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

20 Study Matches

Site For AbbVie- HS Surgery

Site For AbbVie- HS Surgery
Logan Claar at lclaar@pennstatehealth.psu.edu or 717-531-5136
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Must be able to travel to Hershey Medical Center for 12 visits
Must be diagnosed with HS for 1 year prior to study participation
Must be willing to perform self injections at home
Exclusion Criteria:
Prior treatment of Humira or other biologics for the treatment of HS
Skin Conditions
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Hershey, PA

A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC) (PSCI 18-112)

This study is a comparison of disease-free survival of patients with high-risk cutaneous squamous cell carcinoma (CSCC) when treated with a medication (cemiplimab) versus those treated with placebo after already having surgery and radiation therapy.
Irina Geier at igeier@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03969004
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Inclusion Criteria:
High risk cutaneous squamous cell carcinoma
Post resection and curative intent post-operative Radiation Therapy within 2 to 6 weeks of randomization
Adequate hepatic, renal, and bone marrow function as defined in the protocol
Exclusion Criteria:
Patients with blood cancer (hematologic malignancies) or other malignancies
Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
Significant autoimmune disease that required treatment with systemic immunosuppressive treatments (including corticosteroids)
Has had prior systemic anti-cancer immunotherapy for cutaneous squamous cell carcinoma
Cancer
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Hershey, PA

Site for EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response (PSCI# 20-099)

The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
Doris Shank at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04266249
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Inclusion Criteria:
Histologically confirmed HER2-positive primary invasive breast carcinoma
Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or > 50%).
Exclusion Criteria:
Patient must not have a history of any prior (ipsilateral or contralateral) invasive breast cancer.
Patient must not have Stage IV (metastatic) breast cancer
Patient must not have T4 and/or N3 disease, including inflammatory breast cancer.
Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
Patient must not have a concurrent serious medical condition that would preclude completion of study therapy.
Cancer
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Hershey, PA

The Use of Micro-Doppler Radar to Identify Service Members at Risk for Musculoskeletal Injury: A Gold Standard Comparison

The purpose of this research study is to see if we can use micro-doppler signal technology to determine if someone has had an ACL reconstruction in the past. We will do this by comparing a group of people who have had the surgery against a group who has never had this surgery to see if this technology can tell the difference.
Cayce Onks at conks@pennstatehealth.psu.edu or 717-531-8187
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Ages 18-40
ACL Group: ACL Reconstruction surgery 9-24 months prior and approved to return to normal activities
Control group: No history of lower extremity surgery
Able to provide consent and read/write in English
No current musculoskeletal injuries
Exclusion Criteria:
Prisoner
Pregnant person
Below age 18 or above Age 40
Unable to provide consent or read/write in english
Unable to perform movements consistent with daily activities such as jogging, jumping, or moving from sit to stand
Prevention, Sports Medicine, Muscle & Bone
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Hershey, PA

E4512- A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Purpose of this study is to compare any good and bad effects of using the study drug, crizotinib after completeion of surgery and in some cases after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer.
Michelle Eschbach at meschbach@pennstatehealth.psu.edu or 610-378-2336
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02201992
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Inclusion Criteria:
Patients must have undergone complete surgical resection of their
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE
ALK positive
Patients must have completed any prior adjuvant chemotherapy or
Exclusion Criteria:
No prior treatment with crizotinib or another ALK inhibitor.
Cancer
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Reading, PA

Site for EA2197: Optimal Perioperative Therapy For Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial (PSCI# 21-111)

The purpose of this study is to compare the usual treatment (surgery plus chemotherapy after) to using chemotherapy both before and after surgery. Receiving gemcitabine/cisplatin chemotherapy both before and after surgery could extend your life and prevent your cancer from returning. But, it could also cause side effects, which are described in the risks section below. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will look to see if the chemotherapy increases the time to disease recurrence and if it increases a patient’s overall survival compared to the usual approach given both before and after surgery.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04559139
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Inclusion Criteria:
Patient must be = 18 years of age.
Patient must have an ECOG performance status of 0-1.
Patient must have undergone initial cholecystectomy within 12 weeks prior to randomization
Patient must have histologically-confirmed T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease
Exclusion Criteria:
Patient must not have any evidence of metastatic disease or inoperable loco-regional disease based on high-quality, preoperative, cross-sectional imaging (CT or MRI) of the chest, abdomen, and pelvis (C/A/P) obtained within 6 weeks prior to randomization
Women must not be pregnant or breast feeding due to the potential harm to unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
No radiographic evidence of distant disease (M1 disease)
No radiographic evidence of tumor invasion into multiple extrahepatic organs (T4 disease)
No radiographic evidence of distant lymph node involvement (celiac, para-aortic, para-caval lymph nodes)
Cancer
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Hershey, PA

