TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Dabigatran Following Transient Ischemic Attack and Minor Stroke
Brief Summary: Rationale: To date, anticoagulant therapy in acute stroke has also been limited by excess hemorrhagic events. The oral anticoagulant dabigatran is a novel agent, which has been shown to be associated with much lower intracranial hemorrhage rates. It has been suggested that this agent may provide the superior benefits of anticoagulation in acute stroke, without the concomitant increase in hemorrhage risk associated with heparin/LMWH or warfarin.

Study Design: DATAS II is a randomized, open label blinded endpoint trial. Participants (n=300) with TIA or ischemic stroke (NIHSS score \<9) will be enrolled within 48 hours of symptom onset from approximately four (4) health care centres across Canada. All participants will have an MRI with DWI lesion volume \< 25 ml. Participants will be randomized 1:1 to treatment with dabigatran for 30 days or ASA 81 mg daily (current standard of care). All stroke patients will initially be screened with a non-contrast CT scan of the brain. The first MRI will be performed within 48 hours of symptom onset. Imaging studies will be repeated at day 30. All patients will be assessed clinically at Day 30 and Day 90.

Study Aims:

1. Establish the safety of early anticoagulation with the novel oral anticoagulant dabigatran in acute cerebrovascular syndrome patients.
2. Identify the rate of both symptomatic and asymptomatic hemorrhagic transformation (HT) associated with these treatments.
3. Identify predictors of HT associated with acute dabigatran treatment.

Hypothesis: The Investigators hypothesize that symptomatic HT rates in dabigatran and ASA treated patients will not be significantly different.

Study outcomes: The primary outcome is the rate of symptomatic hemorrhagic transformation (HT), defined as a parenchymal hematoma, which is \>30% of the infarcted area on DWI, with substantial space- occupying effect, associated with clinical worsening (≥4 point increase in National Institutes of Health Stroke Scale (NIHSS) score) within 5 weeks of treatment initiation. The major secondary outcome the rate of asymtomatic HT see on day 30 MRI sequence.


Options:
A: Rate of symptomatic hemorrhagic transformation (within 5 weeks of treatment initiation)
B: Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA (180 days)
C: Composite of Subsequent Stroke or Death (From randomisation (day 1) to visit 3 (day 30-34))
D: Safety of nadroparine or heparin (DAY 3,7,30,90); Efficacy of nadroparine or heparin (DAY 3,7, 30, 90)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.
Brief Summary: To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer


Options:
A: To compare ZD1839 and vinorelbine in terms of progression free survival
B: Progression Free Survival (12 months)
C: Median Progression Free Survival (PFS) (Months) (At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression); Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months (At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression)
D: Progression Free-survival (From the date of randomization to the date of last follow up, assessed up to 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]
Brief Summary: The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.


Options:
A: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks (Week 8)
B: Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12)
C: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks (Baseline and Weeks 2 to 52)
D: Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period. (From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effective Surveillance and Impact of HPV Vaccination on Screening for Cervical Cancer in Tuscany
Brief Summary: The purposes of this study are to evaluate the effectiveness of vaccination in 25-year old women at the time of their first access to cervical cancer screening, to understand the impact of vaccination on screening activity; to evaluate the immune response following vaccination; to study the dynamics of the infection after vaccination, including the possible change in the frequency of non-vaccine HPV types, to evaluate cytological abnormalities reductions in vaccinated women and to assess if HPV test in urine sample could be a useful non-invasive method to monitor HPV status in younger women.


Options:
A: To determine the HPV-type specific antibody levels at 2, 3.5, and 5 years after completion of the QHPV vaccine schedule for each of the arms in P1047 (208 weeks (4 Years))
B: number of HR-HPV infections and number of infections due to HPV vaccine types in cervical sample in the Experimental arm and in No intervention arm (30 months); number of cytological abnormalities in the Experimental arm and in No intervention arm (30 months)
C: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)
D: Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. (25 months); Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. (25 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The C-MAC Videolaryngoscope Compared With Conventional Laryngoscopy for Rapid Sequence Intubation at the Emergency Department
Brief Summary: All patients undergoing emergent endotracheal intubation (RSI) at the Emergency Department will be screened for inclusion in this clinical study. The indication of endotracheal intubation is an exclusively clinical decision and is not affected by this study protocol in any aspect.

