TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week, Randomized, Double-Blind, Double-Dummy, Placebo and Active-controlled Study of Symbicort pMDI Administered Once Daily in Adults and Adolescents With Asthma - STEM
Brief Summary: The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults


Options:
A: Change From Baseline to Week 12 in 1h Post-dose FEV1 (Week 0 (baseline), Week 12)
B: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
C: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
D: Change in evening PEF (Daily throughout the 12 week treatment period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week, Randomized, Double-Blind, Double-Dummy, Placebo and Active-controlled Study of Symbicort pMDI Administered Once Daily in Adults and Adolescents With Asthma - STEM
Brief Summary: The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults


Options:
A: Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year) (evaluated monthly (on average) via questionnaire for 12 months)
B: Change in evening PEF (Daily throughout the 12 week treatment period)
C: Number of Participants With 1 or More Severe Asthma Exacerbations (Baseline to Follow-up (up to 76 weeks of treatment))
D: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Journey for Control of Diabetes Study
Brief Summary: Behavior change and self-efficacy are key for patients with diabetes to sustain blood sugar goals, but most care systems do not provide effective support to assist patients in successful ongoing self-management. After initial education, many programs are limited by allowable Medicare reimbursement for diabetes education which currently requires physician referral and cannot exceed two hours of training per year for a beneficiary, plus one hour of nutritional services. These services are usually provided either on an individual basis or occasionally through a traditional group class approach. For patients with established type 2 diabetes who are not achieving optimal glycemic control, we propose to develop and formally evaluate in a randomized trial a novel group experience to educate and motivate patients with established type 2 called IDEA, (Interactive Dialogue to Educate and Activate). This multi-site, randomized, prospective trial will randomize 621 patients with inadequately blood sugar control levels to one of 3 study groups: (1) IDEA - patients receive group sessions totaling 8 hours, with an average of 10 patients per group, using conversation maps as a conduit to facilitate dialogue between providers and patients (2) Individual Education (IE) - patients receive 2 hours with a nurse educator and 1 hour with a dietitian, and (3) Usual care (UC)- patients receive no research intervention. The primary analyses will involve mixed model regression to assess whether IDEA improves outcomes compared to IE and UC. Blood sugar level, blood pressure, and lipids will be evaluated 6 and12 months post-randomization and behavioral, emotional, and satisfaction outcomes through survey at baseline, 3, 6, 9 and 12 months. Depending on 12 month results, a longitudinal four year post intervention analysis is planned to assess sustainability of treatment effects and cost-effectiveness.


Options:
A: Program satisfaction, behavioral and emotional outcomes. (3, 6, 9, 12 months after implementation of intervention)
B: Change in Glycemic Control (HbA1c) (6 months (baseline to 6 months))
C: Change in HbA1c at 12 months (12 months)
D: Hemoglobin A1c (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine (580299) Co-administrated With a Commercially Available Vaccine in Healthy Female Adolescents
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.


Options:
A: Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms (Within 7 days after each vaccine dose)
B: Cervical infection with HPV-16 and/or HPV-18 (Throughout the study)
C: Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection (Month 7); Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion (Month 7); Anti-HPV-16/18 Antibody Titres (Month 7)
D: Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At 18, 24, 36 and 48 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-inferiority of Co-administration of GSK Biologicals'Pneumococcal Conjugate Vaccine GSK1024850A With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib.
Brief Summary: The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Nasopharyngeal bacterial (pneumococcal) colonization at 6 weeks, 6, 12, 18 and 24 months in infants and at 12 and 24 months of family members (duration of study, 23 months per subject); transmission to family members( sib, caregiver) (at infants age of 12 and 24 months)
B: Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).); Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).)
C: Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) (Any time from 2 weeks after Dose 3 up to 31 August 2010)
D: Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination (At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine); Antibody Concentration Against Protein D (PD) - Primary Vaccination (At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-inferiority of Co-administration of GSK Biologicals'Pneumococcal Conjugate Vaccine GSK1024850A With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib.
Brief Summary: The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) (Any time from 2 weeks after Dose 3 up to 31 August 2010)
B: Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)); Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months))
C: Nasopharyngeal bacterial (pneumococcal) colonization at 6 weeks, 6, 12, 18 and 24 months in infants and at 12 and 24 months of family members (duration of study, 23 months per subject); transmission to family members( sib, caregiver) (at infants age of 12 and 24 months)
D: Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination (At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine); Antibody Concentration Against Protein D (PD) - Primary Vaccination (At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Modified Ritgens Maneuver for Perineal Protection at Delivery
Brief Summary: The aim of the investigation was to assess whether routine use of the modified Ritgen´s maneuver decreases the risk of anal sphincter injury at delivery, compared with simple manual protection of the perineum.Ritgen´s maneuver means that the fetal chin is reached for between the anus and the coccyx and pulled anteriorly, while using the fingers of the other hand on the fetal occiput to control speed of delivery and keep flexion of the fetal neck.


