Kornimate/medical-research-clean huggingface dataset:
clinical calibration & validation of a next-generation blood pressure monitor for patient management

Conditions: Hypertension

Summary: the objective of the cloud dx pulsewave health monitor study is to prospectively calibrate and validate a novel, non-invasive wrist cuff blood pressure device against the gold standard for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented patient participants who are scheduled for an elective cardiac catheterization procedure for clinically valid reasons.

the cloud dx pulsewave health monitor is a non-invasive wrist cuff blood pressure device that is licensed by health canada with food and drug administration approval. systolic and diastolic pressures are measured via the arterial pulse waveform of the left radial artery. initially, the blood pressure algorithm was created and calibrated using the auscultatory method. the purpose of this study is to calibrate the device to the clinical gold standard of peripheral and central intra-arterial pressures. the device acquires a pulse signal in real-time, stores signal and measurement data, and displays stored signal and measurement data for interpretation via internet servers where it is accessible by end-users (physicians and/or patients). the system provides secure accounts for both in-patient and out-patient monitoring. cloud dx's pulsewave health monitor servers are housed in a secure data center. privacy measures are to ssae16 soc-1 type-ii compliance: 1) restricted secure access, 2) dedicated firewall, 3) https channel communication via website, 4) self-encrypting hard-drives rendered useless if removed from the server.

Eligibility criteria:
inclusion criteria: * ≥ 19 years of age * patients recommended by their cardiologist for a first-time, elective cardiac catheterization procedure * wrist circumference between 13.5cm - 23cm (5.3 - 9.1in.) * bilateral arm blood pressure equality (systolic within ±10mmhg; diastolic within ±5mmhg) on 2 separate readings (nurse associate \& tra) * willing to volunteer to participate and to sign the study specific informed consent form exclusion criteria: * no history of peripheral vascular disease, no previous percutaneous coronary intervention, nor previous coronary artery bypass graft * no arrhythmia * no abdominal aortic aneurysm * no hand/body tremor

Keywords: hypertension telemonitoring vital signs
knowledge attitudes beliefs and practices relative to hiv among sex workers in french guiana

Conditions: HIV

Summary: the aim was to determine the knowledge attitudes, beliefs, and practices regarding hiv in a population of sex workers in french guiana and in the brazilian border town of oiapoque. a standardized questionnaire was administered face to face to sex workers. analysis of the questionnaires led to descriptive statistics. multiple logistic regression models were computed to determine the predictors of condom use.


Eligibility criteria:
inclusion criteria: * sex worker exclusion criteria: * not wishing to participate
oropharyngeal aspiration to reduce ventilator-related pneumonia

Conditions: Ventilator-associated Bacterial Pneumonia

Summary: ventilator-associated pneumonia (vap) is one of the healthcare-related infections that is common in critically ill patients, prolongs hospital stay, significantly increases mortality and additional health care costs. microaspiration of oropharyngeal secretions the primary pathway in the formation of vap has led researchers to focus on the detection of applications to prevent microbial colonization. continuous or intermittent oropharyngeal aspiration, open system aspiration versus closed system aspiration, extensive oral care, oropharyngeal aspiration prior to patient positioning are some of these applications. when the patient is turned to position, the outbreak accumulated in the oral cavity is more likely to move to the lower respiratory tract. in this study, it is assumed that aspiration of oropharyngeal secretions prior to each position change will reduce the accumulation of oral secretion in the endotracheal tube cuff and reduce aspiration of contaminated secretion and reduce the risk of developing vip. this randomized controlled experimental study was planned to confirm the validity of this assumption. this study was a randomized controlled experimental study designed to investigate the effect of oropharyngeal aspiration on decreasing the incidence of ventilator-associated pneumonia in patients receiving mechanical ventilation. the research was conducted between july 2015 and april 2019 in anesthesiology and reanimation intensive care unit. the study was carried out with 20 patients who underwent oropharyngeal aspiration as needed and 20 patients with oropharyngeal aspiration prior to each change of position.


