Kornimate/medical-research-clean huggingface dataset:
comparison of two diagnostic tests in patients with suspected invasive candidiasis in internal medicine wards and who are currently timely treated with micafungin

Conditions: Invasive Candidiasis

Summary: epica-1 is a multicenter, open label, interventional study which will involve about 30 internal medicine units throughout italy, enrolling globally at least 100 hospitalised patients with suspicion of invasive candidiasis. these patients will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-d-glucan test: this will allow collection of information on patients outcome. at the same time, patients will be also evaluated by means of blood culture, so that comparison will be possible between the two diagnostic tests (primary end-point of the study).


Eligibility criteria:
inclusion criteria: * age 18 years * patients giving their informed consent to participate to the study and to the use of their health data * patients with two or more sirs criteria (hyperthermia, or hypothermia, tachycardia, tachypnea, leucocytosis or leukopenia ) * patients treated with antibiotic therapy in the last 4 weeks and with central venous catheter * patients with at least one of these conditions ( cortisone therapy/ immunosuppressive agents, total parenteral nutrition, urinary catheter, anticancer chemotherapy and major surgery in the last 3 weeks, acute pancreatitis, diabetes mellitus, liver diseases, dialysis) exclusion criteria: * patients with alt, ast, bilirubin \> 3 times the upper limit of normal * patients enrolled in other interventional clinical studies * patients treated with echinocandin or azolic or polyene at the time of the enrolment * pregnancy or breastfeeding * neutropenic patients * hiv positive patients * central nervous system events
a study to evaluate the safety and immunogenicity of rsvpref coadministered with herpes zoster vaccine in adults

Conditions: Respiratory Syncytial Virus (RSV)

Summary: this purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of rsvpref and hz/su vaccine when given together in adults 50 years of age and older.


Eligibility criteria:
inclusion criteria • male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions exclusion criteria * current clinically suspected or polymerase chain reaction (pcr)-confirmed ongoing episode of hz and/or history of clinically suspected or pcr-confirmed hz within the past 12 months. * prior history of any subtype of guillain barré syndrome of any etiology. * serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study. * immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, and medication list * previous vaccination with any licensed or investigational rsv vaccine at any time prior to enrollment, or planned receipt of a nonstudy rsv vaccine during study participation. * previous vaccination with any licensed recombinant adjuvant zoster vaccine (shingrix) at any time prior to enrollment, or planned receipt of a nonstudy licensed vzv vaccine (shingrix) during study participation. * history of previous vaccination with live hz vaccine (zostavax) in the last 2 years from enrollment, or planned receipt through study participation. * previous vaccination with any investigational vzv vaccine at any time prior to enrollment, or planned receipt of a nonstudy investigational vzv vaccine during study participation. * individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids (defined as ≥20 mg/day of prednisone or equivalent for ≥14 days), eg, for cancer or an autoimmune disease, or radiotherapy, from 60 days before study intervention administration, or planned receipt throughout the study.

Keywords: rsv vaccine
the evaluation of balance control by quantification of temporospatial measures while forward and side reaching

Conditions: Brain Injury

Summary: balance control is the sum action of the sense and reaction systems. in order to perform different activities in different postures one must have the ability to control and to adjust his balance in different conditions.a deficit in brain action following injury, disease or aging can undermine the ability to control balance and increase the risk to fall.the limitation in gait and mobility can increase morbidity. there is a limited number of tools evaluating and recording balance control ability. most of this tools are observational and can be used in the clinical field. the aim of this work is to estimate the feasibility of an objective tool that can evaluate balance by tracking objective quantitative measures during the standard physical therapy session without using an expensive equipment. by using this tool the therapist can monitor the patient and collect quantitive data while performing tasks while keeping balance. this tool will allow the therapist to detect changes in balance and evaluate the effect of different conditions on the patients balance. this tool is based on the well known functional reach test. the addition of this tool to the test is the use of a simple camera and a computer softwear that will collect the data and analyze it while performing the test. this tool will give the therapist information on the responsiveness and the spatiotemporal measures of the performance. the aim of this work is to check what is the contribution of spatiotemporal measures of the functional reach test among patients suffering from acquired brain injury to the understanding of the motor function and balance control of people suffering from brain injury. .


