cyrilzakka/clinical-trials huggingface dataset:
The Effect of Pressure Ulcer Education on the Knowledge Level of the Relatives of the Patients

The purpose of this randomized controlled trial, which included pretest and posttest, was to examine the effectiveness of pressure ulcer prevention and care education given to caregivers of patients treated in a palliative care clinic.

The key questions it aims to answer are:

* Does the routine clinical training given in the palliative care clinic have an effect on the knowledge level of patients' relatives about pressure ulcers?
* Does the pressure ulcer education given to the relatives of patients treated in the palliative care clinic have an effect on the level of knowledge about pressure ulcers?

Participants will participate in an educational activity on pressure ulcers. Researchers will compare whether pressure ulcer training given to palliative care patient relatives is effective compared to routine service training with lecture, question-answer and presentation method.

One-to-one interviews will be conducted with the relatives of the patients in the experimental and control groups, and the appropriate time frame for the clinical operation will be determined. Participants will be informed about the study at the time determined jointly with the companions and at the appropriate place for the clinic.

Personal Information Form and Pressure Ulcer Information Test will be distributed and collected as a pre-test to the participants in the control group. The participants in the control group will not receive any educational intervention by the researcher until the day of discharge. This group will receive routine clinical training given only in the hospital. Training of patients and their relatives in clinics continues with the principle of "Do-Watch-Check". This is how nurses conduct their routine clinical training. The Pressure Ulcer Information Test will be distributed and collected as a post-test to the control group on the day of the patients' discharge.

Personal Information Form and Pressure Ulcer Information Test will be distributed and collected as a pre-test to the participants in the experimental group. In addition to the training given to the participants in the experimental group with the routine "Do-Watch-Check" principle in the clinic, face-to-face pressure ulcer training will be given by the researchers on the day of discharge. The presentation about the pressure ulcer will be given by the researchers in two periods of 30 min + 30 minutes using lectures, case studies and question-answer techniques. Opinions were received from three field experts regarding the validity of the training content of the pressure ulcer topic (CGI: 1.00). The Pressure Ulcer Knowledge Test will be redistributed and collected as a final test on the day of discharge after completion of training.

Eligibility Criteria:
Inclusion Criteria:

* Those who agree to participate in the study
* Native Turkish,
* 18 years and over
* Able to read and write

Exclusion Criteria:

* Who refused to participate in the study
* Native language is not Turkish
* Illiterate
Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease

This epidemiological, transversal, cohort study aims to determine the potential influence of an active long-term hydroxychloroquine intake over the prevalence of a history of symptoms evocative of a COVID-19 infection in patients with a history of systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome or psoriatic arthritis, during the epidemic period in France. The information is gathered using a standardized questionnaire, by phone call.


Eligibility Criteria:
Inclusion Criteria:

* History of Systemic Lupus Erythematosus, Rheumatoid arthritis, Sjogren's Syndrome or Psoriatic Arthritis.

Exclusion Criteria:

* beginning, or end, of an hydroxychloroquine treatment between Jan 1, 2020 and day of the phone call.
* Bad treatment compliance
Single-USe Duodenoscopes PErformance Characteristics and Technical Outcomes: the SUSPECT Italian Prospective Study

Flexible endoscopes are used globally for the diagnosis and treatment of diseases of the GI tract. Duodenoscopes used for Endoscopic Retrograde Cholangiopancreatography (ERCP), in order to treat different biliary and pancreatic disorders, have been recently linked to infections transmission following the procedures. Given their reusability and their complex design of the tip with a moving metallic component, named the "elevator", these instruments must be reprocessed through high level disinfection (HLD) in order to prevent the spread of nosocomial infections. Even strict adherence to all HLD procedures results in a residual level of potentially infectious microbes. In fact, the United States Food and Drug Administration (FDA) postmarket surveillance communication reported duodenoscope culture results demonstrating contamination rates of up to 3.6% for low and moderate-concern organisms and up to 5.4% for high-concern organisms in reprocessed conventional duodenoscopes. As a consequence, at least 20 outbreaks of duodenoscope-transmitted multidrug resistant organism (MDRO) infections occurred between 2012 and 2015, despite reported compliance with duodenoscope reprocessing guidelines. The increasing concern that currents practices of reprocessing reusable duodenoscopes is insufficient, has led the FDA to released recommendation suggesting to develope a newly designed duodenoscopes. On one hand, a way is to generate duodenoscope with disposable components, such as a one-use end cap, which can be removed and allow access to the components of the elevator and other areas of the duodenoscope for reprocessing. On the other hand, an alternative is to produce a fully disposable single-use duodenoscope. The evident advantage of a single use duodenoscope, over disposable components, is that it completely eliminates the need for reprocessing and more important the risk of transmitting microbial infection from patient to patient.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Schedule for a clinically indicated ERCP or other duodenoscope-based procedure

