TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer
Brief Summary: A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the compatibility of the TPF-induction without decreasing the efficacy the dose will be given on day 1 and 8 instead of applying the whole dose on day 1 every 3 weeks.

In the phase I-part of the trial the optimal therapeutic dose of Docetaxel and Cisplatin will be defined.

In the phase II-part the progression-free survival after 2 years will be assessed in patients treated with the optimal therapeutic dose.


Options:
A: N/A
B: Efficacy (18 weeks)
C: Determination of progression-free survival after 2 years (24 months)
D: Overall Survival (3-years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Virtual Ward to Reduce Readmissions After Hospital Discharge
Brief Summary: The purpose of this study is to see whether a Virtual Ward reduces readmissions after hospital discharge.


Options:
A: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
B: Composite of readmission to hospital or death. (30 days after hospital discharge)
C: acute care utilization (90 days)
D: Failure to persist with medication regimen (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Virtual Ward to Reduce Readmissions After Hospital Discharge
Brief Summary: The purpose of this study is to see whether a Virtual Ward reduces readmissions after hospital discharge.


Options:
A: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
B: functional gain as measured by motor FIM score (One year post team training intervention)
C: Composite of readmission to hospital or death. (30 days after hospital discharge)
D: Patient Health Questionaire (PHQ-9) (At 3- and 6- months following the death of the patient)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Oxytocin Initiative: Determining the Effect of Prophylactic Administration of Oxytocin in Uniject™ by a Community Health Officer on Postpartum Hemorrhage at Home Births in Four Districts in Ghana
Brief Summary: This study is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO) at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative to home births attended by the same type of provider who does not provide a uterotonic drug.


Options:
A: postpartum hemorrhage-1 (after delivery of baby); postpartum hemorrhage-2 (after delivery of the baby); postpartum hemorrhage-3 (after delivery of the baby)
B: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)
C: postpartum bleeding in the third stage of labour (participants will be followed for the duration of hospital stay, an expected average of 48 hours)
D: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (baseline to discharge (2 - 3 days)); Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage (Initial hospital discharge (2-3 days)); Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors (baseline to discharge (2-3 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Oxytocin Initiative: Determining the Effect of Prophylactic Administration of Oxytocin in Uniject™ by a Community Health Officer on Postpartum Hemorrhage at Home Births in Four Districts in Ghana
Brief Summary: This study is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO) at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative to home births attended by the same type of provider who does not provide a uterotonic drug.


Options:
A: the amount of blood loss in third and fourth stages of labor (The end of the delivery to 2 hours after birth.)
B: Maximal uterine tone (within the first 5 minutes after cord clamping)
C: postpartum hemorrhage-1 (after delivery of baby); postpartum hemorrhage-2 (after delivery of the baby); postpartum hemorrhage-3 (after delivery of the baby)
D: Mean change in hemoglobin (during 3rd trimester and 1-3 days postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Oxytocin Initiative: Determining the Effect of Prophylactic Administration of Oxytocin in Uniject™ by a Community Health Officer on Postpartum Hemorrhage at Home Births in Four Districts in Ghana
Brief Summary: This study is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO) at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative to home births attended by the same type of provider who does not provide a uterotonic drug.


Options:
A: postpartum hemorrhage-1 (after delivery of baby); postpartum hemorrhage-2 (after delivery of the baby); postpartum hemorrhage-3 (after delivery of the baby)
B: screening of Cessation of bleeding (screening until 24 hours after placenta disconnection); time duration to stop bleeding in the case of post-cesarean section (24 hours)
C: Amount of bleeding (1 hour)
D: Need for Additional Uterotonic Medications (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hygienists Internet Tobacco Cessation Study (HiQuit)
Brief Summary: Our overall goal is to advance science related to using the Internet in health services delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed intervention is the first Internet-delivered intervention to target the dental microsystem for smoking cessation-providing access to hygienists and patients.


Options:
A: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
B: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)
C: Smoking Abstinence (12 months); Treatment Utilization for Smoking Cessation (12 months)
D: Number of smokers referred to tobacco cessation website (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Hygienists Internet Tobacco Cessation Study (HiQuit)
Brief Summary: Our overall goal is to advance science related to using the Internet in health services delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed intervention is the first Internet-delivered intervention to target the dental microsystem for smoking cessation-providing access to hygienists and patients.


Options:
A: being a smoker (29 years)
B: Number of smokers referred to tobacco cessation website (12 months)
C: Point prevalence abstinence
D: Knowledge about hazards of smokeless tobacco (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Hygienists Internet Tobacco Cessation Study (HiQuit)
Brief Summary: Our overall goal is to advance science related to using the Internet in health services delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed intervention is the first Internet-delivered intervention to target the dental microsystem for smoking cessation-providing access to hygienists and patients.


Options:
A: to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients; exhaled carbon monoxide testing; and plasma cotinine measurements
B: Number of smokers referred to tobacco cessation website (12 months)
C: 7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8) (8 weeks)
D: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Afinitor (RAD001) vs. Sutent (Sunitinib) in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma (ASPEN)
Brief Summary: To compare the anti-tumor activity of everolimus and sunitinib in subjects with metastatic renal cell carcinoma (mRCC) with non-clear cell pathology.


