Kornimate/medical-research-clean huggingface dataset:
micafungin prevention study for invasive fungal disease in pediatric & adolescent patients undergoing autologous hematopoietic stem cell transplantation

Conditions: Neutropenia; Fungal Disease

Summary: this study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. micafungin is administered until confirmation of neutrophil engraftment or treatment failure.

the purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (ifds) through the end of prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis after autologous hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. safety profile of micafungin is also evaluated.

Eligibility criteria:
inclusion criteria: 1. patients will receive autologous hematopoietic stem cell transplantation including 2nd autologous transplantation 2. under 21 years old, pediatric, adolescent patients. exclusion criteria: 1. aspartate transaminase or alanine transaminase level \> 5 times unl 2. bilirubin \> 2.5 times unl 3. history of allergy, sensitivity, or any serious reaction to an echinocandin 4. invasive fungal disease at the time of enrolment 5. systemic antifungal therapy within 72 hrs before administration of the first dose of study drug 6. positive pregnancy test
a single escalating dose and multiple dose study of bay 1093884 in subjects with severe hemophilia types a or b, with or without inhibitors

Conditions: Hemophilia A; Hemophilia B

Summary: investigate the safety, tolerability and pharmacokinetics of bay1093884 after intravenous (iv) and subcutaneous (sc) administration of increasing single doses and sc administration of multiple doses.


Eligibility criteria:
inclusion criteria: * males with severe congenital hemophilia a or b defined as \<1% fviii or factor ix (fix) concentration by measurement at the time of screening or from reliable prior documentation * for subjects in cohorts i-iv, i-sc1 and i-sc2; if history of inhibitors is evident, inhibitor titer of ≥5 bethesda units (bu) at screening or prior to screening at any time from medical records. * age: 18 to 65 years of age at screening * body mass index (bmi): 18 to 29.9 kg/m² exclusion criteria: * subjects with known bleeding disorders (such as von willebrand factor \[vwf\] deficiency, fxi deficiency, platelet disorders, or known acquired or inherited thrombophilia etc.) other than congenital hemophilia a or b with or without inhibitors * history of angina pectoris or treatment for angina pectoris * history of coronary and/or peripheral atherosclerotic disease, congestive heart failure, disseminated intravascular coagulopathy, or stage 2 hypertension defined as systolic blood pressure (sbp) ≥160 mmhg or diastolic blood pressure (dbp) ≥100 mmhg even if controlled * history of thrombophlebitis, venous / arterial thromboembolic diseases (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, cerebrovascular accident, ischemic heart disease, transient ischemic attack) * known or suspected hypersensitivity of the immune system, history of anaphylactic reaction, known (clinically relevant) allergies, non-allergic drug reactions, or multiple drug allergies
single center post-market study of thrombolytic therapy using the versus™ catheter

Conditions: Blood Clots; Vascular Disease; Embolism Thrombosis; Cardiovascular Diseases; Lung Diseases

Summary: assess the functionality of the versus catheter for catheter-directed thrombolysis of pulmonary blood clots, including advanced imaging assessment. an evaluation of patient outcomes from the cases included in this study will also be conducted.

the objective of this study is to assess the functionality of the versus™ catheter for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients, including advanced computerized tomography angiogram (cta) imaging assessment. this study will include an evaluation of patient outcomes and physician user experience with the versus™ catheter among up to 10 patients meeting the criteria for enrollment.

Eligibility criteria:
inclusion criteria: * patients 18 - 80 years, inclusive * patients who present with submassive pulmonary embolism (pe) * patients requiring thrombolytic intervention to the pulmonary vasculature * physician decision to use the versus™ catheter during the treatment of the patient exclusion criteria: * concurrent treatment with thrombectomy * concurrent treatment with a catheter-directed thrombolysis device that is not the versus™ catheter * massive pulmonary embolism (pe) * active bleeding disorder1 * recent cerebrovascular accident or transient ischemic attack1 * recent neurosurgery1 * recent intracranial trauma1 * absolute contraindication to anticoagulation1 * bmi \> 45kg/m2 * in the opinion of the investigator, the participant is not a suitable candidate for the study

Keywords: thrombolysis pulmonary catheter hemodynamic monitoring catheter directed therapy
randomised controlled trial of a literacy sensitive decision aid for bowel cancer screening

Conditions: Colorectal Neoplasms

Summary: the purpose of this study is to evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing.

several countries have recently implemented national bowel cancer screening programs. to ensure equal access to screening, consumer information is needed to suit adults ranging in literacy level. decision aids (das) are tools which have been developed to assist patients and consumers make informed health decisions and encourage active participation in health care decisions. their use in a wide range of clinical settings has increased dramatically. however, most das are highly dependent upon high levels of literacy and numeracy, and few have been developed for low literacy populations. this primary aims of this study are to assess the impact of the decision aid on (1) the proportion of adults who make an informed choice about bowel cancer screening (using faecal occult blood test) and, (2) the level of involvement in screening decisions among adults with lower levels of education and literacy. there are three secondary aims of the study. first, to measure the effect of the decision support tool on decisional conflict, decision satisfaction, anxiety, and bowel cancer worry. second, to identify participant's screening interest, intentions and behavior. thirdly, we will explore participant's reactions towards the information materials they receive and whether the doctor influenced their screening decision.

