TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Feeding America's Bravest: Mediterranean Diet-Based Interventions to Change Firefighters' Eating Habits and Improve Cardiovascular Risk Profiles
Brief Summary: The purpose of this study is to modify the food culture of the fire service by motivating firefighters and their families to incorporate Mediterranean diet principles at work and home through behavior change strategies that involve education, participation and incentives. The ultimate purpose is to lower firefighters' risks for CVD and cancer by successfully getting more firefighters and their families to adopt and incorporate the healthy eating principles behind the Mediterranean diet.


Options:
A: EQ-5D (Baseline, change in EQ-5D at 6 weeks)
B: Change in Body Weight (Change from baseline weight to weeks 6, 10, 16, 20, 24.)
C: Changes in Mediterranean diet scale (6, 12, and 24 months)
D: Weight loss (~1-2 years post baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preimplantation Genetic Screening in Patients With Male Factor Infertility
Brief Summary: This will be a prospective, randomized (1:1 ratio) clinical trial for patients with severe male-factor infertility with or without preimplantation genetic screening (PGS). Qualified 450 patients are randomized into either of two groups: group A will undergo intracytoplasmic sperm injection (ICSI) without PGS (225 cases), Group B will undergo ICSI with PGS (225 cases). The partners of all participants will receive the same protocol for ovarian stimulation and standardized luteal phase support.

The target population will be patients with severe male-factor infertility aged between 20 and 55 years, diagnosed by the ESHER Criteria (Non-obstructive oligospermia，asthenspermia). Women with other reasons of infertility (eg. advanced age, anovulation, endometriosis, and premature ovarian failure) are excluded.

The randomization will take place 3-6 days after the oocyte pick-up day by a computer randomization system. The pregnancy test results, pregnancy complications, congenital anomalies, neonatal complications will be followed up by checking medical records and telephone calls.


Options:
A: Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate (One year)
B: Clinical pregnancy (At 7 - 8 gestational weeks)
C: implantation rate (4 weeks)
D: live birth rate (42 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Motivational Interviewing to Support Oral AntiCoagulation Adherence in Patients With Non-valvular Atrial Fibrillation (MISOAC-AF): A Prospective Randomized Clinical Study
Brief Summary: The purpose of the study is to investigate the impact of motivational interviewing in the adherence of patients with AF to oral anticoagulation (OAC) regimens. Patients assigned to the intervention group will be interviewed and guided on the importance of adherence to OAC medication, and will be contacted at 1 week, 2 months, 6 months and 1 year after discharge for educational interactive sessions. Patients in the control group will receive usual treatment and will be contacted at 1 year after discharge.


Options:
A: 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)
B: Framingham Risk Score (15 months)
C: Adherence to OAC therapy (One year)
D: Composite endpoint death and cardiovascular events (1-year after randomization); Hospitalization (1-year after randomization); Composite endpoint death and broader cardiovascular events (1-year after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators study will recruit IgA nephropathy patients with proteinuria range from 0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were treated with Hydroxychloroquine 200-400mg/d according to eGFR. The proteinuria will recorded every two months and total four months. Then, the drug will be stopped for two months for observation of change of proteinuria.


Options:
A: Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 (Baseline (Day 1) and at Week 36)
B: Proteinuria （g/d） (every two months(total six months))
C: First occurrence of 40% decrease in eGFR from baseline (Baseline, until the first occurrence or 3 years); First occurrence of progression to continuous renal replacement (Until occurrence or 3 years); Death due to renal disease (Until occurrence or 3 years)
D: Patients reaching full clinical remission of their disease (at the end of the 3 year study period.); GFR loss of 15 ml/min or higher from baseline GFR (at the end of the 3 year study period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RENal Hemodialysis Patients ALlocated Apixaban Versus Warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial
Brief Summary: This is a prospective, randomized, open-label, blinded end-point evaluation trial. The patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and end-stage renal disease (ESRD) .


