Kornimate/medical-research-clean huggingface dataset:
envafolimab as first-line treatment of aged patients in advanced nsclc

Conditions: Non-small Cell Lung Cancer Stage IV

Summary: explore the efficacy and safety of envafolimab in first line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer with high pd-l1 expression, view to providing better treatment options for elderly patients with high pd-l1 expression and improving the survival and prognosis of patients .


Eligibility criteria:
inclusion criteria: * signed written informed consent. * age strictly at least 70 years. * cytologically or histologically proven nsclc(adenocarcinoma, epidermoid carcinoma, large-cell carcinoma) of locally advanced (stage iiib/iiic), metastatic, or relapsing (stage iv) according to the american joint committee on cancer staging handbook. * presence of at least one measurable target lesion (recist rules) in a non irradiated region. * no previous systemic chemotherapy for lung cancer. * pd-l1≥50% in tissue samples detected by immunohistochemistry. * ps 0 or 1. * life expectancy sup 12 weeks. * normal hematologic function. exclusion criteria: * egfr-sensitive mutations or alk rearrangements * previous treatment with immune checkpoint inhibitors * presence of symptomatic brain metastases； * chinese patent medicine with anti-lung cancer indications or immunoregulatory drugs (including thymopeptide, interferon and interleukin, except for the local use of pleural effusion control) for systemic treatment； * another previous or concomitant cancer, except for basocellular cancer of the skin or treated cervical cancer in situ； * concurrent administration of one or several other antitumor therapies； * concurrent participation in another clinical trial； * active autoimmune disease requiring systemic treatment occurred within 2 years prior to initial； * systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to initial administration； * contraindication to the study drugs； * has not fully recovered from toxicity and/or complications caused by any intervention prior to the commencement of treatment (i.e., grade 1 or baseline, excluding fatigue or hair loss); * a history of human immunodeficiency virus (hiv) infection; * untreated active hepatitis b (defined as hbsag positive and hbv-dna copy number detected greater than the upper limit of normal value in the laboratory of the research center); * active hcv infected; * recent vaccination within 30 days before the first administration (cycle 1, day 1); * other severe concurrent disorders that occurred during the prior six months before enrollment (myocardial infection, severe or unstable angor, nyha class 3 or 4 congestive heart failure, transient or constituted cerebral ischemic attack, psychiatric or neurological disorders preventing the patient from understanding the trial, uncontrolled infections).
the role of levosimendan as inotropic agent in acute aluminum phosphide-induced cardiotoxicity

Conditions: Acute Myocarditis

Summary: to evaluate the potential role of levosimendan as an inotropic agent in aluminum phosphide-induced cardiotoxicity

aluminum phosphide (alp) is a well-known fumigant known also as rice pill or wheat pill. it is considered an ideal pesticide since it is effective to preserve stored grains against insects and rodents without leaving residues, in addition to its availability and low cost. in egypt, it has become a common method of suicide over the last few years because it is cheap and easily accessible. cardiomyocytes are one of the main targets for alp. alp-induced cardiotoxicity involves detrimental effects such as direct myocardial tissue damage, hypoperfusion, myocarditis, pericarditis, and arrhythmias leading to circulatory failure. levosimendan, an inotropic agent, enhances cardiac contractility through calcium sensitization with minimal oxygen demand and, in turn, decreases the risk of arrhythmia. however, limited studies have investigated the role of levosimendan in the treatment of alp induced cardiotoxicity.

Eligibility criteria:
inclusion criteria: patients with acute alp intoxication admitted to icu of pcc-asuh and developed cardiotoxicity with poisoning severity score (pss) 2 (moderate) or 3 (severe) that led to cardiogenic shock and necessitated administration of vasoactive medications exclusion criteria: * pregnant patients * the presence of pre-existing diseases such as hematologic, pulmonary, hepatic, renal, immunologic, central nervous system, or endocrine system disorders that made patients unsuitable for the present study. * patients with underlying cardiac disease and ecg changes, especially prolonged qtc intervals. * patients co-ingested drugs or toxins with cardiovascular toxicity. * patients had been previously administered with inotropic agent other than agents under the current study as a preconsultation treatment. * patients had received any other investigational medicinal products within 30 days or were enrolled in any other interventional trials with the potential to interact with levosimendan or affect alp induced cardiotoxicity
somatic mutation in chronic liver disease

