Kornimate/medical-research-clean huggingface dataset:
safety trial of high dose oral vitamin d3 with calcium in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: vitamin d likely plays a role in the geography of multiple sclerosis (ms), and patients at risk and with ms have relatively low vitamin d levels compared to their normal counterparts. this trial examines the safety of high dose oral vitamin d3 titrated up to a maximum of 40,000 iu per day over a 12 month period. fifty patients matched for ms and non-ms characteristics will be divided into two groups: one group receiving the high dose vitamin d regimen, and the other restricted to a maximum of 4000 iu per day. the hypothesis is that patients with ms can tolerate seemingly high doses of vitamin d3 without adverse events and/or calcium-related abnormalities. it is also hypothesized that those receiving the higher doses will demonstrate improved relapse and disability status compared to controls, and that the treatment group will show improved markers of bone health and immune indicators of reduced inflammation.


Eligibility criteria:
inclusion criteria: * clinically definite ms * age 18-55 * edss 0-6.5 exclusion criteria: * edss =\> 7.0 * current vitamin d3 use \>4000 iu/d * baseline (25(oh)d) level \ 150 mmol/l * pregnancy or inability/unwillingness to use contraception * history of cardiac arrhythmia * history of renal disease and nephrolithiasis * history of granulomatous disease or lymphoma * relapse activity or steroid use in the past 60 days

Keywords: multiple sclerosis vitamin d safety
trial to evaluate time to symptom relief and elimination of infecting bacteria in treating sinusitis with avelox

Conditions: Maxillary Sinusitis

Summary: this study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. the study also examined the time to resolution of key symptoms associated with sinusitis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute sinusitis with signs and symptoms present for \>7 days but \ 38.0°c/100.4°f, tympanic \> 38.5°c/101.2°f)\*\*\* purulent secretions obtained via middle meatus secretion sampling using nasal endoscopic technique; the specimen sent for gram stain, culture and susceptibility testing prior to initiation of antimicrobial therapy exclusion criteria: * history of chronic sinusitis defined as greater than four weeks of continuous symptoms (patients with history of sinus surgery may be included; patients with recurrent sinusitis may be included) * known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses- received systemic antibacterial therapy likely to be effective in sinusitis for more than 24 hours within 7 days of enrollment- a requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol- known immunodeficiency diseases including aids (cd4 \ 4 weeks prior to enrollment- history of allergy to quinolone antibiotics or related compounds- pregnant or breast feeding- of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception * received an investigational drug in the past 30 days- unable to take oral medication- known to have congenital or sporadic syndromes of qtc prolongation or receiving concomitant medication reported to increase the qtc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine) * end stage liver cirrhosis (class child-pugh c)- severe renal impairment requiring dialysis * previous history of tendinopathy associated with quinolones- any symptoms that suggest that the patient's current illness is allergic rhinitis (e.g., repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis * diagnosis of rapidly fatal illness with a life expectance of less than 6 months- previously enrolled in this clinical study- uncorrected hypokalaemia

Keywords: sinusitis
evaluation of brain waste clearance pathways using magnetic resonance imaging in pediatric patients with white matter diseases

Conditions: Glymphatic System; White Matter Disease; Pediatric Disorder; Perivascular Disease

Summary: the dilation of perivascular spaces can be the result of various etiopathogenetic processes. white matter atrophy can cause enlargement of these perivascular spaces (pvs) but also obstruction of fluid drainage systems (interstitial fluid, isf) and metabolites, as evidenced by some recent studies. focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction. dilation of pvs can be associated with changes in white matter and microhemorrhages. we want to study these etiopathogenetic phenomena by implementing specific mri methods.

primary objective: the quantification of indirect magnetic resonance markers of altered waste drainage systems using validated scales in patients with white matter disease. secondary objective: the evaluation of white matter alterations in relation to the known anatomical glymphatic pathways by analyzing both structural and diffusion data.

