Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of winged biliary stent patency in patients with benign biliary obstruction

Conditions: Biliary Stricture

Summary: evaluation of ercp with placement of a winged plastic biliary stent without a lumen for management of benign biliary strictures.

ercp with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. however, stent obstruction is a major limitation of this approach. studies have shown that the conventional tubular type polyethylene stents (cs) with side holes accumulate significant sludge and their mean patency is approximately 90 days. thus patients requiring longer term stenting need to undergo stent exchanges every 2-3 months. recently, a stent with a star-shaped cross-section has been developed for biliary applications. this fda approved biliary wing stent (ws) (viaduct™) is a novel plastic biliary stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent. the stent which is star shaped in cross section, channels fluid along its winged perimeter. it has been proposed that the winged stent design with a lack of central lumen obviates the risk of luminal occlusion and that the risk of occlusion, given the presence of multiple external drainage channels, is smaller. longer term biliary drainage without the need for stent exchange should therefore be possible with these stents. the primary aim of this study is to prospectively evaluate the patency rate of the winged stent in up to 90 days for patients with benign biliary obstruction.

Eligibility criteria:
inclusion criteria: 1. all patients age 18 or older referred for ercp for biliary obstruction from stones or benign strictures that have been confirmed based on clinical, laboratory and imaging findings, with an indication for plastic stent placement. one or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care. 2. expected patient survival of at least 90 days 3. high likelihood of patient follow-up 4. patient is able to give a written informed consent 5. patient is willing and able to comply with the study procedures. exclusion criteria: 1. patients with cholangitis 2. patients with bile leak 3. pregnant patients 4. patients with any contraindication to endoscopic procedure 5. participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit 6. patients with malignant biliary strictures
motor function and activity of daily life in spinal muscular atrophy

Conditions: Spinal Muscular Atrophy

Summary: this study will incorporate patients/ caregivers' perspectives to investigate the performance in daily activities of individuals with sma and how it relates to their motor function abilities.

spinal muscular atrophy (sma) is an autosomal recessive neuromuscular disease that causes progressive muscle weakness and atrophy and eventually leads to loss of function. despite recent advances in disease-modifying treatments, sma can still significantly impact an individual's functioning in daily living and quality of life. this study will incorporate patients/ caregivers' perspectives to investigate the performance in daily activities of individuals with sma and how it relates to their motor function abilities.

Eligibility criteria:
inclusion criteria: * having a diagnosis of sma with genetics confirmed as 5q sma. * above 3 years of age (capable of performing motor assessments). exclusion criteria: * having severe respiratory and other medical conditions precluding safe participation in standardized motor function tests. * having any orthopedic surgery during the past 6 months. * women who are pregnant.
pain in long covid-19: the role of sleep

Conditions: Long COVID

Summary: pain is among the most frequently reported symptoms in long covid, along with sleep disturbances, fatigue, and cognitive impairments. sleep plays a critical role in maintaining a pain-free state. the goal of this study is to characterize the type and severity of pain in long covid, to characterize sleep and sleep disturbances in long covid, and to understand the role of sleep in the development and persistence of pain symptoms in long covid.


Eligibility criteria:
inclusion criteria: * females and males \>18 years * confirmed history of sars-cov-2 infection exclusion criteria * history of chronic pain prior to sars-cov-2 infection * raynaud syndrome * pregnant/nursing
oxytocin modulates eye gaze behavior during social processing

Conditions: Healthy

Summary: the main aim of the study is to examine whether the effects of intranasal oxytocin on eye-gaze behavior towards social stimuli are modulated via individual differences in trait autism

in this double-blind, within subject, placebo controlled design a total of n = 40 healthy male subjects will receive either 24 iu of oxytocin or placebo (interval between administration \> two weeks). 45 minutes after treatment subjects will undergo a total of 7 eye-tracking paradigms examining eye-gaze behavior during social processing: (1) dynamic social-nonsocial visual preference task during which movies of dynamic geometric images (dgi) and dynamic social images (dsi) will be presented; (2) non-biological versus biological motion task; (3) social attention and motivation of sharing enjoyment; (4) preference for emotional faces versus schematic faces (emoticons); (5) shared social attention - shared gaze direction with an actor shifting his attention to different objects; (6) preferred visual scanning of face regions in emotional faces; and, (7) eye gaze in response to empathy eliciting visual stimuli. autistic and associated traits will be assessed using the autism spectrum quotient (asq), social responsibilities scale (srs) and the interpersonal reactivity index (iri). within-subject differences in the effects of oxytocin on social eye gazing behaviour will be related to individual differences in autistic traits.

