Kornimate/medical-research-clean huggingface dataset:
regional block for postoperative free flap care

Conditions: Pain Management

Summary: the purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia for head and neck patients undergoing microvascular free flap reconstruction.

the increasing rate of opioid related overdose mortality is well documented in the literature and approached 15 per 100,000 in 2017. because of a growing epidemic in the us, the medical community is under scrutiny to curtail opioid prescription. however, this is weighed against surgical outcomes; importantly, postoperative pain has adverse effects on function, recovery and quality of life. regional anesthesia provides a non opioid based, pain control strategy. first, regional anesthesia decreases systemic adverse events including respiratory failure in abdominal surgery, decreases length of stay and improves rehabilitation in common orthopedic procedures such as total knee arthroplasty and shoulder arthroplasty. second, the physiologic benefits of regional anesthesia are compelling including augmented micro and macrocirculation, maintenance of body temperature and decreased systemic stress response through chemical sympathectomy. finally, regional anesthesia has been established as safe in the microvascular and anesthesia literature for pediatric, and adult patients.

Eligibility criteria:
inclusion criteria: * age \> 18 * able to consent for themselves * undergoing a head and neck surgery at uab with reconstruction using either a forearm free flap or a fibula free flap exclusion criteria: * age \< 18 * unable to consent for themselves * non-english speakers * non-resectable tumor * have a known opioid tolerance, or are on a home opioid regimen for a chronic condition. (short-term opioid use for diagnostic procedures (i.e. biopsy) or new cancer diagnosis will be allowed). * patients with known hepatic failure, renal failure, or sulfa allergy, as determined by standard of care labs drawn within 30 days of enrollment
the role of intestinal ultrasound in monitoring the response to biological therapy in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: in this study, the investigators aim to evaluate the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis

ultrasound examination is an easily accessible, non-invasive, radiation-free technique, and cheap imaging modality that is often chosen as the first diagnostic method in gastroenterology disease. performance of bowel ultrasound use of two different probes: low-frequency convex probe (3.0-3.5 mhz) and high-frequency linear probe (5-17 mhz) . inflammatory bowel disease (ibd) is a chronic inflammatory disease of the gastrointestinal tract, which clinically contains crohn's disease, ulcerative colitis, and other conditions. ibd is characterized by episodes of abdominal pain, diarrhea, bloody stools, weight loss, and the influx of neutrophils and macrophages that produce cytokines, proteolytic enzymes intestinal ultrasound has been shown to have high sensitivity and specificity in the detection or exclusion of intestinal inflammatory activity in ibd. advantages of intestinal ultrasound over other imaging modalities include non-invasiveness, rapid availability and low costs ,evaluation of bowel wall thickness, as well as stratification that reflects alterations in histopathology ulcerative colitis (uc). visualization of the vascularization of the bowel using color doppler sonography and, direct visualization of motility. a study done : ius is preferred for monitoring the disease course and for assessing short-term treatment response. found that monitoring bowel wall thickening (bwt) alone has the potential to predict the therapeutic response.the primary therapeutic goal in uc is to induce and maintain long-term disease remission; however, there is no single treatment pathwayguidelines recommend the use of either conventional therapies (i.e., aminosalicylates ..etc)or the use of biologic therapies ( infliximab.)

Eligibility criteria:
inclusion criteria: * any patient above age of 18 years old and diagnosed to have uc and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study * moderate to severe uc patients * immunosuppressant or corticosteroid refractory disease * those with intolerance or contraindication to conventional therapies are eligible to be treated with biological therapy exclusion criteria: * patients with uc who are under age of 18 years' old * patients with uc who aren't eligible to biological therapy * patients with complication of uc(fistula , intestinal obstruction , intestinal perforation ,......) * patient refuse to participate in the study.
oral glucose tolerance testing using candy for cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the study aims to determine if a popular dextrose candy alternative yields a similar glycemic curve compared to the standard oral dextrose solution used in the oral glucose tolerance test.


Eligibility criteria:
inclusion criteria: * males and females ages 10-21 years. * cystic fibrosis (cf) must be diagnosed. * ability to sign informed consent if they are 18 years or older. * written parental permission if age 10-17 years old. exclusion criteria: * active cf flare as determined by the primary cf team . * use of steroids. * inability to tolerate oral feedings. * prior intestinal surgery. * concern for allergy or intolerance to dextrose, fructose, or corn derivatives.
observational safety study of etanercept (enbrel) for treatment of psoriasis

Conditions: Psoriasis

Summary: this is an observational safety study tracking psoriasis patients on etanercept (enbrel) for 5 years.

this is a prospective, multi-center, observational surveillance registry to evaluate data on the long-term safety of etanercept (enbrel) use in the treatment of psoriasis.

