Kornimate/medical-research-clean huggingface dataset:
prevalence, incidence and characteristics of nafld/nash in type 1 diabetes mellitus

Conditions: NAFLD; Type 1 Diabetes; Cardiovascular Diseases

Summary: nonalcoholic fatty liver disease (nafld) is a condition characterized by intrahepatic fat accumulation. it is closely related to insulin resistance. to date, it remains unclear whether nafld is common in patients with type 1 diabetes or if nafld translates into an increased health burden in this population. screening for nafld is challenging due to the limitations of non-invasive diagnostic tools. liver biopsy remains the gold standard but is not suited for routine screening or clinical studies. therefore, there is a great demand for accurate non-invasive screening tools that can not only diagnose but also stage nafld. this study aims to generate a large cohort of thoroughly characterized type 1 diabetes patients screened for nafld using multiple non-invasive tools including mri, ultrasound, controlled attenuation parameter, and score panels. we aim to generate a biobank to promote a research collaboration network in the field of non-invasive diagnosis of nafld. a secondary endpoint is to investigate the potential correlation between the presence of nafld and the occurrence of micro-or macrovascular complications in patients with diabetes.

this study aims to characterize and follow a thoroughly characterized cohort of adult type 1 diabetes patients free from secondary liver disease due to excessive alcohol usage, viral hepatitis, alfa-1 antitrypsin deficiency, wilson's disease or steatogenic or hepatotoxic drug use. the investigators will screen for nafld and fibrosis using multiple non-invasive techniques including * ultrasound * controlled attenuation parameter * fatty liver index * human steatosis index * transient elastography * fib-4 * nafld fibrosis score * nash algorithm based on multiple parameters subjects will be screened for microvascular and microvascular complications with: * ecg * microfilament examination * 24hour urine collection for microalbuminuria * serum kidney test (creatinine, egfr) * fundoscopy * peripheral arterial pulsation palpation the investigators will subsequently thoroughly characterize various metabolic and anthropometric parameters and document any microvascular or macrovascular complications. the patients will be annually rescreened for both nafld-related as cardiovascular variables. therefore this study will assess the correlation between nafld, cardiovascular risk, and type 1 diabetes in a prospective manner.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * adult age * informed consent given exclusion criteria: * secondary liver disease * excess alcohol usage * pregnancy * use of steatogenic medication * active cancer or oncological treatment * history of organ transplantation

Keywords: nafld type 1 diabetes cardiovascular disease insulin resistance
bariatric surgery vs. lifestyle modification for nash

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: randomized controlled trial comparing the effects of bariatric surgery vs. lifestyle modification on nash resolution.

patients with biopsy-proven nash will be randomized to either bariatric surgery or lifestyle interventions. after 1-year follow-up a liver biopsy will be done to evaluate nash resolution

Eligibility criteria:
inclusion criteria: * bmi between 30 and 45 * with biopsy-proven nash * with or without type 2 diabetes * that fit for bariatric surgery. exclusion criteria: * borderline nash ou cirrhosis; * alcohol consumption (\> 20 g/day for men and \> 10 g/day for women, for the last 2 years); * other hepatic diseases (such as viral hepatitis, autoimmune hepatitis, drug-induced hepatic disease, wilson's disease, hemochromatosis); * hiv infection; * unable to provide informed consent; * previous foregut or bariatric surgery; * malignancy; * patients that unfit for bariatric surgery.
national survey of young adult nutrition

Conditions: Overweight or Obesity

Summary: the purpose of this research is to better understand how people's background, habits, and other factors influence their diets and health.

the purpose of this study is to provide further insight into the correlates and predictors of young adults' eating habits, with particular emphasis on sociodemographics, reproductive health, and food upbringing.

Eligibility criteria:
inclusion criteria: * u.s. citizens * current, full-time, non-institutionalized residents of the united states * access to a computer with internet access exclusion criteria: * non-u.s. citizens * non-resident of the united states * no access to a computer with internet access

Keywords: healthy weight
an observational study to evaluate impact of crp-level on real world effectiveness of upadacitinib as monotherapy or in combination with mtx in adult participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis (RA)

