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NCT ID: NCT04851015 Not yet recruiting - Clinical trials for Pneumocystis Pneumonia

Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia

LOW-TMP
Start date: June 2022
Phase: Phase 3
Study type: Interventional

Pneumocystis jirovecii pneumonia (PJP) is an opportunistic fungal infection of immunocompromised hosts which causes in significant morbidity and mortality. The current standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day of TMP, is associated with serious adverse events, including hypersensitivity reactions, drug-induced liver injury, cytopenia, and renal failure occurring among 20-60% of patients. The frequency of adverse events increases in a dose dependent manner and commonly limits the use of TMP-SMX. Reduced treatment doses of TMP-SMX for PJP reduced ADEs without mortality differences in a recent meta-analysis of observational studies. We therefore propose a Phase III randomized, placebo-controlled trial to directly compare the efficacy and safety of low dose (10 mg/kg/day of TMP) compared to the standard-of-care (15 mg/kg/day) among patients with PJP for the primary outcome of death, new mechanical ventilation, and change of treatment.

NCT ID: NCT04850833 Recruiting - Clinical trials for Cognitive Impairment (CI)

Post-operative Functional Disability in Unrecognized Cognitive Impairment (POF) Study

Start date: July 25, 2021
Phase:
Study type: Observational

This is a prospective multicenter cohort study, which will determine the prevalence of preoperative cognitive impairment (CI) using the Modified Telephone Interview for Cognitive Status (TICS- M), Eight-items interview to Differentiate Aging and Dementia (AD8), Telephone Montreal Cognitive Assessment (T-MoCA), and a single cognitive question from the Centers for Disease Control and Prevention (CDC). We would determine the (1) the diagnostic accuracy (sensitivity, specificity, and area under the curve (AUC)) of the AD8, CDC single cognitive question, and T-MoCA against the TICS-M and (2) the correlation between CI and measures of postoperative delirium, sleep disturbances, functional disability, instrumental activities of daily living (IADL), depression, quality of health, frailty, and pain in older surgical patients. This study will target older patients from the pre-operative clinics at Toronto Western Hospital and Mount Sinai Hospital (MSH), Toronto. Research staff will identify eligible patients who are scheduled for elective non-cardiac surgery. Written informed consent to participate in the study will be obtained from all patients.

NCT ID: NCT04850820 Completed - Exercise Clinical Trials

Impact of Amino Acids to Enhance Anabolism After Home-based Exercise

B2B
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

An adequate quantity of lean body mass is vital for optimal health and performance, and is accrued when net protein balance (NPB) is positive. Amino acids are the building blocks of protein, and when consumed following resistance exercise, significantly improve NPB. However, no study has investigated how a supplement of all of the essential amino acids (EAA) affects NPB following resistance exercise in a free-living, home-based setting, particularly when compared to a supplement of branched-chain amino acids (BCAA). Therefore, the purpose of this study is to determine the impact of a novel EAA supplement on anabolism (e.g., NPB) as compared to BCAA and placebo supplements following home-based resistance exercise.

NCT ID: NCT04850508 Completed - Atrial Fibrillation Clinical Trials

Validation of the Advisor HD Grid Mapping Catheter in Atrial Fibrillation Ablation

Start date: September 27, 2021
Phase:
Study type: Observational

The primary study concept is to evaluate the superiority of the HD Grid high-density mapping catheter over the current standard 20-pole circular mapping catheter in pulmonary vein isolation (PVI) in atrial fibrillation. A minimum of 20 evaluable subjects with symptomatic atrial fibrillation scheduled for a clinically indicated first PVI ablation will be included.

NCT ID: NCT04850105 Recruiting - Clinical trials for Hereditary Transthyretin Amyloidosis With Polyneuropthy

A Non-interventional Cohort Safety Study of Patients With hATTR-PN

Start date: September 21, 2021
Phase:
Study type: Observational

This is a prospective, non-interventional, Long-term, multinational cohort safety study of patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN). The overarching goal of this study is to further characterize the long-term safety of TEGSEDI (inotersen) in patients with hATTR-PN under real-world conditions.

NCT ID: NCT04849910 Recruiting - Clinical trials for Myelodysplastic Syndromes

Allogeneic Engineered Hematopoietic Stem Cell Transplant (HCT) Lacking the CD33 Protein, and Post-HCT Treatment With Mylotarg, for Patients With CD33+ AML or MDS

Start date: December 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2a, multicenter, open-label, first-in-human (FIH) study of VOR33 in participants with AML or MDS who are undergoing human leukocyte antigen (HLA)-matched allogeneic hematopoietic cell transplant (HCT).

NCT ID: NCT04849741 Recruiting - Alexander Disease Clinical Trials

A Study to Evaluate the Safety and Efficacy of ION373 in Patients With Alexander Disease (AxD)

Start date: June 1, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of zilganersen (ION373) in improving or stabilizing gross motor function across the full range of affected domains in patients with AxD.

NCT ID: NCT04849728 Recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

NATiV3
Start date: August 19, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

NCT ID: NCT04849299 Completed - Clinical trials for Healthy Volunteer Study

Effect of Cyclosporine on the Pharmacokinetics (PK) of AT-527 (R07496998)

Start date: April 18, 2021
Phase: Phase 1
Study type: Interventional

This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in healthy male subjects

NCT ID: NCT04848909 Active, not recruiting - Prostate Cancer Clinical Trials

Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy

PLUTO-MPC
Start date: June 3, 2021
Phase: N/A
Study type: Interventional

This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.