TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients Without Inhibitors
Brief Summary: This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emphasis on efficacy, safety, and pharmacokinetics.


Options:
A: Serious and non-serious AEs (4 weeks after infusion with BAX 855 and ADVATE)
B: Annualized Bleeding Rate (ABR) for Treated Bleeds (From Baseline to at least 24 weeks (median [min-max] efficacy periods for Arm C: 24.00 [14.4-25.0] weeks; Arm A: 29.57 [17.3-49.6] weeks; Arm B: 31.29 [3.3-50.6] weeks; Arm D: 33.14 [18.4-48.6] weeks))
C: Number of Participants With Treatment Emergent Adverse Events (Approximately up to 7 years after dosing); Number of Participant With Median FVIII Activity Levels >= 5 IU/dL Using Chromogenic Substrate Assay (CSA) (Week 13-16 post-BMN 270 infusion); Median FVIII Activity as Measured by Chromogenic Substrate Assay During Week 13-16 Post-BMN 270 Infusion (Week 13-16 post-BMN 270 infusion)
D: To assess the safety of systemic administration of a novel self-complementary AAV vector in adults with severe hemophilia B at up to four different dosage levels. (15 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation
Brief Summary: Postoperative sore throat (POST) is a common problem following the use of endotracheal intubation during general anaesthesia. It leads to dissatisfaction and discomfort after surgery and can delay a patient's return to normal routine activities. POST has been rated by patients as the eighth most adverse effect in the postoperative period. The incidence of sore throat after endotracheal intubation varies from 14.4-90%. Laryngoscopy and tracheal intubation also leads to hemodynamic stress response. The response can be deleterious in patient with or without cardiac disease. It is related to the degree of manipulation of the airway during endotracheal intubation and has been studied during intubation for some equipment used for endotracheal intubation


Options:
A: intubation success (at intubation; < 120 seconds)
B: Incidence of post operative sore throat (0 hours after surgery); Incidence of post operative sore throat (6 hours after surgery); Incidence of post operative sore throat (12 hours after surgery); Incidence of post operative sore throat (24 hours after surgery); Severity of post operative sore throat (0 hours after surgery); Severity of post operative sore throat (6 hours after surgery); Severity of post operative sore throat (12 hours after surgery); Severity of post operative sore throat (24 hours after surgery); Mean arterial pressure after endotracheal intubation (1 minute after surgery); Mean arterial pressure after endotracheal intubation (2 minutes after surgery); Mean arterial pressure after endotracheal intubation (3 minutes after surgery); Mean arterial pressure after endotracheal intubation (4 minutes after surgery); Mean arterial pressure after endotracheal intubation (5 minutes after surgery)
C: Maximum cervical spine motion (degree) (During tracheal intubation time, an expected average of 90 seconds)
D: CERVICAL MOTIONS (January 2011 and December 2012)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Influence of Postoperative Analgesia on Systemic Inflammatory Response and Postoperative Cognitive Disfunction in Elderly Patients After Surgical Repair of Femoral Fractures
Brief Summary: The purpose of this study is to determine whether epidural levobupivacaine applied for the purpose of post-operative analgesia compared to systemic analgesia with morphine leads to better pain control, stronger suppression of the inflammatory response and the production of inflammatory mediators, faster recovery of patients and consequently less incidence of postoperative cognitive dysfunction (POCD) in elderly patients after surgical treatment of femoral fractures.


Options:
A: Number of Participants Reporting at Least One NRS Rating (30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.)
B: Consumption of opioids
C: Interleukin-6 Concentration in Peripheral Blood. (Before, 24 and 72 hours after the surgery); Changes in Cognitive Function (Before, 24,48,72,96 and 120 hours after the surgery)
D: Respiratory complications (During hospital stay, up to 1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Clinical Trial on the Treatment of Caries Lesions Using Resin or Glass Ionomer Sealants in Permanent Teeth
Brief Summary: This study aimed to test whether sealing microcavitated ICDAS 3 carious lesions in permanent molars may be arrested by sealing using two different types of materials; a glass ionomer and a resin sealant. A Randomized controlled clinical trial was designed. Children between 6 and 12 years old were recruited and a total of 150 ICDAS 3 lesions in first permanent molars were allocated to one of the two arms of the study. Clinical and radiographic lesion progression were the main outcome. Integrity of the material and retention were secondary outcomes. A follow up period of 24 months with check-ups at 6 and 12 months was considered.


