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NCT ID: NCT04122404 Completed - Clinical trials for Acquired Immunodeficiency Syndrome

POC Strategies to Improve TB Care in Advanced HIV Disease

TBPOC
Start date: October 14, 2019
Phase: N/A
Study type: Interventional

Tuberculosis (TB) remains the major cause of morbidity and mortality among patients with HIV. Sub-optimal diagnostics contributes towards poor patient outcome and there is an urgent need to identify non-sputum-based point-of-care diagnostic tests. The urine based lateral flow lipoarabinomannan TB diagnostic test (LF-LAM) is a simple, inexpensive point-of-care test. In 2015, the World Health Organization endorsed LF-LAM for conditional use among patients with advanced HIV, but uptake of the test in clinical practices has been poor. The investigators aim to identify point-of-care (POC) strategies that can improve TB case detection and clinical outcomes among patients with advanced HIV. The project includes a main study and two sub-studies. The main study is a multicenter stepped wedge cluster-randomized controlled trial of LF-LAM implementation among patients with advanced HIV with 8-weeks follow-up. LF-LAM will be added to standard care and implemented stepwise at three hospitals in Ghana. Education in national TB treatment guidelines in collaboration with the Tuberculosis Control programme in Ghana, and Clinical audit of clinical staff with feedback, will be used to assess and strengthen LF-LAM implementation. The primary outcome time to TB treatment, for which a sample size of 690 participants will provide >90% power to detect a minimum of 7 days reduction. Secondary outcomes are: TB related morbidity, TB case detection, time to TB diagnosis and overall early mortality at 8 weeks. The HIV-associated TB epidemiology including genotypic analyses of M. tuberculosis isolates obtained through the main study will be described. In sub study A, focused ultrasound of lungs, heart and abdomen will be performed in a sub cohort of 100 participants. In sub study B, the investigators will establish a biobank and data warehouse for storage of blood, urine and sputum samples collected from participants that enter the study at Korle-Bu Teaching hospital. It is expected that LF-LAM will lead to earlier diagnosis and treatment of TB. Findings may further guide scaling-up of LF-LAM. The HIV-associated epidemic including genotypic properties and resistance properties which is important for improved management will be detailed. The investigators further expect to evaluate the potential of bedside ultrasound as a clinical tool in management of HIV/TB co-infected patients. The unique Ghanaian HIV-cohort and biobank may facilitate rapid evaluation of future prognostic biomarkers and new point-of-care TB diagnostic tests.

NCT ID: NCT04122352 Completed - Clinical trials for Temporomandibular Joint Dysfunction

The Effects of Trigger Point Treatment in Temporomandibular Joint Dysfunction

Start date: July 7, 2019
Phase: N/A
Study type: Interventional

The aim of this study to investigate the effectiveness of trigger point treatments (ischemic compression) on pain intensity, chronic pain severity, range of motion(ROM), pain pressure threshold (PPT) and functionality on patient with temporomandibular joint dysfunction.(TMD)

NCT ID: NCT04122300 Completed - Preterm Neonates Clinical Trials

Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct

Euphrasia
Start date: May 22, 2011
Phase: Phase 3
Study type: Interventional

Congenital nasolacrimal duct obstruction (CNLDO) occurs in approximately 10 to 20% of all term newborns, and is the most common cause of persistent tearing and ocular discharge in children. CNLDO causes symptoms in up to 6% of children during the first year of life. The first clinical signs appear during the first month of life in 95% of cases and usually consist of tearing and debris on the eyelashes ("mattering"). Mucopurulent eye discharge occurs commonly in infants with CNLDO and, in the absence of other signs of infection, suggests bacterial overgrowth in the stagnant tear pool of the lacrimal sac. This study investigates whether early administration of Euphrasia eye drops (Weleda AG, Arlesheim) in preterm neonates presenting with first ocular discharge with or without tearing and reddened eye fosters the resolution of the ocular discharge and reduces the need for topical antibiotic therapy.

NCT ID: NCT04121936 Completed - Clinical trials for To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland

The Prevalence of Lower Urinary Tract Symptoms (LUTS) in Poland

Start date: November 11, 2019
Phase:
Study type: Observational

The first large population-based study to evaluate lower urinary tract symptoms (LUTS) in Poland. The study objective is to assess the prevalence and bother of LUTS in the population aged ≥40 years in Poland.

NCT ID: NCT04121767 Completed - Atrial Fibrillation Clinical Trials

Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to compare the safety and efficacy of edoxaban and warfarin for prevention of stroke during a 6-month follow up after total thoracoscopic ablation.

NCT ID: NCT04121507 Completed - Lymphoma, B-Cell Clinical Trials

ASTRAL- a Clinical Study to Assess the Efficacy and Toxicity of High-dose Chemotherapy

Start date: June 24, 2019
Phase: Phase 2
Study type: Interventional

A prospective Phase II clinical study to assess the efficacy and toxicity of high dose chemotherapy (HDT) followed by allogeneic stem cell transplantation (allo- or autoSCT) as treatment of primary progressive and relapsed aggressive Non-Hodgkin Lymphoma (NHL) - ASTRAL

NCT ID: NCT04121494 Completed - Tuberculosis Clinical Trials

ChAdOx1 85A Aerosol Versus Intramuscular Vaccination in Healthy Adults (TB039)

TB039
Start date: January 22, 2019
Phase: Early Phase 1
Study type: Interventional

This is a dose escalating and a paired-placebo design study to describe the safety and immunogenicity profile of candidate TB vaccine ChAdOx1 85A given by aerosol inhaled vaccination versus intramuscular (IM) vaccination in adult healthy volunteers. It is postulated that the aerosol inhaled route is practical and feasible and has an acceptable safety profile, comparable to the systemic safety profile of the IM route of administration of ChAdOx1 85A in adult healthy volunteers, and that the aerosol inhaled route of administration will induce greater mucosal immunity and comparable systemic immunity when compared to the IM (systemic) route of administration in these volunteers. Volunteers are followed on a regular basis for safety and immunogenicity, with blood analysis for biological safety tests and immune tests.

NCT ID: NCT04121221 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS

Start date: September 19, 2019
Phase: Phase 3
Study type: Interventional

A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks

NCT ID: NCT04120337 Completed - Clinical trials for Removal of a Contraceptive Subdermal Implant

Safe Access: Trial With RemovAid Device

Start date: December 23, 2019
Phase: N/A
Study type: Interventional

This randomized trial will compare different approaches to removing a subdermal contraceptive implant from the upper arm of 225 women in Uganda. The experimental approach is a hand-held device (RemovAid) that incises the skin and grasps the implant for extraction. Safety and efficacy endpoints will be compared to the traditional removal approach (scalpel, forceps, tweezers).

NCT ID: NCT04120324 Completed - Osteoarthritis, Hip Clinical Trials

Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty

Start date: October 15, 2018
Phase:
Study type: Observational

Amongst patients who are discharged home from hospital on the same day as their elective Primary Total Hip Arthroplasty, the Investigators seek to quantify the incidence of return to hospital within 30 days of surgery for assessment &/or treatment of surgical related problems or complications. This incidence rate will be compared to a cohort of patients who are not discharged on the same day as their Primary Total Hip Arthroplasty. The Investigators wish to know if the incidence of 30 day return to hospital is significantly different between these two groups of patients.