TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Day 3 vs Day 5 Embryo Transfer for Patients With Low Embryo Numbers Going Through in Vitro Fertilization (PILOT STUDY)
Brief Summary: The purpose of this small-scale pilot study (10 patients) is to test the study protocol for an RCT comparing IVF outcomes between day 3 and day 5 embryo transfer in patients with five or fewer embryos in a fresh embryo transfer in vitro fertilization (IVF) cycle. Information derived from this RCT would allow us to maximize the chances of success for these patients undergoing IVF.


Options:
A: cumulative live birth rate of a single PGD treatment (1 year)
B: Live birth rate (up to 24 weeks)
C: live birth (9 months)
D: Pregnancy rate (8 weeks after inclusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Blood Cell Transfusion Decision Based on Arterial-venous Oxygen Difference Can Reduce Mortality in Critically Ill Patients
Brief Summary: Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU course. The optimal management red blood cells RBC transfusion in critically ill patients remains controversial and clinical studies in this field have usually been based on transfusion thresholds. In the "TRICC" Trial, patients assigned to a restrictive transfusion strategy (transfusion if Hb\<7 g/dL) had similar mortality to patients transfused if Hb\<10 g/dL. Notably, none of the large RCT tried to focus on a personalize RBC transfusion protocol, i.e. a transfusion protocol which address the individual need for transfusion basing on physiological approach. We therefore hypothesized that patients with high extraction of oxygen could benefit more of RBCs transfusion regardless their hemoglobin levels.


Options:
A: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)
B: 90-day mortality (after 90 days from study enrollment)
C: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
D: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma
Brief Summary: This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.


Options:
A: Rate of Asthma Exacerbations Per Year (monthly through study completion an average of 15 months)
B: Number of Participants With a Severe Asthma Exacerbation Event (From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.)
C: Number of exacerbations (one year)
D: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Nutritional Supplement of Probiotics and/or Prebiotics vs Placebo on Serum Concentrations of Uremic Toxins and Inflammatory Cytokines in Automated Peritoneal Dialysis Patients.
Brief Summary: End-stage renal disease (ESRD) is a world public health problem, with high morbidity and mortality. Cardiovascular disease is the main cause of mortality in ESRD; uremic toxin retention and inflammation are considered non-traditional risk factors, as they have an active role in atherosclerosis and vascular calcification pathogenesis in dialysis patients.

Uremic toxins may be generated by internal protein metabolism, however, some toxins that can't be efficiently eliminated by dialysis such as indoxyl sulphate and p-cresyl sulphate (protein bound toxins), are generated by the microbial metabolism in the large intestine by proteolytic bacteria, and may diffuse easily through the intestinal lumen, as a leaky gut characterizes kidney disease.

The gut has been recognized as a potential source of inflammation in ESRD patients; accumulation of nitrogen compounds, presence of gastrointestinal symptoms, dietary changes and multiple drugs and supplements use, stimulates microbiota alterations as bacterial overgrowth and translocation. These phenomena, may active the immune system, promoting local and systemic inflammation, which in turn has negative effects increasing endothelial dysfunction, muscle catabolism, insulin and erythropoietin resistance, and decreases appetite.

Some methods have been proposed to decrease inflammation and uremic toxin accumulation, as more efficient dialysis and anti-inflammatory drugs; however, some of them have limited efficacy and high cost. Nutritional treatments focused on modifying intestinal environment, as pre- and probiotics have promising effects by altering production and absorption of uremic toxins and decreasing inflammation; nevertheless, there is scarce information regarding its use and their role in ESRD, particularly in peritoneal dialysis, which is a widely used therapy in México. Furthermore, there is no clinical study comparing the effectiveness of prebiotics, probiotics, and symbiotics on serum concentrations of uremic toxins and inflammation in ESRD patients. It is possible that the administration of a nutritional supplement of probiotics and/or prebiotics decreases the serum concentrations of uremic toxins and inflammation markers in ESRD patients on automated peritoneal dialysis compared to placebo.


Options:
A: Hb A1c (3 months)
B: Highly sensitive C-reactive protein (hs CRP) level (4 weeks); Total anti-oxidant capacity (4 weeks); Blood urea level (4 weeks)
C: Change in weight (Baseline and 6 months); Change in fat free body mass (Baseline and 6 months); Change in serum albumin concentration (Baseline and 6 months); Change in serum prealbumin concentration (Baseline and 6 months)
D: Change of uremic toxins from basal to 1 and 3 months (Baseline, 1 month and 3 months); Change of uremic toxins from basal to 1 and 3 months (Baseline, 1 month and 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: One Plus One Equals Two - Will That do? A Randomized Controlled Trial to Evaluate Collegial Midwifery Practice to Prevent Perineal Trauma
Brief Summary: A new clinical practice to reduce perineal trauma has been adopted by many maternity wards in Sweden. This practice involves collegial midwifery assistance during the second stage of labor and the birth of the baby. The midwife responsible for the birth is the primary carer of the woman and the second midwife observes the birth or assists the primary midwife if asked to. The hypothesis is that the presence and support of an extra midwife will reduce severe perineal trauma (trauma to the anal sphincter (OASI)).

