TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Perioperative Systemic Lidocaine on Quality of Recovery After Outpatient Gynecologic Laparoscopy
Brief Summary: Although ambulatory gynecological laparoscopy is considered to be a minimally invasive surgical procedure, only 60% of patients undergoing this procedure are satisfied with postoperative pain control. Postoperative pain can lead to physiological, immunological and psychological derangements in patients.It also has been shown to be the most common cause of hospital admission after outpatient surgery.

Opioids constitute the most commonly used pain management strategy after surgery, however they have many undesirable side effects including nausea, vomiting and respiratory depression. Different strategies have been developed to decrease the amount of opioid required after surgery. Opioid sparing drugs as well as regional anesthesia have been shown to be effective. Systemic administration of lidocaine has been shown to decrease opioid consumption, improve recovery of bowel function and promote a better recovery after inpatient procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and anti-inflammatory properties. It also has an excellent safety profile when give by a low-dose infusion.

The improvement of surgical technique and anesthesia care has made major adverse outcomes infrequent, especially in the ambulatory setting. Assessing patient's quality of recovery has become an important outcome in several studies. The patient's capacity to return to his normal activities is one of the most important sign of a successful outpatient procedure and it has significant economic implications.

Quality of recovery -40(QoR-40) is a validated 40 item instrument to assess the quality of post-operative recovery. Myels et al. have concluded that the QoR-40 would be a useful outcome measure to assess the impact on changes in health care delivery, but anesthesia studies underutilize this instrument.

The research question for the study is; does the use of systemic perioperative lidocaine improve quality of recovery after outpatient laparoscopy?


Options:
A: Quality of Recovery 40 Score (24 hours post surgery)
B: Postoperative pain measured using Visual analogue scale at postoperative 2hour (post op 2hour)
C: The primary endpoint of this study was the QoR 40 (24 hours after the operation)
D: Postopeartive pain measured using Visual analogue scale at postoperative 4hour (post op 4hour)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Glutamine is the most abundant nonessential amino acid in the human body. Besides its role as a constituent of proteins and its importance in amino acid transamination, glutamine may modulate immune cells.

The innate immune system is the first line of host defence against pathogens and in most cases sufficient to eliminate invading microbes. Mammalian Toll-like receptors (TLR) comprise a family of germ line-encoded trans-membrane receptors which activation leads to the induction of inflammatory responses, phagocytosis but also to the development of antigen specific adapative immunity.

It has been postulated though not formally proven yet that glutamine beneficial effect could be due to a positive effect on the innate immune system. Given the importance of TLRs and TLRs-dependent signalling in host defence against infections we hypothesized that glutamine may increase the expression and/or functionality of TLRs which in turn may have beneficial effects to clear infections.


Options:
A: Time to Discharge Alive (3 months)
B: 28-day Mortality (Day 28)
C: -Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry
D: The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days. (daily until discharge from intensive care unit, death or maximum duration of 10 days.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment
Brief Summary: This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.


Options:
A: Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) (Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years); Second-Line PFS (Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years); Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6 (Month 6); Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12 (Month 12); Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18 (Month 18); Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24 (Month 24)
B: Pathologic complete response
C: Determination of pCR rates (2010)
D: Overall Survival (From date of randomization until death from any cause)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL)
Brief Summary: The choice of a preferred first-line treatment requires balancing the desire for optimal disease control with the occurrence of early and late treatment-related effects. To fully assess this balance, the treatment decision process should ideally take into account the outcome following a consistent second-line therapy, in particular when tolerated, widely applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing initial chemotherapy.


Options:
A: N/A
B: Failure-free Survival at 5 Years (Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5)
C: Freedom from first progression at 5 years (After a median of 5 years from start of the study)
D: Overall survival; Reduction of late treatment-related toxicity; Maintenance of failure-free survival rate

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL)
Brief Summary: The choice of a preferred first-line treatment requires balancing the desire for optimal disease control with the occurrence of early and late treatment-related effects. To fully assess this balance, the treatment decision process should ideally take into account the outcome following a consistent second-line therapy, in particular when tolerated, widely applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing initial chemotherapy.


Options:
A: Freedom from first progression at 5 years (After a median of 5 years from start of the study)
B: Progression Free Survival (5 years)
C: N/A
D: 3-year progression-free survival (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Asthma Outcomes Through Cultural Competence Training for Physicians
Brief Summary: The proposed randomized clinical trial will compare two educational interventions: Physicians Asthma Care Education (PACE) and PACE Plus with 90 physicians in Atlanta and the Bronx and their 1192 patients.


Options:
A: ER visits (18 months)
B: Emergency department visits - 1st time point (12months prior to baseline interview); Emergency Department Visits -2nd time point (Interval between baseline interview and 12 month interview); Emergency Department Visits - 3rd time point (Interval between 12 month and 24 month telephone interview)
C: Emergency Department Visits - 1st time point (12 months prior to baseline interview); Emergency Department Visits - 2nd time point (Interval between baseline and 9 months); Emergency Department Visits - 3rd time point (interval between 9 month and 18 month telephone interview)
D: medication adherence (on year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding
Brief Summary: This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.

This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.


Options:
A: Shrinkage of Fibroids - Size of Fibroids (3 months (baseline to end of treatment))
B: Myoma size (2004 to 2007)
C: Efficacy endpoints (From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.); Number and proportion of subjects experiencing open label treatment-emergent adverse events (From baseline to end of PGL4001 treatment (3months treatment))
D: percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received (From baseline to end of each PGL4001 treatment (3months treatment))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding
Brief Summary: This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.

