Kornimate/medical-research-clean huggingface dataset:
novel dose adjustment schedule for late injection in scit in ar

Conditions: Allergic Rhinitis; Immunotherapy

Summary: allergen specific immunotherapy is currently the only curative intervention for allergic rhinitis (ar). subcutaneous immunotherapy (scit) need to be reinstituted with an interruption of more than 16 weeks in maintenance period, leading to increased time and economic cost burden and difficulties for continuing further treatment for patients. the aim of present study was to develop a novel dose adjustment schedule for such situation and to compare the clinical efficacy and adverse reactions between novel and conventional schedules for dust mite (dm) scit of ar subjects.


Eligibility criteria:
inclusion criteria: * (1) aged 18 to 60 years; * (2) only had a positive response to der p and der f but no other inhalant allergens based on euroline allergy diagnostics (beijing oumeng biotechnology co., ltd., beijing, china). meanwhile at least der p -specific ige (sige) in serum of was ≥ 0.7 ku/l (cap pharmacia, uppsala, sweden) using immunocap system (pharmacia, uppsala, sweden) regardless of the result of der p -specific ige in serum; * (3) had reached cluster scit maintenance period and the overall treatment time was more than 1 year but less than 2 years; * (4) hope to continue to complete the entire treatment and have good compliance. exclusion criteria: * (1) diagnosed as asthma based on the guidelines of the global initiative for asthma(13); * (2) had grade ii or above systemic adverse reactions occurred in the past scit period.
gait analysis and neuromuscular function after primary total hip replacement

Conditions: Osteoarthritis

Summary: this study is conducted at odense university hospital(ouh) in collaboration with institute of clinical biomechanics and sport science, university of southern denmark and clinical institute, university of southern denmark aim: to evaluate the effect of implant design on postoperative total leg muscle function recovery and gait in hip replacement patients. design: a prospective randomized controlled clinical trial where patients are randomized into (a) total hip arthroplasty surgery (tha) or (b) resurfacing total hip replacement surgery (rtha). pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks post-surgery.

the project consist of three substudies: * determination of test-retest reliability and agreement of specific mechanical muscle function variables for the patients of interest. * evaluate the effect of implant design on postoperative mechanical muscle recovery * evaluate the effect of implant design on postoperative gait

Eligibility criteria:
inclusion criteria: * primary arthrosis exclusion criteria: * osteoporosis, (t-score \< 2.5 sd) of proximal femur * bmi \> 35 * severe acetabulum dysplasia (ap centre edge \< 15-20°) * femur anteversion \> 25° * severe caput deformity * leg length discrepancy \> 1 cm * off-set problems * earlier fracture of the ipsilateral proximal femur * rheumatoid arthritis * neuromuscular or vascular disease

Keywords: mechanical muscle function muscle strength hip replacement osteoarthritis hip arthroplasty
estrogen receptor-positive breast cancer patient-derived xenografts

Conditions: Breast Cancer

Summary: the investigators will establish a platform at dartmouth-hitchcock medical center to generate novel models of estrogen receptor alpha-positive (er+), human epidermal growth factor receptor 2-negative (her2-) breast cancer, which will be used for research studies to develop novel treatment strategies and dissect signaling pathways underlying drug sensitivity and resistance.


Eligibility criteria:
inclusion criteria 1. men and women \> age 18 with histologically documented er+/her2- breast cancer or with a history of er+/her2- breast cancer, for whom a tumor biopsy or surgical resection is clinically indicated and will be performed as standard of care. tumor specimens may be from breast (progressive or recurrent) or metastatic sites. patients with multicentric or bilateral disease are eligible. 2. patients must have disease progression during neoadjuvant therapy, recurrence after neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic disease. 3. er positivity is defined as \>10% of malignant tumor cells staining positively for er by immunohistochemistry (ihc). her2 negativity is defined as ihc 0-1+, or with a fluorescence in situ hybridization (fish) ratio of \<1.8 if ihc is 2+ or if ihc has not been done. 4. excess live tumor tissue must be available from the surgically resected tumor specimen, or from 1-3 extra core needle or incisional biopsy. live tumor tissue must be available within 2 hours of removal from patient (shorter time is preferable). 5. a recurrent or progressing breast cancer must be greater than 1 cm in greatest diameter. 6. prior therapy is allowed as long as excess viable tumor tissue is available from the biopsy or surgical excision procedure. 7. patients must be willing to provide 6 ml of blood, which can be obtained during a routine clinically indicated blood draw (ideally, done on the same day as the tumor biopsy/surgery). 8. ability to give signed informed consent. exclusion criteria 1. fine needle aspirates and effusions of bodily fluids are not eligible as sources of tumor cells.

