cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents Health in a Persistent Poverty Area

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to wait-list control at post intervention on changes in primary child outcomes (HbA1c, and vegetable intake), to examine the effects of the BB intervention compared to wait-list control at 9-month post intervention on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)),to examine the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes at 9-month post-intervention, using within-subject analyses, examine and compare the long-term and dose-response effects of the BB intervention strategies on diet, adiposity, and metabolic outcomes at 21-month follow-up in the children and to explore the moderating effects of social and environmental variables on program effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* enrollment of 100 1st, 2nd, and 3rd grade students
* high proportion of children participating in the free and reduced lunch (FRL) program (\>70%)
* willingness to implement a coordinated school health (CSH) program

Exclusion Criteria:

* Prior participation in BB in the previous school year
* children or parents identified as special needs per school; or having any physical, cognitive, or psychological disability that would prevent participation in evaluation measures
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency

OBJECTIVES:

I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone, for patients with primary adrenal insufficiency (Addison's disease).

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by age.

Patients are randomly assigned to androgen replacement therapy with daily dehydroepiandrosterone (DHEA) or placebo for 6 months. All patients may receive 6 additional months of DHEA following randomized therapy.

Women on hormonal replacement therapy may receive concurrent conjugated estrogens or oral medroxyprogesterone.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Primary adrenal insufficiency (Addison's disease) Serum dehydroepiandrosterone less than 0.5 nmol/L --Prior/Concurrent Therapy-- No concurrent investigational drug Stable glucocorticoid/mineralocorticoid dose over past year required --Patient Characteristics-- Hepatic: No hepatic disease Cardiovascular: No vascular disease No thrombotic disorder No angina No elevated blood pressure on 2 readings taken 15 minutes apart in 1 visit, i.e.: Systolic greater than 165 mm Hg OR Diastolic greater than 95 mm Hg Other: No clinically significant medical abnormality No gallbladder disease No malignancy No estrogen- or androgen-dependent neoplasia Benign prostatic hyperplasia eligible No other endocrine disease Controlled thyroid disease with normal thyroid-stimulating hormone eligible Mammogram required within 1 year prior to entry for women aged 40 and over No clinically significant abnormality No undiagnosed vaginal or uterine bleeding within 6 months prior to entry Pap smear required within 1 year prior to entry No dysplasia (squamous intraepithelial lesion low-grade or higher)
Spinal Anesthesia - Intraocular Pressure

We aim to investigate the effect of spinal anesthesia on intraocular pressure.

Spinal anesthesia provides adequate anesthetic conditions for many operations. These operations include orthopedic, urological, gynecological and many general surgery operations. Although few, side effects of the procedure and its effects on body are well known. However, there is inadequate knowledge about the effects of spinal anesthesia on pressure changes in the eyes. These pressure changes in eyes can result in some detriments. Elevated pressures in the eyes can result in disease known as glaucoma, that makes hazard to eyes. Decreased eye pressures can also result in some eye detriments.

We aimed to investigate the effects of spinal anesthesia procedure on eye (intraocular) pressure changes.

Eligibility Criteria:
Inclusion Criteria:

* patients having general surgery operations under umbilicus
* patients of American Society of Anesthesiologists (ASA) status I-II

Exclusion Criteria:

* patients denying spinal anesthesia
* contraindications for spinal anesthesia
* eye diseases
* hypertension
* ASA status III or more
STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction

This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.

The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated.

All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.


Eligibility Criteria:
Inclusion criteria:

1. Age equal or greater than 18 years
2. Onset of symptoms \< 3 hours prior to randomisation 3.12-lead ECG indicative of an acute STEMI

4.Informed consent received

Exclusion criteria:

Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint
Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?

