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Randomized clinical trials

Rudolph M Navari
The approach to the treatment of nausea and vomiting in a cancer patient should begin with a complete assessment, including the frequency, duration, and intensity of the nausea/vomiting; associated activities; and whether anorexia or cachexia is present. It is important to determine whether the nausea and vomiting is related to treatment (chemotherapy, radiation) or is independent of cancer treatment. Nausea/vomiting unrelated to chemotherapy and/or radiation may have an etiology for which there is a specific and potentially successful intervention...
March 15, 2018: Oncology (Williston Park, NY)
Douglas P Beall, M R Chambers, Sam Thomas, John Amburgy, James R Webb, Bradly S Goodman, Devin K Datta, Richard W Easton, Douglas Linville, Sanjay Talati, John B Tillman
BACKGROUND: Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful, threatening quality of life and increasing risk of morbidity and mortality. Balloon kyphoplasty is a percutaneous option for treating painful cancer- and osteoporosis-related VCFs, supported by 2 randomized trials demonstrating efficacy benefits of BKP over nonsurgical care. OBJECTIVE: To investigate 12-mo disability, quality of life, and safety outcomes specifically in a Medicare-eligible population, representing characteristic patients seen in routine clinical practice...
March 14, 2018: Neurosurgery
Annet Wijnen, Sjoukje E Bouma, Gesine H Seeber, Lucas H V van der Woude, Sjoerd K Bulstra, Djordje Lazovic, Martin Stevens, Inge van den Akker-Scheek
OBJECTIVE: To assess the therapeutic validity and effectiveness of physiotherapeutic exercise interventions following total hip arthroplasty (THA) for osteoarthritis. DATA SOURCES: The databases Embase, MEDLINE, Cochrane Library, CINAHL and AMED were searched from inception up to February 2017. ELIGIBILITY CRITERIA: Articles reporting results of randomized controlled trials in which physiotherapeutic exercise was compared with usual care or with a different type of physiotherapeutic exercise were included, with the applied interventions starting within six months after THA...
2018: PloS One
Sherine Ismail, Mohamed Osman, Rayf Abulezz, Hani Alhamdan, K H Mujtaba Quadri
Pharmacists possess pivotal competencies and expertise in developing clinical pathways (CPs). We present a tertiary care facility experience of pharmacists vis-a-vis interprofessional collaboration for designing and implementing CPs. We participated in the development of CPs as leading members of a collaborative team of healthcare professionals. We reviewed literature, aligning it with hospital formulary and institutional standards, and participated in weekly team meetings for six months. Several tools and services were adapted to guide prescribing and standardization of care through time-bound order sets...
March 16, 2018: Pharmacy (Basel, Switzerland)
Hannah R Wardill, Ysabella Z A Van Sebille, Matthew A Ciorba, Joanne M Bowen
PURPOSE OF REVIEW: Strong preclinical data support prophylactic probiotics as an effective preventive strategy for diarrhoea secondary to anticancer therapies. To determine the composite evidence that this approach translates to the clinic, we performed a meta-analysis of randomized controlled trials (RCTs) of prophylactic probiotics for the prevention of cancer therapy induced diarrhoea. RECENT FINDINGS: A three-step search strategy was used to identify relevant studies (1 June 2000-1 June 2017) investigating probiotic intervention for diarrhoea secondary to any cancer therapy (cytotoxic, targeted and immunotherapies)...
March 14, 2018: Current Opinion in Supportive and Palliative Care
Neil E O'Connell, Louise Marston, Sally Spencer, Lorraine H DeSouza, Benedict M Wand
BACKGROUND: This is an updated version of the original Cochrane Review published in 2010, Issue 9, and last updated in 2014, Issue 4. Non-invasive brain stimulation techniques aim to induce an electrical stimulation of the brain in an attempt to reduce chronic pain by directly altering brain activity. They include repetitive transcranial magnetic stimulation (rTMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), transcranial random noise stimulation (tRNS) and reduced impedance non-invasive cortical electrostimulation (RINCE)...
March 16, 2018: Cochrane Database of Systematic Reviews
Da Li, Yu-Ming Jiao, Liang Wang, Fu-Xin Lin, Jun Wu, Xian-Zeng Tong, Shuo Wang, Yong Cao
OBJECTIVE Surgical management of brainstem lesions is challenging due to the highly compact, eloquent anatomy of the brainstem. This study aimed to evaluate the safety and efficacy of preoperative diffusion tensor imaging (DTI) and diffusion tensor tractography (DTT) in brainstem cavernous malformations (CMs). METHODS A prospective randomized controlled clinical trial was performed by using stratified blocked randomization. The primary eligibility criterion of the study was being a surgical candidate for brainstem CMs (with informed consent)...