Eligibility criteria:
inclusion criteria: * patients with plaque psoriasis exclusion criteria: * prior exposure to any tumor necrosis factor (tnf)-inhibitor * patients for whom enbrel is contraindicated * patients currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study.

Keywords: plaque psoriasis patients tnf-inhibitor naïve
a safety, efficacy and pharmacokinetics study of tofacitinib in pediatric patients with sjia

Conditions: Arthritis Juvenile Idiopathic

Summary: a randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. in the double-blind phase "time to sjia flare" will be evaluated as primary endpoint and subjects will be discontinued once they experience sjia flare. an interim analysis for efficacy and futility will be conducted when at least 20 flares have been observed. if either criterion is met, the study will be stopped. if neither criterion is met, the study will continue until the requisite number of flares are observed as determined by the number of flares included in the interim analysis and a statistical penalty for conducting the interim analysis.


Eligibility criteria:
inclusion criteria: * active sjia disease according to ilar criteria before screening and at baseline (day 1); * treatment with stable doses of methotrexate (mtx) ≤25 mg/week or ≤20 mg/m2/week, whichever is lower, is permitted; * treatment with a stable dose of oral prednisone ≤1 mg/kg/day up to a maximum of 30 mg/day, or equivalent, for at least 1 week before the first study drug dose is permitted. exclusion criteria: * previous juvenile idiopathic arthritis (jia) treatment with tofacitinib. * current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with systemic juvenile idiopathic arthritis (sjia). current symptoms or findings of more than minimal pleuritis with sjia. * current infection or serious infection within 3 months of study enrollment.

Keywords: systemic juvenile idiopathic arthritis xeljanz tofacitinib sjia cp-690 550
safety and efficacy of travoprost/timolol bac-free

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to demonstrate equivalent safety and iop-lowering effectiveness of two travoprost/timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. this global study will be conducted in the us (c-07-64, nct00672997) and japan (c-08-08, nct00760539).


Eligibility criteria:
inclusion criteria: * open-angle glaucoma or confirmed ocular hypertension. * mean iop in at least one eye, the same eye(s):22-36 mmhg at 9 am on eligibility visits 1 \& 2 and 21-36 mmhg at 11 am and 4 pm on eligibility visits 1 \& 2. * sign an informed consent form. * discontinued use of all iop-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the eligibility 1 visit. * other protocol-defined inclusion criteria may apply. exclusion criteria: * females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures. * any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension. * history or current evidence of chronic or recurrent severe inflammatory eye disease in either eye. * history or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. * best-corrected visual acuity (bcva) worse than 0.6 logmar in either eye. * severe central visual field loss in either eye. * not able to safely discontinue use of all iop-lowering ocular medication(s) according to the ocular hypotensive medication washout schedule. * history or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (copd) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker. * history or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study. * other protocol-defined exclusion criteria may apply.

Keywords: glaucoma hypertension
guided meditation as an adjunct to enhance postoperative recovery

Conditions: Feasibility of a Meditation Program Perioperatively

Summary: the primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period.

this is a prospective, randomized, controlled study involving 30 adult patients undergoing cardiac surgery. investigators will test the feasibility of implementing a meditation program in the perioperative period. patients will be randomized to one of three groups: those who complete isha kriya (ik) meditation before and after surgery, those who complete postoperative ik meditation only, and those who receive the standard of care with no meditation intervention. in addition to testing feasibility, the investigators will explore whether a meditation program can affect recovery after surgery. patients enrolled will be followed postoperatively for up to one month to assess their cognitive function, pain, and sleep. blood will also be collected for analysis of biomarkers of inflammation.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. undergoing any of the following types of cardiac surgery: cabg with or without valve surgery (aortic and/or mitral); isolated valve surgery; isolated aortic surgery 3. surgery scheduled for at least 14 days after enrollment exclusion criteria: 1. urgent and/or emergent surgery 2. non-english speaking 3. cognitive impairment as defined by total moca score \< 10 4. baseline dass-21 depression score \>10 5. pre-existing history of psychiatric illness as documented in the medical record or divulged in history taking in pre-enrollment patient interview, such as anxiety, depression, or bipolar disorder 6. history of cerebrovascular accident or recent history (\< 3 months) of seizures 7. history of dementia, parkinson's disease, alzheimer's disease, or other forms of cognitive decline 8. current use of cognition enhancing drugs 9. current management for chronic pain 10. currently enrolled in another interventional study that could impact the primary outcome, as determined by the pi 11. educational attainment below high school level or equivalent 12. significant visual impairment

