TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine
Brief Summary: In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a tool for malaria control in 'exceptional conditions when conventional control strategies have failed'. Subsequently, MDA has received little attention until the introduction of artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria transmission by clearing the population of sexual stage parasites, gametocytes, prior to the transmission season. Gametocytes are essential for propagation of the disease and elimination of gametocytes will result in a reduction in malaria transmission. As a consequence, a successful MDA will reduce the burden of disease in a population and is expected to have little influence on the development of protective immunity in areas of low transmission intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on malaria transmission, the incomplete coverage, the relatively high transmission intensity in the area and the migration of individuals between villages. Here, we propose to conduct an MDA study in an area of very low malaria transmission intensity in Tanzania. We use the highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..


Options:
A: Gametocyte carriage (14 days during follow-up)
B: Mean number of days to gametocyte clearance (gametocyte clearance time, GCT) (14 days); Mean (+/- SD) maximal fall in Hb (g/dL) from enrollment to day 28 of follow-up (28 days)
C: Cure rate (63 days)
D: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine
Brief Summary: In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a tool for malaria control in 'exceptional conditions when conventional control strategies have failed'. Subsequently, MDA has received little attention until the introduction of artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria transmission by clearing the population of sexual stage parasites, gametocytes, prior to the transmission season. Gametocytes are essential for propagation of the disease and elimination of gametocytes will result in a reduction in malaria transmission. As a consequence, a successful MDA will reduce the burden of disease in a population and is expected to have little influence on the development of protective immunity in areas of low transmission intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on malaria transmission, the incomplete coverage, the relatively high transmission intensity in the area and the migration of individuals between villages. Here, we propose to conduct an MDA study in an area of very low malaria transmission intensity in Tanzania. We use the highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..


Options:
A: Cure rate (63 days)
B: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)
C: Parasitological outcome after 28 days follow-up (28 days)
D: Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. (2004-March 2007)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine
Brief Summary: In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a tool for malaria control in 'exceptional conditions when conventional control strategies have failed'. Subsequently, MDA has received little attention until the introduction of artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria transmission by clearing the population of sexual stage parasites, gametocytes, prior to the transmission season. Gametocytes are essential for propagation of the disease and elimination of gametocytes will result in a reduction in malaria transmission. As a consequence, a successful MDA will reduce the burden of disease in a population and is expected to have little influence on the development of protective immunity in areas of low transmission intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on malaria transmission, the incomplete coverage, the relatively high transmission intensity in the area and the migration of individuals between villages. Here, we propose to conduct an MDA study in an area of very low malaria transmission intensity in Tanzania. We use the highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..


Options:
A: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)
B: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (14 days from start of treatment)
C: Mean number of days to gametocyte clearance (gametocyte clearance time, GCT) (14 days); Mean (+/- SD) maximal fall in Hb (g/dL) from enrollment to day 28 of follow-up (28 days)
D: Development of sexual stages of P.falciparum (42 days post treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine
Brief Summary: In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a tool for malaria control in 'exceptional conditions when conventional control strategies have failed'. Subsequently, MDA has received little attention until the introduction of artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria transmission by clearing the population of sexual stage parasites, gametocytes, prior to the transmission season. Gametocytes are essential for propagation of the disease and elimination of gametocytes will result in a reduction in malaria transmission. As a consequence, a successful MDA will reduce the burden of disease in a population and is expected to have little influence on the development of protective immunity in areas of low transmission intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on malaria transmission, the incomplete coverage, the relatively high transmission intensity in the area and the migration of individuals between villages. Here, we propose to conduct an MDA study in an area of very low malaria transmission intensity in Tanzania. We use the highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..


Options:
A: Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
B: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (14 days from start of treatment)
C: Mean number of days to gametocyte clearance (gametocyte clearance time, GCT) (14 days); Mean (+/- SD) maximal fall in Hb (g/dL) from enrollment to day 28 of follow-up (28 days)
D: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mass-Drug Administration With a Gametocytocidal Drug Combination, a Model for a Transmission Blocking Vaccine
Brief Summary: In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a tool for malaria control in 'exceptional conditions when conventional control strategies have failed'. Subsequently, MDA has received little attention until the introduction of artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria transmission by clearing the population of sexual stage parasites, gametocytes, prior to the transmission season. Gametocytes are essential for propagation of the disease and elimination of gametocytes will result in a reduction in malaria transmission. As a consequence, a successful MDA will reduce the burden of disease in a population and is expected to have little influence on the development of protective immunity in areas of low transmission intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on malaria transmission, the incomplete coverage, the relatively high transmission intensity in the area and the migration of individuals between villages. Here, we propose to conduct an MDA study in an area of very low malaria transmission intensity in Tanzania. We use the highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..


