case study of clinical trials

This clinical trial case study discusses the process that led to the WATERFALL trial — from a question asked by a gastroenterology trainee more than two decades ago about fluid management in acute pancreatitis to the completed clinical trial published in the New England Journal of Medicine that...

A Neoadjuvant Chemotherapy Trial for Early Breast Cancer is Impacted by COVID-19: Addressing Vaccination and Cancer Trials Through Education, Equity, and Outcomes, Clinical Cancer Research, 27, 16 ...

Challenges Faced and Lessons Learned from Our Trial of VTE Prophylaxis. G. Le Gal and D. MottierNEJM Evid 2023;2 (9) In this Clinical Trials Case Study, the authors describe the challenges faced and lessons learned conducting a trial of venous thromboembolism prophylaxis among hospitalized older adults. Morning Report.

Oliguria developed. Additional laboratory studies were ... more appropriate. 2,5,15,22 Most of the clinical findings in this case could be ... trials of antiviral or ...

The study involves the recruitment of patients with disease X who are receiving one of three standard therapies as part of their clinical care. It is designed to assess the relative effectiveness of the three therapies by monitoring survival rates using medical records over a few years. Case #13b.

when the phase 2 study was relatively large and even when the phase 2 trials assessed clinical outcomes. In two cases, the phase 3 studies showed that the experimental product increased the ...

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Explore 498,692 research studies in all 50 states and in 222 countries. See listed clinical studies related to the coronavirus disease (COVID-19)

A case‐cohort study is similar to a nested case‐control study except that there is a defined sub‐cohort which forms the groups of individuals without the disease ... One of the earliest clinical trial studies was performed by James Lind et al in 1747 on sailors with scurvy. 12 Lind divided twelve scorbutic sailors into six groups of two ...

A case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports usually describe an unusual or novel occurrence and as such, remain one of the cornerstones of medical progress and provide many new ideas in medicine. Some reports contain an extensive review of the relevant ...

The WATERFALL randomized trial, published in the New England Journal of Medicine in 2022, showed that in patients with acute pancreatitis, early aggressive fluid resuscitation resulted in a higher incidence of fluid overload without improvement in clinical outcomes, compared with a moderate resuscitation strategy. This clinical trial case study discusses the process that led to the WATERFALL ...

Editorial. Introduction. Case reports and case series or case study research are descriptive studies to present patients in their natural clinical setting. Case reports, which generally consist of three or fewer patients, are prepared to illustrate features in the practice of medicine and potentially create new research questions that may contribute to the acquisition of additional knowledge ...

The primary estimand (a precise description of the treatment effect reflecting the objective of the clinical trial) assessed effects regardless of treatment discontinuation or rescue interventions ...

Clinical trials are conducted for many reasons: to determine whether a new drug or device is safe and effective for people to use. to study different ways to use standard treatments or current ...

Conduct a focused search of studies by matching one or more words entered in specific fields. See also How to Use Advanced Search. Find studies in categories such as condition, drug intervention, sponsor, or location. See also How to Find Studies by Topic or on a Map. Find studies by clicking on a country or region on a map.

Clinical trials are research studies that involve people. Often, a clinical trial might be the last treatment resort for a cancer patient when all other therapies have failed. Cancer clinical trials help doctors discover new and better ways to prevent, find, and treat cancer.

Clinical Case Studies (CCS), peer-reviewed & published bi-monthly electronic only, is the only journal devoted entirely to innovative psychotherapy case studies & presents cases involving individual, couples, & family therapy.The easy-to-follow case presentation format allows you to learn how interesting & challenging cases were assessed & conceptualized, & how treatment followed such ...

This study is a clinical trial. Case #8a: The study involves the recruitment of research participants with disease X. It is designed to compare the diagnostic performance of approved devices A and B, both of which are used in clinical practice, to measure disease markers. Device A will be used in half of the patients; device B will be used in

NIH Definition of a Clinical Trial. A research study in which one or more human subjects are prospectively assigned prospectively assigned The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or ...

Clinical Trial Basics. Learn about clinical trials, who conducts them, where they are conducted, why you might participate, and the benefits and risks to participating. NIH Clinical Research Trials and You Learn what clinical trials are, who participates, questions to ask about the trials, and your protections as a volunteer.

Case studies also provide valuable teaching material, demonstrating both classical and unusual presentations which may confront the practitioner. Quite obviously, since the overwhelming majority of clinical interactions occur in the field, not in teaching or research facilities, it falls to the field practitioner to record and pass on their ...

Is written by pharmaceutical industry experts, academic researchers, and regulatory reviewers; this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design. Has a broad appeal to a multitude of readers ...

Randall Cox. Ateka A. Contractor. Preview abstract. Free access Research article First published August 11, 2021 pp. 61-81. xml PDF / EPUB. Table of contents for Clinical Case Studies, 21, 1, Feb 01, 2022.

Thanks to advances in technology, data science, and infrastructure, the pace of discovery and innovation in cancer research has accelerated, producing an impressive range of potential new treatments and other interventions that are being tested in clinical studies.The extent of the innovative ideas that might help people live longer, improve our ability to detect cancer early, or otherwise ...

Clinical Research Study Investigator's Toolbox. The NIA Clinical Research Investigator's Toolbox is to provide a Web-based information repository for investigators and staff involved in clinical research. The Toolbox contains templates, sample forms, guidelines, regulations and information materials to assist investigators in the development ...

Furthermore, many clinical trials need to extend their study periods as they struggle to retain participants, which also adds to the costs. "Despite the fact that our trial is sort of built as a concierge service for each individual patient, it was much less expensive than what we had been doing," Krumholz says. "What I hope will happen ...

The aim of this study was to evaluate the effectiveness of team-, case-, lecture-, and evidence-based learning (TCLEBL) methods in cultivating students' clinical and research abilities, as compared to traditional lecture-based learning (LBL) approaches. Forty-one medical postgraduates were divided into two groups, a TCLEBL group and an LBL group.

Clinical research can also be classified into non-directed data capture, directed data capture, and drug trials. Clinical research could be prospective or retrospective. It may also be a case-control study or a cohort study. Clinical trials may be initiated to find treatment, prevent, observe, and diagnose a disease or a medical condition.

Graduate Entry Nursing (GEN) programmes have been introduced as another entry point to nurse registration. In the development of a new GEN programme, a problem-based approach to learning was used to develop critical thinking and clinical reasoning skills of motivated and academically capable students. To explore and evaluate the design and delivery of course material delivered to GEN students ...

Glossary. Study record managers: refer to the Data Element Definitions if submitting registration or results information.. Search for terms

The clinical case report has a long-standing tradition in the medical literature. While its scientific significance has become smaller as more advanced research methods have gained ground, case reports are still presented in many medical journals. ... This usage of case reports borders on qualitative research. Qualitative studies, although ...