TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: "Comparison of Vaginal Progesterone With Arabin Cervical Pessary and Vaginal Progesterone Alone in the Prevention of Preterm Delivery in Singleton Pregnancies With Incidental Premature Shortening of Cervical Length"
Brief Summary: 1. This will be a randomized prospective and open-label study with no placebo control or blinding of the participants and the research team members. The study is to compare the effectiveness of vaginal progesterone versus combination of vaginal progesterone and Arabin cervical pessary in the prevention of preterm delivery among patients with incidental shortened cervical length.
2. As part of standard clinical care, all pregnant patients usually have cervical length measurements at the mid-trimester during the anatomy scan from 18 to 24 weeks with the GE ultrasound Volusion 8 using the vaginal probe.

   1. Patients with short cervix will be counseled and offered the opportunity to participate in the study.
   2. All participants will be taught how to use the vaginal progesterone once daily prior to bedtime. In addition, those in the combination group will have the cervical pessary placed in the clinic right away or within a week if they request for more time to brood over their diagnosis and weigh on the option of inserting Arabin pessary.
   3. All participants will be followed up in the high-risk obstetric clinic as per standard prenatal care. Frequency of follow up visits will be individualized depending on patient's need and comorbidities. , Participants will be requested to bring the remnant of the vaginal progesterone to the clinic to assess compliance.
   4. Participants in the study will continue their prenatal care with UIC high-risk obstetric clinic until delivery.
   5. The study recruitment will occur for a period of 2 years starting from November 2016 to October 2018 or until all the anticipated numbers of study subjects have been attained.
   6. There will be 10 % over-sampling to cater for those who will drop out from the study or loss to follow up after randomization, and those who delivered in another hospital.
   7. Participants will have access to one of the investigators or the high- risk clinic nurse for any complaints related to their conditions.
   8. Participants can opt out at any stage of the study if they do not want to continue further or if there are any adverse effects.


Options:
A: Recruitment feasibility (Up to 24 weeks (18 to 42 weeks of gestation))
B: Children's survival without neurodevelopmental disability at the age of 3 years (assessment of the newborn at age of 3 years (corrected age for prematurity))
C: preterm birth before 34 weeks of gestation rate in singleton pregnancies (up to 20 weeks from recruitment); preterm birth before 32 weeks of gestation rate in twin pregnancies (up to 20 weeks from recruitment)
D: Preterm delivery before 37 weeks (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation and Validation of a New Questionnaire to Identify and Quantify Abdominal Symptoms in Patients With Cystic Fibrosis Following FDA Guidelines: the CF Abd-Score (Primarily Named JenAbdomen-CF Score)
Brief Summary: Development, validation and evaluation of a new multimodal questionnaire to assess and quantify the abdominal involvement in patients with the inherited life shortening multi-organ disease Cystic fibrosis.

In the stepwhise development of the patient reported outcome measures (PROM) repeadedly, CF-patients, their families as well as professionals working in different fields of CF-care will be included.


Options:
A: Development and evaluation of the CFAbd-Score (initially named JenAbdomen CF-Score), a CF-specific PROM following FDA recommendations (7 years); Development and evaluation of a diary for assessment and quantification of abdominal symptoms, a CF-specific PROM following FDA recommendations (7)
B: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
C: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation and Validation of a New Questionnaire to Identify and Quantify Abdominal Symptoms in Patients With Cystic Fibrosis Following FDA Guidelines: the CF Abd-Score (Primarily Named JenAbdomen-CF Score)
Brief Summary: Development, validation and evaluation of a new multimodal questionnaire to assess and quantify the abdominal involvement in patients with the inherited life shortening multi-organ disease Cystic fibrosis.

In the stepwhise development of the patient reported outcome measures (PROM) repeadedly, CF-patients, their families as well as professionals working in different fields of CF-care will be included.


Options:
A: Development and evaluation of the CFAbd-Score (initially named JenAbdomen CF-Score), a CF-specific PROM following FDA recommendations (7 years); Development and evaluation of a diary for assessment and quantification of abdominal symptoms, a CF-specific PROM following FDA recommendations (7)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Percent Coefficient of Fat Absorption (CFA%) (Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods)
D: Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA) (Open label baseline, end of 6 day double blind treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Quality of Life in Hematologic Cancer Survivors by Closing the Exercise Intention-Behavior Gap: a Phase II Randomized Controlled Trial of a Theory-based, Telephone-delivered Exercise Counselling Intervention
Brief Summary: This study evaluates the impact of a 12-week theory-based exercise telephone counselling program (versus a self-directed exercise group) on closing the exercise intention-behavior gap in a sample of hematologic cancer survivors.


Options:
A: Change in QoL between baseline and postintervention. (12 weeks)
B: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
C: Primary study outcome measures at the participant level will be minutes of moderate-intensity physical activity per week and exercise in MET-hrs/week. (Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.)
D: Change from baseline in Exercise Levels (Baseline and within 7 days of completing the 12-week intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Public Health: Durham
Brief Summary: The BETTER intervention consists of supportive meetings between a specially trained prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic disease prevention and screening activities (CDPS). The prevention practitioner nurse will assist participants to identify goals for accomplishing CDPS activities in the next 6 months. Promotion, recruitment of participants and delivery of the BETTER intervention will be adapted to meet the needs of the residents through the use of participatory research methods and community engagement strategies. The study population consists of individuals aged 40-64 years living in 10 designated areas or "clusters" within Durham Region in Oshawa and Whitby.

Objectives:

1. Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.
2. Evaluate whether the prevention practitioner was effective in helping people achieve their goals and explore whether this type of intervention could work in other settings.
3. Share what the investigators learn with government and other public health units in Ontario and across Canada.

Some clusters will receive the BETTER intervention right away and other clusters will be in a wait-list control group to receive the intervention 6 months later. Our main outcome is the change in a score that considers the number of preventive health items a person has achieved during the 6 months. The investigators will also be doing in-depth interviews and focus groups with health care providers, community organizations and people who live in the designated areas to understand whether the primary practitioner was effective.


Options:
A: Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up (Six months)
B: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
C: The percentage of participants attending the health check compared between the groups (one-year recruitment)
D: Composite outcome of multiple cardiovascular risk factors (2 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Two-arm, Interventional, Prospective, Open-label, Multi-center Trial to Evaluate the Safety & Effectiveness of FMT for Treatment of Adult Patients With Primary or Recurrent CDI, Using a Novel, Standardized Microbiota Transplantation System
Brief Summary: This study is a two-arm, interventional, prospective, open-label, multi-center clinical trial with randomized and non-randomized study groups to evaluate the safety and effectiveness of faecal microbiota transplantation (FMT) for the treatment of adult patients suffering from primary or recurrent Clostridium difficile infection (CDI), using a novel, standardized microbiota transplantation system.


Options:
A: A Randomized Controlled Trial of Oral Vancomycin Followed by Fecal Transplantation versus Tapering Oral Vancomycin Treatment for Recurrent Clostridium difficile Infection. (3 years)
B: Change in subjective symptom score (at 0 and 3 months)
C: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
D: Global cure rate at 10 weeks (10 weeks after enrolment); Time to clinical cure (Through study completion, an average of 18 months); Time to global cure (Through study completion, an average of 18 months); Cure rate at 2 weeks (2 weeks after enrolment); Cure rate at 4 weeks (4 weeks after enrolment); Treatment failure rate (Through study completion, an average of 18 months); Recurrence rate 8 weeks after clinical cure (8 weeks after clinical cure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)
Brief Summary: This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).


Options:
A: Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period (Pre-treatment; Week 6)
B: Mean Hb Level of Week 20 and Week 24 (Up to Week 24)
C: Number of participants with adverse events (Approximately 9 weeks); Blood pressure (Approximately 9 weeks); Heart rate (Approximately 9 weeks); Cmax (Pre-dose and up to 48 h post-dose); Cmax/D (Pre-dose and up to 48 h post-dose); AUC (Pre-dose and up to 48 h post-dose); AUC/D (Pre-dose and up to 48 h post-dose); Heart rate over 1 min (Pre-dose and up to 24 h post-dose); Standing blood pressure procedure (Starting from 2 h post-dose and up to 4 h post-dose); Impedance cardiography (Pre-dose and up tp 8 h post-dose)
D: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to 176 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Brief Summary: This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent Chronic Kidney Disease (DD-CKD).


Options:
A: Modeled Hgb Change From Baseline Over 4 Weeks of Treatment (Baseline (average of Week -2, -1 and Day 1) and Week 4)
B: US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Weeks 28 to 52), Regardless of Rescue Therapy (Baseline (Day 1, Week 0), Weeks 28 to 52); Ex-U.S. Submission: Mean Hb Change From Baseline to the Average Weeks 28 to 36, Without Having Received Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period for Participants Enrolled Under the Original Protocol (Baseline (Day 1, Week 0), Weeks 28 to 36)
C: Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period (Pre-treatment; Week 6)
D: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period (Baseline and week 12 to 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Study of Long-term Hemodialysis Catheter Removal, Versus Guidewire Exchange to Treat Catheter Related Blood Stream Infection
Brief Summary: Prospective, randomized Study of tunneled cuffed hemodialysis catheter removal and delayed replacement, versus exchange over a guidewire to treat catheter related blood stream infection


Options:
A: infection free survival (45 days)
B: Treatment Success (28 days)
C: The number of major catheter-related infections (CRI) defined as either catheter-related clinical sepsis without bloodstream infection or catheter-related bloodstream infection (CRBSI), during the ICU stay (after renal replacement therapy session)
D: Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days (Up to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.
Brief Summary: This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.


Options:
A: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)
B: Progression Free Survival (2 years)
C: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator (Up to ~38 months)
D: Maximum measured plasma concentration (336 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
Brief Summary: The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who were clinically stable after having been treated with eculizumab for at least 6 months.


Options:
A: Percent Change In Lactate Dehydrogenase Levels From Baseline To Day 183 (Baseline, Day 183)
B: The effect of OMS721 as measured by platelet count change from baseline (26 weeks)
C: Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA (Day 1 to 37 days after end of treatment, approximately up to 31 weeks.); Number of Participants With HSCT-TMA Who Respond to OMS721 (Day 1 to up to 2 years following the first dose of OMS721)
D: Proportion Of Participants With Normalization Of Lactate Dehydrogenase (LDH) Levels (Day 29 through Day 183); Percentage Of Participants Who Achieved Transfusion Avoidance (TA) (Baseline through Day 183)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
Brief Summary: This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction.

Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine.

Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.


Options:
A: Death (4 months); Death (8 months); Death (12 months); Death (16 months); Death (20 months); Death (24 months); Death (3 years); Death (4 years); Stroke/Systemic embolism (SE) (4 months); Stroke/Systemic embolism (SE) (8 months); Stroke/Systemic embolism (SE) (12 months); Stroke/Systemic embolism (SE) (16 months); Stroke/Systemic embolism (SE) (20 months); Stroke/Systemic embolism (SE) (24 months); Stroke/Systemic embolism (SE) (3 years); Stroke/Systemic embolism (SE) (4 years); Major bleeding (4 months); Major bleeding (8 months); Major bleeding (12 months); Major bleeding (16 months); Major bleeding (20 months); Major bleeding (24 months); Major bleeding (3 years); Major bleeding (4 years)
B: Atrial tachyarrhythmia (ATA) burden before and after 'CLOSE'-guided based PVI (Continuous monitoring (24 hours loop recording)); Long-term evaluation of ATA burden after a single 'CLOSE' guided PVI procedure (Continuous monitoring (24 hours loop recording))
C: Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. (From date of enrollment until time-to-first event over a median follow-up of 48.5 months.)
D: Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (From randomization until completion of the planned treatment phase, up to 1403 days.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Brief Summary: The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.


Options:
A: Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) (From randomisation until completion of the planned treatment period, up to 1040 days.)
B: Change of global myocardial function from baseline to 6 months of follow-up. (Recruitment period: 4,5 years. Follow-up assessment: 1 year. Analyses and reporting: 6 months. Overall duration: 6 years.)
C: Time to the First Occurrence of Any of the Following Adjudication-confirmed Components of the Primary Composite Endpoint 3-point Major Adverse Cardiovascular (CV) Events (3-point MACE): CV Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke. (From randomization to individual end of observation; up to 4.3 years)
D: Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke (up to 5.2 years); Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. (up to 5.2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Cohort Study With 52 Weeks Follow-up Investigating the Influence of Disease Perception on Functional Outcome Among Patients Referred From General Practice to Secondary Care for Treatment of Low Back Pain.
Brief Summary: The main purpose of the study is to investigate the importance of patients' beliefs regarding staying active despite low back pain, among patients referred from general practice to secondary care treatment in Denmark. It is hypothesised that patients believing that staying active will help them recover will have higher odds of a 30%-improvement in The Roland Morris Disability score after 52 weeks compared to patients disagreeing that staying active will lead to better recovery.


Options:
A: Antihypertensive medication adherence (8 weeks during the study)
B: The proportion of clinics that have satisfied each of the structure criteria. (Five years); The proportion of patients who have complied with the criterion process of care. (Five years); The proportion of patients who have achieved the target of outcomes of care (Five years)
C: Change in Rolland Morris Disability Questionnaire (Change from baseline to 52 weeks)
D: Adherence Rates to various methods of daily survey administration (35 days)

Answer: C