cyrilzakka/clinical-trials huggingface dataset:
Exploring the Effects of Sleep Patterns and Physical Activity on Asthma in Adolescents With Wrist-worn Smart Devices

This is a research study to find associations between asthma symptoms and sleep patterns and physical activity among adolescent patients with persistent asthma. The Investigators will collect Fitbit® sensor data and survey data from each adolescent enrolled in the study.

Investigators from the University of Arkansas for Medical Sciences (Pediatrics), the University of Arkansas at Little Rock and the University of Florida will work together to conduct a research study to find associations between asthma symptoms, sleep patterns, and physical activity over an 8-week period among adolescent patients with persistent asthma.

The goal of this research study is to find new ways for teenagers to manage their asthma. Full understanding of the connection and interference of sleep patterns and physical activity with asthma symptoms will be very helpful for teenagers with asthma to better manage their daily routine and asthma care. This research study will use wrist-worn devices (i.e. Fitbit® wristbands) to collect participants' sleep and physical activity data.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 14 and ≤ 17 years;
2. Teen access to a mobile smartphone device with a data plan or a computer with reliable internet connection, compatible with the Fitbit® application during the study period;
3. Diagnosis of mild, moderate or severe persistent asthma per National Heart Lung Blood Institute (NHLBI).

Exclusion Criteria:

1. Current smokers and adolescents with significant underlying respiratory disease other than asthma (such as cystic fibrosis) that could potentially interfere with asthma-related outcome measures;
2. Prior diagnosis of sleep disorder;
3. Patients with significant co-morbid conditions (such as moderate to severe developmental delay) that could interfere with the adolescent's ability to self-monitor asthma;
4. Inability to speak or understand English (child or parent).
Comparison of Manual Skills, Visual-Motor Integration and Participation of Children With and Without Type 1 Diabetes

The aim of this study is to compare visual-motor integration, academic achievement and participation in activities of daily living with and without type 1 diabetes.

There are two different groups in this study. The first group includes children with type 1 diabetes and the second group includes healthy children. Children aged 8-12 years were included in the evaluation. Beery-Buktenica Developmental Test of Visual Motor Integration , academic achievement (Turkish, mathematics, social sciences exam scores) Participation and Environment Measure-Children an Youth, Jebsen Taylor Hand Function Test were used for evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Being between the ages of 8 and 12,
2. To be diagnosed with Type 1 diabetes,
3. To be receiving education at primary education level,
4. Children who agree to participate in the cooperative during the evaluations,
5. Parents and children accepted to participate in the study.

Exclusion Criteria:

1. Any acute or chronic illness that affects the level of physical activity,
2. Other types of diabetes,
3. Mental problems,
4. Having received psychiatric treatment,
5. Having vision problems.
Pediatric Behavioral Informatics to Prevent Cancer

The goal of this study is to do formative research which will lead ultimately to the development of a computer-based system called Tailored Information for Diet and Exercise or TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in children. The system will be used by physicians and parents/primary care givers in pediatric primary care practices with the aim of improving parent-pediatrician interactions related to counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of the child in the waiting room and assesses topic areas related to energy balance behaviors (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey administration.


Eligibility Criteria:
Inclusion Criteria:

* primary care givers or legal guardians of children 4-10 years of age who has attended the last two well-child visits with their child

Exclusion Criteria:

* parent cares for a child who is on a special diet prescribed by pediatrician
Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

The researchers are investigating if changing an individual's behaviors may have an impact on outcomes for patients with pulmonary arterial hypertension (PAH). This research will test the efficacy of a home-based exercise program to improve exercise tolerance and physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of group 1 Pulmonary Atrial Hypertension (PAH) diagnosed during right heart catheterization (RHC) according to WHO criteria 28
* WHO functional class II to III
* Stable clinical condition, with no change in medical therapy for pulmonary arterial hypertension (PAH) for at least 3 months before enrollment
* Planned follow-up at University of Michigan Hospital Centers over at least 1 year
* If enrolled in clinical trial, must be in open-label extension stage on stable medications for at least 3 months.
* Competent to give informed consent
* Have computer and internet access

Exclusion Criteria:

* Life expectancy under 1 year
* Co-morbidities which limit physical activity to a severe degree (i.e., permanently wheelchair bound, musculoskeletal disorders, recent myocardial infarction, unstable arrhythmia)
* Current substance abuse, and/or a severe psychiatric disorder (including severe depression, psychosis, or dementia) which limits the patient's ability to follow the study protocol
* Recently completed (\<6 months), current enrollment or planned enrollment in pulmonary rehab.
* ≥30 minutes of exercise, ≥ 1 day per week for the previous 3 months
* Six-minute walk distance \<150 meters or \>550 meters
* Moderate or severe obstructive lung disease forced expiratory volume/forced vital capacity (FEV1/FVC) \< 70% and FEV1 \< 65% of predicted value after bronchodilator administration).
* Moderate or severe restrictive lung disease (total lung capacity \< 60% predicted value).
* Arterial oxygen saturation (SpO2) \<88% during 6-minute walk test on baseline home oxygen prescription if applicable or SpO2 \<80% if uncorrected shunt.
* History of exercise-induced syncope or arrhythmias.
* Pregnancy or lactation
* Non-English speaking
ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation

To compare the number of patients with AF recurrence detected in a 24-h Holter monitoring with a 5-day record.


Eligibility Criteria:
Inclusion Criteria:

* Have undergone an AF ablation procedure at the Hospital Clínic and have a 12-month follow-up planned.
* Having been previously assessed by the AF nurse.
* Having signed the informed consent.

Exclusion Criteria:

* Extreme skin fragility at chest level
* Allergy to latex or adhesive tape
* No electrophysiology follow-up at the Clínic hospital.
* Patients who are already included in other studies that may interfere with the expected results of this one.
* Patients with cognitive impairment or disorientation.
The Safety and Efficacy of SYD-101 in Children With Myopia

Myopia, or nearsightedness, is the most common eye disorder, often affecting more than 40% of adults in Europe, Asia and the USA. Severe myopia is associated with an increased risk of developing other eye conditions such as glucoma, cataracts and retinal detachment, which may lead to blindness. Early treatment of myopia in children could help slow the condition and minimize the risk of complications later in life. This study investigates the use of SYD-101, an eye solution, in slowing-down the progression of myopia in children.

This will be a 5-arm, multicentered, randomized, double-masked, vehicle-controlled study conducted in 2 parts.

Part 1 is the primary treatment period of 3 years, during which participants will receive 1 of 3 masked medications.

Part 2 is the randomized withdrawal period of 1 year, during which participants originally receiving Vehicle will receive SYD-101, and participants originally receiving SYD-101 will receive either Vehicle or SYD-101.

Eligibility Criteria:
Inclusion Criteria:

* Myopia of 0.5 D (diopters) to 6.00 D (inclusive) in both eyes.
* Astigmatism ≤1.50 D in both eyes.
* Anisometropia ≤1.00 D in both eyes.
* If myopia is ≥0.75 D, participant must be wearing single vision eyeglasses or soft, daily-wear, single-vision contact lenses that meet study investigator's criteria.
* BCVA (best-corrected visual acuity) Snellen equivalent of 20/32 or better.

Exclusion Criteria:

* Participants with a history or current evidence of a medical condition predisposing them to degenerative myopia (e.g. Marfan syndrome, Stickler syndrome), or a condition that may affect visual function or development (e.g. diabetes mellitus, chromosome anomaly).
* Current use of a monoamine oxidase inhibitor.
* Evidence of any ocular inflammation or infection in either eye, including blepharitis, conjunctivitis, keratitis, and scleritis.
* Past, present or future plans to use orthokeratology (orthoK), rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression; or the use of atropine, pirenzepine or other anti-muscarinic agent for myopia.
* History or evidence of ocular surgery or planned future ocular surgery in either eye.

Other protocol-defined inclusion/exclusion criteria could apply.
Using AR Dental Care Training on Periodontal Status, Blood Sugar Control and QoL in Patients With Type 2 Diabetes

The aim of this study was to evaluate the long-term effectiveness of an AR dental care training in health education on periodontal status, blood sugar control and quality of life in patients with poorly controlled type 2 diabetes. This randomized controlled trial included experimental group: AR group (EG-AR), AR health consulting group (EG-ARHC) and control group (CG), respectively. The EG-AR and EG-ARHC received AR dental care training intervention 2 to 3 times during non-surgical periodontal treatment. Baseline and follow-up surveys were used to collect the data in periodontal index, blood sugar data, oral health knowledge, attitudes, behavior, oral health related quality of life.

A randomized experimental design was used. Patients with type 2 diabetes whose aged 35-65 years and HbA1c over 7% in the past six months were recruited through department of Endocrinology and Metabolism in Chimei Hospital Yongkang and Liuying Campus.

