Prevalence of control groups in cardiovascular clinical trials: An analysis of ClinicalTrials.gov from 2009 through 2019

2021 ◽  
Author(s):  
Alexander R. Zheutlin ◽  
David J. Caldwell ◽  
Jad Al Danaf ◽  
Rashmee U. Shah
Keyword(s):  
Clinical Trials ◽  
Control Groups

scholarly journals Effect of photobiomodulation in secondary intention gingival wound healing—a systematic review and meta-analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Pooya Ebrahimi ◽  
Mahdi Hadilou ◽  
Ferdos Naserneysari ◽  
Amirmohammad Dolatabadi ◽  
Rana Tarzemany ◽  
...  
Keyword(s):  
Systematic Review ◽  
Wound Healing ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Healing Process ◽  
Adjunctive Treatment ◽  
Control Groups ◽  
Secondary Intention ◽  
Post Operative Pain

Abstract Background Photobiomodulation is widely being used to improve the wound healing process in dentistry and a vast majority of studies have proven its benefits. But there are plenty of knowledge gaps according to the optimal laser characteristics which should be used to maximize the healing effects of lasers. The goal of this systematic review and meta-analysis was to determine the effect of photobiomodulation (PBM) as an adjunctive treatment to periodontal therapies to evaluate secondary intention gingival wound healing and post-operative pain. Methods Five databases (PubMed, Embase, Scopus, ProQuest, and Web of Sciences) were searched up to November 30, 2020, for clinical trials that reported the result of the application of PBM on secondary gingival healing wounds and post-operative pain and discomfort after periodontal surgeries. Two independent reviewers selected the eligible studies and the outcomes of interest were extracted. The quality of eligible studies was assessed using the Cochrane Handbook for Systematic Reviews of Interventions. Results Ultimately, twelve studies were included in this review. The application of PBM as an adjunct to periodontal surgeries resulted in a significant improvement in wound healing indices. The Landry wound healing index at the 7th post-operative day was significantly improved (SMD = 1.044 [95% CI 0.62–1.46]; p < 0.01) in PBM + surgery groups compared to the control groups. There was also a statistically significant increase in the complete wound epithelialization (RR = 3.23 [95% CI 1.66–6.31]; p < 0.01) at the 14th post-operative day compared to the control groups. The methods used to assess the post-operative pain were heterogeneous, and therefore the results were limited which made the meta-analysis for post-operative pain assessment not possible. Conclusion Based on the results of this review, PBM can be effectively used as a method to improve secondary intention wound healing. High-quality randomized clinical trials, however, are needed in the future to identify the optimal PBM irradiation parameters and the effect of PBM on post-operative pain.

scholarly journals 1592. Antimicrobial Activity of Ceftazidime-Avibactam and Comparator Agents Against Enterobacterales and Pseudomonas aeruginosa With Overexpression of AmpC β-Lactamase From Phase 3 Clinical Trials

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S792-S793
Author(s):  
Lynn-Yao Lin ◽  
Dmitri Debabov ◽  
William Chang ◽  
Urania Rappo
Keyword(s):  
Clinical Trials ◽  
Active Agent ◽  
Complicated Urinary Tract Infection ◽  
Carbapenem Resistance ◽  
Vitro Activity ◽  
In Vitro Activity ◽  
Control Groups ◽  
In Vitro Susceptibility ◽  
Intra Abdominal Infection

