Active clinical trials for "Tuberculosis"

Title: Artificial Neural Network as Diagnostic Tools For Rifampicin-Resistant Tuberculosis In Indonesia. A Predictive Model Study and Economic Evaluation. Background: Drug-resistant tuberculosis has become a global threat particularly in Indonesia. The need to increase detection, followed by appropriate treatment is a concern in dealing with these cases. The rapid molecular test (specifically for detecting rifampicin-resistant) is now being utilized in health care service, particularly at primary care level with some challenges including the lack of quality control (including how to obtained and treat the specimen properly prior to the examination) which then, affect the reliability of the results. Drug-Susceptibility Test (DST) is still, the gold standard in diagnosing drug-resistant tuberculosis but this procedure is time-consuming and costly. The artificial intelligent including data exploration and modeling is a promising method to classify potential drug-resistant cases based on the association of several factors. Objective : To develop a model using an artificial intelligence approach that is able to classify the possibility of rifampicin-resistant tuberculosis. To assess the diagnostic ability and the accuracy of the model in comparison to existing rapid test and the gold standard To evaluate the cost-effectiveness evaluation of Artificial Neural Network model in Web-Based Application in comparison with the standard diagnostic tools Methodology A cross-sectional study involving all suspected drug-resistant tuberculosis cases that being referred to the study center to undergo rapid molecular test and DST test over the past 5 years. A comprehensive, retrospective medical records assessment and tuberculosis individual report will be performed to obtain a variable of interest. Questionnaire assessment for confirmation of insufficient information. Model Building through machine learning and deep learning procedure Model Validation and testing using training data set and data from the different study center Hypothesis : Artificial Intelligent Model will yield a similar or superior result of diagnostic ability compare the Rapid Molecular Test according to the Drug-Susceptibility Test. (Superiority Trial)

Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)

The purpose of this study is to evaluate the experimental tuberculosis (TB) vaccine called ID93+GLA-SE. The safety, immunogenicity, and efficacy of ID93+GLA-SE will be compared to placebo, after three intramuscular (IM) injections one month apart in healthy healthcare workers. The healthcare workers will all have had the childhood TB vaccine called BCG, and all of them must have a negative result for a blood test for exposure to the bacteria that cause TB (QuantiFERON-TB Gold Plus, or "QFT"). Study participants will be followed for 12 months after the last injection for safety reasons. Blood will be drawn for laboratory tests for safety, immunogenicity, and efficacy tests. Efficacy will be evaluated by further QFT testing. The study hypothesis is that the vaccine is safe, immunogenic, and effective in this study population.

Routine childhood immunization (RCI) in Pakistan is well below the recommended coverage of 90% with rates as low as 16% in certain regions (Pakistan DHS 2012-3). This has led to continued polio transmission, large measles outbreaks and thousands of deaths from vaccine-preventable diseases (Kazi.Bull WHO 2016). Mobile phone communication is widespread in developing countries and has proven a potential method of directly connecting pregnant women and mothers to health services (Kharbanda. Expert Review of Vaccine 2014). The investigators propose conducting a mixed methods proof of concept cluster randomized trial (CRT) to assess the effectiveness of different types of SMS messaging and automated calls to improve RCI and understand the perceptions and barriers that may affect SMS and automated call-based interventions at participants levels. the investigators will conduct the study at urban and rural sites in Pakistan. The investigators will examine an important public health question - do low cost, automated SMS, and automated messages improve RCI coverage in resource-constrained settings? Further, investigators will compare the effectiveness of reminder, educational and interactive text messages for improving RCI and will generate socio-cultural data regarding the impact of participants health beliefs that will be important for setting up the appropriate interventions in other LMICs.

This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.

Introduction: Finding and successfully treating all tuberculosis (TB) patients is the cornerstone of the Global Strategy to Stop TB. However, many patients in resource-limited countries remain undiagnosed. Prisons are a well-known source of undetected TB. Thus, there is a need to find feasible interventions to find and treat TB patients in these settings. Objective: The objective of this study is to evaluate whether empowering and involving inmate peer educators in TB control has an impact on increasing TB case detection rate and improving treatment success in resource-limited prison settings. Methodology: This is a matched cluster randomized control trial where randomization to the intervention and treatment groups will be carried out within pairs. Eight matched prison pairs will be randomly selected for this study in which eight prisons from each pair will be randomly assigned to the intervention and the remaining to the control group. Trained prison peer educators at the intervention sites will organize and provide education about TB every two weeks on a regular basis for one year. Peer educators will also perform routine TB screening, using a screening protocol to identify presumptive TB cases for a referral. Identified presumptive TB cases will then be linked to the prison health personnel for a referral to nearby hospitals. The TB diagnosis will be carried out at the referral sites using the routine direct smear microscopy and/or chest X-ray (Radiography). Tuberculosis case finding in the control sites will follow the existing referral system (self-referral to nearby hospitals) and the diagnosis will be undertaken using direct sputum microscopy and/or chest X-ray as in the intervention sites. The data will be entered using Epi Data entry version 3.1 software and analyzed using SPSS version 20.0. Considering prisons as a unit of analysis, the mean Case Detection Rate (CDR), Treatment Success Rate (TSR) and the percentage of patients symptomatic for > =3 months will be compared within pairs using the paired t-test or sign test as appropriate.

The purpose of this pilot study is to evaluate the sensitivity and specificity of a nanotube-based point-of-care breath-based tuberculosis screening test as compared to the current standards of care including sputum microscopy, sputum culture, chest X-ray, and GeneXpert (MTB/RIF). The primary objective is to determine an initial estimate of the sensitivity and specificity of a nano-tube based point-of-care test for the diagnosis and screening of active pulmonary tuberculosis. Secondary objectives include the collection of user data to test and further develop the screening platform based on end-user feedback.

The purpose of this study is to determine the diagnostic utility of the device 'Electronic Nose' for Pleural TB, which is a Extra pulmonary TB form, compared with pleural biopsy, the current gold standard.

The purpose of this study is to compare the diagnostic efficacy of nested and realtime polymerase chain reaction for Mycobacterium tuberculosis using EBUS-TBNA samples in patients with isolated intrathoracic lymphadenopathy.

Study Design: Stratified, matched, cluster-randomized, controlled trial Unit of Randomization: Healthcare facility Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among susceptible HCWs at 12 and 24 months. Secondary outcomes will be measures at 0 (pre-intervention) 6, 12, 18, and 24 months. In year three, results will be analyzed and disseminated. Study Components: Assessment of institutional safety culture; observations/audits of Tuberculosis (TB) patient flow (wait times) and HCW TB infection control (IC) practices; documentation of time intervals for processing sputum smears and initiation of TB treatment; facility assessments; random allocation and implementation of enhanced Tuberculosis infection control (TB IC) package; testing of HCWs to determine LTBI at 0, 12, 24 months; cost evaluation of intervention. Sample Size: For the cluster randomized design, we estimate that 11 clusters per group will allow for 77 percent (%) power to identify a 30% reduction in LTBI incidence in the intervention vs. control clusters. This assumes LTBI incidence 5% per year in the control group, design effect for clustering of 2.0, and cluster size of 300 (average 600 HCW per cluster with 50% LTBI prevalence at baseline).