TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Effectiveness of Tabac Info Service (EE-TIS)
Brief Summary: Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS), was developed in France to provide an adapted web and mobile application support to smoking cessation for all adults smokers, with or without chronic diseases, who want to stop smoking. This paper presents the study protocol of the evaluation of the program. The primary objective of this evaluation is to assess the efficacy and efficacy conditions of eTIS. The secondary objectives are to 1) describe efficacy variations in regard to user characteristics, 2) analyze mechanisms and efficacy conditions of eTIS, through variations of use, social or environmental contextual factors likely to influence the efficacy of eTIS, and the behavior change techniques (BCTs).

Methods and analyses - The study design is a two-arm pragmatic randomized controlled trial including a process evaluation with at least 3000 participants randomized to the intervention or to the control arm (current practices presented in a non-interactive website). Inclusion criteria are: Adults, Smokers with an information and consent form completed, Getting a smartphone and using mobile applications, wanting stop to smoking in short, medium or long terms. The exclusion criterion is the refusal to participate in the study. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. The secondary outcomes are: the point prevalence abstinence of 24 h at 3 months later, the point prevalence abstinence of 30 days at 12 months later, number of quit attempts during the study, progression of stages within the program (changes and duration in each stage). Data will be analyzed in Intention to treat (main analyze) and per protocol ways. A logistic regression will be carried out to estimate an OR \[95% confidence interval\] for efficacy. A multivariate multilevel analysis will explore the influence of patients' characteristics, social and environmental context, conditions of use and behavior change techniques on results.

Dissemination -The findings of this study will allow us to understand and characterize the efficacy of eTIS, and conditions of its efficacy, underlining psychological, sociological, environmental and contextual factors, which could influence the efficacy of this type of intervention on smokers. These findings will be disseminated through peer-reviewed journals, national and international conference presentations and public events.


Options:
A: Point prevalence abstinence of 7 days (6 months)
B: 30 day point prevalence of abstinence (6 months)
C: Smoking abstinence (Six months post-treatment)
D: Smoking cessation (Change in smoking status from baseline at 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hydroxytyrosol and Vitamin E in the Treatment of Children With Biopsy-proven NASH
Brief Summary: Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Several studies suggest that inflammatory pathways and oxidative stress could be responsible of disease progression to non-alcoholic steatohepatitis (NASH).

Hydroxytyrosol is a simple phenolic compound naturally occurring in olive and olive oil with antioxidant properties. Some studies have demonstrated that hydroxytyrosol show several anti-inflammatory and anti-atherogenic activities, such as the inhibition of LDL oxidation and platelet aggregation.

Alpha tocopherol (Vitamin E) is the most studied anti-oxydant in pediatric NAFLD with conflicting results. It inhibits proinflammatory cytokine production and attenuates the release of profibrogenic agents and liver collagen.

The purpose of this interventional study is to evaluate the efficacy and tolerability of Hydroxytyrosol and Vitamin E in the treatment of children with biopsy-proven NASH.


Options:
A: Improvement of laboratory markers of inflammation and oxidative stress, such as concentrations of TNF-alpha, lipopolysaccharide (LPS), adiponectin, catepsin D, cytokeratin-18. (4 months); Improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile, transaminases serum levels (4 months)
B: Reduction in liver and muscle fat (4 months)
C: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
D: Biochemical: Number of Patients With Normal Transaminases at End of Treatment. (24 weeks); Physiological: Absolute Change in Liver Fat (Baseline and 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM. Background, Design and Conceptual Model of a Cluster Randomized Double-blinded Controlled Study Among Female Health Care Workers
Brief Summary: Several RCT studies have aimed to reduce either musculoskeletal disorders, sickness presenteeism, sickness absenteeism or a combination of these among females with high physical work demands. These studies have provided evidence that workplace health promotion (WHP) interventions are effective, but long-term effects are still uncertain. These studies either lack to succeed in maintaining intervention effects or lack to document if effects are maintained past a one-year period. FRIDOM (FRamed Intervention to Decrease Occupational Muscle pain) is a WHP program among health care workers. A job group characterized by having high physical work demands, musculoskeletal disorders, high sickness presenteeism - and absenteeism.

