Kornimate/medical-research-clean huggingface dataset:
determination of levels of micafungin in neonates suffering from systemic candidiasis and/or candida meningitis

Conditions: Candidiasis, Systemic; Candida Meningitis

Summary: the primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis. this study will also evaluate the proportion of success and of failure of the therapy with micafungin among treated neonates and will identify a conversion factor to relate plasma levels of micafungin into capillary and venous blood measured through blood samples from the heel and from a peripheral vein, collected simultaneously. safety of micafungin in neonates will also be assessed.


Eligibility criteria:
inclusion criteria: * infection by systemic candidiasis systemic candidiasis is diagnosed in case of worsening of clinical conditions while on therapy with antibiotics, in case of isolation of candida from at least one sample collected from a normally sterile site (blood, csf, urine, peritoneal fluid) and/or from at least two non contiguous sites (tracheal aspirate, gastric aspirate, faeces) and/or positivity to candida through polymerase chain reaction (pcr)(septifast test), associated with at least one clinical symptom (fever or hypothermia, mottled skin, feeding difficulties, muscular hypotonia or hypertonia, apnoea crisis, bradycardia, tachycardia, hypotension, dyspnea, polypnea, desaturation) and one laboratory symptom (white blood cell \[wbc\] ≤5000/mm3 or wbc ≥20.000/mm3, immature to total neutrophil ratio \[i/t ratio\] \>2, platelet count ≤100.000/mm3, c-reactive protein \>0,5 mg/dl, standard base excess \>-7 mmol/l, csf pleocytosis-cells ≥ 6) and/or positivity to test enzyme linked immuno-sorbent assay (elisa) for the mannan antigen (≥125 pg/ml). * neonates affected by candida meningitis and/or hydrocephalus due to candida infection and/or bearing external ventricular derivation, until enrollment of at least 4 subjects with this characteristics. * parents of neonates, or legal representative, able to consent and comply with protocol requirements. * survival expectation not inferior to 3 days. exclusion criteria: * acute hepatopathy (ammonium \> 200 µg/dl) or chronic hepatopathy. * known allergy or hypersensitivity to echinocandins or any of the excipients present in the formulation of the investigational product.

Keywords: candida meningitis mycamine candidiasis, systemic micafungin
emtricitabine for naive chinese pregnant chronic hepatitis b patients

Conditions: Hepatitis B, Chronic; Pregnancy

Summary: this study evaluates generic emtricitabine(ftc) efficacy and safety in chinese naive pregnant chronic hepatitis b patients. single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.

single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include hbeag positive and negative patients.

Eligibility criteria:
inclusion criteria: * hbsag positive for more than 6 months * hbeag positive patients: hbv dna ≥ 5log10 copies/ml * hbeag postive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4 * hbeag negative patients: hbv dna ≥ 4log10 copies/ml * hbeag postive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4 * nucleoside/nucleotide naive patients * diagnosed as ≥ 12 weeks pregnancy exclusion criteria: * diagnosed hcc with afp and ultrasound, ct or mri * creatine \>130μmol/l or ccr \< 70ml/min * hemoglobin \<100g/l * coinfected with hav,hev,hcv,hdv or hiv * ana \> 1:100 * uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer * drug abuse or alcohal addiction * previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine * long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial * underwent liver transplantation or liver transplantation in schedule * allergic to nucleoside or nucleotide analogues * family history of genetic defects disease * abnormal results in fatal defects screening * hbsag positive sperm provider pregnancy

Keywords: hepatitis b, chronic emtricitabine pregnancy
multisensory room in autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) is a complex neurological development with onset in infancy or early childhood. atypical sensory processing has been widely reported in asd, and recent literature suggest that this abnormality extends across the life span, with consequent important implications in every-day life of autistic individuals and their families. multisensory environments have been used in children with asd precisely as a function of this particular difference in sensory processing and some studies have highlighted potential benefits. therefore, the aim of our study is to verify feasibility and efficacy of an integrated treatment program with the multisensory room compared to as usual treatment in patients with asd.

autism spectrum disorder (asd) is a complex neurological development with onset in infancy or early childhood. in the fifth edition of diagnostic and statistical manual of mental disorders, sensory features were finally take into account and atypical responses to sensory stimuli was included in the diagnostic criterion, such as the presence of hyper- or hypo-responsiveness to sensory inputs or unusual interests towards sensory aspects of the environment, and it must be considered (apa 2013). atypical sensory processing has been widely reported in asd, and recent literature suggest that this abnormality extends across the life span, with consequent important implications in every-day life of autistic individuals and their families. multisensory environments have been used in children with asd precisely as a function of this particular difference in sensory processing and some studies have highlighted potential benefits. the multisensory rooms were designed to provide multiple stimulation opportunities that cover all sensory channels. among the present literature data, interventions targeting sensory integration seems to be useful in reducing challenging behaviors in many individuals with developmental disabilities including asd (novakovic n. et al. 2019; kaplan h. et al., 2006; mckee et al. 2007). the aim of our study is to verify feasibility and efficacy of an integrated treatment program with the multisensory room compared to as usual treatment in patients with asd.

