TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Fresh Embryo Transfers be Replaced by Cryopreserved-thawed Embryo Transfers in Assisted Reproductive Cycles?
Brief Summary: Cryopreservation of all embryos and transferring them subsequently in assisted reproductive technology (ART) cycles to improve outcome.


Options:
A: live birth rate (10 months for group A, 12 months for group B)
B: implantation rate (4 weeks)
C: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
D: Ongoing pregnancy (12 weeks of gestation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Fresh Embryo Transfers be Replaced by Cryopreserved-thawed Embryo Transfers in Assisted Reproductive Cycles?
Brief Summary: Cryopreservation of all embryos and transferring them subsequently in assisted reproductive technology (ART) cycles to improve outcome.


Options:
A: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
B: live birth rate (10 months for group A, 12 months for group B)
C: implantation rate (4 weeks)
D: Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) (Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Palliative Care for Quality of Life and Symptom Concerns in Early Stage Lung Cancer
Brief Summary: RATIONALE: Palliative care may be more effective than standard care in improving quality of life and symptoms in patients with lung cancer.

PURPOSE: This clinical trial is studying the effects of palliative care on quality of life and symptom control in patients with stage I, stage II, or stage IIIA non-small cell lung cancer that can be removed by surgery.


Options:
A: Overall quality of life and psychological distress (1 year after study enrollment); Symptom control (1 year after study enrollment); Geriatric assessment outcomes as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale (1 year after study enrollment); Resource use as measured by chart audits (1 year after study enrollment); Identification of subgroups of patients who benefit most from the palliative care intervention in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 12 (Week 12 after study enrollment)
B: length of stay hospital, intensive care unit and emergency admissions (1 year)
C: Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline (at baseline, 6 weeks and 12 weeks)
D: Change in patient's quality of living over time (baseline, 6,12,18,24,36 and every 12 weeks until death or end of study); Quality of end of life care (chart review at time of death and caregiver proxy interview 2-3 months after patient death); Estimate and compare the hazard ratios and median survival before and after 1 year from enrollment (From enrollment until patient death or end of study); Change in caregiver quality of life, burden and grief over time (baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled, Phase II, Double-Blind Trial of Intramyocardial Injection of Autologous Bone Marrow Mononuclear Cells Under Electromechanical Guidance for Patients With Chronic Ischemic Heart Disease and Left Ventricular Dysfunction
Brief Summary: Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. This study will determine the safety and effectiveness of withdrawing stem cells from someone's bone marrow and injecting those cells into the person's heart as a way of treating people with CAD and heart failure.


Options:
A: Change in Maximal Oxygen Consumption (VO2max) (Measured at Baseline and Month 6); Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo (Measured at Baseline and Month 6); Change in Reversible Defect Size (Measured at Baseline and Month 6)
B: Left ventricular ejection fraction at rest, measured six months postoperatively, measured by MRI
C: Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (one month post-catheterization)
D: Left ventricular ejection fraction at rest, measured by MRI (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavior and Exercise Versus Drug Treatment in Men With Nocturia
Brief Summary: Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy for LUTS in men, but α-blockers offer only limited reductions in nocturia. While combinations of multiple drugs could be used, many individuals wish to take fewer medications.

Participants in the BEDTiMe Nocturia Study will undergo a series of visits during which they will receive a combination of either standard drug therapy (or placebo) and a behavioral intervention tailored to help with nocturia or problems with nocturia. Participants will be evaluated for outcomes at 12 weeks and followed for six months.

This study will yield important information related to alternative treatments of nocturia in men, as well as novel information regarding the clinical importance of these nocturia reductions. This study has the potential to alter standards of care.


Options:
A: Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach (Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24)
B: Nocturia episodes (voiding diary) (12 weeks)
C: treatment failure (use of drug therapy for symptom control, surgical intervention, symptom deterioration of 3 points or more measured with the I-PSS, acute urinary retention, or death)
D: 24-hour Voiding Frequency (post-treatment (week 8))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial Comparing Intermittent Sedation and Daily Interruption of Sedation in Mechanically Ventilated Patients
Brief Summary: Sedation is very important in critical care. Critically ill patients are submitted to many stressor factors that have potential to affect longterm outcomes. However, oversedation is associated with increased morbidity, including increased time of mechanical ventilation and ICU stay and longterm psychological complications. Daily interruption of sedation is associated with less time under mechanical ventilation and less posttraumatic stress disorder. Intermittent sedation, when compared with continuous sedation, is also associated with decreased time of mechanical ventilation. The aim of this study is to compare intermittent sedation with daily interruption. Our primary endpoint is free-days of mechanical ventilation in 28 days.


