Kornimate/medical-research-clean huggingface dataset:
understanding the relationship between infliximab levels to clinical response of remicade in crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to improve the investigators understanding of the relationship between crohn's disease and blood levels of the drug infliximab (remicade). the investigators want to determine whether measuring drug levels can be helpful in understanding how patients respond to this treatment.

the efficacy of infliximab to maintain remission in crohn's disease has been confirmed by randomized, controlled trials, however the utility of serum infliximab and ati titers is less clearly described in the clinical practice setting to manage dose and interval levels. the primary objective of this study is to evaluate the clinical responsiveness of active (hbi \>10) crohn's disease to infliximab as it relates to serum infliximab levels. though the assay for an infliximab level is commercially available, current dosing practices rely on the assessment of clinical data (laboratory data, symptoms, colonoscopy, etc). in order to understand this relationship, serum infliximab and ati titers will be collected over the course of 8 (approximately 1 year) infusions. the results of these levels will be retrospectively correlated to the patient's clinical response to treatment. the secondary objective is to identify predictors of poor response to infliximab by evaluating the efficacy of a dose escalation strategy in patients classified as primary or secondary non-responders. understanding the association of serum infliximab levels to disease response may be a useful objective tool to optimize and individualize dosing amount and frequency especially in patients with incomplete or loss of response to therapy.

Eligibility criteria:
inclusion criteria: * patients with active (hbi \>10) refractory inflammatory and/or perianal fistulizing crohn's disease who are prescribed infliximab as standard of care by their gastroenterologist. exclusion criteria: * pregnant women.

Keywords: crohn's disease remicade infliximab
efficacy and safety of elgn-2112 on intestinal malabsorption in preterm infants

Conditions: Intestinal Malabsorption

Summary: the study will evaluate the effect of elgn-2112 on intestinal malabsorption in preterm infants.


Eligibility criteria:
inclusion criteria: * male or female pre-term infant 26 and up to 32 weeks gestation. gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound * birth weight ≥ 500g * singleton or twin birth exclusion criteria: -
sentinel(tm) post-market registry

Conditions: Transcatheter Aortic Valve Replacement; Severe Symptomatic Calcified Native Aortic Valve Stenosis

Summary: the sentinel post-market registry is a prospective, multi-center, registry using the ce-marked sentinel system in subjects with severe symptomatic calcified native aortic valve stenosis indicated for tavr. subjects enrolled in the registry will undergo tavr + sentinel. basic demographic information and detailed procedural data will be captured and documented in a registry case report form. all sentinel filters will be sent for histopathology at an independent core-lab.


Eligibility criteria:
inclusion criteria: 1. approved indications for commercially available ce-marked tavr devices. 2. compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (\> 70%). 3. the subject or the subject's legal representative has been informed of the nature of the registry, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective site. exclusion criteria: 1. vasculature in the right extremity precluding 6fr sheath radial/brachial access 2. inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse 3. hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature 4. patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion 5. excessive tortuosity in the right radial/brachial/subclavian artery preventing sentinel device access and insertion 6. patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium 7. currently participating in an investigational drug or investigational (non ce-mark) device study

Keywords: selected for tavr by heart team consensus treated with ce-marked tavr devices
automated segmentation and volumetry for meningioma using deep learning

Conditions: Meningioma; Artificial Intelligence

Summary: u-net-based architectures will be applied to 500 contrast-enhanced axial mr images of different patients from a single institution after manual segmentation of meningioma, of which 50 were used for testing. tumor volumetry after autosegmentation by trained u-net-based architecture is final goal.

u-net-based architectures will be applied to 500 contrast-enhanced axial mr images of different patients from a single institution after manual segmentation of meningioma, of which 50 were used for testing. after preprocessing with z-isotropification and intensity normalization of images, 3 u-net-based networks (2d u-net, attention u-net, 3d u-net) and 3 nnu-net-based networks (2d nnu-net, attention nnu-net, 3d nnu-net) will be trained with meningioma-segmented images. for applying to 3d networks, sagittal and coronal images will be reconstructed using axial images. after prediction, the cut-off of the probability function, which is a trade-off, will be obtained with the gaussian mixture modeling algorithm using the probability density function. the voxels having a probability function higher than that will be finally predicted as meningioma. tumor volume is calculated as the sum of the product of segmented area and thickness of axial images. for performance evaluation, dice similarity coefficient (dsc), precision, and recall will be evaluated compared with manually segmented voxels for validation datasets. the results of volumetry of each model will be compared with manual segmentation-based volume through pearson's correlation analysis.

