Kornimate/medical-research-clean huggingface dataset:
rapid structural and functional improvements in following 0.19 mg fluocinolone acetonide (fac) implant in diabetic macular edema patients with poor visual acuity: 12-month audit results from united arab emirates

Conditions: Diabetic Macular Edema

Summary: the health authority - abu dhabi (haad) approved the reimbursement of the slow release fac implant (iluvien) and it is now available for the treatment of diabetic macular edema (dme) in persons who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. we performed a retrospective 12-month audit to assess the efficacy and safety of the fac implant in our clinical practice.

twenty patients with pseudophakic lenses, treated with iluvien, were investigated to evaluate functional and anatomical characteristics and outcomes (visual acuity \[va; etdrs letters score\], central macular thickness \[cmt\] and intraocular pressure \[iop\]) at baseline, weeks 2-4 and months 3, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * dme * pseudophakic exclusion criteria: * other causes of macular edema. * phakic * know case of gaucoma
safety and efficacy of recombinant human platelet-activating factor acetylhydrolase for the treatment of severe sepsis

Conditions: Sepsis

Summary: the objective of this study is to demonstrate that rpaf-ah is safe and reduces 28 day all cause mortality in patients with severe sepsis.

this study is a randomized, double-blind, placebo-controlled, multicenter study of rpaf-ah compared to placebo in patients with severe sepsis. eligible patients from investigative sites located throughout the united states and other countries will be randomized to receive either rpaf-ah or placebo administered daily for five consecutive days by intravenous (iv) infusion. all patients will be evaluated for safety and efficacy endpoints over 28 days. a follow-up evaluation will occur approximately 6 months after day 28 to assess functional status and quality of life.

Eligibility criteria:
inclusion criteria * clinical diagnosis of severe sepsis * at least 18 years old * patient or legally authorized representative able to provide informed consent exclusion criteria * severe lung injury (acute respiratory distress syndrome) * immunocompromised * severe liver disease * inflammation of the pancreas, organ rejection, or burns to more than 30% of body * enrolled in another clinical trial * already participated in this or other rpaf-ah study * there is not a commitment to aggressive treatment * has a disease with life expectancy less than 6 months

Keywords: severe sepsis platelet-activating factor acetylhydrolase
the optica study - the optimised computed tomography pulmonary angiography (ctpa) in pregnancy, quality and safety study

Conditions: Pulmonary Embolism; Pregnancy Related; Venous Thromboembolism

Summary: a prospective multicentre study aiming to validate the clinical utility and safety of an optimised low-dose computed-tomography pulmonary angiogram (ctpa) protocol for suspected pulmonary embolism in pregnancy

the optica study is the first prospective study of a low-dose ctpa protocol for the pregnant population. it will define the achievable dose, image quality and safety of this protocol and provide an evidence base upon which modern ctpa protocols can be appropriately compared to scintigraphy for this population. pregnant women undergoing the specified low-dose ctpa protocol for suspected pulmonary embolism (pe), agreed across study sites with equivalent computed-tomography (ct) capabilities, will be included. independent review of ctpas by two radiology consultants, image data analysis and 3-month patient follow up will be performed. the diagnostic algorithm employs chest-x-ray and lower limb doppler if lower limb symptoms are present, followed by ctpa in cases where advanced imaging is required. d-dimer is permitted within the diagnostic algorithm for patients recruited after implementation of the updated 2019 "european society of cardiology guidelines for diagnosis and management of acute pulmonary embolism".

Eligibility criteria:
inclusion criteria: 1. pregnant patients with a suspected pulmonary embolism 2. age≥18 years exclusion criteria: 1. age \< 18 years 2. ultrasound proof of symptomatic proximal deep vein thrombosis 3. contraindication to helical ct because of allergy to intravenous iodinated contrast or renal insufficiency (creatinine clearance \<30 ml/min) 4. treatment with full-dose therapeutic low molecular weight heparin or unfractionated heparin initiated 24 h or more prior to eligibility assessment 5. treatment with vitamin k antagonists (coumarin derivates i.e. warfarin) 6. unable or unwilling to consent 7. unable to part-take in follow-up 8. life expectancy \<3 months

Keywords: pulmonary embolism pregnancy tomography xray computed radiation dosage negative predictive value
to evaluate the pharmacokinetic of diacerein and rhein after maximum use in patients with epidermolysis bullosa (eb)

Conditions: Epidermolysis Bullosa (EB); Epidermolysis Bullosa Simplex; Dystrophic Epidermolysis Bullosa; Junctional Epidermolysis Bullosa

Summary: a pharmacokinetic (pk) study in 16-20 eb subjects to be allocated to two cohorts. cohort 1 to include 8-10 subjects (ages 12 yrs and older); cohort 2 to include 8-10 subjects (ages 6 months-11 yrs, inclusive). cohort 2 only included subjects 4 yrs and older. serial pk blood sampling collected on days 1 and 10. analyses were performed to determine the concentrations of diacerein and rhein.

this was an open-label, single-period study that intended to include subjects with eb consisting of infants/ children (ages 6 months to 11 years, inclusive) and adolescents/ adults (ages 12 years and older). the study included 2 cohorts. cohort 1 was to include adolescent/adult subjects with eb (ages 12 years and older); cohort 2 was to include infants/children with eb (ages 4 to 11 years, inclusive). for both cohorts, the study intended to enroll subjects with epidermolysis bullosa simplex (ebs), dystrophic epidermolysis bullosa (deb), and junctional epidermolysis bullosa (jeb) with lesions encompassing \>/=2% bsa. the diacerein application area was \>/=5% bsa and included lesioned and non-lesioned skin (if lesions accounted for \<5% bsa); however, topical administration was \</=30% bsa. on days 1 and 10, the topical dose of study drug was applied by study staff, and blood was sampled for pk analyses of diacerein and rhein pre-dose and through 8 hours post-application. on days 2 to 9, study drug was applied to the application area(s) at home. for cohort 1, trough pk samples were collected on any 2 available days from days 3 through 9, and study drug was applied after blood draw, while for cohort 2 trough pk analyses were not performed.

Eligibility criteria:
key inclusion criteria: * at least 12 years of age (cohort 1) or at least 6 months of age to 11 years, inclusive (cohort 2) at screening. for us only: at least 4 years of age to 11 years, inclusive (cohort 2) * the subject must weigh at least 9 kg (19.8 lbs) at screening. * subject has a documented genetic mutation consistent with eb. * subject has eb lesions on ≥ 2% body surface area (bsa) and the eb lesions are in the following body areas: a. localized: plantar and/or palmar areas, b. generalized: arms, legs, torso, hands and feet. key exclusion criteria: * subject has eb lesions where drug will be applied that are infected * subject has used any diacerein containing product within 1 month prior to visit 1 * subject has used systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to dosing. * subject has used systemic steroidal therapy or has used topical steroidal therapy on the eb lesions in the application area within 14 days prior to dosing * subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to dosing

Keywords: eb ebs deb jeb
teen-to-teen videos to improve electronic medical record portal knowledge and personal health information engagement

Conditions: Inflammatory Bowel Diseases

Summary: the goal of this clinical trial is to compare whether videos help teens better understand medical topics. the main questions answered in this trial are: 1. whether videos can improve teen knowledge about electronic medical record portals 2. whether videos can improve teen knowledge about general health issues participants will answer surveys and watch videos as part of this study.

investigators performed a randomized controlled trial of education videos addressing one of two topics: a) electronic medical record portals and information shared therein and b) general adolescent health issues among adolescents and young adults with inflammatory bowel diseases. investigators evaluated the efficacy of each in increasing participant knowledge in that arena.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of inflammatory bowel disease * english proficient exclusion criteria: - unable to give consent
the effect of aerobic and resistance training in patients with type 2 diabetes on vitamin d

