TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
Brief Summary: The purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. At present, no such studies of free-living subjects have been performed. The specific aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat diet will produce greater weight loss/body fat loss and more successful weight maintenance than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an improved lipid profile and better glycemic control than a high carbohydrate diet.


Options:
A: body weight (prior to and after 4, 8, and 12 months of dieting)
B: Dietary intake (6 month)
C: weight loss
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes
Brief Summary: The purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. At present, no such studies of free-living subjects have been performed. The specific aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat diet will produce greater weight loss/body fat loss and more successful weight maintenance than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an improved lipid profile and better glycemic control than a high carbohydrate diet.


Options:
A: Change in body weight (measured at Year 2)
B: N/A
C: Hemoglobin A1c (22 weeks)
D: body weight (prior to and after 4, 8, and 12 months of dieting)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
Brief Summary: Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.


Options:
A: Mortality rate in children aged 2-11 months (estimated by birth history questioning) (Up to 12 months of age); Incidence of severe adverse drug reactions following IPTi (as detected by spontaneous, passive reporting system) (All age groups, particular attention in under 2 year olds)
B: N/A
C: incidence rate of clinical malaria; in vivo adequate clinical and parasitological response of P. falciparum to SP
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: Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
Brief Summary: Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.


Options:
A: The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children (Onset of IPT to end of malaria season)
B: N/A
C: Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants (6 to 24 months of age); Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants (Randomization to 24 months of age)
D: incidence rate of clinical malaria; in vivo adequate clinical and parasitological response of P. falciparum to SP

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
Brief Summary: Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.


Options:
A: Risk of Parasitaemia (Unadjusted by Genotyping) (after 42 days of follow-up)
B: incidence rate of clinical malaria; in vivo adequate clinical and parasitological response of P. falciparum to SP
C: 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)
D: Prevalence of anaemia (Hb <112g/L) (March 2006)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management
Brief Summary: Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.


Options:
A: Prevalence of drug resistance
B: Clinical malaria in the first year of life
C: incidence rate of clinical malaria; in vivo adequate clinical and parasitological response of P. falciparum to SP
D: Parasite clearance time

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin
Brief Summary: This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.


Options:
A: Glycosylated Haemoglobin A1c (HbA1c) (after 52 weeks of treatment)
B: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (Week 0, Week 26); Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (Week 0 to Week 52 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes (Week 0 to Week 52 + 7 days follow up)
C: Insulin Detemir-insulin Aspart Cross-reacting Antibodies (week 0, 52 and 104)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial on the Effectiveness of Inhaled Nitrous Oxide for Pain Relief During ROP Screening Exam in the Pre-term Infant
Brief Summary: The primary objective of the proposed study is to show that inhaled equimolar mixture of oxygen and nitrous oxide (EMONO) will reduce pain associated with retinal exam in the preterm infant, as compared to the current standard treatment (oral sucrose and topical anaesthesia).

The investigators also aim to show that EMONO can be used safely in preterm neonates undergoing retinal exam, and will not result in any increase in apnea, bradycardia, or desaturation in the 24 hours following the exam. Finally, the investigators aim to show that EMONO will keep the infant calm, and make retinal examination easier and less traumatic.


Options:
A: Pain Profile (During the Procedure)
B: skin blood flow response (perfusion units, PU) (immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points))
C: Pain-specific event related potential (Isolated within the one-minute window post-procedure.)
D: The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score (PIPP score before, during and after eye exam)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial on the Effectiveness of Inhaled Nitrous Oxide for Pain Relief During ROP Screening Exam in the Pre-term Infant
Brief Summary: The primary objective of the proposed study is to show that inhaled equimolar mixture of oxygen and nitrous oxide (EMONO) will reduce pain associated with retinal exam in the preterm infant, as compared to the current standard treatment (oral sucrose and topical anaesthesia).

The investigators also aim to show that EMONO can be used safely in preterm neonates undergoing retinal exam, and will not result in any increase in apnea, bradycardia, or desaturation in the 24 hours following the exam. Finally, the investigators aim to show that EMONO will keep the infant calm, and make retinal examination easier and less traumatic.


Options:
A: Pain measured on PIPP (Premature Infant Pain Profile) scale (4 week to complete)
B: Pain scores assessed by the PIPP score (The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.)
C: The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score (PIPP score before, during and after eye exam)
D: Painful response as assessed by PIPP Scale (Pre procedure,Intra procedure,post 30 sec,post 1 min,post 2 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Estrogen Replacement on Atherosclerosis Progression in Recently Menopausal Women
Brief Summary: The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.


