Sustainable, healthy cities: protocol of a mixed methods evaluation of a cluster randomized controlled trial for Aedes control in Brazil using a community mobilization approach
Dengue is increasing in its global presence with an estimated 4 billion people at-risk of infection in at least 128 countries. Despite the promising results of EcoHealth and community mobilization approaches to A... (Source: Trials)
Source: Trials - February 14, 2020 Category: General Medicine Authors: Kate Zinszer, Andrea Caprara, Antonio Lima, St éphanie Degroote, Monica Zahreddine, Kellyanne Abreu, Mabel Carabali, Katia Charland, Mayana Azevedo Dantas, José Wellington, Beatriz Parra, Florence Fournet, Emmanuel Bonnet, Denis Pérez, Emilie Robert, C Tags: Study protocol Source Type: research

The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a treatment for traumatized young refugees versus treatment as usual: study protocol for a multi-center randomized controlled trial (YOURTREAT)
Germany hosts a large number of refugees from war-affected countries. The integration of refugees, in particular young refugees from the Middle East, is one of the major current social challenges in Germany. M... (Source: Trials)
Source: Trials - February 14, 2020 Category: General Medicine Authors: Sarah Wilker, Claudia Catani, Jasmin Wittmann, Melissa Preusse, Telja Schmidt, Theodor May, Verena Ertl, Bettina Doering, Rita Rosner, Areej Zindler and Frank Neuner Tags: Study protocol Source Type: research

Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial
Mexico has one of the highest prevalence rates of obesity worldwide. New pharmacological strategies that focus on people with class III obesity are required. Metformin and dapagliflozin are two drugs approved ... (Source: Trials)
Source: Trials - February 14, 2020 Category: General Medicine Authors: Aldo Ferreira-Hermosillo, Mario Antonio Molina-Ayala, Diana Molina-Guerrero, Ana Pamela Garrido-Mendoza, Claudia Ram írez-Rentería, Victoria Mendoza-Zubieta, Etual Espinosa and Moisés Mercado Tags: Study protocol Source Type: research

Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess the trustworthiness of claims about treatment effects: one-year follow up of a randomised trial
Earlier, we designed and evaluated an educational mass media intervention for improving people ’s ability to think more critically and to assess the trustworthiness of claims (assertions) about the benefits and... (Source: Trials)
Source: Trials - February 14, 2020 Category: General Medicine Authors: Daniel Semakula, Allen Nsangi, Andrew D. Oxman, Matt Oxman, Astrid Austvoll-Dahlgren, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Laetitia Nyirazinyoye, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Christopher J. Rose and Nelson K. Sew Tags: Research Source Type: research

Identifying treatment effects of an informal caregiver education intervention to increase days in the community and decrease caregiver distress: a machine-learning secondary analysis of subgroup effects in the HI-FIVES randomized clinical trial
Informal caregivers report substantial burden and depressive symptoms which predict higher rates of patient institutionalization. While caregiver education interventions may reduce caregiver distress and decre... (Source: Trials)
Source: Trials - February 14, 2020 Category: General Medicine Authors: Megan Shepherd-Banigan, Valerie A. Smith, Jennifer H. Lindquist, Michael Paul Cary Jr., Katherine E. M. Miller, Jennifer G. Chapman and Courtney H. Van Houtven Tags: Research Source Type: research

