consent.
* Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.

Exclusion Criteria:

* Have any joint or muscle tightness that would limit my movement while walking with the AFO.
* Have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity).
* Have any medical issues that affect my unaffected side.
* Have skin issues that would prevent wearing the device.
* Have a pre-existing condition that caused exercise intolerance. (Documented uncontrolled hypertension, coronary artery disease, abnormal heart rate or rhythm, or congestive heart failure).
* Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
* Have nervous system issues that affect my movement (for example Parkinson's disease, multiple sclerosis).
* Have additional orthopedic issues that interfere with my walking or limit my range of motion in my legs.
* Have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the device.
Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)

Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.

Global, multi-center longitudinal observational cohort study. Collection of prospective clinical data to include liver-related clinical outcomes and safety events, hepatobiliary malignancies, relevant key biomarkers, imaging assessments, PSC-related clinical symptoms, patient-reported outcomes, and medication use in adult patients with PSC.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients between 18 and 75 years of age (inclusive) who can comprehend instructions, follow the study procedures and are willing to sign an Informed Consent Form (ICF).
2. Confirmed clinical diagnosis of large duct PSC based on current AASLD Guidelines (Bowlus 2023).

Exclusion Criteria:

1. Clinically significant acute or chronic liver disease of an etiology other than PSC (with or without presence of features of AIH).
2. Small-Duct PSC.
3. Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.
4. Clinically diagnosed acute cholangitis and currently receiving treatment. Patients on chronic suppressive antibiotics will be allowed to enroll.
5. UDCA dose \>28 mg/kg
6. Evidence of current or historical decompensated cirrhosis based on the following clinical events:

   * Ascites \> Grade 2 and requiring treatment
   * Esophageal or gastric variceal bleeding requiring hospitalization
   * Hepatic encephalopathy (as defined by a West Haven score ≥ 2)
   * Spontaneous bacterial peritonitis defined as ascites absolute neutrophil count \>250/mm3 in the absence of an intra-abdominal source of infection
   * AKI-HRS according to AASLD Guidelines (Flamm 2021)
7. Prior liver transplantation
8. MELD-Na Score \>15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.
9. Participants with current clinical or laboratory evidence of any severe, progressive, or uncontrolled disease, related or unrelated to PSC and which, in the opinion of the investigator, has an expected survival of less than 48 weeks.
10. Participants who are impaired, incapacitated, or incapable of completing study- related assessments or giving informed consent.
11. Prisoners or participants who are involuntarily incarcerated.
12. Participants who are currently participating in an interventional clinical study.
13. Absence of data in medical records to assess inclusion and exclusion criteria.
Collection of Additional Biological Samples From Potentially COVID-19 Patients for Monitoring of Biological Parameters Carried Out as Part of the Routine

Patients infected with SARS-CoV-2 can present with a wide range of manifestations clinical conditions, ranging from no symptoms to serious or chronic illness. The current gold standard test for the diagnosis of COVID-19 is based on a molecular test of reverse transcription polymerase chain reaction (RT-PCR), aimed at detecting the RNA of the virus in respiratory samples such as nasopharyngeal swabs or aspirates bronchial, other methods such as antigen tests and serological detection tests IgM and IgG in response to COVID-19 viral infection, can be used for the purposes of screening in the general population.

In this context of variety of existing tests, it is important to monitor the biological parameters related to COVID-19 pathology by tracking the accuracy, specificity and sensitivity of these tests in current clinical practice.

This research is a collection of additional biological samples with minimal impact on the intake usual care of the patients concerned, for the monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus, in terms of sensitivity, specificity, positive and negative predictive values, for the implementation of indicators quality monitoring of these kits.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient coming for a biological analysis as part of the care for prevention, screening or monitoring of the pathogen target
* Patient able to understand the information note and give a free and informed consent, on paper or digital media
* Clinical patients:

  * Control cases (all comers or ambulatory)
  * Known positive for the pathology concerned
  * Patient hospitalized for the pathology concerned
* Pregnant or breastfeeding patient
* Dialysis patient

Exclusion Criteria:

* Patient already included in a research protocol
* Patient having received medication or treatment experimental or investigational during the last four weeks before collection
* Patient subject to a legal protection measure
* Patient affiliated with state medical aid (AME)
* Patient not affiliated to the compulsory Social Security system
* Refusal or inability to provide signed informed consent
* According to the investigator, the patient is not eligible for inclusion in the study
Efficacy and Safety of LongShengZhi Capsule on Functional Recovery After Acute Ischaemic Stroke (LONGAN)

The aim of the study is to determine if LongShengZhi Capsule is effective and safe in patients with ischemic stroke in comparison to placebo. This trial is a prospective, multicenter, randomized, placebo-controlled, double-blinded, parallel-group, superiority trial.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke patients within 7 days of onset
* 18 years of age or older, and gender not limited
* NIHSS score of 4 to 15

Exclusion Criteria:

* Secondary stroke caused by a tumor, traumatic brain injury, hematological disease, or other diseases with a confirmed diagnosis
* Pre-stroke mRS score of more than 1
* Known severe liver or kidney dysfunction
* Known allergies for ingredients in the investigational product
* Known bleeding diathesis or coagulation disorder
* Known medical condition likely to limit survival to less than 3 months
* Pregnant women (clinically evident) or breastfeeding women
* Participation in any investigational study in the previous 3 months
* Known dementia, uncontrolled psychiatric problems
* Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. The judgment is left to the discretion of the investigator
Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.

There is a risk of falls and injuries in bedridden hospitalized patients, increased in agitated or confused patients. In neurosurgery departments, brain damaged patients can present a loss of consciousness of risky behaviors and be in a state of agitation which frequently leads to their endangerment. The repercussions of this endangerment are multiple. For the patients, there may be a feeling of insecurity, with physical or chemical restraint solutions which deprive them of their freedom without a total guarantee of safety. For the caregivers, there is an emotional distress in front of this endangerment, and a professional guilt. Finally, there are economic repercussions due to the costs of complementary examinations and the lengthening of hospitalization.

The objective of the present study is to determine the nature and frequency of occurrence of risk behaviours, through the observation of bedridden and agitated hospitalized patients. These risk behaviours are defined as potentially dangerous and are warning signs for the caregiver. A better understanding of these behaviours could help to better anticipate falls and injuries and to implement preventive measures more quickly.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in the Neurosurgery Department of the Clermont-Ferrand University Hospital
* Suffering from neurological and/or cognitive disorders leading to agitation and/or confusion
* Affiliation to a social security system
* Hospitalization in the department for at least 9 days
* Acceptance by the patient and/or trusted person capable of giving informed consent to participate in the research

Exclusion Criteria:

* Acute or transient agitation phase of somatic origin (bladder globe, pain, ionic disorder...)
* Patient under guardianship, curatorship or safeguard of justice
* Pregnant and breastfeeding women
* Refusal to participate
Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Pathologically or radiologically confirmed biliary malignant
* Inoperability by staging

Exclusion Criteria:

* Cholangiocarcinoma with widespread metastasis
* Coagulopathy (INR \> 2.0 or prothrombin time \> 100 sec or platelet count \< 50,000)
* Prior SEMS placement
* Pregnancy
* Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
* Life expectancy \< 3months