Search Results
COG AALL1621 - Inotuzumab Ozogamicin in Treating Younger Patients With Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
This Phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.
Consent to treatment, required labs, sample collections, and completion of research study tests.
Patients must have B-ALL, or previously diagnosed B-LL, with ≥ 5% (M2 or M3) bone marrow blasts with or without extramedullary disease.
Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age
Patients with isolated CNS, testicular, or any other extramedullary site of relapse.
Patients who have been previously treated with inotuzumab ozogamicin.
History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study.
Patients with active optic nerve and/or retinal involvement are not eligible. Patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, an MRI to assess optic nerve or retinal involvement.
Neural mechanisms of manual interception
How does the brain decide to reach one way or the other? This study will examine how movement decisions are coordinated by neural mechanisms in the brain during manual interception and reaching actions.
Participants will be required to complete a simple virtual interception task with a handle. Participants will be screened and sign informed consent upon entry of the lab. They will then be fitted with EMG sensors and an eye-tracking reference sticker. They will be seated for this task. The task requires a participant to hold their hand steady at the epicenter of a circle, and reach as quickly and accurately as possible to one of 2 moving targets that will appear.
$20
Right-handed
18-50 years old
Corrected to normal or normal vision
Ability to grasp objects like handle with right hand
Any history of musculoskeletal disorders
Any history of cardiovascular disease
Any increased risk for syncope
Any history of conditions or diseases of the eyes or vision
ANBL1531 Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patient must be ≥ 365 days and ≤ 30 years of age at diagnosis
Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.
Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial).
Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders.
AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma
The overall goal of this study is to compare the effects, good and/or bad, of two different surgery methods for people with OST that has spread to the lung to find out which is better. In this study, participants will receive 1 of 2 treatment plans. Treatment with open surgery is the older standard therapy for people with OST that has spread to the lung. Treatment with VATS is a newer method that has also been shown to work when used to treat the same type of cancer
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must have ≤ 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being ≥ 3 mm and all of which must be ≤ 3 cm size
Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon
Patients must have a histological diagnosis of osteosarcoma
Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
Patients with evidence of extrapulmonary metastatic disease
Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment
Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. N
ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory, or Progressive Neuroblastoma
This phase II trial studies how well irinotecan hydrochloride (irinotecan), temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back or that isn't responding to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines, at the time of initial diagnosis
Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients 16 years of age.
Patients must not have received prior treatment with irinotecan and temozolomide.
Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma
Patients with symptoms of congestive heart failure are not eligible.
Patients must not have uncontrolled infection.
AALL1732 Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
This phase III trial studies how well inotuzumab ozogamicin and post-induction chemotherapy work in treating patients with high-risk B-cell lymphoblastic lymphoma (B-ALL), mixed phenotype acute leukemia, and B-lymphoblastic lymphoma (B-LLy). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, cytarabine, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, thioguanine, vincristine, and pegaspargase, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The goal of the part 1 of the study is to collect information about leukemia and the effects of the first two phases of treatment, called Induction and Consolidation on this cancer. Additionally, this study aims to investigate whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for 3 years from the start of Interim Maintenance in patient with High Risk Favorable (HR-Fav) and HR B-ALL. Another aim is to understand the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) receiving HR B-ALL therapy. Finally, another goal of this study is to determine the outcomes of subjects with Mixed Phenotype Acute Leukemia (MPAL) with a favorable early response to treatment using High Risk B-cell Acute Lymphoblastic Leukemia therapy.
Consent to treatment, required labs, sample collections, and imaging.
B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to Eligibility studies (Part A) prior to treatment and enrollment on AALL1732.
White Blood Cell Count (WBC) Criteria
Patient has newly diagnosed B-ALL or MPAL (by WHO2016 criteria) with ≥25% blasts on a bone marrow (BM) aspirate
A complete blood count (CBC) documenting the presence of at least 1,000/µL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed
Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
Patients with Acute Undifferentiated Leukemia (AUL) are not eligible
Patients requiring radiation at diagnosis.
AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)
This partially randomized phase II/III trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.
Consent to treatment, required labs, sample collections, and completion of research study tests.
Patients in Group F must have a BSA ≥ 0.6 m2 .
Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
Patients newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma
Patients who are currently receiving another investigational drug
Patients who are currently receiving other anticancer agents
Patients with uncontrolled infection.
Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma.
AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplaitin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Standard Risk 1 Patients must be < 11 years of age at enrollmen
Standard Risk 2 Patients must be ≥ 11 and < 25 years of age at enrollment
Patients enrolling on one of the Low Risk arms must be newly diagnosed with a Stage I germ cell tumor. For the Standard Risk arms, patients must be newly diagnosed with metastatic germ cell tumor (Stage II or higher).
Patients must have a performance status corresponding to ECOG scores of 0, 1, 2 or 3. Use Karnofsky for patients > 16 years of age and Lansky for patients 16 years of age
Pure dysgerminoma
Pure mature teratoma
ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma
This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. To determine the feasibility of adding cabozantinib S-malate (cabozantinib) to standard MAP (high dose methotrexate, doxorubicin hydrochloride [doxorubicin], and cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a resectable primary tumor.
Consent to treatment, required labs, sample collections, and imaging.
Patients must be ≤ 21 years at the time of enrollment
Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable).
Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy
Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment
Patients unable to undergo radiation therapy, if necessary, as specified in the protocol
Evidence of uncontrolled infection
The Ethics of the Influence of Beauty-Focused Social Media Content on Cosmetic Procedure Intentions and Utilization Among Women Aged 21-25
This mixed-methods study examines the relationship between engagement with beauty-focused social media content created by young female influencers and intentions to pursue cosmetic procedures among women aged 21-25. The research employs both quantitative survey methods and qualitative interviews to understand this relationship and its ethical implications.
1 online survey (5-10 min) Some participants may be asked to partake in a 15 min qualitative interview
social media use of at least 3 hrs/week
ability to provide informed consent
under 21
diagnosed body dysmorphia
PSCI #25-020 NRG-CC013: A Randomized, Masked, Placebo Controlled, Phase II Trial of Concurrent Chemoradiation with BMX-001 in Patients with Head and Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation
This trial will examine the usual symptom management chemoradiation with or without BMX-001.
Participants must agree to come to all study visits. Participants will be coming to the clinic at least twice a month for treatment. After treatment is finished, you will be followed every three months to see how you are doing
Zubrod Performance Status of 0-2
Patients must have adequate health that permits completion of the study
Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy.
Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
Age < 18
prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer
current treatment of adjuvant post-op chemoradiation
Effects of substitutionary somatosensory haptic feedback on the control of myoelectrically driven virtual joint.
This study will examine the impact of natural and artificial feedback about joint position in a prosthetic driven by muscle activity.
Participants will be asked to come to the lab and contract their upper arm muscles in order to control the movement of a motor driving a virtual prosthetic to reach a set of targets either with feedback about their joint angle or without feedback.
15 dollars
healthy and able-bodied
right-handed
english speaking
2. All vulnerable populations are excluded from participating
A Multi-Site, Parallel-Group, Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) with Attention Control for the Reduction of Body Image-Related Distress Among Head and Neck Cancer Survivors
In this multi-site, parallel-group, randomized clinical trial, we will evaluate the efficacy of BRIGHT, a novel psychological intervention for cancer survivors, compared with attention control (AC) for managing body image distress (BID) among head and neck cancer survivors (HNC) survivors, examine BRIGHT’s underlying mechanisms, and characterize factors affecting the future adoption of BRIGHT into clinical care.
