TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia
Brief Summary: The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.


Options:
A: Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) (Randomization to Week 19); Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event (Randomization to Week 19)
B: To evaluate the efficacy of pregabalin (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale
C: Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score (Week 4); Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score (Week 12 (end of treatment))
D: Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial
Brief Summary: According to current evidence and psychological theorizing, the provision of information seems to be a promising way to reduce the anxiety of patients that is related to their scheduled ICU stay. An ICU-specific information program will be investigated in a randomized controlled clinical trial involving 120 patients undergoing elective open heart surgery and 20 patients undergoing abdominal surgery. It is expected that the patients in the test group will experience less anxiety and ICU related discomfort than patients in the control group.


Options:
A: Patient self-reported anxiety (First three days on ICU and/or within 24 hours after ICU discharge)
B: Patient self-reported anxiety (after admission on standard ward); ICU related discomfort (after admission on standard ward)
C: length of stay and depression (ICU admission, Day 5, discharge, and 2 months)
D: Patient Health Questionaire (PHQ-9) (At 3- and 6- months following the death of the patient)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.
Brief Summary: Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.


Options:
A: Bacterial colony counts and the frequency with which methicillin-resistant Staphylococcus aureus was found over time (8 hours)
B: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
C: Invasive Infection (Participants will be followed during their NICU hospitalization, an expected average of 3 months); Necrotizing enterocolitis (NEC) (Participants will be followed for their entire NICU hospitalization, which is an average of 3 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.
Brief Summary: Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.


Options:
A: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
B: Main Outcome: Patients With Nosocomial MRSA Clinical Cultures (The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.)
C: ICU-Ecology (27 months)
D: To compare ventilator associated pneumonia rates in patients receiving early enteral feeding without residual gastric volume (RGV) monitoring and in patients with RGV monitoring (until weaning of mechanical ventilation (average : 14 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.
Brief Summary: Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.


Options:
A: A composite of healthcare-associated infections (Daily)
B: N/A
C: Colonization with MRSA, VRE and ESBL (On admission); Colonization with MRSA, VRE and ESBL (During ICU stay)
D: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effect of Oral Immune-Enhancing Nutritional Supplement on Hepatic Function After Liver Resection for Primary or Secondary Cancer on Cirrhosis or Liver Fibrosis
Brief Summary: Cirrhotic patients undergoing hepatic resection have a mortality rate near 10%, and 30 to 70% of them develop severe complications. These failures are mainly due to hepatic insufficiency. Studies have already shown benefits of oral nutritional supplements in ORL, digestive, and cardiac surgery. We aimed to ascertain whether this nutritional, immune-enhancing supplementation, administered 7 days before and 3 days after surgery, could improve liver function and postoperative host defences in patients with liver cancer resection.


Options:
A: To study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery. (3-6 months)
B: Factor V at day 3 after surgery (day 3)
C: Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) (Number of hours post surgery)
D: improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life. (while in the waiting list for liver transplantation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy Combination With Other Oral Anti-diabetic Agents
Brief Summary: The purpose of the study is to see how safe and effective and tolerable the use of WelChol® is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic drugs


Options:
A: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
B: To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
C: - To assess the additional lowering of HbA1c achieved by; addition of WelChol® to current antidiabetic therapy
D: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Stratified, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of the ACAT Inhibitor CS-505 for Reducing the Progression of Atherosclerosis in Subjects With Heterozygous Familial Hypercholesterolemia and Carotid Atherosclerosis Using Carotid Ultrasound (CUS)
Brief Summary: The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.


Options:
A: Stroke and death (4 years)
B: To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis.
C: absolute changes in carotid intima-media thickness from baseline to final visit (12 months)
D: Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT) (Baseline, 6 months, 12 months, 18 months, and 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
Brief Summary: The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.


