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Impactful clinical trials

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https://www.readbyqxmd.com/read/29792730/nivolumab-for-the-treatment-of-colorectal-cancer
#1
Kortnye Maureen Smith, Jayesh Desai
Despite a variety of therapies for advanced metastatic colorectal cancer being available, the outcomes in this malignancy remain sub-optimal. Immunotherapy has been slow to impact the management of this patient group. Checkpoint inhibitors, such as nivolumab, have had disappointing results when used broadly. However, for the subset of patients with microsatellite unstable colorectal cancer the use of checkpoint inhibitors such as nivolumab appears to be transformative, and will provide a new therapeutic option for patient with advanced disease...
May 24, 2018: Expert Review of Anticancer Therapy
https://www.readbyqxmd.com/read/29792074/lessons-learned-conducting-a-multi-center-trial-with-a-military-population-the-tinnitus-retraining-therapy-trial
#2
Roberta W Scherer, Leonora D Sensinger, Benigno Sierra-Irizarry, Craig Formby
Background The Tinnitus Retraining Therapy Trial (TRTT), a randomized, placebo-controlled, multi-center trial, evaluated the efficacy of tinnitus retraining therapy and its individual components, tinnitus-specific educational counseling and sound therapy versus the standard of care, in military practice to improve study participants' quality of life. The trial was conducted at six US military hospitals to take advantage of the greater prevalence of tinnitus in the military population. Methods During the trial, various challenges arose that were uniquely related to the military setting...
May 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29791021/immtac-anti-pd-1-combination-to-enhance-killing-of-cancer-cells-by-reversing-treg-mediated-immunosuppression
#3
Huanling Zhang, Yanyan Li, Xiaoping Liu, Zhaoduan Liang, Mengyong Yan, Qiang Liu, Anan Chen, Yifeng Bao, Chengzhi Zhou, Shiyue Li, Cassian Yee, Yi Li
Recently, bi-functional molecules that can redirect immune effectors to tumor cells have emerged as potentially robust mediators of tumor regression in clinical trials. Two modalities, in particular, bi-specific antibodies for T cell redirection and activation (BiTe) and immune-mobilizing monoclonal T-cell receptors against cancer (ImmTAC) are being evaluated in efficacy studies as 'off-the-shelf' reagents. Optimal therapy will require an understanding and means to address regulatory mechanisms of limiting efficacy...
May 23, 2018: Immunology
https://www.readbyqxmd.com/read/29790477/biolimus-a9-polymer-free-coated-stents-in-high-bleeding-risk-patients-undergoing-complex-pci-evidence-from-the-leaders-free-randomised-clinical-trial
#4
Janusz Lipiecki, Philippe Brunel, Marie-Claude Morice, Christan Roguelov, Simon J Walsh, Gert Richardt, Pedro Eerdmans, Robaayah Zambahari, Jacques Berland, Samuel Copt, Hans-Peter Stoll, Philip Urban
AIMS: The LEADERS FREE trial has demonstrated that a polymer-free Biolimus A9-coated stent (BA9-DCS) is superior to a bare metal stent (BMS) for high bleeding risk (HBR) patients when treated with one month of dual antiplatelet therapy (DAPT). This analysis aimed to determine the impact of PCI procedure complexity on the two-year results. METHODS AND RESULTS: Six hundred and sixty-seven (667) patients enrolled in the LEADERS FREE (BA9-DCS 346, BMS 321) underwent a complex PCI, defined by one or more of eight characteristics: total stent length ≥60 mm, ≥3 vessels or lesions treated, ≥3 stents implanted, bifurcation lesion treated with ≥2 stents, chronically occluded, restenotic or saphenous vein graft lesion...
May 23, 2018: EuroIntervention
https://www.readbyqxmd.com/read/29789664/the-bet-bromodomain-inhibitor-apabetalone-induces-apoptosis-of-latent-hiv-1-reservoir-cells-following-viral-reactivation
#5
Xuan-Xuan Zhang, Jian Lin, Tai-Zhen Liang, Heng Duan, Xing-Hua Tan, Bao-Min Xi, Lin Li, Shu-Wen Liu
The persistence of latent HIV-1 reservoirs throughout combination antiretroviral therapy (cART) is a major barrier on the path to achieving a cure for AIDS. It has been shown that bromodomain and extra-terminal (BET) inhibitors could reactivate HIV-1 latency, but restrained from clinical application due to their toxicity and side effects. Thus, identifying a new type of BET inhibitor with high degrees of selectivity and safety is urgently needed. Apabetalone is a small-molecule selective BET inhibitor specific for second bromodomains, and has been evaluated in phase III clinical trials that enrolled patients with high-risk cardiovascular disorders, dyslipidemia, and low HDL cholesterol...
