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Ndwandwe DE, Runeyi S, Pienaar E, Mathebula L, Hohlfeld A, et al.
Background The Pan African Clinical Trials Registry (PACTR) is a WHO International Clinical Trials Registry Platform primary register, which caters for clinical trials conducted in Africa. PACTR is the first and, at present, the only member of the Network of WHO Primary Registers…
James J, Jamuna Rani R, Sathyanarayanan V, Sudha K
…is study, all Tuberculosis-related studies registered under Clinical Trial Registry of India from its inception in July 2007 to February 2021 were reviewed and analysed using the keyword ''Tuberculosis'' in the 'Trial Search' section. A total of 31,196 studies were registered in …
Park JJH, Grais RF, Taljaard M, Nakimuli-Mpungu E, Jehan F, et al.
…n this Series paper, we provide a historical perspective on clinical trial research by revisiting the 1948 streptomycin trial for pulmonary tuberculosis, which was the first documented randomised clinical trial in the English language, and we discuss its close connection with glo…
Manjula Singh, Sindhu Joshi, Vikram Vohra, Rohit Sarin, Suchit Vasant Kamble, et al.
…ection, and immunogenicity. **DESIGN:** Phase 3 randomised clinical trial (PreVenTB trial). **SETTING:** 18 sites across six states of India. **PARTICIPANTS:** 12 717 healthy household contacts (aged ≥6 years) of patients with a smear positive TB test. **INTERVE…
Grace AG, Mittal A, Jain S, Tripathy JP, Satyanarayana S, et al.
…up Specialized Register; the Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE (PubMed); Embase; the Latin American Caribbean Health Sciences Literature (LILACS); Science Citation Index-Expanded; Indian Medlars Center; and the South Asian Database …
Ndwandwe D, Dube K, Mathebula L, Wiysonge CS
Clinical research is important in establishing the effects of health-care interventions. Vaccine clinical trials are to examine the effectiveness and safety of vaccines for the prevention of diseases. Africa has a high burden of infectious diseases such as malaria, tuberculosis, …
Padmapriyadarsini C, Oswal VS, Jain CD, Mariappan MV, Singla N, et al.
… were enrolled in a multicenter, parallel-group, randomized clinical trial in India. Patients were randomized to 26 weeks of bedaquiline, pretomanid, and daily linezolid, at 600 mg for 26 weeks (arm 1); 600 mg for 9 weeks followed by 300 mg for 17 weeks (arm 2); or 600 mg for 13 …
Starke SJ, Martinez Rivera MB, Krishnan S, Shah M
…sis and management of latent tuberculosis infection (LTBI). Clinical practice guidelines and recommendations exist for LTBI management, but there is a need for innovative tools to improve medical students' and residents' knowledge of evidence-based practices for LTBI testing and …
Chandra H, Rahman A, Yadav P, Maurya G, Kumar Shukla S
…randomized, double blind, parallel group, active controlled clinical trial. Newly diagnosed Vitamin D deficient pulmonary tuberculosis patients were randomly assigned to intervention group (received standard anti-tubercular treatment with adjunct Vitamin D3) and control group (re…
Strüver V, Ibeneme SC
Background The business of clinical research has changed in the past two decades, shifting from industrialised Western countries to so-called emerging markets such as Eastern Europe, Latin America and Africa. An appraisal of the trends could identify associated factors that may h…
Sara Domínguez-Rodríguez, David Lora, Alfredo Tagarro, Cinta Moraleda, Álvaro Ballesteros, et al.
**BACKGROUND:** The EMPIRICAL trial aims to assess safety and efficacy of an empirical treatment against cytomegalovirus (CMV) and tuberculosis (TB) compared to standard of care (SoC), on adverse events and 15-day and 1-year mortality among infants living with HIV hospitalized wi…
da Silva RE, Amato AA, Guilhem DB, de Carvalho MR, Novaes MRCG
…ual health needs. Objective: To map the global landscape of clinical trials run in Latin American and Caribbean countries and discuss the addressing of local health needs in the agenda of international clinical trials. Methods: The present study is a cross-sectional overview and …
M Munera-Campos, A González Quesada, M Espasandín Arias, M A Lasheras-Pérez, P de la Cueva Dobao, et al.
