Kornimate/medical-research-clean huggingface dataset:
the dutch asymptomatic mitral regurgitation trial

Conditions: Heart; Disease, Mitral(Valve); Diseases of Mitral Valve; Mitral Valve Insufficiency

Summary: the purpose of this study is to compare early mitral valve repair versus a watchful waiting strategy in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.

severe asymptomatic organic mitral valve (mv) regurgitation with preserved left ventricular (lv) function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and conflicting, which is reflected in current guidelines. european guidelines advocate a more conservative strategy i.e. watchful waiting, with yearly echocardiography, whilst american guidelines are more in favour of early surgery to reconstruct the mv, i.e. mv repair (in contrast to mv replacement) in order to prevent future lv dysfunction and complaints. a number of non-randomised trials show a favourable outcome of early surgery and the early surgery strategy has shown to be associated with improved long-term survival, decreased cardiac mortality and decreased morbidity compared with the conservative management \[citations 1-3\]. on the other hand, non-randomised trials describe also that a conservative strategy (i.e. watchful waiting) can be safely accomplished. if facilitated surgery is performed in this population it has proven to be eventually associated with good perioperative and postoperative outcome in 50% of the patients at 10 years when careful follow-up is being carried out \[citation 4\]. non-randomised trials inherently have a number of drawbacks. a randomised trial comparing both strategies and objectivising the best treatment strategy has never been performed. the dutch amr (asymptomatic mitral regurgitation) trial is a multicenter, prospective, randomised trial comparing early mv repair versus watchful waiting in asymptomatic patients with severe organic mv regurgitation and preserved lv function \[citation 5, 6\].

Eligibility criteria:
inclusion criteria: * asymptomatic * severe organic mitral valve regurgitation. * preserved left ventricular function (left ventricular ejection fraction \>60% and left ventricular end-systolic dimension ≤45 mm) * the likelihood of mv repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon exclusion criteria: * pulmonary hypertension (\>50 mmhg at rest) * atrial fibrillation * physical inability as determined by the heart team to undergo surgery * other life-threatening morbidity * higher expected surgical risks in advance, according to the dedicated heart team * moderate to severe kidney disease (egfr less than 30 ml/min) * flail leaflet together with a left ventricular end systolic diameter (lvesd) \>40 mm

Keywords: mitral valve insufficiency mitral valve regurgitation asymptomatic mitral valve regurgitation asymptomatic mitral valve insufficiency mitral valve repair watchful waiting
trial of otd70derm® in radio-dermatitis induced by radiotherapy-erbitux®

Conditions: Head and Neck Carcinoma

Summary: the aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (nci-ctc v3.0) in patients receiving radiotherapy+erbitux+placebo versus in patients receiving radiotherapy+erbitux+otd70derm® for the treatment of head and neck carcinoma.


Eligibility criteria:
inclusion criteria: * head and neck carcinoma treated by radiotherapy (70gy) plus erbitux exclusion criteria: * imrt; concomitant chemotherapy

Keywords: head and neck carcinoma treated by radiotherapy plus erbitux
genetic mapping of atherogenic lipoprotein phenotypes

Conditions: Atherosclerosis; Cardiovascular Diseases; Heart Diseases

Summary: to map the major gene influencing low-density lipoprotein subclass phenotypes, denoted atherogenic lipoprotein (alp) phenotypes, with a long term goal of cloning the alp gene and understanding its role in genetic susceptibility to atherosclerosis.

background: alp phenotype b (alp-b), characterized by a predominance of small, dense ldl particles as determined by gradient gel electrophoresis, has been associated with increased risk of myocardial infarction and a constellation of atherogenic lipid and apolipoprotein (apo) changes. based on complex segregation analysis, alp-b appeared to be influenced by a single major genetic locus with a dominant mode of inheritance and a common allele frequency. this project was designed to identify a new gene involved in susceptibility to coronary heart disease. design narrative: the investigators identified, collected and constructed a repository of immortalized cell lines and lipid and apo measurements from members of families informative for alp. they tested genes implicated in lipoprotein metabolism as possible candidate alp genes and used highly informative dna probes to search the genome for linkage to the alp gene. they also refined the model for the inheritance of alp phenotypes and tested for genetic-environmental interactions. forty informative families were recruited for the repository. the families were identified through two sources of probands: former participants in a cholesterol-lowering diet study and patients seen at the lipid clinics at the university of washington. each participating family member completed a medical history questionnaire and provided a blood sample for alp phenotype determination, for dna studies, and for lipid and apo measurements. linkage studies and lod score analyses began with a candidate gene approach, and continued by using dna probes that revealed restriction fragment length polymorphisms (rflps) to search the genome for linkage to the alp gene. when a linkage was found, alp genotype information was used to refine the statistical model describing the inheritance of alp phenotypes, and to evaluate genetic-environmental interactions involving lipid and apo levels and environmental and behavioral factors.

