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Phase 1 clinical trial

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https://www.readbyqxmd.com/read/28241153/effect-of-magnesium-oxide-supplementation-on-nocturnal-leg-cramps-a-randomized-clinical-trial
#1
Noga Roguin Maor, Mordechai Alperin, Elena Shturman, Hassan Khairaldeen, Moran Friedman, Khaled Karkabi, Uzi Milman
Importance: Magnesium supplements are widely marketed for prophylaxis of nocturnal leg cramps (NLC) despite no evidence of significant benefit. Objective: To determine whether magnesium oxide is better than placebo for NLC prophylaxis. Design, Setting, and Participants: A randomized, double-blind, placebo-controlled clinical trial of 2 weeks eligibility screening followed by 4 weeks of treatment was conducted in northern Israel, from February to October 2013...
February 20, 2017: JAMA Internal Medicine
https://www.readbyqxmd.com/read/28241133/measuring-fatigue-using-the-multidimensional-fatigue-inventory-20-a-questionable-factor-structure-in-haemodialysis-patients
#2
Joseph Chilcot, Ayman Guirguis, Karin Friedli, Michael Almond, Andrew Davenport, Clara Day, David Wellsted, Ken Farrington
BACKGROUND/AIMS: Fatigue is recognised as a common and burdensome symptom among dialysis patients. A growing body of research is devoted to understanding fatigue in advanced kidney disease, yet its measurement is challenging within this context. Our aim was to evaluate the factor structure underlying the multidimensional fatigue inventory (MFI-20) and to examine its associations with clinical factors and mood. METHODS: Data was evaluated for confirmatory factor analysis (CFA) from the screening phase of a multicentre randomised placebo-controlled trial of sertraline in haemodialysis (HD) patients...
February 28, 2017: Nephron
https://www.readbyqxmd.com/read/28240971/phase-i-trial-of-the-human-double-minute-2-inhibitor-mk-8242-in-patients-with-advanced-solid-tumors
#3
Andrew J Wagner, Udai Banerji, Amit Mahipal, Neeta Somaiah, Heather Hirsch, Craig Fancourt, Amy O Johnson-Levonas, Raymond Lam, Amy K Meister, Giuseppe Russo, Clayton D Knox, Shelonitda Rose, David S Hong
Purpose To evaluate MK-8242 in patients with wild-type TP53 advanced solid tumors. Patients and Methods MK-8242 was administered orally twice a day on days 1 to 7 in 21-day cycles. The recommended phase II dose (RP2D) was determined on the basis of safety, tolerability, pharmacokinetics (PK), and by mRNA expression of the p53 target gene pleckstrin homology-like domain, family A, member 3 ( PHLDA3). Other objectives were to characterize the PK/pharmacodynamic (PD) relationship, correlate biomarkers with response, and assess tumor response...
February 27, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28240968/systematic-literature-review-and-network-meta-analysis-of-treatment-outcomes-in-relapsed-and-or-refractory-multiple-myeloma
#4
Chrissy H Y van Beurden-Tan, Margreet G Franken, Hedwig M Blommestein, Carin A Uyl-de Groot, Pieter Sonneveld
Purpose Since 2000, many new treatment options have become available for relapsed and/or refractory multiple myeloma (R/R MM) after a long period in which dexamethasone and melphalan had been the standard treatment. Direct comparisons of these novel treatments, however, are lacking. This makes it extremely difficult to evaluate the relative added value of each new treatment. Our aim was to synthesize all efficacy evidence, enabling a comparison of all current treatments for R/R MM. Methods We performed a systematic literature review to identify all publicly available phase III randomized controlled trial evidence...
February 27, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28240592/analysis-of-non-melanoma-skin-cancer-across-the-tofacitinib-rheumatoid-arthritis-clinical-programme
#5
Jeffrey R Curtis, Eun Bong Lee, George Martin, Xavier Mariette, Ketti K Terry, Yan Chen, Jamie Geier, John Andrews, Mandeep Kaur, Haiyun Fan, Chudy I Nduaka
OBJECTIVES: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We evaluated the incidence of non-melanoma skin cancer (NMSC) across the tofacitinib RA development programme. METHODS: NMSC events (through August 2013) were identified in patients receiving tofacitinib in two Phase (P)1, eight P2, six P3 and two long-term extension (LTE) studies. In P123 studies, tofacitinib was administered at various doses (1-30 mg twice daily [BID], 20 mg once daily), as monotherapy or with conventional synthetic disease-modifying anti-rheumatic drugs, mainly methotrexate...
February 27, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28239939/combining-the-gpr40-agonist-fasiglifam-with-sitagliptin-improves-glycemic-control-in-patients-with-type-2-diabetes-with-or-without-metformin-a-randomized-12-week-trial
#6
Xuejun V Peng, John F Marcinak, Marsha G Raanan, Charlie Cao
AIMS: To evaluate the efficacy and safety of fasiglifam, an orally active G protein-coupled receptor 40 agonist, in combination with the dipeptidyl peptidase-4 inhibitor sitagliptin, in patients with type 2 diabetes inadequately controlled with diet/exercise (± metformin). METHODS: In this randomized, double-blind, phase II study, 368 patients received once-daily placebo, sitagliptin 100 mg, fasiglifam 25 or 50 mg, or the combination of sitagliptin 100 mg plus fasiglifam 25 or 50 mg...
February 27, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28239472/analyses-of-the-peripheral-immunome-following-multiple-administrations-of-avelumab-a-human-igg1-anti-pd-l1-monoclonal-antibody
#7
Renee N Donahue, Lauren M Lepone, Italia Grenga, Caroline Jochems, Massimo Fantini, Ravi A Madan, Christopher R Heery, James L Gulley, Jeffrey Schlom
BACKGROUND: Multiple anti-PD-L1/PD-1 checkpoint monoclonal antibodies (MAb) have shown clear evidence of clinical benefit. All except one have been designed or engineered to omit the possibility to mediate antibody-dependent cell-mediated cytotoxicity (ADCC) as a second potential mode of anti-tumor activity; the reason for this is the concern of lysis of PD-L1 positive immune cells. Avelumab is a fully human IgG1 MAb which has been shown in prior in vitro studies to mediate ADCC versus a range of human tumor cells, and clinical studies have demonstrated anti-tumor activity versus a range of human cancers...
2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/28238789/the-significance-of-the-trial-outcome-was-associated-with-publication-rate-and-time-to-publication
#8
Seung Yeon Song, Dong-Hoe Koo, Sun-Young Jung, Won Ku Kang, Eun Young Kim
OBJECTIVE: This study aims to comprehensively assess the publication of clinical trial results and factors associated with their publication. STUDY DESIGN AND SETTING: Phase II and phase III trials of advanced breast cancer registered on ClinicalTrials.gov between October 1, 2000, and September 30, 2012 were identified. Publications were searched by using PubMed and reviewing those listed on the registry site. The main outcomes were publication rate, public availability of results, and time to publication...
February 24, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28238601/safety-immunogenicity-and-preliminary-clinical-efficacy-of-a-vaccine-against-extraintestinal-pathogenic-escherichia-coli-in-women-with-a-history-of-recurrent-urinary-tract-infection-a-randomised-single-blind-placebo-controlled-phase-1b-trial
#9
Angela Huttner, Christoph Hatz, Germie van den Dobbelsteen, Darren Abbanat, Alena Hornacek, Rahel Frölich, Anita M Dreyer, Patricia Martin, Todd Davies, Kellen Fae, Ingrid van den Nieuwenhof, Stefan Thoelen, Serge de Vallière, Anette Kuhn, Enos Bernasconi, Volker Viereck, Tilemachos Kavvadias, Kerstin Kling, Gloria Ryu, Tanja Hülder, Sabine Gröger, David Scheiner, Cristina Alaimo, Stephan Harbarth, Jan Poolman, Veronica Gambillara Fonck
BACKGROUND: Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V). METHODS: In this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo...
February 23, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28238492/progesterone-luteal-support-after-ovulation-induction-and-intrauterine-insemination-an-updated-systematic-review-and-meta-analysis
#10
Katherine A Green, Jessica R Zolton, Sophia M V Schermerhorn, Terrence D Lewis, Mae W Healy, Nancy Terry, Alan H DeCherney, Micah J Hill
OBJECTIVE: To evaluate the effect of progesterone (P) for luteal phase support after ovulation induction (OI) and intrauterine insemination (IUI). DESIGN: An updated systematic review and meta-analysis. SETTING: Not applicable. PATIENT(S): Patients undergoing OI-IUI for infertility. INTERVENTION(S): Exogenous P luteal support after OI-IUI. MAIN OUTCOME MEASURE(S): Live birth...
February 23, 2017: Fertility and Sterility
https://www.readbyqxmd.com/read/28238190/effects-of-6%C3%A2-months-of-resveratrol-versus-placebo-on-pentraxin-3-in-patients-with-type-2-diabetes-mellitus-a-double-blind-randomized-controlled-trial
#11
S Bo, V Ponzo, A Evangelista, G Ciccone, I Goitre, F Saba, M Procopio, M Cassader, R Gambino
AIMS: The anti-inflammatory effects of the polyphenol resveratrol in patients with type 2 diabetes mellitus (T2DM) are controversial. Its role on pentraxin 3 (PTX3) concentrations, a human acute phase protein, has never been evaluated. Our aim was to determine whether a two-dosage resveratrol supplementation (500 and 40 mg/day) has an impact on PTX3 values in T2DM patients from a double-blind randomized placebo-controlled trial. Variations in total antioxidant status (TAS) were evaluated too...
