Kornimate/medical-research-clean huggingface dataset:
comparative effectiveness of prophylactic icd versus non-icd therapy

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the investigators aim to compare the risk of mortality of non-implantable carioverter defibrillator (icd) vs. icd management in patients with heart failure with reduced ejection fraction (hfref).

the proposed contemp-icd trial is a prospective, multicenter, open-label, randomized controlled trial; enrolling 3290 participants with hfref, on stable and optimal guideline-directed medical therapy (gdmt), who are eligible for a primary prevention icd, but have a low predicted arrhythmic risk. enrolled participants will be randomized in a 1:1 ratio to non-icd vs. icd treatment arms. the investigators hypothesize that, in participants with hfref who have a low predicted arrhythmic risk, non-icd vs. icd is non-inferior with respect to the primary endpoint of all-cause mortality and superior survival free of major cardiovascular (cv) events. this study will recruit adults 18 years of age and older with heart failure. participants will be asked to complete questionnaires. information from medical records will be gathered including medical history, physical exam, medications, blood work results, and imaging. visits will be at initial, three, six months, and every six months beyond six months. for those who get an icd device an interrogation will be collected at the visits.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years (no upper limit) * class i or iia indication for a primary prevention icd15: ischemic or non-ischemic cardiomyopathy and nyha class ≥ ii if most recent lvef is ≤ 35% or ischemic cardiomyopathy with nyha class i if most recent lvef is ≤ 30% * most recent lvef (%) obtained per cardiac imaging obtained at any time prior to enrollment after being stable on optimal gdmt\*\* for at least one month * stable optimal gdmt at least one calendar month prior to last cardiac imaging test, prespecified as one of the following for at least 1 calendar month prior to study randomization: receiving all 4 therapy classes (beta-blockers, arni/arb/ace, mra and sglt2i) or gdmt score ≥ 6 (per figure 7) • madit-icd benefit score \< 50 (per figure 4) exclusion criteria: * existing icd/crt-d * • planned crt-p or crt-d implant for any indications including class i or iia indication for crt: presence of left bundle branch block (lbbb) with qrs ≥ 120 msec or qrs duration ≥ 150 msec regardless of qrs morphology or decision for crt implant by ep provider for other indications * acute mi within the past 3 calendar months * chronic renal failure requiring hemodialysis * coronary revascularization within the past 3 calendar months * history of sustained vt or vf * known genetic cause of cardiomyopathy * life expectancy \< 1 year * unable or unwilling to follow study protocol * inability to consent

Keywords: implantable cardioverter defibrillator sudden cardiac death guideline directed medical therapy
international alfapump cohort study

Conditions: Liver Cirrhoses; Malignant Ascites

Summary: this registry is designed to follow patients who have been implanted with an alfapump system, which is a newly marketed product from sequana medical ag, a swiss medical device company.

in a real-world setting, all patients implanted with an alfapump system according to it's intended use, not participating in another clinical study in which the alfapump is studied.

Eligibility criteria:
inclusion criteria: * all patients implanted with an alfapump are eligible for this registry exclusion criteria: * patients younger than 18 years * pregnancy * inability to operate the smart charger to recharge the alfapump * participating in another study in which the alfapump is studied
comparison of 30-day morbidity and mortality in cancer patients based on emergency department location

Conditions: Cancer; Cancer Remission

Summary: patients being followed for cancer account for 2.8% of emergency admissions in france. an acute episode that triggers a visit to the emergency department may be related to the progression of the disease, or to complications of treatment. the management of these patients is often complex and requires a degree of expertise. emergency departments specialising in the management of cancer complications have been set up, and now deal exclusively with patients treated at their centres. however, for geographical or logistical reasons, patients with cancer are likely to consult a non-specialist emergency department and/or one located outside the cancer care centre. in this case, the emergency doctor may not have access to the oncology file, and care in the emergency department and downstream services may be sub-optimal. studies have shown a positive impact on the quality of care and prognosis of patients thanks to the cancer centre's expertise. however, the effect of the centre on a cancer patient who visits the emergency department has never been studied. this is particularly true if the emergency department where the patient is seen is located in the cancer follow-up centre. the primary objective of the cover study is to investigate the impact of the location of the emergency department where the patient is seen for their prognosis.


