LLIN Evaluation in Uganda Project (LLINEUP) – Impact of long-lasting insecticidal nets with, and without, piperonyl butoxide on malaria indicators in Uganda: study protocol for a cluster-randomised trial
DiscussionPBO LLINs are a promising new tool to reduce the impact of pyrethroid resistance on malaria control. The World Health Organization has issued a preliminary endorsement of PBO LLINs, but additional epidemiological evidence of the effect of PBO LLINs is urgently needed. The results of this innovative, large-scale trial embedded within a routine national distribution campaign will make an important contribution to the malaria control policy in Uganda and throughout Africa, where pyrethroid resistance in malaria vectors has increased dramatically. This model of evaluation could be a paradigm for future assessment of ...
Source: Trials - June 3, 2019 Category: Research Source Type: clinical trials

Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial
DiscussionThis trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra-, and postpartum care for women with chronic disease is founded.Trial registrationClinicalTrials.gov,NCT03511508. Registered April 27, 2018. (Source: Trials)
Source: Trials - May 28, 2019 Category: Research Source Type: clinical trials

Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients ’ treatment adherence via electronic monitors and an app versus usual care in Tibet
In this study we will pilot and evaluate the effectiveness of using new electronic monitors (e-monitors) and a smartphone app to improve treatment adherence among new pulmonary TB patients in Tibet.MethodsWe will use a multicentre, parallel-group, individually randomised controlled, superiority trial with blinded outcome evaluation and unblinded treatment. We will randomise new pulmonary TB outpatients (aged ≥ 15 years old and free from communication impairment) from Shigatse, Tibet to either the intervention or control arm in a 1:1 ratio at the time of their diagnosis. All patients will be treated according to t...
Source: Trials - May 16, 2019 Category: Research Source Type: clinical trials

Efficacy of the In2Care ® auto-dissemination device for reducing dengue transmission: study protocol for a parallel, two-armed cluster randomised trial in the Philippines
DiscussionFor decades, it has been commonly accepted that an integrated approach to mosquito control is required. The World Health Organization (WHO) Global Strategic Framework for Integrated Vector Management recommends a range of interventions, in combination, to increase control impact to reduce transmission. This efficacy trial of the first commercial product using the AD approach will be informative in assessing the general utility of AD in reducing not only adult vector densities but, more importantly, reducing the incidence of dengue. The AD technique may complement source reduction and larviciding campaigns by more...
Source: Trials - May 14, 2019 Category: Research Source Type: clinical trials

The effects of two early parenting interventions on child aggression and risk for violence in Brazil (The PI Á Trial): protocol for a randomised controlled trial
DiscussionThe Pelotas  Trial of Parenting Interventions for Aggression (PIÁ) aims to evaluate the impact of two early parenting interventions on child aggression and several other key risk factors for the development of violence, including aspects of parenting and child cognition and socio-emotional functioning. The st udy is being carried out in a LMIC context where violence constitutes a major social and health burden. Since the two interventions are brief and, with modest levels of training, readily deliverable in LMIC settings, a demonstration that they benefit parenting and reduce risk factors for violence...
Source: Trials - May 2, 2019 Category: Research Source Type: clinical trials

A randomized controlled trial of an intervention delivered by mobile phone text message to increase the acceptability of effective contraception among young women in Palestine
The objective of this trial was to estimate the effect of a contraceptive behavioral intervention delivered by mobile phone text message on young Palestinian women ’s attitudes towards effective contraception.MethodsWe conducted a randomized controlled trial among women aged 18 –24 years living in the West Bank, who were not using an effective method of contraception. The intervention group received zero to three messages per day (113 messages for female-not married and 120 messages for female-married) for 120 days. The control group received 16 messages over 120 d ays about trial participa...
Source: Trials - April 23, 2019 Category: Research Source Type: clinical trials

The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial
This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19 –59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary o utcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as me...
Source: Trials - April 15, 2019 Category: Research Source Type: clinical trials

Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials
ConclusionThis study demonstrates that none of the CTRs of ICMJE and WHO platforms has adequate fields to establish that the source of post-marketing IMPs is of assured quality. This is astonishing given the lengthy requirements in WHO and ICMJE guidelines. Considering the relation between IMP quality and safety of clinical trial participants, the gap of quality assurance fields should be bridged at CTRs concurrently to adjustments of WHO and ICMJE guidelines on CTRs. Specifically, IMP quality testing addressing issues on IMP appearance, impurities, microbial contamination, and dosing should be conducted and reported befor...
Source: Trials - April 11, 2019 Category: Research Source Type: clinical trials

