Kornimate/medical-research-clean huggingface dataset:
predictive questionnaire for vitamin d insufficiency in healthy adults

Conditions: Healthy Volunteers

Summary: the purpose of this clinical study is to evaluate the metrological properties of a questionnaire that aims to identify the vitamin d status in reference to a vitamin d blood dosage.

each subject will perform only one visit (visit v1). the study duration per subject will last about 2 hours. during this visit v1, the subjects will perform a medical exam in order to check their eligibility (general statement and check of inclusion / non-inclusion criteria). the eligible subjects will fill up a study questionnaire and will perform a blood sampling for a dosage of serum vitamin d.

Eligibility criteria:
inclusion criteria: * male and female volunteers * subject able to communicate with the investigator and the study team, able to read and write and follow all study instructions. * written informed consent provided and signed prior screening, after receiving and understanding the subject information. * registered with the french social security, in agreement with the french law on biomedical experimentation. exclusion criteria: * subject with diagnosed osteoporosis, osteopenia or osteomalacia. * subject with known disease that contributes in osteoporosis: rheumatoid arthritis, malabsorption syndrome, inflammatory bowel disease, hyperthyroidism, hyperparathyroidism. * subject with known hepatic impairment. * subject with known liver impairment or with a history of renal transplantation. * subject with history of cancer. * subject with history of bariatric surgery. * subject taking or having taken osteoporosis inducing treatment, or treatment with an effect on calcium and phosphorus metabolism during the 3 months prior the visit: corticosteroids, enzyme inducing anticonvulsants, heparin. * subject requiring vitamin d supplementation for a diagnosed pathology. * pregnant or breastfeeding female. * subject with history of alcohol or drug abuse. * participation to any other clinical trial simultaneously and/or not having ended the exclusion period of another clinical trial. * subject of legal age unable of giving consent. * subject deprived of liberty by judicial or administrative decision. * subject of legal age under legal protection. * subject having received over 4500 euros for clinical trial participation within the prior year including the indemnity for the present study.

Keywords: vitamin d vitamin d deficiency vitamin d insufficiency healthy adults predictive questionnaire
ai enrich - ai detection of ich

Conditions: Intracerebral Hemorrhage

Summary: to evaluate the performance of the viz recruit software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation.

this study will be a multicenter prospective feasibility trial to evaluate the performance of the viz recruit software. this study will enroll subjects evaluated at each center for stroke via ct imaging. the viz recruit software will review the ct and notify a specialist if an ich is detected. it will also evaluate the ich parameters per study specific guidelines related to the enrich trial and notify a specialist if their ich meets the study inclusion or exclusion criteria related to cerebral blood flow volume. if an enrolled subject is ultimately included in the enrich trial, they will be identified in a prospective cohort of subjects exposed to viz (intervention arm) will be evaluated per the secondary endpoints to a cohort of subjects retrospectively from the enrich trial (control arm) which were evaluated and enrolled prior to viz use.

Eligibility criteria:
inclusion criteria: * subjects with stroke symptoms who undergo ct brain imaging. exclusion criteria: * subjects with poor or incomplete ct brain imaging.

Keywords: artificial intelligence ich
dna methylation for screening uterine cervical lesions

Conditions: DNA Methylation; Uterine Cervical Cancer; High Grade Squamous Intraepithelial Lesions; Low Grade Squamous Intraepithelial Lesions

Summary: the primary objective of this study is to compare the testing of dna methylation, high-risk hpv subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study. this study will include 300 unselected patients with definite histological results. all the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of dna methylation, high-risk hpv subtypes and thin prep liquid-based cytology test (tct). the sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. the differences of dna methylation with high-risk human papillomavirus (hpv) and tct will also be analyzed. the testing of dna methylation will be performed with the methylation-specific polymerase chain reaction (pcr). the tct and hpv testing will be performed with the roche kits.


Eligibility criteria:
inclusion criteria: * confirmed cervical histology within one month when collecting cervical cytology * aged 18 years or older * signed an approved informed consents exclusion criteria: * not meeting all of the inclusion criteria
compression gloves for distal radius fracture

Conditions: Distal Radius Fractures; Fracture of Lower End of Radius; Colles' Fracture; Smith's Fracture

