TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Dose, Open Label, Randomized, Cross-over Study in Participants With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94-9027 and Adynovi
Brief Summary: This study is being conducted to compare how the body distributes and excretes the drugs Jivi (BAY 94-9027) and Adynovi. Jivi is a recently approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). Both drugs are FVIII products which have been manufactured via recombinant technology and have an extended half-live, i.e. they will stay longer in the body than other FVIII products. Therefore these products act longer in the body which reduces the frequency of drug injections. To compare the two drugs, a cross-over design was chosen, i.e. each patient will receive both products one after another.

Patients participating in this study will receive one dose of Jivi and one dose of Adynovi. Both drugs are injected into a vein. Observation will last for about 10 weeks, and blood samples will be taken from the participants to measure the blood levels of FVIII. Generic name of Jivi is Damoctocog-alfa-pegol, generic name of Adynovi is Rurioctocog alfa pegol.


Options:
A: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized) (Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.); Number of Subjects Developing Inhibitors Against Factor IX (FIX) (Up to 27.7 months (maximum))
B: Number of adverse events (AEs) (From first trial drug administration (day 1) to 11 weeks after the first trial product administration)
C: Evaluate the efficacy, safety and pharmacoeconomic of long-term secondary prophylaxis with Kogenate Bayer in comparison to on-demand treatment with Kogenate Bayer in terms of joint bleeding episodes per year (Every 6 months)
D: Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for BAY 94-9027 (Pre-dose to 120 hours after the end of the infusion); Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for Adynovi (Pre-dose to 120 hours after the end of the infusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Respiratory Effect of the LISA (Less Invasive Surfactant Administration) Method with Sedation by Propofol Versus Absence of Sedation: Double-blind Comparative Randomized Clinical Trial.
Brief Summary: The investigators propose to evaluate premedication with Propofol compared to a control strategy including a placebo with a possible rescue treatment with ketamine to ensure pain control before LISA Procedure . Investigators hypothesize that sedation with Propofol is safe and non-inferior to placebo for the risk of Mechanical Ventilation in the 72 hours following the procedure.


Options:
A: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
B: need for mechanical ventilation after the procedure (72hours)
C: Death or physiological bronchopulmonary dysplasia (36 weeks post menstrual age)
D: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison to Short-duration Tourniquet Total Knee Arthroplasty (TKA) With the Aquamantys® Bipolar Sealer and the Standard of Care in the Setting of Outpatient TKA: A Randomized, Double-blinded Study
Brief Summary: The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption and patient function during the first three months after short-stay total knee replacement between patients treated with short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).

By doing this study, investigators hope to learn if short duration tourniquet knee replacement with the Aquamantys® bipolar sealer is more effective than standard of care (tourniquet used throughout the case and no Aquamantys®). The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption and patient function during the first three months after short-stay total knee replacement between patients treated with short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).


Options:
A: Length of hospital stay (participants will be followed for the duration of hospital stay, an expected average of 3 days").)
B: isometric quadriceps-force measured (pre operatively and 48 hrs post op)
C: Biochemical Data (During operation 60 min Ischemia/Shame-Ischemia Time)
D: Isometric Quadriceps Strength (2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
Brief Summary: Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.


Options:
A: Change in Pain Scores on the numeric rating scale at 3 days (2 hours after delivery time and be continued every 6 hours for 3 days.)
B: use of analgesia during hospitalization (24 hours post partum)
C: Opioid Consumption in MME (within 24 hours of delivery)
D: Reduction in the level of perineal pain (3 days); Reduction in perineal swelling (3 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Randomized Clinical Trial in Subjects With Irritable Bowel Syndrome for the Identification of Gluten Sensitivity
Brief Summary: The aim of our study will be to establish in how many subjects with gastrointestinal symptoms and previous diagnosis of irritable bowel syndrome (IBS), the clinical picture is attributable to non celiac gluten sensitivity (NCGS) or fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) intolerance. For this purpose, all subjects with IBS will take a low FODMAPs diet, which implies the absence of cereals and consequently of gluten, and those presenting symptom improvement during this dietary treatment, will be exposed to a double-blind gluten or placebo challenge, to make a diagnosis of NCGS.


