cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Implementation of CARD for School-Based Immunizations

A multi-faceted knowledge translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - was developed to improve the vaccination experience of students at school. CARD is a framework for delivering vaccinations that is student-centred that promotes coping. This study will examine the feasibility of CARD implementation procedures and measures in the school vaccination program in Calgary, Alberta for use in a larger cluster trial.

Vaccination is estimated to have saved more lives in Canada over the last 50 years than any other single intervention and is considered one of the most important advances in the prevention of disease. One major drawback of vaccination, however, is that the usual route of administration involves a painful needle injection. In students undergoing school-based mass vaccinations, vaccine injections frequently cause sever distress and fainting, with some serious injuries resulting from fainting. Concerns about pain and/or needle fear are also directly responsible for vaccine refusal in this population.

An evidence based clinical practice guideline for mitigating vaccine injection pain, fear and fainting has been developed, however, it is not yet implemented across different school-based vaccination settings and students are not benefiting from the research evidence. In a prior small-scale project, investigators developed and implemented a multi-faceted knowledge translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - in some schools in a small public health region in Niagara, Ontario. CARD is a framework for delivering vaccinations that is student-centred and promotes coping. It integrates recommendations from the guideline in two separate components of the vaccination delivery program: 1) pre-vaccination day preparation, and 2) vaccination day activities. Investigators found preliminary evidence of acceptability, appropriateness, satisfaction and clinical effectiveness of CARD when used in grade 7 students in Niagara.

In this study, investigators plan to determine the feasibility of implementing CARD in a diverse and more complex public health region in Calgary, Alberta. Specifically, investigators will determine recruitment rates, adherence to CARD protocol, response rates for questionnaires, acceptability, appropriateness (fit), and satisfaction. The results will inform a future cluster trial.

Eligibility Criteria:
Inclusion Criteria:

* grade 9 student eligible for vaccination at school
* public health staff in community health centre involved in the study
* school staff in a participating school involved in school vaccination program
* parent of a student eligible for vaccination at school

Exclusion Criteria:

* unable to understand and read English
Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds)

This study is designed to assess the effectiveness of the video-based intervention over and above current standard practice for pain control in the pediatric emergency department (ED). This is a single-center trial based at the IWK Health Centre. The primary outcome will be based on the Child-Adult Medical Procedures Interaction Scale (CAMPIS) coding of the video-taped pain response of the research participants (3-5 years old).

The purpose of this study is to determine if the pain and anxiety that children experience when they have venipuncture procedures performed can be reduced by a video-based distraction and coping strategy intervention. An instructional video has been designed to educate parents and children about what is going to happen during the venipuncture procedure, to teach coping skills that can be used before and during the painful procedure, and to provide distraction during the procedure by using an entertaining video segment.

Approximately 168 children (3-5 years of age) who are seen in the IWK ED requiring venipunctures for blood collection or IV starts will be randomized. Parent and child training in distraction and coping strategies will be provided by means of a self-administered video-delivery via a portable DVD player. Fifty percent of the eligible participants will receive the distraction and coping strategies intervention and 50% will receive the standard medical care provided by the IWK ED. Those receiving standard care will be evaluated for outcome results and then be compared to the intervention group. It is expected that children who receive the intervention will report less pain and anxiety associated with venipunctures than those who receive standard care.

Eligibility Criteria:
Inclusion Criteria:

Participants will be eligible for this study if they:

* Are between 3-5 years of age
* Are presenting in the IWK Emergency Department requiring venipuncture for blood collection or intravenous (IV) initiation.
* Are able to read and speak English
* Provide written parental authorization

Exclusion Criteria:

Participants will be excluded for this study if they:

* Are in critical condition as determined by ED staff
* Are in significant pain for other reasons other than the venipuncture
* Have severe cognitive delay
* Require sedation for the venipuncture as determined by the ED staff
Effects of Parenteral Nutrition With Different Lipid Emulsions in Preterm Infants

Previous studies have suggested that olive oil-based emulsion is safe and well tolerated in preterm infants, a showed efficacy and a good clinical and biological safety profile. The objective of this study was to assess the effects of a new olive-oil based lipid emulsion compared with the traditional lipid emulsions.

