Kornimate/medical-research-clean huggingface dataset:
serum ipth, calcium and phosphate, and the risk of mortality in beijing elderly hemodialysis population

Conditions: End Stage Renal Disease

Summary: incidence of end stage renal disease (esrd) amongst elderly patient group is continuously increasing with population aging progressing. mineral and bone disorder (mbd) is a common complication caused by esrd, it raises the incidence of cardiovascular disease (cvd) in hemodialysis patients, as well as mortality. joint effects of kidney failure and aging on elderly hemodialysis patients make the contribution factors of ckd-mbd quite complex, and it also leads to differences in clinic manifestation between elderly hemodialysis patients and non-elderly hemodialysis patients. since not much studies had been done for this specific subject, thus, research on elderly patients who is taking maintenance hemodialysis is very necessary. this study is a retrospective research to identify optimized target value of calcium and phosphorus for elderly patients taking maintenance hemodialysis and hence provide guidance for clinical practices. the data for this study will be provided by beijing blood purification quality control and improvement center. clinical files and calcium and phosphorus metabolic indices will be collected amongst elderly patients who were elder than 65 years and was taking maintenance hemodialysis between jan 1st, 2012 through dec 31st, 2016. relationship between calcium level, phosphorus level, ipth index, all-cause mortality and cvd caused mortality will be analyzed to identify optimized range of target calcium levels, phosphorus level for hemodialysis treatment


Eligibility criteria:
inclusion criteria: * the data shall include the information of elderly hemodialysis patients who were 65 years or elder between jan 1st, 2012 and dec 31st, 2016 exclusion criteria: * the patients who only has less than 6 months history of hemodialysis since selected in the research patient group the patients who passed away within 3 months since selected in the research patient group the patients who took less than 3 hemodialysis in a week the patients who took kidney transplant during the research time period the patients who do not have blood biochemical results in the records

Keywords: serum ipth calcium phosphate
a study, comparing ruxolitinib topical cream 1.5% (taro pharmaceuticals u.s.a, inc.) to opzelura (ruxolitinib) cream for the treatment of mild-to-moderate atopic dermatitis.

Conditions: Atopic Dermatitis

Summary: to demonstrate the therapeutic equivalence and safety of ruxolitinib topical cream 1.5% (taro pharmaceuticals u.s.a, inc.) and opzelura (ruxolitinib) cream in the treatment of mild-to-moderate atopic dermatitis

a multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing ruxolitinib topical cream 1.5% (taro pharmaceuticals u.s.a, inc.) to opzelura (ruxolitinib) cream and both active treatments to a placebo control in the treatment of mild-to-moderate atopic dermatitis.

Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant female aged ≥ 12 years * subjects who are 18 years of age or older must have provided irb approved written informed consent. subjects 12 to 17 years of age, inclusive, must have provided irb approved written assent; this written assent must be accompanied by an irb approved written informed consent from the subject's legally acceptable representative (i.e., parent or guardian). * subjects who have a clinical diagnosis of ad as defined by the criteria of hanifin and rajka. * subjects who have a clinical diagnosis of ad for at least 2 years. * subjects who have iga score of 2 (mild) or 3 (moderate) for ad severity. * subjects who have ad involvement of 3-20% of the body surface area (bsa) and does not include the scalp. exclusion criteria: * female subjects who are pregnant, nursing or planning to become pregnant during study participation. * subjects with a history of hypersensitivity or allergy to ruxolitinib and/or any of the study medication ingredients * subjects with unstable course of ad (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline. * subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of ad (e.g., other types of eczema, pigmentation, or extensive scarring).
comparison of glidescope-specific rigid stylet to standard malleable stylet for glidescope intubation by novice operators

Conditions: Airway

Summary: patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tube (ett) stylets. the intubation will be done with a glidescope videolaryngoscope by a novice operator. the primary outcome is time to intubation.


Eligibility criteria:
inclusion criteria: * any adult patient scheduled for elective surgery. * ett is indicated for the procedure in the opinion of the attending anesthesiologist. * any operator who has performed ≤ 10 glidescope intubations. exclusion criteria: * any patient in whom the use of the glidescope is contraindicated in the opinion of the attending anesthesiologist. * patient with known cervical spine abnormalities. * any patients with known or probable difficult airways. (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data). * any patient requiring rapid sequence induction.
study of how low blood sugar affects the way blood vessels work

Conditions: Hypoglycemia

Summary: hypothesis: low blood sugar (hypoglycemia) decreases function of the lining of the blood vessels in normal humans. this study is designed to explore how hypoglycemia affects the function of the blood vessel lining. this will be determined by measuring blood flow to the arm before and after occlusion of flow. blood vessel function will be measured before induction of hypoglycemia, during insulin induced hypoglycemia, and after recovery from hypoglycemia. a second study will be done but without hypoglycemia.

