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NCT ID: NCT05192265 Completed - Clinical trials for Plasmodium Falciparum Malaria

Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine

Start date: May 20, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

In Nigeria, malaria is the commonest reason for outpatient clinic attendance in childhood and is responsible for about 20% of childhood deaths. The emergence of strains of P. falciparum resistant to chloroquine and sulfadoxine-pyrimethamine led to severe worsening of morbidity and mortality from malaria. As a result of resistance to previously used monotherapy, the World Health Organization (WHO) in 2001, recommended that malaria-endemic countries experiencing drug-resistant malaria infection adopt combination therapy. Artemisinin-based combination therapy (ACT) is preferred to the non-ACT combination. In this randomized open-label clinical trial, the safety and efficacy of pyronaridine-artesunate and artemether-lumefantrine in the treatment of malaria among children aged 3 to 120 months who have microscopically confirmed symptomatic Plasmodium falciparum malaria were compared. The study was carried out at the Oni Memorial Children's Hospital, Ring Road Ibadan. One hundred and seventy-two children between 3 and 120 months who meet the inclusion criteria will be enrolled after obtaining written or witnessed signed informed consent from the parents or guardian. A detailed history and physical examination were carried out on each enrollee. Finger prick blood samples were taken from each enrolee for thick blood smear for malaria parasite, haematocrit, and blood spots on filter paper. Five millilitres of venous blood will be taken from an arm vein for baseline liver function tests, creatinine, and random blood glucose on days 0, 3, 7 and 28. Enrollees were randomized into one of two groups. Group one received pyronaridine-artesunate while group two received artemether-lumefantrine at standard doses. Enrollees were seen daily from days 0-3, and on days 7, 14, 21 and 28. Study drugs were administered supervised at standard dosage on days 0, 1, and 2. History taking, physical examination and blood smears were done at each contact time. Special attention will be paid to adverse effects. Parasite clearance time, fever clearance time and cure rates were compared between the two groups.

NCT ID: NCT05175794 Not yet recruiting - Tuberculosis Clinical Trials

Triage Test for All Oral DR-TB Regimen (TRiAD Study)

Start date: February 1, 2022
Phase:
Study type: Observational

A Phase 4 operational study to assess the effectiveness, feasibility, acceptability, and cost effectiveness of the GeneXpert MTB/XDR (Xpert XDR; Cepheid) assay for rapid triage-and-treatment of DR-TB-A multi-centre, multi-country prospective cohort study

NCT ID: NCT05142254 Not yet recruiting - Clinical trials for Priapism Due to Sickle Cell Disease

A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study

PIN
Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

To conduct a randomized controlled internal pilot feasibility trial for the prevention of recurrent ischemic priapism referred to as the Priapism in Nigeria (PIN) trial. The study team will enroll a minimum of 30 participants and a maximum of 200 participants. Study investigators hypothesize that hydroxyurea therapy combined with tadalafil is superior to a combination of hydroxyurea and placebo in the prevention of recurrent ischemic priapism.

NCT ID: NCT05102097 Recruiting - Clinical trials for Chronic Low Back Pain

Effectiveness of Treadmill Walk on Chronic Low Back Pain

Start date: August 16, 2021
Phase: N/A
Study type: Interventional

Chronic low back pain is a common health problem with a multifactorial impact on core muscle function as well as causing pain, functional disability and decrease in quality of life, this occur due to the reduction in the physical activity level of the individual causing atrophy and inhibition of the core muscle affecting the stability of the spine

NCT ID: NCT05097391 Recruiting - Stroke Clinical Trials

Effects of Paretic Lower Limb Loading During Overground Training

Start date: August 2, 2021
Phase: N/A
Study type: Interventional

The ability to walk properly after stroke is a highly desired goal among stroke survivors and their relatives; because the gait is believed as a yardstick for measuring recovery, too much time is spent on gait re-education and recovery of mobility during rehabilitation. Despite rehabilitation efforts, almost 80% of survivors still experience impaired walking function and a further 22% do not regain any walking function at all.

NCT ID: NCT05044689 Recruiting - Breast Cancer Clinical Trials

Case Control Study to Identify Modifiable Risk Factors for Colorectal and Breast Cancer in Nigeria

Start date: April 12, 2018
Phase:
Study type: Observational

This project is a case-control study which seeks to identify modifiable risk factors for breast and colorectal cancer in Nigeria. Both cases and controls will be required to complete a risk factor questionnaire which contains information about their diet, physical activity, past medical history and life style factors. They will also be required to provide information on their body composition through the use of a bioimpedance machine which measures the body mass index, fat and total body water percentage. Based on the existing ARGO platform where a current colorectal cancer study is going on, approximately 400 patients with a prior diagnosis or a new diagnosis will be recruited into this study. Comparatively, we will select our 400 controls from two groups of participants who are free of cancer and gastrointestinal diseases.

