TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Assisted Guidance for Tobacco Dependence Interventions in Dental Offices
Brief Summary: Electronic dental records (EDR) are a potentially powerful tool to incorporate current scientific evidence into clinical practice by providing key information at the point of patient care. The investigators know that disseminating evidence-based guidelines is not sufficient to change clinical practice so innovative approaches need to be tested in dentistry. The composite expertise of the investigators and consultants on this project and a large group practice with multiple clinics utilizing one EDR are essential to address the aims of this study. This project will examine whether dentists and hygienists will assess interest in quitting and deliver a tobacco intervention more frequently when provided with computer assisted guidance compared to a control group. Specifically the investigators will measure the delivery of questions assessing willingness to change and appropriate interventions based on willingness to change by measuring the recording of these activities in the EDR and patient receipt of these recommendations through a phone survey. In addition, the study will do a qualitative assessment of the patient perceived value of the provider-patient encounter to further inform us about patient perception of this interaction. The investigators want to know if dental providers will utilize these tools during the dental encounter. If they are used, the investigators would propose further studies examining smoking cessation rates. The investigators were not able to measure cessation rates due to the short two year timeline of this funding mechanism. This tool has potential application for other clinical topics, which makes this approach very innovative when considering the translation of evidence into the unique clinical practice of dentistry.


Options:
A: Patient report (Within 3 days of the dental encounter)
B: Frequency of women receiving the cessation smoking advice (Interviews during the first 12 hours after delivery)
C: Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients
D: Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less; Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention; Continuous abstinence rate for 1 year; Change of stage in the smoking cessation process

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Assisted Guidance for Tobacco Dependence Interventions in Dental Offices
Brief Summary: Electronic dental records (EDR) are a potentially powerful tool to incorporate current scientific evidence into clinical practice by providing key information at the point of patient care. The investigators know that disseminating evidence-based guidelines is not sufficient to change clinical practice so innovative approaches need to be tested in dentistry. The composite expertise of the investigators and consultants on this project and a large group practice with multiple clinics utilizing one EDR are essential to address the aims of this study. This project will examine whether dentists and hygienists will assess interest in quitting and deliver a tobacco intervention more frequently when provided with computer assisted guidance compared to a control group. Specifically the investigators will measure the delivery of questions assessing willingness to change and appropriate interventions based on willingness to change by measuring the recording of these activities in the EDR and patient receipt of these recommendations through a phone survey. In addition, the study will do a qualitative assessment of the patient perceived value of the provider-patient encounter to further inform us about patient perception of this interaction. The investigators want to know if dental providers will utilize these tools during the dental encounter. If they are used, the investigators would propose further studies examining smoking cessation rates. The investigators were not able to measure cessation rates due to the short two year timeline of this funding mechanism. This tool has potential application for other clinical topics, which makes this approach very innovative when considering the translation of evidence into the unique clinical practice of dentistry.


Options:
A: N/A
B: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)
C: Patient report (Within 3 days of the dental encounter)
D: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects on the Septic Patient's Microcirculation of the Transfusion of Three Different Types of Concentrated Red Blood Cells.
Brief Summary: Aim of the study is to evaluate the effects, on microcirculation of septic patient, of three types of RBCs: 1- fresh standard RBCs (storage \<10 days); 2-leukodepleted RBCs and 3-old standard RBCs (storage \>15 days) respectively. Before and 1 hour after the transfusion, microcirculation is evaluated using Sidestream Dark Field Imaging (SDF) and Near InfraRed Spectroscopy (NIRS) with vascular occlusion test. We also monitor temperature, heart rate, mean blood pressure, hemochrome, blood gases, blood lactates and SOFA score.