The objective of this trial is to evaluate whether collegial midwifery assistance during the second stage reduces perineal trauma grade III-IV.


Options:
A: Grade I and II rupture during delivery (time at the delivery department (up to 12 months))
B: Incidence of Perineal laceration - any degree (at the time of delivery)
C: Number of women with obstetric anal sphincter injury (4 hour)
D: Perineal rupture grade III-IV (anal sphincter tears) (At delivery - within minutes - hours of randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Decision Making and Patient Engagement Program During AECOPD Hospitalization
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Patients require good communication with the physician to improve control illness. Shared decision making is a promising opportunity for chronic disease management due to the relative cost, medicine optimization and decreases hospital admissions/re-admissions


Options:
A: Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources. (14 months)
B: Health related quality of life (Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)
C: Evaluation of effects (T1: Initial evaluation; T2: after three months; T3: one year after T1)
D: Follow-up with primary care provider (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ontario Healthcare Implementation Laboratory: A Learning Health System Approach That Leverages Data to Improve Quality in Primary Care: Stage 1
Brief Summary: Antibiotic overuse occurs in multiple jurisdictions and is associated with rising rates of antimicrobial resistance. Mailing letters to the highest antibiotic prescribing physicians is a potentially effective method to optimize antibiotic use. The objectives of this study are to improve enrollment to Health Quality Ontario's Primary Care Practice report and reduce unnecessary antibiotic use. The investigators are conducting a randomized controlled trial recruiting the 3500 highest antibiotic prescribing primary care physicians in Ontario. The investigators have incorporated behavioural science theory into designing letters to modify prescribing behaviour. Letter 1 is testing change ideas related to antibiotic initiation and letter 2 is testing change ideas related to antibiotic duration. There will be 1500 physicians receiving letter 1, 1500 receiving letter 2, and 500 will serve as controls. Twelve months later all 3500 physicians will receive a letter.


Options:
A: Proportion of patients receiving any antibiotic (2 weeks)
B: Total Antibiotic Exposure Days (30 days); Number of Participants With Any Adverse Outcome (30 days)
C: The proportion of recruited patients prescribed an antibiotic (6 Days)
D: Antibiotic prescribing rate (12 months); Prolonged duration prescribing rate (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study
Brief Summary: Catheter ablation (CA) has been reported to reduce risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) in retrospective studies, but risk and benefit of CA has not been well elucidated in NVAF with recent cerebral infarction in prospective randomized trials.


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: Absence of thromboembolic events 48 hours post-ablation (48 hours)
C: Clinically significant hematoma (defined as hematoma requiring reoperation and/or transfusion and/or unplanned or prolonged hospitalization and/or interruption of LMWH or IV heparin or oral anti-coagulant. (Device implant until first routine post-op visit)
D: Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure. (Up to 6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction (DANBLOCK)
Brief Summary: To determine whether long-term treatment with oral betablocker therapy after myocardial infarction in patient with no heart failure reduces the composite outcome of recurrent MI, all-cause mortality, revascularisation with percutaneous coronary intervention or coronary artery bypass graft, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest.


Options:
A: A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, malignant ventricular arrhythmia, or resuscitated cardiac arrest. (Estimated follow-up min 6 months - max 6.25 years)
B: Occurrence of myocardial infarction,stroke or cardiovascular death.
C: Time to death of any cause, or time to readmission because of AMI, ischemic stroke or heart failure (Time to event from the date of enrollment through study completion, an average of 4 years.)
D: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preoperative Locally Applied Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse: Changes in Subjective and Objective Outcome - a Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study
Brief Summary: Introduction With increasing age the incidence of pelvic organ prolapse (POP) rises and will increase substantially in the future according to forecasting studies. It is possible that oestrogens, alone or in combination with other forms of therapy, may assist in the management of POP by increasing collagen synthesis and thereby improving the strength of the weakened vaginal epithelium. Yet, studies investigating the effect of topical oestrogen and its impact on POP associated symptoms, both self-reported improvement and observations of objective improvement, are lacking.

Objective To evaluate the subjective efficacy concerning prolapse associated complaints measured by the German pelvic floor questionnaire (domain POP: POP-score) after preoperative use of local oestrogen compared to preoperative placebo treatment in postmenopausal women with symptomatic pelvic organ prolapse. Further variables of interest are POP-score after 3 months, differences regarding the objective prolapse quantification system (POP-Q), surgical outcome and tissue operability assessed by the surgeon.

Methods In this prospective, randomized, double-blind, placebo-controlled, multicenter study the investigators aim to include 120 postmenopausal women with symptomatic pelvic organ prolapse and indicated operative procedure. An analysis of covariance will be computed with the depending variable POP-score after 6 weeks and the independent variables group (verum versus placebo) and Pop-Score at baseline.


