Isaac Ssewanyana
ID: UNCST-2020-R014336
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ASSESSMENT OF USABILITY OF THE WONDFO HIV SELF-TEST ONE STEP HIV 1/2 WHOLE BLOOD/SERUM/PLASMA TEST BY UNTRAINED USERS
REFNo: HS1878ES
To evaluate the ability to correctly comprehend key messaging from device packaging and labelling, including the Instructions for Use.,The evaluation of untrained users’ and their interaction with the device in terms of effectiveness and efficiency, i.e. successful / unsuccessful completion and difficulty of the critical steps as per the Instructions for Use,To evaluate the ability of untrained users to obtain an accurate HIV test result using the Wondfo HIV Self-Test.,
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Buhweju, Nsika
Wakiso, Central
Bulambuli, Bulambuli Town Council
Mbale, Mbale City
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Uganda |
2022-08-30 10:24:48 |
2025-08-30 |
100 |
All participants will be > 18 years old of all Sex from the bamasaba region |
Central Public Health Laboratories |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Prudence Atukunda Friberg
ID: UNCST-2023-R006221
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The NutriMind Trial: A low-cost randomized trial combining a healthy diet and psychotherapy to treat depressive symptoms among university students – The case of Uganda
REFNo: HS2146ES
The primary outcome is a mean reduction of 6 scores on the CES-D scale
• Biomarkers of metabolism (i.e. lipids, carbohydrates and hormones) will be measured in samples from blood, urine or saliva as appropriate and using standard methods.
• Biomarkers of inflammation (e.g. CRP, interleukins) and antioxidants will be measured in blood, urine or saliva as appropriate and using e.g. multiplex-techniques, immunolabelling methods and metabolomics.
• Microbiome will be analysed in samples from the oral cavity and from feces using established techniques (16S rRNA amplicon sequencing and reduced metagenome sequencing).
The combined intervention arm with MBCT and Diet will reduce depressive symptoms more than the control arm
Biomarkers of metabolism ( lipids, carbohydrates and hormones) measured in samples from blood, urine or saliva as appropriate and using standard methods
Biomarkers of inflammation ( CRP, interleukins) and antioxidants measured in blood, urine or saliva as appropriate and using multiples-techniques, immunolabelling methods and metabolomics
Microbiome will be analysed in samples from the oral cavity and from feces using established techniques ( 16rRNA amplicon sequencing and reduced metagenome sequencing)
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Kampala, Makerere
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Uganda |
2022-08-03 11:19:53 |
2025-08-03 |
200 |
The study population is university students with self reported depression symptoms as determined by Beck depression Inventory validated assessment tool. The partcipants will be aged range 19 and above both female and males will be included from all the tr |
University of Oslo |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Atupele Mlangwa Subira
ID:
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PREVALENCE AND FACTORS ASSOCIATED WITH PROLONGED HOSPITAL STAY FOLLOWING CAESEREAN DELIVERY AT MBARARA REGIONAL REFERRAL HOSPITAL
REFNo: NS383ES
2. To determine the factors associated with prolonged hospital stay following caesarean delivery at MRRH,1. To determine the prevalence of prolonged hospital, stay following caesarean delivery at MRRH,To determine the prevalence and factors associated with prolonged hospital stay following caesarean delivery at MRRH,
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Mbarara, Medical Cell
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Tanzania |
2022-07-26 11:29:37 |
2025-07-26 |
427 |
Adult women delivered by caesarian section at Mbarara Regional Referral Hospital |
Atupele Subira Mlangwa |
Natural Sciences |
Clinical Trial |
Degree Award |
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Nixon Niyonzima
ID: UNCST-2020-R014577
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A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY
REFNo: HS2173ES
8. To validate the ability of fertility biomarkers to diagnose and predict permanent loss of ovarian function, and to determine the impact of anti-cancer therapy on hormone levels,7. To evaluate health status utility scores of patients treated with atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine,6. To identify and/or evaluate biomarkers that are predictive of response to atezolizumab and trastuzumab emtansine (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to atezolizumab and trastuzumab emtansine, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of atezolizumab and trastuzumab emtansine activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety,5. To evaluate the immune response to atezolizumab and trastuzumab emtansine,4. To characterize the PK profiles of atezolizumab and trastuzumab emtansine when given in combination,3. To evaluate the safety of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine,2. To evaluate the efficacy of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine in the PRO-evaluable analysis set,1. The secondary efficacy objective for this study is to evaluate the efficacy of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine in both the ITT population and PD-L1-positive population,The primary objective for this study is to evaluate the efficacy of atezolizumab when given in combination with trastuzumab emtansine compared with placebo and trastuzumab emtansine in both the ITT population (all comers) and the PD-L1-positive population (defined as all patients from the ITT population with a centrally assessed PD-L1-positive status [i.e., PD-L1 status of IC1/2/3] at randomization),
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Kampala, Mulago
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Uganda |
2022-07-21 11:00:02 |
2025-07-21 |
30 |
This study will enrolling women with a primary diagnosis of HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease i |
Nixon Niyonzima |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Moffat Nyirenda Joha
ID: UNCST-2020-R019333
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Development and Evaluation of an Integrated Community-based Management Model for HIV, Diabetes, and Hypertension in Tanzania and Uganda (The INTE-COMM study)
REFNo: HS2278ES
To determine the effectiveness of community-based integrated management of HIV, diabetes, and hypertension in comparison to clinic-based integrated management of these conditions in terms of patient outcomes, acceptability, and potential cost-effectiveness.
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Kampala, N/A
Wakiso, N/A
Mpigi, N/A
Lwengo, N/A
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Malawi |
2022-07-13 16:33:33 |
2025-07-13 |
1,736 participants |
Assuming an intra-class coefficient, rho of 0.02, we need to form 116 groups, each comprising 12 persons (8 with diabetes or hypertension and 4 with HIV). This will provide over 80% power to detect an absolute difference in risk of diabetes and hypertension control of 10% (i.e. 50% versus 60% achieving good control in the 2 arms would be statistically significant at the 5% two-sided significance level). Power will be very high for differences larger than this. For the HIV viral suppression endpoint, we assume that viral suppression is close to 90% and that the primary aim is to show non-inferiority with the community-care arm (and secondary analyses will compare superiority). The trial will have over 80% power to show non-inferiority with a margin of delta= 8.5%, 7.5%, and 5.5% assuming viral suppression is 85%, 90% and 95% respectively. To allow for losses to follow-up, our target for enrolment is 124 groups each comprising 14 participants (i.e. a total of 1,736 participants). |
National Institute of Health Research (NIHR) |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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