TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer
Brief Summary: RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer.

PURPOSE: This randomized phase III trial is studying active monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.


Options:
A: Interval before biochemical failure (10 years)
B: Five-year Disease-free Survival (DFS) Rate (Analysis occurs after all patients have been followed for five years.)
C: Disease specific mortality (Median 15 years follow up)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer
Brief Summary: RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer.

PURPOSE: This randomized phase III trial is studying active monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.


Options:
A: Overall Survival (From randomization (Day 1) up to end of study (Month 60)); Radiographic Progression-free Survival (rPFS) (From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18))
B: Disease specific mortality (Median 15 years follow up)
C: Survival (7.5 years after the first inclusion); Survival (9.5 years after the first inclusion)
D: Overall Survival (Up to 60 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Multicenter, Double-blind, Randomized, Placebo-controlled Parallel-group Phase 2 Dose Selection Study of Lorcaserin Hydrochloride, an Oral 5-HT2C Receptor Agonist for Smoking Cessation
Brief Summary: In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12). The target quit date was Day 15.


Options:
A: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
B: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
C: Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 (Week 9 - Week 12)
D: Continuous smoking abstinence rate (Weeks 9 to 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial
Brief Summary: The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program.

The secondary objectives are the following:

* assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
* assess the improvement of exercise capacity by tests used in medical practice
* assess the correlation between daily activity and exercise capacity
* assess the improvement of dyspnea
* assess the improvement of quality of life and psychological state


Options:
A: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks. (52 weeks)
B: changes in six minute walking distance after 6 months (6 months)
C: Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET) (12 months)
D: Annual Rate of Decline in Forced Vital Capacity - Overall Population (Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)); Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only (Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pragmatic Randomized Trial to Investigate the Effectiveness of BehaviouRal ActiVation Group Therapy in Reducing dEpressive Symptoms and Improving Quality of Life in Patients With Depression: BRAVE Pilot Study
Brief Summary: The study's primary goal is to assess the effectiveness of behavioural activation in reducing depressive symptoms and re-integrate patients with depression into their personal and professional lives thus improving quality of life and helping in attaining and maintaining remission of depression. It is aimed at helping patients re-engage with several life areas that they may have lost in the course of depressive illness. The intervention is centred on behavioural activation (BA) with complementary interventions including recreation activities, and behavioural modifications. The study question is: in patients with depressive disorder attending a specialized hospital based mood disorders clinic, does the addition of behavioural activation program delivered in a group format improve depressive symptoms and quality of life compared to treatment as usual after 18 weeks of treatment? Study investigators hypothesize that behavioural activation is an effective treatment for depressive disorder in patients with depression.


Options:
A: Depressive Symptoms - Beck Depression Inventory (BDI-II) (Immediately upon completion of 8 week intervention)
B: PHQ9 Depression Score (3 months post-partm)
C: Recruitment and retention rates, data completion, and resource utilization. (Baseline, Week 18)
D: Beck Depression Inventory- II (Assessed at every session and at the 1-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Surgical Pleth Index - Relevance in Small Children. A Randomised Double Blinded Study
Brief Summary: Surgical Pleth index is a novel device aimed for measurement of intraoperative nosiseption. It has not been tested on small children. The aim of this study is to measure, whether there is a difference in nosiception measured by SPI in a group receiving local anesthetics prior to operation compared to group receiving plasebo.


Options:
A: Surgical Pleth Index (SPI) at the time of start of surgery (intraoperative)
B: time to first use of analgesic (24 hour)
C: Narcotic requirement (24 hours post intervention)
D: postoperative pain (from emergence to 24 hrs post-discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older
Brief Summary: The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax 23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™ vaccine immune response will also be evaluated.


Options:
A: Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))
B: Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group (At 1 month post-Dose 2 (Month 3)); Antibody Concentrations Against Glycoprotein E (Anti-gE) (At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)); Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens (At 1 month post-Dose 1 (Month 1)); Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens (At 1 month post-Dose 1 (Month 1))
C: Number of Subjects With a Vaccine Response for Anti-gE Antibodies (At Month 3); Anti-glicoprotein E (gE) Antibody Concentrations (At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)); Anti-pneumococcal Antibody Titers (At one month post-dose (Month 1)); Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups (At 1 month after vaccination); Adjusted GMCs Between Groups (At 1 month after last vaccine dose)
D: GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) (6 weeks after IP(Investigational Product) vaccination); GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA (6 weeks after IP(Investigational Product) vaccination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older
Brief Summary: The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax 23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™ vaccine immune response will also be evaluated.


Options:
A: Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))
B: Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Anti-glycoprotein E (gE) Antibody Concentrations (One month after the second vaccination (Month 3)); Anti-VZV Antibody Concentrations (One month after the second vaccination (Month 3))
C: Number of Subjects With Any Episodes of Herpes Zoster (HZ) (During the entire study period (3 to 5 year period following Day 0)); Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) (During the entire study period (3 to 5 year period following Day 0)); Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ (During the entire study period (3 to 5 year period following Day 0))
D: Number of Subjects With a Vaccine Response for Anti-gE Antibodies (At Month 3); Anti-glicoprotein E (gE) Antibody Concentrations (At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)); Anti-pneumococcal Antibody Titers (At one month post-dose (Month 1)); Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups (At 1 month after vaccination); Adjusted GMCs Between Groups (At 1 month after last vaccine dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Brief Summary: The goal of this study is to gather input from patients who have undergone PCI, their family and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the decision aid is to deliver information, including individualized estimates of patients' restenosis risk, in an understandable format that would be informative and assist in decision-making for patients undergoing PCI.