Evaluation of Visual Motor Development in Children With Premature Retinopathy
Conditions:   Premature Retinopathy;   Visual Impairment;   Motor Delay Interventions:   Diagnostic Test: Snellen Test;   Diagnostic Test: Autorefractometer;   Diagnostic Test: Titmus Stereo Fly Test;   Diagnostic Test: Optical Kohlerans Tomography;   Behavioral: Investigation of Visual Motor Integration;   Behavioral: Peabody Developmental Motor Scales - II;   B ehavioral: World Health Organization Quality of Life - BREF;   Behavioral: State - Trait Anxiety In...
Source: ClinicalTrials.gov - March 6, 2019 Category: Research Source Type: clinical trials

Evaluation of Visual - Motor Development in Children With Retinopathy of Prematurity
Conditions:   Premature Retinopathy;   Visual Impairment;   Motor Delay Interventions:   Diagnostic Test: Snellen Test;   Diagnostic Test: Autorefractometer;   Diagnostic Test: Titmus Stereo Fly Test;   Diagnostic Test: Optical Kohlerans Tomography;   Behavioral: Investigation of Visual Motor Integration;   Behavioral: Peabody Developmental Motor Scales - II;   B ehavioral: World Health Organization Quality of Life - BREF;   Behavioral: State - Trait Anxiety In...
Source: ClinicalTrials.gov - March 6, 2019 Category: Research Source Type: clinical trials

Evaluation of Visual Motor Development in Children With Premature Retinopathy
Conditions:   Premature Retinopathy;   Visual Impairment;   Motor Delay Interventions:   Diagnostic Test: Snellen Test;   Diagnostic Test: Autorefractometer;   Diagnostic Test: Titmus Stereo Fly Test;   Diagnostic Test: Optical Kohlerans Tomography;   Behavioral: Investigation of Visual Motor Integration;   Behavioral: Peabody Developmental Motor Scales - II;   B ehavioral: World Health Organization Quality of Life - BREF;   Behavioral: State - Trait Anxiety In...
Source: ClinicalTrials.gov - March 6, 2019 Category: Research Source Type: clinical trials

Sentinel lymph node excision with or without preoperative hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) in melanoma: study protocol for a multicentric randomized controlled trial
We present a multicenter, unblinded superiority randomized controlled trial to compare SPECT/CT-aided SLNE versus standard SLNE in melanoma patients.DiscussionThe primary efficacy endpoint is distant metastasis-free survival. Secondary endpoints comprise overall survival, disease-free survival, rate of local relapses within the follow-up period (false-negative rate of sentinel lymph node), number of positive sentinel lymph nodes (sensitivity, false-positive rate), complication rate, quality of life, quality-adjusted life years, inpatient days, and overall costs during hospital stays.Trial registrationClinicalTrials.gov,NCT...
Source: Trials - February 4, 2019 Category: Research Source Type: clinical trials

Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, multicenter, randomized, open-label clinical trial
This study is a phase II/III, multicenter, randomized, open-label clinical trial of non-inferiority design comparing a new regimen to the World Health Organization-endorsed conventional regimen for fluoroquinolone-sensitive MDR-TB. The control arm uses a conventional treatment regimen with second-line drugs including injectables for 20 –24 months. The investigational arm uses a new shorter regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for 9 or 12 months depending on time to sputum culture conversion. The primary outcome is the treatment success rate at 24 months after tre...
Source: Trials - January 16, 2019 Category: Research Source Type: clinical trials

Evaluation of an intensive education program on the treatment of tobacco-use disorder for pharmacists: a study protocol for a randomized controlled trial
DiscussionIf demonstrated to be effective, this education program will be considered as a model that Qatar and the Middle East region can apply to overcome the burden of tobacco-use disorder.Trial registrationClinicalTrials.gov, ID:NCT03518476. Registered on 8 May 2018. Version 1/22 June 2018. (Source: Trials)
Source: Trials - January 8, 2019 Category: Research Source Type: clinical trials

