Kornimate/medical-research-clean huggingface dataset:
effect of sleep deprivation on cognitive function among cardiology fellows

Conditions: Wellness; Burnout; Sleep Deprivation; Executive Function

Summary: a reliable method for monitoring sleep, stress, and burnout among cardiology fellows is critically needed. to address this gap, our team aims to utilize the cost-effective whoop strap 4.0 wearable device to continuously capture stress-relevant physiologic data (i.e., sleep hours, heart rate variability, respiration rate, resting heart rate) among up to 21 cardiology fellows thomas jefferson university hospital for 6 months.

conventional methods of qualifying personal wellbeing are limited by poor insight about the emotional and behavioral corollaries of stress and burnout (e.g., depersonalization, sleep alterations, heart rate variability). while self-care is often the preferred option for those coping with stress or burnout in challenging situations, it may be the only option in low-resource settings with limited access to professional management. similarly, many healthcare workers and trainees acknowledge that self-care is a critical component to overall wellbeing, yet they also admit that multiple barriers interfere with the effectiveness of this practice. first, self-care interventions can only be effective if impacted persons recognize the need for interventions, act on that need, and learn which methods are effective on an individual basis. furthermore, testing modalities (e.g., hormonal assays, polysomnography, electrophysiology) for stress and its downstream syndrome of burnout not only are prohibitively expensive, but they also require significant time and cannot be broadly disseminated within reasonable limits. as such, approaches for monitoring parameters of wellness are critically needed, and if successful, those data can allow for streamlined mental health interventions for those completing fellowship training before symptoms of burnout escalate further. aim 1: to determine whether physiologic metrics of sleep and heart rate variability correlate with executive function metrics post 12- or 24-hour call in a 12-month period. hypothesis: less total sleep hours will correlate with lower scores on executive function testing (stroop test). aim 2: to determine the physiologic effects of sleep deprivation from 12- and 24-hour call on heart rate variability, rem sleep, deep sleep and respiratory rate, over a 12-month period. hypothesis: less total and restorative (rem and deep sleep) will correlate with lower executive function scores and higher call burden (frequency and duration) will be associated with a prolonged return to baseline in sleep metrics (total sleep, rem sleep, deep sleep, sleep consistency).

Eligibility criteria:
inclusion criteria: * cardiology fellows at thomas jefferson university hospital (pgy4-pgy6) * own a smart phone for bluetooth pairing with whoop strap 4.0 exclusion criteria: * allergies, contraindications, or unwillingness to wear a wrist device for the study period

Keywords: whoop strap 4.0 remote monitoring
flower print activity applied to the elderly in the nursing home

Conditions: Elderly; Gardening; Anxiety; Nursing Caries

Summary: this research will be carried out in order to determine the effect of the flower pressure activity applied to the elderly in the nursing home on the anxiety levels of the elderly.

this research will be carried out in order to determine the effect of the flower pressure activity applied to the elderly in the nursing home on the anxiety levels of the elderly. hypotheses h0 = flower pressure activity applied to the elderly in the nursing home does not affect the anxiety level of the elderly. h1= flower pressure activity applied to the elderly in the nursing home reduces the anxiety level of the elderly.

Eligibility criteria:
inclusion criteria: * has no physical handicap that may hinder the activity of flower printing, * no vision or hearing loss that may hinder the activity of flower printing, * open to communication and cooperation, * the elderly who volunteer to participate in the study will be included in the study. exclusion criteria: * have a serious medical disability, * having a serious psychiatric diagnosis, * severely demented and * the elderly who do not want to continue the research will be excluded from the research.

Keywords: gardening, floral print, elderly, anxiety, nursing
long-term safety and tolerability of cariprazine for bipolar i disorder

Conditions: Bipolar I Disorder

Summary: the objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar i disorder.


Eligibility criteria:
inclusion criteria: * patients who have provided informed consent prior to any study specific procedures. * patients currently meeting the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for bipolar i disorder as confirmed by the structured clinical interview for diagnostic and statistical manual of mental disorders, fourth edition (scid). * patients who experienced a manic or mixed episode that required treatment within the past 12 months. * patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ecg). exclusion criteria: * patients with a dsm-iv-tr diagnosis of an axis i disorder other than bipolar i disorder.

Keywords: mania acute mania bipolar i disorder
double-blind, randomized, placebo-controlled study evaluating efficacy and safety of igpro20 in post-covid-19 pots

Conditions: Post-COVID Postural Orthostatic Tachycardia Syndrome

Summary: this is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics (pk) of repeat doses of igpro20 in participants with post sars-cov-2 infection 2019 postural orthostatic tachycardia syndrome (post-coronavirus disease 2019 \[covid-19\] pots \[post-covid-pots\]).


Eligibility criteria:
inclusion criteria: 1. provide written informed consent and be willing and, in the opinion of the investigator, able to adhere to all protocol requirements. 2. males and females aged ≥ 18 at the time of providing written informed consent. 3. diagnosis of post-covid pots, defined by both a preceding covid-19 infection based on confirmed historical documentation and onset of pots symptoms developing within 4 months after covid-19 infection as defined per consensus criteria. 4. compass-31 score of at least 40 at the screening visit. 5. positive confirmatory standardized standing test (ie, hr increase of ≥ 30 bpm \[≥ 40 bpm for participants aged 18 to 19 years\] within 10 minutes in the absence of orthostatic hypotension) at the screening visit. exclusion criteria: 1. treatment with immunoglobulin g (igg) or plasmapheresis within 12 weeks before screening 2. symptoms and / or diagnosis of or receiving treatment for pots before covid-19 infection 3. prior diagnosis of or receiving current treatment at screening for the following conditions (unless onset was related to the inciting pots-associated covid-19 infection): certain neurologic, autoimmune, endocrine, cardiac, or other disorders, and pre-existing psychiatric disorders 4. presence of active infections, including human immunodeficiency virus infection, hepatitis b, hepatitis c, active sars-cov-2 infection, or any uncontrolled systemic infection

Keywords: pots
improving in-hospital stroke service utilisation in china

Conditions: Thrombolytic Therapy; Acute Stroke; Door to Treatment Time; Quality Improvement

Summary: a cluster randomised controlled trial will be conducted, using hospital as randomisation unit. hospitals in zhejiang province, china, will be randomised into two arms (1:1): an intervention arm and a control arm. hospitals in the intervention arm will receive a multi-components intervention based on the behaviour change wheel model, whereas hospitals in the control arm will receive no intervention and maintain existing care. the randomisation will be conducted after one-year baseline data collection. the following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, thrombolysis patient number, and percentage of patients receiving thrombolysis within 60 minutes of stroke onset. hospitals with no stroke centre or with \<20 cases received thrombolysis per year will be excluded from the study. the primary outcome will be difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage (post-intervention).


Eligibility criteria:
inclusion criteria: * ais patients receiving ivt within 4.5 hours exclusion criteria: * patients who are not willing to attend this trial
study of ebi-005 in dry eye disease (ded)

Conditions: Dry Eye

Summary: this is a randomized, double masked study designed to evaluate the safety of ebi-005 5 mg/ml topical ophthalmic solution given three times daily (tid) compared to vehicle-control over a one year period in subjects with dry eye disease (ded). approximately 188 subjects will be enrolled to either ebi-005 or vehicle at up to 15 centers in the united states (us) and canada.


Eligibility criteria:
key inclusion criteria: 1. have a history of dry eye disease (ded) in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 6 months prior to visit 1 2. are willing and able to follow instructions and can be present for the required study visits for the duration of the study key exclusion criteria: 1. have an ocular condition that could confound study assessments (ocular infection, herpetic or neurotrophic keratitis, steven-johnson syndrome, etc) 2. have had penetrating intraocular surgery within 12 months prior to visit 1 3. be unwilling to comply with the study requirements

Keywords: ded disease
medico-economic interest of single-use ancillary efficiency® in fitting a gmk® total knee arthroplasty (tka)

Conditions: Knee Arthropathy

Summary: clinical studies on single-use ancillaries are still few; medico-economic benefits have to be assessed regarding their design and use. a foreseeable increase in the number of surgeries in the future, tends to change the techniques and consequently to question the medico-economic context. single-use ancillaries attempt to provide solutions to today's imperatives and could be relevant from a global medico-economic point of view. for the moment, the conventional ancillaries for tka are reused after sterilization. the objective of the study is to improve the fluidity of the intervention process with cost control.

after validation of the inclusion criteria, the surgeon will perform the randomization (1:1): single-use ancillary group or conventional ancillary group. only the medical team and the block staff will be informed about the ancillary group, not the patient. the use of the single-use ancillary does not induce any modification of the surgical technique for fitting a tka. the surgical approach is unchanged and is specific to the surgeon. the appearance and use of the single-use ancillary are similar to the conventional ancillary except for the materials used for their design. please note that a preliminary training at the beginning of the study will be carried out with the different investigators so that they can handle the different medical devices. in total, 48 participants will be randomized. the medico-economics assessments will be performed for 20 patients (10 per group) by micro-costing to evaluate the preoperative, intraoperative and post-operative costs : reconditioning time, sterilization and transport time, preparation time and duration of intervention. the qualitative score of subjective assessment of the operator's perception of the ancillary measured during the intervention. the participants will evaluate their qol by completing a questionnaire 3 month and 12 month postoperative. the safety parameters will also be collected.

Eligibility criteria:
inclusion criteria: * patient with gonarthrosis or inflammatory arthrosis of the knee leading to surgical indication for total knee arthroplasty * informed patient, able to understand the information, not opposing to participate this protocol * patient affiliate to social security exclusion criteria: * extra-joint deformation needing bone associated gesture * preoperative active or suspected infection * local evolutive tumoral pathology * medical history with bone gesture on concerned knee * patient unable or refusing to give his consentement * pregnant woman or in age to be pregnant without use any effective contraceptive method * patient under maintenance of justice, tutelage or legal guardianship) * presence of any family, sociological, political or geographic situation able to interfere with the protocol
prospective study into the performance of the microphage s. aureus/mssa/mrsa test direct from blood culture positives

Conditions: Bacteremia

Summary: direct in-vitro identification of s. aureus, methicillin-sensitive s. aureus (mssa), and methicillin-resistant s. aureus (mrsa) from positive blood cultures by microphage's bacteriophage-based diagnostic platform, two gold-standard reference methods, and two predicate devices with similar indications for use.

this is a multi-center, fda clinical study designed to investigate the safety and performance of the microphage s. aureus/mssa/mrsa test direct from blood culture positives. informed consent is not anticipated, as this is a laboratory performance study with no patient intervention. the microphage test will be compared to site standards of care, market-available rapid tests, two predicate tests, and two disk diffusion tests for antimicrobial susceptibility. the study will last approximately 4-6 months (bactec), dependent on the accrual rate of each institution. this study is designed to support the following product indications for use: the microphage s. aureus/mssa/mrsa blood culture test is a qualitative in vitro diagnostic test for the rapid identification of staphylococcus aureus and determination of methicillin susceptibility (mssa) or methicillin resistance (mrsa) directly from positive blood cultures. the test uses bacteriophage amplification to rapidly and phenotypically identify the presence of s. aureus and assess the response of the target organism to cefoxitin as an analog to methicillin. this test is performed on positive blood cultures. subculturing of positive blood cultures is necessary for further susceptibility test determinations. results of the study analysis will be in the form of descriptive statistics (mean, median, standard deviation, frequencies) for all study variables. associations among variables will be presented using correlation coefficients, as well as odds ratios and parameter estimates from multivariable regression (linear and logistic) where applicable.

Eligibility criteria:
inclusion criteria: * blood culture positive samples from subjects aged 18+, with any of the following bottle types: * bd bactec standard aerobic and anaerobic, * bd bactec plus aerobic and anaerobic, * completion of the microphage test protocol on the sample. exclusion criteria: * samples from subjects under 18 years of age, * samples from any other not included bottle types, * samples from blood culture positives over 24 hours from alarm, * samples deemed contaminated, * mislabeled / misidentified samples or data without documented corrections, * violations and/or deviations from the microphage test protocol and/or other included test protocols under study.

Keywords: staphylococcus aureus methicillin resistant mrsa mssa blood culture diagnostic
the pharmacokinetics of a single large dose of vitamin d3

Conditions: Vitamin D Deficiency

Summary: when people eat a meal, some, but not all of the calcium in that meal is absorbed, that is, moved into the bloodstream. when the skin is exposed to sunlight during summer months, vitamin d is made there and then modified into more active forms by the liver and kidneys. these more active forms of vitamin d improve calcium absorption. many adults living in the u.s. have little or no sun exposure and are low in vitamin d. a single dose of 100,000 iu of vitamin d3 has been used both as empiric treatment for vitamin d deficiency as well as in controlled trials without risk of raising blood calcium to dangerous levels.this study is to determine the serum levels of vitamin d and 25-hydroxyvitamin d (vitamin d after it has been modified by the liver) that can be expected when vitamin d3 is given as a single oral dose of 100,000 iu.

the group receiving the supplement will be scheduled for short visits to our research center at baseline and days 1,3,5,7 and then weekly for 3 weeks and then every other week for 6 visits (total 14 visits in 4 months). the group not receiving supplement will be scheduled for short visits at baseline and in 4 months. at the beginning of the study we will measure your height, weight, skin color, and draw blood to measure your blood levels of vitamin d, 25-hydroxyvitamin d, calcium and parathyroid hormone. at each visit we will draw blood to measure your blood levels of vitamin d and 25-hydroxyvitamin d. there will be fourteen blood draws for a total of 280 cc of blood drawn (about 4 teaspoons drawn each time) in the supplemented group. there will be 2 blood draws in the group not receiving supplements for a total of 60 cc of blood drawn (about 4 teaspoons drawn each time).

Eligibility criteria:
inclusion criteria: * healthy with limited sun exposure of less than 10 hours per week and daily milk consumption of less than 0.47 l (16 oz.). exclusion criteria: * those with granulomatous conditions, liver disease, kidney disease, or diabetes and those taking anticonvulsants, barbiturates, or steroids in any form.

Keywords: vitamin d cholecalciferol 25-hydroxyvitamin d
entecavir to taf switch

Conditions: Hepatitis B

Summary: a research study to observe the safety, efficacy and tolerability of switching from entecavir (etv) to tenofovir alafenamide taf in patients with chronic hepatitis b


Eligibility criteria:
inclusion criteria: * subjects, adult male and female ≥18 years of age with chronic hepatitis b with or without compensated cirrhosis * maintained on entecavir for a minimum of 48 weeks * viral suppression (hbv dna \<20 iu/ml) for a minimum of 12 weeks prior to entry are eligible for this study. * estimated creatinine clearance ≥ 50 ml/min (using the cockcroft-gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation. exclusion criteria: * subjects with known poor or non-compliance * subjects with co-infection with hcv or hiv subjects with decompensated cirrhosis and hcc will be excluded to participate in the study. * pregnant women and those who wish to become pregnant during the course of the study.
dermal hiv-1 immunization during anti-retroviral therapy followed by repeated treatment interruptions

Conditions: HIV-1

Summary: in this study, the investigators evaluated a therapeutic hiv-1 dna vaccine administered with a novel topical application method to 12 chronically hiv-infected cart treated patients. the hiv dna plasmids used in this study encode for envelope gp160 of hiv-1 subtypes a, b and c, rev b, gag a and b and reverse transcriptase (rt) b. the patients were randomly assigned to three groups; group 1 (n=4) were immunized six times with 0.4 mg of hiv dna plasmids topically, group 2 (n=4) were immunized six times with 0.4 mg of hiv dna plasmids topically and treated with 500 mg of hydroxyurea daily until visit 10, group 3 (n=4) four patients received placebo. the immunization was performed during three cycles of 7 weeks of cart followed by four weeks of therapy interruption. after the last cycle of cart the patients were maintained on a definitive treatment interruption until cd4+ t cell counts dropped below 350/ mm3 at two time points. cellular and humoral immune responses, viral load and cd4+ t a cell count was analysed throughout the study.


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 60 years 2. female, who is documented infertile or in menopause since at least 1 year, or male, who are willing not father a child for the duration of the study. 3. hiv infection detected by two serological and/or hiv plasma rna tests 4. on haart for at least 6 months with less than 50 copies/ml of plasma hiv-1 rna at two determinations over 3 months 5. current cd4 count above 400 6. cd4 count nadir \>200 7. viral isolate pre art available is preferable but not mandatory 8. willing to consider stopping haart repeatedly. 9. willing to conform to a low alcohol intake (maximum of one glass per day) 10. able to tolerate didanosine and hydroxyurea 11. willing to change their haart to exclude nnrti and stavudine 12. able to give informed consent 13. availability for follow-up for planned duration of the study exclusion criteria: 1. patients with ongoing infection(s) other than hiv. 2. prior or current pancreatitis or history of alcohol abuse. 3. ongoing neuropathy and history of more than grade 1 neuropathy. 4. history of mutations to more than one class of anti-retroviral drugs or switched drugs more than once due to failure. 5. sun or solarium exposure at the immunizing sites one month before or during the trial. 6. cortisone treatment, systemic or local at the immunizing sites, one month before or during the trial. 7. patients with signs of autoimmune diseases 8. patients with creatinine \> 2mg/dl, hb \ 5x upper limit of normal 9. patients on any immune modulating or investigational drug 10. anamnestic allergy to kanamycin, plasmid gene products