cyrilzakka/clinical-trials huggingface dataset:
Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients

To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.

The goals of this proposal are to implement a Close-Loop/Artificial Pancreas (CL/AP) system in older patients with type 1 diabetes mellitus (T1DM) in order to reverse brain metabolic adaptations and restore metabolic sensitivity, hypoglycemia awareness and appropriate hormonal counterregulatory responses (CRR). For purposes of this study we are looking to enroll aged T1DM subjects under insulin pump treatment.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Male or female
* Age 50-75 years (at least 50% over the age of 65)
* T1DM (\>20 years duration)
* C-peptide undetectable
* HbA1c of \< 8%
* Insulin pump therapy
* History of frequent hypoglycemia with unawareness (defined as 2 or more episodes of severe hypoglycemia within one year requiring assistance) and 2 or more glucose values \< 54 mg/dL during the week of Continuous Glucose Monitoring (CGM) (iPRO monitor, Medtronic) prior to enrollment
* BMI \<27 kg/m2
* Good general health as evidenced by medical history and blood screening
* Willing to comply with all study procedures and be available for the duration of the study
* Willing to fast for a limited time period on the morning of a clamp study

Exclusion Criteria:

* Significant diabetic complications (untreated proliferative retinopathy, creatinine ≥1.5 mg/dl, urinary albumin levels 300 mg/day, autonomic neuropathy, painful peripheral neuropathy)
* Significant alcohol intake and vegetarian diet since both are known to have an impact on counterregulation and brain metabolism
* Any contraindications for MRI scanning, including presence of metallic implants or claustrophobia.
* Heavy exercise on a regular basis (i.e. marathon runners)
* Known allergic reactions to components of the study product(s)
* Treatment with another investigational drug or other intervention
* Active infection including hepatitis C, hepatitis B, HIV
* Any past or current history of alcohol or substance abuse
* Psychiatric or neurological disorders under active treatment
* Baseline hemoglobin \< 10.5 g/dL in females, or \< 12.5 g/dL in males. Blood donation within 30 days of the study
* History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
* Co-existing cardiac, liver, and kidney disease
* Abnormal liver function tests
* Women that are on oral contraceptives, post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.
* Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
Comparison of Using CIBPB With or Without IV-PCA After Arthroscopic Rotator Cuff Repair

The goal of this study is to compare the continuous brachial plexus block with or without intravenous patient controlled analgesia(PCA) in patients undergoing arthroscopic rotator cuff repair, in terms of quality of recovery, postoperative pain score, and adverse event.

The Bellomic® M silicone balloon infuser, dual continuous petite type (cebika, Uiwang-si, Gyeonggi-do, Republic of Korea) has 2-channel infusion elastomeric pump with two balloon chambers.

This structure allows the simultaneous use of continuous nerve block and intravenous PCA. In addition, intravenous PCA can be continued even when continuous nerve block is discontinued due to discomfort such as numbness, tingling sense or motor block.

This is expected to contribute to the patient satisfaction and quality of recovery.

Eligibility Criteria:
Inclusion Criteria:

* Having arthroscopic rotator cuff repair
* American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

* Contraindication to interscalene brachial plexus block
* Contraindication to fentanyl
Treatment Effects From Aerobic Endurance Training and Maximal Strength Training in Patients Suffering From Schizophrenia

This study investigates treatment effects from aerobic endurance training, maximal strength training and computer game on aerobic capacity, work efficiency and psychiatric symptoms in patients suffering from schizophrenia. The study is a controlled trial. The aim is to describe the population in respect to aerobic capacity and muscular strength. Low aerobic capacity and muscular strength are important risk factors for cardiovascular disease (CVD). The study also aim to evaluate physical and psychiatric effects from physical training. Effects from participation in physical training or computer game on symptoms, depression and quality of life will be investigated. Data will be collected between October 2005 and August 2007.


Eligibility Criteria:
Inclusion criteria: schizophrenia, schizotypal and delusional disorders (F20-F29) according to the international statistical classification of diseases and related health problems, 10th revision (ICD-10) prepared by the World Health Organization. Patients must have stable antipsychotic medication for six weeks prior to participation.