For a number of years, lipid emulsions have been used in the nutritional support of surgical and critically ill patients, with the aim of supplying substrates to meet energy demands and providing building blocks for wound healing and tissue repair. Two types of lipid emulsions are currently used for adult as well as pediatric patients: one lipid emulsions prepared from soybean oil that are composed of long-chain triacylglycerols (LCTs), 62% of which are polyunsaturated fatty acids (PUFAs), and the other lipid emulsions composed of 50% medium-chain triacylglycerols (MCTs) and 50% LCT soybean oil. A new lipid emulsion prepared from a mixture of soybean oil and olive oil contains only LCTs and has a lower proportion (20%) of PUFAs and 60% monounsaturated fatty acids (MUFAs). There are so many investigations with olive oil-based emulsion including in-vitro studies, animal studies, and infusion studies in healthy subjects and in various patient groups. In-vitro and animal studies demonstrate that the impairment of immune function, especially of T cell responses, that occurs with soybean oil-based emulsions is avoided with ClinOleic. Studies in infants and adults have consistently shown that olive oil-based emulsion increases the oleic acid content of blood lipids and that it avoids the depletion of long chain n-6 PUFA derivatives of linoleic acid that is seen with soybean oil-based emulsion. The less unsaturated nature of olive oil-based emulsion compared will possibly decrease oxidative stress. Further studies are required to test their beneficial effect from olive oil consumption in preterm infants.

The investigators designed a double-blind, randomized clinical trial to performed the effect of lipometabolism, oxidative stress and clinical outcomes of olive oil , MCY/LCT and LCT lipid emulsions.

Eligibility Criteria:
Inclusion Criteria:

* Infants of both genders
* Hospitalized
* The parent of the infant agreed to participate by signing an informed consent form
* Infants admitted hospital within 72 hours after birth(gestational age\<37 weeks)
* Birth weight \<= 2000g
* No PN support contraindications
* Parenteral nutrition for 14 days or more
* The parent of the infant is to sign an informed consent form prior to enrollment

Exclusion Criteria:

* Receiving PN before screening
* EN caloric\>10%
* Obstruction jaundice
* Suspected or identified biliary tract atresia
* Neonatal hepatitis
* Infants with liver markers \>2 times normal levels
* Infants with renal markers \>2 times normal levels
* Congenital metabolic situations
* Identified as having major chromosomal disease
* CMV, virus hepatitis and syphilis infection
* Congenital or acquired immune deficiency
Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit

The primary objective of this monocenter randomized controlled trial is to assess the efficacy of aromatherapy to prevent delirium in patients hospitalized in an intensive care unit.

Secondary objectives:

1. To assess the efficacy of aromatherapy on :

   * the level of consciousness,
   * pain,
   * the duration of mechanical ventilation,
   * the occurence of an accidental extubation,
   * the length of stay in the intensive care unit,
   * the cumulative duration of delirium episodes,
   * the time until first episode of delirium,
   * the use of neuroleptics.
2. To determine the factors influencing the efficacy of aromatherapy.
3. To assess the safety of aromatherapy.

Conduct of research:

After inclusion, patients will be randomized between the aromatherapy and control groups. Treatment will be started on the same day as randomization.

Aromatherapy treatment will consist of a dermal application on the feet of a mixture of essential oils.

Control treatment will consist of a dermal application on the feet of apricot vegetable oil.

The mixture of essential oils (aromatherapy group) or vegetable oil (control group) will be applied to the arch of the foot by massage, every eight hours, at a rate of six drops per application (3 drops per foot).

Treatment will continue until the patient is discharged from the intensive care unit or no later than 15 days after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient hospitalized in an intensive care unit for an expected duration of at least 24 hours
* Patient requiring mechanical ventilation with initial therapeutic sedation adapted secondarily for comfort sedation, defined by a RASS score target between -2 and 0
* Patient affiliated to/beneficiary of a social security scheme

Exclusion Criteria:

* Allergy to essential and/or vegetable oils
* Palliative sedation
* Foot skin injury contraindicating the application of an oil
* Moribund patient or expected death
* History of dementia
* Participation to a RIPH-1 study
* Pregnant or breastfeeding woman
* Patient under legal protection
* Patient deprived of liberty by judicial or administrative decision
Prediction to Detect Pre-DM/DM in a Chinese Population

This project will compare the sensitivity and specificity of different screening criteria or recommendations to detect pre-diabetes or diabetes mellitus in a Chinese population, using point-of-care hemoglobin A1c.


Eligibility Criteria:
Inclusion Criteria:

* age ≥25 years old
* with no previous diagnosis of DM
* Chinese.

Exclusion Criteria:

* a history of cardiovascular diseases including any type of stroke, ischemic heart disease, atrial fibrillation, and/or peripheral vascular disease
* severe mental or physical disease or language barriers that limited data collection
Preoperative Educational Videos on Maternal Stress Whose Children Received Congenital Heart Disease Surgery: During COVID-19 Panic

During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more after education, and until the day of discharge. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more on the discharge day if their child had surgical or post-surgical complications.

Aims and objectives: During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur.

