TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind, Multinational, Multicentre, Parallel-group, Placebo-controlled Design Trial of the Efficacy and Safety of Nebulised Beclometahsone Dipropionate (400 μg b.i.d.) Plus as Needed Salbutamol Versus as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination, in the 12-week Treatment of Young Children With Asthma Symptoms
Brief Summary: To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation, compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young children with persistent symptoms of asthma.


Options:
A: symptom free days; days with no use of bronchodilator; days with no use of bronchodilator and no symptoms; number of treated episodes; number of treatment with add-on medication
B: Rate of Exacerbations Requiring Systemic Corticosteroids (Measured during the 12-month follow-up period)
C: The primary outcome for comparison across treatment groups was the mean value of morning PEF measured during the last 2 weeks of treatment (weeks 23-24)
D: Percentage of global (weeks 1-12) symptom-free days. (weeks 1-12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia
Brief Summary: There are evidences of functional growth hormone (GH) deficiency, expressed by means of low serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients. The efficacy of low GH doses versus placebo has been demonstrated in this population. We assessed the efficacy and safety of GH added to standard therapy compared to standard therapy alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low IGF-1 levels.


Options:
A: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
B: reduction number of tender points (paired) (one year treatment)
C: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
D: Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire (Baseline, 6, 12, 18 and 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia
Brief Summary: There are evidences of functional growth hormone (GH) deficiency, expressed by means of low serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients. The efficacy of low GH doses versus placebo has been demonstrated in this population. We assessed the efficacy and safety of GH added to standard therapy compared to standard therapy alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low IGF-1 levels.


Options:
A: Overall impact of fibromyalgia (Participants will be followed over 24 weeks)
B: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
C: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)
D: reduction number of tender points (paired) (one year treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeted Pharmacologic Interventions for Autism: A Double-Blind, Placebo-Controlled Trial of Atomoxetine in Children and Adolescents With Autism
Brief Summary: This study will evaluate the effectiveness of atomoxetine in treating children with attention deficit hyperactivity disorder symptoms associated with autistic disorder, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified.


Options:
A: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) (8 weeks)
B: Clinical Global Impression - Severity (Week 12); Clinical Global Impression - Improvement (Week 12)
C: Change from baseline Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD) score, at three months. Within subject difference between the placebo condition and the whole plant extract condition. (At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period)); Clinical Global Impression-Improvement scores (CGI-I ) at three months. Within subject difference between the placebo condition and the whole plant extract condition. (At 3 months (end of treatment period))
D: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeted Pharmacologic Interventions for Autism: A Double-Blind, Placebo-Controlled Trial of Atomoxetine in Children and Adolescents With Autism
Brief Summary: This study will evaluate the effectiveness of atomoxetine in treating children with attention deficit hyperactivity disorder symptoms associated with autistic disorder, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified.


Options:
A: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) (8 weeks)
B: Mean Conners' Teacher ADHD Index T Score by Dose (Measured at each dosing week of the drug trial (placebo, low, medium, high)); Mean Continuous Performance Test (CPT)-Commission Errors by Dose (Measured at each dosing week of the drug trial (placebo, low, medium, high))
C: Rate of Recruitment (19 months)
D: Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks (baseline to 10 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeted Pharmacologic Interventions for Autism: A Double-Blind, Placebo-Controlled Trial of Atomoxetine in Children and Adolescents With Autism
Brief Summary: This study will evaluate the effectiveness of atomoxetine in treating children with attention deficit hyperactivity disorder symptoms associated with autistic disorder, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified.


Options:
A: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) (8 weeks)
B: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain (16 weeks)
C: N/A
D: Change From Baseline in Social Communication Deficits as Measured by Social Responsiveness Scale 2 (SRS-2) (Baseline, Week 12); Percentage of Participants with Suicidality, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline up to Week 12); Percentage of Participants With Adverse Events (From Baseline up to Week 18)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Study of Gemcitabine Versus TS-1 Versus Gemcitabine Plus TS-1 in Unresectable Advanced Pancreatic Cancer (With Local Progression or Metastasis)
Brief Summary: In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using survival time.


Options:
A: Overall Survival (From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months))
B: Over all survival(OS) (every course for first three courses, then every other course)
C: TTF2 (approximate 6 months after first line treatment)
D: Overall survival (A subject's survival time will be defined as the time from randomization to the date of his or her death. If the subject has not died, survival will be censored on last date the subject was known to be alive.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial
Brief Summary: Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment.

The purpose of this study is to determine whether a supervised resistance muscular exercise (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain.

The practical of the RME reduces the pain of participants with FMS.


Options:
A: Pain (10 sessions, in 5 weeks, 2 times a week)
B: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
C: Overall impact of fibromyalgia (Participants will be followed over 24 weeks)
D: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial
Brief Summary: Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment.

The purpose of this study is to determine whether a supervised resistance muscular exercise (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain.

The practical of the RME reduces the pain of participants with FMS.


Options:
A: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
D: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial
Brief Summary: Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment.

The purpose of this study is to determine whether a supervised resistance muscular exercise (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain.

The practical of the RME reduces the pain of participants with FMS.


Options:
A: Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks (Week 0, Week 24)
B: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
C: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
D: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial
Brief Summary: Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment.

The purpose of this study is to determine whether a supervised resistance muscular exercise (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain.

The practical of the RME reduces the pain of participants with FMS.


Options:
A: Ambulatory Pain (Higher Values Indicate Greater Pain) (Baseline and after 12-weeks); Ambulatory Fatigue, Higher Values Indicate Greater Fatigue (Baseline and after 12-weeks)
B: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
C: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)
D: Pain severity (Week 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial
Brief Summary: Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment.

The purpose of this study is to determine whether a supervised resistance muscular exercise (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain.

The practical of the RME reduces the pain of participants with FMS.


Options:
A: Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) (6 months)
B: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
C: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
D: Overall impact of fibromyalgia (Participants will be followed over 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis
Brief Summary: * PHASE: II
* TYPE OF STUDY : With direct benefit
* DESCRIPTIVE: Multicenter, randomized, double-blind study
* INCLUSION CRITERIA: Steroid-dependent ulcerative colitis
* OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free remission in steroid-dependent ulcerative colitis
* STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1 intramuscular injection per week
* NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients
* INCLUSION PERIOD: 24 months
* STUDY DURATION: 36 months
* EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without colectomy at 16 weeks of treatment.


Options:
A: Treatment emergent adverse events (Throughout the study period of approximately 2 year, 4 months)
B: Remission without steroids, immunosuppressives and without colectomy (week 16)
C: Safety and toleration (up to 12 weeks); Endoscopic score changes as calculated using section 3 of the Mayo Score (up to 12 weeks); Disease activity score changes as calculated using the Mayo Score (up to 12 weeks)
D: Clinical and Endoscopic Remission. (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Is the a Difference Between Rehabilitation Treatment, Pelvic Floor Muscle Training, Bladder Training and Anticholinergic Drug Treatment in UUI in the Long Term: A Study of Impairment, Quality of Life, and Cost Effectiveness
Brief Summary: * Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong sensation to void.
* UUI usually associated with reduced bladder capacity.
* The pathophysiology is unclear.
* Pelvic floor muscle dysfunction and detrusor instability have been suggested as possible mechanisms.
* Standard treatment includes anticholinergic medication and behavior modification.
* The study aims to compare the long term effectiveness of 4 different approaches to the treatment of women with Urge Urinary Incontinence (UUI):

  1. Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training)
  2. Pelvic Floor muscle training alone
  3. Bladder Training alone
  4. Drug treatment with Tolterodine.
* Study variables will include: impairment ratings, quality of life, and cost-effectiveness.
* This study addresses three issues:

  1. The long term efficacy and cost-effectiveness of the various treatment options.
  2. To identify the factors involved in determining the effectiveness of drug or behavioral therapy.
  3. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we hope to shed light on the mechanism of dysfunction. A better response in one group will help localize the problem to pelvic floor muscles or to detrusor instability.


Options:
A: Change from baseline in mean number of micturitions per 24 hours after 8 weeks (8 weeks)
B: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)
C: Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries. (Every 6 months for 4 years)
D: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. (Phase I, II, and III)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Is the a Difference Between Rehabilitation Treatment, Pelvic Floor Muscle Training, Bladder Training and Anticholinergic Drug Treatment in UUI in the Long Term: A Study of Impairment, Quality of Life, and Cost Effectiveness
Brief Summary: * Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong sensation to void.
* UUI usually associated with reduced bladder capacity.
* The pathophysiology is unclear.
* Pelvic floor muscle dysfunction and detrusor instability have been suggested as possible mechanisms.
* Standard treatment includes anticholinergic medication and behavior modification.
* The study aims to compare the long term effectiveness of 4 different approaches to the treatment of women with Urge Urinary Incontinence (UUI):

  1. Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training)
  2. Pelvic Floor muscle training alone
  3. Bladder Training alone
  4. Drug treatment with Tolterodine.
* Study variables will include: impairment ratings, quality of life, and cost-effectiveness.
* This study addresses three issues:

  1. The long term efficacy and cost-effectiveness of the various treatment options.
  2. To identify the factors involved in determining the effectiveness of drug or behavioral therapy.
  3. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we hope to shed light on the mechanism of dysfunction. A better response in one group will help localize the problem to pelvic floor muscles or to detrusor instability.


Options:
A: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. (Phase I, II, and III)
B: Change From Baseline to Week 12 in Bladder Wall Thickness (Baseline and Week 12); Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12 (Week 12)
C: Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition (Baseline and Week 12)
D: Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome (Weeks 1, 4, 8 and 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Is the a Difference Between Rehabilitation Treatment, Pelvic Floor Muscle Training, Bladder Training and Anticholinergic Drug Treatment in UUI in the Long Term: A Study of Impairment, Quality of Life, and Cost Effectiveness
Brief Summary: * Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong sensation to void.
* UUI usually associated with reduced bladder capacity.
* The pathophysiology is unclear.
* Pelvic floor muscle dysfunction and detrusor instability have been suggested as possible mechanisms.
* Standard treatment includes anticholinergic medication and behavior modification.
* The study aims to compare the long term effectiveness of 4 different approaches to the treatment of women with Urge Urinary Incontinence (UUI):

  1. Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training)
  2. Pelvic Floor muscle training alone
  3. Bladder Training alone
  4. Drug treatment with Tolterodine.
* Study variables will include: impairment ratings, quality of life, and cost-effectiveness.
* This study addresses three issues:

  1. The long term efficacy and cost-effectiveness of the various treatment options.
  2. To identify the factors involved in determining the effectiveness of drug or behavioral therapy.
  3. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we hope to shed light on the mechanism of dysfunction. A better response in one group will help localize the problem to pelvic floor muscles or to detrusor instability.


Options:
A: Predomination of type of birth, operative vaginal delivery versus natural spontaneous vaginal delivery (At time of delivery (~6 months after baseline)); Indication for operative vaginal delivery (if applicable) (At time of delivery (~6 months after baseline))
B: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. (Phase I, II, and III)
C: Change from baseline in mean number of micturitions per 24 hours after 8 weeks (8 weeks)
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Risk Factors in Veterans With Bipolar Disorder
Brief Summary: The purpose of this research study is to learn whether or not people with bipolar disorder can reduce their risk of heart disease and related conditions by having a Care Manager provide self management and care management.


Options:
A: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
B: Blood pressure (One year)
C: Reduction in symptoms of psychosis (6 months)
D: Systolic and Diastolic Blood Pressure (SBP, DBP) (24 months); Total Cholesterol (24 months); Physical Health-related Quality of Life Score (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD
Brief Summary: Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.


Options:
A: Onset of Effect of Vyvanse (Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.)
B: Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks (Baseline and 7 weeks)
C: Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. (Baseline, and the Endpoint (average of weeks 5, 6, 7).)
D: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Baseline (following ADHD medication washout of 7-28 days)); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 1); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 2); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 3); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 4); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 5); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 6)

Answer: B