TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Isolated Atrial Fibrillation Ablation in Patients With Isolated Atrial Flutter
Brief Summary: Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has a high success rate (5). It has been recognized that patients with typical atrial flutter often complain of atrial fibrillation (1,2). Current clinical and experimental studies confirm the close relationship between atrial flutter (AFL) and atrial fibrillation (AF) and raise a question, if both arrhythmias are different forms of a common electrical phenomenon with atrial fibrillation being the underlying clinical problem (6).


Options:
A: Number or patients with a recurrence of any atrial arrhythmia (2 years)
B: The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) (The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.); The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events (Within 7 Days of Ablation Procedure)
C: Recurrence of Atrial Fibrillation (One year)
D: Freedom from AF (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit
Brief Summary: Respiratory failure requiring endotracheal intubation occurs in as many as 40% of critically ill patients. Procedural complications including failed attempts at intubation, esophageal intubation, arterial oxygen desaturation, aspiration, hypotension, cardiac arrest, and death are common in this setting. While there are many important components of successful airway management in critical illness, the maintenance of adequate arterial hemoglobin saturation from procedure initiation until endotracheal tube placement is paramount as desaturation is the most common factor associated with peri-intubation cardiac arrest and death. Interventions that either shorten the duration of time required for tube placement or prolong the period before desaturation may be effective in improving outcome. The high rate of complications and the lack of existing evidence regarding the efficacy of current airway management techniques in shortening the time to airway establishment or prolonging the time to desaturation mandates further investigation. The primary hypothesis is that video laryngoscopy will be superior to direct laryngoscopy in successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) of medical ICU patients by Pulmonary/Critical Care Medicine fellows after controlling for the operator's past number of procedures with the equipment used. Also, the investigators hypothesize that the provision of apneic oxygenation during the endotracheal intubation procedure (defined as a nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure) will result in a higher arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) compared to no apneic oxygenation.


Options:
A: Reintubation (within 72 hours after extubation or at ICU discharge)
B: Severe desaturation as defined by a pulse oxymetry below 80% (through five minutes after preoxygenation period)
C: to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask. (4 minutes)
D: Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. (1 hour); Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death). (1 hour)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Analysis of the Directional Spread of Geographic Atrophy (GA) in Patients With Age-related Macular Degeneration (AMD)
Brief Summary: Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrial countries. In the late stages of the disease, neovascular changes or the development of geographic atrophy (GA) may induce severe visual loss. GA is characterized by the development of areas of outer retinal atrophy with continuous spread over time that is corresponded to an visual field defect for the patient. The pathogenesis is still incompletely understood. Despite the break-through in the treatment of neovascular AMD by intravitreally administrated vascular endothelial growths factor (VEGF) inhibitors, there is yet no treatment available to slow down or halt the disease process in GA. We and others have demonstrated that the total GA area progression shows large differences between patients. Potential factors influencing differential progression have been intensely studied: While neither systemic nor genetic factors have been shown to influence GA progression, ocular characteristics such as GA baseline size or phenotypic features of fundus autofluorescence (FAF) abnormalities have been identified as risk characteristics for increased GA progression. While these previous studies have mainly focused on the characterization of total GA area progression, topographic directional spread has not been analyzed and relevant predictive markers are yet unknown. There may be large differences in the local GA progression. The primary objective of this study is to identify specific characteristics, for the local GA progression. The knowledge of such risk factors may help to better understand the pathogenesis of GA. The identification of predictive markers will allow for better prognostic assessment of the individual disease process. The DSGA study is the extension trial of the FAM (Fundus Autofluorescence in Age-related Macular Degeneration) study (NCT00393692).


