Kornimate/medical-research-clean huggingface dataset:
physiology and structure of the small airways in patients with chronic airflow obstruction or covid-19

Conditions: Copd; COVID-19; Asthma; Small Airways Disease

Summary: the purpose of this research project is to study small airways physiological function in patients with chronic obstructive lung disease or covid-19 and explore the relationship with in-vivo microanatomical small airway structure as measured by oct. correlating endobronchial assessment with multiple breath nitrogen washout and impulse oscillometry will allow the characterisation of the relationship between small airway structural findings and these validated investigations. a small volume lung wash, endobronchial brushings and the collection of a limited number of endobronchial cryobiopsy samples will be performed to better understand the endobronchial environment of the small airways through inflammatory studies. following the completion of any such work, residual samples will be stored in a "bio-bank" to enable the completion of future work. understanding the relationship with symptom-based quality of life scoring questionnaires and a functional assessment of exercise capacity will help elucidate the clinical impact of in-vivo small airways findings.


Eligibility criteria:
inclusion criteria: 1. age 16 or over 2. scheduled for bronchoscopy as part of clinical care or research protocol 3. no bleeding diathesis or therapeutic anticoagulation 4. copd: * fev1/fvc ratio \<70% or asthma: * diagnosed by standard clinical methods * post-bronchodilator fev1 ≥60% predicted or covid-19 infection or previous covid-19 infection (confirmed as per local guidelines) exclusion criteria: 1. unable to provide informed consent 2. exacerbation of obstructive airways disease or respiratory infection requiring systemic antibiotics or corticosteroids in the 6 weeks prior to enrolment unless suffering from covid-19 infection and bronchoscopy is required for clinical reasons 3. contra-indications to performing lung function testing * aortic aneurysm \>6cm * unstable cardiovascular disease (unstable angina, myocardial infarction or pulmonary embolism \<4 weeks prior) * severe aortic stenosis * pneumothorax * cerebral aneurysm * thoracic or abdominal surgery \<4 weeks prior 4. contra-indications to passing oesophageal balloons * oesophageal ulceration or varices * sinusitis, recent nasal surgery or epistaxis
early percutaneous tracheostomy and swallowing dysfunction

Conditions: Swallowing Disorder

Summary: the aim of the study is to determine if performing an early tracheostomy (within the first 4 days of endotracheal intubation) in critically ill patients on mechanical ventilation, reduces the incidence of swallowing dysfunction.

the development of initial resuscitation maneuvers, associated with a better knowledge of the physiopathology of critical illnesses and the technological development experienced by critical care medicine, allow us to give vital support to patients for long periods of time. in this scenario, a considerable proportion of critically ill patients may require translaryngeal intubation and invasive mechanical ventilation. patients who require prolonged translaryngeal intubation have a high risk of developing swallowing dysfunction, a condition predisposing to secretions aspiration. until now, there has been no demonstration of a causal association between the duration of translaryngeal intubation and development of swallowing dysfunction. however, all the studies about this topic have been performed on patients submitted to prolonged translaryngeal intubation. clinical studies have documented the development of early laryngotracheal lesions after intubation, which might explain post extubation dysfunction of swallowing reflex, probably as consequence of alteration of mechanic and chemo-receptors of the pharyngeal and laryngeal mucosa. there are no studies evaluating the impact of an early percutaneous tracheostomy on the incidence of swallowing dysfunction in critical care patients. the investigators have documented a 38% of swallowing dysfunction in our critically ill patients submitted to prolonged mechanical ventilation. the hypothesis of the study is that performance of an early percutaneous tracheostomy, within the first 4 days of translaryngeal intubation, in critical care patients on mechanical ventilation, reduces the incidence of swallowing dysfunction. the diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (fees) by a trained otolaryngologist, 3 to 5 days after weaning of mechanical ventilation.

