Clinical Trials

A Study to Evaluate Dexamethasone Compared With Prednisone During Induction Therapy to Treat Patients with Newly-diagnosed, High Risk Acute Lymphoblastic Leukemia

Rochester, MN

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A Study to Evaluate Dexamethasone Compared With Prednisone During Induction Therapy to Treat Patients with Newly-diagnosed, High Risk Acute Lymphoblastic Leukemia

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

AALL0232 is a COG group-wide phase III study designed for NCI high risk patients with acute lymphoblastic leukemia (ALL) from 1-30 years of age. Although event free survival and overall survival continue to increase for children with high risk ALL, CNS disease has become an increasing cause of treatment failure. There is evidence that both dexamethasone and high dose methotrexate prevent CNS relapse. To specifically address the relative increase in CNS events this study will test safety and efficacy of these two therapeutic interventions. The study utilizes a 2 x 2 factorial design with an augmented intensity BFM backbone. Patients will be randomized upfront to receive high dose methotrexate (5 gm/m 2 ) versus Capizzi escalating methotrexate during Interim Maintenance I. A second randomization will compare dexamethasone 10 mg/m2 /day for 14 days versus prednisone 60 mg/m2 /day for 28 days during Induction. Based upon an increased rate of osteonecrosis (ON) observed in patients 10+ years of age randomized to receive dexamethasone during Induction, Amendment #5 restricts the Induction steroid randomization to patients 1-9 years of age, with older patients non-randomly assigned to prednisone during Induction therapy. Patients classified as rapid early responders (RER) will receive one Delayed Intensification course and those classified as slow early responders (SER) will receive two Delayed Intensification courses.

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

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Site IRB:
987-04
NCT ID:
NCT00075725
Sponsor Protocol Number:
AALL0232

Daratumumab in Cardiac HLA Desensitization Prior to Transplantation

Rochester, MN

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Daratumumab in Cardiac HLA Desensitization Prior to Transplantation

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 objectives of this study is to evaluate the efficacy of Daratumumab as an HLA desensitization strategy prior to cardiac transplantation in highly-sensitized patients.

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:
20-012885
NCT ID:
NCT05300451

Evaluation of NSR 7T Magnetic Resonance Imaging Hardware and Software

Rochester, MN

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Evaluation of NSR 7T Magnetic Resonance Imaging Hardware and Software

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 evaluate and develop new imaging techniques on the new MRI scanner.

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:
18-001345
Sponsor Protocol Number:
18-001345

Smoking Cessation Trial In Recurrent Acute Pancreatitis And Chronic Pancreatitis

Rochester, MN

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Smoking Cessation Trial In Recurrent Acute Pancreatitis And Chronic Pancreatitis

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 research is to assess the effectiveness of two treatment strategies for smoking cessation in patients with acute recurrent pancreatitis or chronic pancreatitis who smoke cigarettes. All participants will receive varenicline, a commonly used medication that helps people stop smoking, at its standard dose. For those who are unable to stop smoking after 6 weeks of treatment, they will be randomly selected to either 1) increase their dose of varenicline, 2) combine varenicline with bupropion (another medication that helps with smoking cessation) or continue on the standard dose of varenicline. At the end of 12 weeks of treatment, participants will be asked if they have stopped smoking with confirmation done by measuring carbon monoxide levels in their breath.

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:
25-004013
NCT ID:
NCT07171112

Sequencing for Families with Hereditary Disorders

Rochester, MN

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Sequencing for Families with Hereditary Disorders

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 project will examine the feasibility of offering whole genome sequencing (WGS), and developing a Rapid WGS protocol, for a fetus or neonate with multiple anomalies.

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

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Site IRB:
16-000562
Sponsor Protocol Number:
16-000562

Phase 1/2a Clinical Trial Of PR001 (LY3884961) In Patients With Parkinson's Disease With At Least One GBA1 Mutation (PROPEL)

Scottsdale/Phoenix, AZ, Rochester, MN

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Phase 1/2a Clinical Trial Of PR001 (LY3884961) In Patients With Parkinson's Disease With At Least One GBA1 Mutation (PROPEL)

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 safety of intracisternal LY3884961 administration in patients with moderate to severe Parkinson's disease with at least 1 pathogenic GBA1 mutation.

