TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension
Brief Summary: In Patients with rheumatic disease exercise training is a well established element of therapy. In contrast patients with severe pulmonary hypertension are advised to avoid physical exertion and must not perform exercise training. This study aims to evaluate the effectivity and safety of a low-dose training program in patients with pulmonary hypertension and rheumatic disease.


Options:
A: Functional exercise capacity (Oxygen consumption measurement during test) (6 weeks)
B: changes in 6-Minute Walk Distance (6MWD) (baseline and week 4)
C: Change in the 6-minute walking distance (after 3 weeks and after 15 weeks compared to baseline.); Quality of life (SF-36) (baseline and 15 weeks)
D: Pulmonary artery systolic pressure (PASP) (change from baseline at 12 weeks); Subjective self-report questionnaire that assesses sleep quality (change from baseline at 12 weeks); Determining sleep patterns (change from baseline at 12 weeks); Measuring aerobic fitness (change from baseline at 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension
Brief Summary: In Patients with rheumatic disease exercise training is a well established element of therapy. In contrast patients with severe pulmonary hypertension are advised to avoid physical exertion and must not perform exercise training. This study aims to evaluate the effectivity and safety of a low-dose training program in patients with pulmonary hypertension and rheumatic disease.


Options:
A: Six minute walking distance (3 months); New York Heart Association (NYHA) functional class (3 months)
B: Change in the 6-minute walking distance (after 3 weeks and after 15 weeks compared to baseline.); Quality of life (SF-36) (baseline and 15 weeks)
C: distance walked in 6 minutes (baseline - 15 weeks afterwards); change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire (baseline - 15 weeks afterwards)
D: Survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Multi-Center, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess the Antidepressant Effect and Onset of Effect of AZD6765 in Treatment-Resistant Major Depressive Disorder Patients
Brief Summary: The purpose of this study is to determine whether treatment with AZD6765 will have an antidepressant effect with patients who have treatment resistant depression.


Options:
A: The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score. (Change from Baseline)
B: Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2) (Last Observation Carried Forward [LOCF] Data) During Double-blind Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2))
C: Level of Depression as assessed by the HAM-D (Day 1-7)
D: Episodes of Depression or Elation (15 months (duration of trial and 3 month follow-up))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Multi-Center, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess the Antidepressant Effect and Onset of Effect of AZD6765 in Treatment-Resistant Major Depressive Disorder Patients
Brief Summary: The purpose of this study is to determine whether treatment with AZD6765 will have an antidepressant effect with patients who have treatment resistant depression.


Options:
A: Memory tests (Before ECT, after 6 ECT treatments, at the end of the ECT course)
B: qEEG assessed through the gamma bands (Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h)
C: Observed and laboratory-confirmed safety (four weeks)
D: The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score. (Change from Baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Effects of a Single Dose of Sildenafil (20mg/40mg) on Pulmonary Haemodynamics and Gas Exchange at Rest and During Exercise in COPD Patients With Pulmonary Hypertension
Brief Summary: Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), we hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition. However, in COPD sildenafil may also impair gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. The research project is aimed to evaluate these effects.

It is a prospective, randomized, double-blind study to evaluate the acute effects of a single dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. Subjects: 20 patients (10 in each group). Measurements: pulmonary hemodynamics, arterial blood gasses and ventilation-perfusion distributions; at rest and during sub-maximal exercise.


Options:
A: Change in 6-minute Walk Test (0 - 6 months)
B: Pulmonary Artery Systolic Pressure (PASP)
C: Reduction of mean PAP and PVR (60 minutes)
D: Time to First Confirmed Morbidity/Mortality Event up to the End of Study (From baseline to end of study, approximately 86 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga for Women Attempting Smoking Cessation: an Initial Investigation
Brief Summary: The purpose of this study is to examine the feasibility, acceptability and initial effectiveness of adding yoga to a traditional, group-based treatment for smoking cessation for women smokers.


Options:
A: smoking cessation: 7-day point prevalence abstinence (6 months)
B: Number of Participants With Smoking Abstinence (4 weeks post quit day (one week following the end of treatment)); Smoking Abstinence (26 weeks post quit day); Smoking Abstinence (4 weeks post quit day (one week following the end of treatment))
C: Smoking Abstinence (6 months post quit day)
D: Number of Participants Who Stopped Smoking by 12 Month Post Treatment (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga for Women Attempting Smoking Cessation: an Initial Investigation
Brief Summary: The purpose of this study is to examine the feasibility, acceptability and initial effectiveness of adding yoga to a traditional, group-based treatment for smoking cessation for women smokers.


Options:
A: Negative Affect (1-week Post-Intervention Smoking Context); Negative Affect/Withdrawal (1-week Post-Intervention Smoking Context); N-Back Task (1-week Post-Intervention Smoking Context); Spatial Span (1-week Post-Intervention Smoking Context); Digit Span (1-week Post-Intervention Smoking Context); Anxiety Sensitivity (1-week Post-Intervention Smoking Context); Mirror-Tracing Persistence Task (1-week Post-Intervention Smoking Context); Negative Affect (1week+2days Post-Intervention Deprivation Context); Negative Affect/Withdrawal (1week+2days Post-Intervention Deprivation Context); N-Back Task (1week+2days Post-Intervention Deprivation Contex); Spatial Span (1week+2days Post-Intervention Deprivation Contex); Digit Span (1week+2days Post-Intervention Deprivation Context); Anxiety Sensitivity (1week+2days Post-Intervention Deprivation Contex); Mirror-Tracing Persistence Task (1week+2days Post-Intervention Deprivation Context)
B: 7-day point prevalence (3 months and 6 months post treatment)
C: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
D: smoking cessation: 7-day point prevalence abstinence (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: 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)
B: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
C: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
D: Long term abstinence (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
B: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
C: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
D: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: Smoking Behavior (Nine weeks)
B: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
C: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
D: Cigarette use (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
B: N/A
C: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)
D: 7 day point prevalence of cigarette abstinence (End of trial (week 10))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
B: Continuous Nicotine Abstinence (8 weeks)
C: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
D: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: Tobacco use abstinence (26 week)
B: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
C: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
B: tobacco abstinence (6 months)
C: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
D: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
B: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
C: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
B: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
C: The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date)
D: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
B: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)
C: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
D: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Adjunctive Treatment in Schizophrenia
Brief Summary: The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.


Options:
A: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
B: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
C: 4-week continuous quit rate (CQR) for Weeks 9-12
D: 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).

Answer: A