Abstract Background AmpC overproduction is a main mechanism of carbapenem resistance, in the absence of acquired carbapenemases. Ceftazidime-avibactam (CAZ-AVI) has potent in vitro activity against AmpC-producing P. aeruginosa and Enterobacterales that are resistant to carbapenems and other β-lactams. Methods Activity of CAZ-AVI and comparators was evaluated against AmpC-overproducing Enterobacterales (n=77) and P. aeruginosa (n=53) collected from 4 CAZ-AVI clinical trials: RECLAIM (complicated intra-abdominal infection [cIAI]), REPRISE (cIAI/complicated urinary tract infection [cUTI]), RECAPTURE (cUTI) and REPROVE (hospital-acquired pneumonia/ventilator associated pneumonia). In vitro susceptibility of CAZ-AVI and comparators was performed by broth microdilution using ThermoFisher custom panels. CLSI breakpoints were used to determine susceptibility. Quantitative PCR and microarray data were used to characterize presence and expression of AmpC. Clinical response at test of cure was assessed. Results Against 77 AmpC-overproducing Enterobacterales isolates, meropenem-vaborbactam (MVB) (98.7% susceptible [S]), CAZ-AVI (96.1% S), and meropenem (MEM) (96.1% S) had similar in vitro activity (Table), with greater in vitro activity than amikacin (AMK) (84.4% S), gentamicin (61.0% S), and ceftolozane-tazobactam (TZC) (35.1% S). Clinical cures in patients with baseline AmpC-overproducing Enterobacterales were 21/26 (81%) in CAZ-AVI group vs 17/20 (85%) in control groups. Against 53 AmpC-overproducing P. aeruginosa isolates, CAZ-AVI (73.6% S) showed greater in vitro activity than AMK (69.8% S), TZC (58.5% S), and MEM (37.7% S). Clinical cures in patients with baseline AmpC-overproducing P. aeruginosa were 12/14 (86%) in CAZ-AVI group vs 9/12 (75%) in control groups. MIC distributions against the same P aeruginosa isolates were CAZ-AVI (MIC50/90, 4/ &gt;64 µg/mL), MVB (MIC50/90, 8/32 µg/mL), and MEM (MIC50/90, 8/32 µg/mL). Table Conclusion CAZ-AVI was the most active agent against AmpC-overproducing P. aeruginosa with higher proportion of clinical cure than controls. CAZ-AVI was also among the most active agents against AmpC-overproducing Enterobacterales, with &gt;96% isolates susceptible. Disclosures Lynn-Yao Lin, MS, AbbVie (Employee) Dmitri Debabov, PhD, AbbVie (Employee) William Chang, BS, AbbVie (Employee) Urania Rappo, MD, MS, PharmD, Allergan (before its acquisition by AbbVie) (Employee)

Oral contraceptives and psychological symptoms

1969 ◽  
Vol 7 (1) ◽  
pp. 2-4
Keyword(s):  
Clinical Trials ◽  
Oral Contraceptives ◽  
Psychological Symptoms ◽  
Good Evidence ◽  
Reliable Data ◽  
Intermediary Metabolism ◽  
Control Groups ◽  
Cerebral Activity ◽  
The Brain

Psychological symptoms are notoriously difficult to assess, and it is not surprising that the reported incidence of such symptoms in women taking oral contraceptives varies widely. The apparent incidence may further be influenced by what the subjects think they are expected to say. Clinical trials of oral contraceptives where psychological symptoms have been specifically studied provide the most reliable data, but control groups have so far been examined in only a few trials. Data on such symptoms from trials where unwanted effects were merely noted in passing are unreliable. There is however good evidence that synthetic progestagens influence cerebral activity1–3 and intermediary metabolism in the brain4 in both women and animals and that these effects do not mimic those of pregnancy.

Dexamethasone in Patients with Spontaneous Intracerebral Hemorrhage: An Updated Meta-Analysis

2020 ◽  
Vol 49 (5) ◽  
pp. 495-502
Author(s):  
Stephanie Wintzer ◽  
Josef Georg Heckmann ◽  
Hagen B. Huttner ◽  
Stefan Schwab
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Intracerebral Hemorrhage ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Spontaneous Intracerebral Hemorrhage ◽  
Control Groups ◽  
Language Data ◽  
Negative Effect

<b><i>Background:</i></b> Spontaneous intracerebral hemorrhage (ICH) is a frequent cerebrovascular disorder and still associated with high mortality and poor clinical outcomes. The purpose of this review was to update a 15-year-old former meta-analysis on randomized clinical trials (RCTs) addressing the question of whether ICH patients treated with dexamethasone have better outcomes than controls. <b><i>Methods:</i></b> The electronic databases PubMed, SCOPUS, and Cochrane as well as web platforms on current clinical trials were searched for the years 1970–2020 without constriction on language. Data were extracted and outcomes were pooled for conventional and cumulative meta-analysis using a commercial software program (www.Meta-Analysis.com). <b><i>Results:</i></b> Finally, 7 RCTs were identified and analyzed including 248 participants in the dexamethasone groups and 242 in the control groups. Five studies showed a high risk of bias. The overall relative risk (RR) for death was 1.32 (95% confidence interval [CI] 0.99–1.76; <i>p</i> = 0.06) and did not differ significantly between the 2 groups. After exclusion of studies with high risk of bias, the RR for death was 1.37 (95% CI 0.54–3.42; <i>p</i> = 0.51). The RR for poor outcome did not differ significantly between the 2 groups analyzed for all included studies (RR = 0.69; 95% CI 0.47–1; <i>p</i> = 0.05) and after exclusion of studies with high risk of bias (RR = 0.7; 95% CI 0.45–1.08; <i>p</i> = 0.11). The RR for complications did not differ significantly including all studies (RR = 1.29; 95% CI 0.77–2.17; <i>p</i> = 0.34) and after exclusion of studies with high risk of bias (RR = 1.27; 95% CI 0.18–8.89; <i>p</i> = 0.81). The cumulative statistics delivered no other results; however, it pointed out fewer complications over time in the dexamethasone group. <b><i>Conclusion:</i></b> Clear evidence of a beneficial or negative effect of dexamethasone is still lacking. Modern RCTs or observational studies with propensity design are necessary to evaluate the efficacy and safety of treatment with dexamethasone in patients with ICH.