Options:
A: CRRT-filter life span in hours (during continuous renal replacement therapy up to 1 year); Overall survival in a 90day follow-up period (90 days)
B: absolute and relative change in coronary artery calcification score (18 months); absolute and relative change in thoracic aortic calcification score (18 months); absolute and relative change in pulse wave velocity (18 months)
C: Assess the safety of the factor Xa inhibitor apixaban versus a vitamin-K antagonist phenprocoumon in patients with NVAF and ESKD on hemodialysis. (1-60 months)
D: Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding (Randomization up to Month 15/Final Visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Team Approach to Polypharmacy Evaluation and Reduction Randomized Controlled Trial
Brief Summary: In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent medications can do more harm than good. Seniors take an average of 7 regular medications and studies link polypharmacy with adverse effects on morbidity, function and health service use. However, it is not clear to what extent these are reversible if medication burden is reduced.

This trial will test the effects on medication numbers and patient health outcomes of an intervention to polypharmacy. This study will test a program focused on medication reduction number and dose. Prioritizing medications according to the patient's preference as reducing the dose also reduces the risk of drug side effects.

Patients, aged 70 years of age or older and are taking ≥5 medications, will randomly receive the program immediately or at 6 months. The program involves information gathering from the patient, including systematically seeking patients priorities and preferences medication review with the pharmacist and then a consultation with the family doctor. The intervention is focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into an electronic clinical pathway incorporating monitoring and follow up systems.

This study will examine effects on patient and health relevant outcome measures as well as qualitative research exploring patients' and clinicians' experiences of reducing medication burden. The results will be used to determine whether this system can be implemented as part of routine preventative care in primary care for older adults.


Options:
A: Satisfaction With Social Participation (Baseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) months); Hearing-Specific Health-Related Quality of Life (Baseline, at 5, 10, 15, 20 and 25 months)
B: NPI-NH agitation/aggression (8 weeks and 12 weeks)
C: Successful discontinuation (mean difference in number of medications) (Baseline, 6 months)
D: Software/user problems (6 months); functionality problems (6 months); workload (6 months); medication chart review (6 months); practical problems (6 months); GPs that refuse (6 months); non-consenting eligible residents (n) (6 months); Non-consenting proxies for eligible residents (n) (6 months); Optimeds completion (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Impact of Telemedicine in Crohn's Disease and Ulcerative Colitis: Study Teccu
Brief Summary: Pragmatic clinical trial, randomized, controlled parallel, 3 group (group technology platform, call group and control group), developed in the monograph Reference Unit of Inflammatory Bowel Disease Valencia (single-center).


Options:
A: Improvement in Quality Indicators (adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations) (up to 2 years)
B: Clinical Remission (6 months); Clinical Remission (6 months)
C: Outpatient hospital visits (1 year); Satisfaction (1 year)
D: Adherence (beginning at baseline - week 20)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Regional Ventilation Pattern During High Flow Nasal Cannula Between Conventional Low Flow System Nasal Cannula in Patients With Mild to Moderate Hypoxia
Brief Summary: High-flow nasal cannula (HFNC) that uses heated and humidified oxygen was recently introduced for bedside care. It has been shown to be associated with reduced risks of tracheal intubation rates and mortality in adult hypoxic patients.

The mechanisms of the effects of HFNC are thought to be related to the favorable effects of the heated and humidified gas, the high-flow rate used to minimize the entrainment of room air, and an increase in the ventilation efficiency, including the elimination of nasopharyngeal dead space, positive end-expiratory pressure (PEEP) effects, and improvements in paradoxical abdominal movement. Regarding the effects on lung volume, global ventilation in the lungs increases during HFNC, which is thought to attribute to PEEP effects. However, how regional ventilation is affected during HFNC in comparison with conventional NC remains unknown.

