TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Phase III Study for Evaluating the Role of the Addition of Ovarian Function Suppression to Tamoxifen in Young Women With Hormone-Sensitive Breast Cancer Who Remain in Premenopause or Regain Menstruation After Chemotherapy
Brief Summary: The purpose of this study is to compare 5-year disease free survival rate (DFS rate) between the hormone receptor positive breast cancer patients who were added Goserelin to Tamoxifen for ovarian function suppression after neo-/adjuvant cytotoxic chemotherapy and the hormone receptor positive breast cancer patients who were treated with Tamoxifen.


Options:
A: Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) (Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.); Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS) (Time from randomization to the analysis data cut-off date when 124 DFS events had occurred. On the analysis data cut-off date, maximum time on study per patient was 102 months.)
B: DFS (5 Years)
C: N/A
D: all cause recurrence (the first 5 years after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ICU Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder Following Critical Illness
Brief Summary: The incidence of PTSD post ICU varies from unit to unit, however a significant number of patients have been shown to develop this disorder. Many patients do not recall their stay in ICU properly and yet can clearly recall nightmares, hallucinations or paranoid delusions, which may be very frightening for the patient to recall at a later stage. As yet, no interventional studies have had an impact on the development of PTSD in this population of patients. However, a recent observational multi-centre study suggested that those patients receiving a diary of their time in ICU had lower levels of symptoms of PTSD than those who did not. These results need to be verified in the form of a randomized study.


Options:
A: N/A
B: Hospital Anxiety and Depression Scale Score (3 & 6 months post-randomization)
C: Quality of Life (12 months)
D: Diagnosis of Post Traumatic Stress Disorder (3 months post critical illness)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ICU Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder Following Critical Illness
Brief Summary: The incidence of PTSD post ICU varies from unit to unit, however a significant number of patients have been shown to develop this disorder. Many patients do not recall their stay in ICU properly and yet can clearly recall nightmares, hallucinations or paranoid delusions, which may be very frightening for the patient to recall at a later stage. As yet, no interventional studies have had an impact on the development of PTSD in this population of patients. However, a recent observational multi-centre study suggested that those patients receiving a diary of their time in ICU had lower levels of symptoms of PTSD than those who did not. These results need to be verified in the form of a randomized study.


Options:
A: Diagnosis of Post Traumatic Stress Disorder (3 months post critical illness)
B: Hospital Anxiety and Depression Scale Score (3 & 6 months post-randomization)
C: Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. (Change from baseline at weeks 2, 6 and 12)
D: Post-traumatic Stress Disorder (chronic) by CAPS scores. (Four months, seven months, 14 moths, two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Vitamin D on Arteriovenous Fistulae Maturation Among ESRD Patients
Brief Summary: Patients requiring hemodialysis following kidney failure need a form of dialysis vascular access in order to undergo the dialysis procedure. Dialysis vascular access dysfunction is an enormous clinical problem. While the best form of vascular access is the arteriovenous fistula (AVF), its primary problem is early, aggressive cellular ingrowth that leads to poor maturation of the vessel, preventing its use for dialysis. Strategies to prevent AVF failure are needed.

Vitamin D is a hormone present in all human bodies and is important for good bone formation and immune function. There is new information that links vitamin D to the function of our veins and arteries, which are used in the creation of an arteriovenous fistulae. Our bodies can make vitamin D and can also get vitamin D from our diet. However, a majority of patients with chronic kidney disease and end-stage renal disease (ESRD) have low vitamin D levels (vitamin D deficiency). There are several benefits to correcting low vitamin D levels, however, it is not know whether correcting low vitamin D in the body will lead to better function of the vein and artery used for arteriovenous fistulae creation. The main goal of this pilot study is to examine the role of vitamin D supplementation on AVF maturation and useability for dialysis. Study results will be used to develop larger studies to examine the specific effect that vitamin D supplementation has on the vessels used for AVF creation and whether vitamin D promotes AVF maturation.


Options:
A: Change to diameter of vein (Initial assessment and 6 weeks after surgery)
B: Arteriovenous Fistulae Maturation (6 months)
C: Primary AVF patency. (12 months after AVF creation); Number of participants with adverse events as a measure of safety and tolerability of PRT-201. (12 months after AVF creation.)
D: Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Vitamin D on Arteriovenous Fistulae Maturation Among ESRD Patients
Brief Summary: Patients requiring hemodialysis following kidney failure need a form of dialysis vascular access in order to undergo the dialysis procedure. Dialysis vascular access dysfunction is an enormous clinical problem. While the best form of vascular access is the arteriovenous fistula (AVF), its primary problem is early, aggressive cellular ingrowth that leads to poor maturation of the vessel, preventing its use for dialysis. Strategies to prevent AVF failure are needed.