Eligibility criteria:
inclusion criteria: * radiologically diagnosed meningioma by mri exclusion criteria: * under 18 years old * multiple meningiomas * orbital meningioma * any prior treatment for intracranial meningioma before registration

Keywords: meningioma artificial intelligence autosegmentation volumetry
an observational cohort trial of outcomes and antibody responses following treatment with covid19 convalescent plasma in hospitalized covid-19 patients

Conditions: Covid19

Summary: this is an observational study designed to learn more about how covid19 convalescent plasma works in patients with covid19 compared to those patients who did not receive convalescent plasma treatment. information about patient recovery will be collected from participants' electronic medical records to evaluate safety, clinical outcomes, and sars-cov2 antibody responses in patients who were treated with convalescent plasma under a separate expanded access protocol, nct04372368.

this a prospective, observational cohort trial to evaluate safety, clinical outcomes, and sars-cov2 antibody responses in patients who were treated with anti-sars-cov-2 convalescent plasma under expanded access protocol, nct04372368. hospitalized patients with acute respiratory symptoms with or without confirmed interstitial covid-19 pneumonia will be enrolled. the investigators anticipate that a minimum of 150 eligible subjects will be enrolled to receive covid19 convalescent plasma over the 12 month period for the fda ind expanded access protocol, nct04372368, to provide covid19 convalescent serum, which is a separate treatment trial. this observational protocol will co-enroll patients in parallel with the expanded access protocol and expects to enroll approximately the same number of patients but no treatment will be provided as part of this protocol. additionally, the investigators will use compass data with identifiers to pull information on hospitalized control covid19+ patients from hospital admission date 4/20 to current for comparison. this protocol is limited to data collection using the emr to evaluate outcomes following covid19 convalescent plasma treatment. patient-linked specimens will not be obtained and analyzed outside of the expanded access protocol for distribution of covid19 convalescent plasma. for this protocol, only de-identified, discarded samples may be obtained during routine patient care. thus, consent will only be obtained from patients/subjects for participation in data abstraction/analysis from the electronic medical record.

Eligibility criteria:
inclusion criteria: * age 18 years or older * hospitalized with covid-19 respiratory symptoms and confirmation via covid-19 sars-cov-2 rt-pcr testing. * patient treated with covid19 convalescent plasma. * patient or surrogate designated decision maker is willing and able to provide written informed consent. exclusion criteria: * receipt of pooled immunoglobulin in past 30 days * contraindication to transfusion or history of prior reactions to transfusion blood products

Keywords: covid-19 coronavirus sars-cov-2 convalescent plasma
lung cancer screening program in mexico

Conditions: Lung Cancer

Summary: this prospective study aims to detect early-stage lung cancer using low-dose computed tomography (ldct) in mexicans aged 50 or older who are current or former heavy smokers, non-smokers exposed to significant wood smoke, or diagnosed with copd. annual ldct, spirometry, and serum biomarker tests will be conducted over 3 years, and a follow-up lasting up to 10 years.

this prospective cohort study aims to detect lung cancer in early stages using ldct scans in mexican individuals aged 50 years or older. eligible participants comprise current smokers with a history of ≥ 20 pack-years, former smokers who have quit within the past 15 years, non-smokers exposed to wood smoke more than 100 hours/year, or patients diagnosed with chronic obstructive pulmonary disease (copd). secondary objectives include assessing the 10-year mortality rate, the association of lung cancer with immunologic biomarkers, the demographic characterization of participants, the psychological impact of an lc screening program, the histological profiling of positive cases, lung function changes in at-risk individuals, and the clinical staging distribution at diagnosis. the study will conduct annual ldct scans, lung function tests (spirometry), anxiety and depression assessments, and serum biomarkers tests over 3 years. positive ldct results will adhere to lung-rads guidelines and be managed by a multidisciplinary team. prevention strategies, including tobacco cessation treatments, will be provided. follow-up will continue for 5 and 10 years or until an event of completion occurs (cancer diagnosis, end of follow-up, or death).

