Kornimate/medical-research-clean huggingface dataset:
comparison of the severity of agitation of sugammadex and atropine-nesostigmine in adenotonsillectomy

Conditions: The Severity of Agitation in Adenotonsillectomy in Pediatric Patients

Summary: the use of sugammadex during the reversal of neuromuscular blocking after adenotonsillectomy surgery in pediatric patients would be advantageous in terms of patient comfort and reducing side effects. thus, we aimed to evaluate the time to extubation, agitation and pain scores in pediatric patients who underwent adenotonsillectomy and awakened with neostigmine and sugammadex in our study.

a total of 70 patients in the american society of anesthesiologists (asa) i-ii risk group, aged 5-13 years, who will be undergoing adenotonsillectomy with recurrent / chronic tonsillitis or obstructive sleep apnea in the otorhinolaryngology clinic of our hospital were included. investigator did not assign specific interventions to the study participants. patients were selected to sugammadex + saline group (group s) and neostigmin+atropine group (group n) and 35 patients were seleceted for each group randomly. patients receive interventions as part of routine medical care, and a researcher studies the effect of the intervention. tracheal extubation time (from discontinuing anesthetics until extubation), duration of anesthesia (from the injection of anesthetic until discontinuation) duration of the operation (from the injection of anesthetic until until the patient's discharge from the operating room) were recorded for each patient. we assessed the agitation level with the pediatric anesthesia emergence delirium (paed), which provides a score from 0 to 20, at first 15 minutes (t0), 1st (t1), 4th (t4), 8th (t8) and 12th (t12) hours post-extubation

Eligibility criteria:
inclusion criteria: * patient who will be undergoing adenotonsillectomy with recurrent / chronic tonsillitis or obstructive sleep apnea in the otorhinolaryngology clinic * american society of anesthesiologists (asa) i-ii risk group, * aged 5-13 years, exclusion criteria: * patients with history of allergy to any medication used during general anesthesia, * known or suspected neuromuscular disorders that impair neuromuscular blockade, * liver and kidney disease, * asthma, * bleeding diathesis. * written and verbal consents were obtained from the legal guardians of the patients who are blınded of the groups to participate in the study.

Keywords: adenotonsillectomy severity of agitation sugammadex
mobile phone-based motivational interviewing in kenya

Conditions: Alcohol Use Disorder

Summary: the primary objective of this study was to test whether motivational interviewing (mi) provided over the mobile phone would reduce alcohol use among adults, including people living with hiv/aids, visiting primary care in kenya. heavy alcohol users voluntarily consented to being randomized to one of three study arms: standard in-person mi, mobile mi, or waitlist control receiving no intervention for 1 month followed by mobile mi. alcohol use problems were assessed using validated screeners and changes in alcohol use were assessed at 1 month and 6 months after receiving the intervention. the investigators hypothesized that alcohol use would reduce after mi treatment compared to waitlist control, there would be no difference between standard in-person mi and mobile mi, and these reductions would be sustained out to six months following the intervention.


Eligibility criteria:
inclusion criteria: * adults visiting the primary care clinic and screening positive for potential alcohol use problems. exclusion criteria: * persons younger than 18 years old, with severe psychiatric morbidity, or cognitive impairment were not eligible for the study
safety and efficacy of bimatoprost/timolol fixed combination versus latanoprost in patients with open-angle glaucoma who have never been treated

Conditions: Glaucoma, Open-Angle

Summary: this study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (ganfort®) versus latanoprost (xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.


Eligibility criteria:
inclusion criteria: * diagnosis of primary open-angle glaucoma that has never been treated * visual acuity 20/60 or better in each eye exclusion criteria: * eye surgery within 3 months * any refractive eye surgery * contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease \[copd\], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction \[heart attack\]) * eye inflammation or eye infection within 3 months * eye trauma within 6 months * oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study
effect of simethicone on postoperative ileus in patients undergoing colorectal surgery

Conditions: Postoperative Ileus; Ileus

Summary: post-operative ileus is a common complication following abdominal surgery. it results in abdominal distension, nausea and vomiting as well as abdominal pain. furthermore, this results in prolonged hospital stay and occasionally readmission following abdominal surgery.the etiology of post-operative ileus is multifactorial and studies evaluating potential treatment options are abundant, though few reliable interventions exist. this study proposal describes a double-blinded randomized controlled trial investigating the effect of simethicone on post-operative ileus in patients undergoing colorectal surgery.

