cyrilzakka/clinical-trials huggingface dataset:
Simulation Team Training and Critical Event Checklist Use for Optimizing the Management of Critical Perioperative Events in an Ambulatory Surgical Facility

This study will determine if operating room teams manage a simulated event more effectively using a critical event checklist. Performance will be evaluated using a score based on how closely they follow a protocol for critical event management; a 'team' score and a score based on clinical recovery of the simulated patient. All teams will receive a debriefing session after managing 4 scenarios. Teams will return and manage 4 further scenarios after a period of 6-9 months.

The investigators will be testing the hypothesis that both clinical and behavioral team performance will improve with the use of Critical Event Checklists. The investigators also expect that health professional (participant) could attain knowledge related to the importance of non-technical skills and the use of CECs in the management of critical events.


Eligibility Criteria:
Inclusion Criteria:

* Eligibility Criteria for Participation:

  1. RN in active practice
  2. Anesthesiologist in active practice
  3. Surgeon in active practice

     Exclusion Criteria:
Evaluation of the Muscular and Cutaneous Sodium Storage by 23Na MRI in Patients With Chronic Adrenal Insufficiency

This study investigates the sodium content in the calf muscle and the skin obtained via 23Na-magnetic resonance imaging in patients with chronic adrenal insufficiency compared to healthy controls.

Patients with chronic adrenal insufficiency depend on lifelong glucocorticoid and mineralocorticoid replacement therapy. Monitoring is based on clinical and laboratory parameters reflecting hemodynamic stability, electrolyte status and plasma renin concentration. Reduced subjective well-being is however often described by these patients in absence of clinical or laboratory abnormalities and is thus a strong indicator of the gap between the concept of adequate hormone substitution and patients' requirements. This study investigates the sodium content in the calf muscle and the skin obtained via 23Na-magnetic resonance imaging (MRI) in patients with chronic adrenal insufficiency compared to age-, sex- and BMI- matched healthy controls. The aim of the study is to evaluate the potential role of 23Na-MRI for monitoring of hormone replacement by investigating tissue sodium concentrations in patients with adrenal insufficiency.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Written informed consent
* Chronic adrenal insufficiency (first diagnosis \> 6months), stable hormone replacement therapy with glucocorticoids (no dose-adjustment \>50mg hydrocortisone within the last 8 weeks) and mineralocorticoids (only primary adrenal insufficiency)! Or healthy control (no adrenal insufficiency, normal serum-electrolytes, normotensive blood pressure, no medication with a known influence on the electrolyte balance)!

Exclusion Criteria:

* Pregnancy or breast-feeding
* Metal-implant (not MRI-compatible)
* Claustrophobia
* Chronic internistic disease (hypertension, heart failure, liver cirrhosis)
* Polydipsia (\>4l/d)
* Long-term medication that can cause a hyponatraemia (for example diuretics)
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer

The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years of age or older
* Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)
* Participants must plan to initiate chemotherapy and/or radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt
* Participants must be able to speak and read Spanish and/or English
* Participants must be able to provide informed consent

Exclusion Criteria:

* Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)
* Use of feeding tubes at the time of study enrollment
Study of the Geometry of the Immature Human Femur Before the Age of 3 Years From Data Measured on CT Scan

Childhood fractures are the second most common presentation of abuse. The target population for screening for these injuries is children under the age of three who are unable to express themselves about the circumstances of the trauma, hence the need to develop a validated model to predict the outcome of trauma as well as the origin of a fracture.

Few morphological data are available in the literature for the femur concerning the period of rapid growth between 0 and 3 years of age.


Eligibility Criteria:
Inclusion criteria:

* Minor patient who died before the age of 3 years
* Whole body CT imaging performed post mortem on judicial requisition in the framework of a forensic procedure
* Absence of refusal in the medical file by the holders of parental authority concerning the re-use of their child's data for the purposes of this research

Exclusion criteria:

* Refusal manifested in the medical record by parental authority holders regarding the reuse of their child's data for the purpose of this research,
* Femur not fully assessable on imaging acquisition
Improving 24-hour Blood Pressure Stability in Spinal Cord Injury with Low Oxygen Therapy

This study examines the effects of low oxygen therapy (LOT) on the stability of 24-hour blood pressure in persons with chronic cervical spinal cord injury.

