The Safety and Efficacy of AlphaWave ® L-Theanine on Adults Who Experience Moderate Stress on a Regular Basis
Condition:   Stress Interventions:   Dietary Supplement: AlphaWave® L-Theanine;   Other: Placebo Sponsors:   Ethical Naturals, Inc.;   KGK Science Inc. Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 11, 2023 Category: Research Source Type: clinical trials

Unicompartmental knee arthroplasty vs. high tibial osteotomy for medial knee osteoarthritis (UNIKORN): a study protocol of a randomized controlled trial
AbstractBackgroundMedial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients ’ physical activity. After failed conservative treatment, unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are possible surgical treatment options for this condition. There is a paucity of high-quality evidence in the literature comparing objective and subjective outcomes o f these procedures. Also, there is no common agreement on whether these procedures provide comparable results in late-stage medial knee OA patients.MethodsWe will perform a prospective randomized controlled ...
Source: Trials - April 5, 2023 Category: Research Source Type: clinical trials

Individual psychotherapy for cluster-C personality disorders: protocol of a pragmatic RCT comparing short-term psychodynamic supportive psychotherapy, affect phobia therapy and schema therapy (I-FORCE)
In this study, we will compare the differential (cost)-effectiveness of three individual psychotherapies: short-term psychodynamic supportive psychotherapy (SPSP), affect phobia therapy (APT) and schema therapy (ST). Although these psychotherapies are commonly used in clinical practice, evidence for the Cluster-C PDs is limited. Additionally, we will investigate predictive factors, non-specific and therapy-specific mediators.MethodsThis is a mono-centre randomized clinical trial with three parallel groups: (1) SPSP, (2) APT, (3) ST. Randomization on patient level will be pre-stratified according to type of PD. The total st...
Source: Trials - April 5, 2023 Category: Research Source Type: clinical trials

Changing patient preferences toward better trial recruitment: an ethical analysis
AbstractWhile randomized controlled trials are essential to health research, many of these trials fail to recruit enough participants. Approaching recruitment through the lens of behavioral science can help trialists to understand influences on the decision to participate and use them to increase recruitment. Although this approach is promising, the use of behavioral influences during recruitment is in tension with the ethical principle of respect for persons, as at least some of these influences could be used to manipulate potential participants. In this paper, we examine this tension by discussing two types of behavioral...
Source: Trials - March 28, 2023 Category: Research Source Type: clinical trials

The relationship between different bispectral index and the occurrence of dreams in elective surgery under general anesthesia: protocol for a randomized controlled clinical trial
AbstractIntroductionDreaming reported after anesthesia remains a poorly understood phenomenon. At present, there is a hypothesis that dreaming occurs intraoperatively and is related to light or inadequate anesthesia; thus, in order to further verify the hypothesis, we choose elective surgery under general anesthesia to observe whether the generation of dreams is related to the dose of general anesthetics maintenance.Methods and analysisThis randomized, double-blind controlled trial to observe whether the generation of dreams is related to the dose of general anesthetics maintenance in the elective surgery under general ane...
Source: Trials - March 20, 2023 Category: Research Source Type: clinical trials

What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics
ConclusionThere is significant variation in definitions of equipoise offered by respondents, suggesting that parties within groups and between groups may be referring to different concepts when they reference “equipoise”. This non-uniformity may impact fairness and transparency and opens the door to potential ethical problems in the evaluation of clinical trials — for instance, a patient may understand equipoise very differently than the researchers enrolling her in a trial, which could cause her a greement to participate to be based upon false premises. (Source: Trials)
Source: Trials - March 18, 2023 Category: Research Source Type: clinical trials

(DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU.
Conditions:   Cessation of Treatment;   End of Life Intervention:   Other: observational Sponsor:   Société Française d'Anesthésie et de Réanimation Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 15, 2023 Category: Research Source Type: clinical trials