Kornimate/medical-research-clean huggingface dataset:
e-health app and lifestyle changes during pregnancy

Conditions: Pregnancy; Dietary Habits; Physical Activity; Gestational Weight Gain

Summary: the purpose of this online follow-up study is to investigate health app use in pregnant women and through a pilot intervention trial investigate whether the addition of evidence-based information on health-promoting lifestyle delivered via the health app has an effect on lifestyle habits (gestational weight, diet quality and physical activity) during pregnancy.

an online follow-up study with a 2-arm equal allocation parallel randomized controlled pilot intervention trial with pregnant women (n=1000) will be conducted. the intervention consists of non-personalized, evidence-based information on health-promoting lifestyle during pregnancy delivered via a health app. control group uses the health app without health information. aims of an exploratory part of the study are to characterize the health app use and users among pregnant women and to investigate whether the frequency of the health app use during pregnancy has an effect on lifestyle habits. aim of the pilot intervention is to investigate whether the addition of evidence-based information on health-promoting lifestyle delivered via the health app has an effect on lifestyle habits during pregnancy.

Eligibility criteria:
inclusion criteria: * pregnant, less than 28 pregnancy weeks * fluency in finnish exclusion criteria: * not pregnant * no fluency in finnish

Keywords: pregnancy health application diet quality physical activity gestational weight gain
proteus: evaluating the use of artificial intelligence to support stress echocardiography testing for heart disease

Conditions: Coronary Heart Disease

Summary: proteus is a multicentre, two arm, randomised controlled trial of a medical device to assess the impact of the introduction of echogo into the standard care pathway for stress echocardiology.

title: a prospective randomised controlled trial evaluating the use of ai in stress echocardiography trial design: multi-centre, two-arm, randomised controlled trial of a medical device. randomised 1:1 to either: * standard care (comparator), or * standard care plus ai platform (echogo) trial participants: adults undergoing clinically indicated stress echocardiogram (se) to assess inducible ischaemia at participating nhs trusts. having benchmarked the device performance (upton 2019), and having successfully deployed and tested the required infrastructure, we now propose to prospectively test the software in clinical practice. based on the existing data for accuracy we would expect use of the echogo platform in the clinical pathway will have a significant benefit reducing inter-reader variability, increasing accuracy and thereby reducing health costs. to formally evaluate the impact of automated ai quantification and accuracy of the decision to make a referral to coronary angiogram, following stress echocardiography, we propose a prospective, multi-centre, randomised controlled trial that compares provision of an ai derived report to a clinician against clinician-only standard of care. this will provide the highest level of evidence of any potential benefit or disadvantages prior to adoption of the software for widespread clinical implementation.

Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * male or female, ≥18 years of age at study entry * referred to an nhs trust for stress echocardiography for investigation of ischaemic heart disease exclusion criteria: * more than moderate valvular heart disease * left ventricular outflow tract obstruction defined as a gradient \> 30mmhg (fixed or dynamic; supravalvular, valvular or sub-valvular) * significant co-morbidities (e.g. cancer) with an expected life-expectancy of under 12 months in the investigator's opinion * previous coronary artery bypass graft or other cardiac surgery * congenital or inherited myocardial disease
impact of mindfulness based stress reduction on anxiety, depression and qol in women with intrauterine adhesion.

Conditions: Asherman Syndrome

Summary: the purpose of this study is to determine whether mindfulness based stress reduction are effective on improve anxiety, depression and quality of life in women with intrauterine adhesion

this is a parallel arm, randomized controlled trials, according to 1: 1 ratio assigned intrauterine adhesions patients to mindfulness based stress reduction group and wait-list control group.the study compared anxiety and depression levels and quality of life in patients with intrauterine adhesions before and after the completion of mindfulness based stress reduction program.anxiety, depression and quality of life level measured by the zung self-rating anxiety scale, zung self-rating depression scale and the 36-item short-form health survey.

Eligibility criteria:
inclusion criteria: 1. meet intrauterine adhesions diagnostic criteria of esge. 2. patients with clear consciousness, can correct understanding related content of the questionnaire. exclusion criteria: 1. have a history of mental illness. 2. receiving psychological treatment currently. 3. have acute mental disorders. 4. experienced special stress life events within six months.

Keywords: asherman syndrome mindfulness anxiety depression quality of life
a novel catheter lock solution for treatment of tunneled hemodialysis catheter-associated bacteremia

Conditions: End-Stage Renal Disease; Hemodialysis Catheter-associated Infection

Summary: the primary objective is to investigate the ability of systemic intravenous antibiotic plus antibiotic/anti-biofilm (i.e. n-acetylcysteine) lock catheter technique in eradicating uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter. secondary objectives include duration to clearance of bacteremia, future recurrence of bacteremia, need for catheter removal and death.


Eligibility criteria:
inclusion criteria: * adult patients who have an indwelling hemodialysis catheter for 10 or more days and evidence of a catheter associated bloodstream infection as evidenced by 1)quantitative blood cultures obtained through the lumen of the catheter yield concentrations of bacterial colonies that are 5 or more fold higher than peripheral blood cultures, or 2)blood cultures obtained through the lumen of the catheter becomes positive 2 or more hours earlier than peripheral blood cultures. exclusion criteria: * patients will be excluded if 1) they are unable or unwilling to provide informed consent, 2) have evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osetoemylitis, deep seated abscesses etc 3)evidence of an exit site infection around the catheter such as a pus pocket, drainage or erythema. 4) patient is allergic to nac or the proposed antibiotic (if patient is allergic to minocycline, tigecycline will not be used). 5) patient is pregnant or will become pregnant.

Keywords: biofilm catheter lock solution catheter salvage
a rural optifast intervention for partial remission of type 2 diabetes in adults with obesity

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: as rural canada is a resource poor health service environment, we propose to test whether an optifast dietary replacement intervention, without the service intensive behavioural component, can cause partial remission of dmii in patients with obesity and dmii.

the objective of this study is to see if a rural-specific optifast intervention, of dietary replacement only, can cause a partial remission of dmii patients with obesity between the age of 18 and 65 diagnosed with dmii within the last 6 years. the goal is to inform the current diabetes routine care by standardizing a rural protocol on the effectiveness of rural-specific optifast intervention for people with dmii who want to attain partial remission of dmii.

Eligibility criteria:
inclusion criteria: * study participants will be patients of the mfht, aged 18 to 65, bmi between 27 and 45 kg/m 2 , and newly diagnosed with dmii within the past 6 years. exclusion criteria: * the exclusion criteria will be anti-hyperglycemic medications, slow onset of type 1 diabetes (dmi) or maturity onset diabetes of the young (mody), renal dysfunction (serum creatinine\>150 μmol/l), history of myocardial infarction, untreated thyroid disease, consumption of 4 alcohol units/day by men and 3 units/day by women, chronic steroid consumption, unstable psychiatric conditions, and atypical antipsychotic medication.
efficacy and safety of posterior scleral reinforcement on controlling myopia in adults with high myopia

Conditions: High Myopia; Posterior Scleral Reinforcement; Adults; Axial Elongation; Myopia Progression

Summary: this study will evaluate the efficacy and safety of posterior scleral reinforcement on controlling myopia progression, including change in refraction, axial elongation as well as sight-threatening complications, in adults with high myopia. half the adults will receive posterior scleral reinforcement, while the other half will receive no surgerical treatment.


Eligibility criteria:
inclusion criteria: * cycloplegic spherical equivalent less than -6.0 d * myopia progression greater than 1.0 d per year * normal iop, no strabismus or any other ocular pathological changes * no any other ocular or systematic diseases that may affect refractive development exclusion criteria: * currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on) * unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing
extended antibiotic therapy in postoperative of laparoscopic cholecystectomy in acute cholecystitis

Conditions: Acute Cholecystitis

Summary: acute cholecystitis (ac) is a very common complication of cholelithiasis, encountered in 20% of symptomatic patients. nowadays laparoscopic cholecystectomy (lc) is the standard treatment in mild and moderates forms of diseases and antibiotic therapy in the postoperatory of these patients remains under discussion. however in the beginning, ac presents itself as an steril process, the obstruction of the cystic duct initiates a cascade of inflammation, ischaemia and necrosis, as well as bacterial proliferation within the gallbladder lumen. bactibilia was a significant factor associated with total, as well as infectious, operative complications. regarding this, for some authors, monotherapy with amoxicillin clavulanic (amc) would be the best treatment after lc in patients with mild and moderate cholecystitis without intraoperative complications such as bile peritonitis, cholangitis, gallbladder perforation or abscess. in the other hand, others do not prescribe antimicrobial treatment after surgery in these selected patients. there is controversy regarding the postoperative treatment with antibiotics in patients with mild and moderate cholecystitis and all the evidence about this topic. therefore, investigators decided to conduct a prospective randomized study in patients undergoing laparoscopic cholecystectomy for acute mild and moderate cholecystitis cancer. the patients will be randomized to receive amc or placebo after surgery. with this study investigators intend to prove that are no clinical differences in postoperative outcomes between patients treated with amc and placebo. the primary aim of the trial is to assess that there are no benefits in the use of postoperative antibiotics in patients whit mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy was performed.

double blind randomized clinical trial

Eligibility criteria:
inclusion criteria: * 18 to 85 years old * patients with diagnose of mild or moderate acute cholecystitis. * underwent laparoscopic cholecystectomy on italian hospital of buenos aires exclusion criteria: * they refuse to participate from the trial or the process of informed consent. * have known allergies or hypersensitivity to mosapride or lactose (used for placebo). * patients with severe cholecystitis * patients with moderate cholecystitis who presents liver abscess, gallbladder abscess, cholangitis or bile peritonitis. * intraoperative findings like liver cancer, liver metastases, common bile duct stones or gallbladder carcinoma. * patients with conversion to laparotomy * previous treatment with antibiotics for more than five days. * patients with active oncological diseases, aids, diabetes, transplanted.

Keywords: acute cholecystitis. amoxicillin clavulanic
investigation of avacen thermal exchange system for fibromyalgia pain

Conditions: Fibromyalgia

Summary: hypothesis: daily use of the avacen thermal exchange system for 4 weeks will show improved fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and psychological assessment. this non-invasive device is able to rapidly raise the core body temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating element. the change in body temperature may change the sympathetic nervous system's activity and thereby reduce fibromyalgia pain.


Eligibility criteria:
inclusion criteria: * fibromyalgia diagnosis * over the age of 18 * understands english * not pregnant/planning to become pregnant * average pain of 4 or greater over the last week (10 point scale) * fibromyalgia pain lasting longer than 6 months exclusion criteria: * pregnant/planning to become pregnant * major unstable psychiatric illness * major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months

Keywords: fibromyalgia pain non-invasive arthritis rheumatoid disease
pilot study of an intervention involving cognitive training and tdcs in morbidly obese subjects

Conditions: Obesity, Morbid; Obesity (BMI > 35) and Diabetes Mellitus; Obesity (BMI > 35) and High Blood Pressure; Obesity (BMI > 35) and Dyslipemia

Summary: the study aims to: 1) investigate the effects of cognitive training (ct) and combined ct and transcranial direct current stimulation (tdcs) on food intake and 2) to further understand its neuropsychological and neurophysiological basis (i.e. eeg) as well as its impact in endocannabinoids (ec) in a sample of morbidly obese patients seeking for a gastric bypass surgery

the study will explore the impact of a 4-day intervention with either ct (active control condition) or ct+tdcs (active condition) stimulation on food intake in a sample of morbidly obese patients, as measured by dietary assessments the week before, during and the week after the intervention. additionally, to further understand the neuropsychological and neurophysiological basis of its impact, measures of executive function and attention performance and eeg recordings, respectively, will be collected. furthermore, we will explore the effect of the intervention on endocannabinoids previously related to eating behaviour. the active control condition will receive sham stimulation together with ct, through a computerized cognitive training platform (guttmann neuropersonaltrainer), including different tasks with designed to train executive functions and attention. each session will last approximately 30-40 min. the active condition will receive tdcs stimulation (20 min, multichannel with an excitatory target over the r-dlpfc) together with ct (same as for the active control condition). participants will undergo a basal (the week before intervention) and a post treatment assessments (the day after finishing the intervention) that will include medical history, blood testing, anthropometric measures, a cognitive assessment battery and a 4-day dietary assessment.

Eligibility criteria:
inclusion criteria: * subjects of both gender, aged between 18 and 60 years-old * having a bmi \> 40 kg/m2 or having a bmi\>35 and suffering from diabetes mellitus, hbp or ldp. * obesity conventional treatment failure * wish of bariatric surgery * accepting the study and signing the informed consent exclusion criteria: * do not meet inclusion criteria * being left-handed * using a pacemaker or deep cerebral stimulation device * having a psychiatric disease or serious disease * neurologic condition or learning issue or mental backwardness that could affect cognitive function * use of psycho-stimulating medicines and/or drugs, abuse or dependance to a psychoactive substance (or during the last 6 months) * dependance to alcohol or/and drugs (excepted from nicotina) * in treatment with benzodiazepines, antipsychotics, tricyclic antidepressants or topiramate, started in the last month * history of psychiatric disorders treated with lithio carbonate. * cutaneous lesion on the area of using of electrodes * contact allergy to material used in the used devices.
vactosertib in combination with pembrolizumab for pd-l1 positive non-small cell lung cancer (nsclc) subjects

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is phase 2, open label, multi-center study to assess safety and efficacy of vactosertib in combination with pembrolizumab as 1st line treatment for subjects with advanced or metastatic, pd-l1 positive, non-small cell lung cancer (nsclc) who have not previously received systemic therapy for advanced disease and in whom egfr, alk, braf, ros1-directed therapy is not indicated.

approximately 55 nsclc subjects with pd-l1 tumor proportion score (tps) ≥ 1% are expected to be enrolled in this study. subjects' tps will be determined by pd-l1 ihc 22c3 pharmdx assay performed according to local laboratory regulations prior to study enrollment. subjects who received adjuvant or neoadjuvant therapy are permitted onto the study if the therapy was completed at least 12 months prior to the development of metastatic disease. eligible subjects will receive: • vactosertib 300 mg orally (po) bid for 5 days with 2 days off period (5 days on/2days off) and pembrolizumab 200 mg iv on day 1 of every 3-week cycle (q3w).

Eligibility criteria:
inclusion criteria: * have a histologically- or cytologically-documented nsclc advanced or stage iv lung cancer * have confirmation that egfr, alk, braf, ros1-directed therapy is not indicated * have measurable disease based on recist 1.1 * pd-l1 expression is ≥1% as determined by the pd-l1 ihc 22c3 pharmdx assay * have a life expectancy of at least 3 months. * ecog 0 or 1 * subjects must be able to swallow tablets and absorb vactosertib. * have adequate organ function as indicated by the following laboratory values in exclusion criteria: * is currently participating in a study of an investigational agent * has received prior systemic cytotoxic chemotherapy for metastatic disease/ antineoplastic biological therapy /had major surgery / radiation therapy to the lung * has received a live vaccine within 30 days prior to the first dose of study drug. * is taking prohibited medications * has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * has known active central nervous system (cns) metastases and/or carcinomatous meningitis. * had a severe hypersensitivity reaction to treatment with another mab previously. * has severe hypersensitivity to vactosertib and/or any of its excipients
sts & acc foundation's transcutaneous valve therapy (tvt) registry foundation's transcutaneous valve therapy (tvt) registry

Conditions: Transcutaneous Valve Therapies

Summary: the tvt registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies.

the tvt registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. patient-level data are submitted by participating hospitals to the society of thoracic surgeons (sts) and american college of cardiology foundation's (accf) joint tvt registry. the purposes of the tvt registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving tvt; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; and (iii) permitting and fostering appropriate research based upon the data collected by means of the tvt registry. the secondary aim of the tvt registry is to serve as a scalable data infrastructure forpost market studies.

Eligibility criteria:
inclusion criteria: * adult patients (age 18 and older) who undergo an attempted transcutaneous aortic or mitral valve therapy procedure, with an fda approved device. exclusion criteria: -
assessment of seminal levels of cystatin c and endoglin in infertile men with varicocele

Conditions: Varicocele; Infertility, Male

Summary: varicocele is a major contributor in male infertility. the improvement of sperm parameters after varicocelectomy supports this contribution. the pathophysiological mechanisms of varicocele-induced male infertility are still under investigation. cystatin c (cys c) and endoglin are secreted glycoproteins that recently linked to several cellular changes common in varicocele like apoptosis and autophagy.

subinguinal varicocelectomy under general anesthesia and complete aseptic condition was done to infertile men with varicocele

Eligibility criteria:
inclusion criteria: * infertile men * varicocele * poor sperm parameters exclusion criteria: * men with systemic diseases * infertile men due to other causes than varicocele

Keywords: male infertility varicocele cystatin c endoglin