Summary: distal radius fractures are among the most common orthopedic injuries. rehabilitation may be characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers), and grip strength. compression gloves are used to enhance rehabilitation after various clinical conditions and injuries. however, there are no reports on the effect of compression gloves following distal radius fracture (drf). this study aims to assess the incremental effect of wearing made-to-measure compression gloves on rehabilitation following drf. working hypothesis: the addition of made-to-measure compression gloves to routine follow up and treatment will enhance rehabilitation, when compared with routine follow up and treatment, in patients following distal radius fracture. icd 10, version 2010, conditions to be included in the study (defined jointly as distal radius fractures): s52.5 fracture of lower end of radius (colles' fracture, smith's fracture) s52.6 fracture of lower end of both ulna and radius s52.7 multiple fractures of forearm excl.: fractures of both ulna and radius: lower end (s52.6), shafts (s52.4). s52.8 fracture of other parts of forearm (lower end of ulna, head of ulna)

individuals referred for rehabilitation following drf will be invited to participate in the study. after obtaining an informed consent individuals will be randomized to receive routine follow up and treatment with or without compression glove. individuals randomized to made to measure compression gloves will receive them within a week of enrolment. all participating individuals will be assessed by an occupational therapist at enrolment and 2, 4, and 8 week after enrolment. additional telephone interview, to assess long term effect, will be conducted at 3, 6 and 12 months.

Eligibility criteria:
inclusion criteria: 1. 4-6 weeks following either surgical or conservative treatment for distal radius fractures, with or without the involvement of the ulna. 2. patients who demonstrate at enrolment at least two of the following: * pain, * limited range of motion of the fingers and the wrist, * limited strength (weakness of the hand/fingers), * swelling /edema, * limited hand functions during performance of activities of daily living (adl). exclusion criteria: * neuropathy * peripheral vascular disease * end stage renal disease * previous impairment of fingers/wrist range of motion. * previous lymphedema of the injured hand * receiving any additional treatments which is not included in the routine follow up and treatment (i.e. acupuncture, steroids). * pregnancy

Keywords: colles' fracture compression bandages occupational therapy rehabilitation smith's fracture
a study to examine the safety, pharmacokinetics and pharmacodynamics of amg 403 in healthy subject

Conditions: Chronic Pain

Summary: this study is to evaluate the safety of amg 403 in healthy adult subjects. the study consists of a 21 day screening period followed by administration of the investigational product and up to 154 day evaluation period.


Eligibility criteria:
inclusion criteria: * healthy men and women of non-child bearing potential, * between the ages of 18 and 55 inclusive, * body mass index from 18 to 33 kg/m2, * skin type compatible with the study assessments, and without significant skin allergies, pigmentary disorders, tattoos, or any active dermatologic conditions that might interfere with the study conduct. exclusion criteria: * prior or current history of peripheral neuropathy, paraesthesias, dysesthesias, herpes zoster, post-herpetic neuralgia, * evidence of any current illness such as a common cold, viral syndrome, or flu-like symptoms, any disturbance of the autonomic nervous system, * history of raynaud's phenomenon; know allergy or intolerance to capsaicin or hot peppers.
inebilizumab in acute neuromyelitis optica spectrum disorders

Conditions: Neuromyelitis Optica Spectrum Disorder

Summary: this study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.

this is a a multicentric, prospective, real word study of inebilizumab in nmosd acute attack compared with oral immunosuppressant. a total of 50 patients will be enrolled at approximately 10 centers around china.

Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years with anti-aqp4-igg seropositive nmosd as defined by 2015 nmosd diagnostic criteria by ipnd (international panel for nmo diagnosis); 2. in the acute phase of nmosd (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever); 3. patients who plan to receive or are receiving intravenous methylprednisolone therapy; 4. expanded disability status scale (edss) score ≤ 8 and ≥ 2.5 during the screening period; 5. able and willing to give written informed consent; 6. women of childbearing potential who agree to use adequate contraception during the study. exclusion criteria: * 1. lactating and pregnant females; 2. participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment; 3. combined with severe mental disorders and other conditions and unable to cooperate with follow-up; 4. history of malignancies; 5. received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening; 6. patients with negative hepatitis b surface antibody (hbsag) and positive hepatitis b core antibody (hbcab), or hbsag-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history; 7. other situations that researchers think are not suitable to participate in this study.

Keywords: neuromyelitis optica spectrum disorder inebilizumab observational study
diazepam and blood pressure regulation

Conditions: Healthy

Summary: the aim of this study is to determine the acute effects of diazepam on beat-to-beat blood pressure variability and baroreflex control.

benzodiazepines are widely prescribed for a variety of clinical conditions. however, its cardiovascular consequences remain controversial. in this study, the investigators sought to determine the acute effects of a single dose of oral diazepam (10mg) on resting beat-to-beat blood pressure variability and cardiac and sympathetic baroreflex sensitivity in a cohort of young, healthy individuals.

