Non-inferiority Evaluation of Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trials on the Safety and Efficacy of Full-suture Anchors for Rotator Cuff Injury and/or Shoulder Instability Surgery

2019 ◽  
Author(s):  
Keyword(s):  
Clinical Trials ◽  
Rotator Cuff ◽  
Shoulder Instability ◽  
Suture Anchors ◽  
Controlled Clinical Trials ◽  
Safety And Efficacy ◽  
Rotator Cuff Injury ◽  
Single Blind

Sonothrombolysis in Patients With Acute Ischemic Stroke With Large Vessel Occlusion: An Individual Patient Data Meta-Analysis

Stroke ◽  
2021 ◽  
Author(s):  
Georgios Tsivgoulis ◽  
Aristeidis H. Katsanos ◽  
Jürgen Eggers ◽  
Vincent Larrue ◽  
Lars Thomassen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Individual Patient Data ◽  
Intravenous Thrombolysis ◽  
Large Vessel ◽  
Large Vessel Occlusion ◽  
Controlled Clinical Trials ◽  
Vessel Occlusion ◽  
Safety And Efficacy ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

Background and Purpose: Evidence about the utility of ultrasound-enhanced thrombolysis (sonothrombolysis) in patients with acute ischemic stroke (AIS) is conflicting. We aimed to evaluate the safety and efficacy of sonothrombolysis in patients with AIS with large vessel occlusion, by analyzing individual patient data of available randomized-controlled clinical trials. Methods: We included all available randomized-controlled clinical trials comparing sonothrombolysis with or without addition of microspheres (treatment group) to intravenous thrombolysis alone (control group) in patients with AIS with large vessel occlusion. The primary outcome measure was the rate of complete recanalization at 1 to 36 hours following intravenous thrombolysis initiation. We present crude odds ratios (ORs) and ORs adjusted for the predefined variables of age, sex, baseline stroke severity, systolic blood pressure, and onset-to-treatment time. Results: We included 7 randomized controlled clinical trials that enrolled 1102 patients with AIS. A total of 138 and 134 confirmed large vessel occlusion patients were randomized to treatment and control groups respectively. Patients randomized to sonothrombolysis had increased odds of complete recanalization compared with patients receiving intravenous thrombolysis alone (40.3% versus 22.4%; OR, 2.17 [95% CI, 1.03–4.54]; adjusted OR, 2.33 [95% CI, 1.02–5.34]). The likelihood of symptomatic intracranial hemorrhage was not significantly different between the 2 groups (7.3% versus 3.7%; OR, 2.03 [95% CI, 0.68–6.11]; adjusted OR, 2.55 [95% CI, 0.76–8.52]). No differences in the likelihood of asymptomatic intracranial hemorrhage, 3-month favorable functional and 3-month functional independence were documented. Conclusions: Sonothrombolysis was associated with a nearly 2-fold increase in the odds of complete recanalization compared with intravenous thrombolysis alone in patients with AIS with large vessel occlusions. Further study of the safety and efficacy of sonothrombolysis is warranted.

Acamprosate for the Treatment of Alcohol Dependence: A Review of Double-Blind, Placebo-Controlled Trials

CNS Spectrums ◽  
2000 ◽  
Vol 5 (2) ◽  
pp. 58-69 ◽  
Author(s):  
Barbara J. Mason ◽  
Raymond L. Ownby
Keyword(s):  
Clinical Trials ◽  
Alcohol Dependence ◽  
Latin American ◽  
The United States ◽  
Concomitant Treatment ◽  
Controlled Clinical Trials ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo ◽  
Alcohol Dependent

