TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits of Tobacco Free Cigarette Among Heavy Smokers Undergoing a Lung Cancer Screening Program: a Randomized Controlled Study
Brief Summary: Background. Smoking is considered a global public health problem. For this reason, the smoking dependence was called by experts as a global epidemic.

Over the past three years, this electronic devices (Tobacco Free Cigarettes, or TFC) has been an important expansion in many countries. Nevertheless, there is poor evidence that TFC are beneficial for smoking cessation. In particular, even though it has been proved that the nicotine replacement devices helps many individuals to give up smoking and to tolerate the withdrawal symptoms, it is still unclear their long-term effect. Hence, it must be tested its contribution in tobacco reduction. This protocol in particularly innovative, since it aims to test the efficacy of electronic devices in a screening program (the lung cancer prevention program COSMOS II at the IEO), where tobacco reduction is strictly needed in order to lower individual's risk.

Methods and Design. This experimental protocol has been designed with the main aim to investigate the role of Tobacco Free Cigarettes (TFC), also called e-cigarettes, in helping smokers to improve their lung health and to quit or reduce tobacco consuming. In particular, the investigators aim at investigating clinical (physical symptoms, with particular focus on breathing quality and difficulties), the behavioral (number of tobacco cigarettes smoked), and psychological (wellbeing, mood and quality of life) effects of shifting to TFC.

The investigators will also analyze, as a secondary aim, the psychological and lifestyle component of smokers involved in order to fine correlation data that might be used to compute a predictor index able to suggest the probability of success, with respect to the reduction of tobacco consuming, of the use of a TFC and to maintain the abstinence. The study will be organized as a nested randomized controlled study with two arms: one experimental group and one control group. The study will be nested in the screening program for lung cancer, where subjects will be recruited.

All subjects will be entered in a psycho-cognitive low-intensity counseling program (6 months), but in the experimental group a TFC (with or without nicotine) will be used as replacement device for three months, while in the control group only low-intensity counseling will be provided. Furthermore, a low-cost non-invasive electronic device (the FitBit activity tracker) will be used in order to monitor behavioral (lifestyle), sleep quality and physical activities.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: Change in pulmonary health (dry cough, breath shortness, mouth irritation) index (baseline, 6 months, 12 months)
C: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
D: Comparison of Prolonged Abstinence (up to12 weeks post-quit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits of Tobacco Free Cigarette Among Heavy Smokers Undergoing a Lung Cancer Screening Program: a Randomized Controlled Study
Brief Summary: Background. Smoking is considered a global public health problem. For this reason, the smoking dependence was called by experts as a global epidemic.

Over the past three years, this electronic devices (Tobacco Free Cigarettes, or TFC) has been an important expansion in many countries. Nevertheless, there is poor evidence that TFC are beneficial for smoking cessation. In particular, even though it has been proved that the nicotine replacement devices helps many individuals to give up smoking and to tolerate the withdrawal symptoms, it is still unclear their long-term effect. Hence, it must be tested its contribution in tobacco reduction. This protocol in particularly innovative, since it aims to test the efficacy of electronic devices in a screening program (the lung cancer prevention program COSMOS II at the IEO), where tobacco reduction is strictly needed in order to lower individual's risk.

Methods and Design. This experimental protocol has been designed with the main aim to investigate the role of Tobacco Free Cigarettes (TFC), also called e-cigarettes, in helping smokers to improve their lung health and to quit or reduce tobacco consuming. In particular, the investigators aim at investigating clinical (physical symptoms, with particular focus on breathing quality and difficulties), the behavioral (number of tobacco cigarettes smoked), and psychological (wellbeing, mood and quality of life) effects of shifting to TFC.

The investigators will also analyze, as a secondary aim, the psychological and lifestyle component of smokers involved in order to fine correlation data that might be used to compute a predictor index able to suggest the probability of success, with respect to the reduction of tobacco consuming, of the use of a TFC and to maintain the abstinence. The study will be organized as a nested randomized controlled study with two arms: one experimental group and one control group. The study will be nested in the screening program for lung cancer, where subjects will be recruited.

