Kornimate/medical-research-clean huggingface dataset:
expressive language and cognitive early development in very low birth-weight preterm toddlers

Conditions: Prematurity

Summary: the aim of the present study is to describe the performance of very low birth-weight preterm toddlers regarding expressive language and cognitive development during sensorimotor and beginning of pre-operational periods, as well as to compare the performance presented by these children to that presented by their full-term peers, according to genetic epistemology theoretical principles. the hypothesis of this study is that very-low birth weight preterms would present a poorer performance, concerning expressive language and cognition development,than their full-term peers.

very low birth weight preterm infants are known to have risks of cognitive and behavioral problems, including learning difficulties, attention deficits and hyperactivity, as well as neuromotor deficits. moreover, they are reported to have a high risk of speech and language impairments up to school age, even in cases where major neurological abnormalities are excluded. impairments have been reported both in receptive and expressive language and, more specifically, in morphosyntax and naming.

Eligibility criteria:
study group: inclusion criteria: * gestational age lower than 34 weeks (according to the date of last menstrual period - dlmp); * birth weight equal or lower than 1500g; * exposed only to brazilian portuguese exclusion criteria: * presence of major malformations, genetic syndromes, severe neonatal asphyxia, hearing impairment or visual impairment. control group: inclusion criteria: * gestational age higher than 38 weeks; * adequate for gestational age; * birth weight higher than 2500g up to 3999g * exposed only to brazilian portuguese exclusion criteria: * pre, peri or post natal intercurrence

Keywords: expressive language cognition early development very low birt weight prematurity
study of the efficacy and safety of ponsegromab in patients with cancer, cachexia and elevated gdf-15

Conditions: Non-small Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer; Loss of Appetite; Fatigue; Cachexia

Summary: study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated gdf 15.

a 12 week double blind study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated gdf 15. during the initial 12-week treatment period (part a), a total of 3 doses of ponsegromab or placebo will be administered 4 weeks apart subcutaneously. each dose contains two injections. part b is an optional open-label treatment period consisting of ponsegromab administered every 4 weeks subcutaneously for up to one year. part b does not include placebo. assessments include: * body weight measurements * measure the impact of ponsegromab compared to placebo on physical activity. * measure the impact of ponsegromab compared to placebo on appetite, fatigue, nausea, vomiting and physical function questionnaires. * blood samples to evaluate safety and additional endpoints including the amount of study drug in the blood and the effects of the study drug on levels of gdf15 * up to 3 additional blood samples (two samples during part a and one sample during part b, if relevant) in a subset of participants as part of a substudy for more comprehensive assessment of the amount of study drug in the blood and of the effects of the study drug on levels of gdf-15.

Eligibility criteria:
key inclusion criteria: * documented active diagnosis of non-small cell lung, pancreatic, colorectal cancer * cachexia defined by fearon criteria of weight loss * serum gdf-15 concentrations * signed informed consent * ecog ps ≤3 with life expectancy of at least 4 months to be able to complete part a. key exclusion criteria: * receiving tube feedings or parenteral nutrition at the time of screening or randomization. * current active reversible causes of decreased food intake. * cachexia caused by other reasons. * history of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody. * inadequate liver function * renal disease requiring dialysis

Keywords: cancer anorexia cachexia weight loss loss of appetite fatigue
the effect of healing touch on sleep

Conditions: Elective Reconstructive Surgery Population

Summary: healing touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.

patients are to randomized into one of 4 treatment groups upon enrollment. depending on randomization group, the study participant receives the treatment the evening before elective surgery. a polysomnographic sleep study is then completed. plan is to review the effect of the treatment group on sleep quantity and sleep quality.

Eligibility criteria:
inclusion criteria: 1. 5-25 years of age, inclusive 2. elective admission for a reconstructive operative procedure 3. planned use of general anesthesia during the elective operative procedure 4. written informed consent, assent and health insurance portability and accountability act (hipaa) release signed by parent or legal guardian exclusion criteria: 1. history of anoxic or suspected brain injury 2. history of head injury within the last year 3. pre-existing neurological disorder 4. history of reynaud's syndrome 5. intellectual disability or inability to follow directions 6. face/head phenomena that prevent(s) proper placement of polysomnography(psg) leads 7. taking medication for diagnosis of cardiomyopathy
three generic nevirapine-based antiretroviral treatments in chinese patients:multicentric observation cohort

Conditions: HIV Infections

Summary: the purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of acquired immune deficiency syndrome .


