Kornimate/medical-research-clean huggingface dataset:
premature family music therapy intervention (pfmi)

Conditions: Music Therapy

Summary: the music therapy intervention it is dedicated to premature baby and their family at the neonatal intensive care unit (nicu)of the woman-child department "hospital del ponte". in nicu an integrated psychological and music therapeutic protocol has been structured. the protocol aims to limit or overcome long-term developmental morbidities, promote parenting and attachment bond in preterm infants. protocol is named "premature family music therapy intervention (pfmi): an italian protocol to support parenting, attachment bond and preterm development". the methodologies will provide early intervention from the first days of hospitalization in nicu and use music therapy sessions "active" (chant parental, live music and lullaby) and "receptive" (listening to recorded tracks). such therapy becomes a support for the born prematurely and her parents during hospitalization and after discharge. the music therapy accompanies the newborn and his parents during the hospitalization and focuses its attention on the emotional-relational care, according to the different needs of babies and parents. this protocol it is a family centered care music therapy intervention.

all infants will be enrolled when in stable clinical condition within two weeks after birth. therapy sessions will take place minimum three times per week on three different days of the week directly at the unit during the entire hospitalization until discharge. after discharge music therapy treatment will be performed once a week until twelve months of corrected age. the infant's wellbeing and relaxation during each session of music therapy will be measured using the following parameters: hrv (heart rate variability) analysis oxygen's saturation stress level of the child infants will be followed till 12 months of corrected age. investigators will assess: neuro-behavioral and neurological development of the child stress level of the parents

Eligibility criteria:
inclusion criteria, preterm infants born, will be eligible for the study, if they will be: 1. born between 22+6- and 32-weeks postmenstrual age 2. weight less than 1500 g 3. free from major congenital defects 4. free from cerebral and/or intraventricular hemorrhage 5. singleton or twin gestation 6. no sensorineural hearing loss (at discharge, passed bilateral hearing screening) 7. free from necrotizing enterocolitis 8. free from severe retinopathy 9. no asphyxiated 11. no terms of surgical relevance 12. born from hiv negative and drug free mothers exclusion criteria, we will exclude infants whose mothers will be: 1. affected by drug dependence 2. affected by psychosis or other severe mental health problems 3. unable to adequately speak/understand italian language 4. younger than 18 years of age 5. physically unable to participate

Keywords: music therapy nicu preterm infants music hrv neurodevelopment
the evaluation of cellular and humoral immunity to covid-19 in moscow residents

Conditions: Covid19; Respiratory Viral Infection

Summary: the aim of the research is to estimate the levels of cellular and humoral immunity to the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) among moscow residents over 18 years old. during the study, participants will be divided into four groups: healthy volunteers; individuals recovered from coronavirus disease 2019 (covid-19) with different severity; individuals vaccinated against sars-cov-2; individuals who have had covid-19 concomitantly with comorbidities that characterized by the impact on the immune system (tuberculosis, chronic obstructive pulmonary disease, hiv infection, hematological neoplasia). for all participants included into the study peripheral blood will be collected and the titers of sars-cov-2 specific immunoglobulins m (igm) and immunoglobulins g (igg), frequencies of the t cells specific to nucleocapsid (n), membrane (m), and spike (s) proteins of sars-cov-2 in peripheral blood, as well as the fractions of virus specific t helpers and cytotoxic t cells will be estimated. for smaller cohorts of the participants in all groups the antibody titers and t cell response levels will be examined in dynamics. all participants will be monitored for the incidence of primary or repeated covid-19 for 1-2 years after inclusion in the study. based on the results of the study, the relationship between the formation of humoral and cellular immunity against covid-19, the duration of these types of immunity, as well as their individual contribution to protection against primary or secondary sars-cov-2 infection will be analyzed. additionally, data concerning patients recovered from covid-19 and having concomitant diseases will provide a valuable information that may help to understand in more details the mechanisms of the development of the sars-cov-2 specific immune response.


Eligibility criteria:
inclusion criteria: * residents of the moscow city (registered in moscow); * 18 years old or above; * signed informed consent. exclusion criteria: * citizenship of a foreign state; * refusal to sign the informed consent.

