TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab Versus Usual Care in Patients With Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk With Non-HDL-C Not Adequately Controlled With Maximally Tolerated Statin Therapy
Brief Summary: Primary Objective:

To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy.

Secondary Objectives:

* To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp\[a\]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein \[VLDL\], HDL, and intermediate-density lipoprotein \[IDL\] particle number).
* To assess changes in glycemic parameters with alirocumab vs. usual care treatment.
* To demonstrate the safety and tolerability of alirocumab.
* To evaluate treatment acceptance of alirocumab.
* To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development.
* To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).


Options:
A: Change From Baseline in Percent Atheroma Volume at Week 78 (Baseline and week 78)
B: Percent Change From Baseline in LDL-C at Week 52 (Baseline and Week 52)
C: Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
D: Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis (From Baseline to Week 24); Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum (From Baseline to Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye
Brief Summary: This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control.


Options:
A: Axial length (every 6 monthly in 2 years)
B: Axial Length of the Eye (Baseline and every 6 months post-baseline up to 18 months); Spherical Equivalent Refractive Error (Baseline and every 6 months up to 18 months)
C: Cycloplegic refraction (1 year)
D: Changes in uncorrected visual acuity (Baseline, Month 6, Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: GPS (Giving Parents Support): Parent Navigation After NICU Discharge
Brief Summary: BACKGROUND: Annually \>400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be classified as children with special health care needs (CSHCN) who will require health and related services of a type or amount beyond that required by children generally. NICU parents report increased anxiety and stress during their stay and transition home from the NICU. Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and depression for mothers, however, no studies have evaluated the effects of long term post-discharge peer support. Children's National (CN) provides medical home services to CSHCN through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents who provide peer emotional support, access to community resources, and assistance with navigating complicated health systems. NICU graduates and their caregivers may benefit from support provided by PNs after discharge. No data regarding the impact of PNs on patient and family outcomes of the NICU graduate are available.

OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety, depression; infant health care utilization, and immunization status.

METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and 12 months after discharge will be collected from caregivers in both groups including scales for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and immunization status. Outcomes will be compared at 12 months.

PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety, and depression; infant health care utilization and immunization status.

ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in the NICU can reduce anxiety and depression in caregivers. It is unclear whether peer support after discharge, when a family is faced with the total care of their child without structured supports, can significantly impact parents' ability to care for their child. The investigators anticipate that this simple intervention will increase self-efficacy in caregivers, reduce stress, anxiety, and depression, in turn resulting in improved health outcomes for their child.


Options:
A: Caregiver Burden Inventory (one year); Proportion of days spent at home by the AD patient in the past year (one year)
B: Parental Self-Efficacy (baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge)
C: Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) (3 months)
D: Depressive Symptoms (Change from baseline through study completion, an average of about 5 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Designing a Food Benefit Program to Optimize Diet Quality for Obesity Prevention
Brief Summary: This highly innovative experimental trial is designed to examine the independent and joint effects of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more healthful foods.


Options:
A: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))
B: Change in vegetable intake (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)); Change in vegetable liking (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)); Child self-regulation of energy intake (Measured at child age of 18 months); Change in child self-regulation of energy intake (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up))
C: BMI percentile at 3 years (3 years)
D: Change from baseline in Total Kilocalorie intake at 16 weeks (16 weeks); Change from baseline in reported levels of household food security at 16 weeks (16 weeks); Change from baseline in Healthy Eating Index (HEI) Score at 16 weeks (16 weeks); Change from baseline in daily servings of fruits and vegetable (added together) at 16 weeks (16 weeks); Change from baseline in daily total, in grams, of added sugars at 16 weeks (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Designing a Food Benefit Program to Optimize Diet Quality for Obesity Prevention
Brief Summary: This highly innovative experimental trial is designed to examine the independent and joint effects of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more healthful foods.


Options:
A: N/A
B: Body Mass Index Z-score (0, 6, 12, and 18 months)
C: Body mass index (6 month change)
D: Change from baseline in Total Kilocalorie intake at 16 weeks (16 weeks); Change from baseline in reported levels of household food security at 16 weeks (16 weeks); Change from baseline in Healthy Eating Index (HEI) Score at 16 weeks (16 weeks); Change from baseline in daily servings of fruits and vegetable (added together) at 16 weeks (16 weeks); Change from baseline in daily total, in grams, of added sugars at 16 weeks (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Adult Individuals With Corrected Tetralogy of Fallot
Brief Summary: In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups.


Options:
A: Cardiac disease knowledge (12 months)
B: Change of maximal oxygen uptake during exercise, measured in ml/kg/min (3 months)
C: Change in aerobic exercise capacity (peak VO2) (Baseline to 3 months (primary))
D: Cardiac MRI Right Ventricular Ejection Fraction (6 and 12 months); Cardiopulmonary exercise capacity (6 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Uncut Roux-en-Y Gastrojejunostomy on Quality of Life After Laparoscopic Distal Gastrectomy for Early Gastric Cancer Patients
Brief Summary: The current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our centre. Our previous results showed that this operation had a low postoperative complication and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe procedure. However, some limitations are noticed. The report from South Korea is a retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to improve QOL of patients after laparoscopic distal gastrectomy.


Options:
A: the incidence of Roux stasis syndrome (3 month after surgery)
B: Quality of life (one year)
C: Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis (0-5 years)
D: Effects of quality of life (The quality of life questionnaire was conducted at six months after surgery.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Technology Assisted Cascade Training and Supervision of Community Health Workers in Delivering Thinking Healthy Program for Perinatal Depression in a Post-conflict Area of Pakistan- Protocol of a Randomized Controlled Trial
Brief Summary: The Thinking Healthy Program is evidence based psychological intervention, delivered by non-specialists, with proven impact on maternal depression. A major challenge in the scale-up of this intervention, especially where health systems are weak, is providing quality training and supervision at scale. Women living in post-conflict areas are at a higher risk of depression than the general population.The key innovation proposed is the development and evaluation of a technology-assisted cascade training and supervision system to assist scale-up of the Thinking Healthy Programme in a post conflict area of Pakistan.


Options:
A: Depression (6 Months)
B: Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors (24-months post-intervention)
C: Competency of health workers in THP skills measured using ENact assessment tool (Immediately after intervention)
D: Viral load suppression (12 months); Patient Health Questionnaire 9 (PHQ-9) response (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Retrograde Intrarenal Surgery (RIRS) Versus Extracorporeal Shock Waves Lithotripsy (ESWL) for the Treatment of Renal Stones Measuring 6-20 mm: A Prospective Randomized Study
Brief Summary: To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20 mm size.


Options:
A: Number of patients stone free SFR 4 (1 month from treatment)
B: SFR (3 month)
C: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)
D: Analgesic demand (Postoperative 24 hours); Stone clearance (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Pilates Method in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence: : a Randomized Control Trial
Brief Summary: The purpose of this study is to compare the efficacy between a Pilates exercise program and a Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES) in muscular pressure strength of the pelvic floor as conservative treatment of urinary incontinence after prostatectomy.


Options:
A: Amount of Urinary Leakage (Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment); Frequency of Daily Urinary Leakage (Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment)
B: improves muscle strength of the pelvic floor at 3 months (baseline and 3 months)
C: urinary incontinence (august/2013 to December/2013 (4 months))
D: Effects of transcutaneous perineal stimulation compared to anal stimulation (Baseline, 6 and 10 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Intravenous Low Dose Versus High Dose Cyclophosphamide as Induction Therapy in the Treatment of Proliferative Lupus Nephritis
Brief Summary: This study will be conducted to find out whether low dose or high dose cyclophosphamide therapy is effective in the treatment of proliferative lupus nephritis.It will also compare the side effects and risks of infection in low dose and high dose cyclophosphamide group. Half of the participants will receive a low dose cyclophosphamide for 3 months and half will receive high dose cyclophosphamide therapy monthly for 6 months followed by azathioprine 2 mg/kg.


Options:
A: N/A
B: Assessment of Primary Renal Response (12 months)
C: Number of patients with reduction in proteinuria (measurement of total urine protein greater than 0.5 g/24-hours, or a urine protein to creatinine ratio greater than 0.5 mg/mg) (Baseline to Week 24)
D: Remission rate (2006-2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention to Promote Medical Students Empathy, Well-being and Study emotion-a Randomized Clinical Trial.
Brief Summary: The doctor-patient relationship was becoming worse. More and more work-related violence has happened to physicians and nurses. A portion of medical students felt depressed and thought that the career future was gloomy. The study was designed to measure the empathy, an vital element of professionalism, well-being of mental and study emotion. Furthermore, the investigators explored an intervention of group study to promote medical students' professionalism, mental health and study emotion.


Options:
A: Appetitive aggression (sumscore; 0-60 indicating higher levels) (Change from baseline to 3-5 and 6-9 months post treatment); Current violent behavior (sumscore; 0-96 indicating more acts) (Change from baseline to 3-5 and 6-9 months post treatment)
B: Medical students' empathy (3 months)
C: The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum (Baseline and 12 and 24-week postpartum follow-up)
D: Assessment of maternal depression (6 weeks); Assessment of maternal depression (Assessment of maternal depression at 6 months); Assessment of maternal sense of competence (6 weeks); Assessment of maternal sense of competence (Assessment of maternal sense of competence at 12 months); Assessment of mother infant bonding (6 weeks); Assessment of mother infant interaction (6 months); Assessment of newborn behaviour (6 weeks); Assessment of infant temperament (6 months); Assessment of infant temperament (Assessment of infant temperament at 12 months); Assessment of cognitive function by Bayley scale (6 months); Assessment of cognitive function by Bayley scale (Assessment of cognitive function by Bayley scale at 12 months); Assessment of home environment by PROCESS (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Scleroligation is a Safe and Effective New Technique for Eradication of Gastroesophageal Varices.
Brief Summary: Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation are very effective in controlling acute esophageal varices bleeding and preventing rebleeding.


Options:
A: Renal function (6 days)
B: Treatment failure (5 days)
C: Number of sessions to complete variceal obliteration (1 year)
D: Combined: bleeding + absence of severe adverse events + survival (15 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Efficacy and Safety Between Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to compare the effect of fosinopril plus benidipine vs. fosinopril plus hydrochlorothiazide on the renal function during the 6-month treatment in CKD patients with HTN.


Options:
A: N/A
B: Change from baseline diastolic blood pressure after 8 weeks; Change from baseline systolic blood pressure after 8 weeks
C: Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). (baseline to 12 weeks)
D: Changes in estimated glomerular filtration rate (Changes in eGFR at month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Efficacy and Safety Between Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to compare the effect of fosinopril plus benidipine vs. fosinopril plus hydrochlorothiazide on the renal function during the 6-month treatment in CKD patients with HTN.


Options:
A: Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death (At least 3 years of mean follow up period)
B: Changes in estimated glomerular filtration rate (Changes in eGFR at month 6)
C: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
D: Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). (baseline to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Double-blind, Randomized, Placebo-controlled, Descending Age, Dose-escalation Study of the Safety, and Immunogenicity of the Trivalent P2-VP8 Subunit Rotavirus Vaccine in Healthy South African Adults, Toddlers and Infants
Brief Summary: This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study examined the safety and immunogenicity of three dose levels of this vaccine in healthy South African adults, toddlers and infants. Progression from one dose level to another and to the next age group population was based on the assessment of safety information from the lowest dose and older age group.

The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated. The primary immunogenicity hypothesis is that the trivalent P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response to at least 2 of the 3 strains in 60% or more of participants in at least one of the study groups.


Options:
A: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies (8 weeks post vaccination); Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG) (8 weeks post vaccination)
B: Primary study endpoint: acute rotavirus diarrhoea occurring from 6 weeks of age to the end of the follow-up period in subjects who resided in randomized villages during the period when they were age-eligible to have received Rotarix. (24 months)
C: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)
D: Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination (Up to 28 days after any vaccination (up to Day 28 for toddlers and up to Day 84 for infants and adults)); Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination (7 days following each vaccination); Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen (Day 84); Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen (Day 84); Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain (Day 84); Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen (Baseline and Days 56 (pre-vaccination) and 84); Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen (Baseline and Days 56 (pre-vaccination) and 84); Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants (Baseline and Days 56 (pre-vaccination) and 84)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
Brief Summary: Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life


Options:
A: Growth velocity of formula regimen 1 and 2 versus WHO growth curve (0-6 months); Growth velocity (g/day) of formula regimen 1 and 2 versus a human milk (HM)-fed comparator group (0-6 months)
B: Mean weight gain (3 years); Mean weight gain (5 years)
C: Mean weight gain (6 months)
D: Analysis of IGF-1 value (4 months)

Answer: A