Eligibility criteria:
inclusion criteria: patients aged 18 or over admitted to an emergency department with cancer that has been active or in remission for less than a year. exclusion criteria: - opposition to participate in the study

Keywords: emergency department cancer mortality morbidity and mortality in cancer
deformity of the forefoot in children with unilateral cerebral palsy

Conditions: Forefoot Adductus; Cerebral Palsy

Summary: midfoot and backfoot deformities are well described in children with cerebral palsy. however, data regarding forefoot deformities in cerebral palsy remain scarce in a population were foot deformities are the most frequent musculo-skeletal deformities.

foot deformities are the most frequent musculo-skeletal deformities in children with cerebral palsy. pain starts in the foot, especially during gait in cerebral palsy children (gmfcs i and ii) and induce gait limitations, balance disorders, wounds, aesthetic disorders and difficulties to support shoes. metatarsus adductus is the most common foot deformity in children with or without disorder, occuring on 1-2/1000 births. in 4 to 14% of the children, evolution is not favorable at 5 years. in that case, the diagnostic of cerebral palsy have to be considered.

Eligibility criteria:
inclusion criteria: * child who benefit a standardised clinical evaluation before a 3d gait analysis with forefoot deformity measure * child age less than 18 years old * child with left or right unilateral cerebral palsy * walking child ( gmfcs score i, ii or iii) * in case of several 3d gait analysis for the child: the 3d gait analysis was chosen first before any local spasticity treatment with botulinic toxin injection or the 3d gait evaluation the more far from local spastica treatment with botulinic toxin injection was chosen in second . exclusion criteria: * hemiplegia due to another etiology * history of lower limb or foot surgery before the clinical evaluation * local spasticy treatment with botulinic toxin injection less than 3 months before the clinical evaluation * participation refusal

Keywords: cerebral palsy forefoot deformity
neoadjuvant folfirinox regimen in patients with non-metastatic pancrease cancer

Conditions: Pancreas Cancer; Localized Pancreas Cancer; Non-metastatic Pancreas Cancer

Summary: a prospective evaluation of neoadjuvant folfirinox regimen in patients with non-metastatic pancreas cancer (baylor university medical center and texas oncology experience)

patients with pancreas cancer will be enrolled and treated with a planned course of 6 cycles (3 months) of chemotherapy with folfirinox prior to undergoing surgical resection.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * male or non-pregnant and non-lactating female * histologically or cytologically confirmed adenocarcinoma of pancreas * patients must have satisfactory blood counts and blood chemistry levels at baseline (refer to appendix 2, study laboratory references range). * patient has eastern cooperative oncology group(ecog) performance status 0 to 1 (refer to appendix 7): * 0 - asymptomatic (fully active, able to carry on all predisease activities without restriction) * 1 - symptomatic but completely ambulatory (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. for example, light housework, office work) * signed study consent form exclusion criteria: * \<18 years of age * pregnant or lactating female * patient has islet cell neoplasms * patient has known brain metastases * patient has metastatic disease * active secondary malignancies * active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * known infection with hepatitis b, hepatitis c, or cirrhosis * major surgery or vascular device placement (excluding ports for iv medication/chemotherapy) within 2 weeks prior to day 1 of treatment in study * prior chemotherapy or radiation for pancreatic cancer * history of allergy or hypersensitivity to the study drugs * patient is enrolled in any outside (outside baylor university medical center or texas oncology) clinical protocol or investigational trial * significant cardiac disease as defined as new york heart association (nyha) classification iii or iv, uncontrolled congestive heart failure (chf), or prior myocardial infarction (mi) last 6-months * any prior gastrointestinal (gi) disease or history of prior pelvic or abdominal radiation which in the opinion of the investigator may place the patient at increased risk * peripheral sensory neuropathy ≥ to grade 2 at baseline * significant co-morbidities deemed by investigator as unsuitable for participation/enrollment * study consent form not signed

Keywords: non-metastatic pancreas cancer pancreatic cancer cancer of pancreas adenocarcinoma of pancreas neoadjuvant
systematic oral education for prevention of oral-related complications caused by radiotherapy for head and neck cancer

Conditions: Malignant Tumor of Head And/or Neck; Radiotherapy; Complications

Summary: a study on the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors

the goal of this clinical trial is to investigate the efficacy of systematic oral health education for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. the main question it aims to answer is: the efficacy of systematic oral health education for the prevention oral-related complications caused by radiotherapy for head and neck malignant tumors participants will: be given systematic oral health education or routine oral health education be evaluated to learn the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors researchers will compare systematic oral health education group with routine oral health education group to see if systematic oral health education has good efficacy for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors.