purpose: the purpose of the research is to learn more about how low blood sugar (low blood glucose or hypoglycemia) affects the way the blood vessels work in healthy people. subjects who participate in this research project must be in good health and taking no medications. methods: a screening visit to the clinical research center of the ohio state university will be used to assess eligibility to participate. the main study consists of two visits to the clinical research center that occur two to four weeks apart. each of these visits will involve a procedure known as an insulin clamp. this involves giving insulin and sugar water into a vein. the amount of sugar given varies to keep the blood sugar at a predetermined level. for one of the two visits the blood sugar will be low and the other it will be normal. the function of the blood vessels will be measured three times during each study by measuring blood flow before and after stopping blood flow to the arm for 5 min.

Eligibility criteria:
inclusion criteria: * age 18-40 years * bmi \<27 kg/m2 exclusion criteria: * pregnancy * systolic blood pressure \>140 mmhg * diastolic blood pressure \>90 mg/dl * spot daytime urine microalbumin concentration \> 20 μg/mg creatinine * past or present history of chronic disease (e.g. cancer, hypertension, cardiovascular disease, chronic inflammatory disease) other than diabetes in type 1 diabetic subjects. * use of non prescription medications in the past 3 days * use of prescription medications in the past 2 weeks

Keywords: hypoglycemia endothelial function
open label safety and efficacy study of levetiracetam in patients with epilepsy

Conditions: Epilepsy, Partial

Summary: community based study assessing safety and efficacy of levetiracetam in partial onset seizures. the optimal dose in daily clinical practice will be used.


Eligibility criteria:
inclusion criteria: * subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized. * subjects must present between 3 and 42 partial seizures over the three months prior to protocol visit 1. * use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (aeds) at the time of trial entry. exclusion criteria: * subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months. * presence of known pseudoseizures within the last year. * presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors. * uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Keywords: epilepsy partial onset seizures keppra levetiracetam
direct full-stage implantation of sacral neuromodulation

Conditions: Urinary Bladder, Overactive; Urge Incontinence

Summary: the purpose of this investigator-initiated study is to investigate the efficacy and costs of direct full stage sacral neuromodulation in patients with overactive bladder. patients with refractory oab and urge urinary incontinence will undergo direct full stage implantation and be followed for a period of 6 months to monitor symptom improvement with voiding diaries and validated questionnaires preoperatively and postoperatively. therapeutic and adverse outcomes will be evaluated. the use of medical resources and time off of work will be analyzed as well. this will be a descriptive study with no additional arms or randomization.


Eligibility criteria:
inclusion criteria: * patients \>18 years of age * female gender * refractory overactive bladder: wet failing treatment with two or more anticholinergic and/or beta-3 agonist agents * willing to stop treatment with anticholingeric and/or beta-3 agonist agents during the study period (2 week washout period preoperatively and 6 months postoperative) * willing and able to complete study questionnaires, use medtronic device programmer, return for scheduled follow-up appointments * surgical candidate able to hold antiplatelet or anticoagulation prior to surgery * health insurance provider that will cover full-stage implantation exclusion criteria: * age \<18 * pregnant or planning to become pregnant * male gender * unable or unwilling to stop anticholingeric and/or beta-3 agonist agents during the study period * treatment with botulinum toxin within last 6 months * recent surgery for stress urinary incontinence or pelvic organ prolapse within last 6 months * severe pelvic organ prolapse * post-void residual \>150 ml * symptomatic or recurrent urinary tract infection * neurologic disorders: cerebrovascular accident with neurologic deficits, parkinson's, multiple sclerosis, spinal cord injury, significant peripheral neuropathy * cognitive disorders, e.g. dementia * interstitial cystitis or chronic pelvic pain syndrome * poorly controlled diabetes mellitus (hba1c \>10%) * history of bladder malignancy, pelvic radiation, urinary retention requiring catheterization * anticipated or known need for mri at the trunk * history of or anticipated surgery at the lower back * unable to hold antiplatelet or anticoagulation prior to surgery * life expectancy \<1 year
(neo)adjuvant ide196 (darovasertib) in patients with localized ocular melanoma

Conditions: Uveal Melanoma

Summary: neoadjuvant/adjuvant ide196 (darovasertib) in patients with primary uveal melanoma

phase 2 multi-center open-label ide196 study in patients with primary uveal melanoma requiring either enucleation or plaque brachytherapy. patients will be treated in neoadjuvant setting up to 6 months (or maximum benefit) followed by primary local therapy. an additional 6 months of adjuvant treatment to follow with long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.