Options:
A: Rate of change of carotid intimal medial thickness by ultrasound (Measured at screening, 12, 24, 36, and 48 months)
B: N/A
C: All-cause dementia and Mild Cognitive Impairment (Measured once a year)
D: Global disease activity throughout the follow-up period, estimated as the area under the SLEDAI-curve

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cluster Randomised Trial to Evaluate the Impact of Routine Home Visits to Provide a Package of Essential Newborn Care Interventions in the Third Trimester of Pregnancy and the 1st Week of Life on Neonatal Mortality in Rural Ghana
Brief Summary: Introduction: Just under four million infants die each year before reaching one month of age; neonatal deaths now account for 38% of the 10.8 million deaths among children younger than 5 years of age. Tackling neonatal mortality is essential if the millennium development goal to reduce by 2015 overall child mortality by two-thirds from its levels in 1990 is to be achieved. Postnatal care for mothers and neonates in developing countries, particularly when deliveries occur at home, is either not available or is of poor quality. Trained community workers are considered by many to be pivotal to newborn care in the community, as they can act as catalysts for community actions and also be providers of care.Reductions in neonatal mortality have been slower in Sub-Saharan Africa than in any other region, and no evaluations of the effectiveness and feasibility of home visits in reducing neonatal mortality have been conducted.

Trial aim: To link with the Ghana Health Service to develop a feasible and sustainable intervention to improve newborn care practices and careseeking during pregnancy and childbirth, and to identify and refer very low birth weight and/or sick babies, through routine home-visits by community health workers (CHWs), and by so doing reduce neonatal mortality.


Options:
A: Exclusive breastfeeding among children 0-6 months of age (4 years); Child heights and weights (children 24-60 months of age) (4 years); Complementary feeding for children 6-23.9 months of age (4 years)
B: N/A
C: Neonatal mortality rate
D: Neonatal mortality rate (deaths within 28 days of birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cluster Randomised Trial to Evaluate the Impact of Routine Home Visits to Provide a Package of Essential Newborn Care Interventions in the Third Trimester of Pregnancy and the 1st Week of Life on Neonatal Mortality in Rural Ghana
Brief Summary: Introduction: Just under four million infants die each year before reaching one month of age; neonatal deaths now account for 38% of the 10.8 million deaths among children younger than 5 years of age. Tackling neonatal mortality is essential if the millennium development goal to reduce by 2015 overall child mortality by two-thirds from its levels in 1990 is to be achieved. Postnatal care for mothers and neonates in developing countries, particularly when deliveries occur at home, is either not available or is of poor quality. Trained community workers are considered by many to be pivotal to newborn care in the community, as they can act as catalysts for community actions and also be providers of care.Reductions in neonatal mortality have been slower in Sub-Saharan Africa than in any other region, and no evaluations of the effectiveness and feasibility of home visits in reducing neonatal mortality have been conducted.

Trial aim: To link with the Ghana Health Service to develop a feasible and sustainable intervention to improve newborn care practices and careseeking during pregnancy and childbirth, and to identify and refer very low birth weight and/or sick babies, through routine home-visits by community health workers (CHWs), and by so doing reduce neonatal mortality.


Options:
A: Newborn survival (to 28 days) (July 2010 to June 2013)
B: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
C: Neonatal mortality rate (deaths within 28 days of birth)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cluster Randomised Trial to Evaluate the Impact of Routine Home Visits to Provide a Package of Essential Newborn Care Interventions in the Third Trimester of Pregnancy and the 1st Week of Life on Neonatal Mortality in Rural Ghana
Brief Summary: Introduction: Just under four million infants die each year before reaching one month of age; neonatal deaths now account for 38% of the 10.8 million deaths among children younger than 5 years of age. Tackling neonatal mortality is essential if the millennium development goal to reduce by 2015 overall child mortality by two-thirds from its levels in 1990 is to be achieved. Postnatal care for mothers and neonates in developing countries, particularly when deliveries occur at home, is either not available or is of poor quality. Trained community workers are considered by many to be pivotal to newborn care in the community, as they can act as catalysts for community actions and also be providers of care.Reductions in neonatal mortality have been slower in Sub-Saharan Africa than in any other region, and no evaluations of the effectiveness and feasibility of home visits in reducing neonatal mortality have been conducted.

Trial aim: To link with the Ghana Health Service to develop a feasible and sustainable intervention to improve newborn care practices and careseeking during pregnancy and childbirth, and to identify and refer very low birth weight and/or sick babies, through routine home-visits by community health workers (CHWs), and by so doing reduce neonatal mortality.


Options:
A: Post day 1 Neonatal mortality (birth to 28 days of age) in the communities receiving the intervention(cohort of infants born to women identified through pregnancy surveillance) (Over 30 Months); Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance (Over 30 Months); Post day 1 neonatal mortality (1 to 28 days of age) in the population of newborns who are more likely to have greater impact from the intervention i.e. those born at home and available in the study area within 7 days of birth (30 months); Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention (30 months); Infant mortality (birth to 365 days) in the communities receiving the intervention. (30 months)
B: Perinatal mortality (12 months)
C: Placental malaria (After delivery)
D: Neonatal mortality rate (deaths within 28 days of birth)

Answer: D