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19:07 EST 9th December 2019 | BioPortfolio

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Showing "2019 Tinnitus Clinical Trials Guide Companies Drugs Phases" PubMed Articles 1–25 of 40,000+

From research to practice: clinical phases for drug development.

Clinical trials become very relevant in the development of new drugs when their pharmacokinetics, pharmacodynamics, efficiency, safety and possible adverse effects are being assessed. So new drugs are available for their daily use in patients, a model has been proposed for more than four decades; This model consists in the realization of sequential research studies, which were called clinical phases I, II, III and IV, which begin once the drugs' effects have been verified in cellular and animal models (prec...


New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights.

The enactment of the New Drugs and Clinical Trials Rules, 2019 (hereafter New Rules), on March 19 by the Ministry of Health and Family Welfare (MoHFW), Government of India (1), is the use of power delegated to the political executive by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940. Has this power been used wisely? Whose interests do these rules represent?

Clinical Protocol to Promote Standardization of Basic Tinnitus Services by Audiologists.

Purpose Clinical services for tinnitus are needed by millions of people annually. These services have not been standardized, and patients are vulnerable to receiving services that may appear legitimate but are not based on research evidence. The purpose of this clinical focus article is to promote standardization of tinnitus services by proposing an efficient clinical protocol for audiologists. Method The suggested clinical protocol is based primarily on research conducted at the National Center for Rehabil...


Sensitivity to change and convergent validity of the Tinnitus Functional Index (TFI) and the Tinnitus Questionnaire (TQ): Clinical and research perspectives.

Complete alleviation of tinnitus perception is rarely achieved by current therapeutic interventions. However, adequate therapy may induce a small or large decrement of the tinnitus. The assessment of the therapeutic effect is challenging due to large interindividual variability. Multiple tinnitus questionnaires are available to describe functional effects of tinnitus pre and post-therapeutic intervention, of which the Tinnitus Functional Index (TFI) and Tinnitus Questionnaire (TQ) are two very commonly used...

Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019) : Brighton, UK. 06-09 October 2019.

Clinical practice guidelines for diagnosis and treatment of chronic tinnitus in Japan.

Clinical practice guidelines in Japan for tinnitus were published in May 2019. Effective treatment of tinnitus contributes to quality of life and may improve depression, anxiety, and cognitive function. The highest priority of treatment recommended by this guideline involves educational counseling, including an explanation of the mechanisms of tinnitus. Understanding tinnitus pathology has also been reported to be a therapeutically effective educational counseling strategy. Further, explaining how sound the...

A Tinnitus Symphony in 100 Patients With Meniere's Disease.

Tinnitus is a heterogeneous condition in Meniere's Disease. The type of tinnitus in Meniere's Disease ranged from pure tones to noise-like tinnitus (white, brown and pink noise). Meniere's Disease patients with tonal tinnitus present higher scores in Tinnitus Handicap Inventory compared to Meniere's Disease patients with noise-like tinnitus. There is a positive correlation between Tinnitus Handicap Inventory and Visual Analogue Scale, with a stronger association in patients with bilateral Meniere's Disease....

Tyrosine kinase inhibitors for the treatment of rheumatoid arthritis: phase I to Ⅱ clinical trials.

: Rheumatoid arthritis (RA) is a chronic, refractory disorder caused by autoimmunity in the synovial joints. Disease-modifying anti-rheumatic drugs (DMARDs) and biologicals offer remission in only two-thirds of RA patients within 3 months, hence new therapeutic approaches are necessary. Tyrosine kinase inhibitors (TKIs) are newly developed small molecule drugs which have demonstrated encouraging results in this disease.: The key findings from phase I and II clinical trials that have investigated the use of ...

A scoping review to catalogue tinnitus problems in children.

The reported prevalence of tinnitus in children is similar to that in adults. However, unlike adults, there is relatively little understanding of the tinnitus-related problems children experience. Knowledge of the problems experienced by adults has led to the development of numerous clinical questionnaires used by health professionals in assessment and treatment practices; to date no child-specific questionnaire measure of tinnitus has been developed. To support development of a questionnaire measure of tin...

The Role of the Brainstem in Generating and Modulating Tinnitus.

Purpose The purpose of this work is to present a perspective article summarizing ideas pertaining to the brainstem's role in generating and modulating tinnitus. It is organized in 4 sections: Part 1, the role of the brainstem as a tinnitus generator; Part 2, the role of the brainstem in modulating tinnitus; Part 3, the role of the brainstem in nonauditory comorbid conditions associated with tinnitus; and Part 4, clinical implications. In Part 1, well-established neurophysiological models are discussed provi...

Psychometric assessment of mental health in tinnitus patients, depressive and healthy controls.

Tinnitus describes the perception of a sound without external source and is characterized by high comorbidity, e.g. depression. In many studies, tinnitus patients were compared to healthy controls while a comorbid psychiatric diagnosis was an exclusion criterion. Consequently, patients with severe tinnitus and psychiatric comorbidity were often neglected. In the current study, we tried to fill this gap and compared four groups including two control groups: (1) chronic tinnitus patients with mild tinnitus di...

Huntington's Disease Clinical Trials Corner: June 2019.

In this edition of the Huntington's Disease Clinical Trials Corner we expand on the HD-DBS and on the TRIHEP3 trials, and we list all currently registered and ongoing clinical trials in Huntington's disease.

Do dietary factors significantly influence tinnitus?

Tinnitus is a common and multifactorial condition that requires careful medical assessment and management. Many people with tinnitus believe foods can exacerbate or reduce their perception of the condition, but the research on the relationship between diet and tinnitus is limited.

Tinnitus groups: A model of social support and social connectedness from peer interaction.

Tinnitus is a chronic condition for which there is no medical treatment. Tinnitus groups are a widely available resource for people with tinnitus.

Mechanisms of Noise-Induced Tinnitus: Insights from Cellular Studies.

Tinnitus, sound perception in the absence of physical stimuli, occurs in 15% of the population and is the top-reported disability for soldiers after combat. Noise overexposure is a major factor associated with tinnitus but does not always lead to tinnitus. Furthermore, people with normal audiograms can get tinnitus. In animal models, equivalent cochlear damage occurs in animals with and without behavioral evidence of tinnitus. But cochlear-nerve-recipient neurons in the brainstem demonstrate distinct, synch...

US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.

The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown.

Development and standardization of tinnitus handicap inventory in Nepali.

Tinnitus is a frequent but sparsely understood condition of human ear featuring unusual sensation of acoustic energy. A symptom specific inventory forassessment of tinnitus may aid in understanding the severity of the problem and its impact on individuals' life. Initially, English version of THI was the only existing assessment tool available in measuring the impact of tinnitus. Being a self-report inventory, it is vital that the individuals with tinnitus understand the language foradministering instrument....

Perception Versus Reaction: Comparison of Tinnitus Psychoacoustic Measures and Tinnitus Functional Index Scores.

Purpose Psychoacoustic characteristics of tinnitus include its loudness and pitch. These characteristics are commonly measured and reported; however, it has not been shown that they are associated with the impact, or bothersomeness, of tinnitus. This study addressed this question by determining correlations between measures of tinnitus loudness, tinnitus pitch, and functional effects of tinnitus. Method Tinnitus loudness matches, pitch matches, a numeric rating scale (NRS) of tinnitus loudness, and response...

The Long-term Effectiveness of Tinnitus Multivariate Integrated Sound Therapy (T-MIST) in 148 Tinnitus Patients with Normal Hearing Thresholds: Our Initial Experience.

This preliminary study provides a combined sound therapeutic strategy (called T-MIST) for the management of tinnitus patients with normal hearing thresholds. It takes into account individual tinnitus characteristics and personal choices of sounds to provide an efficient intervention. High-resolution pure tone audiometry was used to measure precise tinnitus pitch and loudness. A Residual Inhibition Test (RIT) was performed using narrow band noise matched to tinnitus frequency at 10 dB above perceived tinnitu...

Glucose-lowering drugs and heart failure: Implications of recent cardiovascular outcome trials in type 2 diabetes.

Heart failure (HF) is common in Type-2 diabetes mellitus (T2DM), and viceversa, leading to a mutual impact on prognosis. Knowledge about this complex interplay has dramatically changed recently, due to development of new glucose-lowering drugs, and to specific FDA and EMA Guidance mandating to perform cardiovascular outcome trials (CVOTs), aimed at establishing cardiovascular safety, for new anti-diabetic treatments before they enter the market. Such CVOTs have demonstrated that the effects of the new antid...

Effects of sound therapy on resting-state functional brain networks in patients with tinnitus: A graph-theoretical-based study.

Tinnitus is considered to be triggered by aberrant neural activity in the brain. Sound therapy is regarded as a reasonable management option for tinnitus treatment and has been applied in the clinical setting for decades.

Analysis of the effect and influencing factors of customized sound on tinnitus.

To explore the effect and influencing factors of customized sound on tinnitus. 303 patients with tinnitus who received customized sound therapy for 6 months were enrolled in this study. Tinnitus handicap inventory (THI) was used to evaluate the treatment effect before treatment, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months after treatment, and the influencing factors of sound treatment effect were analyzed. The THI score decreased at the 1, 2, 3, 4, 5 and 6 months after treatment (0.05). Cus...

Cooper et al. Established search filters may miss studies when identifying randomized controlled trials. J Clin Epidemiol. 2019 Apr 13;112:12-19. doi: 10.1016/j.jclinepi.2019.04.002.

Sleep Disturbances Associated With Tinnitus: Reduce the Maximal Intensity of Tinnitus.

The high prevalence together with the serious impact of sleep disturbances assessed in tinnitus patients urge the need for effective therapy that could improve patients' sleep quality.

Pharmacotherapy in obesity: a systematic review and meta-analysis of randomized controlled trials of anti-obesity drugs.

Obesity poses a significant increase in morbidity and mortality and thus five anti-obesity drugs have been approved currently by US FDA. Several phase 3 trials have shown a significant improvement in cardio-metabolic profile including significant weight reduction with these agents compared to placebo.Areas covered:We systematically searched the database of PubMed, Embase, The Cochrane Library and The ClinicalTrials.gov up to September 30, 2019 and retrieved all the randomized controlled trials (RCTs) that w...


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