TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose-response to Exercise in Women Aged 45-75 Years (DREW)
Brief Summary: To investigate the effects of different amounts of exercise on both cardiorespiratory fitness and risk factors for cardiovascular disease in sedentary, overweight, mildly hypertensive, but healthy, postmenopausal women aged 45 to 75 years.


Options:
A: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
B: Measured at Week 16 and Months 6 and 12 post-treatment: Post-treatment recovery from MDD; Post-treatment depression scores on the Hamilton Depression Rating Scale
C: HAMD-17
D: VO2max and resting systolic blood pressure (at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma
Brief Summary: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.


Options:
A: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
B: myeloperoxidase in induced sputum (3 weeks)
C: reduction of number of exacerbations; reduction of number of hospitalisations
D: Overall Survival (Up to 9 years); Progression-free Survival (From the date of enrollment to first progression or death or last contact, if alive and progression free.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma
Brief Summary: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.


Options:
A: Overall Survival (Up to 9 years); Progression-free Survival (From the date of enrollment to first progression or death or last contact, if alive and progression free.)
B: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
C: Number of exacerbations after 48 weeks of intermittent pulse treatment (After 48 weeks of treatment)
D: Mean change in the Leicester Cough Questionnaire (LCQ) scores. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma
Brief Summary: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer. Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.


Options:
A: Overall Survival (Up to 9 years); Progression-free Survival (From the date of enrollment to first progression or death or last contact, if alive and progression free.)
B: Estimation of crude mortality by any reason of each study group; Estimation of attributable mortality by VAP of each study group; 7-day mortality rate of each group; 28-mortality rate of each group; Rate of progression to multiple organ failure and septic shock (and number of failing organs) of each study group; Time to progression to multiple organ failure and septic shock of each study group; Days of resolution of VAP; Days in ICU after diagnosis of VAP
C: Composite consisting of: death regardless of cause; non-fatal AMI or; unstable angina pectoris whichever occurred first
D: degree of food stasis (when endoscopy is performed.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)
Brief Summary: A long-term study of current treatments for bipolar disorder, including medications and psychosocial therapies.


Options:
A: N/A
B: Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline (6- and12-month follow-ups)
C: Reduction in symptoms of psychosis (6 months)
D: Change in Program Participation (6, 12, 18, and 24 months); Change in Program Fidelity (6, 12, and 24 months); Change in Participant Weight (Baseline, quarterly through 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)
Brief Summary: The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV) followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of children. This study will also look at the protection provided by childhood vaccination against measles, pertussis, and hepatitis B virus.

Pneumococcal infections are the most common AIDS-related infection in HIV-infected children. PCV may help reduce the chances of HIV-infected children getting pneumococcal infections. This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected children receiving HAART. It will look at whether HIV-infected children are protected by childhood vaccines received previously and if more doses are safe and improve protection.


Options:
A: Qualitative Seroresponsiveness to Hepatitis B Surface Antigen (Week (Wk) 28 (One month after the second immunization)); Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE)) (Week 12, Week 24, Week 28, Week 76); Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) (Week 12, Week 24, Week 28, Week 76)
B: Grade 3 or higher adverse events attributable to the vaccine. Mild and moderate adverse event rates will also be tabulated (At Day 0 and throughout study); Cell-mediated immunologic response as measured by HIV-specific cytotoxic T-lymphocyte activity against viral antigens (At Day 0 and throughout study); Humoral immunologic response as measured by detection of binding antibody to vaccine antigens and by neutralizing antibody assay (At Day 0 and throughout study)
C: N/A
D: Sero-response to Hepatitis B Surface Antigen (Week 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)
Brief Summary: The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate.


Options:
A: N/A
B: The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality within 12 months.
C: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) (Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]); Change From Baseline in CGI-I at End of Study (up to 5 Years) (Baseline, up to 5 years (End of Study [LOCF])); Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) (Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]); Change From Baseline in CGI-S at End of Study (up to 5 Years) (Baseline, up to 5 years (End of Study [LOCF]))
D: Reduction of PANSS total score (Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)
Brief Summary: The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate.


Options:
A: Composite MATRICS Consensus Cognitive Battery Score (4 weeks)
B: N/A
C: To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score (28 days)
D: The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: After Mapping Of The Axilla: Radiotherapy Or Surgery
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer.


Options:
A: N/A
B: Morbidity - Number of Participants With Residual Shoulder Abduction Deficit (Before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Volume Difference (before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Numbness (before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Tingling (before and after surgery (within 30 days of randomization)); Overall Survival (8 years); Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event. (8 years)
C: Axillary recurrence rate (from randomization)
D: Overall Survival (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens
Brief Summary: A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications. This trial will test whether more than one course of antenatal steroids is more beneficial or risky to the infant than a single course.


