TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
Brief Summary: Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.


Options:
A: Venous thrombosis and/or pulmonary embolism (PE) (Postoperative 4 weeks)
B: 30-day Mortality (30 days)
C: Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation (28 days or until hospital discharge, whichever earlier); Venous or Arterial Thrombotic Events: Anti-platelet Therapy Versus No Anti-platelet Therapy (28 days or until hospital discharge, whichever earlier)
D: Rate of invasive mechanical ventilation (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
Brief Summary: Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.


Options:
A: Changes in carotid wall volume as measured by MRI scan (At 40 weeks and 104 weeks)
B: absolute changes in carotid intima-media thickness from baseline to final visit (12 months)
C: Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses (48 heures)
D: Venous thrombosis and/or pulmonary embolism (PE) (Postoperative 4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
Brief Summary: Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.


Options:
A: Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: (through study completion, up to 30 days)
B: Venous thrombosis and/or pulmonary embolism (PE) (Postoperative 4 weeks)
C: Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days. (In 30 days)
D: Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint (Up to Day 35); Number of Participants With Time to First Occurrence of The Principle Safety Outcome (Fatal Bleeding and Critical Site Bleeding) Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Up to Day 35)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
Brief Summary: Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.


Options:
A: Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days. (In 30 days)
B: Venous thrombosis and/or pulmonary embolism (PE) (Postoperative 4 weeks)
C: Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization (Day 30)
D: a composite of acute VTE, arterial thrombosis, treatment with ECMO, or all-cause mortality (30 days from enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of No Treatment Compared With Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants: a Randomized, Double-blind, Placebo-controlled, Non-inferiority Clinical Trial
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of no treatment compared with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm infants. (non-inferiority study)


Options:
A: Ductus diameter mm/kg (at postnatal age of 5 days); Cumulative dosage of morphine (at postnatal age of 5 days)
B: Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA) (36 weeks PMA)
C: 2-year survival without cerebral palsy (2 years)
D: Days Spent on Supplemental Oxygen During the First 28 Days. (28 days of life)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
Brief Summary: The aim is to assess the relative efficacy of S-1 de-escalation therapy vs. continuation of chemotherapy after induction therapy in patients with metastatic esophagogastric cancer in terms of overall survival.


Options:
A: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)
B: Overall Survival (OS) (From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months))
C: Overall Survival (OS) (approx. 12 month)
D: Progression-free Survival (Treatment will continue until disease progression or intolerable toxicity, up to 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester
Brief Summary: The aim of this study is to determine whether the dydrogesterone therapy is associated with reduction in miscarriage in women with first trimester threatened miscarriage. The hypothesis is that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women with threatened miscarriage.


Options:
A: The chance of miscarriage before 20 weeks of gestation (At 20 weeks of gestation)
B: Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination (T1 (20 days); T2 (40 days))
C: Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. (48 hours); Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. (48 hours)
D: Preterm delivery (37 weeks of gestation) (6 mo. after end of recruitment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester
Brief Summary: The aim of this study is to determine whether the dydrogesterone therapy is associated with reduction in miscarriage in women with first trimester threatened miscarriage. The hypothesis is that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women with threatened miscarriage.


Options:
A: The chance of miscarriage before 20 weeks of gestation (At 20 weeks of gestation)
B: The frequency of spontaneous abortion before 28 weeks (14 weeks)
C: Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination (T1 (20 days); T2 (40 days))
D: Ongoing pregnancy rate (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dry Eye Assessment and Management Study
Brief Summary: The objective of the DREAM study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease.


Options:
A: Schirmer tear test (Screening, Week 4, Week 12, Week 24); Ocular Surface Disease Index (Screening, Week 4, Week 12, Week 24); Tear Breakup Time (Screening, Week 4, Week 12, Week 24); Corneal Staining with Fluorescein (Screening, Week 4, Week 12, Week 24); Impression Cytology (Screening, Week 12, Week 24); Conjunctival staining with lissamine (Screening, Week 4, Week 12, Week 24)
B: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L (Single visit); Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm (Single visit); Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds (Single visit); Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 (Single visit); Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 (Single visit); Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 (Single visit); Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 (Single visit)
C: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months (12 months)
D: Symptom severity: symptom questionnaires and clinical dry eye tests (3 months intervention + 1 month after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dry Eye Assessment and Management Study
Brief Summary: The objective of the DREAM study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease.