Site for RANDOMIZED PHASE II/III TRIAL OF SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOR EARLY-STAGE ORAL CAVITY CANCER (NRG-HN006) (PSCI# 20-085)

The purpose of this study is to see if neck and shoulder function and pain are better after SLN biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. SLN biopsy surgery is potentially less invasive compared to the usual approach, but it requires a radioactive imaging agent to see the lymph nodes and it could also cause side effects. These side effects are described in the risks section below. Your study doctor will choose the appropriate imaging agent, Lymphoseek or sulfur colloid, for use in your surgery. This study will help the study doctors find out if this different approach is better than the usual approach at improving neck and shoulder function. To decide if it is better, in the first part of the study, doctors will be looking to see if shoulder and neck function and quality of life are better after SLN biopsy surgery compared to the END surgery.
Tricia Morrison at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04333537
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oral cavity
Age ≥ 18
Zubrod Performance Status 0-2 within 42 days prior to registration
Only English speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language
For women of child bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
Exclusion Criteria:
Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
Incomplete resection of oral cavity lesion with a positive margin; however, an excision biopsy is permitted
Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.
Cancer
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Hershey, PA

Site for NRG-LU002: MAINTENANCE SYSTEMIC THERAPY VERSUS LOCAL CONSOLIDATIVE THERAPY (LCT) PLUS MAINTENANCE SYSTEMIC THERAPY FOR LIMITED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE II/III TRIAL (PSCI# 21-028)

The purpose of this research study is to compare any good and bad effects of using the usual drug therapy plus radiation with or without surgery to treat the lung cancer and areas of metastasis (where the cancer has spread) compared with the usual drug therapy alone. Two types of radiation delivery will be used in this study. One type is called stereotactic body radiation therapy (SBRT) and will be used to treat areas of metastasis (parts of your body where the cancer has spread). SBRT uses special equipment to position a patient and precisely deliver radiation to tumors in the body. The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. The second type is standard radiation therapy and may be used to treat your primary lung tumor if SBRT cannot be used. Surgery also may be used to treat metastases or your primary lung tumor if you and your treating doctor decide this is a safe and better approach. Radiation, surgery, and usual drug therapy have already been tested for safety; however, using them in combination is not part of the usual approach. Adding radiation with or without surgery to the usual drug therapy could shrink or remove your tumor(s) or prevent the tumor(s) from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual therapy alone approach. Ultimately, to be better, the study treatment should increase life by six months or more compared to chemotherapy alone.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03137771
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Inclusion Criteria:
Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration.
Age = 18;
Zubrod Performance Status 0, 1, or 2 within 30 days prior to registration;
Adequate organ and hematologic/bone marrow function within 14 days prior to registration
Negative serum pregnancy test within one week prior to registration for females of childbearing potential
Exclusion Criteria:
Prior bevacizumab therapy is excluded.
Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration after induction systemic therapy
Cutaneous metastasis of NSCLC;
Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes if not a candidate for surgery for these lesions;
Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year
Cancer
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Hershey, PA

Site for EMPOWER: Endometriosis diagnosis using MicroRNA: PrOspective study in Women to allow Early disease Recognition

This is a multi-center, observational study, the results of which will be used to support marketing for the intended use of the DotEndo investigational diagnostic. DotEndo is a non-invasive in vitro diagnostic test that measures levels of circulating miRNA biomarkers in whole blood. The DotEndo blood test will use a distinct classifier algorithm, based on levels of disease-specific miRNAs, to aid in the diagnosis of active endometriosis disease. The study will enroll women 18 to 49 years old who have been referred to surgery for suspected endometriosis and other benign gynecological indications. Subjects will answer questionnaires and whole blood and saliva samples will be collected prior to and after surgery. Participation is expected to be approximately 3 months with some subjects continuing with annual follow-up post-surgery for 2 years.
Kaedryn DiGuglielmo at kdiguglielmo1@pennstatehealth.psu.edu or 717-531-1510
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04598698
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Inclusion Criteria:
Women aged 18 to 49 years, inclusive,
Scheduled to undergo (within 30 days) either a) laparotomy or laparoscopy for signs and symptoms of suspected endometriosis or b) laparotomy, laparoscopy for another type of gynecologic procedure.
Willing and able to provide up to 50 mL of blood via venipuncture and comply with all other study and sample collection procedures
Exclusion Criteria:
History of surgically determined diagnosis of endometriosis
Is in a pre-menarchal or post-menopausal state, or has been rendered surgically menopausal
Is pregnant or has an active pelvic infection
Has an active malignancy
Is known to have HIV or Hepatitis A, B or C
Women's Health
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Hershey, PA

A Pilot Study to evaluate the pharmacokinetic, pharmacodynamic, and resistance profile to trametinib and dabrafenib in BRAF-V600E mutated recurrent gliomas

This research is being done to understand how much of two drugs (dabrafenib and trametinib) is able to enter brain tumors and how well the drugs are able to turn off this pathway in brain tumors. The study will also look at how tumors lose sensitivity to this treatment. People with primary brain tumors who are already taking dabrafenib and trametinib and who need a brain surgery are eligible for this study. Biospecimens (tissue, blood, and cerebrospinal fluid (CSF)) taken during the surgery will help us understand how much of these two study drugs actually get into the brain, their effect, and how the tumors become resistant to treatment.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
At least 18 years old
Subjects must have a history of primary brain tumor (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), anaplastic ganglioglioma (AG), and anaplastic pleomorphic xanthoastrocytoma (PXA)).
Subjects must have a BRAF-V600 mutation identified in previous tissue analysis (may be IHC or PCR based). Allowable mutations include V600E, V600K, V600R, and V600D.
Subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7 days prior to surgery as prescribed by their treating physician.
Subjects must be undergoing surgery for clinical purposes
Exclusion Criteria:
Younger than 18 year old
Subjects who are receiving any other investigational agents or chemotherapeutic agents.
Neurology, Cancer
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Hershey, PA

GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

The purpose of this study is to see if stool or blood can be used to determine whether or not a patient has any colon polyps or colon cancer. This study will compare these biological samples (blood, urine, stool) to any colonoscopy or surgery a patient has to see if the outcome could be predicted.
Amanda Taylor Gehman at ataylor6@pennstatehealth.psu.edu or 717-531-1283
All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00843375
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Inclusion Criteria:
Adult 18+
Subjects with Colon Cancer or Adenoma
OR subjects undergoing colonoscopy screening
Exclusion Criteria:
Inflammatory Bowel Disease
HIV/Hepatitis
Have had or are receiving chemotherapy or radiation
Have had surgery for your colon cancer
Cognitive Impairment
Prevention, Cancer
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A SINGLE-CENTER, DOUBLE-ARM, PROSPECTIVE CLINICAL TRIAL TO COMPARE VISUAL PERFORMANCE OF NON-DIFFRACTIVE EXTENDED DEPTH OF FOCUS AND NEUTRAL ASPHERIC MONOFOCAL INTRAOCULAR LENSES

Compare the vision of subjects that receive one of two FDA approved intraocular lenses (IOLs) in both eyes, the Alcon Vivity or Bausch & Lomb enVista. You will be followed by research, 1 and 3 months after your second cataract surgery is performed.
Amy Longenecker at alongenecker@pennstatehealth.psu.edu or 717-531-4696
All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04591054
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Inclusion Criteria:
Must need cataract surgery
18 years of age and older
Exclusion Criteria:
History of intraocular or corneal surgery
current ocular infection
serious corneal disease.
Vision & Eyes
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Hershey, PA

Management Of Pain After Cesarean Trial

This is a double blinded, placebo-controlled randomized controlled trial to test the efficacy of a combination of acetaminophen and ibuprofen administered to patients on schedule compared to ibuprofen and placebo on the patient's reported pain score on the second post-operative day after Cesarean delivery. We will also record opiate consumption and pain scores throughout the hospitalization of participants, and will survey patients at one and two weeks after surgery regarding opiate consumption and quality of life.
Female
All
This study is also accepting healthy volunteers
NCT03929640
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Inclusion Criteria:
Pregnant woman
Planned delivery via C-section
Pfannenstiel ("bikini line") skin incision
Able to read and speak English fluently
Exclusion Criteria:
Major intra-operative or post-operative complication such that clinical recommends patient should not receive non-steroidal anti-inflammatory drugs
Unplanned surgery (hysterectomy, bowel/bladder repair, cystoscopy)
Allergy or contraindication to study medication
History of opioid or other substance use disorder either before or during pregnancy
History of kidney or liver disease
Pregnancy & Infertility, Women's Health
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Hershey, PA

A Phase II Study of Adjuvant Treatment With Cisplatin-based Chemotherapy Plus Concomitant Atezolizumab in Patients With Stage I (Tumors ≥ 4cm), IIA, IIB, and Select IIIA [T3N1, T4N0-1] Resected Non-small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA) Big Ten Cancer Research Consortium BTCRC-LUN19-396

Circulating tumor DNA (ctDNA) is genetic material in the bloodstream that comes from the subject's tumor. The purpose of this study is to estimate how many people with measurable ctDNA in the blood at baseline have unmeasurable ctDNA after receiving 1 year of chemotherapy and atezolizumab. Other studies have shown there is a strong connection between having ctDNA in the blood and lung cancer returning. Researchers will test blood from participants five times throughout this study and look for ctDNA. The usual approach for patients who are not in a study is to receive chemotherapy after lung cancer surgery. The goal of chemotherapy is to kill any remaining cancer cells that may be left after surgery. This study will add a drug called atezolizumab to the usual chemotherapy drugs. Researchers think atezolizumab will also help kill any cancer cells that may be left after surgery. In this study chemotherapy and atezolizumab are given as infusions in the clinic once every three weeks. There will be tests, exams, and procedures that are part of subjects' regular care and for study purposes. There will be scans every 3 months to make sure the cancer hasn’t come back. Subjects will receive both chemotherapy and atezolizumab for the first 4 doses (about 2 months). After that, they will continue to receive just the atezolizumab for up to 1 year.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-4300
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04367311
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Inclusion Criteria:
Squamous or non-squamous NSCLC histology
Complete surgical resection of their NSCLC with negative margins
Surgery completed within 60 days prior to starting treatment
Exclusion Criteria:
Small cell or large cell neuroendocrine histology
EGFR mutations and ALK re-arrangements
Prior chemotherapy, radiation therapy, or immunotherapy for lung cancer
Other active cancers
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
Cancer
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Hershey, PA

A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) with Primary Tumors Between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153 (PSCI# 20-043)

This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone. The usual approach for patients who are not in a study is to be followed closely by their doctor to watch in case the cancer returns. Participants in this study will be assigned by chance (flip of a coin) to be watched closely by their doctor or to receive a drug called pembrolizumab. Pembrolizumab is given as an infusion in the clinic once every six weeks. . You will have tests, exams and procedures that are part of your regular care and for study purposes. You will have scans every 12 weeks to make sure the cancer hasn’t come back. If you are assigned to receive pembrolizumab, you can continue to receive it for up to 1 year.
Irina Geier at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04317534
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Inclusion Criteria:
Males and females age ≥ 18 years.
Patients must have undergone complete surgical resection of their stage I non-small cell lung cancer between 4-12 weeks prior to registration.
Pathological tumor size must be 1.0 – 4.0 cm in size.
ECOG Performance Score 0-1
Baseline CT chest must be performed within 28 days of randomization
Exclusion Criteria:
Patients with tumors that are known to harbor actionable EGFR mutations are NOT eligible.
No prior PD-1 or PD-L1 inhibitors are permitted.
No prior neo-adjuvant or adjuvant chemotherapy is permitted for this lung cancer.
Patients with a history of (non-infectious) pneumonitis that required steroids
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Cancer
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Hershey, PA

