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CraniSeal Post Approval Study

Jacksonville, FL, Rochester, MN
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CraniSeal Post Approval Study
- 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:
  4
  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

To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Open for enrollment
View complete study & contact information

Jacksonville, Fla.

Open for enrollment

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Site IRB:
Rochester, Minnesota: 24-005310
Jacksonville, Florida: 24-005310

NCT ID:
NCT06406790
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Rochester, MN
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ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
- 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.
About this study

The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Closed for enrollment
View complete study & contact information

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Site IRB:
Rochester, Minnesota: 22-004385

NCT ID:
NCT05172960

Sponsor Protocol Number:
2021-05

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

Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

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

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Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

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:
2/3
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

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 17-011220
- Jacksonville, Florida: 17-011220
- Scottsdale/Phoenix, Arizona: 17-011220
NCT ID:
NCT03435796
Sponsor Protocol Number:
GC-LTFU-001

A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification

Rochester, MN
- See Details
A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification
- 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 primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis. Secondary and tertiary objectives are to determine whether Ataciguat slows progression of aortic valve function, reduces systemic inflammation, and prevents left ventricular dysfunction in patients with moderate calcific aortic valve stenosis.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Closed for enrollment
View complete study & contact information

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Site IRB:
Rochester, Minnesota: 14-006469

NCT ID:
NCT02481258

Sponsor Protocol Number:
14-006469
Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain

Jacksonville, FL
- See Details
Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain
- 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.
About this study

The purpose of this study is to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain; to investigate the effectiveness of HIFU, using the Neurolyser XR, in a rigorous randomized double-blind sham-controlled fashion. This study will allow the evaluation of a portable, non-invasive and simple to use HIFU method guided by a routine fluoroscopy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Closed for enrollment
View complete study & contact information

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Site IRB:
Jacksonville, Florida: 22-006366

NCT ID:
NCT05154448

Sponsor Protocol Number:
LBP003

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

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

A Study to Compare the Effectiveness and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM)

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

See Details

A Study to Compare the Effectiveness and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM)

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 compare the effectiveness and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information
Jacksonville, Fla.	Closed for enrollment
Rochester, Minn.	Closed for enrollment

Print study details

Site IRB:
- Scottsdale/Phoenix, Arizona: 18-008956
- Jacksonville, Florida: 18-008956
- Rochester, Minnesota: 18-008956
NCT ID:
NCT03651128
Sponsor Protocol Number:
BB2121-MM-003

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information
Scottsdale/Phoenix, Ariz.	Contact us for the latest status

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

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Search Results 4201-4210 of 10862

CraniSeal Post Approval Study

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification

Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain

A Study to Compare the Effectiveness and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM)

Validation of Pediatric Inflammatory Bowel Disease Knowledge Questions (Emma)

BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants (PATAPSCO)

Arimoclomol Prospective Study in Patients Diagnosed With NiemannPick Disease Type C

Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

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