TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Free Sugar Replacement with Non-nutritive Sweeteners on Metabolic Health of High Sugar Sweetened Beverages Consumers: Potential Role of the Gut Microbiome
Brief Summary: Increasing evidence suggest that artificial sweeteners such as saccharin, aspartame and sucralose may not be as metabolically safe as they first appeared, and it has been proposed that their consumption may be linked to important disturbances in the gut microbiome. Some in vitro and in vivo studies suggest that the recently approved sugar substitute Stevia (eg. steviol glycosides) can also influence intestinal homeostasis. However, it is not clear whether this natural non-nutritive sweetener (NNS) could also cause metabolic and microbiome disturbances as proposed for their synthetic counterparts. In fact, steviol glycosides may even have a beneficial impact on glucose homeostasis and lipid metabolism possibly through a positive action on intestinal health and gut microbiome, but this has yet to be experimentally tested in a rigorous study.

The main objective of this project is to evaluate whether steviol glycosides sweetened beverages (SGSB) or aspartame/acesulfame K sweetened beverages (AASB) exert beneficial, neutral or detrimental effects on metabolic health of regular consumers of sugar-sweetened beverages (SSBs), and whether modulation of the gut microbiome is involved in the resulting impact of these NNSs on metabolic health.

As chronic overconsumption of SSBs is clearly associated with an increased cardiometabolic risk, this study will be the first to determine the metabolic impact of replacing SSBs by potentially "healthier alternatives" such as the increasingly popular stevia-based soft drinks and aspartame-based soft drinks. The investigators will further investigate whether these NNS can cause pernicious effects on intestinal health and the gut microbiome. It is a crucial concern since the importance of this unsuspected key "organ" has been ignored for too long and its important implication in many chronic societal diseases has just been discovered.

Results of this study could have a direct influence on health, nutrition and even agricultural policies as well as dietary guidelines around the world. This project is also critically important as an increasing amount of health professionals such as physicians, nurses and registered dietitians seek to provide evidenced-based guidance to individuals looking for healthier alternatives to SSBs including stevia-based or aspartame-based soft drinks.


Options:
A: Changes in metabolic syndrome parameters including insulin/glucose homeostasis and lipid/lipoprotein metabolism in sugar-sweetened beverages (SSB) consumers following regular, diet or stevia-sweetened beverages intakes for 10 weeks. (18-24 months)
B: Glucose in mg/dl (12 weeks); Triglycerides in mg/dl (12 weeks); Insulin (12 weeks); Cholesterol in mg/dl (12 weeks)
C: Change in body weight from baseline (4 weeks)
D: Feasibility measured by recruitment and retention rates (1 year in a 9 year study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing the Delivery of HIV Post-exposure Prophylaxis: A Randomized Controlled Trial of Text Messaging Support and Physician to Nurse Task-shifting
Brief Summary: Despite decades of traditional prevention efforts based on behavior change and condom use, Ontario has seen over 700 new HIV infections annually over the past 10 years. Post-exposure prophylaxis (PEP) is one such approach, in which uninfected persons use 28 days of antiretroviral medications (ARVs) shortly after an HIV exposure to minimize the risk of acquiring HIV. PEP is highly efficacious, is considered a standard of care intervention based on medical and ethical grounds, and is supported by treatment guidelines. Yet several implementation challenges have limited its clinical and public health impact in Ontario, where no formal PEP policy exists. Our proposal seeks to optimize two aspects of delivering PEP for sexual exposures (nPEP). Results will inform the development of a standardized approach to nPEP both province-wide and elsewhere.

Thus study has pragmatic, multicenter randomized controlled trial using a 2x2 factorial design to determine whether the proportion of nPEP patients that successfully complete follow-up:

1. is higher among those receiving mobile phone-based text messaging support than among those receiving standard care; and
2. is non-inferior among those receiving care from a sexual health clinic nurse compared to those receiving hospital-based physician care.

