TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).


Options:
A: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
B: A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. (2 years)
C: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
D: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Stage II Efficacy Study of Cognitive Behavioral Therapy for PTSD in Community Addiction Treatment
Brief Summary: The purpose of this phase of the study is to assess the efficacy of CBT for PTSD, as delivered by routine addiction counselors in community treatment programs, and to compare CBT for PTSD with both Individual Addiction Counseling (IAC) and Treatment as Usual (TAU) on the primary outcomes.


Options:
A: Decrease from baseline in PTSD symptom severity (Clinician Administered PTSD Scale (CAPS) score (30 day)) at 3-months and at 6-months (Baseline, 3-month, & 6-month follow-ups); Decrease from baseline in positive toxicology screens (urine drug screen and breathalyzer) at 3-months and at 6-months (Baseline, 3-month, & 6-month follow-ups); Decrease from baseline in drug and alcohol symptom severity (Addiction Severity Index (ASI)-Self Administered (30 day)) at 3-months and at 6-months (Baseline, 3-month, & 6-month follow-ups); Decrease from baseline in frequency of substance use (Timeline Follow-Back (TLFB) Interview (90 day)) at 3-months and at 6-months (Baseline, 3-month, & 6-month follow-ups)
B: Severity of Alcohol Use (ASI Alcohol Composite Scores) (Administered at baseline and 3 months, 6 months and 12 months post baseline.); ASI Drug Composite Score (1 year)
C: Drug abstinence
D: Alcohol and drug use (3, 6, and 12 months after baseline); Alcohol and drug-related problems (3, 6, and 12 months after baseline); Nights Hospitalized (3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled); Emergency department visits (3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Art Therapy as Treatment for Fear of Childbirth:a Randomized Controlled Study
Brief Summary: Earlier research has shown that pregnant women with a pronounced fear of childbirth have a significantly increased risk for birth complications and subsequent psychological trauma. In Sweden and also internationally, women in fear of childbirth are treated in many differing ways. Evidence for best care for these women is lacking. The Art Therapy method is a creative, psycho-therapeutic form of treatment which has been used for several decades within psychiatry. It has recently been seen that the Art Therapy method has positive effects during treatment for crisis reactions.

Recruitment has recently been initiated for a randomized controlled study of Art Therapy for the treatment of fear of childbirth.

The hypothesis for the study is as follows:

H1 = treatment with Art Therapy and therapeutic conversations will result in a decrease in fear of childbirth when compared to treatment by therapeutic conversations only.

The instrument which is to be used for measurement of childbirth fear is the Wijma Delivery Expectancy Questionnaire (W-DEQ). This is a well validated instrument which was developed in Sweden. A power calculation has shown a need for 62 x 2 participants; a total of 124 women.


Options:
A: Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ-A) (Change from the Wijma Delivery Expectancy/Experience Questionnaire Version A scores at pre-education and post-education (4 weeks later).); Childbirth Self-Efficacy Inventory (CBSEI) (Change from the Childbirth Self-efficacy Inventory scores at pre-education and post-education (4 weeks later).); The depression anxiety and stress scale (DASS-21) (Change from the Depression Anxiety and Stress Scale scores at pre- education, post-education (4 weeks later) and postpartum 6-8 weeks.); The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B) (Change from The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B) scores at postpartum 6-8 weeks.)
B: Level of childbirth related fear (FOBS) (36 weeks of gestation)
C: Scores for the Wijma Delivery Expectancy Questionnaire (W-DEQ) (Change in W-DEQ scores measured at entry to the study (approximately gestational weeks 20 to 31) and again at gestational week 36.)
D: number of spontaneous vaginal deliveries (after delivery within a month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PAIN CONTROL IN FIRST TRIMESTER MEDICAL ABORTION: A Randomized Trial
Brief Summary: This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain.


Options:
A: Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention. (Within 1 week)
B: • Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain). (2 weeks)
C: Maximum Pain Score Over Study Period (Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours))
D: 11-point Visual Analog Scale for Pain (1-2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi Center, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment (ARTDeCo)
Brief Summary: This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major depressive disorder having inadequate response to ongoing antidepressant treatment. Patients will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or matching placebo. The anticipated time on study treatment is 6 weeks.


Options:
A: Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores (6 weeks)
B: To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score (Baseline to week 3)
C: Montgomery-Asberg Depression Rating Scale (MADRS) (24 hours)
D: Episodes of Depression or Elation (15 months (duration of trial and 3 month follow-up))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi Center, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment (ARTDeCo)
Brief Summary: This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major depressive disorder having inadequate response to ongoing antidepressant treatment. Patients will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or matching placebo. The anticipated time on study treatment is 6 weeks.


Options:
A: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis (Baseline up to Day 28 of Double-blind Induction Phase); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis (Baseline up to Endpoint (Double-blind Induction Phase [Day 28]))
B: To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score (Baseline to week 3)
C: MADRS Score - Baseline (Baseline); MADRS Score - Day 1 Following Intervention (Day 1)
D: Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study
Brief Summary: The aim of this randomized crossover study, is to investigate the effect of school meals based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep quality, physical activity and risk markers of cardiovascular disease (CVD), type II diabetes and osteoporosis in 8-11 year old Danish school children.

The participating 3rd and 4th grades on 9 selected primary schools will be randomized to either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual school lunch for 3 mo and then crossover for additional 3 mo. All participants will be examined three times; at baseline, after 3 mo and after 6 mo.


Options:
A: Metabolic syndrome score (Change during 3 month of intervention compared with change during 3 month control period); Concentration Performance (Change during 3 month of intervention compared with change during 3 month control period)
B: Insulin area under the curve (oral glucose tolerance test) (10-15 weeks); Body composition (% body fat, visceral fat) (10-15 weeks); Aerobic fitness (10-15 weeks); Cognition (Executive function) (10-15 weeks)
C: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
D: body mass index trajectory (change) (baseline, 1, 2 and 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study
Brief Summary: The aim of this randomized crossover study, is to investigate the effect of school meals based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep quality, physical activity and risk markers of cardiovascular disease (CVD), type II diabetes and osteoporosis in 8-11 year old Danish school children.

The participating 3rd and 4th grades on 9 selected primary schools will be randomized to either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual school lunch for 3 mo and then crossover for additional 3 mo. All participants will be examined three times; at baseline, after 3 mo and after 6 mo.


Options:
A: Body mass index (One school year)
B: Metabolic syndrome score (Change during 3 month of intervention compared with change during 3 month control period); Concentration Performance (Change during 3 month of intervention compared with change during 3 month control period)
C: Change in body mass index in adults and body mass index percentile in children. (Baseline to 18 months.)
D: Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption (5 weeks); Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY) (5 weeks); Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans (5 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Open-Label Phase II Study to Assess the Efficacy & Safety of AZD4547 Monotherapy Versus Paclitaxel in Patients With Advanced Gastric Adenocarcinoma (Inc. Adenocarcinoma of the Lower Third of the Oesophagus or the Gastro-Oesophageal Junction)With FGFR2 Polysomy or Gene Amplification.
Brief Summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.


Options:
A: Progression Free Survival (PFS) in the Overall Study Population (Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months); Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients] (Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months)
B: Objective response rate (ORR) (about 10 month (until progression))
C: Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma (Up to 2 years post-treatment)
D: Median Progression Free Survival (Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Brief Summary: Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to be both well tolerated and efficacious in several indications, including a small, placebo-controlled trial in RRMS using an intravenous (IV) formulation.

This double-blind, placebo-controlled, parallel-group study will investigate the safety and efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS. The primary objective of the study is to investigate the efficacy as assessed by magnetic resonance imaging. Other objectives will include evaluation of tolerability/safety, dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well as other clinical endpoints.


Options:
A: Confirmed Annualized Relapse Rate (up to 12 months)
B: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)
C: Part A: Number of Participants With Adverse Events (AEs) (Baseline (Week 0) to Week 24); Part B: Rate of Development of New Active Lesions Over 24 Weeks (Baseline (Week 0) to Week 24)
D: Cumulative Number of New Gadolinium-enhancing (GdE) T1 Lesions at Week 12 (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Brief Summary: Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to be both well tolerated and efficacious in several indications, including a small, placebo-controlled trial in RRMS using an intravenous (IV) formulation.

This double-blind, placebo-controlled, parallel-group study will investigate the safety and efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS. The primary objective of the study is to investigate the efficacy as assessed by magnetic resonance imaging. Other objectives will include evaluation of tolerability/safety, dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well as other clinical endpoints.


Options:
A: The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (9 months)
B: Cumulative Number of New Gadolinium-enhancing (GdE) T1 Lesions at Week 12 (Week 12)
C: Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B (End of treatment (up to Week 6) for both Parts A and B)
D: Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis (day 28); Change in EDSS in patients who present a relapse from different type or unknown topography (day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia A
Brief Summary: The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes.


Options:
A: N/A
B: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)
C: Number of Participants With Adverse Events (From AMT-060 infusion through end of study (5 years post-dose))
D: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (up to 52 weeks ± 1 week); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Incidence Rate of FIX Inhibitor Development (up to 52 weeks ± 1 week); Annualized Bleeding Rate (up to 52 weeks ± 1 week (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates (up to 52 weeks ± 1 week (efficacy period as defined in description))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia A
Brief Summary: The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes.


Options:
A: Serious and non-serious AEs (4 weeks after infusion with BAX 855 and ADVATE)
B: To assess the safety of systemic administration of a novel self-complementary AAV vector in adults with severe hemophilia B at up to four different dosage levels. (15 years)
C: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)
D: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized) (Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.); Number of Subjects Developing Inhibitors Against Factor IX (FIX) (Up to 27.7 months (maximum))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia A
Brief Summary: The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes.


Options:
A: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)
B: Part A - Area Under the Drug Concentration-time Curve (AUC) (Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. AUC calculated from time of injection to infinity.); Part A - Half-life (t 1/2) (Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection.); Part B - Annualized Number of Total Bleeds (12 months after randomization)
C: Number of Participants With Any Positive Inhibitor Development (Approximately 5 years)
D: Evaluate the efficacy, safety and pharmacoeconomic of long-term secondary prophylaxis with Kogenate Bayer in comparison to on-demand treatment with Kogenate Bayer in terms of joint bleeding episodes per year (Every 6 months)

Answer: A