Because PEEP in mechanically ventilated patients improves the regional homogeneity of ventilation, investigators postulated that HFNC via PEEP effects would result in more homogeneous regional distributions in the ventilation changes. Investigators therefore assessed global and regional ventilation in patients with hypoxia receiving care via HFNC using electric impedance tomography and compared these results with conventional nasal cannula.


Options:
A: Arterial partial pressure of carbon dioxide (PaCO2) (2 hours after randomization)
B: Reintubation at Day 7 (up to 7 days)
C: Tidal variation (Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy))
D: To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation (at day 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Regional Ventilation Pattern During High Flow Nasal Cannula Between Conventional Low Flow System Nasal Cannula in Patients With Mild to Moderate Hypoxia
Brief Summary: High-flow nasal cannula (HFNC) that uses heated and humidified oxygen was recently introduced for bedside care. It has been shown to be associated with reduced risks of tracheal intubation rates and mortality in adult hypoxic patients.

The mechanisms of the effects of HFNC are thought to be related to the favorable effects of the heated and humidified gas, the high-flow rate used to minimize the entrainment of room air, and an increase in the ventilation efficiency, including the elimination of nasopharyngeal dead space, positive end-expiratory pressure (PEEP) effects, and improvements in paradoxical abdominal movement. Regarding the effects on lung volume, global ventilation in the lungs increases during HFNC, which is thought to attribute to PEEP effects. However, how regional ventilation is affected during HFNC in comparison with conventional NC remains unknown.

Because PEEP in mechanically ventilated patients improves the regional homogeneity of ventilation, investigators postulated that HFNC via PEEP effects would result in more homogeneous regional distributions in the ventilation changes. Investigators therefore assessed global and regional ventilation in patients with hypoxia receiving care via HFNC using electric impedance tomography and compared these results with conventional nasal cannula.


Options:
A: Oxygenation (PaO2/FiO2 ratio) (Up to 48 hours after extubation)
B: Arterial partial pressure of carbon dioxide (PaCO2) (2 hours after randomization)
C: The decrease of diaphragmatic workload (thickening fraction of the diaphragm) (30 minutes)
D: Tidal variation (Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial
Brief Summary: This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.


Options:
A: Pain at Time of Uterine Evacuation (During the procedure on Study Day 1)
B: Visual Analog Pain Score for Mean Maximum Procedural Pain (Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure)
C: Pain Scores on the Visual Analog Scale (Three months)
D: pain reduction (nine months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: STAR-TREC: Can We Save the Rectum by Watchful Waiting or TransAnal Surgery Following (chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?
Brief Summary: Bowel cancer is the second most common tumour with 41 000 new cases diagnosed annually in the UK, 447 000 across Europe and 1.36 million worldwide; of which one third are located in the rectum. Standard primary radical Total Mesorectal Excision (TME) surgery is an oncologically effective treatment for early stage rectal cancer. However, resection of a low rectal tumour requires a permanent stoma in approximately 10% of cases while many more patients have a temporary stoma, some of which are not reversed. Radical surgery, which evolved to treat locally advanced, symptomatic tumours, may not be the optimal method of treatment for early screen-detected tumours and an organ preserving strategy may generate significantly less morbidity without substantially compromising oncological outcomes.

STAR-TREC is a rolling phase II/III study. Phase II aimed to assess the feasibility of a large, multi-centre randomised trial comparing radical surgery versus two contrasting organ saving treatments followed by selective transanal microsurgery. Phase III will evaluate two contrasting organ preservation strategies in terms of organ preservation rates, toxicity (clinician and patient-reported) and Health-Related Quality of Life (HRQoL).


Options:
A: Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after (24 months)
B: Local recurrence (2 years)
C: N/A
D: Phase II (Feasibility study) Primary Outcome: Recruitment Rate (24 Months); Phase III Primary Outcome: Organ Preservation (30 Months from start day of (chemo)radiotherapy treatment.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Dietary Sodium Reduction in Kidney Disease Patients With Albuminuria
Brief Summary: The proposed randomized controlled trial will test the effect of dietary sodium reduction on albuminuria in patients with proteinuric chronic kidney disease. Results from this study will clarify the role of dietary sodium reduction in management of patients with proteinuric chronic kidney disease and its potential to halt the progression of chronic kidney disease.


