TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-exercise Activity Thermogenesis (NEAT) - Prevention and Treatment of Overweight and Obesity
Brief Summary: This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when implementing active workstation at offices compared to conventional office work. The primary hypothesis is that this implementation will lead to a significant increase in time spent walking per day.


Options:
A: Mean Change in Light-intensity Physical Activity at Work From Baseline to 12 Months (1 year); Mean Change in Sitting Time at Work From Baseline to 12 Months (1 year)
B: Incidence of CHD and other lifestyle related diseases after ten years (2012)
C: Change in sedentary behavior during the workday (Baseline - week 8)
D: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-exercise Activity Thermogenesis (NEAT) - Prevention and Treatment of Overweight and Obesity
Brief Summary: This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when implementing active workstation at offices compared to conventional office work. The primary hypothesis is that this implementation will lead to a significant increase in time spent walking per day.


Options:
A: Physical Activity (Measured 5 times over 13 months, for seven days each time. Time points = baseline, 1-2weeks, 3 months, 6 months and 12 months)
B: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
C: Change from control week and intervention week in total energy expenditure (TEE) (week 1 and week 2); Resting energy expenditure (REE) (Baseline (day 0)); Change from control week and intervention week in physical activity energy expenditure (PAEE) (week 1 and week 2); Change from control week and intervention week in daily time spent in sedentary (SB) (week 1 and week 2); Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities (week 1 and week 2); Change from control week and intervention week in number of breaks in sedentary time (BST) (week 1 and week 2); Change from control week and intervention week in time spent sitting (TSS) (week 1 and week 2); Change from control week and intervention week in time spent standing (TSst) (week 1 and week 2); Change from control week and intervention week in time spent walking (TSW) (week 1 and week 2); Change from control week and intervention week in number of steps (week 1 and week 2)
D: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-exercise Activity Thermogenesis (NEAT) - Prevention and Treatment of Overweight and Obesity
Brief Summary: This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when implementing active workstation at offices compared to conventional office work. The primary hypothesis is that this implementation will lead to a significant increase in time spent walking per day.


Options:
A: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)
B: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)
C: Daily sitting time (baseline and 23 weeks)
D: Average steps per day (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-exercise Activity Thermogenesis (NEAT) - Prevention and Treatment of Overweight and Obesity
Brief Summary: This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when implementing active workstation at offices compared to conventional office work. The primary hypothesis is that this implementation will lead to a significant increase in time spent walking per day.


Options:
A: Low Back Pain Disability (6 months); Usual Low Back Pain (6 months)
B: Change in Occupational Physical Activity From Baseline to 16 Weeks (Baseline and 16 weeks)
C: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))
D: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Written Information and Support Phone Calls for First Time Mothers on Breastfeeding Rates: A Randomized Controlled Trial
Brief Summary: In Croatia, between 95% and 99% of mothers initiate breastfeeding, but by 3 months a third have stopped, and by six months only half are still providing any human milk for their babies. Exclusive breastfeeding rates are even lower, with only about 9% of Croatian mothers exclusively breastfeeding at 6 months, despite the WHO recommendation of 6 months of exclusive breastfeeding. Currently, in Croatia, no breastfeeding information or other pregnancy and parenting related written information is routinely provided to expectant couples. In our study we would like to find out whether providing written breastfeeding information in pregnancy and breastfeeding focused support phone calls during pregnancy and after the birth of the baby result in better outcomes than providing general pregnancy/parenting information and support phone calls. This will be tested by randomising women, attending their primary health care provider for routine antenatal visits between 20 and 32 weeks, to an intervention focused on promoting and supporting breastfeeding, to an intervention focused on general pregnancy and parenting issues, and to a non-intervention control group. Women will be followed-up for 6 months after the birth of their baby and data will be collected at 3 and 6 months on breastfeeding rates, breastfeeding self-efficacy, breastfeeding difficulties, social support and attitudes toward infant feeding.


Options:
A: Percent of infants breastfed exclusively (4 weeks of age); Daily volume of formula supplement received by mixed feeders (at 4 weeks of age)
B: Gastrointestinal tract infection (12 months of age)
C: Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention (through study completion, an average of 6 months)
D: Exclusive breastfeeding (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. A Systematic Review and Meta-analysis of Randomized Controlled Trials Comparing These Drugs Either vs Insulin or vs Each Other.
Brief Summary: Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (GDM), additional studies of oral agents for the treatment of GDM have been published (observational, randomized controlled trials (RCT), and trials using other drugs like metformin).

Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including 4 RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different drugs, the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT addressing metformin vs insulin).

Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize this evidence using meta-analysis tools. Specifically, investigators aim at producing distinct meta-analyses for each one of the three drug comparisons. This information is not available in the literature since the most recent systematic reviews specifically dealing on oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)


Options:
A: Mean Fetal Weight at Birth (Immediately after delivery of fetus)
B: 3rd trimester glycated hemoglobin (3rd trimester of pregnancy); total maternal weight gain (during pregnancy); severe maternal hypoglycemia (from enrollment to delivery); preeclampsia (during pregnancy or puerperium); cesarean section (at the end of pregnancy); gestational age at birth (at birth); preterm birth (at birth); birthweight (at birth); macrosomia (at birth); large-for-gestational age newborn (at birth); small-for-gestational age newborn (at birth); neonatal hypoglycemia (in the neonatal period); perinatal mortality (in the perinatal period); insulin treatment (from enrollment to delivery)
C: Need of insulin treatment for GDM (Day of delivery)
D: Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1) (Month 3 through extension Month 60); Change From Baseline in FEV1 (Baseline through extension follow up Month 3); Annual Rate of Change in FEV1 (Week -2 through extension follow up Month 3 or end of study); Summary of ≥ 15 % Decliners in FEV1 (Month 3 through extension follow up Month 3); Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) (Week -2 through extension follow up Month 3 or end of study); Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) (Baseline through extension follow up Month 3); Summary of ≥ 20 % Decliners in DLco (Month 3 through extension follow up Month 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. A Systematic Review and Meta-analysis of Randomized Controlled Trials Comparing These Drugs Either vs Insulin or vs Each Other.
Brief Summary: Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (GDM), additional studies of oral agents for the treatment of GDM have been published (observational, randomized controlled trials (RCT), and trials using other drugs like metformin).

Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including 4 RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different drugs, the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT addressing metformin vs insulin).

Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize this evidence using meta-analysis tools. Specifically, investigators aim at producing distinct meta-analyses for each one of the three drug comparisons. This information is not available in the literature since the most recent systematic reviews specifically dealing on oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)


Options:
A: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
B: Number of Participants Assessed for Glucose Control (fasting and 2 hour postprandial blood glucose)
C: Mean Fetal Weight at Birth (Immediately after delivery of fetus)
D: 3rd trimester glycated hemoglobin (3rd trimester of pregnancy); total maternal weight gain (during pregnancy); severe maternal hypoglycemia (from enrollment to delivery); preeclampsia (during pregnancy or puerperium); cesarean section (at the end of pregnancy); gestational age at birth (at birth); preterm birth (at birth); birthweight (at birth); macrosomia (at birth); large-for-gestational age newborn (at birth); small-for-gestational age newborn (at birth); neonatal hypoglycemia (in the neonatal period); perinatal mortality (in the perinatal period); insulin treatment (from enrollment to delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. A Systematic Review and Meta-analysis of Randomized Controlled Trials Comparing These Drugs Either vs Insulin or vs Each Other.
Brief Summary: Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (GDM), additional studies of oral agents for the treatment of GDM have been published (observational, randomized controlled trials (RCT), and trials using other drugs like metformin).

Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including 4 RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different drugs, the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT addressing metformin vs insulin).

Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize this evidence using meta-analysis tools. Specifically, investigators aim at producing distinct meta-analyses for each one of the three drug comparisons. This information is not available in the literature since the most recent systematic reviews specifically dealing on oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)


Options:
A: Birth Weight Per Arm (delivery)
B: 3rd trimester glycated hemoglobin (3rd trimester of pregnancy); total maternal weight gain (during pregnancy); severe maternal hypoglycemia (from enrollment to delivery); preeclampsia (during pregnancy or puerperium); cesarean section (at the end of pregnancy); gestational age at birth (at birth); preterm birth (at birth); birthweight (at birth); macrosomia (at birth); large-for-gestational age newborn (at birth); small-for-gestational age newborn (at birth); neonatal hypoglycemia (in the neonatal period); perinatal mortality (in the perinatal period); insulin treatment (from enrollment to delivery)
C: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
D: Alive baby (At birth, up to 28 days after birth); Neonatal morbidity (at birth upto 28 days after birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. A Systematic Review and Meta-analysis of Randomized Controlled Trials Comparing These Drugs Either vs Insulin or vs Each Other.
Brief Summary: Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (GDM), additional studies of oral agents for the treatment of GDM have been published (observational, randomized controlled trials (RCT), and trials using other drugs like metformin).

Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including 4 RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different drugs, the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT addressing metformin vs insulin).

Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize this evidence using meta-analysis tools. Specifically, investigators aim at producing distinct meta-analyses for each one of the three drug comparisons. This information is not available in the literature since the most recent systematic reviews specifically dealing on oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)


Options:
A: Glucose area-under-the-curve (During 3 days of each diet treatment)
B: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
C: Need of insulin treatment for GDM (Day of delivery)
D: 3rd trimester glycated hemoglobin (3rd trimester of pregnancy); total maternal weight gain (during pregnancy); severe maternal hypoglycemia (from enrollment to delivery); preeclampsia (during pregnancy or puerperium); cesarean section (at the end of pregnancy); gestational age at birth (at birth); preterm birth (at birth); birthweight (at birth); macrosomia (at birth); large-for-gestational age newborn (at birth); small-for-gestational age newborn (at birth); neonatal hypoglycemia (in the neonatal period); perinatal mortality (in the perinatal period); insulin treatment (from enrollment to delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Individualized NUTritional Counselling on Muscle Mass and Treatment Outcome in Patients With Metastatic COLOrectal Cancer Undergoing Chemotherapy: the COLONUT Study
Brief Summary: The purpose is to study the effect of individualized nutritional counselling compared to usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal cancer during first line chemotherapy. Secondary, effect on total lean body mass, treatment intensity, physical functioning, quality of life and survival will be studied.We hypothesize that patients in the intervention arm benefit from individualized nutritional counseling.


Options:
A: Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care (During 9 weeks of first line chemotherapy)
B: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) (6 months)
C: Breast Cancer Recurrence (Lifetime)
D: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) (baseline, 3, 6, and 12 months); Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
Brief Summary: The main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with COPD that have recently completed a pulmonary rehabilitation program.


Options:
A: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)
B: Feasibility of tai chi intervention (24 weeks)
C: Changes in objectively measured physical activity (2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4))
D: Change From Baseline in Endurance Time (Seconds) (Week 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
Brief Summary: The main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with COPD that have recently completed a pulmonary rehabilitation program.


Options:
A: Treatment Adherence (10 months)
B: Feasibility of tai chi intervention (24 weeks)
C: Exercise behavior (3 & 6 Months)
D: Steps per day as mean over one week from baseline until the treatment end (Every day for 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Doubly-Randomized, Placebo-Controlled Study of Intranasal Esketamine in an Adaptive Treatment Protocol to Assess Safety and Efficacy in Treatment-Resistant Depression (SYNAPSE)
Brief Summary: The purpose of this study is to assess the efficacy and dose response of intranasal esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with placebo in improving depressive symptoms in participants with treatment-resistant depression (TRD).


Options:
A: Measurements of BOLD signal in the brain area BA25 (Day1 (at infusion))
B: The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score. (Change from Baseline)
C: Panel A and B: Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Day 8- Analysis of Covariance (ANCOVA) Analysis (Baseline (Day 1) and Endpoint (Day 8) of Period 1); Panel A and B: Change From Baseline (Day 8) in Montgomery Asberg Depression Rating Scale Total Score at Day 15- ANCOVA Analysis (Baseline (Day 8) and Endpoint (Day 15) of Period 2)
D: Change in Scale for Suicidal Ideation (Day 1 (24 hours) post-treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin
Brief Summary: This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.


Options:
A: HbA1c Change From Baseline to Week 24 (Baseline and week 24)
B: HbA1c (after 26 weeks of treatment)
C: Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach (Baseline and Week 52); Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106 (Up to Week 106); Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104 (Up to Week 104)
D: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)

Answer: C