TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentric Randomized Clinical Trial to Evaluate the Long-term Effectiveness of a Motivational Intervention Against Smoking, Based on the Information Obtained From Spirometry in Primary Care.
Brief Summary: There is controversy about the effectiveness of interventions based on spirometry for smoking cessation.

The investigators want to evaluate the effectiveness of motivational intervention performed by a doctor to obtain abstinence compared with normal practice in primary care.

This study, is the second half of what was began with ESPITAP study


Options:
A: Motivation to quit smoking, utilization of available resources, smoking cessation rate (1 year)
B: smoking abstinence: self reported abstinence (12 or more months) (12 months)
C: Number of subjects versus controls who are non-smokers at 4 weeks and six months after completion of smoking cessation clinic (Nine months (from recruitment to completion))
D: Cessation of tobacco consumption at 12 months. (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot, Double-blind, Placebo-controlled, 2-period Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this study is to assess the effect of aclidinium bromide compared with placebo in improving dilatation of the airways (bronchodilation), symptoms of chronic obstructive pulmonary disease (COPD), sleep quality and physical activity after 3 weeks of treatment with aclidinium bromide 400 μg administered twice daily in patients with stable moderate-and-severe COPD.


Options:
A: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)
B: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-24hr (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment)
C: Change in 6-Minute Walk Test Distance (6MWT) (baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
D: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) - Phase 1 Clinical Trial
Brief Summary: The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care.


Options:
A: Reaching (Toy Contact Duration) (1 month post intervention); Early Problem Solving Indicator (EPSI) (End of intervention, 1 and 3 months post intervention)
B: Bonding between primary caregiver and infant (6 months)
C: neurodevelopmental outcome (one year corrected age)
D: Fidgety Movements at 12 weeks (post-term age) (12 weeks post-term age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Recalibrating Intestinal Microflora in IBS by Fecal Transplantation
Brief Summary: Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial - the REFIT project

Irritable bowel syndrome (IBS) is a condition characterized by variable complaints like diarrhoea, bloating and abdominal pain, and may result in considerably reduced quality of life and increased sickness absence. The prevalence of IBS in the general population may be as high as 15 per cent depending on the diagnostic criteria used. The pathophysiology of IBS is poorly understood and theories of visceral hypersensitivity, micro-inflammation and other less well founded theories have been stated. So far, no measurement or test can affirm diagnosis, but exclusion of organic diseases in combination with a typical symptom pattern according to the Rome classification can set the diagnosis.

Earlier non-controlled case reports have shown a convincing effect of fecal microbial transplantation (FMT) in IBS patients. However, no placebo controlled trial has been performed in this condition. Changes in the gut microbiome may be an important factor in IBS pathogenesis. Microbiome analysis has revealed changes in microbiome composition that may trigger changes in visceral sensibility and pain perception.

The fecal microbial transplantation (FMT) procedure has been used primarily to treat clostridium difficile infections. Few minor side effects have been reported.

Hypothesis: IBS is caused by an imbalance of the gut microbiome that may be reset by transplanting a microbiome sample from a healthy donor.

Aim of study:

* To test the clinical effect of FMT in patients with IBS
* To describe the fecal microbiome in IBS patients
* To describe changes in the fecal microbiome of IBS patients following FMT

The REFIT study will perform a randomized placebo-controlled double blinded trial of FMT on IBS according to the Rome 3 criteria. A study group of 60 IBS (diarrhoea variant) patients will recruited from general practice and allocated to active (30) or placebo (30) by block randomization. Donors will be 15 healthy volunteers with no risk behaviour and a pre-screening for communicable diseases will be performed.

Outcome measures will be clinical assessment by IBS-severity scoring system (IBS-SSS) at 0, 1, 3, 6, and 12 months. Microbiome analysis will be performed by metagenomic sequencing (University of Tromsø) at 0, 3, and 12 months for patients, and at inclusion for donors.


