TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of the Prescription of 10,000 Steps a Day Using a Pedometer Via Mobile APP, Through a Goal Setting System, in the Body Composition of Overweight Adults: a 6-Month Randomized Weight Loss and mHealth Trial.
Brief Summary: This study aimed the effect of the Accupedo pedometer smartphone app intervention, with goal setting of walking prescription of 10,000 steps per day, in overweight adults.


Options:
A: Weight Change from Baseline to 24 weeks (0 and 24 weeks)
B: Changes from baseline BMI (At baseline (0 years) and followed for 2 years); Changes from baseline Fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Free-fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Muscular Mass (At baseline (0 years) and followed for 2 years); Changes from baseline Corporal Water (At baseline (0 years) and followed for 2 years); Adherence to dietary pattern will be also measured through personal interview (At baseline (0 years) and followed for 2 years); Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire) (At baseline (0 years) and followed for 2 years); Changes from baseline in the number of steps per day (At baseline (0 years) and followed for 2 years)
C: Change in weight status (24 months)
D: Percent Change in Body Weight From Baseline to 12 Weeks (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study
Brief Summary: This randomized controlled trial (RCT) will evaluate if PRO-based follow-up is at least as effective as usual outpatient follow-up in managing decline in renal function and maintaining patients' quality of life. Furthermore, we intend to characterize the target patient group that is suitable for PRO-based follow up in a group of patients suffering from renal insufficiency.


Options:
A: Number of sick-leave days. (12 months after inclusion); Number of periods of sick-leave, full-time or part-time. (12 months after inclusion)
B: Risky drinking (6, 12, 18, 24 months)
C: Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up (baseline and 3 month follow up)
D: Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months (Measured at baseline, 6, 12 and 18 months after randomisation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improvement of Medicine Adherence and the Following Positive Effects on Transplants in Patients After Organ Transplantation With Pilloxa's Electronic Pillbox
Brief Summary: Poor adherence to medication among patients with chronic diseases is a major problem. A patient group where the adherence to prescribed medications is extremely important are organ transplanted patients. It is well established that lack of adherence to immunosuppressive medication drastically increases the risk of rejection reactions, graft loss and deaths.

Pilloxa is a device meant to help users manage medication and support adherence to medication. This study evaluates if Pilloxa improves adherence to treatment for transplanted patient compared with conventional management. Patients who have received a transplanted kidney or liver will be studied.

Pilloxa is a system comprising of: a box with 14 separate containers to temporarily store tablets/capsules in and that can be open by 14 independent lids, a smartphone application and cloud based servers. The pillbox will at given times detect if pills are present in the different compartments and can connect, send and receive information to/from mobile application and the cloud.


Options:
A: 12-week immunosuppression medication adherence (12 weeks)
B: Adherence to medication (During 6 months)
C: adherence rate (up to 6 months)
D: Adherence as measured by unannounced telephone pill count (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS)
Brief Summary: Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe plaque psoriasis.


Options:
A: Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16 (Week 16)
B: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 (Week 24)
C: Psoriasis Area and Severity Index (PASI) (Baseline to Week 16)
D: The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16 (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH): A Feasibility Trial
Brief Summary: Non-suicidal self-injury (NSSI) is when somebody engages in self-harm, such as cutting, without meaning to end his or her life. A large number of people engage in NSSI for lots of reasons, for example to cope with emotions. However, currently there are large waiting lists to access psychological therapy through the NHS. Therefore, it is important to research brief therapies so that individuals who engage in NSSI can receive treatment quicker. One potentially helpful therapy suggested is Cognitive Analytic Therapy (CAT), which focuses on patterns in relationships. NSSI can be understood as a way in which people relate to themselves, which suggests that CAT would fit well in terms of understanding and working with these difficulties.

This study aims to evaluate a brief two-session CAT therapy for people who engage in NSSI. The project aims to evaluate the feasibility and acceptability of the therapy, using interviews and questionnaires. This means looking at whether participants stick with the therapy, and how they find taking part in the therapy.

All participants will meet with a researcher for an initial session to complete baseline questionnaires about their current difficulties, thoughts and feelings. Participants will then be randomly allocated to a condition: either the therapy condition or the treatment-as-usual (TAU) condition. Participants in the therapy condition will receive two therapy sessions, whilst participants in the TAU condition will not receive any therapy sessions. All participants will attend a final session to complete more questionnaires. Participants will be asked to complete online surveys weekly. Some participants will be invited to take part in interviews about their experience of the therapy. All participants will receive a shopping voucher as compensation for their time. Using the data collected from this study, future work can be done to provide better treatment for people who engage in NSSI.


