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Radiation Therapy With Or Without Cetuximab In Treating Patients Who Have Undergone Surgery For Locally Advanced Head And Neck Cancer

Albert Lea, MN, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

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Radiation Therapy With Or Without Cetuximab In Treating Patients Who Have Undergone Surgery For Locally Advanced Head And Neck 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

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Albert Lea, MN	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Closed for enrollment
La Crosse, WI	Closed for enrollment
Mankato, MN	Closed for enrollment
Rochester, MN	Closed for enrollment

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Site IRB:
10-004511
NCT ID:
NCT00956007
Sponsor Protocol Number:
RTOG 0920

A Study Comparing Carotid Revascularization Endarterectomy Versus Stenting

Jacksonville, FL
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A Study Comparing Carotid Revascularization Endarterectomy Versus Stenting
- 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 relatively new procedure of stent-assisted carotid angioplasty to the traditional and accepted surgical approach of carotid endarterectomy for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).

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

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Site IRB:
82-01

NCT ID:
NCT00004732

Sponsor Protocol Number:
99–705

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

Phase 3 Study Of PDS0101 And Pembrolizumab In HPV16+ Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Phase 3 Study Of PDS0101 And Pembrolizumab In HPV16+ Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma

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

This is a global, multi-center, Phase 3 study that is randomized 2:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs. pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.

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
Rochester, MN	Closed for enrollment

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Site IRB:
25-002707
NCT ID:
NCT06790966
Sponsor Protocol Number:
VERSATILE-003

Hypofractionated Pre-Operative Radiation Therapy For Localized, Resectable Soft Tissue Sarcoma Of The Extremity Or Superficial Trunk

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Hypofractionated Pre-Operative Radiation Therapy For Localized, Resectable Soft Tissue Sarcoma Of The Extremity Or Superficial Trunk

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

We propose conducting a single arm, prospective study to evaluate the efficacy and safety of a preoperative hypofractionated course, 42.75 Gy in 15 fractions, for localized, extremity and superficial trunk soft tissue sarcomas. The biologic equivalent dose of this regimen is 45.20 Gy10, similar to 43.83 Gy10 associated with conventionally fractionated 50 Gy in 25 fractions, to determine acute wound complications rates, analyze local failure rate, disease-free survival, overall survival, patterns of relapse, late toxicities, quality of life/patient-reported outcomes, and cost differences. We hypothesize a 15 fraction hypofractionated radiation therapy course will be associated with equivalent short term toxicity rates and oncologic outcomes, as compared to historical standards.

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
Rochester, MN	Closed for enrollment

Print study details

Site IRB:
19-011871
NCT ID:
NCT04562480
Sponsor Protocol Number:
MC1973

A Study to Learn How Well Hearing Aid Customers Can Determine Ear Disease Risk Using a Questionnaire.

Jacksonville, FL
- See Details
A Study to Learn How Well Hearing Aid Customers Can Determine Ear Disease Risk Using a Questionnaire.
- 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

Current United States Food and Drug Administration (FDA) policies for adults seeking to purchase hearing aids balance two potentially conflicting healthcare objectives: (1) ensure public safety by detecting sinister ear disease prior to hearing aid purchase, and (2) make hearing aids and other hearing healthcare services more affordable and available. Two disease surveillance policies have evolved, reflecting this dichotomy. The FDA preferred surveillance method requires that consumers obtain a pre-hearing aid purchase medical evaluation. This is assumed to provide optimal disease detection - at the potential cost of decreased affordability and availability of hearing healthcare services. Although formally discouraged, consumers can waive the medical evaluation, thereby potentially increasing accessibility of hearing healthcare services - at the potential cost of missing sinister ear disease. The two FDA provisions are contradictory and there is little empirical evidence to support either as an effective public health policy or to inform alternative disease surveillance approaches.

When the medical waiver option is exercised, the burden of detecting ear disease falls upon the consumer and the non-physician hearing aid provider (e.g. audiologist or hearing aid specialist). The accuracy by which consumers or non-physician hearing aid providers assess ear disease risk is unknown. We propose to empirically evaluate how well non-physicians (in this stage, Mayo Clinic patients and audiologists) can evaluate their ear disease risk by developing and testing the performance of a consumer focused questionnaire (Consumer Ear Disease Risk Assessment or CEDRA) that is designed to be easy to complete, sensitive to ear disease risk factors, and result in a score that can be translated into a statistical estimate of ear disease likelihood. CEDRA will consist of questions that focus on recognition of ear disease symptoms. If CEDRA is found to accurately screen for ear disease, it might become useful to safely guide a consumer’s decision to use the medical waiver – making hearing aids more affordable and accessible when disease risk is low. If ear disease cannot be detected using this tool, the safety of the medical waiver option and direct to consumer hearing aid sales (such as over the internet) would have to be challenged.

