Search Results
Emotion Regulation and Mother-Infant Synchrony
The aim of this study is to better understand emotion regulation in infants by measuring brain, behavior, and mother-infant relational mechanisms. We plan to collect simultaneous brain activation in mothers and infants while they engage in a face-to-face interaction. We will then test associations between individual brain activation, mother-infant brain synchrony, and infant emotion regulation behaviors.
Participants complete questionnaires online, then come in for 1 in-person visit. Mother and baby complete a play and a neutral task while fNIRS is collected from them simultaneously.
40
Infants born 3 weeks within their due date.
Infants of a birth weight > 2500 g.
Infants with NO serious medical complications.
English-speaking families.
Infants who experienced any serious medical complications.
Infants who were born > 3 weeks before the indicated gestational period.
Families who do not understand and do not speak English
Predicting Concussion Outcomes with Salivary miRNA
The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid (miRNA) expression that are predictive of symptom duration and severity following mild traumatic brain injury (mTBI) in children. The primary endpoints of this study are as follows: 1) Characterization of brain-related miRNA in the saliva of 250 children with mTBI and 200 age- and gender-matched controls between the ages of five and twenty-three years. 2) Identification of a set of salivary miRNAs that is predictive of duration and severity of mTBI symptoms.
Saliva collection and surveys at baseline, 7 days, and 30 Days
$20
Seen in the Penn State Pediatric Concussion Clinic within 2 weeks of most recent concussion
Periodontal disease
Ongoing seizure disorder, or other neurologic disorder
Drug or alcohol dependency
clinical diagnosis of severe TBI
PSCI-22-063: NRG-GU011 NRG Promethean
This trial is comparing radiation therapy with or without hormone therapy in men with prostate cancer.
Patients must come in for all radiation treatments. Patients must take their androgen therapy as prescribed.
Age ≥ 18 years.
ECOG Performance Status 0-2 within 120 days prior to registration.
External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
Currently on androgen deprivation or anti-androgen therapy.
Osseous metastasis on 99mTc radionuclide bone scan
Extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
PSCI 24-079 THE PHASE III ‘HIGH FIVE TRIAL’ FIVE FRACTION RADIATION FOR HIGH-RISK PROSTATE CANCER
This trial is comparing disease free survival using standard radiation versus higher doses of radiation to the prostate to prevent the cancer from spreading.
Participants will be chosen to enroll into one of two types of radiation to treat their prostate cancer. they must agree to keep all appointments over the 5 years period and agree to be contacted every year for follow up.
High-risk disease
Prostate gland volume less than 100 cc prior to initiation of ADT
o definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18
No prior radical prostatectomy;
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration;
Understanding the effect of drivers’ profile information on riders’ feedback in ride-sharing context
This study aims to understand ways to affect how riders perceive and provide feedback to drivers through technology intervention. Particularly, we investigate how presenting drivers’ personal profile under different trip conditions may lead to differences in the ways riders may provide feedback. We hypothesize that riders will provide positive feedback when provided drivers’ personal information when the trip goes well, and that riders will provide less negative feedback when provided drivers’ personal information when the trip goes bad due to uncontrollable reasons.
You are willing to share several of your past Uber/Lyft trip records in the app with us.
Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
This protocol has two independent parts. In Part 1, participants will be randomized to one of three Tulisokibart arms of treatment or placebo. Tretment will include induction, maintenance, and extension. When the maximum number of participants with prior exposure to advanced therapies has been reached, Part 2 will open for enrollment. In Part 2, the participants will be randomized to one of two dosing arms of Tulisokibart or a placebo.
The participants will be required to sign the inform consent and understand the requirements. They must have in person visits, comply with the procedures (blood test), colonoscopy, and to complete daily dairy about their symptoms. They must provide specimens such as blood, stool, and urine.
$100 per completed visit, $250 per endoscopy
Individual of any sex/gender from 18 years to 75 years of age inclusive,
Has had disease more than 3 months and has moderately active disease with one of the standard therapies
Average daily very soft or liquid SF ≥4 and/or average daily APS ≥2 at Baseline.
