Kornimate/medical-research-clean huggingface dataset:
auditory profile and language development in children operated for cleft palate

Conditions: Deafness

Summary: observational study about children with cleft palate from surgery to pre-adolescence :description of language development and hearing profile.

"children with cleft palates are prone to complications that can impact on their overall development. several factors such as serous otitis media or abnormal musculature of the velum can have consequences on hearing and language. in this context, it seems important to describe the evolution of this disease after surgery to better anticipate complications and improve their subsequent management. the aim of this study is to describe the hearing profile and language development of children with cleft palate from surgery to pre-adolescence. the hearing profile is assessed though an audiogram once or twice a year during the annual follow-up with the referring surgeon. language development is assessed by the intelligibility scale, a validated questionnaire. this study will allow identification of : - predictive criteria for poor hearing and poor language development; - risk groups: type of cleft, medical history, genetic background, etc; - level of speech disorder other than intelligibility: rhinolalia, eagerness for communication; - other factors in the history of the disease: âge at surgery ; - history of chronic otitis media, ventilation tube placements; - nasalization and language disorder; - speech-language pathology; - history of hearing impairment; - age of first words; - other ent clinical history; - history of malformations; - socio-economic level of the household; - mother's language / number of languages spoken at home. this is a retrospective and prospective cohort study. children aged 5 to 11 with a cleft palate operated on for a veloplasty at robert debré hospital between 2008 and 2014 were included in the study between 2008 and 2014. "

Eligibility criteria:
inclusion criteria: * children aged 5 to 11 years old operated on for a veloplasty at the robert debré hospital * operated between 2008 and 2014 * having a cleft veil with or without a cleft lip and palate exclusion criteria: * children operated on for primary veloplasty outside the robert debré hospital, and coming for secondary veloplasty. child operated on for a veloplasty for a cause other than the velar cleft.
deciphering the role of dietary fatty acids on extracellular vesicles-mediated intercellular communication

Conditions: Obesity; Metabolic Syndrome; Metabolic Disorder; Inflammation; Immune System and Related Disorders

Summary: dietary interventions have been consistently proposed as a part of a comprehensive strategy to lower the incidence and severity of atherosclerosis and coronary vascular disease. excessive comsumption of fats enriched in saturated fatty acids (sfas) is associated with an increased risk of atherosclerosis and other cardiovascular diseases (cvd). in contrasts, replacement of sfas with monounsaturated fatty acids (mufas) and omega-3 long chain polyunsaturated fatty acids (ω3-lcpufas) has been reported to be inversely associated with risk of atherosclerosis. this is partly due to the ability of mufas (and ω3-lcpufas) to modulate lipoprotein composition, oxidation state, and consequently their functionality, among others. while most of the nutritional studies have focused on elucidating the mechanisms by which dietary fats affect lipoprotein particles, little or nothing is known about the regulatory effect of dietary fatty acids on extracellular vesicles (evs). evs are small phospholipid particles that convey molecular bioactive cargoes and play essential roles in intercellular communication and, hence, a multifaceted role in health and disease. for the first time, the purpose of this project is to establish whether the type of major fatty acids present on a diet (sfas, mufas, or ω3-lcpufas) may alter the structure, cargo, and functionality of postprandial- and long-term-evs. in the precision nutrition era, the investigators expect to offer a new insight on evs and their relationship with dietary fatty acids through the following objectives: 1) to map changes in the lipidome, proteome, microtranscriptome, and functional properties of circulating evs in healthy subjects and patients with metabolic syndrome (mets) both at fasting and at postprandial state upon a challenge of a meal rich in sfas, mufas, and ω3-lcpufas; 2) to analyse the contribution of postprandial triacylglyceride-rich lipoproteins (trl) on evs-mediated intercellular communication in a fatty acid-dependent manner; and 3) to determine the influence of diets rich in sfas, mufas, and ω3-lcpufas on evs in an animal model of atherosclerosis in the setting of mets. collectively, this project will provide fundamental insight into ev biology, and remarks the clinical and functional relevance and divergent consequences of dietary fatty acids in health and disease.


Eligibility criteria:
inclusion criteria: • clinical diagnosis of metabolic syndrome exclusion criteria: * allergy to dairy products * allergy to fish oil * vegetarian * tobacco smoker * current or recent (\<4 wk) use of fish oil supplements or more than four times fish/week * received innoculations within 2 mo of starting the study or planned to during the study * donated or intended to donate blood from 2 mo before the study till 2 mo after the study * unstable body weight (no weight gain/loss \>3 kg)
flow cytometry applied to the diagnosis of peri-anaesthesic reactions

Conditions: Allergy

Summary: to assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to neuro-muscular blockers and to the determination of the neuro-muscular blocker (nmb) which may be used for an ulterior anaesthesia in case of allergy to one given nmb.

the flow cytometric protocol used for this study, was based on basophil selection by an anti- ccr3 and the analysis of basophil activation by the respective up and down regulation of the cd63 and ige markers as described previously. basophil activation was expressed in percentage cd63 expression on activated basophils and in activation index involving ige and cd63 markers and calculated by a specific algorithm developed by our group.. our aim is to test a sufficient number of patients in order to be able to establish the roc curves related to the allergen type tested and validate the use of an allergen mixture (nmb mix containing the 7 usual nmb at the optimal activation concentrations). patients will be included during the post-anaesthetic consultation on the basis of the diagnosis of an ige dependant per-anaesthetic reaction. the allegro-anaesthetist diagnostical habits won't be changed.

Eligibility criteria:
inclusion criteria: * patients aged at least 18 years, * patients having experienced an ige dependant per-anaesthetic reaction * affiliated to a social security exclusion criteria: * patients having taken anti-histamine drugs and corticoids during the last 8 days * patients submitted to a juridical protection

Keywords: 1allergy 2 neuromuscular blockers
assessment of n-acetylcysteine as therapy for myalgic encephalomyelitis/chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

Summary: chronic fatigue syndrome/myalgic encephalomyelitis (me/cfs) is an unexplained multisymptom/multisystem disorder for which there are currently no validated treatments. the present exploratory clinical trial aims to advance our understand of the mechanisms of in situ gsh synthesis control through assessment of the response of brain gsh and plasma markers of oxidative stress to different doses of nac in comparison to placebo, as a potential treatment for me/cfs that would provide neuroprotection against oxidative stress by restoring cortical gsh reserves. if successful, this exploratory clinical trial would address a significant public health concern by shedding new light onto the mechanisms of action of nac in brain gsh restoration, which could open a new avenue for the development of potentially effective treatments for a disorder, me/cfs, that currently has none.

this phase two, single-site study will utilize a double-blind, placebo-controlled, randomized, pre-/post-treatment design to investigate the effect of nac dosing on brain gsh levels and measure temporally concordant plasma levels of several established circulating markers of oxidative stress. three study groups, of 20 subjects each (for a total of 60 who completed all components of the study), will each be administered a different dose (0 mg/day, 900mg/day, 3600mg/day) of the study intervention over a four week period; n-acetylcysteine (nac) treatment. subjects receiving 0 mg/day dose will be administered a placebo. baseline visit assessments will include blood collection, survey questionnaires, mri and mrs imaging. subjects whose initial screening confirms low gsh level at baseline will be provided with a 4-week supplement of anonymized nac or placebo caplets. after 4 weeks, subjects will then undergo a follow-up visit to repeat the baseline assessments.

Eligibility criteria:
inclusion criteria: * males or females, ages 21 to 60 years (inclusive). * baseline gsh levels at or less than a predefined cutoff value. * primary diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (me/cfs). * willing and capable of providing informed consent. exclusion criteria: * significant and/or comorbid axis i (especially mood and anxiety) and axis ii disorders. * any significant neurological illness or impairment. * other unstable medical conditions (asthma, hypertension, endocrine or metabolic disease, etc). * history alcohol abuse. * positive urine toxicology at screening and on days of assessments. * positive pregnancy test at screening or on days of assessments. * contra-indication for clinical mri scan (e.g., pacemaker, metallic prosthesis). * baseline gsh levels higher than a predefined cutoff value.
false safety behavior elimination therapy: a randomized study of a brief individual transdiagnostic treatment for anxiety disorders

Conditions: Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder

Summary: the aim of the current study was to test the efficacy of an individually administered, brief (5-session) transdiagnostic treatment for anxiety disorders. the current treatment (called f-set) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive strategies (so-called "safety" aids) among individuals suffering from a range of anxiety disorders including generalized anxiety disorder (gad), social anxiety disorder (sad) and panic disorder (pd). we hypothesized that the f-set protocol would produce better overall outcome relative to a waitlist control.

the aim of the current study was to test the efficacy of an individually administered, brief (5-session) transdiagnostic treatment for anxiety disorders. the current treatment (called f-set) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive strategies (so-called "safety" aids) among individuals suffering from a range of anxiety disorders including generalized anxiety disorder (gad), social anxiety disorder (sad) and panic disorder (pd). four primary hypotheses were evaluated in the current study: (1) the f-set protocol would produce better overall outcome relative to a waitlist control, (2) the f-set protocol would yield clinically significant improvement of primary diagnosis symptoms as well as secondary diagnosis symptoms, (3) the f-set protocol would create treatment improvement that is maintained during a 1 month follow-up interval and (4) given that reduction of safety aid use is the key mechanism of change in the f-set treatment, a reduction in safety aid use will mediate the relationship between pre and post treatment.

Eligibility criteria:
inclusion criteria: * participants must have a primary diagnosis of panic disorder, generalized anxiety disorder, or social anxiety disorder. * no change in medication type or dose during the 12 weeks prior to treatment exclusion criteria: * current or past schizophrenia, bipolar disorder, or organic mental disorder

Keywords: transdiagnostic treatment cognitive behavior therapy anxiety panic disorder generalized anxiety disorder social anxiety disorder
reliability and validity study of urdu version of oxford knee score in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: * to translate the oxford knee score into urdu language * to evaluate the reliability and validity of urdu version of oxford knee score for accessing pain and physical function in patients with knee osteoarthritis. * to evaluate the correlation of oxford knee score with western ontario mcmaster universities osteoarthritis index and international knee documentation committee

the original english version of oxford knee score will be translated and culturally adapted as per previous recommendation. in patients with knee osteoarthritis, urdu version of oxford knee score will be distributed among 100 participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. to test reliability of inter/intra observer of ultimate final urdu version of oxford knee score will be filled from patients on the equivalent day, by 2 different bystanders, and for inter observer valuation, with an interval of 30 minutes between the first and second application. third assessment will be carried out after 7 days of the observer -1, for intra-observer assessment. data will be entered and analyzed cronbach alpha value. test-retest reliability will be assessed using an intra-class correlation coefficient. urdu version of oxford knee score will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility criteria:
inclusion criteria: * diagnosed knee osteoarthritis patients were included * both male and female patients were included * both unilateral and bilateral knee osteoarthritis patients were included * patients were included who fulfilled the american college of rheumatology criteria * patients were included between the age of 35-80 y old patients exclusion criteria: * patients with any heart problem were excluded * patients with peripheral vascular injury were excluded

Keywords: oxford knee score urdu version reliability validity knee osteoarthritis
linking hospitalized injection drug users to buprenorphine

Conditions: Opiate Dependence

Summary: this study tests whether starting suboxone (buprenorphine) during a medical hospitalization, and then providing an appointment (a "link") for after discharge to maintenance buprenorphine in an outpatient setting will reduce hiv risk behavior in individuals who inject opioids.

in this randomized controlled trial, medically hospitalized opioid dependent patients will be assigned to a "treatment as usual" group, where they will receive a detox regiment of suboxone during their hospital stay, or a "linkage" group, where they receive a maintenance course of suboxone during their hospital stay, and appointment post-discharge with an outpatient suboxone clinic/provider and a suboxone prescription to use between discharge and this appointment. study interviews are completed at baseline, and 1, 3- and 6-months post-baseline. primary outcomes are opioid use and hiv risk behavior.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * current opioid injector, at least weekly in the past month * current opioid dependence, scid confirmed * currently receiving an inpatient buprenorphine detoxification protocol. exclusion criteria: * patients unable to be interviewed due to acute illness or cognitive impairment * in police custody, expecting incarceration * persons who cannot provide two contact persons (including shelters, parole officers, etc.) to verify location * not able to complete assessments in english * enrolled in a methadone maintenance program * plans to leave the area within the next 6 months.

Keywords: opioid dependence suboxone hiv risk behavior
effects of a nurse-delivered cognitive behaviour therapy on adherence and depressive symptoms in hiv infected persons of south korea

Conditions: HIV Infections

Summary: cognitive behaviour therapy (cbt) has repeatedly been found to effectively treat depression in adult populations, and cbt for adherence and depression (cbt-ad) is an effective treatment for improving depressive symptoms and medication adherence in the context of various chronic health conditions, including hiv-infection. however, the effects of cbt have not been evaluated in south korea. even though hiv infection is currently a controllable disease for patients on successful antiretroviral therapy, people living with hiv (plwh) are still suffering from internal and external stigmatization in many asian countries, including south korea. it is not clear whether cbp-ad would be successful intervention among asian countries with cultural background of strong stigmatization on hiv/aids. we plan to do survey on facilitators or barriers to patients and providers to identify significant contextual factors in south korea. demographic data and clinical data including cd4+ t cell counts, viral loads, and antiretroviral therapy regimens will be collected, as well. specialists such as psychiatrist or clinical psychologist would be the best provider for cbt intervention. however, an effective and feasible therapy model should be integrated into primary hiv care in south korea. medical personnel within most hiv clinics in south korea include infectious diseases doctors, clinical nurses, and counselling nurses, but cbt services from psychiatrist or clinical psychologist are not routinely available in many hospitals. hospital-based counselling services with experienced nurses have been provided in many hiv clinics in south korea, and the counselling nurses would be feasible providers for cbt intervention of this study. so, we plan to investigate the effects of a nurse-delivered cognitive behaviour therapy.