Eligibility criteria:
inclusion criteria: * written informed consent has been obtained for the procedure * patients whose need of mechanical ventilation is estimated in ≥ 7 days and require a percutaneous tracheostomy exclusion criteria: * patients younger than 18 years old * patients with neurologic pathology * patients with dysphagia history * patients whose mv duration is estimated in \< 7 days * patients with airway obstruction requiring an emergency tracheostomy * patients already having a tracheostomy in situ * pregnancy * patients who have already been enrolled on another trial * patients with absolute contraindication to perform a percutaneous tracheostomy * patients with high risk of dying, life expectancy of \< 48 hours * patients in whom limitation of therapy has been decided * family rejection to participate in the study

Keywords: percutaneous tracheostomy swallowing dysfunction mechanical ventilation intensive care
worksite issues in organizational health promotion (take heart)

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to evaluate the impact of organizational-level health promotion activities and worksite characteristics on employee dietary and smoking behaviors.

design narrative: based upon the organizational literature on adoption and institutionalization of innovative practices, a disseminable intervention protocol and materials (e.g., a guidebook for worksite health promotion steering committees) was developed. this intervention was evaluated in a randomized control trial comparing 13 treatment worksites to 13 delayed-treatment worksites on organizational health promotion practices (policies/environmental control, incentive programs, skills training activities, maintenance activities); employee smoking cessation and saturated fat consumption; and employee cholesterol levels. following a two-year assessment, worksites in the delayed-treatment condition received a version of the intervention requiring less interventionist time. the effects of this streamlined intervention in these worksites were evaluated relative relative to a third group of 13 quasi-experimental comparison worksites that entered the study at that time. the study also evaluated the impact of organization characteristics and health promotion activities on employees at various stages of health related behavior change (awareness, intention to change, behavior change attempt, maintenance of behavior change). process measures assessing program implementation and cost-effectiveness data were collected. finally, the long-term intervention effects (3-4 years following initial intervention) on organizational health promotion practices, employee dietary and smoking behaviors, and cholesterol levels were assessed. in summary, this five year project provided both a) knowledge about how to implement worksite health promotion interventions to promote employee ownership and maintenance, and b) disseminable intervention products (e.g., protocols and employee steering committee guidebooks).

Eligibility criteria:
no eligibility criteria
bone graft materials observational registry

Conditions: Degenerative Disc Disease; Herniated Disc; Spinal Stenosis; Spondylolithesis; Spinal Deformity; Cervical Myelopathy; Failed Back Surgery Syndrome; Spinal Cord Neoplasms

Summary: a multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.


Eligibility criteria:
inclusion criteria: * the patient has failed conservative treatment and is a candidate for spinal fusion surgery. * the patient is ≥18 years old and of legal age of consent. * the patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent. * the patient is skeletally mature (epiphyses closed). * the patient has signed the irb approved informed consent. * the patient is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years. exclusion criteria: * patient has systemic infection or infection at the surgical site. * patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.). * patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease). * patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up. * the patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study. * patient is participating in another investigational study, which could confound results.

Keywords: bone growth substitute autograft allograft spine fusion
mindfulness based relapse prevention for stimulant users

Conditions: Stimulant Dependence

Summary: the broad, long-term objective of the current research is to improve treatment for stimulant use disorders by augmenting traditional relapse prevention therapy with innovative meditation-based strategies to promote affect regulation skills. based on mindfulness-based cognitive therapy for depression (segal, teasdale, \& williams, 2002), marlatt and colleagues recently developed a manualized intervention for the treatment of substance using populations: mindfulness based relapse prevention (mbrp). the specific aims of this research are 1) to conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large scale study and to determine the effect size of mbrp relative to a health education (ed) control group in stimulant users receiving contingency management (cm).

both mbrp and ed participants will be assessed at baseline, treatment-end, and 1 month post-treatment. 2) to test the impact of mbrp compared to ed on negative affect, stimulant use, and health care outcomes. 3) to evaluate the differential effects of mbrp versus ed on hiv-risk behavior of participants, and 4) to examine potential mechanisms of action of mbrp, including reductions in stress reactivity and biological indicators of arousal such as blood pressure and heart rate. the investigators hypothesize that mbrp will be more efficacious than ed in reducing negative affect and stimulant use. further, the investigators expect that mbrp will produce greater reductions in hiv-risk behaviors, stress reactivity, and arousal, and these changes will be associated with substance use outcomes. mbrp incorporates specific substance-focused cognitive therapy techniques with an additional emphasis on mindfulness skills. by providing coping skills to address affect regulation and stress reactivity, two important factors in stimulant relapse, mbrp may provide a promising augmenting strategy for the treatment of stimulant users.

