TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis? A Cluster Randomised Controlled Trial in an East London Primary Care Trust
Brief Summary: This randomised controlled trial tests whether screening people registering with general practices cost-effectively increases the detection of tuberculosis. The study objectives are to:

1. recruit, and randomise with stratification, forty Hackney general practices to usual activity or screening for TB primarily during registration health checks (by practice nurses and GPs) and transfer-in visits for children (by health visitors)
2. implement a screening programme comprising education, resources and clinical support for intervention practices using proven behaviour change strategies
3. gather outcomes and costs
4. build research capacity within an ELENoR Primary Care Research Team and across a Primary Care Trust.

The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level. Secondary outcomes are rates of prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and costs. Analyses will be by intention to treat.


Options:
A: Hospital rate of permanent colostomy; Hospital rate of local recurrence
B: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
C: The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level.
D: Episiotomies; Oxytocin use in third stage of labor

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind Trial of Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
Brief Summary: While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine.

Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.


Options:
A: Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 0 to week 8 of the study); Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 9 to week 16 of the study); Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 0 to week 8 of the study); Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 9 to week 16 of the study)
B: Young Mania Rating Scale; Hamilton Depression Rating Scale (HAM-D), 17-item version Hamilton Rating Scale for Anxiety (HAM-A).; Clinical Global Impression Scale CGI-BP (41); Affective Morbidity Index (42)
C: Montgomery-Asberg Depression Rating Score (MADRS) (Baseline & week 8)
D: Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients
Brief Summary: In a previous study, the investigators showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality in adult intensive care patients. Whether this intervention also improves prognosis of pediatric intensive care patients remains unknown. The current prospective, randomized, controlled study will asses the impact of intensive insulin therapy on outcome of patients in a pediatric intensive care unit. On admission patients will be randomly assigned to either strict normalization of blood glucose according age adjusted values or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl to maintain blood glucose levels between 180-200 mg/dl.


Options:
A: The primary outcome is growth velocity for first 28 days of life calculated as: weight gain, head circumference, length
B: Length of stay in ICU and length of stay in the hospital. (2 years)
C: ICU-Free Days (Study day 28)
D: Reduction of inflammation (during ICU stay to day 5); duration of dependency on intensive care (days in ICU) (time in ICU)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism
Brief Summary: The best management in selected patients of pulmonary Embolism (PE) should be at home. The efficacy and safety treatment´s at home versus at hospital should be similar and quality of life should be better. Our purpose is to demostrate that Low weight molecular heparin (LWMH) at home for PE is at least as effective and safe at home as at hospital


Options:
A: 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE (90 Days)
B: -Thromboembolic recurrences; -Bleeding Complications; -Deaths
C: Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) (within 3 months of randomization)
D: The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism
Brief Summary: The best management in selected patients of pulmonary Embolism (PE) should be at home. The efficacy and safety treatment´s at home versus at hospital should be similar and quality of life should be better. Our purpose is to demostrate that Low weight molecular heparin (LWMH) at home for PE is at least as effective and safe at home as at hospital


Options:
A: Anxiety and depression (HADS) (At 1 month, 3 months and 12 months, change from baseline)
B: -Thromboembolic recurrences; -Bleeding Complications; -Deaths
C: MRS (6 months)
D: Change in HADS-A score from baseline to three months follow-up (Three months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism
Brief Summary: The best management in selected patients of pulmonary Embolism (PE) should be at home. The efficacy and safety treatment´s at home versus at hospital should be similar and quality of life should be better. Our purpose is to demostrate that Low weight molecular heparin (LWMH) at home for PE is at least as effective and safe at home as at hospital


Options:
A: Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) (within 3 months of randomization)
B: 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE (90 Days)
C: -Thromboembolic recurrences; -Bleeding Complications; -Deaths
D: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy: Hoosier Oncology Group GU02-41
Brief Summary: Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.


Options:
A: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 (13 weeks)
B: Numbers of SRE or Death Occurred Cumulatively (36 months)
C: Time to First Skeletal Related Event (Up to 10 years)
D: Overall survival (1:Not applicable)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy: Hoosier Oncology Group GU02-41
Brief Summary: Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.