Options:
A: Change of geographic atrophy size to baseline (24 months)
B: N/A
C: Least Square (LS) Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12 (Baseline (screening) and Month 12.); Number of Subjects With Treatment Emergent Adverse Events (TEAEs) in the Study Eye, Including by Severity (From the time of first study drug administration (Day 1) up to Month 12 (Data cut-off date).)
D: RT-PCR for influenza A virus in nasal secretion (2 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Analysis of the Directional Spread of Geographic Atrophy (GA) in Patients With Age-related Macular Degeneration (AMD)
Brief Summary: Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrial countries. In the late stages of the disease, neovascular changes or the development of geographic atrophy (GA) may induce severe visual loss. GA is characterized by the development of areas of outer retinal atrophy with continuous spread over time that is corresponded to an visual field defect for the patient. The pathogenesis is still incompletely understood. Despite the break-through in the treatment of neovascular AMD by intravitreally administrated vascular endothelial growths factor (VEGF) inhibitors, there is yet no treatment available to slow down or halt the disease process in GA. We and others have demonstrated that the total GA area progression shows large differences between patients. Potential factors influencing differential progression have been intensely studied: While neither systemic nor genetic factors have been shown to influence GA progression, ocular characteristics such as GA baseline size or phenotypic features of fundus autofluorescence (FAF) abnormalities have been identified as risk characteristics for increased GA progression. While these previous studies have mainly focused on the characterization of total GA area progression, topographic directional spread has not been analyzed and relevant predictive markers are yet unknown. There may be large differences in the local GA progression. The primary objective of this study is to identify specific characteristics, for the local GA progression. The knowledge of such risk factors may help to better understand the pathogenesis of GA. The identification of predictive markers will allow for better prognostic assessment of the individual disease process. The DSGA study is the extension trial of the FAM (Fundus Autofluorescence in Age-related Macular Degeneration) study (NCT00393692).


Options:
A: N/A
B: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 (At the end of month 24)
C: N/A
D: Change of geographic atrophy size to baseline (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Core Stability Exercises on Abdominal Deep Muscles in Colorectal Cancer Survivors
Brief Summary: The purpose of this study is to determine the effects of physical training program to improve deep stabilizer muscle in colorectal cancer survivors


Options:
A: Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer. (3 months)
B: Abdominal isometric endurance (Baseline- 8 weeks)
C: Physical activity questionnaire (International Physical Activity Questionnaire) (Baseline and 6 months)
D: Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition. (Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Core Stability Exercises on Abdominal Deep Muscles in Colorectal Cancer Survivors
Brief Summary: The purpose of this study is to determine the effects of physical training program to improve deep stabilizer muscle in colorectal cancer survivors


Options:
A: Feasibility of Patient Recruitment to Yoga Intervention (10 weeks)
B: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
C: Abdominal isometric endurance (Baseline- 8 weeks)
D: Whether the PA and dietary intake targets are met at the end of intervention; (at the end of 12 months of intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Single-Blind, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Intravenous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) for the Prevention of Angioedema Attacks in Children 6 to 11 Years of Age With Hereditary Angioedema
Brief Summary: Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).

Secondary Objectives - To assess the safety and tolerability, characterize the pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.


Options:
A: Normalized Number of Angioedema Attacks Per Month in a Treatment Period (From start of treatment up to 12 weeks during each treatment period)
B: Frequency of All HAE Attacks (Duration of the study)
C: Number of Confirmed HAE Attacks (Investigators collected data from patient diaries from the first day of dosing through to Day 29 or last day of dosing +24 hrs (the effective dosing period).); Proportion of Subjects Who Were HAE Attack-free During the Entire Dosing Period (Investigators collected data from patient diaries from the first day of dosing through to Day 29 or last day of dosing +24 hrs (the effective dosing period).)
D: Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period (First injection up to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-Dialysis Patients
Brief Summary: The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.


Options:
A: US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population) (Baseline (Day 1, Week 0), Week 28 to 52); Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population) (Baseline (Day 1, Week 0) up to Week 24)
B: Responder rate: proportion of responders among the subjects (Week 30 to 36)
C: Maximum Change From Baseline in Hb During Weeks 3-13 (Baseline, Weeks 3-13)
D: Mean Hemoglobin (Hb) change from baseline to average levels from Week 28 to Week 52. (Minimum of 52 weeks and maximum of up to 3 years after last subject is randomized); Proportion of subjects who achieve a Hb response during the first 24 weeks of treatment. (Week 0 to Week 24); The incidence of cardiovascular and cerebrovascular events within 52 weeks. (Week 0 to Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Childhood Obesity Prevention Program: Building Better Families and Communities
Brief Summary: This study is proposed on behalf of the Hartford Childhood Wellness Alliance, a 107 member, 35 group organization whose goal is to improve the health of children in Hartford, CT. In a randomized control trial, the primary aim of this study is to test the initial efficacy of a program of enhanced home visitation with neighborhood and community support to change maternal behaviors related to infant nutrition (sweetened beverage/juice consumption, breastfeeding and introduction of solids), parenting skills (establishing routines around sleep, reading cues for hunger, satiety, television time) and family wellness (improving the home food environment, enhancing physical activity). The investigators hypothesize that at 12 months of age, infants in the intervention arm will drink less sugar sweetened beverages/juices, will have ingested solids at an older age, will have been breastfed longer and more exclusively than infants in the control arm and will have less TV viewing, more established sleep routines and greater soothability (primary outcomes).