AbstractAcamprosate (calcium acetyl-homotaurine) is a synthetic compound that crosses the blood-brain barrier and has a chemical structure similar to that of the naturally occurring amino acid neuromediators, homotaurine and γ-aminobu-tyric acid (GABA). Acamprosate appears to act primarily by restoring normal N-methyl-D-aspartate (NMDA) receptor tone in the glutamate system, and has been shown to have a specific dose-dependent effect on decreasing voluntary alcohol intake in animals with no effects on food and water consumption. The safety and efficacy of acamprosate in alcohol-dependent outpatients is currently under evaluation in the United States. Acamprosate has been available by prescription since 1989 in France and more recently in most European and Latin American coutries as well as Australia, South Africa, and Hong Kong. More than 4 million people have been treated with acamprosate since it became commercially available.The purpose of this article is to review all available double-blind, placebo-controlled clinical trials evaluating the safety and efficacy of acamprosate treatment of alcohol dependence. This work encompasses 16 controlled clinical trials conducted across 11 European countries and involves more than 4,500 outpatients with alcohol dependence. Fourteen of 16 studies found alcohol-dependent patients treated with acamprosate had a significantly greater rate of treatment completion, time to first drink, abstinence rate, and/or cumulative abstinence duration than patients treated with placebo. Additionally, a multinational open-label study of acamprosate in 1,281 patients with alcohol dependence found acamprosate to be equally effective across four major psychosocial concomitant treatment programs in maintaining abstinence and reducing consumption during any periods of relapse. An absence of known strong predictors of response to acamprosate, in conjunction with a modest but consistent effect on prolonging abstinence, and an excellent safety profile, lend support to the use of acamprosate across a broad range of patients with alcohol dependence.

Suture Anchors and Tacks for Shoulder Surgery, Part 1

2005 ◽  
Vol 33 (12) ◽  
pp. 1918-1923 ◽  
Author(s):  
Edward G. McFarland ◽  
Hyung Bin Park ◽  
Ekavit Keyurapan ◽  
Harpreet S. Gill ◽  
Harpal S. Selhi
Keyword(s):  
Rotator Cuff ◽  
Clinical Outcomes ◽  
Clinical Application ◽  
Shoulder Instability ◽  
Soft Tissues ◽  
Biceps Tendon ◽  
Surgical Techniques ◽  
Shoulder Surgery ◽  
Rotator Cuff Tears ◽  
Suture Anchors

The development and successful clinical application of suture anchors and tacks have revolutionized the surgeon's ability to secure soft tissues to bone via open or arthroscopic surgical techniques. When used carefully and with proper technique, these devices provide viable options for the repair and reconstruction of many intra-articular and extra-articular abnormalities in the shoulder, including rotator cuff tears, shoulder instability, and biceps lesions that require labrum repair or biceps tendon tenodesis. Like many technologies, however, the successful application of these devices requires an understanding of the biology and biomechanics that affect their use in the shoulder as well as knowledge of the factors that can affect subsequent clinical outcomes, including complications.

scholarly journals Nutraceutical Combinations in Hypercholesterolemia: Evidence from Randomized, Placebo-Controlled Clinical Trials

Nutrients ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 3128
Author(s):  
Olga Protic ◽  
Anna Rita Bonfigli ◽  
Roberto Antonicelli
Keyword(s):  
Clinical Trials ◽  
Synergistic Effects ◽  
Lipid Lowering ◽  
Red Yeast Rice ◽  
Controlled Clinical Trials ◽  
Safety And Efficacy ◽  
Single Compound ◽  
Single Effect ◽  
Almost All ◽  
Hypercholesterolemic Subjects

There is an increasing number of nutraceutical combinations (NCs) on the market for hypercholesterolemia, although clinical trials to verify their safety and efficacy are scarce. We selected fourteen randomized, placebo-controlled clinical trials (RCTs) on different lipid-lowering NCs in hypercholesterolemic subjects. We described each compound′s mechanism of action and efficacy in the mixtures and summarized the clinical trials settings and NCs safety and efficacy results. Almost all NCs resulted efficient against hypercholesterolemia; only one reported no changes. Interestingly, red yeast rice (RYR) was present in eleven mixtures. It is not clear whether the lipid-lowering efficacy of these combinations derives mainly from the RYR component monacolin K “natural statin” single effect. Up to now, few RCTs have verified the efficacy of every single compound vs. NCs to evaluate possible additive or synergistic effects, probably due to the complexity and the high resources request. In conclusion, to manage the arising nutraceutical tide against hypercholesterolemia, it could be helpful to increase the number and robustness of clinical studies to verify the efficacy and safety of the new NCs.

