Kornimate/medical-research-clean huggingface dataset:
systolic function and weaning-induced pulmonary edema (systowean study)

Conditions: Mechanical Ventilation Complication; Pulmonary Edema

Summary: the purpose of this study is to determine if the left and right ventricular systolic function is involved in the development of weaning failure related to weaning-induced pulmonary edema.

weaning from mechanical ventilation remains a central step in the management of critically-ill patients, since weaning failure and prolonged duration of mechanical ventilation are not only associated with an increase in the length of stay in intensive care but also with greater morbidity and mortality. one of the well-recognized causes of weaning failure is weaning-induced pulmonary edema (wipo), which accounts for almost 60% of the causes of weaning failure and ranging up to 75% in high-risk patients, i.e. patients with medical history of chronic heart disease, chronic respiratory failure and obesity. echocardiography is increasingly used in intensive care and allows non-invasive assessment of diastolic function as well as left ventricular (lv) and right (rv) systolic function, including during a spontaneous breathing test. although lv diastolic dysfunction appears to be a major determinant of wipo, the role of lv and rv systolic dysfunction is less unequivocal and has been poorly studied so far. scarce data showed that patients experiencing wipo tended to exhibit more frequently lv systolic dysfunction, as demonstrated by a lower lv ejection fraction (lvef) and no study but two have investigated the potential role of rv systolic function. moreover, assessing lv systolic function with lvef measurement suffers from several limitations, especially in critically-ill patients. thus, the main goal of this study is to investigate whether lv and rv systolic function is involved in the development of wipo. the second goal of this study is to determine the best echocardiographic parameter to assess lv and rv systolic function during the weaning process.

Eligibility criteria:
inclusion criteria: 1. invasive mechanical ventilation for more than 48 hours 2. patients indicated, according to intensivists, for carrying out a spontaneous breathing trial weaning test, based on the presence of all of the following criteria: 1. spo2\> 90% with fio2 ≤40% and peep ≤5 cmh2o 2. cough effectiveness on tracheal aspirations 3. lack of hemodynamic instability and of disorders of consciousness 3. patients at high risk of weaning-induced pulmonary edema (wipo), defined by one or more of the following criteria: 1. obesity, defined by a body mass index\> 30 kg/m² 2. chronic obstructive pulmonary disease 3. chronic heart disease exclusion criteria: 1. age \<18 years and pregnant women 2. patients with a decision of not to resuscitate 3. poor echogenicity 4. severe mitral valve disease (leakage and/or stenosis, bioprosthesis) 5. patients with pacemaker 6. tracheostomy 7. chronic neuromuscular or neurodegenerative diseases
multicenter study of family nursing to treat heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to determine whether family focused nursing are effective in the treatment of heart failure outpatients with respect to health-related quality of life.

quality of life is impaired among patients with heart failure and their next of kin compared to other patients with chronic diseases. besides, there are still a number of patients who misunderstand or have difficulties remembering the counseling they are provided during the course of illness. international guidelines recommend that the patient's relatives are involved in patient education as well as the treatment. family interventions might contribute to improvement in quality of life, enhanced illness-management and delayed readmission and mortality among patients with heart failure. however, up till today, only two observational studies have investigated the effect of family intervention on outcomes of treatment for heart failure.

Eligibility criteria:
inclusion criteria: * referred to follow-up nursing treatment in nurse-led heart failure clinic * diagnosed chronic heart failure, based on systolic dysfunction (left ventricular ejection fraction (lvef) ≤40%) * new york heart association (nyha) classification ii-iv symptoms * signed informed consent exclusion criteria: * patients not understanding or talking danish * in terminal phase of another serious illness such as i.e. cancer with expected lifetime less than 6 months * patients not giving informed consent

Keywords: heart failure family nursing health-related quality of life heart failure clinic
preliminary experimental study on key technologies for early screening of gastric cancer

Conditions: Gastric Cancer; Healthy

Summary: this project aims to collect peripheral blood samples from newly diagnosed gastric cancer patients and healthy individuals. various techniques such as cfdna sequencing, proteomics, and fragmentomics will be employed to analyze differences in the expression of ctdna mutations, fragmentomics, and protein biomarkers between gastric cancer patients and healthy individuals. a new comprehensive diagnostic model will be established and its diagnostic value (sensitivity, specificity, accuracy, etc.) for gastric cancer will be validated. specifically, the study will involve the following subjects and quantities: 700 participants from zhejiang cancer hospital (350 gastric cancer patients and 350 healthy individuals), 200 participants from sichuan cancer hospital (100 gastric cancer patients and 100 healthy individuals), and 200 participants from the sixth affiliated hospital of sun yat-sen university (100 gastric cancer patients and 100 healthy individuals). peripheral blood samples (a total of 15ml from each participant, collected in 3 tubes) will be collected from all subjects. the collected blood samples will undergo multi-omics sequencing including cfdna methylation sequencing, proteomics, and genomics to establish a multi-omics-based early diagnostic model.