Each group was expected for 100 per group, patients will be randomized into each group. G\*Power (version 3.1.9.4) was used for power analysis. All patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month and 1-year follow-ups. Each patients will be diagnosed periodontal disease by dentist and have more than 12 functional teeth. Each patients will completed the questionnaire at baseline and at 1-month, 3- month, 6-month and 1-year follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Age 35 years old (inclusive) and above
* HbA1c over 7% in the past six months
* There are more than 12 functional teeth to ensure that the patient has enough teeth to evaluate the periodontal condition

Exclusion Criteria:

* Have received periodontal treatment within the previous 6 months
* Habits of smoking, drugs and betel nut chewing
* Taking antibiotics and osteoporosis bisphosphonates and other drugs regularly
* People with cognitive function or physical and mental disabilities
* Severely impaired diseases (for example: cancer, renal function or liver failure, etc.)
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Prolonged Surgery

The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after prolonged surgery.

The investigators identify all patients undergoing prolonged surgery which the operation time \>3 h, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.

60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients Undergoing Prolonged Surgery

Exclusion Criteria:

* Patients with incomplete electronic medical record information
FLIO and the Influence of Oral Lutein Supplementation on Macular Pigment

To investigate the effects of lutein supplementation on macular pigment density using FLIO and MPOD measurements in patients with age-related macular degeneration and healthy subjects over a course of 6 months.

The human macula is a small area of the retina responsible for central vision. The yellow macular pigment contains three carotenoids, lutein ((3R,3'R,6'R)-lutein), zeaxanthin ((3R,3'R)-zeaxanthin), and meso-zeaxanthin ((3R,3'S;meso)-zeaxanthin). The human body is unable to synthesize lutein and zeaxanthin, thus needs to be obtained from dietary sources such as green leafy vegetables and supplements. The function of the macular pigment is to act as a filter by absorbing blue light that may attenuate photochemical damage of the retina. Furthermore, it protects against light induced oxidative damage by functioning as an antioxidant; scavenging free radicals. A growing body of evidence has established a link between the concentrations of the macular pigment carotenoids, the macular pigment optical density (MPOD) levels, visual performance and the risk of macular degeneration.

The ability of the macular pigment to absorb or filter blue light can be measured as macular pigment optical density (MPOD), which is directly related to the quantity of lutein and zeaxanthin in the macula. Furthermore, preliminary data showed that macular pigment can be evaluated using Fluorescence lifetime imaging ophthalmoscopy (FLIO). In a previous study the investigators have shown that FLIO provides contrast for macular pigment in patients with AMD and healthy subjects.

The purpose of this study is to investigate the effects of oral lutein supplementation on macular pigment density using FLIO and MPOD measurements in healthy subjects and patients with age-related macular degeneration (AMD) over a course of 6 months. Furthermore, the investigators will assess whether compositional and functional alterations of the gut metagenome may be related to age-related macular degeneration, and the effects of lutein supplementation on the gut. In addition, to blood samples, stool samples will be analysed accordingly to the currently running study on "The role of the gut metagenome on the development of ophthalmic diseases" ClinicalTrials.gov Identifier: NCT02438111. Faecal analyses will provide insight to how oral lutein supplementation effects the gut microbiota and how it is influenced by serum lutein Levels.

Objective is to investigate the effects of lutein supplementation on macular pigment density using FLIO and MPOD measurements in patients with age-related macular degeneration and healthy subjects over a course of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be willing to give written informed consent
* Probands 18 years of age or greater
* Both eyes will be assessed in the study

Exclusion Criteria:

* Opacities of ocular media excluding detailed observation of the retina
* Gastrointestinal diseases that could cause disturbance of dietary absorption
* History of lutein supplementation
* Allergy to lutein and zeaxanthin
* Missing compliance
Epigenetics and NCD Prevention in Kazakhstan: Personalized Approaches and Biological Age Prediction

This study aims to enhance personalized and preventive care for non-communicable diseases (NCDs) in Kazakhstan by examining epigenetic factors, predicting biological age and reproductive function using machine learning, and developing health improvement recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 69 years.
* Residents of 17 regions of Kazakhstan.
* Willingness to participate and provide informed consent.

Exclusion Criteria:

* Age less than 18 years old or over 69 years old.
* Failure to provide informed consent or incomplete participation in data collection procedures.
Characteristics of Signal Intensity Gradient in Subarachnoid Hemorrhage After Aneurysmal Rupture

10-20% of patients with subarachnoid hemorrhage die before they arrive at the hospital, and about 25% die within 24 hours. About 1% of patients are diagnosed with cerebral aneurysms in imaging tests for health checkups, and many of them experience aneurysmal rupture during their lifetime, so it is not a rare disease. Wall shear stress is known to be a factor that reflects the state of blood vessels, and particularly plays an important role in the patency of the intima of blood vessels. In the meantime, computed fluid dynamics (CFD), a representative method for calculating wall shear stress, assumes a virtual rigid pipe and applies a preset value. This does not accurately reflect the physiological and dynamic state of the actual blood vessel. The investigators intend to measure the patient's wall shear stress using the SIG of the MRA-TOF technique, which reflects the physiological characteristics of individual patients, and to analyze the association with rupture of the intracranial aneurysm.


