Kornimate/medical-research-clean huggingface dataset:
rivet pvs therapy in group 2 ph-hfpef

Conditions: Heart Failure; Pulmonary Hypertension

Summary: this clinical investigation is a prospective, multicenter, non-randomized, open-label, early feasibility study to evaluate the safety, performance, and initial clinical efficacy of the rivet pvs therapy in patients with symptomatic pulmonary hypertension.


Eligibility criteria:
select inclusion criteria: * age ≥ 18 years * prior diagnosis of group 2 ph due to hfpef, with the following resting hemodynamic criteria confirmed in the past year by right heart catheterization a. mpap ≥ 25 mmhg at rest or mpap/co slope \> 3 mmhg/l/min during incremental exercise * confirmation of the following hemodynamic criteria during supine exercise a. pcwp ≥ 25 mmhg, or pcwp/co slope \> 2 mmhg/l/min * chronic symptomatic heart failure documented by the following: 1. nyha hf class ii with history \> ii, or class iii, or ambulatory class iv 2. ≥ 1 hf hospitalization, or healthcare facility with iv diuretics or intensification of oral diuresis for hf within 12 months, or nt-pro bnp value \> 400 pg/ml in normal sinus rhythm or \> 750 pg/ml in atrial fibrillation in past 6 months * ongoing stable guideline directed medical therapy (gdmt) for hf and medically optimized per treating hf physician according to current accf/aha guidelines that is expected to be maintained without change for 6 months (excluding diuretic dosage changes for hf optimization within 90 days of the index procedure) * 6mwd ≥ 150 m select exclusion criteria: * any therapeutic intracardiac intervention within the last 30 days * ph group 1, 3, 4 or 5 * mean rap \>12 mmhg by rhc at rest on room air * right ventricular dysfunction, defined as one or more of the following 1. greater than moderate rv dysfunction as assessed by tte and/or mri 2. rv fac \< 35% 3. tapse \< 14 mm via tte 4. rv size severely enlarged compared to lv size as estimated by tte and/or mri * severe tricuspid valve regurgitation * peak systolic pulmonary arterial pressure \> 80 mmhg by rhc at rest while awake * mean pulmonary arterial pressure \> 50 mmhg by rhc at rest while awake * pvr \> 6 wood units at rest while awake on room air or exercise pvr \> 2 wood units * left ventricular ejection fraction \< 50% * severe heart failure, defined as one or more of the following: 1. acc/aha/esc stage d heart failure, non-ambulatory nyha class iv hf 2. if bmi \< 30, cardiac index \< 2.0 l/min/m2 3. if bmi ≥ 30, cardiac index \< 1.8 l/min/m2 4. requires continuous intravenous inotropic infusion 5. requires mechanical circulatory support 6. currently on the cardiac transplant waiting list * chronic renal dysfunction defined as one or more of the following: 1. currently requiring dialysis; or 2. egfr \< 35 ml/min/1.73 m2 by the ckd-epi equation * chronic pulmonary disease defined as one or more of the following: 1. requires continuous home oxygen therapy 2. recent hospitalization for exacerbation within 12 months prior to screening 3. fev1 \< 50% predicted
comparison of 1 month vs. 12 months dapt in patients undergoing pci with genoss® des

Conditions: Coronary Artery Disease

Summary: this study is a prospective, open-label, multicenter, randomized clinical trial to evaluate the efficacy of 1 month dual antiplatelet therapy (dapt) with aspirin plus clopidogrel followed by clopidogrel monotherapy, compared with 12 months dapt with aspirin plus clopidogrel in patients undergoing percutaneous coronary intervention with genoss® drug eluting stents.

dual antiplatelet therapy (dapt) with aspirin and a p2y12 inhibitor is recommended following percutaneous coronary intervention (pci). however, the optimal duration of dapt is still controversial, and current us and european guidelines recommend 12+ months for acute coronary syndrome (acs) and 6+ months in chronic coronary syndrome (ccs). a meta-analysis comparing short (6 months) and long-term (12 months) dapt has shown a lower risk of bleeding with no significant increase in ischemia risk associated with short dapt use. monotherapy with a p2y12 inhibitor clopidogrel has been proposed as a novel alternative to dapt in patients with atherosclerotic cardiovascular disease. clopidogrel has shown comparable bleeding events after pci compared to aspirin, and reduced the risk of subsequent ischemic events. in addition, several trials have reported that clopidogrel monotherapy now has a lower risk of bleeding than antiplatelet drug therapy (dapt). these results suggest that p2y12 inhibitor monotherapy has a lower risk of bleeding in patients with pci and can be compared with dapt in preventing recurrent ischemic events. given that genoss® drug-eluting stent (des) has a very low incidence of stent thrombosis (st), short-term dapt after pci is now expected to reduce the risk of bleeding with clopidogrel instead of aspirin, without increasing cardiovascular events.

