TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Different Doses and Schedules of Administration of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
Brief Summary: Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes lifelong disablement from a painful leg. The clinical consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.A variety of medical therapies have been investigated for patients with PAOD. There is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers.

Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe PAOD


Options:
A: Primary efficacy parameter: ulcer healing.; Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.
B: Time to major amputation of the treated leg or death from any cause, whichever comes first (From randomization up to 12 months)
C: evaluate the efficacy and the safety of NV1FGF compared to placebo in patients with severe PAOD.
D: Tissue perfusion as measured by TcPO2 (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood: Interventional Trial in the COPSAC2010 (Copenhagen Studies on Asthma in Childhood) Birth Cohort
Brief Summary: The aim of this study is to prevent asthma and allergies in childhood by supplementation with fish oil (n-3 fatty acids) to the mother during pregnancy. Paticipants are mother and children participating in the ABC-(Asthma Begins in Childhood)cohort. Mothers are recruited during pregnancy and receive supplement with n-3 fatty acids or olive oil (placebo) from week 24 of gestation to 1 week after delivery. The child is followed with acute and planned visit at the research unit and diagnosis of disease is done in the research unit according to predefined algorithms.


Options:
A: Weight, length and Rohrer index at birth, and gestational duration in single pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)
B: Vitamin D plasma concentrations (12 months)
C: Persistent wheeze 0 to 3 years of age (3 years)
D: Serum 25-hydroxyvitamin D concentration (Maternal: during 3rd trimester; Neonatal (cord blood))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood: Interventional Trial in the COPSAC2010 (Copenhagen Studies on Asthma in Childhood) Birth Cohort
Brief Summary: The aim of this study is to prevent asthma and allergies in childhood by supplementation with fish oil (n-3 fatty acids) to the mother during pregnancy. Paticipants are mother and children participating in the ABC-(Asthma Begins in Childhood)cohort. Mothers are recruited during pregnancy and receive supplement with n-3 fatty acids or olive oil (placebo) from week 24 of gestation to 1 week after delivery. The child is followed with acute and planned visit at the research unit and diagnosis of disease is done in the research unit according to predefined algorithms.


Options:
A: Insulin sensitivity (Measured at approximately Month 3)
B: Birth size (1 year)
C: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
D: Persistent wheeze 0 to 3 years of age (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion.
Brief Summary: This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.


Options:
A: Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28 (Day 28)
B: Visual Acuity (ETDRS Letters) (Visual acuity at 12 months)
C: The primary outcome of the study is the mean difference between treatment groups in the Early Treatment Diabetic Retinopathy Study (ETDRS) distance visual acuity score. (6 months post surgery)
D: Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28. (Day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Week, Multi-Centre Trial, Comprising A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase Followed By A 12-Week Open-Label Phase, To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder.
Brief Summary: The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged \> 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.


Options:
A: Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 (Baseline and Week 12)
B: Change from baseline in maximum cystometric capacity (4 Weeks)
C: Change From Baseline in mean number of micturitions per 24 hours (12 weeks)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Argatroban Versus Lepirudin in Critically Ill Patients - A Randomized Double-blind Trial
Brief Summary: The purpose of this study is to test the hypotheses that argatroban significantly increases efficacy and safety of renal replacement therapy measured as life time of haemodialysis filters as compared to lepirudin


Options:
A: Mean running time of a maximum of two consecutive haemodialysis circuits (seven days starting at time of HIT suspicion)
B: Time of insertion without complication
C: Circuit lifespan during continuous renal replacement therapy (up till termination as defined above) with each dialyzer (oXiris or M150) (usually 10 - 30 hours from commencement of circuit)
D: Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason) (up to 28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Argatroban Versus Lepirudin in Critically Ill Patients - A Randomized Double-blind Trial
Brief Summary: The purpose of this study is to test the hypotheses that argatroban significantly increases efficacy and safety of renal replacement therapy measured as life time of haemodialysis filters as compared to lepirudin


Options:
A: Time to Occurrence of Selected Prismaflex® System Alarms/Conditions (Up to 120 hours post CRRT treatment initiation)
B: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)
C: Mean running time of a maximum of two consecutive haemodialysis circuits (seven days starting at time of HIT suspicion)
D: the time of 1st membrane exchange (the time of 'filter is clotted')

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Argatroban Versus Lepirudin in Critically Ill Patients - A Randomized Double-blind Trial
Brief Summary: The purpose of this study is to test the hypotheses that argatroban significantly increases efficacy and safety of renal replacement therapy measured as life time of haemodialysis filters as compared to lepirudin


Options:
A: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
B: Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason) (up to 28 days)
C: The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting. (6 hours after starting dialysis)
D: Mean running time of a maximum of two consecutive haemodialysis circuits (seven days starting at time of HIT suspicion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (25 and 50 mg/Day) of DVS SR Tablets in Adult Outpatients With Major Depressive Disorder
Brief Summary: The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.


