TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
Brief Summary: The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.


Options:
A: 28-day mortality (Day 28)
B: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization (until hemodynamic stabilization (up to 48 hours))
C: Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis (6 months after injury); Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis (6 months after injury)
D: Mortality; Quality of Life

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
Brief Summary: The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.


Options:
A: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization (until hemodynamic stabilization (up to 48 hours))
B: Mortality; Quality of Life
C: Mortality (28 day); Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
D: Sublingual microcirculation (24 hour)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Management of Intracapsular Fractures of the Proximal Femur. A Prospective, Randomized Trial of Two Parallel Screws and Hemiarthroplasty
Brief Summary: An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, but there is no consensus about which procedure that gives best functional results.


Options:
A: Harris Hip Score at 4, 12 and 24 months; Barthel ADL Index at 4, 12 and 24 months; Eq-5d (Euroqol) at 4, 12 and 24 months
B: Harris hip score (2 years)
C: Number of Participants With Revision Surgery (Measured 2 years after original surgery)
D: visual analog scale (36 months); Harris hip score (36 months); Eq-5d index scores (36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures
Brief Summary: This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Options:
A: Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period (During the 7-week Treatment Period)
B: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (Baseline to 12-week Treatment Period)
C: Partial onset seizure frequency (Type I) per week over the 7-week maintenance period (7-week maintenance period)
D: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (From Baseline to 12-week Treatment Period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures
Brief Summary: This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Options:
A: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (Baseline to 12-week Treatment Period)
B: Partial onset seizure frequency (Type I) per week over the 7-week maintenance period (7-week maintenance period)
C: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (From Baseline to 12-week Treatment Period)
D: Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (12 week Treatment Period); 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (Baseline to 12 week Treatment Period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures
Brief Summary: This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Options:
A: Partial onset seizure frequency (Type I) per week over the 7-week maintenance period (7-week maintenance period)
B: Percent Change From Baseline in 28-day Seizure Frequency at Week 21. (6 weeks Baseline, 21 weeks through End of MP for 27 weeks)
C: Proportion of Participants With Response to Treatment (Baseline up to Week 16)
D: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (Baseline to 12-week Treatment Period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)
Brief Summary: The primary objective of this study is to compare, the number of patients with heartburn and regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole 20 mg or esomeprazole 40 mg.


Options:
A: Mean Change From Baseline to Month 12 for Hemoglobin Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Hematocrit Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Red Blood Cell Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Platelet Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for White Blood Cell Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Creatinine Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Calcium Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Total Bilirubin Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Serum Gastrin Levels (Baseline and Month 12); Mean Change From Baseline to Month 12 for Systolic Blood Pressure (Baseline and Month 12); Mean Change From Baseline to Month 12 for Diastolic Blood Pressure (Baseline and Month 12); Mean Change From Baseline to Month 12 for Pulse Rate (Baseline and Month 12); Changes From Baseline to Final Visit in Antrum Biopsy Results (Baseline and Final Visit (up to 12 months)); Changes From Baseline to Final Visit in Fundus Biopsy Results (Baseline and Final Visit (up to 12 months))
B: The Number of Patients With Complete Resolution of Heartburn by Week 4 (week 4 of treatment); The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4 (4 weeks); The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4 (4 weeks); The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4 (4 weeks)
C: Difference between the proportion of patients who discontinued on-demand esomeprazole treatment versus continuous esomeprazole treatment due to unsatisfactory treatment as determined by the investigator in consultation with the patient (6 months)
D: Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR. (Week 3 through Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
Brief Summary: This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.


Options:
A: Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12 (Baseline and Week 12); Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12 (Baseline and Week 12); Change From Baseline in the Vaginal pH at Week 12 (Baseline and Week 12); Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12 (Baseline and Week 12); Number of Participants With Adverse Events (From the first dose of study drug up to 14 days after the last dose; 14 weeks)
B: Clinical symptoms (after 12 months)
C: Pain thresholds and pain tolerance (Before and after eight weeks treatment)
D: Relief of vaginal symptoms (over 12 months of treatment); Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
Brief Summary: This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.


Options:
A: Pain thresholds and pain tolerance (Before and after eight weeks treatment)
B: Mean change from baseline in number of daily moderate to severe hot flushes.; Mean change from baseline in daily hot flush severity.; Mean change from baseline in vulvovaginal atrophy symptoms.
C: Relief of vaginal symptoms (following 12 weeks of treatment.)
D: Mean change in the symptom identified by the patient to be most bothersome (Randomization to Week 12); Mean change in vaginal pH (Randomization to Week 12); Mean change in maturation index (Randomization to Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized,Double-Blind , Placebo-Controlled Crossover Trial of Antivirals for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Co-infected Persons
Brief Summary: Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that HSV is an important co-factor in HIV transmission.

The trial's purpose is to assess the reduction in HIV systemic and mucosal replication associated with valacyclovir for suppression of HSV-2 reactivation.

This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.


Options:
A: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. (15 weeks)
B: To assess the impact of HSV-2 suppressive therapy on HIV shedding among co-infected women taking highly active antiretroviral therapy (HAART) or not needing HAART
C: Sequence-verified HIV-transmission from index to partner participant (March 2009)
D: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized,Double-Blind , Placebo-Controlled Crossover Trial of Antivirals for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Co-infected Persons
Brief Summary: Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that HSV is an important co-factor in HIV transmission.

The trial's purpose is to assess the reduction in HIV systemic and mucosal replication associated with valacyclovir for suppression of HSV-2 reactivation.

This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.


Options:
A: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)
B: Number of Participants With Clinical Adverse Experiences (Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)); Number of Participants With Laboratory Adverse Experiences (Day 1 to Week 208); Number of Participants With HIV-1 Infections (Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)); HIV-1 Viral Load in Infected Participants (Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants))
C: Difference of HIV-1 RNA and DNA shedding assessed by performing cervicovaginal lavage (CVL) HIV viral load, among groups; Difference of HSV-2 DNA shedding among groups
D: To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Falls, Fracture, and Osteoporosis Risk Control Evaluation (FORCE) Study: A Randomized Controlled Trial With Community Partnerships in Northern Ontario
Brief Summary: Falls and osteoporosis-related fractures cause substantial morbidity and mortality in the elderly, and are an increasingly important public health concern. A comprehensive multidisciplinary and integrated community-based approach is needed to identify and manage the population at highest risk of these complications. Unfortunately, current gaps in continuity of care and health intervention result in a sub-optimal state of health service for these individuals. The Falls, Fracture and Osteoporosis Risk Control and Evaluation (FORCE) Study is a two-year randomized controlled trial evaluated on the effect of coordinated community-based, multidisciplinary approach for fall and fracture prevention in Sault Ste. Marie.


Options:
A: Fall incidence (3 months)
B: Fall risk management, assessment and management of gate, strength and balance deficits, completion of medication review, including postural hypotension and psychotropic medications as well as the assessment and management of environmental risk factors.
C: fall incidence rate
D: rate of falls (12 months); proportion of fallers (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Falls, Fracture, and Osteoporosis Risk Control Evaluation (FORCE) Study: A Randomized Controlled Trial With Community Partnerships in Northern Ontario
Brief Summary: Falls and osteoporosis-related fractures cause substantial morbidity and mortality in the elderly, and are an increasingly important public health concern. A comprehensive multidisciplinary and integrated community-based approach is needed to identify and manage the population at highest risk of these complications. Unfortunately, current gaps in continuity of care and health intervention result in a sub-optimal state of health service for these individuals. The Falls, Fracture and Osteoporosis Risk Control and Evaluation (FORCE) Study is a two-year randomized controlled trial evaluated on the effect of coordinated community-based, multidisciplinary approach for fall and fracture prevention in Sault Ste. Marie.


Options:
A: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.
B: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)
C: Fall risk management, assessment and management of gate, strength and balance deficits, completion of medication review, including postural hypotension and psychotropic medications as well as the assessment and management of environmental risk factors.
D: Rates of BMD testing and/or osteoporosis pharmacotherapy in the year post-fracture using the population-based provincial administrative health data repository. (3 years (Phase 1 analysis at 1 year))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Domestic Violence Enhanced Home Visitation Program - DOVE
Brief Summary: DOVE Home Visit Program is a brochure based intervention delivery by public health nurses which aims to prevent and reduce intimate partner violence against pregnant and postpartum women and their infants.

The purpose of the study is to test the effect of home visits on reducing domestic violence and improving the lives of pregnant women and their children.


Options:
A: Severity of mental health symptoms (previous 4 weeks)
B: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
C: Severity of Violence Against Women (6 months); Women's Experience with Battering (6 months); Safety Behavior Checklist (6 months); Decisional Conflict Scale (6 months)
D: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Domestic Violence Enhanced Home Visitation Program - DOVE
Brief Summary: DOVE Home Visit Program is a brochure based intervention delivery by public health nurses which aims to prevent and reduce intimate partner violence against pregnant and postpartum women and their infants.

The purpose of the study is to test the effect of home visits on reducing domestic violence and improving the lives of pregnant women and their children.


Options:
A: Reduced child abuse and neglect (2002 - 2005)
B: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
C: Intimate partner violence (One year)
D: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Domestic Violence Enhanced Home Visitation Program - DOVE
Brief Summary: DOVE Home Visit Program is a brochure based intervention delivery by public health nurses which aims to prevent and reduce intimate partner violence against pregnant and postpartum women and their infants.

The purpose of the study is to test the effect of home visits on reducing domestic violence and improving the lives of pregnant women and their children.


Options:
A: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
B: Change in Intimate Partner Violence Victimization from Baseline (12 months)
C: Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months (Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
D: Change in partner violence victimization (summary score) (baseline to 12 months); Change in reproductive coercion (summary score) (baseline to12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Domestic Violence Enhanced Home Visitation Program - DOVE
Brief Summary: DOVE Home Visit Program is a brochure based intervention delivery by public health nurses which aims to prevent and reduce intimate partner violence against pregnant and postpartum women and their infants.

The purpose of the study is to test the effect of home visits on reducing domestic violence and improving the lives of pregnant women and their children.


Options:
A: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
B: Incident Gender-Based Violence (GBV) (3 months postpartum); Incident GBV (6 months postpartum)
C: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
D: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence

Answer: A