cyrilzakka/clinical-trials huggingface dataset:
Creating a New Health Promotion Module to Help the Indigenous People of Selangor Prepare for Disease X and Outbreaks

The goal of this cluster randomized trial is to develop and test a new method for preparing indigenous (locally termed as Orang Asli) households in Selangor, a state in Malaysia, for outbreaks and Disease X, a potential unknown infectious threat. It aims to determine if the new method, a health education package comprised of workshops, simulation exercises, and card game play sessions, can enhance the readiness of these families for such outbreaks.

The main questions it is looking to answer are:

1. Will the intervention package increase the level of preparedness for a Disease X and outbreaks among indigenous households in Selangor?
2. Will the intervention improve the awareness and attitudes of the indigenous people in Selangor towards outbreak preparedness?
3. Will it lead to more proactive preparedness actions by these households?

To evaluate the effectiveness of the intervention package, researchers will compare outcomes between two groups: the intervention group receiving both the intervention package and educational brochures on communicable disease prevention, and the control group receiving only the brochures.

Participants will:

1. Participate in the activities in the newly developed intervention package, which would include workshops, simulation exercises, and card game play sessions.
2. Answer surveys four times: before, immediately after, 1 month after and 2 months after the intervention, to measure any changes in their preparedness levels for an outbreak.


Eligibility Criteria:
Inclusion Criteria:

* Orang Asli ethnicity
* Malaysian citizen
* Age between 18 to 99 years old
* The head of the household, or the person who contributes to, or influences health-related decisions for the household
* Live in a household with at least three members
* Able to converse in Malay

Exclusion Criteria:

* Having physical or cognitive disabilities (e.g., blindness, deafness, schizophrenia and dementia)
* Having severe health conditions (e.g., respiratory and cardiovascular disease requiring oxygen support such as severe asthma/chronic obstructive pulmonary disease/heart failure and congenital heart diseases)
* Residing temporarily (less than 2 years)
* Intending to relocate to a different residence within the next 2 years
Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapyv

ABSTRACT Purpose: This research was done for the purpose of determining the impact of breast milk smell administered to term infants hospitalized in neonatal intensive care units (NICU) due to physiological jaundice on their bilirubin levels, length of remaining in phototherapy and comfort.

Material and Method: It is an experimental, randomisation, controlled research. Target population of the research consisted of a total of 72 term infants who were hospitalized in the NICU of Bilecik Bozuyuk Public Hospital and met the sample selection criteria. Our research includes two groups. Breast milk smell group and control group. The infants were assigned to the groups via randomization method. Sample assignment to the groups was performed using stratification and blocking methods. The infants meeting the research sample selection criteria were stratified according to their postnatal age and then assigned to each group equally (blocking) by lot. However, two infants in the control group were excluded from the research at the request of their parents as the research continued. Thus, the research was completed with a total of 72 infants; 37 in the breast milk smell group and 35 in the control group. In the research, the data were collected using "Personal Data Collection Form", "Phototherapy Follow-up Chart" and "Neonatal Comfort Behavior Scale". The data were analyzed using the SPSS (Statistical Package for Social Sciences) 21.0 (IBM corp. Relased 2012. IBM SPSS Statistics for Windows, version 21.0 Armonk, NY: IBM corp.) package software.


Eligibility Criteria:
Inclusion Criteria:

* The term baby (37-39+6 weeks) of the newborn according to the menstruation of the mothers
* Need to have phototherapy treatment for the first time
* Not taking analgesics and/or sedatives in the last 24 hours
* Body weight in the range of 2500 - 4000 g
* Postnatal age of the newborn greater than 48 hours
* Turkish Neonatology Society's approach, follow-up and treatment guideline for neonatal jaundice (2014) Being a medium and high risk baby according to the table of risk status determination of babies according to postnatal age and transcutaneous or total serum bilirubin values.
* Not taking any treatment or medication other than phototherapy treatment
* The mother and/or father accepting the study is having a baby.

Exclusion Criteria:

* Having a health problem other than physiological jaundice
* Findings such as tachypnea, fever
* Having an invasive procedure other than blood sampling once a day for babies
* Exchanged babies
* Babies with Rh and AB0 incompatibility
* Babies with elevated bilirubin levels earlier than 48 hours
* Discord with family
Positive End-expiratory Pressure and Esophageal Catheter Optimal Calibration Volume in ARDS Patients

The use of esophageal balloon catheter to estimate pleural pressure has gained renewed popularity in recent years. Indeed, measurement of transpulmonary pressure may allow a more pathophysiological-based approach to ventilator strategy in acute respiratory distress syndrome (ARDS) patients. Nevertheless, it is well known that esophageal balloon catheter derived parameters can be influenced by several patient-related or technical-related factors.

During a PEEP trial, the investigators will observe in-vivo the esophageal pressure and derived measurements obtained using different esophageal balloon calibration volumes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ARDS with a PEEP of at least 8 cmH2O
* Fraction of inspired oxygen not higher than 80%
* Intubated and ventilated in Volume Control Ventilation mode set by the attending physician according to clinical criteria
* Need of continuous sedation through intravenous anesthetics and full neuromuscular blockade

Exclusion Criteria:

* Been pregnant or breastfeeding
* Hemodynamic instability
* Presence of tracheobronchial fistula
* Known pneumothorax
* Leak in airway circuitry
* Presence of any kind of inhalator therapy (e.g. Heliox, nitric oxide, anesthetic conserving device)
* Recent history of nasal trauma or lesion of nasal cavity
* Recent history of esophageal, gastrointestinal, ENT, thoracic or cardiac surgery (less than 2 months)
* Known or suspected esophageal varices
* Congenital, acquired or drug-induced hemostatic disorder
* Thrombocytopenia (less than 50000/mm3)
* Recent history of Traumatic Brain Injury or thoraco-abdominal trauma (less than 1 months)
* Rib or sternal fractures
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes

Team Clinic is a new care approach for middle and high school aged patients living with T1D and their families. This study is a 15-month randomized control trial (RCT) that consists of Virtual Team Clinic Care appointments (primarily telemedicine, and in-person as necessary) and Virtual Team Clinic group appointments with a multidisciplinary diabetes care team. Assignment into 1 of 4 intervention groups Team Clinic Care vs. Standard Care which consist of either Virtual Team Clinic Group or no group.

Groups:

1. Standard Care - No Group
2. Standard Care - Virtual Team Clinic Group
3. Team Clinic Care - No Group
4. Team Clinic Care - Virtual Team Clinic Group Virtual Team Clinic group sessions will be facilitated by clinical care team (e.g., Registered Dietician, Social Worker, Registered Nurse, etc.)

   * Patients and parents will attend their own online session

Team Clinic is an innovative approach to addressing patient developmental, psycho-social, and familial challenges; while also tackling the medical infrastructure and multi-disciplinary care challenges encountered by middle school and high school aged individuals with Type 1 Diabetes and their caregivers. This new approach consists of Team Clinic Care appointments (primarily telemedicine, and in-person as necessary). The study incorporates Virtual Team Clinic group/medical group appointments with a multidisciplinary diabetes care team of diabetes care providers. Each group will have a special theme (thematic group visits) and learning experience aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. Part of the goal of VTC is to spend less time in clinic while still receiving important diabetes education, support, and medical care.

Eligibility Criteria:
Inclusion

1. Diagnosis of type 1 diabetes \> 6 month duration
2. Grades 6th, 7th, and 8th ,9th, 10th, 11th, 12th at time of intervention
3. Not currently participating in other group interventions
4. English speaking

Exclusions

1. Severe behavioral or developmental disabilities in parent or child
2. Severe psychological diagnoses in parent or child that would make group participation difficult
3. Significant comorbid medical conditions that would make the patient non-eligible for group participation (e.g. cystic fibrosis, uncontrolled thyroid disease)
4. Non-English speaking
Efficacy and Safety of RAD001 in Treating Plexiform Neurofibromas (PN) Associated With Neurofibromatosis (NF1)

This study was to evaluate the antitumor activity and safety of RAD001 in patients with Plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1).

The aim of the study was to :

1. determine whether RAD001, administrated orally daily on a continuous dosing schedule might:

   1. Increases time to disease progression (TTP) based on volumetric MRI measurements in children and adults with NF1 in inoperable documented progressive PN (stratum 1).
   2. Results in objective radiographic responses based on volumetric MRI measurements in children and adults with NF1 and inoperable PN in the absence of documented radiographic progression at the trail entry (stratum
2. To evaluate the tolerability and toxicity of chronic RAD001 administration in this patient population as assessed by the NCI Common Toxicity Criteria, version 4.0.

Approximately 20 patients were to be enrolled to receive everolimus in an open label manner. A total of 9 patients were enrolled to either Stratum 1 or Stratum 2.

The study was open for enrollment up to 2 years. Because the target enrollment was not achieved in this period, study was terminated with less patient than planned.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically definite diagnosis of NF1 according to the NIH consensus conference criteria.
2. Patients must have PN that have the potential to cause significant morbidity, such as lesions that could compromise the airway or the great vessels, lesions that could cause nerve compression, lesions that could result in major deformity or significant cosmetic problems
3. Measurable disease: patient must have at least one measurable PN amenable to volumetric MRI analysis.

Exclusion Criteria:

1. Chronic treatment with systemic steroids or another immunosuppressive agent.
2. Evidence of an active optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer requiring treatment with chemotherapy or radiation therapy.
3. Clinical evidence of significantly impaired lung function
4. Pregnancy or breast feeding.
5. Prior therapy with mTOR inhibitors (e.g.sirolimus, temsirolimus, everolimus).
6. No contraindications for MRI assessments

Other protocol-defined inclusion/exclusion criteria may apply
Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain

Chronic pelvic pain (CPP) is a common presenting complaint affecting approximately 15-40 % of women aged 18-50 in western countries and 5-43% of women in most developing countries. It is debilitating and has a large socio- economic impact, with a 45%reduction in work productivity, and a 15% increase in absence from work in women with the condition. Botulinum neurotoxin type A (BoNTA) has been suggested to improve pain in muscle spasm, its role in CPP secondary to pelvic floor spasm has gained increasing interest. However, clinicians do not have a diagnosis tool to evaluate the CPP and the BoNTA treatment results.

Design and develop an efficient and simple tool for the diagnosis and detection of pelvic floor muscle (PFM) dysfunction based on superficial electromyography (EMG) and perform 25 EMG registrations sessions in healthy patients and 25 EMG sessions in patients diagnoses with PFM that will be treated with BoNTA to and study the EMG signal before and after BoNTA administration.


Eligibility Criteria:
Inclusion Criteria:

I. Chronic pelvic floor pain (CPD) is defined as pain lasting longer than six months, with absence of proven organic cause and finding of component myofascial present that has been refractory to conventional medical treatment (NSAIDs) II. Sign Informed Consent for the administration of BoNTA III. Authorize to participate in the study IV. Patients who agree not to become pregnant during the duration of the study, using effective contraceptive methods

Exclusion Criteria:

I. Minor II. Pelvic active infection III. General or pelvic malignant disease IV. Psychiatric disease V. Contraindication for the administration of BoNTA VI. Patients who participate in another clinical trial and have been administered a investigational medication within 30 days prior to the planned start of the treatment.
Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters

In several diseases in which muscle weakness is a determining factor for morbidity and mortality, inspiratory muscle training has been shown to be useful in improving the function of ventilatory muscles, delaying or minimizing the development of complications due to the reduction of inspiratory muscle strength.

The breath-stacking technique emerges as an easily applicable alternative, and it can be used in poorly collaborative patients. The technique described in the literature aims to increase pulmonary volumes.

This gain occurs with the coupling of a silicone mask on the patient's face, a unidirectional valve and with the expiratory branch occluded. Thus, inspirations occur sequentially in this medium, generating pulmonary hyperinflation and increasing the contractility power of the expiratory muscles, which are fundamental for coughing. This hyperinflation also improves the peripheral air distribution in the lungs by increasing intrathoracic pressure.

The objective of this study is to evaluate the effect of the breath-stacking (BS) technique on the ventilatory muscle strength of young and healthy individuals.

Initially, participants will be submitted to a learning session on the evaluation of ventilatory muscle strength and the breath-stacking technique. Between 24-72 hours after the learning, the evaluation of the muscular muscular strength will be performed through the maximal inspiratory pressure (MIP) and the maximum expiratory pressure (MEP). PI max will be measured from a maximum expiration; While PE max will be measured from a maximum inspiration, using a digital manovacuometer (MVD 300®)

Eligibility Criteria:
Inclusion Criteria:

* No signs and symptoms of pulmonary diseases, normal ventilatory muscle strength and agreement to participate and sign the informed consent form.

Exclusion Criteria:

* Presenting neuromuscular diseases, claustrophobia, ruptured eardrum, history of spontaneous pneumothorax and playing wind instruments or being a singer. Sample loss will be considered as non-attendance at all training sessions.
Pediatric Glittre ADL-test in Children With Asthma

The aim of the study is to investigate reliability, validity, of the Glittre ADL Test in children with Asthma.