Keywords: estrogen estrogen receptor er+ her2 her2- her2-negative xenograft co-clinical mice patient-derived xenograft patient-derived breast cancer precision medicine personalized medicine
a randomized phase 2 study of atezolizumab (an engineered anti-pdl1 antibody) compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer who have failed platinum therapy - "poplar"

Conditions: Non-Small Cell Lung Cancer

Summary: this multicenter, open-label, randomized study will evaluate the efficacy and safety of atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. participants will be randomized to receive either atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m\^2) intravenously every 3 weeks. treatment with atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


Eligibility criteria:
inclusion criteria: * adult participants, \>/= 18 years of age * locally advanced or metastatic (stage iiib, stage iv, or recurrent) non-small cell lung cancer (nsclc) * representative formalin-fixed paraffin-embedded (ffpe) tumor specimens * disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic nsclc or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen * measurable disease, as defined by recist v1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * known active or untreated central nervous system (cns) metastases as determined by ct or mri evaluation during screening and prior radiographic assessments * malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome * history of autoimmune disease * history of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest ct scan. history of radiation pneumonitis in the radiation field (fibrosis) is permitted. * active hepatitis b or hepatitis c * prior treatment with docetaxel * prior treatment with cd137 agonists, anti-ctla4, anti-pd-1, or anti-pd-l1 therapeutic antibody or pathway-targeting agents
patient and physician preference study in resectable, non-small cell lung cancer treatments

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study is to investigate the perspectives and preferences of patients and healthcare professionals (medical oncologists, pneumologists, thoracic surgeons) regarding treatment options in the resectable non-small cell lung cancer (nsclc) setting


Eligibility criteria:
inclusion criteria: patients * aged ≥18 years at the time of enrollment in the study * resident of the us, germany, or japan * able to read, speak, and understand english, german or japanese * diagnosed with resectable phase ii to iiib non-small cell lung cancer (nsclc) physicians * resident of the us, germany, or japan * lung cancer-treating physician specialized in one of the following medical areas: oncology, pneumonology, thoracic surgery, or radiology * treated at least three new patients with resectable nsclc in the past year exclusion criteria: patients * appears to have sensory and/or cognitive impairment(s) that could interfere with their ability to provide online and/or verbal consent, or complete any other interview activities (based on screener judgment) * being diagnosed with another malignancy alongside nsclc * not willing to be audio-recorded during the interview physicians * appears to have sensory and/or cognitive impairment(s) that could interfere with their ability to provide online and/or verbal consent, or complete any other interview activities (based on screener judgment) * not willing to be audio-recorded during the interview

Keywords: non-small cell lung cancer (nsclc)
5 years mortality-rate in patients treated for severe pneumonia in an icu - a retrospective study

Conditions: Pneumonia

Summary: severe pneumonia has a high in-hospital mortality. there are few studies which investigate the long-term mortality in patients that are discharged alive from the hospital. in this study we want to investigate the 5 years mortality after treatment of severe pneumonia in an icu. we will also investigate the cause of death after discharge from the hospital.

patients with severe pneumonia who need treatment in an icu have a high in-hospital mortality (16-46%). there are few studies which investigate the long-term mortality (\> 1year) in patients after discharge from the hospital. there seems to be a higher mortality in this group compared to the general population. the cause(s) of this higher long-term mortality is unclear and few studies have investigated this problem. we are going to investigate the 5 years mortality rate in this population of patients. we are also going to investigate the cause of death in the patients who are discharged from the hospital alive. inclusion criteria: patients \> 18 years. primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an icu. the patients who arrive at the icu in akershus university hospital in the period from 01.01.1997 to 31.12.2006. the datas are collected from the patients' journals and the local icu register. collecting data: age, sex, comorbidity, sapsii, mechanical ventilation time, stay in the icu, stay in the hospital, icu mortality, hospital mortality, 5 years mortality, type of pneumonia (bacteriology). time of death after discharge is collected from norwegian national registry. cause of death after discharge is collected from norwegian institute of public health.

Eligibility criteria:
inclusion criteria: * patients \> 18 years. primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an icu. the patients who arrived the icu in akershus university hospital in the period from 01.01.1997 to 31.12.2006. exclusion criteria: * patients \< 18 years. patients with need for mechanical ventilation \< 24 hours

Keywords: pneumonia, mechanical ventilation, icu, mortality
rib fixation for clinically severe rib fractures from trauma

Conditions: Rib Fracture; Flail Chest

Summary: this is a multicenter randomized study investigating the differences in clinical outcomes of patients between two standard of care pathways for rib trauma: patients who receive rib fixation versus patients who receive modern critical care and pain control after sustaining clinically significant rib fractures from trauma.

this study will compare the outcomes of patients between two standard of care pathways for rib trauma: those who have their ribs plated versus those who are managed by modern critical care and pain control. a study nurse (project) coordinator will identify subjects based on inclusion and exclusion criteria, then obtain consent for each of these patients prior to randomization. randomization will be decided by a web-based computer program, accessible to the project coordinator. although this randomization occurs, the study itself is purely observational, as the intervention is currently standard of care. none of the subjects or study group members will be blinded since it is not possible to disguise the intervention. patients will be evaluated and a survey will be administered at set post-intervention intervals to determine endpoints and quality of life when data analysis will also take place.

Eligibility criteria:
inclusion criteria: * flail chest, defined as 3 or more consecutive ribs fractured in more than one place * pain and disability of an fps (functional pain scale) rating of 3 or higher * deformity and defect * non-union * thoracotomy for other indications * 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter * failure to wean from ventilator exclusion criteria: * active bacteremia * active shock * severe traumatic brain injury with gcs \< 8 * age 17 years or less or age greater than 90 years old * chronic pulmonary disease requiring home oxygenation * acute respiratory distress syndrome * penetrating chest trauma * chronic opioid dependence * fractures less than 3cm from vertebral spine

Keywords: trauma rib plate rib fixation
one day implantation program for heart failure patients implanted with crt-p

Conditions: Heart Failure

Summary: this study has been implemented to evaluate cardiac resynchronization therapy pacemaker (crt-p) implantations on a same-day basis

the objective of the study is to show in the french centers selected for the same-day organization that a same-day crt-p implantation is safe, feasible, and associated with significant cost-saving and a minimum conversion rate to full hospitalization by comparing outcomes with patients routinely hospitalized for at least one night. the medical economic evaluation will be based on the snds (national health data system) analysis.

Eligibility criteria:
inclusion criteria: * planned de novo implantation or upgrade to a cardiac resynchronization therapy pacemaker system according to the intended use * patient is able to understand the nature of the registry and has provided written informed consent for bio\|stream.hf (heart failure registry) and the registry-based trial bio\|oedipe.crt-p * patient enrolled in bio\|stream.hf (heart failure registry) exclusion criteria: * patients in emergency situation or without medical assessment before hospitalisation for implantation * patients previously implanted with an implantable cardiac defibrillator system * patients with an implantable cardiac defibrillator indication * patients planned to be implanted with an epicardial left ventricular lead (not implanted via the coronary sinus) * patients planned to be implanted with his bundle pacing system
molecular mechanisms of microrna-494 involving in cerebral ischemia

Conditions: Ischemic Stroke

Summary: we and other investigations suggested that the activation of nerve cell cycle following cerebral ischemia led to neuronal apoptosis, glial cell proliferation and the formation of glial scar.the cyclin-dependent kinases (cdks) and cyclins jointly promoted the cell cycle progression. our preliminary clinical trial found a new microrna-mir-494, which involved in the occurrence of acute ischemic stroke. in our animal experiment, mir-494 could relieve cerebral ischemia injury through inhibiting cyclin-dependent kinase 6(cdk6), ubiquitin-conjugating enzyme e2l6 (ube2l6) and histone deacetylase 3 (hdac3), which suggested that mir-494 might play an important role in the regulation of cell cycle following cerebral ischemia. this project intends to verify the following hypothesis：①mir-494 suppresses cdk6, and/or fibroblast growth factor16(fgf16)-ras-extracellular signal-regulated kinase(erk)--v-myc avian myelocytomatosis viral oncogene homolog(myc) pathway, and/or phosphatase and tensin homolog(pten)-/protein kinase b(akt)-mechanistic target of rapamycin(mtor)-s6k pathway;②mir-494 inhibits ube2l6, upregulates the hypoxia-inducible factor 1 α(hif-1α) expression in nerve cells, thereby increases the p21 and p27 protein levels and inhibits cyclin-dependent kinase2(cdk2)activity;③mir-494 represses hdac3 and downregulates the cyclin-dependent kinase1(cdk1)protein level. these all mediate the cell cycle arrest of neurons and astrocytes, reduce the neuronal apoptosis and glial scar formation,promote the recovery of neurological function and provide new targets for the treatment of ischemic stroke.


Eligibility criteria:
inclusion criteria: * (1）diagnosis of first ischemic stroke based on clinical information and magnetic resonance imaging; (2)presentation of subjects within 6h of the event; (3)national institutes of health stroke scale (nihss) score between 4 and 15. exclusion criteria: * (1）suspected cardiogenic embolism;(2）secondary stroke from cerebral hemorrhage, trauma, cancer or aneurysm and so on;(3）bleeding tendency;(4）severe cardiac,pulmonary,hepatic or renal insufficiency;(5）vital signs are unstable to be assessed.

Keywords: stroke, mir-494, neuroprotection, cdk
safety study of opc-12759 ophthalmic solution

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to assess the safety of opc-12759 ophthalmic solution in healthy subjects.


