keyword
MENU ▼
Read by QxMD icon Read
search

Phase 1 clinical trial

keyword
https://www.readbyqxmd.com/read/29786420/bacteria-driven-hypoxia-targeting-for-combined-biotherapy-and-photothermal-therapy
#1
Wenfei Chen, Ying Wang, Ming Qin, Xudong Zhang, Zhirong Zhang, Xun Sun, Zhen Gu
The facultative anaerobe Salmonella strain VNP20009 selectively colonizes into tumors following systemic injection due to its preference for the hypoxia in the tumor cores. However, the Phase 1 Clinical Trial of VNP20009 has been terminated mainly due to its weak anti-tumor effects and exhibition of dose-dependent toxicity. Here we leveraged the advantages of VNP20009 biotherapy together with polydopamine-mediated photothermal therapy in order to enhance the antitumor efficacy toward malignant melanoma. VNP20009 was coated with polydopamine via oxidation and self-polymerization, which was then injected into tumor-bearing mice via the tail vein...
May 22, 2018: ACS Nano
https://www.readbyqxmd.com/read/29786128/long-term-oncologic-outcomes-of-laparoscopic-sentinel-node-navigation-surgery-in-early-gastric-cancer-a-single-center-single-arm-phase-ii-trial
#2
Do Joong Park, Young Suk Park, Sang Yong Son, Ju-Hee Lee, Hye Seung Lee, Young Soo Park, Kyoung Ho Lee, Young Hoon Kim, Kyoung Un Park, Won Woo Lee, Soyeon Ahn, Sang-Hoon Ahn, Hyung-Ho Kim
BACKGROUND: Sentinel node navigation surgery (SNNS) in early gastric cancer (EGC) is technically feasible according to previous literature, however its long-term oncologic safety has not been reported. METHODS: A single-center, single-arm, phase II trial was conducted to determine the oncologic outcomes of laparoscopic sentinel node (SN) biopsy in clinical stage T1N0M0 gastric cancer patients. Cases with positive SNs on intraoperative pathologic examination underwent conventional gastrectomy with radical lymphadenectomy (SN-positive group), whereas those with negative SNs underwent laparoendoscopic-limited gastric resections without further lymph node dissections (SN-negative group)...
May 21, 2018: Annals of Surgical Oncology
https://www.readbyqxmd.com/read/29785709/four-year-follow-up-of-a-single-arm-phase-ii-clinical-trial-of-ibrutinib-with-rituximab-ir-in-patients-with-relapsed-refractory-mantle-cell-lymphoma-mcl
#3
Preetesh Jain, Jorge Romaguera, Samer A Srour, Hun J Lee, Frederick Hagemeister, Jason Westin, Luis Fayad, Felipe Samaniego, Maria Badillo, Liang Zhang, Lorreta Nastoupil, Rashmi Kanagal-Shamanna, Nathan Fowler, Michael L Wang
Ibrutinib has shown significant activity in patients with relapsed or refractory mantle cell lymphoma (RR-MCL). We report the long-term outcome and safety profile of a single-centre, single arm, open-label, phase 2 study of RR-MCL treated with IR. Overall, the median follow-up time was 47 months (range 1-52 months), median duration on treatment was 16 months (range 1-53 months) and median number of treatment cycles was 17 (range 1-56). Twenty-nine patients (58%) achieved complete remission and of these, 12 patients continue on study...
May 22, 2018: British Journal of Haematology
https://www.readbyqxmd.com/read/29785577/atezolizumab-a-review-in-previously-treated-advanced-non-small-cell-lung-cancer
#4
REVIEW
Hannah A Blair
Atezolizumab (TECENTRIQ™), an immune checkpoint inhibitor, is an immunoglobulin G1 monoclonal antibody that binds to programmed death ligand 1 (PD-L1) and blocks its interactions with programmed death 1 and B7.1 receptors. Atezolizumab is approved as monotherapy in several countries worldwide for the treatment of patients with advanced non-small cell lung cancer (NSCLC) who have previously received chemotherapy. Approval was based on its clinical benefit in this setting in the phase II POPLAR and phase III OAK trials...