May 22, 2018: Acta Pharmacologica Sinica
https://www.readbyqxmd.com/read/29789411/heliox-adjunct-therapy-for-neonates-with-congenital-diaphragmatic-hernia
#6
Audra C Wise, Mallory A Boutin, Ellen M Knodel, James A Proudfoot, Brian P Lane, Marva L Evans, Denise M Suttner, Amy L Kimball
BACKGROUND: Congenital diaphragmatic hernia remains a complex disease with significant morbidity and mortality. Hypercarbia is a common derangement in this population, which often requires escalating ventilator support. By decreasing airway turbulence and enhancing CO2 removal, inhaled helium-oxygen mixture (heliox) has the potential to improve ventilation and thereby decrease ventilator support and its associated lung injury. METHODS: Retrospective cohort review of all neonates with congenital diaphragmatic hernia treated at Rady Children's Hospital San Diego during 2011-2015...
May 22, 2018: Respiratory Care
https://www.readbyqxmd.com/read/29788982/tisu-extracorporeal-shockwave-lithotripsy-as-first-treatment-option-compared-with-direct-progression-to-ureteroscopic-treatment-for-ureteric-stones-study-protocol-for-a-randomised-controlled-trial
#7
Samuel McClinton, Sarah Cameron, Kathryn Starr, Ruth Thomas, Graeme MacLennan, Alison McDonald, Thomas Lam, James N'Dow, Mary Kilonzo, Robert Pickard, Ken Anson, Frank Keeley, Neil Burgess, Charles Terry Clark, Sara MacLennan, John Norrie
BACKGROUND: Urinary stone disease is very common with an estimated prevalence among the general population of 2-3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients' quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an intervention...
May 22, 2018: Trials
https://www.readbyqxmd.com/read/29788920/a-focus-group-study-to-understand-biases-and-confounders-in-a-cluster-randomized-controlled-trial-on-low-back-pain-in-primary-care-in-norway
#8
Erik L Werner, Ida Løchting, Kjersti Storheim, Margreth Grotle
BACKGROUND: Cluster randomized controlled trials are often used in research in primary care but creates challenges regarding biases and confounders. We recently presented a study on low back pain from primary care in Norway with equal effects in the intervention and the control group. In order to understand the specific mechanisms that may produce biases in a cluster randomized trial we conducted a focus group study among the participating health care providers. The aim of this study was to understand how the participating providers themselves influenced on the study and thereby possibly on the results of the cluster randomized controlled trial...
May 22, 2018: BMC Family Practice
https://www.readbyqxmd.com/read/29788732/the-current-application-of-acosog-z0011-trial-results-is-further-implementation-of-sentinel-lymph-node-intra-operative-histopathological-examination-mandatory-in-breast-cancer-patients-a-single-centre-analysis
#9
T Nowikiewicz, W Zegarski, K Pagacz, M Nowacki, A Morawiec-Sztandera, I Glowacka-Mrotek, M Sowa, M Biedka, A Kolacinska
The main objective of the ACOSOG Z0011 trial was to determine the impact of abandoning complete axillary lymph node dissection (ALND) on survival of breast cancer patients with sentinel node lymph (SLN) metastasis in whom breast conserving therapy (BCT) had been performed. The aim of our study was to assess the clinical value of intra-operative histopathological examination of SLN. Our study comprised 1284 invasive breast cancer patients in whom sentinel lymph node biopsy (SLNB) was carried out. SLN intra-operative histopathological assessment was routinely performed in patients treated within the first period (07...
March 14, 2018: Neoplasma
https://www.readbyqxmd.com/read/29788260/impact-of-obesity-on-short-and-intermediate-term-outcomes-in-inflammatory-bowel-diseases-pooled-analysis-of-placebo-arms-of-infliximab-clinical-trials
#10
Siddharth Singh, James Proudfoot, Ronghui Xu, William J Sandborn
Background and aims: To assess whether obesity may affect natural history of inflammatory bowel diseases (IBD), we conducted an individual participant data (IPD) pooled analysis of placebo arms, using data from clinical trials of infliximab in IBD and using the Yale Open Data Access (YODA) Project. Methods: We obtained IPD from 4 placebo-controlled trials of infliximab in adults with IBD (ACCENT-I and ACCENT-II; ACT-1 and ACT-2). Patients were categorized into quartiles based on body mass index (BMI) or weight at time of trial entry...
