TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Brief Summary: This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously \[IV\] once every 2 week \[q2w\]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray \[Gy\], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared \[mg/m\^2\] oral administration \[po\] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m\^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks \[q3w\]) or placebo monotherapy continued. The time on study treatment was until disease progression.


Options:
A: Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator (Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)); Co-Primary: Overall Survival (OS) (Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]))
B: Progression Free Survival (PFS) time (5 years)
C: Overall survival
D: Groups 1 and 2: Progression-free survival rate (6 months post-Day 1); Group 2C: Objective Response Rate (Every 8 weeks from Day 1 through progression or initiation of other anti-cancer therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Diabetes Risk Reduction Program With Overweight WIC Mothers
Brief Summary: 1) to evaluate treatment fidelity of DRRP: study design, training of interventionists, delivery and receipt of the intervention, and application of the intervention in real-life settings; 2) to identify successful strategies for participant recruitment and maintaining active participation; 3) to collect and analyze preliminary indicators of DRRP's effect on dietary intake, physical activity, stress responses, and body weight; and 4) To evaluate sample representativeness of the target audience, implementation and acceptability of DRRP, and attrition rate.


Options:
A: Body Mass Index (Baseline, 3-, 6- and 15- month follow-up)
B: Parameters of the metabolic syndrome (At baseline, and after 6 and 12 months)
C: body weight
D: Framingham Risk Score (15 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care
Brief Summary: The most effective transfusion practice in critically ill ICU patients is unknown. Currently the data is unclear as to whether a liberal or restrictive transfusion policy is of most benefit to patients in the short and longer term. The aim of this study is to test the hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (≥4 days).

Patients will be randomised to one of two transfusion strategies on a 1:1 basis

Group 1 "Restrictive RBC Transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.

Group 2 "Liberal RBC transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target of 91-110 g/L during intervention. These patients will all receive a transfusion on the day of randomisation.

Duration of Intervention:

Remainder of ICU stay or 14 days from randomisation, whichever is longer

Follow-Up

Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.

This is a feasibility study that will provide essential data to ensure the success of the full trial. A qualitative study will also be carried out to explore potential reasons for non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused group associated with transfusions.


Options:
A: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
B: Randomization Rate (12 months)
C: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
D: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care
Brief Summary: The most effective transfusion practice in critically ill ICU patients is unknown. Currently the data is unclear as to whether a liberal or restrictive transfusion policy is of most benefit to patients in the short and longer term. The aim of this study is to test the hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (≥4 days).

Patients will be randomised to one of two transfusion strategies on a 1:1 basis

Group 1 "Restrictive RBC Transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.

Group 2 "Liberal RBC transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target of 91-110 g/L during intervention. These patients will all receive a transfusion on the day of randomisation.

Duration of Intervention:

Remainder of ICU stay or 14 days from randomisation, whichever is longer

Follow-Up

Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.

This is a feasibility study that will provide essential data to ensure the success of the full trial. A qualitative study will also be carried out to explore potential reasons for non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused group associated with transfusions.


Options:
A: Death or Neurodevelopmental Impairment (Birth to 22-26 months corrected age); Death (Birth to 22-26 months corrected age); Neurodevelopmental Impairment (at 22-26 months corrected age); Cognitive Delay (at 22-26 months corrected age); Moderate or Severe Cerebral Palsy (at 22-26 months corrected age); Severe Vision Impairment (at 22-26 months corrected age); Severe Hearing Impairment (at 22-26 months corrected age)
B: 90-day mortality (after 90 days from study enrollment)
C: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
D: Postoperative Functional mobility; Restricting factors for functional mobility

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care
Brief Summary: The most effective transfusion practice in critically ill ICU patients is unknown. Currently the data is unclear as to whether a liberal or restrictive transfusion policy is of most benefit to patients in the short and longer term. The aim of this study is to test the hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (≥4 days).

Patients will be randomised to one of two transfusion strategies on a 1:1 basis

Group 1 "Restrictive RBC Transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.

Group 2 "Liberal RBC transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target of 91-110 g/L during intervention. These patients will all receive a transfusion on the day of randomisation.

Duration of Intervention:

Remainder of ICU stay or 14 days from randomisation, whichever is longer

Follow-Up

Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.

This is a feasibility study that will provide essential data to ensure the success of the full trial. A qualitative study will also be carried out to explore potential reasons for non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused group associated with transfusions.


Options:
A: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)
B: Cost-effectiveness ratio at 30 days (30 days)
C: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
D: Methodology of the pilot study (up to 30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care
Brief Summary: The most effective transfusion practice in critically ill ICU patients is unknown. Currently the data is unclear as to whether a liberal or restrictive transfusion policy is of most benefit to patients in the short and longer term. The aim of this study is to test the hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (≥4 days).

Patients will be randomised to one of two transfusion strategies on a 1:1 basis

Group 1 "Restrictive RBC Transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.

Group 2 "Liberal RBC transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target of 91-110 g/L during intervention. These patients will all receive a transfusion on the day of randomisation.

Duration of Intervention:

Remainder of ICU stay or 14 days from randomisation, whichever is longer

Follow-Up

Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.

