TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Regular Exercise in Prevention of Excessive Weight Gain in Pregnancy. A Single Blind Randomized Controlled Trial
Brief Summary: Background:

Use of variable definitions of exercise and disparate results, emphasize the need of proper randomized controlled trials examining the relationship between physical activity and weight development during pregnancy. So far, only few intervention studies aiming at weight management during pregnancy have been performed (Gray-Donald et al., 2000,Olson et al., 2004,Polley et al., 2002,Kinnunen et al., 2007). Moreover, most of these interventions have focused on how gestational weight gain may be altered through individual counselling combining diet and exercise habits, rather than supervised training. Search on PubMed revealed no randomized controlled trial where the main outcome was to investigate how the effect of supervised structured exercise may reduce the proportion of women gaining more weight than optimal. The aim of the present study is to assess whether a 12-week aerobic exercise program during pregnancy can prevent excessive gestational weight gain.

Method:

This is a single blind randomized controlled trial to evaluate the effects of a structured, supervised aerobic exercise program on weight gain stabilization in primiparous pregnant women. The aim is to include 100 women. Interested women eligible for the present study will be invited to a pre-test including interview and assessments at the university. The women are examined three times during the study period. The first visit is between 12 and 24 weeks of gestation, the second at week 36-38 and the last 8-12 week after delivery. The exercise program consists of supervised exercise for 60 minutes, performed at least 2 times per week, for 12-16 weeks. Compliance with the training protocol is controlled by the instructors and registrations in the womens personal training diary


Options:
A: Prematurity (Women will be interviewed at hospital soon after birth (up to 2 days after delivering))
B: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)
C: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
D: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study PXN110527: The Investigation of the Efficacy and Pharmacokinetics of XP13512 in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN) Who Have Had an Inadequate Response to Gabapentin Treatment.
Brief Summary: The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.


Options:
A: Change in pain and symptoms (Up to 14 weeks)
B: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data (Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)); Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period (Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period))
C: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
D: Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time (Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study PXN110527: The Investigation of the Efficacy and Pharmacokinetics of XP13512 in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN) Who Have Had an Inadequate Response to Gabapentin Treatment.
Brief Summary: The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.


Options:
A: The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the average daily pain score from the baseline week to the final week of the efficacy treatment period (Treatment Week 10) in patients with PHN; Daily pain scores will be measured using an electronic diary.
B: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data (Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)); Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period (Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period))
C: Alteration of pain intensity after treatment (5 weeks)
D: Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment. (Baseline and Post-randomization Day 22); Number of Participants With Treatment-emergent Adverse Events (Randomization to Post-randomization Day 29 (includes dose reduction))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-Term Study of Physiologic Dialysate Glucose Concentration in Chronic Hemodialysis Patients
Brief Summary: This study aims to show that using a glucose (sugar) concentration of 100 mg/dL in the dialysis fluid for hemodialysis is not inferior to using a concentration of 200 mg/dL with regard to the frequency and magnitude of blood glucose drops. Other parameters that will be compared between the two groups are blood pressure, heart rhythm, weight gain between dialysis treatments, and fatigue after the treatment.


Options:
A: Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment (6 weeks)
B: 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)
C: Change in fatigue severity (Baseline measurements, at the end of 4th week, at the end of 8th week and two weeks after the completion of the interventions.); Change in anxieyt and depression level. (Baseline measurements, at the end of 4th week, at the end of 8th week and two weeks after the completion of the interventions.)
D: Primary outcomes included change in lean body mass measured by dual-energy X-ray absorptiometry, quadriceps muscle cross-sectional area (CSA) measured by MRI, and knee extensor muscle strength.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: EMPOWIR: Enhance the Metabolic Profile of Women With Insulin Resistance: Carbohydrate Modified Diet Alone and in Combination With Metformin or Metformin Plus Avandia in Non-diabetic Women With Midlife Weight Gain and Documented Insulin Elevations (Syndrome W)
Brief Summary: The goal of the study is to identify and treat women with midlife weight gain who have normal blood sugars, but increased insulin levels (hyperinsulinemia) following the performance of a glucose tolerance test. The study will evaluate effects of a unique carbohydrate modified diet alone and in combination with metformin(MF) and Avandamet® (MF plus rosiglitazone (RSG)) on insulin levels in a wide range of ethnically diverse women (aged 35-55) at three academic medical centers. The primary study hypothesis is that insulin sensitizing medications, in combination with alterations in carbohydrate intake, will reduce insulin levels and improve established risk factors for the metabolic syndrome.

