TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Brief Summary: The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.


Options:
A: Progression-Free Survival (PFS) (Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months))
B: 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)
C: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
D: Overall Survival (OS) (Up to 4.3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia
Brief Summary: Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator


Options:
A: Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration. (Up to 18 Month Visit-End of Study)
B: frequency of epileptic seizures (Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures)
C: Summary of Seizures Reported by Investigators and Triple Review (Epilepsy Monitoring Unit Stay); Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting (Epilepsy Monitoring Unit (EMU) Stay); Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant (Epilepsy Monitoring Unit (EMU) Stay); Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting (Epilepsy Monitoring Unit (EMU) Stay)
D: Changes in seizure frequency (12 weeks of stimulation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Brief Summary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).


Options:
A: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days)
B: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)
C: Overall Objective Response (1 year after end inclusion)
D: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Brief Summary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).


Options:
A: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days)
B: Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) (3 years)
C: Progression-Free Survival (The timeframe is from enrollment onto the study up to 3 years following enrollment.)
D: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Brief Summary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).


Options:
A: Progression free survival (PFS) (4 months)
B: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (Week 24)
C: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days)
D: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Brief Summary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).


Options:
A: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days)
B: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
C: Complete response rate (average 24 months)
D: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Brief Summary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).


Options:
A: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days)
B: Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) (Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.)
C: Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) (At 28 days); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) (At 28 Days); Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) (Time from start of treatment to time of objective disease progression, assessed up to 5 years); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). (At 28 days)
D: To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 (assessed at each visit)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
Brief Summary: One of the essential treatments for assisting patients in their recovery from illness is the provision of nutrition in a liquid form which is delivered into the stomach or as a fluid into the vein. Until recently the benefits of nutrition were undervalued in the critically ill, however, it has now become clear that targeted nutrition can positively affect a person's outcome. This is particularly important for patients who are significantly unwell and require increased amounts of nutrition to support recovery. Inadequate nutrition therapy leads them to rapidly lose weight, predominantly in the form of muscle loss which greatly contributes to their poor recovery.

Whilst nutrition is essential for recovery, there are several issues with the delivery of nutrition via the stomach (the most commonly used method of delivering nutrition in the critically ill). For many reasons, patients are unable to tolerate large quantities of nutrition via the stomach and in addition to this there are hospital or procedural reasons for nutrition being turned off for lengthy periods of time. As such, this results in patients being delivered only about half of the nutrition that is planned. One potential way to overcome this is to deliver nutrition via the vein, whilst nutrition into the stomach continues, with the aim to meet the energy gap that is lost by inadequate nutrition via the stomach.

In this study of 100 patients, we will deliver combined nutrition via the vein and stomach in 50 patients and the other 50 patients will receive nutrition as per normal practice. We will measure important outcomes for these patients to determine if this allows us to meet significantly more of their nutrition needs. This study will also help us determine how best to design a larger study of this strategy.


Options:
A: Total energy amount delivered (First 7 days of the study period)
B: Length of stay in ICU and length of stay in the hospital. (2 years)
C: Calorie & Protein Intake 7 Days Post Randomization (7 days post randomization); Calorie & Protein Intake in First 27 Days (first 27 days)
D: Physical function (6 months after randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Multi-centric Open Label Clinical Trial to Determine the Efficacy and Toxicity of Preoperative Chemotherapy With or Without Bevacizumab in Patients With Advanced Ovarian Cancer
Brief Summary: Recently results have shown that Bevacizumab is active both in monotherapy and in combination therapy in patients with ovarian cancer. One of our objectives is to evaluate whether the addition of neoadjuvant bevacizumab improves the response and whether this affects the evolution of patients.


Options:
A: objective response rate (one year)
B: Complete response rate (average 24 months)
C: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
D: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Multi-centric Open Label Clinical Trial to Determine the Efficacy and Toxicity of Preoperative Chemotherapy With or Without Bevacizumab in Patients With Advanced Ovarian Cancer
Brief Summary: Recently results have shown that Bevacizumab is active both in monotherapy and in combination therapy in patients with ovarian cancer. One of our objectives is to evaluate whether the addition of neoadjuvant bevacizumab improves the response and whether this affects the evolution of patients.


Options:
A: Proportion of patients with objective response rate with recurrent endometrial cancer with mutated ARID1A (3 years); Proportion of patients with objective response rate with recurrent ovarian cancer with mutated ARID1A (3 years)
B: Efficacy by progression free survival (PFS1) (phase up to a total of 15 months)
C: Progression Free Survival (PFS) (Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years)
D: Complete response rate (average 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer
Brief Summary: This study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.


Options:
A: Number of harvested lymph nodes (2 years)
B: Duration of Surgery (after surgey)
C: Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy (6 Weeks)
D: Number of lymph nodes (After aortic lymphadenectomy is completed)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: EMDR Treatment for Psychological Trauma Among Syrian Refugees in Kilis, Randomized Controlled Trial.
Brief Summary: To implement an EMDR (Eye Movement Desensitization and Reprocessing)intervention to treat the trauma symptoms among Syrian Refugees.


Options:
A: Depression (10-16 weeks); Posttraumatic Stress Symptoms (10-16 weeks)
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: score on Harvard Trauma Questionnaire (at the main study) (before and after the treatment,an expected average of 7 weeks of EMDR treatment); Impact of Event Scale Revised (at the pilot study and the main study) (pre- and post treatment)
D: depression (pre, post and 6 months post treatment)

Answer: C