Eligibility criteria:
inclusion criteria: * men and women aged 55-64 years * lower levels of education * english as a main language spoken at home * average risk of bowel cancer exclusion criteria: * higher levels of education * invitation to take part in bowel cancer screening in last two years * personal or strong family history of bowel cancer * had a bowel cancer screening test in the last two years

Keywords: decision support techniques
oral iron in children with chronic kidney disease

Conditions: Chronic Kidney Insufficiency; Chronic Kidney Diseases

Summary: this is a pilot clinical trial of oral iron therapy in children with chronic kidney disease (ckd) and mild anemia. eligible children will be randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months. the outcomes will include muscle strength, physical activity, and changes in eating behavior, which will be measured at enrollment and at the end of the study period.


Eligibility criteria:
key inclusion criteria: * age 1-21 years old (muscle strength will be assessed only in children \>3 year old) * estimated glomerular filtration rate (gfr) \< 90 ml/min/1.73m2 by bedside schwartz formula \[height (cm) \*0.413 / serum creatinine (mg/dl)\] * hemoglobin (hb) more or equal than 9.0 at the previous clinic visit * hb less than 11.5 g/dl in children younger than 5 years hb less than 12.0 g/dl in children 5-12 years hb \ 15 yrs. hb \ 15 years (all at the previous clinic visit) children with transferrin saturation ≤ 20% and serum ferritin ≤ 100 ng/ml will be randomized into one of the arms key exclusion criteria: * transferrin saturation \<5% * serum ferritin \< 10 ng/ml * iron therapy or erythrocyte stimulating agents (erythropoietin) therapy within 3 months prior to randomization * blood transfusion within 4 months prior to enrollment * children on hemodialysis * rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months * pregnancy and breast-feeding

Keywords: anemia iron children chronic kidney disease (ckd) appetite physical activity muscle strength
improving medication adherence through a health literacy-based intervention for coronary heart disease patients

Conditions: Coronary Disease

Summary: this is a multi-center pilot study to examine the effectiveness of a health literacy-based intervention to improve medication adherence and self-efficacy of medication use among individuals with coronary heart disease (chd). the specific aims are to: i) develop a health literacy-based intervention to improve medication adherence for chd individuals with low health literacy and ii) evaluate the effects of a health literacy-based intervention on improving medication adherence and self-efficacy in chd individuals.

the project will be conducted in 2 phases. phase 1 is to develop the health literacy-based intervention that consists of a video and an education booklet. phase 2 is to conduct a pilot study to evaluate the effectiveness of the intervention. a total of 60 participants with low health literacy and diagnosed with chd will be recruited in two settings. data will be collected at baseline and 4-weeks after enrollment. the following data will be collected: at baseline: socio-demographic information (e.g. age, gender, education level, income, past medical history, social support), health literacy (eligibility screening at time of recruitment), chd knowledge, medication adherence, and medication self-efficacy. 4-weeks after enrollment: medication self-efficacy and medication adherence.

Eligibility criteria:
inclusion criteria: * aged ≥18 years and diagnosed with chd. * currently receiving pharmacological therapy such as statins, anti-platelet and/or blood thinner, beta-blockers, calcium channel blockers, nitroglycerin, and angiotensin- converting enzyme inhibitors (ace). * low health literacy score of 9 or less as measured using the short-form mandarin health literacy scale (s-mhls). exclusion criteria: * history of significant cognitive impairment, psychiatric disorders, and aphasia. * without access to a telephone or unable to give telephone contact. * currently enrolled in another program or clinical trial.
effectiveness of prophylactic antibiotics therapy in laparoscopic cholecystectomy on infection rate

Conditions: Cholecystitis

Summary: 529 patients performed elective lcc at chonbuk national university hospital between april 2014 and august 2015. total 509 patients were enrolled by inclusion criteria. they were randomized studied by comparing with antibiotic group (n=249, ag, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, nag) by table of random numbers. the clinical variables were pre and post-operatively blood tests enclude wbc, esr, crp, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

529 patients performed elective lcc at chonbuk national university hospital between april 2014 and august 2015. total 509 patients were enrolled by inclusion criteria. they were randomized studied by comparing with antibiotic group (n=249, ag, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, nag) by table of random numbers. the clinical variables were pre and post-operatively blood tests enclude wbc, esr, crp, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

