TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors
Brief Summary: This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.


Options:
A: EULAR individual response (12 months)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)
C: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Effect of Monitoring Cancer Patients Using the Distress Thermometer on Levels of Distress and Health Service Costs - a Randomised Controlled Trial
Brief Summary: The diagnosis and treatment of cancer has been shown to lead to very high levels of distress among patients. Although treatments for a range of different cancers have become much better in recent years, the distress that accompanies diagnosis and treatment can have serious negative effects for patients. Research has shown that, for a number of reasons, patients find it difficult to inform healthcare professionals about the cause of their distress whether it is physical (e.g. pain), psychological (anxiety and depression), personal partners and family) or social (finances). Also, medical staff often fail to detect even high levels of distress. This means that a great deal of distress is not being treated and this may lead to more hospital and GP visits, and dissatisfaction with care. The Distress Thermometer and Problem List (DT\&PL) is a simple method of identifying distress in cancer patients using the familiar image of a thermometer. It offers patients a list of common treatment-related difficulties to help them identify any problems that cause distress. A trained staff member uses the DT\&PL to discuss with the patient different options for addressing each concern: directly where possible (action taken by the patient or the staff member present) or leading to a referral to a specialist where necessary. Our research aims to measure whether the DT\&PL is effective in quickly identifying and treating cancer-related distress and therefore preventing longer-term problems developing. The investigators also want to know whether patients find it helpful to complete the DT\&PL and whether using the DT\&PL saves NHS time and money.


Options:
A: Profile of Mood States (POMS) (1, 6, 12 months post randomisation)
B: Subscale quality of life of the questionnaire: EORTC QLQ C30 (After each treatment completion, during follow up; first year every 3 months, second year every 6 months)
C: The primary effect outcome measurement is the number and type of referred patients with psychosocial problems to psychosocial caregivers and type of referrals with respect to psychosocial problems. (Is measured at three (T3) and twelve (T4) months after first measurement)
D: The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life). (16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Alternate Day Fasting for Weight Loss, Weight Maintenance and Cardio-protection
Brief Summary: The proposed research will demonstrate that alternate day modified fasting (ADMF) is a suitable alternative to daily calorie restriction (CR) for weight loss, weight maintenance, and heart disease prevention. Since many overweight and obese individuals find it difficult to adhere to daily CR, this diet option may improve adherence with these dietary restriction protocols. This, in turn, will allow a greater percent of the overweight and obese population to lose weight, maintain weight loss, and prevent future occurrences of coronary heart disease.


Options:
A: Changes in body weight (Kilograms) (Baseline and 16 weeks); Change in insulin resistance (Baseline and 16 weeks)
B: Body Weight (Baseline to month 12)
C: Weight loss (1 year)
D: Body weight (52 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.
Brief Summary: The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is systemic absorption of these topical steroids. The investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.


Options:
A: Percent of Participants Who Were Histologic Responders (Week 16); Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation (Baseline, Week 16)
B: Mean Eosinophil Count (Week 16)
C: To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients (8 weeks)
D: Tissue Eosinophil Counts (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Validating a Delirium Prediction Model for Critically Ill Patients
Brief Summary: The objective of this study is to determine the incidence of delirium in adults patients who are admitted at the critical care unit of a Dutch University Hospital with the mapping of relevant delirium risk factors The primary aim is to validate the investigators' developed delirium prediction model for critical care patients.

A secondary aim is to find differences between delirious patients and non-delirious patients on different aspects of diagnostics, treatment and care, outcome, length of stay, and inflammation.

According to Dutch law, the need to obtain informed consent was waived by the Committee on Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).


Options:
A: Delirium/Coma Free Days (DCFDs) (14 days)
B: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
C: delirium (during admission at the critical care)
D: the rate of hematological remission; the rate of molecular remission; the kinetics of the MRD of PML/RARa during and after ATO

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Dance on Patients With Fibromyalgia
Brief Summary: The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.

Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.


Options:
A: Pain severity (Week 3)
B: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
C: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
D: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Dance on Patients With Fibromyalgia
Brief Summary: The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.

Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.


Options:
A: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
B: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)
C: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
D: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Dance on Patients With Fibromyalgia
Brief Summary: The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.

Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.


Options:
A: Pain (10 sessions, in 5 weeks, 2 times a week)
B: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
C: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
D: Muscle function (2010-2013)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Dance on Patients With Fibromyalgia
Brief Summary: The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.

Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.


Options:
A: Pain severity (Week 3)
B: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)
C: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
D: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Dance on Patients With Fibromyalgia
Brief Summary: The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.

Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.


Options:
A: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
B: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
C: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
D: Muscle function (2010-2013)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Hydroxyethyl Starch 130/0.4 Compared With Balanced Crystalloid Solution on Mortality and Kidney Failure in Patients With Severe Sepsis
Brief Summary: * By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill.
* High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis.
* Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.
* HES 130/0.4 is largely unstudied in ICU patients.
* This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis.
* The trial will provide important data to all clinicians who resuscitate septic patients.


Options:
A: Mean Change in Protein C Levels From Day 1 to Day 7 (Day 1, Day 7)
B: Mortality or dialysis-dependency (90 days)
C: 90-day mortality (90 day)
D: 28-Day All-Cause Mortality (Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Hydroxyethyl Starch 130/0.4 Compared With Balanced Crystalloid Solution on Mortality and Kidney Failure in Patients With Severe Sepsis
Brief Summary: * By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill.
* High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis.
* Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.
* HES 130/0.4 is largely unstudied in ICU patients.
* This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis.
* The trial will provide important data to all clinicians who resuscitate septic patients.


Options:
A: To evaluate complications (renal failure, hepatic encephalopathy, hyponatremia, infection and gastrointestinal bleeding) in patients with cirrhosis awaiting for liver transplant. (When 97 patients are included (% of the whole population))
B: renin-angiotensin-aldosterone activation (4-6 days)
C: Renal failure rate (During hospitalization); Renal failure rate (at 3 month)
D: Mortality or dialysis-dependency (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Hydroxyethyl Starch 130/0.4 Compared With Balanced Crystalloid Solution on Mortality and Kidney Failure in Patients With Severe Sepsis
Brief Summary: * By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill.
* High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis.
* Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.
* HES 130/0.4 is largely unstudied in ICU patients.
* This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis.
* The trial will provide important data to all clinicians who resuscitate septic patients.


Options:
A: baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial (survival at 48 hours, hospital discharge, 30 days and 4 months); randomization compliance rate (duration of enrolment); ease of protocol implementation in the out-of-hospital setting (duration of study); adverse event rate of hypertonic saline dextran infusion (duration of study)
B: 28 Day Survival (28 days from time of Emergency Department (ED) arrival)
C: Mortality or dialysis-dependency (90 days)
D: Sublingual microcirculation (24 hour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Hydroxyethyl Starch 130/0.4 Compared With Balanced Crystalloid Solution on Mortality and Kidney Failure in Patients With Severe Sepsis
Brief Summary: * By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill.
* High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis.
* Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.
* HES 130/0.4 is largely unstudied in ICU patients.
* This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis.
* The trial will provide important data to all clinicians who resuscitate septic patients.


Options:
A: Mortality or dialysis-dependency (90 days)
B: Sublingual microcirculation (24 hour)
C: Mortality (28 day); Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
D: All cause mortality (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Orthokeratology for Myopic Control in Chinese Children - a Randomized Clinical Trial
Brief Summary: The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.


Options:
A: Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study (2 years)
B: Spherical equivalent refraction determined by cycloplegic autorefraction
C: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (Baseline to 3 years); Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (3 years)
D: Determine the change in cycloplegic axial length in the study and control groups (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Orthokeratology for Myopic Control in Chinese Children - a Randomized Clinical Trial
Brief Summary: The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.


Options:
A: Changes in Cycloplegic Autorefraction in One Year. (One year)
B: Spherical equivalent refraction determined by cycloplegic autorefraction
C: Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study (2 years)
D: Change in the spherical equivalent refractive error relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months); Change in axial length relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months); Measurement of corneal curvature (keratometry)relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The European Quality of Care Pathways Study: The Impact of a Care Pathway for Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) : an International Cluster Randomized Controlled Trial." (Www.E-P-A.Org)
Brief Summary: Care pathways, a complex intervention to (re)organise, standardize and evaluate care processes, are used worldwide and in different kinds of settings. Although their international use, the impact is unclear. The European Quality of Care Pathways Study is the first international cluster Randomized Controlled Trial on the effect of care pathways for COPD patients.

The hypothesis is that teams who work with care pathways for COPD patients deliver care that is more compliant to evidence based key interventions, have better patient outcomes and higher scores on team indicators than teams who do not work with care pathways.


Options:
A: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)
B: Medicines adherence (Change in adherence from 6 weeks to 10 weeks and 26 weeks); Cost effectiveness (6 months); Operation of the NMS (1 year from first recruited patient)
C: Hospital readmission within 30 days of discharge (30 days)
D: Readmission rate (6 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The European Quality of Care Pathways Study: The Impact of a Care Pathway for Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) : an International Cluster Randomized Controlled Trial." (Www.E-P-A.Org)
Brief Summary: Care pathways, a complex intervention to (re)organise, standardize and evaluate care processes, are used worldwide and in different kinds of settings. Although their international use, the impact is unclear. The European Quality of Care Pathways Study is the first international cluster Randomized Controlled Trial on the effect of care pathways for COPD patients.

The hypothesis is that teams who work with care pathways for COPD patients deliver care that is more compliant to evidence based key interventions, have better patient outcomes and higher scores on team indicators than teams who do not work with care pathways.


Options:
A: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
B: Readmission rate (6 month)
C: Adherence to COPD guidelines (Twelve months post intervention)
D: Improvement tolerance capacity (4 months and 6 months)

Answer: B