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A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis.

A study that looks at the efficacy of Frexalimab compared to placebo in adults with nonrelapsing secondary progressive MS.

This study explores the efficacy and safety of Frexalimab compared to placebo in delaying disease disability progression in non-relapsing secondary progressive multiple sclerosis (nrSPMS). There will be about 53 in person visits over 4.5 years that consist of monthly IV medication administration, vitals, monthly blood draw for lab work, clinical outcome assessments, ECG, and Magnetic resonance imaging (MRI) roughly every 6 months. All study activities will be done at the Penn State Health Hershey Medical Center in the Neurology Clinic at 30 Hope Drive and Clinical Research Center (CRC) in the main hospital.

Up to $4300

Yes
 

Jikku Zachariah
Reba Chivari - at rchivari@pennstatehealth.psu.edu or 717-531-0003, ext=283114
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06141486
STUDY00026060
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Inclusion Criteria:
Ages 18-60
Previous diagnosis of remitting relapsing multiple sclerosis (RRMS) AND absence of clinical relapses for at least 24 months
Current diagnosis of secondary progressive multiple sclerosis (SPMS) and documented evidence of disability progression observed during the 12 months before screening
Must agree to use contraception for male and female participants
Must be able to sign informed consent or have a legally authorized representative (LAR)

Exclusion Criteria:
History of infectious disease/serious psychiatric illness/active substance use disorder/cirrhosis, acute liver disease/malignancy/autoimmune, cardiovascular, neurological disorders/any other history or presence of significant other concomitant illness.
Treatment with lymphoid irradiation, bone marrow transplantation, mitoxantrone, alemtuzumab, cladribine, daclizumab, cyclophosphamide, other strongly immunosuppressive treatments with very long-lasting effects.
Previous exposure to frexalimab, other investigational drug trials, allergy or sensitivity to any of the study interventions.
Contraindication for MRI: pacemaker, metallic implants/presence of metallic material in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
Neurology
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Hershey, PA ,

PSCI 24-106: A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) Vs (Daunorubicin And Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, And (Daunorubicin And Cytarabine) Liposome + Venetoclax In Patients Aged 59 Or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined By Myelomatch; A Myelomatch Clinical Trial

This study is being done to answer the following question: Can we shrink the amount of AML or get rid of it in your bone marrow and body by treating you with the standard approach of cytarabine + daunorubicin (7+3) or one of the following experimental groups: 1) cytarabine and daunorubicin with venetoclax 2) azacitidine and venetoclax, 3) daunorubicin and cytarabine liposome, or 4) daunorubicin and cytarabine liposome with venetoclax?Study will last 5 years. After study treatment, doctor will continue to follow condition for 5 years and watch for side effects. The follow-up care may be in-person clinic visits or phone calls. They will check subject every month for 1 year after they join the study. After that, they will check subject every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth and fifth years.

Study will last 5 years. After study treatment, doctor will continue to follow condition for 5 years and watch for side effects. The follow-up care may be in-person clinic visits or phone calls. They will check subject every month for 1 year after they join the study. After that, they will check subject every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth and fifth years.

Yes
 

Joseph Cioccio
PSCI Clinical Trials Office at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05554406
STUDY00026191
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Inclusion Criteria:
Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study.
Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per WHO criteria
Participants must have high-risk (adverse) AML per ELN 2017 criteria.
Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per WHO criteria

Exclusion Criteria:
Acute promyelocytic leukemia is excluded.
Participants with favorable or intermediate risk disease are excluded.
Participants with FLT3 mutations (ITD or TKD) are excluded.
Participants with t(9;22) translocation are excluded.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)

This study is being done to answer the following question: Will preventative radiation therapy lower the number of bone metastases-related complications (such as fracture caused by the tumor in the bone and tumor pushing on the spinal cord) compared to the usual approach?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your type of cancer. The usual approach is defined as care most people get for high-risk bone metastases that are not causing symptoms.

If the participant decides to take part in this study, they will either get the usual approach or they will get radiation therapy for up to 5 days plus the usual approach.After the participant finishes treatment, the doctor and study team will continue to follow their condition and watch for side effects. The doctor and study team will check the participant 3, 6, 12, and 24 months after they join the study.

