TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy
Brief Summary: Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of this study is to compare the incidence of pancreatic fistula that is most crucial for surgical outcome and complications in pancreaticoduodenectomy with those of the control group and the TachoSil® apply group.

Patients who were planned to undergo pancreaticoduodenectomy without a history of chronic pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase 4 clinical trial.


Options:
A: Incidence of pancreatic fistula (At 3 days after surgery); Incidence of clinically relevant pancreatic fistula (At 5 days after surgery)
B: Rate of postoperative complications of grade > II according to Dindo-Clavien classification (90 days); Rate of overall postoperative complications (90 days); Rate of postoperative mortality (90 days)
C: The rate of pancreatic fistula between groups (postoperative 3rd day)
D: Pancreatic fistula development post distal pancreatectomy (30 days post surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PathMate2: The Impact of Health Information System Services on the Effects of Therapy in Overweight Teenagers
Brief Summary: Randomised controlled trial in overweight adolescents using a health App.


Options:
A: Change in weight at 6 months (baseline, 6 months)
B: Body Mass Index (12 months)
C: 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)
D: Change in measure of Health-related quality of life from baseline to 6-months follow up. (6-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Outcome Assessor-blinded Pilot Randomised Controlled Trial of an Ion-exchange Water Softener for the Prevention of Atopic Eczema in Neonates, With an Embedded Mechanistic Study
Brief Summary: An outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study


Options:
A: Trans Epidermal Water Loss(TEWL) (first 7 days of life)
B: Presence of eczema (12 months of age.); Confirmed diagnosis of food allergy at 12 months (52 weeks). (12 months of age)
C: Proportion of eligible families screened who are willing and able to be randomised. (Before birth)
D: Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum (60 months); Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined (60 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Outcome Assessor-blinded Pilot Randomised Controlled Trial of an Ion-exchange Water Softener for the Prevention of Atopic Eczema in Neonates, With an Embedded Mechanistic Study
Brief Summary: An outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study


Options:
A: Hierarchical criterion based on repeated measures of PO-SCORAD severity score (2 years); Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter (2 years)
B: Clinical improvement during UVA1/NB-UVB phototherapy using a validated; SCORAD index
C: Proportion of eligible families screened who are willing and able to be randomised. (Before birth)
D: Change in Eczema Area Severity Index (EASI) at end of treatment (week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Outcome Assessor-blinded Pilot Randomised Controlled Trial of an Ion-exchange Water Softener for the Prevention of Atopic Eczema in Neonates, With an Embedded Mechanistic Study
Brief Summary: An outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study


Options:
A: Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm (Day 28 +/- 3)
B: Proportion of eligible families screened who are willing and able to be randomised. (Before birth)
C: Trans Epidermal Water Loss(TEWL) (first 7 days of life)
D: Presence of eczema (12 months of age.); Confirmed diagnosis of food allergy at 12 months (52 weeks). (12 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention
Brief Summary: Reducing medications and associated side effects in older adults: an electronic hospital-based intervention


Options:
A: Successful medication discontinuation (4 months)
B: Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers) (Interview performed 30-35 days post-discharge.)
C: Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 3 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 6 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 12 months); Change from baseline in fall rate (Change from baseline in fall rate at 3 months); Change from baseline in fall rate (Change from baseline in fall rate at 6 months); Change from baseline in fall rate (Change from baseline in fall rate at 12 months)
D: Health-related quality of life as measured with 15D (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevenció Dels Problemes Relacionats Amb Alcohol a urgències.
Brief Summary: Alcohol use and its consequences represent an important public health problem. As well as alcohol dependence, hazardous drinking also contributes to a high burden in terms of morbidity and mortality. To improve these patients' prognosis and decrease associated social and health care costs, it is necessary to increase early detection, intervention and treatment for these problems. For these reasons, SBIRT programmes (Screening Brief Intervention and Referral to Treatment) have been developed, evaluated and shown to be effective, particularly in primary care and general practice. Nevertheless, effectiveness of SBIRT in emergency departments (ED) has not been clearly established.

The investigators aimed to evaluate the feasibility and efficacy of an SBIRT programme in the ED of a tertiary hospital.


Options:
A: Alcohol Use Disorders Identification Test score (3 months)
B: Proportion of Risky Drinkers Measured by AUDIT-C (6 weeks); Proportion of Patients Attending to Specialized Treatment (6 weeks)
C: Timeline Follow Back Assessing Number of Standard Drinks (3 months)
D: Drinks per drinking day (6 months); Rate of effective contraception (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing and Evaluating a Multi-Level Intervention to Increase Latrine Use and Safe Feces Disposal Among Latrine Owning Households in Rural Puri District, Odisha, India
Brief Summary: The objective of this research is to evaluate an intervention focused on increasing latrine use in rural Odisha India. The present study builds off of previous research, which resulted in the design of an intervention to increase latrine use. This research evaluates the intervention designed to determine if significant increases in latrine use are observed among those who received the intervention compared to those that did not. Qualitative research will supplement trial data collection to help explain findings and understand perceptions of the intervention.


