TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
Brief Summary: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses


Options:
A: The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. (13 weeks)
B: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 (12 Weeks)
C: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
D: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
Brief Summary: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses


Options:
A: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 (Week 16); Number of Participants Experiencing Adverse Events (Up to 72 weeks); Number of Particpants Discontinuing Study Treatment Due to Adverse Events (Up to 52 weeks)
B: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (Week 12); Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) (Week 12)
C: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
D: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 (12 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
Brief Summary: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses


Options:
A: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)
B: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 (12 Weeks)
C: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)
D: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3
Brief Summary: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.


Options:
A: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Baseline and 12 weeks)
B: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (Weeks 4, 8 12, and 16 (Period B)); Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) (Weeks 4, 8, 12, and 16 (Period B)); Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C)); Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C))
C: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (0-12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (0 - 12 Weeks)
D: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3
Brief Summary: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
B: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)
C: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 (from week 0 to week 12)
D: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3
Brief Summary: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)
B: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
C: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline (Baseline to Week 16)
D: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3
Brief Summary: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.


Options:
A: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16 (Week 16)
B: Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase (Baseline and Week 16 of the placebo-controlled phase)
C: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)
D: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial
Brief Summary: The purpose of this study is to evaluate the effect of intraoperative administration of low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.


Options:
A: Proportion of patients who received a blood transfusion during their hospital stay following surgery (From the day of surgery until hospital discharge (or until day 30 if patient is still hospitalized).)
B: Postoperative Bloodloss (Day 1 after surgery)
C: Intraoperative blood loss (End of surgery (last suture))
D: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Comparison of Sublingual Buprenorphine to Morphine Sulfate in the Treatment of Neonatal Abstinence Syndrome (NAS)
Brief Summary: The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence Syndrome (NAS).


Options:
A: Heart Rate (up to 2 weeks); Respiratory Rate (up to 2 weeks); O2 sats (up to 2 weeks); Activity level (up to 2 weeks); Sleep category (up to 2 weeks); Feeding (sucking and absorption) category (up to 2 weeks); Neonatal Abstinence Scoring (NAS) (up to 2 weeks)
B: Length of Hospitalization (Up to 4 months)
C: Hospital length of stay (Up to hospital discharge, an anticipated average of 4 weeks)
D: Change in Infant Movement between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Breathing between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Heart Rate between Mattress ON and Mattress OFF(control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults
Brief Summary: The purpose of this trial is to determine whether the new inactivated polio vaccine that is based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy adults.


Options:
A: Number of Subjects Reporting Solicited Local Symptoms (During the 4-day follow-up period after each dose of study vaccine.); Number of Subjects Reporting Solicited General Symptoms (During the 4-day follow-up period after each dose of study vaccine.); Number of Subjects Reporting Unsolicited Adverse Events (AEs) (During the 31-days follow-up period after each dose of the study vaccine.); Number of Subjects Reporting Serious Adverse Events (SAEs) (During the entire study period (from Dose 1 up to one month following last vaccine dose).)
B: Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination. (30 days post-vaccination); Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine (30 days post-vaccination and entire study duration)
C: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 (At Month 3, one month after the third vaccine dose)
D: Number of adverse reactions following vaccination (4 days or until adverse reactions have resolved)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Acceptability and Feasibility of a Diet and Physical Activity Intervention to Prevent Recurrence in Colorectal Cancer Survivors: a Phase 2 Study
Brief Summary: Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong Kong. A recent report concluded physical activity (PA) protects against colon cancer and foods low in dietary fibre, red meat and processed meat cause CRC. Yet, the influence of lifestyle factors on cancer outcome (i.e. recurrence and survival rates) in CRC survivors is largely unknown.

Objectives \& hypothesis - Our study aims to evaluate the acceptability of two behavioural interventions for CRC survivors intended to improve cancer outcome and designed to (1) increase PA levels and (2) reduce consumption of a Western diet.

The investigators hypothesize that the proposed interventions are (1) efficacious in changing the two targeted behaviours; and (2) acceptable to CRC survivors.

Settings and methods - Phase 2 feasibility trial. Two hundred and twenty-four CRC survivors within 12 months of completion of cancer treatment and without evidence of persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted behaviours prescribed over 12 months. Primary outcome measure is whether the target levels of PA and dietary intake could be met at the end of intervention. Secondary outcome measures include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and determinants of compliance; (3) facilitators and barriers to behavioural change; (4) measurement of theoretical constructs underlying PA and dietary interventions; (5) possible health benefits and side effects (PA-associated injury and nutritional deficiency) arising from the interventions. Outcome will be assessed at baseline, 6 months into intervention and then at 0, 6 and 12 months post-intervention.