Eligibility Criteria:
\<Ruptured group\>

Inclusion Criteria:

1) Patients over 18 years of age who visited our hospital for acute subarachnoid hemorrhage due to rupture of a intracranial aneurysm (2) Among patients satisfying (1), who had intracranial magnetic resonance imaging (time-of-flight (TOF) technique applied; diffusion-weighted imaging, including apparent diffusion coefficient) before subarachnoid hemorrhage occurred.

Exclusion Criteria:

1. Patients under the age of 18
2. Patients with subarachnoid hemorrhage due to causes other than rupture of intracranial aneurysm
3. Patients with poor imaging quality due to artifacts caused by patient movement during brain magnetic resonance imaging examination

\<Unruptured group\>

Inclusion Criteria:

1. Magnetic resonance imaging performed during the screening period (Time-of-Flight (TOF) technique is applied to intracranial vessel imaging; It also includes diffusion-weighted imaging and apparent diffusion coefficient)
2. Patients diagnosed with unruptured intracranial aneurysm in the final reading of brain MR test
3. Patients who remain without aneurysmal rupture on follow-up intracranial magnetic resonance imaging

Exclusion Criteria:

1. Patients under the age of 18
2. Patients with poor imaging quality due to artifacts caused by patient movement during brain magnetic resonance imaging examination
Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC

In this monocentric randomized controlled trial, 120 potential non small cell lung cancer (NSCLC) patients for which tissue diagnosis and material for next generation sequencing (NGS) is required for clinical management will be approached the day of their endobronchial ultrasound to participate in the study. They will be randomized to 2 vs 3 passes/lymph node and will all undergo liquid biopsy. The co-primary outcomes are 1)the rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node and 2)the percentage of patients for which liquid biopsy allows to identify clinically pertinent findings not available from tissue biopsy


Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed NSCLC requiring tissue sample for NGS testing to guide clinical management
* Presence of at least 2 targets accessible by EBUS or EUS suspicious of malignancy (primary tumor, lymph node \> 10mm or with Standardized Uptake Value (SUV) \> 2.5)

Exclusion Criteria:

* Other modality then EBUS judged preferable by treating physician to obtain tumoral tissue for NGS testing
Hemo Filtration Reinfusion (HFR) Clearance Efficiency Towards P-bound Toxins and Effects on Inflammatory and Endothelial Damage Markers

The aim of this study is to compare purification efficiency of HFR in terms of clearance of protein-bound toxins and the effects on markers of inflammation and endothelial damage, in comparison to HF-HD and OL-HDF.

Protein-bound uremic toxins are poorly removed by current dialysis techniques because of their size, which is larger than the pore size of dialysis membranes available in the market. These protein-bound uremic toxins have emerged as important risk factors for progression of CKD, as well as for cardiovascular disease. Several studies have demonstrated that protein-bound uremic toxins induce vascular inflammation, endothelial dysfunction and vascular calcification.

In dialysis patients, serum concentrations of p-cresyl sulphate and indoxyl sulphate are approximately 17 and 54 times higher, respectively, than in healthy subjects. Because these toxins are bound to proteins, only a 30% or less is removed efficiently by hemodialysis. Traditional renal replacement therapies depend upon diffusion and convection for solute clearances and the use of an adsorbent in combination with dialysis membranes may be a new therapeutic option to increase removal rate of these uremic protein-bound toxins.

HFR technique uses a dual dialyzer with a resin between chambers. The first chamber is a high-flux membrane where convective process takes place. The ultrafiltrate obtained from this first chamber passes through the cartridge and is reinfused before the second chamber, a low-flux membrane, where diffusive process is performed.

In HFR, adsorption and haemodiafiltration are attached, using ultrafiltrate as a replacement fluid and being capable of theoretically removing most medium and high molecular weight uremic toxins. A potential benefit has been regarded for toxicity, biocompatibility, tolerance, and preservation of essential elements such as albumin, vitamins, amino acids or growth factors. An improvement on oxidative stress has also been described in HFR.

Eligibility Criteria:
Inclusion Criteria:

* Stable patients on hemodialysis for al least 3 month
* older than 18 year old
* dialyzed at least for two months with a high-flux membrane permeability
* arteriovenous fistula with high blood flow (\> 350 ml / min)

Exclusion Criteria:

* active neoplasia
* positive viral markers (HBsAg, anti-HCV and HIV),
* clinical signs of active infection and/or inflammation,
* albumin \< 3.5 g/dl.