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Filter by:a prospective open-label, randomized controlled study to evaluate the efficacy of the addition of metformin to SGLT2 in diabetic patient with preserved ejection fraction
Background Recent literature suggests that ADHD is a risk factor for the development of antisocial behavior that is more severe and persistent than in community and other psychiatric populations. The combination of stimulant medication and psychotherapy (particularly cognitive-behavioral therapy, CBT) is considered an evidence-based intervention for adults with ADHD. In contrast, few studies have evaluated the efficacy of medication in adult prisoners with ADHD, and the literature on the efficacy of psychotherapy is virtually nonexistent. Therefore, this article presents the protocol of a trial that will assess the efficacy of a formulation-based CBT program for inmates with ADHD. Methods The study has a multicenter randomized controlled trial design. After screening and recruitment, participants will be randomly assigned to the CBT intervention, a general offender treatment program, or a waitlist. Pre- and post-treatment self-report and clinician-report assessments, as well as 6- and 12-month follow-up assessments will be conducted. These will include both clinical (e.g., ADHD symptoms, depression and anxiety symptoms, self-esteem, alcohol/drug abuse, treatment adherence, quality of life) and criminological (e.g., recidivism and risk of recidivism) measures. Linear mixed models will be used to assess differences between groups. Discussion This study may be the first to evaluate the efficacy of a psychotherapy intervention in adult inmates with ADHD. It is expected that addressing the specific needs of ADHD would not only result in the previously reported clinical improvements (e.g., reduction in ADHD and comorbidity symptoms), but also reduce the risk and rate of recidivism compared to the general intervention or no intervention. However, the design may be limited by the difficulties inherent in the prison setting and in following up the sample after release.
This will be a double-blind, individually randomised trial, to assess the safety, tolerability, immunogenicity, and protective efficacy of two and three doses of the R21/Matrix-M1 malaria vaccine or placebo given at 4 week intervals in healthy women of childbearing potential (WOCBP), who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future. Participants will be randomised in Year 1 into three groups in a 1:1:1 ratio: - Arm 1 (n=110): will receive three doses of R21/Matrix-M1 malaria vaccine at months 0, 1 and 2. - Arm 2 (n=110): will receive normal saline (placebo) at month 0 and two doses of R21/Matrix-M1 malaria vaccine at months 1 and 2. - Arm 3 (n=110): will receive three of doses normal saline (placebo) at months 0, 1 and 2. In Year 2: Non-pregnant participants in arms 1 and 2 will be randomised in a 1:1 ratio to receive a booster dose of R21/Matrix-M1 malaria vaccine or placebo at the beginning of the malaria transmission season. Participants in the control group (arm 3) will receive normal saline (placebo). Initial follow-up will be for two years after dose three, with an efficacy analysis at 6, 12, 18 and 24 months after dose 3. Participants will be monitored for safety, tolerability, immunogenicity, and malaria infection during the follow-up period. Participants will also be monitored for pregnancy over 12 months post primary and booster vaccination and those who become pregnant will be followed during their pregnancy and for 1 year post-delivery (as well as their offspring) for safety and malaria infection
The purpose of this study is to assess the effects of Cetyl Tranexamate Mesylate on acne-related hyperpigmentation through a specific delivery form known as TeraCeutic TXVector.
Lung Ultrasonography score (LUS) using B-lines is a noninvasive, reliable and promising method for determining the extravascular lung water (EVLW). This was previously evaluated by trans-pulmonary thermodilution technique. The transurethral resection of the prostate syndrome (TURP-S) is a potentially life-threatening complication of the TURP surgery and timely diagnosis of TURP-S is crucial for rapid detection and optimized treatment. This observational study is designed to investigate the use of LUS using B-lines as a bed-side, simple, and non-invasive indicator for predication of the presence of systemic volume overload in patients undergoing endoscopic TURP.
This is a single-center, prospective, single-arm Phase II clinical study to evaluate the efficacy and safety of IBI110 in combination with Sintilimab in subjects with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed first-line treatment with PD-1 inhibitors combined with chemotherapy. Patients who meet the inclusion criteria will be treated with IBI110 combined with Sintilimab until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of therapy for other reasons specified in the protocol. RECIST v1.1 was used for clinical tumor imaging evaluation every 6 weeks during treatment.
radial artery cannulation is performed by an experienced person, non-invasive blood pressure measurement will be made at 3 stages of the operation (dissection, anhepatic, neohepatic) and the effects of radial artery cannulation on the perfusion index will be evaluated by recording the correlation between radial artery and invasive measurements and the perfusion indexes of both hands simultaneously with Masimo.
The main purpose of this study is to see if treating cancer with the magnetic resonance imaging guided adaptive radiotherapy (MRIdian) can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).
The goal of this investigator initiated interventional study is to improve the response to the anticancer treatments (chemotherapy) in people who have previously untreated metastatic pancreas cancer. The main question it aims to answer is: • Do new types of immune-based therapies, called botensilimab, and balstilimab, when given in combination with chemotherapy consisting of nab-paclitaxel + gemcitabine + cisplatin, and oral medications of chloroquine and celecoxib help patients with previously untreated metastatic pancreatic cancer? Participants will be administered two immune-based therapies: - Botensilimab (also referred to as AGEN1811) - Balstilimab (also referred to as AGEN2034) Patients will be evaluated when given in combination with: - Triple chemotherapy (nab-paclitaxel + gemcitabine + cisplatin), plus two oral medications: - chloroquine - celecoxib
The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035). The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits, Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.