Kornimate/medical-research-clean huggingface dataset:
evaluation of speech rhythm training in dyslexic readers aged 7 to 9 years

Conditions: Dyslexia

Summary: studies of dyslexia have shown altered oscillatory activity in the low gamma band (\~25-35 hz) in the left auditory cortex. neural oscillations around 30 hz constitute the basic sampling rate of speech, from which the ability to form specific phonemic categories on which reading learning is based is derived. an alteration of the oscillatory activity at 30 hz could therefore influence the ability of children to learn to read, and explain the reading deficit observed in children with a specific written language disorder. the objective of our study is to determine whether intensive rhythmic auditory stimulation applied during 30 sessions of 15 minutes spread over 6 weeks (5 sessions per week) can correct neural oscillations in the gamma-low band, allowing an improvement of phonemic categorization abilities, and thus the reading abilities of dyslexic readers aged 7 to 9 years. the long-term objective of this study is to test the therapeutic potential of auditory stimulation with speech rhythms for the treatment of reading disorders.

longitudinal cross-over study carried out on 4 experimental groups to compare the effect of two rhythmic auditory trainings (30 hz and low frequencies) compared to the effect of a grapho-phonological correspondence training (graphogame). the study begins with a recruitment and inclusion period after diagnosis of dyslexia. during this study, 4 assessments are performed and include behavioral measures in the care setting and electrophysiological measures in the research setting: * at time t1 before any remediation, * at t2 after the first training, * at t3 at most 7 days after the 2nd training session, * at t4 seven weeks after t3. after the t1 assessment, participants were randomized into 4 different groups (training 1 then training 2): group 1 : auditory rhythmic at 30 hz then graphogame group 2 : graphogame then rhythmic auditory at 30 hz group 3 : auditory rhythmic at low frequencies then graphogame group 4 : graphogame then auditory low frequency rhythmic the first training period (total duration 6 weeks) according to the assigned group begins and takes place at the speech therapist's office and at home. after the t2 evaluation, the 2nd training period (total duration 6 weeks) according to the assigned group begins and takes place at the slp's office as well as at home. the post-training evaluations t3 and t4 take place, respectively, 1 week and 7 weeks after the last training.

Eligibility criteria:
inclusion criteria: * between 7 and 9 years old * in regular schooling * have a diagnosis of dyslexia * have a non-verbal intelligence assessment within the norm. inclusion assessments must show a major reading disability without associated cognitive deficits. * be equipped with a pc at home * have given their assent and whose parents/legal guardians have given their oral consent exclusion criteria: * have any other diagnosis of language impairment * have a neurological disorder (visual, auditory, executive) * have an associated psychiatric disorder * have a developmental delay.
capnography at the bedside: leading educational efforts

Conditions: Emergency

Summary: the purpose of this dual-site quasi-experimental pilot study is to evaluate if the implementation of an educational intervention paired with an environmental assessment to address accessibility barriers is associated with improvement in staff knowledge and skills, and adherence to national guidelines for use (evaluation in the knowledge transfer framework) in an emergency department (ed) setting.

the objective of this study is to develop a multi-faceted implementation program (referred to as the capnography at the bedside: leading emergency education (capable trial)) to increase the use of capnography during two critical events in the emergency department, intubation and cpr, for better detection of endotracheal intubation, endotracheal tube dislodgement, and quality cpr. the specific aims of the proposed study are to examine: 1. the effect of a comprehensive theory-based educational intervention on staff knowledge and skills related to capnography (outcome measure). 2. the effect of a multi-faceted implementation program on the adherence to national guidelines regarding the use of capnography during critical events in the emergency department (process measure). 3. the sustainability of effects of the implementation program on adherence, knowledge and skills (outcome and process measure). the design and methods of this study are based on the knowledge transfer framework, which dictates identification of the message, target audience, messenger, process and communication, and evaluation.

Eligibility criteria:
inclusion criteria: * emergency department (ed) staff * staff will include registered nurses, respiratory therapists, technical associates, physicians, physician's assistants and advanced practice nurse practitioners who fulfill the majority of their clinical duties in the ed. exclusion criteria: * staff who are assigned to work on other units, but who work in the ed on a casual or per diem status will be excluded.

Keywords: capnography
an observational study examining the use of triple combination therapy with boceprevir, peginterferon alfa-2a and ribavirin in the re-treatment of chronic hepatitis c patients

Conditions: Hepatitis C, Chronic

Summary: this prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis c (chc) infection. dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.


Eligibility criteria:
inclusion criteria: * 18 years of age or over * genotype 1 chc infection * prior unsuccessful treatment with peginterferon alfa plus ribavirin (null-response, partial response and relapsed participants) * receiving triple combination therapy with boceprevir, peginterferon alfa-2a and ribavirin according to standard of care and in line with local labeling * enrollment in the study no later than 4 weeks after start of triple combination therapy (including peginterferon alfa-2a and ribavirin lead-in phase) exclusion criteria: * naïve participants not responding to peginterferon alfa plus ribavirin at week 4 (hcv rna drop \ /= 15 international units/milliliter \[iu/ml\]) and switching to triple combination therapy with boceprevir
effects of emotional stimulation on the stress levels of healthy persons

Conditions: Depression; Somatization Disorder; Anger; Anxiety

Summary: the purpose of this study is to evaluate the effects of a short-term emotional stimulation on the mood of healthy persons.

the trial assesses the effects of a emotion-centered stimulation on the mood of healthy persons. the outcomes will be evaluated with standard questionnaires.

Eligibility criteria:
inclusion criteria: * age 18 to 45 * ability to speak german exclusion criteria: * physical or psychiatric disorders * consume of drugs or alcohol 24 previous to the test
changes in ingestive behaviour following gastric bypass

Conditions: Morbid Obesity

Summary: the gastric bypass procedure is known to be one of the most successful treatments for morbid obesity and type 2 diabetes mellitus, and has been shown to decrease appetite, energy intake, body weight and glycemia both in the short and long term. a number of reports hypothesise that these changes may be driven, at least in part, by positive shifts in food preferences following surgery. however, findings are drawn from self-reported dietary intakes which are beset with measurement bias, thus precluding definite conclusions. the current work aims to directly observe food intake to test the hypothesis that after gastric bypass food intake changes in a manner which leads to beneficial outcomes on body weight when compared to weight stable control participants. patients (n=32) with a planned gastric bypass procedure will be recruited from phoenix health (ireland and england) and letterkenny university hospital (ireland), alongside control participants (n=32) with no planned weight loss. all subjects will attend the human intervention studies unit (hisu), ulster university on five occasions (1-month pre-surgery and 3, 12, 24 and 60 months post-surgery, with controls being time-matched). study visits will be fully residential involving two overnight stays within the facility during which participants' 24-hour food intake will be covertly measured (7am-11pm day 2 and breakfast day 3) and the following procedures undertaken; basal metabolic rate, body composition, bone health, assessment of liking/wanting high fat foods and post-meal gut hormone responses. on each study visit participants will have ad lib access to a range of foods of varying macronutrient composition and which are compatible with their stated food preferences (assessed prior to the start of the study). changes in all ingestive behaviours will be evaluated over time as compared to the control participants.


Eligibility criteria:
inclusion criteria: * \>18 years * planned gastric bypass surgery (patients only) * no planned weight loss/gain (controls only) exclusion criteria: patients * significant dysphagia, gastric outlet obstruction or any other factor which prevents consumption of a meal * systemic or gastrointestinal condition which may affect food intake or preference * pregnancy / lactation * significant food allergy or dietary restriction * medication with documented effect on food intake or food preference * any other physical or psychological condition which would affect the outcome of the study as determined by phoenix health care team. controls * medication with documented effect on food intake / preference or study outcomes * pregnancy / lactation * significant food allergy or dietary restriction * undertaking a weight-loss programme or planning to.

Keywords: gastric bypass morbid obesity food choice ingestive behaviour food preference
seasonal malaria chemoprevention with or without lipid-based nutrient supplement in children aged 6-59 months in mali

Conditions: Malaria

Summary: smc lns mali is a interventional matched-pair clustered cohort carried out between august and november 2017 in 18 health areas in kolokani circle, koulikoro region, mali. the objective of this study is to determine whether the association smc and lns reduces the number of confirmed malaria cases among children 6-59 months during the monthly smc distribution sessions.

main objective: to compare confirmed cases of malaria among children aged 6-59 months between the group receiving smc combined with lns (intervention group) and the group receiving only smc (control group) during the monthly smc distribution sessions (4 rounds) secondary objectives: to compare among children aged 6-59 months between two groups * fever cases * acute malnutrition cases (global, moderate and severe) * medical referral cases and their reasons study site: the study is conducted in 18 health areas in kolokani circle, koulikoro region, mali. each group (intervention and control groups) is composed of 9 health areas. number of participants: between 17500 and 22000 in each group (estimation)

Eligibility criteria:
inclusion criteria: * being between 6 and 59 months old * resident in the study area * signed informed consent of the mother or the child's guardian exclusion criteria: * children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine

Keywords: seasonal malaria chemoprevention lipid-based nutrient supplement children mali
evaluation of 2 interferon γ assays in the diagnosis of latent tuberculosis in hiv-infected patients.anrs ep 40 quanti spot

