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https://www.readbyqxmd.com/read/28334974/efficacy-and-safety-of-sequential-use-of-everolimus-in-japanese-patients-with-advanced-renal-cell-carcinoma-after-failure-of-first-line-treatment-with-vascular-endothelial-growth-factor-receptor-tyrosine-kinase-inhibitor-a-multicenter-phase-ii-clinical-trial
#1
Masafumi Oyama, Takayuki Sugiyama, Masahiro Nozawa, Kiyohide Fujimoto, Takeshi Kishida, Go Kimura, Noriaki Tokuda, Shiro Hinotsu, Kojiro Shimozuma, Hideyuki Akaza, Seiichiro Ozono
Objective: Many studies have shown the efficacy of everolimus after pretreatment with vascular endothelial growth factor receptor-tyrosine kinase inhibitors. We investigated the efficacy and safety of everolimus as a second-line treatment after the failure of vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy in Japanese patients with advanced renal cell carcinoma. Methods: This was an open-label, multicenter, phase II trial conducted in Japan through the central registration system...
March 1, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28334771/efficacy-and-safety-of-a-3-month-dosing-regimen-of-degarelix-in-japanese-patients-with-prostate-cancer-a-phase-ii-maintenance-dose-finding-study
#2
Seiichiro Ozono, Taiji Tsukamoto, Seiji Naito, Yasuo Ohashi, Takeshi Ueda, Tsutomu Nishiyama, Hideki Maeda, Hidehito Kusuoka, Rio Akazawa, Mototsugu Ito, Hideyuki Akaza
Objective: To evaluate the efficacy and safety of degarelix 3-month depot in Japanese patients with prostate cancer. Methods: In this Phase II, open-label, parallel-group study, 155 Japanese prostate cancer patients were randomized to treatment with degarelix administered subcutaneously at a maintenance dose of 360 or 480 mg every 84 days for 12 months, after receiving an initial dose of 240 mg. The primary endpoint was the cumulative probability of serum testosterone ≤0...
February 18, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28334495/elbasvir-grazoprevir-does-not-worsen-renal-function-in-patients-with-hepatitis-c-virus-infection-and-pre-existing-renal-disease
#3
K Rajender Reddy, David Roth, Annette Bruchfeld, Peggy Hwang, Barbara Haber, Michael N Robertson, Eliav Barr, Wayne Greaves
AIM: Treatment options have been limited for patients with hepatitis C virus (HCV) infection and chronic kidney disease stage 4/5 (CKD 4/5). The aim of this analysis was to evaluate the impact of elbasvir/grazoprevir on estimated glomerular filtration rate (eGFR) in patients with CKD stage 3 enrolled in phase II/III clinical trials. METHODS: We conducted a retrospective integrated analysis of patients with CKD 3 enrolled in the EBR/GZR phase II/III clinical trials...
March 23, 2017: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/28334439/a-phase-2-trial-of-dasatinib-in-patients-with-locally-advanced-or-stage-iv-mucosal-acral-or-vulvovaginal-melanoma-a-trial-of-the-ecog-acrin-cancer-research-group-e2607
#4
Kevin Kalinsky, Sandra Lee, Krista M Rubin, Donald P Lawrence, Anthony J Iafrarte, Darell R Borger, Kim A Margolin, Mario M Leitao, Ahmad A Tarhini, Henry B Koon, Andrew L Pecora, Anthony J Jaslowski, Gary I Cohen, Timothy M Kuzel, Christopher D Lao, John M Kirkwood
BACKGROUND: KIT-directed tyrosine kinase inhibitors such as imatinib have demonstrated benefits in KIT-mutant (KIT+) mucosal, acral, vulvovaginal, and chronically sun-damaged (CSD) melanoma. Dasatinib has superior preclinical activity in comparison with other tyrosine kinase inhibitors against cells with the most common KIT mutation, exon 11(L576P) . The ECOG-ACRIN E2607 trial assessed dasatinib in patients with these melanoma subtypes. METHODS: Patients received 70 mg of oral dasatinib twice daily...
March 23, 2017: Cancer
https://www.readbyqxmd.com/read/28333318/a-phase-iii-randomized-controlled-trial-comparing-the-efficacy-safety-and-tolerability-of-oral-dydrogesterone-versus-micronized-vaginal-progesterone-for-luteal-support-in-in-vitro-fertilization
#5
Herman Tournaye, Gennady T Sukhikh, Elke Kahler, Georg Griesinger
STUDY QUESTION: Is oral dydrogesterone 30 mg daily (10 mg three times daily [TID]) non-inferior to micronized vaginal progesterone (MVP) 600 mg daily (200 mg TID) for luteal support in in vitro fertilization (IVF), assessed by the presence of fetal heartbeats determined by transvaginal ultrasound at 12 weeks of gestation? SUMMARY ANSWER: Non-inferiority of oral dydrogesterone versus MVP was demonstrated at 12 weeks of gestation, with a difference in pregnancy rate and an associated confidence interval (CI) that were both within the non-inferiority margin...
