TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone-Based Genetic Counseling; An Equivalence Trial
Brief Summary: RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.

PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.


Options:
A: Prostate Specific Antigen (PSA) Screening Rates (Up to Month 3); Patient Knowledge Survey Score (Day 1); Decision Quality Score (Day 1); Percentage of Participants Who Make Informed Choice (Day 1)
B: Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months (6 months); Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months (3 months); Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months (3 months); Quality of life as assessed by SF-12 health survey at 3 and 6 months (6 months); Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months (6 months)
C: Men's understanding that prostate cancer screening requires a decision (baseline, post intervention, post clinical visit); Men's knowledge about prostate cancer and prostate cancer screening (baseline, post intervention, post clinical visit); Men's participation in the decision about prostate cancer screening with their clinician at their preferred level (baseline, post intervention, post clinical visit)
D: Overall Screening Adherence (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study Exploring the Efficacy of Capecitabine Given Concomitantly or in Sequence to EC-Doc With or Without Trastuzumab as Neoadjuvant Treatment of Primary Breast Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, docetaxel, and capecitabine, 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. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving monoclonal antibodies after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without capecitabine and/or trastuzumab in treating breast cancer.

PURPOSE: This randomized phase III trial is studying epirubicin, cyclophosphamide, and docetaxel to compare how well they work with or without capecitabine and/or trastuzumab before surgery in treating women with stage I, stage II, or stage III breast cancer.


Options:
A: Pathologic complete response
B: Recurrence-free survival
C: Overall Survival (OS) (From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years); Progression Free Survival (PFS) (From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date of 12 Mar 2012 or up to approximately 6 years)
D: Number of Participants With Disease-free Survival (DFS) Event (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Study Of Sirolimus Eluting Stent Vs Conventional Stent In Acute Myocardial Infarction Acronym SESAMI
Brief Summary: The incidence of stent restenosis in the setting of primary angioplasty is particularly high, reaching a rate of 27% In the last years the introduction of drug-eluting stents has drastically reduced the incidence of restenosis in patients not requiring urgent revascularization. Whether drug-eluting stenting might constitute the new optimal therapy for patients with an acute myocardial infarction is unknown. To be able to answer this question, we designed a randomized trial in which patients with an acute myocardial infarction eligible for treatment with primary angioplasty and abciximab were randomized to receive either a rapamicine-eluting stent or a conventional bare stent.


Options:
A: First occurrence of all-cause mortality and non-fatal myocardial infarction (composite) (After five years of follow-up)
B: The primary end point was target lesion revascularization (TLR) at 1-year follow-up (1 year)
C: ST segment resolution (90 min); Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up). (immediately after and at 8 month follow up)
D: The primary end point for the trial was the binary restonis at one year angiographic follow-up

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mechanical Bowel Preparation for Elective Colorectal Surgery. A Multicenter Randomized Study
Brief Summary: Mechanical bowel preparation (MBP) is common practice in elective colorectal surgery. In recent literature the value of MBP is subject of discussion. We conducted a multicenter, randomized study with the goal of comparing outcome of elective colorectal resections and primary anastomoses with and without mechanical bowel preparation in terms of anastomotic leakage and other septic complications.

Within the setting of a multicenter randomized trial,1433 patients were randomized before elective colorectal surgery to receive either MBP or to have no MBP but a normal meal on the day before operation. The primary endpoint was anastomotic leakage. Secondary endpoints were septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses), fascia dehiscence and death.

The incidence of anastomotic leakage was similar in both groups: 5.1% in patients without MBP versus 4.9% in patients with MBP (p=0.93; 95% confidence interval for the difference (no MBP minus MBP) ranges from -2.3% tot +2.7%). There were no significant differences in other septic complications, fascia dehiscence, or mortality. Fecal contamination, number of days until resumption of a normal diet, and duration of hospital stay were similar in both groups.

This study shows that elective colorectal surgery can be safely done without MBP. Therefore, MBP should be abandoned in elective colorectal surgery.


