Kornimate/medical-research-clean huggingface dataset:
the effects of the maternal voice combined with lullaby to reduce the heel puncture pain in preterm infant

Conditions: Pain

Summary: in taiwan, 183,254 newborns were born in 2018, with preterm births accounting for about 8-10%. the preterm infant required frequent medical treatment from birth to hospital discharge, which is accompanied by a painful process that can cause unstable vital signs in the short term and may affect their biological and psychological development in the long term. music therapy is a non-invasive and easily accessible intervention, can be used to reduce the discomfort of painful stimulation during hospitalization of preterm infants. music therapies in this text are the mother's voice and lullabies.

this study was a quantitative study of a randomized controlled trial, designed by experimental research method, and followed the principle of allocation concealment to conduct a randomized assignment trial. using g\*power 3.1 to estimate the number of samples, and the statistical method chosen was repeated measures anova, the sample size is 120. the subjects were divided into four groups, all four groups were administered general routine care, three experimental groups, and one control group, and the experimental group was a repetitive segment of audio recording edited to 13 minutes. there were three interventions: group a maternal voice reading children's books, group b lullaby, group c maternal voice reading children's books combined with lullaby, and the control group was the routine care group without any audio intervention. physiological indicators, including heart rate, respiratory rate, oxygen saturation, and pain response assessed using the neonatal infant pain scale (nips), were recorded 3 minutes before, during, 1st, 3rd, and 10 minutes after heel lance puncture.

Eligibility criteria:
inclusion criteria: 1. babies born alive before 37 weeks of pregnancy. 2. infants who were required to receive heel lance procedure every 8 hours after physicians' diagnoses. 3. those who can record the mother's voice and whose mother can read chinese. exclusion criteria: 1. abnormal ear appearance, chromosomal abnormalities, congenital or acquired infections. 2. postnatal patients whose mothers are not in the postnatal ward, e.g., those who need to be admitted to the intensive care unit due to their medical condition. 3. patients used high-frequency oscillatory ventilators, because the high-frequency oscillatory ventilator gives 600 oscillatory breaths per minute and it is not possible to evaluate whether the study subjects can effectively listen to the interventions given, so they were excluded. 4. mothers who were unable to complete the recording because of emotional ups and downs during the recording process. 5. mothers who smoked, drank alcohol or used illegal drugs during pregnancy. 6. the patients was diagnosed with asphyxia of the newborn at birth 7. painkillers used within 2 days of birth.

Keywords: premature maternal voice lullaby heel punture neonatal pain
effect of omega3 on congestive heart failure

Conditions: Heart Failure Congestive

Summary: in this double blinded study patients with resynchronization pacemaker- aicd were assigned to omega3 and placebo randomly, results indicated that omega3 had no more effect than placebo in mortality, bnp level and 6 minutes walk test.

introduction: widely used as lipid lowering agents, omega 3 fatty acids have been demonstrated to possess the potential to reduce the risk of cardiovascular events in patients suffering from chronic heart conditions. in this double -blinded randomized placebo-controlled clinical trial, we aim to investigate the possible beneficial effects of omega-3 supplements on echocardiographic parameters and brain natriuretic peptide (bnp) plasma levels in patients suffering from congestive heart failure (chf). methods and materials: 100 patients with class ii and iii chf, who had tri-chamber pacemaker and automated defibrillator( crt-aicd) were initially recruited among which 70 subjects consented to participate. subjects were randomly assigned and matched to two treatment groups. 42 patients were allocated to a two gram/day dosing of omega-3 capsule while 28 subjects were allocated to the placebo group. demographic features and bnp plasma levels, 6-minute walk test and echocardiographic parameters of patients were recorded at baseline and at 6 months after implementation of treatment protocols. data were further gathered and analyzed to evaluate the beneficial effects of omega-3 supplements compared to placebo. conclusion: beneficial effects of omega-3 supplementation on chf patients were not as dramatic as initially presumed

Eligibility criteria:
inclusion criteria: * ef\< 40% * sinus rhythm * accept randomization * having tri-chamber pacemaker exclusion criteria: * survival less than 6 months * class iv heart failure * using drugs other than study protocol

Keywords: omega 3 crt_aicd congestive heart failure chf
residual neuromuscular blockade in cardiac surgery patients

