Kornimate/medical-research-clean huggingface dataset:
single-versus multiple-dose antimicrobial prophylaxis for peroral endoscopic myotomy in achalasia

Conditions: Achalasia Cardia

Summary: achalasia cardia is a primary oesophageal motility disorder of unknown etiology. recently, peroral endoscopic myotomy (poem) has gained widespread acceptance as an effective treatment modality for achalasia. major adverse events are uncommon with poem. since the operator works close to mediastinum during the poem procedure, there is a potential for infectious complications. therefore, intravenous antibiotics are universally used to prevent infection-related adverse events. there is no fixed protocol or duration of antibiotics for the same.

poem is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of natural orifice transluminal endoscopic surgery (notes). major adverse events during poem are rare and therefore, the procedure is considered safe. bacteremia can occur after endoscopic procedures like esophageal dilation, sclerotherapy of varices, and instrumentation of obstructed bile ducts. bacteremia has been advocated as a surrogate marker for risk of infection-related complications. in poem procedure, the endoscopist works in close proximity to mediastinum and peritoneal cavity. therefore, the potential for infection-related complications is high. however, despite of different antibiotic protocols at different centers, the reported incidence of infection-related complications is very low. at present, prophylactic antibiotics are universally initiated before starting the poem procedure and continued for a variable duration after poem ranging from 1 day to 7 days. data from surgical studies indicate that prolonged administration of antibiotics for longer than 24 hours may not be beneficial. prolonged use of antibiotics not only increases the costs and exposure to drug toxicity directly but also may be associated with an increased risk of acquired antibiotic resistance as well as infection with clostridium difficile. with this background, we planned a study to evaluate the difference in the infectious complications between short vs long duration antibiotic in patients with achalasia undergoing poem.

Eligibility criteria:
inclusion criteria: * all the patient(aged 18-65) who underwent poem for achalasia cardia. exclusion criteria: * unwillingness to give written informed consent * patients with multiple co morbidities. * immunocompromised patients /on steroid therapy. * patients with indications for antibiotic prophylaxis (infective endocarditis). * patients who have received antibiotics in the last 1 week . * patients who have possible signs of infection during preparation for poem

Keywords: oesophageal aperistalsis
the relationship between the surgery-related anxiety and hrv: prediction for aggressive emergence behavior

Conditions: Closed Reduction Surgery for Nasal Bone Fracture

Summary: heart rate variability (hrv) is known to reflect the balance of autonomic nervous system. anxiousness, which tend to result from the deficient action of parasympathetic nervous system, likely to show low hrv. this study is to investigate the relationship between the surgery-related anxiety and the hrv which is known to reflect the balance of autonomic nervous system. furthermore, this study also focuses on hrv's role as a predictor for aggressive emergence behavior, which might also be considered as partially related to imbalance of autonomic nervous system.


Eligibility criteria:
inclusion criteria: 1. 20-60 years old male, asa 1-2 2. scheduled for elective closed reduction for nasal bone fracture exclusion criteria: 1. patients having hearing difficulties, foreigner, taking any cns related medication, history of any adverse drug reaction, glasgow coma scale \< 15 2. patients with severe cardiopulmonary dysfunction 3. patients taking any neurologic medication (anti-depressant, anti-convulsant, etc) 4. patients taking any cardiovascular medication 5. patients taking medications affecting the autonomic nervous system (a-blocker, b-blocker, etc) 6. patients refusal

Keywords: emergence agitation, heart rate variability (hrv)
anxiety and copd evaluation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this prospective, multicenter, cohort study is designed to validate anxiety inventory respiratory disease questionnaire in patients with chronic obstructive pulmonary disease (copd). the primary purpose of this study is to assess the validity of the anxiety inventory respiratory (air) scale in detecting anxiety in relation to the dsm-v criteria in patients with copd. * to evaluate associations between copd symptom scores assessed by the cat questionnaire and mmrc dyspnea scale and measures of depression and anxiety * to evaluate associations between physiologic measures of lung function (spirometry) and exercise tolerance (6 minute walk) and measures of depression and anxiety * to evaluate associations between exacerbations of copd and the prevalence of anxiety and depression in a cohort of copd patients

the goal of the anxiety and copd evaluation (ace) study is to validate the air scale by employing the mini international neuropsychiatric interview to identify anxiety in 200 patients recruited at participating centers from the american lung association (ala) airways research network. confidential, not