Options:
A: Safety (up to 6 mo post FMT)
B: Change in subjective symptom score (at 0 and 3 months)
C: Clinical Cure (8 weeks)
D: Proportion of patients without recurrent CDI (12 weeks after treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Injectable Intracervical Anesthesia on the Pain Associated With the Insertion of the Levonorgestrel-releasing Intrauterine System in Women Without Previous Vaginal Delivery: a Randomized Controlled Trial
Brief Summary: This study has the objective to evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous vaginal delivery.

H0: There is no difference in terms of pain score between the treatments H1: There will be difference in terms of pain score between treatments


Options:
A: Pain During IUD Insertion at Various Time Points (See Description for Time Points) (During IUD insertion (see above description for which time points))
B: Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale (assessed immediately post IUD insertion)
C: Mean Maximum Procedural Pain Scores (2 minutes after the procedure.)
D: Pain (immediately after LNG-IUS insertion (approx 1 sec))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients With Moderate to Very Severe COPD With Previous Exacerbations.
Brief Summary: The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.


Options:
A: Identifying new patient subtypes and endpoints for COPD (3 years)
B: Rate of Moderate or Severe Exacerbations (From randomization to Week 52)
C: Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL (Immediately following the first IP dose through week 56)
D: Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants (Week 1 up to Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Case Management for Underserved Hispanic Type 2 Diabetes Populations
Brief Summary: To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard.


Options:
A: Clinical inertia (12 month post intervention)
B: Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg (4 months)
C: HbA1c (6 months)
D: Hemoglobin A1c (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Case Management for Underserved Hispanic Type 2 Diabetes Populations
Brief Summary: To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard.


Options:
A: Proportion of older ED patients who receive a potentially inappropriate medication (During discharge home from the ED)
B: HbA1c (6 months)
C: Enhanced goal-consistent care (up to 2 years); PEACE (up to 2 years)
D: Rate of initiation of adequate measures to prevent stroke (oral anticoagulant prescription) by physician in charge (End of hospital stay (expected average duration of 1 week))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Case Management for Underserved Hispanic Type 2 Diabetes Populations
Brief Summary: To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard.


Options:
A: HbA1c (6 months)
B: Blood glucose control (hemoglobin AIc) (Baseline, and 3 follow ups (mos 4, 8, 12))
C: Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 (Baseline, Month 12)
D: Diet. Starting the Conversation is a 9 items measure of eating patterns (including 2 items from the NCI Fruit and Vegetable Screener). NCI Percent Energy from Fat Screen (PFAT) contains 17 items concerning frequency of intake for 15 food groups. (Baseline, 16 weeks, and 12 months); Physical Activity. The CHAMPS (28 items) will be used to measure physical activity. (Baseline, 16 weeks, and 12 months); Medication Adherence. Medication taking will be assessed by the Hill-Bone Medication Adherence scale. Questions will also cover smoking and alcohol use. (Baseline, 16 weeks, and 12 months); Distress. Patient distress will be assessed across several measures including: the 20-item CES-D, the 17-item DDS, the PHQ8, and screening items from the SCID to rule out psychosis. (Baseline, 16 weeks, and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Sham-controlled, Randomized Clinical Trial on Stroke Treatment Using Transcranial Direct Current Stimulation
Brief Summary: The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke


Options:
A: Fugl-Meyer Assessment score (2 months post-stimulation)
B: Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) (6 weeks)
C: Functional Independence measured by Barthel Index (Change for functional independence at 4 months)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Sham-controlled, Randomized Clinical Trial on Stroke Treatment Using Transcranial Direct Current Stimulation
Brief Summary: The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke


Options:
A: Fugl-Meyer Assessment (FMA) (At baseline and immediately after the completion of intervention); Motor Status Scale (MSS) (At baseline and immediately after the completion of intervention); Modified Ashworth Scale (MAS) (At baseline and immediately after the completion of intervention); MyotonPRO (At baseline and immediately after the completion of intervention); Muscle metabolism (NIRS) (At baseline and immediately after the completion of intervention); Box and Block Test (BBT) (At baseline and immediately after the completion of intervention); Revised Nottingham Sensory Assessment (RNSA) (At baseline and immediately after the completion of intervention); Functional Independence Measure (FIM) (At baseline and immediately after the completion of intervention); Motor Activity Log (MAL) (At baseline, immediately after the completion of intervention, at a 6-month follow up); ABILHAND Questionnaire (At baseline, immediately after the completion of intervention, at a 6-month follow up); Adelaide Activities Profile (AAP) (At baseline, immediately after the completion of intervention, at a 6-month follow up); EQ-5D-5L (At baseline and immediately after the completion of intervention); Accelerometers (At baseline, immediately after the completion of intervention, at a 6-month follow-up.); Functional magnetic resonance imaging (fMRI) (At baseline and immediately after the completion of intervention); Kinematic analysis (At baseline and immediately after the completion of intervention); Inflammatory markers (At baseline and immediately after the completion of intervention); Oxidative stress markers (At baseline and immediately after the completion of intervention); Erythrocyte deformability (At baseline and immediately after the completion of intervention); Blood glucose indicators (At baseline and immediately after the completion of intervention)
B: Functional Independence measured by Barthel Index (Change for functional independence at 4 months)
C: Jebsen Taylor test (5-15-30 days)
D: electromyography (EMG ) activity of Tibialis Anterior Muscle. (1 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Sham-controlled, Randomized Clinical Trial on Stroke Treatment Using Transcranial Direct Current Stimulation
Brief Summary: The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke


Options:
A: Upper Extremity Fugl-Meyer (2 weeks); Upper Extremity Fugl-Meyer (3 months); Upper Extremity Fugl-Meyer (1 year after stroke)
B: Fugl-Meyer Upper Extremity (A week prior to treatment beginning)
C: Functional Independence measured by Barthel Index (Change for functional independence at 4 months)
D: Jebsen Taylor test (5-15-30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Clinical Trial Comparing Rivaroxaban vs Warfarin in High Risk Patients With Antiphospholipid Syndrome
Brief Summary: Primary Study Objective(s) The primary objective is to demonstrate the non-inferiority of Rivaroxaban 20 mg (or 15mgqd in case of moderate renal insufficiency) versus warfarin (INR 2.0-3.0) with respect to the occurrence of the cumulative end point of incident acute thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleedings, and death in triple aPL-positive APS patients.

Study Design A multicentre, interventional, prospective, parallel, randomised, controlled, open-label, Rivaroxaban 20 mg qd (or 15mg qd in patients with moderate renal insufficiency) vs warfarin (INR target 2.5), non-inferiority study, in 535 triple aPL-positive APS patients in approximately 40 Internal Medicine and Thrombosis centres. Each local Institutional Review Board will approve the study.

Study Population Patients of both sexes, of age 18-75, affected by anti-phospholipid syndrome, with a high probability of recurrences as defined by triple aPL-positivity, are eligible for this study.

Primary Outcome variables The primary cumulative outcome measure will be incident acute thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or death.

Secondary Outcome variables Separate evaluation of arterial and venous thrombosis and all-cause death.

04.27.2015: An amendment has been made. Enrollment permitted till 75 years of age.


Options:
A: Successful pregnancy outcome
B: Cumulative outcome measure will be incident acute thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or death. (up to 4 years)
C: Live Birth (after delivery)
D: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-month Multicenter Randomized Trial to Evaluate the Efficacy of a Physical Activity Promotion Program on the Experience of Physical Activity in Patients With COPD (Mr PAPP)
Brief Summary: The purpose of this 3 month randomized intervention study is to investigate the additional effect of a physical activity telecoaching program on physical activity in patients with COPD, compared with usual care.


Options:
A: Daily step count (90 days)
B: Daily number of steps (changes from baseline to 3 months)
C: Combined number of hospitalizations and emergency department presentations (Two years)
D: Total cost of hospitalization, $ (Day of admission to day of discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-month Multicenter Randomized Trial to Evaluate the Efficacy of a Physical Activity Promotion Program on the Experience of Physical Activity in Patients With COPD (Mr PAPP)
Brief Summary: The purpose of this 3 month randomized intervention study is to investigate the additional effect of a physical activity telecoaching program on physical activity in patients with COPD, compared with usual care.


Options:
A: Number of unscheduled hospital days (up to 12 months)
B: Re-hospitalization (90 days)
C: disease-specific health-related quality of life (HRQoL) (two years)
D: Daily number of steps (changes from baseline to 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-month Multicenter Randomized Trial to Evaluate the Efficacy of a Physical Activity Promotion Program on the Experience of Physical Activity in Patients With COPD (Mr PAPP)
Brief Summary: The purpose of this 3 month randomized intervention study is to investigate the additional effect of a physical activity telecoaching program on physical activity in patients with COPD, compared with usual care.


Options:
A: 6 minute walk test (measured at week 8)
B: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
C: Re-hospitalizations (During the 30days after discharge)
D: Daily number of steps (changes from baseline to 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-month Multicenter Randomized Trial to Evaluate the Efficacy of a Physical Activity Promotion Program on the Experience of Physical Activity in Patients With COPD (Mr PAPP)
Brief Summary: The purpose of this 3 month randomized intervention study is to investigate the additional effect of a physical activity telecoaching program on physical activity in patients with COPD, compared with usual care.


Options:
A: Number of hospitalizations due to exacerbation of COPD avoided (1 year)
B: Change in physical activity (Baseline and 12 months follow-up)
C: Daily number of steps (changes from baseline to 3 months)
D: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-month Multicenter Randomized Trial to Evaluate the Efficacy of a Physical Activity Promotion Program on the Experience of Physical Activity in Patients With COPD (Mr PAPP)
Brief Summary: The purpose of this 3 month randomized intervention study is to investigate the additional effect of a physical activity telecoaching program on physical activity in patients with COPD, compared with usual care.


Options:
A: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)
B: Number of hospital admissions for exacerbations of COPD
C: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
D: Daily number of steps (changes from baseline to 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 3-month Multicenter Randomized Trial to Evaluate the Efficacy of a Physical Activity Promotion Program on the Experience of Physical Activity in Patients With COPD (Mr PAPP)
Brief Summary: The purpose of this 3 month randomized intervention study is to investigate the additional effect of a physical activity telecoaching program on physical activity in patients with COPD, compared with usual care.


Options:
A: Daily number of steps (changes from baseline to 3 months)
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: Number of hospitalizations due to exacerbation of COPD avoided (1 year)
D: Measure of physical activity (Change from Baseline to Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Beyond Silence: Comparing the Impact of Contact-based Education With Mental Health Literacy Training on Early Intervention for Healthcare Workers With Mental Health Issues
Brief Summary: The purpose of this study is to compare the impact of a new workplace-based mental health peer education program with standardized mental health literacy training on early intervention and support for healthcare employees with mental health issues. Participants are healthcare workers who volunteer to participate in one of the two twelve-hour group education programs. It is hypothesized that the customized "Beyond Silence" peer education program led by trained staff members with personal experience of mental ill-health will be more effective in reducing the stigma associated with help-seeking and help-outreach regarding mental ill-health in the workplace. The comparison group is a standardized mental health literacy training program that has been widely implemented in both Canada and around the world. Change in help-seeking/help-outreach behavior, mental health knowledge and beliefs of participants will be assessed at three-month intervals; before, after and three months following the educational intervention.


Options:
A: Increased confidence in help-giving behaviour as measured by comparing the intervention group after having attended the training course with the control group. (questionnaire) (6 months)
B: Change in Employees' help-seeking behaviour (6, 12 and 24 months.)
C: Changes in mental health service utilization (baseline, 2 months)
D: Change from baseline in help-seeking behavior (Baseline, post-intervention, 3 month follow-up); Change from baseline in help-outreach behavior (Baseline, post-intervention, 3 month follow-up)

Answer: D