Kornimate/medical-research-clean huggingface dataset:
multicenter registry on microvascular dysfunction - searching a new ach spasm definition

Conditions: Coronary Microvascular Disease; Coronary Vasospasm

Summary: the micro-snape registry will collect data from patients undergoing investigation of microvascular dysfunction and coronary spasm in europe and north america.

microvascular dysfunction is an important determinant of patients´quality of life and prognosis, which however remains poorly classified. given the high burden of disease and the severity of the functional impairment in these patients, the lack of a clear understanding and diagnosis has a potentially large clinical importance. it is therefore important to better describe the phenotype of these patients. the micro-snape registry will allow investigating these associations. patient data as collected during the local clinical practice and at the operator's discretion, will be retrospectively entered in this non-interventional registry in anonymous form.

Eligibility criteria:
inclusion criteria: * patients who underwent combined measurements of coronary pressure and flow in at least 1 native coronary artery in response to endothelium dependent and independent vasodilators. exclusion criteria: * hemodynamic instability * age \<18 years
bez235 trial in patients with her2-(human epidermal growth factor receptor 2 negative) /hr+ (hormonal receptor positive) metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this is a prospective, multi-center, open-label, single arm, phase ii study with a 2-stage design and bayesian interim monitoring to investigate the safety and efficacy of bez235 in patients with progressive metastatic hr+ her2- breast cancer who have received at least one prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic disease. patients will be stratified into 3 groups according to their pi3k (phosphatidylinositol 3-kinase) pathway activation status.


Eligibility criteria:
inclusion criteria: * female ≥ 18 years * ecog performance status ≤ 2 * histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and her2 negative) * known pi3k activation status (defined by pik3ca (phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and pten pten (phosphatase and tensin homolog) mutation/expression) * prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer * objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per recist * adequate bone marrow and organ function exclusion criteria: * previous treatment with pi3k and/or mtor inhibitors * symptomatic central nervous system (cns) metastases * concurrent malignancy or malignancy in the last 5 years prior to start of study treatment * wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug * active cardiac disease (e.g. left ventricular ejection fraction (lvef) \ 480 msec on screening ecgelectrocardiogram (ecg), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias) * inadequately controlled hypertension * impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bez235 * treatment at start of study treatment with drugs with a known risk to induce torsades de pointes, moderate and strong inhibitors or inducers of isoenzyme cyp3a4, warfarin and coumadin analogues, lhrh agonists * history of photosensitivity reactions to other drugs * pregnant or nursing (lactating) woman other protocol-defined inclusion/exclusion criteria may apply

Keywords: metastatic breast cancer her2 negative hr positive pi3k pathway no more than 2 prior lines of chemotherapy metastatic breast cancer(mbc)
continuous deep sedation until death

Conditions: Terminal Care

Summary: this research is a descriptive observational study conducted in multicenter (intensive care and continuing care units) in france. all data collected is part of the patient record. the main objective is to describe the end-of-life sedative practices following a decision to limit or stop therapy in intensive care unit and continuing care unit.

all participating sites will include last 10 consecutive major patients deceased following a decision to limit or stop therapeutics. the study include only data from patients died before january 1, 2020. in the case report form the following information will be entered: * the characteristics of the unit of intensive care or continuing care unit. * patient characteristics * characteristics of sedative practices

Eligibility criteria:
inclusion criteria: * adult patients at the time of death (\>18years) * died in intensive care or in continuing care unit * patient died before january 1st, 2020. * patients deceased following a decision to limit or stop therapeutics exclusion criteria: * patients who died of brain death or unexpected cardiac arrest at death of unsuccessful cardiopulmonary resuscitation * patient who expressed during his lifetime his opposition to the use of his data for scientific research

Keywords: limit or stop treatment in intensive care continuous deep sedation (cds) continuous deep sedation until death (cdsud)
study comparing ultrasound-guided ficnb block to systemic analgesia in treatment of pediatric femur fracture

Conditions: Femur Fracture

Summary: the goal of this prospective observational study is to compare pain control strategies in children with femur fractures. researchers will compare ultrasound-guided fascia iliaca compartment nerve block to iv pain control alone. the main questions it aims to answer are: * are ultrasound-guided fascia iliaca compartment nerve blocks as effective as iv pain control in controlling pain? * do patients who receive an ultrasound-guided fascia iliaca compartment nerve block require less opioid pain medication than those that don't? participants will be asked to provide pain scores during their emergency department stay. participants parents will be asked to complete a brief survey at the time their child is leaving the emergency department.


