Kornimate/medical-research-clean huggingface dataset:
complement 2: blood donations to develop vaccines against infectious diseases

Conditions: Complement Mediated Bacterial Killing in Healthy Adults

Summary: we need human blood to understand the immune response to infection and to test promising new vaccines against infectious diseases in the laboratory. one test is called the serum bactericidal assay (or sba), which is measure of how effective antibodies are at killing certain bacteria and can be an important measure of how effective a new vaccine may be. the samples would be used in the laboratory analysis of clinical trials of vaccines used in adults and children, and some samples in pre-clinical (animal) experiments testing new vaccines before they enter human-stage testing. most people have some form of protection against most bacteria already, so not everyone is a suitable blood donor for this laboratory test. we therefore start by taking a small blood sample and test this one before asking for more blood if we found yours suitable for the work we do.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent for participation in the study * aged between 18 and 70 years * in good health as determined by medical history and clinical judgment of the investigators * able to attend the scheduled visits and to comply with all study procedures * if found to be a suitable complement that they are willing to be approached for further donations exclusion criteria: * body weight less than 50kgs * have any known or suspected impairment or alteration of immune function, resulting from, as examples:congenital or acquired immunodeficiency, receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy, receipt of immunoglobulin or any blood product transfusion within the last 3 months * female participants who are pregnant * any chronic illness that could, in the opinion of the investigators, interfere with immune function or with the donation of large volumes of blood (e.g. thrombocytopaenia or coagulopathy, malabsorption disorders, chronic anaemia) * an individual who is on the delegation log for the study * planned blood donation within 4 months of undergoing testing to assess whether the individual is a suitable complement donor

Keywords: complement serum bactericidal assay
study of grass-spire in subjects with grass allergies and asthma

Conditions: Seasonal Allergic Rhinitis; Asthma

Summary: the purpose of this study is to determine whether it is safe to administer grass-spire to subjects suffering from both grass allergy and asthma


Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 years. * asthma treated by inhaled saba or inhaled saba plus low-medium dose ics in 6 weeks prior to randomisation. * a reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to grass for at least the previous two grass seasons. * positive skin prick test to grass. * grass-specific immunoglobulin e (ige) ≥ 0.35 ku/l. exclusion criteria: * history of life-threatening asthma. * uncontrolled asthma according to gina. * fev1 of \<70 % of predicted, regardless of the cause. * administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease). * history of severe drug allergy or anaphylactic reaction to food. * a history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Keywords: grass allergy rhinoconjunctivitis rhinitis asthma
psychosexuological interventions to support sexual function in breast cancer patients

Conditions: Breast Cancer

Summary: prospective pilot study on the feasibility and efficacy of a brief psychosexual support intervention in breast cancer patients undergoing hormonal therapies for at least 6 months. the study is randomized in the two following arms: control arm (standard care pathway) psychosexual intervention arm

the aim of the study is to evaluate the effectiveness of a psychosexual intervention on sexual functioning, mood (levels of depression and anxiety), sleep, and quality of life, compared to standard care pathway. considering the high incidence of sexual dysfunction in breast cancer patients, this study will focus on this population of patients. the psychosexual intervention aims to improve female sexual functionality and satisfaction by facilitating the understanding of disorders, enabling adequate assessment of possible interventions, and adopting specific treatment exercises. patients will be randomized in one of the following two arms: control arm (standard care pathway) psychosexual intervention arm

Eligibility criteria:
inclusion criteria: * women with age \>=18 years; * breast cancer patients undergoing hormonal therapy for at least 6 months in accordance with clinical practice and scientific evidence; * pre-menopausal patients (regular menstrual cycles in the last year) before the start of oncological treatments; * presence of one or more criteria of sexual dysfunction as per dsm-5; * acceptance and signature of the informed consent. exclusion criteria: * patients in postmenopausal status; * presence of psychiatric or neurological conditions that impair the ability to perform the exercises proposed by the research project; * already undergoing psycho-sexual counseling; * refusal to sign the informed consent
treatment of rhinitis with intranasal vitamin e

Conditions: Rhinitis

Summary: many beneficial effects of vitamin e have been described, but vitamin e supplementation by mouth has not been effective in the treatment of nasal symptoms and allergic rhinitis. the investigators will evaluate the effect of vitamin e directly applied to the lining of the nose in individuals with moderate to severe rhinitis by symptom questionnaires.

