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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

3802 Study Matches

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Microvessel Ultrasound Imaging of Cutaneous Angiosarcoma (MVI Angiosarc)

A Study to Evaluate Skin Angiosarcoma Imaging with Ultrasound

Tiffany Sae-Kho
All
21 years and over
This study is NOT accepting healthy volunteers
2021-304725-H01-RST
21-005183
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Inclusion Criteria:

  • Patients over the age of 21.
  • New diagnosis of cutaneous angiosarcoma of the breast or scalp.
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Diagnosed with cutaneous angiosarcoma of the breast or scalp and scheduled for trimodality therapy.


Exclusion Criteria:

  • Individual under the age of 21.
  • Unwilling to consent to microvessel ultrasound imaging.

 

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Mayo Clinic — Rochester, MN

Physiological Regulation of Energy Intake - The FOOD-PRINT Study Identifying the Hormonal and Neural Footprints of the Visceroceptive, Homeostatic, and Hedonic Components of Food Intake Regulation in Humans (FOODPRINT)

Studying the Hedonic and Homeostatic Regulation of Food Intake using Functional MRI

Andres Acosta
All
21 years to 50 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306140-P01-RST
21-010514
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Inclusion Criteria:

  • BMI 18-25 kg/m^2.
  • Age > 21 and < 50 years.
  • Weight stable for 3 months prior to study entry.
  • For females: study days will be scheduled during the follicular phase of their menstrual cycle (i.e., the first 13 days (about 2 weeks) of the cycle).
  • Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures.
  • Ability to perform light to moderate physical activity.


Exclusion Criteria:

  • Any contraindication for MRI scanning.
  • Any history of childhood (> 95th percentile) or adult obesity (BMI >30 kg/m^2).
  • Claustrophobia.
  • High intensity training or physical activity.
  • Any contraindication for intragastric balloon insertion.
  • Any allergies to the study meals.
  • Any history of eating disorder.
  • Any substance abuse disorder (including alcohol and tobacco).
  • Any history of psychiatric disorders.
  • Any cardiovascular, endocrine, pulmonary, neurological, or gastrointestinal comorbidities.
  • Pregnancy or nursing.
  • Any history of bariatric surgery or endoscopic bariatric procedure.
  • Use of any medication or supplement that alters appetite.
  • Patient has a known history of any condition or factor judged by the investigator to prevent participation in the study or which might hinder study adherence.

Eligibility last updated 10/6/21. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

NOX66-004, A Dose Escalation and Dose Expansion Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma - CEP-2

A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma

Scott Okuno
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306447-P01-RST
21-011924
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Inclusion Criteria:


- Adult patients with a histologically confirmed diagnosis of metastatic or recurrent
soft tissue sarcoma

- Patients for whom treatment with doxorubicin is considered to be appropriate

- Left ventricular ejection fraction ≥ 50%

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Disease that is considered measurable according to RECIST v1.1.


Exclusion Criteria:


- Histologically or cytologically confirmed Kaposi's sarcoma, gastrointestinal stromal
tumor (GIST), extra-skeletal myxoid chondrosarcoma, epithelioid hemangioendothelioma,
and desmoid tumor

- Untreated metastases to the central nervous system

- Received previous treatment with anthracyclines and anthracenediones

- Previous radiation therapy to the mediastinal or pericardial area

- A known allergy to any of the treatment components

- Patient not willing to use suppositories

- Patients with a colostomy

- Patients who have had a colectomy (total or left hemicolectomy) with re-anastomosis

- Patients for whom administration of the suppositories are likely to cause pain (e.g.,
inflamed hemorrhoids, fissures, or lesions of the anus or rectum)

- Patients with fecal impaction, chronic idiopathic constipation, or chronic diarrhea or
alternating irritable bowel disease

- Patients with inflammatory bowel disease

- Previous treatment with an investigational agent or the non-approved use of a drug or
device within 4 weeks before study entry

- Uncontrolled diabetes mellitus

- Patients who require concomitant use of strong inhibitors or inducers of CYP3A4,
CYP2D6 or P- glycoprotein (P- gp)

Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Observational Feasibility Study of the Healthdot Wearable Monitoring Device in Bariatric Patients at Mayo Clinic (OHD)

Observational Study of Wearable Health Monitoring Device

Eric Vargas Valls
All
22 years to 60 years old
This study is NOT accepting healthy volunteers
2021-305321-H01-RST
21-007489
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Inclusion Criteria:
  

  • Age 22 to 60.
  • Patients being seen for upcoming planned weight-loss procedure (ESG, Balloon, Bariatric Surgery, Revision after Bariatric Surgery).
  • Commitment to wear device without removing for entire study period.
  • Located within a driving distance from Mayo Clinic in Rochester, Minnesota during study duration.
  • Reside in an area with 4G or 5G connectivity based on cellphone provider maps for T-Mobile or AT&T.
  • Subject clear of any dermatologic health diagnosis that may impede the ability of the device to adhere properly.


Exclusion Criteria:
   

  • Unable to give consent.
  • Unwillingness to utilize email address for device instructions, surveys, and reminders.
  • Lifestyle that would have the device exposed to excessive elements for a prolonged period of time outside the parameters of normal operation of the device.
  • Patient is expected/anticipated to fly (use an airplane) before study completion (before Day 10).
  • Subjects with a pacemaker or an implanted electronic device.
  • Subjects scheduled or likely to conduct MRI within the study period.
  • Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
  • Patients with severe systemic diseases.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

 

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Mayo Clinic — Rochester, MN

Ph.1, Open-Label, Dose Escalation & Expansion for Safety, Tolerability, PK, & Anti-Tumor Activity of STP707 Administered IV in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy.

Ph. 1, Evaluation of Safety, Tolerability, PK, Anti-tumor Activity of STP707 IV in Subjects With Solid Tumors

Zhaohui Jin
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2022-307781-P01-RST
22-003496
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Inclusion Criteria:


1. Subjects with histologically or cytologically confirmed advanced / metastatic or surgically unresectable solid tumors whose tumors are refractory to standard therapy.

2. Measurable disease per RECIST v 1.1 (primary or metastatic disease).

3. ECOG performance status 0
•1.

4. Life expectancy of at least 3 months.

5. Age ≥ 18 years.

6. Signed, written Institutional Review Board (IRB) approved informed consent

7. A negative serum pregnancy test (for nonsterile women of child-bearing potential).

8. Acceptable liver function:

- Bilirubin ≤ 1.5 times upper limit of normal;

- AST (SGOT), ALT (SGPT) ≤ 5 times upper limit of normal because of cancer or metastases to the liver.

9. Acceptable renal function, defined as:

o Serum creatinine ≤ 1.5 ULN or Creatinine Clearance ≥ 50 mL/minute.

10. Acceptable hematologic status:

- Hemoglobin ≥ 9 g/dL (a transfusion is allowed if Hemoglobin stays stable thereafter);

- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3;

- Platelet count ≥ 100,000 plt/mm^3 x 10^9/ L.

11. Urinalysis with no clinically significant abnormalities.

12. Acceptable coagulation status with partial thromboplastin time (PTT) and International Normalized Ratio (INR) ≤ 1.5 times upper limit of normal unless patient is on anti-coagulants and has stable PTT and PT that are within normal therapeutic range for disease under management.

13. Subject has adequate vitamin D level, as defined by serum total 25-Hydroxyvitamin D [25(OH)D] ≥ 20 to < 60 ng/mL. If subjects are below this threshold, they may receive
vitamin D supplementation se per clinic dosing guidelines and may still be enrolled provided they are started on vitamin D supplementation.

14. Completion of all previous treatments (including surgery, systemic chemotherapy, and radiotherapy) at least 3 weeks before screening.

15. For men and women of child-producing potential, the use of effective contraceptive methods during the study.


Exclusion Criteria:


1. Baseline Q-T corrected interval (QTc) interval of > 470 msec for all subjects calculated using Fridericia's formula.

2. New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/ peripheral artery bypass graft, congestive heart failure within the past 6 months.

3. Known active, uncontrolled infection with HIV or hepatitis B; subjects with hepatitis B allowed if on anti-viral therapy and have a viral load ≤ 500 IU; patients with a history of HIV must be on antiretroviral therapy for at least four weeks and have an HIV viral load ≤ 400 copies/mL, have CD4+ T cell counts ≥ 350 cells/uL and no history of AIDS-defining opportunistic infections within 3 months prior to treatment.

4. Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure, during the course of the study.

Note: Placement of a central venous access catheter(s) (e.g., port or similar) is not
considered a major surgical procedure.

5. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.

6. Pregnant or nursing women.

Note: Women of child-bearing potential and men must agree- to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

7. Participation in a clinical study involving administration of an investigational compound within the past 30 days prior to study entry.

8. Unwillingness or inability to comply with procedures required in this protocol.

9. Known allergy or hypersensitivity to the study drug(s) or one of the ingredients in the formulation (e.g., Trehalose dihydrate).

10. Existence of any surgical, medical or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism
or excretion of the drug.

Eligibility last updated 4/11/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op)

Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op): Prospective Assessment of HPV Associated Anogenital Pathology

Kathryn Van Abel
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-308294-H01-RST
22-005420
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Inclusion Criteria:

  • Female patients with diagnosed HPV(+)OPSCC seen at the Mayo Clinic, Rochester.
  • Age ≥ 18.
  • Female partners of Mayo Clinic patients with diagnosed HPV(+)OPSCC.
  • Patient has given permission to give his/her blood/saliva sample for research testing.
  • Ability to complete questionnaire(s) by themselves or with assistance. [LMM1] I.

Exclusion Criteria

  • HPV(-) OPSCC.
  • Unable to provide informed consent.
  • Unwilling to attend screening visit at Mayo. Clinic site, if indicated.
  • Unwilling/unable to complete surveys electronically.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/28/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Examining the Sociocultural Influences on Menstrual Health and Uterine Fibroids among Latinas and Black Women

Cultural Experiences of Black and Hispanic/Latina Women with Uterine Fibroids

Felicity Enders
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-308337-H01-RST
22-005762
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Inclusion Criteria:

  • Over the age of 18 years of age.
  • Biologically female.
  • Self-reported diagnosis of symptomatic uterine fibroids.
  • Self-identify as Black/African American and/or Hispanic/Latina.


Exclusion Criteria:

  • Under the age of 18.
  • Biologically male.
  • Not diagnosed with symptomatic uterine fibroids.
  • Does not self-identify as Black/African American and/or Hispanic/Latina.

Eligibility last updated 5/26/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Validation and feasibility of patient self-sampling of HPV for cervical cancer screening

Patient Self-sampling of HPV to Screen for Cervical Cancer

Kathy MacLaughlin
Female
25 years to 65 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-309081-P01-RST
22-008247
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Inclusion Criteria:

  • Females ≥ 25 and ≤ 60 years of age.
  • Appointment at Mayo Clinic Rochester in Gynecology Colposcopy Clinic or ICS (integrated community specialty) Colposcopy Clinic (will always include a speculum exam).
  • Appointment at Mayo Clinic Rochester in Gynecology Clinic for indication that will already include a speculum exam (e.g., cervical cancer screening or IUD insertion). 


Exclusion Criteria:
 

  • Excluded if pregnant.
  • Excluded if no cervix (history of total hysterectomy).
  • Excluded if moderate to heavy vaginal bleeding on the day of the visit.
  • Excluded if reason for visit in Gynecology Clinic is abnormal vaginal discharge.

Eligibility last updated 8/11/22. Questions regarding updates should be directed to the study team contact

Diagnostic Test
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Mayo Clinic — Rochester, MN

Molecular Diagnosis of Occult Peritoneal Metastasis from Gastric Cancer (MOPMEG)

Testing for Spread of Stomach Cancer to Abdominal Cavity

Travis Grotz
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-303616-H01-RST
21-001141
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Inclusion Criteria:

  • Adult patient, ≥ 18 years of age.
  • Undergoing diagnostic laparoscopy and peritoneal washings for staging of gastric adenocarcinoma per normal clinical indications.
  • Patients included will be those who are undergoing this procedure as part of their clinical work-up and will be identified by study staff and the clinical providers.
  • All patients will undergo staging imaging including high quality CT scan with contrast and/or PET CT or PER MRI imaging as standard of care. 
  • Patients will undergo diagnostic laparoscopy with traditional peritoneal cytology with H&E as well as IHC evaluation performed as standard clinical care. If a single patient undergoes multiple diagnostic laparoscopies with peritoneal cytology for clinical purposes excess fluid can be collected from each patient. 


Exclusion Criteria:

  • Any patient with insufficient excess peritoneal washing fluid will be excluded.

Eligibility last updated [date of initial abstraction or last Mod]. Questions regarding updates should be directed to the study team contact.

 

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Mayo Clinic — Rochester, MN

Optical Fusion Trans-Perineal Grid

Optical Fusion Trans-Perineal Grid

David Woodrum
Male
45 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-307730-H01-RST
22-003369
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Inclusion Criteria:

  • Scheduled for a MR guided biopsy or ablation.
  • Male, 45 years of age or older.
  • One, two, or three tumor suspicious regions identified on multiparametric MRI.
  • Tolerance for anesthesia/sedation.
  • Ability to give informed consent.


Exclusion Criteria:

  • Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
  • History of other primary non-skin malignancy within previous three years.
Device
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Mayo Clinic — Rochester, MN

Strategies and Treatments for Respiratory Infections &; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor

All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05605093
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Inclusion Criteria:

• Age ≥18 years.
• Informed consent for trial participation.
• Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection.
• Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non- NAT test [list of approved tests is in the PIM] collected within the prior 14 days.
• Onset of symptoms attributable to SARS-CoV2 infection occurred within 14 days before randomization.
• Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection.
Exclusion Criteria:

• The patient is expected to be discharged from the hospital within the next 24 hours.
• Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization.
• Use of a strong CYP3A inducer within 14 days prior to enrollment
• Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization.
• Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.
• Expected inability or unwillingness to participate in study procedures.
• In the opinion of the investigator, participation in a trial is not in the best interest of the patient.
• Allergy to investigational agent or vehicle
• Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622
• Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure.
• Known estimated glomerular filtration rate (eGRF) <30 mL/min/1.73m 2
• Continuous renal replacement therapy or chronic dialysis
• Current pregnancy
• Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent.
• Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent.
• Men who are unwilling to abstain from sexual intercourse with women of child- bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent.
• Inability to take investigational agent in tablet form by mouth.
Drug: Shionogi Protease Inhibitor (S-217622), Drug: placebo
COVID-19
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Hennepin Healthcare Research Institute (Site 027-001) — Minneapolis, Minnesota Hennepin ICC
M Health Fairview University of Minnesota Medical Center (Site 112-001) — Minneapolis, Minnesota Hennepin ICC - (strivehenn@insight-trials.org)
University of Minnesota — Minneapolis, Minnesota Rebecca Schoenecker - (sitereg@insight-trials.org)

Genomic Analysis of Glioma Tissue Samples

Genomic Analysis of Glioma Tissue Samples

Jann Sarkaria
All
18 years and over
This study is NOT accepting healthy volunteers
0000-116843-H01-RST
14-006254
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Inclusion Criteria:

  • Stereotactic imaging available corresponding to tissue location.
  • Age > 18 years.
  • MRI suggestive of glioma.
  • Planned craniotomy or biopsy.
  • Negative urine pregnancy test.
  • Informed written consent.
  • Signature for release of information.


Exclusion Criteria:

  • ​​​​​​​Not meeting criteria above.
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Mayo Clinic — Rochester, MN

Preclinical drug testing and assay development for lung adenocarcinoma characterized by the expression of ASCL1

Preclinical drug testing and assay development for lung adenocarcinoma characterized by the expression of ASCL1

Farhad Kosari
All
18 years and over
This study is NOT accepting healthy volunteers
0000-117314-H01-RST
15-001096
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Inclusion Criteria:

  • Patients with lung adenocarcinoma.


Exclusion Criteria:

  • Other subtypes of lung cancer.
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Mayo Clinic — Rochester, MN

Informatics Extractions of Ovarian and Uterine Cancer Patients' Cancer Diagnosis and Treatment-Related Phenotypes from Medical Records

Ovarian and Uterine Cancer Patients' Cancer Diagnosis and Treatment-Related Characteristics from Medical Records

Chen Wang
Female
18 years and over
This study is NOT accepting healthy volunteers
0000-117539-H01-RST
15-003408
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Inclusion Criteria:

  • Ovarian and uterine cancer patients seen in Mayo Clinic and with accessible electronic medical records.


Exclusion Criteria:

  • Patients with different diagnosed cancers other than ovarian and uterine cancer patients.
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STAT3 Expression in Patients with Diffused Intrinsic Pontine Glioma (DIPG)

STAT3 Expression in Patients with Diffused Intrinsic Pontine Glioma (DIPG)

David Daniels
All
up to 22 years old
This study is NOT accepting healthy volunteers
0000-119339-H01-RST
17-000031
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Inclusion Criteria:

  • The subject falls within the age range of 0-22 years old.
  • For non-DIPG (non-tumor tissue) subjects, waste tissue collected from surgery must not be tumor burdened.
  • For DIPG subjects, pathologies may also include pediatric high grade glioma along with midline high grade glioma also located in the pons and brain stem.


Exclusion Criteria:
 

  • Any participants older than 22 years of age.
Brain tumor, Cancer, Glioma
Diffuse intrinsic pontine glioma, Medical Oncology, Nervous system
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Mayo Clinic — Rochester, MN

A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA in Combination with an Intravitreal Anti-VEGF Agent in Subjects with Retinal Vein Occlusion (TOPAZ)

Study to Determine the Safety and Effectiveness of CLS-TA in Combination with an Intravitreal Anti-VEGF Agent in Subjects with Retinal Vein Occlusion

Raymond Iezzi
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-120656-P01-RST
18-001892
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Inclusion Criteria:

  • Has a clinical diagnosis of RVO in the study eye.
  • Has a CST of ≥ 300 µm in the study eye.
  • Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye.
  • Is naïve to local pharmacologic treatment for RVO in the study eye.


Exclusion Criteria:

  • Any active ocular disease or infection in the study eye other than RVO.
  • History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication.
  • Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study.
  • Any evidence of neovascularization in the study eye.

Drug, Drug therapy, Injection of drug into vitreous
Retinal vein occlusion
Thrombosis of retinal vein
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Mayo Clinic — Rochester, MN

High-Intermediate Risk Group in Endometrial Cancer Patients: Risk Factors for Recurrence

Risk Factors for Recurrence in Endometrial Cancer Patients

Andrea Mariani
Female
18 years and over
This study is NOT accepting healthy volunteers
0000-123092-H01-RST
20-000255
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Inclusion Criteria:

  • Patients who underwent primary surgery performed by an expert gynecologist oncologist at Mayo Clinic, Rochester, MN.
  • Research authorization.
  • Patients with endometrioid EC FIGO stage IB G1-2-3 and stage II G1-2-3 disease.
  • Patients who had confirmed negative lymph nodes with pelvic lymph node assessment.


Exclusion Criteria:

  • Presence of synchronous cancers, or previous neoadjuvant therapies.
  • Slides not available for pathologic review.
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Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Placebo-controlled Pilot Trial (MC211003)

Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy

Stephan Thome
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305219-P01-MAIJ
21-011969
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Registration

Inclusion Criteria:

  • Age ≥ 18 years.
  • English speaking.
  • Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy.
  • At least 4 out of 10 severity of neuropathy pain and/or tingling per appendix IV.
  • Stable for at least 7 days prior to registration [SJB1] [LCLM2] [GAM3] on medications for neuropathy, if any are being used.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
    • NOTE: If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Able to provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • No evidence of residual cancer.
  • Required Initial Laboratory Values: Following completion of chemotherapy, patients must have had a CBC and serum chemistries, including the following:
      • Platelet count > 100,000/mm^3;
      • Absolute neutrophil count (ANC) ≥ 1,000/mm^3;
      • Hemoglobin > 11 g/dL;
      • Serum transaminase [ALT or AST] ≤ 1.2 x upper limit of normal (ULN);
      • Alkaline phosphatase ≤ 1.2 x ULN;
      • Serum creatinine ≤ 1.2 x ULN.

Registration


Exclusion Criteria:

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Any medical condition that would prohibit use of a topical cream (skin infection or open wound in the area of the neuropathy).
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Pre-existing neuropathy prior to chemotherapy that would confuse the issue of CIPN.
  • Currently on chemotherapy or received chemotherapy treatment within the prior 3 months.
  • Use of other cannabis products within 30 days prior to registration.
  • History of allergy to cannabis products.

Crossover Re-Registration –

Inclusion Criteria:

  • Treatment cannot begin prior to registering to the crossover phase and will ideally begin ≤ 7 days after registration for the crossover phase.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

 

Behavioral, Drug, Other
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Mayo Clinic Health System — Mankato, MN

Phase 2 Clinical Trial of FIsetin to Treat CArpal Tunnel Syndrome (FITCATS) (FITCATS)

A Study of FIsetin to Treat CArpal Tunnel Syndrome

Peter Amadio
All
21 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-306106-H01-RST
21-010406
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Inclusion Criteria:

  • Males and females between age 21 and 80 years of age.
  • Symptoms of numbness or tingling for at least 4 weeks in at least two digits on one hand that include thumb, index, long, or radial border of ring finger.
  • Classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram.
  • A clinical diagnosis of carpal tunnel syndrome. Patients with bilateral CTS will have the more severe hand enrolled.
  • Able to complete English-language questionnaires and clinical evaluations.
  • Willingness to avoid pregnancy:
    • Female participants of childbearing potential must have a negative pregnancy test at screening (serum) and before the first dose on Day 1 (urine), before the third dose on Day 29 (urine), and 60 days after the final dose on day 60 (urine);
    • Sexually active female participants of childbearing potential must agree to take appropriate precautions to avoid pregnancy from screening until 30 days after the last dose of study drug (day 60).  Permitted methods in preventing pregnancy will be communicated to the participants and their compliance confirmed;
    • All female participants of childbearing potential will refrain from donating oocytes from screening-day 60 of the study;
    • Women without child bearing potential (i.e.., surgically sterile with hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible to participate without the above precautions.
  • Willing and able to comply with study procedures and requirements and attend all study visits as defined in this protocol.


Exclusion Criteria:

  • Unable or unwilling to give informed consent.
  • Pregnant or breast feeding.
  • Previous carpal tunnel release on the study hand.
  • History of steroid injection into carpal tunnel or surgery on the affected wrist within the past 6 months.
  • Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Escalation Study to Assess the Safety and Efficacy of SL-1002 Injectable for Treatment of Knee Pain Associated with Osteoarthritis

Osteoarthritis Injectable Treatment with SL-1002 to Assess the Safety and Efficacy

Ryan D'Souza
All
35 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2022-308040-P01-RST
22-004991
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Inclusion Criteria:


1. Male or female patients 35 years of age or older, with a Body Mass Index (BMI) of 18.0
to 40.0 kg/m2 and a total body weight of ≥50.0 kg for males and ≥45.5 kg for females.

2. Patients with chronic knee pain resulting from osteoarthritis for greater than 6
months prior to study Screening Visit 1 that interferes with functional activities
(e.g., ambulation, prolonged standing, etc.).

3. Patients currently experiencing continued pain despite receiving at least 3 months of
conservative treatments, inclusive of activity modification, home exercise, protective
weight bearing, and/or use of analgesics (e.g., acetaminophen or NSAIDs).

4. Patients with a baseline average pain score of ≥ 6 on an 11-point NRS scale as "usual
level of pain over the past 24 hours during weight-bearing activities" for the index
knee at Screening. The baseline average pain score is computed by finding the mean of
the daily NRS pain intensity scores reported during the 7-day run in period.

5. Patients with Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) radiologically
confirmed osteoarthritis (via x-ray/MRI/CT) within 6 months of study Screening Visit
1.

6. Patients with a baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) pain
subscale score ≥ 19 and ≤ 67 in the index knee.

7. Patients taking analgesics, inclusive of membrane stabilizers (e.g.,
Neurontin/gabapentin) and/or antidepressants (e.g., Cymbalta/duloxetine), for
osteoarthritis associated knee pain must be on a stable dose for at least 6 weeks
prior to study Screening Visit 1. Patients must agree to not alter the dose of
analgesics for the duration of the study without prior approval from the Investigator.

8. Female patients of childbearing potential who are sexually active with a male partner
must be willing to use one of the following acceptable contraceptive methods
throughout the study and for 30 days after the last study drug administration:

1. Intra-uterine contraceptive device placed at least 4 weeks prior to study drug
administration;

2. Male condom with intravaginally applied spermicide starting at least 21 days
prior to study drug administration;

3. Hormonal contraceptives starting at least 4 weeks prior to study drug
administration must agree to use the same hormonal contraceptive throughout the
study;

4. Sterile male partner (vasectomized since at least 6 months).

9. Female patients of non-childbearing potential as defined below:

1. Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable
cases a blood sample with simultaneous follicle stimulating hormone (FSH) and
estradiol levels consistent with menopause).

2. Pre-menopausal females with one of the following:

- Documented tubal ligation

- Documented hysteroscopic tubal occlusion procedure with follow-up
confirmation of bilateral tubal occlusion

- Hysterectomy

- Documented bilateral oophorectomy.

10. Patients must agree to see one treating physician (study Investigator) for knee pain
treatment for study duration.

11. Patients who have a positive response to a single genicular nerve block of the index
knee using 1.5
•3mL of lidocaine 2% solution administration to the genicular nerves
planned for treatment in each cohort (0.5mL per nerve). A positive response to the
qualifying lidocaine prognostic block is defined as ≥ 80% pain reduction within 60
minutes of receiving the lidocaine injections and ≥ 80% pain relief for a duration of
at least 60 minutes as documented on a standardized 6-hour pain log.

12. Patients must be able to understand and be able to complete all assessments associated
with the study outcome measures.

13. Patients must be able to understand the informed consent and be willing to provide
written informed consent. Patients must be able to comply with the requirements of the
protocol for the entire duration of the study.


Exclusion Criteria:


1. Patients with evidence of inflammatory arthritis (e.g., rheumatoid arthritis) or any
other systemic inflammatory condition (e.g., gout, pseudogout). 2. Current diagnosis of
fibromyalgia. 3. Patients with evidence of neuropathic pain affecting the index knee. 4.
Patients with prior or planned lower limb amputation. 5. Patients who have received an
intra-articular steroid injection into the index knee within 90 days of study Screening
Visit 1. 6. Patients who have received hyaluronic acid injection, Platelet Rich Plasma
(PRP), stem cell or arthroscopic debridement/lavage injection into the index knee within
180 days of study Screening Visit

- Patients who have received prior radiofrequency ablation or any other neurolytic
procedure of the genicular nerves of the index knee within 1 year of study Screening
Visit 1.

- Patients who have received prior partial, resurfacing, or total knee arthroplasty of
the index knee (residual hardware).

- Patients with clinically significant ligamentous laxity of the index knee as per
Investigator discretion.

- Patients with clinically significant valgus/varus deformities or evidence of pathology
(other than osteoarthritis of the knee) that materially affects gait or function of
the index knee or is the underlying cause of the knee pain and/or functional
limitations.

- Patients who are extremely thin and those with minimal subcutaneous tissue thickness
that could place the patient at risk of a chemical skin burn, at the discretion of the
Investigator.

- Patients with a pending or active compensation claim, litigation or disability
remuneration (possibility of secondary gain).

- Patients with chronic pain associated with significant psychosocial dysfunction.

- Patients with a Patient Health Questionnaire
•9 (PHQ-9) score of >10 (indicative of a
state of moderate depression).

- Patients with a systemic infection, active joint infection, or localized infection at
the planned needle entry sites (patient may be considered for inclusion once infection
is resolved).

- Patients with history of uncontrolled coagulopathy or unexplained or uncontrollable
bleeding that cannot be corrected, and patients with coagulopathy or who are being
treated with anticoagulants.

- Patients with moderate to severe hepatic impairment or moderate to severe renal
impairment.

- Identifiable anatomical variability that would materially alter the procedure as
described in the protocol.

- Patients currently prescribed opioid medications at a dose of >50 daily morphine
equivalents.

- Patients with uncontrolled immunosuppression (e.g., AIDs, cancer, diabetes) as per
Investigator discretion.

- Female patients who are pregnant or planning to become pregnant during the duration of
the study.

- Female patients who are breast-feeding.

- Patients who are unable or unwilling to comply with the requirements of the protocol.

- Patients taking any of the following concurrent medications/over-the counter products
(refer to Appendix 8 in full protocol for a list of applicable medications): c.
Probenecid or other organic anion transporter (OAT3) inhibitors. d. Inhibitors of
CYP2E1, such as disulfiram.

- Patients with known allergies or hypersensitivity to iodinated contrast medium and
gadolinium-based contrast medium. Known allergies or hypersensitivity to phenol and/or
lidocaine and/or their excipients.

- Patients with a documented history or evidence of alcohol or drug abuse within 1 year
of study screening visit 1.

- Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days of study Screening Visit 1,
administration of a biological product in the context of a clinical research study
within 90 days prior to the first dosing, or concomitant participation in an
investigational study involving no drug or device administration.

- Patients with clinically significant ECG abnormalities or vital sign abnormalities at
during study Screening Visit 1. Patients with ECG or vital sign abnormalities deemed
nonclinically significant or unlikely to result in clinical compromise by the
Principal Investigator may be considered for study inclusion.

- Patients with clinically significant laboratory results (as judged by the Principal
Investigator).

- Any condition, in the opinion of the Principal Investigator, that may pose a
significant risk to the patient, confound the results of the study or interfere
significantly with the patient's participation in the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/28/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

CBYL719C2202, EPIK-B4: A Phase II, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR During Treatment With Alpelisib (BYL719) in Combination With Fulvestrant in Participants With HR+, HER2-, Advanced Breast Cancer With a PIK3CA Mutation Following Progression on/After Endocrine-based Therapy (EPIK-B4)

Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant

Karthik Giridhar
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307161-P01-RST
22-001322
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Inclusion Criteria:

  • Participant has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) breast cancer by local laboratory.
  • Participant has a PIK3CA mutation(s) present in tumor prior to enrollment.
  • Participant has prior treatment with an endocrine-based treatment (i.e. letrozole, anastrozole, exemestane, fulvestrant or oral SERD) and may be:
    • relapsed with documented evidence of progression while on (neo) adjuvant endocrine- based therapy or within 12 months from completion of (neo)adjuvant endocrine-based therapy with no treatment for metastatic disease -relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine-based therapy and then subsequently progressed with documented evidence of progression while on or after only one line of endocrine-based therapy for metastatic disease;
    • newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine-based therapy.
      • Note: Participants with newly diagnosed endocrine-based treatment naïve advanced breast cancer will NOT be included in the study.
  • Participants may or may not have received prior CDK4/6i therapy. If prior CDK4/6i therapy was administered, it may have been in the adjuvant or metastatic setting.
  • If female, then the participant is postmenopausal.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Participant has adequate bone marrow and organ function


Exclusion Criteria:

  • Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease.
  • Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the Investigator’s assessment.
  • Participant had more than 1 line of prior treatment in the metastatic setting.
  • Participant has received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), any PI3K, mTOR or Akt inhibitor.
  • Participant has a known hypersensitivity to alpelisib, fulvestrant, dapagliflozin and metformin XR alone or in combination or to any of their excipients.
  • Participant has received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), any PI3K, Mammalian Target of Rapamycin (mTOR) or Protein Kinase B (Akt) inhibitor.
  • Participant has inflammatory breast cancer at screening.
  • Participant is concurrently receiving other anti-cancer therapy.
  • Participant has had major surgery within 14 days prior to study treatment start and/or has not recovered from major side effects.
  • Participant has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤ 1. Exception to this criterion: participant with any grade of alopecia are allowed to enter in the study.
  • Participant with Child Pugh score B or C.
  • Participant has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia).
  • Participant has a concurrent malignancy or malignancy within 3 years prior to randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
  • Participants with previously untreated central nervous system (CNS) involvement are ineligible for this study, unless they fulfill the following 3 criteria:
    • completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of study entry; and
    • CNS tumor is clinically stable at the time of screening; and
    • participant is not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases.
  • Participants with an established diagnosis of diabetes mellitus type I or participants with uncontrolled type II diabetes mellitus (FPG > 160 mg/dL and/or HbA1c > 8%) or type II diabetes mellitus requiring antihyperglycemic therapy.
  • Moderate to severe renal impairment (e.g., estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m^2 ).
  • Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) based on Investigator discretion.
  • Participant has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis.
  • Participant has uncontrolled hypertension, defined as a Systolic Blood Pressure (SBP) ≥ 160 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm/Hg, with or without antihypertensive medication. Initiation or adjustment of anti-hypertensive medication(s) is allowed prior to screening.
  • Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator’s judgment, contraindicate participant participation in the clinical study (e.g., chronic active hepatitis [testing not mandatory unless required by local regulations or requirements], severe hepatic impairment, etc.).
  • Participant has currently documented pneumonitis/interstitial lung disease (the chest Computerized Tomography (CT) scan performed before start of study treatment for the purpose of tumor assessment should be reviewed to confirm that there are no relevant pulmonary complications present).
  • Participant has clinically significant, uncontrolled heart disease and/or recent cardiac events including any of the following:
    • History of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 6 months prior to the start of study treatment;
    • History of documented congestive heart failure (New York Heart Association functional classification III-IV);
    • Left Ventricular Ejection Fraction (LVEF) < 50% at screening as determined by MUGA or ECHO;
    • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high grade atrioventricular (AV) block (e.g., bifascicular, Mobitz type II and third degree AV block without pacemaker in place);
    • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or Fridericia QT correction formula (QTcF) > 470 msec at screening.
  • Participant has a history of severe cutaneous reaction, such as Steven-Johnson Syndrome (SJS), erythema multiforme (EM), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS.
  • Participant has unresolved osteonecrosis of the jaw (ONJ).
  • Participant is currently receiving any of the following medications and cannot be discontinued at least 7 days prior to the start of study treatment:
    • Strong CYP3A4 inducers;
    • Inhibitors of BCRP.
  • Participant is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.
    • Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
  • Participant is a sexually active male not sterilized (at least 6 months prior to screening) or unwilling to use a condom during intercourse while taking study treatment, and for at least 1 year after stopping fulvestrant or for at least 1 week after stopping alpelisib. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm during the study and up to the time period specific above.
  • Participant participated in a prior investigational study within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.
  • Participant is not able to understand and to comply with study instructions and requirements, including oral administration of study treatment

Eligibility last updated 2/4/22. Questions regarding updates should be directed to the study team contact.

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A Phase 1b/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DISC-0974 in Participants With Myelofibrosis and Anemia

Study of DISC-0974 in Participants With Myelofibrosis and Anemia

Naseema Gangat
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2022-308216-P01-RST
22-005120
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Inclusion Criteria:

  • Age 18 years or older at the time of signing the informed consent (ICF). 
    • For Phase 1b: DIPSS score of 3 to 4 (intermediate-2 risk) or ≥ 5 (high-risk) primary MF, post-PV MF, and/or post-ET MF, as confirmed in the most recent local bone marrow biopsy report, according to WHO 2016 criteria.
    • For Phase 2: In addition to the criteria above, DIPSS score of 1 to 2 (intermediate-1 risk) may also be included.
  • Washout of at least 28 days prior to Screening of the following treatments: androgens, erythropoietin, cladribine, immunomodulators (lenalidomide, thalidomide), interferon alpha-2a. Systemic corticosteroids are permitted for non-hematological conditions if stable or decreasing dose for ≥ 28 days prior to Screening and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening. Screening can begin before the 28-day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.
  • Anemia: For Phase 1b: Hgb <10 g/dL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb <10 g/dL and receiving RBC transfusions periodically but not meeting criteria for TD participant as defined for the TD cohort (see Section 6.3). The baseline Hgb value for these participants is the lowest Hgb level during the 84 days prior to Screening, or RBC transfusion dependence, defined as an RBC transfusion frequency of ≥6 units PRBCs over the 84 days immediately prior to Screening There must not be any consecutive 42-day period without an RBC transfusion in the 84-day period, and the last transfusion must be within 28 days prior to Screening.
  • For Phase 2a: RBC transfusion dependence, defined as an RBC transfusion frequency of ≥ 6 units PRBCs over the 84 days immediately prior to Screening. There must not be any consecutive 42-day period without an RBC transfusion in the 84-day period, and the last transfusion must be within 28 days prior to Screening.
  • Stable dose of JAK inhibitor and/or hydroxyurea, or, if taking any other treatment for MF, stable for at least 28 days prior to Screening. If subject discontinues JAK inhibitor and/or hydroxyurea prior to Screening, a 28-day washout period is required.
  • Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.
  • Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening.
  • Transferrin saturation < 75% (local lab acceptable).
  • Liver iron concentration by MRI < 7 mg/g dry weight within 3 months of eligibility confirmation.
  • Serum ferritin ≥ 30 µg/L at Screening.
  • Platelet count ≥ 25,000/µL and < 1,000,000/µL; neutrophils ≥ 1,000/µL; and total white blood cell (WBC) count < 50,000/µL at Screening.
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.
  • Aspartate aminotransferase (AST) and alanine transaminase (ALT) < 3.0x upper limit of normal (ULN) at Screening.
  • Direct bilirubin < 2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis.
  • If male with female sexual partner(s) of childbearing potential, agrees he and partner(s) will use one of the following acceptable methods of birth control during the study and for 30 days after the last study drug dose:
    • abstinence;
    • stable hormonal contraceptive in conjunction with a barrier method (e.g., condom [male or female] or diaphragm);
    • intrauterine device, in place for at least 3 months;
    • surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.
  • If female of childbearing potential, defined as prior menarche, no hysterectomy, no bilateral oophorectomy, not postmenopausal [at least 12 months natural, spontaneous amenorrhea], must commit to one of the following methods of acceptable birth control during the study and for at least 8 weeks after the last study drug dose:
    • abstinence;
    • stable hormonal contraceptive in conjunction with a barrier method (e.g., condom [male or female] or diaphragm);
    • intrauterine device, in place for at least 3 months.
  • Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2) AND Baseline (Day 1).
  • Able to understand the study aims, procedures, and requirements, and provide written informed consent.
  • Able to comply with all study procedures.


Exclusion Criteria:

  • Hereditary hemochromatosis.
  • Hemoglobinopathy or intrinsic RBC defect associated with anemia.
  • Total splenectomy.
  • Hematopoietic cell transplant within the past 10 years.
  • Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding
  • Active immune-mediated hemolytic anemia.
  • Symptomatic bleeding, unrelated to surgery, in a critical area or organ and/or bleeding causing a decrease in Hgb of ≥ 2 g/dL or leading to transfusion of ≥ 2 units of RBCs in the 6 months prior to Screening.
  • Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery.
  • Malignancy with the past 3 years, other than primary MF, post-ET MF, or post-PV MF. The following history or concurrent conditions are allowed:
    • basal or squamous cell carcinoma;
    • carcinoma in situ of the cervix or the breast;
    • histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system).
  • A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior sponsor agreement.
  • Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 6 months prior to Screening.
  • Known allergic reaction to any study drug excipient, or anaphylaxis to any food or drug
  • A history of anti-drug antibody formation.
  • Inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and/or known to have left ventricular ejection fraction < 35%.
  • Active Hepatitis B or C, or human immunodeficiency virus (HIV) with detectable viral load.
  • Uncontrolled fungal, bacterial, or viral infection (ongoing signs/symptoms related to the infection, without improvement despite appropriate treatment).
  • Concurrent or planned treatment with momelotinib during the study period.
  • Iron chelation therapy in the 28 days prior to Screening.
  • Change in anticoagulant therapy regimen within 8 weeks prior to Screening.
  • Peripheral blood myeloblasts ≥ 10% of WBC differential at most recent evaluation prior to Screening.
  • Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening.
  • Pregnant or lactating.
  • Condition or concomitant medication that would confound the ability to interpret study data. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study.
  • Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices within 30 days prior to Screening.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/21/23. Questions regarding updates should be directed to the study team contact.

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AAML1831, A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations (AAML1831)

A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib to To Treat Newly-diagnosed AML with or without FLT3 Mutations

Mira Kohorst
All
up to 22 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-304791-P01-RST
21-005419
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Inclusion Criteria:


- All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part
A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens
must be done according to the Manual of Procedures

- Patients must be less than 22 years of age at the time of study enrollment

- Patient must be newly diagnosed with de novo AML according to the 2016 World Health
Organization (WHO) classification with or without extramedullary disease

- Patient must have 1 of the following:

- >= 20% bone marrow blasts (obtained within 14 days prior to enrollment)

- In cases where extensive fibrosis may result in a dry tap, blast count
can be obtained from touch imprints or estimated from an adequate bone
marrow core biopsy

- < 20% bone marrow blasts with one or more of the genetic abnormalities
associated with childhood/young adult AML as provided in the protocol
(sample obtained within 14 days prior to enrollment)

- A complete blood count (CBC) documenting the presence of at least 1,000/uL
(i.e., a white blood cell [WBC] count ≥ 10,000/uL with ≥ 10% blasts or a
WBC count of ≥ 5,000/uL with ≥ 20% blasts) circulating leukemic cells
(blasts) if a bone marrow aspirate or biopsy cannot be performed (performed
within 7 days prior to enrollment)

- ARM C: Patient must be >= 2 years of age at the time of Late Callback

- ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular
Oncology

- ARM C: Patient does not have any congenital long QT syndrome or congenital heart block

- ARM C: Females of reproductive potential must agree to use effective contraception
during treatment and for at least 6 months after the last dose of gilteritinib

- ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib
and for 2 months after the last dose of gilteritinib

- ARM C: Males of reproductive potential must agree to use effective contraception
during treatment and for at least 4 months after the last dose of gilteritinib

- ARM D: Patient must be ≥ 2 years of age at the time of Late Callback

- ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating
mutations as reported by Foundation Medicine

- ARM D: Females of reproductive potential must agree to use effective contraception
during treatment and for at least 6 months after the last dose of gilteritinib

- ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib
and for 2 months after the last dose of gilteritinib

- ARM D: Males of reproductive potential must agree to use effective contraception
during treatment and for at least 4 months after the last dose of gilteritinib

- NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who
transfer to Arm C or Arm D are not eligible

- NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment

- NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking

- NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to
diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental
retardation)

- NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would
prevent computer use or recognition of visual test stimuli

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met.


Exclusion Criteria:


- Fanconi anemia

- Shwachman Diamond syndrome

- Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21

- Telomere disorders

- Germline predispositions known, or suspected by the treating physician to increase
risk of toxicity with AML therapy

- Any concurrent malignancy

- Juvenile myelomonocytic leukemia (JMML)

- Philadelphia chromosome positive AML

- Mixed phenotype acute leukemia

- Acute promyelocytic leukemia

- Acute myeloid leukemia arising from myelodysplasia

- Therapy-related myeloid neoplasms

- Patients with persistent cardiac dysfunction prior to enrollment, defined as ejection
fraction (EF) < 50% (preferred method Biplane Simpson's EF) or if EF unavailable,
shortening fraction (SF) < 24%. *Note: if clinically safe and feasible, repeat
echocardiogram is strongly advised in order to confirm cardiac dysfunction following
clinical stabilization, particularly if occurring in the setting of sepsis or other
transient physiologic stressor. If the repeat echocardiogram demonstrates an EF >=
50%, the patient is eligible to enroll and may receive an anthracycline-containing
Induction regimen

- Administration of prior anti-cancer therapy except as outlined below:

- Hydroxyurea

- All-trans retinoic acid (ATRA)

- Corticosteroids (any route)

- Intrathecal therapy given at diagnosis

- In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be
avoided from the time of enrollment until it is determined whether the patient
will receive gilteritinib. Patients receiving gilteritinib will be required to
avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the
study treatment

- Female patients who are pregnant since fetal toxicities and teratogenic effects have
been noted for several of the study drugs. A pregnancy test is required for female
patients of childbearing potential

- Lactating females who plan to breastfeed their infants

- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation

- ARM D: Patient does not have any congenital long QT syndrome or congenital heart block

Eligibility last updated 6/20/22. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug, Procedure/Surgery
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A Phase 1b, Open Label, Global, Multicenter, Dose Determination, Randomized Dose Expansion Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of Iberdomide (CC-220) in Combination With R-CHOP-21 and CC-99282 in Combination With R-CHOP-21 for Subjects With Previously Untreated, Aggressive B-cell Lymphoma (CC-220-DLBCL-001)

Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma

Grzegorz Nowakowski
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305666-P01-RST
21-008752
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Inclusion Criteria:

  • Subject is ≥ 18 years of age the time of signing the informed consent form (ICF).
  • Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  • Subject is willing to undergo core needle or incisional/ excisional biopsy unless sufficient tissue is available from diagnostic tumor/ lymph node biopsy (from within 6 months prior to ICF signature) for translational research purposes.
  • Subject has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated, a-BCL according to 2016 WHO classification including:
    • DLBCL, NOS (including GCB and ABC types);
    • High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements;
    • Primary mediastinal (thymic) large B-cell lymphoma (PMBCL);
    • Primary cutaneous DLBCL-leg type;
    • EBV+ DLBCL, NOS;
    • Grade 3b FL.
  • Chemo- and immunotherapy-naïve FL transformed to a-BCL. Patient must not have received any previous therapy for the FL component.
  • Subject is considered an appropriate candidate (per investigator assessment) for induction therapy with 6 cycles of R-CHOP-21 or polatuzumab-R-CHP immunochemotherapy.
  • Subject has IPI score 0 to 5 in Part 1 and IPI 2 to 5 in Part 2. For the CELMoD and polatuzumab-R-CHP cohort, the subject must also have IPI score 0 to 5 in Part 2A and IPI 2 to 5 in Part 2B.
  • Subjects must have measurable disease defined by at least one FDG-avid lesion for FDG-avid subtype and one bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification (Cheson, 2014).
  • Subject has an ECOG performance status of 0, 1, or 2.
  • Subjects must have the following laboratory values:
    • ANC ≥ 1.5 × 10^9 /L or ≥ 1.0 × 10^9 /L in case of documented bone marrow involvement (> 50% or tumor cells), without growth factor support for 7 days (14 days if peg-G-CSF);
    • Hemoglobin (Hb) ≥ 8 g/dL;
    • Platelets (PLT) ≥ 75 × 10^9 /L or ≥ 50 × 10^9 /L in case of documented bone marrow involvement (> 50% or tumor cells), without transfusion for 7 days;
    • AST/SGOT and alanine aminotransferase )ALT)/ serum glutamate pyruvic transaminase (SGPT) ≤ 2.5 × ULN. In the case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤ 5.0 × ULN;
    • Serum total bilirubin ≤ 2.0 mg/dL (34 μmol/L) except in cases of Gilbert’s syndrome, then ≤ 5.0 mg/dL (86 μmol/L);
    • Subjects receiving polatuzumab vedotin must have serum total bilirubin ≤ 1.5 × ULN (26 μmol/L) (corresponding to mild degree as per National Cancer Institute Organ Dysfunction Working Group [NCI ODWG] criteria) except in cases of Gilbert’s syndrome, then ≤ 3.0 mg/dL (51 μmol/L);
    • Estimated serum creatinine clearance (CrCl) of ≥ 50 mL/min using the modification of diet in renal disease (MDRD) formula.
  • All subjects must:
    • Have an understanding that the study drug could have a potential teratogenic risk.
    • Agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment;
    • Agree not to share study medication with another person;
    • Agree to follow all requirements defined in the Pregnancy Prevention Program (see APPENDIX D) for CC-220 or CC-99282 Pregnancy Prevention Plan for Subjects in Clinical trials.
  • Females must agree to abstain from breastfeeding during study participation and for at least 28 days after last dose of CC-220 or CC-99282 discontinuation and according to the approved rituximab product/prescribing information.
  • Females of childbearing potential (FCBP^)* must:
    • Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact;
    • Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting IP, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of CC-220 or CC-99282 and for 12 months after the last dose of rituximab or polatuzumab vedotin, whichever is longer. Contraception requirements are detailed in APPENDIX D.
  • Male subjects must:
    • Practice true abstinence* (which must be reviewed on a monthly basis and source documented) or agree to use a condom (APPENDIX D) during sexual contact with a pregnant female or an FCBP while participating in the study, during dose interruptions and for at least 28 days after the last dose of CC-220, or CC-99282, 6 months after the last dose of polatuzumab vedotin, or 90 days for rituximab, whichever is longer, even if he has undergone a successful vasectomy.
    • Must agree to refrain from donating sperm while on study treatment, during dose interruptions, and for at least 28 days following last dose of CC-220, CC-99282 6 months after the last dose of polatuzumab vedotin, or 90 days following last dose for rituximab, whichever is longer.
    • ^A FCBP is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
    • *True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria:

  • Subject has any significant medical condition, active infection (including SARS-CoV-2 suspected or confirmed), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
    • A patient who is excluded for SARS-CoV-2 infection could be rescreened;
    • In the case of prior SARS-CoV-2 infection, symptoms must have completely resolved and based on investigator assessment in consultation with the clinical trial physician, there are no sequelae that would place the participant at a higher risk receiving investigational treatment;
    • Additionally, a patient who is currently in another interventional trial for COVID-19 may not participate in the clinical trial until the protocol-specific washout period is achieved;
    • Testing to exclude asymptomatic SARS-CoV-2 prior to enrollment should follow local standard practice.
  • Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Subject has any condition that confounds the ability to interpret data from the study.
  • Subject has any other subtype of lymphoma.
  • Subject has documented or suspected CNS involvement by lymphoma.
  • Subject has persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.
  • Subject has peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0).
  • Subjects with a history of progressive multifocal leukoencephalopathy.
  • Subject is on chronic systemic immunosuppressive therapy or corticosteroids (e.g., prednisone or equivalent not to exceed 10 mg per day within the last 14 days); stable use of inhaled or topical corticosteroids is allowed.
  • Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following:
    • Left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO);
    • Heart failure (New York Heart Association Class III or IV);
    • Clinically significant abnormal electrocardiogram (ECG) finding at screening;
    • Unstable angina or myocardial infarction ≤ 6 months prior to starting;
    • Persistent or uncontrolled ventricular arrhythmias or atrial fibrillation or cardiac conduction abnormalities not mitigated by a pacemaker.
  • Subject had major surgery ≤ 2 weeks prior to starting CC-220 or CC-99282; subject must have recovered from any clinically significant effects of recent surgery.
  • Subject has any condition causing inability to swallow tablets.
  • Subject has known seropositivity for or active viral infection with human immunodeficiency virus (HIV).
  • Subject has known chronic active hepatitis B (hepatitis B virus surface antigen [HBsAg] positive and/or hepatitis B core antibody [anti-HBc] positive with viral DNA positive) or C (positive serology requiring treatment and/or with evidence of liver damage) infection.
  • Subject has history of other malignancy, unless being free of the disease for ≥ 3 years; exceptions to the ≥ 3-year time limit include history of the following:
    • Localized nonmelanoma skin cancer;
    • Carcinoma in situ of the cervix;
    • Carcinoma in situ of the breast;
    • Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor Node Metastasis [TNM] staging system) or prostate cancer that has been treated with curative intent.
  •  Subject has current treatment with strong CYP3A4/5 modulators.
  • Subject has hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab or polatuzumab vedotin.
  • Subject has known hypersensitivity to any component of CHOP/CHP regimen.
  • Subject has known allergy to thalidomide, pomalidomide, or lenalidomide.
  • Subject received live attenuated vaccines or live COVID-19 vaccines within 30 days prior to initiation of study treatment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/13/23. Questions regarding updates should be directed to the study team contact.

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Gait Analysis in Aging and Neurological Disease

Analyzing Patient Gait in Aging and Neurological Disease

Farwa Ali
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308150-H01-RST
22-004877
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Inclusion Criteria:

  • Any adult over the age of 18.
  • Any patient able to walk unassisted with or without a gait aid.


Exclusion Criteria:
 

  • Individuals under the age of 18.
  • Individuals who are immobile (defined as unable to walk with or without a gait aid).

Eligibility last updated 6/5/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Investigating the Effect of Human Umbilical Cord MSCs Derived Exosome / Extracellular Vesicle on Endogenous Neural Cells Proliferation in Rats with Spinal Cord Injury

Umbilical Cord MSC's

Mohamad Bydon
Female
18 years to 35 years old
This study is NOT accepting healthy volunteers
2021-306602-H01-RST
21-012746
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Inclusion Criteria:

  • Healthy, full-term women (18-35 years old) who underwent elective cesarean section.
  • Free of Human Immunodeficiency Virus (HIV) types 1 & 2, Hepatitis A, B, and C, Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhea, and HTLV 1 & 2.
  • Able to give written informed consent prior to collection of the cord.


Exclusion Criteria:
 

  • On chronic, immunosuppressive transplant therapy or having a chronic, immuno-suppressive state, including use of systemic steroids/corticosteroids.
  • Takin anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
  • Ongoing infectious disease, including but not limited to tuberculosis, HIV, Hepatitis, and syphilis.
  • History of malignancy including melanoma except for localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.

Eligibility last updated 12/16/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation

Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation

Christi Patten
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-306821-H01-RST
22-000513
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Inclusion Criteria:

Index Participants will be eligible if they:

  • Are an ANAI person (based on self-reported race/ethnicity) and reside in Alaska.
  • Are aged ≥ 21 years (legal smoking age in Alaska).
  • Self-report smoking in the past 7 days, biochemically verified with breath expired air carbon monoxide (CO) > 4 ppm and saliva cotinine > 30 n/ml (positive Alere iScreen result).
  • Smoked > 3 cigarettes per day (cpd) over the past 3 months.
  • If other tobacco or nicotine product used, cigarettes are the main tobacco product used.
  • Are considering or willing to make a quit attempt.
  • Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad mini for the study duration.
  • Nominate one adult family member who will enroll.


Exclusion Criteria:

  • Used pharmacotherapy or a stop smoking program within the past 3 months.
  • Another person in the household is enrolled as the index participant.

