Kornimate/medical-research-clean huggingface dataset:
renovate fibrosis:hfnc versus nippv in acute respiratory failure in patients with pulmonary fibrosis

Conditions: Acute Respiratory Failure; Pulmonary Fibrosis

Summary: a pilot multicentric randomized controlled study investigating the feasibility of recruiting 50 pulmonary fibrosis patients in acute respiratory failure within18 months. additionally, exploratory efficacy and safety outcomes will be evaluated.

renovate fibrosis will recruit patients with pulmonary fibrosis in acute respiratory failure to be randomized to hfnc or nippv. efficacy and safety outcomes measured are dyspnea variation, physiological variables (pco2, respiratory rate, oxygenation), comfort, endotraqueal intubation rate, mortality in 28 and 90 days.

Eligibility criteria:
inclusion criteria: sequential adult patients 18 years of age or older admitted to the hospital with pulmonary fibrosis and acute onset of respiratory failure that meets criteria a and b bellow. a. pulmonary fibrosis will be defined by all of the criteria below: * presence of velcro-type crackles on physical examination * imaging compatible with pulmonary fibrosis * diffuse disease on imaging b. acute respiratory failure (arf) will be defined by hypoxemia evidenced by spo2 \<90% or pao2 \<60 mmhg in room air and at least two of the criteria below within the last four weeks: * worsening dyspnea * worsening breathing effort * worsening gas exchange (worsening spo2 or pao2) * worsening respiratory rate, above 25 irpm exclusion criteria: * pulmonary fibrosis secondary to progressive massive fibrosis (silicosis), or any other tumor form of fibrosis; * significant pulmonary arterial hypertension characterized by: right ventricular failure on doppler echocardiogram or cardiac index \<2l / min / m2 in catheterization of right chambers; * pneumothorax or extensive pleural effusion as the main determinant of arf in the assessment of the attending physician; * cardiogenic pulmonary congestion as the main determinant of irpa in the assessment of the attending physician; * presence of delirium or non-cooperation at the time of randomization; * anatomical facial abnormalities; * incoercible vomiting or hypersecretion of the airways; * use of continuous vnipp or hfnc for more than 8h before randomization; * pregnancy; * refusal to participate.
a phase 2, multicenter, randomized, open-label study of medi-551 in adults with relapsed or refractory diffuse large b-cell lymphoma (dlbcl)

Conditions: Diffuse Large B-Cell Lymphoma

Summary: the overall purpose of the study is to determine if medi-551, when used in combination with salvage chemotherapy, ifosfamide-carboplatin-etoposide (ice) or dexamethasone-cytarabine (dhap) in patients with relapsed or refractory dlbcl who are eligible for autologous stem cell transplant (asct), has superior efficacy compared to rituximab in the same population.


Eligibility criteria:
inclusion criteria: * histologically confirmed aggressive b-cell dlbcl, including fl transforming to dlbcl \& grade iii fl * relapsed from or refractory to at least one treatment containing rituximab or another anti-cd20 based immunotherapy combined with anthracycline- or anthracenedione-based chemotherapy * eligible for asct * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * life expectancy of ≥ 12 weeks * adequate hematological function exclusion criteria: * any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment * previous cancer therapy for dlbcl other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy * prior autologous or allogeneic sct * new york heart association ≥ class ii congestive heart failure; clinically significant abnormality on ecg * history of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ. * evidence of active infection * documented current central nervous system involvement by leukemia or lymphoma

Keywords: lymphoma, non-hodgkin's lymphoma, diffuse large b-cell lymphoma, dlbcl, b-cell malignancy, anti-cd19, monoclonal antibody, second line, asct, refractory
proliferative lupus nephritis treatment with chloroquine and hydroxychloroquine

Conditions: Proliferative Nephritis; Chloroquine Retinopathy

Summary: evaluation the efficacy of chloroquine and hydroxychloroquine in the treatment of proliferative lupus nephritis class iii and iv in children and adolescents and evaluate the side effects of both drugs .

