cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Basic Life Support Education Among Teenagers

Basic life support (BLS) skills are crucial not only for healthcare workers but for all lay people as well. Timely recognition of out-of-hospital cardiac arrest and the initiation of BLS by bystanders before the arrival of healthcare personnel can improve survival.

There are several methods of spreading BLS skills and improve BLS skill retention among lay people. One of these methods can be educating school children. The introduction of mandatory BLS education in schools was very effective in some European countries to increase the rate of bystander BLS.

The current study aims to investigate the efficacy of a BLS training and BLS curriculum among high school children in Hungary. Moreover, the investigators would like to optimise factors influencing skill retention in this first responder group and aim to compare two types of teaching methods: feedback given by the instructor or software-based feedback on the efficacy of chest compressions during the course.


Eligibility Criteria:
Inclusion Criteria:

* High school teenagers participating in the education of Óbudai High School, Budapest
* Written informed consent received from participants and their parents to participate in the study

Exclusion Criteria:

* No written informed consent provided by the student or parent
* Any injury or health issue influencing the efficacy of BLS skill
Assessment of Pain, Occupational Fatigue, Sleep and Quality of Life in Nurses

The aim of the study is to evaluate the pain, occupational fatigue, sleep and quality of life in nurses and the relationships between them. 102 participants working as nurses were included in the study. Data on age, gender, height, weight, working year in the profession, weekly working hours, hand dominance, diagnosed diseases and marital status of the participants were collected. Subsequently, the questions included in the Nordic musculoskeletal questionnaire, occupational fatigue / burnout / recovery scale (OFER), sleep hygiene index (SHI) and World Health Organization quality of life scale (WHOQOL-BREF) questionnaires were answered by the participants.

Nordic Musculoskeletal Questionnaire: It is a scale that evaluates whether symptoms of pain, pain and discomfort have been experienced in the neck, shoulder, elbow, hand-wrist, waist, back, hip-thigh, knee-foot-ankle regions during the last 12 months and whether ordinary indoor and outdoor activities are hampered by these symptoms and whether there has been pain in the mentioned body areas for the last 7 days. It consists of 27 items and each item is answered as yes / no.

Occupational Fatigue Exhaustion Recovery Scale: It is a scale developed to measure occupational fatigue. It consists of 15 items in total and 3 sub-dimensions evaluating chronic fatigue (questions 1-5), acute fatigue (questions 6-10) and recovery (questions 11-15). Each item is scored between 0-6 points (0 = Strongly Disagree, 1 = Disagree, 2 = Somewhat Disagree, 3 = Neither agree nor disagree, 4 = slightly agree, 5 = Agree, 6 = Strongly Agree) by the participants. High scores in the chronic and acute fatigue sub-dimensions mean higher occupational fatigue, and higher scores in the recovery sub-dimension mean better recovery between working periods.

Sleep Hygiene Index: It is a scale that evaluates sleep hygiene. The frequencies of sleep hygiene-related behaviors are questioned in a total of 13 items with a Likert-type scale where each item is scored between 0 and 4 (0 = never, 1 = rarely, 3 = sometimes, 4 = often, 5 = always). Higher scores indicate worse sleep hygiene.

WHOQOL-BREF-TR: It is a scale that evaluates the well-being of individuals in 4 sub-areas in which physical health, psychological status, social relations and environmental conditions are questioned, and their general quality of life and health status with one question. Each item is scored on a 1-5 Likert-type scale. Sub-domain scores represent the quality of life in their field independently of each other. Higher scores indicate better quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Working as a nurse

Exclusion Criteria:

* Being under the age of 18
* Having a history of serious trauma and orthopedic surgery in the last 1 year
* Having a chronic severe internal and neurological disease
Brain Function and Decision-Making

This study is about how brain function and structure is different between two universities. Participant in this project will contribute to a better understanding of how universities affect the brain.

Some study details are purposely omitted at this time to preserve scientific integrity. Now that the study is completed, full details are included below.

The true purpose of this study was to investigate the psychometric properties of the two computer tasks that participants completed. Specifically, researchers wanted to know if they would be able to accurately measure motivated empathy. To better understand this, participants were asked to rate images of people expressing pain and were told that these were either students from their university or students from a different university. This was not the case. The faces shown were random images produced for a research study.

