TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Hypothermia after delivery is a world-wide problem associated with morbidity and mortality. The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very preterm babies and represents the standard of care recommended by the International Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the proportions of hypothermic infants at NICU admission (temperature \<34°C) in the wrapped group (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The combination of body and head protection with a polyethylene wrap needs to be evaluated further. The investigators conducted a prospective, randomized, controlled trial in very preterm infants to evaluate whether a polyethylene total body wrapping (body plus head) prevents heat loss after delivery better than polyethylene occlusive wrapping.


Options:
A: Axillary temperature 36.5-37.5 degrees Celsius (1-4 hours)
B: Death to discharge or at six months corrected gestational age (discharge or six months corrected gestational age)
C: Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later
D: Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later. (Admission to the NICU)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Scientific Evaluation of the Nurse-Family Partnership (NFP) Program in British Columbia
Brief Summary: Nurse-Family Partnership (NFP) is a primary prevention program that was developed by Dr. David Olds in the United States (US) with the goal of helping vulnerable young first-time mothers and their children. The program involves public health nurses (PHNs) visiting mothers in their homes, providing intensive supports starting in pregnancy and continuing until children reach their second birthday. Studies in the US have shown that NFP significantly reduces child maltreatment and child behaviour problems, while also improving children's early learning and mother's economic self-sufficiency. Economic studies have also shown that the program pays for itself over the long-term. However, NFP has never been tested in Canada. Due to major differences in our populations and in our public services, we do not know whether NFP will show the same benefits here. We therefore plan to conduct a scientific evaluation of NFP's effectiveness in British Columbia (BC), in close collaboration with the BC government and BC's Health Authorities. Using randomized-controlled trial methods, NFP's effectiveness will be specifically evaluated in comparison with existing perinatal services in BC regarding outcomes across three fundamental domains: 1) pregnancy and birth; 2) child health and development; and 3) maternal health and life course. Findings from this evaluation will be used to improve the NFP program - to better meet the needs of vulnerable young mothers and their children in BC.


Options:
A: Average number of childhood injuries (2, 10, 18 and 24 months postpartum)
B: Initiation of LARC by time of standard postpartum visit (4-8 weeks postpartum)
C: Number of Participants With Implant Use at Three Months (Three months)
D: DSS Investigated and Substantiated Child Maltreatment Rates (0 - 12 Years of Child Age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to assess the feasibility of recruiting women with urinary incontinence into a randomized controlled trial of a yoga therapy program.


Options:
A: Change in the number of incontinent episodes (6 months)
B: Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks (6 weeks)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults
Brief Summary: A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC Synergy® and Catalyn® on cognitive and immune function markers and quality of life among healthy older adults with no history of significant cognitive deficits


Options:
A: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)
B: Cognitive Measures (6 months)
C: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)
D: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (baseline and 4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults
Brief Summary: A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC Synergy® and Catalyn® on cognitive and immune function markers and quality of life among healthy older adults with no history of significant cognitive deficits


Options:
A: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
B: Frequency of adverse events (baseline, monthly for 1 year, then 15 and 18 months)
C: Cognitive Measures (6 months)
D: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (baseline and 4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Physical Therapy on Pelvic Floor Symptoms and Quality of Life in Postpartum Women Following Severe Perineal Trauma: a Randomized Controlled Trial
Brief Summary: Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically in regard to anal incontinence. To be able to study this, the investigators need to know how well the muscles of a woman's pelvic floor function after a vaginal delivery and this requires measuring their strength during a pelvic exam. At present, there are no studies that have looked at whether the intervention of PT/BT improves a woman's anal incontinence quality of life after sustaining genital trauma during vaginal deliveries


Options:
A: Fecal Incontinence Quality of Life (FIQOL) (baseline (2-weeks post delivery) to completion (12-weeks post delivery))
B: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
C: Urinary Incontinence (Prevalence) (6 months postpartum (end of intervention))
D: Prematurity (Women will be interviewed at hospital soon after birth (up to 2 days after delivering))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Physical Therapy on Pelvic Floor Symptoms and Quality of Life in Postpartum Women Following Severe Perineal Trauma: a Randomized Controlled Trial
Brief Summary: Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically in regard to anal incontinence. To be able to study this, the investigators need to know how well the muscles of a woman's pelvic floor function after a vaginal delivery and this requires measuring their strength during a pelvic exam. At present, there are no studies that have looked at whether the intervention of PT/BT improves a woman's anal incontinence quality of life after sustaining genital trauma during vaginal deliveries


Options:
A: Fecal Incontinence Quality of Life (FIQOL) (baseline (2-weeks post delivery) to completion (12-weeks post delivery))
B: 24-hour Voiding Frequency (post-treatment (week 8))
C: Urinary incontinence score assessed with ICIQ-SF questionnaire (one year post partum)
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Physical Therapy on Pelvic Floor Symptoms and Quality of Life in Postpartum Women Following Severe Perineal Trauma: a Randomized Controlled Trial
Brief Summary: Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically in regard to anal incontinence. To be able to study this, the investigators need to know how well the muscles of a woman's pelvic floor function after a vaginal delivery and this requires measuring their strength during a pelvic exam. At present, there are no studies that have looked at whether the intervention of PT/BT improves a woman's anal incontinence quality of life after sustaining genital trauma during vaginal deliveries


Options:
A: UI reduction (12 months)
B: Difference in scores on a pelvic floor knowledge questionnaire at 6 weeks postpartum between intervention and control groups (At 6 weeks post-partum)
C: Fecal Incontinence Quality of Life (FIQOL) (baseline (2-weeks post delivery) to completion (12-weeks post delivery))
D: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer
Brief Summary: Description:

This is a multi-institutional study investigating the sensitivity and negative predictive value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or cervical cancer at the time of their robotic surgical staging.

Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine pathologic processing according to standard of care for these surgical procedures. The pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity and negative predictive value in their ability to detect metastatic disease.


Options:
A: Overall Survival (time from randomization until death)
B: Disease free survival (5 years from surgery)
C: Estimate the Sensitivity of the Sentinel Lymph Node (3 years)
D: Stage 1: Return to usual activities (12 months from surgery); Stage 2: Disease Free Survival (4.5 years from surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxytocin Antagonist in Patients With Repeated Failure of Implantation. A Prospective Randomized Placebo-controlled Double-blind Study.
Brief Summary: In this study the investigators compare the usual way of embryo transfer (without medication) with an embryo transfer while administering oxytocine antagonist. This to improve implantation and increase the pregnancy rate.


Options:
A: Live Birth (1 year)
B: implantation rate (4 weeks)
C: implantation rate (16 days from eggretrieval)
D: Pregnancy rates (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxytocin Antagonist in Patients With Repeated Failure of Implantation. A Prospective Randomized Placebo-controlled Double-blind Study.
Brief Summary: In this study the investigators compare the usual way of embryo transfer (without medication) with an embryo transfer while administering oxytocine antagonist. This to improve implantation and increase the pregnancy rate.


Options:
A: Clinical pregnancy rate (4 weeks after embryo transfer)
B: implantation rate (16 days from eggretrieval)
C: To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women (Vaginal ultrasound in pregnancy week 7)
D: Pregnancy rates (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Renal Sympathetic Denervation on Resistant Hypertension and Cardiovascular Hemodynamic in Comparison to Intensive Medical Therapy Utilizing Impedance Cardiography
Brief Summary: The purpose of this study is to demonstrate that Renal Sympathetic Denervation (RDN) improves the control of blood pressure (BP) in patients with treatment-resistant hypertension, as compared to intensive medical therapy (IMT) using hemodynamic parameters and then applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) during 6 months intensive treatment program (receiving antihypertensive care according to the 2007 ESH Guidelines). Working hypothesis: When it is possible to disrupt the sympatho-renal axis by RDN - BP reduction occurs to a greater extent and more rapidly than applying intensive medical therapy using IHM.


Options:
A: To provide confirmation that renal denervation is safe and feasible. (3 years)
B: Mean diurnal systolic blood pressure assessed by ABPM (Baseline to 6 months); Cost-effectiveness evaluation (1 year)
C: Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (From baseline to 6 months post-procedure)
D: Absolute change in office systolic blood pressure(SBP) (at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Renal Sympathetic Denervation on Resistant Hypertension and Cardiovascular Hemodynamic in Comparison to Intensive Medical Therapy Utilizing Impedance Cardiography
Brief Summary: The purpose of this study is to demonstrate that Renal Sympathetic Denervation (RDN) improves the control of blood pressure (BP) in patients with treatment-resistant hypertension, as compared to intensive medical therapy (IMT) using hemodynamic parameters and then applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) during 6 months intensive treatment program (receiving antihypertensive care according to the 2007 ESH Guidelines). Working hypothesis: When it is possible to disrupt the sympatho-renal axis by RDN - BP reduction occurs to a greater extent and more rapidly than applying intensive medical therapy using IHM.


Options:
A: Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP (from baseline to 2 months post procedure); Trio Cohort - Median Change in Daytime Ambulatory Systolic BP (from baseline to 2 months post procedure)
B: Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. (Through 3 years)
C: Absolute change in office systolic blood pressure(SBP) (at 6 months)
D: Mean diurnal systolic blood pressure assessed by ABPM (Baseline to 6 months); Cost-effectiveness evaluation (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Study to Evaluate the Effects of GSK1278863A on Pulmonary Artery Pressure in Healthy Volunteers
Brief Summary: This protocol is designed to explore whether short-term therapy with GSK1278863 affects PASP under normoxic and hypoxic conditions in healthy volunteers. Healthy subjects will be evaluated using echocardiography to estimate PASP based on the velocity of the tricuspid regurgitant jet. Resting PASP will be assessed under normoxic (room air) conditions, as well as after 30 minutes' exposure to 15% O2 before, during, and after short-term treatment with GSK1278863.


Options:
A: Placebo-adjusted change from baseline in PASP (estimated by transthoracic echocardiography) under normoxic conditions following 5 days of GSK1278863 (Day 5)
B: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
C: Survival without major amputation (6 months after implantation)
D: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy


Options:
A: Overall Survival (OS) in the TC3 or IC3-WT Populations (From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)); Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations (From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months))
B: Overall Survival (OS) (From date of randomization to date of death (assessed up to October 2019, approximately 23 months))
C: Overall survival (1-year)
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy


Options:
A: Overall survival (From ICF signature date until e until death date for any cause)
B: Progression-Free Survival (PFS) (Randomization to PD or death (up to 24 months))
C: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))
D: Overall Survival (OS) (From randomization up to death from any cause (up to approximately 55 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy


Options:
A: Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy (From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).); Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy (Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).)
B: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)
C: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy


Options:
A: Progression-Free Survival in Participants With PD-L1 Expression >= 5% (From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months))
B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
C: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))
D: Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1% (Up to approximately 44 months)

Answer: C