cyrilzakka/clinical-trials huggingface dataset:
Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue

Obstructive sleep apnea (OSA) is a common condition of Down syndrome patients. In pediatric practice, there is no way to determine the children with an increased risk. The aim of the study is to determine the reliability of four questionnaires used in pediatric patients in screening of OSA in Down syndrome children.

Prospective study where patients are evaluated on airway diseases and aeroallergens sensitization with 2 parental surveys (PSQ-SRBD and CSHQ), otolaryngologic problems by completing by the ENT surgeon 2 others surveys (CAS-15 and SCR), and sleep disease with an overnight polysomnography (PSG), in University Hospital in Nice.

Introduction: Children with Down syndrome (DS) commonly have obstructive sleep apnea (OSA) though undervalued by parents and physicians. Several sleep questionnaires are used in paediatric patients to detect high risk children who have OSA, but not really appropriate for DS patients. The aim of the study is to determine the reliability of four questionnaires used in paediatric patients (PSQ-SRBD: Pediatric Sleep Questionnaire-Sleep-Related Breathing Disorder, CSHQ: Children's Sleep Habits Questionnaire, CAS-15: Clinical Assessment Score-15 and SCR: Sleep Clinical Record) in screening of OSA in DS population.

Study design: Prospective study concerning children with Down syndrome (age 1-18y). Parents will complete two sleep symptom questionnaires (PSQ-SRBD and CSHQ) and children will be evaluated by a paediatric pulmonologist and allergist with skin allergy test. An Ear, Nose and Throat specialist will complete two questionnaires (CAS-15 and SCR) carrying a nasopharyngoscopy. Then, children will perform an overnight polysomnography in the Department of Paediatric Functional Investigations of University Hospital in Nice.

Eligibility Criteria:
Inclusion Criteria:

* Age under 18 years
* Down syndrome with cytogenetic diagnosis
* State health cover
* Consent of legal representative and/or patient

Exclusion Criteria:

* Polysomnography with correct results during the 12 months before
Protocol for CAMUS Delphi Study

Multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology.

The CAMUS Delphi Study: A Consensus on Reporting of Complications After Urological Surgeries is a multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology. The initial survey consists of a 12-part questionnaire that will aim to reach consensus on a wide range of contentious issues in Urological surgery using the frameworks of both the established Clavien-Dindo Classification (CDC) and the new CAMUS Classification.

To ensure comprehensive and comparable complication reporting across centres worldwide, a conclusive uniform language for reporting complications must be created and subsequently integrated. Accurate reporting will allow for more precise allocation of resources, improve unit efficiency, and reduce healthcare burden, while providing clinicians with a better understanding of intra- and post-operative morbidity. If a comprehensive, homogenous reporting construct is integrated worldwide, the potential to build and develop a universal database with complications from all centres around the world will surely provide invaluable data to create new guidelines and recommendations, ultimately improving patient counselling and surgical quality of care.

Eligibility Criteria:
Inclusion Criteria:

* Local and international consultant Urologists, accredited Urology trainees, consultant Anaesthetists and consultant ICU specialists will be invited to complete the survey. Critical care physicians who are primarily Urological anaesthetists or have experience in complication reporting will be targeted.

Exclusion Criteria:

* All other specialists that do not meet the inclusion criteria.
* Under 18 years of age.
Assessment of the Disease Severity and Treatment Patterns of Rheumatoid Arthritis in Eastern Europe, Middle East and North African Countries (P08167)

The study will assess the disease severity and treatment patterns of rheumatoid arthritis in Eastern European, Middle Eastern, and North African countries.


Eligibility Criteria:
Inclusion Criteria :

* Confirmed diagnosis of rheumatoid arthritis, preferably based upon criteria established by the American College of Rheumatology (ACR) 1987
* clinical signs \& symptoms
* data obtained from previous laboratory and instrumental examination, which may include but is not limited to: Radiography, Blood tests
* Written informed consent, signed before participation in the study.

Exclusion Criteria :

* Refusal to participate in the study
* Age under 18 years
L1 M1 of LDCT for Low Muscle Mass Measurement

The first lumbar spine muscle index (L1 MI) on computed tomography (CT) obtained by measuring muscle surface at the first lumbar vertebrae (L1) level is an indicator of total skeletal mass in specific populations. Nevertheless, the utility of L1 MI derived from low dose chest CT (LDCT) in health assessments and relevant cutoff points are unclear.


