Kornimate/medical-research-clean huggingface dataset:
tofacitinib for inflammatory eye disease

Conditions: Uveitis; Scleritis

Summary: non-infectious inflammatory eye disease, such as uveitis and scleritis, is a chronic, auto-immune process that leads to vision loss. while steroids are effective in the short term, the side-effect profile of chronic steroid use necessitates the identification of effective steroid-sparing therapies. tofacitinib is a small molecule that inhibits the signaling pathways of multiple inflammatory cytokines. the investigators plan to evaluate whether tofacitinib may have efficacy for patients with uveitis and / or scleritis.

this study is a prospective, single-site, open-label investigation of tofacitinib for refractory uveitis. the study will be for 24 weeks, with potential 1-year extension for treatment responders. the patients will self-administer the medication. eligible patients would be those patients with a diagnosis of uveitis who meet the following criteria: 1. disease sufficiently severe to require treatment with systemic corticosteroids, and 2. referred from ophthalmology to rheumatology or uveitis specialist for a steroid-sparing agent for patients naive to oral steroid-sparing therapy (e.g., methotrexate, azathioprine, or mycophenolate), tofacitinib will be initiated as monotherapy. for patients who have failed or had only a partial response to oral steroid-sparing therapy, tofacitinib will be initiated as an add-on therapy. for patients intolerant to a conventional agent, tofacitinib will be initiated as replacement monotherapy. for patients who have failed biologic therapy (e.g. adalimumab), biologic therapy will be discontinued and tofacitinib will be initiated as replacement therapy without change to concurrent conventional steroid-sparing agents. study visits will occur at baseline/enrollment, and weeks 4, 8, 12, 16, \& 24 (+/- 2 weeks). clinic visits may occur more frequently as determined by the treating physician. laboratory monitoring (table 1) will be obtained according to standard of care for drug toxicity monitoring. clinical responses will be evaluated at 24 weeks, with the primary outcome defined as treatment failure. all patients will undergo a predetermined oral steroid taper starting at 60mg of prednisone (or equivalent) and tapering over 14 weeks (table 2). all patients will undergo a predetermined topical steroid drop taper starting at their current dose (table 3). patients will have an ophthalmological evaluation by their treating ophthalmologist at washington university. steroid sparing therapy will be managed by rheumatologists or uveitis specialists at washington university. all patients will be evaluated for an associated systemic rheumatologic condition.

Eligibility criteria:
inclusion criteria: * diagnosis of uveitis * a clinical response to steroids * active disease requiring at least 10mg of prednisone daily (or steroid equivalent) exclusion criteria: * suspected or confirmed ocular infection * chronic or recurring infections, such as hiv * renal insufficiency that would preclude safe administration of tofacitinib
anifrolumab real-world treatment outcomes in systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: the polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine clinical practice.

this is multicenter, observational, cohort study designed to collect longitudinal data on the management and clinical outcomes of patients with sle that received anifrolumab in the scope of routine clinical practice within the frames of national drug program (ndp) for up to 30 months (\~ 6 months baseline and \~24 months follow-up date).

Eligibility criteria:
inclusion criteria: 1. adult (aged ≥18 years old) patients with sle who received anifrolumab treatment in the frames of ndp in poland. 2. patients willing to participate in the study and signed informed consent form (icf). exclusion criteria: 1. those who participated in anifrolumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first anifrolumab infusion through ndp. 2. cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Keywords: anifrolumab systemic lupus erythematosus sle observational
the real world of acute cholecystitis

Conditions: Acute Cholecystitis

Summary: meta-analysis of randomized controlled trials and population based studies in acute cholecystitis are in favor for early laparoscopic surgery versus a delayed operation several weeks later. the main problems in these studies are the exclusion criteria used, thus not reflecting the real world setting of acute cholecystitis. the purpose of this study is to demonstrate that a delayed laparoscopic cholecystectomy in a real world scenario has no worse outcome in comparison with an early operation (within 72 hours after onset of symptoms).

background: randomized controlled trials (rcts) and population based studies are in favor of an early operation in acute cholecystitis (1, 2). thus, one of the largest rct so far, demonstrated significant more complications in a group of delayed cholecystectomy. the main problems in these studies are the exclusion criteria used, ie severe cases are not considered. objective: in a cohort study all cholecystectomy patients are analysed to demonstrate that delayed laparoscopic cholecystectomy (dlc) in a real world setting has a less complication rate than early cholecystectomy (elc). setting: academic teaching hospital with 400 beds, seven departments (anesthesiology and intensive care medicine, orthopaedics and trauma surgery, visceral and thoracic surgery, gastroenterology, cardiology, gynecology and obstetrics, psychiatry. the visceral and thoracic department has a main focus on minimally invasive techniques. participants: all cholecystectomy patients during 1/2006 and 9/2015 variables: clavien dindo complication score, american society of anaesthesiologist (asa) score, conversion rate, onset of symptoms, histology, hospital stay data sources: chart analyses