Options:
A: Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85 (At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).); Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months) (Day MP-365 (12 months) of maintenance therapy); Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs (Between Day OL-1 and Day OL-617); OL; Number of Participants With Adverse Events (AEs) of Special Interest (Between Day OL-1 and Day OL-617)
B: Remission without steroids, immunosuppressives and without colectomy (week 16)
C: Treatment emergent adverse events (Throughout the study period of approximately 2 year, 4 months)
D: Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point (Week 10)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
Brief Summary: The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.


Options:
A: Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) (6 months)
B: Treatment emergent adverse events (Throughout the study period of approximately 2 year, 4 months)
C: Rate of non-emergence of bloody stool (Week 48)
D: Number of Participants Who Achieved Clinical Remission at Day 56 (Baseline up to Day 56)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multi-center, Open-label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD


Options:
A: Treatment emergent adverse events over 12 months. (Weekly)
B: Incidence of adverse events; Changes in physical examinations, clinical laboratory tests, vital signs, sleep quality, appetite, and tics
C: The change from survey day 1 to first visit in Clinical Global Impression score (3 weeks)
D: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose (Hour 4 post-dose)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.


Options:
A: SKAMP deportment rating scale (Week 8)
B: N/A
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: Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 (Baseline, 8 weeks); Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group (Baseline, 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.


Options:
A: Executive function test (seven to ten weeks)
B: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
C: SKAMP deportment rating scale (Week 8)
D: ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) (Measured at baseline Week 4 and Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIB, Randomized, Double-blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old 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: SKAMP deportment rating scale (Week 8)
C: Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9). (12-hours from 8:00 am to 8:00 pm)
D: Attention Deficit Hyperactivity Disorder Total Symptom Score (End of placebo dose week, End of low dose week, End of medium dose week , End of high dose week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Open-Label, Multi-Center Study Evaluating the Safety and Tolerability of Methylphenidate Transdermal System (MTS) in Children Aged 6-12 Previously Treated With Extended-Release Methylphenidate Product.
Brief Summary: This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.


Options:
A: Score on ADHD Rating Scale at 4 weeks (30 days)
B: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)
C: ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) (Measured at baseline Week 4 and Week 8)
D: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) (From baseline (visit 2) to end of of Double-Blind phase (visit 3))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
Brief Summary: The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects the participants sleep and how they perceive their quality of life.


Options:
A: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Baseline (following ADHD medication washout of 7-28 days)); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 1); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 2); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 3); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 4); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 5); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 6)
B: Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks (Baseline and 7 weeks)
C: 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.)
D: Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. (Baseline, and the Endpoint (average of weeks 5, 6, 7).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Effectiveness of Intermittent Preventive Treatment Delivered Through the Expanded Programme of Immunisation for Malaria and Anaemia Control in Tanzanian Infants
Brief Summary: The safety and efficacy of Intermittent Preventive Treatment for malaria and anaemia control in Infants (IPTi) have already been documented in Southern Tanzania, affording an opportunity to gain operational experience in developing a strategy for the longer-term implementation of IPTi. Working in conjunction with national and district-based health authorities, a strategy will be developed to make IPTi available through routine health services and an effectiveness evaluation conducted. This will be based on the comparison of process and outcome indicators in areas with and without IPTi. Information on safety will be consolidated and the effect of IPTi on the rate of development of drug resistance explored. The acceptability and costs of implementing IPTi will be monitored and combined with assessments of effectiveness (in terms of morbidity and mortality) to assess the cost-effectiveness of IPTi.


Options:
A: Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age (15 months); Incidence of symptomatic P. falciparum malaria from 3 - 15 months of age (15 months); Incidence of symptomatic P. vivax malaria from 3-15 months of age (!5 months)
B: N/A
C: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
D: Mortality rate in children aged 2-11 months (estimated by birth history questioning) (Up to 12 months of age); Incidence of severe adverse drug reactions following IPTi (as detected by spontaneous, passive reporting system) (All age groups, particular attention in under 2 year olds)

Answer: D