Clinical Trials Update

2009 ◽  
Vol 8 (2) ◽  
pp. 99-99
Keyword(s):  
Clinical Trials ◽  
Pulmonary Hypertension ◽  
Preliminary Results ◽  
Multicenter Clinical Trials

We would like to introduce you to a new section in Advances in Pulmonary Hypertension in which we highlight results from ongoing and recent clinical trials. The preliminary results of several multicenter clinical trials have recently been presented. In this issue, we will focus on the results of Freedom-C, which was presented in November of 2008, as well as the Walk-PHaSST study, which was stopped early in July 2009.

Clinical Trials Update

2013 ◽  
Vol 12 (3) ◽  
pp. 118-118
Author(s):  
Fernando Torres
Keyword(s):  
Clinical Trials ◽  
Pulmonary Hypertension ◽  
Left Ventricular Systolic Dysfunction ◽  
Systolic Dysfunction ◽  
Left Ventricular ◽  
Ventricular Systolic Dysfunction ◽  
Ongoing Research

The Clinical Trials Update highlights new and ongoing research trials that are evaluating therapies for PAH. In this issue, Fernando Torres, MD, examines a study on patients with pulmonary hypertension associated with left ventricular systolic dysfunction.

A Cultured Skin Substitute Composed of Fibroblasts and Keratinocytes with a Collagen Matrix: Preliminary Results of Clinical Trials

1993 ◽  
Vol 31 (4) ◽  
pp. 340-351 ◽  
Author(s):  
Yoshimitsu Kuroyanagi ◽  
Makoto Kenmochi ◽  
Shuichi Ishihara ◽  
Akira Takeda ◽  
Akihiko Shiraishi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Collagen Matrix ◽  
Skin Substitute ◽  
Preliminary Results ◽  
Cultured Skin

Long-term Clinical Trials in Pulmonary Hypertension

CHEST Journal ◽  
1986 ◽  
Vol 89 (1) ◽  
pp. 4-5 ◽  
Author(s):  
James Theodore ◽  
Conor M. Burke
Keyword(s):  
Clinical Trials ◽  
Pulmonary Hypertension

scholarly journals Comparison of functional outcomes from orthopedic and neurosurgical interventions in spastic diplegia

1998 ◽  
Vol 4 (1) ◽  
pp. E5 ◽  
Author(s):  
Mark F. Abel ◽  
Diane L. Damiano ◽  
John F. McLaughlin ◽  
Kit M. Song ◽  
Catherine S. Graubert ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Motor Function ◽  
Three Dimensional ◽  
Gait Velocity ◽  
Spastic Diplegia ◽  
Five Dimensions ◽  
Dorsal Rhizotomy ◽  
Multicenter Clinical Trials ◽  
Functional Outcome Measures ◽  
Post Hoc

Selective dorsal rhizotomy (SDR) and orthopedic surgery, in the form of muscle-tendon (MT) lengthening surgery are commonly performed in ambulatory children with spastic diplegia to improve their level of motor function. This investigation is a post hoc comparison of the functional effects from each of these surgical options in 30 patients with spastic diplegia who underwent one of these interventions as their initial surgical procedure. Sixteen children underwent SDR and 14 underwent MT surgery in two separate prospective clinical trials. The same functional outcome measures preoperatively and approximately 1 year postoperatively were used in both studies including temporospatial parameters from three-dimensional gait analysis, the total score, and score on each of the five dimensions of the Gross Motor Function Measure (GMFM). Comparisons indicate that patients who underwent SDR had significant improvements in GMFM Dimensions 2, 4, and 5 as well as in total score, although 63% of those studied had a 10% or more reduction in gait velocity. Gait was more predictably improved in the MT group, with only 21% demonstrating reductions in velocity. Conversely, the change in GMFM scores in the MT group was not as pervasive and skewed toward higher skills with only GMFM Dimension 5 and total score improved significantly. Several important hypotheses are derived from these comparisons. Multicenter clinical trials are needed to define more clearly the indications for and to assess more comprehensively the outcomes from each intervention.

scholarly journals Barriers and Solutions to Developing Future Therapies for Pulmonary Hypertension

2018 ◽  
Vol 17 (4) ◽  
pp. 159-165
Author(s):  
Brian Graham ◽  
Peter Fernandes ◽  
Sue Gu
Keyword(s):  
Clinical Trials ◽  
Pulmonary Hypertension ◽  
Phase 1 ◽  
Unmet Need ◽  
Orphan Drugs ◽  
World Health ◽  
Vasodilator Therapy ◽  
Scarce Resources ◽  
Pulmonary Arterial ◽  
Health Organization

Pulmonary hypertension (PH) and its subset, pulmonary arterial hypertension (PAH), are rare diseases with a significant unmet need. Between the 1980s and 2010s, the 5-year survival rate for PAH after diagnosis improved from 34% to 65%,12 but remains unacceptably low. Since the introduction of vasodilator therapy, 34 important advances have been made in the understanding of the disease pathophysiology and development of targeted therapies. There are now 14 US Food and Drug Administration (FDA)-approved therapies that target 3 distinct pathways that contribute to PAH, and additional therapeutic targets are currently under investigation in phase 1, 2, and 3 clinical trials.5 However, there have been major challenges in PH medication development to date, including: 1) only one medication approved for pediatric PAH; 2) focusing on vasodilator therapy rather than targeting the underlying pathogenesis of the disease; 3) no medications approved for PH World Health Organization (WHO) Groups 2, 3, and 5; and 4) several recent high-profile clinical failures after promising preclinical studies.The focus and goal of the PH research community should be directed at identifying new options and solutions for patients. The field must ensure that the approaches used for clinical trials to develop orphan drugs maximize the scarce resources available for recruiting subjects, and are directed toward making safe and effective therapies available in a timely manner. Therefore, there is a critical need to coordinate and harmonize innovative approaches within the field, including strengthening translational research to deliver promising candidates and optimize the designs, endpoints, and biomarkers to conduct safe and efficient clinical trials.

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