Researchers also wanted to know if they could accurately measure moral decision making and how those judgments relate to aggression. To examine this, participants were asked whether various scenarios were immoral and then asked about aggressive tendencies.

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate students aged 18 - 35 years of age
* No current or regular use of prescribed or illicit psychoactive drugs
* Free of major health problems (e.g., diabetes, HIV, Parkinson's disease)
* Free of a neurological or psychiatric disorders
* No current drug abuse (e.g., recreational drug use, average alcohol intake in excess of 4 drinks per day).
* Right hand dominant
* Free of claustrophobia
* Free of pregnancy or suspected pregnancy
* Absent MRI risk factors (e.g., implanted medical device, body mass index \> 35, braces)
* Free of medical conditions that render individuals with overly sensitive hearing
* No colorblindness

Exclusion Criteria:

• Not meeting the inclusion criteria listed above.
Is Self-transfusion Safe After Total Knee Arthroplasty in Terms of Nephrotoxicity of Gentamicin From Bone Cement?

Considering that the high local concentration of antibiotic from bone cement is delivered intravenously through the self-transfusion process, systematic toxicity has never been evaluated. In addition, the effectiveness of self-transfusion with the routine concomitant use of other modern blood-salvage strategies, like tranexamic acid, should be also assessed. Therefore we performed a randomized study to assess: 1) the safety of self-transfusion in TKA by comparing the gentamicin concentrations resulting from the use or not of autologous blood transfusion. 2) the efficacy of self-transfusion in TKA, with the concomitant administration of tranexamic acid.

The serum concentration of aminoglycosides has been measured in two groups of 20 patients each, after TKA, according to the use of self-transfusion. Hemoglobin, renal function and calculated blood loss were compared at several time points between groups.


Eligibility Criteria:
Inclusion Criteria:

* end-stage of knee osteoarthritis, who scheduled for unilateral primary TKA in our department

Exclusion Criteria:

* patients who had been treated with gentamicin within the past 10 days
* known allergies against the bone cement
* estimated glomerular filtration rate (eGFR) \<30ml/minute
* previous nephrectomy and history of renal transplant
* contraindications against tranexamic acid
Active Hexose Correlated Compound in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection

Background

Active Hexose Correlated Compound is assumed to have a positive effect on immunity, including induce a phagocytic response, reduce tumor resistance, and cytokine response including interferon-gamma and interleukins. Tuberculosis patients with concurrent Human immunodeficiency Virus (HIV) might have benefit when receiving active hexose compound during tuberculosis treatment

Purposes

1. To assess the clinical changes of patients who receive active hexose compound as an adjuvant to tuberculosis therapy in patients with HIV
2. To assess the difference of pro-inflammatory cytokines between standard therapy and active hexose compound adjuvant

Methods A clinical trial involving patients with Tuberculosis-HIV infection

Hypothesis

1. Clinical improvement is significantly different where the group who receive active compound will have the better clinical outcome
2. Lower proinflammatory cytokines are observed in people who receive active compound

Population :

Lung Tuberculosis patient with HIV Infection

Design :

Double-Blind Randomized Control Trial at the outpatient setting

Randomization Simple Randomization

Proposed Number of participants :

Using the difference between two independent means of duration to sputum conversion

1. Type 1 error 5%
2. Power of study 80%
3. Effect Size 0.5
4. Dropout rate 20% Total Participant 122

Proposed analysis

1. Time-to-event analysis using cox regression for the duration of sputum conversion and radiology resolution
2. Linear mixed model for continuous dependent variable

Eligibility Criteria:
Inclusion Criteria:

1. Newly-diagnosed Lung Tuberculosis case who will receive a 6-month regiment
2. Not Pregnant
3. Diagnosed with HIV

Exclusion Criteria:

1. Patient with liver dysfunction
2. Patient with drug-resistant
3. Severe Malnutrition
4. Refuse to be involved
Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients

Investigators are evaluating the feasibility, safety and early efficacy of administering a commercially available dietary supplement containing potato-based resistant starch to subjects undergoing allogeneic SCT (stem cell transplant). The intervention will begin immediately prior to the conditioning phase and continue through day 100. Investigators hypothesize that short term administration of a resistant starch is capable of increasing levels of butyrate within the intestine that will reduce rates of acute GVHD (Graft-Versus-Host Disease).