Impact - If proven feasible, our intervention programme would pave way for a large randomized controlled trial testing the effect of PA and diet on the treatment outcome of CRC.


Options:
A: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)
B: Whether the PA and dietary intake targets are met at the end of intervention; (at the end of 12 months of intervention)
C: Health-related quality of life (Week 10)
D: Patient perception and pattern of change (3 months of training followed by 6 and 12 months of no formal training)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Acceptability and Feasibility of a Diet and Physical Activity Intervention to Prevent Recurrence in Colorectal Cancer Survivors: a Phase 2 Study
Brief Summary: Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong Kong. A recent report concluded physical activity (PA) protects against colon cancer and foods low in dietary fibre, red meat and processed meat cause CRC. Yet, the influence of lifestyle factors on cancer outcome (i.e. recurrence and survival rates) in CRC survivors is largely unknown.

Objectives \& hypothesis - Our study aims to evaluate the acceptability of two behavioural interventions for CRC survivors intended to improve cancer outcome and designed to (1) increase PA levels and (2) reduce consumption of a Western diet.

The investigators hypothesize that the proposed interventions are (1) efficacious in changing the two targeted behaviours; and (2) acceptable to CRC survivors.

Settings and methods - Phase 2 feasibility trial. Two hundred and twenty-four CRC survivors within 12 months of completion of cancer treatment and without evidence of persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted behaviours prescribed over 12 months. Primary outcome measure is whether the target levels of PA and dietary intake could be met at the end of intervention. Secondary outcome measures include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and determinants of compliance; (3) facilitators and barriers to behavioural change; (4) measurement of theoretical constructs underlying PA and dietary interventions; (5) possible health benefits and side effects (PA-associated injury and nutritional deficiency) arising from the interventions. Outcome will be assessed at baseline, 6 months into intervention and then at 0, 6 and 12 months post-intervention.

Impact - If proven feasible, our intervention programme would pave way for a large randomized controlled trial testing the effect of PA and diet on the treatment outcome of CRC.


Options:
A: Whether the PA and dietary intake targets are met at the end of intervention; (at the end of 12 months of intervention)
B: Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care (During 9 weeks of first line chemotherapy)
C: Change from Baseline in Body Composition (At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)
D: Breast Cancer Recurrence (Lifetime)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Compliance/Adherence After Kidney Transplant, With or With Out an Electronic Drug Dispenser(Med-O-Wheel™), Karolinska University Hospital.
Brief Summary: Background:

Adherence to the immunosuppressive drug regimen is critical to the outcome after an organ transplant. Patients need to take their prescribed medications and attend their appointments with the doctor.

Based on previous studies in other European countries, the cost of non-compliance after organ transplantation in Sweden is \>SEK 35 million/year.

Patients who lose their graft both lose quality of life and have decreased expected survival; moreover, retransplantation may be hampered by new HLA antibodies.

Question:

The primary question is whether Med-O-Wheel™ can improve compliance to the prescribed medication regimen in renal transplant patients.

Methods and materials:

All kidney transplant patients at Karolinska University Hospital, Huddinge, will be given information about the study and will then be asked to participate. Participants will be randomized into two arms, one arm with and one with out Med-O-Wheel™. The 80 included patients will be closely monitored for 1 year regarding intake of prescribed medications.

Med-O-Wheel™ is an electronic medication dispenser that records the date and time of each occasion when the patient takes medications from the dispenser. It has a SIM card and text messaging capabilities.

Addoz Portal™ is a web-based application that makes it possible to monitor and analyse medication intake. Each event in the medication dispenser is registered in the portal, which communicates with the care provider/support person by text message, e-mail or telephone.

Significance of the study:

In the future it may be possible to improve compliance in transplant patients. In particular, patients will feel secure since they will receive confirmation through the portal that they are taking their medications safely and accurately.


Options:
A: Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients? (2013)
B: Adherence as measured by unannounced telephone pill count (3 months)
C: change from baseline BMI at 8 months (8th month)
D: Self-care agency and self-care behaviors (performing of self-monitoring, adhering to the medical regimen, communicating with the transplant team) (1 year post-discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
Brief Summary: The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.


Options:
A: Proportion of Participants With New Vertebral Fractures (Baseline through 24 Months)
B: Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months (Baseline and 12 months); Mean percent change from baseline in hip trochanter BMD at 24 months (Baseline and 24 months)
C: Mean percent change from baseline in hip trochanter bone mineral density (BMD)
D: Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group. (Baseline, 6, and 12 months)

Answer: A