all patients will fulfill the diagnostic criteria of sle. the diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. the criteria set developed by the american college of rheumatology (acr) and diagnosed wih lupus nephritis class iii and iv . inclusion criteria: * children and adolescents who fulfill diagnostics criteria of sle and diagnosed with lupus nephritis class iii and iv. * all patients will be received steroids , mmf and angiotensin converting enzyme. exclusion criteria: * patients diagnosed with lupus nephritis class i,ii,v and vi. * patients received cyclophosphamide in stead of mmf.

Eligibility criteria:
inclusion criteria: * children and adolescents who fulfill diagnostics criteria of sle and diagnosed with lupus nephritis class iii and iv. * all patients will be received steroids , mmf and angiotensin converting enzyme. exclusion criteria: * patients diagnosed with lupus nephritis class i,ii,v and vi. * patients received cyclophosphamide in stead of mmf.
vit d receptor gene polymorphism

Conditions: Vitamin D Status

Summary: the present cross-sectional observational study was conducted after the university ethical committee approved the research (nu/cec/2020/0339). this study included 376 adults in the age group of 18-40yrs. the patient information sheet briefed the study details and usage of salivary samples. informed consent was obtained from participants. healthy individuals free of associated systemic conditions, individuals not under any nutritional supplementation were included in the study, and lactating mothers, smokers, and menopausal women were excluded

the present cross-sectional observational study was conducted after the university ethical committee approved the research (nu/cec/2020/0339). this study included 376 adults in the age group of 18-40yrs. the patient information sheet briefed the study details and usage of salivary samples. informed consent was obtained from participants. healthy individuals free of associated systemic conditions, individuals not under any nutritional supplementation were included in the study, and lactating mothers, smokers, and menopausal women were excluded. further, the subjects were divided into active and caries-free based on caries experience. two indexing methods were utilized to record the decay status, i.e., decay, missing, filled (dmft) and pulpal, ulcerative, fistula (pufa) scores. caries active group was further divided into a high-risk group (dmft=\< 10), moderate risk (dmft= 4-9), and low risk (dmft=1-3). questionnaire: baseline information was gathered, including specifics on age, sex, height, weight, dietary preferences (non-veg/veg), and dental hygiene practices.

Eligibility criteria:
inclusion criteria: * healthy individuals free of associated systemic conditions * individuals not under any nutritional supplementation exclusion criteria: * lactating mothers * smokers * menopausal women

Keywords: vitamin d gene polymorphism dental caries cathelicidins
the utility of multiplex pcr for detection of dna in neutropenic patients with hematological malignancies

Conditions: Neutropenia

Summary: objectives: invasive infections are the leading cause of morbidity and mortality in patients treated for hematological malignancies. blood cultures are often negative in neutropenic patients because of low-burden of organisms, previous antibiotic therapy or non-infectious reason of fever. more rapid, accurate and sensitive diagnostic tools are needed. hypothesis: multiplex real-time pcr may detect microbial dna in neutropenic patients before febrile episode. to investigate this hypothesis, edta-blood was routinely collected for multiplex pcr at admission and 3x/week thereafter until discharge or recovery from neutropenia


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years * autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy performed exclusion criteria: * no blood samples were taken

Keywords: neutropenia multiplex pcr infection
safety and pharmacodynamics of sel-037 (pegsiticase) in subjects with elevated blood uric acid levels

Conditions: Gout

Summary: this study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of sel-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted.

this study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of sel-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted. cohorts of subjects will be given a single, ascending dose intravenous infusion of sel-037 and then monitored for safety, uric acid levels and anti-drug-antibodies (adas) to sel-037 for 30 days.

