TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8-Week Multi-Center, Randomized, Double Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150mg-600mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Symptoms Of Neuropathic Pain
Brief Summary: The objective of this study is to evaluate the efficacy, safety and tolerability for pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the symptoms of neuropathic pain.


Options:
A: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Number of Responders (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline at Week 1 in Mean Weekly Pain Scores (From baseline to Week 1); Change From Baseline at Week 2 in Mean Weekly Pain Scores (From baseline to Week 2); Change From Baseline at Week 3 in Mean Weekly Pain Scores (From baseline to Week 3); Change From Baseline at Week 4 in Mean Weekly Pain Scores (From baseline to Week 4); Change From Baseline at Week 5 in Mean Weekly Pain Scores (From baseline to Week 5); Change From Baseline at Week 6 in Mean Weekly Pain Scores (From baseline to Week 6); Change From Baseline at Week 7 in Mean Weekly Pain Scores (From baseline to Week 7); Change From Baseline at Week 8 in Mean Weekly Pain Scores (From baseline to Week 8); Change From Baseline at Week 9 in Mean Weekly Pain Scores (From baseline to Week 9); Change From Baseline at Week 10 in Mean Weekly Pain Scores (From baseline to Week 10); Change From Baseline at Week 11 in Mean Weekly Pain Scores (From baseline to Week 11); Change From Baseline at Week 12 in Mean Weekly Pain Scores (From baseline to Week 12); Change From Baseline at Week 13 in Mean Weekly Pain Scores (From baseline to Week 13)
B: Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. (6 months)
C: Primary outcome measure is the Impairment level SumScore (ISS): pain, active range of motion and temperature, measured with VAS, McGill Pain Questionnaire, goniometry of mobility of joints and skin thermometer (t=0; t= 3 months; t= 6 months; t= 9 months)
D: The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8-Week Multi-Center, Randomized, Double Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150mg-600mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Symptoms Of Neuropathic Pain
Brief Summary: The objective of this study is to evaluate the efficacy, safety and tolerability for pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the symptoms of neuropathic pain.


Options:
A: A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary (Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study))
B: Onset meaningful pain reduction
C: The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
D: Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 5 and 9))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2)
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early stage breast cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens to compare how well they work in treating patients with early stage breast cancer that has been removed by surgery.


Options:
A: Pathologic complete response
B: Determination of pCR rates (2010)
C: Disease-free survival (DFS) at 5 years
D: Number of Participants With Disease-free Survival (DFS) Event (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Understanding the Prognostic Benefits of Exercise and Anti-depressant Therapy (UPBEAT)
Brief Summary: Some individuals with coronary heart disease (CHD) suffer from depression and use antidepressant medications to reduce symptoms. However, preliminary research has shown that exercise may be a more effective way to treat depression in these individuals. The purpose of this study is to evaluate the effects of exercise in reducing depression and improving heart function in individuals with CHD.


Options:
A: HAM-D17 (Before and after 3 months intervention)
B: Measured at Week 16 and Months 6 and 12 post-treatment: Post-treatment recovery from MDD; Post-treatment depression scores on the Hamilton Depression Rating Scale
C: Hamilton Depression Rating Scale (Measured at 16 weeks)
D: Depression Score (6 months); Abstinent From Smoking (6 months); Days Walk Per Week (6 months); Minutes Per Week of Moderate Physical Activity (6 months); Minutes Per Week of Vigorous Physical Activity (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Understanding the Prognostic Benefits of Exercise and Anti-depressant Therapy (UPBEAT)
Brief Summary: Some individuals with coronary heart disease (CHD) suffer from depression and use antidepressant medications to reduce symptoms. However, preliminary research has shown that exercise may be a more effective way to treat depression in these individuals. The purpose of this study is to evaluate the effects of exercise in reducing depression and improving heart function in individuals with CHD.


Options:
A: Hamilton Depression Rating Scale (Measured at 16 weeks)
B: Change in Depression (difference between the intervention and the control group) (At baseline and 3 months later (after intervention)); Change in Anxiety (difference between the intervention and the control group) (At baseline and 3 months later (after intervention))
C: Score on the Hamilton Depression Rating Scale-17 item (24 weeks)
D: Acceptability (From the completion of the manual till 4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans
Brief Summary: Objective: To study the efficacy and tolerability of mirtazapine (Remeron) in the treatment of PTSD.

Research Design: This is an 8-week randomized, double-blind, placebo-controlled treatment trial of mirtazapine for the treatment of PTSD as defined on the Clinical Assessment of PTSD Scale (CAPS).

