Kornimate/medical-research-clean huggingface dataset:
the influence of probiotics on the immunologic response to vaccinations in infants

Conditions: Immunity; Measles; Mumps; Rubella

Summary: background: it is well established that the presence of bacteria in the intestine has a profound influence on health. probiotics, ("beneficial bacteria") have shown ameliorating effects on various infectious diseases. the influence of probiotics on several immune-mediated conditions has also been investigated, among them, atopic dermatitis ("asthma of the skin"), and milk allergy. the precise mechanism of action of probiotics is not fully understood. several animal and human studies have shown the probiotic bacteria to influence the immune system. the aim of the present study is to evaluate whether supplementing the diet with oral probiotics affects the immune response of children following routine vaccination against 4 common childhood viral diseases: mumps, measles, rubella and varicella. objective(s) and hypothesis(es): hypothesis: administration of probiotics will increase the amount of antibodies produced following vaccination for measles, mumps, rubella and varicella, by over 15%. objectives: * to determine whether administration of probiotics during infancy influences antibody levels following the routine childhood vaccinations. * to determine whether administration of probiotics during infancy influences the rate of adverse effects following the routine childhood vaccinations. potential impact: vaccines, alongside with the discovery of penicillin, have been cited as the great public health successes of the 20th century. however, even in countries with maximal childhood immunization coverage, the protective effect is not optimal. for example, only 70% to 90% of children immunized against chickenpox are actually protected against the disease. if we succeed in raising these numbers, even by a single percent, it will have a huge impact on society.


Eligibility criteria:
inclusion criteria: * age: 9-11 months. * parent or guardian intending to follow the recommended immunization schedule in israel. * parent or guardian possessing sufficient knowledge of the hebrew language. exclusion criteria: * infants suffering from any chronic diseases / conditions resulting in immune depression. * infants taking medications affecting the immune system. * infants with permanent invasive catheters. * infants born prematurely (prior to gestational week 35) * parent or guardian objecting to collection of blood sample at the end of study.

Keywords: probiotics vaccines measles mumps rubella
trauma-focused psychodynamic psychotherapy for lgbt patients with post-traumatic stress disorder

Conditions: Complex Post-Traumatic Stress Disorder; Post-traumatic Stress Disorder

Summary: this is a pilot, open trial of trauma-focused psychodynamic psychotherapy for lgbt-identifying individuals who meet for dsm-5 defined post-traumatic stress disorder and are interested in receiving a research psychotherapy intervention. a sample of at least 15 therapy completers will be collected.

despite high prevalence of ptsd among lgbt individuals, there are no data characterizing the disorder in this population, nor its treatment. this represents an important under-researched area in lgbt care and treatment. the purpose of this study is: (a) to preliminarily characterize ptsd within an lgbt sample; and (b) to test out the preliminary effects and acceptability of a novel ptsd psychotherapy, trauma-focused psychodynamic psychotherapy, in this group. participants identifying as lgbt and meeting dsm-5 criteria for ptsd per a structured, reliable clinical interview for ptsd will receive 20-24 sessions of twice-weekly tfpp at no cost. participants will receive four detailed clinical research assessments, at baseline/study entry, week 5 of treatment, treatment termination/end (week 12), and 3-months after the end of treatment. tfpp is adapted from the only empirically supported, non-exposure focused psychodynamic therapy for panic disorder and anxiety disorders, panic-focused psychodynamic psychotherapy. tfpp aims to improve patients' ability to understand and manage strong, intense emotions that appear seemingly "out of the blue," which links to their tendency to reexperience traumatic events in the here-and-now. tfpp addresses the psychological meanings of symptoms and their relationship to traumatic events to help the patient understand underlying emotions triggering their symptoms and the ways in which trauma influences their current experiences. tfpp was developed for patients with complex ptsd, who often have multiple prior trauma exposures with no clear "index" trauma. moreover, tfpp also explicitly considers opportunities for patients to explore the broader context of their symptoms and difficulties, including but not limited to lgbt identity or experiences of oppression.