Eligibility criteria:
inclusion criteria: * age between 18 and 100 years. * ecog performance status of 0 or 1. * pathologically confirmed stage i-iii gastric cancer patients. * patients who have not undergone any anti-tumor treatment (including chemotherapy, radiotherapy, targeted therapy, surgery, anesthesia, etc.) before blood collection. * subjects and their family members who can comprehend the research protocol and are willing to participate in the study, providing written informed consent. exclusion criteria: * presence of other hereditary diseases or other tumors. * severe inflammatory reactions caused by acute illnesses within 14 days prior to blood draw or use of steroids. * previous organ transplantation, stem cell transplantation, bone marrow transplantation, or blood transfusion within the last month before enrollment. * pregnant women. * participation in other clinical trials requiring medication intake within the last 60 days (including anesthesia). * severe cardiovascular diseases, uncontrolled infections, or other uncontrollable comorbidities. * subjects or family members unable to comprehend the conditions and objectives of the study.

Keywords: gastric cancer proteomics diagnostic model
mediastinal staging of lung cancer with ebus-tbna and eus-b-fna

Conditions: Lung Cancer

Summary: the purpose of this study is to find a role of eus-b-fna in the mediastinal staging of potentially operable lung cancer. the investigators perform ebus-tbna and eus-b-fna on potentially operable lung cancer patients. the investigators perform ebus(+/- tbna) and eus-b (ultrasonographic examination through the esophagus) on all subjects. eus-b-fna will be performed on inaccessible nodes or difficult nodes to be sampled by ebus-tbna. additional diagnostic values of eus-b-fna as compared to ebus-tbna alone will be estimated.


Eligibility criteria:
inclusion criteria: * histologically confirmed or strongly suspected potentially operable non-small cell lung cancer (nsclc) * potentially operable patients exclusion criteria: after staging work-up for nsclc, including bronchoscopy,ct of the chest and upper abdomen, integrated pet/ct and brain mri (and/or bone scan) * m1 disease * inoperable t4 disease * mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest ct. * confirmed supraclavicular lymph node metastasis * pancoast tumors * medically inoperable patients * contraindications for bronchoscopy

Keywords: staging endobronchial ultrasound endoscopic ultrasound
assessment of teleconsulting in nursing homes to avoid transportations to the emergency units

Conditions: Nursing Homes Residents

Summary: the purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents.


Eligibility criteria:
inclusion criteria: * all residents of selected nursing homes exclusion criteria: * none
clinical study of schizophrenia in both men and women

Conditions: Schizophrenia

Summary: the objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility.


Eligibility criteria:
inclusion criteria: * if female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception. * diagnosis of schizophrenia * patients must be taking clozapine monotherapy or other atypical antipsychotic at least 3 months prior to this study. exclusion criteria: * patients who are currently taking or have taken antidepressant medication in the last month prior. * patients who are or have been suicidal or homicidal in the last 6 months. * patients with a history of autistic disorder or another pervasive developmental disorder * patients whose condition is due to the direct physiological effects of a substance (e.g. a drug of abuse, a medication) or a general medical condition

Keywords: schizophrenia lamotrigine
plasma microrna for prediction of hepatocellular carcinoma

Conditions: Hepatitis C

Summary: 100 patients with diagnosed hcv were evaluated by clinical and ultrasound examination and were categorized as uncomplicated hcv (n=22) and complicated hcv (n=78). all patients were evaluated for hepatosteatosis and liver fibrosis using the computerized hepatorenal index, the hepatic steatosis index, aspartate aminotransferase (ast)/platelet count index (apri) and the fibrosis-4 (fib-4) scores. blood samples were obtained for estimation of serum levels of liver function tests and plasma levels of microrna 21 and 126.


Eligibility criteria:
inclusion criteria: * complicated hepatitis c by hcc * complicated hepatitis c by liver cirrhosis * complicated hepatitis c by steatohepatitis * uncomplicated hepatitis c exclusion criteria: * pre-portal fibrosis secondary to previous bilharzial disease * pre-portal fibrosis secondary to alcoholic fatty liver * the presence of hepatic malignancy other than hcc * decompensated cirrhosis * hepatorenal failure * hepatic manifestations of congestive heart failure.
rosuvastatin (crestor) in friedreich ataxia

Conditions: Friedreich Ataxia

Summary: this study is an exploratory open-label clinical trial of rosuvastatin in patients with friedreich ataxia (frda). this is an outpatient trial with the goal of enrolling 10 evaluable adults with genetically confirmed frda who are between the ages of 18-65. subjects will receive 10mg of oral rosuvastatin daily for three months.