This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.


Options:
A: percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received (From baseline to end of each PGL4001 treatment (3months treatment))
B: Uterine Volume (6 months)
C: The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention. (Month 12 or Final Visit)
D: 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))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 (cαStx1) and 2 (cαStx2) Administered Concomitantly to Children With Shiga Toxin-Producing Bacterial (STPB) Infection and Bloody Diarrhea (SHIGATEC Trial)
Brief Summary: This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB) Infection.


Options:
A: Time to death or serious extrarenal events (60 days); Time to dialysis (60 days)
B: Safety and Tolerability: Evaluation of number and type of adverse events and serious adverse events between arms and dosage cohorts (Up to 1 year)
C: Number of children enrolled in the study protocol (at the end of the 24 month study recruiting period)
D: the duration in days of extrarenal epuration (From the inclusion date and assessed up to 13 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Children's Intake of Foods Reduced in Energy Density
Brief Summary: The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined.


Options:
A: Food intake (1 month)
B: Differences in Food and Beverage Intake by Energy (Days 1-5 in Periods 1 and 2)
C: Change in vegetable intake (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)); Change in vegetable liking (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)); Child self-regulation of energy intake (Measured at child age of 18 months); Change in child self-regulation of energy intake (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up))
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Children's Intake of Foods Reduced in Energy Density
Brief Summary: The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined.


Options:
A: Intake of vegetables and fruit (One month)
B: Food intake (1 month)
C: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
D: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Children's Intake of Foods Reduced in Energy Density
Brief Summary: The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined.


Options:
A: Mean Nutrition Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)); Mean Physical Activity Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up))
B: Change in Child Physical Activity (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.); Change in Child Dietary Intake (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
C: Food intake (1 month)
D: sugar-sweetened beverages (one time point (baseline only))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Children's Intake of Foods Reduced in Energy Density
Brief Summary: The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined.


Options:
A: Growth trajectories (using BMI, waist circumference), body composition (3 months)
B: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
C: Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks (Baseline, 6 weeks, 22 weeks, 28 weeks)
D: Food intake (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Children's Intake of Foods Reduced in Energy Density
Brief Summary: The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined.


Options:
A: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)
B: Fruit and Vegetable Consumption, servings per week (3 weeks); Perceived Behavioral Control scale score (3 weeks); Attitudes scale score (3 weeks); Intrinsic Motivation scale score (3 weeks); Fruit and vegetable consumption, servings per week (5 weeks); Perceived Behavioral Control scale score (5 weeks); Attitudes scale score (5 weeks); Intrinsic Motivation scale score (5 weeks)
C: Food intake (1 month)
D: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Children With ADHD Symptoms: Comorbid Conditions, Cognitive and Social Performance
Brief Summary: This article reviews social-demographic variables (SDV) including interpersonal and academic and social performance in families and comorbid conditions(CC) which are the most associated with Attention-Deficit/Hyperactivity Disorder (ADHD)in the sample that has been confirmed diagnosis of ADHD and sample with the same symptoms but not confirmed diagnosis of ADHD.

There are no reports of this kind in the Norwegian population with ADHD.


Options:
A: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks (Baseline and up to 7 weeks)
B: ADHD Severity (baseline and 20 weeks); Substance Use (20 weeks)
C: Clinicians Manuals from Russell A. Barkley as Disruptive Behavior Disorders Rating Scale--Parent Form (Form 4), Disruptive Behavior Disorders Rating Scale--Teacher Form (Form 5) and Clinical Interview--Parent Report Form (Form 6) (1 year)
D: Comparison Following Treatment Between Drug and Placebo Using Evaluation by SKAMP Combined, Attention, and Deportment Scales (Average over all post-dose time points (1.0, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5, and 12 hours))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Children With ADHD Symptoms: Comorbid Conditions, Cognitive and Social Performance
Brief Summary: This article reviews social-demographic variables (SDV) including interpersonal and academic and social performance in families and comorbid conditions(CC) which are the most associated with Attention-Deficit/Hyperactivity Disorder (ADHD)in the sample that has been confirmed diagnosis of ADHD and sample with the same symptoms but not confirmed diagnosis of ADHD.

There are no reports of this kind in the Norwegian population with ADHD.


Options:
A: Clinicians Manuals from Russell A. Barkley as Disruptive Behavior Disorders Rating Scale--Parent Form (Form 4), Disruptive Behavior Disorders Rating Scale--Teacher Form (Form 5) and Clinical Interview--Parent Report Form (Form 6) (1 year)
B: N/A
C: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
D: CGI -S - ADHD rating scale (Father) (Change from Screening at 8 weeks.); Conners Adult ADHD Rating Scale - Self Report (Father) (Change from Screening at 8 weeks.); Conners Other Report (about Father) (Change from Screening at 8 weeks); Barkley Functional Impairment Rating Scale (Father) (Change from Screening at 8 weeks.); Conners Parent (completed by parent about child) (Change form Screening at 8 weeks.); Conners Teacher Rating Scale (completed by teacher about child) (Change from Screening at 8 weeks.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme - a Randomised Phase II Trial
Brief Summary: This study is designed to evaluate the impact of radiotherapy target volume delineation based on AA-PET compared to target volume delineation based on contrast enhanced T1 weighted MRI (T1Gd-MRI) on the clinical outcome of patients with recurrent glioblastoma (GBM) as well as concerning therapeutic safety of the respective strategy.


Options:
A: Progression Free Survival (PFS) (6 months after randomization)
B: 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)
C: Progression Free Survival (up to 142 weeks)
D: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)

Answer: A