TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Application of Citrate Dialysate in Chronic Haemodialysis
Brief Summary: Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events. It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins.


Options:
A: Occurrence of clinically relevant calcium disturbances (patients are followed for 8 weeks); Occurrence of clinically relevant acid-base disturbances (patients are followed for 8 weeks)
B: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
C: Proportion of participants screened as eligible who enroll (34 months); Proportion of participants who enrolled who completed the 8 week-trial (34 months); Tolerability of Meditation Intervention on a 10-point Likert scale (8 weeks)
D: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first); Time to All-cause Mortality or End Stage Renal Disease (ESRD) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cholecalciferol as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease
Brief Summary: This research is being done to study the effectiveness of vitamin D (cholecalciferol) to modify hepcidin levels in children with chronic kidney disease (CKD). Anemia is a common problem in children with CKD. Anemia is when the body does not have enough healthy red blood cells. Hepcidin is a protein in the blood which interferes with the body's production of red blood cells. This study will see if vitamin D lowers hepcidin levels in children and young adults with CKD. If so, it could be used as an additional treatment for anemia in these children, in addition to the current therapies already in use including iron supplements and erythropoietin. People between the ages of 1 and 21 with CKD may be considered for this study.


Options:
A: Vitamin D plasma concentrations (12 months)
B: Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease (change from baseline to up to three months)
C: Serum concentration of 25(OH) D at 36 weeks postmenstrual age. (36 weeks); Prevalence of vitamin D deficiency at 36 weeks postmenstrual age. (36 weeks)
D: Maternal and Neonatal complications (six months post enrolement)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen
Brief Summary: This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).


Options:
A: Period 1: Clinical and Endoscopic Remission (Week 8); Period 2: Clinical Response, Open-Label Extended Induction (Week 16); Period 3: Clinical Remission (Week 38)
B: Number of Participants Who Achieved Clinical Remission at Day 56 (Baseline up to Day 56)
C: Rate of clinical remission
D: Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal (7, 14, 21, 28, 56 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen
Brief Summary: This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).


Options:
A: Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) (6 months)
B: Period 1: Clinical and Endoscopic Remission (Week 8); Period 2: Clinical Response, Open-Label Extended Induction (Week 16); Period 3: Clinical Remission (Week 38)
C: Fecal Calprotectin Level <50µg/g (6 weeks after randomization)
D: Number of Participants Who Achieved Clinical Remission at Day 56 (Baseline up to Day 56)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: BPH-6: A UroLift® System Post Market Multi-Center Randomized Study
Brief Summary: The purpose of this study is to compare the UroLift System Treatment to Transurethral Resection of the Prostate (TURP) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.


Options:
A: Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met (Month 12)
B: Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up (3 Month Follow-up Visit); Safety: Device Related Serious Complications (3 Months)
C: Collection of Post-treatment Catheterization for Safety (Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days); Comparison of IPSS for Efficacy (3 month); Mean UroLift Improvement in IPSS at 12 Months (12 months)
D: The prevalence of lower urinary tract symptoms using ICS 2002 symptom definition (At enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy
Brief Summary: The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.


Options:
A: Percent change from baseline in "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2 to 12, compared to baseline)
B: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
C: Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8 (Baseline to between Weeks 2 to 8)
D: The Primary Measure of Efficacy Was the Percent Change in the "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12. (Weeks 2-12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Perineal Protection Device
Brief Summary: Objective:

To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.

Design:

A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.

Main outcome measures:

The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.


Options:
A: Number of patients with perineal tears (perineal tears are evaluated within 1 hour of delivery)
B: Perineal rupture grade III-IV (anal sphincter tears) (At delivery - within minutes - hours of randomization)
C: Grade I and II rupture during delivery (time at the delivery department (up to 12 months))
D: Episiotomy procedures (until completed the second stage of labour, about from 30 min to 24 h)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Perineal Protection Device
Brief Summary: Objective:

To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.

Design:

A multicenter randomized control trial performed at three hospitals in Sweden, in Helsingborg, Lund and Malmö. Participants recruited are women with vaginal delivery (N=1200), cephalic presentation. They will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal.

Main outcome measures:

The effect on the frequency and extension of perineal ruptures grade I, II and anal sphincter rupture are measured.


Options:
A: Perineal rupture grade III-IV (anal sphincter tears) (At delivery - within minutes - hours of randomization)
B: PERINEAL LACERATION Primary outcome: 1. Perineal laceration - present or absent (1 hour postpartum)
C: Incidence of Perineal laceration - any degree (at the time of delivery)
D: Grade I and II rupture during delivery (time at the delivery department (up to 12 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Based Management of Fast Breathing in Infants Aged < 60 Days: A Double-Blind, Randomized Placebo-Controlled Trial in Low-income Settlements of Karachi
Brief Summary: The aim of the study is to determine optimal management of isolated fast breathing in young infants in a trial design conducted in primary care settings.

The investigators hypothesized that proportion of infants who fail therapy will be 4% in each group. A 6% or less difference in failure rate will be considered equivalent.


Options:
A: Primary outcome is reduction in Infant Mortality less than six months of age (2 years)
B: Treatment failure (Day 8 of enrollemnt)
C: Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for presumed pneumonia. (March 2013 - November 2014 (8 months)); Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for diarrhea (March 2013 - November 2014 (8 months)); Percentage of change in number of children under five in intervention area who receive Integrated Community Case Management Treatment from a Community Health Worker for fever. (March 2013 - November 2014 (8 months))
D: Number of death in children aged 6 to 59 months (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, 5 Treatment Arms, 4-period, Incomplete Cross-over Study to Determine the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) (2.5 / 5 µg; and 5 / 5 µg) (Delivered by the Respimat® Inhaler) Compared With Tiotropium (5 µg), Olodaterol (5 µg ) and Placebo (Delivered by the Respimat® Inhaler) on Lung Hyperinflation and Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD) [MORACTO TM 1]
Brief Summary: The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD


Options:
A: Trough Forced Expiratory Volume at 1 Second (FEV1) (12 weeks)
B: Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks); Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks)
C: Exercise Tolerance Comparison Between QVA149 and Placebo Groups (3 weeks)
D: FEV1 AUC0-3h Response (baseline and 12 weeks); Trough FEV1 Response (Change From Baseline) (baseline and 12 weeks); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study (12 weeks treatment); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352 (12 weeks treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, 5 Treatment Arms, 4-period, Incomplete Cross-over Study to Determine the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) (2.5 / 5 µg; and 5 / 5 µg) (Delivered by the Respimat® Inhaler) Compared With Tiotropium (5 µg), Olodaterol (5 µg ) and Placebo (Delivered by the Respimat® Inhaler) on Lung Hyperinflation and Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD) [MORACTO TM 2]
Brief Summary: The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD.


Options:
A: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169. (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.); Trough FEV1 Response on Day 170. (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) (Day 169)
B: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)
C: Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks); Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks)
D: Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity (6 weeks); Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Acceptance & Commitment Therapy for Smoking Cessation (Aka PATH Study - Partnering to Achieve Tobacco-free Health)
Brief Summary: The overall aim of this 5-year project is to capitalize on the strong theoretical and promising empirical evidence for Acceptance \& Commitment Therapy (ACT) as an intervention for smoking cessation by comparing the effectiveness of ACT against standard cognitive behavioral therapy (CBT) counseling when both are offered with nicotine replacement therapy (NRT) and delivered within a real world healthcare setting.


Options:
A: Professional identity (We will measure the score of professional identity before intervention and immediately after intervention.); Career self-efficacy (We will measure the score of career self-efficacy before intervention and immediately after intervention.)
B: Number of Participants With Smoking Abstinence (4 weeks post quit day (one week following the end of treatment)); Smoking Abstinence (26 weeks post quit day); Smoking Abstinence (4 weeks post quit day (one week following the end of treatment))
C: Number of Participants Who Stopped Smoking by 12 Month Post Treatment (12 months)
D: Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI) (Week 8 and 20)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)
Brief Summary: This is a prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real world patient population with hypertension GSR DEFINE is the continuation of the Global SYMPLICITY Registry and collectively will enroll approximately 5000 patients with hypertension who undergo the renal denervation procedure, from over 300 sites worldwide. Subjects included in GSR DEFINE will be followed for a minimum of 1 year and up to 5 years post-procedure. Patients with uncontrolled hypertension will be enrolled in accordance with the inclusion criteria specified in the protocol.


Options:
A: BP Measurements (6 months)
B: Office Systolic Blood Pressure Reduction (Baseline to 6 months)
C: Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (From baseline to 6 months post-procedure)
D: Freedom of AF or other atrial arrhythmias (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial
Brief Summary: This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.


Options:
A: The effect of uterine size or posture on IUD insertion. (Day 1)
B: Pain (immediately after LNG-IUS insertion (approx 1 sec))
C: Change in Pain From Baseline to IUD Insertion (change in pain score from baseline (before IUD insertion) to time of IUD insertion)
D: Mean Pain Score During IUD Insertion (Day 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mesalazine and/or Lactobacillus Casei in Maintaining Remission of Symptomatic Uncomplicated Diverticular Disease of the Colon: a Double-blind, Double-dummy, Placebo-controlled Study
Brief Summary: This is a multi-centre, randomised, double blind, double-dummy, parallel groups, placebo-controlled trial was conducted in a population of patients suffering from symptomatic uncomplicated diverticular disease in order to investigate which is the best treatment in preventing relapses of the disease.

Patients were randomly divided in double-blind fashion in one of the following groups:

Group A. Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month;

Group B. Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 placebo, 2 tablets/day for 10 days/month;

Group C. Active mesalazine 800 ng, 2 tablets/day plus Active Lactobacillus casei, 1 sachet/day for 10 days/month;

Group D. Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month.

The main objective was to assess the safety and the efficacy of mesalazine and/or Lactobacillus casei in maintaining remission of symptomatic uncomplicated diverticular disease


Options:
A: discharge without complications +/- antibiotic therapy (Within 30 days after discharge)
B: Global Symptom Score (GSS) at Week 12, Primary Efficacy Population (12 Weeks)
C: diverticulitis relapse (24 months)
D: Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy
Brief Summary: Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh.

Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.


Options:
A: Overall complication rates at eight weeks and the odds of complications, adjusted for study site, body mass index, and hernia type (Eight (8) weeks post-operatively)
B: Pain (1 measurement, 2nd postoperative day)
C: compare mid and long term results in terms of hernia recurrence (3 years after surgery)
D: Assessment of postoperative pain (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation of Bupivacaine, EXPAREL(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)
Brief Summary: This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospital costs.


Options:
A: Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores (through 96 hours)
B: Total Opioid Burden (Wound closure to time hospital discharge order written or Day 30, whichever is sooner); Health Economic Benefits (Wound closure to Day 30)
C: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours (0 to 72 hours)
D: Total Opioid Burden (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Total Cost of Hospitalization (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefits - Length of Stay (LOS) (Wound closure at time hospital discharge order is written or Day 30, whichever is sooner)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Structured Non-operative Treatment of Knee Osteoarthritis - a Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up
Brief Summary: The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis.

The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment at the primary endpoint, which is follow-up 12months after the start of the treatment.

See statistical analysis plan available under "Links" for further description of the study.


Options:
A: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
B: Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score) (Primary: 12months.)
C: ‡Pain Normalized Score (8 weeks)
D: Lequesne Index

Answer: B