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Pediatric Auditory Screening

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601. Broader Implementation of a Successful Dual-Generation Intervention in Partnership With Head Start of Lane County

of the intervention. The investigators hypothesize that families randomly assigned to receive the intervention, compared to families not receiving the intervention, will show improved brain function for attention and self-regulation and improved physiological function for stress regulation in both children and their parents, improvements in child school performance and cognition, and improvements in assessments of parent/family well being. Condition or disease Intervention/treatment Phase School Readiness (...) Behavioral: Creating Connections: Strong Families, Strong Brains Not Applicable Detailed Description: Based on basic research on the neuroplasticity of attention, stress, and family dynamics, the investigators developed a successful dual-generation intervention that targets attention, stress, and self-regulation. The intervention has been shown to improve brain function for attention, cognition, and behavior in preschool children in Head Start (HS) and also improves communication skills and reduces

2016 Clinical Trials

602. Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life

laboratory to complete an 8-min control task every other day for 12 sessions. This control task is identical to the PeCIC except the auditory stop cues are omitted. All other procedures, settings, and schedules are identical to those in the experimental group. The only difference between the groups is that the active control does not practice IC. Behavioral: Active behavioral response training A brief computer-based, multisession training aimed at training behavioral responses to personalized (...) Childhood Experiences (ACEs) questionnaire [Felitti, Anda, Nordenberg, Williamson, Spitz, Edwards, et al., 1998]) IC difficulties such as disinhibited alcohol use, tobacco use, or food intake during adulthood. IC difficulties will be self-reported based on questions from the self-control questionnaire (Tangney, Baumeister, & Boone, 2004) modified to be specific to alcohol, tobacco, and energy-dense food intake (e.g., "I am self-indulgent with unhealthy food at times", "I refuse alcohol when offered

2016 Clinical Trials

603. Deferasirox in Treating Patients With Very Low, Low, or Intermediate-Risk Red Blood Cell Transfusion Dependent Anemia or Myelodysplastic Syndrome

as: hemoglobin =< 10.0 g/dL Bilirubin =< 1.5 times upper limit of normal (ULN) Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) =< 3.5 times ULN Serum creatinine =< 1.5 x ULN Estimated glomerular filtration rate (GFR) > 40 mL/min Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of deferasirox Women of child-bearing potential, defined as all women physiologically capable (...) , ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment Male sterilization (at least 6 months prior to screening); for female subjects on the study

2016 Clinical Trials

604. Krabbe Disease Global Patient Registry

literature is limited regarding the clinical signs and symptoms of the later-onset forms of Krabbe disease, as well as their age of onset, and survival of these individuals. Early-infantile Krabbe disease has a uniformly fatal outcome if untreated, and later-onset forms remain at-risk for developing symptoms. The only available treatment, pooled cord-blood transplantation, has a 10-20% mortality rate. The vast majority of children who screen positively for Krabbe disease during newborn screening have (...) on the South Campus, and/or the Longitudinal Pediatric Data Resource, a tool provided by the Newborn Screening Translational Research Network. Study Design Go to Layout table for study information Study Type : Observational [Patient Registry] Estimated Enrollment : 60 participants Observational Model: Cohort Time Perspective: Prospective Target Follow-Up Duration: 5 Years Official Title: The Hunter James Kelly Research Institute's Clinical Database of Patients With Krabbe Disease, A World-Wide Registry

2016 Clinical Trials

605. Light-deprivation Utilized to Mitigate Amblyopia

Institute (NEI) Information provided by (Responsible Party): Ben Backus, State University of New York College of Optometry Study Details Study Description Go to Brief Summary: Amblyopia is an impairment in spatial vision caused by asymmetry in the quality of visual input across the two eyes during childhood. It is difficult to treat in adulthood because the visual system becomes less "plastic" (able to learn) with age. The purpose of this study is to determine whether five to ten days of visual (...) , amblyopes will be form deprivation amblyopes, especially form deprivation due to anisometropia, with moderate (20/30 to 20/80) or severe (20/100 to 20/400) acuity in the affected eye. Screening will include an extensive application, telephone interview of two personal references, comprehensive visual examination, and in-person interview. Participants will be fitted with new ophthalmics if indicated and followed for several weeks to allow their amblyopia to stabilize. Their visual function

2016 Clinical Trials

606. Perception of Stressful Social Stimuli After Trauma Exposure.

Hospital, Bonn Study Details Study Description Go to Brief Summary: Post-traumatic stress disorder is associated with altered processing of sensory stimuli. The clinical phenotype PTSD has predominantly been described for the visual and auditory sensory modalities. However, PTSD symptoms such as intrusive memories are often evoked by olfactory and tactile cues in the environment. Moreover, little is known about whether aberrant responses to social olfactory and tactile stimuli are also present (...) in a subclinical population.The purpose of this study is to compare trauma-exposed subjects (e.g. childhood maltreatment) with non-exposed controls in the processing of olfactory and tactile stimuli. This sensory characterizations hold potential to identify potential biomarkers for the course of trauma-related disorders and to inform trauma therapies focusing on sensory integration. Condition or disease Intervention/treatment Post-traumatic Stress Disorder Behavioral: Processing of social olfactory and tactile

2016 Clinical Trials

607. Piloting Treatment With Intranasal Oxytocin in Phelan-McDermid Syndrome

to measure attention. three computer screens are set up side by side. A stimulus initially appears on the central screen, and once the participant orients to that stimulus, another stimulus will appear on one of the lateral screens. In the "gap" condition, the central stimulus will disappear before the peripheral stimulus appears. In the "overlap" condition, the central stimulus will remain on the screen while the peripheral stimulus appears. In both conditions, reaction times of the participant's eye (...) at week 12 as compared to baseline, measuring sensory sensitivity and sensory seeking behavior. Macarthur-Bates Communicative Development Inventory [ Time Frame: Baseline and Week 12 ] Macarthur-Bates Communicative Development Inventory at week 12 as compared to baseline, measuring language. Electrophysiology Recording [ Time Frame: Baseline and Week 12 ] Change at 12 weeks as compared to baseline using electroencephalographic recordings to measure Visual Evoked and Auditory Event Related Potentials

2016 Clinical Trials

608. Metabolic Processes in Adults and Adolescents With Autism Spectrum Disorder

of numbers in the same order (Digit Forward) and in reverse order (Digit Backward). Measures auditory attention and verbal working memory. Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA) [ Time Frame: 1 day ] assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning. Group differences in attention and executive functions as measured (...) healthy young adults. The study involves 1 screening visit of approximately 2 hours and 1 study day of 5 hours The objective is to explore changes in amino acids (e.g. TRP pathway) in ASD and evaluate the function of TRP in neuropsychological functions by using the technique of stable isotope and our newly developed 'single pulse method' with multiple amino acid and keto-acid isotopes. The aim of this study is to determine the underlying mechanism by which the metabolism of amino acids such as TRP

2016 Clinical Trials

609. HIRREM Developmental Study

HIRREM This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. Device: HIRREM HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neuro-technology to facilitate recipient-unique relaxation, auto-calibration, and self-optimization of cortical neural oscillations by reflecting auditory tones (...) , and 4-8 weeks after completion of the intervention. ] The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression38. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Secondary outcomes will be analyzed for change from baseline to 1-2 weeks after completion of the intervention, and changes from baseline to 4-8 weeks after completion of the intervention. EQ-5D [ Time Frame: Data used for analysis of secondary

2016 Clinical Trials

610. Multichannel Vestibular Implant Early Feasibility Study

Intervention/treatment Experimental: vestibular implant From up to 60 enrolled and screened subjects, up to 15 subjects will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System Device: Labyrinth Devices MVI™ Multichannel Vestibular Implant Outcome Measures Go to Primary Outcome Measures : Identified adverse events to assess the safety of the Labyrinth Devices Multichannel Vestibular Implant (MVI). [ Time Frame: through study completion (...) under either the unaided condition or, if 0.5/1/2/4 kHz PTA>50 dB, the best-aided condition Caloric responses consistent with severe or profound bilateral loss of labyrinthine function (total caloric response to warm and cool caloric stimuli <10°/sec in each ear; lack of a reversal of response on ice-water caloric stimulation when subject reorients from supine to prone) Prior MRI imaging of the brain, internal auditory canals and cerebellopontine (CP) angle showing a patent labyrinth, present

2016 Clinical Trials

611. Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients

(-0.50 SD or below) on either the Wechsler Adult Intelligence Scale-IV (WAIS-IV) -Coding subtest, or the Rey Auditory Verbal Learning Test (RAVLT) total learning score on trials 1 to 5 or immediate recall, at screening visit. A WAIS-IV vocabulary scaled score >5 (equivalent to estimated IQ 80 or greater). A sufficient level of the English language. Females who are postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) or are surgically sterile. Females (...) Update Posted : June 21, 2018 See Sponsor: Nazlin Walji Information provided by (Responsible Party): Nazlin Walji, University of British Columbia Study Details Study Description Go to Brief Summary: This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled

2016 Clinical Trials

612. Simultaneous Recordings of Cervical and Ocular Vestibular-evoked Myogenic Potentials

information Ages Eligible for Study: 15 Years to 85 Years (Child, Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Sampling Method: Non-Probability Sample Study Population About thirty healthy volunteers without a previous history of vertigo or neuro-otologic diseases will be enrolled in this study. The subjects were also screened with a full history on vestibular disorders, with pure tone audiogram, and head-impulse tests to exclude the possibility of previous vestibular (...) . The subjects will be also screened with a full history on vestibular disorders, with pure tone audiogram, and head-impulse tests to exclude the possibility of previous vestibular disorders or migraine which may cause abnormal VEMPs. Other: Vestibular evoked myogenic potentials (VEMPs) The c- and oVEMPs will be assessed in three different sessions including conventional sequential recordings and two different simultaneous recording methods, i.e., unilateral simultaneous recording of cVEMPs and oVEMPs during

2016 Clinical Trials

613. Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions

to the doctor recommendation. During capsule procedure the subjects will be contacted by phone several times daily by the site clinical study team (or by dedicated external trained medical personnel), to assure the subjects well-being and to monitor for any change or discomfort and for procedure progress. Subjects may be also monitored by the technical team (either at home or at the clinic), who may need to examine the system or inquire the subjects about the system visual/auditory indicators. The subjects (...) will be provided with a dedicated capsule collection kit, to assist the subjects in collecting the capsule. Subjects will be instructed to retrieve the capsule upon excretion. Capsule procedure is completed upon capsule excretion or system vibro/auditory indication of 'End of Procedure'. Patients will be instructed to return the C-Scan Capsule and C-Scan Track to the clinic for analysis. All subjects will be scheduled for optical colonoscopy to be performed within one month following capsule procedure. C-Scan

2016 Clinical Trials

614. RAD001 and Neurocognition in PTEN Hamartoma Tumor Syndrome

Collaborators: National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) Office of Rare Diseases (ORD) National Center for Advancing Translational Science (NCATS) Novartis Pharmaceuticals PTEN Research Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Information provided by (Responsible Party): Mustafa Sahin, Boston Children’s Hospital Study Details Study Description Go to Brief Summary: Phosphatase and TENsin homolog (PTEN (...) for at least 2 months prior to the screening visit; Negative serum pregnancy test for females at screening and no plans to become pregnant or conceive a child while participating in the study. The effects of mTOR inhibitors on the developing fetus at the doses used in this study are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Estrogen-containing oral contraceptives are not recommended

2016 Clinical Trials

615. Study to Evaluate the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Participants With Major Depressive Disorder (MDD)

: by the speech recognition engine (SRE) and by an on-site test supervisor who will record the responses directly on the Revere.D application from a touch screen on the iPad. Performance Score on a Cognitive Test Battery Evaluated by Visuospatial Block Recall Test (VBRT) [ Time Frame: Up to Test Day 4 (Day 43 to 64) ] The VBRT is based on a visuospatial learning test that requires participants to recall the location of colored tiles within an onscreen grid. Performance on visuospatial recall tasks has been (...) shown to be lowered in anxious, depressed, or older healthy participants, as well as in participants with mild traumatic brain injury, schizophrenia, and acquired immune deficiency syndrome (AIDS) dementia complex. The participant is shown a sequence of on screen grids on which an increasingly complex pattern of colored tiles is depicted. Each pattern displays for only a brief period (0.5 seconds), after which participants are asked to recall the pattern. Recall accuracy (the number of correctly