NCT ID: NCT05031819 Not yet recruiting - Blood Pressure Clinical Trials

Managing Hypertension Among People Living With HIV

MAP-IT
Start date: April 2022
Phase: N/A
Study type: Interventional

The Managing Hypertension Among People Living with HIV: An InTegrated Model (MAP-IT) a stepped wedge, cluster-randomized controlled trial to evaluate the effect of practice facilitation (PF) on the integration of a Task-Shifting Strategy for hypertension (HTN) control (TASSH) into HIV care for management of HTN in people living with HIV (PLWH). The study will recruit 960 PLWH across 30 primary health centers (PHCs) in Akwa Ibom State (32 patients/PHC).

NCT ID: NCT04976179 Recruiting - Clinical trials for Iron Deficiency Anemia of Pregnancy

Iron Infusion Into a Vein Compared to Iron Tablet Taken by Mouth for Treating Iron Deficiency Anemia in Pregnancy (IVON)

IVON
Start date: August 9, 2021
Phase: Phase 3
Study type: Interventional

Background: Anaemia in pregnancy is a public health burden with high incidence in Africa. Currently high dose oral iron is recommended for treatment of mild to moderate anaemia and blood transfusion for severe anaemia. The high dose oral iron is often poorly tolerated and associated with several side effects. Various parenteral iron preparations are now available for treatment of iron deficiency anaemia (IDA). The earliest of these, iron dextran is not commonly used because of its potential to cause anaphylactic reactions. Newer preparations have been found to be safer and their use for treatment of IDA is currently being evaluated. Objective: This study sought out to compare the effectiveness of intravenous ferric carboxymaltose (intervention) versus oral ferrous sulphate (control) for treating IDA in pregnancy and to compare the tolerability, safety and the cost-effectiveness of intravenous versus oral iron among pregnant Nigerian women with moderate and severe IDA at 20-32 weeks' gestation. Methodology: This study will be a hybrid Type 1 effectiveness-implementation design. 1056 eligible and consenting pregnant women with anaemia at 20 - 32 weeks gestation will be recruited. They will be randomized into either of 2 groups. Group A will have intravenous ferric carboxymaltose 20mg/kg to a maximum of 1000mg in 100mls of normal saline infusion over 15 - 20 minutes at enrolment. Group B will have oral ferrous sulphate 200mg (65mg elemental iron) thrice daily from enrolment till delivery. They will be followed up through delivery and until 6 weeks post partum. Their haemoglobin concentration, full blood count, serum ferritin and serum transferrin will be assayed at specific intervals using standard laboratory techniques. Depression will be assessed at each visit using Edinburg Postnatal Depression Scale. Cost effectiveness analysis will also be done at each visit. The primary outcome measure will be incidence of maternal anaemia and rise in haemoglobin level. Secondary outcome measures will include safety and tolerability of trial drugs, severe maternal events, incidence of infant low birth weight and incidence of depression. Statistical analysis will be done using STATA version 16.0 statistical software (STATACorp, Texas, USA).

NCT ID: NCT04969250 Recruiting - Covid19 Clinical Trials

Vaccination for Recovered Inpatients With COVID-19 (VATICO)

Start date: August 25, 2021
Phase: Phase 4
Study type: Interventional

In this Phase 4, open-label trial, participants of the ACTIV-3/TICO clinical trial (NCT04501978) at selected study sites who receive certain pre-specified, blinded investigational agents or placebo as part of that trial and who have since achieved sustained recovery from COVID-19 and meet certain criteria, including not having received a COVID-19 vaccination since enrollment, will be randomized to one of four groups to receive the Moderna mRNA-1273 or the Pfizer BNT162b2 vaccine (mRNA vaccines). No "dummy/placebo" vaccine will be used. Choice of Moderna or Pfizer vaccine is determined based on availability at the site. The choice is individual, although participants vaccinated twice should receive the same type of vaccine when receiving two injections. The study's objective is to evaluate if the vaccine is best administered early or deferred after recovery, and whether one injection provides comparable immune response to a two injection course of vaccination. Participants will remain blinded to the interventions received in the ACTIV-3/TICO study, however allocation to the timing of vaccination and to one or two vaccinations in this (VATICO) study is not blinded.

NCT ID: NCT04950153 Recruiting - Clinical trials for Adolescent HIV Infection

Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase

iCARE
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

Combination interventions with mHealth and Peer Navigation components will be evaluated in a randomized, stepped wedge trial among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study findings will demonstrate whether or not the combination interventions for HIV testing and linkage to care and for HIV treatment outcomes, which were found to be efficacious in our prior pilot UG3 trial, will remain efficacious if scaled as proposed in this UH3 trial, across multiple sites.