March 1, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28333221/surgical-treatment-of-adhesion-related-chronic-abdominal-and-pelvic-pain-after-gynaecological-and-general-surgery-a-systematic-review-and-meta-analysis
#6
Barend A van den Beukel, Roy de Ree, Suzanne van Leuven, Erica A Bakkum, Chema Strik, Harry van Goor, Richard P G Ten Broek
BACKGROUND: Chronic pain is a frequent post-operative complication, affecting ~20-40% of patients who have undergone surgery of the female genital or alimentary tract. Chronic pain is an important risk factor for diminished quality of life after surgery. Adhesions are frequently associated with chronic post-operative pain; however, surgical treatment of adhesion-related pain is controversial. OBJECTIVE AND RATIONALE: The aim of this study was to investigate the efficacy and harms of surgical interventions for chronic post-operative pain attributable to adhesions...
March 2, 2017: Human Reproduction Update
https://www.readbyqxmd.com/read/28333086/the-effect-of-a-breakfast-rich-in-slowly-digestible-starch-on-glucose-metabolism-a-statistical-meta-analysis-of-randomized-controlled-trials
#7
REVIEW
Sophie Vinoy, Alexandra Meynier, Aurélie Goux, Nathalie Jourdan-Salloum, Sylvie Normand, Rémi Rabasa-Lhoret, Olivier Brack, Julie-Anne Nazare, François Péronnet, Martine Laville
Starch digestibility may have an effect on the postprandial blood glucose profile. The aim of this meta-analysis was to analyze the relationship between Slowly Digestible Starch (SDS) levels and plasma glucose appearance and disappearance rates, as well as other parameters of glucose metabolism, after healthy subjects consumed cereal products that differed in SDS content. Three randomized controlled clinical trials that included a total of 79 subjects were identified. Using binary classification for the variables (high versus low levels, more than 12 g of SDS per portion, and less than 1 g of SDS per portion, respectively), we found that there was a 15-fold higher chance of having a low rate of appearance of exogenous glucose (RaE) after consumption of a high-SDS product...
March 23, 2017: Nutrients
https://www.readbyqxmd.com/read/28332144/efficacy-and-safety-of-ideglira-in-participants-with-type-2-diabetes-in-india-uncontrolled-on-oral-antidiabetic-drugs-and-basal-insulin-data-from-the-dual-clinical-trial-program
#8
Kamlesh Khunti, Viswanathan Mohan, Sunil M Jain, Trine Welløv Boesgaard, Kamilla Begtrup, Bipin Sethi
INTRODUCTION: The efficacy and safety of insulin degludec/liraglutide (IDegLira) has been evaluated in the Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes (DUAL) phase 3 clinical trial program. In this post hoc analysis, we compared the efficacy and safety of IDegLira in the Indian subpopulation with the results from the global trial population of DUAL trials. The analysis includes participants uncontrolled on oral antidiabetic drugs (OADs) in DUAL I and DUAL IV and participants uncontrolled on basal insulin and OADs in DUAL II...
March 22, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28331557/adapalene-benzoyl-peroxide-gel-is-efficacious-and-safe-in-adult-female-acne-with-a-profile-comparable-to-that-seen-in-teen-aged-females
#9
Linda Stein Gold, Hilary Baldwin, Maria Jose Rueda, Nabil Kerrouche, Brigitte DrÉno
Objectives: To evaluate the efficacy and safety of adapalene 0.1% benzoyl peroxide 2.5% gel in women aged 25 years or older via subgroup analysis of existing Phase 2 and 3 study data. Methods: Meta-analysis of pooled data from three multicenter, randomized, double-blind, vehicle-controlled, parallel-group, clinical trials compared results of treatment with either adapalene 0.1% benzoyl peroxide 2.5% gel or vehicle gel in adult females and teen-aged females. Efficacy assessments included investigator's global assessment and median percent change in acne lesions...
July 2016: Journal of Clinical and Aesthetic Dermatology
https://www.readbyqxmd.com/read/28331539/randomized-placebo-controlled-phase-iv-pilot-study-of-ramosetron-to-evaluate-the-co-primary-end-points-in-male-patients-with-irritable-bowel-syndrome-with-diarrhea
#10
Motoko Ida, Akito Nishida, Hiraku Akiho, Yoshihiro Nakashima, Kei Matsueda, Shin Fukudo
BACKGROUND: Global assessment allows patients to assess improvement in multiple irritable bowel syndrome (IBS) symptoms. However, it was deemed important to assess "clinically meaningful improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" in addition to global assessment to show how ramosetron is effective for individual IBS symptoms. This is a pilot study to explore clinical endpoints focusing on the chief complaint of patients with IBS with diarrhea (IBS-D)...
