Secondary Objectives Sample Clauses

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 ▇▇▇▇ 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. To obtain prospective pilot experience with recommended scrambler therapy, with regards to treatment efficacy to determine effect size estimates, patient related outcome measurement tools that we use in this trial, tolerability, and analgesic use.

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. To evaluate the safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in the treatment of military-related PTSD.

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. 1.3.2 To determine the tolerability and safety of the study drug regimens. To evaluate the effect of prior NVP exposure on virologic failure through the assessment of genetic relatedness of HIV minority variants present at baseline with HIV variants selected at virologic failure in participants receiving NNRTI and/or PI-based regimens. To evaluate virologic response to a second regimen after NVP or LPV/RTV is changed due to virologic failure as defined above. To evaluate factors (e.g. HIV-1 subtype, disease status) in diverse geographical locations that are associated with risk of virologic failure and antiretroviral drug resistance. To compare changes in CD4+ cell counts and HIV-related disease progression and mortality in each treatment arm. To determine if NVP drug exposure (parent drug) as estimated by pharmacokinetic measurements correlates with development of NVP-associated rash and/or hepatitis. To evaluate adherence to study drug regimens by participant self-report and pill count. To compare resource utilization and quality of life in participants randomized to Arm 1A versus Arm 1B.

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. To evaluate changes in various visual and anatomical outcomes. Proportion of patients who have no fluid on SD-OCT at weeks 12 24 and 52. Mean structural changes of PED on OCT-Angiography. Mean change in visual acuity at weeks 12, 24 and 52 compared to the baseline. Proportion of patients who gain 5, 10 and 15 letters OR with BCVA better than 20/40 at weeks 12, 24 and 52 Mean change in central foveal thickness and volume measured by SD-OCT at weeks 12, 24 and 52 compared to the baseline. Proportion of patients with development of macular atrophy at week 52. The change of retinal function measured by Macular Integrity Assessment (MAIA) at weeks 24 and 52 compared to the baseline. Mean change in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) score between baseline and weeks 24 and 52. Incidence and severity of adverse events over study period.

Secondary Objectives. 1. To determine the levels of mesenchymal ▇▇▇▇▇ cell mobilization (CD34, CD90 and CD 105 expressing cells in peripheral blood and CFU-F) 2. To evaluate liver function after mobilization of stem cells in patients with chronic liver function.

Secondary Objectives. To evaluate the following measures of clinical benefit for TSR-042, bevacizumab, and niraparib in patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 2 prior lines of anticancer therapy, are PARP inhibitor-naïve, and have platinum-resistant but not refractory disease: − Progression-free survival (PFS) − Overall survival (OS) − Duration of response (DOR) − Disease control rate (DCR) • To evaluate safety and tolerability in patients treated with TSR-042, bevacizumab, and niraparib.