Kornimate/medical-research-clean huggingface dataset:
noninvasive negative pressure ventilation to support failing fontan physiology

Conditions: Failing Fontan Physiology; Pediatric Congenital Heart Disease

Summary: the purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with fontan failure using modern negative pressure ventilators


Eligibility criteria:
inclusion criteria: 1. patients with fontan physiology with clinical evidence of fontan failure as defined by those with one of the following in addition to fontan circulation: new york heart association class ii, fluid retention, cyanosis, protein losing enteropathy, renal/hepatic dysfunction and/or subjectively qualify for hemodynamic assessment (by primary cardiologist). exclusion criteria: 1. patients which will likely require intubation for catheterization 2. severely depressed systemic ventricular systolic function 3. baseline airway obstruction 4. plastic bronchitis 5. significant outflow obstruction
effect and safety of benaglutide or metformin in patients with simple obesity who have inadequate weight control

Conditions: Obesity; Drug

Summary: this is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of benaglutide or metformin in patients with simple obesity who have inadequate weight control.

this is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of benaglutide or metformin in patients with simple obesity who have inadequate weight control. screening will be made to select eligible participants before intervention. patients were randomly assigned to one of two groups(metformin or benaglutide) for therapies for 12 weeks including a two-week dose adjustment period and a 10-week dose stabilization period. lifestyle interventions will be maintained during the treatment period. subjects are followed up every 4 weeks for examinations.at the end of the study, data will be collected and analyzed.

Eligibility criteria:
inclusion criteria: (1)20 years old≤70 years old; (2) simple obesity, gender is not limited; (3) 28.0≤bmi≤37.5kg/m2; (4) before the screening period, the body weight was controlled by lifestyle interventions (diet and exercise) for at least 3 months, and weight was decreased by \<5% from baseline; (5) agree to sign the informed consent form; exclusion criteria: 1. accurately diagnosed as having type 1 or type 2 diabetes according to the who 1999 diagnostic criteria; 2. use weight loss drugs within 3 months before screening; 3. metformin was used within the first 3 months of screening; 4. malignant tumors (excluding basal cell or squamous cell carcinoma treated) within 5 years before enrollment 5. alanine aminotransferase or aspartate aminotransferase \> 3 times the upper limit of normal or total serum bilirubin (tb) \>34.2 μmol/l (\>2 mg/dl) 6. patients with moderate/severe renal impairment or end-stage renal disease (egfr \ 1.40 mg/dl); 7. severe heart, lung, nervous, mental and infectious diseases; 8. pregnancy, lactation and recent pregnancy plans; 9. alternate or chronic systemic corticosteroid therapy, defined as treatment with any dose of systemic corticosteroids within 3 months of enrollment visit v1 \> 4 weeks 10. history of alcohol abuse, history of abuse of active drugs (opioids, analgesics, etc.) within 6 months before enrollment; 11. give any other test drug within 30 days before enrollment or within 5 half-lives of other test drugs; 12. patients with past history or family history of medullitary thyroid cancer (mtc) and patients with type 2 multiple endocrine tumor syndrome (men2); 13. inability to tolerate benalutide, metformin; 14. any influence of the investigator's judgment on enrollment.

Keywords: metformin benaglutide
clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp

Conditions: Scalp Psoriasis

Summary: the primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.


Eligibility criteria:
inclusion criteria: * subjects with diagnosis of moderate to severe plaque psoriasis of the scalp exclusion criteria: * subjects who need systemic treatment for their body psoriasis * subjects who have surface area involvement too large (\>20% body surface area \[bsa\]) that would require more than 50 grams per week of study product
a phase 2 study to evaluate the safety and efficacy of lou064 in patients with moderate to severe sjögren's syndrome

Conditions: Sjögren Syndrome

Summary: this was an adaptive design phase 2 study to establish safety and efficacy; and to characterize the dose-response of lou064 in subjects with moderate to severe sjögren's syndrome. lou064 is an oral bruton's tyrosine kinase (btk) inhibitor.

this study was planned as an adaptive phase 2 randomized, double-blind, placebo-controlled, multi-center, integrated dose-ranging study to evaluate the safety and efficacy of multiple remibrutinib doses in patients with moderate to severe sjögren's syndrome. of the initially planned two parts, only part 1 of the study was conducted. in part 1, the highest expected biologically active single dose of remibrutinib (100 mg) was tested in two different dosing regimens, a once daily dose (qd) or twice daily dose (bid), and compared to the placebo group. each patient in part 1 of the study underwent a screening period of up to 6 weeks, a treatment period of 24 weeks, and a follow-up period of 30 days post-treatment before the end of study (eos) visit. the total duration for each patient in the study, including screening, was up to 35 weeks. for the treatment period, patients were randomized in a 1:1:1 ratio to one of the 3 treatment groups: remibrutinib 100 mg bid, remibrutinib 100 mg qd and placebo.

