TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis
Brief Summary: The purpose of this study is to evaluate the therapeutic response to fluconazole in patients with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.


Options:
A: Complete Clinical Response (Until 6 months posttreatment); Failure (Until 3 months posttreatment)
B: Cure rate or complete cicatrization of the ulcer. (6 months)
C: The primary outcome measure will be the proportion of "Therapeutic Failures" diagnosed during the final (week 26) visit or before, according to defined clinical criteria. (26 weeks (6 months)); Evidence of clinical or laboratory toxicity during the treatment period. (During the treatment period (20 or 28 days))
D: Final Clinical Cure for Index Lesions (Initial clinical cure by day 63 and no relapse by day 168)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Improvements With Minute Ventilation-targeted ASV Therapy in Heart Failure (CAT-HF)
Brief Summary: The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF. The study will also assess changes in functional parameters, biomarkers, quality of life (QOL), and sleep.


Options:
A: Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period (3 months)
B: All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation (time to first event, assessed for up to 70 weeks)
C: Left ventricular ejection fraction confirmed by echocardiography (three months)
D: Global Rank Endpoint (Baseline, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Improvements With Minute Ventilation-targeted ASV Therapy in Heart Failure (CAT-HF)
Brief Summary: The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF. The study will also assess changes in functional parameters, biomarkers, quality of life (QOL), and sleep.


Options:
A: improvement of isovolumetric relaxation time (30 minutes)
B: Left ventricular ejection fraction confirmed by echocardiography (three months)
C: All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation (time to first event, assessed for up to 70 weeks)
D: Global Rank Endpoint (Baseline, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery
Brief Summary: The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.


Options:
A: the incidence of postoperative nausea and vomiting(PONV) (After spinal surgery)
B: Cumulative usage of morphine 0-48 hours postoperatively (0-48 hours postoperatively)
C: Painscore during mobilization (2-24 hours after extubation time.)
D: Cumulative 24 Hour Oral Morphine Equivalent Consumption (24 hours (Day 1))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery
Brief Summary: The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.


Options:
A: pain during coughing (day 1)
B: Painscore during mobilization (2-24 hours after extubation time.)
C: N/A
D: Surgical wound infection (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery
Brief Summary: The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.


Options:
A: Major Perioperative Morbidity (30 day after surgery)
B: Painscore during mobilization (2-24 hours after extubation time.)
C: Postoperative nausea and vomiting (PONV) (24-32 hours postoperative)
D: Pain score by numeric rating scale (At 8 hours postoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: When and How to Administer Oxytocin for Active Management of Third Stage of Labour
Brief Summary: To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).


Options:
A: postpartum hemorrhage-1 (after delivery of baby); postpartum hemorrhage-2 (after delivery of the baby); postpartum hemorrhage-3 (after delivery of the baby)
B: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (baseline to discharge (2 - 3 days)); Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage (Initial hospital discharge (2-3 days)); Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors (baseline to discharge (2-3 days))
C: postpartum bleeding in the third stage of labour (participants will be followed for the duration of hospital stay, an expected average of 48 hours)
D: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: When and How to Administer Oxytocin for Active Management of Third Stage of Labour
Brief Summary: To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).


Options:
A: Need for Additional Uterotonic Medications (24 hours)
B: Mean change in hemoglobin (during 3rd trimester and 1-3 days postpartum)
C: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (baseline to discharge (2 - 3 days)); Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage (Initial hospital discharge (2-3 days)); Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors (baseline to discharge (2-3 days))
D: postpartum bleeding in the third stage of labour (participants will be followed for the duration of hospital stay, an expected average of 48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: When and How to Administer Oxytocin for Active Management of Third Stage of Labour
Brief Summary: To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).


Options:
A: Mean change in hemoglobin (during 3rd trimester and 1-3 days postpartum)
B: postpartum bleeding in the third stage of labour (participants will be followed for the duration of hospital stay, an expected average of 48 hours)
C: the amount of blood loss in third and fourth stages of labor (The end of the delivery to 2 hours after birth.)
D: Blood loss =>500 mls within one hour after enrollment

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
Brief Summary: This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic treatment over two weeks.


Options:
A: Change of self-reported pain on 100mm Visual Analogue Scale (VAS) (Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)); Change of functional status recorded with the Oswestry Disability Index (ODI) (Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days))
B: Pain Scores (Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up)
C: Leg Pain Intensity (Two weeks after randomization); Disability (Two weeks after randomization)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centred, Stepped Wedge, Cluster Randomised Controlled Trial to Compare the Clinical and Cost Effectiveness of a Complex Oral Health Care Intervention and Standard Oral Health Care in Stroke Care Settings: a Phase II Pilot Trial.
Brief Summary: Stroke associated pneumonia (SAP) affects a fifth of stroke survivors annually, tripling the risk of death at 30 days and contributing to poorer rehabilitation outcomes, prolonged hospital stays and dependency at discharge. Systematic review evidence indicates that enhanced oral health care (OHC) has a preventative effect on the incidence of pneumonia amongst nursing home populations (absolute risk reductions 6.6% to 11.7%; numbers needed to treat 8.6 to 15.3 individuals). There are strong theoretical reasons to suggest similar benefits might be observed in stroke care settings but current empirical evidence is weak - trial quality (randomisation, blinding, sample size, reporting), intervention description and thus feasibility of translation into clinical practice is very poor. Following an extensive pre-clinical programme of work, investigators now plan the pilot phase (Phase II) of a stepped-wedge cluster RCT of a well-developed and defined complex OHC intervention versus usual OHC. Investigators aim to establish a robust web-based randomisation process, refine the proposed intervention (training, tools, equipment), recruitment, adherence, record linkage and sampling methodologies. Investigators also aim to establish the relationship between SAP and plaque and any diversity between sites.


Options:
A: percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications (participants will be followed for the duration of hospital stay, an expected average of 2 weeks); a composite measure score of performance measures (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
B: Admission - brain imaging time (Hour 24); Admission- arrival at stroke unit time (Hour 24); Brain imaging time - arrival at stroke unit time (Hour 24); Admission period - thrombolysis time (door-to-needle time) (Hour 24)
C: Six minute walk test (walking ability) (1-3 months); Functional Independence Measure (1-3 months); Functional Ambulation Category (1-3 months)
D: Pneumonia (Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centred, Stepped Wedge, Cluster Randomised Controlled Trial to Compare the Clinical and Cost Effectiveness of a Complex Oral Health Care Intervention and Standard Oral Health Care in Stroke Care Settings: a Phase II Pilot Trial.
Brief Summary: Stroke associated pneumonia (SAP) affects a fifth of stroke survivors annually, tripling the risk of death at 30 days and contributing to poorer rehabilitation outcomes, prolonged hospital stays and dependency at discharge. Systematic review evidence indicates that enhanced oral health care (OHC) has a preventative effect on the incidence of pneumonia amongst nursing home populations (absolute risk reductions 6.6% to 11.7%; numbers needed to treat 8.6 to 15.3 individuals). There are strong theoretical reasons to suggest similar benefits might be observed in stroke care settings but current empirical evidence is weak - trial quality (randomisation, blinding, sample size, reporting), intervention description and thus feasibility of translation into clinical practice is very poor. Following an extensive pre-clinical programme of work, investigators now plan the pilot phase (Phase II) of a stepped-wedge cluster RCT of a well-developed and defined complex OHC intervention versus usual OHC. Investigators aim to establish a robust web-based randomisation process, refine the proposed intervention (training, tools, equipment), recruitment, adherence, record linkage and sampling methodologies. Investigators also aim to establish the relationship between SAP and plaque and any diversity between sites.


Options:
A: Rate of ventilator associated pneumonia (30 days)
B: Change in plaque scores over course of trial (Three week in-hospital rehabilitation period)
C: Pneumonia (Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.)
D: Pneumonia (2.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
Brief Summary: The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately.


Options:
A: Number of Subjects With Vaccine Response to Anti-gE Antibodies (At one month post-dose 2 (Month 3)); Vaccine Response for Anti-gE Humoral Immunogenicity (At one month post-dose 2 (Month 3)); Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies (At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)); FLU Haemagglutination Inhibition (HI) Antibody Titers (At Day 21 post vaccination)
B: Number of Subjects With Any Episodes of Herpes Zoster (HZ) (During the entire study period (3 to 5 year period following Day 0)); Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) (During the entire study period (3 to 5 year period following Day 0)); Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ (During the entire study period (3 to 5 year period following Day 0))
C: Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Anti-glycoprotein E (gE) Antibody Concentrations (One month after the second vaccination (Month 3)); Anti-VZV Antibody Concentrations (One month after the second vaccination (Month 3))
D: Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations (One month after dose 2, at Month 3); Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited Local Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Days With Solicited General Symptoms (During the 7-day (Days 0-6) period after each dose.); Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) (During the 30-day (Days 0-29) period after each dose.); Number of Subjects With Any and Related Serious Adverse Events (SAEs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)); Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) (From first vaccination (Month 0) up to 30 days post last vaccination (Month 3))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
Brief Summary: The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately.


Options:
A: Number of Subjects With a Vaccine Response for Anti-gE Antibodies (At Month 3); Anti-glicoprotein E (gE) Antibody Concentrations (At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)); Anti-pneumococcal Antibody Titers (At one month post-dose (Month 1)); Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups (At 1 month after vaccination); Adjusted GMCs Between Groups (At 1 month after last vaccine dose)
B: Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Anti-glycoprotein E (gE) Antibody Concentrations (One month after the second vaccination (Month 3)); Anti-VZV Antibody Concentrations (One month after the second vaccination (Month 3))
C: Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies (Baseline and 6 weeks following vaccine administration); Number of Participants Reporting an Adverse Experience (AE) (Up to 42 days following vaccine administration); Number of Participants Reporting a Serious Adverse Experience (SAE) (Up to 42 days following vaccine administration); Number of Participants Reporting a Serious Adverse Experience (Within 5 days after the blood draw at approximately 20 months following vaccine administration); Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) (Up to 5 days following vaccine administration); Number of Participants Reporting Systemic Adverse Experiences (Up to 42 days following vaccine administration); Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) (Up to 42 days following vaccine administration)
D: Number of Subjects With Vaccine Response to Anti-gE Antibodies (At one month post-dose 2 (Month 3)); Vaccine Response for Anti-gE Humoral Immunogenicity (At one month post-dose 2 (Month 3)); Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies (At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)); FLU Haemagglutination Inhibition (HI) Antibody Titers (At Day 21 post vaccination)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of an Enhanced Dietary Portfolio Plus Exercise on Cardiovascular Risk in High Risk Individuals.
Brief Summary: "Is it possible to recruit and retain up to 200 participants in a Randomize Control Trial (RCT) of high impact lifestyle approach of diet and exercise designed to significantly reduce cardiovascular events in middle-aged and older men and women at high risk of such events?" To address this question, we propose a pilot study of 3 years in duration: 1 year recruitment and randomization, a full year of intervention for all recruited participants, and the last 6 months to assess the one year data and prepare and submit the full trial application, informed by the pilot study outcomes in terms of retention rate. The pilot will then continue on for the full 9 years of intervention and be rolled into the main study involving additional Canadian centers and collaborating international centers in the US, Britain, Europe, Australia, New Zealand, India, and South Africa.


Options:
A: Glucose in mg/dl (12 weeks); Triglycerides in mg/dl (12 weeks); Insulin (12 weeks); Cholesterol in mg/dl (12 weeks)
B: Feasibility measured by recruitment and retention rates (1 year in a 9 year study)
C: Change in body weight from baseline (4 weeks)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of an Enhanced Dietary Portfolio Plus Exercise on Cardiovascular Risk in High Risk Individuals.
Brief Summary: "Is it possible to recruit and retain up to 200 participants in a Randomize Control Trial (RCT) of high impact lifestyle approach of diet and exercise designed to significantly reduce cardiovascular events in middle-aged and older men and women at high risk of such events?" To address this question, we propose a pilot study of 3 years in duration: 1 year recruitment and randomization, a full year of intervention for all recruited participants, and the last 6 months to assess the one year data and prepare and submit the full trial application, informed by the pilot study outcomes in terms of retention rate. The pilot will then continue on for the full 9 years of intervention and be rolled into the main study involving additional Canadian centers and collaborating international centers in the US, Britain, Europe, Australia, New Zealand, India, and South Africa.


Options:
A: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
B: Feasibility measured by recruitment and retention rates (1 year in a 9 year study)
C: body weight (prior to and after 4, 8, and 12 months of dieting)
D: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.

Answer: B