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Landmark trial

Yves Lacasse, Ai-Yui M Tan, François Maltais, Jerry A Krishnan
Two landmark trials conducted more than 35 years ago provided scientific evidence that, under very specific circumstances, long-term oxygen therapy (LTOT) may prolong life. These two trials enrolled 290 patients with chronic obstructive pulmonary disease (COPD) and severe daytime hypoxemia documented by direct arterial blood gas measurement. From this moment, LTOT became a standard of care and the indications for oxygen therapy have expanded to include nocturnal oxygen therapy for isolated nocturnal oxygen desaturation, ambulatory oxygen to correct exercise-induced desaturation, and short-burst oxygen to relieve dyspnea...
March 16, 2018: American Journal of Respiratory and Critical Care Medicine
Tiffany L Gary-Webb, Elizabeth A Walker, Lindsey Realmuto, Alexandra Kamler, Jennifer Lukin, William Tyson, Olveen Carrasquillo, Linda Weiss
The Diabetes Prevention Program (DPP) landmark randomized trial demonstrated that participants with prediabetes could reduce their risk for type 2 diabetes by 58% if they achieved 5%-7% weight loss through healthy eating and increasing physical activity. The National DPP (NDPP) is a group intervention based on the DPP and has been widely disseminated by the Centers for Disease Control and Prevention (CDC) and many healthcare institutions. While data show that the program is effective in diverse populations, enrollment among men from low-income and minority communities is low...
March 1, 2018: American Journal of Men's Health
Katsuo Sekiguchi, Tomokazu Ushitani, Kosuke Sawa
Landmark-based goal-searching tasks that were similar to those for pigeons (Ushitani & Jitsumori, 2011) were provided to human participants to investigate whether they could learn and use multiple sources of spatial information that redundantly indicate the position of a hidden target in both an open field (Experiment 1) and on a computer screen (Experiments 2 and 3). During the training in each experiment, participants learned to locate a target in 1 of 25 objects arranged in a 5 × 5 grid, using two differently colored, arrow-shaped (Experiments 1 and 2) or asymmetrically shaped (Experiment 3) landmarks placed adjacent to the goal and pointing to the goal location...
March 8, 2018: Journal of Comparative Psychology
Neal A Chatterjee, E Kevin Heist
Cardiac resynchronization therapy (CRT) is an important therapeutic tool in the management of patients with heart failure and electrical dyssynchrony. In appropriately selected patients, landmark randomized controlled trials have demonstrated morbidity and mortality benefit beyond standard goal-directed medical therapy. Current guidelines emphasize the greatest clinical efficacy of CRT in patients with symptomatic heart failure, left bundle branch block, and wide QRS duration (> 150 ms). Other relevant considerations include the presence of atrial fibrillation, the presence of AV block, the etiology of cardiomyopathy, the presence of masked left-sided conduction delay, and the impact of comorbidities that might predict poor clinical response...
March 6, 2018: Current Treatment Options in Cardiovascular Medicine
Walid I Essayed, Prashin Unadkat, Ahmed Hosny, Sarah Frisken, Marcio S Rassi, Srinivasan Mukundan, James C Weaver, Ossama Al-Mefty, Alexandra J Golby, Ian F Dunn
OBJECTIVE Endoscopic endonasal approaches are increasingly performed for the surgical treatment of multiple skull base pathologies. Preventing postoperative CSF leaks remains a major challenge, particularly in extended approaches. In this study, the authors assessed the potential use of modern multimaterial 3D printing and neuronavigation to help model these extended defects and develop specifically tailored prostheses for reconstructive purposes. METHODS Extended endoscopic endonasal skull base approaches were performed on 3 human cadaveric heads...
March 2, 2018: Journal of Neurosurgery
Domenico Girelli, Fabiana Busti, Giacomo Marchi, Nicola Martinelli, Oliviero Olivieri
The idea of using small RNA fragments (oligonucleotides) for therapeutic purposes dates back to the 1990s, following the landmark discoveries on the mechanisms of gene silencing and RNA-interference (RNA-i). However, the first applications in medicine were hampered by difficulties in chemical stabilization and efficient delivery to target tissues. Recent advances in chemical manipulation of oligonucleotides have, at least partially, bypassed such obstacles. In particular, conjugation with ligands for specific receptors allows the selective uptake of oligonucleotides by critical cells (e...
March 1, 2018: Internal and Emergency Medicine
Michel P Hermans, Paul Valensi
PURPOSE OF REVIEW: The aim of this review is to describe in diabetic patients the determinants underlying atherogenic dyslipidemia, a complex dyslipidemia defined as the coexistence of fasting hypertriglyceridemia and low high-density lipoprotein cholesterol level. Atherogenic dyslipidemia is often comorbid with hyperglycemia in patients with the common form of type 2 diabetes mellitus (T2DM), namely that associated with obesity, insulin resistance, hyperinsulinemia and the metabolic syndrome phenotype...
