182,585 Clinical Trials for Various Conditions
The study involves multiple retrospective analyses to understand the utilization of mental health treatments provided at Greenbrook and their effectiveness
Depression, OCD, Anxiety Depression
This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of HL-400 (a NLRP3 inhibitor) following oral single and multiple ascending dose administration.
Parkinson Disease
The primary purpose of this pilot study is to investigate a novel approach to the treatment of cognitive symptoms that persist despite prior antibiotic treatment for Lyme disease (Post treatment Lyme Disease or PTLD). Aim 1: The primary aim of this study is to assess whether the processing speed of individuals with PTLD can be enhanced by combining transcranial direct current stimulation (tDCS) with computer based cognitive training games. To achieve this aim, over a 4-week period, all individuals with PTLD will participate in at home adaptive cognitive training combined with either active stimulation or sham stimulation. Aim 2: To determine if treatment benefit in processing speed is sustained, the study will compare the sham and active groups 8 weeks after completion of study treatment.
Post-Treatment Lyme Disease
The purposes of this study are to determine: * The pharmacokinetics (the amount of study drug in your blood and how long it takes the body to get rid of it) of the study drug and its metabolites (substances produced as the body breaks down the study drug) in participants with moderate or severe liver function impairment compared to participants with normal liver function (also known as a healthy volunteer). Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug. * How well the study drug is tolerated and any side effects that may occur in participants with moderate or severe liver function impairment compared to participants with normal liver function. This study is for research purposes only and is not intended to treat any medical condition.
Healthy, Hepatic Impairment
The primary goal of this study is to investigate the efficacy of deutetrabenazine treatment of TD in this previously untreated patient population. Compare movement disorder deutetrabenazine treatment response in persons with IDD to response seen in patients without IDD treated with deutetrabenazine in other treatment settings (per literature review). Compare global deutetrabenazine treatment response with validated instruments. In addition, we plan to: * Assess the safety of deutetrabenazine in the treatment of TD in persons with IDD. * Assess change in Activities of Daily Living (ADLs) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated ADL instrument. * Assess change in Quality of Life (QOL) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated QOL instrument. * Assess caregiver burden with a validated caregiver burden instrument. In this study, 25 participants with IDD and TD will undergo Deutetrabenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks. This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to deutetrabenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication. This will be an open-label, Phase 4 study.
Tardive Dyskinesia, Intellectual Disability, Developmental Disabilities
This nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and understanding.
Cancer
The goals of this hybrid type 2 randomized controlled trial (RCT) are to evaluate the effectiveness and individual-level implementation of a 1-month app-based meditation program with youth on probation in Cook County, IL. The primary questions it is designed to answer are: 1. Is the meditation app associated with improvements in behavioral health outcomes including cannabis use problems? 2. Do improvements in emotion regulation appear to mediate the effects of the meditation app on these behavioral health outcomes? 3. Will youth adequately adhere to the meditation app?
Behavioral Health
This phase I trial tests the safety, side effects, and best dose of decitabine in combination with standard of care surgery, radiation, and/or chemotherapy and the effectiveness of the combination in treating patients with head and neck squamous cell cancers that are not caused by human papilloma virus (HPV-negative) and that can be removed by surgery (resectable). Decitabine, an antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Studies have shown that medications like decitabine can make some types of solid tumors more sensitive to chemotherapy. This allows the chemotherapy to be more effective, with slower progression and longer survival. Decitabine is also a clinically active demethylating agent, and may help make tumor cells more sensitive to radiation therapy. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. External beam radiation therapy (EBRT) is a type of radiation that uses a machine to aim high-energy rays at the tumor from outside the body. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving decitabine in combination with standard of care surgery, radiation and/or chemotherapy may be safe, tolerable, and/or effective in treating patients with surgically resectable HPV-negative head and neck squamous cell cancers.
Human Papillomavirus-Negative Neck Squamous Cell Carcinoma, Resectable Head and Neck Squamous Cell Carcinoma, Resectable Human Papillomavirus-Independent Head and Neck Mucosal Squamous Cell Carcinoma, HPV-Negative Squamous Cell Carcinoma, Resectable Head and Neck Squamous-cell Carcinoma
The purpose of this study is to determine the effects that Elranatamab in combination with Lenalidomide and Dexamethasone has on participants that have been newly diagnosed with Multiple Myeloma.
Multiple Myeloma
This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating oral cavity cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving the combination of methotrexate, erlotinib, and celecoxib may be feasible, safe, and effective in treating rural Midwest patients with recurrent/metastatic oral cavity cancer.
Metastatic Oral Cavity Carcinoma, Recurrent Oral Cavity Carcinoma, Stage IVC Lip and Oral Cavity Cancer AJCC v8
The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.
