Kornimate/medical-research-clean huggingface dataset:
a re-licensing study to assess the efficacy of inflexal v formulated with who recommended 2008/2009 influenza virus strains for the northern hemisphere

Conditions: Influenza

Summary: a study to assess whether the northern hemisphere 2008/2009 season influenza vaccine inflexal v fulfills the emea requirements for re-registration of influenza vaccines


Eligibility criteria:
inclusion criteria: * healthy female and male adults * aged ≥18 to ≤60 years or \>60 years on day 1 * written informed consent exclusion criteria: * acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease * acute febrile illness (≥38.0 °c) * prior vaccination with an influenza vaccine in the past 330 days * known hypersensitivity to any vaccine component * previous history of a serious adverse reaction to influenza vaccine * history of egg protein allergy or severe atopy * known blood coagulation disorder * chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of study vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed * known immunodeficiency (incl. leukemia, cancer, hiv seropositivity) * investigational medicinal product received in the past 3 months (90 days) * treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) * pregnancy or lactation * participation in another clinical trial * employee at the investigational site, or relative or spouse of the investigator * suspected non-compliance

Keywords: influenza virus vaccination immunisation
re-licensing study to assess inflexal v formulated with who recommended influenza strains

Conditions: Influenza

Summary: the study is to assess whether the influenza vaccine inflexal v for season 2012/2013 fulfills the ema requirements for re-registration of influenza vaccines.


Eligibility criteria:
inclusion criteria: * healthy female and male adults aged ≥18 on day 1 * written informed consent * female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years exclusion criteria: * acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease * acute febrile illness (≥38.0 °c) * prior vaccination with an influenza vaccine in the past 330 days * known hypersensitivity to any vaccine component * previous history of a serious adverse reaction to influenza vaccine * history of egg protein allergy or severe atopy * known blood coagulation disorder * chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed) * known immunodeficiency (incl. leukemia, hiv seropositivity), cancer * investigational medicinal product received in the past 3 months (90 days) * treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) * pregnancy or lactation * participation in another clinical trial * employee at the investigational site, or relative of the investigator * subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

Keywords: influenza virus vaccination inflexal v
dietary choice for the management of cow's milk allergy influences other allergic manifestations

Conditions: Allergy Milk; Allergy;Food; Allergic Asthma; Allergic Conjunctivitis; Allergy Skin

Summary: food allergy is a common chronic condition in childhood. recent studies have suggested that the natural history of food allergy has changed during the last two decades, with an increased prevalence, severity of clinical manifestations, and risk of persistence into later ages. the increased food allergy prevalence in children has an important economic impact, with significant direct costs for the healthcare system and even larger costs for the families of food-allergic patients. in addition, children with food allergies are at increased risk to develop other allergic manifestations later in life. according to a recent study, children with a food allergy are 2 to 4 times more likely to develop other atopic manifestations such as asthma (4.0 times), atopic eczema (2.4 times), and respiratory allergies (3.6 times), compared to children without a food allergy. cow's milk allergy is among the most common food allergy in early childhood, with an estimated prevalence of 2% to 3%. it has been previously showed that in children with cow milk allergy, an extensively hydrolysed casein formula supplemented with the probiotic lactobacillus rhamnosus gg induced higher tolerance rates compared to extensively hydrolysed casein formula without lactobacillus rhamnosus gg and other formulas. these findings were consistent with those of a 1-year follow-up study performed in the us that showed better outcomes using an extensively hydrolysed casein formula+lactobacillus rhamnosus gg vs. an extensively hydrolysed casein formula or amino acid-based formula for the first-line dietary management of cow milk allergy. in addition it has been recently demonstrated that extensively hydrolysed casein formula + lactobacillus rhamnosus gg reduces the incidence of other atopic manifestations and hastens the development of oral tolerance in children with ige-mediated cow milk allergy. the present randomized controlled trial (rct) was designed to test whether different dietary interventions could influence the occurrence of other atopic manifestations in children with ige-mediated cow milk allergy.


