Secondary Objectives. To assess the steady-state pharmacokinetics (PK) and pharmacodynamics (PD) of RP103.
Secondary Objectives. The following objectives will compare full dose subjects to low dose subjects in Stage 1: • Assess changes in self-reported PTSD symptoms in participants receiving the full dose and low dose MDMA as measured with the PTSD Diagnostic Scale (PDS) at baseline, after each experimental session and/or the primary endpoint. • Assess depression symptoms with the Xxxx Depression Inventory- II (BDI-II) at baseline and the primary endpoint. • Assess quality of life with the Global Assessment of Functionality (GAF) at baseline and the primary endpoint. • Assess self-reported sleep quality with the Pittsburgh Sleep Quality Index (PSQI) at baseline and the primary endpoint. The following objectives will compare effects in specified subjects: • Assess PTSD symptoms via CAPS and PDS, depression symptoms via BDI-II, quality of life via GAF and sleep quality via PSQI throughout Stage 2 in comparison to Stage 1 in crossover subjects. • Assess long-term effects of MDMA-assisted psychotherapy on symptoms of PTSD, depression, sleep quality, and global function via CAPS and PDS, BDI-II, PSQI and GAF one year after the final experimental session for each subject. The following objectives will include exploratory analyses intended to inform protocol design: • Explore the effects of each experimental session upon self-reported changes in consciousness, as those associated with a transformational or mystical experience via the States of Consciousness Questionnaire (SOCQ). • Assess the effect of the third experimental session for full dose subjects in Stage 1 and Stage 2 using CAPS, PDS, BDI-II, GAF and PSQI. • Assess the ability of the investigators and subjects to accurately guess condition assignment in Stage 1. • Correlate adherence to the treatment manual with Global CAPS scores using adherence criteria ratings to assess videos of psychotherapy sessions. • Correlate development of therapeutic alliance with Global CAPS scores using the Segmented Working Alliance Inventory-Observer Form (S-WAI-O) to assess videos of psychotherapy sessions.
Secondary Objectives. The secondary objective of the First part (Part A) of this study is • To make a p reliminary assessment of the anti-tumour activity of AZD5363 when combined with paclitaxel by assessment of objective response rate (XXX), and the percentage of patients without progressive disease, at 12 weeks. • To assess the PK of AZD5363 when combined with paclitaxel • To assess the PK of paclitaxel alone and when combined with AZD5363 • To assess the pharmacokinetic/pharmacodynamic (PK/PD) relationship between plasma AZD5363 exposure and plasma concentrations of biomarkers (including phospo-PRAS40, total PRAS40, pAKT and pGSK3β) anti-tumour activity (assessed by RECIST 1.1)
Secondary Objectives. The secondary objectives of the second part (Part B) of this study are: ! To assess the relative efficacy of AZD5363 when combined with weekly paclitaxel compared with weekly paclitaxel plus placebo by assessment of objective response rate (XXX) at 12 weeks, best objective response (BOR), durable response rate (DRR) and duration of response (DoR). ! To assess the relative anti-tumour activity of AZD5363 when combined with weekly paclitaxel vs. weekly paclitaxel plus placebo by comparison of change in tumour size at 12 weeks (target lesion assessment using Response Evaluation Criteria In Solid Tumours [RECIST 1.1]). ! To compare overall survival (OS) in patients treated with AZD5363 in combination with weekly paclitaxel compared with weekly paclitaxel plus placebo by assessment of time to death. ! To further assess the safety and tolerability of AZD5363 when combined with weekly paclitaxel compared with weekly paclitaxel plus placebo. ! To investigate the effect on patients’ quality of life (QoL) of AZD5363 when combined with weekly paclitaxel compared with weekly paclitaxel alone by change from baseline, utilising a patient-completed QoL questionnaire. ! To assess the pharmacokinetics (PK) of AZD5363 when combined with paclitaxel. ! To assess the PK of paclitaxel alone and when combined with AZD5363. ! To assess the Pharmacokinetic /Pharmacodynamic (PK/PDc) relationship between plasma AZD5363 exposure and plasma concentrations of biomarkers (including
Secondary Objectives. The secondary objectives of this study are to: ▪ Evaluate changes on other clinical outcomes (growth, lung function, gastrointestinal symptoms, hospitalizations, antibiotic utilization and PEs) ▪ Evaluate changes in blood and fecal inflammatory markers
Secondary Objectives. 1. Evaluate the toxicity of the combination of paricalcitol plus pembrolizumab versus pembrolizumab alone.
