TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: INTELLANCE-2: ABT-414 Alone or ABT-414 Plus Temozolomide Versus Lomustine or Temozolomide for Recurrent Glioblastoma: A Randomized Phase 2 Study of the EORTC Brain Tumor Group
Brief Summary: This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.


Options:
A: Objective response, as determined by the independent review facility (IRF) (Complete response or partial response, determined on two consecutive assessments ≥4 weeks apart); Progression-free survival, as determined by the IRF (6 months)
B: Overall Survival (7 years)
C: Overall survival (From date of study entry until the date of death from any cause (up to 10 years))
D: Adult Study: Overall Survival (OS) (From the date of randomization up to the date of participant's death; participants who completed treatment were to be assessed every 12 weeks, up to 28 months.); Adult Study: Progression-Free Survival (PFS) (Measured every 8 weeks from date of randomization until the date of first objective progression or subject's death, whichever occurred first, up to 2 years); Pediatric Study: Percentage of Participants With Adverse Events From the First Visit Until 49 Days After the Last Dose of Study Drug (From participant's first visit until 49 days after the participant's last dose of study drug, up to 63 weeks); Pediatric Study: Maximum Observed Serum Concentration (Cmax) of ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Maximum Observed Plasma Concentration (Cmax) of Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8); Pediatric Study: Half-life (t1/2) Observed for ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Half-life (t1/2) Observed for Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8); Pediatric Study: Area Under the Concentration-time Curve (AUC) Observed for ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Area Under the Concentration-time-curve (AUC) Observed for Unconjugated Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: INTELLANCE-2: ABT-414 Alone or ABT-414 Plus Temozolomide Versus Lomustine or Temozolomide for Recurrent Glioblastoma: A Randomized Phase 2 Study of the EORTC Brain Tumor Group
Brief Summary: This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.


Options:
A: Progression-free Survival (from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken))
B: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
C: Adult Study: Overall Survival (OS) (From the date of randomization up to the date of participant's death; participants who completed treatment were to be assessed every 12 weeks, up to 28 months.); Adult Study: Progression-Free Survival (PFS) (Measured every 8 weeks from date of randomization until the date of first objective progression or subject's death, whichever occurred first, up to 2 years); Pediatric Study: Percentage of Participants With Adverse Events From the First Visit Until 49 Days After the Last Dose of Study Drug (From participant's first visit until 49 days after the participant's last dose of study drug, up to 63 weeks); Pediatric Study: Maximum Observed Serum Concentration (Cmax) of ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Maximum Observed Plasma Concentration (Cmax) of Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8); Pediatric Study: Half-life (t1/2) Observed for ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Half-life (t1/2) Observed for Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8); Pediatric Study: Area Under the Concentration-time Curve (AUC) Observed for ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Area Under the Concentration-time-curve (AUC) Observed for Unconjugated Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8)
D: Overall Survival (OS) Time (Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Application of Appropriate Technology for Obesity Prevention and Control in Seven Centers in China
Brief Summary: The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China. In each center, about 12-16 primary and secondary schools, with totally at least 10000 participants were randomly selected (Primary: Secondary=1:1). All of the selected schools were randomly allocated to either intervention or control group (Intervention: Control=1:1).The multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.


Options:
A: Executive function (One year)
B: BMD total body, femoral neck and lumbar spine (L2-L4) measured by Dual Energy X Ray Absorbtiometry (15 years)
C: Change in the prevalence of overweight and obesity (Baseline, Month 9)
D: Students' BMI change immediately after the intervention completion (at end of the 8-month intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Application of Appropriate Technology for Obesity Prevention and Control in Seven Centers in China
Brief Summary: The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China. In each center, about 12-16 primary and secondary schools, with totally at least 10000 participants were randomly selected (Primary: Secondary=1:1). All of the selected schools were randomly allocated to either intervention or control group (Intervention: Control=1:1).The multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.


Options:
A: Change in BMI Percentile (baseline and 12 months)
B: Change in the prevalence of overweight and obesity (Baseline, Month 9)
C: Event-related brain potentials (Change from baseline, 36-40 weeks); Task Performance (Change from baseline, 36-40 weeks); Academic Achievement (Change from baseline, 36-40 weeks)
D: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Application of Appropriate Technology for Obesity Prevention and Control in Seven Centers in China
Brief Summary: The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China. In each center, about 12-16 primary and secondary schools, with totally at least 10000 participants were randomly selected (Primary: Secondary=1:1). All of the selected schools were randomly allocated to either intervention or control group (Intervention: Control=1:1).The multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.


Options:
A: Change in Body Mass Index from to baseline to 1 and 2 years (0-1-2 years); Change in overweight and obesity status according to IOTF norms (up to 2 years); Change in BMI Z score from baseline to one and two years (up to 2 years)
B: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
C: Change in the prevalence of overweight and obesity (Baseline, Month 9)
D: BMI (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis
Brief Summary: The purpose is to investigate the effect of strength training on muscle strength, muscle mass and nutritional status in patients with liver cirrhosis to clarify possible metabolic and inflammatory changes during this intervention. In addition the investigator examine if the intervention is associated with fewer hospital readmission and an improved quality of life.


Options:
A: Increase in muscle mass (Basal and three months); Change in Effort tolerance (Basal and three months)
B: glutamine synthetase activity (three months)
C: HVPG change (4 months)
D: Maximal voluntary muscle strength in knee extensor will be measured by an isokinetic dynamometer and hand strength by hand dynamometer. (12-14 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Endothelial Dysfunction in Patients Undergoing Non-cardiac Surgery
Brief Summary: More than one in 100 otherwise healthy patients undergoing non-cardiac surgery will die within 30 days post-operatively, and of these patients 45% will die from vascular causes such as myocardial infarction. The pathogenesis of perioperative myocardial infarction is complex and to date not fully elucidated. The physiological stress response associated with the surgical procedure is believed to be central in the development of perioperative cardiovascular complications. Surgery initiates systemic inflammation, hypercoagulability and increases the production of catecholamines and cortisol. These drastic systemic changes lead to a state of myocardial oxygen supply-demand mismatch, which added to acute endothelial dysfunction and ruptures of vulnerable plaques, may result in myocardial injury.

The endothelium is a regulator of vascular homeostasis, vascular tone and structure and exerts anticoagulant, antiplatelet and fibrinolytic properties. Endothelial dysfunction is characterized by a decreased vascular bioavailability of nitric oxide probably due to an increased degradation of nitric oxide via its interaction with locally produced reactive oxygen species. No clinical studies have investigated whether peri- and postoperative endothelial dysfunction is associated with an increased risk of perioperative myocardial injury. Endothelial dysfunction may be a key element in the development of perioperative myocardial injury.

The aim of this observational clinical study is to closely examine the endothelial function and its dynamics in the early postoperative period.


Options:
A: The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) (Up to 4 years); The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) (Up to 4 years); The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety (Up to 4 years)
B: For our first objective (i.e., the incidence of major perioperative vascular events) our primary outcome is major vascular events (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke) (30 days post surgery.)
C: Change from baseline endothelial function (reactive hyperemia index) at 4 days postoperatively (baseline before operation, 4 hours postoperatively and daily assessments day 1-4 after surgery.)
D: Diagnostic accuracy of DES vs. CTCA in the prediction of the postoperative hard cardiac events in patients undergoing intermediate to high risk noncardiac surgeries (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Refining and Pilot Testing Social Networks for Encouraging Healthy Behaviors: The Social Pounds Off Digitally (Social POD) Study
Brief Summary: Smartphones have the capability to monitor health-related behaviors (exercise, diet, etc.) and provide social support which has the potential to play a powerful role in health promotion. The objective of this study is to refine and pilot test the Social POD app for personalized health monitoring and interaction founded on a combination of social networks, recommender systems, motivational research, and health behavior theory. The aim of our proposed project is to conduct a 3-month pilot RCT among overweight and obese adults (N=150) comparing a theory-based podcast (TBP) plus self-monitoring using a commercially-available calorie and weight tracking app (current most popular diet self-monitoring method) versus TBP plus self-monitoring and social support/incentive points for participating with the Social POD app (TBP+Social POD).


Options:
A: Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) (baseline, 3, 6, 9, and 12 months)
B: Mediterranean diet compliance (1 year)
C: Weight Loss (Change from baseline to 18-months.)
D: Weight loss (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomised Trial of Alternative Forms of Hydration in Cancer Patients in the Last Days of Life (Feasibility Study)
Brief Summary: It is unclear whether the use of fluids given by a "drip" is beneficial to cancer patients in the last days of life, and as a result many individuals do not receive such treatment (although they do receive fluids by mouth, and regular mouth care). The researchers want to undertake a large study ("main study") to determine the benefits of fluids given by a drip, but first need to undertake a small study ("feasibility study") to ensure that the main study can be done.