Eligibility criteria:
inclusion criteria: * patients with and without white matter disease * patients willing to participate in research with signed consent form * no age limit (results will be age matched) exclusion criteria: * unwilling to participate in research

Keywords: glymphatic system white matter disease perivascular space diffusion tensor imaging gadolinium rare disease
mitral valve prolapse, arrhythmias and mitral valve surgery

Conditions: Mitral Valve Prolapse; Cardiac Arrhythmia

Summary: mitral valve prolapse (mvp) is associated with malignant ventricular arrhythmias (va) and sudden cardiac death. a proper electrophysiological and echocardiographic characterization of this population is missing. moreover, the effects of mitral valve repair on the arrhythmic burden are still matter of debate. the investigators sought to explore the role of the arrhythmic substrate in the risk stratification of patients with mvp and to assess whether mitral surgery is followed by a significant modification of the baseline arrhythmic pattern.

this is a prospective observational study, enrolling 200 patients with mvp and any documented va. diagnosis of va obtained by 12 leads ecg and holter recordings will be reported, as well as preprocedural premature ventricular contractions (pvc) burden assessed by 24-hour holter monitoring; demographic and clinical data will be collected, including symptoms, documentation of va and atrial fibrillation (af). echocardiography data will be analyzed, focusing on mitral regurgitation grading and mitral valve morphology analysis, assessment of leaflet redundancy and prolapse, chordal elongation, annular dilatation, presence of calcifications and mitral annular disjunction characterization. patients will undergo ecg holter monitoring before cardiac surgery with the aim to identify any va and estimate pvc burden. ecg holter monitoring will be repeated at 3, 9, and 12 months after cardiac surgery. in case of intraoperative biopsy, the result of histopathological examination will be collected. for patients undergoing cardiac imaging, including cardiac magnetic resonance or computer tomography, data regarding cardiac volumes, function, markers of fibrosis will be collected. in patients undergoing programmed electrical stimulation (pes) and electroanatomical mapping (eam), size of bipolar and unipolar endocardial abnormal voltage areas, late potentials (lp) area, results of programmed electrical stimulation, will be evaluated.

Eligibility criteria:
inclusion criteria: 1. adult 18 years of age or older, at the time of inclusion; 2. hospitalized or presented in outpatient visit; 3. and presented with: • diagnosis of mvp 4. who underwent electrophysiological evaluation or cardiac surgery for mitral valve disease. exclusion criteria: 1. patients not willing to participate to the study 2. patients without clinical evaluation of the arrhythmic profile.

Keywords: sudden cardiac death premature ventricular contraction mitral valve surgery
sepsis prognosis and diagnosis in the emergency department (speed)

Conditions: Respiratory Tract Infections; Urinary Tract Infections; Intra-Abdominal Infections; Skin and Soft Tissue Infection; Suspected Meningitis/Encephalitis or Any Other Infection; Sepsis

Summary: this study aims to evaluate the diagnostic and prognostic performance of a novel mrna diagnostic/prognostic classifier (interprets the expression of 29 host response mrna biomarkers) from whole blood in adult patients presenting to emergency departments (ed) with suspected infection.

study measurements consists of a blood collection via venepuncture into a paxgene® blood rna tube (2.5 ml) and na-heparin tube (4 ml) normally within 1 hour of enrolment into the study. the samples will be stored and transferred in batches from recruiting centres to a core laboratory. the expression of 29 mrnas contained in the imx-bvn-4/sev-4 classifier will be analysed to determine the likelihood of bacterial and viral infection, as well as the likelihood of clinical deterioration. a nasopharyngeal swab sample will also be obtained for participants with suspected respiratory tract infection. clinical data collection will be recorded from source data using an electronic case report form (ecrf) the diagnosis of infection will be confirmed by a clinical adjudication panel blinded to the ed and hospital discharge diagnosis for each case.

Eligibility criteria:
inclusion criteria: adult participants (16 years and older) presenting to the ed (or related assessment and treatment facilities such as sdec or amu) with: 1. clinically suspected infection of any aetiology as the reason for attendance; and 2. news2 score of ≥2 (any dimension, using latest score) exclusion criteria: 1. treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the ed visit. participants will not be excluded for use of: * antiviral treatment for hiv infection and hepatitis b and hepatitis c * topical antibiotics, topical antiviral or topical antifungal agents * anti-herpes prophylaxis aiding suppression of a recuring herpes infection * peri-operative (prophylactic) antibiotics * a single dose of antimicrobials during the present ed visit; note single dose can be considered mono- or combination therapy, wherein combination is administered as part of local standard of care and only one dose of each medication is administered 2. presence of an advance directive to withhold life-sustaining treatment or a clear plan in place to that effect (ie. an explicit decision by patient/family/carer in conjunction with clinical team that active treatment beyond symptomatic relief is not appropriate). note that patients who do not wish to receive cardiopulmonary resuscitation (cpr) but active treatment is still indicated may still qualify for entry into study 3. prisoners or those in police custody 4. patients who permanently lack the capacity to give informed consent 5. previously enrolled in speed uk study

