Kornimate/medical-research-clean huggingface dataset:
frequency of palpebral involvement in adult with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: atopic dermatitis is a common inflammatory skin disease, resulting from genetical, immunological and environmental factors. head and neck are among the most frequent involved areas, almost 50% in adult patients according to most publications. palpebral involvement is also common and a source of major quality of life impairment for patients. however, the real frequency of this palpebral involvement is unknown, only estimated about 20% in few studies. the treatment of this location remains difficult, regarding to the thickness of palpebral skin and proximity of the eye. to our knowledge, no prospective studies about allergological skin tests (such as patch-tests) in atopic patients with palpebral involvement had been conducted. finally, atopic dermatitis is frequently associated with ophthalmological diseases such as conjunctivitis, keratoconus or cataract, which belong to the minor criteria of hanifin and rakja classification. a better knowledge of the atopic dermatitis palpebral involvement and the associated factors seems to be needed to improve the treatment and the quality of life of patients


Eligibility criteria:
inclusion criteria: * atopic dermatitis according to the revised hanifin and rakja criteria (uk working party) * oral consent * valid social insurance exclusion criteria: * personal history of uncontrolled asthma * no social insurance * protective measures * age under 18 * pregnancy or breast-feeding

Keywords: atopic eczema palpebral dermatitis patch-testing ophthalmology allergology atopic dermatitis
study of oral bisphosphonate for osteopenic women treated with adjuvant aromatase inhibitors

Conditions: Breast Cancer

Summary: a single--blind, randomized, placebo--controlled phase ii study to evaluate the impact of oral bisphosphonate treatment on bone mineral density in osteopenic women receiving aromatase inhibitors as adjuvant treatment.

aromatase inhibitors (ais) are the adjuvant treatment of choice in postmenopausal women with early, hormone receptor-positive breast cancer (bc), because they produce improved survival rates compared with tamoxifen. progressive bone loss and subsequent fractures are associated with adjuvant ais, administered either alone or sequentially after tamoxifen in postmenopausal women with early bc. recent findings of national surgical adjuvant breast and bowel project (nsabp) b-34 also suggest that bisphosphonates might have anticancer benefits for older postmenopausal women. "bonadiuv" trial is a single-blind, randomized, placebo-controlled study designed to evaluate the impact of bisphosphonate treatment on bone mineral density (bmd) in women taking ais. patients undergo a baseline bmd and if they result osteopenic (lumbar spine and/or trochanter -1\< t-score \<2.5), they are randomized in a 1:1 ratio to receive either placebo or oral ibandronate. all patients receive oral supplementation of calcium and vitamin d3, once daily for two years. study duration is 2 year, with planned six-months evaluation. a total of 72 patients per arm of treatment are needed to obtain a 85% statistical power in order to detect a 2% bmd mean difference between the two arms. considering a 15% dropout, around 82 patients per arm are planned to be enrolled.

Eligibility criteria:
inclusion criteria: * diagnosis of hormone-receptor positive early breast cancer * menopausal status * age \< 75 years * written informed consent exclusion criteria: * premenopausal status at time of randomization * comorbidities with increased risk of osteoporosis (primary hyperparathyroidism, hyperthyroidism, rheumatoid arthritis) * bmi \< 18 * chronic use of steroids * use of bisphosphonates at time of randomization * psychiatric disorders

Keywords: aromatase inhibitors breast cancer bone mineral density
breast cancer tumor care observational programme

Conditions: Post Menopausal; Arthralgia

Summary: the purpose of this study is to investigate efficacy and tolerability under anastrozole (arimidex) treatment.


