Kornimate/medical-research-clean huggingface dataset:
an international patient-led registry in fibrotic interstitial lung diseases using ehealth technology

Conditions: Pulmonary Fibrosis

Summary: the i-file study is a prospective multicenter, multinational observational study where the feasibility of a patient-led registry using home monitoring in patients with pulmonary fibrosis will be evaluated. the aim of the study is to gain more insights in disease behavior in patients with pulmonary fibrosis, so in future patients with progressive disease can be better identified.

nowadays, identifying disease progression will have direct treatment implications in patients with fibrotic interstitial lung diseases (f-ilds). ehealth could be a possible solution for close monitoring and detecting disease progression, at a low burden for patients and healthcare providers. the main aim of the i-file study will be to evaluate feasibility of a patient-led registry using home spirometry to monitor disease progression in patients with f-ild. the secondary aim will be to better validate existing health-related quality of life questionnaires to assess the impact of disease and treatment in these patients. in total 500 patients with newly diagnosed f-ild will be included. patients will perform daily home spirometry in the first three months followed by once weekly measurements with a follow up period of 2 years. in addition, patient-reported outcomes (proms) will be completed online every 6 months. results are encrypted and directly sent to a secured server through the online i-file application.

Eligibility criteria:
inclusion criteria: newly diagnosed patients with f-ild according to the ats/ers criteria by a multidisciplinary ild team : * mdt diagnosis ≤ 6 months before inclusion * treatment for f-ild ≤ than 1 month exclusion criteria: * not able to speak, read or write in the native language of the country where the patient is included * not able to comply to the study protocol, according to the judgement of the investigator and/or patient * no access to internet

Keywords: ehealth home spirometry
respiratory muscle training in malnourished patients undergoing abdominal surgery

Conditions: Undernutrition; Surgery

Summary: malnutrition affects 50% of hospitalized patients around the world and causes changes in respiratory muscles predisposing the development of pulmonary complications probable, because of the ineffectiveness of cough. how the training of respiratory muscles can improve the effectiveness of cough, malnourished patients could benefit from this train however, the training of the muscles in malnourished patients has not been tested for safety or efficiency. so, the aim of this study is to assess the safety and efficiency of respiratory muscle training to improve the potency of cough in malnourished patients.


Eligibility criteria:
inclusion criteria: * hospitalized malnourished patients (bmi ≤ 20 kg/m2, loss of body weight ≥ 10% unintentional, or serum albumin \<3.5 g/dl) * candidate to elective abdominal surgery * ability to perform all evaluations and training exclusion criteria: * previous respiratory disease * necessity of over than 48h of mechanical ventilation * reoperation

Keywords: undernutrition abdominal surgery respiratory muscles muscles strength pulmonary complication perioperative care
study of efficacy and safety of inclisiran in japanese participants with high cardiovascular risk and elevated ldl-c

Conditions: Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia

Summary: this was a placebo-controlled, double-blind, randomized trial in japanese participants with history of coronary artery disease (cad) or participants categorized in 'high risk' by jas 2017 guideline, or japanese participants with heterozygous familial hypercholesterolemia (hefh) and elevated low-density lipoprotein cholesterol (ldl-c) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and pk of subcutaneous inclisiran injection(s).

the expected duration of the participants' involvement in the study was approximately 374 days which included screening (up to 14 days), day 1 study drug administration, two additional injections on day 90 and day 270, and the follow-up period to day 360. the primary analysis was conducted after all participants had finished day 180 visit assessments or discontinued before day 180 visit. after the primary analysis, double-blind treatment period were maintained to day 360, although specific sponsor members (except for blinded monitors) were unblinded for the regulatory submission in japan.

Eligibility criteria:
inclusion criteria: * participants with history of cad or participants categorized in 'high risk' by japan atherosclerosis society (jas) 2017 guidelines or participants with heterozygous familial hypercholesterolemia (hefh) * as per the jas 2017 guideline, participants not meeting the ldl-c management targets. * participants on statins should be receiving a maximally tolerated dose. * participants not receiving statins must have documented evidence of intolerance to at least one statin. * the lipid-lowering therapy should have remained stable for ≥ 30 days before screening with no planned medication/ dose change until day 180 exclusion criteria: * participants diagnosed with homozygous familial hypercholesterolemia (hofh). * treatment (within 90 days of screening) with monoclonal antibodies directed towards pcsk9. * new york heart association (nyha) class iv heart failure or last known left ventricular ejection fraction \<25%. * cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation. * uncontrolled hypertension: systolic blood pressure \>160 mmhg or diastolic blood pressure \>100 mmhg prior to randomization despite antihypertensive therapy. * active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (alt), aspartate aminotransferase (ast), \>3x the upper limit of normal (uln), or total bilirubin \>2x uln at screening. * severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.

