Kornimate/medical-research-clean huggingface dataset:
fam-cam translation and validation into german

Conditions: Delirium; Critical Illness; Family Members

Summary: validation and translation of the family confusion assessment method (fam-cam) into german according to principles of good practice for the translation and cultural adaptation process for patient-reported outcomes of the international society for pharmaoeconomics and outcome research and comparison to cam-icu.


Eligibility criteria:
inclusion criteria: * intensive care stay ≥ 48 hours * expected rass ≥ 3 * communication possible in german (minimum of c1 level of common european framework of reference for languages) exclusion criteria: * preexisting psychosis, dementia or depression

Keywords: delirium family members critical illness abcdef validation translation famcam cam-icu
study on eating habits and association with "omic" profiles in families with a subject affected by a chronic immune-mediated inflammatory pathology. observational multicenter study.

Conditions: Juvenile Idiopathic Arthritis (JIA); Crohn Disease (CD); Ulcerative Colitis (UC)

Summary: the proposed study is part of a pnrr 2022 project (call "non-communicable chronic diseases (ncds) with high impact on healthcare and social assistance systems," currently awaiting funding response) and represents the continuation of an observational clinical study named transmic, approved by the pediatric ethics committee of the tuscany region. transmic was an integral part of a european research project within the joint programming initiative (jpi), under the hdhl-intimic theme: "a healthy diet for a healthy life," aimed at understanding the cause-effect relationships between diet, gut microbiome, and human health. understanding the role of diet in inflammatory bowel diseases (ibd) and exploring its role in autoimmune inflammatory conditions with joint manifestations, such as jia, provides additional insights into the development, progression, and management of these conditions, opening new horizons for the use of dietary treatments in preventing these inflammatory conditions.


Eligibility criteria:
inclusion criteria: for families with at least one child/adult affected by ibd/jia: * father and mother with children aged between 0-18 years, in good health. * at least one adult or one child affected by ibd, or a child affected by jia, regardless of ongoing therapy and without distinction of disease severity or activity. for healthy families: - father and mother with children aged between 0-18 years, in good health and not affected by chronic inflammatory bowel diseases or chronic autoimmune inflammatory diseases in general. exclusion criteria: for subjects affected by ibd: * monogenic disease * children with an ileostomy or who have undergone a colectomy for subjects affected by jia: - no exclusion criteria for healthy subjects: - any chronic inflammatory bowel disease, autoimmune disease, or ongoing infectious diseases.

Keywords: jia dietary habits cd uc ibd
precision diagnosis and prospective cohort study for myasthenia gravis: multicenter analysis in china

Conditions: Myasthenia Gravis

Summary: the present study is a prospective cohort study aiming to improve the clinical capacity in the diagnosis and natural history of chinese patients with myasthenia gravis (mg). 300 mg patients are planned to recruit, document and prospectively follow up. management of screening test and cohort manifestation are studied.


Eligibility criteria:
inclusion criteria: * fluctuating muscle weakness and fatigability, along with one of the below: * more than 10% amplitude decrement in low frequency repetitive nerve stimulation,less than 10% amplitude increment in high frequency repetitive nerve stimulation; * anti-achr or musk antibody positivity; * positive to the neostigmine test; * understanding and assigning the informed consent form, and having a good compliance with the follow up. exclusion criteria: * excluding the possible diagnosis of lambert-eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc; * poor compliance to the follow up.

Keywords: myasthenia gravis precision diagnosis antibody detection
evaluation of safety and effectiveness of the sherpapak in donation after circulatory death heart transplantation

Conditions: Heart Transplant Failure; Determination of Death; Outcomes Research; Extracorporeal Membrane Oxygenation

Summary: this is a prospective, pilot trial to evaluate the safety and effectiveness of the paragonix sherpapak™ cardiac transport system ("sherpapak cts") in transportation of cardiac allografts recovered from donors after circulatory death with thoracoabdominal normothermic regional perfusion (ta-nrp). sherpapak™ cts is an ultraportable hypothermic preservation and transport system that has been approved by united states food \& drug administration (fda) for clinical use in heart transplantation.

the investigators will accept donors between the ages of 18 and 49 without any known history of coronary artery disease, insulin dependent diabetes, or long-term smoking (\>20 pack/years) and normal baseline cardiac function (ef\>50) assessed with transthoracic echocardiogram. donors will be selected and matched to the recipients based on standard criteria (blood group, cross-match, size match, and clinical stability). the current procedure of donation after circulatory death (dcd) and procurement follows a well-established course. after consent is obtained, the organs are allocated through united network for organ sharing (unos). all organs will be recovered with protocolized unmc dcd ta-nrp technique that involves reestablishment of blood flow in-situ after donor's circulatory arrest using portable venoarterial extracorporeal membrane oxygenation (va-ecmo). organs will be transported from a donor site to recipient center with the sherpapak™ cts. all organs will be transplanted at nebraska medicine. recipients ("subjects") will be followed from transplant through one-year post-transplantation.

