TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)
Brief Summary: Primary Objective:

To evaluate long-term safety of alemtuzumab.

Secondary Objectives:

* To evaluate long term efficacy of alemtuzumab.
* To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment.
* To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab.
* To evaluate as needed re-treatment with alemtuzumab and other DMTs.


Options:
A: Number of Days Until First On-study Relapse (12 months)
B: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)
C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) (From Baseline until the end of the study (up to a maximum duration of 5.6 years)); Number of Participants With Infusion-Associated Reactions (IAR) (Within 24 hours of any alemtuzumab infusion); Number of Participants With Adverse Events of Special Interest (AESI) (From Baseline until the end of the study (up to a maximum duration of 5.6 years)); Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (From Baseline until the end of the study (up to a maximum duration of 5.6 years))
D: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (Throughout study); Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (At Months 3, 6, and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study DB2116961, A Multicentre, Randomised, Blinded, Parallel Group Study to Compare UMEC/VI (Umeclidinium/Vilanterol) in a Fixed Dose Combination With Indacaterol Plus Tiotropium in Symptomatic Subjects With Moderate to Very Severe COPD
Brief Summary: This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram \[mcg\] Once daily \[QD\]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH \& Co. KG. BREEZHALER is a registered trademark of Novartis AG.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1). (12 weeks)
B: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8) (Baseline (BL) and Day 85)
C: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
D: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (after 12 weeks of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acceptability of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia
Brief Summary: The purpose of this trial is to evaluate the acceptability of the LNS to women and their children aged 12-17 months in comparison to Corn Soy Blend++, and Sprinkles added to borbor (white rice porridge, which is the traditional weaning food in Cambodia). Acceptability will be assessed through a sensory test for caregivers, and by measuring children's consumption.


Options:
A: Child's consumption (Within 15 minutes)
B: Change in prevalence of growth faltering during the intervention (end of intervention (approximately 12 months of age)); Change in prevalence of growth faltering post-intervention (Six-months post-intervention (approximately 18 months of age))
C: Infant length at 18 months (18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy.); Infant hemoglobin at 18 months (18 months)
D: Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age (After 24 months of program implementation); Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months) (monthly from study inclusion at 6 months to 23 months of age and at study endline); Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm (Monthly from study inclusion at 6 months to 23 months of age); Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted) (monthly from study inclusion at 6 months to 23 months of age and at study endline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The ability to control our blood glucose (sugar) concentrations after a meal is a strong predictor of the risk of disease. Our bodies respond to glucose ingestion by reducing the amount of glucose from the liver entering the bloodstream. At the same time muscle increases the amount of glucose it take up from the bloodstream. This ensures that our blood glucose levels do not get too high. The investigators want to understand what happens to these processes following exercise after breakfast and after an overnight fast. In addition, the investigators also want to understand whether exercising with or without breakfast influences our appetite, food intake and activity levels later in the day.


Options:
A: Exogenous glucose appearance rate (120 minutes); Energy balance (24 hours)
B: Postprandial Glucose Response (12 weeks)
C: Fat loss and lean mass retention (14 weeks); Weight loss (14 weeks); Absolute changes in body composition (14 weeks)
D: Change in Total Body Weight (in kg) at 3 months compared to baseline (Baseline to 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)
Brief Summary: The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.


Options:
A: Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108)
B: Number of severe asthma patients eligible for one or more biologic treatments for asthma (Day 1)
C: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35)
D: adenosine, PC20, forced expiratory volume in one second (FEV1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Brief Summary: This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.


Options:
A: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)
B: Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose (Day 43, 60 minutes post-dose after 6 weeks of each treatment)
C: The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization (Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days))
D: Combined number of hospitalizations and emergency department presentations (Two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Brief Summary: This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.


Options:
A: Combined number of hospitalizations and emergency department presentations (Two years)
B: Patient Health Questionnaire -9 (PHQ-9) (4 month (post treatment), 8 month follow/up, and 12 month follow/up); Beck Anxiety Inventory (BAI) (4 month (post treatment), 8 month follow/up, and 12 month follow/up); Chronic Respiratory Questionnaire_Fatigue (4 month (post treatment), 8 month follow/up, 12 month follow/up); Chronic Respiratory Questionnaire_Mastery (4 month (post treatment), 8 month follow/up, 12 month follow/up); Chronic Respiratory Questionnaire_Dyspnea (4 month (post treatment), 8 month follow/up, 12 month follow/up); Kansas City Cardiomyopathy Questionnaire (KCCQ) (4 month (post treatment), 8 month follow/up, and 12 month follow/up)
C: Change in HADS-A score from baseline to three months follow-up (Three months)
D: Daily number of steps (changes from baseline to 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Brief Summary: This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.


Options:
A: Improvement tolerance capacity (4 months and 6 months)
B: Steps per day as mean over one week from baseline until the treatment end (Every day for 6 months)
C: Quadriceps Muscle Strength Testing Change (measured at baseline and at ten weeks); Six Minute Walk Test (measured at baseline and at ten weeks); Health-related Quality of Life Assessments Change (measured at baseline and ten weeks); Participant Satisfaction Survey (measured at ten weeks (study completion))
D: Combined number of hospitalizations and emergency department presentations (Two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Brief Summary: This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.


Options:
A: Combined number of hospitalizations and emergency department presentations (Two years)
B: Number of hospitalizations due to exacerbation of COPD avoided (1 year)
C: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
D: Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge (6 months post-discharge from hospitalization following COPD exacerbation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Brief Summary: This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.


Options:
A: ADEs (Measured 30 and 90 days after hospital discharge); Medication appropriateness (Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index); Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE (Measured 30 and 90 days after hospital discharge); Cost-effectiveness of the minimal or enhanced treatment compared to usual care (Measured 30 and 90 days after hospital discharge)
B: 30 day readmission rate (30 days)
C: Combined number of hospitalizations and emergency department presentations (Two years)
D: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Brief Summary: This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.


Options:
A: The number of ED presentations (1 year after randomization.)
B: Combined number of hospitalizations and emergency department presentations (Two years)
C: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. (4 years)
D: COPD Assessment Test (CAT) (Baseline and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SIgns and Symptoms Self-Monitoring and Psychoeducation in bipoLar Patients With a Smart-phonE Application (SIMPLE)
Brief Summary: Bipolar disorder is a frequent condition in the general population with a high morbimortality, which consists in dysfunctional temporal fluctuations between different mood phases ranging from depression to manic episodes with frequent subsyndromal symptoms between them. Usually during these phases, the subjects have a lack of insight about the diagnosis and symptoms. Besides the pharmacological treatment, additional psychological interventions have shown to improve the long-term outcome of the disorder, yet taking into account the limited resources currently available, its general implementation is still difficult and costly. Among these interventions, group psychoeducational programs have proved to be cost-effective in helping patients recognize early signs and symptoms in order to prevent full blown episodes which very usually are associated with a high morbidity and hospital admissions.

On the other hand, numerous projects have tested the potential benefits of new technologies such internet in the treatment of bipolar and psychotic disorders patients using either online signs and symptoms monitoring or web-based psychoeducational programs, yet to the investigators knowledge, none of them have integrated both approaches in one single intervention.

The hypothesis that, combining both interventions (signs and symptoms monitoring along with psychoeducational contents) in a single smart-phone application will prove to be at least equal or superior in terms of efficacy comparing to the standard treatment, seems promising, given the fact that both approaches have independently demonstrated their efficacy in the same population. This could extend the range of the patients in whom this kind of additional interventions could be implemented; preventing relapses, suicide attempts, consultations and hospitalizations at a much lower cost.


Options:
A: Number of relapses during intervention (During the entire 6 months study period)
B: Depressive symptoms reduction (Measured at months 6 and 12)
C: Change in PTSD Symptom Severity (PDS) (Baseline, 6 months)
D: Hemoglobin A1c (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Noninvasive Ventilation Strategies for Early Treatment of RDS in Preterm Infants: An RCT
Brief Summary: The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respiratory distress syndrome (RDS).


Options:
A: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))
B: Extubation failure (apnea rate and respiratory failure.)
C: The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. (1 year)
D: Duration of NIV Support (10 days); Failure of NIV Support (10 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Noninvasive Ventilation Strategies for Early Treatment of RDS in Preterm Infants: An RCT
Brief Summary: The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respiratory distress syndrome (RDS).


Options:
A: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)
B: The rate of successful extubation with either mode of NCPAP (Day 7 post primary extubation)
C: Duration of NIV Support (10 days); Failure of NIV Support (10 days)
D: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Brief Summary: The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.


Options:
A: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF) (Baseline to Week 12)
B: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 (Baseline to Week 16)
C: stable remission in both treatment groups
D: Change in EASI Scores (Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm))

Answer: B