scholarly journals Cartilage repair and the sprifermin story: mechanisms, preclinical and clinical study results, and lessons learned

2016 ◽  
Vol 24 ◽  
pp. S4
Author(s):  
N. Muurahainen
Keyword(s):  
Clinical Study ◽  
Cartilage Repair ◽  
Lessons Learned ◽  
Study Results

scholarly journals Disseminating clinical study results to trial participants in Ethiopia: insights and lessons learned

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Tamiru S. Degaga ◽  
Sophie Weston ◽  
Tedla T. Tego ◽  
Dagimawie T. Abate ◽  
Ashenafi Aseffa ◽  
...  
Keyword(s):  
Clinical Study ◽  
Lessons Learned ◽  
Study Results ◽  
Trial Participants

scholarly journals Robust Step Detection from Different Waist-Worn Sensor Positions: Implications for Clinical Studies

2020 ◽  
Vol 4 (1) ◽  
pp. 50-58
Author(s):  
Matthias  Tietsch ◽  
Amir Muaremi ◽  
Ieuan Clay ◽  
Felix Kluge ◽  
Holger Hoefling ◽  
...  
Keyword(s):  
Clinical Study ◽  
Clinical Studies ◽  
Neurological Diseases ◽  
Human Gait ◽  
Robust Solution ◽  
Step Detection ◽  
Study Protocols ◽  
Study Results ◽  
Wide Range ◽  
The Impact

Analyzing human gait with inertial sensors provides valuable insights into a wide range of health impairments, including many musculoskeletal and neurological diseases. A representative and reliable assessment of gait requires continuous monitoring over long periods and ideally takes place in the subjects’ habitual environment (real-world). An inconsistent sensor wearing position can affect gait characterization and influence clinical study results, thus clinical study protocols are typically highly proscriptive, instructing all participants to wear the sensor in a uniform manner. This restrictive approach improves data quality but reduces overall adherence. In this work, we analyze the impact of altering the sensor wearing position around the waist on sensor signal and step detection. We demonstrate that an asymmetrically worn sensor leads to additional odd-harmonic frequency components in the frequency spectrum. We propose a robust solution for step detection based on autocorrelation to overcome sensor position variation (sensitivity = 0.99, precision = 0.99). The proposed solution reduces the impact of inconsistent sensor positioning on gait characterization in clinical studies, thus providing more flexibility to protocol implementation and more freedom to participants to wear the sensor in the position most comfortable to them. This work is a first step towards truly position-agnostic gait assessment in clinical settings.

scholarly journals Lessons learned: intentional implementation of second makerspaces

2019 ◽  
Vol 47 (1) ◽  
pp. 37-47 ◽  
Author(s):  
Heather Moorefield-Lang
Keyword(s):  
Design Methodology ◽  
Design Thinking ◽  
Planning Process ◽  
Research Participant ◽  
Lessons Learned ◽  
The Body ◽  
Planning Study ◽  
Content Type ◽  
Scholarly Publications ◽  
Study Results

Purpose What happens when a librarian outgrows their maker learning location or transfers to a new library? The purpose of this study is to explore the planning process for second and/or new library makerspaces. Is the planning more intentional? Is there more focus on how the makerspace should be put together for the community served? Is the community further involved? This study will explore those questions and more. Design/methodology/approach Using content analysis, the perspectives of practicing librarians in the achievement of subsequent makerspaces are examined. Data include librarian interviews, an analysis using NVivo 11 through the lens of design thinking, and a final review using member checking by each research participant. Findings Makerspaces continue to grow in popularity in school and public/community libraries. What is unexplored is the moving from a first makerspace to the implementation of a second and/or new maker learning location. More intentional planning is involved. The community served by the library is further engaged in the planning. Study results illustrate the value that community insight and intentional planning play in the design and implementation of makerspaces. Originality/value Makerspaces in libraries continue to grow in popularity; in turn, the body of peer-reviewed, scholarly publications also continues to grow. Librarians in the field are beginning to move from their first to second makerspaces. This study investigates those perspectives. Much can be gained from the experiences of those who have implemented their second or third makerspace.

scholarly journals Pharmacological and clinical study results of trastuzumab deruxtecan (T-DXd, ENHERTU®)

2021 ◽  
Vol 156 (1) ◽  
pp. 47-51
Author(s):  
Kaku Saito ◽  
Reina Kaneko ◽  
Takahiro Kamio ◽  
Emi Kamiyama ◽  
Ryo Muto ◽  
...  
Keyword(s):  
Clinical Study ◽  
Study Results

scholarly journals Power and Decision Making in the Early Church

2020 ◽  
Vol 1 (2) ◽  
pp. 9-20
Author(s):  
Seth Akhilele
Keyword(s):  
Decision Making ◽  
Conflict Resolution ◽  
Organizational Behavior ◽  
Leadership Style ◽  
Leadership Behavior ◽  
Power Distance ◽  
Lessons Learned ◽  
Power Sharing ◽  
Early Church ◽  
Study Results

Abstract In this article, there is the intersection of biblical principles into the teaching and learning of organizational behavior. It examined the crisis in the early Church, as told in the Luke account of Acts of the Apostles Chapter six, and how the leaders decided to resolve the conflict. The exegetical analysis method revealed the lessons learned from the apostolic leaders’ decision-making strategy and the power play in their leadership style. The results included the need for decision making for conflict resolution, decision and empowerment, power distance advantage, and power-sharing advantage in the early Church. The decision-making style for resolving the conflict in the Church was then recommended for contemporary church leaders, in teaching organizational leadership behavior in Christian schools, and in practice in other organizations. The study results suggest that the Bible is a rich source of data for teaching organizational behavior. Keywords: Low-power distance, conflict resolution, decision making, church, power-sharing.

