Kornimate/medical-research-clean huggingface dataset:
the effect of oral and intravenous ramosetron during laparoscopic cholecystectomy

Conditions: Nausea; Vomiting; Laparoscopic Cholecystectomy

Summary: patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of postoperative nausea and vomiting (ponv). the investigators investigated the effect of oral and iv ramosetron on ponv prophylaxis after laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * asa i-ii patients, 25-65 years, electivelaparoscopic cholecystectomy under general anesthesia exclusion criteria: * gi disease, pregnant or menstruating, history of motion sickness and/or postoperative emesis, antiemetics within 24 h before surgery

Keywords: oral plus iv ramosetron may be more effective than iv ramosetron and oral ramosetron for the prophylaxis of ponv after laparoscopic cholecystectomy
epidemiologic study to evaluate the proportion of cardiovascular disease risk factors in korean hypertensive patients

Conditions: Hypertension

Summary: the purpose of this study is investigating the proportion of cardiovascular disease risk factors of hypertensive patients.

primary endpoint: to evaluate the proportion of patients with cardiovascular disease high risk factors secondary endpoint: to evaluate the proportion of patients with cardiovascular disease risk factors, to evaluate the proportion of patients with cardiovascular disease, to evaluate target blood pressure achievement rate according to the proportion of cardiovascular disease risks

Eligibility criteria:
inclusion criteria: * essential hypertensive patient no less than 18 yeas old * patient who gave informed consent form exclusion criteria: * patient was diagnosed as secondary hypertension * patient who have white-coat hypertension
a trial comparing pharmacokinetics, safety and tolerability of two subcutaneous concentrations of dapiglutide

Conditions: Overweight and Obesity

Summary: this is a phase 1, open-label, single-center, randomized, parallel-group trial designed to investigate the pharmacokinetic profiles, safety, and tolerability of a single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/ml and 25 mg/ml. the trial will be conducted in participants with a bmi ≥ 27.0 kg/m2.

dapiglutide is a dual glucagon-like peptide-1-/glucagon-like peptide-2 receptor agonist (glp-1r/glp-2ra) in clinical development for weight management. the purpose of this phase 1 trial is to compare pharmacokinetics (pk) of a single dose administration of 7.5 mg dapiglutide administered subcutaneously (s.c.) with two drug product concentrations, 10 mg/ml and 25 mg/ml and will be conducted in 30 participants with a body mass index (bmi) ≥ 27.0 kg/m2. the development of a drug product with higher drug concentration will facilitate investigation of a wider dose range of dapiglutide in the clinical development program of the compound. the pk profile of a weight management drug should be assessed in people with a wide range of bmi and with a bmi within the range of the target population as body weight is expected to influence pks of dapiglutide.

Eligibility criteria:
inclusion criteria: * age between 18 and 64 years, both inclusive, * bmi \>= 27.0 kg/m\^2 * hba1c \< 6.5 %. exclusion criteria: * any history or presence of a disorder or a disease, which, in the investigator's opinion, might jeopardize participant's safety, evaluation of results or compliance with the protocol, treatment with dapiglutide (any exposure) or any other drugs, including dual and tri agonists, involving a glp-1 ra or glp-2 ra within 180 days prior to screening. * any medication (prescription and non-prescription drugs) with the exception of stable treatment with antihypertensive and lipid-lowering drugs as well as thyroid replacement therapy. * female participants of childbearing potential who are not willing to use highly effective contraception until 42 days after dosing

Keywords: glp-1r/glp-2ra overweight obesity weight management
first-in-human evaluation of [18f]ceto

Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma; Primary Aldosteronism Due to Nodular Hyperplasia; Adrenal Cushing Syndrome; Non-Secretory Adrenal Adenoma; Adrenocortical Carcinoma

Summary: purpose of this clinical phase 1 trial was to determine if para-chloro-2-\[18f\]fluoroethyletomidate positron emission computed tomography (\[18f\]ceto-positron emission computed tomography(pet)/computed tomography(ct)) can be used in diagnostics of adrenal tumors and if the biochemical/pharmacological states conditions in humans with various illnesses, compared to healthy humans, such as the radio tracer is suitable?