Options:
A: Change child body mass index z-score. (Baseline, end of program, 6 month follow up)
B: Number of months of breast feeding (6 and 12 months)
C: Body Mass Index Z-Score (Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008)
D: Change in Fruit and Vegetable Consumption at School Lunch (assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May).); Change in Student Activity Level (assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Childhood Obesity Prevention Program: Building Better Families and Communities
Brief Summary: This study is proposed on behalf of the Hartford Childhood Wellness Alliance, a 107 member, 35 group organization whose goal is to improve the health of children in Hartford, CT. In a randomized control trial, the primary aim of this study is to test the initial efficacy of a program of enhanced home visitation with neighborhood and community support to change maternal behaviors related to infant nutrition (sweetened beverage/juice consumption, breastfeeding and introduction of solids), parenting skills (establishing routines around sleep, reading cues for hunger, satiety, television time) and family wellness (improving the home food environment, enhancing physical activity). The investigators hypothesize that at 12 months of age, infants in the intervention arm will drink less sugar sweetened beverages/juices, will have ingested solids at an older age, will have been breastfed longer and more exclusively than infants in the control arm and will have less TV viewing, more established sleep routines and greater soothability (primary outcomes).


Options:
A: Number of months of breast feeding (6 and 12 months)
B: Change in Infant Growth (Baby is less than 2 months; baby is 3 months; baby is 6 months)
C: Growth (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months); Hemoglobin (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months)
D: HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (24 months of age); Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Building Capacity for Specialized Services Through eConsultation
Brief Summary: The consultation-referral process is complex, involving several steps including 1) the PCP recognizing the need for specialist advice/intervention, 2) patient agreement on seeing the specialist, 3) referral letter and information sent to specialist, 4) appointment booked and communicated, 5) patient visit(s) with the specialist and 6) communication back to the PCP.

There are many factors during this process which limit the effectiveness and efficiency of patient care. These include inequitable access for patients and providers, long wait times before specialist advice received/implemented, delayed communication and mismatched consult expectations. These gaps result in significant breakdowns in transitions of care, inappropriate treatment, patient dissatisfaction and potential harm. Moreover, not all individuals are willing or able to travel to see specialists in a large academic medical centre even when recommended by the PCP.

Electronic consultation (eConsult) service is a form of asynchronous communication whereby primary care providers (PCP) and specialists can communicate directly about a patient through a secure web-based application. eConsult has the potential for improving transitions in care through improved communication ensuring that patients are seen by the right specialist, when necessary, with the right information and in a timely manner. The goal of this project is to evaluate the impact of eConsult on specialist referral rates using health administrative data.


Options:
A: healing time for leg ulcer and/or diabetes related foot ulcer (one year)
B: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)
C: Relative dose intensity (Assessed every 30 days from randomization up to 6 months)
D: Specialist referral rate per 100 patients seen (to medical specialties available through eConsult) (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adventitious Lung Sounds as Indicators of Severity and Recovery of Lung Pathology and Sputum Location
Brief Summary: This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in patients with lower respiratory tract infection (LRTI).

Patients will be recruited from a central Hospital and their demographic and anthropometric data, lung sounds, lung function, breathlessness, oxygen saturation and chest HRCT scan will be collected within 24h of the first appointment. Then, patients will be randomly allocated to either conventional treatment or conventional treatment plus respiratory physiotherapy. Conventional treatment will consist on daily medical treatment prescribed by the physician. Respiratory physiotherapy will involve 9 sessions (3 times a week during 2 weeks) of breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.

It is expected that ALS will be responsive to changes in patients' lung function after treatment. It is also expected that, by including a respiratory physiotherapy component in the treatment of patients with LRTI, they will express more improvements in a shorter period of time.


Options:
A: Change in adventitious lung sounds (24 hours after hospital presentation (baseline) and 3 weeks after intervention)
B: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (Median 2.7 years/Average 2.6 years)
C: Severity-weighted Total Days of ARI Illness (8 months)
D: Severity-adjusted total days of acute respiratory infection (ARI) illness, as self-reported on the Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number) of cold flu episodes and total unadjusted days of illness will also be reported. (2009-2010 cold season)

Answer: A