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study protocol is to assess the effect of concurrent aerobic and resistance training in patients with type 2 diabetes on vitamin d treatment

aerobic and resistance training can effectively improve clinical management in people with type 2 diabetes (t2d), leading to improvements in various health parameters, including cardiovascular health, insulin sensitivity, and muscle mass. low vitamin d (vitd) levels are associated with t2d risk and metabolic disturbances, and some studies suggest that vitd may help reduce this risk, particularly in individuals with low vitd levels. however, the effect of exercise in t2d patients on vitd remains inconclusive due to limited and inconsistent research findings. the aim of this study is to investigate the effect of aerobic and resistance training on clinical parameters in patients with t2d on vitd. the diavitex study is a double-blind randomized clinical trial, including 80 individuals of both sexes (female, male) with a confirmed diagnosis of t2d and on a vitd treatment where a combination of exercises will be examined. patients will be selected at the primary care centers assigned for the study and randomly assigned to four groups: 1-training-vitd (n=20); 2- training (n=20), 3- vitd (n=20) and 4- no vitd (n=20). in this study, a sarcoplasm stimulating training program will be carried out online, three sessions per week for a total of 16 weeks. subjects will perform fitness tests, as well as analysis of glycated hemoglobin, insulin resistance, lipid profile and blood inflammatory biomarkers. nutritional education programs will be designed and provided to all participants. expected improvements in insulin resistance, glycated hemoglobin, lipid profile, and inflammatory markers are anticipated following a 16-week regimen of exercise in patients with t2d on vitd.

Eligibility criteria:
inclusion criteria: * adults (females or males) older than 18 years old with a diagnosis of t2d in the clinic database * patients only taking metformin with stable medication for the last 3 months exclusion criteria: * patients taking other medication different than metformin (including combinations and insulin) * patients taking polyvitaminic supplementation at the inclusion for at least, 1 month before the intervention * female subjects who are pregnant

Keywords: vitamin d aerobic training resistance training insulin resistance
atrx/daxx in eus-fnb specimens of pan-nets

Conditions: Pancreatic Neuroendocrine Tumor

Summary: p-nens are classified as functional (f-) or non-functional (nf-) depending on the presence or absence of a clinical hormonal hypersecretion syndrome. moreover, the who 2017 classification of pnens distinguishes between well-differentiated pancreatic neuroendocrine tumors (pnets) and poorly differentiated pancreatic neuroendocrine carcinomas (pnecs). pnets are then divided according to a grading scheme based on ki67 index in pnets-g1 (ki67 index ≤3%) and pnets-g2 (ki67 index between 4% and 20%). pnecs are all g3, with a ki67 index \>20%. endoscopic ultrasound with fine-needle biopsy (eus-fnb) demonstrated safe and effective preoperative grading based on the ki-67 proliferative index. however, downstaging rate is not neglectable, reaching 15% in a recent metanalysis. moreover, recent whole-exome and whole genome sequencing studies revealed that the mutually exclusive inactivating mutations in death domain-associated protein (daxx) and/or in α-thalassemia/mental retardation x-linked (atrx) chromatin remodeling genes are associated with more aggressive disease. in a retrospective study, the investigators recently evaluated the correspondence of daxx/atrx expression on 41 eus-fnb samples with corresponding surgical specimens demonstrating a 95.1% (almost perfect agreement, κ = 0.828; p \< 0.001) and 92.7% (substantial agreement, κ = 0.626; p \< 0.001) concordance for daxx and atrx expression, respectively. this study aims to evaluate the potential clinical/prognostic role of daxx/atrx expression as implementation of the currently used ki67-based grading, evaluated on eus-fnb samples in a prospective cohort of patients with nf-pnets


