TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of Intravenous Transplantation of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS
Brief Summary: ALS is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment that has been found to improve survival but only to a modest extent. It lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. It also extends the time before a person needs ventilation support.Stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.


Options:
A: Safety evaluation and tolerability of a single treatment administration in an escalating-dose of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (At baseline and up to 6 month following treatment administration)
B: Safety evaluation and tolerability of a single treatment administration of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months); Safety evaluation and tolerability of single intrathecal injection (IT) into the cerebrospinal fluid (CSF) of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) (6 months)
C: Fever (48hours); Unconsciousness (48hours); vomiting (48hours)
D: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks (baseline and 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigating the Effectiveness of Exercise Coaching on the Physical Activity Behavior of Physically Inactive Employees in a Company in Flanders: a Randomized Control Trial.
Brief Summary: The primary aim of this study is to investigate if and how a physical activity counselor can offer an added value in exercise promotion in physically inactive employees. We will explore if the physical activity counselor in the workplace setting can motivate sedentary employees to engage into systematic participation in sports and/or exercise by means of a short term coaching of 12 weeks. We aim to include 300 employees in the physical activity coaching process.


Options:
A: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)
B: duration of prolonged sitting (5 days)
C: Acceptability and feasibility (3 weeks)
D: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigating the Effectiveness of Exercise Coaching on the Physical Activity Behavior of Physically Inactive Employees in a Company in Flanders: a Randomized Control Trial.
Brief Summary: The primary aim of this study is to investigate if and how a physical activity counselor can offer an added value in exercise promotion in physically inactive employees. We will explore if the physical activity counselor in the workplace setting can motivate sedentary employees to engage into systematic participation in sports and/or exercise by means of a short term coaching of 12 weeks. We aim to include 300 employees in the physical activity coaching process.


Options:
A: Change in objective measure of degree of physical activity (baseline, 12 weeks, 6 months)
B: Change in sedentary behavior during the workday (Baseline - week 8)
C: change in physical activity (4 months)
D: Daily sitting time (baseline and 23 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Build Better Bones With Exercise: A Pilot Randomized Controlled Trial of Exercise in Women With Osteoporotic Vertebral Fracture
Brief Summary: The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.


Options:
A: Back pain (Baseline and six months)
B: Feasibility of Recruitment and Retention (Monthly records up to 12 months.); Adherence (Monthly records over 12 months)
C: The primary outcome measure is actual LBP, as measured with an "11 point box scale". (10 weeks and 12 months)
D: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (Median 2.7 years/Average 2.6 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga Dosing Study for Chronic Low Back Pain in a Predominantly Low-Income Minority Population
Brief Summary: A 12-week randomized controlled trial (RCT) for chronic low back pain in predominantly minority populations comparing yoga classes once/week vs. twice/week. Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.


Options:
A: Change from Self-reported lumbar pain intensity at 3 weeks. (At the start of the study, before the fifth treatment session (third week)); Change from Self-reported lumbar pain intensity at 5 weeks. (After the last treatment session (fifth week).); Change from Disability at 3 weeks. (At the start of the study, before the fifth treatment session (third week)); Change from Disability at 5 weeks. (After the last treatment session (fifth week).)
B: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)
C: Pain (12 months); Disability (12 months)
D: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga Dosing Study for Chronic Low Back Pain in a Predominantly Low-Income Minority Population
Brief Summary: A 12-week randomized controlled trial (RCT) for chronic low back pain in predominantly minority populations comparing yoga classes once/week vs. twice/week. Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.


Options:
A: Back-related function (6 months); Pain (6 months)
B: N/A
C: Change from Baseline in Average Pain intensity in previous week (12 wks); Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability (12 wks)
D: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga Dosing Study for Chronic Low Back Pain in a Predominantly Low-Income Minority Population
Brief Summary: A 12-week randomized controlled trial (RCT) for chronic low back pain in predominantly minority populations comparing yoga classes once/week vs. twice/week. Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.


Options:
A: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)
B: Client Satisfaction Questionnaire (3 months); Credibility Expectancy Questionnaire (CEQ) (1 month); Participant adherence (3 months); Participant homework adherence (3 months); Instructor manual fidelity checklist (3 months); Systematic Assessment of Treatment-Emergent Events - General Inquiry (3 months)
C: Number of Days on Sick Leave (12 MONTHS)
D: Back-related function (6 months); Pain (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
Brief Summary: CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.


Options:
A: Viral load (6 months post-randomization)
B: Adherence to PrEP (Baseline to Week 48)
C: Acceptability of at least one method of effective contraception (4 months)
D: Knowledge of Reproductive Health True/False Quiz of 20 questions (5-6 months after baseline and then again 14-16 months after baseline); Sexual behavior (14-16 months after baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
Brief Summary: CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.


Options:
A: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
B: Uptake of the timed appointment provided by the screening service (Usually within a month (Individual timed appointment is provided by the screening service))
C: Adherence to PrEP (Baseline to Week 48)
D: ART Adherence at 20 Weeks as Determined by VAS, Viral Load (20week [End of study]); ART Adherence at 20 Weeks as Determined by Pill Counts, ACTG Adherence Questionnaire, and VAS Scores (20week [End of study]); ART Adherence at 20 Weeks as Determined by Viral Load Count (20 week [End of study]); ART Adherence at 20 Weeks as Determined by Log of Viral Load Count (20week [End of study])

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
Brief Summary: CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.


Options:
A: Adherence to PrEP (Baseline to Week 48)
B: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
C: Intention to treat analysis (13 months)
D: Proportion of men failing to return for a post-operative clinic visit at 7 days. (7 days); Proportion of men who report resumption of sexual activity before 42 days post-circumcision. (42 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
Brief Summary: CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.


