TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Intervention for Preterm Infants
Brief Summary: The first aim is to develop a clinic-based intervention program and a home-based intervention program for VLBW preterm infants that have common intervention services but are respectively delivered at clinic and home. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age. The clinical feasibility and usefulness of implementing these intervention programs within the context of randomized intervention study subject to the existing constraints of the hospital and home settings will be tested in a pilot study.

The second aim is to conduct a randomized control trial to examine the costs and effectiveness of the UCP, the CBIP, and the HBIP for VLBW preterm infants. Gender and socio-economically matched normal full-term infants will also be included as a comparison group. Outcome measures that include child, parenting, and transactions outcomes will be compared between groups. Child outcome measures will include health status, growth, neurodevelopment, and neurosensory status; parenting outcome measures will include maternal parenting competence, social support, and psychological stress; transactions outcome measure will be mother-infant interaction. Costs (direct and indirect costs) associated with each early intervention program during the follow-up period will be estimated. Average and incremental cost/effectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants.


Options:
A: Changes on Infant Motor Profile (IMP) (T0(baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over), T3: 18 months)
B: Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan. (In-hospital, 6, 12, 18 and 24 months of age)
C: Cognitive and behavioral outcome; Parenting Stress
D: Peabody Developmental Motor Scales(PDMS-2) (Two years post term age)

Answer: B
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 II 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: Reduction of the Estimated 10-year Total Cardiovascular Risk Score (Six months)
B: 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)
C: Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 (Baseline and Week 7)
D: To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing percentage of subjects who reach target BP and LDL-C targets as defined by their governing guidelines.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031
Brief Summary: Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone


Options:
A: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) (Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]); Change From Baseline in CGI-I at End of Study (up to 5 Years) (Baseline, up to 5 years (End of Study [LOCF])); Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) (Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]); Change From Baseline in CGI-S at End of Study (up to 5 Years) (Baseline, up to 5 years (End of Study [LOCF]))
B: Reduction of PANSS total score (Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.)
C: The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality within 12 months.
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational,Multicenter,Randomized,Double-Blind,Placebo-Controlled,Parallel-Group Study to Assess the Efficacy of Ciclesonide Metered-Dose Inhaler at a Daily Dose of 160 μg Administered Either in a Once-Daily in the Morning Regimen (160 μg qd AM) for 16 Weeks or in a 160 μg qd AM Regimen for 12 Weeks Preceded by a Twice-Daily Regimen (80 μg Bid) for 4 Weeks,or in an 80 μg Bid Regimen for 16 Weeks,in Adults and Adolescents With Mild to Moderate Persistent Asthma Not Treated With Steroids
Brief Summary: To investigate the efficacy of ciclesonide MDI either as once daily or twice daily in patients with mild to moderate asthma, who have not previously been treated with an inhaled corticosteroid.


Options:
A: Change from baseline to Week 16 in FEV1
B: Change from baseline to Week 12 in FEV1
C: Subject's height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject's stadiometer height data
D: Change From Baseline in Morning Peak Expiratory Flow (PEF) (Baseline and Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy of Ciclesonide Metered-Dose Inhaler at a Daily Dose of 160 μg Administered for Twelve Weeks Either in a Once-Daily Regimen in the Morning (160 μg qd AM) or in a Twice Daily Regimen (80 μg Bid) in Adults and Adolescents With Mild to Moderate Persistent Asthma Treated Previously With Inhaled Corticosteroids
Brief Summary: To investigate the efficacy of ciclesonide MDI either as once daily or a twice daily regimen in patients with mild to moderate asthma, who have previously been treated with an inhaled corticosteroid.


Options:
A: Change From Baseline in Morning Peak Expiratory Flow (PEF) (Baseline and Week 12)
B: time until the first severe asthma exacerbation occurs; number of poorly controlled asthma days.
C: PC20 AMP (Post-treatment Compared to Baseline) (Baseline and 5 weeks)
D: Change from baseline to Week 12 in FEV1

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized Study of Clopidogrel 75 mg/d vs Placebo, on a Background of ASA 75-100 mg/d,in Peripheral Arterial Disease (PAD) Patients Receiving a Unilateral Below Knee Bypass Graft.
Brief Summary: Primary objective:

To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of PAD.

Secondary objectives:

Comparison, between the two treatment groups, of :

* Primary patency,
* Assisted primary patency,
* Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.
* Ankle Brachial Pressure Index (ABPI) changes from baseline


Options:
A: The composite of cardiac death or MI in the intent-to-treat population (1 year after randomization)
B: Death and the composite outcome of death, non-fatal reinfarction or stroke
C: Primary Outcome The composite of cardio-vascular death, MI, stent thrombosis, TVR and bleeding (minor or major) following randomly assigned DES implantation (12 months after stent implantation)
D: 1st occurrence over the duration of follow-up of : index bypass graft occlusion based on imaging procedure, or graft replacement or endovascular intervention, or amputation above the ankle of the affected limb or death

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-controlled,Double-blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter (AF/AFL)
Brief Summary: To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).

To assess that dronedarone is well tolerated in this population.


Options:
A: recurrence of atrial fibrillation (6 month)
B: Time to first documented recurrence of symptomatic sustained AF. (Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing); Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events (Safety assessments within Day 120 of dosing)
C: First Hospitalization for Cardiovascular Reason or Death From Any Cause (minimum follow-up duration: 1 year ; maximum: 2.5 years)
D: Death from any cause or adjudicated hospitalization for worsening heart failure (Until study cut-off date)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin
Brief Summary: To compare the progression of diabetic retinopathy in type 2 diabetic patients with mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.


