TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Three-arm, 16 Week, Adaptive Phase III Clinical Study to Investigate the Efficacy and Safety of LAS41008 vs LASW1835 and vs Placebo in Patients With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to active control and placebo in patients with moderate to severe chronic plaque psoriasis


Options:
A: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)
B: Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Baseline and Week 12)
C: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)
D: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Three-arm, 16 Week, Adaptive Phase III Clinical Study to Investigate the Efficacy and Safety of LAS41008 vs LASW1835 and vs Placebo in Patients With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to active control and placebo in patients with moderate to severe chronic plaque psoriasis


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20]) (Week 24)
B: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
C: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)
D: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Three-arm, 16 Week, Adaptive Phase III Clinical Study to Investigate the Efficacy and Safety of LAS41008 vs LASW1835 and vs Placebo in Patients With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to active control and placebo in patients with moderate to severe chronic plaque psoriasis


Options:
A: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
B: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 (Week 16); Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 (Week 16)
C: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (Weeks 4, 8 12, and 16 (Period B)); Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) (Weeks 4, 8, 12, and 16 (Period B)); Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C)); Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C))
D: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Three-arm, 16 Week, Adaptive Phase III Clinical Study to Investigate the Efficacy and Safety of LAS41008 vs LASW1835 and vs Placebo in Patients With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to active control and placebo in patients with moderate to severe chronic plaque psoriasis


Options:
A: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
B: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)
C: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 (Week 16); Number of Participants Experiencing Adverse Events (Up to 72 weeks); Number of Particpants Discontinuing Study Treatment Due to Adverse Events (Up to 52 weeks)
D: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted locomotor training on motor recovery of lower extremities and walking ability compared with the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients.

72 first-ever stroke patients who could not walk independently (FAC \< 2), and suffered within 6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk independently before stroke attack were excluded.

Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment (NDT) basically. The robotic assisted locomotor training group received additional robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3), Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA), Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles were assessed before, during (2weeks) and after training. And the independent walking ability were followed until 3 months.


Options:
A: change of functional ambulation category point (baseline, during training (2weeks), post training (4weeks) & followed for 2months after training)
B: Motor Control (3 weeks)
C: Change in 10 Meter Walk Test From Baseline in Gait Speed (Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up))
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
Brief Summary: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.


Options:
A: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24)
B: Trough Forced Expiratory Volume at 1 Second (FEV1) (12 weeks)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis) (Week 12)
D: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h)) (baseline (BL), 12 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
Brief Summary: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.


Options:
A: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (12 weeks)
B: Number of Participants With Adverse Events, Serious Adverse Events or Death (52 weeks + Follow-up (Up to Day 394))
C: Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24 (Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29)
D: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h)) (baseline (BL), 12 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Medication Response in Children With Predominately Inattentive Type ADHD
Brief Summary: This study evaluates how children with Attention Deficit Disorder without Hyperactivity (ADD) respond to medication, and if their response is different from children who have problems with both hyperactivity and inattention. In order to do this, children ages 7-11 whose primary difficulty is with attention problems and who have never been on behavioral or psychiatric medications are being recruited. Once enrolled, children will try one week each of 3 different doses of methylphenidate, the most commonly prescribed Attention Deficit, Hyperactivity Disorder (ADHD) medication, as well as placebo. Children will be randomly assigned to one of six possible medication dose and placebo titration schedules, but the study doctor, family, and teacher will not know which dose (if any) children are receiving for a given week. Each week, behavioral and side effect ratings will be completed by both the child's parent and teacher, and the family will meet with the study doctor for a physical examination and to discuss how each week went. Some children will also have neuropsychological testing to determine how methylphenidate influences their working memory, sustained attention, and ability to inhibit (stop) inappropriate responses.

All data will be analyzed to decide which medication dose the child responded to best and further recommendations for treatment will be given. Ultimately, this study aims to improve understanding of how children with ADHD-Primarily Inattentive Type respond to stimulant medications by

* determining whether these children experience a diminished response to methylphenidate compared to children with both hyperactivity and inattention
* determining whether certain genetic and environmental factors play a role in this response.

Findings from this study will be used to help streamline the identification of the most effective doses of medication for children with ADHD-Primarily Inattentive Type.


Options:
A: Clinicians Manuals from Russell A. Barkley as Disruptive Behavior Disorders Rating Scale--Parent Form (Form 4), Disruptive Behavior Disorders Rating Scale--Teacher Form (Form 5) and Clinical Interview--Parent Report Form (Form 6) (1 year)
B: Attention Deficit Hyperactivity Disorder Total Symptom Score (End of placebo dose week, End of low dose week, End of medium dose week , End of high dose week)
C: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (Baseline to Month-2)
D: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
Brief Summary: The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, which in most cases would mean indefinite treatment. In fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving doubts over the need for (indefinite) anticoagulation which exposes these patients to an increased risk of major bleeding events. Concerns over the need for anticoagulant treatment may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and sub-segmental PE seem to have a more benign course than more proximal embolism.

The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of cancer patients.


Options:
A: Overall 3-year mortality (overall 3-years)
B: Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis (one year)
C: Incidence of venous thromboembolism reduction
D: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Robot-Assisted Therapy in Sequential Combination With Constraint-Induced Therapy in Stroke Rehabilitation
Brief Summary: The findings of this project will contribute to the understanding of a comprehensive probe for investigation of the effects of monotherapy versus combination rehabilitation intervention after stroke, including the topics of possible underlying mechanisms of motor recovery as well as the beneficial and adverse effects of intense rehabilitation therapy, prognostic factors of the outcomes, and clinimetric properties of the instruments. The overall findings of this project will be significant in the era of knowledge translation and guide the development of innovative and effective interventions for individualized stroke rehabilitation.


Options:
A: Fugl-Meyer Assessment for Motor Recovery (FM) Scale (6, 12, 24 and 36 weeks minus baseline)
B: Fugl-Meyer Assessment (FMA) (An expected average of 4 weeks)
C: Action Research Arm Test (ARAT) (End of treatment at 8 weeks post enrolment)
D: Wolf Motor Function Test (8 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Robot-Assisted Therapy in Sequential Combination With Constraint-Induced Therapy in Stroke Rehabilitation
Brief Summary: The findings of this project will contribute to the understanding of a comprehensive probe for investigation of the effects of monotherapy versus combination rehabilitation intervention after stroke, including the topics of possible underlying mechanisms of motor recovery as well as the beneficial and adverse effects of intense rehabilitation therapy, prognostic factors of the outcomes, and clinimetric properties of the instruments. The overall findings of this project will be significant in the era of knowledge translation and guide the development of innovative and effective interventions for individualized stroke rehabilitation.


Options:
A: Motor Control (3 weeks)
B: Change in 10 Meter Walk Test From Baseline in Gait Speed (Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up))
C: Peak Oxygen Uptake (V'O2peak) (4 weeks)
D: Fugl-Meyer Assessment (FMA) (An expected average of 4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Robot-Assisted Therapy in Sequential Combination With Constraint-Induced Therapy in Stroke Rehabilitation
Brief Summary: The findings of this project will contribute to the understanding of a comprehensive probe for investigation of the effects of monotherapy versus combination rehabilitation intervention after stroke, including the topics of possible underlying mechanisms of motor recovery as well as the beneficial and adverse effects of intense rehabilitation therapy, prognostic factors of the outcomes, and clinimetric properties of the instruments. The overall findings of this project will be significant in the era of knowledge translation and guide the development of innovative and effective interventions for individualized stroke rehabilitation.


Options:
A: Fugl-Meyer Score Change Immediately Following Study Intervention. (After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.); Fugl-Meyer Score Change at 6 Months (FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.)
B: Movement time (Baseline and change from baseline in movement time at 4 weeks); Motor units (Baseline and change from baseline in motor units at 4 weeks); Elbow extension angle (Baseline and change from baseline in elbow extension angle at 4 weeks); Lateral index (Baseline and change from baseline in lateral index at 4 weeks)
C: Fugl Meyer Assessment Scale (four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up)
D: Fugl-Meyer Assessment (FMA) (An expected average of 4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
Brief Summary: To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.


Options:
A: Psychological symptoms (Change from baseline to after treatment (6-9 weeks), 3 and 12 months)
B: Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 (At Baseline and Week 12.)
C: Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] (12 weeks)
D: Montgomery Asberg Depression Rating Scale (MADRS) (Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: LungVITamin D and OmegA-3 Trial
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.


Options:
A: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)
B: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
C: Sudden cardiac death (12 months)
D: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: LungVITamin D and OmegA-3 Trial
Brief Summary: The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.


Options:
A: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)
B: Treatment Failure (Twenty-eight week intervention period from randomization until end of trial.)
C: serum Vitamin D (3 months)
D: Mean Annual Rate of Respiratory Events (Up to 2 years)

Answer: A