Eligibility criteria:
inclusion criteria: * acute femur fracture (less than 24 hours from initial injury) * glasgow coma scale of 14 or greater at time of enrollment exclusion criteria: * allergy or hypersensitivity to local anesthetic agents * pregnant * prisoner * neurovascular injury to the affected limb * bilateral femur fractures * confirmed, or significant clinical suspicion for, injury to their head, neck, chest, abdomen, back or pelvis * imaging suggestive of a head, neck, chest, abdomen, back or pelvic injury * laboratory results suggestive of a head, neck, chest, abdomen, back or pelvic injury * a fracture not limited to the extremities (i.e. vertebral compression fracture) * a significantly displaced extremity fractures (aside from the primary femur fracture) * an open fracture (aside from the primary femur fracture) * an additional fracture to the limb of the primary femur fracture (i.e. tibia fracture in the same leg as the primary femur fracture).
haic plus targeted therapy and/or pd-1 inhibitors for unresectable intrahepatic cholangiocarcinoma

Conditions: Intrahepatic Cholangiocarcinoma

Summary: intrahepatic cholangiocarcinoma (icc) is associated with poor prognosis. this study aims to explore the efficacy and safety folfox-haic in combination with targeted therapy and/or pd-1 inhibitors for patients with initially unresectable icc, as well as its role in conversion therapy. data were retrospectively reviewed for patients with locally advanced unresectable icc treated with folfox-haic combined with targeted therapy and/or pd-1 inhibitors. the treatment efficacy and safety were evaluated.


Eligibility criteria:
inclusion criteria: 1. patients were initially diagnosed without any previous oncological treatment. 2. the tumor was assessed as unresectable by two hepatobiliary surgeons (bl and yy, with more than 15 years of experience). any of the following conditions: (1) residual liver volume less than 30-40%; (2) not possible for r0 radical resection; (3) tumor invades the portal vein, hepatic artery and bile duct, and the normal residual liver cannot be guaranteed blood supply and bile drainage; the tumor involves the hepatic veins and cannot preserve at least one vein. 3. at least one assessable intrahepatic lesion. 4. classified as child-pugh grade a. 5. ecog ps score 0-1. 6. baseline blood tests meet the following criteria: leukocytes ≥3.0×10\^9/l; neutrophils ≥1.5×10\^9/l; platelets ≥75×10\^9/l; hemoglobin ≥ 80g/l; serum alt or ast ≤ 3 times of upper limit of normal (uln); serum creatinine ≤1.5 x uln; inr ≤ 1.5, or prothrombin time ≤ uln + 4 seconds; albumin ≥ 30 g/l; total bilirubin ≤ 3 x uln. exclusion criteria: 1. severe underlying cardiac, pulmonary, or renal diseases. 2. a second primary malignancy. 3. prior history of organ transplantation.

Keywords: hepatic arterial infusion chemotherapy targeted therapy pd-1 inhibitors
efficacy and safety assessment of zolpidem (stilnox cr) in patients with chronic insomnia

Conditions: Sleep Disorders

Summary: primary objective: to evaluate the efficacy and safety of the use of stilnox cr in mexican patients with chronic insomnia at the prescription conditions of daily practice secondary objective: to evaluate the satisfaction of the patient with chronic insomnia with stilnox cr over an as needed basis.


Eligibility criteria:
inclusion criteria: - primary insomnia diagnosis (difficulty for initiating sleep, or maintaining sleep to wake up to early in the morning, or to present a restless sleep) which causes clinically significant disturbances in the areas of social, work functioning or other important areas exclusion criteria: * serious, severe and/or acute respiratory impairment * severe liver impairment * hypersensitivity to the formulation components or to some of its active metabolites * pregnant or breast-feeding women patients with important associated disorders in snc and specially psychotic disorders * patients with the probability of using alcoholic beverages concomitantly (as a precaution measure) * chronic use of benzodiazepines moreover, in order to follow the international regulations in terms of the use and handling of hypnotic compounds, and to guarantee the appropriate study performance, no patients with one or more of the following characteristics should be included: * patients who cannot comply to follow-up * patients who have any drug abuse problem * individuals who work changing night shifts or with pathological snoring * presence (or suspicion) of sleep apnea, periodical legs movements or restless legs syndrome the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
bio-banking of specimens for advanced lung disease and lung transplant research

Conditions: Respiratory Failure; Interstitial Lung Disease; Lung Diseases

Summary: a major goal of this protocol is to support biomarker studies in advanced lung diseases, lung transplantation care, and to improve our understanding of the effects of viral and other infectious exposures to outcomes in our lung transplant and ald patient populations.