Options:
A: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation (Baseline and Week 8 or FOT)
B: Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 (At Baseline and Week 12.)
C: Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET) (Baseline and Week 8 (or ET))
D: Change of level of depression (Self-reported level of depressive symptoms measured by Beck Depression Inventory II) (0- 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection
Brief Summary: Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug treatment has improved the prognosis of persons with HIV infection, but is expensive and potentially toxic. Low micronutrient levels occur in the blood even in early stages of HIV infection and increase risk of a poorer prognosis, but the role of micronutrient and antioxidant supplements in medical management of HIV/AIDS is not well defined. The proposed clinical trial aims to assess if supplementation of untreated HIV-infected adults with a micronutrient and antioxidant preparation can delay decline in immunity or disease progression or start of anti-HIV drug treatment compared with supplementation with standard multivitamins. If the findings are positive, the study has implications for health and health care savings.


Options:
A: Weight Gain (18 months); Immune Reconstitution (18 months); Improved Quality of Life (18 months)
B: Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart), or emergence of documented CDC-defined AIDS-defining illness, or start of ART (Quarterly)
C: Change in Endothelial Function (Baseline and 12 weeks)
D: Development of a new or recurrent disease progression event, including all-cause death. (within 24 months after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of Percutaneous Transluminal Angioplasty (PTA) Versus a Supervised Exercise Programme (SEP) in the Management of Intermittent Claudication (IC) Due to Femoro-popliteal Disease
Brief Summary: Intermittent Claudication (IC)is a common condition characterised by pain in the muscles of the legs on exertion caused by "hardening of the arteries" and a reduced blood supply. The investigators know that the vast majority of people suffering from this condition remain stable and do not deteriorate, and thus in general the viability of legs is not at risk. The main aim of treatment, therefore, is to try and improve walking thus reducing the impact this problem has on patients life style. There are many methods of management of intermittent claudication, but the investigators do not know which produces the best results. This study aims to compare the short and medium term outcomes of exercise programmes, percutaneous transluminal angioplasty and a combination of the two treatments for patients with intermittent claudication.


Options:
A: maximum walking distance (one year)
B: Disease specific Quality of Life (12 months); Maximum Walking Distance (12 months)
C: Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD) (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment); Ankle brachial pressure indices(ABPI) measured at rest and post exercise (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment)
D: Health Related Quality of Life (HRQOL) (24 months with intermistic analysis at 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of Percutaneous Transluminal Angioplasty (PTA) Versus a Supervised Exercise Programme (SEP) in the Management of Intermittent Claudication (IC) Due to Femoro-popliteal Disease
Brief Summary: Intermittent Claudication (IC)is a common condition characterised by pain in the muscles of the legs on exertion caused by "hardening of the arteries" and a reduced blood supply. The investigators know that the vast majority of people suffering from this condition remain stable and do not deteriorate, and thus in general the viability of legs is not at risk. The main aim of treatment, therefore, is to try and improve walking thus reducing the impact this problem has on patients life style. There are many methods of management of intermittent claudication, but the investigators do not know which produces the best results. This study aims to compare the short and medium term outcomes of exercise programmes, percutaneous transluminal angioplasty and a combination of the two treatments for patients with intermittent claudication.


Options:
A: maximum walking distance (one year)
B: Combined outcome of ability to walk 400 m without the use of an assistive device or adjudicated evidence of inability to walk 400 m or death; Drop-in, drop-out, and loss to follow-up rates; Established Populations for Epidemiologic Studies of the Elderly (EPESE) physical performance score; 4 m gait speed; 400 m gait speed; Self-reported disability scale
C: Treadmill walking distances - Intermittent claudication distance(ICD),maximum walking distance(MWD) (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment); Ankle brachial pressure indices(ABPI) measured at rest and post exercise (Pretreatment, 1, 3, 6, 12, 36, & 60 months post treatment)
D: Maximal treadmill walking distance (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The ABC Study: A Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral, and Cognitive Effects of CONCERTA on Older Children With ADHD
Brief Summary: The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with attention deficit hyperactivity disorder (ADHD), when compared to placebo.


Options:
A: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose (Hour 4 post-dose)
B: Clinicians Manuals from Russell A. Barkley as Disruptive Behavior Disorders Rating Scale--Parent Form (Form 4), Disruptive Behavior Disorders Rating Scale--Teacher Form (Form 5) and Clinical Interview--Parent Report Form (Form 6) (1 year)
C: SKAMP deportment rating scale (Week 8)
D: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) (Hour 4 of the of the Lab School Day during Double-Blind Assessment Period); Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) (Hour 4 of the Lab School Day During the Double-Blind Assessment Period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The ABC Study: A Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral, and Cognitive Effects of CONCERTA on Older Children With ADHD
Brief Summary: The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with attention deficit hyperactivity disorder (ADHD), when compared to placebo.