Keywords: inclisiran sirna dyslipidemia pcsk9 hypercholesterolemia ldl-c
evaluation of potential predictors of disease progression in participants with atypical hemolytic uremic syndrome (ahus) including genetics, biomarkers, and treatment

Conditions: Atypical Hemolytic Uremic Syndrome

Summary: this was a prospective, open-label study with no participant randomization. treatment for ahus was observational and at the discretion of the treating physician. the purpose of this study was to assess disease manifestations of complement-mediated thrombotic microangiopathy (tma) and evaluate potential clinical predictors of disease manifestations and progression in participants with ahus with or without eculizumab treatment in the clinical setting.


Eligibility criteria:
inclusion criteria: 1. currently receiving eculizumab treatment in the m11-001 ahus registry 2. two normal platelet counts at least 4 weeks apart 3. two normal lactate dehydrogenase levels at least 4 weeks apart 4. willing, committed, and able to return for all clinic visits and complete all study-related procedures 5. participant or participant's parent/legal guardian must have been willing and able to give written informed consent. participant (if minor) must have been willing to give written informed assent (if applicable as determined by the central institutional review boards/independent ethics committees) exclusion criteria: 1. any prior eculizumab treatment discontinuation 2. on chronic dialysis (defined as ≥3 months on dialysis) 3. currently participating in another complement inhibitor trial 4. life expectancy of \<6 months 5. participant or participant's parent/legal guardian was unable to give written informed consent. participant (if minor) was unable to give written informed assent (if applicable as determined by the central institutional review boards/independent ethics committees)
magnesium replacement therapy to prevent acute renal failure in critically ill patients

Conditions: Hypomagnesemia

Summary: acute renal failure (arf) is a serious and common complication in hospitalized patients, occurring in more than 25% of intensive care unit (icu) patients. hypomagnesemia is a common disorder, occurring in approximately 12% of hospitalized patients, with an incidence of 60% in icu patients. the majority of those patients have are asymptomatic hypomagnesemia, and patients with mild hypomagnesemia do not need treatment, only the correction of the underlying cause. hypomagnesemia potentiates postischemic renal failure in rats, and is associated, in humans, with acute renal failure. to date, there is no study that demonstrated a benefit of maintain normal levels of magnesium in the incidence of arf in critically ill patients. thus, we suggest that a treatment aimed to maintain normal magnesium levels during icu stay can decrease the incidence of arf. we will perform a randomized clinical trial that will include all patients admitted to an icu that, develop hypomagnesemia. it will be excluded from the study: patients younger than 18 years, participants from other studies, pregnant women, patients with creatinine greater than or equal to 3.5 mg / dl or on dialysis, patients who used intravenous contrast for radiological studies, patients weighing less than 40kg, suffering from advanced malignant disease, with severe hypomagnesemia (serum magnesium less than or equal to 1.1 mg / dl), with a diagnosis of torsades de pointes or symptomatic hypomagnesemia prior to randomization. patients included in the study will be randomized to one of the following groups: placebo (saline solution 0.9%) or 50% magnesium sulfate. patients will receive an administration of 48 meq magnesium diluted in 250 ml saline 0.9% for 24 hours in an infusion rate of 10.4 ml / hr. therapy will be continued for 3 days, and repeated during icu stay to maintain magnesium levels in the normal range. placebo group will receive exactly the same infusion only with saline administration. the therapy will be discontinued if the patient has hypermagnesemia or signs of magnesium intoxication. the main outcome measurement will be the occurrence of arf during icu stay.


Eligibility criteria:
inclusion criteria: * all patients, clinical or surgical, who signed (or their relatives) the informed consent form, which presented hypomagnesemia (with serum magnesium between 1.2 and 1.8 mg / dl), with no symptoms of hypomagnesemia. exclusion criteria: * patients younger than 18 years, participants from other studies, pregnant women, patients with admission plasma creatinine greater than or equal to 3.5 mg / dl or on dialysis, patients who used intravenous contrast for radiological studies, patients weighing less than 40kg, patients suffering from advanced cancer, patients with severe hypomagnesemia (serum magnesium less than or equal to 1.1 mg / dl), patients with a diagnosis of torsades de pointes or patients with symptomatic hypomagnesemia prior to randomization.
pulmonary disposition of tr-700 following once-daily oral 200 mg

Conditions: Bacterial Infection

Summary: the primary purpose of this study is to determine the steady-state plasma pharmacokinetics (pk) and properties of tr-700 into the pulmonary epithelial lining fluid (elf) and alveolar macrophages (am) of healthy volunteers.

no applicable.

