TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Brief Summary: This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.


Options:
A: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
B: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (Week 24)
C: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Week 12)
D: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Brief Summary: This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.


Options:
A: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)
C: Long-term Safety and Tolerability of Secukinumab (Week 268)
D: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Introduction of Mealtime Assistance Onto an Acute Medical Ward for Older People
Brief Summary: The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward. The sustainability of providing helpers to increase dietary intake over a year will be assessed and linked to actual dietary intake. The secondary objectives are to assess the association between dietary intake resulting from mealtime assistance and patient satisfaction, malnutrition risk, body composition, grip strength, length of hospital stay and hospital mortality.


Options:
A: mean dietary intake of inpatients during a 24 hour period (end of year 1 and year 2)
B: Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA]) (42 days)
C: To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power. (5 days to 3 weeks intervention)
D: Return to hospital or death (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled, Crossover Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Severe Tourette Syndrome
Brief Summary: The purpose of this study is to investigate whether deep brain stimulation (DBS) of the globus pallidus internum (GPi) can alleviate tics in Gilles de la Tourette syndrome (GTS) and whether this treatment has any influence on social, psychological and behavioral disability and quality of life.


Options:
A: Reduction of Levomethadone (seven month)
B: Safety: Time to Reach a 4 Point Increase (Worsening) in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score (baseline to 24 months); Levodopa Equivalents, Change From Baseline (baseline to 24 months)
C: Change in Yale Global Tic Severity Scale (Three months after stimulation switched ON v three months after stimulation switched OFF)
D: Severity of tics

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).


Options:
A: Clinical and Endoscopic Remission. (8 weeks)
B: Proportion of subject who were relapse free after 6 months of treatment (6 months)
C: Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8 (Week 8)
D: Number of Participants With Clinical Response (Week 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Experimentation of New Organizational Models of Cervical Cancer Screening Programs, Upon the Use of HPV Test as First Level: Evaluation of the Methodologies Proposed of the Use of Self-sampling Devices to Recover Non-responders.
Brief Summary: The opportunity of a home, self-collected sample, opens the chance to remove some of the barriers that may discourage women from participating to screening programmes or performing HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as compared with tests performed at a clinic. It allows for privacy, reduces discomfort and women know nobody would have to handle their body.

Study hypothesis: The use of a self-sampler may increase the recovery of non-responders women at cervical cancer screening.


Options:
A: Receipt of Cervical Cancer screening via Pap Test (past 12-14 months (yes/no).)
B: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
C: performing a HPV test within 3 months since the recall letter (up to december 2012 (up to 3 months))
D: Proportion of participants self-reporting receipt of Pap test (One month post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis
Brief Summary: In the MOVING study should be examined, whether early therapeutic intervention with fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome as a comparative therapie with Interferon beta-1b (Extavia®), as measured by multifocal visual evoked potentials (mVEP) after 6 month compared to baseline.


Options:
A: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)
B: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)
C: Efficacy parameters
D: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain (Week 12 to Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial
Brief Summary: Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases referred to as comorbidities. Often these patients require health care by a variety of health care professionals from services linked to hospitals and in the community. Unfortunately, sometimes it may be difficult for these patients to receive appropriate care in a timely manner resulting in a trip to the emergency department. As well, patients may benefit from education that enables them to recognize early signs indicating they are getting sicker and to self-manage their disease. Our study will examine a strategy that includes a case manager who will make weekly phone contact with COPD patients with comorbidity that present either to the emergency department or are admitted to hospital. Weekly contact will focus on teaching patients to recognize worsening symptoms and self-management strategies. The case manager will work with patients, caregivers, community health care providers and hospital specialists to promote communication and optimize care delivery. The investigators will examine the impact of our intervention on the need for emergency department visits and hospital admission. The investigators will also examine the impact on patients' health related quality of life, number of COPD exacerbations, and disease progression.


Options:
A: Severity of dyspnea on the basis of modified medical research council dyspnea scale [mMRC] (6 months); Change in health status and symptom relief based on COPD assessment scale [CAT] (6 months); Change in quality of life (6 months); A change in the classification of COPD severity based on GOLD A-D (6 months); Change in patient reported symptoms (6 months); Number of participants with COPD related events and deaths during intervention and up to 12 months after inclusion (12 months); Number of participants with new hospitalization up 12 months after inclusion (12 months); Number of hospital days during intervention and up 12 months after inclusion (12 months); Number of health care visits during intervention and up to 12 months after inclusion (12 months)
B: Health related quality of life (Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)
C: The number of ED presentations (1 year after randomization.)
D: Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later. (1-2 months before the intervention and 18 months after the intervention); Difference in questionnaire about knowledge in COPD (questionnaire created by the research group)among the general practitioners that receive the education. (Immediately before the intervention and 12 months later.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial
Brief Summary: Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases referred to as comorbidities. Often these patients require health care by a variety of health care professionals from services linked to hospitals and in the community. Unfortunately, sometimes it may be difficult for these patients to receive appropriate care in a timely manner resulting in a trip to the emergency department. As well, patients may benefit from education that enables them to recognize early signs indicating they are getting sicker and to self-manage their disease. Our study will examine a strategy that includes a case manager who will make weekly phone contact with COPD patients with comorbidity that present either to the emergency department or are admitted to hospital. Weekly contact will focus on teaching patients to recognize worsening symptoms and self-management strategies. The case manager will work with patients, caregivers, community health care providers and hospital specialists to promote communication and optimize care delivery. The investigators will examine the impact of our intervention on the need for emergency department visits and hospital admission. The investigators will also examine the impact on patients' health related quality of life, number of COPD exacerbations, and disease progression.


Options:
A: Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools (12 months)
B: The number of ED presentations (1 year after randomization.)
C: Number of exacerbations (12 months)
D: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial
Brief Summary: Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases referred to as comorbidities. Often these patients require health care by a variety of health care professionals from services linked to hospitals and in the community. Unfortunately, sometimes it may be difficult for these patients to receive appropriate care in a timely manner resulting in a trip to the emergency department. As well, patients may benefit from education that enables them to recognize early signs indicating they are getting sicker and to self-manage their disease. Our study will examine a strategy that includes a case manager who will make weekly phone contact with COPD patients with comorbidity that present either to the emergency department or are admitted to hospital. Weekly contact will focus on teaching patients to recognize worsening symptoms and self-management strategies. The case manager will work with patients, caregivers, community health care providers and hospital specialists to promote communication and optimize care delivery. The investigators will examine the impact of our intervention on the need for emergency department visits and hospital admission. The investigators will also examine the impact on patients' health related quality of life, number of COPD exacerbations, and disease progression.


Options:
A: Oxygen Desaturation Index 4% (ODI4%) (Overnight, up to 8 hrs on nights 1 and 2)
B: Maximum Plasma Concentration at Steady-state (Cmax,ss) (Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.); Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss) (Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.)
C: The number of ED presentations (1 year after randomization.)
D: Trough FEV1 after 12 weeks of treatment (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial
Brief Summary: Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases referred to as comorbidities. Often these patients require health care by a variety of health care professionals from services linked to hospitals and in the community. Unfortunately, sometimes it may be difficult for these patients to receive appropriate care in a timely manner resulting in a trip to the emergency department. As well, patients may benefit from education that enables them to recognize early signs indicating they are getting sicker and to self-manage their disease. Our study will examine a strategy that includes a case manager who will make weekly phone contact with COPD patients with comorbidity that present either to the emergency department or are admitted to hospital. Weekly contact will focus on teaching patients to recognize worsening symptoms and self-management strategies. The case manager will work with patients, caregivers, community health care providers and hospital specialists to promote communication and optimize care delivery. The investigators will examine the impact of our intervention on the need for emergency department visits and hospital admission. The investigators will also examine the impact on patients' health related quality of life, number of COPD exacerbations, and disease progression.


Options:
A: Death (30 days, 3 months, 6 months); readmission (30 days, 3 months, 6 months); need for additional Prednisolone, additional antibiotics , NIV or life support machine (respirator) (30 days, 3 months, 6 months); Self-efficacy (3 days); Cognitive function (3 days and six weeks after discharge)
B: Hospital Readmission (12 months)
C: Total cost of hospitalization, $ (Day of admission to day of discharge)
D: The number of ED presentations (1 year after randomization.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial
Brief Summary: Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases referred to as comorbidities. Often these patients require health care by a variety of health care professionals from services linked to hospitals and in the community. Unfortunately, sometimes it may be difficult for these patients to receive appropriate care in a timely manner resulting in a trip to the emergency department. As well, patients may benefit from education that enables them to recognize early signs indicating they are getting sicker and to self-manage their disease. Our study will examine a strategy that includes a case manager who will make weekly phone contact with COPD patients with comorbidity that present either to the emergency department or are admitted to hospital. Weekly contact will focus on teaching patients to recognize worsening symptoms and self-management strategies. The case manager will work with patients, caregivers, community health care providers and hospital specialists to promote communication and optimize care delivery. The investigators will examine the impact of our intervention on the need for emergency department visits and hospital admission. The investigators will also examine the impact on patients' health related quality of life, number of COPD exacerbations, and disease progression.


Options:
A: COPD Assessment Test, CAT, to assess symtoms of COPD (Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
B: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)
C: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
D: The number of ED presentations (1 year after randomization.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)
Brief Summary: Blood transfusion in critical ill patients has been associated to several complications and worse outcome. Particularly in oncologic patients, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic patients. There are no prospective studies comparing outcomes between restrictive or liberal blood transfusion strategy in oncologic critical patients. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic critical patients - liberal or restrictive.


Options:
A: Functional ability (Measured 10 days after surgery + repeated measurement during 90 days after surgery)
B: Composite end-point of mortality and severe complication (30 days)
C: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
D: To compare mortality between groups 28 day after ICU admission (28 days after ICU admission)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)
Brief Summary: Blood transfusion in critical ill patients has been associated to several complications and worse outcome. Particularly in oncologic patients, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic patients. There are no prospective studies comparing outcomes between restrictive or liberal blood transfusion strategy in oncologic critical patients. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic critical patients - liberal or restrictive.


Options:
A: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)
B: Percentage compliance of q2weekly hemoglobins (3 months)
C: To compare mortality between groups 28 day after ICU admission (28 days after ICU admission)
D: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)
Brief Summary: Blood transfusion in critical ill patients has been associated to several complications and worse outcome. Particularly in oncologic patients, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic patients. There are no prospective studies comparing outcomes between restrictive or liberal blood transfusion strategy in oncologic critical patients. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic critical patients - liberal or restrictive.


Options:
A: Physical Fatigue (on day 3 postpartum)
B: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
C: Timed Up and Go-test (TUG)in seconds. (30 days)
D: To compare mortality between groups 28 day after ICU admission (28 days after ICU admission)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Second-line, Single Arm, Phase II Clinical Study With Tremelimumab, a Fully Human Anti-CTLA-4 Monoclonal Antibody as Monotherapy in Patients With Unresectable Malignant Mesothelioma
Brief Summary: The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.


Options:
A: Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST) (Weeks 24)
B: To determine the objective response (Weeks 24)
C: Feasibility in terms of 90-day progression-free survival
D: % of patients with controled disease (responder and stable patients) at 6 months (3-month)

Answer: A