TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Child Uganda: Can Village Health Volunteers Trained in Integrated Community Case Management of Childhood Illness Improve Access to Care for Africa's Most Vulnerable Children?
Brief Summary: This study will assess how the current VHV (VHV=CHW, community health worker) scope can be expanded to include iCCM and if such group interventions can provide improved access to treatment for children.

In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving anti-malarials?


Options:
A: The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms (Until the estimated sample size is obtained or up to 2 yrs whichever comes first)
B: Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia (pre- (Dec 2010) post- (Dec 2012) intervention (2 years))
C: Appropriateness of treatment (36 months)
D: Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups (28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Child Uganda: Can Village Health Volunteers Trained in Integrated Community Case Management of Childhood Illness Improve Access to Care for Africa's Most Vulnerable Children?
Brief Summary: This study will assess how the current VHV (VHV=CHW, community health worker) scope can be expanded to include iCCM and if such group interventions can provide improved access to treatment for children.

In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving anti-malarials?


Options:
A: Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia (pre- (Dec 2010) post- (Dec 2012) intervention (2 years))
B: Number of Children Who Received Early and Appropriate Treatment for Pneumonia. (one year); Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) (one year)
C: Treatment failure (Day 8 of enrollemnt)
D: Institutional Birth Rate (3 years); Under-Two Mortality Rate (3 years); Post-Partum Contraceptive Prevalence Rate (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Child Uganda: Can Village Health Volunteers Trained in Integrated Community Case Management of Childhood Illness Improve Access to Care for Africa's Most Vulnerable Children?
Brief Summary: This study will assess how the current VHV (VHV=CHW, community health worker) scope can be expanded to include iCCM and if such group interventions can provide improved access to treatment for children.

In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving anti-malarials?


Options:
A: Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia (pre- (Dec 2010) post- (Dec 2012) intervention (2 years))
B: Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) (12 months post-randomisation (18 months for secondary outcome))
C: Number of death in children aged 6 to 59 months (12 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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures
Brief Summary: This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to \<4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.


Options:
A: Percent Change From Baseline in 28-day Seizure Frequency at Week 21. (6 weeks Baseline, 21 weeks through End of MP for 27 weeks)
B: Proportion of Participants With Response to Treatment (Baseline up to Week 16)
C: Partial onset seizure frequency (Type I) per week over the 7-week maintenance period (7-week maintenance period)
D: Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase (Day 1 up to Day 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making
Brief Summary: In partnership with patients, caregivers, advocacy groups and clinicians, the investigators plan to:

Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking Latinos and stakeholders.

Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:

2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and discuss wishes with surrogates and clinicians and complete ADs) measured by self-report, chart review, surrogate reports, and

2b. Direct observation.

2c. Improve self-efficacy and satisfaction with medical decision making.

2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and clinician-patient language concordance.

Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.


Options:
A: efficacy of PC-ACP
B: New Advance Care Planning Documentation in the Medical Record at 15 Months (15 months after study enrollment)
C: HbA1c (Change from baseline at 12 months)
D: Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT (Up to 1 week after the transplant education day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Home Fortification With Two Iron Formulations in Kenyan Children Protected Against Malaria by Artemisinin-based Combination Therapy: a Placebo-controlled Non-inferiority Trial
Brief Summary: This study will determine whether the haemoglobin response to daily home fortification for 30 days with 3mg iron as NaFeEDTA is non-inferior to 12.5 mg iron as encapsulated ferrous fumarate.


Options:
A: "negative nutritional outcome" of a child (6 months follow-up)
B: Change in length and length-for-age Z-score (36 weeks); Change in weight and weight-for-age Z-score (36 weeks); Incidence of diarrhea (36 weeks); Change in hemoglobin concentration (32 weeks); Change in micronutrient status (32 weeks); Innate and adaptive immune defense (32 weeks)
C: Change from baseline in the isotopic ratio of iron in blood at week 5 (Baseline and Week 5)
D: Hemoglobin concentration (End of the 30-day fortification period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Home Fortification With Two Iron Formulations in Kenyan Children Protected Against Malaria by Artemisinin-based Combination Therapy: a Placebo-controlled Non-inferiority Trial
Brief Summary: This study will determine whether the haemoglobin response to daily home fortification for 30 days with 3mg iron as NaFeEDTA is non-inferior to 12.5 mg iron as encapsulated ferrous fumarate.


Options:
A: Stunting-reduction in stunted children in intervention group (2 Years)
B: incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) (5 months)
C: Hemoglobin (Start of study (T=0), End of study (T=4months))
D: Hemoglobin concentration (End of the 30-day fortification period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
Brief Summary: The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.


Options:
A: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)
B: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
C: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)
D: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
Brief Summary: The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.


Options:
A: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)
B: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)
C: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
D: Recurrent deep venous thrombosis or venous thromboembolism (6 months); Occurrence of fatal or major bleeding (6 months); Mortality related to massive pulmonary embolism (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
Brief Summary: The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.


Options:
A: The primary safety outcome is the incidence of bleeding events occurring during the study period of 135 days (including follow-up). Major bleeding events and clinically relevant non-major bleeding events were defined according to accepted guidelines (135 days)
B: Recurrent venous thromboembolism (6 months)
C: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
D: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
Brief Summary: The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.


Options:
A: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
B: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)
C: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
D: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Importance of Electrical Stimulation as a Treatment for Urinary Incontinence in Patients Undergoing Prostatectomy to Exercise the Pelvic Floor Muscles (MAPs): Randomised Controlled Trial, Double Blind
Brief Summary: The use of electrical stimulation to reduce urinary incontinence in men undergoing prostatectomy exercises of the pelvic floor muscles (MAPs)


Options:
A: urinary incontinence (august/2013 to December/2013 (4 months))
B: Subjective report of urinary continence at 12 months; Incremental cost per quality-adjusted year
C: 24 hour Diaper test (weight in grams) at 6 weeks (Assessment at baseline and again after 6 weeks)
D: Amount of Urinary Leakage (Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment); Frequency of Daily Urinary Leakage (Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial
Brief Summary: The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.


Options:
A: Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair (Post-operatively (Day 1))
B: Postoperative nausea and vomiting (PONV) (24-32 hours postoperative)
C: The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40). (up to 20-24 hours after surgery)
D: Painscore during mobilization (2-24 hours after extubation time.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial
Brief Summary: The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.


Options:
A: Urinary Tract Infections (three weeks post-operative)
B: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)
C: The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40). (up to 20-24 hours after surgery)
D: To determine whether there is there an added benefit in using a MBP with regard to positioning of the large and small bowel for exposure of key anatomic structures during pelvic reconstructive surgical procedures. (Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to assess the efficacy of Gabapentin (Carbatin \& Neurontin) in patients with neuropathy pain.


Options:
A: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
B: Alteration of pain intensity after treatment (5 weeks)
C: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
D: Evaluation of pain intensity using the visual analog scale (VAS) (up to six weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Application of Appropriate Technology for Obesity Prevention and Control -- Study on Personalized Aerobic and Appropriate Exercise Technology
Brief Summary: The primary objective of this study is to assess the effectiveness of a school based physical activity programme on obesity and related health outcomes in young schoolchildren.


Options:
A: Change in self-esteem from baseline to 20-weeks (Change from baseline to 20-weeks); Change in grit from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Global Happiness from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Commitment to School from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Sense of Belonging at School from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Physical Activity from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Self-efficacy from baseline to 20-weeks (Change from baseline to 20-weeks)
B: MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-2 year intervention); MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-3 year intervention)
C: Change in body mass index (BMI) (Baseline, Month 3)
D: Changes in the composite ICH score of adolescents from baseline to year 2 and 4 (2 and 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Application of Appropriate Technology for Obesity Prevention and Control -- Study on Personalized Aerobic and Appropriate Exercise Technology
Brief Summary: The primary objective of this study is to assess the effectiveness of a school based physical activity programme on obesity and related health outcomes in young schoolchildren.


Options:
A: Our outcome measure was reduction of screen time (4 waves of data)
B: N/A
C: Change in body mass index (BMI) (Baseline, Month 3)
D: change in adiposity (baseline and 12 weeks); change in blood pressure (baseline and 12 weeks); change in metabolic function (baseline and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy
Brief Summary: The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.


Options:
A: Proportion of time with SpO2 within target range (16 hours); Proportion of Time with SpO2 within target range (16 hours)
B: Percent time in target range for oxygen saturation by pulse oximetry (24 hrs)
C: Cerebral tissue oxygen saturation (48 hours)
D: Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment (6 hours or 1 hour after cessation of oxygenation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Inspiratory Muscle Training (IMT) on Dyspnea in COPD During Pulmonary Rehabilitation: Randomized Controlled Trial
Brief Summary: Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone.


Options:
A: Measurement of the MIP
B: Dyspnea measure (21 - 4 days / +7 jours)
C: respiratory muscle strength measurements (baseline and 8 weeks)
D: Sustained Maximal Inspiratory Pressure (SMIP) (Change from baseline to 8 weeks and 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Multicenter, Randomized, Double-blind Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Psoriasis Area and Severity Index at 16 Weeks of Treatment Compared to Ustekinumab and to Assess Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR)
Brief Summary: This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis


Options:
A: Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43 (Through day 43); Part B: All Treatment Adverse Events Reported for Safety Evaluation (85 days); Part A: All Treatment Adverse Events Reported for Safety Evaluation (Cohort 1-4 43 days, Cohort 5-8 64 days)
B: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Week 12)
C: The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12) (Day 1 to Day 85); Number of Participants With Adverse Events (Day 1 to day 115)
D: Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 (Week 16)

Answer: D