Eligibility criteria:
inclusion criteria: * 18 to 40 years of age * healthy, free of known cardiovascular, metabolic, or musculoskeletal disease exclusion criteria: * history of smoking (tobacco or cannabis), defined as any smoking within the past 3 months * diagnosed cardiovascular or metabolic disease(s) * prescription of chronic medications other than oral contraceptives * history of hypertension or presence of arrhythmia

Keywords: blood pressure benzodiazepine autonomic nervous system
a study to collect information on the characteristics of elderly belgian patients with nvaf that are treated with a noac for this indication with a special focus on their fear of bleeding while using a noac vs the clinical benefit of a noac of thrombosis/stroke prevention.

Conditions: Non-Valvular Atrial Fibrillation

Summary: atrial fibrillation is a heart condition that causes an abnormal and fast heart rate. for people with non-valvular atrial fibrillation (nvaf), this is caused by problems such as high blood pressure and diabetes. nvaf happens more often in elderly people and can lead to stroke, heart failure, and death. doctors are currently able to give patients a type of treatment called an anticoagulant. anticoagulants work by making the blood thinner. they are thought to help reduce the risk of stroke and death caused by nvaf. in this study, researchers wanted to learn more about what elderly people think of taking anticoagulants that do not have any vitamin k in them. these are called non-vka oral anticoagulants (noacs). this study will include up to about 150 belgian men and women aged 75 years and over who have nvaf and have been treated with noacs. the study will also include about 10 doctors who have treated these patients. in this study, there will be no required tests or visits. instead, patients will answer a paper questionnaire about their use of noacs. the researchers will ask the doctors questions about how they treat their patients using noacs. the main types of questions the researchers will focus on are: * the patient characteristics of the elderly with nvaf who are treated with noacs * the level of fear of the elderly about bleeding while using a blood thinner and the fear of stroke/thrombosis. * the geriatrician's thoughts about using noacs to treat nvaf in elderly patients * those patient characteristics geriatrician's find most important when deciding on the anticoagulation treatment in the elderly patients. the information from this study will be collected between february and april 2021. but, the whole study will take about 6 months to finish and is expected to end in july 2021.


Eligibility criteria:
inclusion criteria: * male or female elderly patients (defined as ≥ 75 years old) diagnosed with nvaf * elderly patients treated with a noac * ambulatory patients visiting the geriatrician exclusion criteria: * contra-indications according to the local marketing authorization * patients suffering from dementia who are, according to the geriatrician's opinion, not able to understand and answer the questions * hospitalized patients
cardiac magnetic resonance assessment for heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: this is a prospective study that aims to define the utility of cardiac magnetic resonance feature tracking (cmr-ft) as a non-invasive quantification tool to assess diastolic functionality in patients with heart failure with preserved ejection fraction.

despite the increasing prevalence and poor prognosis of hfpef worldwide, it is facing diagnostic challenges due to its non-specific clinical manifestations. currently, echocardiography serves as the main diagnostic tool, but alternatives are limited to less preferred invasive procedures in most clinical situations. it is therefore proposed to investigate hfpef using cardiovascular magnetic resonance imaging (cmr), as an alternative non-invasive diagnostic tool which carries lower risk than invasive procedures. the study aims to: (1) access the utility of cmr-ft as a new indicator to diagnose diastolic dysfunction by differentiating hfpef patients from non-hfpef patient and normal volunteers. (2) compare accuracy of cmr-ft to cmr tagging and phase contrast imaging.

Eligibility criteria:
inclusion criteria: * patients presenting with symptoms and signs suggestive of hfpef * patients undergoing coronary catheterisation for stable chest pain with no evidence of diastolic dysfunction, heart failure, infarct, left ventricular ejection fraction \ 50% narrowing of one or more coronary arteries) * volunteers must be asymptomatic with no cardiac risk factors and no previous cardiac history exclusion criteria: * patients suspected to have hfpef but echocardiography and/or invasive pressure measurements do not confirm diagnosis of hfpef. * significant underlying ischaemia based on clinical history and non-invasive imaging or catheter coronary angiography if indicated. * contraindication to cmr study * estimated glomerular filtration rate \<30 ml/min/1.73 m2 * more than moderate valvular disease * severe pulmonary disease (ie. fev1 \<- 50% predicted) * cardiomyopathy * constrictive pericarditis
is there a digital divide in chronic kidney disease (ckd)?

