TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Trial of Hemodialysis Patient Aldosterone antagoniSm With Eplerenone Trial
Brief Summary: Forty percent of patients that require dialysis for kidney failure die within three years mostly due to heart disease. Heart failure and high blood pressure are common problems in patients that require dialysis and are key causes of death due to heart disease. Eplerenone is a drug that is very effective at improving heart failure and reducing blood pressure in patients that do not require dialysis. There is currently no evidence to tell physicians whether eplerenone would have similar benefits in patients that require dialysis. This evidence can only be reliably generated by performing a large scale study. Before such a study is undertaken, the investigators must determine whether eplerenone will be well tolerated and safe in patients that require dialysis. The investigators will perform an initial small trial called the Pilot trial in Hemodialysis patients undergoing Aldosterone antagoniSm with Eplerenone (PHASE) to determine if eplerenone is a well tolerated, safe medication to use in a very large, global study that will show whether or not eplerenone reduces important outcomes for patients like death from heart causes.


Options:
A: permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension (13 weeks)
B: residual renal function of peritoneal dialysis patients (From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.)
C: cardio- and cerebrovascular events
D: The time to onset of the first incident :non-fatal MI or acute coronary syndrome or hospitalization for heart failure or nonfatal stroke or cardiovascular (CV) death (25 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of the Probiotic Preparation VSL#3 on the Metabolic, Endocrine, Lipidomic and Inflammatory Parameters as Well as Variation of the Microbiota in Pediatric Patients With Body Mass Index >90°
Brief Summary: Obesity in children has become a significant social problem considering that nowadays 4 to 5 % of all children are obese in the industrialized countries with increased incidence in Europe by 10 to 50% over the past 10 years. Obesity is associated with the metabolic syndrome in 30% of the children and is considered as a state of chronic inflammation inducing the production of pro-inflammatory cytokines which determine metabolic and endocrine alterations on the organism. It has been observed that obesity is also linked to a change in the intestinal microflora with a reduction of Bacterioides and bifidobacteria and a decrease of Firmicutes and Staphylococcus aureus. The qualitative and quantitative analysis of the metabolites may provide us with a characterization of the existing phenotypes and variations in relation to the changes of the physiological state, in particular when supplemented or not with a probiotic preparation.


Options:
A: Biochemical: Number of Patients With Normal Transaminases at End of Treatment. (24 weeks); Physiological: Absolute Change in Liver Fat (Baseline and 24 weeks)
B: Liver Histology (Kleiner's et al Criteria, Hepatology 2005) (18 months)
C: Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS) (48 weeks)
D: Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90° (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of the Probiotic Preparation VSL#3 on the Metabolic, Endocrine, Lipidomic and Inflammatory Parameters as Well as Variation of the Microbiota in Pediatric Patients With Body Mass Index >90°
Brief Summary: Obesity in children has become a significant social problem considering that nowadays 4 to 5 % of all children are obese in the industrialized countries with increased incidence in Europe by 10 to 50% over the past 10 years. Obesity is associated with the metabolic syndrome in 30% of the children and is considered as a state of chronic inflammation inducing the production of pro-inflammatory cytokines which determine metabolic and endocrine alterations on the organism. It has been observed that obesity is also linked to a change in the intestinal microflora with a reduction of Bacterioides and bifidobacteria and a decrease of Firmicutes and Staphylococcus aureus. The qualitative and quantitative analysis of the metabolites may provide us with a characterization of the existing phenotypes and variations in relation to the changes of the physiological state, in particular when supplemented or not with a probiotic preparation.


Options:
A: Time To The First Breakthrough Overt HE Episode (Baseline up to 6 Months (168 days))
B: Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90° (1 year)
C: episodes of cholangitis (6 months after intervention)
D: High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk) (2 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis.
Brief Summary: Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon. Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early adulthood and lead to life-long substantial morbidity. There is no medical treatment available that meets the desired criteria of high efficacy versus low adverse effects. The current prevailing hypothesis regarding the cause of UC states that the pathogenesis involves an inappropriate and ongoing activation of the mucosal immune system driven by the intestinal microbiota in a genetically predisposed individual. Systematic investigation into the effect of correcting the dysbiosis in ulcerative colitis patients has never been performed. The most radical way to restore the presumably disturbed natural homeostasis in UC is to perform faecal transplantation from a healthy donor. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.

Endpoints are clinical remission and reduction of endoscopic inflammation after 12 weeks (primary), as well as time to recurrence, intra individual changes in faecal samples and mucosal biopsies. Follow up is 12 months.


Options:
A: co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score (at 12 weeks after treatment.)
B: Clinical Response (4 weeks following GMT Treatment)
C: The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks (Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.)
D: diversity and steady state of the stool (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis.
Brief Summary: Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon. Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early adulthood and lead to life-long substantial morbidity. There is no medical treatment available that meets the desired criteria of high efficacy versus low adverse effects. The current prevailing hypothesis regarding the cause of UC states that the pathogenesis involves an inappropriate and ongoing activation of the mucosal immune system driven by the intestinal microbiota in a genetically predisposed individual. Systematic investigation into the effect of correcting the dysbiosis in ulcerative colitis patients has never been performed. The most radical way to restore the presumably disturbed natural homeostasis in UC is to perform faecal transplantation from a healthy donor. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.

Endpoints are clinical remission and reduction of endoscopic inflammation after 12 weeks (primary), as well as time to recurrence, intra individual changes in faecal samples and mucosal biopsies. Follow up is 12 months.


Options:
A: Recurrence of CDI up to 8 Weeks (Up to Week 8)
B: Clinical Cure (8 weeks)
C: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
D: co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score (at 12 weeks after treatment.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Wellness for Young Men
Brief Summary: This study assesses the impact of a mindfulness-based stress reduction program compared with a health education program for urban middle-school male youth on outcomes of psychological symptoms, coping, stress, sleep, and behavior.


Options:
A: Adolescents' depressive symptoms by self-report (Measured at baseline, post-treatment, and 6-month follow-ups); Adolescents' symptoms of anxiety by self-report (Measured at baseline, post-treatment, and 6-month follow-ups); Adolescents' symptoms of depression and anxiety, including clinical levels of symptoms, as assessed by diagnostic interview (Measured at baseline and 6, 18, and 30-month follow-ups)
B: Depressive symptoms (Measured at Year 1)
C: use of Internet site (2 months)
D: psychological symptoms (6 months); coping (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of a Smartphone Application for Weight Loss in Primary Care
Brief Summary: BACKGROUND: The nascent field of mobile health (mHealth) is expanding with impressive speed. In March 2012, experts estimated that 40,000 health related smartphone applications were on the market but little is known about the effectiveness of these programs. To our knowledge, no studies have evaluated whether weight loss can be successfully achieved through use of a smartphone application or how these applications could be used in primary care practice.

PURPOSE: To evaluate the effectiveness of a popular, free smartphone application for weight loss and calorie counting in a primary care setting.

METHODS: The first phase of this study involved a community based participatory approach to select the intervention. Patient focus groups were conducted and analyzed to explore patients' preferences regarding various text-message versus smartphone programs. The second phase of this study, described here, will be a randomized controlled trial with overweight primary care patients exposed to one of two conditions for 6 months: (1) usual care; (2) usual care plus smartphone application, which includes instructing participants on how to use the application and encouraging them to use the applications' reminders and social networking features. The primary outcome of interest is weight change at 3 and 6 months. Two-sample t-test or Wilcoxon rank sum test will be used to compare weight change between groups, as appropriate. ANCOVA models will be used to examine weight change after adjusting for covariates such as education, sex and age. Repeated measures analysis will be carried out to compare weight change between the groups using baseline, 3 month and 6 month data. In addition to an intent-to-treat analysis, the investigators will also conduct a "treatment received" analysis, adjusting for the extent of application use in both the intervention and control arms.

CONCLUSIONS: This study will demonstrate whether a smartphone application introduced in primary care settings and incorporated into the visit can produce weight loss. Study findings could inform a national discourse on the value of smartphone applications in routine clinical practice.


Options:
A: Weight maintenance 12 months after weight loss intervention (15 months)
B: weight loss (six months)
C: Change in weight (12 weeks)
D: Change in weight at 6 months (baseline, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Brief Summary: This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.


Options:
A: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
B: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
C: changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). (0, 12, 24 months)
D: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Brief Summary: This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.


Options:
A: First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke
B: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
C: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
D: changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). (0, 12, 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Brief Summary: This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.


Options:
A: Cognitive Assessment: Trail Making Test Part B (Baseline-12 months); Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall (Baseline-12 months); Cognitive Assessment: Forward Digit Span Test (Baseline-12 months)
B: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
C: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
D: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Brief Summary: This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.


Options:
A: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
B: Pregnancy Loss or NICU Admission for Greater Than 48 Hours (6 weeks)
C: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
D: Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization (90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Brief Summary: This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.


Options:
A: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
B: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))
C: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
D: Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD (8-12 months after stroke onset)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Brief Summary: This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.


Options:
A: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
B: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a median of 3.5 years ] (From randomization; for approximately a median of 3.5 years)
C: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
D: the prevention of recurrent stroke. (Until the first recurrent stroke reaches a total of 339 between the two groups)

Answer: C