Kornimate/medical-research-clean huggingface dataset:
the effect of bevacizumab and ziv-aflibercept in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: in this double clinical trial 132 patient with the history of dme (diabetic macular edema) to receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) . the study drugs were administered as often as every 4 weeks for 3 months.monitoring of best-corrected visual acuity, cst ( central subfield thickness) by oct (optical coherence tomography) was done from base line ,4 weeks, 8weeks after injection.


Eligibility criteria:
inclusion criteria: * the patient at least 18 years old had type 1 or 2 diabetes who presented with central dme involvement (defined as retinal thickening involving 1mm central sub field thickness(cct) * have at least a bcva ( best corrected visual acuity) between 20/50 to 20/320 snellen equivalent * have received to anti-vegf( anti -vascular endothelial growth factor) and laser treatment within the previous 3 months exclusion criteria: * uncontrolled glaucoma/uncontrolled diabet , high risk prp(pan-retinal photocoagulation), one eye * prior treatment with intravitreal or peribulbar injection and laser therapy during the last 3 months * substantial cataract, history of uveitis * macular edema due to a cause other than dme * vmt(vitreomacular traction ) and erm (epiretinal membrane)
radiotherapy with or without concurrent chemotherapy for extensive lymphatic metastasis of esophageal cancer - 3jecrog p-03

Conditions: IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer

Summary: the investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.


Eligibility criteria:
inclusion criteria: * age\<70 * diagnosis of clinical stage t2-4n0-1m1（according to uicc 2002） * a untreated squamous esophageal carcinoma * karnofsky performance status(kps)≥ 70 and charlson score ≤3 * adequate organ function * no known history of drug allergy * blood routine examination : wbc≥4.0 * hepatic and renal function are normal exclusion criteria: * age≥ 70 or ≤ 16 * already received the treatment of chemotherapy or radiotherapy * pregnant or lactating females * known drug allergy * without agreement of informed consent form * insufficient hepatorenal function or blood routine examination * severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
clinical audit of cardio pulmonary resuscitation management in adults patient units of care by in situ simulation

Conditions: in Hospital Cardiac Arrest; in Situ Simulation; Clinical Audit; Education

Summary: clinical audit of in-hospital cardiac arrest management by in situ simulation objectives: correct latent safety threats, knowledge gap, and crisis resource management (crm) design: clinical audit, observational sudy. primary outcome: in hospital resuscitation scale. exploratory outcomes: non technical skills, validated stress inventory, and questionnaire on perceptions of the simulation and organisational changes needed.


Eligibility criteria:
inclusion criteria: * team members: nurses, auxiliary nurses, residents, doctors, students exclusion criteria: * non volunteers

Keywords: in hospital cardiac arrest in situ simulation clinical audit education
satisfaction survey - cicaplast mains

Conditions: Hand Eczema; Hand Dermatoses

Summary: the participants presenting with hand problems and meeting the inclusion criteria are asked to apply the study product for one month. they are evaluated before and after treatment.

the international, open, observational survey is conducted in 3 different countries. regarding the statistical analysis, the global satisfaction is described in 5 classes and in 2 classes "satisfied + very satisfied" vs. "neither satisfied nor dissatisfied + not so satisfied + not at all satisfied". the 95% confidence interval (ci) of the percent of "satisfied + very satisfied" is also given. on patients who already used cream at the inclusion, the following analyses are performed: * cross-tabulation between both visits, * test of the evolution between both visits using a special procedure for ordinal data with repeated measures, * description of a summary variable in 3 classes (improved / no change / worsened). for the analysis of the hands problems, each sign is described at the inclusion and at the evaluation visit. the difference evaluation-inclusion is also given. the evolution of the sign is performed by a wilcoxon test for matched samples.

Eligibility criteria:
inclusion criteria: * professionals that work on different activities related to hair in a beauty salon * professionals presenting with current hand problems such as dryness, redness, irritations, cracks and fissures exclusion criteria: - professionals that do not meet the inclusion criteria
effect of intradialytic parenteral nutrition on morbidity and mortality of malnourished hemodialysis patients

Conditions: Hemodialysis; Malnutrition

Summary: idpn is widely used in hd patients without clue of its effectiveness. study objectives: to evaluate idpn effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, karnofsky score

idpn is widely used in hd patients without clue of its effectiveness. study objectives: to evaluate idpn effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, karnofsky score. patient eligibility: adult patients ≤ 82 y with hd vintage \> 6 mo. and 2 of the following malnutrition criteria: bmi ≤ 20 kg/m2, bw loss/6 mo. ≥ 10%, serum albumin ≤ 35 g/l, prealbumin ≤ 300 mg/l. recruitment: patients in 38 hd units from january 2001 to december 2002 study protocol. patients are randomized into 2 groups: idpn group, given idpn during one year, and control group. for ethical reasons, the 2 groups are given oral supplementation during the same period. follow-up: two years after start of nutritional therapy. study end: december 31, 2004. final results will be available in early 2005.