Methodology: After signing an informed consent and meeting all inclusion/exclusion criteria, the patient is randomized to either mirtazapine versus placebo for 8-week duration. During the study a pharmacist maintains the randomization log and verifies the order for the placebo or mirtazapine in look-a-like tablets. Patients' symptoms, side effects and compliance are assessed bi-weekly. Based on symptomology and occurrence of side effects, the investigator increases the medication in 15 mg increments, as tolerated, until a maximum therapeutic benefit is achieved, not to exceed 45 mg/day. The dosing is at bedtime. Compliance is assessed by bi-weekly pill count at week 4 and week 8. Patients are given supportive clinical management during the clinic visits. An investigator is available by telephone 24 hrs a day in case of emergency. Patients may be seen more often if needed. Efficacy will be measured by the following assessment scales: Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Scale (Ham-A), Clinical Global Impression Severity of Illness (CGI-s), Clinical Global Impression of Improvement (CGI-I), Global Assessment of Functioning (GAF), CAPS, Treatment Outcome PTSD rating scale (TOP-8), and Davidson Trauma Scale (DTS).

Clinical Significance: Mirtazapine has shown promise in treating PTSD in an open label trial. This study is the next step in proving mirtazapine's efficacy in treatment of PTSD.


Options:
A: Impact of Event Scale - Revised (IES-R) (7 days after first infusion)
B: Short PTSD Rating Interview (SPRINT) (8 weeks); Pittsburgh Sleep Quality Index (PSQI) (8 weeks)
C: PTSD symptoms (four months); PTSD Diagnosis (4 months)
D: Structured Interview of Posttraumatic Stress Disorder (SIP) (Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Clinical Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes
Brief Summary: The project is a randomized clinical trial with a follow up time of 12 months comparing the effects of surgical treatment of idiopathic macular holes. Patients are randomized to vitrectomy alone, vitrectomy plus indocyanine green (ICG) assisted inner limiting membrane ( ILM) peeling or vitrectomy plus trypan blue (tb) assisted ILM peeling. At baseline patients are characterized using early treatment diabetic retinopathy study (ETDRS) visual charts, tests of aniseikonia, optical coherence tomography 3 (OCT3), visual field and fundus photography. Per- and postoperative complications are registered.

Data analyses will help clarify the effect of ILM peeling on hole closure and visual acuity. Comparing results after ICG- and tb assisted ILM peeling will help clarify the topic of a toxic effect on retinal cells after staining and peeling of the ILM. Changes in intraretinal morphology before and after dye-assisted ILM peeling will be studied using OCT3 imaging and the patients' subjective opinion on the surgical results will be analyzed using quality of life questionnaires and metamorphopsia tests.


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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Step'n Out: A Multisite Trial of Collaborative Behavioral Management for Drug-Involved Parolees
Brief Summary: The main purpose of this study is to examine whether improved integration between the community supervision system and outpatient addiction treatment system can improve treatment adherence, drug use and public safety outcomes among drug-involved inmates re-entering the community.


Options:
A: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)
B: rates of pregnancy and out-of-wedlock child birth (At age 19); educational achievement, including graduation from high school and participation in various types of post-high school education (At age 19); participation in the work force, including enrollment in the armed services (At age 19); use of welfare (At age 19); use of substances (cigarettes, alcohol, and illegal drugs) (At age 19); involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) (At age 19)
C: Condom use (one year)
D: Rearrest

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Financial Incentives to Translate ALLHAT Into Practice
Brief Summary: The purpose of this study was to determine whether financial incentives for guideline-recommended treatment of hypertension are effective. We hypothesized that patients with hypertension cared for by physicians or practice groups receiving financial incentives were more likely to be prescribed guideline-recommended anti-hypertensive medications and achieve Joint National Commission (JNC) 7 guideline-recommended blood pressure goals compared to patients who were treated by providers that did not receive financial incentives.


Options:
A: Number of Participants Who Present Children for HIV Testing (2 months); Number of Days Participants Take to Bring Children for HIV Testing (2 months)
B: Proportion of participants who receive an HIV test at a community health campaign between intervention groups (6-8 weeks after enrollment; annually); Proportion of participants with HIV RNA <400 copies/mL between intervention groups (6 months after enrollment); Proportion of participants randomized to loss aversion trial who make a deposit (At enrollment); Proportion of participants who complete all HIV retest visits at study venue (6 months)
C: HIV Viral Suppression (12 months)
D: Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure (Baseline period (August-November 2007)); Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure (Final intervention period (April-July 2009)); Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure (After the washout period (May-August 2011)); Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications (Baseline period (August-November 2007)); Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications (Final intervention period (April-July 2009)); Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications (After the washout period (May-August 2011))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Multi-Source Feedback to Pediatric Residents: The Formative Value of an ACGME Competency-Based Assessment Tool.
Brief Summary: The purpose of this study is to test whether multi-source feedback, including self-assessment and tailored coaching, improves resident communication skills and professionalism. We hypothesize that residents who are assigned to receive multi-source feedback, in addition to receiving standard feedback, will improve significantly more than residents receiving standard feedback alone, as measured by parent and nurse ratings of specific behaviors over time.


