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NCT ID: NCT05383742 Recruiting - Clinical trials for Tuberculous Meningitis

Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis

Start date: December 7, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare a 6-month regimen of high-dose rifampicin (RIF), high-dose isoniazid (INH), linezolid (LZD), and pyrazinamide (PZA) versus the World Health Organization (WHO) standard of care (SOC) treatment for tuberculosis meningitis (TBM).

NCT ID: NCT05382299 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

ASCENT-03
Start date: July 20, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

NCT ID: NCT05382286 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

ASCENT-04
Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

NCT ID: NCT05375851 Recruiting - Clinical trials for Generalized Anxiety Disorder

Digital Interventions as an Add-on Tool in Generalized Anxiety Disorder Treatment

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Background: Over the last several years, there has been an increase in the popularity and availability of mobile digital technologies. Many recent studies have evaluated a range of mobile digital mental health interventions (DMHIs). Smartphone applications, remote monitoring, tracking devices, and wearable computers such as smartwatches and virtual reality headsets are being widely used for these studies. Besides that, psychometric scales are being used to help psychiatrists to improve treatment outcomes. The systematic administration of symptom rating scales and other assessment tools to help treatment decisions has been called measurement-based care (MBC) and it has shown good results in improving outcomes and time to response/remission of psychiatric diseases. As there is little data regarding MBC in Generalized Anxiety Disorder (GAD), the investigators decided to put technology and MBC together to study an easy and accessible way to improve the GAD usual treatment. Objectives: The aim of this study is to evaluate the benefit of digital interventions as an add-on tool to "treatment-as-usual" (TAU) in GAD patients. Methods: A twelve-weeks randomized clinical trial will be performed with 60 GAD patients. The control group will receive TAU, defined as 30-minutes online consultation with a trained psychiatrist, consisting in symptoms evaluation, general orientations about the disorder and use of medication. The consultations are going to occur biweekly. The digital intervention group (active group) will receive TAU, associated with two digital tools. The first one consists of psychoeducational videos to be seen between the sessions and the second one includes self-application of GAD-7 scale the day before the next scheduled consultation. All these digital interventions are going to be accessed in a mobile application, called "+PSI", that is already available in Apple Store and Google Play. The participants are going to be instructed to download the application on their mobile phones for free. The videos are going to be created especially for this project and will use animations and educational content, being of short duration (average 3 minutes). GAD-7 scale, and Hamilton Anxiety Scale (HAM-A) are going to be applied at baseline and at the end of the follow up by a blind rater. The investigators are also going to test the application tools usability using the System Usability Scale (SUS). Intermediate and follow-up evaluations will be performed to assess the speed and maintenance of improvement, respectively.

NCT ID: NCT05375799 Recruiting - COVID-19 Clinical Trials

Clinical and Electronic Record for Patients With COVID-19 Treated With the Assisted Breathing Helmet - ELMO in Ceará

COVID-19
Start date: September 1, 2021
Phase:
Study type: Observational [Patient Registry]

Continuous positive airway pressure (CPAP) with a helmet-like interface has been described as a safe strategy, with minimal contamination of the environment, improving the oxygenation of patients with acute respiratory failure (ARF) by COVID-19, avoiding intubation in more than half of the cases. ELMOcpap, developed in Ceará, was a great ally in the treatment of these cases during the pandemic in the state. It is estimated that among public and private services, more than 1.400 ELMOs have been applied to patients with COVID-19. However, the determining factors of the success and failure of its use in the different institutions in which it has been applied are still unknown. Therefore, it is necessary to survey all data associated with the use of the device. Objectives: 1. To describe the effects of ELMO in the treatment of patients with hypoxemic respiratory failure due to COVID-19 in a database, in a systematic and standardized way, on clinical history, efficacy, safety, modes, duration of use, the occurrence of adverse events and early predictors of failure. 2. Determine the intubation rate of patients with COVID-19 hypoxemic respiratory failure who used the ELMO. 3. Identify the mortality rate of patients with hypoxemic respiratory failure due to COVID-19 who used the ELMO. Methods: This is a retrospective, multicenter, observational, cohort study of recorded data from patients with COVID-19 hypoxemic respiratory failure who were treated with the ELMO. An online electronic form will be developed with REDCap, where the responsible investigator of each institution will be responsible for filling in the participants' data, ensuring adherence to the protocol and analysis will be carried out of the data of the patients of the participating services of the research that used the ELMO as treatment.

NCT ID: NCT05375422 Recruiting - Clinical trials for Rheumatoid Arthritis

Effects of SARAH Protocol in Women With Rheumatoid Arthritis

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to analyze the effect of the SARAH protocol, which is a set of exercises with components of muscle strengthening, range of motion gain and home exercises, combined with an educational intervention, on hand function in women with rheumatoid arthritis (RA).

NCT ID: NCT05374863 Recruiting - Clinical trials for Chronic Renal Diseases

Intradialytic Physiotherapy in Patients With Chronic Kidney Disease

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The objective is to evaluate in adult patients with chronic kidney disease the effect of neuromuscular electrical stimulation (NMES) in the upper limbs associated with a cycle ergometer in the lower limbs, during hemodialysis, on functional capacity and peripheral muscle strength. The hypothesis is that in people with chronic kidney disease on hemodialysis, the addition of neuromuscular electrical stimulation in the upper limbs associated with aerobic training of the lower limbs is superior to aerobic exercise alone in improving functional capacity, peripheral muscle strength, quality of life, safety intervention and patient adherence.

NCT ID: NCT05374512 Recruiting - Breast Cancer Clinical Trials

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

Start date: May 16, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

NCT ID: NCT05371613 Recruiting - Clinical trials for Mucopolysaccharidosis II

A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

COMPASS
Start date: July 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II). Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria.

NCT ID: NCT05364697 Recruiting - Clinical trials for Cardiovascular Diseases

IonMAN Trial- First In Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System

IonMAN
Start date: August 30, 2022
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, single-arm, open-label, First in Human clinical trial to provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system.