Conditions: Residual Neuromuscular Blockade

Summary: the purpose of this project is to determine if reversal of neuromuscular blockade in cardiac surgery patients expedites time to extubation in fast track patients.

neuromuscular blocking agents are used as part of most general anesthetics to help facilitate tracheal intubation and optimal surgical conditions (barish et al). these medications cause universal paralysis of patients while unconscious. after most surgeries where extubation is planned, the standard of care is to "reverse" any residual neuromuscular blockade with either anticholinesterase treatment (specifically neostigmine) or sugammadex. despite adequate reversal, residual neuromuscular blockade is a common problem seen in the post-anesthetic care unit (pacu). it leads to issues of airway obstruction, hypoxemia, respiratory complications including atelectasis and pneumonia and muscle weakness (brull et al). the investigators posit that these complications are likely amplified in patients who require post-operative intensive care unit admission. in particular, the investigators hypothesize that cardiac surgery patients are at risk. elective cardiac surgery patients are routinely admitted to the cvicu still intubated and ventilator-dependent immediately following surgery. the goal of uncomplicated cardiac surgery patients (fast track cardiac surgery patients) is to extubate them within 6 hours of icu arrival. however, standard of care throughout the us does not include reversal of their neuromuscular blockade. by the time these patients meet extubation criteria, most providers believe that the neuromuscular blockade should have worn off and therefore do not administer reversal (murphy et al). the investigators hypothesize that residual neuromuscular blockade delays time to extubation and increases respiratory complications in fast track cardiac surgery patients. by administering reversal of neuromuscular blockade in patients with a train of four ratio of \<0.9 we anticipate that there will be an increase from 60 to 85% of patients being successfully extubated within 6 hours of arrival to the icu and a decrease in composite respiratory complications.

Eligibility criteria:
inclusion criteria: * all outpatients \>18 years of age scheduled for elective coronary artery bypass graft surgery (cabg), aortic valve replacement (avr), or combination cabg/avr exclusion criteria: * chronic kidney disease stage iv or v * liver disease, defined as ast, alt or alp \> 1.5x upper limit of normal inpatient status * allergy to rocuronium

Keywords: residual neuromuscular blockade reversal cardiac surgery
study to evaluate isv-305 compared to vehicle for treatment of inflammation and pain associated with cataract surgery

Conditions: Inflammation and Pain Associated With Cataract Surgery

Summary: the purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of isv-305 (dexamethasone in durasite® 2) compared with vehicle in the treatment of inflammation and pain associated with cataract surgery.

the purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of isv-305 (0.1% dexamethasone in durasite® 2) compared with vehicle when dosed twice daily for 1 day prior to surgery, the day of surgery and 14 days post cataract surgery.

Eligibility criteria:
inclusion criteria: * are at least 17 years of age * are scheduled for uncomplicated unilateral cataract surgery * signature of the subject or parent(s) or legally authorized representative on the informed consent form, and when appropriate the minor's assent in accordance with local regulations * are willing and able to follow all instructions and attend all study visits * are willing to avoid disallowed medication for the duration of the study * if female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study * male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility) * additional inclusion criteria also apply exclusion criteria: * have known sensitivity or poor tolerance to any component of the study drugs * have any sign of iritis or scleritis in the study eye * have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye * have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease) * have known blood dyscrasia or bone marrow suppression * have any active corneal pathology in the study eye * have had radial keratotomy, corneal transplant, or lasik in the study eye within the last 2 years * be currently pregnant, nursing, or planning a pregnancy; or have a positive urine pregnancy test * have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device * have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation * use of any medication the investigator feels may interfere with the study parameters * additional exclusion criteria also apply
impact of exercise training on frailty in cvd patients.

Conditions: Frailty; Cardiovascular Diseases

Summary: the aim of this research project is to examine the impact of aerobic exercise on markers of frailty in patients (of 65 years or older) suffering from heart failure (hf) or after coronary artery bypass grafting (cabg) or mini aortic valve replacement procedures (mini-avr).

frailty is defined as a progressive age-related decline in physiological systems that results in decreased reserves of intrinsic capacity, which confers extreme vulnerability to stressors. based on previous research, there are indications that frailty is highly prevalent in hf, cabg and mini-avr patients. as a consequence, these patients (both men and women of 65 years or older) will be included in this research project. the 12-week aerobic exercise program (3 sessions per week) will consist of ergometer, treadmill and arm-ergometer exercises. the intensity will be based on the maximal cardiopulmonary exercise test (cpet) of the patient and will correspond with a heart rate between the first and second ventilatory threshold (with a gradual progression over time). secondary, correlations will be examined between markers of the cpet and frailty markers.

Eligibility criteria:
inclusion criteria: * men and women of at least 65 years of age at the start of the study * to be admitted to jessa hospital hasselt for cardiac rehabilitation after cabg or mini-avr surgery or because of hf * diagnosed as being frail based on the phenotype of fried. exclusion criteria: * a persistently unstable clinical condition (e.g. angina, advanced conduction disturbances, threatening ventricular arrhythmias or acute hf)

Keywords: frailty older adults cardiovascular diseases cardiac rehabilitation
microbiome benchmarking to identify perturbations in multiple sclerosis ii

Conditions: Multiple Sclerosis

Summary: the goal of this longitudinal study is to (1) explore the association between the gut microbiota and inflammatory disease activity in early onset multiple sclerosis, (2) investigate whether/how gut microbial composition vary when patients experience a relapse, and (3) to assess whether the gut microbiota shows increased similarities between affected pairs of first-degree relatives within the same family when compared with discordant pairs of first-degree relatives.

using metagenomics, as well as clinical, immunological, and radiological observations, the investigators will investigate if active relapsing-remitting multiple sclerosis patients have a more pro-inflammatory gut microbiota signature than multiple sclerosis patients with less active disease and matched healthy controls. more specifically, the investigators will investigate whether temporal variability of the gut microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes in the gut microbiota are predictive of future inflammatory disease activity in multiple sclerosis, and whether gut microbiota characteristics are predictive of the disease course after 2 years.

Eligibility criteria:
inclusion criteria patients: * diagnosis of ms (as defined by the 2010 mcdonald criteria). * occurrence of symptoms no longer than 5 years before baseline. * aged 18-65. * willingness to participate in the study and to sign the informed consent. exclusion criteria patients: * treatment with high doses of systemic steroids 2 months before baseline. * use of antibiotics 3 months before baseline. * chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer). * other immune-mediated or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1 and 2, psoriasis). additional inclusion criteria for ms patients undergoing a relapse: • ability to provide a faecal sample within 4 weeks from onset of the first symptoms suggestive of a relapse, before cortisone treatment. a relapse is defined by a new clinical sign or clinical worsening of a previous sign/symptom persisting for \>=24 hours in the absence of fever. additional exclusion criteria for ms patients undergoing a relapse: * treatment with cortisone before collection of baseline faecal sample. * evidence of a relapse less than 2 months before baseline. * switching disease modifying treatment less than 2 months before baseline. inclusion criteria healthy controls: * willingness to participate to the study and to sign the informed consent. * aged \>=18. exclusion criteria healthy controls: * neurodegenerative disorders. * chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer) or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1, psoriasis). * use of antibiotics 3 months before baseline. * treatment with high doses of systemic steroids 2 months before baseline.
xience v® exceed: evaluation of xience v® catheterization lab endpoints and excellence in delivery

Conditions: Atherosclerosis; Coronary Artery Disease

Summary: this trial is to assess physician-determined xience v® eecss acute performance, deliverability and resource utilization in the catheterization lab during commercial use by various physicians with a range of coronary stenting experience

this study will evaluate overall physician-determined xience v® everolimus eluting coronary stent system (xience v®) acute performance, deliverability and resource utilization in the catheterization lab in the "real world" as used by a broad group of physicians at a variety of health care facilities. this study will include all consecutively enrolled patients in the united states of america (usa) who consent to participate and receive xience v® stents.

Eligibility criteria:
general inclusion criteria: * the patient agrees to participate in this study by signing the irb approved informed consent form prior to the index procedure. * alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form prior to the index procedure. general exclusion criteria: * inability to obtain an informed consent is an exclusion criterion.

Keywords: drug eluting stent percutaneous coronary intervention everolimus
perception of facial expressions following correction of wrinkles and folds

Conditions: Wrinkles and Folds in Lower Face

Summary: the purpose of this study is to evaluate the perception of facial expressions following correction of wrinkles and folds in the lower face using emervel classic lidocaine and emervel deep lidocaine.


Eligibility criteria:
inclusion criteria: * signed informed consent * nlfs assessed as moderate of severe using the wsrs * intent to undergo optimal correction of both nlfs * intent to undergo correction of at least one other wrinkle or fold in the lower face exclusion criteria: * subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction * subject who presents with severe midface volume loss * subject who presents with facial hair, e.g. beard, moustache, in the treatment area * woman who is pregnant or breast feeding or plans to become pregnant during the study * treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (inhaled corticoids are allowed) within three (3) months before study treatment * previous surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area * previous tissue augmenting therapy or contouring with permanent filler or fat-injection below the zygomatic arch * previous tissue augmenting therapy, contouring or revitalisation treatment with non-ha filler, e.g. calcium hydroxyapatite (caha), or poly l-lactic acid (plla), below the zygomatic arch within 24 months before treatment * previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler below the zygomatic arch within 12 months before treatment * previous tissue revitalisation treatment with neurotoxin below the zygomatic arch within six (6) months before treatment * previous tissue revitalisation treatment with laser or light, mesotherapy, chemical peeling or dermabrasion below the zygomatic arch within six (6) months before treatment * any medical condition that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
virtual classroom training and sms supported interventions improving foot care and self-efficacy

Conditions: Diabetic Foot Ulcer

Summary: the type of this research is a randomized controlled experimental study. the aim of the research is to determine the effectiveness of virtual classroom training and sms support in improving foot care behaviour and foot care self-efficacy in diabetic patients. the basic questions the research aims to answer are: * is virtual classroom training effective in improving foot care behaviour and foot care self-efficacy in diabetic patients? * are sms-supported interventions effective in improving foot care behaviour and foot care self-efficacy in diabetic patients? within the scope of the research, participants are expected to attend virtual classroom training and read the sms sentences sent. in order to examine the effects of virtual classroom training and sms-supported interventions, researchers created a control group, a virtual classroom, an sms support group, and an sms-supported virtual classroom group.


Eligibility criteria:
inclusion criteria: * reporting that you have internet, computer/smartphone access * becoming literate * ability to use the internet and mobile devices effectively * declaring that you are competent to use technology-based training * being between the ages of 18-55 * diagnosis period of 1 year or more exclusion criteria: * having a psychiatric/neurological disability that may prevent participation in the research * having any diagnosis of learning disability * having an existing foot ulcer * having a history of foot ulcers and amputation in the past * having severe vision problems/retinopathy * having severe hearing impairment

Keywords: diabetic foot virtual systems short message service
the role of epicardial adiposity in heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction (HFPEF)

Summary: in this study the investigators are aiming to recruit 130 patients with heart failure with preserved ejection fraction who are obese and non-obese to undergo ct and mri scans, as well as some other investigations including blood tests, to help investigate if having more fat around the heart leads to worse heart function in this condition. this may lead to the development of new treatments aimed at lowering fat levels around the heart and in the rest of the body, specifically to treat hfpef.

dysregulated adipose tissue, in particular epicardial adipose tissue (eat; fat around the heart) may be central to the pathogenesis of obesity related hfpef. existing studies have been limited by selection bias (only including obese cohorts), limited cardiac structural and functional assessment (primarily using echocardiography) and lack of corroborating biological data to imply causality. pilot data demonstrate important associations between eat with concentric lv remodelling in cohorts at high risk of hfpef. further exploration of the role of eat and other ectopic fat depots in patients with hfpef with and without obesity, will provide novel insights into mechanisms by which adiposity drives development of hfpef. in this single centre, prospective, case-control study the investigators will recruit participants with hfpef with and without obesity (total n=130) and utilise multimodality imaging to comprehensively characterise the role of excess adiposity and ectopic fat, specifically eat, to cardiac dysfunction in hfpef.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * aged ≥18 years old * diagnosed with hfpef and diagnosis confirmed by an experienced cardiologist using the hfa-peff diagnostic algorithm * echocardiogram performed within 12 months * able to understand written english exclusion criteria: * lv ejection fraction \<45% * severe primary valvular heart disease * hfpef due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease * known heritable, idiopathic or drug-induced pulmonary arterial hypertension * absolute contraindications to cardiac ct or mri including estimated glomerular filtration rate (egfr) ≤30ml/min/1.73m2. patients with mri-compatible devices are be excluded. * women who are pregnant

Keywords: heart failure heart failure with preserved ejection fraction epicardial adipose tissue adiposity