scholarly journals Design of a field trial to develop a tabletop platform for rapid detection of XDR-TB in clinical samples (Preprint)

2020 ◽  
Author(s):  
Naomi Hillery ◽  
Marva Seifert ◽  
Donald G Catanzaro ◽  
Symone McKinnon ◽  
Rebecca E Colman ◽  
...  
Keyword(s):  
Clinical Study ◽  
Data Collection ◽  
Study Design ◽  
Human Subjects ◽  
Bacterial Load ◽  
Objective Evaluation ◽  
Clinical Samples ◽  
Prospective Clinical Study ◽  
Global Public Health ◽  
Drug Concentrations

BACKGROUND Extensively drug-resistant tuberculosis (XDR-TB) continues to be a serious threat to global public health, due in part to the lack of accurate and efficient diagnostic devices for XDR-TB. A prospective clinical study in an intended-use cohort was designed to evaluate the Akonni Biosystems XDR-TB TruArray® and Lateral Flow Cell (XDR-LFC), which has the potential to address this gap in TB diagnostics. OBJECTIVE The objective of this publication is to share documentation of the study conceptualization and design that is replicable and of use to the scientific community. METHODS This clinical study was conducted in three phases, the first to observe changes in bacterial load and culture positivity in patient sputa over time and better understand the diversity of prospective clinical samples, the second to prospectively collect clinical samples for sensitivity and specificity testing of the Akonni Biosystems XDR-LFC device, and the third to explore anti-TB drug concentrations in serum over the course of DR-TB treatment. RESULTS The methodology described includes the study design, laboratory sample handling, data collection, and human subjects protection elements of the clinical study to evaluate a potential new XDR-TB diagnostic device. The complex systems implemented facilitated thorough clinical data collection for objective evaluation of the device. This trial is closed to recruitment. Follow-up data collection and analysis are in progress. CONCLUSIONS This publication outlined the methods used in a prospective cohort study to evaluate a device to rapidly detect XDR-TB. The documentation of this clinical study design may be of use to other researchers with similar goals.

scholarly journals Complications associated with splenectomy in thalassemia

2016 ◽  
Vol 11 (4) ◽  
Author(s):  
Farogh Zahra ◽  
Muhammad Ashraf ◽  
Muhammad Aslam ◽  
Qaim Deen ◽  
Javeria Mannan
Keyword(s):  
Clinical Study ◽  
Study Design ◽  
Perioperative Management ◽  
Late Complications ◽  
Prospective Clinical Study ◽  
Massive Splenomegaly ◽  
Study Materials ◽  
Operative Complications ◽  
Post Operative Complications

Aims and Objectives: The study aims at investigating the complications associated with splenectomy in thalassemic patients Study Design: It was a prospective clinical study. Materials and Method: Sixty Splenectomies were preformed electively after pre-operative preparation in Sir Ganga Ram Hospital, Lahore during the year Jan 2003 to Sep 2005. Results: Complications were categorized into per-operative, early post-operative and late complications. The frequency of per-operative complications was 3%, early post-operative complications were 10% and late complications were 1.6%. Interpretation and Conclusion: The rate of complications has decreased markedly as the patients are well prepared and improved post operative carp has also reduced the post-operative complications. With good perioperative management, splenectomy in children with massive splenomegaly is both safe and effective.

Dermatophytosis of the Ear

2005 ◽  
Vol 133 (1) ◽  
pp. 113-115
Author(s):  
Setsuko Morinaka
Keyword(s):  
Seasonal Variation ◽  
Clinical Study ◽  
Dimethyl Sulfoxide ◽  
Study Design ◽  
Potassium Hydroxide ◽  
Clinical Characteristics ◽  
Prospective Clinical Study

OBJECTIVES: The prevalence and characteristics of patients with and without dermatophytosis of the ear were investigated. STUDY DESIGN AND SETTING: Prospective clinical study. In 54 patients who complained of slight itching or accumulation of cerumen, and/or who had erythema and scales in the ears, the presence of dermatophytosis was examined by potassium hydroxide and dimethyl sulfoxide (KOH-DMSO test). RESULTS: Nineteen patients had dermatophytosis of the ear. Dermatophytosis was more frequent in May and June. Other clinical characteristics did not differ markedly from those without dermatophytosis. CONCLUSION: About one third of patients had dermatophytosis and their characteristics were similar to those of patients without dermatophytosis except for seasonal variation. SIGNIFICANCE: Dermatophytosis of the ear may be increased. Its diagnosis is difficult without the KOH-DMSO test.

