cyrilzakka/clinical-trials huggingface dataset:
Real Life Pediatric Obstructive Sleep Apnea

OBJECTIVES:

PRIMARY: To analyze the cognitive alterations in children with Obstructive Sleep Apnea OSA in different age groups and changes at 12 months after treatment with a protocol based on usual clinical practice.

DESIGN:

Observational, longitudinal, prospective, and multicenter study.

STUDY POPULATION: Children aged 3 to 12 years consecutively referred to the Sleep Units due to clinical suspicion of OSA.

SAMPLE SIZE: To evaluate the relationship between cognitive measures and polysomnographic variables and differences before-after treatment, a sample size of 1200 children is calculated.

METHODOLOGY: The followiong will be obtained in all children included in the study: personal medical history, Spanish version of Pediatric Sleep Questionnaire (PSQ), physical and otorhinolaryngological examination, neurocognitive assessment by customary neurocognitive and behavioral tests routinely used in Spain (CUMANIN neuropsychological tests, ENFEN neuropsychological tests, and Spanish version of the ECBI (Eyberg Child Behavior Inventory)), sleep study by polysomnography (PSG) or Respiratory Polygraphy (PR) and blood test.

The diagnosis and treatment of OSAS will be established according to the criteria of the Spanish Consensus Document of OSAS in children.

Depending on the treatment, three groups will be obtained: Group 1: Children with OSAS and adenotonsillar hypertrophy we will perform surgical treatment. Group 2: Children with OSAS and without adenotonsillar hypertrophy will be evaluated other treatments (sleep hygiene-diet and physical activity guidance, medical, orthodontic, continuous positive pressure on the airway (CPAP) treatment, Group 3: regular follow up but no treatment for children referred for suspicion of OSAS and that in PSG or RP the diagnosis of OSAS is not established. In all three groups, at 12 months, we will repeat all assessments as delineated for the initial visit

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3 to 12 years consecutively referred to the Sleep Units due to clinical suspicion of OSA.

Exclusion Criteria:

* A significant medical and/or psychiatric comorbidity that may require urgent treatment (Respiratory Failure, Heart Failure, Cardiac Malformations, tumors, psychiatric type disorders that may require specific treatment...)
* Craniofacial malformations, deposit diseases and/or malformation syndromes (including Down's syndrome)
* Already diagnosed neurocognitive type disorders (e.g.: Autism, cerebral palsy, etc.)
* Attention deficit hyperactivity disorders previously diagnosed according to DSM-IV criteria
* Girls ≤ 12 with menarche at the time of starting the study
* Children that refuse to take part in the study (do not sign the Informed Consent
The Effectiveness of Co-packaging With Zinc to Improve Treatment of Diarrhea and Pneumonia in Guatemala

This project applies a randomized community design to test the effectiveness of health center level co-packaging and counseling messages to improve provider and caregiver behavior in the treatment of diarrhea with zinc \& oral rehydration salts (ORS) and treatment of pneumonia with zinc \& antibiotics in children aged 2-59 mo old. We will evaluate the adherence of caregivers in 10 health posts in 5 municipalities randomly assigned to receive the health center level co-packaging and counseling messages in addition to current standard care, by comparing them with the caregivers in 10 health posts in 5 municipalities randomly assigned to the receive only the current standard of care. Cost-effectiveness of co-packaging at the health-center level, as a means of improving provider treatment and counseling practices and caregiver adherence, will be evaluated.

The main objective is to establish the effectiveness of a facility level co-packaging and counseling messages for increasing the adherence by caregivers of children aged 2-59 mo old to the prescribed 10 day treatment with zinc to complement ORS for the treatment of diarrhea and zinc to complement the antibiotics for the treatment of pneumonia diagnosed and treated in public health posts.

Specific Quantitative Objectives:

• To determine if visible co-packaging with pre-tested counseling messages:

* Improves adherence of caregivers of children towards the prescribed zinc treatment.
* Improves knowledge, awareness or attitudes of caregivers of children and health providers at public health care centers towards the prescribed zinc treatment.
* Results in overall increase in health care-seeking for the treatment of diarrhea and pneumonia at public health care centers.

Specific Qualitative Objectives:

* To establish the perception, attitudes and experiences of caregivers towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment.
* To establish the perception, attitudes and experiences of health providers at public health care centers towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment.
* To establish the perception, attitudes and experiences of children aged 4 to 5 years old towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment.

Please note that the study protocol is also available in Spanish.

Eligibility Criteria:
Inclusion Criteria:

* The child is aged between between 2 and 59 mo old (\< 5 years old).
* The child is diagnosed with diarrhea or pneumonia at one of the selected public health care centers.
* The caregiver accompanying the child to the public health care centers must live in the same household.

