Kornimate/medical-research-clean huggingface dataset:
evaluating ha 0.15% compared with cyclosporine 0.05%, and efficacy of combination therapy in dry eye disease patients

Conditions: Dry Eye; Dry Eye Syndromes

Summary: in patients with moderate to severe dry eye syndrome, the test drug (ha 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. the study objective is to demonstrate that the test drug is not clinically inferior to the control drug. furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.


Eligibility criteria:
inclusion criteria: * male or female, age 20 or over * moderate to severe dry eye disease patients * written informed consent to participate in the trial exclusion criteria: * any laser or ocular surgery within 2 months prior screening * use of contact lenses * any condition limiting patient's ability to participate in the trial
safety of intravenous lacosamide dose followed by twice daily oral lacosamide in subjects with partial-onset seizures

Conditions: Partial Epilepsies; Partial Onset Seizures

Summary: the purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.

this multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subjects 16 - 60 years of age with partial-onset seizures. three consecutive 25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400 mg) administered as a single 15-minute intravenous (iv) loading dose followed by the equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose 12 hours after the iv dose. a fourth cohort of 25 subjects repeated the 300 mg dose to provide safety data on a total of 50 subjects at the highest well-tolerated dose.

Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy with simple partial seizures and/or complex partial seizures * stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (aed(s)) for 28 days prior to screening and duration of trial * acceptable candidate for venipuncture and intravenous (iv) infusion * at least 1 partial seizure with motor component per 90 days * maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type exclusion criteria: * previous use of lacosamide * history of primary generalized seizures * history of status epilepticus within last 12 months * history of cluster seizures during 8 week period prior to screening * non-epileptic events, including psychogenic seizures that could be confused with seizures * use of neuroleptics, monoamine oxidase (mao) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening * received any rescue benzodiazepines more than once during the 28 days prior to screening * concomitant treatment of felbamate or previous felbamate therapy within last 6 months * prior or concomitant vigabatrin use

Keywords: epilepsy seizures lacosamide vimpat intravenous
comparison of two nn5401 formulations versus biphasic insulin aspart 30, all in combination with metformin in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to compare two nn5401 (soluble insulin analogue combination \[siac\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject.) * insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months) * treatment with one or two oral anti-diabetic drugs (oads): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (spc) * hba1c, 7.0-11.0 % (both inclusive) * body mass index (bmi), 25.0-37.0 kg/m\^2 (both inclusive) exclusion criteria: * metformin contraindication according to local practice * thiazolidinedione (tzd) treatment within previous 3 months prior to visit 1 * any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation * subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
direct and indirect benefits of influenza vaccine versus placebo in healthy children

Conditions: Influenza Virus Infection

Summary: while immunisation of school-age children against influenza is not recommended in hong kong, past experience in japan and elsewhere suggests that immunisation of children may protect the wider community through its indirect transmission-limiting impact as well as the direct immunologic protection afforded vaccinated children themselves. we aim to assess whether vaccinating children against influenza protects vaccinees as well as their household contacts from infection.

design and subjects: a double-blind randomised controlled trial of 800 subjects aged 6-17 drawn from the general population and their 2000 household contacts. the subjects will be randomised in a 3:2 ratio to the intervention and placebo groups, respectively. serum samples will be collected from subjects pre- and 1 month post-vaccination, and after the influenza season. serum samples will be collected from household contacts at baseline and at the end of the influenza season. during the follow-up period, subjects and household members will keep symptom diaries and those reporting influenza-like-illness will be offered free doctor consultations or home visits where we will arrange for collection of nose and throat swabs. study instruments: an antibody titre of ≥40 in the post-vaccine serum will be used to define seroprotection to those particular strains, while a four-fold or higher increase in antibody titres between baseline and end-of-season follow-up of the household contacts will define influenza infection during the season. subjects and household contacts will be asked to keep symptom diaries, and during episodes of ili we will collect nose and throat swabs for laboratory confirmation of influenza infection; the primary serology results will then be compared with clinical and laboratory-confirmed influenza episodes. interventions: 1 (intervention) inactivated influenza vaccine (vaxigrip, sanofi pasteur); 2 (placebo) saline injection. main outcome measures: the proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms. analysis: intention to treat, adjusting for within-household correlation in influenza attack rates.