Options:
A: Perineal rupture grade III-IV (anal sphincter tears) (At delivery - within minutes - hours of randomization)
B: Grade I and II rupture during delivery (time at the delivery department (up to 12 months))
C: Episiotomy procedures (until completed the second stage of labour, about from 30 min to 24 h)
D: Number of patients with perineal tears (perineal tears are evaluated within 1 hour of delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Modified Ritgens Maneuver for Perineal Protection at Delivery
Brief Summary: The aim of the investigation was to assess whether routine use of the modified Ritgen´s maneuver decreases the risk of anal sphincter injury at delivery, compared with simple manual protection of the perineum.Ritgen´s maneuver means that the fetal chin is reached for between the anus and the coccyx and pulled anteriorly, while using the fingers of the other hand on the fetal occiput to control speed of delivery and keep flexion of the fetal neck.


Options:
A: Incidence of Perineal laceration - any degree (at the time of delivery)
B: Number of patients with perineal tears (perineal tears are evaluated within 1 hour of delivery)
C: PERINEAL LACERATION Primary outcome: 1. Perineal laceration - present or absent (1 hour postpartum)
D: Perineal rupture grade III-IV (anal sphincter tears) (At delivery - within minutes - hours of randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
Brief Summary: The purpose of this study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome.


Options:
A: Shoulder Pain and Disability Index (SPADI) (Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months)
B: Shoulder Pain and Disability Index (1 year)
C: Constant-Murley shoulder assessment (Baseline and change after three months of exercises, 3 month follow-up); Constant_Murley shoulder assessment (Change from baseline to the 12-month follow-up)
D: Shoulder Pain and Disability Index (Baseline and 11 weeks); Participant perceived global rating of change post treatment (11 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
Brief Summary: The purpose of this study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome.


Options:
A: Oxford Shoulder Score (4 months)
B: Oxford Shoulder Score (6 months post randomisation)
C: Shoulder Pain and Disability Index (SPADI) (Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months)
D: Shoulder Pain and Disability Index (Baseline and 11 weeks); Participant perceived global rating of change post treatment (11 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin.
Brief Summary: The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (\< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.


Options:
A: Difference in A1c Levels (baseline and 24 weeks); Number of Hypoglycemic Events (between 1rst and 24 weeks of each treatment arm)
B: Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
C: Glycemic variability (24 weeks)
D: Change in HbA1c (percentage %) (Baseline to 6 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism
Brief Summary: The aim of our study is to assess the effect of daily consumption of yogurt containing probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in out of home child care.


Options:
A: Evaluate the efficacy of fermented milk and rice administered daily for a total duration of 3 months on the appearance of common respiratory and gastrointestinal infections in schoolchildren aged between 12 and 48 months. (3 months)
B: Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism (16 weeks)
C: Incidence of infectious diseases
D: average weight gain (4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism
Brief Summary: The aim of our study is to assess the effect of daily consumption of yogurt containing probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in out of home child care.


