TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Care Unit(ICU)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission (Weakness and ICU Readmission Evaluation-WIRE)
Brief Summary: This study seeks to define the morbidity of critical care polyneuropathy and to confirm that this diagnosis is, in fact, independently associated with increased mortality. Secondary information regarding the reasons for ICU readmission in patients with weakness may help in formulating cogent discharge strategies for these patients. Measurement of weakness using handgrip strength may provide a useful surrogate marker for weakness that may be more easily and uniformly applied.

Primary hypothesis:

* The development of ICU-associated weakness is independently associated with excess attributable mortality.

Secondary hypothesis:

* The development of ICU-associated weakness is associated with an increased need for ICU readmission.
* Readmission to the ICU will be a result of the development of recurrent respiratory failure or insufficiency
* Handgrip strength testing will detect ICU-associated weakness with an equivalent sensitivity as the comprehensive bedside muscle strength exam.


Options:
A: The change in the distance walked by patients in 6 minutes (6 minute walk test) between recruitment to the study and 3 months post intensive care discharge (3 months)
B: Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) (Measured at Months 6 and 12)
C: Hospital mortality (during hospitalization)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Care Unit(ICU)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission (Weakness and ICU Readmission Evaluation-WIRE)
Brief Summary: This study seeks to define the morbidity of critical care polyneuropathy and to confirm that this diagnosis is, in fact, independently associated with increased mortality. Secondary information regarding the reasons for ICU readmission in patients with weakness may help in formulating cogent discharge strategies for these patients. Measurement of weakness using handgrip strength may provide a useful surrogate marker for weakness that may be more easily and uniformly applied.

Primary hypothesis:

* The development of ICU-associated weakness is independently associated with excess attributable mortality.

Secondary hypothesis:

* The development of ICU-associated weakness is associated with an increased need for ICU readmission.
* Readmission to the ICU will be a result of the development of recurrent respiratory failure or insufficiency
* Handgrip strength testing will detect ICU-associated weakness with an equivalent sensitivity as the comprehensive bedside muscle strength exam.


Options:
A: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
B: The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10 (1 month)
C: Hospital mortality (during hospitalization)
D: Length of stay in ICU and length of stay in the hospital. (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Care Unit(ICU)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission (Weakness and ICU Readmission Evaluation-WIRE)
Brief Summary: This study seeks to define the morbidity of critical care polyneuropathy and to confirm that this diagnosis is, in fact, independently associated with increased mortality. Secondary information regarding the reasons for ICU readmission in patients with weakness may help in formulating cogent discharge strategies for these patients. Measurement of weakness using handgrip strength may provide a useful surrogate marker for weakness that may be more easily and uniformly applied.

Primary hypothesis:

* The development of ICU-associated weakness is independently associated with excess attributable mortality.

Secondary hypothesis:

* The development of ICU-associated weakness is associated with an increased need for ICU readmission.
* Readmission to the ICU will be a result of the development of recurrent respiratory failure or insufficiency
* Handgrip strength testing will detect ICU-associated weakness with an equivalent sensitivity as the comprehensive bedside muscle strength exam.


Options:
A: Diagnosis of CIPNM (June 2009)
B: Hospital mortality (during hospitalization)
C: Reduction in the decline of muscle force during the exacerbation. (discharge Day 9)
D: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)
Brief Summary: The purpose of the HOPE-2 study is to determine whether long term supplementation with folic acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease and/or diabetes mellitus.


Options:
A: Composite of all cause death, non-fatal acute myocardial infarction, acute hospitalization for unstable angina pectoris, and of non-fatal thromboembolic stroke (infarction) (During follow-up, 1.5-5 years)
B: Cardiovascular disease; Cancer
C: The composite of cardiovascular death, myocardial infarction (MI) and stroke
D: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)
Brief Summary: The purpose of the HOPE-2 study is to determine whether long term supplementation with folic acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease and/or diabetes mellitus.


