Kornimate/medical-research-clean huggingface dataset:
an evaluation of innerview™, a web-based tool to support the integration of mental health in the primary care setting

Conditions: Mental Health

Summary: innerview can address some of the challenges of integrating mental health and primary care by accurately and reliably collecting mental health evidence and activities directly from patients, and then organizing and automating that evidence and activity into reports for providers and care teams that support diagnosis, treatment planning and monitoring of the mental health issues within a practice population.

to deliver integrated quality care, innovative strategies are needed to efficiently collect, understand, monitor and manage mental health evidence and its contribution to the primary care office visit. computer applications can provide solutions to providers by helping their processes to be feasible, manageable, and sustainable. we hypothesize that by both providing patients the opportunity to reflect on their physical, emotional and behavioral symptoms and functioning, and giving providers accurate, reliable, current, symptom-based mental health evidence in an accessible organized format prior to the face-to-face visit, innerview will enhance diagnostic and treatment processes from both a patient- and population-based perspective, as well as enhance communication between patient and provider.

Eligibility criteria:
inclusion criteria: * in order to be eligible to participate in this study, a subject must meet all of the following criteria: * provide signed and dated informed consent form * be aged 18 or older * be willing to comply with all study procedures and be available for the duration of the study * be able to read english at an 8th grade level (as determined by physician) * have internet access to email with a computer and/or tablet exclusion criteria: * patients are excluded from study participation if they meet any of the following criteria: * inability to provide consent due to guardianship issues * currently experiencing psychotic symptoms (as determined by physician) * anything that, in the opinion of the investigator, would preclude the subject's full compliance with or completion of the study.

Keywords: mood disorders anxiety disorders eating concerns pain concerns alcohol abuse self harm mental health clinical decision support
study to evaluate the use of palifermin to treat toxic epidermal necrolysis

Conditions: Toxic Epidermal Necrolysis; Stevens-Johnson Syndrome

Summary: to test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in toxic epidermal necrolysis and stevens-johnson syndrome-toxic epidermal necrolysis overlap, diseases in which there is extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal tract, respiratory and genitourinary systems.


Eligibility criteria:
inclusion criteria: * skin biopsy in early disease showing apoptotic keratinocytes in the epidermis and in more advanced disease necrosis of the entire epidermis * epidermal detachment or erythematous to purpuric macules involving more than 10% of body surface area in addition to involvement of the oropharynx; there may be further involvement of other mucosal surfaces, ie. conjunctivae, gastrointestinal tract, respiratory and genitourinary epithelia * age of 18 years old or older * the patient is expected to survive longer than 48 hours exclusion criteria: * skin detachment above 90% of the body surface area * skin detachment has not progressed during the previous 48 hours * a positive serum pregnancy test * age \< 18 years old * known hematologic or solid organ malignancy
a non interventional study to monitor the safety and effectiveness of trajenta (linagliptin, 5 mg, q.d) in korean patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to monitor safety and efficacy of treatment with linagliptin in korean patients with type 2 diabetes mellitus in routine clinical settings.

study design: post marketing study- observational study

Eligibility criteria:
inclusion criteria: patients who have been started on trajenta in accordance with the approved label in korea patients who have signed on the data release consent form exclusion criteria: patients with previous exposure to trajenta and current participation in clinical trials
prevalence of type 2 diabetes mellitus in ethiopian community in israel: an update

Conditions: Diabetes Mellitus

Summary: the prevalence and incidence of diabetes has been reported to vary among populations.immigrants groups as that have undergone significant life-style changes tend to develop diabetes within a short time. the aim of the study is to assess the prevalence of diabetes mellitus in ethiopian population ,15-20 years after immigration in israel.

the study will be conducted in three primary care clinics of the jezreel valley (omer, givat hamore and afula illit). the computerized medical charts of 500 ethiopian adults will be reviewed. the following information will be obtained: age, date of arrival in israel, known history of diabetes, hyperlipidemia, hypertension or other disease, drug therapy, body weight, blood pressure. following laboratory data will be retrieved: blood glucose, hba1c, lipid levels , creatinine and uric acid. the criteria used for the definition of diabetes will be based on the criteria proposed by the american diabetes association .

Eligibility criteria:
inclusion criteria: * male and female ethiopians jews who immigrate in israel in 1991 and were 18 years old or more at immigration. exclusion criteria: * type 1 diabetes mellitus

Keywords: diabetes mellitus, prevalence , ethiopians jews, israel
from active to palliative care: emotional burden and self efficacy in patients and caregivers

Conditions: End of Life

Summary: this study aims to evaluate psychological dimensions in patients and caregivers in the transition phase from active to palliative care.

after being informed about the study, all patient giving written informed consent will enrolled and evaluated at t0 through the general self-efficacy scale (gse), resilience scale (rs-14), toronto alexithymia scale (tas-20), integrated palliative care outcome scale (ipos) and caregiver inventory (cgi).