vitamin e has health promoting properties that are attributed to its anti-oxidant action and its ability to stabilize cell membrane and promote restoration of the skin barrier function. the beneficial effects of the topical vitamin e applied to the skin have been firmly established and many skin care products now contain vitamin e, whereas the purported benefits cannot be achieved by oral intake of vitamin e. recently oral vitamin e was shown to be ineffective in the management of allergic rhinitis, which reminisces the clinical experience in dermatology. the failure of oral vitamin e could result from the relatively low local concentration that are not sufficient to scavenge the reactive oxygen species generated in the inflammatory process and restore the consequent epithelial damage to the nasal mucosa in rhinitis.the effect of topical vitamin e applied intranasally to the mucosa has never been studied. it stands to reason that higher local concentrations can be achieved by topical application of vitamin e directly to the nasal mucosa, which may confer the same positive effects observed with its direct application to the skin. we will perform a single center, prospective, randomized, double-blind, placebo-controlled, clinical trial to investigate the role of topical alpha-tocopherol in oil applied to the nasal mucosa 3 times per day with a q-tip on the subjective symptoms of rhinitis over the course of a 4-week period.

Eligibility criteria:
inclusion criteria: * clinical symptoms of rhinitis and symptom severity score of 25 or higher on the self-administered rhinosinusitis questionnaire (range of 0, i.e. absence of any symptom, to 50, which indicates the most severe symptom in each category) exclusion criteria: * inability to give informed consent, comprehend questions or instructions and complete questionnaires * recent change (within 2 weeks) in the medications that may affect nasal or sinus symptoms (intranasal or systemic glucocorticosteroids, mast cell stabilizer, antihistamines, decongestants, leukotriene antagonist, antibiotics, preparations containing thyroid or sex hormones, alpha-blocking agents) * intranasal use of oil- or gel-based products

Keywords: rhinitis vitamin e intranasal
a comparison of optimal peep determination guided by eit and conventional protective ventilation tool in ards patients

Conditions: ARDS; Acute Respiratory Distress Syndrome

Summary: the study of positive end-expiratory pressure(peep) in the setting mode has not yet been conclusive. there are several ways to choose the best positive end-expiratory pressure(peep) mode for ards patients. in this study ,the investigators selected two best positive end-expiratory pressure(peep) assessment methods to compare: first is using the conventional postive ventilator to choose positive end-expiratory pressure(peep) and the new non-invasive electrical impedance tomography(eit) guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. in this project, we utilize a newly available non-invasive method- electric impedance tomography (eit) and protective ventilation to determine the optimal peep on ards patients required invasive mechanical ventilator support at a medical center medical icu (micu) and cardiovascular icu (cvicu)- the far eastern memorial hospital, taiwan.

acute respiratory distress syndrome (ards)，over the years in the treatment policy has been confirmed that: with low tidal volume to achieve lung protection strategy and high positive end-expiratory pressure (peep), both can effectively reduce the mortality rate. and increase peep，the alveolar pressure is greater than the atmospheric pressure when exhaled，so that can be effective expansion of the lungs to avoid spitting at the end of the alveolar collapse. the study of peep in the setting mode has not yet been conclusive. currently in the clinical situation，there are several ways to choose the best peep mode for ards patients. in this study the investigators selected two best peep assessment methods to compare: first is using the conventional postive ventilator to choose optimal and the new non-invasive electrical impedance tomography guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. in this project, the investigators utilize a newly available non-invasive method- electric impedance tomography (eit) and protective ventilation to determine the optimal peep on ards patients required invasive mechanical ventilator support in icu at the far eastern memorial hospital, taiwan.

Eligibility criteria:
inclusion criteria: * moderate to severe ards patient on mechanical ventilation from er or word transfer icu. (p/f≦ 200 with peep ≥ 5cmh20) (peep greater than or equal to 5 cm h2o and berlin criteria for ards) exclusion criteria: * on pacemaker * pregnant * thoracic or spinal cord trauma * pneumothorax * hemodynamic instability * iicp

Keywords: ards acute respiratory distress syndrome peep pressure-volume loop positive end-expiratory pressure hysteresis
efficacy and safety of levocetirizine and fexofenadine in reducing symptoms of seasonal allergic rhinitis

Conditions: Rhinitis, Allergic, Seasonal

Summary: no information was yet available over the effect of levocetirizine in children under 12 years. the aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.


Eligibility criteria:
inclusion criteria: * adults 18 to 55 years both inclusive * suffering at least 2 years of seasonal allergic rhinitis due to grass pollen * positive rast and/or positive skin prick test * comply with study restrictions exclusion criteria: * known alcohol or drug addiction or abuse * known allergy/intolerance to lactose, cellulose, cornstarch * presence of nasal anatomical deformities leading to \> 50% obstruction * ent infection within 30 days of the study * use of disallowed medication * ongoing desensitization * known cardiac, renal or hepatic dysfunction * presenting allergic bronchial asthma * use of cimetidine * intending to donate blood during the trial

Keywords: levocetirizine dihydrochloride xyzal tablets
ischemic preconditioning and thiol-disulfide balance

Conditions: Tourniquets

Summary: various strategies have been proposed to prevent or mitigate the effects of ischemia-reperfusion injury following the use of tourniquets in orthopedic surgery cases. one of them is applying "remote ischemic preconditioning." this randomized controlled trial is planned to evaluate the effectiveness of remote ischemic preconditioning in preventing tourniquet-induced ischemia-reperfusion injury in total knee arthroscopy with dynamic thiol-disulfide homeostasis.