Eligibility criteria:
inclusion criteria: patients who have diagnosed -cholecystitis with / without gb stone, gb polyp exclusion criteria: 1. suspected cholangitis and gb cancer 2. cbd stone history 3. preoperative administration of antibiotics within 7days. 4. suspected pregnancy 5. open conversion. 6. patients refuse this study

Keywords: gb stone
a study to evaluate the safety and efficacy of mabthera (rituximab) in combination with methotrexate (mtx) in participants with active rheumatoid arthritis who failed on anti-tumor necrosis factor alpha therapy

Conditions: Rheumatoid Arthritis

Summary: this study will assess the safety and efficacy of rituximab combined with mtx in participants with active rheumatoid arthritis (ra) who have had an inadequate response to anti-tumor necrosis (tnf) alpha therapy. the anticipated time in the study is up to 2 years and the target sample size is 500 participants. eligible participants may receive re-treatment with rituximab under a separate protocol wa17531.


Eligibility criteria:
inclusion criteria: * adult participants 18-80 years of age with active ra for at least 6 months; * received treatment for ra on an outpatient basis and experienced an inadequate response or intolerance to treatment with at least 1 anti-tnf alpha therapy (etanercept, infliximab or adalimumab); * must have received mtx for a minimum of 12 weeks, with the last 4 weeks, prior to screening at a stable dose; * participants with swollen joint count (sjc) and tender joint count (tjc) of at least 8 joints at screening and at randomization; * radiographic evidence of at least 1 joint with a definite erosion due to ra; * participants of reproductive potential must be using reliable contraceptive methods. exclusion criteria: * bone or joint surgery within 8 weeks prior to screening or joint surgery planned within 24 weeks of randomization; * class iv functional status of ra; * previous treatment within 6 months with intravenous gamma globulin, or the prosorba column; * intraarticular or parenteral corticosteroids within 4 weeks prior to screening visit; * with a live vaccine within 4 weeks prior to randomization; * previous treatment with rituximab or other cell-depleting therapies; * concurrent treatment with any disease-modifying anti-rheumatic drug (except for mtx) or any anti-tnf alfa factor or other biologic therapy; * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies; * evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders; * known contraindications to receiving rituximab; * known active bacterial, viral, fungal, mycobacterial or other infection; * history of recurrent significant infection or history of recurrent bacterial infections; * primary or secondary immunodeficiency (history of, or currently active); * history of cancer, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that have been excised and cured); * women who are pregnant or breast-feeding; * history of alcohol, drug or chemical abuse within 6 months prior to screening; * neuropathies and neurovasculopathies which might interfere with pain evaluation; * participants with poor peripheral venous access; * intolerance or contraindications to oral or intravenous corticosteroids.
fst-201 in the treatment of acute fungal otitis externa

Conditions: Acute Fungal Otitis Externa

Summary: the objective of this study is to evaluate the efficacy of fst-201 compared to vehicle in the treatment of acute fungal otitis externa. this trial is designed to enable filing of a new drug application in support of fst-201 for the indication of acute fungal otitis externa.


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of afoe of in one or both ears, based on a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1) and/or 1 for pruritis (absent = 0, present = 1) * have appearance consistent with fungal debris, i.e. white or black appearance consistent with aspergillus spp. or candida spp. * be at least 18 years of age at visit 1 (day 1, screening/baseline) of either sex and any race * provide written informed consent * be willing and able to follow all instructions and attend all study visits * if female and of child bearing potential, agree to and submit a urine sample for pregnancy testing at visit 1 and upon their exit from the study. post menopausal is defined as having no menses for 12 consecutive months. exclusion criteria: * have known sensitivity to any component of the study medications * have a current infection requiring systemic antimicrobial treatment * take any systemic (within 30 days) or otic corticosteroids (within 1 day) prior to visit 1 * have used topical or systemic anti-inflammatory agents on the same day as visit 1 and for the duration of the study * have used topical or systemic pain medications on the same day as visit 1 and for the duration of the study * have used any topical otic treatment within 1 days prior to visit 1
use of 405nm blue light emitting diode in the treatment of women with vulvovaginal candidiasis: a clinical trial

