Needham

This research aims to establish a Phase-2 master protocol framework to evaluate the safety and effectiveness of various investigational treatments for chronic weight management in adults with obesity or overweight. The study sets common entry criteria for participants across multiple specific intervention groups, called intervention-specific appendices (ISAs), which may begin independently as new treatments become available for clinical testing. The overall results will be reported after all ISAs are completed. The study involves multiple investigational drugs administered either by injection (subcutaneously) or orally. These include LY3305677, LY3841136, Tirzepatide, LY3549492, LY3532226, and placebo treatments matching the administration methods of the active drugs. Each ISA will detail the specific intervention procedures. Treatments are given according to the ISA schedules as participants are assigned to different groups. Participants will be involved from screening through treatment and monitoring phases, where their body weight stability and other health parameters are assessed. Researchers will track the number of participants allocated to each ISA during the first six weeks. Safety and efficacy will be evaluated throughout the study, which includes regular assessments and adherence monitoring. The study includes adults aged 18 to 75 with specific body mass index (BMI) criteria and weight stability prior to enrollment.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are exploring personalized nutrition by studying how individuals respond differently to various foods. This research builds on data from over 2,000 people and aims to improve machine learning models that predict these responses, helping to tailor dietary advice to each person. The study focuses on people enrolled in the commercial ZOE testing program and involves individuals with a range of health conditions, including diabetes, heart diseases, obesity, and metabolism-related issues. Participants will undergo a dietary intervention lasting from 6 to 14 days. On the first day, they will fit a continuous glucose monitor to track blood sugar levels. For up to six days, they will eat two standardized meals provided by the study, which include common foods from US supermarkets, and record any leftovers using a digital app. Outside these meals, participants can eat freely but must log all food, drinks, and lifestyle factors such as sleep and exercise through a specially designed app. The study team will maintain regular contact to support adherence. During the study, participants will provide information about their height, weight, and lifestyle via questionnaires. They will also collect blood samples and stool samples on specified days. The continuous glucose monitoring device records glucose every five minutes. Researchers will evaluate glucose, blood lipids, gut microbiome diversity, hunger, and appetite to understand post-meal responses. An additional follow-up study offers some participants dietary guidance over 4 weeks and tracks health outcomes up to 12 months, including weight, bowel habits, hunger, and energy levels.

Researchers are evaluating a type 1 hybrid effectiveness-implementation cluster randomized clinical trial involving shared decision making training for breast surgeons and a patient decision aid for women aged 70 and older diagnosed with low-risk Stage I breast cancer. This trial, conducted at seven large U.S. health systems, compares the intervention to usual care to understand its impact on treatment decisions and outcomes. The study focuses on women with small (2 cm or less), estrogen receptor positive, HER2-negative breast cancer and aims to improve communication and decision quality between patients and surgeons. The intervention group surgeons receive a one-hour training in shared decision making and access to decision support tools. Eligible patients receive a tailored patient decision aid by mail, email, or patient portal before their first surgical visit. Usual care surgeons continue their standard treatment discussions without additional decision support. The study includes baseline and follow-up surveys for surgeons and patients, with training offered to usual care surgeons after trial completion. Patient recruitment and decision aid distribution are carefully monitored throughout the study. Participants undergo medical record reviews to assess treatments received within six months of surgery and long-term outcomes up to 3.5 years. Patient and caregiver surveys at one week and six months after the initial visit measure shared decision making quality, treatment knowledge, decisional conflict, quality of life, and treatment satisfaction. The study also evaluates healthcare costs and conducts qualitative interviews with patients, caregivers, surgeons, and healthcare professionals to understand implementation and dissemination. The trial expects to enroll about 402 participants including surgeons, patients, caregivers, and allied health professionals.

Researchers are evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 trial focuses on participants with mild to moderate HS who have had the condition for at least six months. The study aims to see how well the cream works in reducing HS symptoms compared to a placebo cream (vehicle cream). Participants will be randomly assigned to apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily on affected areas. The study specifically includes those with a certain number of abscesses and nodules but no draining tunnels, affecting at least two different body areas. The study also requires participants to avoid using antibiotics or antiseptic products on affected areas during the vehicle-controlled period and part of an extension phase. During the study, researchers will monitor participants closely through assessments of the skin condition and safety checks. They will measure the proportion of participants who achieve a significant clinical response by week 16. The total body surface area treated must not exceed 20%, and participants will be followed to ensure adherence and safety throughout the trial period.

Researchers are evaluating the impact of Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) treatment, which uses customized scleral lenses to treat various ocular surface diseases, on mental health, especially mood disorders like depression. The study explores the connection between improvements in eye symptoms or vision and changes in mental health. Conditions targeted include dry eye diseases and ocular manifestations of systemic illnesses, which often cause severe pain and vision problems, potentially affecting patients' mood and daily functioning. PROSE treatment involves designing and fitting a customized rigid gas permeable scleral lens filled daily with preservative-free saline to protect and lubricate the eye, correct irregularities, and improve vision. Patients undergo a consultation for PROSE or scleral lenses and receive treatment aimed at reducing ocular surface pain and preventing vision loss. The study measures mental health effects through validated questionnaires, including PHQ-9 for depression symptoms, alongside ocular symptom assessments and quality of life evaluations. Participants will be assessed at enrollment, then 28 days and 84 days after receiving PROSE treatment, using the PHQ-9 questionnaire to track mood changes. Researchers will monitor ocular symptoms with the Ocular Surface Disease Index and quality of life with the Visual Function Questionnaire. The study requires participants to complete all procedures and follow instructions in English, with several safety and eligibility checks in place to ensure valid and safe participation.