FRIDOM aimed to reduce neck and shoulder pain and secondary to reduce sickness presenteeism and sickness absenteeism. An other secondary aim was to decrease lifestyle-diseases such as other musculoskeletal disorders as well as metabolic-, and cardiovascular disorders - and to maintain participation to regular physical exercise training, after a one year intervention period. The entire concept was tailored to a population of female health care workers. This was done through a multi-component intervention including 1) intelligent physical exercise training (IPET), dietary advice and weight loss (DAW) and cognitive behavioural training (CBT).


Options:
A: Effectiveness of a worksite intervention on physical activity behavior (12 months)
B: weight loss (3 months); Weight loss (1 year)
C: Change in Body Weight (Baseline, 6 months, 12 months); Change in Waist Circumference (Baseline, 6 months,12 months)
D: Neck pain intensity as assessed by a 10 point Visual Analogue Scale (12 months follow-up); Shoulder pain intensity as assessed by a 10 point Visual Analogue Scale (12 months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Gait Pattern Analysis and Feasibility of Gait Training With a Newly Developed Walking Assist Robot in Stroke Patients and Elderly Adults
Brief Summary: The purpose of this study was to investigate the effects of the new wearable hip assist robot developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) to gait rehabilitation in elderly adults and stroke patients.


Options:
A: Change From Baseline in Berg Balance Scale at 4 Weeks (Baseline and 4 weeks from baseline)
B: Change in 10 meter walk test from baseline in gait speed (session 0 (initial visit); session 11 (at approximately 4 weeks))
C: Motricity Index (Six months)
D: Walking ability - Functional Ambulation Category (Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioural Activation Treatment for Smoking Cessation and Depressive Symptomatology: a Randomized Controlled Trial
Brief Summary: The number of people who smoke, have concurrent depression and that seek treatment for smoking cessation has increased in recent years. This implies the need to design intensive and specific interventions that target this issue. In depression treatment, behavioural activation is one of the psychological interventions whose characteristics of brevity, flexibility and efficiency make it an ideal candidate to be included as part of smoking cessation treatment, especially when smokers have depressive symptoms. The aims of the present trial are: 1) to assess the efficacy (abstinence rates) of a psychological smoking cessation treatment with elements from behavioural activation for managing depressed mood (a randomized control trial with three groups: standard cognitive-behavioural smoking cessation treatment, standard cognitive-behavioural smoking cessation treatment plus behavioural activation, and a control group of delayed treatment) at the end of treatment, and at 3-, 6-, and 12-months follow-ups; and 2) to assess whether the applied cognitive-behavioural smoking cessation treatment plus behavioural activation improves depressed mood at the end of treatment and 3-, 6, 12-months follow-ups.


Options:
A: To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD (5 years)
B: Plasma Cotinine Concentration (Measured at the end of the last 3 weeks of randomization trial phase)
C: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)
D: Point-prevalence abstinence (1 year); Change from baseline in depressive symptoms on the Beck Depression Inventory-II (BDI-II) (1 year); Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Observational Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program
Brief Summary: The purpose of this study is to conduct an observational assessment of natural outcomes within the Duke Smoking Cessation Program (DSCP), "Quit at Duke." This assessment will include information regarding abstinence rates, changes in patient emotional state following treatment, and costs of operations. Primarily, this study will assess the financial sustainability and the cost-effectiveness of the program.


