TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study to Determine the Feasibility of Conducting a Randomized Clinical Trial Comparing Fondaparinux Sodium (Arixtra) Once Daily With Enoxaparin (Lovenox®) Twice Daily With Respect to Preventing VTE After Bariatric Surgery in Obese Patients
Brief Summary: This pilot study is designed to determine the feasibility of conducting a randomized clinical trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®) twice daily with respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after bariatric surgery in obese patients.


Options:
A: To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery. (2 years)
B: 2 week mortality (2 weeks after admission at ICU)
C: Total Number of Patients Who Were Alive and Without Venous/Thrombotic Events in ICU (Discharge from ICU or 30 days)
D: Mortality and days free of organ support (21 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure
Brief Summary: This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.


Options:
A: Change from baseline in diastolic blood pressure after 52 weeks
B: 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)
C: To investigate the combined effect of aliskiren and valsartan on vascular structure, assessed by wall to lumen ratio of retinal arterioles, in hypertensive patients. (After 8 weeks of treatment with aliskiren versus placebo)
D: Change from baseline in diastolic blood pressure after week 8

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of 52 Weeks Treatment With Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
Brief Summary: This study will assess the effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and overall safety and tolerability will also be assessed.


Options:
A: Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) (From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).)
B: Progression of Albuminuria (Up to 3 years)
C: To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF). (52 weeks)
D: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DaVita Assessment of Nutritional Supplement Effects
Brief Summary: This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients will be randomized to either receive one can of Nepro with Carb Steady at each dialysis treatment for 6 months or to receive the standard of care counseling for malnutrition. The primary hypothesis is that hypoalbuminemic maintenance hemodialysis patients will demonstrate an improvement in albumin levels with oral nutritional supplement provided in-center thrice weekly in addition to standard of care as compared to malnourished maintenance hemodialysis patients provided standard of care alone.


Options:
A: Serum albumin (Change from baseline serum albumin at 6 months of the study); Body mass index (BMI) (Change from BMI at 6 months of the study)
B: increase in serum albumin (6 months)
C: The primary outcome measure of this study is albumin level, both mean albumin level and percentage of patients achieving an albumin level of >3.8 and > 4.0 (Monthly for the 6 month study period)
D: Number of patients who correct the state of protein energy wasting in intervention group compared to a control group (at 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Early Psychological Intervention to Prevent PTSD
Brief Summary: This study will examine the use of prolonged exposure therapy on people who have recently experienced a trauma to prevent them from developing post-traumatic stress disorder.


Options:
A: PTSD Symptom Scale- I (PSS) (Measured 4 and 12 weeks post-trauma)
B: Diagnosis of Post Traumatic Stress Disorder (3 months post critical illness)
C: Davidson Trauma Scale (6 months); BDI-II (6 months)
D: Post-traumatic Stress Disorder (chronic) by CAPS scores. (Four months, seven months, 14 moths, two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Early Psychological Intervention to Prevent PTSD
Brief Summary: This study will examine the use of prolonged exposure therapy on people who have recently experienced a trauma to prevent them from developing post-traumatic stress disorder.


Options:
A: Change in telomerase activity (pre-intervention (baseline) and post-intervention (5.5 months later))
B: PTSD Symptom Scale- I (PSS) (Measured 4 and 12 weeks post-trauma)
C: Number of Participants Receiving Prolonged Exposure Treatment via Telemedicine with significantly decreased PTSD symptoms Compared to Number of Participants Receiving Prolonged Exposure Treatment with Standard In-Person Delivery (36 weeks)
D: Depression, PTSD (Change from 0-12 weeks, 12-24 weeks and 24-36 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial
Brief Summary: The implantable cardioverter defibrillator (ICD) is generally well-accepted by patients, but a subgroup experiences increased anxiety and poor quality of life. A web-based behavioral intervention may comprise a novel approach to reduce anxiety and enhance well-being in ICD patients, which may be equally effective and have advantages over more traditional forms of therapy, due to its low-threshold accessibility via the internet.

The purpose of this study is to determine whether patients receiving a behavioral intervention via the internet experience less anxiety and device concerns and improved quality of life compared to patients receiving usual care.


Options:
A: Hamilton Rating Scale for Depression (HAM-D-17) (12 weeks post-randomization)
B: Death (4 months); Death (8 months); Death (12 months); Death (16 months); Death (20 months); Death (24 months); Death (3 years); Death (4 years); Stroke/Systemic embolism (SE) (4 months); Stroke/Systemic embolism (SE) (8 months); Stroke/Systemic embolism (SE) (12 months); Stroke/Systemic embolism (SE) (16 months); Stroke/Systemic embolism (SE) (20 months); Stroke/Systemic embolism (SE) (24 months); Stroke/Systemic embolism (SE) (3 years); Stroke/Systemic embolism (SE) (4 years); Major bleeding (4 months); Major bleeding (8 months); Major bleeding (12 months); Major bleeding (16 months); Major bleeding (20 months); Major bleeding (24 months); Major bleeding (3 years); Major bleeding (4 years)
C: Anxiety (Baseline); Anxiety (14 weeks); Anxiet (26 weeks); Anxiety (52 weeks)
D: Beck Depression Inventory-II (Measured at Baseline and 10 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting
Brief Summary: To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.


Options:
A: The average depths of hypnosis as assessed by the BIS and the cAAI between skin incision and start of closure. (During anaesthesia); Postoperative nausea as assessed by a verbal rating scale (VRS) ranging between 0 and 10. (After anesthesia at 5, 10, 15, 30, 45, 60, and 90 min. At 2, 6 and 24 h after anesthesia the maximum nausea will be rated for the 30-120 min, 2-6 h, and 6-24 h interval.); Reduction of VRS nausea immediately at 2, 5, 7.5, 10, 15, 20 and 30 min after rescue treatment administration. (Maximum nausea will be rated at 2, 6 and 24 hours after treatment for the 30-120 min, 2-6 h and 6-24 h interval.)
B: Rates of vomiting and retching (after surgery)
C: Experienced Post-operative Nausea or Vomiting (24 hours)
D: severity of nasea (immediated postop to 48hrs after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.


Options:
A: Apathy Evaluation Scale (AES) (baseline to 6 weeks); Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (baseline to 6 weeks)
B: Apathy Evaluation Scale Score at 12 Weeks (At 12 weeks)
C: NeuroBehavior Rating Scale-- Agitation (9 weeks); Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC) (Baseline to 9 weeks)
D: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks (Baseline (randomization), 76 weeks); Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug (Baseline (randomization), 16 weeks following treatment cessation); Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks (Baseline (randomization), 76 weeks); Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug (Baseline (randomization), 16 weeks following treatment cessation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.


Options:
A: Cohen-Mansfield Agitation Inventory - long form (CMAI) (CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.)
B: NeuroBehavior Rating Scale-- Agitation (9 weeks); Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC) (Baseline to 9 weeks)
C: Cohen-Mansfield (2 weeks)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
Brief Summary: This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.


Options:
A: Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year (12 months); Rate of Exacerbations Per Subject-year (12 months)
B: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks (Baseline and Weeks 2 to 52)
C: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
D: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
Brief Summary: This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))
B: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal)
C: Forced Expiratory Volume in 1 Second (FEV1) Pre-dose (Baseline to 12 weeks)
D: Standardized Dyspnea Score at Isotime During Exercise (2 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
Brief Summary: This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.


Options:
A: Percentage Change in Exercise Tolerance From Baseline at 2 Weeks (Baseline and after 2 weeks with each treatment)
B: Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) (From the start of study drug up to 52 weeks)
C: Trough FEV1 Response (Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29)
D: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
Brief Summary: This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.


Options:
A: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84) (From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84))
B: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (after 12 weeks)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))
D: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
Brief Summary: This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.


Options:
A: morning peak expiratory flow rate (PEFR) (50 weeks)
B: Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment (4 hour period following inhalation of study treatment)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)
D: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing Rapid Bronchodilatory Effect of Formoterol and Salbutamol in Children Between 5-15 Years With Mild to Moderate Acute Exacerbation of Asthma- A Double Blind Randomized Controlled Trial
Brief Summary: The hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled Formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e., the difference in mean forced expiratory volume in 1 second (FEV1) between the 2 groups at 1, 5, 10, 30 and 60 minutes will be less than 10% in children between 5-15 years with mild acute exacerbation of asthma.


Options:
A: Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks (Baseline and Visit 6)
B: The primary outcome for comparison across treatment groups was the mean value of morning PEF measured during the last 2 weeks of treatment (weeks 23-24)
C: Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes (60 min)
D: The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study (week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults
Brief Summary: The goal of the study is to investigate the efficacy of an evidence-based weight loss intervention, on a background of quality health care, on asthma control among obese adults. The intervention will employ a combination of recommended dietary and physical activity changes, and behavioral modification techniques.


Options:
A: Clinical Control (Before and after 3 months of intervention)
B: psychosocial morbidity and airway inflammation (3 months)
C: Asthma Control Questionnaire (Baseline, 6- and 12-months)
D: Bronchial hyperresponsiveness (Before and after 3 months of intervetion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
Brief Summary: The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma.


Options:
A: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)
B: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)
C: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
D: Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. (Baseline and 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
Brief Summary: The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma.


Options:
A: Efficacy (24 months)
B: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
C: Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds (12 months)
D: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
Brief Summary: The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma.


Options:
A: Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data (Baseline; Month 24 postoperative)
B: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
C: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)
D: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)

Answer: D