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NCT ID: NCT04290975 Active, not recruiting - Epilepsy Clinical Trials

Bridging the Childhood Epilepsy Treatment Gap in Africa

BRIDGE
Start date: June 16, 2020
Phase: N/A
Study type: Interventional

About half of the world's children with epilepsy do not receive treatment - known as the epilepsy treatment gap - with significantly higher rates (67%-90%) in low- and middle-income countries (LMICs). We will conduct the first cluster-randomized clinical trial (cRCT) to determine the efficacy, implementation, and cost-effectiveness of a novel intervention shifting childhood epilepsy care to epilepsy-trained community health extension workers in an effort to close the epilepsy treatment gap. This research will provide information to help extend epilepsy treatment to children in LMICs and worldwide who suffer from untreated seizures.

NCT ID: NCT04285034 Completed - Lassa Fever Clinical Trials

Cardiovascular Function and Ribavirin PK/PD in Lassa Fever in Lassa Fever

Start date: November 26, 2019
Phase:
Study type: Observational

Arenaviruses are included in the World Health Organisation R&D Blueprint list of high priority pathogens, since this virus group includes several epidemic-prone highly pathogenic viruses for which there are inadequate diagnostic, therapeutic, and preventative interventions. Junin, Machupo, Guanarito, Sabia, Lujo, and Lassa virus can all cause a viral haemorrhagic fever with high case fatality in hospitalised cases. Lassa fever is the most common severe arenavirus disease and is endemic across many low and middle income countries in West Africa, with an estimated 37.7 million people in 14 countries living in areas at risk of Lassa virus. Despite the discovery of Lassa virus in 1972 and an estimated 300,000 cases and 5000-10,000 deaths annually, there remain gaps in our understanding of the natural history of disease and in the availability of evidence based interventions. The protocol has two components. Sites may implement one or both components. 1. Cardiovascular function in Lassa fever: Lassa fever in humans is often described in the literature as being characterized by vascular leak and shock in the terminal phase, this being the main pathway to death. Whilst animal data supports this, there are very limited data in humans. One of the main aims of this study therefore is to characterize cardiovascular function in patients with Lassa fever, with the ultimate goal of informing future trials of supportive or therapeutic strategies to improve vascular leak. 2. Ribavirin pharmacokinetics and pharmacodynamics: The recommended treatment for Lassa is ribavirin, but its efficacy has not been established in randomized controlled trials and its mechanism of action is not fully understood. There are very limited PK data on ribavirin in patients with Lassa fever and the optimal dose of ribavirin for an RCT has not been established. Furthermore, there are various hypothesized mechanisms of action of ribavirin, none of which have been investigated in humans with Lassa fever. Therefore, further aims of this study are to characterize the PK of ribavirin and ribavirin metabolites (RMP, RDP, RTP) in Lassa fever patients and to identify potential mechanisms of action ribavirin in Lassa fever. Understanding Ribavirin's mechanism of action in Lassa fever is important for the optimal design of a future RCT.

NCT ID: NCT04248881 Completed - Cancer Prevention Clinical Trials

Step up to Health, Nigeria! Impact of World Cancer Day Walk on Health Behaviors Among Nigerians

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

Cancer awareness is a critical element of cancer prevention and control. Creating public awareness on risk factors, preventative strategies, and the importance of early screening is the foundation upon which a cancer control program must be constructed. The purpose of this study is to describe the sociodemographic and risk factor distribution of the Abuja, Nigeria "World Cancer Day Walk" participants according to their motive for participating in the event (free cancer screening versus fun/activities), and secondarily, to investigate the impact of the event on educating attendees from the general population about cancer prevention and screening, in particular the importance of being physically active and maintaining a healthy body weight. Obesity is a known risk factor contributing to the development of cancer and NCD's.

NCT ID: NCT04242212 Recruiting - Induced Abortion Clinical Trials

Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion

Start date: May 19, 2019
Phase:
Study type: Observational

The goal of the study is to determine whether important clinical outcomes differ among women who access a misoprostol-only medication abortion regimen from a patent medicine vendor when compared with those who access it from a clinic.

NCT ID: NCT04234945 Recruiting - Infertility, Female Clinical Trials

Effect of Prophylactic Antibiotics for Hysterosalpingography on Post Procedure Morbidity

Start date: January 13, 2020
Phase: N/A
Study type: Interventional

The study will be a parallel randomised trial. There are two groups. The first group will be given prophylactic antibiotics before a procedure (hysterosalpingography) and the second group will be given a placebo(multivitamin). Outcomes will then be assessed.