Options:
A: Incidence of Diarrhea (2 weeks)
B: Change in Latrine Usage Rate (Baseline, Post-Intervention (Up to 1 Year))
C: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
D: Diarrhea in Children Under 5 (one year after the intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Parallel-group Randomized Trial to Compare the Efficacy of Different Behaviour Change Techniques in the e- and M-health Intervention 'MyPlan 2.0'
Brief Summary: The aim of this study is to investigate the effectiveness of intervention 'MyPlan 2.0' and the efficacy of the different behaviour change techniques that are included. Eight groups will be created that will receive a different version of the intervention, varying in three behaviour change techniques (action planning, coping planning, self-monitoring).


Options:
A: Change in objective physical activity (PA) (Baseline, 5 weeks, 3 months, 1 year); Change in objective sedentary behaviour (Baseline, 5 weeks, 3 months, 1 year); Change in self-reported physical activity (PA) (Baseline, 5 weeks, 3 months, 1 year); Change in self-reported sedentary behaviour (Baseline, 5 weeks, 3 months, 1 year)
B: Physical Activity Behavior (3 years)
C: To assess the effectiveness of a 6-month primary care intervention to reduce diary hours of Sitting time in overweight and obese patients, as well as to increase their weekly caloric spend (Baseline-6-9-12 and 18 month)
D: Change from control week and intervention week in total energy expenditure (TEE) (week 1 and week 2); Resting energy expenditure (REE) (Baseline (day 0)); Change from control week and intervention week in physical activity energy expenditure (PAEE) (week 1 and week 2); Change from control week and intervention week in daily time spent in sedentary (SB) (week 1 and week 2); Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities (week 1 and week 2); Change from control week and intervention week in number of breaks in sedentary time (BST) (week 1 and week 2); Change from control week and intervention week in time spent sitting (TSS) (week 1 and week 2); Change from control week and intervention week in time spent standing (TSst) (week 1 and week 2); Change from control week and intervention week in time spent walking (TSW) (week 1 and week 2); Change from control week and intervention week in number of steps (week 1 and week 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Inpatient Volume Expansion in Children With Shiga Toxin-Producing Escherichia Coli (STEC) Infection to Prevent Hemolytic Uremic Syndrome (HUS)
Brief Summary: This study will provide feasibility data regarding the conduct of a clinical trail evaluating the use of early aggressive inpatient intravenous rehydration in children with Shiga Toxin producing E. coli infection.


Options:
A: Time to death or serious extrarenal events (60 days); Time to dialysis (60 days)
B: the duration in days of extrarenal epuration (From the inclusion date and assessed up to 13 months)
C: Incidence of HUS development (4 weeks)
D: Number of children enrolled in the study protocol (at the end of the 24 month study recruiting period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With Oral Potentially Malignant Lesions (OPML) or Head and Neck Squamous Cell Carcinoma (HNSCC) (IHNPACT UMBRELLA)
Brief Summary: This is a multicenter minimal risk or burden prospective 3-cohort follow-up and monitoring study that aims to collect clinical, socio-psychological, medico-economics data and biospecimens for patients with oral potentially malignant lesions (OPML) or resectable head and neck squamous cell carcinoma (HNSCC) :

* Cohort A: OPML patients.
* Cohort B (specific design): smokers (adults who have smoked at least 100 cigarettes in their lifetime) motivated to quit - either current smokers (who currently smokes cigarettes every day (daily) or some days (nondaily)) or former smokers (adults who have smoked at least 100 cigarettes in their lifetime, but say they currently do not smoke) who stops smoking within 3 months prior to the diagnosis - with a resectable HNSCC requiring postoperative radiotherapy or chemoradiation.
* Cohort C: Patients with resectable HNSCC non-eligible to cohort B.

The primary objective of this study is the identification of biomarkers (predictive of malignant transformation or second primary tumor) and new strategies for prevention and therapy, mainly through extensive genomic, epigenomic and immune characterization of OPML and HNSCC.


Options:
A: Biomarkers (Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion)
B: to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients; exhaled carbon monoxide testing; and plasma cotinine measurements
C: Percent days abstinent of tobacco, alcohol and drugs (Past 90 days)
D: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Electronic Monitoring Combined With Weekly Feedback and Reminders on Adherence to Inhaled Corticosteroids in Infants and Younger Children With Asthma: a Randomized Controlled Trial
Brief Summary: A total of 96 recruited children (aged 6 months to 3 years) with mild or moderate persistent asthma who were on regular inhaled corticosteroids (ICS) were randomly allocated to receive electronic monitoring combined with instant messaging software -based weekly feeding back adherence and reminders to keep taking the ICS (intervention group) and to receive electronic monitoring only (control group). The device-monitored adherence rates and caregiver-reported adherence rates were analyzed.


Options:
A: device monitored adherence rate (up to 6 months)
B: Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) (6 months)
C: Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; ("Cohort 1: Data on Maintenance Use Supplied to Participant and HCP" and"Cohort 5: no Data Supplied to Participant or HCP") (Month 4 to Month 6)
D: Average Number of Days Without Asthma Symptoms (Symptom Free Days) (Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas
Brief Summary: The purpose of this research is to find the best dose of genetically modified T-cells, to study the safety of this treatment, and to see how well it works in treating patients with B cell non-Hodgkin lymphoma that has come back (relapsed) or did not respond to previous treatment (refractory).