March 16, 2018: Journal of Neurosurgery
George Grunberger, Yehuda Handelsman, Zachary T Bloomgarden, Vivian A Fonseca, Alan J Garber, Richard A Haas, Victor L Roberts, Guillermo E Umpierrez
This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there are no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician...
March 2018: Endocrine Practice
Ana Carolina Ribeiro Ferreira, Ana Cláudia Pereira Guida, Adriana Arruda Piccini, Júlia Risso Parisi, Ligia de Sousa
OBJECTIVE: To assess the effects of galvano-puncture (GG) and dermabrasion (DG) in reducing striae distensae in the gluteal region of women. METHODS: This randomized, controlled, single-blind clinical trial was conducted at the UNIFAL-MG. Participants were 48 female who had striae distensae alba in the gluteal region. They were randomly divided in GG; DG; and Control Group (CG). The length and width of the largest striae were measured (in millimeters) using a caliper...
March 16, 2018: Journal of Cosmetic and Laser Therapy: Official Publication of the European Society for Laser Dermatology
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
Igor Filipčić, Ivona Šimunović Filipčić, Tomislav Gajšak, Željko Milovac, Strahimir Sučić, Ena Ivezić, Sandra Zečević Penić, Ivana Orgulan, Damir Šebo, Vjekoslav Jeleč, Žarko Bajić
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique with few side effects that has been reported to be effective in the treatment of major depressive disorder (MDD). At present, no randomized controlled trials (RCT) have compared the efficacy and safety of rTMS delivered by the figure-8-coil and the H1-coil. We describe an industry-independent, randomized, controlled, single-blinded, single-center study protocol assessing the differences in efficacy and safety of rTMS for patients diagnosed with MDD with the H1-coil and figure-8-coil as an add-on to stable pharmacotherapy or pharmacotherapy alone...
March 2018: Psychiatria Danubina
Ruchita Dixit, Sowmya Nettem, Simerjit S Madan, Htoo Htoo Kyaw Soe, Adinegara Bl Abas, Leah D Vance, Patrick J Stover
BACKGROUND: Sickle cell disease (SCD) is a group of disorders that affects haemoglobin, which causes distorted sickle- or crescent-shaped red blood cells. It is characterized by anaemia, increased susceptibility to infections and episodes of pain. The disease is acquired by inheriting abnormal genes from both parents, the combination giving rise to different forms of the disease. Due to increased erythropoiesis in people with SCD, it is hypothesized that they are at an increased risk for folate deficiency...
March 16, 2018: Cochrane Database of Systematic Reviews
A Kornuijt, D Das, T Sijbesma, L de Vries, W van der Weegen
INTRODUCTION: The etiology of the stiff knee after total knee arthroplasty (TKA) is largely unknown, although excessive scar tissue due to arthrofibrosis is an important reason for a limited range of motion (ROM) after this procedure. Persistent limited ROM after TKA results in poor patient-reported outcomes and is increasingly becoming a more prominent reason for TKA revision surgery. METHODS: A narrative review of current literature on manipulation under anesthesia (MUA) after TKA analyzing etiology and risk factors for stiffness after TKA, effectiveness of MUA and what is known about rehabilitation after MUA...
March 15, 2018: Musculoskeletal Surgery
Judd B Kessler, Andrea B Troxel, David A Asch, Shivan J Mehta, Noora Marcus, Raymond Lim, Jingsan Zhu, William Shrank, Troyen Brennan, Kevin G Volpp
BACKGROUND: Poor medication adherence is common and limits the effectiveness of treatment. OBJECTIVE: To investigate how social supports, automated alerts, and their combination improve medication adherence. DESIGN: Four-arm, randomized clinical trial with a 6-month intervention. PARTICIPANTS: A total of 179 CVS health employees or adult dependents with CVS Caremark prescription coverage, a current daily statin prescription, a medication possession ratio less than 80%, and Internet access...