Options:
A: Time to the First On-Study SRE (Non-inferiority) (Up to 40.5 months)
B: Numbers of SRE or Death Occurred Cumulatively (36 months)
C: Overall survival (1:Not applicable)
D: Time to First Skeletal Related Event (Up to 10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-Blind, Multi-Center, Comparator Study Evaluating the Safety and Efficacy of Dexmedetomidine Compared to IV Midazolam in ICU Subjects Requiring Greater Than Twenty-Four Hours of Continuous Sedation
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.


Options:
A: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required (RASS score will be assessed approximately 2 hourly during the treatment period and during the 48-hour follow-up period); Duration of mechanical ventilation the number of days the patient receives mechanical ventilation will be recorded (This variable will be dependent on the individual patient and the number of days they require mechanical ventilation .)
B: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)
C: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. (2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up); Duration of mechanical ventilation (Start and stop times of mechanical ventilation while the patient is treated in the ICU)
D: Percent of Subjects Requiring Rescue Midazolam for Sedation (During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-Blind, Multi-Center, Comparator Study Evaluating the Safety and Efficacy of Dexmedetomidine Compared to IV Midazolam in ICU Subjects Requiring Greater Than Twenty-Four Hours of Continuous Sedation
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.


Options:
A: Days Free of Delirium and Coma (Admission through day 8 of stay)
B: Hospital Mortality to Day 60. (60 days after randomization)
C: Ventilator-free hours (7 days following randomisation)
D: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-Blind, Multi-Center, Comparator Study Evaluating the Safety and Efficacy of Dexmedetomidine Compared to IV Midazolam in ICU Subjects Requiring Greater Than Twenty-Four Hours of Continuous Sedation
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.


Options:
A: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)
B: Feasibility: Study adherence (1 year)
C: Cognitive function (3 months after discharge from ICU)
D: Ventilator free-days (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-Blind, Multi-Center, Comparator Study Evaluating the Safety and Efficacy of Dexmedetomidine Compared to IV Midazolam in ICU Subjects Requiring Greater Than Twenty-Four Hours of Continuous Sedation
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.


Options:
A: Ventilator free days
B: Ventilator free-days (28 days)
C: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
D: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-Blind, Multi-Center, Comparator Study Evaluating the Safety and Efficacy of Dexmedetomidine Compared to IV Midazolam in ICU Subjects Requiring Greater Than Twenty-Four Hours of Continuous Sedation
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.


Options:
A: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)
B: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required (RASS score will be assessed approximately 2 hourly during the treatment period and during the 48-hour follow-up period); Duration of mechanical ventilation the number of days the patient receives mechanical ventilation will be recorded (This variable will be dependent on the individual patient and the number of days they require mechanical ventilation .)
C: Ventilator free days
D: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy of Fluviral™ Influenza Vaccine in Healthy Adults 18 to 49 Years of Age
Brief Summary: The goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe enough to limit normal daily activities and that are shown by virus culture to be caused by influenza viruses. The study will also examine the safety of the vaccine and collect measurements of the immune system responses produced by the vaccine.


Options:
A: CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection (2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009)
B: Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.
C: Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age; local and systemic reactions within 2 weeks of vaccination
D: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). (Days 1-8); Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: International Multicenter Trial for the Evaluation of a Four-Drug Fixed Dose Combined Tablet Daily in the Initial Intensive Phase of Chemotherapy Followed by a Two-Drug Fixed Dose Combined Tablet Three Times a Week in the Continuation Phase for the Treatment of Pulmonary Tuberculosis
Brief Summary: The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding adherence and facilitating directly observed treatment. Recent bioavailability studies of four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing the efficacy of this compound, when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by four months treatment with a two-drug FDC of rifampicin and isoniazid.


Options:
A: Efficacy : combined rate of failure at the end of treatment and relapse by 30 months.; Safety : occurrence of serious adverse events at any time during chemotherapy
B: Incident tuberculosis (During enrolment)
C: Development of confirmed, probable, or possible active pulmonary or extrapulmonary tuberculosis (TB) (6/2008)
D: TB incidence (Jan 2003 to July 2011); Mortality (Jan 2003 to July 2011)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis
Brief Summary: Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.


Options:
A: Final cure rate at six months after the end of 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: Final Clinical Cure Rate (Day 42, 98, and 168)
D: Wound closure time (75 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis
Brief Summary: Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.


Options:
A: Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) (180 days); Safety of WR 279,396 (AEs and SAEs) (180 days)
B: Final Clinical Cure Rate (Day 42, 98, and 168)
C: (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.
D: Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure (Assessment of cure is made at 2 months after treatment)

Answer: C