The investigators evaluate if intravenously applied THC (Cannabis) reduces postoperative Nausea and vomiting. THC will be given during anesthesia before emergence. We measure how long and how effective it reduces PONV


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* elective open and laparoscopic surgery \>1hour

Exclusion Criteria:

* ambulatory surgery
* pregnancy, breast feeding
* \>ASA III
* BMI \>35
* antipsychotic, antiemetic, cytostatic therapy
* major cardiovascular, renal, hepatic, central nervous system disease
* current chronic cannabis consumption and hard drug abuse
* schizophrenia
* preoperative nausea and vomiting, vestibular disease
* not speaking german or french
* refusal to participate
The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children

The goal of this is a randomized controlled intervention study. The study was carried out to determine the effect of nebulization treatment applied to 3-6-year-old children with a soundproof, music player and figured mask nebulizer on the child's anxiety during the procedure. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine.

This is a randomized controlled intervention study. The research was carried out in Kütahya Health Sciences University Evliya Çelebi Training and Research Hospital Paediatrics Emergency Service between 1st May 2022 and 1st June 2022. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine. In order to collect data, Descriptive Information Form, State Trait Anxiety Inventory for Parents, Child Fear Scale and Child Emotional Indicators Scale were used. The data obtained in the study were evaluated with the IBM SPSS Statistics 24 (Statistical Package for Social Sciences) package program.

Eligibility Criteria:
Inclusion Criteria:

* the child should be between the ages of 3-6,
* will receive inhaler treatment,
* the mother or father should be with the child during the procedure,
* not have used any sedative drugs in the last 8 hours before the application,
* written consent has been obtained from the parents after the procedure,
* the child is not crying before the start

Exclusion Criteria:

* the child is younger than 3 years old, older than 6 years oldu,
* the childe has a mental disability,
* communication with the parent havinh a problem (they cannot understand and speak Turkish, etc.),
* the child has pain,
* the child is the terminal period,
* the parent has a situation that prevents the assessment of the scale (mental disability, etc.)
Optic Nerve Sheath Diameter in Laparoscopic Surgeries During Trendelenburg Position

It is difficult to measure the several levels of intracranial pressure during abdominal surgery, and direct monitoring with intracranial devices is often impossible. Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative method for evaluating intracranial pressure. Increased intracranial pressure may cause in expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method to evaluate intracranial pressure.

The peritoneum is inflated with carbon dioxide (insufflation) and head-down position is performed (Trendelenburg) during laparoscopic colon and gynecologic surgeries. Intracranial pressure (ICP) may be affected by positive intraabdominal pressure due to pneumoperitoneum. The Trendelenburg position (usually at a degree of 25-400) causes increasing in the pressure of cerebrospinal fluid during surgery. Therefore, cerebral edema and an increasing in ICP may occur. It is difficult to measure the several levels of intracranial pressure during abdominal surgery, and direct monitoring with intracranial devices is often impossible. Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative method for evaluating intracranial pressure. The optic nerve is an extension of the central nervous system, surrounded by cerebrospinal fluid (CSF) and continues with the nerve sheath. Increased intracranial pressure may cause in expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method to evaluate intracranial pressure.

In this study, we aimed to evaluate the changes of optic nerve sheath diameter in patients who will undergo laparoscopic colon and gynecologic surgery during trendelenburg position. Our primary goal is to compare the optic nerve sheath diameters via ultrasonography, and our secondary aim is to evaluate the effect of this change on intracranial pressure.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Scheduled for laparoscopic colon and gynecologic surgeries under general anesthesia

Exclusion Criteria:

* use of beta blocker or diuretic drugs
* severe heart failure
* diabetes with ocular or neurologic complications
* history of cardiac, eye, intracranial, and thoracic surgery
* history of hydrocephalus, glocoma, intracranial tumor, cerebrovascular disease
Feasibility of a Life Coping Program: a Study Protocol

The goal of this observational study is to evaluate the feasibility of the intervention Life Coping Program in children and adolescents 8-16 years of age. The main question it aims to answer is:

Is the Life Coping Program in its current form feasible among children and adolescents with a variety of primary conditions?