Vitamin D is a hormone present in all human bodies and is important for good bone formation and immune function. There is new information that links vitamin D to the function of our veins and arteries, which are used in the creation of an arteriovenous fistulae. Our bodies can make vitamin D and can also get vitamin D from our diet. However, a majority of patients with chronic kidney disease and end-stage renal disease (ESRD) have low vitamin D levels (vitamin D deficiency). There are several benefits to correcting low vitamin D levels, however, it is not know whether correcting low vitamin D in the body will lead to better function of the vein and artery used for arteriovenous fistulae creation. The main goal of this pilot study is to examine the role of vitamin D supplementation on AVF maturation and useability for dialysis. Study results will be used to develop larger studies to examine the specific effect that vitamin D supplementation has on the vessels used for AVF creation and whether vitamin D promotes AVF maturation.


Options:
A: Arteriovenous Fistulae Maturation (6 months)
B: To assess the safety of a single topical dose of PRT-201. (Day of AVG creation and 4 weeks After surgery.)
C: Access flow monthly for 3 months and 6th month (0,1st,2nd,3rd and 6th months) and Echocardiographic parameters at 6th month ( 0 and 6th months) (6 months)
D: Primary AVF patency. (12 months after AVF creation); Number of participants with adverse events as a measure of safety and tolerability of PRT-201. (12 months after AVF creation.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SMS Turkey: Harnessing the Power of TXT Messaging to Promote Smoking Cessation
Brief Summary: The purpose of this study is to develop and test a text messaging-based smoking cessation program for adults who are currently smoking and want to quit, living in Turkey.


Options:
A: End-of-intervention Varenicline Adherence (4 Weeks)
B: Carbon Monoxide-verified Continuous Abstinence at 12 Weeks (12-weeks post-quit day)
C: Smoking abstinence (Six months post-treatment)
D: Smoking cessation (Change in smoking status from baseline at 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SMS Turkey: Harnessing the Power of TXT Messaging to Promote Smoking Cessation
Brief Summary: The purpose of this study is to develop and test a text messaging-based smoking cessation program for adults who are currently smoking and want to quit, living in Turkey.


Options:
A: Smoking abstinence (Six months post-treatment)
B: Point prevalence abstinence of 7 days (6 months)
C: Carbon Monoxide-verified Continuous Abstinence at 12 Weeks (12-weeks post-quit day)
D: smoking quit rate change from baseline at 3-month follow-up (3-month follow-up); smoking quit rate change from baseline at 6-month follow-up (6-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cardiovascular Training on Fitness, Cardiovascular Health, Bone Health and Quality of Life in Individuals With Ankylosing Spondylitis
Brief Summary: To test the effects of a cardiovascular training compared to attention control in a group of AS-patients participating in classic spinal mobility exercise groups (randomized controlled trial)


Options:
A: Disease activity (12 weeks after baseline assessment)
B: Bath Ankylosing Spondylitis Functional Index (BASFI) (16 weeks)
C: Diagnosis of Spondyloarthritis (2 years)
D: Cardiovascular Fitness (Baseline and post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT
Brief Summary: The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy.


Options:
A: Negative Appendectomy (1 week after surgery)
B: sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient. (immediate reading + blinded reading within 48 hours)
C: The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis (Up to 10 years)
D: Proportion of negative appendectomies (During the hospital admission)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Appendectomy Rate Following Low-dose CT vs. Standard-dose CT
Brief Summary: The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy.


Options:
A: Patient-reported Quality of Life as Measured by EuroQol (EQ-5D) (Four-weeks after randomization)
B: Negative Appendectomy Rate (1 week after surgery)
C: Negative Appendectomy (1 week after surgery)
D: rate of intra abdominal infections in both therapeutic strategies (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate
Brief Summary: Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.


Options:
A: Percentage of Participant Who Were Non-Failures (Week 48)
B: RA inflammatory activity over 18 months based on repeated DAS28 measures (over 18 months)
C: Association Between Baseline Hand and Wrist Synovitis Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score and Flare up to Week 40 in the Tapering Arm (From Week 4 to Week 40); Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm (From Week 4 to Week 40); Association Between a Composite of Baseline Hand and Wrist Synovitis and Bone Marrow Edema RAMRIS Scores and Flare up to Week 40 in the Tapering Arm (From Week 4 to Week 40)
D: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate
Brief Summary: Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.


Options:
A: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)
B: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 16); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 8); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 4); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 2); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 1)
C: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)
D: Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169 (Day 169); Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups (Day 253 (short term))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate
Brief Summary: Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.


Options:
A: Percentage of patients with ACR 20 response (Week 24)
B: Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24 (Week 24)
C: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
D: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate
Brief Summary: Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.


Options:
A: Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) (Change of the Mean of DAS28-ESR between weeks 48 - 102.)
B: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
C: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)
D: EULAR Good Response (at 24 weeks); ACR50 Response Rate (at 24 weeks); Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score (at 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate
Brief Summary: Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.


Options:
A: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)
C: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department
Brief Summary: Patients with heroin and prescription opioid dependence are at increased risk for adverse health consequences and often utilize the Emergency Department (ED) as their source of medical care. Screening, brief intervention and referral to treatment has been effective in decreasing high risk behaviors such as alcohol and tobacco use, and unsafe sexual practices. The data on the effectiveness of brief interventions with opioid dependence is limited. This prospective, randomized controlled trial of opioid dependent subjects (N=360) will compare two models of brief intervention with a control condition. ED patients with opioid dependence will be randomized to either: (1)Screening, Brief Intervention with a Facilitated Referral to Treatment (SBIRT); (2) Screening, Brief Intervention with ED initiated Buprenorphine Treatment (SBI+Bup); or (3) standard care (SC) which includes a handout detailing substance abuse treatment centers in the area. The primary outcome will be self-reported engagement in formal substance abuse treatment at 30 days, verified by contact with the treatment program. Other outcomes measured at 30 days, 2, 6 and 12 months include changes in opioid use (self-report and urine toxicology analysis), HIV risk behaviors, and health care service utilization. The three interventions will also be compared on their cost-effectiveness. We will test the hypotheses that SBI+Bup will be superior to SBIRT and SC, and SBIRT will be superior to SC in (1)increasing the proportion of patients engaged in formal substance abuse treatment at 30 days; (2) reducing illicit opioid use; (3) reducing HIV risk behaviors; and (4) reducing health care service utilization. In addition, we hypothesize that the societal costs of SBI+Bup, per number of days of opioid abstinence, will be cost effective relative to SBIRT or SC; and that SBIRT will be cost effective relative to SC. Data analyses will be conducted on the intention to treat sample of randomized patients. This study, conducted by a research team with extensive experience evaluating brief interventions and treatments for opioid dependence, will be unique in its: (1) comparison of two models of brief intervention with standard care; (2) inclusion of an ED initiated treatment arm; (3) use of manual-guided interventions with systematic assessment of adherence and competence; and (4)collection of detailed cost data to help guide future healthcare policy.


Options:
A: Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program) (30 days post randomization)
B: Opiate abstinence
C: Self-reported frequency of illicit opioid use (6 months); Percentage of opioid-negative urine specimens (6 months); Maximum number of weeks abstinent from illicit opioids (6 months)
D: Time to Relapse (Intent to Treat Population) (Weeks 3-24); Time to Relapse (Per Protocol Population) (Weeks 3-24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Metabolic Acidosis and Its Impact on Mineral Metabolism and Physical Performance in Renal Transplant Patients
Brief Summary: Acidosis (accumulation of acid in the body) may be an underrecognized problem in patients after renal transplantation. It may have consequences on physical performance due to negative effects on bone and muscle metabolism.

Therefore, the purpose of this study is

1. to determine the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis
2. to study the effect of substituting base equivalents (citrate) on acid/base status of renal transplant patients with acidosis
3. to compare the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis before and after substitution with citrate


Options:
A: The percentage change in urinary protein to creatinine ratio (UPCR) from baseline to the last measurement during treatment. (baseline and 6 months)
B: N/A
C: The immunologic effects of Vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of: Glomerular filtration rate (one year after kidney transplantation); Number of acute rejection episodes (one year after kidney transplantation); Number of infections (one year after kidney transplantation); CRP levels (one year after kidney transplantation); Courses of calcium levels (within the first year after kidney transplantation)
D: Correction of metabolic acidosis (12 months)

Answer: D