TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Adding Metoclopramide and Ondansetron to a Prophylactic Phenylephrine Infusion for the Management of Nausea and Vomiting Associated With Spinal Anesthesia for Cesarean Section
Brief Summary: The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.


Options:
A: Occurrence of Intra-operative and Post-operative Vomiting (During surgery (1 hour) and thru 72 hours after surgery)
B: Intraoperative blood loss (mL) (20 minutes); Postoperative Hemoglobin (gm/L) (20 minutes)
C: Incidence of Nausea and Vomiting (intraoperative 2-3 hours); Incidence of Nausea and Vomiting (2 hrs postoperative); Incidence of Nausea and Vomiting (24hrs postoperative)
D: Intraoperative Nausea and Vomiting (Intraoperatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Multicenter Phase II/III Study Comparing 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced Resectable Adenocarcinoma of the Esophagogastreal Junction or the Stomach
Brief Summary: Patients with locally advanced resectable adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Epirubicin, Cisplatin and 5-FU (ECF). Main objective of the study is median overall survival.


Options:
A: Time to progression (The time from randomization until objective tumor progression or death)
B: median survival
C: median overall survival (2 years follow-up)
D: Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) (From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)); Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) (From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)); Percentage of Participants Who Died: Second Interim Analysis (From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)); Overall Survival: Second Interim Analysis (Co-primary Endpoint) (From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)); Percentage of Participants Who Died: Final Analysis (From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)); Overall Survival: Final Analysis (From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)); Percentage of Participants Who Were Alive at Year 1 (Year 1); Percentage of Participants Who Were Alive at Year 2 (Year 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-management for Dual Sensory Impaired Older People and Their Caregivers: an Effective Approach?
Brief Summary: This study aims to determine the effectiveness of a self-management program for elderly with an acquired and concurrent hearing and visual impairment due to age-related disease processes.


Options:
A: Fall Related Process Measures (6 months post intervention)
B: Reductions in hospitalization (1 year)
C: Participation in social, leisure and communicative activities. (6 months)
D: cumulative number of hospitalisation (within 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Thymoglobulin to Prevent Chronic Graft Versus Host Disease in Patients Undergoing Hematopoietic Progenitor Cell Transplantation (HPCT) From Unrelated Donors
Brief Summary: This is a randomized trial for patients undergoing hematopoietic progenitor cell transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled will receive Thymoglobulin® as part of the preparative regimen prior to HPCT. The other 50% of the patients enrolled will receive a standard preparative regimen. Thymoglobulin is known to suppress the types of cells that can cause a transplant complication known as "chronic graft versus host disease (cGVHD)". The goal of this trial is to find out if adding Thymoglobulin to the preparative regimen will result in a decrease in cGVHD.


Options:
A: Freedom from Chronic GVHD (12 months post transplant)
B: Overall Response Rate (ORR) at Day 28 (Day 28)
C: Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups (180 days after HCT)
D: Incidence of acute GVHD, and chronic GVHD (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Placebo Controlled Study of PH94B for Management of the Symptoms of Generalized Social Phobia
Brief Summary: The purpose of this study is to determine the efficacy of PH94B, a new class of therapeutic compound, administered intranasally for the management of acute anxiety in patients diagnosed with generalized social phobia.


Options:
A: Change in Liebowitz Social Anxiety Scale (LSAS) - total score (Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks)
B: To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment.
C: Superiority is defined as a statistically greater reduction of the mean change from baseline to endpoint (after 12 weeks of treatment) in the Liebowitz Social Anxiety Scale (LSAS) total score.
D: Subjective Unit of Discomfort Scale (Once before and again 10 minutes after intranasal dosing with PH94B spray, during exposure to a public speaking challenge)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Implantable Cardioverter-Defibrillator (ICD) Utilization in a Potentially Eligible VA Population
Brief Summary: Despite being a proven life-saving intervention in appropriately selected individuals, multiple studies continue to demonstrate low implantation of defibrillators in potential candidates. Based upon prior research, a major barrier to low utilization is low referral of potential candidates by healthcare providers. In this study, via brief clinical reminder placed in the electronic medical record, we ask healthcare providers who have not referred potential candidates for defibrillator the reasons for this decision and provide them with the tools for referral if appropriate.