Eligibility criteria:
inclusion criteria: * age 1-12 months * ige-mediated cma exclusion criteria: * cow's milk protein-induced anaphylaxis, * food protein induced enterocolitis syndrome, * other food allergies, * other allergic diseases, * non-cma-related atopic eczema, * eosinophilic disorders of the gastrointestinal tract, * chronic systemic diseases, * congenital cardiac defects, * active tuberculosis, * autoimmune diseases, * immunodeficiency, * chronic inflammatory bowel diseases, * celiac disease, * cystic fibrosis, * metabolic diseases, * malignancy, * chronic pulmonary diseases, * malformations of the gastrointestinal and/or respiratory tract, * administration of prebiotics or probiotics during the 4 weeks before enrolment.
seroconversion among staff at a large acute care hospital in denmark during the covid-19 pandemic

Conditions: Covid-19; Health Personnel; Personnel, Hospital

Summary: the aim of this study is to apply serology testing methods for sars-cov2 antibodies in samples collected from hcws in an acute hospital. this will enable the identification of those who are protected and non-infectious for sars-cov2 and those who are seronegative and therefore potentially susceptible and infectious on patient contact. prospective testing will provide data on the acquisition of sars-cov2 infections among hcws and associated risk factors for transmission during a pandemic at an acute care hospital facility in the capital region of denmark. hypothesis: serial seroconversion measurements in hospital employees improve the organization of the clinical treatment and care during the covid-19 pandemic at nordsjællands hospital and nykøbing falster county hospital.

the study is a prospective cohort study. weekly (in the first phase) and bi-weekly (in the second phase) serum samples will be drawn and shipped bi-weekly to laboratory collaborators in united kingdom for antibody analyses during the course of the local epidemic, expected to last 10-12 weeks or more. after the cease of the epidemic serum will be drawn in 3-monthly intervals in a smaller group of seroconverted volunteers to follow the long-lasting immunity of sars-cov-2 infection up to 5 years post-pandemic. nurses, medical doctors, biomedical laboratory scientists, social health care assistants, and few healthcare administrators (as controls) will be invited for enrolment. in hospitals, all departments with staff that are in physical contact with patients during the pandemic will be invited to participate in the study.

Eligibility criteria:
inclusion criteria: hospital employee - exclusion criteria: none

Keywords: healthcare workers health care workers hcw seroconversion
comprehensive acupuncture for depressive disorder with comorbid psychogenic pain

Conditions: Depression; Psychoneurotic; Pain

Summary: experimental and clinical studies have indicated that acupuncture has a good effect for depression and comorbid pain. the purpose of this research is to compare the effect of comprehensive electro-acupuncture therapy and western medicine citalopram for for depressive disorder with comorbid psychogenic pain. this research is a assessor blinded, randomized controlled trials. 60 patients will be randomly divided into comprehensive electro-acupuncture group and western medicine citalopram for 8 weeks treatment and the therapeutic effect is done at the end of 1,2,4,6,8 week.


Eligibility criteria:
inclusion criteria: * conform with the diagnostic criteria of depression according to diagnostic and statistical manual of mental disorders (dsm-5tm) * age from 18 to 50 year-old * patients with the first onset depression * patients with mild-to-moderate depression scored 12-30 by montgomery scale * patients with one psychogenic pain at least, and the degree of vas is 3 or more * volunteer participants willing to cooperate and obeying the treatment exclusion criteria: * pregnant woman * patients with severe primary diseases and acute diseases of heart, brain, liver, kidney and hematopoietic systems and infectious disease, malignant tumor * patients who can't stop taking drugs according to the requirement in the treatment period * patients with a history of schizophrenia and other mental disorders * patients with cognitive impairment or personality disorders * patients have serious suicide idea or suicidal behavior
analysis of capillary retinal and papillary vascularization in patients with amyotrophic lateral sclerosis - capisla

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis, or charcot's disease, is a neurodegenerative disease affecting motor neurons. the disease affects between 5 and 10 people per 100,000 in the world, nearly 7,000 patients are affected in france. the only therapeutic treatment available to date in france is riluzole, which slows the progression of the disease. amyotrophic lateral sclerosis is the first degenerative disease affecting motor neurons. however, recent evidence suggests that the impairment extends beyond motor neurons alone. optical coherence tomography analyzes made it possible to highlight ophthalmologic damage in patients with amyotrophic lateral sclerosis, in particular at the macula and papilla, although some results are contradictory. no angiographic optical coherence tomography analysis has been performed to date in patients with amyotrophic lateral sclerosis. however, in the hypothesis of microvascular involvement participating in the pathophysiology of neurodegeneration in amyotrophic lateral sclerosis, these examinations could provide relevant clinical and pathophysiological data by studying the retinal microvascularization of patients with the disease.


