Kornimate/medical-research-clean huggingface dataset:
user experience of the osr m-1

Conditions: Covid19

Summary: the purpose of this observational study is to verify the user acceptance of the open standard respirator-model 1 (osr-m1) by clinicians through pre-trial survey and quantitative fit-testing and post-trial feedback surveys. this study will help to guide further design modifications and clarify quantities of employee populations that may benefit from elastomeric respirator use for the deployment of osr m1 air purifying respirators (aprs) in the wake health network.

the study team hypothesizes that the osr m-1 apr with national institute for occupational safety and health classification 99% airborne particle filtration (n99) will have increased fit and seal as well as user comfort and acceptance over disposable national institute for occupational safety and health classification 95% airborne particle filtration (n95) filter facepiece respirators (ffr). the study team is proposing to assess the acceptance and functional usability of the osr-m1 in wake forest baptist health system as a n95 disposable ffr alternative for improved protection and economy. 1. assess the effectiveness and causation of successful/unsuccessful fit testing of the osr m1 apr by measuring anthropometry of facial features and performing quantitative fit testing of clinicians. 2. determine usability, initial and long-term acceptance of the osr m1 apr relative to standard issue disposable ffrs through user survey and assessment.

Eligibility criteria:
inclusion criteria: * clinical staff who are issued and routinely wear n95 ffr or equivalent apr's are eligible. exclusion criteria: * participants unable to pass the fit testing will be excluded from the study. * anyone with a contraindication to wearing an n95 ffr (i.e. pregnancy, underlying medical conditions) will be excluded from the study.

Keywords: covid coronavirus respirator mask n99
safety and effectiveness of spiriva in copd (chronic obstructive pulmonary disease) patients under the real condition of usual practice

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to monitor the change in the health status of severe copd patients after the initiation of tiotropium therapy. this will be assessed by the physician's global evaluation of the patient's health status on a 8-point scale. this measure has been shown to correlate with a established standard measure of the patients health related quality of life. the primary analysis in this trial will only include patients not pre-treated with a long-acting beta-agonist to establish a clear efficacy signal in this patient population. as the reality of copd treatment nowadays is poly-pharmacy, a secondary analysis will analyse patients who are pretreated with long-acting bronchodilators to put the changes in the health status in a likely real world context. in parallel to these evaluations of the health status, the lung function response of the patients will be assessed to gain an established objective measure of treatment response.


Eligibility criteria:
inclusion criteria: 1. patients with confirmed diagnosis of copd according to the global initiative for chronic obstructive lung disease (gold; updated 2005). 2. patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication. 3. tiotropium bromide naïve patients. 4. patients with indication for tiotropium bromide according to taiwanese spiriva® label. exclusion criteria: 1. patients with contraindications to tiotropium bromide use (as per the spiriva® package insert). 2. known hypersensitivity to the active ingredient or to any of the excipients of spiriva®.
evaluation of the cardiovascular effects of the mas in the treatment of obstructive sleep apnea

Conditions: OSA

Summary: in this prospective trial 50 patients, diagnosed with moderate to severe obstructive sleep apnea (osa) (ahi \> 15/h sleep) will be included and treated with mandibular advancement devices (mad). these patients will undergo cardiovascular examination; echocardiography and 24h-blood pressure monitoring, on top of the normal clinical evaluation of osa patients. these cardiovascular examinations will take place before and during mad therapy.


Eligibility criteria:
inclusion criteria: * ahi \> 15 events/hour * no other active osa therapy in the 3 months preceding inclusion * willing to participate after informed consent * positive advice on oat after dise exclusion criteria: * insufficient teeth to support the device * periodontal problems including tooth mobility * active temporomandibular joint dysfunction * limited maximum protrusive capacity (\< 6 mm)
study of serum markers for cardiovascular risk in obese youth and impact of lifestyle and medication intervention

Conditions: Obesity

Summary: in protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hscrp concentration greater than or equal to 2 standard deviations (sd) above the mean established in our lab for lean controls in protocol #1). they will be randomly assigned to either lifestyle intervention (diet/exercise) or diet/exercise plus metformin for 6 months. after the 6 month evaluation the subjects will cross over the treatment arms, i.e., those that were doing diet/exercise intervention only will add metformin, those that were doing the diet/exercise plus metformin will discontinue the metformin and continue with diet/exercise changes only. intrahepatic fat contents will be measured as well. the investigators hypothesize that obese children in these age groups will have increased cardiovascular risk related to their obese state before reaching the currently defined criteria of metabolic syndrome. the investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions.