scholarly journals Alternative management of Covid-19 infection

2020 ◽  
Vol 65 (3) ◽  
pp. 72-75 ◽  
Author(s):  
Hasan I Atrah
Keyword(s):  
Clinical Trials ◽  
Therapeutic Agents ◽  
High Dose ◽  
Cytokine Storm ◽  
Controlled Clinical Trials ◽  
Safety And Efficacy ◽  
Wide Range ◽  
Life Threatening ◽  
Life Threatening Complication ◽  
Randomised Controlled

Cytokine storm is a life-threatening complication of Covid-19 infection. Excessive cytokines are the products of hyperactive immune inflammatory response mounted by the host against the virus. There is no agreed treatment for cytokine storm. Three therapeutic agents with proven immune-modulatory properties in regular use in a wide range of inflammatory disorders (high dose intravenous immunoglobulin, Rituximab and thalidomide) are proposed for the treatment of cytokine storm. Safety and efficacy of the proposed treatment should be assessed by randomised controlled clinical trials. The use of the proposed treatment is expected to reduce the mortality rate and alter the overall management of the pandemic.

scholarly journals Treating patients with compounds or biological agents that pass the safety-test

2016 ◽  
Author(s):  
Jianyi Zhang
Keyword(s):  
Clinical Trials ◽  
Clinical Setting ◽  
Patient Population ◽  
Review Process ◽  
Biological Agents ◽  
Controlled Clinical Trials ◽  
Safety And Efficacy ◽  
Medical Disorders ◽  
Safety Test ◽  
The U.S

There are numerous medical disorders without effective treatments. It is possible that many of un-treatable conditions need more than one compound co-operatively for improvement or cure. Approval of drugs in the U.S. is governed by a rigorous review process by the Food and Drug Administration (FDA) regulation. A sponsor must demonstrate the drug’s safety and efficacy in well controlled clinical trials in the proper patient population for which it is indicated. Development of a new compound entity (NCE) is a very costly and time-consuming process; it takes roughly 15 years and 1.5 billion dollars on average. The high cost of the process makes the development of a new drug with multiple NCEs almost impossible. There are many compounds or biological agents which pass the safety test, but fail in the efficacy test. Those compounds might be critical for treatment of these medical conditions. The author suggests that compounds or biological agents, which pass the safety test, but the fail in efficacy test, should be allowed to use in clinical setting. The safety of those compounds is comparable with any other drugs approved by FDA. Benefits would heavily outweigh risks for patients treated by those compounds. The same principle should also be applied to biological agents, such as vaccines against HIV infection, cancers, etc.

scholarly journals Treating patients with compounds or biological agents that pass the safety-test

2016 ◽  
Author(s):  
Jianyi Zhang
Keyword(s):  
Clinical Trials ◽  
Clinical Setting ◽  
Patient Population ◽  
Review Process ◽  
Biological Agents ◽  
Controlled Clinical Trials ◽  
Safety And Efficacy ◽  
Medical Disorders ◽  
Safety Test ◽  
The U.S

There are numerous medical disorders without effective treatments. It is possible that many of un-treatable conditions need more than one compound co-operatively for improvement or cure. Approval of drugs in the U.S. is governed by a rigorous review process by the Food and Drug Administration (FDA) regulation. A sponsor must demonstrate the drug’s safety and efficacy in well controlled clinical trials in the proper patient population for which it is indicated. Development of a new compound entity (NCE) is a very costly and time-consuming process; it takes roughly 15 years and 1.5 billion dollars on average. The high cost of the process makes the development of a new drug with multiple NCEs almost impossible. There are many compounds or biological agents which pass the safety test, but fail in the efficacy test. Those compounds might be critical for treatment of these medical conditions. The author suggests that compounds or biological agents, which pass the safety test, but the fail in efficacy test, should be allowed to use in clinical setting. The safety of those compounds is comparable with any other drugs approved by FDA. Benefits would heavily outweigh risks for patients treated by those compounds. The same principle should also be applied to biological agents, such as vaccines against HIV infection, cancers, etc.

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