Eligibility Criteria:
Inclusion Criteria:

* Adults older than 20 years who received LDCT in routine health assessments from January to December 2017 were enrolled at a tertiary care hospital (Far Eastern Memorial Hospital, New Taipei City, Taiwan).

Exclusion Criteria:

* nil
The Effect of D-serine as add-on Therapy in Recent-onset Psychosis

In psychotic disorders, negative symptoms and cognitive impairment are difficult to treat with antipsychotics, which are mostly effective for positive symptoms. However, it is important that negative symptoms and cognitive impairment are treated as well, as they both play a large part in the acute episode and long-term course of schizophrenia outcome. Previous studies have used D-serine as add-on treatment in patients with psy-chotic disorders and high-risk patients, with positive results. So far, no study has investigated the effects in a sample of recent-onset psychosis patients.

Therefore, this study will include 30 patients (18-50 years old) with recent-onset psychosis. In addition to their regular treatment, patients will receive either D-serine (2 g/d) or placebo for 6 weeks. D-serine is an amino-acid naturally occurring in the brain which is prescription-free available as nutritional supplement.

The primary outcome measure is total score on the Positive and Negative Syndrome Scale (PANSS). Secondary measure-ments include PANSS subscales, neurocognitive tests, (f)MRI, and EEG


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* Recent onset psychosis (\< 5 years of overt psychotic symptoms)
* Able to read and understand study procedures and participant's information

Exclusion Criteria:

* Clozapine use
* Suicidal ideation
* Psychotic disorders and symptoms associated with general medical conditions or substance abuse
* BMI \> 30
* Renal impairment (history and creatin levels (\< 80 ug/L for woman and \< 97 ug/L for men))
* Hearing impairment
* Current or past (\< 6 months) enrolment in another clinical trial with the primary outcome to improve symptoms
* Pregnant or lactating women (pregnancy test)
Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors

This study aims to investigate the incidence of euphoria induced by remimazolam during gastrointestinal endoscopy and explore its related factors. Gastrointestinal endoscopy, a minimally invasive procedure, often causes discomfort and anxiety for patients. Remimazolam, a short-acting benzodiazepine, is increasingly used for sedation during these procedures due to its rapid onset, short metabolism, and controlled cardiorespiratory effects. This cross-sectional study will evaluate the effect of remimazolam on patient comfort, cooperation, and satisfaction during endoscopy, aiming to optimize sedation protocols and improve clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 65 years, regardless of gender.
* Patients scheduled for routine painless gastrointestinal endoscopy, including gastroscopy, colonoscopy, or both.
* ASA physical status classification: I or II.
* BMI between 18 kg/m² and 28 kg/m².
* Anticipated procedural duration of no more than 30 minutes.
* Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.

Exclusion Criteria:

* History of psychiatric disorders such as schizophrenia, bipolar disorder, or personality disorders, or a history of alcohol, stimulant, or other substance abuse.
* Known allergies or intolerance to any medication used in the study, including remimazolam, sufentanil, or benzodiazepines.
* Patients requiring complex endoscopic procedures (e.g., ERCP, endoscopic submucosal dissection, endoscopic mucosal resection, or peroral endoscopic myotomy).
* History of severe hepatic or renal disease.
* Pregnant or lactating women.
* Participation in another clinical study within the past three months.
* Any condition or factor that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Cognitive Function

This study was the evaluate the efficacy and safety of hydrolysed red ginseng extract on the improvement of Cognitive Function

This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 100 subjects participated in hydrolysed red ginseng extract or placebo group. To evaluate the changes in the evaluation items when hydrolysed red ginseng extract was taken 12 weeks compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Persons who are at least 60 years of age at screening
* Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points
* Persons who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial

Exclusion Criteria:

* Patients with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
* Patients with BMI(Body Mass Index)\<18.5 kg/m\^ or 35 kg/m\^≤BMI(Body Mass Index)
* Patients with alcohol abuse or dependence within the last 3 months
* Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
* Patients with a history of clinically significant hypersensitivity to ginseng or red ginseng
* Patients taking medicines, health functional foods or herbal medicines related to the improvement of cognitive function and memory within 1 month before screening
* Patients who ingested ginseng and red ginseng extract's health functional food within 1 month before screening
* Patients who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
* Patients who participate in another human trial within 3 months
* Those who show the following results in the Laboratory test

  * AST, ALT \> 3 times upper limit of the normal range
  * Other significant laboratory test opinion
* Patients who are deemed unsuitable for participating in the human trial due to other reasons
This is a Prospective Observational Study Assessing the Variation of Impedance Across the Different Tissues to Locate and Block Nerves When Preforming an Axillary Peripheral Nerve Block. the Results Would Enhance Precision of Needle Placement and Increase the Success Rate of the Block.