Background: Mothers experience uncertainty, anxiety and depression if their children undergo conditions mentioned above. Such stress would be more during COVID-19 panic. Design: A randomized control-group pretest-posttest design. The CONSORT checklist is used. Methods: During COVID-19 panic, in a teaching hospital, 120 mothers whose children underwent first elective surgery for congenital heart disease were randomly divided into group 1: 60 mothers receiving routine education plus digital video disk before surgery; and group 2: 60 mothers receiving routine education. Between groups, mothers' uncertainty, anxiety and depression levels were compared (1) before education, (2) after education (before surgery) and (3) on the discharge day. Among mothers whose children had surgical or post-surgical complications, the effect of watching the digital video disk on uncertainty, anxiety and depression at discharge day was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Mothers, whose children underwent first elective cardiac surgery for congenital heart disease
* Mothers should have been the primary caregivers
* Mothers able to communicate effectively, either orally or in writing

Exclusion Criteria:

* Mothers of children with genetic disorders
* Mothers of children with non-cardiac congenital anomalies
* Mothers of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and \* \* Mothers of children with chronic lung diseases
Evaluation of the Treatment Response in Breast Cancer Related Lymphedema

This study aims to evaluate the effects of the treatment for breast cancer lymphedema. After taking a detailed history and giving a physical examination, breast cancer related lymphedema patients(n:30) will be informed and will be given Complete Decongestive Therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise. Patients will be evaluated with limb volume, lymphedema index acquired through bioimpedance device, QuickDASH for upper extremity function, hand dynamometer for upper extremity grip strength and CLUE(Breast Cancer-Related Lymphedema of the Upper Extremity standardized clinical evaluation tool) scoring for lymphedema before and after the intervention. The values will be compared in order to show whether there are significant differences between before and after scores, and whether CLUE score is correlated with the other indicators of breast cancer related lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral lymphedema of the arm after mastectomy for breast cancer

Exclusion Criteria:

* Bilateral lymphedema
* Primary bone tumor and/or metastasis
* Patients with ongoing radiotherapy
* Circulation disorders of the upper extremity(eg; peripheral vascular disease, thrombosis)
* Patients with infectious lymphedema/elephantiasis
* Presence of local infection in upper extremities(cellulitis) and/or presence of severe systemic infection
* Carcinomatous lymphangitis
* Congestive heart failure(NYHA class 3 or 4)
* History of prosthesis on upper extremities
* Use of drugs which may alter the fluid or electrolyte balance
Bicycle Exercise Echocardiography to Assess Physiological Significance of Mitral Annular Calcification

Many people develop calcium deposits in the heart as they get older. One of the common places for this to occur is the mitral annulus, the band of tissue that supports the mitral valve (one of four heart valves). The purpose of this study is to examine effects of these deposits (termed mitral annular calcification or "MAC") on a person's ability to perform exercise. The research team will use ultrasound of the heart (Doppler echocardiography) to study people with MAC while they exercise on a specially designed bicycle.

Mitral annular calcification (MAC) involves build-up of calcium in the mitral annulus, the fibro-muscular band which supports the mitral valve. The annulus aids in valve function, contracting in early systole (contraction phase) and bringing the valve leaflets together. In diastole (filling phase) it enlarges allowing blood to flow freely across the valve. Calcification stiffens the annulus and can extend onto the valve leaflets stiffening them. When severe, MAC impairs flow across the valve (mitral stenosis). This is characterized by a pressure gradient across the valve which can be detected by Doppler echocardiography (ultrasound).

Routine Doppler echocardiography is performed at rest when heart rates and flow across the mitral valve are low. Thus, even with severe MAC, there may only be a small pressure gradient present. However, with exercise these gradients can rise rapidly, leading to symptoms such as fatigue and shortness of breath.

MAC is associated with aging and is becoming more prevalent. Our hypothesis is that MAC is a common cause of shortness of breath with exertion. Further, the investigator believes this is under-appreciated because routine Doppler echocardiograms are done at rest. Therefore, the investigator will study adult subjects with moderate to severe MAC during bicycle exercise. Doppler echocardiography will be used to measure both the resting gradient across the mitral valve and changes with exercise. Symptoms will be measured by Borg Perceived Exertion scale.

If the research team is successful, the research team expects to demonstrate convincingly that this commonly encountered finding on Doppler echocardiography is an important cause of patient symptoms.

Eligibility Criteria:
Inclusion Criteria:

* At least moderate mitral annular calcification as judged by a previously published semi-quantitative echocardiographic score
* Over 18 years of age
* Able to use the semi-supine exercise bicycle
* Should be able to give informed consent.

