Kornimate/medical-research-clean huggingface dataset:
a 24-week study evaluating the effectiveness and safety of lucentis® 0.2mg in retinopathy of prematurity participants in china

Conditions: Retinopathy of Prematurity

Summary: this is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the treatment of retinopathy of prematurity (rop) participants in a real world clinical setting in mainland china.

eligible participants treated according to local routine clinical practice will be enrolled in the study upon signing an informed consent. participants will enter the study when they receive their first treatment and are followed up for 24 weeks. during the follow up period, participants could receive post-baseline treatment (i.e., ranibizumab or laser therapy) patients will be treated according to the approved label and standard of care and as per investigator judgement. end of study will be defined as completion of the week 24 visit or premature withdrawal visit

Eligibility criteria:
inclusion criteria: 1. signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements 2. male or female preterm infants with a birth weight of less than 1500 g 3. bilateral rop with 1 of the following retinal findings in each eye: * zone i, stage 1+, 2+, 3 or 3+ disease, or * zone ii, stage 3+ disease, or * a-rop exclusion criteria: 1. have a history of hypersensitivity (either the patient or the mother) to ranibizumab or any component of the ranibizumab formulation or to drugs of similar chemical classes 2. have been previously exposed to any intravitreal or systemic anti-vegf agent (either the patient or the mother during this child's pregnancy) 3. have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer 4. have received any previous surgical or nonsurgical treatment for rop (e.g., ablative laser therapy or cryotherapy, vitrectomy) 5. participants who have contraindications according to locally approved ranibizumab label

Keywords: retinopathy of prematurity rop nis china ranibizumab
the northern-european initiative on colorectal cancer

Conditions: Colorectal Cancer

Summary: colorectal cancer (crc) is a major burden in western countries. the disease develops from precursor lesions during a long time-interval. colonoscopy can detect and remove crc precursor lesions and may thus be effective for crc prevention. many national and international health organisations demand evidence from randomised trials to reduce incidence or mortality of the target disease before advocating population-wide cancer screening. however, while colonoscopy screening for the prevention of colorectal cancer is established in the united states and several european countries, no randomised trials exist to quantify the possible benefit of colonoscopy screening. nordicc is a randomised trial investigating the effect of colonoscopy on crc incidence and mortality. nordicc is a multicentre, randomised trial in nordic countries, the netherlands and poland. a minimum of 66 000 individuals, age 55-64 years, are drawn randomly from the population registries in the participating countries. 22 000 are invited for once-only colonoscopy (2:1 randomisation). expected work-load with 50% compliance will be 11,000 colonoscopies. at the screening examination, all detected lesions are biopsied and removed whenever possible. the remaining 44 000 individuals (control group) are not offered any screening examination (care as usual).the primary study aims are crc incidence and crc mortality after 15 years of follow-up, with an interim analysis after 10 years of follow-up. in an intention-to-treat approach, a risk reduction of crc mortality of 25% in the colonoscopy screening group compared to the control group is expected after 10 years follow-up, estimating 50% compliance in the screening group.


Eligibility criteria:
inclusion criteria: * this study is a population-based randomised controlled trial, with randomisation of individuals age 55-64 years living in the screening areas directly from the population registries to either screening group or control group. eligible persons with the same home address will be randomised to the same group (household randomisation). exclusion criteria: * individuals with previous colorectal surgery (resections, enterostomies) * individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation). * on-going cytotoxic treatment or radiotherapy for malignant disease * severe chronic (longer than trial duration) cardiac (nyha iii-iv)or lung disease * lifelong anticoagulant therapy with warfarin * a coronary event requiring hospitalization during the last 3 months * a cerebrovascular event during the last 3 months * resident abroad * return of unopened letter of invitation and/or reminder (address unknown) * message from neighbour/family/post office on death of screenee (not updated in population registry)
exploring the role of 3t mri in gamma knife radiosurgery

Conditions: Brain Metastases

Summary: gamma knife radiosurgery is a non-invasive technique for the delivery of a single, high dose of radiation to an intra-cranial target. mri has an established and central role in the treatment planning process and assessment of response to intracranial radiosurgery. increasing the field strength of mri from 1.5t to 3t promises to improve the signal, and in turn the quality of images. however, the technology also introduces new limitations, and the role and safety of 3t mri in the management of patients receiving radiosurgery has not yet been reported. in this pilot study, we will explore the spatial integrity, and incremental image-guidance utility of 3t mri in patients receiving radiosurgery. the preliminary data acquired in this study will be instrumental to the judicious design and conduct of subsequent definitive clinical trials. up to fifty patients will be enrolled in this study.


