Kornimate/medical-research-clean huggingface dataset:
phase iii study of florbetaben (bay94-9172) pet imaging for detection/exclusion of cerebral β-amyloid compared to histopathology

Conditions: Alzheimer Disease

Summary: to determine the sensitivity and specificity of the visual assessment of tracer uptake in the florbetaben pet images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth


Eligibility criteria:
inclusion criteria: * females, no child-bearing potential or negative urine pregnancy test on day of bay94-9172 injection * exhibits visual, auditory, and communicative capabilities adequate to provide informed consent or assent and comply with study procedures * is willing and able to lie down in magnetic resonance imaging (mri) and positron emission tomography (pet) scanners * is willing to donate their brain for postmortem examination in case of death * the subject, or the subject and/or legally acceptable representative will be compliant and have a high probability of completing the study in the opinion of the investigator * has been fully informed about the study, including provisions of the health insurance portability and accountability act (hipaa), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative * the subjects who have participated in a previous florbetaben study e.g. study 311741 may be included in the present study. the mri- and florbetaben pet scan do not need to be repeated if both scans were performed within twelve months prior to inclusion. exclusion criteria: * has severe cerebral macrovascular (ie, multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by mri * has any contraindication to magnetic resonance imaging (mri) examination, eg, metal implants or phobia as determined by the onsite radiologist performing the scan * has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study * has severe cardio-vascular instability requiring intensive care surveillance and/or therapeutic intervention (i.e. catecholamine infusion)

Keywords: florbetaben amyloid beta-protein alzheimer's disease
prospective randomized evaluation of a two and three piece total ankle replacement

Conditions: Ankle Osteoarthritis

Summary: this is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the star or salto-talaris prothesis.


Eligibility criteria:
inclusion criteria: * adult patients (age \> 18 years) who will benefit from a total ankle replacement, as determined by drs. nunley, deorio, or easley, with the aid of the physical exam and routine radiography treated at duke university medical center and who have no medical conditions that would represent contraindications to surgery or anesthesia will be asked to participate in this study. exclusion criteria: * the only excluded patients will be those who do not choose to participate in this study, have a weight greater than 250lbs, or do not meet the minimum age of 18 years.
culturally-responsive curriculum for caregivers with children at autism likelihood

Conditions: Autism; Development Delay

Summary: the goal of this clinical trial is to examine how helpful and relevant the family care project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. the main questions this trial aims to answer are: * is the family care project workbook useful for families? * is the family care project workbook easy to use? * can the family care project be implemented by non-profit workers who do not have health backgrounds? participants will complete surveys that elicit their feedback on their use of the workbook.

access to early, evidence-based autism-specific treatment can profoundly improve long-term outcomes for children with autism spectrum disorder (asd). however, current estimates reveal an eight-month to three-year gap between caregiver first concerns about their child's asd-related behaviors and receipt of asd-specific services. this prolonged time-period between caregiver first concerns and receipt of asd-specific services is characterized by elevated parenting stress, increased child behavioral challenges, and reduced quality of life, even compared to families of children with non-asd developmental concerns. unfortunately, culturally and linguistically diverse (cald) communities experience lengthier time-periods between first concerns and receipt of services, report increased difficulty accessing timely diagnostic and treatment services, and ultimately experience worse health outcomes compared to white communities. the investigators will partner with mother africa, a local non-profit organization, to 1) co-design culturally-responsive caregiver-focused educational materials to support cald families with young children who have social communication delays or asd and 2) develop a novel route for dissemination of information and materials within non-profit organizations, which are often the preferred entry-point for accessing healthcare information and services for underserved populations, rather than traditional medical facilities. the educational materials will support caregiver and child well-being by increasing caregiver knowledge and use of asd specific parenting strategies as well as increasing caregiver awareness and use of local asd resources. this planned research has the potential to effect programmatic changes in the services and settings available to support cald communities during the early years of a child's asd condition and thereby improve child and caregiver outcomes.

Eligibility criteria:
inclusion criteria: * has a child who screens at likelihood on the ages and stages questionnaire * speaks one of the following languages: arabic, mai mai, swahili, french, tigrinya, dari exclusion criteria: -
wound management for sacral pressure ulcers with necrotic tissue

Conditions: Pressure Ulcers

Summary: evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds

pressure ulcers on the sacral area will be applied with either a wound debridement product or a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3 week period of treatment.

