Kornimate/medical-research-clean huggingface dataset:
phase ii study for safety and efficacy evaluation of imatinib mesylate in children with chronic myeloid leukemia (cml) philadelphia chromosome-positive (ph+)

Conditions: Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)

Summary: the purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of imatinib in children with cml ph+.


Eligibility criteria:
inclusion criteria: 1. diagnose: suspected cml (hematology and/or myelogram and/or immunophenotyping and/or leukocyte alkaline phosphatase \[lap\]) to be confirmed, after, by cytogenetic and/or molecular biology. obs: only cml ph+ newly-diagnose in chronic or accelerate phase; resistant cml ph+ to interferon α (inf-α), hydroxyurea and/or low-dose ara-c in chronic or accelerate phase; cml ph+ with cytogenetic relapse after bmt, that didn't use imatinib previously, in chronic or accelerate phase. 2. female patients of childbearing age, should have pregnancy test (blood βhcg) performed before treatment initiation. effective contraception must be used. pregnant women won't be included. 3. karnofsky and lansky scale: ≥40. 4. life expectation \> 8 weeks. 5. laboratory: renal function (serum creatinine ≤ 1,5 x uln and/or clearance ≥70 ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x uln, tgp \ 2 g/dl. 6. cns toxicity ≤ ii 7. cardiac function: normal ejection fraction. 8. signed icf by child legal responsible. exclusion criteria: 1. patient receiving any other tyrosine kinase inhibitor (tki). 2. pregnant patient or breastfeeding. 3. patient considered incapable to follow purposed treatment. 4. patients with molecular relapsed. 5. medications: * colony stimulating: it cannot be administered at least 1 week before treatment. * anticonvulsants: imatinib is metabolized by p-450 enzyme, thereby subject cannot receive drug that activates the p-450 system. the anticonvulsants allowed are valproic acid and benzodiazepines. * anticoagulants: the use of warfarin (marevan) is not allowed. if anticoagulant is needed, low-molecular-weight heparin (lmwh) can be used. avoid anticoagulants with platelets \< 50000. * inf-α 48h before d1. * hydroxyurea 24h before d1. * ara-c doses \>100 mg/m2 for 5-7 days, 14 days before d1. * anthracyclines, mitoxantrone or etoposide 21 days before d1. * any other chemotherapeutic agent 28 days before d1. * hematopoietic cell transplantation (hct) 6 weeks before d1.
brachial artery ultrasound imaging: a repeatability study

Conditions: Cardiovascular Diseases

Summary: the objective of the study is to define the analytical repeatability of quantifying flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using upper arm cuff occlusion.


Eligibility criteria:
inclusion criteria: 1. men and women, ≥18 years old 2. eastern cooperative oncology group/zubrod score performance status of 0, 1, or 2, determined within 7 days prior to fmd testing on study day 1 (visit 1) 3. written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study exclusion criteria: 1. body mass index (bmi) \>50 kg/m2 2. mid-upper arm circumference of arm selected for fmd testing \ 42 cm 3. sinus arrhythmia (rr intervals vary by \>50%), atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ecg with rhythm strip at the time of subject screening. 4. clinical signs and/or symptoms of active viral or bacterial infections 5. resting tremor or inability to remain still for the duration of the testing period 6. systolic blood pressure (sbp) at rest of \>170 mmhg or diastolic blood pressure (dbp) at rest of ≥110 mmhg. 7. diabetic subjects - type i or ii 8. previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Keywords: brachial artery ultrasound imaging flow-mediated dilation endothelium
prospective clinical assessment study in children with hypochondroplasia

Conditions: Hypochondroplasia

Summary: this is a long-term, multicenter, non-interventional study of children ages 2.5 to \<17 years with hypochondroplasia (hch).

the objective is to evaluate growth, hch-related medical complications, health-related quality of life, functional abilities and cognitive functions of study participants. data collected will contribute to the characterization of the natural history of children with hch. no study medication will be administered.

Eligibility criteria:
inclusion criteria: signed informed consent. aged 2.5 to \<17 years at study entry. diagnosis of hch documented clinically by the presence of disproportionate short stature and confirmed with a molecular test. participants are ambulatory and able to stand without assistance. study participants and parent(s), guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures. exclusion criteria: have ach or short stature condition other than hch. in females, having had their menarche. annualized height growth velocity ≤1.5 cm/year over a period ≥6 months prior to screening. having a clinically significant disease or condition that in view of the investigator or sponsor will interfere with the evaluation of growth, with study participation or not be in the best interest of the participant. clinically significant abnormality in any laboratory test result at screening have been treated with growth hormone, igf 1, or anabolic steroids the previous 6 months or long-term treatment (\>3 months) at any time. current evidence of corneal or retinal disorders. have used any other investigational product or investigational medical device for the treatment of hch or short stature. have had regular long-term treatment (\>1 month) with oral corticosteroids (low-dose ongoing inhaled steroid for asthma is acceptable). previous limb-lengthening surgery or guided growth surgery with plates still in place or removed within the 6 months prior to screening. having had a fracture of the long bones or spine within 12 months of screening. history and/or current evidence of extensive ectopic tissue calcification. history of malignancy. concurrent circumstance, disease, or condition that, in the view of the investigator and/or sponsor, would interfere with study participation, and/or would place the participant at high risk for poor compliance with study activities or for not completing the study.

Keywords: skeletal dysplasia endochondral ossification hypochondroplasia hch shortened proximal limbs fibroblast growth factor receptor 3 fgfr3 endochondral bone formation disproportionate short stature quality of life dwarfism bone diseases musculoskeletal diseases osteochondrodysplasia functional abilities annualized growth velocity annualized height velocity growth genetic diseases congenital ahv agv
a double blind, randomized, controlled study to evaluate chf 5633 (synthetic surfactant) and poractant alfa in neonates with respiratory distress syndrome (rds) (poc)

Conditions: Respiratory Distress Syndrome, Newborn

Summary: a multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (chf 5633) in comparison to porcine surfactant (poractant alfa, curosurf ®) in the treatment of preterm neonates with respiratory distress syndrome. main objectives of this study are to investigate the short term efficacy profile of chf 5633 vs. porcine surfactant (poractant alfa, curosurf®) in terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (bpd) and mortality/bpd rate at 36 weeks post menstrual age (pma), mortality rate at 28 days and 36 weeks pma, rds-associated mortality through 14 days of age and other major co-morbidities of prematurity. inclusion criteria are: written parental informed consent, inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with rds, requirement of endotracheal surfactant administration within 24 hours from birth, fraction of inspired oxygen (fio2) ≥0.30 for babies 24+0 to 26+6 weeks and fio2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain arterial oxygen saturation by pulse oximetry (spo2) between 88-95%.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures 2. inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks 3. clinical course consistent with rds 4. requirement of endotracheal surfactant administration within 24 hours from birth 5. fraction of inspired oxygen (fio2) ≥0.30 for babies 24+0 to 26+6 weeks and fio2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain spo2 between 88-95% exclusion criteria: 1. use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide) 2. known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc) 3. maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy 4. mothers with prolonged rupture of the membranes (\>21 days duration) 5. strong suspicion of congenital pneumonia/infection, sepsis 6. presence of air leaks prior to study entry 7. evidence of severe birth asphyxia 8. neonatal seizures prior to study entry 9. any condition that, in the opinion of the investigator, would place the neonate at undue risk 10. participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol.

Keywords: neonates, pulmonary surfactant
dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth

Conditions: Neonatal Complications

Summary: extensive animal studies have indicated that antenatal betamethasone exposure results in altered developmental trajectories of several fetal systems. follow up of a randomized controlled trial has shown that antenatal betamethasone exposure might result in insulin resistance 30 years later. furthermore, animal studies and randomized trials in humans have clearly demonstrated that betamethasone-induced growth alterations were dose-related. in ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung function, similar to those obtained after a full dose. our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the potential long term effects of this drug, is not inferior to a full dose to promote fetal lung maturation in humans.

the betadose project consist in a randomized, multicenter, double blind placebo-controlled non inferiority trial comparing a standard dose regimen (24 mg) to a reduced dose regimen (12 mg) of betamethasone given to prevent the neonatal complications associated with very preterm birth.a betamethasone course consists in 2 injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. the first injection will be unmasked in both group. in both group, women will receive a first 12 mg injection of betamethasone according to local protocols. randomization will be performed after the first injection. women will then receive either a placebo injection (reduced dose regimen, 12 mg only from the first injection) or a second 12 mg betamethasone injection (standard dose regimen, 12 mg from the first injection and 12 mg from the second injection=24 mg). this protocol allows women sent from level 1 and 2 to level 3 perinatal centers after having already received their first injection to participate. in case of multiple antenatal betamethasone courses, women will receive their second course according to the same design as in their first course.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * patient having receipt the first injection of betamethasone and pregnancy term \< 32 weeks of gestation * age \> 18 years * patient affiliated to a social security regime exclusion criteria: * chromosomal aberrations and major fetal malformations * cervical dilatation ≥ 4 cm and of cervical length ≥20mm. * patient who have already received a first course of betamethasone * first intravenous injection of betamethasone
pc-based cognitive rehabilitation for traumatic brain injury (tbi)

Conditions: Traumatic Brain Injury

Summary: the investigators evaluated whether it was possible to improve the measurement of memory, attention, and executive function in patients who have suffered traumatic brain injury through the use of computer-based testing. note: the original design of the study was altered due to failure to recruit sufficient numbers of patients who were willing to undergo prolonged cognitive training.

here we describe a series of computer-based tests that were used to evaluate memory, attention, and executive function in large groups of control subjects and in patients with chronic mild and moderate/severe tbi. this extensive battery of neuropsychological tests (npts) and subjective rating scale measures were obtained at study entry from the tbi cohort. npt and rating scale data were compared to those obtained from control subjects to characterize the cognitive deficits following mild, moderate and severe tbi. . normative data were obtained by regressing the influences of age, education, and computer use on scores to create normed z-scores on different npts,. we hypothesized that patient with tbi would show deficits on tests of memory, attention, and executive function relative to their predicted z-scores (based on the aforementioned regression functions) and that deficits would be more pronounced in patients with severe tbi than in patients with mild tbi.

Eligibility criteria:
inclusion criteria: control subjects were required to meet the following inclusion criteria: * (a) fluency in the english language * (b) no current or prior history of bipolar disorder, mania, or schizophrenia * (c) no current substance abuse * (d) no concurrent history of neurologic disease known to affect cognitive functioning * (e) on a stable dosage of any required medication * (f) auditory functioning sufficient to understanding normal conversational speech and visual acuity normal or corrected to 20/40 or better exclusion criteria: * history of tbi exclusion criteria for tbi patients: * tbi patients had to meet the same inclusion criteria as the controls with the exception that they were required to have a history of tbi. they also had to be in the chronic phase, i.e., 1-4 yrs post-injury. * exclusion criteria: * current substance abuse * current psychiatric diagnosis other than ptsd

Keywords: cognitive training neuroplasticity cognitive impairment recovery of function memory attention
observatory on impact of life styles on health outcomes

Conditions: Outcome

Summary: the present is an observational study conducted on the general population in villages of southern italy every year during the world hypertension day. so far, a total of 412 persons (193 males and 219 female, 14-85 years) were recruited during the xi and xii world hypertension day (2015 and 2016). the study was approved by the relevant institutional ethical committee of salerno university.

in occasion of the world hypertension day in may , boots are organized in the major squares of the southern italy villages, and volunteers of the medical school of salerno collect through means of questionnaires, anamnestic data and dietary habits, and measure blood pressure after 5 minutes in the sitting position, 3 times with an interval of 2 minutes using validated, esh approved electronic oscillometer (a100, microlife, italy), according to the esc/esh guidelines. other questions regard previous cardiovascular conditions or events (coronary heart disease) and cardiovascular accidents (tia and stroke). eventual drug treatment and vitamin d supplementation is also annotated. a venous blood sample is drawn from the antecubital vein and blood is stored for biochemical analysis at the university hospital centralized service. data are digitally stored for analysis. anamnestic and biochemical data regarding age, sex-specific cholesterol, hdl cholesterol, systolic bp and cigarette smoking pre-existing conditions and way of life are used for the calculation of cardiovascular risk according to the framingham cardiovascular risk score. familiarity for cardiovascular disease is defined as cardiovascular events in parents and siblings less than 50 years old. the validated questionnaire alternate mediterranean diet score (amed), is administered to assess adherence to the mediterranean diet . laboratory assessment of blood samples. a venous blood sample was collected in two tubes of 5.0 ml and centrifuged in the day. the time of the last meal was recorded during the data collection. blood glucose, insulin, blood urea nitrogen (bun), creatinine, calcium, phosphorus, total cholesterol, hdl cholesterol, ldl cholesterol, triglycerides, 25(oh)d, pth, vitamin b-12 and folic acid are assessed. glomerular filtration rate (gfrs) is estimated using the equation of chronic kidney disease epidemiology collaboration (ckd-epi) .

Eligibility criteria:
inclusion criteria: - general population exclusion criteria: * subjects who do not sign informed consent and do not give authorization will be excluded from the study * subjects fed through parenteral feeding

Keywords: diet; exercise; hypertension; vitamin d
crispr-edited allogeneic anti-cd19 car-t cell therapy, in patients with refractory systemic lupus erythematosus (gallop)

Conditions: Systemic Lupus Erythematosus; Lupus; Lupus Erythematosus; Lupus Nephritis

Summary: this is a phase 1 study to evaluate the safety and efficacy of a single infusion of cb-010 in patients with refractory systemic lupus erythematosus (sle) with cohorts for lupus nephritis (ln) and extrarenal lupus (erl).

participants enrolled can expect to be on the study for a total duration of approximately 2 years, during which there will be a screening period followed by a single administration of cb-010 and then 24 months of safety follow-up and monitoring.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sle according to 2019 eular/acr classification criteria for at least 6 months * cohort 1 ln: 1. class iii or iv lupus nephritis 2. urine protein-to-creatinine ratio (upcr) ≥ 0.8 mg/mg 3. refractory to glucocorticoids and at least 2 immunosuppressive therapies * cohort 2 erl (patients with class i and ii ln may be included in the erl cohort if their sledai-2k is ≥ 8): 1. sledai-2k ≥ 8 2. refractory to glucocorticoids, and at least 2 immunosuppressive therapies * adequate renal, hepatic, pulmonary, and cardiac function, with specific laboratory criteria * females must be either of nonchildbearing potential, defined as postmenopausal or surgically sterile or agree to use a highly effective double barrier method of contraception or vasectomized partner exclusion criteria: * has active severe central nervous system (cns) lupus in the previous 3 months from planned ld start date * has received any other investigational treatment for any indication within the 4 weeks or 5 half-lives * prior treatment with cellular therapy (genetically modified cells), gene therapy directed at any target, allogenic or autologous stem cell transplant or organ transplant * history of infection with human immunodeficiency virus or evidence of hepatitis b or c virus infection * history of hypersensitivity to cyclophosphamide, fludarabine, or any of the components of cb-010 * received a live vaccine ≤ 6 weeks prior to start of ld * patients for whom magnetic resonance imaging (mri) studies are contraindicated or who cannot tolerate them

Keywords: cb-010 lupus nephritis lupus extrarenal lupus autoimmune disease anti-cd19 car-t therapy cell therapy
predictive factors for covid-19 in rheumatology

Conditions: Rheumatic Diseases; Covid19

Summary: we seek to study the behaviour of coronavirus infection in patients with rheumatological and/or autoimmune comorbidities, understood as a particular pathophysiological universe with its own risks and eventual benefits, until now fully hypothetical to be confirmed by means of real and recent evidence. on march 12, 2020, an initiative called the global alliance for covid-19 in rheumatology (the covid-19 rheumatology alliance) arises, as a rapid response of international coordination whose ultimate goal is to serve as help or guideline for all those doctors who seek be faced with receiving, evaluating, understanding and caring for a patient with rheumatological and / or autoimmune diseases in relation to the imminent risk of covid-19.

within this context, this study seeks to use the information registered by the fundación santa fe de bogotá university hospital as a participating centre. it is intended, under a prospective cohort methodology, to identify, analyze and compare predictive factors of the clinical course of covid-19 in patients with baseline diagnoses of rheumatological or autoimmune diseases with the intention of establishing well-founded parameters that contribute to the improvement in terms of strategies of prevention, management and prognosis; benefiting both directly treating physicians and patients, as well as indirectly a health system that is predicted to be pushed to the limit as time passes.

Eligibility criteria:
inclusion criteria: * older than 18 years. * have a diagnosis of a rheumatological disease and / or an autoimmune disease by meeting its own and standardized classification criteria. * confirmed diagnosis of covid-19 by rt-pcr test * being a patient at the fundación santa fe de bogotá university hospital. * be enroled in the registry of the global alliance for covid-19 in rheumatology. exclusion criteria: • loss of follow-up due to referral to an institution other than the fundación santa fe de bogotá university hospital, before documenting the outcome of his clinical picture.
wide scale monitoring for acute respiratory infection using a mobile-based study platform

Conditions: Covid19; Influenza; Respiratory Tract Infections; Acute Respiratory Tract Infection; Acute Respiratory Distress Syndrome

Summary: this is a prospective observational study using a mobile study platform (app) that is designed for use on android phones. study participants will provide baseline demographic and medical information and report symptoms of respiratory infection on a weekly basis using the app. participants will also report use of prevention techniques on the weekly survey. mobility data will be collected passively using the sensors on the participant's smartphone, if the participant has granted the proper device permissions. the overall goals of the study are to track spread of coronavirus-like illness (cli), inﬂuenza-like illness (ili) and non-speciﬁc respiratory illness (nsri) on a near-real time basis and identify speciﬁc behaviors associated with an increased or decreased risk of developing these conditions.


Eligibility criteria:
inclusion criteria: * adult 18 years or older, android mobile phone user, resides in the united states (has a us home address) exclusion criteria: * under the age of 18, does not use an android mobile device, opts out of sharing mobility data, does not live within the united states