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randomized controlled trial toxicity

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https://www.readbyqxmd.com/read/28538284/the-advance-study-a-groundbreaking-trial-to-evaluate-a-candidate-universal-antiretroviral-regimen
#1
Willem D F Venter, Polly Clayden, Celicia Serenata
PURPOSE OF REVIEW: Current WHO-recommended first-line therapy in low-income and middle-income countries has been very successful in saving millions of lives but still has toxicity concerns and a low barrier to resistance. RECENT FINDINGS: Two candidate antiretrovirals may substantially transform first-line therapy in low-income and middle-income countries, yielding a safer, more robust and cheaper regimen. Tenofovir alafenamide carries toxicity and cost benefits over tenofovir disoproxil fumarate...
May 19, 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/28529748/local-modulated-electro-hyperthermia-in-combination-with-traditional-chinese-medicine-vs-intraperitoneal-chemoinfusion-for-the-treatment-of-peritoneal-carcinomatosis-with-malignant-ascites-a-phase-ii-randomized-trial
#2
Clifford L K Pang, Xinting Zhang, Zhen Wang, Junwen Ou, Yimin Lu, Pengfei Chen, Changlin Zhao, Xiaopu Wang, Hongyu Zhang, Sergey V Roussakow
The purpose of this study was to develop a safe and non-toxic alternative to the conventional conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) by investigating the efficacy and safety of local modulated electro-hyperthermia (mEHT) combined with the traditional Chinese medicine (TCM) 'Shi Pi' herbal decoction, compared with standard intraperitoneal chemoinfusion (IPCI). A randomized, controlled, single-center, open-label clinical trial (phase II) with two parallel groups (allocation ratio, 1:1) was conducted to investigate the efficacy and safety of mEHT+TCM (study group, SG) vs...
May 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28515936/pulse-dose-steroids-in-severe-pulmonary-arterial-hypertension-secondary-to-systemic-lupus-erythematosus
#3
Cody Lee, Jean Elwing
OBJECTIVE: The pulmonary vascular targeted treatment for systemic lupus erythematosus-associated pulmonary arterial hypertension is similar to other connective tissue disease-associated pulmonary arterial hypertension. In addition, there also appears to be a role for immunosuppression in the overall management. However, the optimal immunosuppressive regimen and what patients will respond to treatments are currently not clearly elucidated given the lack of randomized controlled trials on the subject...
2017: SAGE open medical case reports
https://www.readbyqxmd.com/read/28514302/safety-and-efficacy-evaluation-of-pertuzumab-in-patients-with-solid-tumors
#4
Chenjing Zhu, Wenwu Ling, Jing Zhang, Hui Gao, Kai Shen, Xuelei Ma
BACKGROUND: The development of targeted therapies benefits patients with certain markers in the treatment of breast cancer. Pertuzumab is a novel humanized monoclonal antibody that blocks human epidermal growth factor receptor 2 (HER2) dimerization. The Food and Drug Administration has approved pertuzumab in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer. METHODS: To assess the safety and efficacy profile of pertuzumab, we searched PubMed and Embase (articles from January 1966 to January 2015) using the keyword "pertuzumab"...
May 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28501853/efficacy-and-safety-of-long-term-therapy-for-high-grade-glioma-with-temozolomide-a-meta-analysis
#5
Weilin Xu, Tao Li, Liansheng Gao, Jingwei Zheng, Anwen Shao, Jianmin Zhang
Further treatments are warranted in preventing recurrence or progression for high-grade glioma (HGG) patients having achieved stable disease with tolerable toxicity after the Stupp regimen (6 cycles of temozolomide). This meta-analysis aims to extensively evaluate the safety, feasibility, and efficacy of long-term therapy with temozolomide (> 6cycles) for these patients. We systematically searched the pubmed, Embase and Chinese Biomedical (CBM) databases using the strategy of combination of free-text words and MeSH terms...