Eligibility criteria:
inclusion criteria: * age over 18 years old * patients who are not undergoing active treatments (olt) * suitability of the patient for palliative care * ability to express informed consent exclusion criteria: * age \< 18 years * patient not eligible for palliative care (active treatments) * comorbidity factors that make enrollment impossible * inability to give informed consent * psychiatric disorders prior to the current pathology * severe speech impairment
valiant captivia post-market registry

Conditions: Aortic Aneurysm, Thoracic

Summary: the valiant thoracic stent graft has been preloaded on the new captivia delivery system (captivia). this new delivery system was ce marked on september 14th, 2009 and was commercially released in the european union on october 1st, 2009. the valiant thoracic stent graft with the captivia delivery system (valiant captivia) is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. the purpose of the valiant captivia registry is to collect and evaluate mid term clinical performance data of the valiant captivia thoracic stent graft system following ous market approval.

1. use of controls 1. this study is a post-market registry without using a control. all analyses will be descriptive in nature and no statistical comparisons are planned. sample size 2. there is no sample size calculation since this is not a hypothesis driven study; valiant captivia has recruited 100 subjects and will follow these subjects through for approximately 36 months. 2. number of investigation sites and study duration 1. 15 investigation sites in europe and turkey where the valiant captivia thoracic stent graft system is commercially available have enrolled 100 subjects. 2. there will be no minimum nor maximum number of enrolled subjects per investigation site. 3. the sites' compliance with the clinical investigation plan will be assessed on an ongoing basis. in case of serious non-compliance, the sponsor may decide to stop subject enrolment in a site based on the assessment.

Eligibility criteria:
inclusion criteria * age ≥ 18 years or minimum age as required by local regulations * indication for surgical repair of thoracic aortic aneurysms and/or thoracic aortic dissections with an thoracic endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the instructions for use of the valiant captivia thoracic stent graft system * signed consent form ('patient informed consent form' or 'patient data release authorization form') * intention to implant the valiant captivia thoracic stent graft system or having implanted the system within the last 3 months before subject enrollment * willingness and ability to comply with the cip exclusion criteria * high probability of non-adherence to physician's follow-up requirements * participation in concurrent interventional trial which may confound study results * prior implantation of a thoracic stent graft

Keywords: stent graft thoracic aorta dissection aneurysm tevar valiant captivia endovascular
a new ligation using the double-loop clips technique versus traditional techniques in the treatment of large wounds after endoscopic resection

Conditions: Polyps; Closure; Delay

Summary: studies have shown that postoperative inflammation can be relieved by clipping the wound, and can reduce the bleeding rate and perforation rate.scholars at home and abroad have proposed the use of adhesives and circular surgical lines to clamp the wound.in 2019, satoshi abiko and others proposed the use of double-loop clips technology to clamp the wound, and make double-loop clips of appropriate length outside the body.therefore, our study is a prospective randomized controlled study to explore whether the double-loop clips technique is safe and effective for larger wounds in daily clinical work.


Eligibility criteria:
inclusion criteria: * patients with wounds larger than 20mm * patients aged 18 to 75 years old exclusion criteria: * have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or new york heart association class iii-iv. * pregnant or breastfeeding. * allergy or intolerance to any study drug. * patients who have taken anticoagulant drugs (aspirin, clopidogrel, etc.) in the past week but are contraindicated for endoscopic polyp treatment. * other imaging findings suggest patients with advanced cancer. * patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis, and toxic megacolon
recurrent events after percutaneous coronary interventio for acs

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Summary: patients undergoing pci for acs are exposed to a significant ischemic and bleeding risk. the aim of our study is instead to analyze in detail the rates of recurrent events, but also their predictors and impact on outcomes, in a population of unselected real life patients treated with pci for acs discharged on either clopidogrel, prasugrel or ticagrelor who already experienced an adverse event during the first year of follow up.

patients undergoing pci for acs are exposed to a significant ischemic and bleeding risk. the rate, predictors and outcomes of an adverse event in this population has been already investigated. however, to the best of our knowledge, only two papers took specifically in analysis rates of recurrence after a first event; the first is a recently published article by giustino et al; it took in consideration recurrent events in a selected population of patients with st-elevation myocardial infarction (stemi) participating in the horizons-ami trial, discharged on aspirin and clopidogrel, analyzing their incidence in the first year of follow-up. the second is a paper by fanaroff et al which primarily focused on the factors leading to a dapt intensification in patients with recurrent events. the aim of our study is instead to analyze in detail the rates of recurrent events, but also their predictors and impact on outcomes, in a population of unselected real life patients treated with pci for acs discharged on either clopidogrel, prasugrel or ticagrelor who already experienced an adverse event during the first year of follow up.