Eligibility criteria:
inclusion criteria: * postmenopausal women * already on upfront arimidex therapy (start 1-4 weeks before) * hr+ exclusion criteria: * premenopausal women * tamoxifen switch patients

Keywords: arimidex post menopausal arthralgia
serological profile of children and young adolescents with at least one covid-19 diagnosed family member

Conditions: Covid19

Summary: use of rapid serological tests to assess the vulnerability to sars-cov-2 infection of subjects aged 4-16 years old and cohabiting with at least one family member who tested positive to sars-cov-2

families with at least one child or young adult aged between 4 and 16 years old and with at least one cohabitant who tested positive to nasopharyngeal swab are contacted by phone. those who decide to sign an informed consent after reading the study information will be included in the study. it consists of a preliminary telephone interview and a following rapid serological test for all children and young adults with the age included in the range of interest and the cohabitant who tested positive to nasopharingeal swab. the obtained results will be collected and analysed, and the outcomes of the study will be measured.

Eligibility criteria:
inclusion criteria: 1. children and young adults aged between 4 and 16 years old with at least a sars-cov-2 positive cohabitant 2. adults who previously tested positive to sars-cov-2 with at least a cohabitant aged between 4 and 16 y.o. 3. subjects from the district of sesto san giovanni, lombardy, italy exclusion criteria: 1. children and young adults aged between 4 and 16 years old without at least a cohabitant who previously tested positive to sars-cov-2 2. adults who previously tested positive to sars-cov-2 without at least a cohabitant aged between 4 and 16 y.o. 3. absence of a signed informed consent 4. subject with symptoms suggestive of covid-19 in the last 14 days or disease in progress

Keywords: sars-cov-2 serological test children young adults positive naso-pharyngeal swab family cluster
sems placement before surgery in unblocking bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice

Conditions: Pancreatic Cancer

Summary: this trial studies the side effects of self expanding metal stent (sems) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice. sems placement unblocks the bile duct and may help in improving bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe obstructive jaundice.

primary objectives: i. to compare the 30-day overall complication rates between patients with severe obstructive jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal stents (sems) and patients undergoing direct surgical resection.

Eligibility criteria:
inclusion criteria: * diagnosis of operable peri-ampullary pancreatic cancer as determined by the department of surgery per their standard of care * serum bilirubin \> 10 mg/dl * adequate birth control exclusion criteria: * patients with evidence of distant metastasis on computed tomography (ct) or magnetic resonance imaging (mri) * patients anticipated to require vascular reconstruction * patients with cholangitis * patients for whom surgery is deemed inappropriate by surgeon * patients with bilirubin less than 10 mg/dl or greater than 20 mg/dl * patients who previously underwent biliary decompression for cholangitis by ercp or percutaneous transhepatic cholangiography (ptc) * patients with low performance score (karnofsky performance status scale \< 50) * patients with known preexisting liver disease with associated elevated bilirubin * patients who are pregnant or actively breast feeding
impt-514 in systemic lupus erythematosus, anca-associated vasculitis, and idiopathic inflammatory myopathy

Conditions: Systemic Lupus Erythematosus (SLE); ANCA Associated Vasculitis (AAV); Idiopathic Inflammatory Myopathy (IIM)

Summary: this is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of impt-514, an autologous, anti-cd19/cd20 car t therapy, administered as an intravenous (iv) infusion, in participants with b cell driven autoimmune diseases, including active, refractory systemic lupus erythematosus (sle), anca associated vasculitis (aav), and idiopathic inflammatory myopathy (iim).

this study will explore the safety of impt-514 and will include up to two dose levels, with up to 12 total expected dosed participants for each disease group of sle, aav, and iim. impt-514 treatment consists of a single infusion of car-transduced autologous t cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. individual participants will remain in the active post-treatment period for approximately 2 year from impt-415 administration.

