TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Blood Conservation in Cardiac Surgery Using a Novel Transfusion Algorithm Based on Point-of-care Testing-A Stepped-wedge Cluster Randomized Controlled Trial
Brief Summary: This multi-centre study will provide sound, generalizable data on the effectiveness of a POC-based algorithm to determine to what extent this guideline can reduce blood product transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at 10 participating hospitals. The proposed trial addresses several important research and clinical issues and has the potential to markedly improve the transfusion management and surgical care in general of cardiac surgery patients.

The intervention will be a novel POC-based algorithm that has been shown in a pilot study by us to be associated with a substantial reduction in blood product transfusions. The algorithm will employ viscoelastic and aggregometric POC-tests and an objective measure of blood loss. The primary outcome will be avoidance of red blood cell transfusion during hospitalization. The study has a 90% power to detect a 12% increase in avoidance rate. Secondary outcomes will include avoidance of red blood cell use and other blood products (plasma, platelets, and cryoprecipitate), units of blood products transfused, and adverse clinical outcomes related to transfusion (acute kidney injury, infections, and death). Data will also be collected for future health-economics analyses.

Largely due to the limitations of existing evidence, however, such algorithms are rarely used in clinical practice. The proposed trial will provide sound, generalizable data on the effectiveness of a POC-based algorithm to guide their future use. An integrated blood management algorithm that employs POC coagulation tests will reduce blood product transfusions in cardiac surgery, thereby improving clinical outcomes.

Does an integrated blood transfusion algorithm that employs POC coagulation tests applied across a network of hospitals reduce blood transfusions and associated adverse outcomes in cardiac surgery?


Options:
A: Bleeding Scores (intra-operatively and up to 24 hours postoperatively)
B: Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures (Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26)
C: Point Of Care (POC) Transfusion Algorithm Cardiac Study (2.5 years)
D: 24-hour Mortality (First 24 hours after ED admission); 30-day Mortality (First 30 days after ED admission); Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE) (From time of ED admission, for up to 72 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Perineal Massage in Childbirth: the Rate of Episiotomy Procedures, Perineal Tears and the Length of the Second Stage of Labour
Brief Summary: Objective To examine the effects of perineal massage applied during the action of birth on the frequency of episiotomy procedures, perineal tearing and the duration of the second stage of birth.

Methods The present study was a randomized controlled experimental. Women (284 women) were informed on the study and provided their written consent. 10-minute perineal massage with glycerine was applied to the women in the test group for 4 times during the first stage and 1 time in the second stage of birth. The women in the control group received the routine care procedure at the clinic.

Results According to the study findings, 31% of the women in the test group and 69.7% of the women in the control group were made subject to episiotomy (p\<0.05). In the test and control group 9.2%, 2.4% of the women developed spontaneous perineal laceration (p\>0.05). The average duration of the action of birth was 25.33 minutes in the test group and 28.18 minutes in the control group (p\<0.05).

Conclusion The study results indicate that perineal massage applied during the action of birth decreased the rate of episiotomy procedure and shortened the duration of the second stage of birth.


Options:
A: Perineal rupture grade III-IV (anal sphincter tears) (At delivery - within minutes - hours of randomization)
B: Episiotomy procedures (until completed the second stage of labour, about from 30 min to 24 h)
C: Number of patients with perineal tears (perineal tears are evaluated within 1 hour of delivery)
D: Grade I and II rupture during delivery (time at the delivery department (up to 12 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions
Brief Summary: The purpose of this study of is to compare subsequent fertility rates between hysteroscopy and aspirative curettage in the surgical treatment of incomplete spontaneous abortion


Options:
A: doxycycline side effects (24 hours)
B: Progressive intrauterine pregnancy > 22 WA (Until 2 years post surgery)
C: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)
D: Success rate of abortion (24 hours); Interval to abortion (24 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
Brief Summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
B: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)
C: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
D: Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a (Up to 5 days); Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5 (Up to 5 days); Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event (Up to 5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
Brief Summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.


Options:
A: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
B: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)
C: Percentage of Participants With Sustained Viral Response (SVR) at Week 72 (Week 72)
D: Safety Outcome Measures (Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection
Brief Summary: The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.


Options:
A: Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (At Follow-up Week 24)
B: Number of Participants With Sustained Virologic Response (SVR) (From follow-up week (FW) 24 up to end of follow-up (EOF))
C: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 24 weeks)
D: Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. (Baseline and 4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection
Brief Summary: The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.


Options:
A: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 24 weeks)
B: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
C: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)
D: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) (Weeks 4 and 12); Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24) (Follow-up Week 24); Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died (From start of study treatment (day 1) up to follow-up Week 48)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Cervical Cancer Disparity in South Florida: CBPR in Action
Brief Summary: The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.


Options:
A: Completing at least one recommended cancer screenings (colorectal, breast, cervical) (At six months and one year)
B: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
C: Number of Participants Completing a Self-sampling Test (2 to 6 months)
D: Proportion of participants self-reporting receipt of Pap test (One month post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Translating Knowledge for Action Against Stroke - Using 5 Minute Videos for Numeracy and Literacy Challenged Stroke Survivors and Caregivers to Improve Outcomes
Brief Summary: Two thirds of all strokes happen in developing countries like Pakistan. There is a serious lack of health literacy regarding survival after stroke. We hypothesize that our set of 5 minute videos that teach important skills to stroke survivors and their caregivers , that can be replayed in cell phones for extended learning, will increase their adherence to Medications after stroke and improve the control of blood pressure, elevated cholesterol and glucose in the participants getting cell phone based educational videos.


Options:
A: Low Density Lipoprotein Value (1 year); Systolic Blood Pressure Value (1 year); Hemoglobin A1C Value (1 year); Pill count of antiplatelet therapy medications (1 year)
B: Stroke Specific Health Related Quality of Life (6 months for (SSQoL) and 3 months for Perceived Energy Subdomain); Self-Efficacy to Manage Stroke Symptoms (6 months)
C: Increase in Adherence and Control of Stroke Risk Factors (1, 3, 6, 9 and 12 months)
D: Barthel Index (Change from Baseline to 2, 4, 12 and 22 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical Site Antisepsis Prior to Cesarean Delivery
Brief Summary: Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean related surgical site infection.


Options:
A: Number of Patients With Surgical Site Infection (4 weeks after cesarean delivery)
B: rate of postpartum endometritis (6 weeks)
C: rates of endometritis (2.5 years)
D: Postoperative wound infection (0-14 days postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Rehabilitation Strategies in Patients With Hemiparesis One Year or More After Stroke. Efficacy and Cost After One Year Treatment. A Randomized, Controlled, Multicenter, Single Blind Study
Brief Summary: In the situation of motor limitations that people often experience after stroke, current health systems cannot provide for the daily amount and duration of high intensity muscle stretch and motor training that would be required over protracted periods to involve muscle and brain plasticity. For patients with sufficient cognitive abilities, Guided Self-rehabilitation Contracts allow implementing stretch and training at high intensity and may result in meaningful functional improvement in chronic stages, as long as discipline persists over at least a year span.

This single blind control protocol will evaluate Guided Self-rehabilitation Contracts as against conventional therapy in the community, for a one year duration in persons with chronic hemiparesis after stroke.


Options:
A: Dynamic sitting balance and trunk control (Change from Baseline at week 5); Stepping (Change from Baseline at week 5)
B: Change in Fugl-Meyer assessment of paretic upper limb motor function (baseline, after sessions, 30 and 90 days)
C: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)
D: Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs) (After one year of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Parallel-group, Multi-centre Trial Using a Novel INCA Tracker Device to Measure and Monitor Compliance and Technique of Seretide Diskus Inhaler in a Community Pharmacy Setting
Brief Summary: The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to:

* Improved compliance with prescribed inhaler use
* Improved technique of inhaler use
* A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage.
* An improvement in patient quality of life scores


Options:
A: Rate of adherence (2 months and 6 months)
B: difference in change in systolic BP between the intervention and usual care groups (6 months)
C: Knowledge of Asthma (6 months after the first evaluation)
D: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Parallel-group, Multi-centre Trial Using a Novel INCA Tracker Device to Measure and Monitor Compliance and Technique of Seretide Diskus Inhaler in a Community Pharmacy Setting
Brief Summary: The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to:

* Improved compliance with prescribed inhaler use
* Improved technique of inhaler use
* A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage.
* An improvement in patient quality of life scores


Options:
A: 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)
B: Rate of adherence (2 months and 6 months)
C: Change in HADS-A score from baseline to three months follow-up (Three months)
D: Hospitalization-free Survival - Time to Event (From randomization until date of first hospitalization for COPD, assessed up to 26 months); Hazard Ratio for First COPD Hospitalization (26 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Requirements After Head Trauma
Brief Summary: TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients


Options:
A: FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status (Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion)
B: Hemoglobin difference (14 days)
C: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
D: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Requirements After Head Trauma
Brief Summary: TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients


Options:
A: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
B: Hemoglobin difference (14 days)
C: Mortality (90 day)
D: Mortality at the 45th day (45 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Requirements After Head Trauma
Brief Summary: TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients


Options:
A: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
B: Functional ability (Measured 10 days after surgery + repeated measurement during 90 days after surgery)
C: Mortality at the 45th day (45 days)
D: Hemoglobin difference (14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfusion Requirements After Head Trauma
Brief Summary: TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients


Options:
A: Functional ability (Measured 10 days after surgery + repeated measurement during 90 days after surgery)
B: Hemoglobin difference (14 days)
C: Postoperative Functional mobility; Restricting factors for functional mobility
D: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mentorship to Promote Cardiac Rehabilitation Enrollment: A Randomized Controlled Trial
Brief Summary: The current study is a randomized controlled trial, being conducted at two hospitals in Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an intervention group, in which they will receive mentorship from a volunteer cardiac rehabilitation peer mentor, and a control group, in which they will receive usual care. Patients in both groups will be tracked to determine if they are referred to cardiac rehabilitation and if they enroll in cardiac rehabilitation. We hypothesize that compared to cardiac inpatients who receive usual care, those cardiac inpatients who receive cardiac rehabilitation peer mentorship will be more likely to be referred to and enroll in cardiac rehabilitation.


Options:
A: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)
B: Recruitment (Baseline); Dropout (24 weeks); Satisfaction with intervention (12 weeks); Number of contacts (24 weeks); Content of contacts (24 weeks); CR attendance (12 weeks); CR attendance (24 weeks); Change in Health-related Quality of Life (Baseline to 24 weeks); Change in Self-efficacy (Baseline to 24 weeks); Change in symptoms of anxiety and depression (Baseline to 24 weeks); Change in dietary quality (Baseline to 24 weeks); Change in physical activity (Baseline to 24 weeks)
C: Total steps (last 30 days of intervention)
D: Health-related Quality of Life (SF-36v2-acute Form) (9 weeks)

Answer: A