Eligibility criteria:
inclusion criteria: * asa i-iii patients who will undergo total knee arthroplasty surgery under elective conditions exclusion criteria: * emergency operation, * underlying neurological disorder, * underlying peripheral vascular disease, * other types of concurrent surgery.

Keywords: thiol/disulfide homeostasis ischemic preconditioning
nutritional education and the prevention of iron depletion in children 9 months to 2 years

Conditions: Iron Deficiency

Summary: iron depletion in young children is common and may progress to iron deficiency anemia which is associated with irreversible neurodevelopmental effects. efforts to prevent iron depletion are key to preventing these effects. in a recent study of 150 young children (12 to 38 months), we found that bottle fed children were almost three times as likely to be iron depleted compared with cup fed children (37% vs 18%). thus, we hypothesize that an educational intervention designed to encourage timely bottle weaning will lead to a reduction in iron depletion.

we plan to undertake a randomized controlled trial to evaluate the effectiveness of an office-based educational intervention for the prevention of iron depletion in young children. healthy children will be recruited from a community pediatric office which serves a diverse, urban population. children will be randomized to the intervention education group or the control education group at 9 months of age. blood work (\~4ml) for complete blood count and ferritin along with additional measures such as transferrin, iron, and reticulocyte count will be obtained at 24 months of age. rates of iron depletion and anemia will be compared in the two groups. the two groups will also have 25-hydroxy vitamin d, calcium and alkaline phosphatase levels analyzed at the 24 month visit to ensure that the intervention for prevention of iron depletion does not adversely affect these measures.

Eligibility criteria:
inclusion criteria: * children aged 9 months who are attending a routine primary care well-child visit. * children who are in good general health. * children whose parents provide informed consent to participate. exclusion criteria: * children with chronic illness. * children with birth weight less than 2.5 kg. * children with previously diagnosed anemia (including known iron deficiency anemia). this includes children with marrow failure (aplastic anemia, fanconi anemia), hemoglobinopathies (sickle cell disease, thalassemia), lead intoxication, sideroblastic anemia, megaloblastic anemia, enzymopathies (g6pd deficiency, pyruvate kinase deficiency), or membranopathies (hereditary spherocytosis). * children currently receiving medications associated with anemia. this includes children taking antimetabolites or phenytoin. * children currently receiving iron supplementation other than iron fortified formula.

Keywords: iron depletion children educational intervention office-based
bleeding risk in cvcs

Conditions: Bleeding

Summary: since many of the patients in an intensive care unit suffer from disorders of hemostasis, bleeding is a main concern applying central venous catheters. even if there are some data indicating elevated international normalized ratio may not increase the risk of bleeding no clear cut-off has been defined so far. an inr \> 1.5 is generally considered to increase the risk of bleeding. furthermore, many authors consider platelets below 50 x 109 /l as a contra-indication to cvc cannulation, since there are some data this may increase the risk of bleeding. therefore platelet transfusion before venous puncture is suggested. in our clinical experience inr \> 1.5 and platelets \< 50 x 109 /l do not correlate with increased risk of bleeding. the aim of this study is to demonstrate, that coagulopathy, defined by inr and platelet count, is not decisive for bleeding.


Eligibility criteria:
inclusion criteria: * all patients acquiring a central venous catheter exclusion criteria: * patients pre or post surgery * patients with bleeding due to other reason

Keywords: central venous catheter international normalized ratio thrombocytes bleeding risk all patients in need of central venous line comparison of patients with normal hemostasis to such with disorders in hemostasis
total 102 natural orifice specimen extractions following laparoscopic colorectal resections

Conditions: Incisional Hernia; Incision Infection

Summary: in the development of surgical technique, laparoscopic surgery has created a major breaking point. although laparoscopy (decreased hospital stay, decreased incisional hernia and wound infection rate...) provides a remarkable advantage compared to open surgery, the need for the extraction site incision could not bring the incision-related morbidity rates to the desired level. that's why sils and natural hole surgery came to the fore. colorectal surgery was also affected by this process, and the laparoscopic colectomy procedure combined with transrectal colon extraction was first performed in 1993 (1). although its use increased gradually after this period, it could not reach the expected levels and this could not resolve the concerns on natural hole surgery. in this article, our aim is to present the single center results of the patients who performed the extraction with the nose method after laparoscopic colorectal surgery.


