cyrilzakka/clinical-trials huggingface dataset:
Interventional Study of Mental Health Literacy Educational Program for General Hospital Nurses

Mental health literacy is a concept that encompasses knowledge of mental health, mental illnesses, and their management; mental illness-related attitudes/ stigma; and help-seeking efficacy. It impacted care provision by affecting healthcare professionals' ability to recognize, manage and prevent mental illnesses. It was found that physical-mental comorbidity (co-occurrence of physical and mental illnesses) imposed a burden on patients and the healthcare system. However, the referral rate to psychiatric consultation-liaison in general hospitals was low could be attributed to the suboptimal level of mental health literacy of general hospital healthcare professionals. Nurses are the major healthcare workforce in general hospitals for the initial identification of mental illness, help doctors to deal with patients' conditions, and make a contribution to positive patient outcomes in general hospitals. Therefore, there is an urgent need to improve the mental health literacy of nurses working in general hospitals.

An education program had been developed guided by the concept of mental health literacy, and self-efficacy theory. This study aims to examine the effect of an educational program on improving the mental health literacy of general hospital nurses, in terms of knowledge of mental health, mental illnesses, and their treatment; attitude or stigma about mental illnesses; and help-seeking efficacy. It also measures the interventional effect on perceived competency in caring for patients with mental illness and work stress among general hospital nurses, as well as patient satisfaction with nursing care in general hospitals.

This study is a prospective 2-arm parallel controlled trial. The study sites will be conducted in the emergency departments and medical wards of two similar regional general hospitals. It is estimated using GPower that a sample size of 64 participants per group is adequate to detect an effect size of 0.5 on the primary outcomes at a post-intervention time point with 80% power at a 5% level of significance. Participants will be assigned to either an intervention group or a control group. Participants in the intervention group will receive a Mental Health Literacy Program consisting of six 30-minutes online educational sessions and one 60-minutes face-to-face session. No active intervention will be given to the control group. Outcome measures will be measured by the Mental Health Literacy Scale, the Behavioral Health Care Competency survey, the Workplace Stress Scale, and Hospital Patient Satisfaction Survey at baseline, immediately after intervention, and one-month after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Full-time registered nurse (general) or enrolled nurse (general)
* Take care for adult patients in emergency departments or medical ward

Exclusion Criteria:

* Does not understand Chinese and English
* Unable to access or use the internet.
Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Heat Stroke

Heat stroke is a clinical syndrome with high incidence and high fatality rate in summer. Patients with liver, kidney, and brain damage are prone to secondary MODS, and the prognosis is poor due to high medical costs. At present, there is no unified diagnostic criteria for acute liver injury associated with heat stroke, and the commonly used prognosis scores are rarely included in liver injury indicators, which is not good for practicality.

The project intends to collect the peripheral blood of the normal population, the 24 hours after the onset of heat stroke and the patients in the recovery period, to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to search for indicators related to disease deterioration and prognosis, construct and verify the early warning and prognosis evaluation system of the disease.

On this basis, the researcher explore cellular and molecular mediated pathological mechanisms of heat stroke, and then clarify the treatment target of heat stroke.

Eligibility Criteria:
Inclusion Criteria:

1. The patient voluntarily signs an informed consent form;
2. Adult patients who meet the criteria for heat stroke;
3. Heat stroke is defined as heat stroke (Heat Stroke, HS) is a serious fatal disease caused by heat injury factors acting on the body, accompanied by multiple organ damage.

Exclusion Criteria:

1. Age \<18 years old or \>90 years old;
2. Patients with advanced tumors, Pregnancy or lactation;
3. Patients who missed out during treatment and whose data are incomplete.
What Benefit of a Full Analysis of Exome? Routine Care Study in Patients With Solid Tumors

The management of cancers and their therapeutic guidance was until shortly mostly based on histopathological considerations of the tumor. the development of targeted therapies is a turning point and keeps increase. These molecules target a specific molecular defect in the tumor making it more effective and more specific treatment. But these treatments are only effective if the tumor has a specific molecular abnormality that is characterized and known.