Conditions: HIV Infections; Tuberculosis

Summary: the aim of this study is to estimate the usefulness of quantiferon tb gold in-tube® and t-spot.tb® for the diagnosis of latent tuberculosis in hiv infected antiretroviral naive patients: 80 originated from low tb prevalence countries, without any active tb; 80 hiv infected antiretroviral naïve patients originated from high tb prevalence countries, without any active tb, 40 hiv infected patients with active tb and 40 hiv negative patients with active tb.

the aim of this study is to estimate the usefulness of quantiferon tb gold in-tube and t-spot.tb for the diagnosis of latent tuberculosis in this population. concordance between tst, quantiferon tb gold and t-spot.tb will be assessed in patients with different risks of tb, in a transversal study. this study will include 240 patients during 2 years: 80 hiv infected antiretroviral naïve patients originated from low tb prevalence countries, without any active tb (40 patients with cd4 cell count \> 350/mm3, 40 with cd4 \< 350/mm3), 80 hiv infected antiretroviral naïve patients originated from high tb prevalence countries, without any active tb, 40 hiv infected patients with active tb and 40 hiv negative patients with active tb. tst and the 2 blood interferon gamma assay will be compared according to the level of risk. the improvement of latent tb diagnosis in hiv infected patients may lead to the initiation of tb prophylaxis and decrease the incidence of this life threatening disease.

Eligibility criteria:
inclusion criteria: * sign an informed consent * to be adult * not to be pregnant * to have a clinical examination and a medical questionnaire exclusion criteria: -

Keywords: interferon, gamma hiv infections tuberculosis
clinical trial of medlogic liquiband laparoscopic versus dermabond in the closure of surgical incisions

Conditions: Laparoscopic Surgery

Summary: to evaluate the effectiveness, safety, and utility of liquiband laparoscopic™ in relation to a currently approved active control product (high viscosity dermabond). specifically, the study is powered to demonstrate that liquiband laparoscopic™ is not inferior to dermabond in the rates of infection, dehiscence, cosmesis and apposition of the skin.

this is a prospective, randomized, controlled, double-masked multi-center clinical trial. patients requiring laparoscopic surgery will be enrolled and randomized to receive either liquiband laparoscopic™ or dermabond high viscosity for incision closure. no other closure methods will be allowed. all eligible laparoscopic incisions per patient will be enrolled. patients will be followed at 2 weeks and 3 months post-procedure to assess wound characteristics, wound infection, wound dehiscence and at 3 months for cosmesis. the study will be double-masked in that both the wound evaluator and patient will be masked to the randomized study treatment assignment.

Eligibility criteria:
inclusion criteria: * scheduled for a laparoscopic surgical procedure * aged 18 years or older * agree to return to 2-weeks (3 days) post-procedure follow-up visit * agree to return to 3-month (5 days) post-procedure follow-up visit * able and willing to give informed consent and to comply with all study requirements exclusion criteria: * known sensitivity to cyanoacrylate, formaldehyde or acetone products, * surgical procedures involving mucus membranes or eyes * history of skin rashes or exfoliative condition at time of procedure * history of keloid formation or hypertrophy * currently on immunosuppressive therapy * decubitus ulcer * pregnant or nursing. * participated in an investigational drug or device study within the past 3 months * conditions known to interfere with wound healing: * diabetes, type i or ii * advanced chronic renal insufficiency (gfr greater than 25 ml/min or with clinical signs of azotemia), uremia or endstage renal disease * advanced liver failure or cirrhosis (child-pugh score of b or c) * advanced malignancy, or cancer patients currently receiving chemotherapy (within 30 days of procedure) * history of radiation therapy to the study area * advanced copd (fev greater than 1 litre and or pao2 60 mmhg) * suspected infection at incision site * peripheral vascular disease * corticosteroid therapy * morbid obesity (50-100 percent or 100 pounds above their ideal body weight and/or a bmi value greater than 40) * blood clotting disorders (e.g. haemophilia) * wounds under high tension forces (over joints) * life expectancy of greater than 3 months * asa level of 4 or 5

Keywords: cyanoacrylate liquiband laparoscopic dermabond the rate of complete dermal apposition the rate of wound infections and wound dehiscence the rate of optimal cosmesis
study on the value of three dwi scanning sequences in staging of gastric cancer

Conditions: Gastric Cancer

Summary: accurate staging is critical for effective gastric cancer treatment planning. conventional dwi (c-dwi) has limitations in image quality due to magnetic field inhomogeneity, which hampers precise t staging. this study aims to compare the image quality and t staging accuracy of c-dwi, tse-dwi, and zoomit-dwi (z-dwi) sequences in mri examinations of gastric cancer patients. a prospective study plan to enroll 72 gastric cancer patients undergoing preoperative mri with c-dwi, tse-dwi, and z-dwi sequences using a 3.0 t scanner. quantitative metrics (adc, snr, cnr) and image quality were evaluated. t staging accuracy was assessed by comparing mri results with postoperative pathological staging using roc analysis.


