TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Finnish Diabetes Prevention Study: A Follow-up Study on the Effect of a Dietary and Exercise Intervention in the Prevention of Diabetes and Its Vascular Complications
Brief Summary: The aim of this study is to clarify whether lifestyle intervention provided to people with high type 2 diabetes risk will lower the cumulative incidence of diabetes. Furthermore, the aim is to study the effect of lifestyle intervention on cardiovascular risk.


Options:
A: Diabetes incidence (During the intervention period + after the intervention has been stopped)
B: Fasting Glucose (Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization)
C: Body Mass Index (Baseline, 3-, 6- and 15- month follow-up)
D: Incident diabetes mellitus (Up to 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
Brief Summary: This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents


Options:
A: Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse (1 month post MenACWY vaccination); Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL (1 month post Tdap vaccination); Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN) (1 month post Tdap vaccination)
B: Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 (Up to year 8); Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 (Up to year 9); Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18 (Up to year 7)
C: Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points (Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48); Frequency of Persistent HPV 16/18/6/11 Infection. (From date of marriage through to 7 years of follow-up); Frequency of HPV 16/18-associated Precancerous Lesions and Cancer. (Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen)
D: Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) (4 weeks post-vaccination 3 (Month 7)); Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) (4 weeks post-vaccination 3 (Month 7)); Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) (4 weeks post-vaccination 3 (Month 7)); Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs) (Up to 5 days after any vaccination); Base Study: Percentage of Participants With Systemic AEs (Up to 15 days after any vaccination); Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) (Up to 5 days after any vaccination); Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine (Up to ~Month 126); Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine (Up to ~Month 126)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-Blind, Weight-Based, Fixed-Dose, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of 3 weight-based, fixed-dose groups of paliperidone extended release (ER) compared with placebo in adolescent patients between 12 to 17 years of age, who are diagnosed with schizophrenia. Paliperidone ER is an atypical antipsychotic agent approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in adults. Patients may be voluntary inpatients or outpatients at the time of the screening visit, but should have returned to their usual living situation by Day 21 of the double-blind treatment phase. The study duration is approximately 10 weeks. Patients who have completed this study or who were discontinued from this study due to lack of efficacy but have completed at least 21 days of double-blind treatment and are expected to benefit from paliperidone treatment, may enter an optional open-label safety study.


Options:
A: Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C. (From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks)
B: Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study. (6 weeks)
C: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
D: Number of Participants With Drug-related Adverse Events (From first drug administration until 30 days after last drug administration, up to 44 days.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center Trial to Study Acute Liver Failure in Adults
Brief Summary: The purpose of this study is to collect clinical and epidemiological data as well as serum, plasma, urine, tissue and DNA samples on individuals who have acute liver failure and on individuals who have acute liver injury, a less severe group of patients who have coagulopathy but do not reach the threshold of encephalopathy.


Options:
A: The primary endpoint is the proportion of patients who do not vomit or retch within 2 hours of initiation of acetylcysteine treatment and no use of rescue medication. Retching will be defined as a vomit not producing any liquid. (2 hours post start of treatment)
B: serum a-GST relative to baseline
C: Overall Survival (1 Year)
D: Patient survival at six months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols
Brief Summary: The purpose of this study is to compare how effective different ways of mouth cleaning are for patients in a neuroscience intensive care unit with a breathing tube in their mouth.


Options:
A: Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours (Every 48 hours until discharge)
B: Development of Ventilator Acquired Pneumonia (During the period of intubation)
C: Ventilator associated pneumonia (48 hours after tracheal intubation)
D: Nosocomial Infection

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols
Brief Summary: The purpose of this study is to compare how effective different ways of mouth cleaning are for patients in a neuroscience intensive care unit with a breathing tube in their mouth.


Options:
A: Development of VAP (Clinical Pulmonary Infection Score) (Baseline up to 5 days)
B: Prevention of ventilator-associated pneumonia (60 days)
C: Development of Ventilator Acquired Pneumonia (During the period of intubation)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
Brief Summary: The aim of the present study is to evaluate the (cost) effectiveness of a new health care system in which an individualised multidisciplinary assessment is given to patients with Parkinson's Disease(PD)in combination with treatment by a dedicated team of specifically trained health professionals, compared to usual care. Overall, we anticipate to gain more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD.


Options:
A: UNIFIED PARKINSON'S DISEASE RATING SCALE (08/2011 (up to 2 years))
B: Limits of stability test (Change from Baseline at 8 weeks); One-leg stance test (Change from Baseline at 8 weeks)
C: Parkinson's Disease Quality of Life Questionnaire (PDQL) (8 months); AMC Linear Disability Score (ALDS) (8 months)
D: Falls rate (6 months post intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial for the Treatment of Postnatal Depression
Brief Summary: A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development.


Options:
A: N/A
B: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs
C: EPDS (3 and 6 months)
D: Quick Inventory of Depressive Symptomatology - Clinician Administered (QIDS-C) (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial for the Treatment of Postnatal Depression
Brief Summary: A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development.


Options:
A: Hamilton Depression Rating Scale (HAM-D) (Measured at baseline; post-treatment; and Months 3 and 6 of follow-up)
B: Depressive symptoms, social functioning, and health (Measured at Months 3, 6, and 12 postpartum); Preferences for depression treatment (Measured at baseline and Month 12)
C: depression (12 weeks)
D: EPDS (3 and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial for the Treatment of Postnatal Depression
Brief Summary: A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development.


Options:
A: Remission (i.e. recovery from depression) (6 months post child birth)
B: EPDS (3 and 6 months)
C: General psychological distress - General Health Questionnaire (20-weeks after baseline)
D: Depression (6 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lufwanyama Neonatal Survival Project
Brief Summary: We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.


Options:
A: Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate (7 days post delivery)
B: Neonatal mortality rate
C: mortality (day 28)
D: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lufwanyama Neonatal Survival Project
Brief Summary: We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.


Options:
A: Perinatal Mortality (Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.)
B: Neonatal mortality (7 days)
C: mortality (day 28)
D: Perinatal mortality (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lufwanyama Neonatal Survival Project
Brief Summary: We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.


Options:
A: Post day 1 Neonatal mortality (birth to 28 days of age) in the communities receiving the intervention(cohort of infants born to women identified through pregnancy surveillance) (Over 30 Months); Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance (Over 30 Months); Post day 1 neonatal mortality (1 to 28 days of age) in the population of newborns who are more likely to have greater impact from the intervention i.e. those born at home and available in the study area within 7 days of birth (30 months); Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention (30 months); Infant mortality (birth to 365 days) in the communities receiving the intervention. (30 months)
B: mortality (day 28)
C: Difference in the under-five child mortality rate between the two study arms (36 months)
D: Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for presumed pneumonia. (March 2013 - November 2014 (8 months)); Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for diarrhea (March 2013 - November 2014 (8 months)); Percentage of change in number of children under five in intervention area who receive Integrated Community Case Management Treatment from a Community Health Worker for fever. (March 2013 - November 2014 (8 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lufwanyama Neonatal Survival Project
Brief Summary: We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.


Options:
A: mortality (day 28)
B: Neonatal mortality (7 days)
C: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
D: Neonatal mortality rate

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lufwanyama Neonatal Survival Project
Brief Summary: We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.


Options:
A: All cause Neonatal Mortality (2 years)
B: Post day 1 Neonatal mortality (birth to 28 days of age) in the communities receiving the intervention(cohort of infants born to women identified through pregnancy surveillance) (Over 30 Months); Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance (Over 30 Months); Post day 1 neonatal mortality (1 to 28 days of age) in the population of newborns who are more likely to have greater impact from the intervention i.e. those born at home and available in the study area within 7 days of birth (30 months); Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention (30 months); Infant mortality (birth to 365 days) in the communities receiving the intervention. (30 months)
C: mortality (day 28)
D: Treatment failure (Seven days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.


Options:
A: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26)
B: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) (Baseline to Week 24)
C: HbA1c Change From Baseline at Week 52 (Baseline and week 52); HbA1c Change From Baseline at Week 104 (Baseline and week 104)
D: Change in baseline HbA1c after 52 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.


Options:
A: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
B: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (week 0, week 52); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 (week 0, week 104); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 (week 0, week 156)
C: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26)
D: HbA1c (after 26 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.


Options:
A: HbA1c (after 26 weeks of treatment)
B: Mean Change From Baseline in Body Weight at Week 20 (Week 0, week 20)
C: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26)
D: Change in HbA1c From Baseline to Week 26 (Day 1, Week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Major Depressive Disorder or Dysthymic Disorder
Brief Summary: The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder.


Options:
A: sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness (during treatment while at altitude)
B: Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline) (Baseline and 12 weeks (or last observation after baseline)); Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline) (12 weeks (or last observation after baseline))
C: Polysomnography parameters: respiratory parameters, sleep structure (baseline, 28 days, 15 days, 28 days)
D: Incidence of hypertension; Incidence of cardiovascular events

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravenous Infusion of High Dose Omeprazole Versus Regular Dose Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers
Brief Summary: Bleeding peptic ulcers are one of the major causes of morbidity and mortality for hospital emergency admissions.The initial treatment is endoscopic therapy followed by intravenous omeprazole. However the optimal dosage of omeprazole is not known. We conducted this study to find out the optimal dosage in such clinical scenario.


Options:
A: Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy (one year)
B: Intragastric pH > 6 (24 hours)
C: Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers (30 days after endoscopic therapy)
D: Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo (Within 72 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer
Brief Summary: RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients with lung cancer. It is not yet known whether dalteparin is effective in preventing blood clots in patients with lung cancer.

PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.


Options:
A: Thromboembolic events (during study treatment)
B: Number of Participants With Venous Thromboembolic Events (VTE) (16 weeks of treatment)
C: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)
D: Overall survival

Answer: D