Kornimate/medical-research-clean huggingface dataset:
setting the shortest examination time of gastroscopy to improve the detection rate of upper gastrointestinal tumors

Conditions: Gastroscopy Time; Early Gastric Cancer; Detection Rate

Summary: this multicenter, prospective, interventional study aims to include 2000 gastroscopic procedures and investigate the relationship between procedure time and lesion detection rate in tertiary endoscopic centers in china. at the first stage, the researchers observe the actual procedure time of gastroscopies without affecting the natural behavior of endoscopists. at the second stage, a minimal time limit will be set for each procedure based on the observational results of the first stage. the primary study outcome is focal lesion detection rate. secondary outcomes include detection rate of early upper gi cancer, biopsy rate and adverse event rate.

china is a country with a heavy burden of gastric cancer and esophageal cancer. in 2015, the incidence/mortality of gastric cancer and esophageal cancer in china were 680000/500000 and 220000/200000, respectively. gastroscopy is the most important means to detect early cancer of gastrointestinal tract. however, due to various factors, the miss rate of clinical significant lesions by gastroscopy is innegligible. our previous research results showed that the detection rate of early gastric cancer and early esophageal cancer in china was only about 15%. this study aims to include 2000 gastroscopic procedures and investigate the relationship between procedure time and lesion detection rate in tertiary endoscopic centers in china. at the first stage, the researchers observe the actual procedure time of gastroscopies without affecting the natural behavior of endoscopists. then, researchers collect the data (including focal lesion detection rate, procedure time, detection rate of early upper gi cancer, biopsy rate and adverse event rate) and analyze the minimal procedure time. at the second stage, a minimal time limit will be set for each procedure. every stage last two months, and potential correlations between lesion detection rate and procedure time will be investigated through subsequent statistical analysis.

Eligibility criteria:
inclusion criteria: * no history of benign and malignant tumors (including carcinoma and adenoma) of upper gi (including esophagus, stomach and duodenum) * undergo gastroscopy with intravenous anesthesia (or conscious sedation) exclusion criteria: * subjects with focal lesions detected by gastroscopy within 1 year * subjects that cannot stand the gastroscopy procedure or cannot cooperate with endosccopists * emergency endoscopy and therapeutic endoscopy * subjects with history of esophageal or stomach surgery or endoscopic surgery * pregnant * subjects that taking antiplatelet or anticoagulant drugs which contradicts endoscopic biopsy * subjects with other serious complications that affect the speed of gastroscopy * subjects that refuse to cooperate with data collection or sign the informed consent
safety and efficacy of induced pluripotent stem cell-derived engineered human myocardium as biological ventricular assist tissue in terminal heart failure

Conditions: Heart Failure

Summary: the biovat-hf trial will test the hypothesis that cardiomyocyte implantation via engineered heart muscle (ehm), the proposed investigational medicinal product (imp; designated "biological ventricular assist tissue" or biovat), results in sustainable remuscularization and biological enhancement of myocardial performance in the failing heart. ehm are constructed from defined mixtures of induced pluripotent stem cell (ipsc)-derived cardiomyocytes and stromal cells in a bovine collagen type i hydrogel. comprehensive preclinical testing confirmed the rationale for the clinical translation of the myocardial remuscularization strategy by ehm implantation. the patient target population for ehm therapy is patients suffering from advanced heart failure with reduced ejection fraction (hfref; ef: ≤35%) and no realistic option for heart transplantation.


Eligibility criteria:
inclusion criteria: 1. hfref (ef ≤ 35%) as assessed by high-resolution echocardiography or mri 2. no realistic chance or not eligible for heart transplantation 3. at least one hypo- or dyskinetic segment to demark the implant target area 4. stable disease condition allowing for an elective left-lateral mini-thoracotomy (for lv applications) or open-chest surgery (for rv applications) for a clinically indicated intervention on the lv (e.g., coronary bypass surgery, valve repair) with concomitant rv dysfunction, diagnosed using the tricuspid annular plane systolic excursion (tapse) index \<16 mm (rudski et al. 2010). 5. 18-80 years of age 6. previous implantation of an icd or crt-d with event recorder 7. new york heart association (nyha) class iii or iv under optimal medical therapy 8. willingness and ability to give written informed consent 9. female subjects of childbearing potential must agree to use acceptable method(s) of contraception for the full study duration. exclusion criteria: 1. contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis b/c, hiv, htlv1) 2. alloimmunisation against ehm implant cells 3. hypertrophic cardiomyopathy (hcm) 4. terminal kidney failure (stage 4; gfr \<30 ml/min) 5. terminal liver failure 6. autoimmune disease 7. history of stroke 8. reduced life expectancy in the short term due to non-cardiac disease 9. simultaneous participation in another interventional trial 10. pregnant or breastfeeding females 11. known or suspected alcohol and/or drug abuse
macular hole after diabetic vitrectomy

