TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
Brief Summary: This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.

The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.


Options:
A: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
B: Time to reach full feeds (First 40 days after birth)
C: Feeding tolerance (Change from Full Enteral Feeding (FEF) Day 1 (start of FEF defined as achieving 150ml/day/kg of enteral feeding and discontinuation of parenteral feeding) and FEF Day 21 (approximately 5 weeks after enrollment))
D: NEC onset (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
Brief Summary: This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.

The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.


Options:
A: incidence of feeding intolerance (28 days); time to reach full enteral feedings sustained for 72 hours. (72 hours)
B: Time to reach full feeds (First 40 days after birth)
C: Number of days alive and receiving full enteral feeding (birth to 28 days)
D: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of Candidate Tuberculosis (TB) Vaccine MVA85A Administered by the Intramuscular Route and the Intradermal Route: a Phase I Randomised Active Controlled Trial
Brief Summary: This is a phase I study that will compare the safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route in healthy adult individuals who have been previously vaccinated with Bacillus Calmette-Guerin (BCG).


Options:
A: Safety (6 months following vaccination)
B: Culture and RT-PCR quantification of BCG in challenge site biopsy (10 weeks post biopsy)
C: To assess the safety of a single intradermal injection of 5 x 107p.f.u. MVA85A. (One year)
D: Safety of MVA85A. Both local and systemic adverse events will be monitored, including a daily diary card for the first week. Blood will be taken at day 7 and day 28 for biochemistry and haematology. (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistent Asthma in Adults and Adolescents Uncontrolled on Inhaled Corticosteroids
Brief Summary: The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.


Options:
A: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)
B: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
C: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
D: Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values. (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistent Asthma in Adults and Adolescents Uncontrolled on Inhaled Corticosteroids
Brief Summary: The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.


Options:
A: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
B: Change from start of treatment in evening pre-dose FEV1 (2, 6 and 12 weeks after starting treatment)
C: FEV1 peak0-3 Change From Baseline (Baseline and 12 weeks)
D: Pre-dose FEV1 (Forced Expiratory Volume in the first second) (at Week 26); Reduction of moderate and severe asthma exacerbations rate (Week 0 to Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistent Asthma in Adults and Adolescents Uncontrolled on Inhaled Corticosteroids
Brief Summary: The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.


Options:
A: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
B: For FS MDPI Versus Fp MDPI: Change From Baseline in 1-Hour Postdose Percent Predicted Morning Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Baseline, Week 12); For Fp MDPI Versus Placebo: Change From Baseline in Weekly Average of the Percent Predicted Trough Morning FEV1 at Week 12 (Baseline, Week 12)
C: Total Number of Asthma Exacerbations Reported During the Treatment Period (From Baseline (Week 1) until the end of treatment (up to Week 16))
D: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 26 weeks); Number of Participants Experiencing at Least One Asthma Exacerbation (From Day 1 up to 26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Trial to Compare Immediate and 24-hours Delayed Catheter Removal Following Total Abdominal Hysterectomy
Brief Summary: Total abdominal hysterectomy is a common gynaecological operation performed worldwide. In Hong Kong, it was the most common gynaecological open procedure done and the number of hysterectomies performed increased by almost 50% in 2004 when compared to 1999. In-dwelling catheter use after uncomplicated abdominal hysterectomy has been the standard method for bladder treatment after the operation. It is traditionally advocated to assess urinary output and to prevent post-operative urinary retention as patients with abdominal wound are unable to increase the intra-abdominal pressure to aid voiding. However, in-dwelling catheters have been associated with increased white cell counts and higher rates of positive urine cultures, and subsequently urinary tract infection can lead to increased morbidity, duration of hospital stay, and overall healthcare cost.

Duration of catheter use post-operatively is generally based on custom rather than evidence-based knowledge and therefore varies considerably. The current practice of the investigators hospital is to leave an in-dwelling catheter in-situ for 24 hours after an uncomplicated open gynaecological surgery. Schiotz et al showed that twenty-four-hour catheterization after common gynaecological procedures was associated with a low rate of voiding problems after catheter removal. Post-operative urinary retention leading to bladder atony may increase the long-term morbidity through increased risk of infection, detrusor instability and voiding difficulties. In-dwelling catheter in the immediate post-operative period will help to combat this problem. However, this has to be balanced against the potential risk of catheter-associated urinary tract infection which varies from 5% to 43% in the published trials.

A prospective randomized study comparing immediate versus delayed catheter removal following hysterectomy showed that delayed removal after operation was not associated with an increased rate of febrile events or urinary tract infections, but a significantly higher subjective pain assessment. The size of the catheter used was 16F which was not the standard 12F that the investigators used in the investigators hospital setting. It is postulated that if a smaller caliber in-dwelling catheter is used, it will not result in an increased subjective pain assessment, and the catheter can be left in-situ for 24 hours without causing increased adverse outcomes but possibly reducing recatheterisation rate post-operatively.


Options:
A: the subjective pain assessment provided by the patient post-operatively (post operatively day 1)
B: Post-operative urinary retention requiring re-catheterisation (14 days following urethral catheter removal)
C: Post-operative urinary retention requiring re-catheterisation (1 day following urethral catheter removal)
D: Number of Participants With Acute Urinary Retention (Postoperative day 1 or postpoperative 3 depending on group randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Pre-Pregnancy Supplements
Brief Summary: The purpose of this study is to determine whether daily oral supplements of multivitamins (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant women results in lower prevalence of anemia in preparation for pregnancy when compared to daily iron and folic acid supplements or folic acid alone.


