TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Seroquel XR for the Management of Borderline Personality Disorder (BPD)
Brief Summary: The Primary objective of this study is to evaluate Seroquel XR in the treatment of borderline personality disorder (BPD). As in many initial randomized control trials, the study will be of relatively short duration - 8 weeks - to assess effectiveness and safety while maximizing retention. The specific aim is to determine if Seroquel XR is superior to placebo. The primary outcome measure will be a statistically significant difference between Seroquel XR compared to placebo on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD), an objective rating scale that addresses the severity of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of the illness. As there is the recent development of an extended release form of Seroquel (Seroquel XR) (Schulz et al. 2007), the new compound may offer several advantages in this study. Therefore, the hypothesis of this study is that both doses of Seroquel XR (see below) will be superior to placebo in an 8-week randomized trial as assessed by the ZAN-BPD.

To achieve the Primary Objective of this study, two doses of Seroquel XR will be tested - 150 mg/d and 300 mg/d. Thus, the study will be able to assess the effect of Seroquel XR compared to placebo and to explore a dose effect.


Options:
A: Suicidal behavior and ideation (Weeks 4, 12, and 24)
B: Parasuicidal behaviour (intermittent)
C: Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (baseline, weekly until week 8); Montgomery-Åsberg Depression Rating Scale (MADRS) (baseline to 8 weeks); Borderline Evaluation of Severity Over Time (BEST) (Baseline to 8 weeks); Overt Aggression Scale - Modified (OAS-M) (Change from Baseline Overt Aggression Scale - Modified to 8 weeks); Global Assessment of Functioning Scale (GAF) (Change in Global Assessment of Functioning from Baseline to 8 weeks); Barratt Impulsiveness Scale (BIS) (Change in Impulsiveness from Baseline to 8 weeks); Symptom Checklist -90-Revised (SCL-90-R) (Change in psychological problems and symptoms from Baseline to 8 weeks); Young Mania Rating Scale (YMS) (Change in manic symptoms from Baseline to 8 weeks); Sheehan Disability Scale (SDS) (Change in functional impairment from Baseline to 8 weeks)
D: Borderline Symptoms (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylaxis of Venous Thromboembolism in Patients With a Nonsurgical Fracture of the Lower Extremity Immobilised in a Below-Knee Plaster Cast
Brief Summary: Objective:

The purpose of this study is to determine the need for thromboprophylaxis in patients with a fracture of the lower extremity being treated conservatively in a below-knee plaster cast and to assess if both of the two tested prophylactic treatments are effective for this indication.

Hypothesis:

Nadroparine and Fondaparinux are both effective in preventing a thromboembolic event in patients with a nonsurgical fracture of a lower extremity immobilised in a below-knee plaster cast.


Options:
A: To evaluate the effect of LMWH (Fragmin, dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound (While in ICU to a maximum of 90 days)
B: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
C: Clinically important venous thromboembolism at 3 months
D: Primary outcome measure is deep vein trombosis as detected by venous duplex (subjects are assessed after 6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients
Brief Summary: The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.


Options:
A: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 weeks)
B: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy (Baseline, Week 24); Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy (Baseline, Week 24)
C: Hypoglycaemic Events (78 weeks plus 1 week of follow-up); Change From Baseline to Week 78 in Lipid Parameters (Weeks 1 and 78); Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements (78 weeks plus 1 week of follow-up)
D: New onset of hypertension (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Treatment of Insomnia in Posttraumatic Stress Disorder
Brief Summary: This study will test the effectiveness of cognitive behavioral therapy for insomnia in treating sleep disturbances in people with post-traumatic stress disorder.


Options:
A: Sleep Latency (SL) (After 8 weeks of study participation); Minutes of Wake After Sleep Onset (WASO) (After 8 weeks of study participation); Sleep Efficiency (SE) (After 8 weeks of study participation)
B: Composite Abuse Scale (CAS)-CAS Victimization Total Score (Assessed at baseline, and again three months later); Safety Behavior Checklist (SBC) (Assessed at baseline, and again three months later); Effectiveness in Obtaining Resources Scale (EOR) (Assessed at baseline, and again three months later)
C: Change in PTSD symptoms (PTSD Symptom Scale Interview) (Change in PTSD symptoms from baseline to 3 months post intervention)
D: Depression symptoms; measured immediately post-treatment and 6 months post-treatment; Post-traumatic stress disorder symptoms; measured immediately post-treatment and 6 months post-treatment

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction
Brief Summary: The purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction.


Options:
A: incidence of acute kidney injury (change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5)
B: Creatinine kinase (CK), creatinine kinase-MB (CK-MB) (4hr, 8hr, 12hr, 24hr, 48hr, 72hr)
C: In-stent Neointimal volume; In-stent Late lumen loss; Semi-Quantitative evaluation of infarcted size of myocardium
D: change of left ventricular ejection fraction measured by cardiac MRI (6, 12, and 24month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia
Brief Summary: This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.


Options:
A: hemoglobin variability (2 years)
B: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) (Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24)
C: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period (EEP (Week 17 to Week 24))
D: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Pulmonary Rehabilitation in Interstitial Lung Diseases: a Prospective Randomized Controlled Trial
Brief Summary: Treatment in interstitial lung diseases (ILD) is frequently ineffective. Pulmonary rehabilitation (PR) is an excellent therapeutic option in another chronic lung diseases such as chronic obstructive pulmonary disease (COPD). This prospective randomized controlled study aims to evaluate the short and long-term effects of PR in patients with ILD. For this purpose, 60 ILD patients will be randomly assigned to a PR or a control group.