Eligibility criteria:
inclusion criteria: patient amyotrophic lateral sclerosis : * patient diagnosed with bulbar or spinal als defined according to el escorial criteria (probable or certain) * hospitalized in a day hospital at the angers university hospital as part of his usual follow-up control subject : * subject not affected by the disease studied and without a history of neurological disease. * subject matched in age and sex to a case (patient) for all participants: * major upon inclusion * signature of informed consent to participate in the protocol exclusion criteria: patient amyotrophic lateral sclerosis and control subject : * simultaneous participation in another intervention protocol with an experimental treatment * subject unable to express consent * known ophthalmologic pathology (maculopathy, glaucoma, optic neuropathy, retinopathy whatever the etiology) * diabetic subject * cardiovascular history * inability to perform the ophthalmological examinations of the study * pregnant, lactating or parturient woman * subject under duress psychiatric care * subject to legal protection * subject not affiliated or not beneficiary of a social security scheme
the application of pectoral nerve ii(pecs ii)block in breast fibroadenoma resection surgery

Conditions: Breast Neoplasms

Summary: patients were randomly assigned to the ga group, pecs ii group, or tpvb group using a computer-generated random number table. group assignments were kept in a sealed envelope, which was opened only after induction of general anesthesia on the day of surgery. this study was a double-blind trial, ensuring that neither the patients nor the investigators were aware of the analgesic method used. the same anesthesiologist was responsible for pecs ii block or tpvb, while different anesthesiologists were responsible for anesthesia implementation and postoperative follow-up.

written informed consent was obtained from all participants.90 female patients aged 18 to 65 with asa i-ii status were selected at baogang hospital, inner mongolia, who had been diagnosed with breast fibroadenomas. exclusion criteria included pre-existing infection at the site of block, coagulation disorders, morbid obesity (body mass index \&gt; 40 kg/m²), allergy to local anesthetics, impaired lung function, significant cardiac disease, renal dysfunction, pre-existing neurological disorders, and psychiatric conditions.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of breast fibromas exclusion criteria: * heart attack mental disorder
buprenorphine for treatment of neonatal abstinence syndrome in infants with in utero exposure to benzodiazepines

Conditions: Neonatal Abstinence Syndrome

Summary: the opioid neonatal abstinence syndrome (nas) is a condition of withdrawal symptoms after utero exposure to opioids. sublingual buprenorphine shows promise as a new treatment in nas. this trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.

infants with in utero exposure to opioids often require therapy with morphine for an extended period. in a clinical trial, sublingual buprenorphine reduced this treatment period by \~30%. however, infants with both opioid and benzodiazepine exposure were not included in the trial. this study will test the safety and tolerability of sublingual buprenorphine in infants with in utero exposure to benzodiazepines or who are breastfeeding.

Eligibility criteria:
inclusion criteria: 1. ≥ 37 weeks gestation 2. exposure to opioids in utero 3. demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment 4. exposure to benzodiazepines in utero and/or receiving breast milk. benzodiazepine use is defined as maternal use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth. exclusion criteria: 1. major congenital malformations and/or intrauterine growth retardation defined as birth weight \<2200 gm 2. medical illness requiring intensification of medical therapy. this includes, but is not limited to suspected sepsis requiring antibiotic therapy. 3. hypoglycemia requiring treatment with intravenous dextrose 4. bilirubin \>20 mg/dl (the need for phototherapy is not exclusionary) 5. seizure activity or other neurologic abnormality

Keywords: neonatal abstinence syndrome buprenorphine morphine benzodiazepine
the tailored adherence incentives for childhood asthma medications (taicam) trial

Conditions: Medication Adherence; Asthma in Children

Summary: improving adherence to inhaled corticosteroids (ics) medication in urban minority pediatric populations is a clinical and population health priority. financial incentives have been shown as a compelling method to engage a high-risk asthma population in regular ics use, but whether and how adherence can be maintained and lead to sustained high adherence trajectories is unknown.

investigators propose to initially enroll 125 children into an initial 1-month run-in interval. participants who successfully complete the run-in interval will be randomized into a six-month intervention with a six month follow-up period. children will be ages 5-12, and must have two or more visits to any combination of the outpatient, emergency department (ed) or hospital setting in the past year for asthma exacerbations at children's hospital of philadelphia (chop). the study intervention will include daily automated medication reminders (either via text message or push reminder), an app to track daily medication use, and nominal incentives to promote daily controller use. inhaled controller medication adherence and rescue medication use will be measured using electronic monitors affixed to the inhalers. factors associated with differential adherence will be assessed using surveys administered during enrollment, the experiment interval (months 1 through 3), the observation interval (months 4 through 6), and study completion (months 12-13). efficacy outcomes will include change in parent-reported asthma control and mean adherence to ics between study arms during the experiment interval, as well as the observation interval. patients will be considered fully enrolled when they fulfill the requirements of the run-in period (sensor data uploaded to research platform and text message receipt confirmed by caregiver) and are subsequently randomized.

