TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.
Brief Summary: This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Options:
A: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
B: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
C: Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response (Baseline to the end of the retreatment period (up to 7 years, 6 months))
D: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.
Brief Summary: This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Options:
A: Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 (Day 169); Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population (Days 85, and 169 and postvisits on Days 28, 56, and 85)
B: Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28) (Month 6 (randomization) and Month 12)
C: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
D: Percentage of patients with ACR 20 response (Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: BRAF and Nevi.Nevi Are Common Benign Pigmented Tumors of the Skin. Mutations in So-called BRAF and NRAS Genes Genes Appear to be Initiating Events Responsible for the Formation of Nevi.
Brief Summary: This project is a multicenter study in which we will investigate a dual concept of nevogenesis. Study location is the Department of Dermatology at the Medical University of Graz in collaboration with centers in Austria (Vienna), Italy (Naples, Benevento, Modena), Spain (Barcelona) and the United States (New York).

The hypothesis is that small congenital melanocytic nevi (CMN), "early" acquired melanocytic nevi in childhood (AMN) and dermal nevi, all dermatoscopically characterized by globular pattern, belong to the same spectrum of genetically determined melanocytic proliferations that develop due to endogenous pathways, in contrast to "true" acquired melanocytic nevi, dermatoscopically showing reticular pattern, that develop due to exogeneous factors such as UV-exposure.


Options:
A: Frequency of BRAF Mutations Among Nevi (up to 30 months)
B: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)
C: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
D: Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. (Within the first week after surgical excision of suspected BCC lesion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery
Brief Summary: The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.


Options:
A: Frequency of delivery <=32 weeks (18 weeks gestation through delivery)
B: Weeks Gestation at Birth Among Patients Receiving the Active Drug. (Through delivery, until discharge up to 40 weeks gestation)
C: Delivery prior to 35 weeks 0 days gestation (Delivery Date)
D: Spontaneous delivery before 34 completed weeks (238 days) of gestation.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery
Brief Summary: The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.


Options:
A: Delivery before than 37 weeks gestation (Up to 37 weeks gestation)
B: Gestational age at delivery (3-6 months)
C: Spontaneous delivery before 34 completed weeks (238 days) of gestation.
D: Frequency of delivery <=32 weeks (18 weeks gestation through delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery
Brief Summary: The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.


Options:
A: Spontaneous delivery before 34 completed weeks (238 days) of gestation.
B: Weeks Gestation at Birth Among Patients Receiving the Active Drug. (Through delivery, until discharge up to 40 weeks gestation)
C: Frequency of delivery <=32 weeks (18 weeks gestation through delivery)
D: Delivery prior to 35 weeks 0 days gestation (Delivery Date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery
Brief Summary: The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.


Options:
A: Spontaneous delivery before 34 completed weeks (238 days) of gestation.
B: The incidence of delivery < 34 weeks, in the study group versus the control group (Participants will be followed until 3 weeks after delivery)
C: Gestational Age at Delivery (Measured from day of last menstrual cycle to day of birth and measured in weeks.)
D: Delivery prior to 35 weeks 0 days gestation (Delivery Date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI)
Brief Summary: The EPOC-AMI study is to assess the safety and the efficacy of systemic administration of erythropoietin for inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction


Options:
A: Glasgow Outcome Scale (at 6 months after injury)
B: In-stent Neointimal volume; In-stent Late lumen loss; Semi-Quantitative evaluation of infarcted size of myocardium
C: incidence of acute kidney injury (change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5)
D: Decrease in Delayed Graft Function

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.]
Brief Summary: HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in \> 70%, approximately, of all cervical cancers. Recently, Merck's HPV vaccine Gardasil® \[quadrivalent human papillomavirus (HPV-6,11,16,18 L1 VLP) recombinant vaccine\] has been approved by the FDA for prevention of genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV vaccine and Gardasil® have different compositions and are expected to have different efficacy profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted. This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18) to Gardasil® in healthy adult females 18-45 years of age.

The Protocol Posting has been updated as the study will be extended by 3 additional years.


Options:
A: To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme (6 months)
B: Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen. (From Month 0 up to Month 12)
C: Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies (At Month 7)
D: Number of Subjects Seroprotected Against Diphtheria and Tetanus (One month after vaccination with Boostrix Polio); Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies (One month after vaccination with Boostrix Polio); Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3 (One month after vaccination with Boostrix Polio)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)
Brief Summary: The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied


Options:
A: Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period (Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose)
B: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (Treatment period : up to day 36+/-6)
C: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (28-35 days)
D: Thromboembolism occuring between day 7-35 ;; Major bleeding occuring between day 7-35 ;; LMWH induced thrombopenia; All cause mortality

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib 45mg Versus Placebo Following 12 Weeks of Treatment in Patients With Metastatic or Recurrent Renal Cell Carcinoma Who Have Had no Previous Anti-VEGF Therapy.
Brief Summary: Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.


