Kornimate/medical-research-clean huggingface dataset:
sex-specific differences in the stress response to abdominal aortic aneurysm repair

Conditions: Abdominal Aortic Aneurysm; Stress; Surgery

Summary: it is recognised that women are at greater risk of death, complications and longer hospital stay following intact abdominal aortic aneurysm (aaa) repair, and the reason for this is not yet established. this disparity in outcomes for women compared to men is also recognised in other forms of cardiovascular surgery, which raises the question of whether women and men are reacting differently to the stress of operative repair. this study aims to examine whether there are differences baseline stress markers and in the stress response to aaa repair between men and women. it will also examine whether markers of stress are associated with poor clinical outcomes and slower recovery (indicated by longer hospital stay). the study will take the form of an observational cohort study. it will not alter any of the treatment that men and women receive, but will monitor their stress levels using physiological markers (through ecg (electrocardiogram) monitoring using a non-invasive holter, biochemical markers using blood samples (which will be taken at the same time as routine testing, so as not to require further invasive procedures), and psychological testing, using short forms that the patient will be able to fill out independently at different stages of their recovery. clinical data will be used to look for relevant factors (clinical history or medications) which may alter the stress markers we are observing, and to compare outcomes with markers of stress. patients will be asked for their consent to share their data with the research team in order to participate in the study. it will be made clear that there will be no change in their clinical or operative management if they participate in the study and they will be able to withdraw consent for further participation at any time.


Eligibility criteria:
inclusion criteria: * men and women undergoing primary elective intact aaa repair, open or endovascular (evar) at participating centres. * capacity to consent. exclusion criteria: * participants undergoing a secondary or emergency aortic procedure, or procedure for alternative aortic pathology. * relevant confounding pathology such as hypothalamic-pituitary axis pathology (e.g. addison's disease). * lack of capacity to consent. * participants with pacemaker dependency, or a significant arrhythmia, will be excluded from analysis of heart rate variability, but will be included in the study for analysis of psychological and biochemical markers of stress. * participants on steroid treatment will also be excluded from analysis of biochemical markers but may be included for analysis of physiological markers and/or heart rate variability. * participants must be over the age of 50 (in order to facilitate capture of degenerative aortic aneurysmal pathology rather than an alternative aortic pathology e.g. traumatic, connective tissue disorder).
beige fat, energy, and the natriuretic peptide system

Conditions: Obesity

Summary: obese individuals experience an increased risk of cardiovascular and metabolic diseases. evidence from genetic studies indicate that the natriuretic peptide (np) system may protect against these diseases. np levels differ by obesity status and race has not been established in humans. thus, the investigators propose a study in which will quantify adipose tissue gene expression and energy expenditure in states of np deficiency in humans. the overarching postulate is that obese and black individuals have np deficiencies that contribute to less beige adipose tissue and lower energy expenditure.

obesity represents a serious public health burden. obese individuals experience increased risk of cardiovascular and metabolic cardiometabolic disease, including insulin diabetes, resistance, hypertension, and dyslipidemia. obesity and obesity-associated cardiometabolic dysfunction are significant contributors to morbidity and mortality in veterans. this indicates that obesity and cardiometabolic dysfunction are complex and multifactorial, and suggests that there are additional factors that contribute to the pathogenesis of obesity and its associated cardiometabolic risk that have been discovered. moreover, some of the pharmacologic therapies for obesity can have adverse cardiovascular effects. thus, it is crucial to improve the understanding of the multiple pathways contributing to the pathogenesis of obesity and obesity-associated cardiometabolic risk, including the identification of novel relevant pathways, in order to develop more effective treatments for these diseases. the proposed work will form a foundation for future high-impact studies of mechanisms for adiposity and cardiometabolic disease.

Eligibility criteria:
inclusion criteria: * men and women ages 18-55 years * body mass index (bmi) \>= 18.5 and \<25 kg/m2 (lean), or bmi 30 kg/m2 (obese) exclusion criteria: * significant pulmonary, liver, or renal disease * heart failure (any type) or unstable coronary artery disease * diabetes mellitus (types 1 and 2) * thyroid dysfunction * active malignancy * chronic inflammatory diseases, such as inflammatory bowel disease, hepatitis, rheumatoid arthritis * current use of medications likely to affect energy homeostasis, including glucocorticoids, amphetamines, and beta blockers * currently pregnant or breastfeeding, or unwilling to avoid becoming pregnant or breastfeeding during study duration * significant claustrophobia that would prevent the use of the metabolic cart as part of the study protocol * hemoglobin a1c (hba1c) \>= 6.5% * liver function tests (lfts) elevated \>3x upper limit of normal * estimated glomerular filtration rate (egfr) \<40 ml/min * currently abnormal thyroid stimulating hormone (tsh)