scholarly journals Extraction of primary canines for interceptive orthodontic treatment of palatally displaced permanent canines: A systematic review

2017 ◽  
Vol 87 (6) ◽  
pp. 878-885 ◽  
Author(s):  
Naif N. Almasoud
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Web Of Science ◽  
Quality Criteria ◽  
Control Groups ◽  
Exclusion Criteria ◽  
The University ◽  
Study Designs ◽  
Primary Canine

ABSTRACT Objective: To determine whether the successful management of palatally displaced permanent canines (PDCs) can be achieved by the interceptive extraction of primary maxillary canines. Materials and Methods: Digital databases (Medline, Scopus, Web of Science, and Cochrane) were searched to retrieve articles published from 1952 to April 2016. The university librarian developed search strategies for each database. Two calibrated reviewers independently reviewed potentially related titles and abstracts. Papers meeting the inclusion and exclusion criteria were read in full. The selected articles were evaluated and scored according to methodological quality criteria. Results: Four randomized clinical trials (RCTs) were included in the systematic review. Compared with two older studies, two more recent RCTs were found to have better study designs, were better conducted, and involved better reporting of the results. The included studies compared intervention groups (children with PDCs undergoing extraction of primary canines) with controls (subjects with PDCs but no primary canine extractions). In three of the four studies, the interceptive extraction of primary canines facilitated eruption of PDCs in more than 65% of cases. Overall, the intervention groups had a markedly higher incidence of successful eruption of PDCs (50%–69%) compared with the control groups (36%–42%). Conclusions: Based on the available evidence, it is reasonable to conclude that eruption of PDCs can be facilitated by extraction of primary canines. However, further high-quality, randomized clinical trials are warranted in other population groups. It is hoped that this study will help orthodontists make evidence-based decisions about clinically managing PDCs.

Trials and Tribulations

1959 ◽  
Vol 105 (441) ◽  
pp. 1082-1087 ◽  
Author(s):  
A. A. Baker ◽  
J. G. Thorpe
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Positive Result ◽  
New Method ◽  
Medical Statistics ◽  
Control Groups ◽  
Therapeutic Success ◽  
Sixth Edition ◽  
Bradford Hill ◽  
Physical Therapies

With the advent of effective physical therapies, psychiatrists have become increasingly interested in the problems posed by clinical trials. Professor Bradford Hill, in the Preface to the Sixth Edition of his Principles of Medical Statistics (1) noted that “… passage of time has … brought clinical trials into prominence and fashion …”. More recently Professor Pickering has described the clinical trial as “the most important new method introduced into clinical science in recent years” (2). Some interesting differences between controlled and uncontrolled trials are well brought out in the paper by Foulds (3) in which he found that therapeutic success was claimed in 85 per cent. of studies not using control groups. Among those studies using control groups, however, only 25 per cent. obtained a positive result. He concluded that “claims for the success of a treatment are closely associated with absence of the means whereby these claims can be scientifically substantiated”.

scholarly journals Unethical informed consent caused by overlooking poorly measured nocebo effects

2020 ◽  
pp. medethics-2019-105903
Author(s):  
Jeremy Howick
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Natural History ◽  
Adverse Events ◽  
Placebo Effect ◽  
Nocebo Effect ◽  
Control Groups ◽  
Nocebo Effects ◽  
Negative Outcome

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients.

scholarly journals Immediate Rescue Designs in Pediatric Analgesic Trials

2015 ◽  
Vol 122 (1) ◽  
pp. 150-171 ◽  
Author(s):  
Joe Kossowsky ◽  
Carolina Donado ◽  
Charles B. Berde
Keyword(s):  
Clinical Trials ◽  
Rescue Medication ◽  
Study Groups ◽  
Cochrane Library ◽  
Future Research ◽  
Control Groups ◽  
Antiinflammatory Drugs ◽  
Assay Sensitivity ◽  
Pain Scores ◽  
Opioid Sparing