Keywords: infection mrna host response
a prospective phase ii study of individualized neoadjuvant chemoradiotherapy for rectal cancer based on recurrence risk

Conditions: Rectal Cancer

Summary: a prospective phase ii study of individualized neoadjuvant chemoradiotherapy for rectal cancer based on recurrence risk

for patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. rectal magnetic resonance imaging (mri) can be used to stratify the risk of locally advanced rectal cancer before treatment. in this study, we planned to use rectal mri parameters and the possibility of patients with anal preservation to group, and to observe the r0 resection rate and disease-free survival rate of patients with stage ii / iii rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.

Eligibility criteria:
inclusion criteria: 1. rectal adenocarcinoma confirmed by histopathology 2. mri staging was stage ii / iii (ct3-t4n0 or ct2-4n+) 3. the age is 18-75 years old, no gender limit 3) the distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) karnofsky score ≥ 80 or ecog score 0-1 exclusion criteria: 1. history of other malignant tumors; 2. they were allergic to 5-fu, platinum, etc; 3. the patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred; 4. after the previous renal history, proteinuria or clinical renal function were found to be abnormal; 5. history of gastrointestinal fistula, perforation or severe ulcer; 6. at present, there are active infection; clinical obvious heart disease; new york heart association (nyha) ≥ grade ii congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade ii; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.

Keywords: rectal cancer neoadjuvant chemoradiotherapy recurrence risk
post covid-19 biorepository

Conditions: Coronavirus Infection

Summary: establish a biorepository, clinical data registry, and radiographic image database from individuals who were covid positive at one time and are being seen for outpatient follow-up or a separate study visit.

living patients or their healthcare surrogates will provide informed consent prior to participation in the biorepository. surrogate decision makers who cannot consent in person will be consented in accordance to the kumc remote consent guidelines. biospecimens to be collected include serum, plasma and whole blood. blood samples will be collected during face-to-face encounters in the post-covid-19 clinic within the tukhs pulmonary clinic or will be coordinated with other outpatient follow-up appointments (including separate procedure/lab-related visits) or separate study visits for ongoing, indepent studies. samples will be collected at time of consent as well as at potential follow-up visits at approximately 3, 6, 12, and 12 months from enrollment. blood samples will be processed, aliquoted, and stored at -80°c. a portion of the blood samples will be kept for dna and rna isolation, and a portion of plasma collected might be utilized to isolate peripheral blood mononuclear cells. biospecimens will be labeled with the patient's study id number, date of sample processing, and specimen type. biospecimens will be stored through the duration of the study. if the patient chooses to withdraw consent, his or her samples in the biorepository will be destroyed. biospecimens that have been previously used or disseminated will continue to be utilized. future research may include whole genome testing, and these results will not be shared with the patient or their standard of care physician. patient data and historical radiographic imaging from after the date of consent will be collected using tukhs medical records and stored in redcap. the data to be collected is outlined in the data collection sheets.

Eligibility criteria:
inclusion criteria: 1. the participant is a patient at tukhs or has agreed to participate in a study approved by the kumc human research protection program (hrpp). 2. the participant has a previous diagnosis of covid-19 confirmed by covid-19 pcr or antibody testing and is being seen for outpatient follow-up. 3. patient is ≥ 18 years of age or older. exclusion criteria: 1. participant declines to participate. 2. participant or healthcare surrogate is unable to provide informed consent.
progrp, cga, nse and tum2-pk in in patients with neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: the purpose of this study is to determine whether monitoring of levels of serological markers progrp, cga, nse and pyruvate kinase m2 are effective in the evaluation of diagnosis, monitoring therapeutic effects and predicting response to somatostatin analogues in patients with malignant neuroendocrine tumors.