Eligibility criteria:
inclusion criteria: * patients diagnosed with diagnosis of asd, according to diagnostic and statistical manual of mental disorders (dsm-5) criteria; * age between 3 and 6 years; * signed informed consent and the availability of at least one family member to participate in the diagnostic/therapeutic process. exclusion criteria: * children not aged between 3 and 6 years; * significant medical conditions such as epilepsy, significant visual and auditory sensory deficits, traumatic brain injury, or significant genetic disorders. * informed consent not signed of at least one family member to participate in the diagnostic/therapeutic process.
developing and testing a personalized evidence-based shared decision-making tool for stent selection

Conditions: Heart Diseases

Summary: the goal of this study is to gather input from patients who have undergone pci, their family and/or caregivers, and clinicians to develop a patient decision aid. the purpose of the decision aid is to deliver information, including individualized estimates of patients' restenosis risk, in an understandable format that would be informative and assist in decision-making for patients undergoing pci.

study plan: qualitative research methods (focus groups) will be used to gather the information that would be helpful in decision making as well as review several possible output formats. several sets of focus groups will be convened, with particular attention to recruitment of a diverse population, including women and underserved minority groups. study procedure: we will gather input to create a clinically useful format for presenting the risk estimates for desired outcomes and support clinical decision-making. subjects: we anticipate 2 or 3 patient focus groups of 6-8 individuals and 2 clinician focus groups of 3-5 individuals will be scheduled. fliers will be posted to enlist potential patients. if necessary, patients will also be contacted by a cardiovascular research coordinator and invited to attend a scheduled focus group. after receiving patient/family/caregiver input, selected clinicians from the saint lukes hospital staff, including cardiologists, cardiac nurses and other cardiology staff, will be invited to attend a scheduled focus group. the invitation will be sent via email and followed up with a phone call, if necessary. if a clinician focus group is unable to be scheduled, then individual interviews will be conducted. setting: patient and clinician focus group sessions will be held at saint luke's hospital.

Eligibility criteria:
inclusion criteria: * \>18 years old * english or spanish speaking * presence of coronary disease, or a caregiver/relative of one with coronary disease exclusion criteria: * non-english or non-spanish speaking * dementia

Keywords: coronary artery disease cardiac stent pci procedure patient preference
changes of serum orphanin fq in patients with coronary heart disease in different courses of diabetes mellitus

Conditions: Type2 Diabetes

Summary: to explore the severity of diabetic patients with coronary heart disease and the change of serum orphanin fq content in different diabetic courses

methods: a retrospective case-control study was conducted. the control group was a patient who underwent coronary angiography at the same time and was definitely diagnosed as coronary heart disease but not diabetes. the study group was coronary heart disease complicated with diabetes, which was divided into group a (≤5 years), group b (5-10 years) and group c (10-20 years) according to the course of diabetes. (1) review the electronic medical records and record the general information of the selected patients: age, sex, history of hypertension, history of myocardial infarction, family history of coronary heart disease, smoking history, chronic kidney disease; ② laboratory findings: hba1c (glycosylated hemoglobin), sbp (systolic blood pressure), dbp (diastolic blood pressure), total cholesterol, hdl, ldl, triglyceride, bmi, creatinine and glomerular passing rate (egfr); ③ drug use: oral hypoglycemic agents, insulin, aspirin, statins, hypertension drugs, acei or arb, β-blockers, ccb and diuretics. (ii) taking coronary angiography as the gold standard, the grading index of severity of coronary heart disease was made, and the severity of coronary heart disease was evaluated by gensini score.

Eligibility criteria:
inclusion criteria: * the main discharge diagnosis is t2dm；; * age \> 18 years old; * no acute complications of diabetes; * the previous diagnosis was coronary heart disease exclusion criteria: * t1dm patients; * egfr \< 60 ml/min/1.73 m or proteinuria (or both); * patients with history of acute cardiovascular events; * familial hypercholesterolemia or other hereditary lipid metabolism diseases; * anti-hiv patients; * patients with serious mental health problems; * patients receiving drugs that can lead to dyslipidemia, such as antipsychotics, corticosteroids, or immunosuppressants; * patients with systemic inflammatory diseases, such as systemic lupus erythematosus; pet-name ruby is quitting smoking and severe obesity (bmi\>40).