scholarly journals Invisible Participants: Recommendations for Researchers Using Crowdsourcing Platforms for Human Subjects Research

2019 ◽  
Author(s):  
Clair Morrissey ◽  
Myka Yamasaki ◽  
Carmel Levitan
Keyword(s):  
Data Collection ◽  
Study Design ◽  
Human Subjects ◽  
Research Participation ◽  
Large Datasets ◽  
Human Subjects Research ◽  
Ethical Considerations ◽  
Ethical Concerns ◽  
Fair Compensation ◽  
The Relationship

Increasingly, behavioral scientists rely on crowdsourcing platforms (e.g., Amazon’s MTurk) to collect large datasets rapidly and inexpensively. However, by heightening the distance between participants and researchers, these platforms render the participants “invisible,” and thereby raise ethical concerns related to participant autonomy. Moreover, because many participants use these platforms to earn a living, researchers must consider issues of fair compensation, and the relationship between employment and research participation. We present an overview of ethical considerations raised by the invisibility of crowdsourced research participants, including recommendations for researchers to consider in deciding whether and how to utilize these platforms. Specifically, we recommend that researchers: explore alternatives that distinguish research from employment; strengthen participant-research communication, including by recognizing and utilizing participant expertise in study design; and, explore alternatives that do not require “payment,” or, barring that, determine and pay appropriate compensation. We conclude by locating these ethical considerations in the context of broader calls for more thoughtful data collection.

Prospective Clinical Study of Bleeding Sites in Idiopathic Adult Posterior Epistaxis

2007 ◽  
Vol 137 (3) ◽  
pp. 390-393 ◽  
Author(s):  
Tor W. Chiu ◽  
Gerry W. McGarry
Keyword(s):  
Clinical Study ◽  
Prospective Study ◽  
General Anesthesia ◽  
Nasal Cavity ◽  
Study Design ◽  
Teaching Hospital ◽  
Prospective Clinical Study ◽  
Bleeding Site ◽  
Bleeding Point ◽  
Efficient Management

OBJECTIVES: The precise identification of the bleeding point is important to the efficient management of epistaxis. Our hypothesis was that the septum was the commonest bleeding site. STUDY DESIGN AND SETTING: This was a prospective clinical study of 50 consecutive adult idiopathic posterior epistaxis patients carried out in a busy teaching hospital. METHODS: The nasal cavity was inspected with endoscopy to identify the site of bleeding before any intervention. The location of bleeding sites was recorded on a proforma. RESULTS: Of bleeding sites posterior to the piriform fossa, 94 percent were identifiable, with 70 percent arising from the septum. CONCLUSIONS AND SIGNIFICANCE: This is the largest prospective study of the bleeding site in adult patients with posterior epistaxis and the only one with a well-defined population. The vast majority of posterior bleeding sites can be identified by endoscopy without general anesthesia. The septum should be examined closely in cases of idiopathic bleeding.

Minimizing Carry-Over Effects After Treatment Failure and Maximizing Therapeutic Outcome

2014 ◽  
Vol 222 (3) ◽  
pp. 171-178 ◽  
Author(s):  
Mareile Hofmann ◽  
Nathalie Wrobel ◽  
Simon Kessner ◽  
Ulrike Bingel
Keyword(s):  
Treatment Failure ◽  
Human Subjects ◽  
Subsequent Treatment ◽  
Clinical Samples ◽  
Administration Route ◽  
Healthy Human ◽  
Negative Experiences ◽  
Analgesic Treatment ◽  
Balanced Design ◽  
Carry Over

According to experimental and clinical evidence, the experiences of previous treatments are carried over to different therapeutic approaches and impair the outcome of subsequent treatments. In this behavioral pilot study we used a change in administration route to investigate whether the effect of prior treatment experience on a subsequent treatment depends on the similarity of both treatments. We experimentally induced positive or negative experiences with a topical analgesic treatment in two groups of healthy human subjects. Subsequently, we compared responses to a second, unrelated and systemic analgesic treatment between both the positive and negative group. We found that there was no difference in the analgesic response to the second treatment between the two groups. Our data indicate that a change in administration route might reduce the influence of treatment history and therefore be a way to reduce negative carry-over effects after treatment failure. Future studies will have to validate these findings in a fully balanced design including larger, clinical samples.

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