3,064 Clinical Trials for Various Conditions
The goal of this clinical trial is to determine whether Emotional Brain Training (EBT), a behavioral modification method, can help manage stress and health problems related to addiction. EBT teaches skills to deactivate harmful circuits (automatic reactions) and activate healing circuits to quickly shift mood from negative to positive. Participants in the EBT group will receive focused, intensive instruction on using these skills to rewire unwanted brain circuits, with the aim of achieving lasting improvements in emotional health and quality of life. The study will assess whether EBT is an effective tool when added to standard of care (SOC), which includes medications for addiction treatment (MAT). Researchers will compare changes in stress, anxiety, and cravings after 8 weeks of EBT plus SOC versus SOC alone. Participants: * will either continue receiving standard treatments (SOC) at the Addiction Recovery Clinic (ARC) at SAC Health in San Bernardino * or receive both EBT and SOC at ARC * in the SOC group will continue monthly visits at ARC and weekly counseling * in the EBT plus SOC group will continue monthly visits and weekly counseling at ARC, along with weekly EBT group sessions by telephone * will complete online assessments at weeks 0, 4, and 8 Upon completion of the study, all participants will resume SOC
The goal of this clinical trial is to learn if mobile mindfulness training can help people in treatment for opioid use disorder. The main questions it aims to answer are: * Will people with opioid use disorder and childhood trauma use mobile mindfulness training? * Will mobile mindfulness training help people with opioid use disorder and childhood trauma have decreased markers of psychological stress? Participants will: Be given access to mobile mindfulness training and encouragement to use it daily for 30 days. Keep a diary of how often mobile mindfulness training is used. Visit the clinic four times to measure stress levels, including written rating scales, blood work, and heart rate tests.
This was a non-interventional, secondary use of data, retrospective, cohort study. The data extracted in this study was used as secondary use of collected patient information in the database, Japan Medical Data Survey (JAMDAS), owned by M3 Inc. (Tokyo, Japan). JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of medical institutions, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities etc.
This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden.
High blood pressure (BP) is a public health problem worldwide. Nearly three-quarters of older adults (age \~60 years) in the United States have high BP. High BP links to many health problems, like stroke. Drug treatments are typically used in clinics to reduce high BP and the risk of associated health problems. However, these drug treatments may not always benefit brain health. For example, drug treatment may reduce brain blood flow, which may reduce cognitive function in older adults with high BP. Alternatively, reduced brain blood flow may cause high BP due to increased nervous system activity (the so-called "fight or flight response"). Thus, monitoring brain blood flow may help to manage high BP during drug treatment. It is unknown if brain blood flow and its control will be altered by drug treatment in older high BP patients. Therefore, study team will recruit older adults with high BP, who receive either drug treatment or a placebo for 2 weeks and will assess brain blood flow, cognitive function, and nervous system control before and after treatment. Results from this study will provide novel and clinically relevant information on the impact of drug treatment for high BP on brain health. Investigators expect these results will suggest that it is crucial to measure brain blood flow, which may be a therapeutic new target for BP control and brain health.
This project aims to improve the understanding of the impact of Ethnic and Racial Discrimination (ERD) on adolescent alcohol and other drug use (AOD) within the Black Justice-Involved Youth (JIY) population. Individual interviews with Black JIY and focus groups with parents and guardians of Black JIY and community members who support change and reform in the justice community for Black JIY will be conducted.
The purpose of this study is to evaluate whether an intervention called Pediatric Medication Therapy Management (pMTM) improves the identification and management of medication-related problems among children with medical complexity and polypharmacy.
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.
The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.
This study is the first to systematically evaluate the efficacy of single and combined academic accommodation, behavioral treatment, and medication treatment in a large sample of children with ADHD. Using a scientifically rigorous, cross-over design the impact of these approaches on ecologically valid measures of outcome (on-task behavior, quiz scores, academic productivity) will be assessed to inform effective school intervention.
This project will provide novel empirical information about how to optimally engage pharmacists and pharmacies as key partners in collaborative integrated care models designed to expand access to evidence-based medication treatment for OUD which may inform a larger experimental design that seeks to evaluate best ways to scale-up this model across the nation. This Phase 1 project seeks to evaluate the feasibility, acceptability, and impact of implementing a pharmacist-integrated model of MOUD into approximately four diverse outpatient clinical sites.
A pilot study to assess the risk of progression after stopping post-autologous stem cell transplant (ASCT) maintenance therapy in Minimal Residual Disease (MRD)-negative MM patients.
The purpose of this study is to obtain archived tumor tissue or pre-existing antigen expression data from patients with Head and Neck, Cervical, Melanoma and Non-Small Cell Lung Cancers to assess antigen expression and patient suitability for a Repertoire Immune Medicines Treatment Protocol.
