Kornimate/medical-research-clean huggingface dataset:
lazertinib real-world observational study of in pre-treated egfr t790m mutant with advanced non-small cell lung cancer

Conditions: Metastatic Lung Non-Small Cell Carcinoma; EGFR T790M

Summary: * it is to evaluate the safety and effectiveness of a lasertinib(leclaza) single drug in a actual medical environment for patients 1. primary purpose: progression-free survival (pfs) 2. secondary purpose: * objective response rate * time to treatment failure * adverse event (ae), serious adverse event (sae), and adverse event of special interest (aesi) * severity of (s)ae * duration of response (dor) * overall survival (os) * intravenous progressive survival period (intracranial pfs) * relative dose intensity * research design : a multi-center prospective and restrospective cohort study

□ the purpose of the study the study aims to explore the safety, efficacy and resistance of test drugs in patients with local progressive or metastatic epithelial growth factor t790m mutant non-small cell lung cancer who have been treated with epithelial growth factor receptor tyrosine kinase inhibitors. this study is conducted in korea. about 600 patients will be monitored until the first occurrence of disease progression, withdrawal of consent, failure of follow-up investigation, and death. □ research procedures and information gathering items there are no additional procedures performed by participating in this study and information on safety and effectiveness during the administration of rexhraza will be followed up in routine care situations. the information you will receive when you participate in this study is as follows. * subject characteristics, including age, gender, and race * t790m positive mutation status results and types of tests performed and receptors * a related medical history * a physical examination * disease characteristics * history of chemotherapy * associated concomitant medications * administration of a test drug * safety and effectiveness * resistance mechanism in plasma circulation tumor dna

Eligibility criteria:
inclusion criteria: 1. prospective cohort * adults over the age of 19 * easter cooperative oncology group performance 0-4 * patients who are eligible for or are being treated for test medication as per permit: patients with nsclc with local progressive or metastatic egfr t790m mutation who have previously been treated with generation 1 or generation 2 egfr tki * egfr t790m mutation allows for all results identified in tumor tissue or plasma * patients with brain mr within 3 months of study participation 2. rectrospective cohort * adults over the age of 19 * patients who are already using the test drug according to the domestic authorization of the test drug exclusion criteria: * patients who have a history of hypersensitivity to test drugs or drugs of similar chemical structure or similar family to those of test drugs * pregnant women or lactating women * patients participating in other interventional clinical studies
to compare the clinical application of 18f-lnc1007 injection pet/ct and 18f-fdg pet/ct

Conditions: Tumour

Summary: to evaluate the safety of 18f-lnc1007 injection in the diagnosis of suspected tumor, initial stage, or recurrence monitoring; to explore the biological distribution of 18f-lnc1007 injection in patients; to compare the diagnostic efficacy of 18f-lnc1007 injection pet/ct versus 18f-fdg pet/ct imaging in patients with tumor with clinical suspicion, initial stage, or recurrence monitoring.

this is a prospective, controlled, open-label (with blind members), single-center clinical trial to evaluate the diagnostic efficacy and safety of 18f-lnc1007 injection pet/ct for suspected tumor or tumor initial staging, recurrence monitoring, etc.

Eligibility criteria:
inclusion criteria: * (1) age ≥18 years old; (2) clinically suspected or confirmed tumor patients; (3) as judged by doctors, the expected survival time is 3 months; (4) voluntarily sign informed consent; (5) willing and able to follow the research protocol; (6) the subject must be able to lie on the scanning bed for at least 1 hour. exclusion criteria: * (1) known allergic history to 18f-lnc1007 injection; (2) patients who cannot tolerate intravenous drug administration (such as needle fainting and blood fainting history); (3) those who are not suitable for pet/ct and other imaging examinations or cannot complete them due to special reasons, including claustrophobia and radiophobia; (4) pregnant and lactating women; (5) workers who are exposed to radiation for a long period of time; (6) serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis; (7) participating in other interventional clinical trials within 1 month before screening; (8) patients undergoing chemotherapy, immunotherapy or molecular targeted therapy; (9) there are other circumstances that the researcher considers inappropriate to participate in this study.
pharmacokinetics of voriconazole in adult ecmo patients

Conditions: Aspergillosis; Influenza; Covid19

Summary: given the high burden of fungal co-infection in patients admitted to icu and improved outcomes with prompt anti-fungal treatment, it is of vital importance that the doses of anti-fungal are optimum to improve the dismal outcome of influenza/covid-19 associated pulmonary aspergillosis. due to the reported difficulties in dosing appropriately in ecmo patients, a prospective observational study is required to accurately evaluate the pharmacokinetics of voriconazole in patients supported on ecmo. this is to ensure that the dose of voriconazole is optimised to improve efficacy and reduce toxicity.

