All Clinical Trials

The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy. The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy. Read Less

This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors. Sleep disturbance ranks among the top concerns reported by breast cancer survivors and is associated with poor quality of life. Many breast cancer survivors also have decreased physical activity, which may also have a negative impact on sleep and quality of life. Cognitive behavioral therapy for insomnia (CBTi) and physical activity interventions have individually been reported to improve sleep and to have a positive impact on quality of life. Cecebot is a personalized short messaging service (SMS)-based behavioral intervention that combines CBTi and physical activity strategies that may improve sleep for breast cancer survivors. Read Less

This study explores the best dose of the combination treatment for subjects with advanced unresectable or metastatic basal-like subtype pancreatic adenocarcinoma. For that reason, the safety, efficacy, and tolerability, as well as preliminary estimates of anti-tumor effects of low-dose epidermal growth factor receptor EGFR inhibitors in combination with bi-weekly gemcitabine/nab-paclitaxel (GnP) will be examined in subjects with advanced basal-like pancreatic adenocarcinoma. The Purity Independent Subtyping of Tumors (PurIST) will determine the type of cancer either "basal type" or "classical". If cancer subtype-based first-line chemotherapy in combination with erlotinib will be safe and tolerable in subjects with advanced unresectable or metastatic pancreatic adenocarcinoma of the basal-like subtype as defined by PurIST, as well as provide a preliminary assessment of treatment response in basal-like subjects. This study will also follow a subset of subjects with classical subtypes that are treated per standard of care on oxaliplatin-based triplet chemotherapy. Read Less

Patients undergoing general anesthesia require mechanical ventilation (artificial delivery of air and oxygen to their lungs). It is well known that during mechanical ventilation, so-called atelectasis formation occurs. This is a condition characterized by partial or complete collapse of lung tissue that can result in a reduction in oxygen uptake through the lung. A known risk factor for atelectasis formation during mechanical ventilation is the utilization of high oxygen concentration, as the oxygen molecules are absorbed in the lung, which then can lead to collapse of the tissue. Despite the proven association, standard operating procedure at the end of anesthesia still requires utilization of 100% oxygen. Its justification is the goal to ensure sufficient oxygenation throughout the extubation phase. However, clinical observation doesn't show a lack of oxygenation in this phase, but the patient is still exposed to the risk of atelectasis formation. This study aims to investigate the hypothesis of whether the utilization of reduced inspiratory oxygen concentration before extubation (70% or 40% compared to 100%) reduces atelectasis formation. The study was originally planned to randomize 24 patients to either 70% or 100% inspiratory oxygen concentration at the end of anaesthesia. After completion of this first phase, the study was amended to enroll another 24 patients randomized to 40% or 100% inspiratory oxygen concentration at the end of anaesthesia. Of note, both concentrations are still higher than when breathing room air in, which has of 21% oxygen. During the intervention, parameters such as the oxygen content in the blood (oxygen saturation, SpO₂), heart rate, and blood pressure are recorded, and atelectasis formation is measured using a technique called electrical impedance tomography (EIT). EIT measurements are performed at designated time points during the procedure. Anesthesia care providers are asked to document procedural, patient, and ventilator data in a questionnaire. Secondary outcomes are the homogeneity and distribution of air measured with EIT, as well as some clinical outcomes including post-extubation desaturation (\<90% SpO₂), incidence of re-intubation or non-invasive ventilation, and the Post-anesthesia Care Unit (PACU) length of stay. Read Less

This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study. Read Less

This project is a single center, prospective randomized controlled trial (N=198) primarily evaluating the efficacy of the Survivorship Sleep Program vs. Enhanced Usual Care on insomnia severity among cancer survivors. The investigators will also examine secondary outcomes associated with cancer-related insomnia including subjective and objective sleep measures (i.e., sleep diaries, actigraphy), emotional distress, fatigue, and use of sleep medications. Notably, most CBT-I trials with cancer survivors who have completed primary treatment with curative intent (i.e., curvivors) but not those in treatment or living with metastatic cancer (i.e., metavivors). To enhance generalizability, this RCT will stratify enrollment by survivorship phase (1:1:1). This project in strengthened by partnerships with community organizations (SurvivorJourneys and Ellie Fund) and use of both quantitative (i.e., surveys, actigraphy) and qualitative methods (i.e., interviews) to inform considerations for future implementation. Collectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, namely an efficacious, virtually delivered intervention addressing chronic insomnia, one of the most deleterious concerns among the growing population of cancer survivors in the US. Findings will inform a future effectiveness trial and the expansion of the synchronous delivery of CBT-I to survivors across different phases of cancer survivorship. Read Less

The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous (SC) ABBV-701 in healthy adult western and Asian participants. Read Less

This trial aims to evaluate the effectiveness of a multi-level, multi-component de-implementation strategy to reduce unnecessary preoperative testing. Sixteen Michigan Value Collaborative (MVC)/Michigan Surgical Quality Collaborative (MSQC) sites in Michigan will implement several tools that have been proven to reduce unnecessary testing at a single site, including clinician education, a decision aid, audit and feedback on performance, and a pay-for-performance incentive. The researchers believe that, through the use of these strategies, there will be a significant reduction in unnecessary preoperative testing during the intervention. Read Less

The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure. Read Less

This study is testing a non invasive way to measure airway pH in individuals with Asthma and Cystic Fibrosis using a new inhaled drug. The airway pH will help health care providers in creating tailored treatment plans for individuals suffering from these specific conditions. Read Less

Background: During a transplant, blood stem cells from one person are given to someone else. The cells grow into the different cells that make up the immune system. This can cure people with certain immunodeficiencies. But transplant has many risks and complications. Objective: To see if stem cell transplant can be successfully performed in people with primary immunodeficiency disease and cure them. Eligibility: People ages 4-69 for whom a primary immunodeficiency (PID) or Primary Immune Regulatory Disorder (PIRD), has caused significant health problems and either standard management has not worked or there are no standard management options, along with their donors Design: Donors will be screened under protocol 01-C-0129. They will donate blood or bone marrow. Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests CT or PET scans Before transplant, participants will have dental and eye exams. They will have a bone marrow biopsy. For this, a needle will be inserted through the skin into the pelvis to remove marrow. Participants will be hospitalized before their transplant. They will have a central catheter put into a vein in their chest or neck. They will get medications through the catheter to prevent complications. Participants will get stem cells through the catheter. They will stay in the hospital for at least 4 weeks. They will give blood, urine, bone marrow, and stool samples. They may need blood transfusions. They may need more scans. They will take more medications. Participants will have visits on days 30, 60, 100, 180, and 360, and 24 months after the transplant. Then they will have visits once a year for about 5 years Read Less

This phase I/Ia trial finds the best dose and side effects of venetoclax given in combination with ixazomib citrate and dexamethasone in treating patients with light chain amyloidosis that has come back (relapsed) or does not respond to treatment (refractory) and who have an abnormal genetic change \[translocation t(11;14)\]. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ixazomib citrate is in a class of medications called proteasome inhibitors. It works by helping to kill cancer cells. Anti-inflammatory drugs such as dexamethasone reduce inflammation by lowering the body's immune response and are used with other drugs in the treatment of some types of cancer. Combination therapy with venetoclax, ixazomib citrate and dexamethasone may be effective in treatment of relapsed or refractory light chain amyloidosis. Read Less