Impedance can have an impact on nerve block during loco-regional anesthesia, particularly when using techniques such as nerve stimulation or ultrasound guidance to locate and block specific nerves. Impedance refers to the resistance to electrical current flow within tissue, and it can affect the ability to stimulate nerves or visualize them using ultrasound. The aim of this research is to assess the impedance across different tissue type during an axillary peripheral nerve block (skin, fat, fascia, muscle, nerve). The results of this study would help clinicians performing nerve block to enhance the precision of needle placement, thus increase the success rate of nerve block and reduce adverse events such as intraneural or intravascular injections.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years to 90 years old
* No infection at the injection site
* Patient signed the study consent form
* No contraindications for nerve block
* No allergies to any of the drugs used
* Patient able to communicate effectively

Exclusion Criteria:

* Patients not meeting the inclusion criteria
* Patients with bleeding disorders or undergoing anticoagulation therapy
* Pregnant patients
* Patients with mental incapacity
* Any medical conditions posing severe risks during the procedure
A Phase I Study in Healthy Volunteers to Assess Safety of BMS747158

The purpose of this clinical research study is to learn the safety and biodistribution of BMS747158 in normal, healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* age 18-40
* BMI 18-30 kg/m2
* No active or chronic illnesses
* If female: not pregnant, use of birth control or not of child-bearing potential

Exclusion Criteria:

* Significant active or chronic illness
* Any neurological disorder
* GI disease within 3 months
* Recent infection
* Major surgery within 4 weeks
* Donation of blood within 4 weeks
* Blood transfusion within 4 weeks
* Recent history drug/alcohol abuse
* Head trauma
* Significant screening ECG, EEG, lab tests, physical exam and vital signs abnormalities
* Prescription or OTC drugs within 2 weeks
* Exposure to any other investigational drug/device within 6
Adiponectin and Ethnic Differences in Insulin Resistance

The purpose of this protocol is to measure and compare levels of the circulating protein adiponectin and adiponectin's association with insulin sensitivity in Mexican Americans and non-Latino white subjects. The investigators also aimed to examine associations between nutritional factors and adiponectin levels.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age
* BMI 20.0-34.9 m/kg2
* Mexican American with at least 3 grandparents born in Mexico or white with no grandparents of Latino descent.

Exclusion Criteria:

* pregnancy
* breastfeeding
* diabetes mellitus
* blood pressure \> 160/100 mmHg
* creatinine \> 1.5 mg/dl or glomerular filtration rate (GFR) \< 60
* liver function tests \> 3x upper limit of normal (ULN)
* h/o heart failure
* h/o eating disorder
Online Physical Activity and Ergonomics Training in Physiotherapy Students Receiving Distance Education

The pandemic process has caused very important changes and effects in the economy, social life and education practices, especially health at global level. Within the scope of the measures taken, with the closure of educational institutions and interruption of face-to-face education, the education of 1.6 billion students, which corresponds to approximately half of the student population from all educational levels, has been interrupted. The need and approach to open and distance learning has come to the fore with significant changes and effects on education worldwide. Pandemic measures, the transition to distance education and the increase in computer usage caused an increase in ergonomic risks in students. Due to the pandemic process, it has been reported that the physical activity level of students decreases and the sitting period is prolonged. In this study, physiotherapy students who receive distance education will be given online ergonomics and physical activity training and the results will be evaluated.

The pandemic process has caused very important changes and effects in the economy, social life and education practices, especially health at global level. Within the scope of the measures taken, with the closure of educational institutions and interruption of face-to-face education, the education of 1.6 billion students, which corresponds to approximately half of the student population from all educational levels, has been interrupted. The need and approach to open and distance learning has come to the fore with significant changes and effects on education worldwide. Pandemic measures, the transition to distance education and the increase in computer usage caused an increase in ergonomic risks in students. Due to the pandemic process, it has been reported that the physical activity level of students decreases and the sitting period is prolonged. In this study, physiotherapy students who receive distance education will be given online ergonomics and physical activity training and the results will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being receiving distance education due to the Covid pandemic
* Being in the age range of 18-25

Exclusion Criteria:

* Congenital or subsequent disability affecting the musculoskeletal system
* Presence of cognitive impairment
* Having a diagnosed psychiatric disorder
* Having a neurological or cardiovascular disease
* Exercising regularly
Primary Prevention of Sudden Cardiac Death (PREV-DEATH)

The efficacy of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden cardiac death (SCD) is well demonstrated but pivotal studies have been published more than 10 years ago and implantation's conditions tend to change.