a single centre, open label, prospective, observational, pharmacokinetic study of voriconazole administered to adults (aged \> 18 years) supported on ecmo. this is a low-interventional study. there will be no treatment changes as a result of participation in this study. the decision to initiate voriconazole therapy will be taken independent of this study protocol. intravenous voriconazole will be prescribed according to the approved dose in the smpc. all adults requiring voriconazole therapy will be eligible for recruitment into the study. the only additional procedure in this study will be to take a total of 5 blood samples across 3 occasions/sampling windows (day 1-4, day 6-9 and day 11-14) to determine plasma concentrations of voriconazole. in addition, a single buccal swab to determine the cyp2c19 genotype will be undertaken during the course of icu stay.

Eligibility criteria:
inclusion criteria: 1. adults aged ≥18 years 2. admitted to icu on ecmo support 3. positive influenza or sars-cov-2 pcr from nasal, throat swab, bal or other respiratory specimen. 4. positive invasive aspergillosis infection (positive aspergillus species culture from respiratory specimen or positive serum galactomannan) or strong clinical suspicion of invasive aspergillosis infection based on symptoms, ct, cxr. exclusion criteria: 1. no participants \< 18 years of age 2. not requiring ecmo support 3. no positive influenza or sars-cov-2 results 4. any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Keywords: voriconazole extracorporeal membrane oxygenation
masitinib in primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to evaluate the activity of oral ab1010, administered at two dose levels during 3 years to patients with primary or secondary progressive multiple sclerosis.


Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis either primary progressive or secondary progressive without relapse within 2 years before inclusion. 2. patients with edss score in the range of 2 to 6.5, inclusive 3. edss progression ≥ 1 point within 2 years before inclusion exclusion criteria: 1. disease other than ms responsible for clinical signs and/or mri lesions 2. secondary progressive ms with relapse in the 2 years before inclusion 3. treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation 4. treatment with oral or systemic corticosteroids or acth within four weeks prior to treatment allocation. 5. active current bacterial, viral (including hepatitis b and c, hiv, ebv, cmv, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection

Keywords: primary progressive multiple sclerosis relapse-free secondary progressive multiple sclerosis
preoperative imaging of neuroendocrine tumors

Conditions: Neuro-endocrine Tumors; Small Intestine Cancer

Summary: neuro-endocrine tumours (net) are the most frequent tumours of the small intestine. in spite of their small size, these tumours have the particularity of forming mesenteric metastasis and ganglionic secondary lesions along the superior mesenteric axis, which is in close proximity to the superior mesenteric artery (sma). surgery is the only curative treatment. the complete resection being a factor for good patient prognosis, risks of subsequent local complications (occlusion, bleeding) must be discussed. the limiting factor for resectability is arterial vascular invasion considering the risk of postoperative small bowel syndrome. at the moment, the choice of imaging examination and its protocol is not standardized, nor the description of the tumoral mesenteric and ganglionic extension, especially the criteria defining a lymph node as lymphadenopathy. in addition, the complexity of sma's anatomy and the absence of criteria for arterial invasion defining arterial invasion may lead to a misinterpretation of the preoperative imaging , and thus to an incomplete planning of the surgical procedure. to correct this absence of radiological standardization, the investigating team has developed a reading grid for computed tomography (ct) aimed to facilitate preoperative planning of small bowel net. the main objective of the current study is to improve the semiotic description of the mesenteric and ganglionic tumoral extension of small intestine net using a technically optimized imaging examination and a standardized reading grid in order to plan the best surgical procedure which would allow maintaining a minimal length of small intestine needed to yield a satisfying quality of life and nutritional status. the secondary objective of this study is to evaluate the reproducibility of the standardized scanner's reading grid.


Eligibility criteria:
inclusion criteria: * patients with small intestine neuro-endocrine tumors (net) operated in the digestive surgical service of the university edouard herriot hospital of lyon (pr. gilles poncet) between the 1st of january 2014 and the 31st of march 2019, * having done a preoperative thoraco-abdomino-pelvic scanner with arterial and portal sequences. * scanner imaging, operative report and anatomo-pathological report available exclusion criteria: * no computerized tomography (ct) images available

Keywords: intestinal tumors computerized tomography
auricular acupuncture for primary insomnia

Conditions: Primary Insomnia

Summary: this double-blind rct will evaluate the therapeutic effectiveness and safety of auricular acupuncture(aa) for primary insomnia(pi) .

investigators will conduct a 2-year clinical trial on auricular acupuncture (aa) for primary insomnia (pi), which is a double-blind (patient-blind and assessor-blind) rct. 288 patients will be randomly assigned into 2 groups: the treatment group (group a) and the control group (group b). group a will be treated with aa plus oral eszopiclone, while group b will be treated with sham aa plus oral eszopiclone. all patients will receive a continuous 4-week treatment and 28-week follow-up. the data will be analyzed by the third party who is not clear about allocation and treatment.