The prospective, randomized, non-blinded, 2x2 factorial trial that will enroll 318 study participants in Toronto. In Intervention A, we will randomize half of study participants to a text messaging support service ('WelTel'), in which a trained, community-based counselor provides standardized weekly 'check-in' messages during their 12-week course of PEP follow-up. The other half will receive standard care, which does not include any form of active outreach or reminders outside of scheduled appointments. In Intervention B, we will randomize half of participants to receive nurse-led care for PEP follow-up at a local sexual health clinic; the other half will receive standard care by a hospital-based ID physician. The specific activities for each follow-up visit will be clearly defined in a medical directive. In keeping with Ontario legislation on medical directives, nurses will review cases with their authorizing physician or nurse practitioner on a routine basis.


Options:
A: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)
B: Use of effective contraception (4 months); Acceptability of at least one method of effective contraception (4 months)
C: Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure (12 weeks)
D: Proportion of women who received a Pap smear within 6 months from the date when the study randomization began. (6 months after randomization of study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing the Delivery of HIV Post-exposure Prophylaxis: A Randomized Controlled Trial of Text Messaging Support and Physician to Nurse Task-shifting
Brief Summary: Despite decades of traditional prevention efforts based on behavior change and condom use, Ontario has seen over 700 new HIV infections annually over the past 10 years. Post-exposure prophylaxis (PEP) is one such approach, in which uninfected persons use 28 days of antiretroviral medications (ARVs) shortly after an HIV exposure to minimize the risk of acquiring HIV. PEP is highly efficacious, is considered a standard of care intervention based on medical and ethical grounds, and is supported by treatment guidelines. Yet several implementation challenges have limited its clinical and public health impact in Ontario, where no formal PEP policy exists. Our proposal seeks to optimize two aspects of delivering PEP for sexual exposures (nPEP). Results will inform the development of a standardized approach to nPEP both province-wide and elsewhere.

Thus study has pragmatic, multicenter randomized controlled trial using a 2x2 factorial design to determine whether the proportion of nPEP patients that successfully complete follow-up:

1. is higher among those receiving mobile phone-based text messaging support than among those receiving standard care; and
2. is non-inferior among those receiving care from a sexual health clinic nurse compared to those receiving hospital-based physician care.

The prospective, randomized, non-blinded, 2x2 factorial trial that will enroll 318 study participants in Toronto. In Intervention A, we will randomize half of study participants to a text messaging support service ('WelTel'), in which a trained, community-based counselor provides standardized weekly 'check-in' messages during their 12-week course of PEP follow-up. The other half will receive standard care, which does not include any form of active outreach or reminders outside of scheduled appointments. In Intervention B, we will randomize half of participants to receive nurse-led care for PEP follow-up at a local sexual health clinic; the other half will receive standard care by a hospital-based ID physician. The specific activities for each follow-up visit will be clearly defined in a medical directive. In keeping with Ontario legislation on medical directives, nurses will review cases with their authorizing physician or nurse practitioner on a routine basis.


Options:
A: Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure (12 weeks)
B: Completion of vaccine primary series (12 months of age)
C: Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study (4-months post-encouragement)
D: Immunization coverage (12 months); Timeliness of receipt of scheduled immunization (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Personalised Physical Training Associated With Usual Management Versus Usual Management Alone on Fatigue and Recovery After Minor Stroke: Randomised Controlled Trial
Brief Summary: After a minor stroke, patients frequently report complaints such as fatigue and difficulty with certain everyday motor tasks, leading to a marked deterioration in their quality of life. The aim of this study is to show that the implementation of a personalised physical activity programme, starting 1 month after the hospitalisation for minor stroke, significantly decreases the frequency of fatigue in these patients, in comparison with usual management "in real life"..


Options:
A: Maximum torque around the knee joint; gait velocity
B: Fatigue relief (assessed by the Fatigue Severity Scale) (4 months after the stroke)
C: Box and Block Test; Data Collected = Number of Blocks Moved (Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)); Fugl-Meyer Upper Extremity Motor Test (Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)); Fractionated Reaction Time (Baseline/pretest; posttest given between days 17-22 (posttest days 3-8))
D: bimanual coordination (up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
Brief Summary: The study is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy and failed.