Eligibility criteria:
inclusion criteria: * male or female subjects ages 21 to 75 inclusive. female subjects must be of non-childbearing potential; * has at the screening visit a serum uric acid ≥ 6 mg/dl, with or without a history of gout; * the use of allopurinol, febuxostat (uloric®), or probenecid as uric acid-lowering therapy is permissible if dosing has been stable for at least the month prior to the screening visit * has adequate venous access and able to receive iv therapy; * evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study; exclusion criteria: * prior exposure to any experimental or marketed uricase; * history of any allergy to pegylated products, * glucose-6-phosphate dehydrogenase deficiency or known catalase deficiency; * history of hematological or autoimmune disorders, is immunosuppressed or immunocompromised; * has participated in a clinical trial within 30 days of the screening;
randomized trial of primary surgery followed selective radiochemotherapy for rectal cancer with mri negative crm

Conditions: Colorectal Neoplasm; Effects of Radiation Therapy; Effects of Chemotherapy; Surgery

Summary: the purpose of this study is to determine whether primary radiotherapy can be omitted for the locally advanced rectal cancer with magnetic resonance imaging (mri) negative circumferential margin.

the preoperative radiochemotherapy with fluorouracil followed surgery is the standard therapy for patients with locally advanced rectal cancer. however, the necessity of radiotherapy has been questioned for a long time especially for patients with enough circumferential margins. moreover, indiscriminate radiotherapy will result irreversible ovarian dysfunction for female. in the past decade, there were two major progresses for colorectal cancer. firstly, oxaliplatin with fluorouracil has become the standard adjuvant chemotherapy for advanced colon cancer. oxaliplatin improved the survival of colon cancer patients than single fluorouracil. our experience showed that oxaliplatin with fluorouracil could improve the prognosis of rectal cancer without radiotherapy. it has been proven that oxaliplatin should not add to radiotherapy for rectal cancer. however, whether oxaliplatin can replace radiotherapy for certain rectal cancer patients is still unknown. secondly, magnetic resonance imaging (mri) has been proven that can predict the circumferential margin status for rectal cancer. now, preoperative mri scan can recognize the rectal cancer patients with low recurrence risk. the radiotherapy may be omitted to the patients with low recurrence risk. this study is a randomized controlled trial to compare the 3-year disease-free survival (dfs) differences of group of experiment (the patients receive primary surgery followed selective radiochemotherapy) and group of control (the patients receive indiscriminate preoperative radiochemotherapy followed surgery) for locally advanced rectal cancer with negative mri circumferential margin.

Eligibility criteria:
inclusion criteria: * rectal adenocarcinoma or mucinous adenocarcinoma that is 6-12 cm from the anal verge. * mri scan confirmed ct3n0 or ct4an0 or ct1-4an+ mid rectal cancer (6-12cm from the anal verge). * mri scan confirmed more than 1 mm circumferential margin. * age 18-75 years old. * without distant metastasis. exclusion criteria: * malignant history. * contraindications of mri scan. * contraindications of radiotherapy. * contraindications of chemotherapy. * pregnancy. * multidisciplinary team thinks that the patient is unsuitable to take part in research (for example, there are obvious regional lymph nodes involved in low rectal cancer patients who are thought with high risk of recurrence). * refuse to take part in research.
recurrences after standard emr vs plus thermal ablation emr

Conditions: Polyps of Colon; Recurrence, Local Neoplasm

Summary: the primary objective of this trial is to investigate whether thermal ablation emr with soft tip snare coagulation (stsc) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard emr.

rationale: lowering the emr recurrence rate will potentially lead to fewer colonoscopies resulting in less additional costs, less compliance burdens and less exposure to possible procedure related risks. objective: to investigate whether thermal ablation emr with snare tip soft coagulation (stsc) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard emr. study design: this study entails a patient-blinded multicenter prospective randomized controlled trial that will be conducted between january 2022 and may 2025 in 1 academic and 7 non-academic hospitals in the netherlands and it will take place in the outpatient clinics of the participating centers. study population: all patients aged ≥ 18 years with proven colorectal sessile of lateral spreading polyps (paris classification 0-iia/b/c, is) with a diameter of ≥ 20mm requiring piecemeal resection with emr are eligible for inclusion. intervention: snare tip soft coagulation of the entire emr margin is a technique for the removal of potential residual adenoma. main study endpoint: polyp recurrence after 6 months follow up. recurrence is evaluated histologically and endoscopically with biopsies taken during follow up colonoscopy.

