TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: HELPING HANDS: a Comparison of Short- and Long Term Effects of Alternative Strategies for Promoting Hand Hygiene in Hospital Nurses.
Brief Summary: Hand hygiene prescriptions are the most important measure in the prevention of hospital acquired infections. Yet compliance rates are generally below 50% of all opportunities for hand hygiene adherence. This study will test the short- and long term effects of two strategies for promoting hand hygiene in hospital nurses


Options:
A: Supportive leadership behaviour questionnaire for assessing head nurses performance (10 months)
B: Institutional delivery (Up to six months)
C: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)
D: Change in team cohesion (Change from baseline to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: HELPING HANDS: a Comparison of Short- and Long Term Effects of Alternative Strategies for Promoting Hand Hygiene in Hospital Nurses.
Brief Summary: Hand hygiene prescriptions are the most important measure in the prevention of hospital acquired infections. Yet compliance rates are generally below 50% of all opportunities for hand hygiene adherence. This study will test the short- and long term effects of two strategies for promoting hand hygiene in hospital nurses


Options:
A: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)
B: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)
C: RT-PCR analysis (two weeks)
D: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Vitamin D Supplementation on the Incidence of Pneumonia in Children in Afghanistan: a Randomized Controlled Trial
Brief Summary: Background: Pneumonia is the leading cause of childhood mortality, accounting for 19% of the 10.6 million deaths that occur each year1. Case-control studies from Ethiopia2 and India3 suggest that sub-clinical vitamin D deficiency may increase ten times the risk of pneumonia in children. We postulate that controlling childhood vitamin D deficiency has the potential to dramatically reduce the incidence of pneumonia and save \>700,000 lives each year since vitamin D deficiency is widespread in developing countries.

Aim: To investigate whether 3-monthly oral supplementation of 100,000iu vitamin D reduces pneumonia and its consequences among children aged 1-12 months (followed for 18 months), living in a deprived area of Kabul, Afghanistan, where \>70% of young children are vitamin D deficient (\<8ng/dl). The effect of vitamin D on the incidence of other diseases, in particular diarrhea and rickets will also be investigated.

Methods: Randomised double-blind placebo-controlled trial: 3000 children will be randomised to receive either 6 doses of vitamin D or placebo. The first dose will be given at the start of autumn and the second and subsequent doses every 3 months thereafter; children will be followed for 18 months. Incidence of pneumonia will be ascertained though weekly home visits (active surveillance) and from attendances and admissions at the trial clinic and wards in the hospital serving the study area (passive surveillance).


Options:
A: incidence of pneumonia (18 months)
B: Serum vitamin D levels (6 months); Tuberculin Skin Test conversion (6 monhs)
C: All-cause mortality and diarrheal morbidity (age 6 weeks to age 24 months)
D: EASI score (1 month); Investigator Global Assessment (IGA) (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Vitamin D Supplementation on the Incidence of Pneumonia in Children in Afghanistan: a Randomized Controlled Trial
Brief Summary: Background: Pneumonia is the leading cause of childhood mortality, accounting for 19% of the 10.6 million deaths that occur each year1. Case-control studies from Ethiopia2 and India3 suggest that sub-clinical vitamin D deficiency may increase ten times the risk of pneumonia in children. We postulate that controlling childhood vitamin D deficiency has the potential to dramatically reduce the incidence of pneumonia and save \>700,000 lives each year since vitamin D deficiency is widespread in developing countries.

Aim: To investigate whether 3-monthly oral supplementation of 100,000iu vitamin D reduces pneumonia and its consequences among children aged 1-12 months (followed for 18 months), living in a deprived area of Kabul, Afghanistan, where \>70% of young children are vitamin D deficient (\<8ng/dl). The effect of vitamin D on the incidence of other diseases, in particular diarrhea and rickets will also be investigated.

Methods: Randomised double-blind placebo-controlled trial: 3000 children will be randomised to receive either 6 doses of vitamin D or placebo. The first dose will be given at the start of autumn and the second and subsequent doses every 3 months thereafter; children will be followed for 18 months. Incidence of pneumonia will be ascertained though weekly home visits (active surveillance) and from attendances and admissions at the trial clinic and wards in the hospital serving the study area (passive surveillance).


Options:
A: Time taken for recovery from severe pneumonia (12 months)
B: Serum calcium (at each dose change)
C: incidence of pneumonia (18 months)
D: Change in serum level of 25hydroxycholecalciferol (25(OH)D) (At baseline and 7 days after vitamin D3 (Cholecalciferol) injection)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Vitamin D Supplementation on the Incidence of Pneumonia in Children in Afghanistan: a Randomized Controlled Trial
Brief Summary: Background: Pneumonia is the leading cause of childhood mortality, accounting for 19% of the 10.6 million deaths that occur each year1. Case-control studies from Ethiopia2 and India3 suggest that sub-clinical vitamin D deficiency may increase ten times the risk of pneumonia in children. We postulate that controlling childhood vitamin D deficiency has the potential to dramatically reduce the incidence of pneumonia and save \>700,000 lives each year since vitamin D deficiency is widespread in developing countries.

Aim: To investigate whether 3-monthly oral supplementation of 100,000iu vitamin D reduces pneumonia and its consequences among children aged 1-12 months (followed for 18 months), living in a deprived area of Kabul, Afghanistan, where \>70% of young children are vitamin D deficient (\<8ng/dl). The effect of vitamin D on the incidence of other diseases, in particular diarrhea and rickets will also be investigated.

Methods: Randomised double-blind placebo-controlled trial: 3000 children will be randomised to receive either 6 doses of vitamin D or placebo. The first dose will be given at the start of autumn and the second and subsequent doses every 3 months thereafter; children will be followed for 18 months. Incidence of pneumonia will be ascertained though weekly home visits (active surveillance) and from attendances and admissions at the trial clinic and wards in the hospital serving the study area (passive surveillance).


Options:
A: Number of Infants With Recurrent Wheezing (up to 12 months adjusted age)
B: Maternal and Neonatal complications (six months post enrolement)
C: incidence of pneumonia (18 months)
D: Vitamin D plasma concentrations (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy
Brief Summary: The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.


Options:
A: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)
B: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)
C: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity (From the first dose of study drug administration up to Week 24); Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Vital Signs: Pulse Rate (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Vital Signs: Temperature (Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36); Change From Baseline in Electrocardiogram (ECGs) (Baseline, Week 12 and 36); Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels (Baseline up to Week 36); Number of Subjects With Positive Neutralizing Antibody (NAb) (Baseline, Week 12 and 36)
D: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy
Brief Summary: The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.


Options:
A: graft survival (1 year)
B: Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria). (Two years); Average of Renal Function (Two years)
C: Incidence and severity of biopsy-proven acute rejection at 1 year. (1 year)
D: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy
Brief Summary: The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.


Options:
A: ARR - PDEs (Baseline to Month 36)
B: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
C: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
D: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy
Brief Summary: The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.


Options:
A: Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis (day 28); Change in EDSS in patients who present a relapse from different type or unknown topography (day 28)
B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) (From Baseline until the end of the study (up to a maximum duration of 5.6 years)); Number of Participants With Infusion-Associated Reactions (IAR) (Within 24 hours of any alemtuzumab infusion); Number of Participants With Adverse Events of Special Interest (AESI) (From Baseline until the end of the study (up to a maximum duration of 5.6 years)); Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (From Baseline until the end of the study (up to a maximum duration of 5.6 years))
C: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
D: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Trial of Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer
Brief Summary: The purpose of this study is to determine whether the combination of topotecan, cisplatin and bevacizumab is effective in the treatment of recurrent or persistent cervical cancer


Options:
A: overall survival (During the study conduct)
B: Overall Survival (From entry into the study to death or the date of last contact, assessed up to 5 years); Progression-free Survival (From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)); Tumor Response (Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.); To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study. (From date of enrollment until 30 days after treatment completion)
C: Progression-free survival (48 months); Overall survival (48 months)
D: Anti-tumor Activity as Measured by Surviving Progression-free (Progression-free survival at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Patients With Advanced Gastric Cancer
Brief Summary: This study will compare treatment with bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin, as first-line therapy in patients with locally advanced or metastatic gastric cancer who had not received prior chemotherapy for advanced or metastatic disease.


Options:
A: Overall Survival Time (OS) (Randomization up to 27.5 months)
B: Overall Survival (From randomization until death, up to 26 months)
C: Progression-free survival rate (at 24weeks from patient enrollment)
D: Overall survival (every course for first three courses, then every other course)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Patients With Advanced Gastric Cancer
Brief Summary: This study will compare treatment with bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin, as first-line therapy in patients with locally advanced or metastatic gastric cancer who had not received prior chemotherapy for advanced or metastatic disease.


Options:
A: The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1. (Average time period: up to one year (participants are followed until progression or death))
B: Progression Free Survival (PFS) (22 months)
C: Overall Survival (OS) (approx. 12 month)
D: Overall Survival (From randomization until death, up to 26 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Patients With Advanced Gastric Cancer
Brief Summary: This study will compare treatment with bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin, as first-line therapy in patients with locally advanced or metastatic gastric cancer who had not received prior chemotherapy for advanced or metastatic disease.


Options:
A: Overall Survival (OS) (2.5 years)
B: Overall Survival (From randomization until death, up to 26 months)
C: Progression-free Survival (Treatment will continue until disease progression or intolerable toxicity, up to 2 years)
D: Overall Survival (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Carotid Plaque Screening on Smoking Cessation and Control of Other Cardiovascular Risk Factors: A Randomized Controlled Trial.
Brief Summary: The purpose of this study is to determine the impact of carotid plaque screening on smoking cessation and control of other cardiovascular risk factors.


Options:
A: The primary measure of results will be the differences in smoking cessation rates between intervention and control groups (12 months after been conducted the intervention)
B: Biologically confirmed tobacco cessation (6 months)
C: Smoking abstinence: one-week point prevalence abstinence, ascertained by self-report and confirmed by exhaled carbon monoxide (CO) and by the level of serum cotinine (1 year, 3 years)
D: Preoperative Carbon Monoxide Levels (the morning of surgery); Exhaled CO Level Measured Immediately Prior to Surgery (The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Prospective Randomized Trial Comparing Radiosurgery With Versus Without Whole Brain Radiotherapy for 1-3 Newly Diagnosed Brain Metastases
Brief Summary: The goal of this clinical research study is to learn if your thinking ability (cognitive function) will be better preserved by delivering whole brain radiation therapy immediately after radiosurgical treatment of 1-3 brain metastases or to carefully observe patients after radiosurgery and hold back whole brain radiation therapy until the disease comes back.


Options:
A: Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) (Baseline and 4 months from start of treatment)
B: Progression-free-survival (6 months)
C: Change in cognitive composite score (baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training))
D: Cognitive Decline (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD
Brief Summary: The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.


Options:
A: Change in disease activity. (6 months)
B: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
C: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)
D: Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6. (Baseline, End of single blind period (Week 6)); Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6. (Baseline, End of single blind period (Week 6))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD
Brief Summary: The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.


Options:
A: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)
B: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)
C: Mean 48-week Change in DAS28 (48 weeks after baseline assessment)
D: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)

Answer: A