TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Artificial Kidney Initiation in Kidney Injury, a Multicenter Randomised Trial
Brief Summary: The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:

1. an "early" strategy where RRT is started immediately when a RIFLE F status is documented
2. a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration \> 40 mmol /L, serum potassium concentration \> 6 mmol /L, serum potassium concentration \> 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH \< 7.15 in the context of pure metabolic acidosis (PaCO2 \<35 mmHg) or in the context of mixed acidosis with PaCO2\> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow\> 5L/min in spontaneously breathing patients or FiO2\> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2\> 95%, despite diuretic therapy.

The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.


Options:
A: Feasibility of protocol adherence (14 days)
B: Overall survival (60 days)
C: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
D: We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints. (60 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double Blind Study to Compare the Efficacy Between Cilostazol and Aspirin on White Matter Changes by Cerebral Small Vessel Disease
Brief Summary: There may be a difference in efficacy of cilostazol and aspirin on progression of white matter changes in cerebral small vessel disease.


Options:
A: new silent brain infarctions (24 months)
B: The primary endpoint is death from any cause or incident, dementia or persistent physical disability. (every 6 months)
C: Volume of white matter changes (WMCs) (baseline, week 104)
D: Feasibility of Phase III Trial (36 months (24 Months Recruitment + 12 months Follow Up))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Smoking Cessation in the Homeless Population
Brief Summary: The goal of this research study is to enhance smoking cessation rates for homeless smokers. The original study design proposed to test the effects of 1) an Intensive Smoking Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will utilize a 3-group randomized design to test study hypotheses. The three study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A); 2) Intensive Smoking Intervention using CBT-(IS); or 3) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). Due to low enrollment because of the addition of an alcohol use screening criteria, the study was changed to a two arm study and the study time frame changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). The study length is reduced to 26 weeks from 52 weeks. All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge. Counseling will follows the protocol used in a recent study of alcohol dependent smokers and will include weekly individual sessions for 3 months followed by study data collection visits 3 months. Both study conditions will have equal number of study contacts. Study staff will make retention contacts with participants in the community during weeks that do not have study visits scheduled. Primary smoking outcome is cotinine-verified 7-day smoking abstinence at week 26 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 16, and 26. Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90 days at week 26. Recruitment and retention will be enhanced by use of gift cards, bus passes, other non-monetary incentives, attractive intervention materials, collaboration with homeless shelters, and advice from a Community Advisory Board. Participants will be enrolled from homeless shelters and facilities in the 7-county greater Minneapolis/St. Paul metro area. Our power calculation indicates that a sample size of 215 per study condition is needed to detect proposed treatment effects.


Options:
A: Three month point-prevalence abstinence from cigarettes (3 months post-intervention)
B: N/A
C: CO-verified Smoking Status at 26 Weeks (7-day smoking abstinence at week 26 follow-up)
D: 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Pregnancy Rate After Exercise Training Prior to Assisted Fertilisation in Overweight/Obese Women
Brief Summary: Overweight/obesity is associated with sub-fertility. The investigators will assess if regular exercise training prior to assisted fertilization will improve pregnancy rate in overweight/obese women referred to assisted fertilization. It is expected that training will be successful in increasing pregnancy rate


Options:
A: Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation (12 months)
B: Clinical Pregnancy Rate (up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle)
C: Pregnancy rate (7 weeks after assisted fertilisation)
D: Reduction in body weight (From baseline to 6 weeks postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients
Brief Summary: The purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients, families, and clinicians in the outpatient setting. We are testing a new way to help patients share their preferences for talking about end-of-life care with their clinicians and families. To do this we created a simple, short feedback form. The form is designed to help clinicians understand what patients would like to talk about. The goal of this research study is to show that using a feedback form is possible and can be helpful for patients and their families.