Exclusion Criteria:

* Potentially vulnerable subjects, including, but not limited to pregnant women
* Subjects for whom endoscopic techniques are contraindicated
* Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
The Effect of Glucose-dependent Insulinotropic Polypeptide on the Alpha Cell Response to Hypoglycaemia in Patients with Type 1 Diabetes

The goal of this clinical trial is to evaluate the effects of the hormone glucose-dependent insulinotropic polypeptide (GIP) and its two isoforms, GIP\[1-30\] and GIP\[1-42\], in patients with type 1 diabetes. The main question it aims to answer is:

• What dose and isoform of GIP can most potently stimulate glucagon secretion during low blood sugar in patients with type 1 diabetes?

Participants will go through 5 experimental days that are identical except for an intravenous infusion of either placebo (saline), high or low dose GIP\[1-42\] or high or low dose GIP\[1-30\]. On all days, blood sugar will be lowered to around 2.5mmol/l for around 20-30min.

After being informed about the study and the potential risks, each participant giving written informed consent will participate in five double-blinded experimental days (Day A-E) in a randomized order. Each experimental day is identical except for an intravenous infusion of either placebo (saline), high (8pmol/kg/min) or low (4pmol/kg/min) dose GIP\[1-42\] or high (8pmol/kg/min) or low (4pmol/kg/min) dose GIP\[1-30\].

Each experimental day will consist of an induction period where the participant's blood sugar is adjusted to around 5-6mmol/l with either insulin or glucose. Then the infusion of either placebo or hormone will be initiated and continued for 135 minutes.

After 30 minutes of hormone infusion, a separate infusion of insulin (1.5mU/kg/min) will be initiated and continued for 60 minutes. Based on frequent bed-side plasma glucose measurements and an adjustable 20% glucose infusion, plasma glucose will be clamped at 2.5 mmol/l until the insulin infusion is terminated. Following this is a 45 minute recovery period, during which a minimum of glucose is infused, to ensure a steady rise from 2.5mmol/l to 3.5mmol/l.

After the study day, patients will receive a meal to prevent subsequent hypoglycemia.

The effects of each infusion will be evaluated with regards to glucagonotropic potency, as well as a series of exploratory outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian men
* Body mass index between 18-27kg/m2
* Type 1 diabetes (T1D) (diagnosed according to the criteria of the World Health Organization) with HbA1c\<69 mmol/mol (\<8.5%)
* T1D duration of 2-30 years
* C-peptide negative (stimulated C-peptide ≤ 100 pmol/l)
* Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months
* Informed consent

Exclusion Criteria:

* Anaemia (haemoglobin below normal range)
* Liver disease (ALAT and/or ASAT \>2 times normal values) or history of hepatobiliary disorder
* Late microvascular complications except mild nonproliferative retinopathy
* Allergy or intolerance to ingredients included in the standardized meals
* Prior myocardial infarction or other cardiac events
* Any physical or psychological condition that the investigator feels would interfere with trial participation
* Treatment with any glucose-lowering drugs beside insulin
Prediction of Neurological Outcome of Children After a Traumatic Brain Injury Based on an Integrated Predictive Model

This study aims to develop a integrated predictive model based on serum biomarkers, HRV, and an innovative computerized classifier output, to predict the patient long term neurological outcome after a moderate or severe TBI in children.

