Results 21 to 30 of about 60,343,578 (236)

Final Rule: HHS and NIH’s New Information Requirements for Clinical Trials

Voices in Bioethics, 2016
On September 16, 2016, the U.S. Department of Health and Human Services (HHS) presented a final rule, in conjunction with a complementary policy of the National Institutes of Health (NIH), amending Tile 42, Chapter 1 of the Code of Federal Regulations[1].
Jorge Luis Rivera-Agosto
doaj   +1 more source

Modified isotonic regression based phase I/II clinical trial design identifying optimal biological dose

, 2023
Conventional phase I/II clinical trial designs often use complicated parametric models to characterize the dose-response relationships and conduct the trials.
Liu, Hao, Zang, Yong, Cao, Sha, Zhao, Yi, Zhang, Chi, Qiu, Yingjie   +5 more
core   +1 more source

Managing clinical trials. [PDF]

, 2010
Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists ...
Barbara Farrell, Shakur Haleema, Farrell Barbara, Haleema Shakur, Farrell, B, Kenyon, Sara, Shakur, Haleema, Kenyon, Sara; id_orcid, Shakur, H, Kenyon Sara, Sara Kenyon, Farrell, Barbara   +11 more
core   +2 more sources

Final results of a phase I/II pilot study of capecitabine with or without vinorelbine after sequential dose-dense epirubicin and paclitaxel in high-risk early breast cancer [PDF]

, 2010
Background: The integration of the non-cross-resistant chemotherapeutic agents capecitabine and vinorelbine into an intensified dose-dense sequential anthracycline- and taxane-containing regimen in high-risk early breast cancer (EBC) could improve ...
Schmidt Marcus, Hinke Axel, Volkmar Müller, Heilmann Volker, Borowicz, Henryk, Lehnert, Antje, Volker Heilmann, Müller, Volkmar, Axel Hinke, Jackisch, Christian, Möbus, Volker, Christoph Thomssen, Marcus Schmidt, Thomssen, Christoph, Jackisch Christian, Antje Lehnert, Lehnert Antje, Christian Jackisch, Schmidt, Marcus, Glados, Manfred, Heilmann, Volker, Manfred Glados, Volker Möbus, Thomssen Christoph, Henryk Borowicz, Borowicz Henryk, Müller Volkmar, Möbus Volker, Hinke, Axel, Glados Manfred   +29 more
core   +2 more sources

Early Body Mass Index z‐Score Change and Resolution of Severe Malnutrition in Children With Sickle Cell Anemia in a Low‐Income Setting: A Prospective Single‐Arm Extension Study

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Children with sickle cell anemia (SCA) in low‐income settings are at risk of severe malnutrition, but optimal nutritional management has not been established. We evaluated an intensified ready‐to‐use therapeutic food (RUTF) regimen in children with persistent severe malnutrition after initial treatment and assessed whether early ...
Safiya Gambo, Shehu Umar Abdullahi, Hassan Adam Murtala, Halima Kabir, Khadija A. Shamsu, Sari A. Acra, Virginia A. Stallings, Mark Rodeghier, Michael R. DeBaun, Lauren J. Klein   +9 more
wiley   +1 more source

Social Functioning Within the First Years After Pediatric Brain Tumor Diagnosis and the Relationship With Family Psychosocial Risk

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Survivors of pediatric brain tumors (PBTs) can experience long‐term social difficulties, impacting quality of life. Beyond medical and environmental factors, family psychosocial risk may play a role in social outcomes by shaping the caregiving environment and may provide intervention options.
Renske H. Houben, Marisa H. Huisman, Martha A. Grootenhuis, Femke K. Aarsen, Marita Partanen   +4 more
wiley   +1 more source

Dietary Interventions in Parkinson’s Disease

Journal of Parkinson’s Disease
Several dietary patterns and nutritional supplements have been linked to the development, progression, and symptomatic treatment of Parkinson’s disease (PD).
Indy van der Berg, Sabine Schootemeijer, Karin Overbeek, Bastiaan R. Bloem, Nienke M. de Vries   +4 more
doaj   +1 more source

Retrospective Analysis of Donor Lymphocyte Infusions in Pediatric Patients With Mixed Chimerism After Hematopoietic Stem Cell Transplantation

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Allogeneic hematopoietic stem cell transplantation (alloHSCT) is an essential therapy for several malignant and nonmalignant diseases, but relapse and graft loss remain the principal threats to its success. Routine monitoring of chimerism and minimal residual disease (MRD) enables early detection of imminent recurrence and guides ...
Carmen Junk, Sebastian Michaelis, Michaela Döring, Thomas Eichholz, Ursula Holzer, Martin Ebinger, Tim Flaadt, Rupert Handgretinger, Peter Lang, Jan Frederic Weller, Markus Mezger   +10 more
wiley   +1 more source

High-dose vitamin C as a targeted treatment for KRAS-driven cancers?

Redox Biology
KRAS mutations are frequently observed in human cancer and are associated with proliferation, therapy-resistance and worse outcome. Regrettably, only a fraction of possible mutations is druggable.
Elisabeth Mack, Christian Rau, Cornelia Otet, Jonas Aaron Schäfer, Cornelia Brendel, Albert Grass, Peer Bredow, Christian Hohl, Carsten Denkert, Frank Willeke, Andreas Neubauer   +10 more
doaj   +1 more source

Therapeutic Apheresis in Nigeria: A Multi‐Center Summary of Abstracts From the Inaugural Nigerian Society for Apheresis Scientific Meeting

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Background Therapeutic apheresis (TA) is an established treatment modality for hematologic, neurologic, and immunologic disorders, yet access remains severely limited in sub‐Saharan Africa. Donor apheresis, including platelet apheresis collection from healthy donors, represents an important complementary modality supporting blood product ...
Nosa Bazuaye, Chimezie Okwuonu, Evelyn Idam, Folasade Adelekan‐Popoola, Shakirat Gold‐Olufadi, Olufunto Olufela Kalejaiye, Abdullateef Ogala, Zinnah Aloziem, Blossom Amamchukwu, Patience Elimia, Mkpoikanabasi Obot‐Obot, Henry Mbakwe, Praises Maduagwuna, Olatunji Akinrodoye, Chiamaka Anyanwu, Benjamin Anyanwu, Adedamola Akinsiku, Oluwatoyin A. Akinsiku, Muzamil O. Hassan, Fatiu A. Arogundade, Olalekan E. Ojo, Homayemem Weli, Jesupelumi Adenihun, Aderemi Adelaja, Ebun Bamgboye, Olalekan Olatise, Ade E. Faponle, Ayoola Odeyemi, Michael Muoka, Stephen Asaolu, Qudrat Busari, Blessing Dawudu, Michael Naiyeju, Rasheed A. Balogun   +33 more
wiley   +1 more source