The goal of this clinical trial is to evaluate the safety and efficacy of 3 different dose levels of CLR 125 in patients with advanced triple negative breast cancer. The main questions the study aims to answer are:
* What dose and regimen should be used in future trials of CLR 125 in patients with advanced triple negative breast cancer.
* What side effects do participants have when taking CLR 125.
Participants will:
* Have CLR 125 administered via infusion 4 times each cycle; repeated every 8 weeks.
* Visit the clinic once every 3 weeks for checkups and testing.
* Report any side effects or new medications.
Some participants may also receive one dose of CLR 131 to evaluate the amount of radiation delivered to various organs and to the tumor. These participants will:
* Have 4 scans completed over 2 weeks
* Have blood drawn 6 times over 2 weeks.
Breast Cancer· Cellectar Biosciences, Inc.· Jacksonville, Florida · Glen Burnie, Maryland +2 more
This is a pilot trial to assess how measures of inflammation are correlated with Social Determinants of Health (SDoH) in breast cancer patients. Expected duration of subject participation is one single time point. The patients will fill out questionnaires and provide a plasma sample.
Breast Cancer· Thomas Jefferson University· Philadelphia, Pennsylvania
This clinical trial will assess the safety and early efficacy of Hydroxychloroquine or Avelumab, with or without Palbociclib, in early-stage ER+ breast cancer patients who are found to harbor disseminated tumor cells (DTCs) in the bone marrow after definitive surgery and standard adjuvant therapy.
Breast Cancer· Abramson Cancer Center at Penn Medicine· Washington D.C., District of Columbia · Chicago, Illinois +3 more
The purpose of the study is to learn more about ways to help patients understand and manage side-effects from hormone therapy. The investigators will use the information from this study to design future studies to better understand how our well our tools work to help patients monitor and manage symptoms from hormone therapy and to stay on their hormone therapy for the recommended period of time.
Cancer· Abramson Cancer Center at Penn Medicine· Philadelphia, Pennsylvania
This trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related Quality of Life (QoL) and occurrence of lymphedema two years after randomization.
Breast Cancer· University Hospital, Basel, Switzerland· Bethesda, Maryland · Durham, North Carolina +2 more
Many people living with metastatic breast cancer face challenging symptoms and frequent medical visits. At the same time, conversations about personal goals, values, and preferences for care may not always happen as early or as often as patients and families would like. This multi-site study will test the effectiveness of a five-session palliative care program, designed specifically for people with metastatic breast cancer and their caregivers, to strengthen communication with clinicians about what matters most in their care. The study aims to inform how palliative care services can be delivered in a more timely, personalized, and scalable way for people living with advanced cancers who have long disease trajectories, such as metastatic breast cancer.
Metastatic Breast Cancer· Massachusetts General Hospital· Boston, Massachusetts · Durham, North Carolina +1 more
While current AI technology is suitable for automating some repetitive clinical tasks, technical challenges remain in solving critical and gainful problems in the domains of patient and disease management. The proposed research seeks to address issues in medical AI, such as integrating medical knowledge effectively, making AI recommendations explainable to clinicians, and establishing safety guarantees.
Artifical Inteligence· Abramson Cancer Center at Penn Medicine· Philadelphia, Pennsylvania
The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.
The goal of this clinical trial is to study the safety, feasibility, histologic and immunological effects of Mitazalimab, a CD40 agonistic antibody, when administered either alone or in combination with PD-1 inhibition prior to surgical resection.
The investigator hypothesizes that preoperative administration of CD40 agonist with or without PD-1 inhibitor intratumorally will demonstrate an acceptable safety profile, will not result in an unplanned delay in surgery, and will lead to increased immune activation.
Subjects will receive a single intratumoral dose of CD40 agonist with or without PD-1 inhibitor 7 or more days prior to surgery and will be followed for safety, feasibility, immune, and pathologic responses.
Breast Cancer· Jennifer Zhang· Philadelphia, Pennsylvania
The goal of this study is to test bundled familial cancer risk assessment + multicancer (colorectal + breast) vs. single (breast) cancer navigation, using a wait list control for colorectal cancer screening referral and navigation. Among those eligible, this study will test usual care referral to genetic services vs. pretest education + usual care referral. The study also will assess how bundled multicancer navigation works and for whom it is most effective through a multisite, mixed-methods patient- and organization-level process evaluation.
Breast Cancer Screening· Georgetown University· Newark, Delaware · Washington D.C., District of Columbia· Ages 45–74
The primary objective is to determine the cross-sectional relationship between sleep duration (as measured by 14 days of actigraphy) and glycemic control in an adolescent Type 2 Diabetes (T2DM) cohort (age 12-20y, n=67). A secondary objective is to determine if a loss-framed incentive for achieving sleep goals can increase sleep duration in 15 adolescent patients diagnosed with T2DM with insufficient sleep. Another secondary objective is to test if increasing sleep duration leads to improved glycemic control in 15 adolescents with T2DM identified in Aim 1 as having \<8 hr sleep/evening. A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.
Type 2 Diabetes· Children's Hospital of Philadelphia· Philadelphia, Pennsylvania· Ages 12–20
Only 2% of Americans meet the recommended levels of whole grain consumption, despite its association with reduced risk of type 2 diabetes. This study aims to assess if consumers with prediabetes or type 2 diabetes can be encouraged to switch from buying refined grain products to whole grain products when shopping for groceries online. The study will use personalized marketing strategies, with or without discounts which adjust based on purchasing behavior, to promote whole grain consumption.
