Kornimate/medical-research-clean huggingface dataset:
changes of exosomes and biomarkers in plasma and alveolar lavage fluid of patients with sepsis complicated with ards

Conditions: Sepsis Complicated With ARDS

Summary: in this study, serum samples and alveolar lavage fluid from patients with sepsis complicated with ards were studied. the differential mirnas of inflammatory exosomes in patients with sepsis lung injury were screened, and sestrin2, ho-1 and pparγ proteins, oxidative stress and inflammatory indexes in serum and alveolar lavage fluid were measured simultaneously, to explore the relationship between ho-1, oxidative inflammatory indexes and metabolic indexes. these results provide an important reference for assisting the management of ards disease and predicting the adverse outcomes of sepsis patients with ards.

1. title: study on exosomes and biomarkers in plasma and alveolar lavage fluid of patients with sepsis complicated with ards 2. research center: monocentric 3. the design of the study: randomized, double-blind 4. the population of the study: 1)age ≥18, no gender or ethnic limitation. 2) patients with sepsis who meet the criteria of sepsis -3 and ards is defined according to berlin standard. 5. interventions: within 24h after admission to icu, blood samples and alveolar lavage fluid were collected and transferred to a cleaning tube and stored in a refrigerator at -80°c for exosome sorting and identification, differential mirnas, and analysis of serum oxidation and inflammatory indicators. 7. the aim of the research: to explore the relationship between ho-1, oxidative inflammatory indexes and metabolic indexes and provide an important reference for assisting the management of ards disease and predicting the adverse outcomes of sepsis patients with ards. 8. outcome： differential mirnas of inflammatory exosomes were screened from patients with septic lung injury, and ho-1, pparγ or other positive indicators were used to regulate differential mirnas 9. the estimated duration of the study：2 years.

Eligibility criteria:
inclusion criteria: 1. age≥18 years old； 2. patients with sepsis who meet the criteria for sepsis -3； 3. agree to participate in this study and sign informed consent； exclusion criteria: 1. refuse to participate in this study； 2. patients with left atrial hypertension to prevent the inclusion of patients with abnormal oxygenation index due to cardiogenic pulmonary edema； 3. pregnant or lactation patients 4. patients are currently being enrolled in another study 5. the attending physician or researcher considers that there are other circumstances (reasons to be noted) that are not suitable for participation in this study.
reduction of prehospital delays in stroke and transient ischaemic attack (tia)

Conditions: Stroke

Summary: in patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. the aim of the present study was to reduce prehospital delays in a population-based intervention.the intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (ems). the investigators additionally included a bookmark and sticker with the ems telephone number. a total of 75,720 inhabitants received the intervention. between 2004 and 2005, 741 patients with cerebrovascular events were admitted from the control areas (n=24) and 647 from the intervention areas (n=24).

background and purpose: in patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. the aim of the present study was to reduce prehospital delays in a population-based intervention. methods: we performed a cluster-randomized trial with 48 zip code areas as cluster units in the catchment area of three inner-city hospitals in berlin. the primary endpoint was time between symptom onset and hospital admission. the intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (ems). we additionally included a bookmark and sticker with the ems telephone number. we fitted a lognormal survival regression model (time-to-admission) with frailty terms shared by inhabitants of the same zip code area.

Eligibility criteria:
inclusion criteria: * all patients with stroke or transient ischaemic attacks from the postal code areas of the study being admitted to one of the participating hospitals exclusion criteria: * patients with stroke or transient ischaemic attacks from outside the postal code areas of the study

Keywords: prehospital delays intervention population-based stroke
biib023 (anti-tweak) in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: phase i study designed to determine the safety and tolerability of a single dose of biib023 administered intravenously versus placebo to subjects with ra.


Eligibility criteria:
inclusion criteria: * diagnosis of adult onset ra (functional class i-iii) for at least 6 months * must have been treated with and be tolerating methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks * must have at least 4 swollen and tender joints due to rheumatoid arthritis exclusion criteria: * history of recurrent infections requiring antibiotic treatment within 12 months * serious local infection or systemic infection within 3 months * suffering from rheumatic or autoimmune disease other than ra * history of cancer, heart failure, kidney disease, liver disease, hiv infection, tuberculosis or other serious illness
self-expandable metal stent (sems) endoscopic placement for malignant colonic obstruction therapy

Conditions: Neoplasms,Colorectal

Summary: compare the effectiveness of self-expandable metal stent (sems) and diverting stoma formation for the bowel preparation as a bridge to surgical treatment of patients with mco.

