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DelIVery for Pulmonary Arterial Hypertension (PAH) Continued Support Study

Ongoing Support for Pump Refills in the DelIVery for Pulmonary Arterial Hypertension Study

Robert Frantz
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310099-P01-RST
22-012013
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Inclusion Criteria:

  • Patient is currently enrolled in the DelIVery for PAH Study (G100017).
  • The physician and patient determine that continued use of the PIVoT system is medically advisable.
  • Patient is willing to sign and date the Patient Informed Consent Form.


Exclusion Criteria:

  • < 18 years of age. 

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

Eligibility last updated 12/8/22. Questions regarding updates should be directed to the study team contact.

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A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants with Previously Untreated Metastatic or Unresectable Melanoma (RELATIVITY-127)

A Study of Subcutaneous Nivolumab + Relatlimab FDC in Previously Untreated Metastatic or Unresectable Melanoma

Svetomir Markovic
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-310120-P01-RST
22-012100
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Inclusion Criteria:
 

  • Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
  • Participants must have an Eastern Cooperative Oncology Group performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee on Cancer staging system (8th edition).
  • Participants must be treatment-naïve (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma).
    • Note that the following prior adjuvant or neoadjuvant melanoma therapies are allowed if all related adverse events have either returned to baseline or stabilized.
  • Anti-PD-1 or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) therapy with at least 6 months between the last dose and date of recurrence.
  • Interferon therapy with the last dose at least 6 weeks prior to randomization. 
  • BRAF- or MEK-inhibitor-containing adjuvant therapy regimens with at least 6 months between the last dose and date of recurrence.
  • Participants must have measurable disease by computed tomography or magnetic resonance imaging per Response Evaluation Criteria In Solid Tumors version 1 (RECIST v1.1).
  • Participants must have a documented LDH result during the screening period within 14 days prior to randomization to be used for randomization.
  • Participants with known BRAF V600 mutation status, or who consent to BRAF V600 mutation testing per local institutional standards during the Screening Period with the sample collected within 3 months prior to randomization. All BRAF statuses (ie, BRAF wild-type or BRAF 600 mutation positive) are eligible.
  • A formalin-fixed paraffin-embedded tissue block or a minimum of 15 unstained slides (20 preferred) of tumor tissue from core biopsy, punch biopsy, excisional biopsy, or surgical specimen obtained during screening or prior to randomization (within 3 months of enrollment with no intervening systemic anti-cancer treatment between time of acquisition and enrollment), with an associated pathology report, must be sent to the central laboratory prior to randomization. Fine needle aspirates or other cytology samples are not acceptable. Biopsies of bone lesions that do not have a soft tissue component are not acceptable. If an insufficient amount of tumor tissue from an unresectable or metastatic site is available prior to the start of the screening phase, participants must consent to allow the acquisition of additional tumor tissue during the screening period for biomarker testing. Assessment of tumor-cell PD-L1 expression by immunohistochemistry (IHC) also must be performed by central laboratory using pre-treatment tissue sample and results must be reported to IRT prior to randomization. PD-L1 status as determined using a 1% threshold will be a stratification criterion for randomization. Participants with indeterminate or unevaluable PD-L1 results will not be permitted to randomize to a treatment arm.
  • Participant Re-enrollment: This study permits the re-enrollment of a participant that has discontinued the study as a pre-treatment failure (ie, participant has not been randomized). If re-enrolled, the participant must re-consent.


Exclusion Criteria:

  • Participants must not have active brain metastases or leptomeningeal metastases. Participants with brain metastases are eligible if these are:
    • Asymptomatic;
    • Have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the central nervous system [CNS] treatment); and
    • There is no MRI evidence of progression for at least 4 weeks after CNS directed therapy is complete and within 28 days prior to first dose of study treatment administration;
    • In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization;
    • Participants with brain disease treated with whole brain radiation are not eligible.
  • Participants must not have ocular melanoma.
  • Participants must not have an active, known, or suspected autoimmune disease. Participants may enroll with the following conditions:
    • Type 1 diabetes mellitus;
    • Hypothyroidism only requiring hormone replacement therapy;
    • Skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment;
    • Conditions not expected to recur in the absence of an external trigger.
  • Participants must not have a history of myocarditis, regardless of etiology.
  • Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Participants must not have a concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease). Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible.
  • Participant must not have had prior treatment with an anti-PD-1 (except if given as adjuvant or neoadjuvant therapy for melanoma), anti- PD-L1, anti-programmed death-ligand 2, antiCTLA-4 antibody (except if given as adjuvant or neoadjuvant therapy for melanoma), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (except for interferon given as adjuvant or neoadjuvant therapy for melanoma) within 6 months prior to start of study treatment.
  • Participant must not have had prior treatment with relatlimab or any other lymphocyte activation gene 3-targeted agents.
  • Prior radiation therapy within 2 weeks prior to first study treatment. Participants must have recovered (i.e., Grade ≤ 1 or at baseline) from radiation-related toxicities prior to first study treatment.
  • Participants who are pregnant or breastfeeding.
  • Troponin T (TnT) or I (TnI) > 2 × institutional upper limit of normal (ULN). Participants with TnT or TnI levels between > 1 × to 2 × ULN will be permitted if repeat levels within 24 hours are ≤ 1 × ULN. If TnT or TnI levels are between > 1 × to 2 × ULN within 24 hours, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2 × ULN, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator. Notification of the decision to enroll the participant has to be made by the BMS Medical Monitor or designee.
  • Left ventricular ejection fraction (LVEF) assessment with documented LVEF < 50% by either transthoracic echocardiogram (TTE) or multigated acquisition scan (TTE preferred test) within 6 months prior to start of study treatment.

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

Eligibility last updated 11/16/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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Reishi Mushroom Extract for fatigue and/or arthralgias in patients with breast cancer on aromatase inhibitors: a randomized phase II MNCCTN trial (MC221002)

Reishi Mushroom for Fatigue And/or Arthralgias for Patients With Breast Cancer on Aromatase Inhibitors

Stacy D'Andre
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-310126-P01-RST
23-005266
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Inclusion Criteria

  • Age ≥ 18 years.
  • History of breast Cancer, ER+, Her 2 positive or negative.
  • Fatigue ≥ 4/10.
  • Currently taking any aromatase inhibitor in the curative setting and planning to be on such for at least 8 weeks after registration. (Patients on concurrent ovarian suppression (such as with leuprolide acetate, goserelin) are allowed).
  • Prior treatment: last chemotherapy ≥ 90 days prior to randomization (if treated with chemotherapy). 
  • On a stable dose of pain medications if pain medications are being regularly used. (i.e., no change in dosage in the past 30 days).
  • If on supplements, must be on stable dose with no plan to change; not on or planning any acupuncture or other specific supportive modalities for fatigue or AI arthralgias.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • Required Initial laboratory values obtained ≤ 30 days prior to randomization, including the following:
    • White blood cell count (WBC) ≥ 3,000/mm^3;
    • Hemoglobin ≥ 10 g/dL;
    • Platelet count ≥ 100,000/mm^3;
    • Total bilirubin ≤ 1.5 x ULN;
    • Alanine aminotransferase (ALT) or Aspartate transaminase (AST) ≤ 1.2 x ULN;
    • PT/aPTT ≤ 1.5 x ULN.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
  • Provide written informed consent.
  • Ability to complete questionnaires.
  • Willing to return to enrolling institution during the Active Monitoring Phase of the study.


Exclusion Criteria:

  • Other known uncontrolled medical conditions causing fatigue such as untreated thyroid disease, depression, fibromyalgia, chronic fatigue syndrome, infection, autoimmune disease, or active/untreated hepatitis.
  • Allergy to mushrooms.
  • On anticoagulation medication or aspirin or having a known bleeding disorder.
  • On any specific medication for fatigue (e.g., methylphenidate).
  • Metastatic cancer diagnosis (history of nodal metastases is allowed).
  • Chronic steroid use, unless on physiologic replacement doses.
  • Current use of any medical mushrooms.
  • On medications for diabetes.
  • History of symptomatic hypotension.
  • Taking CYP3A4, CYP2D6 or CYP2E1 substrates.
  • Taking CDK4/6 inhibitors or olaparib.
  • Any of the following because this study involves an agent that has unknown genotoxic, mutagenic and teratogenic effects:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception.

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

Eligibility last updated 6/30/23. Questions regarding updates should be directed to the study team contact.

Behavioral, Dietary Supplement, Drug, Other
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Safety and Feasibility of Autologous Induced Pluripotent Stem Cells of Cardiac Lineage in Subjects With Congenital Heart Disease

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage Delivered Into Heart Muscle for Congenital Heart Disease

Rebecca Ameduri
All
18 years to 40 years old
Phase 1
This study is NOT accepting healthy volunteers
2022-310135-H01-RST
22-012171
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Inclusion Criteria:


- Age 18 to 40 years old.

- Subject must be able to understand and provide informed consent.

- Univentricular congenital heart disease.

- End-stage systolic heart failure, defined as Class IV according to New York Heart Association (NYHA) with abnormal visually estimated ejection fraction below 40%.

- Prognosis of 1 to 1.5 years survival at time of skin biopsy.

- The patient falls into one of the following categories:

- Currently listed for heart transplantation at an accredited program in the US but has an expected waiting time for a suitable organ that is likely longer than anticipated life-expectancy;

- Has been denied access to a heart transplantation at an accredited US institution;

- Is currently on or planning to be on mechanical support as destination therapy.

- All guideline directed therapy available to the subject has been maximized, for a minimum of 3 months prior to enrollment.

- Adequate social support system that facilitates subject participation in all study required tests and procedures and supports the subject's ability to comply with long-term study requirements.


Exclusion Criteria:

- No available autologous iPSC-CL as defined by the manufacturer's release criteria.  (This applies to Part II of the study and applies to the treatment arm only).

- History of symptomatic episodes of cardiac arrythmia requiring cardiac defibrillation or escalation of medications.

- Heart failure with preserved ejection fraction.

- Heart failure due to co-morbid conditions (e.g., amyloidosis, valvular heart disease, refractory anemia).

- QTc greater than 500 ms.

- Stage III or higher chronic kidney disease.

- Decompensated liver cirrhosis.

- History of coronary artery disease.

- Uncontrolled diabetes mellitus.

- Any history of cancer.

- Contraindication for use of amiodarone for up to 3 months (treatment arm only).

- Contraindication for insertion of Insertable Cardiac Monitor.

- Contraindication for placement of LifeVest cardioverter defibrillator.

- Positive serology testing for HIV, Hepatitis B, Hepatitis C or Syphilis.

- Obesity with BMI greater than 30.

- Current alcohol or drug abuse precluding heart transplantation.

- Active infection requiring ongoing treatment.

- Contraindication to anesthesia.

- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality of the data
obtained from the study.

- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.

- History of non-compliance.

- Inability to be accompanied around the clock for any part of the first 3 weeks post product administration.

- Uncontrolled depression.

- Denied heart transplant due to social determinants.

- Current participation in another cardiac interventional clinical trial that could confound the results of this study.

- Previous heart transplant.

Eligibility last updated 7/19/23. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine
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The effects of acute and chronic exercise on the immune phenotype of indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia patients

The Effects of Acute and Chronic Exercise on the Immune Phenotype of Chronic Lymphocytic Leukemia Patients

Neil Kay
All
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-310156-P01-RST
22-012246
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Inclusion Criteria:

  • Individuals who are English speaking.
  • Individuals between the ages of 18-80.
  • Individuals with histologically confirmed diagnosis of indolent non-Hodgkin lymphoma (NHL) will be required to participate in Aim 2 (CLL/SLL only), aim 3 and 4 (indolent NHL) and aim 5 (indolent NHL) of this study. z
  • Individuals will not be excluded based on baseline exercise.


Exclusion Criteria:

  • Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular or pulmonary disease (e.g., heart disease, coronary artery disease, COPD, asthma, etc.) an  orthopedic or musculoskeletal limitation which would limit ability to exercise or are a current or former smoker.
  • Indolent NHL individuals receiving treatment must have least 8 weeks of planned treatment remaining and those not currently receiving treatment must be at least 6 months post and have no planned treatments during the 12-week intervention period to be eligible.
  • Individuals will be excluded if they have uncontrolled hypertension, cardiac illness, or are not approved by their oncologist to participate.

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

Eligibility last updated 10/3/2023. Questions regarding updates should be directed to the study team contact.

Procedure/Surgery, Behavioral, Other
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Mayo Clinic — Rochester, MN

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab in Adult Subjects With H-1 Antihistamine Refractory Chronic Spontaneous Urticaria (MAVERICK)

A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria

Gerald Volcheck
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-310167-P01-RST
22-012682
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Key

Inclusion Criteria:


1. Subject is able to understand the information on the study, has the capacity to
consent, and has provided written informed consent.

2. Male and female subjects ≥ 18 years of age at the time of screening.

3. CSU diagnosis for ≥ 6 months.

4. Diagnosis of moderate-severe CSU refractory to H1-antihistamine (H1-AH) at a minimum
of the licensed dose at the licensed frequency at the time of randomization as defined
by the following: presence of hives and itch for ≥6 consecutive weeks prior to
Screening Visit 1; UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥8 during
the 7 days prior to randomization.

5. Subjects that are omalizumab-naïve or omalizumab-exposed.

6. Subjects must be on stable dose of H1-AH, between 1x and 4x of the licensed dose and
at the licensed frequency, for treatment of CSU for at least 1 week prior to screening
and willing to remain on a stable dose throughout the study.

7. Able and compliant with completing a daily symptom eDiary for the duration of the
study and adherent to the study visit schedules.

Key
Exclusion Criteria:


1. History of hypersensitivity to the study drugs or their excipients or to drugs of
similar chemical classes (i.e., murine, chimeric or human antibodies).

2. Current use of biologics for any indication.

3. Demonstrated lack of primary response to treatment with a biologic therapy (e.g.,
omalizumab) for the treatment of CSU.

4. Use of any of the following treatments within 4 weeks prior to the baseline visit or
any condition that in the opinion of the Investigator is likely to require such
treatment(s) during the first 4 weeks of study treatment: (i) immunosuppressive or
immunomodulatory drugs, including but not limited to systemic calcineurin inhibitors
(e.g., cyclosporin, tacrolimus), mTOR inhibitors (e.g., sirolimus, everolimus),
anti-metabolites (e.g., azathioprine, methotrexate, 6-mercaptopurine, leflunomide,
mycophenolate mofetil), alkylating agents (e.g., cyclophosphamide), TNF inhibitors
(e.g., infliximab, adalimumab), and eosinophil-depleting drugs (e.g., benralizumab,
pramipexole); (ii) routine (daily or every other day during 5 or more consecutive
days) doses of systemic hydroxychloroquine; (iii) intravenous immunoglobulin (IVIG);
(iv) plasmapheresis.

5. Use of oral Janus kinase (JAK) inhibitors within 8 weeks of the baseline visit.

6. Use of any of the following treatments within 3 weeks prior to the baseline visit: (i)
H2 antihistamines (H2-AH); (ii) routine (daily or every other day during 5 or more
consecutive days) doses of systemic corticosteroids; (iii) regular (daily or every
other day) doxepin (oral); (iv) leukotriene receptor antagonists (LTRA) (e.g.,
montelukast, zafirlukast).

7. H1-AH use at greater than approved doses or greater than local CSU guideline
recommended doses after Screening Visit 1.

8. Previous treatment with biologics: (i) any cell-depleting agents including but not
limited to rituximab within 6 months prior to the baseline visit or until lymphocyte
count returns to normal, whichever is longer; (ii) other biologics, including
investigational biologics (e.g., dupilumab, omalizumab, benralizumab, etc) within 5
half-lives if known or 8 weeks prior to the baseline visit, whichever is longer.

9. Planned or anticipated use of any prohibited medication.

10. Subjects having causes other than CSU for their urticaria including symptomatic
dermographism, cholinergic urticaria, or any inducible urticaria.

11. Subjects with known or suspected urticarial vasculitis.

12. Subjects with known or suspected hereditary angioedema.

13. Any other skin disease associated with chronic itch, including atopic dermatitis, that
in the Investigator's opinion might influence study outcome and subject's
interpretation of symptoms caused by CSU.

14. A helminth parasitic infection diagnosed within 6 months prior to the date that
informed consent is obtained and has not been treated with or has failed to respond to
standard-of-care therapy.

15. Participation in a concurrent interventional study with the last intervention
occurring within 30 days prior to study drug administration (or 90 days or 5
half-lives, whichever is longer, for biologic products).

16. Vaccination with live attenuated vaccines within 30 days prior to initiation of
treatment in the study, during the treatment period, or vaccination expected within 5
half-lives (4 months) of study drug administration. This exclusion criterion does not
apply to all types and formulations of vaccines (including live attenuated vaccines)
currently authorized/approved by FDA or other regulatory authority for the prevention
of COVID-19, which may be administered before, during, or after the study. The vaccine
should not be administered within 3 days before and within 3 days after the
administration of lirentelimab so that any side effects caused by either of the 2
medications can more easily be determined.

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

Eligibility last updated 11/29/22. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Social Determinants of Health in Hepatobiliary Cancer Patients

Hepatobiliary Cancer Patients Social Determinants

Nguyen Tran
All
18 years to 90 years old
This study is NOT accepting healthy volunteers
2022-310192-H01-RST
22-012368
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Inclusion Criteria:

  • ≥ 18 years of age with hepatobiliary cancers and SEA American self-report (they or their family members are from/had been from Cambodia, Laos, or Vietnam) are eligible.
  • Newly diagnosed hepatobiliary cancers.


Exclusion Criteria:
 

  • < 18 years of age. 

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

Eligibility last updated 12/2/22. Questions regarding updates should be directed to the study team contact.

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Exercise Response in Humans with Obesity

Humans With Obesity Response to Exercise

Ian Lanza
All
20 years to 45 years old
This study is NOT accepting healthy volunteers
2022-310195-H01-RST
22-012396
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Inclusion Criteria:

  • Obese men and women ≥ 20 and ≤ 45 years of age. 


Exclusion Criteria:

  • Diabetes or fasting plasma glucose > 126 mg/dL.
  • Anemia (female subjects hemoglobin of < 11 g/dl and male subjects hemoglobin < 12 g/dl).
  • Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment).
  • Renal failure (serum creatinine > 1.5mg/dl).
  • Chronic active liver disease (AST > 144IU/L or ALT > 165IU/L).
  • Oral warfarin group medications or history of blood clotting disorders.
  • Smoking.
  • Pregnancy or breastfeeding.
  • Alcohol consumption greater than 2 glasses/day or other substance abuse.
  • Untreated or uncontrolled hypothyroidism.
  • Debilitating chronic disease (at the discretion of the investigators).

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

Eligibility last updated 11/28/22. Questions regarding updates should be directed to the study team contact.

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Gene transcriptional profile of normal biceps muscle

Normal Biceps Muscle Gene Transcriptional Profile

Peter Rhee
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310205-H01-RST
22-012114
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Inclusion Criteria:

  • ≥ 18 years or age.
  • Undergoing open cubital tunnel release at the level of their elbow will be selected to collect muscle biopsies of their biceps muscle.


Exclusion Criteria:

  • Previous history of peripheral nerve injury involving the musculocutaneous nerve.
  • Previous history of surgery at the level of the arm (fractures around the shoulder or elbow).
  • Medical history of neurological diseases.

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

Eligibility last updated 11/29/22. Questions regarding updates should be directed to the study team contact.

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Prediction of relapse following discontinuation of tocilizumab in patients with giant cell arteritis

Relapse Prediction Following Discontinuation of Tocilizumab In Giant Cell Arteritis

Matthew Koster
All
50 years and over
This study is NOT accepting healthy volunteers
2022-310211-H01-RST
22-012474
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Inclusion Criteria:

  • ≥ 50 years of age.
  • Diagnosis of GCA by confirmation of temporal artery biopsy and/or advanced arterial imaging (CT angiogram, MR angiogram, PET-CT) consistent with large vessel vasculitis.
  • Treated with tocilizumab (subcutaneous OR intravenous) for ≥ 12 months but < 48 months prior to study entry.
  • In clinical remission (that is no symptoms present to suggest active GCA) at study entry.
  • Off prednisone or its equivalent for minimum 2 months prior to study entry.
  • Access to a computer or smartphone/device.


Exclusion Criteria:

  • Uncontrolled diabetes with inability to control glucose level below 200 mg/dl (requirement for obtaining PET-CT).
  • Features of active GCA.
  • Treatment of tocilizumab for other etiologic reason (besides GCA) for which continuation of tocilizumab is deemed necessary (e.g., concomitant rheumatoid arthritis).
  • Ring size smaller than 6 or larger than 13 on digits 2 or 3 (index or middle, respectively).
  • Current (other than non-melanoma skin cancer) malignancy or active infection.

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

Eligibility last updated 11/30/22. Questions regarding updates should be directed to the study team contact.

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A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Encaleret Compared to Standard of Care in Participants with Autosomal Dominant Hypocalcemia Type 1

Peter Tebben
All
16 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-310215-P01-RST
22-012917
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Inclusion Criteria:

  • Participant must be at least 16 years of age, at the time of signing the informed consent or assent.
  • Participants must have a documented pathogenic activating variant, or variant of uncertain significance, of the CASR gene associated with biochemical findings of hypoparathyroidism either present at Screening or a documented history of both:
    • cCa < 8.6 mg/dL (2.2 mmol/L) in participants 16 to < 18 years, or < 8.5 mg/dL (2.1 mmol/L) in participants ≥ 18 years iPTH < 40 pg/mL (4.2 pmol/L);
    • Note: A genetic analysis report for CASR will be acceptable. In the absence of any documentation for the CASR variant, participants must be willing to undergo CASR variant analysis. Participants who have undergone an allogeneic bone marrow transplant must provide either CASR variant analysis report performed prior to the bone marrow transplant or provide a buccal swab for variant analysis. Participants who have received a blood transfusion must wait 2 weeks following the blood transfusion before undergoing CASR variant analysis.
  • Participants must have a documented history of symptoms or signs of ADH1. Symptoms of ADH1 include agitation, anxiety, back pain, brain fog, bronchospasm, blepharospasm, cardiac failure, cognitive impairment, difficulty focusing/concentration, esophageal spasm, facial spasm, headaches, hypoesthesia (including facial and oral), irritability, laryngospasm, muscle cramping, muscle fatigue, muscle spasms, muscle tightness, muscle twitching, musculoskeletal pain, musculoskeletal stiffness, myalgia, nephrolithiasis, nervousness, paresthesia (including oral), polydipsia, polyuria, seizure, tetany, throat tightness, or tremor. Signs of ADH1 include basal ganglia or other cerebral calcification, Chvostek sign, hypercalciuria, nephrocalcinosis, papilledema, premature cataracts, prolonged QT interval on ECG, pseudotumor cerebri, or Trousseau sign.
  • Participants 16 to < 18 years old must have closed growth plates on hand radiograph.
  • Participants treated with thiazide diuretics must discontinue thiazides for at least 14 days prior to Screening through Period 3 Week 24. When the thiazide is being used as an antihypertensive, alternative therapy will be prescribed by the Investigator as needed.
  • Participants treated with phosphate binders must discontinue the phosphate binders at least one day prior to the Screening Visit.
  • Participants treated with magnesium or potassium supplements must be willing to discontinue such treatment prior to the first dose of encaleret.
  • Participants treated with potassium-sparing diuretics must be willing to discontinue such treatment prior to the first dose of encaleret.
  • Participants must meet SoC Optimization criteria.
  • Male participants must use highly effective contraceptive method (eg, condoms with spermicidal gel or foam) during vaginal intercourse and should not father a child nor donate sperm while taking encaleret and for 3 months after the last dose of encaleret. Condoms are not required if the participant is vasectomized or if the participant’s partner is not a female of childbearing potential.
  • Postmenopausal females and females not of childbearing potential may participate in this study without use of contraception:
    • Females are considered postmenopausal if they have had 12 months of natural (spontaneous) amenorrhea without an alternative medical cause and must be confirmed with plasma FSH;
    • Females are considered not of childbearing potential if they have had surgical bilateral oophorectomy (with or without hysterectomy) or hysterectomy. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, shall she be considered not of childbearing potential.
  • Females of childbearing potential, defined as all females physiologically capable of becoming pregnant, must use two highly effective methods of contraception starting at Screening and for 3 months following the last dose of encaleret. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed informed consent or assent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.


Exclusion Criteria:
 

  • cCa and 24-hr UCa both within the respective reference ranges (cCa = 8.6-10.5 mg/dL in participants 16 to < 18 years or 8.5-10.5 mg/dL in participants ≥ 18 years and UCa < 250 mg/day for women and < 300 mg/day for men) at Screening Visit.
    • Note: Exclusion Criteria only applies to participants on SoC who have not participated in CLTX-305-201.
  • History of hypocalcemic seizure within the past 3 months preceding Screening.
  • History of thyroid or parathyroid surgery.
  • Pregnant or nursing (lactating) women, where pregnancy is confirmed by a positive β-hCG laboratory test.
  • History of treatment with PTH 1-84 or 1-34 within the 2 months preceding Screening and requiring SoC doses exceeding > 1.2 × their pre-PTH treatment total daily doses or bone turnover markers, CTx and P1NP, > upper limit of normal for sex, age (men only) and menopausal status (women only).
  • Received any investigational medicinal product other than encaleret within 30 days or 5 half-lives, whichever is longer, prior to the first day on study, or are in follow-up for another interventional clinical study during Screening. If the half-life of an investigational medicinal product is unknown, then 30 days prior to Screening.
  • Blood 25-OH Vitamin D level < 25 ng/mL.
  • If participant has a blood 25-OH Vitamin D level < 25 ng/mL at the Screening Visit, they will be prescribed cholecalciferol or ergocalciferol supplementation per the Investigator. Once the 25-OH Vitamin D level is > 25 ng/mL, the participant will be eligible to enroll in the study (if still within Screening period) or re-screen for the study.
  • Estimated glomerular filtration rate < 30 mL/minute/1.73 m^2 using CKD-EPIcr_R (for participants < 18 years old the Bedside Schwartz equation should be used). 
  • 12-lead resting ECG with clinically important abnormalities except for asymptomatic QTc prolongation clinically ascribed to hypocalcemia.
  • Participants with positive HBsAg, Hepatitis A IgM, or HIV viral serology test at the Screening Visit. Participants who are in complete remission from Hepatitis C as evidence by sensitive assay ≥ 12 weeks after completion of HCV therapy may participate in the study.
  • Male or female participants planning to conceive a child prior to the LTE.
  • Hypersensitivity to any active substance or excipient of encaleret. 
  • Presence or history of any disease or condition (eg, drug or alcohol dependency) that, in the view of the Investigator, would affect the participant’s safety or places the participant at high risk of poor treatment compliance or of not completing the study.

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

Eligibility last updated 11/30/22. Questions regarding updates should be directed to the study team contact.

Dietary Supplement, Drug
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PaSAGE: Patient Centered Approaches to Gene Editing Research (Key Informants) (PASAGE)

Patient Centered Approaches to Gene Editing Research Study

Karen Meagher
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310219-P01-RST
22-012566
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Fall into one of the following categories: clinical geneticist, genetic counselor, scientist, investigator, physician working at, or are members of, professional organizations in the spaces of genetics and/or human reproduction.
  • Willing and able to participate in study activities in either Spanish or English.


Exclusion Criteria:
 

  • Under 18 years of age.
  • Unable or lack the capacity to provide consent; Individuals who are not clinicians or scientists working at, or are members of, professional organizations in the spaces of genetics and/or human reproduction.
  • Does not speak English or Spanish.

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

Eligibility last updated 12/1/22. Questions regarding updates should be directed to the study team contact.

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Outcomes of anterior interosseous nerve transfer to ulnar nerve motor branch in ulnar nerve injuries

Anterior Interosseous Nerve Transfer to Ulnar Nerve Motor Branch Outcomes in Ulnar Nerve Injuries

Steven Moran
All
Not specified
This study is NOT accepting healthy volunteers
2022-310254-H01-RST
22-012619
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Inclusion Criteria:

  • Ulnar nerve injuries:
    • High ulnar nerve traumatic injuries: proximal to the junction of the proximal and middle thirds of the forearm;
    • Severe compression injuries: intrinsic muscle weakness and atrophy.
  • Treated with anterior interosseous to ulnar motor branch nerve transfer performed at Mayo Clinic.
  • More than 1 year follow-up.

Exclusion Criteria

  • Nerve transfer performed at a different hospital.
  • Insufficient follow up and data.

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

Eligibility last updated 12/9/22. Questions regarding updates should be directed to the study team contact.

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Clinical Safety and Performance of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation (VISTA-US) (VISTA-US)

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation (VISTA)

Charanjit Rihal
All
18 years and over
Phase 1, Early Feasibility
This study is NOT accepting healthy volunteers
2022-310255-P01-RST
22-012726
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Inclusion Criteria:

  • Moderate or severe tricuspid valve regurgitation of primary or secondary etiology.
  • Subject is adequately treated with medical therapy for heart failure 30 days prior to index procedure, including a diuretic.
  • Heart Team determines patient is a recommended candidate for the VDyne System.
  • Age 18 years or older.
  • Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for
  • treatment with the VDyne System.


Exclusion Criteria:


VDYNE SYSTEM SUITABILITY

  • Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs.
  • Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed.
  • Hypersensitivity to nickel or titanium.

Clinical Exclusion Criteria (assessed by pre-procedural imaging):

  • Left Ventricular Ejection Fraction (LVEF) < 30%.
  • Severe RV dysfunction.
  • Significant abnormalities of the tricuspid valve and sub-valvular apparatus.
  • Sepsis including active infective endocarditis (IE) (within last 6 months).
  • Right ventricular or atrial thrombus or vegetation.
  • Severe tricuspid annular or leaflets calcification.
  • Systolic pulmonary hypertension with systolic pulmonary artery pressure ≥70 mmHg.

CONCOMITANT PROCEDURES

  • Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease.
  • Any planned surgery or interventional procedure within the period of 30 days prior to 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.
  • Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
  • Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
  • Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
  • Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
  • Prior tricuspid valve surgery or catheter-based therapy with permanent residual devices implanted that would preclude delivery or implantation of the VDyne Valve (e.g., valve replacement, edge to edge repair).
  • Severe valvular heart disease requiring intervention other than the tricuspid valve.
  • Known significant intracardiac shunt (e.g., septal defect) (PFO's without significant shunts are allowed).

COMORBIDITIES

  • Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure.
  • Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids).
  • Acute myocardial infarction (AMI) within 30 days.
  • Significant renal dysfunction (eGFR<30 ml/min/1.73m^2) or on dialysis.
  • End-stage liver disease (MELD > 11 / CHILD class C).
  • Bleeding requiring transfusion within 30 days.
  • Coagulopathy or other clotting disorder that cannot be medically managed.
  • Chronic immunosuppression or other condition that could impair healing response.
  • Any of the following: leukopenia, chronic anemia (Hgb < 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy
  • Unwilling to receive blood products.

General


Exclusion Criteria:

  • Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically.
  • Life expectancy less than 12 months due to non-cardiac comorbidities.
  • Treatment is not expected to provide benefit (futile).
  • Current IV Drug user (must be free drug abuse for > 1 year).
  • Pregnant, lactating or planning pregnancy within next 12 months. (female of child-bearing potential use two reliable contraceptive methods during the study -hormonal methods such as pill and condom).
  • Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees).
  • Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study.
  • Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted.
  • Patient unable or unwilling to comply with study required testing and follow-up visits.

Eligibility last updated 4/14/23. Questions regarding updates should be directed to the study team contact.

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PREVENTABLE SPPB Ancillary

Short Physical Performance Battery Study

Alanna Chamberlain
All
75 years and over
This study is NOT accepting healthy volunteers
2022-310265-P01-RST
22-012753
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Inclusion Criteria:

  • ≥ 75+ years
  • Part of National Patient-Centered Clinical Research Network (PCORnet) and the Veterans Affairs (VA) system.
  • Enrolled in the PREVENTABLE trial.


Exclusion Criteria:
 

  • < 75 years of age. 

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

Eligibility last updated 5/25/23. Questions regarding updates should be directed to the study team contact.

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Single-Arm Phase II Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer Who Are Folate Receptor α Positive

Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Andrea Wahner Hendrickson
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-310286-P01-RST
22-012913
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Inclusion Criteria:

  • Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.
  • Patients must present with stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy.
  • Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FR? positivity.
  • Patients must have a performance status of 0 or 1.
  • Patient's tumor must be positive for FR? expression as defined by a score of PS2+ intensity in > 75% of cells.
  • Patients must have adequate hematologic, liver and kidney functions defined as:
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500/µL);
    • Platelet count ≥ 100 x 10^9/L (100,000/µL) without platelet transfusion in the prior 10 days;
    • Hemoglobin ≥ 9.0 g/dL;
    • Serum creatinine ≤ 1.5 x upper limit of normal (ULN);
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN;
    • Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN);
    • Serum albumin ≥ 2 g/dL.
  • Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.
  • Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) (while on MIRV and for at least 4 months after the last dose.
  • WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV.


Exclusion Criteria:

  • Patients who have previously been treated with a systemic anti-cancer therapy.
  • Patients with low-grade serous, endometrioid, clear cell, or mucinous histology.
  • Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.
  • Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
    • History of hepatitis B or C infection (whether or not on active antiviral therapy);
    • History of human immunodeficiency virus (HIV) infection;
    • Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV.
  • Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome).
  • Patients with clinically significant cardiac disease including, but not limited to, any of the following:
    • Myocardial infarction ≤ 6 months prior to first dose;
    • Unstable angina pectoris;
    • Uncontrolled congestive heart failure (New York Heart Association > class II);
    • Uncontrolled ≥ Grade 3 hypertension (per CTCAE);
    • Uncontrolled cardiac arrhythmias;
    • Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment;
    • Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C);
    • Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis.
  • Patients requiring use of folate-containing supplements (e.g., folate deficiency)
  • Patients with prior hypersensitivity to monoclonal antibodies (mAb)
  • Women who are pregnant or breastfeeding
  • Patients who received prior treatment with MIRV or other FRα-targeting agents
  • Patients with untreated or symptomatic central nervous system (CNS) metastases
  • Patients with a history of other malignancy within 3 years prior to enrollment.
    • Note:  patients with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.

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

Eligibility last updated 12/8/22. Questions regarding updates should be directed to the study team contact.

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Engaging Adolescents in Decisions About Return of Genomic Research Results

Engaging Adolescents in Decisions About Return of Genomic Research Results

Michelle McGowan
All
13 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-310294-P01-RST
22-012883
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Inclusion Criteria:

  • Assenting adolescents (13-17 years).
  • Consenting adolescents (18-21 years).
  • Parent / legal guardian of assenting or  consenting adolescent.
  • Ability to participate in remote study visits, if applicable.


Exclusion Criteria:

  • Individuals who do not meet inclusion criteria.
  • Those who do not communicate in English.
  • Individuals with developmental disabilities that interfere with their ability to make independent decisions.
  • Participants whose permanent address is more than 100 miles from Cincinnati Children's Hospital Medical Center.

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

Eligibility last updated 5/11/23. Questions regarding updates should be directed to the study team contact.

Genetic
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An Open-label Multicenter Phase 2 Dose-evaluation Study of Altropane (123I) Injection for Striatal Dopamine Transporter Visualization Using SPECT Brain Imaging

Altropane Dose for Imaging Patients With Suspected Parkinson's Disease

Derek Johnson
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-310299-P01-RST
22-013009
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Inclusion Criteria:


- For Part 1:

  • the patient has a DaTscan image, obtained within 1 year (preferably within 6 months) before screening, that shows normal striatal uptake; and
  • the patient has a clinical diagnosis (made by a board-certified neurologist who is qualified by training and experience in the diagnosis of movement disorders) that is consistent with the DaTscan image.

For Part 2 (if applicable):

  • the patient has a DaTscan image, obtained within 1 year (preferably within 6 months) before screening, that shows abnormal (unilateral or bilateral reduced) striatal uptake; and
  • the patient also has a confirmed clinical diagnosis of a dPS (such as Parkinson's disease, multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, etc.) made by a board-certified neurologist who is qualified by training and experience in the diagnosis of movement disorders; and
  • the diagnosis is consistent with the DaTscan image.

- The patient is male or female, ≥18 years of age, of any race and ethnicity.

- The patient is able and willing to comply with study procedures and signed and dated informed consent is obtained.

- If the patient is a woman of childbearing potential*, she must use a highly effective method of contraception** from Screening until 30 days after the last administration
of Altropane, and the results of a serum or urine human chorionic gonadotropin (hCG) pregnancy test, performed at Screening and on the day of Altropane administration
(with the result known before Altropane administration), must be negative.

* A woman of childbearing potential is neither post-menopausal nor surgically sterile.  Post-menopausal means having had no menses for at least 12 months without an
alternative medical cause. Surgically sterile means having had a documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, or any combination of these.

** A highly effective method of contraception is one that has a failure rate of less than 1% per year when used consistently and correctly; such methods include combined
(estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only
hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device; intrauterine hormone-releasing system; bilateral
tubal ligation/occlusion; vasectomized partner (with medical confirmation of success); and abstinence from heterosexual intercourse involving a woman of childbearing potential.

- If the patient is a male*** with a sexual partner who is a woman of childbearing potential*, he and his partner must use adequate contraception** from Screening until
30 days after the last administration of Altropane.

(***A male is considered fertile after puberty unless permanently sterile by bilateral orchidectomy, or vasectomized with confirmation of success.)


Exclusion Criteria:


- The patient was previously included in this study.

- Fewer than 7 disintegration half-lives have elapsed between the patient's last procedure (therapeutic or diagnostic) involving a radioisotope and Visit 2 (altropane
SPECT imaging).

- Including participation in this study, the patient's total exposure to radiation during medical procedures/tests in the past year would exceed 50 mSv.

- The patient has participated in an investigational drug or device clinical trial within 30 days before the date of informed consent.

- The patient has any clinically significant or unstable physical or psychological illness, structural brain abnormality, abnormal laboratory results, or abnormal ECG (based on medical history or physical examination at Screening), as determined by the Principal Investigator, that would interfere with study participation.

- The patient has any history of drug or alcohol abuse in the 2 years prior to the date of informed consent.

- The patient has a positive urine screen for drugs of abuse at Screening.

- The patient is a pregnant or breast-feeding female, or is a female of child-bearing potential that is not using appropriate birth control.

- The patient is unable to lie supine for 1 hour.

- The patient has any thyroid disease other than adequately treated hypothyroidism.

- The patient has known or suspected allergy/hypersensitivity to any ingredient in Altropane or to the thyroid blocking medication to be used before imaging.

- The patient is currently taking any of the medications/ treatments listed in the protocol as disallowed and cannot or will not discontinue use at least 12 hours prior to SPECT exam.

- The patient was referred to DaTscan imaging for evaluation of possible cognitive impairment including dementia.

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

Eligibility last updated 11/15/23.  Questions regarding updates should be directed to the study team contact.

 

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Assessment of the Mayo Clinic Vestibular Schwannoma Quality of Life (VSQOL) Index (VSQOL)

Mayo Clinic Vestibular Schwannoma Quality of Life Index Assessment

Kathleen Yost
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310317-H01-RST
22-012993
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Inclusion Criteria:

  • Able to read English fluently.
  • Can consent for themselves.
  • Age 18 years or older.
  • Diagnosis of vestibular schwannoma (also called acoustic neuroma).
  • Prior enrollment in IRB protocol 21-003059.


Exclusion Criteria:

  • Lack of capacity to consent since enrollment in IRB protocol 21-003059.
  • Unable to participate in an interview by Zoom.

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

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

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Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial (C-TRACT)

Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)

Newton Neidert
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2022-310351-P01-RST
22-013113
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Inclusion Criteria:

  • Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease > 3 months duration in a leg with history of DVT, as determined by the site principal investigator or a physician co-investigator; and b) substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, per the same investigator.
  • Ipsilateral iliac vein obstruction documented within 3 months prior to screening by either:
    • Occlusion or >50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS); or
    • Air plethysmography showing deep venous obstruction of the ipsilateral leg (reduced venous outflow fraction), and ultrasound showing echogenic material in the ipsilateral iliac vein and non-phasic continuous Doppler flow in the ipsilateral common femoral vein (CFV) in the presence of normal phasic Doppler flow in the contralateral CFV.


Exclusion Criteria:

  • Age less than 18 years.
  • Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned.
  • Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician.
  • Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein.
  • Absence of PTS of at least moderate severity.
  • Chronic arterial limb ischemia (ankle-brachial index < 0.5 within the previous 1 month) in the ipsilateral leg (if peripheral arterial disease is present or suspected, an ankle-brachial index should be obtained and documented).
  • Presence of open venous ulcer > 50 cm2 area, suspicion for active ulcer infection, or visualization of bone or tendon within the ulcer in the ipsilateral leg.
  • Inability to tolerate endovascular procedure due to acute illness, or general health.
  • Severe allergy to iodinated contrast refractory to steroid premedication.
  • Known allergy to stent or catheter components.
  • Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.05, or platelet count < 75,000/ml.
  • Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min).
  • Disseminated intravascular coagulation or other major bleeding diathesis.
  • Pregnancy (positive pregnancy test).
  • Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS.
  • Inability to provide informed consent or to comply with study assessments.
    • Note:  patients who initially meet an exclusion criterion can have eligibility re-evaluated on a subsequent occasion.

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

Eligibility last updated 12/15/22. Questions regarding updates should be directed to the study team contact.

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Phase 1/2 Multicenter, Open-Label Study of CTX-712 in Patients with Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes

A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes

Antoine Saliba
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2022-310375-P01-RST
23-001738
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML).
  • Prior treatment history must include 1-4 prior lines of therapy.
  • Adequate organ function evidenced by the following laboratory values:
    • Creatinine clearance (CL) ≥ 60 mL/min;
    • Total serum bilirubin < 1.5 × upper limit of normal (ULN);
    • Alanine aminotransferase (ALT) ;
    • Aspartate aminotransferase(AST) < 2.5 × ULN;
    • White blood cell count at the time of the first dose < 10 k/µL.
  • Eastern Cooperative Oncology Group performance status ≤ 2.
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days before study treatment initiation and if sexually active, agree to use a highly effective form of contraception throughout their participation during study treatment and up to 4 months after the last dose of study drug
  • Male patients with female partners of childbearing potential must, even if surgically sterilized, agree to practice effective barrier contraception during the entire study treatment period and through four months after the last dose of study drug, or practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.


Exclusion Criteria:

  • Diagnosis of acute promyelocytic leukemia.
  • Isolated extramedullary relapse (phase 2 only).
  • Active central nervous system (CNS) leukemia.
  • History of other malignancy.
  • Any of the following cardiopulmonary abnormalities:
    • Myocardial infarction within six months prior to registration;
    • New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction < 50%;
    • A history of familial long QT syndrome;
    • Symptomatic atrial or ventricular arrhythmias not controlled by medications;
    • QTcF ≥ 470 msec calculated according to institutional guidelines, unless due to underlying bundle branch block and/or pacemaker and with approval of the medical monitor;
    • Known moderate to severe and clinically significant chronic obstructive pulmonary disease, interstitial lung disease and/or pulmonary fibrosis (e.g., requiring home oxygen therapy).
  • Pregnancy and/or lactation.
  • Major surgery (excluding placement of vascular access) within 4 weeks prior to first dose of CTX-712.
  • History of allogeneic organ transplantation (excluding cornea).
  • History of allogenic hematopoietic stem cell transplantation within 6 months of planned study treatment initiation and/or graft-versus host disease grade ≥ 1 following allogenic hematopoietic stem cell transplantation.
  • History of or chimeric antigen receptor T-cell therapy or other modified T cell therapy.
  • Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus, hepatitis C virus, known human immunodeficiency virus, or acquired immunodeficiency syndrome related illness. Infections controlled with oral anti-infective agents, including prophylactic treatments, are allowed. Patient must be viral load negative.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Eligibility last updated 4/12/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Computer Aided Auscultation (CAA) of Phonoenterogram (PEG) PEG-CAAe for noninvasive diagnosis of patients with bowel diseases

Noninvasive Diagnosis of Patients With Bowel Diseases with Computer Aided Auscultation of Phonoenterogram

Shivaram Poigai Arunachalam
All
18 years and over
This study is NOT accepting healthy volunteers
2022-310381-H01-RST
22-013060
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Inclusion Criteria:

  • Healthy male and female volunteers ≥ 18 years of age.
  • Patients diagnosed with irritable bowel syndrome (IBS) ≥ 18 years of age.
  • Patients with risk of developing POI or with clinical diagnosis ≥ 18 years of age.
  • Patients with evidence of partial bowel obstruction ≥ 18 years of age.


Exclusion Criteria:
 

  • Inability or unwillingness to participate in study.
  • Age ≤ 17 years old.

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

Eligibility last updated 12/19/22. Questions regarding updates should be directed to the study team contact.

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ASCT2031, A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) Versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia or Myelodysplastic Syndrome (MDS)

Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome

Mira Kohorst
All
6 months to 21 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-310422-P01-RST
22-013397
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Inclusion Criteria
•Patient Enrollment:

- 6 months to < 22 years at enrollment.

- Diagnosed with ALL, AML, or MDS for which an allogeneic hematopoietic stem cell
transplant is indicated. Complete Remission (CR) status will not be confirmed at the
time of enrollment. CR as defined in these sections is required to proceed with the
actual HCT treatment plan.

- Has not received a prior allogeneic hematopoietic stem cell transplant.

- Does not have a suitable human leukocyte antigen (HLA)-matched sibling donor available
for stem cell donation.

- Has an eligible haploidentical related family donor based on at least intermediate
resolution HLA typing.

- Patients who also have an eligible 8/8 MUD adult donor based on confirmatory high
resolution HLA typing are eligible for randomization to Arm A or Arm B.

- Patients who do not have an eligible MUD donor are eligible for enrollment to Arm
C.

- 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.

- Co-Enrollment on other trials.

- Patients will not be excluded from enrollment on this study if already enrolled
on other protocols for treatment of high risk and/or relapsed ALL, AML and MDS.
This is including, but not limited to, COG AAML1831, COG AALL1821, the EndRAD
Trial, as well as local institutional trials. We will collect information on all
co-enrollments.

- Patients will not be excluded from enrollment on this study if receiving
immunotherapy prior to transplant as a way to achieve remission and bridge to
transplant. This includes chimeric antigen receptor (CAR) T cell therapy and
other immunotherapies.

Inclusion Criteria
•Patient to Proceed to HCT:


- Karnofsky Index or Lansky Play-Performance Scale ≥60 on pre-transplant evaluation.
Karnofsky scores must be used for patients ≥ 16 years of age and Lansky scores for
patients =< 16 years of age (within 4 weeks of starting therapy).

- A serum creatinine based on age/gender as follows:

6 months to < 1 year: 0.5 mg/dL (Male); 0.5 mg/dL (Female);

1. to < 2 years 0.6 mg/dL (Male); 0.6 mg/dL (Female);

2. to < 6 years 0.8 mg/dL (Male); 0.8 mg/dL (Female);

6 to < 10 years: 1 mg/dL (Male); 1 mg/dL (Female) 10 to < 13 years: 1.2 mg/dL (Male);
1.2 mg/dL (Female) 13 to < 16 years: 1.5 mg/dL (Male); 1.4 mg/dL (Female) >= 16 years:
1.7 mg/dL (Male); 1.4 mg/dL (Female); OR

- A 24 hour urine Creatinine clearance ≥ 60 mL/min/1.73 m^2; OR

- A glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2. GFR must be performed using
direct measurement with a nuclear blood sampling method OR direct small molecule
clearance method (iothalamate or other molecule per institutional standard).

- Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates
are not acceptable for determining eligibility.

- Serum glutamic-oxaloacetic transaminase (SGOT) aspartate aminotransferase [AST] or
serum glutamate pyruvate transaminase (SGPT) aminotransferase [ALT] < 5 x upper limit
of normal (ULN) for age.

- Total bilirubin < 2.5 mg/dL, unless attributable to Gilbert's Syndrome.

- Shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA); OR

- Ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA), choice of
test according to local standard of care.

- Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and
corrected carbon monoxide diffusing capability (DLCO) must all be ≥ 50% of predicted
by pulmonary function tests (PFTs).

- For children who are unable to perform for PFTs (e.g., due to age or
developmental delay), the criteria are: no evidence of dyspnea at rest, oxygen
(O2) saturation (Sat) > 92% on room air by pulse oximetry, not on supplemental O2
at rest, and not on supplemental O2 at rest.

- ALL high-risk in first complete remission (CR1) for whom transplant is indicated.
Examples include: induction failure, treatment failure as per minimal residual disease
by flow cytometry > 0.01% after consolidation and not eligible for AALL1721 or
AALL1721 not available/unwilling to enroll, hypodiploidy (< 44 chromosomes) with MRD+
> 0.01% after induction, persistent or recurrent cytogenetic or molecular evidence of
disease during therapy requiring additional therapy after induction to achieve
remission (e.g. persistent molecular BCR-ABL positivity), T cell ALL with persistent
MRD > 0.01% after consolidation.

- ALL in second complete remission (CR2) for whom transplant is indicated. Examples
include: B-cell: early (≥ 36 months from initiation of therapy) bone marrow (BM)
relapse, late BM relapse (≥ 36 months) with MRD ≥ 0.1% by flow cytometry after first re-induction therapy; T or B-cell: early (< 18 months) isolated extramedullary (IEM),
late (≥ 18 months) IEM, end-Block 1 MRD ≥ 0.1%; T-cell or Philadelphia chromosome positive (Ph+): BM relapse at any time.

- ALL in ≥ third complete remission (CR3).

- Patients treated with chimeric antigen receptor T-cells (CART) cells for whom
transplant is indicated. Examples include: transplant for consolidation of CART, loss
of CART persistence and/or B cell aplasia < 6 months from infusion or have other
evidence (e.g., MRD+) that transplant is indicated to prevent relapse.

- AML in CR1 for whom transplant is indicated. Examples include those deemed high risk
for relapse as described in AAML1831:

- FLT3/ITD+ with allelic ratio > 0.1 without bZIP CEBPA, NPM1;

- FLT3/ITD+ with allelic ratio > 0.1 with concurrent bZIP CEBPA or NPM1 and with
evidence of residual AML (MRD >= 0.05%) at end of Induction;

- Presence of RAM phenotype or unfavorable prognostic markers (other than FLT3/ITD)
per cytogenetics, fluorescence in situ hybridization (FISH), next generation
sequencing (NGS) results, regardless of favorable genetic markers, MRD status or
FLT3/ITD mutation status;

- AML without favorable or unfavorable cytogenetic or molecular features but with
evidence of residual AML (MRD ≥ 0.05%) at end of Induction;

- Presence of a non-ITD FLT3 activating mutation and positive MRD (≥ 0.05%) at end
of Induction 1 regardless of presence of favorable genetic markers;

- AML in ≥ CR2;

- MDS with < 5% blasts by morphology and flow cytometry (if available) on the
pre-transplant bone marrow evaluation;

- Complete remission (CR) is defined as < 5% blasts by morphology and flow cytometry (if
available) on the pre-transplant bone marrow evaluation with minimum sustained
absolute neutrophil count (ANC) of 300 cells/microliter for 1 week or ANC > 500
cells/microliter. We will be collecting data from all approaches to MRD evaluation
performed including NGS and polymerase chain reaction (PCR).

Donor Eligibility Criteria:

- Matched Unrelated Donors:

Unrelated donor candidates must be matched at high resolution at a minimum of 8/8 alleles
(HLA-A, -B, -C, -DRB1). One-antigen HLA mismatches are not permitted. HLA matching of
additional alleles is recommended according to National Marrow Donor Program (NMDP)
guidelines,110 but will be at the discretion of local centers.

- Haploidentical Matched Family Members:

- Minimum match level full haploidentical (at least 5/10; HLA-A, -B, -C, -DRB1,
-DQB1 alleles). The following issues (in no particular order) should be
considered in choosing a haploidentical donor:

- Absent or low patient donor-specific antibodies (DSA);

- Mean fluorescence intensity (MFI) of any anti-donor HLA antibody by
solid phase immunoassay should be < 2000. Donors with higher levels are
not eligible;

- If a screening assay against pooled HLA antigens is used, positive
results must be followed with specificity testing using a single
antigen assay. The MFI must be < 2000 unless the laboratory has
validated higher threshold values for reactivity for HLA antigens
(such as HLA-C, -DQ, and -DP), that may be enhanced in
concentration on the single antigen assays. Donor anti- recipient
antibodies are of unknown clinical significance and do not need to
be sent or reported.

- Consult with Study Chair for the clinical significance of any
recipient anti-donor HLA antibody.

- If centers are unable to perform this type of testing, please
contact the Study Chair to make arrangements for testing.

- If killer immunoglobulin testing (KIR) is performed: KIR status by mismatch,
KIR-B, or KIR content criteria can be used according to institutional
guidelines.

- ABO compatibility (in order of priority):

- Compatible or minor ABO incompatibility

- Major ABO incompatibility

- CMV serostatus:

- For a CMV seronegative recipient: the priority is to use a CMV
seronegative donor when feasible.

- For a CMV seropositive recipient: the priority is to use a CMV
seropositive donor when feasible.

- Age: younger donors including siblings/half-siblings, and second degree
relatives (aunts, uncles, cousins) are recommended, even if < 18 years.

- Size and vascular access appropriate by center standard for peripheral blood stem cell
(PBSC) collection if needed.

- Haploidentical matched family members: screened by center health screens and found to
be eligible.

- Unrelated donors: meet eligibility criteria as defined by the NMDP or other unrelated
donor registries. If the donor does not meet the registry eligibility criteria but an
acceptable eligibility waiver is completed and signed per registry guidelines, the
donor will be considered eligible for this study.

- Human immunodeficiency virus (HIV) negative.

- MUD donors and post-transplant cyclophosphamide haplo donors should be asked to
provide BM. If donors refuse and other donors are not available, PBSC is allowed.
TCR-alpha beta/CD19 depleted haplo donors must agree to donate PBSC.

- Must give informed consent.

- Haploidentical matched family members: Institution standard of care donor consent
and Protocol-specific Donor Consent for Optional Studies.

- Unrelated donors: standard NMDP Unrelated Donor Consent.

- Not pregnant.

Exclusion Criteriam
•Patient Enrollment:


- Patients with genetic disorders (generally marrow failure syndromes) prone to
secondary AML/ALL with known poor outcomes because of sensitivity to alkylator therapy
and/or TBI are not eligible (Fanconi Anemia, Kostmann Syndrome, Dyskeratosis
Congenita, etc). Patients with Downs syndrome because of increased toxicity with
intensive conditioning regimens.

- Patients with any obvious contraindication to myeloablative HCT at the time of
enrollment.

- Female patients who are pregnant are ineligible as many of the medications used in
this protocol could be harmful to unborn children and infants.

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

Exclusion Criteria
•Patient to Proceed to HCT:


- Patients with uncontrolled fungal, bacterial, viral, or parasitic infections are
excluded. Patients with history of fungal disease during chemotherapy may proceed if
they have a significant response to antifungal therapy with no or minimal evidence of
disease remaining by computed tomography (CT) evaluation.

- Patients with active central nervous system (CNS) leukemia or any other active site of
extramedullary disease at the time of initiation of the conditioning regimen are not
permitted.

- Note: Those with prior history of CNS or extramedullary disease, but with no
active disease at the time of pre-transplant workup, are eligible.

- Pregnant or breastfeeding females are ineligible as many of the medications used in
this protocol could be harmful to unborn children and infants.

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

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

Biologic/Vaccine, Drug, Procedure/Surgery, Radiation, Other
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Mayo Clinic — Rochester, MN

A Second Randomized Controlled Trial of Alternating Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection of the Hip or Knee (Apex-2)

A Second Trial of the Abbreviated Protocol Two-Stage Exchange

Rafael Sierra
All
22 years to 84 years old
Phase 2
This study is NOT accepting healthy volunteers
2022-310461-P01-RST
22-013512
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Inclusion Criteria:

  • Scheduled for two-stage exchange arthroplasty due to hip or knee periprosthetic joint infection (PJI).
  • Signed informed consent.
  • 22 to 84 years of age (inclusive).
  • Medical clearance for surgery.
  • Preoperative diagnosis of PJI of the hip or knee per the International Consensus.
  • Meeting of Musculoskeletal Infection (ICMMI) 2018 definition of Periprosthetic Hip andmKnee Infection.


Exclusion Criteria:

  • Patients with 2 or more prior exchange arthroplasties (septic or aseptic) of the infected joint. Exchange of modular components only is not considered an exchange arthroplasty.
  • Patients with 2 or more prior failed spacers for PJI.
  • Patients for whom a Stage 2 procedure within one year is contraindicated.
  • Patients with bacteremia or positive bacterial blood culture in the last 30 days.
  • Patients with concurrent PJI of more than one joint.
  • Patients with ongoing active infection of an intravenous (IV) site.
  • Patients who require long-term anticoagulation or antiplatelet therapy, and for whom bridging or withholding therapy is not recommended based on the individual's clinical condition.
  • Patients with advanced renal insufficiency (i.e., chronic kidney disease Stage 4 or 5 or patients with an estimated glomerular filtration rate < 30 mL/min).
  • Patients on chemotherapy for malignant disease.
  • Patients on systemic glucocorticoid therapy (prednisone >10 mg/day or equivalent).
  • Patients who are immunodeficient (e.g., splenectomy, sickle cell anemia, Stage 3 human immunodeficiency virus infection, primary immunodeficiency disease), except patients who are immunodeficient due to immunosuppressive therapy.
  • Patients who have an allergy to vancomycin hydrochloride or tobramycin sulfate.
    • Note: prior history of red man syndrome is not considered an allergy.
  • Patients who have an allergy to titanium, titanium alloys, polymethylmethacrylate or polyurethane.
  • Patients who are pregnant or planning to become pregnant in the next 12 months.
  • Patients with a fungal PJI as determined by one or more positive fluid and/or tissue cultures.
  • Patients who have a skeletal defect greater than 150 mm in length in the tibia or femur of the infected joint.
  • Patients who have a planned surgical procedure within 6 months of enrollment that can impact the conduct of the study.
  • Patients who are breastfeeding.
  • Patients who are incarcerated or are facing impending incarceration.
  • Patients who have been in treatment or referred to treatment for substance abuse within the past year.
  • Patients with any medical condition, including schizophrenia or another psychiatric disorder with hallucinations and/or delusions, that would interfere with the interpretation of the study results, the conduct of the study, or patient participation would not be in the best interest of the patient in the opinion of the Study Site Principal Investigator.
  • Patients who will participate in another clinical study of an investigational drug or investigational device or have participated in another clinical study of an investigational drug or investigational device within the past 30 days that would interfere with the interpretation of the study results or the conduct of the study.
  • Patients who are judged by the Study Site PI to be unsuitable for the study.
  • Patients receiving immunosuppressive drug therapy for bone marrow or another transplant.
  • Patients currently or previously enrolled in this study or the APEX study (JPS-0301).
  • Patients who receive therapy including any of the following biologic agents, which will not be withheld for a period beginning at least one dosing cycle (minimum 7 days) prior to planned surgery and ending at least 14 days following planned surgery:
    • Adalimumab (Humira); Tocilizumab (Actemra); Etanercept (Enbrel); Anakinra (Kineret);
    • Golimumab (Simponi); Secukinumab (Cosentyx); Infliximab (Remicade); Ustekinumab (Stelara);
    • Abatacept (Orencia); Rituximab (Rituxan); Certolizumab (Cimzia); Tofacitinib (Xeljanz);
    • Belimumab (Benlysta).

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

Eligibility last updated 12/28/22. Questions regarding updates should be directed to the study team contact.

Combination Product, Drug, Procedure/Surgery
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A Phase 1/2, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed OR Refractory Non-Hodgkin Lymphomas (R/R NHL).

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

Grzegorz Nowakowski
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2022-310465-P01-RST
23-000537
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Inclusion Criteria:

  • History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.


Exclusion Criteria:

  • Life expectancy ≤ 2 months.
  • Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter.
  • Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD).
  • Impaired cardiac function or clinically significant cardiac disease.

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

Eligibility last updated 12/29/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug
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Mayo Clinic — Rochester, MN

MUSE Device to Improve Sleep Quality in Midlife Women

A Study of MUSE Device for Midlife Women

Amber Klindworth
Female
45 years to 60 years old
Not Applicable
This study is NOT accepting healthy volunteers
2023-310495-H01-RST
23-000081
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Inclusion Criteria:


- Women in the menopause transition or in menopause, based on clinical assessment.

- PSQI score > 5, with overall sleep quality rating of "fairly bad" or "very bad."

- Motivation VAS score equal to or greater than 5 with overall motivation rating of on a scale of 0-10 with 0 being not motivated at all and 10 being extremely motivated.

- Access to an iPad, iPhone, or android device.

- Have ability to provide informed consent.


Exclusion Criteria:


- Suspected or confirmed obstructive sleep apnea.

- Moderate to severe vasomotor symptoms warranting prescription medication use. The FDA categories for hot flash severity are classified as mild (sensation of heat without sweating), moderate (sensation of heat with sweating, able to continue activity), or severe (sensation of heat with sweating cause cessation of activity).

- Use of hormone therapy or hypnotic agents.

- Use of supplements known to affect sleep.

- A known, active, untreated clinically significant psychiatric condition.

- Use of an investigational drug within 30 days of study enrollment or presence of a known history of any condition or factor judged by the investigator to preclude
participation in the study or which might hinder adherence.

- Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.

Eligibility last updated 8/3/23. Questions regarding updates should be directed to the study team contact.

 

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Mayo Clinic — Rochester, MN

Role of ROS and cAMP-PKA signaling related biomarkers on Renal Disease Severity and Progression in ADPKD

ROS and cAMP-PKA signaling-related biomarkers in ADPKD

Maria Irazabal Mira
All
15 years to 70 years old
This study is NOT accepting healthy volunteers
2023-310503-H01-RST
23-000116
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Inclusion Criteria:

  • Male and female subjects, 15
    •70 years of age.
  • Previous diagnosis of ADPKD (based on Ravine et al. criteria).
  • Class 1 A-E according to imaging classification.
  • Estimated GFR > 45 mL/min/1.73 m^2 (CKD-EPI).
  • Ability to provide written, informed consent.


Exclusion Criteria:

  • Class 2, according to imaging classification.
  • A concomitant systemic disease affecting the kidney.
  • Diabetes mellitus.
  • Predicted urine protein excretion in > 1 g/24 hrs and/or Abnormal urinalysis.
  • Use of antioxidants; i.e., vitamins, Nrf2 activators.
  • Patients that are part of an interventional study.

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

Eligibility last updated 1/5/23. Questions regarding updates should be directed to the study team contact.

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A Single-blind Phase II, Multi-center, Randomized Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients with Hepatorenal Syndrome – Acute Kidney Injury

Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome

Douglas Simonetto
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2023-310537-P01-RST
23-000281
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Inclusion Criteria:

  • Patient is able to communicate well with the Investigator, understands and is willing to comply with all requirements of the study, and understands and signs the written informed consent form (ICF).
  • At least 18 years of age.
  • Cirrhosis and ascites.
  • AKI stage 2 or 3. AKI defined by any of the following:
    • increase in SCr (SCr) ≥ 0.3 mg/dl (or ≥ 26.5 micromolar/L) within 48 h; or
    • increase ≥ 50% in baseline SCr, which is known or presumed to have occurred within the prior seven days.
  • QLY SCr ≥ to 1.5 mg/dl.
  • No sustained improvement in renal function (less than 20% decrease in SCr and SCr ≥ 1.5 mg/dL) after 48 h of diuretic withdrawal and the beginning of plasma volume expansion with albumin.
  • Female patients as well as female partners of male patients must be willing to avoid pregnancy for the duration of the study (> 90 days).


Exclusion Criteria:

  • Significant co-morbidities that in the opinion of the Investigator would preclude study participation.
  • QLY SCr level > 5 mg/dL.
  • AKI stage 1.
  • ACLF stage 3.
  • Model for End-Stage Liver Disease (MELD) score > 35.
  • At least one event of large volume paracentesis (LVP) > 4 Liters in the last 4 days before enrollment.
  • Current or recent (within 4 weeks) treatment with nephrotoxic drugs (e.g., aminoglycosides, amphotericin, cyclosporine, NSAIDS (e.g., ibuprofen, naproxen, celecoxib), significant exposure to radiographic contrast agents (large doses or multiple injections of iodinated contrast media).
  • Shock (hypovolemic-, cardiogenic-, or vasodilatory/distributive shock) with mean arterial blood pressure (MAP) ≤ 70 mmHg or systolic blood pressure ≤ 90 mmHg along with hypoperfusion. 
  • Sepsis or uncontrolled bacterial infection (e.g., persisting bacteremia, persisting ascitic fluid leucocytosis, fever, increasing leucocytosis with vasomotor instability) as measured with the quick sepsis-related organ dysfunction assessment (qSOFA) score.
  • Fewer than two days of anti-infective therapy for documented or suspected infection.
  • Superimposed acute liver injury induced by drugs, herbal preparation or dietary supplements, with the exception of alcoholic hepatitis.
  • Estimated life expectancy less than 5 days.
  • Hypoxia (< 90%) or worsening respiratory symptoms.
  • Proteinuria > 500 mg/day.
  • Tubular epithelial casts, heme granular casts.
  • Haematuria or microhaematuria (more than 50 red blood cells per high power field).
  • Abnormal renal ultra-sonography unless there is a known chronic structural disease (e.g., diabetic or hypertensive nephropathy).
  • Current or recent (within 4 weeks) renal replacement therapy (RRT).
  • Severe cardiovascular and pulmonary diseases including, but not limited to, unstable angina, pulmonary edema, congestive heart failure requiring increasing doses of drug therapy, persisting symptomatic peripheral vascular disease, or any other cardiovascular disease judged by the Investigator to be severe. 
  • Transjugular intra-hepatic systemic shunt (TIPS) unless it is known to be non-functioning or occluded.
  • Ongoing use of vasopressors, unless used for only 48 h before screening; in this case a wash-out period of 8 h before enrollment will be necessary. Patients receiving midodrine and octreotide may be enrolled but treatment must be discontinued prior to enrollment.
  • Known allergy or hypersensitivity to terlipressin or other component of the study treatment.
  • Subject is not suitable to participate in the study for any reason (including, but not limited to co-morbidities, history of non-compliance with study visits, procedures, or drug administration) in the opinion of the Investigator.
  • Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study unless they agree to use highly effective contraception.
  • Males who have no sterilization history and whose female partners have child-bearing potential must agree to use a highly effective method of contraception during the  period from the time of signing the informed consent form (ICF) through 90 days after the last dose of study drug. A male patient must agree to immediately inform the Investigator if his partner becomes pregnant during the study.

Eligibility last updated 5/30/23. Questions regarding updates should be directed to the study team contact.

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Atopic Dermatitis: Evaluation of Baseline Biomarkers and 3D Bioprinted Skin Model

Baseline Biomarkers and 3D Bioprinted Skin Model in Atopic Dermatitis

Saranya Wyles
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310538-H01-RST
23-000324
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Inclusion Criteria:

  • Male and female adults aged ≥ 18 years (at the screening visit) with capacity to consent.
  • Diagnosis of moderate-to-severe Atopic Dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria.
  • AD duration of at least 3 months.
  • IGA score of 2 to 3 at the screening visit.
  • Treatment naïve and/or willing to pursue 30-day wash-out period if they are using topical medications, oral medications, or injectable medications.
  • For participants who sign photography consent, at least 1 target lesion that measures at least 5 cm2 at the screening visit. The target lesion must be representative of the participant's disease state but not located on the hands, feet, genitalia, face, scalp, or intertriginous areas.


Exclusion Criteria:

  • Unstable history of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before baseline/visit 0.
  • Disease history concerns, i.e., lymphoma, immunodeficiency, chronic infections such as HIV, hepatitis, or tuberculosis, dialysis, and/or history of skin cancer within 5 years.
  • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline/visit 0.
  • Active acute bacterial, fungal, or viral skin infection (e.g., herpes simplex, herpes zoster, chicken pox, clinically infected AD, impetigo) within 1 week before the baseline/visit 0.
  • Insufficient area of uninvolved (control) skin.
  • Relative contraindications to skin biopsy (e.g., serum platelets < 10; allergy to lidocaine).
  • Atopic dermatitis exclusive to areas of the hands, feet, face, scalp, intertriginous areas, or genitalia.

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

Eligibility last updated 1/10/23. Questions regarding updates should be directed to the study team contact.

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TRI-QOL. KCCQ Validation in Tricuspid Valve Disease

Tricuspid Valve Disease KCCQ Validation

Shannon Dunlay
All
21 years and over
This study is NOT accepting healthy volunteers
2023-310543-P01-RST
23-000298
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Inclusion Criteria:

  • All race/ethnicity categories, English speaking, men and women.
  • Age ≥ 21 years.
  • Current severe/massive/torrential tricuspid regurgitation (TR), considered symptomatic from TR.
  • Goal Age/Sex/Race Distribution: ≥ 20% non-white, 40% women/men, 40% < 65/ ≥ 65 years of age.

 


Exclusion Criteria:

  • Unwillingness to participate.
  • Cognitive barriers which would make it difficult to participate in discussion.
  • Non-English speaking.

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

Eligibility last updated 1/10/23. Questions regarding updates should be directed to the study team contact.

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Location Contacts
Mayo Clinic — Rochester, MN