Kornimate/medical-research-clean huggingface dataset:
intensive education versus usual education of patients for improving guideline directed medical therapy (gdmt) prescription in heart failure with reduced ejection fraction

Conditions: Heart Failure; Patient Acceptance of Health Care

Summary: the goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (gdmt) of heart failure with reduced ejection fraction. the main question that our study aims to answer is if patient education can improve the adherence to gdmt in heart failure with reduced ejection fraction. participants will receive educations about gdmt benefits in 1,3 and 5 months after discharge from hospital.

this is a randomized clinical trial assessing the possible benefit of post-discharge education on the extent of guideline directed medical treatment for heart failure with reduced ejection fraction. patients that are admitted to medical facilities of the medstar health, baltimore will be screened and if consented, they will all get an initial inhouse face to face education, and upon discharge, they will be randomized to the control group and intervention group. the latter will get more educations via phone-call sessions at 1, 3 and 5 months post discharge. the educational sessions will include educating the benefits of gdmt, reviewing the components of gdmt and their possible side effects, performing medication reconciliation, inquiries about reasons not getting the medications and encouraging adherence to clinic visits and requesting the treating providers for gdmt optimization. there will be no formal prescription or change of medication during the educational sessions. gdmt use will be assessed in all patients after 6 months according to gdmt score by the heart failure collaboratory.

Eligibility criteria:
inclusion criteria: * patients diagnosed with heart failure reduced ejection fraction (ef≤40%) * age \>18 years * able to consent for enrollment. * hospitalized at one of the medstar facilities (inpatient) exclusion criteria: * pregnancy * patient with stage d heart failure candidates for advanced therapies or on home inotropes or receiving hospice service * patients with advanced organ failure (end stage cancer, advanced dementia, meld (model for end-stage liver disease) score \> 30, gfr (glomerular filtration rate) \<25) in whom gdmt is futile * patients with heart failure collaboratory score (hfcs) of 9

Keywords: heart failure with reduced ejection fraction patient education
a 24-hour pharmacokinetic determination of bg00012 after single-day oral administration in subjects with ms

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: to establish a pharmacokinetic (pk) profile of bg00012, as measured by its primary metabolite, monomethyl fumarate (mmf), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (rrms), with a variety of baseline demographic characteristics.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 55 years old, inclusive, at the time of informed consent. 2. have a confirmed diagnosis of rrms according to mcdonald criteria #1-4. 3. be ambulatory. exclusion criteria: 1. primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (prms). 2. history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than ms), dermatologic, psychiatric, renal, oncologic, anaphylaxis or other major diseases, as determined by the investigator. 3. current enrollment in any other drug, biologic, or device study or treatment with another investigational drug within 6 months or 5 half-lives of the investigational product, whichever time period is longer. 4. serious infection (e.g., pneumonia, septicemia) within the 2 months prior to day -1. 5. pregnant or nursing women. other protocol-defined inclusion/exclusion criteria may apply.
retrospective study of carebot ai cxr performance in preclinical practice

Conditions: Artificial Intelligence; Lung Diseases; Pneumothorax; Pleural Effusion; Cardiomegaly; Lung Cancer; Pulmonary Edema; Consolidation; Pneumonia; Atelectasis; Hilar Calcification; Fracture Rib

Summary: the purpose of this study is to describe the design, methodology and evaluation of the preclinical test of carebot ai cxr software, and to provide evidence that the investigated medical device meets user requirements in accordance with its intended use. carebot ai cxr is defined as a recommendation system (classification "prediction") based on computer-aided detection. the software can be used in a preclinical deployment at a selected site before interpretation (prioritization, display of all results and heatmaps) or after interpretation (verification of findings) of cxr images, and in accordance with the manufacturer's recommendations. given this, a retrospective study is performed to test the clinical effectiveness on existing cxrs.

the performance of the trained and internally validated carebot ai cxr software is tested on a set of 127 cxr images from target population. this is compared to common clinical practice, i.e., image assessment by a radiologist in a hospital. patients may have a variety of findings; at this stage of the evaluation, an abnormal finding is considered to be an abnormality in any of the defined classes. false negative images incorrectly predicted by carebot ai cxr software result in a clinical impact determination. to collect the cxr data for retrospective study, investigators addressed a municipal hospital in the czech republic that provides healthcare services to up to 130,000 residents of a medium-sized city (approximately 70,000 inhabitants) and the surrounding area. 127 anonymized cxr images were collected between august 15 and 17, 2022, and subsequently submitted to five independent radiologists of varying experience for annotation. the selected radiologists were asked to assess whether the cxr image shows any of the 12 pre-selected abnormalities. pediatric cxr images (under 18 years of age), scans with technical problems (poor image quality, rotation), and images in lateral projection were excluded from the dataset.