Eligibility criteria:
inclusion criteria: * identify as lgbtq * caps-5 diagnosed ptsd per dsm-5 criteria * stable medication for \>=2 months and ongoing during treatment exclusion criteria: * psychosis or bipolar disorder * primary substance use disorder * severe suicidality * severe depression per a reconstructed hamilton rating scale for depression score of \>=24 * organic mental syndromes interfering with trial demands

Keywords: ptsd psychotherapy psychodynamic lgbtq
analysis of hbv-specific immune response in patients with hbeag negative chronic hepatitis b treated with pegasys (peginterferon alfa-2a (40kd)) - immunology sub-study of ml18253

Conditions: Hepatitis B, Chronic

Summary: this study will evaluate immune responses in patients with hbeag-negative chronic hepatitis b treated with pegasys (peginterferon alfa-2a). eligible patients will have been randomized in study ml18253 to receive pegasys 180 mcg subcutaneously for 48 or 96 weeks. sample collection period for each patients will occur in the first 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients 18-55 years of age * chronic hbeag negative hepatitis b * liver disease consistent with chronic hepatitis documented by liver biopsy within 18 months prior to enrollment * participation in study ml18253. exclusion criteria: * interferon-based or any systemic anti-hbv therapy \</= 12 months prior to first dose of study drug * antiviral, anti-neoplastic, or immunomodulatory treatment \</= 12 months prior to first dose of study drug * nonresponders to previous interferon therapy and resistant to lamivudine * co-infection with hepatitis a, c or d, or with human immunodeficiency virus (hiv) * hepatocellular cancer * compensated (child a, score 6) or decompensated liver disease (child b or c) * history or evidence of medical condition associated with chronic liver disease other than hbv
study of sorafenib and docetaxel in metastatic prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to use sorafenib plus docetaxel to evaluate pharmacodynamics (pd) in patients with prostate cancer.

background prostate cancer is the most common malignancy in men and the second leading cause of cancer death among males in the western world. when tumors become refractory to androgen withdrawal therapy, chemotherapy represent a palliative treatment with an improvement on quality of life, particularly the combination of mitoxantrone and prednisone . this observation has led to numerous studies evaluating the potential use of new chemotherapeutic agents as docetaxel in patients with metastatic androgen independent prostate cancer. recently docetaxel based regimens have shown an improvement in survival when compared with mitoxantrone in a phase iii trial . however the prognosis of these patients remains very poor and new effective tolerated approaches are needed to improve the results of chemotherapy. rationale in a recent study a raf kinase inhibitor protein (rkip) encoded by a suppressor gene was found to be responsible of the metastatic process; in fact the decreased rkip expression was associated with increased invasive capability of prostate cancer cells, presumably though the activation of mek and erk by phosphorilation . sorafenib, a novel signal transduction inhibitor, prevents tumor cell proliferation and angiogenesis blocking raf/mek/erk pathway at the level of raf kinase and tyrosine kinase receptors vegfr-2 and pdgfr. in a phase i study the combination of docetaxel and sorafenib was evaluated in prostate and other tumors . the treatment was well tolerated and one partial response (4%) and 12 stable disease (50%) were reported. according to these data we designed a phase ii study to evaluate the association of sorafenib and docetaxel in metastatic prostate cancer simon's optimal two-stage design for phase ii clinical trial will be applied to calculate the sample size that minimizes the expected number of patients to be accrued. the sample size will be calculated on the following assumptions: alpha error =0.05, beta error =0.20; pd (clinically uninteresting true no progressive disease rate) and p1 (sufficiently promising true no progressive disease rate) will be set at 60% and 80%. 11 patients will be enrolled in the first stage: if no progressive diseases are \ = 7 no progressive diseases 32 more patients will be accrued at the second stage. the treatment will be accepted if \>= 30 no progressive diseases out of 43 patients will be observed

Eligibility criteria:
inclusion criteria: * patients with metastatic hormone refractory prostate cancer