Options:
A: Recurrence of cleft lip and palate (3 months)
B: Birth Size (At birth); Gestational Age (At birth); Child growth (From birth through 24 months); Child development (Up to 7 years post enrollment); Weight-for-age Z score (WAZ) (Up to 7 years post enrollment); Height-for-age Z score (HAZ) (Up to 7 years post enrollment); Weight -for-Height Z (WHZ) or Body Mass Index Z score (BMIZ) (Up to 7 years post enrollment); Body composition (Lean mass/fat free mass index) (Up to 7 years post enrollment)
C: Anemia (6 months following the start of the intervention)
D: Recurrent colorectal adenoma (May 1996-March 2004)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Pre-Pregnancy Supplements
Brief Summary: The purpose of this study is to determine whether daily oral supplements of multivitamins (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant women results in lower prevalence of anemia in preparation for pregnancy when compared to daily iron and folic acid supplements or folic acid alone.


Options:
A: Duration of diarrhea (within the first 72 hours during hospitalization)
B: gastrointestinal symptoms (14 days)
C: Time to recovery of hemoglobin after blood donation (Up to 24 weeks after blood donation)
D: Anemia (6 months following the start of the intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine
Brief Summary: The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.


Options:
A: Overall Survival (OS) (From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years))
B: Overall Survival (OS) (Randomization to Date of Death from Any Cause Up to 39.36 Months)
C: Overall Survival (Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death))
D: Loco-regional disease control as assessed by evidence of tumor at 3 years (Time from randomization to first local recurrence up to 3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine
Brief Summary: The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.


Options:
A: Incidence of Adverse events; Changes in Lab values; Incidence of HAHA formation
B: Overall Survival (OS) (From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years))
C: Overall Survival (OS) (Randomization to Date of Death from Any Cause Up to 39.36 Months)
D: Progression free survival (every course for first three courses, then every other course)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
Brief Summary: The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.

Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C):

H0: δ ≤ -δ0 versus H1: δ \> -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin


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: Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 (At Month 7); Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) (At Month 7)
C: Time to the First New Persistent Infection of HPV 6, 11, 16, or 18 (From baseline to participant's last study visit, for up to 4 years)
D: Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. (Up to Month 48); Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). (Up to Month 48); Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. (Up to Month 84); Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). (Up to Month 84)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
Brief Summary: The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.

Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C):

H0: δ ≤ -δ0 versus H1: δ \> -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin


Options:
A: Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer (Follow-up through end of study (4 years)); Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] (Follow-up through end of study (4 years))
B: 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))
C: Number of Subjects With Injection Site Adverse Experiences (Days 1-5 following any vaccination visit)
D: Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms (Within 7 days after each vaccine dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections in Long-Acting Reversible Contraceptive Users
Brief Summary: This study randomizes women using long-acting reversible methods of contraception to home-based STD screening through the mail compared to screening available in a clinical setting. We hypothesize that women randomized to home-based screening will be more likely to complete screening.


Options:
A: Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group (At the time of Visit 5 (i.e. at 18.5 years of age))
B: Number of tests received
C: Yield ratio tested for uro-genital C.trachomatis infection; Yield ratio diagnosed for uro-genital C.trachomatis infection; Yield ratio treated for uro-genital C.trachomatis infection
D: Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections in Long-Acting Reversible Contraceptive Users
Brief Summary: This study randomizes women using long-acting reversible methods of contraception to home-based STD screening through the mail compared to screening available in a clinical setting. We hypothesize that women randomized to home-based screening will be more likely to complete screening.


Options:
A: Number of tests received
B: chlamydia and gonorrhea tests completed; chlamydia and gonorrhea infections detected
C: Yield ratio tested for uro-genital C.trachomatis infection; Yield ratio diagnosed for uro-genital C.trachomatis infection; Yield ratio treated for uro-genital C.trachomatis infection
D: Percent of women rescreened for chlamydia

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Efficacy of Erythropoietin Produced in the Institute of Technology in Immunobiology of the Oswald Cruz Foundation (BioMaguinhos/FioCruz/MS) and Erythropoietin Industrialized in Patients With Chronic Renal Failure
Brief Summary: A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis


Options:
A: Hemoglobin Level in blood (Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months)
B: Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First (Baseline up to approximately 8.5 years)
C: Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 (Up to Week 24)
D: Change in hemoglobin (Hb) from baseline to the end of the study; Primarily interested in the change in Hb between Q2W vs Q4W groups. Protocol Addendum: Hb change from baseline to end of open-label extension (no more than 36 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation
Brief Summary: The objectives of this study are to test if hypoxia in muscle tissue is an important factor contributing to clinical symptoms in chronic rheumatic muscle inflammation and to evaluate if a 12 week endurance exercise program will improve muscle tissue hypoxia and disability in patients with chronic rheumatic muscle inflammation.


Options:
A: Canadian Occupational Performance Measure (COPM) (3 months)
B: Efficacy based on VO2,max (10 weeks)
C: Aerobic Capacity (Twelve weeks); Muscle strength (Twelve weeks); Quality of life (Twelve weeks)
D: Hypoxia related metabolites. (At baseline before intervention.); Hypoxia related metabolites. (After 12 weeks of endurance exercise intervention/ non intervention.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Brief Summary: Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Options:
A: To demonstrate an increase in smoking abstinence rate (12 months)
B: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
C: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
D: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))

Answer: C