If fulfilling the In- and exclusion criteria's, patient will be randomly assigned to one of two groups

1. C-MAC Videolaryngoscope in appropriate size
2. conventional endotracheal intubation using Macintosh Blade in appropriate size

Randomization (1:1) will be based on computer-generated codes maintained in sequentially numbered opaque envelopes that will be opened immediately before randomization.


Options:
A: intubation success (at intubation; < 120 seconds)
B: Classification of Glottis Visualization (At intubation)
C: Success Rate (10 minutes)
D: Proportion of successful orotracheal intubation at first laryngoscopy (intubation procedure, an expected average of 15 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Multicenter Cohort Study to Evaluate the Benefit of the Geriatric Fracture Center (GFC) Concept
Brief Summary: The study will assess patients with at least one major AE related to treatment / hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to the usual care group.


Options:
A: Relational Coordination (For average period of 3 months)
B: Major Adverse Events related to treatment / residential status / immobilization (From surgery up to 1 year follow-up)
C: functional recovery (baseline, end of nursing home admission)
D: Mortality (6 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Test and Treat TB: A Proof of Concept Trial in South Africa
Brief Summary: The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of a "Test \& Treat TB" strategy on a mobile HIV screening unit in South Africa and (2) to assess the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy for maximizing linkage to TB care and treatment completion.


Options:
A: Number of patients who complete tuberculosis treatment (6 months)
B: Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy (2 months)
C: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases (2 months after enrollment)
D: Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. (Two years); Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART. (Three years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure: A Randomized Controlled Trial
Brief Summary: Aims: Advance care planning (ACP) is considered to be one of the most promising interventions to enable patients with life limiting illnesses to receive treatment at the end of life (EOL) according to their own preferences and to promote EOL conversations between patients and their health care providers. Through a 2-arm randomized controlled trial (RCT) of patients with Class III and IV heart failure (New York Heart Association Functional Classification), we propose to assess:

1. Whether patients in the ACP arm have a greater likelihood of receiving EOL care consistent with their preferences as stated in the latter of the last ACP document or the last patient interview, compared to patients in the control arm.
2. Heath care costs during study duration between patients in ACP and control arms.
3. Patient's understanding of own illness and their participation in decision making between the ACP and control arms.
4. Patient's quality of life, anxiety and depression between ACP and control arms.

Methodology: A total of 254 patients with advance heart failure will be randomized to receive intervention (ACP arm; N=127) or usual care (control arm; N=127).

The RCT will be conducted at the National Heart Centre and Singapore General Hospital. Patients in both arms will be followed for one year or till death, whichever is earlier, and interviewed every 4 months during this duration.

Clinical Significance: If benefits of ACP are shown to add value through this trial, then this study will help to promote acceptance of ACP among patients and health care providers across Singapore and elsewhere.


Options:
A: changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks (baseline and after 4, 16 and 24 weeks)
B: Proportion of patients receiving end of life care consistent with their stated preferences (one year)
C: Is there a change in patient understanding of prognosis with the addition of a palliative care intervention? (6 months)
D: The proportion of patients who had their preferences regarding place of care and place of death met (1.7.2015)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing the Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of a Semi-Quantitative Pregnancy Test for At-Home Follow-Up
Brief Summary: This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and acceptability of two medical abortion regimens that are commonly used in Latin America. The first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in three hour intervals. This study will also aim to assess the feasibility and acceptability of a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.


Options:
A: Number of surgical evacuation in each group (during de study)
B: Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion (7-36 days)
C: Ongoing pregnancy rates (1-2 weeks)
D: complete abortion rate (5 weeks after treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial
Brief Summary: The primary objective of this study is to assess the efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk.


Options:
A: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)
B: Suicidal Attempts (Months 1, 3, 6, 12, 18, and 24)
C: Social Processing (Cyberball) fMRI Task: fMRI Responses (Pre-treatment (baseline) and post-treatment (up to 2 weeks)); Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 1 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Ecological Momentary Assessment (EMA): NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 2 (pre-treatment (baseline) and post-treatment (up to 2 weeks)); Self Injurious Thoughts and Behaviors Inventory Part 3 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Self Injurious Thoughts and Behaviors Inventory Part 4 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline))
D: BSSI score (Day 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial
Brief Summary: The primary objective of this study is to assess the efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk.


Options:
A: Suicide Attempt Self Injury Interview SASII (up to 12th months)
B: BSSI score (Day 3)
C: Repeat Suicide Attempts (1, 2, and 3 months)
D: Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment (16 weeks (end of treatment)); Change in the Severity of Depression Symptoms Between Intake and End of Treatment (16 weeks (end of treatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial
Brief Summary: The primary objective of this study is to assess the efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk.


Options:
A: BSSI score (Day 3)
B: Change in Beck Scale for Suicide Ideation Score (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Suicide Attempt Index (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Index of Spouse Abuse Score (Baseline, Week 10, Post-treatment Months 6 and 12)
C: Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task (At 2 weeks after group completion); Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task (At 2 weeks after group completion); Baseline activation when viewing angry vs. neutral faces during an implicit emotional visualization task (At 3 months after therapy)
D: Change in Beck Scale for Suicide Ideation (BSS) score (Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study investigates the effect of varying both energy density and portion size of all foods at lunch on preschool children's intake. The foods used in this study are commercially-available, commonly-consumed foods with typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of energy density and portion size on preschool children's intake at a meal composed of foods typically served to this population.


Options:
A: BMI variation from baseline (12 months)
B: Food and energy intake (Food weight (grams) and energy (kcal) (Once a week for four weeks)
C: Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses (At lab visit)
D: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study investigates the effect of varying both energy density and portion size of all foods at lunch on preschool children's intake. The foods used in this study are commercially-available, commonly-consumed foods with typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of energy density and portion size on preschool children's intake at a meal composed of foods typically served to this population.


Options:
A: Vegetable Intake in Preschool Children (1 year 11 months)
B: BMI z-score (via measured weight and height) of preschooler (~2 years post baseline)
C: Food and energy intake (Food weight (grams) and energy (kcal) (Once a week for four weeks)
D: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study investigates the effect of varying both energy density and portion size of all foods at lunch on preschool children's intake. The foods used in this study are commercially-available, commonly-consumed foods with typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of energy density and portion size on preschool children's intake at a meal composed of foods typically served to this population.


Options:
A: Change in Child Body Mass Index (BMI Z-score) (Change from Baseline at 12 and 21 months)
B: Change in glycemic control, change in dietary intake (18 months)
C: Food and energy intake (Food weight (grams) and energy (kcal) (Once a week for four weeks)
D: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
Brief Summary: This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.


Options:
A: Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) (8 weeks after last assigned study treatment)
B: Proportion of patients without recurrent CDI (12 weeks after treatment)
C: Cure of C. difficile infection (8 weeks)
D: Clinical Cure (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physsurg - a Controlled Randomized Trial on the Effect of Physical Activity in Relation to Outcome After Surgery
Brief Summary: This study will compare the outcome after surgery between a group of patients that receives instructions for prehabilitation training and one group that received standard treatment.


Options:
A: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)
B: 6 minute walk test (6MWT) (up to 8 weeks after surgery)
C: Post operative complications (30 days after surgery)
D: 6-minute-walking-distance (6MWD) (4 weeks postoperatively)

Answer: A