Kornimate/medical-research-clean huggingface dataset:
protocol for a multicentre survey of patients with treatment resistant hypertension

Conditions: Treatment Resistant Hypertension

Summary: project aims to determine the number of individuals with treatment resistant hypertension and to define the characteristics of these patients and estimate disease frequency. the study will be a retrospective review of medical record data based upon de-identified information and will require no patient contact.


Eligibility criteria:
inclusion criteria: * \> = 18 years of age * no known secondary cause of hypertension * history of uncontrolled hypertension while using 3 or more anti-hypertensive agents * controlled blood pressure using 4 or more different anti-hypertensive agents exclusion criteria: n/a
regional anesthesia in refractory trigeminal neuralgia: 21 cases reported to the limoges university hospital

Conditions: Trigeminal Neuralgia

Summary: trigeminal neuralgia is defined according to the third edition of the international classification of headache disorders (ichd-3) criteria. chronic pain can have a major impact on the quality of life. first-line treatments are anti-epileptics, and surgical treatments are also possible according to several approaches. sometimes the pain is resistant to these therapies. in this indication, sensory blocks may have a therapeutic impact but their place is not clear. in france, there are formalized expert recommendations on "loco regional analgesia and chronic pain", from 2013. several adjuvants to local anesthetics have been studied for acute and chronic pain. clonidine and dexamethasone are of greatest interest in increasing block duration and reducing opioid consumption. the investigators report the case of 21 patients, treated by a trigeminal block from 2014 to 2018, suffering from a resistant trigeminal neuralgia. after a first consultation, the diagnosis is confirmed, an information is done and an appropriate support is established. the sensory block is performed as an outpatient care. it consists in a peri-neural injection of a mixture of levobupivacaine 5%, cortivazol 3.75mg / 1.5ml (or betamethasone 7mg / 1ml) and clonidine (1μg / kg). standard precautions are respected and patients are monitored in the recovery room after the procedure. the efficacity is evaluated before the exit and a follow-up is done within 15 days. the level of satisfaction expressed by the patients seems to be globally high. the investigators wish to evaluate statistically the impact of the trigeminal blocks, in terms of improvement of the quality of life. this retrospective study, by its procedure, does not change the management of patients.


Eligibility criteria:
inclusion criteria: * major patients with trigeminal neuralgia resistant to usual treatments, according to the ichd-3β criteria * treating by one or more trigeminal nerve blocks * at the peri operative pain management center of limoges university hospital * between 2014 and 2018 exclusion criteria: * not consent * another type of facial block during the previous year. * unavailable medical data * deceased patient

Keywords: chronic pain trigeminal neuralgia regional anesthesia trigeminal nerve block
special drug use investigation (retrospective) for arixtra® (fondaparinux) venous thromboembolism treatment (over 100kg)

Conditions: Ataxia

Summary: the purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness of fondaparinux injection in patients with venous thromboembolism (vte) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day. ("arixtra" is a trademark of the glaxosmithkline group of companies.)


Eligibility criteria:
inclusion criteria: * patients with acute pulmonary thromboembolism or acute deep venous thrombosis * fondaparinux injection must be prescribed for the first time exclusion criteria: * not applicable
tracers for endometrial cancer sentinel node labeling

Conditions: Endometrial Cancer; Sentinel Lymph Node

Summary: sentinel lymph node (sln) biopsy is currently used in the management of vulvar and breast cancers as well as in malignant melanoma, and is being intensively studied in patients with cervical and endometrial cancers. the role of lymphadenectomy in the surgical management of early-stage endometrial cancer is still controversial. the main reason to perform a sln biopsy is to detect the lymph node that will be the first involved with metastatic disease in the nodal basin. the sln biopsy is performed after the sln is located with the use of different tracers in a concept called sln mapping. moreover, sln evaluation has been reported to improve the accuracy of lymph node staging due to sln pathologic ultrastaging, which includes multiple serial sectioning and immunohistochemical assessment. the aim of this project is to conduct a multicentre, prospective, observational trial to compare two different sln labelling methods (radioactive tracer with/without blue dye vs. indocyanine green-icg) in the same patient and to evaluate the unilateral detection rate, sensitivity, number of detected sln, anatomical localisation of detected sln and bilateral detection rate of sln. the main aim of the trial is the comparison of sln mapping between two sln labelling methods in the same patient. the trial will answer a question whether a combination of labelling methods in the same patient increase importantly the sensitivity of sln biopsy. the trial has a high potential to reach the calculated number of cases and thus bring in evidence/data that will be essential for future management of sln biopsies in endometrial cancer.


