Clinical Trials

Radial Vs. State-Of-The-Art Femoral Access For Bleeding And Access Site Complication Reduction In Cardiac Catheterization (REBIRTH)

Jacksonville, FL

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Radial Vs. State-Of-The-Art Femoral Access For Bleeding And Access Site Complication Reduction In Cardiac Catheterization (REBIRTH)

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

The purpose of this study is to compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.

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: 23-004258
NCT ID:
NCT04077762
Sponsor Protocol Number:
REBIRTH Version 5

A Study To Evaluate ORIN1001 In Idiopathic Pulmonary Fibrosis Subjects

Jacksonville, FL

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A Study To Evaluate ORIN1001 In Idiopathic Pulmonary Fibrosis Subjects

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 evaluate the safety profile and tolerability of ORIN1001 alone and/or in combination with the local standard of care (SOC) in adult subjects with idiopathic pulmonary fibrosis (IPF).

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: 21-005225
NCT ID:
NCT04643769
Sponsor Protocol Number:
ORIN1001-002

An Open-label Extension Trial Of The Effectiveness And Safety Of CVL-865 To Treat Focal Onset Seizures.

Jacksonville, FL

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An Open-label Extension Trial Of The Effectiveness And Safety Of CVL-865 To Treat Focal Onset Seizures.

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 assess the long-term safety and tolerability of CVL-865 as adjunctive therapy in participants with focal onset seizures.

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: 21-004972
NCT ID:
NCT04686786
Sponsor Protocol Number:
CVL-865-SZ-002

A Study Evaluating Efruxifermin In Subjects With Compensated Cirrhosis Due To NASH/MASH

Rochester, MN

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A Study Evaluating Efruxifermin In Subjects With Compensated Cirrhosis Due To NASH/MASH

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 evaluation of efruxifermin (EFX) in subjects with compensated cirrhosis due to NASH/MASH.

This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the clinical benefit and safety of EFX in subjects with compensated cirrhosis due to NASH/MASH.

The study will enroll in 2 cohorts. Cohort 1 will enroll approximately 750 subjects with biopsy-proven compensated cirrhosis due to NASH/MASH. Cohort 2 will enroll approximately 400 subjects with a clinical diagnosis of compensated cirrhosis due to NASH/MASH.
Evaluation of the clinical outcomes primary endpoint will occur when a pre-specified number of adjudicated events has been accrued, which is anticipated to be approximately 156 weeks. This time frame may be extended until the prespecified number of events has accrued.
A histology primary endpoint analysis will occur after all subjects in Cohort 1 have completed the Histology Primary Endpoint Treatment Duration (i.e., completed 96 weeks of treatment or permanently discontinued from the study prior to Week 96). For evaluation of longer-term safety and efficacy, all subjects will continue to receive their assigned treatment until the pre-specified number of adjudicated events has been accrued.
Subjects meeting the study’s eligibility criteria will be randomly assigned in a 1:1 ratio into 1 of 2 treatment groups.

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

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Site IRB:
- Rochester, Minnesota: 24-009174
NCT ID:
NCT06528314
Sponsor Protocol Number:
AK-US-001-0106

A Study Of Adjunctive Ganaxolone Treatment In Children And Young Adults With CDKL5 Deficiency Disorder

Rochester, MN

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A Study Of Adjunctive Ganaxolone Treatment In Children And Young Adults With CDKL5 Deficiency Disorder

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

A clinical study to evaluate the effectiveness, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.