Eligibility criteria:
inclusion criteria: * post-bronchodilation fev1 \< 80% of the predictive normal value and fev1 (forced expiratory volume in one second) / forced vital capacity(fvc) ratio \< 0.7 * clinically stable copd as defined by stable maintenance of copd medications and absence of an exacerbation of symptoms requiring treatment with an antibiotic or corticosteroids exclusion criteria: * exacerbation of respiratory symptoms in the past six weeks that resulted in the need for treatment or hospitalization * unstable coronary heart disease such as recent myocardial infarction (within 3 months), untreated arrhythmia, or unstable angina * major psychiatric disorders (except for depression and anxiety disorders) such as schizophrenia, schizoaffective, or other disorders that in the opinion of the study physician that would affect study participation * montreal cognitive assessment (moca) \< 18 * disease or condition expected to cause death within six months or inability to perform study procedures, as judged by study physician

Keywords: ace anxiety copd
prospective randomized trial of bactrim on 7 day outcome in patients with uncomplicated abscesses

Conditions: Abscesses

Summary: patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. all patients will receive incision and drainage and wound cultures. patients will then be randomized to 1) placebo two tablets po bid x 7 days or 2) bactrim ds (800/160) two tablets po bid x 7 days. patients will then return to the emergency department ed) at 48 hours and 7 for wound repacking and evaluation. the primary outcome is treatment failure rates at 7 days after incision and drainage. patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. data will be analyzed both by initial randomization and intention to treat.


Eligibility criteria:
inclusion criteria: * inclusion criteria include all patients age 16 and older who present to the emergency department with a skin abscess that requires incision and drainage. exclusion criteria: * exclusion criteria include patients with diabetes, hiv, cancer or other immunocompromised patients. * additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables. * pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment. * patients with abscesses on face, perirectal, or perianal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded. * patients with fever or evidence of systemic infection * finally, patients with sulfa allergy will be excluded.

Keywords: abcess mrsa cellulitis antibiotics uncomplicated abscesses
compliance of initial empiric antimicrobial therapy

Conditions: Anti-Infective Agents

Summary: hospital infections comprise about half of all undesirable complications related to hospital treatment. in case of bacterial infection administration of antimicrobial agent is a therapy of choice. for maximum effectiveness, antimicrobial agents should be administered quickly in optimal doses. moreover, the therapeutic concentration of properly selected drugs should be achieved as soon as possible. the relation between delays in the administration of antibiotics and increased mortality is well known. that is why proper empiric therapy is so important. before antimicrobial investigation is completed, which may last up to 72 hours, a wide-spectrum antimicrobial should be administered according to the type of infection, its origin, and the characteristics of the local pathogens. the objective of this study is to compare the initial choice of empiric antimicrobial therapy and the results of both microbiological identification and susceptibility/resistance analysis of isolated pathogens. this project was designed as a prospective cohort study. analysis was performed in a large multidisciplinary academic hospital and trauma center. all decisions on empiric therapy with antimicrobial used in infections caused by multidrug-resistant pathogens, that are made in different hospital wards except intensive care, are required by hospital procedures to be confirmed by intensivists. in our analysis, the initial choice of empiric therapy in the hospital wards other than the critical care unit was compared with the results of microbiological investigations and susceptibility/resistance analyses of isolated pathogens. accurate microbial identification was performed with a vitek® 2 automatic testing system. the microbroth dilution method with vitek® 2 ast cards was used for the antibiotic susceptibility testing of isolated pathogens. microbiological analyses were performed between 2018 and 2020 according to the regulations of the european committee on antimicrobial susceptibility (eucast, version 9.0, 2019) and the national reference centre for susceptibility testing (nrcst, warsaw, poland).


Eligibility criteria:
eligibility criteria: - all patients in whom, based on clinical signs and symptoms, an infection is suspected, and an administration of antimicrobial agents as empiric therapy was necessary eclusion criteria: - none.

Keywords: empirical therapy antimicrobial agents hospital infections
chinese pd-gba registry

Conditions: Parkinson Disease

Summary: the purpose of the chinese parkinson's disease with gba variants registry (cpd-gbar) is to develop a database of patients of parkinson's disease with glucocerebrosidase (gba) gene variants in mainland china.

parkinson's disease (pd) is the second most common disorder among neurodegenerative diseases. gba gene variants such as l444p can influence the risk of developing pd and these variants have the greatest impact on pd susceptibility among all the pd related gene variants yet discovered. the investigators aim to establish a database of pd with gba variants and characterize the clinical manifestation of these patients in mainland china. method: 1. peripheral blood from patients has been tested to have gba gene variants. 2. clinical manifestation will be measured by scales and neurological tests. standard scales include: unified parkinson's disease rating scale(updrs), hoehn-yahr stages, non-motor symptoms scale (nmss), mini-mental state examination (mmse), parkinson disease sleep scales (pdss), rapid eye movement sleep behaviour disorder questionnaire(rbdq-hk), epworth sleepiness scale (ess), rome iii functional constipation scale, the scale for outcomes in pd for autonomic symptoms (scopa-aut), parkinson fatigue scale (pfs), cambridge-hopkins restless legs syndrome questionnaire (chrlsq), hyposmia rating scale(hrs), hamilton depression scale, the 39-item parkinson's disease questionnaire(pdq-39), freezing of gait scale(fog), dyskinesia related scales, wearing-off scale(wo). 3. the investigators will also exam the blood biomarkers of pd such as uric acid and peripheral inflammatory markers.

Eligibility criteria:
inclusion criteria: * patients diagnosed with pd by the united kingdom parkinson's disease society brain bank clinical diagnostic criteria or other standard criteria; pd patients detected with gba gene variants. exclusion criteria: -
antero-5: gastric motility in postoperative ileus

Conditions: Postoperative Ileus

Summary: a monocenter, non-randomized interventional investigation in 3 panels of adult patients undergoing elective colorectal surgery who are at risk to develop postoperative ileus. the feasibility to use the vipun gastric monitoring system prototype 0.3 will be explored in this population for the first time.


Eligibility criteria:
inclusion criteria: * signed informed consent * at least 18 years old * bmi between and including 18 and 30 * understand and able to read dutch * planned to undergo elective colorectal surgery exclusion criteria: * known history of documented gastroparesis * known history of functional dyspepsia * known / suspected current use of illicit drugs * known psychiatric or neurological illness * any prior gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator * known history of heart or vascular diseases like irregular heartbeats, angina or heart attack * nasopharyngeal surgery in the last 30 days * suspected basal skull fracture or severe maxillofacial trauma * known history of thermal or chemical injury to upper respiratory tract or esophagus * current esophageal or nasopharyngeal obstruction * known coagulopathy * known esophageal varices
tracheal dosage of amylase : a new surrogate for microaspirations in ventilated icu patients

Conditions: Ventilated-acquired Pneumonia

Summary: microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff contribute to the constitution of vap. the pepsin has been recently proved effective as a surrogate of gastric content and was assessed in tracheal secretions. however, the pepsin dosage is fastidious, expensive and only characterizes aspirations from gastric origin. the aim of our study is to asses whether the value of amylase, which is mostly secreted by salivary glands, may turn out to be a new and simpler surrogate for microaspirations in ventilated icu patients. thirty patients ventilated for an anticipated length \> 48h whose endotracheal tube includes a subglottic secretion device and producing sufficient endotracheal aspirations will be included. from h48, 4 sets of 3 aspirations each (oral, subglottic, tracheal) will be performed during one ventilation day for amylase dosage purpose. in ten of these patients, a comparison between pepsin and amylase will be assessed. in addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a tracheal aspiration during the procedure will be included as a control group. the primary assessment criteria will be the oral/tracheal amylase ratio.


Eligibility criteria:
inclusion criteria: * intubated and ventlated patients group: patients ventilated with a tube including a subglottic secretion device for an anticipated length \> 48h and producing sufficient endotracheal aspirations * non intubated patients group: patients with an study-independant indication to bronchoscopy and necessitating a tracheal aspiration during the procedure exclusion criteria: * patients ventilated for less than 48h * patients developing ventilated-acquired pneumonia or bronchitis before potential inclusion * paralysed patients * patients requiring a closed suction device * patients with relative contraindications to endotracheal aspiration (status asthmaticus, severe ards with pf ratio \< 100, hemorragic risk, brochopleural fistula) * bronchiectasis, cystic fibrosis * moribund patient or ethical decision to withhold or withdraw intensive care.

Keywords: ventilator-acquired pneumonia prevention amylase tracheal aspiration microaspiration
a comparison of different community models of art delivery amongst stable hiv+ patients in two urban settings in zambia

Conditions: HIV Infections

Summary: the purpose of this study is to compare the virological and clinical outcomes of patients participating in community models of art delivery to the standard of care in an urban setting in zambia.

the outcomes of this study will be measured in a prospective cohort of adult patients enrolled into art care in two urban communities participating in the hptn 071 (popart) trial. the two community models are: 1) adherence clubs, groups of 20-25 stable patients who receive art care in the community every 3 months, and 2) home-based art delivery in which a community health worker delivers art care to an individual at home every 3 months. the standard of care is delivery of art care at the local clinic.

Eligibility criteria:
inclusion criteria: 18 years or older on first-line art and retained in care for more than 6 months virologically suppressed world health organization (who) stage i and ii at time of screening reside within the clinic catchment area willing to provide written informed consent and accept community hiv-care provider (chips) intervention exclusion criteria: -
long term extension trial of setmelanotide

Conditions: Obesity Associated With Defects in Leptin-melanocortin Pathway

Summary: this was a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in participants who had completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the melanocortin-4 (mc4) receptor in the leptin-melanocortin pathway.

the primary objectives of this extension trial were to explore the long-term safety and tolerability of setmelanotide for up to 7 years or until drug was otherwise available through authorized use. participants entered this protocol immediately upon completion of their index protocol such that dosing of setmelanotide continued without gaps in therapy.

Eligibility criteria:
key inclusion criteria: 1. participants aged 2 or older (or aged \>2 years as per local regulations) who had completed participation in a previous setmelanotide trial and demonstrated adequate safety and meaningful clinical benefit (efficacy) 2. participant and/or parent or guardian was able to communicate with the investigator, understand and sign the written informed consent/assent, and comply with the trial requirements 3. agree to use a highly effective form of contraception throughout the trial key exclusion criteria: 1. pregnant and/or breastfeeding women 2. significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion) 3. current, clinically significant disease 4. documented diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s) 5. suicidal ideation, attempt or behavior 6. history of significant liver disease 7. moderate to severe renal dysfunction as defined by a glomerular filtration rate (gfr)\<30 milliliters per minute (ml/min). 8. history or close family history of melanoma or participant history of oculocutaneous albinism other protocol defined inclusion/exclusion criteria may apply.

Keywords: setmelanotide rm-493 obesity leptin-melanocortin melanocortin 4 receptor
effectiveness of ehealth on the self-management of health status and qol among cad patients

Conditions: eHealth; Coronary Artery Disease; Quality of Life; Self-management

Summary: this article uses the smart medical case management tracking system, combined with various terminal devices to fully record the measured data (pulse, blood pressure) for case home care tracking to prevent the occurrence and deterioration of the disease. therefore, with the promotion of the ehealth medical staff and members of the family can instantly grasp the health of the body and cultivate the habits of self-health management and enhance the quality of care. therefore, we hope to use the smart health cloud as an interventional measure to improve the care of patients with coronary artery disease, improve self-management ability and quality of life.

the world health organization points out that cardiovascular disease is the number one killer of global deaths, killing 17.1 million people worldwide each year, accounting for 31% of the world's total deaths. heart disease is the second leading cause of death in china. coronary artery disease (cad) is the majority, and coronary artery disease is the most common cardiovascular disease. good self-management can reduce disease risk factors and improve related prognosis. it is also an important issue in health promotion around the world. this article uses the smart medical case management tracking system, combined with various terminal devices to fully record the measured data (pulse, blood pressure) for case home care tracking to prevent the occurrence and deterioration of the disease. therefore, with the promotion of the ehealth medical staff and members of the family can instantly grasp the health of the body and cultivate the habits of self-health management and enhance the quality of care. therefore, we hope to use the smart health cloud as an interventional measure to improve the care of patients with coronary artery disease, improve self-management ability and quality of life.

Eligibility criteria:
inclusion criteria: * a patient who is 20 years of age or older and has a coronary computed tomography angiography \>50% vascular stenosis, has been ptca、stent or cabg * taiwanese, understand chinese exclusion criteria: * those who can't express their wishes clearly (such as azheimer's disease, mental dysfunction) * mental disorder * infectious diseases * patients who participate in other research projects

Keywords: coronary artery disease remote care artificial intelligence self-management quality of life
a study in adult subjects with select advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: to evaluate the safety and tolerability of medi1873 in adult subjects with selected advanced solid tumors.

this is a first-time-in-human, phase 1, multicenter, open-label, single-arm dose-escalation study of medi1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies

Eligibility criteria:
inclusion criteria: * all subjects must consent to provide archived tumor specimen * subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease. * at the time of day 1 of the study, subjects with central nervous system (cns) metastases must have been treated and must be asymptomatic * willingness to provide pretreatment and on-treatment biopsies. * adequate organ function * females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception exclusion criteria: * known allergic reaction to any component of medi1873 * concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study * receipt of any anticancer therapy within 4 weeks prior to the first dose of medi1873; in the case of mabs, 6 weeks prior to the first dose of medi1873 * any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. * receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product * unresolved toxicities from prior anticancer therapy * any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.

Keywords: advanced solid tumors immunotherapy immuno-oncology