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

3802 Study Matches

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Arthroscopic Partial Meniscectomy in OA: A 12-Year Follow-Up (MeTeOR)

Arthroscopic Partial Meniscectomy in OA: A 12-Year Follow-Up

Bruce Levy
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2020-301049-P01-RST
20-005053
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Inclusion Criteria:

  • Participants with knee pain of at least four weeks duration and present with at least one mechanical symptom (e.g., clicking, popping, locking, giving way).
  • Potential subjects required to have meniscal tear confirmed by MRI and evidence of cartilage damage or osteophyte on MRI or radiograph.


Exclusion Criteria:

  • Subjects with inflammatory arthritis, prior APM, or workers’ compensation, as well as subjects with Kellgren-Lawrence (KL) Grade 4 radiographs (advanced OA).

 

 

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Mayo Clinic — Rochester, MN

Evaluation of the Clinical Performance and Safety of an Investigational Fully Covered Biliary Stent with Anti-migration Flaps for the Palliative Treatment of Malignant Biliary Obstruction HANAROSTENT® Biliary Flap Lasso Stent System IDE Study (H-IDE)

A Study to Evaluate the Safety of HANAROSTENT® Biliary Flap Lasso Stent System Use to Treat Cancer Patients with Biliary Obstruction

Ryan Law
All
18 years and over
Pivotal
This study is NOT accepting healthy volunteers
2021-304302-P01-RST
21-003551
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Inclusion Criteria:

  • Presence of inoperable malignant nonhilar extrahepatic biliary obstruction.
  • Clinical symptoms of biliary obstruction.
  • ≥ 18 years of age.
  • Willing and able to provide informed consent.


Exclusion Criteria:

  • Participation in another investigational study within 90 days prior to consent.
  • Strictures that could not be traversed by the delivery system.
  • Perforation of any duct within the biliary tree.
  • Presence of a biliary SEMS.
  • Presence of any esophageal or duodenal stent.
  • Contraindications to endoscopy.
  • Sensitivity to any components of the stent or delivery system.
  • Active hepatitis.
  • Intrahepatic metastases that extensively involve both lobes of the liver.
  • Life expectancy of < 3 months.
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ATHN 16: Safety of SEVENFACT for the Treatment of Bleeding Events in Patients with Hemophilia A or B with Inhibitors (ATHN 16)

SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Rajiv Pruthi
All
12 years and over
Phase 4
This study is NOT accepting healthy volunteers
2021-305182-P01-RST
21-008012
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Inclusion Criteria:


1. Have a diagnosis of hemophilia A or B with inhibitors.

2. Be 12 years of age and older

3. Be capable of understanding and willing to comply with the conditions of the protocol
or have a legal guardian who is capable of understanding and complying with the
conditions of the protocol

4. Have read, understood, and documented written informed consent/assent

5. Be able to provide medical evidence through prior medical history of previous
inhibitor levels

6. Be willing and able to use the ATHN mobile application or a paper diary to document
BEs and medication usage


Exclusion Criteria:


1. Have a disorder of hemostasis in addition to Hemophilia A or B

2. Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its
ingredients

3. Have a known allergy or hypersensitivity to rabbits or rabbit proteins

4. Are receiving prophylactic treatment for bleeding with a drug or biologic that is not
approved for this use by the FDA

5. Have had implantation of an investigational medical device within the prior 6 months

6. Have received an investigational drug within 30 days of the baseline visit

7. Have an elective surgical procedure planned during the duration of their participation
in the study*

8. Have any life-threatening disease, or other disease or condition which, in the
investigator's judgment, could pose a potential hazard to the patient or interfere
with study participation or study outcome (e.g., a history of non responsiveness to
bypassing products or thromboembolic disease)

- Should a participant require an unplanned surgery, the participant will not be
withdrawn from the study unless the investigator deems it necessary. Instead, the
participant will receive standard of care treatment as determined by the
attending physician. If the participant is not withdrawn from the study, the
participant's participation in the study will be paused until the investigator
feels it is safe for them to continue.

 

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

Eligibility last updated 9/21/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

TORNIER PERFORM™ Stemless Reverse IDE Study (TORNIER PERFORM™ Stemless Reverse IDE Study)

TORNIER PERFORM™ Stemless Reverse IDE Study

Joaquin Sanchez-Sotelo
All
18 years and over
Post Market
This study is NOT accepting healthy volunteers
2022-306965-P01-RST
22-000653
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Inclusion Criteria:

  • Adult subject 18 years or older.
  • Scapula and proximal humerus must have reached skeletal maturity.
  • Clinical indication for reversed TSA due to: non-inflammatory degenerative joint disease (i.e., osteoarthritis), avascular necrosis, pseudoparalysis or anterior superior escape, functional deformity, post-traumatic arthritis, and/or rotator cuff tear arthropathy.
  • Willing and able to comply with the protocol.
  • Willing and able to sign the informed consent form.
  • Patients with an adjusted Constant Score ≤ 65.


Exclusion Criteria:

  • Active local or systemic infection, sepsis, or osteomyelitis.
  • In the opinion of the clinician, there is inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
  • In the opinion of the clinician, there is poor bone quality where there could be a considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
  • In surgeon’s opinion, rotator cuff tear requires a latissimus dorsi transfer.
  • In the clinician’s opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional.
  • Metabolism disorder that could compromise bone formation, or Osteomalacia.
  • Rapid destruction of the joint, marked bone loss, or bone resorption apparent on imaging.
  • Known allergy or suspected allergy to the materials.
  • Female subjects who are pregnant or planning to become pregnant within the study period.
  • Medical condition(s) or balance impairments that could lead to falls (e.g., epilepsy not well-controlled with medication, Multiple Sclerosis, etc).
  • Previous failed arthroplasty.
  • Nonfunctional deltoid muscle.
  • Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint).
  • Known active metastatic or neoplastic disease, Paget’s disease or Charcot’s disease.
  • Currently, or within the last six months, or planning to be on chemotherapy or radiation.
  • Recent or ongoing alcohol or drug abuse as determined by the investigator.
  • Taking > 5mg/day corticosteroids (e.g., prednisone), excluding inhalers and one-time injections, within three months before surgery.
  • Currently enrolled in any clinical research study that might interfere with the current study.
  • Known history of severe depression.
  • Primary insurance is Workers’ Compensation.
  • The study has completed 109 implant attempts for the randomized treatment arm.
  • Sequela of proximal humerus trauma requiring greater tuberosity osteotomy during RSA.
  • Chronic shoulder dislocation with or without fracture, > 6 weeks.
  • Parkinson’s disease.

Eligibility last updated 1/21/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Placental inflammation and function – in vitro analysis

Placenta Study

Sylvie Girard
Female
18 years to 50 years old
This study is NOT accepting healthy volunteers
2022-307202-H01-RST
22-000892
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Inclusion Criteria:

  • Women who will give birth at Mayo Clinic by caesarean-section at term following an uncomplicated pregnancy.


Exclusion Criteria:

  • Multiple pregnancy.
  • Known presence of clinical infections (e.g., chorioamnionitis), congenital anomalies or maternal pathologies (i.e., diabetes, hypertension, preeclampsia).
  • Intrauterine growth retardation or fetal macrosomia.
  • Maternal age under 18 or over 50.
  • Maternal body mass index (BMI) of less than 18 and more than 40.
  • Pregnancy less than 37 weeks of completed gestation.

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

 

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Mayo Clinic — Rochester, MN

D8534C00001 SERENA-6: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study (SERENA-6)

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Matthew Goetz
All
18 years to 130 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-305549-P01-RST
21-010873
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INCLUSION CRITERIA:

INFORMATION FOR TRIAL PARTICIPANTS
•Participants can join the trial if they:

- Have advanced breast cancer that is not able to be treated with surgery or radiation;

- Have an ESR1 mutation in their cancer;

- Have breast cancer that is HR-positive and HER2-negative;

- Are currently being treated with a CDK4/6 inhibitor and an AI and have been taking
these drugs for at least 6 months;

- Have not had their cancer get worse after taking an AI and CDK4/6 inhibitor;

- Are able to do their daily activities;

- Are at least 18.

Full list of inclusion criteria:

- Proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally
recurrent or metastatic disease not amenable to resection or radiation therapy with
curative intent;

- Documentation of histologically confirmed diagnosis of estrogen receptor positive
(ER+) /HER2- breast cancer based on local laboratory results;

- Currently on AI (letrozole or anastrozole) + CDK4/6 inhibitor (palbociclib or
abemaciclib) ± LHRH as the initial endocrine based treatment for advanced disease;

- Eastern Cooperative Oncology Group performance status of 0 or 1;

- ESR1m detected by central testing of ctDNA;

- Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures;

- Adequate organ and marrow function.

EXCLUSION CRITERIA:

INFORMATION FOR TRIAL PARTICIPANTS
•Participants cannot join the trial if they:

- Had certain types of tumors in the past that may come back;

- Are currently taking any other treatments for their cancer or other conditions
including hormone replacements, medications, or supplements that could interfere with
the trial treatment;

- Have or have had any major health problem, infection, or recent surgery that could
make it difficult or dangerous to participate in this trial.

Full list of exclusion criteria:

- Advanced, symptomatic, visceral spread, that are at risk of life-threatening
complications in the short term;

- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or
leptomeningeal disease;

- Any evidence of severe or uncontrolled systemic diseases which, in the investigator's
opinion, makes it undesirable for the participant to participate in the study or that
would jeopardize compliance with the protocol;

- Patient with known or family history of severe heart disease;

- Previous treatment with AZD9833, investigational SERDs or fulvestrant;

- Currently pregnant (confirmed with positive pregnancy test) or breastfeeding;

- Persistent non-haematological toxicities (CTCAE Grade > 2) caused by CDK4/6 inhibitor
and/or AI treatment

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

Eligibility last updated 5/31/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

First in Human Study of TORL-1-23 in Participants With Advanced Cancer (TRIO049)

All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05103683
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Inclusion Criteria:

• Advanced solid tumor
• Measurable disease, per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate organ function
Exclusion Criteria:

• Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
• Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23
• Progressive or symptomatic brain metastases
• Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
• History of significant cardiac disease
• History of myelodysplastic syndrome (MDS) or AML
• History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
• If female, is pregnant or breastfeeding
Drug: TORL-1-23
Advanced Solid Tumor, Ovarian Cancer, Endometrial Cancer, NSCLC
claudin6
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University of Minnesota — Minneapolis, Minnesota Boris Winterhoff, MD, PhD

Theta Phase-specific TMS to Modulate Prefrontal Activity

All
18 Years to 65 Years old
N/A
This study is also accepting healthy volunteers
NCT05416138
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Inclusion Criteria:
1. Age between 18 and 65 years old. 2. Confident level of English language.
Exclusion Criteria:
1. Chronic condition that requires pharmacological treatment over the course of study participation. 2. Metallic or electric implant in the head, neck, or chest area or otherwise MRI-noncompatible implants. 3. History or evidence of seizures, head injuries with loss of consciousness, chronic neurological or mental disorder. 4. Pregnancy or breast-feeding. 5. History or evidence of alcohol or drug addiction.
Device: Transcranial magnetic stimulation (TMS)
Approach/Avoidance Behavior
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University of Minnesota — Minneapolis, Minnesota Ivan Alekseichuk, PhD - (ialeksei@umn.edu) Alexander Opitz, PhD - (aopitz@umn.edu)

Vyvanse in Children Aged 6 to 12 Years

All
6 Years to 12 Years old
Early Phase 1
This study is also accepting healthy volunteers
NCT05416125
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Inclusion Criteria:

• Children ages 6 to <12 years at study entry
• Severe obesity defined as BMI >/= 1.2 times the 95th percentile
• Prior failed attempt of lifestyle therapy per parent/guardian report
• Written informed consent of parent/legal guardian and written assent of participant
Exclusion Criteria:

• Contraindications to lisdexamfetamine, including current or recent (< 14 days) use of monoamine oxidase inhibitor and known hypersensitivity to amphetamine products
• Family history of sudden death or ventricular arrhythmia
• Clinically significant congenital or structural heart disease or arrhythmia
• Hypertension defined as systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) >/= 95th percentile
• Tachycardia defined heart rate (HR) >/= 120 bpm
• Current or recent (< 3 months) use of psychostimulant or sympathomimetic amine
• History of chemical dependency
• Positive urine drug screen
• Diabetes mellitus (type 1 or 2)
• Current or recent (< 3 months) use of anti-obesity medication(s)
• Previous bariatric surgery
• Recent initiation or change in dose (< 3 months prior) of anti-hypertensive or lipid medication(s)
• Thyroid stimulating hormone (TSH) > 1.5x upper limit of normal (ULN)
• Aspartate transaminase (AST) or alanine transaminase (ALT) > 3x ULN
• Fasting glucose >/= 126 mg/dL
• History of mania, schizophrenia, bipolar disorder, or psychosis
• Unstable depression or anxiety that has required hospitalization in the past 12 months
• Any history of suicide attempt
• Columbia Suicide Severity Rating Scale (C-SSRS) of type 4 or 5 in past month
• Children's Depressive Inventory 2 (CDE-2_ score >/= 70
• Concomitant use of tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs), serotonin and norepinephrine re-uptake inhibitors (SNRIs), lithium, fentanyl, tramadol, triptans, tryptophan, buspirone and St. John's wort
• Refusal to use adequate contraception (double barrier method or stable hormonal contraception plus single barrier method, tubal ligation, or abstinence) in girls of childbearing potential
Drug: Lisdexamfetamine Dimesylate, Behavioral: Lifestyle therapy
Obesity, Childhood
Obesity
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University of Minnesota — Minneapolis, Minnesota Claudia Fox, MD - (lusc0001@umn.edu) Lisa Hostetler, BA - (hoste005@umn.edu)

A Phase 1/2, Dose Escalation, Dose Expansion, and Dose Optimization Study of the Safety, Tolerability, and Anti-tumor Activity of SAR444881 Administered Alone and in Combination With Pembrolizumab, Cetuximab and/or Chemotherapy in Participants With Advanced Solid Tumors

An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of SAR444881 in Patients with Advanced Solid Tumors

Zhaohui Jin
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-303665-P01-RST
21-001327
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Inclusion Criteria:


- Patients with unresectable or metastatic disease who are refractory to or are not
candidates for standard approved therapy

- Histologic confirmation of malignancy

- Measurable disease per RECIST v1.1

- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1

- Participants must have adequate organ function as defined by lab tests

- Part 1: Following tumor types: Breast cancer, cervical cancer, colorectal cancer,
adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or
gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and
neck, hepatobiliary cancers (hepatocellular carcinoma (HCC), gallbladder cancer,
cholangiocarcinoma), non-small cell lung cancer, renal cell carcinoma, squamous cell
carcinoma of the skin, or urothelial carcinoma

- Part 2: Following tumor types: Squamous cell carcinoma of the head and neck, Gastric
or gastroesophageal junction adenocarcinoma, Non-small cell lung cancer


Exclusion Criteria:


- Active, known or suspected autoimmune disease

- Condition requiring systemic treatment with either corticosteroids or other
immunosuppressive medications

- Brain or leptomeningeal metastases

- Known history of positive test for HIV

- Non-HCC patients: acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV);
HCC patients: untreated active HBV or dual infection with HBV/HCV

- Participants after solid organ or allogeneic hematopoietic stem cell transplant

- History of life-threatening toxicity related to prior immune therapy

- History of life-threatening toxicity related to prior cetuximab or other anti-EGFR
antibodies (for Sub-Part 1C)

- Unstable or deteriorating cardiovascular disease within the previous 6 months

- Any major surgery within 4 weeks of study drug administration

- Prior/Concomitant Therapy:

- Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from
last dose

- Use of other investigational drugs within 28 days

- Prior treatment with macrophage or natural killer (NK) cells activating therapies

- Administration of a live attenuated vaccine within 28 days

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

Eligibility last updated 11/9/22. Questions regarding updates should be directed to the study team contact.

Drug, Biologic/Vaccine
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Mayo Clinic — Rochester, MN

Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia (SCOPE-L)

Specialty Compared to Oncology Delivered Palliative Care for Treating Acute Myeloid Leukemia

Jacob Strand
All
18 years to 120 years old
Not Applicable
This study is NOT accepting healthy volunteers
2022-306867-P01-RST
22-000288
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Inclusion Criteria
•Patient:

  • Hospitalized patients (age ≥ 18 years) with high-risk AML defined as:
    • Patients with new diagnosis ≥ 60 years of age;
    • An antecedent hematologic disorder;
    • Therapy related-disease;
    • Relapsed or primary refractory AML.
  • Receiving treatment with either:
    • intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen requiring prolonged hospitalization; or
    • hypomethylating agents +/- additional agents or modification of this regimen on a clinical trial.

Inclusion Criteria
•Caregiver:

  • Adult (≥ 18 years) relative or friend of a participating patient who the patient identifies as living with or has in-person contact with them at least twice per week.

Exclusion Criteria
•Patient:

  • Patients with a diagnosis of acute promyelocytic leukemia (APML).
  • Patients with AML receiving supportive care alone.
  • Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures.
  • Patients seen by a palliative care clinician [MD or APP] during two hospitalizations in the six months prior to enrollment.

Eligibility last updated 11/27/23. Questions regarding updates should be directed to the study team contact.

 

Behavioral
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Mayo Clinic — Rochester, MN

The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer (MNCCTN023)

The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer

Stephan Thome
Female
18 years and over
This study is NOT accepting healthy volunteers
2022-306982-P01-MAIJ
22-000839
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Ability to read and write in English.
  • Women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer.
  • Treatment plan includes chemotherapy.
  • Able to provide written voluntary consent before performance of any study related procedure.
  • Aim 1 only: after completion of initial chemotherapy.
  • Aim 2 only: prior to starting chemotherapy.


Exclusion Criteria:

  • Inability to provide informed consent.
  • Exposure to chemotherapy prior to ovarian cancer diagnosis.
  • Life expectancy < 3 months or in hospice care or nursing home.
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Mayo Clinic Health System — Mankato, MN

Evaluation of a Wearable Physiologic Monitor to Detect Sleep Quality

Evaluate Sleep Quality from Wearable Physiologic Monitor

Timothy Morgenthaler
All
19 years and over
This study is NOT accepting healthy volunteers
2022-308005-H01-RST
22-004369
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Inclusion Criteria:

  • Adults  > 18 years of age.
  • Body-Mass Index (BMI) < 35.
  • Normal sleep routine (typically awake during day and asleep at night).


Exclusion Criteria:
 

  • Prior diagnosis of, or positive STOP-BANG screen (> 3) for sleep apnea.
  • Excessive daytime sleepiness (the recorded Epworth Sleepiness Scale (ESS) must be ≤ 9).
  • History of heart failure, atrial fibrillation, pulmonary, neurological, or psychiatric disease.
  • Currently being treated pharmacologically for depression or other significant medical condition (broadly speaking).
  • Subject is receiving hypnotics or stimulant medication.
  • Habitual use of 3 or more cups of coffee/caffeinated tea per day.
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Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (“APS ACTION”) International Clinical Database and Repository (APS ACTION)

Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION)

Ali Duarte Garcia
All
18 years to 75 years old
This study is NOT accepting healthy volunteers
2021-304223-P01-RST
20-006195
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Inclusion Criteria:

  • Age 18-75.
  • Persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to the screening defined as: o aCL IgG/M/A (> 40U, medium-to-high titer, and/or greater than the 99th percentile) and/or o aβ2GPI IgG/M/A (>40U, medium-to-high titer, and/or greater than the 99th percentile) and/or o Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations.


Exclusion Criteria:

  • Patient refusal.
  • Inability to comply with study and follow-up procedures.
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Mayo Clinic — Rochester, MN

Starstim: Safety and Therapeutic Measures of Transcranial Cathodal Direct Current Stimulation (TDCS) in Patients with Refractor Focal Epilepsy (Starstim)

Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

Brian Lundstrom
All
9 years and over
Not Applicable, Pivotal
This study is NOT accepting healthy volunteers
2021-305228-P01-RST
21-008120
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Inclusion Criteria:


1. 9 years old or older

2. Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic
clonic seizures (International League Against Epilepsy classification). Diagnosis
established by both clinical history and an electroencephalogram (EEG) consistent with
focal seizures. Note: A normal interictal EEG is consistent with focal seizures if
other data is adequate to provide localization.

3. Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure
control despite demonstrated compliance, according to medical records, on at least two
(2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's
demographic according to package labeling, within approximately the last 3 years.

4. Seizure frequency >= 3 per month over the past year.

5. Currently on at least 1 ASD, with no changes in antiepileptic drug doses in the 3
weeks prior to baseline visit in the study and no planned dose changes during the
trial. Changes after baseline visit are permitted only if clinically necessary.

6. An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR
sequences, performed within the past 3 years and more recently than any craniotomy or
skull burr hole procedure.

7. Seizure focus that allows design of an appropriate stimulation montage Note: Seizure
focus can be identified within a lobe, or 2 adjacent lobes. Identification of the
border of the seizure focus can be approximate (+/- 2 gyri).

8. Available seizure history and supporting data

9. All female study subjects of child-bearing age are required to have a pregnancy test.
Additionally, all females of childbearing potential will be required to use an
effective method of birth control (defined as having a documented failure rate of ≤1%;
for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as
effective).

10. Written informed consent obtained from study subject or subject's legal representative
and ability for study subject to comply with the requirements of the study.

11. Assent from pediatric subjects when appropriate.


Exclusion Criteria:


1. Presence of a condition or abnormality that in the opinion of the Investigator would
compromise the safety of the subject or the integrity of the data.

2. Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is
defined as a cortical region confined to one hemisphere and either one lobe or on a
junction of two adjacent lobes from which seizures arise, as documented by scalp or
intracranial EEG, that is either supported or not refuted by MRI, and either supported
or not refuted by clinical semiology). If the interictal EEG is normal, a seizure
focus may be identified by the combination of structural findings on MRI and clinical
signs/symptoms associated with the subject's seizures.

3. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal

4. Seizure focus is hemispheric or poorly defined

5. History of psychogenic non-epileptic seizures in past 2 years, or physiologic
nonepileptic seizures and non-epileptogenic events, including suspicion for or a
significant history of syncope, and any non-epileptic events must be clearly
differentiable from subject's focal seizures based on previously recorded video EEG
showing distinct clinical and electrographic features of the subject's PNES compared
to their epileptic seizures.

6. Seizures of generalized onset

7. Status epilepticus in the last 12 months

8. Presence of any disease, medical condition or physical condition that, in the opinion
of the Investigator, may compromise interfere, limit, affect or reduce the subject's
ability to complete a study of 24 weeks duration.

9. Presence of any disease, medical condition or physical condition that, in the opinion
of the Investigator, may adversely impact the safety of the subject or the integrity
of the data.

10. Damaged skin on scalp that may interfere with tDCS stimulation.

11. Pregnant, or unwilling to practice birth control during participation in the study.

12. Nursing mothers.

13. Any cranial metal implants (excluding ?1 mm thick epicranial titanium skull plates and
dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator,
medication infusion pump, cochlear implant, vagus nerve stimulator).

14. Previous surgeries opening the skull leaving skull defects capable of allowing the
insertion of a cylinder with a radius greater or equal to 5 mm.

15. A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use
of any illicit substance.

 

Eligibility last updated 7/1/22]. Questions regarding updates should be directed to the study team contact.

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MC210705 Phase 1 Study of the Administration of STI-3031 (anti-PDL1) Intra-Lymphatically Using the Sofusa® DoseConnect™ DEVICE in Patients with In-Transit Melanoma (Sofusa 2)

STI-3031 Through Sofusa DoseConnect for Treatment of Intransit Melanoma

Anastasios Dimou
All
18 years and over
Phase 1, Feasibility
This study is NOT accepting healthy volunteers
2021-305509-P01-RST
21-010150
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Registration –

Inclusion Criteria:

  • Age ≥ 18 years.
  • Newly diagnosed, recurrent, or previously treated in-transit metastatic melanoma (ITM) confined to a single limb.
  • Regional involvement of the inguinal (lower limb) and axillary (upper limb) lymph nodes is permitted.
  • One of the following must be true:
    • A visible superficial ITM, non-nodal lesion with longest diameter ≥ 0.2 cm in diameter as assessed using a ruler (e.g., skin nodules). Documentation by color photography, including a ruler is required;
    • A malignant regional lymph node with short axis > 1.0 cm as assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm);
    • A non-visible, non-nodal soft tissue mass of the involved extremity with longest diameter ≥1.0 cm as measured with CT scan, CT component of a PET/CT, or MRI.
  • The following laboratory values obtained ≤ 15 days prior to registration:
    • Hemoglobin ≥ 8.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥ 75,000/mm^3;
    • Total bilirubin ≤ 1.5 × ULN;
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3.0 × ULN;
    • Serum creatinine ≤ 2.0 × ULN;
    • Calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula;
    • PT/INR/aPTT ≤ 1.5 × ULN
      OR if patient is receiving anticoagulant therapy INR or aPTT is within target range of therapy.
  • ECOG Performance Status (PS) 0 or 1.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
  • Persons able to become pregnant OR able to father a child must be willing to use an adequate method of contraception while on treatment and for 180 days (6 months) after last treatment dose on this study.
  • Provide written informed consent.
  • Willingness to provide mandatory blood specimens for correlative research.
  • Willing to return to enrolling institution for 3-month follow-up (during the Active Monitoring Phase of the study).

Registration


Exclusion Criteria:

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception;
    • Persons expecting to conceive or father children during the study or within 180 days (6 months) after the last treatment on this study.
  • Metastatic melanoma beyond in-transit metastases (ITM) and regional lymph nodes (LNs).
  • ITM involving the hands and feet (not accessible to DoseConnect infusion).
  • ITM NOT involving a limb (i.e., head, neck, or trunk).
  • Prior radiation of ITM that are being evaluated as measurable lesions.
  • Any of the following prior therapies:
    • Allogeneic hematopoietic stem cell transplantation (HSCT);
    • Solid organ transplantation.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
    • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Active autoimmune disease requiring systemic treatment < 2 years prior to registration, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents with use of disease modifying agents, corticosteroids, or immunosuppressive drugs.
    • NOTE: Exceptions are allowed for the following conditions:
    • Vitiligo;
    • Resolved childhood asthma/atopy;
    • Intermittent use of bronchodilators or inhaled steroids;
    • Daily steroids at dose of ≤ 10mg of prednisone (or equivalent);
    • Local steroid injections;
    • Stable hypothyroidism on replacement therapy;
    • Stable diabetes mellitus on therapy (with or without insulin);
    • Sjögren’s syndrome;
    • Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) which is not considered a form of systemic treatment and is allowed.
  • Uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection requiring systemic therapy;
    • Interstitial lung disease;
    • Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn’s disease or others);
    • Known history of hepatitis B (i.e., known positive HBV surface antigen (HBsAg) reactive);
    • Known active hepatitis C (i.e., positive for HCV RNA detected by PCR);
    • Known active tuberculosis (TB);
    • Symptomatic congestive heart failure;
    • Unstable angina pectoris;
    • Unstable cardiac arrhythmia; or
    • Psychiatric illness/social situations that would limit compliance with study requirements (e.g., known substance abuse).
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • History of severe hypersensitivity reactions to other monoclonal antibodies or known hypersensitivity to the study intervention or its excipients, indocyanine green (ICG) dye or iodine.
  • Prior history of Grade 4 immune related adverse event (irAE) with prior ICI therapy or failure to recover (< Grade 1) from immune-related adverse event(s) from prior ICI therapy.
  • Any of the following therapies prior to registration:
    • Chemotherapy ≤ 21 days;
    • Immunotherapy ≤ 21 days;
    • Targeted therapies (e.g., dabrafenib) ≤ 21 days;
    • Other investigational agents ≤ 28 days;
    • Radiation therapy ≤ 14 days;
    • Minor surgical or interventional procedure ≤ 7 days, (biopsy of same limb for diagnosis allowed);
    • Major surgical procedure ≤ 21 days.

Eligibility last updated 12/17/21. Questions regarding updates should be directed to the study team contact.

Combination Product, Device, Drug
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An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome

Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

Irina Bancos
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2022-307253-P01-RST
22-001433
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Inclusion Criteria:
 

  • Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
  • According to the Investigator's opinion, will benefit from continuing treatment with relacorilant.


Exclusion Criteria:

  • Premature discontinuation from a relacorilant parent study.
  • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
  • Has poorly controlled hypertension.
  • Has Stage ≥ 4 renal failure.

Eligibility last updated 2/8/22. Questions regarding updates should be directed to the study team contact.

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MC198B, Phase II Study of a Combination Therapy of Acalabrutinib, Venetoclax and Durvalumab in Patients with Richter Transformation from Chronic Lymphocytic Leukemia (CLL)

Combination Therapy of Acalabrutinib, Venetoclax and Durvalumab to Treat Richter Transformation

Paul Hampel
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101230-P01-RST
20-006487
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Inclusion Criteria:


- Age >= 18 years willing to provide consent and follow-up

- Diagnosis of CLL according to the International Workshop on Chronic Lymphocytic
Leukemia (IWCLL) 2018 criteria (Hallek et al., 2018) or small lymphocytic lymphoma
(SLL) according to the World Health Organization (WHO) 2008 criteria (Harris, 1999).
This includes previous documentation of:

- Biopsy-proven SLL according to WHO 2008 criteria, or

- Diagnosis of CLL according to IWCLL 2018 criteria as evidenced by all of the
following:

- Peripheral blood B cell count of >= 5 x 10^9/L consisting of small to
moderate size lymphocytes (If there are enough evidence to document the
prior diagnosis of CLL, it is not required to meet the criteria of
peripheral blood B cell count more than 5 x 10^9/L )

- Immunophenotyping consistent with CLL defined as:

- The predominant population of lymphocytes share both B-cell antigens
(CD19, CD20 [typically dim expression], or CD23) as well as CD5 in the
absence of other pan-T-cell markers (CD3, CD2, etc.)

- Clonality as evidenced by kappa or lambda light chain expression
(typically dim immunoglobulin expression) or other genetic method (e.g.
immunoglobulin heavy chain variable [IGHV] analysis)

- NOTE: Splenomegaly, hepatomegaly, or lymphadenopathy are not
required for the diagnosis of CLL

- Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by
demonstrating a negative fluorescence in situ hybridization (FISH) analysis
for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy or negative
immunohistochemical stains for cyclin D1 on involved tissue biopsy

- If prior CLL diagnosis was confirmed, or CLL diagnosis was confirmed on bone
marrow examination or tissue biopsy, peripheral blood B cell count less than
5 x 10^9/L is allowed

- Biopsy proven Richter's transformation of the CLL

- NOTE: Previously treated patients including CLL therapy can be enrolled. If
Richter's transformation (RT) developed from prior untreated CLL and has not
received any RT directed therapy, then patient is not eligible

- Richter patients with prior or concurrent CLL diagnosis and do not have other option
for standard therapy per treating physician's discretion

- Measurable disease can be detected in positron emission tomography (PET) or computed
tomography (CT) (>= 1 cm in diameter)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2

- Absolute neutrophil count >= 0.7 x 10^9/L unless marrow was involved by CLL or RT,
then absolute neutrophil count (ANC) >= 0.3 x 10^9/L (=< 14 days prior to
registration)

- Platelet count >= 40 x 10^9/L unless marrow was involved by CLL or RT, then platelet
>= 30 x 10^9/L without transfusion =< 1 week prior to study registration (=< 14 days
prior to registration)

- Hemoglobin (Hgb) >= 8 unless marrow was involved by CLL or RT, then Hgb >= 7 without
transfusion =< 1 week prior to study registration (=< 14 days prior to registration)

- Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to confirmed Gilbert's
disease (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated
in the absence of hemolysis or hepatic pathology), who will be allowed only in
consultation with their physician (=< 14 days prior to registration)

- Note: If total bilirubin is > 1.5 x ULN, a direct bilirubin should be performed
and must be =< upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or
alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X
ULN unless liver metastases are present, in which case it must be =< 5 x ULN (=< 14
days prior to registration)

- Calculated creatinine clearance of > 30 mL/min by the Cockcroft-Gault formula
(Cockcroft and Gault 1976) (=< 14 days prior to registration)

- Negative pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only

- NOTE: The following restrictions apply while the patient is receiving study
treatment and for the specified times before and after:

- Female patient of child-bearing potential

- Female patients of childbearing potential who are not abstinent and
intend to be sexually active with a non sterilized male partner must
use at least 1 highly effective method of contraception from the time
of screening throughout the total duration of the drug treatment and
the drug washout period (180 days after the last dose of study
treatment). Non-sterilized male partners of a female patient of
childbearing potential must use male condom plus spermicide throughout
this period. Cessation of birth control after this point should be
discussed with a responsible physician. Periodic abstinence, the rhythm
method, and the withdrawal method are not acceptable methods of birth
control. Female patients should also refrain from breastfeeding
throughout this period

- Male patients with a female partner of childbearing potential

- Non-sterilized male patients who are not abstinent and intend to be
sexually active with a female partner of childbearing potential must
use a male condom plus spermicide from the time of screening throughout
the total duration of the drug treatment and the drug washout period
(180 days after the last dose of study treatment). However, periodic
abstinence, the rhythm method, and the withdrawal method are not
acceptable methods of contraception. Male patients should refrain from
sperm donation throughout this period

- Female partners (of childbearing potential) of male patients must also use a
highly effective method of contraception throughout this period

- Females of childbearing potential are defined as those who are not
surgically sterile (i.e., bilateral salpingectomy, bilateral oophorectomy,
or complete hysterectomy) or post-menopausal

- Women will be considered post-menopausal if they have been amenorrheic for
12 months without an alternative medical cause. The following age-specific
requirements apply:

- Women < 50 years of age would be considered post-menopausal if they
have been amenorrheic for 12 months or more following cessation of
exogenous hormonal treatments and if they have luteinizing hormone and
follicle-stimulating hormone levels in the post-menopausal range for
the institution

- Women >= 50 years of age would be considered post-menopausal if they
have been amenorrheic for 12 months or more following cessation of all
exogenous hormonal treatments, had radiation-induced menopause with
last menses > 1 year ago, had chemotherapy-induced menopause with last
menses > 1 year ago

- Highly effective methods of contraception, defined as one that results in a
low failure rate (i.e., less than 1% per year) when used consistently and
correctly are described below. Note that some contraception methods are not
considered highly effective (e.g. male or female condom with or without
spermicide; female cap, diaphragm, or sponge with or without spermicide;
non-copper containing intrauterine device; progestogen-only oral hormonal
contraceptive pills where inhibition of ovulation is not the primary mode of
action [excluding Cerazette/desogestrel which is considered highly
effective]; and triphasic combined oral contraceptive pills)

- Effective methods include:

- Copper T intrauterine device

- Levonorgestrel-releasing intrauterine system (e.g., Mirena)

- Implants: Etonogestrel-releasing implants: e.g. Implanon or Norplant

- Intravaginal: Ethinylestradiol/etonogestrel-releasing intravaginal
devices: e.g. NuvaRing

- Injection: Medroxyprogesterone injection: e.g. Depo-Provera

- Combined pill: Normal and low dose combined oral contraceptive pill

- Patch: Norelgestromin/ethinylestradiol-releasing transdermal system:
e.g. Ortho Evra

- Minipill: Progesterone based oral contraceptive pill using desogestrel:
Cerazette is currently the only highly effective progesterone-based

- Tubal ligation

- Provide informed written consent

- Willing to return to Mayo Clinic enrolling institution for follow-up

- Willing to provide tissue, blood, and bone marrow samples for mandatory correlative
research purposes


Exclusion Criteria:


- Any of the following uncontrolled intercurrent illness:

- Clinically significant cardiovascular disease such as:

- Symptomatic arrhythmias

- Congestive heart failure

- Myocardial infarction =< 3 months prior to registration

- Any class 3 or 4 cardiac disease as defined by the New York Heart
Association functional classification

- Uncontrolled hypertension

- Unstable angina pectoris

- Note: Subjects with controlled, asymptomatic atrial fibrillation can
enroll on study

- Serious chronic gastrointestinal conditions associated with diarrhea

- History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)

- History of stroke or intracranial hemorrhage within 6 months before first dose of
study drug

- History of bleeding diathesis (e.g., hemophilia, von Willebrand disease)

- Active uncontrolled infection (e.g., bacterial, viral or fungal, including
subjects with positive cytomegalovirus [CMV] deoxyribonucleic acid [DNA]
polymerase chain reaction [PCR]) requiring systemic therapy. NOTE: When the
infection is controlled with systemic therapy, patients are permitted for this
study

- Active tuberculosis infection (clinical evaluation that includes clinical
history, physical examination and radiographic findings, and tuberculosis [TB]
testing in line with local practice)

- Known human immunodeficiency virus (HIV/acquired immunodeficiency syndrome
[AIDS]) infection as further severe immunosuppression with this regimen may occur

- Hepatitis B or C serologic status:

- Hepatitis B surface antigen and hepatitis B PCR positive will be excluded

- Hepatitis B core antibody (anti-HBc) positive and who are surface antigen
negative, and hepatitis B PCR positive will be excluded

- These above patients once treated for hepatitis B and became hepatitis B PCR
negative, they will be eligible

- Hepatitis C PCR positive will be excluded. Once treated and hepatitis C PCR
negative will be eligible

- NOTE: Once patients with active hepatitis treated with effective therapy and
adequate disease control, they will be allowed for participation

- Any of the following because this study involves an investigational agent whose
genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown

- Pregnant women

- Nursing women

- Men and women of childbearing potential who are unwilling to employ highly
effective method of contraception starting with the screening visit through 180
days after the last dose of trial treatment

- Treated with other active investigational agents (excluding venetoclax, acalabrutinib.
or ibrutinib) =< 5 half -lives of the previous investigational agents, please consult
study chair for the specific investigational agent

- Prior durvalumab treatment. Note: If patients were treated with other prior PD1
blockade or PDL1 blockade, they will still be eligible

- Active or recent (=< 2 months) documented autoimmune or inflammatory disorders
(including inflammatory bowel disease [e.g., colitis or Crohn's disease],
diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus,
Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves'
disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]) not being controlled.
Exceptions:

- Patients with vitiligo or alopecia

- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on
hormone replacement

- Any chronic skin condition that does not require systemic therapy

- Patients without active disease in the last 3 years may be included but only
after consultation with the study physician

- Patients with celiac disease controlled by diet alone

- Evidence of interstitial lung disease or active, non-infectious pneumonitis

- Known psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the trial

- Active central nervous system (CNS) lymphoma or cerebrospinal fluid involvement with
malignant lymphoma cells that requires therapy

- Clinically significant coagulopathy per investigator's assessment (stable
anticoagulation except warfarin or other vitamin K antagonist will be allowed)

- Received an allogenic stem cell transplant within the last 2 years; Or prior history
of allogeneic stem cell transplant with history of graft versus host disease (GVHD)

- Active chronic GVHD requiring treatment

- Chronically taking a strong CYP3A inhibitor or inducer and moderate inducer and cannot
be switched to an alternative agent at least 4 days prior to trial therapy initiation
that in the opinion of investigator/treating physicians precludes utilization of trial
therapy

- Patients taking proton pump inhibitor will be excluded. NOTE: Patient may be switch to
an H2 blocker or antiacid

- History of another primary malignancy except for:

- Malignancy treated with curative intent and with no known active disease >= 5
years before the first dose of study drug and of low potential risk for
recurrence

- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease

- Adequately treated carcinoma in situ without evidence of disease

- Indolent malignancy with expected life expectancy more than 2 years

- Current or prior use of immunosuppressive medication =< 5 half-lives of previous
immunosuppressive medication. The following are exceptions to this criterion:

- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra
articular injection)

- Systemic corticosteroids at physiologic doses not to exceed =< 30 mg/day of
prednisone or its equivalent

- Steroids as premedication for hypersensitivity reactions (e.g., CT scan
premedication)

- Receipt of live attenuated vaccine =< 30 days prior to registration. Note:
Patients, if enrolled, should not receive live vaccine whilst receiving
investigational product (IP) and up to 30 days after the last dose of IP

- Any radiation therapy =< 1 week prior to registration

- Any major surgery =< 28 days prior to registration (Note: Routine tissue or nodal
biopsy or small procedures typically heal fast will not be counted as surgery)

- Body weight =< 30 kg

- Life expectancy < 12 weeks

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

Eligibility last updated 7/17/23. Questions regarding updates should be directed to the study team contact.

Drug
Cancer, Chronic lymphocytic leukemia, Leukemia, Lymphoma, Non-Hodgkin's lymphoma
Cancer treatment, Chemotherapy, Chronic lymphoid leukemia, disease, Durvalumab [USAN:INN], Hematopoietic system, Malignant lymphoma - small lymphocytic, Medical Oncology, Richter's syndrome, acalabrutinib, durvalumab, venetoclax, 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide, Acalabrutinib [USAN:INN]
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ALSENLITE: An Open-label Pilot Study of Senolytics for Alzheimer's Disease (ALSENLITE)

ALSENLITE: Senolytics for Alzheimer's Disease

Vijay Ramanan
All
55 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-122031-P01-RST
19-003394
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Inclusion Criteria:


1. Men and women of age 55 years and older at the time of enrollment

2. Clinical diagnosis of symptomatic probable AD (MMSE 26 to 15 or Short Test of Mental
Status 31 to 15 inclusive and/or Clinical Dementia Rating Scale/CDR = 0.5 to 2,
inclusive)

3. Not on cholinesterase inhibitors or memantine; or if on cholinesterase inhibitors
and/or memantine, on a stable dose for at least three months

4. Body Mass Index (BMI) within range of 19
•50 kg/ m2

5. Participants must be accompanied by a LAR designated to sign informed consent and to
provide study partner reported outcomes at all visits

6. Participants must have no plans to travel over the ~3 months between Visits 3 and 14
that interfere with study visits

7. Tau positivity by brain PET imaging

8. Adequate blood counts i.e. platelets > 50,000 per microliter; HB > 9/dL, and ANC >
1000 per microliter

9. Availability and consent from a LAR.


Exclusion Criteria:


1. Unwilling or unable to give informed consent

2. Pregnancy

3. QTc > 450 msec on baseline ECG

4. MRI contraindications

5. Presence of uncontrolled psychiatric disorder (as per clinical judgment)

6. Presence of uncontrolled systemic lupus erythematosus (as per clinical judgment)

7. Substance or alcohol abuse (current alcohol use > 3 alcoholic beverage/day or > 21 per
week and as per clinical judgment)

8. Hearing, vision, or motor deficits despite corrective devices (as per clinical
judgment)

9. Myocardial infarction, angina, stroke, or transient ischemic attack in the past 6
months

10. Chronic heart failure (as per clinical judgment)

11. Neurologic, musculoskeletal, or other condition that limits subject's ability to
complete study physical assessments (as per clinical judgment)

12. Positive SARS-CoV-2 test within 30 days prior to enrollment

13. AST/ALT > 2.5x upper limit normal

14. Presence of significant liver disease with total bilirubin > 2X upper limit or as per
clinical judgment

15. Inability to tolerate oral medication (as per clinical judgment)

16. Abnormality in any of the screening laboratory studies (see section 6.21.2) or as per
clinical judgment

17. Malabsorption (as per clinical judgment)

18. Known human immunodeficiency virus infection (as per clinical judgment)

19. Known active hepatitis B or C infection

20. Invasive fungal or viral infection (as per clinical judgment)

21. Known hypersensitivity or allergy to D or Q

22. Uncontrolled pleural/pericardial effusions or ascites (as per clinical judgment)

23. New/active invasive cancer except non-melanoma skin cancers

24. Inability to tolerate oral medications (as per clinical judgment)

25. Currently taking AND unable to safely hold any of the medications listed in Appendix 1
during the days IP is administered and for 36 hours after IP administration.

26. Uncontrolled diabetes (defined as HbA1c > 7% or as per clinical judgment).

27. Gastric bypass/reduction

28. Crohn's disease

29. Myopathies (increased or low calcium, vitamin D deficiency, elevated creatine kinase
or ESR) (as per clinical judgment)

30. eGFR < 10 ml/ min/ 1.73 m2

31. Creatinine clearance < 60 mL/min/1.73 m2

32. Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low
molecular weight heparin, factor Xa inhibitors, etc.)

33. On antiplatelet agents (e.g., full dose Aspirin, Clopidogrel etc.). Baby aspirin (81
mg), if absolutely necessary from cardiac perspective, will be allowed

34. Presence of any condition that the Investigator believes would put the subject at risk
or would preclude the patient from successfully completing all aspects of the trial

Involvement of special vulnerable populations: We will not involve special vulnerable
populations, such as fetuses, neonates, pregnant women, children, prisoners,
institutionalized individuals, or others who may be considered vulnerable populations
except for patients with dementia. Therefore, availability and consent from a LAR is an
inclusion criterion.

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

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

Behavioral, Drug
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A Phase 2a Study of TPN-101 in Patients with Progressive Supranuclear Palsy (Transposon PSP)

A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)

James Bower
All
41 years to 86 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-305123-P01-RST
21-009518
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Inclusion Criteria:

  • Probable PSP defined as meeting all 4 of the following:
    • At least a 12-month history of postural instability during the first 3 years that symptoms are present,OR at least a 12-month history of falls during the first 3 years that symptoms are present;
    • Vertical supranuclear gaze palsy defined as clear limitation of the range of voluntary gaze in the vertical more than in the horizontal plane (more than expected with age), which is overcome by activation of the vestibulo-ocular reflex (at later stages, the vestibulo-ocular reflex may be lost, or the maneuver prevented by nuchal rigidity), OR slow velocity of vertical saccades (i.e., decreased velocity (and gain) of vertical greater than horizontal saccadic eye movements).
      • Note: Gaze should be assessed by command to a stationary target rather than by pursuit, with the target >20 ° from the position of primary gaze. Typically, saccadic movement is slow enough for the examiner to see its progress, rather than just its initial and final positions. Deficits are more prominent in the vertical than the horizontal plane. A delay in initiation of saccades is not considered slowing.
    • Age at symptom onset of 40 to 85 years by history and current age between 41 and 86 years, inclusive, at the time of Screening;
    • Akinetic-rigid syndrome with prominent axial rigidity.
  • Presence of PSP symptoms for less than 5 years.
  • Body weight range of ≥ 41 kg (90 lbs) to ≤ 118 kg (260 lbs).
  • Able to perform all protocol-specified assessments, including neuropsychological tests; and comply with taking study medication and the study visit schedule, as judged by the investigator.
  • Has a reliable caregiver to accompany the patient to all study visits. Caregiver must be able to read, understand, and speak local language fluently to ensure comprehension of informed consent and informant-based assessments of the patient. Caregiver must also have frequent contact with patient (at least 3 hours per week at one time or at different times) and be willing to monitor the patient's health and concomitant medications throughout the study.
  • Score ≥ 18 on the Mini Mental State Exam (MMSE) at Screening.
  • Patient must reside outside a skilled nursing facility or dementia care facility at the time of Screening, and admission to such a facility must not be planned. Residence in an assisted living facility is allowed.
  • If patient is receiving coenzyme Q10, levodopa/carbidopa, levodopa/ benserazide, a dopamine agonist, catechol-o-methyltransferase inhibitor, other Parkinson's disease medication, or memantine with or without acetylcholinesterase inhibitors for cognition; the dose must have been stable for at least 30 days prior to Screening and must remain stable for the duration of the study. No such medication may be initiated during the study.
  • Stable on other chronic medications for at least 30 days prior to Screening.
  • If female, must be postmenopausal (for at least 2 years), surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or agree to use highly effective methods of contraception from Screening through Week 52.
  • If male, with a partner who is not postmenopausal (for at least 2 years) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), the patient must agree that he and his partner will use highly effective methods of contraception from Screening through Week 52.


Exclusion Criteria:

  • Presence of other significant neurological or psychiatric disorders including (but not limited to) Alzheimer's disease; dementia with Lewy bodies; prion disease; Parkinson's disease (which has not subsequently been revised to PSP); amyotrophic lateral sclerosis or other motor neuron disease; multiple sclerosis; any psychotic disorder; severe bipolar or unipolar depression; prior history of a suicide attempt or current suicidal thoughts or behavior that are believed to represent a safety risk as indicated by a “yes” response to Question 2 on the C-SSRS; seizure; brain tumor or other space-occupying lesion; history of stroke; or history of severe head injury within the past 20 years.
  • History of significant brain abnormality, including, but not limited to, prior hemorrhage or infarct, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma (SDH), hydrocephalus, space-occupying lesion (e.g., abscess or brain tumor such as meningioma). If there is history or evidence on neurologic exam suggesting possible SDH, patients should be fully evaluated, including magnetic resonance imaging (MRI) if indicated, to exclude significant, new SDH.
  • Presence of cerebellar ataxia, choreoathetosis, early symptomatic autonomic dysfunction, or tremor while at rest.
  • Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay.
  • Known presence of disease-associated mutation in TARDBP, GRN, CHMPB2, or VCP genes; or any other frontotemporal lobar degeneration causative genes not associated with underlying tau pathology.
  • History of deep brain stimulator surgery other than sham surgery for deep brain stimulation clinical trial.
  • History of early, prominent rapid eye movement sleep behavior disorder.
  • History of cancer within 5 years of Screening, with the exception of fully excised non-melanoma skin cancers.
  • History of clinically significant hematological, endocrine, cardiovascular, renal, hepatic, or gastrointestinal disease.
  • Uncontrolled hypertension, defined as confirmed systolic blood pressure (SBP) > 170 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg at Screening.
  • Hypotension, defined as confirmed SBP < 90 mmHg and/or DBP < 60 mmHg at Screening.
  • Any major surgery within 4 weeks of Screening.
  • Receipt of an investigational immunomodulator or monoclonal antibody within 180 days (or 5 half-lives, whichever is longer) prior to Screening.
  • Receipt of systemic corticosteroids within 30 days prior to Screening.
  • Autoimmune disease (quiescent rheumatoid arthritis, psoriasis, or controlled Type 1 diabetes are acceptable).
  • Donation of blood or serum > 500 mL to a blood bank or in a clinical study (except a Screening Visit) within 3 months of Screening.
  • Blood transfusion within 4 weeks of Screening.
  • Inability to be venipunctured and/or tolerate venous access.
  • Contraindication to undergoing a lumbar puncture (LP) including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; international normalized ratio (INR) > 1.4 or other coagulopathy; platelet count of < 120,000/μL; infection at the desired LP site; taking anti-coagulant medication within 30 days of Screening (Note: aspirin is permitted); severe degenerative arthritis of the lumbar spine; suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma; symptoms or signs of elevated intracranial pressure, e.g., symptoms or history of head injury or abnormal funduscopic exam.
  • Has smoked or used tobacco products within 6 months prior to study drug administration.
  • Within 4 weeks of Screening (first visit), concurrent treatment with antipsychotic agents or mood stabilizers (e.g., valproate, lithium) or benzodiazepines, with the following exceptions:
    • Patients who take short-acting benzodiazepines (only temazepam or zolpidem are allowed) for sleep may continue to do so if they have been on a stable dose for 30 days prior to Screening;
    • Clonazepam may be used for treatment of restless legs syndrome, dystonia, or painful rigidity associated with PSP, if the dose has been stable for 30 days prior to Screening and is not expected to change during the study;
    • Quetiapine or clozapine may be permitted if at a stable dose for at least 30 days prior to Screening.
  • Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, Diagnostic Criteria for Drug and Alcohol Abuse.
  • Treatment with any investigational drug (including placebo) or device within 30 days prior to Screening.
  • Any vaccination within 30 days prior to study drug administration.
  • History of a clinically significant medical condition that would interfere with the patient’s ability to comply with study instructions, would place the patient at increased risk, or might confound the interpretation of the study results.
  • Known history of human immunodeficiency virus.
  • Physical and laboratory test findings, including the following:
    • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population;
    • Clinically significant abnormality on 12-lead ECG prior to study drug administration, confirmed by repeat testing;
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN), confirmed by repeat testing;
    • Total bilirubin > 1.2 × ULN (unless due to Gilbert’s syndrome);
    • Serum creatinine > 168 μmol/L (1.9 mg/dL), confirmed by repeat testing;
    • Hematocrit < 35% for males and < 32% for females or absolute neutrophil cell count of < 1500/μL;
    • Clinically significant abnormal thyroid stimulating hormone (TSH) test;
    • Abnormally increased number of white blood cells (> 7 cells/mm3) in the CSF obtained at the Screening Visit; if there is evidence that the spinal tap was traumatic, patients with > 7 cells/mm^3 must be discussed with the medical monitor to determine if they may be eligible;
    • Hemoglobin A1C > 7%, confirmed by repeat testing;
    • Positive blood screen for human immunodeficiency virus (HIV), hepatitis C antibody, or hepatitis B surface antigen.
  • Allergy to any of the components of TPN-101.
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
Drug
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Assessment of CXCL10 in Plasma-derived Small Extracellular Vesicles in Children with New Onset Diabetes (CXCL10)

Assessment of CXCL10 in Plasma-derived Small Extracellular Vesicles in Children with New Onset Diabetes

Ana Creo
All
1 years to 18 years old
This study is NOT accepting healthy volunteers
2021-305620-H01-RST
21-008585
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Inclusion Criteria:

  • Clinical diagnosis of diabetes based upon an elevated hemoglobin A1C.


Exclusion Criteria:

  • Diagnosis of Diabetic Nephropathy.
  • Active or unresolved Diabetic Ketoacidosis (DKA).
  • Steroid Induced Hyperglycemia.

Eligibility last updated 8/18/21. Questions regarding updates should be directed to the study team contact.

 

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Mayo Clinic — Rochester, MN

Autotransfusion During Intralesional Tumor Resection: Effectiveness of Leukocyte Reduction Filtration in Removing Neoplastic Cells (CSDTR)

Cell Saver During Tumor Resection

Matthew Houdek
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307110-H01-RST
22-000975
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Inclusion Criteria:

  • Any patient undergoing surgery for intralesional resection of neoplasm such as tumors of the spine/extremities or metastatic disease.


Exclusion Criteria:

  • Patients undergoing surgery with an expected blood loss of less than 135cc.
  • Provisions for inclusion of minorities: 
    • Subjects will be enrolled prospectively irrespective of their sex/gender, race, and ethnicity in order to improve generalizability.        

Eligibility last updated 2/21/22. Questions regarding updates should be directed to the study team contact.

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Physiological Changes in Response to Laboratory or Environmental Interventions and/or Stressors

A Study of Body Changes When Placed in High Challenge Stress

Bruce Johnson
All
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-116078-H01-RST
13-008101
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Inclusion Criteria

  • up to 200 subjects for the study
  • specific data sets of 15-20 individuals within a given type of activity or event
  • both males and females
  • between the ages of 18-80 years
  • individuals who have chosen to participate in a particular expedition, athletic event, clinical research study, or live in an extreme environment, independent of the present study
  • Subjects will have complete control over their willingness to participate in the study and control over whether or not to continue with the event or exposure regardless of the impact on the study
  • Written consent will be obtained from all subjects prior to participation

Exclusion Criteria

  • based on the requirements and exclusion criteria of the exposure the individual is receiving
  • will also include pregnancy
Other
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Detection of Diastolic Dysfunction Using Artificial Intelligence Applied to a Single Handheld Ultrasound Image

Diastolic Dysfunction Using Artificial Intelligence Applied to a Single Handheld Ultrasound Image

Patricia Pellikka
All
18 years and over
This study is NOT accepting healthy volunteers
2022-307715-H01-RST
22-003324
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Inclusion Criteria:

  • Adult male and female, age from 18 years old.
  • Having signs and symptoms of HFpEF. HFpEF (EF ≥ 40%, PCWP at rest ≥15 mm Hg).
  • With 1, 2, 3 grades or indeterminate degree of DD (ACC/AHA stages C and D HF).


Exclusion Criteria:

  • Reduced Ejection Fraction (EF ≤ 39%), mitral valve prosthesis, mitral stenosis.

Eligibility last updated 9/16/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock

All
18 Years and over
This study is NOT accepting healthy volunteers
NCT05426083
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Inclusion Criteria:

• Age 18-75 years
• SCAI D/E CS requiring VA-ECMO support based on treating team's judgement.
• MAP >65 mmHg on <3 vasopressors/inotropes at the time of consent
• Cardiogenic shock due to acute coronary syndrome identified by coronary angiography at the index hospitalization per standard cardiology practice
Exclusion Criteria:

• VA-ECMO for sepsis, pulmonary embolism, COVID-19 related cardiorespiratory failure, severe RV failure due to severe idiopathic pulmonary hypertension
• CS due to other (non-ACS) etiologies
• Known patient with severe left ventricular dysfunction and stage IV NYHA heart failure being evaluated for or with a history of LVAD and transplantation prior to commencement of VA-ECMO
• Profound vasoplegia with MAP <65 mmHg on 3 vasopressors/inotropes
• Moderate to severe aortic regurgitation (contraindication to VA-ECMO)
• Moderate to severe aortic stenosis (contraindication to LV instrumentation with PV loop catheter)
• Bleeding complications requiring ongoing transfusions of blood products
• Ischemic lower extremities
• Evidence of circuit thrombosis or fibrin accumulation (turndown increases risk for stroke and clot formation)
• Evidence of sepsis or septic shock
• Evidence of LV thrombus on echocardiography (contraindication for accessing LV cavity with catheters)
Other: Physiological Assessment
Acute Coronary Syndrome, Cardiogenic Shock
Acute Coronary Syndrome, Cardiogenic Shock, Left ventricle, VA-ECMO
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University of Minnesota — Minneapolis, Minnesota Julie Longman - (longm021@umn.edu)

Neighborhood Park Youth Sports Program Fee Waiver and Intensive Family Outreach (PARKS)

All
6 Years to 12 Years old
Phase 3
This study is also accepting healthy volunteers
NCT05231837
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Inclusion Criteria:

• age 6-12 years
• do not meet guidelines for recommended level of physical activity
• live in neighborhood served by one of 24 study parks
• able to be physically active
• do not plan to move in the next two years
Exclusion Criteria:

• younger than 6 or older than 12 years of age
• do not live within 2 miles of study park
• already meet physical activity guidelines
• not able to be physically active plan to move within two years
Behavioral: Experimental: Fee Waiver, Behavioral: Fee Waiver Plus Intensive Outreach
Physical Activity
Physical Activity Low Income Youth Parks
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University of Minnesota Division of Epidemiology & Community Health — Minneapolis, Minnesota

The Effect of Semaglutide in Subjects with Non-cirrhotic, Non-alcoholic Steatohepatitis (Essence)

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) (ESSENCE)

Alina Allen
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-304521-P01-RST
20-013372
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Inclusion Criteria:


- Age above or equal to 18 years at the time of signing informed consent.

- Histological evidence of NASH based on a central pathologist evaluation of the
baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained
within 180 days prior to the screening visit (V1).

- Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN
(Clinical Research Network) classification based on a central pathologist evaluation
of the baseline liver biopsy.

- A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal
to 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte
ballooning based on a central pathologist evaluation of the baseline liver biopsy.


Exclusion Criteria:


- Documented causes of chronic liver disease other than non-alcoholic fatty liver
disease (NAFLD)

- Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known
presence of HCV RNA or HBsAg within 2 years of screening (V2A).

- Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous
bacterial peritonitis or liver transplantation at randomisation.

- Known or suspected excessive consumption of alcohol (greater than 20 g/day for women
or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use
Disorders Identification Test (AUDIT questionnaire)).

- Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or
pioglitazone or medications approved for treatment of NASH which has not been at a
stable dose in the period from 90 days prior to the screening visit (V2A). In
addition, for subjects with historical liver biopsies taken more than 90 days prior to
screening, treatment should be at a stable dose in from time of biopsy until
screening.

- Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit
(V2A). In addition, for subjects with historical liver biopsies taken more than 90
days prior to screening, any treatment with GLP-1 RAs from time of biopsy until
screening (V2A).

- Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering
medication or weight loss medication not stable in the opinion of the investigator in
the period from 90 days prior to the screening visit (V2A). In addition, for subjects
with historical liver biopsies taken more than 90 days prior to screening, treatment
should be at a stable dose in the opinion of the investigator from time of biopsy
until screening.

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

Eligibility last updated 6/15/23. Questions regarding updates should be directed to the study team contact.

Behavioral, Drug
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Hydraderm for Androgenic Alopecia

All
18 Years to 65 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT05426629
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Inclusion Criteria:

• Participants who can give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA Authorization
• Participants who have androgenetic alopecia
• Healthy men and women, ages 18
•65 years of age
• Participants who understand the study and can follow study instructions and are willing to attend the required study visits
• Participants who agree to be photographed for research purposes and their identity may not be concealed in these photographs.
• Participants who agree to continue their same treatment they are on at the baseline visit for androgenetic alopecia, for the entire duration of the study without plans to stop, change or add additional treatments.
• Participants who agree to use the same shampoo for the duration of the study
Exclusion Criteria:

• Participants who have not had a change to hair loss treatment for 4 months prior to study enrollment
• Participants who have an active or known skin inflammation or infection within the treatment area.
• Participants who have an active or known acute skin allergies
• Participants who have any other scalp conditions including eczema, psoriasis, infection, or scars within the treatment area
• Participants of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy, or bilateral oophorectomy.
• Participants who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.
• Immunosuppression
• Participants who are HIV+ / Hepatitis B + / Hepatitis C+
• Participants who have been diagnosed or have a known history of any hematopathology disorders
• Participants who have been diagnosed or have a known history of haemostasis disorders
• Participants who have been diagnosed or have a known history of an autoimmune diseases
• Participants who are undergoing chemotherapy
• Participants with a history of any skin cancer on the scalp
• Participants who have had skin biopsy or procedure on scalp in last month
• Participants who have an implantable devices such as a deep brain stimulator in or other implantable device on or near treatment area
• Non-English speakers
Device: Venus Glow
Androgenic Alopecia
alopecia, hair loss, pattern hair loss, hydradermabrasion, female pattern hair loss, male pattern hair loss, dermatology
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University of Minnesota — Minneapolis, Minnesota Irmina Wallander - (dermresearch@umn.edu)

Dominantly Inherited Alzheimer Network - Therapeutic Treatment Unit (DIAN TU)

DIAN TU - Safety MRI Scan

Clifford Jack
All
18 years and over
This study is NOT accepting healthy volunteers
0000-115445-P01-RST
13-001249
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Subjects must be enrolled in DIAN Study at another site. Only safety MRI Scans are being performed at Mayo.

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Genomic and Environmental Basis of Imperforate Anus (IA)

Genomic and Environmental Basis of Imperforate Anus

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

  • Diagnosis of imperforate anus.


Exclusion Criteria:
 

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

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

 

Congenital disorder
Anal atresia, Genetic testing, Skin biopsy
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