TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Effectiveness of Intermittent Preventive Treatment Delivered Through the Expanded Programme of Immunisation for Malaria and Anaemia Control in Tanzanian Infants
Brief Summary: The safety and efficacy of Intermittent Preventive Treatment for malaria and anaemia control in Infants (IPTi) have already been documented in Southern Tanzania, affording an opportunity to gain operational experience in developing a strategy for the longer-term implementation of IPTi. Working in conjunction with national and district-based health authorities, a strategy will be developed to make IPTi available through routine health services and an effectiveness evaluation conducted. This will be based on the comparison of process and outcome indicators in areas with and without IPTi. Information on safety will be consolidated and the effect of IPTi on the rate of development of drug resistance explored. The acceptability and costs of implementing IPTi will be monitored and combined with assessments of effectiveness (in terms of morbidity and mortality) to assess the cost-effectiveness of IPTi.


Options:
A: Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period). (During the surveillance period (September to December 2008))
B: Incidence of clinical malaria (2008-2009)
C: N/A
D: Mortality rate in children aged 2-11 months (estimated by birth history questioning) (Up to 12 months of age); Incidence of severe adverse drug reactions following IPTi (as detected by spontaneous, passive reporting system) (All age groups, particular attention in under 2 year olds)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
Brief Summary: This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by treatment with TS-1 within 45 days after curative resection (curability A or B). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.


Options:
A: Overall survival (every course for first three courses, then every other course)
B: Number of Participants Experiencing Adverse Events (AEs) (Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Number of Participants Discontinuing From Study Treatment Due to an AE (Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) (Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)); Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 (Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016)
C: Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC. (3 years)
D: Time to Progression (every 8 weeks up to a maximum of 36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
Brief Summary: This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by treatment with TS-1 within 45 days after curative resection (curability A or B). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.


Options:
A: Overall survival (every course for first three courses, then every other course)
B: Progression free survival (PFS), as measured by RECIST per local review (Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.)
C: Progression-free Survival (Treatment will continue until disease progression or intolerable toxicity, up to 2 years)
D: Overall Survival (From randomization until death, up to 26 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety (Including Bone Density Assessment) of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata
Brief Summary: The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.


Options:
A: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) (3 months); Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist (Week 13 visit); Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist (Up to week 17)
B: The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention. (Month 12 or Final Visit)
C: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses (18 months study duration per subject (4 3-month intermittent treatment courses))
D: Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index. (Final visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)
Brief Summary: An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines)


Options:
A: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
B: Cervical spine radiography ordering proportions (12 months)
C: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)
D: colorectal cancer screening (15 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)
Brief Summary: An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines)


Options:
A: Bone mineral density (BMD) testing rates
B: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)
C: The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture
D: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)
Brief Summary: An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines)


Options:
A: Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients (14 days)
B: Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.
C: Hospital rate of permanent colostomy; Hospital rate of local recurrence
D: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)
Brief Summary: An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines)


Options:
A: Episiotomies; Oxytocin use in third stage of labor
B: glycemic control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians); lipid control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians)
C: The primary outcome measure will be the "improvement" of prescribing for efficacious therapies in patients with a chronic cardiovascular disease within six months of the intervention.
D: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)
Brief Summary: An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines)


Options:
A: Fall risk management, assessment and management of gate, strength and balance deficits, completion of medication review, including postural hypotension and psychotropic medications as well as the assessment and management of environmental risk factors.
B: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.
C: Bone mineral density (BMD) testing rates
D: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multicentre, Double Blind, Placebo-controlled, Parallel Group 52-week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate
Brief Summary: Patients will be assigned to one of three treatment groups. Study medication is administered over a 52 week study duration.


Options:
A: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
B: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years (From first dose of CZP to the end of the open-label study (approximately 6.8 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years (From first dose of CZP to the end of the open-label study (approximately 6.8 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.3 years))
C: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
D: To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multicentre, Double Blind, Placebo-controlled, Parallel Group 52-week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate
Brief Summary: Patients will be assigned to one of three treatment groups. Study medication is administered over a 52 week study duration.


Options:
A: Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate (At 12 Weeks)
B: Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26 (Week 26)
C: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)
D: To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870
Brief Summary: A 26 week maintenance study of CDP870 in Crohn's disease


Options:
A: Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase (Baseline to Week 6)
B: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months) (Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months) (Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374))
C: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
D: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments (Baseline, Week 10); Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments (Baseline, Week 10)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870
Brief Summary: A 26 week maintenance study of CDP870 in Crohn's disease


Options:
A: Number of Participants in Population 1 With a Clinical Response at Week 8 (Week 8)
B: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
C: Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24 (Week 24); The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24 (Week 24); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52 (Week 52); The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52 (Week 52)
D: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870
Brief Summary: A 26 week maintenance study of CDP870 in Crohn's disease


Options:
A: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
B: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8.
C: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
D: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870
Brief Summary: A 26 week maintenance study of CDP870 in Crohn's disease


Options:
A: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
B: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
C: Number of Participants With Clinical Response at Week 6 (Baseline to Week 6)
D: Number of Participants With Clinical Response at Week 6 (Baseline and Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease
Brief Summary: A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease


Options:
A: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26
B: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
C: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months) (Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months) (Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374))
D: The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth (Day 0)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease
Brief Summary: A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease


Options:
A: Number of Participants With Clinical Response at Week 6 (Baseline and Week 6)
B: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26
C: Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24 (Week 24); The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24 (Week 24); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52 (Week 52); The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52 (Week 52)
D: Number of Participants With Clinical Response at Week 6 (Baseline to Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease
Brief Summary: A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease


Options:
A: Percentage of patients with ACR 20 response (Week 24)
B: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)
C: American College of Rheumatology (ACR) 20 Response at Week 14. (Week 14)
D: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease
Brief Summary: A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease


Options:
A: Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF) (8 weeks)
B: Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment (Baseline to 8 weeks)
C: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26
D: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)

Answer: C