TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Outcome Measures For Physiotherapy Trials of Airway Clearance in Adults With Cystic Fibrosis
Brief Summary: This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London investigating outcome measures used in airway clearance trials.

Each participant will attend the research facility for two visits. Participants will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult CF.

Participants will perform the outcome measure (OM) tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be completed at the end of each study visit.

Analysis will be based upon differences in outcome measures and in-between study days.


Options:
A: Mean percentage change in forced expiratory volume in one second (FEV1) (7days)
B: Lung Clearance Index (90 minutes post treatment)
C: Hospital Length of Stay (Admission to Discharge)
D: Change in Lung Clearance Index (Immediately pre-intervention and immediately post-intervention); Change in Forced Expiratory Volume in One Second (Immediately pre-intervention and immediately post-intervention); Electronic Impedance Tomography (During intervention); Change in Impulse Oscillation System (Immediately pre-intervention and immediately post-intervention); Sputum Wet Weight (During intervention and for 30 minutes post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Outcome Measures For Physiotherapy Trials of Airway Clearance in Adults With Cystic Fibrosis
Brief Summary: This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London investigating outcome measures used in airway clearance trials.

Each participant will attend the research facility for two visits. Participants will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult CF.

Participants will perform the outcome measure (OM) tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be completed at the end of each study visit.

Analysis will be based upon differences in outcome measures and in-between study days.


Options:
A: Mean percentage change in forced expiratory volume in one second (FEV1) (7days)
B: Difference in the number of respiratory exacerbations during the 1 year study period (1 year)
C: Wet sputum production (45 minutes)
D: Change in Lung Clearance Index (Immediately pre-intervention and immediately post-intervention); Change in Forced Expiratory Volume in One Second (Immediately pre-intervention and immediately post-intervention); Electronic Impedance Tomography (During intervention); Change in Impulse Oscillation System (Immediately pre-intervention and immediately post-intervention); Sputum Wet Weight (During intervention and for 30 minutes post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemonitoring and Protocolized Case Management for Hypertensive Community Dwelling Seniors With Complex Care Needs
Brief Summary: Hypertension affects over 70% of Canadians over the age of 65y. Seniors with hypertension are at high risk for cardiovascular disease and death. Most of this risk is mediated through high blood pressure (BP). However, seniors are also at risk for side effects from BP lowering medication. These can be life threatening and costly. Therefore, BP monitoring is required to ensure BP levels are in the recommended range (neither too high nor low).

Home BP monitoring can be used to ensure that BP is in the right range and is recommended for all patients with high BP. Studies in other health care systems show that, to optimally perform home monitoring, the readings should be teletransmitted (electronically sent to the care provider). Additional studies indicate that BP control improves when health care providers (usually pharmacists or nurses) are specifically assigned to review teletransmitted BP readings and, using protocols, make therapeutic adjustments. However, a study needs to be conducted within the Canadian healthcare system to prove that telemonitoring±case management is cost-effective. In addition, proof that seniors consider telemonitoring to be usable and acceptable is required.

The investigators will conduct a 200 patient randomized trial in community-dwelling seniors that will compare home BP monitoring alone to telemonitoring plus case management, to comprehensively assess cost-effectiveness, usability, and acceptability. Our partners include TeleMED, a medium sized Canadian technology company with a wealth of experience in medical data management and transmission; Pharmacare, which will provide case-management services. The study will take place in seniors' supportive living residences; by virtue of residing in these institutions, these seniors have complex care needs. This intervention, if effective, cost-effective and safe, can be widely implemented.


Options:
A: Blood Pressure (24-hour Ambulatory Blood Pressure Monitoring, ABPM)) (one year)
B: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Massage Therapy and Hypopressive Abdominal Exercises on Chronic Non-specific Low Back Pain, Joint Mobility, Disability and the Patient's Quality of Life. A Controlled Clinical Trial
Brief Summary: The main goal of this study is to get to know if applying both, massotherapy plus hypopressive abdominal gymnastics (H.A.G) will reduce the pain of chronic non-specific low back pain. It actually reduces the inability produced by the pain and improve the patient's quality of life as well as the join range of the lumbar spine, way more than these two therapies applied separately.


Options:
A: Pain Scores (Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up)
B: Change from Self-reported lumbar pain intensity at 3 weeks. (At the start of the study, before the fifth treatment session (third week)); Change from Self-reported lumbar pain intensity at 5 weeks. (After the last treatment session (fifth week).); Change from Disability at 3 weeks. (At the start of the study, before the fifth treatment session (third week)); Change from Disability at 5 weeks. (After the last treatment session (fifth week).)
C: Timed Get-Up-And Go (Change from baseline to 12-week follow-up); PROMIS Health Assessment Questionnaire (Change from baseline to 12-week follow-up)
D: Pain intensity (Six weeks after randomization); Disability (Six weeks after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU: Study Protocol for a Randomised Controlled Against Placebo Trial
Brief Summary: Background: Alcohol is the leading psychoactive substance consumed in France, with about 15 million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA) considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for women. The specific complication of alcoholism is the alcohol withdrawal syndrome. Its incidence reaches up to 30% and its main complications are Delirium Tremens, restlessness, extended hospital stay, higher morbidity, psychiatric and cognitive impairment. Without appropriate treatment, Delirium Tremens can lead to death in up to 50% of patients.