Eligibility criteria:
inclusion criteria: * all patients with cholecystectomies exclusion criteria: * no exclusion criteria

Keywords: acute cholecystitis early versus delayed surgery
non-invasive brain stimulation for the treatment of psychiatric disorders

Conditions: Mental Disorders

Summary: the purpose of this study is to determine whether transcranial direct current stimulation (tdcs) is effective in the treatment of psychiatric disorders in which available treatments are either ineffective or not tolerated

depending on the specific psychiatric disorder, inhibitory or stimulating neuromodulation will be applied over the cortical region of interest, found according to the relevant scientific publication on neurophysiology of psychiatric disorders

Eligibility criteria:
inclusion criteria: * a psychiatric disorder in which available treatment are either ineffective or not tolerated exclusion criteria: * implantable active devices
a study of cln-978, a subcutaneously administered cd19-directed t cell engager, in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis (RA

Summary: a phase i, open-label study of cln-978 in patients with treatment-refractory rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * documented diagnosis of ra which fulfills the 2010 american college of rheumatology (acr)/european league against rheumatism (eular) classification criteria ≥12 weeks prior to screening. * evidence of b-cell-driven disease at screening or previous medical documentation, defined as either (i) seropositivity for rf and/or any ampa and/or (ii) a synovial biopsy showing b-cell infiltration * active ra disease, as demonstrated by a das28 - esr ≥3.2 and at least one swollen joint at screening. * inadequate response to at least 2 targeted treatments with different mechanisms. these can include tsdmard and/or bdmard, after failing conventional synthetic dmard (unless contraindicated). * local laboratory assessments must meet the following criteria: * absolute lymphocyte count (alc) ≥0.5 x 10\^9/l * peripheral cd19+ b cell count ≥25 cells/μl * absolute neutrophil count (anc) ≥1.0 x 10\^9/l * hemoglobin (hgb) ≥8 g/dl * platelet count ≥75 x 10\^9/l * estimated glomerular filtration rate (egfr) (based on the chronic kidney disease epidemiology collaboration \[ckd-epi\] formula) ≥30 ml/min/1.73m\^2 * total bilirubin ≤1.5 × uln, except patients with confirmed gilbert's syndrome * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤2.5 × uln * concurrent corticosteroids is permitted if the dose is ≤10 mg/day prednisone equivalent in the 2 weeks prior to initiation of study treatment. hydroxychloroquine ≤400 mg/d or chloroquine ≤ 250 mg/d is allowed. exclusion criteria: * active inflammatory disease other than ra within 12 months prior to screening or during screening that may interfere with the study assessments. thyroiditis or secondary sjogren's syndrome is allowed. * clinical evidence of any other significant unstable or uncontrolled acute or chronic disease not due to ra which, in the opinion of the investigator could put the patient at undue risk or confound study results. * prior treatment with the following: * cellular therapy (e.g., chimeric antigen receptor t-cell (car-t) or gene therapy product directed at any target. * receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to day 1 and during the study. * received any anti-cd19 or anti-cd20 therapy such as blinatumomab, obinutuzumab, rituximab, ocrelizumab, or ofatumumab within 3 months prior to day 1. * non-biologic dmard within 14 days prior to day 1. * cyclophosphamide or a biologic immunomodulating therapy within 2 months of day 1. * live or live-attenuated vaccines within the 4 weeks prior to the screening visit or during the screening period * active or latent tuberculosis (tb) evidenced by a positive or indeterminant interferon gamma release assay (igra), unless the patient has documented previous completion of tb treatment and no current clinical indication of tb.