Demostrates loss of response, intolerance or inadequate response to standard therapy
Has CD without colonic involvement
Has known colonic stricture or colonic stenosis
Has current stoma
Is missing more than two colonic segments or has short bowel syndrome
PSCI# 25-018 Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard of Care Treatment for Resectable State II/IV Cutaneous Squamous Cell Carcinoma
This study is comparing standard of care surgery and after surgery radiation against pre-surgery immunotherapy, followed by surgery, followed by radiation and immunotherapy to determine which combination prevents cancer reoccurrence.
Participants must come to all scheduled study visits, all medications they are taking including over the counter and tell the study doctor how you are feeling. 7 visits; 3 blood draws; QOLs to be completed 5 times for Group 1 and 7 times for Group 2
Previously untreated or recurrent CSCC
Age ≥ 18
ECOG Performance Status of 0-2
Not Pregnant and Not Nursing
No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
No history of allogeneic stem cell transplantation, or autologous stem cell transplantation.
No prior systemic therapy for the study cancer
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous Sarcoidosis
The purpose of this research is to measure clinical safety and efficacy (effectiveness) of oral brepocitinib in adults with cutaneous sarcoidosis. Participation in this study is expected to last for up to 24 weeks (about 6 months). During treatment period, visits will be scheduled about every 4 weeks. Participants will be assigned to 1 of 3 treatments, there is a chance of receiving a placebo (non active ingredient treatment) however, you will not know nor will the study team know what treatment you have been assigned too. In addition, throughout the study at different time points you will answer questions, take the study treatment as directed by the study team, have your skin examined (biopsy), have labs drawn, have an ECG, and a chest x-ray.
Participants will attend a total of 7 in person visits throughout the study and visits will be scheduled about every 4 weeks during the Treatment Period. During the study you will be asked to answer questions to gather information on your health as well have you complete questionnaires. In addition, you will have the following assessments at different time points throughout the study: skin exam, ECG, Chest X-Ray, Skin photography, Skin punch biopsy, Pulmonary function testing, and blood tests.
Skin biopsy required along with presentation of cutaneous sacroidosis symptoms for 6 months or longer
Weight requirements apply for participation, study coordinator will discuss
Must be willing to understand and comply with the study requirements
Certain medications are allowed at a maximum stable dose, study coordinator will discuss further
Women who are breastfeeding, pregnant, or planning to become pregnant, or WOCBP who are unwilling to apply a highly effect birth control method for the time specified during study participation
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBEXELIMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
Study to look at the safety and effectiveness of Obexelimab in patients with active Lupus who are currently receiving standard of care medications
There will be 13 in person visit over nine months, blood and urine will be obtained at 12 of these visits.
up to $650
over 70 years old
PSCI 24-106 A: A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial
As part of the myeloMATCH Older Adult AML basket, a comprehensive geriatric assessment will be implemented across intensive and non-intensive treatment studies to validate measures of fitness and frailty that predict for treatment-related morbidity and mortality. The overall goal of the geriatric assessment will be to validate measures to be incorporated in future older adult AML myeloMATCH studies to prospectively define “fitness” for intensive chemotherapy.
Subject will either get Azacitidine through a vein in their arm or subcutaneously and Venetoclax by mouth for up to 2 years, or will get Azacitidine through a vein in your arm or subcutaneously, Venetoclax and Gilteritinib as tablets that you take by mouth for up to 2 years. After you finish your study treatment, doctor will continue to follow condition for 10 years.
Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible.
Patient must be assigned to this protocol by the myeloMATCH MSRP.
Patient must have the ability to understand and the willingness to sign a written informed consent document.
Creatinine clearance of ≥ 30 mL/min/1.73m2
Patient is pregnant or breast-feeding
Patients with a history of hepatitis C virus (HCV) infection have not been treated and cured.
Patient has the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug.
PSCI 24-129 Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects with Selected Relapsed/Refractory B cell Malignancies
This trial will examine the use of "off the shelf" CAR T in the treatment of cancers that have relapsed or do not respond to treatment.
Participants must keep all study visits, tell the study doctor how you are feeling and all medications you are taking including over the counter medications.
Must have prior biopsy proven confirmed diagnosis of DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL, and tFL or follicular lymphoma Grade 3B.
Must have relapsed/refractory disease
Must be willing to practice birth control
Concurrent or previous other malignancy within 2 years of study entry
Has active autoimmune disease
Has a history of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection
PSCI 24-106: Myelomatch, Master Screening And Reassessment Protocol (MSRP) For Tier Advancement In The NCI Myelomatch Clinical Trials
The purpose of the study is to see if blood and bone marrow samples can be tested in a timely manner for markers that could guide cancer treatment. The testing will look for markers that specific treatments may target. Based on test results, the subject will have the option to join a myeloMATCH treatment substudy for treatment or receive standard of care treatment from your doctor.
Participants will give bone marrow and blood samples for testing. Your samples will be tested for specific cancer biomarkers. After the study receives the results of your biomarker testing, the physician will tell you if there is a myeloMATCH treatment substudy available that matches your results. If a substudy is available the study doctor will give the subject more information about it and help the subject understand the details of the study.
Participants must be ≥ 18 years of age.
Participants must agree to have translational medicine specimens submitted per
Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy.
Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration
Participants are less than 18 years of age.
Participants did not agree to have translational medicine specimens submitted per
Participants have a prior or concurrent malignancy that requires concurrent anti-cancer therapy.
Participants did not have a Zubrod Performance Status evaluation within 28 days prior to registration
Cue Reactivity Responses in Alcohol and Cannabis Use
This study aims to examine how alcohol and cannabis cues (i.e. images of alcohol containing beverages or cannabis) influences brain responses in the lab and how cues in the natural environment influence self-reported craving and drug use.
Potential participants will complete a screening questionnaire over the phone, and if eligible, will also complete 3 in-person visits. These visits include an intake session in which eligibility is assessed, a MRI session, 2 weeks of smartphone based responding, and a third visit to complete a questionnaire.
$279
Able to read and write in English and complete study evaluations
Able to provide written and verbal consent
Must report regular use of alcohol and/or cannabis
Able to provide negative toxicology screenings for substances, except cannabis, nicotine, or alcohol prior to eligibility determination
Current regular illicit drug use (other than cannabis)
Any contraindications for MRI
PSCI #24-150 A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).
This study will see if pembrolizumab alone or with PDS0101 is the better treatment for head and neck cancer.
Participants will need to come to all study visits, take the study medication as prescribed, tell the study team how you are feeling and report to the study team all new medications you are tsking including over the counter medications.
Have a history of histologically- or cytologically-confirmed diagnosis of recurrent and/or metastatic squamous cell cancer of the head and neck
Subject has adequate organ function
Has had major surgery, including surgical resection of tumor, within 30 days prior
Has received radiotherapy prior
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants with Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations
Cutaneous lupus erythematosus is an autoimmune condition that causes red, scaly plaques on the skin, often in sun-exposed areas. Complications of cutaneous lupus erythematosus (CLE) include changes in skin pigment, scarring, disfigurement, fatigue, and reduced quality of life. There are no medications currently approved for the treatment of CLE. The purpose of this study is to find out of the study medicine, IMVT-1402, can help with the treatment of CLE.
Total duration of the study is approximately 63 weeks, with up to 55 visits (approximately 1 visit per week). 16 visits will occur in person and 39 visits will be phone call visits. Procedures involved in the study include: medical history collection, physical exams, skin assessments, skin biopsy, photographs, electrocardiogram (ECG), blood draws (at up to 15 visits), urine tests, and questionnaires.
At least 18 years old
Willing to follow all study guidelines
History of HIV or other immunodeficiency
Pregnancy or breastfeeding
Whole blood from healthy volunteers
This research is being done to find out what triggers an immune response in white blood cells. For example, understanding the triggers of the individual interferon responses may lead to future therapies that are more selective for treating an exaggerated immune response.
A single visit for a whole blood sample.
$30.00
18 yrs of age or older
No skin or systemic inflammatory disease
Willing to undergo a 1-time blood collection
Subjects who are currently pregnant
Subjects who have an autoimmune or inflammatory disease
Impact of brief daily functional resistance training on lower extremity physical performance
Our research study is testing a brief exercise program designed to help older adults walk better. The exercise program is done from the comfort of the participants' home for only 5 minutes a day!
Meet with an exercise coach virtually via Microsoft Teams Come to Penn State Hershey Medical Center 3 times for appointments Wear a physical activity monitor 3 times Complete surveys
115
Serious difficulty walking 3 blocks
Computer, iPad, smart phone with a camera
Participating in another research project involving physical activity, falls or weight loss
Inability to walk 10 feet without an assistive device
Pain in chest when doing physical activity
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.
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
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.
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.
“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.
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.
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
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.
Recurrent/metastatic or recurrent NPC after curative treatment.
Measurable disease
Prior therapy administered in the recurrent or metastatic setting
Rapidly progressing disease
Rocking the foundation: Controlled whole-body vibration training for strength, balance, and gait performance in middle-aged adults.
Testing the effects of low-impact vibration training vs. body squats only on strength, balance, and walking outcomes in people aged 40-65 years.
There will be one study visit lasting approximately 2.5 hours. Following a short screening and consent process, study participants will complete a series of baseline tests to acquire information about body composition, walking ability, strength, and balance. Participants will then complete a workout consisting of vibration training group or a squats only. Each workout will last approximately 10-minutes. The tests will be repeated to assess any changes resulting from the training.
$25.00
Participants must have no known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment that may affect their ability to perform the testing procedures will be included.
Participants will be male and female between the ages of 40 and 64.
Participants must not use a pacemaker.
Participants must be able to stand and walk independently with or without the aid of an assistive device.
A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
RO7790121 will be used in the adult patients with Ulcerative colitis, to find out if it is safe and efficient in treatment of ulcerative colitis. The subjects will receive either RO7790121 drug or a placebo. After 12 weeks, the participants who complete treatment can continue to the open label treatment and receive a drug. Induction will consist of about eleven visits to the study site. The subjects will receive four intravenous treatments of either a drug or the placebo.
All subject must show understanding of the study requirements and sign the informed consent. The participants will have study procedures done, such as colonoscopy with biopsies, blood draws, and if eligible, they will be randomized at the start of induction treatment. The treatment will consists of the study drug or placebo. They will receive treatment by infusion in five study visits. After twelve weeks, the patience will be evaluated and they could continue to the open label treatment.
$75 per completed visits including endoscopy, and up to $50 for travel compensation for completed visit. You can receive a total of $1380.00 for your participation in the study.
Age from 18 to 80 years at the time of signing
Bodyweight more or equal than 40 kg
Confirmed diagnosis of UC
Must have had at least one of the standard treatments in the past with inadequate response, loss of response, and/or intolerance
Presence of ostomy or ileoanal pouch
Diagnosis or suspicion of primary sclerosing cholangitis.
Any major surgery within 6 weeks prior to screening
Evidence of or treatment for Clostridioides difficile (C. difficile)
Midlife Vascular Health Study
Several easy methods will be used to study how blood vessels change in middle-aged people. These methods include heating a small spot on the arm, using a small TENS unit, using an ultrasound with a blood pressure cuff on the arm, and taking a blood sample.
There will be 2 in-person visits, one will be ~1 hour, the other will be ~2. We will take a blood sample at each visit. The second visit will require you to be seated and resting the entire time.
75
nicotine use
current or recent hormone replacement therapy
bleeding disorders
beta-blockers or alpha-blockers
The impact of structural racism and discrimination on chronic pain in Black or African American older adults: Biopsychosocial mechanisms
This study is trying to understand more about factors that cause pain in people who have had experiences of discrimination.
