Kornimate/medical-research-clean huggingface dataset:
a multicentre preoperative fasting audit

Conditions: Pulmonary Aspiration of Gastric Contents

Summary: the new european society of anaesthesiology and intensive care (esaic) preoperative fasting guideline recommends a one hour minimum fasting time for clear fluids. this represents a major change in the practice of pediatric anaesthesia. during the transition to shorter fasting times on a global scale, we need a large multicenter audit to monitor the incidence of pulmonary aspiration.

the purpose of preoperative fasting is to achieve an empty stomach at the time of anaesthesia induction. most current fasting guidelines all take into account the balance between the risk of pulmonary aspiration and the harmful effects of prolonged preoperative fasting. however, there is increased awareness among pediatric as well as general anaesthesiologists that many patients suffer from prolonged duration of fasting in spite of the reasonable nominal respective limits of 6-4-2 hours. prolonged fasting may be harmful, especially in small children, but also in adults with a poor nutritional status. the new european society of anaesthesiology and intensive care (esaic, 2022) preoperative fasting guideline recommends a one-hour minimum fasting time for clear fluids. this represents a major change in the practice of paediatric anaesthesia. during the transition to shorter fasting times on a global scale, we need a large multicentre audit to monitor the incidence of pulmonary aspiration. the primary aim of the european preoperative fasting audit (eurofast) is to determine the safety of reducing the required fasting time for clear fluids to at least one hour in children fasting before elective procedures requiring general anaesthesia (as recommended in the esaic guideline).

Eligibility criteria:
inclusion criteria: * children, age \< 16 years old * general anesthesia exclusion criteria * age \> 15 years * procedure without general anesthesia * general anesthesia performed at center with less than 1000 pediatric cases per year

Keywords: preoperation fasting general anesthesia children pulmonary aspiration of gastric contents
fgf21 and its role in alcohol dependence

Conditions: Alcohol Abuse or Dependence

Summary: plasma fibroblast growthfactor-21 (fgf21) responses to acute alcohol exposure will be evaluated in three groups: a: 15 individuals diagnosed with alcohol dependence (icd10 code f10.2) and no alcoholic liver diseases, b: 15 healthy individuals with one or two parents with alcohol dependence, and c: 15 healthy matched controls without history of or disposition to alcohol dependence. the experimental day consists of a load of 0.5 g ethanol per kg body weight ingested from time 0-10 minutes followed by a 7 h period in which blood will be sampled with frequent intervals, rating of preference for ethanol, salt, sour, bitterly and sweets, sensations of hunger, appetite, satiety, headache, and nausea will be evaluated using visuel analogue scale and resting energy expenditure will be evaluated using indirect calorimetry.


Eligibility criteria:
inclusion criteria: * informed consent * caucasian males between 25 and 65 years of age * bmi between 19 and 27 kg/m2 * normal haemoglobin * normal fasting plasma glucose concentration (\< 6 mmol/l) and normal glycated haemoglobin a1c (hba1c) (\< 42 mmol/mol) participants with a father diagnosed with alcohol dependence (group b): * father diagnosed with alcohol dependence * weekly alcohol intake of less than 14 units of alcohol (of 12 g) * normal alcohol use disorders identification test (audit) score healthy participants (group c): * weekly alcohol intake of less than 14 units of alcohol (of 12 g) * normal audit score exclusion criteria: * liver disease evaluated by plasma alanine aminotransferase (alat) \> 3 × normal level, an international normalised ratio (inr) below normal values, or biopsy-verified alcoholic liver disease * diabetes mellitus * anaemia * nephropathy * other diseases the investigator finds disruptive for participation in the study. participants with a father diagnosed with alcohol dependence (group b): - former alcohol dependence or abuse healthy participants (group c): * first-degree relatives with diabetes, liver disease and/or alcohol dependence * former alcohol dependence

Keywords: alcohol fgf21 alcohol dependence
nutritional supplements and performance during visual field testing (b3 vitamin)

Conditions: Visual Field Defect, Peripheral; Glaucoma, Open-Angle

Summary: this study seeks to test whether these over-the-counter nutritional supplements have an impact on patients' performance during visual field testing.

glaucoma is the leading cause of irreversible blindness worldwide. the most important test to detect progression is visual field testing. visual field testing is the reference standard to measure visual function in glaucoma. it is called called standard automated perimetry (sap). however, this test is very subjective, often unreliable, and variable. one of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. previous studies have shown that listening to mozart or taking vitamin b12 can improve the reliability of this test. recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin b3) and pyruvate can also improve the performance during this test. this can ultimately reduce costs due to repeated testing and increase doctor's certainty when analyzing the results of this test.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of primary open-angle glaucoma; * visual field loss on 24-2 standard automated perimetry (sap) worse than -3 decibels (db) and better than -12 db in both eyes; * best corrected visual acuity better than 20/40 in both eyes; * prior experience with 24-2 visual fields (at least 3 tests done in the past 3 years). exclusion criteria: * significant cataract or media opacity; * diagnosis of dementia, alzheimer's, and other neurological diseases; * current use or use in the past 1 month of nutritional supplements; * inability to take or intolerance to nicotinamide and/or pyruvate.