Options:
A: Progression Free Survival (PFS) (Up to 5 years); Overall Survival (OS) (Up to 5 years)
B: Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants (From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)); Overall Survival (OS) in PD-L1 Positive Participants (From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months))
C: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)
D: Overall Survival (OS) (Baseline up to Month 80)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib 45mg Versus Placebo Following 12 Weeks of Treatment in Patients With Metastatic or Recurrent Renal Cell Carcinoma Who Have Had no Previous Anti-VEGF Therapy.
Brief Summary: Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.


Options:
A: To evaluate if progression-free survival from randomization to progression or death during second-line therapy (Total PFS) of sorafenib followed by pazopanib is non-inferior compared to pazopanib followed by sorafenib. (4 years)
B: Progression-free Survival (PFS) (PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.)
C: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)
D: Progression-Free Survival (PFS) (From initiation of treatment up to follow-up period (up to 3 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
Brief Summary: This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Options:
A: Change in HbA1c From Baseline to Week 26 (Baseline, Week 26)
B: Absolute change from baseline in HbAlc (Week 8)
C: To assess the pharmacokinetics of exenatide (Three day-long (8 hour) assessments over a 5-week period); To assess the pharmacodynamics of exenatide (Three day-long (8 hour) assessments over a 5-week period); Number of adverse events (Visit 2 through Visit 4)
D: Mean Change From Baseline in Body Weight at Week 20 (Week 0, week 20)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)
Brief Summary: The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.


Options:
A: Clinical Cure Rate at Test of Cure (TOC) (MITT Population) (8-15 days after last dose of study drug administration); The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations. (8-15 days after last dose of study drug)
B: Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population (7 to 14 days after the last dose of study drug); Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population (7 to 14 days after the last dose of study drug)
C: Clinical Cure Rate at Test of Cure (TOC) (MITT Population) (8-15 days after the end of treatment); Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population (8-15 days after last dose of study drug)
D: Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1
Brief Summary: This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly \[QW\]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.


Options:
A: Number of Participants With Sustained Virologic Response (SVR) (From follow-up week (FW) 24 up to end of follow-up (EOF))
B: Percentage of Participants With Virologic Response at Week 12 (End of treatment (EOT) (up to Week 48))
C: Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication (Up to Week 72)
D: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1
Brief Summary: This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly \[QW\]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.


Options:
A: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
B: Sustained virological response (SVR) (24 weeks post treatment end (ie weeks 48 or 72))
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) (Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)); Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods (Up to Week 14); Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period (Up to Week 12)
D: Number of Participants With Sustained Virologic Response (SVR) (From follow-up week (FW) 24 up to end of follow-up (EOF))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial
Brief Summary: The goal of this clinical research study is to learn whether being hydrated (given liquids) through a catheter in a vein or in the tissue under the skin can improve symptoms of dehydration.

Objectives:

1.1 Determine whether parenteral hydration is superior to placebo in improving symptoms associated with dehydration (such as fatigue, myoclonus, sedation, and hallucinations) in advanced cancer patients receiving hospice care.

1.2 Determine whether parenteral hydration is superior to placebo in delaying the onset or reducing the severity of delirium in patients with advanced cancer receiving hospice care.

1.3 Describe the meaning patients and primary caregivers attribute to dehydration and re-hydration at the end of patient's lives.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: Instrumental and Physical Functionality (Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)); Re-Admission to Hospital (Assessed 3 months and 12 months after the time of hospital discharge (T1, T2).); Institutionalisation (Assessed 12 months after the time of hospital discharge (T2).)
C: Participant Reduced Symptom Burden (From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion))
D: Functional status:Barthel Index. (through study completion, an average of 3 months); Mini-Nutritional Assessment scores (MNA) (through study completion, an average of 3 months); Mini Mental State Examination scores (MMSE) (through study completion, an average of 3 months); Frailty rates and transition between frailty states (through study completion, an average of 3 months); Postoperative delirium incidence rate [Confusion Assessment Method (CAM)] (through study completion, an average of 3 months); Postoperative bowel dysmotility (through study completion, an average of 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial
Brief Summary: The goal of this clinical research study is to learn whether being hydrated (given liquids) through a catheter in a vein or in the tissue under the skin can improve symptoms of dehydration.

Objectives:

1.1 Determine whether parenteral hydration is superior to placebo in improving symptoms associated with dehydration (such as fatigue, myoclonus, sedation, and hallucinations) in advanced cancer patients receiving hospice care.

1.2 Determine whether parenteral hydration is superior to placebo in delaying the onset or reducing the severity of delirium in patients with advanced cancer receiving hospice care.

1.3 Describe the meaning patients and primary caregivers attribute to dehydration and re-hydration at the end of patient's lives.


Options:
A: Delirium (5 days); Subsyndromal delirium (5 days)
B: Recruitment rate (Up to 12 months)
C: Participant Reduced Symptom Burden (From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion))
D: postoperative delirium (2 MONTHS)

Answer: C