Village of Clarkston

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

Researchers are evaluating the effectiveness and safety of baricitinib for treating severe or very severe alopecia areata, a form of hair loss, in children aged 6 to less than 18 years. This Phase 3 clinical trial aims to better understand how baricitinib works in this young population with this condition. The study is sponsored by Eli Lilly and Company and focuses on pediatric patients with a history of severe alopecia areata. Participants are randomly assigned to receive either a high dose or low dose of baricitinib taken orally, or a placebo. The study is divided into four periods a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive the assigned study medication, an approximately 2-year long-term extension period for ongoing treatment, and a 4-week post-treatment follow-up. Some participants may continue treatment for up to a total of 180 weeks if eligible after the extension period. Throughout the study, participants undergo regular assessments including measurement of hair loss severity using the Severity of Alopecia Tool SALT score, patient-reported outcomes related to scalp hair and eyebroweyelash hair loss, and quality of life questionnaires. Safety and pharmacokinetics of baricitinib are also monitored. The primary outcome is to measure the percentage of participants achieving a SALT score of 20 or less by week 36. Participants receive careful monitoring during and after treatment, with the total study duration extending over multiple years.

Researchers are investigating whether adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy using the TheraBionic P1 device can affect the pathological response in patients with resectable early-stage breast cancer. This study focuses on women with hormone receptor-positive, HER2-negative breast cancer who are planning upfront surgery. The research is designed to evaluate the treatments impact before surgery in a neoadjuvant setting. Participants will self-administer the TheraBionic P1 device therapy three times a day for 60 minutes each sessionmorning, midday, and eveningover approximately two weeks before their scheduled tumor resection surgery. This device delivers amplitude-modulated electromagnetic fields continuously during these sessions. The study does not include a comparison group or blinding. During the trial, participants will have their tumor tissue evaluated for pathological response at the time of surgery. Researchers will also analyze changes in microRNA, Ki-67, tumor apoptosis marker Cleaved caspase-3, and cell cycle arrest marker p27 from baseline to post-surgical tissue. Long-term follow-up will assess overall survival and progression-free survival for up to five years after surgery. Participants will be monitored for safety and treatment adherence throughout the study period.

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Researchers are evaluating the effectiveness and safety of Corabotase IPN10200 in adults with moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows that may affect appearance and confidence. This Phase III study compares a single dose of Corabotase to a placebo in a double-blind phase, followed by an open-label phase to assess repeat doses over time. Participants will receive injections of Corabotase or placebo into selected facial muscles. The study includes a screening period of up to 20 days, a treatment period with up to four treatment cycles where participants may receive Corabotase or placebo in the double-blind phase and Corabotase in the open-label phase, and a follow-up period lasting 24 weeks after the last injection. Multiple visits occur during the first month of treatment, followed by monthly visits. During the study, participants will have health assessments including blood tests, physical exams, ECGs, questionnaires, and diaries. Researchers will measure treatment response at week 4 and monitor safety and satisfaction through week 104. Total participation lasts up to 107 weeks, and participants may withdraw at any time.

Alopecia areata AA is a condition where the immune system attacks hair follicles, causing hair loss mainly on the head and face but possibly on other body parts. This research evaluates the safety, effectiveness, and tolerance of upadacitinib, an approved drug, in adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled, double-blind trial enrolling about 1500 participants worldwide. Participants are randomly assigned to one of three groups receiving different treatments two doses of upadacitinib or placebo. In initial periods, some may switch from placebo to upadacitinib based on their Severity of Alopecia Tool SALT score. Those completing early parts may enter an extension phase receiving upadacitinib for up to 108 weeks. Treatment involves taking oral tablets once daily for up to 160 weeks, with possible re-randomization at Weeks 24 and 52. Throughout the study, participants attend regular clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires to track treatment effects. Researchers measure hair loss improvement using SALT scores and record adverse events over approximately 164 weeks. Participants are followed for up to 30 days after their last dose for safety monitoring.

Researchers are evaluating the safety and effects of two study medicines, PF-07275315 and PF-07264660, for treating moderate to severe atopic dermatitis AD, a long-lasting itchy red rash caused by a skin reaction. The study includes adults aged 18 years or older who have had AD confirmed for at least six months and have not responded effectively to topical treatments. The study is a Phase 2 randomized, double-blind, placebo-controlled trial sponsored by Pfizer. The study consists of multiple stages. In Stage 1, participants received PF-07275315, PF-07264660, or a placebo for 12 weeks. Stage 2 involves PF-07275315 or placebo injections over 12 weeks. Stage 3 includes participants who previously received anti-inflammatory proteins, with treatment lasting up to 32 weeks. Stage 4 involves PF-07264660 or placebo injections for 12 weeks. All injections are given as multiple shots in a clinic setting. Participants will be in the study for up to 40 weeks in Stages 1, 2, and 4, and up to 52 weeks in Stage 3. Researchers will monitor skin improvements using measures such as the EASI75 score, which reflects a 75% improvement in eczema severity, along with other skin assessments, vital signs, ECG, and laboratory tests. Safety and treatment effects will be closely observed throughout the study period.

Researchers are evaluating the combination of amplitude-modulated radiofrequency electromagnetic fields AM RF EMF and Fruquintinib in adults with metastatic colorectal adenocarcinoma that has not responded to standard treatments. This Phase 2 study aims to determine if adding AM RF EMF to Fruquintinib improves survival while being safe and tolerable. The trial focuses on patients whose cancer has progressed despite previous therapies targeting RAS, BRAF, MSIMMR, and HER2 markers. Participants receive treatment with the TheraBionic P1 device delivering AM RF EMF three times daily continuously, alongside daily doses of Fruquintinib taken orally in cycles of three weeks on treatment followed by one week off. This combined therapy is studied throughout the treatment period, with careful monitoring of safety and tolerability. Throughout the study, participants undergo regular assessments including imaging scans CT, MRI, or PET to evaluate disease status, and blood tests to measure biomarkers like carcinoembryonic antigen CEA and microRNA levels. Researchers will track overall survival up to five years post-treatment or until death. Safety is monitored during treatment and for 28 days after device discontinuation. The total participation duration varies as outcomes are followed long term.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

Researchers are evaluating the Ask Questions about Clinical Trials ASQ-CT brochure, a communication tool designed to improve conversations between patients and healthcare providers about clinical trials. This trial focuses on patient-provider communication and provider invitations to clinical trials among adults with oncology, cardiac disease, or neurologic disorders who are potentially eligible for clinical trials. The study is conducted by the Barbara Ann Karmanos Cancer Institute and is a health services research trial. Participants receive the ASQ-CT brochure at the baseline visit Time 1 as the main intervention. They complete questionnaires at three timepoints baseline Time 1, before their research visit Time 2, and after their research visit Time 3. The brochure serves as a question prompt list aimed at facilitating communication about clinical trials. Throughout the study, participants answer surveys that measure their confidence in managing patient-provider interactions, knowledge about clinical trials, trust, and distress levels at different timepoints. The researchers also track how many participants engage with the brochure and how well the intervention is implemented over up to three months. The total participation duration spans from the initial baseline questionnaire to the post-research visit follow-up.