This work will be accomplished as a sub-contract of a multi-site NIH R21-R33 award. Patients seeking services for hearing related problems in the Otorhinolaryngology (ORL)/Audiology Department at MCF will be asked to complete a prototype questionnaire. Questionnaire responses will be correlated with identified symptoms and neurotologic diagnosis recorded in the EMR. Through an iterative process, involving researchers at Mayo Clinic and Northwestern University, results will be used to create CEDRA for use in the R-33 phase of this work.

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

Print study details
Site IRB:
13-007964

Sponsor Protocol Number:
13-007964

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

FOG-001 In Locally Advanced Or Metastatic Solid Tumors

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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FOG-001 In Locally Advanced Or Metastatic Solid Tumors

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Contact us for the latest status	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
26-000175
NCT ID:
NCT05919264
Sponsor Protocol Number:
FOG-001-101

A Study Of MCLA-128 In Patients With Solid Tumors Harboring An NRG1 Fusion

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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A Study Of MCLA-128 In Patients With Solid Tumors Harboring An NRG1 Fusion

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, tolerability, movement (pharmcokinetics, "PK"), biological response (pharmacodynamics, "PD"), ability of the drug to provoke an immune response (immunogenicity) and anti-tumor activity of MCLA-128 in patients with solid tumors harboring an NRG1 fusion.

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
Rochester, MN	Closed for enrollment

Print study details

Site IRB:
19-007454
NCT ID:
NCT02912949
Sponsor Protocol Number:
MCLA-128-CL01

PTT-936, An Alpha Kinase 1 (ALPK1) Activator, Alone Or In Combination With Anti-PD-1/L1 In Patients With Locally Advanced Or Metastatic Solid Tumors

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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PTT-936, An Alpha Kinase 1 (ALPK1) Activator, Alone Or In Combination With Anti-PD-1/L1 In Patients With Locally Advanced Or Metastatic Solid Tumors

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The primary objective of this study is to evaluate the safety and tolerability of a pharmacologically active dose (PAD) range of PTT-936, which may include identification of the MTD, administered as a single agent in patients with advanced unresectable or metastatic solid tumors who have progressed after exhaustion of standard of care (SOC) or a SOC is not available.

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
Rochester, MN	Closed for enrollment

Print study details

Site IRB:
24-001268
Sponsor Protocol Number:
PTT-936-101

Phase 1 Study To Investigate TCRTs KRAS Mutation In Unresectable, Advanced, And/or Metastatic Solid Tumors

Jacksonville, FL
- See Details
Phase 1 Study To Investigate TCRTs KRAS Mutation In Unresectable, Advanced, And/or Metastatic Solid Tumors
- 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

Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, FL

Open for enrollment
View complete study & contact information

Print study details
Site IRB:
25-008738

NCT ID:
NCT06218914

Sponsor Protocol Number:
NT-112-301
Trial Of Sequential Treatment Of Multiple Myeloma With Antibody Therapy

Jacksonville, FL
- See Details
Trial Of Sequential Treatment Of Multiple Myeloma With Antibody 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 determine the overall response rate (ORR) of utilizing elotuzumab, pomalidomide and dexamethasone in patients with multiple myeloma resistant to daratumumab.

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

Print study details
Site IRB:
18-003574

NCT ID:
NCT03713294

Sponsor Protocol Number:
MC1884

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

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

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Search Results 1611-1620 of 2712

Radiation Therapy With Or Without Cetuximab In Treating Patients Who Have Undergone Surgery For Locally Advanced Head And Neck Cancer

A Study Comparing Carotid Revascularization Endarterectomy Versus Stenting

Phase 3 Study Of PDS0101 And Pembrolizumab In HPV16+ Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma

Hypofractionated Pre-Operative Radiation Therapy For Localized, Resectable Soft Tissue Sarcoma Of The Extremity Or Superficial Trunk

A Study to Learn How Well Hearing Aid Customers Can Determine Ear Disease Risk Using a Questionnaire.

FOG-001 In Locally Advanced Or Metastatic Solid Tumors

A Study Of MCLA-128 In Patients With Solid Tumors Harboring An NRG1 Fusion

PTT-936, An Alpha Kinase 1 (ALPK1) Activator, Alone Or In Combination With Anti-PD-1/L1 In Patients With Locally Advanced Or Metastatic Solid Tumors

Phase 1 Study To Investigate TCRTs KRAS Mutation In Unresectable, Advanced, And/or Metastatic Solid Tumors

Trial Of Sequential Treatment Of Multiple Myeloma With Antibody Therapy

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