February 25, 2017: Acta Diabetologica
https://www.readbyqxmd.com/read/28238187/circulating-tumor-cells-clinical-validity-and-utility
#12
REVIEW
Luc Cabel, Charlotte Proudhon, Hugo Gortais, Delphine Loirat, Florence Coussy, Jean-Yves Pierga, François-Clément Bidard
Circulating tumor cells (CTCs) are rare tumor cells and have been investigated as diagnostic, prognostic and predictive biomarkers in many types of cancer. Although CTCs are not currently used in clinical practice, CTC studies have accumulated a high level of clinical validity, especially in breast, lung, prostate and colorectal cancers. In this review, we present an overview of the current clinical validity of CTCs in metastatic and non-metastatic disease, and the main concepts and studies investigating the clinical utility of CTCs...
February 25, 2017: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28237867/exploratory-analysis-of-biomarkers-associated-with-clinical-outcomes-from-the-study-of-lenvatinib-in-differentiated-cancer-of-the-thyroid
#13
Makoto Tahara, Martin Schlumberger, Rossella Elisei, Mouhammed Amir Habra, Naomi Kiyota, Ralf Paschke, Corina E Dutcus, Taro Hihara, Shannon McGrath, Mark Matijevic, Tadashi Kadowaki, Yasuhiro Funahashi, Steven I Sherman
BACKGROUND: Lenvatinib significantly prolonged progression-free survival (PFS) versus placebo in the phase III Study of (E7080) LEnvatinib in differentiated Cancer of the Thyroid (SELECT) of patients with radioiodine-refractory differentiated thyroid cancer. This exploratory analysis investigated potential predictive biomarkers of lenvatinib efficacy and target engagement. PATIENTS AND METHODS: Circulating cytokine/angiogenic factors (CAFs) in blood samples collected at baseline and throughout treatment were analysed from patients randomised to receive lenvatinib or placebo from August 5, 2011 to October 4, 2012...
February 23, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28237426/the-role-of-the-human-visual-cortex-in-assessment-of-the-long-term-durability-of-retinal-gene-therapy-in-follow-on-rpe65-clinical-trial-patients
#14
Manzar Ashtari, Elena S Nikonova, Kathleen A Marshall, Gloria J Young, Puya Aravand, Wei Pan, Gui-Shuang Ying, Aimee E Willett, Mani Mahmoudian, Albert M Maguire, Jean Bennett
PURPOSE: Gene therapy (GT) has offered immense hope to individuals who are visually impaired because of RPE65 mutations. Although GT has shown great success in clinical trials enrolling these individuals, evidence for stability and durability of this treatment over time is still unknown. Herein we explored the value of functional magnetic resonance imaging (fMRI) as an objective measure to assess independently the longevity of retinal GT. DESIGN: Individuals with RPE65 mutations who underwent GT in their worse-seeing eye in a phase 1 clinical trial received a second subretinal injection in their contralateral eye in a follow-on clinical trial...
February 22, 2017: Ophthalmology
https://www.readbyqxmd.com/read/28236698/impact-of-seizure-frequency-reduction-on-health-related-quality-of-life-among-clinical-trial-subjects-with-refractory-partial-onset-seizures-a-pooled-analysis-of-phase-iii-clinical-trials-of-eslicarbazepine-acetate
#15
Fulton F Velez, T Christopher Bond, Kathryn P Anastassopoulos, Xuezhe Wang, Rui Sousa, David Blum, Joyce A Cramer
BACKGROUND: Subjects who received eslicarbazepine acetate (ESL) as adjunctive therapy experienced significantly greater seizure frequency reduction (SFR) than placebo in three phase III, randomized, double-blind trials. This analysis compared changes in health-related quality of life (HRQOL) between treatment responders and non-responders across the pooled, per-protocol population (N=842) using the validated Quality of Life in Epilepsy Inventory-31 (QOLIE-31). METHODS: QOLIE-31 scores were calculated for Total Score (TS) and seven subscales; higher scores indicate better HRQOL...