Type 2 Diabetes· University of Pennsylvania· Philadelphia, Pennsylvania· Ages 45–70
The goal of this clinical trial is to learn about the effect of the study drug (ZT-01) on low blood sugar (hypoglycemia) in adults with type 1 diabetes (T1D) who have been having low blood sugars ("hypos") at night. ZT-01 increases the amount of a hormone called glucagon during low blood sugar, and this may help prevent the occurrence of hypos. The main questions this trial aims to answer are whether ZT-01 lowers the number of hypos happening at night, and what its effects are on blood sugar levels. The safety of ZT-01 will also be measured.
Participants will be asked to wear a study-provided continuous glucose monitor (CGM) during two 4-week periods when they will self-inject the study drug before bed. They will get ZT-01 at one of three dose levels during one period, and placebo (which looks like the study drug but doesn't contain the active ingredient) during the other. Neither the participant nor the study site will know what they are receiving during each treatment period or see data from the CGM. The participant will continue to use their usual methods of measuring blood sugar (including their personal CGM) and giving insulin during the study. The participant will be asked to complete a short diary each evening, and will be asked to upload the CGM data to a study phone every day.
If a participant uses their own CGM and is willing to share information on how often they have low blood sugar with the study site at the first visit to see if they meet study entry requirements, they will have 6 study visits, 2 study phone calls, and be in the study for about 16 weeks. If they don't use CGM or don't want to share their information, then they will be asked to wear a study CGM for an extra 4 weeks to find out how many low blood sugars they have, and will have an extra visit.
Study participants will be asked to give blood and urine for testing to see whether they meet the requirements to enter the study, and at the start and end of each treatment period to see if the study treatment has any effects. They will also have their blood pressure and temperature taken at each study visit, and have an ECG at 4 visits to measure the electrical activity of their heart.
Some participants will be asked to also take part in a sub-study where their blood level of ZT-01 and glucagon is measured, after the first and last dose. They will be asked to stay at the study site overnight for each set of measurements (4 in total).
Type 1 Diabetes Mellitus With Hypoglycemia· Zucara Therapeutics Inc.· Birmingham, Alabama · Little Rock, Arkansas +3 more· Ages 18–75
This study is designed to determine the pharmacokinetic and pharmacodynamic response of dorzagliatin 50 mg twice daily following 7-day administration in individuals with pancreatic insufficient cystic fibrosis and abnormal glucose tolerance when compared to randomized, double-blind 7-day administration of placebo in a cross-over fashion. We hypothesize that dorzagliatin administration will result in significant drug concentrations and improved glucose tolerance, early-phase insulin secretion, glucagon suppression, and hepatic glycogen storage assessed during a standardized mixed-meal tolerance test.
Pancreatic Insufficiency· Michael R. Rickels, MD, MS· Philadelphia, Pennsylvania
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
The purpose of this study is to compare patient adherence to blood sugar monitoring during pregnancy using two different measurement methods in pregnancies complicated by pregestational type 2 diabetes (T2DM). Pregnant patients with T2DM are at risk of having larger babies, babies with low sugar levels in the first 24 hours of life, higher rates of cesarean delivery, stillbirth (death of baby inside the womb), and hypertensive or high blood pressure disorders of pregnancy, such as preeclampsia. Prior studies have shown that treating high blood sugars in pregnancy with medications can reduce these risks. To determine the amount of medication needed, recording of blood sugar levels is necessary. This trial aims to determine whether continuous blood sugar monitors have improved patient recording of blood sugar levels over finger stick blood sugar measurements.
Patients involved in the study will be assigned to either:
1. Fingerstick glucose monitoring (FSG)
2. Continuous glucose monitoring (CGM)
Patients will be randomize in a 1:1 ratio.
FSG Group: blood sugar is tested four times daily - once fasting and two hours after every meal (post-prandial). Blood will be tested using a glucometer, and values will be recorded in a blood sugar log from the time of enrollment to the time of delivery.
CGM Group: A CGM sensor will be placed on the patient's arm for blood sugar collection every 3-5 minutes. This data is sent to a phone application from the time of enrollment to the time of delivery. These sensors will need to be replaced every 14 days.
Percent adherence will be recorded from the time you were randomized to a study group until delivery.
Type 2 Diabetes Mellitus (T2DM)· Thomas Jefferson University· Sewell, New Jersey · Philadelphia, Pennsylvania
The goal of this observational study is to learn more about kidney health in adults with diabetic kidney disease and other groups. Researchers will study kidney tissue and other samples. They want to learn how sodium-glucose cotransporter-2 (SGLT2) inhibitors, a type of diabetes medicine, may affect the kidneys. People can join only if they are already having a kidney biopsy or kidney surgery as part of their regular medical care.
The main questions this study aims to answer are:
* Do people who take SGLT2 inhibitors show different biological patterns in kidney tissue than similar people who do not take them?
* Are these kidney tissue patterns linked with how kidney health changes over time?
Researchers will compare participants who take SGLT2 inhibitors with similar participants who do not take these medicines.
Participants will:
Let researchers use one stored slide of kidney tissue from their regular care (no extra research biopsy) Give a blood sample and a urine sample Let researchers review medical record information over time
Diabetic Nephropathies· University of Pennsylvania· Philadelphia, Pennsylvania
The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.
Diabetes Mellitus, Type 1· Eli Lilly and Company· Santa Barbara, California · Tallahassee, Florida +3 more· Ages 1–35
The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.
Gastroparesis· Johns Hopkins Bloomberg School of Public Health· Scottsdale, Arizona · Louisville, Kentucky +3 more· Ages 18–85
The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are:
(1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.
Gestational Diabetes Mellitus in Pregnancy· Jaeb Center for Health Research· Birmingham, Alabama · Miami, Florida +3 more