Reaching the “Hard-to-Reach”: Recruitment of Rural-Dwelling Adults With Disabilities

2019 ◽  
Vol 31 (2) ◽  
pp. 171-177 ◽  
Author(s):  
Whitney A. Thurman ◽  
Tracie C. Harrison
Keyword(s):  
Lessons Learned ◽  
Recruitment Strategies ◽  
Rural America ◽  
Professional Networks ◽  
Research Recruitment ◽  
Adults With Disabilities ◽  
Recruitment Methods ◽  
Study Results ◽  
Hard To Reach Populations ◽  
Rural Dwellers

Introduction: There are 46 million individuals living in rural America that require unique consideration for rural health research. Recruitment of research participants from disparity groups can be difficult as these groups can be hard-to-reach. In particular, strategies for reaching rural-dwelling Americans with disabilities are not well-documented. Furthermore, researchers sometimes underestimate the time and effort needed to recruit participants from hard-to-reach populations. The purpose of this article is to report the methods used to recruit 12 rural-dwelling adults with disabilities into a qualitative study. Method: The recruitment strategies discussed in this article were used in a grounded theory study. Results: Fifty percent of the sample in this study was recruited via a community gatekeeper, 33% responded to a classified advertisement, and 17% were recruited via the researchers’ professional networks. Discussion: Lessons learned yield insights as to effective recruitment methods for rural dwellers as well as other hard-to-reach populations.

Usefulness of a Metal Artifact Reduction Algorithm for Orthopedic Implants in Abdominal CT: Phantom and Clinical Study Results

2015 ◽  
Vol 204 (2) ◽  
pp. 307-317 ◽  
Author(s):  
Seonji Jeong ◽  
Se Hyung Kim ◽  
Eui Jin Hwang ◽  
Cheong-il Shin ◽  
Joon Koo Han ◽  
...  
Keyword(s):  
Clinical Study ◽  
Orthopedic Implants ◽  
Artifact Reduction ◽  
Metal Artifact ◽  
Metal Artifact Reduction ◽  
Reduction Algorithm ◽  
Abdominal Ct ◽  
Study Results

An analysis of deficiencies identified during investigational new drug (IND) application reviews by the Division of Drug Oncology Products (DDOP) of the US FDA

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6052-6052
Author(s):  
B. S. Mann ◽  
R. Kane ◽  
M. Brave ◽  
Q. Ryan ◽  
M. Hazarika ◽  
...  
Keyword(s):  
Clinical Study ◽  
Study Protocol ◽  
Drug Dose ◽  
Stopping Criteria ◽  
Study Results ◽  
The Us ◽  
Clinical Hold ◽  
Dose Study ◽  
Study Population ◽  
Us Fda

6052 Background: Regulations require IND application review by the FDA prior to initiation of the clinical study. Deficiencies identified in the study protocol require communication between the FDA reviewers and the Sponsor for resolution. If the deficiencies are not adequately resolved, clinical hold and subsequent delay in the start of the clinical study results. To identify and analyze the commonly encountered IND application deficiencies, data from recent reviews were collected. Methods: Eight clinical reviewers analyzed the deficiencies that had been identified in 268 IND applications reviewed in the DDOP FDA from January 2003 to June 2005. All of the study protocol deficiencies leading to a clinical hold, or requiring resolution prior to study initiation were categorized as deficiencies pertaining to: patient eligibility; starting drug dose; study conduct (toxicity management, dose adjustment, stopping criteria); statistical or endpoints; non-clinical; and other issues. Results: 268 IND applications reviewed over a 30-month period by eight medical officers were analyzed. One hundred and twelve (42%) of the applications had no deficiencies; however, 156 (58%) had one (31%) or multiple (69%) deficiencies. Deficiencies pertained to study conduct/scheme (65%), dose (48%), patient eligibility (46%), others (31%), statistics or endpoints (15%), and non-clinical (4%) issues. In 141 (90%) of the deficient applications the deficiencies were adequately addressed by FDA reviewer-Sponsor communication and the trials could start as scheduled. Fifteen (10%) deficient trials were placed on clinical hold. Fourteen (93%) of these trials had multiple deficiencies that pertained to patient eligibility in 12 (80%), starting drug dose in 12 (80%), study conduct in 11 (73%), other in 7 (47%), and non-clinical and statistical issues in 2 (13%) each. Conclusions: Deficiencies were identified in 58% of the reviewed IND applications: 90% of these were resolved by FDA-Sponsor communication. Only 10% of deficient studies were placed on clinical hold; all except one had multiple deficiencies. The most common deficiencies leading to clinical hold pertained to eligibility of study population and proposed starting drug dose. No significant financial relationships to disclose.

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