Eligibility criteria:
inclusion criteria: 1. age 18 to 59 2. dsm-iv diagnosis of stimulant dependence 3. able to provide informed consent 4. willing and able to participate in study procedures exclusion criteria: 1. presence of life threatening or unstable medical illness, such as acute pulmonary, cardiovascular, or musculoskeletal disease, that would require treatment or make study participation difficult 2. lack of proficiency in english 3. currently homeless (unless residing in a recovery home for which contact information can be provided) 4. dependence on an illicit substance for which medical detoxification is imminently needed. 5. presence of clinically significant psychiatric symptoms as assessed by mini, such as psychosis or acute mania, that would require ongoing treatment or make study compliance difficult.

Keywords: stimulant addiction mindfulness treatment
review of the literature and serie of patients who underwent reconstruction after wide local excision of nail apparatus for melanoma

Conditions: Melanoma

Summary: melanomas of the nail bed are often diagnosed at the locally advanced stage. the standard treatment was amputation of the finger or toe, but it has now been established that enlarged excision of the nail plate is sufficient under certain conditions. reconstruction of the nail system can be performed by several techniques. here, the investigators present a series of patients reconstructed by integra (dermal matrix) and skin graft


Eligibility criteria:
inclusion criteria: * patients who have undergone enlarged resection of the nail apparatus with immediate or delayed reconstruction in the setting of acral melanoma of the fingers or toes. exclusion criteria: * patients who have amputation, opposition of the pateint to the study.
sleep apnea and hypertrophic cardiomyopathy (hcm)

Conditions: Hypertrophic Cardiomyopathy

Summary: the investigators are trying to find out how common sleep apnea is in hypertrophic cardiomyopathy. the purpose of this study is to see if sleep apnea is common in hypertrophic cardiomyopathy and if its presence is associated with changes in the functioning of the body. the investigators want to determine if sleep apnea is associated with electrical disorders of the heart in patients with hypertrophic cardiomyopathy.

participants will be healthy volunteers or subjects with the diagnosis of hypertrophic cardiomyopathy (hcm). all patients will a undergo a one time; medical history, physical examination, questionnaires, sleep observation in hospital, blood and urine samples, ultrasound scan of the heart, paced breathing test, ultrasound of brachial artery in the arm, mri of the heart \& 48 hour ecg holter monitoring. comparison between the normal volunteers and subjects with hcm will be made.

Eligibility criteria:
inclusion criteria: * adults with a diagnosis of hcm * able to consent * non-pregnant * healthy controls free of hypertrophic cardiomyopathy and without a definitive family history of hypertrophic cardiomyopathy. exclusion criteria: * decompensated heart failure at time of enrollment (prior history of hf is not an exclusion criteria) * severe (known) chronic obstructive pulmonary disease (copd) (fev1 between 30 and 50 percent of normal) * vulnerable study populations except for minorities (minorities may be targeted to achieve 25% minority recruitment required by the nih) * pregnant women * children

Keywords: sleep apnea arrhythmia
hemosonics-uva spinal surgery

Conditions: Deformity of Spine

Summary: this study compares the results of current standard coagulation measurement devices to the quantra system, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.

hemosonics is developing a novel poc diagnostic device, the quantra system, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. the quantra system employs a patented technology named sonorheometry, which was invented at the university of virginia. sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. the initial assay performed on the quantra system will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients. a clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology

Eligibility criteria:
inclusion criteria: * • subject is scheduled for major deformity correction spine surgery * subject is older than 18 years * subject is willing to participate and he/she has signed a consent form exclusion criteria: * • subject is unable to provide written informed consent * subject is incarcerated at the time of the study * subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks * subjects with renal disease (defined as serum creatinine greater than 1.5 mg/dl) * subjects with history of active liver disease * subjects affected by factor v leiden mutation * subjects affected by von willebrand disease * subjects with an history of thrombotic disease (more than one dvt)
azithromycin microspheres in patients with low risk community acquired pneumonia

Conditions: Community-Acquired Pneumonia

Summary: the study will assess the clinical efficacy at day 14-21 (test of cure), 14-21 days after starting the study drug; those subjects from whom a baseline pathogen is identified will also be assessed for bacteriologic response. all subjects who receive 1 dose of study medication will be assessed for safety.


