TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of a Home-based Physical Activity Intervention in Breast Cancer Survivors
Brief Summary: The aim of this current study was to investigate the effects of a pragmatic home-based physical activity programme on primarily physical activity levels and secondarily weight maintenance, health-related quality of life (HRQoL), insulin resistance (IR) and lipid concentrations in post-adjuvant therapy breast cancer survivors.


Options:
A: psychosocial well-being (as assessed by the EORTC-QLQ C30 Quality of life core questionnaire by the European Organization of Research and Treatment in Cancer (EORTC-QLQ C30) and the Profile of Mood States Short form (POMS-SF) (baseline, 1 month follow-up, 6 month follow-up, 12 month follow-up)
B: Physical activity questionnaire (International Physical Activity Questionnaire) (Baseline and 6 months)
C: Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) (Baseline to up to 6 months); Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months); Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months)
D: Patient perception and pattern of change (3 months of training followed by 6 and 12 months of no formal training)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of a Home-based Physical Activity Intervention in Breast Cancer Survivors
Brief Summary: The aim of this current study was to investigate the effects of a pragmatic home-based physical activity programme on primarily physical activity levels and secondarily weight maintenance, health-related quality of life (HRQoL), insulin resistance (IR) and lipid concentrations in post-adjuvant therapy breast cancer survivors.


Options:
A: Change in FACIT-TS questionnaire score (Baseline, 6 months)
B: Physical activity questionnaire (International Physical Activity Questionnaire) (Baseline and 6 months)
C: Menopausal symptoms (6 months)
D: To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (Baseline); To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (8 weeks); To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium
Brief Summary: The primary objective of this study is to compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at greater than or equal to 37+ 0 completed weeks gestation. Thus, the investigators have both efficacy and a safety primary outcomes.

The secondary objective of this study is to assess the pharmacokinetic(PK) parameters with these two routes of administration in a sub-cohort of this trial. The long term objective of this line of research is to inform providers' clinical decision making for the large number of women having labor induction. By providing robust PK and pharmacodynamic (PD) evaluation, clinical outcomes data for these two routes of administration, clinicians will be informed for evidence-based decisions about the preferred route of administration of misoprostol.


Options:
A: Vaginal delivery (24 hours); Hyperstimulation syndrome (24 hours); Cesarean section (3 days); Severe neonatal morbidity or perinatal death (28 days); Serious maternal morbidity or maternal death (42)
B: Time to Active Labor (from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.)
C: induction delivery time (2 hourly)
D: Time to Delivery (from study entry until delivery- anticipated 3 days); Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications (from study entry until delivery- anticipated 3 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis
Brief Summary: The purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with Multiple Sclerosis.


Options:
A: Clinical assessment procedures: - Berg Balance Scale (BBS) - Activities-specific Balance Confidence Scale (ABC) Instrumental assessment procedures: - Stabilometric assessment (At recruitment, after treatment (5 weeks) and in the follow-up (1 month))
B: Change from Baseline in Bergs balance scale (Change from Baseline in Bergs balance scale at 7 weeks)
C: Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months (At baseline, 1 week after completion of training, 3 months later); Change from Baseline in Falls at Completion of Training and the Following Three Months (First week of training, last week of training, 3 months later); Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training (At baseline, 1 week after completion of training)
D: Difference in mean change in total falls between intervention and control arms (5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
Brief Summary: Young infants are most vulnerable to severe disease and even death when infected with Bordetella pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates from this disease. Maternal acquired pertussis-specific antibodies show low concentrations with short persistence in newborns creating a susceptibility gap for infection between birth and the first vaccinations. A possible strategy to protect infants from birth is pertussis vaccination during pregnancy, which will increase the amount of passively transferred maternal antibodies.

However, little is known regarding the effect of high titers of maternal antibodies on the infants immune responses to different pertussis vaccines (whole cell versus acellular). Humoral immune responses will be assessed in infants receiving whole cell versus infants receiving acellular pertussis vaccines. Functionality of the antibodies will also be analyzed.


Options:
A: Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. (Day 0 up to Day 7 post-injection)
B: kinetics of Pertussis toxin (PT) IgG titers in infants (from birth until 19 months of age); kinetics of Filamentous haemagglutinin (FHA) IgG titers in infants (from birth until 19 months of age); kinetics of Pertactin (Prn) IgG titers in infants (from birth until 19 months of age)
C: Diagnosis of IgE-mediated food allergy (birth-15 years)
D: Phase A - Inoculum Dose Determination (Up to volunteer visit Day 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer
Brief Summary: This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.