May 18, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29788156/systemic-inflammation-markers-after-simplification-to-atazanavir-ritonavir-plus-lamivudine-in-virologically-suppressed-hiv-1-infected-patients-atlas-m-substudy
#11
Simone Belmonti, Francesca Lombardi, Eugenia Quiros-Roldan, Alessandra Latini, Antonella Castagna, Alberto Borghetti, Gianmaria Baldin, Arturo Ciccullo, Roberto Cauda, Andrea De Luca, Simona Di Giambenedetto
Background: Biomarkers of systemic inflammation predict non-AIDS events and overall mortality in virologically suppressed HIV-1-infected patients. Objectives: To determine whether switching to a dual antiretroviral maintenance therapy was associated with modification of biomarkers of systemic inflammation as compared with continuation of successful standard triple therapy. Methods: In this substudy of the randomized ATLAS-M trial, we compared in virologically suppressed patients the impact at 1 year of simplification to a dual therapy with atazanavir/ritonavir plus lamivudine versus maintaining atazanavir/ritonavir plus two NRTI triple therapy on markers of systemic inflammation...
April 17, 2018: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29788137/inflammatory-bowel-disease-telemedicine-clinical-trial-impact-of-educational-text-messages-on-disease-specific-knowledge-over-1-year
#12
Ameer Abutaleb, Andrea Buchwald, Kenechukwu Chudy-Onwugaje, Patricia Langenberg, Miguel Regueiro, David A Schwartz, J Kathleen Tracy, Leyla Ghazi, Seema A Patil, Sandra M Quezada, Katharine M Russman, Charlene C Quinn, Guruprasad Jambaulikar, Dawn B Beaulieu, Sara Horst, Raymond K Cross
Background: Effective treatments are available for patients with inflammatory bowel disease (IBD); however, suboptimal outcomes occur and are often linked to patients' limited disease knowledge. The aim of this analysis was to determine if delivery of educational messages through a telemedicine system improves IBD knowledge. Methods: TELEmedicine for Patients with IBD (TELE-IBD) was a randomized controlled trial with visits at baseline, 6 months, and 12 months; patient knowledge was a secondary aim of the study...
May 18, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29788083/evaluation-of-an-intensive-interdisciplinary-pain-treatment-based-on-acceptance-and-commitment-therapy-for-adolescents-with-chronic-pain-and-their-parents-a-nonrandomized-clinical-trial
#13
Mike K Kemani, Marie Kanstrup, Abbie Jordan, Line Caes, Jeremy Gauntlett-Gilbert
Objective: Parental factors are central in the development and maintenance of chronic pain in youths. Only a handful of studies have investigated the impact of psychological treatments for pediatric chronic pain on parental factors, and the relationships between changes in parental and adolescent factors. In the current study, we evaluated the effects of an intensive interdisciplinary pain treatment (IIPT) program based on Acceptance and Commitment Therapy (ACT) for adolescents with chronic pain, on adolescent and parental variables, and the relationship between parental psychological flexibility and adolescent pain acceptance...
May 17, 2018: Journal of Pediatric Psychology
https://www.readbyqxmd.com/read/29787892/the-role-of-bisphosphonates-or-denosumab-in-light-of-the-availability-of-new-therapies-for-prostate-cancer
#14
REVIEW
Fred Saad, Cora N Sternberg, Peter F A Mulders, Daniela Niepel, Bertrand F Tombal
Most men with advanced prostate cancer will develop bone metastases, which have a substantial impact on quality of life. Bone metastases can lead to skeletal-related events (SREs), which place a burden on patients and healthcare systems. For men with castration-resistant prostate cancer (CRPC) and bone metastases, the treatment landscape has evolved rapidly over the past few years. The relatively recent approvals of the hormonal agents abiraterone acetate and enzalutamide, second-line chemotherapy cabazitaxel, and the radiopharmaceutical radium-223 dichloride (radium-223), have provided clinicians with a greater choice of treatments...
May 3, 2018: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/29787513/real-time-ultrasound-assisted-gluteal-fat-grafting
#15
Alvaro Luiz Cansancao, Alexandra Condé-Green, Rafael A Vidigal, Ricardo Luis Rodriguez, Richard A D'Amico
BACKGROUND: Outcomes in primary breast augmentation depend on careful preoperative planning and clear communication between patient and surgeon. Three-dimensional imaging with computer simulation is an evolving technology with the potential to enhance the preoperative consultation for patients considering primary breast augmentation. The purpose of this study was to prospectively evaluate the impact of three-dimensional imaging with computer simulation on patient-reported and objective, mammometric outcomes in women undergoing primary breast augmentation...