Eligibility criteria:
inclusion criteria: * healthy subjects without any past or present psychiatric or neurological disorders exclusion criteria: * history of brain injury * visual impairments * use of medication * contraindications for oxytocin administration

Keywords: oxytocin eye tracking autistic trait
safety and efficacy of scd in aki or ards patients associated with covid-19 infections

Conditions: AKI; ARDS; COVID

Summary: selective cytopheretic device (scd) treatments will improve survival in patients testing positive for covid-19 infection diagnosed with acute kidney injury (aki) or ards.


Eligibility criteria:
inclusion criteria: * informed consent obtained * positive covid-19 test * must be receiving medical care in an intensive care nursing situation * non-pregnant females * intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours. * platelet count \>30,000/mm3 at screening * clinical diagnosis of aki requiring crrt or ards exclusion criteria: * cardiovascular instability that precludes initiation of continuous renal replacement therapy (crrt). * irreversible brain damage based on available historical and clinical information. * presence of any solid organ transplant at any time. * patients with stem cell transplant in the previous 100 days or who have not engrafted. * acute or chronic use of circulatory support device other than ecmo such as lvads, rvads, bivads. * metastatic malignancy which is actively being treated or may be treated with chemotherapy or radiation during the subsequent three month period after study treatment. * chronic immunosuppression defined as \>20 mg prednisone qd alone without other immunosuppressant medications (ie (cyclophosphamide, azathioprine, methotrexate, rituximab, mycophenolate, cyclosporine). * patient is moribund or chronically debilitated for whom full supportive care is not indicated. * concurrent enrollment in another interventional clinical trial. patients enrolled in observational studies (no test device or drug used) are allowed to participate. * any reason the investigator deems exclusionary.
lung function in post-covid-19 nursing home residents

Conditions: Post-COVID-19 Syndrome

Summary: the coronavirus disease 2019 (covid-19) took a toll in institutionalised older adults, who represent a vulnerable population in european countries. the aim of this study is to identify the predictive factors that worsens lung function in post-covid nursing home (nh) residents. this is a multicenter case-control study in nursing homes of osona (catalonia), where individuals with worsened (cases) and normal (controls) lung function will be studied. the inclusion criteria are: female and male from 65 to 95 years old, preserved cognitive capacity and positive diagnosis of covid-19 at least 3 months prior. we will assess sociodemographic variables, lung function \[spirometry\], fatigue \[chalder fatigue scale\], frailty \[clinical frailty scale\], and activities of daily living (adl) \[modified barthel index\].


Eligibility criteria:
inclusion criteria: * male and female * preserved cognitive function * previous positive diagnosis of covid-19 at a minimum of 3 months to the day of data collection * individuals living permanently in a nursing home exclusion criteria: * individuals in coma or palliative care * any contraindication to perform spirometry (severe hypertension, myocardial infarction in the past week, non compensated heart failure, etc).
effect of health diary on self-management in adolescent patients with fixed orthodontic appliance

Conditions: Oral Hygiene; Self-Management

Summary: this study aims to use two-arm randomized clinical trials to evaluate the effectiveness of the health diary in helping adolescents wearing fixed orthodontic appliances improve their oral hygiene status, self-management skills, oral health-related quality of life, self-efficacy, intention，number of breakages, and on-time and return visit status.


Eligibility criteria:
inclusion criteria: * patients with malocclusion eligible for fixed appliance orthodontic treatment; * the age of patients ranged from 12 to 18 years; * the patients received orthodontic treatment for the first time; * the patient was alert and had no cognitive or psychiatric impairment; * the patient was able to read and fill out the questionnaires, and had good listening, speaking and understanding skills in chinese. exclusion criteria: * the patient's disease was diagnosed as jaw deformity associated with other diseases. malocclusion secondary to trauma, tumor, cleft lip and palate; * patients treated with orthodontic-orthognathic surgery; * the patient currently participating in other oral related intervention studies.