Eligibility criteria:
inclusion criteria: 1. recipient is ≥ 19 years old 2. recipient, or their designated healthcare proxy, is able and willing to sign informed consent 3. recipient meets standard listing criteria for heart transplantation exclusion criteria: 1. recipient is \< 19 years old 2. recipient, or their designated healthcare proxy, is unable to sign informed consent 3. recipient has any condition that, in the opinion of the investigator, would make study participation unsafe or would interfere with the objectives of the study

Keywords: transplantation, heart normothermic regional perfusion organ transport
a phase i study of azd1480 in patients with advanced solid malignancies and advanced hepatocellular carcinoma in the escalation phase,non-small cell lung cancer(nsclc) and non-smokers with lung metastasis and gastric cancer and solid tumour in the expansion phase.

Conditions: Solid Tumour; Advanced Solid Malignancies; Child-Pugh A to B7 Advanced Hepatocellular Carcinoma; EGFR and/or ROS Mutant NSCLC; Lung Metastasis Carcinoma; Gastric Cancer

Summary: this is phase i, open-label and dose escalation study to evaluate the safety and tolerability of azd1480(jak2 inhibitor) in asian patients with advanced solid tumors (part a and c) and in patients with advanced hcc (part b) in the escalation phase, egfr or ros mutant nsclc and non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate daily and bid dosing.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older * for part a and c: histological or cytological confirmation of a solid malignant tumour refractory to standard therapies or for which no standard therapies exist. patients with lymphoma \& hcc are excluded. * for expansion : histological or cytological confirmation of * expansion 1: egfr and/or ros mutant nsclc or non-smokers with lung metastasis * expansion 2: gastric cancer or solid tumour with biopsy available (consenting paired biopsies)refractory to standard therapies or for which no standard therapies exist. patients with lymphoma \& hcc are excluded. * for part b : advanced or metastatic hcc, unresectable and incurable with ablative therapy or tace, with no standard therapy available. * eastern cooperative oncology group (ecog) performance status 0-1 with no deterioration over the previous 2 weeks * for part b : child-pugh liver function status classified as a to b7 exclusion criteria: * for any other chemotherapy, immunotherapy or anticancer agents, within 5 half lives or 3 weeks must have elapsed from treatment to of the first dose of investigational product, whichever is shorter. * with the exception of alopecia, any unresolved toxicities from prior therapy ≥ grade 2 of ctcae v4.02 at the time of starting study (except lfts for hcc patients, which may be grade 2 at the time of starting the study) * any of the following conditions:interferon treatment for hbv and hcv prior liver transplantation * inadequate bone marrow reserve or organ function as demonstrated by laboratory values * evidence of established interstitial lung disease(ild) on baseline high resolution computerized tomography(hrct)

Keywords: advanced solid malignancies child-pugh a to b7 advanced hepatocellular carcinoma egfr and/or ros mutant nsclc non-smokers with lung metastasis gastric cancer solid tumour azd1480 jak1/jak2 kinase inhibitor
build 3: bosentan use in interstitial lung disease

Conditions: Idiopathic Pulmonary Fibrosis

Summary: build 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase iii superiority study. the primary objective is to demonstrate that bosentan delays disease worsening or death in patients with idiopathic pulmonary fibrosis.


Eligibility criteria:
inclusion criteria: * signed informed consent * male or female aged 18 years or older (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception.) * proven diagnosis of ipf according to american thoracic society / european respiratory society (ats-ers) statement, of \<3 years, with surgical lung biopsy (slb) exclusion criteria: * interstitial lung disease due to conditions other than ipf. * presence of extensive honeycombing (hc) on baseline high-resolution computed tomography (hrct) scan. * severe concomitant illness limiting life expectancy (\<1 year). * severe restrictive lung disease. * obstructive lung disease. * diffusing capacity of the lung for carbon monoxide \<30% predicted. * residual volume \> or = 120% predicted. * documented sustained improvement of patient's ipf condition up to 12 months prior to randomization with or without ipf-specific therapy. * recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization). * acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements. * chronic heart failure with new york heart association (nyha) class iii/iv or known left ventricular ejection fraction \<25%. * alanine aminotransferase (alt/sgpt) and/or aspartate aminotransferase (ast/sgot) \> 1.5 times the upper limit of the normal ranges. * moderate to severe hepatic impairment. * serum creatinine \> or = 2.5 mg/dl or chronic dialysis. * hemoglobin concentration \<75% the lower limit of the normal ranges. * systolic blood pressure \<85 mmhg. * pregnancy or breast-feeding. * current drug or alcohol dependence. * chronic treatment with the following drugs prescribed for ipf (within 4 weeks of randomization):oral corticosteroids (\>20 mg/day of prednisone or equivalent), immunosuppressive or cytotoxic drugs, antifibrotic drugs, chronic use of n-acetylcysteine (prescribed for ipf). * oral anticoagulants other than those indicated for a venous or arterial thrombotic disease. * treatment with glibenclamide (glyburide) and calcineurin inhibitors (cyclosporine a, tacrolimus) up to 1 week prior to randomization. * treatment with an endothelin receptor antagonist up to 3 months prior to randomization. * participation in the build 1 trial. * treatment with another investigational drug up to 3 months prior to randomization or planned treatment. * known hypersensitivity to bosentan or any of the excipients.

