TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of Chronic Obstructive Pulmonary Disease
Brief Summary: This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.

It is anticipated that there will be 123 participants enrolled in this study across two experimental arms and one control arm. Participants will be in the study for 6 months and the study will run for 1 year a Markham-Stouffville Hospital. The primary outcome is the participants' self-management and activation which will be measured using The Partners in Health (PIH) scale, a validated scale measuring the current status of self-management, with items on knowledge of the condition and skills to monitor and respond to symptoms.


Options:
A: Self-management and Activation (6 Months)
B: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations
C: Time to first event (at 6 months)
D: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of Chronic Obstructive Pulmonary Disease
Brief Summary: This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.

It is anticipated that there will be 123 participants enrolled in this study across two experimental arms and one control arm. Participants will be in the study for 6 months and the study will run for 1 year a Markham-Stouffville Hospital. The primary outcome is the participants' self-management and activation which will be measured using The Partners in Health (PIH) scale, a validated scale measuring the current status of self-management, with items on knowledge of the condition and skills to monitor and respond to symptoms.


Options:
A: Self-management and Activation (6 Months)
B: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
C: Measure of physical activity (Change from Baseline to Week 12)
D: Difference in COPD admission rates and death over one year between patients treated with supported self-management, in addition to usual care, and those treated with usual care alone? (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of Chronic Obstructive Pulmonary Disease
Brief Summary: This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.

It is anticipated that there will be 123 participants enrolled in this study across two experimental arms and one control arm. Participants will be in the study for 6 months and the study will run for 1 year a Markham-Stouffville Hospital. The primary outcome is the participants' self-management and activation which will be measured using The Partners in Health (PIH) scale, a validated scale measuring the current status of self-management, with items on knowledge of the condition and skills to monitor and respond to symptoms.


Options:
A: The number of ED presentations (1 year after randomization.)
B: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
C: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission. (3 years)
D: Self-management and Activation (6 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of Chronic Obstructive Pulmonary Disease
Brief Summary: This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.

It is anticipated that there will be 123 participants enrolled in this study across two experimental arms and one control arm. Participants will be in the study for 6 months and the study will run for 1 year a Markham-Stouffville Hospital. The primary outcome is the participants' self-management and activation which will be measured using The Partners in Health (PIH) scale, a validated scale measuring the current status of self-management, with items on knowledge of the condition and skills to monitor and respond to symptoms.


Options:
A: Measure of physical activity (Change from Baseline to Week 12)
B: 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)
C: Change in physical activity (Baseline and 12 months follow-up)
D: Self-management and Activation (6 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation of Postural Abnormalities in Parkinson's Disease: a Single-blind, Randomised Controlled Trial
Brief Summary: Postural abnormalities (PA) are drug refractory complications in patients with Parkinson's disease (PD) leading to pain, imbalance, gait disorders and fall-related injuries. It ultimately affects the quality of life and the hospitalisation risk. the literature on treatment outcomes is scant. Rehabilitation is the cornerstone in the management of PD patients, especially for drug-refractory complications. However, the current efforts are only partially able to resolve PA in PD. Despite differences in methodologies, the few rehabilitative studies support the benefits of trunk rehabilitation in PD with PA. Priorities for future research include well-design rehabilitation studies on a large population. The early detection and early rehabilitation of PA might avoid fixed irreversible deformities and reduce the complications that can accompany them. It ultimately might improve the quality of life, reduce the risk of fall-related injuries and hospitalisation rate. A single-blind single-blind Randomised Controlled Trial (RCT) will evaluate the effects of trunk rehabilitation on PA severity, function and disability in outpatients with Parkinson Disease and postural abnormalities.


Options:
A: Unified Parkinson's Disease Rating Scale (UPDRS) Part III (30 minutes post-dose at week 12)
B: Changes in the degrees of trunk deviation in the sagittal and coronal plane. (Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up)
C: Modified MACTAR scale (6 months)
D: Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12 (Baseline to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis：A Prospective Randomized,Controlled Trial
Brief Summary: Isometric exercise has been shown to increase the diameter and the blood flow rate of forearm veins.At present, more studies focus on the perioperative period to promote the maturation of arteriovenous fistula(AVF), while there are few reports on functional maintenance measures for the patients with maintenance hemodialysis.This study aims to explore the effect of dumbbell exercise on AVF，and evaluate whether patients can carry a 6-pound item with the fistula limb in a reasonable way.


Options:
A: Brachial artery flow-mediated dilatation (6 weeks)
B: Hemodynamics in the fistula artery and vein, pre and post AV fistula formation (22 weeks)
C: Changes in blood flow of AVF draining vein (from Baseline to 3 months)
D: Increasing the diameter of the cephalic vein (8 weeks of training for each patient)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange
Brief Summary: For performing transnasal humidified rapid insufflation ventilatory exchange (THRIVE), jaw-thrust maneuver have to maintain to make sure the airway open and the CO2 clearance during apnoea. The objective of present study is to prove that nasopharyngeal airway facilitate THRIVE and no need jaw-thrust maneuver and maintain the similar PO2 and PCO2 during apnoea.


Options:
A: Reintubation (within 72 hours after extubation or at ICU discharge)
B: Lowest noninvasive oxygenation value (Within 3 hours, beginning from the administration of the sedation or the neuromuscular blocker till the placement of the endotracheal tube); First pass success rate (With in 3 hours of the start of procedure for placement of endotracheal tube)
C: The partial pressure of carbon dioxide (pCO2) (From start to end of THRIVE(20 minutes)); The partial pressure of oxygen(PO2) (From start to end of THRIVE(20 minutes))
D: Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. (1 hour); Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death). (1 hour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting
Brief Summary: This is an open-label, multicenter, Phase 2 study to determine the safety, PK, and efficacy of lisocabtagene maraleucel (JCAR017) in subjects who have relapsed from, or are refractory to, two lines of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) in the outpatient setting. Subjects will receive treatment with JCAR017 and will be followed for up to 2 years.


Options:
A: Percentage of Participants With Cytokine Release Syndrome (CRS) Adverse Events Grade ≥ 3 (From first dose to 90 days following first dose (up to approximately 90 days)); Percentage of Participants With Neurotoxicity (NT) Adverse Events Grade ≥ 3 (From first dose to 90 days following first dose (up to approximately 90 days)); Percentage of Participants With Infection Adverse Events Grade ≥ 3 (From first dose to 90 days following first dose (up to approximately 90 days)); Percentage of Participants With Grade ≥ 3 Prolonged Cytopenia at Day 29. (At Day 29 after first treatment)
B: Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators (First infusion date up to maximum duration of 32.7 months)
C: Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment. (Study treatment until Week 24)
D: Event-free survival (EFS) (Approximately 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect Of Erector Spinae Plane Block On Postoperative Pain Management In Lumbar Disc Hernia Repair Operation
Brief Summary: Pain management after lomber disc hernia repair surgery is a challenging issue for anesthetists. Erector Spinae plane block is a novel analgesic technique which could be used for this purpose. Primary aim of this double blinded randomized controlled study is to compare the analgesic efficacy of this new block technique with control group in this group of patients.


Options:
A: QoR 15 score (24 hours post operatively)
B: the patient centred QoR-15 score among ESB and SAP block patients; (1 year)
C: Morphine consumption (postoperative first 24 hour)
D: Visual analogue score (24 hours); Total morphine consumption (24 hours); First time to receive morphine (24 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect Of Erector Spinae Plane Block On Postoperative Pain Management In Lumbar Disc Hernia Repair Operation
Brief Summary: Pain management after lomber disc hernia repair surgery is a challenging issue for anesthetists. Erector Spinae plane block is a novel analgesic technique which could be used for this purpose. Primary aim of this double blinded randomized controlled study is to compare the analgesic efficacy of this new block technique with control group in this group of patients.


Options:
A: Visual analogue score (24 hours); Total morphine consumption (24 hours); First time to receive morphine (24 hours)
B: Pain scores (1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery)
C: The incidence of chronic post surgical pain (CPSP)12 months after surgery (12 months)
D: Morphine consumption (postoperative first 24 hour)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrasound-guided Peripheral IV vs. Standard Technique in Difficult Vascular Access Patients by ICU Nurses
Brief Summary: This is a randomized controlled single-center study that will be conducted in the intensive care unit. The main objective of this study is to assess the success rate of ultrasound-guided peripheral intravenous cannulation in ICU patients with difficult intravenous access compared with traditional landmark technique.


Options:
A: Overall success rate of IV placement (Up to 30 minutes)
B: Device Failures Within 72 Hours (72 hours after device placement)
C: Length of canalization (Four weeks); Number of punctures (Four weeks); Phlebitis (Four weeks)
D: Patient's experience of pain during the procedure (up to 5 minutes.); Patient's experience with the method used to obtain venous access (1/2) (up to 5 minutes.); Patient's experience with the method used to obtain venous access (2/2) (up to 10 minutes.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrasound-guided Peripheral IV vs. Standard Technique in Difficult Vascular Access Patients by ICU Nurses
Brief Summary: This is a randomized controlled single-center study that will be conducted in the intensive care unit. The main objective of this study is to assess the success rate of ultrasound-guided peripheral intravenous cannulation in ICU patients with difficult intravenous access compared with traditional landmark technique.


Options:
A: Reducing the use of CVC and PVC (through study completion, an average of 7 month)
B: length of use of the catheter measured in number of days (seven days)
C: Device Failures Within 72 Hours (72 hours after device placement)
D: Overall success rate of IV placement (Up to 30 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Violence Against Children in Schools: Protocol for a Cluster Randomised Controlled Trial of the EmpaTeach Behavioural Intervention in Nyarugusu Refugee Camp
Brief Summary: To date, no interventions to prevent violence in refugee camp schools have ever been rigorously evaluated. The primary objective of this project is to test the effectiveness of the Empateach intervention to prevent physical violence from teachers to students in Nyarugusu Refugee Camp, Tanzania. Secondary objectives are to assess the impact of the Empateach intervention on student's depressive symptoms, experience of emotional violence and educational test scores. A two arm cluster RCT with parallel assignment will be conducted.


Options:
A: physical violence (Assessed at 10-week follow-up)
B: Change in COVID-19 knowledge (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in COVID-19 protective behaviors (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in depressive symptoms (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in anxiety symptoms (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey)
C: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
D: Teachers' knowledge (At the end of 3 days workshop)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis
Brief Summary: The purpose of this study is to assess the efficacy and safety of twice daily ruxolitinib cream in adolescents and adults with Atopic Dermatitis (AD).


Options:
A: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 (Baseline to Week 8)
B: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 (Baseline (pre-dose on Day 1) and Week 4)
C: Occurrence of systemic or cutaneous malignancy (10 years)
D: Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period (From randomization to first flare or last ISGA assessment (up to 52 weeks)); Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Crisaborole 2% BID: From start of study intervention in OL period up to 8 weeks ; Vehicle QD and crisaborole 2% QD: From start of study intervention in DB period up to 28 days after last dose of study intervention (maximum of 56 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2 (TRuE AD2) - A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis
Brief Summary: The purpose of this study is to assess the efficacy of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).


Options:
A: VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 (Baseline to Week 8)
B: Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID (Baseline and Week 4)
C: Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29 (Day 29); Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36); Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29 (Baseline, Day 29); Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29 (Baseline, Day 29)
D: The incidence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of diagnosed co-morbidities in people with and without atopic dermatitis (Prevelence reported annually by year from 2008-2018); Annual rates of service utilisation (number of primary and secondary care visits) in people with atopic dermatitis (Measures will be reported annually by year from 2008-2018); Annual prescription rates for atopic dermatitis related treatments (Measures will be reported annually by year from 2008-2018)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Web-based Self-management Intervention to Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD, in Primary Care: A Protocol for a Randomized Controlled Clinical Trial
Brief Summary: This study evaluates the effects of the COPD Web (KOLwebben), an interactive web-based tool directed towards people with chronic obstructive pulmonary disease (COPD). The COPD Web include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. This randomized clinical trial aims to generate evidence on the effect and usability of the COPD Web in a properly powered cohort of patients in primary care context.


Options:
A: Change in physical activity (Baseline and 12 months follow-up)
B: thoracoabdominal motion (2 years)
C: Change in level of objectively measured physical activity (7 Days at baseline, 7 days at 3- and 12- months after baseline)
D: "Quality of care process" (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Web-based Self-management Intervention to Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD, in Primary Care: A Protocol for a Randomized Controlled Clinical Trial
Brief Summary: This study evaluates the effects of the COPD Web (KOLwebben), an interactive web-based tool directed towards people with chronic obstructive pulmonary disease (COPD). The COPD Web include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. This randomized clinical trial aims to generate evidence on the effect and usability of the COPD Web in a properly powered cohort of patients in primary care context.


Options:
A: Six Minute Walk Distance (6 weeks); COPD Assesment Tool (CAT) (6 weeks)
B: Re-hospitalizations (During the 30days after discharge)
C: Daily number of steps (changes from baseline to 3 months)
D: Change in level of objectively measured physical activity (7 Days at baseline, 7 days at 3- and 12- months after baseline)

Answer: D