Eligibility criteria:
inclusion criteria: * male or female subjects of any age * sacral wounds with necrotic tissue exclusion criteria: * 3rd degree burns * know hypersensitivity to products

Keywords: skin ulcers
early liver support with mars in post-hepatectomy liver failure

Conditions: Liver Failure as A Complication of Care

Summary: this is a prospective, randomized, open-label, multicentre study involving european centers with experience in the management of phlf to assess the impact of early liver support with mars on survival in patients with post-hepatectomy liver failure (phlf).

phlf is a major risk factor for mortality in patients who underwent major hepatectomy. a specific treatment is yet not available. in a primary proof-of-concept study, it was shown that it is safe and feasible to use mars in patients with phlf early after hepatectomy. survival was superior to a historical control group. this study will include patients with early, primary phlf (based on the 50:50 criteria) after major liver surgery. patients will be randomized 1:1 to receive standard treatment alone or standard treatment + liver dialysis using the molecular adsorbent recirculating system (mars). relevant outcome along with several physiological parameters will be assessed.

Eligibility criteria:
inclusion criteria: * patients subjected for major liver surgery (4 or more couinaud segments) or patients undergoing a 2nd, 3rd or 4th hepatic resection. pre-operative chemotherapy and/or biological agents are allowed. * primary phlf occurring early after surgery defined by the 50:50 criteria (from po day 5 to day 14) or by the presence of hepatic encephalopathy grade 2 or more and the 50:50 criteria (from po day 3 to 4). * written informed consent. exclusion criteria: * alpps (associating liver partition and portal vein ligation for staged hepatectomy) procedure. * in patients with chronic liver disease presence of significant portal hypertension (hepatic venous pressure gradient ≥ 10 mmhg and/or fibroscan ≥ 21kpa) prior to surgical intervention. * any contraindication for mars therapy such as uncontrolled active bleeding, platelet counts \ 1mg/h). * phlf occurring after post operative day 14. * secondary phlf: post-operative liver failure secondary to vascular (outflow or inflow thrombosis) or septic problems. * persistant biliary complications (infected biloma, main biliary tree damage). * inability or unwilling of the patient or family to give informed consent.

Keywords: molecular adsorbent recirculating system post-hepatectomy liver failure liver dialysis post-hepatectomy liver dysfunction
craniofacial imaging with 3d mri: an alternative to ionising radiation

Conditions: Craniosynostoses; Synostosis; Skull Deformity

Summary: craniosynostosis is a condition where infants are born with or subsequently develop an abnormally shaped skull. the skull develops from plates of bone separated from each other by growth lines (sutures). craniosynostosis refers to early fusion of one or more of these sutures. whilst in many cases the abnormal head shape provides doctors with the underlying diagnosis, it is necessary to confirm this using imaging. a ct scan involves using multiple x-rays to build a picture of the part of the body being examined. x-rays are associated with potential long term harm, particularly in young children who have longer to incur those risks. mri uses magnets and radiowaves to create images of the body, and therefore a radiation-free method of imaging. the investigators have previously shown in a pilot group that a specific mri technique ("black bone") can distinguish between normal and prematurely fused cranial sutures, and that the images can be reconstructed in 3d in the same way as ct. the investigators now need to confirm the findings in a larger patient group, and develop automated methods of creating 3d images of the bone. children in whom there is clinical suspicion of craniosynostosis will be recruited for mri examination. in children who are already undergoing mri examination of the head (for any indication), the investigators will add on bone specific sequences. there are no known long term risks associated with mri, and no contrast medium is required. anonymised mri data will be used to further develop our 3d techniques.


Eligibility criteria:
inclusion criteria: * children in whom craniosynostosis is clinically suspected exclusion criteria: * children with contraindications to mri examination * children who require sedation/anaesthesia solely for the purpose of research mri

Keywords: image reconstruction medical imaging magnetic resonance imaging imaging, three-dimensional
continued study of artificial vision: evaluation of the brainport® system and investigation of visual ambulation

Conditions: Blindness

Summary: the purpose of this study is to evaluate the use of an artificial vision system called brainport system in blind patients to investigate visual, and oculomotor (eye motion) mechanisms involved in the use of the brainport system.