Keywords: build 3 idiopathic pulmonary fibrosis tracleer interstitial lung disease bosentan actelion
comparison of high and moderate intensity statins in achieving the target ldl-c level after acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: this study evaluates the effectiveness of high- and moderate-intensity statins in achieving target low-density lipoprotein cholesterol (ldl-c) levels in patients with acute coronary syndrome (acs). the study aims to determine whether moderate-intensity statins can provide comparable benefits to high-intensity statins, particularly for patients at higher risk of adverse effects from higher doses. the findings may inform treatment decisions and reduce financial and clinical burdens on patients.

statins are the cornerstone of therapy for reducing cardiovascular events in patients with atherosclerotic cardiovascular disease. current guidelines recommend high-intensity statins for patients with acs to lower ldl-c levels by 50% or more. however, emerging evidence suggests that the benefits of lowering ldl-c may be independent of the statin dose and type. this randomized controlled trial investigates the effectiveness of moderate-intensity statins compared to high-intensity statins in reducing ldl-c levels among local populations. the study also explores whether moderate-intensity statins can mitigate adverse effects, such as myopathy or liver dysfunction, commonly associated with high-intensity statin therapy, particularly in populations with lower baseline ldl-c levels and high statin responsiveness. participants will be randomly assigned to receive either high-intensity or moderate-intensity statin therapy. the primary outcome measure is the percentage of participants achieving an ldl-c reduction of ≥50% after three months of treatment. secondary outcomes include the frequency of adverse effects, adherence to therapy, and changes in liver function tests (lfts) and creatine phosphokinase (cpk) levels. the study will contribute to understanding the role of moderate-intensity statins in managing ldl-c levels and guide future clinical practices for patient subgroups at risk of adverse effects from high-intensity therapy.

Eligibility criteria:
inclusion criteria: * participants aged between 25 and 85 years. * both males and females. * diagnosed with acute coronary syndrome as defined in the operational definitions. exclusion criteria: * history of adverse reactions to statins (e.g., hypersensitivity, myopathy, acute renal failure). * current acute liver disease. * pregnant or breastfeeding women. * participants already on statin therapy

Keywords: acute coronary syndrome hydroxymethylglutaryl-coa reductase inhibitors low-density lipoprotein cholesterol cardiovascular diseases drug therapy, combination
an iodine balance study to investigate the recommended iodine intake in an elderly population

Conditions: Nutrition, Healthy

Summary: current chinese dietary iodine reference intake (dris) standards lack direct data on recommended iodine intake (rni) in the elderly. the elderly have a high prevalence of thyroid diseases. the risk threshold of iodine intake in the elderly is unknown. identifying the appropriate iodine intake for the elderly to maintain optimal thyroid function to reduce the burden on medical resources is a public health issue requiring high attention. the iodine balance study is an important method for exploring physiological iodine requirements. few iodine balance studies have been conducted in the elderly. this study aimed to conduct an iodine balance study and provide information on the appropriate iodine intake level for elderly people.

the investigators measured subjects' food and water intake throughout the day using weighing methods, and collected all urine and fecal samples. food, drinking water, fecal and urine samples were taken to determine iodine concentrations. each subject was required to participate in two phases of iodine balance studies. each stage lasts 4 to 10 days. there was no intervention in the first half of the experiment, and there was an intervention of iodized salt/non-iodized salt consumption in the second half of the experiment. the appropriate level of iodine intake for the elderly was explored by fitting and analyzing the dose change relationship between iodine intake and iodine excretion.

Eligibility criteria:
the target population of this study is elderly people over 60 years old. adults living in the same household can also participate. inclusion criteria: 1. aged 18 and above; 2. at least 5 years of local residence. exclusion criteria: 1. family genetic diseases； 2. special dietary habits； 3. taking iodine-containing drugs or supplements； 4. metabolic diseases; 5. thyroid diseases.

