Kornimate/medical-research-clean huggingface dataset:
frailty and mortality in older old with severe aortic stenosis

Conditions: Aortic Stenosis

Summary: background.- the frailty syndrome (fs) associates an increase in morbidity and mortality in the elderly patient. when severe and symptomatic, aortic stenosis (as) is a disease with poor prognosis, the most frequent cause of heart surgery in the elderly and associates high health costs. no variables have been identified as determinants of morbidity and mortality of these patients and there are not algorithms developed for treatment decision-making in this particular population. the fs as a functional reserve indicator could be a prognostic and interventional treatment tolerance marker, and should be included in the selection of patients for surgical treatment. the fs and cardiovascular disease (cvd) share biological substrates among which an inflammatory state associates poor prognosis. objectives .- to evaluate the effectiveness of the diagnosis of fs to characterize the prognosis of elderly patients with severe symptomatic as representative of clinical practice. in addition, to examine the contribution of an inflammatory state to the relationship of fs with the prognosis of severe, symptomatic as. methods .- prospective study during 12 months of 200 patients \> 74 years old with severe symptomatic as. during the index visit the main clinical characteristics will be recorded and in addition we will perform a comprehensive geriatric assessment, fs assessmet according to fried et al criteria (strength, walking speed, physical activity, fatigue, unintentional weight loss) and determination of inflammatory markers (c-reactive protein and interleukin-6). during follow-up, measures of functional impairment (basic and instrumental activities of daily living, walking speed and timed set up \& go test), hospitalizations, death and quality of life will be determined.


Eligibility criteria:
inclusion criteria: * severe aortic stenosis * 75 years or older * ambulatory exclusion criteria: * life expectancy lower than one year * severe cognitive decline * previous intervention on aortic valve

Keywords: aortic stenosis, frailty, elderly, moertality
safety and tolerability study of depot buprenorphine in treatment seeking subjects with opioid use disorder

Conditions: Opioid Use Disorder; Opioid-related Disorders

Summary: a multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. following a screening period, all subjects will receive run in suboxone sublingual film followed by an initial injection of open-label high dose (300 mg) rbp-6000. the rbp-6000 monthly injection dose can be adjusted to low dose (100 mg), and back to high dose, based on the medical judgment of the investigator. subjects will participate in the study for either 6 or 12 months.

approximately 600 subjects diagnosed with opioid use disorder will be enrolled; approximately 300 subjects who completed the randomized,double-blind, placebo-controlled study nct02357901 (rb-us-13-0001) ('roll-over' participants), and approximately 300 subjects who did not participate in study rb-us-13-0001 ('de novo' participants). following informed consent and completion of screening procedures, all subjects will receive suboxone sublingual film, titrated to response. after 4-14 days of suboxone sublingual film treatment, subjects will be evaluated for enrollment into the study. eligible subjects will receive 300 mg rbp-6000 as an initial dose, followed by monthly injections of 100 mg or 300 mg rbp-6000, based on the medical judgment of the investigator. subjects who participated in study rb-us-13-0001 ('roll-over' participants) will receive monthly injections for up to 6 months. subjects who did not participate in study rb-us-13-0001 ('de novo' participants) will receive monthly injections for up to12 months. at all injection visits continuous electrocardiogram recordings and pulse oximetry will be collected prior to injection and at least 4 hours after injection. subjects will return to the clinic every 1-4 weeks for laboratory tests, complete study questionnaires, adverse event and injection site assessments.