1. The researchers will check your medical records to gather information about your diagnosis and treatment. 2. You will meet with the study coordinator to fill out baseline questionnaires. 3. You will be randomly assigned to one of two groups. This means that you have a 50/50 chance (like flipping a coin) of being in either group. Neither the researchers nor you will make the choice to which group you are assigned. 4. Cognitive behavioral therapy involves meeting with a study psychologist to identify and address unhelpful automatic thoughts that may contribute to unwanted behaviors. The cognitive behavioral therapy group will meet with one-on-one with the study psychologist once per week for six weeks, using a video telemedicine platform. Each visit with the psychologist will take one hour. An attention control group is one that receives the same amount of attention as the intervention group but without the potential active ingredient. The attention control group will meet with one-on-one with a head and neck cancer clinician once per week for six weeks, using a video telemedicine platform to receive survivorship education. Each visit with will take one hour. These sessions will be video-recorded to help ensure that the interventionist delivers each intervention as intended. 5. Regardless of whether you are in the cognitive behavioral therapy or attention control group, you will meet with the study coordinator at the end of the study to complete questionnaires to measure changes compared to baseline and describe your experience in the study.
125
Completion of cancer treatment within 12 months of study enrollment
Cancer-free at time of accrual
No planned significant head and neck surgery
Willingness to complete 6 weekly educational or therapeutic sessions
Currently receiving ongoing psychotherapy services
Initiation or adjustment of psychotropic medications within the last 3 months
Mental illness diagnosis that would prevent trial participation
First-Generation Undergraduate Women in Engineering Majors: Pathways to Doctoral Study in STEM
This qualitative case study will explore the experiences of 10-15 First-Generation Undergraduate Women (FGUW) in engineering majors at PSU that led them to apply to STEM PhD programs, and also how they overcame any barriers they encountered to then still apply. The method for data collection will include 1-2 individual semi-structured participant interviews, as well as 1-2 focus group interviews with the full participant group. During the interview process, opportunities for artifact analysis or direct observation may arise. With the permission and agreement of the participant, if these opportunities arise, I will plan to do no more than one direct observation or artifact analysis per participant.
1-2 Individual Zoom Interviews, lasting about 1 hour each. 1-2 Focus Group Interviews, lasting about 1 hour each.
$30 Amazon Gift Card
Undergraduate Student at Penn State
Majoring in a College of Engineering Program Major
Intend to apply to a Science, Technology, Engineering, or Math PhD Program
A First-Generation College Student (no parent or guardian has obtained a 4-year college degree)
Male
AGCT1532 - A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors
Germ Cell Tumors (GCTs) are sorted in “risk groups” that describe how much the tumor has grown in the body. The three “risk groups” are: good, intermediate, and poor. For this study, we are interested in learning more about intermediate and poor-risk GCTs, also known as “advanced” GCTs. A research study is when doctors work together to try out new ways to help people who are sick. In this study, we are trying to learn more about how to treat GCTs. Standard treatment for advanced GCTs is chemotherapy (anti-cancer drugs). Some of the drugs used may cause bad effects that show up during treatment. This study will compare the standard way to treat GCTs with the same type of treatment, but delivered over a shorter amount of time (called “accelerated” treatment). This will help us understand if the accelerated treatment is better but not more harmful than the standard treatment. We will do this by closely watching to see if the cancer grows or spreads. We do not know which treatment will be better, which is why we are doing this study.
Consent to treatment, required labs, sample collections.
Histologically or cytologically confirmed germ cell tumor OR exceptionally raised tumor markers without histologic or cytologic confirmation
Primary arising in testis, ovary, retro-peritoneum, or mediastinum
Metastatic disease or non-testicular primary.
Significant co-morbid respiratory disease that contraindicates the use of bleomycin.
Peripheral neuropathy ≥ Grade 2 or clinically significant sensorineural hearing loss or tinnitus
Known allergy or hypersensitivity to any of the study drugs.
Online Cycling Program for People with Chronic Post-Stroke Aphasia
The purpose of this study is to see if an online cycling group for people with aphasia is a feasible way to get people with aphasia to exercise more.