Advanced Solid Tumor, Advanced Breast Cancer, Advanced Ovarian Cancer
The goal of this interventional study is to learn if an Enhanced Recovery After Surgery (ERAS) protocol works to reduce the need for narcotic pain medications in live donor kidney transplant recipients. The main questions it aims to answer are: Does the ERAS protocol lower the amount of opioid narcotic medication needed to manage post-surgery pain? Does the ERAS protocol help lower pain scores after surgery? Researchers will compare the ERAS protocol to previous patients where the ERAS protocol was not used to see if the ERAS protocol works to reduce post-surgery pain. Participants will be asked to: * Drink a pre-surgery carbohydrate drink two hours before your surgery. * Take a pre-surgery dose of Tylenol by mouth. * Take a pre-surgery dose of Gabapentin by mouth. * The surgeon will administer a local numbing medication at the surgery site by injection during the surgery. * Begin walking with assistance about 12 hours after your surgery. * Allow the research staff to collect data about your kidney function. This data will be collected on your postoperative clinic visits, which generally occur about twice weekly for one month. This information will determine your kidney health, need for hospitalization, and side effects that may occur.
Postoperative Pain
The purpose of this study is to assess the relative bioavailability of a single dose AZD5004 in healthy participants, among 3 different oral tablet formulations.
Healthy Participants
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
Advanced or Metastatic Non-small Cell Lung Cancer
This is a study of gene therapy to treat alpha-1 antitrypsin deficiency. This study aims to treat AAT deficiency with a single administration of AAV8hAAT(AVL), a gene therapy that codes for an oxidation resistant form of the AAT protein, which if safe and if efficacious, will protect the lung on a persistent basis. We hope to learn the safety/toxicity and initial evidence of efficacy of intravenous delivery of this gene therapy to alpha 1-antitrypsin (AAT) deficient individuals.
Alpha 1-Antitrypsin Deficiency
This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.
REM Sleep Behavior Disorder
The goal of this clinical trial is to find out whether fasting is necessary before urgent inpatient cardiac catheterizations. For patients presenting with urgent heart-related pain or even mild heart attacks, researchers want to know whether eating and drinking before their procedure improves comfort without raising the risk of complications. The study will answer: * Does eating and drinking before the procedure improve patient comfort? * Does it increase the risk of adverse events like vomiting, aspiration (food or liquid entering the lungs), breathing problems, or death, etc? Participants will be randomly assigned to either: * A standard fasting group (no food for 6 hours, no clear liquids for 2 hours), or * A no-fasting group (able to eat and drink as usual). Patients will complete brief surveys before the procedure to assess comfort and satisfaction. Researchers will also review medical records weekly and 30 days later to monitor for safety outcomes.
Stable Angina (SA), Unstable Angina (UA), NSTEMI - Non-ST Segment Elevation MI
Alerts related to outlier clinician behavior are generated in real-time by an intelligent system continuously scraping EHR (electronic health record) data. These alerts are passed to the bedside and their potential impact on bedside clinical behavior is evaluated.
Critical Illness
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during headache and non-headache periods.
Hydrocephalus
Quantitative Sensory Testing (QST) is a novel investigative technique used in other pain conditions to evaluate patterns of chronic pain, and in this study will be used to elucidate pain patterns in patients with Chronic Pancreatitis (CP). QST uses a specific series of standardized stimulations to map the pain system. QST has the potential to change and improve the treatment paradigm for patients with CP and may eventually be able to predict response to invasive CP therapies.
Chronic Pancreatitis, Chronic Pain, Acute Recurrent Pancreatitis
The goal of this clinical trial is to learn if an educational tool helps postpartum patients after having high blood pressure during their pregnancy. The main question it aims to answer is: Does receiving our educational tool improve patient activation in the postpartum period? Researchers will compare a group of postpartum patients who get the tool 0-2 weeks after delivery with patients who do not get the tool to see if there is a difference in their activation scores 4-12 weeks later. Participants will: Complete a survey when we first speak with them Complete a similar follow-up survey 4-12 weeks later
Hypertension, Pregnancy Induced
The purpose of this clinical trial is to evaluate the level of comfort adult patients with cirrhosis of the liver and ascites presenting to Northwestern Memorial Hospital experience during a bedside abdominal paracentesis by numbing the skin with a needle-less device (the J-Tip), instead of using a needle to numb the skin. The main questions it aims to answer are the J-Tip effect upon: 1. Pain during intra-dermal local anesthetic administration 2. Pain during subcutaneous local anesthetic administration 3. Pain during paracentesis 4. Procedure-related anxiety Participants will be randomly assigned to have their skin numbed either in the usual way with a needle or with the J-Tip. Participants will be responsible for having a paracentesis done in their hospital room and answering the survey questions regarding pain experienced during the procedure and how they would feel if they needed to have this procedure performed again. There is also a telephone follow-up survey 2 days after the procedure to ask the participant about their experience post-procedure. We will also collect data about any procedure complications.
Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin
The goal of this randomized pilot study is to learn the impact of a primary care outreach intervention on the proportion of patients with Medicare insurance who are up-to-date on Medicare Annual Wellness Visit completion. At two clinics, researchers will randomize clinicians (and their associated, eligible patients) to early or delayed outreach.
Annual Wellness Visit
Managing complicated urinary tract infections (cUTIs) poses significant challenges, often resulting in the over-prescription of empiric antibiotics. This approach exposes patients to multiple antimicrobials and raises the risk of inadequate treatment efficacy. The purpose of this study is to assess and compare the clinical utility of molecular testing (PCR) versus conventional culture and sensitivity (C\&S) in managing cUTI, to identify optimal management strategies for cUTI patients. This was a multi-center (6 sites in the united states), randomized, parallel, investigator-blinded, clinical trial to assess the clinical utility of PCR by comparing the diagnostic and therapeutic outcomes of PCR diagnostic methods to those of conventional C\&S in managing cUTIs in adults. All patients who met all the inclusion criteria and non of the exclusion criteria and signed an informed consent form were enrolled and randomized to one of two testing protocols used to guide treatment (PCR guided Arm, and C\&S guided Arm). Patients were randomized in a 1:1 ratio based on their unique sequential randomization numbers assigned at enrollment. Urine samples were collected from all patients and tested using both PCR and C\&S methods before randomization; however, investigators remained blinded to the comparator test results throughout the trial. To ensure unbiased treatment decisions, clinicians were blinded to the comparator test results. Treatment was prescribed solely based on the assigned test-PCR results for the PCR arm and C\&S results for the C\&S arm. The comparator test results remained blinded until the end of the study (EOS) Urine specimens were collected using a clean-catch midstream technique at two distinct time points-at baseline visit/before randomization (Day1) and at EOS visit (Day 28)-following targeted therapy based on the assigned diagnostic arm. Collected samples were immediately stored at 2-8 ◦C until analysis to preserve sample integrity. Upon receipt, urine samples were aliquoted for parallel testing, with one portion analyzed using PCR (QuantStudio 7 or 12 and KingFisher) and the other processed using C\&S methodologies. Molecular testing (Doc Lab UTM 2.0) involved qualitative PCR amplification targeting 28 uropathogen species and 16 classes of antibiotic resistance genes, covering both bacterial and fungal pathogens. All urine samples for urine C\&S were shipped to the central laboratory. The urine culture, isolation of uropathogen(s), initial identification of pathogen(s), and bacterial counts in urine were conducted in the central laboratory. The urine samples were cultured and quantified using a calibrated loop to identify a quantitative count of bacteria at a lower limit of 10\^5 CFU/mL. All purified pathogen(s) were further analyzed for species identification and antimicrobial sensitivity The primary endpoint was the number (and percentage) of subjects in each study arm with favorable clinical outcomes (FCl) at the EOS visit. The FCl was defined as a patient's clinical response, assessed by the treating investigator, indicating either clinical improvement or cure. Clinical improvement was defined as the resolution of at least one symptom of cUTI present at baseline, absence of new cUTI symptoms, and/or avoidance of parenteral antibiotic therapy following randomization. Clinical cure was defined as the complete resolution of all acute signs and symptoms of cUTI present at baseline, to the extent that no further antimicrobial therapy (either IV or oral) was required for the treatment of the cUTI. The secondary endpoint included several assessments: * Number (and percentage) of subjects with microbiological eradication at the EOS, defined as achieving a quantitative urine culture at the EOS indicating a reduction of all uro-pathogens present at baseline to \<10\^5 colony forming unit per milliliter (CFU/mL) and the absence of baseline pathogens detected by EOS urine PCR (Cq \> 33); * Subjective measurement of treating investigator satisfaction score through a questionnaire at EOS, evaluated factors such as the ease of interpreting the test result, its availability, and its usefulness in clinical decision-making and patient management compared to the comparator; * Comparison of turnaround time between molecular diagnostic procedures and conventional diagnostic * Overall agreeability between the diagnostic results generated by PCR versus C\&S as assessed by discordant analysis * Assessment of the favorable clinical outcome of patients with discordant results \[PCR(+), CS(-) and PCR(-), CS(+)\]
Urinary Tract Infection Complicated, Urinary Tract Infection (cUTI), Urinary Tract Infection (Diagnosis)
This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor \[peripheral blood stem cell\] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When healthy stem cells for a donor are infused into a patient (allogeneic HCT), they may help the patient's bone marrow make more healthy cells and platelets. Allogeneic HCT is an established treatment, however, GVHD continues to be a major problem of allogeneic HCT that can complicate therapy. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Emapalumab binds to an immune system protein called interferon gamma. This may help lower the body's immune response and reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Mycophenolate mofetil is a drug used to prevent GVHD after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Mycophenolate mofetil is a type of immunosuppressive agent. Giving emapalumab with post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil may be safe, tolerable and/or effective in preventing GVHD in patients with AML or MDS after a reduced-intensity allogeneic HCT.