Eligibility criteria:
inclusion criteria: * hospital patients who were referred for chest radiography between august 15 and 17, 2022. exclusion criteria: * pediatric cxr images (under 18 years of age) * scans with technical problems (poor image quality, rotation) * images in lateral projection
perfusion pressure cerebral infarction trial (ppci)

Conditions: Embolic Stroke; Postoperative Cognitive Dysfunction

Summary: study hypothesis in cardiac surgery the volume of perioperative cerebral infarctions can be reduced by increasing mean arterial pressure (map) during the cardiopulmonary bypass procedure. brief study summary heart surgery using cardiopulmonary bypass (cpb) can be complicated by injury to the brain. previous studies using brain scans have reported small stroke-like lesions in up to 51% of patients after cardiac surgery. however, only 1-6 % of patients have permanent symptoms of severe brain damage. the majority of brain lesions seem to be caused by particulate matter (emboli) that wedge in blood vessels of the brain thereby compromising flow. in addition, insufficient blood flow to areas of the brain supplied by narrowed, calcified vessels may contribute. map during cpb usually stabilizes below the lower limit of cerebral autoregulation, which is accepted since sufficient total blood flow is guaranteed during cpb. the aim of the ppci trial is to investigate if increased map during cpb can prevent or reduce the extent of brain injury after cardiac surgery. a beneficial effect could result from reduced embolic injury through increased blood flow in collateral vessels and/or by increased blood flow in calcified arteries. 180 patients scheduled for cardiac surgery will be randomly allocated to increased map (70-80 mm hg) or 'usual practice' (typically 45-50 mm hg) during cpb, whereas cpb blood flow is intended equal and fixed in the two groups. patients are examined before and 3-6 days after surgery with magnetic resonance imaging (mri) brain scans, mental tests and by blood borne markers of brain injury. if higher map during cpb is beneficial, a change of practice can easily be implemented in the clinical routine.

trial design the ppci trial is a randomized, controlled, outcomes assessor and patient blinded, single-center superiority trial with two parallel groups in a 1:1 allocation ratio. the randomization will be stratified according to age (stratum 1 \< 70 years; stratum 2 ≥ 70 years) and type of surgery (stratum 1 - surgery involving the aortic and/or mitral valve; stratum 2 - surgery not involving these valves).

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age. * scheduled elective or subacute cardiac surgery with the use of cpb. * type of surgery either coronary artery bypass grafting (cabg) and/or heart valve surgery (provided that the valve prosthesis used is mri compatible). exclusion criteria: * a history of stroke. * a history of reversible ischemic deficits (duration of symptoms 24-72 hours) * a history of transitory ischemic attacks (duration of symptoms \< 24 hours) * diagnosis of neurodegenerative disorders such as alzheimers, multiple sclerosis etc.

Keywords: ischemic stroke embolic stroke postoperative cognitive dysfunction cardiac bypass surgery cardiac anaesthesia
the incidence of glistenings in the 2017 intraocular lenses made by alcon and abbott medical optics

Conditions: Cataracts; Visual Acuity Reduced Transiently; Loss of Visual Contrast Sensitivity; Functional Visual Loss

Summary: the purpose of this study is to seek academic/non-industry research funding support to independently investigate the incidence and density of lens glistenings in cataract patients who are implanted with the latest generations of intraocular lenses (iol) manufactured by alcon and amo medical optics.