2017: BioPsychoSocial Medicine
https://www.readbyqxmd.com/read/28331050/first-in-human-clinical-trial-of-oral-onc201-in-patients-with-refractory-solid-tumors
#11
Mark N Stein, Joseph R Bertino, Howard L Kaufman, Tina Mayer, Rebecca Moss, Ann Silk, Nancy Chan, Jyoti Malhotra, Lorna Rodriguez-Rodriguez, Joseph Aisner, Robert D Aiken, Bruce G Haffty, Robert S DiPaola, Tracie Saunders, Andrew Zloza, Sherri Damare, Yasmeen Beckett, Bangning Yu, Saltanat Najmi, Christian Gabel, Siobhan Dickerson, Ling Zheng, Wafik S El-Deiry, Joshua Allen, Martin Stogniew, Wolfgang Oster, Janice M Mehnert
Purpose ONC201 is a small molecule selective antagonist of the G protein-coupled receptor DRD2 that is the founding member of the imipridone class of compounds. A first-in-human phase I study of ONC201 was conducted to determine its recommended phase II dose (RP2D). Experimental Design This open-label study treated 10 patients during dose escalation with histologically-confirmed advanced solid tumors. Patients received ONC201 orally once every 3 weeks, defined as one cycle, at doses from 125 to 625 mg using an accelerated titration design...
March 22, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28329432/user-compliance-with-documenting-on-a-track-and-trigger-based-observation-and-response-chart-a-two-phase-multi-site-audit-study
#12
Doug Elliott, Emily Allen, Sharon McKinley, Lin Perry, Christine Duffield, Margaret Fry, Robyn Gallagher, Rick Iedema, Michael Roche
AIMS: To examine user compliance and completeness of documentation with a newly designed Observation and Response Chart and whether a rapid response system call was triggered when clinically indicated. BACKGROUND: Timely recognition and responses to patient deterioration in hospital general wards remains a challenge for health care systems globally. Evaluating practice initiatives to improve recognition and response are required. DESIGN: Two-phase audit...
March 22, 2017: Journal of Advanced Nursing
https://www.readbyqxmd.com/read/28329053/sofosbuvir-plus-ribavirin-without-interferon-for-treatment-of-acute-hepatitis-c-virus-infection-in-hiv-1-infected-individuals-swift-c
#13
Susanna Naggie, Kristen M Marks, Michael Hughes, Daniel S Fierer, Christine Macbrayne, Arthur Kim, Kimberly Hollabaugh, Jhoanna Roa, Bill Symonds, Diana M Brainard, John G McHutchison, Marion G Peters, Jennifer J Kiser, Raymond Chung
Background.: Historically, acute hepatitis C virus (HCV) infection was treated with shorter durations of interferon-containing therapies. In the era of direct-acting antivirals (DAAs), it is unclear whether the efficacy of treatment achieved in chronic infection can be maintained with abbreviated courses of therapy during the acute phase. Methods.: The sofosbuvir-containing regimens without interferon for treatment of acute HCV in HIV-1 infected individuals (SWIFT-C) is an open-label, 2-cohort clinical trial in which the first cohort assessed for the safety and efficacy of 12 weeks of sofosbuvir plus ribavirin for the treatment of acute HCV infection in participants with chronic human immunodeficiency virus type 1 (HIV-1) infection...
February 27, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28327944/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
#14
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 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...
February 21, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28327923/heart-dose-exposure-as-prognostic-marker-after-radiotherapy-for-resectable-stage-iiia-b-non-small-cell-lung-cancer-secondary-analysis-of-a-randomised-trial
#15
M Guberina, W Eberhardt, M Stuschke, T Gauler, F Heinzelmann, D Cheufou, M Kimmich, G Friedel, H Schmidberger, K Darwiche, V Jendrossek, M Schuler, G Stamatis, C Pöttgen
BACKGROUND: Heart exposure to ionizing irradiation can cause ischemic heart disease. The partial heart volume receiving ≥5 Gy (heartV5) was supposed to be an independent prognostic factor for survival after radiochemotherapy for locally advanced non-small cell lung cancer (NSCLC). But validation of the latter hypothesis is needed under the concurrent risks of lung cancer patients. PATIENTS AND METHODS: The ESPATUE phase III trial recruited patients with potentially operable IIIA(N2)/selected IIIB NSCLC between 01/2004 and 01/2013...