Eligibility criteria:
inclusion criteria: * healthy males and females, between 18 and 55 years of age, inclusive * females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control * males must be surgically sterile, abstinent, or practicing an effective method of birth control * bmi between 20 and 34.9 kg/m2, inclusive exclusion criteria: * allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes * physician-diagnosed migraine headaches within 3 years * previous enrollment in a tr-701 or tr-701 fa trial

Keywords: antibiotic healthy subjects pharmacokinetics
a phase i clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous injections of shr-2173 in patients with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: to investigate the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of multiple subcutaneous injections of shr-2173 in patients with systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: 1. age 18-65 years, regardless of gender; 2. weight ≥45.0 kg at screening; 3. confirmed sle diagnosis for ≥12 weeks at screening. exclusion criteria: 1. pregnant or breastfeeding women, or those with a positive human chorionic gonadotropin (hcg) test. 2. history of alcohol abuse or illegal drug use within one year prior to screening. 3. blood donation ≥450 ml within 8 weeks prior to screening or plans to donate blood during the study. 4. current active infection or a history of active tuberculosis 5. other inflammatory or autoimmune diseases beyond sle and ln that may interfere with the interpretation of trial results or clinical assessment.
a one health study of monkeypox human infection

Conditions: Monkeypox Virus Infection

Summary: this multidisciplinary project aim to understand the epidemiology of the monkeypox in central african republic through the identification of the animal reservoir, the clinical and epidemiological description of the human outbreak, through an ethnological approach around risk factors of the disease and through an ecological approach of the ecological context of emergence, and the improvement of biological diagnosis.

this project is composed by monkyepox disease outbreak investigation in the car following national surveillance framework.

Eligibility criteria:
inclusion criteria: * human population in villages affected by monkeypox epidemics: patients who developed monkeypox and their contacts * health care personnel (paramedics, nurses, doctors) who work or have worked in affected villages * traditional healers, diviners * members of villages affected by past monkeypox epidemics exclusion criteria: * area not accessible to investigation * refusal to participate * inability to obtain consent

Keywords: epidemiology outbreak investigation anthropology, animal reservoir zoonotic disease field diagnosis
platelet function operating room monitoring

Conditions: Platelet Dysfunction Due to Drugs; Bleeding

Summary: prospective cohort study on adult cardiac surgery patients. platelet function evaluated before and after cardiopulmonary bypass. bleeding and transfusion recorded. primary endpoint is finding the association between postoperative platelet function and bleeding.

preoperative platelet function is a known determinant of postoperative bleeding in cardiac surgery patients (1,2). conversely, there is a lack of information with respect to postoperative platelet function and postoperative bleeding, and specific cut-off values have not been identified yet. this study will verify the hypothesis that postoperative platelet function is associated with bleeding, and will test the ability of platelet function tests (pfts) in predicting severe postoperative bleeding. additional analyses linking platelet function to other preoperative and intraoperative conditions are planned. patients: enrollment between february 2017 and january 2018. 800 consecutive adult cardiac surgery patients are considered based on our usual surgical activity. exclusion criteria: unwillingness to participate, known congenital coagulopathy. moderate/severe bleeding occurs in about 12% of our patient population. considering a 15% dropout rate, there are about 80 predicted events. power analysis: to build a predictive model, at least 60 events of moderate/severe bleeding are required. the study will be stopped at reaching (whatever comes first) 800 enrolled pts; 60 events; or 31st january 2018. methods: all the patients will receive a preoperative (in the operating room) pft (adptest and traptest) using the aggregometry multiplate (roche). the same test will be repeated after protamine administration at the end of cpb. definitions of bleeding: 12-hours chest drain blood loss; moderate/severe bleeding adjudicated based on the universal definition of perioperative bleeding (3). statistics: roc analysis with identification of adequate cut-off values and definition of the ppv and npv

Eligibility criteria:
inclusion criteria: * cardiac surgery with cpb exclusion criteria: * known congenital coagulopathy
microgreen consumption for healthy aging

Conditions: Aging; Menopause; Healthy

Summary: microgreens are an emerging horticultural food crop with potential to improve human health. previous research suggests they have broad consumer acceptance and that the micronutrient and bioactive compound levels are higher than that of their mature counterparts. to date, no studies have explored the feasibility of microgreen consumption, gastrointestinal tolerance of microgreen consumption, or their potential health impacts in humans. therefore, the overall goal of this study is to explore the feasibility and acceptability of daily microgreen consumption, gastrointestinal tolerability, and potential health impacts of red cabbage and red beet microgreens in healthy middle-aged/older men and postmenopausal women - a population inherently at risk for chronic disease, e.g. cardiovascular disease.