Methods/Design: This prospective, randomised, controlled study versus placebo will be conducted in eighteen French intensive care units (ICU). Patients with an alcohol intake higher than the NIAAA threshold, under mechanical ventilation, will be included. The primary objective is to determine whether Baclofen is more efficient than placebo in preventing restlessness-related side effects in ICU. Secondary outcomes include mechanical ventilation duration, length of ICU stay, cumulative doses of sedatives and painkillers received within 28 days of ICU admission. Restlessness-related side effects are defined as unplanned extubation, Medical disposal removal, falling out of bed, ICU runaway, immobilisation device removal, self-aggression or towards medical staff. Daily doses of Baclofen/placebo will be guided by creatinine clearance assessment once a day.

Discussion: Restlessness in alcoholic patients is a life-threatening issue in ICUs. BACLOREA is a randomised study assessing the capacity of Baclofen to prevent agitation in mechanically-ventilated patients. Enrolment of 314 patients will begin in June 2016 and is expected to end in December 2019.


Options:
A: alcohol consumption (12 weeks)
B: Total alcohol abstinence; cumulative abstinence duration (12 weeks)
C: Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 (Baseline and month 6)
D: Occurrence (yes or no) of agitation-related adverse events (at the end of treatment (22 days max))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of An Innovative Smartphone Intervention for Smoking Cessation
Brief Summary: The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides higher quit rates than the current standard smoking cessation app.


Options:
A: Number of Participants Who Stopped Smoking by 6 Month Post Treatment (6 months)
B: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)
C: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
D: 30-day point prevalence abstinence (12 month post randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of An Innovative Smartphone Intervention for Smoking Cessation
Brief Summary: The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides higher quit rates than the current standard smoking cessation app.


Options:
A: Point prevalence abstinence at 6 months (6 months after beginning treatment)
B: 30-day point prevalence abstinence (12 month post randomization)
C: 7-day point prevalence (3 months and 6 months post treatment)
D: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised Study
Brief Summary: Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.

Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups.


Options:
A: Failure Rate of the Three Treatment Arms Judged Clinically (2 years)
B: Proportion of Subjects With All Caries Arrested (Two years); Prevalence of Dental Caries as Measured by a Clinical Oral Examination (Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first.)
C: Success (re-intervention required no/yes) (36 month)
D: Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device. (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mobile, Semi-automated Text Message-based Intervention to Prevent Perceived Low or Insufficient Milk Supply
Brief Summary: The purpose of this pilot randomized trial is to determine the effectiveness, feasibility, and acceptability of a mobile, semi-automated text message-based intervention (MILK) to prevent perceived low or insufficient milk supply (PIM) among mothers without prior breastfeeding experience. PIM is the leading cause of premature breastfeeding cessation, and prior work shows that it is often rooted in low breastfeeding self-efficacy and misconceptions about lactation physiology and trajectory. The MILK intervention is designed to address PIM, as well as other common breastfeeding problems via semi-automated text messages of prenatal and postpartum breastfeeding education and support. Messages are time-sensitive (e.g., specific to gestational age, time since delivery) and based on the Breastfeeding Self-Efficacy (Social Cognitive) Theory; they are also modeled from pilot work that investigated how first-time mothers view, manage and describe breastfeeding problems. Messages were vetted with clinical lactation experts, as well as pregnant and postpartum women with no other children.

The MILK intervention will be trialed against a control intervention group, who will receive general perinatal education through the national Text4Baby system. The investigators will recruit approximately 186 healthy, pregnant women at 13-25 weeks gestation from Magee Women's Hospital clinics and outpatient sites. Women will be randomized via computer-generated simple randomization to the experimental or control intervention. Both groups will receive text messages 3-5 times per week from week 25 of pregnancy through week 8 postpartum. Measured outcomes of interest will include perceived breast milk supply, breastfeeding confidence, maternal anxiety, breastfeeding exclusivity, and breastfeeding duration. Data will be collected at baseline (13-25 gestational weeks), 34-36 gestational weeks, and at 1, 2, 4, and 8 weeks postpartum via online survey or telephone call. To assess the potential longer-term impact of the intervention, breastfeeding continuation and exclusivity will be reassessed via telephone at 6 months postpartum. Between group and group x time differences in outcome measures will be examined graphically and via linear mixed modeling. To inform modifications to MILK, telephone interviews will be conducted with a subset of participants in each group to assess and compare intervention use, burdens and challenges, and suggested alterations (8 weeks).