The alarming prevalence of obesity, diabetes, and related comorbidities and the paucity of easily adopted, cost-effective preventive strategies for high risk populations, suggest that pharmaco-therapies and dietary regimens targeted to reducing insulin resistance could have important clinical and public health implications.


Options:
A: weight loss at 12 weeks; Fat loss at 12 weeks; Lean mass change at 12 weeks
B: Fasting Insulin (6 months)
C: Change from baseline in weight at 12 months (Baseline and 12 months)
D: body mass index (change from baseline to 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Pre-operative Carbohydrate Loading Reduce Insulin Resistance and Improve Outcomes in Elective Surgical Patients?
Brief Summary: The recent development of an oral carbohydrate drink for consumption prior to elective surgical procedures has been shown to improve insulin sensitivity. However, these studies have not investigated the use of this carbohydrate supplement in patients undergoing cardiac and spinal surgery.

Hypothesis: The administration of 100g of carbohydrates the evening before and 50g of carbohydrates two hours before elective coronary artery bypass graft (CABG) or spinal surgery will reduce postoperative insulin resistance by 40% compared to those undergoing the standard of care of fasting the evening before and the day of surgery.


Options:
A: insulin resistance (Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation)
B: Insulin sensitivity (baseline and postoperatively)
C: Morbidity and mortality after open infrarenal aortic aneurysm repair (2 years)
D: complications until 30 days after surgery according to the zurich classification (30 days postoperative)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-based vs. Supervised Exercise for Claudicants
Brief Summary: The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.


Options:
A: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
B: Six-minute walk distance (Measured at baseline and follow-up study visits); Summary performance score (Measured at baseline and follow-up study visits)
C: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)
D: Maximal treadmill walking distance (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-based vs. Supervised Exercise for Claudicants
Brief Summary: The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.


Options:
A: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain. (6 months)
B: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)
C: maximal walking distance
D: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-based vs. Supervised Exercise for Claudicants
Brief Summary: The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.


Options:
A: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
B: Maximum Walking Distance (MWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)); Pain-free Walking Distance (PFWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)); Functional Walking Distance (FWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months))
C: Change in Six-Minute Walk Performance at 9-month follow-up (change from baseline to month 9)
D: Depression, as assessed the Patient Health Questionnaire-9 (Baseline, Weeks 2-6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega-3 Polyunsaturated Fatty Acids in Women With Major Depressive Disorders During Pregnancy
Brief Summary: Whether high-dose omega-3 fatty acids supplement would be an effective treatment in patients with major depressive disorder during pregnancy and breast-feeding.


Options:
A: Beck Depression Inventory-II (BDI-II) (Change from baseline to 10 weeks (post-treatment))
B: Serum Fasting Blood Sugar(FBS) (Change from baseline at 10 weeks)
C: N/A
D: Percentage of Participants with major depressive episode (for Study 1); Changes in Hamilton Depression Rating Scale (HDRS) (for Study 2) (Weeks 0 to 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega-3 Polyunsaturated Fatty Acids in Women With Major Depressive Disorders During Pregnancy
Brief Summary: Whether high-dose omega-3 fatty acids supplement would be an effective treatment in patients with major depressive disorder during pregnancy and breast-feeding.


