Kornimate/medical-research-clean huggingface dataset:
spyglass in preoperative diagnostics of presumed main duct ipmns: efficacy and novel insights on complications

Conditions: Intraductal Papillary Mucinous Neoplasm

Summary: distinguishing intraductal papillary mucinous neoplasms (ipmns) from other pancreatic cystic lesions is essential as ipmns bear risk of becoming malignant. differentiating the main pancreatic duct involving ipmns (md-ipmns) with imaging can be difficult. single-operator peroral pancreatoscopy (sopp) has shown to be a promising method offering additional information on suspected lesions in the main pancreatic duct (md). we aimed to establish the role of sopp in preoperative diagnostics of presumed md-ipmns. a secondary objective was to identify factors that contribute to sopp-related complications.

in this multicenter, partly prospective, but mostly retrospective cohort study, 101 sopps were performed due to presumed md-ipmns in three centers. as a key outcome, the rate of how often visual appearance of md, and/or md flushing liquid samples and biopsies taken during sopp affected further clinical care, was determined. secondly, post-sopp complications according to cotton consensus criteria, diameter of md, use of prophylactic nonsteroidal anti-inflammatory drugs (nsaids) and pancreatic stents, duration of sopp and timing of pancreatic sphincterotomy (ps) were documented.

Eligibility criteria:
inclusion criteria: * medical imaging showing suspision of ipmn,. * medical imaging showing dilatation of the pancreatic duct exclusion criteria: - malignancy confirmed by previous examinations

Keywords: spyglass pancreatoscopy single-operator pancreatoscopy post-ercp pancreatitis
clinical trial to evaluate the safety and efficacy of scai-001 compared to restasis

Conditions: Dry Eye Syndromes

Summary: this study is planned to evaluate the efficacy and safety of scai-001 eye drops(cyclosporine 0.01%, 0.02%) compared to restasis(cyclosporine 0.05%) in patients with dry eye disease.


Eligibility criteria:
inclusion criteria: 1. male and female who over 19 years old 2. those who have dry eye symptoms (dryness, grittiness, soreness, irritation, watering, etc.) 3. those who meet below criteria at least one of two eyes; * those who have over than score 2 in corneal staining test-oxford grading * tear secretion test without anesthesia(schirmer test) result would be under 10mm/5min (if the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye) * tbut(tear film break-up time) test result should be under 10sec. 4. the corrected visual acuity is 0.2 or more. exclusion criteria: 1. those who have clinically significant eye disease not related to dry eye syndrome 2. those who are in medication of systemic steroid or immunosuppressant 90days before screening visit 3. those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period 4. those who have medical history with intraocular surgery 12months before screening visit 5. those who have diagnosed with glaucoma or have an intraocular pressure over than 21mmhg at least in one of the eyes 6. those who have medicated cyclosporine eye-drops 6weeks before screening visit 7. those who have underwent any eye correction surgery such as lasik(laser-assistant in situ keratomileusis) 12 months before screening visit 8. those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit 9. those who have received other investigational drugs/devices 30 days before screening visit 10. those who are inappropriate for participating in this study according to investigator's judgement

Keywords: dry eye cyclosporine
antidepressant drug exposure and risk of suicide attempt resulting in medical intervention in us adults

Conditions: Depression; Suicide

Summary: the primary objective of the study is to estimate the incidence of suicide attempts resulting in a medical encounter or hospitalization in seven propensity matched cohorts of subjects: patients treated with duloxetine for depression, patients treated with one of three other antidepressants or antidepressant classes (venlafaxine, ssris, or tcas) for depression, patients treated with multiple antidepressants for depression (either concurrently or consecutively), depressed patients with no pharmacologic treatment, and a non-depressed general population sample.


Eligibility criteria:
inclusion criteria: * age 18 years or older at index date * have at least 6 months of continuous enrollment data prior to index date. * have complete medical, facility, and pharmacy records (the latter of which will include complete quantity and days supplied information). exclusion criteria: * none
solution-focused brief therapy for support of psychological distress in adolescent and young adult cancer survivors

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial evaluates the how well a virtually delivered solution-focused brief therapy (sfbt-c) works to decrease adolescent and young adult cancer survivors' psychological distress in comparison to enhanced treatment-as-usual care. cancer and its treatment can have immediate and long-term impacts on adolescent and young adult cancer survivor's lives, including education and employment, financial stability, sexual health, and social, romantic, and family relationships. consequently, many adolescent and young adult cancer survivors report psychological distress, often manifesting as depression and anxiety, and may benefit from psychotherapy to improve their engagement with medical treatment and overall quality of life. sfbt-c is a theory-driven and brief hope-based psychotherapy designed for the unique psychosocial needs facing adolescent and young adult cancer survivors. undergoing sfbt-c may work better than treatment-as-usual care for the support of psychological distress in adolescent and young adult cancer survivors.