Eligibility criteria:
inclusion criteria: de novo subjects: * seeking treatment for opioid use disorder (oud) and for the previous 3 months meet the diagnostic and statistical manual 5 (dsm-5) criteria for moderate or severe oud * appropriate candidate for opioid partial-agonist treatment * bmi between 18 and 35, inclusive roll-over subjects: * completed rb-us-13-0001 exclusion criteria: de novo subjects: * current diagnosis, other than oud, requiring chronic opioid treatment * current substance use disorder with regard to substances other than opioids, cocaine, cannabis, tobacco or alcohol * received medication-assisted treatment for oud in the 90 days prior to informed consent * use (within past 30 days prior to informed consent) or positive urine drug screen (uds) at screening for barbiturates, benzodiazepines,methadone or buprenorphine * treatment for oud required by court order * history of recent suicidal ideation or attempt roll over subjects: * experienced major protocol deviations or adverse events in rb-us-13-0001 which could potentially compromise subject safety * discontinued early from study rb-us-13-0001
cpx in paradoxical low flow aortic stenosis

Conditions: Aortic Valve Stenosis

Summary: severe aortic stenosis is a condition with poor life expectancy once it becomes symptomatic. there are no prospective studies illustrating the utility of cardiopulmonary stress (cpx) testing in diagnosing and prognosticating patients with paradoxically low gradient and low flow severe aortic stenosis. we aim to prospectively investigate the utility of cpx in this patient population with the hypothesis that utilizing cpx parameters would better identify higher risk patients warranting further evaluation and possibly intervention sooner.

this will be a prospective crossectional, longitudinal study recruiting patients by invitation with paradoxical low flow low gradient severe aortic stenosis. patients with plflg as will have been identified in other studies and these patients will be approached for enrollment in the study. patients deemed appropriate for enrollment will undergo recumbent bicycle stress testing with concomitant measure of gas exchange. the bicycle will be at 30 degrees with initiation of minimal resistance for 3 minutes, followed by an increase in work-rate of 25 watts every two minutes until the patient reaches a sign/symptom-limited maximum exertion or test limiting symptoms develop. charts will be reviewed for baseline medical conditions and demographics. cpx protocol will be standard hfh protocol supervised by exercise physiologist. the first phase of the study will be investigating if these asymptomatic patients will be reclassified to symptomatic as defined by reduced v02 max. the second phase will be following these patients for long term adverse events and if v02 max correlates with a higher risk.

Eligibility criteria:
inclusion criteria: * aortic valve area \<1 cm2 * mean aortic pressure gradient \<40 mmhg, * left ventricular ejection fraction \>50% by 2d transthoracic echocardiography exclusion criteria: * ischemic heart disease * severe mitral valve disease (regurgitation or stenosis) * moderate or severe aortic regurgitation * pulmonary hypertension (pa pressure \>50 mmhg) * copd * uncontrolled hypertension (systolic bp or diastolic bp greater than 150/90) * inability or unwillingness to exercise.
clinical impact of fast phenotypic antimicrobial susceptibility testing on patients with gram-negative rod bacteremia

Conditions: Gram-negative Bacteremia

Summary: the fda-cleared accelerate pheno™ system and phenotest™ blood culture (bc) kit will be used to assess the workflow impact of fast identification (id)/ antimicrobial susceptibility testing (ast) in the microbiology lab and in the quality of care in patients with gram-negative rod (gnr) bacteremia. blood culture work up will be randomized to one of two arms: the positive blood culture will either undergo fast id and ast using the accelerate pheno™ system and phenotest™ bc kit or processing per the site's standard of care (soc) procedures.


Eligibility criteria:
inclusion criteria: * adult (≥18 years of age) hospitalized patients with positive blood culture due to gram-negative rod (on gram stain) * blood culture drawn in the emergency department (ed) exclusion criteria: * patients not admitted to hospital * patients discharged from hospital prior to blood culture positivity * only the first positive blood culture for each patient of each hospitalization will be included during the study period; any subsequent episode of bloodstream infection (bsi) will be excluded * positive blood culture with gnr in the prior 7 days (if known at the time of randomization) * transferred from an outside hospital and had a history of a previously positive blood culture of the same organism in the prior 7 days (if known at the time of randomization) * gnr plus gram-positive organism, gram-negative cocci, and/or yeast detected on blood culture gram stain * deceased or palliative care at the time of randomization * patient who is moribund (does not survive the initial 72 hours after enrollment)
to evaluate the efficacy and safety in patients with dyslipidemia and hypertension