Options:
A: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)
B: PTSD Symptoms (Post-treatment, ten weeks); Depression Symptoms (Measured at Post-Treatment, at 10 weeks); State Anxiety (Measured at Post-Treatment, at 10 weeks)
C: Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS) (Change from Baseline at 3 months after intervention)
D: Quality of primary medical care (Measured over 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients
Brief Summary: The purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients, families, and clinicians in the outpatient setting. We are testing a new way to help patients share their preferences for talking about end-of-life care with their clinicians and families. To do this we created a simple, short feedback form. The form is designed to help clinicians understand what patients would like to talk about. The goal of this research study is to show that using a feedback form is possible and can be helpful for patients and their families.


Options:
A: Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale (Measured at enrollment and 2 weeks after targeted clinic visit)
B: Aim 1: feasibility and acceptability of learning Motivational Interviewing techniques by palliative care clinicians (Through study completion, an average of 1 year.)
C: Functional Assessment of Cancer Therapy (Quality of Life Measure) (12 weeks)
D: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients
Brief Summary: The purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients, families, and clinicians in the outpatient setting. We are testing a new way to help patients share their preferences for talking about end-of-life care with their clinicians and families. To do this we created a simple, short feedback form. The form is designed to help clinicians understand what patients would like to talk about. The goal of this research study is to show that using a feedback form is possible and can be helpful for patients and their families.


Options:
A: Total response rate for all 4 methods of delivery (120 to 240 days post index event)
B: Change in Depressive symptoms (3, 6 and 12 months.)
C: UWQOL v4 QoL (Post-Treatment 1 Year Review Clinic)
D: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open, Self-Controlled, Prospective Study of Concerta on Cognitive Functions, Efficacy and Tolerance in the Pediatric Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Brief Summary: The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder (ADHD).


Options:
A: Treatment emergent adverse events over 12 months. (Weekly)
B: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)
C: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose (Hour 4 post-dose)
D: Change From Baseline in Digit Span Test Total Score at Week 12 (Baseline and Week 12); Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1 (Baseline and Week 1); Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2 (Baseline and Week 2); Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3 (Baseline and Week 3); Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7 (Baseline and Week 7); Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12 (Baseline and Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
Brief Summary: Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when administered in adequate amounts, confer health benefit to the host.Based on this previous knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators conducted a prospective, multicenter, randomized and controlled trial to assess whether oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).


Options:
A: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
B: Probiotics Prevent Hirschsprung's Disease Associated Entercolitis (two years)
C: Time to reach full feeds (First 40 days after birth)
D: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). (6 months post-pullthrough); Severity of Clinical Episodes of HAEC (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Applicability and Outcome of Regular Exercise Training After Transcatheter Aortic Valve Implantation
Brief Summary: This pilot study will evaluate the effect of a rehabilitative exercise training on exercise capacity in patients after percutaneous aortic valve replacement. It will additionally evaluate the safety of such an approach and the effect on life quality. We hypothesize that regular structured exercise improves exercise capacity in these patients beyond the sole effect of the valve procedure.


Options:
A: Proportion of patients willing to undertake cardiac rehabilitation following TAVR. (6 months)
B: Change of peak oxygen uptake (Baseline to 8 weeks)
C: Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study (Randomized Controlled Trial - 24 months Continued Access Study - 12 months)
D: Change in physical capacity (1,4,12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation
Brief Summary: Optimal anticoagulation using heparin with close attention to maintain therapeutic dosing during the procedure is important.

Randomized comparison of continuous and intermittent heparin infusion during catheter ablation of Atrial Fibrillation.


Options:
A: 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)
B: therapeutic ACT retention rate during procedure (2 years)
C: Clinically significant hematoma (defined as hematoma requiring reoperation and/or transfusion and/or unplanned or prolonged hospitalization and/or interruption of LMWH or IV heparin or oral anti-coagulant. (Device implant until first routine post-op visit)
D: Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure. (Up to 6 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of Low Dose Primaquine for Clearance of Gametocytes in Asymptomatic Individuals Infected With P. Falciparum in Burkina Faso
Brief Summary: Primaquine (PQ) is currently the only available drug that can clear mature transmission stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist after artemisinin-combination therapy. However, there are safety concerns about the use of PQ at the currently recommended dose of 0.75mg/kg in individuals who are glucose-6-phosphate dehydrogenase (G6PD) deficient. PQ causes transient but significant haemolysis in G6PD deficient individuals; this side-effect is dose dependent. There are indications that a lower dosing of PQ may effectively reduce gametocyte carriage but the lowest efficacious dose for gametocyte clearance is currently unknown. Recently, the World Health Organization changed their recommendation to a low dose of primaquine, 0.25mg/kg. However, there is no direct evidence on the extent to which (low dose) PQ prevents malaria transmission to mosquitoes and what the lowest efficacious dose is.

In the current study we aim to identify the lowest efficacious dose of PQ in individuals with normal G6PD function. Children with asymptomatic malaria and normal G6PD enzyme function will be randomized to treatment with artemether-lumefantrine alone or in combination with low doses of PQ. All enrolled individuals will receive a full three-day course of AL, and will be randomized to receive a dose of primaquine or placebo with their fifth dose of AL. Efficacy will be determined based on gametocyte carriage during follow-up, measured by molecular methods. For a subset of participants with patent gametocytes, primaquine effect on infectivity to mosquitoes will be assessed by membrane feeding assays


Options:
A: Mean number of days to gametocyte clearance (gametocyte clearance time, GCT) (14 days); Mean (+/- SD) maximal fall in Hb (g/dL) from enrollment to day 28 of follow-up (28 days)
B: Gametocyte carriage (14 days during follow-up)
C: Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
D: Development of sexual stages of P.falciparum (42 days post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial
Brief Summary: The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV) incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. This randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.


Options:
A: Occlusion rate (One year after the treatment); Freedom from reflux (One year after the treatment); Disease-specific quality of life (One year after the treatment); Occlusion rate (three years after the treatment); Freedom from reflux (three years after the treatment); Disease-specific quality of life (three years after the treatment); Occlusion rate (five years after the treatment); Freedom from reflux (five years after the treatment); Disease-specific quality of life (five years after the treatment)
B: long-term QoL follow-up of patients after UGFS and surgical stripping (6-10 years follow-up)
C: Occlusion rate (up to 5 years)
D: Generic Quality of life - Short Form-36 (1 week, 6 weeks, 3 months, 1 year, 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack
Brief Summary: This study is being done to better understand how genetic information might improve assessment of heart attack risk.


Options:
A: Discussion between provider and patient about statin treatment (within 6 months of randomization)
B: Change in serum LDL-cholesterol level (at 6 months post disclosure of CAD risk)
C: Net Difference in Proportion Treated with Low-dose Diuretics (baseline and at one year)
D: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack
Brief Summary: This study is being done to better understand how genetic information might improve assessment of heart attack risk.


Options:
A: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
B: Change in serum LDL-cholesterol level (at 6 months post disclosure of CAD risk)
C: Change in Self-Reported Preference for Opioid Pain Reliever (Baseline and Immediate Post-test)
D: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Crossover Trial to Assess the Effects of Dairy Intake on Insulin Sensitivity and β-Cell Function in Men and Women at Risk for Diabetes Who Are Habitual Consumers of High Sugar Beverages
Brief Summary: The aim of this trial is to evaluate the effects of dairy product consumption on insulin sensitivity and pancreatic β-cell function in men and women at risk for the development of type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet sodas and fruit juice cocktails).


Options:
A: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)
B: Change in body weight from baseline (4 weeks)
C: Changes in the acute metabolic and hormonal response (glucose, insulin, leptin, active ghrelin, triglycerides, uric acid) (Baseline and 10 weeks); Changes in fat content of skeletal muscle and liver (Baseline and 10 weeks)
D: Matsuda Insulin Sensitivity Index (MISI) (6 weeks)

Answer: D