TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)
Brief Summary: The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP\>=160 mmHg and Diastolic Blood Pressure(DBP)\>=100 mmHg).


Options:
A: Trough Seated Diastolic Blood Pressure (DBP) Control (End of study (34 weeks or last value on treatment))
B: Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 (Baseline and Week 7)
C: Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy (End of trial follow-up); Change in blood pressure (End of trial follow-up); Change in LDL cholesterol (End of trial follow-up)
D: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepped Care to Optimize Pain Care Effectiveness (SCOPE)
Brief Summary: Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Pain is particularly prevalent among veterans. Four major barriers to optimal care include underdetection of pain, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary care.


Options:
A: HbA1c (3 months)
B: Change in medication adherence (Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months); Change in number of hospitalizations (costs) (Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months)
C: Hemoglobin A1c
D: Brief Pain Inventory (Pain) (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepped Care to Optimize Pain Care Effectiveness (SCOPE)
Brief Summary: Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Pain is particularly prevalent among veterans. Four major barriers to optimal care include underdetection of pain, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary care.


Options:
A: Brief Pain Inventory (Pain) (1 year)
B: Rate of all-cause hospital readmission or death during the 6-month follow-up period. (6 months)
C: The Generalised Anxiety Disorder 7-item (GAD-7) (Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.)
D: Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer. (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepped Care to Optimize Pain Care Effectiveness (SCOPE)
Brief Summary: Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Pain is particularly prevalent among veterans. Four major barriers to optimal care include underdetection of pain, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary care.


Options:
A: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)
B: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
C: Brief Pain Inventory (Pain) (1 year)
D: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus
Brief Summary: There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there is still a need of new treatments that can reduce considerably the tinnitus symptoms and improve the QOL of subjects.

Trial objectives:

* The aim of this trial is the improvement of the QOL (quality of live) by reducing the Tinnitus- Symptoms of the patient.
* To confirm the efficacy and safety of the coordinated reset technology.

These objectives will be assessed:

* By subjective and objective measurements of the Tinnitus symptoms, loudness and annoyance.


Options:
A: Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; German version: Kleinjung et al., 2007) (18 months); MINI-Tinnitus Questionnaire (Mini-TQ; Hiller & Goebel, 2004) (18 months)
B: N/A
C: The Tinnitus Functional Index (Assessed at baseline and 8 weeks post-intervention)
D: Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005) (Last session)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus
Brief Summary: There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there is still a need of new treatments that can reduce considerably the tinnitus symptoms and improve the QOL of subjects.

Trial objectives:

* The aim of this trial is the improvement of the QOL (quality of live) by reducing the Tinnitus- Symptoms of the patient.
* To confirm the efficacy and safety of the coordinated reset technology.

These objectives will be assessed:

* By subjective and objective measurements of the Tinnitus symptoms, loudness and annoyance.


Options:
A: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (At baseline and 3, 8 and 12 months follow-up)
B: THI (3 months)
C: Tinnitus Handicap Questionnaire (4 weeks)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A+ Head Start Intervention for Smoke Free Homes
Brief Summary: Environmental tobacco smoke (ETS0, also known as secondhand smoke, is the combination of smoke given off by the burning end of a tobacco product and the smoke exhaled by the smoker. Children exposed to ETS are at an increased risk of sudden infant death syndrome (SIDS), ear infections, colds, pneumonia, bronchitis and more severe asthma. ETS can also slow the growth of children's lungs and can cause them to cough, wheeze and fell breathless. The purpose of this study is to determine the effectiveness of a motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in a Head Start program and whose households include a smoker.


Options:
A: 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
B: Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study (4 yrs)
C: 7-day point prevalence abstinence from smoking (6 months after enrollment)
D: Air Nicotine Levels (Measured at Baseline, 3, 6 and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A+ Head Start Intervention for Smoke Free Homes
Brief Summary: Environmental tobacco smoke (ETS0, also known as secondhand smoke, is the combination of smoke given off by the burning end of a tobacco product and the smoke exhaled by the smoker. Children exposed to ETS are at an increased risk of sudden infant death syndrome (SIDS), ear infections, colds, pneumonia, bronchitis and more severe asthma. ETS can also slow the growth of children's lungs and can cause them to cough, wheeze and fell breathless. The purpose of this study is to determine the effectiveness of a motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in a Head Start program and whose households include a smoker.


Options:
A: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))
B: Air Nicotine Levels (Measured at Baseline, 3, 6 and 12 months)
C: Child Urine Cotinine (up to 12 months); Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources (up to 12 months)
D: The level of exposure to SHS in the babies by means of questionnaire and nicotine hair analysis. (6 months at the beginning of intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Evaluation of the Effectiveness of Lithium in Subjects With Treatment-Resistant Depression and Suicide Risk. An Independent, Pragmatic, Multicentre, Parallel-Group, Superiority Trial
Brief Summary: The principal clinical question is whether lithium is effective in reducing the risk of suicidal behaviour in subjects with treatment-resistant depression and suicide risk. Additionally aims of the study are: (a) to assess whether lithium is effective in improving depressive symptomatology in subjects with treatment-resistant depression and suicide risk; (b) to assess the tolerability profile of lithium.