Options:
A: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.)
B: Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 (From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)); Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)); Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months))
C: Anti-tumor Activity as Measured by Median Progression Free Survival Time (24 Months)
D: Progression Free Survival (PFS) (Randomization to Measured Progressive Disease or Date of Death From Any Cause (Up to 67 Months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Afinitor (RAD001) vs. Sutent (Sunitinib) in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma (ASPEN)
Brief Summary: To compare the anti-tumor activity of everolimus and sunitinib in subjects with metastatic renal cell carcinoma (mRCC) with non-clear cell pathology.


Options:
A: Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years))
B: Anti-tumor Activity as Measured by Median Progression Free Survival Time (24 Months)
C: Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab (Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.)
D: Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS) (Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)); Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS) (2 cycles (e.g., one cycle = 28 days)); Number of Participants With a Best Observed Response (Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)); Number of Participants With a Best Response (Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Milnacipran or Placebo on Ventricular Lactate Levels and Fibromyalgia Induced "Brain Fog."
Brief Summary: Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.


Options:
A: Change in Ventricular Lactate Levels in the Brain (Baseline and 2 months)
B: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
C: Global Clinical Improvement Scale (After 13 weeks)
D: MRI-derived Percentage Brain Volume Change (PBVC). (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Milnacipran or Placebo on Ventricular Lactate Levels and Fibromyalgia Induced "Brain Fog."
Brief Summary: Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.


Options:
A: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)
B: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)
C: Change in Ventricular Lactate Levels in the Brain (Baseline and 2 months)
D: Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 (4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)); Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6 (7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: Objective: Chronic obstructive pulmonary disease (COPD) is a disease with significant morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital admissions related to COPD is the single largest source of expenditure in the public hospital system. This study aims to assess whether a comprehensive care programme can decrease the rate of hospital admissions for COPD patients.


Options:
A: Hospital Readmission (12 months)
B: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)
C: inflammatory cytokines (6 months); C-reactive protein (CRP) (6 months); Incremental shuttle walk test (ISWT) (6 months); spirometry (6 months); strength of limb muscles (6 months)
D: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: Objective: Chronic obstructive pulmonary disease (COPD) is a disease with significant morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital admissions related to COPD is the single largest source of expenditure in the public hospital system. This study aims to assess whether a comprehensive care programme can decrease the rate of hospital admissions for COPD patients.


Options:
A: Total cost of hospitalization, $ (Day of admission to day of discharge)
B: Self-management and Activation (6 Months)
C: Improvement tolerance capacity (4 months and 6 months)
D: Hospital Readmission (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: Objective: Chronic obstructive pulmonary disease (COPD) is a disease with significant morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital admissions related to COPD is the single largest source of expenditure in the public hospital system. This study aims to assess whether a comprehensive care programme can decrease the rate of hospital admissions for COPD patients.


Options:
A: Hospital Readmission (12 months)
B: Changes in EQ ED From Baseline to 3 Months Endpoint (Baseline and change at 3 months); Changes in the Symptom Burden of Disease From Baseline to 3 Months (Baseline with change at 3 months); Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint (Baseline and change at 3 months); Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint (Baseline and change at 3 months)
C: Quadriceps Muscle Strength Testing Change (measured at baseline and at ten weeks); Six Minute Walk Test (measured at baseline and at ten weeks); Health-related Quality of Life Assessments Change (measured at baseline and ten weeks); Participant Satisfaction Survey (measured at ten weeks (study completion))
D: Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm (Measured at 6 months post 'index-hospitalization'); Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm (Baseline to 6 months post index-hospitalization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: Objective: Chronic obstructive pulmonary disease (COPD) is a disease with significant morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital admissions related to COPD is the single largest source of expenditure in the public hospital system. This study aims to assess whether a comprehensive care programme can decrease the rate of hospital admissions for COPD patients.


Options:
A: Non-outpatient COPD related hospital attendance (A+E attendance, inpatient admission or death) (3-months)
B: Change from baseline in dyspnea at 4th day (At baseline and at the 4th day of the study)
C: Hospital Readmission (12 months)
D: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The GORE VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Versus Plain Old Balloon Angioplasty (POBA) for the Treatment of Superficial Femoral Artery (SFA) In-Stent Restenosis
Brief Summary: This is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L. Gore \& Associates), a heparin-bonded endoprosthesis, is compared with plain old balloon angioplasty (POBA). In 4 Belgian and 2 German centers a total of 80 Patients will be recruited. Primary endpoint is primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and without target lesion revascularization (TLR) within 12 months.

In comparison to POBA, it is expected that the use of the Viabahn endoprosthesis (W.L. Gore \& Associates) will result in greater 12 month primary patency of treated superficial femoral artery in-stent restenotic lesions.


Options:
A: angiographic binary re-restenosis (12 months)
B: Percentage diameter stenosis (6 months)
C: primary patency rate (6 months)
D: Primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) and without target lesion revascularization (TLR) within 12 months. (1 year); Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a common condition associated with major disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire \[CRQ\] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.


Options:
A: change in St. George's Respiratory Questionnaire (SGRQ) (14 weeks after intervention)
B: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
C: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)
D: Walking time in daily life and the amount of time spent in moderate intense activities

Answer: B