after receiving oral and written information about the study and its potential risks, all participants provided written informed consent. all participants underwent a screening visit 1-28 days before their \[18f\]ceto pet/ct. at the screening visit their medical history was obtained, including besides information of previous disease(s) and medication, also a clinical examination, who performance status, height, weight, pulse rate and blood pressure, blood chemistry and haematology. right before the pet/ct investigation a baseline assessment was performed including: * a physical examination according to modified early warning score (mews) * 12-lead electrocardiogram (ecg) * any concomitant medications was recorded * medical history - occurrence of any new symptoms and events since the screening visit * hematology (international normalized ratio (inr) in patients with antiocoagulant treatment). * pregnancy test in women. * assessment of injection site monitored by visual inspection (rash and phlebitis) participants received on average 0,76 mikrograms (range 0,1-1.37 mikrograms) of administered mass of ceto in conjunction to the pet/ct investigation. potential adverse events were monitored closely during, and after the administration of \[18f\]ceto, with access to emergency medicine resources. each participant remained for observation at least 3 hours after administration of \[18f\]ceto and the following assessments were performed: * blood withdrawn for additional post-scan chemical analysis. * assessment of injection site monitored by visual inspection (rash and phlebitis). * mews the ten first participants were evaluated for serious adverse events/adverse events (sae/aes) the day after (approximately 24 hours after) performing the \[18f\]ceto pet due to the short half-life of the radionuclide used, fluorine- 18 (t1/2= 109.5 min). safety reporting was assessed by use of clinical adverse events and common toxicity criteria (ctc), laboratory and non-laboratory toxicities.

Eligibility criteria:
inclusion criteria: * patients diagnosed with adrenal incidentalomas with an concurrent overproduction of aldosterone or cortisol or no concurrent hormone production, or patients diagnosed with adrenocortical carcinoma * for healthy volunteers inclusion criteria included no known diseases, no ongoing medication and no known adrenal anomalies. exclusion criteria for patients and healthy volunteers: * pregnancy, age below 18, claustrophobia
using tests in preschool children with wheeze to determine the need for inhaled corticosteroid therapy.

Conditions: Wheezing

Summary: wheezing is common in preschool children and affects quality of life. although asthma treatments such as inhaled steroids (ics), which reduce swelling (inflammation) in the airways are used in this age group, they are often ineffective. that is because only some preschool children have the type of inflammation (known as type 2 inflammation) that responds to ics, thus many children are being unnecessarily exposed to side effects. it is difficult diagnosing type 2 inflammation through history and examination, thus other indicators are needed to ensure ics are only given to children who will benefit. these indicators are commonly known as biomarkers, and we are trying to find out if they are useful. we want to measure three biomarkers, without changing children's treatment. the first is blood eosinophils. which can be measured using a finger prick sample (like the blood drop used for measuring sugar levels in diabetic children). the second is to determine if allergic sensitization is present to allergens that are breathed in; these will be house dust mite, grass pollen, tree pollen, cat and dog hair. the final biomarker is a molecule that is produced in the airways of preschool children with type 2 inflammation, called nitric oxide (no). this is easily obtained, by having children breathe through a mask and collecting their breath in a bag, measuring no later on. the children will be followed up with monthly electronic questionnaires and 3-monthly visits (virtual or face-to-face) for a year to evaluate whether these markers individually or in combination relate to subsequent wheezing outcomes, and how acceptable the measurements are to families using a questionnaire and focus group approach. the results will form the basis of the design of a national trial of biomarker-driven therapy in such children.


Eligibility criteria:
inclusion criteria: 1. patients aged one to five years old presenting to primary care or emergency department or urgent care centre or identified from primary care records and have been diagnosed with wheezing by their gp or paediatrician who has decided to prescribe any bronchodilator, ics or montelukast on clinical grounds 2. parents/carers able to understand and familiarize themselves with the study and are willing to provide informed consent exclusion criteria: 1. inability to understand and cooperate with study procedures 2. significant co-morbidity (respiratory or otherwise), for example cystic fibrosis (excluding atopic disorders such as eczema, allergic rhinitis and food allergy) 3. withholding or withdrawal of informed consent 4. severe procedural anxiety (needle phobia) 5. child is already enrolled in another study involving investigational medicinal product (ctimp) 6. history of anaphylaxis or near-fatal asthma that resulted in intubation / assisted ventilation.