Keywords: covid19 t cell immunity virus-specific antibodies protective immunity flow cytometry elispot
efficacy study of vaginal mesh for prolapse

Conditions: Pelvic Organ Prolapse; Uterine Prolapse; Vaginal Prolapse; Cystocele; Rectocele

Summary: the primary aim of this double-blind, randomized clinical trial (rct) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.

minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction. unfortunately, safety and efficacy data have lagged behind the technical advancements. no randomized controlled trials of different vaginal apical suspension procedures have been reported. the use of synthetic vaginal mesh has evolved due to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. this trial will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery for vaginal stage ii-iv prolapse.

Eligibility criteria:
inclusion criteria: * woman \> 21 yrs * stage ii-iv vaginal prolapse * desires vaginal reconstructive surgery * able to complete study questionnaires and assessments * uterus \< 12 weeks size * available for 12 months follow-up exclusion criteria: * medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system. * current intermittent catheterization. * pregnancy or desire for future fertility. * presence of an adnexal mass. * shortened vagina or other known mullerian anomaly (e.g. uterine didelphys). * other laparoscopic or abdominal/pelvic surgery in the past 3 months. * known neurologic or medical condition affecting bladder function, e.g. multiple sclerosis, spinal cord injury. * need for concomitant surgery requiring an abdominal incision. * \< 12 months post-partum. * non-english speaking

Keywords: prolapse uterus pelvic organ vaginal prolpase
comparison of two nn1250 formulations versus insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe, oceania and the united states of america (usa). the aim of this trial is to compare two nn1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least one year * hba1c 7-11% (both inclusive) * treated with insulin for at least six months - any regimen exclusion criteria: * any systemic treatment with products which in the investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 months prior to randomisation * subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
platelet transfusions in critically ill patient

Conditions: Platelet Transfusion; Critical Illness

Summary: between 10 and 15% of critically ill patients require platelet transfusion within their intensive care unit (icu). platelets (plt) are given to prevent bleeding in thrombocytopenic patients or to treat bleeding as part of massive transfusion or in bleeding thrombocytopenic patients. international and local guidelines (american association of blood banks-aabb) are mainly based on experts' opinion. the efficacy of plt transfusion in the icu setting remains poorly studied and unknown and the administration of plt may be associated with adverse effects including an increased risk of hospital acquired infection. finally, the short plt shelve-life may be responsible for inventory issues. altogether, this makes very important to improve the evidence that support plt transfusion in icu patients. this is a multicentre prospective observational study that aims to first determine plt transfusion efficacy and to identify the parameters associated with transfusion efficacy and to analyse the compliance with international (and local) guidelines of plt transfusion in icu patients.


Eligibility criteria:
inclusion criteria: * patients admitted to intensive care and receiving at least one platelet transfusion in intensive care unit exclusion criteria: * age less than 18
skin hydration in persons with acne after dietary supplementation with botanical antioxidants

Conditions: Acne Vulgaris; Acne

Summary: antioxidants have been studied for their abilities to combat reactive oxygen species in a multitude of conditions. this study aims to assess whether the botanical dietary supplement 'halo beauty kiwi booster' (hbkb), taken orally daily for 8 weeks, can assist with acne vulgaris as well as skin hydration and quality of life for those with acne.

the study will be a 2-armed investigational trial with one group receiving botanical dietary supplement and one placebo group provided with the similar supplement vehicle. the trial will be double-blind, randomized, parallel-group study. the investigational group will receive the botanical dietary supplement 'halo beauty kiwi booster' (hbkb), to be taken orally daily for 8 weeks. control group participants will receive the hbkb botanical dietary supplement vehicle as a placebo to be taken orally daily for 8 weeks.participants will have their skin assessed