Options:
A: Comprehensive Complication Index (Within 30 days from surgery)
B: The primary endpoint of the study was anastomotic failure.
C: Surgical Site Infections (30 days (exact 30 days after the Operation date))
D: Rate of Surgical Site Infection (0 to 30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia
Brief Summary: The aim of this study is to assess longer term safety and effectiveness of Dysport®.


Options:
A: Understanding of key findings (30 minutes)
B: Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4. (4 weeks post-treatment)
C: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (Baseline and Week 4)
D: Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline (Week 4 follow-up visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: IL1T-AI-0505: A Multi-center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, & Efficacy of Rilonacept in Subjects With Cryopyrin-Associated Periodic Syndromes (CAPS) Using Parallel Group & Randomized Withdrawal Designs
Brief Summary: Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1). These mutations result in the body's overproduction of interleukin-1 (IL-1), a protein that stimulates the inflammatory process. IL-1 Trap (rilonacept) was designed to bind to the interleukin-1 cytokine and prevent it from binding to its receptors in the body.


Options:
A: Mor severity scoring system (At baseline and every 12 weeks, up to 24 weeks. Change in disease severity as assessed by the Mor severity scoring system.); Adverse events (up to 24 weeks)
B: Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS) (Baseline (Days -21 to -1) and Week 6 (Days 21-42)); Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B) (Week 15 through Week 24 (randomized withdrawal))
C: Number of patients with less than a mean of one FMF attack per month (4 months)
D: Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: IL1T-AI-0505: A Multi-center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, & Efficacy of Rilonacept in Subjects With Cryopyrin-Associated Periodic Syndromes (CAPS) Using Parallel Group & Randomized Withdrawal Designs
Brief Summary: Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1). These mutations result in the body's overproduction of interleukin-1 (IL-1), a protein that stimulates the inflammatory process. IL-1 Trap (rilonacept) was designed to bind to the interleukin-1 cytokine and prevent it from binding to its receptors in the body.


Options:
A: To measure the effect of canakinumab on the frequency of FMF attacks defined as percentage of patients with at least 50% reduction in the attack frequency during 3 month treatment period. (12 weeks)
B: To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. (attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)); To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. (12 months of entire study length)
C: Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS) (Baseline (Days -21 to -1) and Week 6 (Days 21-42)); Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B) (Week 15 through Week 24 (randomized withdrawal))
D: Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-Management of Osteoarthritis: A Tailored, Telephone-based Intervention
Brief Summary: The purpose of this study is to examine whether a telephone-based self-management intervention improves pain, physical function, and other outcomes among veterans with osteoarthritis of the hip or knee.


Options:
A: Changes in the intensity of hip pain before and after the treatment (participants will be assessed before and after intervention (interval: 15-20 minutes))
B: Patient Global Impression of Change for Knee Pain (Assessed after the 8-16 week intervention)
C: Change in knee pain intensity from baseline at 4 weeks (4 weeks)
D: Pain (Baseline and 12-month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-Management of Osteoarthritis: A Tailored, Telephone-based Intervention
Brief Summary: The purpose of this study is to examine whether a telephone-based self-management intervention improves pain, physical function, and other outcomes among veterans with osteoarthritis of the hip or knee.


Options:
A: Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) (12-months)
B: Pain (Baseline and 12-month follow-up)
C: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (0, 4, 10, 16 months)
D: EQ5D (At baseline and at follow-up after 6 months); Arthritis self-efficacy scale (At baseline and at follow up after 6 months); One-leg rising from sitting to standing (At baseline and at follow up after 6 months); Grip Ability Test (At baseline and at follow up after 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Study of the Immunogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (RIX4414) as Primary Dosing of Healthy Infants in India Aged Approximately 8 Wks at the Time of the First Dose
Brief Summary: Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of the first dose.


Options:
A: Primary study endpoint: acute rotavirus diarrhoea occurring from 6 weeks of age to the end of the follow-up period in subjects who resided in randomized villages during the period when they were age-eligible to have received Rotarix. (24 months)
B: Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.
C: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
D: Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Study of the Immunogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (RIX4414) as Primary Dosing of Healthy Infants in India Aged Approximately 8 Wks at the Time of the First Dose
Brief Summary: Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of the first dose.


Options:
A: Immunogenicity (7 months)
B: Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.
C: Hospitalization for gastroenteritis (2 years)
D: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules (4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: LEVP2005-1/Part A: A Double-blind, Placebo-Controlled, Clinical Study to Investigate the Efficacy and Safety of Purified C1 Esterase Inhibitor (Human) for the Treatment of HAE in Acute Attacks
Brief Summary: The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.


Options:
A: Time to Beginning of Substantial Relief of the Defining Symptom (Within 4 hours after initial treatment)
B: Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period (12 weeks)
C: Number of acute angioedema attacks (Over 28 days of treatment)
D: The Mean Time Normalized Number of HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1 (13 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India
Brief Summary: The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the oral killed bivalent cholera vaccine when administered to individual residing in a cholera-endemic area in India.


Options:
A: Receipt of 2 complete or nearly complete swallowed doses of oral cholera vaccine (after completion of the vaccination campaign)
B: culture-proven V. cholerae O1 diarrhoea episodes severe enough to require treatment in a health care facility. (1095 days)
C: Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection (7 days to 6 months)
D: Change in Vibriocidal GMT (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India
Brief Summary: The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the oral killed bivalent cholera vaccine when administered to individual residing in a cholera-endemic area in India.


Options:
A: Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline (14 days after each dose of vaccine or placebo)
B: Cocaine Abstinence During Weeks 9 to 16 Inclusive (Over 8 weeks ( Study Weeks 9 to 16 inclusive))
C: adverse events (immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days)
D: culture-proven V. cholerae O1 diarrhoea episodes severe enough to require treatment in a health care facility. (1095 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Non-pharmacological Intervention Study for Prevention of Ischaemic Heart Disease Inter99
Brief Summary: In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results, most probably due to insufficient interventions and methodology.

Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.

After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.

The status for the project is that the four waves of intervention have been performed, the last follow-up was in March 2006.

Data collection finalized with 10 years follow-up via Central National Registries and a questionnaire. No further follow-up is scheduled for the main purposes of the study.

Analyses as regard the primary effect (on incidence of cardiovascular diseases) and secondary effect (on incidence of type 2 diabetes) are on-going. Analyses for a large number of spin off project are on-going.

More than 25 Ph.d. studies and more than 200 peer-review publication have so far been produced.

Summary of results, links to articles and theses at: www.Inter99.dk


Options:
A: Incidence of CHD and other lifestyle related diseases after ten years (2012)
B: Weight Change From Baseline to 12 Months (12 months)
C: The proportion of patients who reach normal levels of all glycaemic parameters. (Month 24 of the intervention)
D: Change in ambulatory activity (walking) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Non-pharmacological Intervention Study for Prevention of Ischaemic Heart Disease Inter99
Brief Summary: In spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results, most probably due to insufficient interventions and methodology.

Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control.

After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD.

The status for the project is that the four waves of intervention have been performed, the last follow-up was in March 2006.

Data collection finalized with 10 years follow-up via Central National Registries and a questionnaire. No further follow-up is scheduled for the main purposes of the study.

Analyses as regard the primary effect (on incidence of cardiovascular diseases) and secondary effect (on incidence of type 2 diabetes) are on-going. Analyses for a large number of spin off project are on-going.

More than 25 Ph.d. studies and more than 200 peer-review publication have so far been produced.

Summary of results, links to articles and theses at: www.Inter99.dk


Options:
A: Metabolic syndrome (1 year); General Cardiovascular Risk Profile: Framingham Heart Study (1 year)
B: The percentage of participants attending the health check compared between the groups (one-year recruitment)
C: Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up (Six months)
D: Incidence of CHD and other lifestyle related diseases after ten years (2012)

Answer: D