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NCT ID: NCT05568719 Recruiting - Hemophilia A Clinical Trials

Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively

Start date: December 28, 2022
Phase: Phase 3
Study type: Interventional

A study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia A or hemophilia B respectively, who have received treatment through prior participation in a Pfizer-sponsored clinical trial. Data collection and participant visits will be based on standard of care.

NCT ID: NCT05566795 Recruiting - Low-grade Glioma Clinical Trials

DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

Start date: February 27, 2023
Phase: Phase 3
Study type: Interventional

This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.

NCT ID: NCT05565430 Recruiting - Asthma Clinical Trials

Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe Asthmatics.

Start date: June 1, 2018
Phase:
Study type: Observational

The Investigators aim to: 1. Study the effect of hyperventilation on the development of paradoxical vocal cord movement (PVCM) in healthy individuals and in patients with mild and severe asthma, 2. Relate PVCM to airway symptoms and measurements of intra- and extra-thoracic airway hyperresponsiveness (ET-AHR), 3. Evaluate the effects of inhaled anti-cholinergic agents on PVCM induced by hyperventilation. Hypotheses: 1. In health PVCM will not occur in response to hyperventilation, 2. In asthma PVCM will occur in response to hyperventilation, 3. Airway symptoms and ET-AHR will develop in parallel with PVCM, 4. Inhaled anticholinergic agents will prevent PVCM induced by hyperventilation.

NCT ID: NCT05564754 Recruiting - Hypoxia, Brain Clinical Trials

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

STEPCARE
Start date: August 17, 2023
Phase: N/A
Study type: Interventional

The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.

NCT ID: NCT05560659 Recruiting - Clinical trials for Oligometastatic Prostate Cancer

Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy

POPSTAR II
Start date: December 14, 2023
Phase: Phase 2
Study type: Interventional

The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.

NCT ID: NCT05559580 Recruiting - Clinical trials for Scleroderma, Systemic

A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms

VITALISScEā„¢
Start date: November 24, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.

NCT ID: NCT05559359 Recruiting - Atopic Dermatitis Clinical Trials

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

ADorable-1
Start date: October 18, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT05558605 Recruiting - Heart Failure Clinical Trials

Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment

AGILE-Echo
Start date: February 24, 2023
Phase: N/A
Study type: Interventional

Heart Failure and valvular heart disease are disproportionate problems in rural and remote Australia (RRA). Echocardiography is the best imaging investigation, and essential for management, but access to this essential test shows huge geographic variations, primarily because of dependence on expert acquisition. This trial seeks to demonstrate the effectiveness of artificial intelligence-based echocardiography for triage and management of patients with known or suspected heart disease in RRA.

NCT ID: NCT05558371 Recruiting - Clinical trials for CDKL5 Deficiency Disorder

International CDKL5 Clinical Research Network

ICCRN
Start date: February 15, 2021
Phase:
Study type: Observational

Pathogenic variants in the Cyclin-dependent kinase like 5 (CDKL5) gene cause CDKL5 deficiency disorder (CDD, MIM 300672, 105830), a severe developmental and epileptic encephalopathy associated with cognitive and motor impairments and cortical visual impairment. While capability for disease modifying therapies is accelerating, there is a critical barrier for clinical trial readiness that may result in failure of these therapies, not due to lack of efficacy but due to lack of validated outcome measures and biomarkers. The measures and biomarkers validated here will be adaptable to other developmental and epileptic encephalopathies.

NCT ID: NCT05556720 Recruiting - Multiple Myeloma Clinical Trials

Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial

Start date: December 1, 2022
Phase: Phase 3
Study type: Interventional

Despite the greater risk of adverse COVID-19 outcomes, antibody and cell-mediated immune responses to COVID-19 vaccines vary amongst immunocompromised (IC) people and are poorly defined. IC hosts were largely excluded from the COVID-19 vaccine registration trials, though many countries recommend additional and booster doses of vaccination in this group. BOOST-IC is an adaptive randomised clinical trial (RCT) to assess the immunogenicity and safety of additional COVID-19 vaccine doses in immunocompromised (IC) people, including people with HIV, solid organ transplants (SOT) recipients or those with haematological malignancies. Briefly, the study aims to generate high-quality evidence on the immunogenicity and safety of alternative COVID-19 booster strategies against SARS-CoV-2 for IC people in Australia.