Options:
A: Bone mineral density (BMD) testing rates
B: The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care. (30 months)
C: completing CRC screening test (1 and 6 months post education)
D: The difference between groups in the change in parent and nurse ratings of specific communication skills and professionalism behaviors from baseline to follow-up (average 5 months later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Multi-Source Feedback to Pediatric Residents: The Formative Value of an ACGME Competency-Based Assessment Tool.
Brief Summary: The purpose of this study is to test whether multi-source feedback, including self-assessment and tailored coaching, improves resident communication skills and professionalism. We hypothesize that residents who are assigned to receive multi-source feedback, in addition to receiving standard feedback, will improve significantly more than residents receiving standard feedback alone, as measured by parent and nurse ratings of specific behaviors over time.


Options:
A: The difference between groups in the change in parent and nurse ratings of specific communication skills and professionalism behaviors from baseline to follow-up (average 5 months later)
B: Change in antibiotic prescription patterns for respiratory infections (1 year)
C: Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls (nine months)
D: Episiotomies; Oxytocin use in third stage of labor

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Multi-Source Feedback to Pediatric Residents: The Formative Value of an ACGME Competency-Based Assessment Tool.
Brief Summary: The purpose of this study is to test whether multi-source feedback, including self-assessment and tailored coaching, improves resident communication skills and professionalism. We hypothesize that residents who are assigned to receive multi-source feedback, in addition to receiving standard feedback, will improve significantly more than residents receiving standard feedback alone, as measured by parent and nurse ratings of specific behaviors over time.


Options:
A: The difference between groups in the change in parent and nurse ratings of specific communication skills and professionalism behaviors from baseline to follow-up (average 5 months later)
B: Hospital rate of permanent colostomy; Hospital rate of local recurrence
C: Change in t-PA use with assessment of appropriateness of use and complications. (January 2005 to January 2010)
D: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome
Brief Summary: The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.


Options:
A: Peak 6-minute Walk Distance (12 weeks)
B: Change in 6-minute walk distance (Baseline to End-of-Period 1)
C: 6 minutes walking distance
D: Change from baseline at Week 12 of six minute walk distance

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome
Brief Summary: The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.


Options:
A: 6 minutes walking distance
B: Pulmonary Artery Systolic Pressure (PASP)
C: Number of Participants With Treatment-emergent Adverse Events (TEAE) (From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years); Number of Participants With Death (From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit))
D: 6 minute walking distance (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome
Brief Summary: The purpose of this study is to investigate if combination treatment with Bosentan and Sildenafil to patients with Eisenmenger syndrome is beneficial.


Options:
A: Time to Death or Disease (IPF) Progression. (Up to 48 months)
B: Improvement in six minute walk distance (16 weeks)
C: Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR). (From enrollment/baseline to Week 12 in the Double Blind (DB) treatment period)
D: 6 minutes walking distance

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial for the Prevention of Premature Birth and Neonatal Related Morbidity
Brief Summary: The trial intends to evaluate the efficacy of specially designed probiotics to prevent premature birth and related neonatal morbidity associated to intra-uterine infection. The tested probiotics are efficacious to decrease the prevalence of bacterial vaginosis. The study hypothesis is that the early administration of those probiotics to pregnant women with bacterial vaginosis can prevent premature birth through antibiotic activity and modulation of the immune response to infection.


Options:
A: Spontaneous premature birth (<37, <35, <32 weeks of pregnancy) (24 weeks)
B: Effect of VSL#3 probiotic administration on breast milk (2 months)
C: Prevalence of atopic disease in infant (two years)
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Telemonitoring to Improve Heart Failure Outcomes
Brief Summary: The primary purpose of this study is to determine the effectiveness of telemonitoring compared with usual guideline-based care in preventing hospitalization for heart failure patients.


Options:
A: Rate of all-cause hospital readmission or death during the 6-month follow-up period. (6 months)
B: Treatment Completion (13 weeks); PTSD Checklist-Military (PCL-M) (26 weeks); Beck Depression Inventory-II (BDI-II) (26 weeks)
C: Feasibility (7 months)
D: The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder (November 2008-November 2009)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Telemonitoring to Improve Heart Failure Outcomes
Brief Summary: The primary purpose of this study is to determine the effectiveness of telemonitoring compared with usual guideline-based care in preventing hospitalization for heart failure patients.


Options:
A: Tobacco Abstinence - 6 Month Follow-up (6 months)
B: Participation in exercise (weekly minutes of exercise) at 6 months.
C: Rate of all-cause hospital readmission or death during the 6-month follow-up period. (6 months)
D: Changes in the Physical Component Summary of the SF-12 Health Survey (Baseline and 6 months); Changes in the Mental Component Summary of the SF-12 Health Survey (Baseline and 6 months)

Answer: C