Eligibility criteria:
inclusion criteria: * meet the diagnosis of pi according to dsm-5; * aged 18-64 (including 18 and 64); * provided a signed written consent form. exclusion criteria: * the patient has somatic disease like severe respiratory, circulatory, endocrine system disease and hepatic/renal insufficiency; * the patient suffers from moderate / major depression (bdi score ≧ 8 points), moderate / severe anxiety disorder (sas score ≧ 61 points) or any other serious mental disease; * the patient who abuse drug alcohol or substance; * the patient suffers from dementia or any other severe cognitive impairment; * the patient is in pregnancy or lactation period; * patient who is a night worker or stick to irregular sleep pattern, and can't or don't want to terminate this kind of work mode; * the patient has history of suicide or suicidal tendency; * the patient is allergic to eszopiclone or any other sedative-hypnotic drugs; * the patient who has taken psychiatric, hypnotic or antihistamine drugs during the last 4 weeks before baseline, however, the patient who use the prescription or nonprescription hypnotic drugs no more than twice a week can be recruited as soon as drug withdrawal; * the patient who is receiving ongoing psychological treatment; * the patient who has obstructive sleep apnea, restless leg syndrome, sleep rhythm disorders, parasomnias, etc.

Keywords: primary insomnia auricular acupuncture
levels of neuregulin-4 and its receptor erbb4 in periodontitis patients with and without diabetes type 2

Conditions: Periodontitis; Diabetes Mellitus

Summary: the aim of this study is to assess the levels of neuregulin-4 and its receptor erbb4 in the gcf and saliva in stage iii and iv periodontitis patients with and without type 2 diabetes mellitus.

the aim of this study is to measure the levels of nrg4 and erbb4 in the gcf and saliva of periodontitis stage iii and iv patients with and without type 2 diabetes mellitus and to correlate their levels with the periodontal clinical parameters and the blood glucose levels including the fasting plasma glucose level (fpg) and glycated hemoglobin (hba1c). this study will be conducted in the oral medicine and periodontology department, faculty of dentistry- cairo university, egypt. patients will be selected from the outpatient clinic of the department of oral medicine and periodontology, faculty of dentistry-cairo university.

Eligibility criteria:
inclusion criteria: * for periodontitis stage iii and iv patients according to (papapanou et al., 2018 and tonetti et al., 2018) 1. bleeding on probing (bop) ≥ 30%. 2. at least four non-adjacent teeth sites in each jaw having cal ≥ 5 mm and pd ≥ 6 mm in one or more sites. 3. tooth loss due to periodontitis ≥ 5 teeth. 4. presence of a minimum of 15 natural teeth. for diabetes and non-diabetic patients according to ("diagnosis and classification of diabetes mellitus," 2014) 5. patients with type 2 diabetes mellitus will be diagnosed as having type 2 diabetes mellitus ≥ 5 years before the study and treated with stable doses of oral hypoglycaemic agents and/or insulin under the supervision of an endocrinologist with their glycated haemoglobin level (hba1c) \> 6%. 6. non diabetic patients in the control and stage iii and iv periodontitis groups will be selected as having fasting plasma glucose (fpg) \<126 mg/dl. exclusion criteria: 1. individuals with any known systemic disease other than type 2 diabetes. 2. pregnant and lactating women. 3. individuals that received periodontal treatment within the last 6 months. 4. individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months. 5. former or current smokers.
nitrite, isoquercetin and endothelial dysfunction (nice) trial

Conditions: Chronic Kidney Disease

Summary: the proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease.

the proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease. investigators will recruit 70 albuminuric ckd patients and randomly assign participants to combination therapy with sodium nitrite and isoquercetin or placebo for three months.

