Albany

Researchers are evaluating a new medication called CX11 for adults with type 2 diabetes who have not achieved adequate blood sugar control despite taking a stable dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days. This phase 2 study is randomized, double-blind, and placebo-controlled, aiming to determine the safety and effectiveness of different doses of CX11 in comparison to placebo. Participants will be randomly assigned to one of six groups, each receiving a different dose of CX11 40 mg, 80 mg, 120 mg, 160 mg, or 200 mg or a matching placebo. The medication is taken orally once daily for 24 weeks, followed by a 2-week safety follow-up period. The study is conducted across multiple medical centers and neither participants nor staff will know the group assignments during the trial. Throughout the study, participants will undergo regular assessments including blood tests to measure changes in HbA1c a marker of blood sugar control, fasting plasma glucose, body weight, and blood pressure. Continuous glucose monitoring will track time spent in the target glucose range. Safety is monitored by recording adverse events and measuring plasma drug levels at specified intervals. The total participation period is approximately 26 weeks.

Researchers are evaluating ALTO-207 compared to a placebo in adults with treatment-resistant depression TRD to measure changes in depressive symptoms. This phase 2 trial aims to better understand the effects of ALTO-207 on depression severity in participants who have not responded well to previous antidepressant treatments. Participants will be randomly assigned to receive either ALTO-207 twice daily or a matching placebo. The study is double-blind and placebo-controlled, ensuring that neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 8 weeks, during which changes in depressive symptoms will be closely monitored. During the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS to track changes in depression severity from the start through 8 weeks. Additional evaluations include response rates and clinical global impressions of severity over time. Safety and symptom monitoring will occur throughout, and participation may last up to 8 weeks based on treatment and follow-up visits.

Researchers are studying the Caris Biorepository, a project designed to collect and store high-quality biological specimens and related clinical data to support research aimed at advancing precision medicine and improving patient care. This observational study focuses on gathering samples and information from various sources, including healthy individuals and cancer patients, to help understand disease treatments and clinical outcomes. The biorepository includes samples from different donor groups, such as those with no disease, treatment-nave patients with new solid tumors, individuals at higher risk for cancer, patients with advanced cancer, and those with a history of cancer but no active disease. The project aims to maintain molecular integrity and clinical relevance of these specimens while providing access to researchers and collaborators for drug development, clinical trials, and healthcare policy enhancements. Participants provide informed consent and contribute biological samples and clinical data that are securely stored and shared for research purposes. The study measures include ensuring specimen quality and relevance over 35 years and facilitating specimen release for testing. Laboratory testing will be conducted throughout the study duration. The project supports long-term research collaboration and aims to impact patient outcomes and treatment practices over time.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

The trial investigates treatments for younger patients with intermediate risk acute myeloid leukemia AML. It compares three therapy combinations cytarabine with daunorubicin, cytarabine with daunorubicin plus venetoclax, and venetoclax with azacitidine. This phase II study aims to evaluate whether adding venetoclax improves the elimination of leukemia cells compared to standard treatment, focusing on measurable residual disease MRD after remission. Participants are randomly assigned to one of three arms. Arm I receives daunorubicin intravenously on days 2-4, cytarabine intravenously on days 2-8, and venetoclax orally daily on days 1-11, with possible reinduction based on bone marrow assessment. Arm II receives azacitidine intravenously or subcutaneously on days 1-7 or 1-5 and 8-9, plus venetoclax orally daily on days 1-28 for two cycles. Arm III receives daunorubicin intravenously on days 1-3 and cytarabine intravenously on days 1-7, with possible reinduction depending on bone marrow results. Treatment continues unless disease progresses or side effects become unacceptable. During the trial, participants undergo bone marrow aspiration, blood sample collection, and heart function tests like echocardiography or MUGA scans. After treatment, follow-up visits occur at 4 weeks, then every 3 months for one year, every 6 months for the second year, and yearly afterward. Researchers assess outcomes such as undetectable MRD rates, remission rates, survival, relapse, and treatment side effects over several years.