surgical treatment of mco is associated with high mortality and frequent development of postoperative complications. stoma formation is the traditional method of urgent treatment of mco. currently there are more than 150 methods of colorectal stomas formation, but all of themare associated with a high risk of complications (10-20%), inclusively both early and late postoperative period. it results in longerhospital stay and requires additional financial expenses, also reoperations can be fatal for patients. analysis of recent publications devoted to the treatment of mco shows increasing implemented of new strategies of patents management, such as "fast track surgery", or "fast track recovery strategy" in clinical practice. minimally invasive endoscopic procedures as a first stage of mco treatment leads to transformation of previously performed multi-stage surgical interventions into one - stage. development of up-to-date endoscopic science and technology provides a wide usage ofself-expandable metal stent (sems) in clinical practice. this strategy helps to avoid stoma formation or emergency surgery, becoming a "bridge" to a radical surgery. there are currently no studies directly comparing discharge stoma with endoscopic self-expandable metal stenting in preparation for colorectal cancer radical surgery.

Eligibility criteria:
inclusion criteria: 1. patients are 18 years old or older 2. stage i-iv according to tnm classification 3. patients with malignant colonic obstruction 4. overall health status according to asa classification: i-iii 5. overall health status according to charlson comorbidity index ≤ 8 points 6. signed informed consent with agreement to attend all study visits 7. the patient is not pregnant exclusion criteria: 1. inflammatory bowel disease 2. acute purulent process in the abdominal cavity 3. the patient wants to withdraw from the clinical trial 4. loss to follow-up
assessment of symptoms and consequences of coloanal continuity reconstruction

Conditions: Rectal Cancer

Summary: this study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. this will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.

first of all, an information document will be given to the patients and their consent will be collected. then, they will be registered through the online ecrf (or by fax) and a study number will be given to each patient. the study will proceed with 2 stomatherapy consultations at one and six months after coloanal continuity reconstruction. patient care and following up will proceed as usual. the stomatherapy consultation will be done by a qualified nurse. before the 1st intervention (proctectomy): * collect of clinical data and disease history * quality of life questionnaires (eortc-qlq-c30 and cr29) * evaluation of lars score after the 1st intervention (proctectomy, at month 1): - quality of life : eortc-qlc30 and cr-29 questionnaires and stom-qol before the 2nd intervention (coloanal continuity reconstruction): - quality of life : eortc-qlc30 and cr-29 questionnaires and stom-qol after the 2nd intervention (at month 1, month 3, month 6 and one year): * at 1 and 6 months : clinical exam (stomatherapy consultation) for collect of postoperative complications * quality of life : eortc-qlc30 and cr-29 questionnaires and lars score

Eligibility criteria:
inclusion criteria: * 18 to 70 years old * patients who are going to undergo a proctectomy for a rectal cancer (situated at a distance equal or lower to 15 cm from the anoderm) following by a coloanal continuity reconstruction (using direct, latero-terminal or colonic j-pouch anastomosis) * already underwent or not a neoadjuvant radio-chemotherapy * affiliation to the national social security system * with informed and signed consent exclusion criteria: * unwilling patients * patient deprived of their liberty or under guardianship or tutorship. * abdominal perineal amputation * no stoma placement planned * tumor more than 15 cm from the anal margin

Keywords: proctectomy coloanal continuity reconstruction
a multi-omics study of braf v600e mutant colorectal cancer

Conditions: BRAF V600E-mutant Metastatic Colorectal Cancer

Summary: this trial aims to elucidate the immune landscape and genetic basis of braf-mutant colorectal cancer (crc) in chinese patients by analyzing tumor tissue and peripheral blood. single-cell rna sequencing, t cell receptor (tcr) sequencing, proteomics and metabolomics, will be performed on tumor tissues, alongside tcr sequencing of peripheral blood, to establish a comprehensive immune and genetic profile of braf-mutant crc. the study seeks to identify novel immune biomarkers, therapeutic targets, and signaling pathways, and to enable molecular subtyping for precision treatment and personalized management of braf-mutant crc patients.

as an oncogenic gene, braf v600e subverts the need for continuous upstream activation and overcomes negative feedback signals that terminate pathway activation. in colorectal cancer, braf v600e mutations are associated with older age, right colon primary tumors and female gender, as well as reduced chemotherapy sensitivity and poor prognosis. in addition to a poor prognosis, braf v600e-mutant colorectal cancer is associated with a higher incidence of peritoneal metastasis, resulting in tumor-related symptoms such as pain, ascites, gastrointestinal and urinary obstruction, which severely compromise patients' quality of life. although there is a trend that braf v600e mutant patients who receive high-intensity chemotherapy have longer progression-free survival (pfs), the prognosis of the braf v600e mutant population remains dismal and approximately 40% of patients do not respond to first-line high-intensity chemotherapy. in addition, the response rate of combined targeted therapy is limited to around 25% and the duration of anti-epidermal growth factor receptor (egfr) and anti-braf is around 4 months due to the presence of bypass activation. what's more, patients with braf v600e mutation and mismatch repair-proficient (pmmr) also had a poor response to anti-programmed death-1 (pd-1) therapy. the tumor heterogeneity and tumour immune microenvironment of braf v600e mutant colorectal cancer need to be investigated. the study seeks to identify novel immune biomarkers, therapeutic targets, and signaling pathways, and to enable molecular subtyping for precision treatment and personalized management of braf-mutant crc patients.

Eligibility criteria:
inclusion criteria: 1. written informed consent to study procedures; 2. men and women aged ≧18 years; 3. diagnosis of histologically or cytologically confirmed colorectal cancer; 4. first-generation sequencing or next-generation sequencing at any time prior to screening confirms the presence of braf v600e mutation in tumor tissue. exclusion criteria: 1. patients with serious heart disease, hypertension, cerebral hemorrhage or uncontrollable systemic diseases (such as: diabetes, hypertension, pulmonary fibrosis and acute pneumonia); 2. women who are pregnant or nursing; 3. unable to co-operate in sampling; 4. received more than two prior regimens of systemic cancer therapy for colorectal cancer.
endocuff-assisted versus standard colonoscopy for adenoma detection

Conditions: Polyp; Adenoma; Cancer

Summary: the endocuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal. the study hypothesis is that the use of the endocuff (ec) increases the adenoma detection rate during colonoscopy. the study purpose is to compare ec-assisted colonoscopy with standard colonoscopy for polyp detection.


Eligibility criteria:
inclusion criteria: indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent exclusion criteria: * pregnancy * age\<18 years * known colonic strictures * chronic inflammatory bowel disease * active inflammation * s/p colonic resection

Keywords: colon cancer adenoma colon polyps
a randomized comparison of clopidogrel monotherapy versus extended dual-antiplatelet therapy beyond 12 months after implantation of drug-eluting stents in high-risk lesions or patients; a-close trial

Conditions: Coronary Artery Disease; DES

Summary: we hypothesized that clopidogrel mono-therapy will not be inferior to the extended dapt in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (des) implantation.

patients at high risk for either ischemic or bleeding complications, but who were stable without clinical evetns for 12 months after des implantation will be included in this study. eligible patients will be randomized to continue dapt (aspirin plus clopidogrel) for further 24 months or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone). randomization will be stratified according to 1) clinical presentation (acute coronary syndrome or stable coronary artery disease) and 2) age (≥75 or \<75). baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. all patients will provide informed consent on their own initiative. all of study subjects will be have an outpatient visit as scheduled in outpatient clinic. occurrence of study endpoints will be documented at clinical visit or telephone interview every 6 months up to 24 months after randomization. antiplatelet drugs will be open-label and prescribed by attending physician.

Eligibility criteria:
inclusion criteria (must all met) 1. patients \>19 years old 2. patients who underwent des implantation 12 months (-1 to +5 months) previously. 3. high risk characteristics (clinical or lesion) for ischemic events (must at least one) high risk patients; clinical criteria 1. acute coronary syndrome 2. previous history of cerebrovascular accidents 3. history of peripheral artery intervention 4. heart failure (left ventricular ejection fraction ≤40%) 5. diabetes treated with medication 6. chronic renal insufficiency including end-stage renal diseases high risk lesions; angiographic or procedural criteria 1. left main diseases 2. bifurcation lesions 3. chronic total occlusion 4. in-stent restenotic lesions 5. graft lesions 6. diffuse long lesions requiring total stent length ≥28 mm 7. calcified lesions requiring atherectomy 8. multivessel coronary artery disease with multiple stents 9. small vessel disease requiring stent diameter of ≤2.5 mm exclusion criteria 1. age\> 80 years 2. pregnant women or women with potential childbearing 3. life expectancy \< 1 year 4. refusal or inability to understand of informed consent 5. need for chronic oral anticoagulation 6. history of major bleeding within 3 months prior to randomization