Keywords: perimetry vitamins glaucoma supplements vitamin b3 nicotinamide
the additive effect of cognitive behavioral treatment (cbt) to conventional weight loss intervention program for young adults with intellectual disabilities

Conditions: Overweight; Obesity; Learning Disability

Summary: in this randomized case control study we will evaluate the additive effect of psychological intervention, i.e cbt-cognitive behavioral treatment in a multi-strategy weight loss program composed of physical activity intervention and nutritional programme.


Eligibility criteria:
inclusion criteria: * subjects with over-weight or obese subjects with learning disability who have completed "nitzan onim" two-year training program and live in housing within the community * subjects who sign an informed consent exclusion criteria: * subjects with out over-weight or obese subjects with out learning disability subjects who have no completed "nitzan onim" two-year training program and live in housing within the community

Keywords: over-weight or obese subjects with learning disability who have completed "nitzan onim" two-year training program and live in housing within the community
study of the large diameter gore excluder® aaa endoprosthesis in abdominal aneurysms

Conditions: Aortic Aneurysm, Abdominal

Summary: the purpose of this study is to assess the safety and efficacy of the 31 mm gore excluder® aaa endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms

the primary objective of this study was to estimate the safety of the 31 mm gore excluder® aaa endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. a secondary objective was to compare device performance of the original gore excluder® aaa endoprosthesis to the 31mm excluder when used in the treatment of infrarenal abdominal aortic aneurysms.

Eligibility criteria:
inclusion criteria: * infrarenal aaa \> or equal to 4.5 cm in diameter * proximal infrarenal aortic neck length \> or equal 15mm * anatomy meets 31mm excluder specification criteria * access vessel able to receive 20 fr. introducer sheath * life expectancy \>2 years * surgical candidate * asa class i, ii, iii, or iv * nyha class i, ii, iii * 21 years of age or older * male or infertile female * ability to comply with protocol requirements including follow-up * signed informed consent form exclusion criteria: * mycotic or ruptured aneurysm * participating in another investigational device or drug study within 1 year * documented history of drug abuse within 6 months * coexisting thoracic aortic aneurysm (50% larger than proximal aorta) * myocardial infarction or cerebral vascular accident within 6 weeks * pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function * renal insufficiency (creatinine \> 2.5 mg/dl) without dialysis * iliac anatomy that would require occlusion of both internal iliac arteries * "planned" occlusion or reimplantation of significant mesenteric or renal arteries * "planned" concomitant surgical procedure or previous major surgery within 30 days * previous prosthesis placement in the same position of the aorta or iliac arteries * degenerative connective tissue disease, e.g., marfans and ehlers danlos syndrome * proximal neck angulation \> 60 degrees * presence of significant thrombus at arterial implantation sites
ambispective, multicentre, open-label study evaluating the clinical outcomes of foot surgery using serf medical devices

Conditions: Foot Diseases

Summary: this clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (case 4.1) ambispective, multicentre, open-label, non-comparative. the primary objective of this study is to evaluate the reduction in patient pain and the restoration of walking. the study will also collect performance and safety data to assess the subject's outcomes and functional status. the target population for this study was any adult patient implanted with fast screws, fast plates, toe fast and veofix screws between november 2021 and october 2022. the investigation will be conducted in accordance with the investigation protocol, the laws and regulations (including the medical regulations (including the medical devices regulation 2017/745) and the iso 14155:2020, as well as in accordance with the ethical principles described in the declaration of helsinki. the collection of personal data will also be compliant with rgpd 2016/679.


Eligibility criteria:
inclusion criteria: * male or female subject of legal age at the date of implantation; * subject implanted with one or more implants: fast screw, fast plate, toe fast and veofix screw between november 2021 and october 2022; * subject able to understand the information and instructions given by the investigator; * subject with a social security affiliation. exclusion criteria: * vulnerable persons * people with contraindications (including pregnant women)
emergency capsule endoscopy in severe gi-bleeding

Conditions: GI-bleeding

Summary: primary objective: evaluation of capsule endoscopy in the emergency setting of severe gi-bleeding.


