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NCT ID: NCT03512678 Completed - Malaria Clinical Trials

Evaluation of a Digital Microscope for Malaria

EasyScanGo
Start date: June 25, 2018
Phase:
Study type: Observational

Light microscopy, which is based on century-old technology, remains a key indicator in drug efficacy testing performed in the context of clinical trials for monitoring existing antimalarial drugs or in the context of regulatory clinical trials for registration of new drugs. It is one of the main diagnostic methods for malaria diagnosis in general, as in an ideal setting it can provide low-cost accurate diagnosis, determine the density of parasites in the blood, and accurately differentiate between different malaria parasite species, characteristics vital to the implementation of global plans for drug efficacy monitoring. Malaria rapid tests (RDTs), while useful for rapid diagnosis and case management, do not provide information on the parasite density nor the species differentiation necessary for research and drug efficacy assessment. Microscopy therefore retains key advantages over a number of newer technologies, but its reliability is severely impeded by dependence on high technical competence of the human operators as well as availability of high quality equipment and reagents. Recent studies have demonstrated frequent poor specificity and sensitivity associated with manual microscopy diagnostics in operational conditions. These drawbacks constitute a major limiting factor to effective monitoring and preservation of vital anti-malarial medicines. Advances in digital microscopy performance and affordability have now opened the door to potentially significant improvements in the performance of malaria microscopy, overcoming serious deficiencies in current drug efficacy assessment, and more broadly in malaria diagnosis and management. Global Good (GG)/Intellectual Ventures Laboratory (IVL) sponsored by the Global Good Fund, has developed a microscope prototype consisting of low cost components to scan and capture images from Giemsa-stained thick blood films on slides. The captured images are analyzed with custom image analysis software developed at GG/IVL, using algorithms that are designed for automatic malaria diagnosis, without user input. Versions of a prototype of the device were first tested in field settings in Thailand in 2014-2015 at clinics operated by the Shoklo Malaria Research Unit (SMRU) and then again in 2016-2017. When compared to expert microscopy at SMRU, the performance of the device with respect to diagnostic sensitivity (87.8%), species identification (85.6% species correctly identified) and parasite density estimation (44% of estimates within +/-25% of reference microscopy result) corresponded to WHO Competence Level 2. The device and the accompanying image analysis algorithms have since been further developed and a new, third version of the prototype is now available for testing in diverse settings with varying malaria prevalence and user expertise.

NCT ID: NCT03512210 Completed - Hepatitis C Clinical Trials

Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection

MINMON
Start date: October 22, 2018
Phase: Phase 4
Study type: Interventional

To achieve global hepatitis C virus (HCV) elimination by 2030, 80% of the ~71 million people with chronic HCV infection will need to be treated, necessitating simplification of treatment delivery and associated laboratory monitoring without compromising efficacy or safety. The COVID-19 pandemic has further highlighted the need for innovative models of health care delivery that minimize face-to-face patient-provider contact. The purpose of this study was to evaluate the feasibility, safety, and efficacy of a minimal monitoring (MINMON) strategy to deliver interferon- and RBV-free, pan-genotypic DAA therapy to treat active HCV in HCV treatment naïve participants.

NCT ID: NCT03512093 Completed - Preterm Birth Clinical Trials

Improving SCBU Care for Preterm Babies

PretermBabies
Start date: May 1, 2018
Phase:
Study type: Observational

Since 2008, preterm neonates are taking care of in a Special Baby Care Unit (SCBU). Those born less than 34 weeks of gestation are followed-up monthly for one year for monitoring their hematocrit level, growth and development. Medical chart reviews are useful to evaluate the burden of diseases, characterize care treatment patterns and clinical outcomes by patients' subgroups; ultimately it can help identifying gaps in care pathways thus improving quality of care and ultimately reducing mortality. Medical records of all preterm neonates hospitalized in the SCBU including those followed up during their first year of life are computerized. The investigators propose to review the clinical charts of the preterm neonates in regards to four main points of care a) feeding, b) infections including early onset of neonatal sepsis, necrotizing enterocolitis and umbilical cord infection, c) body temperature control and d) respiratory distress. This medical charts review will be complemented by i) focus group discussions (FGD) with the medical staff working in the SCBU on the benefits and difficulties in using the existing guidelines for preterm care and by ii) interviews with mothers who delivered a preterm neonate on their experience in caring for their child and the challenges they faced. While performing the retrospective part of the project and after discussing the preliminary findings from the medical staff perception of the existing guidelines, the investigators will evaluate the feasibility to implement some additional recommendations to improve preterm birth outcomes based on recent literature and new protocols for resource-limited settings.

NCT ID: NCT03510013 Completed - Anesthesia Clinical Trials

1-1-8 Wash-in for Sevoflurane Low Flow Anesthesia

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

The investigators propose a new wash-in technique for sevoflurane low flow anesthesia with fresh gas flow of O2:N2O or O2:air 1:1 L/min with sevoflurane 8%. The objective of this study is to identify time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5%

NCT ID: NCT03501212 Recruiting - Radial Artery Spasm Clinical Trials

Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization

Start date: April 27, 2019
Phase: Phase 4
Study type: Interventional

This study evaluate topical anaesthesia application for 30 minutes before tranradial catheterization during cardiac catheterization can reduce pain and decrease radial artery spasm

NCT ID: NCT03499899 Completed - Clinical trials for Triple-negative Breast Cancer

A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer

Start date: July 2, 2018
Phase: Phase 2
Study type: Interventional

The main purpose of this study was to assess the antitumor activity of three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in participants with advanced triple-negative breast cancer (TNBC) in first or second line therapy.

NCT ID: NCT03498716 Completed - Clinical trials for Triple Negative Breast Cancer

A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer

IMpassion030
Start date: August 2, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

NCT ID: NCT03498521 Active, not recruiting - Clinical trials for Cancer of Unknown Primary Site

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

CUPISCO
Start date: July 10, 2018
Phase: Phase 2
Study type: Interventional

This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.

NCT ID: NCT03498300 Completed - Pregnancy Related Clinical Trials

Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women

Start date: May 9, 2018
Phase: Early Phase 1
Study type: Interventional

This study evaluated the seroprevalence of Bordetella pertussis antibodies and anti-pertussis antibody response after a single dose of reduced-antigen, combined diphtheria, tetanus, and acellular pertussis vaccine (Tdap) in pregnant Thai women. All seronegative participants received Tdap, while seropositive participants were equally randomized into 2 groups. Half of seropositive participants received Tdap and the other half received tetanus-diphtheria (Td) as standard protocol.

NCT ID: NCT03497676 Active, not recruiting - HIV Infections Clinical Trials

More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

MOCHA
Start date: March 19, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) LA and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral CAB,CAB LA, and RPV LA in virologically suppressed HIV-infected children and adolescents.