friedreich ataxia (frda) is a progressive neurodegenerative disease of children and adults for which there is presently no therapy. much of the current work in frda is aimed at finding new targets for drug therapies. recent work at the university of pennsylvania has discovered that serum apoa-1 protein levels are lower in people with frda when compared with control levels. apoa-1 is the main protein found in high-density lipoprotein (hdl) cholesterol and individuals with frda frequently have low hdl levels; the current study proposes to assess if administration of hmg-coa reductase inhibitors for 3 months alters apoa-1 protein levels in frda. although the significance of apoa-1 levels among frda patients is currently unknown, this study is proposed as an exploratory study to further examine this protein. if apoa-1 protein levels increase over the course of treatment, future studies may additionally focus on examining this as a potential therapeutic treatment.

Eligibility criteria:
inclusion criteria: * subjects with friedreich ataxia confirmed by genetic testing * adults between the ages of 18 and 65 * stable quinone dose (at least 1000 mg of idebenone or 200 mg coenzyme q10) for 14 days prior to study entry and for the duration of the study * females who are not pregnant or breast feeding, and who do not intend to become pregnant. * subject has voluntarily signed consent form * willingness and ability to comply with all study procedures exclusion criteria: * treatment with statins during the six previous months before study inclusion * currently active or unresolved liver or kidney disease * known history of renal insufficiency or creatine kinase \>2 x uln * use of red rice yeast during the previous six months before inclusion * current use of niacin and/or fibric acid derivatives * current use of cyclosporine * use of any investigational product within 30 days of baseline visit

Keywords: friedreich ataxia
procarbazine hydrochloride capsule (natulan®) clinical trial protocol

Conditions: Advanced Hodgkin's Lymphoma

Summary: 1. to observe and compare the overall response rate (orr) of baseline beacopp and abvd regimens for patients with advanced hodgkin's lymphoma. 2. to evaluate the safety of natulan® in chinese patients with advanced hodgkin's lymphoma

this is a confirmatory open-label, randomized, controlled, multicenter study. recruited subjects are to be randomized to treatment group and controlled group, with ratio of 1:1. treatment group will accept baseline beacopp regimen, while controlled group will accept abvd regimen. the study design consisted of a screening phase of 1 week, a treatment phase of 24 or 32 weeks, and a post treatment follow-up of at least 2 years.

Eligibility criteria:
inclusion criteria: * the subject is of age 18\~65, both male and female; * newly pathologically diagnosed with classical hodgkin's lymphoma (lymphocyte depletion type, lymphocyte rich type, nodular sclerosing type, and mixed cellularity type), who had not accepted previous treatment; * had stage iib, iii or iv disease, as assessed by the ann arbor classification; * ecog≤2, life expectancy ≥3 month; * a negative serum pregnancy test required for sexually active women of childbearing potential; * the subject voluntarily gives written informed consent to participate in the study. exclusion criteria: * hematopoietic function: * leukocyte \<3,500/mm3（3.5×109/l） * neutrophils \<1,500/mm3（1.5×109/l） * platelets \<100,000/mm3（100×109/l） * intolerance to any of the active ingredients and/or excipients in the study medications; * severe central nervous system disorders and mental illness; * severe heart disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease, or myocardial infarction, or severe arrhythmia). echocardiography showed resting left ventricular ejection fraction (lvef) \< 50%); * history of severe lung disease; * ast or alt\>2.5×uln，total bilirubin≥1.5×uln，serum creatinine\>1.5×uln (for subject with liver metastases: ast or alt\>5xuln, total bilirubin ≥ 3xuln); * uncontrolled, systemic, active infection； * positive serology to hiv; * hbsag positive subjects can still be enrolled in the study, but researchers should follow "the consensus on the treatment of lymphoma with hepatitis b infections" to observe closely and/or provide prophylactic anti-hbv therapy (as per investigator's decision); * other previous or concomitant malignancy, except for basal cell carcinoma and/or cervical carcinoma in situ; * the subject is receiving an investigational drug, or has participated in an investigational study within 30 days prior to screening; * the subject is pregnant or lactating; or subjects of childbearing potential (both women and man subjects) do not want to take effective contraceptive measures during study period or within 3 months after study completes; * investigators believe subjects not suitable to participate in the study for other reasons.
the effect of cerebral oxygenation on postoperative recovery in intracranial surgery

Conditions: Intracranial Neoplasm

Summary: the aim of this study was to investigate the effect of cerebral oxygenation on postoperative compilation in intracranial surgery.

patients undergoing intracranial surgery will be divided into two groups; group (group control n = 100) and cerebral oxygenation monitoring group (group oxygen). all hemodynamic parameters such as systolic blood pressure and diastolic blood pressure, oxygen saturation, et co2, spo2;% and bis during anesthesia during anesthesia will be recorded intraoperatively and 10 postoperatively in 5 min intervals. after extubation, modified aldrete score, gks (glasgow coma scale), ramsey sedation scale (rss), nausea-vomiting and pain will be recorded in the recovery room. pain assessment will be done with visual analog scale (vas). patient satisfaction will be recorded. mmst (mini mental state test) and asem (antisaccadic eye movement test) tests will be performed preoperatively and postoperatively at 1st, 2nd and 3rd days.

Eligibility criteria:
inclusion criteria: * intracranial surgery will be performed * age 25-75 * asa in the i-ii-iii risk group exclusion criteria: * under gks 15 * heart failure, * renal insufficiency, * liver failure, * congenital neurological deficits

Keywords: cerebral oxygen monitoring intracranial surgery general anesthesia
a clinical trial to evaluate the pharmacokinetics and safety of fimasartan and amlodipine in healthy male subjects

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety when administrated fimasartan/amlodipine and when co-administrated fimasartan and amlodipine.

this is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of fimasartan/amlodipine and co-administration of fimasartan and amlodipine.

Eligibility criteria:
inclusion criteria: 1. male 19-50 years of age. 2. body mass index (bmi) ≥ 18 and ≤ 27 kg/m2 at screening. 3. medically healthy with no clinically significant medical history. 4. understands the study procedures in the informed consent form (icf), and be willing and able to comply with the protocol. exclusion criteria: 1. history or presence of clinically significant medical or psychiatric condition or disease. 2. positive results at screening for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv). 3. seated blood pressure is less than 100/65 mmhg or greater than 140/90 mmhg at screening. 4. plasma donation within a month prior to the first dose of study drug. 5. participation in another clinical trial within 3 months prior to the first dose of study drug(s).

Keywords: fimasartan
sleep and obesity in teenagers

Conditions: Obesity

Summary: this study aims to investigate 1. whether sleep extension results in improvements of endocrine and metabolic markers of obesity and diabetes in obese teenagers, 2. the relationship between habitual sleep quality and duration and markers of obesity and diabetes in lean and obese teenagers.

inclusion of 13 obese teens. duration : 1 week of screening period + 1 week of intervention: habitual/extended sleep length + 1 week of intervention: extended/habitual sleep length. a wash out period of at least 3 months will be required between the two interventions. inclusion of 13 non obese healthy teen controls for measuring reference sleep duration and physiology level. duration for these group: 1 week of screening period + 1 week of habitual sleep length

Eligibility criteria:
inclusion criteria: * male or female over 15 and under 18 year-old. * teenager with normal weight or stage 2 obesity, according to international standards (who) * post-pubescent teenagers (menstruation for girls and stage 4-5 of tanner scale for boys) * teens with an social security * girl with negative urine pregnancy test exclusion criteria: * active smoker (interview) * refuse consent (parents or teen) * addiction such as coffee, drug...(interview) * medicinal treatment that may influence sleep and measured variables (interview) * obesity diagnosis : less than 1 year (interview) * concomitant diseases : renal or hepatic failure, iron deficit, diabetes, endocrinal pathology, hypertension * anxiety (spielberg\>56), , depression (cdi\>19). * mild or sever insomnia (isi\>15), poor sleep quality (psqi \>10), excessive sleepiness (epworth\>10, sleep) length\>9 hour), extreme circadian typology (horne et ostberg from 70 to 86 or 16 to 30) * blood sample taken within the last two months before inclusion * mild or severe sleep apnoea or excessive leg movements according to eeg analysis

Keywords: obesity glucose metabolism disorders appetite regulation sleep adolescent randomized controlled trials
anesthesia and cancer recurrence im malignant melanoma

Conditions: Malignant Melanoma

Summary: studies in animals and retrospective studies in humans show that regional anesthesia reduces metastatic cancer dissemination. the investigators hypothesize that in patients suffering from malignant melanoma who have to undergo radical inguinal lymph node dissection immune function will be less compromised and long term survival will be superior when spinal anesthesia is compared to general anesthesia.

results of basic science indicate that regional anesthesia prevents perioperative immunosuppression and reduces postoperative metastatic cancer dissemination. if this would occur in humans, optimised anesthetic management might improve long-term outcome after cancer surgery.

Eligibility criteria:
inclusion criteria: * patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb * signed informed consent exclusion criteria: * age \< 18 years * female patients who are pregnant or nursing * multiple organ failure * contraindications

Keywords: perioperative immunoediting potential predictive biomarkers lymph node dissection