Conditions: Chronic Kidney Disease

Summary: this study is looking to improve the safety of patients with chronic kidney disease via education provided on a mobile tablet. this study will additionally examine if electronic tools, such as mobile tablets, can help.

individuals with ckd are at risk for adverse safety events, yet little is known regarding the utility of health information technology (it) educational tools to reduce these events. the results of this project will be invaluable in gaining a better understanding of the limitations and potential for use of a patient-centered mhealth patient safety educational intervention in high-risk individuals with ckd. the study will evaluate the perceived ehealth literacy of patients with ckd and its relation to medication errors in the cric cohort. the hypothesis is that a novel mhealth-based patient safety curriculum designed to address a wide-range of e-literacy will be effective in attenuating the identified digital divide adversely affecting many ckd patients, and will reduce adverse safety events common in this population. study aims: 1. examine the association between surveyed perceived e-literacy and medication errors in individuals with ckd hypothesis 1: medication error rates will be higher among cric participants with low ehealth literacy. 2. assess the acceptance and feasibility of a novel mhealth-based patient safety curriculum to improve patient safety risk knowledge among individuals with ckd and determine its efficacy in increasing patient safety risk awareness. hypothesis 2a: a low literacy mhealth patient safety curriculum will improve patient safety risk awareness among high risk individuals with ckd. hypothesis 2b: medication error rates will be higher among cric participants with low patient safety risk awareness.

Eligibility criteria:
inclusion criteria: * enrolled in chronic renal insufficiency cohort (cric) study. exclusion criteria: * not enrolled in chronic renal insufficiency cohort (cric) study.
functional electrical stimulation for hemiplegic cerebral palsy

Conditions: Hemiplegic Cerebral Palsy

Summary: the purpose of this study is to evaluate how a functional electrical stimulation (fes) device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy walk and perform other functional activities. the investigators expect to find that wearing the functional electrical stimulation device will improve walking and other functional activities of children with hemiplegic cerebral palsy. participants will be trained in use of the device and will be required to wear it daily for 3 months. each participant will be evaluated before beginning the intervention and after completing the intervention. this study will provide important information regarding the benefits of this treatment intervention in children with hemiplegic cerebral palsy.


Eligibility criteria:
inclusion criteria: * diagnosis of hemiplegic cerebral palsy * gross motor function classification system (gmfcs) i or ii * age 6-17 years inclusive * demonstrate foot drop during gait without wearing ankle foot orthosis * tolerance to neuroprosthesis stimulation * physician referral to participate in intervention * passive dorsiflexion to at least neutral with knee extended * available to travel to and from study visits * ability to follow instructions and cooperate with study protocol * caregiver reads and understands english * exclusion criteria: * any metal implants containing electrical circuitry * continuous regular use of neuroprosthesis stimulation previous to study enrollment * previous orthopaedic procedure involving tibialis anterior muscle at any time * previous orthopaedic procedure to affected limb in the last year * botulinum toxin administered within the past 3 months, or plans for such treatment during the course of the study * any condition that pi feels would limit ambulatory progress (e.g. arthritis, uncontrolled seizures)

Keywords: hemiplegia, cerebral palsy, neuroprosthesis, children
sustain switch: a research study to compare two dose schedules of semaglutide taken once weekly in people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. the study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. people taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. participants will inject semaglutide under the skin once a week, any time of the day. when the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. the study will last for about 24 weeks. participants will have 9 visits and 1 phone call with the study doctor. at 9 visits participants will have blood taken and at 2 visits they will have eye examination done. women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. women who are able to get pregnant will be checked 10 times for pregnancy via urine tests.


Eligibility criteria:
inclusion criteria: * male or female, age 18 years or older at the time of signing informed consent. * diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening. * the need and willingness to change prior glp-1 ra treatment to once-weekly semaglutide s.c., as assessed by the investigator. * hba1c of 6.5-10% (48-86 mmol/mol) (both inclusive). * treatment with any therapeutic dose of glp-1 ra other than once-weekly semaglutide s.c., as defined in the local label, with or without oads (metformin, dpp-4 inhibitor, su, glinide, thiazolidinedione, sglt-2 inhibitor or alpha-glucosidase inhibitor). all doses of antidiabetic treatments should have been stable for at least 90 days prior to the day of the screening, at investigator's discretion. exclusion criteria: * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes. * renal impairment measured as estimated glomerular filtration rate (egfr) value of less than 30 ml/min/1.73 m2 according to chronic kidney disease epidemiology collaboration (ckdepi) creatinine equation as defined by kdigo 2012 classification. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination