TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE)
Brief Summary: Osteopathic Manipulative Treatment (OMT) were used in the 1800s and 1900s to treat pneumonia before the introduction of antibiotics in the mid-1900s. The purpose of this study is to determine if OMT, when used in conjunction with antibiotics and other usual care, will improve the recovery of elderly pneumonia patients.


Options:
A: Glittre test (up to 9 months)
B: Change in adventitious lung sounds (24 hours after hospital presentation (baseline) and 3 weeks after intervention)
C: Muscle strength (Participants will be followed for the duration of hospital stay, an expected average of 8 days); Exercise capacity (Participants will be followed for the duration of hospital stay, an expected average of 8 days)
D: Length of Hospital Stay (End of hospital stay); Time to Clinical Stability (Daily for the duration of the hospital stay); Symptomatic and Functional Recovery Score (14, 30, and 60 days post-admission)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
Brief Summary: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.


Options:
A: Peak Concentration (Cmax) (1 day); Time to Peak Concentration (Tmax) Profile (1 day); Disposition Half-life (1 day); Area Under the Concentration-time Curve (AUC) (1 day); Apparent Oral Clearance (CL/F) (1 day); Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration (7 days); Intragastric pH (7 days); Median Intragastric pH (7 days); Percentage of Time Intragastric pH Was >4 (7 days); Mean Intraesophageal pH (7 days); Median Intraesophageal pH (7 days); Percentage of Time That Intraesophageal pH Was <4 (7 days); Normalized Area of Gastric Hydrogen Ion Activity Over Time (7 days); Normalized Area of Esophageal Hydrogen Ion Activity Over Time (7 days)
B: Maximum Observed Plasma Concentration (Cmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Time to Reach Maximum Observed Plasma Concentration (Tmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Decay Half-Life (t1/2) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Apparent Oral Clearance (CL/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Terminal-Phase Volume of Distribution (Vz/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Concentrations After Multiple Doses (Hours 2 and 4 on Day 7)
C: Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment. (Week 4); Safety Assessments (Baseline through week 8)
D: Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint) (Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
Brief Summary: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.


Options:
A: Therapeutic efficacy (24 hour)
B: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter (After 7 days of dosing.); Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter. (After 7 days of dosing.); AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter. (After 7 days of dosing.); AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter. (After 7 days of dosing.); Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter. (After 7 days of dosing.); Oral Clearance (CL/F) Pharmacokinetic Parameter. (After 7 days of dosing.); Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter. (After 7 days of dosing.); Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter. (After 7 days of dosing.)
C: Peak Concentration (Cmax) (1 day); Time to Peak Concentration (Tmax) Profile (1 day); Disposition Half-life (1 day); Area Under the Concentration-time Curve (AUC) (1 day); Apparent Oral Clearance (CL/F) (1 day); Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration (7 days); Intragastric pH (7 days); Median Intragastric pH (7 days); Percentage of Time Intragastric pH Was >4 (7 days); Mean Intraesophageal pH (7 days); Median Intraesophageal pH (7 days); Percentage of Time That Intraesophageal pH Was <4 (7 days); Normalized Area of Gastric Hydrogen Ion Activity Over Time (7 days); Normalized Area of Esophageal Hydrogen Ion Activity Over Time (7 days)
D: The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.; The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Central Venous Catheter Infections : Comparison of the Efficacy of Skin Disinfection With 5% Povidone Iodine in Alcoholic Solution Versus 0.25% Chlorhexidine, 0.025 Benzalkonium and 4% Benzylic Alcohol
Brief Summary: The best antiseptic solution for cateheter care remains unknown.High concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. No study has compare alcoholic formulations of low concentration of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central venous catheters.

To compare the incidence of central venous catheter colonization after skin disinfection with either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine, 0.025% Benzalkonium and 4% benzylic alcohol.

To compare the incidence of catheter related bacteremia in the to study groups. To compare the local and general tolerance of the two antiseptic formulations


Options:
A: Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings (48 hours); Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies (48 hours)
B: Prevention of catheter colonization
C: Skin colonisation in cfu/cm2 at the insertion site; Colonisation of the CVC-tip, positivity by definition of number cfu/5cm > 15 (Maki-method); Incidence of catheter-associated bloodstream infection (For the duration of catheter placement plus 2 days)
D: Major catheter related infection

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: American-Australian-African Trial With Dronedarone in Atrial Fibrillation or Flutter Patients for the Maintenance of Sinus Rhythm (ADONIS)
Brief Summary: To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).

To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.

To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.


Options:
A: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
B: Recurrence of Atrial Fibrillation (One year)
C: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
D: The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) (The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.); The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events (Within 7 Days of Ablation Procedure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: American-Australian-African Trial With Dronedarone in Atrial Fibrillation or Flutter Patients for the Maintenance of Sinus Rhythm (ADONIS)
Brief Summary: To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).

