TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer
Brief Summary: RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.

PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.


Options:
A: Global Response Assessment (GRA) (12 Weeks)
B: Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits (at end of treatment, 15 weeks from baseline assessment)
C: Average Joint Pain According to BPI-SF (Weeks 2, 6, 12, and 24; Week 12 reported)
D: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer
Brief Summary: RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.

PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.


Options:
A: To evaluate patient willingness to use STAR (Symptom Tracking and Reporting for Patients), an Internet-based system for cancer patients to self-report common toxicity symptoms, performance status, and quality of life. (conclusion of study); To evaluate the impact of STAR on clinical outcomes (2 years)
B: Disease free survival. (Up to end of year 2015)
C: Change from baseline in musculoskeletal pain and 250HD levels (3 monthly during one year)
D: Average Joint Pain According to BPI-SF (Weeks 2, 6, 12, and 24; Week 12 reported)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-Term Outcome of N-Carbamylglutamate in the Treatment of Acute Hyperammonemia
Brief Summary: The overall objective of this drug trial is to determine whether the treatment of acute hyperammonemia with N-carbamyl-L-glutamate (NCG, Carglumic acid) in propionic acidemia (PA), methylmalonic acidemia (MMA), late-onset CPS1 deficiency (CPSD) and late-onset Ornithine transcarbamylase deficiency (OTCD) accelerates the resolution of hyperammonemia efficiently and safely.

The primary goal is to determine if the study drug (NCG) efficiently reduces ammonia levels following a hyperammonemia episode(s).

Secondly, the investigators want to know if treatment with this study drug (NCG) efficiently improves neurologic function, reduces plasma glutamine levels and lessens the duration of hospitalization after each episode of hyperammonemia.


Options:
A: Growth (5 years)
B: 1. Weight of abnormal (watery/liquid) stool for each 6-hour and 24-hour (day) of the study as well as cumulative weight until resolution of diarrhoea (maximum of 5 days) (12 months)
C: Blood Amino Acid levels and Frequency of Cholestasis in Neonates (At baseline, day 7, 14, 21 and 28 of the administration of total parenteral nutrition (TPN)
D: Time to the Primary Outcome (Earlier of Ammonia <50 µmol/L or Hospital Discharge) (Average of all measurements of hyperammonemia, for up to 7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose Ranging Safety and Efficacy Study of FG 4592 in Non-dialysis Chronic Kidney Disease (CKD) Subjects With Anemia
Brief Summary: The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in non-dialysis chronic kidney disease patients.


Options:
A: Maximum change in hemoglobin by Week 9 from baseline (Week 9)
B: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis) (Up to 4.3 person-years for CV follow-up time period); Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))
C: Modeled Hgb Change From Baseline Over 4 Weeks of Treatment (Baseline (average of Week -2, -1 and Day 1) and Week 4)
D: Rate of rise in hemoglobin (g/dL/week) (Baseline and at Week-6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-month, Phase IIIb, Open-label, Randomized, Active Controlled, 3-arm, Multicenter Study Assessing the Efficacy and Safety of an Individualized, Stabilization-criteria-driven PRN Dosing Regimen With 0.5-mg Ranibizumab Intravitreal Injections Applied as Monotherapy or With Adjunctive Laser Photocoagulation in Comparison to Laser Photocoagulation in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion
Brief Summary: This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.


Options:
A: Changes in best spectacle-corrected visual acuity (BSCVA) (from baseline to month 6)
B: change in central retinal thickness (six months compared to baseline)
C: N/A
D: Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) (Baseline, 6 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Spaulding-Harvard Spinal Cord Injury (SH-SCI) Study: Effects of tDCS on Chronic Pain in Spinal Cord Injury.
Brief Summary: The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with spinal cord injury. This study is part of the Spaulding-Harvard Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 1 week of stimulation (5 consecutive days) followed by 2 weeks of stimulation (10 consecutive days) after a 3-month follow up visit. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation.

If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.