The clinical efficacy of implantable cardioverter defibrillator (ICD) as method of primary prevention of sudden cardiac death (SCD) is well demonstrated today. Unfortunately, selection criteria of patients deemed at risk lacks of specificity. For asymptomatic patients with a left ventricular dysfunction (LVEF), current guidelines support implantation of ICD if the LVEF is ≤35%. This target population corresponds to the one studied in the Sudden Cardiac Death in HEart Failure Trial (SCD-HeFT). This trial is 10 years old. The proportion of patients with LVEF \> 30% was low (17%) and the analysis of this subgroup showed no decrease in mortality (hazard ratio = 1.08 \[0.57-2.07\]). That is why the usefulness of ICD in this segment of the population remains a subject of controversy. Moreover, SCD-HeFT did not offer resynchronization therapy despite the fact that more than 40% of patients included had a QRS signal duration ≥120ms.

Conditions for implantation have since changed considerably. The "routine" nature of the implantation procedure and the desire to maximize patient's protection leads us to address for an implantation more easily. As for the resynchronization, it must be attempted in patients with severe heart failure, LVEF ≤35% and QRS sufficiently prolonged.

This suggests that the implanted population is very different nowadays from those from the pivotal studies in terms of mean LVEF and implanted material. However, these two factors are significantly correlated with the risk of SCD... Therefore, the analysis was done on samples of patients who received ICD in primary prevention setting. This study focused on the effect of resynchronization and LVEF at implantation and the subsequent outcome. The results were broadly compared with those of SCD-HeFT.

Eligibility Criteria:
Inclusion Criteria:

* primo-implantation and primary prevention in New York Heart Association (NYHA) II or III chronic heart failure due to ischemic or non ischemic causes and LVEF ≤35%

Exclusion Criteria:

* Cardiomyopathy other than dilated cardiomyopathy such as hypertrophic cardiomyopathy, congenital or valvular heart disease
* Patients with NYHA class I and IV heart failure
An Open Label Study of Gene Therapy Product (Vesemnogene Lantuparvovec) in Spinal Muscular Atrophy

This is an interventional study to evaluate safety and efficacy of AAV-hSMN1 in spinal muscular atrophy patients.

Study duration per participant is approximately 25 months including an approximately 30-day screening/baseline period, an approximately 24-month study observation period including 1 treatment day, and an approximately 24-month follow-up period.

Patients will be tested at baseline and return for follow-up visits twice a week through the first month post dose, and followed by visits at months 2, 3, 6 12, 18 and 24 post infusion. Unscheduled visits may occur if the investigator determines that they are necessary.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SMA based on gene mutation analysis with bi-allelic survival motor neuron (SMN1) mutations (deletion or point mutations).
* Patients or Parent(s)/legal guardian(s) willing and able to complete the informed consent process and comply with study procedures and visit schedule.

Exclusion Criteria:

* Active viral infection (includes HIV or serology positive for hepatitis B or C).
* Use of invasive ventilatory support (tracheotomy with positive pressure) or pulse oximetry \<95% saturation.
* Concomitant illness and any drug that in the opinion of the investigator creates unnecessary risks for gene transfer.
* Clinically significant abnormal laboratory values.
* Participation in a recent SMA treatment clinical trial that in the opinion of the PI creates unnecessary risks for gene transfer.
* Patient with signs of aspiration based on a swallowing test and unwilling to use an alternative method to oral feeding.
Real Time Early Warning Model and Mobile Medical Assistant System for the Impact of Air Pollution on AECOPD Disease

Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.

Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 40 and \< 80 years with post-bronchodilator FEV1/ forced vital capacity (FVC) \< 0.7 and percentage predicted of FEV1\>30%, who were no exacerbation of symptoms in the 6 weeks preceding the study, were included in the study.

Exclusion Criteria:

* Patients who were diagnosed with other chronic respiratory diseases, including bronchial asthma, bronchiectasis and lung abscess.
* Patients with near-terminal illness, congestive heart failure (NYHA III-IV), or cannot record CAT score timely were excluded.