These therapeutic progresses have been made possible through the decoding of the human genome and the molecular defects occurring during the carcinogenesis process. Now, dozens of therapies targeting a specific molecular abnormality are available in the therapeutic arsenal and dozens more are under development in clinical trials Phase 1 to 3.

In recent years, the democratization of next generation sequencing has opened a new era in cancer research but also for molecular diagnostics. Indeed, the enormous sequencing capabilities offered by high-throughput sequencing technologies allow analysis in a limited time the entire coding sequence of the genome (exome), or even the entire genome of a tumor (whole genome sequencing). Thus, the evolution and the development of broadband and associated bioinformatics tools for genomics techniques now make it possible to establish the genetic profile of a tumor. Targeted diagnosis of molecular abnormalities and allows to propose and specifically targeted direct therapeutic identified genetic alterations and supposedly responsible for tumor development. An analysis of tumor exome by next-generation sequencing (NGS) and provides information on genetic modifications of these tumors.

This study did not aim to evaluate a therapeutic strategy or treatment. The objective of this study is to evaluate the clinical benefit of an analysis of exome performed in current practice at the Centre Georges-François Leclerc from Dijon. The analysis will be performed by quantifying the number of patients undergoing therapeutic proposal based on the results of the analysis of the profile of the tumor.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* histological and cytological diagnosis of solid evidence of malignancy metastatic or locally advanced non-curable and non-curable
* Disease for which a treatment under the national standards do not exist or will not exist if it escapes the current treatment
* Availability of equipment or new tumor biopsy / puncture a feasible accessed injury (biopsiable disease), only if it is deemed necessary in the treatment by the investigator.
* Patient affiliated with a social security scheme
* Patient non opposition

Exclusion Criteria:

* No tumor material available for the establishment of the tumor profile.
* Patient refusal
* Psychiatric illness and / or patient condition compromising the understanding of the information or the conduct of the study
* Patient under guardianship or subject to major people protection regime
The Integrated Care Model for Homeless Mothers

The purpose of this study is to pilot test an adapted collaborative care model for homeless mothers with depression.

Homeless mothers are more vulnerable to Major Depressive Disorder (MDD) than comparable groups of impoverished mothers, with rates in recent community studies approaching 50%. Even though primary care offers an ideal venue to identify and manage depression among women who commonly fail to receive needed mental health services, rigorously tested primary care-based treatment strategies that address the needs of homeless mothers with depression are lacking. This study reports results on a pilot test and feasibility findings of a new intervention, the Integrated Care Model for Homeless Mothers (ICMHM), adapted from the collaborative care model for depression (CCM) to address unique aspects of care for homeless mothers who screened positive for depression during a shelter-based primary care visit.

Eligibility Criteria:
Inclusion Criteria:

* Mothers who are residing in emergency shelter
* 18 years of age or older
* Screen positive for depression
* Speak English or Spanish

Exclusion Criteria:

* Not pregnant
* Not currently receiving depression treatment
* Not currently psychotic
tDCS Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth

Negative symptoms, which include the loss of motivation, social withdrawal and reduced emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. These negative symptoms lead to significant functional impairment and enduring disability in these youth. At present, there are no established treatments for negative symptoms. Recent evidence from independent studies, however, suggests two promising novel treatment approaches for negative symptoms, transcranial direct current stimulation (tDCS), and computerized remediation strategies. The primary aim of this study is to evaluate if tDCS combined with a virtual reality-based computerized remediation (VR) is effective for treating negative symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms cause.

Negative symptoms, which include amotivation, social withdrawal and diminished emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. Negative symptoms lead to significant functional impairment and enduring disability in these youth regardless of subsequent conversion to psychosis. At present, there are no established treatments for negative symptoms. Recent evidence from independent studies, however, suggests two promising novel treatment approaches for negative symptoms, transcranial direct current stimulation (tDCS), and computerized remediation strategies, both of which have revealed significant therapeutic effects on negative symptoms in schizophrenia (SZ). tDCS involves delivery of a low intensity continuous electrical field to the frontal cortex. tDCS is very safe and well tolerated, and is currently being investigated as a treatment for several psychiatric disorders. tDCS is also Health Canada approved for the treatment of major depressive disorder. The primary aim of this randomized controlled trial is to evaluate if tDCS combined with a virtual reality-based computerized remediation (VR), administered three times per week for four weeks, is effective for treating negative symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms cause.

