scholarly journals PMU101 MOST BOTHERSOME SYMPTOM MEASUREMENT STRATEGIES: CONSIDERATIONS FOR REGULATED CLINICAL TRIALS

2019 ◽  
Vol 22 ◽  
pp. S267
Author(s):  
I. Mazar ◽  
S. Ollis ◽  
S. Li ◽  
A. Yaworsky ◽  
C. Gwaltney
Keyword(s):  
Clinical Trials ◽  
Bothersome Symptom ◽  
Symptom Measurement ◽  
Measurement Strategies

scholarly journals The efficacy of mirabegron in the treatment of urgency and the potential utility of combination therapy

2018 ◽  
Vol 10 (8) ◽  
pp. 243-256 ◽  
Author(s):  
Karl-Erik Andersson ◽  
Nurul Choudhury ◽  
Jean-Nicolas Cornu ◽  
Moses Huang ◽  
Cees Korstanje ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Combination Therapy ◽  
Combination Treatment ◽  
Primary Objective ◽  
Antimuscarinic Agent ◽  
Antimuscarinic Agents ◽  
Related Quality ◽  
Health Related ◽  
Bothersome Symptom ◽  
Clinical Benefits

Urgency is the prevalent and most bothersome symptom of overactive bladder (OAB) and the treatment of urgency is the primary objective in the management of OAB. Urgency has a major impact on other symptoms of OAB and culminates in an increased frequency of micturition and reduced volume voided, which may contribute to shorter intervals between the need to void. Antimuscarinic agents and mirabegron, a β3-adrenoceptor agonist, constitute the main oral pharmacotherapeutic options for the treatment of urgency and other OAB symptoms. The reduction of urgency and other OAB symptoms significantly improve health-related quality of life. This review will explore the distinct mechanisms of action and effects of antimuscarinic agents and mirabegron, in relation to their effect on the pathophysiology of urgency. The review will also provide an overview of the various validated measurements of urgency and the numerous clinical trials regarding antimuscarinic agent monotherapy, mirabegron monotherapy, or combination treatment with mirabegron added on to the antimuscarinic agent solifenacin. A narrative review of the literature relating to pathophysiology of urgency, the validated measurements of urgency, and clinical trials relating to the pharmacological treatment of urgency. Antimuscarinic agent monotherapy, mirabegron monotherapy, or combination treatment with mirabegron added on to the antimuscarinic agent solifenacin statistically significantly reduce the symptoms of urgency compared with placebo. Combination therapy with mirabegron added on to solifenacin also statistically significantly reduces the symptoms of severe urgency compared with antimuscarinic agent monotherapy. A critique of the clinical benefits of combination therapy is also provided. Combination therapy provides an alternative treatment in patients with OAB that includes urgency who respond poorly to first-line monotherapy and who may otherwise often move on to more invasive treatments.

The utility of daily mood ratings in clinical trials of patients with bipolar II disorder

2021 ◽  
pp. 103985622110142
Author(s):  
Gordon Parker ◽  
Tahlia Ricciardi ◽  
Gabriela Tavella ◽  
Michael J Spoelma
Keyword(s):  
Bipolar Disorder ◽  
Clinical Trials ◽  
Bipolar Ii Disorder ◽  
Standard Interval ◽  
Daily Monitoring ◽  
Daily Data ◽  
Bipolar Ii ◽  
Measurement Strategies ◽  
To Receive

Objective: To demonstrate that there can be distinctive differences in information generated by standard interval measures as against using daily monitoring for evaluating progress in those with a bipolar disorder. Method: We undertook a 20-week study of individuals with a bipolar II disorder randomly assigned to receive either lamotrigine or lithium. Patients were rated on standard measures of depression and hypomania at monthly intervals, and they also completed a daily rating measure of their mood swings. We sought to demonstrate the potential for differing interpretations that emerge from these measurement strategies. Results: We graphed data for one subject who showed distinct improvement but demonstrated distinctly differing trajectories provided by monthly and daily data. In a second analysis, we considered sets of those who were judged as improving distinctly with lithium or lamotrigine to determine whether the drugs differed in speed of action, and again observed differing patterns between monthly and daily rating measures. Conclusions: A daily rating strategy appeared to provide additional and differing data compared to standard monthly measures. We therefore argue for the inclusion of daily mood ratings in clinical trials evaluating mood stabilisers and their use by clinicians in managing those with a bipolar II disorder.

Localization of Gallium-67 in Peritoneal Cells by Electron Microscopic Autoradiography

1973 ◽  
Vol 31 ◽  
pp. 404-405
Author(s):  
D. C. Swartzendruber ◽  
Norma L. Idoyaga-Vargas
Keyword(s):  
Clinical Trials ◽  
Soft Tissue ◽  
Tumor Tissue ◽  
Soft Tissue Tumors ◽  
Clinical Usefulness ◽  
Electron Microscopic ◽  
Normal Cells ◽  
Electron Microscopic Autoradiography ◽  
Peritoneal Cells ◽  
Gallium 67

The radionuclide gallium-67 (67Ga) localizes preferentially but not specifically in many human and experimental soft-tissue tumors. Because of this localization, 67Ga is used in clinical trials to detect humar. cancers by external scintiscanning methods. However, the fact that 67Ga does not localize specifically in tumors requires for its eventual clinical usefulness a fuller understanding of the mechanisms that control its deposition in both malignant and normal cells. We have previously reported that 67Ga localizes in lysosomal-like bodies, notably, although not exclusively, in macrophages of the spocytaneous AKR thymoma. Further studies on the uptake of 67Ga by macrophages are needed to determine whether there are factors related to malignancy that might alter the localization of 67Ga in these cells and thus provide clues to discovering the mechanism of 67Ga localization in tumor tissue.

Rome I versus Rome II; Overlap in patients enrolled in tegaserod phase III clinical trials for irritable bowel syndrome (IBS)

2001 ◽  
Vol 120 (5) ◽  
pp. A284-A284
Author(s):  
B NAULT ◽  
S SUE ◽  
J HEGGLAND ◽  
S GOHARI ◽  
G LIGOZIO ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Irritable Bowel ◽  
Rome I

Clinical trials screening: An opportunity to increase medical care access

2001 ◽  
Vol 120 (5) ◽  
pp. A410-A410
Author(s):  
T KOVASC ◽  
R ALTMAN ◽  
R JUTABHA ◽  
G OHNING
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
Care Access
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