TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeted Chemo-elimination (TCE) to Eradicate Malaria in Areas of Suspected or Proven Artemisinin Resistance in Southeast Asia and South Asia
Brief Summary: The overall aim of this study is two fold:

1. to pilot targeted chemo-elimination of plasmodium falciparum malaria in known areas of artemisinin resistance in South East Asia.
2. to understand the micro-epidemiology of malaria in these areas; chiefly, the prevalence and importance to on-going transmission of sub-clinical p.f malaria infections.


Options:
A: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)
B: Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month) (For up to 12 months); P.falciparum infection incidence rate among individuals ≥3 months (For up to 12 months)
C: Cumulative notified malaria incidence in the MDA and control Shehias (6 months after second round of MDA)
D: prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 12 months after the first administration of treatment with dihydroartemisinin-piperaquine and primaquine. (1017-13 and 23-15) (12 months); prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 12 months after the first administration of targeted malaria elimination (1015-13) (12 months); prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 4 months after the first administration of target malaria-elimination (23-15) (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome
Brief Summary: The purpose of this study is to evaluate whether general anesthesia or sedation technique is preferable during embolectomy for stroke, measured in terms of three months neurological impairment. In addition we study if there is any difference between the methods regarding complication frequency.


Options:
A: The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 (Day 90)
B: Modified Angiographic collateral circulation assessed by blinded core lab (Immediately prior to revascularization)
C: Growth of DWI lesion (48-72 hours)
D: Neurological outcome in the two different arms (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: READI (Readiness Evaluation And Discharge Interventions): Implementation as a Standard Nursing Practice for Hospital Discharge
Brief Summary: Preparation of patients for discharge is a primary function of hospital-based nursing care and readiness for discharge is an important outcome of hospital care. Inadequacies in discharge preparation have been well-documented and linked to difficulty with self-management after hospital discharge and with increased likelihood of emergency department (ED) use and readmission. Prior studies by the research team have led to recommendations for implementation of discharge readiness assessment as a standard nursing practice for hospital discharge.

The investigators will conduct a multi-site study to determine the impact on post-discharge utilization (readmission and ED visits) and costs of implementing discharge readiness assessment as a standard nursing practice for adult medical-surgical patients discharged to home. The study tests, in a stepped approach, the impact of implementing discharge readiness assessment by the discharging nurse as standard nursing practice (RN-RHDS protocol), the incremental value of informing the nurse assessment with the patient's perspective (RN-RHDS+PT-RHDS protocol), and of requiring that the nurse initiates and documents risk-mitigating actions for patients with low readiness scores (RN-RHDS+PT-RHDS+NIAF protocol).

HYPOTHESIS 1: Patients discharged using the RN-RHDS protocol will have fewer hospital readmissions and ED visits within 30 days post-discharge compared to patients discharged under usual care conditions.

HYPOTHESIS 2: Patients discharged using the RN-RHDS+PT-RHDS protocol will have fewer hospital readmissions and ED visits within 30 days post-discharge compared to patients discharged using the RN-RHDS protocol.

HYPOTHESIS 3: Patients discharged by nurses using the RN-RHDS+PT-RHDS protocol plus a Nurse-Initiated Action Form \[NIAF\] (RN-RHDS+PT-RHDS+NIAF protocol) will have fewer post-discharge readmissions and ED visits than patients discharged using the RN-RHDS+PT-RHDS protocol; the effect will be strongest for patients with low RHDS scores.

Aim 4: Conduct cost-benefit analysis of implementing discharge readiness assessment as standard practice, by comparing cost-savings from reduced post-discharge utilization against implementation costs.


Options:
A: Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months (Measured at baseline, 6, 12 and 18 months after randomisation)
B: Risky drinking (6, 12, 18, 24 months)
C: Change in Depressive symptoms (3, 6 and 12 months.)
D: Post-discharge Utilization within 30 days after hospital discharge (30 days after hospital discharge)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial
Brief Summary: The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiolitis in infants in improving respiratory distress and comfort and reducing length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).


Options:
A: Respiratory Assessment Change Score (RACS) (Baseline and 1 hour)
B: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered (Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h))
C: length of hospital stay (2 years)
D: Time to 'fit for discharge' (This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial
Brief Summary: The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiolitis in infants in improving respiratory distress and comfort and reducing length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).


Options:
A: Treatment failure (24 months)
B: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered (Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h))
C: Number of participants with HFNC success (during hospitalization, approximatly 6 days); Number of participants with CPAP/NPPV success (during hospitalization, approximatly 6 days)
D: Mean esophageal pressure (3.5 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial
Brief Summary: The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiolitis in infants in improving respiratory distress and comfort and reducing length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).


Options:
A: Time to 'fit for discharge' (This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.)
B: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered (Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h))
C: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)
D: Change in Bronchiolitis Severity Score (Baseline and up to 24 hours of hospital stay)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
Brief Summary: The hypothesis is that there is a profit potential by implementing a multifactorial nutritional intervention among frail elderly since this will result in an improved nutritional status, functional capacity and improved quality of life.


Options:
A: fall-related injury (Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).)
B: Quality of life (up to 6 months)
C: Proportion of residents receiving at least one antipsychotic medication after 12 months (12 months)
D: Change in falls rate (3 months from baseline measures, 6 months from baseline, 9 months from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW) administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.


Options:
A: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
B: Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period (Day 1 to Month 4); Injection-Related Adverse Event Rate Per Year in the Extension Period (Month 5 up to Month 10); Injection-Related Adverse Events in the Extension Period (Month 5 up to Month 10)
C: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)
D: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
Brief Summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.


Options:
A: Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria (The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.)
B: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018)
C: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
D: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
Brief Summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.


Options:
A: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator (Up to ~38 months)
B: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)
C: Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) (At 28 days); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) (At 28 Days); Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) (Time from start of treatment to time of objective disease progression, assessed up to 5 years); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). (At 28 days)
D: PFS Rate at 36 Weeks (After 9 Months) (36 weeks (after 9 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
Brief Summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.


Options:
A: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)
B: To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up)); To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up).)
C: Progression-free Survival (Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month))
D: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
Brief Summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.


Options:
A: Progression Free Survival (2 years)
B: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)
C: Progression-free survival
D: ORR (Up to 2 years); PFS (Up to 2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
Brief Summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.


Options:
A: MDS/AML reports related to PARPi (from WHO database). (From inception to May 3, 2020); MDS/AML reports related to PARPi (from French database). (From inception to May 1, 2021)
B: Progression Free Survival (Up to 34 months)
C: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)
D: Progression free survival (30 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
Brief Summary: To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.


Options:
A: Ratio of UACR at Day 90 to UACR at Baseline (Baseline and Day 90±2)
B: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date (Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)); Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) (Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011))
C: Change of of Systolic Blood Pressure (4 months); Change of Diastolic Blood Pressure (4 months)
D: Change of serum potassium (4 weeks)

Answer: A