Options:
A: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)
B: Ventilator free-days (28 days)
C: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
D: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial Comparing Intermittent Sedation and Daily Interruption of Sedation in Mechanically Ventilated Patients
Brief Summary: Sedation is very important in critical care. Critically ill patients are submitted to many stressor factors that have potential to affect longterm outcomes. However, oversedation is associated with increased morbidity, including increased time of mechanical ventilation and ICU stay and longterm psychological complications. Daily interruption of sedation is associated with less time under mechanical ventilation and less posttraumatic stress disorder. Intermittent sedation, when compared with continuous sedation, is also associated with decreased time of mechanical ventilation. The aim of this study is to compare intermittent sedation with daily interruption. Our primary endpoint is free-days of mechanical ventilation in 28 days.


Options:
A: Ventilator free-days (28 days)
B: Length of mechanical ventilation and ICU stay. Mortality
C: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
D: Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range; Time from ICU admission to discharge

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release
Brief Summary: This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.


Options:
A: Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set (Baseline and Week 14); Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol (Baseline and Week 14)
B: N/A
C: Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 (At Baseline and Week 12.)
D: Time to return to work (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Effects of Iron and Zinc Supplementation During Infancy on Cognitive Performance and Growth 8 Years Later: A Follow-Up Study
Brief Summary: The hypotheses of this study are:

1. Compared to children who received a placebo, children who received iron or zinc or iron and zinc combined will perform better on cognitive tests and will have better growth status at ages 8 to 10 years.
2. Compared to children who received iron or zinc alone, children who received iron and zinc combined will perform differently on cognitive tests and will have different growth status at 8 ages 8 to 10 years
3. Compared to children who had poorer iron and zinc status or poorer growth status before and after supplementation during infancy, children who had better iron and zinc status or better growth status before and after supplementation during infancy will perform better on cognitive tests and will have better growth status at ages 8 to 10 years.
4. Compared to children who have lower iron and zinc status, poorer growth status, or low animal source intake at ages 8 to 10 years, children who have higher iron and zinc status, better growth status, or high animal source intake at ages 8 to 10 years will perform better on cognitive tests and will have better growth status.


Options:
A: Linear growth velocity (6 to 18 months of age)
B: Death among children 1-36 months of age
C: IQ score (Aug 2007-Jan 2008)
D: proportion with treatment failures (Within 3 weeks after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term Effects of Iron and Zinc Supplementation During Infancy on Cognitive Performance and Growth 8 Years Later: A Follow-Up Study
Brief Summary: The hypotheses of this study are:

1. Compared to children who received a placebo, children who received iron or zinc or iron and zinc combined will perform better on cognitive tests and will have better growth status at ages 8 to 10 years.
2. Compared to children who received iron or zinc alone, children who received iron and zinc combined will perform differently on cognitive tests and will have different growth status at 8 ages 8 to 10 years
3. Compared to children who had poorer iron and zinc status or poorer growth status before and after supplementation during infancy, children who had better iron and zinc status or better growth status before and after supplementation during infancy will perform better on cognitive tests and will have better growth status at ages 8 to 10 years.
4. Compared to children who have lower iron and zinc status, poorer growth status, or low animal source intake at ages 8 to 10 years, children who have higher iron and zinc status, better growth status, or high animal source intake at ages 8 to 10 years will perform better on cognitive tests and will have better growth status.


Options:
A: IQ score (Aug 2007-Jan 2008)
B: Birth weight; 3-month infant mortality
C: To evaluate innate and adaptive immune response.; Future occurrence of acute diarrhoea, ARI and impetigo.
D: Fetal loss, low birth weight and pre-term birth. (Delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: REAL 3 : A Randomised Open-labelled Multicentre Trial of the Efficacy of Epirubicin, Oxaliplatin and Capecitabine (EOX) With or Without Panitumumab in Previously Untreated Advanced Oesophago-gastric Cancer
Brief Summary: To determine whether adding panitumumab, an antibody against the epidermal growth factor receptor (EGFR), to standard chemotherapy with epirubicin, oxaliplatin and capecitabine (EOX), improves the duration of survival of patients with advanced stomach and oesophageal cancer.


Options:
A: response (WHO criteria) (staging every 8 weeks)
B: Overall Survival (From randomization until death due to any cause (average of 51 weeks)); Overall Survival in All Randomized Participants (From randomization until death due to any cause (average of 51 weeks))
C: 6 Month Progression Free Survival (PFS) (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months)
D: Overall survival (Early termination)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: REAL 3 : A Randomised Open-labelled Multicentre Trial of the Efficacy of Epirubicin, Oxaliplatin and Capecitabine (EOX) With or Without Panitumumab in Previously Untreated Advanced Oesophago-gastric Cancer
Brief Summary: To determine whether adding panitumumab, an antibody against the epidermal growth factor receptor (EGFR), to standard chemotherapy with epirubicin, oxaliplatin and capecitabine (EOX), improves the duration of survival of patients with advanced stomach and oesophageal cancer.