Eligibility criteria:
inclusion criteria: * subjects must be at least 19 years of age * subjects undergoing elective pci with genoss® drug eluting stents * subject who can understand the risk, benefit and treatment alternatives, and when he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure exclusion criteria: * subjects presenting with acute myocardial infarction * subjects with less than 1 year of life expectancy * subjects presenting with cardiogenic shock * subjects requiring anticoagulation (warfarin, direct oral anticoagulant), or those requiring antiplatelet agents other than aspirin and p2y12 inhibitors. * subjects with history of intracranial hemorrhage (ich) * known hypersensitivity or contraindications to study medications (aspirin, clopidogrel), or drugs used in the procedure (heparin, contrast media, sirolimus). those with contrast hypersensitivity can be enrolled if symptom/signs can be controlled by anti-histamines or steroids.

Keywords: percutaneous coronary intervention dual antiplatelet therapy drug eluting stent
registry of iga nephropathy in chinese children

Conditions: IgA Nephropathy; Proteinuria in Nephrotic Range; Immunosuppressive Treatment

Summary: this study tries to identify the safe and effective treatment option for iga nephropathy in children. investigators will perform prospective registration study among 25 pediatric nephrology medical centers in china.

a total of 1200 patients diagnosed as primary iga nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide, according to the following protocol. 1. establishment of registration database online. 2. participants will be enrolled according to the inclusion criteria and exclusion criteria. 3. the following data will be collected prospectively, including demographic data, clinical symptoms, physical examination, laboratory examination, renal pathology, treatment protocol and follow-up. 4. spss software (version 14.0; spss, inc., chicago, il, usa) will be used for statistical analysis. p value less than 0.05 will be considered significant.

Eligibility criteria:
in-patients will be enrolled with the following criteria. inclusion criteria: * clinical diagnosis of primary iga nephropathy. * presenting with nephrotic proteinuria, defined as 24-hour urinary protein\>50mg/kg, or upc\>2.0 mg/mg. * informed consent must be signed. exclusion criteria: * diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis, hepatitis b virus associated nephritis, etc.
spectrum of epididymis and vas deferens anomalies among children with cryptorchidism

Conditions: Epididymal Cyst; Vas Deferens; Anomaly

Summary: : data was collected retrospectively from six centers providing care for patients with undescended testicles from september 2017 to february 2019. all patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where photographs of the anomalies were taken were included.

background: epididymal and vas deferens anomalies are not rare among children with cryptorchidism. they may affect fertility following orchiopexy. material and methods: data was collected retrospectively from six centers providing care for patients with undescended testicles from september 2017 to february 2019. all patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where photographs of the anomalies were taken were included.

Eligibility criteria:
inclusion criteria: - all included cases had photographic documentation. exclusion criteria: * cases without photographic documentation.

Keywords: epididymal cyst duplicated vas deferens. curled vas deferens vanished testis
the role of genetic mutations and of circulating mrnas in uveal melanoma

Conditions: Uveal Melanoma

Summary: the aim of the study is to identify genetic and epigenetic biomarkers in uveal melanoma, and to evaluate their diagnostic and prognostic role. in particular, the specific objectives are: 1. to identify the circulating somatic mutations associated with uveal melanoma; 2. to identify the de-regulated mirnas associated with uveal melanoma; 3. to evaluate the diagnostic and prognostic role of the identified genetic and epigenetic markers; 4. to identify possible therapeutic targets.

this is a prospective, multicentric, case-control study, aimed at studying the gene and epigenetic mechanisms involved in uveal melanoma. patients with uveal melanoma, will be enrolled. for each subject included in the study, in a blood sample will be searched the mutations of the gna11 and gnaq genes and the expression of the following micrornas: mir - 506-514 cluster, hsamir - 592 and hsa - mir - 199a - 5p; the digital pcr droplet system will be used. the study will not change the diagnostic-therapeutic process adopted in the clinical practice and will have no influence on the clinical management of enrolled patients. a group of age sex matched controls will be recruited among patients scheduled for cataract surgery. the sample size was calculated to detect, with a power of 80% and a confidence interval of 95%, a difference of 13.5% between the incidence of mutation of the gna11 gene in patients with melanoma and healthy controls. (13.5% vs 0%). overall, at least 51 patients with uveal melanoma and 51 controls will be recruited, for a total of at least 102 subjects.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with uveal melanoma * both sexes * age ≥ 18 years exclusion criteria: * a) autoimmune diseases * b) tumors * c) kidney diseases * d) atherosclerosis * e) subjects undergoing anti-inflammatory therapies.