Eligibility criteria:
inclusion criteria: * histologically proven endometrial cancer (any tumour type). * apparent early-stage endometrial cancer with intermediate or high risk prognostic factors (deep myometrial invasion or g2/g3 disease or non- endometrioid histological type), no evidence of bulky or suspicious pelvic/para-aortic lymph nodes or distant metastases on preoperative conventional imaging studies; minimum requirement for clinical staging includes expert us or pelvic mri for local staging and abdominal us or abdominal ct scan or pet ct for distant staging. * performance status ecog: 0-1. * age ≥18, ≤85. * history of second primary cancer only if more than 5 years with no evidence of disease. * approved and signed informed consent form to participate in the study. exclusion criteria: * pregnancy * desire for fertility sparing * history of pelvic or abdominal radiotherapy
primary prevention with statin and incidence of recurrent mi and cardiogenic shock in post-acs patients

Conditions: Acute Coronary Syndrome; Recurrent Myocardial Infarction; Cardiogenic Shock

Summary: this study aims to evaluate the effect of statin for primary prevention, towards lowering the incidence of recurrent myocardial infarction, cardiogenic shock and mortality in acs patients.

adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under icd-10 coding of i24.9 were included in this study. the inclusion criteria are patients with primary diagnosis of i24.9 and with a complete record of prior medical and treatment history, electrocardiographic findings, cardiac marker results and outcomes. participants were grouped into 2 groups - statin and non-statin based on prior history of statin use prior to acs. diagnosis of acs was made based on clinical, electrocardiographic and cardiac marker findings found in the medical record. data such as age, sex, ethnic, education, prior medical and treatment history, electrocardiographic and cardiac enzyme results as well as outcomes were collected from the patients' medical records. outcomes of interest were defined as either recurrent myocardial infarction, cardiogenic shock, mortality or combinations of them as diagnosed in the medical records. grace and timi scores are calculated to predict in hospital and future mortality rates.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute coronary syndrome * presence of detail on statin prescription history exclusion criteria: * unavailability of electrocardiographic findings, cardiac marker results, grace and timi score parameters * incomplete records of prior medical and treatment history

Keywords: acute coronary syndrome statin mortality grace score timi score
usability validation of patient monitoring device for pressure injury prevention and fall detection

Conditions: Pressure Ulcer; Pressure Injury; Falls Injury

Summary: this study describes a procedure to collect a subject's position, movement, physiological data and usability information using masimo's investigational device.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. icu patient 3. primarily bedbound subjects 4. able to be monitored for a minimum of approximately 8 hours exclusion criteria: 1. pregnancy 2. prisoner status 3. pressure injury stage 2, 3, or ungroupable 4. has a pacemaker or internal defibrillator 5. has a history of complications with a similar study 6. has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
phase ii study of different doses of radiotherapy combined with sintilimab in the treatment of locally advanced esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this study is aimed to evaluate the efficacy and safety of different doses of radiotherapy combined with sintilimab in locally advanced esophageal squamous cell carcinoma.

this study was designed as a two cohorts, phase ii trial. subjects will receive different doses of radiotherapy combined with sintilimab. the primary endpoint is progression-free survival.

Eligibility criteria:
inclusion criteria: * ≥18 years old * histopathological examination of the primary biopsy confirmed the diagnosis of locally advanced esophageal squamous cell carcinoma * at least one measurable lesion * eastern cooperative oncology group (ecog) performance status of 0 to 1 * with adequate organs function exclusion criteria: * patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer * patients who have a higher risk of bleeding or perforation due to the tumor\&#39;s obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula * patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional chinese medicine therapy
school-based telemedicine enhanced asthma management

Conditions: Pediatric Asthma

Summary: this project aims to improve guideline-based asthma care using enhanced communication and screening tools, telemedicine and directly observed therapy of preventive medications in city schools. web-based screening will be used to identify children with persistent or poorly controlled asthma and to send reports to the child's primary care doctor. children in the sb-team group will receive a telemedicine asthma assessment in school and be prescribed a daily preventive asthma medication to be taken through school-based directly observed therapy. the overall aim of this study is to evaluate the use of the sb-team intervention for improving guideline based care, enhancing adherence to effective preventive medications and at reducing morbidity among young urban children with asthma.


