TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Hospitalization at Home Pilot: The Acute Care Home Hospital Program for Adults
Brief Summary: The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.


Options:
A: Total cost of hospitalization, $ (Day of admission to day of discharge)
B: NIHSS Stroke Scale, relapse rate (360 days)
C: Mortality, dependence, psychoscial outcome; Mortality, dependence and psychosocial outcome (6 months endpoint)
D: Total direct cost of hospitalization, $ (From date of admission to date of discharge, an expected average of 4 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hospitalization at Home Pilot: The Acute Care Home Hospital Program for Adults
Brief Summary: The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.


Options:
A: The number of ED presentations (1 year after randomization.)
B: Number of hospitalizations (2011)
C: Total cost of hospitalization, $ (Day of admission to day of discharge)
D: Death (30 days, 3 months, 6 months); readmission (30 days, 3 months, 6 months); need for additional Prednisolone, additional antibiotics , NIV or life support machine (respirator) (30 days, 3 months, 6 months); Self-efficacy (3 days); Cognitive function (3 days and six weeks after discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Topical Tranexamic Acid and Floseal® on Blood Loss After Total Knee Arthroplasty in Patients With a Thromboembolic Risk
Brief Summary: Our purpose of this study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of this two topical hemostatic agents in primary TKA procedures in patients with a risk of thromboembolic events. We will also observe if there is increased risk of thromboembolism by use of topical hemostatic agents.


Options:
A: Total blood loss after operation (From the operation to the postoperative day 3 or 4); Decrease of hemoglobin level after operation (From the operation to the postoperative day 14)
B: Fall in post-operative hemoglobin level after total knee replacement (First 7 days after surgery)
C: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)
D: The volume of postoperative blood loss in the drain (48 hours after the operation); Changes from baseline hemoglobin concentrations (48 hours after the operation); unit of blood transfusion (48 hours after the operation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE - CORRECTION/CONVERSION)
Brief Summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).


Options:
A: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period (Baseline and weeks 14 to 17)
B: 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 Week 208)
C: 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)
D: Hemoglobin level (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Corneal Accelerated Crosslinking Versus Conventional Treatment for Infectious Keratitis
Brief Summary: The objective of this study is to evaluate the efficacy and safety of accelerated cross-linking (Avedro Inc., Waltham, USA) in the management of microbial keratitis as adjunctive therapy.


Options:
A: time of complete healing (days) (180 days)
B: Healing (Three months)
C: Microbiological Cure on Repeat Culture (4 to 24 hours after enrollment)
D: Maximum Keratometry (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Iball Mobile Health Technology in Pelvic Floor Muscle Training in the Postpartum Period: a Pilot Mixed Methods Study
Brief Summary: he postpartum period is vulnerable to dysfunction of the pelvic floor musculature, which is associated with incontinence, pain, reduced stability of the core and functional deficits. The Society of Obstetricians and Gynaecologists of Canada recommends instruction on the correct performance of pelvic floor muscle exercises, commonly known as Kegels, as standard care. However, only a small proportion of women seek medical care for incontinence in Canada. Recently, there has been an influx of mobile Health technology applications marketed for pelvic floor restoration and fitness that have not been studied. The existence of mHealth technologies may represent an innovative mode to support pelvic health, however systematic exploration to substantiate claims and proposed benefit is required. This pilot study aims to understand the utility of a new mobile health application, iball, as a rehabilitation tool to promote optimal pelvic floor function and to correct pregnancy related pelvic floor dysfunction. The iball is comprised of a device and a mobile app, and it has been brought to market in Europe as a consumer product. The study aims to assess the acceptability, feasibility, and effectiveness of the iball as a pelvic floor muscle training intervention, in comparison to standard care.


Options:
A: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)
B: Prematurity (Women will be interviewed at hospital soon after birth (up to 2 days after delivering))
C: Urinary Incontinence (Prevalence) (6 months postpartum (end of intervention))
D: Acceptability of the iball intervention (via qualitative data collection) (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Iball Mobile Health Technology in Pelvic Floor Muscle Training in the Postpartum Period: a Pilot Mixed Methods Study
Brief Summary: he postpartum period is vulnerable to dysfunction of the pelvic floor musculature, which is associated with incontinence, pain, reduced stability of the core and functional deficits. The Society of Obstetricians and Gynaecologists of Canada recommends instruction on the correct performance of pelvic floor muscle exercises, commonly known as Kegels, as standard care. However, only a small proportion of women seek medical care for incontinence in Canada. Recently, there has been an influx of mobile Health technology applications marketed for pelvic floor restoration and fitness that have not been studied. The existence of mHealth technologies may represent an innovative mode to support pelvic health, however systematic exploration to substantiate claims and proposed benefit is required. This pilot study aims to understand the utility of a new mobile health application, iball, as a rehabilitation tool to promote optimal pelvic floor function and to correct pregnancy related pelvic floor dysfunction. The iball is comprised of a device and a mobile app, and it has been brought to market in Europe as a consumer product. The study aims to assess the acceptability, feasibility, and effectiveness of the iball as a pelvic floor muscle training intervention, in comparison to standard care.