Conditions: Proliferative Diabetic Retinopathy; Macular Holes

Summary: to present the clinical characteristics and rational treatment of macular hole (mh) after the diabetic vitrectomy (dv) in patients with proliferative diabetic retinopathy (pdr).

all patients had received initial vitrectomy to treat complications of pdr. recruited patients were divided to two groups: the persistent mh group, who had mh before the primary dv (group 1); and the newly-developed mh group, who developed mh after a successful primary dv (group 2). the patients' demographic data, records of ophthalmological examinations, and surgical procedures were collected, including best-corrected visual acuity before and after each operation, fundus changes, as well as mh repairing techniques. the extent of fibrovascular proliferation(fvp) was separated into four grades based on the severity of vitreoretinal adhesion : multiple-point adhesions with or without one site plaque-like broad adhesion (grade 1), broad adhesions in more than one but fewer than three sites, located posterior to the equator (grade 2), broad adhesions in more than three sites, located posterior to the equator or extending beyond the equator within one quadrant (grade 3), and broad adhesions extending beyond the equator for more than one quadrant (grade 4). the extent of retinal detachment (rd) was classified into "within the arcade" or "beyond the arcade". the macular structure was evaluated by optical coherence tomography (oct). all patients had a follow-up duration of more than three months after the final surgical procedures. three different surgical techniques were used to treat mh: standard internal limiting membrane (ilm) peeling, inverted ilm flap insertion into the mh, and lens anterior or posterior capsular flap insertion into the mh. the indication(s) for each technique were: standard ilm peeling was performed if no ilm peeling had been done in the previous surgery, and the mh size was less than 500um in an attached retina; inverted ilm flap insertion was performed if no ilm peeling had been done in the previous surgery, with a detached retina; lens anterior capsule flap insertion was performed if cataract surgery was performed in the same setting with no ilm tissue available; lens posterior capsule flap insertion was performed in a pseudophakic eye with no ilm tissue available. only descriptive statistics was obtained.

Eligibility criteria:
inclusion criteria: * proliferative diabetic retinopathy patients presenting with macular hole after primary diabetic vitrectomy * the persistent mh group after surgery, who had mh before the primary dv * newly-developed mh group, who developed mh after a successful primary diabetic retinopathy exclusion criteria: * patients with peripheral breaks * patients with macular hole before surgery, which closed after primary diabetic retinopathy * missing clinical data
laboratory study using samples from patients with non-small cell lung cancer treated on clinical trial case-2507

Conditions: Lung Cancer

Summary: rationale: studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and rna and identify biomarkers related to cancer. purpose: this laboratory study is looking at biomarkers in tumor tissue and blood samples from patients with non-small cell lung cancer.

objectives: primary * identify mutations in epidermal growth factor receptor (egfr) in non-small cell lung cancer specimens from clinical trial case-2507. * investigate egfr dna copy-number changes. * determine abnormalities of other pathways, such as the c-met and pi3k pathways as potential mechanisms of resistance. outline: this is a multicenter study. dna and rna are extracted from tumor samples. genomic dna is analyzed using real-time pcr/ reverse transcriptase pcr analysis and/or fish analysis in order to study resistance mechanisms such as secondary egfr mutations and the c-met and pi3k pathways. rna is analyzed using taqman quantitative pcr in order to determine the copy number of egfr expressed in these tissues. peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (epcam).

Eligibility criteria:
disease characteristics: * eligible for and concurrently enrolled on clinical trial case-2507 patient characteristics: * willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * normal coagulation profile and platelet count \> 100,000/mm³\* * not pregnant note: \*for patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy. prior concurrent therapy: * see disease characteristics * no concurrent anticoagulants (e.g., warfarin or low-molecular weight heparin) * no concurrent antiplatelet therapy (e.g., aspirin, clopidogrel, or other antiplatelet agents)\* note: \*for patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy.