Options:
A: Progression Free Survival (PFS) (22 months)
B: Progression free survival (PFS), as measured by RECIST per local review (Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.)
C: Overall survival (Early termination)
D: Overall Survival (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Detection and Classification of Colon Polyps: A Comparison of High Definition White Light and Narrow Band Imaging (Endoscopic Trimodal Imaging; ETMI)
Brief Summary: Colon cancer is the third most common cancer in western society. To prevent colon cancer it is recommended for people to undergo a screening colonoscopy at the age of fifty. The purpose of the colonoscopy is to remove polyps, since some of these lesions are precancerous. Precancerous polyps are called adenomas. This method of prevention is effective, but the standard colonoscopy currently used does not detect all polyps. Studies have reported a polyp miss rate of about 24%. Furthermore, we are unable to distinguish precancerous polyps from benign polyps, also known as hyperplastic polyps, with standard colonoscopy. This results in all polyps being removed at time of colonoscopy, even the benign polyps.

To help improve the detection of colon polyps new endoscopic technologies have been developed. These technologies include high definition white light (HDWL)and high definition narrow band imaging (HDNBI). HDWL improves the overall resolution of the images seen during colonoscopy. HDNBI can help us better classify polyps by enhancing their tissue appearance as well as seeing small blood vessels and capillaries.

The goal of this study to determine if HDNBI imaging shows an increased polyp detection rate when compared to the current standard colonoscopy. In addition to develop a classification system to help better differentiate between precancerous polyps and their benign counterparts using HDWL and HDNBI.


Options:
A: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.; The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.; The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).
B: 1. Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI (2 years)
C: Detection Rates for Adenomas and for Total Polyps (Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.)
D: adenoma detection rate for position 1 compared to position 2

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)
Brief Summary: The purpose of this study is to determine if Mindfulness Based Stress Reduction (MBSR) is an effective intervention for lowering blood pressure in early unmedicated hypertensives.


Options:
A: Perceived Stress Scale (PSS-10) scores (6 months)
B: Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52. (baseline and after 12 months); Changes from baseline in self-rated Health related quality of Life (36 item); The SF 36 - item short-form health status survey at week 52 (baseline and after 12 mounth); Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52 (baseline and after 12 months)
C: The primary outcome is the difference in 24-hour systolic and diastolic blood pressure between the treatment and wait-list group for the 12-week primary assessment period. (12 weeks)
D: Success meeting recruitment goals (20 patients within 3-4 months) (4-month recruitment window); Willingness to participate in study (>10% of eligible) (4-month recuitment window); Adherence rate (≥70% attendance, 7 of 10 classes) (12-weeks); Retention (≤25% drop-out) (6-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Practice-based Opportunities for Weight Reduction Trial at University of Pennsylvania
Brief Summary: The purpose of the study is to compare three methods of achieving weight loss in primary care medical practice. The study will be conducted in six primary care practices. Weight management will be provided to a total of 390 obese patients (who have 2 or more components of the metabolic syndrome) by their own primary care providers, in conjunction with the practices' auxiliary health professionals, including medical assistants.


Options:
A: Weight (Measured at Month 24)
B: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)
C: For adults: body weight loss maintenance (6 Month)
D: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Practice-based Opportunities for Weight Reduction Trial at University of Pennsylvania
Brief Summary: The purpose of the study is to compare three methods of achieving weight loss in primary care medical practice. The study will be conducted in six primary care practices. Weight management will be provided to a total of 390 obese patients (who have 2 or more components of the metabolic syndrome) by their own primary care providers, in conjunction with the practices' auxiliary health professionals, including medical assistants.


Options:
A: Change in Weight (Baseline to 30 months)
B: Number of Days the Subjects Are Adherent to Using Sunscreen (6 weeks)
C: Weight (Measured at Month 24)
D: Usual Gait Speed (Baseline); Usual Gait Speed (3 month); Usual Gait Speed (12-month); Rapid Gait Speed (Baseline); Rapid Gait Speed (3-month); Rapid Gait Speed (12-month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of the Dose of Erythropoiesis Stimulating Agents on Cardiac-cerebrovascular Outcomes Quality of Life and Costs in Hemodialysis Patients. The Clinical Evaluation of the DOSe of Erythropoietins (C.E. DOSE) Trial
Brief Summary: Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESAs) are the most used treatment option.

The purpose of this study is

1. the evaluation of biochemical markers to determine the efficacy of individual prediction of ESAs therapy
2. to determine the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).


Options:
A: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
B: Mean Hb Change Level During the Last Four Weeks of Treatment (Week 22 to week 26); Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment (Week 22 to week 26)
C: Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33) (Baseline Week 33)
D: TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein (after randomization at month 1, 2, 3, 6, 12)

Answer: D