Eligibility criteria:
inclusion criteria: * 15 - 39 years old * diagnosed with cancer * receiving active cancer care (6 weeks post initial diagnosis to control for emotional responses to normative stressors) or within 5 years of post-treatment survivorship * experiencing psychological distress (i.e., a t-score \>= 57 on the brief symptom inventory - 18 items \[bsi-18\]) * fluent in english exclusion criteria: * end-of-life care * \> 5 years into the post-treatment survivorship * major physical challenges (e.g., hearing loss, developmental delay) * acute mental health conditions (e.g., active psychosis, suicide risk) * receiving or newly initiated psychotherapy for psychological distress during the study period
a study of acalabrutinib in combination with rituximab + (bendamustine or venetoclax) in subjects with mcl

Conditions: Mantle Cell Lymphoma (MCL)

Summary: a phase 1b, multicenter, open-label study of acalabrutinib in combination with bendamustine and rituximab (br) or venetoclax and rituximab (vr) in subjects with mantle cell lymphoma

this is a multicenter, open-label phase 1b study to assess the safety and efficacy of acalabrutinib when administered concomitantly with bendamustine and rituximab in subjects with treatment naive or relapse refractory mantle cell lymphoma (part 1), or when administered concomitantly with venetoclax and rituximab in subjects with treatment naive mantle cell lymphoma (part 2).

Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age. * pathologically confirmed mcl. * eastern cooperative oncology group (ecog) performance status of ≤ 2. * agreement to use highly effective forms of contraception during the study and for 2 days after the last dose of acalabrutinib, 30 days after the last dose of venetoclax, or 12 months after the last dose of rituximab, whichever is longest. * treatment naive mcl patients requiring treatment with no exposure to prior therapies. exclusion criteria: * significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification.exception: subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study * malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass * uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug * breastfeeding or pregnant * concurrent participation in another therapeutic clinical trial.

Keywords: bruton tyrosine kinase inhibitor btk mantle cell lymphoma mcl acalabrutinib ace-ly-106
bacterial control in partial thickness burns using silver-containing wound dressings

Conditions: Burn Wounds - Partial Thickness (2nd Degree)

Summary: this study is to compare the treatment with two different silver-containing wound dressings: aquacel ag hydrofiber versus acticoat burn dressing.


Eligibility criteria:
inclusion criteria: * burn wounds with flux values, measured by laser doppler imaging, corresponding with expected healing time between 7 and 21 days, flux values between 200 and 1000 (red-pink or pink-yellow-green colour) * wounds treated with a hydrocolloid paste prior to ldi * possibility to follow the complete treatment schedule until wound healing and participation on complete follow-up schedule * informed consent * partial thickness burns with tbse \< 40% exclusion criteria: * mean flux values \ 1000 * tbsa \> 40% * impossibility to debride necrotic skin prior to ldi measurement * wounds treated with any topical ointments or dressings other than hydrocolloid prior to ldi * not following the complete treatment schedule or missing some evaluations during the follow-up period * patient has any condition that seriously compromises the patient's ability to complete the study * patient has participated in another study using an investigational drug within the previous 30 days * patient has one or more medical condition(s)that in the opinion of the investigator would make the patient an inappropriate candidate for this study * the plastic surgeon decides that surgery is necessary due to unusual circumstances * patient wish to decline from the study * no informed consent * full thickness burns

Keywords: burn wounds - silver dressings - bacterial control
fmri study of early brain injury in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is a chronic autoimmune disease involving multiple organs and systems. the central nervous system is one of the most commonly involved parts, and the involvement of the nervous system is called neuropsychiatric lupus, which is one of the most common complications of sle and the main cause of death. cognitive impairment and emotional disorders are the most common neuropsychiatric symptoms, with a prevalence of up to 80%. studies have shown that the prevalence of npsle is between 37% and 95%. compared with sle patients, the mortality rate increases by three times. early diagnosis and treatment play an important role in improving the quality of life of patients. fmri has the advantages of non-invasive, in vivo and high repeatability, and can detect the brain function changes of patients early before the structural changes. this study uses fmr to compare the differences in brain function changes between sle patients and healthy controls, explore the neuroimaging mechanism of brain injury, and provide reference for the early clinical intervene.