February 21, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28327893/bcl2-expression-but-not-myc-and-bcl2-coexpression-predicts-survival-in-elderly-patients-with-diffuse-large-b-cell-lymphoma-independently-of-cell-of-origin-in-the-phase-3-lnh03-6b-trial
#16
T Petrella, C Copie-Bergman, J Brière, R Delarue, F Jardin, P Ruminy, C Thieblemont, M Figeac, D Canioni, P Feugier, B Fabiani, K Leroy, M Parrens, M André, C Haioun, G A Salles, P Gaulard, H Tilly, J P Jais, T J Molina
Background: Our aim was to evaluate whether the cell of origin (COO) as defined by the Hans algorithm and MYC/BCL2 coexpression, which are the two main biological risk factors in elderly patients treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisolone (R-CHOP), maintain their prognostic value in a large prospective clinical trial. Patients and Methods: We evaluated 285 paraffin-embedded samples from patients (60-80 years of age) enrolled in the Lymphoma Study Association (LYSA) trial LNH03-6B who were treated with R-CHOP...
January 24, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28327140/efficacy-and-safety-of-canagliflozin-in-patients-with-type-2-diabetes-based-on-history-of-cardiovascular-disease-or-cardiovascular-risk-factors-a-post-hoc-analysis-of-pooled-data
#17
Michael J Davies, Katherine Merton, Ujjwala Vijapurkar, Jacqueline Yee, Rong Qiu
BACKGROUND: Treatment of patients with type 2 diabetes mellitus (T2DM) and a history of cardiovascular (CV) disease or CV risk factors may present clinical challenges due to the presence of comorbid conditions and the use of concomitant medications. The sodium glucose co-transporter 2 inhibitor, canagliflozin, has been shown to improve glycaemic control and reduce body weight and blood pressure (BP) with a favourable tolerability profile in a broad range of patients with T2DM. This post hoc analysis assessed the efficacy and safety of canagliflozin in patients with T2DM based on CV disease history or CV risk factors...
March 21, 2017: Cardiovascular Diabetology
https://www.readbyqxmd.com/read/28327089/uniform-fdg-pet-guided-gradient-dose-prescription-to-reduce-late-radiation-toxicity-upgrade-rt-study-protocol-for-a-randomized-clinical-trial-with-dose-reduction-to-the-elective-neck-in-head-and-neck-squamous-cell-carcinoma
#18
Sven van den Bosch, Tim Dijkema, Martina C Kunze-Busch, Chris H J Terhaard, Cornelis P J Raaijmakers, Patricia A H Doornaert, Frank J P Hoebers, Marije R Vergeer, Bas Kreike, Oda B Wijers, Wim J G Oyen, Johannes H A M Kaanders
BACKGROUND: In definitive radiation therapy for head and neck cancer, clinically uninvolved cervical lymph nodes are irradiated with a so-called 'elective dose' in order to achieve control of clinically occult metastases. As a consequence of high-resolution diagnostic imaging, occult tumor volume has significantly decreased in the last decades. Since the elective dose is dependent on occult tumor volume, the currently used elective dose may be higher than necessary. Because bilateral irradiation of the neck contributes to dysphagia, xerostomia and hypothyroidism in a dose dependent way, dose de-escalation to these regions can open a window of opportunity to reduce toxicity and improve quality of life after treatment...
March 21, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28327055/the-evaluation-of-the-anti-cancer-activity-of-ixazomib-on-caco2-colon-solid-tumor-cells-comparison-with-bortezomib
#19
Selin Engür, Miriş Dikmen
Proteasome inhibition has recently emerged as a clinically effective anticancer therapeutic approach. The first proteasome inhibitor, bortezomib (Velcade, PS-341), and new proteasome inhibitors including ixazomib have become more important in the development of targeted cancer therapies. Under physiological conditions, MLN9708 (ixazomib citrate), the stable citrate ester drug substance, hydrolyzes rapidly to MLN2238 (ixazomib), the biologically active boronic acid. It is a second-generation proteasome inhibitor, similar to the well-known proteasome inhibitor bortezomib, which is currently being investigated in phase 3 trials as a treatment for multiple Myeloma...
March 22, 2017: Acta Clinica Belgica
https://www.readbyqxmd.com/read/28326906/a-practical-guide-to-the-sublingual-immunotherapy-tablet-adverse-event-profile-implications-for-clinical-practice
#20
David I Bernstein, Jose A Bardelas, Bodil Svanholm Fogh, Amarjot Kaur, Ziliang Li, Hendrik Nolte
OBJECTIVES: Treatment with allergy immunotherapy improves allergic rhinoconjunctivitis, but can also improve comorbidities associated with allergic rhinitis such as asthma. Sublingual immunotherapy (SLIT)-tablets are a convenient and efficacious method of allergy immunotherapy. They are self-administered after the first tablet has been provided under medical supervision. Therapy may elicit local reactions or, rarely, systemic allergic reactions. The objective of this report is to inform healthcare practitioners about the safety and tolerability profile of SLIT-tablets and use this information to provide practical guidance that may inform patients regarding potential adverse reactions and how to manage them...
March 22, 2017: Postgraduate Medicine
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