May 21, 2018: Targeted Oncology
https://www.readbyqxmd.com/read/29785570/phase-1b-investigation-of-the-mek-inhibitor-binimetinib-in-patients-with-advanced-or-metastatic-biliary-tract-cancer
#5
R S Finn, D H Ahn, M M Javle, B R Tan, C D Weekes, J C Bendell, A Patnaik, G N Khan, D Laheru, R Chavira, J Christy-Bittel, E Barrett, M B Sawyer, Tanios S Bekaii-Saab
Background The MAPK pathway plays a central role in regulation of several cellular processes, and its dysregulation is a hallmark of biliary tract cancer (BTC). Binimetinib (MEK162), a potent, selective oral MEK1/2 inhibitor, was assessed in patients with advanced BTC. Patients and Methods An expansion cohort study in patients who received ≤1 line of therapy for advanced BTC was conducted after determination of the maximum tolerated dose in this Phase 1 trial. Patients received binimetinib 60 mg twice daily...
May 22, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29785265/a-randomized-controlled-trial-of-the-safety-and-efficacy-of-a-topical-gentamicin-collagen-sponge-in-diabetic-patients-with-a-mild-foot-ulcer-infection
#6
Ilker Uçkay, Benjamin Kressmann, Sébastien Di Tommaso, Marina Portela, Heba Alwan, Hubert Vuagnat, Sophie Maître, Christophe Paoli, Benjamin A Lipsky
Objectives: The initial phase of infection of a foot ulcer in a person with diabetes is often categorized as mild. Clinicians usually treat these infections with antimicrobial therapy, often applied topically. Some experts, however, believe that mild diabetic foot ulcer infections will usually heal with local wound care alone, without antimicrobial therapy or dressings. Methods: To evaluate the potential benefit of treatment with a topical antibiotic, we performed a single-center, investigator-blinded pilot study, randomizing (1:1) adult patients with a mild diabetic foot ulcer infection to treatment with a gentamicin-collagen sponge with local care versus local care alone...
2018: SAGE Open Medicine
https://www.readbyqxmd.com/read/29785237/early-onset-of-clinical-improvement-with-ixekizumab-in-a-randomized-open-label-study-of-patients-with-moderate-to-severe-plaque-psoriasis
#7
Saakshi Khattri, Orin Goldblum, Kathleen Solotkin, Yasmin Amir, Michelle S Min, Terri Ridenour, Fan Emily Yang, Mark Lebwohl
Objective: The purpose of this study was to evaluate the speed of onset of clinical response to ixekizumab (IXE) and assess the progression of visible improvement in patients with moderate-to-severe plaque psoriasis. Design: This was an interventional, randomized, open-label, Phase IIIb clinical trial. Setting: This was a single center study at the Mount Sinai School of Medicine. Participants: Twelve patients were randomized at a ratio of 1:1 to receive 80mg of ixekizumab every two (IXE Q2W) or four (IXE Q4W) weeks following a starting dose of 160mg of ixekizumab...
May 2018: Journal of Clinical and Aesthetic Dermatology
https://www.readbyqxmd.com/read/29783988/tolerogenic-bone-marrow-derived-dendritic-cells-induce-neuroprotective-regulatory-t-cells-in-a-model-of-parkinson-s-disease
#8
Charles R Schutt, Howard E Gendelman, R Lee Mosley
BACKGROUND: Administration of granulocyte-macrophage colony-stimulating factor (GM-CSF) increases regulatory T cell (Treg) number and function with control of neuroinflammation and neuronal protection in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) model of Parkinson's disease (PD). Recently, we demonstrated in an early phase 1 clinical trial that GM-CSF also improves motor skills in PD patients. However, the mechanisms of Treg induction and its effects on neuroprotective responses remain unknown...
