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NCT ID: NCT04540497 Active, not recruiting - Clinical trials for IgG4 Related Disease

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

Start date: October 26, 2020
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).

NCT ID: NCT04540302 Active, not recruiting - Venous Occlusion Clinical Trials

The Merit WRAPSODY AV Access Efficacy Study (WAVE)

WAVE
Start date: March 9, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit

NCT ID: NCT04540276 Active, not recruiting - Clinical trials for Myocardial Infarction

Intraoperative Hyperoxia and MINS

Start date: February 4, 2018
Phase:
Study type: Observational

Oxygen therapy is administered to all patients during general anesthesia to maintain tissue oxygenation and prevent hypoxia and ischemia. However, liberal use of oxygen may lead to hyperoxia and some studies suggest that supranormal levels of arterial oxygen saturation may lead to complications. In this post hoc substudy of the VISION cohort, we plan to assess the association between perioperative inspired oxygen fraction (FiO2) and myocardial injury after non-cardiac surgery (MINS).

NCT ID: NCT04539964 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

RESET-RA
Start date: January 11, 2021
Phase: Phase 3
Study type: Interventional

The RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll 250 subjects at 40 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 180-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.

NCT ID: NCT04539938 Active, not recruiting - Clinical trials for HER2 Positive Breast Cancer

A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

HER2CLIMB-04
Start date: December 1, 2020
Phase: Phase 2
Study type: Interventional

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.

NCT ID: NCT04539574 Active, not recruiting - Glioma Clinical Trials

An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors

Start date: September 4, 2020
Phase: N/A
Study type: Interventional

This trial investigates how well 7T MRI scan works in imaging central nervous system tumors. Diagnostic procedures, such as 7T MRI, may help find and diagnose central nervous system tumors and help measure a patient's response to earlier treatment. The goal of this trial is to learn if a new MRI system can provide better quality images than a standard MRI.

NCT ID: NCT04539041 Active, not recruiting - Clinical trials for Progressive Supranuclear Palsy (PSP)

Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of NIO752 in Progressive Supranuclear Palsy

Start date: February 16, 2021
Phase: Phase 1
Study type: Interventional

This is a phase 1, multi-center, double-blind, placebo-controlled, multiple dose escalation study with NIO752 in progressive supranuclear palsy (PSP) participants.

NCT ID: NCT04538742 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

DB-07
Start date: December 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer

NCT ID: NCT04538664 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

PAPILLON
Start date: October 13, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.

NCT ID: NCT04538625 Active, not recruiting - Adult Solid Tumor Clinical Trials

Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

OnTARGET
Start date: October 7, 2020
Phase: Phase 3
Study type: Interventional

A 24-week, (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens. Diarrhea grading will be done according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Patients will be randomized 1:1 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type. Placebo and/or crofelemer will be dispensed at Visit 1/Day 1 with the concurrent start of the targeted cancer therapy regimen. The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles. The Primary and Secondary Endpoints will be analyzed after the last patient last visit (LPLV) of Stage I. After completing the Stage I double-blind, placebo-controlled primary treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, visit 5 will be the last study visit.