Eligibility criteria:
inclusion criteria: patients with signs of severe gi-bleeding (with melena or dark bloody stool) and hemodynamic instability (defined as (pre)collapse or map \ 110) and/or drop of hemoglobin \> 2g/dl/d and/or need of transfusion of minimum of 2 packed red cells exclusion criteria: missing consent form, pregnancy, origin of bleeding found in upper gi-endoscopy (e.g. blood in the stomach, ulcer, varices with signs of bleeding, mallory-weiss-tear, angiodysplasia (with signs of bleeding), refluxesophagitis la c or d) fresh bloody stool, known stenosis of the bowel, known site of bleeding, known inflammatory bowel disease

Keywords: gi-bleeding capsule endoscopy
intercare, mindfulness and compassion based intervention for parental burnout

Conditions: Parental Burnout; Burnout, Caregiver; Burnout

Summary: the goal of this clinical trial is to test the effectiveness of an adapted mindfulness and compassion-based intervention (ibap) in reducing parental burnout in chilean mothers who telework while living with children under 18 years old. the main questions it aims to answer are: * can the intervention reduce symptoms of parental burnout in the short term (3 months) and medium-term (6 and 9 months) compared to the control group? * can the intervention improve work engagement in the intervention group compared to the control group? participants will be randomly assigned to either the intervention group or the active control group. the intervention group will receive the ibap program while the active control group will receive a relaxation audio guide. both group will receive parental burnout educational material, invitation to a whatsapp group and a weekly email reminders. parental burnout (pba) will be measured at baseline, 3, 6, and 9 months, and work engagement will be measured at the same time points. researchers will compare the intervention group to the active control group to see if the ibm program is more effective in reducing parental burnout and improving work engagement,


Eligibility criteria:
inclusion criteria: * mother living with at leat one child over the same roof * telework at leat one day per week * work at leat three days per week exclusion criteria: * self reported acute severe depression * self reported psychotic disorder * self reported substance abuse

Keywords: parental burnout burnout mindfulness compassion intercare
clinical evaluation of the treatment of intellectual metastases by radiosurgery gamma knife by means of a support system by mask.

Conditions: Lung Cancer; Brain Metastases

Summary: the mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years. this trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. the primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. it will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.the expected benefit is an improvement of the comfort for the patients.


Eligibility criteria:
inclusion criteria: * subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery * subject requiring a radiosurgical treatment with lgk exclusion criteria: * subject having hurts of the brainstem or para-optics * pregnant women or in feeding period * subject having received previously a whole brain radiotherapy
effect of tadalafil on exercise capacity in pediatric fontan patients

Conditions: Single Ventricle

Summary: this pilot study is aimed at assessing the short-term effects of tadalafil on the hemodynamic response to exercise and exercise capacity in patients with fontan circulation. data regarding effect size and drug tolerability will be used in the design of a randomized multicenter trial. the long-term goal of this investigation is to systematically evaluate the effect of tadalafil therapy on exercise performance, quality of life, and delay of functional deterioration in patients with single ventricle physiology.


Eligibility criteria:
inclusion criteria: * patients who have undergone the fontan procedure (regardless of type of fontan connection or presence or absence of a fenestration) * age 8.0 to 35.0 years * stable clinical condition over the last 3 months (i.e. no change in medication, treatments, or development of new symptoms) * ability to perform exercise testing * consent and assent (as appropriate to participate in the study after receiving information concerning procedures, risks, and possible clinical benefits) o patients will be enrolled without regard to gender, race, and ethnicity. all patients meeting study eligibility will be approached for consent. exclusion criteria: * severe heart failure (new york heart association functional class iii or iv) * presence of liver or renal dysfunction based on the latest lab test results * presence of hearing or visual deficit * transcutaneous arterial blood oxygen saturation (sao2) \<80% at rest * history of echocardiographic, mri, or angiographic evidence of fontan pathway obstruction * history of exercise-induced life-threatening arrhythmias or unstable rhythm(i.e. atrial flutter) * known or suspected pregnancy. females in the reproductive age group will be screened for pregnancy using serum beta hcg prior to administering study drug. * patients on open label sildenafil or tadalafil

Keywords: fontan tadalafil exercise performance
extracorporeal shock wave and a tailored exercise program on axillary web syndrome

Conditions: Axillary Web Syndrome

Summary: a total of 93 suitable patients will be randomly allocated into three groups: group a will receive both low-energy extracorporeal shock wave therapy and a tailored exercise program, group b will receive only low-energy extracorporeal shock wave therapy, and group c will receive only the tailored exercise program.

patients were randomly assigned to one of three groups: group a, which received a low-energy extracorporeal shockwave treatment and a tailored exercise program; group b, which received only a low-energy extracorporeal shockwave treatment; and group c, which received only the tailored exercise program. the randomization process was done using a computer-generated table of random numbers concealed by sealed opaque envelopes. the patients' shoulder range of motion, pain intensity, upper extremity activities, and echogenicity, thickness, and disorganization were assessed using a digital inclinometer, visual analogue scale, quick dash scale, and diagnostic ultrasound, respectively. the randomization process was overseen by a professional physical therapist who was not involved in the study procedures. all outcomes were measured at the baseline and four weeks post-intervention. the outcomes were collected by a well-experienced investigator who was blind to the group assignments and considered as part of the research team.