Eligibility criteria:
inclusion criteria: * primary localized uveal melanoma requiring either enucleation or plaque brachytherapy * able to dose orally * ecog performance status of 0-1 * no other significant underlying ocular disease * adequate organ function * not pregnant/nursing or planning to become pregnant. willing to use birth control exclusion criteria: * previous treatment with a protein kinase c (pkc) inhibitor * concurrent malignant disease * active hiv infection or hep b/c * malabsorption disorder * unable to discontinue prohibited medication * impaired cardiac function or clinically significant cardiac disease * any other condition which may interfere with study interpretation or results

Keywords: uveal melanoma plaque brachytherapy enucleation neoadjuvant adjuvant protein kinase c ophthalmology ocular oncology darovasertib ide196 ocular melanoma choroid melanoma plaque brachytherapy
study to evaluate the efficacy and safety of sirolimus in subjects with metastatic, mismatch repair deficient solid tumors after immunotherapy

Conditions: Metastatic dMMR Solid Cancer; Solid Tumor; Cancer; Metastatic Solid Tumor

Summary: to evaluate the efficacy of sirolimus by estimating the overall response rate (orr) as assessed by response evaluation criteria in solid tumors version 1.1 (recist v1.1) in patients with metastatic dmmr solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment).

despite recent therapeutic strategies, including immunotherapy, treatment alternatives for patients with metastatic mismatch-repair deficient (dmmr) solid tumors remain scarce. pre-clinical data suggests that dmmr tumors are susceptible to rapamycin (sirolimus), an mtor inhibitor. in these tumors, characterized by higher levels of oxidative stress, sirolimus can exert a cytotoxic effect, led by the failure to repair dna damage by inhibition of antioxidant enzymes such as foxo3a triggered by akt hyperactivation. this proposal presents a phase 2 clinical trial designed to evaluate the efficacy of sirolimus in patients with dmmr solid tumors after immunotherapy. the investigators hypothesize that sirolimus will increase the overall response rate (orr) by 20%.

Eligibility criteria:
inclusion criteria: * metastatic solid cancer tumor after immunotherapy (either due to progression of disease or inability to tolerate treatment) * dmmr by immunohistochemistry (ihc) defined as the loss of expression in any of the four major mmr proteins (mlh1, msh2, msh6 and pms2) or by next- generation sequencing (ngs) * age older than 18 at the time of informed consent * eastern cooperative oncology group performance status of 0-2 * ≥1 measurable lesion based on recist, version 1.1 (16) * absolute neutrophil count (anc) ≥1,500 mm3 * platelet count ≥75,000 mm3 * hemoglobin ≥ 9 g/dl * aspartate aminotransferase (ast) ≤3.0 times the upper normal limit (unl) * alanine aminotransferase (alt) ≤3.0 times the upper normal limit (unl) bilirubin ≤1.5 times the unl * serum creatinine ≤1.5 times the unl exclusion criteria: * received immunotherapy in the prior 21 days. * have not recovered from toxicities of prior treatments to at least grade 1. * symptomatic central nervous system (cns) metastases * pregnancy or breast-feeding.
patient-reported outcomes and lung function after hospitalization for covid-19

Conditions: Covid19; Lung Function Decreased

Summary: a multicenter prospective cohort study performed at 6 major teaching hospitals in southern norway to study patient reported outcomes, lung function and pulmonary ct in patients at 3 and 12 months after hospitalization for coronavirus disease 2019 (covid-19).

this cohort study aim to describe the natural course of covid-19 disease in an consecutive and unselected cohort of norwegians that have been hospitalized. in addition to the primary and secondary outcomes related to proms, lung function and pulmonary ct, the study also have several substudies: cardiology: the study includes echocardiography, 24-h electrocardiography and cardiopulmonary exercise test. ent: the study includes ct of head sinuses and patient-reported sleep disturbances and nose symptoms in a subgroup of patients. laboratory: analyses of common markers of inflammation and cardiac biomarkers.

Eligibility criteria:
inclusion criteria: * discharged before june 1 2020 after hospitalization at participating hospital for covid-19 exclusion criteria: * age \< 18 years * dementia * living outside hospital catchment area * participation in who covid-19 clinical trial
efficacy and safety of cdp870 and methotrexate compared to methotrexate alone in subjects with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the main purpose of the study was to determine the efficacy of cdp870 in treating ra signs/symptoms in patients who were partial responders to mtx. other purposes were to show additional efficacy without increased toxicity and the immunogenic response to cdp870 during combined cdp870 and mtx therapy.