Options:
A: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)
B: N/A
C: Common carotid artery intima media thickness; Brachial artery flow mediated vasodilatation
D: The composite of cardiovascular death, myocardial infarction (MI) and stroke

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)
Brief Summary: The purpose of the HOPE-2 study is to determine whether long term supplementation with folic acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease and/or diabetes mellitus.


Options:
A: The composite of cardiovascular death, myocardial infarction (MI) and stroke
B: Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke (Randomization up to 12 months); Participants With Any Major Bleeding Event (First dosing up to 12 months)
C: The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks. (12 weeks)
D: Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 (90 days post cardiac surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)
Brief Summary: The purpose of the HOPE-2 study is to determine whether long term supplementation with folic acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease and/or diabetes mellitus.


Options:
A: The composite of cardiovascular death, myocardial infarction (MI) and stroke
B: Change in urinary excretion of: - Kidney injury molecule-1 (KIM-1) - Albumin (12 weeks)
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: The change in plasma phosphorus after 8 weeks of niacinamide versus placebo (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study)
Brief Summary: The purpose of the HOPE-2 study is to determine whether long term supplementation with folic acid, vitamins B6 and B12 aimed at homocyst(e)ine reduction reduces the rates of major fatal and nonfatal cardiovascular events in patients with established cardiovascular disease and/or diabetes mellitus.


Options:
A: The composite of cardiovascular death, myocardial infarction (MI) and stroke
B: The primary end point was a composite of; nonfatal myocardial infarction,; fatal myocardial infarction,; nonfatal stroke,; fatal stroke, and; sudden death attributed to coronary heart disease.
C: Cardiovascular disease; Cancer
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Alzheimer's Disease Neuroimaging Initiative
Brief Summary: The purpose of this study is to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). This information will aid future clinical trials by providing a standard assessment tool to measure the effects of treatments being studied.


Options:
A: Cognitive state evaluated through Mini-Mental State Examination (Pre-intervention); Change in cognitive state evaluated through Mini-Mental State Examination (6 months after the beginning of the intervention); Change in cognitive state evaluated through Mini-Mental State Examination (12 months after the beginning of the intervention); Cognitive performance evaluated through Montreal Cognitive Assessment (Pre-intervention); Change in cognitive performance evaluated through Montreal Cognitive Assessment (6 months after the beginning of the intervention); Change in cognitive performance evaluated through Montreal Cognitive Assessment (12 months after the beginning of the intervention)
B: Change from Baseline in the elderly participant's Cognition (Post-intervention assessment (week 13)); Change from Baseline in the elderly participant's Quality of Life (Post-intervention assessment (week 13)); Change from Baseline in the caregiver's overall health (Post-intervention assessment (week 13))
C: N/A
D: Change in cognition (person with dementia) (Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline); Change in quality of life (person with dementia) (Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline); Change in general health outcome (carer) (Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Alzheimer's Disease Neuroimaging Initiative
Brief Summary: The purpose of this study is to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). This information will aid future clinical trials by providing a standard assessment tool to measure the effects of treatments being studied.


Options:
A: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)
B: Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale. (Baseline, 6 months, 12 months)
C: N/A
D: Cognition measured according to ADAS-cog, MMSE scales

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Alzheimer's Disease Neuroimaging Initiative
Brief Summary: The purpose of this study is to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). This information will aid future clinical trials by providing a standard assessment tool to measure the effects of treatments being studied.


Options:
A: stride length by gait analysis with an optoelectronic system (VICON®) (3 months of treatment)
B: N/A
C: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. (6 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)
Brief Summary: The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease.


Options:
A: Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days. (0 to 365 days)
B: composite of major adverse clinical events including death, any stroke, and/or myocardial infarction at 30-days post-procedure (30-days post-procedure); The same 30-day composite of major adverse clinical events plus death and/or ipsilateral stroke between 31-days and 12-months post-procedure. (Between day 31 and 12-months post-procedure.)
C: Number of Participants With Procedural Success (30 Days)
D: Hierarchical Composite of Stroke, Myocardial Infarction, and Death (30-day post-procedure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)
Brief Summary: The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease.


