Search results for "clinical trials"

Cell therapy of periodontium: from animal to human?

2013

Periodontitis is a chronic inflammatory disease affecting the soft and hard tissues supporting the teeth, which often leads to tooth loss. Its significant impact on the patient's general health and quality of life point to a need for more effective management of this condition. Existing treatments include scaling/root planning and surgical approaches but their overall effects are relatively modest and restricted in application. The goal of regenerative therapy of periodontal defects is to enhance endogenous progenitors and thus promote optimal wound healing. Considering that the host or tissue might be defective in the periodontitis context, it has been proposed that grafting exogenous stem…

Recent advances on HIV DNA vaccines development: Stepwise improvements to clinical trials.

2019

According to WHO (World Health Organization) reports, more than 770,000 people died from HIV and almost 1.7 million people becoming newly infected in the worldwide in 2018. Therefore, many attempts should be done to produce a forceful vaccine to control the AIDS. DNA-based vaccines have been investigated for HIV vaccination by researches during the recent 20 years. The DNA vaccines are novel approach for induction of both type of immune responses (cellular and humoral) in the host cells and have many advantages including high stability, fast and easy of fabrication and absence of severe side effects when compared with other vaccination methods. Recent studies have been focused on vaccine de…

Oral trasmucosal fentanyl citrate for breakthrough pain treatment in cancer patients.

2012

Breakthrough cancer pain has been defined as a transitory increase in pain intensity that occurs either spontaneously or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain. The availability of supplemental doses of oral opioids, in addition to the continuous analgesic medication, is the main treatment suggested to manage pain flares.Oral transmucosal fentanyl citrate (OTFC) is the first product of a new generation of delivery systems, named rapid-onset opioids (ROOs), characterized by rapidity of effect and the short duration of analgesia. Controlled studies and long-term experience have shown that OTFC is an e…

Two-stage adaptive designs with correlated test statistics.

2005

When performing a trial using an adaptive sequential design, it is usually assumed that the data for each stage come from different units; for example, patients. However, sometimes it is not possible to satisfy this condition or to check whether it is satisfied. In these cases, the test statistics and p-values of each stage may be dependent. In this paper we investigate the type I error of two-stage adaptive designs when the test statistics from the stages are assumed to be bivariate normal. Analytical considerations are performed under the restriction that the conditional error function is constant in the continuation region. We show that the decisions can become conservative as well as an…

Strategies for Including Patients Recruited During Interim Analysis of Clinical Trials

2007

In clinical trials a periodical check of safety and efficacy data is often needed. For organizational reasons it is rarely desirable to stop a trial during such an interim analysis. Therefore, new study patients are included in the trial while the interim analysis is ongoing. Disregarding the additional information provided by these interim patients would be unsatisfactory, especially for an office of regulatory affairs. Consequently, the rules for group sequential or adaptive decisions must be adjusted to the recruitment of interim patients. In this paper, two strategies for modifying study designs to consider the analysis of interim patients are proposed.

Cinnamomum Species: Bridging Phytochemistry Knowledge, Pharmacological Properties and Toxicological Safety for Health Benefits

2021

The genus Cinnamomum includes a number of plant species largely used as food, food additives and spices for a long time. Different traditional healing systems have used these plants as herbal remedies to cure diverse ailments. The aim of this comprehensive and updated review is to summarize the biodiversity of the genus Cinnamomum, its bioactive compounds, the mechanisms that underlie the pharmacological activities and molecular targets and toxicological safety. All the data in this review have been collected from databases and recent scientific literature including Web of Science, PubMed, ScienceDirect etc. The results showed that the bioactive compounds of Cinnamomum species possess antim…

Effectiveness of lifestyle interventions in NAFLD (nonalcoholic fatty liver disease) - how are clinical trials affected?

2020

Methodological Problems in RCTs on IBD

2012

Abstract: Randomized controlled trials (RCTs) are the gold standard method for developing evidence-based medicine in inflammatory bowel disease (IBD). Methodological problems in RCTs in IBD concern different aspects such as the definition of the study population due to the extreme variability of patients with IBD, the indices of disease activity, a clearly defined outcome, the environmental risk factors (i.e smoking behaviour) that may influence the randomization, the heterogeneous placebo rate of remission and the different statistical methods used to analyze the results. It is important that trials are designed efficiently, done well and complement clinical practice with a careful subject…

Evaluation of the effectiveness of the photobiomodulation in the treatment of dentin hypersensitivity after basic therapy. A randomized clinical trial

2016

Background: Dentin hypersensitivity (DH) in one of the most common causes of patient discomfort in the general population and its prevalence is higher in patients who have received basic or surgical periodontal treatment. Efficiency of the diode laser with different wavelengths has been studied by several authors, showing an improvement rate of the DH between 60-98%. The aim of the present study was to evaluate the effect of photobiomodulation (PBM) treatment on the reduction of DH after non surgical periodontal treatment. Material and methods: A randomized split mouth clinical trial was performed involving 30 patients (120 teeth) diagnosed with DH after scaling and root planning. Two teeth…

Antibiotic prophylaxis in antenatal nonrefluxing hydronephrosis, megaureter and ureterocele

2012

Observation is a conservative management option in infants with nonrefluxing hydronephrosis, primary nonrefluxing megaureter and ureterocele diagnosed postnatally following antenatal detection of hydronephrosis. Antibiotic prophylaxis might be a sensible regimen under these circumstances to prevent UTI in this population who are potentially at increased risk. However, studies examining the efficacy of prophylactic antibiotics are sparse in this setting. For each condition, prophylactic policies seem extremely variable, and UTI rates vary widely with comparable rates reported between patients followed on and off antibiotics. Overall, antibiotic prophylaxis seems unnecessary in patients with …