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: 18-006148
NCT ID:
NCT03572933
Sponsor Protocol Number:
1042-CDD-3001

An Open-Label Roll-Over Study To Evaluate The Long-Term Safety And Efficacy Of DCR-PHXC Solution For Injection (Subcutaneous Use) In Patients With Primary Hyperoxaluria

Rochester, MN

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An Open-Label Roll-Over Study To Evaluate The Long-Term Safety And Efficacy Of DCR-PHXC Solution For Injection (Subcutaneous Use) In Patients With Primary Hyperoxaluria

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 the long-term effectiveness and safety of DCR-PHXC in children and adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2) that have completed a previous DCR-PHXC clinical trial.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed-enrolling by invitation What is this? (?)	View complete study & contact information

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Closed-enrolling by invitation

View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 18-011726
NCT ID:
NCT04042402
Sponsor Protocol Number:
DCR-PHXC-301

A Study To Evaluate Imaging And Pathology Correlation For Duodenal Biopsies Using Fujifilm Device

Rochester, MN

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A Study To Evaluate Imaging And Pathology Correlation For Duodenal Biopsies Using Fujifilm Device

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 purpose of this study is to match endoscopic images with standard of care endoscopic biopsies to determine if the images can diagnose as effective as biopsies for duodenal/small bowel biopsies.

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: 19-005311
Sponsor Protocol Number:
19-005311

A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial To Demonstrate The Efficacy And Safety Of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via The PARI Investigational EFlow® Device Plus Standard Of Care Versus Standard Of Care Alone In The Treatment Of Chronic Lung Allograft Syndrome / Bronchiolitis Obliterans Syndrome In Patients Post Double Lung Transplantation (BOSTON-2)

Jacksonville, FL

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A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial To Demonstrate The Efficacy And Safety Of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via The PARI Investigational EFlow® Device Plus Standard Of Care Versus Standard Of Care Alone In The Treatment Of Chronic Lung Allograft Syndrome / Bronchiolitis Obliterans Syndrome In Patients Post Double Lung Transplantation (BOSTON-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:
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 L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following double-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.

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: 19-004406
NCT ID:
NCT03657342
Sponsor Protocol Number:
BT - L-CsA - 302 - DLT

A Study To Evaluate The Safety And Effectiveness Of Endoluminal Clinical Treatment Of Gastroesophageal Reflux Disease

Jacksonville, FL

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A Study To Evaluate The Safety And Effectiveness Of Endoluminal Clinical Treatment Of Gastroesophageal Reflux Disease

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 purpose of this study is to demonstrate the safety and effiectiveness of Aluvra for the treatment of GERD.

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

Print study details

Site IRB:
- Jacksonville, Florida: 18-008948
NCT ID:
NCT03090607
Sponsor Protocol Number:
NECTAR

A Study To Evaluate Mitral Implantation Of Transcatheter Valves

Rochester, MN

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A Study To Evaluate Mitral Implantation Of Transcatheter Valves

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 enroll high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease. There are 2 arms in this study: Transseptal Valve-in-MAC (ViMAC) and a control arm of patients treated with medical treatment only which will include patients who can't be treated due to the presence of anatomical exclusion criteria or other exclusion criteria.

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

Print study details

Site IRB:
- Rochester, Minnesota: 20-010096
NCT ID:
NCT04408430
Sponsor Protocol Number:
20-010096

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Search Results 5041-5050 of 11516

Radial Vs. State-Of-The-Art Femoral Access For Bleeding And Access Site Complication Reduction In Cardiac Catheterization (REBIRTH)

A Study To Evaluate ORIN1001 In Idiopathic Pulmonary Fibrosis Subjects

An Open-label Extension Trial Of The Effectiveness And Safety Of CVL-865 To Treat Focal Onset Seizures.

A Study Evaluating Efruxifermin In Subjects With Compensated Cirrhosis Due To NASH/MASH

A Study Of Adjunctive Ganaxolone Treatment In Children And Young Adults With CDKL5 Deficiency Disorder

An Open-Label Roll-Over Study To Evaluate The Long-Term Safety And Efficacy Of DCR-PHXC Solution For Injection (Subcutaneous Use) In Patients With Primary Hyperoxaluria

A Study To Evaluate Imaging And Pathology Correlation For Duodenal Biopsies Using Fujifilm Device

A Study To Evaluate The Safety And Effectiveness Of Endoluminal Clinical Treatment Of Gastroesophageal Reflux Disease

A Study To Evaluate Mitral Implantation Of Transcatheter Valves

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