Traumatic brain injury (TBI) is a major cause of morbidity and mortality in children. Most children with moderate and severe TBI have long term sequelae including neurological deficit, cognitive impairment and behavioural disorders. In the acute care setting, neither clinicians nor researchers are able to adequately predict the long term outcome of children with TBI, consequently limiting their ability to tailor medical care, rehabilitation and support services. Improving our understanding of a TBI patient's exact cerebral status and prognosis is a critical step toward optimized and personalized patient management. In this research study, an innovative and integrated model will be developed to improve the prognostication in the early phase of a TBI. This model will combine key clinical variables commonly collected in the acute care setting and combine these with cutting-edge empirical measures: 1) biomarkers; 2) a new physiological monitoring based on heart-rate variability (HRV) to assess the integrity of the autonomic system; and 3) a computerized classification tool developed using the concept of artificial intelligence to continuously categorize the patient's cerebral status.

Eligibility Criteria:
Inclusion Criteria:

Children 1) \<18 years; 2) admitted to the Paediatric Intensive Care Unit at the Centre Hospitalier Universitaire Ste-Justine; 3) moderate (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8), assessed after initial resuscitation; 4) admitted to the Paediatric Intensive Care Unit less than 24 hours after the initial TBI and 5) written parental consent. Patients with either inflicted or accidental TBI will be included as they characterize different but important population, our model should be valuable for both.

Exclusion Criteria:

Children 1) suspected of being brain death at the time of Paediatric Intensive Care Unit entry (GCS 3 and loss of all brain stem reflexes); 2) with a pacemaker (HRV monitoring unreliable); and/or 3) patients or parents who do not speak or read English or French.
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy

Thanks to the intrinsic qualities of the proton beam, proton therapy will reduce adverse effects of irradiation. The Proteus®One is the latest generation of proton therapy equipment, enabling the Centre Antoine Lacassagne to expand its range of treatments by carrying out new proton therapy treatments. It has an innovative compact isocentric rotating head (Gantry) that allows the radiation beam to be directed at different angles around the patient. In some cases, two beams are used to treat tumours, and by convention, both beams are delivered during the same session. However, it is necessary to position the patient before each beam, which is time-consuming because 2 beams have to be positioned very precisely each day. The aim of this study is therefore to assess the toxicity of proton therapy delivered by a single daily beam compared with proton therapy delivered by two daily beams, which is the conventional technique.


Eligibility Criteria:
Inclusion Criteria:

* Chordoma, chondrosarcoma of the skull base and spine, Ewing's sarcoma, and osteosarcoma meeting the criteria for treatment by proton therapy
* Tumour requiring 2 beams
* MRI less than one month old
* PS 0-2.
* Patient who has read the patient information note and signed the consent form.
* Patient with healthcare insurance cover.
* Age over 18 years.
* For women of childbearing age, negative urine pregnancy test and effective contraception in place for the duration of treatment and for six months following the end of treatment.

Exclusion Criteria:

* Persons deprived of their liberty or under guardianship.
* Unable to undergo the medical follow-up of the clinical investigation for geographical, social or psychological reasons.
* Patient eligible for symptom reduction surgery Vulnerable populations and participants defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
A Web-Based Healthy Living Training for Promotores

The goal of this clinical trial is to test a new web-based promotora de salud/ community health worker (CHW) training. This training is designed to provide CHWs with the knowledge and skills to effectively implement a healthy living intervention for Latinas. The main question it aims to answer is:

o Do CHWs who complete the web-based healthy living training have higher self-efficacy in implementing core lifestyle intervention learning components for obesity interventions in Hispanics than CHWs who do not?

Participants will:

* Complete a baseline survey asking about self-efficacy related to implementing core lifestyle intervention learning components, knowledge, health behaviors, and skill mastery.
* Be randomized to receive the new web-based training or to a standard CHW training designed by Health and Human Services. The new web-based training provides promotores with the self-efficacy, knowledge, and skills required to effectively implement an obesity intervention for Hispanic women. Promotores will build their skillset through interactive quizzes, exercises, video role-playing scenarios, and interactive tools.
* Complete follow-up surveys at 3 months and 6 months after the baseline survey. This survey will ask the same questions as the baseline survey and will include additional questions regarding satisfaction with training and behavior application.