Eligibility criteria:
inclusion criteria: * age ≥18 years * cyto/histologic diagnosis of pnets * signed informed consent exclusion criteria: * functional pnets * multiple pancreatic nodules * diagnosis of men-1 or von-hippel lindau * mixed types (e.g., mixed neuroendocrine-acinar/adenocarcinoma) or neuroendocrine carcinomas * predominantly cystic lesions (more than 50% of the volume). * metastatic tumors at the time of diagnosis * known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma * use of anticoagulants that cannot be discontinued * inr \>1.5 or platelet count \<50.000 * pregnancy or breastfeeding * failure to sign the patient's or closest relative's informed consent
circadian rhythm and attack-timing in episodic cluster headache patients in- and outside of bout: an actigraphic study

Conditions: Cluster Headache

Summary: the aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.

the aim is to investigate circadian rhythm in episodic cluster headache patients in- and outside of bout. this will be done using actigraphy and a short diary for 2 weeks in each period. a secondary outcome is to look at attack occurence and physical activity before and during an attack.

Eligibility criteria:
patients inclusion criteria: * age between 18 and 65 years of age * episodic cluster headache * the patient can differentiate cluster headache from other primary headaches if he suffers from any. exclusion criteria: * circumstances, determined by the pi, that makes the patient ineligible. * changes in preventive medication within 7 days before the study initiation and during the 2 weeks. * changes in antidepressive medication or antipsychotic medication within 2 weeks before the study initiation and during the 2 weeks. * serious somatic and/or psychiatric disorders * alcohol intake \> 50 units pr.week * pregnancy / breastfeeding * patient cannot accept the conditions of the trial * patient does not understand danish. controls inclusion criteria: - age between 18 and 65 years of age exclusion criteria: * circumstances, determined by the pi, that makes the patient ineligible. * any primary headache more than 1 day / month * diagnosed with a secondary headache * treatment with antidepressive medication or antipsychotic medication within 2 weeks before the study initiation and during the 2 weeks. * serious somatic and/or psychiatric disorders * alcohol intake \> 14 / 7 units pr.week (males / females) * pregnancy / breastfeeding * patient cannot accept the conditions of the trial * patient does not understand danish.

Keywords: cluster headache actigraphy circadian rhythm
ketamine frequency treatment for major depressive disorder

Conditions: Treatment Resistant Depression

Summary: depression is a wide spread illness. depression contributes most significantly to national health care costs. while the number and types of treatments used for depression have expanded over the years, even with an increased range of options, the response rate, defined as the number of subjects who have a 50% reduction in depressive symptoms, is estimated to be around 65%. this randomized clinical trial will examine the frequency of treatment with ketamine in patients with treatment-resistant depression trd without psychosis. it will compare two modes of the ketamine treatment; every other day ketamine, versus two active and four placebo treatments over the period of 12 days.


Eligibility criteria:
inclusion criteria: * age 30 to 65 * major depressive disorder without psychotic features confirmed by a structured clinical diagnostic interview, scid. * treatment resistant depression defined using the antidepressant treatment history form (athf) * hdrs 21 score \> 18 * female participants of childbearing potential must be using a medically accepted means of contraception (birth control pills, spermicidal barrier) * ability to concur with medication standardization regiment (section as an outpatient * physically healthy (no chronic diseases; normal cbc, bmp, ast, alt, and ua) * competent to give informed consent to all required tests and examinations and sign a consent document exclusion criteria: * bipolar disorder * psychosis or any other psychotic disorder as defined by dsm-iv criteria * serious or imminent threat for suicide * pregnant or nursing female * presence of serious unstable medical illnesses including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, or abnormal laboratory tests (cbc, bmp, ast, alt, and ua) * uncontrolled hypertension * history of cva * treatment with st. johns wort, tramadol, phentolamine, naloxone, or anticholinergic medications * alcohol or illicit drug abuse for 6 months (evidence from uds) * currently involved in a clinical trial or used an experimental medication within the last 30 days * hypersensitivity to ketamine products
gx-i7 with cyclophosphamide in patients with metastatic or recurrent solid tumors

Conditions: Solid Tumor

Summary: this is a phase 1b study to explore the safety and efficacy of gx-i7 in combination with cpa in patients with metastatic or recurrent solid tumors.

this is a phase 1b study to explore the safety and efficacy of gx-i7 in combination with cpa in patients with metastatic or recurrent solid tumors. this is 4 dose levels and increase dose level after confirm dlt of the previous dose.