Options:
A: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)
B: Persistent wheeze 0 to 3 years of age (3 years)
C: Insulin sensitivity (Measured at approximately Month 3)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega-3 Polyunsaturated Fatty Acids in Women With Major Depressive Disorders During Pregnancy
Brief Summary: Whether high-dose omega-3 fatty acids supplement would be an effective treatment in patients with major depressive disorder during pregnancy and breast-feeding.


Options:
A: N/A
B: 17-item Hamilton Depression Rating Scale (8 weeks)
C: Change in depression ratings (HAMD, SIGH-ADS) (5 weeks)
D: Beck Depression Inventory (6 - 8 weeks postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Milnacipran 100 And 200 MG Daily in Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure
Brief Summary: The study is designed to accurately assess any changes in blood pressure and pulse at 100 and 200 mg daily dose of milnacipran in patients with fibromyalgia syndrome.


Options:
A: Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits (at end of treatment, 15 weeks from baseline assessment)
B: Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 (4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)); Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6 (7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d))
C: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)
D: Pain reduction (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Milnacipran 100 And 200 MG Daily in Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure
Brief Summary: The study is designed to accurately assess any changes in blood pressure and pulse at 100 and 200 mg daily dose of milnacipran in patients with fibromyalgia syndrome.


Options:
A: Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 (4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)); Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6 (7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d))
B: Time to Loss of Therapeutic Response (LTR) (From baseline Visit 3 (week 5) to Visit 7 (week 17))
C: Adverse Events (Baseline (Visit 1) to Week 53 (Visit 9))
D: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?
Brief Summary: We evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. Postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls.


Options:
A: Incidence of Postoperative Nausea and Vomiting (postoperative 24 hours)
B: Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively (within 24h after operation)
C: Prevention of PONV in the 24 hours following end of surgery; Tolerability
D: Nausea (0-72 hours postoperative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?
Brief Summary: We evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. Postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls.


Options:
A: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)
B: Major Perioperative Morbidity (30 day after surgery)
C: N/A
D: Nausea (0-72 hours postoperative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?
Brief Summary: We evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. Postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls.


Options:
A: Pain score by numeric rating scale (At 8 hours postoperatively)
B: Painscore during mobilization (2-24 hours after extubation time.)
C: Nausea (0-72 hours postoperative)
D: Surgical wound infection (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent high-grade glioma.


Options:
A: Evaluation of the treatment impact on progression-free survival (5 years)
B: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)
C: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)
D: 6 Month Progression-free Survival (First day of treatment until progression or until 6 months mark)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Randomized, Multicenter Phase II Study of a Combination of Torisel® (Temsirolimus) and Avastin® (Bevacizumab) Versus Sutent® (Sunitinib) and Versus a Combination of Avastin® (Bevacizumab) and Roféron® (Interferon Alpha-2a) in First-line Treatment of Patients With Metastatic Renal Cell Carcinoma.
Brief Summary: The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal cancer.

Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®, or Sutent® or IFN+Avastin®.


Options:
A: Progression-free Survival (PFS) (From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941).)
B: Anti-tumor Activity as Measured by Median Progression Free Survival Time (24 Months)
C: progression-free rate (at 48 weeks post-treatment)
D: Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants (From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)); Overall Survival (OS) in PD-L1 Positive Participants (From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Randomized, Multicenter Phase II Study of a Combination of Torisel® (Temsirolimus) and Avastin® (Bevacizumab) Versus Sutent® (Sunitinib) and Versus a Combination of Avastin® (Bevacizumab) and Roféron® (Interferon Alpha-2a) in First-line Treatment of Patients With Metastatic Renal Cell Carcinoma.
Brief Summary: The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal cancer.

Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®, or Sutent® or IFN+Avastin®.


Options:
A: Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab (Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.)
B: Overall Survival (OS) at Primary Endpoint (Randomization until 398 deaths, up to May 2015 (approximately 30 months))
C: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
D: progression-free rate (at 48 weeks post-treatment)

Answer: D