April 2018: Current Opinion in Endocrinology, Diabetes, and Obesity
Loay Kassem, Kyrillus S Shohdy, Omar Abdel-Rahman
BACKGROUND: A major, yet precisely studied, shift has occurred in treatment of advanced hormone-sensitive prostate cancer (HSPC) by addition of docetaxel to androgen deprivation therapy (ADT) in the first-line. Recently, two landmark trials showed that abiraterone acetate (AA) can be an effective alternative along with ADT in the same setting. We implemented a network meta-analysis to compare safety and efficacy of both combinations. METHODS: PubMed database, ASCO and ESMO meeting library databases of all results published until June 2017 were searched using the keywords: "prostate cancer" AND "docetaxel" OR "abiraterone acetate"...
February 28, 2018: Current Medical Research and Opinion
Yared Hailemichael, Amber Woods, Tihui Fu, Qiuming He, Michael C Nielsen, Farah Hasan, Jason Roszik, Zhilan Xiao, Christina Vianden, Hiep Khong, Manisha Singh, Meenu Sharma, Faisal Faak, Derek Moore, Zhimin Dai, Scott M Anthony, Kimberly S Schluns, Padmanee Sharma, Victor H Engelhard, Willem W Overwijk
Anticancer vaccination is a promising approach to increase the efficacy of cytotoxic T lymphocyte-associated protein 4 (CTLA-4) and programmed death ligand 1 (PD-L1) checkpoint blockade therapies. However, the landmark FDA registration trial for anti-CTLA-4 therapy (ipilimumab) revealed a complete lack of benefit of adding vaccination with gp100 peptide formulated in incomplete Freund's adjuvant (IFA). Here, using a mouse model of melanoma, we found that gp100 vaccination induced gp100-specific effector T cells (Teffs), which dominantly forced trafficking of anti-CTLA-4-induced, non-gp100-specific Teffs away from the tumor, reducing tumor control...
February 26, 2018: Journal of Clinical Investigation
Ting-Hui Wu, Emily Han-Chung Hsiue, Jih-Hsiang Lee, Chia-Chi Lin, Wei-Yu Liao, Chao-Chi Ho, Jin-Yuan Shih, Chong-Jen Yu, James Chih-Hsin Yang
INTRODUCTION: The association between the response to first-line epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and survival in EGFR mutation-positive non-small-cell lung cancer (NSCLC) remains unclear. We studied the association between the response to first-line EGFR-TKIs and survival using Response Evaluation Criteria In Solid Tumors (RECIST) and maximal tumor shrinkage. MATERIALS AND METHODS: We analyzed data from patients with advanced EGFR mutation-positive NSCLC enrolled in first-line gefitinib and afatinib trials...
February 1, 2018: Clinical Lung Cancer
Lori Berard, Noreen Antonishyn, Kathryn Arcudi, Sarah Blunden, Alice Cheng, Ronald Goldenberg, Stewart Harris, Shelley Jones, Upender Mehan, James Morrell, Robert Roscoe, Rick Siemens, Michael Vallis, Jean-François Yale
It is currently estimated that 11 million Canadians are living with diabetes or prediabetes. Although hyperglycemia is associated with serious complications, it is well established that improved glycemic control reduces the risk of microvascular complications and can also reduce cardiovascular (CV) complications over the long term. The UKPDS and ADVANCE landmark trials have resulted in diabetes guidelines recommending an A1C target of ≤ 7.0% for most patients or a target of ≤ 6.5% to further reduce the risk of nephropathy and retinopathy in those with type 2 diabetes (T2D), if it can be achieved safely...
February 23, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Ergun Velidedeoglu, Marc W Cavaillé-Coll, Shukal Bala, Ozlem A Belen, Yan Wang, Renata Albrecht
BACKGROUND: Despite major advances in understanding the pathophysiology of antibody mediated rejection (AMR); prevention, diagnosis and treatment remain unmet medical needs. It appears that early T-cell mediated rejection (TCMR), de novo donor specific antibody (dnDSA) formation and AMR result from patient or physician initiated suboptimal immunosuppression, and represent landmarks in an ongoing process rather than separate events. METHODS: On April 12-13, 2017, the Food and Drug Administration (FDA) sponsored a public workshop on AMR in kidney transplantation to discuss new advances, importance of immunosuppressive medication nonadherence in dnDSA formation, associations between AMR, cellular rejection, changes in GFR, and challenges of clinical trial design for the prevention and treatment of AMR...
February 20, 2018: Transplantation
Deborah A Hall, Rajnikant L Mehta, Kathryn Fackrell
Purpose: The authors respond to a letter to the editor (Sabour, 2018) concerning the interpretation of validity in the context of evaluating treatment-related change in tinnitus loudness over time. Method: The authors refer to several landmark methodological publications and an international standard concerning the validity of patient-reported outcome measurement instruments. Results: The tinnitus loudness rating performed better against our reported acceptability criteria for (face and convergent) validity than did the tinnitus loudness matching test...
February 20, 2018: American Journal of Audiology
Cyril B Dousson
This review describes the current state of discovery of past most important nucleoside and nucleotide prodrugs in the treatment of hepatitis C virus infection as well as future potential drugs currently in discovery or clinical evaluation. I highlight first generation landmark prodrug compounds which have been the foundations of incremental improvements toward the discovery and approval milestone of Sofosbuvir. Sofosbuvir is the first nucleotide prodrug marketed for hepatitis C virus treatment and the backbone of current combination therapies...
January 2018: Antiviral Chemistry & Chemotherapy
Rupali Patnaik, Anjolie Chhabra, Rajeshwari Subramaniam, Mahesh K Arora, Devalina Goswami, Anurag Srivastava, Vuthaluru Seenu, Anita Dhar
BACKGROUND AND OBJECTIVES: Paravertebral block (PVB) is an established technique for providing anesthesia for breast surgery. The primary objective was to compare anatomical landmark technique (ALT) to the ultrasound-guided (USG) PVB block for providing surgical anesthesia. Secondary objectives included comparison of perioperative analgesia and complications. METHODS: This randomized, controlled, observer-blinded study included 72 females, aged 18 to 65 years, American Society of Anesthesiologists physical status I or II, undergoing elective unilateral breast surgery...
February 16, 2018: Regional Anesthesia and Pain Medicine
Vallerie V McLaughlin, Marius M Hoeper, Richard N Channick, Kelly M Chin, Marion Delcroix, Sean Gaine, Hossein-Ardeschir Ghofrani, Pavel Jansa, Irene M Lang, Sanjay Mehta, Tomás Pulido, B K S Sastry, Gérald Simonneau, Olivier Sitbon, Rogério Souza, Adam Torbicki, Victor F Tapson, Loïc Perchenet, Ralph Preiss, Pierre Verweij, Lewis J Rubin, Nazzareno Galiè
BACKGROUND: Registry data suggest that disease progression in pulmonary arterial hypertension (PAH) is indicative of poor prognosis. However, the prognostic relevance of PAH-related morbidity has not been formally evaluated in randomized controlled trials. OBJECTIVES: The purpose of these analyses was to assess the impact of morbidity events on the risk of subsequent mortality using the landmark method and data from the SERAPHIN and GRIPHON studies. METHODS: For each study, the risk of all-cause death up to the end of the study was assessed from the landmark time point (months 3, 6, and 12) according to whether a patient had experienced a primary endpoint morbidity event before the landmark...
February 20, 2018: Journal of the American College of Cardiology
Joshua C Berkowitz, Joanna Stein-Fishbein, Sundas Khan, Richard Furie, Keith S Sultan
AIM: To describe trends of combination therapy (CT) of infliximab (IFX) and immunomodulator (IMM) for inflammatory bowel disease (IBD) in the community setting. METHODS: A retrospective study was conducted of all IBD patients referred for IFX infusion to our community infusion center between 04/01/01 and 12/31/14. CT was defined as use of IFX with either azathioprine, 6-mercaptopurine, or methotrexate. We analyzed trends of CT usage overall, for Crohn's disease (CD) and ulcerative colitis (UC), and for the subgroups of induction patients...
February 6, 2018: World Journal of Gastrointestinal Pharmacology and Therapeutics
Md Kamal Hossain, Kamrun Nahar, Osaana Donkor, Vasso Apostolopoulos
Prostate cancer (PC) is a common malignancy among elderly males and is noncurable once it becomes metastatic. In recent years, a number of antigen-delivery systems have emerged as viable and promising immunotherapeutic agents against PC. The approval of sipuleucel-T by the US FDA for the treatment of males with asymptomatic or minimally symptomatic castrate resistant PC was a landmark in cancer immunotherapy, making this the first approved immunotherapeutic. A number of vaccines are under clinical investigation, each having its own set of advantages and disadvantages...
February 1, 2018: Immunotherapy
Karthikeyan Kallidaikurichi Srinivasan, Anne-Marie Leo, Gabriella Iohom, Frank Loughnane, Peter J Lee
Background and Aims: Routine use of pre-procedural ultrasound guided midline approach has not shown to improve success rate in administering subarachnoid block. The study hypothesis was that the routine use of pre-procedural (not real time) ultrasound-guided paramedian spinals at L5-S1 interspace could reduce the number of passes (i.e., withdrawal and redirection of spinal needle without exiting the skin) required to enter the subarachnoid space when compared to the conventional landmark-guided midline approach...
January 2018: Indian Journal of Anaesthesia
André L N Gobatto, Bruno A M P Besen, Mino Cestari, Paolo Pelosi, Luiz M S Malbouisson
INTRODUCTION: Percutaneous dilational tracheostomy (PDT) is a common and increasingly used procedure in the intensive care unit (ICU). It is usually performed with bronchoscopy guidance. Ultrasound has emerged as a useful tool in order to assist PDT, potentially improving its success rate and reducing procedural-related complications. OBJECTIVE: To investigate whether the ultrasound-guided PDT is equivalent or superior to the bronchoscopy-guided or anatomical landmarks-guided PDT with regard to procedural-related and clinical complications...
January 1, 2018: Journal of Intensive Care Medicine
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