TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Study PXN110448: A Dose-response Study of XP13512, Compared With Concurrent Placebo Control and LYRICA(Pregabalin), in Subjects With Neuropathic Pain Associated Withdiabetic Peripheral Neuropathy (DPN)
Brief Summary: The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)


Options:
A: 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 6 and 11)); DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 6 and 11))
B: Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo (Baseline up to Week 5 postdose, up to 10 months total follow up)
C: Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population) (Endpoint- Week 8 or Early Discontinuation)
D: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Chronic Kidney Disease Prevention of An-Lo District, Keelung.
Brief Summary: The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan (1, 2). More than 45,000 patients are under renal replacement therapy in the year 2004 (2). The disease had not only caused a significant impact in personal life, but also a great burden on social security and government-run health insurance. However, despite this high prevalence, the awareness of chronic kidney disease (CKD) in general population remains low (3, 4). The patients always come out too late for the intervention to slow down the progression of renal failure. Furthermore, most of them are not well prepared for the renal replacement therapy. The facts result in high mortality and morbidity in this specific population (5). It is mandatory to screen out and treat these patients early enough. However, these patients are deep into the community as the asymptomatic nature of CKD.

The major purpose of the study is to screen the community for the early CKD and provide the appropriate intervention at time. The study will collect the characteristic demographic epidemiological data and find out risk factors for CKD of this geographic area, provide multidisciplinary education of CKD and establish timely referral for appropriate nephrologist care for treatment and monitoring of complications.


Options:
A: Referral for Kidney Transplantation (One Year)
B: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)
C: Knowledge about Living Kidney Donation (3 weeks)
D: reduction of estimated glomerular filtration rate by 50 % (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Observer-blind, Controlled, Multi-center Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of One and Two Intramuscular Doses of Influenza Vaccine Versus Control Vaccines in Healthy Subject Aged 6 to <72 Months
Brief Summary: This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5 mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza and non-adjuvanted influenza control vaccines in subjects 6 to \<72 months of age.


Options:
A: Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control. (7 days post-vaccination); Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine) (3 weeks after 2nd vaccination)
B: Geometric Mean Titer 30 Days After the Last Study Vaccination (30 days after the last study vaccination); Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination (30 days after the last study vaccination)
C: The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.
D: The primary efficacy endpoint of this study is the relative efficacy of CAIV-T; compared to TIV against the incidence of culture-confirmed symptomatic influenza infection caused by community-acquired wild-type strains antigenically similar to those contained in the vaccine, occurring during the; influenza surveillance period and at least 14 days after the last required vaccination

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: NIMH Multisite HIV/STD Prevention Trial for African American Couples
Brief Summary: This study will evaluate the effectiveness of a risk-reduction program in preventing the transmission of HIV and sexually transmitted diseases among African-American heterosexual couples, with one partner having been previously diagnosed with an HIV infection.


Options:
A: HIV incidence
B: Self-reported proportion of condom-protected sexual intercourse (Measured at Month 12); Occurrence of STDs (chlamydia, gonorrhea, and trichomonas) (Measured at Month 12)
C: Frequency of unprotected sexual acts with nonspousal partners (Measured at baseline and Years 1 and 2); Overall observed incidence of sexually transmitted diseases (STDs) (e.g., chlamydia, gonorrhea, syphilis, trichomonas, HIV, or herpes simplex virus-2), as detected by biological specimens (Measured at baseline and Years 1 and 2)
D: Proportion of condom protected vaginal sex acts over the last 60 days (6 and 12 months post-randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide And Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant
Brief Summary: This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.


Options:
A: Progression-free Survival (From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years)
B: Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC) (up to 165 weeks)
C: Progression-Free Survival (PFS) (Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.)
D: Progression-Free Survival (From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Using a Telemedicine System to Promote Patient Care Among Underserved Individuals
Brief Summary: We have established a Telemedicine System for chronic disease management. Based on a personal health record, we have successfully used this system in diverse populations, in over 600 patients, and in multiple disease states (heart failure, CVD risk reduction, gestational diabetes). In this proposal, we will enhance this Telemedicine system to support patient centered care (PCC) by increasing access, incorporating hypertension treatment guideline, quality measures, automating reminders and feedback for both patients and health care providers.

Inner-city, primarily African-American patients (N=252) with uncontrolled hypertension (BP\<140/90 mmHg) and who are followed by primary care physicians will be randomized to either a usual care or a telemedicine group (Telemedicine plus usual care). Blood pressure, weight, BMI, blood glucose and lipids, and physical activity will be measured at baseline and at 6 months. We hypothesize that more subjects in the telemedicine group will achieve goal blood pressure than in the control group. This will occur through increases in knowledge, self-management, shared decision-making, and improved doctor-patient interaction. Primary end- point will be the proportion of subjects who achieve goal blood pressure. Secondary end-points will include:

Rate of self-monitoring, steps per day, weight, CVD knowledge, number of patients at medication guidelines, and increased satisfaction with practice. Telemedicine utilization will also be determined. We believe that telemedicine can facilitate PCC and reduce blood pressure in a cost effective manner.


Options:
A: Lowering of blood pressure from hypertension to prehypertension in 50% of study subjects (6 months)
B: The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l), (18 months)
C: glycosolated hemoglobin (HbA1c) levels (one year)
D: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Using a Telemedicine System to Promote Patient Care Among Underserved Individuals
Brief Summary: We have established a Telemedicine System for chronic disease management. Based on a personal health record, we have successfully used this system in diverse populations, in over 600 patients, and in multiple disease states (heart failure, CVD risk reduction, gestational diabetes). In this proposal, we will enhance this Telemedicine system to support patient centered care (PCC) by increasing access, incorporating hypertension treatment guideline, quality measures, automating reminders and feedback for both patients and health care providers.

Inner-city, primarily African-American patients (N=252) with uncontrolled hypertension (BP\<140/90 mmHg) and who are followed by primary care physicians will be randomized to either a usual care or a telemedicine group (Telemedicine plus usual care). Blood pressure, weight, BMI, blood glucose and lipids, and physical activity will be measured at baseline and at 6 months. We hypothesize that more subjects in the telemedicine group will achieve goal blood pressure than in the control group. This will occur through increases in knowledge, self-management, shared decision-making, and improved doctor-patient interaction. Primary end- point will be the proportion of subjects who achieve goal blood pressure. Secondary end-points will include:

Rate of self-monitoring, steps per day, weight, CVD knowledge, number of patients at medication guidelines, and increased satisfaction with practice. Telemedicine utilization will also be determined. We believe that telemedicine can facilitate PCC and reduce blood pressure in a cost effective manner.


Options:
A: Appropriateness of Decision to Treat or Not Treat With Thrombolytics (potentially within 3 hours of symptom onset)
B: Lowering of blood pressure from hypertension to prehypertension in 50% of study subjects (6 months)
C: Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months (One year post-enrollment)
D: Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) (baseline, 3, 6, 9, and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Using a Telemedicine System to Promote Patient Care Among Underserved Individuals
Brief Summary: We have established a Telemedicine System for chronic disease management. Based on a personal health record, we have successfully used this system in diverse populations, in over 600 patients, and in multiple disease states (heart failure, CVD risk reduction, gestational diabetes). In this proposal, we will enhance this Telemedicine system to support patient centered care (PCC) by increasing access, incorporating hypertension treatment guideline, quality measures, automating reminders and feedback for both patients and health care providers.

Inner-city, primarily African-American patients (N=252) with uncontrolled hypertension (BP\<140/90 mmHg) and who are followed by primary care physicians will be randomized to either a usual care or a telemedicine group (Telemedicine plus usual care). Blood pressure, weight, BMI, blood glucose and lipids, and physical activity will be measured at baseline and at 6 months. We hypothesize that more subjects in the telemedicine group will achieve goal blood pressure than in the control group. This will occur through increases in knowledge, self-management, shared decision-making, and improved doctor-patient interaction. Primary end- point will be the proportion of subjects who achieve goal blood pressure. Secondary end-points will include:

Rate of self-monitoring, steps per day, weight, CVD knowledge, number of patients at medication guidelines, and increased satisfaction with practice. Telemedicine utilization will also be determined. We believe that telemedicine can facilitate PCC and reduce blood pressure in a cost effective manner.


Options:
A: Change in Numeric Rating Scale of Pain Intensity (post-treatment (12 weeks), 3 and 6 months post-baseline)
B: The incidence and frequency of COPD exacerbations in each of the intervention groups (December 2008 to March 2009 inclusive); Electronic diary symptoms using the EXACT instrument (Daily recording)
C: Lowering of blood pressure from hypertension to prehypertension in 50% of study subjects (6 months)
D: Mammography Adherence (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Centre, Randomised Controlled Study of the Effect of NOGA-guided Direct Intramyocardial Injection of Mesenchymal Stromal Cells on the Development of New Myocardium and Blood Vessels in Patients With Heart Failure
Brief Summary: It is a single centre, randomised controlled study of the effect of NOGA-guided direct intramyocardial injection of mesenchymal stromal cells on the development of new myocardium and blood vessels in patients with heart failure.

Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before injected into the myocardium.

The patients will be followed with safety, clinical, MRI and CT endpoints for 1 year.


Options:
A: Improvements in left ventricular function (6 and 12 months)
B: Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol (Baseline and 12 month visit)
C: Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke (12 months)
D: Change in left ventricular ejection fraction (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis
Brief Summary: Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.

This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of 40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS characteristics will be divided into two groups: one group receiving the high dose Vitamin D regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher doses will demonstrate improved relapse and disability status compared to controls, and that the treatment group will show improved markers of bone health and immune indicators of reduced inflammation.


Options:
A: Serum calcium (at each dose change)
B: Bone Density of the hip
C: fractures (3 year follow-up)
D: The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis
Brief Summary: Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.

This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of 40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS characteristics will be divided into two groups: one group receiving the high dose Vitamin D regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher doses will demonstrate improved relapse and disability status compared to controls, and that the treatment group will show improved markers of bone health and immune indicators of reduced inflammation.


Options:
A: Serum calcium (at each dose change)
B: Changes in BMD over the 2 year study period comparing treatment and placebo groups (2 years)
C: Percentage of Subjects With Disease Activity Free Status up to Week 48 (Up to Week 48)
D: Occurrence and severity of Interferon beta related Flu Like Symptoms and Injection Site Reactions. (One year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis
Brief Summary: Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.

This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of 40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS characteristics will be divided into two groups: one group receiving the high dose Vitamin D regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher doses will demonstrate improved relapse and disability status compared to controls, and that the treatment group will show improved markers of bone health and immune indicators of reduced inflammation.


Options:
A: incidence of pneumonia (18 months)
B: Time taken for recovery from severe pneumonia (12 months)
C: Serum calcium (at each dose change)
D: Change in serum level of 25hydroxycholecalciferol (25(OH)D) (At baseline and 7 days after vitamin D3 (Cholecalciferol) injection)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3B 12-Week, Double -Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Varenicline Tartrate (CP-526,555) 1 mg BID for Smoking Cessation in Subjects With Schizophrenia and Schizoaffective Disorder.
Brief Summary: Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.


Options:
A: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
B: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)
D: Continuous abstinence from smoking (Six months post-quit date)

Answer: C