Keywords: malocclusion fixed orthodontic treatment adolescent self-management self-efficacy health diary oral health-related quality of life oral hygiene
mindfulness and acceptance-based treatments for social anxiety: defusion app

Conditions: Anxiety; Shyness

Summary: this study evaluates a self-help app in the treatment of shyness and social anxiety in adults. all participants will be assigned to the treatment group. it is expected that using this app will result in a reduction in social anxiety.

over 2 million canadians have suffered from social anxiety disorder (sad) at some point in their lives. this disorder is characterized by a strong fear of negative evaluation in social situations and is associated with significant impairment in social interactions, educational/occupational achievement, and life satisfaction. despite the fact that efficacious treatments have been developed and evaluated, both treatment effectiveness and treatment seeking behaviour remain below optimal levels. combined with the many barriers to treatment (i.e., cost, stigma, access), researchers are investigating self-help modalities as an alternative to conventional psychotherapy. the defusion app is based on content from fleming \& kocovski's (2013) self-help book "the mindfulness \& acceptance workbook for social anxiety \& shyness." specifically, the app teaches users about the tendency of socially anxious individuals to fuse with their anxious thoughts (i.e., cognitive fusion), and strategies to reduce it. in this experimental research study, a smartphone app designed to help with social anxiety and shyness will be evaluated for both effectiveness and frequency of use. the objectives will be to determine whether participants use the app, and whether use of the app is associated with a reduction in social anxiety. preliminary evidence has indicated that smartphone apps for mental health are associated with promising results. it is expected that the use of the app in the present research will be associated with reductions in social anxiety symptom severity and a greater use of cognitive defusion strategies. the participants will be a community sample of individuals interested in seeking help with social anxiety and shyness as recruited by the use of posters around the wilfrid laurier university campus and in the community, as well as online.

Eligibility criteria:
inclusion criteria: * must be seeking help for shyness/social anxiety * must own a smartphone exclusion criteria: * none
lipoic acid for secondary progressive multiple sclerosis (ms)

Conditions: Multiple Sclerosis, Chronic Progressive

Summary: the purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.

there are no approved medications that are neuroprotective or able to slow disability accumulation in secondary progressive multiple sclerosis (spms). this two-year study will determine if daily oral intake of lipoic acid, a natural supplement, will prove superior to placebo in reducing injury to the brain and reducing disability progression in spms. neuroprotection will be measured by the extent of brain volume loss seen on mri, and disability will be measured by neurological status and quality of life.

Eligibility criteria:
inclusion criteria: * diagnosis of spms * age 40-70 years * able to understand english and able to give informed consent exclusion criteria: * unable to undergo mri testing * for ambulatory subjects only, a self-reported medical or neurological condition other than ms that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease) * for ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.) * pregnant or breast-feeding. * current major disease or disorder other than ms (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures * natalizumab, mitoxantrone, azathioprine taken in the last 12 months * other immunosuppressants or chemotherapies taken in the last 12 months * scheduled (every 3 months or more frequently) iv steroids used in the last 12 months * iv or oral steroids taken in the past 60 days. * lipoic acid taken in the past 60 days. * subject has insulin-dependent diabetes or is not controlled on oral diabetes medications

Keywords: multiple sclerosis multiple sclerosis, chronic progressive neuroprotective agents magnetic resonance imaging optical coherence tomography gait thioctic acid alpha-lipoic acid
whole body vibration and virtual reailtry on quadriceps strength and activity of daily living in children with burn

Conditions: Whole Body Vibration; Virtual Reality

Summary: burns are injuries that can have both local and systemic effects and are brought on by biological, chemical, electrical, and physical factors. mobility is a significant problem for burn patients in terms of their quality of life since the burn injury affects their capacity to participate in activities of daily living. the immobility of the patient has a major impact on their physical health. the aim of current study was to compare between the effect of virtual reality and whole body vibration as two methods of proprioceptive stimulation on quadriceps strength and activity of daily living in children with burn.

the current study is pre-post experimental study which was carried out from january 2024 to june 2024. a stratified and convenience sampling technique was used to select the study participants taking into consideration the inclusion criteria. forty children with lower limb thermal burn were selected from ahlah misr burn hospital to participate in this study. they were selected according to the following inclusion criteria: a) both sexes were included, b) children with unilateral front thigh thermal burn of deep partial thickness of dermis (second degree) burns, c) their ages ranged from 6 to 12 years, d) they can assume standing position. a child who had one or more of the following criteria was excluded from the study: a) 1st, 3rd and 4th degrees of burn, b) other types of burn rather than thermal, c) neurological or neuromuscular disorders, d) dermatological disorders, e) visual or hearing disorder, f) child with contractures or lower limbs on fixed deformities. subjects who met the previous mentioned criteria were randomly assigned into two study groups of equal numbers study i \& study ii using sealed envelope. study group i were treated by a conventional physical therapy program directed towards improving the condition of the patient function in addition to whole body vibration therapy. study group ii were treated by a wii-fit therapy program in a form of virtual reality treatment program in addition to the same conventional physical therapy program given to patients in the study group i.

