cyrilzakka/clinical-trials huggingface dataset:
The Impact of First Aid Blended Learning Training on Learning Outcomes and Helping Behaviour of Adult Laypeople in Rwanda

The goal of this study is to assess the impact of a first aid training delivered through a blended learning approach on learning outcomes and helping behaviour in adult laypeople in Rwanda.

Participants will be randomly assigned to either:

* a first aid training with blended learning approach;
* a first aid training with conventional face-to-face approach;
* no first aid training.

All participants will be asked before, immediately after, and 6 months after the first aid trainings to complete

* a questionnaire on first aid-related knowledge, self-efficacy, and willingness to help;
* a practical test on first aid-related skills.

The helping behaviour of the participants will be surveyed before and 6 months after the first aid trainings have been completed.

Researchers will compare the effects in learning outcomes and helping behaviour after 6 months between:

* the first aid training with blended learning approach and no first aid training;
* the first aid training with blended learning approach and first aid training with conventional face-to-face approach.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years) laypeople
* Access to a smartphone or tablet, which is able to install and run a mobile application

Exclusion Criteria:

* Having attended a first aid training in the past
* Having an academic or professional background in the (para)medical field
Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments

Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over four to six hours on two separate dates, separated by two to seven days. The third cohort received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within 30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent.
* Male or female subjects \> 18 yrs. old.
* RLS signs and symptoms affirming diagnosis.
* A baseline score \> or = to 15 is required on the International RLS Study Group Rating Scale (IRLSSG).
* At least one leg with an average baseline Periodic Leg Movement (PLM) while asleep \> or = to 15 movements per hour by actigraphy.
* Subjects on dopa-adrenergic therapy or other RLS treatments must be off therapy at least one week before any baseline RLS assessments and actigraphy measurement are obtained.
* Subject has regular sleep hours between 9 p.m. and 9 a.m.
* Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control.

Exclusion Criteria:

* Known intolerance to Venofer.
* RLS which is ascribed to renal disease.
* RLS 2° to other CNS disease or injury.
* Any pain related or sleep related disorders which may confound the outcome measures.
* History of neuroleptic akinesia.
* Concurrent use of oral iron supplement.
* Parenteral iron use within the past 6 months.
* Active infection.
* Currently being treated for asthma.
* Severe peripheral vascular disease with significant skin changes.
* Seizure disorder currently being treated with medication.
* Serum ferritin level \> 300 ng/mL or a TSAT \> or = to 45% at baseline or a history of hemochromatosis.
* Significant cardiovascular or hepatic disease or any other pre-existing medical condition or disease which in the view of the investigator participation in this study would put the subject's disease management at risk or the subject would be unable to comply with the study requirements.
The Effect of Minimal Flow Sevoflurane Anesthesia

Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

Introduction: Low-flow anesthesia techniques have regained popularity in recent years with the development of low solubility volatile agents such as sevoflurane and desflurane, and modern anesthesia devices. Reducing the flow of fresh gas as much as possible will reduce the amount of volatile agent used, thus preventing air pollution, providing lower costs, and also preserving heat and moisture in the respiratory tract by using rebreathing systems. Laparoscopic surgery is superior to open surgical techniques due to its minimally invasive nature, less postoperative pain, less incidence of wound infections, shortening the hospitalization, and allowing patients to return to their normal lives sooner after the operation.

Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

Material and Method: Seventy patients with ASA (American Society of Anesthesiologists) class I-II between the ages of 18-65 undergoing elective laparoscopic cholecystectomy were included in the study. After the patients were randomly selected by computer, they were divided into two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1 and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1. In both groups. Demographic data, duration of anesthesia, operation times, recovery times, hemodynamic parameters and arterial blood gas parameters of all patients were recorded. The patient data collected in both groups were compared statistically.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) class I-II
* The operation time between 60-180 minutes

Exclusion Criteria:

* Severe cardiac disease
* COPD (Chronic Obstructive Pulmonary Disease)
* Severe liver and kidney disease,
* Diabetes mellitus
* Morbid obesity
* Alcohol and/or drug addiction
* Risk or history of malignant hyperthermia
* Pregnancy and lactation
* Emergency cases
* Operation time less than 60 minutes and longer than 180 minutes
Use of Ex Vivo Lung Perfusion (EVLP) in Reconditioning Marginal Donor Lungs for Transplantation

The overall objective of this study is to evaluate the clinical effectiveness of the novel technique of donor EVLP in increasing lung transplant activity by allowing previously unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory molecules (biomarkers) that would benefit a successful pre-conditioning and increase knowledge of the lungs inflammatory response before transplantation.

Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques. These lungs will be brought to the study transplant centre to be perfused in our system by the transplant team. Perfusion of these lungs will be performed using evaluation solution with addition of red blood cells cross matched with the recipient, heparin and antibiotics. Those lungs that after perfusion in our system meet the normal transplantation criteria will be considered for transplantation. Lungs will be excluded for transplantation if the organs don't meet the normal transplantation criteria.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18 years and over).
* Patients already on or added to the active waiting list for first lung transplant.
* Patients providing informed consent for participation in the study at the time of study commencement or time of listing for transplant.
* Patients' re-confirmation informed consent for the study on the day of the lung transplant.

Exclusion Criteria:

* Patients aged less than 18 years.
* Patients not providing informed consent for the study.
* Patients not in possession of patient information sheets for the study prior to the day of lung transplant.
* Patients' not re-confirming consent for the study on the day of lung transplant.
* Patients requiring invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO) support.
Antabuse in Severe Alcoholism: an Open Controlled Study

Newly detoxified alcoholics (N=60) are randomised to either antabuse (disulfiram) treatment or the control group for a total of 6 months.All patients will receive cognitive behavioural treatment in groups. The hypothesis to be tested is that more of the patients who receive antabuse (disulfiram) will be alcohol free during the 6 months treatment period compared to the control group. The trial is open.


Eligibility Criteria:
Inclusion Criteria:

* Alcoholism
* Living in the departments catchment area

Exclusion Criteria:

* Pregnancy
* Schizophrenia
* Bipolar disorder
* Other substance abuse
* Dementia
* Anorexia
Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis

This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain.

The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time data capture, than remotely delivered exercise coaching alone.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported physician diagnosis of knee osteoarthritis
* Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol)
* Indication of persistent symptoms of insomnia, determined by scoring on the Sleep Condition Indicator questionnaire (as indicated in the protocol)
* If receiving medication for pain or sleep disturbances, having had no change in prescription in the previous three months and be willing to make no other changes to medications for pain or sleep during the active study period.
* Adequate literacy level to ensure web-based surveys can be completed independently, as assessed using a brief 3-item literacy level screener

Exclusion Criteria:

* Concurrent diagnosis of a systemic, inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis)
* Active malignancy
* Neurological conditions (e.g., movement disorders)
* Any medical condition which would make graded increase of physical activity unsuitable (determined by a positive answer to the question: "Has a doctor or healthcare professional advised you to avoid physical activity for any reason?").
* Unable to understand English sufficiently to take part in the intervention.
* Unable to provide electronic informed consent.
* Evidence of significant cognitive impairment (i.e., ≥2 errors on a 6-item cognitive screener).
* Presence of severe psychiatric disorder.
* Currently participating in an interventional trial or a pain or sleep management program or having done so in the past six months.
* Visual or hearing impairment that would prevent use of the intervention.
* Serious physical health concerns necessitating surgery or with a prognosis \<6 months
* Irregular sleep-wake schedule, e.g., shift work.
* Self-report of diagnosis of a specific sleep disorder other than insomnia that is not currently adequately treated, e.g., sleep apnea or narcolepsy.
* Currently meeting or exceeding physical activity guidance from the U.S. Department of Health and Human Services (noted in protocol)
Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects

The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females infected with chronic hepatitis C virus (HCV) infection and genotype 1a or 1b
2. Subjects with a viral load (HCV RNA level) of ≥50,000 IU/mL
3. Subjects with a body mass index (BMI) of 18.0-36.0 kg/m2 (inclusive)

Exclusion Criteria:

1. Subjects should not have previously received a direct acting anti-HCV agent
2. Subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks
Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia

The study will evaluate the efficacy, safety and tolerability of two dosing schedules of LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated acute leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have relapsed or primary refractory non-M3 acute myeloid leukemia or relapsed or refractory non-T-cell acute lymphoblastic leukemia or untreated acute myeloid leukemia in elderly patients.
* Performance status of 0, 1 or 2 per WHO classification.
* Adequate renal and liver function.
* Adequate blood creatine kinase value (CK \< 1.5ULN)

Exclusion Criteria:

* Allogeneic stem cell transplantation within the last 4 months and/or active graft versus host disease requiring systemic immunosuppressant therapy, or autologous stem cell transplantation within the last 4 weeks.
* Patient for which immediate allogeneic stem cell transplantation is the treatment of choice.
* Pregnant or nursing (lactating) women.
* Active CNS leukemic involvement
Enhancing the Emergency Department Experience for Older Adults: Study Protocol for the Implementation of a Comfort Menu and Cart

Introduction: The aging of the population is a global phenomenon, with projections indicating a significant increase in the proportion of individuals aged 65 years and older by 2050. This demographic shift requires adapting emergency department (ED) services to meet the specific demands of older patients, who often present with multiple comorbidities and face challenges such as sensory and cognitive difficulties. EDs, traditionally designed for acute illness and injury management, may not be adequately equipped to meet the unique needs of this vulnerable population. This can result in suboptimal patient experiences, prolonged ED stays, increased hospitalizations, and poorer outcomes.

Objective: This study protocol outlines a before-and-after study to evaluate the impact of implementing a comfort menu and cart on the experience and outcomes of older patients treated in the ED.

Methods: The study will be conducted in the ED of Hospital Sírio-Libanês, a tertiary private hospital in São Paulo, Brazil. Patients aged 65 and older admitted to private ED rooms will be eligible for inclusion. Participants will be recruited in two phases: pre-intervention and post-implementation of the comfort menu and cart. Data will be collected through patient and staff interviews, chart reviews, and a 30-day follow-up interview. Patient experience, staff experience, length of hospital stays, hospital costs, ED readmissions, falls, delirium incidence, quality of life, functional status, cognitive performance, and mortality will be assessed.

Expected Results: A positive impact of implementing the comfort menu and cart in the ED is expected on patient-centered outcomes. Improvements in the experience of older patients and medical and multidisciplinary staff are anticipated, and improvements in other exploratory outcomes, such as length of hospital stay, hospital costs, readmissions, falls, delirium incidence, quality of life, functionality, and cognitive performance, will be explored.


Eligibility Criteria:
Inclusion Criteria:

* ED attendance at Hospital Sírio-Libanês (HSL), São Paulo, Brazil.
* Age ≥ 65 years.
* Accommodation in a private ED bed, regardless of the indication for hospitalization.
* Capacity to consent and respond to the interview or the presence of a companion capable of doing so.

Exclusion Criteria:

* Refusal to participate in the study or use the comfort menu and cart.
* Absence of a companion able to consent to study participation and provide necessary information for patients with altered mental status or cognitive impairment.
* Decreased level of consciousness.
* Hemodynamic instability.
* Acute respiratory failure.
* Inability to be contacted by phone for the follow-up interview.
Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)

To assess the diagnostic validity and cost-effectiveness of a home respiratory polygraphy (HRP) performed at home compared with the standard polysomnography (PSG) in children with clinically suspected Obstructive Sleep Apnea (OSA).

AIMS: To assess the diagnostic validity and cost-effectiveness of a home respiratory polygraphy (HRP) performed at home compared with the standard polysomnography (PSG) in children with clinically suspected Obstructive Sleep Apnea (OSA).

METHODOLOGY: DESIGN: Randomized, prospective, multicenter, double blind and crossover trial. The study will include 320 children, both sexes, with clinical suspicion of obstructive sleep apnea (OSA). MEASUREMENTS: To all patients with clinical suspected OSA and referred to the sleep units, the following questionnaires and measurements will be performed: a) clinic history; b) Anthropometric variables: weight, height, body mass index, neck circumference and percentile; c) Chervin questionnaire, quality of life and clinical questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) Quantitative unbiased proteinic urine analysis and g) Cost-effectiveness variables.

