TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate the impact of a a real time teleassistance system in the clinical evolution of type 2 diabetic patients on self monitoring blood glucose in the Public National Primary Care System.


Options:
A: HBA1c Glycosylated hemoglobin (one year for every patient)
B: Hemoglobin A1c (Change from baseline to 6 months)
C: Cardiovascular events (5 years of follow up)
D: Hemoglobin A1c (HbA1c) at 6 Months Post Randomization (6 months post randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate the impact of a a real time teleassistance system in the clinical evolution of type 2 diabetic patients on self monitoring blood glucose in the Public National Primary Care System.


Options:
A: Number of patients with serious adverse events detected during and at the end of an 18 months follow-up period is compared for the two groups (18 months)
B: To what extent does the use of Health Buddy result in a decrease in hospital admissions? (one year); To what extent is Health Buddy® more cost-effective than usual care? (one year); To what extent will the amount of planned contacts decrease without an increase of unplanned contacts? (one year)
C: HBA1c Glycosylated hemoglobin (one year for every patient)
D: Rate of Heart Failure Related (HFR) Hospitalizations (6 months); Freedom From a Device/System-related Complication (DSRC). (6 months); Freedom From Pressure Sensor Failure (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate the impact of a a real time teleassistance system in the clinical evolution of type 2 diabetic patients on self monitoring blood glucose in the Public National Primary Care System.


Options:
A: HBA1c Glycosylated hemoglobin (one year for every patient)
B: Target goal of HbA1c (< 7.0%) without hypoglycemia (24 weeks)
C: Hemoglobin A1c Levels (5 years); Blood Pressure Levels (5 years); Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol (5 years)
D: Hemoglobin A1c (HbA1c)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Randomized, Placebo- Controlled Trial of Vigabatrin for Short Term Abstinence From Cocaine in Cocaine Dependent Parolees
Brief Summary: The primary objective of this study is to assess the efficacy of vigabatrin for the treatment of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine. Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject double- blind, randomized study is designed to show if with vigabatrin treatment but not placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine will become cocaine abstinent if they are self motivated to stop their cocaine habit. To accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase in the number of subjects who are abstinent for the final 3 weeks of the study.


Options:
A: Time to Treatment for Emerging Symptoms of a Mood Relapse (Up to 6 months)
B: Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine). (Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment))
C: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)
D: Proportion of Cocaine Positive Urine Samples Per Treatment Condition (Urine samples collected 3 times weekly from week 1 through 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Randomized, Placebo- Controlled Trial of Vigabatrin for Short Term Abstinence From Cocaine in Cocaine Dependent Parolees
Brief Summary: The primary objective of this study is to assess the efficacy of vigabatrin for the treatment of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine. Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject double- blind, randomized study is designed to show if with vigabatrin treatment but not placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine will become cocaine abstinent if they are self motivated to stop their cocaine habit. To accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase in the number of subjects who are abstinent for the final 3 weeks of the study.


Options:
A: Primary Outcome Measure (3 years)
B: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)
C: Primary Outcome Measure (5 years); Primary Outcome Measure (5 years); Primary Outcome Measure (5 years)
D: Discussion-opportunity about risk of partner abuse during physician-patient medical encounter (audiotaped data); Detection of partner abuse during physician-patient medical encounter (audio taped data)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Randomized, Placebo- Controlled Trial of Vigabatrin for Short Term Abstinence From Cocaine in Cocaine Dependent Parolees
Brief Summary: The primary objective of this study is to assess the efficacy of vigabatrin for the treatment of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine. Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject double- blind, randomized study is designed to show if with vigabatrin treatment but not placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine will become cocaine abstinent if they are self motivated to stop their cocaine habit. To accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase in the number of subjects who are abstinent for the final 3 weeks of the study.


Options:
A: Post-Release Opioid Relapse (Four weeks post-release)
B: Relapse (6 months)
C: CTCR Baseline & Follow-Up Protocol (CTCR Protocol) (Baseline and at 3, 6, 12, and 18 months); Colorado Department of Corrections Record Information System (CDOC-RIS) (At 6, 12, and 18 months); Biological Specimens (At 12 and 18 months); Diagnostic Interview Survey-IV (DIS-IV) (At baseline); Beck Depression Inventory-II (BDI-II) (At baseline and 3, 6, 12, and 18 months); Symptom Checklist 90-R (SCL90-R) (At baseline and 3, 6, 12, and 18 months); Rosenberg Self-Esteem (R-SES) (At baseline and 3, 6, 12, and 18 months); Measures of Social Network (adapted) (At baseline and 3, 6, 12, and 18 months); Client Assessment Inventory (CAI) & Staff Assessment Summary (SAS) (At 3 and 6 months); Therapeutic Community Scale of Essential Elements Questionnaire(SEEQ) (administered monthly over the first six months of the project and quarterly thereafter); Treatment Services Review (TSR) (administered monthly over the first six months of the project and quarterly thereafter); Program Monitoring Form (PMF) (administered monthly over the first six months of the project and quarterly thereafter)
D: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing TVT SECUR System (TVT S) and Trans Vaginal Obturator Tape (TVT-O) for Surgical Management of Stress Urinary Incontinence
Brief Summary: To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.