**BACKGROUND:** Randomized clinical trials (RCTs) supporting advanced treatments for atopic dermatitis (AD) involve highly selected patients, limiting their generalizability. **OBJECTIVE:** To determine the proportion of adults on advanced systemic therapy for AD in clinical pra…
Rojo P, Moraleda C, Tagarro A, Domínguez-Rodríguez S, Castillo LM, et al.
… is a Phase II-III, open-label randomized factorial (2 × 2) clinical trial, conducted in six African countries. The trial has four arms. Infants from 28 to 365 days of age HIV-infected and hospitalized with severe pneumonia will be randomized (1:1:1:1) to (i) SoC, (ii) valgancicl…
Sanjeev Sinha, Himanshu Thukral, Imtiyaz Shareef, Devashish Desai, Binit Kumar Singh, et al.
…e. Methods: This randomized double-blind placebo-controlled trial was conducted in three sites in India. HIV negative participants aged 15-60 years with sputum smear positive PTB were recruited according to the Revised National Tuberculosis Control Program guidelines and were ran…
Kong Z, Liang N, Yang GL, Zhang Z, Liu Y, et al.
…ds We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, and seven other databases to 1 March 2019. We also searched the World Health Organization International Clinical Trials Registry Platform (www.who.int/ictrp), Clinical…
Misra UK, Kalita J, Kumar M
…articipants This is a single-center, open-label, randomized clinical trial conducted from October 2015 to April 2017 in India. Patients were randomized in a 1:1 ratio to arms receiving saline only or saline plus fludrocortisone, in addition to a standard treatment of 4 antituberc…
Wang Y, Yang JW, Yan SY, Lu Y, Han JG, et al.
… participants This multicenter, randomized, sham-controlled trial was conducted in China from October 12, 2020, through October 17, 2021. There was a 1:1 allocation using the dynamic block random method, and analyses were by intention to treat. Patients 18 years or older undergoi…
Kong Z, Liang N, Yang GL, Zhang Z, Liu Y, et al.
…ic searches of the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index Expanded, Conference Proceedings Citation Index - Science, China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), Wanfang Data, an…
Chabala C, Turkova A, Thomason MJ, Wobudeya E, Hissar S, et al.
…ent in children is largely extrapolated from adult studies. Trials in adults with smear-negative tuberculosis suggest that treatment can be effectively shortened from 6 to 4 months. New paediatric, fixed-dose combination anti-tuberculosis treatments have recently been introduced …
Wen Y, Li L, Deng Z
… and low 25(OH)D levels. Methods This randomized controlled clinical trial enrolled treatment-naïve patients with tuberculosis admitted to Zigong First People's Hospital (June 2016 to April 2017). The patients were grouped as the serum 25(OH)D ≥ 75 nmol/L (Normal-25(OH)D) and 25(…
Cola JP, do Prado TN, Alves BMCS, Sales CMM, Borges BJP, et al.
…ts. Methods Pragmatic, randomized, non-blinded, multicenter clinical trial conducted in Brazil from January 2019 to December 2022. Subjects over the age of 18 years with an indication for TPT was included and those whose index case of active tuberculosis was in retreatment, multi…
Sinha S, Thukral H, Shareef I, Desai D, Singh BK, et al.
…se. Methods This randomized double-blind placebo-controlled trial was conducted in three sites in India. HIV negative participants aged 15-60 years with sputum smear positive PTB were recruited according to the Revised National Tuberculosis Control Program guidelines and were ran…
Mritunjai Kumar, Anu Singh, Rajni Singh, Nikita Dhar, Jagbir Singh, et al.
…s with tuberculous meningitis (TBM) remains uncertain. This trial compared the effectiveness and safety of ethambutol (ETM) versus streptomycin (STM) during the intensive phase. **METHODS:** This is an investigator-initiated, single-center, open-label, randomized controlled tria…
Mwansa-Kambafwile JRM, Chasela C, Levin J, Ismail N, Menezes C
…ving TB treatment initiation. A 3-arm randomized controlled trial (Standard of care-SOC, SMS technology or WBOTs) was conducted between September 2018 and April 2020. Newly diagnosed TB patients randomly allocated to SMS and WBOTs groups were sent reminder messages (text message …