Keywords: recurrent non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
outcome of induced atypical atrial flutter

Conditions: Tachyarrhythmia; Atypical Atrial Flutter; Induction of Arryhthmia; Clinical Outcome

Summary: background: atypical atrial flutter (aaf) is an increasingly relevant clinical problem. despite advancements in mapping and ablation techniques, the general management of these patients remain challenging especially when mapping cannot be performed during ongoing arrhythmia. there are no data whether induction of aaf is a feasible approach in these cases. methods: the investigators retrospectively analyzed patients who underwent catheter ablation of aaf and compared procedural results between patients with ongoing tachycardia when starting the procedure and patients with induced aaf. for this retrospective study, the investigators analyzed patients undergoing ablation of aaf between april 2018 and january 2021 that were identified from the ablation database at the west german heart and vascular center, essen. all patients were followed up in the outpatient clinic as part of the clinical standard routine or contacted by telephone to assess the occurrence of clinical recurrence of any arrhythmia. in case the documentation was not performed at the institution, relevant documents and ecgs were requested and reviewed. this single-center cohort study was conducted at the university hospital essen, germany, in accordance with the declaration of helsinki and its amendments and was approved by the institutional review board of the university of essen (number 21-10341-bo). written informed consent was obtained from all study participants. the primary study endpoint was to evaluate the outcome of patients with induced aaf in comparison to patients with ongoing aaf when starting the procedure. furthermore, the investigators analyzed the type of recurrence during follow-up as well as the occurrence and results of repeat ablations at the institution. the investigators also evaluated if the recurrent aaf form was the same or de-novo compared to the aaf during previous procedure.


Eligibility criteria:
inclusion criteria: * \>18 years * symptomatic atypical atrial flutter and electrophysiological study with ablation exclusion criteria: * inability to comply with follow up * participation in another trial that may interfere
influence of socioeconomic and environmental factors on the natural history of idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis; Pulmonary Disease; Pulmonary Medicine

Summary: idiopathic pulmonary fibrosis(ipf) is the most common idiopathic interstitial lung disease whose cause is unknown. with age and gender, socio-economic factors are the most influential indicators of health. at present there is very little data on socio-economic factors in the ipf. the investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the ipf's natural history, including the severity of diagnosis and prognosis of the ipf. the investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.

idiopathic pulmonary fibrosis is the most common idiopathic interstitial lung disease whose cause is unknown. however, it remains a rare disease, there is an incidence of approximately 4400 new patients per year in france. it is a serious disease with few therapeutic options and a median survival after diagnosis around 36 months. it is also responsible for high morbidity, with a marked deterioration in quality of life (dyspnea, cough, fatigue and anxiodepressive disorders) and significant functional impairment (respiratory failure) with age and gender, socio-economic factors are the most influential indicators of health. at present there is very little data on socio-economic factors in the ipf. the investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the ipf's natural history, including the severity of diagnosis and prognosis of the ipf. the investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.

Eligibility criteria:
inclusion criteria: * man woman over 18 years old * certain or probable idiopathic pulmonary fibrosis determined by a multi-disciplinary discussion ("ats / ers / jrs / alat" 2018 criteria) * idiopathic pulmonary fibrosis with a diagnosis of less than 12 months * signed informed consent * patient affiliated to a social security scheme or universal health coverage or benefiting from state medical aid exclusion criteria: * known cause of diffuse interstitial lung disease (including connectivity, hypersensitivity pneumonitis or pneumoconiosis authenticated) * patient unable to answer questionnaires * pregnant or lactating woman * persons under guardianship

Keywords: socioeconomic status air pollution environmental exposure occupational exposure idiopathic pulmonary fibrosis
efficacy and safety study of peginterferon beta-1a in participants with relapsing multiple sclerosis

Conditions: Relapsing Multiple Sclerosis

Summary: the primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (arr) in participants with relapsing multiple sclerosis (rms) at 1 year. the secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging t2 hyperintense lesions on brain magnetic resonance imaging (mri) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.

this is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled study. the treatment period is 96 weeks (2 years) in duration. treatment year 1 (week 0 to week 48) is referred to as the placebo-controlled treatment period of the study. at the beginning of treatment year 1, participants were randomized to receive placebo, peginterferon beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks. at the end of treatment year 1, participants in the placebo group were re-randomized to receive peginterferon beta-1a treatment so that during treatment year 2 (weeks 48 to week 96) all participants received peginterferon beta-1a 125 μg every 2 or every 4 weeks. per protocol, all primary and secondary endpoints pertain to year 1 data.