In the present study, investigators aim to (1) adapt the Making Connections Intervention (MCI) as an intervention to address telehealth engagement and examine whether this targeted intervention can improve youth engagement in telehealth treatment; and (2) assess attitudes towards help-seeking and therapeutic alliance from both the youth and clinician viewpoint to examine the impact of these factors on engagement in telemental health treatment. Forty adolescent participants ages 12-18 will be randomized to either telehealth treatment as usual (TAU) plus the telehealth Making Connections Intervention (MCI-T) engagement session or telehealth TAU alone and followed for 12 weeks from baseline assessment. All clinicians will receive training in the MCI-T intervention and provide either MCI-T + usual care or usual care only depending on the condition to which the adolescents are randomized. All evaluations and therapy sessions will be done over telehealth platform.
This observational study is designed to evaluate the integration of a model-informed, clinically individualized pharmacokinetics (PK) profile (precision dosing dashboard) into prescribing clinicians' existing workflows to improve safety and efficacy of morphine dosing for neonates. The investigators will use user-centered participatory design methods and real-time analysis to inform the refinement of the recently developed Electronic Health Record (EHR) model-based decision support tool and test it during the pre-and post-implementation stages.
This phase II/III trial compares the side effects and activity of oral azacitidine in combination with the standard drug therapy (reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-miniCHOP\]) versus R-miniCHOP alone in treating patients 75 years or older with newly diagnosed diffuse large B cell lymphoma. R-miniCHOP includes a monoclonal antibody (a type of protein), called rituximab, which attaches to the lymphoma cells and may help the immune system kill these cells. R-miniCHOP also includes prednisone which is an anti-inflammatory medication and a combination of 3 chemotherapy drugs, cyclophosphamide, doxorubicin, and vincristine. These 3 chemotherapy drugs, as well as oral azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combining oral azacitidine with R-miniCHOP may shrink the cancer or extend the time without disease symptoms coming back or extend patient's survival when compared to R-miniCHOP alone.
Obstructive sleep apnea (OSA) is common and associated with many adverse health consequences, but many patients are unable to tolerate standard therapies such as continuous positive airway pressure (CPAP) and thus remain untreated. Single-drug therapies have shown promising results in treating sleep apnea, but on average patients have only experienced partial relief. Multi-drug therapy may offer a more effective treatment approach. The goal of this study is to test the effect of combination therapy with three FDA-approved drugs (Diamox \[acetazolamide\], Lunesta \[eszopiclone\] +/- Effexor \[venlafaxine\]) on OSA severity and physiology.
The investigators will link community pharmacy and primary care practices via a shared electronic health record to improve medication therapy management for older patients taking complex prescription (Rx) regimens. The Technology-Enabled Alliance for Medication Therapy Management (TEAM) intervention will link a major, national community pharmacy chain (Walgreens) to primary care practices (Access Community Health Network) via a shared electronic health record (EHR) platform (Epic, Verona WI). Through shared access to patients' medical records, pharmacists can perform comprehensive medication therapy management services, document and communicate patients' Rx challenges for review and action by primary care providers. The aims of this investigation are to: 1. Evaluate the fidelity and efficacy of the TEAM intervention to promote healthcare provider counseling, medication reconciliation, and safe regimen use among adults taking complex Rx regimens. 2. Explore patient, healthcare provider (pharmacist, prescriber), community pharmacy and/or primary care practice barriers to implementation. 3. Determine the costs of the TEAM intervention from both a community pharmacy and primary care practice perspective.
This phase I/Ib trial studies the side effects and best dose of parsaclisib with or without polatuzumab-vedotin (Pola) plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone \[PaR-CHOP\]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab-vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as anti-CD79b receptors, and delivers vedotin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.
The primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs.
This study will measure the effect of a novel pharmacy practice model on pediatric patients with hypertension. In North Louisiana, many patients have to travel to see subspecialists for treatment for hypertension and elevated blood pressure, which has many costs including direct medical costs, direct nonmedical costs, and indirect costs like missed time from work, school, or social obligations. Also, many patients who have to travel to get to their appointments have a high rate of missed appointments, which can be bad for overall health. This study will use a pharmacist to perform collaborative drug therapy management with pediatric cardiologists to manage therapy for patients with hypertension or elevated blood pressure. Patients will monitor blood pressure at home and follow up with the pharmacist by telecommunications. Pharmacist drug therapy management and telemedicine have been studied separately, but this is the first study with pharmacist drug therapy management by telemedicine for pediatric patients. If this model is successful, it could be replicated in other rural areas to improve patient care and reduce healthcare costs.
