TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Controlled Trial of Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
Brief Summary: Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone tube) placed in the bladder at the time of operating to monitor kidney function during surgery and in the post-surgery period. Such patients will also have an infusion into the spine, known as an epidural, after surgery to provide them with continuous pain relief. Urinary catheters should be removed as early as possible once they are no longer required to facilitate patients becoming mobile after surgery and to reduce the risk of patients developing a urinary tract infection.

Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.


Options:
A: Post-operative urinary retention requiring re-catheterisation (14 days following urethral catheter removal)
B: time to micturition (first 24 hours after spinal anesthesia)
C: Number of Participants With Void Trial Failure Rate (post-operative day, about 4 hours post-surgery)
D: the subjective pain assessment provided by the patient post-operatively (post operatively day 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-blinded, Active-control and Unblinded Standard of Care (SOC) Controlled Study to Determine the Efficacy and Safety of Targeted Intramyocardial Delivery of Autologous CD34+ Cells (Auto-CD34+ Cells) for Increasing Exercise Capacity During Standardized Exercise Testing in Subjects With Refractory Angina Pectoris and Chronic Myocardial Ischemia
Brief Summary: The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.


Options:
A: Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol (Baseline and 12 month visit)
B: Change in Maximal Oxygen Consumption (VO2max) (Measured at Baseline and Month 6); Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo (Measured at Baseline and Month 6); Change in Reversible Defect Size (Measured at Baseline and Month 6)
C: Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment (6 weeks)
D: Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma
Brief Summary: The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).


Options:
A: To understand the mechanisms driving eosinophilia and disease pathogenesis in patients with a wide range of eosinophilic disorders (Ongoing assessment)
B: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set (Baseline (Day 1), Week 16)
C: Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results (Throughout study or until early discontinuation); Incidence, nature, and severity of adverse events (Throughout study or until early discontinuation)
D: Percentage of Participants With Asthma Exacerbation (Baseline up to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma
Brief Summary: The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).


Options:
A: Percentage of Participants With Asthma Exacerbation (Baseline up to Week 12)
B: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set (Baseline (Day 1), Week 16)
C: Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period (Baseline to end of the fixed-dose steroid treatment period (Week 24)); Percentage of Participants With at Least 1 Adverse Event (Baseline to end of the study (Week 68))
D: adenosine, PC20, forced expiratory volume in one second (FEV1)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
Brief Summary: The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.


Options:
A: Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale (baseline to 6 months); Change in Hand Grip Strength (baseline to 6 months)
B: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)
C: Difference in mean change in joint pain between HA and placebo groups (14 weeks)
D: Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score (12 weeks post-registration)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Brief Summary: In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Options:
A: Lung Clearance Index (90 minutes post treatment)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Hospital Length of Stay (Admission to Discharge)
D: weight of sputum that was expectorated (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Brief Summary: In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Options:
A: Wet sputum production (45 minutes)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight (24 hours)
D: weight of sputum that was expectorated (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Brief Summary: In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Options:
A: weight of sputum that was expectorated (12 months)
B: Mean percentage change in forced expiratory volume in one second (FEV1) (7days)
C: Respiratory muscle endurance (Change from baseline (i.e. T0) measured immediately after the 8 weeks of intervention (T1))
D: Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline Forced Vital Capacity (FVC) at 8 weeks (Eight weeks); Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks (Eight weeks); Change from baseline Peak Expiratory Flow (PEF) at 8 weeks (Eight weeks); Change from baseline maximum inspiratory pressure at 8 weeks (Eight weeks); Change from baseline maximum expiratory pressure at 8 weeks (Eight weeks); Change from baseline distance covered in six-minute walk test at 8 weeks (Eight weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Brief Summary: In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: weight of sputum that was expectorated (12 months)
C: Lung Clearance Index (90 minutes post treatment)
D: Hospital Length of Stay (Admission to Discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Brief Summary: In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Options:
A: Wet sputum production (45 minutes)
B: Mean percentage change in forced expiratory volume in one second (FEV1) (7days)
C: weight of sputum that was expectorated (12 months)
D: Difference in the number of respiratory exacerbations during the 1 year study period (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Brief Summary: In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Options:
A: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
B: weight of sputum that was expectorated (12 months)
C: Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1) (Baseline - immediately post exercise - 45min post exercise)
D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Brief Summary: In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Options:
A: weight of sputum that was expectorated (12 months)
B: Change in lung functions determined at 0,3,6,12,18,24 months; Change in exercise capacity determined at 0,3,6,12,18,24; months; Change in physical activity determined at 0,3,6,12,18,24 months; Change in quality of life determined at 0,3,6,12,18,24 months
C: The six-minute walking distance (0, 1, 2 months)
D: Change in glycemia at 2h of -1.5 mmol/L (baseline and week 13)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial Comparing Morcellation With Electrical Resection for Removal of Uterine Polyps
Brief Summary: Outpatient polyp treatment can be performed in a few different ways but generally involves passing a special type of hysteroscope (3-6 millimetre in diameter) into the womb through which specifically designed miniature operating instruments are passed to remove the polyp(s). At present the most commonly used instruments use an electrical cutting edge. However, a new instrument using a mechanical cutting edge has come to market. In patients having a general anaesthesia the mechanical cutting instrument has been shown to be easier to learn, more effective at completely removing polyps and quicker. However, the instrument is slightly larger, which could potentially cause more discomfort and prolong the procedure in the outpatient setting. Therefore, the investigators want to compare the electrical and mechanical instruments for speed, completeness of polyp removal and patient acceptability.


Options:
A: second diagnostic hysteroscopy (postoperation three to four months)
B: The time taken for polyp removal (at the time of surgery (day 1 intraoperatively))
C: Clinical pregnancy rate (10 month)
D: Visual analogue scale for pain; Patient satisfaction

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomised Trial Comparing the Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence. The ARNS 12249 TasP (Treatment as Prevention) Trial in Hlabisa Sub-district, KwaZulu-Natal, South Africa.
Brief Summary: This trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level.

The proposed strategy is a two steps process:

* Extensive HIV counselling and testing, and comprehensive prevention programme among a target population
* Immediate ART initiation after HIV diagnosis, irrespective of CD4 count criteria.

The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the population. This is a cluster randomised controlled trial with a total of 22 communities used as the units for randomisation. Enrolment of a population of 22 000 individuals among which 4 400 are expected to be HIV-Infected.


Options:
A: Mortality (2 years)
B: Treatment initiation (28 days after study enrollment); Treatment initiation and retention (8 months after study enrollment)
C: Survival (At 36 months)
D: Uptake of initial and repeat HIV counselling and testing (Feasibility phase) (14 months); Uptake of ARV treatment among HIV-infected individuals (Feasibility phase) (14 months); HIV infection incidence (4 years after enrolment initiation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine
Brief Summary: The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.


Options:
A: Number of Participants with Adverse Events as a Measure of Safety and Tolerability" (day 1)
B: Frontal lobe cerebral oxygenation (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour); Foetal heartrate (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour)
C: Incidence of hypotension (Time between induction of spinal anesthesia until delivery)
D: The time required to remain sitting after spinal anesthesia (start with 3 minutes after completion of spinal then we ll go up or down)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine
Brief Summary: The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.


Options:
A: Early Profound Fetal Bradycardia (Within 30 minutes of combined spinal epidural (CSE) placement)
B: The time required to remain sitting after spinal anesthesia (start with 3 minutes after completion of spinal then we ll go up or down)
C: Incidence of hypotension (Time between induction of spinal anesthesia until delivery)
D: Frontal lobe cerebral oxygenation (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour); Foetal heartrate (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
Brief Summary: This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo.


Options:
A: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
B: Continuous abstinence from smoking (Six months post-quit date)
C: Point Prevalence Tobacco Abstinence (Week 12); Point Prevalence Tobacco Abstinence (Week 24)
D: Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment (7 days at end of treatment); Number of Participants Experiencing Treatment-emergent Adverse Events (26 weeks (12 weeks of treatment plus full post-treatment follow-up))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
Brief Summary: This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo.


Options:
A: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
B: Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment (7 days at end of treatment); Number of Participants Experiencing Treatment-emergent Adverse Events (26 weeks (12 weeks of treatment plus full post-treatment follow-up))
C: Anamnestic and biochemical* validated smoking cessation (12 months after inclusion)
D: 30-day point prevalence tobacco abstinence (6 months); Change in weight (6 months)

Answer: B