simethicone is an orally administered anti-foaming agent comprised of polydimethylsiloxane and hydrated silica gel. its leads to the coalescence of gas bubbles in the intestinal tract, facilitating its emission. to date, there are no contemporary studies evaluating the efficacy of simethicone on poi in patients undergoing colorectal surgery. the proposed study is a pilot double-blinded randomized controlled trial of simethicone versus placebo in patients undergoing colorectal surgery. starting on postoperative day one, patients in the experimental arm of the study will receive, in a blinded fashion, 160mg of simethicone orally four times a day for the first five postoperative days. patients assigned to the control arm will receive a placebo agent orally with the same frequency and duration. all consenting patients over the age of 18 undergoing elective, abdominal colorectal surgery involving bowel resection with or without re-anastomosis at either the juravinski hospital and cancer center or st. joseph's hospital in hamilton, ontario will be enrolled. this will include patients undergoing both open and laparoscopic surgery. patients will be prospectively evaluated by a trained research assistant on a daily basis while in hospital. passage of flatus, bowel movements, and postoperative pain will be evaluated at those visits. a two-week, and 30-day phone call to patients discharged from hospital will be done to assess for outcomes after discharge. follow-up will end after the 30th postoperative day.

Eligibility criteria:
inclusion criteria: * all consenting patients over the age of 18 undergoing elective, abdominal colorectal surgery involving bowel resection with or without re-anastomosis (both open and laparoscopic surgeries) at either the juravinski hospital and cancer center or st. joseph's hospital in hamilton exclusion criteria: * patients undergoing emergency surgery * documented allergy to simethicone * unable to provide informed consent (non-english speaking patients and those with cognitive impairment) * patients not having an abdominal operation (ie. perineal procedure)

Keywords: colorectal surgery postoperative ileus simethicone randomized controlled trial double blind pilot study anti-foaming agent abdominal pain abdominal distention nausea vomiting flatus bowel movement placebo postoperative complications polydimethylsiloxane hydrated silica gel gas bubbles intestinal tract
safety and efficacy study of ceftaroline versus a comparator in pediatric subjects with complicated skin infections

Conditions: Infections, Pediatrics

Summary: this is a study of safety, effectiveness, blood levels and tolerance of ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.

to evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in children who are initially hospitalized with acute bacterial skin and skin structure infections (absssi).

Eligibility criteria:
inclusion criteria: * male or female, 2 months to \< 18 years old. * presence of absssi warranting initial hospitalization. * presence of absssi with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervention exclusion criteria: * documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial * uncomplicated skin and soft tissue infections * more than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization. * requirement for any concomitant systemic antimicrobial therapy * history of seizures, excluding well-documented febrile seizure of childhood. * clinical signs or suspicion of meningitis

Keywords: infections pediatrics teflaro cephalosporin
remote monitoring of axial spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: the remonit study is a 18-months, non-inferiority randomized, controlled trial with three parallel arms to determine if two, new follow-up strategies for patients with axial spondyloarthritis (axspa) are non-inferior in maintaining stable, low disease activity over time compared to the conventional follow-up regimen with regular hospital visits.

the trial will include norwegian adult males and females with axial spondyloarthritis. 240 participants will be randomized 1:1:1 to either: 1. control group: a. usual care, i.e. conventional follow-up strategy with blood tests, patient-reported outcomes (pros), and pre-scheduled visits at the hospital every 6th month 2. remote monitoring: hospital health professionals (hps) perform remote monitoring of frequent pros, blood test results, and physical activity data available on a digital platform 3. patient-initiated care: no pre-scheduled visits or remote monitoring the study has 18 months follow-up. we will use a 15% non-inferiority margin. the study will also include qualitative research including semi-structured interviews and observations of patients in the two intervention groups and health professionals involved in the study. the interviews will explore experiences with remote monitoring and video consultations.

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-nursing female \>18 years of age at screening * patients with a diagnosis of axspa who fulfil the diagnostic assessment of spondyloarthritis international society (asas) criteria for axspa * stable medical treatment with tnfi the last 6 months * low disease activity (asdas\<2.1) at inclusion * capable of understanding the norwegian language and of signing an informed consent form exclusion criteria: medical conditions: * major co-morbidities, such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (nyha class iii or iv), severe respiratory diseases, and/or cirrhosis. * indications of active tuberculosis (tb) diagnostic assessments: * abnormal renal function, defined as serum creatinine \>142 µmol/l in female and \>168 µmol/l in male, or glomerular filtration rate (gfr) \<40 ml/min/1.73 m2 * abnormal liver function (defined as alanine transaminase (alt) \>3x upper normal limit), active or recent hepatitis * leukopenia and/or thrombocytopenia other: * pregnancy and/or breastfeeding (current at screening or planned within the duration of the study) * severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible

Keywords: rheumatic diseases musculoskeletal diseases joint diseases arthritis
the effect of aerobic exercise on an elliptical trainer versus a treadmill, in people with multiple sclerosis

Conditions: Multiple Sclerosis (MS)

Summary: the aim of this study is to examine the effects of aerobic exercise training using an elliptical trainer compared to a treadmill on gait and walking abilities, expressed in dynamic stability, balance, and walking speed, in people with multiple sclerosis with moderate severity.

a total of 30 ms subjects to be enrolled in the study. subjects to be assigned into one of two groups named: group 1 - elliptical training and group 2 - treadmill training. effort capacity will measured by heart rate and rpe. outcome measures will be measured by using, 6 min. walking test (6mwt), timed up \& go (tug), berg balance scale (bbs) and 10 meter walk test (10mwt) to be used to assess the quality of life at baseline (t0), during study - 6 weeks from baseline (t1), end of training program - 12 weeks from baseline (t2) and 6 weeks post t2 (t3). the exercise program to be applied for 12 weeks with 2 trainings per week.

Eligibility criteria:
inclusion criteria: 1. patients signed informed consent form 2. at least 6 months post ms diagnosis 3. 25-55 years old adults 4. edss 3.0-6.5 5. standing stability - for at least 30 seconds 6. 6mwt - minimal distance to be measured as 210 meters 7. no physical routinely training e.g. walking, elliptical or cycling within 3 months prior screening visit. exclusion criteria: 1. active heart disease 2. lungs and/or respiratory system diseases 3. metabolic disease 4. any other medical condition(s) which might impact the patient's participant in the study, as per pi medical judgement 5. major medical treatment change (as per pi medical judgement) up to 12 weeks prior icf signature by the patient.

Keywords: aerobic exercise elliptical trainer treadmill 6 minute walk test (6mwt) timed up & go (tug) berg balance scale (bbs) 10 meter walk test (10mwt) informed consent form (icf)
preventive sexual health screening among female-to-male (ftm) transgender adult patients

Conditions: Uterine Cervical Neoplasms; Sexually Transmitted Diseases

Summary: the purpose of this study is to assess the acceptability and effectiveness of utilizing vaginal self-swabs for hpv dna testing as compared to provider-collected cervical swabs for hpv, as well as to investigate the prevalence of other sexually transmitted infections (stis) among sexually active female-to-male (ftm) transgender adults.

this observational study will examine sexual health in a bio-behavioral cross-sectional mixed-methods design among 150 ftm patients in boston, massachusetts, and will determine the acceptability as well as collect epidemiologic data on the comparative performance characteristics of several biological screening modalities in this patient population. patients and stakeholders are key partners throughout the project and are involved in all phases of study development, implementation, and plans for dissemination. eligible participants will participate in a one-time clinical visit. following written consent, the one-time clinical visit will include: 1) quantitative assessment; 2) collection of biological specimens/biomarkers (hpv dna vaginal self-swab, hpv dna cervical swab collected by provider, pap test with cytology, sti testing self- and provider-collected); 3) qualitative interview. a series of national, online focus groups with ftms, providers, and key stakeholders will occur to gather information on the sexual health needs of ftm individuals outside the boston area and to ensure that the dissemination of study findings take differing demographic concerns into consideration.

Eligibility criteria:
inclusion criteria: * age 21-64 * assigned a female sex at birth and now self-identifies as a man, trans masculine, trans man, ftm, transgender, genderqueer/non-binary, transsexual, male, and/or another diverse transgender identity or expression * have a cervix * sexually active in the past 36 months (with sexual partner(s) of any gender) * able to speak and understand english * willing and able to provide informed consent exclusion criteria: * unable to provide informed consent due to severe mental or physical illness * substance intoxication at the time of interview

Keywords: transgender female-to-male cervical cancer hpv sexual health
fructose effect on neuroinflammation and feelings

Conditions: Gastro-Intestinal Disorder

Summary: fructose is increasingly present in our food. the increase in its consumption is associated with the increase in the prevalence of several pathologies such as metabolic syndrome or hepatic steatosis. the effect of fructose consumption on brain health has been poorly studied. studies in animal models show that diets enriched in fructose promote the development of emotional behavior disorders. fructose malabsorption is also associated with changes in the microbiota that could also impact brain health. however, no human study to date has associated fructose malabsorption with changes in the gut microbiota and effects on brain health. the objective of this study is to study the emotional behavior of a population of healthy volunteers according to the presence or not of fructose malabsorption. patients with fructose malabsorption are susceptible to gut dysbiosis without necessarily consuming high amounts of fructose.