the fmri images of 40 sle patients with neuropsychiatric symptoms, 40 sle patients without neuropsychiatric symptoms and 40 healthy controls matched by sex, age and education level were collected. fmri was selected as an evaluation method to compare the differences in brain functional changes among the three groups, and to explore the specific brain regions in the imaging of early brain injury in sle. neurocognitive assessment was performed on all subjects, clinical data and laboratory serum markers of sle patients were collected, and the correlation between sle patients and specific brain regions was analyzed, and multiple regression models were constructed to provide imaging references for early clinical diagnosis and intervention in the process of npsle.

Eligibility criteria:
inclusion criteria: 1. age and gender matched the case group 2. right-handed 3. no cerebrovascular, neurological or mental diseases 4. can cooperate with mri and neuropsychiatric examination exclusion criteria: 1. patients with serious diseases of other systems 2. patients with diseases of central nervous system 3. other rheumatic immune system diseases 4. neuropsychiatric history 5. smokers, drug users or alcoholics 6. contraindicated mri
association of amino acid prevalence and chronic brain injury

Conditions: Chronic Traumatic Brain Injury

Summary: years after a suffering a brain injury, individuals remain in a physically and cognitively impaired state. the investigators believe that the concentrations of amino acids in the blood are chronically altered and yield negative effects on the individuals health. preliminary data has shown significantly lower concentrations of amino acids in serum samples from the tbi population, these diminished levels of amino acids may be due to changes in the microbiome. understanding these changes will help guide rehabilitative services for this population. individuals with a chronic brain injury will donate samples of blood, oral tissue, and fecal matter to be compared to that of non-injured individuals. genetic information from the hosts will be striped and discarded; participant's genetic information will not be retained. to better understand changes in the microbiome, any history of antibiotics and probiotics will be assessed.

the purpose of this study is to evaluate the levels of amino acids in adult individuals with chronic (\> 2 years) traumatic brain injury (tbi) when compared to a non-brain injured cohort population. preliminary data from an assay of amino acids in individuals with chronic tbi compared to an assay of individuals without a tbi revealed significantly lower concentrations of amino acids within the tbi group. the composition and structure of the oral and fecal microbiome will be determined by 16s rdna sequencing. taxonomic and community structure profiles will be treated as outcome variables and modeled together with the participant's plasma amino acid concentration, years post-injury, age, sex and other variables to determine correlations. these correlations may improve our understanding of the diminished amino acid metabolism within the chronic tbi population. the endpoint will identify the microbiome structure and composition by 16s rrna gene sequencing within the tbi and healthy participants and to assess the participant's amino acid concentrations and other participant demographics and phenotypic characteristics (years post-injury, age, sex). this comparison may improve our understanding of the diminished amino acid metabolism within the chronic tbi population.

Eligibility criteria:
inclusion criteria: * willing to donate 10 ml of blood * willing to donate oral tissue sample * willing to donate fecal sample exclusion criteria: * (for brain injured group) have a chronic (greater than two years) traumatic brain injury. * unable to provide to give voluntary informed consent

Keywords: chronic brain injury traumatic brain injury (tbi) amino acids microbiome
set-to-meet; pilot testing of a nurse-led intervention

Conditions: Critical Illness

Summary: while interdisciplinary family meetings are evidence-based and part of usual care, this study seeks to test a novel set of implementation strategies (the set-to-meet intervention) to improve adherence to best practice guidelines for interdisciplinary family meetings. set stands for screen-engage-track; set-to meet is a nurse-led, team based intervention to ensure routine interdisciplinary family meetings are held on behalf of incapacitated, critically-ill patients in icus. this study is a feasibility and acceptability pilot test of the intervention.

the intervention components are: a protocol for interdisciplinary family meetings that is tailored to the individual icu unit and steps in the set-to-meet process: 1.) screening of patients on admission to determine if patient meets criteria for a family meeting; 2.) proactively engaging family members to inform them about the unit's protocol for family meetings and to find out who from the family might attend the meeting; and tracking the progress of setting up the meeting (identifying the patient during icu team rounds as a patient meeting criteria for a family meeting; discussing setting up the meeting with the icu team; scheduling the meeting and communicating details to attendees.) implementation of the intervention includes: 1.) working with the site icu physician and nursing leadership to tailor the set-to-meet protocol and tracking tool for family meetings, ensuring they are customized for the unit workflow and staffing model, and 2.) providing on-line training and 2 weeks of on-site coaching to icu nursing staff, care management/social work staff, and intensivists (md and app) in the use of the tailored protocol and tracking tool. feasibility and acceptability will be assessed by percentage of staff completing training, adherence to elements of the intervention, and number of patients meeting enrollment criteria. acceptability will be assessed via focus groups and a survey testing satisfaction with the intervention.