glistenings are tiny, clear sparkling, fluid-filled microvacuoles that form within a lens after it has been placed in the eye. glistenings are seen in all lenses but certain lenses develop a higher number of glistenings than others. the effect of glistenings on patients' visual functioning is largely unknown. the occurrence of glistenings is in part related to the manufacturing technique. in 2013, manufacturers have claimed that recent improvements in manufacturing process have reduced the occurrence of glistenings. there is a lack of independent evaluation of this claim. we would like to assess independently: 1) how frequently do glistenings occur in patients implanted with the 2015 generation lenses? 2) is there a difference in glistening occurrence between lenses manufactured by alcon and abbott medical optics (amo) - the two largest companies in eye care products? two-hundred and seventy-six patients will be randomly assigned to receive alcon or amo lenses for their cataract surgery at the kensington eye institute (kei). after surgery, patients will be instructed to return for follow-up visits at 1 month, 6 months, 12 months and 18 months to assess for the occurrence of glistenings. if glistenings are observed at an earlier follow-up visit (e.g., the 6 month visit), patients will still be instructed to come for future visits so that changes in the glistenings over time can be observed. project time-line: months 1-8: participants recruiting, surgical operations, follow-up visits. months 9-24: follow-up visits, data entry, cleaning and analysis, early results presentation, manuscript preparation and final report.

Eligibility criteria:
inclusion criteria: * patients consulting 5 surgeons for cataract surgery in the surgeon's primary offices * patients aged 18 years or older * patients who signed the consent form exclusion criteria: * individuals who cannot understand english in either written or verbal form and do not have language assistance available (e.g. from family members, friends) * patients with co-existing condition of corneal disease * patients with co-existing condition of uveitis * patients with co-existing condition of optic nerve disease * patients with co-existing condition of macular disease * patients with co-existing condition of diabetes * patients with co-existing condition of severe glaucoma (i.e. c/d ratio \>=0.9 and the patient is on glaucoma treatment) * patients with prior refractive surgery * patients with complications of cataract surgery occurred during or after surgery

Keywords: cataract surgery intraocular lens glistenings
ejaculation preservation after laser enucleation prostate

Conditions: Prostate Hyperplasia

Summary: a multicentre randomised controlled trial evaluating the benefit of median lobe preservation on the incidence of retrograde ejaculation during prostate enucleation by holep.

the main objective of the study is to compare the incidence of retrograde ejaculation at 6 months in patients undergoing holep surgery for prostatic adenoma according to two randomized surgical techniques: conventional surgical procedure of removal of the 3 prostatic lobes versus preservation of the median lobe.

Eligibility criteria:
inclusion criteria: * patients aged 40 years and older who have signed their consent to participate in the study * patient with preserved cognitive functions * patient with bph characterised by an ipss score ≥ 12, a qmax ≤ 15 ml/s and an ultrasound-assessed prostate volume between 40 and 150 cc * patient for whom an indication for prostatic resection by holep has been made, * a patient who is sexually active and willing to maintain sexual activity after surgery * patient affiliated to a social security system or beneficiary of such a system exclusion criteria: * history of prostate surgery or prostate radiotherapy * urethral stenosis * cancer or a history of cancer * patient with a life expectancy of less than 2 years * patient refusing partial surgery * history of vasectomy, erectile dysfunction or ejaculation * mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol * patient under court protection, guardianship or curatorship * patient already included in another therapeutic study protocol or having participated in another trial in the previous three months
immuno-bridging study of covid-19 protein subunit recombinant vaccine

Conditions: COVID-19

Summary: observer-blind, randomized, active-controlled prospective intervention study

this trial is randomized, prospective intervention study. a total of 4,050 subjects (covid-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. the subjects will be divided into three study subsets, namely main study i, main study ii, and exploratory study: main study i for immunogenicity and safety evaluation, main study ii for safety evaluation, and exploratory study for cellular immunity evaluation, with trial design as follow : * main study i, exploratory study subset: observer-blind, randomized, active-controlled prospective intervention study * main study ii: open-label, randomized study to evaluate safety i

Eligibility criteria:
inclusion criteria: 1. clinically healthy subjects aged 18 years and above. 2. subjects have been informed properly regarding the study and signed the informed consent form. 3. subjects will commit to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: 1. subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. history of vaccination with any covid-19 vaccine. 3. history of covid-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment. 4. evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 5. women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 6. history of uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 7. history of blood disorders contraindicating intramuscular injection. 8. patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.) which according to the investigator might interfere with the assessment of the trial objectives. 9. history of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (\> 2 weeks)). 10. history of uncontrolled epilepsy or other progressive neurological disorders, such as guillain-barre syndrome. 11. subjects receive any vaccination (other than covid-19 vaccine) within 1 month before and after ip immunization. 12. subjects plan to move from the study area before the end of study period.

Keywords: covid-19 vaccine healthy population naive participants
clinical efficacy of diazepam after whiplash

Conditions: Whiplash Injuries; Whiplash Injury of Cervical Spine

Summary: whiplash injury is very common and lot of patients which suffered the injury have chronic symptoms despite different treatment options. one of main symptoms include muscle spasm and pain caused by neck movement. diazepam is a well known drug which can be used to treat muscle spasms. the aim of this study is to determine whether short term diazepam therapy can have positive effect on long term outcomes after whiplash injury.

this randomized, assessor-blinded study was conducted on patients presented due to a cervical spine injury caused by a traffic accident in the previous 48 hours from 1st january 2020 to 31st december 2020. all the patient which were included in this study were divided into 2 groups: group a, the test group, and group b, the control group. all patients signed the consent to participate in the study prior to randomization. during the initial examination a detailed history was taken and it included visual analog pain scale (vas). on follow up examinations 7 days, 6 weeks and 6 months after the injury, all patients completed neck disability index (ndi), whiplash disability questionnaire (wdq) as well as visual analog pain scale (vas). any patient which didn't complete all the follow up examination was excluded from the study.

Eligibility criteria:
inclusion criteria: * patients who suffered cervical spine injury caused by a traffic accident in the previous 48 hours exclusion criteria: * younger than 18 years of age; older than 70 years of age; the presence of associated injuries; previous surgery on the cervical spine; previously diagnosed arthrosis of the cervical spine; the presence of a malignant process and previous cervical spine injuries; history of diazepam allergy

Keywords: whiplash cervical spine neck whiplash injury muscle spasm diazepam muscle strain
tracking and exploring the source of viral rebound

Conditions: Hiv

Summary: phylogenic analysis of viruses hosted in marker positive reservoir cells including cd32a+ cd4 t lymphocytes and rebounding viruses after treatment interruption


Eligibility criteria:
inclusion criteria: * - age\>18year old * nadir cd4\>200/mm3 * cd4/cd8 ratio\> 0.5 * continuous antiretroviral therapy for more than 2 years * plasma human immunodeficiency virus (hiv) 1 ribonucleic acid (rna) \<50 copies/ml in the last 2 years * viral load (vl)\<20copies at inclusion * patients who are willing to participate and who understand the trial (particularly, the obligation to have protected intercourse during the study). * informed consent * short half-life treatment * health insurance * a subset of cd4 (t4cells) express cd32a. exclusion criteria: * - acquired immune deficiency syndom (aids) * pregnancy * human immunodeficiency virus (hiv)-2 co infection * thrombopenia * neurological events during primary infection * hepatitis b + (hbv+) * hepatitis c + (hcv+) * cancer during the last 5 years. * life expectancy \< 12 months * autoimmunity * acute infectious disease in the last 60 days. * hemoglobin\<7g/dl * glomerular filtration \< 60ml/min * refusing protected intercourse * risk of hiv transmission * psychiatric disorders. * alcool and drug abuse * involvement in another clinical trial evaluating a therapeutic. * being under tutorship * being deprived of liberty

Keywords: hiv reservoirs hiv persistence viral rebound
effects of psilocybin in concussion headache

Conditions: Post-Traumatic Headache

Summary: the purpose of this study is to investigate the effects of oral psilocybin in post-traumatic headache. subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days approximately 14 days apart. subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. blood samples will be drawn at various timepoints to measure levels of inflammatory peptides.


Eligibility criteria:
inclusion criteria: * diagnosis of post-traumatic headache * typical pattern of headache attacks with approximately two attacks or more weekly * attacks are managed by means involving no more than twice weekly triptan use exclusion criteria: * axis i psychotic disorder (e.g. schizophrenia, bipolar i, depression with psychosis) * axis i psychotic disorder in first degree relative * unstable medical condition, severe renal, cardiac or hepatic disease, pacemaker, or serious central nervous system pathology * pregnant, breastfeeding, lack of adequate birth control * history of intolerance to psilocybin, lsd, or related compounds * drug or alcohol abuse within the past 3 months (excluding tobacco) * urine toxicology positive to drugs of abuse * use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine) within 5 half-lives of test days * use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks * use of antidepressant medication (i.e. tca, maoi, ssri) in the past 6 weeks * use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks

Keywords: psilocybin