TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring Two Emotion-Focused Treatment Modules in Non-Suicidal Self-Injury
Brief Summary: The overall aim of this study is to begin establishing an effective treatment for individuals who engage in non-suicidal self-injury (NSSI), as there are currently no evidence-based treatments that directly target this problematic behavior. Existing treatments that have demonstrated initial promise in reducing NSSI consist of many skills embedded in complex programs; therefore, the skill(s) responsible for improvements in NSSI are not clear. Procedures that focus on one's emotions, particularly that aim to increase emotional awareness and engagement in cognitive reappraisal (i.e., a way of thinking that lessens emotions), may be critical in effective NSSI treatment. The specific goals of this study are to investigate the effects of two specific emotion-focused treatment elements on NSSI. Participants will be ten individuals who meet the proposed Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5; American Psychiatric Association) criteria for NSSI disorder and engage in NSSI to reduce or escape from negative emotions. Two core modules of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011) will be adapted and delivered with the aim of reducing participants' non-suicidal self-injurious thoughts and behaviors. Each treatment module will consist of four 50-minute individual weekly sessions of emotion awareness training or cognitive reappraisal. The study will use a single-case experimental design, and phase change will be determined based on each participant's changes in non-suicidal self-injurious thoughts and behaviors.


Options:
A: Frequency of non-suicidal self-injurious thoughts and behaviors (Daily (up to 126 days))
B: Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months (Baseline, 6 month and 12 month follow up)
C: Repeat Suicide Attempts (1, 3, 6, and 12 months)
D: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring Two Emotion-Focused Treatment Modules in Non-Suicidal Self-Injury
Brief Summary: The overall aim of this study is to begin establishing an effective treatment for individuals who engage in non-suicidal self-injury (NSSI), as there are currently no evidence-based treatments that directly target this problematic behavior. Existing treatments that have demonstrated initial promise in reducing NSSI consist of many skills embedded in complex programs; therefore, the skill(s) responsible for improvements in NSSI are not clear. Procedures that focus on one's emotions, particularly that aim to increase emotional awareness and engagement in cognitive reappraisal (i.e., a way of thinking that lessens emotions), may be critical in effective NSSI treatment. The specific goals of this study are to investigate the effects of two specific emotion-focused treatment elements on NSSI. Participants will be ten individuals who meet the proposed Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5; American Psychiatric Association) criteria for NSSI disorder and engage in NSSI to reduce or escape from negative emotions. Two core modules of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011) will be adapted and delivered with the aim of reducing participants' non-suicidal self-injurious thoughts and behaviors. Each treatment module will consist of four 50-minute individual weekly sessions of emotion awareness training or cognitive reappraisal. The study will use a single-case experimental design, and phase change will be determined based on each participant's changes in non-suicidal self-injurious thoughts and behaviors.


Options:
A: Frequency of non-suicidal self-injurious thoughts and behaviors (Daily (up to 126 days))
B: Parasuicidal behaviour (intermittent)
C: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm (16 weeks and 68 weeks); Severity of suicidal ideation, level of depressive symptoms (16 weeks and 68 weeks)
D: Time to Suicide Attempt (Up to 18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endometrial Receptivity Enhancement Through Induced Injury and Repair During Ovarian Stimulation in an Antagonist Down-regulated Cycle
Brief Summary: A randomised controlled open-label clinical trial to assess the effect of artificially induced endometrial injury and repair during ovarian stimulation on the clinical pregnancy rate of an antagonist downregulated in-vitro fertilisation cycle


Options:
A: Clinical pregnancy rate (12 weeks)
B: Impact of next generation sequencing on the embryos produced from IVF on implantation rates (2 years)
C: improvement in ongoing implantation rates (When a fetal heartbeat is detected for each patient. (8 weeks after implantation).)
D: Implantation ratio (Six months); Clinical pregnancy ratio (six months); Live birth ratio (six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Switching From Usual Brand Cigarettes to a Tobacco-heating Cigarette or Snus - A Multi-center Evaluation of Health-related Quality of Life Assessments and Biomarkers of Exposure and Harm
Brief Summary: To evaluate selected biomarkers of tobacco exposure and biomarkers of harm and assess quality of life measures in smokers randomly switched from their usual brand of cigarette to one of three test products: (1) a tobacco-heating cigarette; (2) snus (smokeless tobacco); or (3) an ultra-low machine yield tobacco-burning cigarette.


