TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
Brief Summary: The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)
B: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))
C: 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.)
D: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
Brief Summary: The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)
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: 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)
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: A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
Brief Summary: The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Hospitalization for gastroenteritis (2 years)
B: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)
C: Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.
D: 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.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Indicated Prevention With Omega-3 Fatty Acids in Adolescents With 'At-Risk-Mental-State' for Psychosis: A Randomised, Double Blind, Placebo-Controlled Treatment Trial
Brief Summary: Early intervention in psychosis might be associated with better outcomes. However, intervention in the pre-psychotic phase has been questioned as, using current criteria, only 20-50% of individuals classified as prodromal develop a psychotic disorder within a 1-2 years period. Treatment agents investigated in the pre-psychotic phase of schizophrenia and other psychotic disorders should, therefore, not have major side effects. This proposal investigates omega-3 fatty acids (1.2 gramm per day eicosapentaenoic acid/docosahexaenoic acid;EPA/DHA) as a beneficial and possible preventive therapeutic agent in young people at ultra high-risk for developing a psychotic disorder.


Options:
A: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)
B: Transition to PANSS defined first-episode psychosis (Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months)
C: PTSD Symptoms (CAPS, SCID, PDS, IESR) (1.5 years)
D: Measures of impulsivity, aggression, affective impulsivity, immediate and delayed memory, and cognitive processing at baseline, 6 months and 9 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Indicated Prevention With Omega-3 Fatty Acids in Adolescents With 'At-Risk-Mental-State' for Psychosis: A Randomised, Double Blind, Placebo-Controlled Treatment Trial
Brief Summary: Early intervention in psychosis might be associated with better outcomes. However, intervention in the pre-psychotic phase has been questioned as, using current criteria, only 20-50% of individuals classified as prodromal develop a psychotic disorder within a 1-2 years period. Treatment agents investigated in the pre-psychotic phase of schizophrenia and other psychotic disorders should, therefore, not have major side effects. This proposal investigates omega-3 fatty acids (1.2 gramm per day eicosapentaenoic acid/docosahexaenoic acid;EPA/DHA) as a beneficial and possible preventive therapeutic agent in young people at ultra high-risk for developing a psychotic disorder.


Options:
A: Psychotic Symptoms (two years)
B: transition to subthreshold psychosis (and psychosis or schizophrenia)
C: Transition to PANSS defined first-episode psychosis (Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months)
D: Incidence of Remission From Attenuated Psychosis Syndrome (APS) Within a 52-week Timeframe (Up to 52 weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone
Brief Summary: The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients.


Options:
A: DAS28-ESR remission at 24 weeks (at 24 week); Changes over time in the number of patients maintaining discontinuation (maintenance rate) (Week 52 to Week 104)
B: Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24.
C: EULAR individual response (12 months)
D: MRI synovitis, bone edema and erosions score (baseline, week 18 and 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone
Brief Summary: The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients.


Options:
A: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.
B: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))
C: Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12
D: MRI synovitis, bone edema and erosions score (baseline, week 18 and 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone
Brief Summary: The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients.


Options:
A: Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12
B: MRI synovitis, bone edema and erosions score (baseline, week 18 and 52)
C: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
D: Percentage of patients with ACR 20 response (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone
Brief Summary: The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
B: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 (Baseline and 52 Weeks); Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 (Baseline and Week 52)
C: MRI synovitis, bone edema and erosions score (baseline, week 18 and 52)
D: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Influence of High-Dose Aprotinin and Tranexamic Acid on Bleeding Tendency and Allogeneic Blood Transfusion in Patients Undergoing Primary Aortic Valve Replacement or Coronary Artery Revascularization
Brief Summary: The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of increased postoperative bleeding.Only patients undergoing first time CABG or first time aortic valve replacement are included in this study.


Options:
A: Number of allogenic blood units transfused (Measured through the 8th postoperative day)
B: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
C: Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) (1 Week)
D: 24 hours postoperative drainage blood loss; incidence of allogeneic blood transfusion

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Trial of a Video That Presents Training in Stress Coping Skills for Caregivers of a Relative With Alzheimer's Disease or Other Dementia
Brief Summary: The purpose of this Phase II SBIR study is a) to complete the adaptation begun in Phase I of the ten skill modules of the Williams LifeSkills Video (WLV) for use by persons who are caregivers for a relative with Alzheimer's Disease (AD) or other dementia, b) to script and produce the complete Caregiver LifeSkills Video (CLV) and c) to conduct a randomized clinical trial of the completed CLV to document benefits in terms of reduced psychosocial distress, reduced biomarkers of stress and improved well being.


