TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study
Brief Summary: Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.

One of the treatment options available is to repair the anterior wall surgically. The goals of surgery are to return the anatomy to its usual position, ensuring that all the pelvic floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair would also be long lasting.

Two surgical options are routinely performed in Calgary for repair of an anterior compartment prolapse. One option involves fixing the organs back in place using sutures. The other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The investigators do not know which of these two options is the best surgical procedure. Both may have different advantages that would result in better results. This study is designed to try and find out if one of these procedures is better, and if a larger study may be needed.


Options:
A: Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (one year)
B: Number of Participants With Anatomic Cure at 3 Years (3 year)
C: Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative) (12 months postoperatively)
D: To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Brief Summary: Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns. The condition involves abnormal development of lung tissue and is characterized by inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce the incidence of BPD and another commonly associated condition called pulmonary hypertension, which is high blood pressure in the vessels carrying blood to the lungs.. This study will determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary hypertension, and death in premature newborns.


Options:
A: Survival without chronic lung disease (CLD) (36 weeks)
B: Participant's survival without CLD ((measured at 36 weeks after birth))
C: Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality (Week 36 or earlier, if participants are discharged from the hospital); Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight (Randomization to discharge)
D: Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress (21 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Adult Patients Suffering From Grass Pollen Rhinoconjunctivitis
Brief Summary: The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.


Options:
A: Recording of allergy symptoms (Grass pollen season 2007)
B: Pharmacodynamics - Immunological assessments (Pre- and post treatment)
C: determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo (September 2009)
D: Combined Score (CS) (Pollen period (average of 42.8 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Adult Patients Suffering From Grass Pollen Rhinoconjunctivitis
Brief Summary: The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.


Options:
A: determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo (September 2009)
B: Combined Score (CS) (Pollen period (average of 42.8 days))
C: change in symptom score active versus placebo
D: Percentage of Participants Who Experienced At Least One Adverse Event (AE) (From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (From first dose to last dose of treatment, up to 28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion and Whole-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children
Brief Summary: A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.


Options:
A: Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children . (July 2009- Sept. 2009)
B: Incidence ratio for acute MI (28 days)
C: 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.)
D: cardiovascular death (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
Brief Summary: This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.


Options:
A: Immunogenicity After Dose 3 (1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months))
B: Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45 (18 months from enrollment)
C: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)
D: Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
Brief Summary: This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.


Options:
A: Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) (Throughout the study period (up to Month 24))
B: Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45 (18 months from enrollment)
C: Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen. (From Month 0 up to Month 12)
D: The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay. (4 weeks post dose 3 injection)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Parallel Group Comparison on the Influence of a Low Carbohydrate and a Low Fat Hypocaloric 6 Months Diet on Body Weight Reduction, Metabolic and Cardiovascular Variables in Obese Healthy Women and Men.
Brief Summary: The investigators will test the hypothesis that a LOW CARB hypocaloric diet will reduce body weight over six months more than a LOW FAT hypocaloric diet. In addition to body weight, the investigators will measure cardiovascular and metabolic variables and will take blood samples in order to determine whether certain metabolites may predict the diet success.


Options:
A: Body weight reduction (Month 6)
B: weight loss
C: body weight (prior to and after 4, 8, and 12 months of dieting)
D: Change in Hemoglobin A1C (A1C) (Baseline, 12 weeks and 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Parallel Group Comparison on the Influence of a Low Carbohydrate and a Low Fat Hypocaloric 6 Months Diet on Body Weight Reduction, Metabolic and Cardiovascular Variables in Obese Healthy Women and Men.
Brief Summary: The investigators will test the hypothesis that a LOW CARB hypocaloric diet will reduce body weight over six months more than a LOW FAT hypocaloric diet. In addition to body weight, the investigators will measure cardiovascular and metabolic variables and will take blood samples in order to determine whether certain metabolites may predict the diet success.


Options:
A: Hemoglobin A1c (22 weeks)
B: N/A
C: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
D: Body weight reduction (Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Parallel Group Comparison on the Influence of a Low Carbohydrate and a Low Fat Hypocaloric 6 Months Diet on Body Weight Reduction, Metabolic and Cardiovascular Variables in Obese Healthy Women and Men.
Brief Summary: The investigators will test the hypothesis that a LOW CARB hypocaloric diet will reduce body weight over six months more than a LOW FAT hypocaloric diet. In addition to body weight, the investigators will measure cardiovascular and metabolic variables and will take blood samples in order to determine whether certain metabolites may predict the diet success.


Options:
A: Laboratory findings and body composition (2 years)
B: body weight (12 months)
C: Change in body weight (measured at Year 2)
D: Body weight reduction (Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Investigator Initiated Multicenter Prospective Randomized Study of Chemoembolization Versus Radioembolization for the Treatment of Hepatocellular Carcinoma (PREMIERE Trial)
Brief Summary: RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Radioembolization kills tumor cells by blocking the blood flow to the tumor and keeping radioactive substances near the tumor. It is not yet known which treatment regimen is more effective in treating patients with liver cancer.

PURPOSE: This randomized phase II trial is studying radioembolization to see how well it works compared with chemoembolization in treating patients with liver cancer that cannot be treated with Radiofrequency Ablation or removed by surgery.


