cyrilzakka/clinical-trials huggingface dataset:
The ILet Experience Study

A one-year, prospective single-arm cohort study to collect safety and effectiveness data on the iLet Dosing Decision Software during real-world use in people 6 years of age or older with type 1 diabetes (T1D) with 12 months follow-up.

The study will compare outcomes data during iLet use to efficacy and safety outcomes data derived from epidemiological studies, such as data published by the T1D Exchange registry, and to the results of the Bionic Pancreas Pivotal Trial (BPPT), with a special emphasis on serious adverse effects such as severe hypoglycemia and DKA. An analysis will be conducted comparing glycemic outcomes during iLet use to baseline pre-iLet CGM and HbA1c data in participants who have provided this data. In addition, the study will determine the frequency and types of anticipated and unanticipated device issues experienced by users during real-world use.

Eligibility Criteria:
Inclusion Criteria:

* Users must meet the following criteria in order to be enrolled in the study:

  1. Diagnosed with type 1 diabetes and prescribed the iLet Bionic Pancreas System
  2. At least 6 years of age
  3. Using or planning to use either U100 Novolog (insulin aspart) or U100 Humalog (insulin lispro) in ready-to-fill cartridges, or U100 Fiasp® PumpCart® (insulin aspart) in pre-filled 1.6mL cartridges
  4. Willing to provide HbA1c results obtained within the 6-month period prior to starting use of the iLet and during the last 6-months of study participation
  5. Willing to provide CGM data, if available, obtained in the 1-month period prior to starting use of the iLet
  6. For females, not pregnant or planning pregnancy in the next 12 months
  7. Able to respond to alerts and alarms, and to provide basic diabetes self-management
  8. Reside full-time in the US
  9. Able to speak and read English
  10. Willing and able to download the iLet Mobile App and keep it active throughout the study and upload device data regularly
  11. Willing to answer baseline survey, monthly surveys, and share CGM data, and follow-up data, as necessary

Exclusion Criteria:

* Users with the following characteristics will not be considered candidates for the study:

  1. Type 2 diabetes, cystic fibrosis-related diabetes, congenital hyperinsulinism, pancreatogenic diabetes, or any form of diabetes mellitus other than type 1 diabetes
  2. Use or planned use of any insulin in the iLet other than U100 Novolog (insulin aspart) or U100 Humalog (insulin lispro) in ready-to-fill cartridges, or U100 Fiasp® PumpCart® (insulin aspart) in pre-filled 1.6mL cartridges
  3. End-stage renal disease on renal replacement therapy (peritoneal dialysis or hemodialysis)
  4. Use or planned use of hydroxyurea
The Significance of Remnant Cholesterol and Carotid Intima Media Thickness in Patients With MAFLD

1. To detect the significance of remenant cholesterol in detection severity of MAFLD
2. To detect the significance of carotid intima-media thickness in MAFLD

Non-alcoholic fatty liver disease (NAFLD) is fatty infiltration of the liver in the absence of other causes of steatosis, such as alcohol consumption characterized by excessive fat accumulation in liver \>5-10% of its weight encompassing a spectrum of increasingly severe clinico-pathological conditions - nonalcoholic fatty liver (NAFL) and nonalcoholic steato-hepatitis (NASH) with or without fibrosis/cirrhosis. Since NAFLD is frequently associated with further metabolic comorbidities such as obesity, type 2 diabetes mellitus, or dyslipidemia, it is generally considered as the hepatic manifestation of the metabolic syndrome A growing body of evidence also indicates that NAFLD is strongly associated with an increased risk of major CVD events and other cardiac complications (ie, cardiomyopathy, cardiac valvular calcification and cardiac arrhythmias), independently of traditional cardiovascular risk factors NAFLD has also been associated with an increase in the carotid intima- media thickness (CIMT), independent of conventional CVD risk factors. CIMT is a marker of early atherosclerosis and has been shown to predict increased risks of myocardial in-farction and stroke Fatty liver index (FLI) has been proposed as an accurate, convenient, and economic surrogate of the severity of NAFLD. Remnant cholesterol refers to the cholesterol content carried by triglyceride-rich lipoproteins, which include non-LDL-C and nonhigh density lipoprotein-cholesterol (HDL-C) A large number of studies have reported that serum remnant cholesterol levels were positively associated with the risk of coronary artery disease NAFLD

, type 2 diabetes , and metabolic syndrome

Eligibility Criteria:
Inclusion Criteria:

* The study will include adult patients (≥18 years) presented to fibroscan clinic and diagnosed as MAFLD.