Keywords: adipose tissue beige adipose tissue cardiovascular physiology b-type natriuretic peptide metabolism obesity
ultrasound guided versus landmark guided small & medium joint arthrocentesis

Conditions: Effusion Joint

Summary: arthrocentesis is the removal of synovial fluid for analysis of pathologic processes. small \& medium joint arthrocentesis will be defined as the following joints: elbow, wrist, finger, ankle and toe. ultrasound (us) and landmark (lm) small \& medium joint arthrocentesis are both performed within the clinical setting. both techniques are considered standard of care. selection of which technique to use is dependent upon the physician's preference. there is currently limited data comparing the two methods. the investigators hope to determine if one modality is more effective in terms of success rate, number of attempts, and time to complete the procedure.

patients presenting to the emergency department who are 18 years old or older, who do not belong to a vulnerable group, requiring small or medium joint arthrocentesis will be included in this trial. the investigators will randomize each patient into lm vs us. data collected will include number of attempts to tap the joint, success rate, and time for procedure to be completed. the arthrocentesis will be performed by pgy-3 residents only. a 21 gauge needle will be used for the arthrocentesis.

Eligibility criteria:
inclusion criteria: * all patients who require an arthrocentesis of a small and/or medium joint (defined previously) exclusion criteria: * coagulopathic patients * patients on anticoagulants * patients with cellulitis overlying the joint. * patients with artificial joints * adults unable to consent * vulnerable populations
mechanisms of pharyngeal collapse in sleep apnea, study d

Conditions: Sleep Apnea

Summary: in obstructive sleep apnea (osa), the upper airway recurrently closes during sleep. the mechanisms that lead to airway closure are not completely understood. some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (progressive expiratory narrowing, pen) preceding an obstructive apnea. the investigators will assess the viscoelastic properties of the pharyngeal airway and its role in pen.

in obstructive sleep apnea, the upper airway recurrently closes during sleep. the mechanisms that lead to airway closure are not completely understood. some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (progressive expiratory narrowing, pen) preceding an obstructive apnea. the investigators will test how the viscoelastic properties of the airway influence pen. to this end, the investigators will visualize the pharynx of sleep apnea patients using a thin endoscope and will induce central apneas during sleep. pharyngeal cross-sectional area will be recorded during incremental changes in pharyngeal pressure during central apneas.

Eligibility criteria:
inclusion criteria: * normal subjects or patients with osa exclusion criteria: * any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems. * any medication known to influence breathing, sleep/arousal or muscle physiology * concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia) * claustrophobia * inability to sleep supine * allergy to lidocaine or oxymetazoline hydrochloride * for women: pregnancy

Keywords: sleep apnea pathophysiology
reduced fluence visudyne-anti-vegf-dexamethasone in combination for amd lesions (radical)

Conditions: Choroidal Neovascularization; Macular Degeneration

Summary: the objective of this study is to determine if combination therapy (reduced-fluence visudyne followed by lucentis \[within 2 hours\] or either of two regimens of reduced-fluence visudyne followed by lucentis-dexamethasone triple therapy \[within 2 hours\]) reduces retreatment rates compared with lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.


Eligibility criteria:
inclusion criteria: * treatment naive for choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd) in the study eye except for laser treatment outside the subfoveal area * subfoveal cnv due to amd * cnv must be = or \>50 % of the entire lesion * all lesion composition types with a lesion greatest linear dimension (gld) \< 5400 microns (approximately = or \<9 disc areas \[da\]) * best-corrected early treatment diabetic retinopathy study (etdrs) visual acuity (va score) of 25 - 73 letters (approximate snellen equivalent of 20/40 - 20/320), inclusive exclusion criteria: * subfoveal geographic atrophy or subfoveal fibrosis of the study eye * intraocular surgery within 3 months of enrollment * inability to attend the protocol-required visits * known allergies or hypersensitivity to any of the study treatments. * other systemic diseases or active uncontrolled infections that would make subject a poor medical risk * uncontrolled glaucoma, defined as (1)subject is on \>1 glaucoma medication (includes combination treatments) or (2)subject has glaucoma that could lead to progressive visual field deterioration * if subject has had a stroke within the last year

Keywords: macular degeneration amd cnv choroidal neovascularization photodynamic therapy cnv secondary to age related macular degeneration
long-term outcomes of patients after coronary bifurcation stenting