Eligibility criteria:
inclusion criteria: * acquired brain injury patients can stand without assistance for at list 10 sec. can walk 10m with or without walking aid has no limitation in rpom of the upper or lower limb need no guardian exclusion criteria: * apraxia of all kind aphasia neglect

Keywords: acquired brain injury balance control functional reach
an observational study on incidence, natural history and treatment patterns of venous thromboembolism in taiwan

Conditions: Venous Thromboembolism

Summary: the research question addressed by this study is primarily on the clinical epidemiology of vte in taiwan. the study aims to estimate the incidence of vte and describe natural history of vte, including long term clinical outcomes in adult taiwanese population, utilizing population-based electronic health data in taiwan.


Eligibility criteria:
inclusion criteria: * the source population was the adult population in taiwan. the legal age for definition as an adult (without additional research ethics review requirement) in taiwan is 20; therefore all national health insurance (nhi) enrollees age 20 or older at any time during the study period were evaluated for vte. exclusion criteria: * person-time before an eligible subject turned 20 were not evaluated. * study subjects having inconsistent data on gender and unrealistic date of birth (birth year before 1890 and after 2015) were identified and excluded from the analysis.
high-dose sequential chemoimmunotherapy for b-cell lymphomas with central nervous system involvement

Conditions: B-cell Lymphomas

Summary: this prospective trial will assess the activity and feasibility of a new high-dose methotrexate-based high-dose sequential chemotherapy combination in patients with b-cell lymphomas and cns involvement at diagnosis or relapse. selected drugs, with a well-documented anti-lymphoma activity, will be administered at high doses to increase blood-brain barrier penetration and cns bioavailability as well as to reduce potential cross-resistance.

patients with aggressive b-cell lymphoma and involvement of the central nervous system at diagnosis or relapse will be treated with a combination of high-dose methotrexate and high-dose cytarabine, rituximab, and intrathecal depocyte followed by rituximab-high-dose sequential chemotherapy supported by autologous tsem cell transplantation.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of diffuse large-cell, follicular or mantle cell lymphoma 2. cns involvement (brain, meninges, cranial nerves, eyes, and/or spinal cord) at diagnosis or relapse after conventional chemotherapy 3. diagnosis of cns involvement either by brain biopsy or csf cytology examination. neuroimaging alone is acceptable only when stereotactic biopsy is formally contraindicated. 4. age 18-70 years 5. ecog performance status 0-3 6. adequate bone marrow (plt \> 100000 mm3, hb \> 9 g/dl, anc \> 2.000 mm3), renal (creatinine clearance \> 60 ml/min), cardiac (vef \> 50%), and hepatic function (total serum bilirubin \< 3 mg/dl, ast/alt and gammagt \< 2.5 per upper normal limit value), within 1 week prior to study start (unless the abnormality is due to lymphoma involvement) 7. absence of symptomatic coronary artery disease, cardiac arrhythmias not well controlled with medication or myocardial infarction within the last 6 months (new york heart association class iii or iv heart disease) 8. absence of hiv infection 9. no previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix and carcinoma of the skin and of other cancers without evidence of disease at least from 5 years 10. absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 11. female patients must be non-pregnant and non-lactating. sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation 12. no treatment with other experimental drugs within the 6 weeks previous to enrolment 13. give written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice exclusion criteria: * na

Keywords: b-cell lymphomas lymphomatous meningitis liposomal cytarabine autologous transplant cns involvement secondary cns lymphomas
actigraphy to measure intensive care unit activity

Conditions: Disability; Physical Activity; Aging; Critical Illness

Summary: this study is to determine whether accelerometry can be used to measure physical activity occurring during routine clinical care in a diverse population of patients with medical or surgical critical illness.

patients that meet inclusion criteria will have a wristwatch size, lightweight actigraph gt3x+ placed at each of three body sites, the dominant-side wrist, right hip and dominant-side ankle to objectively measure physical activity. patients will wear the actigraph devices during two 30-minute periods of direct observation. to compare activity counts measured by the actigraph devices with directly observed purposeful physical activity, we will record the time and type of physical activity performed by patients such as sitting at the edge of the bed, sitting in a bedside chair, transferring to a chair, standing and ambulating. the data acquired from this observational (amercia) study will seek to establish the feasibility of using accelerometers to measure activity in a diverse population of patients with medical or surgical critical illness.