May 21, 2018: Molecular Neurodegeneration
https://www.readbyqxmd.com/read/29783928/physical-activity-intervention-for-elderly-patients-with-reduced-physical-performance-after-acute-coronary-syndrome-hulk-study-rationale-and-design-of-a-randomized-clinical-trial
#9
Elisabetta Tonet, Elisa Maietti, Giorgio Chiaranda, Francesco Vitali, Matteo Serenelli, Giulia Bugani, Gianni Mazzoni, Rossella Ruggiero, Jonathan Myers, Giovanni Quinto Villani, Ursula Corvi, Giovanni Pasanisi, Simone Biscaglia, Rita Pavasini, Giulia Ricci Lucchi, Gianluigi Sella, Roberto Ferrari, Stefano Volpato, Gianluca Campo, Giovanni Grazzi
BACKGROUND: Reduced physical performance and impaired mobility are common in elderly patients after acute coronary syndrome (ACS) and they represent independent risk factors for disability, morbidity, hospital readmission and mortality. Regular physical exercise represents a means for improving functional capacity. Nevertheless, its clinical benefit has been less investigated in elderly patients in the early phase after ACS. The HULK trial aims to investigate the clinical benefit of an early, tailored low-cost physical activity intervention in comparison to standard of care in elderly ACS patients with reduced physical performance...
May 21, 2018: BMC Cardiovascular Disorders
https://www.readbyqxmd.com/read/29783863/phase-1-randomized-parallel-group-double-blind-placebo-controlled-trial-to-evaluate-the-effects-of-erenumab-amg-334-and-concomitant-sumatriptan-on-blood-pressure-in-healthy-volunteers
#10
Jan de Hoon, Anne Van Hecken, Corinne Vandermeulen, Marissa Herbots, Yumi Kubo, Ed Lee, Osa Eisele, Gabriel Vargas, Kristin Gabriel
Objectives The aim of this study was to assess the effects of concomitant administration of erenumab and sumatriptan on resting blood pressure, pharmacokinetics, safety, and tolerability in healthy subjects. Methods In this phase 1, parallel-group, one-way crossover, double-blind, placebo-controlled study, healthy adult subjects were randomized (1:2) to receive either intravenous placebo and subcutaneous sumatriptan 12 mg (i.e. two 6-mg injections separated by 1 hour) or intravenous erenumab 140 mg and subcutaneous sumatriptan 12 mg...
January 1, 2018: Cephalalgia: An International Journal of Headache
https://www.readbyqxmd.com/read/29783024/a-pooled-analysis-of-the-phase-3-revive-trials-randomized-double-blind-studies-to-evaluate-the-safety-and-efficacy-of-iclaprim-versus-vancomycin-for-treatment-of-acute-bacterial-skin-and-skin-structure-infections
#11
David B Huang, G Ralph Corey, Thomas L Holland, Thomas Lodise, William O'Riordan, Mark H Wilcox, Thomas M File, Matthew Dryden, Barbara Balser, Eve Desplats, Antoni Torres
BACKGROUND: Iclaprim, a diaminopyrimidine antibiotic, was compared with vancomycin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs) in two studies (REVIVE-1 and REVIVE-2). OBJECTIVES: We explored the efficacy and tolerability of iclaprim in a pooled analysis of results from both studies. METHODS: REVIVE-1 and REVIVE-2 were Phase 3, double-blind, randomized (1:1), multicenter, active-controlled, non-inferiority (margin of 10%) trials, each designed to enroll 600 patients a piece with ABSSSI...
May 18, 2018: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/29782182/a-specifically-designed-multispecies-probiotic-supplement-relieves-seasonal-allergic-rhinitis-symptoms
#12
Annabelle M Watts, Amanda J Cox, Peter K Smith, Isolde Besseling-van der Vaart, Allan W Cripps, Nicholas P West
BACKGROUND: Probiotics are purported to reduce symptoms of allergic rhinitis. This study sought to determine the proportion of participants with an improvement in the mini Rhinoconjunctivitis Quality of Life Questionnaire (mRQLQ) in response to a multispecies probiotic supplement with a Simon Two-Stage design. METHODS: This study was based on a Simon Two-Stage Design for p1 -p0  = 0.18 to account for seasonal variation in symptoms. Under this design, ≥10 patients are required to exhibit an improvement in quality-of-life scores to determine that there was sufficient activity for the supplement to be considered effective...