2 in-person visits 3-4 hours each plus at-home online questionnaires In-person visits will involve: 1. Sensory and pain testing 2. Physical function testing 3. Blood draw 4. MRI scan 5. Questionnaires
Up to $250
Identify as Black or African American
Chronic pain in knee or lower back
High blood pressure NOT controlled with medication
Unable to have an MRI scan
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema – ALPHA-ORBIT
The purpose of this study is to evaluate the effectiveness and safety of navenibart as a preventative treatment for people with Type I or Type II Hereditary Angioedema (HAE).
You will need to come to Penn State Health Milton S. Hershey Medical Center 8 times. You will answer questions about your health/HAE attacks, provide blood samples, undergo routine urine laboratory tests, receive the trial drug, undergo electrocardiogram (ECG), complete questionnaires, undergo physical exams, and provide HAE attack information.
Diagnosis of hereditary angioedema Type 1 or Type 2
Agree not to receive a dose of any vaccine within 7 days before or after trial medication administration.
History of chronic viral infection with positive test for HIV or hepatitis B surface antigen; history of hepatitis C virus that has not been adequately cured
Active liver disease
History of drug or alcohol abuse in the 12 months before Screening.
A sample repository for the examination of biomarkers for Amyotrophic Lateral Sclerosis (ALS) and other Motor Neuron Diseases
A sample repository for the examination of biomarkers for Amyotrophic Lateral Sclerosis (ALS) and other Motor Neuron Diseases
Participants will be asked to donate blood one or more times and provide age, sex and general history of neurological disease. ALS/motor neuron disease patients will be asked to release information from the medical record about their neurological disorder, strength, function, treatments, known pathogenic ALS-related gene variants, quality of life, and results of breathing tests.
PSCI 24-132 A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
This trial will examine the outcome of comparing Sonrotoclax Plus Zanubrutinib vs. Zanubrutinib alone in the treatment of mantle cell lymphoma
Participants must come to all study visits, take the medication as instructed, tell the study how you are feeling and tell the study team about any medications you are taking, especially over the counter medications.
Received 1 to 5 prior lines of systemic therapy
Relapsed or refractory disease after the last line of therapy
Age ≥ 18 years.
Prior allogeneic stem cell transplant within 6 months of the first dose of the study treatment
Known central nervous system involvement by lymphoma
A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
This study is for participants who have a brain tumor and decide with their doctor to use GammaTile radiation therapy to treat their brain tumor. This treatment is FDA approved. The purpose of this study is to collect data on how this treatment impacts your health and wellbeing.
There are no required visits or treatments for this study. At your regularly scheduled doctor visits, your study doctor or staff will enter relevant health and medical information into the study database. You will also be asked to complete questionnaires about the quality of your life during your routine medical appointments.
Willing and able to provide informed consent and to participate in all evaluations.
Major medical or psychiatric illness, which, in the investigator’s opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups.
Lack of English or Spanish language fluency sufficient to allow for providing informed consent and for completion of QOL tests all of which are available in English and Spanish.
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults with Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study
Each participant will have a maximum study participation of 61 weeks, which includes a total duration of study treatment approximately 52 weeks: Period 1 (double-blind, placebo-controlled treatment; 16 weeks) and Period 2 (double-blind, active treatment; 36 weeks). At different timepoints throughout the study subjects will have their skin examined, have labs drawn, have an ECG perfomed, as well as answer questionnaires.
Study participation will last approximately 56 weeks. During the study, participants will attend 20 in person visits in the research office. At different timepoints the participant will have their skin examined, blood drawn, have an ECG done, answer questionnaires and take study medication as directed by the study team.
Participants must have active HS in at least 2 different body areas
Contraceptive/Barrier Requirements for participation will be discussed
Known history of HIV infection (HBV & HCV diagnosis will be discussed during screening process)
Certain dental conditions are not allowed; study coordinator will discuss
Certain HS medications are not allowed; study coordinator will discuss