Eligibility criteria:
inclusion criteria: patients will be included if they are: 1. adult patients, 2. admitted to the medical or surgical icu, 3. receiving or have received invasive or non-invasive mechanical ventilation for respiratory failure or vasopressors for shock (i.e., cardiogenic, hemorrhagic, septic or undifferentiated shock) within the last 48 hours, and 4. who are receiving routine physical and occupational therapy. exclusion criteria: patients will be excluded if they meet any of the following criteria: 1. those who have severe physical disability that prevented independent living prior to their illness, 2. those unable to speak and communicate in english, 3. expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by the family or medical team (i.e., likely to withdraw life support measures within 24 hours of screening), 4. inability to obtain informed consent from authorized surrogate;

Keywords: physical activity intensive care activities of daily living delirium sepsis mechanical ventilation critical care critical illness aging accelerometery
the effect of low-level laser stimulation on hearing thresholds

Conditions: Hearing Loss

Summary: the purpose of this study is to determine whether low-level laser therapy can improve hearing thresholds in individuals with hearing loss. subjects will be randomly assigned to a treatment, placebo, or control group. the treatment group will be given a three treatment of low-level laser therapy, which consists of shining low-level lasers beams onto the ear and head. the laser beams are cool to the touch, and do not cause discomfort. each laser treatment will last approximately 4 minutes. three treatments will be applied three times within the course of one week. hearing tests will be administered immediately before treatment, immediately after treatment, and six weeks after treatment. results will be analyzed to determine the effect of the laser treatment on hearing.

low-level laser therapy has been practiced for about 20 years in europe and is beginning to be practiced in the us. theoretically, laser energy in the red and near infrared light spectrum is capable of penetrating 2-5 cm into tissue and can stimulate mitochondria in the cells to produce more energy (through the production of adenosine triphosphate), which in turn may help prevent or repair tissue damage. the effects of low-level laser therapy on hearing have not been well studied. it has been suggested that laser therapy might help repair damage to the cochlea and restore some degree of hearing loss. studies of low-level laser stimulation of cochleae utilizing microscopy, pet imaging, and mri suggest potential therapeutic benefit to hearing. while preliminary studies suggest a possible improvement in hearing thresholds, a carefully controlled study is needed to verify the results using a valid battery of audiological tests.

Eligibility criteria:
inclusion criteria: * bilateral sensorineural hearing loss * normal middle ear status exclusion criteria: * pregnant or lactating * serious mental health illness or medical/psychiatric hospitalization * treatment with cancer chemotherapeutic agents or aminoglycoside antibiotics * taking aspirin, ibuprofen, naprosyn, aleve * taking any quinine-related drugs * taking any loop diuretics * have a developmental disability or cognitive impairment * history of drug abuse * involved in litigation or claim related to hearing loss * regularly exposed to significant occupational or recreational noise * have a photosensitivity disorder * have a retinal disease

Keywords: hearing loss, bilateral hearing loss, sensorineural
treatment protocols for patients with symptomatic oral lichen planus

Conditions: Lichen Planus, Oral; Preneoplastic Condition

Summary: the primary objective of this study was to compare the therapeutic efficacy of clobetasol propionate 0.05% oral gel versus an anti-inflammatory mouthwash in an oral solution for the management of patients suffering from symptomatic olp. the secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects.

forty patients were assigned (20 patients per group), through a randomized design, to receive clobetasol (clobetasol gel 0.05%), or an anti-inflammatory mouthwash (mouthwash which contains calcium hydroxide, hyaluronic acid, umbelliferone and oligomeric proanthocyanidins) for 3-months. at baseline (t0) and after 3 months (t1), patients were subjected to clinical and oral assessments and were evaluated for the symptoms (numerical pain scale, nrs score) and signs (thongprasom's score) of olp. data were calculated using t-test for the dependent variable, wilcoxon test and mann-witney u test.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * clinical diagnosis and histological diagnosis of olp on the basis of who criteria; * presence of symptoms related to olp. exclusion criteria: * presence of systemic conditions that may have affected the study results; * state of pregnancy or breastfeeding; * histological signs of dysplasia; * drugs inducing a lichen response (ace-inhibitors, β-blockers, etc.); * treatment of olp in the six months prior to the start of the programme; * presence of extraoral lesions (genital, skin and other) * history of previous immunodeficiency or hiv seropositivity; * previous allogeneic bone marrow transplantation; * presence of systemic lupus erythematosus or other autoimmune diseases.
cos-p for parents of children referred to child psychiatric services

