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

3159 Study Matches

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Sex Differences in The Objective Assessment of Frailty in Subjects Undergoing Early Outpatient Cardiac Rehabilitation: A Pilot Study

Sex Differences in The Objective Assessment of Frailty in Subjects Undergoing Early Outpatient Cardiac Rehabilitation: A Pilot Study

Carmen Terzic
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305396-H01-RST
21-007783
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Inclusion Criteria:

  • Adult 18 years and older.
  • English speaking.
  • Able to provide consent.
  • Has a qualifying indication for cardiac rehabilitation (e.g., Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, and stable angina, heart valve disease) and able to participate in cardiac rehabilitation.
  • Olmsted County MN residents. 


Exclusion Criteria:

  • Individuals < 18 years of age.
  • Unwilling to provide consent.
  • Unable to participate in cardiac rehab.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

 

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Mayo Clinic — Rochester, MN

Optimizing Outcomes of Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging

A Study Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging

Nguyen Tran
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305399-P01-RST
21-007799
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Inclusion Criteria:

  • Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies.
  • Have radiographically measurable disease by RECIST.
  • Eligible for atezolizumab/bevacizumab front line therapy.
  • Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent.


Exclusion Criteria:

  • Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan.
  • Patients with higher than the weight/size limitations of PET/CT scanner.
Behavioral, Drug, Radiation
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Describing the Determinants and Effects of Variation in the Adoption and Use of the NOHARM Pain Management Intervention Among Diverse Surgical Practices

NOHARM Aim 3

Andrea Cheville
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305410-H01-RST
21-007898
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Inclusion Criteria:

  • Participants eligible for this study will be patients on the NOHARM trial registry (e.g., patients that were automatically assigned to receive the NOHARM intervention as part of their surgical care) and/or their charts and members of their care teams, including nurses, doctors, physical therapists, nurse practitioners and physician assistants, and medical assistants.  


Exclusion Criteria:

  • Individuals not on the NOHARM trial registry.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

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A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-401) Administered to Patients with Acute Myeloid Leukemia (AML) following Hematopoietic Stem Cell Transplantation (ARTEMIS) (MRKR-19-401-01)

AML: Treatment of Relapse after Transplant or Extended Maintenance of Remission – Investigational Study (ARTEMIS) Effectiveness of MT-401 in Patients with AML Following Stem Cell Transplant

Mithun Shah
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305430-P01-RST
21-007911
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Inclusion Criteria:

  • Eligible to receive donor-derived MT-401 following first allogeneic HSCT, are in ≤ second complete remission (CR2), and are MRD negative prior to transplant (including matched sibling, matched unrelated donor with at least 6 of 8 HLA markers, or haploidentical with at least 5 of 10 HLA markers) as:
    • Adjuvant therapy for AML (Group 1) at 90 days (±10 days) post-HSCT defined as patients with CRMRD; or
    • Treatment for relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as
      • First relapse (MRD+ or frank relapse) post-HSCT;
      • Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post-HSCT.
    • Safety Lead-in (Cohorts I and II) and Cohort III defined as patients who fit a majority of the criteria described above for Group 2 only (as determined by the Sponsor).
      • Note: Engraftment must be confirmed post-transplant (absolute neutrophil count > 1000/m^3 without granulocyte colony-stimulating factor for 7 days, donor chimerism ≥ 50%).
    • Are ≥ 18 years of age prior to administration of MT-401.
    • Patients must have donor-derived cells available to make MT-401.
    • Karnofsky/Lansky score of ≥ 60.
    • Life expectancy ≥ 12 weeks.
    • Adequate blood, liver, and renal function.
    • Blood: Hemoglobin ≥ 7.0 g/dL (can be transfused).
    • Liver: Bilirubin ≤ 1.5 X upper limit of normal; aspartate aminotransferase ≤ 3 X upper limit of normal.
    • Renal: Serum creatinine ≤ 2 X upper limit of normal or measured or calculated creatinine clearance ≥ 45mL/min.
    • Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence starting from Screening for T cell infusion until 6 months after the last T cell infusion. Male patients who are sexually active must agree to use a condom during this period.
    • Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant
    • In Group 2, patients may receive bridging therapy at the investigators’ discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit (particularly in cases of high tumor burden) for ≤ 6 months as long as the following criteria are met:
      • Disease assessment including bone marrow biopsy to be performed within 14 days prior to administration of MT-401 (patients may receive MT-401 even if CR is achieved post-bridging therapy but will be analyzed separately; additionally, patients must have ≤ 50% bone marrow blasts);
      • At least 4 half-lives or 1 week has passed after administration of bridging therapy whichever is longer.


Exclusion Criteria:

  • Clinically significant or severely symptomatic intercurrent infection.
  • Pregnant or lactating.
  • For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401.
  • For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401.
  • Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401.
  • Taking systemic corticosteroids (exception: physiological doses of steroids allowed).
  • On other investigational therapy post-HSCT.
  • Anti-thymocyte globulin or Campath within 28 days of MT-401 infusion.

Donor

Inclusion Criteria:

Donors for allogeneic stem cell transplants must be considered suitable for and consent to stem cell donation, as per the stem cell transplant program's standard operating procedures. If a donor has been chosen for the transplant, that same donor will also be used for T cell generation provided that there are no new reasons for ineligibility since the stem cell collection. The donor clearance by the National Marrow Donor Program (NMDP) is acceptable or the donors will be evaluated as per standard institutional guidelines. Leukapheresis material will be collected from the same HSCT donor to manufacture MT-401 for the patient.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

 

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Cardiolipin Profiling for Barth Syndrome Screening and Characterization (CPfBSSaC)

Cardiolipin Profiling for Barth Syndrome Screening and Characterization

Devin Oglesbee
All
Not specified
This study is NOT accepting healthy volunteers
2021-305433-H01-RST
21-007892
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Inclusion Criteria:

  • Specimens (dried blood spots, whole blood, or retrospectively available cultured cells) from Barth subjects and controls identified by the Barth Syndrome Foundation and/or clinical testing at the Mayo Clinic Biochemical Genetics Laboratory.
  • Residual specimens from the Mayo Clinic Biochemical Genetics Laboratory:
    • Up to 1,000 control subjects from pediatric and adult populations through age 99 on date of relevant specimen collection.
  • Data collected as part of the Barth Syndrome Foundation Registry and Biorepository and/or clinical testing at the Mayo Clinic Biochemical Genetics Laboratory.


Exclusion Criteria:

  • None.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

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Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Yogish Kudva
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305450-P01-RST
21-007993
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Inclusion Criteria:


- 18 years of age and older

- Admitted to the hospital in a non-ICU bed or once transferred out of ICU

- Anticipate at least 48 hours of hospital stay

- On treatment for glucose control.

- Willingness to complete the study.

- Willingness to wear up to 3 CGM systems simultaneously. Two in the abdomen and one on
the back of the arm or one on each arm and one on the abdomen.

- Subject and/or caretaker are able to speak, read, and write English


Exclusion Criteria:


- Presence of extensive skin changes/diseases at sensor wear site(s) that preclude
wearing the sensor(s) on normal skin (e.g., extensive psoriasis, recent burns or
severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis
herpetiformis)

- Currently in an intensive care unit (ICU) of the following type (does not apply to
participants placed in an ICU bed due to space issues in the non-ICU areas)

- Known allergy to medical-grade adhesives

- Pregnancy, demonstrated by a positive test (for subjects of childbearing potential)

- Women admitted to give birth or any other admission related to pregnancy

- Patients receiving Hydroxyurea

- Bleeding disorder

- Participants that are currently being treated for malignancies, cancer

- Participant that are hospitalized to receive an organ transplant

- Require a Magnetic Resonance Imaging (MRI) scan

- End stage renal disease and currently managed by dialysis or anticipating initiating
dialysis during the study wear period

- Current participation in another investigational study protocol (If a subject has
recently completed participation in another drug study, the subject must have
completed that study at least 7 days prior to being enrolled in this study.)

- Any condition that, in the opinion of the Investigator, would interfere with their
participation in the trial or pose an excessive risk to study staff (e.g., known
history of hepatitis B or C)

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

Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.

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DP-1111-02CT: A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin (COMPOSE)

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)

Thorvardur Halfdanarson
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305452-P01-RST
21-008020
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Inclusion Criteria:

  • Patients aged ≥ 18 years.
  • Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
  • Somatostatin receptor-positive (SSTR+) disease.


Exclusion Criteria:

  • Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g., rapamycin).
  • Prior (Peptide Receptor Radionuclide Therapy) PRRT.
  • Any major surgery within 4 weeks prior to randomization in the trial.
  • Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
  • Other known malignancies.
  • Serious non-malignant disease.
  • Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
  • Pregnant or breastfeeding women.
  • Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that sense (e.g., persons institutionalized, incarcerated etc.).

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

Drug, Other
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A Phase III, Prospective, Open-Label, Randomized Clinical Trial Evaluating the Augmenting of Anti-SARS-CoV2 Immunity in Kidney Transplant Recipients via Heterologous Prime Booster Vaccination with Janssen Ad26.CoV2.S vaccine

J&J Vaccine Booster in Transplant Recipients

Mark Stegall
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305460-H01-RST
21-008036
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Inclusion Criteria:


Criteria for Entry into the Study:

- Any kidney transplant recipient from Mayo Clinic who has received the mRNA vaccine
(two or three dose mRNA vaccine-Moderna or Pfizer) and are >28 days after most recent
vaccination at the time of spike protein assessment.

- Recipients of a kidney transplant, including those transplanted with other solid organ
transplants in addition to the kidney. Subjects may have received more than 1 kidney
transplant.

- More than 90 days since any transplant including a kidney transplantation. ?≥18 years
of age on the day of consent.

Criteria for Entry into Segment I

- Must have a Roche Elecsys® Anti-SARS-CoV-2 S level of <250 U/mL to be eligible for
Segment I.

- Platelet count of >75,000/µL on the day of vaccination with the Janssen Ad26.CoV2.S
vaccine.

- Contraceptive (birth control) use should be consistent with local regulations
regarding the acceptable methods of contraception for those participating in clinical
studies.

- Before randomization, participants must be either:

- Not be of childbearing potential

- Of childbearing potential and practicing an acceptable effective method of
contraception. Subject must agree to remain on contraception from date of consent
until 3 months after the last dose of the Janssen Ad26.CoV2.S vaccine. Use of
hormonal contraception should start at least 28 days before the 1st
administration of the Janssen Ad26.CoV2.S vaccine. The sponsor-investigator
should evaluate the potential for contraceptive method failure (for example,
noncompliance, recently initiated) in relationship to the Janssen vaccination.
Acceptable effective method a for this study include:

- Hormonal contraception:

- 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 occlusion/ligation procedure

- Vasectomized partner (the vasectomized partner should be the sole partner for
that participant)

- Sexual abstinence (defined as refraining from heterosexual intercourse from the
date of consent until 3 months after the last dose of the Janssen Ad26.CoV2.S
vaccine. The reliability of sexual abstinence needs to be evaluated in relation
to the duration of the study and the preferred and usual lifestyle of the
participant.). Note: Use of condoms is not considered as an acceptable
contraceptive barrier method due to the failure rate of female and male condoms
(Centers for Disease Control and Prevention. Reproductive Health: Contraception.
https://www.cdc.gov/reproductivehealth/contraception/index.htm. Accessed 23
November 2020)

- If subject is female and of childbearing potential, she must:

- Have a negative highly sensitive serum pregnancy test prior to vaccination.

- Participant agrees to not donate bone marrow, blood, and blood products from the first
Janssen Ad26.CoV2.S vaccine administration until 3 months after the last dose of the
Janssen Ad26.CoV2.S vaccine.


Exclusion Criteria:


- Clinically significant acute illness (this does not include minor illnesses such as
diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºCelsius (C)
(100.4°Fahrenheit [F]) within 24 hours prior to the planned 1st dose of the Janssen
Ad26.CoV2.S vaccine; randomization at a later date is permitted at the discretion of
the sponsor-investigator.

- Has a known or suspected allergy or history of anaphylaxis or other serious adverse
reactions to vaccines or their excipients (including specifically the excipients of
the Janssen Ad26.CoV2.S vaccine; refer to the Investigative Brochure).

- Subject has received or plans to receive:

- Licensed live attenuated vaccines -within 28 days before or after planned
administration of the 1st or subsequent Janssen vaccinations.

- Other licensed (not live) vaccines -within 14 days before or after planned
administration of the 1st or subsequent Janssen vaccinations.

- Received an investigational drug within 30 days (including investigational drugs for
prophylaxis of COVID-19) or used an invasive investigational medical device within 30
days of the Janssen Ad26.CoV2.S vaccine. Received investigational Ig or
investigational monoclonal antibodies within 3 months, or received convalescent serum
for COVID-19 treatment within 4 months or received an investigational vaccine
(including investigational Adenoviral- vectored vaccines) within 6 months before the
planned administration of the 1st dose of the Janssen Ad26.CoV2.S vaccine or is
currently enrolled or plans to participate in another investigational study within 3
months after the last Jansen vaccination.

Note: Participation in an observational clinical study is allowed at the
sponsor-investigator's discretion; please notify the sponsor-investigator of this decision.
Efforts will be made to ensure inclusion of participants who have not been previously
enrolled in coronavirus studies. In order to participate subject must agree and understand
that they cannot enroll in other coronavirus focused studies while participating in this
one.

- Is pregnant or planning to become pregnant at the time of consent and within 3 months
of the last dose of the Janssen Ad26.CoV2.S vaccine.

- Has a history of an underlying clinically significant acute or chronic medical
condition or physical examination findings which, in the opinion of the
sponsor-investigator, would make study participation not be in the participant's best
interest (e.g., compromise the well- being) or that could prevent, limit, or confound
the protocol-specified assessments.

- Has a contraindication to Intramuscular (IM) injections and blood draws.

- Has had major psychiatric illness, which in the sponsor-investigator's opinion would
compromise the participant's safety or compliance with the study procedures.

- Cannot communicate reliably with the sponsor-investigator or comply with study
procedures.

- In the opinion of the sponsor-investigator, is unlikely to adhere to the requirements
of the study or is unlikely to complete the full course of protocol required
vaccination and observation.

- History of cancer malignancy within 1 year before screening (exceptions are squamous
and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or other
malignancies with minimal risk of recurrence).

- History of acute polyneuropathy (e.g., Guillain-Barré syndrome)

- Chronic history of platelet count <75,000/µL.

- History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced
thrombocytopenia (HIS).

- History of capillary leak syndrome (CLS).

- Received pre-exposure prophylactic medications for COVID-19 that could interfere with
assessments of any study-related endpoint

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

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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Decreasing Delirium Through Music in Critically Ill Older Adults (DDM)

Decreasing Delirium in Critically Ill Older Adults Through Music

Linda Chlan
All
50 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305465-P01-RST
21-008206
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Inclusion Criteria:

  • Age 50 years or older.
  • English speaking.
  • Admitted to the intensive care unit (medical or surgical).
  • Expected mechanical ventilator support for ≥ 48 hours.
  • Consentable through a legally authorized representative.
  • Have access to a telephone (after discharge).


Exclusion Criteria:

  • History of dementing illnesses and other neurodegenerative diseases such as Alzheimer’s disease or vascular dementia.
  • Psychiatric illness which is not well controlled.
  • Alcohol withdrawal symptoms/concern for withdrawal.
  • Suspected or confirmed drug intoxication/overdose.
  • Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.
  • Uncorrected hearing or vision impairment including legal blindness.
  • Incarcerated at the time of study enrollment.
  • Enrolled in another clinical trial which does not permit co-enrollment.
  • Any medical condition precluding safe use of headphones such as:  skin breakdown, burns, facial or skull fractures.
  • COVID-19 positive test.
Behavioral, Other
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A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Safety and Efficacy of Two Doses of Duloxetine & Amitriptyline in Subjects with Refractory Chronic Cough (MACS-01)

Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough (MACS-1)

Vivek Iyer
All
18 years to 85 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-305482-H01-RST
21-008116
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Inclusion Criteria:

  • Women and men between 18 and 85 years of age.
  • Chest radiograph or computed tomography (CT) of the thorax within the last 1 year not demonstrating any abnormality considered to be significantly contributing to the refractory chronic cough in the opinion of the Principal Investigator.
  • Have a diagnosis of refractory chronic cough or unexplained cough for at least one year.
  • Have a score of ≥ 40mm on the Cough Severity VAS at Screening.
  • Women of child-bearing potential (defined in supplemental section 1, page 64) must agree to use 2 forms of acceptable birth control and make no donation of eggs from Screening through the end of the 8-week study period. Acceptable birth control methods include established use of oral, injected, or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system (IUS); tubal ligation; or male sterilization. Double-barrier method (diaphragm for female subject and condom for male partner with spermicidal) satisfies the requirement for 2 forms of acceptable birth control. When concordant with the preferred lifestyle of the subject, true and complete abstinence (not periodic abstinence) is acceptable.
  • Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control, 1 of which must be a barrier method, and make no donation of sperm from Screening until 3 months after the last dose of study drug at the end of 8 weeks.
  • Have provided written informed consent.
  • Are willing and able to comply with all aspects of the protocol.


Exclusion Criteria:

  • Current smoker (cigarettes, e-cigarettes or marijuana) or former smokers who have smoked within the past 12 months.
  • Former smokers with > 20 pack-year history of smoking.
  • Ongoing treatment with an ACE-inhibitor that is considered as the potential cause of a subject’s cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
  • FEV1/FVC < 60%.
  • History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Screening/Baseline Visit (Day -14 to Day 0).
  • History of opioid use specifically prescribed for chronic cough within 2 weeks of the Screening/Baseline Visit (Day -14 to Day 0). Use of opioids for other indications (for example, to treat pain) is permitted.
  • History of baclofen use specifically prescribed for chronic cough within 2 weeks of the Screening/Baseline Visit (Day -14 to Day 0). Use of baclofen for other indications (for example, to treat spasticity) is permitted.
  • Diagnosis of COPD, bronchiectasis, interstitial lung disease or cystic fibrosis.
  • Presence of an untreated or undertreated cause for the patient’s chronic cough (as determined by the treating/referring physician per ACCP guidelines). e.g. uncontrolled asthma, GERD or post-nasal drainage that could potentially explain the patient’s chronic cough.
  • Requiring concomitant therapy with prohibited medications (see under ‘prohibited concomitant therapy’ on page 28).
  • Treatment with any pharmaceutical or biological investigational therapy (excluding coronavirus disease of 2019 (COVID) vaccination and COVID related monoclonal antibody therapy).
  • Participation in another clinical trial that does not allow co-enrollment within 4 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
  • Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x the upper limit of normal (ULN) during screening.
  • Serum creatinine < 30 mL/min, hemodialysis or peritoneal dialysis.
  • Advanced liver disease as defined by the presence of cirrhosis and/or signs of portal hypertension.
  • History of previous hypersensitivity or intolerance to Duloxetine & Amitriptyline (patients who have previously been on either amitriptyline or duloxetine for chronic cough or other reasons and have tolerated the medication will be offered participation regardless of previous response to therapy).
  • Currently pregnant or breastfeeding female subject.
  • Presence of any medical condition or disability that the investigators believe could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
  • Planned or anticipated major surgical procedure or other activity that would interfere with the subject’s ability to comply with protocol-mandated assessments (e.g., extended travel) during the subject’s participation in the study.
  • Currently taking either another SSRI, SNRI or MAO inhibitor which the patient cannot safely discontinue at least 2 weeks prior to the screening period.

Eligibility last updated 4/15/22. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in TWIN Pregnancy Management (ZTWINS) (ZTWINS)

Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in TWIN Pregnancy Management

Myra Wick
All
0 years to 55 years old
This study is NOT accepting healthy volunteers
2021-305487-P01-RST
21-008126
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Inclusion Criteria:

  • Female patients age 18 at the time of signing informed consent, up to 55 years of age.
  • Ultrasound confirmation of twin pregnancy no later than 20 weeks gestational age (GA), and prior to Panorama.
  • Panorama planned no later than 20 weeks GA.
  • Willing and able to provide written informed consent.
  • Willing and able to comply with institution’s standard of care prenatal procedures, including ultrasound assessments and Panorama.
    • Note: subjects with known major congenital anomalies, known unbalanced chromosomal complement or ruptured membranes, may be enrolled in the study.


Exclusion Criteria:

  • Singleton or non-twin multiple pregnancy.
  • Ultrasound confirmation of twin pregnancy at 20 weeks 1 day GA or later.
  • Patient has received a Panorama test and the enrolling physician has received the Panorama test results prior to any ultrasound assessment of chorionicity & amnionicity.
  • Panorama testing is planned at 20 weeks 1 day GA or later.
  • Any confounding complication or condition that, in the opinion of the investigators, precludes participation in the study, such as evidence of TTTS or other monochorionic pregnancy complication already at the time of enrollment.
  • Unwilling or unable to participate in the institution’s standard of care prenatal ultrasound and/or testing with Panorama.
  • Unwilling or unable to provide written informed consent.

Eligibility last updated 4/26/22. Questions regarding updates should be directed to the study team contact.

 

 

Prenatal care, Antepartum care, Reproductive system, Twin pregnancy
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(ECTx) C4401001 / A Phase I Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PF-07257876 in Patients with Advanced or or Metastatic Tumors (C4401001)

Study to Test the Safety and Tolerability of PF-07257876 in Participants with Selected Advanced Tumors

Saravut Weroha
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305495-P01-RST
21-008170
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Inclusion Criteria:

  • Participants ≥ 18 years old at the screening visit.
  • Histological or cytological diagnosis of advanced/metastatic NSCLC (regardless of subtype) or SCCHN meeting the following criteria:
    • Receipt of exactly 1 prior treatment regimen with a PD-1 or PD-L1 therapy, with or without chemotherapy (in combination or sequentially), in the advanced/metastatic disease setting;
    • No prior immunologic therapy may have been given other than anti-PD-1/PD-L1;
    • Prior chemotherapy is not required; participants may have received up to 2 prior chemotherapy regimens;
    • NSCLC Only: Most recent treatment must have included anti-PD-1/PD-L1 therapy;
    • Prior anti-PD-1/PD-L1 therapy must not have been permanently discontinued due to toxicity.
  • Confirmed radiographic progression of disease must have occurred within the following timeframes:
    • NSCLC: After at least 12 weeks of therapy, during which time the participant had a best response of either CR, PR, or SD (the SD must be >12 weeks). Note: Participants with “pseudo-progression” within this 12-week time period are eligible to enter the study. Pseudo-progression must be decided upon by the investigator, followed by a discussion with the sponsor;
    • SCCHN: After at least 6 weeks of therapy, during which time the participant had a best response of either CR, PR, or SD (SD must be > 6 weeks);
    • NSCLC Only: Confirmed radiographic disease progression must have occurred within < 12 weeks after the last dose of the anti-PD-1/PD-L1 therapy;
    • PD-L1 IHC positivity ≥1% (regardless of CoDx™ assays).
  • At least 1 measurable lesion, as defined by RECIST version 1.1, which has not been irradiated previously.
  • Ovarian cancer.
  • Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high-grade serous component.
  • Platinum-resistant/refractory disease, defined as disease progression within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory), respectively.
  • May have received up to 3 lines of systemic anticancer therapy for platinum-sensitive disease, most recently platinum-containing, and no prior systemic therapy for platinum-resistant or refractory disease. (Note: Receipt of maintenance PARP inhibitor after platinum-containing therapy does not change this criteria). Prior therapy with chemotherapy + bevacizumab for platinum resistant disease is not required.
  • At least 1 measurable lesion, as defined by RECIST version 1.1, that has not been previously irradiated.
  • Must not have received prior anti-PD-1/PD-L1 therapy.
  • PD-L1 IHC positivity ≥ 1% (regardless of CoDx™ assays).
  • ECOG PS 0 or 1.
  • Estimated life expectancy of at least 3 months.
  • Adequate Bone Marrow Function, including:
    • ANC > 1,500/mm^3 or >1.5 x 10^9/L;
    • Platelets > 100,000/mm^3 or >100 x 10^9/L;
    • Hemoglobin >10 g/dL;
  • Adequate Renal Function including:
    • Estimated creatinine clearance ≥ 30 mL/min as calculated using the
      Cockroft-Gault method. In equivocal cases, a 24-hour urine collection test can
      be used to estimate the creatinine clearance more accurately.
  • Adequate Liver Function, including:
    • Total serum bilirubin < 1.5 x ULN;
    • AST and ALT < 2.5 x ULN;
    • < 5.0 x ULN if there is liver involvement by the tumor;
    •  Alkaline phosphatase < 2.5 x ULN (< 5 x ULN in case of bone metastasis).
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1 except for AEs not constituting a safety risk by investigator judgment.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Participants in Part 1 must have recently obtained archival tumor tissue available (collected within 6 months prior to screening) for submission to the sponsor. Participants should have access to formalin-fixed paraffin embedded material containing tumor that is of diagnostic quality and representative of their diagnosed malignancy. If archival sample is older than 6 months, the patient must consent to undergo a de novo biopsy during the screening period. If a new biopsy represents a significant safety risk that can be documented specifically by the Investigator using medical reports, radiographs, or other materials that outline the exact risk involved, the patient may be considered for enrollment, after discussion of the risk with the sponsor.
  • Participants enrolled in the RP2D safety expansion cohort of Part 1 must have a tumor amenable to biopsy and consent to the mandatory paired de novo pretreatment and on-treatment biopsy procedures.
  • All participants in Part 2 must have a tumor amenable to biopsy and consent to undergo a de novo biopsy during screening. Participants entering the study in the subgroup(s) requiring mandatory on-treatment tumor biopsy must consent to these planned biopsy procedures.


Exclusion Criteria:

  • Participants with the finding of any new brain metastases detected by mandatory screening MRI are excluded. Participants may be re-screened for study entry under the following conditions:
    • if the Investigator deems their clinical status acceptable for participation in the trial;
    • all other inclusion and exclusion criteria are  satisfied;
    • corticosteroid treatment for these metastases has been discontinued for at least 4  weeks prior to study entry;
    • neurologically stable by examination and MRI for at least 3 months; 
    • do not require initiation or an increase in anti- epileptic medication for at least 4 weeks prior to start of study treatment; and
    • after discussion with the sponsor. 
    • Note: At the discretion of the sponsor based upon safety findings, screening and on-study MRIs may be removed for all participants during dose escalation.
  • Participants with at least one known brain metastasis larger than 4 cm in longest diameter, or with any known brain metastasis that is symptomatic.
  • Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, recovered from the acute effects of radiation therapy or surgery prior to study entry (Day 1), and meet the following criteria
    • if the Investigator deems their clinical status acceptable for participation in the trial;
    • all other inclusion and exclusion criteria are satisfied;
    • corticosteroid treatment for these metastases has been discontinued for at least 4 weeks prior to study entry;
    • neurologically stable by examination and MRI for at least 3 months;
    • do not require initiation or an increase in anti-epileptic medication for at least 4 weeks prior to start of study treatment; and
    • after discussion with the sponsor.
  • Participants with abnormal neurologic examination by the investigator.
  • Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. Participants with a history of other curatively treated cancers may be eligible, after discussion and review by the sponsor.
  • Non-epithelial tumor or ovarian tumor with low malignant potential (i.e., borderline tumors).
  • Known or suspected hypersensitivity to PF-07257876 components.
  • Major surgery within 4 weeks prior to planned first dose.
  • Radiation therapy with treatment intent within 4 weeks prior to study entry. Any palliative radiation therapy must be completed within the 7 days prior to C1D1.
  • Irradiation to > 25% of the bone marrow.
  • Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis, or melena in the past 6 months.
  • History of Grade ≥ 3 immune-mediated AE (including AST/ALT elevations that where considered drug-related and CRS) that was considered related to prior immune modulatory therapy (e.g., immune CPIs, costimulatory agents, etc) and required immunosuppressive therapy. Participants with immune-mediated endocrinopathies controlled with hormonal replacement therapy (e.g., thyroid disorders, diabetes, adrenal insufficiency) are eligible.
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic
    organizing pneumonia), evidence of active pneumonitis on screening chest CT scan.
    • Note: A history of radiation pneumonitis (localized pulmonary fibrosis) in the field of prior radiation therapy is not exclusionary.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.

Eligibility last updated 8/16/21. Questions regarding updates should be directed to the study team contact.

 

 

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Prospective Biobanking Study in Immunodeficiency Patients

Biobanking Study in Immunodeficiency Patients

Avni Joshi
All
Not specified
This study is NOT accepting healthy volunteers
2021-305635-H01-RST
21-008664
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Inclusion Criteria:

  • Capable and willing to provide informed consent.
  • Confirmed or suspected physician diagnosis of Primary Immunodeficiency.


Exclusion Criteria:

  • Not willing to provide consent.
  • Not diagnosed with Primary Immunodeficiency.

Eligibility last updated 9/10/21. Questions regarding updates should be directed to the study team contact.

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Phase 1-2a Safety, Tolerability, and Pharmacodynamics Controlled Study of NOV-001 in Healthy Volunteers and Patients with Enteric Hyperoxaluria (NOV-001-CL01)

Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects

John Lieske
All
18 years to 65 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2021-305641-P01-RST
21-008943
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Stage 1 Key

Inclusion Criteria:


- Ages 18 to 55

- Body mass index (BMI) < 38 kg/m2.

- Healthy as defined by no clinically relevant abnormalities being identified by a
detailed medical history, physical examination, and clinical laboratory tests.

- If woman of child-bearing potential, must not be pregnant, and must also agree to use
an appropriate highly-effective contraceptive.

- Willing and able to comply with all study requirements, including duration of stay at
inpatient unit, dietary restrictions, daily study product administration, pregnancy
testing and contraception (if applicable), stool collections, and blood and urine
collections.

Stage 1 Key
Exclusion Criteria:


- Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m2 at Screening.

- Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of
the need for such antibiotics during the Screening or treatment periods of the study.

- Current or history of any clinically significant medical illness or disorder the
Investigator considers should exclude the subject from the study.

- Participation in any investigational intervention study within 30 days prior to study
product administration in this study.

- Known hypersensitivity to omeprazole.

- Applicable only to certain study groups depending on emerging Stage 1 data: no current
or anticipated use during the screening or treatment periods of the study of
medications that have the potential for drug-drug interactions (DDI) with omeprazole.

Stage 2 Key
Inclusion Criteria:


- Ages 18 to 65.

- Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery or to biliopancreatic
diversion with duodenal switch (BPD-DS) surgery.

- 24-Hour urinary oxalate (UOx) ≥ 60 mg.

- If woman of child-bearing potential, must not be pregnant and must also agree to use
an appropriate highly effective contraceptive method.

- Must, in the opinion of the Investigator, be in otherwise good health.

- Willing and able to comply with all study requirements, including dietary
restrictions, daily study product administration, pregnancy testing and contraception
(if applicable), stool collections, and blood and 24-hour urine collections.

Stage 2 Key
Exclusion Criteria:


- Chronic kidney disease with eGFR < 30 mL/min/1.73 m2 at Screening.

- Evidence of current acute renal injury or ongoing clinically significant renal
disease.

- Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of
the need for such antibiotics during the Screening or treatment periods of the study
(topical antibiotics are permissible.)

- Taking during the study any treatment for hyperoxaluria except for NOV-001, other than
stable treatments for the management of kidney stones.

- Taking Vitamin C ≥ 300 mg/day for > 10 days within 7 days prior to Screening;
unwilling or unable to discontinue and/or avoid Vitamin C supplementation for the
duration of study product treatment.

- Known active autoimmune disorder or other condition requiring high dose of systemic
corticosteroids (i.e., > 10 mg/day prednisone or equivalent) or other
immunosuppressant therapy.

- Current or history of any clinically significant medical illness or disorder other
than enteric hyperoxaluria that the Investigator considers should exclude the patient
from the study.

- Participation in any investigational intervention study within 30 days prior to study
product administration in this study.

- Known hypersensitivity to omeprazole.

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

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

Biologic/Vaccine, Drug, Other
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(ECTx) ELU-FRa-1 / Dose Escalation and Expansion Clinical Study to Evaluate the Safety and Efficacy of ELU001 in Subjects Who Have Advanced, Recurrent or Refractory FRα Overexpressing Tumors (ELU-Fra-1)

A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)

Wen Wee Ma
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-305646-P01-RST
21-008883
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​​​​​

Inclusion Criteria:

  • Male or female subjects aged 18 or older at the time of signed informed consent.
  • In the opinion of the Investigator, there is no other meaningful life-prolonging therapy option available.
  • Population:
    • Part 1: Must have documented diagnosis of ovarian cancer, endometrial cancer, colorectal cancer, gastric cancer, gastroesophageal junction cancer, triple negative breast cancer, non-small cell lung cancer, or cholangiocarcinoma.
    • Part 2 Stage 1: Must have one of the following cancer types indicated below with the corresponding expression level of FRα.:
    • Ovarian Cancer
      • Moderate and/or High
    • Endometrial Cancer
      • Moderate and/or High
    • Colorectal Cancer
      • Moderate and/or High
    • Gastric Cancer
      • Moderate and/or High
    • Gastroesophageal Junction Cancer
      • Moderate and/or High
    • Triple Negative Breast Cancer
      • Moderate and/or High
    • Non-small cell lung cancer
      • Moderate and/or High
    • Cholangiocarcinoma
      • Moderate and/or High
    • Specific cancer types from the table above will be selected by the Sponsor, in consultation with the Part 1 CSRC and other experts, at the conclusion of Part 1 Dose Escalation. In addition, moderate and high FRα expression thresholds will be defined and communicated by the Sponsor to Investigators upon completion of translational testing prior to the start of Part 2.

Part 2 Stage 2 or Registration Study:

  • Must have documented FRα expression in one of the topoisomerase 1 inhibitor-sensitive tumor types evaluated in Part 2 Stage 1. Specific tumor groups will be selected by the Sponsor, in consultation with the CSRC and/or Steering Committee (SC) and other experts, at the conclusion of Part 2 Stage 1.
  • Folate receptor α (FRα) expression:
    • Part 1: Must provide archival tumor tissue or a newly obtained tumor biopsy specimen prior to the first dose of study drug for retrospective FRα expression analysis. The availability of the FRα expression result is not required to start study drug administration.
    • Part 2: Must provide archival tissue or a newly obtained tumor biopsy specimen prior to the first dose of study drug for prospective determination of FRα overexpression at the Sponsor-designated laboratory. The FRα expression result is required prior to the initiation of study drug administration.
  • In Part 1, measurable disease or, in the absence of measurable disease, non-measurable disease (lesions considered truly non-measurable include leptomeningeal disease, ascites, pleural or pericardial effusion, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques), as per RECIST v1.1. In Part 2, measurable disease (only), as per RECIST v1.1.
    • Note:  A lytic or mixed lytic-blastic bone lesion with a soft tissue component assessed on CT/MRI can be measurable if the minimum size criteria are met.
  • For other criteria, refer to RECIST v1.1.
  • Expected survival of at least 3 months.
  • In Part 1, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or 2.
  • In Part 2, ECOG Performance Status of 0 or 1.
  • Adequate organ function defined as:
    • Absolute neutrophil count ≥ 1,500/μL;
    • Platelets ≥ 100,000/μL;
    • Hemoglobin ≥ 8 g/dL;
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (including subjects with documented Gilberts syndrome, liver metastases, or other etiologies);
    • Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 5 x ULN;
    • Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault equation.
  • Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug.
  • For women of childbearing potential, willingness to avoid pregnancy by using an effective method of contraception from the first dose of ELU001 up to 5 times the half-life of ELU001 treatment (about 10 days) plus 6 months after the last dose of study drug (or longer, if required by Regulatory Authority or local practice).
  • For males who are capable of fathering a child, willingness to take precautions that are effective in preventing pregnancy from the first dose of ELU001 and up to 5 times the half-life of ELU001 treatment (about 10 days) plus 3 months after the last dose of study drug (or longer, if required by Regulatory Authority or local practice).
  • Willing and able to understand and comply with all aspects of the protocol.
  • Provided informed consent prior to any protocol-related procedures, including screening evaluations.


Exclusion Criteria:

  • Clinically significant active or chronic corneal disorder.
  • Received investigational anti-cancer treatment, other anti-neoplastic therapy, including cytotoxics, targeted agents, biological therapy including antibodies and endocrine therapies ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, prior to starting study drug, whichever is shorter.
  • Require use of folate-containing supplements during the treatment period.
  • Known medical history of:
    • Clinically significant cardiovascular and respiratory conditions including myocardial infarction within 1 year, uncontrolled or unstable angina, congestive heart failure (New York Heart Association [NYHA] Class III or IV), or arrhythmia (Grade 2 or higher), within 5 years;
    • Another malignancy within 3 years before the first dose, or previously diagnosed with another malignancy, and have any evidence of residual disease. Subjects with non-melanoma skin cancer or cervix carcinoma in situ, treated and radiated early prostate cancer if they have undergone complete resection, or chronic lymphocytic leukemia (CLL) who is on close monitoring and treatment is not required, are not excluded;
    • Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment;
    • Serious, uncontrolled medical disorder such as seizures, nonmalignant systemic disease, or active, uncontrolled infection or active infection causing fever. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. Subjects with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension (< 150 systolic blood pressure [sBP] and < 90 diastolic blood pressure [BP]) are eligible;
    • Part 1 only: Recognized immunodeficiency condition including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, or congenital immunodeficiency’s (human immunodeficiency virus (HIV) infection, see below).
  • Any of the following conditions (testing is not required in this protocol, unless required by Regulatory Authority or local practice)
    • Known HIV-infected subjects, unless on effective anti-retroviral therapy with an undetectable viral load within 6 months; or
    • Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable Hepatitis B Virus (HBV) viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion); or
    • Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load.
  • Active medical conditions of:
    • Subjects in Part 1 with autoimmune disease (e.g., rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), ulcerative colitis, Crohn's Disease, Multiple Sclerosis (MS), ankylosing spondylitis, thyroiditis) requiring continuing immune suppressive therapy;
    • Subjects in Part 1 with brain or leptomeningeal metastases; in Part 2, subjects with symptomatic brain or leptomeningeal metastases with any lesion greater than 3 cm, or evidence of herniation or hemorrhage.
  • Any of the following recent treatments or therapies:
    • Subject has received a transfusion (platelets or red blood cells) ≤ 2 weeks prior to first dose of study drug;
    • Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent in Part 1, except for inhalers or those on a pre-planned steroid taper.
    • Note: Premedication with corticosteroids to prevent or decrease the severity of infusion related reactions per institutional standard of care is allowed;
    • Chronically treated with systemic doses of other immunosuppressive drugs such as cyclosporine, methotrexate, adrenocorticotropic hormone (ACTH) or immune suppressive monoclonal antibodies.
  • Female subjects who are lactating or breast feeding or have a positive pregnancy test within 7 days prior to first dose of study drug.
  • Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study drug, interfere with subject compliance or conduct of this study.
  • In the opinion of the Investigator, there is significant risk to a subject when the tumor tissue biopsy specimen procedure is performed
  • Subjects who have a QTcF > 470 ms within 4 weeks prior to the first dose of study drug.

Eligibility last updated 10/26/22. Questions regarding updates should be directed to the study team contact.

 

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An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants With Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants

Martha Grogan
All
18 years to 90 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-305651-P01-RST
21-008725
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Inclusion Criteria:


1. Completed 30 months of the blinded study treatment in Study AG10-301 and the Study
AG10-301 Month 30 visit including assessments and procedures.

2. Have the ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures.

3. Female participants of childbearing potential who engage in heterosexual intercourse
must agree to use a highly effective method of contraception beginning with enrollment
and continuing for 30 days after the last dose of acoramidis. Female participants
using oral contraceptives must agree to use an additional birth control method. While
not considered highly effective, a double-barrier method is acceptable. A male
participant who is sexually active with a female of childbearing potential and has not
had a vasectomy must agree to use a double-barrier method of birth control.


Exclusion Criteria:


1. Acute myocardial infarction, acute coronary syndrome or coronary revascularization
within 90 days prior to Day 1 stroke or transient ischemic attack (TIA) within 90 days
prior to Day 1.

2. Has hemodynamic instability, that in the judgment of the Investigator, would pose too
great a risk for participation in the study.

3. Has had a heart and/or liver transplant or is on the heart transplantation list within
the year prior to Day 1

4. Has had implantation of a cardiac mechanical assist device (CMAD) or is scheduled for
implantation of a CMAD

5. Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during Study
AG10-301.

6. Has estimated glomerular filtration rate (eGFR) by modification of diet for renal
disease (MDRD) formula < 15 mL/min/1.73 m2 at Month 27 of Study AG10-301 or at any
subsequent central lab value prior to Day 1.

7. Known hypersensitivity to acoramidis, its metabolites, or formulation excipients.

8. At the end of Study AG10-301 or at Day 1 of Study AG10-304 (or any time during the
study), participant is on prohibited medication.

9. Females who are pregnant or breastfeeding. A negative urine pregnancy test at the Day
1 visit and at each study visit are required for female participants of childbearing
potential.

10. In the judgment of the Investigator or Medical Monitor, has any clinically important
ongoing medical condition or laboratory abnormality or condition that might jeopardize
the participant's safety, increase their risk from participation, or interfere with
the study.

11. Participation in another interventional clinical trial (with the exception of Study
AG10-301) within 30 days prior to dosing. Participation in observational and/or
registry studies should be discussed with the Medical Monitor.

12. Has any condition that in the opinion of the Investigator or Medical Monitor would
preclude compliance with the study protocol such as a history of substance abuse,
alcoholism, or a psychiatric condition.

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

Eligibility last updated 8/24/22. Questions regarding updates should be directed to the study team contact.

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The Role Of Interferon-gamma In Immune Responses To Invasive Candidiasis (Candiada)

The Role Of Interferon-gamma In Invasive Candidiasis

Paschalis Vergidis
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305653-H01-RST
21-008735
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Inclusion Criteria

  • Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
  • Males or females ≥ 18 years of age.
  • Evidence of candidemia or invasive candidiasis based on growth of Candida species from any of the following: blood, peritoneal fluid, intra-abdominal collection/abscess, pancreatic fluid/tissue, peripancreatic fluid, pleural fluid/tissue.


Exclusion Criteria:

  • Severe neutropenia (absolute neutrophil count < 500 cells/microL).
  • Profound lymphopenia (< 300 cells/microL).
  • The Principal Investigator (PI) is of the opinion that the subject should not participate in the study.

Eligibility last updated 8/23/21. Questions regarding updates should be directed to the study team contact.

 

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Genomic and Environmental Basis of Imperforate Anus (IA)

Genomic and Environmental Basis of Imperforate Anus

Lisa Schimmenti
All
Not specified
This study is NOT accepting healthy volunteers
2021-305657-H01-RST
21-008736
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Inclusion Criteria:

  • Diagnosis of imperforate anus.


Exclusion Criteria:
 

  • Lack of a parent or guardian to provide informed consent.

Eligibility last updated 9/24/21. Questions regarding updates should be directed to the study team contact.

 

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

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

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


- Participants must satisfy the following criteria to be enrolled in the study:

1. Is ≥ 18 years of age at the time of signing the informed consent form (ICF).

2. Participant has histologically confirmed (per local evaluation) diagnosis of de
novo, previously untreated, a-BCL according to 2016 WHO classification.

3. Participant has International Prognostic Index (IPI) score 0-5 in Part 1 and IPI
2-5 in Part 2.

4. Participants must have measurable disease defined by at least one FDG-avid lesion
for FDGavid subtype and one bi-dimensionally measurable (> 1.5 cm in longest
diameter) disease by computed tomography (CT) or magnetic resonance imaging
(MRI), as defined by the Lugano classification (Cheson, 2014).

5. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status
of 0, 1, or 2.

6. Participants must have the following laboratory values:

1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L in case of
documented bone marrow involvement (> 50% or tumor cells), without growth
factor support for 7 days (14 days if peg-G-CSF)

2. Hemoglobin (Hb) ≥ 8 g/dL

3. Platelets (PLT) ≥ 75 x 109/L or ≥ 50 x 109/L in case of documented bone
marrow involvement (>50% or tumor cells), without transfusion for 7 days

4. Aspartate aminotransferase / serum glutamic oxaloacetic transaminase
(AST/SGOT) and alanine aminotransferase / serum glutamate pyruvic
transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In the case of
documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤
5.0 x ULN.

5. Serum total bilirubin ≤ 2.0 mg/dL except in cases of Gilbert syndrome, then
≤ 5.0 mg/dl

6. Estimated serum creatinine clearance of ≥ 50 mL/min

7. All participants must:

1. Have an understanding that the study drug could have a potential teratogenic
risk.

2. Agree to follow all requirements defined in the Pregnancy Prevention Program
for CC-220 or CC-99282 Pregnancy Prevention Plan for Participants in
Clinical trials.

8. Females of childbearing potential (FCBP) must:

a. Have two negative pregnancy tests as verified by the investigator prior to
starting study therapy.

9. Male participants must:

1. Practice true abstinence or agree to use a condom during sexual contact with
a pregnant female or a female of childbearing potential while participating
in the study.


Exclusion Criteria:


- The presence of any of the following will exclude a participant from enrollment:

1. Any significant medical condition, active infection (including SARS-CoV-2
suspected or confirmed), laboratory abnormality, or psychiatric illness that
would prevent the participant from participating in the study.

2. Any condition including the presence of laboratory abnormalities, which places
the participant at unacceptable risk if he/she were to participate in the study.

3. Any other subtype of lymphoma.

4. Documented or suspected CNS involvement by lymphoma.

5. Persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical
management.

6. Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0).

7. Chronic systemic immunosuppressive therapy or corticosteroids

8. Impaired cardiac function or clinically significant cardiac disease, including
any of the following:

a. Left ventricular ejection fraction (LVEF) < 45% as determined by multigated
acquisition scan (MUGA) or echocardiogram (ECHO)

9. Major surgery ≤ 2 weeks prior to starting CC-220 or CC-99282; participant must
have recovered from any clinically significant effects of recent surgery.

10. Any condition causing inability to swallow tablets.

11. Known seropositivity for or active viral infection with human immunodeficiency
virus (HIV)

12. Known chronic active hepatitis B (hepatitis B surface antigen [HBsAg] positive
and/or hepatitis B core antibody [anti-HBc] positive with viral DNA positive) or
C (positive serology requiring treatment and/or with evidence of liver damage)
infection

13. History of other malignancy, unless being free of the disease for ≥ 3 years;
exceptions to the ≥ 3-year time limit include history of the following:

1. Localized nonmelanoma skin cancer

2. Carcinoma in situ of the cervix

3. Carcinoma in situ of the breast

4. Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor
Node Metastasis [TNM] staging system) or prostate cancer that has been
treated with curative intent.

14. Hypersensitivity to the active substance or to murine proteins, or to any of the
other excipients of rituximab.

15. Known hypersensitivity to any component of CHOP regimen.

16. Known allergy to thalidomide, pomalidomide, or lenalidomide.

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

Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact.

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A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients with Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab (HZNP-TEP-402)

TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study

Marius Stan
All
18 years to 80 years old
Phase 4
This study is NOT accepting healthy volunteers
2021-305679-P01-RST
21-008801
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Inclusion Criteria:

  • Written informed consent.
  • Male or female between the ages of 18 and 80 years, inclusive, at Screening.
  • Initial diagnosis of TED within 7 years prior to Screening.
  • Proptosis ≥ 3 mm from baseline (prior to diagnosis of TED), as estimated by treating physician, and/or proptosis > 3 mm above normal for race and gender.
  • Participants must be euthyroid with the baseline disease under control or have mild hypo or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels < 50% above or below the normal limits) at Screening. Every effort should be made to correct the mild hypo- or hyperthyroidism promptly and to maintain the euthyroid statefor the durat ion of the trial.
  • Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the course of the trial.
  • Diabetic participants must have HbA1c ≤ 8.0% at Screening.
  • Participants with a history of IBD (ulcerative colitis or Crohn's disease) must be in clinical remission for at least 3 months, with no history of bowel surgery within 6 months prior to Screening and no planned surgery during the trial. Concomitant stable therapies for IBD without modifications in the 3 months prior to Screening are allowed.
  • Women of childbearing potential (including those with an onset of menopause < 2 years prior to Screening, non-therapy-induced amenorrhea for < 12 months prior to Screening or not surgically sterile [absence of ovaries and/or uterus]) must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified time points (i.e., prior to each dose and throughout the participant's participation in the Follow-up Period); participants who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the trial, 1 of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started at least 1 full cycle prior to Baseline and continue for 180 days after the last dose of teprotumumab. Highly effective contraceptive methods (with a failure rate < 1% per year), when used consistently and correctly, include implants, injectables, combination oral contraceptives, some intrauterine devices, tubal ligation, sexual abstinence or vasectomized partner.
  • Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.


Exclusion Criteria:

  • Decreased best-corrected visual acuity due to optic neuropathy, as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect or color defect secondary to optic nerve involvement within the last 6 months.
  • Corneal decompensation unresponsive to medical management.
  • Decrease in proptosis of ≥ 2 mm in the study eye between Screening and Baseline.
  • Prior orbital irradiation, orbital decompression or strabismus surgery.
  • Planned eyelid surgery during the course of the trial.
  • Alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal or estimated glomerular filtration rate ≤ 30 mL/min/1.73m^2 at Screening.
  • Use of any steroid (intravenous [IV], oral, steroid eye drops) for the treatment of TED or other conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids, as well as steroids used to treat infusion reactions.
  • Any treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion of teprotumumab or tocilizumab (Actemra® or Roactemra®) within 6 months prior to the first infusion of teprotumumab. Use of any other non-steroid immunosuppressive agent within 3 months prior to the first infusion of teprotumumab.
  • Any previous treatment with teprotumumab, including previous enrollment in this trial or participation in a prior teprotumumab trial.
  • Treatment with any mAb within 3 months prior to Screening.
  • Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude trial participation or complicate interpretation of trial results.
  • Use of an investigational agent for any condition within 60 days or 5 half-lives, whichever is longer, prior to Screening or anticipated use during the course of the trial.
  • Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
  • Pregnant or lactating women.
  • Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the participant.
  • Known hypersensitivity to any of the components of teprotumumab or prior hypersensitivity reactions to mAbs.
  • Human immunodeficiency virus, untreated or positive viral load for hepatitis C or hepatitis B infections.
  • Any other condition that, in the opinion of the Investigator, would preclude inclusion in the trial.
  • After 150 participants with a CAS < 3 at Baseline have been randomized, an additional exclusion criterion will apply: CAS < 3 at Baseline.

Eligibility last updated 10/13/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Other
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Contrast Enhanced Breast PCD-CT Compared to MR or mammogram for Staging of Breast Cancer in the Breast and Regional Nodes

Breast MR

Katrina Glazebrook
Female
18 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-305687-H01-RST
21-008825
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Inclusion Criteria:

  • Adult female patients 18 to 99 years of age.
  • Patients with proven breast cancer and nodal metastases referred for staging breast MR within the Department of Radiology.
  • Patients who are able and willing to sign the informed consent.
  • Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient).


Exclusion Criteria:

  • Minors under 18 years of age.
  • Patients unable to provide written informed consent.
  • Pregnancy.
  • eGFR ≤ 30 (4,5).
  • History of prior moderate or severe contrast reaction including unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
  • Any history of premedication prior to iodinated contrast.
  • Patients that consent to participation but do not undergo their clinically indicated MR scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).

Eligibility last updated 8/24/21. Questions regarding updates should be directed to the study team contact.

 

 

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Patient Derived Preclinical Models

Patient Derived Preclinical Models

Aaron Mansfield
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305691-H01-RST
21-008831
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Inclusion Criteria:

  • 18 years of age and older.
  • Patient is a good medical candidate for a standard of care or research biopsy or surgical procedure to obtain tissue.


Exclusion Criteria:

  • Individuals < 18 years of age.
  • Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
  • Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use.
  • Biopsy must not be considered to be more than minimal risk to the patient.
  • Have a contraindication to percutaneous biopsy including:
    • Significant coagulopathy that cannot be adequately corrected;
    • Severely compromised cardiopulmonary function or hemodynamic instability;
    • Lack of a safe pathway to the lesion per the interventional radiologist;
    • Inability of the patient to cooperate with, or to be positioned for, the procedure.

Eligibility last updated 8/23/21. Questions regarding updates should be directed to the study team contact.

 

 

Procedure/Surgery
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Immune Profiling in Kidney Transplant Recipients and Living Kidney Donors

Immune Profiling of Kidney Transplant Recipients and Living Kidney Donors

Mark Stegall
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305694-H01-RST
21-008777
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Inclusion Criteria:

  • Individuals ≥ 18 years of age.
  • Adult kidney transplant recipients awaiting transplant, kidney transplant recipients and living kidney donors.


Exclusion Criteria:

  • Subjects under 18 years of age.

Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.

 

 

 

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Undiagnosed Tumor/Undifferentiated Mass Registry (Undiagnosed Tumor/Undifferentiated Mass Registry)

Undiagnosed Tumor/Undifferentiated Mass Registry

Elizabeth Gilman
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305704-P01-RST
21-008859
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Inclusion Criteria:
  

  • Patient presenting to a General Internal Medicine Service.
  • Patient in one of the 3 Mayo Clinic Campuses (Rochester, Arizona, Florida).
  • Patient with an undiagnosed mass: New or enlarging lymph nodes clinically or on imaging:
    • New mass on imaging of soft tissues, bone, spleen, adrenal gland, retroperitoneum, or intraabdominal location without clear organ association .
  • Patient has understood and signed the informed consent to participate in the registry.
  • Patient has the ability to complete all aspects of registry enrollment.
  • Aged 18 and older.

 


Exclusion Criteria:
   

  • Mass involving the breast, brain, kidney, lung, ovary/adnexa, liver, pancreas, sinus, throat, or thyroid gland will be addressed by the respective specialty areas.  
  • Patients with a known history of any condition or factor judged by the investigator to preclude participation in the registry or which might hinder adherence.
  • Lacking the capacity to consent.
  • Prisoners or institutionalized individuals.
  • Pregnant women.

Eligibility last updated 9/17/21. Questions regarding updates should be directed to the study team contact.

 

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The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population (Pathfinder 2)

PATHFINDER 2: A Multi-Cancer Early Detection Study

Karthik Giridhar
All
50 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305712-P01-RST
21-009209
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Inclusion Criteria:


1. Participants must be at least 50 years of age, inclusive, at the time of signing the
Informed Consent Form (ICF).

2. Participants must be capable of giving signed and legally effective informed consent


Exclusion Criteria:


1. Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer
(e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the
basis of a suspicious imaging abnormality).

2. Personal history of invasive solid tumor or hematologic malignancy, diagnosed within
the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior
to expected enrollment date and never treated.

- Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous
cell carcinoma of the skin are not excluded.

3. Prior/Concurrent Concomitant Therapy (Medications/Treatments):

- Definitive treatment for invasive solid tumor or hematologic malignancy within
the 3 years prior to expected enrollment date. Adjuvant hormone therapy for
cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.

4. Individuals who will not be able to comply with the protocol procedures.

5. Individuals who are not currently registered patients at a participating center.

6. Previous or current participation in another GRAIL-sponsored study. "Participation" is
defined as having signed consent and provided a blood sample.

7. Previous or current employees or contractors of GRAIL.

8. Current pregnancy (by self-report of pregnancy status)

Eligibility last updated6/7/22. Questions regarding updates should be directed to the study team contact.

Diagnostic Test, Device
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Clinical Utility of Eosinophil-Derived Neurotoxin (EDN) in Asthma Diagnosis and Evaluation (EDN)

Eosinophil/Asthma Study

Melissa Snyder
All
1 years and over
This study is NOT accepting healthy volunteers
2021-305715-H01-RST
21-008894
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Inclusion Criteria
•Study Arm 1 Preschool Children < 6 years old 
Asthma Group (N=200) :

  • Diagnosis of asthma.
  • In the absence of an asthma diagnosis:
    • Persistent wheezing of at least one year;
    • Even distribution of socio-demographics including age, gender, race and ethnicity.


Exclusion Criteria:

  • Actively sick with covid or flu.

Inclusion Criteria
•Non-Asthma/Disease Controls (N=200)
 :

  • Diagnosis of allergy.
  • Even distribution of sociodemographics including age, gender, race and ethnicity.


Exclusion Criteria:

  • Diagnosis of asthma.
  • Recurrent wheezing.
  • Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls (N=200)
 

  • Not having or suspected of having any known upper/lower respiratory disease.
  • Even distribution of sociodemographics including age, gender, race and ethnicity.


Exclusion Criteria:

  • Diagnosis of asthma or any known upper/lower respiratory disease.
  • Diagnosis of allergy.
  • Actively sick with covid or flu.

Inclusion Criteria
•Study Arm 2 Children 6-17 years of age 
Asthma Group (N=200) :

  • Diagnosis of asthma.
  • In the absence of an asthma diagnosis:
    • Persistent wheezing of at least one year.
  • Even distribution of sociodemographics including age, gender, race and ethnicity.


Exclusion Criteria:

  • Actively sick with covid or flu.  

Inclusion Criteria
•Non-Asthma/Disease Controls  (N=200)
 :

  • Diagnosis of allergy. 
  • Even distribution of sociodemographics including age, gender, race and ethnicity.


Exclusion Criteria:
 

  • Diagnosis of asthma.
  • Recurrent wheezing.
  • Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls  (N=200)
 :

  •  Not having or suspected of having any known upper/lower respiratory disease.
  • Even distribution of sociodemographics including age, gender, race and ethnicity. 


Exclusion Criteria:
 

  • Diagnosis of asthma or recurrent wheezing.
  • Diagnosis of allergy.
  • Actively sick with covid or flu.

Inclusion Criteria
•Study Arm 3  Adults > 18 years old
Asthma Group (N=200)
 :

  • Diagnosis of asthma.
  • Even distribution of sociodemographics including age, gender, race and ethnicity. 


Exclusion Criteria:
 

  • Actively sick with covid or flu.  

Inclusion Criteria
•Non-Asthma/Disease Controls (N=200)
 :

  • Diagnosis of allergy.
  • Even distribution of sociodemographics including age, gender, race and ethnicity. 


Exclusion Criteria:

  • Diagnosis of asthma.
  • Recurrent wheezing.
  • Actively sick with covid or flu.

Inclusion Criteria
•Healthy Controls  (N=200)
 :

  •  Not having or suspected of having any known upper/lower respiratory disease.
  • Even distribution of socio-demographics including age, gender, race and ethnicity.

Exclusion Criteriao: 

  • Diagnosis of asthma.
  • Diagnosis of allergy.
  • Actively sick with covid or flu.

Eligibility last updated 11/2/22. Questions regarding updates should be directed to the study team contact.

 

 

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A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) (TPN-101)

A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD

Bradley Boeve
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305733-P01-RST
21-009164
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Inclusion Criteria:


- Have documentation of a clinical genetic test demonstrating the presence of a
confirmed repeat expansion in the C9orf72 gene from a CLIA certified laboratory

- Score ≥ 18 on the Mini-Mental State Exam (MMSE) at Screening

- Have a reliable caregiver to accompany the patient to all study visits.

- For patients with ALS (with or without FTD):

- Diagnosis of ALS (probable, possible, laboratory-supported probable or definite)
according to the World Federation of Neurology revised E1 Escorial criteria

- Onset of weakness within 3 years prior to Screening

- Slow vital capacity (SVC) ≥ 60% of predicted normal adjusted for sex, age, and
height (from the sitting position)

- ALS Functional Rating Scale-Revised (ALSFRS-R) ≥ 30 at Screening

- For patients with FTD:

- A gradual, progressive decline in behavior, language, or motor function
consistent with C9ORF72 hexanucleotide expansion-related syndrome such as
behavioral variant FTD, primary progressive vaphasia, or amnestic syndrome

- CDR Dementia Staging Instrument plus National Alzheimer's Coordinating Center
Behavior and Language Domains (CDR plus NACC FTLD) global score of 0.5-2.0 at
Screening


Exclusion Criteria:


- Presence of other significant neurological or psychiatric disorders

- History of significant brain abnormality, including, but not limited to, prior
hemorrhage or infarct, cerebral contusion, encephalomalacia, aneurysm, vascular
malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abscess
or brain tumor such as meningioma); symptoms or signs of elevated intracranial
pressure, e.g., symptoms or history of head injury or abnormal funduscopic exam. If
there is history or evidence on neurologic exam suggesting possible subdural hematoma
(SDH), patients should be fully evaluated, including magnetic resonance imaging (MRI)
if indicated, to exclude significant, new SDH

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Control-IQ Technology in Individuals with Type 2 Diabetes (2IQ) (2IQ)

Control-IQ Technology in Individuals with Type 2 Diabetes

Yogish Kudva
All
18 years and over
Feasibility
This study is NOT accepting healthy volunteers
2021-306321-P01-RST
21-011266
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Inclusion Criteria:

  • Age ≥ 18 years old and residing in the US.
  • Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year.
  • Using a stable insulin dose for at least 3 months, to include A) basal insulin only, or B) MDI, to include CSII (including use of AID systems other than Tandem Control-IQ).
  • Total daily insulin dose ≤ 200 units/day.
  • Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin.
  • For females, not currently known to be pregnant If female of childbearing potential, must agree to use a form of contraception to prevent pregnancy while a participant in the study as documented in the study records. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  • HbA1c ≥ 7.5% and ≤ 12% at screening.
  • Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one).
  • Be willing to exercise for 30 minutes or more at least once per week during the main phase of the study.
  • Has the ability to read and understand written English.
  • Investigator believes that the participant has capacity such that they can provide informed consent and can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study.


Exclusion Criteria:

  • Prior use of Tandem t:slim X2 insulin pump with Control-IQ technology.
  • Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months.
  • History of inpatient psychiatric treatment in the past 6 months.
  • History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study.
  • History of significant heart disease, lung disease, liver disease, chronic kidney disease, or other systemic disease determined by investigator to interfere with the study, or make required exercise unsafe.
  • History of significant vision, hearing, or dexterity problems that will impair use of the closed loop system.
  • Use of glucocorticoids, beta blockers, sulfonylureas, meglitinides or other medications specifically listed in section 8.3 of the protocol or determined by investigator to interfere with the study.
  • Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or other adjuvant medication or starting a new glucose lowering agent during the trial.
  • Unstable dose of any medication used for weight loss or starting a new medication for weight loss during the trial. 
  • Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (> 450 ms).
  • History of hemodialysis.
  • History of adrenal insufficiency.
  • Uncontrolled hypo- or hyperthyroidism.
  • Significant diabetes related complications, based on investigator assessment.
  • Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.

Eligibility last updated 10/26/21. Questions regarding updates should be directed to the study team contact.

 

 

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Clopidogrel Monotherapy in High Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions: A Safety Assessment, Pilot Study to Reduce Post-Discharge Bleeding (CHAMP)

Clopidogrel Monotherapy After PCI in Patients with High Bleeding Risk

Mandeep Singh
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306326-H01-RST
21-011053
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Inclusion Criteria:


- Informed consent in adults

- Successful percutaneous coronary intervention (PCI) [no non-fatal MI/stroke/repeat
target revascularization/bleeding/acute kidney injury].

- Academic research consortium-high bleeding risk (ARC-HBR) score ≥ 4.


Exclusion Criteria:


- Chronic use of warfarin or direct oral anticoagulant (DOAC).

- Unsuccessful PCI (see above).

- Lesions with angiographic thrombus.

- Prior PCI within 6 months.

- Planned PCI or surgical intervention to treat any cardiac or noncardiac condition
within 6 months.

- High risk lesion/stent characteristics (> 50% unprotected left main disease,
bifurcation disease requiring 2 stents technique, rotational atherectomy.

- Vein graft.

- Unprotected left main intervention or history of definite stent thrombosis.

- Women of child-bearing age unless negative pregnancy test is done.

- Life expectancy < 1 year.

- Known drug/alcohol dependence.

- Assessment that the patient will not be compliant with the study protocol.

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Muscle Oxygen Transport Measured with Near-infrared Spectroscopy (NIRS): A Comparison of NIRS Technologies for Experimental and Clinical Applications

NIRS - Minimal Risk

Michael Joyner
All
18 years to 45 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306336-H01-RST
21-011252
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Inclusion Criteria:

  • Healthy adults between the ages of 18 and 45.


Exclusion Criteria:

  • Individuals < 18 or > 45 years of age.
  • Pregnant women (testing will be done by research team if requested).
  • History of pulmonary, neurologic, cardiovascular, or musculoskeletal diseases.

Eligibility last updated 10/26/21. Questions regarding updates should be directed to the study team contact.

 

 

 

Behavioral
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