Eligibility criteria:
no eligibility criteria
albumin and prognosis of severely patients burns

Conditions: Severe Burn

Summary: hemodynamic management has long been identified as a key factor affecting burn prognosis. however, large amounts of crystalloid infusion have been associated with the development or aggravation of organ failure (acute respiratory distress syndrome, vascular injury, acute renal failure, and intra-abdominal hypertension) which worsens the final prognosis. the use of albumin during the first 24 hours of burn resuscitation is controversial since capillary leakage may cause transcapillary passage of large molecules into the interstitial space. in fact, human albumin has multiple physiological effects, including regulation of colloidal osmotic pressure, antioxidant properties, nitric oxide modulation and buffering capacities, plasma binding and transport of various substances, which may be particularly important in severe burns. currently available data suggest that administration of exogenous albumin during the first 24 hours of resuscitation of severe burn patients may be associated with improved outcomes. multi-centre randomized controlled trials with adequate power should be undertaken in burned patients.

in the participating centers: severe burn adult patients with a tbsa burn \>30% will be included and followed for 90 days after admission. this observational study will allow us to collect and analyze data in order to design a quality interventional trial evaluating the value of albumin in the initial management of the severely burned patient. the primary objective of the study is to describe the incidence of a combined endpoint of mortality, severe acute renal failure (stage 3) and severe acute respiratory distress syndrome in severely burned patients. secondary objectives 1. describe the prognosis of patients with severe burns, with particular emphasis on the impact of albumin on the prognosis of patients with severe burns. 2. describe how albumin is administered (i.e. doses, duration of treatment, continuous vs. bolus administration, hyperoncotic vs. hypooncotic solutions, etc.).

Eligibility criteria:
inclusion criteria: * patients over 18 years of age * burns \> 30% sct * patients admitted to the icu within 12 hours of a burn. exclusion criteria: * pregnancy * patients with a limitation of active therapeutics on admission to bicu * pre-hospital cardiac arrest * moribund patients: pre-hospital cardiac arrest, cbs burn \>95%. * age \>80 years

Keywords: severe burn acute respiratory distress acute kidney injury albumin
a/h1n1 immunogenicity and safety in adults

Conditions: Influenza; Pandemic Influenza

Summary: the purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational h1n1 pandemic influenza vaccine in healthy adults 18 years of age and older.


Eligibility criteria:
inclusion criteria: * subject is 18 to 59 years old (age stratum a) or 60 years of age or older (age stratum b) at the time of screening * subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry * subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination * subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary * if female of childbearing potential, subject has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study exclusion criteria: * subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study * subject has a history of exposure to a/h1n1/california/07/2009 virus or a history of vaccination with a/h1n1/california/07/2009 antigen or a closely related influenza virus antigen * subject has inherited or acquired immune deficiency * subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
detection of micrometastases in lymph nodes of patients with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to set up a model for detecting micrometastases in lymph nodes of patients with prostate cancer by quantitative polymerase chain reaction and its impact on progression-free survival.


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate cancer * locally operable tumor * negative bone scan (obligatory if gleason score \> 7 or psa \> 20ng/ml * karnofsky ≥ 80% * age 18 - 75 years * informed consent in written form * sufficient hematologic, coagulatory and renal function * compliant patient and geographic precondition for adequate follow-up given exclusion criteria: * manifest secondary tumor * organ metastases on ct-scan /mri or in histology * myocardial infarction or stroke within the last 6 months * severe cardiovascular (grade iii - iv according to nyha), pulmonary (po2 \< 60 mmhg), renal, hepatic oder hematopoetic impairment * severe active or chronic infection (z.b. pos. hiv-antibody-test, hbs-ag-detected in serum and/ or chronic hepatitis) * severe psychiatric disease * previous chemotherapy * previous pelvine radiotherapy