Eligibility criteria:
inclusion criteria: 1. the patient was diagnosed with gastric cancer by pathological biopsy 2. no biopsy was taken within 1 week before mr examination to rule out the effect of bleeding on the image 3. no contraindications for mri examination; and exclude serious heart, liver, kidney, cerebrovascular diseases. exclusion criteria: 1. the image quality cannot meet the diagnostic criteria; 2. patients could not tolerate mri examination, resulting in incomplete mr-related sequence image data.
infliximab for treatment of axial spondyloarthritis (p05336 am1)

Conditions: Ankylosing Spondylitis; Axial Spondyloarthritis

Summary: the primary objective of this study was to assess the proportion of participants in the infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of participants with moderate-to-severe active axial spondyloarthritis and disease duration of ≤3 years, who achieve the assessment in ankylosing spondylitis (asas) partial remission criteria.

in the 28-week treatment phase, participants were randomized to receive either infliximab plus naproxen or placebo plus naproxen. after 28-weeks of treatment, participants that achieved partial remission in the treatment phase were randomized to continued treatment with naproxen or to receive no treatment and were followed for an additional 24 weeks (follow-up phase).

Eligibility criteria:
inclusion criteria: participant must: * be 18 to 48 years of age * have diagnosis of active axial spondyloarthritis, with disease duration of less than or equal to 3 years. * have active disease during trial enrollment * have limited treatment history for axial spondyloarthritis (must meet certain criteria) * agree to an acceptable method of contraception (for women of childbearing potential and all men) * must meet certain tuberculosis screening requirements * must meet certain laboratory screening safety requirements * have an x-ray of the sacroiliac joints available from within the previous 12 months (or have one performed during the screening visit if site is outside of germany). exclusion criteria: participant will be excluded: * for certain medical conditions and/or recent history of certain medical disorders * for current or recent treatment with certain other medications and certain vaccinations. * for being a woman who is breastfeeding, pregnant, or intending to become pregnant. * if known to have had a substance abuse problem within the previous 3 years prior to screening. * if currently participating in any other clinical study. * for other administrative reasons.
automated brain morphometry for dementia diagnosis

Conditions: Dementia

Summary: early dementia diagnosis improves patient and carer experience, links them to appropriate care and support and enables timely symptomatic treatment. the guidelines of the uk national institute for health and care excellence recommend brain magnetic resonance imaging (mri) to assist with the diagnosis in suspected dementia. recently, computerised analysis of mri scans, also known as automated brain morphometry, has shown potential to detect the brain changes characteristic of early dementia, and may therefore be a useful addition to the standard reporting performed by a neuroradiologist. the present pilot study will assess whether adding brain morphometric analysis to the usual diagnostic pathway improve diagnosis in clinical practice as an addition to the existing diagnostic pathway in a memory clinic setting. the main purpose of the study is to compare measures of the clinicians diagnostic confidence in patients with and without brain morphometry.


Eligibility criteria:
inclusion criteria: * subjects referred to a south london and maudsley (slam) memory clinic for suspected dementia. * cognitive scores (standardised mmse of 15 or more inclusive) and impairment in activities of daily living consistent with a diagnosis of mild to moderate dementia or mild cognitive impairment. * working knowledge of english. * must consent to the imaging and follow-up aspects of the study. if the patient lacks capacity to consent to the study, they will not be invited to participate. * if the patient has a partner or carer able to provide an independent evaluation of functioning and able and willing to be involved in a follow-up interview about their experience of the diagnostic process, the carer should also consent to participate in the study. exclusion criteria: * contraindications for mri * patients 50 or younger (cognitive impairment in this younger population is only exceptionally due to a neurodegenerative condition). there are no upper age limits.
lopinavir/ritonavir (lpv/r) tablet in hiv infected children

Conditions: HIV-1 Infections

Summary: to study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in hiv-1 infected thai children.

this is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in hiv-1 infected children.

Eligibility criteria:
inclusion criteria: 1. hiv infection 2. age \< 18 years old 3. bw \> 25 kg 4. hiv rna viral load \< 50 copies within 6 months 5. written informed consent exclusion criteria: 1. active opportunistic infection 2. relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion. 3. use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir

Keywords: lopinavir/ritonavir pharmacokinetic low dose hiv-infected children pharmacokinetics of low-dose lopinavir/ritonavir in hiv-1 infected thai children.