Options:
A: How many patients were still following a gluten-free or a wheat-free diet (Between July and November 2016)
B: Small-bowel mucosal morphology and inflammation (One year)
C: Clinical relapse (6 months)
D: Identification of FODMAP intollerance in IBS subjects (4 weeks); Identification of NCGS in IBS subjects who responded to low FODMAPs diet (3 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
Brief Summary: A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).


Options:
A: Level of Depression as assessed by the HAM-D (Day 1-7)
B: Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) (Up to 7 days following the last dose of study drug (Up to 23 days)); Part 1: Number of Participants With Serious Adverse Events (SAEs) (Up to 30 days following the last dose of study drug (Up to 46 days)); Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 16 days)); Part 2: Number of Participants With AEs (Up to 7 days following the last dose of study drug (Up to 35 days)); Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 28 days))
C: Montgomery-Asberg Depression Rating Scale (8 weeks)
D: Change in MADRS Total Score From Baseline to Week 6 (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
Brief Summary: A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).


Options:
A: Episodes of Depression or Elation (15 months (duration of trial and 3 month follow-up))
B: Change in MADRS Total Score From Baseline to Week 6 (6 weeks)
C: Memory tests (Before ECT, after 6 ECT treatments, at the end of the ECT course)
D: qEEG assessed through the gamma bands (Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Live-Online Mindfulness-based Intervention for Families of Children With Epilepsy: Making Mindfulness Matter© Randomized Control Trial
Brief Summary: Epilepsy is a debilitating condition characterized by spontaneous, unprovoked seizures. Up to 80% of children with epilepsy (CWE) may face cognitive, psychiatric, and/or behavioral comorbidities with significant unmet mental health needs. Mindfulness-based interventions may provide an ideal vector to target unmet mental healthcare needs in patients with epilepsy and their families. The investigators propose the Making Mindfulness Matter© (M3) program as an intervention to improve health related quality of life and mental-health for CWE and their parents. M3 is live-online parent and child program that incorporates mindful awareness, social-emotional learning skills, neuroscience, and positive psychology. This pilot RCT is needed to refine the implementation of the intervention to families with a child with epilepsy, and collect information pertaining to the feasibility and effectiveness of the intervention in preparation for a subsequent multi-centred trial across Canada. Note: Due to COVID-19, the format has been modified for online delivery (from community-based) and the intervention has been restarted.


Options:
A: Feasibility of Making Mindfulness Matter© (M3) as a family treatment for children with epilepsy and their parents (Throughout the study enrollment period and over the 8 weeks of intervention.)
B: Change in Connor-Davidson Resilience Scale (CDRISC) from Baseline to week 8 (Baseline, week 8)
C: Change from Baseline in parent-rated self-control of the child (Baseline, 3, 5 and 9 months)
D: Attendance (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle Intervention Study
Brief Summary: Despite standardized intervention strategies, weight loss and weight loss maintenance largely differ from person to person. Factors which may contribute to these individual differences is current object of research.

In order to investigate predictors and barriers for weight management and to investigate two different dietary interventions and two different digital tools for weight maintenance, the LION-Study was designed as follows: Step I (screening, baseline phenotyping), step II (weight loss intervention with formula diet), step III (weight maintenance intervention with 4 intervention groups: low carb/newsletter; low carb/app; low fat/newsletter; low fat/app) and step IV (follow-up). Participants are required to attend visits at seven time points.