Keywords: prostate cancer lymph node micrometastasis
thickness of the plantar fascia in stretched and relaxed positions in patients with plantar fasciopathy

Conditions: Plantar Fasciopathy

Summary: this study will compare the thickness of the plantar fascia in stretched and relaxed positions in patients with plantar fasciopathy using ultrasonography.

the purpose of this observational study is to compare the thickness of the plantar fascia in stretched and relaxed positions of the most symptomatic heel in patients with plantar fasciopathy using ultrasonography. in addition to this, we will compare measurements of the thickness of the plantar fascia in sagittal versus transversal transducer positions, compare pressure pain thresholds at the most tender spot of the plantar fascia in stretched and relaxed position using pressure algometry and investigate the association between the thickness of the plantar fascia and the pressure pain threshold. all measurements are performed bilaterally starting with the most symptomatic foot. to compare thickness and pressure pain thresholds in stretched and relaxed positions of the plantar fascia paired-t-tests are used. to compare the most and least symptomatic sides paired-t-tests will be used. the association between the thickness of the plantar fascia and pressure pain threshold will be investigated using the pearson's correlation coefficient.

Eligibility criteria:
inclusion criteria: * history of plantar heel pain of at least 3 months * clinical presentation of pain and/or tenderness to palpation in the area of the medial tubercle of the calcaneus * average intensity of pain in the previous week equal to or greater than 3 on an 11-point visual analog scale (vas) * thickness of symptomatic plantar fascia of 4 mm or greater exclusion criteria: * age under 18 * pregnancy * history of systemic disease with manifestations similar to those of plantar fasciopathy * pain medication in the last 24 hours * steroid injection for plantar fasciopathy in the previous 6 months * previous heel surgery or fracture of the lower leg or foot

Keywords: plantar fasciitis plantar heel pain
special drug use investigation of xarelto for venous thromboembolism (vte)

Conditions: Venous Thromboembolism

Summary: the objective of this investigation is to assess safety and effectiveness of xarelto under practice routine use in vte secondary prevention after acute dvt, focusing on hemorrhagic-related aes, recurrent venous thromboembolism (pe/dvt), all-cause mortality. this study is a company sponsored, one- arm prospective cohort study with patients to whom rivaroxaban treatment for vte (pe/dvt) has been chosen. the study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).


Eligibility criteria:
inclusion criteria: - patients who start rivaroxaban for vte(pulmonary embolism, deep vein thrombosis) anticoagulation therapy. exclusion criteria: - patients who are contraindicated based on the product label and have already received xarelto treatment.

Keywords: xarelto, rivaroxaban, vte, pe, dvt, japan, pms, sdui
pharmacokinetic characterization of the hemophilia a population in spain using mypkfit®

Conditions: Hemophilia A; Hemophilia; Factor VIII Deficiency

Summary: the purpose of this study is to describe the pharmacokinetic profile of patients with hemophilia a in prophylaxis in spain using mypkfit®

this pharmacokinetic profile will be obtained in only in patient using advate® (inn-octocog alfa) or adynovi® (inn- rurioctocog alfa pegol), both recombinant intravenous fviii products, with mypkfit®. this patients will be followed during the period of 12 months, and the pharmacokinetic will be measured collecting at least 2 blood samples, in which the presence of factor viii will be determined by the usual clinical methods: chromogenic method or coagulative method.

Eligibility criteria:
inclusion criteria: * male patients. * age between 1 and 65 years old. * patients diagnosed with hemophilia a who are on prophylactic treatment with advate® or adynovi® or adjusted with mypkfit. * patients older than 18 who have signed the informed consent form. * in the case of mature minors, in addition to the consent signed by the legal guardian, an assent of the minor must be obtain. * in the case of patients legally incapable for giving their consent, their primary caregiver will consent as the patient's legal guardian. exclusion criteria: * withdrawal of informed consent. * patients with any medical or psychological condition that according to the researcher's criteria prevents them from following the usual clinical practice procedures. * patients with concomitant diagnosis of other haemostasis disorders. * patients being treated for induction of immunologic tolerance at the time of inclusion.