Options:
A: Overall Survival (OS) (From date of randomizationrandomization to date of death from any cause assessed up to 40 months); Progression-free survival (From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months)
B: Overall Response (Up to 3 years); Time to Treatment Failure (Up to 3 years); Overall Survival (Up to 5 years)
C: Progression-Free Survival (PFS) Comparison (2 Years)
D: Progression-free survival (PFS) (approximately 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
Brief Summary: The study is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy and failed.


Options:
A: Overall survival (After follow-up is complete (year 3-4 of the trial))
B: Progression-free survival (PFS) (approximately 2 years)
C: Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only (From initial dose through final study visit up to 44 months); Bone Scan Response (BSR) - NRE, CRPC (From initial dose through final study visit up to 15 months); Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only (From initial dose through final study visit up to 44 months)
D: Time to Repeat Paracentesis (TRP) (From Day 1 up to 6 months from randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.
Brief Summary: Objectives:

This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life.

Hypothesis:

GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.


Options:
A: modified rankin score（mRS） (post-procedural 90 days)
B: Number of Participants With a Score of 5 or 6 on the Modified Rankin Scale (mRS) (90 days)
C: Modified Angiographic collateral circulation assessed by blinded core lab (Immediately prior to revascularization)
D: Growth of DWI lesion (48-72 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Identification and Treatment of Back Pain in Elderly Women With Osteoporosis
Brief Summary: Background: Back pain and osteoporosis with vertebral fractures are common conditions in elderly women and significantly affect their quality of life. A common complication of osteoporosis are vertebral fractures. Treatment with bone-specific drugs does often not help the pain condition caused by the vertebral fractures even when the progress of the disease has decreased. Vertebral fractures often result in deformation of the spine and poorer quality of life of the individual. The spinal kyphosis also affects the lung function and the effect of the kyphosis itself is severe. Alternative treatments of back pain may lead to reduced drug demand for pain. Physical activity is one of the most important factors that regulates bone mass and can also affect balance and fall risk positively. The back orthosis that we intend to use in the treatment study has been shown in some previous scientific studies to strengthen the muscles in the back and also decrease the pain.

Purpose: The purpose of the study was to evaluate the effect of treatment of back pain in elderly women with an activating functional orthosis versus treatment with a group of physiotherapeutic tools and a control group for a six-month treatment period and follow-up after 12 months from the start of study. The aim was also to study elderly women with osteoporosis and back pain in a follow-up study of a cohort of women at high risk of osteoporotic fractures, with focus on back pain, functional capacity and quality of life.

The aim was to study the effect of treatment with activating functional orthosis versus physiotherapeutic treatment in a group and a control group without treatment. The main outcomes will be the experienced perceived back pain and back extensor strength. Additional outcomes will be quality of life, balance, lung function and kyphosis. Biochemical markers for pain will be measured in the RCT (Randomized Controlled Trial).

Significance: Evaluation of alternative treatment methods such as exercise by a physiotherapist and treatment with a functional orthosis will give new additional treatment options for our patients. An activating functional orthosis could reduce the use of analgesics and increase the quality of life of the affected women.


Options:
A: Back pain as assessed by a numeric rating scale (Baseline and 10 weeks)
B: 10 meter habitual walking speed (Up to 18 months)
C: Back pain (Baseline and six months)
D: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (Median 2.7 years/Average 2.6 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Upper Airway Training for Treatment of Snoring Using Smartphone Application
Brief Summary: The objective of this study is to reduce the incidence or intensity of snoring in a patient population of known simple snorers without sleep apnea using smartphone based application which allows participants to play voice controlled games using various articulations resulting in tongue base movements.


Options:
A: Upper airway collapsability (3 months); Images from magnetic resonance (3 months); Negative expiratory pressure (3 months); Snore (3 months)
B: Snoring Intensity (12 weeks); Snoring Rate (12 weeks)
C: Apnea-hypopnea index (3 months)
D: objective sleep pattern (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants
Brief Summary: Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants


Options:
A: success rate in closing PDA using paracetamol in comparison to ibuprofen. (at Visit 3 (day 3).)
B: Days Spent on Supplemental Oxygen During the First 28 Days. (28 days of life)
C: closure of PDA (6 days)
D: Successful rate in closing PDA of ibuprofen administered at high or standard dose. (Between 84 and 96 hours of life)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants
Brief Summary: Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants


Options:
A: success rate in closing PDA using paracetamol in comparison to ibuprofen. (at Visit 3 (day 3).)
B: Incidence of respiratory morbidity (72 hours after birth)
C: closure of PDA (6 days)
D: Duration of the artificial ventilation after discontinuation of the opioid infusion (at time of extubation (expected to be within 48 hours following discontinuation of the opioid infusion))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Revealing Mechanisms and Investigating Efficacy of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis - a Multicentric Randomized Controlled Group Sequential Trial
Brief Summary: Infective endocarditis (IE) is associated with high hospital mortality for various reasons; one of them is circulatory failure in patients who undergo cardiac surgery for IE. One discussed reason underlying circulatory failure during surgery is the release of vasodilatatory mediators and cytokines. This study examines the efficacy and safety of a hemoadsorption filter which is approved for the reduction of the concentration of cytokines in the bloodstream.


Options:
A: SOFA Score (24 hours before until day 9 post-surgery)
B: IL-6 (1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours)
C: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
D: Reduction of systemic inflammatory response (Through study completion, an average of 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Single-center, Pilot Study of Envarsus XR® to Examine Safety, Medication Adherence, and Patient Reported Outcomes in Adolescent Renal Transplant Recipients
Brief Summary: Adolescents commonly experience barriers to adherence that entail forgetfulness, distraction, poor planning, and scheduling problems. A once daily oral regimen may be superior to the current regimens that require twice daily dosing. It is currently unclear if Envarsus XR® would improve outcomes in adolescent organ transplant recipients. Each patient will receive tacrolimus (twice daily immediate release oral formulation) which they are using as part of their standard of care immunosuppressive regimen for a portion of the study and Envarsus XR® (a once daily extended-release oral tacrolimus formulation) for a portion of the study in a cross-over design. Besides the advantage to adherence behaviors, a sustained-release tacrolimus preparation may decrease burdensome side effects and increase quality of life. Following enrollment, each patient will be maintained in the study for 9 months.


Options:
A: Incidence of clinical or subclinical allograft injury at any timepoint as assessed by the appearance of de novo donor specific anti-HLA antibody (dnDSA) OR biopsy proven allograft rejection. (9 months); Change in Patient Reported Transplant Symptoms (Baseline, 2.5 months, 4.5 months, 7 months, 9 months); Change in Patient Reported Medication Adherence and Barriers (Baseline, 2.5 months, 4.5 months, 7 months, 9 months); Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) as a measure of safety (2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 months); Change in Patient Reported Distress (Baseline, 2.5 months, 4.5 months, 7 months, 9 months)
B: Difference in adherence to immunosuppressant medications between intervention and control (self-report) (3 months and 12 months after enrolment); Difference in adherence to immunosuppressant medications between intervention and control (immunosuppressant blood levels) (3 months and 12 months after enrolment)
C: Medication Adherence (six months)
D: 90- day readmission (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use Of Music Therapy In Autism Spectrum Disorder
Brief Summary: Music therapy is an established form of creative art therapy. By using music as a specific medium of communication, expression and adapting it to the individual resources and abilities of the patient, music therapy can be beneficial in activating and supporting mental and psycho-physical recover .


Options:
A: The Arabic Language test (Baseline,Change from Baseline at the end of 12 Months Music Therapy .)
B: Changes of Childhood Autism Rating Scale-2 (Pre-test 2 weeks before Day 1); Changes of Childhood Autism Rating Scale-2 (2 weeks after intervention); Changes of Childhood Autism Rating Scale-2 (4 months after intervention); Changes of Social Responsiveness Scale second edition (Pre-test 2 weeks before Day 1); Changes of Social Responsiveness Scale second edition (2 weeks after intervention); Changes of Social Responsiveness Scale second edition (4 months after intervention); In-session social behavior (Day 1); In-session social behavior (Last intervention session, approximately 12 weeks after Day 1.)
C: Z-score change on Cognitive Functioning (0, 12 and 28 weeks)
D: Children's Communication Checklist-2 (12 weeks); Brain connectivity of frontotemporal regions (12 weeks)

Answer: A