All subjects will be entered in a psycho-cognitive low-intensity counseling program (6 months), but in the experimental group a TFC (with or without nicotine) will be used as replacement device for three months, while in the control group only low-intensity counseling will be provided. Furthermore, a low-cost non-invasive electronic device (the FitBit activity tracker) will be used in order to monitor behavioral (lifestyle), sleep quality and physical activities.


Options:
A: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)
B: Number of participants with 7-day point prevalence smoking abstinence (52 weeks)
C: Change in pulmonary health (dry cough, breath shortness, mouth irritation) index (baseline, 6 months, 12 months)
D: Continuous smoking abstinence rate (Weeks 9 to 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits of Tobacco Free Cigarette Among Heavy Smokers Undergoing a Lung Cancer Screening Program: a Randomized Controlled Study
Brief Summary: Background. Smoking is considered a global public health problem. For this reason, the smoking dependence was called by experts as a global epidemic.

Over the past three years, this electronic devices (Tobacco Free Cigarettes, or TFC) has been an important expansion in many countries. Nevertheless, there is poor evidence that TFC are beneficial for smoking cessation. In particular, even though it has been proved that the nicotine replacement devices helps many individuals to give up smoking and to tolerate the withdrawal symptoms, it is still unclear their long-term effect. Hence, it must be tested its contribution in tobacco reduction. This protocol in particularly innovative, since it aims to test the efficacy of electronic devices in a screening program (the lung cancer prevention program COSMOS II at the IEO), where tobacco reduction is strictly needed in order to lower individual's risk.

Methods and Design. This experimental protocol has been designed with the main aim to investigate the role of Tobacco Free Cigarettes (TFC), also called e-cigarettes, in helping smokers to improve their lung health and to quit or reduce tobacco consuming. In particular, the investigators aim at investigating clinical (physical symptoms, with particular focus on breathing quality and difficulties), the behavioral (number of tobacco cigarettes smoked), and psychological (wellbeing, mood and quality of life) effects of shifting to TFC.

The investigators will also analyze, as a secondary aim, the psychological and lifestyle component of smokers involved in order to fine correlation data that might be used to compute a predictor index able to suggest the probability of success, with respect to the reduction of tobacco consuming, of the use of a TFC and to maintain the abstinence. The study will be organized as a nested randomized controlled study with two arms: one experimental group and one control group. The study will be nested in the screening program for lung cancer, where subjects will be recruited.

All subjects will be entered in a psycho-cognitive low-intensity counseling program (6 months), but in the experimental group a TFC (with or without nicotine) will be used as replacement device for three months, while in the control group only low-intensity counseling will be provided. Furthermore, a low-cost non-invasive electronic device (the FitBit activity tracker) will be used in order to monitor behavioral (lifestyle), sleep quality and physical activities.


Options:
A: reducers (week-24 from baseline)
B: Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups (Baseline and 1 month)
C: Number of cigarettes smoked per day (End of 6 week intervention)
D: Change in pulmonary health (dry cough, breath shortness, mouth irritation) index (baseline, 6 months, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Food/Nutrient Based Interventions to Prevent Stunting Among Children Under Five in Thatta and Sujawal Districts, Sindh Province, Pakistan
Brief Summary: Widespread food insecurity and malnutrition are largely the main impairing factors for human capital development in Pakistan. Rates of chronic malnutrition are very high, and acute malnutrition is critical: 44% of children under five are stunted and nationwide global acute malnutrition (GAM) rates amongst children under five exceed the WHO critical threshold of 15%. Nutritional status trends also show a deteriorating situation since 1994, when stunting rates were at 36%.

This study evaluates the effectiveness of food based interventions to prevent stunting among children under-five years with focus on window of opportunity (1000 days from conception to 2 years) for addressing stunting. Pregnant women, lactating mothers and children 6-59 months will receive supplements on monthly basis in intervention areas, while participants in control areas will receive routine public health services available in the study area.


Options:
A: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
B: Product sales and use (coverage) (Every 2 weeks)
C: gut microbiota composition (Fecal sample after 2 months)
D: Stunting-reduction in stunted children in intervention group (2 Years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Paracetamol in Comparison to Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants: A Randomized, Open Label, Comparator-controlled, Prospective Study
Brief Summary: The purpose of the study is to assess the efficacy and safety of paracetamol in comparison to ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.