Conditions: Coronary Artery Disease; Death; Myocardial Infarction

Summary: the purpose of this study is to assess the long-term clinical outcomes after stenting bifurcation coronary artery lesions, and to determine whether simple or more complex techniques are associated with a better clinical outcome. we will also assess the risk factors associated with poorer clinical outcomes

coronary artery disease affecting the branch points of coronary arteries (bifurcation lesions) has a higher rate of restenosis after angioplasty than disease in regions not involving branch points. post-procedural angiographic outcomes and in-hospital outcomes have been documented for a variety of techniques, but none have examined the long-term clinical outcomes. long-term clinical outcomes are important from the patients point of view and also determine the use of resources. knowledge of the long-term outcomes from the various techniques used to treat bifurcation lesions would be important in determining guidelines for the treatment of bifurcation lesions. if simple techniques offer similar or better outcomes than more complex strategies, then this would justify simpler techniques such as main vessel stenting that would use less resources, expose the patient to less radiation, and contrast related to prolonged angioplasty procedures. comparisons: we will compare the long-term outcomes of simple versus complex stent techniques, and determine other risk factors for long-term outcome

Eligibility criteria:
inclusion criteria: * de novo coronary artery lesion in a main branch with at least a 50% stenosis * lesions involve the ostium of a side branch artery * main branch and side branch with reference diameters of at least 2mm * at least one stent used to treat the lesion exclusion criteria: * restenosis lesions * reference side branch artery less than 2mm diameter * multiple bifurcation lesions

Keywords: coronary artery disease bifurcation lesions percutaneous interventions stenting outcomes death myocardial infarction
improving asthma care together (impact): a shared management pilot study

Conditions: Asthma in Children

Summary: this study aims to iteratively develop, refine and test the improving asthma care together (impact) intervention for school-age children (7-11 years) with persistent asthma and their parents.

asthma is one of the most common chronic conditions of childhood, affecting over six million us children. asthma treatment relies on self-management including symptom monitoring and response, trigger avoidance, and timely and appropriate medication use. unfortunately, fewer than 50% of children with asthma are adherent to asthma treatment regimens, leading to increased disease morbidity and mortality and potentially irreversible airway damage. children with asthma are missing a voice in their own care. the school-age years (7-11) represent a natural transition in asthma management, as children must assume some responsibility for asthma-related care while they spend increasing time away from parents at school and other extracurricular activities. yet, existing interventions focus on parents alone and use prescriptive approaches, telling the parent what to "do" to the child to manage their asthma. as a result, current strategies are failing to provide children with asthma and their families the tools they need to manage asthma successfully within the realities of their daily lives. using a human-centered design (hcd) framework, the investigators co-designed a tailored asthma shared management mobile health application that pairs the parent and child together as a team and facilitates the intentional transition of some asthma management to the child. the hypothesis is that by involving children in their own care, participants will improve asthma management in the present, but also establish lifelong successful self-management skills. the objective of the proposed study is to pilot test the improving asthma care together (impact) mobile health application with parent-child dyads. based on the preliminary data, the central hypothesis is that impact will be effective for delivering a shared asthma management intervention for children and their parents.

Eligibility criteria:
child inclusion criteria: * clinician diagnosis of persistent asthma (prescription for daily asthma medication) * speak english parent inclusion criteria: * 18 years or older * child's primary caregiver * able to understand and read english * reside with the child 50% or more * legal guardian who can consent for child to participate * have access to a smart phone and reliable home internet access * reported asthma responsibility questionnaire score \< or = 2.5 at screening child exclusion criteria: * parent report of developmental delay (language \< 5 year level) * co-morbid cancer, diabetes, attention deficit hyperactivity disorder (adhd) * current asthma exacerbation at the time of recruitment

Keywords: self-management shared management mhealth
substantial equivalence of islpr™ and somnodent® classic in the treatment of snoring and mild to moderate sleep apnoea.

Conditions: Sleep Apnea; Snoring

Summary: the study is a thirty three week, prospective, open-label, randomized, parallel-group non-inferiority study. the study aims to investigate the substantial equivalence of a novel mandibular device called islpr™, produced by bioanalytics, to a currently approved device, somnodent® classic, in the treatment of mild to moderate obstructive sleep apnoea (osa) and snoring.

the objective of this study is to determine if the bioanalytics device, islpr™, has a similar safety and efficacy profile to a commonly used device, somnodent® classic, in the treatment of snoring and mild to moderate obstructive sleep apnoea. the target population will be males and females aged from 18 years to less than 75 years, who have been diagnosed with snoring and mild to moderate sleep apnoea. participants will remain on study from screening visit to end of study visit; a total of approximately 33 weeks. this study includes - * a screening period of up to 28 days * a 2 week device initiation period * a 24 week treatment period

Eligibility criteria:
inclusion criteria: * 18 years or older and younger than 75 years at time of screening * snoring and mild to moderate sleep apnoea ( ahi \> 5 and \< 30 per hr) * written informed consent * able to complete the study procedures within the study timeline. exclusion criteria: * women who are pregnant or breast-feeding * central sleep apnoea * severe respiratory disorders * loose teeth or advanced periodontal disease * lateral bruxers * full or partial dentures * temporomandibular joint (tmj) abnormalities, pain or dysfunction * other teeth, jaw or gum disorders would preclude use of the device * cardiovascular comorbidities or stroke/heart attack in past 12 months * drug-addiction * major depressive disorder or psychosis * undergoing concomitant therapy for osa/snoring * current or previous therapy with somnodent classic * professional drivers or machine operators required to be undertaking cpap
hr-qol and sexuality in mirena inserted contraception users

Conditions: Contraception

Summary: the purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with mirena, a hormonal contraceptive intra-uterine system, over the first 12 months of use. patients switching from oral contraception to an intrauterine contraceptive device (here: mirena) will be observed in the first year post mirena insertion.


Eligibility criteria:
inclusion criteria: * healthy woman willing to, or having to switch from her oc to another contraceptive method exclusion criteria: - any contraindication to mirena insertion/use

Keywords: intra-uterine contraception intrauterine devices
a study of intravenous or subcutaneous mircera for the treatment of anemia in dialysis patients

Conditions: Anemia

Summary: this study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. the anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * chronic renal anemia; * on dialysis therapy for at least 12 weeks before screening; * receiving iv or sc epoetin for at least 8 weeks before screening. exclusion criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of another investigational drug within 4 weeks before screening, or during the study period.
optiluts part c: the development of a symptom assessment tool in sacral neuromodulation.

Conditions: Overactive Bladder Syndrome; Urinary Retention; Dysfunctional Voiding; Fecal Incontinence; Fowler Syndrome

Summary: sacral neuromodulation (snm) is a two-staged 2nd-line therapy for therapy-resistant luts and fecal incontinence. currently, the assessment of symptoms at baseline and after stage i is directed towards a discipline related evaluation. the optiluts trial strives for a more holistic approach, taking all pelvic floor dysfunctions into account. a holistic assessment tool will be developed and snm-care pathway will be set-up.

a prospective single centre trial is set up. patients planned for the two-staged tined lead procedure are enrolled. bladder and bowel diaries and patient reported outcome measures (proms) will be collected at baseline and in between stage i and stage ii, and proms at one month, 6 months and 12 months after definitive implant. phase i step 1: the current implant rate, true success rate, outcomes and false positive rate will be measured. step 2: development of a holistic symptom assessment tool. phase ii implementation of the snm care pathway.

Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years presenting with one or more of the following indications: urinary urgency frequency with or without urinary incontinence (oab dry or wet), non-obstructive urinary retention, dysfunctional voiding with post void residual volume, faecal incontinence and mixed incontinence * refractory to conservative treatment (i.e. lifestyle changes, behavioural modification, pelvic floor muscle training, biofeedback) and refractory to pharmacological treatment. exclusion criteria: * neurogenic bladder. * anal sphincter damage more than 120 * abnormal sacral anatomy * mentally or physically disabled patients not capable to handle a patient programmer device. * pregnant patients

Keywords: sacral neuromodulation
the inperia advance post-market retrospective study

Conditions: Peripheral Arterial Disease

Summary: the inperia advance carbostent™ is a ce-marked infra-popliteal stent for treatment of infra-popliteal artery stenosis. the aim of this post-market retrospective study protocl p32203 is to collect clinical data of patients treated with inperia advance for the treatment of infra-popliteal artery stenosis in routine clinical practice. in order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with the device at least 12 months prior to the study start.

the objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical device inperia advance in the daily clinical practice in an unselected population treated within the intended use. data will be collected via medical chart review in anonymous form to assess the safety and efficacy of inperia adavance. the inperia advance carbostent™ is a ce-marked infra-popliteal stent for treatment of infra-popliteal artery stenosis.

Eligibility criteria:
inclusion criteria: * patient has been implanted with at least one inperia advance device according to the indications described in the instructions for use (ifu). * study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection. exclusion criteria: * patients treated less than 12 months prior to study start