TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Antipsychotic Medication Extended Dosing Study
Brief Summary: In patients stabilized on their antipsychotic and demonstrating evidence of good clinical response, there will not be a significant change in symptoms if their medication is decreased to every 2 days rather than daily. This decrease in antipsychotic exposure will lead to a reduction in side effects, as well as improved subjective response to treatment.


Options:
A: Risperidone effectiveness is measured by time to relapse within the 52 week period.
B: Clinical Global Impression every 2 weeks; Simpson and Angus Rating Scale for Extrapyramidal Effects every 2 weeks; Barnes Rating Scale for Drug-Induced Akathisia every 2 weeks; Abnormal Involuntary Movement Scale every 2 weeks; Drug Attitude Inventory every 2 weeks; Calgary Depression Scale for Schizophrenia every 2 weeks; Brief Psychiatric Rating Scale every 2 weeks
C: The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS). (12 weeks)
D: Relapse (Every 2 weeks up to 26 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Antipsychotic Medication Extended Dosing Study
Brief Summary: In patients stabilized on their antipsychotic and demonstrating evidence of good clinical response, there will not be a significant change in symptoms if their medication is decreased to every 2 days rather than daily. This decrease in antipsychotic exposure will lead to a reduction in side effects, as well as improved subjective response to treatment.


Options:
A: relapse rate (1 year)
B: Rehospitalizations and psychotic relapse at two years
C: Clinical Global Impression every 2 weeks; Simpson and Angus Rating Scale for Extrapyramidal Effects every 2 weeks; Barnes Rating Scale for Drug-Induced Akathisia every 2 weeks; Abnormal Involuntary Movement Scale every 2 weeks; Drug Attitude Inventory every 2 weeks; Calgary Depression Scale for Schizophrenia every 2 weeks; Brief Psychiatric Rating Scale every 2 weeks
D: relapse rate (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.
Brief Summary: Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates, has been implicated in many disease processes, especially age-related disorders. Many trials investigating use of antioxidants in protecting different tissues against oxidative stress have been conducted, but the results are ambiguous.

Inflammation is generally associated with enhanced oxidative stress and widespread endothelial dysfunction. In the present study, the infusion of LPS, which is a cell wall component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock, will be used as a standardized experimental model of systemic inflammatory response in humans. The assessment of outcome parameters will include measurements of ocular blood flow, forearm blood flow and plasma concentration of cytokines. Measurements of ocular hemodynamics provide an unique chance to investigate local blood flow in humans non-invasively. Moreover, the retina is especially susceptible to oxidative stress because of its high consumption of oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light. Evidence from literature clearly supports a role for oxidative stress in pathophysiology of several ocular diseases including diabetic retinopathy and age-related macular degeneration. To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus. The measurement of forearm blood flow will be use to assess endothelial function. The main study objective is to investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS administration.


Options:
A: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
B: Retinal blood flow (in total 8x on 2 study days)
C: Cardiovascular disease; Cancer
D: A combination of CVD mortality non fatal MI and Stoke at a 4 year follow up.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.
Brief Summary: Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates, has been implicated in many disease processes, especially age-related disorders. Many trials investigating use of antioxidants in protecting different tissues against oxidative stress have been conducted, but the results are ambiguous.

Inflammation is generally associated with enhanced oxidative stress and widespread endothelial dysfunction. In the present study, the infusion of LPS, which is a cell wall component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock, will be used as a standardized experimental model of systemic inflammatory response in humans. The assessment of outcome parameters will include measurements of ocular blood flow, forearm blood flow and plasma concentration of cytokines. Measurements of ocular hemodynamics provide an unique chance to investigate local blood flow in humans non-invasively. Moreover, the retina is especially susceptible to oxidative stress because of its high consumption of oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light. Evidence from literature clearly supports a role for oxidative stress in pathophysiology of several ocular diseases including diabetic retinopathy and age-related macular degeneration. To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus. The measurement of forearm blood flow will be use to assess endothelial function. The main study objective is to investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS administration.