Options:
A: Change from Baseline in Health Related Quality of Life at One, Three and Six Months (One, three and six months)
B: Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977) (Baseline and weeks 6 and 10; 3-months and 6-months post)
C: Center for Epidemiological Studies Depression scale (Pre- and post-training, 3 months and 6 months); Spielberger State-Trait Anger and Anxiety Scales (Pre-and post-training, 3 months and 6 months); Perceived Stress Scale (Pre- and post-training, 3 months and 6 months); Pittsburgh Sleep Quality Index (Pre-and post-training, 3 months and 6 months); Heart rate and blood pressure at rest and during recall of caregiver situation (Pre-and post-training, 3 months and 6 months); Salivary cortisol upon awakening, 30 minutes later, and prior to going to bed at night (Pre-and post-training, 3 months and 6 months)
D: Effects of the WeCareAdvisor Tool on Caregiver Upset (4 weeks); Effect of the WeCareAdvisor Tool on Caregiver Confidence (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
Brief Summary: Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. Despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. Previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures.

Aims of study: 1. To characterize the pain response of infants by using a computerized analysis of the ECG. 2. To compare six different methods of pain reduction during heel lancing in newborns.

Methods: The time, geometric and frequency domains of the infants' ECG will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. The differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.


Options:
A: Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p < 0.001. (At two years)
B: pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS) (Immediately after vaccination)
C: infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
Brief Summary: Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. Despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. Previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures.

Aims of study: 1. To characterize the pain response of infants by using a computerized analysis of the ECG. 2. To compare six different methods of pain reduction during heel lancing in newborns.

Methods: The time, geometric and frequency domains of the infants' ECG will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. The differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.


Options:
A: Cortical oxy-haemoglobin increase (During the procedure)
B: N/A
C: Pain scores assessed by the PIPP score (The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.)
D: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
Brief Summary: Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. Despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. Previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures.

Aims of study: 1. To characterize the pain response of infants by using a computerized analysis of the ECG. 2. To compare six different methods of pain reduction during heel lancing in newborns.

Methods: The time, geometric and frequency domains of the infants' ECG will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. The differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.


Options:
A: Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p < 0.001. (At two years)
B: Pain measured on PIPP (Premature Infant Pain Profile) scale (4 week to complete)
C: N/A
D: Neonatal Infant Pain Scale (NIPS) (6 MONTHS); State Anxiety Inventory (SAI) (6 MONTHS)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The study plans to compare the glucose-lowering effect of gurmar, a herbal preparation, with metformin in patients with type 2 diabetes


Options:
A: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 Weeks)
B: N/A
C: Steady State Beta Cell Compensation (24 months)
D: Time to first occurence of a confirmed composite endpoint of death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer. (Time to first event during study period (for each patient 24-48 months, mean 36 months ))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Psychological and Psychophysiological Effects of a Biofeedback-based Cognitive-behavioral Psychotherapy for Chronic Tinnitus-sufferers
Brief Summary: The study aims to develop and to evaluate a psychophysiological intervention for distressing chronic tinnitus. Therefore 100 people suffering from chronic tinnitus are randomly assigned to either an intervention-group, receiving 12 sessions of a psychophysiological oriented intervention, or to a waiting-list-group, who are waiting for a comparable time period. Afterwards, patients of the waiting-list-group also receive intervention. The effects of the intervention on severity, distress and perceived loudness of the tinnitus as well as on other psychological variables like depression or self-efficacy are evaluated through comparing the results of the intervention group with those of the waiting-list-group.

Additionally the psychophysiological reactivity under different stress-conditions is measured before and after intervention or waiting. Therefore the activity of the muscles of head and shoulders (EMG) as well as the skin temperature and skin conductance are measured. It is hypothesized that patients with stronger psychophysiological reactivity benefit more from an psychophysiological intervention.


Options:
A: The Tinnitus Functional Index (Assessed at baseline and 8 weeks post-intervention)
B: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (At baseline and 3, 8 and 12 months follow-up)
C: Tinnitus Functional Index (TFI) (Change will be assessed at 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2). The change will be assessed at every test moment.)
D: Tinnitus Questionnaire German Version; Tinnitus diary

Answer: D