Kornimate/medical-research-clean huggingface dataset:
canadian network for autoimmune liver disease

Conditions: Primary Bilary Cirrhosis (PBC); Autoimmune Hepatitis; Overlap Syndrome

Summary: canal is a longitudinal observational cohort study of patients diagnosed with primary biliary cholangitis (pbc), autoimmune hepatitis (aih), or overlap syndrome. this study creates a nationwide registry and network focusing on high quality long-term follow-up of individual patient data from major canadian centers. primary biliary cholangitis (pbc) and autoimmune hepatitis (aih) are rare and slowly progressive liver diseases associated with development of cirrhosis, liver cancer (hcc) and liver failure requiring liver transplantation or leading to premature death. the rarity and slowly progressive nature of these autoimmune liver diseases make them difficult to study and only a large scale approach combining patient data from multiple centers across canada will allow new insights. the primary aim of the canadian network for autoimmune liver disease is to build a canadian registry of patients with pbc, aih, and overlap syndrome. we capture patient characteristics, laboratory assessments and natural history, patient-reported outcomes including quality of life measures and environmental exposures, response to treatment, and pre- and post-transplant outcomes. we will then identify risk factors associated with critical outcomes for the patient, including response to treatment, progression to transplant, risk of liver cancer, and recurrent disease after transplant. we can identify biomarkers (biochemical indicators of progression of disease) to help diagnose autoimmune liver disease at its earliest stages, ensuring timely treatment and preventing disease progression. canal will provide a better understanding of autoimmune liver diseases, biomarkers predictive of disease progression or non-response to therapy as well as better knowledge of the etiology and pathogenesis. canal will also help to serve as a platform for conducting clinical trials or targeted lab-studies to answer important questions that are unlikely to be evaluated by the pharmaceutical industry.


Eligibility criteria:
inclusion criteria: * diagnosis of primary biliary cholangitis and/or autoimmune hepatitis exclusion criteria: * less than 18 years of age
the efficacy of intravenous immunoglobulin therapy for severe 2019-ncov infected pneumonia

Conditions: 2019-nCoV

Summary: in this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of intravenous immunoglobulin (ivig) in combination with standard care for severe 2019 novel coronavirus (2019-ncov) pneumonia.

in december 2019, viral pneumonia caused by a novel beta-coronavirus (2019-ncov) outbroke in wuhan, china. part of patients rapidly progress severe acute respiratory failure with substantial mortality, making it imperative to develop an efficient treatment for severe 2019-ncov pneumonia besides the supportive care. intravenous immunoglobulin (ivig) has been shown to improve the treatment effect and prognosis of severe infection over the past decades with its capacity of proving passive immunity and anti-inflammatory, immunomodulatory effect. we hypothesized that ivig therapy would improve the prognosis of severe and critically ill patients with 2019-ncov. this single-center, randomized, open-label, controlled trial will evaluate the efficacy and safety of ivig therapy in patients with severe or critically ill 2019-ncov respiratory disease.

Eligibility criteria:
inclusion criteria: * adult aged \>=18years old; * laboratory (rt-pcr) confirmed 2019-ncov infection in throat swab and/or sputum and/or lower respiratory tract samples; * the interval between the onset of symptoms and randomized is within 7 days. the onset of symptoms is mainly based on fever. if there is no fever, cough or other related symptoms can be used; * meet any of the following criteria for severe or critical ill conditions: 1. respiratory rate \>=30/min; or 2. rest spo2\<=90%; or 3. pao2/fio2\<=300mmhg; or 4. respiratory failure and needs mechanical ventilation; or 5. shock occurs; or 6. multiple organ failure and needs icu monitoring; * sign the informed consent form on a voluntary basis. exclusion criteria: * exist of other evidences that can explain pneumonia including but not limited to: influenza a virus, influenza b virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.; * allergy to intravenous immunoglobulin or its preparation components; * patients with selective iga deficiency * women who are pregnant or breast-feeding; * researchers consider unsuitable.
efficacy of celsi warmer for the management of hypothermic newborns

Conditions: Newborn Hypothermia

Summary: the purpose of the study is to evaluate the efficacy of a novel low-cost warming device to provide thermal care for newborn babies with hypothermia in low-resource hospitals. during the study, research participants will receive thermal care via the celsi warmer. aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. the results from this study will allow us to determine if the celsi warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. the research team hopes to demonstrate that the celsi warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.


