TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain
Brief Summary: Severe pre-amputation pain is associated with phantom pain development, and phantom pain models assign major importance to central and peripheral nervous system changes related to pre-amputation pain. Several interventions have been evaluated for phantom pain prevention, including continuous brachial plexus blockade5, intravenous6 or epidural ketamine administration, postoperative perineural ketamine/clonidine infusion8 and oral gabapentin9, but their true effect remains unclear.


Options:
A: occurrence of chronic pain (3 months)
B: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
C: Evaluation of chronic postsurgical pain. (After 3 and 12 months of surgery.)
D: analgesic consumption of level 3 in the two treated groups (24 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind, Placebo Controlled Study for the Study of the Effectiveness of Perioperative Analgesia in Phantom and Stump Pain
Brief Summary: Severe pre-amputation pain is associated with phantom pain development, and phantom pain models assign major importance to central and peripheral nervous system changes related to pre-amputation pain. Several interventions have been evaluated for phantom pain prevention, including continuous brachial plexus blockade5, intravenous6 or epidural ketamine administration, postoperative perineural ketamine/clonidine infusion8 and oral gabapentin9, but their true effect remains unclear.


Options:
A: Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. (1, 6, 24 & 48 hours); The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. (1, 6, 24 & 48 hours); Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively (1, 6, 24 & 48 hours)
B: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
C: Endometriosis associated pain (By the clinician after 1, 2 and 3 months ; by the patient daily for 3 months)
D: The primary aim of this study was to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. (April, 2007)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Longitudinal Follow Up of Subjects Enrolled in Randomized Trials of Prenatal and Infancy Home Visitation
Brief Summary: The Elmira follow-up study is designed to assess the extent to which prenatal and infancy home visitation by nurses affects the life-course development of 19-year-old youth whose mothers received those services during pregnancy and the first two years of the child's life.


Options:
A: Retention (Baseline to Post-Intervention (average 8 to 12 weeks)); Mean % Sessions Attended as Scheduled (Baseline to Post-Intervention (average 8 to 12 weeks))
B: Engagement (Participants will be followed for the duration of treatment, an expected average of 10 weeks)
C: rates of pregnancy and out-of-wedlock child birth (At age 19); educational achievement, including graduation from high school and participation in various types of post-high school education (At age 19); participation in the work force, including enrollment in the armed services (At age 19); use of welfare (At age 19); use of substances (cigarettes, alcohol, and illegal drugs) (At age 19); involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) (At age 19)
D: CHild Behaviour Checklist (to measure change from baseline) (Measure change from baseline at 6 & 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Longitudinal Follow Up of Subjects Enrolled in Randomized Trials of Prenatal and Infancy Home Visitation
Brief Summary: The Elmira follow-up study is designed to assess the extent to which prenatal and infancy home visitation by nurses affects the life-course development of 19-year-old youth whose mothers received those services during pregnancy and the first two years of the child's life.


Options:
A: Food Intake (9 month posttest, 21 month follow-up, 33 month follow-up); Physical Activity (baseline, 9 month posttest, 21 month posttest, 33 month posttest); Body Mass Index (baseline, 9 month posttest, 21 month posttest, 33 month posttest)
B: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
C: the number and spacing of subsequent pregnancies and births (When first child is 12); the rates of marriage and cohabitation with the father of the child (When first child is 12); mothers' employment, career growth, economic self-sufficiency, and welfare dependence (When first child is 12); mothers' behavioral problems due to substance abuse (When first child is 12); children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement (At age 12); rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children (At age 12); mothers' arrests for serious misdemeanors and felonies (When first child is 12)
D: rates of pregnancy and out-of-wedlock child birth (At age 19); educational achievement, including graduation from high school and participation in various types of post-high school education (At age 19); participation in the work force, including enrollment in the armed services (At age 19); use of welfare (At age 19); use of substances (cigarettes, alcohol, and illegal drugs) (At age 19); involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) (At age 19)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Longitudinal Follow Up of Subjects Enrolled in Randomized Trials of Prenatal and Infancy Home Visitation
Brief Summary: The Elmira follow-up study is designed to assess the extent to which prenatal and infancy home visitation by nurses affects the life-course development of 19-year-old youth whose mothers received those services during pregnancy and the first two years of the child's life.


Options:
A: Time Line Follow Back and urine screen (Pre and post-treatment, 3 and 6 month follow-ups)
B: rates of pregnancy and out-of-wedlock child birth (At age 19); educational achievement, including graduation from high school and participation in various types of post-high school education (At age 19); participation in the work force, including enrollment in the armed services (At age 19); use of welfare (At age 19); use of substances (cigarettes, alcohol, and illegal drugs) (At age 19); involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) (At age 19)
C: Smoking cessation: quit and reduction rates (6 months)
D: the number and spacing of subsequent pregnancies and births (When first child is 12); the rates of marriage and cohabitation with the father of the child (When first child is 12); mothers' employment, career growth, economic self-sufficiency, and welfare dependence (When first child is 12); mothers' behavioral problems due to substance abuse (When first child is 12); children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement (At age 12); rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children (At age 12); mothers' arrests for serious misdemeanors and felonies (When first child is 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Prospective Study of the Safety of Rituximab in Combination With Other Disease-Modifying Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis
Brief Summary: This is a Phase III, open-label study of a total of approximately 560 subjects with active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Enrollment in the study was conducted in two stages. In Stage I of the study, approximately 400 subjects receiving non-biological DMARDs (with the exception of methotrexate \[MTX\] monotherapy or MTX and leflunomide combination therapy) were enrolled. In Stage II of the study, approximately 160 subjects receiving a Federal Drug Administration-approved biological DMARD at the time of screening were enrolled.


