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NCT ID: NCT05139316 Active, not recruiting - Clinical trials for Glycogen Storage Disease Type IA

A Study of Adeno-Associated Virus Serotype 8-Mediated Gene Transfer of Glucose-6-Phosphatase in Patients With Glycogen Storage Disease Type Ia (GSDIa)

Start date: November 8, 2021
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of DTX401 to reduce or eliminate dependence on exogenous glucose replacement therapy to maintain euglycemia and to maintain or improve the quality of glucose control.

NCT ID: NCT05138133 Recruiting - Lupus Nephritis Clinical Trials

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

IRIS
Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

NCT ID: NCT05135494 Completed - Stroke Clinical Trials

Effects of Inspiratory Muscle Training on the Severity of Obstructive Sleep Apnea in Individuals After Stroke

Start date: November 30, 2021
Phase: N/A
Study type: Interventional

The prevalence of Obstructive Sleep Apnea (OSA) is high in individuals after a stroke. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on Apneia/Hipopneia Index (AHI) reduction are still controversial. This study will test the hypothesis that training of the inspiratory muscles is effective in improving severity of OSA, sleep quality and daytime sleepiness in individuals after stroke participating in a rehabilitation program. Methods: For this prospective, sigle blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy, speech therapy and aerobic exercise sessions. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures. Study outcomes: Primary outcome will be OSA severity measured using the Apnea/Hypopnea Index (AHI). Secondary outcomes will include inspiratory endurance and pressure, functional independence, sleep quality and daytime sleepiness

NCT ID: NCT05133609 Recruiting - Clinical trials for SARS-CoV-2 Infection

COVID-19 VACCINE SAFETY AND EFFECTIVENESS

Start date: January 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

A longitudinal open-label study will include health professionals and patients with immune-mediated inflammatory diseases (IMID) who will receive the ChAdOx1 nCoV-19 vaccine (AZD1222), in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-thrid dose), in the vaccination campaign against SARS-CoV-2 to assess the safety, efficacy and duration of the short- and long-term humoral and cellular immune response after vaccination for COVID-19 and compare the vaccine response between individuals who have or have not had previous SARS-Cov 2 infection.

NCT ID: NCT05132582 Recruiting - Clinical trials for HER2 Positive Breast Cancer

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

HER2CLIMB-05
Start date: March 7, 2022
Phase: Phase 3
Study type: Interventional

This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

NCT ID: NCT05128448 Active, not recruiting - Clinical trials for Posterior Shoulder Tightness

Comparative Effects of Two Procedures for the Management of Posterior Shoulder Tightness

Start date: October 17, 2021
Phase: N/A
Study type: Interventional

This study aims to compare the effects of a self-stretch procedures versus a clinician applied musculoskeletal procedure in individuals with posterior shoulder tightness.

NCT ID: NCT05126628 Completed - COVID-19 Clinical Trials

The South Proxa-Rescue AndroCoV Trial Against COVID-19

Start date: March 6, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy of proxalutamide or hospitalized moderate-to-severe COVID-19 patients.

NCT ID: NCT05126576 Suspended - COVID-19 Clinical Trials

Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19

MORNINGSKY
Start date: April 28, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.

NCT ID: NCT05126277 Recruiting - Lupus Nephritis Clinical Trials

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

SIRIUS-LN
Start date: July 14, 2022
Phase: Phase 3
Study type: Interventional

This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

NCT ID: NCT05124626 Recruiting - Funnel Chest Clinical Trials

Evaluation of Chest Wall Motility After MIRPE

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

Pectus excavatum (PE) is the most common congenital deformity of the chest wall and surgical treatment using the minimally invasive technique (MIRPE) is consolidating as the choice to perform PE correction. In this technique, a temporary metal bar is placed in a retrosternal position, pushing the sternum without the need for cartilage resection. Despite the advantages obtained, it is not free from complications, with the displacement of the bar being one of the main problems. Therefore, the aim of this study is to evaluate a new bridging device for the set of two metal bars to be used in the surgical treatment of PE, verifying the clinical and surgical complications and evaluating the change in lung volumes and thoracoabdominal kinematics using optoelectronic plethysmography , preoperatively and 180 days after MIRPE; and also evaluating diaphragmatic mobility via ultrasound examination to assess the craniocaudal displacement of the left branch of the vein preoperatively and 180 days later. There will be 20 participants, who after performing a computed tomography of the chest to obtain the Haller index, clinical and laboratory tests, electrocardiogram and echocardiogram. Participants will be randomized and divided into two groups: 10 control individuals (traditional MIRPE technique used in the Service) and 10 intervention individuals (with bridge fixators developed in partnership with Traumec Tecnologia e Implantes, Brazil). The effectiveness of the fixators will be evaluated by the degree of displacement of the bars, using a mathematical formula, using a lateral chest X-ray in the immediate postoperative period (d0) and another image from the end of the period analyzed (dX), 15, 30, 90 and 180 days after the surgical procedure; evaluation of postoperative pain through the numerical pain scale; use of validated questionnaires on quality of life (physical and mental health) using two instruments, SF-36 and PEEQ. All data obtained between the two groups will be submitted to descriptive and inferential statistics.