Keywords: uveal melanoma gna11 mutation gnaq mutation micro rna
central venous catheter colonisation among critically ill patients in intensive care units

Conditions: Sepsis; Septic Shock; Post-cardiac Surgery; Post-Cardiorespiratory Arrest Coma; Head Injury; Hypoxic Brain Damage; Acute Liver Failure; Diabetic Ketoacidotic Hyperglycaemic Coma

Summary: background: central venous catheter insertion technique and indwelling time are major risk factors for cvc colonisation. colonisation occurs through microbial migration and biofilm formation along the catheter insertion tract. this study set out to determine the prevalence and associated factors for central venous catheter colonisation among critically ill patient. no data exists in this clinical setting addressing this topic. methods: the study population included 100 participants with central venous catheters in situ for at least 24 hours. catheter tip (distal 5-cm segment) and blood cultures (10mls peripheral blood) were obtained at the time of catheter removal.

introduction : central venous catheter (cvc) insertion technique and time spent in situ (dwell period) are major risk factors for cvc colonisation among patients admitted to intensive care units (icu) worldwide. normal skin flora colonizes cvcs early in their dwell period (\< 7-10 days) causing variable occurrence of infections in all categories of patients. uganda has no data on cvc colonisation and with increasing use there is concern of cvc colonisation and its consequences. this study was done to determine the prevalence and associated factors of cvc colonization among patients in general icus. methodology: this was prospective cohort study. critically ill patients with cvcs in situ from four general icus were consecutively enrolled into the study. data on socio-demographic, clinical characteristics (diagnosis, comorbidities) and cvc insertion (site, technique, experience) was collected using a standardised questionnaire until a sample size of 100 was achieved. at the time of cvc removal, the cvc tip (distal 5cm segment) was aseptically obtained and cultured for microorganisms using the semi-quantitative method. a blood culture sample (10mls) was also collected from a peripheral site at the same time. data was double entered into epidata version 3.1.5 and exported to stata version 12.0 for analysis.

Eligibility criteria:
inclusion criteria: * patients of all age groups were included in this study * all critically ill patients admitted to the icu with central venous catheters in situ * written informed consent/assent * waiver of consent for unconscious patients with no attendant/valid surrogate respondent to provide the required information exclusion criteria: •patients who were already on treatment for cvc-related infectious complications.
reducing beverages and sugar and increasing physical activity in public school adolescents from brazil

Conditions: Sugar Intake; Beverage Intake; Fruit Intake; Beans Intake; Physical Activity

Summary: the main objective is to evaluate the effect on bmi of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.

specific objectives are: 1. to compare total, lean, and fatty body mass variation in adolescents aged 11 to 14, from 7th and 8th grades from schools under intervention and from the ones not subjected to the intervention program. 2. to compare sweetened beverages consumption and sugar intake before and after the intervention in both groups of schools. 3. to evaluate the impact of the intervention on the selling of sweetened beverages in the cafeterias. 4. to compare change in family expenditures with sweetened beverages and sugar.

Eligibility criteria:
inclusion criteria: * 5th grades exclusion criteria: * pregnancy

Keywords: school children body mass index sugar intake beverage intake
a clinical trial to evaluate the efficacy and safety of ckd-391 and ckd-331 in patients with primary hypercholesterolemia

Conditions: Primary Hypercholesterolemia

Summary: this is a randomized, double-blind, multi-center, therapeutic confirmatory, phase 3 trial to evaluate the efficacy and safety of ckd-391 and ckd-331 in patients with primary hypercholesterolemia

participants were randomly assigned in a 1:1:1:1 ratio to the following groups: combination therapy of d377 and ckd-331, d377, ckd-331, and d086. the patients are prescribed oral administration of the appropriate ip daily (3 tablets: actual medication and placebo) for 8 weeks.

Eligibility criteria:
inclusion criteria: * adults ≥ 19 years of age * primary hypercholesterolemia * patients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigator exclusion criteria: * secondary hypercholesterolemia * conditions / situations such as: 1. presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels 2. severe renal impairment or active liver disease * history of hypersensitivity or allergies to investigational drugs or drug of similar chemical classes. * history of drug abuse or alcoholism within 24 weeks before screening * any surgical or medical condition which might significantly affect the absorption, distribution, metabolism, or excretion of investigational drugs * patients who have been taken with other investigational drugs within 8 weeks before screening
correlation study of lipid metabolites as markers of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: as one of the common malignant tumors in china, primary liver cancer, whose incidence rate and mortality rate are always in the top five, is seriously threatening the health of people. therefore, early diagnosis and treatment of primary liver cancer are of great significance. in recent years, the incidence of primary liver cancer, which is caused by hepatic steatosis or metabolic dysfunction-related liver disease, is increasing year by year, and it has become one of the fastest rising causes in some developed countries. more and more studies have also confirmed that the levels of different kinds of lipids and their metabolites are correlated with the development of hepatocellular carcinoma. in this study, the researchers performed qualitative and quantitative analyses of various common lipid metabolites in plasma and liver cancer tissues of hepatic resection patients with hepatocellular carcinoma, collected tumor-related pathological data from the patients, and investigated the correlation between the lipid metabolites and the development of hepatocellular carcinoma, in order to provide a new idea for the early diagnosis and treatment of primary hepatocellular carcinoma, as well as for screening of hepatocellular carcinoma markers.


