cyrilzakka/clinical-trials huggingface dataset:
Assessment of DOT Spectacles in Chinese Children

This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.


Eligibility Criteria:
Inclusion Criteria:

1. Children 6-13 years of age
2. SER error between -0.75D and -5.00D
3. Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear

Exclusion Criteria:

1. Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K)
2. Astigmatism worse than -1.50 DC (by manifest refraction) in either eye
3. Anisometropia (SER manifest refraction) greater than 1.00 D
A Survey of Management of Analgesia, Sedation and Delirium in ICU Patients in China

In 2018, the severe medicine branch of the Chinese Medical Association and the American Society of severe medicine successively updated the pain and sedation guidelines for severe patients (PADIS guidelines). In addition to the update of the original evaluation and management of pain and sedation and delirium, the new guidelines also increased the monitoring and management of early activities and sleep quality for severe patients. Therefore, it is necessary for us to investigate the compliance of the new guidelines for analgesia, sedation and delirium management among the medical staff of critical care, so as to find out the existing problems in the management of analgesia, sedation and delirium in critical care patients, and find solutions to improve the overall quality level of our management of critical care patients

The first part is to master the current situation of analgesia, sedation and delirium management of ICU patients in China. In order to understand the compliance of Chinese ICU doctors and nurses with the PADIS guidelines, a questionnaire survey was conducted with the participation of multiple centers in China, aiming at the doctors and nurses with different seniority in the critical medicine department. At the same time, the total number of critically ill patients, pain, agitation and delirium assessment tools and critical patients in 2018 were investigated The incidence of pain, agitation and delirium, the implementation of early activities, the monitoring and evaluation of sleep quality, and related interventions, including real-world clinical data such as drug treatment and non drug treatment.The second part focuses on the management of severe delirium in ICU in China. For the patients with delirium in the above survey, a further in-depth and detailed survey shall be conducted, covering the basic diseases of the patients, the occurrence time of delirium, the type of delirium, relevant risk factors, the diagnosis method of delirium, the duration of delirium, the prevention and treatment measures (including drug treatment and non drug treatment measures), and the prognosis of delirium patients .

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old;
* stay in ICU for more than 24 hours and have used analgesics and Sedatives.

Exclusion Criteria:

* Before entering the ICU, they had mental illness and dementia;
* coma or deep sedation could not be evaluated;
* brain injury, stroke sequelae, epilepsy and other brain diseases;
* nerious audio-visual dysfunction and unable to communicate normally.
* Pregnant and lactating women
Proper Fractional Flow Reserve Criteria for Intermediate Lesions in the Era of Drug-eluting Stent

Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow reserve-guided deferral strategy for these lesions showed the same event rate as routine intervention strategy. However, proper FFR criterion for these lesions in the era of drug-eluting stent is not known. This study sought to evaluate the clinical outcomes of intermediate lesions according to FFR and compare those of FFR-guided intervention with routine drug-eluting stent implantation strategy.


Eligibility Criteria:
Inclusion Criteria:

* Elective PCI
* Angiographically intermediate stenosis (50-75% by visual estimation) in native major coronary arteries, proximal and mid (branch, distal lesion: exclusion)
* Reference diameter \> 2.5mm, lesion length \< 60mm (cover by 2 stents)
* No documented evidence of ischemia by noninvasive tests

Exclusion Criteria:

* Acute ST elevation MI
* Left main disease
* Chronic renal failure (cr \>2 mg/dL)
* Expected survival \< 2yrs
* \> 1degree AV block
Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients

Research indicates that many people who are being treated for glaucoma have dry eyes. The purpose of this study is to test the use of artificial tears to alleviate dryness signs and symptoms in people who are using medication to treat glaucoma. The study hypothesis is that the use of artificial tears will result in an improvement in clinical signs and symptoms associated with dry eyes.


Eligibility Criteria:
Inclusion Criteria:

* At least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is a current non-contact lens wearer.
* Has previously been diagnosed with primary open angle glaucoma and is currently being treated with a topical therapeutic agent.
* The glaucoma medication dosage and usage must have been the same for \>6 months.
* Shows a minimum score of 2 (sometimes) on the SESOD questionnaire.
* Distance VA of at least 20/40 in each eye with current spectacle correction.

Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Has any known active\* ocular disease and/or infection; except primary open angle glaucoma.
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications (with the exception of glaucoma medication) that in the opinion of the investigator may affect a study outcome variable;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Is pregnant, lactating or planning a pregnancy at the time of enrolment;
* Has undergone refractive error surgery;
* Is an employee of the Centre for Contact Lens Research;
* Has taken part in another (pharmaceutical) research study within the last 30 days;
* Is currently using artificial tears more than 3 times per day.

  * For the purposes of this study, active ocular disease is defined as infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Comparison of the Effects of Aerobic Exercise and Connective Tissue Massage in Postpartum Women

The aim of this study is to compare the effects of aerobic exercise and connective tissue massage on sleep, mother-infant attachment and psychological state in postpartum women.

Postpartum period can affect the mental and physical health of women. Women may experience sleep problems and psychological problems due to hormonal changes and newborn care responsibilities. As a result, mother-infant attachment may also be affected. Physical activity and exercise should be encouraged in the postpartum period. It is known that aerobic exercises have positive effects on sleep and psychological problems. With the effects of connective tissue massage on the autonomic and circulatory system in the body, positive effects on sleep and psychological state can be achieved, but there are insufficient studies on this subject. In addition, no study has been found to the best of our knowledge comparing the effects of aerobic exercise and connective tissue massage in postpartum women.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum 6th week-1 year
* Between the ages of 18-45
* Being literate

Exclusion Criteria:

* Those with orthopedic, neurological, rheumatological, mental or any systemic chronic diseases
* Those with cardiac problems that may interfere with exercise
* Those with suspected pregnancy
* Those with malignancy
* Those who have infection
* Those who do not regularly participate in the treatment program
Examining How Heart Disease Risk Factors Affect Healthy Aging (The Chicago Healthy Aging Study [CHAS])

Heart disease is the leading cause of death in the United States and is responsible for 30% of all deaths in the United States. This study will examine how risk factors for heart disease in young and middle aged people affect people's health as they grow older.

Heart disease, including coronary heart disease (CHD) and cardiovascular disease (CVD), is a serious health problem in the United States. It is the leading cause of death in this country, and each year almost 700,000 people die from the disease. Risk factors for heart disease include high blood pressure, high cholesterol levels, tobacco use, diabetes, and history of a prior heart attack. It has been shown that young and middle aged adults with few risk factors experience a lower incidence of heart disease, lower Medicare costs, and longer lives than those with more risk factors. However, it is not known how having a low risk for heart disease at a young age affects health-related outcomes in older age. It may be possible that a low risk for developing heart disease in younger years results in healthier aging than does a higher risk. This study will examine former participants of the Chicago Heart Association (CHA) study who are now 65 to 84 years old. The purpose of this study is to determine how risk factors for heart disease in young adulthood and middle age are related to healthy aging.

This study will enroll 1500 people who participated in the CHA study from 1967 to 1973 and who are still living in the Greater Chicagoland area. Six hundred former participants who had a low risk of developing heart disease and 900 former participants who had a high risk of developing heart disease will be enrolled. Participants will attend one study visit that will include medical history interviews and questionnaires, a physical examination, blood pressure measurements, blood and urine collection, and an electrocardiogram (ECG) to measure the electrical activity of the heart. Blood samples will be collected and stored for future genetic testing. Participants will undergo physical functioning performance tests on balance, leg strength and coordination, grip strength, and endurance. They will also undergo a computed tomography chest scan to measure the amount of calcium in the arteries of the heart and ultrasound scans of the arteries in the neck to measure artery size and function.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the CHA study
* Lives in the Greater Chicagoland area

Exclusion Criteria:

* Severely ill, disabled, or cognitively impaired
Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500)

This observational PMCF study will be conducted to generate and gather clinical data from the intended target population of pediatric patients.

The intention for Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of a device throughout the device's lifecycle.

PulmoVista 500 is a lung function monitor for clinical use which continuously generates cross-sectional images of the lung function by applying the technique of electrical impedance tomography (EIT).


