Clinical Trials

A Study to Compare Intralipid Versus SMOFlipid in New Home Parenteral Nutrition (HPN) Patients

Rochester, MN

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A Study to Compare Intralipid Versus SMOFlipid in New Home Parenteral Nutrition (HPN) 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.

About this study

The primary aim of the study will be to assess impact on direct bilirubin with the use of Intralipid versus Smoflipid.

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:
17-001403
NCT ID:
NCT03773237
Sponsor Protocol Number:
17-001403

Mayo Clinic Traumatic Brain Injury Model System Center: The CONNECT Trial

Rochester, MN

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Mayo Clinic Traumatic Brain Injury Model System Center: The CONNECT 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

Mayo Clinic has been funded by the National Institute on Disability & Rehabilitation Research (NIDRR) as a Traumatic Brain Injury (TBI) Model System Center continuously since 1998. We have successfully competed for this funding because we consistently produce high quality research and because we provide comprehensive team-based rehabilitation services to people with TBI and their families over the continuum of care that is associated with superior outcomes.

Lack of access to specialized TBI care is the most common need identified by individuals after they are hospitalized for TBI. The upper Midwest has some of the highest populations of rural dwellers, the elderly, and Native Americans, all of whom have a high risk for TBI and are more likely to have limited access to rehabilitation services after acute care. Explosive advances in communication technology have brought tele-medicine to the forefront of health care. The CONNECT trial will test the effectiveness of using modern technologies - such as phone consultation and other telehealth communication systems - to deliver specialized brain rehabilitation resources remotely to patients and providers in the upper Midwest. The groups targeted by the CONNECT trial are:

Individuals recently hospitalized with TBI;
Their families;
Their local health care and other providers (primary care providers, psychologists, therapists, social service providers, job counselors).

The CONNECT trial is the first study of this scope - in 4 upper Midwest states (MN, IA, ND, and SD), 3 health systems (Mayo Clinic, Trinity Health in ND, Regional Health in SD), and 2 state Departments of Health (IA, MN) - using electronic technology to see if outcome can be improved by providing care with no face-to-face contact. The trial will study whether outcomes over three years are different in the group receiving this remotely provided model of care compared to a matched group that receives usual care in their communities.

The desired long term outcome of this study is to increase our capacity to provide care and to reduce barriers to accessing specialized TBI rehabilitation services faced by individuals with TBI and their families.

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:
12-008525
NCT ID:
NCT02088099
Sponsor Protocol Number:
12-008525

Investigation of Neurocognitive Measures of Sport-Related Injury

Rochester, MN

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Investigation of Neurocognitive Measures of Sport-Related Injury

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 overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.

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:
17-006025
NCT ID:
NCT03414242
Sponsor Protocol Number:
17-006025

Decreasing Agitation in Patients with Dementia Through the Use of Weighted Blankets

Rochester, MN

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Decreasing Agitation in Patients with Dementia Through the Use of Weighted Blankets

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 reduce behaviors and psychotic symptoms of dementia by using a weighted blanket as a non-pharmacological method to decrease agitation and distress in the elderly population.

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:
17-009951
NCT ID:
NCT03643991
Sponsor Protocol Number:
17-009951

Randomized, Double Blind, Placebo-controlled Phase 2 Study In Adults With Celiac Disease

Rochester, MN

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Randomized, Double Blind, Placebo-controlled Phase 2 Study In Adults With Celiac 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:
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 study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FB102 in adult participants with well controlled (on a strict GFD) CeD following an oral gluten challenge.

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:
25-013171
NCT ID:
NCT06982963
Sponsor Protocol Number:
FB102-301

Combination Of Serabelisib And Insulin Suppressing Diet In Subjects With Advanced Solid Tumors With PIK3CA Mutations

Rochester, MN

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Combination Of Serabelisib And Insulin Suppressing Diet In Subjects With Advanced Solid Tumors With PIK3CA Mutations

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 feasibility of optimizing the safety and tolerability of serabelisib when combined with an Insulin Suppressing Diet (ISD) with a goal of reducing side effects and enhancing anticancer activity.