Exclusion Criteria:

* Oxygen dependent lung or cardiac disease
* Moderate or greater aortic valvular disease
* Moderate or greater mitral regurgitation
* Reduced left ventricular ejection fraction, \<35%
* Any diagnosed coronary disease
* A resting mean gradient of ≥10 mmHg across the mitral valve.
Effect of Red Grape Cells (RGC) Powder Consumption on Measures of Aerobic Fitness and Mood

This is a 3-arm double blind placebo controlled study to investigate the effect of Red Grape Cell (RGC) powder containing all the matrix of polyphenols that can be found in red grapes. polyphenols have several beneficial effects on various body systems, are present in many edible foods, and are considered safe for human consumption by regulatory authorities. Animal and human studies suggest a potential for polyphenol-rich compounds in enhancing mitochondrial activity and exercise capacity. However, the effect of RGC on exercise performance in humans had not yet been tested. A special population where increasing performance is highly sought are competitive athletes. The aim of the current study is to investigate the effect of RGC on measures of aerobic fitness, body composition and mood in trained male cyclists


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years, men only
* Active in cycling training group
* Willingness to avoid regular use of NSAIDS (Advil, Nurofen, etc.) and aspirin for the entire study period
* Without a history or evidence of significant cardiovascular, hepatic, renal, respiratory, hematopoietic, gastrointestinal disease, endocrine, metabolic, psychiatric or psychological disorders;
* Willingness to avoid regular ingestion of any foods containing peanuts, bilberries, blueberries, cranberries, strawberries, raspberries, grapes, grape juice, cocoa powder, dark chocolate, red wine, over-the-counter medications, herbs, or supplements throughout the entire study, and to record and report any occasional consumption of such substances

Exclusion Criteria:

* Any acute medical situation (e.g., acute infection, nausea and vomiting, diarrhea) 48 hours prior to initiation of the study, which is considered of significance by the principal investigator.
* Any known chronic medical condition (will be determined by the principal investigator)
* History or evidence of alcohol or drug abuse
* Any gastrointestinal surgery other than appendectomy or herniotomy;
* Current use of over the counter or prescription weight loss medication
* Current use or within the last 30 days, any cholesterol lowering medications (statins, fibrates, red yeast rice, niacin).
* Known allergy to casein and/or soy.
* Subjects who had participated in a drug trial 3 months before initiation of the study;
* Non-cooperative subjects or unwilling to sign an informed consent and participate in the study
Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation

The aim of this study is to evaluate the correlation between the fat infiltration of the lumbar multifidus muscle and several parameters including the severity of the lumbar foraminal stenosis. The investigators will analyse lumbar MRI of patients previously included in a database of patients suffering from low back pain. Foraminal stenosis, muscle fat infiltration and other imaging lumbar parameters will be studied by 2D and 3D manuel segmentation, semi-automatic segmentation. Correlations between factors influencing the muscle fat infiltration will be studied by univariate and multivariate statistical analysis.


Eligibility Criteria:
Patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted, for who the following parameters are available: lumbar 3D MRI with T2 weighted sequences, informed consent.
Skeletal and Dental Maturational Stages in a Sample of Egyptian Subjects With Cleft Lip and Palate Deformity

The aim of this research is to evaluate the skeletal and dental maturation of cleft lip and palate patients in a sample of Egyptian population using the CVM as indicator for the skeletal maturation and the Demirjian method as indicator for the dental one when compared to a group of Egyptian non-CLP subjects of the same age.

Chronological age (CA) is not considered an accurate method for assessing the stage of physical or growth development of an individual in childhood or adolescence. For that reason, skeletal and dental maturation can be used in order to examine the rate of physical maturation of the population. Cervical vertebral maturation (CVM) method uses lateral cephalometric radiography to evaluate skeletal maturity. It is considered the preferable method due to its advantage of avoiding unnecessary extra radiation. The CVM method developed by Baccetti et al. (2005) depends on the morphology of the three cervical vertebrae (C2, C3, and C4), which divided skeletal growth into six stages of based on the morphology of the previously mentioned cervical vertebrae. The Demirjian method is considered as one of the most worldwide used method for assessment of the dental maturation due to its reliability. It depends on panoramic x-rays through which the dental developmental stage of 7 lower left teeth appears, and according to the gender of the patient the sum of values of the teeth will be transform to age through the standard tables of Carmen M. Nolla; 1960.

Eligibility Criteria:
Inclusion Criteria:

(1) Subjects with non-syndromic CLP aged 6-18 years. (2) Subjects with no CLP deformity, aged 6-18 years. (4) Patients having complete records comprising dental/medical history and a lateral cephalometric and panoramic radiograph.

(5) No congenitally missing teeth in the mandible. (6) No previous history of trauma to the face, neck.

Exclusion Criteria:

* Radiographs of poor quality.
* Any growth or hereditary or systematic diseases or syndromes
* Any trauma or fracture of the jaw that might have affected the normal growth of permanent dentition.