Addition of proprioceptive neuromuscular facilitation to cardiorespiratory training in patients poststroke: study protocol for a randomized controlled trial
DiscussionThe association of PNF with CRT may be a viable and accessible alternative to increase cardiorespiratory function in patients with stroke.Trial registrationClinicalTrials.gov,NCT03171012. Registered on 6 June 2017. (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Use of cannabinoid-based medicine among older residential care recipients diagnosed with dementia: study protocol for a double-blind randomised crossover trial
DiscussionThe study design has been informed by medical professionals and key stakeholders, including those working in the residential aged-care industry to ensure patient safety, collection of non-invasive measures, and methodological rigor and study feasibility.Trial registrationAustralian New Zealand Clinical Trials Registry,ACTRN12619000474156. Registered on 21 March 2019 (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial
AbstractBackgroundEighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smo...
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial
DiscussionForty-six percent of the patients in our Obesity Clinic have been diagnosed with prediabetes (32%) or diabetes (14%). The use of dapagliflozin in this population could improve weight loss and other cardiovascular factors. This effect could be translated into less time before undergoing bariatric surgery and better control of associated comorbidities.Trial registrationClinicaltrials.gov, ID:NCT03968224. Retrospectively registered on May 29, 2019. (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a treatment for traumatized young refugees versus treatment as usual: study protocol for a multi-center randomized controlled trial (YOURTREAT)
DiscussionThe results of this study should provide evidence regarding effective treatment options for young refugees in Germany, a population that has been understudied and received only limited access to mental health care so far. Next to the effects of treatment on mental health outcomes, integration parameters will be investigated. Therefore, this study should provide broad insights into treatment options for young refugees and their potential implications on successful integration.Trial registrationGerman Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS), ID:DRKS00017222. Registered on 15 May 2019. (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Sustainable, healthy cities: protocol of a mixed methods evaluation of a cluster randomized controlled trial for Aedes control in Brazil using a community mobilization approach
DiscussionThe results of our study will provide evidence on community mobilization as an intervention for dengue control. We anticipate that if community mobilization is effective in Fortaleza, the results of this study will help develop evidence-based vector control programs in Brazil, and also in other countries struggling withAedes-transmitted diseases.Trial registrationISRCTN66131315, registration date: 1 October 2018. (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Identifying treatment effects of an informal caregiver education intervention to increase days in the community and decrease caregiver distress: a machine-learning secondary analysis of subgroup effects in the HI-FIVES randomized clinical trial
AbstractBackgroundInformal caregivers report substantial burden and depressive symptoms which predict higher rates of patient institutionalization. While caregiver education interventions may reduce caregiver distress and decrease the use of long-term institutional care, evidence is mixed. Inconsistent findings across studies may be the result of reporting average treatment effects which do not account for how effects differ by participant characteristics. We apply a machine-learning approach to randomized clinical trial (RCT) data of theHelping Invested Family Members Improve Veteran ’s Experiences Study (HI-FIVES) ...
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess the trustworthiness of claims about treatment effects: one-year follow up of a randomised trial
ConclusionsAlthough listening to the Informed Health Choices podcast initially led to a large improvement in the ability of parents to assess claims about the effects of treatments, our findings show that these skills decreased substantially over 1 year. More active practice could address the substantial skills decay observed over 1 year.Trial registrationPan African Clinical Trial Registry (www.pactr.org),PACTR201606001676150. Registered on 12 June 2016. (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial
Medication is generally recommended to reduce the morbidity and mortality caused by cardiovascular disease in hypertensive patients. However, considering the difficulties and economic factors associated with l... (Source: Trials)
Source: Trials - February 13, 2020 Category: General Medicine Authors: Sang-Hyun Lee, Byung-Jun Kim, In-Hwa Park, Eui-Hyoung Hwang, Eun Ju Park, Insoo Jang and Man-Suk Hwang Tags: Study protocol Source Type: research

Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial
The population of adult patients with early-treated phenylketonuria (PKU) following newborn screening is growing substantially. The ideal target range of blood phenylalanine (Phe) levels in adults outside preg... (Source: Trials)
Source: Trials - February 13, 2020 Category: General Medicine Authors: Roman Trepp, Raphaela Muri, Stephanie Abgottspon, Lenka Bosanska, Michel Hochuli, Johannes Slotboom, Christian Rummel, Roland Kreis and Regula Everts Tags: Study protocol Source Type: research

Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction
Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasti... (Source: Trials)
Source: Trials - February 13, 2020 Category: General Medicine Authors: Katherine J. Rennie, James O ’Hara, Nikki Rousseau, Deborah Stocken, Denise Howel, Laura Ternent, Mike Drinnan, Alison Bray, Leila Rooshenas, David W. Hamilton, Alison Steel, Tony Fouweather, Ann-Marie Hynes, Eva-Maria Holstein, Yemi Oluboyede, Alaa Abo Tags: Study protocol Source Type: research

Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial
This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals ’ f... (Source: Trials)
Source: Trials - February 13, 2020 Category: General Medicine Authors: E. Q. Silva, E. Y. Suda, D. P. Santos, J. L. Ver íssimo, J. S. S. P. Ferreira, R. H. Cruvinel Júnior, R. L. Monteiro, C. D. Sartor and I. C. N. Sacco Tags: Study protocol Source Type: research

Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial
DiscussionUsing a combination of neuropsychological and neuroimaging data, the PICO Study will considerably contribute to improve the currently insufficient level of evidence on how adult patients with early-treated PKU should be managed.Trial registrationThe study is registered at clinicaltrials.gov (NCT03788343)  on the 27th of December 2018, at kofam.ch (SNCTP000003117)  on the 17th of December 2018, and on the International Clinical Trials Registry Platform of the WHO. (Source: Trials)
Source: Trials - February 13, 2020 Category: Research Source Type: clinical trials

Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial
This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals ’ foot health and quality of life. Based on the current trends of self-monitoring and self-care, providing a tool with foot-related exercises and educational care may help patients to avoid or reduce the musculoskeletal complications resulting from DPN, improving autonomous performance in daily li ving tasks. The aim of this trial is to evaluate the effects of an educational booklet for foot care and foot muscle s...
Source: Trials - February 13, 2020 Category: Research Source Type: clinical trials

Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction
DiscussionThe NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit.Trial registrationEudraCT: 2017 –000893-12, ISRCTN:16168569. Registered on 24 March 2017. (Source: Trials)
Source: Trials - February 13, 2020 Category: Research Source Type: clinical trials

Pharmacokinetics, SAfety/tolerability, and EFficacy of high-dose RIFampicin in tuberculosis-HIV co-infected patients on efavirenz- or dolutegravir-based antiretroviral therapy: study protocol for an open-label, phase II clinical trial (SAEFRIF)
This study aims to determine the safety of higher doses of rifampicin and its effect on the pharmacokinetics of efavirenz (EFV) and dolutegravir (DTG) in TB-HIV co-infected patients.MethodsThis study is a randomized, open-label, phase IIb clinical trial among TB-HIV infected adult outpatients attending an HIV clinic in Kampala, Uganda. Patients newly diagnosed with TB will be randomized to either standard-dose or high-dose rifampicin (35  mg/kg) alongside standard TB treatment. ART-naïve patients will be randomly assigned to first-line ART regimens (DTG or EFV). Those who are already on ART (DTG or EFV) at enro...
Source: Trials - February 13, 2020 Category: Research Source Type: clinical trials

Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial
This study aims to evaluate the effect of taichi in reducing blood pressure among grade 1 hypertensive patients.Methods/designIn this randomized, active-controlled, assessor-blinded, two parallel-armed trial, 80 grade 1 hypertension patients will be recruited and randomly assigned to the usual care group or to the taichi group (n = 40 in each group). Subjects who voluntarily sign a study agreement will be educated in managing their own blood pressure by restricting salt intake, losing weight, moderating alcohol consumption, performing exercise, and regulating dietary intake at their first visit. In addition t...
Source: Trials - February 13, 2020 Category: Research Source Type: clinical trials