Conditions: Candidiasis, Vulvovaginal

Summary: vulvovaginal candidiasis (cvv) is an infectious process of the female genitourinary tract, an important health issue due to the high incidence and difficulties encountered in the treatment. therefore, new therapeutic modalities are sought with the capacity to minimize drug side-effects and to reduce recurrent cases. the objective of this stufy is to evaluate the clinical and microbiological response of the 405 nm blue light emitting diode in the treatment of women with vulvovaginal candidiasis and in women with healthy gentourine treatment. a clinical trial was conducted involving 40 women, divided into two groups, the first group consisting of women with a confirmed cvv diagnosis and a second group formed by women with a healthy genitourinary tract, without symptoms and symptoms of the disease. both groups underwent clinical evaluation and examination with endocervice collection with gynecologist before and after a session of application of the blue light emitting diode of 405 nm, lasting 4.5 minutes. there will also be an evaluation of the effects of the diary through the questionnaire answered before and after the participants' treatment. it is expected that the 405 nm blue led will destroy the cvv fungus demonstrated by laboratory examination and also improve the signs and results analyzed by the gynecologist and participants.

a current treatmente proposal is the use of blue led of 405 nm wich is a light that has antimicrobial effect when exposed to endogenous porphyrin of the pathogens. this exposition produces reactive oxigen and it causes cells death with no possibilities of resistance by the fungus.

Eligibility criteria:
inclusion criteria: * women betwen 18 and 65 years old, with clinical suspect of vulvovaginal candidiasis and with health vaginal tract exclusion criteria: * women with pacemakers, with diagnosis and / or suspicion of neoplasias, cognitive deficits, neurological and / or psychiatric diseases, pregnant women and women who have used oral antibiotics, fungicides, corticosteroids and vaginal creams in the last 30 days

Keywords: blue light emitting diode women
radionecrosis and fdg pet

Conditions: Malignant Glioma

Summary: gliomas are the most common malignant primary central nervous system (cns) tumours. when high-grade gliomas (hgg) recur, subsequent magnetic resonance (mri) imaging, with additional sequences is required.the positron emission tomography (pet) radiotracer \[18f\]-fluorodeoxyglucose (fdg) will be used in this study to distinguish between changes seen on mri which can be a reflection of pseudoprogression, radiation necrosis, or recurrence.

molecular imaging has been used to distinguish recurrent tumor from post-treatment changes through the use of positron emission tomography (pet) as well as other techniques. the best-studied pet radiotracer for this application is \[18f\]-fluorodeoxyglucose (fdg). normal brain matter is very fdg-avid, making it more difficult to identify lesions and in addition, inflammation associated with radiation injury has been shown to be fdg avid. in light of this, variations of the standard fdg protocols have been proposed in order to increase overall accuracy, including dual time point imaging (dtpi), consisting of injecting the patient with the standard radiotracer and acquiring two sets of images several hours apart, typically the normal initial images in addition to a delayed acquisition set. there is good reason to suspect that dtpi fdg-pet would be useful a technique for characterizing lesions in the brain. it's been shown that fdg uptake by normal brain parenchyma initially increases then decreases with time, while tumor uptake typically increases and then plateaus. this pattern of increasing and then decreasing fdg activity has also been seen in inflammatory tissue. the difference in fdg uptake at different times is what allows for a better distinction between malignant and benign tissue.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * able and willing to comply with the study procedures * the patient must be followed at the ottawa hospital for a tissue-proven, grade iii or iv glioma. * the patient must have been treated in the past with radiotherapy for glioma. * a disease recurrence is suspected based on clinical symptoms and/or imaging results. exclusion criteria: * missing information regarding tumor type and grade * brain biopsy in the ten days preceding dtpi fdg-pet * breastfeeding or pregnancy * claustrophobia or inability to lie still in a supine position * unwillingness or inability to provide informed consent

Keywords: central nervous system tumours [18f]-fluorodeoxyglucose
pain control for laser epilation in pilonidal disease

Conditions: Pilonidal Disease

Summary: it's unclear if the application of topical lidocaine prior to laser follicle ablation is effective in reducing discomfort from the procedure. this study will use a doubly blinded case-control model to evaluate pain scores after the procedure comparing topical lidocaine to placebo.

patients presenting to a dedicated pilonidal care clinic who have at least 2 future laser follicle ablations planned will be queried to determine their interest in participating in the study. patients will be randomized to topical lidocaine or placebo, which will be applied for 30 minutes prior to the laser procedure, before which it will be removed. laser technicians will be unaware of which cream the patient received and will record a post-procedure likert pain score, from 0 to 10. patients will return in 6 to 8 weeks at which time they will crossover to the other group. patients who received lidocaine cream will receive placebo and patients who received placebo will receive lidocaine cream. cream removal and laser follicle ablation, with post-procedure pain score recording, will be conducted as during the first visit. twenty patients will be recruited and each patient will act as their own control.

Eligibility criteria:
inclusion criteria: undergoing laser follicle ablation for pilonidal disease and expected to need at least 2 more treatments - exclusion criteria: unwilling to consent, not expected to need at least 2 more laser follicle ablations, not a candidate for laser -