Exclusion Criteria:

1. Patients Known previous cardiac disease ( cardiovascular disease, heart failure, arrhythmia )
2. Patients Known liver cirrhosis
3. septic patients
4. Patients have malignancy
Point-of-Care Bedside Lung Ultrasound Examination Advanced Trial Protocol

The purpose of this study was to evaluate the availability and diagnostic accuracy of point-of-care bedside lung ultrasound examination in management of mechanical ventilation in neonatal acute respiratory distress syndrome.

Neonatal acute respiratory distress syndrome (ARDS) is a critical condition requiring dynamic evaluation and interventions. Point-of-care bedside lung ultrasound examination (PoC-BLUE) is a noninvasive, readily available imaging modality that can complement physical and clinical evaluation.

At any time, most neonates and infants with ARDS in medical intensive care units (ICUs) require mechanical ventilation, making it one of the most frequently used critical care technologies. However, difficulties with regard to the accurate diagnosis of ARDS before administration of mechanical ventilation, dynamic monitoring of treatment effects during administration of mechanical ventilation, and decision-making of timing in weaning from mechanical ventilation, are often encountered in the majority neonates and infants who require mechanical ventilation.

Hence, techniques that expedite and advance the knowledge of the administration of mechanical ventilation should have an important clinical significance in the diagnosis, treatment and prognosis of ARDS.

Preliminary researches have suggested that BLUE has a high diagnostic accuracy in patients with acute respiratory failure, and has the potential to quantify the rate and degree of diaphragm thinning during mechanical ventilation, which may be useful to predict extubation success or failure during either spontaneous breathing (SB) or pressure support (PS) trials.

Unfortunately, few studies focus on the availability of PoC-BLUE in management of mechanical ventilation in neonatal acute respiratory distress syndrome. Also, they call into question the possible association of the demographic and clinical confounders with the diagnostic accuracy of PoC-BLUE for diagnosis, monitoring and prognosis of ARDS in the whole process of mechanical ventilation.

Given that a considerable need for a timely and dynamic diagnosis of severe condition and therapy evaluation during mechanical ventilation has been triggered to integrate the currently available bulk of knowledge and information, the objective of this study is to investigate the availability and diagnostic accuracy of PoC-BLUE Plus protocol in management of mechanical ventilation in ARDS.

Eligibility Criteria:
Inclusion Criteria:

* All infants who present to the ICU with respiratory symptoms suspicious for ARDS, according to Pediatric Acute Respiratory Distress Syndrome: Consensus Recommendations From the Pediatric Acute Lung Injury Consensus Conference, which is proposed by The Pediatric Acute Lung Injury Consensus Conference Group.
* In whom the treating Collaborative Review Groups of Poc-BLUE-Plus protocol believe would benefit from diagnostic imaging.

Exclusion Criteria:

* Infants who arrive at the ICU with a previously performed chest radiography
* Unstable infants with life-threatening injuries who require ongoing resuscitation
REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma

Phase 1:

* To confirm the safety and anticipated recommended phase 2 dose (RP2D) of REGN2810 (cemiplimab) for children with recurrent or refractory solid or Central Nervous System (CNS) tumors
* To characterize the pharmacokinetics (PK) of REGN2810 given in children with recurrent or refractory solid or CNS tumors

Phase 2 (Efficacy Phase):

* To confirm the safety and anticipated RP2D of REGN2810 to be given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG)
* To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed high-grade glioma (HGG)
* To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with re-irradiation in patients with recurrent HGG
* To assess PK of REGN2810 in pediatric patients with newly diagnosed DIPG, newly diagnosed HGG, or recurrent HGG when given in combination with radiation
* To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at 12 months (OS12) among patients with newly diagnosed DIPG
* To assess anti-tumor activity of REGN2810 in combination with radiation in improving progression-free survival at 12 months (PFS12) among patients with newly diagnosed HGG
* To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at OS12 among patients with recurrent HGG


Eligibility Criteria:
Key Inclusion Criteria:

1. Age 0 to \<18 years of age (Phase 1)
2. Age ≥3 and ≤25 years of age (Efficacy Phase)
3. Karnofsky performance status ≥50 (patients \>16 years) or Lansky performance status ≥50 (patients ≤ 16 years)
4. Life expectancy \>8 weeks
5. Adequate Bone Marrow Function
6. Adequate Renal Function
7. Adequate Liver Function
8. Adequate Neurologic Function

Key Exclusion Criteria:

1. Patients with bulky metastatic disease of the CNS causing Uncal herniation or symptomatic midline shift, significant, symptomatic mass effect, or uncontrolled neurological symptoms such as seizures or altered mental status
2. Patients with metastatic spine disease and gliomatosis as documented by diffuse involvement of \>2 lobes
3. Patients who are receiving any other investigational anticancer agent(s)
4. Patients on greater than dexamethasone 0.1 mg/kg/day (maximum 4 mg/day) or equivalent dose in alternate corticosteroid, or actively undergoing corticosteroid dose escalation in the last 7 days
5. Patients with a history of allogeneic stem cell transplant
6. Prior treatment with an agent that blocks the PD-1/PD-L1/PD-L2 pathway

Note: Other protocol-defined Inclusion/Exclusion criteria apply
The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis

This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.

The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.

The decision to discontinue the trial is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Serum albumin as specified in protocol
* Malnourished (based on serum albumin value below 40 g/L, assessed centrally)
* Stable (for 3 months or more) and adequate haemodialysis treatment three months prior to enrolment as defined by Kt/V of more than 1.2

Exclusion Criteria:

* Active malignant disease
* Critical illness requiring treatment in an intensive care unit (ICU)
* Uncontrolled treated/untreated hypertension
* Patients on chronic (more than 3 months) treatment with steroids in doses of more than 10 mg/day prednisolone (or equivalent)
* Patients treated with immunosuppressive agents
* Known Growth Hormone Deficiency
* Patients suffering from any clinically significant disease history in the opinion of the investigator
* Severe illness as defined in the protocol (as judged by the investigator)
Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children with Hematoplastic Disease

The investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs in children with hematoplastic disease.

The investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs based on the opportunistic sampling strategy in children with confirmed or suspected hematological neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be diagnosed with hematological neoplasms
* Antineoplastic drugs or anti-infective drugs used as part of regular treatment

Exclusion Criteria:

* expected survival time less than the treatment cycle;
* patients with other factors that researcher considers unsuitable for inclusion.
Implementation Study of the ICOPE Program for the Detection of Frailty in the Elderly Within the Territorial Health Professional Communities (CPTS) of Brest Region

Frailty is a geriatric syndrome resulting from a decrease in physiological reserve capacities altering the mechanisms of adaptation to stress with, in the absence of diagnosis and management, a short-term risk of falls, hospitalization, loss of autonomy and death.

In 2019, the World Health Organization has taken up this subject with the objective of reducing the number of dependent people in the world by 15 million, i.e. 150,000 in France. For this purpose, recommendations for integrated care for seniors (Integrated Care for Older People = ICOPE) have been published.

6 functions are essential to maintain autonomy: mobility, memory, sight, hearing, mental health and nutrition. The first step of the ICOPE program consists of screening for a decline in one of these functions using a tool made up of questions or tests that can be carried out in 8 to 10 minutes in primary care by trained non-professionals. The second step is a thorough evaluation of the person screened, leading to the creation of a personalized care plan. In the current state of affairs, despite its recommendations, this identification is not carried out in Brittany.

The objective of this study is to demonstrate the feasibility of implementing the first stage of the ICOPE program by seizing the opportunity of the creation in the Brest region of two Territorial Health Professional Communities (CPTS) : Brest Santé Océane and Iroise santé.


Eligibility Criteria:
Inclusion Criteria:

* Primary care staff belonging to one of the 2 CPTS (CPTS Brest Santé Océane and CPTS Iroise santé) and having accepted to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
The Correlation Between Health Status and Self-Assessment of Health Condition, and the Relation to Health Services Utilization

This study aims to examine the relation between health status and self-assessment of health condition, their relation to healthcare services utilization, and also to identify the profile of those who assess their health condition as mediocre to poor in general population and according to nationality.