Exclusion Criteria:

* Unwillingness to sign consent form.
Breast Cancer Education to Prisoner Women

The aim of the study is to determine the effect of breast cancer education given to incarcerated women on breast cancer knowledge and awareness.

Breast cancer is the most common cancer among women in the world, accounting for almost a quarter of cancer cases diagnosed among women, with 1.15 million cases diagnosed each year. Breast cancer is common in both developed and developing countries. However, in developing countries, these rates are three times higher and the mortality rate is quite high. Risk factors include age, low socioeconomic level, early menarche, late menopause, family history of breast disease, long-term use of hormone replacement therapy, breastfeeding status and lifestyle habits.

It is reported that breast cancer screening programs such as mammography, breast self-examination (BSE) and clinical breast examination (CMM) have an important role in early diagnosis, increasing the survival rate, reducing the death rate and preventing relapse in breast cancer patients. It has been reported that women who perform regular BSE are more likely to have early stages of the disease, this is because regular BSE gives the woman information about the feel and appearance of the breast. Thus, the woman will be able to detect any changes as early as possible. It is reported that the practice of breast self-examination depends on different factors, including women's knowledge, attitude, socio-demographic and sociocultural factors. Other reasons for low implementation rates, such as lack of time, forgetfulness, and low education level, have also been reported.

Breast cancer is the second leading cause of death after cervical cancer among incarcerated women under the age of 40. 27% of women over the age of 40 had breast cancer, and 18% of these women died. It is of great importance to raise awareness, which is considered one of the main elements of secondary prevention in breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* Being between the ages of 18-65,
* No history of breast cancer,
* To know Turkish.

Exclusion Criteria:

* Those who do not agree to participate in the study,
* Having a history of breast cancer,
* Those who do not speak Turkish
Open Versus Laparoscopic Dismembered Pyeloplasty Among Adult Patients With Primary Pelvi-Ureteric Junction Obstruction

To prospectively compare the perioperative, morphological and functional outcomes on short and medium term between laparoscopic (LP) and open pyeloplasty (OP) patients.

Pelvi-ureteric junction obstruction (PUJO) is defined as a functionally significant impairment of the flow of urine from the kidney's renal pelvis into the proximal ureter.

Open pyeloplasty (OP) has been the gold standard for PUJO repair since the first successful reconstruction of an obstructed PUJO was accomplished in 1892, and achieves success rates exceeding 90%.

Various open surgical techniques have been described based on the cause, location, and length of the PUJO. The most popular repair is the Anderson-Hynes dismembered pyeloplasty, which has universal application and is accepted as the gold standard of treatment.

Now, Laparoscopic dismembered pyeloplasty represents a minimally invasive alternative of gold standard open Anderson- Hynes technique that has a comparable successful outcome with open pyeloplasty while avoiding its co-morbidities. It is also better than endopylotomy as it deals effectively with the crossing vessel

Eligibility Criteria:
Inclusion Criteria:

All adult patients (above 18 years old) with primary pelvi-ureteric junction obstruction indicated for active intervention as

* Symptoms such as recurrent flank pain, recurrent urinary tract infection and rarely hypertension.
* Breakthrough urinary tract infections while on prophylactic antibiotics.
* Increasing renal antero-posterior diameter, or decreasing renal parenchymal thickness by ultrasound.
* Low or decreasing differential renal function, but above 10%.

Exclusion Criteria:

* Patients having poor ipsilateral renal function \< 10%.
* Patients with previous pelvi-ureteric junction obstruction repair.
* Associated renal stones.
* Patients unfit for surgery according to American Society of Anesthesiologists classification.
* Contraindications for laparoscopy as (marked obesity, large ventral hernias, gross coagulopathy, abdominal wall sepsis, vertebral deformities...).
* Pediatric patients.
* Pregnant women.
* Vesicoureteral reflux.
* Congenital renal anomalies as (horse- shoe kidney, pelvic kidney, mal- rotated kidney ...).
* Single functioning kidney.
* Malignancy.
* Refusal of written consent.
Comparison of IV Fluid Loading and Ondansetron in Reduction of PONV After LC

This study is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor ondansetron or control group (group C).

This study is a prospective randomized control trial. It is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor ondansetron or control group (group C). This study is hypothesized that the incidence of PONV in patients receiving preoperative intravenous fluid loading (group F) and patients receiving ondansetron (group O) will be similarly reduced from the control group (receiving neither fluid nor ondansetron).

Eligibility Criteria:
Inclusion Criteria:

* patients with aged 18 to 70 years with an ASA physical status 1-3

Exclusion Criteria including patients

* with pregnant or breast-feeding patients
* having history of taking antiemetic drugs within 24 hours before surgery
* with hypersensitivity or allergy to ondansetron
* with CKD stage 4, 5
* with congestive heart failure, LVEF \<40
* with cirrhosis child c
* refusal or cannot communicate or understand the purpose of this study
Whole Body Vibration in Chronic Obstructive Pulmonary Disease (COPD) Patients

The whole body vibration offers better treatment adherence among the elderly, minimizing effort and additional stress to the cardiovascular system and skeletal muscles compared to conventional exercise programs.