Keywords: hemophilia hemophilia a factor viii advate antithrombotic factor pharmacokinetic dosing hemarthrosis mypkfit
an incitative multifaceted procedure for pneumococcal vaccination at the emergency department

Conditions: Pneumococcal Infections

Summary: background : community-acquired pneumonia (cap) is a threat in industrialized countries. it represents the 6th cause of death. cap also frequently associates with other disorders responsible for admission and death. among bacteria responsible for cap, streptococcus pneumonia is a major pathogen that is commonly involved and frequently leads to severe infection and admission. categories at risk for this pathogen have been determined, and can be proposed anti-pneumococcal vaccination (apv) that efficiently and safely protects from this microorganism. in the context of us health services, monocenter pilot experiences have reported improvement of pneumococcal prophylaxis implementing vaccination procedure at ed. a study that set in new mexico (2003) reported a significant increase in apv (from 18% to 84%) when patients at risk were proposed vaccination at ed. to obtain these results, medical students were specifically trained and dedicated to screen and vaccinate against st. pneumoniae. another single center trial (tennessee, 2007) for apv at ed obtained an improvement (from 38.8 to 45.4%) when physicians were alerted for pneumococcal risk by the software they usually utilized at bedside. however these experiences remain sparse as additional dedicated resources are required or patients and attending ed physicians can be reluctant to proceed to vaccination at ed. mobile phone and derived communication modalities are current vectors to deliver information in several fields including education and medicine. initially used in developing countries, short-message services (sms) have improved behaviour of patients in various medical areas. in france, the investigators have observed that most patients above 50 years of age admitted after ed visit are equipped with mobile phone and can receive alerts by sms. these observations prompt us to propose a multifaceted procedure to improve apv after ed visit in at-risk patients, combining structured oral interview, written information and sms as reminders. purpose : the investigators hypothesized that * a multifaceted intervention to promote anti-pneumococcal vaccination combining a structured oral interview, a written information to patient and his/her general practitioner, and a series of 3 sms, * improves anti-pneumococcal vaccination at 6 months, * in at-risk patients (65+ years) visiting the emergency department. in order to answer this question, the investigators designed an interventional prospective multicenter randomized study (cluster).


Eligibility criteria:
inclusion criteria: * patients 65-year old and above, * benefit from french or monaco social security a social security. exclusion criteria: * refuse to participate, * no possibility to receive sms, * impaired cognitive functions and mental status precluding understanding of the study, * anticipated barriers precluding adequate follow-up (ex. homeless), * previous apv, * contraindication to apv, * do not understand/read french.

Keywords: anti-pneumococcal vaccination information emergency department
convolutional neural network model to detect coronavirus disease 2019 (covid-19) pneumonia in chest radiographs

Conditions: COVID-19 (Coronavirus Disease 2019); COVID-19 Pneumonia

Summary: this study aims to design a convolutional neural network (cnn) and apply an attention model to help differentiate pneumonia due to severe acute respiratory syndrome coronavirus 2 (sars-cov-2), pneumonia due to other viruses/bacteria, and normal chest x-ray (cxr) in clinical practice. a bank of digital chest images from a high-complexity health facility in cali, colombia, was used.

to differentiate coronavirus disease 2019 (covid-19) pneumonia from other types of pneumonia, expert radiologists must analyze the chest x-ray (cxr) to identify visual, radiographic patterns associated with severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection. it is challenging because the findings are similar for different types of pneumonia. since the manual diagnosis of covid-19 from cxr is a difficult and time-consuming process, applying deep learning (dl) models to medical image analysis is a current hot research topic. this work will develop a new convolutional neural network (cnn) to detect covid-19 radiographs. it will use a large dataset of chest radiographs classified into three classes: viral/bacterial pneumonia, covid-19 pneumonia, and normal images. the study aims to incorporate a new attention module that applies cnns to the linear projection operation to help differentiate covid-19 pneumonia from other pneumonia and normal chest radiographs in clinical practice.

Eligibility criteria:
inclusion criteria: * chest radiographs from patients without covid-19 or other pneumonia took before the pandemic start date (january 2020) * chest radiographs from patients with covid-19 confirmed by positive reverse transcriptase polymerase chain reaction (rt-pcr) and/or presence of antibodies to covid-19 and/or positive covid-19 viral antigen. * chest radiographs from patients without covid-19 confirmed by a negative reverse transcriptase polymerase chain reaction (rt-pcr) and other pneumonia diagnoses taken before the pandemic start date (january 2020) exclusion criteria: * n/a

Keywords: covid-19 (coronavirus disease 2019) diagnostic imaging radiography thorax computer neural network deep learning