TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine -Atorvastatin Combination In Subjects With Hypertension and Dyslipidaemia. (The JEWEL Study)
Brief Summary: To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.


Options:
A: Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 (Baseline and Week 7)
B: To evaluate the number of patients who reach target blood pressure (BP) and; LDL-C targets as defined by their governing guidelines.
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan
Brief Summary: In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.


Options:
A: Mean number of days to gametocyte clearance (gametocyte clearance time, GCT) (14 days); Mean (+/- SD) maximal fall in Hb (g/dL) from enrollment to day 28 of follow-up (28 days)
B: Prevalence of P. falciparum gametocyte carriers (QT-NASBA) (Day 7)
C: Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum (6 months)
D: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (14 days from start of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan
Brief Summary: In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.


Options:
A: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)
B: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (14 days from start of treatment)
C: Mean number of days to gametocyte clearance (gametocyte clearance time, GCT) (14 days); Mean (+/- SD) maximal fall in Hb (g/dL) from enrollment to day 28 of follow-up (28 days)
D: Cure rate (63 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan
Brief Summary: In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.


Options:
A: Parasitological cure rate, PCR corrected, at day 28 in the PP population The ITT population is a key supportive analysis.
B: Parasitological outcome after 28 days follow-up (28 days)
C: Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
D: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (14 days from start of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Chemotherapy in Elderly Patients With Breast Cancer: Weekly Docetaxel vs. CMF
Brief Summary: The purpose of this study is to compare disease free survival of elderly breast cancer patients treated with standard adjuvant chemotherapy (CMF) versus experimental adjuvant chemotherapy (weekly docetaxel).


Options:
A: Disease-free Survival (up to 5.25 years (63 months))
B: disease free survival (at 5 years)
C: Disease-Free Survival (after 10 years follow up)
D: Relapse Free Survival (RFS) 4 vs. 6 Cycles (from baseline up to 4 years); Duration of Disease Free Survival (RFS) (from baseline up to 6.4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Phase II, Dose-Escalation Clinical Study to Assess the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Fixed Dose Combination of Pyronaridine and Artesunate (3:1) in Children With Acute Falciparum Malaria
Brief Summary: The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.


Options:
A: PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 (Day 28)
B: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
C: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
D: Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Phase II, Dose-Escalation Clinical Study to Assess the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Fixed Dose Combination of Pyronaridine and Artesunate (3:1) in Children With Acute Falciparum Malaria
Brief Summary: The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.


Options:
A: result of PCR (42 day)
B: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
C: PCR-Corrected ACPR at Day 28 (Day 28)
D: Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Phase II, Dose-Escalation Clinical Study to Assess the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Fixed Dose Combination of Pyronaridine and Artesunate (3:1) in Children With Acute Falciparum Malaria
Brief Summary: The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.


Options:
A: Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
B: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
C: PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 (Day 28)
D: Crude Cure Rate on Day 14 (Day 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Training and Depression in Older Adults II
Brief Summary: This study will evaluate the effectiveness of both center-based and home-based exercise versus the antidepressant drug sertraline in treating depression in middle-aged and older adults.


Options:
A: Measured at Week 16 and Months 6 and 12 post-treatment: Post-treatment recovery from MDD; Post-treatment depression scores on the Hamilton Depression Rating Scale
B: HAMD-17
C: The aim of the study is to investigate whether regular exercise after adjuvant treatments of breast cancer could prevent osteoporosis and improve quality of life. (1-10 years)
D: VO2max and resting systolic blood pressure (at 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer
Brief Summary: RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.


Options:
A: Disease specific mortality (Median 15 years follow up)
B: Freedom from failure
C: Interval before biochemical failure (10 years)
D: Five-year Disease-free Survival (DFS) Rate (Analysis occurs after all patients have been followed for five years.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.
Brief Summary: This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.


Options:
A: HbA1c (after 26 weeks of treatment)
B: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 (Baseline and Week 52)
C: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)
D: Change in Glycosylated Haemoglobin A1c (HbA1c) (week 0, week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.
Brief Summary: This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.


Options:
A: HbA1c (after 26 weeks of treatment)
B: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: HbA1c (after 26 weeks of treatment)
D: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.
Brief Summary: This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.


Options:
A: To assess the pharmacokinetics of exenatide (Three day-long (8 hour) assessments over a 5-week period); To assess the pharmacodynamics of exenatide (Three day-long (8 hour) assessments over a 5-week period); Number of adverse events (Visit 2 through Visit 4)
B: Change in HbA1c From Baseline to Week 30 (Day -3, Week 30); Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose) (Week 22)
C: HbA1c (after 26 weeks of treatment)
D: HbA1c (after 26 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Proactive Communication Strategy for Family Members of Patients Dying in the ICU: A Multicenter Randomized Controlled Trial
Brief Summary: Decisions to limit life sustaining treatments are made for most patients dying in the ICU, usually with input from the family. The well-being of the family may be jeopardized by involvement in the decision-making process and bereavement. We evaluated the ability of a proactive communication strategy (family conference and providing family members with a bereavement information leaflet) designed to improve family well-being.