Eligibility criteria:
inclusion criteria: * all vaccinees must be hong kong residents aged between 6 and 17. exclusion criteria: * vaccinees should not be allergic or hypersensitive to the active substances or components (eggs, chicken proteins, formaldehyde, neomycin, etc.) used in the vaccines or where vaccination is otherwise contraindicated. subjects should not have an underlying immunocompromised condition or be receiving immunosuppressive agents.

Keywords: influenza vaccination children influenza-like illness
a study on diagnosis and treatment of end stage liver disease complicated with infection (sesldir study)

Conditions: End Stage Liver Disease; Infection

Summary: the term of end stage of liver disease (esld) was raised in 80's of 20 century, but without a restrict definition. infections are the cause and effect in occurrence and development of esld, which not only induce or exacerbate esld, but also are the most combined complication. multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting treatment, disorder of intestine microbiota, et al are dilemma in clinical practice. appropriate and formal diagnosis and treatment of esld combined infection are imperious nowadays.


Eligibility criteria:
inclusion criteria: decompensation of liver cirrhosis: 1. alb \<35 g / l; a / g \<1.0 2. tbil\> 35μmol / l; 3. alt\> 1 × uln and / or ast\> 1 × uln 4. pta \<60% 5. ascites or hepatic encephalopathy or esophageal variceal bleeding acute-on-chronic liver failure: 1. chronic liver disease based on: chronic hepatitis or decompensated cirrhosis 2. onset time: \<4 weeks 3. hepatic encephalopathy: with or without 4. coagulation: pta ≤ 40% or inr ≥ 1.5 5. jaundice: tbil ≥ 171μmol / l or daily increase ≥ 17.1μmol / l chronic liver failure: 1. the basis of chronic liver disease: decompensated cirrhosis 2. onset time: - 3. hepatic encephalopathy: with or without 4. coagulation: pta ≤ 40% or inr ≥ 1.5 jaundice: significantly higher exclusion criteria: -
confocal laser endomicroscopy as an imaging biomarker for the diagnosis of pancreatic cystic lesions

Conditions: Pancreatic Cyst

Summary: the study schema is shown in figure 4. (a) all patients referred to one of the participating academic centers for eus evaluation of the pcl will be enrolled in the protocol if they satisfy inclusion criteria. patient consent will be obtained during the clinic visit or prior to their eus. eus-guided ncle imaging is first performed (b) followed by eus-guided fna and aspiration of cyst fluid. the cyst fluid is analyzed for cea and cytology. as per institutional standard of care, the cyst fluid is also sent for molecular analysis. the results of the cyst fluid molecular analysis (b) will be utilized for the most likely diagnosis. based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (c). surgical histopathology serves as "gold standard" for diagnosis. it is anticipated that the majority of patients will undergo surgical resection after their eus.


Eligibility criteria:
inclusion criteria: * patient age 18 years or older * all patients referred for eus-fna of accessible pcl where surgery is contemplated * minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies exclusion criteria: * unable to obtain informed consent * unable to tolerate the procedure * women with known pregnancy at time of procedure * patient age less than 18 years * bleeding diathesis * known allergy to fluorescein * prior pancreatic cancer * prior pancreatic surgery

Keywords: confocal laser endomicroscopy pancreatic cancer ipmn
activity at ventilation threshold on appetite and food intake in boys

Conditions: Obesity Prevention

Summary: the investigators hypothesize exercise increases short term appetite and food intake, and interferes with satiety and satiations to a preload in normal weight, overweight and obese boys.

the effect of exercise (exr) on short-term food intake (fi) and subjective appetite was investigated in normal weight (nw), overweight (ow) and obese (ob) boys were randomized into 4 treatments. each boy consumed either a non-caloric sweetened control (con) or glu drink after either exercise (exr) or sedentary activity. subjects exercised at their ventilation threshold (vet).

Eligibility criteria:
inclusion criteria: * healthy boys with no emotional, behavioral or learning problems exclusion criteria: * girls

Keywords: boys obesity physical activity exercise
towards understanding the phenotype of cardiovascular disease in ckd - true-type-ckd study

Conditions: Heart Failure; Cardiomyopathies; Chronic Kidney Diseases; Hypertrophy, Left Ventricular

Summary: premature cardiovascular disease (cvd) is the leading cause of death in patients with kidney disease (ckd). excessive cardiac mortality is thought to be secondary to non-atherosclerotic processes, with left ventricular (lv) hypertrophy (lvh) and remodelling being the predominant phenotypical features. along with other risk factors, subclinical ischaemia and haemodynamic perturbations associated with haemodialysis (hd) are thought to contribute to the ultimate development of lv systolic and diastolic dysfunction. the development of these adverse features reflects a specific cardiomyopathy due to ckd and subsequently, to uraemia. patients receiving hemodialysis (hd) have a higher incidence rate of heart failure (predominantly with preserved ejection fraction), with phenotypically eccentric hypertrophic remodelling, systolic and diastolic dysfunction as well as high rate of interstitial myocardial fibrosis. detection and ultimately reversal of the development of this ckd-related cardiomyopathy are important goals for improving the cvd, morbidity and mortality of ckd patients.the objectives of this study are, firstly, to investigate the complex myocardial phenotype in patients with various stages of ckd, secondly, to relate the cmr-measures to outcome, and thirdly, to be able to estimate the effects of chronic uremia/hypervolemia. deciphering the predominant driver of remodelling on an individual level may help to personalise anti-remodelling strategies. native t1 and t2 mapping imaging provide non-invasive imaging tools to detect myocardial fibrosis and oedema, respectively. prognostic associations of these measures may clarify the relative prevalence of adverse phenotype and their relative contribution to adverse events and poor outcome. the role of chronic water retention and uraemia may be associated with interstitial myocardial oedema promoting further the remodelling process.


Eligibility criteria:
inclusion criteria: 1. adults \>18 years of age 2. able to provide informed consent 3. chronic kidney disease stages g3-5 (egfr\<59 ml/min/1.73m2) exclusion criteria: 1. absence of absolute clinical indication for mri studies (mr unsafe or incompatible devices, aneurysm clips, cochlear implants, loose metal foreign objects) 2. absolute contraindications to gadolinium contrast agent (previous allergic reaction or pregnancy),
smart integrated health promotion program

Conditions: Quality of Life

Summary: health promotion behavior is important in older adults.the purpose of this study is to examine the efficacy of smart integrated health promotion intervention among middle age adults and older adults in community.

there very limited research focused on leisure activity, nutrition status, quality of life and subjective well-being. in addition, there is lack of research develop smart integrated health promotion intervention to enhance well-being for middle age adults older adults in community and examine the efficacy of the intervention. the purpose of this study is to examine the efficacy of smart integrated health promotion intervention among middle age adults and older adults in community .

Eligibility criteria:
inclusion criteria: (1) age over 50 years exclusion criteria: 1. those who could not understanding protocol or communication with search nurses; 2. or with cognitive impairment or mental disorders; 3. or advance cancer; 4. or have been myocardial infarction; 5. or congestive heart failure was excluded.

Keywords: leisure activity nutrition status quality of life subjective well-being older adults
protocol of reintroduction of beta-lactams in children at low risk of anaphylaxis.

Conditions: Hypersensitivity; Beta Lactam Adverse Reaction

Summary: the purpose of this study is to establish the rationale for the practice of performing an oral reintroduction test without previous skin tests in children at low risk of ige-mediated reaction or drug-induced toxidermia, and to confirm the criteria for a drug reintroduction test could be performed without previous skin tests, without subsequent risk of reaction for the child. the primary endpoint will be the risk of a severe ige-mediated or delayed hypersensitivity reaction in children who received beta-lactam drug reintroduction protocol prior to skin testing.


Eligibility criteria:
inclusion criteria: * children under 16 years of age coming for a consultation for a beta-lactam oral reintroduction test. exclusion criteria: * refusal of the legal representatives of the subject for their child to participate in the study, * if his age permits, refusal of the subject to participate in the study, * subject aged over 16, * pregnancy, * absence of affiliation of the subject to a social security scheme, * skin tests with incriminated beta-lactam already made before the consultation, * existence of contraindications to the realization of oral reintroduction drug test with the suspected antibiotic, * existence of criteria in the initial reaction suggestive of a non-low risk of ige-mediated or delayed hypersensitivity to the incriminated beta-lactam, taking antihistamine, corticosteroids or beta-blockers within 5 days prior to the oral reintroduction drug test, * travel abroad of the child scheduled within 7 days of the oral reintroduction drug test.

Keywords: hypersensitivity beta lactam adverse reaction
an exploratory study of rebamipide in patients with active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (asa).


Eligibility criteria:
inclusion criteria: 1. patients with active ulcerative colitis 2. patients having an insufficient response to asa oral formulation: (1) patients whose ongoing use of asa oral formulation from ≥2 weeks prior to the day before registration is fixed at mesalazine ≥2 g/day or salazosulfapyridine 3-6 g/day, (2) patients with continuous bloody stools from ≥2 weeks prior to the day before registration, (3) patients whose dai subscores are ≥2 points for "bloody stools" and ≥2 points for "endoscopic findings" 3. patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure) 4. outpatients exclusion criteria: 1. patients who have a history of intestinal resection (other than appendiceal resection) 2. patients who have a complication of malignant tumor 3. female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period 4. patients who have complications of serious cardiac, hepatic or renal impairment

Keywords: rebamipide enema ulcerative colitis
sars cov-2 infection and inflammatory biomarkers

Conditions: COVID-19; Inflammation

Summary: early research suggests that inflammation plays a key role in the development of sars cov-2 infection. the immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. this study ought to investigate the association of simple biomarkers such as nlr and plr with the clinical outcome in sars cov-2 infection patients.

early research suggests that inflammation plays a key role in the development of sars cov-2 infection. the immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. moreover, previous studies have demonstrated that a sustained release of anti-inflammatory cytokines may lead to high levels of circulating neutrophils and lymphocytes' apoptosis with subsequent lymphopenia and immune response imbalance. therefore, circulating biomarkers that represent inflammation and immune status could serve as potential predictors for the prognosis of sars cov-2 patients. the neutrophil to lymphocyte ratio (nlr) and platelet to lymphocyte ratio (plr) are cheap and simply calculated biomarkers which have been identified as markers of systemic inflammation, severity of the disease and prognosis in several patient populations. this study ought to investigate the association of simple biomarkers such as nlr and plr with the clinical outcome in sars cov-2 infection patients.

Eligibility criteria:
inclusion criteria: * consecutive patients with polymerase chain reaction (pcr) confirmed sars cov-2 infection exclusion criteria: * patients aged\<18 years

Keywords: covid-19 biomarkers inflammation
a phase 3 study to compare the efficacy and safety of co-administered hgp0608, hgp0904 and hcp1306 versus hcp1701 in patients with hypertension and dyslipidemia

Conditions: Hypertension; Dyslipidemias

Summary: a randomized, double-blinded, multi-center, phase iii study to compare the efficacy and safety of co-administered hgp0608, hgp0904 and hcp1306 versus hcp1701 in patients with hypertension and dyslipidemia


Eligibility criteria:
inclusion criteria: * age ≥ 19 * patients who understood the contents and purpose of this trial and signed informed consent form * patients with essential hypertension and dyslipidemia exclusion criteria: * patients with differences between arms greater than 20 mmhg for mean sitsbp or 10 mmhg for mean sitdbp * patients with mean sitsbp ≥ 180 mmhg or mean sitdbp ≥ 110 mmhg * concomitant administration of cyclosporine * tolerance or hypersensitivity angiotensin ii receptor blocker or hmg-coa reductase inhibitor, calcium channel blocker(dihydropyridine) or multi-drug allergy * hereditary angioedema or medical history of angioedema in the treatment of ace inhibitors or angiotensin ii receptor blockers * fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin * cpk normal range \> 2 times * secondary hypertension and suspected secondary hypertension * orthostatic hypotension with symptoms * uncontrolled primary hypothyroidism(tsh normal range ≥ 1.5 times) * severe hepatopathy or active hepatopathy (ast or alt normal range ≥ 3 times) * active gout or hyperuricemia(uric acid ≥ 9mg/dl) * iddm or uncontrolled type 2 diabetes mellitus (hba1c \> 9%) * ventricular arrhythmia * medical history * severe heart disease(heart failure of nyha class iii-iv) * severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(tia) * hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve * ischemic heart disease(myocardial infarction, angina) within 6months * angioplasty or coronary artery bypass graft(cabg) surgery within 6months