Eligibility criteria:
general inclusion criteria: 1. willing and able to provide written informed consent. 2. age 18 years of age or older and ≤75 years. 3. weight \> 35 kg at enrollment. 4. on stable background therapy (such as mycophenolate, cyclophosphamide, etc.) for autoimmune disease (sle, aav, iim) with stable dose of immunosuppressants for at least 4 weeks prior to screening. for sle participants: 1. diagnosis of sle according to the 2019 european league against rheumatism (eular)/american college of rheumatology (acr) classification criteria or 2012 systemic lupus collaborating clinics (slicc) criteria, including positive ana \>1:80 or positive anti-dsdna. for aav participants: 1. meets the diagnostic criteria for anca vasculitis in 2022 acr/eular, including microscopic polyangiitis (mpa), granulomatous polyangiitis (gpa), and eosinophilic granulomatous polyangiitis (egpa). for iim (dermatomyositis, anti-synthetase syndrome, and immune-mediated necrotizing myopathy) participants: 1. diagnosis of probable or definite iim with subgroup classification of dermatomyositis, or immune-mediated necrotizing myopathy (imnm) subgroup of polymyositis. exclusion criteria: 1. any clinically significant underlying illness, other than systemic autoimmune disease (sle, aav, iim), which would pose a safety risk or concern, as determined by the investigator. 2. rapidly progressive glomerulonephritis. 3. for sle participants: active central nervous system (cns) lupus. 4. history of, or current significant neurologic disease. 5. history of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (such as kidney, lung, heart transplant) or plans for such transplantation in future. 6. history of prior car t treatment, autologous or allogeneic. 7. drug induced sle, drug induced vasculitis or drug induced myopathy or myositis. 8. any primary immunodeficiency. 9. history of, or current significant cardiovascular dysfunction.

Keywords: cd19/cd20 cart
introducing electronic alerts to reduce inappropriate digoxin prescribing in older adults

Conditions: Drug-Related Side Effects and Adverse Reaction; Digoxin Overdose

Summary: the intervention consists of introducing computerized alerts into the electronic medical record of the csapg (mira software), which are triggered when a physician prescribes digoxin at a dose higher than the recommended amount (more than 0.125 mg/day). the main objective of this study is to evaluate the effectiveness of a visible computerized alert aimed at physicians responsible for hospitalized elderly patients who have been prescribed digoxin at a dose higher than 0.125 mg/day (the recommended dose), in reducing the number of patients receiving inappropriate digoxin doses.

intervention this quasi-experimental pre-post intervention study evaluates the effectiveness of computerized alerts integrated into the csapg electronic health record system (mira software). these alerts are triggered when a physician prescribes digoxin at a dose higher than the recommended 0.125 mg/day for elderly patients. study objective the main goal is to assess whether these alerts reduce the number of elderly hospitalized patients receiving inappropriate digoxin dosages. study design and duration the study will last 18 months in total, with a 12-month data collection period at each site (6 months before and 6 months after the intervention). sample size and population to detect a 25% reduction in inappropriate digoxin prescriptions with 80% power and a 0.05 alpha risk, the study requires 2,977 patients in both the pre- and post-intervention groups. inclusion criteria include hospitalized men and women aged 65 and older. no patient exclusions are anticipated. statistical analysis the primary analysis will compare the proportion of patients receiving digoxin doses above the recommended level before and after the intervention using the chi-square test.

Eligibility criteria:
inclusion criteria: * men and women over 64 years of age. * hospitalized in inpatient wards of the study centers during the study period. exclusion criteria: * pacients under 64 years old * patients without complete data available

Keywords: digoxin deprescription beers computerized alerts geriatrics elderly hospitalized patients
a study to find out how fesoterodine works in children aged 6 to 17 years with bladder overactivity caused by a neurological condition

Conditions: Urinary Bladder, Neurogenic

Summary: the objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. children will be aged 6 to 17 years old. this is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. it will be compared with the medicine oxybutynin, which is already available for treating the condition.