Eligibility criteria:
inclusion criteria: * 18 years or older * the subjects were hiv-seropositive by standard serum enzyme-linked immunosorbent assay (elisa) tests and also by western blot analysis * the subjects were antiretroviral drug-naïve * a baseline cd4+ t-cell count from 100 to 350 cells/mm3 and a baseline plasma viral load over 500copies/ml exclusion criteria: * pregnancy or breastfeeding * anticipated nonadherence * aids-defining illness within 2 weeks of entry * white blood cell count less than 2.0×109/l, absolute neutrophil count less than 1.0×109/l, hemoglobin level less than 90g/l, platelet count less than 0.75×1012/l * transaminase and alkaline phosphatase level more than 3 times the upper limit of the normal range, bilirubin level more than 2.5times the upper limit of the normal range, serum creatinine level more than 1.5 times the upper limit of the normal range

Keywords: acquired immunodeficiency syndrome adverse effects treatment outcome drug resistance, viral treatment naïve
blood changes after exercise in restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: the goal of this clinical trial is to learn how exercise changes molecules in the blood in people with restless legs syndrome (rls) to better understand the cause(s) of rls. the main questions the investigators aim to answer are: how does long-term exercise change proteins in the blood? how does a single exercise session change proteins in the blood? the investigators will compare long-term exercise to no exercise to see if the changes in proteins are specific to exercise. participants will complete an exercise test and provide blood samples before and after the exercise test. participants will be randomized (like the flip of a coin) in to either the exercise or no-exercise group for 12 weeks and then complete the exercise test and blood samples again at the end.


Eligibility criteria:
inclusion criteria: * age 18 years or older; * diagnosis of rls; * presence of moderate-to-severe rls (irls score\>15); * currently untreated rls; * being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months; * ability to walk without assistance (does not use a cane/walker/wheelchair for mobility; * willing to complete outcome measures and complete the exercise program exclusion criteria: * present with a condition that can mimic rls or cause secondary rls (e.g., iron deficiency anemia, radiculopathy, peripheral edema, peripheral neuropathy, diabetes); * are at moderate or high risk for undertaking strenuous or maximal exercise

Keywords: exercise proteomics
tau and connectomics in tes study

Conditions: Chronic Traumatic Encephalopathy; Traumatic Encephalopathy; Head Injury Trauma; Cognitive Impairment; Neurodegenerative Diseases

Summary: this pilot study aims to assess if participants that meet the criteria for a tes diagnosis have a specific tau deposition profile on pet scanning using the pet tau binding ligand - \[18f\] pi-2620. it is hoped this study will highlight potential diagnostic tests of tes diagnosis, the in-life correlate of cte.


Eligibility criteria:
inclusion criteria: * the participant must have full capacity to understand the purpose and risks of the study to provide informed consent. * all participants must be between 40 to 70 years of age. * must meet the traumatic encephalopathy syndrome criteria as defined by the national institute of neurological disorders and stroke consensus diagnostic criteria for traumatic encephalopathy syndrome, katz. d, et. al. neurology, 2021. * participants must demonstrate that they have a cognitive decline, evident by performance on neuropsychological testing. * standard of care blood screening within 12 months of consent to the study to exclude other medical conditions which may cause cognitive decline, such as heavy metal toxicology. * a pet scan within 6 months of consent to the study that is not consistent with alzheimer's disease. * participants must consent to undertake positron emission tomography (pet) with intravenous \[18f\] pi-2620 pet tracer ligand. * participants must be able to lie still, on their back for up to 60 minutes for the scans. * participants must not have any metal in their bodies e.g. pacemakers, aneurysm clips which are contraindications of mri. * participants must consent to the use of their medical records and medical history, including but not limited to pathology results, previous imaging results and neuropsychology results exclusion criteria: * participants will be excluded if they do not meet all the inclusion criteria. * participants must not be diagnosed with or suspected to be suffering from any other neurodegenerative disease, or cerebral disease affecting cognition as identified by results of neuropsychological evaluation or neurologist consultation. * participants will be excluded if staff at macquarie medical imaging determine that the participant is not suitable for imaging, for any reason. * participants will be excluded if they have kidney and/or liver dysfunction as diagnosed by a doctor
a phase 2b study of bnc210 tablet formulation in adults with post-traumatic stress disorder (ptsd)