Eligibility criteria:
inclusion criteria: * inclusion criteria in the present study was the occurrence of an adverse event (bleeding or ischemic) during dapt therapy in the follow-up after pci for acs exclusion criteria: * none
the effect of both ultrasound and fluoroscopy guide erector spinae plane blocks

Conditions: Pain, Chronic; Pain, Postoperative

Summary: since the original publication on the erector spinae plane (esp) block in 2016, the technique of the esp block has evolved significantly in the last few years. current reports suggest that the esp block provides adequate analgesia in thoracic and abdominal sites in a post-surgical and chronic pain patient. however, there were still inconsistencies and unclear spread of local anesthetics in ultrasound guide esp block. this study focusing on the spread of local anesthetic in esp block under ultrasound and fluoroscopy and possible mechanisms of action.

the erector spinae plane (esp) block was first described by forero et al. considering the spread of local anesthetic in the esp block, it can block more extensive spinal nerves. therefore, since the first publication, the esp block has been reported as an effective analgesic for several types of pain and has been used mainly in thoracic surgery. it also used in abdominal surgery, nephrectomy, hernia surgery, and hip surgery, among others. additionally, the esp block used not only acute pain management but also chronic pain management. the spread of local anesthetic in the esp block investigated in several ways, such as computed tomography (ct) imaging of cadavers, fluoroscopy, chest radiography, and patients' ct imaging. these investigations show that local anesthetics in the esp block spread to the upper and lower sides of the interfascial plane between the erector spine muscle and the underlying transverse process. additionally, the local anesthetic spreads beyond the transverse process to reach the costotransverse junctions, after which it permeates the paravertebral space. despite the many publications on esp blocks, there are still inconsistencies and unclear aspects of the technique, such as the spread of local anesthetic and action mechanisms this study focuses on the spread of local anesthetic in esp block under ultrasound and fluoroscopy and possible mechanisms of action.

Eligibility criteria:
inclusion criteria: 1. thirty-five patients in each group of breast tumor surgery and pain intervention procedure patients. 2. age \> 20 exclusion criteria: 1. unable to complete questionnaires. 2. with coagulopathy 3. history of thoracic spine trauma or surgery. 4. allergy to contrast local anesthetics and medium (iohexol)
safety and immunogenicity study of recombinant thrombin (rthrombin) in pediatric participants

Conditions: Blood Loss, Surgical

Summary: the objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rthrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.

the safety, immunogenicity, and efficacy of rthrombin have been evaluated in 5 phase 2 studies, 1 pivotal phase 3 study, and 1 phase 3b study, in surgical indications such as: spinal surgery, major hepatic resection, peripheral arterial bypass surgery, arteriovenous graft formation for hemodialysis access, and burn wound excision. limited data currently exist on the effects of rthrombin exposure in pediatric patients. this phase 4 trial aims to provide additional information on the use of rthrombin in children by evaluating the drug's safety and immunogenicity when administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric burn patients.

Eligibility criteria:
inclusion criteria: * age of newborn through 17 years at time of enrollment * at least 1 skin graft recipient site measuring at least 1% of total body surface area (tbsa) * total initial burn wounds estimated to measure less than 40% of tbsa * bleeding indicating treatment with rthrombin during the surgical procedure * females of child-bearing potential must have a negative urine or serum pregnancy test within 2 days prior to study-drug treatment * informed consent document signed by legal representative (guardian) and approved by an institutional review board/independent ethics committee (irb/iec) * participant has signed an irb/iec-approved pediatric assent document, if applicable exclusion criteria: * gestational age younger than 36 weeks at birth (for infants younger than 2 years) * documented active infection at the graft recipient site (participants with resolved infections at potential graft recipient sites are not excluded) * acute inhalation injury, as defined by bronchoscopic evidence of lower airway injury * currently undergoing autologous skin grafting for ischemic ulcer disease or cutaneous malignancies * presence of antibodies or hypersensitivity to the study drug or any of its components, other thrombin preparations, or coagulation factors * transfusion of whole blood, fresh frozen plasma, cryoprecipitate, or platelets within 24 hours prior to study-drug treatment (packed red blood cell transfusions are allowed) * history of hiv infection or other immunodeficiency syndrome or is taking immunosuppressive or antirejection medications * medical, social, or psychosocial factors that, in the opinion of the investigator, could affect safety or compliance with study procedures * breastfeeding or being breastfed * treatment with any experimental agent within 30 days of study enrollment or treatment
ablelite pediatric device clinical study

