TrialPanorama/Dataset huggingface dataset:
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: Hospital mortality (during hospitalization)
C: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)
D: Reduction in the decline of muscle force during the exacerbation. (discharge Day 9)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis
Brief Summary: A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.


Options:
A: attack number (1 year)
B: The time to first documented relapse (months 4, 6, 9, 12, and every 3 months from months 18-39)
C: Evaluate safety of BHT-3009 alone and when combined with atorvastatin in patients with multiple sclerosis.; Determine dose of BHT-3009 and regimen for phase II testing.
D: number of MRI contrast enhancing lesions (treatment months 6 to 9 compared to baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects With Type IIb Dyslipidemia With Residual Risk in Addition to Atorvastatin Therapy (FIRST) Trial
Brief Summary: The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.


Options:
A: To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis.
B: The time to first occurrence of a major cardiovascular disease event
C: Changes from baseline in USPIO-enhanced MRI signal in carotid plaques at 6 weeks and 12-weeks in low and high dose atorvastatin groups (within groups' comparison).
D: Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT) (Baseline, 6 months, 12 months, 18 months, and 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency
Brief Summary: This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) \< 30 mL/min) for a period of 24 weeks.


Options:
A: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) (Baseline , Week 24)
B: Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment (24 weeks)
C: Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 (Baseline, week 18)
D: Proteinuria (at baseline and after 6 and 12 mo of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Remote Orthopedic Outpatient Consultation by Help of Telemedicine
Brief Summary: Patients from 4 local communities in northern Norway referred (either new or follow up) to orthopaedic department, University hospital of Northern Norway for outpatient consultation, are randomly assigned to either remote consultation by use of telemedicine (camera and screen), or standard consultation at the hospital. There are x-ray facilities also at the remote site. The patients randomized to telemedicine consultation meet special trained nurses at the remote site, but doctor only by video conference. The patients will be followed for up to one year. The primary endpoint is quality of care achieved with the telemedicine consultation as compared to standard outpatient consultation (assessed by questionnaires filled out by the doctor involved). Secondary end points are patient satisfaction assessed by questionnaires and economic analyses. The study hypothesis is non-inferiority of telemedicine consultation vs. conventional, outpatient consultation.


Options:
A: Efficacy data: change in HbA1c, measured at 1 year minus the value baseline (one year)
B: Proportion of Participants that Receive Annual Eye Exam (Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study))
C: Intervention-related adverse events (1 day)
D: Safety and quality of health care (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years
Brief Summary: The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity \& safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.


Options:
A: Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) (At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)); Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) (At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)); Number of Subjects With Any Solicited Local Symptoms. (During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration); Number of Subjects With Any Solicited General Symptoms. (During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration); Number of Subjects With Any Unsolicited Adverse Events (AEs). (During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)); Number of Subjects With Serious Adverse Events (SAEs) (From Day 0 through Day 182 and through Day 379.); Number of Subjects With Medically Attended Events (MAEs) (From Day 0 through Day 182 and through Day 364.)
B: 1.Variations in INR value and in OAT weekly dosage after IV
C: Requirements For Drug Registration & Guide Principles For ClinicaL Trial Techniques of Vaccine e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
D: Incidence ratio for acute MI (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Study of NY-ESO-1 Overlapping Peptides With or Without Immunoadjuvants Montanide and Poly-ICLC Vaccination of Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer Patients in Second or Third Remission
Brief Summary: This was a Phase 1, open-label study of repeated vaccination with NY-ESO-1 overlapping peptides (OLP4) with or without the immunoadjuvants Montanide and polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (poly-ICLC) administered every 3 weeks for a total of 5 vaccinations in subjects with epithelial ovarian, fallopian tube, or primary peritoneal cancer in second or third clinical remission. Study objectives included determination of the safety and immunogenicity following vaccination.


Options:
A: Progression-free Survival (Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks))
B: Occurrence of adverse events (side effects) (12 weeks (1 cycle of study treatment))
C: Overview of Treatment-emergent Adverse Events (TEAEs) (Continuously for up to 16 weeks)
D: Selection of better dose level based on the confirmed tumor response.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).


Options:
A: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)
B: Survival without major amputation (6 months after implantation)
C: Therapy Success (6 months)
D: Safety of Intramuscular Injection of CD34-positive cells (6 months and 1 year); Change in Rest Pain (6 months); Ulcer Healing (6 months); Functional Improvement (6 months); Limb Salvage (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RESOLUTE-III All-comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention
Brief Summary: The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, all comers" study.

Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.


Options:
A: The primary end point was target lesion revascularization (TLR) at 1-year follow-up (1 year)
B: Target Lesion Failure (12 months)
C: Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year. (1 year)
D: Major adverse cardiac events (MACEs) in the overall population, defined as the composite of cardiac death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 months (30 days, 6 months, 1,2 and 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions
Brief Summary: The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize that women who receive a paracervical block of combined ketorolac and lidocaine will experience less pain during the procedure based on a visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a paracervical block with lidocaine alone.

This randomized, multi-site, placebo-controlled clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical block with lidocaine alone. A total of fifty women who are seeking elective surgical abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore, Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during, and after surgical abortion will be measured using a 100-mm VAS.

The primary outcome of interest is the mean difference in pain level from preoperative baseline to time after cervical dilation comparing the treatment groups. If the investigators see greater pain reduction associated with the paracervical block of lidocaine and ketorolac, adoption of this regimen may improve pain management during first trimester surgical abortions. If combined ketorolac and lidocaine when administered as a paracervical block is proven to be efficacious, the need for additional analgesia in first trimester surgical abortions can be minimized.


Options:
A: Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure (5 minutes)
B: Subject Perception of Pain and Anxiety During Uterine Aspiration (at time of uterine aspiration (30-60 minutes after premedication))
C: Visual Analog Pain Score for Mean Maximum Procedural Pain (Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure)
D: Level of Pain During Specific Time Intervals Throughout D&C Procedure. (Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure)

Answer: D
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: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)
B: Body mass index of the offsprings (0-24 postpartum months); Fetus body composition (0-24 postpartum months); Change from baseline in Maternal gestational weight gain (40-42 weeks of gestation); Changes in Baby motor development (0-24 postpartum months); Recovery time to pre-gestational weight (6-12 postpartum months); Glycemia level of the offsprings (0-24 postpartum months); Postpartum depression (0-12 postpartum months); Change from baseline in Body image satisfaction (up to 36 weeks); Changes from baseline in maternal quality of life (up to 36 weeks); Placenta measurements (At delivery)
C: Acceptability of the iball intervention (via qualitative data collection) (16 weeks)
D: UI reduction (12 months)

Answer: A
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: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
B: Mean number of incontinence episodes (Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline)
C: Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) (baseline to 12 weeks)
D: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)

Answer: D
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: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
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: Primary outcome: meeting the postpartum weight goal (through 12 months postpartum)
D: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)

Answer: B