Exclusion criteria: coronary artery disease, chronic obstructive pulmonary disease, not being able to perform physical treadmill testing and exercise, and less than 80% compliance to the training sessions. All subjects go through a physical health examination at inclusion.
The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance

This observational study will test and evaluate the RestEaze ambulatory sleep monitor for the detection and classification of leg movements during sleep (LMS) and other sleep measures.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 5 -75
* General good health and ambulatory
* Sleep complaint or other diagnosis that affects sleep (e.g. ADHD) with likely concomitant abnormal LMS requiring either HST or PSG
* Reports no significant problems sleeping in a new bed and bedroom away from home
* (If applicable) Parent or guardian available to spend the night with the child during the sleep study

Exclusion Criteria:

• Amputation that would preclude use of wrist actigraph or the RestEaze device
Assessment of Salbutamol Effect on Arterial Oxygenation in COPD Patients During One-lung Ventilation

One-lung ventilation (OLV) is essential part of anesthesia during thoracic procedures. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung, which may result in severe hypoxemia. Although the protective mechanisms of hypoxic pulmonary vasoconstriction favorably modulate pulmonary perfusion to the ventilated lung, the effect is attenuated in patients with history of chronic obstructive pulmonary disease (COPD), which alters compliance of the pulmonary artery.

Salbutamol is a selective short-acting beta2-agonist and when inhaled during OLV, it acts selectively on the pulmonary vasculature reducing pulmonary vascular resistance of well-ventilated lung. We hypothesized that inhaled salbutamol would alleviate ventilation-perfusion mismatch during OLV of COPD patients, and aimed to assess the effects of salbutamol on oxygenation in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient age 40\~80yrs, scheduled for videoscope-assisted pulmonary lobectomy
* American Society of Anesthesiologists Class III 또는 IV
* Moderate or more severe COPD according to GOLD criteria (FEV1/FVC\<70%, FEV1\<80%)

Exclusion Criteria:

* New York Heart Association class \>II
* AST level ≥100 IU/mL or ALT ≥ level 50 IU/L
* Creatinine clearance \< 30mL/min
* History of severe coronary artery occlusive disease, unstable angina, or recent myocardial infarction within 6 months
* History of pulmonary hypertension or pulmonary edema
* History of cerebrovascular accident within 3 months
Identifying Student Opinion Leaders to Lead E-cigarette Interventions

This research will explore the feasibility of leveraging social network analysis to identify 6th grade opinion leaders to lead a school-based e-cigarette intervention. The project will be conducted for 6th graders in 8 schools in the Pittsburgh area.

Specific Aim 1: Participants will be recruited from 8 Pittsburgh-area schools. The investigators will conduct a social network survey for all 6th graders in each school. Students will be asked to identify their closest peers based on several relationship dynamics: friendship, opinion leadership, academic support, and personal support.

Specific Aim 2: The investigators will adapt modules from CATCH My Breath, an evidence-based, school-implemented e-cigarette intervention supported by University of Texas and MD Anderson Cancer Center. The 8 schools will be randomized to receive the intervention led by either (1) an adult content-expert or (2) a peer-nominated opinion leader to students who nominated them or (3) a peer-nominated opinion leader to students who did not nominate them. Surveys will be administered before and after the intervention. Primary outcomes will be acceptability and feasibility measures, including (1) recruitment and (2) retention rates. Secondary outcomes will include e-cigarette use, intention-to-use e-cigarettes, and knowledge about e-cigarettes.

Eligibility Criteria:
Inclusion Criteria:

* 6th grade student at Linton, Founder's Hall, Woodland Hills, Steel Valley, Greensburgh Salem, Freedom, Marion, or Rostraver schools

Exclusion Criteria:

* Students who are unable to read the surveys will be excluded from data collection. However, all students will still participate in the e-cigarette program
Telerehabilitation in People With Long COVID

The aim of our study is to investigate the effectiveness of telerehabilitation in Post-COVID patients.

Decreased exercise capacity, persistent dyspnea and easily fatigue are found in some Post-COVID patients. Telerehabilitation has been developed in cardiac and pulmonary diseases such as coronary artery disease and chronic obstructive pulmonary disease for years with good clinical outcomes. However, little is known about the effectiveness of home-based telerehabilitation among Post-COVID patients. Thus, we want to investigate the effectiveness of telerehabilitation among Post-COVID patients, including cardiorespiratory fitness, physical activity amounts, health related quality of life and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

Individuals who had been diagnosed with COVID-19 positive and whose last PCR test or rapid antigen test was negative with the following criteria:

* aged between 20 to 80 years old
* persistent symptoms at least 4 weeks after recovery from COVID-19 infection, including any of the following symptoms: dyspnea, fatigue, cough, headache, chest tightness, palpitations, loss of smell, anxiety, insomnia, brain fog or joint pain
* able to speak and understand Mandarin
* able to walk including those who need the walking aid
* had mobile phones and could easily access the Internet

Exclusion Criteria:

* a history of chronic obstructive pulmonary disease or other respiratory diseases
* a history of arrhythmia,cancer, end-stage renal disease with dialysis, being diagnosed with mental illness, recent stroke within 6 months
* inability to participate because of comorbid neurological or musculoskeletal conditions that produce moderate to severe physical disability
* need all day oxygen support
Investigation of Occupational Balance in Individuals With and Without Bruxism

Considering that occupational balance and bruxism are negatively affected by stress, this study aims to determine whether there is a difference in terms of occupational balance between individuals with and without bruxism.

Occupation refers to daily life activities and task groups that are named, organized, given value and meaning by individuals and a culture. Occupation is everything people do to keep themselves busy, including taking care of themselves, enjoying life, and contributing to the social and economic fabric of their communities.

Bruxism is a parafunctional habit among temporomandibular disorders that occurs as a result of clenching and grinding teeth and overloading the stomatognathic structures. At the same time, bruxism is the chewing movement of the mandible, characterized by involuntary, rhythmic and non-functional teeth clenching and grinding, usually seen during sleep, and manifested by severe head and neck pain, limitation in jaw movements, pain and spasm in the chewing muscles. Although its etiology cannot be fully explained, it is thought that factors such as stress, occlusal disorders, allergies and sleep quality may be the source.

The deterioration or decrease in occupational balance may also be associated with people's quality of life. Occupational imbalance is reported to affect both physical and psychological state, creating significant stress on the body and mind, causing mental health problems and burnout.

Considering that occupational balance and bruxism are negatively affected by stress, this study aims to determine whether there is a difference in terms of occupational balance between individuals with and without bruxism.

Eligibility Criteria:
Inclusion Criteria:

* To be volunteer

Exclusion Criteria:

* Psychological disorders,
* Neurological disorders,
* Orthopedic disorders,
* Cognitive impairment.
Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care.

This study evaluate the capacity of the MON4STRAT device for drug monitoring of β- lactam antibiotic concentrations in newborns, children, and adolescents admitted in intensive care units with a health care-associated infection.


Eligibility Criteria:
Inclusion Criteria:

* Age younger than 18 years
* Newborns (preterm or not) in neonatal intensive care
* Infants, children, and adolescents in pediatric intensive care
* Clinically suspected or microbiologically proven sepsis that might be associated with ventilator-associated pneumonia or otherwise associated with health care
* Need for antibiotic treatment by piperacillin-tazobactam, ceftazidime, or meropenem of intermittent administration
* Informed consent form signed by parents/guardian
* Informed consent form signed by patients old enough to understand.

Exclusion Criteria:

* Process for active limitation of treatment underway
* Suspected or known hypersensitivity to studied beta-lactams
* Renal failure, defined as serum creatinine \> 1.5 mg/dl or urine production \< 0.3 ml/kg for 24 h or anuria for 12 h.
* Co-administration of two β-lactam antibiotics
* Cystic fibrosis
* No national health insurance coverage in French center
* Family unable to understand study-related information due to language or other communication issues
* No consent obtained
Next-Gen MS: Feed-forward PRO Data for MS Research

This Next Generation learning health system for Multiple Sclerosis (Next-Gen MS) study is a sub-study of the MS-LINK™ Outcomes Study (NCT04735406). The study aims to examine the effects of using feed forward Patient Reported Outcomes (PROs) data in real-world Multiple Sclerosis (MS) care settings. The study will be conducted within an emerging Learning Healthcare System (LHS).


Eligibility Criteria:
Inclusion Criteria:

* Participants willing and able to provide written informed consent
* Participants with clinical diagnosis of Multiple Sclerosis (MS)

Exclusion Criteria:

* None
Stress Management Modified Cardiac Rehabilitation in Patients After Acute Myocardial Infarction or Heart Failure

The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure.