Eligibility criteria:
inclusion criteria: * diagnosis of sjs according to the 2016 acr/eular criteria * screening essdai (based on weighted score) ≥ 5 derived from 8 domains * screening esspri ≥ 5 * seropositive for anti-ro/ssa antibodies at or within 3 months prior to screening * unstimulated salivary flow \> 0 ml/min. exclusion criteria: * sjögren's syndrome overlap syndromes with another autoimmune disease as primary illness * dmards or kinase inhibitors within 3 months prior to baseline above certain doses or maintained during study * rituximab or other b cell depleting drug within 12 months of screening . * current use of prednisone or equivalent \> 15mg/d or dose change within 2 weeks prior to screening * use of medication known to cause, as a major side effect, dry mouth / eyes * hiv, hepatitis c, hepatitis b, known or suspected history of an ongoing, chronic or recurrent infectious disease such as tuberculosis

Keywords: lou064 remibrutinib sjogren syndrome dry eye syndromes pathological processes arthritis joint diseases musculoskeletal diseases rheumatic diseases xerostomia salivary gland diseases mouth diseases stomatognathic diseases lacrimal apparatus diseases eye diseases connective tissue diseases autoimmune diseases immune system diseases
post-market clinical study to confirm safety and performance of purastat absorbable haemostatic material for the management of bleeding in liver surgery

Conditions: Liver Resection

Summary: the objective of this post-market clinical follow-up study is to collect medical information on patients implanted with purastat®, according to each participating institution's procedures and standards of care.


Eligibility criteria:
main inclusion criteria: * male or female patient ≥ 18 years old * subject have been informed and understand the nature and extent of the study, agree to its provisions and have provided written approved informed consent * patient undergoing elective primary or redo open liver resection for hepatic colorectal metastases with a curative intent * subject, who, in the opinion of the clinical investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up. main exclusion criteria: * known allergy or hypersensitivity to any component of the investigational treatment purastat® * pregnant or interested in becoming pregnant during the duration of the study, or breast feeding * concurrent participation in another clinical study with a medical device or medicinal product with interfering endpoints
exparel or lidocane as local anesthetic in patients undergoing pleuroscopy with pleural biopsy and indwelling pleural catheter placement

Conditions: Malignant Pleural Neoplasm

Summary: this phase ii trial investigates the effect of exparel compared to lidocane as a local anesthetic in patients who are undergoing pleuroscopy with pleural biopsy and indwelling pleural catheter placement. this trial aims to see whether exparel or lidocane is able to make patients more comfortable.

primary objective: i. to compare global chest pain score (measured on the visual analog scale \[vas\] scale) post-procedure and post procedural chest pain (measured on the numerical rating scale), at the time of discharge from recovery between liposomal bupivacaine (exparel) and 1 percent lidocaine. secondary objectives: i. to compare post procedural chest pain (measured on the numerical rating scale) at the time of discharge from recovery, 24 hours and 48 hours post procedure between exparel and 1 percent lidocaine. ii. to assess the change in global chest pain score (measured on the vas scale) from baseline to the time of discharge from recovery, and post procedural chest pain (measured on the numerical rating scale) from baseline over time between exparel and 1 percent lidocaine. iii. to compare the number of narcotics within 24 hours, and from 24 to 48 hours post procedure between exparel and 1 percent lidocaine. outline: patients are randomized to 1 of 2 groups. group a: patients receive liposomal bupivacaine via injection into the intercostal nerve block. group b: patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.

Eligibility criteria:
inclusion criteria: 1. referral to pulmonary services for pleuroscopy with biopsies and ipc placement/chest tube placement 2. age \> 18 exclusion criteria: 1. inability to provide informed consent 2. study subject has any disease or condition that interferes with safe completion of the study including: a. allergic reaction to exparel 3. need for pleurodesis 4. allergies to lidocaine or other local anesthetics. 5. pregnancy 6. advanced liver disease where the clinician deems the procedure unsafe
a novel score to predict risk of symptomatic intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage; Thrombectomy; Stroke

Summary: this study sought to develop and validate a new risk stratification score (henan predicting the risk of intracerebral hemorrhage score, henan-prihs) based on intra-arterial contrast enhanced flat detector ct (ia-cefdct) to predict symptomatic intra-cerebral hemorrhage (sich) after stroke thrombectomy.

