TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Hypocaloric Isonitrogenous Nutrition and Epidural Analgesia: a Novel Strategy to Induce Anabolism After Surgery
Brief Summary: Loss of muscle mass and body protein are the main causes of fatigue after bowel surgery, which may result in a longer hospital stay and a higher rate of complications. This particularly applies to malnourished patients with cancer who undergo surgery with less muscle protein reserves than patients who are well-nourished. Anesthesiologists can favourably influence these undesirable consequences of surgery by choosing the type of pain treatment, i.e. analgesia. Our group recently observed that pain treatment with epidural catheters (these are placed in the so called epidural space, which lies between the spine and the skin of the back), in contrast to the more conventional use of intravenous morphine, can prevent the loss of body protein after surgery.

The goal of the present research program is to study whether this protein sparing effect of epidural analgesia can be further augmented if we feed our patients intravenously with glucose and protein starting the day prior to surgery. We believe that this new concept will not only avoid the increased protein loss after surgery, but will also help patients to build up new protein which is needed to fight the stress caused by the operation.


Options:
A: Change in Insulin Sensitivity (Percent) (Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).)
B: Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) (Number of hours post surgery)
C: Morbidity and mortality after open infrarenal aortic aneurysm repair (2 years)
D: protein balance (two days after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical Cancer
Brief Summary: The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.


Options:
A: Disease free survival (5 years from surgery)
B: Number of lymph nodes (After aortic lymphadenectomy is completed)
C: Number of harvested lymph nodes (2 years)
D: Subjective assessment of pain on the morning of post-operative day 1 (One day (the day after surgery))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical Cancer
Brief Summary: The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.


Options:
A: Estimate the Sensitivity of the Sentinel Lymph Node (3 years)
B: Disease free survival (5 years from surgery)
C: Detection and false negative rates of sentinel node (During the surgery (hysterectomy))
D: Overall Survival (time from randomization until death)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical Cancer
Brief Summary: The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.


Options:
A: Duration of Surgery (after surgey)
B: Operative Time (1st 24 hours)
C: Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy (6 Weeks)
D: Disease free survival (5 years from surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.
Brief Summary: The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.


Options:
A: To evaluate the number of patients who reach target blood pressure (BP) and; LDL-C targets as defined by their governing guidelines.
B: Trough Seated Diastolic Blood Pressure (DBP) Control (End of study (34 weeks or last value on treatment))
C: Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy (End of trial follow-up); Change in blood pressure (End of trial follow-up); Change in LDL cholesterol (End of trial follow-up)
D: Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure (Baseline, Week 6 and Week 10.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Prospective, Randomized Controlled Trial for the Detection of Colon Polyps and Predicting Histology
Brief Summary: In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp histology compared to high definition colonoscopy and standard colonoscopy.

Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy, high-definition white light colonoscopy and NBI.

Specific Aim 2 - To compare the number of adenoma detected per subject by standard colonoscopy, high-definition white light colonoscopy and NBI.

Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface mucosal and vascular patterns during the procedure.

Specific Aim 4 - To determine the inter-observer agreement between investigators for the recognition of various polyp patterns


Options:
A: The prevalence of adenomas in the three arms of the study. (2 years)
B: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.; The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.; The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).
C: Neoplasm Miss Rate (same day)
D: adenoma detection rate (number of polyps/number of patients examined) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study Evaluating the Effects of a Structured Lifestyle Intervention on Daily Physical Activity Level of COPD Patients in the First, Second and Third Echelon.
Brief Summary: Chronic Obstructive Pulmonary Disease (COPD) is increasing in the Netherlands. COPD is characterized by a deterioration of lung function, a lowering physical activity level and a low state of quality of life.

The aim of this randomized controlled study is to investigate the effects of a structured lifestyle program compared with usual care (in the first, second and third echelon) on the physical activity level of COPD patients.

150 COPD patients (GOLD I-IV) will be included, aged between 40 and 80 years. In each echelon 25 patients will participate in a structured lifestyle program and 25 patients will be treated with usual care.

In the structured lifestyle program, patients will be stimulated individually to enhance a physically active lifestyle. The primary outcome parameter is daily physical activity (steps/ day) assessed with a pedometer.

According to the study protocol patients in the experimental group and the control group participate in four measurement sessions distributed over 15 months. In each assessment a physical fitness test, lung function and questionnaires are taken. Patients of the experimental group participate in five individual counseling sessions and one telephonic counseling.


Options:
A: Change in impact of COPD in daily life (Baseline and 3 months after baseline)
B: number of steps per day (6 months)
C: Airtrapping in COPD patients (At baseline (time 0 week)); Airtrapping in COPD patients (At 16th week); Airtrapping in COPD patients (At 52th Week)
D: Daily physical activity in steps counts a day (Experimental group: assessment during first 3 months, 2 week assessment at 6 months, 9 months and 15 months. Control group: 2 weeks assessment at baseline, 3 months, 9 months and 15 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study Evaluating the Effects of a Structured Lifestyle Intervention on Daily Physical Activity Level of COPD Patients in the First, Second and Third Echelon.
Brief Summary: Chronic Obstructive Pulmonary Disease (COPD) is increasing in the Netherlands. COPD is characterized by a deterioration of lung function, a lowering physical activity level and a low state of quality of life.

The aim of this randomized controlled study is to investigate the effects of a structured lifestyle program compared with usual care (in the first, second and third echelon) on the physical activity level of COPD patients.

150 COPD patients (GOLD I-IV) will be included, aged between 40 and 80 years. In each echelon 25 patients will participate in a structured lifestyle program and 25 patients will be treated with usual care.

In the structured lifestyle program, patients will be stimulated individually to enhance a physically active lifestyle. The primary outcome parameter is daily physical activity (steps/ day) assessed with a pedometer.

According to the study protocol patients in the experimental group and the control group participate in four measurement sessions distributed over 15 months. In each assessment a physical fitness test, lung function and questionnaires are taken. Patients of the experimental group participate in five individual counseling sessions and one telephonic counseling.


Options:
A: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)
B: Hospital Readmission (12 months)
C: Daily physical activity in steps counts a day (Experimental group: assessment during first 3 months, 2 week assessment at 6 months, 9 months and 15 months. Control group: 2 weeks assessment at baseline, 3 months, 9 months and 15 months)
D: disease-specific health-related quality of life (HRQoL) (two years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin Compared With Placebo in Adult Patients With Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) With an Additional 40-week, Randomized, Double-blind, Placebo-controlled Long-term Observational Period.
Brief Summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.


Options:
A: Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (From randomisation to individual end of trial date (maximum patient year observation: 2.75 years))
B: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Baseline, Week 24)
C: Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) (Baseline , Week 12 (LOCF))
D: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Observational, Retrospective, Comparative Study to Investigate Differential Outcome on Cardiomyopathy Following Control of Acromegaly After Surgery or Somatostatin Analogues Given as First-Line Therapy
Brief Summary: A direct comparison between the results of surgery or somatostatin analogues (SSA) on cardiovascular complication in acromegaly has never been performed.

Our objective is to investigate whether first-line surgery or SSA have a different outcome on cardiomyopathy after 12 months. The design of the study is retrospective, comparative, non randomized, because of ethical problems.

Setting University Hospital. All patients treated with SSA \[either octreotide-LAR (10-40 mg/q28d), or lanreotide (30-120 mg/q28d); dosages up-titrated to control GH and IGF-I levels\] or operated on by transsphenoidal approach. For the purposes of this study only controlled patients will be included.

Measurements Primary outcome measures were changes in left ventricular mass index (LVMi), diastolic \[early to atrial mitral flow velocity (E/A)\] and systolic perform-ance \[LV ejection fraction (LVEF)\]. Secondary outcome measures were reduction of total/HDL-cholesterol ratio, as a cardiovascular (CV) risk parameter, improvement of glucose profile and pituitary function, as indirect causes of CV improvement.

Expected results: SSA and surgery groups should have similar results in terms of improvement of cardiomyopathy. However, recent data suggest that SSA reduce directly heart rate and cardiomyocytes performance: clinical implications of these evidences suggest that SSA will improve cardiovascular outcome more than surgery. Moreover, after surgery, replacement therapy already stabilised or of new onset, has never been considered so far in this setting.


Options:
A: Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments (12 months)
B: Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 (12 months)
C: Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. (At 24 weeks)
D: Changes of left ventricular mass index (LVMi), as measure of LV hypertrophy, early to atrial mitral flow velocity (E/A), as measure of diastolic function, and left ventricular ejection fraction (LVEF), as measure of systolic function. (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control
Brief Summary: This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[FEV1\]) over the full 24-h time period


Options:
A: The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (Up to 52 weeks); Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 (Weeks 12, 26, 36, 44 and 52); Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 (Weeks 12, 26, 36, 44 and 52)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85) (24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85))
C: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12) (From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84))
D: Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo (After 14 days of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V).

To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V).


Options:
A: remission rate (month 6)
B: Remission rate (2006-2008)
C: To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN (18 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization
Brief Summary: This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.


Options:
A: Ongoing Pregnancy Rate at the End of the Study (10 weeks after treatment start)
B: Ongoing pregnancy rate (12 weeks)
C: Number of Bleeding Episodes (Up to year)
D: Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy (8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control
Brief Summary: The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.


Options:
A: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24); Trough FEV1 Response at Week 24 (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.); Mahler Transitional Dyspnea Index Focal Score at 24 Weeks (Baseline, Week 24); Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis (Baseline, Week 24)
B: 24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment (23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period)
C: Exercise tolerance (3 weeks)
D: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control
Brief Summary: The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))
B: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
C: 24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment (23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period)
D: morning peak expiratory flow rate (PEFR) (50 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Effect and Tolerability of Atorvastatin Versus Placebo in Patients With Pulmonary Hypertension: Double-blinded, Randomised, Prospective Phase II Study for 6 Months With Adjusted Doses of Atorvastatin
Brief Summary: Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary Hypertension: double-blinded, randomised, prospective phase II study for 6 months with adjusted doses of Atorvastatin


Options:
A: Myopathy frequency (Measured every other week); Arm isokinetic force at 60 degrees per second (Measured at Month 6); Leg isokinetic force at 60 degrees per second (Measured at Month 6); Handgrip isometric force (Measured at Month 6); Leg dynamic endurance (Measured at Month 6); Maximal aerobic power (Measured at Month 6)
B: Thrombin generation (8 weeks)
C: N/A
D: The placebo-corrected change from baseline to week 24 in 6-minute walk distance (Measured at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Controlled Trial to Evaluate Fast Track Recovery in Elective Open Infrarenal Aortic Aneurysm Repair
Brief Summary: Fast track programs have been introduced in many surgical fields to minimize postoperative morbidity and mortality. Morbidity after elective open infrarenal aneurysm repair is as high as 30%, mortality ranges up to 10%. In terms of open infrarenal aneurysm repair no randomized controlled trials exist to introduce and evaluate such patient care programs.


Options:
A: Morbidity and mortality after open infrarenal aortic aneurysm repair (2 years)
B: complications until 30 days after surgery according to the zurich classification (30 days postoperative)
C: Safety parameters reflecting pathophysiological functions of the liver (day -1, 0, 1, and 7); Gastrointestinal tolerance (day 0 before and 6-8h after surgery); Metabolic parameters in serum, liver and muscle tissue (on day -1, 0, 1, and 7)
D: PTK activity and PI3K, PKB, GLUT4 expression in rectus abdominis muscle samples by the end of operation (1 month (postoperative period))

Answer: A