TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study of Epidural Steroid Injection Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis
Brief Summary: This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.


Options:
A: Medical Outcomes Study 36-item Short Form Health Survey (Measured at Month 24)
B: Mean Change in VAS (Baseline and 6 weeks prior to cross-over); Mean Change in ODI (Baseline and 6 weeks prior to cross-over); Mean Change in VAS (Baseline and 26 weeks After ESI to mild cross-over); Mean Change in ODI (Baseline and 26 weeks After ESI to mild cross-over)
C: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)
D: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease
Brief Summary: Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.

C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation. Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP have also been found in patients with COPD. In some studies, steroid inhalers have reduced CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid.

It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.


Options:
A: All cause mortality at 3 years
B: Change in serum C-reactive protein levels over 3 months between treatment groups.
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: CRP (4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease
Brief Summary: Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.

C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation. Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP have also been found in patients with COPD. In some studies, steroid inhalers have reduced CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid.

It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.


Options:
A: Rate of healthcare utilisation based exacerbations of COPD
B: Standardized Dyspnea Score at Isotime During Exercise (2 Weeks)
C: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
D: CRP (4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma
Brief Summary: Asthma is a chronic disease, which means that it cannot be cured, but the investigators can use inhalers and tablets to control the symptoms. In asthma, the airways become inflamed and irritated which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in asthma. Doctors have different ways to measure the inflammation in the airways. One way is to measure a gas called nitric oxide (NO) on the breath. This is made by the lungs when asthmatic inflammation is present. The investigators have been using NO as a test in research labs for many years, but there are still unanswered questions about how it changes between morning and night and how quickly medicines work on it. In most asthmatics, even small doses of inhaled steroids (preventers) can reduce the NO levels to normal, but in some people this does not seem to happen. The investigators now have portable NO machines that are designed for patients to use in the home. The investigators want to follow NO readings in patients with high levels to measure how they respond to different doses of steroid inhalers. The investigators hope this will help the investigators better understand asthma inflammation and treatments.


Options:
A: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
B: Change in FENO (2 weeks)
C: Time to Treatment Failure (Measured in Days) (Measured during the 36-week treatment period)
D: symptom-free days (1 year time frame with visits every 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma
Brief Summary: Asthma is a chronic disease, which means that it cannot be cured, but the investigators can use inhalers and tablets to control the symptoms. In asthma, the airways become inflamed and irritated which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in asthma. Doctors have different ways to measure the inflammation in the airways. One way is to measure a gas called nitric oxide (NO) on the breath. This is made by the lungs when asthmatic inflammation is present. The investigators have been using NO as a test in research labs for many years, but there are still unanswered questions about how it changes between morning and night and how quickly medicines work on it. In most asthmatics, even small doses of inhaled steroids (preventers) can reduce the NO levels to normal, but in some people this does not seem to happen. The investigators now have portable NO machines that are designed for patients to use in the home. The investigators want to follow NO readings in patients with high levels to measure how they respond to different doses of steroid inhalers. The investigators hope this will help the investigators better understand asthma inflammation and treatments.


Options:
A: symptom-free days (1 year time frame with visits every 3 months)
B: Time to Treatment Failure (Measured in Days) (Measured during the 36-week treatment period)
C: Change in FENO (2 weeks)
D: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet¿s Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy
Brief Summary: The purpose of this pivotal trial is to evaluate subcutaneous (SQ) AIN457 as an adjunctive therapy to reduce the rate of exacerbations of posterior uveitis or panuveitis secondary to Behçet's disease during the 24 weeks of study therapy as compared to standard of care alone.


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

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vasopressin Receptor Agonists in Septic Shock: Effects on Microcirculation
Brief Summary: The present study was conducted as a prospective, randomized study to investigate the effects of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock.


Options:
A: Standing Dose of Norepinephrine Which is Required to Maintain a Mean Arterial Pressure (MAP) of 65 mmHg - Hour 1 (1 hour after initiation of angiotensin II (ATII)); Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2 (2 hours after initiation of ATII)
B: Systemic and regional hemodynamics (during the first 48 hours from the onset of septic shock)
C: Hospital Mortality (prior to discharge or 60 days, whichever comes first)
D: Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI) (over a period of 6 hrs from the time of randomization); Oxygen transport variables (over a period of 6 from the time of randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Unilateral vs. Bilateral IBV Placement
Brief Summary: Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.


Options:
A: Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) (12 and 24 weeks following treatment)
B: Improvement in pulmonary function (FEV1) 6-minute walking test (3 months)
C: The difference between the response rates of the treatment and control groups. (3-months post randomization)
D: Lung Volume Change (30 Days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) 580299 Vaccine in Healthy Chinese Female Subjects
Brief Summary: This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group will receive the control.


Options:
A: Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age (At Month 7); Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48 (At Months 18, 24, 36 and 48)
B: To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme (6 months)
C: Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) (Before and one month after vaccination with Boostrix); Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies (Before and one month after vaccination with Boostrix); Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies (Before and one month after vaccination with Menactra)
D: Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens (One month after the third dose (at Month 7))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy
Brief Summary: This study is being conducted to determine if intravitreal injections of ranibizumab decrease the proportion of eyes in which vitrectomy is performed compared with saline injections in eyes presenting with vitreous hemorrhage from proliferative diabetic retinopathy.


Options:
A: amount of intraoperative intra-ocular bleeding (three weeks)
B: The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (3 months after last surgery)
C: N/A
D: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy
Brief Summary: This study is being conducted to determine if intravitreal injections of ranibizumab decrease the proportion of eyes in which vitrectomy is performed compared with saline injections in eyes presenting with vitreous hemorrhage from proliferative diabetic retinopathy.