Options:
A: Smoking Abstinence (12 months)
B: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
C: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
D: tobacco related knowledge post program (at the end of the program (+ 1 DAY POST THE PROGRAM)); tobacco cessation related skills difference between the 2 groups (at the end of the program (+ 1 DAY AFTER THE PROGRAM))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Observational Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program
Brief Summary: The purpose of this study is to conduct an observational assessment of natural outcomes within the Duke Smoking Cessation Program (DSCP), "Quit at Duke." This assessment will include information regarding abstinence rates, changes in patient emotional state following treatment, and costs of operations. Primarily, this study will assess the financial sustainability and the cost-effectiveness of the program.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: Prolonged Abstinence (Weeks 7-10)
C: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)
D: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Observational Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program
Brief Summary: The purpose of this study is to conduct an observational assessment of natural outcomes within the Duke Smoking Cessation Program (DSCP), "Quit at Duke." This assessment will include information regarding abstinence rates, changes in patient emotional state following treatment, and costs of operations. Primarily, this study will assess the financial sustainability and the cost-effectiveness of the program.


Options:
A: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
B: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
C: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
D: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Observational Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program
Brief Summary: The purpose of this study is to conduct an observational assessment of natural outcomes within the Duke Smoking Cessation Program (DSCP), "Quit at Duke." This assessment will include information regarding abstinence rates, changes in patient emotional state following treatment, and costs of operations. Primarily, this study will assess the financial sustainability and the cost-effectiveness of the program.


Options:
A: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)
B: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
C: smoking cessation: 7-day point prevalence abstinence (6 months)
D: Point prevalence abstinence at 6 months (6 months after beginning treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improvement of Acute Pain Treatment With Systemic and Regional Anesthesia
Brief Summary: The German Network for acute pain management and Regional Anesthesia (NRA) is a multi-center, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported procedural and outcome data of systemic analgesia and regional anesthesia hosted by the German Society of Anesthesia and Intensive Care Medicine (DGAI) and professional Society German Anesthetists (BDA)


Options:
A: Pain scores at rest (45 minutes after the injection)
B: Consumption of opioids
C: Respiratory complications (During hospital stay, up to 1 month)
D: Acute complications during insertion of regional anesthesia (at the day of insertion, day zero)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)
Brief Summary: The purpose of this study is to evaluate three pharmacist-outreach strategies for improving adherence to insulin among individuals with diabetes. The three approaches are equivalently-priced but vary by degree of targeting and intervention intensity.


Options:
A: Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale (Baseline and 1 year); Changes in Minutes of Moderate Physical Activity (Baseline and 1 year); Changes in Minutes of Vigorous Exercise (Baseline and 1 year)
B: Change in Glycemic Control (HbA1c) (6 months (baseline to 6 months))
C: Insulin Persistence (From 1 month (30 days) after randomization through 12 months (365 days) after randomization)
D: Number of patients with hypoglycaemia in usual care versus telemedicine during Ramadan (Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Adjunctive Use of Vaginal Progesterone After Cerclage on Prevention of 2nd Trimester Miscarriage
Brief Summary: Pregnancy loss in the second trimester is not uncommon. About 2-3% of pregnancies will be lost in the second trimester, which is much lower than in the first trimester. Once a pregnancy reaches 20 weeks gestation, less than 0.5% will end in a fetal demise.

Congenital fetal abnormalities and maternal anatomic factors as immunologic factors, infection, and thrombophilia should be considered; however, a reason and its result connection may be difficult to be established.

Cervical incompetence means that the cervix is weak and unable to remain closed during the pregnancy. While cerclage may provide a degree of support to a 'weak' cervix, its role in maintaining the cervical length and the endocervical mucus plug as a mechanical barrier to ascending infection may be more important.

Cervical cerclage is performed usually in women with a history of mid-trimester abortion or spontaneous preterm birth due to cervical 'incompetence', with the aim of preventing recurrent loss.

Cerclage is a commonly performed as a prophylactic intervention used by most obstetricians despite the absence of a well-defined population for whom there is clear evidence of benefit. Furthermore, there is little consensus on the optimal cerclage technique and timing and type of suture placement.