Summary: rheumatoid arthritis (ra) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. ra can reduce the ability to perform everyday tasks. this study assesses whether c-reactive protein (crp)-level has an impact on achieving remission with upadacitinib when used alone or in combination with methotrexate (mtx). this study will also assess the reduction in pain, morning stiffness, fatigue, functionality, health status and impact of ra. crp is an indicator of inflammation and often used for disease activity monitoring during ra treatment. upadacitinib is a janus kinase (jak) inhibitor indicated for the treatment of adults with moderately to severely active ra who have had an inadequate response or intolerance to methotrexate. this study has two groups - upadacitinib monotherapy and combination. adult participants with moderate to severe ra will be enrolled. around 500 participants will be enrolled in the study in multiple sites within germany. participants will receive upadacitinib alone or in combination with mtx per their physicians' usual prescription. individual data will be collected for 12 months. no additional study-related tests will be conducted during the routine physician visits. only data which are routinely collected during a regular visit will be utilized for this study.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe active rheumatoid arthritis (ra) upon judgment of the treating physician. * swollen joint count (sjc) \>= 3 of 28 joints of the disease activity score (das)28. * measurement of c-reactive protein (crp)-level at baseline (bl) or \<= 4 weeks prior to bl at a timepoint when the prednisolone equivalent dose of glucocorticoid treatment was \<= 10 mg/day for at least 7 days. * upadacitinib treatment is indicated as per local summary of product characteristics (smpc). * decision on the treatment with upadacitinib was made prior to any decision to approach the patient to participate in this study. exclusion criteria: * participants who cannot be treated with upadacitinib according to the local upadacitinib smpc. * prior treatment with upadacitinib. * treatment with sarilumab or tocilizumab within the last 8 weeks before the crp level for inclusion was measured. * participants currently participating in interventional research. * participants who are unwilling or unable to complete the patient reported questionnaires.

Keywords: rheumatoid arthritis (ra) upadacitinib rinvoq methotrexate (mtx) abt-494 c-reactive protein (crp)
reducing anxiety in pediatric dental patients through passive music therapy

Conditions: Anxiety, Dental

Summary: the purpose of this study is to determine if passive music listening decreases anxiety in patients undergoing dental procedures and if the effects of music therapy are influenced by gender, age, and amount or type of dental treatment needed.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status classification system i (asa i) i and american society of anesthesiologists physical status classification system ii (asa ii) * patient needs restorative procedure (with or without local anesthesia or nitrous oxide) * received previous dental restorative treatment (detected via visual or radiographic evidence of previous restoration - no additional radiographs will be exposed for this study; exposed radiographs will be previously obtained, as needed,for comprehensive or periodic dental reasons) exclusion criteria: * patients with hearing impairments * uncooperative patients at examination appointment (detected by frankl behavior score of 1 or 2)

Keywords: dental anxiety pediatric dentistry
organ failure after advanced endovascular thoracoabdominal aortic surgery

Conditions: Aortic Aneurysm; Spinal Ischaemia; Gastrointestinal Ischaemia

Summary: the purpose of this study is to investigate the mortality and frequency of organ dysfunction in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal tract. all adult patients undergoing endovascular thoracoabdominal aortic surgery at örebro university hospital, örebro, sweden, are asked for participation in this study. all participating patients sign informed consent at the inclusion. during the operation and during the postoperative intensive care, the function of the spinal cord, the gastrointestinal tract and the kidneys are collected along with other clinical parameters. plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each patient during the operation and during the postoperative care at the intensive care unit. during the operation two microdialysis catheters are placed in the abdomen, and the samples are continuously collected and analyzed. the biomaterial samples are stored in a biobank for later determination of proteins and other molecules. postoperative survival and the frequency of complications are analysed.


Eligibility criteria:
inclusion criteria: * accepted for endovascular advanced thoracoabdominal aortic surgical procedure * adult exclusion criteria: * pregnant
a study to evaluate nivolumab in the treatment of early stage esophageal or gastroesophageal cancer

Conditions: Esophageal Carcinoma; Gastroesophageal Junction Carcinoma

Summary: the purpose of this study is to describe the effectiveness and use of nivolumab after surgery in participants with early stage (stage ii/iii) esophageal cancer/gastroesophageal junction cancer (ec/gejc).


Eligibility criteria:
inclusion criteria: 1. must provide voluntary informed consent to participate in the study before inclusion in the study 2. must have confirmed diagnosis of resected early stage (stage ii/iii) ec or gejc (histologically or cytologically confirmed stage) 3. physician decision to treat the participant with adjuvant nivolumab (according to the local label as per country-specific regulations) must be made prior to and independently of participation in the study exclusion criteria: 1. participation in a clinical trial of an investigational drug, concurrently or within the last 30 days (participants who have completed their participation in an interventional trial and who are only followed-up for os can be enrolled.) 2. prior treatment with immuno-oncologic agents, including nivolumab, for any indication 3. participants with a current primary diagnosis of a cancer other than ec or gejc that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)

Keywords: nivolumab adjuvant post marketing non-interventional
acceptance and commitment therapy and exercise for older adults with chronic pain

Conditions: Chronic Pain; Older Adults; Acceptance and Commitment Therapy; Exercise; Psychosocial Intervention; Art