There will be 24 30-minute exercise sessions spread out over 8 weeks (3x per week). Before and after, there will be physical, mental, and cognitive assessments.
at least 6 months since stroke
speak English
internet access
can see and hear
other neurological condition (e.g., Parkinson's)
taking medication that interferes with exercise
psychiatric illness
already physically active
EA5221: A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable older adult with Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study
This study is being done to answer the following question: Does adding chemotherapy to immunotherapy versus immunotherapy alone help older patients with lung cancer live longer while also maintaining a good quality of life? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your lung cancer. The usual approach is defined as care most people get for lung cancer.
If the participant decide to take part in this study, they will either get pembrolizumab alone until disease progression, or chemotherapy from study-provided list of allowable choices combined with pembrolizumab for up to 2 years or until disease progression. After the participant finishes study treatment, the study doctor will continue to follow their condition for 5 years from the date of registration for survival. The participant will be followed every 3 months < 2 years from registration, and every 6 months for years 2-5.
Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-RT for stage III with recurrence is allowed.
Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors.
Patient must have an ECOG Performance Status of 2.
Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment.
Neurocognitive Dynamics of Perimenopause: Patterns, Predictors and Mechanisms of Healthy Aging
The purpose of this study is to examine cognitive function during perimenopause and explore how these changes may be related to sex hormone levels and other psychological effects. The present study aims to address this gap by examining associations between estrogen and progesterone, as well as fluctuations in these hormone levels, in relation to cognition, measured comprehensively across self-report, behavioral measures, and neural assessments. By examining hormonal effects on cognition, the proposed study aims to inform strategies for early detection of cognitive vulnerability, promote resilience, and ultimately improve cognitive health outcomes for women across the lifespan.
Participants will be required to attend two in-person visits at our lab in Hershey, PA. At the first in-person visit, participants will complete three behavioral tasks and two computer tasks while EEG data is recorded. Participants will also complete questionnaires and give a saliva sample. Additionally, for four-weeks after this visit, participants will complete remote cognitive games and surveys via a link sent through text message and will collect saliva samples at home three times a week during this time. After four-weeks, participants will return for their second in-person visit where they will repeat the three behavioral tasks, a few questionnaires, and give another saliva sample.
$200
Fluent in English
Have had at least one menstrual period in the past 3 months
Have an intact uterus and at least one ovary
Have access to a smartphone
Not fluent in English
Women experiencing amenorrhea
Women who have had a hysterectomy
Comparative Effectiveness of Brief Strength and Balance Exercises and Standard Home-Based Group Exercise for Primary Care Patients with Mobility Disability Eficacia comparativa de ejercicios cortos de fuerza y equilibrio y ejercicios grupales estándar en casa para pacientes de atención primaria con discapacidad de la movilidad.
Comparing a brief, daily exercise program to a standard, group exercise program in treating older adults with walking difficulty. Comparación de un programa de ejercicios breves y diarios con un programa de ejercicios grupales estándar para pacientes de atención primaria con discapacidad de la movilidad.
There will be 3 in-person visits (~1 hour each) at Penn State Hershey Medical Center. You will wear a physical activity monitor 3 times. You will complete surveys at your convenience at home, online. You will meet with an exercise coach virtually via Microsoft Teams. Habrá 3 visitas presenciales (de aproximadamente 1 hora cada una) en el Centro Médico Penn State Hershey. Usará un monitor de actividad física 3 veces. Completará encuestas en línea cuando le resulte conveniente desde casa. Se reunirá virtualmente con un entrenador físico a través de Microsoft Teams. Compensación total: $110
110
Serious difficulty walking or climbing stairs
Internet access
Computer, tablet, or smart phone with a camera
Able to walk at least 10 feet
Planning to have surgery in the next 12 months
Participating in another research project involving physical activity, falls or weight loss
AOST2032: A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. In Part 1 of the study, we will find out the highest dose of cabozantinib that can be given in combination with MAP without causing side effects that are too severe. In Part 2, subjects will either receive a combination treatment of MAP with cabozantinib or MAP alone
At the start of the study and during treatment, patients will have blood drawn to check the levels of hormones from their thyroid and proteins that are made by the pancreas. Patients will also have the protein levels checked in their urine. The protein levels in the urine will be checked. In addition, patients' blood pressure will be monitored more often than usual because they are taking cabozantinib on this study.