At screening (month 0) a telephone-based screening interview takes place, in order to test eligibility of the potential participant. If the person is eligible, two consecutive baseline face-to-face visits are planned during step I. After completion of the eight weeks weight loss intervention (month 3), an additional visit takes place followed by three consecutive visits in the weight maintenance step (month 6, 9 and 15). The study ends with a final visit after the follow-up (month 27). Additional contacts (face-to-face and telephone) take place during the weight loss intervention step. Participants will regularly receive a bag with the required formula diet meals. During these "pick up" appointments, the study team actively get in face-to-face contact with participants.

At the different visits, data are collected by questionnaires, medical investigations (e.g. MRI, motor function, resting metabolic rate), blood withdrawal as well as urine, feces and saliva sampling.

Primary objective is to evaluate the effect of two diets (low carb/low fat) and two digital tools (app/newsletter) on long-term weight loss maintenance 12 months after weight loss.

Secondary objective is to identify genetic, epigenetic, physiological, psychological and lifestyle factors that predict the success of weight loss and weight loss maintenance.


Options:
A: Weight maintenance 12 months after weight loss intervention (15 months)
B: Patients' subjective assessment of usability of the PRECIOUS system (At the end of the test (Session 5, week 12)); Satisfaction with the PRECIOUS system (At the end of the test (Session 5, week 12)); User's acceptance of the PRECIOUS system (At the end of the test (Session 5, week 12)); Effectiveness of the PRECIOUS system (At the end of the test (Session 5, week 12))
C: Weight (Baseline to 6-Months)
D: Fat mass (0, 3, and 12 months); Energy intake (0, 3 months); Body weight (0, 3, 12 months); Insulin resistance (HOMA-IR) (0, 3, 12 months); Glucose levels (0, 3,12 months); Glucose variability (0, 3,12 months); Sleep assessment (0, 3,12 months); Adherence (0, 3,12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Addition of Aerobic Training to Conventional Rehabilitation After Proximal Femur Fracture: a Randomized Controlled Trial
Brief Summary: The primary purpose of this study is to assess the feasibility of an arm cycle ergometer training in subjects with proximal femur fracture surgically treated. The secondary purpose of this randomized controlled clinical trial is to verify whether the addition of aerobic activity can increase motor performance compared to a conventional exercise program in which no aerobic activity is foreseen.


Options:
A: Analysis of feasibility (Up to 4 weeks)
B: Self-efficacy (2, 6, and 12 months post hip fracture); Exercise behavior and activity (2, 6, and 12 months post hip fracture); Subjective reporting of exercise (2, 6, and 12 months post hip fracture)
C: rate of falls compared between treatment arms
D: Lower extremity function (Short Physical Performance Battery (SPPB) (Change from baseline will be assessed at 6 and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Mindfulness-based Therapy vs. Relaxation in Prevention of Burnout in Medical Students : A Multicenter, Single Blind Randomized Controlled Study
Brief Summary: A recent survey exploring mental health in a large cohort of French medical students and young graduates (N = 21.768), observed that 68.2% of participants showed pathologic anxiety. A high level of depressive symptomatology was found in 27.7% of participants, while suicidal ideation was reported by 23.7%. Mindfulness Based Interventions are beneficial for health with a positive impact on mood, anxiety, and well-being. It thus can be hypothesized that such interventions could help to prevent anxio-depressive symptomatology in medical students.

The implementation of prevention programs to promote resilience to stress and empathy among medical students is a priority, included in French National Strategy for Health. Efficacy of Mindfulness Based Interventions in French university must be studied to confirm and strengthen their development. The originality of this project consists in the collaboration of medical schools from different cities and the longitudinal follow-up.

The purpose of this study is to assess the efficacy of a mindfulness-based therapy in burnout prevention in comparison to relaxation.


Options:
A: Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI) (at 12 months)
B: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
C: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)
D: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group, Phase III Study to Compare the Efficacy and Safety of JTZ-951 With Darbepoetin Alfa in Anemic Patients With Chronic Kidney Disease Receiving Maintenance Hemodialysis.
Brief Summary: JTZ-951 is a currently being developed as a treatment for renal anemia. This study aims to evaluate the efficacy and safety of JTZ-951 following a switch from erythropoiesis-stimulating agent (ESA) in Korean subjects receiving HemoDialysis with renal anemia.