Eligibility criteria:
inclusion criteria: * female * between the ages of 40 and 65 years exclusion criteria: * metastases of any kind * lymphedema, * a traumatic injury to the targeted upper extremity * a musculoskeletal disorder * taking any anticoagulants * had undergone bilateral breast cancer surgery * experienced locoregional recurrence * had vascular problems in the affected upper extremity

Keywords: axillary web syndrome shock wave exercises breast cancer surgery
visual outcomes of vivity in patients with high axial length

Conditions: Cataract

Summary: the objective is to assess the visual outcomes and quality of vision of patients receiving the acrysof® vivity intraocular lens (iol), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.

this study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. clinical evaluations will include administration of a visual disturbance questionnaire (quvid) and a satisfaction questionnaire (iolsat), as well as measurement of binocular and monocular visual acuities and manifest refraction.

Eligibility criteria:
subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. inclusion criteria: * undergoing uncomplicated bilateral cataract surgery with iol implantation. * gender: males and females. * age: 50 years or older. * willing and able to provide written informed consent for participation in the study. * willing and able to comply with scheduled visits and other study procedures. * motivated for greater degree of spectacle independence vs monofocal iol. * axial length ≥24.5mm in both eyes. * planned cataract removal by femtosecond laser. exclusion criteria: if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * ocular comorbidity that might hamper postoperative visual acuity. * previous refractive surgery. * irregular corneal astigmatism. * evidence of keratoconus as per pentacam. * expected post-op va worse than 20/25 (snellen). * refractive lens exchange. * difficulties comprehending written or spoken english language. * patients with physical or intellectual disability (e.g. down's syndrome, parkinson's disease; unable to fixate). * clinically significant or severe ocular surface disease that would affect study measurements based on the investigator's opinion. * axial length \<24.5mm. * evidence of macular pathology as per optical coherence tomography examination. the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Keywords: edof iol vivity
do phosphodiesterase 5a inhibitors improve exercise capacity in patients with chronic obstructive pulmonary disease (copd) and pulmonary hypertension?

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Summary: the investigators hypothesise that phosphodiesterase 5a inhibitors will improve exercise capacity in those with chronic obstructive pulmonary disease and secondary pulmonary hypertension.


Eligibility criteria:
inclusion criteria: * copd * forced expiratory volume in 1 second (fev1) \<80% (fev1/fvc \<0.70) * right ventricular systolic pressure (rvsp) \> 30 mmhg or pulmonary acceleration time \<120 ms exclusion criteria: * pulmonary stenosis or echo left ventricular outflow tract obstruction * left ventricular ejection fraction \< 45% * patients taking nitrates, nicorandil or doxazosin. * drug contraindications: * systolic blood pressure \<90 mmhg * recent stroke * unstable angina * past history of non arteritic anterior ischaemic optic neuropathy

Keywords: secondary pulmonary hypertension
a phase ii, adaptive trial design examining the pharmacokinetic and pharmacodynamic effects of modified release amphetamine (hld100, formulations b, c and e)) in adolescents and children with attention-deficit hyperactivity disorder (adhd)

Conditions: Attention-Deficit Hyperactivity Disorder

Summary: the main purpose of this study is to determine the rate and extent of absorption of one or more modified release formulations of amphetamine (hld100) in both adolescents and children with adhd.


Eligibility criteria:
main inclusion criteria * male and female adolescents (12-17 years; stage 1) and children (6-11 years; stage 2). * diagnosis of adhd and confirmed on kiddie-schedule for affective disorders and schizophrenia (k-sads). * adhd symptoms controlled on a stable dose of vyvanse, adderall xr and or dexedrine. * provision of informed consent (from parent\[s\] or legal representative\[s\]) and assent (from subject) for patients. main exclusion criteria * comorbid psychiatric diagnosis (e.g., psychosis, bipolar disorder). * history of seizures or current diagnosis or family history of tourette's disorder. * use of prescription drugs (except vyvanse, dexedrine or adderall xr) the 14 days and over-the-counter drugs (except birth control) the 30 days before the study.