Eligibility criteria:
inclusion criteria: * is currently being treated at study location * is an inborn admission to the neonatal ward * whose parents or guardians provided a written informed consent * whose parents or guardians providing informed consent are 18 years old or older * has a current weight of greater than or equal to 1.0 kg and less than or equal to 4.0kg * has been identified as in need of thermal care defined as having a moderate hypothermic temperature (32.0-36.0°c) as the last temperature recorded in hospital chart, or during recruitment procedures; and * is unable to be enrolled in kmc for reasons including, but not limited to: 1. mother/guardian unable or unavailable to provide kmc 2. under observation in nicu before transfer to kmc 3. no space in kmc 4. clinician's discretion * may be receiving other medical treatments, including but not limited to, cpap, oxygen therapy, iv fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia via led phototherapy exclusion criteria: * requires mechanical ventilation * deemed in need of intensive care by the hospital staff who is providing care,including but not limited to: 1. neonates with severe anemia and/or any suspected hematological disorders, and/or 2. neonates with obvious congenital anomalies, and/or 3. neonates suspected with hypo/hyperthyroidism or any hormonal disorders * has been diagnosed with birth asphyxia * presents a condition that precludes the use of the temperature sensor and/or abdominal belt including but not limited to, gastroschisis, known umbilical cord infection, known skin infection * whose clinician presents concerns about their participation * is receiving treatment that participation in the study would interfere with, i.e.transferring to kmc
celect vena cava filter clinical trial

Conditions: Pulmonary Embolism; Venous Thromboembolism

Summary: the clinical study will collect data to verify the safety and performance of the cook celect filter in the prevention of pulmonary embolism (pe) in patients with a temporary or permanent high risk of thromboembolism.


Eligibility criteria:
inclusion criteria: * the patient is at high risk for pulmonary embolism and is under consideration for placement of a permanent or short-term ivc filter. * the patient must have a patent internal jugular vein. * the patient or guardian must have given informed consent. * the patient must agree to return for clinical imaging follow-up at 1, 3, 6, and 12 months. * the patient must agree to have a clinical and imaging examination performed prior to filter retrieval. * the patient must agree to return for clinical and imaging follow-up at 30 days and 3 months after filter retrieval. exclusion criteria: * the patient is less than 18 years of age. * the patient is pregnant. * the patient has uncontrollable coagulopathy. * the patient has a life expectancy less than 6 months. * the patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters. * the patient's vena cava diameter is less than 15 mm, measured by vena cava sizing catheters. * the patient has a contrast allergy that can not be adequately pre-medicated. * the patient is simultaneously participating in another investigative drug or device study, or has a previous ivc filter.

Keywords: pulmonary embolism venous thromboembolism inferior vena cava filter ivc pe
effects of the low-level laser therapy on functional capacity of the patients with coronary artery bypass surgery

Conditions: Cardiovascular Diseases

Summary: the low-level laser therapy (lllt) has been used in many inflammatory disorders. more recently the lllt was associated with an improvement in the muscle strength, endurance and functional capacity.but, these effects were described only in health or athletic individuals. in this randomized and controlled clinical trails, the investigators will study the effects of lllt on functional capacity of the patients with coronary artery bypass surgery.

this study will be conducing in a large hospital that is reference in coronary artery bypass surgery. 15 patients will be randomized for placebo or low-level laser therapy (lllt). the functional capacity will be test by test six-minute walk test before and after de lllt. moreover the application of lbp or placebo will be followed by assessments of muscle damage and oxidative stress. one-week interval between the lllt will gave to reduce the influence between the treatments.

Eligibility criteria:
inclusion criteria: * patients in the postoperative period of elective cabg referred for cardiac rehabilitation, which are the 15th and 30th days after surgery without ischemic changes and / or complex arrhythmias on the electrocardiogram, between 40 and 75 years of age who have performed the first surgery. exclusion criteria: * patients with decompensated heart failure; presence of any comorbidity such as: unstable angina; associated neurological disease; moderate respiratory illness to severe pre-diagnosed by the attending physician; active infectious disease or fever; disabling peripheral vascular disease; unstable ventricular arrhythmias; diabetes mellitus; use of cardiac pacemaker, musculoskeletal disease that limits physical activity, patients with a bmi ≥30.
strategies of revascularization in patients with st-segment elevation myocardial infarction (stemi) and multivessel disease

Conditions: Myocardial Infarction; Angioplasty, Transluminal, Percutaneous Coronary; Echocardiography, Stress