NCT ID: NCT04222270 Recruiting - HIV Clinical Trials

Caregiver Peer Support and ART Adherence Among Children

CaPS
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Adherence for children living with HIV is a by-proxy phenomenon dependent on caregivers (parents, relatives or unrelated guardians) who may or may not be living with HIV. The complexity of paediatric formulations and dosing for ART regimens often poses challenges for caregivers, making ART administration and achievement of viral suppression quite a difficult task for young children. Peer support for caregivers presents a potentially feasible and impactful approach to improve ART adherence and facilitate achievement of viral suppression among children. However, there is a scarcity of robust evidence on the impact of caregiver support as a treatment adherence strategy for children. The study is a two-arm cluster randomized controlled trial that includes 78 unsuppressed children living with HIV (0-10 years old) and their caregivers at six cluster sites in Nigeria. It will: - Explore facilitators and barriers to ART adherence among young children to develop a caregiver peer mentor training curriculum and interventional programme. - Test the impact of caregiver peer support, a locally adapted behavioural intervention, to improve adherence and promote achievement of viral suppression among children. The intervention will target caregivers of unsuppressed children, measuring outcomes at child level after 12 months of follow up. The intervention arm will receive structured caregiver-to-caregiver peer support while the control arm will receive routine standard of care with no such support. The researchers will compare viral suppression and ART drug-pickup rates for children living with HIV at specific time points for both arms.

NCT ID: NCT04218084 Active, not recruiting - Sickle Cell Disease Clinical Trials

Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease

HOPE Kids 2
Start date: November 11, 2020
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, randomized, double-blind, placebo-controlled study of voxelotor in pediatric participants, aged ≥ 2 to < 15 years old, with Sickle Cell Disease. The primary objective is to evaluate the effect of voxelotor on the TCD (Transcranial Doppler Ultrasound) measurements in SCD participants in this age range.

NCT ID: NCT04207645 Terminated - Acute Appendicitis Clinical Trials

Modification and Validation of the RIPASA Score for Diagnosis of Acute Appendicitis

MODRIS
Start date: November 1, 2019
Phase:
Study type: Observational

Purpose: The diagnostic approach of patients with acute appendicitis (AA) remains debated. A number of clinical prediction rules (CPRs) exist for diagnosis of AA with variable sensitivity, specificity, and diagnostic accuracy, in different ethnic populations. Among these, the Raja Isteri Pengiran Anak Saleha Appendicitis (RIPASA) score was shown to have a high sensitivity though with a poor specificity. The aim of this study is to modify and validate the RIPASA score in 4 distinct ethnic groups, and to compare the performance of the new score to the original RIPASA and Alvarado scores. Methods: This multicenter, international prospective observational study will be conducted in 6 countries, and will include all eligible patients referred to surgical specialists with acute right iliac fossa pain or suspected AA in the participating centres. Patients will be categorized into 4 ethnic groups based on the country of origin. The modified RIPASA score will be developed in one ethnic group, and along with the original RIPASA and Alvarado scores, will be externally validated in the other 3 ethnic groups. Management of patients will be prospectively evaluated in a standardized manner. The focus of the analysis will be on the performance of the 3 CPRs in different ethnic and gender groups using receiver operating characteristic curve analyses. Discussion: We expect this study to develop a CPR that can assist surgeons and surgical residents to early identify patients with AA in the busy clinical and low-resource settings, and to optimize the diagnostic value of the RIPASA and Alvarado scores in different ethnic and gender groups.

NCT ID: NCT04193241 Recruiting - Pleural Effusion Clinical Trials

Suturing With U-Technique Versus Un-Reapproximated Wound Edges During Removal of Closed Thoracostomy Tube Drain

SUTURE
Start date: January 2, 2020
Phase: N/A
Study type: Interventional

The study will be carried out by the principal investigator and his team at the Division of Cardiovascular and Thoracic Surgery of the Department of Surgery, College of Medicine, University of Ibadan and the University College Hospital, Ibadan (UCH), which is the Teaching Hospital of the Medical College.The study sets out to prospectively compare the early and long-term outcomes between the use of purse-string (suturing U-technique) and Un-reapproximated thoracostomy wound edges (Occlusive adhesive-absorbent dressing application) at the time of removal of thoracostomy tube drain in patients who have had chest tube insertion.

NCT ID: NCT04188509 Recruiting - Sickle Cell Disease Clinical Trials

Open-Label Extension of Voxelotor

Start date: November 18, 2019
Phase: Phase 3
Study type: Interventional

Open-label extension study of voxelotor for participants with Sickle Cell Disease who have participated in voxelotor clinical trials.