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Impactful clinical trials

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https://www.readbyqxmd.com/read/29332050/supplemental-retinal-carotenoids-enhance-memory-in-healthy-individuals-with-low-levels-of-macular-pigment-in-a-randomized-double-blind-placebo-controlled-clinical-trial
#1
Rebecca Power, Robert F Coen, Stephen Beatty, Riona Mulcahy, Rachel Moran, Jim Stack, Alan N Howard, John M Nolan
BACKGROUND: There is a biologically plausible rationale whereby the dietary carotenoids lutein (L), zeaxanthin (Z), and meso-zeaxanthin (MZ), which are collectively referred to as macular pigment (MP) in the central retina (macula), support the maintenance of cognition via their antioxidant and anti-inflammatory properties. OBJECTIVE: To investigate the impact of supplemental L, Z, and MZ on memory, executive function, and verbal fluency among healthy individuals with low MP levels...
2018: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/29331986/sex-differences-in-impact-of-coronary-artery-calcification-to-predict-coronary-artery-disease
#2
Yoko M Nakao, Yoshihiro Miyamoto, Masahiro Higashi, Teruo Noguchi, Mitsuru Ohishi, Isao Kubota, Hiroyuki Tsutsui, Tomohiro Kawasaki, Yutaka Furukawa, Michihiro Yoshimura, Hideaki Morita, Kunihiro Nishimura, Akiko Kada, Yoichi Goto, Tomonori Okamura, Chuwa Tei, Hitonobu Tomoike, Hiroaki Naito, Satoshi Yasuda
OBJECTIVE: To assess sex-specific differences regarding use of conventional risks and coronary artery calcification (CAC) to detect coronary artery disease (CAD) using coronary CT angiography (CCTA). METHODS: The Nationwide Gender-specific Atherosclerosis Determinants Estimation and Ischemic Cardiovascular Disease Prospective Cohort study is a prospective, multicentre, nationwide cohort study. Candidates with suspected CAD aged 50-74 years enrolled from 2008 to 2012...
January 13, 2018: Heart: Official Journal of the British Cardiac Society
https://www.readbyqxmd.com/read/29331971/a-study-protocol-for-a-non-randomised-comparison-trial-evaluating-the-feasibility-and-effectiveness-of-a-mobile-cognitive-behavioural-programme-with-integrated-coaching-for-anxious-adults-in-primary-care
#3
Eva Szigethy, Francis Solano, Meredith Wallace, Dina L Perry, Lauren Morrell, Kathryn Scott, Megan Jones Bell, Megan Oser
INTRODUCTION: Generalised anxiety disorder (GAD) and subclinical GAD are highly prevalent in primary care. Unmanaged anxiety worsens quality of life in patients seen in primary care practices and leads to increased medical utilisation and costs. Programmes that teach patients cognitive-behavioural therapy (CBT) techniques have been shown to improve anxiety and to prevent the evolution of anxiety symptoms to disorders, but access and engagement have hampered integration of CBT into medical settings...
January 13, 2018: BMJ Open
https://www.readbyqxmd.com/read/29331381/clinical-outcomes-of-first-line-abiraterone-acetate-or-enzalutamide-for-metastatic-castration-resistant-prostate-cancer-after-androgen-deprivation-therapy%C3%A2-docetaxel-or-adt-alone-for-metastatic-hormone-sensitive-prostate-cancer
#4
Edoardo Francini, Steven Yip, Shubidito Ahmed, Haocheng Li, Luke Ardolino, Carolyn P Evan, Marina Kaymakcalan, Grace K Shaw, Philip W Kantoff, Mary-Ellen Taplin, Nimira S Alimohamed, Anthony M Joshua, Daniel Y C Heng, Christopher J Sweeney
BACKGROUND: The CHAARTED (ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer) and STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy) trials showed that the addition of docetaxel (D) to androgen deprivation therapy (ADT) prolonged longevity of men with metastatic hormone-sensitive prostate cancer (mHSPC). However, the impact of upfront D on subsequent therapies is still unexplored. As abiraterone acetate (AA) and enzalutamide (E) are the most commonly used first-line treatment for metastatic castration-resistant prostate cancer (mCRPC), we aimed to assess whether they maintained their efficacy after ADT+D versus ADT alone...
December 27, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/29330855/getting-innovative-therapies-faster-to-patients-at-the-right-dose-impact-of-quantitative-pharmacology-towards-first-registration-and-expanding-therapeutic-use
#5
Satyaprakash Nayak, Oliver Sander, Nidal Al-Huniti, Dinesh de Alwis, Anne Chain, Marylore Chenel, Soujanya Sunkaraneni, Shruti Agrawal, Neeraj Gupta, Sandra A G Visser
Quantitative pharmacology (QP) applications in translational medicine, drug-development, and therapeutic use were crowd-sourced by the ASCPT Impact and Influence initiative. Highlighted QP case studies demonstrated faster access to innovative therapies for patients through 1) rational dose selection for pivotal trials; 2) reduced trial-burden for vulnerable populations; or 3) simplified posology. Critical success factors were proactive stakeholder engagement, alignment on the value of model-informed approaches, and utilizing foundational clinical pharmacology understanding of the therapy...
January 13, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29330767/ivabradine-for-the-treatment-of-postural-orthostatic-tachycardia-syndrome-a-systematic-review
#6
REVIEW
Megan E Gee, Alicia K Watkins, Jamie N Brown, Emily J A Young
INTRODUCTION: Postural orthostatic tachycardia syndrome (POTS) impacts millions of patients, but there is currently no gold standard treatment for this condition. Ivabradine is a novel heart rate (HR) lowering agent that acts on the sinoatrial node cells by selectively inhibiting the If-current. OBJECTIVE: The objective of this systematic review is to evaluate the evidence for the efficacy and safety of ivabradine for the treatment of POTS. METHODS: MEDLINE (from 1956 to August 2017) and EMBASE (from 1957 to August 2017) were queried with the following search term: "postural orthostatic tachycardia syndrome" OR "postural tachycardia syndrome" OR "chronic orthostatic intolerance" AND "ivabradine...
January 12, 2018: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
https://www.readbyqxmd.com/read/29330646/potential-impact-of-sglt2-inhibitors-on-left-ventricular-diastolic-function-in-patients-with-diabetes-mellitus
#7
REVIEW
Hidekazu Tanaka, Ken-Ichi Hirata
The pathogenesis of diabetes mellitus (DM)-related cardiac dysfunction is thought to be multifactorial, and possibly a key factor for the development of heart failure with preserved ejection fraction (HFpEF) in patients with DM and preserved left ventricular (LV) ejection fraction. Currently, there is no effective treatment for HFpEF, which is presented as LV diastolic dysfunction. Furthermore, it is well known that, in addition to DM, hypertension and overweight/obesity are also important factors associated with HFpEF...
January 12, 2018: Heart Failure Reviews
https://www.readbyqxmd.com/read/29330208/neuroendocrine-tumor-heterogeneity-adds-uncertainty-to-the-world-health-organization-2010-classification-real-world-data-from-the-spanish-tumor-registry-r-getne
#8
Barbara Nuñez-Valdovinos, Alberto Carmona-Bayonas, Paula Jimenez-Fonseca, Jaume Capdevila, Ángel Castaño-Pascual, Marta Benavent, Jose Javier Pi Barrio, Alex Teule, Vicente Alonso, Ana Custodio, Monica Marazuela, Ángel Segura, Adolfo Beguiristain, Marta Llanos, Maria Purificacion Martinez Del Prado, Jose Angel Diaz-Perez, Daniel Castellano, Isabel Sevilla, Carlos Lopez, Teresa Alonso, Rocio Garcia-Carbonero
BACKGROUND: Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) are a complex family of tumors of widely variable clinical behavior. The World Health Organization (WHO) 2010 classification provided a valuable tool to stratify neuroendocrine neoplasms (NENs) in three prognostic subgroups based on the proliferation index. However, substantial heterogeneity remains within these subgroups, and simplicity sometimes entails an ambiguous and imprecise prognostic stratification. The purpose of our study was to evaluate the prognostic impact of histological differentiation within the WHO 2010 grade (G) 1/G2/G3 categories, and explore additional Ki-67 cutoff values in GEP-NENs...
January 12, 2018: Oncologist
https://www.readbyqxmd.com/read/29330202/high-risk-tp53-mutations-are-associated-with-extra-nodal-extension-ene-in-oral-cavity-squamous-cell-carcinoma-oscc
#9
Vlad C Sandulache, Chieko Michikawa, Pranav Kataria, Frederico O Gleber-Netto, Diana Bell, Sanchit Trivedi, Xiayu Rao, Jing Wang, Mei Zhao, Samar A Jasser, Jeffrey N Myers, Curtis R Pickering
PURPOSE:   Development of extra-nodal extension (ENE) has been associated with poor survival in patients with oral cavity squamous cell carcinoma (OSCC). Here we sought to confirm the role of ENE as a poor prognostic factor, and identify genomic and epigenetic markers of ENE in order to develop a predictive model and improve treatment selection. EXPERIMENTAL DESIGN: An institutional cohort (University of Texas MD Anderson Cancer Center) was utilized to confirm the impact of ENE on clinical outcomes and evaluate the genomic signature of primary and ENE containing tissue...
