TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Investigators Reduce Urinary Catheter Use and Lower Urinary Tract Infection Among Women Undergoing Benign Gynecologic Surgery?
Brief Summary: This is a randomized comparative trial investigating two different catheter management strategies among post-gynecologic surgery patients. Women undergoing any benign gynecologic surgery wherein they are anticipated to stay at least overnight and in whom no prolapse or urinary tract surgery was concurrently performed, will be randomly assigned to either conventional urinary catheter care removal on post-operative day 1 or same day surgery urinary catheter removal. Patient satisfaction and lower urinary tract symptoms including urine culture and antibiotic use will be tracked across both cohorts over the 2 weeks following the index surgery.


Options:
A: Foley Duration (Between 4 hours after surgery completion to 24 hours after surgery completion)
B: Post-operative urinary retention requiring re-catheterisation (14 days following urethral catheter removal)
C: Need for insertion of catheter after Foley removed. (participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
D: Hospital stay (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3 Multicenter, Dose-response Study to Assess Efficacy and Safety of ZS (Sodium Zirconium Cyclosilicate), in Japanese Patients With Hyperkalemia
Brief Summary: To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese patients with hyperkalemia (serum potassium \[S-K\] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).


Options:
A: Percentage of Responders (Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.)
B: Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). (22 Days; Maintenance Phase Days 8 - 29, inclusive.)
C: Change in Serum Potassium From Part A Baseline to Part A Week 4 (Part A Baseline to Part A Week 4); Change in Serum Potassium From Part B Baseline (Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L)
D: Exponential Rate of Change in Serum Potassium (S-K) Values During the Initial 48 Hours of Study Drug Treatment (From 0 to 48 hours.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Mobile Phone-based Telemonitoring Application for Self-management and Clinical Decision Support for Patients With Complex Chronic Conditions
Brief Summary: Remote patient monitoring is a potential component for the management of chronic conditions that may provide reliable and real-time physiological measurements for clinical decision support, alerting, and patient self-management. The purpose of this study is to evaluate an UHN-built remote monitoring system for patients with complex chronic conditions called Medly.


Options:
A: Total direct cost of hospitalization, $ (From date of admission to date of discharge, an expected average of 4 days)
B: Insomnia (Up to 18 weeks)
C: Plasma concentration levels over time of biomarkers of oxidative stress, apoptosis, inflammation and platelet aggregation (Within 8hours from baseline)
D: Quality of Life as Measured by SF-36 (Baseline, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Expanding Access to Home-Based Palliative Care Through Primary Care Medical Groups
Brief Summary: This study will test the effectiveness of integrating an evidence-based model of home-based palliative (HBPC) within primary care clinics on patient and caregiver outcomes. The investigators will conduct a randomized controlled trial, randomizing 1,155 seriously ill patients (and approximately 884 family caregivers) who receive primary care from 30-40 regional accountable care organizations (ACOs) in California to one of two study groups: HBPC or enhanced usual care (EUC). Follow-up data will be collected via telephone surveys with patients at 1- and 2-months and with caregivers at 1- and 2-months, and, as appropriate, following the death of the patient.


Options:
A: Healthcare utilization (up to 12 months)
B: Change in Score on the Edmonton Symptom Assessment for patients (At baseline and 1- and 2- months following baseline); Change in Score on Hospital Anxiety and Depression Scale (HADS) for patients (At baseline and 1- and 2- months following baseline)
C: changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks (baseline and after 4, 16 and 24 weeks)
D: Place of care and death (Up to 4.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Hydroxyurea Therapy in Children With Sickle Cell Anemia In Malaria Endemic Areas: The NOHARM Maximum Tolerated Dose (MTD) Study
Brief Summary: The Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM) study is the first placebo-controlled randomized clinical trial of hydroxyurea treatment in a malaria endemic region. NOHARM has now achieved full enrollment; all children have completed the blinded portion of the protocol and are in the open-label study treatment portion.

This extension study of maximum tolerated dose (MTD), addresses the next critical set of questions about the optimal dosing and monitoring of hydroxyurea treatment for children with SCA in low-resource settings. By providing guidance about optimal hydroxyurea treatment, the NOHARM MTD Study will directly inform policies that can transform the health of African children living with SCA.


Options:
A: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
B: Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs (Baseline up to 30 days post last dose on Day 29); Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Neurologic Function (Baseline up to Day 29); Number of Participants With Potentially Clinically Important (PCI) Change in Physical Examination Findings (Baseline up to 30 days post last dose on Day 29); Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings (Baseline up to 30 days post last dose on Day 29); Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Symptoms of Sickle Cell Disease (Baseline up to 30 days post last dose on Day 29); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 to 30 days post last dose on Day 29); Number of Participants With Laboratory Test Abnormalities (Baseline up to 30 days post last dose on Day 29)
C: Proportion of children with average hemoglobin ≥9.0 g/dL or average HbF ≥20% (Over 24 month period on study drug)
D: Number of Malaria Episodes (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Study on Integrating Home-based Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway (PATHWAY STUDY WS3)
Brief Summary: Depression and anxiety are highly prevalent in people with heart disease, causing immense human and economic burden. Available pharmacological and psychological interventions have limited efficacy and the needs of these patients are not being met in cardiac rehabilitation services despite emphasis in key NHS policy.

Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention called metacognitive therapy (MCT) that reduces this style of thinking alleviates depression and anxiety in mental health settings.

This is a single-blind feasibility randomised controlled trial of metacognitive therapy delivered in a home-based format (Home-MCT). The aim of the study is to evaluate the acceptability and feasibility of integrating Home-MCT into cardiac rehabilitation services and to provide provisional evidence of effectiveness and cost-effectiveness on Home-MCT.


Options:
A: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. (6 months)
B: 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)
C: Quality of Life, Heart Failure Disease Biomarkers and Clinical Outcomes (yearly)
D: Acceptability (From the completion of the manual till 4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Feasibility Study on Integrating Home-based Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway (PATHWAY STUDY WS3)
Brief Summary: Depression and anxiety are highly prevalent in people with heart disease, causing immense human and economic burden. Available pharmacological and psychological interventions have limited efficacy and the needs of these patients are not being met in cardiac rehabilitation services despite emphasis in key NHS policy.

Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention called metacognitive therapy (MCT) that reduces this style of thinking alleviates depression and anxiety in mental health settings.

This is a single-blind feasibility randomised controlled trial of metacognitive therapy delivered in a home-based format (Home-MCT). The aim of the study is to evaluate the acceptability and feasibility of integrating Home-MCT into cardiac rehabilitation services and to provide provisional evidence of effectiveness and cost-effectiveness on Home-MCT.


Options:
A: Acceptability (From the completion of the manual till 4 months)
B: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)
C: Hamilton Depression Rating Scale (Measured at 16 weeks)
D: Admission to hospital for recurrent CHD event (8 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor
Brief Summary: The purpose of this research study is to determine the best medication to stop preterm labor. Recent studies have identify nifedipine and indomethacin as the two medications that are most likely to delay delivery for 48 hours, decrease maternal side effects and decrease some complications related to preterm delivery to the neonate. Both of these medications are commonly used to stop pre-term labor, therefore it has become our institution's standard to use these two medications in the setting of preterm labor. There have been limited studies comparing these two medications directly.

A total of 450 participants will be asked to participate across all study sites.


Options:
A: Efficacy of MgSO4 as tocolytics : increased interval of uterine contraction, decreased maternal painful sensation, stopping the cervical change (48 hours later)
B: Number of Participants With Preterm Birth (Less than 37 weeks of gestation)
C: Number of Participants With Delay of Preterm Delivery by 48 Hours. (Participants will be followed for the duration of the hospital stay, an expected average of 1 week)
D: Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS)
Brief Summary: The purpose of the study is to assess the efficacy of ravulizumab to control disease activity in children and adolescents with aHUS who have not previously used a complement inhibitor (complement inhibitor treatment-naïve), as well as in complement inhibitor-experienced (eculizumab-experienced) adolescent participants.


Options:
A: The effect of OMS721 as measured by platelet count change from baseline (26 weeks)
B: Percentage Of Complement Inhibitor Treatment-naïve Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26 (Week 26)
C: 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)
D: Percentage Of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26 (Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Obesity in Toddlers (PROBIT): a Randomized Clinical Trial of Primary Pediatric Care From Birth Onwards.
Brief Summary: AIM:

to reduce the prevalence of overweight and obesity at two years of age in the intervention group compared to the control group.

METHODS:

Eleven primary paediatricians were randomized to the intervention group and intensively trained about the trial intervention. Each of them was asked to consecutively recruit the parents of at least 30 newborns taken in charge within the first six months of the study, and to provide them with standardized oral and written information on protective practices during all the well visits scheduled in the first two years of the child's life.

Another eleven primary paediatricians were randomized to the control group, and were asked to consecutively recruit the parents of at least 30 newborns taken in charge within the first six months of the study and to provide them with usual care and follow-up. When all recruited children have completed the second year of life, the two groups of toddlers will be compared as regards the prevalence of overweight/obesity, defined by WHO cut-offs of the weight/length ratio.