Conditions: Post-Traumatic Stress Disorder

Summary: the purpose of this study is to assess the effects of bnc210 compared to placebo on post-traumatic stress disorder (ptsd) symptom severity as measured by the clinician administered ptsd scale for the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) (caps-5) total symptom severity scores.

this is a randomized, double-blind, placebo-controlled, parallel group, multi-center study with a 12 week, 2-arm treatment period. participants will attend a screening visit within 3 weeks before randomization to confirm eligibility. approximately 200 participants will be randomized using a 1:1 ratio to receive either bnc210 900 mg twice daily (b.i.d.) or matched placebo. participants will then complete 12 weeks of treatment with their allocated study intervention. participants will return to their study site at 2-weekly intervals to complete study assessments. participants are then requested to attend a follow-up visit at week 15 (i.e., 3 weeks after their last study intervention is administered).

Eligibility criteria:
inclusion criteria: * participants with a current diagnosis of ptsd as defined by the caps-5 for dsm-5, with a caps-5 total symptom severity score of ≥30 at screening and baseline and no \>25% decrease in score from screening to baseline * the index trauma event must have occurred in adulthood, i.e., when the participant was ≥18 years of age * suitable contraception use in line with protocol requirements * ability to swallow tablets exclusion criteria: * a period of less than 6 months since the index trauma event * current and ongoing exposure to the trauma that caused the ptsd * complex ptsd * severe depression as measured by a score of ≥ 35 on the montgomery asberg depression rating scale (madrs) * borderline personality disorder, bipolar disorder and other psychotic disorders * use of antidepressant medications within 30 days (fluoxetine within 90 days) of screening. the use of alprazolam, flunitrazepam and chronic daily use of other benzodiazepines within 90 day of screening. * failed more than three trials of antidepressant medication(s) prescribed for the treatment of ptsd. * concurrent trauma-based psychotherapy such as cognitive behavior therapy, prolonged exposure therapy, eye movement desensitization and reprocessing therapy. participants may however continue to receive supportive counseling that has been in place for a minimum of three months prior to screening. * any moderate or severe substance use disorder in the past 12 months * any clinically significant medical history or findings as determined by the investigator that could interfere with the objectives of the study or put the participant at risk
clinical investigation on assessing the repeatability and reproducibility of central and peripheral refractive error

Conditions: Refractive Error

Summary: this is a unilateral, non-interventional study. each subject will be unilaterally measured with the wam-5500 autorefractor by 3 testers. all measurements will be made on the right eye only.


Eligibility criteria:
inclusion criteria: potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. 2. appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. be between 18 and 50 (inclusive) years of age at the time of screening. 4. the spherical component of the subject's non-vertex-corrected distance subjective refraction must be between +1.50 and -6.00ds (inclusive), with the magnitude of the cylinder 2.00 dc or less in the right eye. 5. the subject must have a van herrick angle grade of at least 3 or greater in the right eye. 6. the subject must have a bscva of at least 20/30 (defined as reading at least 3 out of the 5 letters on the 20/30 line) in the right eye. exclusion criteria: potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. be currently pregnant or lactating. 2. be diabetic or pre-diabetic by self-report. 3. have a history of ocular trauma, systemic disease or medication use known to cause variability in refractive error. 4. have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, prk, lasik, iridotomy, retinal laser photocoagulation, etc.). 5. have habitually worn rigid gas permeable (rgp) lenses, orthokeratology lenses, scleral lenses, or hybrid lenses (e.g. synergeyes, softperm) within the past 3 months. 6. be an employee (e.g., investigator, coordinator, technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. 7. take ocular and systemic medications known to interact with tropicamide ophthalmic solution or systemic medications that can cause myopia. 8. have a history of an allergic reaction to tropicamide or proparacaine. 9. have clinically significant (grade 3 or higher on the fda grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities, or bulbar injection) or other corneal or ocular disease or abnormalities that may compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, corneal scar or opacity ≥ 0.3 mm, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). 10. have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 11. have a history of strabismus, amblyopia, nystagmus, or any condition that affects fixation.
comparison of optical coherence tomography angiography microvascular changes in primary open angle and primary angle closure glaucoma