Options:
A: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality (2 weeks, 4 weeks, 12 weeks, 90 days)
B: Microcirculatory Flow Index (MFI) before and after blood transfusion. (One hour after the end of blood transfusion compared with before blood transfusion)
C: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
D: Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery. (30 days post surgery.); Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events (30 days post surgery); Effect of RBC Age on Occurrence of Neurologic Events (30 days post surgery.); Effect of RBC Age on Occurrence of Pulmonary Events. (30 days post surgery.); Effect of RBC Age on Occurrence of Renal Failure (30 days post surgery.); Effect of RBC Age on Occurrence of Infection Events (30 days post surgery.); Effect of RBC Age on Occurrence of Atrial Fibrillation (30 days post surgery.); Effect of RBC Age on Occurrence of Asystole (30 days post surgery.); Effect of RBC Age on Occurrence of Gastrointestinal Events (30 days post surgery.); Effect of RBC Age on Occurrence of Any Reoperation (30 days post surgery.); Effect of RBC Age on Occurrence of Vascular Events (30 days post surgery.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Obesity in the Worksite: A Multi-Message, Multi-"Step" Approach
Brief Summary: The purpose of this research study is to develop, implement, and evaluate a multi-component obesity prevention program in a workplace setting. A quasi-experimental design will be utilized, with hospital employees receiving the intervention and clinic employees serving as the comparison group. It is hypothesized that the intervention group will see greater changes in healthier eating, increased participation in physical activity, and reduced risk for obesity (weight, BMI, waist circumference).


Options:
A: Change from baseline in experienced community of practice at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in well-being at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in dietary behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in exercise behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in safety behavior counts at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline safety behavior consistency at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months)
B: Smoking Abstinence for 7 Days at Last Contact (6-12 months)
C: Biochemically verified smoking cessation rates at 6 months post-quit date
D: Change in Body Weight (Baseline, 6 months, 12 months); Change in Waist Circumference (Baseline, 6 months,12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Cholestasis in Premature Infants Using SMOFLipid®
Brief Summary: Preterm infants of extreme low birth weight (ELBW, \< 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for liver complications of PN, namely parenteral nutrition associated cholestasis (PNAC).

Intravenous lipid emulsions (ILE) based on soy bean oil are standard of care for provision of energy and essential fatty acids in preterm infants. However, they might be implicated in the pathogenesis of PNAC.

ILEs based on pure fish oil are proposed for therapy of PNAC. Recently a lipid emulsion containing 15 % fish oil together with soy bean, olive and MCT oil has become available in Europe (SMOFLIPID®). Such a balanced lipid emulsion might be more favourable than the standard soy bean oil emulsion (Intralipid®) concerning the development of PNAC. Furthermore ILEs containing fish oil might exert a positive effect on neurodevelopment. However, there are no data so far.

The study aims to evaluate the fish oil containing ILE "SMOFlipid®" for its protective effect against PNAC in ELBW infants compared to standard treatment with the soy bean based ILE "Intralipid®". Furthermore neurodevelopment at 12 and 24 months of corrected gestational age will be investigated.


Options:
A: Incidence of parenteral nutrition associated cholestasis (PNAC) (Participants will be followed for the duration of hospital stay (expected average 14 weeks))
B: Mean serum conjugated bilirubin (umol/L) (12 weeks)
C: Incidence of cholestasis (From recruitment to full enteral feeding per mouth (up to 90 postnatal days))
D: lipometabolism (Change from Baseline in fatty acid at 7 days and 14 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pharmacovigilance Study on the Safety of Integrated Treatment of Trachoma and Lymphatic Filariasis in Children and Adults Living in the Sikasso Region of Mali
Brief Summary: The purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin together and a week later to treat with azithromycin in areas co endemic for lymphatic filariasis and trachoma.


Options:
A: All-cause Mortality Rate in Children Aged 1-60 Months (24 Months); All-cause Mortality Rate in Children Aged 1-60 Months (36 months)
B: The prevalence of ocular chlamydia infection in a village as determined by PCR
C: Establish the incidence of adverse events associated with the mass triple drug administration (From Day 0 to Day 15 post treatment)
D: The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 36 months versus 0 months for Aim 1, at 36 months for Aim 2 and Aim 3) (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients (INSPiRE-TMS) A Randomized Trial Comparing a Patient Centered Support Program Versus Conventional Car
Brief Summary: Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial infarction. Poor adherence to evidence based secondary prevention regimens is frequently seen. Support programs for patients may not only improve adherence to recommended therapies but also reduce the recurrence rate of stroke and heart attack. The investigators hypothesize that compared to regular care, a structured and patient centered secondary prevention program will lead to a relative risk reduction of at least 28% of recurrent vascular events.


Options:
A: Changes from baseline in body weight. (Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).)
B: Medication utilization; Best Practices; Recurrent stroke
C: Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death (Up to 6 years from inclusion)
D: Reduction in systolic blood pressure taken by study team at home visit (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients (INSPiRE-TMS) A Randomized Trial Comparing a Patient Centered Support Program Versus Conventional Car
Brief Summary: Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial infarction. Poor adherence to evidence based secondary prevention regimens is frequently seen. Support programs for patients may not only improve adherence to recommended therapies but also reduce the recurrence rate of stroke and heart attack. The investigators hypothesize that compared to regular care, a structured and patient centered secondary prevention program will lead to a relative risk reduction of at least 28% of recurrent vascular events.


Options:
A: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
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: Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death (Up to 6 years from inclusion)
D: Sodium intake (12 months); Fruit/vegetable intake (12 months); Physical activity (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)
Brief Summary: The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.


Options:
A: The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access (1 year)
B: All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure) (1 year)
C: All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability (24 months)
D: All-cause Death or Disabling Stroke to Two Years (2 Years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Study of RBC Transfusion in Children With Severe Anemia
Brief Summary: The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia.


Options:
A: Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital (4hrs)
B: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
C: Measure of Non-transferrin-bound Iron (four hours after transfusion)
D: Reduction of elevated levels of blood lactate during 24 following RBC transfusion (24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Study of RBC Transfusion in Children With Severe Anemia
Brief Summary: The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia.


Options:
A: Reduction of elevated levels of blood lactate during 24 following RBC transfusion (24 hours)
B: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
C: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)
D: Postoperative Functional mobility; Restricting factors for functional mobility

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control
Brief Summary: The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD


Options:
A: FEV1 AUC 0-12 on Day 7 (Day 7)
B: Percentage of Patients to Experience Any Treatment-emergent Adverse Event (Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52))
C: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24); Trough FEV1 Response at Week 24 (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.); Mahler Transitional Dyspnea Index Focal Score at 24 Weeks (Baseline, Week 24); Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis (Baseline, Week 24)
D: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline (BL) and Day 85)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control
Brief Summary: The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD


Options:
A: Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24 (Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29)
B: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169 (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169); Trough FEV1 Response on Day 170 (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274). (Day 169)
C: FEV1 AUC 0-12 on Day 7 (Day 7)
D: Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (64 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lactobacillus Reuteri in Treatment of Functional Abdominal Pain and Chronic Constipation in Children - Randomized, Double Blind, Placebo Controlled Study
Brief Summary: Beneficial therapeutic effect of probiotics has been reported in children with irritable bowel syndrome, but not consistently in other functional gastrointestinal disorders. Although there is evidence that probiotics increase stool frequency and decrease stool consistency in healthy individuals the evidence for efficacy in constipation is limited.

Children with functional abdominal pain (FAP) and constipation will be included in the study. Children with FAP will be randomized in one of two groups and will receive either L. reuteri in a daily dose of 108 CFU, or placebo during three months. Children with chronic constipation will receive either L. reuteri in a daily dose of 108 CFU and lactulose, or placebo and lactulose. Frequency and intensity of episodes of abdominal pain during and after intervention will be recorded in children with FAP. Frequency of defecation, stool consistency and need for lactulose will be recorded in children with chronic constipation.


Options:
A: Frequency and intensity of abdominal pain (Eight weeks)
B: Intensity of abdominal pain (3 months); Severity of chronic constipation (3 months)
C: Abdominal Pain Frequency (16 weeks from the enrollment)
D: Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week (baseline and week 8)

Answer: B