TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An RCT to Determine if APBI, Utilizing 3D CRT, is as Effective as Whole Breast Irradiation Following Breast Conserving Surgery in Women With Ductal Carcinoma in Situ or Invasive Breast Cancer With Negative Axillary Lymph Nodes
Brief Summary: To determine if Accelerated Partial Breast Irradiation, using 3D CRT, is as effective as Whole Breast Irradiation following breast conserving surgery in women with an new histological diagnosis of ductal carcinoma in situ only or invasive breast cancer without evidence of metastatic disease. Effectiveness will be determined by the rate of ipsilateral breast tumour recurrence.

General objective is to improve the convenience and quality of life of female patients who receive breast irradiation.


Options:
A: ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail. (ongoing throughout study)
B: Ipsilateral Breast Tumor Recurrence (5-year)
C: In-breast tumor recurrence (IBTR) (every 6 months for 5 years; annually thereafter for up to 10 years)
D: rate of local recurrence (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial
Brief Summary: The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.


Options:
A: Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS (Every 3 months up to two years)
B: N/A
C: Event-free survival (Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years)
D: Progression Free Survival rate at 6 months (6 months from registration into the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease
Brief Summary: Bilateral subthalamic nucleus deep brain stimulation (B-STN DBS) is one of the most effective surgical treatments for PD patients suffering from levodopa-induced motor complications. The relatively low incidence of permanent adverse effects and the potential for neuroprotection and alteration of the natural course of PD suggest a highly favorable benefit-to-risk ratio of this procedure. Since neuroprotection is best applied early in the disease course when there are more surviving neurons, we believe that further investigation of this procedure is warranted. The proposed pilot study will provide the necessary data to substantiate the safety and tolerability of the procedure as well as provide data for the design of a full-scale, multicenter trial to investigate the hypothesis that B-STN DBS is a safe and effective treatment to slow the progression of PD.


Options:
A: Safety: Time to Reach a 4 Point Increase (Worsening) in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score (baseline to 24 months); Levodopa Equivalents, Change From Baseline (baseline to 24 months)
B: cognitive improvement (one- year)
C: Severity of tics
D: Reduction of Levomethadone (seven month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Brief Summary: This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).


Options:
A: Proportion of Participants With at Least One Serious Infection Through Week 24 (Through Week 24); Number of Participants With Any Infections or Any Grade 3/4 Infections Through Week 24 (Through Week 24); Maximum Duration of Infections Through Week 24 (Week 24); Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Week 24 (Through Week 24); Number of Participants With Clinically Significant Immunological and Laboratory Assessment Findings (Through Week 24)
B: Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine (Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B)
C: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
D: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Telemedical and Conventional Antihypertensive Treatment
Brief Summary: The aim of the study is to compare telemedical antihypertensive treatment based on home blood pressure monitoring and conventional antihypertensive treatment based on monitoring of blood pressure in the doctor's office.

We want to test the hypotheses that telemedical treatment is more effective in lowering blood pressure, provide better quality of life and is more cost-effective.


Options:
A: Respiratory Events (9 months)
B: Difference in Number of Patients Who Reached Target Blood Pressure (6 months); Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months (baseline and 6 months)
C: Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale (Baseline and 1 year); Changes in Minutes of Moderate Physical Activity (Baseline and 1 year); Changes in Minutes of Vigorous Exercise (Baseline and 1 year)
D: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission. (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis
Brief Summary: This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF) compared with placebo in combination with MMF in subjects diagnosed with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis.


Options:
A: To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN (18 months)
B: Number of Participants With Complete Response (Week 24)
C: Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52 (Week 52)
D: renal remission and renal response (at the end of induction (month 9) and maintenance (month 18) phase)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sacral Transcutaneous Nerve Stimulation Treatment for Functional Daytime Incontinence in Children With Over Active Bladder Syndrome
Brief Summary: The purpose of this study is to perform a randomized controlled investigation of the effect of surface nerve stimulation on functional daytime incontinence in children with OAB.


Options:
A: Quality of life, as measured by a validated enuresis-specific quality of life scale
B: Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition (Baseline and Week 12)
C: Clinical effects evaluated by home registrations of degree of incontinence, VAS score of degree of urgency and frequency volume charts at specified intervals. Acute effect evaluated by urodynamics.
D: voiding frequency (before therapy and at end of therapy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: (Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)
Brief Summary: Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.


Options:
A: Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
B: Ankle brachial index (6 months)
C: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)
D: The safety of MultiGeneAngio will be assessed by monitoring adverse events (Up to 15 years after treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: (Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)
Brief Summary: Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.


Options:
A: Therapy Success (6 months)
B: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)
C: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)
D: Ankle brachial index (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: (Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)
Brief Summary: Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.


Options:
A: AE and symptomatic relief (6 months)
B: Clinical and instrumental indexes of functional impairment of peripheral atherosclerosis.
C: Ankle brachial index (6 months)
D: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Outcomes With Use Of Intensive Insulin Therapy In Intraoperative Management Of Hyperglycemia In Adult Patients Undergoing Cardiac Surgery
Brief Summary: Patients with or without diabetes may have high blood sugar levels due to stress response of the body during heart surgery. This study is being done to determine if maintaining normal blood sugar levels during open-heart surgery by using intravenous insulin results in a lesser incidence of death, wound infections in the chest, disturbances of heart rhythm, kidney failure, stroke and prolonged time on the breathing machine (artificial ventilation) within 30 days after surgery.


Options:
A: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
B: Percentage of patients in the glucose target range within 24 hours of the initiation of treatment. (24 hours)
C: Mortality; Sternal wound infections; Stroke; Cardiac arrhythmias; Renal failure
D: Mortality (28 day); Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Identification and Therapy of Postpartum Depression
Brief Summary: This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.


Options:
A: Depressive symptoms, social functioning, and health (Measured at Months 3, 6, and 12 postpartum); Preferences for depression treatment (Measured at baseline and Month 12)
B: Change in PTSI symptoms (Baseline, Immediately Post- intervention, 2 months post-intervention, 6 months post-intervention)
C: mother and father resolving of conflict (pre-intervention, post-intervention (up to 9 months after pre-intervention), up to 18 months after pre-intervention, up to 27 months after pre-intervention)
D: SCL-20 depression (baseline, 3, 6 12, 18 month follow-ups)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Identification and Therapy of Postpartum Depression
Brief Summary: This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.


Options:
A: Depressive symptoms, social functioning, and health (Measured at Months 3, 6, and 12 postpartum); Preferences for depression treatment (Measured at baseline and Month 12)
B: depression (12 weeks)
C: Hamilton Depression Rating Scale (HAM-D) (Measured at baseline; post-treatment; and Months 3 and 6 of follow-up)
D: EPDS (3 and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Detrol LA "Add-On" To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker.
Brief Summary: An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction.

Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary).

Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.


Options:
A: Patient Perception of Bladder Condition at 12 weeks of treatment
B: Change From Baseline to End of Treatment in Total International Prostate Symptom Score (Baseline and Week 12); Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS]) (Baseline and Week 12)
C: Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) (Baseline and Week 12); Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) (Baseline and Week 12)
D: Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
B: Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment (from week 9 to week 48)
C: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
D: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
B: Change in Metabolic Syndrome Prevalence (Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
C: urine carcinogen biomarker of exposure, NNAL (week 24)
D: Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD). (6 months following quit day.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: Continuous Nicotine Abstinence (8 weeks)
B: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
C: Smoking Abstinence (12 months)
D: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
B: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
C: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
D: Smoking Status (at week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
B: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
C: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
D: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date (4 Weeks Following Smoking Quit Date (Study week 7)); Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date (12 Weeks Following Smoking Quit Date (Study week 15)); 7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date (4 Weeks Following Smoking Quit Date (Study week 7)); 7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date (12 Weeks Following Smoking Quit Date (Study week 15)); 7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date (26 Weeks Following Smoking Quit Date (Study week 29)); 7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date (52 Weeks Following Smoking Quit Date (Study week 55))
B: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
C: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
D: smoking cessation (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Brief Summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Options:
A: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
B: 7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8) (8 weeks)
C: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
D: effectiveness (2 years)

Answer: C