TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: High Prevalence of Rickets and Subclinical Maternal and Childhood Vitamin D Deficiency in the Middle East: a Randomized Controlled Trial of Prenatal Vitamin D Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Brief Summary: The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.


Options:
A: Change in T-cell cytokine expression (16-20 wks, 26-28 wks, and 36 wks gestation)
B: Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement (12, 16, 28 weeks and at maternal delivery and neonatal birth)
C: 25-hydroxyvitamin D concentration (6 scheduled timepoints during supplementation period); Serum calcium concentration (albumin-corrected) (6 scheduled timepoints during supplementation period); Urine calcium: creatinine ratio (7-8 scheduled timepoints during supplementation period)
D: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Brief Summary: The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer


Options:
A: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
B: Tolerability of regimen (4 weeks)
C: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
D: Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) (Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Brief Summary: The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer


Options:
A: Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) (Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred))
B: Tolerability of regimen (4 weeks)
C: 6 Month Progression-free Survival (PFS) (6 months); Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Up to 5 years); Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) (Up to 5 years)
D: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Therapy in the Treatment of Adolescent Anorexia Nervosa
Brief Summary: This study will compare the effectiveness of two different family treatments for the treatment of adolescent anorexia nervosa.


Options:
A: Diet Energy Density and Variety score (Measured before treatment and at Months 1, 2, 3, 4, 5, and 6)
B: Eating Disorder Interview (change from baseline to one month post-intervention); Eating Disorder Inventory (Change from baseline to one month post-intervention); Eating Disorder Interview (Change from baseline to 6 mos post-intervention); Eating Disorder Interview (Change from baseline to 12 months post-intervention); Eating Disorder Inventory (Change from baseline to 6 mos post-intervention); Eating Disorder Inventory (Change from baseline to 12 mos post-intervention)
C: Percent Ideal Body Weight (%IBW) (9-months and 21-months)
D: Scores on the Eating Disorders Examination (Measured at Year 1 of treatment and Year 1 of follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.
Brief Summary: To examine whether daily supplement of docosahexaenoic acid throughout the first year of life may speed up the achievement of gross motor development milestones in healthy infants, a total of 1160 healthy infants randomly allocated to receive throughout the first year of life daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3 (400 IU) alone. Primary outcome measure: time of achieving gross motor development milestones. Secondary outcome measure: time of achieving early fine motor development milestones and language.


Options:
A: plasma phospholipid fatty acid composition (28 days after intervention start); visually evoked potentials (48 weeks and 56 weeks postconceptional age)
B: Growth; Body composition; Intestinal microbiota; Blood pressure; Plasma lipid profile; Insulin - glucose; Erythrocyte fatty acid composition; Ex vivo cytokine production; IGF-1 and IGFBP-3; Adipokines; Plasma CRP; Plasma IgE
C: change of weight from day 30 to day 120 (postnatal age 30 to 120 days)
D: time of achieving the four gross motor development milestones (4, 8 and 12 months of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.
Brief Summary: To examine whether daily supplement of docosahexaenoic acid throughout the first year of life may speed up the achievement of gross motor development milestones in healthy infants, a total of 1160 healthy infants randomly allocated to receive throughout the first year of life daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3 (400 IU) alone. Primary outcome measure: time of achieving gross motor development milestones. Secondary outcome measure: time of achieving early fine motor development milestones and language.


Options:
A: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)
B: time of achieving the four gross motor development milestones (4, 8 and 12 months of age)
C: visual development
D: change of weight from day 30 to day 120 (postnatal age 30 to 120 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: 12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.
Brief Summary: To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder


Options:
A: N/A
B: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)
C: Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. (Baseline and Week 12)
D: The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
Brief Summary: The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be cocaine-free in the last 2 weeks of treatment.


Options:
A: Time to Treatment for Emerging Symptoms of a Mood Relapse (Up to 6 months)
B: Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine). (Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment))
C: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)
D: Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment. (Week 13)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Atorvastatin on the Occurrence of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
Brief Summary: The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.


Options:
A: Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control (3 days)
B: To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization) (30 days)
C: An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure (72 h)
D: the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG (in-hospital period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: PROlonging Dual Antiplatelet Treatment In Patients With Coronary Artery Disease After Graded Stent-induced Intimal Hyperplasia studY
Brief Summary: The duration of dual antiplatelet treatment (i.e. asprin and clopidogrel) after drug-eluting stent implantation is highly debated. This study will evaluate the value of extending such treatment up to 2 years after the procedure as compared to conventional treatment according to our national health institute guidelines (i.e. minimum 1 month after bare metal stent and 6 months after drug-eluting stent) on the composite endpoint of death, MI or stroke.


Options:
A: Cardiovascular events (five years)
B: Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke (From randomization to PACD, an average of 2.5 years)
C: Composite of death, myocardial infarction or stroke occurring in the time window from 31 days and up to 24 months after intervention. (24 months)
D: Occurrence of myocardial infarction,stroke or cardiovascular death.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PROlonging Dual Antiplatelet Treatment In Patients With Coronary Artery Disease After Graded Stent-induced Intimal Hyperplasia studY
Brief Summary: The duration of dual antiplatelet treatment (i.e. asprin and clopidogrel) after drug-eluting stent implantation is highly debated. This study will evaluate the value of extending such treatment up to 2 years after the procedure as compared to conventional treatment according to our national health institute guidelines (i.e. minimum 1 month after bare metal stent and 6 months after drug-eluting stent) on the composite endpoint of death, MI or stroke.


Options:
A: Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose (At 2 hours after first dose of study drug); Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug (4 to 72 Hours after last dose of study drug)
B: Occurrence of myocardial infarction,stroke or cardiovascular death.
C: Composite of death, myocardial infarction or stroke occurring in the time window from 31 days and up to 24 months after intervention. (24 months)
D: Primary Outcome The composite of cardio-vascular death, MI, stent thrombosis, TVR and bleeding (minor or major) following randomly assigned DES implantation (12 months after stent implantation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PROlonging Dual Antiplatelet Treatment In Patients With Coronary Artery Disease After Graded Stent-induced Intimal Hyperplasia studY
Brief Summary: The duration of dual antiplatelet treatment (i.e. asprin and clopidogrel) after drug-eluting stent implantation is highly debated. This study will evaluate the value of extending such treatment up to 2 years after the procedure as compared to conventional treatment according to our national health institute guidelines (i.e. minimum 1 month after bare metal stent and 6 months after drug-eluting stent) on the composite endpoint of death, MI or stroke.


Options:
A: Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year. (1 year)
B: Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA) (6 months)
C: Composite of death, myocardial infarction or stroke occurring in the time window from 31 days and up to 24 months after intervention. (24 months)
D: Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease
Brief Summary: Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease Rating Scale, Falls, muscle strength.


Options:
A: Falls rate (6 months post intervention)
B: Percentage of "Off" Time During Waking Hours at End of Study (22 weeks)
C: No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
D: Balance (3 time points)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease
Brief Summary: Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease Rating Scale, Falls, muscle strength.


Options:
A: Level of Physical Activity based on the LAPAQ questionnaire (Average of 6, 12, 18 and 24 months)
B: Balance (3 time points)
C: The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. (6 weeks)
D: Modified MACTAR scale (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-Managed Walking Improves Function in Patients With Diabetes Mellitus and Peripheral Arterial Disease
Brief Summary: We are conducting a clinical research trial to determine the role of self-managed walking therapy to improve walking ability in patients with diabetes mellitus and peripheral arterial disease (PAD). PAD, commonly referred to as poor circulation in the legs, is a very common disease in patients with diabetes mellitus. For patients with PAD, there is a significant risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy but the traditional methods for the delivery of this treatment have required frequent visits to a university or hospital-based site. We will address the role of self-managed walking program, to be conducted at or near the home, to improve limb function.


Options:
A: Attendance (12 months); Recruitment rate (12 months); Retention rate (12 months); The appropriateness and practicality of the designed intervention in the proposed settings (12 months); The acceptability of the intervention by participants and willingness to participate (12 months); The assessment rate of questionnaires (12 months); The appropriateness of statistical methods of data analysis (12 months); Likely required sample size for the future pilot trial (12 months); The effect size will be calculated for loneliness (12 months); The effect size will be calculated for social support (12 months); The effect size will be calculated for social networks (12 months); The effect size will be calculated for depression (12 months); The effect size will be calculated for anxiety (12 months); The effect size will be calculated for self-efficacy for exercise (12 months); The effect size will be calculated for satisfaction with level of social contacts (12 months); The effect size will be calculated for expected outcomes and barriers for exercise (12 months)
B: Maximal treadmill walking distance (6 months)
C: To reduce risk factors related to metabolic syndrome
D: Major Cardiometabolic Risk Factors: lipoproteins; Ectopic Fat (Visceral Fat, Liver fat); body composition (fat mass, lean body mass; and Insulin Sensitivity (Month 0, Month 4, Year 1, and Year 1 plus 2 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-Managed Walking Improves Function in Patients With Diabetes Mellitus and Peripheral Arterial Disease
Brief Summary: We are conducting a clinical research trial to determine the role of self-managed walking therapy to improve walking ability in patients with diabetes mellitus and peripheral arterial disease (PAD). PAD, commonly referred to as poor circulation in the legs, is a very common disease in patients with diabetes mellitus. For patients with PAD, there is a significant risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy but the traditional methods for the delivery of this treatment have required frequent visits to a university or hospital-based site. We will address the role of self-managed walking program, to be conducted at or near the home, to improve limb function.


Options:
A: Maximal treadmill walking distance (6 months)
B: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
C: Quality of Life (1 year)
D: maximum walking distance (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-Managed Walking Improves Function in Patients With Diabetes Mellitus and Peripheral Arterial Disease
Brief Summary: We are conducting a clinical research trial to determine the role of self-managed walking therapy to improve walking ability in patients with diabetes mellitus and peripheral arterial disease (PAD). PAD, commonly referred to as poor circulation in the legs, is a very common disease in patients with diabetes mellitus. For patients with PAD, there is a significant risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy but the traditional methods for the delivery of this treatment have required frequent visits to a university or hospital-based site. We will address the role of self-managed walking program, to be conducted at or near the home, to improve limb function.


Options:
A: Six-minute walk distance (Measured at baseline and follow-up study visits); Summary performance score (Measured at baseline and follow-up study visits)
B: Treadmill maximum walking distance (2 weeks); EACH-Q walking questionnaire score (2 weeks)
C: Maximal treadmill walking distance (6 months)
D: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Effect of Eszoplicone on Initial Continuous Positive Airway Pressure (CPAP) Compliance
Brief Summary: The purpose of this study is to assess the efficacy of Eszopiclone in improving short and intermediate-term compliance with continuous positive airway pressure (CPAP) in patients newly diagnosed with obstructive sleep apnea (OSA).


Options:
A: 24 h blood pressure (mean blood pressure; mmHg) (Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively)
B: Objective CPAP Use (12 months)
C: Short term CPAP Compliance (3 months); Intermediate CPAP Compliance (1 year)
D: Number of hours of use per day of CPAP (Six month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14-week, Randomized, Double-blind, Placebo-controlled, Multi-center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia
Brief Summary: This is a study to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.


Options:
A: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
B: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)
C: Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity (12 weeks after baseline (or last observation carried forward))
D: Change from baseline in the endpoint mean pain score (14 weeks); Fibromyalgia Impact Questionnaire (14 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Use of Fixed Doses of Artesunate Plus Amodiaquine Combination for the Home Management of Presumed Malaria in Malagasy Children
Brief Summary: The purpose of this study is to assess the feasibility, the acceptability and the effectiveness of the use of the Artesunate + Amodiaquine Fixed Dose Combination for the home management of presumed malaria in Malagasy children by the community-based service providers.


Options:
A: N/A
B: The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis (Two years)
C: Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age (15 months); Incidence of symptomatic P. falciparum malaria from 3 - 15 months of age (15 months); Incidence of symptomatic P. vivax malaria from 3-15 months of age (!5 months)
D: Assessment of the councils delivered by the community-based service provider to the parents or guardians of children and assessment of the observance of the treatment given by the parents or guardians. (one year)

Answer: D