Options:
A: Neonatal Composite Outcome (72 hours of life)
B: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
C: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
D: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens
Brief Summary: A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications. This trial will test whether more than one course of antenatal steroids is more beneficial or risky to the infant than a single course.


Options:
A: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
B: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
C: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
D: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Placebo-Controlled Trial of Antenatal Corticosteroid Regimens
Brief Summary: A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications. This trial will test whether more than one course of antenatal steroids is more beneficial or risky to the infant than a single course.


Options:
A: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years
B: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
C: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
D: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)
Brief Summary: The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease who are having trouble with their thinking or behavior. In particular, this study is trying to find out the best treatment for people who have hallucinations (seeing or hearing things that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to increase the chance that participants in the study receive a medication that helps them. The study uses three medications known as atypical antipsychotics (olanzapine, quetiapine, risperidone), which are the newest medications that are currently available for treating these problems. Participants may also receive an antidepressant (citalopram). The trial lasts for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this study is appropriate. In addition, the caregiver, family member, or friend who comes with the participant will be offered an educational program about Alzheimer's disease.


Options:
A: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)
B: Antipsychotic Efficacy (Day 43)
C: N/A
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)
Brief Summary: The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease who are having trouble with their thinking or behavior. In particular, this study is trying to find out the best treatment for people who have hallucinations (seeing or hearing things that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to increase the chance that participants in the study receive a medication that helps them. The study uses three medications known as atypical antipsychotics (olanzapine, quetiapine, risperidone), which are the newest medications that are currently available for treating these problems. Participants may also receive an antidepressant (citalopram). The trial lasts for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this study is appropriate. In addition, the caregiver, family member, or friend who comes with the participant will be offered an educational program about Alzheimer's disease.


Options:
A: N/A
B: The outcome measure will be rate of patients falls per 1000 patient days (1/2009-6/2009)
C: Proportion of residents receiving at least one antipsychotic medication after 12 months (12 months)
D: Length of Stay (At time of discharge from hospital (an expected average of 8 days post admission))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)
Brief Summary: The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease who are having trouble with their thinking or behavior. In particular, this study is trying to find out the best treatment for people who have hallucinations (seeing or hearing things that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to increase the chance that participants in the study receive a medication that helps them. The study uses three medications known as atypical antipsychotics (olanzapine, quetiapine, risperidone), which are the newest medications that are currently available for treating these problems. Participants may also receive an antidepressant (citalopram). The trial lasts for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this study is appropriate. In addition, the caregiver, family member, or friend who comes with the participant will be offered an educational program about Alzheimer's disease.


Options:
A: Relapse by Study Week 32 (0-16 weeks in Phase B (16-32 weeks in study))
B: Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician (24 months)
C: N/A
D: Apathy (at baseline); Apathy (after 8 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)
Brief Summary: The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease who are having trouble with their thinking or behavior. In particular, this study is trying to find out the best treatment for people who have hallucinations (seeing or hearing things that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to increase the chance that participants in the study receive a medication that helps them. The study uses three medications known as atypical antipsychotics (olanzapine, quetiapine, risperidone), which are the newest medications that are currently available for treating these problems. Participants may also receive an antidepressant (citalopram). The trial lasts for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this study is appropriate. In addition, the caregiver, family member, or friend who comes with the participant will be offered an educational program about Alzheimer's disease.


Options:
A: N/A
B: NeuroBehavior Rating Scale-- Agitation (9 weeks); Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC) (Baseline to 9 weeks)
C: Cohen-Mansfield Agitation Inventory - long form (CMAI) (CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.)
D: Cohen-Mansfield (2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)
Brief Summary: The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease who are having trouble with their thinking or behavior. In particular, this study is trying to find out the best treatment for people who have hallucinations (seeing or hearing things that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to increase the chance that participants in the study receive a medication that helps them. The study uses three medications known as atypical antipsychotics (olanzapine, quetiapine, risperidone), which are the newest medications that are currently available for treating these problems. Participants may also receive an antidepressant (citalopram). The trial lasts for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this study is appropriate. In addition, the caregiver, family member, or friend who comes with the participant will be offered an educational program about Alzheimer's disease.


Options:
A: N/A
B: Antipsychotic Efficacy (Day 43)
C: Change From Baseline In The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment (Baseline, Week 12/Early Termination (ET))
D: Change From Baseline to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score (From screening to week 12/early termination)

Answer: A