Eligibility criteria:
inclusion criteria: 1. both sexes were included 2. children with unilateral front thigh thermal burn of deep partial thickness of dermis (second degree) burns 3. their ages ranged from 6 to 12 years, d) they can assume standing position exclusion criteria: 1. 1st, 3rd and 4th degrees of burn 2. other types of burn rather than thermal 3. neurological or neuromuscular disorders 4. dermatological disorders 5. visual or hearing disorder 6. child with contractures or lower limbs on fixed deformities.

Keywords: burn proprioceptive stimulation whole body vibration virtual reality activity of daily living
radiostereometry in knee arthroplasty

Conditions: Knee Osteoarthritis; Knee Arthropathy; Aseptic Loosening

Summary: the innovative aspect of this research is the possibility of combining the data collected with radiostereometric model based radiostereometry with the data collected through the galeazzi institute registry.this opens the prospect of an earlier identification of patients undergoing prosthetic knee replacement with initial aseptic loosening.


Eligibility criteria:
inclusion criteria: * age more than 18 * patients underwent total knee arthroplasty without controindications for this procedure * patients enrolled in patientsreportedoutcomesmeasures (proms) study exclusion criteria: * age less than 18 * comorbility that make difficult come back for follow-up * patients with allergy at materials used in radiostereometry tecnique * infection * anemia, obesity, osteoporosis * pregnancy
an open label field study of anthim (obiltoxaximab) in subjects exposed to b. anthracis

Conditions: Infection, Bacterial; Anthrax

Summary: this field study is a post-marketing requirement from the fda to evaluate the clinical benefit (course of illness and survival), safety and pharmacokinetics of obiltoxaximab administered to patients as part of their medical care for treatment or prophylaxis of inhalational anthrax infection following exposure to bacillus anthracis (b. anthracis). the protocol can be implemented for any individual who receives obiltoxaximab for a suspected, probable, or confirmed case of inhalational anthrax due to b. anthracis in the united states, including sporadic cases, small incidents and/or a mass event. in case of a small anthrax incident, to the extent possible, the information will be collected prospectively at prespecified time points, except where it would interfere with management of the subject's illness. however, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study are anticipated to be collected retrospectively. both retrospective and prospective data collection are allowed to maximize information collection. this study will collect data on the use of obiltoxaximab in anthrax infected or exposed subjects and the data collected will inform the understanding of the clinical benefit and safety of obiltoxaximab.


Eligibility criteria:
inclusion criteria: * men and women (including pregnant and lactating women) and children of all ages who receive obiltoxaximab as part of their clinical care for anthrax infection and are willing and able to give written informed consent themselves or through legally acceptable representative (for minors, unconscious adults or deceased subjects) to participate in the study exclusion criteria: * there are no exclusion criteria defined for this study

Keywords: anthim® obiltoxaximab anthrax anti-toxin
genetic polymorphisms associated with cigarette smoking and risk of graves' disease

Conditions: Graves' Disease

Summary: cigarette smoking is a well-recognized risk factor of graves' disease and, particularly, graves' ophthalmopathy. hence, germline polymorphisms of detoxification genes and genes belonging to the major dna repair/apoptosis pathways might have an important role in disease susceptibility. in addition, as some of these genes are regulated by thyroid hormones, they could affect the outcome of these patients. our objective was to assess the influence of the gst, cyp and tp53 gene polymorphisms in the risk of graves' disease and its outcome.

although the role of many polymorphisms of genes related to toxins' metabolism has been extensively investigated regarding the susceptibility to thyroid cancer, their influence in thyroid autoimmune diseases risk is still largely unknown. hence, this study was designed to assess the influence of gstt1, gstm1, gstp1, cyp1a1 and 72tp53 polymorphic inheritance on the susceptibility to graves' disease and to its response to the treatment.

Eligibility criteria:
inclusion criteria: * graves' disease patients

Keywords: susceptibility genes environment ophthalmopathy outcome