Options:
A: The percentage of patients with a 3-step or greater progression in the patient; level recoded integer ETDRS retinopathy scale
B: Change in HbA1c (percentage %) (Baseline to 6 Months)
C: HbA1c (after 26 weeks of treatment)
D: Hemoglobin A1c Change From Baseline (Baseline to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin
Brief Summary: To compare the progression of diabetic retinopathy in type 2 diabetic patients with mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.


Options:
A: Hemoglobin A1c Change From Baseline (Baseline to 6 months)
B: Difference in A1c Levels (baseline and 24 weeks); Number of Hypoglycemic Events (between 1rst and 24 weeks of each treatment arm)
C: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
D: The percentage of patients with a 3-step or greater progression in the patient; level recoded integer ETDRS retinopathy scale

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.
Brief Summary: The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.


Options:
A: Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12) (Day 1 (Baseline) to Day 84 (Week 12))
B: Daily pain scores and recurrence attack rate. (30 days after initiation of treatment)
C: Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. (Last Visit on treatment (up to 6 months))
D: Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). (Last 3 visits (any last 3 visits up to week 28))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: PROspective PioglitAzone Clinical Trial In MacroVascular Events: A Macrovascular Outcome Study in Type 2 Diabetic Patients Comparing Pioglitazone With Placebo in Addition to Existing Therapy
Brief Summary: The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.


Options:
A: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (week 0, week 52); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 (week 0, week 104); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 (week 0, week 156)
B: Number of Participants With Limb Salvage (24 weeks)
C: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
D: A composite endpoint including: all-causes mortality, non fatal myocardial infarction (MI) - including silent MI- , non fatal stroke, unplanned coronary revascularization (48 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PROspective PioglitAzone Clinical Trial In MacroVascular Events: A Macrovascular Outcome Study in Type 2 Diabetic Patients Comparing Pioglitazone With Placebo in Addition to Existing Therapy
Brief Summary: The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.


Options:
A: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
B: The change of HbA1C (24weeks)
C: Glycemic control (HbA1c).
D: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population (Baseline and every study visit up to 24 weeks); Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population (Baseline and every study visit up to 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PROspective PioglitAzone Clinical Trial In MacroVascular Events: A Macrovascular Outcome Study in Type 2 Diabetic Patients Comparing Pioglitazone With Placebo in Addition to Existing Therapy
Brief Summary: The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.


Options:
A: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)
B: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
C: Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) (From Randomization at Visit 3 up to the Final Visit (average of 162 days)); Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D (From Randomization at Visit 3 to Final Visit (up to 162 days))
D: Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke (Throughout study, approximately 4.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-Label, Randomized, Allopurinol-Controlled Study to Assess the Long-Term Safety of Oral Febuxostat in Subjects With Gout
Brief Summary: The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.


Options:
A: Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). (Last 3 visits (any last 3 visits up to week 28))
B: Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. (Month 1); Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12. (Month 12); Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24. (Month 24); Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36. (Month 36); Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment. (Last Visit on treatment (up to 40 months).)
C: Daily pain scores and recurrence attack rate. (30 days after initiation of treatment)
D: Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. (Last Visit on treatment (up to 6 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Myocardial Infarction With HyperOxemic Therapy II
Brief Summary: To determine whether or not HyperOxemic therapy rendered to patients (that meet the study inclusion criteria) with anterior acute myocardial infarction \< 6 hours from symptom onset to reperfusion, results in a significant reduction in infarct size as measured by SPECT @ 14 days post event.


Options:
A: Myocardial Infarct Size (At 72 hours post infarct)
B: 1-year all-cause mortality (1 year)
C: A single SPECT scan will be used to determine whether or not the treatment results in a significant reduction in infarct size in the treatment group. The scan is performed 14 days post-event. (14 +/- 7 days); Safety will be determined by comparing 30-day MACE (Major Adverse Cardiac Events) rates, where MACE is comprised by the combined incidence of death, stroke, repeat MI, and target vessel revascularization. (30 days)
D: Chest pain measured with VAS (1 h)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
Brief Summary: Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture.

We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.


Options:
A: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)
B: The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture
C: Bone mineral density (BMD) testing rates
D: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture
Brief Summary: The primary objective of this proposed research is to improve the quality of care for patients who present to the Emergency Department with osteoporosis and a fracture of the wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the primary study outcome, and it is defined as starting any one of hormone therapy, a bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist.

The study hypothesis is that a quality improvement intervention (with multiple components that include a notification system for primary care physicians, patient-specific reminders, locally generated treatment guidelines endorsed by opinion leaders, and patient education and counseling) will lead to increased use of proven efficacious osteoporosis treatments in patients eligible for secondary prevention. This hypothesis will be tested by comparing the intervention with usual care controls, in a prospective nonrandomized controlled trial.


Options:
A: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (End of project, 12/2011)
B: Cervical spine radiography ordering proportions (12 months)
C: To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge (90 days)
D: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture
Brief Summary: The primary objective of this proposed research is to improve the quality of care for patients who present to the Emergency Department with osteoporosis and a fracture of the wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the primary study outcome, and it is defined as starting any one of hormone therapy, a bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist.

The study hypothesis is that a quality improvement intervention (with multiple components that include a notification system for primary care physicians, patient-specific reminders, locally generated treatment guidelines endorsed by opinion leaders, and patient education and counseling) will lead to increased use of proven efficacious osteoporosis treatments in patients eligible for secondary prevention. This hypothesis will be tested by comparing the intervention with usual care controls, in a prospective nonrandomized controlled trial.


Options:
A: Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.
B: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)
C: The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture
D: Bone mineral density (BMD) testing rates

Answer: A