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Treatment In Thoracic Aortic Aneurysm: Surgery Vs Surveillance

Rochester, MN
- See Details
Treatment In Thoracic Aortic Aneurysm: Surgery Vs Surveillance
- 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:
  0
  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 ascending aorta conducts blood from the heart to the rest of the body. The ascending aorta can become enlarged, and the risk of tearing and rupturing becomes higher with larger aorta. When the ascending aorta tears or ruptures, the risk dying is high even if surgery is done as soon as possible. Traditionally, when the ascending aorta gets above 5.5 cm, surgery is recommended to replace the aorta. However, this threshold is based relatively weak evidence, and sometimes patients with smaller aorta can tear or rupture. On the other hand, surgery carries its own risk as well. Since there are risk of waiting or doing surgery, there is currently no great support for either approach for patients with a smaller aorta. In the TITAN SvS trial, patients with an ascending aorta between 5.0 to 5.5 cm is assigned by chance to the early surgery group, in which they will undergo replacement of aorta, or the surveillance group, in which they will be closely monitored. The chance of dying or suffer tearing or rupture of aorta between the two groups will be compared. The result of the trial will guide future practice for patients with enlarged ascending aorta.

This is a prospective, multi-centre randomized control trial that compares the all-cause mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those patients undergoing early elective ascending aortic surgery to those patients undergoing surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion criteria will be randomized to the early elective surgery group or the surveillance group. Recruitment will end when the desired sample size is reached, and the patients will be followed for a minimum 2-year period. The primary objective of the trial is to compare the composite outcome of the all-cause mortality and incidence of acute aortic events between surveillance and elective ascending aortic surgery for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up. The hypothesis is that the early surgery group will have a significantly lower all-cause mortality and incidence of acute aortic events at 2 years of follow up compare to the surveillance group. The result of this trial will provide evidence based guidance in the appropriate management of ascending aortic aneurysm based on the size criteria, and establish a large database for future investigations.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Open for enrollment
View complete study & contact information

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Site IRB:
23-001854

NCT ID:
NCT03536312
A Study To Test The Effect Of BI 456906 On Cardiovascular Safety In People With Overweight Or Obesity (SYNCHRONIZE™ - CVOT)

Rochester, MN
- See Details
A Study To Test The Effect Of BI 456906 On Cardiovascular Safety In People With Overweight Or Obesity (SYNCHRONIZE™ - CVOT)
- 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 trial is to evaluate the effect of treatment with BI 456906 3.6 and 6.0 mg once weekly versus (vs.) placebo on cardiovascular (CV) safety as an adjunct to standard of care for CV risk reduction, a reduced-calorie diet, and increased physical activity in trial participants with body mass index (BMI) ≥27 kg/m^2 with either established cardiovascular disease (CVD) or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.

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:
23-006156

NCT ID:
NCT06077864

Sponsor Protocol Number:
1404-0040

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

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

Study Of EO-3021 In Adult Patients With Solid Tumors Likely To Express CLDN18.2

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

See Details

Study Of EO-3021 In Adult Patients With Solid Tumors Likely To Express CLDN18.2

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:
1
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 determine the single-agent EO-3021 recommended phase 2 dose (RP2D) and schedule for further exploration in patients with advanced solid tumors that are likely to express CLDN18.2.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

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

Print study details

Site IRB:
23-008280
NCT ID:
NCT05980416
Sponsor Protocol Number:
ELVCAP-002-01

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed 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
Rochester, MN	Closed 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
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
Rochester, MN	Closed for enrollment

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Search Results 3951-3960 of 8977

Treatment In Thoracic Aortic Aneurysm: Surgery Vs Surveillance

A Study To Test The Effect Of BI 456906 On Cardiovascular Safety In People With Overweight Or Obesity (SYNCHRONIZE™ - CVOT)

Study Of EO-3021 In Adult Patients With Solid Tumors Likely To Express CLDN18.2

Phase 2b Study To Investigate The Safety And Efficacy Of TIN816 In Sepsis-associated Acute Kidney Injury (SA-AKI)

Efficacy, Safety And Tolerability Of VS-01 In Adult Patients With Acute-on-Chronic Liver Failure And Ascites (UNVEIL-IT)®

Metformin As A Chemoprevention Agent In Non-small Cell Lung Cancer

Evaluation Of Long Term Safety And Efficacy Of Glepaglutide In Treatment Of SBS - Extension Trial

Modified VR-CAP And Acalabrutinib As First Line Therapy For The Treatment Of Transplant-Eligible Patients With Mantle Cell Lymphoma

Comparative Effectiveness Of MRgFUS Versus CTgRFA For Osteoid Osteomas

Phase 2 Trial Of Adagrasib Monotherapy And In Combination With Pembrolizumab And A Phase 3 Trial Of Adagrasib In Combination In Patients With A KRAS G12C Mutation KRYSTAL-7

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