Options:
A: Acceptability of the iball intervention (via qualitative data collection) (16 weeks)
B: Placental weight (At delivery); Fetal birth weight (At delivery); Change from baseline in maternal gestational weight (38-42 weeks of gestation)
C: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)
D: Contraction strength (Change of contraction strength is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )); Contraction pressure (Change of contraction pressure is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety and Efficacy of an Edoxaban-based Compared to a Vitamin K Antagonist-based Antithrombotic Regimen in Subjects With Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) With Stent Placement.
Brief Summary: There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting. This study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a vitamin K antagonist (VKA)-based antithrombotic regimen in subjects with AF following PCI with stent placement. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.


Options:
A: Composite Safety Endpoint (one year); Primary Efficacy Endpoint (one year)
B: Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen (Day 1 to 12 months postdose)
C: The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria). (1 year)
D: The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period (Approximately 6 months); The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period (Approximately 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Phase II Study Of Nintedanib (BIBF1120) Compared To Chemotherapy in Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium
Brief Summary: The trial will recruit up to 120 patients; 90 with ovarian clear cell carcinoma and up to 30 with endometrial clear cell carcinoma. Patients will be randomised between chemotherapy and Nintedanib 200mg twice daily oral administration (PO) continuously. The primary diagnosis must be histologically confirmed and central pathological review of the presenting tumour or biopsy of relapsed disease must find at least 50% clear cell carcinoma with no serous differentiation


Options:
A: Progression Free Survival (PFS) (from date of randomisation to date of progression or death, which ever occurs earlier. Assessed up to 5 years 3 months)
B: Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (after 6 weeks (2 cycles))
C: investigator-determined progression-free survival (every 12 weeks until progression or up to 30 months (whichever occurs first))
D: Progression-free Survival(PFS) (up to 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Phase II Study Of Nintedanib (BIBF1120) Compared To Chemotherapy in Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium
Brief Summary: The trial will recruit up to 120 patients; 90 with ovarian clear cell carcinoma and up to 30 with endometrial clear cell carcinoma. Patients will be randomised between chemotherapy and Nintedanib 200mg twice daily oral administration (PO) continuously. The primary diagnosis must be histologically confirmed and central pathological review of the presenting tumour or biopsy of relapsed disease must find at least 50% clear cell carcinoma with no serous differentiation


Options:
A: Complete response rate (average 24 months)
B: Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b) (Cycle 1 (21-days)); Objective Response Rates (ORR) - Part 2 (Phase 2a) (12 months); Measure the Progression Free Survival (PFS)- Part 3 ( Phase 3) (12 Months)
C: Progression Free Survival (PFS) (from date of randomisation to date of progression or death, which ever occurs earlier. Assessed up to 5 years 3 months)
D: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: In dentistry, 3D printing technology is gaining interest. One of the potential application is to construct appliances on 3D reconstructed study models.

The purpose of this study is to compare vacuum formed thermoplastic orthodontic retainers (VFR) constructed on conventional orthodontic study models and reconstructed 3D study models by assessing the oral health-related quality of life (OHRQoL) instrument, Little's Irregularity Index (LII) and compliance.


Options:
A: Compliance of retainer wear (3 months)
B: Wear of removable retainer per day (hours) in the intervention and the control groups (3 months - 6 months - 12 months)
C: Stability (From debonding (T1), and after 6, 12, 24, 36 and 60 months in retention phase (T4, T5, T6, T7, and T8 respectively))
D: Oral Health-Related Quality Of Life (6 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response
Brief Summary: As the patents for brand-name immunosuppressive medications expire, there is increasing interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies showing bioequivalence, questions remain regarding the clinical impact of use of generic immunosuppression.

The most important immunosuppressive agent in the modern transplant era is arguably tacrolimus, a calcineurin-inhibitor with a narrow therapeutic index. This study seeks to answer the question regarding the clinical impact of generic tacrolimus use as measured primarily by acute rejection, loss of graft function, and patient death through a randomized trial of 2 phases: Brand tacrolimus only, and Generic A tacrolimus only. Given that kidney transplantations are the most commonly performed transplants with well-defined measures of rejection and graft failure, this organs will be studied in a six-center study designed to accrue the target number of transplant recipients within the one-year study period.

The study has now been branched off into 2 phases. Phase 1: consists of randomization of patients onto brand and generic tacrolimus. This was completed once 40 brand patients were enrolled. Phase 2: consists of patients being enrolled only on generic tacrolimus (standard of care from subject's insurance). This will be completed once there is a total of 160 generic participants. 200 participants total in the study.


Options:
A: Morisky Medical Adherence Assessment questionnaire (2 years)
B: Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period (12 months)
C: Time to First Occurrence of Acute Rejection, Failure, Death (1 year post-transplant)
D: Immunosuppression (Tacrolimus) Adherence (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Intervention for Improving Drug Prescription in Primary Care Patients With Multimorbidity and Polypharmacy: Study Protocol of a Cluster Randomized Clinical Trial (Multi-PAP Project)
Brief Summary: This study assesses the effectiveness of a complex intervention in young-old patients with multimorbidity and polypharmacy aimed at improving physician drug prescription in primary care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) months from baseline compared to usual care.


Options:
A: Medication Appropriateness Index (MAI) score (Change from baseline MAI score at 6 months)
B: Life quality evaluation of both groups (control and intervention) at 0, 7, 13, and 19 months from the beginning of the inclusion filled in by the patient or his/her main caregiver (husband or wife, a friend...) thanks to a closed envelope given by the GP (at 0, 7, 13 and 19 months from the beginning of the incusion)
C: Qualitative description of process-related challenges and successes as assessed by observation and survey (3 months)
D: Health literacy levels (Measured at Week 6 and Months 6, 12, 18, and 24); Blood pressure control (Measured at Week 6 and Months 6, 12, 18, and 24); Reduction in blood pressure (Measured at Month 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Intervention for Improving Drug Prescription in Primary Care Patients With Multimorbidity and Polypharmacy: Study Protocol of a Cluster Randomized Clinical Trial (Multi-PAP Project)
Brief Summary: This study assesses the effectiveness of a complex intervention in young-old patients with multimorbidity and polypharmacy aimed at improving physician drug prescription in primary care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) months from baseline compared to usual care.


Options:
A: Medication Appropriateness Index (MAI) score (Change from baseline MAI score at 6 months)
B: Successful medication discontinuation (4 months)
C: Effects on hospital visits (1 year)
D: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Intervention for Improving Drug Prescription in Primary Care Patients With Multimorbidity and Polypharmacy: Study Protocol of a Cluster Randomized Clinical Trial (Multi-PAP Project)
Brief Summary: This study assesses the effectiveness of a complex intervention in young-old patients with multimorbidity and polypharmacy aimed at improving physician drug prescription in primary care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) months from baseline compared to usual care.


Options:
A: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 18 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 18 months)
B: Medication Appropriateness Index (MAI)-Score (6 months from baseline)
C: Medication Appropriateness Index (MAI) score (Change from baseline MAI score at 6 months)
D: Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers) (Interview performed 30-35 days post-discharge.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist Oral Anticoagulants (NOAC) With Tranexamic Acid
Brief Summary: Novel, non-vitamin K antagonist oral anticoagulants (NOAC) target selected players in the coagulation cascade as the direct thrombin inhibitor dabigatran and the factor Xa-inhibitors apixaban and rivaroxaban. Intracerebral hemorrhage (ICH) is the most feared complication of NOAC treatment (NOAC-ICH).

Outcome of NOAC-ICH can be devastating and is a major cause of death and disability. There is no proven treatment for NOAC-ICH. Hematoma expansion (HE) is associated with unfavorable outcome. Tranexamic acid (TA) is an anti-fibrinolytic drug that is used in a number of bleeding conditions other than ICH.


Options:
A: ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume. (24+/-3 hours)
B: INR ≤ 1.2 within 3 hours after start of drug infusion (3 hours)
C: Number of Study Subjects With Life-threatening Thromboembolic Complications (through day 4 after completion of study drug administration); Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours. (From baseline to 24 hours); The Sensitivity of the Spot Sign for Predicting Hematoma Growth (Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.); The Specificity of the Spot Sign for Predicting Hematoma Growth (Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.)
D: Hematoma expansion (up to 27 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-acting Naltrexone for Pre-release Prisoners: A Randomized Trial of Mobile Treatment
Brief Summary: This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence.


Options:
A: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month (6 months)
B: Opioid positive drug tests (4 and 12 months post-baseline)
C: Post-Release Opioid Relapse (Four weeks post-release)
D: treatment adherence (six months); Any illicit opioid used (1,2,3,4,5,6,7 and 12-months following release from prison); re-arrest (12-months following release from prison); re-incarceration (12-months following release from prison); criminal activity (1,2,3,4,5,6,7 and 12-months following release from prison); Injection drug use and HIV sexual risk factors (6 and 12-months following release from prison)

Answer: D