The health care providers of participants already undergoing the Life Coping Program will answer survey questions after key procedures of the intervention, and the research team will be given access to measures provided by the participants.

Feasibility and acceptability of the intervention Life Coping Program will be evaluated in an uncontrolled open-label trial using quantitative measures. Sixty children or adolescents with chronic illness or severe medical condition will be recruited along with one associated caregiver. Feasibility will be assessed by tracking attendance and participation in different parts of the intervention. Acceptability of the intervention will be assessed using patient reported experience measures (PREM). Health related quality of life (HrQoL) and level of physical activity will be measured using the Kidscreen 27 and Actigraph GT3X+ monitor, respectively, at baseline and post-intervention.

The study is based on the British Medical Research Council's (MRC) framework for developing and evaluating complex interventions, and will explore innovative treatment strategies that could potentially improve current clinical outcomes and reduce the need for ongoing healthcare follow-up. The findings from this feasibility study will lay the groundwork for a future definitive randomized controlled trial in accordance with the MRC framework for developing and evaluating complex interventions.

Eligibility Criteria:
Inclusion Criteria:

* Have received treatment at Haukeland University Hospital
* One or more of the following primary conditions: congenital heart defects, congenital oral clefts, premature birth before 32 weeks of gestation, completion of cancer treatment, chronic pain conditions, or significant burn injuries
* Must be able to answer questionnaires in Norwegian

Exclusion Criteria:

* Medical condition that may hinder og alter participation
* Treatment plan that may hinder or alter participation
Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia

In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.

In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* After informed consent, signed the participation form (volunteered for the study)
* Cesarean section
* Spinal anesthesia

Exclusion Criteria:

* Prior neuraxial analgesia (epidural or spinal) for attempted labour
Virtual Peer-to-Peer (VP2P) Support Mentoring for Chronic Pain: A Pilot RCT

Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes and quality of life in adolescents with chronic pain.

The aim of this project is to develop and examine the impact of a virtual peer support program on health outcomes and quality of life of adolescents with chronic pain using a waitlist randomized controlled trial. In addition to standard medical care, adolescents in the experimental group will receive a manualized peer mentorship program that will provide modeling and reinforcement by trained young adults aged 16-25 years who have learned to function successfully with their pain. Mentoring sessions consist of 10 sessions of 30-45 minute Skype calls over 8 weeks. Feasibility of the program will be measured in addition to quality of life, physical and emotional symptoms, pain coping, self-efficacy, social support, and self-management skills.

Eligibility Criteria:
Inclusion Criteria:

* males and females 12-18 years old
* diagnosed chronic pain condition (e.g., neuropathic pain, Complex Regional Pain Syndrome, chronic musculoskeletal pain, chronic daily headache, chronic widespread pain)
* able to speak and read English
* access to Internet connection, computer capable of using free Skype software
* willing and able to complete online measures.

Exclusion Criteria:

* significant cognitive impairments
* major co-morbid illnesses (i.e., psychiatric conditions) likely to influence HRQL assessment
* participating in peer support or self-management interventions (e.g., WebMap).
Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC)

As the most common type of primary liver cancer, hepatocellular carcinoma (HCC) has become a big challenge all over the world. Most patients are not available to curative resection when first diagnosed. There are a variety of treatment options for advanced HCC. However, due to the heterogeneity of HCC, the overall response rate (ORR) is not high for systemic therapies. Therefore, appropriate selection of patients who are suitable for individual systemic therapies is important for clinical decision-making.

