TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Epinephrine and I.V. Needle on CPR Outcome
Brief Summary: Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.


Options:
A: Hospital Discharge (From time of first contact until hospital discharge, up to 90 days.)
B: Effective knowledge strategy (Two years)
C: Survival to Hospital Discharge. (at 30 days post arrest)
D: survival to hospital discharge with neurologic outcome (discharge from hospital)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease - a Randomized, Placebo Controlled, Double Blinded, Multicentre, Clinical Trial
Brief Summary: A growing body of evidence links Chlamydia pneumoniae to the progression of coronary heart disease. The purpose of this study is to determine the positive and negative effect of 14 days treatment with clarithromycin 500 mg daily in patients already suffering from stable coronary heart disease. The participants will be followed for at least two years after the treatment.

Abbott Laboratories supplied Clarithromycin and placebo tablets.


Options:
A: Composite consisting of: death regardless of cause; non-fatal AMI or; unstable angina pectoris whichever occurred first
B: Angiographic restenosis (6 months)
C: biochemical markers of brain ischemia and intraoperative cerebral oxymetry data (September 2010)
D: Reduction of LV dilation (six months versus baseline LV end-diastolic volume index by 2D-echocardiogram [echo]) more than 50% in the treated group in comparison to the placebo group (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease - a Randomized, Placebo Controlled, Double Blinded, Multicentre, Clinical Trial
Brief Summary: A growing body of evidence links Chlamydia pneumoniae to the progression of coronary heart disease. The purpose of this study is to determine the positive and negative effect of 14 days treatment with clarithromycin 500 mg daily in patients already suffering from stable coronary heart disease. The participants will be followed for at least two years after the treatment.

Abbott Laboratories supplied Clarithromycin and placebo tablets.


Options:
A: Comparison of number of participants with very good partial response or better response after three courses of VCD combined with clarithromycin or placebo (10 weeks)
B: Estimation of crude mortality by any reason of each study group; Estimation of attributable mortality by VAP of each study group; 7-day mortality rate of each group; 28-mortality rate of each group; Rate of progression to multiple organ failure and septic shock (and number of failing organs) of each study group; Time to progression to multiple organ failure and septic shock of each study group; Days of resolution of VAP; Days in ICU after diagnosis of VAP
C: Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations) (5 to 8 months)
D: Composite consisting of: death regardless of cause; non-fatal AMI or; unstable angina pectoris whichever occurred first

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Long-Term Extension Study to Assess the Safety and Efficacy of Etanercept in the Treatment of Psoriasis in Adult Subjects
Brief Summary: The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004. Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.


Options:
A: Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set) (16 weeks)
B: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
C: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
D: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Long-Term Extension Study to Assess the Safety and Efficacy of Etanercept in the Treatment of Psoriasis in Adult Subjects
Brief Summary: The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004. Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.


Options:
A: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
B: Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 (Week 16)
C: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 (Week 16); Number of Participants Experiencing Adverse Events (Up to 72 weeks); Number of Particpants Discontinuing Study Treatment Due to Adverse Events (Up to 52 weeks)
D: Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest (From Day 169 to Day 729); Short-term Period: Number of Participants With ACR 20 Response at Day 169 (At Day 169 from Baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Long-Term Extension Study to Assess the Safety and Efficacy of Etanercept in the Treatment of Psoriasis in Adult Subjects
Brief Summary: The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004. Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.


Options:
A: Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52. (Baseline, Week 52)
B: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)
C: Change in PASI score from baseline in the two groups (12 weeks)
D: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Long-Term Extension Study to Assess the Safety and Efficacy of Etanercept in the Treatment of Psoriasis in Adult Subjects
Brief Summary: The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004. Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.


Options:
A: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)
B: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)
C: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 (Week 12); Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12)
D: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Long-Term Extension Study to Assess the Safety and Efficacy of Etanercept in the Treatment of Psoriasis in Adult Subjects
Brief Summary: The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004. Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.


Options:
A: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)
B: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
C: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)
D: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Brief Summary: The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise


Options:
A: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); M/I (3-months after a medication washout)
B: Hemoglobin A1c (A1C) Changes From Baseline at Week 24 (Baseline, Week 24); A1C Changes From Baseline at Week 24 - Open Label Cohort (Baseline, Week 24)
C: Change from baseline in HbA1c at 24 weeks
D: Glycosylated Hemoglobin (HbA1c) Change From Baseline (Baseline, 52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Brief Summary: The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise


Options:
A: Hemoglobin A1c (A1C) Changes From Baseline at Week 24 (Baseline, Week 24); A1C Changes From Baseline at Week 24 - Open Label Cohort (Baseline, Week 24)
B: N/A
C: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)
D: HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment (Baseline and 24 weeks); HbA1c Change From Baseline in Patients With Mild Renal Impairment (Baseline and 24 weeks); HbA1c Change From Baseline in Patients With Moderate Renal Impairment (Baseline and 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"
Brief Summary: The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone


Options:
A: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 weeks)
B: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 (Week 24)
C: Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Baseline, Week 24)
D: Novel cardiovascular risk factors modification (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Guided Care: Integrating High Tech and High Touch
Brief Summary: The purpose of the study is to evaluate the effect of a Guided Care nurse on the quality of the health and well-being of the frail elderly. A specially trained registered nurse will work closely with 1-3 primary care physicians to provide the most complex older patients (and their unpaid caregivers) with health care that is comprehensive, coordinated, patient-centered, and proactive. The study will evaluate the effects of Guided Care on:

* older persons' physical and mental health, health services utilization, quality of care, self-efficacy, and satisfaction with care;
* older persons' unpaid caregivers' burden; and
* primary care physicians' satisfaction with their care of chronically ill patients.


