TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
Brief Summary: This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.


Options:
A: Overall Survival Time (OS) (Randomization up to 27.5 months)
B: Overall Survival (OS)- Phase 3 (Date of randomization until death (up to 2 years 3 months)); Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study) (Date of randomization until death (up to 1 year))
C: Time to Progression (every 8 weeks up to a maximum of 36 months)
D: Progression Free Survival (PFS) (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
Brief Summary: This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.


Options:
A: Overall Survival (Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years)
B: overall survival
C: Objective Response Rate ( ORR ) (60 months)
D: Overall Survival Time (OS) (Randomization up to 27.5 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
Brief Summary: Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.


Options:
A: incidence and severity of postoperative nausea and vomiting (upto 2 days after surgery)
B: the incidence of postoperative nausea and vomiting(PONV) (After spinal surgery)
C: The average depths of hypnosis as assessed by the BIS and the cAAI between skin incision and start of closure. (During anaesthesia); Postoperative nausea as assessed by a verbal rating scale (VRS) ranging between 0 and 10. (After anesthesia at 5, 10, 15, 30, 45, 60, and 90 min. At 2, 6 and 24 h after anesthesia the maximum nausea will be rated for the 30-120 min, 2-6 h, and 6-24 h interval.); Reduction of VRS nausea immediately at 2, 5, 7.5, 10, 15, 20 and 30 min after rescue treatment administration. (Maximum nausea will be rated at 2, 6 and 24 hours after treatment for the 30-120 min, 2-6 h and 6-24 h interval.)
D: pain during coughing (day 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
Brief Summary: Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.


Options:
A: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)
B: pain during coughing (day 1)
C: Nausea (0-72 hours postoperative)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
Brief Summary: Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.


Options:
A: Pain score by numeric rating scale (At 8 hours postoperatively)
B: pain during coughing (day 1)
C: Postoperative nausea and vomiting (PONV) (24-32 hours postoperative)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Interest of Pulsatile Perfusion Preservation on Outcomes in Kidney Transplantation From Expanded Criteria Donors
Brief Summary: Our hypothesis is that the Waters Medical® pulsatile perfusion machine (RM 3) is a way to improve delayed graft function (DGF) in marginal grafts, and some perfusion profiles (flow, pressure, resistance index, venous effluent pH) are correlated with better recovery of renal function (without dialysis during the first week after transplant).

Observation or Investigation Method Used :

The study is multicenter, prospective, open, controlled and randomized:grafts are divided into two parallel groups:

* group 1 corresponds to a conservation of grafts in static incubation
* group 2 corresponds to conservation using a pulsatile perfusion machine

Duration and Organizational Arrangements for Research :

The total duration of the study is planned for 36 months. This duration includes:

* an inclusion period that will last 24 months,
* the follow-up of recipient patients from the day of transplantation until twelve months after the operation


Options:
A: Delayed graft function (DGF) rate defined as the need to resort to dialysis during the first week after transplantation. The main dialysis factors retained are hydrosodic and/or hyperkalemic overload. (First week after transplantation)
B: The rate of Delayed graft function (the first week after transplant)
C: Number of patients with immediate graft function (3 months)
D: Delayed Graft Function in Kidney Allografts (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.
Brief Summary: Objective: To investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices.

Study hypothesis: The primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. The primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.


Options:
A: Medication Appropriateness Index (MAI)-Score (6 months from baseline)
B: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)
C: Success Rate of standard medical management (1 year after enrolled)
D: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.
Brief Summary: Objective: To investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices.

Study hypothesis: The primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. The primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.


Options:
A: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)
B: a designated health care proxy (12 months after intervention made available); initial bone density scan (12 months after intervention made available); administration of annual influenza vaccine (12 months after intervention started); administration of pneumococcal vaccine (12 months after the start of the intervention)
C: Medication Appropriateness Index (MAI)-Score (6 months from baseline)
D: Change in CD4 count (Throughout study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.
Brief Summary: Objective: To investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices.

Study hypothesis: The primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. The primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.


Options:
A: Adherence to blood pressure medications; Blood pressure control
B: Medication possession ratio (MPR), gaps and persistence in medicines use (Seven months after recruitment)
C: Health-related quality of life (6 months)
D: Medication Appropriateness Index (MAI)-Score (6 months from baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.
Brief Summary: Objective: To investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices.

Study hypothesis: The primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. The primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.


Options:
A: Medication Appropriateness Index (MAI)-Score (6 months from baseline)
B: Number of patients with medications discontinued, reduced dose or changed. (baseline, 3, 6 and 12 months); Number of discontinued medications, changed or changing doses. (baseline, 3, 6 and 12 months)
C: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 18 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 18 months)
D: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation and Monitoring of Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery
Brief Summary: The purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery.