Options:
A: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)
B: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)
C: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)
D: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population
Brief Summary: This study will assess whether a negative pressure wound vacuum therapy (NPWT) on closed incisions decreases the risk of wound complications among obese patients after cesarean section

All patients having a cesarean section in labor or presenting to the triage unit and requiring a cesarean section will be eligible

Main study intervention: this involves the use of a negative pressure wound vacuum therapy on a closed incision.


Options:
A: Surgical site infection rate (30 days)
B: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)
C: Groin Wound Complication (30 days)
D: Number of Participants With Wound Complications (Four weeks after cesarean section)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population
Brief Summary: This study will assess whether a negative pressure wound vacuum therapy (NPWT) on closed incisions decreases the risk of wound complications among obese patients after cesarean section

All patients having a cesarean section in labor or presenting to the triage unit and requiring a cesarean section will be eligible

Main study intervention: this involves the use of a negative pressure wound vacuum therapy on a closed incision.


Options:
A: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
B: Number of Participants With Wound Complications (Four weeks after cesarean section)
C: Postoperative Surgical Site Infection (SSI) (30 days following operation)
D: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population
Brief Summary: This study will assess whether a negative pressure wound vacuum therapy (NPWT) on closed incisions decreases the risk of wound complications among obese patients after cesarean section

All patients having a cesarean section in labor or presenting to the triage unit and requiring a cesarean section will be eligible

Main study intervention: this involves the use of a negative pressure wound vacuum therapy on a closed incision.


Options:
A: Number of Participants With Wound Complications (Four weeks after cesarean section)
B: Surgical site infection rate (30 days)
C: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
D: Groin Wound Complication (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population
Brief Summary: This study will assess whether a negative pressure wound vacuum therapy (NPWT) on closed incisions decreases the risk of wound complications among obese patients after cesarean section

All patients having a cesarean section in labor or presenting to the triage unit and requiring a cesarean section will be eligible

Main study intervention: this involves the use of a negative pressure wound vacuum therapy on a closed incision.


Options:
A: Post-operative Seroma Formation (Two weeks following drain removal)
B: Number of participants with seroma (3 months)
C: Number of Participants With Wound Complications (Four weeks after cesarean section)
D: Groin Wound Complication (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Abdominal Binders in Patients Undergoing Cesarean Sections: A Randomized Controlled Trial
Brief Summary: To see if the use of Abdominal Binders improves patients out comes after cesarean delivery


Options:
A: Pain, assessed by patients using a pain scale (72 hours or hospital stay)
B: Pain measurement (up to post operateive day 2); Patient Distress score (up to post operateive day 2)
C: The intervention of patient-selected music before and after Cesarean delivery will decrease anxiety levels in a patient population undergoing Cesarean delivery. (Before and after cesarean delivery)
D: Pain score by visual analogue scale (VAS) on movement at 48 hours postoperatively (48 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Dark Chocolate on Blood Pressure in Mildly Hypertensive Individuals
Brief Summary: The evidence linking chocolate with lowered blood pressure has been observed. However, the interventions have been short, at most 4 weeks. The aim of this study is to find out if the habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also, more insight to the mechanisms linking chocolate to individual healt-responses is needed.


Options:
A: Vascular function (Measured at weeks 4 and 12)
B: Changes in systolic and diastolic blood pressure (8 weeks)
C: Changes in endothelial function and blood pressure (within the first 12 weeks of chocolate intake (week 12 and baseline))
D: Endothelial function (Time points: day 0 [baseline], and day 30 each 0 and 2h.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The STOMACH Trial: Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy
Brief Summary: Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological survival. In gastric cancer the role of laparoscopic surgery remains unclear.

Current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield.

Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy.

Results of the STOMACH trial will further aid in determining the optimal surgical technique in patients with gastric cancer.


Options:
A: 5 year disease free survival (1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years)
B: Extent of lymph node dissection (two weeks)
C: noncompliance rate (postoperative 1 week)
D: overall survival

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mixed-method Study to Explore, Assess, and Explain the Translation of a Complex Set of Evidence-based Rules Into Practice Through Electronic Medical Record Based Decision Support: How Can STOPP Effectively be Deployed in Primary Care?
Brief Summary: This mixed methods study seeks to assess and understand the impact of using an advanced CDS tool to present the STOPP criteria to support prescribers at the point of decision-making. We ask the overarching question:

\*\*How can clinical decision support tools effectively translate a complex set of evidence-based rules into primary care clinical practice?\*\*

The work is divided into 2 phases.

PHASE 1: Randomized control trial. We will measure change in potentially inappropriate prescribing by primary care prescribers (e.g. family doctors) who are using the Clinical Decision Support (CDS) tool in their Electronic Medical Record (EMR), as compared to those who are not. Potentially Inappropriate Prescribing is defined by the STOPP criteria, the same criteria that will be used in the clinical decision support tool in the EMR. We will use the OSCAR EMR for this study. EMR based queries will be developed to assess the number of potentially inappropriate prescriptions are current in each of 12 physician practices at baseline and at 16 weeks.

PHASE 2: We will then complete a qualitative follow up with participants to aid in understanding how primary care prescribers perceived the CDS. This will help explain Phase 1 findings and provide additional information to enhance future decision support tools.


Options:
A: Change in rate of potentially inappropriate prescribing (Baseline, 8 weeks, 16 weeks)
B: Rate of colorectal cancer screening
C: N/A
D: rate of potentially inappropriate psychotropic medication (September 2008-July 2010)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Procalcitonin Antibiotic Consensus Trial (ProACT)
Brief Summary: The ProACT study is a 5 year, multicenter study that will test the effect of implementation of a novel procalcitonin guideline on antibiotic use and adverse outcomes in Emergency Department (ED) patients with Lower Respiratory Tract Infection (LRTI).


Options:
A: overall rate of antibiotic prescribing (2 years)
B: Proportion of patients prescribed an antibiotic in each arm (Assessed at day 28 after baseline)
C: Antibiotic prescription rate (24 hours)
D: Total Antibiotic Exposure Days (30 days); Number of Participants With Any Adverse Outcome (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology
Brief Summary: The purpose of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with chronic kidney disease. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured self-regulation program to implement sodium recommendations that are in current guidelines.


Options:
A: C-reactive protein (up to 16 weeks); interleukin-6 (up to 16 weeks); alpha tumor necrosis serum concetrations (up to 16 weeks)
B: Dietary sodium intake as assessed from 3-day recalls. (baseline and 4 months); Dietary sodium effluent and urine concentration. (baseline and 4 months); Morning blood pressure. (baseline and 4 months); Morning post dialysis weight. (baseline and 4 months); Feasibility and acceptability of PDA-based dietary monitoring. (4 months)
C: 24-hourly urinary sodium excretion (up to 9 months)
D: Changes in urinary albumin excretion from baseline at 4 month. (At baseline and 1,2,3 and 4 month.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology
Brief Summary: The purpose of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with chronic kidney disease. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured self-regulation program to implement sodium recommendations that are in current guidelines.


Options:
A: ∆Albuminuria by 24-hour Urine Protein Excretion (changes from week 8 at week 16 (week 8 - week 16))
B: Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 6 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum Phosphourous at 6 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 6 months); Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 12 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum phosphorus at 12 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 12 months)
C: 24 hour blood pressure (Two weeks after start of each intervention)
D: 24-hourly urinary sodium excretion (up to 9 months)

Answer: D