Eligibility criteria:
inclusion criteria: * over 18 years of age, * supported mechanical ventilation by endotracheal tube, * ≥ 24 hours remaining connected to mechanical ventilator, * position can be changed every 2 hours during the day and 4 hours at night, * patients whose relatives were approved to participate in the study. exclusion criteria: * pneumonia develops prior to mechanical ventilation support or within the first 48 hours following mechanical ventilation support, * positive sputum culture was taken before mechanical ventilation support or within the first 48 hours following mechanical ventilation support, * patients with diabetes mellitus, * patients with contraindications for routine change of position
clinical trial to assess the preventive effects of cetylpyridinium chloride on sarcopenia

Conditions: Sarcopenia

Summary: this study is to assess the impact on the prevention of sarcopenia after taking cetylpyridinium chloride targeting the patients of pre-sarcopenia or sarcopenia over the age of 60

75 people that meet the inclusion criteria on screening test are assigned to one of three groups by randomization. they take the medication for four weeks under doubleblind. two study groups take cetylpyridinium chloride of 1.5mg, 4.5mg daily for four weeks. control group takes the placebo for the same period. the main outcome variables are measured and compared respectively in baseline, immediately after dosing end and two weeks, four weeks after the end of administration. finally cetylpyridinium chloride is verified whether it has a preventive effect on sarcopenia and set an appropriate dose.

Eligibility criteria:
inclusion criteria: * pre-sarcopenia a. reduced skeletal muscle mass (appendicular skeletal muscle mass/height2) m \< 7.0kg/m2, f \< 5.7kg/m2 exclusion criteria: * history of stroke or spinal cord injury * artificial joint * acute disease or unstable chronic disease * phenylketonuria * history of myocardiac infarction * allergic contact dermatitis * history of drug/alcohol addiction, habitual smoker

Keywords: sarcopenia cetylpyridinium chloride
study of oral fluid testing approach

Conditions: Cannabis Use; Cannabis Intoxication; Cannabis Use Disorder

Summary: the purpose of this study is to identify and evaluate oral fluid testing as a biologic measure of cannabis use days that can be assessed remotely. the researchers will conduct this fully virtual study among a community sample of 200 individuals aged 18-30 years who have used cannabis at least 1 time per week on average in the past 30 days. participants will complete oral fluid (saliva) tests, urine tests, and timeline follow-back interviews (self-report) that indicate their recent cannabis use (delta-9-thc). participants will present for 3 virtual study visits and be asked to complete activities in between: study visit 1 (day 0; informed consent, baseline survey, tlfb interview), study visit 2 (\~day 3; tlfb interview, urine testing), 6 days of at-home videorecorded oral fluid testing, study visit 3 (\~day 12; tlfb interview, urine test, oral fluid test, survey, interview).


Eligibility criteria:
inclusion criteria: * age 18 to 30 years * cannabis use on \>=1x/week in the past 30 days * ownership of a portable device that is capable of videoconference and videorecording (i.e., smartphone, tablet computer, or laptop computer) * ability to read and speak english * availability for duration of the study (2-3 weeks). * to proceed to oral fluid testing, positive result for urinary tch-cooh exclusion criteria: • inability/unwillingness to provide contact information

Keywords: cannabis use young adult oral fluid testing
changes of plantar pressure after knee reconstructive surgery

Conditions: Knee Pain Treated With Knee Arthroplasty

Summary: knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of alignment of the lower limb axis. this affects also biomechanics of the hindfoot. there is a lack of understanding what changes of alignment of the lower limb causes to the ankle. the investigators want to evaluate the effects of knee surgeries onto the plantar foot pressure investigated by means of static and dynamic pedography.


Eligibility criteria:
inclusion criteria: * patients planned for knee surgery willing to participate at this study exclusion criteria: * no informed consent
a study of aticaprant plus an antidepressant to prevent return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure

Conditions: Depressive Disorder, Major; Anhedonia

Summary: the purpose of this study is to assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor \[ssri\] or serotonin-norepinephrine reuptake inhibitor \[snri\]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.


Eligibility criteria:
inclusion criteria: * be medically stable based on physical examination (including a brief neurologic examination), medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ecg) performed at screening and ol baseline * be medically stable based on clinical laboratory tests performed at screening * meet dsm-5 diagnostic criteria for recurrent or single episode mdd, without psychotic features upon clinical assessment and confirmed by the structured clinical interview for diagnostic and statistical manual of mental disorders-5th edition (dsm-5) axis i disorders-clinical trials version (scid-ct) * have symptoms of anhedonia based on clinical assessment and confirmed by presence of anhedonia (positive response to major depressive episode (mde) module symptom item 2) on the scid-ct at screening exclusion criteria: * has had no response to 2 or more consecutive antidepressant treatments administered at adequate dose and duration in the current episode of depression including the current selective ssri/snri assessed using the massachusetts general hospital antidepressant treatment response questionnaire (mgh atrq) * has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy * has a history of moderate-to-severe substance use disorder including alcohol use disorder according to dsm-5 criteria within 6 months before screening * has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase * has cognitive impairment per investigator judgment that would render the informed consent invalid or limit the ability of the participant to comply with the study requirements
biomarkers of response in blood and tumor tissue samples from patients with unresectable stage iv squamous cell cancer of the head and neck previously treated with cetuximab, cisplatin, and radiation therapy

Conditions: Head and Neck Cancer

Summary: rationale: studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors understand how patients respond to treatment. purpose: this research study is studying biomarkers of response in blood and tumor tissue samples from patients with unresectable stage iv squamous cell carcinoma of the head and neck previously treated with cetuximab, cisplatin, and radiation therapy.

objectives: primary * to expand upon the list of molecular correlates indicated in clinical trial ecog-e3303, including egfr expression, egfr phosphorylation, map kinase, akt, and stat3. * to correlate the status or expression level of each biomarker with clinical outcome (response, progression-free survival, overall survival). outline: archived tumor and blood specimens are analyzed for human papilloma virus and p16 status; egfr gene amplification; levels of ercc1, xpf, and c-met proteins; expression and activation of several signaling pathways including pi3 kinase gene and mtor; levels of erbb2, erbb3, p70s6 kinase, s6 , and akt; expression of amphiregulin (ar), tgf-alpha (tgf-α), heparin-binding egf-like growth factor (hb-egf), egf, epiregulin and c-met ligand, and hepatocyte growth factor by fluorescence in situ hybridization (fish), automated in situ quantitative measurements of protein analysis (aqua), ihc, pcr, and elisa.

Eligibility criteria:
disease characteristics: * diagnosis of squamous cell carcinoma of the head and neck * stage iv disease * unresectable disease * treated with cetuximab, cisplatin, and radiotherapy on clinical trial ecog-e3303 * archived blood and tumor tissue samples available patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage iv squamous cell carcinoma of the lip and oral cavity stage iv verrucous carcinoma of the oral cavity stage iv squamous cell carcinoma of the nasopharynx stage iv squamous cell carcinoma of the oropharynx stage iv squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the larynx stage iv verrucous carcinoma of the larynx
feasibility study of aerosolized surfaxin in the prevention of respiratory distress syndrome (rds) in premature infants

Conditions: Respiratory Distress Syndrome

Summary: to evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (ncpap) for the prevention of respiratory distress syndrome (rds) in premature infants.

use of a device in the early treatment of rds that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. this approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.

Eligibility criteria:
inclusion criteria: * gestational age 28-32 completed weeks, inclusive * placement of arterial line * successful initiation of ncpap * informed consent exclusion criteria: * heart rate that cannot be stabilized \>100 bpm within 5 minutes of birth * five (5) minute apgar score ≤ 3 * major congenital malformation(s) diagnosed antenatally or noted immediately after birth * other disease(s) or conditions potentially interfering with cardiopulmonary function * mother with prolonged rupture of membranes \> 2 weeks * known or suspected chromosomal abnormality * need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room * need for mechanical ventilation within 30 minutes of birth

Keywords: lucinactant nasal continuous positive airway pressure (ncpap) respiratory distress syndrome (rds) pediatric premature
tissue characterization and primary percutaneous coronary intervention guidance using intravascular ultrasound

Conditions: ST Elevation Myocardial Infarction; Acute Myocardial Infarction; Coronary Artery Disease; Percutaneous Coronary Intervention; Intravascular Ultrasound; Thrombus

Summary: this prospective, single arm, observational cohort study is designed to assess the safety and efficacy of (high-definition) intravascular ultrasound (hd-ivus) as guidance for primary percutaneous coronary intervention (pci) and to assess culprit lesion plaque characteristics and thrombus morphology in patients with st-elevation myocardial infarction (stemi). objectives: * to assess clinical outcomes after ivus-guided primary pci in stemi patients. * to assess ivus-guided optimization in stemi patients. * to assess culprit lesion plaque characteristics in stemi patients with hd-ivus. * to assess and quantify thrombus in stemi patients with hd-ivus. * to explore hd-ivus derived predictors for clinically relevant aspiration thrombectomy.

the spectrum study is an investigator-initiated, single-center, prospective, single arm, observational cohort study investigating the safety and efficacy of (hd)-ivus as guidance for primary pci in 200 patients with stemi. this study enables the assessment of culprit lesion plaque characteristics and thrombus morphology with a 40-60 mhz hd-ivus catheter. all study patients will have a protocolized pre-intervention ivus pullback directly after recanalization (so before any lesion preparation, i.e. balloon dilatation, aspiration thrombectomy or stent placement) and a post-intervention ivus pullback. subsequently, if ivus-guided optimization is performed, a final pullback is highly recommended and considered as the post-optimization ivus pullback. the primary study outcomes are target vessel failure at 12 months and incidence of ivus-guided optimization. more information on outcome measures is provided in the section below.

Eligibility criteria:
inclusion criteria: * native coronary artery culprit lesion, angiographically * culprit vessel reference diameter ≥ 2.25 mm, angiographically exclusion criteria: * cardiogenic shock * presentation \> 12 hours after symptom onset

Keywords: invasive coronary imaging
antenatal depression help-seeking trial in eswatini

Conditions: Help-Seeking Behavior; Help-seeking Intention; Antenatal Depression

Summary: the goal of this trial to test if a web-based psychoeducation will work in improving depression help-seeking intention and behavior among antenatal women with probable depression in eswatini. the main question it aims to answer is: • does the web-based psychoeducation improve depression help-seeking intention and help-seeking behavior in antenatal women with probable depressive symptoms? researchers will compare this web-based psychoeducation to a waitlist control, to see if the program works in improving depression help-seeking intention and behavior during pregnancy. * the psychoeducation program will have a total of 4 sessions, which will be given to participants over a two-week period. two sessions will be delivered each week. * participants will be asked questions before the intervention starts, immediately the intervention ends as well as after a month of completing the intervention.


Eligibility criteria:
inclusion criteria: * less than 30 weeks of gestation, * aged 18 or above * with probable depression (edinburg postnatal depression scale; epds \> 10) * has access to a smart phone * fluent in spoken and written siswati or english (with at least secondary school education) * planning to remain in the country for the next 2 months * willing to share her dominant phone number with the study team * willing to participate in the intervention study exclusion criteria: * antidepressants or other depression treatments * currently enrolled in another trial

Keywords: antenatal depression web-based interventions psychoeducation rct eswatini help-seeking
a trial investigating the pharmacokinetic and pharmacodynamic properties of insulin icodec in subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment. participants will get insulin degludec as well as insulin icodec - insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors. participants will administer subcutaneous injections of insulin degludec once daily for at least one week (7 injections) but this period may be extended up to 8 weeks. thereafter, once weekly subcutaneous injections of insulin icodec will follow, resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec. the study will last for about 17-32 weeks participants will have at least 5 in-house visits (where participants will stay at the clinic) and 17 outpatient visits with the study doctor. women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female * aged 18-75 years (both inclusive) at the time of signing informed consent * body mass index between 18.0 and 38.0 kg/m\^2 (both inclusive) * hba1c (glycated haemoglobin) below or equal to 9 percentage (75 mmol/mol) at screening * current daily basal insulin treatment greater than or equal to 0.2 (i)u/kg/day with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to the day of screening: 1) any metformin formulation 2) other oral antidiabetic drugs: dpp-4 nhibitors / sglt2 inhibitors / oral combination products (for the allowed individual oral antidiabetic drugs) * oral or injectable glp-1 receptor agonists exclusion criteria: * known or suspected hypersensitivity to trial product(s) or related products * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method
novel modified technique for transcatheter closure of secundum atrial septal defect: a single center experience

Conditions: Atrial Septal Defect (ASD)

Summary: transcatheter closure of secundum atrial septal defects is widely approved worldwide, yet it still has multiple risks like perforation and radiation exposure. in this study, we proposed a modified rapid method for closure of secundum atrial septal defects, to avoid material manipulation inside your heart and decrease complication rate.

delivery sheath can be advanced over multipurpose catheter instead of stiff wire

Eligibility criteria:
inclusion criteria: * any patient with ostium secundum asd \& rv volume overload exclusion criteria: * any other type of atrial septal defects any other associated congenital anomaly

Keywords: atrial septal defects transcatheter closure modified technique