Eligibility criteria:
inclusion criteria: * subjects aged 6 to 17 years old * subjects with stable neurological disease and neurogenic detrusor overactivity * subjects using clean intermittent catheterization may participate exclusion criteria: * concomitant medications which may increase the risk to subjects or confound study results * other medical conditions which may increase the risk to subjects or confound study results * contraindications to the use of fesoterodine or oxybutynin

Keywords: neurogenic detrusor overactivity neurogenic bladder neuropathic bladder neurologic disease fesoterodine
stent therapy versus endoscopic vacuum therapy for anastomotic leaks after esophagectomy

Conditions: Leaks, Anastomotic

Summary: exploratory study of the efficiency of endoscopic stenting versus endoscopic vacuum therapy in patients with intrathoracic esophago-gastric anastomotic leakage after oncological resection of the esophagus.

we analyze the outcome of using self-expanding metal stents (sems) and endoscopic vacuum therapy (evt) in the treatment of postoperative leakage after esophagogastrostomy.

Eligibility criteria:
inclusion criteria: * histologically confirmed oesophageal carcinoma or similarly operated neoplasia (e.g., gist, net, subepithelial tumors) * esophagectomy with an intrathoracic esophago-gastric anastomosis * radiologically or endoscopically diagnosed esophago-gastric anastomotic leakage * clinical symptoms / symptoms due to insufficiency or increase in signs of inflammation, most likely as a result of anastomotic leakage * age ≥18 years * to empower the patient to understand the scope of the study and its consequences or information, to consent to it and to sign the educational documents. * written declaration of consent of the patient to be included. if the patient is unable to sign by hand, a witness must confirm the oral examination by signature. exclusion criteria: * macroscopically incompletely resected tumor (r2), palliative resection * endoscopically verified necrosis or critical ischemia of the anastomotic region of the interponate * size of insufficiency more than 50% of circumference * impossibility of radiological interventional insertion of a drainage * early anastomotic leak (≤ 48 hours postoperatively), late insufficiencies (\> 4 weeks) * therapeutic anticoagulation * severe septic shock that indicates surgical therapy * pregnant and lactating women

Keywords: esophagectomy, esophageal cancer, vacuum therapy, stents
an extension study evaluating 6-week treatment cycles of rozanolixizumab in pediatric study participants with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized myasthenia gravis (gmg) aged ≥2 at the time of the screening visit of mg0006.


Eligibility criteria:
inclusion criteria: study participant must meet one of the following: * study participant completed mg0006 according to the protocol * study participant completed the mg0006 treatment period and has a worsening of generalized myasthenia gravis (gmg) symptoms in the observation period of mg0006 exclusion criteria: * study participant met any mandatory withdrawal or mandatory permanent investigational medicinal product (imp) discontinuation criteria in mg0006 or permanently discontinued imp * study participant has a known hypersensitivity to any components of the imp or other neonatal fc receptor (fcrn) drugs * study participant has any laboratory abnormality that, in the opinion of the investigator, is clinically significant, has not resolved at baseline, and could jeopardize or compromise the study participant's ability to participate in this study

Keywords: generalized myasthenia gravis gmg rozanolixizumab pediatric
assessment of cardiac allograft vasculopathy with optical coherence tomography

Conditions: Cardiac Allograft Vasculopathy

Summary: cardiac allograft vasculopathy (cav) is a progressive disease of the coronary arteries in transplanted hearts which is a significant cause of morbidity and mortality. the broad objective of this research study is to advance our ability to diagnose as early as possible the presence of cav and to non-invasively predict those patients at increased risk of cav with novel techniques. optical coherence tomography (oct) is a novel intracoronary imaging technique using an optical analog of ultrasound with a resolution 10 times greater resolution than intravascular ultrasound (ivus). endothelial progenitor cells (epcs) in peripheral blood have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of atherosclerosis) which has been validated in non-transplant patients. patients scheduled for routine cardiac catheterization with ivus at the mayo clinic rochester, minnesota (mn) that reach inclusion and exclusion criteria for the study will be approached on the day to get informed consent to perform oct, blood sampling and peripheral endothelial function testing. the investigators aim to 1) compare the frequency and plaque type of cav as defined with oct versus ivus-virtual histology (ivus-vh), 2) predict the presence and severity of cav with absolute counts of epcs and 3) with peripheral endothelial function scores.