Keywords: prostate cancer sorafenib nexavar docetaxel pisa ricci
hemodynamic and headache-inducing effect of intravenous vasoactive intestinal peptide in migraineurs

Conditions: Headache; Migraine; Vasoactive Intestinal Peptide; Ultrasonography, Doppler, Transcranial

Summary: we hypothesized that infusion of vip may induce headache/migraine in migraineurs and that vip-induced headache may be associated with dilation of intra- and extracranial vessels. to test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters.

we hypothesized that infusion of vip may induce headache/migraine in migraineurs and that vip-induced headache may be associated with dilation of intra- and extracranial vessels. to test this hypothesis, we performed a double blind placebo-controlled crossover study in migraineurs and studied the effect on headache and cerebral and systemic hemodynamic parameters. the subjects were randomly allocated to the infusion of 8pmol/kg/min vip or placebo (isotonic saline), duration 25min. headache intensity, mean velocity of blood flow in the middle cerebral artery (vmmca), superficial temporal artery diameter, end-expiratory co2 and vital signs were recorded at baseline and then every 10 min until 120 min after start of the infusion. the patients received a headache diary for the following 12 hours after infusion.

Eligibility criteria:
inclusion criteria: * migraineurs exclusion criteria: * cerebrovascular disorders, pregnancy, nursing

Keywords: migraine vip transcranial doppler headache
feasibility controlled trial of tibial nerve stimulation for stroke related urinary incontinence

Conditions: Stroke; Urinary Incontinence

Summary: to aim of this study is to establish the feasibility of undertaking a phase iii trial of transcutaneous posterior tibial nerve electrical stimulation (tptns) to alleviate stroke-related urinary incontinence.

stroke-related urinary incontinence (ui) persists in more than one third of stroke survivors. it is associated with significant burden including reduced quality of life, increased morbidity and disability. urgency ui, together with overactive bladder (oab) symptoms (frequency, urgency, nocturia), is most commonly experienced. current continence care is limited to lifestyle advice and behavioural interventions such as voiding programmes. there is a reliance on containment approaches and a lack of available options for active treatment. intermittent electrical stimulation of the posterior tibial nerve (tptns) is effective for treating non-stroke neurogenic ui and oab, but has not been tested in the stroke population. this pilot randomised controlled trial (rct) aims to test the potential effectiveness of tptns for stroke-related bladder dysfunction. adults with stroke-related ui will be randomised to tptns or sham. they and/or their carer will be taught to self-deliver a programme of tptns over a six week period. bladder function, associated healthcare costs and quality of life outcomes will be measured at 6, 12 and 26 weeks. a nested process evaluation will be conducted. pilot rct and process evaluation results will inform the design of a phase iii rct of tptns to treat urinary incontinence in the stroke population.

Eligibility criteria:
inclusion criteria: * men or women aged ≥ 18 years, with a diagnosis of stroke based on the who criteria (who 1989) and stroke-related urinary incontinence of at least once weekly. * onset of stroke ≥ 4 weeks previously and discharged from hospital to own home following a new stroke episode within the previous 6 months. * physically, cognitively and communicatively able and willing to learn to apply tptns or has carer who is able and willing to learn. exclusion criteria: * pre-existing urinary incontinence prior to stroke. * current urinary tract infection. * voiding dysfunction requiring intermittent/indwelling catheterisation. * cardiac pacemaker in situ. * concurrent neurological diagnosis eg dementia, multiple sclerosis, diabetic neuropathy. * reduced/absent sensation at electrode placement sites. * post-void residual urine volume of \> 150ml.

Keywords: transcutaneous posterior tibial nerve stimulation randomised controlled trial feasibility
study of difluprednate ophthalmic emulsion in the treatment of uveitis

Conditions: Anterior Uveitis

Summary: the purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.

the primary objective was to investigate the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for treatment of this disease in the early phase of development, in comparison with rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid ophthalmic solution. the secondary objective was to establish the evaluation system for a dose-finding study.

