TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis
Brief Summary: This is a is a small scale open phase two interventional study to assess long-term stabilising effects of on neurological symptoms by regular intrathecal administered monoclonal antibodies in progressive multiple sclerosis.


Options:
A: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.
B: Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab (Up to 10 months); Percentage of Participants Using Rituximab Off-Label (Up to 10 months)
C: Number of participants with adverse events (One year after completed treatment)
D: Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months); Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention
Brief Summary: The investigators hypothesized that sleeping in a 45 degrees elevated body position decreases the likelihood of upper airway vulnerability to collapse early after delivery. Furthermore, the investigators want to elucidate the anatomical and physiological risk factors that contribute in the upper airway obstruction in post-partum patients.


Options:
A: Neurologic recovering; Quality of life; Recurrences
B: Efficacy in reducing the mean AHI (12 months)
C: Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep (48 hours after delivery)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study
Brief Summary: This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.


Options:
A: Forced expiratory volume in 1-second (FEV1) compared to active comparator (Year 1); Quality of Life (SGRQ) (Year 1)
B: Reduction in gas trapping (12 weeks post treatment); SAEs - Safety of treatment and the procedure (2 years post treatment)
C: Quantitative change of lung volume on computed tomography (Before procedure and 12 weeks after procedure)
D: 6-month improvement of the 6-minute walk test (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study
Brief Summary: This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.


Options:
A: Pulmonary function testing at various time points through one year; Exercise tolerance at various time points through one year; Major complications at various time points through one year
B: Forced expiratory volume in 1-second (FEV1) compared to active comparator (Year 1); Quality of Life (SGRQ) (Year 1)
C: Reduction in gas trapping (12 weeks post treatment); SAEs - Safety of treatment and the procedure (2 years)
D: Reduction in gas trapping (12 weeks post treatment); SAEs - Safety of treatment and the procedure (2 years post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL
Brief Summary: The purpose of this study is to compare the efficacy of graded activity program and supervised exercise on pain, functional disability, quality of life, global perceived effect, return to work, physical activity, physical capacity and strength of the lower limbs in patients with chronic non-specific low back pain


Options:
A: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)
B: Pain VAS
C: Pain (6 weeks); Functional Disability (6 weeks)
D: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL
Brief Summary: The purpose of this study is to compare the efficacy of graded activity program and supervised exercise on pain, functional disability, quality of life, global perceived effect, return to work, physical activity, physical capacity and strength of the lower limbs in patients with chronic non-specific low back pain


Options:
A: Muscle activity onset in transversus abdominal muscle (1 year)
B: Pain (6 weeks); Functional Disability (6 weeks)
C: Pain VAS
D: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
Brief Summary: The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.


Options:
A: Overall Survival Time (OS) (Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007)
B: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
C: Progression Free Survival (12 months)
D: Progression free survival (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychoeducation of Borderline Patients
Brief Summary: Recent research suggests that BPD is a common, serious but treatable disorder with a better than previously recognized prognosis. Despite these findings, many patients with BPD are not given the borderline diagnosis by the mental health professionals treating them. It is also true that many newly diagnosed borderline patients are not provided with up-to-date information on the disorder even though psychoeducation has been found to be a useful form of treatment for other serious psychiatric illnesses.

The investigators have conducted a preliminary randomized trial of psychoeducation for BPD that found that those provided with immediate psychoeducation had a significantly greater reduction in two core symptoms of BPD--general impulsivity and stormy relationships--than those with delayed psychoeducation.

However, both instruction and assessment of change over time were conducted in person by paraprofessionals. The importance of the current study is that it will allow the investigators to develop and test the efficacy of an internet-based program of psychoeducation for BPD that will be both cost efficient and easy to disseminate widely, particularly to underserved populations.


Options:
A: Acceptability of the intervention assessed by the number of therapy sessions completed by participants in the intervention arm. (2 years); Incidence of Treatment-Emergent Adverse Events as assessed by the adverse experiences in psychotherapy self-reported measure (2 years); Feasibility of the intervention assessed by the number of assessments completed by participants in the intervention arm (2 years)
B: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
C: Zanarini Rating Scale for Borderline Personality Disorder (Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up)
D: Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Service Utilization at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Suicidality at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychoeducation of Borderline Patients
Brief Summary: Recent research suggests that BPD is a common, serious but treatable disorder with a better than previously recognized prognosis. Despite these findings, many patients with BPD are not given the borderline diagnosis by the mental health professionals treating them. It is also true that many newly diagnosed borderline patients are not provided with up-to-date information on the disorder even though psychoeducation has been found to be a useful form of treatment for other serious psychiatric illnesses.

The investigators have conducted a preliminary randomized trial of psychoeducation for BPD that found that those provided with immediate psychoeducation had a significantly greater reduction in two core symptoms of BPD--general impulsivity and stormy relationships--than those with delayed psychoeducation.

However, both instruction and assessment of change over time were conducted in person by paraprofessionals. The importance of the current study is that it will allow the investigators to develop and test the efficacy of an internet-based program of psychoeducation for BPD that will be both cost efficient and easy to disseminate widely, particularly to underserved populations.


Options:
A: Zanarini Rating Scale for Borderline Personality Disorder (Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up)
B: MHS heavy use (2 years)
C: Borderline Symptom Checklist (BSL-23) (Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment)
D: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychoeducation of Borderline Patients
Brief Summary: Recent research suggests that BPD is a common, serious but treatable disorder with a better than previously recognized prognosis. Despite these findings, many patients with BPD are not given the borderline diagnosis by the mental health professionals treating them. It is also true that many newly diagnosed borderline patients are not provided with up-to-date information on the disorder even though psychoeducation has been found to be a useful form of treatment for other serious psychiatric illnesses.