Although major achievements have been acquired in diagnosis and treatment, the prognosis of hepatocellular carcinoma (HCC) is still unsatisfactory. Liver resection remains the main curative treatment for HCC, but most patients are at an advanced stage when first diagnosed, leading to be not available to curative therapies. There is a variety of treatment options for advanced HCC, such as transarterial chemoembolization (TACE), hepatic artery infusion chemotherapy (HAIC), targeted therapy (sorafenib and lenvatinib), immunotherapy, and the combination of different therapies. However, due to the heterogeneity of HCC, different patients respond differently to systemic therapies. The the overall response rate (ORR) is not satisfactory and most patients can not benefit from the systemic therapies. There is an urgent need to identify patients who are likely to have positive response to systemic therapies at the beginning before treatment. Therefore ,we want to collect the clinical information of patients with advanced HCC treated with systemic therapies, including demographic data , laboratory index, histological features, radiomics data. Patients are followed-up at a interval of 1 month after treatment, and the ORR, overall survival (OS), progression-free survival (PFS) are recorded. Then the treatment response are evaluated and the relationship between the clinical data and efficacy of systemic therapies are explored by machine learning methods. Then models based on clinical features or radiomics features are developed to predict response to different systemic therapies.

Eligibility Criteria:
Inclusion Criteria:

* clinically or pathologically diagnosed HCC
* Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2
* Child-Pugh score of ≤7
* complete clinical and follow-up information
* evaluable efficacy after treatment
* age between 18-80 years old

Exclusion Criteria:

* with other malignancies
* Eastern Cooperative Oncology Group performance status (ECOG-PS) \>2
* Child-Pugh score of \>7
* incomplete clinical data
* lost to follow up
* unevaluable efficacy after treatment
* age \<18 years old or \>80 years old
Monitoring of Anesthetic Depth and EEG Band Power Using PLE (Phase Lag Entropy) During Propofol Anesthesia

The evaluation of the anesthetic depth monitoring using PLE (Phase Lag Entropy) during propofol anesthesia

The devices using EEG are commonly used for measuring the depth of consciousness during anesthesia. However, the existing devices are largely dependent on the biphasic analysis of 1-channel EEG signals, and thus do not provide proper information for anesthetic depth.

Recent study reported that the complexity or diversity of communication between the brain regions is related to the level of consciousness. In particular, during anesthesia, the phase synchronization (phase shift) between EEG signals at the front of the brain increases, indicating a reduction in communication diversity and a close relationship with loss of consciousness. Therefore, to predict the depth of sleep, a technique for precisely quantifying the complexity of inter-domain communication in the frontal brain is needed. Recently, PLEM™ (Inbody co., ltd, Republic of Korea), developed using the phase lag entropy (PLE), is a 4-channel EEG monitoring device that measures the entropy of the phase difference pattern between two channels of prefrontal and frontal brain. In addition, PLEM™ is able to observe changes in band power of EEG (Gamma, Beta, Alpha, Theta, and Delta waves). As the depth of anesthesia increases, the amplitude and frequency of EEG decreases. Generally, Beta waves (13-30 Hz) are seen in awake conscious patients and Alpha waves (8-12 Hz) are seen in patients resting with eyes closed. And Theta waves (4-7 Hz) and Delta waves (0-3 Hz) can be present in a patient who is sleeping or anesthetized.

The purpose of this study was to evaluate the efficacy for anesthetic depth monitoring of PLEM™ monitor during propofol anesthesia. The primary outcome of this study was to investigate the changes of PLE value and band power of EEG (Gamma, Beta, Alpha, Theta, Delta waves) on the PLEM™ monitor while varying the depth of anesthesia using propofol target controlled infusion (TCI) during anesthetic induction. The secondary outcomes of this study were to investigate whether the muscle relaxant affects the PLE value, and to compare the PLE values with BIS (bispectral index) (Aspect medical system, USA) that was the most widely used to measure the depth of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* The patients undergoing elective general anesthesia with American Society fo Anesthesiologist (ASA) physical status I or II (20-60 years)

Exclusion Criteria:

* Patients with difficulty airway
* Patients with cardiovascular disease
* Patients with cerebrovascular disease
* Patients with respiratory disease