February 22, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28236697/budget-impact-of-perampanel-as-adjunctive-treatment-of-uncontrolled-partial-onset-and-primary-generalized-tonic-clonic-seizures-in-the-united-states
#16
Gabriel Tremblay, Victoria Barghout, Vardhaman Patel, Wan Tsong, Zhixiao Wang
PURPOSE: To evaluate the budget impact (BI) of adopting perampanel for adjunctive treatment of partial-onset seizures (POS), with or without secondarily generalized seizures, and the adjunctive treatment of primary generalized tonic-clonic seizures (PGTCS) in patients 12years or older in the United States. METHODS: A BI model was developed to estimate the potential BI of adopting adjunctive perampanel from a US payer (direct costs only) and societal (direct and indirect costs) perspective over a 5-year period...
February 17, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28235848/patients-with-long-qt-syndrome-due-to-impaired-herg-encoded-kv11-1-potassium-channel-have-exaggerated-endocrine-pancreatic-and-incretin-function-associated-with-reactive-hypoglycemia
#17
Louise Hyltén-Cavallius, Eva W Iepsen, Nicolai J Wewer Albrechtsen, Mathilde Svendstrup, Anniek F Lubberding, Bolette Hartmann, Thomas Jespersen, Allan Linneberg, Michael Christiansen, Henrik Vestergaard, Oluf Pedersen, Jens J Holst, Jørgen K Kanters, Torben Hansen, Signe S Torekov
Background -Loss-of-function mutations in hERG (encoding the Kv11.1 voltage-gated potassium channel) cause long QT syndrome (LQT2) due to prolonged cardiac repolarization. However, Kv11.1 is also present in pancreatic α and β cells and intestinal L and K cells, secreting glucagon, insulin, and the incretins glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), respectively. These hormones are crucial for glucose regulation and LQTS may cause disturbed glucose regulation. We measured secretion of these hormones and cardiac repolarization in response to glucose ingestion in LQT2 patients with functional mutations in hERG and matched healthy participants, testing the hypothesis that LQT2 patients have increased incretin and β cell- and decreased α cell function and thus lower glucose levels...
February 24, 2017: Circulation
https://www.readbyqxmd.com/read/28235817/intracerebral-hemorrhage-location-and-outcome-among-interact2-participants
#18
Candice Delcourt, Shoichiro Sato, Shihong Zhang, Else Charlotte Sandset, Danni Zheng, Xiaoying Chen, Maree L Hackett, Hisatomi Arima, Jun Hata, Emma Heeley, Rustam Al-Shahi Salman, Thompson Robinson, Leo Davies, Pablo M Lavados, Richard I Lindley, Christian Stapf, John Chalmers, Craig S Anderson
OBJECTIVE: To clarify associations between intracerebral hemorrhage (ICH) location and clinical outcomes among participants of the main phase Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2). METHODS: Associations between ICH sites and poor outcomes (death [6] or major disability [3-5] of modified Rankin Scale) and European Quality of Life Scale (EQ-5D) utility scores at 90 days were assessed in logistic regression models. RESULTS: Of 2,066 patients included in the analyses, associations were identified between ICH sites and poor outcomes: involvement of posterior limb of internal capsule increased risks of death or major disability (odds ratio [OR] 2...
February 24, 2017: Neurology
https://www.readbyqxmd.com/read/28231045/original-research-paper-public-health-care-system-a-quasi-experimental-study-acceptance-and-attitude-to-implicate-clinical-services
#19
Syed Wasif Gillani, Mohi Iqbal Mohammad Abdul
A six-month longitudinal intervention arm study with a pre-post cross-sectional questionnaire-based survey was performed. A 3-phase objective structured clinical examination (OSCE) design was utilized for evaluation of acceptance and attitude of pharmacy students towards clinical pharmacy services. The pre-OSCE survey showed increased disagreement with the role of clinical pharmacists, compared to a significant positive shift in attitude towards their services in the healthcare team after 6 months of the trial...
March 1, 2017: Acta Pharmaceutica
https://www.readbyqxmd.com/read/28230252/randomized-double-blind-placebo-controlled-phase-2-study-of-ganaxolone-as-add-on-therapy-in-adults-with-uncontrolled-partial-onset-seizures
#20
Michael R Sperling, Pavel Klein, Julia Tsai
OBJECTIVE: To evaluate the efficacy and safety of ganaxolone as adjunctive therapy in adults with uncontrolled partial-onset seizures despite taking up to three concomitant antiepileptic drugs (AEDs). METHODS: Adults aged 18-69 years and refractory to conventional AEDs were enrolled in a multicenter, double-blind, placebo-controlled trial. After an 8-week baseline period, patients were randomized 2:1 to ganaxolone 1,500 mg/day or placebo for a 10-week treatment period (2-week forced titration and 8-week maintenance) followed by either tapering or entry into an open-label extension study...
February 23, 2017: Epilepsia
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