Eligibility criteria:
inclusion criteria: * patients diagnosed with malignant tumors of the head and neck without metastasis * age ≥18, ≤80 years old * zps score ≤2 * receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of \>50 gy * signed informed consent form exclusion criteria: * patients with oral mucositis due to allergic reactions to certain foods, medications, or oral care products * have a history of head and neck radiotherapy * poor oral hygiene or severe periodontitis * poor compliance * other patients who, in the opinion of the investigator, are not suitable for participation in this study
noninvasive pulse contour analysis for hemodynamic assessment in patients with chronic heart failure

Conditions: Heart Failure

Summary: determination of hemodynamics plays an important role in the diagnosis of chronic heart failure. the gold standard is intermittent thermodilution via pulmonary artery catheter (pac). because of its invasiveness, there are certain risks of this method, e.g. injuries to the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc. noninvasive pulse contour analysis (npca) is a new method which is able to determine hemodynamics noninvasively via a simple finger cuff. advantages towards pulmonary artery catheterization include a lower risk and an operator-independent easy handling. some studies investigated the accuracy, precision and trending abilities of noninvasive pulse contour analysis during anesthesia and in the intensive care unit, but there is no data available for its use in patients with chronic heart failure. the investigators therefore initiated this trial to verify if npca is suitable for determination of hemodynamics in patients with chronic heart failure.

determination of hemodynamics plays an important role in the diagnosis of chronic heart failure. the gold standard is intermittent thermodilution via pulmonary artery catheter (pac). because of its invasiveness, there are certain risks of this method, e.g. injuries to the nerves and vessels, excessive bleedings, pneumothorax, cardiac arrhythmias etc. noninvasive pulse contour analysis (npca) is a new method which is able to determine hemodynamics noninvasively via a finger cuff. advantages towards pulmonary artery catheterization include a lower risk and an operator-independent easy handling. some studies investigated the accuracy, precision and trend abilities of noninvasive pulse contour analysis during anesthesia and in the intensive care unit, but there is no data for its use in patients with chronic heart failure. the investigators therefore initiated this trial to verify if npca is suitable for determination of hemodynamics in patients with chronic heart failure. for npca the investigators use the cnap monitor (cnsystems medizintechnik ag). as a reference method the investigators use intermittent thermodilution via pac (td). three averaged autocalibrated npca-co-measurements are going to be validated against three averaged td-co-measurements. moreover, measurements of cardiac index, stroke volume, systemic vascular resistance and a between-calibration-drift will be performed. the investigators will assess the accuracy and precision of the individual values.

Eligibility criteria:
inclusion criteria: * chronic heart failure nyha \>= 2 based on a reduced left ventricular ejection fraction (lv-ef \<= 45%) * written consent exclusion criteria: * high-grade tricuspid insufficiency * implantation of a ventricular assist device (vad) * nibp difference \>= 20 mmhg between left and right arm before investigation

Keywords: hemodynamics noninvasive pulse contour analysis heart failure swan ganz catheterization pulmonary artery catheter
l-arginine and antioxidant vitamins during pregnancy to reduce preeclampsia

Conditions: Pre-Eclampsia

Summary: this study is intended to assess the efficacy of l-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population.

preeclampsia is a syndrome of unknown origin characterized by hypertension, edema and proteinuria. it usually appears in the third trimester and occurs most frequently in primigravidas. preeclampsia may be complicated by life-threatening conditions including seizures, severe hepatic dysfunction, renal failure and coagulopathy; it is one of the leading causes of maternal morbidity and mortality worldwide. preeclampsia is cited as the leading cause of maternal death in surveys of maternal mortality in mexico (25% of maternal deaths). specific aim 1. to assess the efficacy of l-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population. two other groups will receive the food (bars) either with antioxidant vitamins alone or without vitamins in order to test the impact of vitamin supplements on prevention of preeclampsia. the primary hypothesis to be tested is that supplemental l-arginine in combination with antioxidant vitamins will significantly reduce preeclampsia (hypertension and proteinuria) and its complications in a high-risk population (women whose blood pressure is \> 140/90 after 20 weeks gestation without proteinuria). secondary hypotheses to be tested include that antioxidant vitamin supplementation contributes to the reduction in preeclampsia; that supplemental l-arginine and antioxidant vitamins will improve neonatal outcomes (reduced incidence of prematurity and intrauterine growth retardation); that preeclampsia is correlated inversely with plasma l-arginine levels, directly with the plasma levels of the endogenous no synthase inhibitor, asymmetric dimethyl arginine (adma), and inversely with urinary no metabolites, a marker of endogenous no production; and that preeclampsia is inversely correlated with maternal plasma levels of antioxidant vitamins.