Options:
A: Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine (Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B)
B: Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment (From first treatment with rituximab (Day 1) through Week 24)
C: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
D: Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response (Baseline to the end of the retreatment period (up to 7 years, 6 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double Blind Controlled Trial of the Efficacy and Safety of POLYCAP (Quintapill)Versus Its Components in Subjects With at Least One Additional Cardiovascular Risk Factor
Brief Summary: STUDY TITLE A randomized double-blind controlled trial of the efficacy and safety of the POLYCAP® versus its components in subjects aged 45 to 80 years of age with at least one additional cardiovascular risk factor.

STUDY OBJECTIVES This study is designed to assess the efficacy and safety of the POLYCAP®, a fixed dose combinationcontaining 5 drugs (an antiplatelet drug; 3 blood pressure lowering agents, a beta blocker, an ACE inhibitor, a diuretic and a statin.

STUDY DESIGN

Randomized controlled double-blind trial of the POLYCAP® versus its components in eight formulations.

STUDY POPULATION Subjects between 45 and 80 years of age, with at least one additional CVD risk factor.

INVESTIGATIONAL PRODUCTS Composition POLYCAP® and its comparators FOLLOW UP The total duration of follow up will be 4 months, from the start of study medication.. Subjects will take study medication for 3 months. There will be a final follow up visit 1 month after stopping the study medication.

There will be five follow up visits, the first 7 - 10 days after starting study medication and thereafter monthly visits for 4 months. Subjects taking any of the study medications prior to enrolment will have one or more additional visits during a defined wash out and before enrolment.

OUTCOME MEASURES Mean difference of change in BP, LDL and urinary thromboxane at the end of the three month period.

STATISTICAL ISSUES Non-inferiority evaluation of the POLYCAP in modifying BP, lipids and platelet activity \[as measured by urinary thromboxane\] when compared with its different components in eight different formulations.


Options:
A: Reduction in blood Pressure (12 weeks); reduction in Heart Rate (12 weeks); modify lipids (12 weeks)
B: Reduction of the Estimated 10-year Total Cardiovascular Risk Score (Six months)
C: Number of patients who reach target blood pressure (From baseline to the end of the 3-month study period)
D: Major Cardiovascular Events (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double Blind Controlled Trial of the Efficacy and Safety of POLYCAP (Quintapill)Versus Its Components in Subjects With at Least One Additional Cardiovascular Risk Factor
Brief Summary: STUDY TITLE A randomized double-blind controlled trial of the efficacy and safety of the POLYCAP® versus its components in subjects aged 45 to 80 years of age with at least one additional cardiovascular risk factor.

STUDY OBJECTIVES This study is designed to assess the efficacy and safety of the POLYCAP®, a fixed dose combinationcontaining 5 drugs (an antiplatelet drug; 3 blood pressure lowering agents, a beta blocker, an ACE inhibitor, a diuretic and a statin.

STUDY DESIGN

Randomized controlled double-blind trial of the POLYCAP® versus its components in eight formulations.

STUDY POPULATION Subjects between 45 and 80 years of age, with at least one additional CVD risk factor.

INVESTIGATIONAL PRODUCTS Composition POLYCAP® and its comparators FOLLOW UP The total duration of follow up will be 4 months, from the start of study medication.. Subjects will take study medication for 3 months. There will be a final follow up visit 1 month after stopping the study medication.

There will be five follow up visits, the first 7 - 10 days after starting study medication and thereafter monthly visits for 4 months. Subjects taking any of the study medications prior to enrolment will have one or more additional visits during a defined wash out and before enrolment.

OUTCOME MEASURES Mean difference of change in BP, LDL and urinary thromboxane at the end of the three month period.

STATISTICAL ISSUES Non-inferiority evaluation of the POLYCAP in modifying BP, lipids and platelet activity \[as measured by urinary thromboxane\] when compared with its different components in eight different formulations.


Options:
A: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)
B: Reduction in blood Pressure (12 weeks); reduction in Heart Rate (12 weeks); modify lipids (12 weeks)
C: To evaluate the number of patients who reach target blood pressure (BP) and; LDL-C targets as defined by their governing guidelines.
D: Trough Seated Diastolic Blood Pressure (DBP) Control (End of study (34 weeks or last value on treatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of the Concomitant Use of a Live Pentavalent Rotavirus Vaccine (RotaTeq®) and a Meningococcal Group C Conjugate (MCC) Vaccine in Healthy Infants
Brief Summary: Primary objective:

To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.


Options:
A: Seroprotection for each polio serotype 1 month after the 3rd dose.
B: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
C: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)
D: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of the Concomitant Use of a Live Pentavalent Rotavirus Vaccine (RotaTeq®) and a Meningococcal Group C Conjugate (MCC) Vaccine in Healthy Infants
Brief Summary: Primary objective:

To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.


Options:
A: Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
B: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))
C: Percentage of Participants Developing New Grade >=3 Adverse Events (From study entry until at least 42 days after third vaccination); Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1. (Prior to first vaccination and at least 14 days after third vaccination)
D: 1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of the Concomitant Use of a Live Pentavalent Rotavirus Vaccine (RotaTeq®) and a Meningococcal Group C Conjugate (MCC) Vaccine in Healthy Infants
Brief Summary: Primary objective:

To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.


Options:
A: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)
B: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))
C: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))
D: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.


Options:
A: 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)
B: The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. (7 weeks)
C: Scores in the SNAP-IV (ADHD); Scores in the Young Mania Rating Scale (BD); Weight
D: Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items (end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.


Options:
A: 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.)
B: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (Baseline to Month-2)
C: The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. (7 weeks)
D: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points (0.75 up to 13 hours post-dose)

Answer: C