Options:
A: Mean weight-for-length z-score at 15 months of age (15 months of age)
B: Weight-for-Length Percentile (Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).); Appetite Regulation (The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).); Fruit and Vegetable Variety (The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).)
C: Frequency of exclusive and total breastfeeding (First year)
D: Body mass index (BMI) at two years of age. (Third year of the study.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students
Brief Summary: Studies show a high number of medical students suffering from mental health problems. Although there are several studies investigating how these problems could impact students' life and performance, few studies have investigated interventions to minimize this distress. One of these interventions is the mindfulness meditation, that has already been extensively studied in the scientific literature showing promising results. Nevertheless, there are very few studies which investigated how mindfulness could be implemented as a mandatory course. The present study aims to investigate (1) how students exposed to mindfulness differ from students not exposed to this technique concerning their mental health and quality of life in a short and long term period. This is an intervention protocol using a randomized controlled clinical trial with cross-over, in order to compare if the implementation of mindfulness for first year medical students will improve their mental health and quality of life in the short term (3 months). The intervention group (group 1) will be exposed to mindfulness in the beginning of the medical course and will be compared to a control group (group 2), not exposed to mindfulness (exposed to theoretical classes) for 3 months. After that, the intervention group (group 1) will receive theoretical classes and the control group (group 2) will be exposed to the mindfulness techniques for 3 months (cross-over). Therefore, both groups will be exposed to mindfulness in the first year of undergraduation, however in different moments of the course. Then, these first year medical students (groups 1 and 2) will be compared to another class (group 3), which didn't have this mindfulness mandatory course in their formation. They will be compared after 6 months, 12 and 24 months of intervention (long-term effect).


Options:
A: Self-reported quit rate for the past 7 days (6-month follow-up)
B: Daily Depression (Change in daily depression assessed daily for seven days during week 2 and week 16 of the study.); Depression I (Change in depression over 4-month period.); Depression II (Change in depression over 4-month period.); Daily Social Connection (Change in daily social connection assessed daily for seven days during week 2 and week 16 of the study.); Daily Belonging (Change in loneliness over 4-month period.); Loneliness (Change in loneliness over 4-month period.)
C: Smoking behavior (6 months)
D: Assess emotional states of depression, anxiety and stress. (At 3 months); Assess emotional states of depression, anxiety and stress. (At 6 months); Assess emotional states of depression, anxiety and stress. (At 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma
Brief Summary: Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA stems from the fact that the disease is glucocorticoid-sensitive and early treatment can prevent progression to end-stage lung disease. Recently anti-Th2 therapies have been suggested as treatment for ABPA. Vitamin D has been shown to suppress the Th2 responses and decrease the levels of Th2 interleukins. Hence, the investigators propose to assess the role of vitamin D in treating ABPA.


Options:
A: serum Vitamin D (3 months)
B: Time to first upper respiratory tract infection (One year); Time to first severe asthma exacerbation (One year)
C: Change From Baseline in Serum 25OHD (During the 7-month follow-up period)
D: Decline in total IgE (Two months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Site Prospective Randomized Controlled Trial Comparing Chlorhexidine Gluconate and Povidone-Iodine as Vaginal Preparation Antiseptics for Cesarean Section to Determine Effect on Bacterial Load
Brief Summary: Primary Hypothesis: chlorhexidine gluconate antiseptic vaginal preparation is superior to povidone-iodine vaginal preparation in decreasing the bacterial load within the vagina when prepping prior to a cesarean section.


Options:
A: Bacterial Load (Immediately Post-operative prior to exit from operating room)
B: Number of cases of endometritis after cesarean section (15 days)
C: Post-intervention Aerobic Bacterial Colony Counts (From intervention to 7 days post); Post-intervention Anaerobic Bacterial Colony Counts (From intervention to 7 days post)
D: Number of Participants With Surgical Site Infection (up to 6 weeks postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Neonatal Supraglottic Airway Trial: A Single-centre, Open-label, Randomized Clinical Trial to Evaluate the Efficacy of I-gel® Supraglottic Airway Used in Neonatal Resuscitation in Reducing Early Neonatal Mortality and Morbidity
Brief Summary: Mortality rates from birth asphyxia in low-income countries remain very high. Face mask ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless supraglottic airway which is easy to insert and provides an efficient seal that prevents air leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can be trained in a short time to use this method. A pilot study in Uganda has demonstrated that midwives can safely perform resuscitation of newborn with the i-gel.

OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to face-mask ventilation during neonatal resuscitation can reduce early neonatal death (before 7 days of life) or morbidity in neonatal encephalopathy (NE) in asphyxiated neonates.

STUDY DESIGN, SETTING AND POPULATION A single-centre randomized clinical trial will be conducted at Mulago National Referral Hospital, Kampala, Uganda, among asphyxiated neonates in the delivery units. Prior to the intervention, all staff in the labour ward performing resuscitation will receive training according to the HBB curriculum with a special module for training on supraglottic airway insertion. Resuscitation will be performed according to international guidelines.

UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not only would reduce mortality, but also the burden of neurological damage in survivors.


Options:
A: Composite outcome of either a) early neonatal death or b) neonatal encephalopathy (Day 7 of life)
B: Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. (Seven days)
C: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
D: Number of Participants Failing to Avoid Invasive Mechanical Ventilation (120 hours)

Answer: A