Options:
A: HbA1c (6 months)
B: Change in screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling (Baseline and 1 Year)
C: Referral for Implantable Cardioverter Defibrillator (6 months)
D: Quality of otitis media care. (18 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Implantable Cardioverter-Defibrillator (ICD) Utilization in a Potentially Eligible VA Population
Brief Summary: Despite being a proven life-saving intervention in appropriately selected individuals, multiple studies continue to demonstrate low implantation of defibrillators in potential candidates. Based upon prior research, a major barrier to low utilization is low referral of potential candidates by healthcare providers. In this study, via brief clinical reminder placed in the electronic medical record, we ask healthcare providers who have not referred potential candidates for defibrillator the reasons for this decision and provide them with the tools for referral if appropriate.


Options:
A: Referral for Implantable Cardioverter Defibrillator (6 months)
B: Symptomatic venous thromboembolic events and severe haemorrhage (3 months)
C: influenza vaccination (September through March 2011-2012)
D: Compliance rates with care guidelines (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
Brief Summary: This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).


Options:
A: Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye (Baseline, Month 1 through Month 3)
B: N/A
C: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
D: The difference from baseline in mean Best Corrected Visual Acuity (BCVA) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Clinical Trial to Determine the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis
Brief Summary: The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis (PGD) increases implantation and delivery rates in couples attempting to conceive through in vitro fertilization (IVF).


Options:
A: live born delivery rate (at birth of the child)
B: Ongoing Pregnancy (Gestational Age of 20 Weeks)
C: The Percentage of Patients With a Live Birth (>20 weeks gestation)
D: Sustained Implantation Rate Per Embryo Transferred (Within 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Invasive Revascularization or Not in Intermittent Claudication
Brief Summary: Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent claudication (CI) affecting\> 10% of individuals\> 65 years. A recent Swedish Health Technology Assessment Report identified only limited evidence for the effectiveness of invasive treatment for IC in patients already on exercise training. The prognosis for the extremity is usually benign and treatment therefore aims at improving quality of life. Invasive treatment can also cause serious complications. Coronary artery disease is common in IC patients increasing the risk with invasive treatment. In spite of these uncertain merits and potential risks, invasive procedures for IC are increasing and 37% of all invasive procedures for PAD in Sweden are performed for IC. The aim of this study is to evaluate the additional effects of modern invasive treatment in patients with intermittent claudication receiving modern best medical treatment (BMT). The primary hypothesis in the study is that invasive treatment in addition to BMT improves health related quality of life and walking performance compared to BMT only.


Options:
A: maximum walking distance (one year)
B: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)
C: Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD) (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment); Ankle brachial pressure indices(ABPI) measured at rest and post exercise (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment)
D: Health Related Quality of Life (HRQOL) (24 months with intermistic analysis at 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial
Brief Summary: In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a \>50% stenosis or occlusion of the SFA over \>/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.


Options:
A: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)
B: Primary (and -assisted) patency (5 years); Quality of life (5 years)
C: (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass (5 year)
D: Clinical improvement (12 Month Post Operatively); Patency rate (12 Month Post Operatively); Cost effectiveness (12 Month Post Operatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Randomized control trial studying the effect of medical assistant health coaching for patients with diabetes, hypertension and hyperlipidemia within two San Francisco primary care community clinics, Mission Neighborhood Health Center and Southeast Health Center


Options:
A: Severity of depressive symptoms (7 Days)
B: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)
C: Weight change
D: Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Randomized control trial studying the effect of medical assistant health coaching for patients with diabetes, hypertension and hyperlipidemia within two San Francisco primary care community clinics, Mission Neighborhood Health Center and Southeast Health Center


Options:
A: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)
B: Work limitations (One year); Work engagement (One year)
C: Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL (12 months)
D: All-cause mortality (within 5 years of enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD
Brief Summary: The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD within a double-blind cross-over design over six weeks. The assessment of ADHD followed formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A neuropsychological testbattery and four behavioral questionnaires were selected as efficacy variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory control, motor activity), Score (auditory attention), Stroop Test (processing speed, inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed by a parent and a teacher Monday till Friday through every week), Test Performance Questionnaire (completed by the child immediately after each of the three test sessions).

Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will provide better results than a trial including only Met. a)Met and Dex are efficient as treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to Met. b)At an individual level some of the participants will show positive response to one type of stimulants and no response, mixed response or adverse response to the other type of stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in agreement but also add unique information in the assessment of the effect of stimulants. d)Qb-test is sensitive and valid as a measure of the effect of stimulants.


Options:
A: Conners' Global Index - Parent Version (CGI-P) (Once weekly during the medication trial); Conner's Global Index - Teacher Version (CGI-T) (Once weekly during the medication trial)
B: N/A
C: Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. (Baseline and 4 weeks); Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM. (Baseline and 4 weeks)
D: Change in ADHD and ODD symptoms (Every week for six weeks); Change in attention, motor activity and executive functioning (The neuropsychological tests are administered once on each type of medication during the six week trial); Change in side-effects (Once every week through the six week trial)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD
Brief Summary: The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD within a double-blind cross-over design over six weeks. The assessment of ADHD followed formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A neuropsychological testbattery and four behavioral questionnaires were selected as efficacy variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory control, motor activity), Score (auditory attention), Stroop Test (processing speed, inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed by a parent and a teacher Monday till Friday through every week), Test Performance Questionnaire (completed by the child immediately after each of the three test sessions).

Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will provide better results than a trial including only Met. a)Met and Dex are efficient as treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to Met. b)At an individual level some of the participants will show positive response to one type of stimulants and no response, mixed response or adverse response to the other type of stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in agreement but also add unique information in the assessment of the effect of stimulants. d)Qb-test is sensitive and valid as a measure of the effect of stimulants.


Options:
A: SKAMP-Combined Scores (2 hours post-dose)
B: Onset of Effect of Vyvanse (Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.)
C: Change in ADHD and ODD symptoms (Every week for six weeks); Change in attention, motor activity and executive functioning (The neuropsychological tests are administered once on each type of medication during the six week trial); Change in side-effects (Once every week through the six week trial)
D: Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks (Baseline and 7 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD
Brief Summary: The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD within a double-blind cross-over design over six weeks. The assessment of ADHD followed formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A neuropsychological testbattery and four behavioral questionnaires were selected as efficacy variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory control, motor activity), Score (auditory attention), Stroop Test (processing speed, inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed by a parent and a teacher Monday till Friday through every week), Test Performance Questionnaire (completed by the child immediately after each of the three test sessions).

Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will provide better results than a trial including only Met. a)Met and Dex are efficient as treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to Met. b)At an individual level some of the participants will show positive response to one type of stimulants and no response, mixed response or adverse response to the other type of stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in agreement but also add unique information in the assessment of the effect of stimulants. d)Qb-test is sensitive and valid as a measure of the effect of stimulants.


Options:
A: Change in ADHD and ODD symptoms (Every week for six weeks); Change in attention, motor activity and executive functioning (The neuropsychological tests are administered once on each type of medication during the six week trial); Change in side-effects (Once every week through the six week trial)
B: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) (Hour 4 of the of the Lab School Day during Double-Blind Assessment Period); Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) (Hour 4 of the Lab School Day During the Double-Blind Assessment Period)
C: Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score. (Last week of 3-week treatment period assessed at Visit 5.)
D: Number of days of use of cannabis (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
Brief Summary: The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.


Options:
A: The difference between the response rates of the treatment and control groups. (3-months post randomization)
B: Quality of Life Assessment. (Three + Months Follow-Up Visit)
C: Change in Percent Volume of Lung (12 weeks following treatment)
D: Forced Vital Capacity (FVC) (6 months); modified Medical Research Council (mMRC) score (breathlessness) (6 months)

Answer: B