Options:
A: Concentration of Monohydroxybutenylmercapturic Acid (MHBMA) (5 days); Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) (5 days); Concentration of S-phenylmercapturic Acid (S-PMA) (5 days); Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL) (90 days); Levels of Carboxyhemoglobin (COHb) (5 days)
B: Levels of High Density Lipoprotein C (HDL-C). (26 Weeks); Levels of White Blood Cells (WBC). (26 Weeks); Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1). (26 Weeks); Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1). (26 Weeks); Concentrations of 11-dehydrothromboxane B2 (11-DTXB2). (26 Weeks); Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α). (26 Weeks); Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL). (26 Weeks); Percent Change From Baseline of Carboxyhemoglobin (COHb) (26 Weeks)
C: Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 12 (Week 12); Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 12 (Week 12); Change in Markers of Exposure and Potential Harm from Weeks 0 to 12 (Week 12); Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 12 (Week 12); Change in tobacco usage diary from Weeks 0 to 4 (Week 4); Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 24 (Week 24); Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 24 (Week 24); Change in Markers of Exposure and Potential Harm from Weeks 0 to 24 (Week 24); Change in daily tobacco usage diary from Weeks 4 to 8 (Week 8); Change in daily tobacco usage diary from Weeks 8 to 12 (Week 12); Change in daily tobacco usage diary from Weeks 12 to 16 (Week 16); Change in daily tobacco usage diary from Weeks 16 to 20 (Week 20); Change in daily tobacco usage diary from Weeks 20 to 24 (Week 24); Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 24 (Week 24)
D: Number of Participants With Smoking Cessation (12 WEEK)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
Brief Summary: This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine \[OPV\] and diphtheria, tetanus, and acellular pertussis vaccine \[DTaP\]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.


Options:
A: Number of Participants With Any Severity of Rotavirus Gastroenteritis (From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months))
B: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
C: Seroprotection for each polio serotype 1 month after the 3rd dose.
D: Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
Brief Summary: This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine \[OPV\] and diphtheria, tetanus, and acellular pertussis vaccine \[DTaP\]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.


Options:
A: Laboratory-confirmed episode of severe rotavirus gastroenteritis (From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained)
B: Occurrence of RV GE
C: Number of Participants With Any Severity of Rotavirus Gastroenteritis (From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months))
D: Any adverse event in adult cohort (Up to two weeks after single dose of vaccine or placebo); Serious adverse events in adult cohort (Up to two weeks after single dose of vaccine or placebo); Any adverse event in infant cohort (Up to one month after 3 doses of vaccine or active control); Serious adverse events in infant cohort (Up to one month after 3 doses of vaccine or active control)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
Brief Summary: This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine \[OPV\] and diphtheria, tetanus, and acellular pertussis vaccine \[DTaP\]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.


Options:
A: Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus (Up to 2 years of age)
B: Number of Participants With Any Severity of Rotavirus Gastroenteritis (From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months))
C: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet and Prevention of Ischemic Heart Disease: a Translational Approach
Brief Summary: The objective of this study is to test the effect of substitution dietary guidelines that are specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in the general Danish population.


Options:
A: Laboratory findings and body composition (2 years)
B: N/A
C: Dietary intake (6 month)
D: Hemoglobin A1c (22 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet and Prevention of Ischemic Heart Disease: a Translational Approach
Brief Summary: The objective of this study is to test the effect of substitution dietary guidelines that are specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in the general Danish population.


Options:
A: Dietary intake (6 month)
B: Non-alcoholic Fatty Liver Disease Ultrasonography Score (Six months)
C: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
D: body weight in kilograms as measured by a calibrated scale (0,1,2,3,4,5,and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet and Prevention of Ischemic Heart Disease: a Translational Approach
Brief Summary: The objective of this study is to test the effect of substitution dietary guidelines that are specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in the general Danish population.


Options:
A: Incident Cancer (12/31/2030); All cause and disease specific mortality (12/31/2030); Chronic diseases (12/31/2030)
B: Dietary intake (6 month)
C: Cardiovascular Disease Prevention based on dietary approach. (Two years)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet and Prevention of Ischemic Heart Disease: a Translational Approach
Brief Summary: The objective of this study is to test the effect of substitution dietary guidelines that are specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in the general Danish population.


Options:
A: Dietary intake (6 month)
B: Hemoglobin A1c (22 weeks)
C: Fat mass (Baseline - 12 weeks)
D: Change in body weight (measured at Year 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet and Prevention of Ischemic Heart Disease: a Translational Approach
Brief Summary: The objective of this study is to test the effect of substitution dietary guidelines that are specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in the general Danish population.


Options:
A: body weight in kilograms as measured by a calibrated scale (0,1,2,3,4,5,and 6 months)
B: Dietary intake (6 month)
C: body fat composition (0, 6,18 months); obesity (0, 6, 18 months); abdominal obesity (0, 6, 18 months)
D: Fat mass, lean mass, bone mass (BMD, BMC), total mass (measured via DXA scan) (Measured at weeks 0, 8 and 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Ephedrine to Reduce Fetal Bradycardia After Combined Spinal Epidural Labor Analgesia: a Randomized Double Blind Placebo-controlled Study
Brief Summary: The combined spinal epidural (CSE) technique has become increasingly popular for labor pain because of its rapid onset and superior first stage analgesia. However, increased risk for early profound fetal bradycardia (EPFB) following CSE continues to be a concern. Various factors are implicated in the etiology of EPFB but the cause is unknown. Ephedrine administration prior to CSE analgesia may help reduce the risk of EPFB, but to date, nobody has studied the impact of a single dose of intravenous (IV) ephedrine given at the time of CSE administration during labor. The purpose of this study is to measure the incidence of EPFB after combined spinal epidural analgesia using standard definitions. The incidence of EPFB will be compared between patients who receive prophylactic ephedrine or placebo at the time of CSE placement.


Options:
A: Early Profound Fetal Bradycardia (Within 30 minutes of combined spinal epidural (CSE) placement)
B: Incidence of hypotension (Time between induction of spinal anesthesia until delivery)
C: Frontal lobe cerebral oxygenation (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour); Foetal heartrate (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour)
D: Number of Participants with Adverse Events as a Measure of Safety and Tolerability" (day 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Ephedrine to Reduce Fetal Bradycardia After Combined Spinal Epidural Labor Analgesia: a Randomized Double Blind Placebo-controlled Study
Brief Summary: The combined spinal epidural (CSE) technique has become increasingly popular for labor pain because of its rapid onset and superior first stage analgesia. However, increased risk for early profound fetal bradycardia (EPFB) following CSE continues to be a concern. Various factors are implicated in the etiology of EPFB but the cause is unknown. Ephedrine administration prior to CSE analgesia may help reduce the risk of EPFB, but to date, nobody has studied the impact of a single dose of intravenous (IV) ephedrine given at the time of CSE administration during labor. The purpose of this study is to measure the incidence of EPFB after combined spinal epidural analgesia using standard definitions. The incidence of EPFB will be compared between patients who receive prophylactic ephedrine or placebo at the time of CSE placement.


Options:
A: The time required to remain sitting after spinal anesthesia (start with 3 minutes after completion of spinal then we ll go up or down)
B: Frontal lobe cerebral oxygenation (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour); Foetal heartrate (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour)
C: Early Profound Fetal Bradycardia (Within 30 minutes of combined spinal epidural (CSE) placement)
D: Incidence of hypotension (Time between induction of spinal anesthesia until delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
Brief Summary: The investigators will test the impact of a decision aid, Head CT Choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to the emergency department with blunt head trauma.


Options:
A: N/A
B: preferences (at time of interview)
C: Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury (Day 1 (immediately after the clinical encounter))
D: Hemoglobin A1c (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a French Maritim Pine Bark Extract Oligopin® on Blood Pressure: Double Blind, Crossover, Placebo-controlled Nutrition Intervention Trial
Brief Summary: The objective of the study is to evaluate the effect of consumption of a food supplement rich in procyanidins extracted from the bark of French pine, Oligopin®, on blood pressure of people with mild / moderate degree of hypertension. Furthermore, the effect Oligopin® consumption on markers involved in the development of hypertension, and endothelial function in key enzymes that regulate blood pressure, inflammation and oxidation are considered. Also, try to advance the understanding of the molecular mechanisms that regulate blood pressure.


Options:
A: Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta "lnRHI") (Intervention period of 4 weeks)
B: Differences detected on the time evolution of BP both in two arms of intervention (5 weeks)
C: Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12. (three months)
D: Summed ADHD score of the ADHD-Rating Scale as rated by teachers (10 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome
Brief Summary: The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.


Options:
A: Progression Free Survival (PFS) (up to approx. 18 months)
B: Central Review-based Progression-Free Survival (Up to 3 years)
C: Progression Free Survival (PFS) (7 months after the last patient enrolled)
D: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period (First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.1 Weeks)); Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels (Baseline and 12 Weeks); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period (First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 52.6 Weeks))

Answer: D