Keywords: type 2 diabetes
visual health evaluation of natural color display technology

Conditions: Chromatic Adaptation

Summary: study on visual fatigue and visual function under changing ambient light color temperature by natural color mode: the influence of electronic display devices on visual fatigue of human eyes is the main evaluation index and the main outcome index of this experiment. secondary outcome indicators were visual function indicators such as regulation and aggregation. there are other outcome measures: effective reading efficiency, blink detection, retinal fundus blood flow. the baseline values of the above indicators were respectively measured, and then the specific values of different indicators when the natural color mode was enabled and not enabled were collected under the changing ambient light color temperature, and the baseline values were statistically compared and analyzed. evaluate the effect of natural color patterns on the relief of visual fatigue and on visual function.


Eligibility criteria:
inclusion criteria: 1. adult population, regardless of gender 2. refractive error is less than or equal to -2.5d and both eyes achieve corrected visual acuity of 0.8 or higher. 3. normal intraocular pressure with no organic pathology. 4. no apparent symptoms of dry eye. 5. willing to cooperate to complete all the tests. 6. voluntarily signing the informed consent form. exclusion criteria: * 1: individuals with strabismus and amblyopia exist. 2: suffering from congenital eye conditions such as congenital cataracts or congenital retinal diseases. 3: those who have undergone intraocular surgery (such as cataract removal, intraocular lens implantation, etc.). 4: individuals with refractive media opacity (such as corneal lesions, lens opacity, etc.). 5: abnormal intraocular pressure (iop) (iop \ 21 mmhg, or a bilateral iop difference of ≥5 mmhg). 6: only one eye meets the inclusion criteria. 7: active corneal infections such as bacterial, fungal, viral, or other acute or chronic anterior segment inflammations. 8: currently using medications that may lead to dry eye or affect vision and corneal curvature. 9: other ocular conditions, such as dacryocystitis, eyelid disorders and abnormalities, abnormal intraocular pressure, and glaucoma. 10: unable to undergo regular eye examinations.

Keywords: chromatic adaptation reading efficiency visual function visual fatigue fundus blood flow
metabolic therapy in patients with osteoporosis after hip fracture by an orthopedic-rehabilitation-metabolic team

Conditions: Hip Fracture

Summary: metabolic therapy in patients with osteoporosis after hip fracture by cooperation orthopedic-rehabilitation-metabolic: determination of drug treatment regardless of reaching the follow-up clinic

osteoporotic hip fractures are a significant cause of morbidity and mortality in older age. patients with this fracture are at high risk of further fracture, it can be reduced by appropriate metabolic therapy. however, only 30% of patients after a hip fracture receive basic treatment appropriate calcium and vitamin d, only 10-15% receive complementary metabolic therapy more drugs prevent bone resorption, or bone-building drugs as recommended in the literature, the prevention of further fractures. studies conducted in the past have proven, multi-disciplinary team of dedicated financial institution may increase appropriate treatment and improve the quality of care in these patients. previous data in our institution has shown that 84% of patients with hip fractures received calcium and vitamin d during hospitalization, but only 47% of the patients came to the metabolic clinic. moreover, of the patients who came to the metabolic clinic, only 46% were put on complementary metabolic therapy, mostly due to a lack of sufficient vitamin d level. in the present study investigators attempt to treat patients without physical attendance at the metabolic clinic.

Eligibility criteria:
inclusion criteria: * all patients were analyzed could department of orthopedics with a hip fracture exclusion criteria: -
retrospective real-life study from one brazilian reference center assessing long-term experience in the treatment of adult spasticity with abobotulinumtoxina

Conditions: Spasticity

Summary: the aim of the study is to describe the long-term use of abobotulinumtoxina (dysport®) in adult subjects affected with upper limb spasticity (uls) +/- lower limb spasticity (lls) who received treatment with dysport® for a minimum of three injections cycles at the instituto de medicina física e reabilitação do hospital das clínicas da faculdade de medicina da universidade de são paulo (imrea hc fmusp) in brazil.


Eligibility criteria:
inclusion criteria: * adult aged ≥18 years old at the time of the first dysport® injection * diagnosed with spasticity * treated with a minimum of three dysport® injection cycles for uls +/- lls in the observational period * follow up effectiveness data are available in the subject's medical record exclusion criteria: * patients have received previous treatment with another bont-a less than 12 weeks prior to the patient data collection in the study * adults with cerebral palsy * patients treated with bont-a in a clinical trial setting
infrared thermography in finding skin lesions in patients with kaposi's sarcoma

Conditions: Sarcoma

Summary: rationale: diagnostic procedures, such as infrared thermography, may help find kaposi's sarcoma and learn the extent of disease. purpose: this clinical trial is studying how well infrared thermography finds skin lesions in patients with kaposi's sarcoma.