Summary: the objective is to investigate on the effectiveness of acceptance and commitment therapy and exercise in: (primary outcomes) 1. increasing psychological flexibility 2. reducing pain interference 3. increasing quality of life 4. increasing physical functioning (secondary outcomes) 5. reducing psychological distress - depression \& anxiety

chronic pain is classified as persistent or recurrent pain for more than 3 months associated with physical disability, depression and poor psychosocial functioning among older adults; causing a dependence on medication and decreasing their quality of life. there are various treatment options from chronic pain, but the benefits on pain outcomes are minimal and rather short term. psychological interventions, such as acceptance and commitment therapy (act), have shown positive effect on older adults with chronic pain. using the three core elements of psychological flexibility, older adults are encouraged to establish a different relationship with pain: 1) be present; 2) do what matters; and 3) open up. growing studies are exploring the application of biopsychosocial model in pain management, using multidisciplinary interventions. this rct aims to explore the effectiveness of combining act and exercise with two arms: 1) art and exercise; and 2) treatment as usual.

Eligibility criteria:
inclusion criteria: * age 60 years or above; and * have depressive symptoms of mild level or above (phq \> 5) * have chronic pain (\>3 months) * able to give informed consent to participate exclusion criteria: * known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, parkinson's disease, or dementia * (temporary exclusion criteria) imminent suicidal risk difficulty in communication * have had stroke, fracture, cardiovascular disease, cardiovascular surgery, artery disease, surgery on vertebrae, and knee replacement in the past 6 months * physical activity prohibited by a medical professional
exclusion diet vs corticosteroids in patients with active crohn's disease

Conditions: Crohn Disease

Summary: crohn's disease exclusion diet (cded) is a whole-food diet coupled with partial enteral nutrition. the main objective of this trial is to assess whether cded is superior to corticosteroids, in terms of endoscopic response, in patients active cd. the primary endpoint is endoscopic response at week 16, without corticosteroids or further therapeutic intervention, assessed by a centralized, anonymous and blinded, double lecture panel of panenteric pillcam crohn's capsule. this is a multicentre, open-label, comparative, randomized, 2:1, controlled, single-blind, superiority trial. patients included are aged 16 to 70 years, have mild to moderate, luminal, active cd, and have active endoscopic lesions. eighty patients will be randomized between cded (n=56) and corticosteroids (n=24) in centres in france, israel and the netherlands.


Eligibility criteria:
inclusion criteria: * patients aged 16 to 70 years, * with mild to moderate, luminal, active cd, defined by a cdai of 150 to 350, * involving the small bowel, and/or the colon * not treated with corticosteroids at baseline * patent small bowel as assessed by the patency capsule * active endoscopic lesions, as defined by lewis score ≥ 225 in the small bowel and/or ses-cd≥ 4 in the colon. the eligibility of the patient will be determined by the site investigator and a central reader. * informed consent to participate in this study. in patients from france and israel who are aged less than 18: parents' informed consent to participate in this study (parents' agreement is not required in patients aged 16 to 18 in the netherlands) * affiliation to social security or any health insurance exclusion criteria: * inability to follow the cded during 16 weeks. * prior intolerance to corticosteroids. * ongoing infections, evolving virus diseases. * live vaccines. * psychotic state not controlled by treatment. * arthritis or uveitis as main presenting symptoms. * patients with severe and/or predominant rectal or perianal disease. * heavy smokers (more than 10 cigarettes per day). * infliximab, adalimumab, methotrexate or azathioprine initiated less than 3 months before inclusion in this trial. * vedolizumab, ustekinumab initiated less than 6 months before inclusion in this trial. * change in methotrexate, azathioprine, infliximab, adalimumab, vedolizumab or ustekinumab dosage less than 3 months before inclusion. * pregnant or lactating women. * patients already included in a biomedical research other than an observational study (e.g. registry, cohort, biobank). * severe pubertal delay (tanner 1 or tanner 2) and/or height velocity z-score \< 2.5 and/or bone mineral density z-score (hip or lumbar spine) \<2.5. * persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under sections l.3212-1 et l.3213-1 and persons admitted to a health or social institution for purposes other than research (l.1121-6)

Keywords: crohn disease diet corticosteroids
aromatase (cyp19) polymorphism between ai-responsive and ai-resistant breast cancer in korea

Conditions: Polymorphism; CYP19; Aromatase Inhibitor

Summary: aromatase(cyp19)inhibitor is one of the major antihormonal drug for breast cancer in postmenopausal women. the variation of cyp19 may affect the effect of aromatase inhibitor. however, the incidence of variation of cyp19 in korea has not known. therefore, the investigators want to know the incidence of variation of cyp19 and to assess the effect of these variations of cyp19 to aromatase inhibitor users.