Keywords: patients who underwent percutaneous coronary intervention with des implantation carrying high risks for the recurrent major adverse events. anti platelet therapy bleeding
real-world effectiveness of hpv vaccine in women living with hiv and its impact on cervical cancer screening accuracies

Conditions: Hiv; Hpv

Summary: this study will examine both human papillomavirus (hpv) vaccine effectiveness and primary high-risk hpv phs screening triage strategies in women living with hiv (wlhiv) by partnering with the pediatric hiv/aids cohort study (phacs) led, in part, by our investigative team. among wwh, the study will examine the effectiveness of the hpv vaccine the study will screen approximately 810 wwh using a self-sampling kit and those who are phs\[+\] will attend a clinical visit to have colposcopy/biopsy and 4 triage tests. wwh with \<cin 2+ are asked to return annually for colposcopy and hpv genotyping for up to 3 yrs. wwh phs\[-\] will be asked to return in year 2 for rescreening. those phs\[+\] will be followed as above and phs\[-\] will be asked to obtain self-collected vaginal samples for hpv genotyping annually for 3 years.


Eligibility criteria:
inclusion criteria: * at least 21 years of age and less than or equal to 40 years of age; * wlhiv regardless of mode of transmission or hpv vaccination status; * current enrollment in the pediatric hiv/aids cohort study (phacs),surveillance monitoring for art toxicities (smartt), adolescent master protocol for participants 18 years of age and older (amp up), adolescent master protocol for participants 18 years of age and older - lite (amp up lite), or health outcomes around pregnancy and exposure to hiv/arvs (hope) studies; * willing to participate and able to provide informed consent; * willing to grant access to other phacs/hope data; and * willing to provide access to medical records. exclusion criteria: * currently known to be pregnant via self-report at hrhpv screening for initial consent; * special consideration: women who test positive on urine pregnancy test at the baseline colposcopy visit will be asked to defer their colposcopy until after 6 weeks following the end of the pregnancy. however, pregnancy during follow-up will be allowed, and guidelines for endocervical curettage (ecc) and treatment will be followed.39 * women known to have active cin 2 or greater, undergoing active surveillance with colposcopy (per participant report); * women with known bleeding disorders; * women unable to consent for themselves; and * women with a hysterectomy with removal of the cervix will be excluded from the study and, if such a procedure is conducted during the participant's study enrollment, the individual will be censored from analysis at the last visit prior to the hysterectomy and taken off-study.

Keywords: hpv vaccine effectiveness among those living with hiv biomarker evaluation for triage of primary hpv cervical cancer screening.
interdialytic kt/v variability measurement with adimea (ivp study)

Conditions: Kidney Disease

Summary: session-to-session variations in delivered kt/v that may cause failure to achieve the prescribed dialysis dose may be significant in regular clinical practice. to date, this is not recognized due to monthly blood kt/v measurements only. suboptimal delivery of prescribed dialysis dose may be caused by low effective treatment time, vascular access dysfunction, hemodynamic stability, blood pump speed, membrane influences, lab value variability or others which may vary from session to session. patients close to recommended target limits of dialysis dose may thus be "randomly" attributed to be adequately or inadequately dialyzed. therefore, in the literature, use of average kt/v values is recommended. adimea allows easy kt/v determination in every session and thus documentation of the monthly achieved kt/v in patients who repeatedly miss kt/v. knowledge, therefore, of session-to-session variability as well as knowledge of dialysis dose monitoring at every dialysis may enhance and secure delivery of adequate dialysis. the main objective is the estimation of the pooled within-patient sds (standard deviation) for single treatment adimea and of urea kinetic modeling (ukm)/ blood spkt/v. failure of kt/v\>1.2 delivery as well as its potential causes will be assessed. spkt/v target achievement is assessed by monitoring dose by adimea at every dialysis. this shall demonstrate that session-to-session variability can be decreased with usage of adimea.


Eligibility criteria:
inclusion criteria: * patient on chronic hemodialysis for at least 6 months * thrice dialysis therapy weekly * stable fistula access * documented three, monthly blood spkt/v from 1.0 to 1.4 or * average of spkt/v\<1.35 out of three consecutive blood measurements * age ≥ 18 years * voluntary participation and written informed consent exclusion criteria: * severe hematologic disorders (e.g. multiple myeloma) * life expectancy less than 6 months * single-needle dialysis * patient was monitored with adimea

Keywords: hemodialysis dialysis dose