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric male or female patients excluding preterm infants
2. Patients with a chest circumference between 36 and 72 cm
3. Patients ≤ 12 years.
4. Patients with a tidal volume \> 20 ml, i.e., children with a body weight of more than 3.3 kg (assuming a targeted tidal volume of 6 mL/kg body weight)
5. Patients for whom mechanical ventilation is intended
6. Patients whose regional distribution of ventilation and of lung volume are of clinical interest
7. Patients who are (should be) ventilated via an artificial airway access, whereby the ventilator used is compatible with PulmoVista 500
8. Patients and / or their legal guardians or legal representatives who have given written informed consent to participate in the study

Exclusion Criteria:

1. Patients who are supplied with a permanent or temporary pacemaker, an implantable defibrillator or other medical devices that emit electrical energy (e.g. cochlea amplifier implant)
2. Patients with a tidal volume ≤ 20 ml
3. Patients in whom the application of the electrode belt could be impaired by wound care or infections in the chest area
4. Female patients for whom pregnancy cannot be excluded; a pregnancy test should be performed at the discretion of the investigator.
5. Patients with an alleged allergic reaction to the materials of the electrode belt
6. Patients with a Body Mass Index (BMI) \> 40
7. Evidence that suggests that the patient or their legal representative will not comply with the protocol requirements
8. Patients with a proven infectious disease (e.g. SARS-COV-19, MRSA) that requires isolation of the patient
Children Born With Club Feet

Clubfoot is one of the most common birth defects, with a prevalence in Europe estimated between 1 and 4.5 for 1000 live birth.

It is useful to distinguish the forms of isolated clubfoot, and the forms related to others morphological abnormalities (complex clubfoot). For the complex forms, the clubfoot can be integrated in a syndromic association, be the consequence of a serious harm of the central nervous system, be associate to a genetic musculo-skeletal disease or wether be associated to a karyotype abnormality.

In those cases, the prognosis depends more about the associated morphological abnormalities that can be the beginning of a severe disability or incompatible with life or any anomaly of the karyotype that clubfoot itself.

In case of several morphological abnormalities, to propose invasive samples with realization of a karyotype and chromosome analysis with CGH array is a consensual attitude.

What the investigators should recommended to the parents in case of isolated form is less obvious and the question of antenatal investigations can not be answered clearly in the literature. Thus, the management of these patients may vary from one CPDP to another.

This study project will make it possible to analyze the management offered to patients whose fetuses have club feet and to study the results of the various examinations carried out in order to adapt the prenatal counselling and to define the best diagnostic strategy to propose to the future parents.


Eligibility Criteria:
Inclusion criteria:

* Congenital clubfoot uni or bilateral
* Have been treated in the reference center " Institut Saint Pierre, Plavas-les-flots, France "

Exclusion criteria:

- Non confirmed clubfoot after birth
Continuous Glucose Monitoring (CGM) in Long Term Care (LTC) Facilities

To prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (CGM)) among residents of long term care facilities (LTC) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (SNF) or nursing home (NH), on different hypoglycemic medications).

This aim will be achieved by recruiting 300 residents with diabetes in 4 LTC facilities. All participants will undergo masked CGM for 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>64 years with diagnosis of type 1 or type 2 diabetes
* Using glucose-lowering medication or insulin

Exclusion Criteria:

* Currently taking or planning to take hydroxyurea
* Patient or Health care proxy refuses to sign consent form
Effects of Perioperative Transauricular Vagus Nerve Electrical Stimulation on POD, POCD and CPSP

Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) occur in 11-51% of patients after surgery, and its prevalence increases with age. The occurrence of delirium is associated with increased morbidity and mortality, prolonged hospital stay, worse functional recovery. Orthopedic procedures and specifically joint replacements have been considered as a major risk for development of chronic postsurgical pain (CPSP). Approximately 13-44% of patients will develop CPSP after knee or hip arthOpioid abuseroplasty. CPSP may cause the discomfort, distress, disability and opioid abuse. Mounting evidence has revealed that inflammation triggered by surgical trauma plays a key role in POD, POCD and CPSP. Recent studies found that vagus nerve stimulation showed the suppression of inflammation. In this study, the effect of perioperative transauricular vagus nerve stimulation on the prognosis of patients undergoing arthroplasty will be investigated, providing potential solutions for the prevention and treatment of postoperative cognitive dysfunction, postoperative delirium and chronic postsurgical pain.

