Henry Mugerwa
ID: UNCST-2019-R000420
|
A phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises
REFNo: HS5274ES
Primary Objective: To compare the efficacy of 5 mg/kg of crizanlizumab versus placebo, with or without hydroxyurea/hydroxycarbamide, on the annualized rate of VOCs* that are HCPmanaged (including VOCs leading to
management at a health care facility or those managed via remote consultation) over the planned 52-week treatment period in SCD
patients aged 12 years and older with a history of frequent VOCs (4-12 events in 12 months prior to the screening visit).
Secondary Objective: Key secondary objective:
To compare the efficacy of 5 mg/kg of
crizanlizumab versus placebo, with or without
hydroxyurea/hydroxycarbamide, on the
annualized rate of all VOCs including VOCs that are HCP-managed (including VOCs leading to
management at a health care facility or those managed via remote consultation) and VOCs that are self-managed without recommendations from HCP during the event over the planned 52-week treatment period in SCD patients aged 12 years and older with a history of frequent VOCs (4-12 events in the 12 months prior to the screening visit).
To evaluate the annualized rate of VOCs by type of management between treatment arms over the planned 52-week treatment period:
VOCs that are HCP-managed at a health
care facility
• VOCs that are HCP-managed via remote
consultation
• VOCs that are self-managed without
recommendations from HCP during the
event
• VOCs that are HCP-managed via remote
consultation or self-managed without
recommendations from HCP during the
event
• To evaluate the time to first VOC that is HCPmanaged (including VOCs leading to
management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the proportion of participants free from VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the duration of VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) between treatment arms over the planned 52-week treatment period.
To evaluate the safety and immunogenicity of crizanlizumab 5 mg/kg over the 2-year study
period.
To explore the efficacy of crizanlizumab 5 mg/kg over the 2-year study period.
To explore the proportion of VOCs that are selfmanaged without recommendations from HCP during the event, versus VOCs that are HCP-managed (including VOCs leading to
management at a health care facility or those managed via remote consultation) between treatment arms over the planned treatment period of 52 weeks.
To explore the proportion of VOCs that are HCP-managed via remote consultation versus VOCs that are HCP-managed at a healthcare facility between treatment arms over the planned 52-week treatment period.
To explore the incidence rates of all VOCs,
VOCs that are HCP-managed at a healthcare
facility, VOCs that are HCP-managed via remote consultation, VOCs that are HCP-managed,VOCs that are self-managed without
recommendations from HCP during the event,
VOCs that are HCP-managed via remote
consultation or self-managed without
recommendations from HCP during the event, by treatment arm.
To explore quality of life in each treatment arm (ASCQ-Me Short Forms: emotional impact, sleep impact, and joint stiffness).
To explore healthcare facility resource utilization (inpatient hospital admission, emergency room visit, urgent care/clinic visit, infusion center visit)between treatment arms over
the planned 52-week treatment period.
To explore the pharmacokinetics (PK) profile of crizanlizumab at 5 mg/kg.
To explore the pharmacodynamics (PD) (Pselectin inhibition) of crizanlizumab at 5 mg/kg.
To explore biomarkers [p-selectin (free and
total)] and CRP].
To explore exposure-response relationship.
|
Uganda |
2025-04-02 8:43:56 |
2028-04-02 |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Taremwa Danison Danison
ID: UNCST-2024-R002981
|
AN OPTIMIZED ENSEMBLE DEEP LEARNING MODEL FOR MAIZE YIELD PREDICTION
REFNo: SIR375ES
General Objective of the Study
The general objective of the study will be to develop an optimized ensemble deep learning model to improve the accuracy of maize yield prediction, thereby enhancing decision-making by stakeholders in the agriculture sector.
Specific Objectives of the Study
i. To investigate the challenges of the current yield forecasting models and remote sensing technologies that will be used to generate variables for predicting maize yields using remote sensing data.
ii. To design and develop an optimized CNN-LSTM model using Bayesian approaches for the prediction of maize yields in Uganda.
iii. To evaluate the performance of the developed model for maize yield estimation.
|
Uganda |
2025-04-02 8:32:18 |
2028-04-02 |
Engineering and Technology |
Non-Clinical Trial |
Degree Award |
|
Moses Sembatya Nixon
ID: UNCST-2024-R015771
|
Baseline Study of Norms and Behavioral Drivers of Child Marriage and Female Genital Mutilation in Uganda
REFNo: SS3765ES
This study aims to provide crucial insights into the prevalence, drivers, and consequences of child marriage (CM) and female genital mutilation (FGM) in Uganda through a comprehensive baseline study. By assessing social norms, knowledge, attitudes, and practices related to CM and FGM, the study seeks to inform targeted interventions and policy decisions.
|
Uganda |
2025-04-02 10:33:36 |
2028-04-02 |
Social Science and Humanities |
Non-Clinical Trial |
Non-degree Award |
|
Rogers Ssebunya
ID: UNCST-2025-R016712
|
Supporting Health System Readiness and Quality for Scaled Delivery of Self-Injectable Contraception: The Delivering Innovation in Self-Care (DISC) 2.0 Study
Version 1.1
REFNo: HS5767ES
1. To describe health facility readiness to provide voluntary DMPA-SC SI within the existing contraceptive method mix in DISC-supported facilities in Uganda.
2. To describe quality of contraceptive counseling and client experiences among clients receiving injectables at DISC-supported facilities in Uganda.
3. To understand clients’ self-efficacy and confidence around DMPA self-injection immediately post-training and at 4-months follow-up in Uganda.
4. To improve understanding of DMPA-SC ‘take home’ units, including dispensation practices, provider and client preferences, storage, and usage, and disposal at initiation and 4-months follow-up.
|
Uganda |
2025-04-02 10:31:32 |
2028-04-02 |
Medical and Health Sciences |
Non-Clinical Trial |
Non-degree Award |
|
Susan Nabadda
ID: UNCST-2020-R014331
|
Field Performance Evaluation of the Genbody ConfiSign HIV Self-Test in Uganda
REFNo: HS5760ES
To evaluate the field diagnostic performance and operational characteristics; usability, acceptability, and feasibility of the Genbody ConfiSign HIV ST in Uganda.
Specific objectives
a) To determine the field diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of the Genbody ConfiSign HIV Self Test compared with the Wondflo HIV Self test (Guangzhou, China).
b)To evaluate the operational characteristics; feasibility, acceptability, and usability of the Genbody ConfiSign HIV ST in selected health facilities.
|
Uganda |
2025-04-02 10:25:15 |
2028-04-02 |
Medical and Health Sciences |
Non-Clinical Trial |
Non-degree Award |
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