Options:
A: Retinal blood flow (in total 8x on 2 study days)
B: Focal Electroretinogram Amplitude and Phase (6 months)
C: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
D: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reshaping Exercise Habits and Beliefs (REHAB): Pilot Testing of a Behavioral Intervention to Improve Mobility After Stroke
Brief Summary: Regular exercise has been demonstrated to improve muscle strength, balance, coordination as well as improve cardiovascular fitness levels and overall quality of life in stroke survivors. This study is designed to test the feasibility and effectiveness of a 12-week intervention to education and encourage stroke survivors to exercise following discharge from rehabilitation settings using a walking program and targeted functional activity homework.


Options:
A: Ambulatory Activity Profile (6 months)
B: Change from baseline in Physical activity levels - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in Physical activity levels - Human Activity Profile (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in sedentary behavior - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up)
C: Dual-task cost on gait speed (4 weeks)
D: Physical activity of the lower and upper extremities (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reshaping Exercise Habits and Beliefs (REHAB): Pilot Testing of a Behavioral Intervention to Improve Mobility After Stroke
Brief Summary: Regular exercise has been demonstrated to improve muscle strength, balance, coordination as well as improve cardiovascular fitness levels and overall quality of life in stroke survivors. This study is designed to test the feasibility and effectiveness of a 12-week intervention to education and encourage stroke survivors to exercise following discharge from rehabilitation settings using a walking program and targeted functional activity homework.


Options:
A: Maximum torque around the knee joint; gait velocity
B: Steps Per Day (Change from Baseline to 3 months (Post)); Steps Per Day (Change from 3 months (Post) to 6 months); Steps Per Day (Change from 3 months (Post) to 12 months)
C: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)
D: Ambulatory Activity Profile (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas Aeruginosa
Brief Summary: This is a study to examine the safety, effect on lung function, and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in 6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa.


Options:
A: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (Baseline and end of treatment Course 1 (Day 28)); Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses (Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20))
B: Proportion of children with radiologically-defined bronchiectasis (at three years of age); The proportion of lung tissue affected by disease (at three years of age)
C: Change in FEV1 From Baseline to End of Treatment at Day 168 (change from baseline to day 168)
D: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas Aeruginosa
Brief Summary: This is a study to examine the safety, effect on lung function, and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in 6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa.


Options:
A: the prevalence of nasopharyngeal carriage of the newborn of any of the following bacteria: 1) Group B Streptococci (GBS) , 2) S.pneumoniae and 3) S.aureus (6 days)
B: Change in FEV1 From Baseline to End of Treatment at Day 168 (change from baseline to day 168)
C: The primary efficacy variable was the percentage of patients who had a 20 percent improvement according to American College of Rheumatology (ACR) criteria (an ACR 20 response) at six months.
D: Comparison of number of participants with very good partial response or better response after three courses of VCD combined with clarithromycin or placebo (10 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Indomethacin on the Progression of Alzheimer's Disease
Brief Summary: The purpose of this study is determine whether indomethacin is able to retard disease progression in patients with mild to moderate Alzheimer's disease.


Options:
A: Score on the Cognitive subscale of the Alzheimer's Disease Assessment Scale at 12 months.
B: N/A
C: To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. (3 years)
D: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness, Cost and Cost Effectiveness of Intermittent Preventive Treatment or Screening and Treatment of Malaria in Pregnancy Among Women Using Long Lasting Insecticide Treated Bed Net: a Randomised Controlled Trial.
Brief Summary: Among the best practices recommended for malaria control during pregnancy is ensuring effective case management of malaria illness. However, this is often not practiced because (1) malaria infection in pregnancy is often asymptomatic, (2) peripheral parasitaemia may be absent even when the placenta is heavily parasitized, (3) implementing diagnosis and treatment of malaria within a routine antenatal service may be difficult and (4) antimalarial treatment options available to pregnant women are limited due to resistance to chloroquine(CQ) and sulfadoxine-pyrimethamine(SP0 and paucity of safety and efficacy data on other antimalarial drugs in pregnancy, particularly artemisinin combination treatments (ACT). Therefore the commonest recommended practice in pregnancy is the administration of SP as intermittent preventive treatment (SP-IPTp). However, the effectiveness of SP-IPTp has been questioned because parasite resistance to SP is spreading rapidly across sub-Saharan Africa.

This is a three-arm open label randomised control non-inferiority trial of insecticide-treated nets(ITN) plus rapid diagnostic test(RDT) screening, and treatment with SP or amodiaquine plus artimisinin(AQ+AS) versus ITN plus IPTp using SP. It is to be carried out in pregnant women of all parities presenting at enrolling antenatal clinics with a gestation of 16 to 20 weeks at their first booking. The key objectives are to demonstrate that (1) the prevalence of severe anaemia (Hb \< 8g/dl) at 34 to 36 weeks of gestation (2) the prevalence of low birth weight (BW \< 2500g) at delivery or within 72 hours after delivery (3) the prevalence of placenta parasitaemia and (4) the incidence of serious and non-serious adverse events in the ITN plus RDT screening and treatment arm are not greater than those in the ITN plus IPTp arm. Alongside the clinical assessments, health care cost assessments will be done to determine the cost-effectiveness of the two delivery strategies measured as cases of severe maternal anaemia averted.


Options:
A: Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
B: Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight
C: Prevalence of severe maternal anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation. (At 34 to 36 weeks of gestation)
D: mean birthweight (April 2004-Jan 2007); prevalence of low birthweight (April 2004 - Jan 2007)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine (GSK 357941A) in Healthy Infants.
Brief Summary: This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.


Options:
A: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)
B: Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. (30 Days post-dose 3 vaccination); Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) (30 Days post-dose 3 vaccination); Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. (30 Days post-dose 3 vaccination.)
C: Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody (At Month 3)
D: Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine (GSK 357941A) in Healthy Infants.
Brief Summary: This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.


Options:
A: Percentage of Participants Developing New Grade >=3 Adverse Events (From study entry until at least 42 days after third vaccination); Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1. (Prior to first vaccination and at least 14 days after third vaccination)
B: 1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
C: Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL. (At Month 5 (One month after Dose 3 of co-administered vaccines)); Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies. (At Month 5 (One month after Dose 3 of co-administered vaccines))
D: Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody (At Month 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine (GSK 357941A) in Healthy Infants.
Brief Summary: This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.


Options:
A: Number of Participants With Vaccine Induced Reactions (7 days following each dose); Number of Participants With Serious Adverse Events (within 28 days of a study dose and at any time); Number of Participants Reporting Any Non-Serious Adverse Event (6 mo following first vaccination); Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse. (Baseline to day 84); Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses (Baseline to day 84); Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8]) (Baseline to Day 84)
B: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)
C: Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody (At Month 3)
D: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Trial of Thalidomide Plus Zoledronic Acid Versus Zoledronic Acid Alone in Patients With Early Stage Multiple Myeloma
Brief Summary: RATIONALE: Zoledronate may prevent bone loss and stop the growth of cancer cells in bone. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet know whether giving zoledronate together with thalidomide is more effective than zoledronate alone in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying zoledronate and thalidomide see how well they work compared with zoledronate alone in treating patients with early stage multiple myeloma.


Options:
A: Time to next need treatment (6 months)
B: Time to the First On-Study Skeletal-Related Event (Non-Inferiority) (up to 33 months)
C: Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire
D: Time to Disease Progression (TTP) (randomization to progression (up to 5 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Falls Prevention for People With Increased Risk of Fractures as a Result of Osteoporosis: a Randomized Controlled Study on the Effects of a Modified Program
Brief Summary: The purpose of this study is to determine wether a falls prevention program can reduce fall incidence in people with osteoporosis.


Options:
A: Fall incidence, which is measured by monthly fall registration cards
B: Cognitive Performance of Executive Function (12 months)
C: Change in the number of falls (Baseline, 6 Months)
D: health costs after 18 months (baseline 18 month control); falls after 18 months (daily records, analysis after 18 months); Bone parameters after 6, 12 and 18 months (baseline, 6, 12, 18 month-control)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.
Brief Summary: Primary objective:

To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.

Secondary objectives: NA


Options:
A: N/A
B: N/A
C: Phase A: Number of Subjects With Confirmed Varicella Case (From 42 days post dose 2 until the end of Phase A)
D: Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year; Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination

Answer: B