Abstract Background: Designing analgesic clinical trials in pediatrics requires a balance between scientific, ethical, and practical concerns. A previous consensus group recommended immediate rescue designs using opioid sparing as a surrogate measure of analgesic efficacy. The authors summarize the performance of rescue analgesic designs in pediatric trials of four commonly used classes of analgesics: opioids, nonsteroidal antiinflammatory drugs, acetaminophen, and local anesthetics. Methods: MEDLINE, Embase, CINAHL, The Cochrane Library, and Web of science were searched in April 2013. The 85 studies selected were randomized or controlled clinical trials using immediate rescue paradigms in postoperative pain settings. A random-effects meta-analysis was used to synthesize predefined outcomes using Hedges’ g. Difference between the means of the treatment arms were also expressed as a percentage of the corresponding value in the placebo group (placebo-treatment/placebo). Distributions of pain scores in study and control groups and relationships between opioid sparing and pain scores were examined. Results: For each of the four study drug classes, significant opioid sparing was demonstrated in a majority of studies by one or more of the following endpoints: (1) total dose (milligram per kilogram per hour), (2) percentage of children requiring rescue medication, and (3) time to first rescue medication (minutes). Pain scores averaged 2.4/10 in study groups, 3.4/10 in control groups. Conclusions: Opioid sparing is a feasible pragmatic endpoint for pediatric pain analgesic trials. This review serves to guide future research in pediatric analgesia trials, which could test whether some specific design features may improve assay sensitivity while minimizing the risk of unrelieved pain.

scholarly journals Effects of walnut consumption on blood lipids and other cardiovascular risk factors: an updated meta-analysis and systematic review of controlled trials

2018 ◽  
Vol 108 (1) ◽  
pp. 174-187 ◽  
Author(s):  
Marta Guasch-Ferré ◽  
Jun Li ◽  
Frank B Hu ◽  
Jordi Salas-Salvadó ◽  
Deirdre K Tobias
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Body Weight ◽  
Cardiovascular Risk ◽  
Blood Lipids ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Control Groups

ABSTRACT BACKGROUND Intervention studies suggest that incorporating walnuts into the diet may improve blood lipids without promoting weight gain. OBJECTIVE We conducted a systematic review and meta-analysis of controlled trials evaluating the effects of walnut consumption on blood lipids and other cardiovascular risk factors. Design We conducted a comprehensive search of PubMed and EMBASE databases (from database inception to January 2018) of clinical trials comparing walnut-enriched diets with control diets. We performed random-effects meta-analyses comparing walnut-enriched and control diets for changes in pre-post intervention in blood lipids (mmol/L), apolipoproteins (mg/dL), body weight (kg), and blood pressure (mm Hg). RESULTS Twenty-six clinical trials with a total of 1059 participants were included. The following weighted mean differences (WMDs) in reductions were obtained for walnut-enriched diets compared with control groups: −6.99 mg/dL (95% CI: −9.39, −4.58 mg/dL; P < 0.001) (3.25% greater reduction) for total blood cholesterol (TC) and −5.51 mg/dL (95% CI: −7.72, −3.29 mg/dL; P < 0.001) (3.73% greater reduction) for low-density lipoprotein (LDL) cholesterol. Triglyceride concentrations were also reduced in walnut-enriched diets compared with control [WMD = −4.69 (95% CI: −8.93, −0.45); P = 0.03; 5.52% greater reduction]. More pronounced reductions in blood lipids were observed when walnut interventions were compared with American and Western diets [WMD for TC = −12.30 (95% CI: −23.17, −1.43) and for LDL = −8.28 (95% CI: −13.04, −3.51); P < 0.001]. Apolipoprotein B (mg/dL) was also reduced significantly more on walnut-enriched diets compared with control groups [WMD = −3.74 (95% CI: −6.51, −0.97); P = 0.008] and a trend towards a reduction was observed for apolipoprotein A [WMD = −2.91 (95% CI: −5.98, 0.08); P = 0.057]. Walnut-enriched diets did not lead to significant differences in weight change (kg) compared with control diets [WMD = −0.12 (95% CI: −2.12, 1.88); P = 0.90], systolic blood pressure (mm Hg) [WMD = −0.72 (95% CI: −2.75, 1.30); P = 0.48], or diastolic blood pressure (mm Hg) [WMD = −0.10 (95% CI: −1.49, 1.30); P = 0.88]. Conclusions Incorporating walnuts into the diet improved blood lipid profile without adversely affecting body weight or blood pressure.

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