TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twenty Six-week, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension
Brief Summary: This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension


Options:
A: Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months (6 months)
B: Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment (Baseline, 104 weeks)
C: Change from baseline in diastolic blood pressure after 52 weeks
D: Change from baseline in diastolic blood pressure after 8 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes
Brief Summary: This trial is conducted in North America (the United States of America (USA) and Mexico).

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).


Options:
A: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)
B: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment (Baseline and 52 weeks); Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment (Baseline and 76 weeks)
C: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (week 0, week 52); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 (week 0, week 104); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 (week 0, week 156)
D: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes
Brief Summary: This trial is conducted in North America (the United States of America (USA) and Mexico).

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).


Options:
A: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (week 0, week 52); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 (week 0, week 104); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 (week 0, week 156)
B: N/A
C: Full Epithelialization of the Wound (3 months of treatment with vildagliptin); Capillary Density (3 months of treatment with vildagliptin)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes
Brief Summary: This trial is conducted in North America (the United States of America (USA) and Mexico).

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).


Options:
A: Change in HbA1c From Baseline to Week 26 (Baseline, Week 26)
B: Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 (Week 0, Week 26); Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Week 0, Week 52); Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 (Week 0, Week 78); Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 (Week 52, Week 78)
C: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (week 0, week 52); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 (week 0, week 104); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 (week 0, week 156)
D: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 (Baseline and Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Community Occupational Therapy on the Daily Performance of Older Patients With Mild to Moderate Dementia and on the Sense of Competence of Their Primary Caregivers.
Brief Summary: The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers.


Options:
A: 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);; 2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);; 3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
B: Primary Outcome Measure(s) evaluate the efficacy and cost-effectiveness of the intervention in reducing carer burden, improving behaviour problems in elderly persons with dementia and reducing the costs of illness. (by the end of the study)
C: Neuropsychiatric Inventory; Cornell Depression in Dementia Scale; Activities of Daily Living
D: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Community Occupational Therapy on the Daily Performance of Older Patients With Mild to Moderate Dementia and on the Sense of Competence of Their Primary Caregivers.
Brief Summary: The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers.


Options:
A: The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. (Baseline, 4 month (short-term follow-up), 8 month (long-term))
B: 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);; 2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);; 3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
C: Neuropsychiatric inventory (NPI) score (NPI score will be measured at 7 months)
D: Behavioral occurrence; Care recipient depressive mood; Caregiver upset

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Community Occupational Therapy on the Daily Performance of Older Patients With Mild to Moderate Dementia and on the Sense of Competence of Their Primary Caregivers.
Brief Summary: The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers.


Options:
A: Frequency by severity of Agitated and Aggressive Behavior in person with dementia (3 months)
B: 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);; 2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);; 3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
C: Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) (Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
D: ADL/IADL (Baseline, t2, t3); Caregiver upset (Baseline, t2, t3); Caregiver confidence (when needed); Behaviors (Baseline, t2, t3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Late Steroid Rescue Study (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
Brief Summary: The purpose of this study is to assess innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS.


Options:
A: All cause mortality (28 days)
B: Mortality rates (measured at time of hospital discharge or 60 days after study entry)
C: Duration of mechanical ventilation (0-28 days)
D: Septic shock (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Late Steroid Rescue Study (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
Brief Summary: The purpose of this study is to assess innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS.


Options:
A: change in extravascular lung water within 7 days of treatment (change from baseline - day 7)
B: Compare the adverse events between mesenchymal stem cell treatment and placebo groups (From day 0 at the start of treatment to day 28.)
C: Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) (Measured at Months 6 and 12)
D: Mortality rates (measured at time of hospital discharge or 60 days after study entry)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Late Steroid Rescue Study (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
Brief Summary: The purpose of this study is to assess innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS.


Options:
A: Mortality (Measured at Months 3, 6, 12, 24, 36, 48 and 60)
B: Mortality rates (measured at time of hospital discharge or 60 days after study entry)
C: 28-day mortality from all causes (28 days)
D: Reduction of the mortality rate of ARDS patients at d90 (36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Late Steroid Rescue Study (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
Brief Summary: The purpose of this study is to assess innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS.


Options:
A: Reduction of the mortality rate of ARDS patients at d90 (36 months)
B: Mortality rates (measured at time of hospital discharge or 60 days after study entry)
C: ventilator dependent status
D: Effect of early IVIG versus placebo on CIPNM on day 14 (day 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.


Options:
A: Vascular function (Measured at weeks 4 and 12)
B: Glycemic control (6 months)
C: adherence, HbA1c, Glc
D: insulin sensitivity as determined by euglycemic clamp tests (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial on Efficacy and Safety of the Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth (ACG Trial)
Brief Summary: Administration of steroid to the mother in imminent preterm delivery is a known effective practice to decrease the risk of respiratory distress syndrome and intraventricular haemorrhage in preterm infants if given with a week of the preterm delivery. This randomized clinical trial is performed to test the possibility whether the repeat dose of steroid results in further reduction of these diseases in case the mother is in imminent preterm delivery more than a week after the first antenatal steroid treatment.


Options:
A: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years
B: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
C: 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)
D: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial on Efficacy and Safety of the Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth (ACG Trial)
Brief Summary: Administration of steroid to the mother in imminent preterm delivery is a known effective practice to decrease the risk of respiratory distress syndrome and intraventricular haemorrhage in preterm infants if given with a week of the preterm delivery. This randomized clinical trial is performed to test the possibility whether the repeat dose of steroid results in further reduction of these diseases in case the mother is in imminent preterm delivery more than a week after the first antenatal steroid treatment.


Options:
A: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
B: 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)
C: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years
D: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial on Efficacy and Safety of the Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth (ACG Trial)
Brief Summary: Administration of steroid to the mother in imminent preterm delivery is a known effective practice to decrease the risk of respiratory distress syndrome and intraventricular haemorrhage in preterm infants if given with a week of the preterm delivery. This randomized clinical trial is performed to test the possibility whether the repeat dose of steroid results in further reduction of these diseases in case the mother is in imminent preterm delivery more than a week after the first antenatal steroid treatment.


Options:
A: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years
B: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
C: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Doxazosin on Ambulatory Blood Pressure and Sympathetic Nervous Activity in Hypertensive Patients With Diabetic Nephropathy
Brief Summary: Few studies have reported the effect of alpha1-adrenergic antagonists on 24-h blood pressure and regulation of sympathetic nervous activity in hypertensive patients with diabetic nephropathy. Using ambulatory blood pressure monitoring devices equipped with spectral analysis of heart rate variability, we assess the effects of doxazosin on blood pressure in diabetic nephropathy patients and compare the results with those in patients with essential hypertension, patients with diabetes mellitus and patients with chronic nephropathy.


Options:
A: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
B: Normalization of high blood pressure (One year)
C: Change from baseline in diastolic blood pressure after 26 weeks
D: Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)). (baseline to 18 weeks of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)
Brief Summary: The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.


Options:
A: Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) (Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.); Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) (Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.)
B: DFS (5 Years)
C: all cause recurrence (the first 5 years after surgery)
D: Mammographic percentage density at 18months (18months after enrolled)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)
Brief Summary: The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.


Options:
A: Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) (Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.); Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) (Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.)
B: Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) (Up to 34 months)
C: Increase in apoptotic index between diagnostic core biopsy and repeat core biopsy taken on day 5 (Repeat biopsy on day 5 (+/- day 21))
D: Disease-free survival as assessed annually for 10 years

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial of Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Carboplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
Brief Summary: To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer


Options:
A: Overall Survival (From entry into the study to death or the date of last contact, assessed up to 5 years); Progression-free Survival (From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)); Tumor Response (Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.); To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study. (From date of enrollment until 30 days after treatment completion)
B: Progression-free survival (48 months); Overall survival (48 months)
C: Anti-tumor Activity as Measured by Surviving Progression-free (Progression-free survival at 6 months)
D: overall survival (During the study conduct)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria
Brief Summary: The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.


Options:
A: Fractional excretion of sodium (5 days treatment)
B: Relative reduction in circulating osteoprotegerin levels (18 weeks)
C: Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) (Entire follow-up (median = 4.35 years))
D: Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. (Assessed at Week 52, Last observation carried forward (LOCF))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, 52-wk, Parallel-grp Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Non-diabetic Patients With Moderate Proteinuria
Brief Summary: The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate proteinuria and hypercholesterolaemia.


Options:
A: Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
B: Median Percent Change in Triglycerides From Baseline to Week 8. (Baseline to 8 weeks)
C: 24-hour urinary protein excretion rate, at the end of 6 months treatment phase (At 0, 2,3,4,5,6,7,8,9,10 months.)
D: Urinary Protein/Creatinine Ratio at Week 52 [LOCF] (Assessed at baseline and Week 52 (LOCF))

Answer: D