Patients must have a body surface area of > 0.8 m 2 at the time of enrollment
Patients must have histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma
Patients who have central nervous system metastases.
Patients with central cavitating pulmonary lesions invading or encasing any major blood vessels in the lung.
Patients who are unable to swallow tablets. Tablets cannot be crushed or chewed.
A wearable transcutaneous CO2 sensor for detection of hypercapnia in ALS
Amyotrophic lateral sclerosis (ALS) progresses to chronic hypercapnic (excessive carbon dioxide) respiratory failure due to chronic hypoventilation. Transcutaneous carbon dioxide (tCO2) monitoring has the potential to advance home care needs in ALS if the size, complexity, and cost of the sensor can be reduced. The aim of this study is to perform clinical validation of a novel tCO2 sensor in the setting of ALS monitoring. Simultaneous measurements of tCO2 will be performed in ALS clinic using the prototype device alongside a commercial device and standard clinical metrics of respiratory function. A group of control participants will also be recruited. Participants will be queried on technology acceptance related to commercial and experimental devices. The clinical study is designed to test 1) the concurrent validity of the prototype wearable against commercial standard and 2) user opinion about the acceptance of this technology as a device for health monitoring.
The study involves a single visit lasting 1.5 hours. You will undergo two 15-minute recordings of CO2 from sensors placed on the skin. These will occur approximately one hour apart. You will then be asked about your experiences during the recordings in a brief interview.
$20
[Patients only] Diagnosis of ALS based on Gold Coast Criteria
[Healthy controls only] Age and sex matched to the patient cohort
[Healthy controls only] Neurologically healthy
Use of a tracheostomy
Use of diaphragm pacer
Use of supplemental oxygen for any portion of the day or night
Other neurological or psychiatric illness
SIBERATE-1: A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE
This study will evaluate the safety and efficacy of a novel drug R07790121 compared to placebo in Crohn's disease patients. This drug is an antibody which binds to TL1A, a known important molecule in the regulation of Crohn's disease pathways. The patients who agree to participate and sign the informed consent, will receive a drug or placebo by intravenous infusion on days 0, 2, 6, and 10 of the Induction phase of treatment. During the Maintenance phase of treatment, weeks 12-52, the patients will be randomized to two doses of the drug or placebo that will be given by subcutaneous injection every four weeks. In the Open label phase of treatment, patients will receive the drug every two or every four weeks. All participants will have in-person clinic visits, will be asked to complete daily study questionnaires, provide specimens (stool, blood, urine), and have procedure done (endoscopy, ECG, blood work).
There are two screening visits to find out if subject is eligible to participate. The informed consent must be signed at the first visit, before any procedures. The subjects will be randomized for an induction treatment in two drug arms and one placebo (1:3). The Induction treatment will take 12 weeks and include five visits to the site. They may continue treatment into the Maintenance phase, weeks 12-52, There are ten visits, every four weeks. If disease returns or worsens, the subject may start the open label treatment during the maintenance. Each visit will have blood draws done, vitals check, and some have physical exam.
$75 per completed visit and $50 for travel. Total will depend on the number of visits completed
Moderately to severe active CD (Crohn's disease)
Involvement of ileum an/or colon, with at least 4 segments or 3 segments if after bowel sugery
Agrees to use contraception, if Women Of Child Birth Potential must not be pregnant
Prior therapy failure
short bowel syndrome
presence of ileostomy, colostomy, or ileal-anal pouch
current diagnosis of Ulcerative colitis (UC)
presence of abscess
PSCI 25-051 NRG-GU014: Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC TRIAL)
This study will look to see if radiation plus immunotherapy is better than radiation and chemotherapy.
The participant will either get chemotherapy and radiation therapy for up to 4-7 weeks, or they will get radiation therapy for 4-7 weeks plus the immunotherapy drug, pembrolizumab, given every 6 weeks for about one year (for a total of 9 doses). After the participant finishes the study treatment the study doctor will continue to follow their condition for almost 10 years, either by telephone or clinic visit, and watch them for side effects. The study doctor will monitor the participant every 3 months for 2 years, then every 6 months for 3 years and then annually for 5 years.