Secondary Objectives. 1.3.1 To compare the proportion of participants in each treatment arm with drug-resistant virus at entry and at virologic failure, as determined by bulk sequencing.
Secondary Objectives. Secondary objectives are: • To determine if treatment with SAGE-217 reduces anxiety symptoms compared to placebo • To assess self-report of depressive symptoms • To evaluate the safety and tolerability of SAGE-217 •
Secondary Objectives. The secondary analysis of the change from baseline in SNOT-22 will estimate the mean difference in SNOT-22 from baseline to 1-, 3-, and 6-months and will use mixed effects models for repeated measures when appropriate (similar approach as the one used for the primary objective). The change from baseline in VAS score for smell dysfunction will estimate the mean difference in VAS score for smell dysfunction at 1-, 3-, 6-, and 12-months and will use mixed effects models for repeated measures when appropriate (similar approach as the one used for the primary objective). The change from baseline in VAS score for nasal obstruction will estimate the mean difference in VAS score for nasal obstruction at 1-, 3-, 6-, and 12-months and will use mixed effects models for repeated measures when appropriate (similar approach as the one used for the primary objective). The change from baseline in NP score will estimate the mean difference in NP score per nasal endoscopy and/or CT scan at 1-, 3-, 6-, and 12-months and will use mixed effects models for repeated measures when appropriate (similar approach as the one used for the primary objective). The annualised rate of clinically significant asthma exacerbations 12-month pre- and 12-months post-mepolizumab treatment periods will be computed and described by using the information below. The definition for clinically significant asthma exacerbations according to the European Respiratory Society/American Thoracic Society consensus (and in order of decreasing severity) is: • Hospitalisation: any asthma-related referral or hospitalisation with a discharge diagnosis of asthma; • ER visits: any record of an ER visit related to an asthma diagnosis code; • OCS-defined: treatment with OCS burst for ≥3 days, but ≤28 days (or 4 weeks) with an asthma or CRSwNP exacerbation code recorded within ±2 weeks. For maintenance OCS users, increase of the prescribed dose by at least 2 times, for ≥3 days, but ≤28 days (or 4 weeks) with asthma or CRSwNP exacerbation code recorded within ±2 weeks. All other OCS therapy use is considered maintenance therapy or non-asthma-related. Asthma exacerbations occurring within 7 days of each other will be considered a single episode. All these categories of asthma exacerbations are considered as clinically significant for the patient. To assess the annualised rate of asthma exacerbations, sites will collect the following information: • Number of asthma exacerbations in 12 months prior to treatment initiation ...
Secondary Objectives. The first secondary objective of this study is to demonstrate superiority of the TFNT00 IOL versus the 839MP IOL in mean photopic binocular uncorrected intermediate (60 m) visual acuity (UCIVA) at Visit 4A (120-180 days post 2nd eye implantation). The second secondary objective of this study is to demonstrate noninferiority of the TFNT00 IOL versus the 839MP IOL in mean photopic binocular uncorrected distance (4 m) visual acuity (UCDVA) at Visit 4A (120-180 days post 2nd eye implantation). The third secondary objective of this study is to demonstrate noninferiority of the TFNT00 IOL versus the 839MP IOL in mean photopic binocular uncorrected near (40 cm) visual acuity (UCNVA) at Visit 4A (120-180 days post 2nd eye implantation). The fourth secondary objective of this study is to demonstrate superiority of the TFNT00 IOL versus the 839MP IOL in mean photopic binocular uncorrected near (40 cm) visual acuity (UCNVA) at Visit 4A (120-180 days post 2nd eye implantation). The fifth secondary objective of this study is to demonstrate superiority of the TFNT00 IOL versus the 839MP IOL in mean photopic binocular uncorrected distance (4 m) visual acuity (UCDVA) at Visit 4A (120-180 days post 2nd eye implantation). The sixth secondary objective of this study is to characterize the Binocular Defocus Curve profiles, contrast sensitivity and patient satisfaction with the TFNT00 IOL versus the 839MP IOL at Visit 4A (120-180 days post 2nd eye implantation).