Eligibility criteria:
key inclusion criteria: * must have a confirmed diagnosis of relapsing multiple sclerosis (rms), as defined by mcdonald criteria 1 through 4 (polman, 2005) * must have an edss score between 0.0 and 5.0. * must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months key exclusion criteria: * other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease * pregnant or nursing women * prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to baseline note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: interferon injectable ms sc pegylated interferon beta-1a relapsing peg multiple sclerosis subcutaneous
corticosteroids with vedolizumab in crohn's disease

Conditions: Crohn's Disease

Summary: use of co-induction with corticosteroid therapies may accelerate the remission rate when used with vedolizumab. further, this may lead to higher rates of response and remission at week 10 than would be seen with vedolizumab monotherapy.

this study will examine prednisone co-induction with vedolizumab in patients with crohn's disease. to address questions regarding the effect of co-induction on mucosal healing, the study will include colonoscopic assessment of mucosal healing. finally, colonic biopsies in this study will allow to elucidate further the mechanism of action of vedolizumab in crohn's disease through immune phenotyping studies.

Eligibility criteria:
inclusion criteria: * age at entry 18 to 70 * cdai score \> 220 * concomitant azathioprine, methotrexate, or mercaptopurine permitted if dose has been stable for \> 8 weeks. prior anti-tnfα antibody use permitted but must be discontinued (\>2 weeks from last dose) prior to initiation of vedolizumab. * documented ulceration on colonoscopy done at screening of 3 or more large ulcers or 10 or more aphthous ulcers * able to provide written informed consent. * patient is planned for or eligible to initiate vedolizumab exclusion criteria: * concurrent use of anti-tnfα antibodies. * no corticosteroids within prior 3 months (other than budesonide controlled ileal release) * no stoma at the time of enrollment * no absolute contraindication to systemic corticosteroid use such as hypersensitivity to any part of the formulation, systemic fungal infection, or recent administration of live or live attenuated vaccine within prior two weeks. * pregnant women or plans for pregnancy within 3 months of study inclusion * presence of stoma, more than three small-bowel resections, or documented history of short bowel syndrome * intestinal stricture requiring surgery * abdominal abscess * inability or unwillingness to provide informed consent * any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study

Keywords: vedolizumab corticosteroids prednisone crohn's disease
oct explores vascular response and healing profile after stenting in cto

Conditions: Chronic Total Occlusion of Coronary Artery

Summary: true-false-true occurred during wire penetration in coronary cto procedure. subintimal stenting influences vascular response. intravenous ultrasound confirmed wire position in the procedure. then stenting procedure was performed. optical coherence tomography was used for exploring long-term vascular response and healing profile after successful coronary stenting in cto lesions.

chronic total occlusions (ctos) are defined as coronary lesions with thrombolysis in myocardial infarction (timi) grade flow of 0 and present for more than 3 months. cto is commonly recognized as the toughest lesion subset to be treated by percutaneous coronary interventions. with the remarkable progress in the technologies and techniques achieved in the pci for cto over the last decade, the rate of procedural success increased to 80-90%. chronic total occlusion is associated with a higher incidence of malapposition and uncovered stent struts. at present, four strategies were used for cto lesions, including: ante-grade wire escalation, ante-grade dissection reentry (adr), retro-grade wire escalation, and retrograde dissection reentry (rdr). true-false-true occurred during wire penetration. subintimal stenting influences vascular response. intravenous ultrasound (ivus) confirmed wire position in the procedure. then stenting procedure was performed according to standard routine. optical coherence tomography (oct) was used for exploring long-term vascular response and healing profile after successful coronary stenting in cto lesions.

Eligibility criteria:
inclusion criteria: * 18\~85 years old; * agree percutaneous coronary intervention without related contraindications; * chronic total occlusion confirmed by clinical and angiographic data, predicted high successful rate of stent implantation; * subjects (or legal guardians) understanding the testing requirements and procedures, and providing written informed consent. exclusion criteria: * subjects associated with drugs allergy (such as contrast, sirolimus, or structure-related compounds fluorinated polymers, thienopyridine or aspirin); * subjects with active peptic ulcer, active gastrointestinal (gi) bleeding or other bleeding diathesis or coagulopathy; * subjects being suffered from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 12 months; * pregnant or breastfeeding women; * refused this trial; * subjects with severe liver or renal dysfunction (alt \>5×uln，egfr\ 200 mmol/l); * active bleeding; * bleeding diathesis or coagulopathy, malignant tumors; * contraindication of anticoagulant drugs; * subjects with other situation not suitable for the study.

Keywords: subintimal stenting vascular response and healing optical coherence tomography