Options:
A: New Advance Care Planning Documentation in the Medical Record at 9 Months (9 months after study enrollment)
B: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)
C: SF-36 Physical Health Summary Scale (Baseline, 6, 18, and 32 months); SF-36 Mental Health Summary Scale (Baseline, 6, 18, and 32 months); Health Services Utilization (Baseline, 8, 20, and 32 months)
D: Health Related Quality of Life according to EuroQoL (5 questions, 3 levels) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Comparing Docetaxel, Doxorubicin and Cyclophosphamide (TAC) vs 5-Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
Brief Summary: This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:

* TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
* FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.


Options:
A: N/A
B: Disease-free Survival (DFS) Events (10 years)
C: Disease-Free Survival (after 10 years follow up)
D: Disease-free Survival (up to 5.25 years (63 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine and Anger Management Groups for PTSD Veterans in the Hawaiian Islands
Brief Summary: Telemedicine has the potential to profoundly influence the delivery of specialized care to the remote veteran population suffering with PTSD. Preliminary research supports telemedicine technology as a possible solution to improve access to mental health services for veterans with PTSD. The proposed research is a treatment-outcome study that will assess the clinical efficacy of conducting an Anger Management Therapy (AMT) group treatment intervention using a videoteleconferencing (VTC) modality as compared to the traditional in-person modality with veterans who have PTSD and reside in remote locations on the Hawaiian Islands. AMT is a manual-guided cognitive-behavioral, skill based group intervention that has been used nationwide in VA substance abuse programs and most recently has been adopted by many VA PTSD Clinical Teams to treat anger-related to the sequelae of PTSD.


Options:
A: Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months (One year post-enrollment)
B: State-Trait Anger Inventory (STAXI-2) Anger Expression Index (Baseline); State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale (Post-treatment (2 weeks following last treatment session)); State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale (3-month Follow Up); State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale (6-month Follow Up); Novaco Anger Scale (NAS) (Baseline); Novaco Anger Scale (NAS) (Post-treatment (2 weeks following last treatment session)); Novaco Anger Scale (NAS) (3-Month Follow Up); Novaco Anger Scale (NAS) (6-Month Follow Up)
C: Reduction in systolic blood pressure taken by study team at home visit (12 months)
D: to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics (90 days); to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only (90 days); to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations (90 days); to assess the completeness of the data collection in telemedicine versus telephone-only consultations. (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Brief Summary: Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.


Options:
A: Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day (baseline to week 12); Mean Change the Severity of Moderate to Severe Vasomotor Symptoms (baseline to week 12 (12 weeks))
B: Mean change from baseline in number of daily moderate to severe hot flushes.; Mean change from baseline in daily hot flush severity.; Mean change from baseline in vulvovaginal atrophy symptoms.
C: To measure estrone, estradiol and estriol levels at baseline and after achieving a steady state with 15-days of administration of three commonly used doses of bioidentical compounded estrogen cream and a standard dose conventional estrogen patch. (Day 1 and Day 15); To measure the progesterone levels at baseline and after achieving a steady state with 15-days of administration of 100 mg/day of two different oral progesterone formulations. (Day 1 and Day 15)
D: Lowest effective dose in decreasing the frequency and severity of hot flushes

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Individual-based Diet and Physical Activity Intervention Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women
Brief Summary: Advancing age in itself is associated with changes in body composition. However, during transitional life stages, such as retirement, detrimental changes on diet and physical activity may occur. This might lead to weight gain and accumulation of abdominal fat.

To prevent these changes, participants receive a low-intensity intervention on energy balance and related behaviours.

After six months, one and two years, the effects will be studied by comparing the intervention group with the control group.


Options:
A: Change in Body Weight. (one year)
B: Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure); Energy intake (Food Frequency Questionnaire); Physical activity level (Physical Activity Scale for the Elderly)
C: N/A
D: Weight loss at 6 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial Regarding the Acceptability of an Audiotape Questionnaire for Intimate Partner Violence Screening in a Pediatric ED
Brief Summary: The purpose of this study is to compare the safety, acceptability and ease of the administration of two screening methods, a pen and paper questionnaire and an audiotape with headsets, for screening for intimate partner violence in a pediatric emergency department (ED).


Options:
A: Reduced child abuse and neglect (2002 - 2005)
B: HIV sero-incidence (24 months post-baseline)
C: disclosure rates for past year exposure to intimate partner violence
D: Acceptability, perceived safety and ease of administration of each survey method

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Brief Summary: The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.


Options:
A: Overall Survival Time (OS) (time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007)
B: 24-month Progression-free Survival (assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry)
C: rate of laryngeal preservation
D: Overall Survival (Percentage of Participants Alive) (From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.)

Answer: A