Conditions: Chronic Liver Disease; Somatic Mutation

Summary: deaths from chronic liver disease are rising in the uk and around the world. the leading causes are alcohol-related liver disease, metabolic-dysfunction associated steatotic liver disease (masld, formerly known as 'non-alcoholic fatty liver disease') and viral hepatitis. chronic liver disease puts people at significantly increased risk of liver cancer, which in the uk has a 5 year survival of under 15%. little is understood about how liver cells acquire genetic changes, called somatic mutations, as they progress from healthy cells, to disease, to cancer development. this study aims to investigate these somatic mutations across different causes of chronic liver disease, and different stages of liver disease. the investigators hope this will help us to understand how different insults to the liver put the liver cells under different pressures, resulting in varying genetic changes. by understanding these changes specific to disease aetiology and stage, novel genetic targets may be identified which assist to focus research in identifying specific prognostic, diagnostic and therapeutic tools in chronic liver disease, and improve outcomes for patients. tissue, surplus to clinical requirement, from patients were undergoing liver biopsy, liver resection or liver transplantation (tissue sampling from explanted liver) collected by collaborators at university of texas southwestern will undergo genomic sequencing at the wellcome sanger institute.


Eligibility criteria:
inclusion criteria: pre-collected cohorts of liver tissue collected from adults (male and female) with consent and ethical approval for use in research. exclusion criteria: anything outside of the above including samples other than liver tissue, samples where there is no consent or ethical approval for use in research and/or samples from children.

Keywords: somatic mutations liver
induction treatment of proliferative lupus nephritis with leflunomide combined with prednisone

Conditions: Nephritis, Lupus

Summary: lupus nephritis accounts for the most morbidity and mortality in patients with sle. glucocorticoids combined with cyclophosphamide (cyc) are effective for the treatment of patients with proliferative lupus nephritis and have been the immunosuppressive regimen of choice for many years. however, some patients do not respond well to the regimen, and adverse effects of cyclophosphamide limit its use in certain patients. leflunomide is a novel immunosuppressive agent currently used in the treatment of rheumatoid arthritis.there were a few pilot observational studies and reports suggesting leflunomide was also safe, well-tolerated and may be effective in sle patients without important organ involvement. it has not been shown if leflunomide can be used in the treatment of patients with lupus nephritis. we therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of leflunomide compared with cyclophosphamide in the treatment of patients with biopsy proven proliferative lupus nephritis.


Eligibility criteria:
inclusion criteria: * all patients were diagnosed as sle according to the updated criteria of american college of rheumatology in 1997, had a systemic lupus erythematosus disease activity index (sledai)equal or greater than 8; had evident renal diseases and biopsy-documented diffuse proliferative or focal proliferative lupus nephritis, with or without coincident membranous nephropathy, and pathological activity index (ai)equal or greater than 4 exclusion criteria: * patients who had received cyclophosphamide within the previous 3 months, cerebral lupus, severe infection, liver disease, pregnancy, and anticipated poor compliance with the protocol.
coordinated healthcare interventions for childhood asthma gaps in outcomes

Conditions: Asthma

Summary: chicago is an epicenter for asthma health disparities in the u.s., with african-american children 5-11 yrs bearing a disproportionate share of the burden. among the most visible of these disparities is the high rate of visits to the emergency department (ed) for uncontrolled asthma. clinical uncertainties regarding the real-world effectiveness of guideline recommendations for ed discharge and strategies to reduce environmental triggers at home contribute to practice variation and poor adherence to guidelines. the chicago plan tests both ed- and home-level interventions to improve clinically meaningful outcomes in a minority pediatric ed population with uncontrolled asthma.


Eligibility criteria:
inclusion criteria (all of the following): 1. child is 5-11 years of age (a population in whom a diagnosis of asthma is generally reliable, and in whom exacerbations are common); 2. child is presenting to the ed, urgent care center, or observation unit at a participating clinical center (anne and robert h. lurie children's hospital of chicago, sinai health system's mount sinai hospital, john h. stroger jr. hospital of cook county health \& hospitals system, rush university medical center, university of chicago medicine comer children's hospital, and the university of illinois hospital \& health sciences system); 3. child is treated with at least 1 dose of an inhaled or nebulized short-acting bronchodilator (quick-relief medication); 4. child received systemic corticosteroids in the ed or the caregiver reported at least 1 additional acute care visit for asthma in the previous 6 months (defined as an asthma-related ed visit or urgent care visit, or course of systemic corticosteroids); 5. child and caregiver approached at least 1 hour after receipt of the first dose of quick-relief medication or systemic corticosteroids, whichever occurred first; 6. diagnosis of asthma exacerbation by treating clinician; 7. treating ed clinician indicates the child is likely to be discharged to home; and 8. caregiver reports that english or spanish is the preferred language at home. exclusion criteria (none of the following): 1. caregiver declines to provide informed consent, or the child declines to provide assent; 2. child is admitted to an intensive care unit or transferred to another healthcare facility; 3. child or another member of the child's primary household is a current or previous participant in the chicago plan; 4. child is enrolled in another study involving a health-related intervention; 5. a chw is already visiting the home as part of another program; 6. child does not reside in chicago.

