Clinical Trials

The BEACON Study (Breast Cancer Outcomes With NKTR-102)

Jacksonville, FL, Rochester, MN

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The BEACON Study (Breast Cancer Outcomes With NKTR-102)

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 study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

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

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Site IRB:
12-001752
NCT ID:
NCT01492101
Sponsor Protocol Number:
11-PIR-11

MC240602

Jacksonville, FL

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MC240602

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

This pilot, two-arm, randomized study will assess the feasibility of measuring the efficacy of aspirin, compared with observation, for reducing PGE2 and a subset of factors in paired biopsies of endometrium tissue from post-menopausal women. Eligible participants will undergo two endometrial biopsies (i.e. baseline, week-6, or sooner if chosen through shared decision making) separated by 6 weeks (+/- 7 days).

At both timepoints, blood and urine will also be collected to investigate mechanisms of tissue changes. As secondary aims, additional biomarker testing of paired biospecimens (urine, blood, and tissue) will be conducted to assess the correlation of results with treatment group, and clinicopathologic status of the endometrium (i.e. PMB and endometrial thickening). Also, correlations between collected urine, blood, and tissue measures will be explored.

Based on prior knowledge that age and body composition play a role in mechanisms related to endometrial status, sub-group analyses of the primary and secondary endpoints will be conducted. Additional sub-groups in race and ethnicity will be explored as the data allow, due to known differences in endometrial cancer mortality.

Finally, qualitative interviews will be utilized to investigate feasibility of future clinical trials in the community.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Contact us for the latest status	View complete study & contact information

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Site IRB:
24-006515
NCT ID:
NCT07281547
Sponsor Protocol Number:
MC240602

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

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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

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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

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Site IRB:
21-007395

Study To Determine The Impact Of Advanced Magnetic Resonance Imaging (MRI) Using 18F-DOPA (A Chemical Tracer That Highlights Certain Cells During Imaging) During Planning For Proton Beam Radiation Therapy.

Scottsdale/Phoenix, AZ, Rochester, MN

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Study To Determine The Impact Of Advanced Magnetic Resonance Imaging (MRI) Using 18F-DOPA (A Chemical Tracer That Highlights Certain Cells During Imaging) During Planning For Proton Beam Radiation Therapy.

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 utilize a novel approach of combining advanced radiation delivery with proton beam therapy with advanced tumor visualization with 18F-DOPA PET and MRI imaging. We will study the effectiveness and safety of this technique delivering the entire treatment over 1-2 weeks.

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

Print study details

Site IRB:
17-007458
NCT ID:
NCT03778294
Sponsor Protocol Number:
MC1774

Cytomegalovirus (CMV) Vaccine In Orthotopic Liver Transplant Candidates (COLT)

Rochester, MN

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Cytomegalovirus (CMV) Vaccine In Orthotopic Liver Transplant Candidates (COLT)

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 safety of pre-Tx Triplex vaccination among Liver Transplant candidates, in conjunction with assessing the effect of pre-Tx Triplex vaccination on duration of Cytomegalovirus (CMV) AVT within the first 100 days post-Tx in D+R- LTxR, who will receive pre-emptive therapy as CMV prevention.

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:
23-006420
NCT ID:
NCT06075745

A Study To Assess The Safety And Tolerability Of Single And Multiple Doses Of KAN-101 In Celiac Disease Patients

Rochester, MN

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A Study To Assess The Safety And Tolerability Of Single And Multiple Doses Of KAN-101 In Celiac Disease Patients

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 assess the safety and tolerable of single and multiple doses of KAN-101 in patients with Celiac disease.

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:
19-012571
NCT ID:
NCT04248855
Sponsor Protocol Number:
KAN-101

Protonix Treatment Of Maintenance Of Healing In Pediatric Participants Aged 1-11 Years And 12-17 Years

Rochester, MN

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Protonix Treatment Of Maintenance Of Healing In Pediatric Participants Aged 1-11 Years And 12-17 Years

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 explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

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:
22-003619
NCT ID:
NCT04821310

Quanta Home Run Trial

Rochester, MN

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Quanta Home Run 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.
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 determine non-inferiority in safety and efficacy when Quanta SC+ is used in the self-care home environment compared to a hemodialysis facility.

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:
21-011623
NCT ID:
NCT04975880

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Search Results 391-400 of 11888

The BEACON Study (Breast Cancer Outcomes With NKTR-102)

MC240602

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

Study To Determine The Impact Of Advanced Magnetic Resonance Imaging (MRI) Using 18F-DOPA (A Chemical Tracer That Highlights Certain Cells During Imaging) During Planning For Proton Beam Radiation Therapy.

Cytomegalovirus (CMV) Vaccine In Orthotopic Liver Transplant Candidates (COLT)

A Study To Assess The Safety And Tolerability Of Single And Multiple Doses Of KAN-101 In Celiac Disease Patients

Protonix Treatment Of Maintenance Of Healing In Pediatric Participants Aged 1-11 Years And 12-17 Years

Quanta Home Run Trial

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