Conditions: Dyslipidemia; Hypertension

Summary: a multi-center, randomized, double-blind, parallel, phase iii clinical trial to evaluate the efficacy and safety of co-administration of jw0101+c2101 in patients with dyslipidemia and hypertension.

multicenter, randomized, double-blind, parallel-design, phase iii clinical study

Eligibility criteria:
inclusion criteria: * patients with hypertension and dyslipidemia exclusion criteria: * the subject not meet the specified msbp and ldl-c level
impact of plasma lipids on β cell function and insulin sensitivity

Conditions: Hypertriglyceridemia; Glucose Intolerance

Summary: the investigators aim to evaluate whether and to what extent glucose tolerance, beta cell function, insulin clearance, and glucose metabolic fluxes change in response to an acute increase in plasma triglycerides during lipid infusion, independently of free fatty acid (ffa) levels, in nondiabetic subjects.

mild hypertriglyceridemia is associated with reduced glucose tolerance and increased risk of type 2 diabetes, independent of obesity, in both cross-sectional and prospective studies. it is unclear whether this association is direct or mediated by circulating lipid substrates of triglycerides (free fatty acids, or ffa) and which are the mechanisms involved. to comprehensively examine the effects of mild acute hypertriglyceridemia on major glucose homeostatic mechanisms involved in diabetes progression, two dual-labeled oral glucose tolerance tests (ogtt) during 5-hour intravenous infusions of either 20% intralipid or normal saline will be performed in healthy lean volunteers. lipid-induced changes in glucose tolerance and insulin metabolism will be evaluated.

Eligibility criteria:
inclusion criteria: * age 18-65 years * body mass index (bmi) 18-35 kg/m2 * both women and men exclusion criteria: * chronic or acute diseases * any medications * pregnancy
effect of food-derived active components on digestive tract health in adults with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome - Diarrhoea

Summary: the goal of this clinical trial is to learn if bifidobacterium. animalis subsp. lactis a6 strain or resveratrol to improve the symptoms of diarrhea-predominate irritable bowel syndromes (ibs-d). the main questions it aims to answer are: 1. does bifidobacterium animalis subsp.lactis a6 strain or resveratrol improve the symptoms of ibs-d. 2. what is the optimal intervention dose of bifidobacterium. animalis subsp.lactis a6 strain or resveratrol to improve ibs-d researchers will compare bifidobacterium. animalis subsp.lactis a6 strain or resveratrol interventions to placebo (one look-alike sunbstance that contains no interventions substance) to see if bifidobacterium. animalis subsp.lactis a6 strain or resveratrol relief the symptoms of patients with ibs-d. participants will: 1. take bifidobacterium. animalis subsp.lactis a6 strain or resveratrol every day for 30 days. 2. visit the clinic once every 15 days for checkups and tests.

we recruited patients with ibs-d. the subjects who met the inclusion criteria were randomly divided into placebo control group, bifidobacterium. animalis subsp.lactis a6 strain group and resveratrol intervention. the intervention period lasted for 4 weeks, and the follow-up was conducted every 15 days. the main outcomes were: ① ibs symptom severity scale (ibs-sss), ② gut microbiota and their metabolites. the secondary outcomes were: ① ibs quality of life score (ibs-qol), ② bristol fecal traits score, ③hydrogen breath test; ④ inflammatory markers. after the intervention, statistical analysis was performed on the experimental data to analyze and compare the differences in the main and secondary outcome indicators of the experimental groups, so as to clarify the intervention effect and effective intervention dose of probiotics and resveratrol on diarrheal ibs, and provide scientific basis for the formulation of relevant clinical treatment paths.