Keywords: community health worker emergency asthma
mycophenolate mofetil in membranous nephropathy

Conditions: Glomerulonephritis, Membranous

Summary: patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (esrd). treatment with cyclophosphamide is currently used as a treatment modality. mycophenolate mofetil is a new immunosuppressive agent with fewer side effects. in this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. the outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.


Eligibility criteria:
inclusion criteria: * membranous nephropathy * serum creatinine (screat)\> 1,5 mg/dl or ecc \ 50% * proteinuria \> 2 g/day exclusion criteria: * systemic diseases * pregnancy wish * active infection * liver dysfunction * abnormal hematology lab * unstable angina * nonsteroidal anti-inflammatory agents (nsaids)

Keywords: membranous nephropathy mycophenolate mofetil cyclophosphamide prednisone
hypoglycemia biomarkers to predict timing of a hypoglycemic event

Conditions: Hypoglycemia

Summary: the study aims to obtain a panel of biomarkers from hypoglycemic diabetic patients with either type 1 or type 2 diabetics and from control patients with type 1 or type 2 diabetes who didn't have hypoglycemia in the last 72 hours.

primary endpoint is establishing a panel of biomarkers from 100 hypoglycemic diabetic patients with type 1 or type 2 diabetes during the incidence of hypoglycemia by taking a single blood sample to be analyzed for hba1c, ldl, hdl, triglycerides, crp, cbc and biochemical analysis including liver and kidney function tests. in addition to 5 ml serum sample to be centrifuged and stored in rcsi lab. inpatient hypoglycemic patients may also be included in group of hypoglycemia and will be required to have a serial of blood samples taken to be analyzed on the 1st hour, 2nd hour, 3rd hour and 4th hour after the hypoglycemic event. secondary endpoint involves recruitment of 100 control diabetic patients with type 1 or type 2 diabetes to establish a panel of biomarkers by obtaining a blood sample for the hba1c, ldl, hdl, triglycerides, crp, cbc and biochemical analysis including liver and kidney function tests to include 50 subjects fasting overnight and the other 50 subjects to be non-fasting but without having hypoglycemia at the time of recruitment or in the last 72 hours.

Eligibility criteria:
inclusion criteria: inclusion criteria for diabetes subjects with hypoglycemia * diagnosed of type 2 diabetes or type 1 based on the who guidelines patient's age from 21-75 years old * able to say when the hypo had occurred (free style libre in the outpatient setting, or documented blood glucose less than \< 4 mmol/l (\<70 mg/dl) as an inpatient inclusion criteria for diabetes subjects without hypoglycemia: * diagnosed of type 2 diabetes or type 1 based on the who guidelines * patient's age from 21-75 years old * no hypoglycemia or hypoglycemia unawareness. exclusion criteria: * egfr less than 45 ml/min * liver enzymes 3 folds greater than upper limit * pregnancy * patients on steroids or atypical antipsychotics or cyclosporine/tacrolimus or other medications that may mask hypoglycemia exclusion criteria for diabetes subjects with hypoglycemia * unable to determine when hypoglycemic event had taken place * hypoglycemic unawareness * severe hypoglycemic event in the last 3 months exclusion criteria for diabetes subjects without hypoglycemia * hypoglycemic event in the preceding week * hypoglycemic unawareness

Keywords: type 1 diabetes type 2 diabetes hypoglycemia biomarkers
effectiveness of mindfulness-based internet intervention still me

Conditions: Post-traumatic Stress Disorder

Summary: the aim of the study is to assess the effectiveness of a mindfulness-based internet intervention for post-traumatic stress disorder symptoms.

intervention is going to take the form of a mindfulness-based internet intervention consisting of eight modules. the themes include awareness and nonjudgment of senses, emotions, and thoughts. these themes were chosen after considering topics that might be the most useful for individuals who experience post-traumatic disorder symptoms. each module consists of psychoeducation and exercise (audio records mostly) parts. psychologist can be reached on demand. the effect of the intervention will be compared against a waiting list control group. intervention is in lithuanian.

Eligibility criteria:
inclusion criteria: * at least 18-years-old; * understand lithuanian; * internet access and device for that; * at least one traumatic event during lifetime; * post-traumatic stress disorder symptoms. exclusion criteria: * an acute case of psychiatric care; * interpersonal violence; * alcohol / drug addiction; * cannot participate.