Keywords: meditation cognitive dysfunction postoperative period cardiac surgery
the effect of intravenous glucocorticoids on the tearfilm in eyes with thyroid-associated ophthalmopathy

Conditions: Thyroid-associated Ophthalmopathy; Dry Eye Syndrome

Summary: thyroid-associated ophthalmopathy (tao), also called graves' ophthalmopathy or thyroid eye disease, is a common orbital disease in adults. patients with tao, especially in its active phase, often complain about symptoms of ocular surface discomfort, including excess tearing, gritty sensation, increased sensitivity to light and foreign-body sensation, which are similar to inflammatory ocular surface disorders such as dry-eye syndrome (des). incomplete blink, increased proptosis and greater palpebral fissure width in tao accelerates tear evaporation, which increases the tear fluid's osmolarity, and results in ocular surface damage. the administration of intravenous glucocorticoids can be an effective treatment for tao. the rationale of the present study is to assess the effect of intravenously administered glucocorticoids on the signs of des in patients with tao with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film and well established methods for assessment of the severity of des. additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years * active thyroid associated ophthalmopathy with clinical activity score (cas) of each eye more than 3 or recently experienced worsening of proptosis, lid retraction, or ocular motility disturbance. * normal ophthalmic findings except symptoms associated with tao * scheduled for treatment with systemic glucocorticoids according to the kahaly-scheme exclusion criteria: * chronic inactive tao * previous treatment with oral or intravenous glucocorticoids 3 months preceding the study * participation in a clinical trial in the 3 weeks before the screening visit * symptoms of a clinically relevant illness in the 3 weeks before the first study day * presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator * wearing of contact lenses * intake of dietary supplements in the 3 months preceding the study * topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants * ocular infection * ocular surgery in the 3 months preceding the study * sjögren's syndrome * stevens-johnson syndrome * pregnancy, planned pregnancy or lactating

Keywords: methylprednisolone dry eye syndrome tear film thyroid-associated ophthalmopathy
a new more efficient cycloplegia scheme

Conditions: Refractive Errors

Summary: the purpose of this study is to determine whether tropicamide + phenylephrine cyclopentolate + applied for once waiting 30 minutes to retinoscopy (new scheme) is not inferior to apply cyclopentolate alone and wait 45 minutes to retinoscopy (traditional scheme)


Eligibility criteria:
inclusion criteria: * children between 1 and 10 years exclusion criteria: * strabismus * ocular surgery * another ocular disease than ametropias (i.e uveitis, cataract) * cardiovascular or neurologic disease. * allergy to any of drugs used in the study

Keywords: cycloplegia refraction in children cycloplegic agents cycloplegic schemes cyclopentolate
women's estrogen for stroke trial (west)

Conditions: Stroke

Summary: to determine if estrogen hormone replacement therapy reduces the risk of stroke or death in postmenopausal women who have already had stroke or a transient ischemic attack (tia).

the researchers enrolled 664 postmenopausal women with an average age of 71 years who had experienced an ischemic stroke or a tia within the previous 90 days. ischemic strokes and tias result from blockages in the vessels that supply blood to the brain. participants were given a number of initial assessments, including the nih stroke scale (nihss) of neurological impairment and the barthel index of functional ability in activities of daily living. in addition to the usual best care for patients who have had a stroke, women in the trial received either oral estrogen (estradiol 17-beta at the standard replacement dose of 1 mg daily) or a matching placebo. patients were studied for an average of 2.8 years. they stopped receiving the estrogen or placebo if they had a stroke. the researchers found that there was no significant difference in the incidence of stroke or death in the women who were randomly assigned to receive estrogen instead of placebo. however, they found that the incidence of death due to stroke was higher in the estrogen group and that the non-fatal strokes in that group were associated with slightly worse neurological and functional impairments at 1 month after stroke. the risk of stroke within the first 6 months after enrollment in the study was also higher among women in the estrogen group. there were no significant differences between treatment groups in the number of tias or non-fatal heart attacks. however, participants receiving estrogen were more likely to experience gynecologic complications, particularly vaginal bleeding.