The investigators assessed POD by the Confusion Assessment Method for the ICU twice daily for 7 days after surgery. Participants' cognitive function was assessed with neuropsychological battery tests. The tests included digit span (forward and backward), Corsi block, paired associate verbal learning, digit symbol test, trail-making test and so on.The investigators make a CPSP diagnosis based on the 11th revision of the International Classification of Diseases.

Eligibility Criteria:
Inclusion Criteria:

* 50 to 80 years old.
* ASA grade I-Ⅲ.
* elective knee or hip replacement.

Exclusion Criteria:

* Mini-Mental State Examination (MMSE) score \< 23.
* Education years\<7.
* Peptic ulcer disease, serious cardiac-cerebral vascular disease.
* Neurological or psychiatric disorders.
* History of drug and alcohol abuse.
* Hepatic and/or kidney dysfunction.
* BMI\>35.
* Patients on antidepressants.
* ASA \>Ⅲ.
Comparison of 30-day Morbidity and Mortality in Cancer Patients Based on Emergency Department Location

Patients being followed for cancer account for 2.8% of emergency admissions in France. An acute episode that triggers a visit to the emergency department may be related to the progression of the disease, or to complications of treatment. The management of these patients is often complex and requires a degree of expertise. Emergency departments specialising in the management of cancer complications have been set up, and now deal exclusively with patients treated at their centres. However, for geographical or logistical reasons, patients with cancer are likely to consult a non-specialist emergency department and/or one located outside the cancer care centre. In this case, the emergency doctor may not have access to the oncology file, and care in the emergency department and downstream services may be sub-optimal. Studies have shown a positive impact on the quality of care and prognosis of patients thanks to the cancer centre's expertise. However, the effect of the centre on a cancer patient who visits the emergency department has never been studied. This is particularly true if the emergency department where the patient is seen is located in the cancer follow-up centre.

The primary objective of the COVER study is to investigate the impact of the location of the emergency department where the patient is seen for their prognosis.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 or over admitted to an emergency department with cancer that has been active or in remission for less than a year.

Exclusion Criteria:

- Opposition to participate in the study
Resistant Starch and Non-starch Polysaccharide (Dietary Fibre) Intake and the Colonic Microbiome in Older People

The development of preventative nutritional strategies to promote healthy ageing is becoming increasingly important. Elevated thresholds for taste and smell, coupled with swallowing difficulties and masticatory dysfunction, often result in nutritionally imbalanced diets among the elderly. This can induce great changes in the composition and metabolic activities of the gut microbiome, leading to decreased intestinal motility and impaired bowel function. This can result in constipation or diarrhoea, increased basal levels of inflammation, immunosenescence and morbidity. The objectives of this study are to use dietary modification to improve gut health in older people. Diets high in resistant starch or dietary fibre will be given to 50 elderly volunteers (70-95 years) living in the community, in a randomised double-blind cross-over study. The aim is to investigate the effects on microbiome composition and functionality through fermentation, reduced putrefaction, and modification of blood markers associated with obesity and diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 70-95 years, with BMI 18.5-30.0 kg m2.

Exclusion Criteria:

* Exclusion criteria will include asplenia and other acquired or congenital immunodeficiencies
* Any autoimmune disease
* Self-reported symptoms of acute or recent infection (including use of antibiotics within the previous 3 months)
* Taking probiotics or prebiotics, including lactulose for constipation
* Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, cancer).
* Specifically, volunteers who are diabetic will not be excluded from the investigation.
* Assessment will be on a case by case basis.
A Study of IBI362 in Chinese Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of IBI362 in Chinese patients with Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (WHO 1999)
2. T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 3 months prior to screening.
3. Have HbA1c of 7.0% to 10.5%, inclusive(detected by local laboratory at screening).
4. Have a body mass index (BMI) between 20(Inclusive) and 40 kilograms per square meter

Exclusion Criteria:

1. Type 1 diabetes, special types of diabetes, or gestational diabetes.
2. Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening.
3. History of severe hypoglycemic episodes within 6 months prior to screening.
4. Have had any of the following within the last 6 months prior to screening: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted),transient ischemic attack (TIA), cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure.