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538 Study Matches

Osteosarcoma Maintenance Therapy With OST31-164 (OST-164-01)

This phase II trial studies OST31-164 as a single agent every 3 weeks for 48 weeks, with 4 doses constituting 1 treatment cycle (12 weeks per cycle). Each patient will receive treatment at a dose of 1x109 CFU until Week 48 or until disease progression, unacceptable toxicity, or the patient meets any other treatment discontinuation criteria. Following treatment discontinuation, all patients will enter a 3-year survival follow-up period. The primary endpoints are disease control during the first 12 months after enrollment and safety assessments (adverse events [AEs], physical examinations, clinical laboratory tests, vital sign measurements, performance status, and tests to monitor for the persistence of Lm).

Emily Greengard
All
12 Years to 39 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04974008
STUDY00013667
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Inclusion Criteria:

• Note: Patients enrolled on AOST2031 are eligible for enrollment in the present study. Patients are eligible to be included in the study only if all the following criteria apply: Age and Weight
• Between 12 years of age and 39 years of age at the time the Informed Consent/ Assent form is signed.
• Weight at least 40 kg. Diagnosis
• Has histologic confirmation of osteosarcoma at diagnosis.
• Has at least one episode of disease recurrence in the lungs without limitation on the number of episodes of recurrence as long as the following criteria are met:
• Surgical resection of all possible sites of suspected pulmonary metastases to achieve a complete remission within 8 weeks prior to study enrollment
• Pathological confirmation of osteosarcoma from at least one resected tumor.
• Patients will not require radiographic confirmation of complete remission for enrollment. However, a postoperative CT chest scan is required as a baseline for future comparisons. https://members.childrensoncologygroup.org/files/Disc/surgery/handbooks/OsteoBoneHandb ook.pdf) Performance Status
• Patient must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky scale for patients > 16 years of age and Lansky scale for patients < years of age Prior Therapy
• Patient must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, radiotherapy, or surgery prior to entering this study. Organ Function Requirements
• Patient has adequate organ function as defined below: a. Hematological: i. Absolute neutrophil count (ANC) is at least 1,000/µL without transfusion or growth factor support. ii. Platelet count ≥ 50,000/µL without transfusion or growth factor support. b. Adequate renal function defined as: i. Creatine clearance or radioisotope glomerular filtration rate (GFR) > 70 mL/min/1.73 m2 or ii. A serum creatine based on age/gender as follows: Maximum Serum Creatinine (mg/dL) Age: 12 to < 13 years Male :1.2 Female:1.2 Age:13 to < 16 years Male :1.5 Female:1.4 Age: ≥ 16 years Male :1.7 Female:1.4 Note: the threshold for creatinine values in this table were derived from the Schwartz formula for estimating GFR. c. Adequate liver function defined as: i. Total bilirubin < 1.5 x upper limit of normal (ULN) for age ii. Serum glutamic-pyruvic transaminase (SGPT) / alanine aminotransferase (ALT) < 110 U/L (for the purpose of this study the ULN for SGPT is 45 U/L) iii. Serum albumin > 2 g/dL d. Adequate coagulation i. International normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants. ii. Activated partial thromboplastin time (aPTT) < 1.5 x ULN unless patient is receiving anticoagulant therapy as long as aPTT is within therapeutic range of intended use of anticoagulants. e. Adequate cardiac function defined as: i. Shortening fraction of > 27% by echocardiogram, or ii. Ejection fraction of > 50% by radionuclide angiogram or echocardiogram f. Adequate pulmonary function defined as: i. No evidence of dyspnea at rest, no history of exercise intolerance, and a pulse oximetry of > 94%. g. Central nervous system (CNS) function defined as: i. Patients with a known seizure disorder may be enrolled if on anticonvulsants and/or are well-controlled. ii. CNS toxicity including peripheral neuropathy < Grade 2.
• Patient and/or patient's parent or legal guardian must be capable of understanding the investigational nature, potential risks, and benefits of the study. The patient and/or the parent or legal guardian must sign a written informed consent. Age-appropriate assent will be obtained per institutional guidelines. Contraception: Female patients :
• A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) as defined in the protocol OR
• A WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 120 days after the last dose of study treatment.
• A female patient of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving any dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Male patients:
• A male patient is eligible to participate if he agrees to follow the contraceptive guidance in the protocol during the study treatment period and for at least 120 days after the last dose of study treatment.
Exclusion Criteria:

• Has clinically evident metastatic or recurrent disease.
• Has concurrent pulmonary recurrence and local recurrence at the primary tumor site.
• Has primary refractory disease with progression of the primary tumor on initial-therapy.
• Has CNS or any extrapulmonary disease involvement at the time of the most recent episode of disease recurrence proceeding enrollment.
• Has active infection requiring systemic therapy or is dependent on or is currently receiving systemic antibiotics that cannot be discontinued before dosing. (Note: Patients who discontinue an antibiotic prior to dosing must wait at least 5 half-lives after the last dose of antibiotic before receiving any OST31-164 infusion). Inhaled prophylactic PJP (pneumocystis jiroveci pneumonia) treatment is acceptable per Investigator discretion.
• Is currently dependent on or has received corticosteroids within the past 4 weeks (topical corticosteroids and occasional inhaled corticosteroids are allowed).
• Is currently participating in or has participated in a study of an investigational agent or is using an investigational device within 4 weeks of the first dose of treatment.
• Has a history of other active malignancy for < 2 years prior to enrollment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy or is felt by the Investigator to be at low risk for recurrence is allowed.
• Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment.
• Has a known allergy to any component of the study treatment(s) formulations.
• Has a contraindication (e.g., sensitivity/allergy) to both trimethoprim/ sulfamethoxazole and amoxicillin.
• Has contraindication to administration of NSAIDs.
• Is currently receiving or will be receiving any chemotherapy, including PI3K inhibitors, during the treatment phase.
• Has had a prior monoclonal antibody therapy within 2 weeks prior to study Day 1.
• Requires or anticipates requiring tumor necrosis factor (TNF) blocking agent (e.g., infliximab) therapy for diagnosis of rheumatologic disease or inflammatory bowel disease (e.g., ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, or ulcerative colitis).
• Has previous history of listeriosis.
• Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
• Has known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected).
• Has received a live vaccine within 30 days prior to Study Day 1.
• Patient is or has an immediate family member (spouse, children, or parent) who is directly involved with this study or is employed by the investigational site or Sponsor, unless prospective Institutional Review Board (IRB) approval (by chair or designee) is given allowing exception to this criterion for a specific patient. Regulatory Requirements:
• All patients and/or their parents or legal guardians must sign a written informed consent.
• All institutional, FDA, and NCI requirements for human studies must be met.
Drug: OST31-164
Bone Cancer
Osteosarcoma, Bone Cancer
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Prospective tReatment EffiCacy in IPF uSIng genOtype for Nac Selection (PRECISIONS) trial (PRECISIONS)

Patients with idiopathic pulmonary fibrosis (IPF) that have the TOLLIP rs3750920 TT genotype will be treated with N-acetyl cysteine (NAC) compared to placebo, while receiving standard care. Standard of care is defined as allowing background therapy with FDA-approved medications for IPF, such as pirfenidone or nintedanib, if taking a stable dose for at least 6 weeks prior to enrollment.

Hyun Kim
All
40 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04300920
STUDY00012926
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Inclusion Criteria:

• ≥ 40 years of age
• Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator
• Signed informed consent
• If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit
• Confirmed rs3570920 TT TOLLIP genotype
Exclusion Criteria:

• Pregnancy or planning to become pregnant
• Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year during study participation
• Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure
• Receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer
• Supplemental or prescribed NAC therapy within 60 days of enrollment
• Listed for lung transplantation at the time of screening
• History of lung cancer
• Inability to perform spirometry
• Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1
• Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1
Drug: N-acetyl cysteine, Drug: Placebo
Idiopathic Pulmonary Fibrosis
IPF, Pulmonary Fibrosis, n-acetylcysteine, NAC, Clinics and Surgery Center (CSC)
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DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Compare overall survival for subjects treated with docetaxel versus subjects treated with docetaxel plus radium-223.

Gautam Jha
Male
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03574571
STUDY00011960
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Inclusion Criteria:

• Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
• Males 18 years of age and above
• Histological or cytological proof of prostate cancer
• Documented progressive mCRPC based on at least one of the following criteria:
• PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL.
• Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
• Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan.
• Two or more bone lesions
• ECOG 0- 1
• Normal organ function with acceptable initial laboratory values within 14 days of randomization:
• Albumin > 30 g/L
• ANC ≥ 1.5 x 10^9/L
• Hemoglobin ≥ 10 g/dL
• Platelet count ≥ 100 x 10^9/L
• Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
• Bilirubin ≤ ULN (unless documented Gilbert's disease)
• SGOT (AST) ≤ 1.5 x ULN
• SGPT (ALT) ≤ 1.5 x ULN
• WBC count ≥ 3 x 10^9/L
• Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
• Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
• All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less.
• Willing and able to comply with the protocol, including follow-up visits and examinations
Exclusion Criteria:

• Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization.
• Received external beam radiotherapy within the 4 weeks prior to randomization.
• Has an immediate need for external beam radiotherapy.
• Has received any systemic bone-seeking radiopharmaceutical in the past.
• Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.
• Has received four or more systemic anticancer regimens for mCRPC.
• Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC
• A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines.
• Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation.
• Has received blood transfusions or growth factors within the last 4 weeks prior to randomization.
• Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).
• Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization.
• Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms.
• Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
• Has imminent or established cord compression based on clinical findings and/or MRI.
• Known bone marrow dysplasia
• Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans
• Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to:
• Uncontrolled infection
• NYHA III or IV heart failure
• Crohn's disease or those with ulcerative colitis who have not undergone a colectomy
• Known active infection with HIV, Hepatitis B or Hepatitis C
Drug: Docetaxel 75 mg/m2, Drug: Docetaxel 60 mg/m2, Drug: Radium-223
Prostate Cancer
Radium-223, Docetaxel, 18-150, C16-174, DORA Trial, Clinics and Surgery Center (CSC)
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Validating a Self-fitting Hearing Aid

All
18 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT05246904
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Inclusion Criteria:

• mild to moderate hearing loss ability to follow written directions,
Exclusion Criteria:

• inability to use software during first visit
Other: Fitting algorithm
Hearing and Vision Loss
hearing aids, self-fitting
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Study of Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant (Prevent)

All
1 Year and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT05305040
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Key
Inclusion Criteria:

• ≥1 year of age at the day of screening visit.
• No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
• Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment
• Meet one or more of the following criteria at the time of randomization:
• Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
• Haploidentical donor
• Matched or Mismatched unrelated donor
• Use of umbilical cord blood as stem cell source
• Ex vivo graft manipulation resulting in T cell depletion
• Received anti-thymocyte globulin or alemtuzumab (Campath-1H) Key
Exclusion Criteria:

• History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
• Evidence of active Grade >2 acute GVHD
• Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
• Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day) within 24 hours prior to dosing
• Relapse of primary malignancy other than minimal residual disease Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Biological: Posoleucel (ALVR105), Biological: Placebo
Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections, Human Herpes Virus-6 Infection, JC Virus Infection
Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel, Viralym-M
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Impact of Sugars on Tobacco Product Toxicity and Abuse Liability

The purpose of this study is to better understand how varying levels of common sugars found in cigarettes affect how you smoke the cigarette and your responses to them.

Irina Stepanov
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT05308316
STUDY00011825
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Inclusion Criteria:

• Male or female age 21 years or older
• Smoking cigarettes that have been evaluated to have medium levels of sugar content
• No quit attempts in the past month nor intentions to quit smoking in the next month
• Participants are in good physical health (no unstable medical conditions) as determined by the licensed medical professional
• Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis) as determined by the licensed medical professional
• Stable vitals sign measurements (systolic BP ≤ 160 and >90 mmHg, diastolic BP ≤ 100 and >50 mmHg and heart rate ≤105 and > 45 bpm) as determined by the licensed medical professional
• Participants must be able to read for comprehension or completion of study documents (confirmed during informed consent process)
• Participants have provided written informed consent to participate in the study.
Exclusion Criteria:

• Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
• Women who are pregnant or nursing or planning to become pregnant.
Other: Sucrose cigarettes
Tobacco Use, Community Health, Prevention & Wellness
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Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE (EMERALD)

The aim of this study is to investigate how safe, effective, and well-tolerated multiple infusions of the experimental study treatment, Emapalumab, are in controlling macrophage activation syndrome (MAS), as well as to check the concentrations of Emapalumab in the blood and the speed at which it leaves the body. Participants will have been treated with previous treatment for MAS and are presenting an unsatisfactory response to that treatment. The previous drugs should include at least the corticosteroids. Your study doctor will taper corticosteroid progressively when emapalumab treatment would be started.

Bryce Binstadt
All
6 Months to 80 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05001737
STUDY00013755
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Inclusion criteria Run-in phase in all cohorts
• Informed consent provided by the subject or by the subject s' legally authorized representative(s) with the assent of subjects who are legally capable of providing it, as required by local law.
• Male and female subjects aged between 6 months and 80 years of age at the time of diagnosis of MAS.
• MAS defined as per the criteria defined below for each cohort and requiring treatment with GCs. Interventional phase in all cohorts
• Informed consent provided by the subject or by the subject's legally authorized representative(s) with the assent of subjects who are legally capable of providing it, as as required by local law.
• Male and female subjects aged between 6 months and 80 years of age at the time of diagnosis of active MAS.
• Subjects who have shown an inadequate response to high dose intravenous (i.v.) GCs administered for at least 3 days according to local standard clinical practice, including but not limited to pulses of 30 mg/kg PDN on 3 consecutive days. High i.v. GCs dose is recommended not to be lower than 2 mg/kg/ day PDN equivalent (or at least 60 mg/day in pediatric subjects of 30 kg or more, and at least 1g/day in adult MAS subjects). In case of rapid worsening of the subject's condition and/or laboratory parameters, as per Investigator judgment, inclusion may occur within less than 3 days from starting high dose GCs.
• Diagnosis of active MAS confirmed by the treating rheumatologist, having ascertained the followings: a. Febrile subjects presenting with ferritin > 684 ng/mL. b. and any 2 of: i. Platelet count ≤ 181 x109/L ii. AST-level > 48 U/L iii. Triglycerides > 156 mg/dL iv. Fibrinogen level ≤ 360 mg/dL
• Female subjects of child-bearing potential willing to use highly effective methods of contraception from study drug initiation to 6 months after the last dose of study drug. Specific inclusion criteria to Cohort 1 and Cohort 2
• Cohort 1:
• Confirmed sJIA diagnosis. For subjects presenting with MAS in the context of the onset of sJIA, high presumption of sJIA will suffice for eligibility.
• Confirmed diagnosis of AOSD as per Yamaguchi criteria.
• Cohort 2:
• Confirmed diagnosis of SLE as per SLICC'12 criteria. Exclusion criteria
• Primary HLH documented by either the presence of a known causative genetic mutation or abnormal perforin expression and CD107a degranulation assay as described with primary hemophagocytic lymphohistiocytosis or by the presence of family history.
• Confirmed malignancy. Note: subjects with a suspected malignancy should have mononuclear cells typed by flow cytometry and/or tissue biopsy, as applicable, to rule out malignancy.
• Treatment with canakinumab, JAK inhibitors, TNF inhibitors and tocilizumab at the time of emapalumab initiation.
• Ongoing treatment with anakinra at a dose above 4 mg/kg at time of emapalumab initiation.
• Subjects treated with etoposide for MAS in the last 1 month.
• Clinically active mycobacteria (typical and atypical), Histoplasma Capsulatum, or Salmonella infections.
• Evidence of leishmania infections.
• Evidence of latent tuberculosis.
• History of hypersensitivity or allergy to any component of the study drug.
• Receipt of a Bacillus Calmette-Guerin (BCG) vaccine within 12 weeks prior to screening.
• Receipt of a live or attenuated live (other than BCG) vaccine within 4 weeks prior to screening.
• Pregnancy or lactating female subjects.
Drug: Emapalumab
Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, Systemic Lupus Erythematosus, SJIA, AOSD, MAS
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MT2019-47 Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) Protocol Number: 208467

This is a master protocol to investigate the safety and antitumor activity of T-cell receptor (TCR) engineered NY-ESO-1 Specific (c259) T Cells alone or in combination with other agents in HLA-A*02+ participants with NY-ESO-1 and/or LAGE-1a positive solid tumors. The protocol will initially include a substudy to investigate letestregene autoleucel (lete-cel, GSK3377794) treatment in previously untreated (1L) HLA-A*02+ participants with NYESO-1+ advanced (metastatic or unresectable synovial sarcoma or myxoid/round cell liposarcoma (Substudy 1). A separate substudy will investigate letestregene autoleucel (lete-cel, GSK3377794) infusion as second line or higher (2L+) treatment in HLA-A*02+ participants with NY-ESO-1+ advanced metastatic or unresectable synovial sarcoma or myxoid/round cell liposarcoma, who have progressed following treatment with anthracycline based chemotherapy for the purpose of registration (Substudy 2). The protocol may be amended at a later time to add additional substudies to investigate other NY-ESO-1 or LAGE-1a positive tumor types and other NY-ESO-1-Specific (c259) T Cells (potentially in combination with other agents).

Emily Greengard
Phase II
This study is NOT accepting healthy volunteers
NCT03967223
STUDY00009020
Neoplasms
Adoptive T-cell therapy, Advanced metastatic disease, Advanced unresectable disease, Clinics and Surgery Center (CSC), GSK3377794, Lete-cel, Letetresgene autoleucel, Leukapheresis, Myxoid/round cell liposarcoma, Positive solid tumors, Synovial sarcoma, T-cell receptors
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A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors.

It is estimated the 20-40% of all patients with cancer develop brain metastases (Aoyama, Shirato et al. 2006). In fact, it is estimated that 200,000 new cases of brain metastases are diagnosed each year (Arvold, Lee et al. 2016). The size of the metastatic lesion often drives the treatment approach taken. Larger (>2cm) symptomatic lesions that are in an accessible location are typically resected, while smaller, deeper, asymptomatic lesions are usually treated using stereotactic radiotherapy (SRT) (Ewend, Morris et al. 2008). With resection alone, and no adjunctive radiation treatment, it has been demonstrated that surgical bed (SB) control (no tumor regrowth in the SB of the resected tumor) at 12 months is approximately 37-45% of patients (Patchell, Tibbs et al. 1990, Kocher, Soffietti et al. 2011, Mahajan, Ahmed et al. 2017). Whole brain radiation treatment (WBRT) after surgical resection has been used in the past and achieved SB control in 76-88% of patients at 12 months (Patchell, Tibbs et al. 1990, Kocher, Soffietti et al. 2011, Brown, Ballman et al. 2017): however, this high rate of SB control was at the expense of cognitive decline due to the impact of radiation on normal brain tissue (Brown, Ballman et al. 2017). Stereotactic radiotherapy (SRT) improves local control over resection alone, with a rate of approximately 61-72% at 12 months (Brown, Ballman et al. 2017, Mahajan, Ahmed et al. 2017), and has become the preferred standard of care over WBRT (NCCN Guidelines 2019). In patients who receive fractionated stereotactic radiation therapy (FSRT) treatment in the postoperative setting, radiation necrosis rates can be significant. Recently, Tanenbaum et al, reported that a fairly commonly used postoperative 5-fraction FSRT regimen resulted in radiation necrosis with an incidence rate of 18.2% (Tanenbaum, Buchwald et al. 2020). Thus, there is an unmet need for an adjunctive radiation therapy approach that may improve the rate of surgical bed control equal to or greater than WBRT, but without the inherent risks of radiation brain injury to normal tissue.

Clark Chen
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04365374
STUDY00012456
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Inclusion Criteria:

• Patients aged 18 years old and above. Eligibility is restricted to this age group given that the battery of neurocognitive tests utilized in this protocol are not developed or validated for use in a younger population.
• One to four newly diagnosed brain metastases, identified on the screening MRI, from an extracranial primary tumor.
• One lesion, designated the index lesion, is planned for surgical resection and is to be between 2.5 cm and 5.0 cm on the screening MRI. Index lesions > 2.0 cm but <2.5 cm are also eligible if surgery is deemed clinically necessary and appropriate for an attempted gross total resection by the neurosurgeon.
• Non-index lesions must measure < 4.0 cm in maximal extent on the screening MRI brain scan. The unresected lesions will be treated with SRT as outlined in the treatment section of the concept.
• All metastases must be located > 5 mm from the optic chiasm and outside the brainstem. Dural based metastasis are eligible.
• Previous and/or concurrent treatment with systemic therapies (e.g., chemotherapy, targeted therapeutics, immunotherapy) is permitted and must follow protocol guidelines as follows: Systemic therapy is allowed a minimum of one week from last systemic therapy cycle to surgical resection, and one week after surgical resection to allow a minimum of one week before starting/resuming systemic therapy, depending on the specific systemic agent(s), as recommended by medical/neuro-oncology. Systemic therapy is not allowed 1 day before SRT, the same day as the SRT, or 1 day after the completion of the SRT or longer, depending on the specific systemic agent(s), as recommended by medical/neuro-oncology. Agents that are delivered by implant or depot injections (such as hormonal therapies) are excluded from these restrictions.
• KPS score of ≥70.
• Stable systemic disease or reasonable systemic treatment options predicting a life expectancy of ≥6 months.
• Ability to complete an MRI of the head with contrast
• Adequate renal and hepatic function to undergo surgery, in investigators opinion.
• For women of childbearing potential only, a negative urine or serum pregnancy test done < 7 days prior to randomization is required. Women must be willing to notify investigator immediately if they become pregnant at any time during the trial period.
• Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.
• Subjects must be fluent in English language to allow for completion of neurocognitive tests and completion of QOL questionnaires. Non-English speaking subjects are not permitted to participate given that participation in the real time integrated neurocognitive function tests is mandatory for all patients. The psychometric properties for translated tests are either not known or not as robust.
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures. Exclusion Criteria
• Age <18 years.
• KPS<70
• Past radiation or surgical therapy to the index lesion or the newly diagnosed non-index lesion(s) is exclusionary. However, up to a total of 2 prior courses of SRT treatment to previously diagnosed lesions are allowed as long as any treated lesions are were >15mm from the index lesion.
• Patients with >4 newly diagnosed metastases on screening MRI
• Pregnant patients.
• Primary germ cell tumor, small cell carcinoma, or lymphoma.
• Leptomeningeal metastasis (LMD). Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as radiologic or clinical evidence of leptomeningeal involvement with or without positive cerebrospinal fluid (CSF) cytology.
• Prior WBRT for brain metastases.
• Concomitant therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
• Comorbid psychiatric or neurologic disease or injury impacting cognition, in the opinion of the treating physician, that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
• Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care.
Device: Gamma Tile-Surgically Targeted Radiation Therapy (STaRT), Radiation: Stereotactic Radiation Therapy
Brain Metastases
Brain, Tumor, Cancer, New Diagnosis, Metastases, GammaTile, Radiation, Cs-131, Clinics and Surgery Center (CSC)
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Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children (FSGS pediatric)

This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ≥ 60 ml/min/1.73m2, or the patient is post renal transplantation.

All
up to 21 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02235857
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Inclusion Criteria:

• A pediatric patient is deemed suitable for inclusion in the study if the patient has FSGS with a GFR ≥ 45 ml/min/1.73 m 2 and any of the following:
• Refractory nephrotic syndrome in which standard treatment options are unsuccessful (i.e., patient is unresponsive to standard corticosteroid and/or calcineurin inhibitor therapy for at least 8 weeks resulting in failure to achieve complete or partial remission);
• Refractory nephrotic syndrome in which standard treatment options are not well tolerated (i.e., patients intolerant to standard therapies due to severe side effects that negatively affect quality of life without providing an acceptable level of clinical benefit);
• Refractory or recurrent nephrotic syndrome in which standard therapy is contraindicated. or
• Pediatric post renal transplant patients with nephrotic syndrome associated with primary FSGS.
Exclusion Criteria:

• General Exclusion Criteria
• Patient is greater than 21 years of age
• Parent or patient is unwilling or unable to sign and date the informed consent (Note: Only patients 18-21 years of age may sign the informed consent on their own behalf)
• Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of Liposorber® in pregnant women has not been studied. There may be unknown risks to an embryo/fetus. Sexually active women of child bearing potential should avoid pregnancy during the use of the Liposorber device and throughout the study duration.)
• Unable or unwilling to comply with the follow-up schedule
• Simultaneously participating in another investigational drug or device study
• Body weight < 15 kg (33.1 lbs)
• Medical Exclusion Criteria
• Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.)
• Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., Angiotensin II receptor blockers (ARBs) that cannot be withheld on the day of apheresis until after the procedure
• Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis
• Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
• Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
• Extracorporeal circulation therapy with Liposorber® LA-15 System cannot be tolerated due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe uncontrollable hypotension
• Cardiac impairments such as uncontrolled arrhyth¬mia, unstable angina, decompensated congestive heart failure, or valvular disease
• Functional thyroid disease or liver abnormalities
• Unresolved systemic or local infection that could affect the clinical study outcomes
Device: LIPOSORBER® LA-15 System
Focal Segmental Glomerulosclerosis
pediatric, renal transplantation, recurrence, drug-resistant
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A Phase I Study of HCW9218, a Bifunctional TGF-B; Antagonist/IL-15 Protein Complex, in Select Advanced Solid Tumors After Failing at Least Two Prior Therapies

This is a single center, Phase I dose finding study of HCW9218 for the treatment of select advanced solid tumor cancers, including, but not limited to breast, ovarian, prostate and colorectal. HCW9218 potently activates natural killer (NK) cells and CD8+ T cells in vitro and in vivo to promote their proliferative and metabolic activities and enhance their cytotoxicity against tumor targets. The fusion complex also exhibits TGF-β neutralizing activity in vitro and sequesters plasma TGF-β in vivo. It is hypothesized that HCW9218 may serve as a novel therapeutic to simultaneously provide immunostimulation and lessen immunosuppression associated with solid tumors. The primary objective of this study is to determine the maximum tolerated dose (MTD) of HCW9218 as monotherapy in advanced solid tumor cancers except pancreatic cancer and primary brain tumors.

Melissa Geller, MD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05322408
STUDY00015102
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Inclusion Criteria:

• Histologically or cytologically confirmed advanced/metastatic solid tumor cancer (except pancreatic and primary brain cancers), has failed at least 2 prior lines of therapy given either in the recurrent or metastatic setting and must be refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
• Measurable disease per RECIST v 1.1.
• Acute effects of any prior therapy must have resolved to baseline or Grade ≤1 NCI CTCAE v5 except for AEs not constituting a safety risk by enrolling Investigator judgment.
• Age 18 years or older at the time of consent.
• ECOG Performance Status 0 or 1.
• Evidence of adequate organ function within 14 days prior to enrollment as defined in Section 4.1.6.
• Adequate pulmonary function with PFTs >50% FEV1 if symptomatic or known impairment.
• Sexually active persons of child-bearing potential or with partners of childbearing potential must agree to use a highly effective form of contraception (refer to Section
• 1.10 for acceptable methods) for at least 28 days after the last dose of HCW9218.
• Provides voluntary written consent prior to the performance of any research related activity.
Exclusion Criteria:

• Pregnant or breastfeeding.
• History of clinically significant vascular disease, including any of the following within 6 months prior to start of study treatment: MI or unstable angina, percutaneous coronary intervention, bypass grafting, ventricular arrhythmia requiring medication, stroke or transient ischemic attack, symptomatic peripheral arterial disease.
• Marked baseline prolongation of QT/QTc interval (e.g., demonstration of a QTc interval greater or equal to 470 milliseconds by Fridericia's correction).
• Known or suspected untreated CNS metastases.
• Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days before treatment start.
• Other prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the subject is currently in complete remission, or any other cancer from which the subject has been disease-free for 3 years after surgical treatment.
• Known hypersensitivity or history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study.
• Prior therapy with TGF-β antagonist, IL-15 or analogs.
• Concurrent use of St. John's wort and and/or other herbal CYP modulators within 7 days of Day 1. Must agree to not use during study treatment through the end of treatment visit to be eligible.
• Known autoimmune disease requiring active treatment. Persons with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
• Prior organ allograft or allogeneic transplantation.
• Known HIV-positive or AIDS.
• Psychiatric illness/social situations that would limit compliance with study requirements.
• Other illness or a medical issue that in the opinion of the Investigator would exclude the subject from participating in this study
Drug: HCW9218
Solid Tumor
Clinics and Surgery Center (CSC), Phase I Clinic
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Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas (POPLAR-NF2)

This study will investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutations. This study is a parallel-group, two-staged, Phase 2/3, randomized, multi-center study with two cohorts: Cohort A followed by Cohort B. The purpose of Cohort A is to provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas, and provide guidance for the correct dose, population, sample size, and endpoint for the confirmatory part of the study (Cohort B). Additional goals for Cohort A are to assess effects of food on drug absorption. The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas.

All
12 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT05130866
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Inclusion Criteria:

• ≥12 years of age and weighing at least 40 kg
• Progressive meningioma that is amenable to volumetric analysis
• Has either 1) sporadic meningioma with confirmed NF2 mutation; or, 2) confirmed diagnosis of NF2 disease (revised Manchester criteria); or, 3) at least one NF2-related tumor (with pathogenic germline or proven mosaic NF2 variant)
• Adequate bone marrow function
• Has provided written informed consent/assent to participate in the study
Exclusion Criteria:

• Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months.
• Received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 6 months prior to screening.
• Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening.
• History of an active malignancy within the previous 3 years except for localized cancers that are considered cured, and, in the opinion of the investigator, present a low risk of recurrence.
• Received another investigational drug within 30 days prior to screening
• Pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dose of IMP.
Drug: REC-2282, Drug: Placebo
Neurofibromatosis Type 2
Neurofibromatosis Type 2, Neurofibromatosis Type II
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Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients undergoing Sevoflurane Anesthesia

Study is to investigate the relationship between Bispectral Index (BIS) values including EEG profile and anesthetic agents in the pediatric population.

Benjamin Kloesel
up to 18 Years old
Pivotal
ANES-2021-30290
STUDY00014663
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Inclusion Criteria:
-Pediatric Subjects aged: 4 years to 18 years scheduled for procedures with sedation where the process of assessment will not interfere with the procedure, progress, or patient care
Exclusion Criteria:
-severe contact allergies -Known neurological disorder -Severe developmental delay -Airway abnormalities -Pregnancy -Taking psychoactive medications
• Taking any medications that may have an impact on the Central Nervous System
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A novel Peptamen-based enteral nutrition protocol for treatment of Crohn s disease A Pilot Trial

The purpose of this study is to evaluate the therapeutic feasibility of a Peptamen-based, oral nutrition dietary regimen for treatment of adult Crohn’s disease. Specifically we are evaluating if consuming 80-100% of caloric needs from Peptamen 1.5 for 4 weeks is feasible for the potential future use therapeutically in adult Crohn’s disease.

Byron Vaughn
18 Years and over
Pilot
This study is NOT accepting healthy volunteers
GI-2019-28202
STUDY00008169
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Inclusion Criteria:
? 18-89 years of age ? Diagnosis of Crohn's disease ? Moderate to severe Crohn's disease on current therapy
Exclusion Criteria:
? Diagnosis of short bowel syndrome ? Presence of ileostomy or colostomy ? Chronic Kidney Disease Stage III-V
Digestive & Liver Health, Microbiota
Crohn?s disease, IBD, dietary intervention, enteral nutrition, inflammatory bowel disease
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MT2021-33: Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, with Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

To compare the percent of participants who have clearance of AdV viremia at Day 29 in participants receiving posoleucel and standard of care to that in participants receiving placebo and standard of care.

Paul Orchard
Phase III
This study is NOT accepting healthy volunteers
NCT05179057
STUDY00014640
Adenovirus Infection
ALVR105, Adenoviremia, Adenovirus, Allogeneic Hematopoietic Cell Transplant, Clinics and Surgery Center (CSC), Posoleucel, Stem cell transplant
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Measurement of Upper Aerodigestive Tract Pressures During Phonation

The purpose of this pilot research study is to test whether a tool called “High-Resolution Manometry” can diagnose laryngeal dystonia (also known as spasmodic dysphonia) and measure how well treatment works. High-Resolution Manometry measures pressures from a small catheter that is passed from your nose into your throat. We believe that pressures in the throat might be different for people with laryngeal dystonia than for people without laryngeal dystonia, or with other types of voice disorders. If we can diagnose laryngeal dystonia shortly after symptoms start, we can get patients the treatment they need sooner.

Jesse Hoffmeister
18 Years and over
Pilot
This study is also accepting healthy volunteers
ENT-2022-30531
STUDY00015206
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Inclusion Criteria:
Patients with adductor laryngeal dystonia:
• Have experienced improvement in voice quality following injection of botulinum toxin into the thyroarytenoid complex
• Have received their most-recent injection within 6 months
• Age 18-80 years old
• Able to participate in informed consent
• Able to read and write in English Healthy Controls
• Age 18-80
• Have no known voice problem
• Have a VHI-10 score of 10 or below
• Able to participate in the informed consent process
• Able to read and write in English
Exclusion Criteria:
Patients with adductor laryngeal dystonia:
• Diagnosis of vocal tremor, abductor laryngeal dystonia, any type of vocal fold lesion, or vocal fold paralysis
• Known swallowing disorder (oropharyngeal or esophageal), with the exception of transient post-botulinum toxin injection-induced dysphagia
• Pregnant
• Prisoner
• Allergy to topical anesthetic
• Cannot fast for 6 hours (4 hour fast prior to study, up to 2 hours to complete the study)
• Recent facial trauma
• Recent nasal, pharyngeal, laryngeal, or esophageal surgery
• Known nasal, pharyngeal, or esophageal obstruction Healthy Controls
• VHI-10 Score of 11 or above
• Report having a current voice or swallowing disorder
• Pregnant
• Prisoner
• Allergy to topical anesthetic
• Cannot fast for 6 hours (4 hour fast prior to study, up to 2 hours to complete the study)
• Recent facial trauma
• Recent nasal, pharyngeal, laryngeal, or esophageal surgery
• Known nasal, pharyngeal, or esophageal obstruction
Ear, Nose & Throat
Clinics and Surgery Center (CSC)
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Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM)

The purpose of this research study is to find out how many people with acute pancreatitis develop diabetes. Risk factors for diabetes and the types of diabetes that occur after acute pancreatitis will also be studied. A small number of people who already had diabetes before their acute pancreatitis attack will be enrolled for comparison. Diabetes is a known complication of acute pancreatitis. Diabetes can last a few weeks after acute pancreatitis and get better. Diabetes may not improve after acute pancreatitis. It can also appear a year or more after acute pancreatitis. Little data is available on diabetes after acute pancreatitis. This study will help us better understand diabetes after acute pancreatitis and who is at increased risk of developing it, as well as the different types of diabetes. We are asking participants to take part in this research study who have recently had an acute pancreatitis attack. Participants may be on this study for up to 5 years. There is a screening/enrollment visit, a metabolic visit and 5 year follow-up period. If you had diabetes before your acute pancreatitis attack, your study participation will end after the enrollment visit. If you did not have diabetes before your acute pancreatitis attack, you will return to the clinic for up to 6 more visits. An additional two visits can be done either at the clinic or by phone. If you are diagnosed with diabetes during the follow-up period, you will be asked to come in for an additional visit.

Melena Bellin
NA
PEDS-2021-29897
STUDY00013389
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Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae (AVPAS)

This post-market approval study (PAS) is a prospective, multi-center, single-arm study intended to demonstrate safety and assess the clinical use and outcomes of the LUTONIX® Catheter in dysfunctional arteriovenous fistulae (AVF) in a heterogeneous patient population in real world clinical practice. The study will include approximately 213 subjects across 30 U.S. and international sites. The LUTONIX® Catheter was approved by FDA on August 25, 2017 (PMA P170003) for the indication of percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of stenotic lesions in dysfunctional arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length. The study involves no intervention and all medical procedures are standard of care and not research. Follow-up information will be obtained at 6, 12, 18, and 24 months after the index procedure, and vital status will be assessed at 36, 48, and 60 months.

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03506308
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Inclusion Criteria:

• Male or non-pregnant, non-breastfeeding female ≥18 years of age
• Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits
• Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines
• Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
• Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein
• Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:
• No clinically significant dissection;
• No extravasation requiring treatment;
• Residual stenosis ≤30% by angiographic measurement;
• Ability to completely efface the waist using the pre-dilation balloon.
Exclusion Criteria:

• Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study
• Subject has a non-controllable allergy to contrast
• Subject has another medical condition that, in the opinion of the Investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up
• Target lesion is located central to the axillosubclavian junction
• A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure
• Prior surgical interventions of the access site ≤30 days before the index procedure
• Target lesion is located within a bare metal or covered stent
Device: LUTONIX 035 Drug Coated Balloon PTA Catheter
Arteriovenous Fistula
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Autonomic and Vascular Mechanisms of Cardiovascular Risk in Women with Post-traumatic Stress-Disorder (PTSD)

Having PTSD is associated with a higher risk of developing Cardiovascular Disease (CVD), which presents a major health risk for women, who are twice as likely as men to develop PTSD. The purpose of this study is to learn more about the mechanisms behind the relationship between PTSD and increased cardiovascular risk. Ultimately, our goal is to use the knowledge gained from this research study to help develop intervention and treatment strategies to protect the cardiovascular health of women with PTSD.

Ida-Arlaine Fonkoue
18 Years and over
NA
This study is also accepting healthy volunteers
PMR-2021-30243
STUDY00014457
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Inclusion Criteria:
In addition to age and sex, other key inclusionary criteria are pre-menopausal and must have experienced a past trauma with or without PTSD Diagnosis.
Exclusion Criteria:
In addition to age and sex criteria, other exclusionary criteria are pregnant or breastfeeding; severe traumatic brain injury, hypertension, diabetes, heart disease, or vascular disease; illicit drugs within the past 6-months prior to participation; and inability or unwillingness to abstain from nicotine use for at least 12 hours prior to Study Visits 2 & 3.
Cardiovascular, Cardiovascular Disease (CVD), PTSD, Post-Traumatic Stress Disorder, female, women
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The use of hydradermabrasion in the scalp to improve scalp health and improve outcomes in androgenetic alopecia

This study aims to ovaluate the effect of hydradermabrasion for scalp health in patients with androgenetic alopecia, G1 to G4 according to Hamilton Norwood Classification with trichoscopic investigation.

Ronda Farah
18 Years and over
NA
This study is NOT accepting healthy volunteers
DERM-2021-30436
STUDY00014421
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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 Healthy men and women, ages 18 ? 45 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.
Exclusion Criteria:
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
Androgenetic Alopecia, Hair Loss, Hydradermabrasion, Male and Female Pattern Hair Loss, Scalp
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Evaluation of Point-of-Care (EPOC) for COVID-19 ((EPOC))

The overall objective of this protocol is to assess the feasibility of using POC antibody tests for patient management.

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05227404
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Inclusion Criteria:

• Age ≥ 18 years.
• Informed consent by the patient or the patient's legally authorized representative (LAR) for up to 4 fingersticks for POC testing and a blood draw for stored blood samples.
• SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to consent OR documented by NAT or equivalent testing more than 3 days prior to consent AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator. (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained for TICO and that list will also be used for this protocol.)
• Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator.
• Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.
Exclusion Criteria:

• Prior receipt of SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19, or SARS-CoV-2 nMAb within 6 months of the blood draws for testing as part of this protocol.
• Disease severity beyond that of stratum 1 in the TICO trial. This includes the following conditions:
• stroke
• meningitis
• encephalitis
• myelitis
• myocardial infarction
• myocarditis
• pericarditis
• symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] class III-IV)
• arterial or deep venous thrombosis or pulmonary embolism
• Current requirement for any of the following:
• high-flow supplemental oxygen
• non-invasive ventilation
• invasive mechanical ventilation
• extracorporeal membrane oxygenation
• mechanical circulatory support
• vasopressor therapy
• commencement of renal replacement therapy at this admission (i.e., not patients on chronic renal replacement therapy).
• In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments.
Diagnostic Test: LumiraDX, Diagnostic Test: RightSign, Diagnostic Test: Case Control
COVID-19, SARS CoV 2 Infection
COVID-19, SARS COV 2, COVID19 testing
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Assessment of the impact of transcatheter stenting of aortic coarctation on the left ventricular afterload and work using left ventricular pressure volume loops

The purpose of this study is to understand the effects of stent therapy of coarctation of the aorta on the left ventricular afterload and mechanics by obtaining intracardiac pressures and volume using a special P-V loop catheter system.

Gurumurthy Hiremath Mallikarjun
All
6 Years and over
NA
This study is NOT accepting healthy volunteers
NCT05362721
STUDY00005855
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Inclusion Criteria:

• Children 6 years of age and older and adults of all races and both sexes referred for elective cardiac catheterization and stent therapy for coarctation
• Those who provide informed consent for study participant.
Exclusion Criteria:

• Children who undergo other interventions in addition to the coarctation
• Children with single ventricle physiology.
• Renal impairment
• Participant unwilling to sign a consent form.
Diagnostic Test: Pressure-volume loop catheter
Coarctation of Aorta
Coarctation of Aorta, COA
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HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03734393
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Inclusion Criteria:

• Participant meets the standard criteria for liver transplant at the local center.
• Participants being listed for a simultaneous liver kidney (SLK) are eligible if participants meet the standard criteria for both organs.
• Participant is able to understand and provide informed consent.
• Participant meets with an independent advocate per the HIV Organ Policy Equity (HOPE) Act Safeguards and Research Criteria.
• Documented HIV infection (by any licensed assay or documented history of detectable HIV-1 RNA).*
• Participant is ≥ 18 years old.
• Opportunistic complications: prior history of certain opportunistic infections is not an exclusion if the participant has received appropriate therapy and has no evidence of active disease. Medical record documentation should be provided whenever possible.
• CD4+ T-cell count: ≥ 100/µL within 16 weeks prior to transplant if no history of AIDS-defining infection; or ≥ 200 μL if history of opportunistic infection is present.
• HIV-1 RNA is below 50 RNA/mL.* Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements > 200 copies/mL. *Organ recipients who are unable to tolerate anti-retroviral therapy (ART) due to organ. failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.
• Participant must have or be willing to start seeing a primary medical care provider with expertise in HIV management.
• Participant is willing to comply with all medications related to participant's transplant and HIV management.
• For participants with a history of aspergillus colonization or disease, no current clinical evidence of active disease.
• Agreement to use contraception.
• Participant is not suffering from significant wasting (e.g. body mass index < 21) thought to be related to HIV disease.
Exclusion Criteria:

• Participant has a history of progressive multifocal leukoencephalopathy (PML), or primary central nervous system (CNS) lymphoma.*
• Participant is pregnant or breastfeeding. (Note: Participants who become pregnant post-transplant will continue to be followed in the study and will be managed per local site practice. Women that become pregnant should not breastfeed.)
• Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Other: HIVD+/R+
Hiv
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in the Treatment of Subjects with Alopecia Areata

This research is studying a new treatment, rosnilimab, in a small number of people to learn about the safety, potential effect on alopecia areata, and how it interacts with the body. Researchers want to understand if rosnilimab may cause hair regrowth in people with alopecia areata and how it may work.

Maria Hordinsky
18 Years and over
Phase II
This study is NOT accepting healthy volunteers
NCT05205070
STUDY00014901
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Inclusion Criteria:
Men and women, adults 18- 65 years of age who are in good health Diagnosed with severe or very severe Alopecia Areata and have greater than or equal to 50% scalp hair loss Must be willing to stop using other types of medications to treat Alopecia Areata throughout the study Attend 10 visits over 28 weeks Other requirements, which the study team will review with you
Exclusion Criteria:
Subjects cannot participate in this study if they have another cause of hair loss in addition to alopecia areata. Subjects also cannot participate if they have had surgery in the last 4 weeks, if immune system is compromised, if are allergic to anything in rosnilimab, if recently used a prescription treatment for alopecia areata, if have tuberculosis, if person is pregnant or breastfeeding, or if person intends to become pregnant while part of this study. Subjects cannot participate in this study if they are currently part of another study that is using an experimental drug or device (medical tool).
Alopecia Areata, Dermatology (Skin, Hair & Nails), Immune Diseases
hair loss, Alopecia areata, PD-1 receptor, Rosnilimab
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IMPact on Revascularization Outcomes of intraVascular ultrasound guided treatment of complex lesions and Economic impact (IMPROVE)

To compare the outcomes of patients with complex lesions treated with imaging guidance with IVUS versus angiography only.

Ganesh Raveendran
Phase IV
This study is NOT accepting healthy volunteers
NCT04221815
STUDY00014771
Atherosclerosis
Clinics and Surgery Center (CSC)
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R01HL153613: Comprehensive Proteomic Classifier for the Molecular Characterization of Pulmonary Sarcoidosis

This study proposes to collect lung fluid to identify potential biomarkers associated with pulmonary sarcoidosis, and to compare those with healthy controls.

Maneesh Bhargava
18 Years and over
NA
This study is also accepting healthy volunteers
PACCS-2021-30089
STUDY00013734
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Inclusion Criteria:

• Age 18-80
• Those living with Sarcoidosis: Contact umnsarc@umn.edu for inclusion/exclusion criteria
Exclusion Criteria:

• History/Current use of cigarette, e-cigarette, vaping or marijuana smoking
• History/Current use of nicotine products
• Presence of underlying chronic condition
• Inability to undergo procedure using IV sedation
• Weight < 110 lbs. & BMI > 35 kg/m2
• Pregnant and/or breast feeding
• History/Current use of chronic immunosuppressive medications
• Those living with Sarcoidosis: Contact umnsarc@umn.edu for inclusion/exclusion criteria
Breathing, Lung & Sleep Health, Respiratory System
Sarcoid, Clinics and Surgery Center (CSC), Lung, Pulmonary, Sarcoidosis
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COG APAL2020SC - Pediatric Acute Leukemia (PedAL) Screening Trial Developing New Therapies for Relapsed Leukemias

This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults (0-<22 years old).

Emily Greengard
All
up to 22 Years old
NA
This study is NOT accepting healthy volunteers
NCT04726241
STUDY00015549
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Inclusion Criteria:

• Patients must be less than 22 years of age at the time of study enrollment
• Patient must have one of the following:
• Patient has known or suspected relapsed/refractory (including primary refractory) AML
• This includes isolated myeloid sarcoma
• Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome
• Patient has known or suspected relapsed ALL that meets one of the following criteria:
• Second or greater B-ALL medullary relapse, excluding KMT2Ar.
• Any first or greater B-ALL medullary relapse involving KMT2Ar.
• Any first or greater T-ALL medullary relapse with or without KMT2Ar.
• Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia
• Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment related AML
• 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
Procedure: Biospecimen Collection
Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent B Acute Lymphoblastic Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Recurrent T Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Mixed Phenotype Acute Leukemia, Therapy-Related Acute Myeloid Leukemia
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Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209)

All
18 Years to 99 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT05267106
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Inclusion Criteria:

• Histological, cytological, or molecular confirmation of recurrent GBM or other adult-type, diffuse glioma or circumscribed astrocytic tumors.
• For Cohorts A and C: Prior histopathologically proven WHO grade 4, IDH-wild-type GBM OR molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of WHO grade 4 GBM (astrocytic glioma requires presence of either amplification of EGFR, whole chromosome 7 gain and whole chromosome 10 loss, or TERT-promoter mutation; Louis et al 2021) that has recurred or progressed on or after treatment with at least 1 line of standard of care therapy (eg, temozolomide and radiotherapy or radiotherapy).
• For Cohorts B and C: Prior histopathologically proven, per WHO criteria, adult-type diffuse gliomas other than GBM, including IDH-mutant astrocytoma and IDH-mutant and 1p/19q codeleted oligodendroglioma, and circumscribed astrocytic tumors, including pilocytic astrocytomas, that are recurrent or progressed on or after at least 1 line of standard of care therapy (eg, radiotherapy and/or treatment with an alkylating chemotherapy such as TMZ, CCNU, or BCNU-containing chemotherapy). For Cohort C, all gliomas and glioneuronal and neuronal tumors with a known or likely FGFR 1-3 activating mutation are also eligible.
• Radiographically measurable disease. Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if progression has been clearly demonstrated in the lesion.
• Karnofsky performance status ≥ 60.
• Life expectancy ≥ 12 weeks.
• Documentation of an FGFR1-3 gene mutation or fusion/rearrangement from tissue (cfDNA from a qualified laboratory such as FMI or Guardant Health may be acceptable after review by medical monitor).
• Cohort A: Participants with prior, histopathologically proven, WHO grade 4,IDH-wild-type GBM OR molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of WHO grade 4 GBM (astrocytic glioma requires presence of either amplification of EGFR, whole chromosome 7 gain and whole chromosome 10 loss, or TERT-promoter mutation; Louis et al 2021) that has recurred, harboring FGFR1-3 fusions or rearrangements (FGFR1-3 in-frame fusions, any FGFR2 rearrangement, or FGFR1/3 rearrangement with known partner). Only FGFR fusions or rearrangements with an intact kinase domain are eligible.
• Cohort B: Participants with other histopathologically proven, per WHO criteria dult-type, diffuse gliomas other than GBM, including IDH-mutant astrocytoma and IDH-mutant and 1p/19q codeleted oligodendroglioma, and circumscribed astrocytic tumors, including pilocytic astrocytomas that are recurrent, harboring FGFR1-3 fusions or rearrangements (FGFR1-3 in-frame fusions, any FGFR2 rearrangement, or FGFR1/3 rearrangement with known partner). Only FGFR fusions or rearrangements with an intact kinase domain are eligible.
• Cohort C: Participants with prior, histopathologically proven, WHO grade 4, IDH-wild-type GBM or molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of WHO grade 4 GBM that has recurred or histopathologically proven, per WHO criteria, adult-type, diffuse gliomas other than GBM, including IDH-mutant astrocytoma and IDH-mutant and 1p/19q codeleted oligodendroglioma, and circumscribed astrocytic tumors, including pilocytic astrocytomas, that are recurrent with a known or likely activating mutation or FGFR1-3 mutation. All gliomas and glioneuronal and neuronal tumors with a known or likely FGFR 1-3 activating mutation are also eligible.
• MRI-documented objective progression after prior therapy and must have no therapy available that is likely to provide clinical benefit. An interval of at least 12 weeks after prior radiotherapy is required unless there is either histopathological confirmation of recurrent tumor or new enhancement on MRI outside the radiotherapy field. Participants who are intolerant of or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
• Baseline archival tumor specimen less than 24 months from date of screening. Must be a tumor block or a minimum of 15 unstained slides from biopsy or resection of primary tumor or metastasis.
• Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:

• Prior receipt of a selective FGFR inhibitor.
• Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of study drug. Participants must have recovered (≤ Grade 1 as per CTCAE v5.0 or at pretreatment baseline) from AEs from previously administered therapies (excluding alopecia).
• Participants may have had treatment for an unlimited number of prior relapses but must not have had prior bevacizumab or other VEGF/VEGFR inhibitors (exception: prior bevacizumab is allowed if it was administered for the treatment of radiation necrosis rather than progressive tumor and was stopped at least 12 weeks prior to MRI showing tumor progression).
• Concurrent anticancer therapy (eg, chemotherapy, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
• Candidate for potentially curative surgery.
• Dexamethasone (or equivalent) > 4 mg daily at the time of study registration (higher doseof steroid for symptom control is allowed during the study).
• 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 macular/retinal degeneration, diabetic retinopathy, and retinal detachment) as confirmed by ophthalmologic examination.
• Diffuse leptomeningeal disease.
• Radiation therapy administered within 12 weeks before enrollment/first dose of study drug. An interval of at least 12 weeks after prior radiotherapy is required unless there is either histopathological confirmation of recurrent tumor or new enhancement on MRI outside the radiotherapy field.
• Known additional malignancy that is progressing or requires active systemic 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 defined laboratory values at screening.
Drug: Pemigatinib
Glioblastoma, Adult-type Diffuse Gliomas
glioblastoma, GBM, adult-type diffuse gliomas, gliomas, oligodendroglioma, FGFR1-3 Alteration, FGFR1-3 fusions, FGFR1-3 rearrangements, Central nervous system tumor, isocitrate dehydrogenase, IDH-mutant astocytoma, IDH-wild-type GBM
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COCOA

Among people with peripheral artery disease (PAD) age 55 and older, we will test the hypothesis that PAD participants randomized to cocoa flavanols will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. We will randomize 190 participants (32 in Minnesota) with PAD age 55 and older to one of two groups for six months: cocoa flavanols vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are six-month change in maximal treadmill walking distance, Actigraph-measured physical activity, whole body oxygen consumption, measures of nitric oxide (brachial artery flow-mediated dilation (FMD)), calf muscle endothelial nitric oxide synthase (eNOS) and phosphorylated eNOS, calf muscle perfusion (measured by magnetic resonance imaging (MRI)) and calf muscle characteristics (measured by calf muscle biopsy). To achieve our specific aims, we will randomize 190 participants age 55 and older with PAD to one of two groups: cocoa flavanols vs placebo. Participants will be followed for seven months.

Diane Treat-Jacobson
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT04794530
STUDY00012373
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Inclusion Criteria:

• Age 55 and older
• Presence of peripheral artery disease (PAD). PAD will be defined as either an ABI <= 0.90 at baseline or vascular lab evidence of PAD or angiographic evidence of PAD.
Exclusion Criteria:

• Unable to tolerate study pills
• Inability to walk or requiring walker to ambulate
Peripheral Artery Disease
cocoa, cocoa flavanols, intercede, pad, peripheral artery disease, prove
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Early Intervention for Very Low Birth Weight Infants: Equity and Neurodevelopment (EVEN Study)

This study uses parental surveys and standard neurodevelopment testing to better understand the experience of families of very low birth weight infants with early intervention services in Minnesota. We are particularly interested in understanding how inequity, bias, and discrimination contribute to disparities in neurodevelopment outcomes for this population.

Anita Randolph
up to 18 Years old
NA
This study is NOT accepting healthy volunteers
PEDS-2021-30520
STUDY00014475
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Inclusion Criteria:
Birthweight < 1500 grams; Minnesota resident
Exclusion Criteria:
Cardiac defect; genetic abnormality
Brain & Nervous System, Children's Health
Prematurity, low birthweight, neurodevelopment
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