This study will examine if brief episodes of breathing lower oxygen, termed low oxygen therapy (LOT), which has been shown to enhance autonomic nervous system activity, can improve blood pressure stability in individuals with spinal cord injury. The research team will assess 24-hour blood pressure, as well as cardiac, vascular, and autonomic function before and after a 4-day LOT treatment intervention. This study will advance current understanding of treatments to mitigate cardiovascular disease risk in people with spinal cord injuries.

Spinal cord injury (SCI) interrupts signals travelling down from the brain to the rest of the body below the level of the injury. The loss of nerve connections involved in cardiovascular control results in blood pressure instability. This can lead to sudden drops in blood pressure, such as when shifting upright or during transfers, or sudden increases during autonomic dysreflexia. These swings in blood pressure are linked to a nearly 4-fold increase in the risk of cardiovascular disease in people with SCI.

Repeated, brief exposure to breathing lower levels of oxygen, termed low oxygen therapy, has been shown to stimulate adaptation in the nervous system. This neuroplasticity increases the activity of cardiovascular control circuits, and has been shown to increase blood pressure in able-bodied individuals. Similar effects on respiratory and motor function in people with SCI, but the effects on the cardiovascular system have not been studied in this population.

This study will test the effects of a 4-day low oxygen therapy intervention on 24-hour blood pressure stability in people with chronic cervical SCI. By assessing mechanisms of cardiac, vascular, and autonomic function, this study aims to improve current understanding of the therapeutic potential of low oxygen therapy to mitigate cardiovascular disease risk in SCI.

Eligibility Criteria:
Inclusion Criteria:

* Are between the ages of 19-65
* Living with a chronic cervical (at or above T1) spinal cord injury of at least one year
* Are fluent in english

Exclusion Criteria:

* High-cervical injuries requiring ventilator assistance to breathe will be excluded on account of the necessity of the facemask for the delivery of hypoxia
* Unhealed fracture, contracture, or pressure sore that might interfere with participants' ability to complete the protocol
* Additional concurrent neurological conditions (e.g., multiple sclerosis, Parkinson disease, stroke or brain injury)
* Uncontrolled cardiovascular or pulmonary disease
* Severe neuropathic pain
* Severe recurrent autonomic dysreflexia
* History of seizure disorders
* Known pregnancy
A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine

The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine.

The study will last about 6 weeks, and includes 4 visits.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a history of migraine headaches for more than 6 months
* Participants must have a history of 2 to 15 migraine headaches per month in the past 2 months
* Participants must weigh between 15 and 55 kilograms (kg)
* Participants must not have a migraine headache on the day of lasmiditan administration

Exclusion Criteria:

* Participants must not be pregnant or nursing
* Participants must not have any acute, serious, or unstable medical condition

  * Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
* Participants must not be on a medicine that acts in the brain and spinal cord
Measurement of Beta Cell Death in Individuals With Cystic Fibrosis

This study evaluates the feasibility of using differentially methylated insulin DNA, a biomarker of beta cell death, in determining the time course of beta cell death and development of diabetes in people with cystic fibrosis. Study participants with cystic fibrosis and healthy control participants will have a blood sample drawn in order to measure the levels of differentially methylated insulin DNA.

Cystic fibrosis related diabetes (CFRD) causes increased morbidity and mortality in people with cystic fibrosis (CF). The prevalence of CFRD increases with age. While CFRD is diagnosed in only 2 percent of children under 10 year sof age, it is present in 19 percent of adolescents and up to 50 percent of adults with CF. Although CFRD is uncommon in children, recent animal and human studies have shown that milder glycemic abnormalities are common in infants and young children with CF. One of the proposed mechanisms for early glucose dysregulation in CF is related to ongoing beta cell death that may start at a very early age. The assay to be used in this study measures differentially methylated insulin DNA, released exclusively by beta cells, to determine levels of beta cell death. This assay has been shown to detect beta cell death in individuals at risk of developing type 1 diabetes. If this assay successfully detects beta cell death in individuals with CF, the investigators can identify critical time points of beta cell loss in people with CF. Understanding how and when glycemic dysregulation occurs in CF will lead to better treatment of CFRD in the future.