The national opioid epidemic requires development of real-world evidence-based treatments for opioid use disorder, including adjuncts to Medication for Opioid Use Disorder (MOUD). Interventions are needed that address the complex needs of patients with opioid use disorder, which include substantial mental health co-morbidity and high rates of chronic pain related to the complex interaction of opioid prescribing for pain and opioid use disorder. This study leverages recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MOUD in multiple clinical settings funded primarily through the Washington Opioid State Targeted Response (STR) program. MABT, a novel mindfulness-based intervention, uniquely addresses aspects of awareness, interoception, and regulation that may be associated with pain, mental health distress, and behavioral control that increase risk of relapse and poor treatment outcomes. Using a randomized, two-group, repeated measures design, we will compare those who receive MABT+ MOUD vs. MOUD only. The overarching goal of this application is to test MABT to improve MOUD health outcomes. The specific aims for the combined R33/R01 clinical protocol are to: 1) evaluate the effectiveness of MABT + TAU (MOUD) compared to TAU only in reducing opioid use and other substances; 2) examine the effectiveness of MABT + TAU to improve mental and physical health vs. TAU only; 3) examine the effectiveness of MABT + TAU to positively affect substance use related outcomes of craving and treatment retention vs. TAU only. For the R01, there is an additional aim to explore the effectiveness of additional MABT dose offered at 6 months to those with continued substance use (non-responders) compared to those with continued substance use at 6 months in TAU. A two-group (n = 165/165), randomized controlled repeated measures design will be employed. Three hundred thirty individuals engaged in MOUD will be recruited for participation at outpatient treatment sites. Assessments will be administered at baseline, post-intervention (3 months from baseline), and at 6, 9, and 12 months. Results of this study will inform the evidence base for behavioral treatment adjuncts to MOUD and directly impact the future direction of the Washington Opioid STR program.
This phase IV study is a prospective open-label multi-center study to investigate the effect of a temporary individualized poly-pharmaceutical De-escalation treatment with the target to regenerate ß-cell function over 12 weeks on the disease stage and glycemic control in patients with type 2 diabetes. This is an uncontrolled pilot study to collect data for later confirmatory trials.
Torsade de pointes (TdP) is a cardiac arrhythmia associated with QT interval prolongation which may lead to cardiac arrest. Prescription medications which cause QT interval prolongation are commonly used in daily practice. To lessen risk of TdP, pharmacists work to minimize combinations of QT interval prolonging drugs. If community pharmacists had real-time information about a patient's QT interval duration, this would have the direct ability to inform their decision making about which patients may be at highest risk of TdP and who may need heightened avoidance of QT prolonging drugs. This project will provide 3 community pharmacies with mobile ECG devices to easily determine QT intervals among patients who have a prescription profile alert for QT interval prolongation. Study outcomes will include: frequency of QT interval prolongation, changes in drug therapy related to QT interval determination, and patient and pharmacist satisfaction with having pharmacist assessment of QT interval.
Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH) is a multi-center, randomized parallel group study targeted to an at-risk population of Adolescents and Young Adults (AYA) with uncontrolled asthma who have poor adherence with prescribed Inhaled corticosteroid (ICS) therapy.
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment. A total of 250 untreated individuals meeting criteria for opioid use disorder and at high risk of opioid overdose will be enrolled in the study. Recruitment will take place in two targeted neighborhoods of Philadelphia (Kensington and South Philadelphia) with a high prevalence of fatal and non-fatal opioid overdose. A total of 250 participants will be engaged in the research. Following informed consent and determination of eligibility, 125 individuals will be enrolled as they engage with the mobile, rapid induction team and 125 individuals will be enrolled as they seek treatment from the CRC Episcopal Hospital (serving Kensington area) or BAC/CRC Hall Mercer Community Mental Health (serving South Philadelphia). The intervention group will receive four weeks of treatment with buprenorphine /naloxone and support for treatment engagement provided by a case manager and a peer recovery specialist. All participants will be assessed at baseline and then 1- and 6-month following enrollment. The primary endpoint for the study is continued enrollment in medication-assisted treatment at 6-month post-enrollment. The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment. The specific aims are: * Aim 1: To evaluate the impact of the mobile, transitional MAT intervention on its ability to engage participants in targeted, existing MAT treatment slots at 1- and 6-month post-enrollment. * Aim 2: To evaluate the impact of the mobile intervention on subsequent drug use and overdoses at 6-month post-enrollment. * Aim 3: To assess the acceptability and costs of the intervention. The program and patient costs of delivering and participating in the intervention will be documented.
To determine if the prior prolonged use of medication, as a treatment for benign prostatic hyperplasia, reduces the efficacy of Holmium laser enucleation of the prostate (HoLEP) for patients with benign prostatic hyperplasia (BPH).