Family Member Participants, regardless of smoking status or residence with the index participant, will be eligible if they:

  • Are ≥ 21 years old.
  • Are defined as family by the index participant.
  • Own or have access to a mobile phone or tablet with internet and text messaging capabilities or will be loaned an iPad mini for the study duration.
  • Both men and women and those from non-ANAI racial/ethnic groups.
  • Family members may only support one index participant to mitigate concern about lack of independence of household or other support networks, and potential for crosstreatment contamination, which could attenuate effects in the RCT.

Alaska Tribal Health System stakeholders:

  • Input from healthcare providers, cessation specialists, and THO leaders will be gathered to understand potential facilitators and barriers to adoption of the intervention within the ATHS. The ANTHC team will invite individuals to participate through phone and email communications.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

Other, Enrollment in smoking cessation program, Smoking cessation assistance, Smoking cessation education, Smoking cessation therapy
Cigarette smoker, Stop smoking services
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Mayo Clinic — Rochester, MN

Sleep Health, Symptoms, and Functional Performance in People With Inflammatory Bowel Disease (Sleep Health in IBD)

Sleep Health in Inflammatory Bowel Disease

Samantha Conley
All
18 years to 59 years old
This study is NOT accepting healthy volunteers
2022-308479-H01-RST
22-006109
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Inclusion Criteria:

  • Age ≥ 18 and < 60 years.
  • Diagnosed with IBD (Crohn’s disease, ulcerative colitis, or indeterminate colitis).
  • Living in the United States.  


Exclusion Criteria:
 

  • Patients with current ostomies or ileal pouches.
  • Currently in a medication trial for non-FDA approved medication for IBD.
  • Who are blind
  • With current cancer treatment.
  • Pregnant or breastfeeding.
  • Work night or rotating shifts.
  • Diagnosed with severe psychiatric (bipolar disorder, schizophrenia).
  • Neurological conditions affecting the non-dominant hand (due to actigraphy monitoring).
  • Those who do not read and write in English
  • Those without internet access or email address (due to use of internet surveys).
  • Note: We will delay data collection for at least four weeks for those who have had surgery, and 2 weeks for those who have traveled across a time zone or due to daylight savings.

Eligibility last updated 6/9/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease (INTERCEDE)

All
55 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03871075
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Inclusion Criteria:
All participants will have PAD. PAD will be defined as follows: first, an ankle-brachial index (ABI) < or = 0.90 at the baseline study visit is an inclusion criterion for PAD. Second, potential participants with an ABI >0.90 who have vascular laboratory evidence of PAD. Vascular laboratory evidence consists of objective evidence of PAD, including toe brachial index (TBI) < or = 0.70, Duplex measure showing 70% stenosis or greater, or ABI values < 0.90. Abnormal waveforms or pulse volume recordings alone from a non-invasive vascular laboratory test will not be sufficient for enrollment. Third, potential participants with an ABI >0.90 who have angiographic evidence of PAD consisting of a stenosis of 70% or greater in a lower extremity artery.
Exclusion Criteria:
1. Above- or below-knee amputation. 2. Critical limb ischemia or ABI < 0.30 in the setting of ischemic symptoms at rest or physical examination findings consistent with critical limb ischemia. Some potential participants with symptoms or signs of critical limb ischemia may be excluded at the principal investigator's discretion if the ABI is 0.30 or higher. 3. Wheelchair-bound. 4. Current foot ulcer on bottom of foot. 5. Walking is primarily limited by a symptom other than PAD. 6. Failure to successfully complete the study run-in. 7. Major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months. 8. Major medical illness including Parkinson's Disease, lung disease requiring oxygen, cancer requiring treatment in the previous two years, or life-threatening illness with a life expectancy of less than six months. Participants who only use oxygen at night will be potentially eligible. [NOTE: potential participants treated for cancer in the past two years may still qualify if they have had treatment for early stage cancer in the past two years and the prognosis is excellent. Potential participants treated for basal cell or squamous cell skin cancer will not be excluded.] 9. Already exercising at a level consistent with exercise intervention. Current or recent participation in exercise rehabilitation (within the past three months). 10. Recently diagnosed (within the past three months) with acute lower extremity deep venous thrombosis, pulmonary embolism, or severe heart failure (i.e. New York Heart Association (NYHA) Class III or IV). 11. Mini-Mental Status Examination (MMSE) score <23 or dementia. 12. Participation in or completion of a clinical trial in the previous three months. 13. Non-English speaking. 14. Increase in angina in the past month, angina at rest, or abnormal baseline treadmill stress test. Potential participants may become eligible after an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing (such as a stress test with imaging or a coronary angiogram) from a test performed with their own physician and if they do not have symptoms of unstable angina. The evidence of absent coronary ischemia, based on an imaging stress test or coronary angiogram, must have been performed within the previous year. 15. Ongoing infection of the toes, foot, or lower extremity. 16. Potential participants who started on cilostazol within the last three months. They may be evaluated for eligibility once three months have passed since beginning cilostazol. 17. Significant peripheral edema, defined as 3+ or greater edema severity, as determined by the principal investigator. 18. BMI >45 kg/M2 19. Significant visual impairment that interferes with walking. 20. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
Device: intermittent pneumatic compression, Behavioral: exercise, Device: Sham device, Behavioral: Health Education
Peripheral Artery Disease
peripheral arterial disease, Peripheral Artery Disease, PAD, exercise, Intermittent claudication
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University of Minnesota — Minneapolis, Minnesota Diane Treat-Jacobson, PhD - (treat001@umn.edu)

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria Patients Inadequately Controlled by H1-Antihistamines (CLOU064A2301)

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of Chronic Spontaneous Urticaria in Adults Inadequately Controlled by H1-antihistamines

Gerald Volcheck
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305571-P01-RST
21-008540
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Inclusion Criteria:


- Signed informed consent must be obtained prior to participation in the study.

- Male and female adult participants ≥18 years of age at the time of screening.

- CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined
by the investigator based on all available supporting documentation).

- Diagnosis of CSU inadequately controlled by second generation H1-antihistamines at the
time of randomization defined as:

- The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the
use of second generation H1-antihistamines during this time period

- UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-21) ≥
6 during the 7 days prior to randomization (Day 1)

- Documentation of hives within three months before randomization (either at screening
and/or at randomization; or documented in the participants medical history).

- Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration
of the study and adhere to the study protocol.

- Participants must not have had more than one missing UPDD entry (either morning or
evening) in the 7 days prior to randomization (Day 1).


Exclusion Criteria:


- Participants having a clearly defined predominant or sole trigger of their chronic
urticaria (CU) (chronic inducible urticaria (CINDU)) including urticaria factitia
(symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-,
aquagenic-, cholinergic-, or contact-urticaria

- Other diseases with symptoms of urticaria or angioedema, including but not limited to
urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis,
hereditary urticaria, or drug-induced urticaria

- Any other skin disease associated with chronic itching that might influence in the
investigator's opinion the study evaluations and results, e.g. atopic dermatitis,
bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis

- Evidence of clinically significant cardiovascular (such as but not limited to
myocardial infarction, unstable ischemic heart disease, New York heart association
(NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension
within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal,
hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or
immunodeficiency that, in the investigator's opinion, would compromise the safety of
the participant, interfere with the interpretation of the study results or otherwise
preclude participation or protocol adherence of the participant

- Significant bleeding risk or coagulation disorders

- History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal
anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring
hospitalization or blood transfusion)

- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100
mg/d or clopidogrel. The use of dual anti-platelet therapy (e.g. acetylsalicylic acid
+ clopidogrel) is prohibited.

- Requirement for anticoagulant medication (for example, warfarin or Novel Oral
Anti-Coagulants (NOAC))

- History or current hepatic disease including but not limited to acute or chronic
hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine
Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or
International Normalized Ratio (INR) of more than 1.5 at screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

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