the prevalence of blindness in the us adult population is 0.8% and ranges from about 3/10000 to 15/10000 in children. data from world health organization show that about 500,000 children become blind each year. the annual cost of blindness to the federal government is $4 billion and the cost of a lifetime of support and unpaid taxes for a blind person is about $1 million. there is a need to restore vision for blind patients. research on vision restoration develops fast. there are multiple types of approaches toward producing useful artificial vision. one of them directly sends images from a video camera to the visual cortex via an electrode array that is intracranially placed on the visual cortex of blind patients. another one surgically places an electrode array beneath the retina for patients whose optic nerves are still healthy. both of them require major surgery and have high risks, and neither is available for routine clinical application. the one that is non-invasive and easy to use is called the brainport® system. the brainport® system is manufactured by wicab, inc. it is commercially available and affordable to any consumer. this system is a novel, bionic, non-invasive, vision bypass system that conveys environment images from a spectacle-frame-mounted video-camera to the brain via an electro-tactile tongue array. the electro-tactile stimulation delivered by the tongue-array placed on the tongue allows users to interpret the images of objects in their camera's visual field.

Eligibility criteria:
inclusion criteria: * less than 25 years of age and be able to cooperate for full study protocol * have a clinical diagnosis of blindness (light perception or worse), or 20/20 vision corrected or otherwise. * have completed a complete ophthalmic evaluation. * patients recruited must be able to undergo the training to use the brainport® system. * sign informed consent (family) or assent (patient). exclusion criteria: * have any neurologic disease, developmental delay, congenital genetic syndromes, congenital organ malformation, malformation syndromes or metabolic disease. * be on any medications known to affect the visual system
breath volatile organic compounds patterns of lung transplant patients with chronic lung allograft dysfunction

Conditions: Chronic Lung Allograft Dysfunction (CLAD)

Summary: it's the aim of this study to clarify, whether the non-invasive assessment of breath can serve as a novel clinical tool to assist in the diagnosis of clad. if different stages of bos can be discriminated by the level of certain vocs than there would also be a potential to actually predict the development at an early stage and would enable an earlier intervention.


Eligibility criteria:
inclusion criteria: * outpatient bilateral lung transplant recipients including combined transplants exclusion criteria: * active smoking oxygen therapy infection with multi or pan-resistant bacteria
study hza106827: efficacy/safety study of fluticasone furoate/vilanterol (gw642444) in adult and adolescent asthmatics

Conditions: Asthma

Summary: the purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (gw642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.


Eligibility criteria:
inclusion criteria: * outpatients at least 12 years of age * male and female; female subjects of childbearing potential must be willing to use birth control * pre-bronchodilator fev1 of 40-90% predicted normal * reversibility fev1 of at least 12% and 200ml * current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit exclusion criteria: * history of life-threatening asthma during last 10 years * respiratory infection or oral candidiasis * asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment * uncontrolled disease or clinical abnormality * allergies to study drugs or the excipients * taking another investigational medication or prohibited medication * night shift workers * current smokers or subjects with a smoking history of at least 10 pack years

Keywords: gw642444 vilanterol asthma fluticasone furoate
beta-blocker before extubation

Conditions: Myocardial Ischemia

Summary: silent myocardial ischemia is known to occur in the general medical intensive care unit population immediately following tracheal extubation. we believe these patients are at risk for primary cardiac events in the 4 hours immediately following extubation. metoprolol is a selective beta-1 antagonist, with little to no beta-2 activity at low and moderate doses. the cardioprotective effects of beta blockade have been well documented in randomized controlled trials. in patients undergoing extubation, prophylactic use of intravenous metoprolol may reduce post-extubation ischemia events as well as precursors of cardiogenic pulmonary edema (atrial and ventricular wall tension). our primary hypothesis is that prophylactic metoprolol (titrated to reduce resting heart rate by at least 10%) prior to tracheal extubation will reduce the rate of ischemia as judged by st segment analysis.


Eligibility criteria:
inclusion criteria: * adult medical or cardiac intensive care unit patients on mechanical ventilation who have known coronary artery disease or have at least 2 of the following risk factors for coronary artery disease: * cigarette smoking * hypertension (bp 140/90 or antihypertensive medication) * low hdl-cholesterol (hdl-c) (\<40 mg/dl \[1.03 mmol/l\]) * family history of premature chd (in male first degree relatives \<55 years, in female first degree relative \<65 years) * age (men 45 years, women 55 years) * diabetes mellitus * symptomatic carotid artery disease * peripheral arterial disease * abdominal aortic aneurysm exclusion criteria: * arterial hypotension, defined as mean arterial pressure \< 60 mmhg or requiring any intravenous vasoactive medication. * the presence of known reactive airway disease. * resting heart rate of \<60 in the period prior to tracheal extubation.. * the presence of decompensated congestive heart failure, defined as requiring continuous infusion of an inotropic agent. * known hypersensitivity to beta-blockers or any other contraindication to their use. * subjects younger than 18 years of age. * inability to obtain consent from the subject or the subjects authorized representative. * pregnancy * digoxin therapy * current therapy with a beta-blocker