Conditions: Muscular Dystrophies

Summary: the primary objective of the ablelite early feasibility study is to evaluate the function of the upper limbs of participants diagnosed with neuromuscular disorders as children, with and without use of the abilitech ablelite device in the clinic and home environments. functional outcomes will include documenting active range of motion and the ability to perform activities of daily living (adls) using the standardized canadian occupational performance measure (copm) and the role evaluation of activities of life (real) assessments. secondary objectives are to assess the safety record and report on adverse events (aes) and parameters related to device usage, including device usage time and the time required to don/doff the device.


Eligibility criteria:
inclusion criteria: 1. subjects between 9 and 18 years of age, with pediatric onset of neuromuscular conditions that cause quadriparesis 2. mmt score of 1-3 in the elbow, wrist and hands, and an mmt score of 2- to 3 in the shoulder 3. ability of subject to raise their forearm off of their lap or laptray 4. willingness to comply and participate with the study protocol and attend the study sessions 5. ability to communicate verbally and respond to questions and commands 6. ability to provide informed consent 7. selected for participation based on investigator discretion exclusion criteria: 1. use of ventilator 2. open wounds or chronic pressure sores on upper extremities, neck, back or torso 3. significantly unstable upper extremity joints 4. unhealed bone fractures in the upper extremities 5. active rotator cuff tear, grade 2 or 3 6. surgical fixations limiting full passive range of motion 7. uncontrolled upper-limb spasticity that significantly limits normal range of motion 8. uncontrollable pain in the neck, shoulders or upper limbs 9. ability to fully raise both hands simultaneously above their head with ease 10. lack passive shoulder abduction of 120 degrees 11. lack 90 degrees of passive elbow extension 12. unable to follow instructions 13. exhibit significant behavioral problems 14. inability to provide consent
bexarotene treatment in schizophrenia

Conditions: Schizophrenia

Summary: in this proposed study, we aim to investigate the effects of bexarotene (targretin; lgd1069; 4-\[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl\] benzoic acid) on severity of psychopathology, cognitive impairment, and quality of life in schizophrenia patients in an open label trial. the rationale behind add-on oral bexarotene to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis (goodman, 1995) and the growth factors deficiency and synaptic destabilization hypothesis (moises et al, 2002) of schizophrenia. in this clinical trial, a novel regimen of low dose bexarotene (targretin, 75 mg/day) will be added for 6 weeks to the standard treatment of 15 schizophrenia patients on stable antipsychotic treatment. participants will be assessed at baseline and after 2, 4 and 6 weeks of treatment. a battery of research instruments will be used for assessment of efficacy and safety (psychopathology, and side effects). in addition, cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count will be monitored at baseline and during therapy.


Eligibility criteria:
inclusion criteria: * age 18-60 * schizophrenia * stable blood parameters * normal baseline fasting triglyceride * ability to sign informed consent exclusion criteria: * lipid abnormalities * leukopenia or neutropenia * organic brain damage (mental retardation) * alcohol or drug abuse * renal disease * hepatic dysfunction * history of pancreatitis * thyroid axis alterations * suicide attempt in past year * cataracts * systemic treatment with more than 15,000iu vitamin a daily * patients with known hypersensitivity to bexarotene or other components of the product * pregnant women

Keywords: bexarotene schizophrenia psychopathology cognitive impairment quality of life open lable trial
impact of a wearable fitness tracker on otolaryngologists' burnout

Conditions: Burnout; Stress; Sleep Deprivation; Wellness

Summary: study the impact of the whoop fitness tracker on burnout in attending and resident otolaryngologists

the study will be a randomized controlled trial of attending and resident otolaryngologists who will be randomized to either wearing a whoop fitness tracker or a control group. participants will take two maslach burnout inventory (mbi) surveys prior to the start of the intervention to set a baseline burnout score, and then at 3 months and 6 months into the study. baseline cardiac status will also be established by taking a pre-intervention heart rate and blood pressure.

Eligibility criteria:
inclusion criteria: * all attending and resident otolaryngologists at wake forest baptist health exclusion criteria: * users of a whoop device currently * current interns will be excluded given they do not work with the otolaryngology team the whole year

Keywords: burnout fitness tracker