Researchers are evaluating how different telephone-based symptom monitoring and counseling interventions affect symptom burden and psychological distress in people receiving oral anti-cancer treatments. This study compares interactive voice response IVR symptom monitoring alone versus IVR combined with an educational handbook and telephone interpersonal counseling TIPC to help reduce symptoms and emotional distress such as depression and anxiety. Managing these symptoms is important because they often cause treatment interruptions and unplanned health services use, which are common challenges in community oncology settings. Participants are assigned to one of two groups one group receives weekly IVR calls for 12 weeks to report symptoms, which are then sent to their healthcare provider the other group receives the same IVR calls plus a symptom management handbook. Those in the second group who report feeling anxious, discouraged, or sad for two consecutive weeks during the first month also receive up to 8 weeks of telephone counseling aimed at addressing psychological distress. Following the 12-week intervention, participants are monitored for an additional 5 weeks to assess sustained effects. During the study, participants will complete weekly symptom assessments via phone calls, and data on symptom severity, psychological distress, and health service use will be collected. Researchers will also evaluate the feasibility, acceptability, and cost of the interventions from the perspective of healthcare providers in community oncology practices. Follow-up assessments for practice personnel will occur at intake and at 12 and 25 months. The main outcomes focus on symptom severity through week 12 and unplanned health services through week 17.

Researchers are evaluating the effectiveness and safety of ribupatide KAI-9531 given as a once-weekly subcutaneous injection compared to semaglutide and placebo for people living with obesity who do not have diabetes. This Phase 3, randomized, partially-blinded study aims to show that ribupatide is superior in reducing body weight. Participants included have a body mass index BMI of 35 kgm or higher and a history of unsuccessful weight loss attempts through diet and exercise in the past 6 months. Participants will be randomly assigned to one of four groups two different doses of ribupatide once weekly, semaglutide once weekly, or a placebo injection once weekly. The study treatment is administered by subcutaneous injection, and the treatment period lasts for 76 weeks. The study compares the percentage change in body weight among these groups and also monitors several other health measures related to weight, metabolism, quality of life, and safety. During the study, participants will have regular visits for assessments including body weight, waist circumference, blood pressure, cholesterol levels, and questionnaires about eating behaviors and quality of life. Researchers will also monitor for any adverse events and test for antibodies against the study drugs throughout the 80-week period. The total participation duration may extend up to 80 weeks, including safety follow-up after the treatment period ends.

This research aims to understand how the Safe Dates for Young Parents SDYP program influences sexual and reproductive health behaviors, attitudes about healthy relationships, and intimate partner violence IPV prevention in adolescent and young adult females who are pregnant or parenting. Researchers want to see if the SDYP intervention changes these behaviors and beliefs compared to those who do not receive the program. Participants in the SDYP group will take part in ten 50-minute group sessions involving interactive discussions, role-plays, games, brainstorming, and creative activities like poster contests and theatrical plays. The control group will receive standard services such as case management and comprehensive sex education but without the IPV or healthy relationship content included in SDYP. Referrals to additional services will be available for all participants as needed. During the study, participants will complete interviews at three, six, and twelve months to assess sexual behaviors like condomless vaginal or anal sex, experiences of sexual and reproductive coercion, negotiation of contraception use, IPV occurrences, and attitudes toward healthy relationships. Researchers will monitor changes over time to evaluate the programs impact. The total participation lasts about one year, with ongoing contact information collection and verbal consent obtained for enrollment.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential effectiveness of the investigational drug ENV-294 in adults with moderate to severe asthma who are already using inhaled corticosteroids and long-acting beta2-agonists. This phase 2, randomized, double-blind, placebo-controlled study aims to better understand how ENV-294 works and how safe it is for this population. The study is sponsored by Enveda Therapeutics and involves adult participants aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least one year. Participants will be randomly assigned to receive either oral ENV-294 tablets or matching placebo tablets once daily for 12 weeks. Prior to starting treatment, there is a screening period of up to 28 days to confirm eligibility based on lung function, asthma control, and medical history. Those in the treatment arm will take ENV-294 under supervision, while those in the placebo arm will take a similar-looking tablet without active drug. All participants continue their background asthma treatment with inhaled corticosteroids and long-acting beta2-agonists. Throughout the study, participants will attend scheduled visits for monitoring safety, measuring drug levels in the blood, and evaluating asthma control and lung function. Assessments include tracking adverse events, lung function tests, asthma control questionnaires, and monitoring for asthma exacerbations. The primary outcome is the incidence and severity of adverse events from the first dose through approximately 16 weeks. Participants are observed closely to understand how ENV-294 affects asthma symptoms and overall health during and shortly after the 12-week treatment period.