Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity study of an inactivated influenza vaccine (whole virion, vero cell derived)

Conditions: Influenza

Summary: the objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, vero cell derived). subjects will be randomly assigned to receive a single injection of whole virion, vero cell derived or egg derived influenza vaccine on day 0. subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.


Eligibility criteria:
inclusion criteria: male and female subjects who * are 18 to 45 years of age, inclusive, on the day of screening; * have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry; * are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study); * agree to keep a daily record of symptoms; * if female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study. exclusion criteria: subjects who * have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season; * have received any vaccination within 2 weeks prior to vaccination in this study; * suffer from any kind of immunodeficiency; * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immune response; * have a history of inflammatory or degenerative neurological disease (e.g. guillain barré, multiple sclerosis); * have received a blood transfusion or immunoglobulins within 30 days of study entry; * have donated blood or plasma within 30 days of study entry; * have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications); * have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating; * have a known or suspected problem with alcohol or drug abuse; * are unable to lead an independent life as a result of either physical or mental handicap; * were administered an investigational drug within six weeks prior to study entry; * are concurrently participating in a clinical study that includes the administration of an investigational product; * if female, are pregnant or lactating; * are a member of the team conducting this study or are in a dependent relationship with the study investigator. dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
echocardiography in critically-ill patients with covid-19 pneumonia

Conditions: COVID; Sars-CoV2

Summary: critical care echocardiography (cce) has been widely used since the 10 last years. covid outbreak leads that many patients with acute respiratory failure were admitted in the icu. many of these patients were ventilated and developed ards. some of them developed deep vein thrombosis and pulmonary embolism. nothing is already described about the cardiac function and the hemodynamics in these patients (how many rv failure, lv systolic dysfunction,...). the echo group of the cardiodynamix section of european society of intensive care medicien (esicm) aims to promote cce and evaluate its interest. the objective is to retrospectively enter in an international database all the echo studies done as usual care in these patients to evaluate (i) incidence of rv failure, (ii) incidence of lv systolic function, (iii) incidence of other patterns. another objective will be to look for any association between some patterns and respiratory strategy, blood gas analysis, systemic hemodynamics. the echo studies were done and will be reported following one of the recent systematic review published by the same group (huang s et al. aoic 2020).

multicenter, international observational retrospective study. patients admitted in the icu between march 1th and april 26th for a pneumonia related to sars cov 2 and who had at least one echocardiography during their stay will be included. analysis will be retrospective in order to report the hemodynamic profile with left ventricular and right ventricular function. will be also reported the respiratory settings, the central venous presure if available as well as usual parameters of macrocirculation. all data will be reported in redcap by the university of sydney (https://redcap.sydney.edu.au/).

Eligibility criteria:
inclusion criteria: patients admitted in the icu for pneumonia related to sars cov2 and who had at least 1 critical care echocardiography during the first 28 days. - exclusion criteria: patients who did not have any critical care echocardiography during the first 28 days of the icu stay.

Keywords: critical care echocardiography covid pneumonia icu
the role of surgery for esophageal cancer with metastatic disease (m1)

Conditions: Esophageal Cancer; Metastatic Disease

Summary: treatment of stage iv esophageal cancer is traditionally palliative, but treatment response is usually poor. the role of surgery in the treatment of advanced esophageal cancer remains controversial. we sought to determine whether surgical treatment followed by neoadjuvant chemoradiation therapy might provide survival benefits for these patients. a retrospective review of esophageal cancer patients with m1 disease treated at national taiwan university hospital was performed from april 2002 to june 2021. patient demographics and cancer staging, treatment, and disease recurrence, and time of follow up were included for analysis. univariate and multivariate analysis was performed for overall survival and progression-free survival analysis. propensity score matching based on patient age and tumor staging characteristics was also performed for analysis.


Eligibility criteria:
inclusion criteria: * stage iv esophageal cancer patients * patients were treated with chemoradiation therapy (ccrt) exclusion criteria: * not stage iv esophageal cancer patients * patients were not treated with chemoradiation therapy (ccrt)
matrix metalloproteinases after surgery and/or radiofrequency ablation in patients with liver metastases from colorectal cancer

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research trial is studying matrix metalloproteinases after surgery or radiofrequency ablation in patients with liver metastases from colorectal cancer.

objectives: primary * describe the kinetics of postoperative changes of serum matrix metalloproteinases (mmp) (mmp-1, mmp-2, mmp-7, mmp-9) and their inhibitors (timp) (timp-1, timp-2) as a function of surgical technique. secondary * determine the predictive value of postoperative risk of recurrence. * correlate the risk of recurrence with surgical technique. * determine whether elevated serum levels of mmp are a better marker than the carcinoembryonic antigen of hepatic or extrahepatic recurrence. * determine whether the postoperative serum of hgf/sf is correlated to changes in plasma levels of mmps. outline: blood samples are collected periodically before and after treatment to analyze for metalloproteinases and their inhibitors. after completion of study treatment, patients are followed at day 45 and then every 3 months for 2 years.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * patients with histologically confirmed adenocarcinoma of the colon or rectum and liver metastases * must have undergone prior complete resection of the tumor more than 3 months ago * liver metastases must be resectable or accessible for radiofrequency ablation * patients undergoing cryosurgery of the digestive tract for a reason other than cancer or infection (control) patient characteristics: * no other neoplastic disease that is measurable or being treated other than colorectal cancer * no heart failure or severe respiratory disease * no uncontrolled infection or other severe disease prior concurrent therapy: * see disease characteristics * no participation in another study involving new drugs

Keywords: liver metastases adenocarcinoma of the colon stage iv colon cancer adenocarcinoma of the rectum stage iv rectal cancer recurrent colon cancer recurrent rectal cancer
pediatric chronic kidney disease safety and efficacy

Conditions: Chronic Kidney Disease; Hyperparathyroidism; Hyperparathyroidism, Secondary; Kidney Disease; Secondary Hyperparathyroidism

Summary: the purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.

secondary hyperparathyroidism (shpt) is a condition that can develop early in patients with chronic kidney disease (ckd), usually gets worse over time, and is known to cause problems for patients on dialysis. children on dialysis can have a wide range of bone and growth issues, and common treatments have a chance of making these things worse by increasing serum calcium and serum phosphorus. cinacalcet has been shown to be effective in controlling parathyroid hormone (pth), calcium and phosphorus in adults. the purpose of this study is to show that including cinacalcet in the treatment of shpt will lower the levels of intact parathyroid hormone (ipth) in a larger number of pediatric patients with ckd who are receiving dialysis, compared to a treatment regimen that does not include cinacalcet.

Eligibility criteria:
inclusion criteria: * age 6 to less than 18 years at screening * diagnosed with ckd and shpt receiving hemodialysis or peritoneal dialysis for ≥ 2 months before randomization * dry weight ≥ 12.5 kg at screening * ipth obtained from the central laboratory must be \> 300 pg/ml (31.8 pmol/l) * serum calcium (corrected) obtained from the central laboratory must be ≥ 8.8 mg/dl (2.2 mmol/l) * serum phosphorus obtained from the central laboratory ≥ 4.0 mg/dl (1.3 mmol/l) for children 6 to less than 12 years old, or ≥ 3.5 mg/dl (1.1 mmol/l) for children 12 to less than 18 years old * subjects already receiving vitamin d sterols (either calcitriol or a synthetic analog), a stable dose within the last 2 months prior to randomization * subjects taking growth hormone, a stable dose defined as no change \> than 20% in the last 2 months prior to randomization * subjects on anti-convulsant medication must be on a stable dose for 3 months, and have a therapeutic blood level of the anti-convulsant at the time of randomization * subjects must be on a dialysate calcium concentration of ≥ 2.5 meq/l (1.25 mmol/l) for at least 2 months prior to randomization exclusion criteria: * underwent parathyroidectomy in the last 6 months * anticipated parathyroidectomy within 6 months after randomization * received therapy with cinacalcet (sensipar/mimpara) within the last month * a new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months * scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely

Keywords: dialysis sensipar mimpara hemodialysis peritoneal dialysis renal parathyroid hormone pediatric
diagnostic and prognostic value of combination biomarkers in the critically ill patient with sepsis.

