TrialPanorama/Dataset huggingface dataset:
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: Medication Event Monitoring System (MEMS®) Dosage Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)); Medication Event Monitoring System (MEMS®) Regimen Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)); Medication Event Monitoring System (MEMS®) Time Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks))
B: Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase (2, 4, 8, 10, 12 and 14 hours post-dose on Day 7)
C: Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Trial of Phenylbutyrate/Genistein Duotherapy in Delta F508-Homozygous Cystic Fibrosis Patients
Brief Summary: We are testing a new combination of medicines, to determine if they could be used to treat cystic fibrosis (CF). Subjects with CF who have two copies of the most common mutation (change) found in patients with CF called DF508. CF is caused by a lack of chloride movement in the nose, sinuses, lungs, intestines, pancreas and sweat glands. We are conducting this study to determine the safety of using a combination of two medicines, Phenylbutyrate and Genistein, to improve the ability of the cells lining the nose to regulate movement of salt (chloride) and water in people with CF.

Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases (which are very different from CF), Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. Both drugs may be able to restore normal chloride movements in body organs and glands. We will be studying salt and water in the nose movement by a technique called nasal transepithelial potential difference (NPD).


Options:
A: Safety and Tolerability Based on Adverse Events (AEs) (Up to 14 days after last dose (last dose = Day 28))
B: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)
C: The basis of analysis for the primary outcome measure will be the comparison of data from both the standard CF NPD protocol compared to a modified NPD protocol including the perfusion of Genistein. (All visits)
D: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events. (28 Days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Trial of Phenylbutyrate/Genistein Duotherapy in Delta F508-Homozygous Cystic Fibrosis Patients
Brief Summary: We are testing a new combination of medicines, to determine if they could be used to treat cystic fibrosis (CF). Subjects with CF who have two copies of the most common mutation (change) found in patients with CF called DF508. CF is caused by a lack of chloride movement in the nose, sinuses, lungs, intestines, pancreas and sweat glands. We are conducting this study to determine the safety of using a combination of two medicines, Phenylbutyrate and Genistein, to improve the ability of the cells lining the nose to regulate movement of salt (chloride) and water in people with CF.

Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases (which are very different from CF), Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. Both drugs may be able to restore normal chloride movements in body organs and glands. We will be studying salt and water in the nose movement by a technique called nasal transepithelial potential difference (NPD).


Options:
A: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
B: The basis of analysis for the primary outcome measure will be the comparison of data from both the standard CF NPD protocol compared to a modified NPD protocol including the perfusion of Genistein. (All visits)
C: The sum of responses in nasal potential difference (NPD) after perfusion with isoproterenol and chloride-free buffer (TCS: Total Chloride Secretion), in the presence of amiloride. (Change from baseline (pre-dose on Day 1) to end-of-treatment (Day 8))
D: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline up to Week 100)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane Versus a Non Taxane Regimen
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient.

PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient.


Options:
A: Progression-Free Survival (PFS) Time (Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression)
B: Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.
C: The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism
D: Progression-free survival (from randomization till first evidence of progression)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU Versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known whether radiation therapy and carmustine are more effective with or without O6-benzylguanine.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed glioblastoma multiforme or gliosarcoma.


Options:
A: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)
B: Overall survival (12 months)
C: Progression Free Survival (PFS) time (5 years)
D: Survival (assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuroblastoma Study Phase II Study of Various Therapies in Patients With Neuroblastoma
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Combining these therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with or without peripheral stem cell transplantation in treating patients who have neuroblastoma.


Options:
A: 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)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuroblastoma Study Phase II Study of Various Therapies in Patients With Neuroblastoma
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Combining these therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with or without peripheral stem cell transplantation in treating patients who have neuroblastoma.


Options:
A: N/A
B: Event-Free Survival (EFS) (Three years)
C: N/A
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Trial Of IM862 Combined With Paclitaxel And Carboplatin In Newly Diagnosed Advanced Epithelial Ovarian Or Primary Peritoneal Carcinoma Followed By IM862 Consolidation Therapy
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.


Options:
A: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
B: N/A
C: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)
D: investigator-determined progression-free survival (every 12 weeks until progression or up to 30 months (whichever occurs first))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Trial Of IM862 Combined With Paclitaxel And Carboplatin In Newly Diagnosed Advanced Epithelial Ovarian Or Primary Peritoneal Carcinoma Followed By IM862 Consolidation Therapy
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.


Options:
A: N/A
B: Overall survival (OS) (This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled)
C: 2-year Progression-free Survival (2 years)
D: objective response rate (24month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
B: N/A
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: All strokes (fatal and non-fatal) (Duration of trial)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI (Continuous monitoring (24 hours loop recording)); Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure (Continuous monitoring (24 hours loop recording))
B: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
C: Freedom from AF (18 months)
D: Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. (From date of enrollment until time-to-first event over a median follow-up of 48.5 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: 24 hour blood pressure (12 weeks)
B: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
C: Glycemic Control (0 and 4 months)
D: Change of intrahepatic triglyceride contents (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: Weight loss (6 months)
B: area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; HbA1C at baseline, 3 months and 6 months; weight at baseline, 3 months and 6 months; waist circumference at baseline, 3 months and 6 months
C: Weigtreduction; Increase in maximum oxygen uptake; Change in foodintake; Change in self-reported activity
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
B: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
C: Achievement of the target office blood pressure (< 140/90 mmHg) (6 months); Achievement of the target systolic office blood pressure (< 140 mmHg) (6 months); Achievement of the target diastolic office blood pressure (< 90 mmHg) (6 months)
D: Change in global neurocognitive function (2 Years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
B: hemoglobin A1C (diabetes management) (assessment at baseline (0 weeks)); hemoglobin A1C (diabetes management) (assessment at 10 weeks); hemoglobin A1C (diabetes management) (assessment at 20 weeks); hemoglobin A1C (diabetes management) (assessment at one-year follow-up); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at baseline (0 weeks)); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at 10 weeks); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assesment at 20 weeks); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at one-year follow-up); body weight (assessment at baseline (0 weeks)); body weight (assessment at 10 weeks); body weight (assessment at 20 weeks); body weight (assessment at one-year follow-up); indices of renal function (serum creatinine, microalbumin) (assessment at baseline (0 weeks)); indices of renal function (serum creatinine, microalbumin) (assessment at 10 weeks); indices of renal function (serum creatinine, microalbumin) (assessment at 20 weeks); indices of renal function (serum creatinine, microalbumin) (assessment at one-year follow-up)
C: Hemoglobin A1c (22 weeks)
D: total and low-density lipoprotein (LDL) cholesterol; LDL:HDL cholesterol ratio; weight reduction

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: Mean Weight (Weekly/Monthly, up to 1 year); Change in Predicted Trajectory of Mean BMI Per GLMM Analysis (12 months); Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis (12 months)
B: BMI (11 months)
C: Change in Weight (Baseline, 3-, 6-, 9-, 12-, and 18-months)
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: Placental weight (At delivery); Fetal birth weight (At delivery); Change from baseline in maternal gestational weight (38-42 weeks of gestation)
B: Fecal Incontinence Quality of Life (FIQOL) (baseline (2-weeks post delivery) to completion (12-weeks post delivery))
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Predomination of type of birth, operative vaginal delivery versus natural spontaneous vaginal delivery (At time of delivery (~6 months after baseline)); Indication for operative vaginal delivery (if applicable) (At time of delivery (~6 months after baseline))

Answer: C