To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.

To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.


Options:
A: Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus (1.5 hour)
B: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
C: The primary endpoint is the time from randomization to first documented AF/AFL recurrence indicated by 12-lead ECG or trans-telephonic ECG monitoring tracings showing AF/AFL.
D: First Hospitalization for Cardiovascular Reason or Death From Any Cause (minimum follow-up duration: 1 year ; maximum: 2.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)
Brief Summary: To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).

To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.

To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.


Options:
A: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
B: The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
C: Recurrence of Atrial Fibrillation (One year)
D: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)
Brief Summary: To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).

To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.

To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.


Options:
A: The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
B: recurrence of atrial fibrillation (6 month)
C: The primary efficacy endpoint is the rate of conversion to sinus rhythm documented by ECG just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.
D: The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Radiocontrast Media Induced Nephropathy by Short-Term High-Dose Statin in Renal Insufficiency Undergoing Coronary Angiography (PROMISS)
Brief Summary: The contrast induced kidney toxicity has been known to affect the mortality and morbidity in the patients undergoing coronary angiography. But the mechanism and therapeutic strategy for it is not well known. Nowadays, it is reported that the N-acetylcysteine may have preventive effects for contrast induced kidney toxicity with its antioxidant effects.The statins have been reported to have many other effects other than the lipid lowering effect-including antioxidant effect, so we hypothesized that the antioxidant effect of simvastatin may prevent the contrast induced kidney toxicity.


Options:
A: The mean peak increase of serum creatinine concentration during day1 and day2.
B: Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control (3 days)
C: plasma troponin T level (within the first 7 days after surgery)
D: First Co-Primary Outcome (30 days post CABG surgery); Second co-primary outcome (5 years after CABG)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Managing Problem Behaviors of Alzheimer's Disease
Brief Summary: This study tests the effectiveness of an in-home intervention to reduce upset and burden among family caregivers, and decrease nursing home placement. The main hypothesis that will be tested is that compared to control group, subjects, experimental group participants will have enhanced well-being and fewer nursing home placements.


Options:
A: Frequency by severity of Agitated and Aggressive Behavior in person with dementia (3 months)
B: ADL/IADL (Baseline, t2, t3); Caregiver upset (Baseline, t2, t3); Caregiver confidence (when needed); Behaviors (Baseline, t2, t3)
C: Functional dependence (Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization)
D: Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) (Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Activity to Improve Affect in Dementia
Brief Summary: Specific Aims

1. Establish a preliminary effect size for the impact of the intervention on depressive affect and agitated behaviors in persons with dementia in 4 months
2. Evaluate acceptance of and engagement in activities in persons with dementia
3. Establish a preliminary effect size for the impact of the intervention on caregiver burden, depressive symptoms, and mastery at 4 months.
4. Evaluate caregiver skills acquisition, acceptance of and compliance to intervention techniques.


Options:
A: The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. (Baseline, 4 month (short-term follow-up), 8 month (long-term))
B: Frequency by severity of Agitated and Aggressive Behavior in person with dementia (3 months)
C: Behavioral occurrence; Care recipient depressive mood; Caregiver upset
D: Functional dependence (Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Brief Summary: The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone and 2) to determine which combination of methotrexate therapy is better


Options:
A: Percentage of Participants With American College of Rheumatology-ACR20 Response (Baseline, Week 24); Change From Baseline in Modified Total Sharp-Genant Score at Week 52 (Baseline, Week 52); Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52 (Baseline to Week 52); Change From Baseline in the Modified Total Sharp-Genant Score at Week 104 (Baseline, Week 104); Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104 (Baseline to Week 104)
B: Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR (Day 85); Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A (Length of study (through Day 85))
C: Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) (Change of the Mean of DAS28-ESR between weeks 48 - 102.)
D: Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12 (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Brief Summary: The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone and 2) to determine which combination of methotrexate therapy is better


Options:
A: Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) (Change of the Mean of DAS28-ESR between weeks 48 - 102.)
B: The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population (Day 1 to Day 365)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
D: American college of Rheumatolofy (ACR)-20 responder rate at Week 24

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Brief Summary: The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone and 2) to determine which combination of methotrexate therapy is better


Options:
A: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
B: Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) (Change of the Mean of DAS28-ESR between weeks 48 - 102.)
C: The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population (Day 1 to Day 365)
D: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High-dose Statin Therapy in the Perioperative Period and DVT Prevention.
Brief Summary: This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce inflammatory responses and deep vein thrombosis formation when given in high doses in the perioperative period.


Options:
A: Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis (Measured at baseline and 24 Months)
B: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). (Baseline and Week 6)
C: Decrease in incidence of deep vein thrombosis
D: Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization (Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.)

Answer: C