Options:
A: Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set) (6 weeks treatment); Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set) (6 weeks of treatment)
B: MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate (12 weeks)
C: Suicide completion and acts of deliberate self harm (DSH) will constitute the composite primary outcome (One year)
D: Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample. (Baseline and Week 14); Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol. (Baseline and Week 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency
Brief Summary: Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.


Options:
A: Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) (From randomization up to the end of the treatment period (minimum of 6 months))
B: major bleeding (up to 48 hours from last injection)
C: Composite of all strokes and non-CNS systemic embolism.
D: Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters (Day 183); Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion (Day 183 to Day 188)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Clinical Impact of Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin in Patients Being Initiated on Oral Anticoagulation
Brief Summary: The purpose of this study is to determine whether DNA analysis improves the efficiency of dosing and safety in patients who are being started on warfarin therapy.Warfarin, a blood thinner (anticoagulant) prescribed to 1-2 million patients in the United States, is a leading cause of drug-related adverse events (e.g., severe bleeding), in large part due to dramatic (20-fold) differences between individuals in dose requirements. At least half of this variability now can be explained by 3 common genetic variants, age, body size, and sex; however, warfarin therapy continues to begin with the same dose in every patient with the correct individual dose determined by trial and error. This study proposes to determine genetic variations the same day from DNA simply obtained by swabbing the inside of the cheek and use this information to determine the proper dose regimen individually in each patient. The aim is to show that the investigators can achieve more rapid, efficient, and safe dosing in up to 500-1000 individuals who are initiating warfarin therapy for various clotting disorders across a large healthcare system in order to demonstrate improved dosing effectiveness, efficiency, and safety with genetic-based dosing, which could lead to a nationwide application resulting in as much as a $1 billion dollar annual benefit in healthcare outcomes.


Options:
A: The Percent of Out of Range (OOR) International Normalized Prothrombin Time Ratio (INRs) in the Standard and Modified Pharmacogenetic Arms. (1 month (from day 3 to day 30)); The Percent of Out of Range (OOR) INRs in Pharmacogenetic-guided Patients and Parallel Controls (1 month (from day 3 to day 30)); The Percent of Time in Therapeutic Range (TTR) for the Standard and Modified Pharmacogenetic Algorithms. (1 month (from baseline to day 30)); The Time in Therapeutic Range (TTR) for the Pharmacogenetic-guided Patients and Parallel Controls (1 month (from baseline to day 30))
B: Number of mature follicles in the study and control group.
C: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
D: rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period (after 30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Vulnerable Elderly Patients With Overactive Bladder.
Brief Summary: This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).


Options:
A: Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
B: Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours (Baseline); Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)
C: Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome (Weeks 1, 4, 8 and 12)
D: Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours (Baseline and EoT (up to 12 weeks)); Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours (Baseline and EoT (up to 12 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Study of Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Hospitalized Patients With Exacerbation of Cystic Fibrosis
Brief Summary: Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt concentration has been shown to increase activity of salt sensitive antimicrobial peptides.

Xylitol is a 5-carbon sugar that can lower the ASL salt concentration, thus enhancing innate immunity. In this study, the investigators propose to test the safety and tolerability of aerosolized xylitol used daily for 2 weeks in subjects with cystic fibrosis. In a pilot, 2-week study, 60 subjects with cystic fibrosis with an FEV1(Forced expiratory volume in 1 second ) \>30% predicted will be randomized to receive aerosolized 7% hypertonic saline (5 ml) or 15% xylitol, (5 ml) twice a day for 14 days. The primary outcomes will be safety as assessed by FEV1 change from baseline, adverse events and respiratory symptom score. Outcomes for trend in efficacy include density of colonization of sputum, time to next exacerbation, sputum cytokines and revised CF quality of life questionnaire.


Options:
A: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)
B: Percent Mucociliary Clearance at 60 Minutes (60 minutes)
C: Change in FEV1 Percentage Predicted From Baseline (14 days)
D: Interview #1 (to be conducted at the time of enrollment (post SIMPLIFY study)); Interview #2 (to be conducted 4 months following the date of the first interview)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation
Brief Summary: This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.


Options:
A: Changes in 24-hour micturition frequency (Bladder diaries completed at recruitment and 6 weeks, 12 weeks and 6 months.)
B: Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline (36 months total)
C: Frequency of Voids at 12 Weeks (Baseline to 12 weeks)
D: The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis. (13 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind (Sponsor Open), Placebo Controlled, Dose Escalating, Parallel Group, Multi-Centre Study To Investigate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous/Sub-Cutaneous Doses Of PF-00547659 In Patients With Active Ulcerative Colitis.
Brief Summary: study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis


Options:
A: Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) (Week 12 (Day IP-85)); Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 (Month 12 (Day MP-365)); Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation (Day OL-1 through the end of the OL); OL; Number of Participants With AEs of Special Interest (Day OL-1 through Day OL-729); OL; Number of Participants With Physical Examination Findings (Day OL-1 through Day OL-729); OL; Number of Participants With Marked Hematology Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities (Day OL-1 through Day OL-729)
B: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
C: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)
D: Safety and toleration (up to 12 weeks); Endoscopic score changes as calculated using section 3 of the Mayo Score (up to 12 weeks); Disease activity score changes as calculated using the Mayo Score (up to 12 weeks)

Answer: D