April 24, 2017: Oncotarget
https://www.readbyqxmd.com/read/28491864/can-getting-enough-vitamin-d-during-pregnancy-reduce-the-risk-of-getting-asthma-in-childhood
#6
REVIEW
Evangelia Bountouvi, Konstantinos Douros, Anna Papadopoulou
The worldwide increase in asthma prevalence during the last decades and the re-emergence of vitamin D deficiency in many populations hinted toward an underlying association between these two conditions. Since asthma is presented with high incidence in childhood and neonatal vitamin D stores depend on maternal vitamin levels, a possible programming effect of maternal vitamin D status during gestation was suggested. Observational and longitudinal studies on this subject led to inconclusive results with glimmer of positivity...
2017: Frontiers in Pediatrics
https://www.readbyqxmd.com/read/28490356/transhepatic-arterial-infusion-chemotherapy-using-a-combination-of-miriplatin-and-cddp-powder-versus-miriplatin-alone-in-the-treatment-of-hepatocellular-carcinoma-a-randomized-controlled-trial
#7
Kenya Kamimura, Takeshi Suda, Takeshi Yokoo, Hiroteru Kamimura, Tsutomu Kanefuji, Atsunori Tsuchiya, Masaaki Takamura, Hirokazu Kawai, Nobuo Waguri, Satoshi Yamagiwa, Shuji Terai
BACKGROUND: Based on promising results from a Phase I study of hepatic arterial infusion chemotherapy using a combination of miriplatin and cisplatin powder (DDP-H) for unresectable hepatocellular carcinoma (UMIN-CTR000003541), a multicenter, open-label, randomized phase II study was conducted to evaluate the efficacy and safety of the combination therapy versus miriplatin monotherapy. METHODS: Nineteen patients, five and fourteen Barcelona-Clinic Liver Cancer staging classification A and B cases, respectively, were randomly assigned to receive either miriplatin monotherapy (n = 9) or miriplatin/DDP-H combination therapy (n = 10)...
May 10, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28488142/a-prospective-randomized-controlled-trial-of-hydrating-nail-solution-for-prevention-or-treatment-of-onycholysis-in-breast-cancer-patients-who-received-neoadjuvant-adjuvant-docetaxel-chemotherapy
#8
Ji-Yeon Kim, Oh Nam Ok, Jeong-Ju Seo, Soo-Hyeon Lee, Jin Seok Ahn, Young-Hyuck Im, Yeon Hee Park
PURPOSE: Onycholysis and other nail toxicities occur in approximately 20-30% of breast cancer (BC) patients receiving docetaxel chemotherapy. Onycholysis is often associated with painful paronychia, decreasing patients' quality of life. In this study, we aimed to evaluate the efficacy of hydrating nail solution (HNS) (EVONAIL(®) solution, Evaux Laboratories, France) for the prevention and treatment of docetaxel-induced onycholysis and nail toxicities. METHODS: This study was a prospective, randomized, controlled study of HNS for the prevention or treatment of onycholysis in patients with docetaxel after doxorubicin plus cyclophosphamide...
May 9, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28485320/aerosolized-amikacin-as-adjunctive-therapy-of-ventilator-associated-pneumonia-caused-by-multidrug-resistant-gram-negative-bacteria-a-single-center-randomized-controlled-trial
#9
Chang Liu, Yu-Ting Zhang, Zhi-Yong Peng, Qing Zhou, Bo Hu, Hui Zhou, Jian-Guo Li
BACKGROUND: Aerosolized amikacin (AA) is a current option for the management of ventilator-associated pneumonia (VAP) caused by multidrug-resistant Gram-negative bacteria (MDR-GNB), as it is reported that AA could increase the alveolar level of the drug without increasing systemic toxicity. This study aimed to evaluate the efficacy and safety of AA as an adjunctive therapy for VAP caused by MDR-GNB. METHODS: In this single-center, double-blind study conducted in a 36-bed general Intensive Care Unit (ICU) in a tertiary hospital from June 2014 to June 2016, 52 ICU patients with confirmed MDR-GNB VAP were randomized to two groups (AA group, n = 27 and placebo group, n = 25)...