Objectives:

* To describe the incidence and severity of adverse cardiovascular events in patients with coronary stents undergoing noncardiac surgery with admission.
* To assess the following-up of the guidelines about the perioperative management of antiplatelet therapy in these patients.
* To assess the relationship between the incidence of cardiac or neurovascular events, as well as bleeding complications with the perioperative management of antiplatelet therapy.
* Number of Participants with Adverse Events as a Measure of Safety


Options:
A: The change in reactive hyperemia index assessed by EndoPat (The change from 4-24 hours to between day 3 and 5 after surgery); Major adverse cardiovascular events (Within 365 days of surgery); Postoperative non-cardiovascular complications (Within 365 days of surgery)
B: quality of life (1 year); functional health (1 year); falls (1 year); cognition (1 year); emotional health (1 year); mental health (1 year); physical health (1 year); pain (1 year); intraoperative awareness (30-90 days); all-cause mortality (1 year); surgical wound infection (1 year); nerve injury (30-90 days); stroke (1 year); delirium (30-90days); Stomach Ulcer (30-90 days); Gastrointestinal Bleed (30-90 days); Pneumonia (1 year); Respiratory Failure (1 year); Respiratory Arrest (1 year); Pulmonary Embolism (1 year); Deep Vein Thrombosis (1 year); Angina (1 year); Atrial Fibrillation (1 year); Congestive Heart Failure (1 year); Cardiac Arrest (1 year); Heart Attack (1 year)
C: Deaths in one year after non-cardiac surgery in patients with and without PMI (1 year)
D: Major Adverse Cardiac and Cerebrovascular Events (MACCEs) (up to 90 days after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intermittent Hepatic Inflow Occlusion During Donor Hepatectomy In Adult Living Donor Liver Transplantation Using Right Hemiliver Grafts
Brief Summary: Intermittent hepatic inflow occlusion (IHIO), also called Pringle maneuver, is a safe and effective procedure for major hepatectomy in patients with liver disease. In addition, ischemic preconditioning with IHIO has been reported to have protective effects in patients undergoing liver resection. The role of IHIO, however, has not been fully elucidated in donors and recipients during living donor liver transplantation.


Options:
A: Postoperative Complications (30 days post procedure)
B: The Total Blood Loss (an expected average of 80 minutes)
C: N/A
D: Serum alanine aminotransferase (ALT) concentration within 5 days post-operative (pre-operative and every day till 5 days post-operative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexamethasone Intra-Erythrocyte Therapy in Patients With Chron's Disease or Ulcerative Colitis
Brief Summary: Objectives:

The primary objective of this trial was to evaluate the patients response rate at the end of the study.

Patients were considered responder if one of the following conditions occurs:

* Disease remission (Powell Tuck ≤ 3 or CDAI \< 150) and withdrawal of oral steroids therapy from at least the second treatment procedure;
* Disease marked improvement versus basal conditions (at least 5 point decrease in Powell Tuck index or 150 point decrease in CDAI score) and withdrawal of oral steroids therapy from at least the second treatment procedure.

Secondary objectives:

* to evaluate the endogenous cortisole production after receiving the study treatment
* to evaluate the inflammatory indexes (ESR and CPR) after receiving the study treatment
* to evaluate the endoscopic remission in patients suffering from mesalazine refractory Ulcerative Colitis
* to evaluate the safety of dexamethasone intra-erythrocyte therapy with particular attention to steroid-related adverse events.


Options:
A: Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo (End of Induction [Week 11, Induction Period-78 (IP-78)])
B: Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population (6 Weeks)
C: The Proportion of Patients Responders to Dex 21-P vs Placebo (From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients))
D: Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) (Week 12 (Day IP-85)); Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 (Month 12 (Day MP-365)); Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation (Day OL-1 through the end of the OL); OL; Number of Participants With AEs of Special Interest (Day OL-1 through Day OL-729); OL; Number of Participants With Physical Examination Findings (Day OL-1 through Day OL-729); OL; Number of Participants With Marked Hematology Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities (Day OL-1 through Day OL-729)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants
Brief Summary: The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.


Options:
A: Laboratory-confirmed episode of severe rotavirus gastroenteritis (From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained)
B: Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.
C: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)
D: Hospitalization for gastroenteritis (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants
Brief Summary: The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.


Options:
A: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)
B: Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody (28 days post-vaccination); Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody (28 days post-vaccination)
C: Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C) (At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)); Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group (At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)); Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to 20 U/mL in Porcine Circovirus (PCV)-Free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group (At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)); Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Lyophilised Control Group (At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)); Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group (At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries))
D: Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies (8 weeks post vaccination); Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG) (8 weeks post vaccination)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants
Brief Summary: The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.


Options:
A: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.
B: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)
C: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)
D: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs

Answer: C