Eligibility criteria:
inclusion criteria: * males or females age 5 to 12 years and their parent or legal guardian. * caregiver has an app enabled cellular phone (i.e., smart phone) * prescribed inhaled corticosteroid or corticosteroid/long acting beta agonist combination for daily use * at least 2 asthma exacerbations in the preceding year (any combination of hospitalizations, ed visits, or outpatient visits where oral steroid courses were administered for asthma) * parental/guardian permission (informed consent) and if appropriate, child assent. exclusion criteria: * subjects prescribed a controller medication to which the electronic device cannot affix * subjects in which the mobile app is not compatible with their smart phone model * subjects with major developmental delays or disabilities * subjects with comorbid chronic diagnoses that influence their asthma management such as cystic fibrosis, bronchopulmonary dysplasia, or cyanotic heart disease * families with active department of human services (dhs) involvement * non-english speaking families * parents/guardians or subjects whose medical team recommends against approaching for enrollment in a research study.
a clinical trial to evaluate the efficacy and safety of a spot stent system used in femoropopliteal arteries.

Conditions: Peripheral Vascular Disease (PVD); Peripheral Arterial Disease (PAD)

Summary: a prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.

the objective of this clinical investigation is to assess the efficacy and safety of spot stent system ,which is indicated for use in patients with atherosclerotic disease of the superficial femoral artery (sfa) or proximal popliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.

Eligibility criteria:
inclusion criteria: * age ≥18 years old and ≤80 years old * had lower extremity arterial occlusive diseases, and rutherford classification is 2-5 * target lesion is in the superficial femoral artery (sfa) and/or proximal popliteal artery (above the knee), located ≥1 cm below the common femoral artery (cfa) bifurcation to the distal segment of the proximal popliteal artery at the superior end of the patella. * target lesion had severe stenosis (stenosis degree ≥70%) or occlusion. * presence of at least one patent infrapopliteal vessel. * the length of target lesion ≥10 cm. * after predilation, the target lesion has \<30% residual stenosis and presence of at least one flow-limiting dissection (by visual estimate). * subject (or legal guardian) understands the study requirements and procedures and provides written informed consent before any study tests or procedures are performed. exclusion criteria: * the plasma creatinine level is higher than 150 umol/l. * thrombolysis or thrombectomy is required. * the patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks. * previously implanted stent in the target lesion. * the guide wire can not cross the target lesion. * angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable. * patient has a known allergy to anticoagulant drugs, anti-platelet drugs or contrast medium that cannot be adequately pre-medicated. * women who are pregnant or breast-feeding. * the subjects have participated in other drug property studies or device studies that have not yet completed the main end point. * patient has life expectancy of less than 12 months. * patient who planned to do above the ankle amputation before the operation. * patient who had severe hemorrhage or coagulation disorder which judged by the investigator. * the investigator think the patient is not suitable for participation in the clinical trial.
clinical study of angong niuhuang pill and acupuncture on psci angong niuhuang pill combined with supervised pulse music electroacupuncture on cognitive impairment after ischemic stroke

Conditions: Post-stroke Cognitive Impairment

Summary: post stroke cognitive impairment (psci) refers to the attainment of cognitive impairment after the clinical event of stroke a range of syndromes that impede diagnostic criteria. epidemiologically, psci is one of the common complications in stroke patients

(1) clinical scale data of cognitive function, daily living ability of psci patients integrated with the research of this project using uterine niu huang pill combined with examined pulse music electroacupuncture for analysis, the efficacy of psci patients was observed; (2) in depth studies on auditory event-related potentials of psci treated by uterine niu huang pill combined with examined pulse music electroacupuncture the changes of serum related nerve growth factor and the relationship between each other in order to enrich / fill our province's research results in this field; (3) in key academic journals 1 high level scientific research paper published.

Eligibility criteria:
inclusion criteria: (1) all were the first stroke, confirmed by head computed tomography (ct) or magnetic resonance imaging (mri), with vital signs stable; (2) those who are conscious and can cooperate with relevant treatment; (3) montreal cognitive assessment scale (moca) score ≤ 24 points; （4） the course of disease is more than 1 month, and the patient is 40-70 years old. exclusion criteria: (1) people with cognitive impairment before onset; (2) there are contraindications of angong niuhuang pill or electroacupuncture treatment; (3) complicated with dysfunction of heart, liver, kidney and other important organs; (4) previous history of cerebral hemorrhage, epilepsy, brain injury, etc; (5) before onset have a history of alcohol and drug dependence; (6) the condition worsens, and new hemorrhagic or infarcted foci appear. -

Keywords: post-stroke cognitive impairment;acupuncture