May 21, 2018: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
https://www.readbyqxmd.com/read/29782049/use-of-most-bothersome-symptom-as-a-coprimary-endpoint-in-migraine-clinical-trials-a-post-hoc-analysis-of-the-pivotal-zotrip-randomized-controlled-trial
#13
David W Dodick, Stewart J Tepper, Deborah I Friedman, Amy A Gelfand, Donald J Kellerman, Peter C Schmidt
OBJECTIVE: To better understand the utility of using pain freedom and most bothersome headache-associated symptom (MBS) freedom as co-primary endpoints in clinical trials of acute migraine interventions. BACKGROUND: Adhesive dermally applied microarray (ADAM) is an investigational system for intracutaneous drug administration. The recently completed pivotal Phase 2b/3 study (ZOTRIP), evaluating ADAM zolmitriptan for the treatment of acute moderate to severe migraine, was one of the first large studies to incorporate MBS freedom and pain freedom as co-primary endpoints per recently issued guidance by the US Food and Drug Administration...
May 21, 2018: Headache
https://www.readbyqxmd.com/read/29781471/translational-research-unit-development-of-nursing-standards-and-practice-within-a-specialized-unit-for-participants-in-early-phase-clinical-trials
#14
Theresa Rudnitzki, Tina Curtis, Julie Griffie
BACKGROUND: A growing need exists to ensure safe and skilled oncology nursing care for an increasing number of patients enrolled in phases 1 and 1/2 clinical trials and to provide detailed adherence to protocol administration. This can be best accomplished in a dedicated area for patients in early phase clinical trials. OBJECTIVES: Nursing standards and practice within a newly established translational research unit at an academic medical center were developed. METHODS: A portion of an existing outpatient infusion room composed of 13 beds and a sub-waiting room with 2 chairs was designated for placement of patients enrolled in early phase clinical trials...
June 1, 2018: Clinical Journal of Oncology Nursing
https://www.readbyqxmd.com/read/29781359/rhabdoviruses-as-vaccine-platforms-for-infectious-disease-and-cancer
#15
Franz Zemp, Jahanara Rajwani, Douglas J Mahoney
The family Rhabdoviridae (RV) comprises a large, genetically diverse collection of single-stranded, negative sense RNA viruses from the order Mononegavirales. Several RV members are being developed as live-attenuated vaccine vectors for the prevention or treatment of infectious disease and cancer. These include the prototype recombinant Vesicular Stomatitis Virus (rVSV) and the more recently developed recombinant Maraba Virus, both species within the genus Vesiculoviridae. A relatively strong safety profile in humans, robust immunogenicity and genetic malleability are key features that make the RV family attractive vaccine platforms...
May 21, 2018: Biotechnology & Genetic Engineering Reviews
https://www.readbyqxmd.com/read/29780028/induced-endometrial-trauma-endometrial-scratch-in-the-mid-luteal-menstrual-cycle-phase-preceding-first-cycle-ivf-icsi-versus-usual-ivf-icsi-therapy-study-protocol-for-a-randomised-controlled-trial
#16
Clare Pye, Robin Chatters, Judith Cohen, Kate Brian, Ying C Cheong, Susan Laird, Lamiya Mohiyiddeen, Jonathan Skull, Stephen Walters, Tracey Young, Mostafa Metwally
INTRODUCTION: Endometrial trauma commonly known as endometrial scratch (ES) has been shown to improve pregnancy rates in women with a history of repeated implantation failure undergoing in vitro fertilisation (IVF), with or without intracytoplasmic sperm injection (ICSI). However, the procedure has not yet been fully explored in women having IVF/ICSI for the first time. This study aims to examine the effect of performing an ES in the mid-luteal phase prior to a first-time IVF/ICSI cycle on the chances of achieving a clinical pregnancy and live birth...