Options:
A: Prevalence of anaemia (Hb <112g/L) (March 2006)
B: Malaria incidence (the number of OPD attendances with clinical malaria that meet the case definitions as indicated below during the surveillance period ) and the number of hospital admissions with malaria during the surveillance period. (during malaria transmission period); Cost-effectiveness of the delivery system. (during the study period)
C: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)
D: Mean Hb at the end of the high transmission season.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pneumonia
Brief Summary: The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.


Options:
A: Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population (8-15 days after last dose of study drug); Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population (8-15 days after last dose of study drug)
B: Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations (8 to 15 days after last dose of study drug); Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population (8-15 days after last dose of study drug)
C: Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit (5 to 10 days after the last dose of study drug); Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit (5 to 10 days after the last dose of study drug)
D: Antibiotic treatment prescriped at initial visit (Within 2 days of initial visit)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With RRMS
Brief Summary: Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).


Options:
A: Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16 (16 Weeks); Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to Week 40)
B: Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period (Up to Month 24)
C: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
D: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With RRMS
Brief Summary: Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).


Options:
A: Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period (Up to Month 24)
B: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))
C: Annualized Relapse Rate (ARR) at 1 Year (1 Year)
D: Proportion of Subjects Relapsed (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With RRMS
Brief Summary: Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).


Options:
A: Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period (Up to Month 24)
B: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
C: Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months); Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months)
D: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) (Baseline, every 3 month up to the maximum of approximately 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation of a Pharmacy-Intervention to Enhance Prescription and Use of Lipid-Lowering Drugs. A Randomized Trial.
Brief Summary: The purpose of this study is to determine the effectiveness of maximal support of community pharmacies to implement a pharmaceutical care model for improving underprescription and treatment persistence regarding lipid-lowering medication in patients with cardiovascular disease.


Options:
A: Rate of adherence (2 months and 6 months)
B: The percentage of selected (=undertreated) patients receiving at least one prescription for lipid-lowering medication. (six months after the general practitioner received the list with selected patients)
C: Adherence to Antidepressant Medication (At 3 and 6 months)
D: *change in mean diastolic, systolic, and combined diastolic and systolic BP.; *percent of patients with adequately controlled BP.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentered Randomized Controlled Trail to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered
Brief Summary: To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.


Options:
A: Non inferiority among the two groups as far as the improvement in the UDI at two years after treatment is concerned.
B: To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.
C: Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos. (12 Months)
D: Non inferiority of the improvement of the urinary distress inventory one year after treatment. (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration
Brief Summary: This study is a phase 3, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in the US and Canada.


Options:
A: N/A
B: Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) (At week 52)
C: Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) (Baseline and at week 52)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis


Options:
A: Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 5 +/- 1 day); Microbial Eradication of Baseline Bacterial Infection (Day 5 +/- 1 day)
B: Clinical Cure at the Day 4 (EOT)/Exit Visit (Day 4)
C: Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9) (Visit 3 - day 8 or 9); Eradication of Baseline Pathogens (Day 8 or 9) (Visit 3 - Day 8 or day 9)
D: Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 (Day 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2, Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET)
Brief Summary: To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424), administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).


Options:
A: Number of Participants With Adverse Events (AEs) (From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.); Percentage of Participants With Clinical Improvement (CI) Over Time (Week 12, 24, 36, 48 and 60)
B: Overall Response Rate (Assessed at the end of cycle 3)
C: Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48 (Baseline, Week 48)
D: Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
Brief Summary: To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.


Options:
A: Duration of treatment (0 to 42 days)
B: Length of treatment (From initiation of medical treatment through last dose of medication given, up to 100 days)
C: Hospital length of stay (Up to hospital discharge, an anticipated average of 4 weeks)
D: Length of treatment for neonatal abstinence syndrome (duration of the treatment)

Answer: D