Conditions: Child Behavior Problem

Summary: background:the quality of attachment is greatly influenced by parental sensitivity. attachment based interventions are designed to promote parental sensitivity, to change parental mental representations and to improve understanding of the developmental needs of the child. very few studies have investigated the effect of attachment-based interventions on psychiatric symptoms in children. targeting parental sensitivity and the parent-child interaction might have an important impact on psychiatric symptoms in a clinical sample of children referred to child psychiatric services. objectives: the primary objective is to investigate whether circle of security-parenting (cos-p) has an effect on parental sensitivity in parents of children referred to child psychiatric services. the secondary objectives are to investigate the effect on children's behavioral and emotional symptoms and the parental stress and reflective functioning after 10 weeks of intervention and at the 24 week follow-up. the study is also exploring the effect of parental attachment style, parental stress and parental psychopathology on the effect of the intervention. methods: the trial will include 128 families of children (age 3-8 years) who are referred to child psychiatric services in a randomized and controlled design. included families will be randomized to cos-p+ treatment as usual (tau) or tau only. perspectives: considering the important impact of the quality of the parent-child relationship on the child's well-being, it is essential to target it in interventions and to investigate the relation with psychiatric symptoms. generally there is a lack of interventions targeting parental sensitivity in psychiatric child populations. working with the parents on the child-parent relation, might have an important impact on their children's current psychiatric symptoms and could additionally prevent future psychopathology.


Eligibility criteria:
inclusion criteria: * children who score equal or above the 93d percentile on cbcl-total score * score above 93d percentile on the cbcl- odd or aggression scale * informed consent from both custody. exclusion criteria: for children: * autism spectrum disorders * serious psychopathology requiring immediate clinical attention * head injury or verified neurological disease * intelligence quotient (iq) \<80 * medical condition, requiring treatment * no informed consent from custody for parents: * a diagnosis of schizophrenia * bipolar disorder * known substance abuse * severe intellectual impairment * suicide attempt in the past

Keywords: attachment parent training sensitivity
brain natriuretic peptide (bnp) usefulness in elderly dyspneic patients (bed)

Conditions: Heart Failure

Summary: the purpose of this study is to test the usefulness of measuring plasma brain natriuretic peptide (bnp) for diagnosis and prognosis in very elderly dyspneic patients.

measurement of bnp concentration is approved for use in the diagnosis of heart failure (hf) in elderly patients below 80 years of age. the value of plasma bnp assays as diagnostic tools has not been determined in very elderly populations because the plasma bnp increases with age. this large, multicenter, prospective, observational, study in 300 participants is aimed to prospectively test the usefulness of measuring plasma bnp for diagnosis of hf in dyspneic patients aged 80 and older.

Eligibility criteria:
inclusion criteria: * acute dyspnea * crackles on lung auscultation, * hypoxemia, * right-sided signs. exclusion criteria: * no exclusion criteria

Keywords: diagnosis and prognosis very elderly population heart failure brain natriuretic peptide observational prospective study older dyspneic patients aged 80
docetaxel in non small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: primary objective: * to compare the tumour response rate of combination chemotherapy irinotecan/cisplatin (ic) versus docetaxel/cisplatin (dc) in advanced nsclc patients who responded to 3 courses of docetaxel/cisplatin. secondary objectives : * to compare the time to progression after chemotherapy treatment between the ic and dc arms of treatment. * to compare the toxicity profile of the ic and dc arms of treatment.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven non-small cell lung carcinoma at first diagnosis. * stage iiib or iv disease. * tumour considered unresectable. * performance status karnofsky index \> 60% or who performance status \< or = 1. * previous therapy * chemotherapy: none. * previous radiation therapy: prior irradiation for nsclc is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal. * laboratory requirements: * hematology: * neutrophils ≥ 2.0 10\^9/l, * platelets ≥ 100 10\^9/l, * hemoglobin ≥ 10 g/dl. * hepatic function:total bilirubin \ 1.5 x unl associated with alkaline phosphatase \> 2.5 x unl are not eligible for the study. * renal function: creatinine \ 60 ml/min. exclusion criteria: * pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation. * known clinical brain or leptomeningeal involvement. * pre-existing motor or sensory neurotoxicity of a severity \> grade 1 by national cancer institute criteria. * other serious illness or medical condition: * congestive heart failure or unstable angina pectoris even if it is medically controlled. previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high risk uncontrolled arrhythmias. * history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent. * active uncontrolled infection. * peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids. * past or current history of neoplasm other than non-small cell lung cancer, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix. * concurrent treatment with prednisone (or equivalent) except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or unless chronic treatment (initiated \> 6 months prior to study entry) at low dose (\< 20 mg methylprednisolone or equivalent). * definite contraindications for the use of corticosteroids. * concurrent treatment with other experimental drugs. participation in another clinical trial with any investigational drug within 30 days prior to study entry. * concurrent treatment with any other anti-cancer therapy. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.