Keywords: preschool wheeze wheezing inhaled corticosteroids ics biomarkers
igf-i stimulation of collagen synthesis in ehlers-danlos patients

Conditions: Ehlers-Danlos Syndrome, Classic

Summary: the investigators want to inject insulin-like growth factor-i (igf-i) into the patella tendon of ehlers-danlos patients and healthy controls to evaluate the response in collagen synthesis. furthermore collagen synthesis is measured in muscle connective tissue and in skin. the hypothesis is that the connective tissue in ehlers-danlos patients is more compliant and poorer in collagen than healthy controls, but that collagen synthesis can be stimulated by igf-i.

igf-i will be injected with ultrasound guidance to one patella tendon and the other one will be injected with saline as control. injections will be performed double blinded and timed 24 hours and 6 hours before tissue sampling. collagen synthesis will be measured as fractional synthesis rate based on stabile isotope technique using labelled proline. 10 patients diagnosed with classical form of ehlers-danlos syndrome will be included and matched with 10 healthy controls based on age, gender, bmi and activity level. the muscle biopsy will be taken from vastus lateralis muscle and the skin biopsy from the buttocks. the biopsies will if the size permits it also be used for histology and mrna analyses.

Eligibility criteria:
inclusion criteria: * classic form of ehlers-danlos syndrome or healthy matched control exclusion criteria: * malignity, cardiac diseases, diabetes, tendinopathy in patella tendons

Keywords: col5a1 collagen disorders igf-i collagen synthesis
step teens weight maintenance: a research study on how well semaglutide helps teenagers with excess body weight to lose weight and maintain weight loss

Conditions: Obesity

Summary: the study is testing how well semaglutide can help adolescents with excess body weight to lose weight and to maintain weight loss. all participants in the study will receive semaglutide as a weekly injection. the study medicine is injected with a thin needle in the stomach, thighs or upper arms. all participants will get semaglutide treatment for a minimum of 3 years.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study: 1. the parent(s) or legally acceptable representative (lar) of the participant must sign and date the informed consent form, according to local requirements 2. the participant must sign and date the child assent form or provide oral assent, according to local requirements * age 12 to less than 15 years at the time of signing the informed consent * bmi greater than or equal to 95th percentile at screening * body weight greater than 60 kg at screening exclusion criteria: * prepubertal status (tanner stage 1) * treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening * previous or planned (during the study period) obesity treatment with surgery or a weight loss device. however, the following are allowed: 1. liposuction and/or abdominoplasty, if performed more than 1 year prior to screening 2. adjustable gastric banding, if the band has been removed more than 1 year prior to screening 3. intragastric balloon, if the balloon has been removed more than 1 year prior to screening 4. duodenal-jejunal bypass liner (e.g., endobarrier), if the sleeve has been removed more than 1 year prior to screening * endocrine, hypothalamic, or syndromic obesity * history of type 1 or type 2 diabetes mellitus
economic evaluation of an exercise program after multidisciplinary rehabilitation in patients with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the purpose of the study is to compare, after functional multidisciplinary rehabilitation for chronic low back pain, an exercise program to the routine follow-up which is simply to advice patients to exercise regularly at home. the exercise program should help patients stay active, which should translate into a better long term quality of life and decreased days off work.


Eligibility criteria:
inclusion criteria: * subacute or chronic low back pain * phases 2 to 6 of the krause classification * without irritative neurological deficit * age between 18 and 60 * having completed functional multidisciplinary rehabilitation exclusion criteria: * phases 7 and 8 of the krause classification * entitled to a total disability pension * acute neurological deficit in progress * sciatica * pregnancy * acute inflammatory rheumatic disease * non-osteoarticular thoracic pain * spinal fracture within the last 3 months * osteoporosis * tumor * severe heart failure or respiratory failure * active drug addiction * current involvement in litigation related to low back pain * active psychiatric pathology

Keywords: chronic low back pain multidisciplinary rehabilitation exercise cost-effectiveness
clinical performance of two daily disposable soft contact lenses

Conditions: Refractive Errors

Summary: the purpose of this study is to compare the clinical performance of precision1 contact lenses with biotrue contact lenses.

subjects will be expected to attend 3 visits. subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. the total duration of a subject's participation in the study will be up to 22 days.

Eligibility criteria:
key inclusion criteria: * successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. * willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed. * willing to wear contact lenses for at least 16 hours on the day prior to visit 2 and the day prior to visit 3. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. * habitual precision1, biotrue, and dailies total1 contact lens wear. * monovision and multifocal lens wear. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses
tolerability of device based therapies for neurofibromatosis type 1 cutaneous neurofibromas

Conditions: Cutaneous Neurofibroma

Summary: this study will evaluate the tolerability and effectiveness of three fda-approved treatments in neurofibromatosis type 1 cutaneous neurofibromas. these treatments are: a 1064nm laser, a 755nm laser, and a kybella injection. each patient will have a treatment and a control site.