Eligibility criteria:
inclusion criteria: * hormone receptor positivebreast cancer patient * postmenopausal women * first user of aromatase inhibitor exclusion criteria: * premenopausal * the patient who take the other antihormonal therapy * osteoporosis patients
botulinumtoxin a as a treatment for myalgia and myofacial pain in patient with temporomandibulardisorders

Conditions: Temporomandibular Disorder

Summary: both patients and remitters ask for treatment with botulinumtoxin a (btx) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent. the aim of this project is to investigate if injections with btx in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (tmd) and if the effect of btx is dose dependent.

the primary goal with this study is to expand treatment modalities for patient with myogenous tmd, and to develop clinical protocols with adequate doses for myogenous tmd. a secondary goal is to study if there are differences in treatment effect between sub-groups of myogenous tmd for more personalised pain-treatment. hypothesis the investigators hypothesis is that application of btx into the masseter and temporalis muscle will reduce pain and increase quality of life in patients with myogenous tmd, and that the reduction of pain is only to a certain degree due to the dose. high doses of btx does not necessarily entail increased reduction of pain or better quality of life. the investigators also hypotheses that the effect may differ in sub-groups of myogenous tmd.

Eligibility criteria:
inclusion criteria: * has given a written consent * diagnose of myalgia, myofacial pain or myofascial pain with referred pain according * average pain due to nrs ≥ 3 for more than three months * palpationpain in masseter or temporalis. * eventual treatment for orofacial pain \> three months ago. * adequate contraceptives and a negative pregnancy test. patients will still be included even if they have one or more co-diagnoses * discdisplacement with or without reduction * degenerative joint disease * arthralgia exclusion criteria: * treatment with btx during the last 12 months * treatment for orofacial pain within the last 3 months. * systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) * widespread pain e.g., fibromyalgia * neuropathic pain * neurologic disease (myasthenia gravis) * pain of dental origin * use of muscle relaxants, or aminoglycoside antibiotics * pregnancy or nursing * hypersensitivity to btx * neuropsychiatric conditions. * difficulties understanding the swedish language
genetic determinants of hemodynamic response to esmolol

Conditions: Decrease in Heart Rate Below Baseline Value

Summary: beta 1 adrenergic antagonists (beta blockers) have major role in the treatment of chf, ihd and hypertension. however, there is large interindividual variability in the response to beta blockers. the hypothesis underlying this study is that genetic differences between individuals will determine the individual response to esmolol, a betablocker that is administered intravenously. esmolol will be administered intravenously to healthy volunteers, and the effects on heart rate and blood pressure will be monitored. in addition, we will measure plasma renin activity and plasma levels of norepinephrine.


Eligibility criteria:
inclusion criteria: * healthy male and female * able to understand and sign informed consent exclusion criteria: * consumption of any medication * bradycardia \<50 bpm * hypersensitivity to beta blockers

Keywords: heart rate
validation of neurokeeper's algorithm on patients undergoing carotid endarterectomy

Conditions: Stroke

Summary: the primary objective of the study is to validate an eeg base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing carotid endarterectomy. the secondary objectives is measure time from ica clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection thi study is a prospective, open label, single arm, self control, single center study. this study will be conducted in 50 subjects according to the inclusions/exclusions criteria.


Eligibility criteria:
inclusion criteria: * age \> 18 years old. * primary carotid endarterectomy under local anesthesia in symptomatic or asymptomatic patients. exclusion criteria: * general anesthesia * selective carotid artery shunting. * previous major hemispheric stroke. * any known major hemispheric lesion. * significant movement disorder. * local skull or skin affliction which prevents electrodes application. * any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Keywords: stroke
nursing care for breathing discomfort among mechanically ventilated patients

Conditions: Dyspnea

Summary: breathing discomfort (dyspnea) during mechanical ventilation in the icu may complicate care.

patients on ventilators experience a variety of discomforts: symptoms (dyspnea ,fatigue , pain ) ,emotions (depression, anxiety ,panic) and feeling of lack to control .patients may or may not express this discomfort outwardly with agitation ,restlessness ,grimacing or increase in the vital signs (heart rate ,blood pressure ,breathing frequency).the aim of the present study is to assess the prevalence of dyspnea among mechanically ventilated patients, describe interventions that may alleviate breathing discomfort and examine its impact on clinical outcomes.

Eligibility criteria:
inclusion criteria: * intubated or tracheostomized patients who were mechanically ventilated for \>24 hrs. * age : 18-60 yrs * patients with respiratory diseases * patients during spontaneous breathing trial exclusion criteria: * • patients with acidosis, anemia ,drug poisoning,psychogenic disorders or neuro-muscular disorders * (non invasive ventilation)niv