the identification of biomarkers in a patient's blood or tissue that are specific for particular medical conditions (such as interstitial lung disease, chronic obstructive lung disease (copd), and post-lung transplant rejection) is important for the prevention and early detection of the disease, as well as to advance our understanding of targeted therapies. availability of biomarkers for diagnosis and for the prediction of patient prognosis and therapy promises personalized medicine. patients may be selected based on the presence of particular gene mutations or circulating protein levels to receive personalized treatment. furthermore, knowledge regarding genetic risk and susceptibility to infectious diseases as well as structural lung disease is rapidly growing-as whole genome sequencing and genome-wide association studies have become easier to do, genetic risk has emerged as increasingly important in understanding why and how some patients develop chronic lung disease. this is true for the spectrum of lung diseases treated in the ald program, from those with airways diseases such as copd to diffuse parenchymal lung diseases such as idiopathic pulmonary fibrosis (ipf). the availability of human biological specimens for research purposes is crucial for the advancement of medical knowledge of understanding, diagnosing, and treating chronic lung diseases and optimizing post-lung transplant care.

Eligibility criteria:
inclusion criteria: 1. all individuals aged 18 years and older 2. persons who have undergone lung transplantation at baylor university medical center in the previous 10 years 3. individual is able to understand and sign the informed consent form exclusion criteria: 1. significant documented anemia (hemoglobin \<8 g/dl) 2. blood transfusions within past 3 weeks 3. active cancer (non-skin cancers) 4. enrollment against doctor recommendation 5. patient not able to provide informed consent
i3lte4: intensive insulin therapy and production of lte4 in patients with diabetes

Conditions: Diabetes Mellitus; Leucotrienes

Summary: the primary objective of the study is to assess the effect of a 3-month intensive insulin therapy on urinary leukotriene e4 (lte4) excretion in patients with diabetes.

our group has recently reported the results of a preliminary cross-sectional study, which demonstrated that the urinary lte4 excretion is increased in patients with type 1 diabetes. with regard to recent human genetic studies showing that polymorphisms in the 5-lipoxygenase (5-lo) promoter and flap haplotypes is linked to cardiovascular disease susceptibility our data suggested the potential interest of lte4 as a non-invasive biomarker of cardiovascular risk. in diabetes mellitus, further studies are required to evaluate the 5-lo pathway after improvement of glucose control and concomitantly with established inflammatory cardiovascular biomarkers. the secondary objectives are: before and after 3-month intensive insulin therapy- relationship between a marker of platelet activation (urinary 11-dehydro-thromboxan b2 :11-dehydrotxb2) and urinary lte4- relationship between inflammatory plasma markers of cardiovascular risk (hs-crp and fibrinogen) and urinary lte4- relationship between a plasma marker of endothelial dysfunction (sicam-1) and urinary lte4- changes in lte4 according to patient subgroups (patients with type 1 and type 2 diabetes mellitus)

Eligibility criteria:
inclusion criteria: * diabetes mellitus (type 1 or type 2) * \> 18 year-old * subject has given free, informed written consent * subject entitled to health insurance cover * medical follow-up at the department of diabetology, grenoble university hospital * inappropriate glucose control (hba1c \> 8.5%) requiring an initiation, or revision, of insulin therapy exclusion criteria: * legal incapacity or limited legal competence * pregnant women * heart failure * impaired renal function,defined by a creatinin clearance \< 60 ml/mn according to cockroft formula * asthma * respiratory failure * iv, im, sc or oral treatment with cortico-steroids for the last 2 months prior to baseline * current smoking \> cigarettes / day * any infectious disease for the last 2 months prior to baseline * baseline crp \> 20 mg/l
rosuvastatin impact on ventricular remodelling lipids and cytokines

Conditions: Heart Failure, Congestive

Summary: the purpose of this study is to assess the effect of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo on cardiac remodelling, estimated by change in left ventricular ejection fraction on radionuclide ventriculography, at 26 weeks post randomisation from baseline.


Eligibility criteria:
inclusion criteria: * signed informed consent, males or females aged 18 or older, lvef ≤ 40% assessed by rnvg or contrast ventriculogram or ≤ 35% assessed by tte within the previous 6 months, lvef \< 45% as assessed by rnvg during visit 1, nyha class ii, iii or iv symptoms primarily related to heart failure, ischaemic and non-ischaemic patients and on stable heart failure therapy as defined by physician's best practice. exclusion criteria: * key exclusion criteria include acute myocarditis within the last 12 months, diabetes mellitus not controlled by diet, oral therapy or insulin therapy, homozygous familial hypercholesterolaemia, receiving biventricular pacing or expected to receive biventricular pacing in the next 6 months, subjects who normally would be considered for statin therapy in the next 6 months, sever hypertension, history of definite myocardial infarction, cerebrovascular accident, percutaneous transluminal coronary angioplasty or coronary bypass graft within 3 months prior to enrolment in the study, body mass index \< 15, plus others.