Eligibility Criteria:
Inclusion Criteria:

1. between the ages of 16 and 30;
2. meet CHR criteria for a psychosis risk syndrome determined by the Structured Interview for Prodromal Symptoms (SIPS);
3. have a Scale of Prodromal Symptoms (SOPS) negative subscale (SOPS-Neg) score of \> 11, with at least one negative symptom of at least moderate severity (i.e., ≥ 3)

Exclusion Criteria:

1. meet criteria for a current or lifetime psychotic disorder;
2. have an IQ \< 70;
3. a history of seizures or clinically significant neurological disorder that may contribute to prodromal symptoms.
4. have been involved in another treatment study in the past 4 weeks.
Growth of Infants Fed an Amino Acid Infant Formula

The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant
* Full-term (\>= 37 weeks gestation)
* Birth weight between \>= 2500 and \< =4500 g
* 0-17 days of age on enrolment (day 0 is day of birth)
* Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
* Study explained and written information provided with Caregiver demonstrating understanding of the given information
* Informed consent signed (parent/legal representative)

Exclusion Criteria:

* Congenital illness or malformation that may affect infant feeding and/or normal growth
* Suspected or known allergy to cow's milk protein
* Significant pre-natal and/or post-natal disease
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrolment
* Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
* Infant currently participating in another conflicting clinical study
* Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients

Remote monitoring of implantable cardioverter defibrillators (ICD) is a promising new development in ICD therapy and has been shown to be technically feasible and safe.While data on safety and feasibility of remote monitoring are in favour of this technology, patients´ treatment satisfaction has not been sufficiently investigated. To date, there is only one small, non-randomised study investigating patients´ treatment satisfaction in highly selected and highly motivated patients at the time of implantation and 12 months thereafter7. Therefore, the aim of the San Remo Trial is to investigate factors that are associated with patients´ willingness to accept the new method of follow-up on a broad basis of ICD recipients and to determine their treatment satisfaction with ICD therapy in a randomised, prospective trial.


Eligibility Criteria:
Inclusion Criteria:

* ICD indication according to current national or international guidelines
* Patient available for follow-up during study period

Exclusion Criteria:

* Clinically unstable medical conditions that require regular outpatient clinic follow-up
fMRI of Stress in Smoking Behavior

To examine the influence of current daily tobacco smoking on brain activation during stress, tobacco cue, and neutral relaxing conditions

Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with tobacco cues, stress and neutral/relaxing imagery. During each fMRI session subjects will participate in six imagery trials: 2 different neutral/relaxing, 2 different stress and 2 different tobacco cue scripts.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-50 years inclusive;
2. able to read and write English;
3. for women, being in follicular phase of menstrual cycle;

5) Tobacco dependent sample: smokes 10 or more cigarettes daily for the past year; Non-smokers, no tobacco consumption for more than one year and never having used tobacco daily.

Exclusion Criteria:

1. any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with possible exception of nicotine dependence) as determined by SCID interview;
2. use of any psychoactive medication within past four weeks;
3. any significant unstable medical condition such as asthma or heart disease for which increased cardiovascular reactivity during stress challenge might constitute a significant risk;
4. IQ\<70 based on past intelligence testing;
5. any metal in body that would pose a risk with MRI; and
6. claustrophobia that would interfere with MRI;
7. alcohol and drug use in the 72 hours prior to scanning, with the exception of tobacco;
8. pregnancy for women.
The Effects of Vibration and Pressure Interventions

This study aimed to evaluate two methods (pressure and vibration intervention) used to reduce pain during IM injections in children.

Objectives: This study was conducted to evaluate the effects of the Vibration and Pressure Intervention for reducing pain during intramuscular (IM) injections in children.

Design: The study was conducted via a randomized controlled design. Setting: The study population consisted of children in the five to 10 age group admitted to the emergency department of a public hospital (Samsun Education and Research Hospital) between August 2022 and October 2022 and who received an IM injection as part of the medical treatment in child emergency department.