Eligibility criteria:
inclusion criteria: 1. hiv(+) koreans, using art 2. adult (19+ years) 3. having self-reported depressive symptoms or self-reported adherence\<90% 4. being fluent in korean exclusion criteria: 1. suicidal ideation 2. active psychosis 3. uncontrolled neurological problem 4. having been initiated on or had their dose of psychotropic medication altered within the past 3 months 5. currently receiving psychotherapy for depression 6. having previously received cbt
study evaluating the effect of ima-638 in subjects with persistent asthma

Conditions: Asthma

Summary: primary purpose is to assess if ima-638 is safe and improves asthma in subjects with persistent asthma.


Eligibility criteria:
inclusion criteria: * generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg. * history of treatment with a medium to high dose of inhaled corticosteroids (ics), with or without long-acting beta-agonists (laba), for at least 2 months prior to the screening visit and must remain constant during the study. * fev1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in fev1 (l) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%. exclusion criteria:
randomized study of abc-14 regimen compared with "3+7" standard induction therapy or ab-14 for nd aml

Conditions: Acute Myeloid Leukemia

Summary: to compare the efficacy and safty of abc-14 regimen with the traditional "3+7" regimen or ab-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia

acute myeloid leukemia (aml) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.in the past 50 years, the "3+7" induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed aml patients with intensive chemotherapy. in aml patients \<60 years old, the "3+7" regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.

Eligibility criteria:
inclusion criteria: 1. diagnosed with aml (the diagnostic criteria refer to who2022 standard, non-apl), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine and other tumor reduction pretreatments); 2. age ≥18 years old; 3. ecog≤4; 4. the fertile woman agrees to use effective contraception during the treatment period and up to 3 months after the end of the treatment; sign the informed consent form. exclusion criteria: 1. known history of allergy to the investigational drug; 2. resistance to azacytidine, azacitidine, venetoclax; 3. inability to take oral medication; 4. combined with uncontrolled active infections (including bacterial, fungal or viral infections); 5. combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.; 6. participating in other clinical studies that affect the main purpose of this study; patients deemed unsuitable for participation in this study.

Keywords: abc-14 regimen "3+7" regimen ab-14 regimen
th1/th2/th17/treg and tlrs activation/kir for covid 19 prediction of outcome

Conditions: Disease, Viral; Cytokine Release Syndrome; TLRs

Summary: to ascertain globally the changes in the cytokines involved and tlrs/kir activation in patients admitted to the hospital with a covid-19 diagnosis, and the changes after initiation of the different therapies

covid-19 is a disease with an initial viral phase followed, usually at the 7th day, of an inflammatory state (cytokine storm) leading to respiratory distress, icu admission and risk of death. thus, several biological agents, antagonists of the different cytokines (il-6, il-1) have been used for patients with severe disease. however, there are no data about the cytokine changes, at admission and after therapy, and its predictive value, a fundamental knowledge to establish the best therapeutic strategy. the first line of immune defense is the interaction of the virus with innate immunity cell members. the toll like receptors (tlrs) family is a group of pattern recognition receptors that include many different molecules (21-23). these bindings can activate dendritic cells, monocytes, macrophages. there is an important rna and dna connection, activation of tlrs, the production of type i interferons, and the development of some autoimmune diseases. tlr7 and tlr8 specifically recognize simple-chain rna of viruses and are expressed in endosomal membranes. tlr8 is expressed in regulatory cells (treg) and its activation results in inhibition of its regulatory functions. natural killer cells (nk) respond to alterations of class i hla molecules present in infected cells (24-26). an increase in class i hla expression could lead to an increase in nk activation by increasing its ability to produce ifn-gamma. therefore, the reasons for kir binding are often variable between individuals and between populations.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of covid-19 (pcr confirmed) exclusion criteria: * no informed consent * presence of chronic therapy with immunomodulators, corticoids or antineoplastic agents.