Options:
A: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) (Hour 4 of the of the Lab School Day during Double-Blind Assessment Period); Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) (Hour 4 of the Lab School Day During the Double-Blind Assessment Period)
B: Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9). (12-hours from 8:00 am to 8:00 pm)
C: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6 (Baseline, Week 6)
D: Summed ADHD score of the ADHD-Rating Scale as rated by teachers (10 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Combination Therapy With Oseltamivir and Zanamivir Versus Monotherapy in the Treatment of Virologically Confirmed Influenza in Primary Care a Randomises Double Blind Controlled Trial Study
Brief Summary: In order to prevent the high mortality due to an hypothetic pandemic caused by a newly emerging influenza A virus, antiviral drugs are seen as essential requirements for control of initial influenza outbreaks.Two antivirals are available for the treatment oseltamivir and zanamivir. Emergence of Oseltamivir resistance has been recently reported. . It appeared opportune to assess the efficacy and safety of biotherapy of neuraminidase inhibitors ,will be investigated by a randomized, placebo controlled, double blind study in France, during the next winter season . This study will be conducted in 300 centres of primary care with 900 adults with a virologically suspected influenza A infection. Individuals will be randomized to 1 of the 3 treatment groups: oseltamivir +zanamivir, or oseltamivir+placebo or placebo +zanamivir.The primary judgment criteria will be the proportion of patients with negative RT PCR negative in nasal secretions at Day 2.


Options:
A: Least Squares (LS) Mean Change From Baseline to Week 16 in Hemoglobin (Hb) Level During the RCP (Baseline and Week 16)
B: Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 (Baseline, Week 48); Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48 (Baseline, Week 48)
C: RT-PCR for influenza A virus in nasal secretion (2 days)
D: Growth rate of geographic atrophy (GA) lesion area from baseline (Month 18)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
Brief Summary: This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.


Options:
A: Reduction in cardiac events (2)
B: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (minimum of one year)
C: Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events (One year)
D: Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events (From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
Brief Summary: Fluid resuscitation of severe sepsis may consist of natural or artificial colloids or crystalloids. There is no evidence-based support for one type of fluid over another.

The investigators hypothesis is that fluid resuscitation with Voluven® is advantageous to normal saline solution to improve sublingual microcirculation.


Options:
A: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization (until hemodynamic stabilization (up to 48 hours))
B: mortality rate at the 28th day after randomization, with a further control at 90th day. (mortality at 28th and 90th day after randomization)
C: 28 Day Survival (28 days from time of Emergency Department (ED) arrival)
D: Sublingual microcirculation (24 hour)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Saline Solution Versus Voluven®: A Controlled Study of Fluid Resuscitation in Severe Sepsis
Brief Summary: Fluid resuscitation of severe sepsis may consist of natural or artificial colloids or crystalloids. There is no evidence-based support for one type of fluid over another.

The investigators hypothesis is that fluid resuscitation with Voluven® is advantageous to normal saline solution to improve sublingual microcirculation.


Options:
A: Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization (until hemodynamic stabilization (up to 48 hours))
B: Mortality or dialysis-dependency (90 days)
C: Mortality; Quality of Life
D: Sublingual microcirculation (24 hour)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety Evaluation of 12-h and 2-h Urokinase Regimes in the Treatment of Pulmonary Thromboembolism: A Multi-Center, Randomized Controlled Trial in China
Brief Summary: Comparative trials of urokinase (UK) for 12 hours（UK-12h）or 24 hours (UK-24h) have produced similar results in acute pulmonary thromboembolism (PTE) thrombolysis. It is unclear whether the infusion time can be reduced further. The aim of this study was to investigate the efficacy and safety of weight adjusted dosage of UK-2h (20 000 IU/Kg) regime with the Uk-12h regime in selected patients with PTE in Chinese population.


Options:
A: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
B: The improvement of the right ventricular function , perfusion defect score on lung V/Q scans or quantitative computed tomographic pulmonary angiography (CTPA) score. (14d)
C: The improvement of the right hart function on echocardiograms (within the 1st 14 days); Perfusion defect score of lung V/Q scans (within the 1st 14 days); Quantitative computed tomographic pulmonary angiography (CTPA) score on 2d, 14d after treatment. (within the 1st 14 days)
D: Clinically relevant reduction of RVD (24 hours from Tenecteplase or Placebo injection)

Answer: B