Age ≥ 18
Not Pregnant and Not Nursing
Patients must have recovered from acute cardiac illness
No glucocorticoids
Neural and Sensorimotor Mechanisms of Visuomotor Actions: Linking Brain Activity, Muscle Coordination, and Visual Attention
This study explores how the brain, eyes, and muscles work together when people use their hands to track or catch moving objects. Participants will sit and use their right hand on a tablet to follow a moving virtual ball while wearing non-invasive sensors that record brain waves (EEG), muscle activity (EMG), and eye movements. The goal is to understand how the body prepares for and responds to motion using vision and movement control. The findings may help scientists improve therapies and technologies for people with movement difficulties, such as after a stroke or brain injury.
Participants will attend one in-person session lasting approximately 2 hours. During the session, they will wear an EEG cap, EMG sensors, and an eye tracker while completing a hand-tracking task using their right hand on a tablet.
20
Right-handed
Normal or corrected-to-normal vision
No history of neurological, psychiatric, or motor disorders
Able to sit comfortably for up to 2 hours
Presence of metal implants in the head (excluding dental fillings)
Skin sensitivity or allergies to adhesives or EEG gel
Use of medications that affect the nervous system
Parent Regulation, Engagement, Stress, and Health
The proposed research is designed to provide a stronger scientific understanding of the etiology of harsh discipline and the role of parent and child individual and dyadic regulatory processes as potentially malleable mechanisms that underlie and maintain harsh discipline use. The study involves observations of parents and children in the lab and parent questionnaires over multiple time points.
Participation includes two office visits and one online survey, spread out over two years. The first visit occurs when children are 2-3 years old and then again at 4 years old. At these office visits, parents and children complete tasks and play games together, and parents fill out surveys. We will ask you and your child to wear electrode stickers that attach to the skin to measure heart rate and breathing. We will also ask to collect a small hair sample and a few saliva samples from both you and your child throughout the visit. The office visits take approximately 3 hours each. Later, when children turn 5 years old, parents receive an emailed link to a set of online surveys that can be completed at home. It typically takes about 60 minutes to complete the surveys.
$430
Ability to communicate with child in English
Access to Wi-Fi and a laptop at home
Parent diagnosed with a cognitive, sensory, or motor disability
Child or parent taking medication that gives them an irregular heart rate or irregular breathing
PSCI# 25-079 NRG-CC015: Harnessing E-Mindfulness Approaches For Living-After Breast Cancer---HEAL-ABC
This study is comparing 3 arms, one in which patients will participate in Mindfulness (MAPs) Live Online. One in which patients will participate in Mindfulness (MAPs) digitally and one in which patients will participate in the control group, which is meditation only.
Screening visit will be in person. Patients will complete up to 3 hours per week of the assigned activity over a 6-week period. Participation in this study will last about 9 months.
The participant must have been ≥ 18 or <51 years of age at the time of breast cancer diagnosis.
The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
The participant must have a score of ≥ 5 and ≤ 14 on the Patient Health Questionnaire-8 item (PHQ-8).
The participant must be able to understand, speak, read, and write in English or Spanish.
Any history or current evidence of recurrent or metastatic breast cancer.
Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
Currently pregnant or planning to become pregnant in the near future.
Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.
Moments that matter: Mapping the temporal dynamics within human autonomous agent teams
The purpose of this study is to better understand how human teams with non-human virtual agent team members operate and function.
If you agree to be in this study, you will be fitted to sensors that will measure your neurophysiological (i.e., brain and cardiac) signals while you complete group tasks in person or in virtual reality. This interaction will be recorded and coded. You will also be asked to complete several questionnaires about your demographics, behaviors, and emotions.
