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A Study To Evaluate INO-3107 With Electroporation (EP) In Participants With HPV-6- And/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)

Scottsdale/Phoenix, AZ
- See Details
A Study To Evaluate INO-3107 With Electroporation (EP) In Participants With HPV-6- And/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)
- 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 purpose of this study is to evaluate the effectiveness, safety, tolerability and immunogenicity (ability to produce immune response) of INO-3107 in participants with HPV-6 and/or HPV-11 associated recurrent respiratory papillomatosis (RRP).

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:
20-006311

NCT ID:
NCT04398433

Sponsor Protocol Number:
RRP-001
A Study To Evaluate The Safety, Pharmacokinetics, And Preliminary Effectiveness Of Isatuximab In Patients Awaiting Kidney Transplantation

Rochester, MN
- See Details
A Study To Evaluate The Safety, Pharmacokinetics, And Preliminary Effectiveness Of Isatuximab In Patients Awaiting Kidney Transplantation
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  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 purpose of this study in Phase 1 is to characterize the safety and tolerability of isatuximab in kidney transplant candidates. The primary purpose of this study in Phase 2 is to evaluate the effectiveness of isatuximab in desensitization of patients awaiting kidney transplantation.

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:
20-001985

NCT ID:
NCT04294459

Sponsor Protocol Number:
TED16414

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

Diagnosing Epilepsy To EffeCT Change

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

See Details

Diagnosing Epilepsy To EffeCT Change

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

The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.

Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends.

All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

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

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Site IRB:
25-008938
NCT ID:
NCT07110337
Sponsor Protocol Number:
EM2401

A Study To Assess Effectiveness And Safety Of SER‑287 In Adults With Active Mild-to-Moderate Ulcerative Colitis

Rochester, MN
- See Details
A Study To Assess Effectiveness And Safety Of SER‑287 In Adults With Active Mild-to-Moderate Ulcerative Colitis
- 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 effectiveness and safety of SER-287 in adults with active mild-to-moderate ulcerative colitis.

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:
18-008864

NCT ID:
NCT03759041

Sponsor Protocol Number:
SERES-201

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

A Study Evaluating AMG 424 In Subjects With Multiple Myeloma

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

See Details

A Study Evaluating AMG 424 In Subjects With Multiple Myeloma

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

Prior clinical experience with CD38-targeting antibodies, including daratumumab, establish this molecule as an important therapeutic target in multiple myeloma. CD38 is a type II transmembrane glycoprotein with both ectoenzymatic and signal transductionfunctions. CD38 dimerization is required for its catalytic activity (Desphande et al, 2017).Dimeric CD38 possesses both ADP ribosyl cyclase and cADPR hydrolyase activities; the former generates cyclic ADP ribose (cADPR) from NAD+ and the latter generates ADPR. CD38-mediated cADPR generation enables calcium release from intracellular stores, leading to a variety of cell type-specific physiological outcomes (Schuber and und, 2004; Lee and Aarhus, 1991). A distinct mode of CD38-dependent signal transduction involved in the regulation of proliferation and survival requires interactions with other cell surface molecules (Deshpande et al, 2017; Deaglio et al, 2007; Konopleva et al, 1998). In B- lymphocytes for example, CD38-dependent signal transduction activity utilizes interactions with CD19 and CD31/PECAM-1, the latter of which is the sole identified ligand for CD38 (Deaglio et al, 2007). Importantly, AMG 424 binding to CD38 on target cells results in redirection of T cell mediated cytotoxicity but should not modulate CD38 enzymatic activity or CD38-dependent signal transduction, based on expected serum concentrations in our proposed dosing scheme and significanty reduced binding affinity compared to a monoclonal antibody that does inhibit CD38 activity (Deckert et al., 2014).For this first-in-human study, relapsed/refractory multiple myeloma has been chosen as the indication for clinical investigation of AMG 424 because of the nearly uniform high expression of CD38 on plasma cells observed at the protein level, using flow cytometry (Lin et al, 2004). Although low level CD38 expression is widespread in different tissue types, including hematopoietic cells, plasma cells express CD38 protein at signficantly higher levels than other cell types (Malavasi et al, 2008 and Section 3 of AMG 424 IB).

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:
19-001187
NCT ID:
NCT03445663
Sponsor Protocol Number:
20160445

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

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

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

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

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Search Results 5801-5810 of 11711

A Study To Evaluate INO-3107 With Electroporation (EP) In Participants With HPV-6- And/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)

A Study To Evaluate The Safety, Pharmacokinetics, And Preliminary Effectiveness Of Isatuximab In Patients Awaiting Kidney Transplantation

Diagnosing Epilepsy To EffeCT Change

A Study To Assess Effectiveness And Safety Of SER‑287 In Adults With Active Mild-to-Moderate Ulcerative Colitis

A Study Evaluating AMG 424 In Subjects With Multiple Myeloma

A Study To Establish An Eclipse Continence System Registry

A Study To Evaluate The Effectiveness And Safety Of BG00011 In Participants With Idiopathic Pulmonary Fibrosis (SPIRIT)

Safety And Efficacy Of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cells In Subjects With Relapsed Or Refractory BAFFR-expressing B-cell Hematologic Malignancies

Study Of Oral Treprostinil In Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)

Oral Treprostinil In Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)

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