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing matched related and matched unrelated full intensity allogeneic HSCT.
* Age ≥ 18 years for the feasibility phase. Age ≥10 years old AND ≥50 kg for the phase II portion.
* Karnofsky \>70%, (Karnofsky Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 100 where 100 is "perfect" health and 0 is death.)
* Subjects must be able to swallow capsules/tablets
* Ability to understand and the willingness to sign a written informed consent
* Willingness to consent / co-enroll on BMT long term follow up study or HUM00043287 (UMCC2001-0234)
* Availability of an HLA matched related or matched unrelated donor

Exclusion Criteria:

* Patients with inflammatory bowel disease.
* Patients with a history of gastric bypass surgery.
* Patients with active Clostridium difficile infection at the time of study enrollment. Active infection is defined as a stool sample positive for Clostridium difficile toxin via EIA (enzyme immunoassay) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon.
* Patients actively enrolled on any other GVHD prevention trial.
* Any physical or psychological condition that, in the opinion of the investigator, would post unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures.
Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers

Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers

A Randomized, Single Blind, Single Dose, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intradermal Dosage Form of BMT101 in Healthy Male Volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Adults, 19 \~ 39 years of age
2. Body Mass Index (BMI) between 19 to 25kg/㎡ (19kg/㎡ ≤ BMI \< 25kg/㎡) and weight at least 50kg on the day of screening
3. Medically healthy with no clinically significant findings on vital signs during the screening period
4. Medically healthy with no clinically significant findings on physical examinations during the screening period

Exclusion Criteria:

1. Subjects with clinically significant medical or surgical history described below Clinically significant observations considered as unsuitable based on medical judgement by investigators

   * Skin disorder (psoriasis or contact dermatitis) which may affect absorption of the investigational product, or scar, skin abnormality, history of surgery (excluding simple appendectomy or herniorrhaphy) which can interrupt intradermal injections
2. History of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, respiratory, musculoskeletal or any other conditions which can be problems for pharmacokinetic evaluation
3. Donated blood or blood components or had been transfused plasma within 60 days prior to the day of screening
4. Tobacco use within 30 days prior to the day of screening
"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients.

Patients will be allocated at random to receive either right ventricular pacing or physiological pacing. Endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient.

Recruitment and pacemaker implantation will be carried out at each participating centre. The primary analysis will be intention to treat. The investigators will also perform an on-treatment analysis.

2048 patients are needed to detect the expected effect size with 85% power. A total of 2600 patients will be recruited to allow for patient drop-out and crossover.

500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of PICM (Pacing Induced Cardiomyopathy).

Patients entering the study will attend for implantation of a pacemaker device and be randomised to either right ventricular pacing or physiological pacing.

Patients at sites participating in echo sub-study will be informed of and given opportunity to consent to echo sub-study, this will be optional to them, even if they have consented to the main study.

Eligibility Criteria:
We will recruit patients who are referred for clinically indicated pacemaker implantation

Inclusion Criteria:

1. Adults aged over 18 with left ventricular ejection fraction \>35% and one or more of the following guideline based ventricular pacing indications:

1. Permanent or intermittent 3rd degree AV block
2. Permanent or intermittent Mobitz type II AV block
3. First Degree AV block with a pacing indication
4. Slow chronic Atrial Fibrillation or Proposed AV node ablation
5. Bifascicular block with a pacing indication
6. Trifascicular block with a pacing indication
7. Wenckebach with a pacing indication

Exclusion Criteria:

1. Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.
2. Pregnant women.
3. Unable to provide informed consent.
4. Those with comorbidity leading to a life expectancy \<1year.
Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma

Basal cell carcinomas (BCCs) are the most common form of cancer. The treatment of BCC can be surgical or topical for the low-risk subtypes. Topical treatments used for BCC are imiquimod and photodynamic therapy (PDT). Ingenol mebutate could provide a fast and easy topical therapy for BCC. Data regarding the treatment of BCC with ingenol mebutate are still limited. The investigators propose a pilot study to investigate the efficacy of 1 or 2 courses of ingenol mebutate 0,05%, on superficial and nodular BCC