Eligibility criteria:
inclusion criteria: 1. physician-diagnosed asthma (based on parent report) 2. persistent asthma or poor asthma control (based on nhlbi guidelines). any 1 of the following: * in past month, \>2 days per week with asthma symptoms * \>2 days per week with rescue medication use * \>2 days per month with nighttime symptoms * \>=2 asthma episodes during the past year that required systemic corticosteroids. 3. age \>=3 and =\<10 years 4. attending school in rochester city school district preschools or elementary schools exclusion criteria: 1. inability to speak and understand english or spanish 2. no access to a phone for follow-up surveys 3. family planning to leave the district within fewer than 6 months. 4. the child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. 5. children in foster care or other situations in which consent cannot be obtained from a guardian.
physical capacity and activity in children with congenital heart disease

Conditions: Heart Defects, Congenital; Tetralogy of Fallot

Summary: congenital malformations correspond to defects in organ morphogenesis identifiable at birth or intrauterine life, affecting 2-3% of births. inside of these malformations, congenital heart disease corresponds, in particular, to structural defects of the heart or major blood vessels thereof may or may not be associated with other types of syndromes.the resolution is usually surgical. also, these patients present a decrease in physical fitness, psychological imbalance, lower quality of life and risk significant morbidity and mortality from respiratory infections among other problems. this can have severe consequences for health in the medium and long term. the habits acquired during childhood and adolescence are determinant for the adult life, being relevant levels of activity and physical condition, especially in children with pathologies. in this way, it is vital to know from childhood parameters that indicate the baseline state of these patients according to the levels of physical activity, exercise capacity, nutritional status and quality of life. these will be key indicators to take into account in the future, to adapt rehabilitation plans that will reduce the effects of their condition. the objective of this protocol is to characterize the levels of activity, and physical capacity of children with congenital heart disease regularly treated at the cardiovascular center of dr. luis hospital calvo mackenna, compared to healthy children matched by age and sex.


Eligibility criteria:
inclusion criteria: * children with tetralogy of fallot corrected * age from 6 to 15 years * assistants to periodic control at hlcm cardiovascular center exclusion criteria: * morbid obesity * musculoskeletal disorders that impede physical activity * neurological comorbidity * respiratory comorbidity in the last 30 days. * pacemaker users

Keywords: physical activity physical capacity children
preoperative ionized magnesium assessment

Conditions: Magnesium Deficiency

Summary: the reported incidence of hypomagnesemia is approximately 2% in the general population. hypomagnesemia is a common problem, occurring in nearly 10%of general hospitalized patients and 17% of hospitalized cancer patients. a higher incidence, up to 60% to 65%, has been found among intensive care unit patients. hypomagnesemia can potentially cause fatal complications including ventricular arrhythmia, coronary artery spasm, and sudden death. it also associates with increased mortality and prolonged hospitalization. magnesium exists in three different forms in the body. in serum, 5-14% of the magnesium is reported to be complexed with anions such as phosphate, bicarbonate, and citrate, 19-33% is reported to be protein-bound (mainly to albumin), and 55-67% is found in the free ionized fraction. because the amount of bound or complexed mg can vary significantly, especially in illness, the ionized magnesium can vary in an unpredictable way. conventional laboratory testing typically only measures total serum magnesium, which is often not reflective of ionized magnesium. unlike ionized calcium, which is commonly measured and is also readily calculated from the total calcium and albumin levels, ionized magnesium is neither commonly measured nor easily calculated. one study reported that the level of ionized magnesium cannot be predicted by analysis of total magnesium and that the levels of ionized magnesium vary upon different pathophysiological conditions and between individuals. furthermore, measurement of ionized magnesium in serum might be of great impact in patients for whom magnesium status is required, and the correlation of ionized magnesium and total magnesium is weak in patients for whom magnesium status is required as a whole, and this is the reason why the ionized magnesium should be measured directly. to date, most of the clinical studies were evaluate the effect of hypomagnesemia on the outcome after surgery using the levels of total serum magnesium. however, the portion of extracellular magnesium that is physiologically active is in the various process is ionized magnesium. so, it is important to evaluate the level of ionized magnesium in surgical patients to predict the outcomes after surgery. unfortunately, clinical trial regarding the effect of the concentrations of ionized magnesium on the surgical patients is limited.