Background:

The World Health Organization defines "health" as a state of physical, mental and social well-being of an individual, and not just the absence of disease or illness. Health self-assessment is almost never present in medical and clinical models, which define "health" as the absence of physical disease. On the one hand, some say that there is a correlation between these definitions, and others argue that self-assessment of health is not always consistent with the clinical health status evaluation. Few studies have examined the relationship between self-assessment and health status among residents of the State of Israel in general and among the population residing in the Galilee and Western Galilee area in particular. The studies presented contradictory findings about the health perception among Jewish and Arab population. There are about 600,000 residents in Western Galilee from various population sectors, including Jews, Arabs, Druze and others. This composition of population pretty much reflects the general composition of population in the Galilee area.

Study objective:

This study aims to examine the relation between health status and self-assessment of health condition, their relation to healthcare services utilization, and also to identify the profile of those who assess their health condition as mediocre to poor in general population and according to nationality.

Methods:

A cross-sectional study was conducted among 250 visitors aged 18 and above of outpatient clinics in the Galilee Medical Center (former Western Galilee Hospital): opthalmology, dental, otolaryngology (ENT) and orthopedic. The target population group for this study is adult residents of the Western Galilee area. The sampling is random. For the aims of the survey five sampling days were selected in each of the four outpatient clinics. On each of the sampling days all visitors of different outpatient clinics were offered to complete a self-administered structured questionnaire adapted specifically for the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult residents of the Western Galilee area

Exclusion Criteria:

* Non literate visitors
Self-administered TDCS for Improving Single- and Dual-task Gait in Patients with PD

The purpose of this study is to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait in patients with Parkinson's disease.

Parkinson's disease (PD) is a disease caused by dopamine deficiency in the striatum resulting from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive neurodegenerative disease characterized by motor symptoms including gait disturbance and balance instability. In the early stages of Parkinson's disease, dysfunction of the sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles. Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and the automaticity of walking is reduced. Dual-task performance involves a complex interplay of motor functions as well as cognitive functions such as attention and executive function. One way to potentially reduce the cost of dual-tasking and the negative effects of motor-cognitive interference is to consider improving the corresponding component, i.e., motor or cognitive function.

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that can be used to change cortical activity. Recently, there has been growing attention on tDCS as an adjunct tool for rehabilitation. Several tDCS studies in patients with PD have reported the positive results of tDCS on motor and cognitive function. Most studies have examined changes before and after a single session of stimulation, with limited research verifying the cumulative and long-term effects of tDCS. Therefore, this study aims to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait in patients with PD.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as idiopathic Parkinson's disease by neurologists according to the UK Parkinson's Disease Society Brain Bank criteria
* modified Hoehn \& Yahr stage 2, 2.5, or 3

Exclusion Criteria:

* History of seizure
* Metallic implants, such as cardiac pacemaker or an artificial cochlea
* Patients with inflammation, burns, or wounds in the stimulation area
* Parkinson's disease dementia; cut-off is \< 7 of Korean-Montreal Cognitive Assessment for illiterate patients, \< 13 for those educated for 0.5-3 years, \< 16 for 4-6 years of education, \< 19 for 7-9 years of education, and \< 20 for 10 or more years of education.
* Severe dyskinesia or severe on-off phenomenon
* Plan to adjust medication at the time of screening
* Other neurological, orthopedic, or cardiovascular co-morbidities significantly affecting gait function
* Uncontrolled vestibular disease, orthopedic hypotension, or paroxysmal vertigo
* Pregnant or lactating patients
* Other comorbidities that make it difficult to participate in this study
Epigenetics Modifications in Obstructive Sleep Apnea

Changes in epigenetic regulation of genes involved in systemic inflammation and metabolic dysfunction in OSA are linked with accelerated cardiovascular morbidity.

Design. EPIOSA is a 5-yr non-interventional longitudinal prospective study being conducted at the Sleep Clinic of the Hospital Miguel Servet, a large teaching hospital in Zaragoza (Spain). Following a baseline visit, subjects are to be followed-up at 3 months, and then every year.

Subject participation. The investigators will enroll a total 300 consecutive OSA male patients aged 20-60 yrs, with baseline apnea-hypopnea index ≥ 5 events per hour of sleep (AHI). In addition, 50 control subjects (AHI \< 5) aged 20-60 yrs and matched by body mass index (BMI) are also to be recruited. Exclusion criteria will include any comorbid condition including alcohol and tobacco use.

Measurements: Routine clinical assessment, full sleep study, bilateral carotid ultrasonography, biochemistry, circulating inflammatory cytokines, T cell subsets and epigenetics studies at baseline and every year until at least 5 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 60

Exclusion Criteria:

* Any comorbid condition