TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Placebo Controlled Randomised Study of Aramchol on Liver Triglyceride in Patients With Steatosis Due to NAFLD or NASH
Brief Summary: Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol versus the placebo arm following three month treatment.

Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol and the placebo arms.


Options:
A: The difference between initial and final liver triglyceride concentration (measured by NMRS) comparing the Aramchol and placebo treated patients. (3 months)
B: Change in Liver Fat as Measured by MRI-PDFF (Baseline, 24 weeks)
C: Major Cardiovascular Events (5 years)
D: Change of liver fat content measured by magnetic resonance spectroscopy (MRS) (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women
Brief Summary: A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.


Options:
A: Objective cure as defined by the cough test at one year from surgery (one year)
B: Comparison of the cure rates between the mini sling and classical transobturator tapes (Up to one year)
C: Subjective cure rate (compared to results of TVT)
D: to assess efficacy between tot with minisling in cure in women with stress urinary incontinence (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of the Paracervical Block for Pain Control in First Trimester Surgical Abortion
Brief Summary: Many woman undergoing a surgical abortion receive a paracervical nerve block for pain reduction, in which lidocaine (a numbing medication) is injected around the cervix. These injections numb the cervix and possibly the lower part of the uterus. However, the injection can be uncomfortable and it is not well known whether it is effective in reducing pain. The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that paracervical block might have on that pain.


Options:
A: Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale (At time of cervical dilation, 30 minutes after lidocaine administration)
B: Pain reported with cervical dilation (1 Year)
C: Aspiration Pain (Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds))
D: Pain Scores on the Visual Analog Scale (Three months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Comparison of Postoperative Pain and Recovery Between Single Incision Laparoscopic Cholecystectomy Using One Port and Standard Laparoscopic Cholecystectomy Using Four Ports
Brief Summary: Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result, reduced postoperative pain, shorter hospital stay and rapid return to normal activity. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, especially for planned day case procedures.

Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same umbilical incision. The single incision laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and safe by several studies.

The purpose of the study is to compare postoperative pain and operating time, nausea, vomiting, tissue damage, pulmonary function, cosmetic result, quality of life between SILS and standard laparoscopic cholecystectomy.


Options:
A: Postoperative Quality of Life (QoL) (one month)
B: Cosmesis, body image and quality of life scale (at 1 month)
C: Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test. (3-6 weeks)
D: Postoperative pain (24h)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery
Brief Summary: The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.


Options:
A: Event-free Survival Rate (12 months); Primary Patency (12 months)
B: angiographic binary re-restenosis (12 months)
C: Event-free Survival (6 months)
D: Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA) (12 months or at Target Lesion Revascularization (TLR) time); Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients (12 months); Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
Brief Summary: This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for female urinary stress incontinence.


Options:
A: Subjective Cure of Urinary Incontinence at 12 Months After Surgery (12 months)
B: Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence. (1 year)
C: Subjective cure rate (compared to results of TVT)
D: Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes. (Up to one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter,Double Blind,Controlled With Placebo Trial About Efficacy of Statin Association With Standard Treatment in Prevention of Recurrent Hemorrhage in Patient With Liver Cirrhosis and Variceal Bleeding
Brief Summary: This is a prospective, double blind controlled trial in which patients with esophagic variceal bleeding treated with standard therapy (endoscopic variceal ligation(EVL) + B-blockers), will be randomized to receive statins or placebo. They will be followed up during 12 months to determinate whether statins are effective in prevention of variceal bleeding recurrence and evaluate patient survival.

Randomization will be stratified according to the degree of hepatic insufficiency, assessed by the Child-Pugh classifications (A,B or C).


Options:
A: Recurrence of variceal bleeding and patient survival (12 months)
B: recurrence rate of variceal hemorrhage (Participants will be followed for up to 6 months starting from the date of randomization.)
C: Survival (10 years)
D: Survival (10 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior or Panuveitis Requiring Immunosuppression (INSURE Study)
Brief Summary: This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.


Options:
A: Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier. (baseline to 28 weeks)
B: Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline (Baseline to 24 weeks)
C: Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment (Baseline to week 24); Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment (24 weeks)
D: Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months) (6 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of Two Different Doses of the Subcutaneous Administration of an Immunotherapeutic Vaccine, DPX-0907 in Advanced Stage Patients With Ovarian, Breast or Prostate Cancer
Brief Summary: To determine the safety and immunogenicity profile of two (2) different doses of the vaccine DPX-0907 to treat breast, ovarian and prostate cancer.