January 12, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29330082/clinical-trials-recruitment-planning-a-proposed-framework-from-the-clinical-trials-transformation-initiative
#10
Grant D Huang, Jonca Bull, Beth Harper, Elizabeth Mahon, Kelly McKee, Jamie N Roberts
Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies...
January 9, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29329923/different-protein-composition-of-low-calorie-diet-differently-impacts-adipokine-profile-irrespective-of-weight-loss-in-overweight-and-obese-women
#11
R Mateo-Gallego, I Lamiquiz-Moneo, S Perez-Calahorra, V Marco-Benedí, A M Bea, L Baila-Rueda, M Laclaustra, J L Peñalvo, F Civeira, A Cenarro
BACKGROUND AND AIMS: High-protein (HP) diets have shown benefits in cardiometabolic markers such as insulin or triglycerides but the responsible mechanisms are not known. We aimed to assess the effect of three energy-restricted diets with different protein contents (20%, 27%, and 35%; ∼80% coming from animal source) on plasma adipokine concentration and its association with changes in cardiometabolic markers. METHODS: Seventy-six women (BMI 32.8 ± 2.93) were randomized to one of three calorie-reduced diets, with protein, 20%, 27%, or 35%; carbohydrates, 50%, 43%, or 35%; and fat, 30%, for 3 months...
November 4, 2017: Nutrition, Metabolism, and Cardiovascular Diseases: NMCD
https://www.readbyqxmd.com/read/29329567/modified-pilates-as-an-adjunct-to-standard-physiotherapy-care-for-urinary-incontinence-a-mixed-methods-pilot-for-a-randomised-controlled-trial
#12
Adi Lausen, Louise Marsland, Samantha Head, Joanna Jackson, Berthold Lausen
BACKGROUND: Urinary incontinence (UI) is a distressing condition affecting at least 5 million women in England and Wales. Traditionally, physiotherapy for UI comprises pelvic floor muscle training, but although evidence suggests this can be effective it is also recognised that benefits are often compromised by patient motivation and commitment. In addition, there is increasing recognition that physical symptoms alone are poor indicators of the impact of incontinence on individuals' lives...
January 12, 2018: BMC Women's Health
https://www.readbyqxmd.com/read/29329559/simplification-of-medications-prescribed-to-long-term-care-residents-simpler-study-protocol-for-a-cluster-randomised-controlled-trial
#13
Janet K Sluggett, Esa Y H Chen, Jenni Ilomäki, Megan Corlis, Sarah N Hilmer, Jan Van Emden, Choon Ean Ooi, Kim-Huong Nguyen, Tracy Comans, Michelle Hogan, Tessa Caporale, Susan Edwards, Lyntara Quirke, Allan Patching, J Simon Bell
BACKGROUND: Complex medication regimens are highly prevalent in residential aged care facilities (RACFs). Strategies to reduce unnecessary complexity may be valuable because complex medication regimens can be burdensome for residents and are costly in terms of nursing time. The aim of this study is to investigate application of a structured process to simplify medication administration in RACFs. METHODS: SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) is a non-blinded, matched-pair, cluster randomised controlled trial of a single multidisciplinary intervention to simplify medication regimens...
January 12, 2018: Trials
https://www.readbyqxmd.com/read/29329286/is-the-proportional-recovery-rule-applicable-to-the-lower-limb-after-a-first-ever-ischemic-stroke
#14
Janne M Veerbeek, Caroline Winters, Erwin E H van Wegen, Gert Kwakkel
OBJECTIVE: To investigate (a) the applicability of the proportional recovery rule of spontaneous neurobiological recovery to motor function of the paretic lower extremity (LE); and (b) the presence of fitters and non-fitters of this prognostic rule poststroke. When present, the clinical threshold for fitting nor non-fitting would be determined, as well as within-subject generalizability to the paretic upper extremity (UE). METHODS: Prospective cohort study in which the Fugl-Meyer Assessment (FMA)-LE and FMA-UE were measured <72 hours and 6 months poststroke...
2018: PloS One
https://www.readbyqxmd.com/read/29327997/mechanical-thrombectomy-in-basilar-artery-occlusion-influence-of-reperfusion-on-clinical-outcome-and-impact-of-the-first-line-strategy-adapt-vs-stent-retriever
#15
Benjamin Gory, Mikael Mazighi, Raphael Blanc, Julien Labreuche, Michel Piotin, Francis Turjman, Bertrand Lapergue
OBJECTIVE Several randomized trials have been focused on patients with anterior circulation stroke, whereas few data on posterior circulation stroke are available. Thus, new mechanical thrombectomy (MT) strategies, including a direct-aspiration first-pass technique (ADAPT), remain to be evaluated in basilar artery occlusion (BAO) patients. The authors here assessed the influence of reperfusion on outcome in BAO patients and examined whether ADAPT improves the reperfusion rate compared with stent retriever devices...