IMpact of PRehabilitation in Oncology Via Exercise – Breast cancer

It is well known that breast cancer patients suffer from many cancer- and treatment-related side effects that all worsen overall quality of life. Besides dealing with existing treatment-related side-effects, there is the idea of prehabilitation a process on the cancer continuum of care that occurs between the time of cancer diagnosis and the beginning of acute treatment. IMPROVE-B will evaluate an exercise prehabilitation approach with regard to safety, feasibility, acceptability and effectivity in breast cancer patients (n=30) prior surgery.
Joachim Wiskemann at jwiskema@phs.psu.edu or 717-531-0003, ext=289736
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Scheduled for breast cancer surgery
Not metastatic (stage <4)
more than 2 weeks till surgery
Exclusion Criteria:
Receiving neoadjuvant chemotherapy or radiotherapy
Pregnant
• Engaging in systematic intense exercise training (at least 1h twice per week)
Cancer
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Hershey, PA

Metabolic Alterations of the Semitendinosus Muscle After Tendon Harvest for Anterior Cruciate Ligament Reconstruction

This is a cohort study examining the changes in the muscle that occur following ACL injury and reconstruction. This study aims to determine if significant changes to the muscles properties occur as a result of the graft taken for ACL reconstruction, and whether or not these changes serve as a risk factor for further injuries. This study will examine the muscles ability to use oxygen non-invasively, an important determinant of muscle endurance and allow for comparisons of this between individuals with ACL-reconstruction surgery and healthy, non-injured adults.
Jigar Gosalia at jzg691@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
ACL tear within last 12-36 months
Full rehabilitation
autograft taken from hamstring tendon
other autografts may be considered
Recreationally active
Exclusion Criteria:
Other major knee injury (i.e. MCL tear)
Muscle & Bone
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State College, PA

Site for EA8183 A Phase III Study of Early Intervention after RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE) (PSCI# 21-122)

This study is being done to answer the following question: Will the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04484818
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Inclusion Criteria:
Patient must be = 18 years of age.
Patient must have undergone a radical prostatectomy (RP) and must be preregistered to Step 0 of this study at least 6 weeks after but not more than 12 weeks after their radical prostatectomy.
Patient must not have any previous treatment with androgen deprivation therapy (ADT), chemotherapy, or other physician prescribed systemic therapy for treatment of their prostate cancer.
Patient must have an ECOG performance status of 0-2.
Exclusion Criteria:
Patient must not have pathologic evidence of pelvic lymph node involvement.
Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure).
Cancer
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Hershey, PA

A Single Arm, Phase I/II Trial of Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men with Localized, High Risk Prostate Cancer (BTCRC-GU19-404) (PSCI# 21-195)

The purpose of this study is to estimate the efficacy of neoadjuvant androgen deprivation, darolutamide, and ipatasertib in men with previously untreated, localized, high-risk prostate cancer that is lacking PTEN, as measured by the pathological complete response or minimal residual disease. This exact combination of drugs has not been tested in people. However, human studies combining ipatasertib with similar drugs called abiraterone or enzalutamide were found to be safe. Part One of this study tested the safety of combining these three drugs. If that dose is found to be safe in participants, the study will move to the second part. The purpose of Part Two is to answer the following question: can combining a drug called ipatasertib with androgen deprivation therapy (ADT) and a drug called darolutamide for 6 months before surgery cause prostate cancer tumors to completely resolve or almost resolve?
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04737109
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Inclusion Criteria:
Patient has histologically-confirmed diagnosis of localized, untreated prostate cancer with high-risk features
Patient has sufficient archival tissue (at least 2 cores) available for targeted sequencing and immunohistochemistry
Patient has measurable PSA
Patient must be male and >= 18 years of age
Patient must be able to swallow pills
Exclusion Criteria:
Patient has histology of small cell carcinoma prostate cancer. Adenocarcinoma with neuroendocrine features is allowed.
Patient has active infection requiring IV antibiotics
Patient has known additional malignancy that has a life expectancy < 10 years
Patient has distant metastatic disease beyond N1 (regional) lymph nodes on conventional baseline imaging studies within 90 days prior to signing consent
Cancer
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Hershey, PA

Site for Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease. This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.
Kathleen Lehman at KLehman3@pennstatehealth.psu.edu or 717-531-5930
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04620239
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Inclusion Criteria:
New or recurrent low-grade, non-invasive UTUC disease
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing
Exclusion Criteria:
Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
Kidney & Urinary System, Cancer
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Hershey, PA