Eligibility criteria:
inclusion criteria: * age between 18 and 82 years * hemodialysis vintage more than 6 months * two of the following markers of malnutrition: * body mass index (bmi) \<= 20 kg/m2 * body weight loss within 6 months \>= 10 percent * serum albumin \<= 35 g/l * prealbumin \<= 300 mg/l exclusion criteria: * weekly dialysis time \< 12 h * urea kt/v index \< 1.2 * serum albumin \> 38 g/l * prealbumin \> 330 mg/l * hypertriglyceridemia \> 2.5 mmol/l * associated comorbidities compromising the one-year survival * treatment by oral, enteral or parenteral feeding during the last 3 months * hospitalization at time of randomization

Keywords: hemodialysis intradialytic parenteral nutrition oral supplementation survival hospitalization serum albumin prealbumin transthyretin
study efficacy of enhancing cognitive reserve in patients with a first bipolar episode

Conditions: Bipolar Disorder

Summary: this study aims to adapt and apply a psychological program aimed at improving cognitive reserve (cr) in bipolar patients who have recently presented a first episode of the illness. the purpose of this project is to test both the effectiveness of the psychological intervention as well as the stability of the obtained results after nine months of follow-up. one-hundred and twenty patients (60 patients each centre) will be recruited and assessed with clinical, functioning, quality of life, neuropsychological and rc assessment tools. then, participants will be randomly assigned to two different conditions: the experimental one, consisting in the implementation of the psychological intervention aiming at improving cr (n=60), and the control one, in which the usual pharmacological treatment will be carried on (n=60). once the psychological intervention has finished (3 months) re-assessment of all the explored variables at baseline will be performed. finally, after 12 months from the baseline visit, a re-assessment of all the participants in the study will be carried out to verify that post-intervention obtained results remain stable throughout the complete follow-up period. the investigators hypothesized that patients with a recent first episode who have undergone the intervention program will improve their cr as well as measures related to the severity of the difficulties observed at baseline concerning clinical, functioning, quality of life and neurocognitive performance. a second hypotheses is that all these changes will remain stable after nine month follow-up.


Eligibility criteria:
inclusion criteria: * patients between 18 and 40 years of age whose disease onset (first episode) is within the last 5 years. * fulfill diagnostic criteria for bipolar disorder (type i or type ii) or schizoaffective disorder, bipolar type, according to the diagnostic and statistical manual of mental disorders of the american psychiatric association (dsm-5) based on a semi-structured clinical interview. * patients in clinical remission or partial remission at the time of assessment, defined as scores ≤ 10 on the young mania rating scale (ymrs) (young, 1978) and ≤ 14 points on the hamilton depression rating scale (hamd) (hamilton, 1960). * signed informed consent to participate in the study. exclusion criteria: * estimated iq less than 85. * any medical condition that may affect neuropsychological performance (such as neurological diseases). * presence of any comorbid psychiatric condition (except substance use/abuse). * patients who have received any type of psychological intervention in the 6 months prior to the study.

Keywords: cognitive reserve
erythroferrone and its impact on maternal and neonatal iron homeostasis

Conditions: Pregnancy Anemia; Newborn; Anemia

Summary: erythroferrone (erfe) is a recently identified iron-regulatory hormone that couples iron homeostasis to erythropoiesis but at this time there are no human data on this hormone in pregnant women and their neonates. the investigators hypothesize that erfe is a sensitive biomarker of iron deficiency and anemia in pregnancy and neonates, and that it mediates the feedback mechanism to correct iron deficiency and anemia. to address this research gap, the investigators will measure erfe in maternal serum, umbilical cord serum and placental tissue using an existing biospecimen archive.