Eligibility criteria:
inclusion criteria: * patients aged 18 or older * patients with cardiac transplant undergoing routine cav surveillance exclusion criteria: * patients \< 18 years old * patients with acute rejection * patients with active infection * patients with chronic renal insufficiency with a glomerular filtration rate (gfr) \< 30ml/min * patients not able to give informed consent

Keywords: oct ivus cav
dysesthesia study after sternotomy

Conditions: Ischemic Cardiopathy; Other Forms of Cardiopathy

Summary: chronic pain associated to sternotomy occurs in 40 to 50% of patients after cardiac surgery. 33 to 66% of these patients suffer during 3 month and 25 to 33% have postoperative pain for at least 1 year. this pain has often negative effects on daily activity. despite its frequency and importance, the etiology of this chronic pain is not completely understood. the goal of this study is to understand the mechanism of this chronic pain, to prevent and/or to treat better in the future. the sensitivity of the thorax after cardiac surgery seems to follow a dynamic evolution which can be observed within several weeks. therefore we decided to study this evolution. this study is different from previous ones observing the sensitivity of the thorax at a well defined moment immediately after the surgery.


Eligibility criteria:
inclusion criteria: * cardiac surgery with sternotomy exclusion criteria: * patients with chronic pain * redo surgery * patients with neurological pathologies * patients treated with antidepressant medication
text messaging for supporting quit attempts

Conditions: Tobacco Use Cessation; Tobacco Use Disorder

Summary: this study is a preliminary research aimed to compare the feasibility and effectiveness of motivational interview (mi), personalized text messages (tm) and usual care for outpatients, with focus on smoking cessation as the main outcome. smokers patients have received brief interventions and nicotine replacement therapy during the hospitalization. after discharge smokers were allocated into a intervention or control arm. in the first and third months, after randomization, the patients were contact to smoke abstinence assessment.

background: research suggests that smokers who receive treatment inside the hospital and post-discharge follow up for at least a month are more likely to quit smoking than those who didn't receive any intervention. the current challenge is to know the best way to support post-discharge quit attempts in the brazilian context. objective: the aim of this study was to compare the feasibility and effectiveness of motivational interview (mi) plus personalized text messages (tm) and usual care for support smoking cessation among post-discharge patients. methods: all patients admitted to the university hospital of juiz de fora (hu/ufjf), between 06/2015 to 01/2016, were asked about the cigarettes consumption in the last 30 days. smokers patients received brief interventions and nicotine replacement therapy during the hospitalization. after hospitalization discharge smokers were allocated into a intervention or control arm. the intervention group received a singular mi session by phone and mobile phone tm twice a day during eight or fifteen days. the control group received only usual care available inside the hospital. results: at the first and third months, after randomization, the patients were contacted for smoke abstinence assessment.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * smoked cigarettes in the last 30 days (even a puff) * have own mobile phone * have received at least one text message in the last year * have no problem with the mobile phone signal exclusion criteria: * don't have a mobile phone * unstable cognitive or physical condition * physical or breath contact restrictions * intensive care units

Keywords: tobacco use disorder hospitalized patients text message motivational interview substance-related disorders behaviors and mental disorders
proton pump inhibitors use in patients with psoriasis

Conditions: Psoriasis

Summary: proton pump inhibitors act in blocking acid secretion and also have antioxidant and anti-inflammatory properties. for that mechanisms possibly ppis may have an anti-inflammatory action with improvement in skin lesions in patients with psoriasis.

proton pump inhibitors act in blocking acid secretion and also have antioxidant and anti-inflammatory properties. for that mechanisms possibly ppis may have an anti-inflammatory action with improvement in skin lesions in patients with psoriasis. the study will assess the evolution of skin lesions in psoriasis patients using ppis

Eligibility criteria:
inclusion criteria: * diagnostic of psoriasis exclusion criteria: * pregnancy