Eligibility criteria:
inclusion criteria: * histological confirmation of solid tumor, for which no standard therapy exists or is available any longer. * aged ≥19 years(korean age). * eastern cooperative oncology group (ecog) performance status of 0 or 1. * life expectancy ≥12 weeks. * adequate hematological and end organ function defined by the following * laboratory results obtained within 14 days prior to cycle 1 day 1 (c1d1) * female subjects of childbearing potential (including a female who has undergone tubal ligation) requires a negative serum pregnancy test performed within 14 days prior to c1d1. * have an evaluable lesion(s) by response evaluation criteria in solid tumors (recist) v1.1 * subjects to be enrolled in the phase 2a stage must be able to provide pre-treatment tissue biopsy or archival tissue and must have a tumor lesion. * providing the signed informed consent form (icf). exclusion criteria: * unable to adhere to the study procedures and follow-up procedures. * pregnant or lactating subjects. * have alcoholic or other hepatitis, liver cirrhosis, or genetic liver disease. * have uncontrolled type 2 diabetes mellitus. * have history of a major surgery within 28 days prior to c1d1 or are anticipated to require a major surgery during the study. * have an evidence of severe or uncontrolled systemic disease, uncontrolled hypertension. * have received any other investigational or approved anticancer therapy within 3 weeks prior to c1d1. * with a positive result of human immunodeficiency virus (hiv) infection.
comparison of bracing with co-aptation splinting for the initial treatment of acute humeral shaft fractures: the cobras trials

Conditions: Humeral Fractures

Summary: the goal of this study is to determine which initial method of immobilization for humeral shaft fractures in the emergency room maximizes patient comfort. the two methods of initial management for humeral shaft fractures are sarmiento bracing (pre-fabricated fracture brace) and coaptation splinting. in this study, the team will compare patient related outcomes and comfort for each method of initial management of humeral shaft fractures. participant pain, narcotic usage, and function will be tracked over a 2 week period to see which method of immobilization is preferred.


Eligibility criteria:
inclusion criteria: 1. presenting to an emergency room or icare in the participating centers with an acute humeral shaft fracture 2. age above 18 and skeletally mature 3. isolated injury 4. treated non-operatively first 2 weeks exclusion criteria: 1. open fractures 2. poly trauma 3. injuries deemed operative by attending surgeon 4. patients undergoing treatment for malignancy 5. prisoners

Keywords: sarmiento brace coaptation splint
furlow with buccinator and velopharyngeal function

Conditions: Cleft Palate

Summary: assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by arc (furlow z-palatoplasty with a buccinator myomucosal flap) was done. middle ear function was assessed by clinical otoscopic examination and by tympanometry to detect the presence or absence of middle ear effusion and the need for tympanostomy tubes. speech outcomes were assessed using perceptual speech assessment for the degree of hypernasality, compensatory misarticulation and speech intelligibility. nasopharyngoscopic examination of the patients was done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap


Eligibility criteria:
inclusion criteria: * - age 3 to 7 years * 1ry cleft repair by furrolow with buccal myomucosal flap * non syndromic previously treated children * cleft repaired by the same surgeon exclusion criteria: * - syndromic patient * cleft palate repair by any technique except furlow with buccal myomucosal flap
determining the most efficient screening cut off levels for phenylketonuria (pku)

Conditions: PKU

Summary: studying the screening of pku in france with the new tandemms

nationwide cohort study of the new pku screening for patient beetwen 180 and 360 µmol/l.

Eligibility criteria:
inclusion criteria: * having screening in france exclusion criteria: * refusing neonatal screening

Keywords: screening