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: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Up to approximately 19 months); Overall Survival (OS) (Up to approximately 19 months)
C: Percentage of Participants Who Died: PP-ITT (Baseline until death due to any cause (up to approximately 2.25 years)); Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP (Baseline until death due to any cause (up to approximately 2.25 years)); Overall Survival (OS): PP-ITT (Baseline until death due to any cause (up to approximately 2.25 years)); OS: TC1/2/3 or IC1/2/3 Subgroup of PP (Baseline until death due to any cause (up to approximately 2.25 years)); OS: SP-ITT (Baseline until death due to any cause (up to approximately 2.87 years)); OS: TC1/2/3 Or IC1/2/3 Subgroup of SP (Baseline until death from any cause (approximately 2.87 years)); OS: TC2/3 or IC2/3 Subgroup of SP (Baseline until death due to any cause (up to approximately 2.87 years)); OS: TC3 or IC3 Subgroup of SP (Baseline until death due to any cause (up to approximately 2.87 years))
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer
Brief Summary: This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.


Options:
A: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)
B: Progression Free Survival (PFS) Rate at Month 6 (Month 6)
C: 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))
D: 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))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer (Ferric Carboxymaltose) in the Treatment of Iron Deficient Patients With Fibromyalgia
Brief Summary: This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of iron deficient patients with fibromyalgia. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 42 days.


Options:
A: Proportion of Patients With a ≥13 Point Improvement in FIQR Score (Day 42)
B: Change in pulmonary artery systolic pressure (One week (SLR arm) and one month (CMS arm))
C: Iron bio-availability (%) from oral iron supplementation (3x 120 mg) (3 days); Serum hepcidin concentrations on the 1st day of iron supplementation (1 day); Iron bio-availability (%) from oral iron supplementation (6x 60 mg) (6 days); Serum hepcidin concentrations on the 2nd day of iron supplementation (2 days); Serum hepcidin concentrations on the 3rd day of iron supplementation (3 days); Serum hepcidin concentrations on the 4th day of iron supplementation (4 days); Serum hepcidin concentrations on the 5th day of iron supplementation (5 days); Serum hepcidin concentrations on the 6th day of iron supplementation (6 days)
D: Incidence of severe adverse drug reactions (ADRs) (Immediate - during infusion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Of Intensive Versus Minimal Surveillance Of Patients With Resected Dukes B2-C Colorectal Carcinoma
Brief Summary: Dukes B2-C colorectal cancer patients who had no evidence of disease at the end of their front line treatment (surgery and adjuvant radio-chemotherapy, if indicated) are eligible for the trial and randomized to two different surveillance programs. These programs differ greatly in the frequency of diagnostic imaging. They have similar schedules of physical examinations and carcinoembryonic antigen (CEA) assessments. Patients will receive baseline and yearly health-related quality of life (HR-QoL) questionnaires. Primary outcomes are overall survival and QoL.


Options:
A: Overall Survival (OS) (5-year OS); Health Related Quality of Life (Yearly assessment over 5 years)
B: Patient in receipt of a complete survivorship care plan (16 weeks)
C: Change in FACIT-TS questionnaire score (Baseline, 6 months)
D: The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative (Baseline); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive (Baseline); The Expanded Prostate Cancer Index (EPIC) - Bowel Health (Baseline); The Expanded Prostate Cancer Index (EPIC) - Sexual Health (Baseline); The Expanded Prostate Cancer Index (EPIC) - General Health (Baseline); The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean (Baseline); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative (5 Months); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive (5 Months); The Expanded Prostate Cancer Index (EPIC) - Bowel Health (5 Months); The Expanded Prostate Cancer Index (EPIC) - Sexual Health (5 Months); The Expanded Prostate Cancer Index (EPIC) - General Health (5 Months); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative (12 Months); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive (12 Months); The Expanded Prostate Cancer Index (EPIC) - Bowel Health (12 Months); The Expanded Prostate Cancer Index (EPIC) - Sexual Health (12 Months); The Expanded Prostate Cancer Index (EPIC) - General Health (12 Months); Confidence in Symptom Self-Management (5 months); Confidence in Symptom Self-Management (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Of Intensive Versus Minimal Surveillance Of Patients With Resected Dukes B2-C Colorectal Carcinoma
Brief Summary: Dukes B2-C colorectal cancer patients who had no evidence of disease at the end of their front line treatment (surgery and adjuvant radio-chemotherapy, if indicated) are eligible for the trial and randomized to two different surveillance programs. These programs differ greatly in the frequency of diagnostic imaging. They have similar schedules of physical examinations and carcinoembryonic antigen (CEA) assessments. Patients will receive baseline and yearly health-related quality of life (HR-QoL) questionnaires. Primary outcomes are overall survival and QoL.


