Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of the spikogen covid-19 vaccine in children aged 5 to <12 years and 12 to <18 years compared with adults aged 18 to 40 years

Conditions: COVID-19

Summary: this was a non-randomized, three-armed, open-label, parallel-group, non-inferiority trial designed to compare the immunogenicity and safety of the spikogen covid-19 vaccine in children aged 5 to \<12 years and 12 to \<18 years with adults aged 18 to 40 years. children aged 12 to \<18 years and adults received 25 µg of the recombinant protein together with 15 mg of advax-sm. children aged 5 to \<12 years received a half-dose of the adjuvanted vaccine. the injection was given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. the vaccine immunogenicity was evaluated at 14 days after the second dose. solicited adverse events were recorded for 7 days after each vaccination. unsolicited adverse events were collected through one month after the second dose. safety monitoring was continued through six months after the second dose in children aged 5 to \<12 years and 12 to \<18 years.


Eligibility criteria:
inclusion criteria: * male or female between 5 and 40 years of age inclusive * willing and able to comply with all study requirements, including scheduled visits, interventions, and laboratory tests * healthy adults or adults in a stable medical condition, defined as not being hospitalized within 3 months prior to the screening visit * females must not be pregnant or breastfeeding * children with a body mass index equal to or greater than the 3rd percentile for age and sex as per the world health organization child growth standards exclusion criteria: * subjects with signs of active sars-cov-2 infection at the screening visit. * subjects with epilepsy or a history of febrile seizures * subjects who receive immunosuppressive or cytotoxic medications. * subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products. * subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study. * subjects who have been vaccinated with any vaccine or vaccine candidate against sars-cov-2. * subjects who have received any vaccines within 28 days prior to the screening visit or intend to receive any vaccines up to day 14 of the study. * subjects who have any known bleeding disorders or, in the investigator's opinion, have any contraindications for an intramuscular injection. * subjects who have received any blood, plasma, or immunoglobulin products from 90 days prior to the screening visit or intend to receive during the study period. * subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion. * subjects who have donated ≥450 ml of blood or blood products within 28 days prior to the screening visit.

Keywords: covid-19 sars-cov-2 recombinant protein spike advax-sm advax vaccine adjuvant
prehospital provider training with augmented reality (ar)

Conditions: Hypoglycemia; Pediatric ALL

Summary: the goal is to evaluate the acceptance of augmented reality (ar) simulation as a learning modality for prehospital providers. the simulation itself is grounded in traditional best practices for simulation delivery and design as well as prior literature on simulation training for prehospital providers; the focus of this study is the participants' experiential interaction with ar and the simulation resources.


Eligibility criteria:
inclusion criteria: * trainees/ faculty working and/or volunteering at lpch/shc facilities as well as community based prehospital providers * 18 years and older exclusion criteria: * participants who do not consent * have a history of severe motion sickness * currently have nausea * history of seizures * are clinically unstable * currently using corrective glasses (not compatible with ar headset) * currently pregnant
ocular-vestibular biomarker identification for adhd

Conditions: ADHD - Combined Type; ADHD; ADHD Predominantly Inattentive Type; ADHD, Predominantly Hyperactive - Impulsive

Summary: this study intends to establish a relationship between oculovestibular eye tracking measures, measures of adhd, and medication prescribed for adhd.

this study will use a predictive visual tracking paradigm (syncthink eye-sync eye tracking paradigm) to dynamically capture the participants' attentional state. it will examine the validity of the eye tracking paradigm in identifying the disruption in attentional networks caused by adhd by examining the association between eye tracking performances and well-established standardized measures of adhd.

Eligibility criteria:
inclusion criteria: * men and women ages 6-70 seeking evaluation and treatment for adhd. exclusion criteria: * clinical diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, dyslexia, nystagmus and/or other major neurological condition. * clinical diagnosis of any of the following eye-sight abnormalities: uncorrected amblyopia, uncorrected myopia, uncorrected presbyopia, uncorrected farsightedness or uncorrected astigmatism. * psychiatric history with any of the following: * lifetime: clinical diagnosis of a psychotic disorder; bipolar disorder * last year: clinical diagnosis of major depressive disorder; ptsd; clinical diagnosis of substance abuse disorder; major anxiety disorder * use of a psychotropic medication * impairment of cranial nerves ii-vi * participants who receive a 'poor' or 'fair' eye tracking quality result on either their baseline or follow-up evaluations will be excluded from analysis. subjects may not repeat participation

Keywords: adhd eye-sync eye tracking oculomotor vestibular
efficacy and safety of oral bosentan in pulmonary fibrosis associated with scleroderma

Conditions: Pulmonary Fibrosis; Scleroderma, Systemic

Summary: clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ild) associated with systemic sclerosis (ssc), a condition for which no established efficacious treatment is available. the present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (pah) who class iii and iv, to a new category of patients suffering from ild associated with ssc.


Eligibility criteria:
main inclusion criteria: * systemic sclerosis diffuse or limited * significant interstitial lung disease on hrctscan * dlco \< 80% predicted * dyspnea on exertion * walk not limited by musculoskeletal reasons main exclusion criteria: * interstitial lung disease due to other conditions than ssc * end stage restrictive or obstructive lung disease * severe cardiac or renal diseases * significant pulmonary arterial hypertension * smoker (\> 5cig./day) * treatment with immunosuppressive, antifibrotic drugs, high dose corticosteroids (within 4 weeks of randomization)

Keywords: scleroderma fibrosing alveolitis build bosentan
albumin assisted diuresis in patients with cirrhosis and ascites

Conditions: Cirrhosis; Ascites Hepatic

Summary: a small, pilot proof-of-concept placebo-controlled trial to explore the effects of albumin on diuresis in patients with cirrhosis, ascites and lower extremity edema. we will additionally investigate albumin's effect on preventing neurohumoral activation, and acute kidney injury after diuresis.


Eligibility criteria:
inclusion criteria: * outpatient patients with decompensated cirrhosis with past or current ascites and persistent lower extremity edema despite oral diuretic titration * serum albumin of \< 3.5 g/dl * age \>=18 years old exclusion criteria: * patients with gfr \< 30ml/min/1.73 m2 * changes in oral diuretic regimen in the past 7 days (\*\*patients can enter the study after 7 days of the change) * large volume paracentesis (lvp) in the past 7 days (\*\*patients can enter the study after 7 days) * albumin infusion within the previous 14 days (\*\* patients can enter the study after 14 days) * spontaneous bacterial peritonitis in the past month * active variceal bleeding * current hepatic encephalopathy (\>= grade 2 based on west haven criteria) * co-administration of other diuretics such as hydrochlorothiazide (amiloride or eplerenone in place of spironolactone, and bumex/torsemide in place of furosemide are acceptable) * hypotension (mean arterial pressure \<65 mmhg, systolic blood pressure \<90 mmhg) * severe hyponatremia (sodium \<125 meq/l) * previous diagnosis of overt heart failure (systolic ef \< 50%) * baseline oxygen requirement * hypersensitivity to albumin preparations

Keywords: albumin cirrhosis ascites diuresis
surgical treatment of mild obstructive sleep apnea

Conditions: Sleep Apnea

Summary: obstructive sleep apnea (osa) is one of the most common sleep disorder. there are numerous conditions that are related to osa, such as diabetes, cardiovascular diseases, and metabolic syndrome. if the patient with osa have large tonsils, soft and largened uvula or flacid soft palate, one might benefit from operative treatment of osa. the aim of our study is to find out whether an operative treatment is effective in mild osa patients with carefully assessed anatomical predispositions. our ultimate goal is to evaluate the effects of operative treatment in mild osa itself and in the diseases related to osa. we measure the cardiovasculary functions, symptoms, postoperative recovery, antropometry, laboratory tests, the quality of life, the quality of sleep and the inflammatory system in sleep apnea before and after the surgery.


Eligibility criteria:
inclusion criteria: * age 18-65 * bmi \<35 * ahi 5-30 events/h * largened tonsils grade ≥1 exclusion criteria: * age \ 65 * bmi \>35 * ahi \ 30 * tonsil size \< 1 * severe nasal polyposis * pregnancy * chronic kidney, liver or thyroid disease * active treatment of osa of any kind
autonomic dysfunction and spinal cord stimulation in complex regional pain syndrome

Conditions: Complex Regional Pain Syndrome

Summary: to demonstrate that spinal cord stimulator has an effect on sympathetic function (the one that give us the fight and flight response). therefore, if the spinal cord stimulator has an effect on sympathetic function, the responses from crps patients to different stimuli will differ significantly pre and post scs implant. if crps patients exhibit autonomic, crps patients could be stratified according to their sympathetic function pre-implant. it is expected that patients with a moderate/mild form of autonomic dysfunction will have better outcomes with the scs.

currently the mechanisms of complex regional pain syndrome (crps) are poorly understood and stratification of either diagnosis or therapy is very weak. . there is a great need to develop and validate more objective methods to characterize and stratify crps that better diagnostic and therapeutic approaches are available. spinal cord stimulation (scs) has been used as the last resource to alleviate pain and re-establish function in crps patients. however, there is a disagreement over how it works. an underlying concept is that it works by modulating autonomic nervous system (ans) activity. therefore, ans parameters could be useful to stratify patients. our preliminary studies indicated that scs has also an effect on blood pressure regulation and improves the crps patients' response to valsalva maneuver -a test of autonomic function. the autonomic nervous system function in adult crps patients has not yet been studied. the only existing study of crps and autonomic function showed that 15% of the patients suffer from syncope and increased heart rate during upright position similar to same aged patients with postural tachycardia syndrome - a syndrome of autonomic dysfunction. it is unclear if autonomic dysfunction is present in crps patients because ans activity is altered by chronic pain or whether or not ans activity contributes to crps. therefore, we proposed to study the autonomic function in crps patients by standardized autonomic function and to evaluate the effect of the scs on autonomic function in crps patients before and after spinal cord stimulator implant. this is a 24 months study.

Eligibility criteria:
inclusion criteria: * crps patients meeting the inclusion criteria according to the international association for the study of pain task force will be included in the study. * age: 18 to 65. * disease duration of at least 6 months. * history of unsuccessful long lasting therapies: physical therapy, transcutaneous electrical stimulation and medication. exclusion criteria: * presence of current or past pulmonary, hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not related to crps. * anticoagulant therapy, cardiac pacemaker used. * pregnancy test for females is positive.

Keywords: rsd scs crps complex regional pain syndrome patients before undergoing spinal cord stimulator implant and under other treatments
t2mr pcr detection of eskape pathogens in patients with pyogenic spondylodiscitis and infective endocarditis

Conditions: Osteomyelitis; Vertebra; Endocarditis, Bacterial

Summary: our prospective observational study focuses on the rapid detection of etiologic agents of pyogenic spondylodiscitis and infective endocarditis using the t2 bacteria panel (t2biosystems). this diagnostic method combines polymerase chain reaction (pcr) and t2 magnetic resonance for detection of bacterial dna from whole blood samples. it detects six pathogens known by the acronym eskape (e. coli, s. aureus, k. pneumoniae, a. baumannii, p. aeruginosa, and e. faecium). in recent years, similar studies using the bacteria panel and candida panel have been performed in patients with bloodstream infections, leaving us with optimistic results.the aim of this study is to verify whether t2b can identify the etiologic agents of localized infections, specifically spondylodiscitis and endocarditis, with better sensitivity and specificity and shorter time to result compared to conventional diagnostics from blood culture. rapid detection of pathogen may reduce time to targeted pathogen-specific antibiotic therapy and subsequently improve outcomes, shorten the treatment and contribute to slowing the development of antibiotic resistance.


Eligibility criteria:
inclusion criteria: * diagnosis of spondylodiscitis or/and facet joint infection or/and sacroileitis * diagnosis of infective endocarditis * antibiotic treatment not received or not longer than 24 hours * ability to give informed consent exclusion criteria: * spine infection or/and endocarditis not confirmed * antibiotic treatment longer than 24 hours * inability to give informed consent

Keywords: spondylodiscitis endocarditis pcr t2bacteria panel mri
a survey to evaluate the cardiovascular risk status of subjects with pre-diabetes in hong kong

Conditions: Prediabetes; Cardiovascular Risk Factors

Summary: hypothesis: a high cardiovascular risk is present in subjects with pre-diabetes in hong kong chinese. the investigators plan to assess chinese subjects in hong kong who have pre-diabetes (impaired fasting glucose, ifg; or impaired glucose tolerance, igt) based on oral glucose tolerance test (ogtt) on their cardiovascular risk status such as obesity, hypertension and lipid profile.


Eligibility criteria:
inclusion criteria: * hong kong chinese with confirmed ifg or igt by ogtt exclusion criteria: * confirmed diabetic patients

Keywords: prediabetes (ifg, igt) hong kong chinese cardiovascular risk factors
cognitive and motor tasks in cerebral palsy

Conditions: Cerebral Palsy; Gait Disorders, Neurologic; Cognitive Orientation; Motor Activity

Summary: various gait deviations are observed in children with cerebral palsy. our aim was to determine the effect of cognitive task (ct) and motor task (mt) on gait in children with cerebral palsy (cp). 15 children with cp, between 9-15 years old, with communication function classification system (cfss) level i, with gross motor function classification system (gmfcs) and manual ability classification system (macs) level i-ii were included in the study. the gait with four different conditions (single gait, ct, mt and ct\&mt) was evaluated by kinovea video analysis method on a 10-meter course. results:

all children with cp were instructed to walk on the track under four different conditions: * single: walking without task at a self-selected speed * cognitive task (ct): walking while counting down rhythmically from 20 in threes * motor task (mt): walking while carrying an empty box * ct + mt: walking while carrying an empty box and counting down rhythmically from 20 in threes the task was explained to individuals by a physiotherapist. the individuals were not allowed to use orthosis during walking performance. running was not accepted. 30 seconds were given to take a break between tasks. the physiotherapist followed the individuals along the track in case of any falling. if the child was not able to complete the track (falling or need to rest), the evaluation was accepted uncomplete and was excluded from the database. the kinovea-08.15 software program was used to assess all of the outputs (images and videos) from the camera

Eligibility criteria:
inclusion criteria: * having been diagnosed with cp in the health committee * being between 9-15 years of age, having a mental level as "normal" (in terms of compliance with the exercises) * being in gross motor function classification system (gmfsc) level i-ii * being in manual ability classification system (macs) level i-ii * being in communication function classification system (cfss) level i (communication method is speech). exclusion criteria: * having a mental retardation * having severe vision impairment * underwenting botulinum toxin (botox) injection or surgery affecting lower extremities in the last 6 months.

Keywords: cerebral palsy cognitive task dual task paradigm motor task gait
study of the quadratus lumborum bloc in total hip arthroplasty: efficacy and safety

Conditions: Postoperative Pain; Total Hip Replacement

Summary: the purpose of this prospective research study is to determine the best way to manage post-operative pain after a total hip arthroplasty. currently, there is no standard of care for managing post-operative pain in these patients. the quadratus lumborum block (qlb) first described by blanco in 2007, is a promising technique in this indication: recently, there is a growing evidence for the use of the qlb as an alternative technique for pain management after hip surgery.

a sample size of 100 patients (50 per group) was calculated based on 20% reduction in morphine consumption with 0.05% significance and a power of 0.8. after ethical committee approval, eligible patients scheduled to have a fast-track total hip arthroplasty are screened during preoperative evaluation clinic. informed written consent will be obtained from all patients during pre-anesthesia visit the day before surgery (j-1). consenting patients will be randomized the day of surgery (j0) to undergo qlb with ropivacaine ("ropivacaine group") or normal saline ("saline group"). before general anesthesia, all patients will have a needle-insertion posterior to the quadratus lumborum muscle avec injection of either ropivacaine in the "ropivacaine group" or normal saline in the "saline group". after general anesthesia induction, dexamethasone and ketamine will be given to all patients.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical classification status (asa) i to iii * age ≥ 18 years * scheduled for fast-track total hip arthroplasty * written informed consent * patient covered by health insurance exclusion criteria * protected patients or patients incapable of giving written informed consent * pregnant or breastfeeding woman * vulnerable adult * contraindication for fast-track surgery * inability to comprehend or participate in pain scoring scales * allergy to study drugs * severe coagulopathy * chronic kidney disease with glomerular filtration rate (gfr) ≤ 30 ml/min (estimated by the cockcroft \& gault formula) * chronic pain (treated by nonsteroidal anti-inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants) * peripheral neuropathy
subantimicrobial doxycycline in acne

Conditions: Acne Vulgaris; Pediatrics

Summary: antibiotic resistance is a public health problem that worsens the more physicians prescribe standard dose antibiotics for acne. regardless of race, acne vulgaris is one of the most common dermatologic conditions among pediatric populations. as such, clinicians can make a large impact by practicing good antibiotic stewardship while still addressing the impact of acne on adolescents' self-esteem. subantimicrobial doxycycline maintains its anti-inflammatory effects while eliminating antimicrobial properties and associated risks of drug resistance. few studies, focused primarily on adults, have shown that subantimicrobial doxycycline is efficacious in treating acne from a physician standpoint. the investigators aim to investigate the patient experience of acne treatment with subantimicrobial dose doxycycline in the pediatric population.


Eligibility criteria:
inclusion criteria: * documented moderate to severe facial acne exclusion criteria: * other skin conditions on the face * previous antibiotic treatment for acne * use of antibiotics for any reason within the past month * use of new prescription regiment for acne within the last 3 months * positive pregnancy test in the clinic * cognitive impairments

Keywords: acne vulgaris doxycycline sub-antimicrobial pediatrics
exercise and endocannabinoids for brain and mental health

Conditions: Children; Adolescents

Summary: this study will explore how exercise affects brain chemicals called endocannabinoids, which may improve thinking skills and reduce feelings of stress, anxiety, and low mood in children and teens aged 9 to 17. participants will take part in a single 30-minute activity session, where they will be randomly assigned to one of three groups: 1. moderate-intensity exercise (walking or running on a treadmill at 50-70% of their maximum heart rate). 2. light stretching (gentle movements at less than 40% of their maximum heart rate). 3. seated meditation (relaxing without movement at less than 30% of their maximum heart rate). the investigators will measure endocannabinoid levels, thinking skills, and mood before and after the activity to see how these activities affect the brain and emotions.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and available for the duration of the study * 9-17 years of age * adolescent and parent/guardian are english-speaking, as study assessments are in english * right-handed exclusion criteria: * head injury * sensory (e.g., hearing) impairment * physical (e.g., motor, balance) impairment * physical disabilities * neurological disorders * any condition that would contraindicate blood draws

Keywords: exercise endocannabinoid anxiety meditation stretching