Options:
A: Functional Macular Evaluation (24 weeks)
B: fluorescein angiography leakage area (from baseline to week 48.)
C: Pain recorded using a Visual Analog Scale (15 minutes after the procedure)
D: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy
Brief Summary: This study is being conducted to determine if intravitreal injections of ranibizumab decrease the proportion of eyes in which vitrectomy is performed compared with saline injections in eyes presenting with vitreous hemorrhage from proliferative diabetic retinopathy.


Options:
A: total area of fluorescein leakage from active new vessels (baseline, weeks 1,6,12,24,36,48); Best corrected Visual Acuity (BCVA) (Baseline, weeks 1,6,12,24,36,48); central macular thickness (baseline, weeks 1,6,12,24,36,48)
B: The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (3 months after last surgery)
C: Functional Macular Evaluation (24 weeks)
D: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Open Randomized Clinical & Health Economic Trial Comparing Intralesional Antimony Therapy Versus Wound Care Management in Old World Cutaneous Leishmaniasis Patients in Northern Afghanistan
Brief Summary: The rationales of a clinical trial comparing intralesional antimonial therapy versus wound care management in patients with old world cutaneous leishmaniasis (OWCL) are the following:

1. The effectiveness of the current mainstay treatment with intralesional antimonials for CL is subject to discussion, especially in L. major lesions which are predominant in Northern Afghanistan
2. The importance of wound care management in patients with OWCL has been emphasized by Gonzalez et al. (2008) and its efficacy is confirmed in the Kabul trial with L. tropica patients.

Parallel to the clinical efficacy the trial investigates the cost-effectiveness and -utility of the treatment options under study.


Options:
A: Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure (Assessment of cure is made at 2 months after treatment)
B: (1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.; (2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.
C: Wound closure time (75 days)
D: Final Clinical Cure Rate (Day 42, 98, and 168)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Open Randomized Clinical & Health Economic Trial Comparing Intralesional Antimony Therapy Versus Wound Care Management in Old World Cutaneous Leishmaniasis Patients in Northern Afghanistan
Brief Summary: The rationales of a clinical trial comparing intralesional antimonial therapy versus wound care management in patients with old world cutaneous leishmaniasis (OWCL) are the following:

1. The effectiveness of the current mainstay treatment with intralesional antimonials for CL is subject to discussion, especially in L. major lesions which are predominant in Northern Afghanistan
2. The importance of wound care management in patients with OWCL has been emphasized by Gonzalez et al. (2008) and its efficacy is confirmed in the Kabul trial with L. tropica patients.

Parallel to the clinical efficacy the trial investigates the cost-effectiveness and -utility of the treatment options under study.


Options:
A: (1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.; (2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.
B: Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure (Assessment of cure is made at 2 months after treatment)
C: Wound closure time (75 days)
D: Final Clinical Cure Rate (Day 42, 98, and 168)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Brief Summary: The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with mothers in South Africa, most of whom are at risk delivering babies with fetal alcohol syndrome, babies that are underweight, or babies that are infected with HIV from an HIV-positive mother. The investigators hypothesize that the intervention will reduce the chance of these three health outcomes occurring in the babies and improve the health of the mother.


Options:
A: Composite GHP outcomes health score (baseline); Composite GHP outcomes health score (6 months); Composite GHP outcomes health score (12 months)
B: Parenting Behavior Assessment (adapted from multiple scales for this context) (1 month); Parenting Self-Efficacy and Beliefs Assessment (adapted from other scales for this context; includes unique items developed for this context) (1 month); Child Behavior Assessment (items adapted from the Strengths and Difficulties Questionnaire) (1 month); Parent-Child Interaction Observation (1 month); Child Cognitive / Pre-Academic Abilities and Emotional Well-being (1 month)
C: CD4 count (6-monthly); RNA viral load (6-monthly); Haemoglobin (6-monthly); self-reported adherence (CASE index) (6-monthly); health-related quality of life (EQ-5D/EQ-VAS) (6-monthly); anthropometrics (monthly to 6-monthly); food security (USDA scales) (6-monthly); time allocation/physical activity levels (6-monthly); household welfare (6-monthly)
D: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Brief Summary: The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with mothers in South Africa, most of whom are at risk delivering babies with fetal alcohol syndrome, babies that are underweight, or babies that are infected with HIV from an HIV-positive mother. The investigators hypothesize that the intervention will reduce the chance of these three health outcomes occurring in the babies and improve the health of the mother.


Options:
A: Child Emergency Room Presentation Rates (Program enrollment until 24 months of Child Age.); Mother Emergency Room Presentation Rates (Program enrollment until 24 months postnatal.); Child Hospital Admissions (Program enrollment until 24 months postnatal.); Mother Hospital Admissions (Program enrollment until 24 months postnatal.)
B: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
C: Postpartum Clinic Attendance (assessed at 12 weeks postpartum)
D: Parents breastfeeding self efficacy (7 days post partum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Neighborhood Alcohol & HIV Prevention in South African Townships (Philani)
Brief Summary: The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with mothers in South Africa, most of whom are at risk delivering babies with fetal alcohol syndrome, babies that are underweight, or babies that are infected with HIV from an HIV-positive mother. The investigators hypothesize that the intervention will reduce the chance of these three health outcomes occurring in the babies and improve the health of the mother.


Options:
A: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
B: Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
C: perinatal mortality (Jan 1999-Dec 2003)
D: Neonatal mortality rate

Answer: A