Eligibility criteria:
inclusion criteria: * healthy pregnant volunteers exclusion criteria: * hemoglobinopathies * pre-existing diabetes * malabsorption diseases * pregnancy induced hypertension * elevated diastolic blood pressure (\>110) * previous treatment for lead exposure or elevated childhood lead concentrations. * preexisting medical conditions known to impact iron homeostasis
myeloid to adipocyte transdifferentiation in human cells

Conditions: Obesity

Summary: in order to design new programs to help prevent weight gain, promote successful and sustainable weight loss, and help treat diseases related to obesity, the investigators need a better understanding of why accumulating fat in certain regions of the body is bad for health. it is known that not all fat cells are the same, but it was recently discovered that some fat cells may arise from stem cells that come from the bone marrow (bone marrow progenitors), a previously unrecognized origin. this discovery has been paradigm shifting, because dogma has long held that all white fat cells arise from fat tissue resident mesenchymal stem cells. this is also important because fat cells arising from the bone marrow lineage may be linked to worse health outcomes. the aim of this study is to determine if cells that were not previously believed to contribute to fat generation in humans are indeed capable of becoming fat cells. to answer this question the investigators will take samples of cells from the blood and the fat tissue of younger and older men and women, isolate the cells that came from the bone marrow and grow them in culture to determine if they will turn into fat cells. the results of this investigation may reveal potential mechanistic targets for future therapies to reduce the negative health outcomes associated with obesity related chronic diseases.


Eligibility criteria:
inclusion criteria: * men and women age 21-40 y or 55-100 y; * older women will be postmenopausal who are at least 12 months past the final menstrual period (fmp); * young women will be premenopausal and eumenorrheic, not on hormonal contraceptive therapy; * body mass index (bmi) 22-35 kg/m2; * non-active to moderately active (vigorous exercise ≤ 3 days/wk lasting \< 30 min). exclusion criteria: * immunosuppression therapy; * on blood thinners, aspirin, or nsaids that cannot be withheld for the biopsy; * prior history of allergies to local anesthetics; * current use of hormones, or glucose lowering medication; * currently engaged in a vigorous exercise or diet program; * currently gaining or losing weight or using weight loss drugs; * type 2 diabetes (past/current diagnosis or treatment); * diagnosis of uncontrolled metabolic disorders (e.g., thyroid); * history of severe obesity bmi ≥ 40 or significant weight loss (≥ 50 lbs); * postmenopausal - hormonal menopausal therapy use currently or in the previous 6 months; * premenopausal - irregular menstrual cycles defined as 2 or more missed cycles in the previous year, pregnant or planning to become pregnant during the study timeline (urine pregnancy test will be performed before dexa \[dual energy x-ray absorptiometry\] scan is completed).
failure analysis of patellofemoral arthroplasty

Conditions: Patellofemoral Osteoarthritis; Arthroplasty Complications; Knee Osteoarthritis

Summary: the purpose of the retrospective cohort study is 1) to determine preoperative risk factors for revision af patellofemoral arthroplasty, and 2) to provide a detailed description of indications for revision after patellofemoral arthroplasty. all patients operated with patellofemoral arthroplasty in denmark from january 1, 2008 to december 31, 2015, will be included in the cohort.

approx. 11,000 operations with the insertion of a knee arthroplasty (knee prosthesis) are performed annually dk. the durability and quality of the treatment are assessed with prosthesis survival, that expresses the proportion of prostheses that are still functional after a given number of years (eg the 10-year prosthesis survival for all types of knee prostheses in dk is approximately 94%). unicompartmental implants are increasingly used, so that only the worn part of the knee is replaced. especially for osteoarthritis between the patella and the femur, a patellofemoral prosthesis (pfa - patellofemoral alloplasty) can be inserted, which is much smaller than the traditional full prosthesis (tka - total knee arthroplasty). pfa operations are controversial. a recently published danish study (double-blind rct) comparing tka and pfa has shown that pfa patients achieve greater satisfaction, better knee function and greater quality of life than tka patients. a recent study has also demonstrated that the cost of a pfa procedure is less than that of a tka. as a paradox to this clear rct finding, all national implant registers (sweden, england, new zealand, denmark, etc.) show a significantly poorer prosthesis survival for pfa compared with tka. it is important for the future treatment of patients with severe osteoarthritis between the patella and femur to understand the cause of the discrepancy between rct and registry results. the discrepancy gives rise to a number of questions regarding. indications, techniques, competences, postoperative regimens etc. the divergence between the rct and registry studies can only be clarified by a study that 1) examines the influence of preperative factors (patient history, physical findings, radiology etc.) on outcome, and that 2) attempts a causal analysis for each reoperation. the investigators intend to do this though a cohort study including all cases of patellofemoral arthroplasty performed in denmark from january 1, 2008 until december 31, 2015. the purpose is to determine preoperative risk factors for revision after pfa and to provide a detailed description of indications for revision after pfa.