Options:
A: Primary Outcome: Change in volume status (intracellular, extracellular volume, and total body water) as measured by BIA using both whole body and segmental techniques (12 Weeks)
B: Net Change in Urinary Albumin-to-Creatinine Ratio (ACR) (Assessed twice at baseline, once at week 12, and twice at week 24)
C: 24-hour Urinary Sodium Excretion (1 month); 24-hour Urinary Salt Excretion (1 month)
D: Quality of life (12 months)

Answer: B
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 Complement Inhibitor-Naïve Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Brief Summary: The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).


Options:
A: Platelet Count Change From Baseline to 26 Weeks (From Baseline to 26 weeks); Percentage of Patients With Platelet Count Normalization (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks)
B: 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)
C: Adverse events and serious adverse events and their severity and relationship to the drug (12 weeks)
D: Percentage of Patients With Complete TMA Response (Through 26 weeks); Percentage of Patients With Modified Complete TMA Response (Through 26 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PREgnancy-associated Pelvic Floor Health Knowledge And REDuction of Symptoms: The PREPARED Trial
Brief Summary: The pelvic floor is composed of muscles and connective tissue which acts to provide support for pelvic organs, and weakness or injury to the pelvic floor can result in pelvic floor dysfunction. Respect for patient autonomy is a guiding principle in medicine and is of increasing importance for patients. The PREPARED Trial hopes to demonstrate whether a single workshop on pelvic floor health during pregnancy will lead to improved knowledge of pelvic floor symptoms postpartum, increase the practice of pelvic floor muscle exercises, increase satisfaction with their delivery experience, and change participants preferences and thoughts surrounding various modes of delivery.


Options:
A: Difference in scores on a pelvic floor knowledge questionnaire at 6 weeks postpartum between intervention and control groups (At 6 weeks post-partum)
B: Prematurity (Women will be interviewed at hospital soon after birth (up to 2 days after delivering))
C: Body mass index of the offsprings (0-24 postpartum months); Fetus body composition (0-24 postpartum months); Change from baseline in Maternal gestational weight gain (40-42 weeks of gestation); Changes in Baby motor development (0-24 postpartum months); Recovery time to pre-gestational weight (6-12 postpartum months); Glycemia level of the offsprings (0-24 postpartum months); Postpartum depression (0-12 postpartum months); Change from baseline in Body image satisfaction (up to 36 weeks); Changes from baseline in maternal quality of life (up to 36 weeks); Placenta measurements (At delivery)
D: pain (6 weeks); Disability (6 weeks); Pelvic Floor Muscle activity (6 weeks); Abdominal muscles(Transverse Abdominis,Internal Oblique,External Oblique) thickness (6 weeks); Multifidus muscle thickness and crass section area(S1 level) (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PREgnancy-associated Pelvic Floor Health Knowledge And REDuction of Symptoms: The PREPARED Trial
Brief Summary: The pelvic floor is composed of muscles and connective tissue which acts to provide support for pelvic organs, and weakness or injury to the pelvic floor can result in pelvic floor dysfunction. Respect for patient autonomy is a guiding principle in medicine and is of increasing importance for patients. The PREPARED Trial hopes to demonstrate whether a single workshop on pelvic floor health during pregnancy will lead to improved knowledge of pelvic floor symptoms postpartum, increase the practice of pelvic floor muscle exercises, increase satisfaction with their delivery experience, and change participants preferences and thoughts surrounding various modes of delivery.


Options:
A: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)
B: Urinary Incontinence (Prevalence) (6 months postpartum (end of intervention))
C: Difference in scores on a pelvic floor knowledge questionnaire at 6 weeks postpartum between intervention and control groups (At 6 weeks post-partum)
D: UI reduction (12 months)

Answer: C