TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
Brief Summary: The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.


Options:
A: Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) (Baseline up to Week 16 (End of Study (EoS])); Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) (Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing)); Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) (Baseline, Week 8 (2 Weeks of Follow Up))
B: The mean Hb level during the evaluation period (From week 33 to 36); The change in mean Hb level during the evaluation period from baseline (Baseline and week 33 to 36)
C: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
D: United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy (Baseline (Day 1, Week 0), Weeks 28 to 52); Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy (Baseline up to Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Double-blind Cross-over Trial Evaluating the Role of Frequencies on Spinal Cord Stimulation in the Management of Failed Back Surgery Syndrome (SCS Frequency Study)
Brief Summary: The purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).


Options:
A: Changes in pain (6 months)
B: Visual Analog Scale (VAS) on Back Pain (12 weeks)
C: Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
D: Group difference in pain intensity (6 weeks after baseline); Change from baseline in intra-network connectivity in the Default Mode Network (6 months after baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Double-blind Cross-over Trial Evaluating the Role of Frequencies on Spinal Cord Stimulation in the Management of Failed Back Surgery Syndrome (SCS Frequency Study)
Brief Summary: The purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).


Options:
A: Difference between treatment groups in responder rates. (3 Months)
B: Pain intensity according to numeric rating scale (NRS) (3 months after implantation)
C: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)
D: Visual Analog Scale (VAS) on Back Pain (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Double-blind Cross-over Trial Evaluating the Role of Frequencies on Spinal Cord Stimulation in the Management of Failed Back Surgery Syndrome (SCS Frequency Study)
Brief Summary: The purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).


Options:
A: Mean VAS Back Pain (7 Day Subject VAS Pain Diary) (6 months post randomisation)
B: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)
C: Visual Analog Scale (VAS) on Back Pain (12 weeks)
D: Responder Rate (3 months post-activation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Pharmaceutical Care in Patients With Bipolar I Disorder at St John of God Clinic. Randomized Trial.
Brief Summary: This project aims, through pharmaceutical care in patients with Bipolar I Disorder, improve compliance and adherence rate, associated with greater effectiveness and safety of drug therapy to help achieve therapeutic goals, and finally to improving the quality of life of patients.


Options:
A: To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations (1 year); To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations (1 year); To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits (1 year)
B: Metabolic Syndrome (MetS) (Baseline)
C: Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators. (First a Pilot in 3 months and then the final study in 6 months)
D: Self-reported medication adherence (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endoscopic Resection of High Grade(TA, T1, Cis)Non-muscle Invasive Bladder Tumors: Modification of Usual Management of This Resection by Using the Blue Light and Evaluation of the Outcome: Should we Maintain the Dogma of Second Endoscopic Resection as a Principle?
Brief Summary: To confirm the benefit of endoscopic resection under fluorescence and blue light of high grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection recommended nowadays can be deleted.


Options:
A: Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 (Two years)
B: Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light (Day 0); Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months. (9 months)
C: Recurrence-Free Survival (RFS) (Up to 4 years)
D: Number of extra lesions revealed by blue light compared to the resection performed in white light (2 to 6 weeks after resection)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior
Brief Summary: The goal of the Strongest Families Finland Canada project is to help parents develop skills to strengthen their families and reduce disruptive behavior in their 4 year old children.


Options:
A: CHild Behaviour Checklist (to measure change from baseline) (Measure change from baseline at 6 & 12 months)
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: Engagement (Participants will be followed for the duration of treatment, an expected average of 10 weeks)
D: Retention (Baseline to Post-Intervention (average 8 to 12 weeks)); Mean % Sessions Attended as Scheduled (Baseline to Post-Intervention (average 8 to 12 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-label Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Brief Summary: The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.


Options:
A: Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA). (At one month (M1) after Dose 2); Concentrations of Antibodies Against Anti-gE as Determined by ELISA. (At one month (M1) after Dose 2)
B: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody (Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)); Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers (Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)); Geometric Mean Titers of H1N1-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of H3N2-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4)); Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody (Baseline and 4 weeks after Influenza vaccination (Week 4))
C: Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations (One month after dose 2, at Month 3); Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) (During the 30-day (Days 0-29) period after each dose.); Number of Subjects With Any and Related Serious Adverse Events (SAEs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)); Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3))
D: GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) (6 weeks after IP(Investigational Product) vaccination); GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA (6 weeks after IP(Investigational Product) vaccination)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-label Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Brief Summary: The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.