Options:
A: Objective cure as defined by the cough test at one year from surgery (one year)
B: Subjective cure rate (compared to results of TVT)
C: to assess efficacy between tot with minisling in cure in women with stress urinary incontinence (one year)
D: Percentage of Participants With Negative Cough Stress Test (CST) (four years); Patient Global Impression of Improvement (PGI-I) Score (four years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Prone Positioning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome
Brief Summary: We project to test the effect of prone position on mortality in severe ARDS patients (PaO2/FiO2\<150 with FiO2 \> or = 0.6 and positive end-expiratory pressure \> or = 5 cmH2O). Ventilator will be set in accordance with current standards aiming at protecting the lungs from VALI. Patients will be randomized into two arms: prone group in which proning will be realized for at least 16 hours a day and supine group in which patients will stay in a semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia. Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45% percent, at one-tailed alpha error of 5% and power of 90% and 230 patients are needed in each arm.


Options:
A: Hospital Mortality
B: Physiological variables (i.e. ventilation pressures and oxygenation) during the first 7-10 days following randomization (8-10 days post-randomization); Survival to days 28 and 60 post-randomization and to Hospital Discharge (28 days to more than 60 days post-randomization)
C: 28-day mortality from all causes (28 days)
D: All-cause hospital mortality (Randomised patients will be ventilated according to their assigned ventilation strategy for up to 60 days, until they die on the ventilator or are successfully (for >24 hours) liberated from mechanical ventilation.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Prone Positioning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome
Brief Summary: We project to test the effect of prone position on mortality in severe ARDS patients (PaO2/FiO2\<150 with FiO2 \> or = 0.6 and positive end-expiratory pressure \> or = 5 cmH2O). Ventilator will be set in accordance with current standards aiming at protecting the lungs from VALI. Patients will be randomized into two arms: prone group in which proning will be realized for at least 16 hours a day and supine group in which patients will stay in a semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia. Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45% percent, at one-tailed alpha error of 5% and power of 90% and 230 patients are needed in each arm.


Options:
A: Incidence of ventilator-associated pneumonia (14 days of mechanical ventilation)
B: 28-day mortality from all causes (28 days)
C: Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence (1 minute after Trendelenburg position onset.)
D: Incidence of pre-extubation atelectasis (postoperative 10 minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Prone Positioning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome
Brief Summary: We project to test the effect of prone position on mortality in severe ARDS patients (PaO2/FiO2\<150 with FiO2 \> or = 0.6 and positive end-expiratory pressure \> or = 5 cmH2O). Ventilator will be set in accordance with current standards aiming at protecting the lungs from VALI. Patients will be randomized into two arms: prone group in which proning will be realized for at least 16 hours a day and supine group in which patients will stay in a semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia. Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45% percent, at one-tailed alpha error of 5% and power of 90% and 230 patients are needed in each arm.


Options:
A: Mortality rate (at day 90)
B: 28-day mortality from all causes (28 days)
C: Mortality at 28 days (day 28)
D: Number of Ventilator Free Days at Day 28 Post Randomisation (28 days post randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Prone Positioning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome
Brief Summary: We project to test the effect of prone position on mortality in severe ARDS patients (PaO2/FiO2\<150 with FiO2 \> or = 0.6 and positive end-expiratory pressure \> or = 5 cmH2O). Ventilator will be set in accordance with current standards aiming at protecting the lungs from VALI. Patients will be randomized into two arms: prone group in which proning will be realized for at least 16 hours a day and supine group in which patients will stay in a semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia. Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45% percent, at one-tailed alpha error of 5% and power of 90% and 230 patients are needed in each arm.


Options:
A: Mortality rate (at day 90)
B: N/A
C: 28-day mortality from all causes (28 days)
D: Development of ARDS (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Month Open-label Randomized Parallel Group Study to Investigate the Influence of Salmeterol Xinafoate/Fluticasone Propionate Either in Fixed Combination or Separately Via Diskus Inhalers on the Course of the Disease and Frequency of Exacerbations in Subjects With Severe and Very Severe COPD.
Brief Summary: This is a 12 month randomized, open-label, parallel-group study to obtain data on the frequency and variability of exacerbations in severe and very severe Chronic Obstructive Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III and IV) receiving salmeterol xinafoate and fluticasone propionate either in fixed combination (SFC) or from separate inhalers (Sal/FP) with standard therapy. 200 subjects will be enrolled in approximately 30 study centres in Germany. Data on health care utilisation will be collected to compare direct costs associated with COPD in these two groups.

