TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Effectiveness of 5 Artemisinin Combination Treatment Regimens in the Treatment of Uncomplicated Falciparum Malaria
Brief Summary: Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region.

Artemisinin-based combination therapy is now the recommended treatment for uncomplicated falciparum malaria. The success of this policy change in practice will depend on the efficacy of the components of the combination used, the population coverage achieved, high levels of adherence to treatment, low cost of the drugs, and preferably the drugs in a combination treatment should be formulated in a single tablet, to prevent one drug being taken without the partner drug. Until recently there were only two artemisinin-based fixed combinations available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former has international registration. More fixed combinations are needed urgently.


Options:
A: Cure rate (63 days)
B: To determine the clinical efficacy of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) in the treatment of uncomplicated falciparum malaria in children living in north-western Tanzania and in western Kenya. (during 42 day follow-up)
C: Overall Cure Rate at Day 42
D: PCR unadjusted treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping. (Day 28); PCR adjusted treatment failure up to day 28 (TF28A): all early failures before day 14 plus the recurrent parasitaemias detected at day 14 or later and classified by genotyping as recrudescence. (Day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Effectiveness of 5 Artemisinin Combination Treatment Regimens in the Treatment of Uncomplicated Falciparum Malaria
Brief Summary: Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region.

Artemisinin-based combination therapy is now the recommended treatment for uncomplicated falciparum malaria. The success of this policy change in practice will depend on the efficacy of the components of the combination used, the population coverage achieved, high levels of adherence to treatment, low cost of the drugs, and preferably the drugs in a combination treatment should be formulated in a single tablet, to prevent one drug being taken without the partner drug. Until recently there were only two artemisinin-based fixed combinations available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former has international registration. More fixed combinations are needed urgently.


Options:
A: Crude Cure Rate on Day 14 (Day 14)
B: Proportion of patients with parasitological cure up to day 28 after treatment (defined as clearance of circulating vivax parasites by day 7 and absence until end of follow-up).
C: Cure rate (63 days)
D: parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) (June 2008)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions.
Brief Summary: The purpose of this multi-center study is to determine the efficacy and safety of Mucograft® in combination with the coronally advanced flap (CAF) for the treatment of gingival recessions. It is assumed that the CAF combined with Mucograft® will result in improved outcome in terms percentage of root coverage and soft tissue thickness in comparison to CAF alone (control).


Options:
A: Percentage of root coverage (6 months)
B: Percentage of root coverage (6 months)
C: Percentage of Defect Coverage (6 months)
D: percentage of root coverage (6 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Adherence Intervention After ACS Hospitalization
Brief Summary: We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by helping veterans take their medications routinely as prescribed, the quality of cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been associated with improved outcomes, and the efficiency of care by using telephone calls and tele-monitoring for communication with patients rather than clinic visits. The findings of the study will address an important gap in knowledge (i.e., how to improve adherence to medications following ACS discharge) and will be generalizable to other VA Medical Centers and veterans.


Options:
A: Health literacy levels (Measured at Week 6 and Months 6, 12, 18, and 24); Blood pressure control (Measured at Week 6 and Months 6, 12, 18, and 24); Reduction in blood pressure (Measured at Month 24)
B: Safety: All-cause mortality (6 weeks); Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion (6 weeks); Feasibility: Proportion of patients in the intervention group discharged within 72 hours ("feasible" if >= 70%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge ("feasible" if >= 80%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge ("feasible" if >= 90%)
C: Readmissions (30 days); Admissions (180 days); Emergency Department Visits (180 days); Composite Endpoint, Admissions or Emergency Department Visits (180 days)
D: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Adherence Intervention After ACS Hospitalization
Brief Summary: We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by helping veterans take their medications routinely as prescribed, the quality of cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been associated with improved outcomes, and the efficiency of care by using telephone calls and tele-monitoring for communication with patients rather than clinic visits. The findings of the study will address an important gap in knowledge (i.e., how to improve adherence to medications following ACS discharge) and will be generalizable to other VA Medical Centers and veterans.


Options:
A: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
B: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)
C: BP at 6 months (6 months)
D: Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin) (6 months post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Adherence Intervention After ACS Hospitalization
Brief Summary: We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by helping veterans take their medications routinely as prescribed, the quality of cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been associated with improved outcomes, and the efficiency of care by using telephone calls and tele-monitoring for communication with patients rather than clinic visits. The findings of the study will address an important gap in knowledge (i.e., how to improve adherence to medications following ACS discharge) and will be generalizable to other VA Medical Centers and veterans.


Options:
A: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)
B: Adherence to the decision to use or not to use statins
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: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Adherence Intervention After ACS Hospitalization
Brief Summary: We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by helping veterans take their medications routinely as prescribed, the quality of cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been associated with improved outcomes, and the efficiency of care by using telephone calls and tele-monitoring for communication with patients rather than clinic visits. The findings of the study will address an important gap in knowledge (i.e., how to improve adherence to medications following ACS discharge) and will be generalizable to other VA Medical Centers and veterans.