Eligibility criteria:
inclusion criteria: * adult males and females ≥18 years of age * have a diagnosis of neurofibromatosis type 1 * patients must be seeking treatment for cutaneous neurofibromas * patients must have ≥ 6 paired cutaneous neurofibromas (3 to be treated and 3 untreated) that are visible and measure between 2-4mm in size. * able and willing to comply with all visit, treatment and evaluation schedules and requirements * able to understand and provide written informed consent * access to a smart phone to be able to take and upload photographs to an application exclusion criteria: * patients who are undergoing other treatment modalities or investigational agents for their cnf lesions * individuals who cannot give informed consent or adhere to study schedule * actively tanning during the course of the study * adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists; * known allergy to injectable anesthetics or deoxycholic acid * any condition which, in the investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study; * pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug.

Keywords: neurofibromatosis type 1
effectiveness of simulation with nursing students in the care of patients with sepsis

Conditions: Learning Process in Nursing Graduation; Stress

Summary: simulation is an active teaching strategy capable of reproducing real situations and allowing practical experiences, in which the student is the protagonist of his own knowledge. scientific evidence highlights, that exposure to the unknown or new can generate stress to the individual, but when dosed, to a certain extent it can increase the level of knowledge. not infrequently, the lack of stress control can trigger physiological and subjective changes resulting from the increase in its level, such as situations that include the implementation of simulation scenarios in pedagogical teaching models.

objective: to evaluate the effect of simulation (high and low fidelity) on the cognitive, physiological and emotional sphere of nursing students in caring for patients with signs of sepsis. hypothesis of the study: null hypothesis: students undergoing high-fidelity simulation will show similar levels of stress, cognitive performance and retention of knowledge in relation to those who will perform low-fidelity simulation in patients with signs of sepsis. alternative hypothesis: the cognitive performance and stress will be higher in students who experience high fidelity simulation when compared to students who experience low fidelity simulation.

Eligibility criteria:
inclusion criteria: * students approved in the discipline related to nursing care for adult and elderly patients; * aged over 18 years. exclusion criteria: * who have experience in the health field (firefighters and nursing technicians, among others); * members of the health simulation league; * those who do not complete all stages of the research.

Keywords: simulation stress, psychological nursing, education simulation training learning
an exploratory clinical trial to generate whole blood samples for analysing genetic polymorphisms

Conditions: Prediabetes; Diabetes Type 1; Diabetes Type 2

Summary: g (guanine nucleotide binding) proteins associating with g protein-coupled receptors (gpcr) are key players in the pathogenesis of obesity and diabetes and are targets of pharmacotherapeutic inter-ventions. in addition, g proteins binding to gpcrs either directly or permissively determine the efficacy of lifestyle interventions and drugs aiming at weight management and diabetes treatment. polymor-phisms of the fat mass and obesity-related protein (fto) gene have been also well characterised and linked to energy intake, body fat mass as well as cvd risk and the susceptibility to weight-reducing interventions. stratifying patients according to g protein and fto-related genotyping may enable a more accurate prediction of individual disease courses and responses to therapeutic interventions in terms of safety and tolerability as well as efficacy. although the objectives primarily refer to the analysis of g pro-tein and fto-related genotypes, also other genes of potential relevance for the evolution of obesity and/ or diabetes and the response to lifestyle and pharmacological interventions may be analysed.


Eligibility criteria:
inclusion criteria: general 1. informed consent obtained before any trial-related activities 2. males and females equal or more than 18 years old healthy volunteer-specific 3. considered generally healthy based on medical history and physical examination as per discretion of the investigator t2dm-specific 4. t2dm diagnosis prior to the start of trial examinations. t1dm-specific 5. t1dm diagnosed clinically prior to start of trial examinations exclusion criteria: general 1. mental incapacity or language barriers which preclude adequate understanding or cooperation, unwillingness to participate in the trial, known or suspected not to comply with trial directives or not to be reliable or trustworthy, or subjects who in the opinion of their general practitioner or the investigator should not participate in the trial. healthy volunteer-specific 2. previous diagnosis of any type of diabetes mellitus, e.g. t1dm, t2dm, gestational diabetes, maturity onset diabetes of the young, etc. t2dm-specific 3. t1dm, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acrome-galy or cushing's syndrome. t1dm-specific 4. t2dm, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acrome-galy or cushing's syndrome.