TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Newborn Antiseptic Washing and Neonatal Mortality-Nepal
Brief Summary: Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver babies at home without a skilled birth attendant.

The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with a dilute antiseptic solution soon after birth can reduce mortality in the first 4 weeks of life and 2) to evaluate whether cleaning the umbilical cord and stump with either soap and water or an antiseptic solution for the first few days of life can reduce umbilical cord infections.


Options:
A: N/A
B: Incidence of Neonatal Omphalitis (By the end of the styudy); Rate of Neonatal Mortality (By the end of the Study)
C: neonatal mortality; umbilical cord infection
D: neonatal mortality (3 Month intervals); omphalitis among live born infants. (3 Month intervals)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Newborn Antiseptic Washing and Neonatal Mortality-Nepal
Brief Summary: Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver babies at home without a skilled birth attendant.

The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with a dilute antiseptic solution soon after birth can reduce mortality in the first 4 weeks of life and 2) to evaluate whether cleaning the umbilical cord and stump with either soap and water or an antiseptic solution for the first few days of life can reduce umbilical cord infections.


Options:
A: neonatal mortality; umbilical cord infection
B: Incidence of Neonatal Omphalitis (By the end of the styudy); Rate of Neonatal Mortality (By the end of the Study)
C: neonatal mortality (3 Month intervals); omphalitis among live born infants. (3 Month intervals)
D: Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life; Rate of vertical transmission of colonization with group B streptococcus (GBS)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1
Brief Summary: The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Lenalidomide in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1.


Options:
A: Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment (Day 0, Week 12)
B: Usual pain intensity in lower extremity(ies) (Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
C: Difference between treatment groups in responder rates. (3 Months)
D: Duration Adjusted Average Change (DAAC) of Mean Pain Score (Baseline, Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and Sorafenib Versus Carboplatin, Paclitaxel and Placebo in Patients With Unresectable Locally Advanced or Stage IV Melanoma
Brief Summary: This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel in treating melanoma.


Options:
A: Overall Survival (Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.)
B: Progression Free Survival (PFS) (From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)); Overall Survival (OS) (From randomization to date of death (Assessed up to September 2016, approximately 39 months)); Rate of Overall Survival (6, 12, and 24 months); Rate of Progression-Free Survival (6, 12, and 24 months)
C: Response to Neoadjuvant Therapy by Therapy Arms: Clinical Response Rates (CR + PR + SD) (Evaluated after a total of 8 weeks of therapy before definitive surgery.); Response to Neoadjuvant Therapy: Overall Clinical Responses (Evaluated after a total of 8 weeks of therapy before definitive surgery.)
D: Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria (From Day 1, first dose to end of Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA
Brief Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens.

PURPOSE: This randomized phase III trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer.


Options:
A: Time to clinical progression (Throughout study period); Overall patient survival (Throughout study period)
B: Death from any cause at 8 years
C: To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone. (Years)
D: Time to clinical progression (Throughout study period); Tolerability in terms of adverse events and laboratory parameters (Throughout study period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tai Chi Mind-Body Therapy for Chronic Heart Failure
Brief Summary: The purpose of this study is to determine the effects of a tai chi exercise program on functional capacity and health-related quality of life in patients with chronic heart failure (HF). This study will also examine the way tai chi influences mental, physical, and social functioning.


Options:
A: Peak oxygen uptake
B: HF-specific quality of life (baseline, midpoint, endpoint, 6mo); functional capacity (baseline and endpoint); Walking Test (baseline, midpoint, endpoint)
C: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
D: Peak exercise capacity (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tai Chi Mind-Body Therapy for Chronic Heart Failure
Brief Summary: The purpose of this study is to determine the effects of a tai chi exercise program on functional capacity and health-related quality of life in patients with chronic heart failure (HF). This study will also examine the way tai chi influences mental, physical, and social functioning.


Options:
A: change in 6 minute walk test (3 months)
B: HF-specific quality of life (baseline, midpoint, endpoint, 6mo); functional capacity (baseline and endpoint); Walking Test (baseline, midpoint, endpoint)
C: Improvement tolerance capacity (4 months and 6 months)
D: 6 Minute Walk Test (up to 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of School Based Supervised Asthma Therapy
Brief Summary: 1. Develop a simple school-based intervention using school-based supervised asthma therapy to increase adherence to asthma medication.
2. Implement a school-based internet monitoring system within both the school-based supervised asthma therapy and parent supervised asthma therapy groups to record asthma symptoms, peak flow meter readings, school absences, and usage of rescue medications at school.
3. Randomly assign 250 children from inner-city school systems to either school-based supervised asthma therapy or parental supervised asthma therapy.
4. Compare children assigned to school-based supervised asthma therapy with children assigned to parent supervised asthma therapy, in regards to time-averaged proportion having at least one exacerbation per month, rescue medication use, peak flow meter readings, asthma symptoms, school absences, and asthma self-management knowledge.


Options:
A: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))
B: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
C: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))
D: Asthma exacerbations (Measured at 15 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
Brief Summary: The purpose of this study is to determine the effects of low-dose aspirin for the primary prevention of vascular events in patients with type 2 diabetes in Japan.


Options:
A: Glomerular Filtration Rate; Adverse Events
B: Cardiovascular events (five years (median)); Cerebral vascular events (five years (median)); Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment (five years (median))
C: N/A
D: The differences of platelet aggregation according to the anti-platelet therapy. (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Brief Summary: The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.


Options:
A: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)
B: Percentage of Patients Relapsing by Week 16 (From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment)
C: Change in Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline and Day 42)
D: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (Baseline and Week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Brief Summary: The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.


Options:
A: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (Baseline and Week 4)
B: N/A
C: Suicidal Ideation Questionnaire - JR (SIQ-JR) (Baseline, 6 weeks, 12 weels, 24 weeks); Beck Depression Inventory - II (BDI-II) (Baseline, 6 weeks, 12 weeks, 24 weeks); Scale for Suicidal Ideation (SSI) (baseline, 6 weeks, 12 weeks, 24 weeks)
D: evaluate the efficacy of different preventive programs. (2012)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Brief Summary: The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.


Options:
A: Scores in the Young Mania Rating Scale (BD); Scores in the SNAP-IV (ADHD); Weight
B: Scores in the SNAP-IV (ADHD); Scores in the Young Mania Rating Scale (BD); Weight
C: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (Baseline and Week 4)
D: Change from baseline to endpoint in a mania rating scale

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Glucosamine Sulfate Versus a Pure Analgesic (Acetaminophen/Paracetamol) and Placebo in Patients Suffering From Osteoarthritis of the Knee
Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of glucosamine sulfate versus placebo on the symptoms of knee osteoarthritis after 6 months of treatment, using acetaminophen as a reference symptomatic medication.


Options:
A: N/A
B: Functional Capacity (14 weeks)
C: Lequesne Index
D: Change in Global Spontaneous Pain Intensity of Target Hand (6 months); Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand (6 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Glucosamine Sulfate Versus a Pure Analgesic (Acetaminophen/Paracetamol) and Placebo in Patients Suffering From Osteoarthritis of the Knee
Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of glucosamine sulfate versus placebo on the symptoms of knee osteoarthritis after 6 months of treatment, using acetaminophen as a reference symptomatic medication.


Options:
A: Lequesne Index
B: Change in 100mm Pain VAS (baseline throgh week 8)
C: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
D: Average change from baseline through Week 12 for WOMAC pain subscale score. Average change from baseline through Week 12 for WOMAC physical function subscale score. Subject's average global assessment of response to therapy through Week 12.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine if folic acid supplementation can slow down atherosclerotic progression, age-related cognitive decline and age-related hearing loss.


Options:
A: Cardiovascular disease; Cancer
B: Depression (Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.)
C: Change in mean carotid intima-media thickness; Change in maximum carotid intima-media thickness
D: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine if folic acid supplementation can slow down atherosclerotic progression, age-related cognitive decline and age-related hearing loss.


Options:
A: Change in mean carotid intima-media thickness; Change in maximum carotid intima-media thickness
B: Change in Clinical Dementia Rating Scale (CDR) (Change from baseline in CDR at month 9, 18, 27)
C: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
D: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: STALWART: A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 With and Without Concomitant Antiretroviral Therapy in Patients With HIV-1 Infection and CD4+ Cell Counts of 300 Cells/mm3 or More
Brief Summary: The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy.

Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to patients with early HIV infection, will produce no change in HIV viral load and increases in CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.


Options:
A: Mean Change in CD4+ T Lymphocyte Count (Week 32)
B: New or Recurrent HIV Disease Progression Event Including Death (from randomization through study end - median of 7.6 years follow-up)
C: New or Recurrent Disease Progression Events, as Defined, or Death. (From randomization to date last known to be alive or November 15, 2008, whichever is earlier)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
Brief Summary: The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).


Options:
A: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
B: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
C: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
D: Sudden cardiac death (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
Brief Summary: The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).


Options:
A: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
B: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. (Total follow-up time of up to approximately 6 years.)
C: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
D: Atrial tachycardia and atrial fibrillation burden (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
Brief Summary: The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).


Options:
A: time to clinical relapse (52 weeks)
B: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)
C: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
D: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
Brief Summary: The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).


Options:
A: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
B: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (baseline and 12 weeks)
C: Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)
D: Differences in mean systolic blood pressure in the two diet/sport arms (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
Brief Summary: The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).


Options:
A: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)
B: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
C: N/A
D: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
Brief Summary: The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).


Options:
A: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
B: Number of Participants Who Developed Postoperative Atrial Fibrillation (14 days)
C: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
D: Survival free of atrial fibrillation (12 months)

Answer: C