TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.


Options:
A: Time to an Exacerbation (Baseline to end of study (up to 59 days))
B: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)
C: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
D: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.


Options:
A: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
B: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))
C: Number of Participants With Treatment-Emergent Adverse Events (56 days)
D: Time to an Exacerbation (Baseline to end of study (up to 59 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Brief Summary: This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.


Options:
A: Recurrence of intimate partner violence (18 months); Health-specific quality of life (18 months); Harms of screening and/or usual care (18 months)
B: prevalence of non-users of street opioid after one year of treatment will be compared between arms. (one year)
C: Post-Release Opioid Relapse (Four weeks post-release)
D: Primary Outcome Measure (5 years); Primary Outcome Measure (5 years); Primary Outcome Measure (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Brief Summary: This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.


Options:
A: Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS. (Changes from baseline until endpoint at week 5)
B: Post-Release Opioid Relapse (Four weeks post-release)
C: Abstinence (3 month follow up); Abstinence (6 month follow up); Abstinence (9 month follow up); Abstinence (12 month follow up); Abstinence (18 month follow up); Abstinence (24 month follow up); Cocaine Urine Toxicology (3 month follow up); Cocaine Urine Toxicology (6 month follow up); Cocaine Urine Toxicology (9 month follow up); Cocaine Urine Toxicology (12 month follow up); Cocaine Urine Toxicology (18 month follow up); Cocaine Urine Toxicology (24 month follow up); Comparison Across Groups in Societal Costs (24 months); Net Saving/Spending Comparisons Across Groups From Provider Perspective (24 months); Net Comparisons of Savings and Spendings Across Groups From Societal Perspective (24 months); Percent Days Cocaine Use (3 months (approximately study days 1 - 90)); Percent Days Cocaine Use (6 months (approproximately study days 91 - 180)); Percent Days Cocaine Use (9 months (approximately study days 181 - 270)); Percent Days Cocaine Use (12 months (approximately study days 271 - 365)); Percent Days Cocaine Use (18 months (approximately study days 366 - 546)); Percent Days Cocaine Use (24 months (approximately study days 547 - 730)); Percent Days Abstinent (3 months (approximately study days 1 - 90)); Percent Days Abstinent (6 months (approximately study days 91 - 180)); Percent Days Abstinent (9 months (approximately study days 181 - 270)); Percent Days Abstinent (12 months (approximately study days 271 - 365)); Percent Days Abstinent (18 months (approximately days 366 - 546)); Percent Days Abstinent (24 months (approximately study days 547 - 730))
D: Time to post release treatment engagement (30 days post release); Reduction of HIV risk behaviors (12 months); Time to relapse (30 days post release); Cost effectiveness (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Short Bursts of Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke
Brief Summary: The purpose of this study is to compare two different walking training programs for persons with chronic stroke.


Options:
A: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)
B: walking speed (meters/second); walking distance (distance walked in 6-minutes)
C: Improvement ín motor function among patients in each group
D: Gait speed: measured with the comfortable 10-meter walk test (The outcome measure will be assessed at pre-test (within 1-week before beginning the intervention), post-test (within 1-week after completing the 2-week intervention period) and at retention (3-months following completion of the intervention).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy
Brief Summary: Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood.

Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.


Options:
A: Change of Visual Development of newborn (Change from Baseline at 12 months of life)
B: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
C: percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood (labour)
D: Persistent wheeze 0 to 3 years of age (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy
Brief Summary: Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood.

Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.


Options:
A: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
B: 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)
C: Percentage of Total Fatty Acids by Weight (at time of birth); Gestational Age (at time of birth); Birth Weight (at time of birth); Birth Length (at time of birth)
D: percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood (labour)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A-LONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A
Brief Summary: The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.