The investigators hypothesize that PR will improve exercise capacity, increase muscle force, reduce dyspnea and improve quality of life and daily life activities in ILD patients.


Options:
A: changes in six minute walking distance after 6 months (6 months)
B: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks (52 weeks)
C: Annual Rate of Decline in Forced Vital Capacity - Overall Population (Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)); Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only (Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits))
D: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks. (52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)- A Randomized Controlled Parallel Intervention Trial.
Brief Summary: The purpose of this study is to investigate the role of EMS as a preventive and therapeutic tool of CIPNM. The investigators hypothesized that EMS will prevent the development of CIPNM or have a beneficial role as a therapeutic means in case of CIPNM appearance.


Options:
A: Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity) (1 week)
B: Diagnosis of CIPNM (June 2009)
C: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)
D: Incremental shuttle walk test (10 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)- A Randomized Controlled Parallel Intervention Trial.
Brief Summary: The purpose of this study is to investigate the role of EMS as a preventive and therapeutic tool of CIPNM. The investigators hypothesized that EMS will prevent the development of CIPNM or have a beneficial role as a therapeutic means in case of CIPNM appearance.


Options:
A: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)
B: Diagnosis of CIPNM (June 2009)
C: Morbidity and mortality after open infrarenal aortic aneurysm repair (2 years)
D: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)- A Randomized Controlled Parallel Intervention Trial.
Brief Summary: The purpose of this study is to investigate the role of EMS as a preventive and therapeutic tool of CIPNM. The investigators hypothesized that EMS will prevent the development of CIPNM or have a beneficial role as a therapeutic means in case of CIPNM appearance.


Options:
A: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
B: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)
C: Diagnosis of CIPNM (June 2009)
D: mortality

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects
Brief Summary: The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA \[less than 25 IU per mL undetectable\] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.


Options:
A: Safety and Tolerability (40 weeks)
B: Number of Participants With Sustained Virologic Response (SVR) (From follow-up week (FW) 24 up to end of follow-up (EOF))
C: The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72) (Week 72)
D: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) (Weeks 4 and 12); Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24) (Follow-up Week 24); Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died (From start of study treatment (day 1) up to follow-up Week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)
Brief Summary: Scleroderma is a rare, long-term autoimmune disease in which normal tissue is replaced with dense, thick fibrous tissue. Normally, the immune system helps defend the body against disease and infection. In people with scleroderma, the immune system triggers fibroblast cells to produce too much of the protein collagen. The extra collagen becomes deposited in the skin and organs, causing hardening and thickening that is similar to the scarring process. Although scleroderma most often affects the skin, it also can affect other parts of the body, including the lungs, and in its most severe forms scleroderma can be life-threatening. Scleroderma-related interstitial lung disease is one example of a life-threatening scleroderma condition. In people with symptomatic scleroderma-related interstitial lung disease, scarring occurs in the delicate lung tissue, compromising lung function. The purpose of this study is to determine whether people with symptomatic scleroderma-related interstitial lung disease experience more respiratory benefits from treatment with a 2-year course of mycophenolate mofetil or treatment with a 1-year course of oral cyclophosphamide.


Options:
A: Time to Treatment Failure (12 months); Disease Improvement (12 months)
B: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value (Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24)
C: Forced Vital Capacity (12 months)
D: Global Rank Composite Score (GRCS) (Month 54, ITT) (54 Months Post-Randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)
Brief Summary: Scleroderma is a rare, long-term autoimmune disease in which normal tissue is replaced with dense, thick fibrous tissue. Normally, the immune system helps defend the body against disease and infection. In people with scleroderma, the immune system triggers fibroblast cells to produce too much of the protein collagen. The extra collagen becomes deposited in the skin and organs, causing hardening and thickening that is similar to the scarring process. Although scleroderma most often affects the skin, it also can affect other parts of the body, including the lungs, and in its most severe forms scleroderma can be life-threatening. Scleroderma-related interstitial lung disease is one example of a life-threatening scleroderma condition. In people with symptomatic scleroderma-related interstitial lung disease, scarring occurs in the delicate lung tissue, compromising lung function. The purpose of this study is to determine whether people with symptomatic scleroderma-related interstitial lung disease experience more respiratory benefits from treatment with a 2-year course of mycophenolate mofetil or treatment with a 1-year course of oral cyclophosphamide.


Options:
A: Absolute Change in Percent Predicted Forced Vital Capacity (FVC) (From baseline up to 72 weeks)
B: Absolute Change in Percent Predicted Forced Vital Capacity(FVC) (Baseline to week 72)
C: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value (Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24)
D: Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period
Brief Summary: Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis \[MS\].

Secondary objectives were:

* To assess the effect of the two doses in comparison to interferon beta-1a on:

  * Frequency of relapses,
  * Fatigue,
  * Participant's satisfaction with treatment.
* To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a.

The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.


Options:
A: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
B: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
C: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain (Week 12 to Week 24)
D: ARR - PDEs (Baseline to Month 36)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period
Brief Summary: Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis \[MS\].

Secondary objectives were:

* To assess the effect of the two doses in comparison to interferon beta-1a on:

  * Frequency of relapses,
  * Fatigue,
  * Participant's satisfaction with treatment.
* To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a.

The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.


Options:
A: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)
B: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
C: Number of patients with adverse events (Up to a maximum of 532 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives)
D: Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS) (Up to a maximum of 108 weeks depending on time of enrollment)

Answer: B