TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions for Chronic Diseases: Effect of Patient Values and Effectiveness Information on Patients' Choice of Therapy, Adherence to Therapy and Satisfaction With Therapy
Brief Summary: Few studies have explored how specific formats of effectiveness information effect on real patients' decisions. We only know little about what kind of format would be the optimal to help patients make well-informed real-life decisions corresponding to their preferences.

The trial is developed in a clinical randomised design to study risk communication in the shared decision making between general practitioners (GP) and their patients in primary prevention with of cholesterol lowering drug. Endpoints are effect of GPs' information about treatment effectiveness and their patients' values on patients' tendency to accept and adhere to the treatment as well as their feeling of content with the choice made. GPs are randomised to inform about risk and treatment effectiveness by means of either absolute risk reduction (ARR) or Prolongation of Life (POL). Afterwards patients are invited to answer questionnaires concerning their content with decisions and reflections. Patients' redemption of prescriptions during the following week and the first year are recorded through an electronic database.

57 GPs and 248 patients have been enrolled in the trial.


Options:
A: Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing (2 weeks after enrollment)
B: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)
C: Changes in decisional conflict (baseline and 3 month post intervention)
D: Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months (6 months); Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months (3 months); Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months (3 months); Quality of life as assessed by SF-12 health survey at 3 and 6 months (6 months); Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions for Chronic Diseases: Effect of Patient Values and Effectiveness Information on Patients' Choice of Therapy, Adherence to Therapy and Satisfaction With Therapy
Brief Summary: Few studies have explored how specific formats of effectiveness information effect on real patients' decisions. We only know little about what kind of format would be the optimal to help patients make well-informed real-life decisions corresponding to their preferences.

The trial is developed in a clinical randomised design to study risk communication in the shared decision making between general practitioners (GP) and their patients in primary prevention with of cholesterol lowering drug. Endpoints are effect of GPs' information about treatment effectiveness and their patients' values on patients' tendency to accept and adhere to the treatment as well as their feeling of content with the choice made. GPs are randomised to inform about risk and treatment effectiveness by means of either absolute risk reduction (ARR) or Prolongation of Life (POL). Afterwards patients are invited to answer questionnaires concerning their content with decisions and reflections. Patients' redemption of prescriptions during the following week and the first year are recorded through an electronic database.

57 GPs and 248 patients have been enrolled in the trial.


Options:
A: Incidence choice for eSET (after embryo transfer)
B: Informed choice (2 weeks post intervention); Involvement in screening decision (2 weeks post intervention)
C: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)
D: Change in severity of depression symptoms: Centre for Epidemiologic Studies Depression Scale (CES-D) (Baseline, 3 months, 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: IRB-HSR# 14583: Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients
Brief Summary: The investigators hypothesize that given prophylactically, intravenous ondansetron will attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia.

Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo elective caesarean section will be enrolled.

Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy will randomize and dispense study drug.

Baseline measurements of vital signs will be taken. Otherwise standard management will then be used:

* Patients must be NPO for 8 hours
* Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3 minutes, more frequently if decided by the provider.
* Standard lumbar puncture in a sitting position the L3-L4 or L4-L5
* Whitacre pencil-point, 25 gauge
* Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20 mcg fentanyl
* Immediately after completing the subarachnoid injection, patients will be laid supine with left lateral uterine displacement

The sensory level of anesthesia will be assessed in the standard fashion every five minutes using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0, no paralysis; 1, inability to lift the thigh \[only knee/feet\]; 2, inability to flex the knee \[only feet\]; 3, inability to move any joint in the legs).


Options:
A: Early Profound Fetal Bradycardia (Within 30 minutes of combined spinal epidural (CSE) placement)
B: The time required to remain sitting after spinal anesthesia (start with 3 minutes after completion of spinal then we ll go up or down)
C: Incidence of hypotension (Time between induction of spinal anesthesia until delivery)
D: Number of Participants with Adverse Events as a Measure of Safety and Tolerability" (day 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: IRB-HSR# 14583: Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients
Brief Summary: The investigators hypothesize that given prophylactically, intravenous ondansetron will attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia.

Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo elective caesarean section will be enrolled.

Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy will randomize and dispense study drug.

Baseline measurements of vital signs will be taken. Otherwise standard management will then be used:

* Patients must be NPO for 8 hours
* Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3 minutes, more frequently if decided by the provider.
* Standard lumbar puncture in a sitting position the L3-L4 or L4-L5
* Whitacre pencil-point, 25 gauge
* Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20 mcg fentanyl
* Immediately after completing the subarachnoid injection, patients will be laid supine with left lateral uterine displacement

The sensory level of anesthesia will be assessed in the standard fashion every five minutes using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0, no paralysis; 1, inability to lift the thigh \[only knee/feet\]; 2, inability to flex the knee \[only feet\]; 3, inability to move any joint in the legs).


Options:
A: Number of Participants with Adverse Events as a Measure of Safety and Tolerability" (day 1)
B: Frontal lobe cerebral oxygenation (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour); Foetal heartrate (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour)
C: The time required to remain sitting after spinal anesthesia (start with 3 minutes after completion of spinal then we ll go up or down)
D: Incidence of hypotension (Time between induction of spinal anesthesia until delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage
Brief Summary: The purpose of our study is to determine how well Triple-H works and how safe it is. The investigators are hoping to determine the effects of starting the therapy early and to explore if hypervolemia and/or hypertension are beneficial, and what the optimal target ranges are.


Options:
A: Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations. (6 months)
B: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) (90 days)
C: Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization (90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization)
D: The main outcome measurement will be the modified Rankin scale at 3 months after the SAH, compared between patients who were randomized to induced hypertension and patients who were randomized to no induced hypertension. (assessed three months after the SAH)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
Brief Summary: The purpose of this study is to evaluate the efficacy of an active rehabilitation program on disability and quality of life of patients affected by dermatomyositis and polymyositis.


Options:
A: HAQ score (6 month and 1 year after rehabilitation)
B: Canadian Occupational Performance Measure (COPM) (3 months)
C: Aerobic Capacity (Twelve weeks); Muscle strength (Twelve weeks); Quality of life (Twelve weeks)
D: Hypoxia related metabolites. (At baseline before intervention.); Hypoxia related metabolites. (After 12 weeks of endurance exercise intervention/ non intervention.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multiple Risk Behavior Intervention in Health Care Settings
Brief Summary: This study (aka Healthy Directions2 or HD2) builds on an earlier study titled Healthy Directions (aka Healthy Directions 1 or HD1). HD1 was an intervention designed to target cancer prevention among multi-ethnic populations; it led to significant improvements in the multiple risk behavior score (consumption of red meat, fruits and vegetables, and multi-vitamins). Building on the success of HD1, HD2 further expanded the intervention to include smoking and physical activity. In addition, it expanded the study goals to include increasing efficacy across all target risk behaviors, and promoting long-term maintenance of behavior change.


Options:
A: Mammography Adherence (12 months)
B: Change in multiple risk behavior (MRB) score (6- and 18- months post intervention follow-ups)
C: Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status). (Baseline, 4 months and 12 months)
D: Change in Weight (Baseline to 30 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Regular Consumption of a Multiple Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren and on Their Mental and Physical Performance
Brief Summary: The purpose of this study is to assess the impact of regular consumption of micronutrient fortified drink in improving nutritional and micronutrient status in Indian school children. The test beverage will be fortified with both, vitamins and minerals.


Options:
A: Linear growth velocity (6 to 18 months of age)
B: Change from baseline in the micronutrient status in the study subjects at 6 months (6 months)
C: Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months (Baseline, after 4 months); Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months (Baseline, after 4 months); Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months (Baseline, after 4 months); Change From Baseline in Visual Reaction Time After 4 Months (Baseline, after 4 months)
D: Diarrhea; Pneumonia; Febrile illness; Growth; Development; Activity

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension
Brief Summary: This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2).

Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS).

The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores.

Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS.

The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.


Options:
A: Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (Up to 96 weeks (2 years)); Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (218 weeks)
B: Probability of Participants With Sustained Accumulation of Disability (SAD) (Up to 3 years); Annualized Relapse Rate (Up to 3 years)
C: Small effect of an intervention (immediate after completion of study); Moderate effect of an intervention (immediate after completion of study); Large effect of an intervention (immediate after completion of study)
D: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension
Brief Summary: This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2).

Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS).

The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores.

Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS.

The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.


Options:
A: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period (Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm)
B: Delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score) (every 4 weeks for one year, then every 8 weeks for one year)
C: Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (Up to 96 weeks (2 years)); Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (218 weeks)
D: Time to Confirmed Disease Progression (CDP) (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)); Percentage of Participants With CDP (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension
Brief Summary: This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2).

Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS).

The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores.

Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS.

The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.


Options:
A: Hazard ratio for relapses (During the first and during the second 52 weeks)
B: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
C: Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (Up to 96 weeks (2 years)); Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (218 weeks)
D: Time to First Relapse (Baseline up to 96 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Heart Failure Center Program on The Progression of Biomarkers, Changes in Life Quality, Left Ventricular Ejection Fraction, and Cardiac Outcomes in Patients With Congestive Heart Failure
Brief Summary: Congestive heart failure (CHF) is a major public health problem worldwide. CHF carries a devastating prognosis, which resembles that of some types of malignant cancer. Despite substantial improvements in the management of the disease, the prognosis remains poor especially in advanced stages of the disease. For these patients, self-management plan includes monitoring of symptoms such as fatigue and shortness of breath, daily weighing, and knowing what to do if signs of deterioration appear, and when to report the changes to health. The investigators hypothesize that patients in the heart failure management programs that promote self-management by means of intensive education, edema index-assistance, and telephone follow-up can improve their functional status and quality of life, as well as the biomarkers of CHF, left ventricular systolic function, proteinuria and nutritional status.


Options:
A: Goal Attainment Scaling at 3 months (3 months)
B: All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations (2 year)
C: Rate of readmission (30 days)
D: Total Number of Medications (Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC)

Answer: B