Kornimate/medical-research-clean huggingface dataset:
prevalence, severity, risk factors, and prognostic value of hyponatremia in patients with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: hyponatremia (hn) is the most common electrolytic disorder in the traumatic brain injury (tbi) population, found in 17 to 51% of patients according to the series. two etiologies predominate in the literature, the syndrome of inappropriate anti diuretic hormone (siadh) and the cerebral salt waste syndrome (csw), but none has been precisely described in terms of epidemiology, risk factors or severity. moreover, siadh and csh were often confused in previous works. the main goal of our study is to assess retrospectively prevalence, severity, time to onset, length, risk factors of hn in a large population of tbi patients, as well as treatment modalities and prognosis. a specific distinction was performed between siadh or csw.

this is a retrospective descriptive study. the included patients will be those admitted in the trauma intensive care unit of lapeyronie university hospital (montpellier, france) with a tbi (head ais ≥1) during a period of 4 years, 01/01/2014 to 31/12/2017. using our databank the investigators estimate 650 to 700 patients who met inclusion criteria during this period and will be analyzed. inclusions will be confirmed after the opening of medical records. definition of siadh is defined as the occurrence of a hyponatremia (≤135 mmol/l) associated with inappropriate urine concentration (urinary/plasmatic osmolarity ≥1) and a low daily urine volume (\<1500 ml/24h). definition of csw is defined as the occurrence of a hyponatremia (≤135 mmol/l) associated with a massive natriuresis (\>140 mmol/l) and a daily urine volume \> 1500 ml/24h. data collection will concern the medical records: medical history, traumatism severity, cerebral injuries on computed tomography, severe complications, specific treatments, and biological course from icu admission to discharge. the main endpoint will be the prevalence of hyponatremia (≤135 mmol/l) in the first 10 days after the traumatic brain injury. the secondary endpoints will be the prevalence specific prevalence of csw and siadh, risk factors of these nosological entities, their severity, their timing to onset and their morbimorality.

Eligibility criteria:
inclusion criteria: * âge ≥ 18 years * presence of traumatic brain injury at the icu admission exclusion criteria: * discharged from icu or death \< 48 hours from the admission * lack of data

Keywords: hyponatremia syndrome of inappropriate anti diuretic hormone (siadh) cerebral salt waste syndrome (csw)
shearwave™ elastography to assess liver fibrosis in chinese patients with hepatitis b

Conditions: Liver Fibrosis

Summary: this study will evaluate how liver stiffness measurements made with shearwave™ elastography (swe) correspond with a biopsy result (currently the gold standard). the population that will be evaluated are chinese patients infected with the hepatitis b virus.

hepatitis b is becoming increasingly common. the liver becomes stiffer and this is called fibrosis. a non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. currently, liver biopsy is used to do this, but there are many disadvantages with this technique. shearwave elastography (swe), available on the ultrasound machine aixplorer®, is a non-invasive method to evaluate liver fibrosis. this study will evaluate how liver stiffness measurements made with swe correspond with a biopsy result (currently the gold standard). the sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with aixplorer to evaluate the different stages of fibrosis will be analyzed. liver stiffness measurement made by the aixplorer will also be compared to blood markers

Eligibility criteria:
inclusion criteria: * patients undergoing a liver ultrasound exam due to confirmed hepatitis b infection , * patients having reached the age of majority in china, * patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the swe measurement date, and having the recommended quality criterion: * minimal length of biopsy samples of 15 mm, stored in paraffin * minimal number of portal tracts of 6 per biopsy samples * patients of chinese ethnic origin exclusion criteria: * any patient presenting with combined etiologies of chronic liver diseases, including non-hepatitis b viral infection（hepatitis a, c, d, e, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc) * history of antiviral therapy at any time * any patient presenting with a co-infection of hiv * any patient presenting with combined liver malignant tumor * previous liver transplantation * pregnant women * any patient with combined hepatic congestive condition such as budd chiari syndrome, congestive heart failure, chronic constrictive pericarditis... * any patient combined with intrahepatic cholestasis

Keywords: liver fibrosis elastography shearwave elastography ultrasound
development and test of a headset for bci until obtaining an efficient and comfortable system that can be used in daily practice by als people

Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Spinal Cord Diseases; Alternative Communication Devices; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases

Summary: "brain-computer interfaces (bcis) are computer-based systems that acquire brain signals, analyze them, and translate them into commands that are relayed to an output device to carry out a desired action. bcis represent a very active and promising field of research among devices for people with severe motor disabilities. as the currently available systems correspond to research prototypes, they are not adapted to daily live situations. on the other hand, some systems have recently been commercialized, principally for video games but they are not satisfactory for use as a substitute technology in disability. a bci's prototype for alternative communication using a virtual keyboard, the p300 speller, has been developed by the national institute for research in digital science and technology (athena team - nice university). this prototype includes an eeg-cap with gel based active electrodes. a recent study conducted on 20 patients with als (university hospital, nice) demonstrated the usability of the system and the patient satisfaction concerning the ease of use and utility. to achieve a system that can be used in daily live in severely disabled patients, technical developments are necessary. the investigators have conceptualized and developed an ergonomic, comfortable, headset, including dry electrodes to allow a prolonged use of the system. the purpose of the study conducted all along the development of the headset is to improve the developed system until a successful system is achieved. this study is a monocentric usability study conducted on als people.


Eligibility criteria:
inclusion criteria 1. age ≥ 18 years old 2. for women of childbearing potential, use of contraception for the duration of the study 3. diagnosis of suspected als, possible, probable with enmg, probable, defined according to the criteria of the world federation of neurology (revised el escorial criteria, airlie house conference 1998) 4. understanding of the objective of the study after describing the principle of the p300 speller and the course of the study 5. ability to follow the study procedure and to comply with the schedule of visits when entering the study 6. expression of a p300 wave under the conditions of the study exclusion criteria 1. psychiatric illness or dementia that may interfere with the patient's ability to follow study procedures 2. history of photosensitive epilepsy 3. patient subject to protective measures 4. non-correctable visual disturbances 5. limited ability to concentrate. 6. women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study. 7. persons deprived of their liberty by a judicial or administrative decision
clinical trial of pulmonary cryptococcosis in china

Conditions: Cryptococcosis

Summary: the purpose of the study:1.improve the understanding of the risk factors of pulmonary cryptococcosis;2.improve the awareness of pulmonary cryptococcosis clinical and imaging manifestations;3.grasp pulmonary cryptococcosis patients of clinical and imaging manifestations in different conditions;4.learn about antibacterial activity of antifungal drugs for cryptococcosis in china.

1. patients corresponding to inclusion criteria and obtaining informed consent are included in the research in department of respiration ward in cooperative hospitals. 2. relevant case report forms are created in this study. 3. basic information such as age,weight and height is recorded in selected cases.clinical manifestations,risk factors,laboratory examination,imaging examination,etiological examination and histopathological examination are also recorded in selected cases by case report forms.in addition,antifungal treatment is recorded including name,dose,time of starting treatment and terminate treatment.causes of terminate treatment and curative effect evaluation should be analysed. 4. statistical analysis.

Eligibility criteria:
inclusion criteria: patients possess clinical or imaging manifestations of pulmonary infections,with any of the results(by one of following conditions) by microbiological examination or histopathologic examination 1. cryptococcal capsular polysaccharide antigen of blood or pleural effusion is positive 2. cryptococcus（fungus culture) is discovered by lower respiratory tract specimens 3. cryptococcus（pleural effusions culture) is discovered by pleural effusions collected under sterile condition 4. cryptococcus（pus culture) is discovered by pus smear out of pulmonary infections in disseminated infection patients 5. cryptococcus（blood culture) is discovered by microscopy of specimens of blood smear 6. cryptococcus is discovered by culturing of the pathological tissue specimens in aseptic condition 7. cryptococcal capsular budding yeast with inflammatory reaction is discovered by histopathological examination,cell pathology examination or microscopic examination in aseptic condition exclusion criteria: 1. patients suffer from acquired immune deficiency syndrome 2. patients or their legal guardians request to withdraw the clinical research

Keywords: pulmonary cryptococcosis
effects of epalrestat on peripheral neuropathy and central nervous system in diabetic patients

Conditions: Diabetes

Summary: this study evaluated the efficacy of epalrestat in diabetic peripheral neuropathy and its effects on the central nervous system in diabetic peripheral neuropathy subjects.


Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 65 years (to the date of screening)； 2. a clear history of type 2 diabetes (using the 1999 who diabetes diagnostic criteria) with a course of disease \> 6 months; 3. hba1c \< 7%; 4. two or more of the following five tests are abnormal: abnormal temperature perception; nylon wire for hypoesthesia or disappearance of the foot; abnormal vibration sense; ankle reflex disappeared; two or more nerve conduction velocities were reduced; 5. have not used mecobalamin, epalrestat, lipoic acid or high-dose glucocorticoid in the recent (3 months) period, or have not been involved in other treatment of the same disease within 3 months prior to the study; exclusion criteria: 1. neuropathy caused by other causes, such as cervical and lumbar lesions, cerebral infarction, etc.; 2. with acute metabolic complications of diabetes, such as ketoacidosis, lactic acidosis, diabetes hyperotonic state, etc; 3. severe cardiovascular and cerebrovascular diseases , pulmonary heart disease or pulmonary insufficiency, renal failure, severe dyslipidemia, poorly controlled hypertension, severe hepatitis. 4. those with a history of malignant tumor or wasting diseases such as tuberculosis; 5. contraindications to mri scanning: such as internal (especially oral) metal implants, claustrophobia, etc; 6. poor compliance or serious side effects; 7. pregnant female.
web-mediated risk assessment for endoscopic screening of gastric cancer

Conditions: Gastric Cancer

Summary: gastric cancer is one of the most common malignancies in china. early detection is critical for gastric cancer management. however, the diagnosis rate of patients with early gastric cancer is still low. therefore, the investigator design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve early gastric cancer diagnosis rate.


Eligibility criteria:
inclusion criteria: * 1.age 18-60. 2.signed informed consent exclusion criteria: * 1.severe back ground disease including malignancy. 2.state after gastric surgery. 3.copd, chf, crf and any disease with respiratory disturbances. 4.deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.

Keywords: gastric cancer screening risk assessment
phase ii of lenvatinib plus pd-1 antibody for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with pd-1 antibody in patients with advanced hepatocellular carcinoma (hcc)

lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and pd-1 antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. no study has evaluated the efficacy and safety of lenvatinib plus pd-1 antibody. thus, the investigators carried out this single-arm, prospective, phase ii study to find out it.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * eastern cooperative oncology group performance status of 0 to 2 * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: * platelet count ≥ 75,000/μl * hemoglobin ≥ 8.5 g/dl * total bilirubin ≤ 30mmol/l * serum albumin ≥ 30 g/l * asl and ast ≤ 5 x upper limit of normal * serum creatinine ≤ 1.5 x upper limit of normal * inr ≤ 1.5 or pt/aptt within normal limits * absolute neutrophil count (anc) \>1,500/mm3 * ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma lenvatinib pd-1 antibody
different risk stratification models for prediction of lymph node involvement in endometrial carcinoma

Conditions: Endometrial Cancer

Summary: endometrial cancer is the most common malignant disease of the female genital tract and the seventh most common cause of cancer death in women in western countries. histological type, grade and depth of myometrial invasion are prognostic factors in early stage disease as well as risk factors for lymph node metastasis. systematic lymphadenectomy has recently been questioned for stage i disease based on the results from two randomized trials


Eligibility criteria:
inclusion criteria: * not virgin * not having congenital anomalies * early stage * body mass index less than 35 exclusion criteria: * virgin * advanced stage * sever infection especially in the pelvis * lymphadenopathy for any cause * lymphadenectomy for any cause * bmi more than 35 * synchronous malignancies
resistance training and post workout protein to improve body composition during neoadjuvant chemotherapy for breast cancer

Conditions: Cancer; Breast Cancer

Summary: in this study, the investigators hypothesize that a high dose of post-workout protein nutrition regimen focused on food quality and an observed exercise regimen utilizing high-load resistance training initiated during or after cancer treatment will improve body composition and functional capacity.


Eligibility criteria:
inclusion criteria: 1. age 20-89 years 2. women with a biopsy proven diagnosis of invasive carcinoma of the breast. 3. women must undergo neoadjuvant chemotherapy for breast cancer treatment prior to surgery 4. must be able to read and understand english and consent for themselves. exclusion criteria: 1. inability to get up and down off the ground or squat body weight 2. inability to safely engage in group exercise sessions as deemed by study pi 3. severe arthritic, joint, cardiovascular, musculoskeletal, or any other condition deemed by pi to be unsafe to engage in resistance training 4. lactose intolerance 5. cow's milk or whey protein allergy 6. pregnant women 7. males

Keywords: exercise resistance training
testing self-directed care in florida

Conditions: Mental Disorder

Summary: this study tests a psychosocial intervention called mental health self-directed care by assessing its impact on recovery, mental health status, rehabilitation outcomes, and service costs in the state of florida.

with additional funding from the national institute on disability, independent living, and rehabilitation research (nidilrr), a new cohort of 40 study subjects will be recruited in the state of florida to test mental health self-directed care (sdc). sdc is a self-directed model of service delivery in which participants manage a personal budget from which they purchase goods and services, including specific types of mental health care, social supports, and items that allow them to recover their health and emotional wellness and live independently. investigators are studying the impact of sdc on recovery, mental health status, rehabilitation outcomes, and service costs. working with lutheran services florida, a public managing entity coordinating mental health care management in northeastern and central florida, adults with mental health conditions will be recruited into the study and randomly assigned to receive sdc for one year or continue receiving services as usual. assessments will occur at baseline, 6- and 12-month followup.

Eligibility criteria:
inclusion criteria: * age 18 and older * serious mental illness * receiving services coordinated by behavioral health managing entity exclusion criteria: * cognitive impairment preventing informed consent * enrollment in medicaid/medicare * representative payeeship * court-mandated treatment * recent substance disorder crisis * in residential treatment * history of violent behavior in the past 10 years

Keywords: self-directed care
radiomics for prediction of long term survival and local failure after stereotactic radiotherapy for brain metastases

Conditions: Metastases, Neoplasm

Summary: published prognostic scores have limitations in prediction of long term survival after stereotactic radiotherapy for brain metastases. moreover, no validated tools are available for prediction of local failure. the value of radiomics is evaluated in this perspective.

sensitivity is low for prediction of long term survival of currently available prognostic scores for brain metastases. first the current clinical models will be optimized with a new prognostic model and nomogram. radiomics is a tool to analyze tumor characteristics based on ct and mr images. these tumor characteristics may reflect tumor biology and outcome. therefore it is investigated if radiomics improves prediction of long term survival after stereotactic radiotherapy for brain metastases. moreover, the predictive value of radiomics for local failure is investigated.

Eligibility criteria:
inclusion criteria: * cerebral metastasized patients exclusion criteria: -

Keywords: metastases, neoplasm cerebral
investigation of the pharmacokinetics of nnc172-2021, at two different dose levels, in healthy japanese subjects

Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate the pharmacokinetics (how the trial drug is distributed in the body) of nnc172-2021 administered subcutaneously, at two different dose levels, in healthy japanese subjects.


Eligibility criteria:
inclusion criteria: * healthy male japanese subjects defined as: subjects born in japan, time residing outside of japan does not exceed 5 years, both parents and all 4 grandparents of japanese descent * body weight between 50 and 100 kg, both inclusive * body mass index (bmi) between 18.0 and 30.0 kg/m\^2, both inclusive exclusion criteria: * male subjects who are sexually active and not surgically sterilised who, or whose partner, are unwilling to use two different forms of effective contraception, one of which has to be a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication * planned surgery 30 days prior to trial product administration and/or during the entire trial period * known hepatic dysfunction during the last 12 months prior to screening (visit 1) * positive urine test for drugs of abuse * active hepatitis b and/or hepatitis c infection * positive for human immunodeficiency virus (hiv) * subjects with clinical signs of thromboembolic events, considered to be at high risk of thromboembolic event or subjects with a known first degree family history of thromboembolism * participation in any other trial investigating other products or involving blood sampling within the last 30 days prior to screening * use of non-steroidal anti-inflammatory drugs (nsaids) such as acetylsalicylic acid (asa), but not ibuprofen and cyclooxygenase-2 (cox-2) specific inhibitors within 2 weeks prior to trial product administration (visit 2) * positive alcohol test at screening (visit 1) and/or history of alcohol or drug abuse within the last 12 months prior to screening (visit 1) * smokers; defined as tobacco users smoking more than 5 cigarettes per day or the corresponding amount of tobacco consumption * blood donation within the last 3 months prior to screening and/or during the entire trial period * strenuous exercise (as judged by the trial physician) within the last 4 days prior to screening (visit 1)