TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions for Cardiovascular Disease: "Real-World" Effectiveness of Combined Pharmacotherapy and Behavioural Counseling for Smoking Cessation
Brief Summary: Research Aims

The aims of this research study are:

1. To determine which of the following three smoking cessation medications is most effective in achieving cessation:

   * Nicotine Patch
   * Nicotine Patch + gum or inhaler
   * Varenicline (Champix;
2. To investigate how often participants experience neuropsychiatric symptoms over the course of their cessation attempt and to assess whether:

   * They occur more often when taking one medication versus another
   * They occur more often in those with or without psychiatric illnesses.

Hypotheses to be Tested

The hypotheses to be tested include the following:

1. The CO-confirmed continuous abstinence rate from 5 weeks to 52 weeks following a target quit date will be significantly higher in smokers receiving long-term transdermal NRT in combination with other NRT products or those receiving varenicline compared to those receiving transdermal NRT alone.
2. Some participants will experience neuropsychiatric symptoms during their cessation attempt, and those in the varenicline group will experience a greater incidence of neuropsychiatric symptoms than those in the groups receiving transdermal NRT alone or in combination with other NRT products. Patients with psychiatric illnesses will report higher levels of withdrawal symptoms than those without psychiatric illnesses.


Options:
A: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
B: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)
C: The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date)
D: 7-day smoking abstinence (7 days); 6-month smoking abstinence (6 months); cost-effectiveness (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions for Cardiovascular Disease: "Real-World" Effectiveness of Combined Pharmacotherapy and Behavioural Counseling for Smoking Cessation
Brief Summary: Research Aims

The aims of this research study are:

1. To determine which of the following three smoking cessation medications is most effective in achieving cessation:

   * Nicotine Patch
   * Nicotine Patch + gum or inhaler
   * Varenicline (Champix;
2. To investigate how often participants experience neuropsychiatric symptoms over the course of their cessation attempt and to assess whether:

   * They occur more often when taking one medication versus another
   * They occur more often in those with or without psychiatric illnesses.

Hypotheses to be Tested

The hypotheses to be tested include the following:

1. The CO-confirmed continuous abstinence rate from 5 weeks to 52 weeks following a target quit date will be significantly higher in smokers receiving long-term transdermal NRT in combination with other NRT products or those receiving varenicline compared to those receiving transdermal NRT alone.
2. Some participants will experience neuropsychiatric symptoms during their cessation attempt, and those in the varenicline group will experience a greater incidence of neuropsychiatric symptoms than those in the groups receiving transdermal NRT alone or in combination with other NRT products. Patients with psychiatric illnesses will report higher levels of withdrawal symptoms than those without psychiatric illnesses.


Options:
A: Validated smoking cessation (6 months)
B: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
C: The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date)
D: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of Therapeutic Effect and Safety of Combined Hydroxyurea With Recombinant Human Erythropoietin.
Brief Summary: The study hypothesis that treatment with Erythropoietin (EPO) combined with Human Erythropoietin (HUO) therapy will result in hematologic improvement in thalassemia intermedia patients.

Second is to determine whether any of the following correlate with improved hematologic response:

A decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline levels,baseline Erythropoietin levels,baseline hemoglobin levels and baseline reticulocyte counts (or % circulating nucleated erythroblasts/100 WBCs).

Goal:

The aim is to assess the possibility of steady increase of hemoglobin levels in thalassemia intermedia patients by at least 1g/dl above baseline levels during therapy using Hydroxyurea and Erythropoietin, growth evaluation,quality of life (QoL) and decline transfusion requirements during study period. Also to report and compare adverse events with other published data regarding.


Options:
A: The Effective Rate of Patients (24 months)
B: Change from baseline in % fetal hemoglobin (Day 1 through Week 48)
C: Number of Evaluable Patients With an Increase From Baseline in Hemoglobin (Hb) of ≥1.5 g/dL (up to 12 weeks); Change in Total Hemoglobin (Hb) From Baseline to Peak (the Follow-up Time Point With the Highest Value) (up to 12 weeks)
D: Change in baseline transfusion frequency with increase of pre-transfusion hemoglobin (baseline and 6 month hemoglobin level and transfusion frequency)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of Evolocumab (AMG145) on LDL-C in Subjects With Severe Familial Hypercholesterolemia
Brief Summary: A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.


Options:
A: Change From Baseline in Percent Atheroma Volume at Week 78 (Baseline and week 78)
B: Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
C: Number of Participants With Adverse Events (From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months.)
D: Percent Change From Baseline in Calculated LDL-C in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis (From Baseline to Week 24); Percent Change From Baseline in Calculated LDL-C in Participants Receiving Concomitant Statin Therapy - Intent-to-Treat (ITT Analysis) (From Baseline to Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo Controlled Trial of Intranasal Oxytocin Treatment for Social Deficits in Children With Autism.
Brief Summary: Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication, and the presence of repetitive or stereotyped behaviors. It is one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88 children in the United States. At present, pharmacotherapies target only associated features of autism, with no effective drug treatments for the social impairments. Several lines of evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for the core social deficits in autism. Here we will test the effects of twice daily intranasal OT (24 IU) over a 4-week period for enhancing social deficits in male and female children aged 6-12 years with autism. This research has high potential to lead to the development of more effective treatments and earlier interventions for children with autism.


Options:
A: Home Situations Questionnaire (Week 24); Vineland Daily Living Skills Scale (Week 24)
B: Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. (Baseline; Week 4)
C: Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) (4, 8, and 12 weeks); The Clinical Global Rating Scale (CGRS) Improvement Subscale Score (12 weeks); Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC) (12 weeks); Irritability Subscale of the Aberrant Behavior Checklist (ABC) (baseline and 12 weeks)
D: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo Controlled Trial of Intranasal Oxytocin Treatment for Social Deficits in Children With Autism.
Brief Summary: Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication, and the presence of repetitive or stereotyped behaviors. It is one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88 children in the United States. At present, pharmacotherapies target only associated features of autism, with no effective drug treatments for the social impairments. Several lines of evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for the core social deficits in autism. Here we will test the effects of twice daily intranasal OT (24 IU) over a 4-week period for enhancing social deficits in male and female children aged 6-12 years with autism. This research has high potential to lead to the development of more effective treatments and earlier interventions for children with autism.


Options:
A: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)
B: Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. (Baseline; Week 4)
C: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
D: Rate of Recruitment (19 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo Controlled Trial of Intranasal Oxytocin Treatment for Social Deficits in Children With Autism.
Brief Summary: Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication, and the presence of repetitive or stereotyped behaviors. It is one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88 children in the United States. At present, pharmacotherapies target only associated features of autism, with no effective drug treatments for the social impairments. Several lines of evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for the core social deficits in autism. Here we will test the effects of twice daily intranasal OT (24 IU) over a 4-week period for enhancing social deficits in male and female children aged 6-12 years with autism. This research has high potential to lead to the development of more effective treatments and earlier interventions for children with autism.


Options:
A: Autism Diagnostic Observation Schedule-Generic (ADOS-G)- Change from Baseline to Final Visit; Clinical Global Impression Improvement (CGI)- Change from Baseline to Final Visit; Aberrant Behavior Checklist (ABC) (hyperactivity/irritability sections)- Change from Baseline to Final Visit; Vineland Adaptive Behavior Scale- Change from Baseline to Final Visit; MacArthur Communicative Development Inventory (MCDI)- Change from Baseline to Final Visit; Conners' Parent Rating Scale-Revised: Long form (CPRS-R:L)- Change from Baseline to Final Visit
B: Rate of Recruitment (19 months)
C: Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. (Baseline; Week 4)
D: To evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children 2-6 years measuring the change from baseline in ADOS (Autism Diagnostic Observation Schedule) Composite Total scores compared to placebo at 6 months. (Baseline 1, Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)
Brief Summary: The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.


Options:
A: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 Weeks)
B: Hypoglycaemic Events (78 weeks plus 1 week of follow-up); Change From Baseline to Week 78 in Lipid Parameters (Weeks 1 and 78); Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements (78 weeks plus 1 week of follow-up)
C: Steady State Beta Cell Compensation (24 months)
D: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial to Determine the Effectiveness of Trauma Focused Cognitive Behavioral (TF-CBT) Among Children in Lusaka, Zambia
Brief Summary: The purpose of this study is to study the effectiveness of Trauma Focused Cognitive Behavioral Therapy in subset of children who are affected by trauma with significant mental health symptomatology in order to 1) examine the effectiveness of TF-CBT in reducing the severity of mental health symptoms experienced by traumatized children and adolescents in Lusaka and 2) determine the effectiveness of TF-CBT in reducing HIV risk taking behaviors and increasing coping strategies and health promotion activities in traumatized children and adolescents in Lusaka. The study will be integrated into current programing of the Serenity Harm Reduction Programme, a community and faith based organization focusing on mental health and substance use prevention and treatment, and its partners in 5 compounds.


Options:
A: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
B: Change in Difficulties in Emotion Regulation (baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)); Change in General Health (baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment))
C: Patient Health Questionnaire (PHQ-9) (8 weeks); WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (8 weeks)
D: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial to Determine the Effectiveness of Trauma Focused Cognitive Behavioral (TF-CBT) Among Children in Lusaka, Zambia
Brief Summary: The purpose of this study is to study the effectiveness of Trauma Focused Cognitive Behavioral Therapy in subset of children who are affected by trauma with significant mental health symptomatology in order to 1) examine the effectiveness of TF-CBT in reducing the severity of mental health symptoms experienced by traumatized children and adolescents in Lusaka and 2) determine the effectiveness of TF-CBT in reducing HIV risk taking behaviors and increasing coping strategies and health promotion activities in traumatized children and adolescents in Lusaka. The study will be integrated into current programing of the Serenity Harm Reduction Programme, a community and faith based organization focusing on mental health and substance use prevention and treatment, and its partners in 5 compounds.


Options:
A: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
B: depression symptom severity (3-6 months)
C: Change in post-traumatic stress symptoms measured by UCLA-PTSD-RI (Post-intervention and 3 month)
D: Change of depression symptom from baseline at 3 and 6 months (0-3-6 months); Change of anxiety symptom from baseline at 3 and 6 months (0-3-6 months); Change of chronic pain symptom from baseline at 3 and 6 months (0-3-6 months); Change of anger from baseline at 3 and 6 months (0-3-6 months); Change of PTSD symptom from baseline at 3 and 6 months (0-3-6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial to Determine the Effectiveness of Trauma Focused Cognitive Behavioral (TF-CBT) Among Children in Lusaka, Zambia
Brief Summary: The purpose of this study is to study the effectiveness of Trauma Focused Cognitive Behavioral Therapy in subset of children who are affected by trauma with significant mental health symptomatology in order to 1) examine the effectiveness of TF-CBT in reducing the severity of mental health symptoms experienced by traumatized children and adolescents in Lusaka and 2) determine the effectiveness of TF-CBT in reducing HIV risk taking behaviors and increasing coping strategies and health promotion activities in traumatized children and adolescents in Lusaka. The study will be integrated into current programing of the Serenity Harm Reduction Programme, a community and faith based organization focusing on mental health and substance use prevention and treatment, and its partners in 5 compounds.


Options:
A: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)
B: Change in adolescent mental health symptoms (baseline, 4 month followup, and 12 month followup); Change in parent mental health symptoms (baseline, 4 month followup, 12 month followup); Change in parent-child conflict (baseline, 4 month followup, 12 month followup); Change in parent-child relationship quality (baseline, 4 month followup, 12 month followup)
C: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
D: PTSD symptoms (Measured before and after treatment and Months 6 and 12 of follow-up); Anxiety (Measured before and after treatment and Months 6 and 12 of follow-up); Depression (Measured before and after treatment and Months 6 and 12 of follow-up); Behavior (Measured before and after treatment and Months 6 and 12 of follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial to Determine the Effectiveness of Trauma Focused Cognitive Behavioral (TF-CBT) Among Children in Lusaka, Zambia
Brief Summary: The purpose of this study is to study the effectiveness of Trauma Focused Cognitive Behavioral Therapy in subset of children who are affected by trauma with significant mental health symptomatology in order to 1) examine the effectiveness of TF-CBT in reducing the severity of mental health symptoms experienced by traumatized children and adolescents in Lusaka and 2) determine the effectiveness of TF-CBT in reducing HIV risk taking behaviors and increasing coping strategies and health promotion activities in traumatized children and adolescents in Lusaka. The study will be integrated into current programing of the Serenity Harm Reduction Programme, a community and faith based organization focusing on mental health and substance use prevention and treatment, and its partners in 5 compounds.


Options:
A: Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors (24-months post-intervention)
B: Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) (3 months, 6 months and 1 year after completion of treatment)
C: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)
D: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Brief Summary: The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in children and adolescents with irritability associated with autistic disorder.


Options:
A: Rate of Recruitment (19 months)
B: N/A
C: The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores (Baseline, Week 8)
D: Home Situations Questionnaire (Week 24); Vineland Daily Living Skills Scale (Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Brief Summary: The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in children and adolescents with irritability associated with autistic disorder.


Options:
A: Yale-Brown Obsessive Compulsive Scale (YBOCS): to measure repetitive behaviors (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Aberrant Behavior Checklist (ABC): to measure aggression and irritability (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks); Clinical Global Impression - Improvement (CGI-I): to measure global functioning (baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks)
B: Children's Psychiatric Rating Scale (Weekly)
C: N/A
D: The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores (Baseline, Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Brief Summary: The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in children and adolescents with irritability associated with autistic disorder.


Options:
A: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (Baseline; Week 4)
B: Aberrant Behavior Checklist Hyperactivity Subscale (Week 8)
C: Children's Psychiatric Rating Scale (Weekly)
D: The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores (Baseline, Week 8)

Answer: D