May 20, 2017: Chinese Medical Journal
https://www.readbyqxmd.com/read/28480841/neoadjuvant-%C3%B0-hemotherapy-for-locally-advanced-breast-cancer
#10
Y Fomenko, V Sirota, I Omarova, N Kabildina, A Amanov
93 patients with LABC (T2N1-2M0, T3N0-2M0) at the age from 35 to 75 years were included in the trial. With 2 stage - 60 patients, with the third stage - 33 patients. All patients were randomized into 3 groups: The I control group (n=36) received 4 courses of neoadjuvant chemotherapy according to AC-protocol (doxorubicin 50 mg/m2, cyclophosphan-500 mg/m2 on day 1, repeated every three weeks) followed by radical mastectomy, 4 courses of adjuvant chemotherapy (АС), radiotherapy and hormone therapy if indicated...
March 2017: Georgian Medical News
https://www.readbyqxmd.com/read/28479233/addition-of-gemcitabine-to-paclitaxel-epirubicin-and-cyclophosphamide-adjuvant-chemotherapy-for-women-with-early-stage-breast-cancer-tango-final-10-year-follow-up-of-an-open-label-randomised-phase-3-trial
#11
Helena M Earl, Louise Hiller, Helen C Howard, Janet A Dunn, Jennie Young, Sarah J Bowden, Michelle McDermaid, Anna K Waterhouse, Gregory Wilson, Rajiv Agrawal, Susan O'Reilly, Angela Bowman, Diana M Ritchie, Andrew Goodman, Tamas Hickish, Karen McAdam, David Cameron, David Dodwell, Daniel W Rea, Carlos Caldas, Elena Provenzano, Jean E Abraham, Peter Canney, John P Crown, M John Kennedy, Robert Coleman, Robert C Leonard, James A Carmichael, Andrew M Wardley, Christopher J Poole
BACKGROUND: The tAnGo trial was designed to investigate the potential role of gemcitabine when added to anthracycline and taxane-containing adjuvant chemotherapy for early breast cancer. When this study was developed, gemcitabine had shown significant activity in metastatic breast cancer, and there was evidence of a favourable interaction with paclitaxel. METHODS: tAnGo was an international, open-label, randomised, phase 3 superiority trial that enrolled women aged 18 years or older with newly diagnosed, early-stage breast cancer who had a definite indication for chemotherapy, any nodal status, any hormone receptor status, Eastern Cooperative Oncology Group performance status of 0-1, and adequate bone marrow, hepatic, and renal function...
May 4, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28474588/comparative-efficacy-and-safety-of-caffeine-and-aminophylline-for-apnea-of-prematurity-in-preterm-%C3%A2-34-weeks-neonates-a-randomized-controlled-trial
#12
M Shivakumar, P Jayashree, Muhammad Najih, Leslie Edward Simon Lewis, Ramesh Bhat Y, Asha Kamath, - Shashikala
OBJECTIVE: To compare the efficacy and safety of standard doses of Caffeine and Aminophylline for Apnea of prematurity. STUDY DESIGN: Randomized controlled trial. SETTING: Tertiary-care referral centre and a teaching institution in Southern India. Trial was conducted from February 2012 to January 2015. PARTICIPANTS: 240 preterm (≤34 wk) neonates with apnea of prematurity. INTERVENTIONS: Neonates randomized into two groups: Caffeine group received loading dose of caffeine citrate (20 mg/kg) followed by 5 mg/kg/day maintenance dose every 24 hour...