Options:
A: Numeric Rating Scale (NRS) for Pain (baseline); Numeric Rating Scale (NRS) for Pain (day 5); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (baseline); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (day 5); Six-minute Walk Test (baseline); Six-minute Walk Test (day 5); Short Physical Performance Battery (SPPB) (baseline); Short Physical Performance Battery (SPPB) (day 5); Heat Pain Threshold (baseline); Heat Pain Threshold (day 5); Heat Pain Tolerance (baseline); Heat Pain Tolerance (day 5); Pressure Pain Threshold (baseline); Pressure Pain Threshold (day 5); Punctate Mechanical Pain Sensitivity (baseline); Punctate Mechanical Pain Sensitivity (day 5); Conditioned Pain Modulation (CPM) (baseline); Conditioned Pain Modulation (CPM) (day 5)
B: Analgesic efficiency (36 months)
C: Changes in the Visual Analog Scale for Phantom Limb Pain (4 weeks)
D: Change in Pain Scale (Measured for approximately 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Spaulding-Harvard Spinal Cord Injury (SH-SCI) Study: Effects of tDCS on Chronic Pain in Spinal Cord Injury.
Brief Summary: The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with spinal cord injury. This study is part of the Spaulding-Harvard Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 1 week of stimulation (5 consecutive days) followed by 2 weeks of stimulation (10 consecutive days) after a 3-month follow up visit. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation.

If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.


Options:
A: Average Pain (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE HAMILTON DEPRESSION RATING SCALE (HRDS) (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up)
B: Change in pain Scores as measured by the Visual Analog Scale (2 months)
C: Pain severity (up to three months after the end of treatment)
D: Change in Pain Scale (Measured for approximately 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: BAX 855 (PEGylated Recombinant Factor VIII): A Phase 1, Prospective, Open Label, Cross-Over, Dose-Escalation Study in Previously Treated Patients (PTPs) With Severe (FVIII < 1%) Hemophilia A
Brief Summary: The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.


Options:
A: To assess the safety of systemic administration of a novel self-complementary AAV vector in adults with severe hemophilia B at up to four different dosage levels. (15 years)
B: Serious and non-serious AEs (4 weeks after infusion with BAX 855 and ADVATE)
C: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (up to 52 weeks ± 1 week); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Incidence Rate of FIX Inhibitor Development (up to 52 weeks ± 1 week); Annualized Bleeding Rate (up to 52 weeks ± 1 week (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates (up to 52 weeks ± 1 week (efficacy period as defined in description))
D: Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings (Baseline up to Week 52); Number of Participants With Clinically Significant Change From Baseline in Vital Signs (Baseline up to Week 52); Number of Participants With Clinical Laboratory Abnormalities Reported as TEAE (Baseline up to Week 52); Number of Participants With Drug -Related TEAEs and Serious Adverse Events (SAEs) (Baseline up to Week 52); Number of Participants With Positive Immune Reponses Against Adeno-associated Virus Vector (AAV) Capsid (Baseline up to Week 52); Number of Participants Who Reached > 150% Vector-derived FIX:C Activity Level After SPK-9001 Infusion (Baseline up to Week 52); Number of Participants With FIX Inhibitor (Baseline up to Week 52); Incremental Recovery of FIX Product (Day 0 and Week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: BAX 855 (PEGylated Recombinant Factor VIII): A Phase 1, Prospective, Open Label, Cross-Over, Dose-Escalation Study in Previously Treated Patients (PTPs) With Severe (FVIII < 1%) Hemophilia A
Brief Summary: The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.


Options:
A: Annualized Bleeding Rate (ABR) (9 months)
B: N/A
C: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)
D: Serious and non-serious AEs (4 weeks after infusion with BAX 855 and ADVATE)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
Brief Summary: A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.


Options:
A: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] (42 days after vaccination 3 (up to 185 days))
B: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)
C: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))
D: Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody (At Month 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
Brief Summary: A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.


