cyrilzakka/clinical-trials huggingface dataset:
Nutritional Study in Spanish Pediatric Population

This study investigates the aspects related to the intake of food and nutrients, physical activity and sedentary behavior of Spanish children from 1 to 9 years. Furthermore, the investigators will know if the consumption of dairy products is associated with a better dietary pattern.

Hypothesis: The habitual consumption of dairy products as part of a regular diet is associated with a better dietary pattern and a higher global diet quality.

A prospective cross-sectional observational study in 1500 Spanish children (1 to 9 years) in urban areas \>50,0000 inhabitants, distributed in eight regions (according to Nielsen Spanish areas) aiming to evaluate the food habits, dietary patterns, and nutrient intake, as well as physical activity behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants between 1 and 9 years old without diseases carrying changes in the dietary patterns.
* Those following dietary advice such as for prevention of non-communicable chronic diseases

Exclusion Criteria:

* Children with any disease that cause changes in the dietary pattern and with any dietary restriction.
* Children suffering a metabolic disease such as hyperthyroidism or hypothyroidism.
* Children diagnosed with allergy and/or food intolerance like dairy allergy, milk allergy, lactose intolerance or cows milk protein allergy.
* Children with any chronic disease that causes changes in the dietary pattern
* Children who live in an institution (colleges, nursing homes, hospitals, host Institutions, etc )
* Children with a transitory pathology (flu, gastroenteritis, chicken pox, etc) at the time of the fieldwork.
* Children following a therapeutic diet due to recent surgery or any other medical prescription.
* Children related to Lactalis or Madison MK employees.
* Children whose parents or caregivers did not provide a signed consent form for their participation or not completed any study phase.
Factors Related to the Progression of Chronic Kidney Disease

Chronic kidney disease is a progressive disorder that has been influenced with many factors. Most of the patients has altered Ca P metabolism and these dis orders are the contributing factors of the disease progression. It has been recently documented that FGF23 and Klotho are the key factors of PTH secretion Ca-P metabolism. This study aimed to evaluate the impact of Klotho and FGF23 on the progression of stage 3-4 chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Non-diabetic chronic kidney disease

Exclusion Criteria:

* Presence of DM
* Actively using calcium based phosphorus binder of vitamin D
Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Currently wearing silicone hydrogel contact lenses on a daily wear basis;
* Currently using OPTI-FREE RepleniSH contact lens solution;
* Generally healthy;
* Normal ocular health;
* Willing to follow study procedures and visit schedule;
* Sign Informed Consent and privacy document;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Use of additional lens cleaners;
* Known sensitivities to any ingredient in either test article;
* Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
* History of ocular surgery/trauma within the last 6 months;
* Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;
* Other protocol-defined exclusion criteria may apply.
Investigation on Burnout of Physicians

This study proposes to analyze the burnout, emotional states, and sleep conditions of internal medicine doctors at the Second Affiliated Hospital of Zhejiang University School of Medicine through a questionnaire survey. The findings aim to provide reference for implementing measures to address burnout among medical staff, improve their physical and mental health, and enhance the quality of healthcare.

Burnout, proposed by American psychologist Herbert Freudenberger in 1974, is defined as a syndrome resulting from chronic exposure to workplace stressors and the inability to successfully manage them. Subsequently, Maslach et al. considered burnout as the state of emotional exhaustion, depersonalization, and reduced personal accomplishment resulting from prolonged exposure to work-related stressors. In January 2022, the World Health Organization (WHO) included "burn-out" in the 11th Revision of the International Classification of Diseases (ICD-11) for the first time, officially recognizing it as a disease. Burnout is considered a syndrome resulting from chronic workplace stress that has not been successfully managed. Compared to other professions, doctors are at a higher risk of experiencing burnout. Burnout among medical professionals is closely related to job quality, doctor-patient relationships, and overall health. In 2022, 47% of 13,000 physicians in the United States reported experiencing burnout. Investigating whether burnout affects physical and mental health, thereby impacting the quality of healthcare, is essential.

Eligibility Criteria:
Inclusion Criteria:

1. Currently employed or non-employed internists, including those in gastroenterology, cardiology, pulmonology, hematology, rheumatology, endocrinology, general medicine, infectious diseases, oncology, neurology, psychiatry, nutrition, and other related specialties.
2. Ability to complete the questionnaire.
3. No history of mental illness.

Exclusion Criteria:

1. Individuals who are not part of the internal medicine system, such as those in surgery, medical technology departments, or administrative roles.
2. Inability to effectively complete all sections of the questionnaire.
The Experiences of Patients Living With Malignant Pleural Effusions

Up to 20 patients with malignant pleural effusions will be interviewed about their experiences of having this condition and its management.


Eligibility Criteria:
Inclusion Criteria:

1. Adults diagnosed with a malignant pleural effusion
2. Has undergone either talc pleurodesis or IPC
3. Have signed a consent form prior to entering the study
4. Life expectancy \> 6 weeks based on LENT guidelines (Low/Moderate risk group) - The LENT score calculation assigns 0 (\<1500 IU/L) or 1 (\>1500 IU/L) for pleural fluid LDH level; 0 to 3 points for matching ECOG performance scores (3 and 4 are combined); 0 (\<9) or 1 (\>9) for neutrophil-to-lymphocyte ratio; and 0 (lowest risk), 1 (moderate risk), or 3 (highest risk) for tumor type.

Exclusion Criteria:

1. Any patient who is unable to understand sufficient English to take part in the semi-structured interviews
2. Weakness or fatigue sufficient so that the patient is unable to take part in the interviews
Clinician Ability to Predict the Presence of Nosocomial Pneumonia Based on Bronchoscopic Findings

This study aims to determine whether interpretations of bronchoscopic results enable physicians to successfully predict the presence of pneumonia in traumatically injured patients.

This study aims to determine whether interpretations of bronchoscopic results enable physicians to successfully predict the presence of pneumonia in traumatically injured patients. Bronchoscopies will be videotaped. The clinician doing the procedure will make prediction as to whether the patient, in fact, has pneumonia. In addition, at least one other physician will view the videotape and predict whether the patient has pneumonia.

Once laboratory results are available, the physician predictions will be compared against the definitive laboratory determination

Eligibility Criteria:
Inclusion Criteria:

* Critical Care staff and fellows of the Departments of Anesthesia and Surgery

Exclusion Criteria:

* Refusal of consent
Isomil Post Marketing Observational Study

The use of soy-isolate protein based formula for infants with cow's milk protein intolerance is common in Indonesia, however, there has not been any systematic collection of clinical data to determine the formula's gastrointestinal tolerance, and the parent's perceptions regarding the formula.


Eligibility Criteria:
Inclusion Criteria:

* infants of 6 - 12 months of age
* full term infants
* birth weight more than 2500 grams
* infants developed symptoms suggestive adverse reactions to cow's milk protein in the investigator's clinical judgements
* subject is prescribed a soy-based infant formula by physician

Exclusion Criteria:

* established/suspected hypersensitivity fo soy
* presence of adverse reactions to cow's milk caused by coincidental infections or other systemic disease
* history of blood group incompatibility, premature delivery, HIV infections, major congenital abnormalities, systemic diseases
* presence of severe gastrointestinal disorder
* subject is participating in any interventional clinical study
Phase I Study on Monoclonal Antibody TB-403 Directed Against PlGF in Patients With Solid Tumours

TB-403 is a monoclonal antibody directed against Placental Growth Factor (PlGF). The antibody binds to PlGF and inhibits the binding to it's receptor, VEGF-1. By preventing this binding, growth of tumor vessels are inhibited and tumor growth prevented.

In this study we are investigating the tolerability and safety of TB-403 in patients with solid tumors who receives multiple intravenous doses of TB-403.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed malignity
* Measurable disease
* Performance status 1 or less (ECOG)

Exclusion Criteria:

* Acute illness or infection
* Concurrent second malignancy
Checklist Based Box System Interventions

Maternal mortality is still high in Ethiopia. Antenatal care (ANC), use of skilled delivery attendants and postnatal care (PNC) services are key maternal health care services that can significantly reduce maternal mortality. However, interventions applied to the continued utilization of these key maternal heath services in a continuum of care approach (i.e. early initiation of ANC and continued utilization up to four plus vists, health facility delivery attended by skilled health care providers and attending three PNC visits) were not well applied and studied.

Hence, the purpose of this study is to test the effectiveness of checklist based box system interventions on improving utilization of maternal health service (Antenatal care, skilled birth attendance and postnatal care) utilization.

Cluster Randomized controlled trial study design will be employed. The sample size for this study was calculated based on the recommendations for sample size calculations for cluster randomized controlled trials with fixed number of clusters, by using STATA. The following assumptions were considered: to detect an increase of postnatal care three utilization from 16% to 28% from previous study, number of clusters available-30, with 95% confidence interval and 80% power, intra-cluster correlation coefficient of 0.04849 from similar studies, 15 clusters per arm. The sample size was calculated to determine number of observations required per cluster, for two-sample comparison of proportions (using normal approximation), Assuming individual randomization, sample size per arm is 194. Then allowing for cluster randomization, average cluster size required is 40, and the final sample size is 1200 pregnant mothers (600 in intervention, and 600 in control). Data analysis will take place in two levels (cluster and individual). Risk ration will be computed at cluster level, and the results of this cluster summary will be compared using t-test. Primary and secondary outcomes will be compared between intervention and control groups with random effects logistic regression models, taking account of clustering.

Eligibility Criteria:
Inclusion Criteria:

* Mothers residing in three of the selected districts Debre-Markos, Gozamin and Machakel districts Mother who are positive for Stanback et al, 1999 pregnancy screening criteria and found HCG positive (confirmed pregnancy) Gestational age of less than 16 weeks Mothers willing to participate in the study

Exclusion Criteria:

* Women who have severe psychological illness, which could interfere with, consent and study participation, Those who have sever clinical complications that need hospitalization Mothers who need special type of ANC follow-up, other than the recommended focused ANC
A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or female subject 40 years of age or older
* Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
* Subject is capable of performing reproducible spirometry maneuvers
* Subject has post-bronchodilator FEV1/FVC ratio \<0.7
* Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
* Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
* Subject has a current or past smoking history of at least 10 pack-years.

Exclusion Criteria:

* Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
* Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
* Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
* Subject has been hospitalized for COPD or pneumonia within 12 weeks
* Subject requires long-term oxygen therapy (\>15 hours a day)
HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs - 1

The purpose of this study is to look at a program for women in drug abuse treatment designed to reduce Human Immunodeficiency Virus/Sexually Transmitted Disease (HIV/STD) risk behaviors and reduce unprotected sexual risk behavior.

The proposed trial is intended to test the effectiveness of a proven, manual driven, five-session safer sexual skills building group (SSB) intervention (Schilling et al., 1991; El Bassel and Schilling, 1992) for female patients in MMTP or in drug-free outpatient treatment. The effects of SSB will be compared to a standard group HIV education session (HE).

This study uses a 2-group, randomized, parallel-group design to compare a five-session safer sexual skills building group to a single 60-min HIV education session (control condition). The control condition is designed to standardize and simulate the usual care at community clinics.

Eligibility Criteria:
Adult females (18 years of age or older) in drug abuse treatment at participating Community Treatment Programs are invited to participate.
Assessment of the Quality of Sleep and Sleep Disorders Among the Professional and Volunteer Firefighters of Loire

Studies have shown that schedules that most disrupt the normal circadian rhythm have the most harmful consequences. Firefighters positive for a sleep disorder have a higher risk of depression and anxiety; they report more traffic accidents, falling asleep during driving, and worth health felt. Furthermore, some studies suggest that sleep disorders are risk factors for cardiovascular disease. This activity is responsible of a worth quality of sleep that could induce a lower effectiveness of emergency response. The consequences of this schedules on sleep and health of French firemen have never been studied.

In this context, the objective of this observational epidemiological study is to evaluate the quality of sleep of the firefighters of Loire.

Eligibility Criteria:
Inclusion Criteria:

* Any professional or voluntary firefighter active in Service Departmental Fire and Rescue of Loire or in retirement, and also the medical and paramedical staff of Service Departmental Fire and Rescue of Loire.
* Any fireman affiliated to a social security regime.
* Any fireman who has received information from the study and has agreed to participate in the study.

Exclusion Criteria:

* Any fireman unable to understand the study.
* Any fireman having a legal protection measure.
Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy

This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA

Objective:

1. To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand
2. To demonstrate physiological and pathological changes in treated patients with Goserelin.
3. To assess tolerability and adverse effect of Goserelin therapy


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Males, age over 20 years, undesired fertility
3. Have positive family history of muscle weakness with these clinical signs:

   * bulbar involvement (difficulty in breathing, swallowing, talking)
   * muscle atrophy with or without fasciculation
   * decrease or normal deep tendon reflex
   * normal Babinski response
   * no sensory impairment
   * mild tremor (either postural or intention)
   * gynecomastia
   * decrease libido and infertility
4. Subjects have a confirmed diagnosis to SBMA by both NCV test and DNA study demonstrated the number of CAG repeated more than 35.

Exclusion Criteria:

1. Have weakness caused by other etiologies and have liver or kidney disease.
2. Have currently prostatic cancer
3. Want to have a child
4. Participation in a clinical study during the last 30 days.
5. Females and children age \< 20 years old
Epidural Injection of Corticosteroids Under USG (EICUS)

Qualitative and quantitatively evaluate the pain control and incidence of adverse effects in patients undergoing corticosteroid infiltration and local anesthetic through sacral epidural puncture with ultrasound assistance or isolated use of fluoroscopy to aid puncture and location of the sacral epidural space. A group will be submitted to epidural corticosteroid infiltration associated with local anesthetic with the use of fluoroscopy for locating the sacral epidural space, which is currently the gold standard for this technique, while in another location group will be held with the use of ultrasound.

Introduction: Procedures guided by ultrasound (USG) have advantages over traditional techniques (fluoroscopy) with respect to regional anesthesia. Some studies have shown its usefulness as a quick, safe and simple tool for the location of the sacral hiatus and to guide the puncture of the sacral epidural space in patients with chronic low back pain, despite the lack of data with respect to clinical outcomes.

OBJECTIVES: Evaluate qualitatively and quantitatively the pain control and incidence of adverse effects in patients undergoing corticosteroid infiltration and local anesthetic through sacral epidural puncture with ultrasound assistance or isolated use of fluoroscopy to aid puncture and location of the sacral epidural space. It will also be evaluated success rate in the first puncture, and the time duration of the procedure in groups.

METHODS: It is clinical, analytical, prospective trial, randomized, covered for evaluators. It will include 30 patients with chronic low back pain or pain in the lower limbs resulting in lumbar canal stenosis, refractory to medical treatment. A group will be submitted to epidural corticosteroid infiltration associated with local anesthetic with the use of fluoroscopy for locating the sacral epidural space, which is currently the gold standard for this technique, while in another location group will be held with the use of ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old;
* Patients who have low back and/or lower extremities due to lumbar spinal stenosis pain outpatients, with regular follow-up refractory to conservative medical treatment (Verbal Scale of Pain \> 3, more three months duration, with no improvement with clinical treatment).

Exclusion Criteria:

* Symptoms that characterize a surgical emergency;
* The presence of sensory or motor deficit (chronic mild motor impairment or mild paresthesia will not be deleted), injury to peripheral nerves, trauma history or recent fracture;
* Serious medical conditions or decompensated;
* Infection at the puncture site;
* Coagulopathy;
* Contrast allergy history or the medications used in the technique;
* Pregnancy.
Long-term Follow up After SG vs RYGB vs OAGB

A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.

A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing Sleeve Gastrectomy, those ones undergoing Roux-en-Y Gastric Bypass and those ones undergoing One-Anastomosis Gastric Bypass. Body Mass Index (BMI), excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity
* age older than 18 years
* Patients willing to participate in the study and giving their written consent

Exclusion Criteria:

* patients undergoing other bariatric techniques than SG, RYGB and OAGB
* Patients undergoing any other surgical procedure added to the bariatric surgery
* patients with medical or surgical pathologies that at the discretion of the investigators do not allow their participation in the study
* inability to understand the nature and purpose of the study and / or to accept written participation in the study
* impossibility to comply with pre-established clinical follow-up.
A Study of Two Formulations of LY3074828 in Healthy Participants

The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given as different formulations. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 12 weeks, not including screening.


Eligibility Criteria:
Inclusion Criteria: Healthy participants.

Exclusion Criteria:

* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
* Must not have been treated with steroids within 1 month of screening, or intend to during the study
* Must not be immunocompromised
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
* Must not have significant allergies to humanised monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years