TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Renal Failure: a Randomized Controlled Trial
Brief Summary: Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit (regional anticoagulation) has been advocated as the method of choice.However, citrate anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with frequent monitoring of acid-base and electolytes is also more challenging for the nurses and does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis in most of the patients. Citrate-based regional anticoagulation is therefore mainly advocated only for patients at high-risk of bleeding.

The investigators plan to implement an open-label randomized control trial assessing the effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI and with a special emphasis on the safety profile of this treatment in patients with severe liver failure.


Options:
A: Mean daily dialysis delivered dose during intensive care stay (dialysis days during intensive care stay)
B: N/A
C: Functions of inflammatory cells (24 hours); Regulation of inflammatory reactions and and opsonization in microorganisms (24 hours); Activity of acute phase protein during acute inflammation (24 hours)
D: Mean running time of a maximum of two consecutive haemodialysis circuits (seven days starting at time of HIT suspicion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Citrate-based Regional Anticoagulation Versus Heparin for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Renal Failure: a Randomized Controlled Trial
Brief Summary: Critically ill patients with acute kidney injury (AKI) are at high risk of bleeding on account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive procedures.In patients at high risk of bleeding, anticoagulation restricted to the circuit (regional anticoagulation) has been advocated as the method of choice.However, citrate anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis and hypocalcemia may occur.Implementation of citrate-based regional anticoagulation with frequent monitoring of acid-base and electolytes is also more challenging for the nurses and does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis in most of the patients. Citrate-based regional anticoagulation is therefore mainly advocated only for patients at high-risk of bleeding.

The investigators plan to implement an open-label randomized control trial assessing the effectiveness of citrate-based regional anticoagulation in critically ill patients with AKI and with a special emphasis on the safety profile of this treatment in patients with severe liver failure.


Options:
A: Functions of inflammatory cells (24 hours); Regulation of inflammatory reactions and and opsonization in microorganisms (24 hours); Activity of acute phase protein during acute inflammation (24 hours)
B: Mean daily dialysis delivered dose during intensive care stay (dialysis days during intensive care stay)
C: bleeding complications (during administration of study anticoagulant); transfusion requirement (during administration of study anticoagulant); filter survival (during hemofiltration)
D: Number of filters used per hour (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study of the Time Course of Response to Biphentin® Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting
Brief Summary: The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been formulated for daily dosing to provide treatment of a child with Attention deficit hyperactivity disorder (ADHD) for the substantial day.


Options:
A: SKAMP deportment rating scale (Week 8)
B: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
C: Comparison Following Treatment Between Drug and Placebo Using Evaluation by SKAMP Combined, Attention, and Deportment Scales (Average over all post-dose time points (1.0, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5, and 12 hours))
D: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) (Hour 4 of the of the Lab School Day during Double-Blind Assessment Period); Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) (Hour 4 of the Lab School Day During the Double-Blind Assessment Period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study of the Time Course of Response to Biphentin® Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting
Brief Summary: The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been formulated for daily dosing to provide treatment of a child with Attention deficit hyperactivity disorder (ADHD) for the substantial day.


Options:
A: State anxiety (1 year)
B: Clinicians Manuals from Russell A. Barkley as Disruptive Behavior Disorders Rating Scale--Parent Form (Form 4), Disruptive Behavior Disorders Rating Scale--Teacher Form (Form 5) and Clinical Interview--Parent Report Form (Form 6) (1 year)
C: Number of days of use of cannabis (12 weeks)
D: Comparison Following Treatment Between Drug and Placebo Using Evaluation by SKAMP Combined, Attention, and Deportment Scales (Average over all post-dose time points (1.0, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5, and 12 hours))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis.
Brief Summary: The general aim of this project is to conduct a randomized, double-blind, placebo-controlled clinical trial of azithromycin to determine whether treatment from infancy is safe and will prevent the onset of bronchiectasis. One hundred and thirty infants will be recruited from CF clinics in Australia and New Zealand and treated from 3 months to three years of age. The primary outcome will be the proportion with radiologically-defined bronchiectasis at 3 years of age. Safety and mechanistic evaluations will also be undertaken.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Proportion of children with radiologically-defined bronchiectasis (at three years of age); The proportion of lung tissue affected by disease (at three years of age)
C: Change in FEV1 From Baseline to End of Treatment at Day 168 (change from baseline to day 168)
D: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (Baseline and end of treatment Course 1 (Day 28)); Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses (Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing HIV/AIDS and Drug Abuse Among Heroin Addicts Released From Compulsory Rehabilitation in China
Brief Summary: The purpose of the study is to develop and pilot-test a Recovery Management Intervention (RMI) program for heroin addicts released from compulsory rehabilitation in China.