Options:
A: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)
B: drinking - measured using the TLFB (12 weeks); craving - measured using the OCDS (12 weeks); aggression - measured using the STAE (12 weeks)
C: Impact of omega-3 HUFA supplementation on suicidal behaviors and thinking among adults. (6 months)
D: Acceptability- attendance rates (Five weeks); Safety- adverse experiences (Five weeks); Feasibility - completion rate of assessments (Five weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH): A Feasibility Trial
Brief Summary: Non-suicidal self-injury (NSSI) is when somebody engages in self-harm, such as cutting, without meaning to end his or her life. A large number of people engage in NSSI for lots of reasons, for example to cope with emotions. However, currently there are large waiting lists to access psychological therapy through the NHS. Therefore, it is important to research brief therapies so that individuals who engage in NSSI can receive treatment quicker. One potentially helpful therapy suggested is Cognitive Analytic Therapy (CAT), which focuses on patterns in relationships. NSSI can be understood as a way in which people relate to themselves, which suggests that CAT would fit well in terms of understanding and working with these difficulties.

This study aims to evaluate a brief two-session CAT therapy for people who engage in NSSI. The project aims to evaluate the feasibility and acceptability of the therapy, using interviews and questionnaires. This means looking at whether participants stick with the therapy, and how they find taking part in the therapy.

All participants will meet with a researcher for an initial session to complete baseline questionnaires about their current difficulties, thoughts and feelings. Participants will then be randomly allocated to a condition: either the therapy condition or the treatment-as-usual (TAU) condition. Participants in the therapy condition will receive two therapy sessions, whilst participants in the TAU condition will not receive any therapy sessions. All participants will attend a final session to complete more questionnaires. Participants will be asked to complete online surveys weekly. Some participants will be invited to take part in interviews about their experience of the therapy. All participants will receive a shopping voucher as compensation for their time. Using the data collected from this study, future work can be done to provide better treatment for people who engage in NSSI.


Options:
A: Acceptability- attendance rates (Five weeks); Safety- adverse experiences (Five weeks); Feasibility - completion rate of assessments (Five weeks)
B: Clinical changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neural changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy. (4 months)
C: Re-presentation to hospital with suicide attempt and/or suicidal ideations (7 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (14 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (30 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (90 days post intervention); Death by suicide rates (24 months post intervention)
D: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Analytic Therapy-informed Containment for Self-Harm (CATCH): A Feasibility Trial
Brief Summary: Non-suicidal self-injury (NSSI) is when somebody engages in self-harm, such as cutting, without meaning to end his or her life. A large number of people engage in NSSI for lots of reasons, for example to cope with emotions. However, currently there are large waiting lists to access psychological therapy through the NHS. Therefore, it is important to research brief therapies so that individuals who engage in NSSI can receive treatment quicker. One potentially helpful therapy suggested is Cognitive Analytic Therapy (CAT), which focuses on patterns in relationships. NSSI can be understood as a way in which people relate to themselves, which suggests that CAT would fit well in terms of understanding and working with these difficulties.

This study aims to evaluate a brief two-session CAT therapy for people who engage in NSSI. The project aims to evaluate the feasibility and acceptability of the therapy, using interviews and questionnaires. This means looking at whether participants stick with the therapy, and how they find taking part in the therapy.

All participants will meet with a researcher for an initial session to complete baseline questionnaires about their current difficulties, thoughts and feelings. Participants will then be randomly allocated to a condition: either the therapy condition or the treatment-as-usual (TAU) condition. Participants in the therapy condition will receive two therapy sessions, whilst participants in the TAU condition will not receive any therapy sessions. All participants will attend a final session to complete more questionnaires. Participants will be asked to complete online surveys weekly. Some participants will be invited to take part in interviews about their experience of the therapy. All participants will receive a shopping voucher as compensation for their time. Using the data collected from this study, future work can be done to provide better treatment for people who engage in NSSI.


Options:
A: Change in Number of Deaths by Suicide and/or Re-Presentations to Any Emergency Department (ED) in Ontario for Self-Harm - Data from the Institute for Clinical Evaluative Sciences (ICES) (Baseline; 12 Months.)
B: Acceptability- attendance rates (Five weeks); Safety- adverse experiences (Five weeks); Feasibility - completion rate of assessments (Five weeks)
C: Clinical Global Impression (CGI) (Day 0); Suicide Intent Scale (Day 0); Montgomery-Asberg depression rating scale (Day 0)
D: Changes in Beck Scale for Suicide Ideation (Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Mirror Therapy on Unilateral Neglect for Patients After Stroke
Brief Summary: This is a single-blinded randomized controlled trial to investigate the effects of mirror therapy (MT), with reference to sham mirror (a glass wall) and control (a covered mirror), in reducing unilateral neglect for patients with stroke in 2 centres.


Options:
A: Change in Hemispatial neglect scores (After 1 hour of OKS); Change in Hemispatial neglect scores (After 1 hour of OKS); Effect of OKS on vision (After 1 hour of OKS); Effect of OKS on vision (After 1 hour of OKS)
B: Spatial neglect assessment battery (Before and immediately after intervention); Family caregiver wellness (Before and immediately after intervention)
C: Change of Repeatable Battery for the Assessment of Neuropsychological Status (Up to 12 weeks)
D: Unilateral neglect (Change of baseline to 3-week and to follow-up at 6-week); Allocentric and egocentric neglect (Change of baseline to 3-week and to follow-up at 6-week); Functional performance related to unilateral neglect (Change of baseline to 3-week and to follow-up at 6-week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
Brief Summary: The investigators prepared a novel study of tranexamic acid (TXA) designed to estimate the quantity of blood loss in women undergoing elective repeat cesarean deliveries. This is the first trial to utilize a prophylactic dose of TXA prior to incision followed by a subsequent prophylactic dose at placental delivery in obstetric patients undergoing scheduled cesareans. The purpose of this study is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in women undergoing repeat cesarean sections.


Options:
A: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)
B: Pharmacokinetic (24 hours after randomisation)
C: Estimated blood loss (EBL) during cesarean delivery (during the operation)
D: Blood Volume Loss (24 hours postpartum.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylatic Effect of Preoperative Antibiotics With Mechanical Bowel Preparation Compare With Simple Mechanical Bowel Preparation Before Laparoscopic Colorectal Surgery: a Randomized Controlled Trial
Brief Summary: Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Combination of oral antibiotics and mechanical bowel preparation was reported with lower SSIs and LOS in some retrospecitve data analysis, however a prospective randmized controlled trial was absent. Herein, the current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.


Options:
A: Surgical Site Infection Rate (30 days following date of surgery)
B: Surgical site infection incidence (30 days after surgery)
C: Comprehensive Complication Index (Within 30 days from surgery)
D: anastomotic leakage and/or abscess (30 days postoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease
Brief Summary: In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease.

NOTE: All sites have been selected for this study. We are not seeking additional sites at this time.


Options:
A: Change of Dry Eye Symptoms (after 3 month compared to baseline value)
B: NIBUT (Non-Invasive Break-Up Time) (The difference between the change in NIBUT of LipiFlow group and control group between Visit 0 (screening/baseline) and Visit 2 (one month after surgery))
C: Tear Break-Up Time (1 month); Meibomian Gland Secretion Score (1 month)
D: ocular discomfort (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Stimulation System in the Treatment of Chronic Pain
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.


Options:
A: Changes in pain (6 months)
B: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)
C: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Number of Responders (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline at Week 1 in Mean Weekly Pain Scores (From baseline to Week 1); Change From Baseline at Week 2 in Mean Weekly Pain Scores (From baseline to Week 2); Change From Baseline at Week 3 in Mean Weekly Pain Scores (From baseline to Week 3); Change From Baseline at Week 4 in Mean Weekly Pain Scores (From baseline to Week 4); Change From Baseline at Week 5 in Mean Weekly Pain Scores (From baseline to Week 5); Change From Baseline at Week 6 in Mean Weekly Pain Scores (From baseline to Week 6); Change From Baseline at Week 7 in Mean Weekly Pain Scores (From baseline to Week 7); Change From Baseline at Week 8 in Mean Weekly Pain Scores (From baseline to Week 8); Change From Baseline at Week 9 in Mean Weekly Pain Scores (From baseline to Week 9); Change From Baseline at Week 10 in Mean Weekly Pain Scores (From baseline to Week 10); Change From Baseline at Week 11 in Mean Weekly Pain Scores (From baseline to Week 11); Change From Baseline at Week 12 in Mean Weekly Pain Scores (From baseline to Week 12); Change From Baseline at Week 13 in Mean Weekly Pain Scores (From baseline to Week 13)
D: Change in Multidimensional Pain Inventory (MPI)-SCI average activity score (Baseline, 9 months); Motor recovery as measured by EMG (Up to 9 months); Motor recovery as measured by dynamometry (Up to 9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Stimulation System in the Treatment of Chronic Pain
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.


Options:
A: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)
B: Visual Analog Scale (VAS) on Back Pain (12 weeks)
C: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
D: Patient's Global Impression of Change (PGIC)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Stimulation System in the Treatment of Chronic Pain
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.


Options:
A: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period
B: Changes in pain (6 months)
C: Visual Analogic Scale Low Back pain (Month 6)
D: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM： A Randomized Controlled Trial
Brief Summary: This is a randomized controlled trial about an app-based case management intervention. The intervention is a comprehensive case management approach consisting of the following aspects: articles delivery, online communication with case managers, supportive service information and hospital visits reminders. The aim of this study is to evaluate the efficacy of the intervention among HIV-positive men who have sex with men compared to standard-of-care service.


Options:
A: Child Developmental Outcomes (Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey.); Child Developmental Outcomes (Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions); Parenting Practices (HOME Observation for Measurement of the Environment - HOME) (Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3).); Parenting Practices (HOME Observation for Measurement of the Environment - HOME) (Month 35-37 Follow-up Survey (Arms 3, A and B).)
B: self-reported ART medication adherence (month 6 after enrolment); CD4 count (month 6 after enrolment)
C: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
D: Zarit Burden Inventory-4 (3 months)

Answer: B