Options:
A: To determine the safety profile of two different doses of subcutaneously administered DPX-0907. Safety assessments will be based on reported adverse events and the results of vital sign measurements, physical examinations, and clinical laboratory tests. (On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period)
B: Occurrence of adverse events (side effects) (12 weeks (1 cycle of study treatment))
C: Selection of better dose level based on the confirmed tumor response.
D: Progression-free Survival (Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Quit and Win Contests to Improve Smoking Cessation Among College Students
Brief Summary: Standard Quit and Win contests, in which smokers typically quit for one month in return for the opportunity to win prizes, are simple and easy to implement and may be cost-effective in encouraging smokers to quit. By extending contest length and enhancing counseling content, Quit and Win contests may be more effective at encouraging smoking abstinence.

This study aims to evaluate the efficacy of extended and content-enhanced Quit and Win contests to enhance smoking abstinence at college campuses.


Options:
A: Biologically confirmed tobacco cessation (6 months)
B: Smoking Behavior (Self-report Confirmed by Expired Breath CO) (8 week follow up); Urinary Cotinine (8 week follow-up)
C: smoking quit rate change from baseline at 3-month follow-up (3-month follow-up); smoking quit rate change from baseline at 6-month follow-up (6-month follow-up)
D: Efficacy of extended versus standard quit and win contests (6 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Quit and Win Contests to Improve Smoking Cessation Among College Students
Brief Summary: Standard Quit and Win contests, in which smokers typically quit for one month in return for the opportunity to win prizes, are simple and easy to implement and may be cost-effective in encouraging smokers to quit. By extending contest length and enhancing counseling content, Quit and Win contests may be more effective at encouraging smoking abstinence.

This study aims to evaluate the efficacy of extended and content-enhanced Quit and Win contests to enhance smoking abstinence at college campuses.


Options:
A: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
B: Efficacy of extended versus standard quit and win contests (6 Months)
C: Smoking Status (at week 48)
D: Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by Exhaled carbon monoxide (CO) (After 8 weeks); Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in Total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (Baseline, Week 8, Week 12); Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in self-report of daily cigarette and e-cigarette use (Daily from Week 2 to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Interest of Angiotensin-converting Enzyme Inhibitors on Early Sickle Cell Renal Disease in Children. A Randomized, Double-blind Trial Enalapril vs Placebo.
Brief Summary: Patients with sickle cell anaemia may develop renal disease. In fact, renal disease occurred in 40% of adults patients (macroalbuminuria) with evolution to end-stage renal disease for half of them. Microalbuminuria is an early and sensitive marker of glomerular damage. It appears during the first decade and occurred in 20 to 25% of infants (2 to 18 years). Physiopathology of renal scarring is not well understood actually. Renal scarring might be due to glomerular hyperfiltration and vascular and endothelial damage. Angiotensin-converting enzyme inhibitors (ACE) were studied and used in diabetic nephropathy. In a study on 26 sickle cell adults, albuminuria was reduced about 50% by ACE compared to placebo after six months treatment. It might be interesting studying ACE efficacy in sickle cell children with microalbuminuria because renal disease is directly related to sickle cell and is not influenced by other cardiovascular risk factors like in adult patients.

We hypothesized to have a successful ACE treatment in more than 40% of cases after a nine months treatment period. A success is defined as a 50% reduction of the albuminuria/creatinuria ratio.


Options:
A: Percentage of successful treatment of each arm (at 9 months of treatment)
B: urinary albumin excretion rate (12 months)
C: DNA damage from hydroxyurea therapy-variable-diversity-joining (VDJ) recombination events defined as the number of events per microgram of genomic DNA; (Every 3 years); DNA damage from hydroxyurea therapy-percentage of HJB in immature (CD71+) erythrocytes (Every 3 years)
D: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Acupuncture in Chronic Migraine: A Randomized Controlled Trial
Brief Summary: The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment compared with pharmacologic treatment in patients with chronic migraines.Besides, the investigators tested whether the clinical effects of acupuncture in chronic migraine prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).


Options:
A: N/A
B: Mean monthly number of headache days with moderate or severe intensity (3 months)
C: number of days with migraine (4 weeks); frequency of migraine attacks (4 weeks)
D: frequency of migraine attacks (16th week after inclusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Chiropractic and Exercise for Low Back Pain in Adolescents
Brief Summary: Recent research has confirmed that low back pain (LBP) is a significant health problem not only for adults, but also for children and adolescents. Given the enormous social and economic costs associated with LBP, it is critical that attempts be made to decrease the burden of LBP for patients and society.

The primary aim of this project is to determine the relative clinical effectiveness of 3 months of chiropractic care and supervised exercise versus supervised exercise in 184 adolescents with sub-acute recurrent, or chronic LBP. Relative effectiveness will be evaluated in the short, intermediate and long term using pain as the primary outcome measure. Secondary aims are to assess group differences in patient self-reported disability, quality of life, perceived improvement, satisfaction, activity levels, lumbar dynamic motion, and trunk muscle endurance. Patients' and caregivers' perceptions of treatment using qualitative interviews will also be assessed.


Options:
A: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)
B: PATIENT-RATED LOW BACK PAIN (3 and 12 months)
C: Number of recurrences during the follow-up period. (2 1/2 year)
D: walking economy at completion of the exercise program; PEAK power, muscular endurance, and subjective function at completion of the exercise program

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Chiropractic and Exercise for Low Back Pain in Adolescents
Brief Summary: Recent research has confirmed that low back pain (LBP) is a significant health problem not only for adults, but also for children and adolescents. Given the enormous social and economic costs associated with LBP, it is critical that attempts be made to decrease the burden of LBP for patients and society.

The primary aim of this project is to determine the relative clinical effectiveness of 3 months of chiropractic care and supervised exercise versus supervised exercise in 184 adolescents with sub-acute recurrent, or chronic LBP. Relative effectiveness will be evaluated in the short, intermediate and long term using pain as the primary outcome measure. Secondary aims are to assess group differences in patient self-reported disability, quality of life, perceived improvement, satisfaction, activity levels, lumbar dynamic motion, and trunk muscle endurance. Patients' and caregivers' perceptions of treatment using qualitative interviews will also be assessed.


Options:
A: Feasibility and retention (8 weeks)
B: Change in Level of Adherence in Subjects (Objective Measure) (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement (Baseline, 3 months, 6 months)
C: Change in Functional Disability (Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
D: PATIENT-RATED LOW BACK PAIN (3 and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Diets Targeting Energy Density and Energy Restriction on Weight Loss and Feelings of Deprivation, Satisfaction, and Hunger During Behavioral Weight Loss Treatment.
Brief Summary: The purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a 12-week behavioral weight loss intervention.


Options:
A: Energy density of the diet (Weeks 0 and 13)
B: Overweight and obesity according to IOTF references (0-1-2 years)
C: Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation); Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation)
D: Number of Targeted Products Selected Relative to Others (up to 8 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Diets Targeting Energy Density and Energy Restriction on Weight Loss and Feelings of Deprivation, Satisfaction, and Hunger During Behavioral Weight Loss Treatment.
Brief Summary: The purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a 12-week behavioral weight loss intervention.


Options:
A: Energy density of the diet (Weeks 0 and 13)
B: Change of Child Body Composition (Baseline to 6 months); Change Parent Body Composition (Baseline to 6 months)
C: Number of Targeted Products Selected Relative to Others (up to 8 months)
D: Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation); Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary ByPass Surgery; A Randomized Controlled Trial
Brief Summary: Experimental data have demonstrated favourable effects of statins on endothelial progenitor cell (EPC) mobilization from the bone marrow, and cardiac homing. The purpose of the present prospective randomized controlled trial is to determine the effects of aggressive atorvastatin treatment (40 mg daily 2-weeks prior to surgery) on the number of endothelial progenitor cells (EPCs) after cardiopulmonary bypass by comparing with placebo.


Options:
A: Endothelial Progenitor Cells (EPCs) Count (Cells/µl) (Postoperative 6th hours)
B: Postoperative blood loss (Postoperatively)
C: plasma troponin T level (within the first 7 days after surgery)
D: Difference in occurrence of postoperative cognitive dysfunction between control and intervention group at six days after surgery as determined by using a validated battery of cognitive tests (9 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary ByPass Surgery; A Randomized Controlled Trial
Brief Summary: Experimental data have demonstrated favourable effects of statins on endothelial progenitor cell (EPC) mobilization from the bone marrow, and cardiac homing. The purpose of the present prospective randomized controlled trial is to determine the effects of aggressive atorvastatin treatment (40 mg daily 2-weeks prior to surgery) on the number of endothelial progenitor cells (EPCs) after cardiopulmonary bypass by comparing with placebo.


Options:
A: plasma troponin T level (within the first 7 days after surgery)
B: Endothelial Progenitor Cells (EPCs) Count (Cells/µl) (Postoperative 6th hours)
C: The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).
D: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Long Term Physical Training Once a Week on Fitness and Quality of Life in Elderly Asthmatics
Brief Summary: This controlled study is undertaken to investigate the effects of a long term outpatient training program on physical fitness and quality of life in elderly asthmatics.


Options:
A: Clinical Control (Before and after 3 months of intervention)
B: Maximum oxygen uptake (One year)
C: Asthma control Questionnaire (Juniper) (Within 1 week of completion of the intervention (i.e., after 12 weeks))
D: Asthma Control Questionnaire (Baseline, 6- and 12-months)

Answer: B