scholarly journals Placebo and Side Effects Confound Clinical Trials on New Antitussives

Lung ◽  
2021 ◽  
Author(s):  
Ronald Eccles
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Placebo Effect ◽  
Trial Design ◽  
Fundamental Aspect ◽  
Treatment Side Effects ◽  
Information Trial ◽  
And Control ◽  
Participant Information ◽  
Made In

AbstractThis review discusses how the placebo effect related to treatment side effects may confound clinical trials on antitussives and specifically looks at the implications for trials on ATP antagonists. These new antitussives have distinctive side effects on the sensation of taste, and investigators have expressed concerns that this may unblind the clinical trials. Blinding is an essential component of trial design, but the degree of blinding in trials is rarely assessed. The assumptions of additivity and balance in clinical trials are discussed as important factors that allow assessment of the pharmacological activity of an antitussive. How side effects unbalance a clinical trial by amplifying the placebo effect of active treatments is discussed. The point is made that unblinding of trials invalidates any assessment of efficacy but that there is little interest or discussion about this fundamental aspect of trials. Proposals are discussed which may improve the blinding of trials and control placebo effects by changes to participant information, trial design, patient selection and use of active placebos. The issue of unblinding of clinical trials is not a new issue, but if real progress is to be made in developing new antitussives, then it is an issue that needs to be urgently addressed.

scholarly journals Using Topiramate in Patients with Epilepsy: Practical Aspects

1998 ◽  
Vol 25 (S3) ◽  
pp. S16-S18 ◽  
Author(s):  
J.W.A.S. Sander
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Optimum Level ◽  
Relative Efficacy ◽  
Efficacy And Safety ◽  
Patient Counseling ◽  
The United Kingdom ◽  
Number Of Patients ◽  
Patients With Epilepsy ◽  
Made In

ABSTRACT:Clinical trials are important in determining the relative efficacy and safety of a new antiepileptic drug (AED); however, experience acquired in clinical practice will eventually determine its position in the antiepileptic armamentarium. Topiramate (TPM), a new AED has been available in the United Kingdom since mid-1995 and a considerable number of patients have being treated. As a result of this experience, a number of changes have being made in the way TPM is used, particularly in the starting doses and titration rates. This seems to have improved patients' tolerability of treatment, an important consideration if a drug is to be used to its optimum level. In this article, practical tips for the use of TPM are given and these include starting doses, titration rates, options for managing side effects occurring early in treatment, advice concerning the withdrawal of concomitant AEDs and indications for discontinuation of TPM. The need for adequate patient counseling regarding potential side effects and expectations of treatment is also reviewed.

Effects of Virgin Coconut Oil as Adjunct Therapy in the Treatment of Allergic Rhinitis

2016 ◽  
Vol 1 (1) ◽  
pp. 22
Author(s):  
Nazli Zainuddin ◽  
Nurul Azira Mohd Shah ◽  
Rosdan Salim
Keyword(s):  
Allergic Rhinitis ◽  
Side Effects ◽  
Coconut Oil ◽  
Test Group ◽  
Nasal Symptom ◽  
Control Group ◽  
Virgin Coconut Oil ◽  
Control Groups ◽  
Significant Difference ◽  
And Control

Introduction: The role of virgin coconut oil in the treatment of allergic rhinitis is controversial. Thus, the aim of the present study is to determine the effects of virgin coconut oil ingestion, in addition to standard medications, on allergic rhinitis. We also studied the side effects of consumption of virgin coconut oil. Methods: Fifty two subjects were equally divided into test and control groups. All subjects received a daily dose of 10mg of loratadine for 28 days. The test group was given 10ml of virgin coconut oil three times a day in addition to loratadine. The symptoms of allergic rhinitis were scored at the beginning and end of the study. Results:, the symptom score were divided into nasal and non-nasal symptom scores. Sneezing score showed a significant difference, however the score was more in control group than test group, indicating that improvement in symptom was more in control group. The rest of the nasal symptom and non-nasal symptom score showed no significant difference between test and control groups. Approximately 58% of the test subjects developed side effects from consumption of virgin coconut oil, mainly gastrointestinal side effects. Conclusion: In the present study, ingestion of virgin coconut oil does not improve the overall and individual symptoms of allergic rhinitis, furthermore it has side effects.

An Efficient Approach for Modeling and Control of a Quadrotor

2016 ◽  
Vol 4 (2) ◽  
pp. 1-16
Author(s):  
Ahmed S. Khusheef
Keyword(s):  
Pid Control ◽  
Control Method ◽  
Mechanical Design ◽  
Loop Control ◽  
Modeling And Control ◽  
Loop Control System ◽  
And Control ◽  
Close Loop Control ◽  
Close Loop Control System ◽  
Made In

 A quadrotor is a four-rotor aircraft capable of vertical take-off and landing, hovering, forward flight, and having great maneuverability. Its platform can be made in a small size make it convenient for indoor applications as well as for outdoor uses. In model there are four input forces that are essentially the thrust provided by each propeller attached to each motor with a fixed angle. The quadrotor is basically considered an unstable system because of the aerodynamic effects; consequently, a close-loop control system is required to achieve stability and autonomy. Such system must enable the quadrotor to reach the desired attitude as fast as possible without any steady state error. In this paper, an optimal controller is designed based on a Proportional Integral Derivative (PID) control method to obtain stability in flying the quadrotor. The dynamic model of this vehicle will be also explained by using Euler-Newton method. The mechanical design was performed along with the design of the controlling algorithm. Matlab Simulink was used to test and analyze the performance of the proposed control strategy. The experimental results on the quadrotor demonstrated the effectiveness of the methodology used.

EFFICACY OF TENOFOVIR IN PATIENTS OF HBV-RELATED CIRRHOSIS

2016 ◽  
pp. 25-29
Author(s):  
Van Huy Tran ◽  
Thi Huyen Thuong Nguyen
Keyword(s):  
Side Effects ◽  
Serum Creatinine ◽  
Key Words ◽  
Tenofovir Disoproxil Fumarate ◽  
Hbv Dna ◽  
Treatment Side Effects ◽  
Background Data ◽  
Key Words Cirrhosis

Background: Data about efficacy of Tenofovir in patients of HBV –related cirrhosis in Vietnam was still limited. This study is aimed at: - evaluating the clinical, biochemical, virological and Child-Pugh score responses 3,6,9 months after Tenofovir therapy; - assessing possible side effects of tenofovir. Patients and methods: 40 patients with HBV-related cirrhosis were enrolled. All has received Tenofovir disoproxil fumarate 300mg/day. Follow-up after 3,6 and 9 months. Results: Anorexia, oedema and ascites were significantly improved after treatment. HBV DNA became undetectable in 92.5%, 94.55 and 100% after 3,6 and 9 months, respectively. Child- Pugh score was improved after treatment (5.94±0.22 after treatment vs 7.47±0.28 before treatment). Side effects were minors (nausea, vomiting). No case of increase in serum creatinine was found. Conclusion: Tenofovir showed effective and safe in patients of HBV-related cirrhosis. Key words: Cirrhosis, tenofovir, HBV. Key words: cirrhosis, tenofovir, HBV

Biological Production of (S)-acetoin: A State-of-the-Art Review

2019 ◽  
Vol 19 (25) ◽  
pp. 2348-2356 ◽  
Author(s):  
Neng-Zhong Xie ◽  
Jian-Xiu Li ◽  
Ri-Bo Huang
Keyword(s):  
Side Effects ◽  
Chemical Synthesis ◽  
State Of The Art ◽  
Optically Active ◽  
Considerable Progress ◽  
Future Prospects ◽  
Chiral Compound ◽  
Biological Production ◽  
Acetoin Production ◽  
Made In

Acetoin is an important four-carbon compound that has many applications in foods, chemical synthesis, cosmetics, cigarettes, soaps, and detergents. Its stereoisomer (S)-acetoin, a high-value chiral compound, can also be used to synthesize optically active drugs, which could enhance targeting properties and reduce side effects. Recently, considerable progress has been made in the development of biotechnological routes for (S)-acetoin production. In this review, various strategies for biological (S)- acetoin production are summarized, and their constraints and possible solutions are described. Furthermore, future prospects of biological production of (S)-acetoin are discussed.