Eligibility criteria:
inclusion criteria: * patients who underwent laparoscopic - natural orifice colectomy. exclusion criteria: * patients with missing data * patients who underwent open colectomy

Keywords: natural orifice surgery minimally invasive surgery colon cancer laparoscopic colorectal
early 3-months aggrenox treatment started within 24 hrs of ischemic stroke onset vs. after one week 100 mg asa

Conditions: Cerebrovascular Accident

Summary: german stroke units are hesitating to use aggrenox for secondary ischaemic stroke / transient ischaemic attack (tia) prevention in a sub-acute treatment setting. they argue that clinical experience with sub-acute aggrenox treatment is limited and poorly documented when compared with sub-acute acetylsalicylic acid (asa) treatment. however, long term treatment (started after 3-6 months after stroke/tia) with aggrenox was safe and superior to asa treatment in preventing recurrent strokes. there is no evidence for asa to prevent from neurological progression after stroke during the first 3 months. results from a cohort study suggest that starting aggrenox within 72 hours after stroke predicts clinical improvement in the national institute of health stroke scale (nihss) at discharge from the hospital. dipyridamole suppresses acute inflammatory responses to stroke. this study is designed to investigate the tolerability and efficacy of a secondary stroke prevention treatment with aggrenox when initiated within 24 hours of stroke onset on a stroke unit compared to later initiation after a 7 day asa treatment and outside off a stroke unit setting.


Eligibility criteria:
inclusion criteria: -clinical diagnosis of ischaemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. symptoms must be distinguishable from an episode of generalised ischaemia (i.e. syncope), seizure, or migraine disorder. main inclusion criteria: * patients at risk of stroke who have had transient ischaemia of the brain or completed ischaemic stroke due to thrombosis * symptoms of ischaemic attack began less than 24 hours prior to study medication start, are to be present for at least 30 minutes and have not significantly improved before start of treatment * patients are eligible for platelet inhibiting treatment * national institute of health stroke scale (nihss) between 5 and 20 (at pre-screening and screening) * actual modified rankin scale (mrs) (at baseline) is worse than retrospective mrs (before stroke) * a contraindication for stroke lysis is given * patients are able to give (at least oral) informed consent and to swallow either medication exclusion criteria: * hypersensitivity to any of the components of the product or salicylates. * patients with active gastric or duodenal ulcers or with bleeding disorders. * pregnancy during the third trimester. * lysis therapy. * a platelet inhibiting therapy with acetylsalicylic acid (asa) doses of more than 100 mg per day, or with clopidogrel of any dose has been planned or started. * time of onset of stroke symptoms is unknown (when a stroke happened during night-/sleeping time, bedtime is assumed as time of onset)
validation of prediction model of vitamin d deficiency

Conditions: Critical Illness

Summary: many studies have pointed out that patients with vitamin d deficiency have a longer stay in the intensive care unit and a poor prognosis. the investigators' previous multi-center prospective observational study in taiwan reveals that the prevalence of vitamin d deficiency in critically ill patients in northern taiwan is 59%, and the prevalence of severe vitamin d deficiency is 18%. the investigators used the data of that observational study to train a predictive model for predicting vitamin d deficiency. in addition, the association between vitamin d and the immune regulation of critically ill patients in taiwan has not been investigated. this study aims primarily to validate the performance of the prediction model of vitamin d deficiency. moreover, this study will investigate the association between vitamin d level and inflammatory cytokine levels. this multi-center prospective observational study will enroll critically ill patients admitted to intensive care units (icus) less than 28 days. after inform consent, blood will be drawn for examination of vitamin d, interleukin 6, and interleukin 10 levels. the main diagnosis of icu admission, past medical history, vital signs within 24 hours of admission, disease severity, and laboratory data will be recorded. the predictive model will use the required parameters to predict the patient's risk of vitamin d deficiency and vitamin d severe deficiency.


Eligibility criteria:
inclusion criteria: * patients admitted to intensive care units exclusion criteria: * aged \< 20 years * admitted to intensive care unit longer than 28 days * body max index \< 18 kg/m2 * receive vitamin d supplement \> 3000 iu/day * previously admitted to intensive care unit within 3 months * have parathyroid disease, rickets, or severe liver cirrhosis \[child c\]

Keywords: critical care vitamin d
internet delivered self-help for insomnia

Conditions: Insomnia

Summary: the current study aims to evaluate the effects of internet-delivered self-help cbt for insomnia through a randomised controlled trial. adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. participants will be randomised into treatment groups or the waiting list. participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.


Eligibility criteria:
inclusion criteria: * insomnia * access to the internet exclusion criteria: * alcohol or substance abuse * severe depression * being suicidal * sleep apnea * schizophrenic or having a psychosis disorder