Bucramanga, Colombia

Mentalizing and Epistemic Trust in Patients with Anxiety and Depression.

QUALITY ASSURANCE PLAN. The researchers will review and report the process during the trial covering participant enrolment, consent and eligibility to protect participants, including reporting of harm and completeness, accuracy and timeliness of data collection. STANDARD OPERATING PROCEDURES. Participants will be identified from community mental health services who meet all the study eligibility criteria (listed in section Eligibility). Participants will be recruited over a period of 20 months by mental health professionals (clinical psychology residents). Community sample for validation will be recruited by social media. Participants will not receive financial reimbursement for taking part in this trial. DATA DICTIONARY. All variables collected in this study are listed and described in an electronic case report form, with associated guidelines, to ensure consistency in all gathered data. The following data will be collected in this trial: Sociodemographical data. Anxiety symptoms: Generalized Anxiety Disorder 7-item scale (GAD-7) Depressice symptoms: Patient Health Questionnaire-9 (PHQ-9) Epistemic Trust: The Epistemic Trust Questionnaire (QET) Epistemic Trust, Mistrust and Credulity: The Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ). Reflective functioning: The Reflective Functioning Questionnaire (RFQ-8) Functional impact: The Work and Social Adjustment Scale (WSAS) Satisfaction with therapy: The Consumer Reports Effectiveness Score (CRES-4) SAMPLE SIZE ASSESSMENT. The study has sensitivity to detect effect sizes that are considered clinically significant (Cohen's d =0.50) for a power of 0.8, an Alpha of 0.05 and an estimated sample of 100 participants. The calculation was performed with the GPower 3.1.9.2 program for a mean difference with a t-test for two independent groups. For the validation of the QET, taking into account the subject-item ratio of at least 5: 1 (24 items), and considering the minimum number of recommended subjects to perform an Exploratory Factor Analysis, the minimum number of participants must be 150.Thus, estimating losses of 20%, the total number of participants estimated for the validation is n = 180 . STATISTICS ANALYSIS PLAN. The analysis will be made following an intention-to-treat procedure. The change of means in the primary outcome variable between the two study groups will be analyzed with the Student's t-test for independent samples if the criteria for its application are met. If the criteria for its application are not met, nonparametric tests will be used. For continuous secondary variables, this test will also be used. A multivariate analysis of variance (ANCOVA) will also be considered to introduce any possible covariate that differs between the two comparison groups in the first evaluation. Potential confounding variables will include gender, age, previous level of depression and anxiety, and diagnosis. A 95% confidence level will be used for all comparisons. The R program will be used for all statistical analyses. PLAN FOR MISSING DATA. Each researcher is responsible for ensuring that any missing data will be reported as missing in the study database. Procedures can sometimes be considered when using statistical methods that fail in the presence of any missing values, or when in the case of multiple-predictor statistical models all the data for an individual would be omitted because of a missing value in one of the predictors. For analyses involving multiple regression analysis, a multiple imputation approach will be considered and used if statistically sound, depending on the proportion and pattern of missing values. METHODS TO ENSURE VALIDITY AND QUALITY OF DATA. Accurate and reliable data collection will be assured by verification and cross-check of the case report form (CRF) against the researcher´s records (source document verification). Source document verification will be conducted for 5% of data in subjects. Discrepancies and queries will be generated accordingly in the CRF for online resolution by the researcher at the site. In addition, the CRF data will be reviewed on an ongoing basis for medical and scientific plausibility.

Integrated Approach in Frail Older People with Atrial Fibrillation

Controlled study, testing a structured implementation of an appropriate management of elderly AF patients with multimorbidity in clinical practice (adapting the ABC pathway and integrating the means of CGA) versus usual care; it is designed to provide reliable evidence of an active holistic integrated management approach to a common, multimorbid and 'high risk' clinical condition. AFFIRMO use a novel platform (iABC) in a cluster randomized trial design, randomizing centres to iABC versus usual care. Centres will be selected in each participating country (Bulgaria, Denmark, Italy, Romania, Serbia and Spain) under the responsibility of National Coordinators on the basis of a demonstrated interest in managing patients with AF. The 8-10 participating clusters in each country (see study size below) will be randomized in a 1:1 ratio to receive a quality-improvement intervention (iABC, experimental group) or 'usual care' practice (control group). The randomization will occur in each Country once all clusters selected in the Country have obtained IRB approval. The allocation schedule for random assignment of care models (iABC or usual care) to sites will be computer generated at the Central Coordinating Centre. The clusters in each Country will be stratified in 2 groups: Centres with or without interventional electrophysiology laboratory for AF ablation.

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Study of Navtemadlin Add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Study of RAS(ON) Inhibitor Combinations in Patients With Advanced RAS-mutated NSCLC

The platform study design allows combinations of RAS(ON) inhibitors with other anticancer agents to be evaluated in patients with RAS-mutated solid tumors with a focus on NSCLC. This is an open-label platform Phase 1b/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard of Care (SOC), and to define the Recommended Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with KRAS or RAS mutations will be specified in each subprotocol. Subprotocol A is an open-label, multicenter, Phase 1b/2 study of RMC-6291, with or without RMC-6236, in combination with pembrolizumab, with or without chemotherapy, in patients with KRAS G12C-mutated advanced solid tumors. Subprotocol B is an open-label, multicenter, Phase1b/2 study of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with RAS-mutated non-small cell lung cancer (NSCLC) Subprotocol C is an open-label, multicenter, Phase1b/2 study of RMC-9805 with or without RMC-6236, in combination with other anticancer agents, in patients with RAS G12D-mutated non-small cell lung cancer (NSCLC) Each subprotocol consists of two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.

Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants with Steroid-Refractory Acute Graft Versus Host Disease