March 15, 2018: Journal of General Internal Medicine
X Serra-Aracil, A Zárate, L Mora, S Serra-Pla, A Pallisera, J Bonfill, J Bargalló, A Pando, S Delgado, E Balleteros, C Pericay
PURPOSE: Compared with the open approach, laparoscopic total mesorectal excision (TME) achieves faster patient recovery, reduces morbidity rates, and shortens hospital stay. However, in laparoscopic low anterior resection (L-LAR), conversion to open surgery is required in almost 20% of cases. Transanal TME (Ta-TME) combined with laparoscopy, also called hybrid natural orifice transluminal endoscopic surgery (NOTES), is a less invasive procedure that can overcome some of the limitations of laparoscopic rectal surgery...
March 16, 2018: International Journal of Colorectal Disease
Juan Li, Xiaozhe Li, Xiuzhen Tong, Junru Liu, Beihui Huang, Meilan Chen, Lifen Kuang, Zhenhai Zhou, Duorong Xu
PURPOSE: This randomized, open-label trial was conducted to investigate the optimal duration of bed rest after intrathecal chemotherapy to reduce the incidence of complications without increasing patients' tolerance to long-term bed rest. METHODS: A total of 390 patients receiving intrathecal chemotherapy were randomly assigned 1:1:1 to undergo bed rest for 6, 8, or 10 h after intrathecal chemotherapy. The primary outcome was the rate of complications after intrathecal chemotherapy...
March 15, 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Salvatore Grisanti, Deborah Cosentini, Valeria Tovazzi, Susanna Bianchi, Barbara Lazzari, Francesca Consoli, Elisa Roca, Alfredo Berruti, Vittorio D Ferrari
PURPOSE: Trabectedin is one of the few active agents in soft tissue sarcoma (STS) but hepatotoxicity is frequent and represents a dose-limiting factor. Protective strategies aiming at counteracting this important side effect have a crucial clinical impact. Due to its antioxidant properties, N-acetylcysteine (NAC) has a recognized hepatoprotective effect and this provides the rationale for testing NAC in the management of trabectedin-induced hepatotoxicity. METHODS: Patients with recurrent or metastatic soft tissue sarcoma, consecutively observed at our institution, who were considered eligible to trabectedin, received concomitant NAC if they had impaired hepatic or renal function at baseline or developed hepatotoxicity during treatment...
March 15, 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Kasper Meidahl Petersen, Søren Bøgevig, Jens Juul Holst, Filip Krag Knop, Mikkel Bring Christensen
Context: Glucagon's effects on hemodynamic parameters - most notably heart rate and cardiac contractility - are overlooked. The glucagon receptor is a central target in novel and anticipated type 2 diabetes therapies and hemodynamic consequences of glucagon signaling have therefore become increasingly important. In this review we summarize and evaluate published studies on glucagon pharmacology with focus on clinical hemodynamic effects in humans. Evidence acquisition: PubMed, EMBASE and the Cochrane library were searched for clinical studies concerning hemodynamic effects of glucagon (no year restriction)...
March 13, 2018: Journal of Clinical Endocrinology and Metabolism
Lanlin Yang, Sufen Cai, Shuoping Zhang, Xiangyi Kong, Yifan Gu, Changfu Lu, Jing Dai, Fei Gong, Guangxiu Lu, Ge Lin
STUDY QUESTION: Does single cleavage-stage (Day 3) embryo transfer using a time-lapse (TL) hierarchical classification model achieve comparable ongoing pregnancy rates (OPR) to single blastocyst (Day 5) transfer by conventional morphological (CM) selection? SUMMARY ANSWER: Day 3 single embryo transfer (SET) with a hierarchical classification model had a significantly lower OPR compared with Day 5 SET with CM selection. WHAT IS KNOWN ALREADY: Cleavage-stage SET is an alternative to blastocyst SET...
March 13, 2018: Human Reproduction
Gary R Zirpoli, Susan E McCann, Lara E Sucheston-Campbell, Dawn L Hershman, Gregory Ciupak, Warren Davis, Joseph M Unger, Halle C F Moore, James A Stewart, Claudine Isaacs, Timothy J Hobday, Muhammad Salim, Gabriel N Hortobagyi, Julie R Gralow, G Thomas Budd, Kathy S Albain, Christine B Ambrosone
Background: Chemotherapy-induced peripheral neuropathy (CIPN) can interfere with daily function and quality of life, and there are no known preventive approaches. In a cohort of breast cancer patients receiving paclitaxel as part of a clinical trial (SWOG 0221), we examined the use of dietary supplements both before diagnosis and during treatment in relation to CIPN. Methods: At registration to S0221, 1225 breast cancer patients completed questionnaires regarding the use of multivitamins and supplements before and at diagnosis...
December 1, 2017: Journal of the National Cancer Institute
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