TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Trial of Contrast-enhanced Sonothrombolysis in Acute Ischaemic Stroke
Brief Summary: BACKGROUND: Thrombolytic drugs may dissolve blood vessel clots in acute ischemic stroke. The overall benefit of intravenous thrombolysis is substantial, but up to 2/3 of patients with large clots may not achieve re-opening of the vessel and up to 40% of the patients may remain severely disabled or die. Ultrasound accelerates clot break-up (lysis) when combined with thrombolysis (sonothrombolysis) and increases the likelihood of functional independence at 3 months. Adding intravenous ultrasound contrast (gaseous microspheres) further enhances the thrombolytic effect (contrast enhanced sonothrombolysis = CEST). Contrast enhanced ultrasound may also accelerate clot break-up in the absence of thrombolytic drugs (contrast enhanced sonolysis = CES).

HYPOTHESIS: Contrast enhanced ultrasound treatment administered within 4 1/2 hours after symptom onset may be given safely to patients with acute ischemic stroke, both to those receiving intravenous thrombolysis and those not receiving intravenous thrombolysis, and will improve clinical outcome.

AIMS: To compare efficacy and safety of contrast enhanced ultrasound treatment vs. no ultrasound treatment in patients with acute ischemic stroke receiving or not receiving intravenous thrombolysis.

STUDY ENDPOINTS: The primary endpoints are 1) neurological improvement at 24 hours (proof of concept) and 2) excellent clinical outcome at 3 months (effect). Secondary endpoints are bleeding complications (safety), brain damage (infarct size/location) and early clinical improvement (effect).


Options:
A: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS (Day 90); Change in lesion volume (Day 30)
B: Clinical: Functional handicap (90 days); Proof of concept: Early neurological improvement (22-36 hours)
C: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)
D: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS (Day 90); Reperfusion after 4-8 h (8 h); Infarct lesion volume after 30 days (Day 30); Safety & pharmacokinetic outcomes (Day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation
Brief Summary: This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.


Options:
A: Incidence and severity of acute rejection episodes (1 year)
B: Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra). (1 year)
C: Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. (Month 12 is Primary, Month 24 secondary)
D: To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR); Non-inferiority of the composite of graft loss and death at 52 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Per Operative Fluid Optimisation Comparison of an Automated Closed-Loop System Versus Current Practice in High Risk Abdominal Surgical Patient. A Prospective, Randomized Clinical Trial.
Brief Summary: Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate and high risk abdominal surgical patients. A novel closed-loop fluid administration system based on multi-parameter hemodynamic monitoring have been described recently. This prospective, randomized, surgeon and patient blinded study aims at comparing the cardiac output provided by either this closed-loop system or the anesthesiologist team in high-rish surgical patient elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon, France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart rate...) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of stay) between groups


Options:
A: Mean indexed cardiac output (J1 to J12 (Within the surgical hospital length of stay))
B: The volume of crystalloid solutions administered intraoperatively. (Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours)
C: Length of Stay (Up to 180 days.)
D: Preload independent state (6 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Correlational Study of Pulse Pressure Variation in Various Tidal Volume in Mechanically Ventilated Patients Under General Anaesthesia
Brief Summary: Mesquida, J et al showed there was a significant linear correlation between pulse pressure variations under tidal volume 6 ml/kg and 8 ml/kg in patients after the resuscitation phase of severe sepsis and septic shock. No study revealed the actual relationship between various PPV under different VT. So we hypothesized that there were relationship between various PPV in different tidal volume settings. The objective of this study was to examine the relationship between various PPV.


Options:
A: To increase the number of lungs that meet the eligibility criteria for transplantation (end of brain death diagnosis observation period)
B: invasive arterial blood pressure as a Measure of Safety (Day 1)
C: Incidence of Reperfusion Lung Injury (72 Hours)
D: Composite endpoint defined as incidence of major postoperative pulmonary (defined as pneumonia, need for noninvasive ventilation or need for invasive ventilation) and extrapulmonary (SIRS, sepsis and septic shock) complications (during the first seven days after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Double Blind, Parallel Group, Placebo-Controlled Dose Finding and Efficacy Study of VPD-737 in the Treatment of Subjects With Chronic Pruritus
Brief Summary: A study of a several doses of a novel treatment for chronic itch compared to placebo for patients whose condition has not responded to other treatments


Options:
A: Visual Analog Scale (6 weeks)
B: Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29 (Day 29); Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36); Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29 (Baseline, Day 29); Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29 (Baseline, Day 29)
C: Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 (Day 29); Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36); Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 (Baseline, Day 8); Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 (Baseline (Day 1), Day 36); Number of Participants With Clinically Significant Laboratory Values (Baseline up to Day 36); Percentage of Participants With Local Tolerability Symptoms at Baseline (Baseline (Day 1)); Percentage of Participants With Local Tolerability Symptoms at Day 8 (Day 8); Percentage of Participants With Local Tolerability Symptoms at Day 15 (Day 15); Percentage of Participants With Local Tolerability Symptoms at Day 22 (Day 22); Percentage of Participants With Local Tolerability Symptoms at Day 29 (Day 29); Percentage of Participants With Local Tolerability Symptoms at Day 36 (Day 36)
D: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Non-surgical Periodontal Therapy on Host Response and Microbiological Profile of Type 2 Diabetics With Periodontal Disease.
Brief Summary: Periodontitis, a chronic inflammatory disease which results in irreversible attachment loss, bone destruction and tooth loss, is a major oral health problem affecting 90.2% of Malaysian population. It was initially demonstrated that Type 2 Diabetes (T2D) was a risk factor for periodontitis and subsequently a two-way relationship between diabetes and periodontitis was proposed. Diabetes has been shown to cause defects in neutrophil function by overproduction of pro-inflammatory mediators such as Tumour necrosis factor-α, Interleukin-1β and Prostaglandin E2 by macrophages. The inflammatory mediators released in response to plaque have been reported to be insulin antagonists that disturb binding of insulin to its receptors and further complicate hyperglycaemia in T2D. The hyperglycaemia in diabetics promotes more pathogenic bacteria into the subgingival microenvironment making them more susceptible to chronic periodontitis. Studies however differ in the types of periodontal pathogens present in these pockets. At the same time, very few studies have quantified them. This study proposes to investigate the effect that non-surgical periodontal therapy (NSPT) has on the periodontal parameters, HbA1c levels, microbiological profile and CRP levels of T2D patients with chronic periodontitis as compared to oral hygiene education (OHE)alone.


Options:
A: Change in Glycosylated Hemoglobin (HbA1c) (6 months after randomization)
B: HbA1c percentage (At baseline and 120 days after treatment)
C: Metabolic (3 months)
D: Effect of periodontal intervention on plaque score levels in diabetics with periodontal disease (Changes from baseline to 3 months); Effect of periodontal intervention on gingival bleeding index of diabetics with periodontal disease (Changes from baseline to 3 months); Effect of periodontal intervention on probing pocket depths of diabetics with periodontal disease (Changes from baseline to 3 months); Effect of periodontal intervention on probing attachment levels of diabetics with periodontal disease (Changes from baseline to 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Web and Mobile Smoking Cessation Interventions
Brief Summary: This study seeks to develop and then perform a controlled efficacy Randomized Controlled Trial assessing tobacco abstinence of a best-practices Web-based PC-delivered smoking cessation intervention (QuitOnline) compared to a Mobile Smartphone-delivered intervention (MobileQuit). Study participants are randomized to one of two conditions: a Web Only intervention and the Web+Mobile intervention. The hypothesis is that the Web+Mobile approach will yield greater efficacy than the Web Only condition.


Options:
A: Change in all-tobacco abstinence from enrollment to 3 months and 6 months post enrollment (Change from enrollment to 3 months and 6 months post enrollment)
B: 30 day point prevalence of abstinence (6 months)
C: The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires. (24 months post intervention)
D: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder: a Controlled Trial in Taiwan
Brief Summary: The purpose of this study is to test the hypothesis:

Primary hypothesis: Participants in the dialectical behavior therapy group have greater reductions in the frequency and severity of suicidal and non-suicidal self-injurious behaviors compared to participants in the alternative treatment group.

Secondary Hypotheses: Participants in dialectical behavior therapy group have improved treatment outcomes compared to participants in alternative treatment, including mental health service utilization, symptoms of borderline personality and depression symptoms, suicidal thought and hopelessness, disability, and quality of life.


Options:
A: Suicide Attempt Self-Injury Interview (SASII) (4 months, 8 months and 12 months)
B: Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs (Measured post-treatment and at 6- and 12-month follow-ups); Depression, anxiety, and other psychiatric symptoms (Measured post-treatment and at 6- and 12-month follow-ups); PTSD diagnoses and symptom severity (Measured post-treatment and at 6- and 12-month follow-ups)
C: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
D: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder: a Controlled Trial in Taiwan
Brief Summary: The purpose of this study is to test the hypothesis:

Primary hypothesis: Participants in the dialectical behavior therapy group have greater reductions in the frequency and severity of suicidal and non-suicidal self-injurious behaviors compared to participants in the alternative treatment group.

Secondary Hypotheses: Participants in dialectical behavior therapy group have improved treatment outcomes compared to participants in alternative treatment, including mental health service utilization, symptoms of borderline personality and depression symptoms, suicidal thought and hopelessness, disability, and quality of life.


Options:
A: Columbia Suicide Severity Rating Scale Number of Participants Reporting Presence of Suicidal Behaviors (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Columbia Suicide Severity Rating Scale Number of Suicidal Behaviors (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); The Number of Participants Reporting Columbia Suicide Severity Rating Scale Suicidal Ideation Categories as Most Severe (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Columbia Suicide Severity Rating Scale Suicidal Ideation Intensity Scale Total Score (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Number of Participants With Readmissions (Assessed on a monthly basis for 6 months follow-up.)
B: Suicide Attempt Self-Injury Interview (SASII) (4 months, 8 months and 12 months)
C: Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010) (12 weeks); Self-harm and related hospital use as reported in National Health Service patient records (12 weeks)
D: Beck Depression Inventory (V2) (Baseline to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder: a Controlled Trial in Taiwan
Brief Summary: The purpose of this study is to test the hypothesis:

Primary hypothesis: Participants in the dialectical behavior therapy group have greater reductions in the frequency and severity of suicidal and non-suicidal self-injurious behaviors compared to participants in the alternative treatment group.

Secondary Hypotheses: Participants in dialectical behavior therapy group have improved treatment outcomes compared to participants in alternative treatment, including mental health service utilization, symptoms of borderline personality and depression symptoms, suicidal thought and hopelessness, disability, and quality of life.


Options:
A: Client Satisfaction Questionnaire (CSQ) (14 weeks); Cornell Services Index (CSI) (baseline, 14 weeks)
B: Change in Beck Scale for Suicide Ideation Score (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Suicide Attempt Index (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Index of Spouse Abuse Score (Baseline, Week 10, Post-treatment Months 6 and 12)
C: Suicide Attempt Self-Injury Interview (SASII) (4 months, 8 months and 12 months)
D: Suicide Mortality Rates (Study Completion (2 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Immigrant Families: Working Together To Move More and To Eat Well
Brief Summary: This project will broadly explore the efficacy of community participation in the design and implementation of an intervention to improve physical activity and nutrition among immigrant and refugee (Hispanic, Somali, Sudanese, Cambodian) families in Rochester, Minnesota


Options:
A: Infant weight for height (One year after study entry)
B: Change in Infant Growth (Baby is less than 2 months; baby is 3 months; baby is 6 months)
C: Improved dietary quality (Baseline- 24 months); Increased physical activity (Baseline- 24 months)
D: Waist circumference (10 months); BMI-Z score (10 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Immigrant Families: Working Together To Move More and To Eat Well
Brief Summary: This project will broadly explore the efficacy of community participation in the design and implementation of an intervention to improve physical activity and nutrition among immigrant and refugee (Hispanic, Somali, Sudanese, Cambodian) families in Rochester, Minnesota


Options:
A: Behavioural determinants of physical activity and nutrition by determinant questionnaire (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Physical activity, physical fitness and sedentarity (questionnaire and accelerometer) (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Food intake by 24h recall (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)
B: Improved dietary quality (Baseline- 24 months); Increased physical activity (Baseline- 24 months)
C: Change in the prevalence of overweight and obesity (Baseline, Month 9)
D: BMI-for-age z-score and percentiles (measured weight and height, self-reported gender and date of birth)and Body composition (Dual Energy X-ray Absorptiometry, and Bioelectrical Impedance Analysis) (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Therapeutic Option for Hepatitis B and C: a French Cohort
Brief Summary: * The cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers and behavioral data in a large number of patients and will be a leading equipment for crossdisciplinary and translational research on hepatitis.
* The cohort will be the main support for estimating the relative effects of treatments and for further cost-effectiveness studies on the management and treatment options in chronic HCV (Hepatitis C Virus)and HBV (Hepatitis B virus)infections.


Options:
A: Sustained Virologic Response (SVR)Rate (1.5 year)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) (Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)); Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods (Up to Week 14); Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period (Up to Week 12)
C: There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives. (From recruitment to the end of the cohort, with a minimum of one medical visit per year (the duration of follow-up is 7-8 years))
D: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (12 weeks after the last actual dose of study drug)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
Brief Summary: The aim of this study is to investigate whether a 4-week physical fitness training (target intervention) in stroke patients (subacute stage) increase the walking speed and activities of daily living compared with a control intervention (relaxation exercises). The target or control intervention is performed in addition to standard rehabilitation treatment.


Options:
A: Reach (Follow-up (week 16)); Retention (Follow-up (week 16)); Satisfaction with program (Post-intervention (week 9))
B: Dual-task cost on gait speed (4 weeks)
C: The number of steps taken per day by participants in each group (at baseline & at 6 weeks post randomisation)
D: Gait speed and Barthel Index (BI) (co-primary endpoint) (3 months post stroke vs baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
Brief Summary: The aim of this study is to investigate whether a 4-week physical fitness training (target intervention) in stroke patients (subacute stage) increase the walking speed and activities of daily living compared with a control intervention (relaxation exercises). The target or control intervention is performed in addition to standard rehabilitation treatment.


Options:
A: Aerobic capacity (Baseline,3month)
B: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)
C: Balance - Measured With the Berg Balance Scale (2 months)
D: Gait speed and Barthel Index (BI) (co-primary endpoint) (3 months post stroke vs baseline)

Answer: D