Options:
A: Reduce burden of illness due to herpes zoster (HZ) (Incidence of postherpetic neuralgia (PHN), where PHN is defined as HZ-associated pain greater than or equal to 3 persisting or appearing more than 30 days after the onset of the HZ rash)
B: Number of Subjects With Vaccine Response to Anti-gE Antibodies (At one month post-dose 2 (Month 3)); Vaccine Response for Anti-gE Humoral Immunogenicity (At one month post-dose 2 (Month 3)); Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies (At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)); FLU Haemagglutination Inhibition (HI) Antibody Titers (At Day 21 post vaccination)
C: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))
D: Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA). (At one month (M1) after Dose 2); Concentrations of Antibodies Against Anti-gE as Determined by ELISA. (At one month (M1) after Dose 2)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrating Substance Abuse Assessment & Intervention in Primary Care Settings
Brief Summary: The purposes of this study are to: 1) implement a high fidelity Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol with computerized screening technology into three primary care clinics in urban Philadelphia; 2) conduct a randomized controlled trial to determine if an expanded SBIRT (SBIRT+) will help patients attend more specialty substance abuse treatment sessions and reduce substance use compared to SBIRT; 3) conduct a process evaluation of SBIRT+ at the three collaborating clinics consisting of focus groups and structured interviews to assess implementation barriers and workforce attitudinal shifts; and 4) provide an excellent clinical research training environment for undergraduate and graduate students from Lincoln University.


Options:
A: Compare the NCMIT and SCMT programs among homeless young gay and bisexual stimulant using men with respect to completion of a HBV vaccination series administered in three doses over a four-month period. (5 years)
B: Self-reported frequency of distributive sharing of injection and non-injection drug equipment (i.e., lending, giving or selling used needles, syringes or paraphernalia to others)
C: Readiness to change alcohol and other drug use (Baseline and 13-14 weeks (post intervention)); Readiness to change risky sexual behavior (Baseline and 13-14 weeks (post intervention)); Self efficacy to change alcohol and other drug use (Baseline and 13-14 weeks (post intervention)); Self efficacy to change risky sexual behavior (Baseline and 13-14 weeks (post intervention)); Self-efficacy to change social networks (Baseline and 13-14 weeks (post intervention)); Perceived Social Network support and approval/disapproval of alcohol, drug use, and risky sex. (Baseline and 13-14 weeks (after intervention))
D: Change in Treatment Session Attendance from Baseline (0, 3, 6, 9, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhanced Motor Recovery Using Serotonergic Agents in Stroke
Brief Summary: The information derived from this study will be critical to establishing appropriate rehabilitative interventions post-stroke. In particular, traditional use of pharmacological agents to alter motor function post-stroke is directed primarily at reducing the "positive" signs following upper motor neuron lesion, in particular spasticity, or enhanced, velocity-dependent stretch reflex responses to imposed stretch. While pharmacological management of spasticity certainly suppresses clinical and quantitative measures of hypertonia, there is little improvement in functional performance. In contrast, preliminary data on the administration of 5HT agents following neurological injury indicates an increase in motor performance (Pariente 2001) and recovery (Dam 1996), despite an increase in spastic motor activity (Stolp-Smith 1999; see Preliminary Data below). Understanding methods to maximize function following stroke despite potential, short-term increases in spastic motor activity may improve therapeutic intervention strategies. The general objective of this study is therefore to:

1. quantify the effects of short-term SSRI administration on voluntary and spastic motor behaviors in individuals with chronic spastic hemiparesis,
2. identify the changes in impairments and functional recovery of walking ability during BWSTT with the presence or absence of SSRIs.


Options:
A: Changes in Motor Function (Jebsen-Taylor Task) (baseline and 90 days); Changes in Fugl-Meyer Assessment (FMA) Scale (baseline and 90 days)
B: Peak treadmill speed (4 weeks)
C: Functional status, measured with the modified Rankin scale. (6 months)
D: Fugl Meyer Motor Scale score (Baseline and 90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhanced Motor Recovery Using Serotonergic Agents in Stroke
Brief Summary: The information derived from this study will be critical to establishing appropriate rehabilitative interventions post-stroke. In particular, traditional use of pharmacological agents to alter motor function post-stroke is directed primarily at reducing the "positive" signs following upper motor neuron lesion, in particular spasticity, or enhanced, velocity-dependent stretch reflex responses to imposed stretch. While pharmacological management of spasticity certainly suppresses clinical and quantitative measures of hypertonia, there is little improvement in functional performance. In contrast, preliminary data on the administration of 5HT agents following neurological injury indicates an increase in motor performance (Pariente 2001) and recovery (Dam 1996), despite an increase in spastic motor activity (Stolp-Smith 1999; see Preliminary Data below). Understanding methods to maximize function following stroke despite potential, short-term increases in spastic motor activity may improve therapeutic intervention strategies. The general objective of this study is therefore to:

1. quantify the effects of short-term SSRI administration on voluntary and spastic motor behaviors in individuals with chronic spastic hemiparesis,
2. identify the changes in impairments and functional recovery of walking ability during BWSTT with the presence or absence of SSRIs.


Options:
A: Peak treadmill speed (4 weeks)
B: Occurrence rate of depression (3 months)
C: Vascular death, Transient Ischemic Attack (TIA)/stroke and myocardial infarction (combined) (6 months); Functional status at 6-months (6 months)
D: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project.
Brief Summary: The purpose of this study is to determine whether an integrated EmONC package (community mobilization, training of community-based health care providers and a maternal and neonatal health pack) reduce perinatal and neonatal mortality.


Options:
A: Perinatal mortality (12 months)
B: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
C: contraception (past 3 months)
D: delayed bathing of baby (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project.
Brief Summary: The purpose of this study is to determine whether an integrated EmONC package (community mobilization, training of community-based health care providers and a maternal and neonatal health pack) reduce perinatal and neonatal mortality.


Options:
A: Neonatal mortality rate
B: Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
C: Perinatal mortality (12 months)
D: perinatal mortality (Jan 1999-Dec 2003)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tele-rehabilitation of Heart Patients
Brief Summary: The idea behind the Teledi@log consortium is to develop tele-rehabilitation concepts and technologies so that all types of heart disease patients, regardless of degree of severity, can be offered individual, customized and coordinated tele-rehabilitation across sectors. The project is innovative, breaking new ground in relation to existing national and international research projects in the area. The Teledi@log consortium sees its major task as developing and testing scenarios which can lead to a more coherent rehabilitation for heart patients in areas such as patient training, organization across the boundaries of the health system and using tele-rehabilitation technology. The Teledi@log consortium seeks to develop new tele-rehabilitation concepts which bring the patient closer to the health system and thereby promote the heart patient's rehabilitation, giving the patient and their families a more active role via new tele-rehabilitation technologies.The hypothesis of the study is that heart patients participating in a telerehabilitation program will have a higher quality of life compared to heart patients following traditional rehabilitation activities.


Options:
A: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
B: Change from baseline peak VO2 (ml/kg/min) at 12 week (Baseline, 12 week); Change from baseline MLHFQ at 12 week (Baseline,12 week)
C: Quality of life (At inclusion (baseline), change from baseline at 3, 6 and 12 months)
D: Change in self-care behaviour measured with the validated European Heart Failure Self Care Behaviour Scale(EHFScB scale) (at 3, 6 and 12 months); Change in health related quality of life measured with the generic short-form health survey with 36 questions (SF36), EuroQol five Dimensions (EQ-5D) and the disease-specific Minnesota Living with Heart Failure Questionnaire (MLHFQ) (at 3, 6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tele-rehabilitation of Heart Patients
Brief Summary: The idea behind the Teledi@log consortium is to develop tele-rehabilitation concepts and technologies so that all types of heart disease patients, regardless of degree of severity, can be offered individual, customized and coordinated tele-rehabilitation across sectors. The project is innovative, breaking new ground in relation to existing national and international research projects in the area. The Teledi@log consortium sees its major task as developing and testing scenarios which can lead to a more coherent rehabilitation for heart patients in areas such as patient training, organization across the boundaries of the health system and using tele-rehabilitation technology. The Teledi@log consortium seeks to develop new tele-rehabilitation concepts which bring the patient closer to the health system and thereby promote the heart patient's rehabilitation, giving the patient and their families a more active role via new tele-rehabilitation technologies.The hypothesis of the study is that heart patients participating in a telerehabilitation program will have a higher quality of life compared to heart patients following traditional rehabilitation activities.


Options:
A: Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period (0, 12 and 52 weeks)
B: Quality of life (At inclusion (baseline), change from baseline at 3, 6 and 12 months)
C: Change in Mean Daily Steps (Baseline and end of Maintenance Period at Week 16)
D: Maximal oxygen consumption (At baseline and after 6 months)

Answer: B