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The ExTINGUISH Trial Of Inebilizumab In NMDAR Encephalitis (ExTINGUISH)

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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The ExTINGUISH Trial Of Inebilizumab In NMDAR Encephalitis (ExTINGUISH)

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to define the effectiveness and safety of Inebilizumab in reducing the level of disability in patients with NMDAR encephalitis as measured by modified Rankin score (mRS).

There are currently no medicinal products approved for the treatment of anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis, a rare disease. NMDAR encephalitis is a life‑threatening, antibody-mediated autoimmune disorder of the central nervous system. Standard of care includes high-dose corticosteroids AND either intravenous immunoglobulin (IVIg) OR plasmapheresis. However, as many as 47% of patients may fail to respond to initial treatment at 4 weeks, thus, there is a high unmet medical need for more effective therapies.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
21-010340
NCT ID:
NCT04372615

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Rochester, MN	Closed for enrollment

Mayo Clinic Location	Status	Contact
Rochester, MN	Open for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Open for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Sonocloud-9 In Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU Or TMZ) In Recurrent GBM

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Sonocloud-9 In Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU Or TMZ) In Recurrent GBM

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Contact us for the latest status	View complete study & contact information
Jacksonville, FL	Contact us for the latest status
Rochester, MN	Contact us for the latest status

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Site IRB:
24-000548
NCT ID:
NCT05902169
Sponsor Protocol Number:
SC9-GBM-03

A Study To Compare Letrozole With Or Without Paclitaxel And Carboplatin In Treating Patients With Stage II-IV Ovarian Or Primary Peritoneal Cancer

Albert Lea, MN, Rochester, MN
- See Details
A Study To Compare Letrozole With Or Without Paclitaxel And Carboplatin In Treating Patients With Stage II-IV Ovarian Or Primary Peritoneal Cancer
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  3
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this study is to evaluate how well letrozole, with or without paclitaxel and carboplatin, works in treating patients with stage II-IV low-grade serous carcinoma of the ovary or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary or peritoneum compared to paclitaxel and carboplatin without letrozole.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Albert Lea, MN

Closed for enrollment
View complete study & contact information

Rochester, MN

Closed for enrollment

Print study details
Site IRB:
19-009074

NCT ID:
NCT04095364

Sponsor Protocol Number:
NRG-GY019
Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study In Symptomatic Celiac Disease Patients

Rochester, MN
- See Details
Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study In Symptomatic Celiac Disease Patients
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a gluten free diet (GFD) for at least one year prior to screening.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Closed for enrollment
View complete study & contact information

Print study details
Site IRB:
19-007942

NCT ID:
NCT04243551

Sponsor Protocol Number:
IMGX003-NIAID-1821

Mayo Clinic Location	Status	Contact
Albert Lea, MN	Closed for enrollment	View complete study & contact information
Rochester, MN	Closed for enrollment

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

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Search Results 931-940 of 11585

The ExTINGUISH Trial Of Inebilizumab In NMDAR Encephalitis (ExTINGUISH)

A Study Of TAK-062 In Treatment Of Active Celiac Disease In Participants Attempting A Gluten-Free Diet

Phase III DAS181 Lower Tract PIV Infection In Immunocompromised Subjects (Substudy: DAS181 For COVID-19): RCT Study

Endurant Stent Graft System Vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial In Sac Regression (ADVANCE Trial)

Study Of Bcl-2 Inhibitor BGB-11417 In Participants With Mature B-Cell Malignancies

SC Versus IV Isatuximab In Combination With Pomalidomide And Dexamethasone In RRMM

A Study to Evaluate Molecular Mechanisms of Exercise Benefits in Insulin Resistant People

Sonocloud-9 In Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU Or TMZ) In Recurrent GBM

A Study To Compare Letrozole With Or Without Paclitaxel And Carboplatin In Treating Patients With Stage II-IV Ovarian Or Primary Peritoneal Cancer

Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study In Symptomatic Celiac Disease Patients

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