Eligibility criteria:
inclusion criteria: * patients with endogenous anterior uveitis (including panuveitis) * patients with 20 or more anterior chamber cell within one field of the aqueous humor (grade 3 or higher in clinical signs and grading) as measured with a slitlamp microscope * patients aged ≥20 years and \<75 years who could clearly express their subjective symptoms (patients aged 20 years at giving informed consent were included in the study.) * patients giving written informed consent prior to initiation of the study exclusion criteria: * patients who did not meet all of the above inclusion criteria * patients receiving systemic administration or topical administration to the head or face including instillation of corticosteroid, nonsteroidal anti-inflammatory drugs, antiphlogistic enzymes, immunosuppressive drugs or colchicines within 1 week before the initial instillation of the study drug * patients with glaucoma or ocular hypertension (iop ≥21 mmhg) * patients with corneal erosion or corneal ulcer * patients with viral keratoconjunctival diseases, tuberculos eye diseases, fungal eye diseases or bacterial eye diseases * patients with diabetes mellitus * patients with allergy to corticosteroids * patients requiring use of contact lens during the study period * women who were or might be pregnant * patients participating in other clinical studies within 6 months before initiation of the present study * patients with sensitivity to steroids(patients who previously exhibited increased iop after instillation of a steroid ophthalmic solution) * patients with fibrins to such an extent that might affect measurement of flare
68ga-dota-noc pet/ct in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the investigators aim to evaluate the role of 68ga-dota-noc pet/ct in patients with idiopathic pulmonary fibrosis, in particular in patients with a diagnosis of ipf/uip (idiopathic pulmonary fibrosis, diagnosed based in the american thoracic society and european respiratory society criteria) and in forms of nsip (non-specific interstitial pneumonia). pet/ct imaging data will be compared with hrct (high-resolution computed tomography) findings to assess disease extension, early disease detection and to non-invasively detect somatostatin receptors expression at lung level in these patients, with potential therapeutic implications.

idiopathic pulmonary fibrosis prognosis remains severe, in particular for ipf, the most common entity. moreover, current treatment options are largely ineffective and do not change the natural course of the disease. pre-clinical evidence supports somatostatin receptors expression in the lung of patients with ipf. recently new pet tracers (somatostatin analogues labelled with 68gallium), specifically binding to somatostatin receptors, have been developed and are used in neuroendocrine tumours clinical trials. aim of the present study is to evaluate the role of 68ga-dota-noc pet/ct in patients with idiopathic pulmonary fibrosis, in particular in patients with ipf/uip and in cases with nsip, that are characterized by a more indolent progression. pet/ct data will be compared with hrct findings for the early detection of fibrotic areas and to non-invasively assess somatostatin receptors expression at lung level in these patients, with potential therapeutic implications. moreover, the suvmax (maximum standardized uptake value) will be analyzed in comparison with disease site and extension on hrct.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of ipf and nsip, based on the american thoracic society/european respiratory society consensus conference * age ≥ 18 years * males/females * signed informed consent exclusion criteria: * pregnancy * breast feeding * healthy volunteers * paediatric cases * patients in emergency situations * patients legally incompetent * patients who refuse to sign the informed consent

Keywords: pet/ct 68ga-dotanoc ipf nsip idiopathic pulmonary fibrosis
cough assist in bronchiolitis

Conditions: Bronchiolitis; Respiratory Syncytial Virus

Summary: rsv bronchiolitis in children is still associated with significant morbidity and mortality. rsv infection results in increased mucus production, edema and inflammation at the lower airways and impaired mucociliary clearance. infants and children under the age of 1 year are particularly vulnerable to complications such as atelectasis and secondary bacterial infection. these children often need non-invasive or invasive ventilation. atelectasis is common in these children because of smaller airways and decreased cough strength. there is still much uncertainty about the treatment of rsv. treatment consists primarily of supportive therapy such as tube feeding and additional respiratory support if necessary. there is also limited evidence about the use of nebulizers with beta-agonists and/or hypertonic saline. the cough assist is a mechanical in- and exsufflator used primarily in patients with neuromuscular diseases to augment cough capacity. in these patients, it was demonstrated that the use of assisted cough resulted in a significant decrease in the number of respiratory infections. moreover, there is evidence that when used in the case of an acute respiratory deterioration such a massive atelectasis, the atelectasis can be corrected and intubation can be avoided. the aim of this study is to investigate if the use of the coughassist device in children with rsv bronchiolitis is associated with a better respiratory outcome.