This study is a Phase III, open, active-controlled, parallel-group, multi-center study.

The total duration of the study will be 30 weeks including screening, treatment and follow-up.


Options:
A: Difference in mean Hb level change during the evaluation period from baseline (evaluation period - baseline) between study arm and control arm (baseline and Week 20 to 24); Difference in mean Hb level between study arm and control arm during the evaluation period (baseline and Week 20 to 24)
B: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to 170 weeks)
C: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis) (Up to 4.3 person-years for CV follow-up time period); Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))
D: Change From Baseline in Hemoglobin (Hgb) at Week 4 (Baseline (Week -4, Week-2 and Day 1) and Week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903): A Multicenter, Single-blind, Randomised Controlled Trial
Brief Summary: Acute variceal bleeding is one of the critical complications in patients with cirrhosis. Due to remarkable improvements in diagnostic and therapeutic modalities such as vasoactive agents, endoscopic therapy and antibiotics, the overall prognosis has been improved during the past several decades. However, it is still associated with increased mortality that is still around 20% at 6 weeks.

Patients with advanced cirrhosis have an intense overactivity of the endogenous vasoactive systems characterized by arterial hypotension and low peripheral vascular resistance. Severe renal vasoconstriction in consequence of marked arterial vasodilatation in splanchnic circulation triggers the reduction of glomerular filtration rate, and thus induces acute kidney injury (AKI)/hepatorenal syndrome (HRS), which have been further implicated in the increasing mortality in patients with cirrhosis.

Renal functional magnetic resonance imaging (fMRI), a technique considered superior to the most common method used to estimate the glomerular filtration rate, allows for non-invasive, accurate measurements of renal structures and functions in both animals and humans. It has become increasingly prevalent in research and clinical applications. In recent years, renal fMRI has developed rapidly with progress in MRI hardware and emerging post-processing algorithms. Function related imaging markers could be acquired via renal fMRI, encompassing water molecular diffusion, perfusion, and oxygenation. The study will use phase contrast - MR angiography, intravoxel incoherent motion - diffusion weighted imaging (IVIM-DWI) and blood-oxgen-level-dependent (BOLD)-MRI to evaluate renal functional changes after using vasoactive medications in patients with cirrhosis.

The rationale for the use of vasoactive medications, including terlipressin and octreotide, is to produce splanchnic vasoconstriction and reduce portal blood flow and portal pressure, thereby underpinning the application of these vasoactive drugs in the management of cirrhotic patients with acute variceal bleeding. Meanwhile, terlipressin has been recommended as the international first-line pharmacological therapy for the treatment of HRS because terlipressin may improve renal hemodynamics, improve renal function and potentially enable HRS a reversible condition without the need of liver transplantation. However, the renal protection effect of terlipressin vs. octreotide remains unknown. In this study, the investigators aim to conduct a multicenter, single-blind randomized controlled trial to compare the renal protection effect of terlipressin vs. octreotide assessed by fMRI in the management of cirrhotic patients with acute variceal bleeding.


Options:
A: Survival (10 years)
B: Renal function (6 days)
C: Haemostasis (24 hours)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study
Brief Summary: This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP target \<120 mmHg versus \<140 mmHg.


Options:
A: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
B: Number of participants with composite of major CVD events (4 years)
C: the prevention of recurrent stroke. (Until the first recurrent stroke reaches a total of 339 between the two groups)
D: Recurrent stroke (five years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study
Brief Summary: This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP target \<120 mmHg versus \<140 mmHg.


Options:
A: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a median of 3.5 years ] (From randomization; for approximately a median of 3.5 years)
B: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
C: Number of participants with composite of major CVD events (4 years)
D: Primary composite outcome (4 years)

Answer: C