Eligibility criteria:
inclusion criteria: * proven colorectal sessile or lateral spreading polyps with a diameter of ≥ 20mm requiring piecemeal resection with emr. exclusion criteria: * previously attempted intervention * polyps with any signs of invasive malignancy * presence or suspicion of inflammatory bowel disease * en bloc resection * incomplete resection

Keywords: snare tip soft coagulation emr
a study of shr8554 injection for the treatment of pain after orthopedic surgery

Conditions: Pain

Summary: the primary objective is to evaluate the analgesic efficacy of iv shr8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects requiring elective general anesthesia orthopedic surgery 3. conform to the asa physical status classification exclusion criteria: 1. subjects with a history of difficult airway 2. subjects with a history of reflux esophagitis 3. subjects with a history of mental illness 4. subjects with poor blood pressure control 5. transcutaneous oxygen saturation (spo2) \<90% 6. random blood glucose ≥11.1mmol/l 7. subjects with abnormal liver function 8. allergies to opioids and other medications that may be used during the trial
study of prognostic factors in aortic dissection type b

Conditions: Type B Aortic Dissection

Summary: clinical outcomes of chronic type b aortic dissections are unknown, especially in case of false lumen expansion and risk of rupture. data of literature give us some indications about prognosis. the 1-year survival rate is about 80%, but we deplore the 25% rate of mortality at 3 years despite follow-up.the only known predictive factors are the initial diameter of more than 4 cm and the persistence of a false lumen patent.however, actual means of follow-up do not allow to predict severe complications. the aim of the sudy is to propose a diagnostic and preventive strategy for the follow-up of chronic type b aortic dissections treated medically. the primary objective is then to evaluate the prognostic role of 18-fdg-pet scan in such patients in order to predict the risk of aortic diameter growth of more than 5 mm in 1 year and/or of an aortic dissections extension at 1 year. the secondary objectives are to evaluate the link between fibrosis biomarkers mmp et timp) and the results of imaging results (evolution of diameter and extension and results of pet-scan imaging) methods: 100 patients to be included in 3 years history of chronic type b aortic dissection, treated medically, evolving since more than 1 month and less than 5 years. expected results: prognostic contribution of 18fdg-pet-scan and biomarkers for the identification of patients at high risk of evolution. elaboration of a decisional algorithm about follow-up modalities of chronic aortic dissections. demonstration of a correlation between aortic diameter growth or aortic dissection extension and intensity of marker fixation with 18-fdg-pet-scan.


Eligibility criteria:
inclusion criteria: * patients over 18 years old * chronic type b aortic dissection, without surgical treatment * medically treated patient * medical treatment since more than 1 month and less than 5 years * aortic dissection localization : below left subclavian artery and alow femoral artery * affiliation to a social security system * patient who have given informed consent exclusion criteria: * history of malignant pathology * aortic dissection since less than 1 month or more than 5 years * inflammatory or infectious disease of the aorta * uncontrolled infectious disease * iodine allergy * severe renal insufficiency (cockcroft clearance \<30 ml/min) * patient under guardianship or curators * any associated medical or psychological condition wich could compromise the patient's ability to participate in the study * inability to be submitted to the study follow-up for geographical, social or psychological reasons * current pregnancy or lack of effective contraception during their reproductive years * suckle

Keywords: 18 fdg pet-scan angioscan aortic dissection
effects of remote ischemic conditioning on blood pressure in older patients with hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

current studies have shown that remote ischemic conditioning can improve vascular endothelial function and inhibit sympathetic nervous system activity. thus it may provide some organ protection as well as anti-hypertensive effects. the purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

