A5051189755- Respiratory and Cough-Related Research
- Voice and Speech Disorders
- Asthma and respiratory diseases
- Substance Abuse Treatment and Outcomes
- Psoriasis: Treatment and Pathogenesis
- Pediatric health and respiratory diseases
- Opioid Use Disorder Treatment
- Health Policy Implementation Science
- Gastroesophageal reflux and treatments
- Ethics in Clinical Research
- Prenatal Substance Exposure Effects
- Dermatology and Skin Diseases
- Autoimmune Bullous Skin Diseases
- Mental Health Treatment and Access
- Pharmaceutical studies and practices
- Pain Management and Opioid Use
- Child and Adolescent Psychosocial and Emotional Development
- Meta-analysis and systematic reviews
- Neurofibromatosis and Schwannoma Cases
- Statistical Methods in Clinical Trials
- Sexual Differentiation and Disorders
- Cholesterol and Lipid Metabolism
- Community Health and Development
- Digital Mental Health Interventions
- Blood Pressure and Hypertension Studies
Merck & Co., Inc., Rahway, NJ, USA (United States)
2016-2025
National Institute on Drug Abuse
2012-2024
National Institutes of Health
2012-2024
Museum of Heilongjiang Province
2021
Istituto Giannina Gaslini
2002-2005
University of Genoa
2003
Flinders Medical Centre
1984
University of South Australia
1984
Flinders University
1984
Patients with chronic cough experience considerable burden. The severity visual analog scale (VAS) records patients' assessment of on a 100-mm linear ranging from "no cough" (0 mm) to "worst (100 mm). Although scales are widely used in clinical practice and research, their use patients refractory or unexplained has not been formally validated.This analysis includes data phase 2b randomized controlled trial the P2X3-receptor antagonist gefapixant for treatment (NCT02612610). Cough VAS scores...
The Leicester Cough Questionnaire (LCQ), a cough-specific quality-of-life measure, evaluates the impact of cough across physical, psychological, and social domains in patients with chronic (CC). This study assessed psychometric properties LCQ.Data from phase IIb, randomized controlled trial P2X3-receptor antagonist gefapixant were analyzed (NCT02612610). Subjective [Cough Severity Diary, severity visual analogue scale, patient global impression change (PGIC)] objective (awake 24-h frequency)...
Hispanic individuals are underrepresented in clinical and research populations often excluded from trials the United States. Hence, there few data on effectiveness of most empirically validated therapies for substance users. The authors conducted a multisite randomized trial comparing 3 individual sessions motivational enhancement therapy with that counseling as usual treatment retention frequency use; all assessment were Spanish among 405 seeking any type current use. Treatment exposure was...
Short-term interleukin-23p19 inhibition by tildrakizumab improves plaque psoriasis and appears to be well tolerated.Safety tolerability were assessed for up 64 weeks of therapy using pooled data from three randomized controlled trials moderate-to-severe psoriasis.Data pools the placebo-controlled (up 16 weeks) full trial periods analysed (n = 2081).In period, frequencies treatment-emergent adverse events (TEAEs; range 47·9-54·0%), serious TEAEs (range 1·4-2·3%), discontinuations due AEs...
<h3>Importance</h3> Guidelines recommend that adult patients receive screening for alcohol and drug use during primary care visits, but the adoption of in routine practice remains low. Clinics frequently struggle to choose a approach is best suited their resources, workflows, patient populations. <h3>Objective</h3> To evaluate how implement electronic health record (EHR)–integrated substance by comparing commonly used methods examining association with implementation outcomes. <h3>Design,...
Abstract Purpose We evaluated gefapixant, a P2X3 receptor antagonist, in participants with recent-onset (≤ 12 months) refractory chronic cough (RCC) or unexplained (UCC). Methods Participants (≥ 18 years of age; ≥ 40 mm on 100-mm severity visual analog scale [VAS] at screening and randomization) for < months were enrolled this phase 3b, double-blind, placebo-controlled, parallel group, multicenter study (NCT04193202). randomized 1:1 to gefapixant 45 mg BID placebo weeks 2-week follow-up....
Background: Community Based and Tribally Participatory Research (CBPR/TPR) are approaches that can be successful for developing ethical effective research partnerships between academic institutions Tribes Native organizations. Objectives: The NIDA Clinical Trials Network funded a multi-site, exploratory study using CBPR/TPR to begin better understand substance abuse issues of concern some organizations as well strengths resources exist in these communities address concerns. Attention was...
We present study designs, dose selection and preliminary patient characteristics from two phase 3 clinical trials of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough (RCC) or unexplained (UCC).COUGH-1 (NCT03449134) COUGH-2 (NCT03449147) are randomised, placebo-controlled, double-blind, parallel-group subjects with RCC UCC (age ≥18 years; duration ≥1 year; Cough Severity Visual Analogue Scale score ≥40 mm). The primary efficacy periods 12 weeks (40-week extension; COUGH-1)...
Background: Multiple studies in the National Institute on Drug Abuse Clinical Trials Network (CTN) demonstrate strategies for conducting effective substance abuse treatment research with racial/ethnic minorities (REMs). Objectives: The objectives of this article are to describe lessons learned within CTN (1) enhance recruitment, retention, and other outcomes; (2) assess measurement equivalence; (3) use data analytic plans that yield more information. Method: This includes background...
Background MK-5475 is an investigational inhaled soluble guanylate cyclase stimulator hypothesised to avoid most side-effects of systemic vasodilation. Methods The phase 2 INSIGNIA-PAH ( NCT04732221 ) trial randomised adults with pulmonary arterial hypertension (PAH) on stable background therapy 1:1:1:1 once-daily dosing placebo, 32 µg, 100 µg or 380 via dry powder inhalation for 12 weeks. Objectives objectives were evaluate vascular resistance (PVR; primary), 6-min walk distance (6MWD;...
Background Behavioral intervention research has lagged behind biomedical in developing principles for defining, categorizing, identifying, reporting, and monitoring adverse events unanticipated problems. Purpose In this article we present a set of defining how they were applied large national multi-site family therapy study substance-using adolescents, The Brief Strategic Family Therapy (BSFT TM ) Effectiveness Study. Methods BSFT tested compares to Treatment as Usual (TAU) the treatment...
Abstract Purpose Objective cough frequency is used to assess efficacy of chronic (CC) treatments. The objective this study was explore the relationship between and cough-specific patient-reported outcomes (PROs) estimate a clinically meaningful change threshold (MCT) for frequency. Methods Data collected in phase 2b participants with refractory or unexplained CC were investigate 24-h (measured using an ambulatory monitor) PROs (i.e., severity visual analog scale, diary, Leicester Cough...
Background: The National Institute of Drug Abuse's Abuse Treatment Clinical Trials Network (CTN) was established to foster translation research into practice in substance abuse treatment settings. CTN provides a unique opportunity examine multi-site, translational clinical trials, the outcomes interventions targeting vulnerable subgroups women; comparative effectiveness gender-specific protocols reduce risk behaviors; and gender differences outcomes. Objectives: To review gender-related...