Eligibility criteria:
inclusion criteria: * male or postmenopausal * aged 45-70 exclusion criteria: * cardiovascular disease, hypertension, diabetes, neuropathy, thrombosis, cancer, gastrointestinal, kidney, liver, lung, or pancreatic disease * taking medication for high cholesterol, triglycerides, or blood sugar, or are taking testosterone medications * blood pressure ≥ 130/80 mm hg, triglyceride levels \> 200 mg/dl, low-density lipoprotein cholesterol levels ≥ 160 mg/dl, total cholesterol levels ≥ 240 mg/dl, and/or hemoglobin a1c ≥ 6.5% * weight change ≥ 3 kg (6.6 lb.) in the past 3 months prior to starting the study, are actively trying to lose weight, or are unwilling to remain weight stable throughout the study * have a bmi less than 18.5 or greater than 30 kg/m2 * are not willing to maintain normal eating/drinking and exercise habits over the duration of the study * currently smoke cigarettes or have a history of smoking cigarettes in the past 12 months * taking antibiotics or have taken them within one month of starting the study * binge and/or heavy drinker (\>4 drinks on any given occasion and/or \>14 drinks/week for men) * have allergies or contraindication to study foods, procedures, or procedure supplies
role of the gut microbiota in pediatric epilepsy

Conditions: Drug Resistant Epilepsy

Summary: nearly a third of children with epilepsy are refractory to pharmacotherapy. the ketogenic diet (kd) is a highly effective alternative therapy reducing seizure frequency by 50% in more than half of treated children. the exact mechanisms of kd remain poorly understood, and recent studies have implicated the gut microbiota (gm). this pilot study aims to determine the feasibility of a 12-week dietary intervention with prebiotic fiber in children with epilepsy. the investigators hypothesize that consumption of inulin will alter gut microbiota and may have effects on seizure frequency.


Eligibility criteria:
* inclusion criteria: * children with epilepsy: 1. age 2-18. 2. attended the epilepsy clinic for a minimum of 6 months. 3. on a stable number and type of medications for 4 weeks. 4. have not previously been on the ketogenic diet. * healthy controls: 1. aged 2-18. 2. immunocompetent. 3. no medical comorbidities (e.g. autoimmune, metabolic, cardiovascular, renal, or gastrointestinal conditions). * exclusion criteria: 1. health conditions such as disorders of fatty acid transport and oxidation, porphyria, and pancreatitis, glucose transporter 1 deficiency, pyruvate dehydrogenase deficiency, diabetes, and other autoimmune diseases. 2. presence of hiv infection, chronic wound infection, or osteomyelitis 3. presence of or treatment for periodontal infection 4. inflammatory bowel disease, chronic diarrhea, current clostridium difficile infection 5. treatment with immunosuppressive agents in the past 6 months 6. significant changes in dietary intake (i.e. excluded sugar, lactose or gluten from their diet, started consuming a vegetarian or vegan diet) over the past 6 months. 7. gastrointestinal illness in the past month or food intolerances leading to gastrointestinal symptoms. 8. use of antibiotics in the 3 months preceding the study. 9. use of probiotic or prebiotic supplements in the month preceding the study. 10. consumption of probiotic yoghurt in the past 2 weeks. 11. use of laxatives, proton pump inhibitors, or gastric motility medications in the month preceding the study. 12. history of allergic reaction or intolerance of maltodextrin or inulin.

Keywords: ketogenic diet gut microbiome inulin
belova data collection: safety and efficacy of frontline bevacizumab treatment in participants with ovarian cancer 70 years and older

Conditions: Ovarian Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy in the frontline treatment of ovarian cancer in participants 70 years of age and older in routine clinical practice in belgium. bevacizumab will be used in combination with carboplatin/paclitaxel followed by bevacizumab as maintenance in accordance with the summary of product characteristics (smpc).


Eligibility criteria:
inclusion criteria: * aged 70 years and older * no treatment with any other investigational agent within 28 days or 2 half-lives (whichever is longer) prior to enrollment exclusion criteria: * contraindications, warnings, and precautions for bevacizumab