Levofloxacin versus placebo for the prevention of tuberculosis disease in child contacts of multidrug-resistant tuberculosis: study protocol for a phase III cluster randomised controlled trial (TB-CHAMP)
AbstractBackgroundMultidrug-resistant (MDR) tuberculosis (TB) presents a challenge for global TB control. Treating individuals with MDR-TB infection to prevent progression to disease could be an effective public health strategy. Young children are at high risk of developing TB disease following infection and are commonly infected by an adult in their household. Identifying young children with household exposure to MDR-TB and providing them with MDR-TB preventive therapy could reduce the risk of disease progression. To date, no trials of MDR-TB preventive therapy have been completed and World Health Organization guidelines ...
Source: Trials - December 20, 2018 Category: Research Source Type: clinical trials

Effect of a home-based exercise program on functional mobility and quality of life in elderly people: protocol of a single-blind, randomized controlled trial
DiscussionThe lack of scientific evidence demonstrating the benefits of semi-supervised home exercise on functional mobility and QoL in elderly people represents an obstacle to the development of guidelines for clinical practice and for policy-makers. The World Health Organization highlighted the importance of musculoskeletal health programs for elderly people, and the exercise program described in this protocol was designed to be viable, easy to implement, and inexpensive, and could be performed at the home of elderly subjects after receiving only guidelines and follow-up via periodic visits. Based on these facts, we hope...
Source: Trials - December 12, 2018 Category: Research Source Type: clinical trials

AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial
DiscussionA safe, sustainable and easy to administer regimen of L-AmB that is non-inferior to seven days of daily amphotericin B deoxycholate therapy may reduce the number of adverse events seen in patients treated with amphotericin B deoxycholate and shorten hospital admissions, providing a highly favourable and implementable alternative to the current WHO recommended first-line treatment.Trial registrationISRCTN,ISRCTN72509687. Registered on 13 July 2017. (Source: Trials)
Source: Trials - November 23, 2018 Category: Research Source Type: clinical trials

Decreasing the use of edible oils in China using WeChat and theories of behavior change: study protocol for a randomized controlled trial
This study aims to increase knowledge and awareness of the appropriate use of edible oils, thereby encouraging participants to change behaviour by decreasing the intake of unhealthy levels of edible oils. It will be the first intervention to investigate the use of edible oils in China through WeChat. We predict that receiving health education regarding edible oils through WeChat will substantially improve the knowledge and attitude of the respondents. The members of the intervention group will have increased awareness and will be willing to decrease their use of edible oils to remain healthy. Results of this study may prov...
Source: Trials - November 16, 2018 Category: Research Source Type: clinical trials

Exploring qualitative methods reported in registered trials and their yields (EQUITY): systematic review
ConclusionThe reported use of qualitative methods in registered trials has increased over time and worldwide. They are reportedly more frequent in high-income countries and in trials of behavioural and other interventions. Trialists and other stakeholders need to recognise the benefits of using qualitative methods in surgical, device and drug trials, and trials conducted in poorer countries. Moreover, they should seriously consider using qualitative methods in these trials. (Source: Trials)
Source: Trials - October 29, 2018 Category: Research Source Type: clinical trials

Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation
DiscussionSLATE II improves upon the SLATE I study by reducing the number of reasons for delaying ART initiation and allowing more patients with TB symptoms to start ART on the day  of diagnosis. If successful, SLATE II will provide a simple and streamlined approach that can readily be adopted in other settings without investment in additional technology.Trial registrationClinicalTrials.gov,NCT03315013. Registered on 19 October 2017. (Source: Trials)
Source: Trials - October 11, 2018 Category: Research Source Type: clinical trials

World Health Organization Recommends the Use of Bedaquiline in all Conventional Multidrug-Resistant Tuberculosis Treatment Regimens
Beerse, Belgium, August 17, 2018 – Johnson& Johnson today acknowledges the issuance of a “Rapid Communication” by the World Health Organization (WHO) describing key changes to treatment guidelines for multidrug- and rifampicin-resistant... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 17, 2018 Category: Pharmaceuticals Source Type: clinical trials

Caregiver Interventions for Developmental Delays in Young Kenyan Children
Conditions:   Child Development;   Parenting;   Cognitive Developmental Delay Intervention:   Behavioral: Mother groups using principles of UNICEF/World Health Organization's Care for Child Development Sponsors:   Indiana University;   National Institutes of Health (NIH) Enrolling by invitation (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 2, 2018 Category: Research Source Type: clinical trials

Simplifying the World Health Organization (WHO) Protocol for Hand Hygiene: me18Tschudin-Sutter
Condition:   Hand Hygiene Intervention:   Procedure: four sets of hand hygiene measurements per participant Sponsor:   University Hospital, Basel, Switzerland Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 17, 2018 Category: Research Source Type: clinical trials