Baseline data will be collected for all subjects at Visit 1 and eligible subjects will be randomized to receive either SFC 50/500 µg bid (twice daily) as fixed combination or Sal 50 µg bid (twice daily) and FP 500 µg bid (twice daily) concurrently over 52 weeks. Subjects will return for study visits every two to three months until week 52. Additional telephone calls will be made between scheduled visits every 4 weeks. Assessments will include monitoring of frequency of exacerbations, health care utilisation (including emergency visits and hospitalizations) and rescue medication, lung function, drug compliance, health-related quality of life (SGRQ = St George's Respiratory Questionnaire) and safety.


Options:
A: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
C: Mean Number of Exacerbations Per Year: Negative Binomial Model (Baseline through Week 52); Mean Number of Exacerbations Per Year: Poisson Model (Baseline through Week 52)
D: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Month Open-label Randomized Parallel Group Study to Investigate the Influence of Salmeterol Xinafoate/Fluticasone Propionate Either in Fixed Combination or Separately Via Diskus Inhalers on the Course of the Disease and Frequency of Exacerbations in Subjects With Severe and Very Severe COPD.
Brief Summary: This is a 12 month randomized, open-label, parallel-group study to obtain data on the frequency and variability of exacerbations in severe and very severe Chronic Obstructive Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III and IV) receiving salmeterol xinafoate and fluticasone propionate either in fixed combination (SFC) or from separate inhalers (Sal/FP) with standard therapy. 200 subjects will be enrolled in approximately 30 study centres in Germany. Data on health care utilisation will be collected to compare direct costs associated with COPD in these two groups.

Baseline data will be collected for all subjects at Visit 1 and eligible subjects will be randomized to receive either SFC 50/500 µg bid (twice daily) as fixed combination or Sal 50 µg bid (twice daily) and FP 500 µg bid (twice daily) concurrently over 52 weeks. Subjects will return for study visits every two to three months until week 52. Additional telephone calls will be made between scheduled visits every 4 weeks. Assessments will include monitoring of frequency of exacerbations, health care utilisation (including emergency visits and hospitalizations) and rescue medication, lung function, drug compliance, health-related quality of life (SGRQ = St George's Respiratory Questionnaire) and safety.


Options:
A: Mean Number of Exacerbations Per Year: Negative Binomial Model (Baseline through Week 52); Mean Number of Exacerbations Per Year: Poisson Model (Baseline through Week 52)
B: Adverse events (Evaluation at 12 months.)
C: Time to Next Asthma or COPD Exacerbation up to 182 Days (182 days)
D: Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years
Brief Summary: This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years


Options:
A: contraceptive continuation (6 months)
B: Discontinuation rate by treatment group (at 12 months)
C: Pearl Index up to 3 Years (Up to 3 years); Pearl Index for LCS16 up to 5 Years (Up to 5 years)
D: Adherence Rate (Rate of Perfect Method Use) (For the first 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years
Brief Summary: This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years


Options:
A: Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression. (Up to 8 biweekly visits from start of OCP therapy)
B: Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs (Within 60 months); Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs (Within 60 months)
C: Pearl Index up to 3 Years (Up to 3 years); Pearl Index for LCS16 up to 5 Years (Up to 5 years)
D: Pregnancy (AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Childhood Obesity With Family Lifestyle Change
Brief Summary: The purpose of this study is to determine whether an intense family-centered program to help children, 4 to 7 years old, control their weight is more effective than the advise and referrals their health provider gives in the primary care office.


Options:
A: Primary - Body Mass index (2 years)
B: Percent BMI overweight for child and parent (baseline-6,12,18, 24 months)
C: Body mass index (BMI) at 1 year.
D: Child BMI Percentile (2 years after recruitment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre Randomised, Double-blind, Double-dummy Parallel Group Study of the Onset and Offset of Antiplatelet Effects of Ticagrelor Compared With Clopidogrel and Placebo With Aspirin as Background Therapy in Patients With Stable Coronary Artery Disease (CAD)
Brief Summary: The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.


Options:
A: The composite of cardiac death or MI in the intent-to-treat population (1 year after randomization)
B: Primary Outcome The composite of cardio-vascular death, MI, stent thrombosis, TVR and bleeding (minor or major) following randomly assigned DES implantation (12 months after stent implantation)
C: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
D: Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose (At 2 hours after first dose of study drug); Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug (4 to 72 Hours after last dose of study drug)

Answer: D