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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.

3658 Study Matches

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Adrenoleukodystrophy National Registry Study

In this protocol, we will enroll pediatric, adolescent and adult patients diagnosed with adrenoleukodystrophy (ALD). These patients will include probands diagnosed by newborn screening and their relatives subsequently diagnosed, as well other patients who are diagnosed with ALD due to other presenting signs and symptoms and subsequently were confirmed to have ALD. We will ask consenting subjects to provide a medical history (with verification via medical records), to participate in a semi-annual health survey and provide consent to collect biospecimens. The overarching goal of this work is to engage with families affected by ALD and to assemble a resource of clinical, medical, and biological data that will allow of to better understand the natural history of ALD, and how this is affected by newborn screening. The initial focus will be on patients within Minnesota, but participation will be open to any family interested in the study, as this will be web-based. This registry and biobank, together with other research conducted in tandem, will possibly provide information describing the natural history of ALD and outcomes with interventions. It is anticipated that the data collected will further our understanding of the natural history of the disease, basic biology of adrenoleukodystrophy, diagnosis and outcomes. Ultimately, this research may lead to new avenues for early diagnosis and development of safer and more effective therapies for ALD.

Ashish Gupta
gupta461@umn.edu
All
Not specified
This study is NOT accepting healthy volunteers
NCT03789721
STUDY00003605
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Inclusion Criteria
• Age 0
•100
• ALD patients or family member meeting any of the following criteria:
• Any patient diagnosed with ALD (confirmed by positive VLCFA testing and/or genetic mutation).
• Known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene
• Participants living in the United States and territories Exclusion Criteria
• Patients diagnosed with ALD who lack the capacity to consent/assent AND do not have a designated legally authorized representative or guardian.
• Patients who have undergone BMT or other cellular therapy .
• Patients not fluent in English who are unable to consent in-person at the BMT Journey Clinic.
• Patients who are illiterate
• Patient determined by the PI or designee to be unlikely to complete required study components (due to language barriers, compliance issues, etc.)
Other: Medical Record Abstraction, Other: Biospecimen Sample Collection
ALD (Adrenoleukodystrophy), Adrenoleukodystrophy, Cerebral Adrenoleukodystrophy
Registry, VLCFA, ABCD1, X-chromosome
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Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota Phil Lacher - (placher@umn.edu)

ACCL2031, A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine (IND #149832) for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors (ACCL2031)

A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor

Nadia Laack
All
4 years to 17 years old
Phase 3
This study is NOT accepting healthy volunteers
2020-302527-P01-RST
20-010883
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Inclusion Criteria:


- >= 4 and < 18 years at time of study entry

- Patients must weigh 15 kg or greater at time of study entry

- Newly diagnosed or recurrent primary brain tumors that have not received prior cranial
radiotherapy

- Planned focal, cranial or craniospinal radiation treatment for a primary brain tumor

- The patient must have receptive and expressive language skills in English, French or
Spanish since the neurocognitive function and quality of life (QOL) assessment
instruments are available in these languages only

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

- Age: 4 to < 6 years; Maximum serum creatinine (mg/dL): 0.8 male; 0.8 female

- Age: 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 male; 1 female

- Age: 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 male; 1.2 female

- Age: 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 male; 1.4 female

- Age: >= 16 years; Maximum serum creatinine (mg/dL): 1.7 male; 1.4 female

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135
U/L

- Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the
value of 45 U/L

- The patient must be able to undergo magnetic resonance imaging

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

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


Exclusion Criteria:


- Life expectancy of less than 18 months

- Pre-existing conditions:

- Any contraindication or allergy to memantine

- Intractable seizures while on adequate anticonvulsant therapy, defined as more
than one seizure per month for the past 2 months or since initiating
anticonvulsant therapy

- Co-morbid systemic illnesses, psychiatric conditions, social situations, or other
severe concurrent disease which, in the judgment of the investigator, would make
the patient inappropriate for entry into this study or interfere significantly
with the proper assessment of safety and toxicity of the prescribed regimens or
would limit compliance with the study requirements

- Patients with a motor, visual, or auditory condition that precludes computerized
neurocognitive assessments are not eligible to participate

- Patients with any medical condition or taking medications that lead to
alterations of urine pH towards the alkaline condition (e.g., renal tubular
acidosis, carbonic anhydrase inhibitors, sodium bicarbonate)

- Personal history of prior cranial or craniospinal radiotherapy is not allowed

- Note: Prior anti-cancer therapy including surgery, chemotherapy, targeted agents
are allowed as per standard of care clinical treatment guidelines

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

- Lactating females who plan to breastfeed their infants

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

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

Ventricular and Vascular Function Abnormalities in Patients with Coarctation of Aorta: The Role of Exercise Echocardiography

A Study to Analyze if Exercise Echocardiography Can Identify Ventricular and Vascular Function Abnormalities That are Undetectable at Rest for Patients With Coarctation of Aorta (COA)

Alexander Egbe
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-120334-H01-RST
17-010089
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • History of COA.


Exclusion Criteria:

  • Patients under 18 years old.

 

Other, Radiation, Exercise stress echocardiography
Coarctation of the aorta
Cardiovascular system, Coarctation of aorta, Exercise stress test
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Mayo Clinic — Rochester, MN

A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)

Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

Matthew Starr
All
50 years to 89 years old
Phase 3
This study is NOT accepting healthy volunteers
2022-309398-P01-RST
22-009439
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Inclusion Criteria:


1. Age ≥ 50 years and ≤ 89 years

2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye

3. Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with
anti-VEGF

4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.

5. Willing and able to provide written, signed informed consent for this study

6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at
study entry


Exclusion Criteria:


1. CNV or macular edema in the study eye secondary to any causes other than AMD

In the study eye since randomization,
new retinal detachment, or retinal tear
that, in the opinion of the investigator,
may preclude successful subretinal
injection of ABBV-RGX-314.

New subfoveal fibrosis or subfoveal atrophy since randomization, as defined in subbullets below, or any condition preventing VA improvement in the study eye.
•Central subfield fibrosis (central 1mm) in the study eye, as determined by the CRC.
•Any central subfield atrophy (central 1mm) in the study eye (eg, incomplete RPE and outer retinal atrophy, or complete RPE and outer retinal atrophy), as determined by the CRC.

3. Ocular or periocular infection or intraocular inflammation in the study eye that may interfere with the surgical procedure.

4. Myocardial infarction, cerebrovascular accident, or transient ischemic attacks since randomization.

5. Uncontrolled hypertension (systolic BP >180 mmHg, diastolic BP > 100 mmHg) despite maximal medical treatment.

History of malignancy or hematologic malignancy that may compromise the immune system requiring chemotherapy and/or radiation since randomization. Localized basal cell carcinoma will be permitted, as will any cancer not being treated with chemotherapy or other therapy that may compromise the immune system.

Polypoidal choroidal vasculopathy in the study eye, as determined by the investigator or the CRC.

7. Any subretinal hemorrhage in the study eye > 50% of the total lesion area or within the parafovea (3-mm center of the macula), as determined by the CRC.

8. Presence of any retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye, as determined by the CRC.

9. Any prior nAMD treatment with photodynamic therapy or retinal laser in the study eye.

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

Eligibility last updated 10/25/23. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Genetic
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Mayo Clinic — Rochester, MN

A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ATMOSPHERE) (ATMOSPHERE)

A Study to Evaluate Gene Therapy to Treat Neovascular Age-related Macular Degeneration

Sophie Bakri
All
50 years to 89 years old
Phase 2/3
This study is NOT accepting healthy volunteers
2021-304212-P01-RST
21-003698
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Inclusion Criteria:

  • Males or females, aged ≥ 50 years and ≤ 89 years.
  • An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye at Screening Visit 1.
  • If both eyes are eligible, the study eye must be the participant’s worse-seeing eye, as determined by the investigator prior to randomization.
  • Must have a diagnosis of subfoveal CNV secondary to AMD in the study eye, along with fluid within the parafovea (3-mm center of the macula, based on the early treatment diabetic retinopathy grid) at Screening Visit 1.
    • CNV lesion characteristics as assessed by the CRC: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm^2).
  • Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
  • Must be willing and able to comply with all study procedures and be available for the duration of the study.
  • Women must be postmenopausal (defined as being at least 12 consecutive months without menses) or surgically sterilized (ie, having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy).
  • Male participants engaged in a sexual relationship with a woman of childbearing potential must be willing to use condoms (and their partners to use a medically accepted method of contraception) from the day of RGX-314 administration until 4 weeks after RGX-314 administration.
  • Must be willing and able to provide written, signed informed consent.
  • Response criteria: Based on the Screening Visit 2 SD-OCT, participants must have improvement in fluid of > 50 μm or, if the participant has < 50 μm of fluid, then any improvement in fluid and have a CRT < 400 μm at the screening visit, as determined by the CRC. Note that, if the participant has disease other than fluid contributing to an increase (i.e., pigment epithelial detachment [PED] or subretinal hyper-reflective material [SHRM]) in CRT, they will be enrolled if they have < 50 μm of fluid (intraretinal or subretinal), as determined by the CRC.
  • Additionally, participants who received 10 to 12 anti-VEGF injections in the study eye in the 12 months prior to Screening Visit 1 must demonstrate a complete fluid response as determined by CRC review of the Screening Visit 2 SD-OCT, defined as complete resolution of fluid.


Exclusion Criteria:

  • CNV or macular edema in the study eye secondary to any causes other than AMD.
  • Subfoveal fibrosis or atrophy as determined by the CRC.
  • Study eye that required > 12 anti-VEGF injections in the 12 months prior to the Screening Visit
  • Any condition in the investigator’s opinion that could limit VA improvement in the study eye.
  • Active or history of retinal detachment in the study eye.
  • Advanced glaucoma in the study eye defined as IOP of > 23 mmHg not controlled by 2 IOP-lowering medications or any invasive procedure to treat glaucoma (e.g., shunt, tube, or minimally invasive glaucoma surgery [MIGS] devices; selective laser trabeculectomy, and argon laser trabeculoplasty are permitted).
  • Study eye with nAMD diagnosed > 4 years from Screening Visit 1.
  • Any condition in the study eye that, in the opinion of the investigator, may increase the risk to the participant, require either medical or surgical intervention during the course of the study to prevent or treat vision loss, or interfere with study procedures or assessments.
  • History of intraocular surgery in the study eye within 12 weeks prior to Screening Visit 1. Yttrium aluminum garnet capsulotomy is permitted if performed > 10 weeks prior to the Screening Visit 1.
  • History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1.
  • Presence of any implant in the study eye at Screening Visit 1 (excluding intraocular lens or MIGS).
  • History of malignancy or hematologic malignancy that may compromise the immune system requiring chemotherapy and/or radiation in the 5 years prior to Screening Visit 1. Localized basal cell carcinoma will be permitted.
  • Receipt of any investigational product within the 30 days of enrollment or 5 half-lives of the investigational product, whichever is longer.
  • Received gene therapy.
  • History of retinal toxicity caused by a therapy that may affect VA, eg, chloroquine or hydroxychloroquine.
  • Ocular or periocular infection in the study eye that may interfere with the surgical procedure.
  • Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
  • Uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg, diastolic BP > 100 mmHg) despite maximal medical treatment.
  • Any participant with the following laboratory values at Screening Visit 1 will be withdrawn from study:
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN);
    • Total bilirubin > 1.5 × ULN, unless the participant has a previously known history of Gilbert’s syndrome and a fractionated bilirubin that shows conjugated bilirubin < 35% of total bilirubin;
    • Prothrombin time > 1.5 × ULN, unless the participant is anticoagulated:
      • Participants who are anticoagulated will be monitored by local labs and managed per local practice to hold or bridge anticoagulant therapy for the study procedure; consultation with the Medical Monitor is also required;
    • Hemoglobin < 10 g/dL for male participants and < 9 g/dL for female participants;
    • Platelets < 100 × 10^3/μL;
    • Estimated glomerular filtration rate < 30 mL/min/1.73 m^2.
  • Currently taking anticoagulation therapy for which holding anticoagulation therapy for RGX-314 administration is not indicated or considered to be unsafe in the opinion of the treating investigator (i.e., retinal surgeon), as well as the physician prescribing anticoagulation for the participant.
  • Any concomitant treatment that, in the opinion of the investigator, may interfere with ocular surgical procedure or healing process.
  • Known hypersensitivity to ranibizumab or any of its components.
  • Has a serious, chronic, or unstable medical or psychological condition that, in the opinion of the investigator or Sponsor, may compromise the participant’s safety or ability to complete all assessments and follow-up in the study.
  • Prior corneal transplant in the study eye.
  • Pigmentary glaucoma in the study eye.

Inclusion Criteria for Participants in the Control Arm Who Cross Over to RGX-314 Treatment After Week 54:

  • Study eye will be the eye that qualified at randomization.
  • Study eye has a CRT < 400 μm of fluid or (in cases where a participant may have nonfluid elevation in the CRT, eg, pigment epithelial defect) < 50 μm of excess fluid, as confirmed by the masked CRC.
  • Male participants engaged in a sexual relationship with a woman of childbearing potential must be willing to use condoms (and their partners to use a medically accepted method of contraception) from the day of RGX-314 administration until 4 weeks after RGX-314 administration.


Exclusion Criteria:

  • CNV or macular edema in the study eye secondary to any causes other than AMD.
  • New subfoveal fibrosis or atrophy since randomization, as determined by the CRC, or any condition preventing VA improvement in the study eye.
  • Ocular or periocular infection in the study eye that may interfere with the surgical procedure.
  • Myocardial infarction, cerebrovascular accident, or transient ischemic attacks since randomization.
  • Uncontrolled hypertension (systolic BP > 180 mmHg, diastolic BP > 100 mmHg) despite maximal medical treatment.
  • Any concomitant treatment that, in the opinion of the investigator, may interfere with ocular surgical procedure or healing process.
  • History of malignancy or hematologic malignancy that may compromise the immune system requiring chemotherapy and/or radiation since randomization. Localized basal cell carcinoma will be permitted.
  • Currently taking anticoagulation therapy for which holding anticoagulation therapy for RGX-314 administration is not indicated or considered to be unsafe in the opinion of the treating investigator as well as the physician prescribing anticoagulation for the participant.

Eligibility last updated 10/27/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Genetic
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Mayo Clinic — Rochester, MN

A Phase I Study Evaluating the Safety of Intra-Articular Sc-rAAV2.5IL-1Ra in Subjects With Moderate Osteoarthritis of the Knee (AAVIL-1Ra)

A Study of the Safety of Joint Injected Sc-rAAV2.5IL-1Ra (a Virus Carried Gene Therapy) in Patients with Moderate Knee Osteoarthritis

Christopher Evans
All
18 years to 80 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-117977-P01-RST
15-007542
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Inclusion Criteria:

  • Age 18-80 years old.
  • Gender: both males and females.
  • Target disease: Moderate OA of the knee.
  • Persistent symptoms, despite standard NSAID.
  • Absence of clinically significant abnormal values for the following:
    • Complete blood count;
    • Prothrombin Time, Activated partial thromboplastin time;
    • Blood chemistry (Glucose, Na, K, Cl, CO2, BUN, creatinine, Ca, PO4, magnesium, uric acid);
    • Liver function tests (amylase, total bilirubin, alkaline phosphate, GGT, AST, ALT, total protein, albumin).
  • Able and willing to return to the Mayo Clinic for follow-up visits, as required by this study.
  • Able undergo MRI of the knee.
  • Subjects should be able to give appropriate consent.
  • Potential subjects should have failed a three-month trial of a minimum of two conservative therapies before being considered for this trial. These conservative therapies include: activity modification, weight loss, physical therapy, and anti-inflammatory or injection therapy.


