TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits
Brief Summary: The purpose of this study is to determine whether the Intimate Partner Violence (IPV) intervention in the context of Nurse-Family Partnership (NFP) program improves women's quality of life and reduces violence relative to the NFP alone using a cluster randomized controlled trial. Our hypothesis is that an IPV intervention can be designed that is acceptable to participants in the NFP, feasible to implement, and that this intervention will improve quality of life for women and reduce exposure to violence.


Options:
A: 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)
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: Discussion of family psychosocial problem; Referral of family psychosocial problem; Contacting community resources
D: Reduced child abuse and neglect (2002 - 2005)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial
Brief Summary: An increasing number of patients survive critical illness and intensive care, but describe having impaired physical function several years after discharge as a consequence of extensive loss of muscle mass. Reasons for loss of muscle mass and physical function are multiple, but insufficient nutrition is likely to contribute.

This randomised trial will investigate the effect of an optimised nutrition therapy during intensive care, on short term clinical outcome and physical quality of life. We hypothesise, that early nutritional therapy, directed towards patient-specific goals for energy and protein requirements, will improve both short- and long-term outcomes.


Options:
A: Physical function (6 months after randomisation)
B: During the postoperative period, all patients were observed for both surgical and non-surgical complications (52 months)
C: Documented Infection Rate (20 days)
D: Length of stay in ICU and length of stay in the hospital. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Appalachian Cervical Cancer Prevention Project
Brief Summary: The purpose of this study is to determine whether a faith-placed lay health advisor intervention is effective in increasing use of Pap smears among middle-aged and older Appalachian women.


Options:
A: Proportion of participants self-reporting receipt of Pap test (One month post-intervention)
B: 1. ADEs; 2. duration of ameliorable medication side effects; 3. health goal adherence rates; 4. diabetes outcomes; 5. familial risk factor documentation rates; 6. user satisfaction surveys; 7. user metrics
C: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)
D: Patient Satisfaction in the 2 Interventions (within 6 months of PAP); CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy (within 6 months of PAP)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this study is to further characterize the dose response of GSK573719 at doses of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be included to further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily via the Handihaler will be included as an active control. A placebo treatment will be included in order to evaluate absolute treatment effect of the different doses of GSK573719.


Options:
A: adverse events, cardiac and ECG parameters, vital signs, lung function and clinical laboratory safety assessments (From dosing to 24hr post-dose)
B: Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) (From the start of study drug up to 52 weeks)
C: Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1 (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period (Baseline and Day 8 of each treatment period (up to Study Day 50))
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism Targeting Memory and Motor Planning
Brief Summary: This study will attempt to study the effect of memantine, on memory, and motor praxis/expressive language skills in children with autism.

The investigators will recruit children ages 6-12 years who are verbal and meet criteria for Autism Spectrum Disorder. The children will be assessed for memory function, expressive language output and motor skills/praxis. They will then be randomized to memantine or placebo for 6 months. The effects of this medication and its safety in this population will be studied over the 6 month period.


Options:
A: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)
B: Clinical Global Impression-Improvement (Change from baseline to end of week 12); Aberrant Behavior Checklist- Irritability (Change between baseline and end of each phase)
C: Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)); Expressive Vocabulary Test (EVT) (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial))
D: Aberrant Behavior Checklist Hyperactivity Subscale (Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism Targeting Memory and Motor Planning
Brief Summary: This study will attempt to study the effect of memantine, on memory, and motor praxis/expressive language skills in children with autism.

The investigators will recruit children ages 6-12 years who are verbal and meet criteria for Autism Spectrum Disorder. The children will be assessed for memory function, expressive language output and motor skills/praxis. They will then be randomized to memantine or placebo for 6 months. The effects of this medication and its safety in this population will be studied over the 6 month period.


Options:
A: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
B: Clinical Global Impression-Scale(CGI-S) (12 weeks)
C: Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)); Expressive Vocabulary Test (EVT) (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial))
D: Patients With Any Treatment-emergent Adverse Event (Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared With Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease
Brief Summary: RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.

PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.


Options:
A: Cognitive Deterioration Free Survival Post-radiation in Patients Who Received SRS Compared to Patients Who Received WBRT (from baseline up to 5 years post radiation); Overall Survival (from baseline up to 5 years post radiation)
B: Time to local recurrence (6 months)
C: Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
D: Overall survival and Quality of life (Until death or study completion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Novel Human Milk Fortifier in Preterm Infants
Brief Summary: The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.