Interventions: The study data were collected from the children, who were divided into Vibration Intervention group, Pressure Intervention group, and control groups.

Main outcome measures: The children's pre-procedure fear and anxiety levels were evaluated using the Children's Fear Scale (CFS), and Children' Anxiety Meter State. Then, their pain levels during the procedure were evaluated using the Wong-Baker FACES Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* had no diagnosed physical or mental disability or chronic illness;
* had no communication problems;
* received single injection,
* required seftriakson group of antibiotics for standardization; and received vastus lateralis muscle injection during the study.

Exclusion Criteria:

* Parents who were unable to collaborate in the fear and pain evaluation,
* overweight or underweight children (under the third or above the 97th percentile),
* children with any incision or scar tissue in the injection area,
* children who received a sedative, analgesic, or narcotic drugs (based on expert opinion) six hours before the procedure on the basis of parental statements and medical history
Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure

Background. To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF undergoing CR in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and rehospitalization rates due to HF (secondary outcomes).

Methods. A randomized controlled trial will be conducted in a sample of 80 patients referred to CR. Participants will be enrolled in a cardiological rehabilitation unit of a large university hospital in Italy and randomized (1:1) to the experimental intervention consisting of CR performed with high-quality immersive VR with PICO 4® Head Mounted Display headset and TREADMILL XR® software (Arm 1) or standard CR (Arm 2). Patients will receive 30-minute CR sessions twice a week for one month.

Results. Significant improvements in primary and secondary outcomes are expected in patients in the intervention group.

Conclusions. If proven to be effective, VR could be an innovative, safe, and easy digital health intervention to improve adherence to CR in patients with HF, as well as important clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years;
* clinically stable chronic HF diagnosis with left ventricular ejection fraction (LVEF) \< 40%

Exclusion Criteria:

* conditions that exclude exercise training (e.g., bone fractures);
* conditions that exclude VR use of VR (e.g., blindness and deafness
* severe cognitive impairment, documented with a score of 0 - 4 on the Six-item Screener;
* end-stage renal disease requiring dialysis;
* ascertained advanced pneumopathies;
* active neoplasms;
* rheumatic diseases.
The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System

Collect electrophysiological data during atrial fibrillation (AF) ablation procedures to assess the performance of a Signal Complexity Visualization algorithm designed to be integrated into the CathVision ECGenius® System.

A prospective, single-center, feasibility study using the CathVision ECGenius® system and a Signal Complexity Visualization Algorithm during radiofrequency (RF) ablation procedures to treat persistent AF.

Subjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.

The validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.
* Male or non-pregnant female aged ≥ 21 years.
* Able and willing to provide written informed consent prior to any clinical investigation related procedure.

Exclusion Criteria:

* Current participation in another investigational drug or device study that interferes with this study.
* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
* Life expectancy less than 12 month, in the opinion of the Investigator.
* Subjects who, in the opinion of the investigator, are not candidates for this study.
* Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.

The objective of this study was to compare the utility of etomidate and midazolam in helping patients to relax when there was a need for the placement of a ventilation tube by medics who were transporting patients to a hospital in an ambulance.

Study Objective: The objective of this study was to compare the utility of etomidate and midazolam for sedative facilitated intubation (SFI), without paralytics, in pre-hospital adult patients.

Methods: This prospective, double-blind, randomized trial was conducted with two ground pre-hospital Advanced Life Support (ALS) units. All patients age 18 or over transported by the two participating systems requiring pre-hospital SFI were eligible for participation. The ambulances were stocked with blinded numbered syringes, each containing either 7mg of midazolam or 20mg of etomidate. Contact with the Medic Command physician was not required and no paralytics were used. If sedation was not achieved with the study drug, medics could request additional sedation from a Medical command physician; only midazolam or diazepam were available outside of the study.

Eligibility Criteria:
Inclusion Criteria:

Under the study protocol, all patients age 18 or over transported by the two participating ALS systems, requiring pre-hospital Sedation Facilitated Intubation, were eligible for participation.

Exclusion Criteria:

Exclusion criteria were pregnancy and age less than 18.