TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil - (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.


Options:
A: Rate of pathological complete remissions (20 weeks)
B: Relapse-free Survival Rates at 2.4 Years (randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years))
C: Pathologic Complete Response (pCR) of the Primary Tumor in the Breast (Time of surgery, on average 6 or 13 months)
D: Overall Survival (PP Population) (Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years); Overall Survival (ITT Population) (Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease
Brief Summary: This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.


Options:
A: Overall survival and Median Survival (Follow-up in intervals of 1, 3, 6, and 12 months after stent placement)
B: Event-free Survival (5 years)
C: Complete macroscopic resection (part 1) (After surgery (15 weeks after trial registration)); Loco-regional relapse-free survival (part 2) (From surgery until the first occurrence of loco-regional relapse)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease
Brief Summary: This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.


Options:
A: Event-free Survival (5 years)
B: Survival (12 years)
C: Progression-free survival
D: Progression free survival (PFS) (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders
Brief Summary: This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited. Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine (Tenex).


Options:
A: hyperactivity, impulsiveness, and distractibility
B: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score (baseline, 8 weeks after dosing)
C: Effect of Arbaclofen vs. placebo on social function (Week 0 + Week 16)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders
Brief Summary: This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited. Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine (Tenex).


Options:
A: 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))
B: Clinical Global Impression Improvement (CGI-AD) (Administered weekly, initial and week 8 reported)
C: hyperactivity, impulsiveness, and distractibility
D: 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

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in Children and Youth
Brief Summary: This study seeks to learn more about the symptoms of severe mood dysregulation in children and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (SMD) display chronic anger, sadness, or irritability, as well as hyperarousal (such as insomnia, distractibility, hyperactivity) and extreme responses to frustration (such as frequent, severe temper tantrums). Researchers will describe the moods and behaviors of children with these symptoms and use specialized testing and brain imaging to learn about the brain changes associated with this disorder....


Options:
A: Challenging Behaviour (12 months)
B: To examine between-group differences in clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables (20 years); To examine associations between irritability and clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables (20 years)
C: Change from baseline level of problem behavior at 4, 8, 12 and 16 weeks (0, 4, 8, 12, 16 weeks)
D: Aberrant Behavior Checklist scale (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
Brief Summary: This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.


Options:
A: Percentage of Randomized Patients Who Are Responders (Up to the first 6 cycles of treatment); Percentage of Patients in the Dinutuximab Arm Who Are Responders (Up to the first 6 cycles of treatment)
B: Event-Free Survival (EFS) (Three years)
C: Determine maximum tolerated dose and dose-limiting toxicity of the humanized monoclonal anti-GD2 antibody, hu14.18K322A, in research participants with neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma. (within 12 months of the start of therapy)
D: Event Free Survival (R1: MAT therapy) (Up to three years); Event Free Survival (immunotherapy) (Up to three years); Complete metastatic response (R3: Induction therapy) (Up to 95 days); Event free survival (R3: Induction therapy) (Up to three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
Brief Summary: This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.


Options:
A: Event-Free Survival (EFS) (Three years)
B: N/A
C: Event-free survival rate (Time from study registration until the time of the first occurrence of either relapse, progression, secondary malignancy, or death, or until the time of last contact with the patient if none of these events occurs, assessed up to 6 years); Rate of occurrence of toxic (non disease-related) deaths where a toxic death will be "counted" if it occurs prior to the initiation of the immunotherapy (Up to day 42)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trazodone for Sleep Disturbance - Early Alcohol Recovery
Brief Summary: This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)


Options:
A: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
B: Mean two-week sleep log estimate of post-treatment sleep continuity (An average of two-weeks post-treatment)
C: Percent days abstinent from alcohol (PDA) (12 and 24 weeks)
D: Number of Awakenings After Sleep Onset (NAASO) (4-Week maintenance treatment with milnacipran and placebo); Sleep Efficiency (SE) (4-Week maintenance treatment with milnacipran and placebo); Wake After Sleep Onset (WASO) (4-Week maintenance treatment with milnacipran and placebo)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.


Options:
A: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)
B: Adjusted Annualized Relapse Rate (ARR) (Up to 144 weeks)
C: The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. (1 year and 2 years)
D: Number of Days Until First On-study Relapse (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.


Options:
A: The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. (1 year and 2 years)
B: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)
C: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
D: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.


Options:
A: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)
B: The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (9 months)
C: Dose Responsiveness of BAF312 Based on the Number of Combined Unique Active MRI Lesions (CUAL) (3 months of treatment)
D: The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. (1 year and 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.


Options:
A: To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS (4 years)
B: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
C: The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. (1 year and 2 years)
D: Time to First Relapse (Baseline up to 96 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
Brief Summary: The purpose of this study is to compare two ways of using anti-HIV drugs to help health care providers and patients decide how to best use anti-HIV treatments over many years. Many health care providers now treat patients with daily drugs to keep the viral load as low as possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live longer without serious diseases. But it is not known if this is the best way to treat patients with higher CD4 counts. There is information suggesting that these patients may be able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this study will be carried out over several years, it will provide information on the long-term advantages and disadvantages of these two treatment strategies.


Options:
A: N/A
B: End-of-intervention Varenicline Adherence (4 Weeks)
C: Three month point-prevalence abstinence from cigarettes (3 months post-intervention)
D: smoking cessation (6-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacological Intervention Project (Fluoxetine)
Brief Summary: This is a large scale study involving fluoxetine (Prozac) versus a placebo in the treatment of adolescents with alcohol use disorder (AUD) and major depression (MDD). All individuals will receive treatment for 12 weeks with a followup phase lasting 9 months.


Options:
A: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint (Baseline, Week 10)
B: Alcohol Use Behaviors (Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.); Depressive Symptoms (Average score as measured by participant's report on the Beck Depression Inventory (BDI).)
C: Percentage of Participants Experiencing a Treatment Emergent Adverse Event (Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study)
D: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint (Baseline, Week 10)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacological Intervention Project (Fluoxetine)
Brief Summary: This is a large scale study involving fluoxetine (Prozac) versus a placebo in the treatment of adolescents with alcohol use disorder (AUD) and major depression (MDD). All individuals will receive treatment for 12 weeks with a followup phase lasting 9 months.


Options:
A: Alcohol Use Behaviors (Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.); Depressive Symptoms (Average score as measured by participant's report on the Beck Depression Inventory (BDI).)
B: Mood Severity Index (Measured at Months 6 and 12)
C: N/A
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
Brief Summary: RATIONALE: Gabapentin may be effective in relieving pain and other symptoms of peripheral neuropathy. It is not yet known if gabapentin is effective in treating peripheral neuropathy in cancer patients undergoing chemotherapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of gabapentin in treating pain and other symptoms of peripheral neuropathy in cancer patients undergoing chemotherapy.


Options:
A: Change in pain and symptoms (Up to 14 weeks)
B: Alteration of pain intensity after treatment (5 weeks)
C: The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the mean daily pain score from the baseline week to end of efficacy treatment period (Treatment Week 4) in patients with DPN. (4 weeks)
D: Change From Baseline to End of Study in LOCF VAS (8 weeks (Baseline and Week 8))

Answer: A