Options:
A: Overall Survival (2 years)
B: N/A
C: Time to Progression (TTP) in Patients Treated With TACE and Y90 (Up to 6 yrs)
D: Median overall survival time (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management
Brief Summary: Although weight loss programs are effective in the short-term, maintaining weight loss is more challenging. Regularly tracking and logging physical activity (PA) and diet is related to greater improvements in PA and diet and to greater weight loss over time. Receiving continuous real-time feedback regarding calories burned and calories consumed could enhance weight loss maintenance. This study will examine whether a device that provides such feedback, called the SenseWear armband, enhances weight maintenance.

200 overweight adults aged 18 to 65 years will be randomly assigned to one of four groups: (1) a standard behavior change weight loss group-based program (14 group sessions over a 4 month period followed by 6 phone calls over a 5 month period), (2) a standard behavior change weight loss group-based program (15 group session over a 4 month period followed by 6 phone calls over a 5 month period) combined with the armband, (3) the armband alone (training in the use of the armband and a follow up telephone call), or (4) a self-directed weight loss control group.

Participants will be recruited through USC through listserv emails, flyers, and worksite advertisements. Interested individuals will take part in a telephone screen, an orientation, a run-in visit (which includes 2 weeks of PA and dietary logging), a baseline assessment, and a randomization visit. The intervention will then take place over a 9-month period with eligible participants. Participants will take part in follow-up assessments at month 4 and 9. Assessments at all three times will include questionnaires assessing diet, PA, psychosocial factors related to diet and PA, and quality of life related measures. They will also have their fasting blood drawn to assess lipids, glucose, and insulin, and staff will measure their blood pressure, waist circumference (size), skinfold, height, and weight.


Options:
A: HbA1c level (Final (before 2 years follow-up))
B: For adults: body weight loss maintenance (6 Month)
C: Change in the number of incontinent episodes (6 months)
D: Waist Circumference (Month 9); Body Weight (nine month); Body Weight (4 month); Waist Circumference (4 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase II Multicenter Trial Evaluating the Efficacy and Safety of a Systemic Hedgehog Pathway Antagonist (GDC-0449) in Patients With Basal Cell Nevus Syndrome (BCNS)
Brief Summary: The purpose of this study is to reduce the number of new surgically eligible BCCs by 50% appearing during month 3-18 of medication ingestion.


Options:
A: Absence of local recurrence at 3 years after start of treatment
B: defect size after surgery (immediately after surgery)
C: Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (for Metastatic Basal Cell Carcinoma (mBCC)) Per Primary Efficacy Analysis Set (pEAS) (6 months); Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS) (6 months)
D: Number of New Surgically Eligible Basal-cell Carcinomas (3 months of receiving study drug)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega-3 Supplementation Decreases Inflammation and Fetal Obesity in Pregnancy
Brief Summary: Randomized, double-blind placebo controlled trial of fish oil to decrease inflammation in pregnancy.


Options:
A: Birth size (Birth); Gestational age (Birth); Changes in visual evoked potentials (3 and 6 months of age); Changes in infant weight (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes in infant height (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes In infant head circumference (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes in auditory evoked potentials (1 and 3 months of age); Changes in child development score (1, 1.5 and 5 years of age); Changes in Hearts and Flowers Stroop Test (5 years of age)
B: Heart Rate (24, 32 and 36 weeks gestational age)
C: Decreased inflammation during human pregnancy (enrollment (8-16 weeks) to delivery)
D: Insulin sensitivity (Measured at approximately Month 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Parallel Group, Placebo Controlled Safety, Tolerability and Efficacy Study of NP002 in Subjects With Idiopathic Parkinson's Disease With Dyskinesias Due to Levodopa Therapy
Brief Summary: The study is designed to answer the question: will nicotine at doses that do not cause serious side effects, show feasibility in treatment of levodopa-induced dyskinesia in patients with Parkinson's disease?


Options:
A: frequency and severity of adverse events, active vs placebo (Every two weeks during dosing (week 0 to week 12) and weekly thereafter for 2 weeks following cessation of dosing); measure of impulse control (rMIDI), active vs placebo (at screening and 4 weeks, 10 weeks, 12 weeks and 14 weeks)
B: Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score (Baseline to Week 12)
C: Balance (3 time points)
D: Percentage of "Off" Time During Waking Hours at End of Study (22 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older
Brief Summary: The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults


Options:
A: Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens (21 days to 180 days after the date of vaccination); The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values (21 Days after vaccination)
B: Humoral immune responses to influenza strains in the vaccine will be measured to assess the immunogenicity of TIV in HIV-infected pregnant women vaccinated between 20-34 weeks of gestational age (1 month post vaccination, delivery (+7 days), 24 weeks post delivery); The proportion of newborns born to HIV-infected mothers with hemagglutination inhibition (HAI) antibody titers of ≥1:40 to TIV strain will be determined and compared to newborns born to TIV-vaccinated HIV-uninfected women (parallel trial) (Delivery (+7 days))
C: Seroconversion Rate 21 Days After the First Vaccination (21 days after the first vaccination); Seroconversion Rate 21 Days After the Second Vaccination (21 days after the second vaccination); Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination (21 days after the first vaccination); Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination (21 days after the second vaccination)
D: Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains (6 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled, Single-center Study of the Efficacy and Safety of BIO-K+ CL-1285® in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.


Options:
A: Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function (immediately after heart surgery in patients with LVSD)
B: Incidence of Participants With Diarrhea by Parental Report (14 days)
C: Total Number of Antibiotic-associated Diarrhea Episodes (29 months)
D: To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. (Up to 40 days)

Answer: D