The TGlittre-P is an adaptation of the TGlittre test for pediatric patients. It consists of completing a circuit while carrying a backpack with a variable weight of 0.5 kg to 2.5 kg, according to the child´s age and sex. This weight range follows the guidelines of the World Health Organization, which states that the younger the female child is, the lighter the backpack should be, in order to assure the school children´s health condition. The following tasks should be carried out; from a sitting position, the child stands up and walks along a 10m-long flat course, going up and down a 2-step rise (17 cm high x 27 cm wide) about halfway along that distance, to reach a bookshelf with three 0.5 kg objects (i.e. colorful plastic bowling pins filled with sand). The objects are placed on the top shelf at eye level, which should be removed, one by one, to the lower shelf at the level of the umbilicus, and then to the ground. Next, the objects should be placed on the lower shelf and then back to the top shelf. The child walks back along the same route. (S)he sits down, stands up and immediately starts the next lap. The following verbal instructions are given during the test: "sit" and "stand." The time required to walk five laps is registered; the less the time spent, the better the performance is. The test performance was evaluated by comparing the patient´s data with the data predicted by the equation, in his study with healthy children. The equation for girls is "time in TGlittre-P = 3.781-0.083 x AGE"; and boys, "time in TGlittre-P = 4.025-0.123 x AGE".

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 6-14 years with a diagnosis of Asthma
* Task-oriented and co-operative patients without any musculoskeletal, rheumatic, neurological, hearing and visual diseases and without pulmonary exacerbation at the time of data collection will be included in this study.

Exclusion Criteria:

-
Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy

The aim of this study is to investigate the effectiveness of virtual reality-based motion therapy in peripheral nerve injuries in the hand.


Eligibility Criteria:
Inclusion Criteria:

* ıt was operated in the early period with the diagnosis of peripheral nerve injury in the postoperative hand.
* clinical impression was made.
* out patient with median, ulnar, and radial nerve repair.
* completed the 6th postoperative week.

Exclusion Criteria:

* Those who have communication problems and users
* With the musculoskeletal system, the additional passage, rheumatological, etc., where they are located.

those with the disease

- Patients with multiple traumas
Changes in Serum Creatinine Levels Can Help Distinguish Hypovolemic From Euvolemic Hyponatremia

Retrospective study that analyzes the changes in serum creatinine as a tool to correctly classify the volemic status volemic status (euvolemia vs hypovolemia) of the patients with hyponatremia.

This study evaluates the usefulness of the changes in serum creatinine in differentiating between euvolemia and hypovolemia in hyponatremic patients. Changes in serum creatinine were retrospectively analyzed . The latter was calculated subtracting the serum creatinine value of eunatremia from that of hyponatremia, and was categorized as an increase when it was "positive", or "decrease/no change" when it was negative or equal to zero. The percentual change in serum creatinine was also calculated.

Two groups of patients were selected for the current study. First group was conformed by patients with hypovolemic hyponatremia, and second group by patients with euvolemic hyponatremia. Data from eunatremia as well as the hyponatremic episode were collected. Both groups were matched in Receiver operating characteristic curve analyzes where both arithmetical and percentual changes in serum creatinine were assessed and cut-off points were selected for an additional Odd Ratio analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypovolemic hyponatremia secondary to any cause
* Patients with euvolemic hyponatremia caused by Syndrome of inappropriate antidiuresis
* Complete clinical volemia assessment during hyponatremia.
* Presence of serum creatinine measured in eunatremia as well as in hyponatremic episodes.

Exclusion Criteria:

* Pregnants.
* Patients with a prior history of diabetes, advanced chronic kidney disease (glomerular filtrate rate below 30 ml/min), cirrhosis, or heart failure were excluded.
* Patients with hypervolemic hyponatremia.
POWERPLAY Phase 2: Development and Evaluation in Male-dominated Workplaces

With funding from the Alberta Ministry of Labour (Grant #095244772), a program called POWERPLAY (www.powerplayatwork.com), designed to promote men's health at work, will be evaluated in workplaces in Alberta.

In year 1, this project includes two main research components: 1. A pragmatic (real world) study will be conducted employing a quasi-experimental (not a randomized controlled trial), before and after design to evaluate the effectiveness of the POWERPLAY program. 2. An integrated set of research activities (systematic review, sleep behaviors and consultation groups) will be used to provide the basis for developing recommendations for promoting sleep health in male-dominated workplaces, and inform the development and testing of a POWERPLAY sleep health module (REST-UP) in Year 2.

Eligibility Criteria:
Inclusion Criteria:

* Men employed in participating workplaces, full-time or part-time, in any position within the organizations.

Exclusion Criteria:

* Although females may participate in the POWERPLAY program and surveys, they will not be included in the evaluation.