Eligibility criteria:
inclusion criteria: * previous pregnancy complicated with pre-eclampsia/eclampsia * singleton pregnancy * gestational age \>20 weeks \<34 weeks * protein excretion \< 300 mg/day exclusion criteria: * multiple gestation * major fetal anomaly * pre-existing hypertension * pre-existing renal disease * diabetes * collagen vascular disease * cancer or strong family history of cancer in first degree relatives * preexisting maternal disease requiring medication

Keywords: pre-eclampsia hypertension,pregnancy-induced preterm labor
efficacy and safety study of benralizumab added to medium-dose inhaled corticosteroid plus laba in patients with uncontrolled asthma

Conditions: Asthma

Summary: the purpose of this study is to determine whether benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ics-laba.


Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures 2. female and male aged from 18 to 75 years, inclusively 3. history of physician-diagnosed asthma requiring treatment with medium dose ics (\>250ug fluticasone dry powder formulation equivalents total daily dose) and a laba, for at least 12 months prior to visit 1 4. documented treatment with medium-dose ics (\>250ug and ≤500ug fluticasone dry powder formulation equivalents total daily dose) and laba for at least 3 month prior to visit 1 exclusion criteria: 1. clinically important pulmonary disease other than asthma (e.g. active lung infection, copd, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, churg- strauss syndrome, hypereosinophilic syndrome) 2. any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could: - affect the safety of the patient throughout the study - influence the findings of the studies or their interpretations - impede the patient's ability to complete the entire duration of study 3. acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study

Keywords: asthma, bronchial diseases, respiratory tract diseases, lung diseases, obstructive lung diseases
validation of the efficacy of the tool gimias® for the assessment of left atrial fibrosis in a group of healthy volunteers (restore-hv)

Conditions: Left Atrial Fibrosis

Summary: the purpose of this study is to validate the technique for the detection of left atrial fibrosis through segmentation of endocardial and epicardium landmarks of the images obtained with 3 tgadobutrol-enhanced magnetic resonance with the software gimias® in a cohort of healthy volunteers, without atrial fibrillation or known cardiovascular risk factors.

3d reconstructions obtained by gimias® will be evaluated. processing images will be carried out by two independent operators, and will calculate the kappa interobserver agreement . subsequently, the processed images are compared with images previously obtained in 10 patients with persistent atrial fibrillation adjusted for sex and age. a qualitative visual comparison will be made.

Eligibility criteria:
inclusion criteria: * healthy volunteers capable of being subjected to the prespecified tests of the study. * healthy volunteers that sign the informed consent after being informed. exclusion criteria: * healthy volunteers with: * a medical history of atrial fibrillation, hypertension or diabetes mellitus. * a medical history of heart disease, structural, ischemic or arrhythmic. * a medical history of chronic obstructive pulmonary disease/obstructive sleep apnoea/hypopnoea syndrome * sport habits: intense sport activities during three or more hours in a week * any assumption that contraindicates the magnetic resonance and/or the use of gadolinium or other contrast mediums, including a medical history of previous allergic or not allergic reactions with the use of gadolinium or other contrast mediums, bronchial asthma or allergic diseases. * pregnancy or breast feeding.

Keywords: segmentation gimias® program atrial fibrillation left atrial fibrosis healthy volunteers
last 3 months of life in home ventilated patients

Conditions: Respiratory Failure

Summary: to verify with a specific questionnaire, the families' perceived quality of end-of-life care and of dying in the last 3 months of life of 168 patients (chronic obstructive pulmonary disease-amyotrophic lateral sclerosis (als)-restrictive disorders-neuromuscular disease- others) with chronic respiratory failure needing domiciliary mechanical ventilation (mv).

participants: 168 patients' relatives presenting five categories of diseases (chronic obstructive pulmonary disease-amyothrophic lateral sclerosis (als)-restrictive disorders-neuromuscular disease- others) answered to questionnaire. interventions: none measurements and main results: 35 questions grouped in 6 specific domains (control of pain and symptoms (domain 1-d1), awareness of disease (d2), family burden (d3), the process of dying (d4), medical troubles including hospitalizations (d5) and technical problems linked to mv(d6) were asked after the patient's death to a family member by means of a face to face interview. answers to the binary 35-item questionnaire were distributed into just two clusters per each domain.

Eligibility criteria:
inclusion criteria: all patients mechanically ventilated at home who died exclusion criteria: patients with cancer

Keywords: ethics copd end of life mechanical ventilation crf home ventilated patients