The project has the following specific aims:

Primary aims:

Aim 1. To engage key stakeholders in the local communities involved in supporting the transition of heroin addicts released from compulsory rehabilitation to the community; Aim 2. To identify potential barriers for participating in MMT in China; Aim 3. To develop and deliver educational/training materials on HIV risks, relapse prevention, and MMT; Aim 4. To adapt and develop the Recovery Management Intervention (RMI) program for heroin addicts released from compulsory rehabilitation in China; Aim 5. To conduct a pilot trial and obtain preliminary outcome data associated with RMI, relative to enhanced standard care.

Secondary aim:

Aim 6. To explore predictors of relapse and HIV/AIDS risk behaviors.

It is hypothesized that the intervention will reduce drug use relapse and the negative consequences associated with relapse, including HIV risk behaviors


Options:
A: prevalence of non-users of street opioid after one year of treatment will be compared between arms. (one year)
B: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month (6 months)
C: N/A
D: Primary Outcome Measure (5 years); Primary Outcome Measure (5 years); Primary Outcome Measure (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing HIV/AIDS and Drug Abuse Among Heroin Addicts Released From Compulsory Rehabilitation in China
Brief Summary: The purpose of the study is to develop and pilot-test a Recovery Management Intervention (RMI) program for heroin addicts released from compulsory rehabilitation in China.

The project has the following specific aims:

Primary aims:

Aim 1. To engage key stakeholders in the local communities involved in supporting the transition of heroin addicts released from compulsory rehabilitation to the community; Aim 2. To identify potential barriers for participating in MMT in China; Aim 3. To develop and deliver educational/training materials on HIV risks, relapse prevention, and MMT; Aim 4. To adapt and develop the Recovery Management Intervention (RMI) program for heroin addicts released from compulsory rehabilitation in China; Aim 5. To conduct a pilot trial and obtain preliminary outcome data associated with RMI, relative to enhanced standard care.

Secondary aim:

Aim 6. To explore predictors of relapse and HIV/AIDS risk behaviors.

It is hypothesized that the intervention will reduce drug use relapse and the negative consequences associated with relapse, including HIV risk behaviors


Options:
A: Treatment Progress (6 months)
B: Acceptability (Study months 21 through 34)
C: Opioid positive drug tests (4 and 12 months post-baseline)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavior and Driving Safety Study II
Brief Summary: The purpose of this study is to determine whether brief motivational interviews reduce problematic drinking behavior among individuals arrested for the first time for driving under the influence of alcohol (DUI).


Options:
A: Alcohol Use Disorders Identification Test score (3 months)
B: Reduction in injury recidivism (August 2011); Reduction in alcohol intake (August 2011); Reduction in alcohol problems (August 2011)
C: Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. (Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months)
D: The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up. (6-months); Percent Days Abstinent From Alcohol at 6 Months (6-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit
Brief Summary: Intensive care unit (ICU) hospitalization saves lives but often does so at a high personal cost to ICU survivors who frequently experience significant cognitive impairment and an array of physical and functional disabilities that limit their recovery and quality of life. While the problems experienced by these patients are likely amenable to rehabilitation, few ICU survivors receive focused rehabilitation. Recently, early physical rehabilitation in ICU patients has shown to improve the chances a patient will regain their pre-hospital functional status. Early cognitive rehabilitation for these patients has not yet been explored. This pilot study will determine the feasibility of early cognitive rehabilitation in ICU patients. The investigators will perform cognitive and physical rehabilitation, beginning in the earliest phases of critical illness, to determine the effect of these therapies on cognitive and functional outcomes in ICU survivors. The investigators hypothesize that combined cognitive and physical rehabilitation, started in the ICU, will improve recovery of cognitive and physical function as well as improve quality of life of ICU survivors.


Options:
A: Tower Test (3 months post hospital discharge)
B: atmospheric volatile concentration (daily); Sedation (daily); Feasibility (2 years); Education Tool (2 years); serum fluoride levels (every 2 days)
C: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
D: Ventilator free-days (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
B: Clinically Significant Laboratory Abnormalities. (28 Days)
C: Number of Participants With Treatment-Emergent Adverse Events (56 days)
D: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))
B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
C: Clinically Significant Laboratory Abnormalities. (28 Days)
D: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
C: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
D: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
B: Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal (Day 0 (baseline), Week 4)
C: Clinically Significant Laboratory Abnormalities. (28 Days)
D: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
D: to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination. (up to 48 weeks)

Answer: A