Digital Technology in Clinical Trials for Multiple Sclerosis: a systematic review. (Preprint)

2020 ◽  
Author(s):  
Marcello De Angelis ◽  
Luigi Lavorgna ◽  
Antonio Carotenuto ◽  
Martina Petruzzo ◽  
Roberta Lanzillo ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Digital Technology ◽  
Clinical Trial Design ◽  
Motor Rehabilitation ◽  
Robot Assisted ◽  
Future Directions ◽  
Treatment Side Effects

BACKGROUND Clinical trials in multiple sclerosis (MS) have leveraged the use of digital technology to overcome limitations in treatment and disease monitoring. OBJECTIVE To review the use of digital technology in concluded and ongoing MS clinical trials. METHODS In March 2020, we searched for “multiple sclerosis” and “trial” on pubmed.gov and clinicaltrials.gov using “app”, “digital”, “electronic”, “internet” and “mobile” as additional search words, separately. Overall, we included thirty-five studies. RESULTS Digital technology is part of clinical trial interventions to deliver psychotherapy and motor rehabilitation, with exergames, e-training, and robot-assisted exercises. Also, digital technology has become increasingly used to standardise previously existing outcome measures, with automatic acquisitions, reduced inconsistencies, and improved detection of symptoms. Some trials have been developing new patient-centred outcome measures for the detection of symptoms and of treatment side effects and adherence. CONCLUSIONS We will discuss how digital technology has been changing MS clinical trial design, and possible future directions for MS and neurology research.

scholarly journals Improving pragmatic clinical trial design using real-world data

2019 ◽  
Vol 16 (3) ◽  
pp. 273-282 ◽  
Author(s):  
Susan M Shortreed ◽  
Carolyn M Rutter ◽  
Andrea J Cook ◽  
Gregory E Simon
Keyword(s):  
Clinical Trials ◽  
Trial Design ◽  
Suicide Attempts ◽  
Real World Data ◽  
Electronic Health Record Data ◽  
Pragmatic Clinical Trial ◽  
Pragmatic Clinical Trials ◽  
Sample Size Calculations ◽  
Record Data ◽  
Electronic Health

Background Pragmatic clinical trials often use automated data sources such as electronic health records, claims, or registries to identify eligible individuals and collect outcome information. A specific advantage that this automated data collection often yields is having data on potential participants when design decisions are being made. We outline how this data can be used to inform trial design. Methods Our work is motivated by a pragmatic clinical trial evaluating the impact of suicide-prevention outreach interventions on fatal and non-fatal suicide attempts in the 18 months after randomization. We illustrate our recommended approaches for designing pragmatic clinical trials using historical data from the health systems participating in this study. Specifically, we illustrate how electronic health record data can be used to inform the selection of trial eligibility requirements, to estimate the distribution of participant characteristics over the course of the trial, and to conduct power and sample size calculations. Results Data from 122,873 people with patient health questionnaire (PHQ) responses, recorded in their electronic health records between 1 July 2010 and 31 March 2012, were used to show that the suicide attempt rate in the 18 months following completion of the questionnaire varies by response to item nine of the PHQ. We estimated that the proportion of individuals with a prior recorded elevated PHQ (i.e. history of suicidal ideation) would decrease from approximately 50% at the beginning of a trial to about 5%, 50 weeks later. Using electronic health record data, we conducted simulations to estimate the power to detect a 25% reduction in suicide attempts. Simulation-based power calculations estimated that randomizing 8000 participants per randomization arm would allow 90% power to detect a 25% reduction in the suicide attempt rate in the intervention arm compared to usual care at an alpha rate of 0.05. Conclusions Historical data can be used to inform the design of pragmatic clinical trials, a strength of trials that use automated data collection for randomizing participants and assessing outcomes. In particular, realistic sample size calculations can be conducted using real-world data from the health systems in which the trial will be conducted. Data-informed trial design should yield more realistic estimates of statistical power and maximize efficiency of trial recruitment.

The Use of Methotrexate in Rheumatoid Arthritis

1985 ◽  
Vol 19 (5) ◽  
pp. 349-358 ◽  
Author(s):  
Peter W. Letendre ◽  
Douglas J. DeJong ◽  
Donald R. Miller
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Folic Acid ◽  
Side Effects ◽  
Adverse Effects ◽  
Systemic Administration ◽  
Refractory Disease ◽  
Controlled Clinical Trials ◽  
Folic Acid Antagonist ◽  
Acid Antagonist

The use of methotrexate in rheumatoid arthritis is reviewed. Methotrexate, a folic acid antagonist, is sometimes employed in an attempt to symptomatically control patients whose disease does not respond adequately to conventional therapies. Systemic administration of 7.5–15 mg/wk in a “pulse” fashion appears to be effective without precipitating severe adverse effects. However, concern over potentially serious side effects and a lack of well-controlled clinical trials have limited its use to severe, refractory disease. Further studies are needed before its role in rheumatoid arthritis can justifiably be expanded.

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