Eligibility criteria:
inclusion criteria: * patients undergoing surgery * aged ≥ 19 * fasted ≥ 8 hours exclusion criteria: * chronic kidney disease * aged \< 19 * fasted \< 8 hours * patients who were taking magnesium
study of gut microbiota in primary immune deficiency, possibly associated with inflammatory bowel disease

Conditions: Primary Immune Deficiencies

Summary: some primary immune deficiencies can be associated with an inflammatory bowel disease, mimicking crohn disease : the chronic granulomatous disease (cgd), the xiap deficiency, and the ttc7a deficiency. this inflammatory bowel disease is frequent but inconstant, raising questions about other factors contributing to the disease. the aim of our study is to analyze, describe and compare the gut microbiota of patients with those primary immune deficiency, with or without intestinal disease. the investigators can expect, in the long term, to compare on a same patient, the gut microbiota evolution, and to assess the role of gut microbiota modifications on the onset of an inflammatory bowel disease.

the investigators will include patients (adults or children), with primary immune deficiency (cgd, xiap or ttc7a deficiencies), and they will collect feces samples from them. in parallel, as control groups, patients with no inflammatory bowel disease and no primary immune deficiency will be included, and also patients suffering from crohn's disease without known primary immune deficiency. the laboratory collaborators will then realize analyzes on the microbiota collected for all patients. the study team will then analyze the microbiota composition of the different types of patients, and try to identify some factors, associated with the appearance of an inflammatory disease on these patients.

Eligibility criteria:
inclusion criteria (patients with one of the 3 specific pid mentioned above): * presenting a primary immune deficiency (cgd, xiap ou ttc7a deficiency) with or without inflammatory digestive disease inclusion criteria (control patients without one of the 3 specific pid mentioned above): * no antibiotic treatment in the month preceding the inclusion exclusion criteria (all patients): * patients having a received a gene therapy or a hematopoietic stem cell transplantation
exposure study comparing 3 routes of methotrexate (mtx) administration

Conditions: Rheumatoid Arthritis

Summary: pharmacokinetics (pk) study

to compare the pharmacokinetic (pk) profiles of methotrexate (mtx) following a subcutaneous (sc) injection of mtx using the vibex device to that obtained after an sc injection of mtx without using the device and to that obtained after an intramuscular (im) injection of mtx in adult subjects with rheumatoid arthritis (ra).

Eligibility criteria:
inclusion criteria: * male or female \>18 years of age with diagnosed rheumatoid arthritis(ra). exclusion criteria: * chronic or acute renal disease * any other clinically significant disease or disorder which, in the opinion of the investigator, might put the subject at risk

Keywords: methotrexate injection, subcutaneous, autoinjector
pharmacokinetic study comparing tiotropium easyhaler® and spiriva® handihaler®

Conditions: Healthy Volunteers

Summary: absorption of inhaled tiotropium is compared between five tiotropium easyhaler product variants and spiriva capsules inhaled via handihaler without charcoal. absorption of tiotropium is compared between one easyhaler product variant administered with and without charcoal.


Eligibility criteria:
main inclusion criteria: 1. healthy males and females 2. 18-60 years of age 3. body mass index 19-30 kg/m2 4. weight at least 50 kg 5. written informed consent obtained main exclusion criteria: 1. evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease 2. any condition requiring regular concomitant treatment 3. any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject 4. known hypersensitivity to tiotropium bromide, atropine or its derivatives or lactose 5. pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness 6. blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.