Conditions: Diagnostic and Predictive Value

Summary: sepsis is a common cause for morbidity and mortality in critically ill patients. with the development of medical skills, the mortality is still remain very high. inappropriateness of initial antibiotic treatment is an important risk factor for mortality and effective antimicrobial administration within the first hour of documented hypotension was associated with increased survival to hospital discharge in adult patients with septic shock. however, the early treatment based on early diagnosis.but it is very difficult to diagnosis because of lack of specific clinic symptom and sign.when severe sepsis occur, biomarker could be helpful to diagnosis. unfortunately, the diagnostic value of single biomarker is limited. therefore, combine several biomarkers could enhance the diagnostic value.


Eligibility criteria:
inclusion criteria: * critically ill patients admitted into icu exclusion criteria: * age younger than 18 years * refuse to participate in this study

Keywords: crp, pct, il-6, diagnosis, prediction
study of iti-007 in healthy geriatric volunteers and in geriatric patients with dementia

Conditions: Alzheimer's Disease

Summary: a phase 1b/2, randomized, double-blind, placebo-controlled, multiple oral dose escalation study to assess safety, tolerability and pharmacokinetics of iti-007 in healthy geriatric volunteers and in geriatric patients with dementia


Eligibility criteria:
inclusion criteria: part 1 * healthy geriatric volunteers * mmse score of \>= 26 at screening * bmi between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening part 2 * geriatric patients with a clinical diagnosis of dementia * mmse score of \< 26 at screening * bmi between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening exclusion criteria: * any clinically significant illness within 6 months before screening * any history of cancer within last 5 years * history of hepatitis b or c infection and elevated alt, ast or bilirubin above the upper limit of normal level * any subject considered to be an imminent danger to themselves or others

Keywords: dementia, healthy geriatric volunteers patients
" evaluation of safety and efficacy of empagliflozin and sacubitril/valsartan for chf with reduced ejection fraction in achd "

Conditions: Congenital Heart Disease; Heart Failure; Heart Failure With Reduced Ejection Fraction

Summary: the treatment of adult patients with congenital heart disease (achd) and heart failure (hf) represents a great challenge since, to date, there is no standardized guideline for this specific population. although new treatments for hf have been proposed, such as sodium-glucose cotransporter-2 (sglt2) inhibitors and neprilisin and angiotensin receptor inhibitors, the benefit of these drugs in patients with hf associated with congenital heart disease in adults has not yet been demonstrated. for this reason, this study pretends to evaluate the efficacy of empagliflozin and sacubitril/valsartan in this population.

a 12-week randomized, open label, active-controlled trial to explore the effects of once-daily empagliflozin 10 mg and/or sacutril/valsartan 49 mg/51 mg in the reduction of systemic ventricular volumes (end-diastolic and end-systolic) in adult patients with hf associated with congenital heart disease.

Eligibility criteria:
inclusion criteria: * nyha functional class ii-iv * diagnosis of chd: repaired, palliated or without previous treatment * systemic ventricular ejection fraction \<40% * without unplanned hospital admissions within 3 months prior to randomization * the participant is willing and able to give informed consent for participation in the study exclusion criteria: * pregnant and postpartum women * breastfeeding women during the study * history of drug allergy to any sglt-2 inhibitor and/or sacubitril/valsartan * previous administration of a drug regimen including an sglt-2 inhibitor and/or sacubitril/valsartan * intellectual or physical disability that impedes the subject to perform the 6 minute walk-test * patients with any contraindication to sglt-2 inhibitor and/or sacubitril/valsartan * medical history of myocardial infarction, cardiac surgery or fulminant myocarditis within the last three months * medical history of type 1 diabetes mellitus * medical history of hypertensive crisis in the previous 6-months * medical history of cardiogenic shock or heart failure decompensation in the previous 6-months * medical history of heart transplantation

Keywords: adult congenital heart disease heart failure with reduced ejection fraction empagliflozin sacubitril-valsartan
effect of radiotherapy on attr cardiac amyloidosis : a proof of concept study

Conditions: Amyloid Cardiomyopathy

Summary: cardiac amyloidosis is responsible for significant morbidity associated with heart failure, and carries a poor prognosis. currently there are very limited treatment options for this condition. radiotherapy has been used successfully to treat amyloidosis elsewhere in the body, however has not been tried in cardiac amyloidosis. therefore this study aims to assess the effect of radiotherapy on cardiac amyloidosis, to evaluate whether it can successfully reduce the burden of amyloid deposits in the myocardium as assessed by 18f-amyloid pet.