Keywords: ra treatment-refractory ra
correlation between intestinal microecology imbalance and stroke in young adults

Conditions: Ischemic Stroke; Hemorrhagic Stroke

Summary: the relationship between the intestinal microecology and stroke has become a research hotspot in neurology field today. maintaining the balance of the intestinal microbiota are expected to bring new breakthroughs for prevention and treatment of stroke. in recent years, stroke in young adults has an increasing incidence and a considerable socioeconomic impact because of high disability rate and health-care costs. so there is an urgent need to explore the role and mechanism of intestinal microecology imbalance in stroke, especially in the development and prognosis of stroke in young people. this study aims to use multi-omics technologies, including microbial diversity, metagenomics and metabonomics, to reveal the characteristics of intestinal flora in young stroke patients, identify biomarkers for predicting outcome after stroke and early detection of young people at high risk of stroke, and to further explore the role of gut-brain axis in the pathogenesis of stroke.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute ischemic or hemorrhagic stroke * admission within 12 hours * aged 18-45 years exclusion criteria: * history of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases * combined with tumors, inflammatory bowel disease and other digestive system diseases * combined with serious life-threatening diseases or condition * any antibiotics, probiotics or prebiotic treatment within 3 months * deteriorate and die before collecting faecal samples

Keywords: ischemic stroke hemorrhagic stroke intestinal microecology multi-omics analysis prognosis
obesity guidelines for outpatient surgery

Conditions: Obesity

Summary: the investigators are concerned about anesthetizing obese children in outpatient locations in case they need prolonged stay, increased respiratory interventions, or need for post-operative narcotics. the investigators will be using a screening guideline to help us determine the higher risk child based on bmi and co-morbid conditions. the investigators will also be doing a retrospective chart review of 300 patients with bmi 95% and looking at various factors during the operative and post-operative period.


Eligibility criteria:
inclusion criteria: * patients 95% or over bmi having outpatient surgery.
a study of darbepoetin alfa for the treatment of anemia in subjects with non-myeloid malignancy receiving multicycle chemotherapy

Conditions: Anemia; Non-Myeloid Malignancies

Summary: the purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.


Eligibility criteria:
inclusion criteria: * non-myeloid malignancy * at least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule * eastern cooperative oncology group performance status of 0-2 * hemoglobin concentration of less than 11 g/dl within 24 hours before randomization * of legal age at the time written informed consent is obtained exclusion criteria: * known history of seizure disorder * known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy * unstable or uncontrolled disease/condition, related to or affecting cardiac function * clinically significant inflammatory disease * inadequate renal and/or liver function * known positive hiv test * previously suspected of or confirmed to have neutralizing antibodies to rhuepo * received more than 2 red blood cell (rbc) transfusions within 4 weeks before randomization or any rbc transfusion within 14 days before randomization, or any planned rbc transfusion between randomization and study day 1 * received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1 * other investigational procedures * subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority * pregnant or breast feeding * not using adequate contraceptive precautions * known sensitivity to any of the products to be administered during dosing * previously randomized in this study * concerns for subject's compliance with protocol procedures

Keywords: non-myeloid malignancy darbepoetin alfa clinical trial
reference values and determinants of hydration in children 3-13 y

Conditions: Dehydration

Summary: purpose: 1. develop reference values for hydration biomarkers for children of 3 to 13 years old 2. explore the association between children's and parents' hydration markers and fluid intake habits in children aged 3-13 y 3. evaluate the equivalence of spot urine osmolality to 24h urine osmolality in children aged 3-13 y 4. evaluate the differences in hydration markers between school and non-school days in children aged 3-13 y 5. examine the role of different foods and fluids on hydration in children (3-13 y) and parents

recent studies in children have indicated that greater water intake and/or lower urine concentration are associated with better overall nutrition, increased physical activity, improved mood state, and enhanced cognition; which is specifically related to superior attention and memory when compared to sub-optimally hydrated children. separately, ancillary water is being investigated as a potential treatment possibility for pediatric obesity. although, causality cannot be directly confirmed, it is apparent that ample water intake in children, above and beyond the body's compensatory mechanisms, is preferable for psychological and physiological health. however, the prevalence of failure to meet water recommendations and hypohydration in children remains high. still it is unclear if elevated hypohydration reports within the pediatric population are due to a general failure of children to meet water recommendations, or due to inadequacy of the published guidelines

Eligibility criteria:
inclusion criteria: * boys and girls aged 3-13 years old * parent willing to participate as a subject as well * parents: aged 20-50 * children and parents willing to collect urine samples and store them at room temperature * avoid strenuous exercise on day of collection * parent: included if \>50% of grocery shopping, food preparation, and feeding is handled by this parent exclusion criteria: parents \& children: * evidence of clinically relevant metabolic, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrine or psychiatric history of disease, based on the medical history questionnaire * use of medication that interferes with water metabolism * surgical operation on digestive tract (e.g. bariatric surgery), except possible appendectomy * regular drug treatment within 15 days prior to start of the study * not willing to refrain from exercise on the day before and during urine collection * unwilling to collect urine * inability to participate in the entire study * pregnancy for females children: * use of diapers * enuresis or use of nappies during the day or during the night