Eligibility criteria:
inclusion criteria: * met the western medicine rome iv diagnostic criteria for diarrheal ibs * 18 and 60 years old * subjects voluntarily sign informed consent forms. exclusion criteria: * having a disease that may affect the gut microbiome (e.g., inflammatory bowel disease, celiac disease, diabetes) * abdominal pain or diarrhea due to organic disease * patients with abdominal surgery * patients with serious mental illness and complications of heart, brain, liver, kidney and other systems * unable to communicate normally or skilled in the use of communication equipment * having serious mental problems or taking related drugs * drug or alcohol abusers * people with special diets (such as vegetarians) or eating disorders or are receiving therapeutic dietary interventions * had used antibiotics, probiotics, other drugs that may affect the study * participants who are participating in other clinical trials * pregnant or lactating women

Keywords: diarrhea-predominate irritable bowel syndrome probiotics polyphenols
safety of fentanyl taifun treatment

Conditions: Breakthrough Cancer Pain

Summary: a multicenter, multinational, randomized, open-label, parallel-group trial to evaluate hte safety of fentanyl taifun treatment after titrated dose administration and the current breakthrough pain treatment for breakthrough pain in cancer patients on maintenance opioid therapy


Eligibility criteria:
inclusion criteria: * age 18 years or older * a medically documented diagnosis of cancer * use of a fixed round the clock dose of opioid as maintenance therapy with a dose equivalence of at least 60mg of oral morphine/ day, or at least 25 mcg of transdermal fentanyl/ hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily. current opioid treatment for at least 7 days prior to randomization * current use of opioid medication for btp * at least 4 episodes of btp per week, with peak intensity of at least 4 on the nps at pain onset. no more than 4 btp episodes per day. * pifr of at least 20l/min * karofsky performance status of 40 or better * life expectancy of at least 12 weeks * written informed consent exclusion criteria: * uncontrolled or rapidly increasing btp * symptomatic intracranial tumors or cerebral metastases * persistent symptomatic asthma * patients unable to use the inhaler * inadequate lung function, as defined by pefr \<60% * hypersensitivities, allergies or contraindications to fentanyl or the study medication components * a recent history of alcohol or substance abuse (in the past 1 year) * radiotherapy to the thorax within 30 days of the beginning of the titration phase * cognitive impairment or any neurological of psychiatric disease which could compromise the ability of the patient to complete the assessments * participation in any clinical study with an experimental drug within 30 days of randomization * any clinical condition or medical history which, in the opinion of the investigator would not allow for the safe completion of the study or the safe administration of the study drug * pre-menopausal women who are not surgically sterile and/or have a positive pregnancy test at baseline visit and/ or are of child bearing potential and are not using a reliable method of birth control or do not plan to continue using this method throughout the study and/or who are nursing

Keywords: pain
physical activity and screen-time regulations in childcare centers - aim 2

Conditions: Childhood Obesity

Summary: objective is to examine the physical activity and screen-time behaviors of children enrolled in licensed childcare centers before and after the enactment of new state regulations.

pause and play aims to enroll 266 children. each child will participate in the study for approximately 1 year. surveys, anthropometric measures, and screen-time observations will take approximately 1 day each to complete, and the child will be given an accelerometer to wear at home for 7 days at both baseline and 1 year follow-up. fundamental motor skill assessments will take place at baseline and 1 year follow-up after the 7 days of accelerometer wear. staff members will spend approximately 2 weeks at each childcare center at baseline and 1 year follow-up to complete study procedures with each child.