Eligibility criteria:
inclusion criteria: * male/female, 18-75 years old, inclusive * diagnosis of adult-onset ra * had active disease * had received methotrexate * on a stable dose of folic acid exclusion criteria: * contraindication for methotrexate or anti-tnf

Keywords: cdp870 certolizumab pegol
effect of inhaled pre-prandial human insulin on blood glucose control in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). this trial will compare the changes in hba1c after 26 weeks of inhaled insulin or rosiglitazone treatment, both in combination with metformin and glimepiride.

the decision to discontinue the development of aerx® is not due to any safety concerns. an analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * currently treated with antidiabetes drugs (including exenatide) for at least 2 months * hba1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy * bmi less than or equal to 40 kg/m2 exclusion criteria: * current smoking or smoking within the last 6 months * current acute or chronic pulmonary disease (except for asthma) * proliferative retinopathy requiring acute treatment * clinically significant disease history including kidney or liver disease * heart disease which limits physical activity or results in discomfort with physical activity * pregnancy
usage of procalcitonin to reduce antibiotics duration in vap in neurosurgical icu

Conditions: Antibiotic Side Effect

Summary: using procalcitonin tests to reduce antibiotics duration in neurosurgical patients with ventilated associated pneumonia

patients who are more than 18 years old who are admitted to neurosurgical icu will be recruited 48hours after ventilation if matches criteria for ventilator associated pneumonia. patients will be randomised into 2 groups. first group will be procalcitonin guided in addition to conventionally guided sepsis assessment (twc, crp, body temperature). second group is only conventionally guided sepsis assessment. in procalcitonin guided group, blood sample will be taken on day 1 of recruitment and day 5. on day 5 , the procalcitonin level will be compared to recommendations in prorata trial. if procalcitonin level is below the level to withhold antibiotics, recommendation will be made to the primary physician to off the antibiotics. another procalcitonin level will be repeated on day 7 to rule out reinfection. this study aims to compare the duration of antibiotics and length of icu stay among the 2 groups. this study will fill up the gap among the lack of datas in neurosurgical patients.

Eligibility criteria:
inclusion criteria: * patients admitted to neuro-icu \& trauma icu * patients aged \>18 years old. * ventilation for \>48 hours * vap and treated with antibiotics \<24hours prior to inclusion in trial. * patient with arterial line or central line exclusion criteria: * patients who are on antibiotics but not assumed or proven to have vap * expected short icu stay (\<3 days) * non-bacterial infections * long term antibiotic treatment (transplant or chemotherapy patients, endocarditis, osteomyelitis) * hospitalisation 48hours before enrolment * severe immunosuppression * pregnancy * primary team's decision to continue antibiotics for 14 days prior to trial * dnar or expected to die within 5 days
benepali® pen patient satisfaction survey

Conditions: Rheumatoid Arthritis; Spondyloarthropathies

Summary: the main aim of this study is to ascertain general satisfaction among participants with rheumatic diseases with day-to-day use of the benepali® prefilled pen by means of a standardised participant questionnaire. in addition, it is to be investigated whether differences exist in general participant satisfaction between participant groups who have undergone various prior treatment and/or have previous experience with application systems (participants new to the use of biologics, participants changing over from a prefilled injection or changing over from another pre-filled pen) and between participants of the various indication groups. furthermore, the participants are to evaluate various aspects of using the benepali® pre-filled pen based on their personal experience, such as e.g. handling, user-friendliness and features of the benepali® pre-filled pen, as well as the effectiveness of the training on injection with the benepali® pre-filled pen, based on participant satisfaction with the training received with the training pen and the evaluation of the training material received.


Eligibility criteria:
key inclusion criteria: * diagnosis of moderate to severe active rheumatoid arthritis, severe active and progressive rheumatoid arthritis, active and progressive psoriatic arthritis, severe active ankylosing spondylitis, or severe non-radiographic axial spondyloarthritis * current treatment with the benepali® pre-filled pen in accordance with prescribing information for at least 3 months beforehand * the patient has signed a declaration of consent to take part in the study key exclusion criteria: * patients who are receiving benepali® for the treatment of moderate to severe plaque psoriasis * patients who exhibit contraindications in accordance with the prescribing information for benepali® and therefore treatment with benepali ® is not indicated note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: ankylosing spondylitis axial spondyloarthritis benepali pen etanercept patient questionnaire pre-filled pen biological dmards antirheumatic drug
interest of dynamic measures of the pupil in optic neuritis

Conditions: Optic Neuritis

Summary: the investigators' hypothesis is that measuring the pctdynamics would be an easy and reliable symptom to evaluate in pathologies affecting the optic nerve

physiopathologic study aiming to assess the interest of measuring the lenght of pupil cycle in the dynamic study of the pupillary light reflex.

Eligibility criteria:
inclusion criteria: * patients with unilateral optic neuritis or with multiple sclerosis and an optic neuritis in the previous 5 years exclusion criteria: * previous history of ophthalmic and neurologic pathology * anisocoria * minor * patient with a measure of legal protection * pregnancy * patient opposition to participation in the study * no affiliation to social security

Keywords: multiple sclerosis diameter pupil