Options:
A: Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism (16 weeks)
B: Severity of cold symptoms (3 months)
C: average weight gain (4 months)
D: Natural killer cell activity (At baseline); Natural killer cell activity (At 12-week follow-up); Change from baseline natural killer cell activity at 12-week (At baseline and 12-week follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study to Assess the Safety and Immunogenicity of New TB Vaccine Candidates FP85A and MVA85A, in Healthy Adults Who Have Previously Been Immunized With BCG, Using a Prime-boost Delivery Schedule
Brief Summary: This is a Phase I study whose primary outcome is to assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG. The secondary outcome is to assess the cellular immune response in the same population. The trial consists of 36 subjects in 3 groups. The first group will be vaccinated with FP85A alone, the second group will be vaccinated with MVA85A followed by FP85A 28 days later and the third group will be vaccinated with FP85A followed by MVA85A 28 days later.


Options:
A: To assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG (3 months)
B: The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each mmunisation (and after 7 days).; Blood will be taken at: the screening visit, prior to the BCG vaccination, 1 and 4 weeks after the BCG vaccination, and also at 1,4, 8, 12 and 24 weeks after the MVA85A vaccination.
C: Safety (1 year)
D: The occurence and severity of local side-effects The occurence and severity of systemic side-effects (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Local Infiltration Analgesia (LIA) With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Unicompartmental Knee Arthroplasty
Brief Summary: The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. Secondary end-points are morphine consumption, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 6 months after surgery.


Options:
A: Self-reported pain and physical function (WOMAC)
B: The primary aim of this study was to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect hospital stay. (April, 2007)
C: pain score (4 hours)
D: Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. (1, 6, 24 & 48 hours); The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. (1, 6, 24 & 48 hours); Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively (1, 6, 24 & 48 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of BCG (Bacille Calmette-Guerin) Vaccine Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Previously Received BCG.
Brief Summary: Tuberculosis (TB) kills about three million people annually. It is estimated that one third of the world's population are latently infected with Mycobacterium tuberculosis (M.tb). Multi-drug resistant strains of M.tb, and co-infection with M.tb and HIV present major new challenges. The currently available vaccine, M. bovis BCG, is largely ineffective at protecting against adult pulmonary disease in endemic areas and it is widely agreed that a new more effective tuberculosis vaccine is a major global public health priority1. However, it may be unethical and impractical to test and deploy a vaccine strategy that does not include BCG, as BCG does confer worthwhile protection against TB meningitis and leprosy. An immunisation strategy that includes BCG is also attractive because the populations in which this vaccine candidate will need to be tested will already have been immunised with BCG.

M.tb is an intracellular organism. CD4+ Th1-type cellular responses are essential for protection and there is increasing evidence from animal and human studies that CD8+ T cells also play a protective role2. However, it has generally been difficult to induce strong cellular immune responses in humans using subunit vaccines. DNA vaccines induce both CD4+ and CD8+ T cells and thus offer a potential new approach to a TB vaccine. DNA vaccines encoding various antigens from M. tuberculosis have been evaluated in the murine model, and to date no DNA vaccine alone has been shown to be superior to BCG.

A heterologous prime-boost immunisation strategy involves giving two different vaccines, each encoding the same antigen, several weeks apart. Such regimes are extremely effective at inducing a cellular immune response. Using a DNA- prime/MVA-boost immunisation strategy induces high levels of CD8+ T cells in animal models of malaria and HIV5, and high levels of both CD4+ and CD8+ T cells in animal models of TB. BCG immunisation alone induces only CD4+ T cells in mice. A prime-boost strategy using BCG as the prime and a recombinant MVA encoding an antigen from M.tb that is also present in BCG (antigen 85A: 'MVA85A') as the boost, induces much higher levels of CD4+ T cells than BCG or MVA85A alone. In addition, this regime generates specific CD8+ T cells that are undetectable following immunisation with BCG alone.


Options:
A: The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each immunisation (and after 7 days).
B: The occurence and severity of local side-effects The occurence and severity of systemic side-effects (1 year)
C: Safety (1 year)
D: Safety of MVA85A (Six months)

Answer: B