Eligibility criteria:
inclusion criteria: * a child who is 3 or 4 years old * child spends at least 6 hours per day, 5 days per week at a participating childcare center * child will continue to attend the same childcare center for the next year exclusion criteria: * parent/legal guardian is unwilling to provide written informed consent

Keywords: childcare center regulations physical activity sedentary behavior screen-time behavior
npd measurements in psc patients

Conditions: Primary Sclerosing Cholangitis

Summary: primary sclerosing cholangitis (psc) is a chronic disorder of the liver causing jaundice and liver damage. when cystic fibrosis affects the liver, the damaged liver looks like the liver in psc. this study is designed to answer the question whether isolated psc may be a form of cf only in the liver

cystic fibrosis (cf) is a progressive autosomal recessive disorder caused by defects in the cystic fibrosis transmembrane conductance regulator gene (cftr). cftr mutations cause loss or impairment of cftr-mediated ion transport across epithelial cell membranes. cf affects many organs including the respiratory tract, pancreas, intestine, liver and the male reproductive tract. liver disease occurs less frequently than pulmonary disease. cftr is expressed in the bile duct epithelial cells and is responsible for the hydration of biliary secretions. cf was until recently, thought to be a multi-organ disease. however, there are now recognized non-classical presentations of cf involving a few organs only and now there is well established data on single -organ involvement including congenital absence of the vas deferens and recurrent pancreatitis. cf and psc have several features in common. they both affect intrahepatic bile ducts by inspisated biliary secretions, chronic inflammation and fibrosis. is psc the "single-organ presentation" of cf? patients with psc will undergo testing of the cf protein channel by nasal potential testing. this test is performed by insering a thin plastic tube 2 to 3 cms into the nostril and chloride transport can be measured. this test may shows that the patient has an abnormality in the cf protein channel.

Eligibility criteria:
inclusion criteria: * age \> 10 years * patients diagnosed as non-ibd psc * patients diagnosed as ibd psc exclusion criteria: * age \< 10 years

Keywords: cystic fibrosis, nasal potential difference, primary sclerosing cholangitis
the psoteenqol - preliminary reliability and validity

Conditions: Psoriasis

Summary: this study aims to develop and provide preliminary reliability and validity of a questionnaire to measure health-related quality of life (hrqol) in adolescents with psoriasis. to the best of our knowledge, this will be the first psoriasis-specific hrqol instrument for use in adolescent patients. data will be collected from a danish population of adolescents with psoriasis (12-17 years), as well as from parents of adolescents with psoriasis, and a group of adolescents without psoriasis.

the present study will examine the psychometric properties of a preliminary 41-item version of the psoteenqol. the preliminary psoteenqol has been developed based on qualitative interviews of adolescents (12-17 years) with psoriasis, their parents, and health professionals working within the field, as well as literature reviews and existing questionnaires. face and content validity has been established through subsequent cognitive interviews with the target group. exploratory factor analysis (efa) and analysis of differential item functioning (dif) will be used to further refine the psoteenqol questionnaire by selecting the most appropriate items. in addition, indicators of reliability (internal consistency; test-retest reliability), validity (construct validity, criterion validity; discriminant validity), and responsiveness will be evaluated.

Eligibility criteria:
inclusion criteria: * either a) subjects with psoriasis, b) parents of adolescents 12-17 years with psoriasis, or c) subjects without psoriasis * ability to read danish and complete electronic survey exclusion criteria: * inability to read danish and complete electronic survey

Keywords: psoriasis, adolescents, quality of life, pro (patient-reported outcome), validation
brace efficiency and generalized joint hypermobility

Conditions: Scoliosis Idiopathic; Hypermobility, Joint

Summary: the goal of this observational study is to learn about effect of generalised joint hypermobility on the effectiveness of the brace in children with adolesan idiopatic scoliosis and who use braces due to brace indication. the main questions it aims to answer are: * does generalized joint hypermobility have an effect on the amount of in-brace improvement achieved in children using braces? * does generalized joint hypermobility have an effect on the change in the numerical variables related to scoliosis recorded in the out-brace measurement at the end of 6 months?


Eligibility criteria:
inclusion criteria: * being under brace treatment due to the diagnosis of adolescent idiopathic scoliosis. * having a standing posterior-anterior radiograph before and during the brace use. * having a curve of 20 degree and above according to the cobb angle. * confirmation of participation. exclusion criteria: • having systemic diseases related to gjh (ehlers-danlos, down, marfan, larsen).