May 20, 2018: BMJ Open
https://www.readbyqxmd.com/read/29779976/the-discovery-and-preclinical-evaluation-of-bms-707035-a-potent-hiv-1-integrase-strand-transfer-inhibitor
#17
B Narasimhulu Naidu, Michael A Walker, Margaret E Sorenson, Yasutsugu Ueda, John D Matiskella, Timothy P Connolly, Ira B Dicker, Zeyu Lin, Sagarika Bollini, Brian J Terry, Helen Higley, Ming Zheng, Dawn D Parker, Dedong Wu, Stephen Adams, Mark R Krystal, Nicholas A Meanwell
BMS-707035 is an HIV-1 integrase strand transfer inhibitor (INSTI) discovered by systematic optimization of N-methylpyrimidinone carboxamides guided by structure-activity relationships (SARs) and the single crystal X-ray structure of compound 10. It was rationalized that the unexpectedly advantageous profiles of N-methylpyrimidinone carboxamides with a saturated C2-substitutent may be due, in part, to the geometric relationship between the C2-substituent and the pyrimidinone core. The single crystal X-ray structure of 10 provided support for this reasoning and guided the design of a spirocyclic series 12 which led to discovery of the morpholino-fused pyrimidinone series 13...
May 14, 2018: Bioorganic & Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/29779485/tgn-1412-and-bia-2474-trials-with-tragic-end-lessons-learnt-to-make-clinical-trials-safer
#18
Rimple Jeet Kaur, Surjit Singh, Preeti Sidhu, Pramod Kumar Sharma
BACKGROUND: Globally, there have been tremendous efforts by regulatory authorities to make clinical trials safer by making stringent clinical trial regulations. Despite this, we witnessed several tragic events. TGN1412 and BIA 10-2474 phase I trials are infamous trails in which healthy volunteers either succumbed to severe adverse effects or faced irreversible impairments of the test drug. Such afflictions in clinical trials are not only turbulent to the image of pharmaceutical industry but it also conveys dispiriting message for clinical trial participants...
May 20, 2018: Reviews on Recent Clinical Trials
https://www.readbyqxmd.com/read/29779350/-a-phase-%C3%A2-multi-center-clinical-trial-on-safety-and-efficacy-of-a-domestic-plasma-derived-factor-%C3%A2-for-the-treatment-of-patients-with-hemophilia-b
#19
W Liu, R F Fu, Y W Zhou, Y Chen, J Yin, Z Q Yu, L H Yang, M F Wang, H Bi, Z P Zhou, X S Zhang, J L Xia, R C Yang
Objective: To evaluate the efficacy and safety of a domestic human plasma derived coagulation Factor Ⅸ concentrate (pd-FⅨ) in patients with hemophilia B. Methods: The study was a multicenter, open-label and single-arm study. The efficacy of pd-F Ⅸ was evaluated by objective performance criteria. The doses of pd-FⅨ were calculated according to the bleeding symptom and disease severity. The infusion efficiency of pd-FⅨ and improvement of bleeding symptoms were measured at 30 minutes and (24±4) h after the first infusion, respectively...
May 14, 2018: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/29779024/a-randomized-clinical-trial-of-metformin-to-treat-autosomal-dominant-polycystic-kidney-disease
#20
Stephen L Seliger, Kaleab Z Abebe, Kenneth R Hallows, Dana C Miskulin, Ronald D Perrone, Terry Watnick, Kyongtae Tae Bae
BACKGROUND: Metformin inhibits cyclic AMP generation and activates AMP-activated protein kinase (AMPK), which inhibits the cystic fibrosis transmembrane conductance regulator and Mammalian Target of Rapamycin pathways. Together these effects may reduce cyst growth in autosomal dominant polycystic kidney disease (ADPKD). METHODS: A phase II, double-blinded randomized placebo-controlled trial of 26 months duration. Participants will include nondiabetic adults (n = 96) aged 18-60 years, with an estimated glomerular filtration rate (eGFR) ≥50 mL/min/1...
May 18, 2018: American Journal of Nephrology
keyword
keyword
48709
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"