TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Proactive Psychosocial Treatment by the Case Manager in Patients After a Suicide Attempt: a Randomised Controlled Trial
Brief Summary: The purpose of this study is to determine the case manager are effective in the treatment of suicide attempters.


Options:
A: Social Processing (Cyberball) fMRI Task: fMRI Responses (Pre-treatment (baseline) and post-treatment (up to 2 weeks)); Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 1 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Ecological Momentary Assessment (EMA): NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 2 (pre-treatment (baseline) and post-treatment (up to 2 weeks)); Self Injurious Thoughts and Behaviors Inventory Part 3 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Self Injurious Thoughts and Behaviors Inventory Part 4 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline))
B: Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up (24 months)
C: Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 (The change from baseline at Week 10 in the total ZAN-BPD score was calculated using the MMRM model which is a longitudinal analyses and it incorporates ZAN-BPD measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.)
D: treatment adherence, defined as outpatient mental health clinic attendance (6-month, and 12-month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Proactive Psychosocial Treatment by the Case Manager in Patients After a Suicide Attempt: a Randomised Controlled Trial
Brief Summary: The purpose of this study is to determine the case manager are effective in the treatment of suicide attempters.


Options:
A: treatment adherence, defined as outpatient mental health clinic attendance (6-month, and 12-month)
B: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
C: Scale for Suicide Ideation Index (SSI) (Over 8 weeks of treatment); Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale (8 weeks of treatment)
D: Changes in Stages of Change Questionnaire, which measures motivation (3 months); Changes in Reasons for Living Inventory (3 months); Changes in State Hope Scale (3 months); Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness. (3 months); Changes in Beck Scale for Suicide Ideation (3 months); Suicide Attempt Self-Injury Count (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Proactive Psychosocial Treatment by the Case Manager in Patients After a Suicide Attempt: a Randomised Controlled Trial
Brief Summary: The purpose of this study is to determine the case manager are effective in the treatment of suicide attempters.


Options:
A: treatment adherence, defined as outpatient mental health clinic attendance (6-month, and 12-month)
B: Time to Fatal or Non-fatal Suicide Attempt or Self-Harm (18 Months after randomization)
C: Beck Depression Inventory (V2) (Baseline to 6 months)
D: Suicide Events (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: YUKON-drug-eluting Stent Below The Knee - Prospective Randomized Double-blind Multicenter Study
Brief Summary: The purpose of this study is to compare the effectiveness of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease.


Options:
A: Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis). (one year)
B: Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound) (12 months)
C: In-Segment Binary Restenosis (12-months)
D: The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention and Reduction of Obesity Through Active Living
Brief Summary: We will perform a randomized, controlled trial, the primary aim of which is to assess the effectiveness of a behavioral-based physical activity program in the prevention and treatment of obesity and related co-morbid conditions in a primary care setting. We hypothesize that the prevention and/or reduction of obesity and related co-morbidities in patients randomized to an individualized education and behavior counseling group will be greater by comparison to those randomized to a group that receives standard care alone.


Options:
A: Waist Circumference (2 Years)
B: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)
C: Primary outcomes are physical activity/exercise and body weight/ composition. Physical activity is assessed by accelerometry and standardized interview/questionnaire methods. Body composition is assessed by DXA (baseline, 4, 12, 16, 24 and 36 months)
D: Fasting Glucose (Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent Osteoporosis
Brief Summary: The purpose of this study is to determine whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women.


Options:
A: Self report daily diary of frequency and intensity of vasomotor symptoms at BL, 3, 6 and 12 months.; Wiklund Menopause Symptom Checklist at BL, 3, 6 and 12 months.
B: N/A
C: N/A
D: Bone mineral density (One year and two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Brief Summary: To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.

Hypothesize there will be no difference between formula groups.


Options:
A: Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes (10 years)
B: Intestinal permeability will be determined at the age of 3, 6, 9 and 12 months with the lactulose/mannitol test Intestinal permeability at the age of 9 months assessed with the lactulose/mannitol test (3, 6, 9 and 12 months)
C: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)
D: Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator (60 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Brief Summary: To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.

Hypothesize there will be no difference between formula groups.


Options:
A: Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes (10 years)
B: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)
C: Intestinal permeability will be determined at the age of 3, 6, 9 and 12 months with the lactulose/mannitol test Intestinal permeability at the age of 9 months assessed with the lactulose/mannitol test (3, 6, 9 and 12 months)
D: Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator (60 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Brief Summary: To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.

Hypothesize there will be no difference between formula groups.


Options:
A: Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator (60 days)
B: Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes (10 years)
C: infants' intake, length of feeding and patterning of feeding of Nutramigen relative to Enfamil (infant-led feeding condition) (0.5-8.5 months)
D: Growth (weight) (106 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment Approaches for Preeclampsia in Low-Resource Settings
Brief Summary: Preeclampsia is a condition unique to pregnancy characterized by the new onset of hypertension and proteinuria. Eclampsia, characterized by maternal seizures, is a serious complication increasing the risk of maternal and infant mortality and morbidity. Magnesium sulfate is the drug of choice for prevention and treating convulsions in severe preeclampsia and eclampsia.

Magnesium sulfate is administered parenterally by intramuscular (IM) or intravenous routes (IV). In general a loading dose of 4 to 5 grams of magnesium sulfate is administered intravenously followed by an IM injection every 4 hours or by a continuous IV infusion. The IV regimen achieves more stable serum levels of magnesium but requires the use of an infusion pump for safe delivery and has a greater potential for inadvertent overdose. Although magnesium sulfate has been demonstrated as a safe and effective drug for the treatment and prevention of severe preeclampsia and eclampsia, concerns about the safety of the drug remain. The IM dosing regimen, while potentially safer, requires repeated painful IM injections. These limitations in administration hinder the widespread use of magnesium sulfate despite its demonstrated benefits.

The goal of this research is to develop a system of care that avoids overdose and facilitates the use of magnesium sulfate for the treatment of preeclampsia. To this end, a primary objective of this research is to demonstrate the safety of a simple, inexpensive flow controlled pump system (Springfusor®). This randomized study will compare the administration of magnesium sulfate by the Springfusor® controlled pump with an IM regimen, the standard of care in most hospitals in India. The study will document the efficacy and acceptability of each treatment for patients and staff and compare the cost and time elements involved in providing each method.


Options:
A: completed course of treatment (24 hours postpartum)
B: Eclampsia (24 hours postpartum)
C: Maternal Serum Magnesium Level at 4 Hours After Administration (4 hours)
D: Seizure (Eclampsia) (72 hours postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With Clinically Isolated Syndrome (CIS)
Brief Summary: The primary objective is to assess the effect of treatment with glatiramer acetate (GA) compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the occurrence of the second clinical attack) during the double-blind period. The secondary objective is to assess, within the time frame of the up to 3-year double-blind, placebo-controlled study period, the effect of GA on clinical and Magnetic Resonance Imaging (MRI) parameters. The long-term objectives of the study (exploratory in nature) are to assess, within the time frame of 5 years, the neuroprotective effect of early versus delayed treatment with GA as reflected by clinical and MRI parameters measuring the accumulated irreversible brain tissue damage.

A pre-planned interim analysis was performed on all efficacy and safety data accumulated in the database up to October 14, 2007, i.e. when 81% of exposure to treatment in the double-blind, placebo-controlled period had been collected. Upon review of the interim analysis results, the Data Monitoring Committee (DMC) recommended that the double-blind portion of the study be stopped and that subjects be switched to the 2-year Open-label period, during which time they would have the option of receiving GA therapy. The sponsor (Teva) adopted the DMC recommendations and took the necessary action towards its implementation.


Options:
A: Time to First Relapse (Baseline up to 96 weeks)
B: Flu-like-syndrome (309 days); Injection-site Reactions (309 days); Liver Enzyme Elevations (309 days); Hematological Abnormalities (309 days)
C: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (Throughout study); Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (At Months 3, 6, and 12)
D: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion (up to 3 years); Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period (up to 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With Clinically Isolated Syndrome (CIS)
Brief Summary: The primary objective is to assess the effect of treatment with glatiramer acetate (GA) compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the occurrence of the second clinical attack) during the double-blind period. The secondary objective is to assess, within the time frame of the up to 3-year double-blind, placebo-controlled study period, the effect of GA on clinical and Magnetic Resonance Imaging (MRI) parameters. The long-term objectives of the study (exploratory in nature) are to assess, within the time frame of 5 years, the neuroprotective effect of early versus delayed treatment with GA as reflected by clinical and MRI parameters measuring the accumulated irreversible brain tissue damage.

A pre-planned interim analysis was performed on all efficacy and safety data accumulated in the database up to October 14, 2007, i.e. when 81% of exposure to treatment in the double-blind, placebo-controlled period had been collected. Upon review of the interim analysis results, the Data Monitoring Committee (DMC) recommended that the double-blind portion of the study be stopped and that subjects be switched to the 2-year Open-label period, during which time they would have the option of receiving GA therapy. The sponsor (Teva) adopted the DMC recommendations and took the necessary action towards its implementation.


Options:
A: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion (up to 3 years); Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period (up to 3 years)
B: Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time (up to 60 months after start of treatment); Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time (up to 60 months after start of treatment); Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60 (60 months after start of treatment)
C: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to 36 Months (Baseline (Day 1 of Study 27025) up to 36 Months)
D: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain (Week 12 to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With Clinically Isolated Syndrome (CIS)
Brief Summary: The primary objective is to assess the effect of treatment with glatiramer acetate (GA) compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the occurrence of the second clinical attack) during the double-blind period. The secondary objective is to assess, within the time frame of the up to 3-year double-blind, placebo-controlled study period, the effect of GA on clinical and Magnetic Resonance Imaging (MRI) parameters. The long-term objectives of the study (exploratory in nature) are to assess, within the time frame of 5 years, the neuroprotective effect of early versus delayed treatment with GA as reflected by clinical and MRI parameters measuring the accumulated irreversible brain tissue damage.

A pre-planned interim analysis was performed on all efficacy and safety data accumulated in the database up to October 14, 2007, i.e. when 81% of exposure to treatment in the double-blind, placebo-controlled period had been collected. Upon review of the interim analysis results, the Data Monitoring Committee (DMC) recommended that the double-blind portion of the study be stopped and that subjects be switched to the 2-year Open-label period, during which time they would have the option of receiving GA therapy. The sponsor (Teva) adopted the DMC recommendations and took the necessary action towards its implementation.


Options:
A: Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B (End of treatment (up to Week 6) for both Parts A and B)
B: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion (up to 3 years); Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period (up to 3 years)
C: Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 24 months); Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 36 months)
D: Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16 (16 Weeks); Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to Week 40)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Dosis of Vitamin D as Treatment for COPD.
Brief Summary: This project aims to explore the relationship between Vitamin D deficiency and COPD progression via a prospective randomized placebo-controlled study. For this purpose, study was powered to 120 patients hospitalized with an exacerbation of COPD randomly assigned to a monthly oral dose of Vitamin D versus placebo. Taking into account dropouts, 182 patients are randomized during the course of the study


Options:
A: rate of falls compared between treatment arms
B: median time to next exacerbation. (1 year)
C: C peptide
D: Change in Body Weight From Baseline to 12 Months (baseline, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Dosis of Vitamin D as Treatment for COPD.
Brief Summary: This project aims to explore the relationship between Vitamin D deficiency and COPD progression via a prospective randomized placebo-controlled study. For this purpose, study was powered to 120 patients hospitalized with an exacerbation of COPD randomly assigned to a monthly oral dose of Vitamin D versus placebo. Taking into account dropouts, 182 patients are randomized during the course of the study


Options:
A: serum Vitamin D (3 months)
B: median time to next exacerbation. (1 year)
C: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
D: Time to first upper respiratory tract infection (One year); Time to first severe asthma exacerbation (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study to Examine Sleep and Fatigue in Pediatric Brain Tumor Patients Hospitalized for High Dose Chemotherapy
Brief Summary: The purpose of this pilot study is to determine if patients randomized to a hospital sleep environment intervention would have improved sleep quality and reduced fatigue as compared to the patients not receiving the intervention (standard care).


Options:
A: Richmond Agitation-Sedation Scale (RASS) (3 days)
B: Acceptability and feasibility of the comfort intervention (Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge)
C: Average Daily Dexmedetomidine mcg/kg/Day (from time of first acupuncture/sham treatment till time of extubation); Average Daily Morphine Equivalents (mg/kg/Day) (from time of first acupuncture/sham treatment till time of extubation); Average Daily Midazolam Equivalents (mg/kg/Day) (from time of first acupuncture/sham treatment till time of extubation); Average Daily Sedation Score (from time of first acupuncture/sham treatment till time of extubation)
D: To assess sleep quality, fatigue and daytime activity during the 4 to 6-day hospitalization as being more positive for patients randomized to the sleep environment intervention months as compared to those randomized to the standard care months (Within 6 -10 months)

Answer: D