Options:
A: Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units) (52 weeks after treatment start for patients on prophylaxis); Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units) (28 weeks after treatment start on on-demand treatment)
B: Incidence Rate of FVIII Inhibitor Development (up to 52 weeks ± 2 weeks); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values From Baseline (up to 52 weeks ± 2 weeks); Number of Participants With Clinically Relevant Abnormalities in Vital Signs or Relevant Changes From Baseline in Vital Signs (up to 52 weeks ± 2 weeks); Annualized Bleeding Rate (up to 52 weeks ± 2 weeks (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates: Arm 1 Versus Arm 3 (up to 52 weeks ± 2 weeks (efficacy period as defined in description)); Area Under the Curve (AUC) Per Dose (One-stage Clotting Assay) (See Measure Description for complete time frame.); Elimination Half Life (t1/2; One-stage Clotting Assay) (See Measure Description for complete time frame.); Clearance (CL; One-stage Clotting Assay) (See Measure Description for complete time frame.); Mean Residence Time (MRT; One-stage Clotting Assay) (See Measure Description for complete time frame.); Incremental Recovery (One-stage Clotting Assay) (See Measure Description for complete time frame.)
C: Evaluate the efficacy, safety and pharmacoeconomic of long-term secondary prophylaxis with Kogenate Bayer in comparison to on-demand treatment with Kogenate Bayer in terms of joint bleeding episodes per year (Every 6 months)
D: Annualized Number of Bleeding Episodes (Baseline up to Week 56)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Behandling av Keratoconus Med "Cornea Collagen Cross-linking" Uten Hornhinneepitelfjerning
Brief Summary: Transepithelial CXL (performed without epithelial removal) seem to have similar clinical effect on keratoconic eyes compared to the standard CXL (which includes epithelial removal). The current study attempts to prove that hypothesis.

A prospective, controlled, randomized, contralateral trial, will involve one eye of the patient to be treated with transepithelial CXL, while the control eye will be treated with the standard CXL. Totally 20 patients (age \>18 and \<40 years) referred by an ophthalmologist to the eye department of the University Hospital North Norway for CXL treatment of bilateral progressive keratoconus, will be recruited.


Options:
A: Visual acuity (1 year); Keratometry measurements (1 year)
B: evaluation of depth of demarcation line (1 month postoperative)
C: Best corrected distant visual acuity (BCDVA) (One year)
D: Change in Maximum Keratometry From Baseline to 6 Months After Treatment (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Centre, Randomised, Double Blind, Phase 1 Study of the Safety, Tolerability, and Immunogenicity of an Influenza Vaccine Candidate (FLU-v)
Brief Summary: The purpose of this study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects. The study is also designed to evaluate four different dose formulations of the vaccine to see which gives the best immune response.


Options:
A: 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))
B: The number of laboratory-confirmed influenza cases in infants born to mothers who received TIV or placebo will be used to determine efficacy of TIV vaccination of pregnant women against laboratory-confirmed influenza illness in their infants (24 weeks of age); Humoral and cell-mediated immune (CMI) responses to influenza strains in the vaccine will be measured to assess the immunogenicity of TIV in pregnant women vaccinated between 20-34 weeks of gestational age (one month post vaccination, delivery (+7 days), 24 weeks post natal)
C: Safety and tolerability of FLU-v (Measurements will be taken at screening, then up to 21 days post-vaccination)
D: Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine. (Day 21)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema
Brief Summary: The purpose of this study is to assess the procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.


Options:
A: Quality of Life Assessment. (Three + Months Follow-Up Visit)
B: Reduction in gas trapping (12 weeks post treatment); SAEs - Safety of treatment and the procedure (2 years)
C: Change in Percent Volume of Lung (12 weeks following treatment)
D: increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
Brief Summary: The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.


Options:
A: Pregnancy (AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year)
B: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))
C: N/A
D: 12 month cumulative COC discontinuation probabilities (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
Brief Summary: The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.


Options:
A: LNG Steady State at Baseline and Then Post-randomization (baseline (2 months) and post-randomization (4 months))
B: Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, (13 cycles, 28 days each (1 year)); Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population (13 Cycles, 28 days each (1 year))
C: Pregnancy (AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year)
D: Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression. (Up to 8 biweekly visits from start of OCP therapy)

Answer: C
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: Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC). (6 months post-pullthrough); Severity of Clinical Episodes of HAEC (6 months)
B: Composition of the Fecal Microbiota (Final stool sample at 6 weeks)
C: Time to reach full feeds (First 40 days after birth)
D: NEC onset (6 weeks)

Answer: C
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: NEC onset (6 weeks)
B: Time to reach full feeds (First 40 days after birth)
C: Necrotizing enterocolitis (8 weeks)
D: Sepsis (8 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: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
B: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
C: Time to reach full feeds (First 40 days after birth)
D: NEC onset (6 weeks)

Answer: C