Eligibility criteria:
inclusion criteria: * children between 3 and 18 months admitted to our hospital with a clinical diagnosis of bronchiolitis in the rsv season or with a positive nasopharyngeal aspirate for rsv. exclusion criteria: * children with congenital cardiac disease. * children with cystic fibrosis. * children with reactive airways disease. * children with neurological impairment including cerebral palsy. * children with neuromuscular disease. * children with upper gi surgery. * children with emphysema. * children with a known susceptibility to pneumothorax or with a pneumothorax in the past.

Keywords: bronchiolitis respiratory syncytial virus cough assist physiotherapy
clinical and biological predictors of covid-19 disease in older patients

Conditions: COVID-19

Summary: the project is an observational, prospective study. its aim is to deepen our understanding of covid-19 in older patients hospitalized and diagnosed with covid-19. in particular, socioeconomic, diagnostic, biological, functional, therapy data will be collected at the patients' admission, during hospital stay, at the discharge and 1, 3, 6, 12 months after discharge. results and findings will help support changes in clinical practice and decision making, with the aim to reduce the use of healthcare services and the healthcare expenditure.

current knowledge about clinical and biological characteristics of covid 19 among older people is very limited. a better comprehension of the clinical picture of older patients affected by covid-19, (e.g. frailty, multimorbidity and polypharmacy patterns and functional performance) may significantly contribute to deepen our understanding of the clinical epidemiology knowledge of covid-19 among hospitalized older people. therefore, the reportage-covid project aims to collect - using a minimum clinical and biological data set - a series of data and indicators on the conditions of elderly patients that are suspected of having a compatible clinical picture or were confirmed positive for covid-19. data will be collected at the patients' admission, during hospital stay, at discharge and 1, 3, 6, 12 months after discharge. in particular, the following specific pieces of information will be gathered: * routinely collected demographic, socioeconomic, clinical, biological and diagnostic data * frailty condition (by using the clinical frailty scale) * assessment of the functional capacities through adl and iadl tests * health conditions; nutritional status; medications; treatments and procedures * biomarkers of aging including cytokines and anti-inflammatory molecules, previously identified in a focus group of experts results and findings will help support changes in clinical practice and decision making, with the aim of reducing adverse outcomes, the worsening of health conditions in the elderly population, the use of healthcare services and, as a consequence, lower healthcare expenditure.

Eligibility criteria:
inclusion criteria: * diagnosis of covid-19 exclusion criteria: * no informed consent

Keywords: covid-19 older people sars-cov-2 frailty physical function biomarkers of inflammation
validation and characterization of signal decrease on an oximeter in copd (they have chronic obstructive pulmonary disease) patients during deep inhalation (

Conditions: Pulmonary Disease; Copd

Summary: the objective is to verify that there is a decrease in the pulsed oxygen saturation with the digital sensor. that is, the drop in oxygen saturation in copd patients during inhalation is real and not due to an artifact of the measuring tool, because oximeters need a quality pulsatile signal to properly measure oxygen saturation


Eligibility criteria:
healthy arm inclusion criteria: * healthy adults volunteers are recruited from students with normal lung function. exclusion criteria: * abnormal lung function copd arm inclusion criteria: * adults with chronic obstructive pulmonary disease exclusion criteria: * cardiovascular disease the subjects selected are selected on a voluntary basis among the patients coming to the pulmonary consultation. they have chronic obstructive pulmonary disease.

Keywords: copd