April 15, 2017: Indian Pediatrics
https://www.readbyqxmd.com/read/28463827/taurolidine-citrate-lock-therapy-for-primary-prevention-of-catheter-related-infections-in-cancer-patients-results-of-a-prospective-randomized-phase-iv-trial-atapac
#13
Raffaele Longo, Mathieu Llorens, Christophe Goetz, Christian Platini, Nada Eid, Jocelyne Sellies, Nadia Ouamara, Philippe Quétin
BACKGROUND: Totally implantable venous access port (TIVAP)-related infections (RIs) remain a serious health problem in cancer patients receiving an intravenous (i.v.) therapy. PATIENTS AND METHODS: The ATAPAC study was a prospective, randomized, monocentric, phase IV trial evaluating the efficacy of taurolidine lock solution versus standard saline solution for primary TIVAP-RI prevention in nonhematological cancer patients receiving i.v. chemotherapy. The primary endpoint was the TIVAP-RI incidence rate...
May 3, 2017: Oncology
https://www.readbyqxmd.com/read/28463460/contrast-induced-acute-kidney-injury-following-peripheral-angiography-with-carbon-dioxide-versus-iodinated-contrast-media-a-meta-analysis-and-systematic-review-of-current-literature
#14
Saad S Ghumman, Jonathan Weinerman, Aazib Khan, Mubeen S Cheema, Marlene Garcia, Daniel Levin, Rajeev Suri, Anand Prasad
OBJECTIVE: We conducted a meta-analysis to compare the incidence of acute kidney injury (AKI) with carbon dioxide (CO2 ) versus iodinated contrast media (ICM). BACKGROUND: Contrast induced-acute kidney injury (CI-AKI) is a known complication following endovascular procedures with ICM. CO2 has been employed as an alternative imaging medium as it is nontoxic to the kidneys. METHODS: Search of indexed databases was performed and 1,732 references were retrieved...
May 2, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28463012/comparison-of-palbociclib-in-combination-with-letrozole-or-fulvestrant-with-endocrine-therapies-for-advanced-metastatic-breast-cancer-network-meta-analysis
#15
Costel Chirila, Debanjali Mitra, Ann Colosia, Caroline Ling, Dawn Odom, Shrividya Iyer, James A Kaye
BACKGROUND: Palbociclib is the first cyclin-dependent kinase 4/6 inhibitor approved in the United States for HR+/HER2- advanced/metastatic breast cancer, in combination with letrozole as initial endocrine-based therapy in postmenopausal women or with fulvestrant in women with disease progression following endocrine therapy. We compared progression-free survival (PFS) and discontinuations due to adverse events for palbociclib combinations against other endocrine therapies using a mixed-treatment comparison meta-analysis of randomized, controlled trials...
May 16, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28459606/hypofractionated-postmastectomy-radiation-therapy-is-safe-and-effective-first-results-from-a-prospective-phase-ii-trial
#16
Atif J Khan, Matthew M Poppe, Sharad Goyal, Kristine E Kokeny, Thomas Kearney, Laurie Kirstein, Deborah Toppmeyer, Dirk F Moore, Chunxia Chen, David K Gaffney, Bruce G Haffty
Purpose Conventionally fractionated postmastectomy radiation therapy (PMRT) takes approximately 5 to 6 weeks. Data supporting hypofractionated PMRT is limited. We prospectively evaluated a short course of hypofractionated PMRT, in which therapy was completed in 15 treatment days. Patients and Methods We delivered PMRT at a dose of 36.63 Gy in 11 fractions of 3.33 Gy over 11 days to the chest wall and the draining regional lymph nodes, followed by an optional mastectomy scar boost of four fractions of 3.33 Gy...