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:
22-009034
NCT ID:
NCT05300048
Sponsor Protocol Number:
SER-ISD1-001

A Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of SPR720 As Compared With Placebo For The Treatment Of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease

Rochester, MN

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A Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of SPR720 As Compared With Placebo For The Treatment Of Participants With Mycobacterium Avium Complex (MAC) Pulmonary 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:
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 the study is to evaluate the microbiological response and clinical effectiveness of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). Additionally, to determine the safety and tolerability of SPR720 in a participants population with NTM- PD 3. Also, the pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in a participant population with NTM-PD.

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:
22-009850
NCT ID:
NCT05496374

Oral Epalrestat Therapy In Pediatric Subjects With PMM2-CDG

Rochester, MN

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Oral Epalrestat Therapy In Pediatric Subjects With PMM2-CDG

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 clinical and metabolic improvement of pediatric subjects with PMM2-CDG who are treated with epalrestat therapy compared to placebo, and to evaluate the safety, clinical improvement, and pharmacokinetics (PK) of epalrestat therapy in pediatric patients with PMM2-CDG compared to placebo when compared to baseline.

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:
22-005542
NCT ID:
NCT04925960

Treatment In Thoracic Aortic Aneurysm: Surgery Vs Surveillance

Rochester, MN

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Treatment In Thoracic Aortic Aneurysm: Surgery Vs Surveillance

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 ascending aorta conducts blood from the heart to the rest of the body. The ascending aorta can become enlarged, and the risk of tearing and rupturing becomes higher with larger aorta. When the ascending aorta tears or ruptures, the risk dying is high even if surgery is done as soon as possible. Traditionally, when the ascending aorta gets above 5.5 cm, surgery is recommended to replace the aorta. However, this threshold is based relatively weak evidence, and sometimes patients with smaller aorta can tear or rupture. On the other hand, surgery carries its own risk as well. Since there are risk of waiting or doing surgery, there is currently no great support for either approach for patients with a smaller aorta. In the TITAN SvS trial, patients with an ascending aorta between 5.0 to 5.5 cm is assigned by chance to the early surgery group, in which they will undergo replacement of aorta, or the surveillance group, in which they will be closely monitored. The chance of dying or suffer tearing or rupture of aorta between the two groups will be compared. The result of the trial will guide future practice for patients with enlarged ascending aorta.

This is a prospective, multi-centre randomized control trial that compares the all-cause mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those patients undergoing early elective ascending aortic surgery to those patients undergoing surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion criteria will be randomized to the early elective surgery group or the surveillance group. Recruitment will end when the desired sample size is reached, and the patients will be followed for a minimum 2-year period. The primary objective of the trial is to compare the composite outcome of the all-cause mortality and incidence of acute aortic events between surveillance and elective ascending aortic surgery for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up. The hypothesis is that the early surgery group will have a significantly lower all-cause mortality and incidence of acute aortic events at 2 years of follow up compare to the surveillance group. The result of this trial will provide evidence based guidance in the appropriate management of ascending aortic aneurysm based on the size criteria, and establish a large database for future investigations.

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

Print study details

Site IRB:
23-001854
NCT ID:
NCT03536312

A Trial To Assess The Efficacy And Safety Of TEV-53408 In Adults With Celiac Disease

Rochester, MN

See Details

A Trial To Assess The Efficacy And Safety Of TEV-53408 In Adults With Celiac 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:
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 primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.

The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease.

A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease.

The expected trial duration per participant is approximately 86 weeks.

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

Print study details

Site IRB:
25-000966
NCT ID:
NCT06807463

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Search Results 5631-5640 of 11953

A Study to Compare Intralipid Versus SMOFlipid in New Home Parenteral Nutrition (HPN) Patients

Mayo Clinic Traumatic Brain Injury Model System Center: The CONNECT Trial

Investigation of Neurocognitive Measures of Sport-Related Injury

Decreasing Agitation in Patients with Dementia Through the Use of Weighted Blankets

Randomized, Double Blind, Placebo-controlled Phase 2 Study In Adults With Celiac Disease

Combination Of Serabelisib And Insulin Suppressing Diet In Subjects With Advanced Solid Tumors With PIK3CA Mutations

A Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of SPR720 As Compared With Placebo For The Treatment Of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease

Oral Epalrestat Therapy In Pediatric Subjects With PMM2-CDG

Treatment In Thoracic Aortic Aneurysm: Surgery Vs Surveillance

A Trial To Assess The Efficacy And Safety Of TEV-53408 In Adults With Celiac Disease

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