Eligibility criteria:

Keywords: stroke estrogen
trial of mifepristone in combat veterans with posttraumatic stress disorder

Conditions: Posttraumatic Stress Disorder

Summary: the investigators propose to conduct a randomized double-blind, parallel-group, placebo-controlled trial of mifepristone in veterans with military-related posttraumatic stress disorder (ptsd). this study will examine the clinical, neuropsychological, and neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to determine if this treatment is efficacious in improving ptsd symptoms, cognitive functioning, or other related clinical measures. additionally, the investigators will observe whether baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity are associated with treatment outcome.


Eligibility criteria:
inclusion criteria: * subject is a male u.s. veteran * subject was exposed to combat or another criterion a traumatic event during military service * subject meets diagnostic criteria for chronic ptsd exclusion criteria: * veteran has a history of adrenal insufficiency or a plasma cortisol level less than 5 mcg/dl at screening * veteran has a moderate-severe traumatic brain injury, a history of a stroke, or another neurological illness or injury likely to impact cognitive functioning * veteran has diabetes mellitus, an endocrinopathy, or another major medical illness. * veteran is taking oral corticosteroids * veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder * veteran is currently suicidal or otherwise is in need of urgent clinical care * veteran is currently receiving specialized trauma-focused psychotherapy (i.e., prolonged exposure, cognitive processing therapy or eye movement and desensitization reprocessing). * veteran is not willing to use effective means of birth control during the study or for 90 days after taking study medication * veteran has history of allergic reaction to mifepristone
early cycle ergometry for critically-ill liver failure patients in a transplant intensive care unit

Conditions: Liver Cirrhoses; Liver Failure; ICU Acquired Weakness

Summary: critically-ill patients with liver disease are at high risk of developing sarcopenia and intensive care unit (icu)-acquired weakness, which are associated with mortality and other poor outcomes. early physical rehabilitation has shown benefit in icu settings, but has not been studied in icu patients with acute and chronic liver failure. cycle ergometry, or stationary cycling in passive and active modes, may be especially beneficial to such patients due to their high prevalence of severe physical deconditioning and variable mentation. the aim of this study is to examine the feasibility, safety, and benefit of cycle ergometry over standard physical and occupational therapy (pt/ot) in critically-ill patients who have acute or chronic liver disease.

a single-blinded randomized controlled trial will be conducted in a transplant intensive care unit (ticu). eligible adult patients will be enrolled within 72 hrs after ticu admission and randomly allocated to either (1) standard pt/ot care, or (2) pt/ot care and cycle ergometry sessions with trained pt/ot therapists or technicians. the outcome measures, tests of strength and function, will be assessed at baseline, every 14 days, and upon ticu discharge by a blinded pt/ot therapist.

Eligibility criteria:
inclusion criteria: * adults 18 ≥ years with acute or chronic liver disease admitted to transplant intensive care unit (ticu), or admitted to ticu following a liver or liver-kidney transplant * expected to remain in icu for ≥ 5 days * spoken english fluency exclusion criteria: * known primary systemic neuromuscular disease or intracranial process causing increased intracranial pressure * lower extremity amputation * anticipated death or palliative withdrawal of life support within 5 days * cycle ergometer weight limit (135 kg or 297.6 lbs per manufacturer)

Keywords: cycle ergometry physical therapy rehabilitation
animal-assisted resilience training for children with stressful life events or autism spectrum disorder

Conditions: Autism Spectrum Disorder; Life Change Events

Summary: the goal of this clinical trial is to learn about the effects of an animal-assisted resilience training in children who experienced stressful life events or who have a diagnosis of autism spectrum disorder. the main question it aims to answer is: • is an animal-assisted resilience training a feasible approach to increase resilience in children with a history of stressful life events or a diagnosis of autism spectrum disorder? participants will take part in 12 training sessions of a standardized resilience training. the training is group-based, takes place outdoors, and includes interactions with different animals. it focuses on self-esteem, self-perception, dealing with emotions, and social competence.


Eligibility criteria:
inclusion criteria: * age between 2 and 4 years (toddler group) or 8 and 12 years (children group) * history of at least one stressful life event experience or diagnosis of autism spectrum disorder * basic knowledge of either german or english of parents and child to follow the instructions during the training sessions and completion of interviews. exclusion criteria: - medical contraindications for contact with animals, such as allergies or phobia