TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial
Brief Summary: * Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients
* Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma
* Hypo/dysfibrinogenaemia plays an important role in TIC
* Early replacement of fibrinogen may improve outcomes
* Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
* The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP
* Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP
* It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies
* Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence
* Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay
* No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients
* Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm
* It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation)
* Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate
* It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible


Options:
A: Multiple Organ Failure (MOF) (Variable until 24h on ICU at the end of the IMP-administration)
B: Avoidance of allogeneic blood products transfusion (30 days)
C: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)
D: Time to administration of Fibrinogen Replacement from time of ROTEM analysis indicating fibrinogen supplementation is required First dose of Fibrinogen Concentrate or Cryoprecipitate required (3 Hours); Feasibility of administering FC within 30 mins of clinical scenario and ROTEM analysis suggesting Fibrinogen replacement is required (3 Hours); Effects on Fibrinogen levels during traumatic haemorrhage as measured by Clauss Fibrinogen (7 Days); Effects on Fibrinogen levels during traumatic haemorrhage as measured by FIBTEM (7 Days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Nurse Practitioner-Led Care on Health Related Quality Of Life in Adult Patients With Atrial Fibrillation - A Randomized Trial
Brief Summary: Atrial fibrillation (AF) is the most common heart rhythm disease characterized by an irregular heart rhythm of the top part (atria) of the heart. It may cause unpleasant symptoms as well as increases the person's risk of stroke and heart failure. With an ageing population, increasing rates of AF and limited access to specialists, new methods of care, like nurse practitioners (NP) need to be assessed to meet patient specific needs and provide sustainable care.

The objective of the project is to evaluate the effect of Nurse Practitioner-led care in people with AF on their quality of life.

The Canadian Healthcare system is overwhelmed, with increasing costs and wait times. Contributing to these issues, is AF is the most common arrhythmia accompanied with costly complications including stroke and heart failure. Currently family or emergency room physicians ask general cardiologists or specialized cardiologists, to provide care to patients with AF. Unfortunately, there is limited access to their services. NP's are nurses who have taken extra education at University to treat patients and prescribe medications. This research project involves an NP who has specialized training in AF patient management.

By utilizing an NP to provide care for patients with AF, the investigators hope to improve patient's quality of life and satisfaction with care. This may also reduce complications of AF.


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: Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups (At 6 months)
C: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire (Change from Baseline AFEQT at the 13th week (after the intervention) and 6 months (follow up))
D: The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death. (Follow up with minimum of 1 year and a maximum of 5 years and 10 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing Maternal, Newborn, and Child Health Platform in Bangladesh: A Cluster-randomized Operational Evaluation
Brief Summary: Inadequate maternal nutrition is likely to undermine the potential impact of infant and young child feeding (IYCF) improvements made in the Alive \& Thrive (A\&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do. In Phase 2, Alive \& Thrive decided to focus on integrating a package of maternal nutrition interventions in a large-scale maternal, newborn and child health program (MNCH). This proposed evaluation aims to assess the feasibility of integrating maternal nutrition interventions into an existing MNCH platform in Bangladesh, using a cluster-randomized evaluation design.


Options:
A: Use of iron-folic acid supplements (IFA tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016); Use of calcium supplements (Calcium tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016); Dietary diversity during pregnancy (Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016); Dietary micronutrient intakes (Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016); Coverage of maternal nutrition intervention (1 year)
B: 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)
C: Breastfeeding self-efficacy (Change from Baseline Breastfeeding self-efficacy at 6 months.)
D: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study.
Brief Summary: The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events.


Options:
A: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
B: Symptomatic DVT (3 months); Symptomatic PE (3 months); Unsuspected PE and DVT (3 months); Worsening of pulmonary vascular or venous obstruction (3 months)
C: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
D: Time to First Adjudicated ISTH MBE or CRNMBE (up to 30 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study.
Brief Summary: The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events.


Options:
A: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
B: Symptomatic DVT (3 months); Symptomatic PE (3 months); Unsuspected PE and DVT (3 months); Worsening of pulmonary vascular or venous obstruction (3 months)
C: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)
D: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre Randomized Controlled Trial of a "Freeze All and Transfer Later" Versus a Conventional "Fresh Embryo Transfer" Strategy for Assisted Reproductive Technology (ART) in Women With a Regular Menstrual Cycle
Brief Summary: The purpose of this study is to compare conventional fresh embryo transfer with a "freeze all and transfer later strategy" in assisted reproductive technology in terms of ongoing pregnancy rates, live birth rates as well as perinatal outcomes.


Options:
A: Live birth rates (≥ 35 weeks of gestation after the first single blastocyst embryo transfer according to fresh or deferred-frozen transfer.)
B: Ongoing pregnancy (12 weeks of gestation)
C: Ongoing pregnancy rates (Two years)
D: Clinical Pregnancy (7-8 weeks gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre Randomized Controlled Trial of a "Freeze All and Transfer Later" Versus a Conventional "Fresh Embryo Transfer" Strategy for Assisted Reproductive Technology (ART) in Women With a Regular Menstrual Cycle
Brief Summary: The purpose of this study is to compare conventional fresh embryo transfer with a "freeze all and transfer later strategy" in assisted reproductive technology in terms of ongoing pregnancy rates, live birth rates as well as perinatal outcomes.


Options:
A: live birth rate (10 months for group A, 12 months for group B)
B: Ongoing pregnancy rates (Two years)
C: Implantation rate (8 weeks after replacement)
D: Ongoing pregnancy (12 weeks of gestation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. A Randomized Phase 3 Study Comparing Rituximab With Dimethyl Fumarate in Early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.
Brief Summary: A randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.


Options:
A: Freedom of relapse (Within 2 years)
B: Annualized Relapse Rate (ARR) at 1 Year (1 Year)
C: Small effect of an intervention (immediate after completion of study); Moderate effect of an intervention (immediate after completion of study); Large effect of an intervention (immediate after completion of study)
D: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks (Week 96)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Magnetic Seizure Therapy for Schizophrenia
Brief Summary: This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety among schizophrenia patients. Half of the participants will be randomized to MST group, while the other half will be randomized to receive electroconvulsive therapy (ECT).


Options:
A: Hamilton Rating Scale for Depression, 24-Item (HRSD-24) (baseline (pre-treatment) and post-treatment)
B: Score on rating scale that corresponds to diagnosis: i) Hamilton Rating Scale for Depression, 24-item (HRSD-24); or ii) Yale-Brown Obsessive Compulsive Scale (Y-BOCS); or iii) Brief Psychiatric Rating Scale (BPRS) (Change from baseline in HRSD-24 / Y-BOCS / BPRS at date of symptom remission or date of the 24th treatment, whichever comes first, assessed up to 12 weeks); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 1 month after final treatment); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 2 months after final treatment); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 3 months after final treatment); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 6 months after final treatment)
C: Hamilton Rating Scale for Depression, 24-item (HRSD-24) (Change from baseline in HRSD-24 score at date of symptom remission or date of the 15th treatment, whichever comes first, assessed up to 6 months.)
D: changes of The Positive and Negative Syndrome Scale (PANSS) (At baseline, 4-week, 8-week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Veteran Engagement in Diabetes Prevention (CDA 13-267)
Brief Summary: This study will evaluate the effects of screening for type 2 diabetes mellitus (T2DM) and brief counseling about screening test results on weight and key health behaviors among Veterans with risk factors for T2DM. Study participants will be randomly assigned to one of two study groups: (1) Blood Test Group or (2) Brochure Group. Participants in the Blood Test Group will complete a blood test called hemoglobin A1c (HbA1c) which measures average blood sugar levels. Participants will receive brief counseling about the results from their primary care provider or someone authorized to speak on their behalf. Participants randomly selected for the Brochure Group will review a handout from the VA National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations. All participants will be asked to complete a survey prior to study group assignment, immediately after a Primary Care appointment, 3 months after enrollment, and 12 months after enrollment.


Options:
A: Change in ambulatory activity (walking) (12 months)
B: Weight Change From Baseline to 12 Months (12 months)
C: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
D: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: eRAPID Electronic Patient Self-Reporting of Adverse-events: Patient Information and aDvice: Feasibility Pilot Study in Radiotherapy
Brief Summary: The purpose of the Electronic Patient Self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) programme is to determine whether eRAPID (an online system for patients to self-report symptoms and side effects) can enhance patient care and improve the safe delivery of cancer treatments. The investigators hypothesise that patient symptoms will be detected earlier with more timely admissions and a reduction in overall hospital contacts. It is predicted that staff will save time recording symptoms and side effects and will be able to focus attention during clinical contacts on more severe side effects. eRAPID is a cost-effective approach to supporting patient self-management and reducing hospital/General Practitioner (GP)/community contacts.

The majority of the research will be run with systemic patients. This particular part of the research is a feasibility study in radiotherapy (RT) patients to test the platform in a different patient group.


Options:
A: 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)
B: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) (1 year after the date of primary surgery for colorectal cancer)
C: Number of participants with self-reported outcome data at each time-point (6 months); Proportion of missing data in patient outcome questionnaires (6 months); Appropriateness of patient outcome questionnaires by assessing ceiling and floor effects ( quality of life questionnaire) (6 months)
D: Rates of participant completion of >2 symptom reports (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of PTNS Versus Sham Efficacy in Treatment of Bladder Pain Syndrome
Brief Summary: This is a prospective, single center, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) through 12 weeks of therapy.


Options:
A: Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 (12 weeks)
B: Change From Baseline in Mean Average Daily Pain Score at Week 8 (Baseline, Week 8)
C: Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score (Baseline to 6 weeks and 6 to 12 weeks); Change in O'Leary-Sant Interstitial Cystitis Problem Index Score (Baseline to 6 weeks and 6 to 12 weeks)
D: The change in the average pain intensity score. (The change from baseline to the end of the double-blind phase in the mean average pain intensity score (12 weeks).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect and Safety of Combination Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
Brief Summary: A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules removal and complications improvement in long-term maintenance hemodialysis (MHD) patients.

There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.

Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.


Options:
A: Visual Analogue Scale (VAS) Score for Pruritus (VAS score at baseline and after 6 -week phototherapy)
B: Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period. (11 weeks)
C: Change From Baseline in Worst-itching 11-point Numerical Rating Scale (NRS) (2 weeks, 4 weeks and 8 week); Change From Baseline in Worst-itching Visual Analog Scale (VAS) (2 weeks, 4 weeks and 8 weeks); Change From Baseline in Itch Severity Score (2 weeks, 4 weeks and 8 weeks); Change From Baseline in Sleep Quality Assessment (2 weeks, 4 weeks and 8 weeks); Change From Baseline in QoL Assessment (Skindex-10) (2 weeks, 4 weeks and 8 weeks); The Mean Value in Treatment Satisfaction (Patient's Global Impression of Change ) (2 weeks, 4 weeks and 8 weeks); Change From Baseline in QoL Assessment (5-D-Itch Scale) (2 weeks, 4 weeks and 8 weeks); The Number of Patients in Excoriation (2 weeks, 4 weeks and 8 weeks)
D: the longitudinal changes of itching (every week, up to 12 weeks.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing an Enhanced Standardized Medication Therapy Management Approach Within a Primary Care Setting
Brief Summary: The purpose of this study is to identify challenges and successes associated with implementing an enhanced medication therapy management service in primary care practice.


Options:
A: Changes in decisional conflict (baseline and 3 month post intervention)
B: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
C: Change in Glycated hemoglobin (Measurements will be carried out before intervention and 6, 12 and 24 months after intervention)
D: Qualitative description of process-related challenges and successes as assessed by observation and survey (3 months)

Answer: D