Eligibility criteria:
inclusion criteria: * patellofemoral arthroplasty * primary procedure performed between jan 1 2008 and dec 31 2015 * primary procedure performed in denmark exclusion criteria: * patella-nail syndrome * dislocating tendon following patellectomy.

Keywords: patellofemoral arthroplasty knee revision surgery indication
study of safety and efficacy of ceritinib in combination with nivolumab in patients with alk-positive non-small cell lung cancer

Conditions: ALK-positive NSCLC

Summary: this is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in alk-positive nsclc patients


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of nsclc that carries an alk rearrangement * stage iiib or iv nsclc or relapsed locally advanced or metastatic nsclc * presence of at least one measurable lesion as defined by recist 1.1 * patients who have received prior chemotherapy, other alk inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ≤1 (ctcae v 4.03). patients with grade ≤ 2 peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes are allowed to enter the study * patient has a who performance status 0-1 exclusion criteria: * presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years * patients with an active, known or suspected autoimmune disease * unable or unwilling to swallow tablets or capsules * patient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results

Keywords: nsclc, alk-positive
tyrosine allergoid paediatric and adult study

Conditions: Allergic Rhinitis Due to Pollen; Allergic Conjunctivitis; Allergic Asthma

Summary: the primary objective of this 5-year study is to demonstrate non-inferiority of children compared to adults by exploring long-term effectiveness after treatment with ta bäume (trees) and ta gräser (grass) following a perennial posology.


Eligibility criteria:
inclusion criteria: * patients from 5 years of age who are treated with ta gräser top or ta bäume top due to rhinitis, conjunctivitis and/or mild to moderate bronchial asthma, which are caused by an ige-mediated allergy to grass and rye pollen or birch, alder and hazel pollen according to the respective smpc. * patients will only be included in this study after the decision on the treatment has been made. exclusion criteria: * history of allergen-specific immunotherapy (sit) for trees or grass within the last 5 years * if it´s intended to treat the patient with only a preseasonal therapy * a patient should also not be included in the presence of any of the conditions listed in the respective smpc

Keywords: allergy
study of uveitic macular edema treated with ranibizumab or steroids

Conditions: Macular Edema; Uveitis

Summary: this is a pilot study to investigate the safety and efficacy of intravitreally administered ranibizumab (lucentis) compared to steroid injection for the treatment of macular edema due to chronic non-infectious uveitis. there is currently no fda-approved therapy for this condition, however intravitreal injection of corticosteroids, in conjunction with oral steroids and/or immunomodulatory drug agents, has become the mainstay of therapy. ranibizumab is a recombinant monoclonal antibody antigen-binding fragment that neutralizes the active forms of vascular endothelial growth factor (vegf), which is believed to contribute to the etiology of inflammation and neovascularization. ranibizumab is fda-approved for the treatment of neovascular age-related macular degeneration.

this is a proof of concept study to assess the safety and potential efficacy of ranibizumab in this patient population. since it is common clinical practice to perform regional periocular injections of steroids in patients with uveitic macular edema, only patients who are refractory to periocular steroids will be enrolled in the study. the 0.5 mg dose of ranibizumab will be given intravitreally since this dose and route has been found to be safe and efficacious in prior studies. a dosing regimen has not been established for ranibizumab in patients with uveitis, so patients will be assessed and treated monthly as needed. triamcinolone 4mg intravitreal injection will be the steroid treatment, and patients will also be assessed monthly and retreated every three months as needed.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * history of non-infectious uveitis w chronic cystoid macular edema * refractory to therapy w periocular steroids; last periocular steroid injection a minimum of 3 months prior to study enrollment * currently using oral steroids (\< or = 10 mg/day) and/or steroid sparing agents * bcva between 20/40 and 20/400 * iop between 5 mmhg and 30 mmhg * media clarity sufficient for oct measurement exclusion criteria: * women known to be pregnant or have a positive urine pregnancy test; pre-menopausal women not using adequate contraception during the study * prior treatment for cme with macugen or avastin in the study eye * history of stroke * presence of vitreous hemorrhage or epiretinal membrane in the study eye * active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye * presence or history of uncontrolled glaucoma * known allergy or hypersensitivity to any component of the study drug * major surgery planned during the next 6 months * simultaneous participation in another clinical investigation

Keywords: biomedical research macular edema uveitis ranibizumab steroids