Eligibility criteria:
inclusion criteria: * 1) age ≥65 years and ≤85 years, regardless of gender; * 2) history of essential hypertension and clinical systolic blood pressure ≥ 140 mmhg, regardless of whether they are receiving antihypertensive medication; * 3) willing to participate and sign the informed consent. exclusion criteria: * 1) secondary hypertension; * 2) clinical blood pressure ≥ 180/110 mmhg or 24-hour mean arterial pressure ≥ 170/100 mmhg; * 3) severe organ dysfunction or failure; * 4) severe hematologic disorders or significant coagulation abnormalities; * 5) history of atrial fibrillation or myocardial infarction within 6 months; * 6) individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc; * 7) individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc; * 8) those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment; * 9) other conditions that the researchers think are not suitable for the project.
a study to confirm the accuracy of locally advanced gastric cancer diagnosis

Conditions: Gastric Cancer; Gastric Cancer Stage; CT; Neoadjuvant Therapy

Summary: with the introducing of neoadjuvant therapy, it becomes ever more important to evaluate the preoperative tnm (ctnm) stage accurately facilitating preoperative treatment as well as the adjuvant therapy. at present, the recommendation of neoadjuvant chemotherapy varies among guidelines especially between eastern and western countries. according to the updated japanese gastric cancer treatment guidelines (ver.5), neoadjuvant chemotherapy is the recommended standard procedure for patients with ct2-4 stages. however, the acknowledgement of preoperative therapy accompanied by the higher risk of overtreatment. as mentioned in jcog1302-a, the overall precision rate in ct staging is 38.8%. patients diagnosed with pi stages postoperatively account for 6.5% in ct3-4n+ treatment indicating more likely to avoiding the overtreatment comparing to patients with other ct stages. inspired by jcog1302-a, this multicentre study prospectively collect data in preoperative tnm staging assessment using ct(computed tomography, ct) scan and the postoperative tnm (ptnm) staging according to histopathologically examination. by analyzing the accordance between the ctnm and ptnm, this study aims to evaluate the current accuracy of the ctnm staging in china, verifying the proportion of pi stages less than 5% in ciii stage diagnosis patients, learning the overtreating rate in neoadjuvant chemotherapy in china and furthermore, to discover the scope of beneficiaries for neoadjuvant chemotherapy.

objectives: i. confirm the inclusion of pathological stage i (pi) among clinical stage iii(t3-4anx) (ciii) diagnosis patients less than 5% ii. figure out the suitable criterion of nac and avoid overtreatment, by examining the rate of pi rate in different diagnostic criterion groups, including ciii, txny(x+y\>4), cn1-3, ct3-4. iii. evaluate the current state of diagnostic accuracy of preoperative ct staging in china. outline: this is a prospective, multi-centers, cohort study of clinical tnm staging diagnostic accuracy. patients are divided into 3 preoperative stage groups according to ajcc 8th edition (ci, cii, ciii) preoperatively. all patients receive the d2 gastrectomy after ctnm diagnosis and the pathological stages is given following surgery. the concordance of preoperative staging is evaluated in each cohorts as well as the subgroups to obtain the accuracy rate. the pi proportion will calculate in each latent criterion groups to assess the suitable nac criteria. projected accrual: a total of 968 patients will be accrued for this study within two years.

Eligibility criteria:
inclusion criteria: * histological prove of adenocarcinoma of the stomach by endoscopy * preoperative imaging data by contrast-enhanced ct and clinical tnm stages were given * no evidence of stage iv disease * no previous gastrectomy or preoperative treatment. exclusion criteria: * discovery of distant metastasis (stage iv) during surgery * number of retrieved lymph node less than 15

Keywords: gastric cancer clinical tnm staging adenocarcinoma