Options:
A: Number of Participants With Dose-Limiting Toxicity (DLT) (From first dose of the combination agent until 1 month (28 days) after JCAR017 infusion (pre- JCAR017 cohort) or from JCAR017 infusion until 1 month (28 days) after the first dose of combination agent (post-JCAR017 cohort)); Complete Response Rate (CRR) (At 3 and 6 months post-JCAR017 infusion.)
B: Dose-limiting Toxicities (DLT) Rate (Up to 28 days)
C: Overall complete remission rate (Half a year)
D: Percent of participants recieving pembrolizumab per protocol schedule (21 days after first pembrolizumab infusion); Dose Timing part: Incidence of dose limiting toxicities (DLTs) (21 days after first pembrolizumab infusion); Expansion part: Overall response rate (ORR) (3 month post tisagenlecleucel infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: NoL Index, Heart Rate and Mean Arterial Blood Pressure Responses to Tracheal Intubation Performed With MacIntosh Blade Versus Glidescope
Brief Summary: Prospective, randomized and controlled who will be conducted in Maisonneuve-Rosemont hospital and whose objectives are:

* To observe if the alterations of the NoL index and the standard monitoring (Mean Arterial Blood Pressure and Heart Rate) (using the variability of NoL index and standard monitoring, peak NoL index and peak standard monitoring values, and number of time passed over their respective threshold for nociceptive response) are more accentuated after laryngoscopy using the classical MAC blade versus single-use disposable blade of the Glidescope.
* To observe the nociceptive response (using the variability of NoL index and standard monitoring, peak NoL index and peak standard monitoring values, and number of time passed over their respective threshold for nociceptive response) related to the insertion of endotracheal tube between vocal cords during the intubation.

Study plans to enroll 50 adult patients scheduled to undergo either general, gynecological, neurological, orthopedic, plastic or urological surgery under general anesthesia and who necessitate endotracheal intubation.


Options:
A: CERVICAL MOTIONS (January 2011 and December 2012)
B: Success Rate (10 minutes)
C: First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device. (During intubation procedure up to 1 hour); Time to Intubation (From the time the first device entered the patients mouth until successful intubation up to 1 hour)
D: Delta NoL (From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: International Phase III Randomised Study to Evaluate the Efficacy of Maintenance Therapy With Olaparib and Cediranib or Olaparib Alone in Patients With Relapsed Ovarian Cancer Following a Response to Platinum-based Chemotherapy
Brief Summary: ICON 9 will assess the efficacy, safety and tolerability of maintenance olaparib in combination with cediranib compared to maintenance olaparib alone following a response to platinum-based chemotherapy in women with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer. Prognostic and predictive factors will be studied from tumour and blood samples.


Options:
A: Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) (3 years)
B: Progression Free Survival (PFS) (From the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 5 years 5 months)
C: Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)); Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months))
D: objective response rate (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: International Phase III Randomised Study to Evaluate the Efficacy of Maintenance Therapy With Olaparib and Cediranib or Olaparib Alone in Patients With Relapsed Ovarian Cancer Following a Response to Platinum-based Chemotherapy
Brief Summary: ICON 9 will assess the efficacy, safety and tolerability of maintenance olaparib in combination with cediranib compared to maintenance olaparib alone following a response to platinum-based chemotherapy in women with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer. Prognostic and predictive factors will be studied from tumour and blood samples.


Options:
A: Overall Survival (Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.)
B: Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) (3 years)
C: progression free survival (12 months)
D: Progression-Free Survival (8 Months on average)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: International Phase III Randomised Study to Evaluate the Efficacy of Maintenance Therapy With Olaparib and Cediranib or Olaparib Alone in Patients With Relapsed Ovarian Cancer Following a Response to Platinum-based Chemotherapy
Brief Summary: ICON 9 will assess the efficacy, safety and tolerability of maintenance olaparib in combination with cediranib compared to maintenance olaparib alone following a response to platinum-based chemotherapy in women with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer. Prognostic and predictive factors will be studied from tumour and blood samples.


Options:
A: Percentage of Participants With an Overall Response Rate (an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.); Progression Free Survival (Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.)
B: Proportion of patients with objective response rate with recurrent endometrial cancer with mutated ARID1A (3 years); Proportion of patients with objective response rate with recurrent ovarian cancer with mutated ARID1A (3 years)
C: Median Progression-free Survival (PFS) in each study arm (average of 18 months)
D: Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study
Brief Summary: Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both rTMS and tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single rTMS stimulation in subacute stroke patients.


Options:
A: Neuroimaging Assessment (Change from baseline resting-state brain network at 8 weeks after intervention)
B: Change in compound motor score slope at week 4 (week 4 after treatment start); Change in alpha-band coherence between the affected motor cortex and the rest of the brain (Week 4)
C: Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) (6 weeks)
D: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)

Answer: A