Eligibility criteria:
inclusion criteria: * patients: individuals ≥18 year of age, admitted to the icu for intensive care services at one of the 3 pilot sites during the pilot testing phase. * pilot site clinicians: nurses, care managers, social workers, and physicians who are employed/provide services in the pilot site. exclusion criteria: * patient exclusion criteria : those individuals \< 18 years of age, incarcerated, or admitted for reasons other than receipt of intensive care services (e.g. boarders). * pilot site clinicians exclusion criteria: none

Keywords: intensive care unit serious illness communication clinician-family communication family support
health literacy in adults with congenital heart disease

Conditions: Congenital Heart Disease

Summary: currently, both oral and written health education make certain assumptions about the health literacy of patients and their parents. the prevalence of health literacy issues is unknown in the adult congenital heart disease (chd) population. having a better understanding of a patient's and/or their parents' health literacy will help us develop appropriate education and teaching tools to meet the patient's and their parents' needs.

when providers speak with patients regarding their congenital heart disease, they currently have no assessment of the patient's basic health literacy. if providers are aware of the level of their patients' health literacy, they will be better equipped to provide care on the level the patient best understands.

Eligibility criteria:
inclusion criteria: * males or females 18 years of age and older with congenital heart disease. exclusion criteria: * developmentally delayed subjects. * any subject not meeting inclusion criteria.
gene therapy for wet amd

Conditions: Neovascular Age-related Macular Degeneration

Summary: ft-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (namd). neovascular amd is the main cause of blindness among elderly individuals. the available therapies for treating namd require life-long intravitreal (ivt) injections every 4-12 weeks to maintain efficacy. administration of ft-003 has the potential to treat namd by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. ft-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with namd receiving anti-vegf therapy in clinical practice.


Eligibility criteria:
inclusion criteria: * subjects that are willing and able to follow study procedures; * female or male patients ≥45 years old at the time of signing the icf; * clinically diagnosed with namd; * presence of active cnv * the best corrected visual acuity (bcva) of the studied eye is ≤ 53 letters; exclusion criteria: • presence of any other intraocular diseases other than namd in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.
assessment of the cognitive load of the landed combatant in virtual reality.

Conditions: Fatigue

Summary: to support the landed soldier during operational missions in hostile environment, equipment must be designed to enable soldiers to cope with strong visual, auditory and informational demands. technological solutions proposed by manufacturers are embodied in increasingly sophisticated systems. these systems take too little account of the characteristics of the perceptive and cognitive skills of human beings in an action situation. cognitive load results from the interaction between, on the one hand, the characteristics of the task and the constraints it imposes, and on the other hand, the resources available to the individual, in terms of skills, motivation, physiological state and social support. the phenomenon of cognitive overload occurs when the individual no longer has sufficient resources to meet the demands of the task, which leads to a deterioration in his performance which, in high-risk situations, jeopardizes his safety. tasks are treated differently depending on their level of difficulty. we will base ourselves on rasmussen's srk (skill rule knowledge) model, which describes three levels of information processing: level s refers to the (automatic) processing of sensory-motor and cognitive skills, level r refers to the execution of rules and procedures embedded in mental models, and level k refers to the mental activities of elaborating procedures, based on high-level cognitive mechanisms, such as anticipation, evaluation or planning. multitasking situations are therefore generally composed of tasks of various levels of difficulty which lead to a higher or lower cost of cognitive control. thus, this study is aimed at identifying variations in the subjective level of cognitive load of landed combatants (group leaders) as a function of the level of difficulty of primary tasks.


Eligibility criteria:
inclusion criteria: * to be a soldier in an infantry regiment, * to be a group leader. exclusion criteria: * to be in a situation of motor disability, * to have a cardiac pathology, * to have a visual pathology not corrected by glasses or contact lenses, * to have a hearing impairment, * to have a psychiatric disorder; a progressive neurological or organic pathology requiring drug treatment, * to take psychotropic drugs, * to take more than 28 units of alcohol per week, * to be epileptic.

Keywords: cognitive overload