Theta-burst rTMS in schizophrenia to ameliorate negative and cognitive symptoms: study protocol for a double-blind, sham-controlled, randomized clinical trial
DiscussionThis is a double-blind, sham-controlled, randomized medical device study to assess the efficacy and safety of an augmented theta-burst rTMS treatment in schizophrenia. We hypothesize that social cognition and negative symptoms of patients on active therapy will improve significantly compared to patients on sham treatment.Trial registrationThe study protocol is registered at “ClinicalTrials.gov” with the following ID: NCT05100888. All items from the World Health Organization Trial Registration Data Set are registered. Initial release: 10/19/2021. (Source: Trials)
Source: Trials - April 17, 2024 Category: Research Source Type: clinical trials

The World Health Organization Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns (ACTION-III) Trial: study protocol for a multi-country, multi-centre, double-blind, three-arm, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at high probability of late preterm birth in hospitals in low- resource countries
DiscussionThis trial will evaluate the benefits and possible harms of ACS when used in women likely to have a late preterm birth. It will also evaluate a lower-dose ACS regimen based on literature from pharmacokinetic studies. The results of this trial will provide robust critical evidence on the safe and appropriate use of ACS in the late preterm period internationally.Trial registrationISRCTN11434567. Registered on 7 June 2021. (Source: Trials)
Source: Trials - April 12, 2024 Category: Research Source Type: clinical trials

Study protocol for a pragmatic randomised controlled trial of comparing enhanced acceptance and commitment therapy plus (+) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors ’ Rehabilitation Evaluation after CANcer (SURECAN) trial
DiscussionTo date, there have been no robust trials reporting both clinical and cost-effectiveness of an ACT based intervention for people with low QoL after curative cancer treatment in the UK. We will provide high quality evidence of the effectiveness and cost-effectiveness of adding ACT+ to usual aftercare provided by the NHS. If shown to be effective and cost-effective then commissioners, providers and cancer charities will know how to improve QoL in cancer survivors and their families.Trial registrationISRCTN:ISRCTN67900293. Registered on 09 December 2019.All items from the World Health Organization Trial Registration...
Source: Trials - April 2, 2024 Category: Research Source Type: clinical trials

Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya —individually randomised superiority trial
This study seeks to gauge the potency of g-IPT for women with PND in two LMICs.MethodsThis multi-site randomised controlled trial is a continuation of two preceding phases —conceptual mapping and a feasibility study executed in Lebanon and Kenya. Insights gleaned from these phases underpin this comprehensive RCT, which contrasts the efficacy and cost-effectiveness of high-quality standard care (HQ-SC) augmented with g-IPT against HQ-SC in isolation. The trial, chara cterised as an individually randomised superiority assessment, targets women with postnatal depression in Beirut, Lebanon, and Nairobi, Kenya. It aims to det...
Source: Trials - March 26, 2024 Category: Research Source Type: clinical trials

The effect of UNIMMAP multiple micronutrient supplements versus iron-folic acid and placebo in anemia reduction among women of reproductive age in Kebribeyah Woreda, Somali Regional State, Ethiopia: a study protocol for a community-based individual RCT
DiscussionThe World Health Organization (WHO) added UNIMMAP-MMS to its essential medicine lists in 2021 but recommended rigorous study. Several factors in addition to inadequate intakes of iron and folic acid contribute to the high prevalence of anemia among WRA in the Somali region. The findings of this study will provide evidence on the effect of UNIMMAP-MMS and IFA on Hb concentrations and anemia prevalence among anemic WRA.Trial registrationClinicalTrials.gov NCT05682261. Registered on January 12, 2023. (Source: Trials)
Source: Trials - March 6, 2024 Category: Research Source Type: clinical trials

Efficacy of chlorfenapyr-pyrethroid and piperonyl butoxide-pyrethroid long-lasting insecticidal nets (LLINs) compared to pyrethroid-only LLINs for malaria control in C ôte d’Ivoire: a three group, cluster randomised trial
This study conducted in C ôte d’Ivoire will evaluate the efficacy on epidemiological and entomological outcomes of (1) the control arm: MAGNet® LN, which contains the pyrethroid, alpha-cypermethrin, (2) VEERALIN® LN, a net combining the synergist PBO and alpha-cypermethrin, and (3) Interceptor® G2 LN, which incorporate s chlorfenapyr and alpha-cypermethrin, two adulticides with different mechanisms of action. A total of 33 villages with an average of 200 households per village will be identified, mapped, and randomised in a ratio of 1:1:1. Nets will be distributed at a central point following national guidelines w it...
Source: Trials - February 28, 2024 Category: Research Source Type: clinical trials

Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda
DiscussionCHANGE aims to address alcohol misuse and psychological distress with male refugees in a humanitarian setting. If it is proven to be effective, it can help fill an important under-researched gap in humanitarian service delivery.Trial registrationISRCTN ISRCTN10360385. Registered on 30 January 2023. (Source: Trials)
Source: Trials - February 27, 2024 Category: Research Source Type: clinical trials

Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania
Conditions: Penile Infection; Penile Haematoma; Penile Bleeding; Deformity Interventions: Device: ShangRing Sponsors: IntraHealth International; Ministry of Health, Tanzania; President Office Regional Administration and Local Government, Tanzania; Centers for Disease Control and Prevention; Jhpiego; World Health Organization Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 22, 2024 Category: Research Source Type: clinical trials

World Health Organization (WHO) , COVID19 Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt
Conditions: Mucormycosis; Rhinocerebral (Etiology); COVID-19 Interventions: Procedure: debridment Sponsors: Nasser Institute For Research and Treatment Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 20, 2024 Category: Research Source Type: clinical trials

Registry of Acute Myocardial Infarction
Conditions: Myocardial Infarction, Acute Sponsors: Tomsk National Research Medical Center of the Russian Academy of Sciences; World Health Organization Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 9, 2024 Category: Research Source Type: clinical trials

To Assess the Impact of theERAS Consensus on Patients With Endoscopic Pituitary Tumor Surgery
Conditions: Enhanced Recovery After Surgery; Pituitary Tumor; Postoperative Complications Interventions: Diagnostic Test: Malnutrition Universal Screening Tool; Device: TIB Olfactory Test Device; Diagnostic Test: Apfel Score for Postoperative nausea and vomiting; Diagnostic Test: The American Society of Anesthesiologists (ASA) Physical Status Classification; Behavioral: Short Form-36; Behavioral: World Health Organization Quality of Life questionnaire (WHOQOL-BREF); Behavioral: BDI-II(Beck Depression Inventory-II); Behavioral: ERAS Patient Satisfaction Questionnaire(ERAS-PSQ); Behavioral: Quality of Recovery-40(QoR-40) Spo...
Source: ClinicalTrials.gov - January 24, 2024 Category: Research Source Type: clinical trials

Hepatitis C Virus Self-testing (HCVST) in Sexual and Gender Minorities in Rio de Janeiro
Conditions: Hepatitis C Interventions: Diagnostic Test: Hepatitis C virus self-test (oral fluid HCVST); Diagnostic Test: Hepatitis C virus self-test (blood-based HCVST) Sponsors: Oswaldo Cruz Foundation; World Health Organization; UNITAID Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 12, 2024 Category: Research Source Type: clinical trials

Vitamin E-enriched medium cross-linked polyethylene in total knee arthroplasty (VIKEP): clinical outcome, oxidation profile, and wear analysis in comparison to standard polyethylene —study protocol for a randomized controlled trial
DiscussionThe comparison between MXE and the standard gliding surface in this study will provide clinical data to confirm preceding biomechanical results in vivo. It is assumed that material-related differences will be identified, i.e., that the new material will be less sensitive to wear and creep. This may become obvious in biomechanical analyses of retrieved implants from revised patients and in radiologic analyses.Trial registrationClinicalTrials.gov, NCT04618016. Registered 27 October 2020,https://clinicaltrials.gov/study/NCT04618016?term=vikep&checkSpell=false&rank=1.All items from the World Health Organizati...
Source: Trials - January 5, 2024 Category: Research Source Type: clinical trials

Effect of denosumab on glucose metabolism in postmenopausal osteoporotic women with prediabetes: a study protocol for a 12-month multicenter, open-label, randomized controlled trial
This study aims to provide evidence on the efficacy of denosumab on glucose metabolism in postmenopausal women with osteoporosis and prediabetes. The results derived from this clinical trial may provide insight into the potential of denosumab in preventing T2D in high-risk populations.Trial registrationThis study had been registered in the Chinese Clinical Trials Registry. Registration number: ChiCTR2300070789 on April 23, 2023.https://www.chictr.org.cn. (Source: Trials)
Source: Trials - December 18, 2023 Category: Research Source Type: clinical trials

Physical Activity Coaching in Patients With Post-COVID-19
Conditions: Post-COVID-19 Syndrome Interventions: Behavioral: Self-monitoring; Behavioral: Goal setting and review; Behavioral: Education; Behavioral: Feedback; Behavioral: Contact; Behavioral: Exercise; Behavioral: Report; Behavioral: Social support; Behavioral: Group activities; Behavioral: World Health Organization recommendations for being physically active Sponsors: University of Alcala; Professional College of Physiotherapists of the Community of Madrid Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 12, 2023 Category: Research Source Type: clinical trials