Researchers will compare participants who receive the new web-based training to participants who utilize the HHS training. The goal is to see whether the new web-based training increases self-efficacy among CHWs to effectively implement core lifestyle learning components for obesity interventions in Hispanics.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and old
* Comfortable speaking, reading, and writing English OR Spanish
* Female
* Access to a computer that has internet
* Not Pregnant
* Have a community health worker certification through the state of TX OR have worked over 6 moths as a community health worker and meets core competencies for CHWs
* Provides services to Hispanic populations

Exclusion Criteria:

* Less than 18 years of age and old
* Not comfortable speaking, reading, and writing English OR Spanish
* Male
* Does not have access to a computer that has internet
* Pregnant
* Does not have a community health worker certification through the state of TX OR have not worked over 6 moths as a community health worker and does not meet core competencies for CHWs
* Does not provide services to Hispanic populations
Catheter Ablation and Surgical Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis

This is an open label, randomized parallel control clinical trial evaluating the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into the group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion) and group C (surgical ablation). Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 80 years old;
2. Persistent AF with severe atrial fibrosis;
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease;
3. With myocardial infarction or stroke within 6 months of screening;
4. With Significant congenital heart disease;
5. Ejection fraction was \<40% measured by echocardiography;
6. Allergic to contrast media;
7. Contraindication to anticoagulation medications;
8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
9. Left atrial (LA) thrombus;
10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;

12. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.
Pilot Study About Extra Virgin Olive Oil "Coratina" in Mild Cognitive Impairment and Alzheimer's Disease Patients

Alzheimer's Disease is a neurodegenerative disease age related caused by neurofibrillary tangles misfolding and Beta-amyloid protein accumulation. In the last decade several findings showed the role of biophenols present in diary intake such as extra virgin olive oil as potential antagonist of neurodegeneration. Two population studies (The Seven Countries Study and Three-City-Study) and four clinical trials (PREDIMED, PREDIMED - NAVARRA, ACTRIN and ISRCTN) have already suggested that mediterranean diet or other diets supplemented with extra virgin olive oil could improve cerebral performance.

24 MCI or Alzheimer's Disease patients will be recruited and randomised; 12 of them will receive extra virgin olive oil "coratina" (EVOO-C); 12 of them will receive biophenol low dose olive oil (ROO). Each patient will consume a total amount of 10 mg olive oil in a year (12 months). Clinical assessement will be based on:

* neurological examination (T0, T6, T12);
* cardiological examination (T0, T12): a supra-aortic vessels and brachial artery ecocolordoppler will be performed;
* ophthalmological evaluation (T0, T12): a optic coherence tomography will be performed;
* neuropsychological assessment (T0, T12);
* nutritional assessement(T0, T3, T6, T9, T12).

Each subject will perform:

* brain MRI (T0, T12);
* Beta Amyloid Positron Emission Tomography (T0, T12) A lumbar puncture will be ruled as well (T0) and markers of neurodegeneration (Beta-amyloid 1 - 42, total tau protein, fosfo-tau, Brain Derived Neurotrophic Factor (BDNF), Neurofilament (NFL) will be quantified); Renal, hepatic and nutritional status will be assessed 3 times in 12 months (T0, T6, T12).

Eligibility Criteria:
Inclusion Criteria:

* MCI diagnosis in the last month prior the recruitment;
* Clinical Dementia Rating Scale - Global Score (CDR - GS) 0,5 and Mini Mental Examination 24 - 27;

Exclusion Criteria:

* smoke;
* hypertension;
* diabetes;
* positive history of stroke, epilepsy or cardiac disease;
* BMI \> 30;
* depression or other psychiatric disturbances;
* low compliance to medical interventions;
* positive history of olive oil allergy or intolerance;
* positive history of chronic inflammatory intestinal disease or malabsorption;
* positive history of maculopathy or retinopathy;
* MRI leukoaraiosis II-III grade Fazekas or MRI lacunar infarctions
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901

The XEN901 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and pharmacokinetics (PK) of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN901 in healthy subjects. It is estimated there will be approximately 64 subjects in the planned SAD and MAD cohorts.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 32.0 kg/m2
* Must agree to use effective methods of contraception, if applicable
* Able to swallow capsules
* Able to provide written, personally signed and dated Informed Consent Form

Key Exclusion Criteria:

* Any history of seizures
* Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject's ability to participate in the study
* Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale
* Mental incapacity or language barriers precluding adequate understanding, cooperation, and compliance with the study
* No prescription or over-the-counter (OTC) medications (except hormonal contraception), herbal or dietary supplements OTC medications 14 days prior to dosing to study end
* No smoking 60 days prior to dosing to study end
* Any clinically significant abnormalities in vital signs, ECG, physical exam, or laboratory evaluations