Options:
A: Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients
B: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)
C: The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption. (July 2006-July 2009)
D: Modified Medication Possession Ratio (Measured over 19 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Adherence Intervention After ACS Hospitalization
Brief Summary: We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by helping veterans take their medications routinely as prescribed, the quality of cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been associated with improved outcomes, and the efficiency of care by using telephone calls and tele-monitoring for communication with patients rather than clinic visits. The findings of the study will address an important gap in knowledge (i.e., how to improve adherence to medications following ACS discharge) and will be generalizable to other VA Medical Centers and veterans.


Options:
A: Blood Pressure Change (Measured at Baseline, and 6,12,18,24, and 30 months post baseline.)
B: Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm). (96 weeks)
C: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)
D: Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Centered Adherence Intervention After ACS Hospitalization
Brief Summary: We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by helping veterans take their medications routinely as prescribed, the quality of cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been associated with improved outcomes, and the efficiency of care by using telephone calls and tele-monitoring for communication with patients rather than clinic visits. The findings of the study will address an important gap in knowledge (i.e., how to improve adherence to medications following ACS discharge) and will be generalizable to other VA Medical Centers and veterans.


Options:
A: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)
B: Total Number of Medications (Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC)
C: Drug Related Problems (DRP) (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Mortality (6-month after inclusion); Average length of the hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Readmissions (6-month after inclusion); Average cost of hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days)
D: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder: PRopiverine Study on Overactive Bladder Including Urgency Data (PROUD)
Brief Summary: Overactive bladder (OAB) is defined as "urgency, with or without urge incontinence, usually with frequency and nocturia" in the absence of local pathological or endocrine factors. Urgency is defined as "the complaint of a sudden compelling desire to pass urine that is difficult to defer" and an abnormal sensation that is distinctly different from the normal physiologic feeling of 'urge to void' that occurs during typical bladder-filling cycles.

Because up to 50% of patients with OAB experience urgency without incontinence, and because urgency is the most bothersome symptom that drives behavioral adaptations such as frequent voiding because of the very fear of urgency, this is the cornerstone symptom of OAB that indicates the diagnosis of OAB.

Even though any effective treatment for OAB must reduce the patient's sense of urgency, its subjective nature makes it difficult to measure. Therefore, the clinical efficacy of OAB treatment was traditionally measured in terms of objective surrogate parameters instead of urgency itself: for example, change in urinary frequency, incontinent episodes, number of pads and urodynamically proven detrusor overactivity, which could be measured easily and quantifiably.

Recently, several methods that measure urgency have been developed and used in clinical practice. However, the analysis questioned the clinical significance of the results; a possible reason for this being the lack of data based on urinary urgency and the use of sensitive patient-driven criteria.

Propiverine hydrochloride (1-methyl-4-piperidyl diphenylpropoxyacetate hydrochloride) is a drug with combined antimuscarinic and calcium antagonistic actions. Previous trials on the clinical efficacy and safety of propiverine for treating patients with OAB have reported improvements in urinary frequency and incontinence, but not in urgency.

The aim of this study was to explore the efficacy of a daily regimen of propiverine at 20 mg (immediate release formulation) in improving urgency from baseline to 12 weeks of treatment in patients with OAB.


Options:
A: Change From Baseline to Week 12 in Bladder Wall Thickness (Baseline and Week 12); Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12 (Week 12)
B: Percent change in mean number of urgency episode (12 weeks of treatment)
C: Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.
D: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of RAD001 as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line RAD001 in the Treatment of Patients With Metastatic Renal Cell Carcinoma.
Brief Summary: This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.


Options:
A: Progression Free Survival (PFS) (From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 3 years)
B: Progression-free Survival (PFS) (From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months)
C: Progression Free Survival (PFS) (Randomization to Measured Progressive Disease or Date of Death From Any Cause (Up to 67 Months))
D: Progression Free Survival First-Line (PFS 1-L) (based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of RAD001 as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line RAD001 in the Treatment of Patients With Metastatic Renal Cell Carcinoma.
Brief Summary: This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.


Options:
A: Overall Survival (OS) (Baseline up to Month 80)
B: Progression Free Survival (PFS) (From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months))
C: Duration of Progression-Free Survival (PFS) per RECIST 1.1 as determined by blinded independent radiology committee (BIRC) (Up to 23 months after first subject randomized)
D: Progression Free Survival First-Line (PFS 1-L) (based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients With Cystic Fibrosis.
Brief Summary: The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis


Options:
A: The Safety and Tolerability of a Single-dose of KB001. (Day 28)
B: Change in Sputum Myeloperoxidase (MPO) Level (Baseline (Visit 2) to Week 16 (Visit 4))
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) (Up to Follow-up (up to 42 days)); Number of Participants With Vital Signs of Potential Clinical Importance (Up to Follow-up (up to 42 days)); Number of Participants With Hematology Abnormalities of Potential Clinical Importance (Up to Follow-up (up to 42 days)); Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (Up to Follow-up (up to 42 days)); Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Up to Follow-up (up to 42 days)); Number of Participants With Cystic Fibrosis (CF) Exacerbation (Day 1 to Day 42)

Answer: D