the henan-prihs was developed from 95 patients who underwent ia-cefdct and mt for acute anterior stroke. patients were classified as having one of three grades according to the presence of contrast filling within the occluded vascular territory. grade 0 was normal or less contrast filling in affected hemisphere, grade 1 and 2 were small and medium-large area without contrast filling, respectively. the youden index was used to determine the optimum no contrast filling area cutoff for defining grade 1 and 2. the score was subsequently validated in a different population of 208 patients and compared with three established scores.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years, 2. occlusion of internal carotid artery and/or middle cerebral artery (mca) m1 or m2 segments confirmed by cta or mra or dsa, 3. baseline national institutes of health stroke scale (nihss) score ≥ 4 points, 4. mt was performed within 16 hours from stroke onset, 5. baseline ct scan and ia-cefdct scan must be performed; 24 hours post-treatment ct scan was done and when the patient's neurological state had deteriorated. exclusion criteria: 1. bilateral infarcts, 2. history of hemorrhagic stroke, 3. post-procedure ich (including sah) due to iatrogenic complications, 4. missing clinical and demographic data, 5. poor-quality ia-cefdct scans (i.e., motion artifact) that limited accurate identification of the region of interest. bridge treatment (combined intravenous thrombolysis with mt) was not excluded from this study.
a trial of ebus-tbna versus conventional tbna in diagnosis of sarcoidosis

Conditions: Sarcoidosis

Summary: the investigators hypothesize that conventional or ebus-tbna will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy.

diagnostic procedures like transbronchial lung biopsy (tblb), transbronchial needle aspiration (tbna) and endobronchial biopsy (ebb) are routinely used to obtain pathological confirmation of pulmonary sarcoidosis. real-time convex probe endobronchial ultrasound-guided tbna (ebus-tbna) has shown immense potential, however it is costly, labor intensive and still has limited availability, especially in low and middle income countries. in the past, tblb has been the bronchoscopic procedure of choice for diagnosis of sarcoidosis however currently its role is being debated with the advent of ebus. we have observed that ebus even though has high yield yet the optimal diagnosis is obtained only when combined with ebb and tblb. the investigators hypothesize that conventional or ebus-tbna will have equal efficiency in diagnosing sarcoidosis when performed in conjunction with endobronchial and transbronchial lung biopsy. the study compares the diagnostic yield of ebus-tbna (plus ebb and tblb) vs. conventional tbna (plus ebb and tblb) for diagnosis of sarcoidosis.

Eligibility criteria:
inclusion criteria: consecutive patients presenting with clinicoradiological features suggestive of sarcoidosis and an indication for transbronchial needle aspiration exclusion criteria: * pregnancy * hypoxemia (spo2 \<90%) on room air * poor lung function (forced expiratory volume in first second \[fev1\] \<1l) * patients with deranged clotting profile (prothrombin time \>3 seconds above control; activated partial thromboplastin time \>10 seconds above control, platelet count \<50000/µl) * patients already initiated on glucocorticoids * diagnosis of sarcoidosis possible on minimally invasive techniques such as skin biopsy or peripheral lymph node biopsy and failure to provide informed consent
effect of dexmedetomidine on plasmatic cortisol response in transsphenoidal surgery

Conditions: Pituitary Neoplasms

Summary: use of dexmedetomidine in pituitary tumor resection surgery as adjuvant drug and its relation to cortisol levels during postoperative period.

transsphenoidal resection of pituitary tumors is the neurosurgical procedure of choice to remove most of the tumors of the sellar region. sometimes the intervention produces dysfunction of the hypothalamic-pituitary axis, and although most are transient, the risk associated with post-operative hypocortisolism determines its evaluation early in the postoperative period and the possibility of steroidal supplementation posteriorly. it is described that dexmedetomidine can be used as an adjuvant drug in this type of surgery being useful in reduction of total consumption of opioids and anesthetic gases, maintain hemodynamic stability and less time to recovery from anesthesia. due to its sympatholytic effect, dexmedetomidine has been found to alter the intraoperative common neuroendocrine response generating lower levels of cortisol in the postoperative period than patients in which is not used. the main objective of this study is to evaluate corticosteroid axis response (cortisol and adrenocorticotropic hormone) in patients undergoing transsphenoidal surgery under anesthesia with dexmedetomidine. a single-center randomized double-blind clinical trial will be conducted that will compare two groups of patients, one of which will be given dexmedetomidine (dex group) and another group who will receive a placebo (control group). in addition the incidence of perioperative complications (nausea, vomiting, diabetes insipidus), intraoperative hemodynamics and patient comfort. the investigators expect that the normal stress response to surgery measured by cortisol and adrenocorticotropic hormone in the postoperative period will be reduced in the dexmedetomidine arm. this effect should be transient and attributed to use of dexmedetomidine and not to surgery.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i or ii. * pituitary tumour: non-functional macroadenoma, rathke's cleft cyst, acromegaly. * normal hypothalamic-pituitary-adrenal axis by hormone levels measurement previous to surgery. exclusion criteria: * cushing disease. * pituitary apoplexy. * craniopharyngioma. * chronic corticosteroid use. * hemodynamic instability. * altered consciousness (glasgow coma scale score less than 15). * atrioventricular block in any degree. * preoperative bradycardia. * alpha 2 agonist use (clonidine, alpha-methyldopa) * pregnancy or breast feeding. * known allergy to any of the study drugs.

