Clinical Trials

A Safety and Efficacy Study of Domvanalimab + Zimberelimab Combination Therapy in Participants With Advanced Upper Gastrointestinal Tract Malignancies

Scottsdale/Phoenix, AZ, Jacksonville, FL

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A Safety and Efficacy Study of Domvanalimab + Zimberelimab Combination Therapy in Participants With Advanced Upper Gastrointestinal Tract Malignancies

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 Phase 2, open-label, parallel, 3-cohort, multicenter study will evaluate the safety and efficacy of various combinations of the anti-T-cell immunoglobulin and ITM domain (TIGIT) monoclonal antibody domvanalimab, the anti-programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy in the first--line setting, and of various combinations of domvanalimab, zimberelimab, the cluster of differentiation 73 (CD73) inhibitor quemliclustat, and chemotherapy in the second-line (2L) or greater setting in participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

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
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Jacksonville, Florida: 22-004566
- Scottsdale/Phoenix, Arizona: 22-004566
NCT ID:
NCT05329766
Sponsor Protocol Number:
ARC-21

P1101 in Treating Patients With Myelofibrosis

Scottsdale/Phoenix, AZ

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P1101 in Treating Patients With Myelofibrosis

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 evaluate the effectiveness of P1101 (polyethyleneglycol [PEG]-proline-interferon alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a substance that can improve the body's natural response and may slow the growth of myelofibrosis.

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

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Site IRB:
- Scottsdale/Phoenix, Arizona: 14-001548
NCT ID:
NCT02370329
Sponsor Protocol Number:
MC138F

Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population

Rochester, MN

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Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population

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

Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high postoperative function. This approach has also been shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies. However, the only studies that directly compare two approaches for hip arthroplasty for femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA. The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our institution, so we are setting out to determine the differences between them.

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: 16-003695
NCT ID:
NCT02959320
Sponsor Protocol Number:
16-003695

Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System

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Primary Hyperoxaluria Mutation Genotyping/Phenotyping

Rochester, MN

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Primary Hyperoxaluria Mutation Genotyping/Phenotyping

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

Specific mutations relating to hyperoxaluria will be determined via DNA analysis by the Mayo RKSC research staff.

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: 13-006384
NCT ID:
NCT02340689
Sponsor Protocol Number:
6406

Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting

Rochester, MN

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Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting

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

Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma

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

Print study details

Site IRB:
- Rochester, Minnesota: 14-005906
NCT ID:
NCT02004262
Sponsor Protocol Number:
ADU-CL-04

SC16LD6.5 in Recurrent Small Cell Lung Cancer

Rochester, MN

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SC16LD6.5 in Recurrent Small Cell Lung 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:
1/2
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 safety and tolerability of SC16LD6.5 at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC's theoretically provide more precise delivery of chemotherapy to cancer cells, possibly improving effectiveness relative to toxicities.

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: 14-003957
NCT ID:
NCT01901653
Sponsor Protocol Number:
SCRX16-001

The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.

Rochester, MN

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The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.

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

Inclusion Criteria:

Healthy volunteers over the age of eighteen that have been recently dismissed from the Emergency Department at Mayo Clinic Hospital, Saint Marys Campus.
We will recruit a convenience sample of 100 patients from the Emergency Department who have completed their Emergency Department evaluation and treatment and are being discharged to home with non-painful conditions.

Exclusion Criteria:

We will exclude persons under the age of eighteen
Vulnerable populations (pregnant patients and prisoners)
Those with an allergy to any of the study agents
Those with acute pain
Those using antihypertensive or antiarrhythmic agents
Those with significant cardiopulmonary comorbidities (namely history of arrhythmia, coronary artery disease, hypertension, and heart failure)
Those with concomitant use of MAO-Inhibitors
Those with a diagnosis of angle closure glaucoma or BPH
Those with a history of cerebrovascular disease
As well as those with a history of previous nasal surgery or known nasal anatomic abnormalities.

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

Print study details

Site IRB:
- Rochester, Minnesota: 14-006312
NCT ID:
NCT02285634
Sponsor Protocol Number:
14-006312

Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility

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16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression

Rochester, MN, Austin, MN

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16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression

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 FLAME Study is a 16-week clinical trial to study treatment with lamotrigine or fluoxetine in bipolar I, II and bipolar schizoaffective depressed adults. The purpose of the trial is to have a better understanding of whether individuals with a particular gene type and other inherited biological markers will have a good response to fluoxetine or lamotrigine, or alternatively, would be more likely to have side effects to this medication.

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
Austin, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 13-003545
- Austin, Minnesota: 13-003545
NCT ID:
NCT02389712
Sponsor Protocol Number:
13-003545

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Search Results 281-290 of 10934

A Safety and Efficacy Study of Domvanalimab + Zimberelimab Combination Therapy in Participants With Advanced Upper Gastrointestinal Tract Malignancies

P1101 in Treating Patients With Myelofibrosis

Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population

Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System

Primary Hyperoxaluria Mutation Genotyping/Phenotyping

Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting

SC16LD6.5 in Recurrent Small Cell Lung Cancer

The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.

Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility

16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression

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