TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Brief Summary: This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).


Options:
A: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
B: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
C: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Brief Summary: This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).


Options:
A: Global cognitive functioning (26 weeks)
B: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
C: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
D: Working Memory function. (Changes from baseline (3, 6 and 12 months after intervention).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Brief Summary: This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).


Options:
A: Neuropsychological testing (Baseline, 12 weeks, and 24 weeks); Oddball task (Baseline, 12 weeks, and 24 weeks); Wisconsin task (Baseline, 12 weeks, and 24 weeks); Speed of processing task (Baseline, 12 weeks, and 24 weeks); Spatial working memory (WM) (Baseline, 12 weeks, and 24 weeks)
B: Aggregate Cognitive Performance (Baseline to 10 weeks)
C: Activity Compliance (Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks)
D: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Brief Summary: This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).


Options:
A: Global cognitive functioning (26 weeks)
B: Aggregate Cognitive Performance (Baseline to 10 weeks)
C: The study investigates changes in a neuropsychological assessment battery pre-randomization; and upon the completion of training.
D: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Brief Summary: This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).


Options:
A: Aggregate Cognitive Performance (Baseline to 10 weeks)
B: sleep measures (3-6 months)
C: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
D: Global cognitive functioning (26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study Comparing the Duration of Sequential Therapy
Brief Summary: Background: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurence or recurrence of these diseases. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy and need to be rescued with third line therapy. In recent years, the concept of sequential therapy has been advocated in the treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another five days. The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90%. More importantly, it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89%. However, tinidazole is not available in many countries. Whether metronidazole would be an effective alternative to tinidazole in the sequential therapy remains unknown. Besides, whether extending the duration of sequential therapy from 10-day to 14-day would result in higher eradication rate also deserves further investigation. Furthermore, data on the efficacy of rescue regimens for patients who failed from first line sequential therapy are also lacking. The impact of clarithromycin, metronidazole resistance and CYP2C19 polymorphism on the sequential therapy containing metronidazole (rather than tinidazole) also has not been reported.

Aims: Therefore, we aim to assess

1. whether the substitution of metronidazole for tinidazole in the sequential therapy is also more effective than clarithromycin-based triple therapy
2. whether extending the duration of sequential therapy from 10-day to 14-day would achieve higher eradication rate
3. whether levofloxacin-based sequential therapy for 14-days is effective as second line rescue regimen for those who failed from first line sequential therapy
4. the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of sequential therapy


Options:
A: Number of Participants With Complete Eradication of Helicobacter Pylori (at the 6th week after the end of anti- H. pylori therapy)
B: H pylori eradication rate (at least 4 weeks up to 24 weeks after finishing course of antibiotics)
C: Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis (6 weeks after eradication therapy)
D: Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori (6 months (Feb 2014))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Energy Dense Oleic Acid Rich Formula to Newly Admitted Geriatric Patients - Feasibility and Effects on Energy Intake
Brief Summary: Background and aims:

Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on energy intake and appetite were studied.

Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were randomised to receive a fat emulsion (Calogen, intervention group (IG)) or to standard care (control group (CG)). Thirty ml of the emulsion were given 3 times daily, i.e. 420 kcal, and was distributed at the regular medication rounds. Food intake and self-rated appetite were registered 2-3 days after admission and on day 8 or the day prior to discharge. Nutritional risk screening (NRS) 2002 and serum lipids and fatty acid profiles were analysed.


Options:
A: The primary outcome measure is Quality of Life (6 months)
B: To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power. (5 days to 3 weeks intervention)
C: cognitive decline (33 months)
D: mean dietary intake of inpatients during a 24 hour period (end of year 1 and year 2)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)
Brief Summary: The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.


Options:
A: Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry. (Post surgery based on upto 36-week treatment)
B: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants (Baseline up to approximately 34 months); PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) (Baseline up to approximately 34 months); Overall Survival (OS) in All Randomized Participants (Baseline until death due to any cause (up to approximately 58 months)); OS in Participants With Detectable PD-L1 (Baseline until death due to any cause (up to approximately 58 months))
C: Progression-Free Survival (PFS) (Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.)
D: Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) (Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)
Brief Summary: The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.


Options:
A: Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry. (Post surgery based on upto 36-week treatment)
B: pathological complete response (pCR= ypT0/is ypN0) (18 weeks (time window + 3 weeks)); Only for those patients randomized for the supportive anemia treatment: frequency of patients reaching hemoglobin (Hb) levels ≥ 11g/dl 6 weeks after treatment start of a first episode of anemia grade ≥2 (18 weeks (time window + 3 weeks))
C: response by pCR =ypT0/is ypN0 (24 weeks)
D: disease-free survival in patients treated with either 6 cycles of Docetaxel / Cyclophosphamide chemotherapy or 4 cycles of EC followed by 4 cycles of Docetaxel as adjuvant treatment (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
Brief Summary: This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.


Options:
A: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) (Baseline to 8 weeks)
B: Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12 (Baseline and Week 12)
C: Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization (up to End of Study (78 months))
D: Evaluate safety through adverse events and laboratory abnormalities after 8 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Status and Dose Response in Infants
Brief Summary: This study will examine the relationship of serum 25(OH)D levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism.


Options:
A: EASI score (1 month); Investigator Global Assessment (IGA) (1 month)
B: Vitamin D plasma concentrations (12 months)
C: To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. (End of the study)
D: Serum 25-Hydroxyvitamin D [25(OH)D] Levels (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)
Brief Summary: This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.


Options:
A: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
B: Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke (Throughout study, approximately 4.5 years)
C: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)
D: Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) (From Randomization at Visit 3 up to the Final Visit (average of 162 days)); Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D (From Randomization at Visit 3 to Final Visit (up to 162 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Partnerships to Overcome Obesity Disparities in Hawaii
Brief Summary: The PILI 'Ohana CBPR partnership implemented a pilot study to determine whether a Family plus Community focused intervention will improve weight loss maintenance compared to Standard follow-up in overweight/obese Native Hawaiian (NH) and other Pacific People (PP) adults (\> 18 yr. old) after receiving a standard individual-focused behavioral intervention. The primary hypothesis was that overweight/obese NH and PP adults that undergo a combined family-focused plus community-focused intervention vs. a standard follow-up after receiving a standard individual-focused behavioral intervention will have significantly higher rates of weight loss maintenance.


Options:
A: Weight in kilograms (kg) (Baseline, 3-month follow-up, and 9-month follow-up); Physical functioning measured by a 6-minute walk test (Baseline, 3-month follow-up, and 9-month follow-up)
B: Self-Care Behaviors; Glycemic control (HbA1c); fitness
C: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)
D: Change in Dietary Intake (18 months); Change in Physical Activity (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®
Brief Summary: This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.


Options:
A: Renal function: estimated glomerular filtration rate (Week 60)
B: effect of linagliptin compared to placebo on basal production and release of nitric oxide (NO) from renal vasculature (Changes from baseline after 4 weeks of treatment with linagliptin and placebo)
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: Rate of loss of creatinine clearance (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled Study of Light Therapy for Antepartum Depression
Brief Summary: The purpose of this study is to determine whether morning bright light therapy is an effective treatment for major depression during pregnancy compared with low-intensity placebo light therapy, when administered 60 minutes daily for 5 weeks.


Options:
A: N/A
B: 17-item Hamilton Depression Rating Scale (8 weeks)
C: Beck Depression Inventory (6 - 8 weeks postpartum)
D: Change in depression ratings (HAMD, SIGH-ADS) (5 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound
Brief Summary: The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound \[IVUS\] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor.


Options:
A: Change from baseline in low density lipoprotein cholesterol after 12 weeks
B: Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion (before randomization & 9-12 months after randomization)
C: Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) (Baseline, 3 Months)
D: To assess whether EZE-statin combined therapy is more effective than statin alone to achieve the optimum lipid control (LDL-cholesterol < 70 mg/dl) in chronic proteinuric nephropathy. (at baseline and every 4 months after therapy start)

Answer: B