Keywords: extubation
hypertonic saline enhances the field of view of clinicians and ease of procedures

Conditions: Nasopharyngeal Diseases

Summary: transnasal flexible pharyngolaryngoscopy (npl) is one of the most common and fundamental evaluation procedures in otolaryngologist's practice, performed in both outpatient and ward settings.in the studies the desired properties for an effective topical agent to be used in patients undergoing npl. to date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain. however, to date, no studies have been performed in which intranasal hypertonic saline was used prior to nasal endoscopy.

npl is a technique that has been used for more than 100 years and increases brightness, magnification and the ability to take still and video images (3). npl is a simple, safe, cost-effective, and generally well-tolerated procedure. however, a portion of patients may refuse to allow the procedure to be repeated as they find it uncomfortable, intolerable, or painful.to date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain and increase the field of view and to reduce the duration of examination and unpleasant sensations for the patient on npl procedures.this randomised control trial was undertaken to compare the application of nasal hypertonic sea water (3.5%) with nasal lidocaine 10%, topical nasal decongestant xylometazoline 0.1% (otrivinetm) and nasal isotonic serum physiologic as placebo group in relation to how they effectively improve the adequacy of the examination and if they reduce pain and discomfort associated with endoscopic nasal examination.

Eligibility criteria:
inclusion criteria: * subjects who undergone diagnostic nasal endoscopy between 2015- 2017 exclusion criteria: * had experienced nasal endoscopy before * pregnant * allergic to either xylometazoline or lidocaine * asthma * cardiovascular disease * rhinitis * severe septal deviation

Keywords: hypertonic saline solutions lidocaine oxymetazoline isotonic saline discomfort
diabetic foot ulcer (dfu) rapid pathogen identification

Conditions: Diabetic Foot Ulcer; Diabetes Mellitus; Wound

Summary: the purpose of this study is to evaluate the role of rapid diagnosis of pathogens in treatment of infection and wound healing in diabetic foot ulcers. this research is studying the use of a new device of people to learn if metagenomic next generation sequencing (mngs) techniques technology is a feasible tool that can be used to direct targeted antibiotic therapy in infected diabetic foot ulcers. participant's tissue will be randomized to usual care tissue collection and cultures (standard of care) or usual care tissue collection and cultures (standard of care) plus metagenomics next generation sequencing (mngs). the participant's will not be randomized to any treatment (i.e. antibiotic therapy).

participants will have tissue taken per standard of care at the baseline visit. in addition, participants will complete of a comprehensive medical history questionnaire, michigan neuropathy questionnaires, and have assessments of the foot ulcer or wound. the study team will follow participants for approximately 12 weeks. initial antibiotic therapy to treat diabetic foot ulcer infections are determined by participants treating provider and are based on clinical characteristics, drug allergies or sensitivities, and suspected causative pathogen (i.e., bacteria). in this study, the identification of pathogens using mngs will be given to the treating physician and may result in additional or different antibiotics. the decision for antibiotic prescription(s) to treat the diabetic foot ulcer infection will be made by treating providers. the antibiotic plan will be updated according to final culture results (usually 4-6 days following culture of tissue). for those participants randomized to the mngs cohort, the results (usually 24-36 hours following culture of tissue) will be shared with the treating physician. the treating physician may provide additional or different treatment than initially prescribed.

Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus * have an infected dfu with a surface area ≥0.5 square centimeter (cm2) o dfu infection status will be clinically recorded at time of enrollment according to infectious disease society of america (idsa): mild, moderate, or severe infection * have a hemoglobin a1c\[hba1c\] of 12% or less as measured within the last 6 months, * stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: * pregnant or lactating * uncontrolled blood glucose as demonstrated by a hba1c of greater than 12% * bilateral wound or ulcer * current infection of coronavirus disease 2019 (covid19) * unable to provide informed consent or are unwilling to participate

Keywords: wound infection wound assessments wound's microbiome next generation sequencing