Options:
A: Patient Adherence (Test Completion) (12 months post-intervention)
B: Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching (30 months)
C: Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling (6 &12-month follow-up)
D: The number of eligible patients that can be identified who receive the uterine fibroid Option Grid patient decision aid. (Month 1-14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
Brief Summary: Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. It works by heating and thereby obliterating the vein. Steam ablation is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).


Options:
A: Obliteration of varicose vein and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the great saphenous vein (GSV) at 12 and 52 weeks. (52 weeks)
B: Intra-procedural Pain (Up to end of intervention); Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. (At 1 year)
C: Generic Quality of life - Short Form-36 (1 week, 6 weeks, 3 months, 1 year, 2 years)
D: Change in intensity of hyper pigmentation using a scale of 0 to 10 (One week, one month and six months after surgery); Change in extension of hematoma using a scale of 0 to 10 (One week, one month and six months after surgery); Change in aesthetic results using a scale of 0 to 10 (One week, one month and six months after surgery); Change in pain levels using a scale of 0 to 10 (One week, one month and six months after surgery); Change in intensity of skin burns using a scale of 0 to 10 (One week, one month and six months after surgery); Change in presence of sensitivity alteration (One week, one month and six months after surgery); Change in presence of thrombophlebitis (One week, one month and six months after surgery); Change in presence of resection or occlusion of the great saphenous vein (One month, six months and 12 months after surgery); Change in presence of reflux in the sapheno-femoral junction and in the great saphenous vein (One month, six months and 12 months after surgery); Change in presence of complications (One month, six months and 12 months after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial
Brief Summary: A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI).


Options:
A: Difference in Incontinence Impact Questionnaire (IIQ-7) scores (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Difference in Overactive Bladder Symptom Score (OABSS) (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Urogenital Distress Inventory (UDI-6) scores (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Differences in daytime frequency (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); incontinence episodes (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Nocturia (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group)
B: Change in number of micturition episodes per 24 hours (Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up))
C: Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 (baseline, weeks 1-12)
D: Stress test (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial
Brief Summary: A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI).


Options:
A: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
B: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)
C: Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 (baseline, weeks 1-12)
D: UI incidence/severity (12 months - 3 years post-index birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
Brief Summary: Musculoskeletal disorders and stress of employees remain a major problem in many occupations. The aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical exercises (reference group) on musculoskeletal pain, work disability, and stress in lab technicians with a history of work-related musculoskeletal pain.


Options:
A: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)
B: Pain intensity (change from baseline to week 10)
C: Percentage of patients with recurrence(s) of lower back pain (number of related days of sick leave) over 12 months and 24 months (12 and 24 months)
D: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients
Brief Summary: This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.

The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).


Options:
A: Change from baseline in the total area of the GA lesion(s) (24 months)
B: N/A
C: N/A
D: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 (At the end of month 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients
Brief Summary: This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.

The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).


Options:
A: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 (At the end of month 24)
B: 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.
C: Number of Participants With Treatment-emergent Adverse Events (AEs) (Up to 72 weeks); Number of Participants With Abnormalities in Vital Signs (Up to Week 72); Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities (Up to 72 Weeks); Number of Participants With Abnormalities in Blood Chemistry Laboratory Data (Up to 72 Weeks); Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline (Up to 72 weeks)
D: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing Traditional and Participatory Dissemination of a Shared Decision Making Intervention
Brief Summary: Asthma is a common disease that affects people of all ages and has significant morbidity and mortality. Poor outcomes and health disparities related to asthma result in part from the difficulty of disseminating new evidence and paradigms of care delivery such as shared decision making (SDM) into clinical practice. This study will evaluate a novel mechanism for dissemination of an evidence-based SDM Toolkit for asthma care in primary care practices. The study is ideally suited to study dissemination methods because it will leverage a partnership between an established consortium of practice based research networks (PBRNs) and an advanced Medicaid Network.

This study will evaluate a novel dissemination process (FLOW) to spread an Asthma Shared Decision Making Toolkit to practices within a Medicaid network using a consortium of practice-based research networks (NCNC). The knowledge gained from this proposal and the partnerships formed between practice-based research networks and NC Medicaid will facilitate widespread dissemination to almost 300 practices.


Options:
A: Change from baseline in asthma knowledge at 2 months, measured by QCALF score (Visit 1 (baseline) and visit 2 (2-month follow-up)); Change from baseline in decisional conflict at 2 months, measured by DCS score (Visit 1 (baseline) and visit 2 (2-month follow-up))
B: N/A
C: Patient Perception of Shared Decision Making (18 months)
D: N/A

Answer: C