Quantifying the advantages of conducting a prospective meta-analysis (PMA): a case study of early childhood obesity prevention
ConclusionProspective planning led to greater outcome harmonisation and greater power to detect intervention effects, while maintaining acceptable variation in trial designs and populations, which improved external validity. Recommendations for future PMA include more detailed harmonisation of outcome measures and careful pre-specification of analyses to avoid research waste by unnecessary over-collection of data. (Source: Trials)
Source: Trials - January 22, 2021 Category: Research Source Type: clinical trials

The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial
This study is retrospectively registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn) on 19 April 2018. ID: ChiCTR1800015768. (Source: Trials)
Source: Trials - January 22, 2021 Category: Research Source Type: clinical trials

Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial
Thin endometrium negatively impacts the reproductive function. Current treatments for thin endometrium do not always improve endometrial receptivity. Preliminary evidence suggests that electroacupuncture could... (Source: Trials)
Source: Trials - January 21, 2021 Category: General Medicine Authors: Fangyuan Li, Hua Lu, Xinxin Wang, Qi Zhang, Qianchen Liu and Tong Wang Tags: Study protocol Source Type: research

Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial
The incidence rate of Hashimoto thyroiditis (HT) has gradually increased in recent years. There has been no specific etiological treatment for HT. Even though with normal level of thyroid hormone, the patients... (Source: Trials)
Source: Trials - January 21, 2021 Category: General Medicine Authors: Shanze Wang, Jiping Zhao, Weimei Zeng, Wanqing Du, Tenghui Zhong, Hui Gao, Yi Xiao and Chao Yang Tags: Study protocol Source Type: research

Efficacy of silver needle therapy for the treatment of chronic nonspecific low back pain: a prospective, single-center, randomized, parallel-controlled clinical trial
Chronic nonspecific low back pain (CNSLBP) troubles approximately 30% of people worldwide. Silver needle therapy (SNT) is a treatment method to relieve soft tissue pain through heating. Therefore, this study a... (Source: Trials)
Source: Trials - January 21, 2021 Category: General Medicine Authors: Xuesong Hu, Shaoxing Dong, Bing Zhang, Xuan Wang, Yanwei Yin, Chuansheng Liu, Junmin Yu, Xing Wu, Fenghu Xu and Chao Meng Tags: Research Source Type: research

Commentary on ‘Exclusion rates in randomized trials of treatments for physical conditions: a systematic review’
(Source: Trials)
Source: Trials - January 21, 2021 Category: General Medicine Authors: Anna Ugalde, Nicole Kiss, Patricia M. Livingston and Nicole Rankin Tags: Commentary Source Type: research

The coArtHA trial —identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial
Arterial hypertension is the most prevalent risk factor for cardiovascular disease in sub-Saharan Africa. Only a few and mostly small randomized trials have studied antihypertensive treatments in people of Afr... (Source: Trials)
Source: Trials - January 21, 2021 Category: General Medicine Authors: Herry Mapesi, Ravi Gupta, Herieth Ismael Wilson, Blaise Lukau, Alain Amstutz, Aza Lyimo, Josephine Muhairwe, Elizabeth Senkoro, Theonestina Byakuzana, Madavida Mphunyane, Moniek Bresser, Tracy Ren ée Glass, Mark Lambiris, Günther Fink, Winfrid Gingo, Ma Tags: Study protocol Source Type: research

Intersectoral care management for older people with cognitive impairment during and after hospital stays [intersec-CM]: study protocol for a process evaluation within a randomised controlled trial
ConclusionsThe results of our process evaluation may serve as an implementation guideline for intersectoral care management in the German healthcare system. Furthermore, the approach to evaluate the process of a complex intervention in health care for older PCI may serve as a stimulus to broaden the evidence base also of other complex intervention studies to improve health care for this vulnerable group.The study was ethically approved by the Ethics Committee of the Ernst-Moritz-Arndt University of Greifswald. The study has been registered at the U.S. National Library of Medicine.Trial registrationClinicalTrials.govNCT0335...
Source: Trials - January 21, 2021 Category: Research Source Type: clinical trials

The coArtHA trial —identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial
AbstractBackgroundArterial hypertension is the most prevalent risk factor for cardiovascular disease in sub-Saharan Africa. Only a few and mostly small randomized trials have studied antihypertensive treatments in people of African descent living in sub-Saharan Africa.MethodsIn this open-label, three-arm, parallel randomized controlled trial conducted at two rural hospitals in Lesotho and Tanzania, we compare the efficacy and cost-effectiveness of three antihypertensive treatment strategies among participants aged ≥ 18 years. The study includes patients with untreated uncomplicated arterial hypertension di...
Source: Trials - January 21, 2021 Category: Research Source Type: clinical trials

Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial
This study aims to assess the feasibility, efficacy, and safety of acupuncture for HT.MethodsThis is a randomized, black-controlled assessor-blinded pilot trial. A total of 60 patients will be recruited and divided into the experimental group (n = 30) or the control group (n = 30). The experimental group will undergo acupuncture therapy (penetration needling of Hand-Yangming meridian, PNHM) for 16 weeks, followed by a 16-week follow-up period, and the control group will first go through an observation period for 16 weeks, followed by a 16-week compensation PNHM therapy. The primary...
Source: Trials - January 21, 2021 Category: Research Source Type: clinical trials

Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial
This study is a randomized, single-blinded, controlled, clinical trial. A total of 142 eligible patients will be recruited and randomly assigned to the electroacupuncture (EA) group or the sham electroacupuncture (SEA) group in a 1:1 ratio. Participants will receive 36 sessions over three menstrual cycles (12  weeks in total), with the same acupoint prescription. The primary outcome of this trial is endometrial thickness in the midluteal phase. The secondary outcomes include endometrial pattern, resistance index (RI) and pulsatility index (PI) of bilateral uterine artery and endometrium blood flow, ser um estradiol ...
Source: Trials - January 21, 2021 Category: Research Source Type: clinical trials

Efficacy of silver needle therapy for the treatment of chronic nonspecific low back pain: a prospective, single-center, randomized, parallel-controlled clinical trial
In this study, 100 patients were randomly divided into 2 groups: silver needle (SN) group and control group (n = 50). In the SN group, patients received SNT and physiotherapy, while patients received physiotherapy alone in the control group. At the 6-month follow-up, the numerical rating scale (NRS), Oswestry Disability Index (ODI), Short-Form 12 of quality of life (SF-12), the natural logarithms of low -frequency measurement (InLF), and the natural logarithms of high-frequency measurement (InHF) of heart rate variability (HRV) were recorded.ResultsIn both groups, NRS, ODI, SF-12 scores, and HRV at 2  ...
Source: Trials - January 21, 2021 Category: Research Source Type: clinical trials

Commentary on ‘Exclusion rates in randomized trials of treatments for physical conditions: a systematic review’
(Source: Trials)
Source: Trials - January 21, 2021 Category: Research Source Type: clinical trials

Evaluation of the efficacy and safety of icatibant and C1 esterase/kallikrein inhibitor in severe COVID-19: study protocol for a three-armed randomized controlled trial
DiscussionAccumulation of bradykinin in the lungs is a common side effect of ACE inhibitors leading to cough. In animal models, the inactivation of ACE2 leads to severe acute pneumonitis in response to lipopolysaccharide (LPS), and the inhibition of bradykinin almost completely restores the lung structure. We believe that inhibition of bradykinin in severe COVID-19 patients could reduce the lung inflammatory response, impacting positively on the severity of disease and mortality rates.Trial registrationBrazilian Clinical Trials Registry Universal Trial Number (UTN)U1111-1250-1843. Registered on May/5/2020. (Source: Trials)
Source: Trials - January 20, 2021 Category: Research Source Type: clinical trials

Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial
DiscussionThis clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease.Trial registrationClinicalTrials.govNCT04345523. Registered on 30 March, 2020. First posted date: April 14, 2020. (Source: Trials)
Source: Trials - January 20, 2021 Category: Research Source Type: clinical trials

In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable
Imaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availabilit... (Source: Trials)
Source: Trials - January 19, 2021 Category: General Medicine Authors: Aldo Badano Tags: Commentary Source Type: research

Mentoring upcoming researchers for non-communicable diseases ’ research and practice in Malawi
The Malawi College of Medicine and its partners are building non-communicable diseases ’ (NCDs’) research capacity through a grant from the National Heart, Lung and Blood Institute (NHLBI) of the National Insti... (Source: Trials)
Source: Trials - January 19, 2021 Category: General Medicine Authors: Adamson S. Muula, Mina C. Hosseinipour, Martha Makwero, Johnstone Kumwenda, Prosper Lutala, Mary Mbeba, Sarah Rylance, Collins Mitambo and Moffat Nyirenda Tags: Commentary Source Type: research

The Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern (CHARM): a study protocol for a double-blinded randomized controlled trial
Atopic dermatitis (AD) is a complex, common inflammatory skin disease. The Chinese herbal formula Huoxiang Zhengqi (HXZQ) has been a common dermatosis treatment in China for many years, but there is no high-le... (Source: Trials)
Source: Trials - January 19, 2021 Category: General Medicine Authors: Meiling Xuan, Xiaohui Guo, Hongyi Li, Ting Xie, Xiumei Mo and Zehuai Wen Tags: Study protocol Source Type: research

Utilising benefit-risk assessments within clinical trials —a protocol for the BRAINS project
Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of superiority, equivalence or non-inferiority. The design of the study is affected by many different elem... (Source: Trials)
Source: Trials - January 19, 2021 Category: General Medicine Authors: Nikki Totton, Steven Julious, Dyfrig Hughes, Jonathan Cook, Katie Biggs, Lizzie Coates, Andrew Cook, Catherine Hewitt and Simon Day Tags: Study protocol Source Type: research

Mingjing granule, a traditional Chinese medicine in the treatment of neovascular age-related macular degeneration: study protocol for a randomized controlled trial
Neovascular age-related macular degeneration (nAMD) is the most common cause of irreversible vision loss and blindness among the older people aged 50 and over. Although anti-vascular endothelial growth factor ... (Source: Trials)
Source: Trials - January 19, 2021 Category: General Medicine Authors: Yamin Li, Lina Liang, Torkel Snellingen, Kai Xu, Yun Gao, Fengmei Zhang, Chengwei Guo, Tao Zuo, Fengming Liang, Xiaoping Yao and Xueyan Yang Tags: Study protocol Source Type: research

Mingjing granule, a traditional Chinese medicine in the treatment of neovascular age-related macular degeneration: study protocol for a randomized controlled trial
DiscussionBased on previous empirical and animal laboratory studies, this study will address the question of whether Mingjing granule could contribute to improving efficacy, safety, and efficiency with need for fewer intravitreal injections of anti-VEGF, improving compliance and visual outcomes in the management of persons with nAMD.Trial registrationChinese Clinical Trial Registry (http://www.chictr.org.cn),ChiCTR2000035990. Registered on 21 August 2020. (Source: Trials)
Source: Trials - January 19, 2021 Category: Research Source Type: clinical trials

Utilising benefit-risk assessments within clinical trials —a protocol for the BRAINS project
DiscussionThe aim of the project is to provide a guideline for clinical researchers, grant funding bodies and reviewers for grant bodies for how to select the most appropriate trial design and when it is appropriate to consider using benefit-risk methods. The focus of the guideline will be on publicly funded trials however, the vision is that the work will be applicable across research settings and we will connect with other organisations and committees as appropriate. (Source: Trials)
Source: Trials - January 19, 2021 Category: Research Source Type: clinical trials

Statistical analysis plan for management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: the SingHypertension pragmatic cluster randomized controlled trial
This article describes the statistical analysis plan for the primary and secondary objectives related to intervention effectiveness.MethodsThe study is a cluster randomized trial enrolling 1000 participants with uncontrolled hypertension aged ≥ 40 years from eight primary care clinics in Singapore. The unit of randomization is the clinic, with eight clusters (clinics) randomized in a 1:1 ratio to either MCI or usual care. All participants will be assessed at baseline, 12 months, and 24 months with measurements of systolic and d iastolic BP, antihypertensive and statin medication use, medicati...
Source: Trials - January 19, 2021 Category: Research Source Type: clinical trials

Mentoring upcoming researchers for non-communicable diseases ’ research and practice in Malawi
AbstractThe Malawi College of Medicine and its partners are building non-communicable diseases ’ (NCDs’) research capacity through a grant from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health. Several strategies are being implemented including research mentorship for junior researchers interested to build careers in NCDs’ research. In this artic le, we present the rationale for and our experiences with this mentorship program over its 2 years of implementation. Lessons learned and the challenges are also shared. (Source: Trials)
Source: Trials - January 19, 2021 Category: Research Source Type: clinical trials

The Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern (CHARM): a study protocol for a double-blinded randomized controlled trial
DiscussionThe goal of this trial is to evaluate the efficacy and availability of HXZQ oral liquid in treating AD/eczema in terms of symptoms and eczematous lesions. It will also address whether it has positive effect on QoL.Trial registrationChinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx): Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern (CHARM): a double-blinded randomized controlled trial,ChiCTR1900026700. Registered on 19 October 2019. (Source: Trials)
Source: Trials - January 19, 2021 Category: Research Source Type: clinical trials

In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable
AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study). (Source: Trials)
Source: Trials - January 19, 2021 Category: Research Source Type: clinical trials

Evaluation of the efficacy and safety of inhaled magnesium sulphate in combination with standard treatment in patients with moderate or severe COVID-19: A structured summary of a study protocol for a randomised controlled trial
Basic and clinical studies have shown that magnesium sulphate ameliorates lung injury and controls asthma attacks by anti-inflammatory and bronchodilatory effects. Both intravenous and inhaled magnesium sulpha... (Source: Trials)
Source: Trials - January 18, 2021 Category: General Medicine Authors: Guitti Pourdowlat, Seyed Ruhollah Mousavinasab, Behrooz Farzanegan, Alireza Kashefizadeh, Zohreh Akhoundi Meybodi, Maedeh Jafarzadeh and Shadi Baniasadi Tags: Letter Source Type: research

Diabetes management intervention studies: lessons learned from two studies
Several clinical studies investigated improvements of patient outcomes due to diabetes management interventions. However, chronic disease management is intricate with complex multifactorial behavior patterns. ... (Source: Trials)
Source: Trials - January 18, 2021 Category: General Medicine Authors: Bettina Petersen, Iris Vesper, Bernhild Pachwald, Nicole Dagenbach, Sina Buck, Delia Waldenmaier and Lutz Heinemann Tags: Methodology Source Type: research

Managing clinical trials during COVID-19: experience from a clinical research facility
There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the co... (Source: Trials)
Source: Trials - January 18, 2021 Category: General Medicine Authors: Frances Shiely, Jean Foley, Amy Stone, Emma Cobbe, Shaunagh Browne, Ellen Murphy, Maeve Kelsey, Joanne Walsh-Crowley and Joseph A. Eustace Tags: Commentary Source Type: research

Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial
Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleedin... (Source: Trials)
Source: Trials - January 18, 2021 Category: General Medicine Authors: Ayla S. Turan, Leon M. G. Moons, Ramon-Michel Schreuder, Erik J. Schoon, Jochim S. Terhaar sive Droste, Ruud W. M. Schrauwen, Jan Willem Straathof, Barbara A. J. Bastiaansen, Matthijs P. Schwartz, Wouter L. Hazen, Alaa Alkhalaf, Daud Allajar, Muhammed Had Tags: Study protocol Source Type: research

Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial
AbstractBackgroundEndoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleeding, occurring in 7% overall and in approximately 10% of polyps ≥ 2 cm in the proximal colon. Previous research has suggested that prophylactic clipping of the mucosal defect after EMR may reduce the incidence of delayed bleeding in polyps with a high bleeding risk.MethodsThe CLIPPER trial is a multicenter, parallel-group, single blinded, randomized controlled superiority study. A tota...
Source: Trials - January 18, 2021 Category: Research Source Type: clinical trials

Evaluation of the efficacy and safety of inhaled magnesium sulphate in combination with standard treatment in patients with moderate or severe COVID-19: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesBasic and clinical studies have shown that magnesium sulphate ameliorates lung injury and controls asthma attacks by anti-inflammatory and bronchodilatory effects. Both intravenous and inhaled magnesium sulphate have a clinical impact on acute severe asthma by inhibition of airway smooth muscle contraction. Besides, magnesium sulphate can dilate constricted pulmonary arteries and reduce pulmonary artery resistance. However, it may affect systemic arteries when administered intravenously. A large number of patients with covid-19 admitted to the hospital suffer from pulmonary involvement. COVID-19 can cause...
Source: Trials - January 18, 2021 Category: Research Source Type: clinical trials

Diabetes management intervention studies: lessons learned from two studies
ConclusionThere are several aspects to consider in medical device studies when using interventions that rely on changes in behavior to achieve an effective implementation and significant study results. Improvements in the control group may reduce effect sizes and limit statistical significance; therefore, alternatives to the traditional randomized controlled trials may be considered. (Source: Trials)
Source: Trials - January 18, 2021 Category: Research Source Type: clinical trials

Managing clinical trials during COVID-19: experience from a clinical research facility
AbstractThere is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solvin...
Source: Trials - January 18, 2021 Category: Research Source Type: clinical trials

Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs
Several drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosag... (Source: Trials)
Source: Trials - January 15, 2021 Category: General Medicine Authors: Florence Rodgers, Toby Pepperrell, Sarai Keestra and Victoria Pilkington Tags: Research Source Type: research

Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs
ConclusionsThere is an important evidence gap for the safety of drugs being repurposed for COVID-19. This uncertainty could cause unnecessary additional morbidity and mortality during the pandemic. We recommend caution in experimental drug use for non-severe disease and urge clinical trial sponsors to report missing results retrospectively. (Source: Trials)
Source: Trials - January 15, 2021 Category: Research Source Type: clinical trials

The NYCKidSeq project: study protocol for a randomized controlled trial incorporating genomics into the clinical care of diverse New York City children
Increasingly, genomics is informing clinical practice, but challenges remain for medical professionals lacking genetics expertise, and in access to and clinical utility of genomic testing for minority and unde... (Source: Trials)
Source: Trials - January 14, 2021 Category: General Medicine Authors: Jacqueline A. Odgis, Katie M. Gallagher, Sabrina A. Suckiel, Katherine E. Donohue, Michelle A. Ramos, Nicole R. Kelly, Gabrielle Bertier, Christina Blackburn, Kaitlyn Brown, Lena Fielding, Jessenia Lopez, Karla Lopez Aguiniga, Estefany Maria, Jessica E. R Tags: Study protocol Source Type: research

The reality of informed consent: empirical studies on patient comprehension —systematic review
Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which pati... (Source: Trials)
Source: Trials - January 14, 2021 Category: General Medicine Authors: Tomasz Pietrzykowski and Katarzyna Smilowska Tags: Review Source Type: research

Physiotherapeutic scoliosis-specific exercises performed immediately after spinal manipulative therapy for the treatment of mild adolescent idiopathic scoliosis: study protocol for a randomized controlled pilot trial
Spinal manipulative therapy is commonly used in the treatment of adolescent idiopathic scoliosis. Some therapists also rely on physiotherapeutic scoliosis-specific exercise (PSSE). Combining these two modaliti... (Source: Trials)
Source: Trials - January 14, 2021 Category: General Medicine Authors: Li Wang, Chun Wang, Ahmed S. A. Youssef, Jiang Xu, Xiaolin Huang and Nan Xia Tags: Study protocol Source Type: research

The NYCKidSeq project: study protocol for a randomized controlled trial incorporating genomics into the clinical care of diverse New York City children
This study will evaluate the use of a novel, digital platform (GU ÍA) to digitize the return of genomic results experience and improve participant understanding for English- and Spanish-speaking families. Surveys will collect data at three study visits: baseline (0 months), result disclosure visit (ROR1, + 3 months), and follow-up visit (ROR2, + 9 month s). Outcomes will assess parental understanding of and attitudes toward receiving genomic results for their child and behavioral, psychological, and social impact of results. We will also conduct a pilot study to assess a digital to...
Source: Trials - January 14, 2021 Category: Research Source Type: clinical trials

Physiotherapeutic scoliosis-specific exercises performed immediately after spinal manipulative therapy for the treatment of mild adolescent idiopathic scoliosis: study protocol for a randomized controlled pilot trial
This study will inform the design of a future full-scale trial. The outcomes will provide preliminary data about the efficacy of the combination of spinal manipulative therapy and exercise in treating scoliosis.Trial registrationProspectively registered at Chinese clinical trial registry,ChiCTR1900027037. Registered on 29 October 2019.http://www.chictr.org.cn/edit.aspx?pid=44954&htm=4 (Source: Trials)
Source: Trials - January 14, 2021 Category: Research Source Type: clinical trials

The reality of informed consent: empirical studies on patient comprehension —systematic review
ConclusionsWe found that participants ’ comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients’ full and genuine involvement in a shared medical decision-making process. (Source: Trials)
Source: Trials - January 14, 2021 Category: Research Source Type: clinical trials

Chinese herbal extract granules combined with 5-aminosalicylic acid for patients with moderately active ulcerative colitis: study protocol for a multicenter randomized double-blind placebo-controlled trial
Ulcerative colitis (UC) is an intestinal inflammatory disease characterized by inflammation of the colonic mucosa. With unknown pathogenesis, it has become a chronic lifetime disorder worldwide. In patients wi... (Source: Trials)
Source: Trials - January 13, 2021 Category: General Medicine Authors: Zhaofeng Shen, Kai Zheng, Jiandong Zou, Peiqing Gu, Jing Xing, Lu Zhang, Lei Zhu and Hong Shen Tags: Study protocol Source Type: research

Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study
Randomised controlled trials (RCTs) are considered the ‘gold standard’ of medical evidence; however, recruitment can be challenging. The MACRO trial is a NIHR-funded RCT for chronic rhinosinusitis (CRS) addres... (Source: Trials)
Source: Trials - January 13, 2021 Category: General Medicine Authors: Clare McDermott, Jane Vennik, Carl Philpott, Steffi le Conte, Mike Thomas, Caroline Eyles, Paul Little, Helen Blackshaw, Anne Schilder and Claire Hopkins Tags: Research Source Type: research

Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study
ConclusionThe MACRO conversation study contributed to the learning process of optimising recruitment by helping to identify and address recruitment issues. Although some issues were trial-specific, others have applicability to many clinical trial situations. Using qualitative research techniques to identify/explore barriers and facilitators to recruitment may be valuable during the pilot phase of many RCTs including those with complex designs. (Source: Trials)
Source: Trials - January 13, 2021 Category: Research Source Type: clinical trials

Chinese herbal extract granules combined with 5-aminosalicylic acid for patients with moderately active ulcerative colitis: study protocol for a multicenter randomized double-blind placebo-controlled trial
DiscussionThis is the first randomized controlled clinical study protocol regarding Chinese herbal extract granules in the management of moderately active UC. We aim to investigate the superiority of QCHS granules over placebo in terms of induction of remission. If the trial shows significant benefits of QCHS granules, it will help clinical practitioners, UC patients, and policymakers make more informed choices in the decision-making.Trial registrationChinese Clinical Trial RegistryChiCTR-IOR-14005554. Registered on 27 November 2014. (Source: Trials)
Source: Trials - January 13, 2021 Category: Research Source Type: clinical trials

A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study
Following the World Health Organization ’s (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-S... (Source: Trials)
Source: Trials - January 12, 2021 Category: General Medicine Authors: Mohammed Limbada, Chiti Bwalya, David Macleod, Sian Floyd, Ab Schaap, Vasty Situmbeko, Richard Hayes, Sarah Fidler and Helen Ayles Tags: Methodology Source Type: research

Using brain functional magnetic resonance imaging to evaluate the effectiveness of acupuncture combined with mirror therapy on upper limb function in patients with cerebral ischemic stroke: a study protocol for a randomized, controlled trial
This study aims to combi... (Source: Trials)
Source: Trials - January 12, 2021 Category: General Medicine Authors: Mingzhu Xu, Run Lin, Jing Luo, Chunzhi Tang, Shuhui Wang, John Wong, Meng Wu, Jianting Huang, Peng Shi, Ang Gao, Yuqian Bai, Ying Xie, Jun Luo, Yunqiu Yang and Shaoyang Cui Tags: Study protocol Source Type: research

Using brain functional magnetic resonance imaging to evaluate the effectiveness of acupuncture combined with mirror therapy on upper limb function in patients with cerebral ischemic stroke: a study protocol for a randomized, controlled trial
This study aims to combine Jin ’s three-needle acupuncture (JTN) therapy with mirror therapy (MT) for hemiplegia after CIS, objectively evaluate the clinical effects and safety of JTN to treat upper limb dysfunction, and use functional magnetic resonance imaging (fMRI) of the brain to investigate the central mechanisms of the e ffects, which would provide a powerful evidence-based medical basis for further supporting the application of JTN combined with MT.Methods/designThis trial will be a single-blind, randomized controlled study. Patients who meet the study criteria will be recruited and randomly assigned to eithe...
Source: Trials - January 12, 2021 Category: Research Source Type: clinical trials

A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study
DiscussionThis trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings.Trial registrationClinicalTrials.govNCT03025165. Registered on 19 January 2017 (Source: Trials)
Source: Trials - January 12, 2021 Category: Research Source Type: clinical trials