Keywords: urine biomarkers child nutrition hydration parent nutrition habits
the rob-ostial study

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (pci) using the corpath grx® system, versus standard pci when treating ostial lesions. corpath grx system (the device) is a robotic-like device that is cleared for the remote delivery and control of heart catheterization devices. it helps doctors insert and move heart catheters (a thin, flexible tube) and similar types of devices inside patients blood vessels to treat the blockage in their heart. the results will help to evaluate whether procedures using the corpath grx result in more accurate stenting (placing of a tube to keep heart vessel open) compared to standard pci.

to assess accuracy of robotic-assisted pci in obtaining full ostial lesion coverage and minimal protrusion compared to standard pci. robotically assisted pci offers the opportunity of performing minimal device movements (up to a minimum of 1 mm) in a stable and reproducible setting. this feature may be of great help when dealing with ostial lesions, whose treatment requires a precise stent positioning to avoid strut protrusion but also geographic miss of the lesion. robotic-assisted pci for ostial lesions showed encouraging results in large observational registries, but no study compared this approach with standard pci. the aim is to perform a randomized (1:1) study comparing standard (n=33) and robotic-assisted pci (n=33) in obtaining full lesion coverage when treating ostial lesions (ostial left main will be excluded). primary endpoint of the study will be full ostial coverage as assessed by ivus imaging, while secondary endpoints will be procedural success, vessel damage and number of protruding struts in the donor vessel as assessed by ivus imaging.

Eligibility criteria:
inclusion criteria: * male or nonpregnant female aged ≥18 years * coronary ostial lesion suitable for percutaneous coronary intervention (pci) * the subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. exclusion criteria: * cardiogenic shock or hemodynamic instability requiring support. * st-elevation myocardial infarction. * ongoing acute renal failure. * in the opinion of the investigator, the subject is deemed unsuitable for robotic pci due to clinical status and/or anatomic characteristics * more than one lesion to be treated * ostial left main disease

Keywords: ostial lesion robotic-assisted pci pci
a study of sgb-9768 in patients with complement-mediated kidney diseases

Conditions: IgA Nephropathy (IgAN); C3 Glomerulopathy; IC-MPGN

Summary: this study looks at how well and safely sgb-9768 works for patients with certain kidney diseases: primary iga nephropathy, c3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis. it's a phase 2 trial done at several locations where both patients and doctors know what treatment is being given.

this is a phase 2, multicenter, open-label study to evaluate of the efficacy and safety of sgb-9768 in patients with primary iga nephropathy, c3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis. the primary objective is to evaluate efficacy of sgb-9768 in reducing urine protein excretion and maintain kidney function in these patients. secondly, safety, pharmacokinetics and pharmacodynamics will be charaterized.

Eligibility criteria:
inclusion criteria: * aged ≥18 years * weight ≥40 kg, with a body mass index (bmi) between 15 and 35 kg/m² * biopsy-confirmed diagnosis of primary iga nephropathy, c3 glomerulopathy or ic-mpgn, accompanied by c3 deposition in the glomeruli. * urine protein-to-creatinine ratio (upcr) ≥0.75 g/g * estimated glomerular filtration rate (egfr) (calculated using the ckd-epi formula) must be ≥30 ml/min/1.73 m². * must be on a stable maximum tolerated doses of ace inhibitors (acei) or angiotensin receptor blockers (arb) for at least 12 weeks * participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug exclusion criteria: * kidney biopsy indicates more than 50% tubular atrophy or interstitial fibrosis. * kidney biopsy shows more than 50% formation of glomerular crescents, or clinical signs suggestive of rapidly progressive glomerulonephritis. * iga nephropathy, c3 glomerulopathy, or ic-mpgn secondary to other diseases * presence of other systemic diseases or kidney diseases that may cause proteinuria * received immunosuppressants or other immunomodulators within 90 days prior to the first administration of the investigational drug * received b-cell targeted biologics or other biologics within 180 days prior to the first administration of the investigational drug * used sglt2 inhibitors or endothelin receptor antagonists, unless have been stably used for 12 weeks or more * significant comorbidities * history of any malignant tumors of any organ system within the past 5 years * history of severe trauma or major surgery within 12 weeks prior to screening, or plans to undergo surgery during the study. * history of immunodeficiency diseases, congenital asplenia or splenectomy. * history of recurrent invasive infections, active systemic bacterial, viral, or fungal infections * positive test results for hbv, hcv, hiv * alanine aminotransferase (alt) or aspartate aminotransferase (ast) levels \> 2.5 times the upper limit of normal (uln)