The Progesterone is known to have an inhibitory action on uterine contractility and is thought to play a main role in the maintenance of pregnancy until term. Progesterone is also able to modify the ultrastructural organisation of the myometrium by inhibiting the gap junctions, and preventing muscular contraction.

Different routes of administration of progesterone have been described in the literature. These include weekly intramuscular injections from 16 to 20 weeks through to 36 weeks and daily vaginal progesterone suppositories from 24 weeks to 34 weeks of gestation.

A recently published Cochrane review further confirmed the beneficial effects of progesterone in infant health following administration in women considered to be at increased risk of preterm birth due either to past history of preterm birth or when a short cervix was identified on ultrasound.

However; most of these published studies have been conducted to test the effect of progestational agents for the prevention of preterm labor not miscarriage.

Doppler ultrasonography is use to evaluate blood flow. In the field of perinatology, Doppler ultrasonography has been used to assess fetal well-being, especially in intra-uterine growth retardation and fetal anemia, and it plays an important role in managing of these conditions


Options:
A: The frequency of spontaneous abortion before 28 weeks (14 weeks)
B: Delivery before than 37 weeks gestation (Up to 37 weeks gestation)
C: Gestational age of delivery (<37 weeks)
D: Spontaneous delivery before 34 completed weeks (238 days) of gestation.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Adjunctive Use of Vaginal Progesterone After Cerclage on Prevention of 2nd Trimester Miscarriage
Brief Summary: Pregnancy loss in the second trimester is not uncommon. About 2-3% of pregnancies will be lost in the second trimester, which is much lower than in the first trimester. Once a pregnancy reaches 20 weeks gestation, less than 0.5% will end in a fetal demise.

Congenital fetal abnormalities and maternal anatomic factors as immunologic factors, infection, and thrombophilia should be considered; however, a reason and its result connection may be difficult to be established.

Cervical incompetence means that the cervix is weak and unable to remain closed during the pregnancy. While cerclage may provide a degree of support to a 'weak' cervix, its role in maintaining the cervical length and the endocervical mucus plug as a mechanical barrier to ascending infection may be more important.

Cervical cerclage is performed usually in women with a history of mid-trimester abortion or spontaneous preterm birth due to cervical 'incompetence', with the aim of preventing recurrent loss.

Cerclage is a commonly performed as a prophylactic intervention used by most obstetricians despite the absence of a well-defined population for whom there is clear evidence of benefit. Furthermore, there is little consensus on the optimal cerclage technique and timing and type of suture placement.

The Progesterone is known to have an inhibitory action on uterine contractility and is thought to play a main role in the maintenance of pregnancy until term. Progesterone is also able to modify the ultrastructural organisation of the myometrium by inhibiting the gap junctions, and preventing muscular contraction.

Different routes of administration of progesterone have been described in the literature. These include weekly intramuscular injections from 16 to 20 weeks through to 36 weeks and daily vaginal progesterone suppositories from 24 weeks to 34 weeks of gestation.

A recently published Cochrane review further confirmed the beneficial effects of progesterone in infant health following administration in women considered to be at increased risk of preterm birth due either to past history of preterm birth or when a short cervix was identified on ultrasound.

However; most of these published studies have been conducted to test the effect of progestational agents for the prevention of preterm labor not miscarriage.

Doppler ultrasonography is use to evaluate blood flow. In the field of perinatology, Doppler ultrasonography has been used to assess fetal well-being, especially in intra-uterine growth retardation and fetal anemia, and it plays an important role in managing of these conditions


Options:
A: Ongoing pregnancy rate (12 weeks)
B: The chance of miscarriage before 20 weeks of gestation (At 20 weeks of gestation)
C: The frequency of spontaneous abortion before 28 weeks (14 weeks)
D: Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination (T1 (20 days); T2 (40 days))

Answer: C