Options:
A: Patient satisfaction (At 6 months from study enrollment); Patient satisfaction (At 12 months from study enrollment)
B: Number of Patients With Bacterial Vaginosis at 3 Months (3 months)
C: subjective prolapse associated symptoms (measured with the validated German pelvic floor questionnaire) (change from baseline POP Score at 6 weeks after treatment)
D: Evaluate the histopathological effects on endometrium after each treatment (48 days); Compare the endometrial thickness measured by ultrassound after each treatment (48 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Influence of Home Physical Training Program and Respiratory Rehabilitation on Quality of Life, Body Composition, and Function of Respiratory Muscles in Patients With Primary PAH, HFREF and IHD
Brief Summary: The aim of the study is to evaluate the influence of physical training and respiratory rehabilitation performed by patients at home on quality of life, symptoms, physical endurance, force of respiratory and skeletal muscles and body mass composition in patients with pulmonary arterial hypertension (PAH) or left ventricular heart failure with reduced ejection fraction - HFREF), or ischemic heart disease and evaluation the number of stem cells, natural lymphoid cells and distribution of subpopulations of monocytes (including proangiogenic monocytes) in examined persons and evaluation of theirs eventual influence of the course of disease.


Options:
A: Functional exercise capacity (Oxygen consumption measurement during test) (6 weeks)
B: Clinical improvement assesment of 6 MWT distance (6 months)
C: Pre and post exercise training CPET (10 wks); Accelerometry-based activity (10 wks); 6 minute walk distance (10 wks); Quality of life and functional measures (10 wks)
D: Change in the 6-minute walking distance (after 3 weeks and after 15 weeks compared to baseline.); Quality of life (SF-36) (baseline and 15 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients Treated With Hemodialysis (PEARL-HD)
Brief Summary: The purpose of this study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD). The study objective is to determine if patiromer administered orally once a day with breakfast or lunch will reduce episodes of hyperkalemia in ESRD study participants who receive thrice-weekly HD.


Options:
A: Exponential Rate of Change in Serum Potassium (S-K) Values During the Initial 48 Hours of Study Drug Treatment (From 0 to 48 hours.)
B: Number of episodes of serum K ≥ 5.5 mEq/L (4 weeks)
C: Percentage of Responders (Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.); Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data (Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.)
D: Difference in the Exponential Rate of Change in Serum Potassium (S-K) Levels Versus Placebo During the Initial 48 Hours of Study Drug Treatment (24 and 48 hours post first study drug dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial
Brief Summary: Stress among healthcare professionals is well documented. Untreated stress can lead to anxiety, depression, substance use, and suicide. The use of mindfulness-based programs to reduce stress and enhance wellbeing, among health care professionals, has increased with promising results. Typical mindfulness-based programs are 30 hours in length across 9 sessions. The purpose of this study is to assess the effectiveness of a shorter and more practical program that could be offered during work hours to health care professionals at the NIH Clinical Center. The program will be delivered in five weekly 1.5 hour sessions.


Options:
A: stress levels (75 days)
B: Patients' unplanned urgent visits to the health care system. (30 days after discharge)
C: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
D: Perceived Stress Scale (PSS) (Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial
Brief Summary: Stress among healthcare professionals is well documented. Untreated stress can lead to anxiety, depression, substance use, and suicide. The use of mindfulness-based programs to reduce stress and enhance wellbeing, among health care professionals, has increased with promising results. Typical mindfulness-based programs are 30 hours in length across 9 sessions. The purpose of this study is to assess the effectiveness of a shorter and more practical program that could be offered during work hours to health care professionals at the NIH Clinical Center. The program will be delivered in five weekly 1.5 hour sessions.


Options:
A: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
B: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
C: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)
D: Perceived Stress Scale (PSS) (Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial
Brief Summary: Stress among healthcare professionals is well documented. Untreated stress can lead to anxiety, depression, substance use, and suicide. The use of mindfulness-based programs to reduce stress and enhance wellbeing, among health care professionals, has increased with promising results. Typical mindfulness-based programs are 30 hours in length across 9 sessions. The purpose of this study is to assess the effectiveness of a shorter and more practical program that could be offered during work hours to health care professionals at the NIH Clinical Center. The program will be delivered in five weekly 1.5 hour sessions.


Options:
A: Borderline Symptom Checklist (BSL-23) (Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment)
B: Perceived Stress (3 months post-intervention)
C: Parasuicidal behaviour (intermittent)
D: Perceived Stress Scale (PSS) (Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial
Brief Summary: Stress among healthcare professionals is well documented. Untreated stress can lead to anxiety, depression, substance use, and suicide. The use of mindfulness-based programs to reduce stress and enhance wellbeing, among health care professionals, has increased with promising results. Typical mindfulness-based programs are 30 hours in length across 9 sessions. The purpose of this study is to assess the effectiveness of a shorter and more practical program that could be offered during work hours to health care professionals at the NIH Clinical Center. The program will be delivered in five weekly 1.5 hour sessions.


Options:
A: Perceived Stress (3 months post-intervention)
B: Changes in PTSD symptoms(PCL) (Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat); Probable PTSD diagnosis(CAPS) (Four months after combat)
C: Rate of participant recruitment (1 year); Rate of retention (1 year); Completeness of data entry (1 year); Cost of interventions (1 year); Unexpected costs (1 year)
D: Perceived Stress Scale (PSS) (Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))

Answer: D