Yes
 

Aruna Turaka
PSCI Clinical Trials Office at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06745024
STUDY00027090
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Inclusion Criteria:
Patients with polymetastatic cancer defined as more than 5 sites radiographically-evident systemic metastatic disease (excluding intracranial disease).
“High-risk” asymptomatic bone metastasis(es)
Patients with any solid tumor type (excluding multiple myeloma)
Patients must have systemic disease evaluation through standard of care diagnostic imaging, including either CT chest/abdomen/pelvis or body PET/CT, with radiology report available.
Patients with treated brain metastases and no known leptomeningeal disease are eligible if these lesions have been treated prior to enrollment.

Exclusion Criteria:
A patient cannot be considered eligible for this study unless ALL of the above conditions are met.
Cancer
Approved drug(s)
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Hershey, PA ,

Uncovering Barriers in Clinical Trials for Cancer Care in the Penn State Cancer Institute patient population – survey feasibility study

This a pilot study that will evaluate the feasibility of assessing perceived barriers to accessing clinical trials in the PSCI patient population through a questionnaire.

Patient need to fill out a survey about accessing clinical trials to the best of their ability.

Yes
 

Monali Vasekar
Anne-Laure Strong - at astrong1@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00027071
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Inclusion Criteria:
18 years of age or older
Speak and write English
Have a history of cancer (both liquid and solid tumors)
Currently receiving or have received any form of systemic therapy for cancer at PSCI
Be treated at least in part at Penn State Hershey Cancer Institute for cancer

Exclusion Criteria:
Participants not meeting any inclusion criteria.
Cancer
Survey(s)
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Hershey, PA ,

User Perspectives on Usability and Noise of Common Luxury Multi-styler Devices: A Survey Study

We will ask people who currently use—or have used—hair-styling tools (e.g. Dyson Airwrap, Shark Flexstyle) to complete an online questionnaire about how easy the tools are to use and how loud they seem. Our goal is to understand user experiences and preferences so manufacturers can design quieter, more user-friendly devices.

There will be an online consent form and an eligibility questionnaire before an approximately 10 minute survey on Qualtrics.

No
 

Trisha Munyon
txm5437@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00027136
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Inclusion Criteria:
18 or older.
Under age 60.
No diagnosed hearing impairments.
Shoulder length or longer hair in past 12 months.
Have used luxury multi-airstyler devices in past 12 months.

Exclusion Criteria:
Over 60 years old.
Under 18 years old.
Does not read English.
Diagnosed hearing impairment.
Have never used one of luxury multi-airstyler devices in question.
Prevention, Mental & Behavioral Health, Women's Health
Not applicable
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PSCI 24-073 TRANSPARENT: Single-Arm Study of Toripalimab in Combination with Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants

Participants will be required to come to all study visits. At those visits the following may occur, blood tests to see if you are well enough to participate or continue to participate in the trial, a physical exam by the study doctor, meeting with the study team to talk about how you are feeling followed by getting toripalimab and chemotherapy. At other time you will need to have scans to see if how your cancer has responded to the treatment. These visit will continue until your cancer grows back, doesn’t respond to the treatment or the study is stopped by the sponsor. Although toripalimab is approved for the treatment of NPC, it is not approved to be used with these other two drugs.

Participants will be required to come to all study visits. At those visits the following may occur, blood tests to see if you are well enough to participate or continue to participate in the trial, a physical exam by the study doctor, meeting with the study team to talk about how you are feeling followed by getting toripalimab and chemotherapy. At other time you will need to have scans to see if how your cancer has responded to the treatment. These visit will continue until your cancer grows back, doesn’t respond to the treatment or the study is stopped by the sponsor.

Yes
 

Danh Pham
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06457503
STUDY00026410
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Inclusion Criteria:
Adults only 18 years of age or older.
Recurrent/metastatic or recurrent NPC after curative treatment.
Measurable disease

Exclusion Criteria:
Disease that is suitable for local therapy administered that could be cured
Prior therapy administered in the recurrent or metastatic setting
Rapidly progressing disease
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,