the intervention will involve administration of external beam radiotherapy (5 fractions of 2gy) focused to the heart. measurements of effect will be assessed at 12 weeks by: amyloid pet cardiac mri with administration of gadolinium and ultrasound a blood venous sample (cardiac biomarkers) quality of life assessments

Eligibility criteria:
inclusion criteria: * age \>65 y.o. * dyspnoea on exertion (nyha ii or more). * stable elevated cardiac enzymes (ultra sensitive troponin t \> 14 ng/l on consecutive sampling or bnp \> 100pg/ml) * a positive 99mtc-dpd cardiac scintigraphy (grade 2 and 3) suggesting an attr or wt amyloidosis. * additional imaging also compatible with cardiac amyloidosis (cardiac ultrasound showing basal to apical longitudinal strain gradient and magnetic resonance imaging with elevated t1 value or extracellular volume). * compliance with the informed consent as attested by its signature. * positive baseline 18f-florbetapir imaging, as assessed visually and quantitatively by a tissue to background ratio \> 1.45 exclusion criteria: * positive serum protein immunoelectrophoresis with monoclonal gammapathy. * previous external beam radiotherapy including the chest. * claustrophobia * presence of internal non-mr compatible devices * creatinine glomerular filtration rate \< 30 ml/min * oncologic disease (excluding skin cancer) active or in remission from less than 5 years

Keywords: cardiac amyloidosis radiotherapy
post-marketing safety surveillance program in human immunodeficiency virus (hiv)-infected children exposed to atazanavir in europe

Conditions: HIV Infection

Summary: the purpose of this study is to monitor adverse events in hiv-infected children \<18 years old who are exposed to atazanavir in a real-world setting in europe.


Eligibility criteria:
inclusion criteria: * hiv-infected children participating in individual prospective paediatric hiv cohorts * receive atazanavir treatment during 01jan2011 to 30dec2013 * age \<18 years old on the date starting an atazanavir-containing regimen * have a minimum of 3 months of follow-up
a study of child injury based on data mining

Conditions: Injuries; Child

Summary: a comprehensive pediatric injury burden assessment is an essential foundation for formulating injury prevention strategies and improving emergency care for injured children. although the hospital-based passive surveillance of national injury surveillance system of medical and health institutions has been well-established in china, the monitoring points of hospitals were not stratified according to children's hospital. aim of the project is to collect epidemiological and clinical data to describe causes, clinical features and outcomes of pediatric injuries at a children's hospital in shanghai, china. the project intends to establish a method for collecting and analyzing high quality data of child injury using data mining based on the hospital information system.

injuries are a leading cause of death for infants and children around the world. according to the haddon injury control model, 90 percent of injuries are both predictable and preventable. injuries are preventable, not "accidents". all unintentionally and intentionally injured children first visit to the emergency department are recruited in the study. children's hospital of fudan university with a regional pediatric trauma centre is also the first pediatric injury prevention center established in china. we conduct a prospective cohort study to investigate the epidemiology, clinical course, and outcomes of the injured child first visit to the emergency department, which expected to serve as evidence of injury prevention and promising practices. in the study, we collect and analyze high quality data of child injury based on data mining.

Eligibility criteria:
inclusion criteria: all pediatric patients between the ages of 0-18 years newly diagnosed with injuries in the emergency department，and recorded icd-10 diagnosis codes from v01 to x39 exclusion criteria: patients who were dead on arrival to the emergency department are not included.

Keywords: injuries child epidemiology
efficacy and safety of amphotericin b and azoles in the treatment of invasive fungal disease

Conditions: Invasive Fungal Disease

Summary: efficacy and safety of amphotericin b and azoles in the treatment of invasive fungal disease

the medical records, demographic characteristics and clinical data of patients with invasive fungal disease treated with amphotericin b or azoles were collected through the electronic medical record system of sichuan provincial people's hospital from 2021 to 2024. to evaluate the efficacy and safety of these two types of drugs.

Eligibility criteria:
inclusion criteria: * there is no age limit, gender is not limited * patients with invasive fungal disease who are treated with polyene antifungals or azole antifungals should be treated for ≥ 7 days. exclusion criteria: * patients with incomplete data or other factors affecting the clinical outcome judgement * patients who are judged by the investigator to be unsuitable to participate in this study.