Options:
A: Overall and cancer-specific mortality (5 years)
B: Percentage of patients with a non removable recurrence (at the end of the study)
C: Overall survival rate (5 years)
D: Overall Survival (OS) (5-year OS); Health Related Quality of Life (Yearly assessment over 5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
Brief Summary: Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth. However, this possibility needs to be proven in a properly designed randomized controlled trial (RCT) with preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and geographically diverse population could best be accomplished by the established infrastructure of the Global Network for Women's and Children's Health Research (GN).


Options:
A: Live Birth (after delivery)
B: Preeclampsia - Change in blood pressure (Hypertension) (From 20 weeks gestation to delivery); Preeclampsia - Change in Proteinuria (From 20 weeks gestation to birth); Birth weight (weight will be measured on the day of birth and plotted on standard WHO UK RCPCH growth charts (per gender).); Preterm birth (Gestational age at birth will be verified with respect to the Estimated Date of Delivery calculated at the first study visit.); Perinatal mortality (Stillbirth or neonatal death after 24 completed weeks of gestation and within 28 days of birth.)
C: The proportion of eligible women that agree to participate in the study (Throughout study completion, less than 40 weeks); Adherence to aspirin if prescribed (36 weeks); The proportion of study subjects in whom it is possible to obtain first trimester trans-abdominal uterine artery Doppler examination (36 weeks); The proportion of study subjects with a completed screening test who are issued the screening result within one week of having the test performed (1 week); Attendance at study visits (36 weeks); Satisfactory collection of all endpoints and variables (36 weeks); Any specific study protocol violations (36 weeks)
D: Incidence of Preterm Birth (At delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ALFoNS - Growth and Metabolism in Infants Fed Protein-reduced, Alpha-lactalbumin Enriched Formula Compared to Breastfed Infants
Brief Summary: Formula composition is developed to resemble breast milk as close as possible, but there are still considerable differences between formula and breast milk composition, probably resulting in higher risk of overweight in childhood and higher incidence of infections in formula-fed infants. Protein levels are still higher and constituents such as alpha-lactalbumin lower in formula than in breast milk. By adding more alpha-lactalbumin to formula, rich in tryptophan, the resulting amino acid composition will allow further reduction of protein in formula. The investigators intend to include 320 infants, where 80 will be exclusively breastfed and the remainder assigned in a double blind, controlled, randomized manner to one of three formula groups; two experimental, protein reduced formula with two different levels of alpha-lactalbumin and one group given standard infant formula. The intervention period is from 4-8 weeks until 6 months of age. The infants will be followed by growth parameters, blood-, urine- and fecal biomarkers and health parameters until 5 years of age. The experimental formula will possibly result in growth, metabolism and gut microbiota as well as health parameters more similar to those of breastfed infants


Options:
A: frequency of metabolic acidosis
B: Practical handling,ease of use and safety information (number of participants with adverse events) (measurements were taken on day 0-5 and up to day 10 on preterms and through 2 days after the last infusion of study product)
C: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)
D: Growth (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Frequently Asked Questions as an Help to Improve the Information of ICU Patients' Families.
Brief Summary: The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of the stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The information comprehension at Day 5 (± 1) will be compared between families that received the list of "FAQ" and families that received information as usual (without providing the list of FAQ


Options:
A: Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool (6 month)
B: Child coping strategies (Change between baseline and 2 months post-baseline.); Child adjustment (Change between baseline and 2 months post-baseline.); Child adjustment (Change between baseline and 2 months post-baseline.); Parent adjustment (Change between baseline and 2 months post-baseline); Parent adjustment (Change between baseline and 2 months post-baseline.); Parent coping strategies (Change between baseline and 2 months post-baseline)
C: preferences for CPR (within one hour after oncology visit)
D: Evaluation of understanding at day 5 by a method of reformulation questionnaire (5th day after inclusion); Scale of satisfaction out of intensive care. (3 months and at one yearfter inclusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Carbetocin Versus Oxytocin in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial
Brief Summary: 200 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive ergometrine 0.5mg (methergin®, Novartis, Switzerland).


Options:
A: Maternal or Perinatal death or morbidity (within 42 days of pregnancy)
B: Hb of greater than or equal to 2 g/dl from pre- to post-delivery (3-5 days after delivery)
C: Proportion of women with post-delivery hemoglobin ≤ 7.8 gm/dL (72 hours (plus or minus 8 hours) after delivery)
D: Need for other uterotonics (2 minutes after giving the drug.)

Answer: D