assessment of the anatomical spread and disease progression in neuroendocrine tumor patients has become an essential part of disease management, but sometimes in many patients difficult to be measured. therefore, the evaluation of serum markers could represent a useful tool for monitoring the course of the disease and the response of patients to therapy or palliative treatment.clinical data considers cga and nse as available today blood biomarkers for neuroendocrine tumors.until now the usefulness of serum progrp as a clinical tumor marker has been evaluated mainly in small cell lung carcinoma, while its role in the management of ne tumors has not been elucidated.available in the literature limited data suggests that progrp may be a potential tumor marker in ne tumors. pyruvate kinase type m2 is the key glycolytic regulator in tumor cells.it catalyzes the dephosphorylation of phosphoenolpyruvate to pyruvate with atp production.the dimeric form of this enzyme (tum2-pk) has been detected in the blood of patients with different cancers.high tum2-pk expression was suggested to be an important element of tumor cell metabolism adaptation to an inadequate oxygen and nutrient supply.recently, it has been shown that somatostatin and its structural analogues pass through cell membrane and actively bind to cytosolic tum2-pk. in response to this binding tum2-pk translocates into the nucleus and induce programmed cell death. it is suggested that tum2-pk enzyme may contribute significantly to response of neuroendocrine tumors to somatostatin analogues.

Eligibility criteria:
inclusion criteria: * the patients at diagnosis of neuroendocrine tumors before therapy will be approached to participate in the study. * older then 18 years old * patients who agree to participate will receive a detailed explanation and sign an informed consent form. exclusion criteria: * pregnant women * coexistence of another primary malignant tumor other then neuroendocrine tumors

Keywords: progrp cga nse tum2-pk neuroendocrine tumors
smartphone twelve lead electrocardiogram utility in st elevation myocardial infarction

Conditions: ST Elevated Myocardial Infarction

Summary: the primary objective is to determine if the smartphone electrocardiogram (ecg) is an acceptable replacement for a standard ecg in the identification of st elevation myocardial infarction (stemi).

toward this objective, this study involves the following: * obtain simultaneous recordings of a standard 12-lead ecg and the iphone "12-lead equivalent" ecg on patients presenting with chest pain in which the stemi protocol was activated. * obtain simultaneous recordings of a standard 12-lead ecg and the iphone "12-lead equivalent" ecg on patients presenting to the emergency department for evaluation of chest pain, not necessarily presenting with stemi. * reading of ecgs (standard 12-lead and iphone) by three independent cardiologists, who are blinded to the initial clinical ecg readings, the type of ecg equipment used, and the patient's clinical information. * assess the operational feasibility of using the smartphone to obtain "12-lead equivalent" ecg recordings in patients suspected to have stemi, and * determine the possibility of pooling the data obtained from this study with data from other institutions conducting identical studies, and developing a future irb-approved protocol and statistical analysis plan to compare the sensitivity, specificity, positive predictive value and the negative predictive power of the iphone ecg, using a paired standard 12-lead ecg as the gold standard. there will be no therapeutic interventions. a single research-related procedure will be required, i.e. an iphone ecg. effort will be made to ensure that the performance of this procedure will not delay any treatment and/or diagnostic procedures that are part of usual or specialized care that the patient requires. effort will be made to enroll 1 stemi patient for every 2 non-stemi patients.

Eligibility criteria:
inclusion criteria: * male or female \>= 18 years of age. * ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures (patient or legally acceptable representative). * symptoms of chest pain upon presentation at the integris baptist medical center emergency department exclusion criteria: * inability or refusal of the patient and/or the patient's legally-acceptable representative to provide written informed consent for any reason. * other conditions that in the opinion of the principal investigator or co-investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial.
prospective longitudinal monocentric study to evaluate the syde® digital endpoint in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the study aims to assess the validity of real-world activity monitoring by the syde® wearable device in subjects with multiple slclerosis. the syde® collected data will be compared to on-site conventional clinical endpoints for ms pathology (edss, fss and t25fwt). subjects with multiple sclerosis will be assessed every 6 months for 2 years.


Eligibility criteria:
inclusion criteria: 1. male or female subject aged from 18 to 65 years old. 2. signed informed consent and ability to comply with study and follow-up. 3. diagnosed with ms base on 2017 mcdonald criterion 4. edss ≤ 5.5 5. no clinical or radiological relapse within the last 3 months 6. for patient under treatment, the molecule and its dose should be stable about 2 months before inclusion 7. subject willing and able to comply to all study procedures including the syde® related ones exclusion criteria: 1. patient with a cognitive or communicational disorder disturbing the understanding of the tasks or data collection 2. previous or current disorder with an impact on current ambulation or motor function 3. patient who have had surgery or traumatic injury in upper or lower limb within the last 6 months before the inclusion or patients who have had major surgery or trauma within the last 6 months before the inclusion

Keywords: digital health technology