The investigators have conducted a preliminary randomized trial of psychoeducation for BPD that found that those provided with immediate psychoeducation had a significantly greater reduction in two core symptoms of BPD--general impulsivity and stormy relationships--than those with delayed psychoeducation.

However, both instruction and assessment of change over time were conducted in person by paraprofessionals. The importance of the current study is that it will allow the investigators to develop and test the efficacy of an internet-based program of psychoeducation for BPD that will be both cost efficient and easy to disseminate widely, particularly to underserved populations.


Options:
A: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
B: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)
C: MHS heavy use (2 years)
D: Zanarini Rating Scale for Borderline Personality Disorder (Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychoeducation of Borderline Patients
Brief Summary: Recent research suggests that BPD is a common, serious but treatable disorder with a better than previously recognized prognosis. Despite these findings, many patients with BPD are not given the borderline diagnosis by the mental health professionals treating them. It is also true that many newly diagnosed borderline patients are not provided with up-to-date information on the disorder even though psychoeducation has been found to be a useful form of treatment for other serious psychiatric illnesses.

The investigators have conducted a preliminary randomized trial of psychoeducation for BPD that found that those provided with immediate psychoeducation had a significantly greater reduction in two core symptoms of BPD--general impulsivity and stormy relationships--than those with delayed psychoeducation.

However, both instruction and assessment of change over time were conducted in person by paraprofessionals. The importance of the current study is that it will allow the investigators to develop and test the efficacy of an internet-based program of psychoeducation for BPD that will be both cost efficient and easy to disseminate widely, particularly to underserved populations.


Options:
A: Zanarini Rating Scale for Borderline Personality Disorder (Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up)
B: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (one year); Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) (one year); Coping Styles and Strategies Scale (COPE) (Crespo 1997) (one year)
C: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)
D: Borderline Symptoms (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Brief Summary: Patients with chronic lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), who perform regular physical activity, have improved health and wellbeing compared with those who do little exercise. The purpose of the study is to evaluate whether the use of a simple pedometer (step counter) to set targets for daily physical activity can encourage COPD patients referred for an 8-week pulmonary exercise based programme (PR) to be more active. The investigators also want to know whether the use of pedometers during PR can improve adherence, self-management and outcome in COPD.


Options:
A: Feasibility of tai chi intervention (24 weeks)
B: Walking time in daily life and the amount of time spent in moderate intense activities
C: Change from baseline of time spent in at least moderate physical activity (3>METS equivalent) (8 weeks)
D: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a Intrapatient Dose Escalation Study of Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors
Brief Summary: Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer (SCLC) and other high-grade neuroendocrine tumors.


Options:
A: Overall Response Rate (ORR) (6 weeks)
B: Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 (Up to 2 weeks)
C: serial dexamethasone/CRH tests (week 0, 1, and 5)
D: Hot Flash Symptom Severity Score (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims
Brief Summary: The recent dramatic increase in obesity has been linked to a reduction of dietary fibre intake. We hypothesized that supplementing the diet of overweight and obesity adults with pulse fibre will improve their metabolic status, chiefly defined as greater weight loss. Other metabolic health improvements may include improved glucose control and reduced inflammatory markers.


Options:
A: Primary Outcome Measures Described Below (December 2011)
B: Oxidized LDL (After 4 and 6 weeks)
C: weight loss (12 weeks)
D: Change in Fat Mass at 12 Weeks (Value at 12 weeks minus value at baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pragmatic Evaluation of Case Management and Self-management Support for Vulnerable People With Chronic Diseases in Primary Care
Brief Summary: The purpose of this study is to implement a pragmatic intervention in four (4) family medicine groups(FMGs) in the region of Saguenay-Lac-Saint-Jean (Quebec, Canada)for patients with chronic diseases.


Options:
A: Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events (48 months + 36 month extension)
B: Change in patient perception of personal self-efficacy at 6 months (6 months); Change in patient perception of self-management practice at 6 months (6 months); Change in patient perception of health behaviours at 6 months (6 months); Change in patient perception of activation at 6 month (6 months); Change in patient perception of psychological distress at 6 months (6 months)
C: Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL (12 months)
D: Prevalence of latent heart failure and COPD. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pragmatic Evaluation of Case Management and Self-management Support for Vulnerable People With Chronic Diseases in Primary Care
Brief Summary: The purpose of this study is to implement a pragmatic intervention in four (4) family medicine groups(FMGs) in the region of Saguenay-Lac-Saint-Jean (Quebec, Canada)for patients with chronic diseases.


Options:
A: Comorbidities treatment (6 months later); Auto-DAS: Patient education to calculate his Disease Activity Score (6 months after)
B: Change in patient perception of personal self-efficacy at 6 months (6 months); Change in patient perception of self-management practice at 6 months (6 months); Change in patient perception of health behaviours at 6 months (6 months); Change in patient perception of activation at 6 month (6 months); Change in patient perception of psychological distress at 6 months (6 months)
C: Prevalence of latent heart failure and COPD. (6 months)
D: The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face
Brief Summary: Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10 mm) excision for a localized tumor on the face.

Several studies have shown that imiquimod, activating local immunity by interferon production, induced LM or MLM regression and could also decrease the frequency of relapses.

The principal aim of our project is to study the effect of imiquimod versus placebo in pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the first surgical procedure, and the frequency of short and medium term recurrence of LM. Furthermore, the improvement in patient quality of life could also be significant.


Options:
A: The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm. (10 weeks)
B: Progression-free Survival (PFS) as Assessed by the Investigator (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)); Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months))
C: Recurrence-Free Survival (RFS) (24 months after last participant was randomized (data cutoff date of 30 April 2019))
D: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants (From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months))

Answer: A