The feasibility study will be done in twelve units (hospitals, hospices) in England \& Wales; each unit will be allocated a treatment at random, and all patients in the unit will receive that treatment (if appropriate). Standard treatment A consists of drinking fluids (if possible), regular mouth care, and treatment of any symptoms; standard treatment B consists of drinking fluids (if possible) , regular mouth care, fluids by a drip, and treatment of any symptoms.

Patients will be assessed on a four hourly basis, and any uncontrolled symptoms will be recorded. The main symptom of interest is agitation ("delirium"), which has multiple causes, including dehydration and kidney failure. Uncontrolled symptoms will be appropriately treated, e.g. patients with pain will be given painkillers. Equally, problems relating to the fluids given by a drip will also be recorded. Involvement in the study will not interfere with the patient's general care, and there will be no additional blood or other tests.


Options:
A: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
B: Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). (Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge); Caregiver Preparedness (Discharge and 2 and 6 months post-discharge)
C: Reduction in the incidence of Post-Operative Delirium (%) (Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first))
D: Recruitment rate (Up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomised Trial of Alternative Forms of Hydration in Cancer Patients in the Last Days of Life (Feasibility Study)
Brief Summary: It is unclear whether the use of fluids given by a "drip" is beneficial to cancer patients in the last days of life, and as a result many individuals do not receive such treatment (although they do receive fluids by mouth, and regular mouth care). The researchers want to undertake a large study ("main study") to determine the benefits of fluids given by a drip, but first need to undertake a small study ("feasibility study") to ensure that the main study can be done.

The feasibility study will be done in twelve units (hospitals, hospices) in England \& Wales; each unit will be allocated a treatment at random, and all patients in the unit will receive that treatment (if appropriate). Standard treatment A consists of drinking fluids (if possible), regular mouth care, and treatment of any symptoms; standard treatment B consists of drinking fluids (if possible) , regular mouth care, fluids by a drip, and treatment of any symptoms.

Patients will be assessed on a four hourly basis, and any uncontrolled symptoms will be recorded. The main symptom of interest is agitation ("delirium"), which has multiple causes, including dehydration and kidney failure. Uncontrolled symptoms will be appropriately treated, e.g. patients with pain will be given painkillers. Equally, problems relating to the fluids given by a drip will also be recorded. Involvement in the study will not interfere with the patient's general care, and there will be no additional blood or other tests.


Options:
A: Recruitment rate (Up to 12 months)
B: Participant Reduced Symptom Burden (From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion))
C: Functional status:Barthel Index. (through study completion, an average of 3 months); Mini-Nutritional Assessment scores (MNA) (through study completion, an average of 3 months); Mini Mental State Examination scores (MMSE) (through study completion, an average of 3 months); Frailty rates and transition between frailty states (through study completion, an average of 3 months); Postoperative delirium incidence rate [Confusion Assessment Method (CAM)] (through study completion, an average of 3 months); Postoperative bowel dysmotility (through study completion, an average of 3 months)
D: Reduction in the incidence of Post-Operative Delirium (%) (Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Isotonic Solution Administration Logistical Testing: Pilot Study for the Isotonic Solutions and Major Adverse Renal Events Trial
Brief Summary: The administration of intravenous crystalloids is ubiquitous in the care of the critically ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. Recent studies of associated higher fluid chloride content with acute kidney injury and mortality but no large, randomized trials have been conducted. In preparation for a large, cluster-randomized, multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot study will enroll all patients admitted to the medical intensive care unit at a single tertiary center for a sixth month period. The primary objective will be to test the ability of an electronic order entry tool to ensure administration of assigned study fluid or record contraindications to assigned study fluid. The pilot study will also demonstrate the feasibility of collecting demographic, severity of illness, fluid management, vital sign, laboratory, acute kidney injury and renal replacement therapy, and outcome data in an automated, electronic fashion.


Options:
A: Proportion of Isotonic Crystalloid Which is 0.9% Saline (30 days)
B: Quality of Recovery-40 Score at 24 Hours (24 hours after ED visit)
C: Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism. (J1 and J2)
D: Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV) (Day 1 (4 Hours after start of IV))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles
Brief Summary: The aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.


Options:
A: Live Birth (1 year)
B: Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS). (2 minutes after biopsy procedure)
C: Clinical pregnancy rate (6 months)
D: Clinical pregnancy rate. (one year); Miscarriage rate. (one year); Multiple pregnancy rates (one year)

Answer: D