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NCT ID: NCT05669989 Recruiting - Plasma Cell Myeloma Clinical Trials

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Start date: April 5, 2023
Phase: Phase 2
Study type: Interventional

- This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. - This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. - The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

NCT ID: NCT05669755 Recruiting - Clinical trials for Cardiovascular Disease

REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels

REDEFINE 3
Start date: March 1, 2023
Phase: Phase 3
Study type: Interventional

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.

NCT ID: NCT05669469 Completed - Obesity Clinical Trials

Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery

Start date: August 15, 2017
Phase:
Study type: Observational

Evaluation of upper airway with Magnetic Resonance and polysomnographic at the pre and post operative of 23 women having undergone bariatric surgery (with the Y-Roux technique) for treatment of obesity.

NCT ID: NCT05669014 Recruiting - Clinical trials for Idiopathic Inflammatory Myositis

A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)

Start date: December 4, 2023
Phase: Phase 2
Study type: Interventional

The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1. To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. 2. To evaluate the effect of daxdilimab compared with placebo on skin symptoms at Week 24. 3. To evaluate the effect of daxdilimab on decreasing the use of corticosteroid at Week 24. Other secondary objectives include: 1. To characterize the pharmacokinetics (PK) and immunogenicity of daxdilimab in participants. 2. To evaluate the safety and tolerability of daxdilimab in participants.

NCT ID: NCT05668988 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

Start date: December 13, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).

NCT ID: NCT05667844 Completed - Mood Disorders Clinical Trials

Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.

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

The interoception capacity may be changed with mind-body intervention. This study case investigated the interoceptive capacity, measured by MAIA scale of a pacient with mood disorders and if it can be influenced through of a 7 weeks intervention of interoceptive exercises and the impaction in the patient´s daily life. The aim was analyse the effects of mind-body exercise program with interoceptive approach in the anxiety and depression symptoms, interoceptive capacity, as well your impact in paitient's daily activities. M.S is 47 years old, was forwarded from University Hospital Clementino Fraga Filho to extension project named as "corpo&mente" (body-mind), an anamnesis was performed including patient's life story, interoceptive scale, anxiety and depression scale from Hamilton and a risk stratification to realize physical activities (it was also performed post-intervention). The exercise program lasted 1h 15 min and it was performed once a week.

NCT ID: NCT05665920 Recruiting - Clinical trials for Malignant Breast Neoplasm

Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy

HYPHEN
Start date: October 18, 2022
Phase: N/A
Study type: Interventional

The reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. Thus, as a reference Institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 Gy / 5 fractions in one week, in a controlled manner, through this project.The investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.

NCT ID: NCT05665595 Active, not recruiting - Melanoma Clinical Trials

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

Start date: January 19, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

NCT ID: NCT05665036 Withdrawn - MPS I Clinical Trials

Safety and Efficacy of Encapsulated Allogeneic MPS-1 Therapy

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

SIG-005-121 is a FIH, Phase 1/2, multi-centre, open-label, sequential dose-escalating study to assess the safety, tolerability, and preliminary efficacy of SIG-005 in adults with MPS-1. The study will evaluate up to three ascending dose levels of SIG-005 in male and female patients with attenuated MPS-1 (Scheie or Hurler-Scheie), 18 years of age or greater, who received Enzyme Replacement Therapy (ERT) for a minimum of 12 months prior to the study entry. Each cohort will include 3 patients.

NCT ID: NCT05663723 Not yet recruiting - Clinical trials for Peripheral Nervous System Diseases AND Breast Neoplasms

Photobiomodulation for Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer

Start date: January 10, 2023
Phase: N/A
Study type: Interventional

Double-blind Superiority Randomized Controlled Clinical Trial. Objective of the study: To evaluate the effectiveness of photobiomodulation using the LED board in the prevention of peripheral neuropathy in the lower limbs in women with breast cancer undergoing chemotherapy at the Cancer Hospital III of the National Cancer Institute (HCIII/INCA).