Eligibility criteria:
inclusion criteria: * healthy volunteers * aged 18 to 35 * male sex * bmi between 18.5 and 25 * affiliation to a social security scheme * adult patient having read and understood the information letter and signed the consent form exclusion criteria: * presence of irritable bowel syndrome, celiac disease * presence of a psychiatric illness * presence of a neurodegenerative disease * presence of an eating disorder * presence of chronic disease, including inflammatory disease * presence of diabetes * presence of an acute infectious disease * presence of a surgical history of the digestive tract (excluding appendectomy) * taking long-term treatment * taking antibiotics within 6 months * taking probiotics within 3 months * typical diet low in lactose, fodmap, gluten, vegetarian, vegan, vegan, chromonutrition .... in progress * smoker * person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / under guardianship or guardianship * simultaneous participation in another interventional clinical trial
post treatment comparison intramedullary nail vs. nonoperative treatment

Conditions: Fracture of Clavicle

Summary: the objective of this post-market clinical study is to compare one to three year post treatment results, range of motion, strength, patient related functional outcomes and patient satisfaction, of internal fixation using the sonoma orthopedic products crx™ as compared to nonoperative management (e.g. sling) of similar displaced midshaft clavicle fractures.


Eligibility criteria:
inclusion criteria: * a displaced transverse or oblique midshaft clavicle fracture with or without comminution * must be 12 ± 2 months to 36 ± 2 months post-treatment * must have received nonoperative treatment or operative treatment with a crx™ device, no other devices, for their clavicle fracture * male or female at least 18 years of age * able to understand the requirements of the study, provide a written informed consent and comply with the study protocol * ability to understand and provide written authorization for use and disclosure of personal health information exclusion criteria: * open, or segmental clavicle fracture * any clavicle or upper extremity fracture previous, concurrent, or subsequent to the study fracture * removal of the crx™ device within 8 weeks of the study visit * history of alcoholism * currently on chemotherapy or radiation therapy * habitual use of narcotic pain medications prior to injury or after injury for reasons other than clavicle pain * currently on worker's compensation * history of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis * rheumatoid arthritis or other inflammatory arthropathies. * history of chronic pain issues for reasons other than clavicle pain or psychiatric disorder that precludes reliable follow-up. * women that are pregnant or think that they might be pregnant

Keywords: midshaft clavicle fracture intramedullary nail sling
csf analysis in egfr mutant non-small cell lung cancer with leptomeningeal disease

Conditions: EGFR Activating Mutation; Leptomeningeal Metastasis; Non Small Cell Lung Cancer

Summary: leptomeningeal disease is malignant seeding of the leptomeninges and presents with a variety of symptoms frequently impacting quality of life. with improvement in treatment options, rates of leptomeningeal disease are increasing and currently found in up to 9% of egfr mutant nsclc. systemic therapy may be more effective if it can target the correct molecular aberration. the molecular characterization of central nervous system disease may differ from disease outside of the central nervous system. the aim of this pilot trial is to evaluate for molecular differences between cerebral spinal fluid (csf) and blood circulating tumor dna (ctdna) through the use of ddpcr and bc cancer ngs panel molecular testing.

the aim of this pilot trial is to evaluate the concordance/discordance of molecular profiling of csf and plasma ctdna after the development of leptomeningeal disease in egfr mutant nsclc. patients with egfr mutant nsclc who develop leptomeningeal disease on a first, second or third generation tyrosine kinase inhibitor are potentially eligible for this clinical trial. this is a prospective pilot study designed to accrue 10 patients. baseline mri brain and spine must be completed prior to enrolment to insure that a lumbar puncture can be completed safely. all eligible subjects will be consented for ddpcr and canexia follow it plasma and csf based molecular testing. patients will have baseline information collected and will complete baseline quality of life (qol) questionnaires. qol questionnaires will be obtained every 12 weeks +/- 2 weeks and survival will be measured through chart review. there will be no treatment intervention; however we will collect information on treatment received after enrolment in trial. volume of leptomeningeal disease will be scored by number of gadolinium enhancing sites in 8 predetermined locations.

Eligibility criteria:
inclusion criteria: * subject age is greater than or equal to 18 years at the time of signature of informed consent. * histologically or cytologically confirmed metastatic egfr mutant nsclc. * leptomeningeal disease based on brain mri or csf cytology. * ecog 0-3. * life expectancy of at least 8 weeks. * adequate hematologic and end organ function for testing. * ability to give informed consent for the study procedures defined in this protocol. exclusion criteria: * inability to undergo a lumbar puncture due to thrombocytopenia, bleeding disorders, as well as inability to cooperate or consent to procedure. * subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol. * mri spine demonstrating spinal leptomeningeal disease preventing a safe lumbar puncture.

Keywords: non-small cell lung cancer egfr leptomeningeal disease