Options:
A: Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day. (21 days)
B: Weight gain (29 days)
C: Weight gain (From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA))
D: Weight gain due to fat mass (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Novel Human Milk Fortifier in Preterm Infants
Brief Summary: The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.


Options:
A: Weight gain due to fat mass (4 weeks)
B: Weight gain (29 days)
C: growth (from inclusion at postmentrual age <32 weeks until 36 weeks)
D: Caloric content of human milk (Daily until 36 weeks corrected gestational age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.
Brief Summary: The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.


Options:
A: Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate (At 12 Weeks)
B: Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14); Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24 (Baseline (Week 0) and Week 24)
C: Percentage of Participants With American College of Rheumatology-ACR20 Response (Baseline, Week 24); Change From Baseline in Modified Total Sharp-Genant Score at Week 52 (Baseline, Week 52); Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52 (Baseline to Week 52); Change From Baseline in the Modified Total Sharp-Genant Score at Week 104 (Baseline, Week 104); Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104 (Baseline to Week 104)
D: Change From Baseline in the Volume Transfer Rate From the Blood Plasma to the Enhancing Synovium (Ktrans) (Baseline and week 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes
Brief Summary: The purpose of this study is to help low income patients achieve and maintain better self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood pressure monitoring system and nurse case management. Patients must be served at a Federally Qualified Health Center (FQHC) in coastal South Carolina.


Options:
A: The primary endpoint is the A1c level or the change in A1c level. (6 months)
B: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
C: Change in HgbA1c (Glycemic control) (baseline, six month, one year, two years and three years)
D: Hemoglobin A1c (HbA1c) at 6 Months Post Randomization (6 months post randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes
Brief Summary: The purpose of this study is to help low income patients achieve and maintain better self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood pressure monitoring system and nurse case management. Patients must be served at a Federally Qualified Health Center (FQHC) in coastal South Carolina.


Options:
A: Home Monitoring Effectiveness (12 months); Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. (12 months)
B: The rate of cardiac or device related clinic visits (16 months)
C: Hemoglobin A1c (HbA1c) at 6 Months Post Randomization (6 months post randomization)
D: Brain Natriuretic Peptide values (Baseline, 6 months); Self-care practices measured through Self-Care of Heart Failure Index scores and interviews (baseline, 6 months); Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews (baseline, 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer in the County of Valles Occidental: CRICERVA Clinical Trial.
Brief Summary: The aim of this study was to compare the effectiveness and the costs of three types of population interventions to increase the number of female participants in the screening programmes for cancer of the cervix carried out by Primary Care in four Basic Health Care Areas.


Options:
A: Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out. (90 days)
B: performing a HPV test within 3 months since the recall letter (up to december 2012 (up to 3 months))
C: The proportion of control and intervention subjects who are current on EACH individual indicated preventive service (Annual for three years); The proportion of control and intervention subjects who are current on ALL indicated preventive services (Annual for three years); The mean score for intervention and control subjects for quality of clinician communication (CAPHS-CGS questions 14-20); and frequency with which patients report sharing medical decisions (CAHPS questions SD 1-3) (Annual for three years)
D: Clinical effectiveness measures (Third year); Costs measures (Third year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Maximum Alveolar Recruitment Maneuver Plus Titrated PEEP Versus ARDSNet Strategy for ARDS
Brief Summary: Acute respiratory distress syndrome (ARDS) is a common scenario in intensive care unit. Discussions about it is exponentially growing up due its high mortality rates all over the world and low quality of life among survivors. Mechanical ventilation is recognized to play an important role in treatment of patients with ARDS. However, mechanical ventilation itself has the potential to produce or worsen alveolar injury if inadequate strategies are chosen. Several studies compared different mechanical ventilation strategies in ARDS but the results remain uncertain regarding their influence on survival in patients with ARDS. Thus, this is a multicentric randomized controlled trial, with allocation concealment and intention to treat analysis to investigate if maximum alveolar recruitment maneuver in association to Positive end-expiratory pressure (PEEP) titrated by static compliance of respiratory system (ART strategy) is able to increase 28 days survival in patients with moderate to severe ARDS compared to conventional strategy proposed by the ARDS Clinical Network (ARDSNet strategy). Patients considered to this trial are those in mechanical ventilation with diagnosis of moderate to severe ARDS less than 72hours. Patients included will be randomized to receive ART strategy or ARDSNet strategy and will be followed until hospital discharge, 28 days and 6 months.


Options:
A: Number of Ventilator Free Days at Day 28 Post Randomisation (28 days post randomisation)
B: Mortality rate (at day 90)
C: 28-day mortality from all causes (28 days)
D: Survival in 28 days (28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of an One-year Physical Exercise Intervention on Prognosis, Side-effects and Complications After Allogeneic Stem Cell Transplantation
Brief Summary: The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an one-year physical exercise intervention on prognosis, side-effects and complications after allogeneic stem cell transplantation.

The exercise intervention includes both, resistance and endurance training. Patients assigned to the control group perform a relaxation program (progressive muscle relaxation - Jacobsen) and have the same frequency of social contact.


Options:
A: Overall survival (two years)
B: Possible (neuro)physiological determinants of postcancer fatigue (The measurements will be performed at baseline and comparable measurements will be performed 6 months later (after 6 months cognitive behavior therapy or 6 months waiting list condition))
C: Six Minute Walk Distance 6MWD (Change from baseline in 6MWD at 12 weeks)
D: Change from baseline in Exercise Levels (Baseline and within 7 days of completing the 12-week intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
Brief Summary: The aim of the study was to assess the efficacy of Sanofi Pasteur's CYD dengue vaccine in preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of Latin America.

Primary Objective:

To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children and adolescents aged 9 to 16 years at the time of inclusion.

Secondary Objectives:

* To describe the efficacy of CYD dengue vaccine in preventing symptomatic VCD cases after the third dose to the end of the Active Phase, after at least 1 dose, and after 2 doses.
* To describe the occurrence of hospitalized VCD cases and the occurrence of severe (clinically severe or as per World Health Organization (WHO) criteria) VCD cases, throughout the Surveillance Expansion Period (SEP) and throughout the trial (from Day 0 until the end of the study).
* To describe the antibody response to each dengue serotype after Dose 2, after Dose 3, and 1 and 5 years after Dose 3.
* To describe the occurrence of serious adverse events (SAEs), including SAEs of special interest in all participants throughout the trial period.


Options:
A: Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection With Either CYD Dengue Vaccine or a Placebo (28 days and up to 13 months post-injection 3)
B: Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo (28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months))
C: Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection (Inj.) With Either CYD Dengue Vaccine or a Placebo (28 days and up to 13 months post-dose 3)
D: Odds ratio of Wolbachia exposure distribution among laboratory-confirmed reported dengue cases compared to test-negative controls (Up to 3 years); Laboratory-confirmed reported dengue case counts normalized by population size in intervention versus non-intervention clusters (Up to 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Relapse Following Involuntary Smoking Abstinence
Brief Summary: The prevalence of tobacco use in the military is too high. This study is designed to take advantage of the 8.5 weeks of forced tobacco cessation during Basic Military Training and develop effective interventions to prevent tobacco relapse.

Hypotheses or Research Questions:

* Are there differences in the rate of relapse between three groups participating in a tobacco abstinence maintenance intervention?
* Do the tobacco abstinence maintenance interventions delay relapse?


Options:
A: Duration of smoke-free status (8 weeks postpartum); Duration of breastfeeding (8 weeks postpartum)
B: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)
C: Smoking cessation maintenance (12 month follow-up)
D: Continuous abstinence Weeks 13 -24.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Relapse Following Involuntary Smoking Abstinence
Brief Summary: The prevalence of tobacco use in the military is too high. This study is designed to take advantage of the 8.5 weeks of forced tobacco cessation during Basic Military Training and develop effective interventions to prevent tobacco relapse.

Hypotheses or Research Questions:

* Are there differences in the rate of relapse between three groups participating in a tobacco abstinence maintenance intervention?
* Do the tobacco abstinence maintenance interventions delay relapse?


Options:
A: Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine (6 months)
B: Smoking cessation maintenance (12 month follow-up)
C: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)
D: Continuous abstinence Weeks 13 -24.

Answer: B