Options:
A: Days Spent on Supplemental Oxygen During the First 28 Days. (28 days of life)
B: Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen (Until discharge)
C: success rate in closing PDA using paracetamol in comparison to ibuprofen. (at Visit 3 (day 3).)
D: dichotomous variable: survival without BPD at 36 weeks PMA. (add 8 to12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Paracetamol in Comparison to Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants: A Randomized, Open Label, Comparator-controlled, Prospective Study
Brief Summary: The purpose of the study is to assess the efficacy and safety of paracetamol in comparison to ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.


Options:
A: Ductus diameter mm/kg (at postnatal age of 5 days); Cumulative dosage of morphine (at postnatal age of 5 days)
B: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
C: The Neonatal Pain, Agitation, and Sedation scale (8 month)
D: success rate in closing PDA using paracetamol in comparison to ibuprofen. (at Visit 3 (day 3).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to study the effect of anticoagulation in immune response with Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).


Options:
A: CRRT-filter life span in hours (during continuous renal replacement therapy up to 1 year); Overall survival in a 90day follow-up period (90 days)
B: the time of 1st membrane exchange (the time of 'filter is clotted')
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: Survival at 2 weeks after RRT (2 weeks after RRT in follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to study the effect of anticoagulation in immune response with Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).


Options:
A: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
B: 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)
C: Middle molecular weight molecules clearances (18 months)
D: Mean daily dialysis delivered dose during intensive care stay (dialysis days during intensive care stay)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to study the effect of anticoagulation in immune response with Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).


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: CRRT-filter life span in hours (during continuous renal replacement therapy up to 1 year); Overall survival in a 90day follow-up period (90 days)
C: Mortality (Day 28 after ICU admission)
D: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of this study was to investigate and compared the effects of cervical and scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for patients with chronic mechanical neck pain.


Options:
A: Headache days change from baseline for cervicogenic headache (0, 6, 12, 24, 39, 52 weeks)
B: Change in Neck pain intensity as measured by Visual Analog Scale (Change from baseline neck pain intensity at 4 weeks)
C: Pain intensity (week 8)
D: Pain Pressure Threshold (6 sessions)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multiple Dose, Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Assess the Effect of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combination on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.


Options:
A: Change in impact of COPD in daily life (Baseline and 3 months after baseline)
B: Change from baseline worst breathlessness intensity over the previous 24 hours (Week 1); Change from the baseline in the number of steps per day (Week 3)
C: Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment (Baseline and Week 4)
D: 6-Minute Walking Distance (Baseline and 8 weeks follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multiple Dose, Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Assess the Effect of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combination on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.


Options:
A: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)
B: Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment (Baseline and Week 4)
C: 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))
D: Identifying new patient subtypes and endpoints for COPD (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multiple Dose, Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Assess the Effect of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combination on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.


Options:
A: Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment (Baseline and Week 4)
B: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24)
C: Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) (From the start of study drug up to 52 weeks)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients
Brief Summary: In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC and venturi mask on early respiratory deterioration and patient's comfort in that setting. The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As respiratory deterioration occurs early after ICU admission, patients are randomized to receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary endpoints include comfort, dyspnea and thirst.


Options:
A: percentage of patients who developed postoperative hypoxemia (defined as PaO2/FiO2 ratio <300) (1 hour after tracheal extubation (day 1))
B: To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation (at day 28)
C: Oxygenation (PaO2/FiO2 ratio) (Up to 48 hours after extubation)
D: Oxygenation failure (2 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients
Brief Summary: In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC and venturi mask on early respiratory deterioration and patient's comfort in that setting. The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As respiratory deterioration occurs early after ICU admission, patients are randomized to receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary endpoints include comfort, dyspnea and thirst.


Options:
A: Oxygenation failure (2 hours)
B: Respiratory failure after extubation (72 hours)
C: To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation (at day 28)
D: Failure of the ventilation system (One week)

Answer: A