Exclusion Criteria:

  • Pregnant, or currently breast-feeding.
  • Ongoing infectious disease including HIV, HTLV, hepatitis, syphilis or tuberculosis positive.
  • Individuals who have OA as part of another syndrome (e.g. Ehler’s Danlos, Stickler syndrome, etc.).
  • Systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
  • Clinically significant cardiovascular, renal, hepatic, endocrine disease, diabetes, cancer, autoimmune diseases; a serious infection or major operation within 30 days of enrollment; a history of untreated psychiatric disease or recent history of alcoholism or drug addiction.
  • Currently taking immunosuppressant medications.
  • Anticipated major surgery during the study period.
  • Individuals involved in another interventional protocol, or have been treated under one within the last 3 months.
  • Intra-articular therapy in the index knee within the previous 3 months.
  • Surgery to the target knee within 6 months prior to screening.
  • Surgery to other weight bearing joints if it will interfere with knee assessments.
  • Prior articular transplant procedures.
  • Orthopedic hardware or implantable devices anywhere in the body, other than dental.
  • Prior reconstruction surgery to the target knee within 12 months.
  • X-ray findings of acute fractures.
  • Known severe loss of bone density, and/or severe bone or joint deformity in the target knee.
  • Significant target knee infection or overlying skin disorder/infection within the previous 6 months prior to study enrollment.
  • Require cane or other assistive device for walking.
  • Symptomatic OA of the hips, spine or ankle if it would interfere with the evaluation of the target knee.
  • History of documented nerve damage in the affected limb, or vascular insufficiency.
  • Condition requiring use of systemic steroids.
  • Coagulation disorder.
  • Patients with unstable knees.
  • Temperature above 99.5° F.
  • Identification as a member of a vulnerable population.
  • BMI greater than 40.
  • History of allergy to local anesthetics.
  • Currently taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to entry in the study.
  • Any illness or condition which, in the investigators’ judgement will interfere with the patient’s ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.

 

Genetic, Gene therapy
Osteoarthritis
Gene therapy, Musculoskeletal system, Osteoarthritis of knee, Regenerative medicine therapy
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A Prospective, Multi‐Center Study of the Medtronic Braive™ Growth Modulation System When Used in the Treatment of Pediatric Patients Diagnosed with Juvenile or Adolescent Idiopathic Scoliosis (BRAIVE IDE Study) (BRAIVE IDE)

Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis (BRAIVE IDE)

Annalise Larson
All
9 years to 16 years old
This study is NOT accepting healthy volunteers
2021-305386-P01-RST
21-007823
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Inclusion Criteria:

  • Has a diagnosis of juvenile or adolescent idiopathic scoliosis.
  • Is skeletally immature with a Sanders Score of ≥ 2 to ≤ 5.
  • Has failed conservative care as per investigator’s assessment.
  • Has a main thoracic Cobb angle between 30 and 60 degrees.
  • Has a Lenke Classification of 1A, 1B, or 1C.
  • Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative.
  • Informed Consent Form/Assent and Authorization to Use and Disclose Health Information (if applicable) have been signed by parent/legal guardian and/or patient/participant per local requirement.


Exclusion Criteria:

  • Has undergone previous spinal fusion procedure(s) at the affected levels.
  • Is pregnant or plans to become pregnant within the first 24‐months of the study.
  • Has a curve that requires instrumentation below L1.
  • Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord).
  • Has any type of non‐idiopathic scoliosis.
  • Has a left‐sided curve.
  • Has an associated syndrome.
  • Has a history of malignant hyperthermia.
  • Has an active or significant risk of infection (immunocompromised).
  • Has inadequate tissue coverage over the operative site as per investigator’s assessment.
  • Has a suspected or documented allergy or intolerance to implant materials.
  • Has a major psychiatric disorder/ history of drug abuse that would interfere with the subject’s ability to comply with study instructions or might confound the study interpretation as per investigator’s assessment (DSM‐5 can be used as a reference).
  • Is a ward of the court/state.
  • Has had prior ipsilateral or contralateral chest surgery.
  • Has severe chronic lung disease (e.g., asthma, bronchiectasis).
  • Has poor bone quality, as determined by the investigator, that may limit anterior fixation.
  • Is unwilling or unable to return for follow‐up visits and/or follow intra‐operative and/or postoperative instructions.
  • Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*.
  • Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic’s study manager to determine if the subject can be enrolled in the BRAIVE IDE Study.

*Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic’s study manager to determine if the subject can be enrolled in the BRAIVE IDE Study. 

Eligibility last updated 11/16/21. 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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Mayo Clinic — Rochester, MN

Study of Safety, Tolerability and Efficacy of PBGM01 in Pediatric Subjects With GM1 Gangliosidosis (Imagine-1)

This study is a prospective multi-cohort, open-label, dose-escalation assessment of the safety and efficayc of PBGM01, an AAVHu68, intra-cisternal magna delivered gene therapy for the treatment of GM1 gangliosidosis in infants 1-24 months of age.

All
4 Months to 36 Months old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04713475
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Inclusion Criteria:

• All Patients: Documented GM1 gangliosidosis diagnosis based on genotyping confirming 2 mutations in the GLB1 gene and documented deficiency of beta-galactosidase enzyme by laboratory testing
• Age: 4 to 36 months (first cohort will be 12-36 months) Subjects:
• Early onset infantile (Type 1): Subjects who have signs and/or symptoms of GM1 gangliosidosis that started at or before 6 months of age and have specific developmental milestones remaining
• Late onset infantile (Type 2a): Subjects who have signs and/or symptoms of GM1 gangliosidosis that started between 6 and 18 months of age and have specific developmental milestones remaining
Exclusion Criteria:
1. Any clinically significant neurocognitive deficit not attributable to GM1 gangliosidosis or any other condition that may, in the opinion of the investigator, confound interpretation of study results. 2. If a subject had an acute illness requiring hospitalization within 30 days of enrollment, the history must be discussed with the sponsor's medical monitor before allowing the subject to be enrolled. 3. History of ventilation assisted respiratory support or a need for tracheostomy as a result of their disease. 4. Intractable seizure or uncontrolled epilepsy defined as having had an episode of status epilepticus, or seizures requiring hospitalization within 30 days prior to dosing of PBGM01. 5. Any contraindication to the ICM administration procedure, including contraindications to fluoroscopic imaging and anesthesia or any condition that would increase the risk of adverse outcomes from the ICM procedure including, but not limited to, the presence of a space occupying lesion causing mass effects or signs of increased intracranial pressure, space occupying lesion in the posterior fossa or foramen magnum, aberrant vascular anatomy such as a large midline posterior inferior cerebellar artery, aberrant venous anatomy such as a large cerebellar vein or occipital sinus, or congenital anatomical abnormalities such as a Chiari malformation. 6. Any contraindication to MRI or lumbar puncture (LP). 7. Prior gene therapy. 8. Use of miglustat within 48 hours prior to dosing of PBGM01. The use of miglustat is prohibited throughout the study. 9. Use of enzyme replacement therapy or other investigational therapy within 5 half-lives prior to dosing of PBGM01. The use of enzyme replacement is prohibited throughout the study. 10. Receipt of a vaccine within 14 days of dosing. 11. Estimate glomerular filtration rate (eGFR) <30 mL/minute based on creatinine 12. Coagulopathy (INR > 1.5) or activated partial thromboplastin time [aPTT] > 40 seconds 13. Thrombocytopenia (platelet count < 100,000 per μL. 14. AST or ALT > 3 times the upper limit of normal (ULN) or total bilirubin > 1.5x ULN 15. Cardiomyopathy (screening troponin level above the ULN). 16. Peripheral neuropathy 17. Medical conditions or laboratory or vital sign abnormalities that would increase risk of complications from intra-cisterna magna injection, anesthesia, fluoroscopy, LP, and/or MRI including temperature over 38°C, oxygen saturation below 95% on room air or baseline oxygen requirement, heart rate or respiratory rate abnormal for age of the subject, abnormal blood pressure for age, or evidence of infection. 18. Any condition (e.g., history of any disease, evidence of any current disease, any finding upon physical examination, or any laboratory abnormality) that, in the opinion of the investigator, would put the subject at undue risk during the administration procedure or would interfere with evaluation of PBGM01 or interpretation of subject safety or study results.
Biological: PBGM01
GM1 Gangliosidosis, GM1 Gangliosidosis, Type I, GM1 Gangliosidosis, Type 2, Beta-Galactosidase-1 (GLB1) Deficiency
Infantile, Late Infantile, Rare disease, Lysosomal storage disease
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University of Minnesota — Minneapolis, Minnesota

TrAstuzumab Cardiomyopathy Therapeutic Intervention with Carvedilol (TACTIC) Trial (TACTIC)

Treating Breast Cancer Patients Undergoing Trastuzumab Treatment with Carvedilol to Reduce Incidence of Heart Failure

Joerg Herrmann
Female
18 years and over
Phase 2, Post Market
This study is NOT accepting healthy volunteers
0000-101043-P01-RST
18-006090
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Inclusion Criteria:

  • ≥ 18 years of age.
  • New or locally recurrent diagnosis of HER2+ breast cancer that will be treated with curative intent.
  • Planned HER2-directed therapy (any therapy targeting HER2 signaling including trastuzumab +/- pertuzumab or trastuzumab-emtansine (T-DM1)). Neratinib and lapatinib will not be considered “Her2-directed therapy” or “anti-HER2” for the purpose of this study.


Exclusion Criteria:

  • Metastatic breast cancer (distant metastases).
  • Active systemic treatment for non-breast cancer.
  • History of HF of any class and type, or diagnosis of cardiomyopathy in the past, LVEF < 50% at screening, intolerance to beta-blocker, baseline use of any beta-blocker for coronary artery disease including myocardial infarction, current ACE inhibitor or ARB therapy for hypertension in the presence of diabetes and/or for chronic kidney disease/proteinuria, on active therapy with amiodarone, sotalol, or any other antiarrhythmic history of bronchial asthma or related  bronchospastic conditions, heart rate < 50 BPM at screening (average of 3 most recent readings).
  • History of or current sick sinus syndrome.
  • AV block grade II or higher (unless patient has a permanent pacemaker) at screening.
  • Systolic blood pressure < 90 mmHg at screening (average of 3 most recent readings).
  • Severe hepatic dysfunction, as defined by NCI ODWG (total bilirubin > 3x ULN with any AST elevation) or Child Pugh C class.
  • Pregnancy.
Device, Drug, Administration of antineoplastic agent, Drug therapy, Primary prevention of cardiovascular disease
Breast cancer, Cancer, Heart failure
Cancer treatment, Cardiovascular disease prevention, Cardiovascular system, Chemotherapy, Chemotherapy for breast cancer, HER2-positive carcinoma of breast, Heart failure as a complication of care, Medical Oncology, carvedilol, trastuzumab
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Mayo Clinic — Rochester, MN

A Phase 1/2 Study of the Safety and Efficacy of LX2006 Gene Therapy in Participants with Cardiomyopathy Associated with Friedreich’s Ataxia

Gene Therapy for Cardiomyopathy Associated With Friedreich's Ataxia

Ralitza Gavrilova
All
18 years to 40 years old
Phase 1/2
This study is NOT accepting healthy volunteers
2022-307601-P01-RST
22-003052
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Inclusion Criteria:

  • Confirmed genetic diagnosis of Friedreich’s Ataxia (FA), with onset being before 25 years of age.
  • Protocol specified ranges for antibodies.
  • Protocol specified measures of FA cardiomyopathy.


Exclusion Criteria:

  • Protocol specified ranges for left ventricular ejection fraction (LVEF) as measured by cardiac ECHO.
  • Uncontrolled diabetes.
  • Abnormal liver function.
  • Active infection of any type, including hepatitis virus (A, B or C) or human immunodeficiency virus (HIV-1 and HIV-2).
  • Contraindication to cardiac MRI.
  • Contraindications to cardiac biopsies.
  • Participants who are receiving systemic corticosteroids or other immunosuppressive medications.
  • History of significant coronary artery disease or any structural heart or vascular disease other than FA cardiomyopathy.
  • Presence of clinically significant, hemodynamically unstable arrhythmias, requiring physician intervention.
  • Presence of clinically significant abnormalities as determined by the investigator, other than ECG abnormalities related to FA.
  • Uncontrolled psychiatric disease.

Other Inclusion/Exclusion Criteria to be applied as per protocol.

Eligibility last updated 7/13/23. Questions regarding updates should be directed to the study team contact.

Drug
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Mayo Clinic — Rochester, MN

Attitudes and Beliefs About Gene Transfer Therapy in Adults with Cocaine Use Disorder (AGTT)

Attitudes and Beliefs About Gene Transfer Therapy in Adults with Cocaine Use Disorder

William Hooten
All
18 years and over
This study is NOT accepting healthy volunteers
2020-102081-H01-RST
20-002818
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Inclusion Criteria:

  • Age greater than 18 years, no upper age limit.
  • Previous diagnosis of opioid use disorder in sustained remission.


Exclusion Criteria:

  • History of schizophrenia, dementia, or other chronic psychiatric disorder that could be adversely impacted by study participation.  Subjects may also be excluded for other comorbid mental health conditions based on the physician investigator’s discretion.
  • Inability to function independently in an ambulatory care setting.  Subjects may be excluded for other functional problems based on the physician investigator’s discretion.
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Mayo Clinic — Rochester, MN

A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System

A Pivotal Study of the Premia Spine TOPS™ System

Ahmad Nassr
All
35 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-119195-P01-RST
16-009345
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Inclusion Criteria:

  • Be between 35 and 80 years of age.
  • Must demonstrate at the level to be treated (L2/3, L3/4 or L4/5) all three of the following:
    • Degenerative spondylolisthesis or retrolisthesis up to Grade I, as determined by the investigator based on flexion/extension X-rays, and;
    • At least moderate lumbar spinal stenosis, defined as greater than a 33% reduction in either the central canal, the lateral recess space, and/or the foramen when compared to an adjacent level, as determined by the investigator based on MRI, and;
    • Thickening of the ligamentum flavum and/or scarring of the facet joint capsule as identified by the investigator based on MRI.
  • Have had at least six (6) months of failed conservative treatment prior to surgery (e.g., physical therapy, use of anti-inflammatory medications at maximum recommended dosage; administration of epidural/facet injections and/or nerve block).
  • Have an Oswestry Disability Index (ODI) score of at least 40/100 at baseline.
  • Have leg pain with a VAS score of at least 40/100 for at least one leg at baseline.
    • The leg with the higher pain score will be considered “Worst Leg.”
  • Neurogenic claudication (as defined by worsening leg/buttock symptoms when walking or standing, which is reduced when sitting or bending forward).
  • Demonstrate worse symptoms (e.g., pain, numbness, burning sensation, pin prick sensation, etc.) in the legs/buttock than in the lower back.
  • Be psychosocially, mentally and physically able to fully comply with the clinical protocol.
  • Be willing to adhere to the follow-up schedule and protocol requirements.
  • The patient is willing and able to understand and sign the study-specific, IRB approved consent form.


Exclusion Criteria:

 

  • More than one (1) motion segment involved in the degenerative pathology that requires a surgical procedure.
  • Presence of free fragment disc herniation or prior discectomy at the index level or either adjacent level.
  • Less than 4mm of disc height at the index level.
  • Spondylolisthesis greater than Grade I.
  • Traumatic or dysplastic spondylolisthesis.
  • Lytic spondylolisthesis.
  • Back or non-radicular leg pain of unknown etiology.
  • Stenosis caused by an extruded spinal disc fragment (e.g., herniation) or where the etiology is considered to be congenital, iatrogenic, post-traumatic, or metabolic.
  • Known allergy or sensitivity to PEEK, titanium, cobalt chrome, and/or polyurethane.
  • Prior surgery at any lumbar vertebral level with instrumentation.
  • Prior surgery at the index vertebral level or either adjacent lumbar vertebral level without instrumentation [exception – prior intervention of posterior elements at index level (e.g., rhizotomy, laminectomy, foraminotomy and/or facetectomy)].
    • Prior intervention of posterior elements that involve the lamina, foramen, or and/or facets, the extent of which must not be greater than the decompression that would be necessary to implant TOPS.
  • Clinically compromised vertebral bodies at the affected level due to any traumatic, neoplastic, metabolic or infectious pathology.
  • Scoliosis greater than ten (10) degrees by major Cobb angle (both angular and rotational).
  • Morbid obesity defined as a body mass index > 40.
  • Osteoporosis (lumbar spine T score < -2).
    • All subjects will be screened for osteoporosis using an osteoporosis risk score (SCORE). Subjects with a SCORE value greater than 6 will be referred for DEXA Scan. DEXA must be performed within the 6 months prior to surgery.
  • Paget's disease, gout, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder and/or any other metabolic bone disease that has not been stabilized with ongoing medication for at least one year.
  • Active infection
    •systemic or local.
  • Active hepatitis.
  • AIDS, HIV, Rheumatoid arthritis or other autoimmune disease.
  • Tuberculosis
    •active or in the past 3 years.
  • Active malignancy
    •history of any invasive malignancy (except non-melanoma skin cancer) unless prior treatment with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
  • Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study.
  • Cauda equina syndrome or neurogenic bowel/bladder dysfunction.
  • Vascular claudication due to severe arterial insufficiency of the legs (Prospective subjects will be screened by physical examination for diminution or absence of dorsalis pedis or posterior tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is required with vascular plethysmography. If the absolute arterial pressure is below 50 mm Hg at the calf or ankle level, then the patient has severe arterial insufficiency and must be excluded).
  • Sustained pathologic lumbar fractures of the vertebra or multiple lumbar fractures of the vertebra or hip.
  • Significant peripheral neuropathy causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities.
  • Insulin-dependent diabetes mellitus (unless well-controlled defined as HbA1c < 7%).
    • HbA1c value must be within 3 months of screening.
  • Immunologically suppressed, receiving steroids > 1 month out of the past year.
  • Currently taking anticoagulants other than aspirin unless the subject can be taken off the anticoagulant prior to and during surgery.
  • Life expectancy less than 3 years.
  • Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin.
  • History of or current chemical/alcohol dependency.
    • A maladaptive pattern of substance use leading to clinically significant impairment or distress, as manifested by one (or more) of the following, occurring within a 12-month period:
      • Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, home (e.g., repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; neglect of children or household);
      • Recurrent substance use in situations in which it is physically hazardous (e.g. driving as automobile or operating a machine when impaired by substance use);
      • Recurrent substance-related legal problems (e.g. arrests for substance-related disorderly conduct);
      • Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (e.g. arguments with spouse about consequences of intoxication, physical fights).
  • Smoking habit of more than 1 pack of cigarettes per week and/or frequent users (>1/week) of chewing tobacco.
  • Pregnant or interested in becoming pregnant in the next 3 years (due to need for Xrays).
    • However, pregnancies occurring during the study will not be considered protocol deviations. Additionally, if a subject does become pregnant, no X-ray or MRI should be taken during the pregnancy.
  • Currently involved in active spinal litigation.
  • Currently having a workman's compensation claim.
  • Currently incarcerated.
  • Participation in any other investigational drug, biologic or medical device study within the 30 days prior to the study surgery.
Device, Procedure/Surgery, Insertion of segmental instrumentation to spine for spinal arthrodesis, Primary transforaminal interbody fusion of joint of lumbar spine, Stabilization of spine
Lumbar spinal stenosis, Spondylolisthesis
Degenerative spondylolisthesis, Neurogenic claudication, Retrolisthesis, Spinal stenosis of lumbar region
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Mayo Clinic — Rochester, MN

Acute Detection of Non-convulsive Seizures with Single-channel EEG

A Study to Detect Non-convulsive Seizures with Single-channel Electroencephalogram (EEG)

Alejandro Rabinstein
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122067-H01-RST
19-003718
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Inclusion Criteria:

  • Patients admitted with encephalopathy concerning for non-convulsive seizures or NCSE who can also undergo conventional multi-lead EEG monitoring.
  • ≥ 18 years of age.


Exclusion Criteria:
 

  • Patients who have dermatologic contraindication to the adhesive by which the portable EEG device is attached.
  • < 18 years of age.

 

Encephalopathy, Seizure
Disorder of brain, EEG, Generalized seizure, Nervous system, Nonconvulsive status epilepticus
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Mayo Clinic — Rochester, MN

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

- Documented tubal ligation

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

- Hysterectomy

- Documented bilateral oophorectomy.

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

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

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

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


Exclusion Criteria:


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

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

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

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

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

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

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

- Patients with chronic pain associated with significant psychosocial dysfunction.

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

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

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

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

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

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

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

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

- Female patients who are breast-feeding.

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

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

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

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

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

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

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

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

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

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

Drug, Other
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INCB54828-302 A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302) (FIGHT-302)

A Study to Evaluate the Effectiveness and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

Nguyen Tran
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100571-P01-RST
18-003888
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Inclusion Criteria:
 

  • Ability to comprehend and willingness to sign a written ICF for the study.
  • Male and female participants at least 18 years of age at the time of signing the ICF; a legally minor participant from Japan needs written parental consent.
  • Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the AJCC Cancer Staging Manual [AJCC 2002]).
  • Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria (Eisenhauer et al 2009).
  • ECOG performance status 0 to 1.
  • Documented FGFR2 rearrangement.


Exclusion Criteria:
 

  • Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment).
  • Child-Pugh B and C.
  • Toxicities related to prior therapy(ies) must be CTCAE v5.0 ≤ Grade 1 at the time of screening.
  • Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization), other than the therapies being tested in this study.
  • The participant must not be a candidate for potentially curative surgery.
  • Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, retinal detachment) as confirmed by ophthalmologic examination
  • Radiation therapy administered within 4 weeks of enrollment/randomization/first dose of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. Evidence of fibrosis within a radiation field from prior radiotherapy is permitted with medical monitor approval. A 2-week washout is permitted for palliative radiation to non-CNS disease.
  • Known CNS metastases or history of uncontrolled seizures. Participants with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period, and they are on stable or decreasing dose of corticosteroids for at least 1 week.
  • Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Participants with laboratory values at screening defined below:
  • Hematology
    • Platelets | ≤ 75/100 × 109/L (transfusion allowed with 2-week washout period);
    • Hemoglobin | ≤ 9.0 g/dL (transfusion allowed with 2-week washout period);
    • ANC | ≤ 1.5 × 109/L.
  • Hepatic 
    • ALT | > 2.5 × ULN (> 5 × ULN if related to underlying disease or the presence of liver metastases);
    • AST | > 2.5 × ULN (> 5 × ULN if related to underlying disease or the presence of liver metastases);
    • Total bilirubin | ≥ 1.5 × ULN (≥ 2.5 × ULN if Gilbert syndrome).
    • NOTE: Participants with biliary drainage to improve liver function tests to meet above criteria are allowed.
  • Renal 
    • < 60 mL/min based on Cockcroft-Gault formula.
  • Chemistry 
    • Serum phosphate | > ULN;
    • Serum calcium | Outside of normal range or serum albumin-corrected calcium outside of the normal range when serum albumin is outside of the normal range.
  • History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues, such as the skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
  • Gastrointestinal conditions/disorders that may raise gastric and/or small intestinal pH that could interfere with absorption, metabolism, or excretion of pemigatinib.
  • Inability of the participant to swallow and retain oral medication
  • Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment administration, New York Heart Association Class III and IV congestive heart failure, and uncontrolled arrhythmia (participants with pacemaker or with atrial fibrillation and well controlled heart rate are allowed).
  • History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful. A screening QTcF interval > 480 milliseconds is excluded. For participants with an interventricular conduction delay (QRS interval >120 ms), the JTc interval may be used in place of the QTc with sponsor approval (the JTc must be ≤ 340 milliseconds if JTc is used in place of the QTc).
  • Chronic or current active infectious disease requiring systemic antibiotics or antifungal or antiviral treatment within 2 weeks prior to enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed). Note: HIV-positive participants are allowed if all of the following criteria are met: CD4+ count > 300/uL, undetecable viral load, receiving antiretroviral therapy that does not interact with study drug, and no HIV/AIDS-associated opportunistic infection in the last 12 months. 
  • Current use of prohibited medication.
  • Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. Note: Moderate CYP3A4 inhibitors are not prohibited.
  • Known hypersensitivity or severe reaction to pemigatinib, gemcitabine, cisplatin, or their excipients (refer to the IB and commercially available product information sheets).
  • Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations in the opinion of the investigator.
  • Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
  • For NA, EU, and ROW participants, women who are pregnant or breastfeeding or participants expecting to conceive or father children within the projected duration of the study, starting with the screening visit through completion of safety follow-up or through 90 days from the date of last dose of pemigatinib and 6 months after the last dose of gemcitabine and/or cisplatin for male participants.
  • For Japanese participants, pregnant or breastfeeding women or participants expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after last dose of pemigatinib (men; based on the spermatogenetic cycle) and 30 days after last dose of pemigatinib (women; based on menstrual cycle) and 6 months after the last dose of gemcitabine and/or cisplatin (men and women). Female participants who are breastfeeding and wish to enroll must discontinue breastfeeding before receiving study drug and must not resume breastfeeding until at least 30 days after last dose of study treatment, which exceeds 5 times the half-life of pemigatinib.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Inability of the participant (or parent, guardian, or legally authorized representative) to comprehend or unwilling to sign the ICF.
  • Any contraindication to gemcitabine or cisplatin as per each SmPC or product insert.
  • History of hypovitaminosis D requiring supraphysiologic doses (e.g., 50,000UI/weekly) to replenish the deficiency. Participants receiving vitamin D supplements are allowed.

 

Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Experimental therapeutic procedure
Cancer, Cholangiocarcinoma
1,2-Diaminocyclohexaneplatinum II citrate, Cancer treatment, Chemotherapy, Cholangiocarcinoma of biliary tract, Digestive system, Gemcitabine [USAN:INN:BAN], Medical Oncology, Pemigatinib, cisplatin, gemcitabine
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Collection of Pharmacogenomics (PGx) results and clinical data of participants of the Individualized Medicine Clinic for assessing current and future therapeutic relevance.

Pharmacogenomics (PGx) results and clinical data for assessing current and future therapeutic relevance.

Konstantinos Lazaridis
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-119231-H01-RST
16-009621
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Inclusion Criteria:

  • A Mayo Clinic patient within a department piloting PGx testing with the Center for Individualized Medicine, seeking clinical information from emerging PGx testing technologies available in CLIA/CAP laboratories.
  • Patient age 18 or above.
  • Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.
  • Patient is willing to engage in a medication assessment as part of their clinical visit preparation (when needed)


Exclusion Criteria:

  • Patient with uncontrolled concurrent illness including psychiatric illness
  • Situations that would limit compliance with the study requirements
  • Not able to willingly give written informed consent.
Genetic, Pharmacogenetic consultation
Genetic testing, Medication management, Pharmacogenomic testing
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MOVE TRIAL: A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)

An Efficacy and Safety Study of Palovarotene for the Treatment of FOP

Robert Pignolo
All
4 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-120447-P01-RST
17-011358
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Key

Inclusion Criteria:

  • Written, signed, and dated informed subject/parent consent; and for subjects who are minors, age-appropriate assent (performed according to local regulations).
  • Males or females at least 4 years of age.
  • Previous participation in Clementia's natural history study (NCT02322255); clinically diagnosed with FOP, with the R206H ACVR1 mutation or other FOP variants reported to be associated with progressive HO (who have not participated in any Clementia-sponsored study); participants in Clementia's Phase 2 studies (NCT02279095 and NCT02979769) who cannot currently receive the chronic/flare-up regimen due to country of residence or those traveling long distances to participate in the Phase 2 studies.
  • No flare-up symptoms within the past 4 weeks, including at the time of enrollment.
  • Abstinent or using two highly effective forms of birth control.
  • Accessible for treatment and follow-up; able to undergo all study procedures including low-dose WBCT (excluding head) without sedation.

Key


Exclusion Criteria:

  • Weight <10 kg.
  • Concomitant medications that are strong inhibitors or inducers of cytochrome P450 (CYP450) 3A4 activity; or kinase inhibitors such as imatinib.
  • Amylase or lipase >2x above the upper limit of normal (ULN) or with a history of chronic pancreatitis.
  • Elevated aspartate aminotransferase or alanine aminotransferase >2.5x ULN.
  • Fasting triglycerides >400 mg/dL with or without therapy.
  • Female subjects who are breastfeeding.
  • Subjects with uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, immunologic, psychiatric, or other significant disease.
  • Simultaneous participation in another clinical research study (other than palovarotene studies) within 4 weeks prior to Screening; or within five half-lives of the investigational agent, whichever is longer.
  • Any reason that, in the opinion of the Investigator, would lead to the inability of the subject and/or family to comply with the protocol.
Drug, Drug therapy
Progressive myositis ossificans
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Mayo Clinic Rochester, MN — Rochester, MN

Research for Individualized Therapeutics in Rare Genetic Disease

Individualized Therapeutics in Rare Genetic Disease

Brendan Lanpher
All
Not specified
This study is NOT accepting healthy volunteers
2021-305076-H01-RST
21-006562
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Inclusion Criteria:

  • Has Mayo Clinic or other medical health system ID, or another unique identifier.
  • Able to provide informed consent.
  • Individual must have evidence of a genetic disorder as determined by a provider or genetic counselor with causative or likely causative genetic variants identified by molecular testing.
  • Genetic variants must be hypothesized to be targetable using antisense oligonucleotide drugs (such as: knockdown gain of function alterations, increase protein production for reduced function alterations, or modulate mRNA splicing to correct abnormal splicing, promote normal splicing, or return reading frame to an out-of-frame transcript to restore function, etc.) based on current acceptable understanding of ASO mechanisms of action and tissue/organ targeting efficiency.
  • Biological family member of an enrolled individual.
  • Would be able to travel to a Mayo Clinic site for ongoing treatment should a therapeutic be developed.
  • Treatment at the individual’s current disease state would likely provide benefit based on current clinical data and understanding of the progression of the disease.

 Exclusion Criteria

  • Individuals who have situations that would limit compliance with the study requirements.
  • Institutionalized (i.e., Federal Medical Prison).
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Genomically-Guided Treatment Trial in Brain Metastases

A Study to Evaluate Genetic Testing in Guiding Treatment for Patients with Brain Metastases

Sani Kizilbash
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100069-P01-RST
19-010598
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Inclusion Criteria:

PRE-REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS)

  • Tissue available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy).

REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS)

  • Participants must have histologically confirmed metastatic disease to the brain from any solid tumor. Note: this includes patients that have controlled extracranial disease with progressive intracranial metastasis, as well as patients that have progressive intracranial and extracranial disease. 
  • New or progressive brain metastases are defined as any one of the following: 
    • Untreated measurable lesions in patients who have received surgery and/or stereotactic radiosurgery (SRS) to one or more other lesions; 
    • Residual or progressive lesions after surgery if asymptomatic; 
    • Patients who have had prior whole-brain radiotherapy (WBRT) and/or SRS and then whose lesions have progressed by BM-RANO criteria or there are new lesions, are eligible. Lesions treated with SRS may be eligible if there is unequivocal evidence of progression;
    • Patients who have not previously been treated with cranial radiation (e.g., WBRT or SRS) are eligible, but such patients must be asymptomatic or neurologically stable from their CNS metastases. 
  • Measurable CNS disease (> 10 mm). 
  • Ability to obtain magnetic resonance imaging (MRI)s. 
  • No surgery within 2 weeks prior to or after registration.
  • No chemotherapy within 14 days prior to registration
    • Note: for abemaciclib arm, a 21-day chemotherapy washout is required).
    • For melanoma, patients must have progressed after prior immune checkpoint blockade or for BRAF positive melanoma, BRAF/MEK inhibitors.
    • For lung cancer, EGFR mutant patients must have failed EGFR therapies
    • For HER2-positive breast cancer patients, patients must have received at least one prior HER-2 directed therapy in the metastatic setting.
    • For triple negative breast cancer (TNBC), patients must have received at least one chemotherapy in the metastatic setting. 
    • For estrogen receptor (ER)/progesterone receptor (PR)+ breast cancer, patients must have received at least one endocrine therapy in the metastatic setting. 
    • Breast cancer patients who have received ribociclib or palbociclib are eligible as long as there is documentation of CDK4 pathway alteration on a biopsy at the point of progression post-ribociclib or palbociclib.
  • Tissue available for sequencing (any brain metastasis tissue and extracranial site from any prior resection or biopsy that was resected as part of clinical care). If the patient does not have any evidence of extracranial disease, brain metastasis tissue is sufficient for eligibility.
  • Presence of clinically actionable alteration in NTRK, ROS1, or CDK pathway or PI3K pathway in both a brain metastasis and extracranial site. 
  • Not pregnant and not nursing, because this study involves investigational agents whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required.
    • Note: for abemaciclib arm, pregnancy test is required ≤ 7 days prior to registration.
    • No known leptomeningeal involvement. 
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Adequate organ function.
    •Absolute neutrophil count (ANC) ≥ 1,500/mm^3.
  • Platelet count ≥ 100,000/mm^3. 
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except in patients with Gilbert's disease. 
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN). 
  • Creatinine ≤ 1.5 mg/dL OR calculated (Calc.) creatinine clearance > 45 mL/min. 
  • No uncontrolled medical comorbidities per investigator discretion (e.g., interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • Concurrent radiation to symptomatic non-target sites within neural axis is allowed (provided there is at least one untreated target lesion). 
  • Concurrent systemic corticosteroids are allowed if stable dose of dexamethasone for 7 days prior to registration. Baseline doses and changes in steroid dosing will be captured. 
  • No concurrent administration of anticancer therapies (except for endocrine therapy or continuation of hormonal therapy or trastuzumab in breast cancer patients). No chemotherapy, targeted therapy or immunotherapy within 14 days prior to entering the study
    •  Note: For abemaciclib arm, a 21-day chemotherapy washout is required. 
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to registration on the study. 
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR GDC-0084 ARM

