TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis.
Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
B: 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)
C: Change in PASI score from baseline in the two groups (12 weeks)
D: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) (Week 16); Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) (Week 44)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis.
Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Number of Participants With Clinical Remission at Week 44 (Week 44)
B: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
C: Number of Participants With Clinical Response at Week 6 (Baseline to Week 6)
D: Number of Participants With Clinical Response at Week 6 (Baseline and Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis
Brief Summary: The aim of IMPROVE is to define the optimal maintenance therapy for ANCA-associated vasculitides (AASV) by comparing the AZA (standard regimen) with MMF in terms of efficacy, i.e. in preventing relapses.

HYPOTHESIS :

MMF might be more effective than azathioprine as maintenance drug in AASV patients, reducing by 50% relapse rate, with a same frequency of adverse effects


Options:
A: Relapse-free Survival (Any patients who have not relapsed at up to a maximum of 4 years will be censored.)
B: Remission rates at 6 months (6 months)
C: the disease-free period, defined as the time between the beginning; of the maintenance therapy (AZA or MMF) and the first relapse (minor or major); or the end of the protocol (at 48 months)
D: Number of side effects (morbidity) (at 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener's Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective Trial
Brief Summary: The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides.


Options:
A: the remission rate after 9 months of therapy with intravenous immunoglobulins,; in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome); during 6 months, after relapse
B: Number of events (failures, relapses and/or deaths) occurring in each group, defining the disease-free survival rate, measured at study end (mean follow-up of 5 years)
C: Disease free period, time from remission to relapse or study end.
D: Safety/Efficacy; Frequency of severe adverse events in each arm. Hypothesis based upon NIH data was a rate of 6% severe adverse event with methotrexate compared to 30% with azathioprine (24% in one study on RA and 46% in one study on Sjögren syndrome).; Evaluation was planned after the last included patient has completed the assigned trial regimen (after 12 months of maintenance regimen or because of drug withdrawal).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants
Brief Summary: The aim of this trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides, by reducing mortality and improving global outcome.


Options:
A: Number of side effects (morbidity) (at 3 years)
B: Time to First Relapse (Approximately up to 4 years)
C: disease free survival (four years after diagnosis)
D: Renal recovery (Three months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open International Multicentre Long-Term Follow Up Study to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder
Brief Summary: Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a developmental disorder beginning in childhood and characterized by developmentally inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult patients with ADHD is limited, but it is estimated that approximately 50% of children with ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS methylphenidate. The active ingredient is methylphenidate and the tablet is designed to release the active ingredient gradually to ensure an effect, which lasts up to 12 hours. Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate. This 5-week period was followed by a 7-week period, where patients received OROS methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete 42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate over a long period of time.

Amendment: At the end of the open-label period of the present study 42603ATT3004, patients are enrolled into a double-blind placebo-controlled period, which lasts an additional 4 weeks. The purpose of this double-blind placebo-controlled period is to evaluate the maintenance of effect under continued treatment with OROS methlyphenidate in comparison to treatment cessation in those patients, who are randomized into the placebo-group.


Options:
A: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)
B: Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase (2, 4, 8, 10, 12 and 14 hours post-dose on Day 7)
C: N/A
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open International Multicentre Long-Term Follow Up Study to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder
Brief Summary: Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a developmental disorder beginning in childhood and characterized by developmentally inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult patients with ADHD is limited, but it is estimated that approximately 50% of children with ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS methylphenidate. The active ingredient is methylphenidate and the tablet is designed to release the active ingredient gradually to ensure an effect, which lasts up to 12 hours. Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate. This 5-week period was followed by a 7-week period, where patients received OROS methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete 42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate over a long period of time.

Amendment: At the end of the open-label period of the present study 42603ATT3004, patients are enrolled into a double-blind placebo-controlled period, which lasts an additional 4 weeks. The purpose of this double-blind placebo-controlled period is to evaluate the maintenance of effect under continued treatment with OROS methlyphenidate in comparison to treatment cessation in those patients, who are randomized into the placebo-group.


Options:
A: Number of days of use of cannabis (12 weeks)
B: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)
C: 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)
D: Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose (Pre-dose to 10, 11, and 12 hours post-dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open International Multicentre Long-Term Follow Up Study to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder
Brief Summary: Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a developmental disorder beginning in childhood and characterized by developmentally inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult patients with ADHD is limited, but it is estimated that approximately 50% of children with ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS methylphenidate. The active ingredient is methylphenidate and the tablet is designed to release the active ingredient gradually to ensure an effect, which lasts up to 12 hours. Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate. This 5-week period was followed by a 7-week period, where patients received OROS methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete 42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate over a long period of time.

Amendment: At the end of the open-label period of the present study 42603ATT3004, patients are enrolled into a double-blind placebo-controlled period, which lasts an additional 4 weeks. The purpose of this double-blind placebo-controlled period is to evaluate the maintenance of effect under continued treatment with OROS methlyphenidate in comparison to treatment cessation in those patients, who are randomized into the placebo-group.


Options:
A: Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.
B: Wender Reimherr Adult Attention Deficit Disorder Scale (Double-blind endpoints during MTS and placebo arms)
C: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Body-weight Supported Therapy Using Gait Trainer Versus Traditional Gait-oriented Physiotherapy in Acute Phase of Stroke. The Effectiveness of Gait Training and Brain Networks Using NBS (Navigating Brain Stimulation)
Brief Summary: This is a trial aiming to evaluate the difference of effectiveness between two therapy methods in patients with acute stroke. The other aim is to use Navigated Brain Stimulation (NBS)to analyze changes in brain networks during the recovery and as the consequence of rehabilitation. The groups are:

* body-weight supported gate trainer rehabilitation
* gait-oriented traditional physiotherapy Patients in physiotherapy group will have 75 min physiotherapy daily every workday. This includes 20 minutes walking exercises in the traditional group while 20 minutes of gait trainer therapy in the gait trainer group. The evaluation of effectiveness of therapy in each group is made after three weeks' therapy and at six months. The goal is to have 40 patients until the end of June 2006.


Options:
A: Improvement ín motor function among patients in each group
B: walking speed (meters/second); walking distance (distance walked in 6-minutes)
C: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)
D: Change from Baseline in the gait velocity (Baseline, immediately after and six weeks after training cessation.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Body-weight Supported Therapy Using Gait Trainer Versus Traditional Gait-oriented Physiotherapy in Acute Phase of Stroke. The Effectiveness of Gait Training and Brain Networks Using NBS (Navigating Brain Stimulation)
Brief Summary: This is a trial aiming to evaluate the difference of effectiveness between two therapy methods in patients with acute stroke. The other aim is to use Navigated Brain Stimulation (NBS)to analyze changes in brain networks during the recovery and as the consequence of rehabilitation. The groups are:

* body-weight supported gate trainer rehabilitation
* gait-oriented traditional physiotherapy Patients in physiotherapy group will have 75 min physiotherapy daily every workday. This includes 20 minutes walking exercises in the traditional group while 20 minutes of gait trainer therapy in the gait trainer group. The evaluation of effectiveness of therapy in each group is made after three weeks' therapy and at six months. The goal is to have 40 patients until the end of June 2006.


Options:
A: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)
B: Self selected over ground gait speed - 5 metre walk test (8 week follow up)
C: walking speed (meters/second); walking distance (distance walked in 6-minutes)
D: Improvement ín motor function among patients in each group

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Association Amongst Acupuncture Analgesia, Expectancy, and Psychiatric Comorbidity in Patients With Low Back Pain
Brief Summary: It is our hypothesis that patient's expectations concerning treatment outcome will be influenced by their psychiatric symptoms, and that this expectancy will have a strong influence on the efficacy of acupuncture treatment to suppress experimentally induced pain. We will conduct a study, monitoring expectations but not manipulating them, in a cohort of patients with chronic low back pain.


Options:
A: Days with pain (Change from baseline to follow-up after 16 weeks); Physical functioning (Change from baseline to follow-up after 16 weeks); Role physical (Change from baseline to follow-up after 16 weeks); Bodily pain (Change from baseline to follow-up after 16 weeks); General health (Change from baseline to follow-up after 16 weeks); Vitality (Change from baseline to follow-up after 16 weeks); Social functioning (Change from baseline to follow-up after 16 weeks); Role emotional (Change from baseline to follow-up after 16 weeks); Mental health (Change from baseline to follow-up after 16 weeks); Disability (Change from baseline to follow-up after 16 weeks); Stress (Change from baseline to follow-up after 16 weeks); Well-being (Change from baseline to follow-up after 16 weeks); Use of prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of non-prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of conventional care (Change from baseline to follow-up after 16 weeks); Use of complementary care (Change from baseline to follow-up after 16 weeks)
B: 11-point Short Pain Scale (SPS-11) (20 minute)
C: N/A
D: Pain relief (start and end)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding.
Brief Summary: The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.


Options:
A: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms (Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7)
B: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms (during a time period of 90 days under treatment)
C: Amenorrhoea (6 months after the intervention.)
D: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) (Baseline MBL over 6 menstrual cycles)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications
Brief Summary: A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.


Options:
A: Percentage of patients withdrawn because of gastrointestinal effects (Week 9)
B: Change in HbA1c From Baseline to Week 30 (Day -3, Week 30); Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose) (Week 22)
C: Mean Change From Baseline in Body Weight at Week 20 (Week 0, week 20)
D: Change in HbA1c From Baseline to Week 26 (Baseline, Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Tapering or Standard Steroids for Nephrotic Syndrome
Brief Summary: Parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime


Options:
A: Relapse of nephrotic syndrome during 12 months after randomization (12 month period following randomization)
B: Time to first relapse (5 months); Assessment of steroid induced morbidity (5 months)
C: Remission (4 to 16 weeks)
D: complete remission (within 4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Risperidone Alone Vs. Risperidone Plus Valproate in the Treatment of Patients With Schizophrenia and Hostility
Brief Summary: This is an eight-week open-label randomized parallel group clinical trial focusing on the comparison of risperidone alone with risperidone plus valproate among hospitalized adult patients diagnosed with schizophrenia who also exhibit problems with hostility. Patients may have already been receiving risperidone or valproate (but not both) at study entry. Patients not receiving valproate at study entry were randomized to receive either risperidone alone or risperidone with valproate. For patients already receiving valproate at study entry, their antipsychotic medication(s) was switched to risperidone, and they were followed for a four-week lead-in period prior to baseline assessment and randomization to receive risperidone alone or continue with risperidone and valproate. We hypothesized that risperidone alone has an antiaggressive/antihostility effect, and that this effect is augmented by the co-administration of valproate.


Options:
A: Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale (Baseline and 6 weeks)
B: Positive and Negative Syndrome Scale - Excited Component (Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.)
C: Buss-Durkee Hostility Inventory; Barratt Impulsiveness Scale
D: N/A

Answer: C