Options:
A: The survival of the tooth with vital pulp and without apical radiolucency. The x-ray evaluation and the clinical sensibility test are carried out by a blinded observer. (1 year after inclusion in the CAP-2)
B: restauration evaluation (18 months)
C: Number of lesions that evidence progression by a higher ICDAS code. The score will be expressed as percentage of progression among all the treated lesions. (24 months)
D: cold pulp test (signalling the nerve of the pulp of the tooth by cold application) (One year follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Kg-Free: an Acceptance, Mindfulness and Compassionate-based Intervention for Women Struggling With Their Weight: A Randomized Controlled Trial
Brief Summary: This study aims to test the efficacy and feasibility of an acceptance, mindfulness and compassionate-based intervention for women with overweight and obesity without binge-eating disorder (Kg-Free). Kg-Free intervention comprises 10 weekly group sessions plus 2 booster fortnightly sessions (31/2months) 2h30 hours each, run in small groups at Coimbra's University Hospital. The main goal of Kg-Free intervention is to reduce weight self-stigma and unhealthy eating behaviours and promote quality-of-life by targeting weight-related experiential avoidance and self-criticism patterns. The intervention focuses on fostering a greater awareness and ability to be in contact, tolerate and accept all internal experiences (even the unwanted ones, such as craving for food, fatigue, stigma and shame), rather than trying to avoid, control or change them. Additionally, the intervention intents for participant's to develop a compassionate attitude towards themselves, especially during challenging times in order to decrease shame and self-criticism.


Options:
A: frequency of eating in response to cravings (primary mechanistic outcome) (change from baseline to 6 months)
B: Adherence to implementing a meditation program in the perioperative period (Baseline through 1 month post surgery)
C: Changes in weight self-stigma (9 months (from Baseline to 6-months follow-up)); Changes in eating behaviours (9 months (from Baseline to 6-months follow-up)); Changes in obesity-related quality-of-life (9 months (from Baseline to 6-months follow-up))
D: Perceived Stress Scale (PSS-10) scores (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Safety, and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Parallel-Arm, Multiple-Dose, Active Comparator Trial
Brief Summary: To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in patients with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)
B: Long-term Safety and Tolerability of Secukinumab (Week 268)
C: The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16 (Week 16)
D: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Safety, and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Parallel-Arm, Multiple-Dose, Active Comparator Trial
Brief Summary: To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in patients with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R (Week 16 of Period R)
B: The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16 (Week 16)
C: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (Week 12)
D: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
Brief Summary: This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who require pharmacotherapy for NAS will receive a methadone wean, and half will receive a morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be studied.


Options:
A: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
B: Length of Hospital Stay (assessed at hospital discharge, approximately 7-30 days)
C: Length of Hospital Stay (LOS) (Participants will be monitored during their entire hospitalization, expected mean 22 days.)
D: Cumulative dose of morphine required to treat NAS. (14 days of age); Highest dose of morphine required to treat NAS. (14 days of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC).

The primary hypotheses of this study are:

1. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
2. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).


Options:
A: Anti-tumor Activity as Measured by Median Progression Free Survival Time (24 Months)
B: Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ) (End of treatment of both study drugs (maximum of 22 weeks)); Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire (End of treatment of both study drugs (maximum of 22 weeks))
C: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.)
D: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review (Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)); Overall Survival (OS) (Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC).

The primary hypotheses of this study are:

1. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
2. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).


Options:
A: Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death) (12 months)
B: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review (Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)); Overall Survival (OS) (Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months))
C: Progression-free Survival (PFS) (Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years)
D: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentric, Randomized, Open Label Study on Comparison of Pancreatic Beta Cell Recovery and Preservation in Type 2 Diabetic Patients Treated With DPP-4 Inhibitor (Vildagliptin) and Metformin
Brief Summary: This study is a multicentre, randomized, open label on comparison of pancreatic beta cell recovery and preservation of Vildagliptin 100mg daily and Metformin (1000 - 2500mg) daily for 96 weeks in 203 patients with type 2 diabetes that will be conducted in four centers in Chennai. The primary outcome measures will be to compare the effects of Vildagliptin versus Metformin on Pancreatic beta cell function in type 2 diabetic patients as measure by Insulin secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L). The secondary outcomes will be effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of Percent HbA1c reduction, C-peptide responses, Insulin to glucose ratios, Reduction in fasting plasma glucose (FPG), 2hr postprandial glucose (PPG) from baseline, Improvement in insulin sensitivity, Improvement in oral disposition index, Percentage of patients reaching the glycemic target of (i) HbA1c ≤ 6.5% and (ii)HbA1c ≤ 7.0%, in the overall study population and General safety in terms of occurrence of adverse events


Options:
A: Change From Baseline in HbA1c at Week 80 (Baseline and Week 80)
B: Changes in Insulin secretion rate (Baseline and 96 weeks)
C: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 weeks)
D: Hypoglycaemic Events (78 weeks plus 1 week of follow-up); Change From Baseline to Week 78 in Lipid Parameters (Weeks 1 and 78); Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements (78 weeks plus 1 week of follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation
Brief Summary: Prospective, randomized, multicentre phase III study to evaluate the level and type of information requested by patients or families during a palliative care consultation after they have been given the Booklet-Question List (BQL).


Options:
A: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)
B: preferences for CPR (within one hour after oncology visit)
C: Aim 1: feasibility and acceptability of learning Motivational Interviewing techniques by palliative care clinicians (Through study completion, an average of 1 year.)
D: The number of questions asked or the concerns expressed that elicit a medical comment by the patient or the family during the palliative care consultation. (one month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy Study of Neural Progenitor Cell Transplantation and Paracrine Factors From Human Mesenchymal Stem Cells to Treat Newborn With Hypoxic-ischemic Encephalopathy
Brief Summary: The purpose of this study is to investigate the efficacy and safety of allogenic neural progenitor cell and paracrine factors of human mesenchymal stem cells for patients with moderate/severe Hypoxic-Ischemic Encephalopathy


Options:
A: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
B: Number of participant with adverse reaction (12 weeks from the day of treatment)
C: Neonatal Behavioral Neurological Assessment (14days after birth); number of adverse events (7days after cell or factor injection); Neonatal Behavioral Neurological Assessment (28days after birth)
D: Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. (during infusions: first 18 postnatal days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx T1-T2N0 Operable : Comparison of the Reference Strategy Based on a the Systematic Lymph Node Dissection Versus the Strategy Based on the Technique of Sentinel Lymph Node.
Brief Summary: Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated surgically with systematic lymph node dissection while in 70%, there is no lymph node metastasis. The technique of identifying the sentinel node (GS) is validated for these tumors because the status of the sentinel node is predictive of the other nodes status in the neck. This helps to diagnose the presence of metastases without lymph node dissection and thus select patients requiring a treatment node. However, the oncological and functional results of a therapeutic strategy based on identifying the GS is unknown.

This open-label randomized multicenter clinical trial aims to compare the oncologic and functional outcome of two strategies : the current management versus the management based on the sentinel lymph node.

The hypothesis is based on a nodal control difference at 2 years in both arms not exceeding 10%. The medico-economic analysis will be conducted in two stages : a classic stage on 2 years with estimated incremental cost-effectiveness and incremental cost-utility, then a step with log term modeling.

A reduction in morbidity and treatment costs in the sentinel node arm are expected in this study.


Options:
A: Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op. (6 months per patient)
B: Nodal recurrence rate (24 months after the surgery)
C: Spinal accessary nerve function (2 years)
D: Overall Survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Using an Interactive System, a Paper and Pencil Program or Conventional Methodologies in the Rehabilitation of Stroke Patients: a Randomised Controlled Trial
Brief Summary: Virtual Reality allows the integration of both cognitive and motor rehabilitation in a more ecologically valid context. The purpose of this study is to determine whether this methodology has more impact on stroke rehabilitation than a paper and pencil personalised program and conventional therapy, which is motor-focused.


Options:
A: Paced auditory Serial Attention Test (PASAT) (change from baseline after each 3 treatment sessions, change from baseline after 20 hours of training, change from baseline after 6 months and change from baseline after 1 year); Work Ability Index (WAI) (change from baseline after 20 hours of training, change from baseline after 3 months and change from baseline after 1 year)
B: Montreal Cognitive Assessment Test (MoCA) (Six months)
C: Change from baseline in the Montreal Cognitive Assessment (Baseline, End (4-6 weeks) and 8-weeks follow-up)
D: Functionality in Activities of Daily Living (Changes in Scores Approach) (Baseline, 6 months and 12 months); Quality of Life (Changes in Scores Approach) (Baseline, 6 months and 12 months); Quality of Life (Clinically Significance Approach) (Baseline, 6 months and 12 months)

Answer: C