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Histologically confi rmed, primary, previously untreated, nodular or superfi cial basal-cell carcinoma not arising on the face or scalp, measuring 1 to 4 cm (large axis)

Exclusion Criteria:

* Basal cell carcinomas of the scalp
* Basal cell carcinomas recurrent, sclerodermiform, infiltrant, metatypic
* Allergic patient to treatment products
* Patient treated with immunosuppressants, immunomodulators, systemic cytotoxic agents or local corticosteroids applied in the CBC area during the 4 weeks prior to the screening visit
Particulate Vs. Non-Particulate Steroid for Sacroiliac Joint Injection

This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain.

Patients who are screened for inclusion will be randomized into one of two groups; dexamethasone or methylprednisolone. Patients will report their pain immediately after the procedure to confirm the diagnosis of sacroiliac joint pain, then be followed for three months to compare the efficacy and safety of the two medications.

Eligibility Criteria:
Inclusion Criteria:

* Aged \>18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
* Unilateral low back/buttocks pain of at least 2 weeks.
* Patient reported 7 day average of numeric pain rating score (NPRS) low back/buttocks pain of at least 5/10 at baseline evaluation
* Clinical diagnosis of sacroiliac joint pain as diagnosed by a board certified Physiatrist including history of low back/buttocks pain and at least 2 positive physical exam findings (including positive fortin finger sign, pain with palpation of posterior superior iliac spine, positive FABER's test, positive Gaenslan's test, positive sacral distraction, positive thigh thrust, positive lateral compression, positive sacral thrust)
* Patient consents to sacroiliac joint corticosteroid injection in a shared decision-making process with the treating physician.
* 80% or more relief of index pain within first 5-15 minutes after injection

Exclusion Criteria:

* Clinical suspicion of alternative process is greater than clinical suspicion of sacroiliac joint pain
* Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
* Those involved in active litigation relevant to their pain.
* Those unable to read English and complete the assessment instruments.
* Those unable to attend follow up appointments
* The patient is incarcerated.
* History of prior sacroiliac joint fusion
* Progressive lower extremity neurologic deficit (from active radiculopathy, unhealed radiculopathy, or neuromuscular disease)
* Sacroiliac joint steroid injection within the prior 12 months
* 2 Positive lumbar medial branch blocks within the past 12 months
* Radiofrequency ablation of the lumbar spine within the past 12 months
* Lumbar facet steroid injections within the past 12 months
* Prior epidural steroid injection within the prior 3 months in any location within the spine.
* Possible pregnancy or other reason that precludes the use of fluoroscopy.
* Allergy to steroid, contrast media, or local anesthetics.
* BMI\>40.
* Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
* Active infection or treatment of infection with antibiotics within the past 7 days.
* Medical conditions causing significant functional disability (e.g., stroke, decompensated ---COPD, decompensated heart failure)
* Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
* Addictive behavior, severe clinical depression, or psychotic features.
Neptune Pad ® Compared to Conventional Manual Compression

BACKGROUND. Arterial access site complications remain the most frequent adverse events after percutaneous transluminal procedures. We investigated the safety and efficacy of the pro-coagulant wound dressing Neptune Pad ® compared to conventional manual compression for access site management after peripheral percutaneous interventions.

METHODS. We enrolled 201 consecutive patients and randomly assigned patients for Neptune Pad ® (n=100) vs. conventional manual compression (n=101). Patients were followed clinically until hospital discharge and by duplex ultrasound at 24 hours postprocedure for occurrence of access site complications. Time-to-hemostasis and time-to-ambulation were recorded, patients´ and physicians´ discomfort were measured using a visual analogue scale.


Eligibility Criteria:
Inclusion Criteria:

* All inguinal punctures (common femoral, superficial femoral and deep femoral artery, antegrade and retrograde access) were included.
* No specific limitations of anti-platelet or anti-coagulant medication were specified.

Exclusion Criteria:

* Patients with extreme obesity (BMI above 35 kg/m2) were not included according to the manufactures' recommendations.
* Furthermore, patients with known hypersensitivity to components of the device were not eligible