Eligibility criteria:
inclusion criteria: * patients aged 18-80 years old undergoing hepatic resection for hepatocellular carcinoma (diagnostic criteria for hepatocellular carcinoma refer to the guidelines for the diagnosis and treatment of primary hepatocellular carcinoma). * voluntary signing of informed consent exclusion criteria: * in the judgment of the investigator, they are not suitable to participate in this study. * patients with hepatic malignant tumors with invasion of the main portal vein and its first-order branches, the common hepatic duct and its first-order branches, the main hepatic vein and the inferior vena cava, or extrahepatic metastases. * surgery with biliary tract exploration or reconstruction in the presence of biliary obstruction. * surgery combined with splenectomy or splenic artery ligation * preoperative combination of cardiac, pulmonary, renal and other organs with major underlying diseases.
study of 18f-fapi applied to gastrointestinal cancer

Conditions: Gastrointestinal Cancer

Summary: comparison of tumor volume, number, and suvmax of different primary foci (gastric, duodenal, and colon cancer), lymph node metastases (neck and supraclavicular, mediastinal, abdominal, and pelvic), and distant metastases (brain, lung, liver, bone, pleura, and peritoneum) detected by 18f-fapi versus 18f-fdg pet/ct imaging.


Eligibility criteria:
inclusion criteria: * patients with high clinical suspicion of gastrointestinal tumor and negative 18f-fdg at first diagnosis * post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18f-fdg exclusion criteria: * the diagnosis can be clarified by 18f-fdg pet/ct examination * the presence of recurrence or metastasis can be clarified by 18f-fdg pet/ct examination
efficacy and safety of defocusing frame glasses with artificial intelligence in controlling myopia progression

Conditions: Myopia

Summary: background: myopia refers to the pathological state in which the external parallel light enters the eye and focuses in front of the retina, resulting in the inability to clearly image on the retina. the number of myopia in china ranks first in the world. according to statistics from the national health and health commission, the myopia rate of children and adolescents nationwide in 2020 will be as high as 52.7%. high myopia often leads to permanent visual impairment and even blindness. retinopathy complicated by high myopia has become the first irreversible blinding eye disease in shanghai and other regions. the problem is severe. therefore, it is necessary to actively seek effective myopia treatment and correction methods to slow down the progression of myopia and the excessive extension of the eye axis and reduce the occurrence of complications. objective： on the basis of previous research, this study put forward the hypothesis that if behavior management (including outdoor light exposure and close-range eye-use behavior) can be strengthened in children with myopia wearing defocusing frame glasses, it is possible to achieve more effective myopia control effect, thereby not only ensuring safety also effectiveness. a randomized controlled clinical trial is conducted to evaluate the efficacy and safety of defocusing frame glasses with artificial intelligence in controlling myopia progression in children and adolescents. intervention: group 1 ( ai defocusing frame glasses group), group 2 ( ordinary defocusing frame glasses group). the study period will be 2 years and each participant will be followed up every six month.


Eligibility criteria:
inclusion criteria: * the cycloplegic refraction of two eyes is \[-0.50d, -5.0d) the astigmatism is ≥ -1.50d; or the cycloplegic refraction of either eye is \[-5.00, -10.00d), the astigmatism is ≥ -2.50d; * willingness to wear only trial-provided defocusing frame glasses during the trial * have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required; * written informed consent of guardian and child. exclusion criteria: * allergy or intolerance to cycloplegic drugs; * the anisometropia is greater than 1.50d; * using atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc. for myopia treatment; * strabismus/amblyopia; * history of eye surgery (including strabismus correction); * ocular or systemic diseases that may be related to the development of myopia or myopia: such as marfan syndrome, neonatal retinopathy, diabetes, etc.; * corneal, conjunctival or eyelid damage or other diseases (keratoconus, herpes simplex keratitis, etc.); * there are anatomical or skin factors that affect the wearing of spectacles; * other circumstances that the investigator judges inappropriate to participate in the trial.