Clinical Trials

A Study of the Performance, Effectiveness and Safety of a Vibrating Capsule Device in Aiding Constipated Individuals

Rochester, MN

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A Study of the Performance, Effectiveness and Safety of a Vibrating Capsule Device in Aiding Constipated Individuals

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

This is a study intended to evaluate the effectiveness and safety of the vibrating capsule device versus a sham non-vibrating capsule on spontaneous bowel movement, to aid the relief of constipated individuals.

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: 15-000066
NCT ID:
NCT02030756
Sponsor Protocol Number:
15-000066

Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies

Rochester, MN

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Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies

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 is a Phase 2, uncontrolled, three-stage, ascending-dose-escalation study in subjects with one of three forms of TMA: atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenic purpura (TTP), or hematopoietic stem cell transplant (HSCT)-associated TMA. In the first stage, OMS721 will be administered to escalating dose cohorts of three subjects per cohort to identify the optimal dosing regimen. After enrollment and treatment of each cohort there will be a safety review to determine whether dose escalation should proceed. In the second stage, the dose selected in the first stage will be administered to expanded cohorts of 40 subjects per cohort with distinct etiologies (aHUS alone in one cohort and TTP or HSCT-TMA in the other cohort). Subjects completing the second stage may be eligible for continued treatment in the third stage if they have tolerated OMS721 treatment and derived clinical benefit. OMS721 is to be used in conjunction with standard of care treatments. Standard of care treatments are not to be delayed or withheld from subjects entering this study. These treatments should be initiated according to local standard of care. For example, plasma exchange should not be delayed or withheld from subjects suspected of having TTP while waiting for confirmatory ADAMTS13 laboratory results and potential initiation of OMS721 treatment. Subjects who have failed a treatment, e.g., subjects with plasma-therapy resistant aHUS, do not require continued treatment with the failed therapy.

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: 15-003047
NCT ID:
NCT02222545
Sponsor Protocol Number:
OMS721-TMA-001

A Study of LJPC-501 in Patients with Catecholamine-Resistant Hypotension

Rochester, MN

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A Study of LJPC-501 in Patients with Catecholamine-Resistant Hypotension

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 assess the effect of LJPC-501 (angiotensin II) on the mean arterial pressure in adult patients with catecholamine-resistant hypotension.

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: 15-001484
NCT ID:
NCT02338843
Sponsor Protocol Number:
LJ501-CRH01

Stereotactic Radiation Therapy for Pediatric Sarcomas

Rochester, MN

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Stereotactic Radiation Therapy for Pediatric Sarcomas

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 SBRT (stereotactic body radiation therapy) literature focuses on clinical outcomes in the adult population. However, SBRT (stereotactic body radiation therapy) has a particularly strong rationale for application in pediatrics given that high biologically effective doses have been shown to increase control in histologies, such as sarcoma, which are common in the pediatrics population (11,25). With stereotactic radiation therapy techniques, a reduction in normal tissue dose surrounding the target lesion of interest may also be accomplished resulting in lower toxicity. Given that pediatric patients with sarcomas, presenting with limited metastases in lung and bone, are still considered to be a curable population with aggressive local therapy, SBRT could have a significant impact on outcomes in oligometastatic patients who may be otherwise unresectable (25-28).

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: 14-003460
NCT ID:
NCT01763970
Sponsor Protocol Number:
14-003460

Study to Evaluate Imetelstat (JNJ-63935937) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Rochester, MN

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Study to Evaluate Imetelstat (JNJ-63935937) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

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 efficacy and safety of imetelstat in transfusion dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment.

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: 15-007603
NCT ID:
NCT02598661
Sponsor Protocol Number:
63935937MDS3001

Hypo-fractionated Proton Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

Scottsdale/Phoenix, AZ

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Hypo-fractionated Proton Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate 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:
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 effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

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

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Site IRB:
- Scottsdale/Phoenix, Arizona: 16-001524
NCT ID:
NCT01492972
Sponsor Protocol Number:
GU003-10

A Study Combining Tofacitinib with Gemcitabine for the Treatment of Pancreas Cancer in Patients who are Losing Weight

Rochester, MN

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A Study Combining Tofacitinib with Gemcitabine for the Treatment of Pancreas Cancer in Patients who are Losing Weight

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 test the safety, tolerability and possible benefit of a drug called tofacitinib in patients with metastatic pancreas cancer when given combined with a standard chemotherapy drug called gemcitabine.

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: 14-002298
Sponsor Protocol Number:
MC1443

EPVent 2- A Phase II Study of Mechanical Ventilation Directed by Transpulmonary Pressures

Rochester, MN

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EPVent 2- A Phase II Study of Mechanical Ventilation Directed by Transpulmonary Pressures

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 II multi-centered, randomized controlled trial of mechanical ventilation directed by esophageal pressure measurement will test the primary hypothesis that using a strategy of maintaining a minimal but positive transpulmonary pressure (PTP = airway pressure minus pleural pressure) throughout the ventilatory cycle will lead to an improvement in patient survival.

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: 15-004266
NCT ID:
NCT01681225
Sponsor Protocol Number:
EPVent2

Efficacy and Safety of Treatment With Alpelisib Plus Endocrine Therapy in Patients With HR+, HER2-negative aBC, With PIK3CA Mutations, Whose Disease Has Progressed on or After CDK 4/6 Treatment With an Aromatase Inhibitor (AI) or Fulvestrant

Scottsdale/Phoenix, AZ

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Efficacy and Safety of Treatment With Alpelisib Plus Endocrine Therapy in Patients With HR+, HER2-negative aBC, With PIK3CA Mutations, Whose Disease Has Progressed on or After CDK 4/6 Treatment With an Aromatase Inhibitor (AI) or Fulvestrant

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

Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6 treatment with an aromatase inhibitor (AI) or fulvestrant

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

Print study details

Site IRB:
- Scottsdale/Phoenix, Arizona: 17-008529
NCT ID:
NCT03056755
Sponsor Protocol Number:
CBYL719X2402

A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease

Rochester, MN

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A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney 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:
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 parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v. injection of iso-osmolar iodinated contrast material iodixanol (Visipaque™ Injection 320 mgI/mL), as compared with patients who received saline and underwent a non-enhanced CT (NECT) and duplex ultrasound (US) during their scheduled post-EVAR surveillance imaging.

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: 17-005360
NCT ID:
NCT03119662
Sponsor Protocol Number:
GE-012-106

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Search Results 2921-2930 of 10953

A Study of the Performance, Effectiveness and Safety of a Vibrating Capsule Device in Aiding Constipated Individuals

Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies

A Study of LJPC-501 in Patients with Catecholamine-Resistant Hypotension

Stereotactic Radiation Therapy for Pediatric Sarcomas

Study to Evaluate Imetelstat (JNJ-63935937) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Hypo-fractionated Proton Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

A Study Combining Tofacitinib with Gemcitabine for the Treatment of Pancreas Cancer in Patients who are Losing Weight

EPVent 2- A Phase II Study of Mechanical Ventilation Directed by Transpulmonary Pressures

Efficacy and Safety of Treatment With Alpelisib Plus Endocrine Therapy in Patients With HR+, HER2-negative aBC, With PIK3CA Mutations, Whose Disease Has Progressed on or After CDK 4/6 Treatment With an Aromatase Inhibitor (AI) or Fulvestrant

A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease

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