Eligibility criteria:
inclusion criteria: * bmi : {body weight (kg) / \[height (m)\] 2 } must be 17.6 or greater, and less than 26.4 kg/m2 exclusion criteria: 1. presence of ocular disorder 2. intraocular pressure of 21mmhg or higher 3. corrected visual acuity of less than 1.0 4. dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow 5. history of refractive surgery 6. history of other ocular surgeries within 12 months 7. those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose
follow up of ifn vs daas hcv svr (ifdacs study)

Conditions: Chronic Hepatitis C Infection

Summary: the study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis c virus (hcv) who received interferon-based therapy or direct-acting antiviral agents (daas)-based therapy. this long term follow up study is observational and no treatment is provided for hcv infection.


Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis c treated with interferon-based therapy or direct-acting agents (daas)-based regimen; * provide written, informed consent; * be willing and able to comply with the visit schedule and protocol-mandated procedures. exclusion criteria: * individuals planning to start a new course of hepatitis c therapy including any investigational drug or device during the course of the follow-up time frame; * history of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol. * inability to provide written informed consent.
attenuating ischemia reperfusion injury after living donor renal transplantation

Conditions: Kidney Transplantation; Renal Transplantation; Reperfusion Injury

Summary: patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. a number of lab tests will be done post-transplant to determine how well the kidney is functioning.


Eligibility criteria:
inclusion criteria: 1. must be able to provide written informed consent. 2. all recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant 3. all patients evaluated and listed with the united network for organ sharing (unos) who are eligible to receive a kidney transplant under guh's standard protocol. 4. patients between 18-80 years of age exclusion criteria: 1. recipients of multi-organ transplant 2. patients with known allergies of hypersensitivities to any of the drugs used in this protocol 3. recipients of kidneys from a deceased donor 4. recipients who are co-infected with hepatitis b, hepatitis c or hiv 5. women who are pregnant 6. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner unless they agree to avoid pregnancy throughout the duration of the trial and for 3 months following the trial.

Keywords: living donation kidney transplantation delayed graft function ischemia reperfusion injury
molecular characteristics of early-onset compared with late-onset colorectal cancer

Conditions: Colorectal Cancer; Microsatellite Instability

Summary: the distribution rate of microsatellite instability-high (msi-h) was significantly higher in early-onset colorectal cancer, and early-onset colorectal cancer has a specific mutational profile and relatively high programmed cell death ligand 1(pd-l1) expression, which may be used to guide personalized treatment to better control the disease.

the prognosis of early-onset colorectal cancer (eocrc) is worse than that of late-onset colorectal cancer (locrc), and the incidence has gradually increased in recent years, so it is necessary to study the pathogenesis and explore the target of early-onset colorectal cancer patients. in this study, investigators aimed to explore the specific molecular pathologic map of eocrc by comparing locrc. this study enrolled 11,344 patients with colorectal cancer treated at the colorectal center of the first affiliated hospital of nanjing medical university from 2003 to 2022, of whom 578 were eocrc and 10,766 were locrc. the tumor-related mutation status and tumor mutation burden (tmb) of patients were detected by next-generation sequencing technology. pd-l1 expression was detected by immunohistochemistry. the microsatellite instability was detected by polymerase chain reaction (pcr) coupled with capillary electrophoresis (2b3d nci panel) in all patients. among the 11,344 patients, 180 patients with eocrc and 90 patients with locrc patients underwent ngs investigation. compared with locrc, eocrc patients generally presented a later tnm stage, lower tumor differentiation, and poorer histological type. in locrc with msi-h stupe, tnm stage is earlier than whom with msi-l/mss. in addition, the frequency of msi-h was significantly higher in eocrc (10.2%) than locrc (2.2%). the frequency of 7-mutation panel (arid1a, fanci, casp8, dgfra, dpyd, tshr, and prkci) were relatively higher in locrc. in eocrc group, the tnm stage of msi-h subtype patients was earlier while harbored with worse tissue differentiation and higher proportion of mucinous adenocarcinoma. besides, among the eocrc patients, fbxw7, fat1, atm, arid1a and kmt2b mutation frequencies were significantly increased in patients with msi-h type. comparing with msi-h patients of locrc, the eocrc patients with msi-h presented a higher mutation frequencies of fgfbr2, pbrm1, rnf43, lrp1b, fbxw7, atm and arid1a. in addition, eocrc patients were identified with higher tumor mutation burden, especially in the msi-h type. pd-l1 expression calculated by tumor proportion score (tps) was also elevated in eocrc and correlated with msi status.

Eligibility criteria:
inclusion criteria: * men and women aged 18-75 years old; * histologically proven colon or rectal adenocarcinoma. exclusion criteria: * patients over 80 years of age; * recurrent colorectal cancer; * multiple primary tumors.