Eligibility criteria:
inclusion criteria: * adults 18-35 years of age able to provide consent to participate * iga of mild to moderately severe facial acne vulgaris (av) at screening * potential participants with mild to moderately severe facial av and with av on their neck, shoulders, chest and/or back body surface areas may be included. exclusion criteria: * an investigator global assessment iga of severe facial, neck, back or truncal av * diagnosis of a chronic inflammatory disease such as lupus, multiple sclerosis, cancer, chron's disease or cancer * allergies to astaxanthin (microalgae), grape seed extract, kiwi fruit or kiwi extract, pineapple fruit or extract (bromelain), rosehip or rosehip extract, gooseberry, rosehip, grapes * secondary av, such as occupational av, steroid induced av, or av associated with endocrine disorders * having facial dermatosis that may interfere evaluations by iga such as sunburn, eczema, psoriasis, erythematotelangectatic rosacea or seborrheic dermatitis * use of isotretinoin within 2 months * use of adapalene or tretinoin within 2 weeks * use of anti-biotics within 2 weeks * use of oral corticosteroids or androgens within 2 weeks * use of anticonvulsants * any subject who the pi deems unsuitable for any reason

Keywords: antioxidants acne
the minnesota manual dexterity test as a measure of hand function in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the aim of the study is to report the results of manual dexterity using the minnesota manual dexterity test in people with multiple sclerosis.

upper limb can be affected even in early stage in people with multiple sclerosis (pwms). manual dexterity is important to maintain upper limb function and 9-hole peg test (9hpt) is used as gold standard to assess dexterity in pwms. there are no studies evaluating manual dexterity with the minnesota manual dexterity test (mmdt) in pwms. this study aims to: 1. reporting the results of manual dexterity using the minnesota manual dexterity test and comparing the test results with healthy volunteers, 2. examining the relationship between mmdt and 9hpt, abilhand, grip strength, pinch strength, fatigue.

Eligibility criteria:
inclusion criteria: * (1) age 18-65; * (2) definitive diagnosis of ms according to mcdonald criteria; * (3) ability to read and write in turkish. exclusion criteria: * (1) acute attacks of ms (within 3 months); * (2) cognitive impairment (mini mental test result 24 points and below); * (3) having spasticity (3 and above according to modified ashworth scale) * (4) any chronic disease other than ms; * (5) being addicted to alcohol or drugs,

Keywords: multiple sclerosis upper limb manual dexterity assessment minnesota manual dexterity test
the study of probe-based confocal laser endomicroscopy of distal airways in diagnostics of lung diseases

Conditions: Inflammatory, Interstitial, Rare Lung Diseases

Summary: the study is devoted to the comparative analysis of the data received in patients with lung pathology using new method of probe-based confocal laser endoscopy of distal airways and two reference methods: high resolution computed tomography and morphology.

a relatively new technology in pulmonary medicine, probe-based confocal laser endomicroscopy of distal airways, which is also called alveoscopy, allows for real-time minimally invasive intraacinar imaging. this method has been developed that special miniprobe can be passed into the distal airway via the working channel of the bronchoscope and provide so called "optical biopsy". the method is based on the natural autofluorescence of pulmonary structures, detecting the elastin scaffold of central and peripheral airways, the structure of alveoli, blood vessels and alveolar macrophages. taking into account the fact that in vivo endomicroscopy of distal airways is a novel diagnostic technique it needs correlating the obtained data at certain disease with the reference methods for the challenges of our current understanding of interpreting endomicroscopic images. we choose high resolution computed tomography and morphology as such reference methods.

Eligibility criteria:
inclusion criteria: * patient informed consent; * patients' fitness; * the diagnosis of one of the following lung diseases: copd, pneumonia, solitary nodule, pulmonary sarcoidosis, idiopathic interstitial pneumonia, hypersensitivity pneumonitis, pulmonary vasculitis, pulmonary eosinophilia, hemochromatosis, histiocytosis x, pulmonary lymphangioleiomyomatosis; alveolar proteinosis, other rare lung disease * high resolution computed tomography scans performed not later than one month before pcle; * planned or performed histology exclusion criteria: * severe respiratory failure, * pregnancy or breast feeding, * lung bleeding, * any acute or chronic disease that may be a contraindication to bronchoscopy, * any significant blood coagulation disorder, * any diseases of hematopoietic system, * alcoholism or toxic addiction, * taking part in other clinical trials,

Keywords: alveoflex probe-based confocal laser endomicroscopy pcle alveoscopy morphology high resolution computed tomography
pilot study to assess the efficacy of short exposure to defocus to slow the progression of myopia in children

Conditions: Myopia

Summary: the objective of this pilot study is to establish whether brief periods of high levels of acutely imposed myopic defocus can be used to slow the progression of myopia in children, as measured by changes in spherical equivalent refraction and axial length.