Eligibility criteria:
inclusion criteria: * ages 7-18 years. * greater than the 95th percentile body mass index for their age and gender. * children are in tanner stage i or iv or v. * normal blood pressure. * normal fasting glucose. * normal lipids. * menstruating girls must have completed their most recent period at least 2 weeks prior to blood draw. * no recent illness, no chronic illnesses, no routine medications, no smoking or alcohol intake. * must pass the screening test done in protocol #1. * must have higher values than normal for certain blood tests related to heart disease that were measured in protocol #1. exclusion criteria: * chronic active illnesses. * recent illnesses. * use of routine medications, vitamins, herbal remedies, oral contraceptive pills, or other over the counter medications within 4 weeks of blood draw. * history of recent or chronic smoking. * currently pregnant. * impaired fasting glucose. * dyslipidemia. * actively in puberty. * weight greater than 300 pounds. * metal in the abdomen. * history of being overweight greater than 5 years.
preventive intervention to promote healthy ageing

Conditions: Preventive Intervention

Summary: the aim of the project is the support of healthy ageing of older adults in acommunity. efficient educational and psychosocial intervention will besuggested and verified to prevent anxiety, depression, and cognitivedisorders of selected older adults, to im-prove their self-esteem,meaningfulness of life, sense of coherence, quality of life, and attitudes toold age. correlations among anxiety, depression, cognitive functions, andcertain psychosocial aspects will be analyzed.

the main objective of the project is to determine the efficiency ofeducational pro-grams and psychosocial interventions to maintain mentalhealth, to prevent and timely diagnose any depression, anxieties, andcognitive disorders in older adults living in a community. furthermore, theaim is to ascertain the incidence of depression, anxiety, and cognitivedisorders in these older adults and its correlation to the assessment of lifemeaningfulness, self-respect, attitudes to old age and ageing, and the levelof social support. an intervention study will be carried out. a preventionprogram will be for-mulated based on the individual needs of older adults asidentified in the focus groups. selected interventions will be performed in apresent form (face to face) as well as distance form (e-health) and will runat least for 6 months. the assessment of anxiety, depression, cognitivefunctions, and other psychosocial aspects will be done before theinterventions start, when they finish, and 3 months after that. based on-quantitative analysis, there will be evaluated the efficiency of the providedinterven-tion with respect to depression, anxiety, cognitive function, andpsychosocial aspects (attitudes to old age, self-esteem, the sense ofcoherence, quality of life, level of social support). older adults in thecentrum for prevention and support healthy ageing in the community will beincluded in the research sample. based on the findings, recommen-dations will be formulated regarding the selected interventions used in communi-tycare.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years * living at home in moravian-silesian region * consent with partici-pation in the study * no dementia diagnosis. exclusion criteria: * dementia diagnosis

Keywords: mental health quality of life anxiety depression population ageing
the effect of breast milk sniffing and tasting on early feeding tips

Conditions: Breastfeeding; Odors, Body; Newborn; Vitality

Summary: the study aimed to investigate the effects of breast milk sniffing and breast milk tasting and sniffing on sucking success and early feeding cues in term newborns who were started to breastfeed for the first time.

in the literature, there are many studies examining the odor effect or odor and taste effect during gavage feeding of premature and low birth weight infants hospitalized in the neonatal intensive care unit (nicu). however, no study was found to examine the effect of smell and taste application on breastfeeding success and early feeding cues during initiation of breastfeeding for the first time in healthy term newborns. it is clear that sick newborns need much more support and intervention in the transition to oral feeding. however, the low rates of breastfeeding in our country indicate that the use of effective and facilitating methods to initiate and maintain breastfeeding is also necessary for term and healthy infants. therefore, this study may guide healthcare professionals on the effectiveness of odor and taste stimulation for early breastfeeding and provide ideas for designing new research and projects.

Eligibility criteria:
inclusion criteria: * for the mother * having a term and healthy baby, * no communication and language problems, * no maternal illness preventing breastfeeding (active chemotherapy, hiv positive, neurological or psychological problems, etc.), * willingness to breastfeed, for the baby; * not having a disease condition that prevents breastfeeding (cleft palate, cleft lip, galactotemia, choanal atresia, etc.), * being at normal birth weight (2500gr-4000gr), * apgar score of 7 and above. exclusion criteria: * under 18 and over 40 years of age, * development of postpartum complications (in mother or baby), * multiple pregnancy.
prospective clinical analysis of ultrasound-guided biceps corticosteroid injections

Conditions: Biceps Tendonitis; Injection

Summary: using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables.

patients are diagnosed with biceps tendinitis in the outpatient clinic. after diagnosis, all the patients that meet inclusion/exclusion criteria will be offered to enroll in the study. study will be described to the patient with regard to protocol and consent. all questions regarding the study will be answered, and it will be explicitly described that the study involvement will not change clinical care. it will be explained that investigators expect a follow up appointment at minimum at three weeks and three months. there may be further follow up requested up to 1 year from enrollment. after collection of informed consent, the patient will be randomized to either ultrasound-guided or landmark-guided injection. the patient will complete clinical scores at the initial visit prior to the injection. after injection, the patient will have follow up scheduled for three weeks and three months. to ensure patient blinding, an ultrasound will be placed on the patient for both groups, but only active imaging with be performed for the ultrasound-guided patient group. for clinician blinding, a different clinician than the injecting clinician will perform the follow up examinations. the patient is instructed to not seek additional injections or physical therapy during the study.

Eligibility criteria:
inclusion criteria: * pain at intertubercular groove * anterior humeral pain * positive speed's test * bicep's tendinitis is primary diagnosis for patient * patient agrees to follow up and consent exclusion criteria: * prior biceps surgery or injections * prior slap or labral repair * concomitant shoulder arthroplasty
biomarkers of recurrence and progression in non-muscle invasive bladder cancer

Conditions: Non-muscle Invasive Bladder Cancer; Cystoscopy; Recurrence; Progression; Bladder Cancer; Biomarkers

Summary: bladder cancer (bc) is one of the most common type of cancer globally. due to its high incidence rate, high risk of recurrence and progression, and frequent cystoscopy surveillance, bc contributes to major healthcare costs across the world. the goal of this prospective study was to evaluate the prognostic value of novel non-muscle invasive bladder cancer (nmibc) biomarkers for predicting disease recurrence or progression after radical transurethral resection of bladder tumour (turbt). the data obtained from this study may help physicians identify patients who are at greater risk of nmibc recurrence or progression and require close supervision.

the aim of our prospective study was to determine the prognostic impact of the inflammatory response and indicators of nutritional status on recurrence and progression of non-muscle invasive bladder cancer (nmibc) in patients undergoing transurethral resection of bladder tumour (turbt). we evaluated six biomarkers, 3 in blood serum: soluble urokinase plasminogen activator receptor (supar), plasminogen activator inhibitor-1 (pai-1), interleukin 8 (il-8) and 3 in urine: apolipoprotein e (apoe), vascular endothelial growth factor (vegf), interleukin 8 (il-8). furthermore, following indicators of nutritional status were investigated: glasgow prognostic score (gps) and modified glasgow prognostic score (mgps). the primary endpoint of this study was the recurrence or progression of nmibc based on the histopathological or cystoscopic result. the study outcome was evaluated during the first surveillance cystoscopy, which was performed in time intervals indicated by european association of urology. based on literature data and statistical assumptions we aimed to recruit 240 patients with nmibc.

Eligibility criteria:
inclusion criteria: * signed informed consent form * presence or suspicion of tumour in urinary bladder * qualification for the first transurethral resection of bladder tumour exclusion criteria: 1. age \< 18 years 2. active urinary tract infection 3. active autoimmune disease 4. end-stage renal failure and renal replacement therapy 5. active hepatitis a, b or c 6. active hiv infection 7. pregnancy 8. factors disqualifying the patient from adjuvant treatment (intravesical immunotherapy or intravesical chemotherapy) 9. bladder tumour stage t2 or more, or urothelial tumour in a location other than the urinary bladder 10. other cancer or systemic anticancer treatment carried out up to 5 years ago 11. factors disqualifying the patient from surgical treatment, e.g. coagulopathies 12. lack of patient consent to collection of blood and urine samples and to follow-up visits

Keywords: non-muscle invasive bladder cancer cystoscopy recurrence progression bladder cancer biomarkers
comparison of scalp microbiota of the psoriasis and seborrheic dermatitis patients

Conditions: Psoriasis Vulgaris; Seborrheic Dermatitis; Microbial Colonization

Summary: a sterile swap specimen taken from the scalp of the patients with psoriasis vulgaris or seborrheic dermatitis and the volunteer control group will be examined in our study. the examples of the microbiota of the patients will be taken both the lesional scalp and the lesion-free part of the scalp. then, the microbiota differences between the lesioned scalp and the lesion-free scalp of both groups, and the microbiome differences between the two groups and the control group will be evaluated.


Eligibility criteria:
inclusion criteria: 1. patients with scalp psoriasis 2. patients with seborrheic dermatitis 3. agree to participate in research 4 - do not use any drugs for their disease topically or systemically for two months exclusion criteria: 1. patients who do not want to participate in the study 2. patients with psoriasis vulgaris or seborrheic dermatitis that does not effect scalp. 3. those with chronic diseases that may affect skin microbiome 4. patients using antibiotics, antifungal or antiviral therapy for any reason for the last one month. 5. patients who are using topical or systemic drugs for their illness

Keywords: psoriasis vulgaris seborrheic dermatitis scalp microbiome
peroral endoscopic myotomy for the treatment of achalasia

Conditions: Achalasia

Summary: there will be a retrospective chart review for patients who underwent endoscopic procedures and poem from 06/2016 - 01/2019 \& a prospective chart review will be performed for patients who will undergo endoscopic procedures and poem from 02/2019 - 06/2021

subjects will undergo no additional tests and procedures as part of this study. all data will be collected from patient's electronic health records (ehr) of the hospital in addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and poem from 02/2019 - 06/2021. all the subjects enrolled in prospective chart review will be first consented for their study participation. subjects will undergo a clinically indicated endoscopic procedure and poem and subsequent follow-up clinical visits as part of their standard medical care. all procedures, barring research activities such as consenting and data collection from electronic health records, will be either clinically indicated and/or standard of care. * each patient in the study will be assigned a case id number to de-identify their personal health information during data collection * the case id number connecting the patient to the personal health information will be in an encrypted electronic file on a computer that can only be accessed by study members at mdmc. * a procedure report and outpatient clinical records for each subject's poem procedure will be used to record each patient's data for the registry * that data will only be shared by members of the study (pis, research coordinator) who require it for conducting of data collection/interpretation "disclaimer: any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)."

Eligibility criteria:
inclusion criteria: * any discharged patient who has undergone clinically indicated and/or standard of care poem for the treatment of achalasia from 6/2016 to 6/2021. * above or equal to 18 years of age exclusion criteria: * any patient who has not undergone poem for the treatment of achalasia. * below 18 years of age
non-invasive quantification of liver iron with mri

Conditions: Iron Overload; Hemosiderosis

Summary: the purpose of this study is to validate magnetic resonance imaging as a biomarker of hepatic iron concentration (hic). excessive accumulation of iron in the body is highly toxic, specifically in the liver. accurate, non-invasive assessment of hic is needed for diagnosis, quantitative staging and treatment monitoring or hepatic iron overload.

excessive accumulation of iron in the body can result from abnormal intestinal absorption in hereditary hemochromatosis or repeated intravenous blood transfusions (ie: transfusional hemosiderosis). excess body iron is highly toxic, and requires treatment aimed at reducing body iron stores. measurement of body iron stores is critical for detection of iron overload, staging its severity and monitoring of iron-reducing therapies that are often extremely expensive (\>$40,000/year) and carry their own toxicities. mri has been shown to be very sensitive to the presence of iron. the investigators have developed an mri-based method for rapid iron quantification (for instance, whole liver in a single breath-hold). the purpose of this work is to validate this new method using the fda-approved ferriscan technique (resonance health, claremont, australia) as a reference standard.

Eligibility criteria:
inclusion criteria: * controls: 18 years or older with no known history of iron overload or liver disease. * patients: 10 years or older with known or suspected iron overload exclusion criteria: * patients with contraindications to mri (eg. pacemaker, contraindicated metallic implants, claustrophobia, etc) and pregnant females (as determined by self-report during mri safety screening) will be excluded. * for control subjects, those with known liver disease will be excluded.
success of transitioning uncontrolled glaucoma patients from prior mono or adjunctive therapy to duotrav

Conditions: Glaucoma

Summary: the purpose of this study is to assess the safety and efficacy of transitioning uncontrolled glaucoma patients to duotrav from other mono or adjunctive therapies.


Eligibility criteria:
inclusion criteria: * adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma. * other protocol-defined inclusion criteria may apply. exclusion criteria: * age related. * other protocol-defined exclusion criteria may apply.

Keywords: glaucoma