TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Trial of IL-2/IFN-α Plus Bevacizumab Versus IL-2/IFN-α in Metastatic Renal Cell Carcinoma (mRCC) - Danish Renal Cancer Group (DARENCA) Study-1
Brief Summary: The purpose of this study is to determine whether interleukin-2, interferon-alpha in combination with bevacizumab are effective in the treatment of metastatic renal cell carcinoma (mRCC).


Options:
A: Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period (From randomization of the first subject until 15 months later, assessed every 8 weeks)
B: Progression-free Survival (PFS) by Independent Imaging Review (IIR) (From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months))
C: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)
D: Progression free survival, PFS (This is defined as the time between date of randomisation and the first date of documented disease progression or date of death due to any cause.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: China-JD Program: A Multi-centre Demonstration Project to Evaluate the Effectiveness and Acceptability of the Joint Asia Diabetes Evaluation (JADE) and DIAbetes MONitoring Database (DIAMOND) Programs in Asian Type 2 Diabetic Patients
Brief Summary: Quality diabetes care requires a team approach and informed decisions of patients and care providers. Several lines of evidence suggests that a protocol-driven care model delivered by trained staff with focus on periodic assessments, reinforcement of patient compliance and attainment of multiple treatment targets reduces risk of cardio-renal complications and early death in type 2 diabetes.

The investigators hypothesize that the use of state of the art information technology to record, manage and analyze the large amount of clinical information generated during various consultation visits will improve the effectiveness and efficiency in implementing these care protocols through decision support and regular feedback to both patients and care team.


Options:
A: Pre- to post-implementation change in HbA1c. (Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months)
B: Hemoglobin A1c
C: Percentage of patients who attain 2 or more of the 'ABC' targets (12 months)
D: Hemoglobin A1c (1 year after date of discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hypothermic Machine Preservation of Extended Criteria Liver Allografts for Transplantation
Brief Summary: This is a study comparing a technique of continuous circulation to the liver as a means of preventing liver damage during transportation to the transplant hospital. This new technique of Machine Perfusion (MP) will be compared to the standard technique where the liver is maintained in a bag of solution on ice without circulation. The investigators will evaluate and compare the outcomes of the transplants with the new technique to the standard technique. There will be 24 MP patient's in the study. The investigators have previously used this technique with success in 20 human liver transplant patients. The investigators think there will be a benefit in terms of less damage to and better function of the donor liver which will result in faster recovery for the patients. This protective effect may allow us to successfully transplant more patients and prevent people from dying while waiting for a liver transplant.


Options:
A: Patient Survival at One Year Post-Transplantation (Post-Operative Day 1 to Day 365); Graft Survival at One Year Post-Transplantation (Post-Operative Day 1 to Day 365)
B: Early graft injury (During the first week postoperatively (absolute and relative delta))
C: The incidence of symptomatic non-anastomotic biliary strictures (NAS) (6 months)
D: Participants With Early Liver Allograft Dysfunction (EAD) (7 days); Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Postpartum Prophylaxis for PE Randomized Control Trial Pilot: A Pilot Study Assessing Feasibility of a Randomized, Open-label Trial of Low-Molecular-Weight-Heparin for Postpartum Prophylaxis in Women at Risk of Developing Venous Thromboembolism
Brief Summary: The purpose of this study is to determine if it is feasible to conduct a multi-center randomized trial to determine whether a blood thinner, low-molecular-weight-heparin (LMWH), is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.


Options:
A: Feasibility of Recruitment and Trial Operations. (4 months)
B: Fetal loss (From 12 weeks to 42 weeks gestational age)
C: Anti Xa Level (3.5-4 hours after the third dose of Lovenox (enoxaparin))
D: Successful pregnancy outcome

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Visual Reconstitution Therapy After Optic Neuritis
Brief Summary: Incomplete remission after an optic neuritis attack is not uncommon. Visual reconstitution therapy is a software-based approach that has been shown to substantially improve residual visual field deficits in patients with pre- and postchiasmatic lesions.

The primary hypothesis of this randomized, controlled clinical trial is, that visual reconstitution therapy is superior to active comparator treatment in improving the visual field after optic neuritis.


Options:
A: Participants will be given the following assessment tests at 4 different times during the assessment (at baseline, after 6 weeks, after 12 weeks, and after 18 weeks): eye tracking measures, daily performance measures and reading measures.
B: activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) (5 and 17 weeks); distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ)) (5 and 17 weeks)
C: VA LV VFQ-48 Reading Domain Scores (4 months from baseline)
D: Visual field (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Administration of Erythromycin and Brain Protection
Brief Summary: Neurological complications occur in open heart surgery with a frequency of 40% and they range from major neurological deficits (due to a stroke) to neurocognitive and behavioral disorders. This study aims to determine if erythromycin, a worldwide known antibiotic, protects the brain from damage when given in high doses before and during open heart surgery.

The investigators consume that high dose of erythromycin will protect the brain with a pharmacological preconditioning against the global ischemia during the perioperative period of heart surgery.


Options:
A: biochemical markers of brain ischemia and intraoperative cerebral oxymetry data (September 2010)
B: Reduction of LV dilation (six months versus baseline LV end-diastolic volume index by 2D-echocardiogram [echo]) more than 50% in the treated group in comparison to the placebo group (6 months)
C: Composite consisting of: death regardless of cause; non-fatal AMI or; unstable angina pectoris whichever occurred first
D: Angiographic restenosis (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dynamic Light Application to Prevent ICU Acquired Delirium
Brief Summary: Rationale: Delirium is a frequently encountered problem in ICU patients and leads to increased morbidity and mortality; Delirium in the ICU is associated with sleep deprivation which is among others caused by a disrupted circadian rhythm; Dynamic Light application aims at restoring a proper circadian rhythm by rhythmically alternating light intensity and has shown beneficial effects in sleep quality. Whether DLA improves sleep quality and reduces delirium incidence in ICU patients is not known

Goals/endpoints:

To evaluate the feasibility of dynamic light application in the ICU and to study the effects of dynamic light application on the incidence of delirium, duration of mechanical ventilation, the number of ICU and hospital days, and mortality in a mixed population of medical and surgical ICU patients. In a subgroup of patients with a high risk of developing delirium, markers of circadian rhythm, inflammation and brain damage and post ICU HRQoL will be assessed Study design: prospective randomized single centre trial Study population: adult ICU patients \> 18 years old with an expected duration of stay of more than 24 hours Intervention: Patients will be randomized between Standard Care or Standard Care + DLA; When receiving standard care, normal lighting settings will be used in that patient room, which can be controlled by the medical personnel; In the rooms of patients randomized to the DLA group, DL is applied with a changing intensity during the day according to a fixed rhythm, which is regulated centrally. In addition when necessary, an intervention light can be used which can be operated in the patient room.

Study parameters/endpoints: incidence of delirium as measured by the CAM-ICU; duration of mechanical ventilation, ICU and total hospital mortality; ICU and hospital LOS; Serum levels of inflammatory markers and markers of brain damage, urinary levels of markers of circadian rhythm, data of HRQoL questionnaires and total light exposure in both groups


Options:
A: To assess sleep quality, fatigue and daytime activity during the 4 to 6-day hospitalization as being more positive for patients randomized to the sleep environment intervention months as compared to those randomized to the standard care months (Within 6 -10 months)
B: Richmond Agitation-Sedation Scale (RASS) (3 days)
C: delirium outcome (duration of ICU stay(average duration 5 days))
D: Acceptability and feasibility of the comfort intervention (Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dynamic Light Application to Prevent ICU Acquired Delirium
Brief Summary: Rationale: Delirium is a frequently encountered problem in ICU patients and leads to increased morbidity and mortality; Delirium in the ICU is associated with sleep deprivation which is among others caused by a disrupted circadian rhythm; Dynamic Light application aims at restoring a proper circadian rhythm by rhythmically alternating light intensity and has shown beneficial effects in sleep quality. Whether DLA improves sleep quality and reduces delirium incidence in ICU patients is not known

Goals/endpoints:

To evaluate the feasibility of dynamic light application in the ICU and to study the effects of dynamic light application on the incidence of delirium, duration of mechanical ventilation, the number of ICU and hospital days, and mortality in a mixed population of medical and surgical ICU patients. In a subgroup of patients with a high risk of developing delirium, markers of circadian rhythm, inflammation and brain damage and post ICU HRQoL will be assessed Study design: prospective randomized single centre trial Study population: adult ICU patients \> 18 years old with an expected duration of stay of more than 24 hours Intervention: Patients will be randomized between Standard Care or Standard Care + DLA; When receiving standard care, normal lighting settings will be used in that patient room, which can be controlled by the medical personnel; In the rooms of patients randomized to the DLA group, DL is applied with a changing intensity during the day according to a fixed rhythm, which is regulated centrally. In addition when necessary, an intervention light can be used which can be operated in the patient room.

Study parameters/endpoints: incidence of delirium as measured by the CAM-ICU; duration of mechanical ventilation, ICU and total hospital mortality; ICU and hospital LOS; Serum levels of inflammatory markers and markers of brain damage, urinary levels of markers of circadian rhythm, data of HRQoL questionnaires and total light exposure in both groups


Options:
A: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
B: delirium (during admission at the critical care)
C: Ventilator free-days (28 days)
D: delirium outcome (duration of ICU stay(average duration 5 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
Brief Summary: In this project we will conduct a pilot study of a brief intervention to reduce teen tobacco, alcohol and drug use that primary care dental practitioners can provide in their offices.


Options:
A: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
B: Percent days abstinent of tobacco, alcohol and drugs (Past 90 days)
C: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
D: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone Assessment and Skill-Building Intervention for Stroke Caregivers
Brief Summary: The purpose of this study is to test the efficacy of the revised Telephone Assessment and Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR) intervention in family caregivers of stroke survivors. We will also test if TASK II intervention effects on primary outcomes (depressive symptoms, caregiving-related negative life changes, unhealthy days) are mediated through effects on secondary outcomes (task difficulty, optimism, threat appraisal). Comparative costs and outcomes for the TASK II and ISR interventions will also be explored.


Options:
A: Increase in Adherence and Control of Stroke Risk Factors (1, 3, 6, 9 and 12 months)
B: Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9) (Change in depressive symptoms from baseline to 8 weeks); Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS) (Change in caregiving-related negative life changes from baseline to 8 weeks); Unhealthy days: Unhealthy Days (UD) (Change in unhealthy days from baseline to 8 weeks)
C: Difference in physical activity scale for the elderly (24 months)
D: blood pressure (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial on the Effect of Guided Imagery and Progressive Muscle Relaxation for the Management of Pain, Stress, Anxiety and Depression as a Means to Improve the Psychological Well-being and the Quality of Life for Patients With Breast and Prostate Cancer
Brief Summary: The purpose of this study is to determine whether Guided Imagery and Progressive Muscle Relaxation techniques are effective in the management of pain, fatigue, nausea-vomit, anxiety and depression in patients with either prostate or breast cancer.

This study includes a total of 200 patients with prostate and breast cancer randomly assigned to either a control or intervention group.

The intervention group received in total 4 sessions of Guided Imagery (protocol floating on a cloud) and Progressive Muscle Relaxation (breathing exercises and use of 11 groups of muscle progressively tensing and relaxing).

Measurements included the assessment of pain, fatigue, nausea-vomit, depression, anxiety and quality of life. Additionally, saliva samples were collected prior and after the sessions as to assess saliva cortisol and saliva α-amylase.

The same measurements were received by the patients of the control group as to allow comparisons.


Options:
A: Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4) (8 weeks, 6 months)
B: Pain (From baseline until 6 months)
C: Change in quality of life (T0: before chemotherapy (week 0); T1: in the middle of chemotherapy (i.e. week 4 to 10); T2: three weeks after last cycle of chemotherapy (i.e. week 13 to 20).)
D: Stress (20 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
Brief Summary: Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose.

The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.


Options:
A: skin blood flow response (perfusion units, PU) (immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points))
B: Pain scores assessed by the PIPP score (The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.)
C: Pain-specific event related potential (Isolated within the one-minute window post-procedure.)
D: The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R). (Change from baseline 30 seconds post painful procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
Brief Summary: Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose.

The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.


Options:
A: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)
B: N/A
C: Pain Profile (During the Procedure)
D: Pain scores assessed by the PIPP score (The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
Brief Summary: Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose.

The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.


Options:
A: Pain scores assessed by the PIPP score (The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.)
B: skin blood flow response (perfusion units, PU) (immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points))
C: Premature Infant Pain Profile (PIPP) (At the moment of painful procedure)
D: The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score (PIPP score before, during and after eye exam)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
B: N/A
C: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 (12 weeks)
D: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.


Options:
A: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (0-12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (0 - 12 Weeks)
B: Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43 (Through day 43); Part B: All Treatment Adverse Events Reported for Safety Evaluation (85 days); Part A: All Treatment Adverse Events Reported for Safety Evaluation (Cohort 1-4 43 days, Cohort 5-8 64 days)
C: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
D: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)

Answer: D