ANALYSIS: Data from HRP and from full PSG will be compared as follows: 1) Agreement of results according to the different apnea-hypopnea index by using the ROC curves; 2) The concordance of the diagnosis and treatment decisions when using clinical findings and data from PSG or HRP at home, 3) All data will be analyzed independently by participating hospitals according the Cohen Kappa method, 4) A diagnosis paradigm based on proteinic defined variables and 5) A cost-effectiveness analysis of the different diagnostic and therapeutic procedures will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Children between 2 and 14 years of age of both sexes consecutively assessed for clinical suspicion of OSA, defined as: snoring children with observed respiratory and / or apnea pauses and / or ventilatory effort during observed sleep, and who were asked for a sleep test
* Written informed consent signed.

Exclusion Criteria:

* Place of residence more than 100 km from the hospital
* Psychophysical incapacity to perform the study at home
* Severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies
* Children with chronic insomnia and / or depressive syndrome
* Children with malformative syndromes, Down Syndrome and neuromuscular diseases
* Complete or near complete nasal obstruction that prevents obtaining a quality signal with the HRP
* History of surgery and / or previous Positive continuous pressure (CPAP) for OSA
Time Trend Analysis of PE Diagnosis With SPECT V/Q: a Single Institution Observational Study

Following the implementation of SPECT V/Q imaging for PE diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on SPECT V/Q to rule out PE. However, PE prevalence was high (28%), which may seem a bit high as compared with other recent studies. The hypothesis was that the use of SPECT V/Q may be responsible for an overdiagnosis of PE, especially at the implementation phase of the test. The aim of this study was to perform a time trend analysis of the evolution over the years of PE diagnosis with SPECT V/Q.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016

Exclusion Criteria:

* Patient under legal or judicial protection
* Patient opposed to the use of his medical data for research.
SES, Health Behaviors and CVD Among Vietnam-Era Twins

To further characterize the nature of the association between socioeconomic status (SES), health behaviors and early cardiovascular disease in the Vietnam Era Twin (VET) Registry, a sample of over 4,000 twin pairs.

BACKGROUND:

Cardiovascular disease (CVD) affects approximately 60,800,000 Americans each year, claiming the lives of nearly one million of these people (American Heart Association, 2001). CVD is likely to be complex in etiology, reflecting the combined effect of both genes and environment, as well as gene x gene and gene x environment interaction. Examination of environmental factors thought to affect CVD risk in the context of a genetically informative design can help elucidate the relative contribution of genetic and environmental factors and potentially aid in identifying environmental factors that may interact with genetic vulnerability in predicting CVD. Cardiovascular morbidity and mortality are over-represented among individuals in lower socioeconomic strata, as are behaviors that increase the likelihood of cardiovascular events, including smoking, heavy alcohol consumption and physical inactivity (Adler et al., 1994; Anderson \& Armstead, 1995). Thus, it is commonly assumed that socioeconomic status (SES) serves as an important environmental influence on health and health behaviors. Twin studies partition genetic and environmental variance and detect gene x environment interaction and provide a unique opportunity to study the association between SES and health.

DESIGN NARRATIVE:

The study will characterize the nature of the association between socioeconomic status (SES), health behaviors and cardiovascular disease (CVD) in the existing Vietnam Era Twin (VET) registry, a sample of over 4000 male twin pairs with a mean age of 51 in 1999. Specifically, the study will: 1) determine how strongly environmental factors contribute to individual differences in SES, health behaviors and CVD, relative to genetic factors; 2) examine whether measures of SES are associated with health behaviors and CVD mortality when controlling for concomitant genetic influences; and 3) investigate whether SES interacts with genetic vulnerabilities to predict health behaviors and CVD (gene x environment interaction). Using VETdatasets, the primary method of analysis will be twin structural equation modeling.

Eligibility Criteria:
No eligibility criteria