  • Urine protein to creatinine (UPC) ratio < 1 or urine protein ≤ 1. 
  • Recent acute myocardial infarction in the last 6 months or current angina pectoris are excluded. Patients with symptomatic bradycardia should have an electrocardiogram at baseline. If QT interval > 470 msec, the patient is excluded. 
  • Patients with uncontrolled type I or II diabetes mellitus should be excluded. Uncontrolled diabetes is defined as glycosylated hemoglobin (HbA1c) > 9% in addition to fasting glucose > 140 mg/dL on at least 2 occasions within 14 days prior to registration.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ENTRECTINIB ARM

  • Concurrent use of H2 receptor antagonists, receptor antagonists, proton pump inhibitors (PPIs), and/or antacids are prohibited.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM

  • Hemoglobin ≥ g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion. 
  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy). 
  • Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and registration. 
  • For females of childbearing potential: A female of childbearing potential, must have a negative serum pregnancy test within 7 days prior to registration and agree to use a highly effective contraception method during the treatment period and for 3 weeks following the last dose of abemaciclib. Contraceptive methods may include an intrauterine device [IUD] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. Cases of pregnancy that occur during maternal exposures to abemaciclib should be reported. If a patient or spouse/partner is determined to be pregnant following abemaciclib initiation, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation. 
  • Patients with active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive] are excluded. Screening is not required for enrollment.
  • Patients with personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest, are excluded.
Drug, Genetic
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A Phase 2 study to assess the efficacy and safety of 2 dosage regimens of oral fidrisertib (IPN60130) for the treatment of fibrodysplasia ossificans progressiva in male and female pediatric and adult participants (IPN60130)

A Study Assessing the Efficacy and Safety of 2 Dosage Regimens of Oral IPN60130 for FOP

Robert Pignolo
All
5 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305740-P01-RST
21-008980
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Key

Inclusion Criteria:


- Participants must be at least 5 years of age, to be confirmed (entry for younger
paediatric participants <15 years of age will only be once safety in adult and older
paediatric participants ≥15 years of age has been established) at the time of signing
the informed participant/parent consent and, for participants who are minors,
age-appropriate assent.

- Participants must be at least 15 years of age at the time of signing the informed
participant/parent consent for the main study and, for participants who are minors,
age-appropriate assent

- Participants must be clinically diagnosed with FOP, with the R206H ACVR1 mutation or
other FOP variants associated with progressive HO.

- Participants must have disease progression in the preceding year of the screening
visit.

- Participants who have participated in a prior clinical study using another
investigational product for the treatment of FOP may be enrolled after a washout of at
least 5 half-lives of the other investigational product. Participants with prior
treatment such as, but not limited to, imatinib, isotretinoin, garetosmab, or
palovarotene may be enrolled 30 days after discontinuation or after washout of at
least 5 half-lives, whichever is longer.

1. Washout period for palovarotene is 30 days

2. Washout period for garetosmab is 4 months

- Participants must be able to perform pulmonary function tests adequately and reliably.

- Participants must be able to have an adequate echocardiography assessment at screening
for evaluation of left ventricular structure and function as defined by the protocol.

- Participants must be accessible for treatment and follow-up and be able to undergo all
study procedures. Participants living at distant locations from the investigational
site must be able and willing to travel to a site for the initial and all on-site
follow-up visits. Participants must be able to undergo low-dose WBCT (excluding head)
without sedation.

- Body weight ≥10 kg.

- Abstinent or using two highly effective forms of birth control. Females must also have
a negative blood or urine pregnancy test prior to administration of study drug.

- Participants must be capable of giving written, signed, and dated informed
participant/parent consent; and for participants who are minors, age-appropriate
assent and/or legal guardian consent (performed according to local regulations)

Key
Exclusion Criteria:


- Participants with complete heart block and left bundle branch block on screening
electrocardiogram.

- Participants with screening echocardiography showing septal or left ventricular free
wall thickness >12 mm for adult participants or a z-score >3 compared with population
norms for children and adolescent participants or left ventricular ejection fraction
(LVEF) <50%.

- Participants with severe mitral or tricuspid regurgitation on echocardiography at
screening.

- Participants with significant underlying lung disease requiring supplementary oxygen
or forced vital capacity <35% of predicted at screening.

- Participants with uncontrolled cardiovascular, hepatic, pulmonary, gastrointestinal,
endocrine, metabolic, ophthalmologic, immunologic, psychiatric, or another significant
disease as judged by the investigator.

- Participants with severe hepatic impairment.

- Concomitant medications that are strong inhibitors (including grapefruit juice) or
inducers (including St John's Wort) of cytochrome P450 (CYP) 3A4 activity; or kinase
inhibitors such as imatinib.

- Prior use in the past year and concomitant use of bisphosphonates for participants in
the PET-CT sub study.

- Concurrent participation in another interventional clinical study, or a
noninterventional study with radiographic measures or invasive procedures (e.g.
collection of blood or tissue samples).

- Amylase or lipase >2× the upper limit of normal (ULN) or with a history of chronic
pancreatitis.

- Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5×ULN.

- Participants with hematologic abnormalities:

- Hgb<10g/dL

- Platelets<75,000/mm3

- WBC<2000/mm3

- Participants with coagulation test measurements outside of the normal range at
screening.

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

Eligibility last updated 7/11/23. Questions regarding updates should be directed to the study team contact.

Drug, Other
BLU-782, Progressive myositis ossificans
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Role of Biomarkers in Risk Stratification in Adults with Congenital Heart Disease: The ACHD Biobank Project

A Study to Assess the Role of Biomarkers in Risk Stratification in Adults with Congenital Heart Disease

Alexander Egbe
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121771-H01-RST
19-001161
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Inclusion Criteria:

  • Adult patients (age ≥ 18 years)
  • Adult patients with diagnosis of Congenital Heart Disease (i.e., Tetralogy of Fallot (TOF), Pulmonary Atresia, Coarctation of Aorta, etc.).


Exclusion Criteria:
 

  • Patients without research authorization.

Eligibility last updated 11/10/21. Questions regarding updates should be directed to the study team contact.

 

 

 

 

Coarctation of the aorta, Congenital heart defects in adults, Ebstein anomaly, Pulmonary atresia, Pulmonary valve stenosis, Tetralogy of Fallot, Transposition of the great arteries
Atresia of pulmonary valve, Cardiovascular system, Coarctation of aorta, Congenital stenosis of pulmonary valve, Corrected transposition of great vessels, Ebstein's anomaly, History of creation of conduit of right atrium and pulmonary artery, L - transposition of the great vessels, Tetralogy of Fallot
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Mayo Clinic — Rochester, MN

CA224-020: A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Matthew Block
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-100328-P01-RST
17-010030
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Inclusion Criteria:

  • For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
  • For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC
  • Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts.
  • ECOG performance status of 0 or 1
  • At least 1 lesion with measurable disease at baseline
  • Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)


Exclusion Criteria:

  • Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
  • Autoimmune disease
  • Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
  • Uncontrolled CNS metastases

Biologic/Vaccine, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Bladder cancer, Cancer, Cervical cancer, Colon cancer, Head and neck cancer, Hepatocellular carcinoma, Kidney cancer, Liver cancer, Lung cancer, Melanoma, Non-small cell lung cancer, Ovarian cancer, Rectal cancer, Skin cancer, Stomach cancer
Biological therapy for cancer, Cancer treatment, Digestive system, Integumentary system, MDX-1106, Malignant neoplastic disease, Medical Oncology, Relatlimab [USAN], Reproductive system, Respiratory system, Solid tumor configuration, Urinary system, nivolumab
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Mayo Clinic — Rochester, MN

A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

Anthony Windebank
All
18 years to 75 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-120205-P01-RST
17-008763
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Inclusion Criteria:

  • Are between the ages of 18-75 years.
  • Have clinical indications for whole sural nerve biopsy.
  • Have a sural nerve SNAP with amplitude > or = 2 μV.
  • Are able to comply with protocol requirements.
  • Can provide written informed consent.
  • Willingness to complete study procedures.