recent results on animal models of myopia suggest that the eye has the ability to detect the overall sign of defocus of images falling on the retina, with myopic defocus imposed by the fitting of plus-lenses halting or slowing axial elongation of the eye. in the animal models, these stop growth signals have been shown to be particularly strong - with brief periods of high myopic defocus able to outweigh the effects of prolonged periods of imposed hyperopic defocus in promoting eye growth. these results therefore suggest a novel strategy for preventing the progression of myopia in children - the imposition of high levels of myopia for brief periods of time. this approach is conceptually distinct from under-correction, which imposes chronic mild myopic defocus.

Eligibility criteria:
inclusion criteria: 1. children aged 6 to 12 years 2. refractive error of spherical equivalent -1.00 d to -6.00d in each eye as measured by cycloplegic autorefraction 3. active myopia progression of at least spherical equivalent -0.50 d over the last 12 months as determined or suggested by refractive records or change in lens power 4. astigmatism of less than or equal to -1.50 d as measured by non-cycloplegic or cycloplegic autorefraction 5. distance vision correctable to logmar 0.1 or better in both eyes 6. normal intraocular pressure of not greater than 21 mmhg 7. normal ocular health other than myopia 8. in good general health 9. willing and able to comply with scheduled visits and other study procedures exclusion criteria: 1. baseline anisometropia of \> 1.5d 2. ocular or systemic diseases which may affect vision or refractive error 3. defective binocular function or stereopsis 4. amblyopia or manifest strabismus including intermittent tropia 5. previous or current use of atropine or pirenzepine 6. any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study 7. allergy to cyclopentolate, proparacaine and benzalkonium chloride

Keywords: myopia, defocus
a phase i study to assess the pharmacokinetics of olorofim in subjects with hepatic impairment

Conditions: Hepatic Impairment

Summary: a single oral dose study to investigate the pk and safety of olorofim in mild and moderately hepatically impaired subjects compared to subjects with normal hepatic function.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 to 70 years of age inclusive, at the time of signing the informed consent. * body weight ≥50 kg and bmi within the range 18 to 35 kg/m2 (inclusive * subjects with mild hepatic impairment will have grade a child-pugh score of 5 to 6 at screening and day -1: * subjects with moderate hepatic impairment: will have grade b child-pugh score of 7 to 9 at screening and day -1 * subjects with normal liver function must be in good health, as determined by a medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory evaluations * subjects with normal liver function are matched by gender, age (±10 years) and bmi (± 20%) to at least one hepatically impaired subject. exclusion criteria: * subjects who have an abnormality in the 12-lead ecg that, in the opinion of the investigator, increases the risk of participating in the study * subjects with any history of convulsion (other than childhood febrile convulsion before the age of 6 years). * subjects who have any clinically significant allergic disease (excluding mild or seasonal allergies such as contact dermatitis or hay fever) as determined by the investigator. * subjects with a history of or any concomitant active malignancy. * subjects with a history of drug or alcohol abuse. * subjects with, or with a history of, any clinically significant neurological, renal, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma), hematological, or other major disorders as determined by the investigator. * subjects with signs or symptoms consistent with a covid-19 infection at screening or day -1 * hepatically impaired subjects with liver transplantation, autoimmune liver disease, or drug-induced liver damage
efficacy and safety of ain457 (secukinumab) in patients with relapsing multiple sclerosis

Conditions: Multiple Sclerosis

Summary: to evaluate the efficacy and safety of ain457 versus placebo in patients with relapsing multiple sclerosis.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis according to 2010 revised mcdonald criteria * disease duration of 10 years or less * at least one relapse in the last year * edss score 0 to 5.0 at entry exclusion criteria: * active chronic disease of the immune system other than multiple sclerosis * history of malignancy within the past 5 years * active systemic bacterial, viral or fungal infections * previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s) * any medically unstable condition * unable to undergo mri scans or repeated blood tests * pregnant or nursing females * women of child-bearing potential must use reliable forms of contraception * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: multiple sclerosis relapsing multiple sclerosis ain457 secukinumab magnetic resonance imaging relapsing remitting multiple sclerosis autoimmune diseases nervous system diseases immune system diseases demyelinating diseases