Keywords: dexmedetomidine pituitary transsphenoidal cortisol
efficacy of hfnc as an alternative to cpap therapy in surgical patients with suspected moderate to severe osa

Conditions: OSA

Summary: high flow, humidified, temperature-regulated nasal insufflation is not a new concept. it is used widely in the treatment of hypoxaemic respiratory failure in critically ill patients, as an alternative to non-invasive positive ventilation via face or nasal mask. recently, its use has been extended to the perioperative setting for pre-oxygenation and prolonging apnoeic time to desaturation. both cpap and high flow nasal cannula insufflation devices are licensed for use clinically in singapore. we conduct this pilot study because its perioperative use in our adult osa population is currently not well-defined.

continuous positive airway pressure (cpap) therapy is the only treatment for obstructive sleep apnoea (osa) shown to reduce its long-term adverse effects on the cardiovascular system. however, due to difficult patient-mask interface and discomfort, compliance rate amongst patients with osa is low, and reported to be only between 20-50%. high flow, humidified, temperature-regulated nasal cannula insufflation (of air or oxygen) is a well-documented and safe treatment in intensive care, paediatrics and respiratory medicine for patients with hypoxaemic respiratory failure. its use in adult patients with obstructive sleep apnoea, especially in the perioperative setting is not well studied. our hospital has a ''fast-track'' protocol for osa patients who require surgery. they are started on cpap therapy 2 to 5 days prior to surgery and in the immediate post operative period (ie. perioperatively). if these patients are non-compliant to the cpap mask device, high flow nasal insufflation is a possible alternative treatment. we aim to randomise these patients into 4 groups, receiving conventional cpap face mask or high flow nasal cannula at 3 flow rates, and study them with respect to incidence and number of documented desaturations. in addition, patient satisfaction, compliance to device and any adverse events will be monitored.

Eligibility criteria:
inclusion criteria: * patients aged 21-85 years old presenting for elective surgery. * suspected/possible osa patients who are enrolled in the "fast-track osa protocol" in the pre-assessment clinic * patients started on cpap therapy at least one day pre-operatively * patients who are admitted to the high dependency unit for postoperative monitoring. exclusion criteria: * patients with nasal obstruction. * patients undergoing nasal or facial surgery, or surgery to treat osa (eg. uvulopalatopharyngoplasty). * patients who already require a higher oxygen concentration (fio2 \> 0.21) preoperatively.

Keywords: cpap therapy high flow nasal cannula
il-6 in exercise-induced anorexia

Conditions: Appetitive Behavior; Pediatric Obesity

Summary: this study investigates the effect of high intensity exercise, with and without the inflammation inhibitor, ibuprofen, on plasma levels of il-6 and other selective biomarkers of inflammation and appetite on food intake and subjective ratings of appetite in normal-weight boys.


Eligibility criteria:
inclusion criteria: * 13-18 yrs, healthy, male exclusion criteria: * female, heamatophobia, following a diete, diagnosed with diabetes or other metabolic diseases, scoring ≥11 on an eating habit questionnaire
t2bacteria panel pivotal study

Conditions: Bacteremia

Summary: the purpose of this study is to demonstrate the safety and effectiveness of the t2bacteria panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the t2bacteria panel compared to blood culture results and/or known bacteria positive status of prospectively collected clinical specimens and contrived (i.e. bacteria-spiked) whole blood "clinical samples".


Eligibility criteria:
inclusion criteria: * subject or subject's legally authorized representative (lar) must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them. * subject has had a diagnostic blood culture ordered, per routine standard of care (prospective arm only). * subject is between 18-95 years of age. exclusion criteria: * subject has other co-morbid condition(s) that, in the opinion of the investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study. * subject has had previous specimens tested by the t2bacteria panel with valid results. * treatment of subject with any investigational novel drug compound within 30 days prior to the collection of t2 specimens.