January 12, 2018: Journal of Neurosurgery
https://www.readbyqxmd.com/read/29327978/in-vivo-cyp3a-activity-in-palliative-care-patients-study-protocol-for-a-single-arm-prospective-trial
#16
Marcus J P Geist, Hubert J Bardenheuer, Jürgen Burhenne, Gerd Mikus
BACKGROUND: Drug interactions are a common cause for escalation of debilitating symptoms in palliative care patients. CYP3A is the most relevant CYP enzyme in humans involved in metabolism of about half of all available pharmaceuticals. OBJECTIVE: To increase knowledge about the CYP3A enzyme and the impact of drug interactions on its activity to improve dosing in palliative care patients. DESIGN: The prospective clinical trial uses a secure method of analyzing CYP3A activity in humans: Administration of a marker substance followed by the determination of its blood concentrations as well as the concentrations of its metabolite at certain points of time and corresponding metabolic clearance calculations...
January 12, 2018: Journal of Palliative Medicine
https://www.readbyqxmd.com/read/29327261/chronic-rejection-after-intestinal-transplant-where-are-we-in-order-to-avert-it
#17
REVIEW
Augusto Lauro, Mihai Oltean, Ignazio R Marino
Chronic rejection affects the long-term survival of all solid organ transplants and, among intestinal allografts, occurs in up to 10% of the recipients. The insidious clinical evolution of the chronic allograft enteropathy, the absence of noninvasive biomarkers, and the late endoscopic findings delay its diagnosis. No pharmacological approach has been proven effective, and allograft removal nowadays still represents the only available therapy. The inclusion of the liver in the visceral allograft appears to be the only intervention affecting the development of chronic rejection, as revealed by large-center studies and registry reports...
January 11, 2018: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/29326332/the-impact-of-digital-health-technologies-on-tuberculosis-treatment-a-systematic-review
#18
Brian Kermu Ngwatu, Ntwali Placide Nsengiyumva, Olivia Oxlade, Benjamin Mappin-Kasirer, Nhat Linh Nguyen, Ernesto Jaramillo, Dennis Falzon, Kevin Schwartzman
Digital technologies are increasingly harnessed to support treatment of persons with tuberculosis (TB). Since in-person directly observed treatment (DOT) can be resource intensive and challenging to implement, these technologies may have the potential to improve adherence and clinical outcomes. We reviewed the effect of these technologies on TB treatment adherence and patient outcomes.We searched several bibliographical databases for studies reporting the effect of digital interventions, including short message service (SMS), video-observed therapy (VOT) and medication monitors (MMs), to support treatment for active TB...
January 2018: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/29326318/long-term-benefits-of-airway-clearance-in-bronchiectasis-a-randomised-placebo-controlled-trial
#19
Gerard Muñoz, Javier de Gracia, Maria Buxó, Antonio Alvarez, Montserrat Vendrell
Keeping airways clear of mucus by airway clearance techniques seems essential in bronchiectasis treatment, although no placebo-controlled trials or any studies lasting longer than 3 months have been conducted. We evaluate the efficacy of the ELTGOL (slow expiration with the glottis opened in the lateral posture) technique over a 1-year period in bronchiectasis patients with chronic expectoration in a randomised placebo-controlled trial.Patients were randomised to perform the ELTGOL technique (n=22) or placebo exercises (n=22) twice-daily (ClinicalTrials...
January 2018: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/29325660/impact-of-the-lactation-advice-through-texting-can-help-latch-trial-on-time-to-first-contact-and-exclusive-breastfeeding-among-wic-participants
#20
Josefa L Martinez-Brockman, Nurit Harari, Sofia Segura-Pérez, Lori Goeschel, Valerie Bozzi, Rafael Pérez-Escamilla
OBJECTIVE: Determine the impact of a 2-way text messaging intervention on time to contact between participants and their breastfeeding peer counselors (BFPCs) and on exclusive breastfeeding (EBF) status at 2 weeks and 3 months postpartum. DESIGN: Multisite, single-blind, randomized, controlled trial. SETTING: Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) BFPC program. PARTICIPANTS: Low-income women (n = 174) participating in the WIC BFPC program...
January 2018: Journal of Nutrition Education and Behavior
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