There are about 128 clinical studies being (or have been) conducted in Rwanda. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This feasibility study serves to determine if it is possible to perform a powered randomized control trial of high-dose intravenous vitamin C (ascorbic acid) as an adjunctive medication in the management of sepsis and septic shock in Rwanda. Further data will be collected including Sequential Organ Failure Assessment (SOFA) score, Universal Vital Assessment (UVA) score, duration of vasopressors, mortality and other key indicators to possibly determine the impact of vitamin C on organ failure and clinical course. A total of 24 patients with a diagnosis of sepsis or septic shock will be recruited after obtaining informed consent at the University Teaching Hospital of Kigali (CHUK) and will be randomized in a 1:1 fashion to receive drug or placebo. Both treatment arms will receive standard treatment (intravenous fluids, antibiotics, vasopressors as needed, etc.) in addition to study drug or placebo. During the course of the study, any difficulties encountered will be recorded and will inform process improvements for a full randomized control, if it is indeed considered possible to perform the definitive trial.
Palliative care is an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness such as cancer, through the prevention and relief of suffering by means of early identification and treatment of pain and other physical and psychosocial problems. Despite the rising incidence of cancer, the availability of comprehensive palliative care services across Sub Saharan Africa is extremely limited. The current study will test the efficacy of the newly developed smart phone based symptom evaluation app (application), in improving the management of the palliative care needs of patients with advanced cancer in Rwanda. RPCHO is the Rwanda Palliative Care and Hospice Organization that provides palliative care services to advanced cancer patients in Rwanda. About 80 patients enrolled under the RPCHO will be enrolled in the current study. Those who agree to take part in the study will be randomly assigned to either a standard care group or intervention group. Patients in both the arms will continue to receive the standard palliative care currently provided at the RPCHO. Additionally, patients in the intervention group will receive new smart-phone application based alerts, bi-weekly, on their mobile phone to fill out the short symptom assessment form. In addition, patients will also be able to complete a symptom assessment at any time they feel that their symptoms are poorly controlled or getting worse. The team at RPCHO will have desktop based dashboard where they will be able to track all patient's information. This will assist them in early identification and response to any worsening symptoms. Patients enrolled in both standard arm and intervention arm, will be asked to make three visits at the RPCHO at baseline, at 6 weeks, at 3 months. During this visits the RPCHO research staff will conduct their physical and psychological assessment. We hope to find significant improvement in pain score, other symptoms and quality of life, as measured by standard validated scores, for patients enrolled under the intervention arm (using the smart phone app) as compared to standard care arm at 6 weeks and at 3 months. Thus we hope to demonstrate that the new smartphone-based app can be successfully used for both the assessment and management of pain and other symptoms and providing palliative care services for advanced cancer patients in low and middle income countries.
This is a double-blind, randomized, placebo-controlled Phase III study to assess the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.