Exclusion Criteria:

  • Current smoker.
  • History of prior musculoskeletal (joint or soft tissue) infection.
  • Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
  • Have systemic immune disorders, such as Crohn’s Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism.
  • Have diabetes mellitus.
  • Have previous trauma to the biopsy site.
  • Have any major, clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient.
  • Any of the following because this study involves an investigational device of which the effects on pregnant women, the developing fetus and newborn are unknown:
    • Pregnant women.
    • Nursing women.
    • Men or women of childbearing potential (WOCBP) who are unwilling to employ adequatecontraception.
      • Note: WOCBP must agree to follow instructions for method(s) of contraception for the duration of the study, for 2 years following implantation of the device.
    • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of the study, for 2 years following implantation of the device.
    • Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancy testing as described in this section.
      • Note: Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly.
  • At a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:
    • Male condoms with spermicide
    • Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena® by WOCBP subject or male subject’s WOCBP partner.
    • Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug.
    • IUDs, such as ParaGard®.
    • Tubal ligation.
    • Vasectomy.
    • Complete Abstinence*.
  • *Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.
Device, Radiation, Biopsy of sural nerve
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An Open-label Extension Study for Participants Who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Marius Stan
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2022-309692-P01-RST
22-010513
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Inclusion Criteria
•For All Participants:

  • Have completed the Week 24 visit of the feeder study.

Inclusion Criteria
•For Participants Assigned to the Open-label Treatment Cohort:

  • Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
  • Did not permanently discontinue batoclimab.

Exclusion Criteria
•For All Participants:

  • In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.

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

Eligibility last updated 9/30/22. Questions regarding updates should be directed to the study team contact.

Other, Drug
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GC-LTFU-001 - Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

Yi Lin
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-100331-P01-RST
17-011220
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Inclusion Criteria:

Subjects who meet the following criteria will be eligible to participate in the Long-Term Follow-Up study:

  • All adult and pediatric subjects who received at least one GM T cells infusion in a previous Celgene sponsored or Celgene alliance partner sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
  • Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.


Exclusion Criteria:

  • None.
Genetic, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer
Biological therapy for cancer, Cancer treatment, Gene therapy, Malignant neoplastic disease, Medical Oncology
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Mayo Clinic — Rochester, MN

Therapeutic and Side Effects of Invasive and Noninvasive Brain Stimulation

A Study to Evaluate Therapeutic and Side Effects of Brain Stimulation

Brian Lundstrom
All
1 years to 99 years old
This study is NOT accepting healthy volunteers
2020-302381-H01-RST
19-002063
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Key Inclusion Criteria:

  • Patients that receive brain stimulation for evaluation or treatment of neurological diseases including intractable epilepsy, chronic pain syndromes and brain tumors.

Key Exclusion Criteria

  • Patients that do not receive brain stimulation for evaluation or treatment of neurological diseases including intractable epilepsy, chronic pain syndromes, and brain tumors.

     

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Location Contacts
Mayo Clinic — Rochester, MN

Detection of Esophageal Cancer by Assay of Novel Methylated DNA Markers in Plasma, a Phase II Study

Detection of Esophageal Cancer by Assay of Novel Methylated DNA Markers in Plasma

John Kisiel
All
18 years and over
This study is NOT accepting healthy volunteers
0000-120879-H01-RST
18-004438
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Study Criteria:

Exclusions:

  • Age < 18
  • Primary cancer outside of the esophagus within the last 5 years (not including basal or squamous cell skin cares)
  • History of Esophageal cancer
  • Intervention to completely remove the current target pathology
  • Any endoscopic treatment to current target pathology [Endoscopic intervention examples: Photodynamic therapy, Halo, Cryotherapy, Multi-polar coagulation]
  • Prior chemotherapy class drugs or radiation for the primary esophageal cancer prior to blood or stool collection
  • Biopsy (excluding skin) and/or brushing 3 days prior to blood collection  
  • IV contrast given within 24 hours of blood collection

 

Additional Stool Exclusions:

  • Bowel prep <7 days prior to stool collection
  • Oral contrast given within 7 days of stool collection
  • Removal of more than 50% of colon or presence of ileostomy
  • Enteral feeds or TPN
  • Diagnosis of inflammatory bowel disease
  • If patient has had colonoscopy within 5 years, were pre-cancerous polyps (>1cm or villous)
  • Enteric barium studies within the prior 7 days of stool collection
Cancer, Esophageal cancer, Squamous cell carcinoma of the skin
Adenocarcinoma of esophagus, Digestive system, Integumentary system, Medical Oncology, Squamous cell carcinoma of esophagus
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Mayo Clinic — Rochester, MN

Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma

A Study Identifying Predictive Biomarkers for the Progression of Invasive Squamous Cell Carcinoma

Dennis Wigle
All
18 years and over
This study is NOT accepting healthy volunteers
0000-117257-H01-RST
15-000548
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Inclusion Criteria

  • known or suspected squamous cell carcinoma of the lung
  • able to provide consent
  • could have already had a bronchoscopy or surgical resection with tissue saved at the Mayo Clinic Rochester
  • will be undergoing a bronchoscopy and having a surgical resection at the Mayo Clinic Rochester

 

Exclusion Criteria

  • unable to provide consent
  • pregnant

 

Cancer, Lung cancer, Squamous cell carcinoma of the skin
Bronchoscopy, Integumentary system, Medical Oncology, Respiratory system, Squamous cell carcinoma of bronchus, Squamous cell carcinoma of lung
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Mayo Clinic — Rochester, MN

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)

The majority of drugs administered to children are used off label, and PK studies to define appropriate dosing are lacking across pediatric age groups and special populations of children. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard-of-care procedures have proven successful in characterizing the PK of drugs used in children. The purpose of this study is to characterize the PK of understudied drugs administered to children per SOC as prescribed by their treating provider. This study will serve as a tool to better understand drug exposure in children receiving drugs per SOC. The data collected through this initiative will provide valuable PK and dosing information for drugs in different pediatric age groups as well as special populations of children, such as premature infants, critically ill children receiving ECMO or CRRT, children with Down syndrome and children with obesity, for which dosing may vary due to altered PK. In addition, the data collected in this study will serve as preliminary data to design and plan the best and most efficacious BPCA trials, proof-of-concept studies associated with biomarkers, and data to support applications for extramural funding. All of the drugs studied in this protocol are used as standard of care in children and are approved in adults. There will be multiple INDs held by the core study Principal Investigator: Danny Benjamin, MD, PhD (IND Sponsor) Kiser-Arena Distinguished Professor of Pediatrics, Duke University Faculty Associate Director, Duke Clinical Research Institute PO Box 17969 Durham NC 27715 Phone: 919-668-8295 Fax: 919-681-9457 danny.benjamin@duke.edu The Funding Sponsor is The National Institute of Child Health and Human Development (NICHD) NOTE: We will be participating in the COVID 19 arm of this study, which includes 6 drugs of interest (DOI). All other arms are on hold currently; and focus has been placed on the COVID 19 arm. However, in the future we may be interested in participating in other DOIs. The details of this arm of the study will be provided at the end of this document. (See Appendix P, pages 82-86 of main protocol)

Catherine Bendel
bende001@umn.edu
All
up to 20 Years old
This study is also accepting healthy volunteers
NCT04278404
STUDY00009884
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Inclusion Criteria:
1. Participant is < 21 years of age and 1. is receiving understudied drugs of interest (DOIs) per standard of care (SOC) as prescribed by their treating provider OR 2. is NOT receiving one or more of the study drugs of interest but is SARS-CoV-2 positive within 60 days prior to enrollment 2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA
Exclusion Criteria:
1. Participant has a known pregnancy For participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications) 2. Has had intermittent dialysis within previous 24 hours 3. Has had a kidney transplant within previous 30 days 4. Has had a liver transplant within previous 1 year 5. Has had a stem cell transplant within previous 1 year 6. Has had therapeutic hypothermia within previous 24 hours 7. Has had plasmapheresis within the previous 24 hours 8. Has a Ventricular Assist Device 9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis, Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
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See this study on ClinicalTrials.gov
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Location Contacts
University of Minnesota — Minneapolis, Minnesota Catherine Bendel - (bende001@umn.edu) Amanda Galster - (gals0004@umn.edu)