Hypothesis: Patients with COPD undergoing a training program on the whole body vibration show better performance in the 6MWT and improvement in muscle strength.

In the elderly and in COPD patients weight loss includes sarcopenia, resulting from aging itself or due to disuse or disease states associated with and represents the reduction in muscle mass, leading to decreased strength and endurance, with repercussions on the functional abilities of the same. It reduces the power and muscle strength with aging which represent decreasing to carry out daily physical tasks.

In COPD, exacerbations worsen the loss of muscle mass, affecting the respiratory and peripheral muscles, exercise capacity and survival rates, and in the case of severe malnutrition in advanced cases of the disease, the implications of this state are disability which occur between 10-15% in those with mild obstruction and 25% in moderate to severe obstructive and are associated with worse prognosis.

The whole body vibration could be an efficient combination of training methods for elderly patients and is based on the generation of sinusoidal vibrations offered by a platform, which stimulates the muscle spindles resulting in activation of neurons α engines and develop muscle contractions, presenting itself as an alternative to conventional treatment for muscular endurance as well as improving physical fitness

Eligibility Criteria:
Inclusion Criteria:

* Smoking history, occupational or environmental exposure to pollutants and / or cough, hypersecretion or dyspnea,
* FEV1 \<80% predicted and postbronchodilator FEV1/FVC \<70% to confirm the diagnosis of airway obstruction air not fully reversible bronchodilator therapy,
* Have the ability to perform the walk test, 6 minutes, absence of comorbidities that preclude the achievement of effort (hypertension, severe pulmonary hypertension, myocardial infarction, congestive heart failure, severe dyspnea)
* Preserved cognitive functioning,
* Clinically stable during the study period

Exclusion Criteria:

* Have cognitive impairment, hearing or visual compromise the response to the questionnaires used in this study
* Make modifications to the appliance neuro-musculo-skeletal system that prevents the completion of the 6MWT
* Be participating in physical activity programs.
Phase II Open-Label Pilot Study of V3381 in Chronic Cough

The investigators hypothesise that cough reflex hypersensitivity, demonstrated in chronic cough patients, is due to a phenomenon known as central sensitisation. Central sensitisation is a hyper-excitability of the sensory nerves as they join the central nervous system, and is believed to be mediated by the N-Methyl-D-Aspartate (NMDA) receptor\[1-3\].


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-75 years of age
* Females must be of non child-bearing potential
* Chronic Cough ( \> 8 weeks)
* Normal Chest X-ray
* Normal Lung Function
* Idiopathic or treatment resistant cough-

Exclusion Criteria:

* Recent upper respiratory tract infection (\<4 weeks)
* Pregnancy/breast-feeding
* Current smokers or ex-smokers with \<6 months abstinence or cumulative history of \>10 pack years
* Current treatment with ACE inhibitors.
* Drug or alcohol abuse
* Uncontrolled hypertension (i.e., \>140/90 mmHg despite adequate medical therapy).
* Any cardiovascular condition that would be a contra-indication to the use of sympathomimetic amines (e.g. active angina).
* Any clinically significant neurological disorder
* Prior renal transplant, current renal dialysis.
* Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study.
* Increased risk of seizures.
* Any malignancy in the past 2 years (with the exception of basal cell carcinoma).
* Use of opioids, anticonvulsants, antidepressants (particularly MAO inhibitors).
* Any clinically significant abnormal laboratory test result(s).
* Serum creatinine laboratory value greater than 1.5 x upper limit of normal (ULN) reference range (after adjustment for age) or estimated creatinine clearance \<60 mL/min.
* Total bilirubin greater than upper limit of normal reference range (with the exception of Gilbert's Syndrome) and/or alanine transaminase (ALT) \>1.5 times upper limit of normal reference ranges (after adjustment for age).
RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan

The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI

The objectives on patients still alive one year after the first cycle of nal-IRI :

* Characterize mPDAC patient population according to their demographics
* Identify PDAC treatment by line of treatment from diagnosis to last treatment
* Explore prognostic factors of longer Overall Survival (OS) and Progression Free Survivor (PFS) among mPDAC patients showing long-term Survival

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years (≥ 19 years in South Korea)
* Cytologically confirmed mPDAC at initiation of the nal-IRI treatment
* All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen
* Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021)
* At least one cycle of nal-IRI-containing regimen should have been administered
* A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen)
* Availability of data related to survival outcomes in the patient medical record
* Patients deceased or not at the time of enrollment will be eligible for inclusion in the study

Exclusion Criteria:

* No documentation of systemic therapy outcomes or prior treatments in patient medical records
* Patients with second concomitant metastatic malignancy
Analgesic Effect of Erector Spinae Plane Block After Caesarean Section

Background: Our hypothesis was that bilateral ESP block applied from the transverse process of T9 in women who underwent elective cesarean section with pfannenstiel incision under spinal anesthesia could provide effective postoperative analgesia.The primary outcome in this study was total opioid consumption for 24 hours.

