Trametinib and Everolimus for the Treatment of Pediatric and Young Adult Patients With Recurrent Low Grade Gliomas (PNOC021)
Condition:   Recurrent World Health Organization (WHO) Grade II Glioma Interventions:   Drug: Everolimus;   Drug: Trametinib Sponsors:   University of California, San Francisco;   Novartis Pharmaceuticals;   Pediatric Brain Tumor Foundation;   The Lilabean Foundation for Pediatric Brain Cancer Research Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 24, 2020 Category: Research Source Type: clinical trials

Evaluating interventions to improve test, treat, and track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS) in some rural communities of Fanteakwa North district, Ghana: study protocol for a cluster randomized controlled trial
DiscussionThe trial will provide evidence on the combined effectiveness of provider and community interventions in improving adherence to the T3 initiative among OTCMS in rural Ghana.Ethical clearanceNMIMR-IRB CPN 086/18-19Trial registrationISRCTN registryISRCTN77836926. Registered on 4 November 2019. (Source: Trials)
Source: Trials - July 8, 2020 Category: Research Source Type: clinical trials

FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial
DiscussionThe treatment frequently used in female acne is systemic antibiotics with many courses, as it is a chronic inflammatory disease. In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage.Trial registrationClinicalTrials.gov:NCT03334682. Registered on 7 November 2017. (Source: Trials)
Source: Trials - June 25, 2020 Category: Research Source Type: clinical trials

Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs
DiscussionRepresenting a novel model of care suited to reach and engage marginalized PWID in HCV care, this study will inform HCV elimination efforts locally and internationally. If the model proves efficacious and feasible, it should be considered for broader implementation, replacing the current standard of care.Trial registrationClinicalTrials.gov,NCT04220645. Registered on 7 January 2020. (Source: Trials)
Source: Trials - June 15, 2020 Category: Research Source Type: clinical trials

Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II)
AbstractObjectivesTo assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19.Trial designThis is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial.ParticipantsTwenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020. Inclusion Criteria: hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below:Adults aged 18-65 years;Voluntarily participate in this clinical trial and sign the “informed consent form...
Source: Trials - June 12, 2020 Category: Research Source Type: clinical trials

Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial
AbstractObjectivesThe aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection.Trial DesignThis is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor.ParticipantsEligible participants include adults ( ≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room ai...
Source: Trials - June 8, 2020 Category: Research Source Type: clinical trials

A group- and smartphone-based psychological intervention to increase and maintain physical activity in patients with musculoskeletal conditions: study protocol for a randomized controlled trial ( “MoVo-App”)
DiscussionThis is the first evaluation of the effectiveness of an app in combination with a face-to-face group intervention to promote physical activity. The approach of using an app in addition to an effective face-to-face intervention program, both based on the MoVo model, might sustain positive intervention effects introduced in routine health care.Trial registrationThe trial “A group- and smartphone-based psychological intervention to increase physical activity in patients with musculoskeletal conditions: A randomized controlled trial” is registered at the World Health Organization International Clinical Tr...
Source: Trials - June 8, 2020 Category: Research Source Type: clinical trials

Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial
DiscussionOn April 30, 2014, the World Health Organization published an alarming report on antibiotic resistance. Finding an alternative medical treatment to antibiotics in order to prevent relapses of pouchitis is therefore becoming increasingly important given the risk posed by multiresistant bacteria. Moreover, if the results of this study are conclusive, FMT, which is less expensive than biologics, could become a routine treatment in the future.Trial registrationClinicalTrials.gov,NCT03524352. Registered on 14 May 2018. (Source: Trials)
Source: Trials - June 3, 2020 Category: Research Source Type: clinical trials

Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial
This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services.Intervention and comparatorCOVID-19 confirmed patients will be randomly assigned to one of three groups, with 20 patients in each. The first group (Arm 1) will receive Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon- β 1a (Recigen), the second group (Arm 2) will be administered Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1b (Ziferon), and the control group (Arm 3) will be treated by Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra).Main outcom...
Source: Trials - June 3, 2020 Category: Research Source Type: clinical trials

A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol
AbstractBackgroundAcute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops, or ‘delayed’ orally administered antibiotics, could be at least as effective and safe as immediate oral...
Source: Trials - June 3, 2020 Category: Research Source Type: clinical trials

Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial
DiscussionThis is the first randomized, placebo-controlled trial in COVID-19. Enrolment began in sites in Wuhan, Hubei Province, China on 6th February 2020.Trial registrationClinicalTrials.gov: NCT04257656. Registered on 6 February 2020. (Source: Trials)
Source: Trials - May 24, 2020 Category: Research Source Type: clinical trials

Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study
DiscussionThis trial will be the first clinical trial to assess the efficacy and safety of OKT in the treatment of CHF. We anticipate that the findings of the study will provide evidence for the basis of using OKT in treating CHF symptoms and generate basic data for designing a further large-scale randomized clinical trial.Trial registrationClinical Research Information Service (CRIS):KCT0003723. Retrospectively registered on 8 April 2019. (Source: Trials)
Source: Trials - May 18, 2020 Category: Research Source Type: clinical trials

Survive and Thrive in Brazil: The Boa Vista Early Childhood Program: study protocol of a stepped-wedge, randomized controlled trial
The objective of this project was to test the feasibility, impact, and relative cost-effectiveness of an adapted “Reach Up and Learn” program delivered through home-visiting programs as well as through center-based parenting groups on child health and development in the municipality of Boa Vista, Brazil.MethodsA randomized, stepped-wedge design was used to roll out and evaluate the two parenting platforms in Boa Vista municipality. A total of 39 neighborhoods with a high Neighborhood Vulnerability Index were selected for the study. For the first phase of the program, nine neighborhoods were randomly selected fo...
Source: Trials - May 7, 2020 Category: Research Source Type: clinical trials

Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial
This study aims to evaluate the effectiveness of pillbox-enabled self-administered therapy (SAT) compared to standard DOT on adherence to TB medication and treatment outcomes in Ethiopia. It also aims to assess the usability, acceptability, and cost-effectiveness of the intervention from the patient and provider perspectives.MethodsThis is a multicenter, randomized, controlled, open-label, superiority, effectiveness-implementation hybrid, mixed-methods, two-arm trial. The study is designed to enroll 144 outpatients with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary TB who are eligible to ...
Source: Trials - May 5, 2020 Category: Research Source Type: clinical trials

Lay-therapist-delivered, low-intensity, psychosocial intervention for refugees and asylum seekers (PROSPER): protocol for a pilot randomised controlled trial
DiscussionWe will use these findings to specify the parameters for a full RCT to test the effectiveness and cost-effectiveness of PM+ in reducing emotional distress and health inequalities, and improving functional ability and wellbeing, amongst asylum seekers and refugees.Trial registrationISRCTN, ID:ISRCTN15214107. Registered on 10 September 2019. (Source: Trials)
Source: Trials - April 28, 2020 Category: Research Source Type: clinical trials

Design and implementation of an intelligent monitoring system for household added salt consumption in China based on a real-world study: a randomized controlled trial
This study will be the first to explore the effect of the household added salt monitoring system on the reduction in salt intake in households. If the intelligent monitoring system is found to be effective in limiting household added salt consumption, it could provide scientific evidence on reducing salt consumption and preventing salt-related chronic diseases.Trial registrationChinese clinical trial registry (Primary registry in the World Health Organization registry network):ChiCTR1800018586. Date of registration: September 25, 2018. (Source: Trials)
Source: Trials - April 21, 2020 Category: Research Source Type: clinical trials

Effectiveness of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease-modifying antirheumatic drugs (TOPIRA): study protocol for a pragmatic trial
DiscussionThis will be the first randomized clinical trial comparing addition of oral prednisone or of tocilizumab head to head in RA patients with insufficient response to csDMARD therapy. It will yield important information for clinical rheumatology practice.Trial registrationThis trial was prospectively registered in the Netherlands Trial Register on October 7, 2019 (NL8070). The Netherlands Trial Register contains all items from the World Health Organization Trial Registration Data Set. (Source: Trials)
Source: Trials - April 5, 2020 Category: Research Source Type: clinical trials

Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey
DiscussionThe treatment manual of the Syrian-Arabic Group PM+ and training materials will be made available through the WHO once the effectiveness and cost-effectiveness of Group PM+ have been established.Trial registrationClinical Trial Registration: ClinicalTrials.gov IdentifierNCT03960892. Unique protocol ID: 10/2017. Prospectively registered on 21 May 2019. (Source: Trials)
Source: Trials - March 20, 2020 Category: Research Source Type: clinical trials

Atmiyata, a community-led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India
DiscussionStepped wedge designs are increasingly used a design to evaluate the real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a low- and middle-income country evaluating the impact of the implementation of a community mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in low- and middle-income countries.Trial registrationThe trial is registered prospectively with the Clinical Trial Registry in India and the Clinical Trial Reg...
Source: Trials - February 21, 2020 Category: Research Source Type: clinical trials

Effect of transcranial direct current stimulation and multicomponent training on functional capacity in older adults: protocol for a randomized, controlled, double-blind clinical trial
The objective of this study is to evaluate the effect of multicomponent training associated with active or sham tDCS on the performance of functional capacity in the elderly before treatment, after treatment and 30 days after the end of treatment. The secondary objective will be to correlate the performance of the primary outcome (functional capacity assessed by the Glittre Daily Life Activity Test) with walking capacity (by 6-min walk test), balance (with the mini-Balance Evaluation Systems Test), functional independence (by the Functional Independence Measure) and quality of life (with the World Health Organization Quali...
Source: Trials - February 19, 2020 Category: Research Source Type: clinical trials

Rugby Fans in Training New Zealand (RUFIT-NZ): protocol for a randomized controlled trial to assess the effectiveness and cost-effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand
The objective of this trial is to determine the effectiveness and cost-effectiveness of the Rugby Fans in Training New Zealand (RUFIT-NZ) pro gram.MethodsA pragmatic, two-arm, multi-center, randomized controlled trial involving 308 overweight and obese men aged 30 –65 years, randomized to either an intervention group (n = 154) or a wait-list control group (n = 154). The intervention-group participated in the 12-week RUFIT-NZ program, a gender-sensitized, healthy lifestyle intervention adapted to the environment and cultural diversity of NZ and delivered through professional rugby clubs....
Source: Trials - February 4, 2020 Category: Research Source Type: clinical trials

Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors
DiscussionResults of this RCT are expected to extend the body of knowledge with regard to the effectiveness of CBT-based Internet interventions for female breast cancer survivors.Trial registrationClinicalTrials.gov,NCT03643640. Registered on 23 August 2018. (Source: Trials)
Source: Trials - January 29, 2020 Category: Research Source Type: clinical trials

A double-blind placebo-controlled trial of azithromycin to reduce mortality and improve growth in high-risk young children with non-bloody diarrhoea in low resource settings: the Antibiotics for Children with Diarrhoea (ABCD) trial protocol
DiscussionExpanding the treatment of acute watery diarrhoea in high-risk children to include an antibiotic may offer an opportunity to reduce deaths. These benefits may result from direct antimicrobial effects on pathogens or other incompletely understood mechanisms including improved nutrition, alterations in immune responsiveness or improved enteric function. The expansion of indications for antibiotic use raises concerns about the emergence of antimicrobial resistance both within treated children and the communities in which they live. ABCD will monitor antimicrobial resistance. The ABCD trial has important policy impli...
Source: Trials - January 13, 2020 Category: Research Source Type: clinical trials

A brief transdiagnostic psychological intervention for Afghan asylum seekers and refugees in Austria: a randomized controlled trial
DiscussionThis trial may provide substantial evidence for a brief transdiagnostic psychological intervention. Here, we intend to contribute to the treatment of mental health problems among Afghan refugees. The assessment of subjective experience with this treatment manual, as well as the evaluation of its clinical applicability, may optimize treatment acceptance and outcomes across a wide range of mental health problems among refugees.Trial registrationGerman Clinical Trials Register (DRKS) registration number:DRKS00016538. Universal Trial Number: U1111-1226-3285. Registered on January 7, 2019.https://www.drks.de/drks_web/...
Source: Trials - January 9, 2020 Category: Research Source Type: clinical trials

Measurement of cerebrovascular reserve by multimodal imaging for cerebral arterial occlusion or stenosis patients: protocol of a prospective, randomized, controlled clinical study
AbstractBackgroundCerebrovascular reactivity (CVR) is the change in cerebral blood flow in response to a vaso-active stimulus, and may assist the treatment strategy of ischemic stroke. However, previous studies reported that a therapeutic strategy for stroke mainly depends on the degree of vascular stenosis with steady-state vascular parameters (e.g., cerebral blood flow and CVR). Hence, measurement of CVR by multimodal imaging techniques may improve the treatment of ischemic stroke.Methods/designThis is a prospective, randomized, controlled clinical trial that aimed to examine the capability of multimodal imaging techniqu...
Source: Trials - January 8, 2020 Category: Research Source Type: clinical trials

Pilates and dance to patients with breast cancer undergoing treatment: study protocol for a randomized clinical trial – MoveMama study
DiscussionIn view of the high prevalence of breast cancer among women, the implementation of a specific protocol of Pilates solo and belly dancing for patients with breast cancer is important, considering the necessity to improve their physical and psychological quality of life. Pilates solo and belly dancing are two types of physical activity that involve mental and physical concentration, music, upper limb movements, femininity, and social involvement. An intervention with these two physical activities could offer options of supportive care to women with breast cancer undergoing treatment, with the aim being to improve p...
Source: Trials - January 7, 2020 Category: Research Source Type: clinical trials

Health Pregnancy, Healthy Baby: testing the added benefits of pregnancy ultrasound scan for child development in a randomised control trial
AbstractBackgroundThe 2016 World Health Organization Antenatal Guidelines and the 2015 South African Maternal and Child Health Guidelines recommend one early antenatal ultrasound scan to establish gestational age and to detect multiple pregnancies and fetal abnormalities. Prior research indicates that ultrasound scan can also increase parental –fetal attachment. We aim to establish whether, compared to routine care, messages to promote parental attachment and healthy child development, conducted during one or two pregnancy ultrasound scans, improve early child development and growth, exclusive breastfeeding, parental...
Source: Trials - January 6, 2020 Category: Research Source Type: clinical trials

Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
Conditions:   Common Mental Disorders;   Alcohol Use Disorder Interventions:   Diagnostic Test: GHQ-12;   Diagnostic Test: WHO AUDIT (World Health Organization- Alcohol Use Disorders Inventory Tool) Sponsor:   King's College London Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 18, 2019 Category: Research Source Type: clinical trials