Options:
A: Hospital Anxiety and Depression Scale (Day 90)
B: length of stay and depression (ICU admission, Day 5, discharge, and 2 months)
C: Patient self-reported anxiety (First three days on ICU and/or within 24 hours after ICU discharge)
D: symptoms related to posttraumatic stress disorder

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Proactive Communication Strategy for Family Members of Patients Dying in the ICU: A Multicenter Randomized Controlled Trial
Brief Summary: Decisions to limit life sustaining treatments are made for most patients dying in the ICU, usually with input from the family. The well-being of the family may be jeopardized by involvement in the decision-making process and bereavement. We evaluated the ability of a proactive communication strategy (family conference and providing family members with a bereavement information leaflet) designed to improve family well-being.


Options:
A: Aim 1: feasibility and acceptability of learning Motivational Interviewing techniques by palliative care clinicians (Through study completion, an average of 1 year.)
B: Hospital Anxiety and Depression Scale (At 6 months)
C: Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool (6 month)
D: symptoms related to posttraumatic stress disorder

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Hip Replacement.
Brief Summary: The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.


Options:
A: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (Treatment period: up to day 35+/-6)
B: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (Treatment period : up to day 36+/-6)
C: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (28-35 days)
D: Thromboembolism occuring between day 7-35 ;; Major bleeding occuring between day 7-35 ;; LMWH induced thrombopenia; All cause mortality

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Brief Summary: This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).


Options:
A: Clinical Global Impression - Severity (Week 12); Clinical Global Impression - Improvement (Week 12)
B: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)
C: Change From Baseline at Week 24 on the Vineland Adaptive Behavior Scales (Vineland-II) Two-domain Composite (2DC) Score. (Week 24)
D: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score (baseline, 8 weeks after dosing)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Brief Summary: This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).


Options:
A: NCBRF-TIQ D-Total Score (Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9)
B: Scores in the Young Mania Rating Scale (BD); Scores in the SNAP-IV (ADHD); Weight
C: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)
D: Aggressive behavior (Measured weekly for 11 to 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Brief Summary: This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).


Options:
A: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (Baseline and Week 4)
B: Percentage of Patients Relapsing by Week 16 (From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment)
C: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)
D: Change in Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline and Day 42)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Safety and Efficacy of Two Different Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment in Patients With HIV-1 and Tuberculosis
Brief Summary: Protocol Summary

Title: Evaluation of safety and efficacy of two different once daily anti-retroviral treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and tuberculosis - Randomized Controlled Clinical Trial

Phase: Phase III trial

Population: 180 HIV-1 positive patients with tuberculosis

Number of Sites: Four.

1. Tuberculosis Research Centre, Chennai
2. Government Medical College, Vellore
3. Government Hospital of Thoracic Medicine, Tambaram
4. Government Rajaji Hospital, Madurai

Study Duration: 26 months including 24 months of ART.

Study Objectives:

Primary Objective To compare the efficacy and safety of two different once-daily anti-retroviral treatment regimens (along with standard anti-tuberculosis treatment) in patients with HIV-1 and tuberculosis, by using virologic end points.

Secondary Objective To compare the efficacy of antiretroviral treatment given under partial supervision with unsupervised treatment (once a month supply).


Options:
A: To compare proportion of patients who achieved undetectable plasma HIV-1RNA< 50 copies/mL at 48 weeks after initiation of antiretroviral treatment between the 2 groups (48 weeks)
B: Suppression of Viral load to < 400 copies/ml or a two log reduction in viral load from the baseline value at the end of 6 months and a viral load <400 copies/ml at 24 months of antiretroviral therapy (Dec 2008)
C: Viral load measure (Virological failure will be defined after 2 consecutive measures as : More than 1 log10 increase in plasma HIV-1 RNA concentration for patients with detectable viral load (> 50 copies/mL) at the previous dosage.) (3, 6 and 12 months)
D: Virological suppression at 48 weeks. (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacotherapies: Efficacy, Mechanisms and Algorithms
Brief Summary: The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.


Options:
A: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)
B: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
C: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
D: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacotherapies: Efficacy, Mechanisms and Algorithms
Brief Summary: The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.


Options:
A: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
B: Biochemically verified 7 day point prevalence abstinence from smoking.
C: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
D: Expired-air Carbon Monoxide Confirmed Smoking Abstinence (52 weeks)

Answer: C