TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)
Brief Summary: The specific aims are to determine the incidence of medication errors related to antimicrobial prophylaxis for cardiovascular surgery, joint replacement surgery, and hysterectomies across a heterogeneous sample of hospitals; identify organizational and practitioner factors associated with error rates, and evaluate the effectiveness of a multifaceted intervention in reducing prophylaxis error rates compared to written feedback alone in a sample of 44 hospitals enrolled in the study using a rigorous group-randomized design.


Options:
A: Change in performance between hospitals in the intervention and hospitals in the control group on the proportion of prophylaxis administered within the recommended timeframes.
B: Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group) (half year after intervention); Costs of both Implementation strategies (half year after intervention)
C: functional gain as measured by motor FIM score (One year post team training intervention)
D: Proportion of patients treated appropriately with respect to lipid-lowering therapy within four months after lipid testing (Measured at 2 years); Rate of appropriate treatment among patients with high blood pressure (Measured at 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE)
Brief Summary: The specific aims are to determine the incidence of medication errors related to antimicrobial prophylaxis for cardiovascular surgery, joint replacement surgery, and hysterectomies across a heterogeneous sample of hospitals; identify organizational and practitioner factors associated with error rates, and evaluate the effectiveness of a multifaceted intervention in reducing prophylaxis error rates compared to written feedback alone in a sample of 44 hospitals enrolled in the study using a rigorous group-randomized design.


Options:
A: mortality/survival (28 day)
B: Change in performance between hospitals in the intervention and hospitals in the control group on the proportion of prophylaxis administered within the recommended timeframes.
C: 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)
D: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB)
Brief Summary: STOP-DUB is a multicenter randomized clinical trial that is assessing the efficacy and effectiveness of hysterectomy versus endometrial ablation (EA) for dysfunctional uterine bleeding (DUB) in women for whom medical management has not provided relief.


Options:
A: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms (Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7)
B: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms (during a time period of 90 days under treatment)
C: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) (Baseline MBL over 6 menstrual cycles)
D: Randomized trial: Impact of surgery on bleeding, pain,; fatigue, and major problem (symptom) leading the woman to seek treatment for her condition.; Observational study: changes over time in treatment selected, DUB-related symptoms, and quality of life.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose-Response of Gonadal Steroids and Bone Turnover in Older Men
Brief Summary: The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men.


Options:
A: Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX) (Baseline and 16 weeks)
B: Effects on "bad" cholesterol, LDL-C, after 12 weeks
C: Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients. CVR, humeral and carotid vasoreactivity will be measured in all patients at M0 and M3.
D: Effects on HDL-C and Triglycerides after 12 weeks; Safety after 12 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients who are undergoing surgery for stage I rectal cancer.


Options:
A: Recurrence free at 3 year follow-up (3 year)
B: Phase II (Feasibility study) Primary Outcome: Recruitment Rate (24 Months); Phase III Primary Outcome: Organ Preservation (30 Months from start day of (chemo)radiotherapy treatment.)
C: Local recurrence (2 years)
D: 3-Year Disease-free Survival (Up to 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SSRI Administration to Reduce Acute Stress Disorder Symptoms and Prevent Depression and Posttraumatic Stress Disorder in Physical Trauma Victims in the Medical Setting
Brief Summary: The purpose of this study is to examine the efficacy of escitalopram compared to placebo in reducing Acute Stress Disorder (ASD) symptoms and in preventing the emergence of Post-Traumatic Stress Disorder (PTSD) in patients with medical trauma who are at risk for the development of PTSD based on the presence of ASD symptoms.


Options:
A: The primary outcome is symptom severity at the end of the trial .This will be determined using the Clinician Administered PTSD Scale (CAPS), a scale with established reliability and good psychometric properties. (13 months)
B: Prevention of whiplash syndrome according to validated scales of pain and neck motion disability. (Six months following the motor vehicle accident.)
C: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH) (28 days)
D: Symptoms of Acute Stress Disorder; Symptoms of Posttraumatic Stress Disorder

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies (DAIT ICAC-02)
Brief Summary: The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating asthma symptoms when combined with existing asthma treatment guidelines than treatment using the guidelines alone.


Options:
A: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
B: Time to Treatment Failure (Measured in Days) (Measured during the 36-week treatment period)
C: symptom-free days (1 year time frame with visits every 3 months)
D: Change in FENO (2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies (DAIT ICAC-02)
Brief Summary: The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating asthma symptoms when combined with existing asthma treatment guidelines than treatment using the guidelines alone.


Options:
A: time to first moderate or severe asthma exacerbation. (24 weeks)
B: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
C: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
D: Subject's height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject's stadiometer height data

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies (DAIT ICAC-02)
Brief Summary: The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating asthma symptoms when combined with existing asthma treatment guidelines than treatment using the guidelines alone.


Options:
A: Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5]) (90 Day outcome period); Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4) (90 Day outcome period)
B: Maximum Number of Asthma Symptom Days (Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
C: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
D: Daily asthma symptom score

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose Escalation, Multicenter Study to Determine the Safety of Intravenous Ex-vivo Cultured Adult Human Mesenchymal Stem Cells (Provacel) Following Acute Myocardial Infarction
Brief Summary: The purpose of the study is to determine whether adult stem cells \[Provacel™(PUMP1)\] are safe and possibly effective in the treatment of acute myocardial infarction (heart attack).


Options:
A: Change in left ventricular ejection fraction (6 months)
B: Comparison of treatment adverse event rates between the 0.5, 1.6 and 5.0 million mesenchymal stem cells per kilogram dose cohorts and placebo groups. (6 months)
C: Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (One month post-catheterization)
D: Incidence of major adverse cardiac event (MACE) (MACE defined as: cardiac death, cardiac arrest, myocardial infarction, sustained ventricular arrhythmias, pulmonary edema, acute heart failure, unstable angina and major bleeding) (Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose Escalation, Multicenter Study to Determine the Safety of Intravenous Ex-vivo Cultured Adult Human Mesenchymal Stem Cells (Provacel) Following Acute Myocardial Infarction
Brief Summary: The purpose of the study is to determine whether adult stem cells \[Provacel™(PUMP1)\] are safe and possibly effective in the treatment of acute myocardial infarction (heart attack).


Options:
A: Absolute changes in global LVEF by SPECT (baseline and 6 months)
B: Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI (4 months)
C: Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year) (after 3 months and 1 year of treatment)
D: Comparison of treatment adverse event rates between the 0.5, 1.6 and 5.0 million mesenchymal stem cells per kilogram dose cohorts and placebo groups. (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis
Brief Summary: The purpose of this study is to see which of the two most common drugs used to treat bronchiolitis works better. A child's participation in this study is expected to last less than 4 hours. Approximately 600 patients will be recruited to participate in this study at Kern Medical Center (KMC).

Bronchiolitis is a very common lung infection in babies. There are many drugs used to treat this disease but nobody knows which one, if any, works the best. Two of the most commonly used drugs are albuterol and epinephrine. These are both drugs given during breathing treatments with oxygen and a mask. We are doing this study to see which of these drugs works better or if they are both equally good. The study works as follows: after the consent process the baby gets three treatments.

* Nebulizer 1 (Treatment)
* Treatment + 30 minutes (approximately) Nebulizer 2
* Treatment + 60 minutes (approximately) Nebulizer 3
* Treatment + 120 minutes (approximately)

The baby will be reevaluated and either discharged home or revert to standard therapy. If the baby is discharged directly from the emergency department (E.D.), we will call you in three days time to see how he/she is doing.


Options:
A: Respiratory Assessment Change Score (RACS) (Baseline and 1 hour)
B: Successful hospital discharge at three days
C: respiratory clinical score; computerized quantification of wheezing and crackles
D: Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes (240 Minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Biologic Response of Menopausal Women to 17B-Estradiol
Brief Summary: The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the progression of early (subclinical) atherosclerosis and cognitive decline in healthy postmenopausal women.


Options:
A: Changes in cognition and brain metabolism (Baseline and 24 months)
B: Rate of change of carotid intimal medial thickness by ultrasound (Measured at screening, 12, 24, 36, and 48 months)
C: N/A
D: Progression of Subclinical Atherosclerosis (Baseline x 2 and then every 6 months up to 6.7 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)
Brief Summary: SCOT is a clinical research study designed for people with severe forms of scleroderma. SCOT stands for Scleroderma: Cyclophosphamide Or Transplantation. The SCOT study will compare the potential benefits of stem cell transplant and high-dose monthly cyclophosphamide (Cytoxan) in the treatment of scleroderma.


Options:
A: Forced Vital Capacity (12 months)
B: Global Rank Composite Score (GRCS) (Month 54, ITT) (54 Months Post-Randomization)
C: Time to Treatment Failure (12 months); Disease Improvement (12 months)
D: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value (Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing the Ambiance During Mealtimes in Dutch Nursing Homes
Brief Summary: Optimizing the social and physical ambiance during mealtimes in Dutch nursing homes: implementation and evaluation of the effect with respect to quality of life, nutritional status and physical performance.