$25-$40
English speaking
Willing/able to travel to Penn State University Park location research site
No cardiovascular, metabolic, or neurological condition
Willing to wear EEG sensors
Report or diagnosis of a neurological injury or disorders related to cardiovascular-respiratory, metabolic or brain function
Cannot speak or read English
Not willing to wear EKG sensors
Not willing to wear EEG sensors
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH NON-CIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH)/METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH) AND FIBROSIS
This is Phase III study to test whether efruxifermin (EFX) helps people with a liver disease called NASH/MASH who have moderate or advanced liver fibrosis. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with MASH and liver fibrosis over a long-term treatment. To answer these questions, the study drug will be compared with a placebo. The overall study duration will be up to 5 years.
Your participation in the study will last about 4 years and 11 months which includes 3 months for screening procedures (to understand if you are eligible to participate in the study), 4 years and 7 months of study drug treatment and a 30-day follow up at the end of the study. This will involve up to 38 visits to your Study Doctor. During the study, you will be asked to inject a short needle into the soft tissue under the skin (subcutaneous) in the stomach or upper thigh once a week.
Up to $4,320 over the study duration (about 4 years 11 months)
Diagnosis of NASH/MASH
Previous history or presence of Type II Diabetes
Body mass index (BMI) Greater than on equal to 25.0 kg/m2
Type 1 diabetes
Under the age of 18 or over the age of 80
Using Art Therapy to Teach Coping Skills to Adults with Autism Spectrum Disorder
This is a study that will examine the effectiveness of using Art Therapy techniques for improvement and maintenance of self-reported coping skills and symptoms co-occurring with Autism.
The study will last approximately 18 weeks. Participants will be randomly assigned to one of three groups. The assessment only group participants will spend approximately 30 minutes completing online assessments weekly. Participants assigned to the psychoeducational group will meet weekly in person for approximately 45 minutes. Participants assigned to the full art therapy intervention group will meet weekly in person for approximately 1.5 hours. Participants will be asked to complete follow-up assessments at 1 and 3-months after the last week of the assigned group.
English as a primary language spoken.
A primary diagnosis of ASD, as indicated by the SRS-2.
A minimum verbal IQ of 80 (determined by the administration of the K-BIT 2)
Ability to self-report (i.e., understand and answer questions at an appropriate comprehension level; self-report questions to be asked by study coordinator
Inability to provide consent.
Safety concerns (i.e. psychiatric higher level of treatment such as inpatient hospitalization, intensive Outpatient Programs, or partial hospitalization) within the past 3 months
A Long-term, Open-label Study to Evaluate the Safety and Efficacy of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema
The purpose of this clinical research study is to learn more about the use of the investigational drug, deucrictibant, for the prevention of HAE attacks and safety in patients when used in long-term treatment. Investigational drug means that it has not yet been approved in any country for the treatment of HAE. Deucrictibant tablets are designed to block the effects of bradykinin and thus prevent HAE attacks from starting. You will receive deucrictibant tablets for 130 weeks. All participants in the study will receive one 40mg deucrictibant tablet every day. From now onwards, deucrictibant will be referred to as “study drug”. The study drug is a tablet that you will take by mouth. Every day you will have to take 1 tablet with a glass of water, at approximately the same time each day either without a meal or with a light meal. Your study doctor will provide you with detailed instructions on how and when to take the tablets.
There will be approximately 11 in person visits, and approximately 4 virtual visits. At the in person visits, blood will be drawn, EKGs performed, vital signs collected, and the study doctor will perform exams. You will need to complete a daily electronic diary, and take the study medication, an oral pill, daily.
Documented clinical history consistent with HAE (cutaneous or submucosal, nonpruritic swelling without accompanying urticaria)
C1 esterase inhibitor (C1INH) functional level <50% of the normal level must be shown by chromogenic assay performed by the central laboratory as part of the Screening procedures.
History of at least 1 attack in the last 3 consecutive months prior to Screening
Female participants of childbearing potential (or who become of childbearing potential during the study) must agree to the protocol specified pregnancy testing and to use an acceptable contraception method.
Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
History of epilepsy and/or other significant neurological diseases
History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse