TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) in Smokers
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.

The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges).

The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.


Options:
A: Change in pulmonary health (dry cough, breath shortness, mouth irritation) index (baseline, 6 months, 12 months)
B: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)
C: smoking cessation (52 weeks)
D: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer
Brief Summary: Post-operative radiotherapy is internationally accepted as standard practice in the management of high-risk endometrial cancer1. Whilst it has no proven impact on overall survival it significantly increases local control.

Conventional radiotherapy techniques (3-dimensional) utilise a 3 or 4 field beam arrangement to target the pelvis in order to treat those areas at risk of recurrence: the vagina, the parametrium and the pelvic lymph nodes. However, when using such a technique it is not possible to avoid irradiating sensitive normal tissues such as the bowel and bladder.

Toxicity data from international randomised control trials in endometrial cancer report significantly more haematological, gastrointestinal, genitourinary and cutaneous toxicites (all grades) in those who received pelvic irradiation compared to those who did not2,3. These trials delivered radiotherapy using 2 or 3-dimensional techniques.

Intensity Modulated Radiation Therapy (IMRT) is a newer but established radiotherapy technique in many tumour sites that allows us to much more tightly conform the radiation. It uses computer-generated beams to produce radiotherapy volumes that can avoid irradiation of normal tissues in the pelvis.

There are no randomised studies reported in the literature that compare 3-dimensional pelvic irradiation with IMRT in patients who have had surgery for endometrial cancer. However there are several small studies that report considerable sparing of normal tissues using IMRT and when compared retrospectively with conventionally treated patients demonstrate marked reductions in acute gastrointestinal and genitourinary toxicity4.

By delivering post-operative radiotherapy to the pelvis using IMRT (as opposed to the standard 3-dimensional technique) it is anticipated that whilst local control and survival will be unaffected acute and late toxicity will be reduced.


Options:
A: Reduction in the incidence of ≥ grade 2 acute genitourinary (GU) and gastrointestinal (GI) toxicity according to NCI CTCAE v.3.0 (2015)
B: Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy (Up to 2 years)
C: Quality of Life (6 weeks after completion of radiotherapy)
D: Freedom from biochemical and/or disease failure rates (weekly during treatment, at 3 months, 6 months or 2 years then yearly)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Gender Differences in the Development and Prognosis of Coronary Disease Where Initial Disease Manifestation is Stable Angina, Myocardial Infarction or Unheralded Coronary Death: A CALIBER Study Using Linked GPRD-MINAP Data
Brief Summary: The initial manifestation of symptomatic coronary disease can range from angina (or symptoms of angina), unheralded acute coronary syndrome (ACS), or unheralded coronary death. A better understanding of gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease could help to identify which gender- specific factors might reduce or slow transition to more serious disease states and improve outcomes. The investigators' research focuses on the role primary care management of cardiovascular risk factors plays in gender differences in the progression to subsequent disease states and to mortality.


Options:
A: To demonstrate the efficacy of bedtime administration of ramipril in subjects with essential hypertension by testing the hypothesis of superior nocturnal SBP lowering in ABPM measurements compared with ramipril administered on awakening (Three months)
B: To evaluate the impact of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk assessment. (Yearly evaluation for at least ten years)
C: coronary mortality (ICD 10 I20-I25) (up to 15 years from entry into cohort)
D: Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks; Change from baseline in systolic 24 hour blood pressure after 12 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Gender Differences in the Development and Prognosis of Coronary Disease Where Initial Disease Manifestation is Stable Angina, Myocardial Infarction or Unheralded Coronary Death: A CALIBER Study Using Linked GPRD-MINAP Data
Brief Summary: The initial manifestation of symptomatic coronary disease can range from angina (or symptoms of angina), unheralded acute coronary syndrome (ACS), or unheralded coronary death. A better understanding of gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease could help to identify which gender- specific factors might reduce or slow transition to more serious disease states and improve outcomes. The investigators' research focuses on the role primary care management of cardiovascular risk factors plays in gender differences in the progression to subsequent disease states and to mortality.


Options:
A: Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First (Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.)
B: All cause mortality (3 years); Ventricular arrhythmias (3 years); Unplanned heart failure admissions (3 years)
C: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
D: coronary mortality (ICD 10 I20-I25) (up to 15 years from entry into cohort)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Gender Differences in the Development and Prognosis of Coronary Disease Where Initial Disease Manifestation is Stable Angina, Myocardial Infarction or Unheralded Coronary Death: A CALIBER Study Using Linked GPRD-MINAP Data
Brief Summary: The initial manifestation of symptomatic coronary disease can range from angina (or symptoms of angina), unheralded acute coronary syndrome (ACS), or unheralded coronary death. A better understanding of gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease could help to identify which gender- specific factors might reduce or slow transition to more serious disease states and improve outcomes. The investigators' research focuses on the role primary care management of cardiovascular risk factors plays in gender differences in the progression to subsequent disease states and to mortality.


Options:
A: Major cardiovascular events (5 years)
B: Time to symptomatic AF/atrial tachycardia (AT)/atrial flutter (AFl) lasting > 30 seconds more than 3 months post ablation. (at least 3 months post catheter ablation)
C: To evaluate changes from baseline in Left Ventricular Mass at 24M (24 months)
D: coronary mortality (ICD 10 I20-I25) (up to 15 years from entry into cohort)

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 BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control
Brief Summary: This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.


Options:
A: HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment (Baseline and 24 weeks); HbA1c Change From Baseline in Patients With Mild Renal Impairment (Baseline and 24 weeks); HbA1c Change From Baseline in Patients With Moderate Renal Impairment (Baseline and 24 weeks)
B: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)
C: Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) (Up to 5 years); Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) (Up to 5 years)
D: Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of CPAP Adherence Promotion by Peer Buddies With Sleep Apnea
Brief Summary: Obstructive sleep apnea (OSA) is a highly prevalent condition in veterans with some estimates as high as 47%. Poor adherence to the primary treatment of OSA -- continuous positive airway pressure (CPAP) therapy - is associated with increased risk for heart attacks, strokes and even death. The investigators plan to improve CPAP adherence in veterans through their interactions with peers who have successfully adopted CPAP therapy.

Such "peer-buddies" may promote the well-being of veterans while remaining highly cost-effective when compared to healthcare providers. Our strategy is grounded on the rationale that veterans as a group are ecoculturally more homogenous than expected for the given level of differences in age, gender, ethnicity, or socioeconomic strata. Our long-term objectives are to initiate a larger, multi-site, research study for enhancing CPAP adherence in veterans with OSA. The ultimate goal of this research is to develop a cheap, effective and exportable system of care to promote CPAP adherence in patients with OSA.


Options:
A: Structural and functional brain changes (at baseline and after 3 months of treatment)
B: Functional Outcomes of Sleep Questionnaire (FOSQ) (Three months)
C: Effect of intensive intervention on CPAP adherence (24 months)
D: CPAP Therapy Adherence (30 days post in-lab split night polysomnogram)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HZA106827: A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Parallel Group Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder Alone in the Treatment of Persistent Asthma in Adults and Adolescents
Brief Summary: The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.


Options:
A: Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12 (Baseline and Week 12)
B: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
C: Safety：adverse events, vital sign, ECGs, and clinical laboratory test; PK：Cmax, tmax and AUC(0-t)
D: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HZA106827: A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Parallel Group Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder Alone in the Treatment of Persistent Asthma in Adults and Adolescents
Brief Summary: The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.


Options:
A: Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12 (Baseline and Week 12)
B: Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26 (26 weeks)
C: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)
D: Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12 (Baseline and Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HZA106827: A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Parallel Group Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder Alone in the Treatment of Persistent Asthma in Adults and Adolescents
Brief Summary: The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.


Options:
A: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks. (Baseline and 12 weeks)
B: non-inferiority in the efficacy of FlutiForm® (baseline to the end of the 12 week treatment)
C: Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12 (Baseline and Week 12)
D: Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12 (Baseline and Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Brief Summary: The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years.

Two studies \[ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)\] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.


Options:
A: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). (At Month 30 after the first vaccination.); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 30 after the first vaccination); Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination)
B: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))
C: Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA). (At one month (M1) after Dose 2); Concentrations of Antibodies Against Anti-gE as Determined by ELISA. (At one month (M1) after Dose 2)
D: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Brief Summary: The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years.

Two studies \[ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)\] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.


Options:
A: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))
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 Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))
D: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Brief Summary: The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years.

Two studies \[ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)\] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.


Options:
A: Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))
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: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))
D: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))

Answer: C