May 16, 2018: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/29787421/the-impact-of-saphenous-vein-sparing-during-inguinal-lymphadenectomy-on-postoperative-morbidity-in-women-with-vulval-cancer-an-updated-per-groin-meta-analysis-of-short-term-outcomes
#16
Anastasios Tranoulis, Alexandros Laios, George Theophilou, Konstantinos Bramis, Sean Kehoe
OBJECTIVE: Inguinofemoral lymphadenectomy (IFL) is included in the standard surgical management of early-stage vulval cancer (VC) but is often accompanied by surgical complications. Efforts have been made to limit the postoperative morbidity by adopting more conservative IFL techniques without compromising the surgical outcomes. Saphenous vein (SV) preservation during IFL for VC appears to reduce the incidence of postoperative complications including lymphedema. To ascertain the efficacy of SV preservation, we aimed to revisit the impact of SV preservation on short-term per groin complications by updating on a previous meta-analysis to further guide current clinical practice...
May 22, 2018: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/29787389/liposomal-bupivacaine-does-not-reduce-inpatient-opioid-prescription-or-related-complications-after-knee-arthroplasty-a-database-analysis
#17
Lukas Pichler, Jashvant Poeran, Nicole Zubizarreta, Crispiana Cozowicz, Eric C Sun, Madhu Mazumdar, Stavros G Memtsoudis
BACKGROUND: Although some trials suggest benefits of liposomal bupivacaine, data on real-world use and effectiveness is lacking. This study analyzed the impact of liposomal bupivacaine use (regardless of administration route) on inpatient opioid prescription, resource utilization, and opioid-related complications among patients undergoing total knee arthroplasties with a peripheral nerve block. It was hypothesized that liposomal bupivacaine has limited clinical influence on the studied outcomes...
May 21, 2018: Anesthesiology
https://www.readbyqxmd.com/read/29785683/targeted-therapies-and-adverse-drug-reactions-in-oncology-the-role-of-clinical-pharmacist-in-pharmacovigilance
#18
G Fornasier, M Taborelli, S Francescon, J Polesel, M Aliberti, P De Paoli, P Baldo
Background The majority of adverse drug reactions (ADRs) reported in the summary of product characteristics (SPCs) are based on pivotal clinical trials, performed under controlled conditions and with selected patients. Objectives (1) to observe ADRs in the real-world setting and to evaluate if the supervision of the pharmacist impacts on the management of ADRs and on the satisfaction of patients; (2) to sensitise health professionals and patients on the need to increase the reporting of ADRs, in compliance with Pharmacovigilance...
May 21, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/29785673/the-impact-of-transcranial-direct-current-stimulation-tdcs-on-bipolar-depression-mania-and-euthymia-a-systematic-review-of-preliminary-data
#19
Clément Dondé, Nicholas H Neufeld, Pierre A Geoffroy
The neurobiological basis of bipolar disorders (BD) has received increased attention and several brain regions and brain circuits have been correlated with clinical symptoms. These brain regions and circuits may represent targets for neuromodulation techniques such as transcranial Direct Current Stimulation (tDCS). We systematically reviewed the literature to explore the risks and benefits of tDCS in BD and examined all mood states. Following the PRISMA guidelines, a systematic literature search using several databases was performed from April 2002 to June 2017...
May 21, 2018: Psychiatric Quarterly
https://www.readbyqxmd.com/read/29785045/an-initial-study-on-the-effect-of-functional-electrical-stimulation-in-erectile-dysfunction-a-randomized-controlled-trial
#20
Cristiane Carboni, Alexandre Fornari, Karoline C Bragante, Marcio A Averbeck, Patrícia Vianna da Rosa, Rodrigo Della Mea Plentz
Erectile dysfunction (ED) affects approximately 150 million men worldwide. Functional electrical stimulation (FES) therapy has shown a high regenerative capacity for smooth muscle cells and, therefore, is being increasingly adopted. FES can be a beneficial treatment option when the cause of ED is related to degeneration of cavernous smooth muscle. To evaluate the impact of FES on erectile function in men with erectile dysfunction. Twenty-two patients with ED participated in this randomized clinical trial. Participants were randomly assigned to two groups: intervention (IG) or control (CG)...
May 22, 2018: International Journal of Impotence Research
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