The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure. The investigators performed modified cardiac rehabilitation program involving stress management on the patients who suffered from acute myocardial infarction or severe heart failure who were admitted to the CCU. Then the psychological states, quality of life and clinical outcomes were followed up.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years old with a diagnosis of AMI (include ST segment elevated myocardial infarction and non-ST segment elevated myocardial infarction) or heart failure

Exclusion Criteria:

* Uncontrolled tachycardia (heart rate at rest \>120bpm
* Uncontrolled polypnea（breath rate at rest \>30 breath per minute
* Uncontrolled respiratory failure （SPO2 ≤90%）
* Uncontrolled hypertension （pre-exercise SBP\>180mmHg or DBP\>110mmHg）
* Weight change in 72 hours \>1.8kg
* Uncontrolled hyperglycemia (Random blood glucose\>18mmol/L)
* Uncontrolled malignant arrhythmia with hemodynamic instability
* Unoperated pseudoaneurysm、artery dissection
* Uncontrolled septic shock and septicopyemia
* Unoperated severe valvular heart disease or acute phase of heart failure caused by myocardial heart disease
* nervous system disease, motor system diseases and rheumatic diseases considered possibly worsened by exercise
* Uncooperation of the patients
Effect of Folic Acid Treatment in Coronary Artery Disease

We seek to examine the effects of folic acid treatment on vascular function in patients with coronary artery disease. Our hypothesis is that folic acid treatment will improve vascular function

Common vascular disease states including diabetes and atherosclerosis are associated with endothelial dysfunction, characterised by reduced bioactivity of nitric oxide (NO). Folates are thought to improve endothelial function,but the mechanism by which this effect occurs is poorly understood. We propose to study the effects of folate supplementation on endothelial function in patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of coronary artery disease

Exclusion Criteria:

Recent acute coronary event Renal and/or hepatic dysfunction Metallic implants
Sternal Closure in Children After Cardiac Surgery

comparison between stainless steel wires and PDS in closure of sternum in children after cardiac surgery in terms of sternal dehiscence, infection \& cosmetic outcome

Median sternotomy is considered to be the gold standard incision in cardiac surgery. Sternotomy has to be performed properly to avoid short- and long-term morbidity and mortality. The surgical technique is well established and certain principles are recognized to be crucial to minimize complications. The identification of the correct landmarks, midline tissue preparation, osteotomy with the avoidance of injury to underlying structures like pleura, pericardium and ectatic ascending aorta, and targeted bleeding control are important steps of the procedure. As important as the performance of a proper sternotomy is a correct sternal closure. An override or shift of the sternal edges has to be avoided by placing the wires at a proper distance from each other without injuring the thoracic pedicle. The two sternal halves have to be tightly re-approximated to facilitate healing of the bone and to avoid instability, which is a risk factor for wound infection. With a proper performance of sternotomy and sternal closure, instability and wound infections are rare and depend on patient-related risk factors . Conventional closure uses stainless steel wire sutures which may not be the ideal approach as sternal wound infection and mediastinitis are troublesome complications following this method which are major causes of morbidity and mortality of patients. Availability of delayed absorbable sutures such as polydioxanone sutures (PDS) for sternal closure allows us to test the efficacy of it in prevention of these complications.

Eligibility Criteria:
Inclusion Criteria:

* Infants \& children up to 5 years old underwent open heart surgery in Assiut University heart hospital

Exclusion Criteria:

* Older than 5 years old
Novel Multifocal Soft Contact Lens Study

A single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the study site for one visit. Ocular health assessments and visual acuity will be completed with both the study lens and without.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to give informed consent
2. Any gender
3. Any racial or ethnic origin
4. 18 - 40 years of age
5. Distance visual acuity with best corrected visual acuity of 20/25 with each eye
6. Habitual soft contact lens wearer with myopia
7. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the investigator).

Exclusion Criteria:

1. Current or active ocular inflammation or infection as determined by the Investigator.
2. Astigmatism \> 0.75 D in either eye
3. History of previous eye surgery
4. Demonstration or history of corneal ectasia or keratoconus.
5. Pregnant or lactating.
HOPE (Harnessing Online Peer Education): Using Online Social Networks for HIV Prevention and Testing

This study seeks to determine whether social networking technologies can be used to increase HIV prevention and testing.The HOPE (Harnessing Online Peer Education) model seeks to apply a diffusion of innovations style intervention to social media to increase HIV testing.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Has had sex with a man in the past 12 months
* Lives in Lima or Callao, Peu
* Has a Facebook account or willing to create one

Exclusion Criteria:

* Does not satisfy inclusion criteria