May 1, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28456089/the-30-year-experience-a-meta-analysis-of-randomised-and-high-quality-non-randomised-studies-of-hyperthermic-intraperitoneal-chemotherapy%C3%A2-in-the-treatment-of-gastric-cancer
#17
REVIEW
Jacopo Desiderio, Joseph Chao, Laleh Melstrom, Susanne Warner, Federico Tozzi, Yuman Fong, Amilcare Parisi, Yanghee Woo
IMPORTANCE: Hyperthermic intraperitoneal chemotherapy (HIPEC) has been used within various multimodality strategies for the prevention and treatment of gastric cancer peritoneal carcinomatosis. OBJECTIVE: To systematically evaluate the role of HIPEC in gastric cancer and clarify its effectiveness at different stages of peritoneal disease progression. DATA SOURCES: Medline and Embase databases between January 1, 1985 and June 1, 2016. STUDY SELECTION: Randomised control trials and high-quality non-randomised control trials selected on a validated tool (methodological index for non-randomised studies) comparing HIPEC and standard oncological management for the treatment of advanced stage gastric cancer with and without peritoneal carcinomatosis were considered...
April 26, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28453702/a-phase-2-randomized-double-blind-placebo-%C3%A2-controlled-study-of-chemo-immunotherapy-combination-using-motolimod-with-pegylated-liposomal-doxorubicin-in-recurrent-or-persistent-ovarian-cancer-a-gynecologic-oncology-group-partners-study
#18
B J Monk, M F Brady, C Aghajanian, H A Lankes, T Rizack, J Leach, J M Fowler, R Higgins, P Hanjani, M Morgan, R Edwards, W Bradley, T Kolevska, P Foukas, E M Swisher, K S Anderson, R Gottardo, J K Bryan, M Newkirk, K L Manjarrez, R S Mannel, R M Hershberg, G Coukos
Background: A phase 2, randomized, placebo-controlled trial was conducted in women with recurrent epithelial ovarian carcinoma to evaluate the efficacy and safety of motolimod-a Toll-like receptor 8 (TLR8) agonist that stimulates robust innate immune responses-combined with pegylated liposomal doxorubicin (PLD), a chemotherapeutic that induces immunogenic cell death. Patients and methods: Women with ovarian, fallopian tube, or primary peritoneal carcinoma were randomized 1 : 1 to receive PLD in combination with blinded motolimod or placebo...
May 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28446297/-prophylaxis-of-bortezomib-induced-peripheral-neuropathy-in-patients-with-multiple-myeloma-by-high-dose-intravenous-mecobalamin
#19
Li-Li Zhang, Yi-Hao Wang, Zong-Hong Shao, Jun Ma
OBJECTIVE: To evaluate the efficacy and safety of high-dose intravenous mecobalamin (HDIME) for the treatment of bortezomib-induced peripheral neuropathy(BIPN) in the patients with multiple myeloma (MM). METHODS: A total of 65 newly diagonsed patients with multiple myeloma receiving bortezomib in Tianjin Medical University General Hospital were enrolled in this single-centre randomized clinical trial from July 2012 to May 2016. Out of 65 patients 38 in control group received bortezomib-based chemotherapy and 27 patients in HDIME group received the additional high-dose intravenous mecobalamin...
April 2017: Zhongguo Shi Yan Xue Ye Xue za Zhi
https://www.readbyqxmd.com/read/28444488/prophylactic-swallow-therapy-for-patients-with-head-and-neck-cancer-undergoing-chemoradiotherapy-a-randomized-trial
#20
Barbara Pisano Messing, Elizabeth C Ward, Cathy L Lazarus, Melissa Kim, Xian Zhou, Jessica Silinonte, Dorothy Gold, Karen Harrer, Karen Ulmer, Samantha Merritt, Geoffrey Neuner, Marshall Levine, Ray Blanco, John Saunders, Joseph Califano
Evidence supporting prophylactic swallow exercises for patients with head and neck cancer (HNC) has not been universally demonstrated. This RCT examined diet level, feeding tube use, swallow function, and quality of life (QOL) of patients undergoing chemoradiotherapy who performed prophylactic swallowing exercises. Sixty HNC patients were randomized into exercise versus control groups. Swallowing, oromotor, toxicity, and QOL data were recorded (baseline, 3, 6, 12, 24 months). Physiological swallow function was examined at baseline and 3 months...
April 25, 2017: Dysphagia
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