Eligibility criteria:
inclusion criteria: * male or female, 18 years age or older, for whom oral, outpatient therapy is indicated. * diagnosis of cap as manifested by at least 3 or more of the following: * cough, pleuritic chest pain, fever (temperature of \>37.8 c to \ 10,000/mm3 or greater than 15% immature neutrophils (bands) exclusion criteria: * known or suspected hypersensitivity or intolerance to azithromycin or other macrolides. * previously diagnosed disease(s) of immune function, including: subjects with baseline absolute neutrophil count \< 1,000/mm3, hiv positive subjects with cd4 count \< 200 cells/mm3, any immunoglobin or neutrophil disorder.
topical mitogenic-activated protein kinase (mapk) inhibition in rosacea

Conditions: Rosacea, Erythematotelangiectatic

Summary: this is a prospective, vehicle controlled, double blinded study to evaluate the safety and potential efficacy of a topical formulation of a mek inhibitor in patients with erythematotelangiectatic rosacea

the duration of the study will be 22 days. subjects will use a cream with a mitogen-activated extracellular signal-regulated kinase (mek) inhibitor on one cheek, and a cream lacking the inhibitor (vehicle control) on the other. patients will receive a randomized set of creams for the right and left cheek, one containing the active ingredient. subjects will be evaluated on days 1, 8, 15 and 22. skin appearance will be scored in each visit. a blood sample will be obtained to determine the levels of systemic drug absorption.

Eligibility criteria:
inclusion criteria: * erythematotelangiectatic rosacea diagnosed by a clinician in the centrofacial and/or ocular regions. exclusion criteria: * other concurrent diseases for which treatment is being received that would preclude the use of trametinib (i.e., pleural effusion, active infection, intracranial bleeding) * history of skin allergic reactions or documented allergic reaction to trametinib * pregnancy or lactation. * heart failure or other heart disease * active use of medications with known documented interactions with trametinib (chloroquine, ritonavir, loperamide, penicillamine)
biobehavioral correlates of acute phobic fear

Conditions: Phobia

Summary: this study seeks to measure the time course of circulating proinflammatory markers (interleukin-1 beta \[il-1β\], interleukin-6 \[il-6\], tumor necrosis factor alpha \[tnf-α\], and c-reactive protein \[crp\]) and salivary alpha amylase (saa) following laboratory fear arousal. further, this study seeks to implement neurocognitive, physiological, and self-report measures to explore the role of threat sensitivity as a predictor of this response. the broad research question seeks to better understand the relationship between neurocognitive fear and subsequent stress responding elicited by both the immune system (i.e., proinflammatory markers) and autonomic nervous system (i.e., saa). in light of these aims, the primary outcomes of the current study are the proinflammatory markers (il-1β, il-6, tnf-α, crp), while secondary outcomes consist of saa, neurocognitive measures (i.e., dot-probe task), physiological correlates (i.e., heart rate, galvanic skin response), and self-report measures.


Eligibility criteria:
inclusion criteria: * 18 - 40 years old * phobic or nonphobic fear of spiders. * willing to proceed through 5-stimulus fear hierarchy or maintain 7 or higher subjective units of distress through fear task (see procedures section). exclusion criteria: * lifetime history of serious mental illness * lifetime history of intellectual or developmental delays * lifetime history of chronic physical or medical illness including blood clotting disorders * lifetime history of allergies to latex * lifetime history of hormonal replacement therapy * lifetime history of blindness * lifetime history of blood/injection phobia or aversion to needles/injection (based on ips-anx and mq) * substance abuse in the past 2 years * cigarette/tobacco use in the past 2 years * major depression within the past 12 months * traumatic stress within the past 12 months * pregnancy within the past 12 months * anesthesia within the past 3 months * night shift work within the past month * use of medication within the past month (except for oral contraception) * acute illness or infection within the past month * average sleep outside of 6 - 10 hours per night within the past month * average intake of 4 or more alcoholic beverages per week * average intake of 6 or more cups caffeine per day * use of marijuana within the week before the laboratory session * use of alcohol within the week before the laboratory session * body mass index outside of 18.5 - 24.9 range
basic intermittent exotropia and risk factors for postoperative overcorrection and under correction

Conditions: Strabismus

Summary: to evaluate preoperative risk factors for overcorrection and undercorrection following surgery for basic intermittent exotropia such as axial length of the globe, refractive error, age and sex


Eligibility criteria:
inclusion criteria: * basic type intermittent exotropia exclusion criteria: * previous strabismus surgery restrictive strabismus