Eligibility Criteria:
Inclusion Criteria for Cystic Fibrosis Subjects:

* Age 0 - 21 years
* Diagnosis of CF by two CF-causing mutations or elevated sweat chloride test
* Normal glucose tolerance, impaired glucose tolerance, indeterminate glucose tolerance or CFRD
* Pancreatic insufficiency

Exclusion Criteria for Cystic Fibrosis Subjects:

* Age \> 21 years
* Diagnosis of type 1 or type 2 diabetes
* Pregnancy
* Oral or IV steroid use in the past 2 weeks
* Pulmonary exacerbation requiring hospital admission in the past 2 weeks.
* Initiation of CFTR corrector or potentiator medication within 6 months

Inclusion Criteria for healthy, age-matched controls:

* Age 0 - 21 years

Exclusion Criteria for healthy, age-matched controls:

* Age \> 21 years
* Diagnosis of type 1 or type 2 diabetes or pre-diabetes
* Disorders impacting pancreatic exocrine function
* Pregnancy
* Oral or IV steroid use in the past 2 weeks
The Difference in Duration of Sciatic Nerve Block Between Diabetic and Non-diabetic Patients

This study aims to compare the sensory and motor block duration and the incidence of nerve injury after sciatic nerve block between diabetic and non-diabetic patients, and screen for the factors that may affect the block recovery.

This is an observational study. All participants who experienced unilateral lower limb surgery and received an ultrasound-guided (nerve stimulator assisted) subgluteal sciatic nerve block with 0.75% ropivacaine 20ml in Peking Union Medical College Hospital were selected. They were further assigned to either diabetic group or non-diabetic group according to their medical history (primary exposure). The primary end point was the sensory and motor block duration. These durations in terms of sensory and motor blocks of sciatic nerve(dorsal side, plantar side) were assessed at baseline, every 2 hours in 48 hours after the block (except for the second night). In addition, the associations between fasting blood glucose, glycosylated hemoglobin (hemoglobin A1c, HbA1c) and the degree of diabetic retinopathy and the durations of sensory and motor block were also examined. This is not a intervention study, because we will examine the outcomes between diabetic or non-diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists :I-III;
* Age\>=18 years;
* Undergo unilateral lower limb surgery;
* Sign consent form.

Exclusion Criteria:

* Refuse regional Anesthesia;
* Thresh of sensory \>10g;
* Dyskinesia;
* Bleeding disorder;
* Regional skin infection;
* Regional drug allergy;
* Renal disfunction;
* Incompliant to study;
* Drug abuse.
A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke

This clinical RCT study intends to combined different forms of multi-channel tDCS with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction.

The therapeutic effects among single-channel tDCS group, multi-channel tDCS and pseudo-multichannel tDCS group will be compared. Brain magnetic resonance mechanism research will also be included to reveal the possible mechanism of multi-channel tDCS technology for PSCI brain network.

Thus, the efficacy and mechanism of multi-channel tDCS in post-stroke cognitive function rehabilitation will be researched both in the clinical and basic levels.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 year-old
* diagnosed cerebral apoplexy, meeting the diagnostic criteria of ICD-10
* cognitive function, perceptual function decline after stroke
* first onset and duration of 3-12 months
* right-handed
* MMSE ≤25
* MoCA ≤25
* sign informed consent voluntarily and comply with the study plan

Exclusion Criteria:

* NIHSS ≥21 points
* MoCA ≤18, or DRS-2 ≤ 124, or CES-D ≥ 16
* taking drugs that affect central nervous activity, such as nerve antagonists
* specific contraindication, such as electrode patch allergy, local skin injury or - - - - inflammation, and hyperalgesia in stimulated areas
* patients use implantable electronic devices (such as cardiac pacemakers) or have - metal implants such as stents that affect MRI examination
* patients with a previous history of epilepsy, mental illness or skull injury
* patients with dementia or obvious cognitive dysfunction before stroke
* patients with aphasia or dysarthria and cannot complete the scale evaluation
* pregnancy
Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)

Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied for prophylaxis of venous thromboembolism after major orthopedic surgery. Additionally, RXA is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and for prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.

This is an explorative laboratory study to evaluate the intra-individual variability of RXA conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.

Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied for prophylaxis of venous thromboembolism (VTE) after major orthopedic surgery of the lower limbs such as hip and knee replacement surgery. Additionally, RXA is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and for prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.

Monitoring of RXA concentration (conc.) is generally not required because of its stable pharmacokinetic and pharmacodynamic profile, even in patients with renal insufficiency. However, there are several clinical situations, in which it may be desirable to measure the RXA plasma conc. The range of RXA conc. is wide among individuals with typical peak levels of median 244 µg/L (IQR 175-360) and trough levels of median 32 µg/L (IQR 19-60) with once daily doses of 20 mg RXA.

This is an explorative laboratory study to evaluate the intra-individual variability of RXA conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.

Eligibility Criteria:
Inclusion Criteria:

Male, aged 18-65 years

* No known comorbidity or disease
* No known galactose intolerance, lactase deficiency or glucose galactose malabsorption
* Taking no other medicaments
* No history for disorders regarding hemostasis
* Initial screening laboratory test showing normal values for liver/pancreas function (ALAT,ASAT,gGT, alkalic phosphatase, bilirubin, amylase, lipase), kidney function (creatinine), hematogram (white blood cell count, hemoglobin, platelet count), and coagulation parameters ("Gerinnungsstatus" with PT, aPTT, fibrinogen, thrombin time)
* written informed consent

Exclusion Criteria:

* none
Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIIA-IIIB Resectable NSCLC (FORESEE)

In this open-label, single-arm, phase 2 study, 40 eligible patients with EGFR mutated stage IIIA-IIIB resectable NSCLC will be recruited to receive furmonertinib for 9 weeks combined with cisplatin/pemetrexed for 3 cycles (21 d/cycle) as neoadjuvant therapy before radical surgery. Radiological and pathological evaluations will be performed before and after the neoadjuvant therapy to assess the efficacy of treatment. Adverse events during neoadjuvant therapy, disease and survival status will also be collected in the study.


Eligibility Criteria:
Inclusion Criteria:

* With written informed consent before any study procedure
* Histology or cytology diagnose of non-small cell lung cancer within 60 days
* Stage IIIA/IIIB, with resectable lesion(s) by radiology
* EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
* Without prior anti-tumor treatment
* With at least one measurable lesions (The longest axis ≥10mm)
* ECOG performance status 0-1
* Using adequate and effective contraception, women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age

Exclusion Criteria:

* EGFR Exon 20 insertions positive
* Mixed with small cell cancer, or other mixed types of lung cancer
* Any prior anti-tumor treatment
* Major surgery within 4 weeks before enrolment
* Women with pregnancy or breastfeeding
* Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrolment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrolment
* With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
* With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
* Severe gastrointestinal diseases which may affect the intake and absorption of study drug
* Prolongation of ECG QTc or with relative risk factors
* History of interstitial lung disease or with relative risk factors
* Inadequate organ function of hematology, liver and kidney
* Allergic to study drugs or any component
* Poor adherence or other situation judged by investigator
* Patients who had participated other clinical studies of tumors
Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery

Respiratory depression occurs in labor and delivery; noticeably when neuraxial opioids are given.Pathophysiological respiratory depression -failure to respond to hypercapnia or hypoxia - is challenging to measure clinically.American Society of Anesthesiologist guidelines recommend suitable respiratory monitoring for 24 hours post cesarean delivery (CD).

Use of capnograph will enable us to assess breath-by-breathe respiration in a population receiving neuraxial opioids - potentially at risk for respiratory depression.

Our aim is to assess our ability to capture maternal postpartum respiratory parameters in a cohort following opioid neuraxial administration for CD.

The investigators wish to test the efficacy of capnograph in detection of apnea and respiratory depression in women following cesarean delivery. Currently, routine intensive monitoring such as the investigators propose is not performed, and many apneas may go undetected.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status class I or II
* Age between 18 and 45
* Gestational age greater than 37 completed weeks
* Singleton pregnancy.

Exclusion Criteria:

* Contraindication for neuraxial analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
* Allergies to postoperative medication (opioids, NSAIDs, acetaminophen)
* Chronic opioid use
* Opioid administration in the previous 12 hours
* Inability to adequately understand the consent form
* Blocked nose or nasal deformity.