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
Rochester, MN	Open for enrollment	View complete study & contact information

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Site IRB:
25-002757
NCT ID:
NCT04127578
Sponsor Protocol Number:
J3Z-MC-OJAA

Eosinophilic Esophagitis Pilot Trial of Baked Milk Tolerance

Rochester, MN

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Eosinophilic Esophagitis Pilot Trial of Baked Milk Tolerance

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 assess how many patients with milk triggered EoE can tolerate re-introduction of baked milk, and to determine if there is a threshold amount of straight milk that is tolerated

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:
22-007941
NCT ID:
NCT05606705

A Study to Evaluate Obinutuzumab to Treat Immunosuppression-dependent or Immunosuppression/Treatment-resistant Focal Segmental Glomerulosclerosis

Rochester, MN

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A Study to Evaluate Obinutuzumab to Treat Immunosuppression-dependent or Immunosuppression/Treatment-resistant Focal Segmental Glomerulosclerosis

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 12 patients with immunosuppression-dependent or immunosuppression/treatment-resistant primary FSGS, or contraindication/patient refusal to take high dose corticosteroids, to test the effectiveness and safety of obinutuzumab in inducing complete or partial remission of proteinuria.

Patients with immunosuppression-dependent or immunosuppression/treatment-resistant primary FSGS or contraindication/patient refusal to take high dose corticosteroids, will receive obinutuzumab 1 gram on day 1 and 1 gram on day 15, given intravenously and then an identical course at 6 months.

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:
21-003887
NCT ID:
NCT04983888
Sponsor Protocol Number:
21-003887

Submandibular Gland Needle Core Biopsy and Skin Punch Biopsy as Tissue Biomarkers for the Diagnosis and Monitoring of Disease Progression of Parkinson’s Disease and REM Sleep Behavior Disorder

Scottsdale/Phoenix, AZ

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Submandibular Gland Needle Core Biopsy and Skin Punch Biopsy as Tissue Biomarkers for the Diagnosis and Monitoring of Disease Progression of Parkinson’s Disease and REM Sleep Behavior 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.

About this study

Determine 1) the magnitude of SMG and skin a-syn density change over time, 2) the

improvement in adequate tissue acquisition doing bilateral SMG biopsies, 3) any laterality differences between

SMG gland a-syn density, 4) correlate a-syn density and changes in density between SMG and skin biopsies

Specific Aim 1. Determine, with bilateral submandibular gland (SMG) biopsies in 30 clinically

diagnosed subjects with Parkinson’s disease (PD) and 20 clinically probable REM sleep behavior

disorder (RBD) subjects whether bilateral biopsies improve the rate of acquisition of adequate

glandular tissue, whether alpha-synuclein (a-syn) SMG pathology correlates with clinical severity

and/or disease duration, and whether there is a left-right difference in the density of a-syn pathology.

Specific Aim 2. Determine, with a second SMG biopsy in previously biopsied PD and RBD subjects,

whether a-syn pathology density increases, decreases, or remains the same after a 1.5-2 year time

interval and whether there is a correlation between a-syn SMG pathology and clinical and/or disease

progression.

Specific Aim 3. Determine whether a-syn pathology density in skin punch biopsies correlates

with clinical measures and increases, decreases, or remains the same after a 1.5-2 year time

interval, and whether the density and changes over time correlate with those found in SMG

biopsies.

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

Print study details

Site IRB:
21-007395

Visionary Study: Phase 3 Trial Of Sibeprenlimab In Immunoglobulin A Nephropathy (IgAN)

Scottsdale/Phoenix, AZ, Jacksonville, FL

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Visionary Study: Phase 3 Trial Of Sibeprenlimab In Immunoglobulin A Nephropathy (IgAN)

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 effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.

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	View complete study & contact information

Print study details

Site IRB:
22-002715
NCT ID:
NCT05248646
Sponsor Protocol Number:
417-201-00007

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Search Results 391-400 of 11578

A Study to Evaluate Dexamethasone Compared With Prednisone During Induction Therapy to Treat Patients with Newly-diagnosed, High Risk Acute Lymphoblastic Leukemia

Daratumumab in Cardiac HLA Desensitization Prior to Transplantation

Evaluation of NSR 7T Magnetic Resonance Imaging Hardware and Software

Smoking Cessation Trial In Recurrent Acute Pancreatitis And Chronic Pancreatitis

Sequencing for Families with Hereditary Disorders

Phase 1/2a Clinical Trial Of PR001 (LY3884961) In Patients With Parkinson's Disease With At Least One GBA1 Mutation (PROPEL)

Eosinophilic Esophagitis Pilot Trial of Baked Milk Tolerance

A Study to Evaluate Obinutuzumab to Treat Immunosuppression-dependent or Immunosuppression/Treatment-resistant Focal Segmental Glomerulosclerosis

Submandibular Gland Needle Core Biopsy and Skin Punch Biopsy as Tissue Biomarkers for the Diagnosis and Monitoring of Disease Progression of Parkinson’s Disease and REM Sleep Behavior Disorder

Visionary Study: Phase 3 Trial Of Sibeprenlimab In Immunoglobulin A Nephropathy (IgAN)

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