Options:
A: mean dietary intake of inpatients during a 24 hour period (end of year 1 and year 2)
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: Assessment of nutritional status with the Mini nutritional Assessment (MNA) (Baseline and every 4 weeks, up to 24 weeks)
D: Nutritional status; Quality of life; Physical performance

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study Comparing Docetaxel Followed by Cyclophosphamide, Epirubicin and 5-FU to Docetaxel With Capecitabine Followed by Cyclophosphamide, Epirubicin and Capecitabine as Adjuvant Treatment for Early Breast Cancer
Brief Summary: This study compares two chemotherapy regimens as adjuvant treatment for breast cancer. The study participants are randomly allocated to receive either 3 cycles of docetaxel followed by 3 cycles of CEF (cyclophosphamide, epirubicin and 5-fluorouracil) or to receive 3 cycles of docetaxel plus capecitabine followed by 3 cycles of CEX (cyclophosphamide, epirubicin and capecitabine). The study participants are required to to have a medium to high risk for breast cancer recurrence. The primary aim of the study is to investigate whether addition of capecitabine to a standard taxane/anthracycline regimen will influence recurrence-free survival.


Options:
A: Pathologic complete response
B: Recurrence-free survival
C: Rate of pathological complete remissions (20 weeks)
D: Number of Participants With Disease-free Survival (DFS) Event (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery
Brief Summary: The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).


Options:
A: The evaluation of the degree of ST-segment resolution after the mechanical intervention. (90 minutes after last balloon inflation); The cumulative rate of death for any cause, reinfarction and target vessel revascularisation (8 months)
B: Target Lesion Failure (6 and 12 months)
C: Primary Clinical Endpoint of 12-Month Binary MACCE. (12 months post enrollment); 12-month Composite Safety Endpoint. (12 months after enrollment); Repeat Revascularization (PCI and/or CABG). (12 Months post enrollment)
D: Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year. (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Estrogen in the Prevention of Atherosclerosis Trial
Brief Summary: The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD).


Options:
A: N/A
B: Fracture; Bone mineral density
C: rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Estrogen in the Prevention of Atherosclerosis Trial
Brief Summary: The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD).


Options:
A: rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
B: Global disease activity throughout the follow-up period, estimated as the area under the SLEDAI-curve
C: N/A
D: Rate of change of carotid intimal medial thickness by ultrasound (Measured at screening, 12, 24, 36, and 48 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Loss - Louisiana Obese Subjects Study
Brief Summary: LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity (body mass index \[BMI\] 40-60 kg/m2). The intensive medical treatment is designed to produce 25% weight loss from baseline and to maintain at least 20% weight loss from baseline. The intensive medical treatment is compared to a usual care treatment model where individuals utilize self directed approaches to weight loss. The active treatment period is three years, followed by two years of observation.


Options:
A: Weight loss at 6 months
B: Body Weight (1 year)
C: Percent Change From Baseline Weight (Baseline, 2 years)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Loss - Louisiana Obese Subjects Study
Brief Summary: LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity (body mass index \[BMI\] 40-60 kg/m2). The intensive medical treatment is designed to produce 25% weight loss from baseline and to maintain at least 20% weight loss from baseline. The intensive medical treatment is compared to a usual care treatment model where individuals utilize self directed approaches to weight loss. The active treatment period is three years, followed by two years of observation.


Options:
A: Change in screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling (Baseline and 1 Year)
B: Number of weight management visits/ practitioner Full Time Equivalent(FTE) (Data will be collected monthly and analyzed at 6, 12 and 18 Months); Change in BMI (3,6,12,and 18 month where possible); Change in Self-reported health measures-SF12 (3,6,12 months and 18 months where possible)
C: Percent Change From Baseline Weight (Baseline, 2 years)
D: Change in BMIz score (Baseline to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Brief Summary: The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.


Options:
A: Incidence of adverse events (throughout study)
B: Proportion of Patients With Major Erythroid Response (MER) (Assessed after completion of 16 weeks of treatment)
C: Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
D: Progression-free Survival (PFS) Rate at 3 Years (Assessed every 3 months until progression up to 4 years and 8 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Brief Summary: The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.


Options:
A: Incidence of adverse events (throughout study)
B: Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
C: Occurrences of red blood cell transfusion (from study day 29 (week 5) to week 17)
D: Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP) (from week 5 to EOTP)

Answer: A