Eligibility criteria:
inclusion criteria: * men and women aged 21-74 years old with any race/ethnicity background * ckd as defined by an egfr \<60 ml/min/1.73 m2 or urinary albumin to creatinine ratio ≥ 30 mg/g or protein to creatinine ratio ≥150 mg/g. * systolic bp≥120 and \<180 mmhg and/or diastolic bp≥70 and \<110 mmhg exclusion criteria: * allergic to organic nitrite, isoquercetin, niacin, or vitamin c * institutionalized (e.g., prisoner, nursing home or skilled nursing facility resident) * unable or unwilling to give consent * known hiv infection and/or aids * pregnant or lactating women * currently on dialysis * previous or current organ or bone marrow transplant * receiving immunosuppressive treatment or other immunotherapy * receiving chemotherapy or alkylating agents for systemic cancer * recent acute myocardial infarction, cerebrovascular accidence or transient ischemic attack, or hospitalization in 3 months * acute kidney injury within the previous 3 months * currently taking a phosphodiesterase-5 enzyme inhibitor, such as viagra * history of chronic headaches * chronically receiving fluoroguinolones, cyclosporin (neural, sandimmune), nitrate drug, nsaids ( except aspirin ≤ 81 mg daily), allopurinol or uloric, meperidine and related central nervous system (cns) depressants, oral glucocorticoids, and not willing or able to stop during study period. * active infection (i.e. systemic or osteomyelitis) * class iii or iv heart failure * history of hemolytic anemia including sickle cell disease * hemoglobin \<10 * history of chronic obstructive pulmonary disease (copd) * have a positive screen for glucose-6-phosphate dehydrogenase (g6pd) deficiency at screening * involvement in other clinical trials * current alcohol or other substance abuse * current smokers * unwillingness to stop flavonoid supplementation * unwillingness to stop nitrate and/or nitrite supplementation

Keywords: endothelial dysfunction inflammation oxidative stress egfr urine albumin
individual vs. group hypnotherapy in patients with irritable bowel syndrome

Conditions: IBS - Irritable Bowel Syndrome

Summary: patients' fulfilling rome iii criteria for ibs with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. the patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy. the treatment consists of eight sessions of gut directed hypno therapy during twelve weeks. effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment.

patients' fulfilling rome iii criteria for ibs with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. firstly, the patients are invited to a meeting with the nurse for information about the study, check for eligibility and to sign the written informed consent. exclusion criteria that could influence gi symptoms such as organic gi disease, severe psychiatric comorbidity and pregnancy are controlled for. the patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy and cognitive behavioral therapy. the randomization is organized and performed in blocks by an external unit connected to the university in order to be accurate. the treatment consists of eight sessions of gut directed hypnotherapy during twelve weeks. a standardized protocol is used and is the same both in the group setting as well as in the individual treatment arm. in each group approximately eight patients are included. every session lasts for one hour. outcome measures in the study are gi symptom severity, gi-specific anxiety, psychological distress and health related quality of life. these effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment and during the 6 months-, 1 and 2 year follow-up.

Eligibility criteria:
inclusion criteria: * ibs according to rome iii criteria exclusion criteria: * organic gi disease
omegia softgel clinical research program

Conditions: Skin Manifestations; Antioxidative Stress; Eye Strain; Vaginal Disease

Summary: evaluate the improvement of regulation of skin and blood index composition after consumption of omegia® softgel

the blood biochemical analysis at weeks 0 and 12, including catalase, tumor necrosis factor-α, cholesterol, triglyceride, high-density lipoprotein-cholesterol and low-density lipoprotein- cholesterol. the skin assessment at weeks 0, 4 and 12, including skin brightness, skin redness sensitivity index, skin moisture, skin elasticity, facial skin pores, facial skin texture and skin collagen content.

Eligibility criteria:
inclusion criteria: ● female subjects older than 45 years exclusion criteria: * involuntary subjects * skin disease, liver cirrhosis or chronic renal failure * those with known cosmetic, drug or food allergies * pregnant women and nursing mothers. * those taking chronic disease medication * the subject has received laser facial treatment, fruit acid facial peeling, long-term sunlight, etc. within four weeks of the test
hematocrit effect on a blood glucose monitor

Conditions: Diabetes Mellitus

Summary: this study assesses the repeatability precision of a blood glucose monitoring system pursuant to iso 15197

this study assesses the repeatability precision the blood glucose monitoring systems for personal use tj100 pursuant to iso 15197:2015 guidelines

Eligibility criteria:
inclusion criteria: * male or female patients with clinical indication for blood glucose testing * signed form of consent * minimum age of 18 years * subjects are legally competent and capable to understand character, meaning and consequences of the study exclusion criteria: * pregnancy or lactation * severe acute disease (at study physician's discretion) * acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion) * current constitution that does not allow participating in the study (e.g. hematocrit out of * the devices's specifications, medication known to influence blood glucose measurements; appendix a of iso 15197) * being unable to give informed consent * age younger than 18 years * legally incompetent