TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Large, International, Placebo-controlled, Factorial Trial to Assess the Impact of Clonidine and Acetyl-salicylic Acid (ASA) in Patients Undergoing Noncardiac Surgery Who Are at Risk of a Perioperative Cardiovascular Event
Brief Summary: Major surgeries not involving the heart are common, and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. There is encouraging data suggesting that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery.


Options:
A: Pain at the mobilization (At the first 48 hours postoperatively)
B: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
C: Pain 'Right Now' (24 hours after the end of surgery); Morphine Equivalents of Concomitant Pain Medication (24 hours after the end of surgery)
D: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Large, International, Placebo-controlled, Factorial Trial to Assess the Impact of Clonidine and Acetyl-salicylic Acid (ASA) in Patients Undergoing Noncardiac Surgery Who Are at Risk of a Perioperative Cardiovascular Event
Brief Summary: Major surgeries not involving the heart are common, and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. There is encouraging data suggesting that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery.


Options:
A: The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion (At baseline and 15 minutes after starting study drug (prior to topicalization), and every 3 minutes thereafter throughout study drug infusion, at the end of topicalization, and prior to administration of any rescue medication.)
B: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
C: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Portable Electronic(USB)and Paper Medical Records as an Adjunct to Usual Care (Portable Health File RCT): an Evaluation of Short Term Quality Measures and Long-term Clinical Outcomes
Brief Summary: The PHF trial will assess the acceptability and long term outcomes resulting from the usage of electronic (carried by the patient on a USB memory device) and paper portable health files in a population with high intensity use of medical services. The rationale is that use of the portable health files provides a conduit of direct communication among health care providers of a patient's important health care information and this leads to better care and patient outcomes.

Primary hypothesis: Addition of a patient-held portable health file (PHF) to usual care improves patient outcome and quality-of-life compared to usual care alone.

Secondary hypothesis: Addition of patient-held portable health file (PHF) to usual care is acceptable and satisfactory to patients and their health care providers.


Options:
A: Change in Patient Health Questionnaire-9 items (PHQ-9) score (Baseline, 3-month, 6-month, 9-month, 12-month)
B: Weight change
C: The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study. (6 months)
D: Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events (48 months + 36 month extension)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Portable Electronic(USB)and Paper Medical Records as an Adjunct to Usual Care (Portable Health File RCT): an Evaluation of Short Term Quality Measures and Long-term Clinical Outcomes
Brief Summary: The PHF trial will assess the acceptability and long term outcomes resulting from the usage of electronic (carried by the patient on a USB memory device) and paper portable health files in a population with high intensity use of medical services. The rationale is that use of the portable health files provides a conduit of direct communication among health care providers of a patient's important health care information and this leads to better care and patient outcomes.

Primary hypothesis: Addition of a patient-held portable health file (PHF) to usual care improves patient outcome and quality-of-life compared to usual care alone.

Secondary hypothesis: Addition of patient-held portable health file (PHF) to usual care is acceptable and satisfactory to patients and their health care providers.


Options:
A: Weight change
B: Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL (12 months)
C: Prevalence of latent heart failure and COPD. (6 months)
D: Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events (48 months + 36 month extension)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis
Brief Summary: The aim of the study is correlating efficacy of the treatment to the proportion of paclitaxel-dose supplied by the catheter. Forty-five patients each will be treated by paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in the superficial femoral or popliteal artery, main exclusion criteria are related to the use of paclitaxel and the need for follow-up examinations. Either clinical or angiographic follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary endpoint is 6-month angiographic late lumen loss. Secondary endpoints are further angiographic and clinical efficacy and various safety criteria.


Options:
A: Late lumen loss (6 months)
B: Primary Patency (12 month); Primary Safety Composite (12 month)
C: Safety: Major adverse event rate (MAE), defined as all cause death, major amputation of target extremity, target lesion thrombosis, target lesion revascularisation (TLR)and target vessel revascularization (TVR) at 30 days. (30 days); Performance: Target lesion primary patency rate at 6 months assessed by quantitative vascular angiogram (QVA). (6 months)
D: angiographic binary re-restenosis (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Paclitaxel Eluting Balloon or Conventional Balloon for Treatment of In-Stent Restenosis of the Superficial Femoral Artery in Patients With Symptomatic Peripheral Artery Disease (ISAR-PEBIS)
Brief Summary: The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.


Options:
A: Freedom From Target Lesion Revascularization (TLR) (6 months); Freedom From Major Adverse Events (MAE) (30 days)
B: angiographic binary re-restenosis (12 months)
C: primary patency rate (6 months)
D: Percentage diameter stenosis (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Care Interventions With 0.12% Chlorhexidine and Ventilator Associated Pneumonia in Critically Ill Children: Prospective, Randomic and Double Blind Study
Brief Summary: This experimental study aims to verify the influence of the oral hygiene performance with chlorhexidine digluconate 0.12% in the development of VAP in children. The data collection begun in April, 2005 during the performance of the masters degree course dissertation entitled "Clinical study about the effect of the oral hygiene with chlorhexidine digluconate 0.12% in the oropharynx colonization of children in intensive care", being performed in a PICU of nine beds in a university hospital in the city of São Paulo, after approval of the Research Ethics Committee of the institution. The study is composed by three types of variables: Independent variable, dependent variables, and complementary variables. The categorical variables will be analyzed in accordance with the Person's Chi-Square test of or Fisher's exact test. The numerics will be submitted to the analysis of variance ANOVA or Kruskall Wallis. For variables with heterogeneous distribution between the groups, the multivariate analysis will be applied to the evaluation of the influence in the determination of the development risk of the dependent variable. The rejection level will be fixed in 0.05 of the nullity hypothesis.


Options:
A: Ventilator associated pneumonia (48 hours after tracheal intubation)
B: Development of Ventilator Acquired Pneumonia (During the period of intubation)
C: N/A
D: Ventilator-Associated Pneumonia (VAP) (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Care Interventions With 0.12% Chlorhexidine and Ventilator Associated Pneumonia in Critically Ill Children: Prospective, Randomic and Double Blind Study
Brief Summary: This experimental study aims to verify the influence of the oral hygiene performance with chlorhexidine digluconate 0.12% in the development of VAP in children. The data collection begun in April, 2005 during the performance of the masters degree course dissertation entitled "Clinical study about the effect of the oral hygiene with chlorhexidine digluconate 0.12% in the oropharynx colonization of children in intensive care", being performed in a PICU of nine beds in a university hospital in the city of São Paulo, after approval of the Research Ethics Committee of the institution. The study is composed by three types of variables: Independent variable, dependent variables, and complementary variables. The categorical variables will be analyzed in accordance with the Person's Chi-Square test of or Fisher's exact test. The numerics will be submitted to the analysis of variance ANOVA or Kruskall Wallis. For variables with heterogeneous distribution between the groups, the multivariate analysis will be applied to the evaluation of the influence in the determination of the development risk of the dependent variable. The rejection level will be fixed in 0.05 of the nullity hypothesis.


Options:
A: Feasibility (duration of study, for up to 30 months); Duration of Mechanical Ventilation (3 days)
B: Prevention of ventilator-associated pneumonia (60 days)
C: Ventilator associated pneumonia (48 hours after tracheal intubation)
D: Rate of ventilator associated pneumonia (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama
Brief Summary: The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).


Options:
A: Complete clinical cure (six months)
B: 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))
C: Change of Lesion size (6 months)
D: Number of Participants Who Obtained Final Clinical Cure of Index Lesion (168 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Linagliptin (5 mg) Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients (Age >= 70 Years) With Insufficient Glycaemic Control( HbA1c >= 7.0) Despite Metformin and/or Sulphonylurea and/or Insulin Therapy
Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control


Options:
A: N/A
B: HbA1c Change From Baseline to Week 24 (Baseline and week 24)
C: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)
D: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Trial of Induction Chemotherapy Followed by Cetuximab (Erbitux) With Low Dose vs. Standard Dose IMRT in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high energy x-rays to kill tumor cells. Giving paclitaxel, cisplatin, and cetuximab together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying paclitaxel, cisplatin, and cetuximab to see how well they work when followed by cetuximab and two different doses of intensity-modulated radiation therapy in treating patients with HPV-associated stage III or stage IV cancer of the oropharynx that can be removed by surgery.


Options:
A: Overall Survival Time (OS) (time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007)
B: Overall Survival (3-years)
C: 24-month Progression-free Survival (assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry)
D: Overall Survival (Percentage of Participants Alive) (From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries
Brief Summary: Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.


Options:
A: Neonatal Composite Outcome (72 hours of life)
B: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
C: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
D: Incidence of respiratory morbidity (72 hours after birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries
Brief Summary: Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.


Options:
A: Incidence of respiratory morbidity (72 hours after birth)
B: Respiratory distress syndrome; Intraventricular hemorrhage; Neonatal mortality
C: severe RDS defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life (48 hours of life)
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries
Brief Summary: Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.


Options:
A: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years
B: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
C: Incidence of respiratory morbidity (72 hours after birth)
D: severe RDS defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life (48 hours of life)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries
Brief Summary: Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.


Options:
A: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
B: Incidence of respiratory morbidity (72 hours after birth)
C: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
D: Neonatal Composite Outcome (72 hours of life)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries
Brief Summary: Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.


Options:
A: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
B: Neonatal Composite Outcome (72 hours of life)
C: Incidence of respiratory morbidity (72 hours after birth)
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries
Brief Summary: Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.


Options:
A: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
B: Neonatal Composite Outcome (72 hours of life)
C: neonatal respiratory distress (neonatal period (28 days of life))
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries
Brief Summary: Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.


Options:
A: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
B: Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
C: N/A
D: perinatal mortality (Jan 1999-Dec 2003)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries
Brief Summary: Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.


Options:
A: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)
B: Neonatal Composite Outcome (72 hours of life)
C: Incidence of respiratory morbidity (72 hours after birth)
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries
Brief Summary: Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.


Options:
A: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
B: The Neonatal Pain, Agitation, and Sedation scale (8 month)
C: success rate in closing PDA using paracetamol in comparison to ibuprofen. (at Visit 3 (day 3).)
D: Ductus diameter mm/kg (at postnatal age of 5 days); Cumulative dosage of morphine (at postnatal age of 5 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of the Use of Antenatal Corticosteroids in Developing Countries
Brief Summary: Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.


Options:
A: Incidence of respiratory morbidity (72 hours after birth)
B: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
C: Need for mechanical ventilation (Death or discharge from the NICU)
D: Neonatal Composite Outcome (72 hours of life)

Answer: B