Material and Method: This randomized prospective study was carried out on 50 pregnant women who was scheduled for elective cesarean delivery via a Pfannenstiel incision with spinal anesthesia.Patients were randomly allocated in to two equal groups.Group SA was categorized as the group which spinal anaesthesia alone (SA) was performed, Group SA+ESP was categorized as group which SA+ESP block was performed. All groups received 7 mg isobaric bupivacaine +15 µg fentanyl intrathecally through spinal anesthesia. The SA+ESP group, ESP block was performed at the ninth thoracic transverse process with 20 ml 0.25% bupivacaine + 2 mg dexamethasone immediately after the operation. Total fentanyl consumption in 24 hrs, visual analogue scale (VAS) score for pain, time to the first analgesic request were evaluated postoperatively.


Eligibility Criteria:
Inclusion Criteria:pregnant women,38-42 gestational weeks, ASA I-II

Exclusion Criteria:

* ≤18 or ≥45 age, has emergency obstetric surgery, pregnancy induced hypertension, significantly systematic disease, foetal or placental abnormality, hypersensitivity or allergy history to medicine to be used in the study, BMI≥35, autonomic neuropathy, diabetic, contraindicate to apply neuroachylic anaesthesia, who was transferred to general anaesthesia, could not decide or did not want to participate in the study, had severe respiratory and cardiac disease, was transferred to general anaesthesia, has infection, spine or chest wall deformity in operation area, has opioid dependence, chronic analgesic usage, inability to use a patient-controlled analgesia (PCA) device, couldn't be able to cooperative and express their pain with visual analogue scale score (VAS).
Evaluating the Association Between Pericardial Fat and Coronary Heart Disease - Ancillary to MESA

Coronary heart disease (CHD) is the leading cause of death in the United States. One common risk factor for CHD is obesity. The presence of certain types of fat over others is more commonly associated with the development of CHD. This study will use data from a previous study to examine the association between pericardial fat, a type of fat that surrounds the heart, and CHD.

CHD is caused by a narrowing of the small blood vessels that supply blood and oxygen to the heart. It usually results from atherosclerosis, a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries. Risk factors for CHD include tobacco use, high blood pressure, diabetes, and obesity. Visceral fat, the type of fat found in the abdomen and surrounding vital organs, is considered a greater risk factor for CHD than subcutaneous fat, the type of fat found directly below the skin. Pericardial fat, the fat surrounding the heart, is similar to visceral fat, and may be particularly damaging because of its lipotoxicity effects and its ability to trigger inflammation in the coronary arteries. Increased amounts of pericardial fat may therefore accelerate the development of atherosclerosis and CHD. The purpose of this study is to evaluate the relationship between pericardial fat and the development of CHD.

This study will use previously collected data from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) study, a study that examined characteristics of the subclinical, or the early stages of, cardiovascular disease in individuals. There will be no study visits specifically for this study. Participants' study data and computed tomography (CT) scans will be analyzed to determine the following: 1) the presence of pericardial fat and subclinical CHD at study entry; 2) changes in pericardial fat levels and plaque formation; and 3) the presence of pericardial fat and CHD at a 6-year follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Participant in the MESA study
* Had a baseline and 6-year follow-up CT scan as part of the MESA study

Exclusion Criteria:

* Participant did not have a baseline or 6 year follow-up CT in the MESA study
Effects of Tea Catechin Extracts on Oxidative Damage

The purpose of this study is to clarify the effects of tea catechin extracts on the frequency changes of micronuclei in peripheral lymphocytes compared with other oxidative stress markers in late middle aged healthy volunteers

Experimental studies have revealed that tea catechin extracts induce preventive effects on oxidative stress, but there have been few clinical trials conducted to verify the effects. Also, there have been few clinical markers indicating oxidative damage, and therefore, more accurate and reliable markers have been expected. The study is designed for evaluating the effects of tea catechin extracts on the frequency changes of micronuclei in peripheral lymphocytes as the indicator of oxidative damage, compared with other oxidative stress markers in late middle aged healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* aged 40 to 65 years old
* healthy volunteers
* obtained written informed concent before participation

Exclusion Criteria:

* participant who is not able to refrain from drinking tea for 2 weeks during the study
* participant taking supplements or herbal products including folate, vitamin B, C, E, coenzyme Q10, calcium, for 2 weeks before the study
* participant taking supplements or herbal products including folate, vitamin E for 3 months before the study
* participant possessing tea allergy