Keywords: ischaemic or non-ischaemic systolic congestive heart failure
work in green spaces and musculoskeletal disorders

Conditions: Musculoskeletal Disorders

Summary: musculoskeletal disorders (msds) of the limbs and spine are painful conditions of the periarticular soft tissues (muscles, tendons, vessels, etc.) and peripheral nerves secondary to overuse of occupational origin. they can manifest as pain (the most common symptom), discomfort, stiffness, loss of precision in movements or loss of strength. the lumbar spine and upper limbs are the parts of the body most frequently affected by msds. msds have a multifactorial origin that can be separated into 2 categories: factors linked to the individual (age, sex, medical history) and factors linked to the work environment (biomechanical constraints, work organization, psychosocial risks). msds are the leading cause of compensated occupational illnesses in france (86% of occupational illnesses in 2021, according to the health insurance annual report), particularly in the agricultural sector to which the majority of professions in green spaces belong. . if, in the grand est of france, the prevalence of employees exposed to physical risks decreased in the majority of sectors of activity between 1994 and 2017, we note at the same time a slight increase in the prevalence in the agricultural sector over this period. same period (6% in 2017 compared to 3.7% in 1994, sumer 2017 survey). concerning the current context in france, the green spaces sector has undergone changes in recent years following the national implementation of the ecophyto plan in 2008 (updated in 2015 then in 2018). this plan, the latest version of which is called ecophyto 2+, aims to reduce the use of plant protection products by 50% by 2025. at the same time, the use of plant protection products for the maintenance of green spaces, forests, roads and walks have been prohibited by the labbé law since january 1, 2017. in this context, and given the absence of recent data from the literature on this subject in france, the investigator wishes to carry out an inventory recent physical and organizational constraints, as well as the prevalence of msds, in the green space sector (targeting more particularly in its study the green spaces of the territorial civil service of the grand est)


Eligibility criteria:
inclusion criteria: * major subject from 18 to 62 years old * subject working in the service of green spaces in the territorial civil service in a city in the grand est, active when the study was carried out * subject agreeing to participate in the study * subject with sufficient command of the french language to understand the self-questionnaire exclusion criteria: * subject not wishing to participate in the study * subject on sick leave * subject under 18 years old or over 62 years old * subject under guardianship or curatorship * subject under judicial protection

Keywords: musculoskeletal disorders osteoarticular
a study of zg005 in patients with advanced solid tumors

Conditions: Solid Tumors

Summary: this is a multi-center, open-label, phase 1/2 study of zg005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of mtd/recommended dose.


Eligibility criteria:
inclusion criteria: * fully understand the study and voluntarily sign the informed consent form. * male or female 18-70 years of age; * eastern cooperative oncology group (ecog) performance status of 0-2; * life expectancy ≥ 3 months; * histologically or cytologically confirmed diagnosis of advanced solid tumors. exclusion criteria: * medical history, computed tomography (ct) or magnetic resonance imaging (mri) results indicate that existence of the central nervous system(cns) metastases; * any other malignancy within 5 years.
professional development in emergency medical services

Conditions: Clinical Decision Support; Clinical Practice Guidelines; Emergency Medical Services

Summary: the prodems-trial focuses on nurses and ambulance drivers working in prehospital care, taking care on the one hand of patients suffering from time-sensitive critical conditions like stemi, acute stroke or severe traumatic brain injury, and on the other hand of patients whose lives are not in immediate danger but suffer from acute exacerbation of chronic conditions or suffer from acute pain. in the current study the investigators will use a multistage approach to test the hypothesis whether the use of a cdss in prehospital emergency care will: 1. improve protocol adherence, 2. reduce emergency department length of stay, 3. improves diagnostic accuracy; without impeding the workflow of the prehospital team or impairing patient safety.


Eligibility criteria:
inclusion criteria: * patients who receive treatment from the paramedic intervention team (pit) in the prehospital emergency medical services (ems) area of the university hospitals, leuven. exclusion criteria: * patient-related interventions not dispatched by the emergency medical dispatch center (emd) * patient related interventions during transport between two healthcare facilities or in mass casualty situations.

Keywords: clinical decision support clinical practice guidelines emergency medical services