Eligibility criteria:
inclusion criteria: eligible participants over fifty years old and one of the next criteria: * current smokers (\>20 pack-years) * former smokers (\>20 pack-years) who have quit within the past 15 years, * non-smokers exposed to wood smoke more than 100 hours/year * patients diagnosed with chronic obstructive pulmonary disease (copd). exclusion criteria: * subjects who cannot be examined by tomography due to physical limitations such as weight. * history of any type of cancer within the last five years, except non-melanoma skin cancer. * symptoms consistent with some malignant neoplasm. * people with a poor physical-emotional condition that reduces their life expectancy or does not ensure adherence to the study. elimination criteria • withdrawal of informed consent

Keywords: lung cancer screening early detection lung cancer low-dose ct high-risk population
two schedules of hepatitis b vaccination in predialysis chronic renal failure patients

Conditions: Renal Failure

Summary: patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled and this could improve seroconversion rate of hepatitis b vaccination. in this study, the investigators aimed to compare seroconversion rates and immune response rates using four doses of 40 μg and three doses of 20 μg of euvax b recombinant hepatitis b surface antigen (hbsag) vaccine given to predialysis ckd patients.

in an open, randomized clinical trial, the investigators compared seroconversion rates in 51 predialysis patients with mild and moderate chronic renal failure using either 40 μg 4 doses or 20 μg 3 doses of euvax b recombinant hepatitis b vaccine administered at 0, 1, 2, 6 and 0, 1, 6 months respectively.

Eligibility criteria:
inclusion criteria: * predialysis patients, * \> 18 years with mild and moderate chronic renal failure, * serum creatinine between 1.5-6 mg/dl exclusion criteria: * patients with severe renal failure, * serum creatinine \> 6 mg/dl, * requiring dialysis or expected to require dialysis within 1 year, * receiving immunosuppressive treatment, * known lymphoproliferative disorder.

Keywords: predialysed chronic renal failure patients
study of human anti-tnf monoclonal antibody d2e7 in subjects with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to evaluate safety by collecting serious adverse events in subjects with moderately to severely active rheumatoid arthritis who are unable to obtain etanercept and who have failed one or more prior disease-modifying antirheumatic drugs (dmards).


Eligibility criteria:
inclusion: * subjects must meet acr criteria for diagnosis of ra for at least 3 months, must meet acr functional class i, ii or iii (1992 criteria) and must have a confirmed diagnosis of active moderate to severe rheumatoid arthritis as defined by 6 or more swollen joints and 9 or more tender joints; * must also have das of 3.2 or greater at study entry, * normal laboratory parameters and esr \>20, * satisfactory response or intolerance to one or more prior dmards and * be willing and able to give informed consent. exclusion: * previous treatment with total lymphoid irradiation or anti-cd4 or campath 1h monoclonal antibodies resulting in persistent cd4 lymphopenia, * history of acute inflammatory joint disease other than ra, * prior treatment with cyclophosphamide or chlorambucil, * prior treatment with intravenous immunoglobulin within 70 days, * history of malignant lymphoma, * history of uncontrolled diabetes, * unstable ischemic heart disease, * active inflammatory bowel disease, * active peptic ulcer disease or stroke, * positive hiv status, * positive serology for hepatitis b or c, * no previous history of tuberculosis or listeria infection, * no previous history of cancer other than successfully treated skin cancer; * women can not be pregnant or be breastfeeding
intradural disc herniation: a case report and review of complications

Conditions: Disc Herniation

Summary: this observational study collects clinical data as well as pathological reports from a patient with an intradural disc herniation, reports on the course of the patient's recovery through surgical treatment, summarizes the complications of this type of disease, and provides new ideas for improving the chances of preoperative diagnosis.

we collect the patient's personal history, family history, reason for visit, visit flow, clinical data, pathology reports, and surgical images and videos.

Eligibility criteria:
inclusion criteria: * idh patients exclusion criteria: * no

Keywords: intradural disc herniation complications degenerative spinal disease decompression
aqueous humor level of cytokines in polypoidal choroidal vasculopathy and change of cytokines after photodynamic therapy

Conditions: Polypoidal Choroidal Vasculopathy

Summary: this is a prospective, comparative control analysis. the investigators want to evaluate the aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic therapy and lucentis (ranibizumab)on the level of vascular endothelial growth factor.

to compare the effect of combination therapy of intravitreal injection of lucentis™ and photodynamic therapy versus only photodynamic therapy on aqueous humor vascular endothelial growth factor level in polypoidal choroidal vasculopathy patients to establish the vascular endothelial growth factor expression after photodynamic therapy and the direct effect of lucentis™ on this increased vascular endothelial growth factor level. additionally the investigators want to examine the vascular endothelial growth factor , tumor necrosis factor alpha, interleukin-2, interleukin-6 and interleukin-8 level of aqueous humor in symptomatic, active polypoidal choroidal vasculopathy patients.

Eligibility criteria:
\ inclusion criteria: * male or female patients ≥ 45yrs of age * best corrected visual acuity 20/30 to 20/320 snellen equivalent using etdrs chart measured at 4 meters * signed written informed consent * evidence of polypoidal choroidal vasculopathy , active in disease activity. * presence of subfoveal, juxtafoveal or extrafoveal active characteristic macular polypoidal lesions on indocyanine green angiography * confirmed to be active in disease activity by fluorescein angiography * the total lesion must have the greatest linear dimension less than 5400 microns ( \~9 mps disc areas ) as delineated by indocyanine green angiography * had not been treated in the past * patients willing and able to comply with all study procedures exclusion criteria: * previous history of laser photocoagulation,photodynamic therapy,anti vegf therapy, submacular surgery in the study eye * have known hypersensitivity to visudyne® and lucentis™ * previous treatment with external-beam radiation therapy or transpupillary thermotherapy * history of vitrectomy * intraocular surgery,yttrium aluminum garnet(yag) laser\< 1month before day 0 * additional eye disease that could compromise visual acuity * ocular inflammation * vitreous hemorrhage * uncontrolled glaucoma * current use or of likely need for systemic medications known to be toxic to the eye. * inability to obtain fluorescein angiography and indocyanine green angiography, due to media opacity, allergy to the dye or lack of venous access * are participating in another clinical study. * disciform scar * mental illness that precludes the patient from giving informed consent * patients who are considered potentially unreliable \ -age matched patients with cataract without other ocular diseases such as glaucoma, high myopia, ocular ischemic diseases, retinal disease, or with systemic diseases like diabetes mellitus.

Keywords: vegf (vascular endothelial growth factor)
a study of prt-201 administered after arteriovenous graft (avg) creation in patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: prt-201 is a recombinant human type-i pancreatic elastase intended for local, long-lasting dilation of the avg venous anastomosis and outflow vein. the goal of the treatment is to improve primary patency and long-term survival of avgs and thereby provide patients with chronic kidney disease (ckd) a reliable and durable vascular access site for hemodialysis. recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. this clinical trial will explore the safety and dilatory effect of topically administered prt-201 on the outflow vein of a newly placed upper extremity avg.


Eligibility criteria:
inclusion criteria: 1. age of at least 18 years. 2. chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence. 3. planned creation of a new upper extremity avg or "jump" graft exclusion criteria: 1. patients for whom this is the only potential site for an upper extremity vascular access. 2. creation of a new avg or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent. 3. on physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion. 4. history or presence of an arterial aneurysm. 5. previous treatment with prt-201.

Keywords: chronic kidney disease arteriovenous grafts (avg) hemodialysis vascular access dialysis graft access vonapanitase kidney renal
effectiveness of integrated care on delaying chronic kidney disease progression in rural communities of thailand

Conditions: Chronic Kidney Disease

Summary: if primary health-care officers and villages health volunteers (vhvs) be trained to render proper ckd care, it is interesting if their intimate relationship and commitment to their responsible village households will result in better outcomes when compared with the conventional care model as mention above. in this project, we plan to compare the effectiveness of a conventional care program against an integrated multidisciplinary ckd care program provided by nephrologists in conjunction with well-trained paramedical personnel and vhvs on ckd progression.

background the unique characteristic of community-health care in thailand is a system of primary- health care officers and village health volunteers (vhvs) providing basic health care to more than 90% of thai population. should these allied personnel be trained on how to render proper chronic kidney disease (ckd) care, it would be interesting to study whether their role play care will result in better quality of ckd care. design this study is a community-based cluster randomized controlled trial to be conducted in 2 districts of kamphaeng phet province, located about 400 kilometers north of bangkok. about 300 stage 3-4 ckd patients will be enrolled to each of the 2 treatment groups. patients in both groups will be treated according to the national kidney foundation kidney disease outcomes quality initiative guidelines. the district 1 (control group) patients will be provided a conventional ckd care. for the district 2 (intervention group) patients, an integrated ckd care program will be provided by the multidisciplinary team of district hospital in conjunction with the community ckd care networks (i.e. primary-health care officers and vhvs). the key activities of integrated ckd care program are live demonstration about treatment and optimal diets for ckd patients which will be provided during each hospital visit and quarterly home visits. clinical and laboratory parameters of all cases will be assessed every 3 months. duration of the study is 24 months. the primary outcome of this study is the rate of egfr decline. the secondary outcomes are time of initiation of dialysis, cardiovascular mortality, and all-cause mortality.

Eligibility criteria:
inclusion criteria: * ages 18-70 years and known to have diabetes and/or hypertension. * egfr are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months. exclusion criteria: * unstable/advanced cardiovascular disease * active glomerular disease, obstructive uropathy, end-stage renal disease, hiv infection, pregnancy, body mass index (bmi) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells \>3 cells/high power field or urine white blood cells \>10 cells/high power field).

Keywords: chronic kidney disease integrated chronic kidney disease care village health volunteers