This is a feasibility study that will provide essential data to ensure the success of the full trial. A qualitative study will also be carried out to explore potential reasons for non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused group associated with transfusions.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
C: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
D: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care
Brief Summary: The most effective transfusion practice in critically ill ICU patients is unknown. Currently the data is unclear as to whether a liberal or restrictive transfusion policy is of most benefit to patients in the short and longer term. The aim of this study is to test the hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (≥4 days).

Patients will be randomised to one of two transfusion strategies on a 1:1 basis

Group 1 "Restrictive RBC Transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.

Group 2 "Liberal RBC transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target of 91-110 g/L during intervention. These patients will all receive a transfusion on the day of randomisation.

Duration of Intervention:

Remainder of ICU stay or 14 days from randomisation, whichever is longer

Follow-Up

Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.

This is a feasibility study that will provide essential data to ensure the success of the full trial. A qualitative study will also be carried out to explore potential reasons for non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused group associated with transfusions.


Options:
A: Cost-effectiveness ratio at 30 days (30 days)
B: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
C: Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction (Within 30 days of randomization)
D: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care
Brief Summary: The most effective transfusion practice in critically ill ICU patients is unknown. Currently the data is unclear as to whether a liberal or restrictive transfusion policy is of most benefit to patients in the short and longer term. The aim of this study is to test the hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (≥4 days).

Patients will be randomised to one of two transfusion strategies on a 1:1 basis

Group 1 "Restrictive RBC Transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.

Group 2 "Liberal RBC transfusion group":

Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target of 91-110 g/L during intervention. These patients will all receive a transfusion on the day of randomisation.

Duration of Intervention:

Remainder of ICU stay or 14 days from randomisation, whichever is longer

Follow-Up

Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.

This is a feasibility study that will provide essential data to ensure the success of the full trial. A qualitative study will also be carried out to explore potential reasons for non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused group associated with transfusions.


Options:
A: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)
B: Timed Up and Go-test (TUG)in seconds. (30 days)
C: Postoperative Functional mobility; Restricting factors for functional mobility
D: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Controlled Trial in Rural Burkina Faso to Determine the Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS). Part of the iLiNS Study
Brief Summary: To assess zinc-related biochemical and functional responses among young Burkinabe children with a presumed high risk of zinc deficiency who receive micronutrient products containing different amounts of zinc, provided with or between meals.


Options:
A: Change in length and length-for-age Z-score (9 to 18 mo of age); Change in weight and weight-for-age Z-score (9 to 18 mo of age); Incidence of diarrhea and laboratory-confirmed malaria infection (9 to 18 mo of age); Change in plasma zinc concentration (9 to 18 mo of age); Change in body composition (9 to 18 mo of age)
B: To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children (20 months (Jan 2005 to Sep 2006)); - Reduction in visits to health care providers for treatment of illness (20 months (Jan 2005 to Sep 2006)); - Reduction in drug use; antibiotics and other drugs during diarrheal illnesses (20 months (Jan 2005 to Sep 2006)); - Increase in ORS use during diarrhea in the intervention communities. (20 months (Jan 2005 to Sep 2006))
C: Reduction in duration of diarrhoea; Reeudction in total stool volume
D: Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment; Assess the acceptability of zinc therapy during diarrhoea in young children.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Controlled Trial in Rural Burkina Faso to Determine the Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS). Part of the iLiNS Study
Brief Summary: To assess zinc-related biochemical and functional responses among young Burkinabe children with a presumed high risk of zinc deficiency who receive micronutrient products containing different amounts of zinc, provided with or between meals.


Options:
A: To evaluate innate and adaptive immune response.; Future occurrence of acute diarrhoea, ARI and impetigo.
B: Change in length and length-for-age Z-score (9 to 18 mo of age); Change in weight and weight-for-age Z-score (9 to 18 mo of age); Incidence of diarrhea and laboratory-confirmed malaria infection (9 to 18 mo of age); Change in plasma zinc concentration (9 to 18 mo of age); Change in body composition (9 to 18 mo of age)
C: Birth weight; 3-month infant mortality
D: Change in length and length-for-age Z-score (36 weeks); Change in weight and weight-for-age Z-score (36 weeks); Incidence of diarrhea (36 weeks); Change in hemoglobin concentration (32 weeks); Change in micronutrient status (32 weeks); Innate and adaptive immune defense (32 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Controlled Trial in Rural Burkina Faso to Determine the Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS). Part of the iLiNS Study
Brief Summary: To assess zinc-related biochemical and functional responses among young Burkinabe children with a presumed high risk of zinc deficiency who receive micronutrient products containing different amounts of zinc, provided with or between meals.


Options:
A: Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age (After 24 months of program implementation); Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months) (monthly from study inclusion at 6 months to 23 months of age and at study endline); Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm (Monthly from study inclusion at 6 months to 23 months of age); Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted) (monthly from study inclusion at 6 months to 23 months of age and at study endline)
B: weight-for-height in children 6 to 60 mo of age (8 months)
C: Change in length and length-for-age Z-score (9 to 18 mo of age); Change in weight and weight-for-age Z-score (9 to 18 mo of age); Incidence of diarrhea and laboratory-confirmed malaria infection (9 to 18 mo of age); Change in plasma zinc concentration (9 to 18 mo of age); Change in body composition (9 to 18 mo of age)
D: Incidence of severe stunting (Length-for-age Z score < -3) (1 year after enrolment); Incidence of serious and non-serious adverse events (1 year)

Answer: C