Acute Myeloid Leukemia, Graft Versus Host Disease, Myelodysplastic Syndrome
Medical marijuana use among adults 50 and older has more than doubled in the past decade with exponential increases projected in this demographic by 2050, and prescription opioids are one of the most common treatments for pain management in this population. To date, no studies systematically assess driving performance in a rigorous and ecologically valid manner accounting for long-term medical marijuana use and/or the combined effect of prescription opioid use in adults 50 and older who endorse chronic or severe non-malignant pain. Further, studies examining how older adults self-regulate prescription medication use and driving behavior is limited, with none rigorously examining medical marijuana.
Medical Cannabis
This pilot clinical trial looks at whether patient navigation services, an interactive web education intervention, called Current Together After Cancer (CTAC), or both navigation and CTAC works to improve the uptake of surveillance in patients with stage I-III colorectal cancer (CRC). Post-treatment surveillance is critical to detect recurrence early, yet many CRC survivors do not receive recommended surveillance care. Surveillance is a complex process that includes laboratory tests, cross-sectional imaging, and endoscopic procedures. Patient navigation services, interactive web education, or a combination of both may improve surveillance care for patients with stage I-III colorectal cancer.
Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
Background: A Timeline Follow-Back (TLFB) is a tool that helps researchers track how much of a substance a person uses. Different versions of the tool are used to track the use of alcohol, cigarettes, and cannabis. But there is no TLFB to track a person s use of nonmedical opioids. (These are opioids not obtained from a medical source; they may also be called "street" opioids.) Researchers are creating an Opioid TLFB (OpiTLFB) that asks better questions and records more useful answers to identify what kinds of nonmedical opioids people are using. Objective: To test a new research tool to track a person's use of nonmedical opioids. Eligibility: People aged 18 years or older who used a nonmedical opioid within the past 30 days. Design: Participants will have 1 study visit at a clinic in Baltimore, Maryland. The visit will take 1 to 4 hours. Participants will sit at a computer with a researcher and fill out a calendar. They will record their use of opioids each day for the past 30 days. They will be asked what the drugs were called and what they looked like. This task might take 30 minutes. Participants will be interviewed. The researcher will ask about their experiences getting opioids from friends, dealers, or other sources; how the experience of getting opioids has changed over time; and about any changes they have noticed across different areas of Baltimore. Researchers will ask how the OpiTLFB could be easier to fill out and how it could provide more useful information. This task might take 30 minutes. Participants will provide a urine sample.
Substance Use Disorders (SUDs)
Background: Neuroblastoma is a type of cancer that causes tumors in nerves. It affects mainly infants and toddlers, and it causes about 15 percent of cancer-related deaths in children. Objective: To test a new drug (rhIL-15), combined with 3 standard cancer drugs, in people with neuroblastoma. Eligibility: People aged 3 to 35 years with neuroblastoma that did not respond or returned after standard treatment. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of their heart and lungs. They will have a bone marrow biopsy: A sample of tissue and fluid from inside a bone will be removed with a large needle. Participants will be treated in 21-day cycles. They may have up to 4 treatment cycles. rhIL-15 is given through a needle into a vein over 5 to 7 days during the first week of each cycle. Participants will stay in the hospital while they are receiving the rhIL-15. Starting in the second week of the second cycle, participants will receive other drugs for treating cancer. They will have no study treatments during the third week of each cycle. Participants will visit the clinic at least 2 times a week throughout all 4 treatment cycles. They will have a physical exam and blood tests during these visits. Imaging scans, bone marrow biopsy, and other tests will be repeated at the end of cycles 2 and 4. Participants will have a follow-up visit 6 months after treatment ends. This visit will include a physical exam with blood and urine tests.
Neuroblastoma
The main objectives are to determine sweat sodium concentration \[Na+\], whole body sweat rate (WBSR) and rate of sweat sodium loss (RSSL) in female athletes aged 13 and above during their normal planned training session across various sports (basketball, soccer, volleyball, cheer, flag football and softball).
Sweat Rate