Kornimate/medical-research-clean huggingface dataset:
association between sarcopenia and urinary incontinence and effect of physical activity among over 50 years old adults

Conditions: Urinary Incontinence; Sarcopenia

Summary: as far as the investigators know, until this moment no research has investigated the prevalence of sarcopenia in both sexes in hungary. additionally, no research discovered the association between sarcopenia and ui and the effect of physical activity level on these geriatric conditions in hungary. furthermore, it is known that sarcopenia and ui are causing negative psychological, physical, and social effects on the geriatrics who are suffering from these conditions, not to mention the increase in health care costs. in an attempt to decrease these negative effects, there is a need for a deeper understanding of these conditions by identifying the relationship between them and understanding the risk factors that might cause them. the finding of this study would help with determining those risk factors that are causing these geriatric conditions (sarcopenia and ui). last, this study will provide accurate numbers and statistics to the hungarian health organizations and educational institutions about the prevalence of sarcopenia and ui which will help shed the light on the importance of these problems among older adults in hungary. this cross-sectional study aim to: 1. explore and study physical activity levels among aging adults of both sexes in hungary. 2. to determine the prevalence of sarcopenia and ui among elderly individuals in hungary. 3. investigate the associations between sarcopenia and urinary incontinence among older adults (≥ 50 years). 4. identify the effect of physical activity level on the occurrence of sarcopenia and urinary incontinence hypothesis: 1. the investigators hypothesize that sarcopenia is a risk factor to have ui. 2. the investigators hypothesize that reduced physical activity level is also associated with sarcopenia and/or ui.


Eligibility criteria:
inclusion criteria: • any person who is 50 years old or older exclusion criteria: • individuals who cannot provide reliable clinical information due to cognitive disorders. individuals who are having any neurodegenerative disorders (e.g; parkinson).

Keywords: urinary incontinence sarcopenia
tolerability , pk/pd and safety of dabigatran etexilate oral liquid formulation in children < 1 year of age

Conditions: Venous Thromboembolism

Summary: the aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable pk/pd relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.

purpose:

Eligibility criteria:
inclusion criteria: * neonates and infants with aged \< 12 months at visit 1 * objective diagnosis of vte * end of planned treatment course with anticoagulant therapy as per standard of care at the investigator site. * written informed consent provided by the patient's parent(s) (or legal guardian) according to local regulations at visit 1. exclusion criteria: * weight less than 3 kg at visit 1 * conditions associated with an increased risk of bleeding * renal dysfunction * hepatic disease * anemia or thrombocytopenia at screening
neoadjuvant bevacizumab + chemotherapy combined with short-course radiotherapy

Conditions: Neoadjuvant Treatment; Rectal Cancer; Bevacizumab; Radiotherapy

Summary: prospectively investigate the effectiveness and safety of neoadjuvant bevacizumab + chemotherapy (mfolfox6) combined with short-course radiotherapy (25gy/5fx) for ras mutant-type locally advanced rectal cancer


Eligibility criteria:
inclusion criteria: 1. a biopsy proven histological diagnosis of rectal adenocarcinoma； 2. an arms-pcr proven kras, nras mutation, excluding braf mutation or microsatellite instablility-high; 3. no intestinal obstruction, distant metastasis was excluded by ct, mri or pet / ct; 4. mri proven t3c-t4, crm positive, n2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer; 5. age between 18-75 years; 6. ecog (eastern us cooperative oncology group) score: 0-1; 7. has sufficient organ function: * hemopoietic function: hemoglobin ≥ 90 g / l, platelet ≥ 80 g / l × 109 / l, * neutrophils ≥ 1.5 × 109/l * liver function: alt and ast \< 2.5 × uln; * renal function: serum creatinine \< 1.5 uln; 8. willing to participate and informed consent signed； exclusion criteria: 1. an arms-pcr proven ras wild type, braf mutation and microsatellite instablility-high; 2. patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer; 3. patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ; 4. female patients who are pregnant or breastfeeding; 5. patients with severe heart, liver, or kidney, or neurological or psychiatric disease; 6. patients with active infection; 7. poor overall health status, ecog ≥ 2; 8. patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator; 9. known hypersensitivity reactions to any investigational drugs;
evaluation of the superiority of vasopressin versus noradrenaline in the management of patients at risk of kidney failure undergoing cardiac surgery with extracorporeal circulation

Conditions: Scheduled Cardiac Surgery With Extracorporeal Circulation; Vasoplegic Syndrome

Summary: this is a randomized, double blind, multicenter study following surgery with extracorporeal circulation to compare blood pressure optimization with vasopressin versus noradrenaline. it is planned to include 840 patients in order to have 420 patients with vasoplegic syndrome. the primary objective of this study is to determine whether the use of vasopressin to maintain blood pressure following cardiac surgery decreases the number of patients with acute renal failure and/or death compared with the usual use of norepinephrine. participation in the study involves daily follow-up at d1, d2, and d7 of the onset of the syndrome and then follow-up at d30 and d90.


Eligibility criteria:
inclusion criteria: * patient who has given free, written and informed consent * patient of legal age. * negative pregnancy test for women of childbearing age * patient requiring cardiac surgery: * scheduled (\> 24h) * with extracorporeal circulation (ecc) * myocardial revascularization (coronary bypass), and/or surgical correction of valvulopathy (aortic, mitral, pulmonary, tricupsidian), and/or of the ascending aorta and/or removal of an intracardiac tumor, and/or closure of a pfo/asd * patient with at least 3 risk factors for acute kidney failure including: * age \> 70 years, combined surgery (more than two procedures), common trunk lesion, preoperative anemia, chronic respiratory failure, obliterative arterial disease of the lower extremities, diabetes, glomerular filtration \ 100 min, albuminuria exclusion criteria: * patient not affiliated to national health insurance or not beneficiary of a social security system, * patient subject to a measure of legal protection (curatorship, guardianship), * pregnant, parturient or breastfeeding women, * patients of legal age who are incapable or unable to express their consent, * patients who have already been included in this study * patients requiring emergency surgery (less than 24 hours) * patient with chronic kidney failure on dialysis, * patient with a cardiac transplant, * patient on left-sided monoventricular assistance, * patient on ecmo/ecls, * patient with acute circulatory failure in the immediate preoperative period (sepsis, hemorrhage), * patients with known hypersensitivity to the active ingredient (argipressin) or to one of the excipients of reverpleg®. secondary exclusion criteria: * patient not developing persistent arterial hypotension (vasoplegic syndrome), within 12 hours after completion of surgery, defined as persistent mean arterial pressure (map) \ 2.2 l min-1 m-2, and not responding to 30 mg cumulative of ephedrine in bolus * patient with hemorrhagic shock perioperatively before receiving vasopressor therapy (treatment under study)
iron isomaltoside/ferric derisomaltose vs iron sucrose for treatment of iron deficiency anemia in non-dialysis-dependent chronic kidney disease

Conditions: Iron Deficiency Anaemia; Iron Deficiency Anemia; Chronic Kidney Disease

Summary: evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (ndd-ckd) and iron deficiency anaemia (ida).

iron deficiency anaemia (ida) is a common problem associated with many chronic diseases such as chronic kidney disease (ckd). ida can have a substantial medical and quality of life (qol) burden on the subjects. therapy of these subjects includes treating the underlying cause of ida and restoring haemoglobin (hb) concentration and iron stores. this study evaluated the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects with both non-dialysis-dependent chronic kidney disease (ndd-ckd) and iron deficiency anaemia (ida). the study subjects received either a single intravenous (iv) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or iron sucrose (200 mg iv injections at baseline and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline; a cumulative dose of 1000 mg was recommended). the study subjects were monitored for up to 8 weeks from baseline.

Eligibility criteria:
inclusion criteria includes: 1. men and women, ≥ 18 years 2. hb ≤ 11 g/dl 3. chronic renal impairment, as defined by either (i) egfr \< 60 ml/min/1.73m2 at screening (as calculated by modification of diet in renal disease (mdrd)), or (ii) estimated glomerular filtration rate (egfr) \< 90 ml/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the framingham model 4. screening s-ferritin ≤ 100 ng/ml, or ≤ 300 ng/ml if transferrin saturation (tsat) ≤ 30 % 5. either no erythropoiesis stimulating agent (esas) or esas as a stable dose 4 weeks before randomisation 6. willingness to participate and signing the informed consent form exclusion criteria includes: 1. anaemia predominantly caused by factors other than ida 2. hemochromatosis or other iron storage disorders 3. previous serious hypersensitivity reactions to any iv iron compounds 4. prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy 5. undergoing dialysis for treatment of ckd 6. planned surgical procedure within the trial period 7. decompensated liver cirrhosis or active hepatitis 8. alcohol or drug abuse within the past 6 month. 9. pregnant or nursing women.

Keywords: iron deficiency anaemia iron deficiency anemia ida chronic kidney disease ckd iron isomaltoside ferric derisomaltose monofer monoferric monover monofar monoferro
high intensity focused ultrasound in uterine myoma

Conditions: Uterine Leiomyoma

Summary: aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma


Eligibility criteria:
inclusion criteria: * premenopausal (fsh \< 40 iu/l) * symptomatic uterine fibroids * willing to contracept during study period exclusion criteria: * pregnant or willing to be pregnant in future * cancer in female reproductive organ is suspected or diagnosed * inflammation in female reproductive organ * poorly controlled systemic disease * hematocrit \< 25% * glomerular filtration rate(gfr) \<= 30ml/min * cannot tolerate contrast-enhanced mr or contrast-enhanced ultrasound(ceus) * cannot lie down * previous treatment for leiomyoma, any of ① myolysis, ② myomectomy within 1 year, ③ hormonal therapy longer than 7 days within 4 weeks * cannot count the number or measure volume of leiomyoma using mri * leiomyomas are inadequate (location, volume, number) for intervention * diameter of leiomyoma is over 5 cm * leiomyoma is not enhanced * lactating women * cannot communicate properly * participating or have participated in other trials within 30 days
post-operative crohn's endoscopic recurrence study

Conditions: Crohn's Disease

Summary: this randomised, controlled study aims to evaluate the impact of endoscopic assessment, and adjustment of therapy, after surgery in patients with crohn's disease. the primary endpoint is the severity of endoscopic recurrence. in addition, tissue will be collected for microbiological and immunological analysis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of crohn's and proven history of disease * patient undergone surgical resection with creation of a primary anastomosis exclusion criteria: * endoscopically inaccessible anastomosis by standard colonoscopy * presence of an end stoma * pregnancy * suspected perforation of the gastrointestinal tract * presence of certain unsuitable comorbidities
phase i/ii multiple-dose lea29y vs ctlag4ig vs placebo in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this randomized, double-blind, placebo controlled, parallel and multiple dose study provided safety, preliminary efficacy, and immunogenicity information about the use of bms-188667 and bms-224818 in subjects with ra


Eligibility criteria:
inclusion criteria: * diagnosis of ra \< 5 years * functional class i, ii, or ii as defined by the american college of rheumatology (acr) criteria. * must have failed at least 1 disease modifying anit-rheumatic drug (dmard) * joint count of 10 or more swollen and 12 or more tender. * erythrocyte sedimentation rate (esr) \> - 28mm/rr or norning stiffness \> - 45 minutes. exclusion criteria: * women and men who are not willing to use an accepted form of contraception. * active vasculitis * treatment with another investigational drug within 30 days * history of asthma, angioedema, or anaphylaxix
a study of pegasys (peginterferon alfa-2a) versus untreated control in children with hbeag positive chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this parallel group, open label study will evaluate the safety and efficacy of pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to \<18 years at baseline) with hbeag positive chronic hepatitis b. children without advanced fibrosis and without cirrhosis will be randomized 2:1 to treatment group a, receiving pegasys 45-180 mcg subcutaneously weekly for 48 weeks, or to the untreated control group b. children with advanced fibrosis will be assigned to treatment group c and receive 48 weeks of treatment with pegasys. children in the untreated control group b who have not experienced seroconversion 48 weeks after randomization may enter the switch arm to receive 48 weeks of pegasys treatment. this offer will be available for 1 year following 48 weeks from randomization. anticipated time on study treatment is 48 weeks. all subjects will be followed up for 5 years after the end of treatment (a,c,switch)/principal observation (b) period.


Eligibility criteria:
inclusion criteria: * male or female patients, 3 years to \<18 years of age at baseline * positive hbsag for more than 6 months * positive hbeag and detectable hbv dna at screening * a liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous therapy for hepatitis b) to confirm the presence of advanced fibrosis or exclude cirrhosis * compensated liver disease (child-pugh class a) * elevated serum alanine transferase (alt) * normal thyroid gland function at screening exclusion criteria: * subjects with cirrhosis * subjects must not have received investigational drugs or licensed treatments with anti-hbv activity within 6 months of baseline. subjects who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded * known hypersensitivity to peginterferon * positive test results at screening for hepatitis a, hepatitis c, hepatitis d or hiv infection * history or evidence of medical condition associated with chronic liver disease other than chronic hepatitis b * history or evidence of bleeding from esophageal varices * decompensated liver disease (e.g. ascites, child-pugh class b or c) * history of immunologically mediated disease * pregnant or lactating females
vision outcomes using quantitative optical coherence tomography evaluation in age related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: the investigators have developed an image analysis method that can predict the likelihood that a patient with age related macular degeneration (amd) will progress within 1 year, based on computerized analysis of optical coherence tomography (oct) images that are routinely acquired in clinical practice on each patient visit to the ophthalmologist. the investigators' goal is to evaluate whether this method will improve the ability to detect amd earlier and improve visual outcomes in amd patients by assigning patient risk categories and having patients come back for follow up based on those categories.


Eligibility criteria:
inclusion criteria: * non-exudative age-related macular degeneration exclusion criteria: * exudative age-related macular degeneration
ultrasound-guided venous access for pacemaker and defibrillator implants

Conditions: Cardiac Arrhythmia; Heart Failure; AV Block

Summary: the study will include patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation. a 1:1 randomization will be performed to either standard access (at the discretion of the surgeon) or ultrasound-guided using a wireless vascular transducer (siemens freestyle). primary outcome is mean time to vascular access. in addition, success rate, complication rate and total procedure time will be measured.

pacemaker- and defibrillator lead implants typically involve vascular access via the left cephalic, axillar or subclavian vein. gaining access is usually straight forward for an experienced surgeon/implanter, but can be difficult in a minority of cases, or for implanters with less experience. complications include arterial puncture, pneumothorax and local bleeding or hematoma. traditionally cephalic vein cut-down is the first choice, but is only available in 70% of cases, and for more complex procedures involving three electrodes, an additional access is always required. ultrasound guidance is very common in other vascular access areas such as femoral artery, radial artery and internal jugular vein, but has not gained widespread acceptance in pacemaker procedures. high quality studies, demonstrating superiority or non-inferiority over other access methods are lacking. the present study will include all comer patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation. a 1:1 randomization will be performed to either standard access (at the discretion of the surgeon) or ultrasound-guided using a wireless vascular transducer (siemens freestyle). implanters with various degrees of ultrasound experience and pacemaker surgery experience will participate in the study. all implanters will receive a 2-hour training lecture and additional hands-on training for the first 3 cases, by an ultrasound-experienced anaesthesiologist. access time and success rate will be recorded, and all acute complications will be recorded. primary outcome is mean time to vascular access. in addition, success rate, complication rate and total procedure time will be measured. outcome data will be analyzed for the entire cohort, but also stratified for implanter and excluding the first 10 cases for each implanter, to compensate for various experience and individual learning curve.

Eligibility criteria:
inclusion criteria: * planned pacemaker or implantable defibrillator surgery with at least one new transvenously placed lead. exclusion criteria: * difficult vascular access known before surgery, where special access technique is planned or required.

Keywords: pacemaker implantable defibrillator venous access ultrasound
icg-nir guided lymph node dissection in gastric cancer

Conditions: Stomach Neoplasm

Summary: as the survival rate of patients with gastric cancer has increased, there has been a growing interest in interventions that improve postoperative quality of life. therefore minimally invasive surgery or endoscopic resection has been performed much more frequently. however, adequate lymph node dissection is important as well. the aim of the study is to identify the feasibility of indocyanine green - near infra-red (icg-nir) guided sentinel lymph node dissection for the treatment of gastric cancer.


Eligibility criteria:
inclusion criteria: * dignosed gastric adenocarcinoma * tumor: size 4cm or smaller * depth of invasion: mucosa, submucosa, proper muscle * candidates of laparoscopic radical gastrectomy * informed consent exclusion criteria: * metachronous malignancy * number of tumors: 2 or more * remnant gastric cancer * indication for endoscopic resection * history of chemotherapy or radiation therapy * pregnancy * allergy to icg * metastatic gastric cancer