Options:
A: Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not. (Up to 5 months)
B: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)
C: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
D: Adherence to PrEP (Baseline to Week 48)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Protecting Pregnant Women From Infectious Diseases: a Cluster Randomized Evaluation of the Comprehensive "P3" Intervention Package Within Obstetric Practices in Georgia
Brief Summary: The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis vaccine.


Options:
A: Improved immunization coverage (At the completion of all recruitment and follow ups which will take an average time of 1 year)
B: Receipt of influenza vaccine during pregnancy (Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.)
C: 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds (Baseline, month 6)
D: Parental Vaccine Hesitancy Measure (Change from Baseline in Parental Hesitancy at 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Continuous renal replacement therapy (CRRT) has been considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care unit (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU patients often make it equivocal to use anticoagulation. This is a prospective randomized controlled study to show the difference in filter life span and adverse event between HF1000 (nafamostat mesilate) group and M100 (heparin-free) group.


Options:
A: Interleukin 6 (IL-6) plasmatic concentration (24 hours after the initiation of CVVH); Endotoxin plasmatic mass concentration (24 hours after the initiation of CVVH)
B: N/A
C: Time of insertion without complication
D: mortality (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Continuous renal replacement therapy (CRRT) has been considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care unit (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU patients often make it equivocal to use anticoagulation. This is a prospective randomized controlled study to show the difference in filter life span and adverse event between HF1000 (nafamostat mesilate) group and M100 (heparin-free) group.


Options:
A: Filter Life (72 hours)
B: mortality (2 years)
C: Middle molecular weight molecules clearances (18 months)
D: Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason) (up to 28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Continuous renal replacement therapy (CRRT) has been considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care unit (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU patients often make it equivocal to use anticoagulation. This is a prospective randomized controlled study to show the difference in filter life span and adverse event between HF1000 (nafamostat mesilate) group and M100 (heparin-free) group.


Options:
A: CRRT-filter life span in hours (during continuous renal replacement therapy up to 1 year); Overall survival in a 90day follow-up period (90 days)
B: Number of filters used per hour (24 months)
C: mortality (2 years)
D: the time of 1st membrane exchange (the time of 'filter is clotted')

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: TEA (Together for Empowerment Activities)for Families and Children: A Randomized Intervention Trial
Brief Summary: The impact of HIV/AIDS is negatively influencing the affected families and their next generation. HIV is radiating through the extended families, shifting the life patterns not only for the parents living with HIV/AIDS (PLH), but also for their children, partners, and other family members. To help PLHs and their family members, the TEA intervention has been developed, refined and piloted in the previous study. The goal of this study is to implement the TEA intervention in a full scale to determine its efficacy and the potential for enhancing HIV policy and programs that support HIV-affected families to cope with the challenges in China in responding to the global HIV epidemic.


Options:
A: children's behavior problems and health (Change from baseline to 6-, 12-, 18-, and 24 month follow up)
B: Unprotected vaginal and anal sex (Baseline); Unprotected vaginal and anal sex (6 month follow-up); Unprotected vaginal and anal sex (12-month follow-up)
C: Change from baseline post traumatic stress symptoms at 6 months (baseline and 6 month follow up); Change from baseline depression symptoms at 6 months (baseline and 6 month follow up); Change from baseline hope at 6 months (baseline and 6 month follow up)
D: The primary outcome is the number of outcomes out of 15 outcomes significantly favoring the intervention over the control (Harwood, Weiss & Comulada, 2017) (Baseline to 18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg
Brief Summary: The purpose of this study is to assess the control of COPD using a symptom and exacerbation risk based treatment strategy based on GOLD 2011. This study is conducted in Japanese subjects with COPD and assess whether the GOLD 2011 strategy is effective in medical practice in Japan.


Options:
A: Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint (Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant))
B: AUC (0-4hrs, sGAW after morning dose of medication at day 14)
C: Forced Expiratory Volume in 1 Second (FEV1) Pre-dose (Baseline to 12 weeks)
D: Percentage of Participants Who Were Able to Remain on the Randomized Treatment (24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Training With Whole Body Vibration Device (Galileo) on Quality of Life (QoL), Exercise Capacity, as Well as on the Effects of Muscle Power and Muscle Function in Patients With Pulmonal Arterial Hypertension (PAH). (GALILEO PAH)
Brief Summary: Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.


Options:
A: Pre and post exercise training CPET (10 wks); Accelerometry-based activity (10 wks); 6 minute walk distance (10 wks); Quality of life and functional measures (10 wks)
B: Functional exercise capacity (Oxygen consumption measurement during test) (6 weeks)
C: Survival (5 years)
D: changes in 6-Minute Walk Distance (6MWD) (baseline and week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities: the SUCCEED Trial
Brief Summary: The purpose of this study is to test a newly-developed outpatient clinic and community-based care intervention called SUCCEED (Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities) for improving control of stroke risk factors among stroke patients in the Los Angeles County "safety net", and to measure the costs of running such an intervention, relative to usual care.


Options:
A: Change in PTSD Symptom Severity (PDS) (Baseline, 6 months)
B: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)
C: Systolic Blood Pressure (12 months)
D: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities: the SUCCEED Trial
Brief Summary: The purpose of this study is to test a newly-developed outpatient clinic and community-based care intervention called SUCCEED (Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities) for improving control of stroke risk factors among stroke patients in the Los Angeles County "safety net", and to measure the costs of running such an intervention, relative to usual care.


Options:
A: Systolic Blood Pressure (12 months)
B: the score-change of the Functional Independence Measure (FIM) assessment for daily living function (baseline, 2-week, 4-week and three months after stroke)
C: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)
D: VO2-peak, strength, walking, activities of daily living (baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.)

Answer: A