2016 Clinical Trials

616. Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes

auditory changes from baseline to 4 weeks. Ophthalmologic changes or development of Uveitis of Grade 2 or higher as related to study drug, graded according to NCI CTCAE Version 4.0 [ Time Frame: Baseline and 4 weeks ] Potential visual changes from baseline to 4 weeks. CT scans or physical examination from approximately 18 patients will be used to evaluate for a clinical objective response using RECIST Guideline Version 1.1 [ Time Frame: Baseline and 4 weeks ] CT scan or physical examination (...) . Patients must have a performance status (PS) of 0 or 1 ECOG PS scale. Patients must have the ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time. Patients melanoma must be positive for both tyrosinase and HLA-A2 pathologic review from FNA, core or excisional biopsy of lesion. Cardiac ejection fraction greater than 50 percent as determined by screening echocardiogram

2016 Clinical Trials

617. Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception

severity of the tinnitus and the effect on everyday activities and quality of life. A visual analog scale (a scale from 0-10) is used as a general subjective measurement of tinnitus severity. In the first part of this study, we will measure each of these parameters over a series of sessions to establish a baseline variability for each individual. The second part will look at the influence of context-specific visual information on auditory perception. This involves watching silent videos of a person (...) of a person speaking or a still face with an expanding circle over the mouth presented on a computer or tablet screen. Outcome Measures Go to Primary Outcome Measures : Change in Minimal Masking Level [ Time Frame: Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm. ] A narrowband noise (from 2-12 kHz) is presented to the tinnitus ear and the minimum sound level (in decibel sound pressure level, decibel SPL) is determined that completely masks the tinnitus

2016 Clinical Trials

618. A Salivary miRNA Diagnostic Test for Autism

- Upstate Medical University Collaborator: National Institute of Mental Health (NIMH) Information provided by (Responsible Party): Frank Middleton, PhD, State University of New York - Upstate Medical University Study Details Study Description Go to Brief Summary: The goal of this study is to identify miRNAs that are at increased or decreased levels in the saliva of children with autism spectrum disorder (ASD) or developmental delay and would be useful biomarkers for the screening of toddlers and young (...) with ASD. Studies on miRNAs have shown that they can be extruded from neurons as extracellular signaling molecules and this knowledge provides a new approach for examining the genetic regulation of the central nervous system. In this study we are measuring the expression of extracellular miRNA in children with ASD. Levels of miRNA from saliva will be compared to those of normally developing controls. The goal of this research will be to provide possible biomarkers for diagnostic screening of ASD

2016 Clinical Trials

619. TMS for Symptom Reduction in Schizophrenia

. Elliot Hong, University of Maryland Study Details Study Description Go to Brief Summary: Neuroimaging studies suggest that aberrant activities at specific brain regions such as sensory areas and language-related areas are related to psychosis symptoms including auditory and visual hallucination, delusion, and thought disorders. Transcranial magnetic stimulation (TMS) provides a non-invasive means for altering brain electrical neural activity. TMS has been approved by FDA for treatment of depression (...) . Other applications have not been approved but it has been used in a wide range of clinical research especially in neurology and psychiatry. Among psychotic symptoms, there are preliminary significant improvement in treatments of auditory hallucination using TMS with small samples, but those treatments are not robust in larger samples. The high inter-subject variability limits the efficacy of TMS treatment in schizophrenia patients. We aim to develop a TMS treatment method with a fMRI-defined

2016 Clinical Trials

620. Cognitive Training in Parkinson Study

test of the Wechsler adult intelligence test (WAIS)-III. Specific cognitive functioning: episodic memory (1) [ Time Frame: T0, T1, T2, T3, T4 ] Episodic memory function, measured by the Dutch version of the Auditory verbal learning test (RAVLT). Specific cognitive functioning: episodic memory (2) [ Time Frame: T0, T1, T2, T3, T4 ] Episodic memory function, measured by the Location learning task. Specific cognitive functioning: language (1) [ Time Frame: T0, T1, T2, T3, T4 ] Language function (...) the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: Child, Adult, Older Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Subjective cognitive complaints, measured by the Parkinson's Disease Cognitive Functional Rating Scale score > 3 (PD-CFRS). A score above 3 indicates significant cognitive complaints, that are milder than complaints associated

2016 Clinical Trials

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