Options:
A: Primary study endpoint: acute rotavirus diarrhoea occurring from 6 weeks of age to the end of the follow-up period in subjects who resided in randomized villages during the period when they were age-eligible to have received Rotarix. (24 months)
B: 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)
C: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.
D: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] (42 days after vaccination 3 (up to 185 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
Brief Summary: A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.


Options:
A: Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] (42 days after vaccination 3 (up to 185 days))
B: Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. (On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.)
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: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Visual Cue Training to Improve Walking and Turning After Stroke: a Pilot Study
Brief Summary: Given that visual information comprises one of the most important and salient sources of information used during walking, that visual cues have been shown to be more effective than auditory cues in triggering gait adjustments and that stroke survivors have been reported to become more dependent on visual cues, the investigators hypothesize that visual cues would be more effective in triggering gait recovery and adaptability following stroke than interventions not including visual cues.

The investigators will integrate visual cues with walking and turning practice, and contrast this intervention to routine overground walking practice. Stroke participants recruited from NHS stroke rehabilitation clinics in the West Midlands, will be randomized to one of three gait rehabilitation groups. Each group will receive the same frequency and duration of treatment delivered by qualified physiotherapists. Overground visual cue training (OVCT) and usual care (UC) groups will be treated in participating NHS sites. Treadmill training with visual cues (TVCT) will take place at the University of Birmingham.


Options:
A: VA LV VFQ-48 Reading Domain Scores (4 months from baseline)
B: activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) (5 and 17 weeks); distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ)) (5 and 17 weeks)
C: Static Balance (Week 0 and Week 8.)
D: Participant enrollment, recruitment and retention. (Ongoing for18 months after start of recruitment.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Visual Cue Training to Improve Walking and Turning After Stroke: a Pilot Study
Brief Summary: Given that visual information comprises one of the most important and salient sources of information used during walking, that visual cues have been shown to be more effective than auditory cues in triggering gait adjustments and that stroke survivors have been reported to become more dependent on visual cues, the investigators hypothesize that visual cues would be more effective in triggering gait recovery and adaptability following stroke than interventions not including visual cues.

The investigators will integrate visual cues with walking and turning practice, and contrast this intervention to routine overground walking practice. Stroke participants recruited from NHS stroke rehabilitation clinics in the West Midlands, will be randomized to one of three gait rehabilitation groups. Each group will receive the same frequency and duration of treatment delivered by qualified physiotherapists. Overground visual cue training (OVCT) and usual care (UC) groups will be treated in participating NHS sites. Treadmill training with visual cues (TVCT) will take place at the University of Birmingham.


Options:
A: Total score in a neglect test battery (Change from baseline at Day 8 (post-treatment)); Functional independence score (Change from baseline at Day 8 (post-treatment))
B: Overall Proportion Saying "Yes" to Real Prism Glasses (Evaluated after 4 weeks of wearing each type of prism glasses)
C: Participant enrollment, recruitment and retention. (Ongoing for18 months after start of recruitment.)
D: Total "dose" of intervention received as a proportion of the scheduled time (10 days over a 2 week period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial
Brief Summary: The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.


Options:
A: Total number of days alive and off respiratory support in the first 28 days (28 days); Serum vitamin D concentration (Day after birth 28)
B: Change From Baseline in Serum 25OHD (During the 7-month follow-up period)
C: Serum concentration of 25(OH) D at 36 weeks postmenstrual age. (36 weeks); Prevalence of vitamin D deficiency at 36 weeks postmenstrual age. (36 weeks)
D: Parental and infant preference for a new vitamin D delivery system over the standard of care supplement in syrup form. (21 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial
Brief Summary: Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most conventional drug which was proved effective. However, it has the shortcomings of short half life and the necessity of intravenous administration. Misopristol, and more recently Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.

Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin for treatment of atonic PPH.


Options:
A: control of postpartum hemorrhage (within 20 minutes of administration)
B: Hb of greater than or equal to 2 g/dl from pre- to post-delivery (3-5 days after delivery)
C: Need for other uterotonics (2 minutes after giving the drug)
D: Need for other uterotonics (2 minutes after giving the drug)

Answer: A