Summary: multivessel disease has been reported to occur between 40 and 60% of patients with st-segment elevation myocardial infarction (stemi) and has been associated to a worse prognosis. multivessel revascularization offers a myriad of potential advantages as enhance of the collateral blood flow, greater myocardial salvage, the stabilization of other lesions that can be potentially vulnerable, and the achievement of a complete revascularization, factor that is associated with a better prognosis. on the other hand, the prolongation of procedural duration, the hazard of contrast induced nephropathy and the peri-procedural complications can limit the widespread of this practice. to date, very few observational studies have focused in the multivessel revascularization with disparity of results. whereas ones have observed an increase of adverse cardiovascular events and thus not recommend it, others have shown neutral results. stress echocardiography has been shown to be an adequate technique for the diagnosis of coronary artery disease and could be an appropriate tool for selecting the lesions that need to be revascularized because they induce large areas of ischemia. however, this technique has also limitations like the high operator-dependence. therefore, the investigators sought to study if the complete multivessel revascularization of patients with stemi treated by means of primary percutaneous coronary intervention (pci) has an impact on prognosis compared to a strategy of treating only those non-culprit lesions that produce large areas of ischemia in a stress test.


Eligibility criteria:
inclusion criteria: * typical chest pain lasting \>30 minutes with st-segment elevation \>=1mm in \>=2 contiguous ecg leads or left bundle branch block and presentation \< 48 hours since symptom onset. * patients undergoing rescue pci * patients with effective lysis and coronary angiography in less than 24 hours * presence of other lesion \>=70% in a non-culprit artery. * informed consent exclusion criteria: * significant left main disease * lesions in vessels \< 2 mm * lesions in branches of a main epicardial coronary artery and short irrigation territory * previous coronary artery bypass graft (cabg) * any coronary intervention in the previous month * cardiogenic shock * anatomic features no suitable for coronary intervention * pregnancy

Keywords: myocardial infarction primary angioplasty multivessel disease stress echocardiography
recover-vital: platform protocol, appendix to measure the effects of paxlovid on long covid symptoms

Conditions: Long COVID-19; Long COVID

Summary: this is an appendix of master protocol (nct05595369) designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into covid-19 programs and subsequent treatment plans. this sub-study is a prospective, multi-center, double-blind, randomized, controlled trial evaluating nirmatrelvir/ritonavir (paxlovid) in two dosing durations for the treatment of post-acute sequelae of sars-cov-2 infection (pasc). the study is evaluating potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with pasc, according to the platform protocol objectives. the hypothesis is that persistent viral infection and/or overactive/chronic immune response and inflammation are underlying contributors to pasc and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in pasc symptoms.

for this appendix of the master protocol (nct05595369), participants will be randomized to paxlovid (nirmatrelvir/ritonavir) vs. ritonavir control plus nirmatrelvir-matching placebo. when there are multiple study interventions (sub-studies) available under the master protocol (nct05595369), randomization will occur based on the specific inclusion/exclusion criteria of each appendix.

Eligibility criteria:
see nct nct05595369 for recover-vital: platform protocol level exclusion criteria which applies to this appendix additional appendix level exclusion criteria: 1. known pregnancy\* 2. active or expected breastfeeding during the study 3. known egfr \< 30 ml/min 4. known severe hepatic impairment (child-pugh class c) 5. current use of drugs highly dependent on cyp3a for clearance\*\* and for which elevated concentrations are associated with serious and/or life-threatening reactions and which cannot be interrupted during the time of study administration and within seven days before and after study drug administration 6. current use of potent cyp3a inducers\*\* where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance * a pregnancy test must be performed at the baseline visit for participants who are capable of becoming pregnant. * a guide of drugs that may be contraindicated are listed in section 4 contraindications of the full prescribing information of the eua for paxlovid. https://labeling.pfizer.com/showlabeling.aspx?id=16474\&format=pdf

Keywords: pasc paxlovid
metformin for the prevention of cra recurrence

Conditions: Colorectal Adenoma; Metformin; Chemoprevention

Summary: most of the sporadic colorectal cancer (crc )develop from colorectal adenoma (cra), patients with cra have a high risk of recurrence and development of metachronous cra or crc after removal, therefore, the investigators conducted this clinical trial to explore the chemoprevetion effect of metformin for cra recurrence after removal.

colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. the effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated. metformin is a widely used diabetes medicine. in recent years, anticancer activity of metformin has been explored. the aim of this study is to investigate the effect of metformin on the recurrence of colorectal adenomas by conducting a randomized, placebo-controlled, prospective clinical.