Options:
A: Hierarchical Composite of Stroke, Myocardial Infarction, and Death (30-day post-procedure)
B: Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days. (0 to 365 days)
C: Stroke and death (4 years)
D: Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery. (First 24 hours after implantation of carotid stent)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth
Brief Summary: Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus. In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.


Options:
A: Grade 3 or higher adverse events attributable to the vaccine. Mild and moderate adverse event rates will also be tabulated (At Day 0 and throughout study); Cell-mediated immunologic response as measured by HIV-specific cytotoxic T-lymphocyte activity against viral antigens (At Day 0 and throughout study); Humoral immunologic response as measured by detection of binding antibody to vaccine antigens and by neutralizing antibody assay (At Day 0 and throughout study)
B: N/A
C: Sero-response to Hepatitis B Surface Antigen (Week 28)
D: Qualitative Seroresponsiveness to Hepatitis B Surface Antigen (Week (Wk) 28 (One month after the second immunization)); Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE)) (Week 12, Week 24, Week 28, Week 76); Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) (Week 12, Week 24, Week 28, Week 76)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hepatitis B Vaccination in Youth at Adolescent Trial Network Sites: Effectiveness of Two Strategies and Evaluation of Tools To be Used in Future HIV Prevention Trials.
Brief Summary: This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate immunogenicity of the products in this population, barriers to vaccine delivery, and factors which predict a diminished immune response. Since these youths are also potential candidates for future HIV vaccine trials, this study will also include preliminary assessment of youths' understanding of informed consent forms, and willingness to participate in a vaccine trial and return for multiple visits (including blood draws for immunologic assessment).


Options:
A: HIV-infected patients who seroconvert in the first two months after the last vaccination. Seroconversion is defined as antibodies AbHBs titers equal or above 10 mUI per ml. (two months after the last injection;week 28, month 18, month 30 and month 42)
B: Qualitative Seroresponsiveness to Hepatitis B Surface Antigen (Week (Wk) 28 (One month after the second immunization)); Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE)) (Week 12, Week 24, Week 28, Week 76); Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) (Week 12, Week 24, Week 28, Week 76)
C: Sero-response to Hepatitis B Surface Antigen (Week 28)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
Brief Summary: Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.


Options:
A: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline to end of week 8)
B: Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8 (Baseline, Week 8)
C: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (From Baseline to week 8)
D: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint (Baseline, Week 10)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
Brief Summary: Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.


Options:
A: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm (16 weeks and 68 weeks); Severity of suicidal ideation, level of depressive symptoms (16 weeks and 68 weeks)
B: N/A
C: Suicidal Ideation Questionnaire - JR (SIQ-JR) (Baseline, 6 weeks, 12 weels, 24 weeks); Beck Depression Inventory - II (BDI-II) (Baseline, 6 weeks, 12 weeks, 24 weeks); Scale for Suicidal Ideation (SSI) (baseline, 6 weeks, 12 weeks, 24 weeks)
D: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline to end of week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
Brief Summary: Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.


Options:
A: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline to end of week 8)
B: N/A
C: N/A
D: Relapse of depressive symptoms (Measured at Months 3 and 9)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Costs of Preventing Alcohol Problems in Older Adults
Brief Summary: Older adults become more sensitive to alcohol, and alcohol also interacts adversely with their common medical conditions and medications. The aim of Project SHARE (Senior Health and Alcohol Risk Education) is to see whether patient and provider education can decrease risky alcohol use and reduce health care costs in persons 60 years of age and older.


Options:
A: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
B: At-risk drinking at 6 month followup (6 months); At-risk drinking at 12 month followup (12 months)
C: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
D: Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization (Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months)

Answer: B