Keywords: recommended intake of iodine iodine balance study thyroid diseases elderly
observational triveneto study on the use of adjuvant hormonal therapies in the treatment of hormone-responsive breast cancer

Conditions: Post Menopausal; Breast Cancer

Summary: there are different types of hormonal therapy medicines for the treatment of hormone-receptor-positive breast cancer. the purpose of this study is to determine the evolution of two types of hormonal treatment (the drug called "tamoxifen" and a group of medicines called "aromatase inhibitors") during two time periods of 12 months each, in years 2006 and 2008, in the northeast italian regions. the study will include post-menopausal women who have initiated hormonal therapy medicines in 2006. the study will also verify the rate of implementation of the updated national and international recommendations for the use of adjuvant hormonal therapy in the hormone-receptor-positive breast cancer.


Eligibility criteria:
inclusion criteria: * post-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy between january 2006 and december 2006 or between january 2008 and december 2008 * documented evidence of the way adjuvant hormonal treatment was initiated. exclusion criteria: * pre- or peri-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy * patients already enrolled in clinical studies aimed at investigating hormone therapies

Keywords: tamoxifen arimidex adjuvant hormonal therapies breast cancer post-menopausal adjuvant hormonal therapy in patients post menopausal with breast cancer
donor-derived cell free dna as a new biomarker in cardiac acute rejection

Conditions: Heart Transplant Rejection

Summary: freedna-car is a prospective, observational multicenter study, that will include a total of 200 adult heart transplant (ht) patients from 14 centers in spain. our main objective is to test donor-derived cell-free dna (dd-cfdna) against endomyocardial biopsy (emb) for the diagnosis of acute cellular rejection.

all patients will be enrolled immediately after ht, and will undergo undergo routine surveillance emb at 15 days, 1 month, 2, 3, 4, 6 and 12 months after ht. simultaneously with each emb, dd-cfdna will be measured in plasma.

Eligibility criteria:
inclusion criteria: * patients \> 18 years old who undergo heart transplant during the recruiting period exclusion criteria: * patients with moderate or severe primary graft dysfunction * patients on invasive mechanical ventilation 15 days after heart transplant * patients on renal replacement therapy, continuous or periodic, 15 days after heart transplant * heart transplant due to a cardiomyopathy that could potentially recur on the graft (cardiac amyloidosis, chagas disease or sarcoidosis, amongst others) * multiorgan transplant

Keywords: donor-derived cell free dna acute cellular rejection
modified technique in sacrospinous fixation for treatment of apical genital prolapse

Conditions: Genital Prolapse

Summary: pelvic organ prolapse is one of the most common benign gynecological disorders and affects approximately 40% of women over 50 years of age. the causes of utero vaginal prolapse are pregnancy, labor, obesity, increased intra-abdominal pressure, and weak pelvic floor structures


Eligibility criteria:
inclusion criteria: 1- symptomatic stage ii , iii and stage iv apical prolapse (diagnosed by pop q test ) . exclusion criteria: 1. patients with medical disorders that may interfere with surgical interventions ( like severe chest and heart diseases , renal and liver cell failure , bleeding tendency ) . 2. patients with urinary incontinence ( excluded by history , examination \& urodynamics)
comparative evaluation of the evolution of arterial and microcirculatory endothelial function in obese patients with type-2 diabetes versus non-diabetic obese patients after a first bariatric surgery

Conditions: Bariatric Surgery; Obese; Type2 Diabetes

Summary: the weight reduction obtained after a first bariatric surgery would improve the vascular (correction of endothelial dysfunction, improvement of arterial wall compliance and evolution of the atherothrombotic process) and microcirculatory function in obese patients with type-2 diabetes.


Eligibility criteria:
inclusion criteria: * the patient is at least 18 years old and under 70 years old * the patient is available for a follow-up of 12 months * the patient signed the consent form * the patient must be affiliated or beneficiary to an health care plan * the patient is followed in hospital day care in the endocrine and metabolic disorders department at nimes university hospital for a first bariatric surgery exclusion criteria: * the subject participates in another interventional study. * the subject is in an exclusion period determined by a previous study. * the subject is under the protection of justice, guardianship or curatorship. * the subject refuses to sign the consent. * it is not possible to give the subject informed information. * the patient is pregnant or breastfeeding. * subject with known advanced atherothrombotic disease (arterial disease of the lower limbs, significant carotid plaque (generating stenosis\> 50%), history of myocardial infarction, stroke) * the subject is type 1 diabetic. * the subject has already had a bariatric surgery.