Keywords: ptsd mindfulness efficacy internet intervention
efficacy of thermoprofen in patients with mild to moderate pain associated with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: thermoprofen is a transdermal ketoprofen patch that is integrated with a long-lasting chadd (controlled heat-assisted drug delivery) unit for the treatment of chronic pain associated with osteoarthritis. this study will evaluate thermoprofen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.

the primary objective of the study is to compare the efficacy of thermoprofen™ against two other experimental treatments. the treatment may be thermoprofen (matrix transdermal ketoprofen patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.

Eligibility criteria:
inclusion criteria: * patient is 18 through 75 years of age * patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year. exclusion criteria: * patient has a known allergy to nonsteroidal anti-inflammatory drugs (nsaids, including aspirin). * patient has asthma that has been induced or made worse by the use of aspirin or nsaids. * patient has a relevant history of serious gastrointestinal disease. * patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control. * patient is taking warfarin, heparin, or low molecular weight heparin. * patient has received oral, intramuscular, intravenous, intra-articular, or soft-tissue administration of steroids within 1 month of study enrollment (or within 2 months, if in the target joint). * patient has received intra-articular visco-supplementation (in target joint) within 6 months of study enrollment.

Keywords: osteoarthritis pain
function of implanted glucose sensor 2

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. the study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.


Eligibility criteria:
inclusion criteria: * either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become pregnant * diabetes diagnosis of type 1, or type 2 using insulin * under the routine care of a physician for diabetes treatment * able to understand and follow directions * history of compliance with diabetes care regimen * able to comply with study requirements regarding planned clinical visits and exams * in good physical condition without major medical concerns or blood chemistry abnormalities exclusion criteria: * mental disorders that might affect compliance to protocols * diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin or (2) insulin use restricted to a single daily injection of long-acting insulin or (3) control by diet/exercise regimen alone * history of intolerance or sensitivity to any of the device materials * history of any adverse reaction or allergy to any of the drugs/agents utilized in the study procedures * history of recurrent skin infections

Keywords: diabetes mellitus requiring insulin
evaluation of postural exercises in the treatment of temporomandibular disorders

Conditions: Occlusal Splints; Temporomandibular Disorders (TMD)

Summary: fifty-seven patients diagnosed with internal temporomandibular derangement will be included in the study and divided into three groups. all patients will be treated with a proven-effective occlusal splint. the first group will receive only occlusal splint therapy and will serve as the control group. the second group will receive occlusal splint therapy combined with rocabado exercises, while the third group will receive occlusal splint therapy combined with postural exercises. before the treatment process, all patients will complete the temporomandibular disorders diagnostic criteria (tmd-dc) form. pain intensity will be measured using the visual analog scale (vas), pain thresholds will be assessed using an algometer, and the following evaluations will be performed: cervical posture assessment (craniovertebral angle with goniometer)-cervical range of motion assessment (c-rom)-cervical deep flexor muscle endurance test-neck disability assessment (ndi - neck disability index)-psychiatric assessment (hads - hospital anxiety and depression scale). after two months, patients will be recalled, and all tests will be repeated. the effectiveness of the three treatment protocols will then be evaluated.


Eligibility criteria:
inclusion criteria: * being diagnosed with internal temporomandibular disarrangement * aged 18 years or older * willingness to participate in the study * ability to speak and understand turkish, with no communication difficulties severe enough to impede understanding of the exercises exclusion criteria: * history of acute trauma in the tmj or surrounding area * tmj dysfunction caused by a neurological condition * history of surgical/invasive procedures or treatments on the tmj * presence of infection or tumoral structures within intraoral structures * history of tooth loss or use of dental prostheses * history of surgical procedures in the cervical region

Keywords: temporomandibular disorders rocabado occlusal splints posture excercise
quality of life in daxas-treated patients older than 18 years with severe chronic obstructive pulmonary disease (copd) (dacota)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a progressive and largely irreversible lung disease characterized by chronic bronchitis and/or emphysema, resulting in breathlessness, cough and sputum. as copd progresses, patients experience increasing deterioration of their health-related quality of life, with greater impairment in their ability to work and declining participation in social and physical activities. the aim of this non-interventional study is to evaluate data on quality of life in copd patients in germany in a real life medical setting under therapy with the phosphodiesterase-inhibitor (pde-4) roflumilast (daxas). evaluation is based on two copd specific questionnaires to assess the patient's health status over six months. during the study, lung function measurements such as spirometry will be conducted according to common medical standard. daxas (tablet) will be administered once daily. the study will provide further data on the safety and tolerability of daxas.


Eligibility criteria:
main inclusion criteria: * severe copd main exclusion criteria: * child pugh (classified b and c)

Keywords: copd quality of life lung function spirometry roflumilast daxas severe copd