objectives: primary * compare ultra-sensitive infrared thermographic images with visible light digital photographic images and clinical dermatologic examination as methods of measuring cutaneous lesions in patients with kaposi's sarcoma (ks). secondary * compare differences in modulation of temperature detected in ks skin lesions with non-involved skin of the same patient and with normal skin of healthy volunteers by sequential imaging using the infrared thermographic camera. outline: this is a controlled, pilot study. patients undergo clinical assessment followed by simultaneous digital photographic camera imaging and high-resolution infrared thermographic camera imaging of designated normal skin areas and selected marker lesions. before imaging, a metal bar chilled to 0º c, 10º c, and 25º c is applied to the lesions and designated normal skin areas for up to 90 seconds. healthy volunteers (controls) undergo the same procedure as for the patient except only designated normal skin areas are used. projected accrual: a total of 20 patients and 10 healthy volunteers (controls) will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * histologically confirmed cutaneous kaposi's sarcoma (ks) * at least one skin lesion accessible for imaging * hiv positivity with proven cutaneous ks and concurrent visceral or mucous membrane involvement allowed * healthy volunteer (regardless of hiv status) (control) patient characteristics: performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * pregnancy allowed prior concurrent therapy: * prior topical, intralesional, or systemic treatment allowed

Keywords: kaposi sarcoma
study to assess the safety, tolerability and pharmacokinetics of azd2066 in young and elderly healthy subjects

Conditions: Pain

Summary: the purpose of this study is to investigate the safety and tolerability of azd2066 using multiple escalating dose panels. there will be separate panels for young healthy volunteers and elderly healthy volunteers. each panel will contain 10 volunteers who will randomly receive azd2066 or placebo. one panel will be run at a time with a fixed dose given. after the completion of each panel, a safety review committee will decide if the study can proceed to the next dose panel.


Eligibility criteria:
inclusion criteria: * provision of signed informed consent * clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ecg. exclusion criteria: * history of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator. * history of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder. * intake of medicine (except occasional paracetamol or nasal spray) within first 2 weeks before first administration of study drug.

Keywords: safety tolerability azd2066 pain conditions
tolerability of indacaterol salts (maleate, xinafoate and acetate) in comparison to placebo in patients with mild to moderate persistent asthma

Conditions: Asthma

Summary: this study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.


Eligibility criteria:
inclusion criteria: * male and female patients 18 to 65 years old (inclusive) * patients with mild to moderate persistent asthma * bmi must be within the range of 18-32 kg/m2 inclusive * female subjects must: 1. have been sterilized at least 6 months prior to screening 2. be post-menopausal with no regular bleeding for at least a year prior to inclusion exclusion criteria: * patients with life-threatening arrhythmias * patients with copd or diabetes mellitus * history of immunocompromise, including a positive hiv * a positive hepatitis b surface antigen (hbsag) of hepatitis c test result other protocol-defined inclusion/exclusion criteria may apply.

Keywords: asthma, cough, spirometry, maleate, xinafoate, acetate, sddpi (single dose dry powder inhaler)
desidustat in the management of covid-19 patients

Conditions: COVID-19

Summary: this study is a phase 2b, multicenter, open-label, randomized, comparator- controlled study to evaluate the efficacy and safety of desidustat tablet for the management of mild, moderate and severe covid-19 patients. 100 mg of desidustat will be administered for a period of 14 days along with recommended standard care during the trial.

this is a phase 2b, multicenter, open-label, randomized, comparator-controlled clinical trial to evaluate the efficacy and safety of desidustat for the management of covid-19 patients. first 12 mild to moderate subjects (test arm: desidustat + standard of care arm, 06 subjects and reference arm: standard of care, 06 subjects) will be enrolled in the study and after evaluation of safety of these 12 subjects by data monitoring committee other 12 severe subjects (test arm: desidustat + standard of care arm, 06 subjects and reference arm: standard of care arm, 06 subjects) will be enrolled in the study.

Eligibility criteria:
inclusion criteria: 1. ability to comprehend and willingness to sign a written icf by the subject/impartial witness. 2. male and females, age ≥18 years at enrollment. 3. understands and agrees to comply with planned study procedures. 4. agrees to the collection of pharyngeal swabs and blood sample as per protocol. 5. has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen within one week. 6. illness of any duration, and at least one of the following: 1. radiographic infiltrates by imaging (chest x-ray) 2. clinical assessment (evidence of rales/crackles or other clinical symptoms on exam). 7. women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site). exclusion criteria: 1. alt/ast \>5 times the upper limit of normal. 2. stage v ckd (i.e. egfr \<15 ml/min/1.73 m2 or requiring dialysis). 3. pregnant or breast feeding. 4. severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled dm, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment. 5. comorbid condition like myocardial infarction or heart failure within 90 days of recruitment. 6. prolong qt interval (\>450 ms). 7. patients on invasive mechanical ventilation.