Correction to: Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebocontrolled, randomised, double blind, multi-centre study
After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled. (Source: Trials)
Source: Trials - February 12, 2020 Category: General Medicine Authors: Frank Tegtmeier, Reinhard Schinzel, Ronny Beer, Diederik Bulters, Jean-Yves LeFrant, Joan Sahuquillo, Andreas Unterberg, Peter Andrews, Antonio Belli, Javier Ibanez, Alfonso Lagares, Michael Mokry, Harald Willschke, Charlotte Fl üh and Erich Schmutzhard Tags: Correction Source Type: research

My Bridge ( Mi Puente ), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial
We report the protocol for a randomized controlled trial that will compareMi Puente (My Bridge), a cost-efficient care transitions intervention conducted by a specially trained Behavioral Health Nurse and Volunteer Community Mentor team, to usual care or best-practice discharge approaches, in reducing hospital utilization and improving patient reported outcomes in Latino adults with multiple cardiometabolic conditions and behavioral health concerns. The study will examine the degree to whichMi Puente produces superior reductions in hospital utilization at 30 and 180  days (primary aim) and better patient-reported ou...
Source: Trials - February 12, 2020 Category: Research Source Type: clinical trials

Add-on effect of kinesiotape in patients with acute lateral ankle sprain: a randomized controlled trial
This study was a multicenter, randomized controlled clinical trial that included a per-protocol analysis of the add-on effect of KT on ALAS. The randomization was software based and only the assessors were blinded. Sixty participants (20 each from three centers) with grade I or II ALAS were randomly assigned to acupuncture (n = 30) or AcuKT (n = 30) groups. Both groups received acupuncture treatment once daily, 5 days per week for 1 week. The AcuKT group received additional KT treatment. Visual analog scale (VAS) scores for pain and the Foot and Ankle Outcome Score (FAOS) were obta...
Source: Trials - February 12, 2020 Category: Research Source Type: clinical trials

A randomized controlled trial to reduce sedentary time in rheumatoid arthritis: protocol and rationale of the Take a STAND for Health study
DiscussionFindings will be of scientific and clinical relevance with the potential to inform new prescriptions focused on reducing sedentary behavior, a modifiable risk factor that thus far has been overlooked in patients with rheumatoid arthritis.Trial registrationClinicalTrials.gov,NCT03186924. Registered on 14 June 2017. (Source: Trials)
Source: Trials - February 12, 2020 Category: Research Source Type: clinical trials

Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial
This study evaluates the efficacy of a four-session couple-based intervention delivered via telephone, called Intimacy Enhancement (IE). The IE intervention is grounded in social cognitive theory and integrates evidence-based techniques from cognitive behavioral couple therapy and sex therapy to address survivors ’ sexual concerns and enhance their and their partners’ sexual, relationship, and psychological outcomes.MethodsThis trial is designed to evaluate the efficacy of the IE intervention in improving survivors ’ sexual function, the primary study outcome. Secondary outcomes include survivors’ s...
Source: Trials - February 12, 2020 Category: Research Source Type: clinical trials

Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection
ConclusionChanges to the study protocol were introduced to improve the enrollment and follow-up of patients. Furthermore, the decrease of the sample size will facilitate completion of the trial.Trial registrationClinicalTrials.gov,NCT01792804. Registered on 13 February 2013.German Clinical trials register,DRKS00004741. Registered on 4 October 2013, EudraCT 2013-000577-77 (Source: Trials)
Source: Trials - February 12, 2020 Category: Research Source Type: clinical trials

Correction to: Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebocontrolled, randomised, double blind, multi-centre study
After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled. (Source: Trials)
Source: Trials - February 12, 2020 Category: Research Source Type: clinical trials

Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial
Impulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for... (Source: Trials)
Source: Trials - February 11, 2020 Category: General Medicine Authors: Gara Arteaga-Henr íquez, Silvia Karina Rosales-Ortiz, Alejandro Arias-Vásquez, Istvan Bitter, Ylva Ginsberg, Pol Ibañez-Jimenez, Tünde Kilencz, Catharina Lavebratt, Silke Matura, Andreas Reif, Janos Rethelyi, Vanesa Richarte, Nanda Rommelse, Anne Sieg Tags: Study protocol Source Type: research

Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol
Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patients. One of ... (Source: Trials)
Source: Trials - February 11, 2020 Category: General Medicine Authors: Mahsa Malekahmadi, Omid Moradi Moghaddam, Sheikh Mohammed Shariful Islam, Kiarash Tanha, Mohsen Nematy, Naseh Pahlavani, Safieh Firouzi, Mohammad Reza Zali and Abdolreza Norouzy Tags: Study protocol Source Type: research

Anticipatory care planning intervention for older adults at risk of functional decline: study protocol for a primary care cluster feasibility randomised trial
This study will evaluate one approach that will include primary care as the setting for ACP.Methods/designThis study will help to determine the feasibility for a definitive randomised trial to evaluate the implementation and outcomes of an ACP intervention. The intervention will be delivered by specially trained registered nurses in a primary care setting with older adults identified as at risk of functional decline. The intervention will comprise: (a) information collection via patient assessment; (b) facilitated informed dialogue between the patient, family carer, general practitioner and other healthcare practitioners; ...
Source: Trials - February 11, 2020 Category: Research Source Type: clinical trials

Improving the accuracy and efficacy of diagnosing polycystic ovary syndrome by integrating metabolomics with clinical characteristics: study protocol for a randomized controlled trial
This study aims to compare the accuracy and efficacy of diagnosing PCOS by integrating metabolomic markers with common clinical characteristics.MethodsThis is a prospective, multicenter, analyst-blinded, randomized controlled trial. Participants will be grouped into (1) people without PCOS (healthy control group), (2) patients diagnosed with PCOS based on clinical indices (experimental group 1), and (3) patients diagnosed with PCOS based on metabolomic indices (experimental group 2). A total of 276 participants, including 60 healthy people and 216 patients with PCOS, will be recruited. The 216 patients with PCOS will be ra...
Source: Trials - February 11, 2020 Category: Research Source Type: clinical trials

Protocol for a multi-centre, definitive randomised controlled trial of the effectiveness of Individual Placement and Support for employment support among people with alcohol and drug dependence
DiscussionThe IPS-AD study is the first large-scale, multi-site, definitive, superiority RCT of IPS for people with alcohol and drug dependence. Findings from the study will have substantial implications for service delivery.Trial registrationISRCTN Registry, ID:ISRCTN24159790. Registered on 1 February 2018. (Source: Trials)
Source: Trials - February 11, 2020 Category: Research Source Type: clinical trials

A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother ’s own milk for preterm infants in the NICU
AbstractBackgroundNecrotizing enterocolitis (NEC) is the leading cause of death among preterm infants born at
Source: Trials - February 11, 2020 Category: Research Source Type: clinical trials

Different electrode positioning for transcutaneous electrical nerve stimulation in the treatment of urgency in women: a study protocol for a randomized controlled clinical trial
The objective this study is to publish the study protocol that aims to investigate whether urgency decreases after treatment with both of the techniques.MethodsThis randomized controlled clinical trial will include 99 women, aged more than 18  years old, with urgency (score ≥ 8 in the Overactive Bladder-Validated 8-Question Awareness Tool [OAB-V8]). Women will be randomly allocated into three groups: TTNS, PTES, and placebo. The following questionnaires will be applied: the Anamnesis Record, the Incontinence Questionnaire Overact ive Bladder, the King’s Health Questionnaire, the 24-Hour Voidin...
Source: Trials - February 11, 2020 Category: Research Source Type: clinical trials

Instant analgesic effect of radial extracorporeal shock wave therapy on primary dysmenorrhoea according to functional magnetic resonance imaging: study protocol for a randomised placebo-controlled trial
DiscussionThis randomised controlled study is designed to explore the immediate efficacy of rESWT for PDM. After rESWT treatment, PDM symptom tests and pain tests, as well as fMRI data, will be investigated for the potential connections between immediate neuroanalgesic mechanisms, which are associated with pain and brain networks. The main results will be used to assess the efficacy of rESWT, and secondary results will focus on improving the neurobiological understanding of disease treatment.Trial registrationChina Clinical Trial Register,ChiCTR1900020678. Registered on 13 January 2019. (Source: Trials)
Source: Trials - February 11, 2020 Category: Research Source Type: clinical trials

Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol
The objective of this work is to survey the effect of pycnogenol on the clinical, nutritional, and inflammatory status of TBI patients.MethodsThis is a double-blind, randomized controlled trial. Block randomization will be used. An intervention group will receive pycnogenol supplementation of 150  mg for 10 days and a control group will receive a placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (malondialdehyde, total antioxidant capacity), at the baseline, at the 5th day, and at the end of the study (10th day) will be mea sured. Clinical a...
Source: Trials - February 11, 2020 Category: Research Source Type: clinical trials

Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial
DiscussionThis is the first randomized controlled trial to determine the effects of supplementation with synbiotics on reducing impulsive and compulsive behavior. This clinical trial can contribute to explaining the mechanisms involved in the crosstalk between the intestinal microbiome and the brain. If effects can be established by reducing impulsive and compulsive behavior, new cost-effective treatments might become available to these patients.Trial registrationClinicalTrials.gov,NCT03495375. Registered on 26 February 2018. (Source: Trials)
Source: Trials - February 11, 2020 Category: Research Source Type: clinical trials

Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial
DiscussionThis pilot randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the management of postoperative pain. It will inform the design of a further full-scale trial.Trial registrationChinese Clinical Trial Registry,ChiCTR1900024183. Registered on 29 June 2019. (Source: Trials)
Source: Trials - February 11, 2020 Category: Research Source Type: clinical trials

Comments to “PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial.”
AbstractProphylactic augmentation of the wound with mesh proposed by Kniepeiss et al is the world's first attempt to significantly reduce the risk of postoperative hernia in liver transplantation. Similar technique have been described 17 years ago in bariatric patients and confirmed by many studies in various clinical settings. The results of mesh hernia repair in patients on immunosuppressive therapy are not inferior from the data obtained from non- transplant surgery registers.To reduce the risk of using the mesh in patients scheduled for liver transplantation authors chose absorbable mesh, that maintains the mechanical ...
Source: Trials - February 11, 2020 Category: Research Source Type: clinical trials

Machine learning analysis plans for randomised controlled trials: detecting treatment effect heterogeneity with strict control of type I error
Retrospective exploratory analyses of randomised controlled trials (RCTs) seeking to identify treatment effect heterogeneity (TEH) are prone to bias and false positives. Yet the desire to learn all we can from... (Source: Trials)
Source: Trials - February 10, 2020 Category: General Medicine Authors: James A. Watson and Chris C. Holmes Tags: Methodology Source Type: research

A randomised placebo controlled trial of anakinra for treating pustular psoriasis: statistical analysis plan for stage two of the APRICOT trial
Current treatment options for Palmoplantar Pustulosis (PPP), a debilitating chronic skin disease which affects the hands and feet, are limited. The Anakinra for Pustular psoriasis: Response in a Controlled Tri... (Source: Trials)
Source: Trials - February 10, 2020 Category: General Medicine Authors: Suzie Cro, Prakash Patel, Jonathan Barker, David A. Burden, Christopher E. M. Griffiths, Helen J. Lachmann, Nick J. Reynolds, Richard B. Warren, Francesca Capon, Catherine Smith and Victoria Cornelius Tags: Update Source Type: research

Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral?
Skin-sparing mastectomy followed by immediate implant-based breast reconstruction is a commonly used treatment for breast cancer. However, when placing the implant in a subpectoral pocket, a high incidence of ... (Source: Trials)
Source: Trials - February 10, 2020 Category: General Medicine Authors: Diana L. Dyrberg, Gudjon L. Gunnarsson, Camilla Bille, Jens A. S ørensen and Jørn B. Thomsen Tags: Study protocol Source Type: research

Impact of a paediatric-adult care transition programme on the health status of patients with sickle cell disease: study protocol for a randomised controlled trial (the DREPADO trial)
Thanks to advancements in medical care, a majority of patients with sickle cell disease (SCD) worldwide live beyond 18  years of age, and therefore, patients initially followed in paediatric departments are the... (Source: Trials)
Source: Trials - February 10, 2020 Category: General Medicine Authors: Delphine Hoegy, Nathalie Bleyzac, Alexandra Gauthier-Vasserot, Giovanna Cannas, Ang élique Denis, Arnaud Hot, Yves Bertrand, Pauline Occelli, Sandrine Touzet, Claude Dussart and Audrey Janoly-Dumenil Tags: Study protocol Source Type: research

Emotion regulation training in the treatment of obesity in young adolescents: protocol for a randomized controlled trial
The prevalence rates of childhood obesity are increasing. The current multidisciplinary treatments for (childhood) obesity are effective but only moderately and in the short term. A possible explanation for th... (Source: Trials)
Source: Trials - February 10, 2020 Category: General Medicine Authors: Taaike Debeuf, Sandra Verbeken, Elisa Boelens, Brenda Volkaert, Eva Van Malderen, Nathalie Michels and Caroline Braet Tags: Study protocol Source Type: research

A randomised, double-blind, active placebo-controlled, parallel groups, dose-response study of scopolamine hydrobromide (4 –6 μg/kg) in patients with major depressive disorder
DiscussionThis trial contributes to the literature surrounding the efficacy of scopolamine as an antidepressant. Determining the dose –response profile and washout period of scopolamine’s antidepressant effect will also provide important information for designing and conducting crossover trials. The use of an active placebo is important to reduce potentially confounding expectancy effects.Trial registrationThe trial was registered in the Australian New Zealand Clinical Trials Registry (registration numberACTRN12619000569101). Registered on 11 April 2019. (Source: Trials)
Source: Trials - February 10, 2020 Category: Research Source Type: clinical trials

Emotion regulation training in the treatment of obesity in young adolescents: protocol for a randomized controlled trial
This study will add to both the scientific and clinical literature on the role of emotion regulation in the development and maintenance of different psychopathologies, as emotion regulation is a transdiagnostic factor.Trial registrationThe RCT study protocol is registered at ISRCTN Registry, with study ID “ISRCTN 83822934. ” Registered on 13 December 2017. (Source: Trials)
Source: Trials - February 10, 2020 Category: Research Source Type: clinical trials

Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial
DiscussionThe results of this trial will have a real impact on public health if it is shown that a Kenacort retard ® (i.e. triamcinolone) injection costing just €2.84 and performed in the physician’s office (with no additional overhead costs) is at least as effective as the dexamethasone 700 μg implant (Ozurdex®; costing approximately €960 with the injection performed in a dedicated room), with no inc reased side effects.Trial registrationClinicalTrials.gov,NCT02556424. Registered on 22 September 2015. (Source: Trials)
Source: Trials - February 10, 2020 Category: Research Source Type: clinical trials

Sinako, a study on HIV competent households in South Africa: a cluster-randomised controlled trial protocol
DiscussionStimulating HIV competence in households could be a feasible and sustainable strategy to optimise the outcomes of CHW interventions and thus be important for HIV treatment interventions in resource-limited settings.Trial registrationPan African Clinical Trial Registry,PACTR201906476052236. Registered on 24 June 2019. (Source: Trials)
Source: Trials - February 10, 2020 Category: Research Source Type: clinical trials