Eligibility criteria:
inclusion criteria: 1. aged 40-80 years without diabetes; 2. cras removed without recurrence before recruitment; 3. must sign the consent form after being fully informed and understanding the purpose and procedure of this study. exclusion criteria: 1. familial adenomatous polyposis (fap) or hereditary non-polyposis colorectal cancer (hnpcc, lynch syndrome); 2. regularly taking aspirin, nonsteroidal anti-inflammatory drugs (nsaids), cyclo-oxygenase 2 (cox2) inhibitors, calcium or vitamin d; 3. have a history of gastrointestinal surgery; 4. have severe heart, liver or kidney disease ; 5. have cancer history; 6. women with pregnant, during breast-feeding period, or with expect pregnancy; 7. diabetes（taking diabetes medicines or hba1c\>6.5%); 8. inflammatory bowel disease; 9. mental illness; 10. intolerant to metformin; 11. cannot tolerate colonoscopy; 12. staffs in this clinical trial; 13. poor bowel preparation for colonoscopy or the examination time is shorter than 6 minutes; 14. unsuitable for inclusion by the investigator
improving rehabilitation in sarcopenia (iris)

Conditions: Sarcopenia

Summary: this randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia

this randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin d and calcium concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia

Eligibility criteria:
inclusion criteria: * age 65 years or older * admission for physical rehabilitation * sarcopenia, measured with bioelectrical impedance assessment (bia) + handgrip strength and gait speed * mini mental state examination ≥18 * informed consent exclusion criteria: * any malignant disease during the last five years * known kidney failure (previous glomerular filtration rate \<30 ml/min); * known liver failure (child b or c) * psychiatric disease * endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis) * indications related to the study product: more than 10 µg (400 iu) of daily vitamin d intake from medical sources more than 500 mg of daily calcium intake from medical sources. adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study. * known allergy to milk, milk products or other components of the proposed interventions * indication to or ongoing artificial nutrition support * inclusion in other nutrition intervention trials * investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements * refusal
intraductal papillary mucinous neoplasm with malignant change

Conditions: IPMN

Summary: purpose: to investigate diagnostic performance of ct and mr in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012. hypothesis: according to 2012 consensus guidelines, enhanced solid component and main pancreatic duct size of larger than 10 mm will be significant.

1. purpose * to investigate diagnostic performance of ct and mr in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012 2. enroll criteria * patient who is suspected to have pancreas ipmn on imaging * interval between imaging study and surgery is less than 2 months * who is scheduled for surgery due to ipmn

Eligibility criteria:
inclusion criteria: * patients who is suspected to have ipmn by imaging study or clinician * time interval between imaging study and surgery less than 2 months exclusion criteria: * patients who have pathology results not by surgery * who is less than 20 years old * who cannot voluntarily agree study design
early versus conventional cessation of hydrocortisone in septic shock

Conditions: Septic Shock; Adverse Event; Hydrocortisone; Hyperglycemia; Hypernatremia; Muscle Weakness; Superimposed Infection

Summary: septic shock is one of the causes of death in icu and hospital. refractory shock is the problem which healthcare providers should recognize though it is difficult to handle with. the corticosteroid called hydrocortisone is one of the treatment in refractory septic shock which requires vasopressor to maintain blood pressure. in recovery phase of septic shock and weaning off vasopressor, there is no definite way to taper off hydrocortisone.

according to secondary outcomes of several studies analyzed in systemic review was shown adverse events from corticosteroid uses including hyperglycemia, hypernatremia, muscle weakness, and superimposed infection. this trials will compare composite adverse events in early versus conventional cessation of hydrocortisone in septic shock.

Eligibility criteria:
inclusion criteria: * patient \>= 18 years old * diagnosis septic shock from the definition of sepsis iii criteria in intensive care unit or medicine ward or surgical ward at siriraj hospital * received at least 1 catecholamines and hydrocortisone at least 200 mg/d * maintain mean arterial pressure \>= 65 mmhg even if titrate down catecholamines until low dose (\<=0.1 mcg/kg/min) exclusion criteria: * patient sign do not resuscitation and terminally ill * pregnancy * need long term steroid use due to other medical condition

Keywords: septic shock composite adverse events hydrocortisone hyperglycemia hypernatremia muscle weakness superimposed infection