Options:
A: Newborn survival (to 28 days) (July 2010 to June 2013)
B: Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely (3 months)
C: Perception of Milk Supply (8 weeks postpartum)
D: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Design and Clinical Evaluation of a School Meal With Deworming Properties
Brief Summary: Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due to IPs is greatest in school-age children who typically have the highest burden of infection. In 2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) of antihelminthic drugs to deworm children in developing countries. Though initially effective, there is concern that MDA might not be sustainable over extended periods especially considering the large children populations and the high frequency of dosing. Further, the MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to favor parasite genotypes that can resist anthelmintic drugs. There is hence a need for alternatives that are not only affordable and sustainable but easier to implement in the long term with a minimal chance of development of resistance. The investigators propose to develop and test the feasibility of a corn porridge meal fortified with papaya fruit extracts that have been shown to have antihelminthic properties. The investigators intend to evaluate its efficacy when given through school feeding programs and compare the outcome with albendazole- the recommended MDA agent for deworming school children. The investigators will design and formulate the product and test it among children in three primary schools in Western Kenya.


Options:
A: CD4 count (every 6 months for 24 months (enrollment and months 6, 12, 18, and 24 )); HIV-1 RNA level (enrollment, 12, and 24 months.)
B: parasite egg count (60 days after randomization)
C: Change in markers of HIV-1 disease progression (12 weeks); CD4 count (12 weeks); HIV-1 RNA level (12 weeks); Genital HIV-1 RNA levels (12 weeks)
D: Reduction of fecal egg counts at 14 days post-intervention. (At 14 days post-intervention.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation
Brief Summary: The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an ivacaftor-responsive CF transmembrane conductance regulator (CFTR) gene mutation.


Options:
A: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious (TEAEs) (Day 1 through Day 70); Part A: Observed Plasma Concentration of IVA and Their Metabolites (M1-IVA and M6-IVA) (Pre-dose, 2-4 hours, 6-8 hours, 24-60 hours post-dose); Part B +A/B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious (TEAEs) (Day 1 through Week 38); Part A/B: Observed Plasma Concentration of IVA and Their Metabolites (M1-IVA and M6-IVA) (Day 4 (pre-dose, 2-4 hours, 6-8 hours post-dose); Day 15 (pre-dose); Week 4 (pre-dose); Week 8 (pre-dose, 2-4 hours, 6-8 hours post-dose); Week 12 (pre-dose); Week 18 (pre-dose) and Week 24 (pre-dose))
B: Safety and Tolerability Based on Adverse Events (AEs) (Up to 14 days after last dose (last dose = Day 28))
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial
Brief Summary: This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.


Options:
A: Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale (At time of cervical dilation, 30 minutes after lidocaine administration)
B: Pain reported with cervical dilation (1 Year)
C: Pain at Time of Uterine Evacuation (During the procedure on Study Day 1)
D: Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure (5 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tocolytic Therapy for Preterm Labor in Multiple Gestation
Brief Summary: To compare the tocolytic efficacy oxytocin receptor antagonist (Atosiban) with that of calcium channel blockers (Nifedipine) among women with multiple gestation who present with threatened preterm labor.


Options:
A: gestational age at delivery (8 weeks)
B: Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation (4 years)
C: Duration of labor (48 hours)
D: Number of Participants With Delay of Preterm Delivery by 48 Hours. (Participants will be followed for the duration of the hospital stay, an expected average of 1 week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ENHANCE: Enhancing Brain Plasticity for Sensorimotor Recovery in Spastic Hemiparesis
Brief Summary: Many people who have had a stroke have problems recovering the use of their affected arm and these problems may persist for a long time. The investigators' research will test new ways to boost recovery by using non-painful brain stimulation together with training of arm movements using basic science principles. The training program will be done using the latest technology in rehabilitation such as virtual reality and robotics. The investigators will compare three groups of patients who have had a stroke. Each group will receive different combinations of brain stimulation and arm training. Another aspect of this proposal is that the investigators will do the same training programs in three different countries - Canada, Israel and India. In this way, the investigators will combine knowledge and skills to create training programs that can be applied anywhere in the world and that are not necessarily limited to high-income countries. Also, by combining expertise, the investigators will help to build the capacity to do research in India, a middle-income country that has great potential to contribute new knowledge to rehabilitation medicine.


Options:
A: 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)
B: Neuroimaging Assessment (Change from baseline resting-state brain network at 8 weeks after intervention)
C: Change in active control zone of the elbow (2 weeks and 1 month)
D: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)

Answer: C