Eligibility criteria:
inclusion criteria: * patients planned to receive gamma knife radiosurgery will be eligible for enrollment on this study. exclusion criteria: * age\<18 * contra-indications to 3t mri, such as implanted metal devices or shrapnel.

Keywords: 3t mri gamma knife radiosurgery
effect of vitamin k 2 on vascular calcification in hemodialysis patients

Conditions: End Stage Renal Disease

Summary: the aim of this study is to assess the effect of supplementation of vitamin k2 (menaquinone, mk-7) and cholecalciferol (inactive vitamin d) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.

vascular calcification occurs in more than half of chronic renal failure patients, which mainly appears in the large and medium size arteries \[3, 4\]. it seems that vas¬cular calcification is caused by dynamic imbal-ance of intravascular calcium and phosphorus. however, more and more studies pointed out that vascular calcification were related with local cell's function and biological characteris¬tics. the aim of this study is to assess the effect of supplementation of vitamin k2 (menaquinone, mk-7) and cholecalciferol (inactive vitamin d) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.

Eligibility criteria:
inclusion criteria: * patients aged 6-18 years * patients on hemodialysis since 3 months or longer * hemodialysis frequency 3 times or more weekly exclusion criteria: * patients with life expectancy \< 3 months * patients taking warfarin * patients with known intestinal malabsorption

Keywords: hemodialysis and vitamin k2
central sensitization in patients seeking outpatient physical therapy services

Conditions: Low Back Pain; Knee Osteoarthritis; Neck Pain

Summary: this is an observational study to examine presence of cs in patients with knee osteoarthritis (oa), chronic lbp (clbp), and chronic neck pain (cnp) seeking outpatient physical therapy (pt) services. the study will also examine if outcomes differ between patients with cs and patients without cs symptoms with standard pt interventions.

central sensitization (cs), defined as augmented pain processing, is common in subgroup of nearly all chronic pain conditions, including fibromyalgia, clbp, oa, and chronic tension headache. however, current studies of cs are primarily limited to research settings, lacking the knowledge about prevalence of cs and rehabilitation outcomes in usual clinical care. practicing clinicians do not routinely assess for cs symptoms. without proper screening for cs, and lack of knowledge of varying levels of nervous system involvement contributing to pain, clinicians are unable to fully identify the depth of the mechanisms and therefore unable to fully determine the best treatment strategies. this observational study addresses this gap in knowledge by screening patients for cs symptoms.

Eligibility criteria:
inclusion criteria: * diagnosis of knee, neck, or back pain * chronic pain as defined pain \> 3 months * able to read and understand english exclusion criteria: * pregnancy * pain less than 3 months
establishment of multimodal-multiparametric progressive prediction models for thyroid associated ophthalmopathy

Conditions: Thyroid-Associated Ophthalmopathy

Summary: thyroid-associated ophthalmopathy (tao) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (graves disease, gd). the clinical manifestations of tao are complex and varied. in severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. therefore, a reasonable and effective treatment plan should be chosen according to the degree of tao. the aim of this clinical study is to: 1. found characteristic changes from baseline to the end of treatment. 2. identify characteristic changes associated with treatment response. 3. construct a multimodal and multiparameter prediction model by characteristic changes.


Eligibility criteria:
inclusion criteria: * according to the bartley criteria，diagnosed tao at our hospital from 2017/1/1 to 2024/3/31 * moderate to severe patients defined by eugogo * cas ≥4 (on the 7-item scale) for the study eye * completed orbital mri at our hospital * received complete medical treatment and completed assessment at our hospital exclusion criteria: * anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision * history of systemic (eg, oral or iv) steroid use with a cumulative dose equivalent to \&gt;1 g of methylprednisolone for the treatment of tao. * any major illness/condition or evidence of an unstable clinical condition that, in the investigator\&#39;s judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study * any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant\&#39;s participation in the study * pregnant or lactating * any other condition that,would impair the ability of the participant to undergo orbital mri
screen smart: using digital health to improve hiv screening and prevention

Conditions: HIV Infections

Summary: the goal of this interrupted time series quasi-experimental design study is to implement universal opt- out hiv testing and linkage to hiv preventive care in 15-21 year old adolescents visiting the pediatric emergency department (ed). the main question\[s\] it aims to answer are: 1. what is the uptake, reach and effectiveness of universally offered, opt-out hiv screening across pediatric eds after implementing an adapted version of a tablet-based screening process? 2. what is the successful linkage to comprehensive hiv pre-exposure prophylaxis (prep) care using a novel, digital health platform? participants will 1. complete the previously developed and validated computerized sexual health screen (cshs) containing questions regarding their personal sexual health history 2. have the opportunity to opt-out of clinician-ordered hiv testing 3. patients meeting cdc criteria for hiv prep will be given the opportunity to enroll in the digital health prep linkage platform and followed for 3 months after enrollment.

using a previously developed tablet-based, broad scale gonorrhea and chlamydia screening process, the investigators will adapt, refine, and test this process with the aim of increasing universally offered, opt-out hiv screening in the pediatric ed through electronic integration of patient reported data for provision of clinical decision support for hiv screening and identification of prep candidacy. the investigators will then use mhealth to link patients to prep services. the goal of this study is to (1) adapt, refine, and test this previously implemented multi-center, ed-based, screening study with a goal of increasing universally offered, opt-out hiv screening among adolescents in the pediatric ed and (2) link at-risk adolescents to prep services and preventive care. this will be accomplished through a network of children's hospital eds (pediatric emergency care applied research network or pecarn). this research will contribute to the evidence base for creating clinically effective and sustainable hiv screening programs that can be successfully implemented into the clinical workflow of the ed. it will also improve identification and linkage to prep care for at risk adolescents using mhealth strategies by first identifying adolescents and young adults (aya) who are prep candidates based on their responses to a computerized sexual health screen (cshs) and subsequently (1) providing clinical decision support to providers via the electronic health record and (2) direct text messaging from the cshs to prep candidates providing educational content and connecting youth to a prep navigator. this intervention will rely on an innovative approach that electronically integrates patient-reported data to guide clinical decision support.

Eligibility criteria:
inclusion criteria: * all patients 15-21 years of age visiting a pediatric emergency department. exclusion criteria: * unable to understand english * critically ill * cognitively impaired * altered mental status

Keywords: hiv adolescents emergency department mhealth preventive care
role of circulating tumour dna testing in assessing for alterations of primary anti-egfr resistance in ras/raf wild-type metastatic colorectal cancer patients

Conditions: Colorectal Cancer

Summary: the study aims to explore the clinical utility of circulating tumour dna (ctdna) in assessing for alterations of anti-epidermal growth factor receptor (egfr) primary resistance in ras and braf wild-type metastatic colorectal cancer (crc) patients treated with anti-egfr monoclonal antibodies (cetuximab / panitumumab) in combination with fluorouracil (fu)-doublet chemotherapy.

a single blood sample (20ml) will be collected after the patient has given informed consent. the blood sample will be collected within 4 weeks prior to the patient starting chemotherapy. blood samples collected will be processed in accordance with the guardant360 clinical blood collection kit instructions (guardant health, inc.). patient outcomes with respect to response rate, progression-free survival, overall survival, toxicities and other co-morbid conditions will be ascertained by medical record review conducted by the study personnel. prospective clinical data that will be collected include: patient demographics, tumor stage and pathological tumor characteristics at diagnosis, laboratory data at diagnosis and serial pre-specified time points, imaging outcomes, chemotherapy information, date of recurrence, and date and cause of death. although the data will be censored at the study end-points, the patient's medical record will be reviewed indefinitely to follow the health outcomes.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed stage iv colon or rectal cancer who are ras/braf wild-type by routine tumor profiling and who are beginning standard-of-care treatment with fluorouracil-based doublet chemotherapy in combination with anti-egfr monoclonal antibodies. prior treatment with adjuvant therapy is allowed if completed more than 6 months prior to relapse of disease. exclusion criteria: * pregnant women will be excluded from the study. * patient unable to give informed consent will be excluded from the study. * patients who have previously received chemotherapy in the metastatic setting. * patients who have previously received adjuvant chemotherapy less than 6 months prior to relapse of metastatic disease.

Keywords: ctdna anti_egfr ras/raf wild-type metastatic colorectal cancer
pharmacokinetics of teicoplanin in intensive care and haematology patients

Conditions: Bacterial Infections

Summary: characterize teicoplanin pk in critically ill patients with a specific focus on alterations of exposure due to variability in renal function. in a prospective, observational, open-label study the investigators aim to define pk of free drug concentrations of teicoplanine in icu and heamatology patients and define a pk model for bayesian dose individualization.

bacterial infection with coagulase-negative staphylococci (cns) or methicillin resistant and sensitive staphylococcus aureus(mrsa/mssa) indicates poor prognosis and increased mortality in critically ill patients. with the current emergence of glycopeptide-intermediate sensitive staphylococcus aureus strains, personalized dosing of teicoplanin is of utmost importance to preserve the current therapeutic armamentarium. teicoplanin is considered equipotent to vancomycin, albeit safer with minimal nephrotoxicity. it is estimated that 50% of all critically ill patients treated with teicoplanin does not reach target exposure. this is the major driver for treatment failure and development of resistance and dose individualization will overcome this problem. our project is aimed at developing and implementing a personalized dosing strategy for teicoplanin, to prevent development of glycopeptide resistance and allow safe treatment of glycopeptide intermediate sensitive bacteria. in a prospective clinical study, critically ill patients (defined as icu and hematology patients) who receive teicoplanin as standard care for antimicrobial treatment will be eligible for inclusion. minimally invasive blood sampling for pharmacokinetic analysis will be retrieved through an indwelling central venous catheter or an arterial line (9 samples per patient). teicoplanin total and free drug concentrations will be measured using a validated analytical assay. a total of 30 patients will be included. we will develop a population pk model using nonlinear mixed effects modelling for total and unbound teicoplanin to characterize the magnitude of inter-individual variability in pk parameters (clearance, distribution volume), and to identify patient-derived characteristics that can predict such variability in a critically ill patient population.

Eligibility criteria:
inclusion criteria: 1. the patient is admitted to the icu of the haematology department 2. the patient is at least 18 years of age on the day of inclusion 3. is managed with a central venous catheter or arterial line 4. is treated with teicoplanin as a part of standard care exclusion criteria: 1. has previously participated in this study 2. patient is admitted to the haematology department and receives any form of rrt other than continuous venovenous hemofiltration (cvvh).

Keywords: teicoplanin pharmacokinetics critically ill
does probiotic supplementation prevent kidney injury during strenuous physical exercise?

Conditions: Heat Stress; Kidney Injury

Summary: severe heat strain arising from intense physical work under climate conditions that does not allow sufficient heat dissipation may lead to heat stroke. this severe conditions is hypothesized to be secondary to increased gut permeability and leakage of bacterial toxins across the gut membrane, stimulating a systematic inflammatory response and associated organ injury. repeated such sub-clinical increases in gut permeability has been suggested to contribute to the high burden of chronic kidney disease among heat-stressed workers. many marathon runners experience a transient increase in kidney injury biomarkers while running. probiotics have been studied as a way to decrease gut permeability and reduce systemic inflammation in many settings, including in athletes . however, no study has measured renal outcomes among workers or athletes performing strenuous activity. this is of interest as it could test the hypothesis that gut-induced inflammation is a driver of kidney injury during heat stress, and could point to a possible intervention to add on to efforts to relieve heat strain. in the present study, recreational or professional runners will be randomized to take a probiotic supplement or placebo during a 4 week period preceding a strenuous physical exercise (minimum 21 km run). urine samples will be taken before and after the run, and analyzed for markers of renal injury and inflammation.

participants registered to run in organised half-marathons, marathons and ultramarathons in southern sweden will be recruited. they will be asked to abstain from probiotic supplementation (including functional foods with probiotics) for 2 weeks, and then commence a 4-week period of probiotic or placebo supplementation. at the end of the 4 week treatment period, the participants run the race. urine samples are taken before and after the race and analysed for kidney injury markers. stool samples are taken by participants at the initiation of the treatment period, last stool before the race, and first stool after the race.

Eligibility criteria:
inclusion criteria: * planning to run one of the long-distance races included. exclusion criteria: * not having run at least 21 km previously, * smoking, * living too far away from the study area, * unwilling to abstain from probiotic supplementation during treatment period, * unwilling to abstain from nsaids or gut-permeability lowering supplements before the run, * regular use of prescribed drugs (including hormonal contraceptives).

Keywords: heat stress probiotic kidney injury gut permeability