Conditions: Glaucoma,Primary Open-Angle ,Primary Angle Closure

Summary: this work aims to study the peripapillary and macular microvascular changes in primary open angle and primary angle closure glaucoma using optical coherence tomography angiography (octa).

after approval of the local institutional ethics committee and local institutional review board, all patients presenting to the outpatient clinic of the department of ophthalmology in the universities has been subjected to routine ophthalmological examination including: best corrected visual acuity (bcva), slit-lamp evaluation of anterior segment, iop by goldmann applanation tonometer, gonioscopy using gonio contact lens, fundus examination by indirect opthalmoscope with history taking focusing on positive family history of glaucoma after a detailed informed consent was signed by eligible patients and investigated by octa of the peripapillary and macular vascular density on presentation using angivue (optovue, inc., fremont, ca, usa). data analysis performed using the statistical package of social science (spss) software version 22 in windows 7 (spss inc., chicago, il, usa) simple descriptive statistical analysis in the form of numbers and percentages of qualitative data, and arithmetic means as central tendency measurement, standard deviations as a measure of dispersion of quantitative parametric data. for quantitative parametric data: independent samples test was used to compare quantitative measures between two independent groups, one-way analysis of variance anova test used to compare quantitative measures between more than two independent groups of quantitative data with the benferroni post-hoc to test the significance between each two groups, paired t-test used to compare two dependent quantitative data. for qualitative data chi square test used to compare between two or more than two qualitative groups. bivariate pearson correlation test to test the association between variables the probability value (p-value) \< 0.05 was considered as statistical significant

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * fulfilling diagnostic criteria of pacg patients :occluded angle by gonioscopy in which \> 180˚ of trabecular meshwork cannot be seen , iop\>21, optic disc and rnfl damage due to glaucoma * diagnosed poag patient: open anterior chamber angle ,iop\>21 ,optic disc and rnfl damage due to glaucoma * healthy patient: normal anterior chamber, open angle and normal fundus. exclusion criteria: * history of other causes of optic neuropathy. * history of systemic diseases. (htn, dm, cardiac). * previous ocular surgeries or laser iridotomy. * poor quality of octa image less than 4/10. * refractive errors \> 6 diopters sphere, \>3 diopter cylinder * poor cooperation or fixation with the octa examination. * secondary causes of glaucoma * media opacity that interfere with quality of image (dense cataract,corneal opacity,...) * previous acute attack of acg
valsalva maneuver and control in reducing pain during spinal injection

Conditions: Brachytherapy

Summary: the study aimed to compare the effectiveness of valsalva maneuver as non pharmacological approach and control in reducing pain during spinal injection.

this was an experimental study on 70 subjects with 35 subjects treated with valsalva maneuver and 35 subjects treated as control from january to april 2019. research subjects were female who underwent brachytherapy for the first time with spinal anesthesia. the effectiveness in reducing pain was assessed by using visual analogue scale (vas) and patient movement during the surgery.

Eligibility criteria:
inclusion criteria: * patients underwent elective surgery using spinal anesthesia * patients who have not undergone spinal anesthesia before * physical status asa i or ii * signing informed consent exclusion criteria: * have a spinal anesthesia history * contraindicated for spinal anesthesia * subjects who cannot do valsalva to 30mmhg pressure for 20 seconds * have a allergic history to local anesthetics or opioid drugs

Keywords: valsalva maneuver control pain spinal injection
role of urinary sphingosine 1-phosphate as a biomarker for detrusor hyperactivity in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study aims to establish a link between urinary sphingosine 1-phosphate (s1p) levels and detrusor activity in multiple sclerosis (ms) patients. ms often involves urological symptoms, primarily overactive bladder. the gold standard for evaluation and treatment monitoring is invasive urodynamic testing. preliminary research at toulouse university hospital suggests urinary s1p levels may be a potential biomarker for detrusor activity in ms. this study aims to confirm this potential biomarker's utility.


Eligibility criteria:
inclusion criteria: * french residents enrolled in the social security system * patients diagnosed with multiple sclerosis (according to mcdonald 2017 criteria), whether receiving treatment or not * patients scheduled for urodynamic assessment as part of their management exclusion criteria: * pregnant or lactating females * patients under legal guardianship * untreated urinary tract infection at the time of inclusion * known anatomical subvesical obstruction known pelvic floor disorder urothelial carcinoma interstitial cystitis augmentation cystoplasty