TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Pain on Behavioural Disturbances in Patients With Moderate and Severe Dementia. A Cluster Randomized Trial
Brief Summary: In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those with severe dementia. Since older persons with dementia have less communicative skills, suffer from more pain and exhibit more agitation, pain may be a contributing factor in these patients. More than 40% of patients with BPSD are treated with neuroleptics despite described side-effects. There is an urgent need to investigate the impact of individual pain management on BPSD in patients with dementia.

It was hypothesized that

* pain increase BPSD in patients with dementia
* individual pain treatment decrease BPSD in patients with dementia


Options:
A: Cohen-Mansfield Agitation Inventory - long form (CMAI) (CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.)
B: Change from Baseline in Pain at 3 months (3 months); Change from Baseline in Pain at 6 months (6 months post intervention)
C: Change in the Cornell Scale for Depression in Dementia (CSDD) (Week -2, week 0, week 6 and week 13)
D: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Pain on Behavioural Disturbances in Patients With Moderate and Severe Dementia. A Cluster Randomized Trial
Brief Summary: In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those with severe dementia. Since older persons with dementia have less communicative skills, suffer from more pain and exhibit more agitation, pain may be a contributing factor in these patients. More than 40% of patients with BPSD are treated with neuroleptics despite described side-effects. There is an urgent need to investigate the impact of individual pain management on BPSD in patients with dementia.

It was hypothesized that

* pain increase BPSD in patients with dementia
* individual pain treatment decrease BPSD in patients with dementia


Options:
A: Cohen-Mansfield Agitation Inventory - long form (CMAI) (CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.)
B: Cohen-Mansfield (2 weeks)
C: NeuroBehavior Rating Scale-- Agitation (9 weeks); Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC) (Baseline to 9 weeks)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Dietary Fructose on Glucose and Lipid Metabolism in Healthy Human Subjects
Brief Summary: The increasing intake of fructose has been associated with an increase in obesity among US children and adolescents, but its "dose dependent" effects on insulin sensitivity and lipid metabolism has not been studied in detail. Methods: 36 healthy male adult human subjects will be included in this study. They will be randomly allocated into a low, moderate or high fructose, a moderate or high glucose and a sucrose diet for 3 weeks. In randomized order and with 4 week wash out intervals each subject will receive all six different diets. Three day food records will be used to measure total fructose and glucose intake. During the low fructose diet subjects will be instructed to avoid nutrients containing fructose aiming at consumption of less than 1g fructose/d. During the moderate fructose diet subjects will receive 3x13.3g of fructose or glucose, respectively. High fructose diet subjects will receive either 3x26.7g/d of fructose, 3x 26.7g/d of glucose or 3x 26.7g/d of sucrose in the form of three daily soft drinks taken together with the three main meals.

75 g oral glucose tolerance testing will be performed and composite insulin sensitivity index will be calculated The presence of phosphorylated fructose metabolites in plasma will be measured by targeted LC-MS/MS. In addition, metabolite biomarkers in plasma will be screened by untargeted metabolite profiling using both LC-MS and GC-MS. In a subgroup of 10 subjects an euglycemic hyperinsulinemic clamp will be performed using \[6,6- 2H2\]glucose.

Thus, the lipogenic potential of fructose in humans will be compared with isocaloric amounts of glucose. Particularly, the question whether lipogenic effects are continuously dose dependent or whether there is a lipogenic shunting and if yes, at what level of ingested fructose will be addressed.


Options:
A: Weight loss (One year)
B: LDL size (baseline and after each of 6 interventions)
C: Lipid Analysis (June 2012); Body Weight Analysis (November 2011); Glycemic Control Analysis (June 2012); Blood Pressure (BP) Analysis (January 2012); Uric Acid Analysis (February 2012); "Catalytic" Fructose Across Cardiometabolic Endpoints Analysis (January 2012); Non-Alcoholic Fatty Liver (NAFL) Analysis (June 2012)
D: Glucose in mg/dl (12 weeks); Triglycerides in mg/dl (12 weeks); Insulin (12 weeks); Cholesterol in mg/dl (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Prevention Trial Substituting Brown Rice for White Rice to Lower Markers for Diabetes Risk
Brief Summary: The specific aim of this study is to determine the effects of substituting brown for white rice on the treatment of metabolic syndrome (MetS).


Options:
A: Body Composition (Week 6 and 12 - End of diet period 1 and 2)
B: fasting glucose (16 weeks)
C: Weight Loss
D: Changes in glucose metabolism, changes in transcriptomic and metabolomic profiles (By 2010)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis
Brief Summary: Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a "routine" operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis.

The aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.


Options:
A: The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis (Up to 10 years)
B: Negative Appendectomy Rate (1 week after surgery)
C: Proportion of negative appendectomies (During the hospital admission)
D: sensitivity of IV contrast alone for a computed tomography scan for the diagnosis of appendicitis in the adult Emergency Department patient. (immediate reading + blinded reading within 48 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis
Brief Summary: Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a "routine" operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis.

The aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.


Options:
A: rate of intra abdominal infections in both therapeutic strategies (30 days)
B: Negative Appendectomy (1 week after surgery)
C: The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis (Up to 10 years)
D: Negative Appendectomy Rate (1 week after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Dynamic Humeral Centering in Impingement Syndrome: a Randomized Clinical Trial
Brief Summary: The purpose of this study is to determine wether dynamic humeral centering is effective in patients with impingement syndrome of the shoulder


Options:
A: Shoulder Pain and Disability Index (SPADI) (Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months)
B: Shoulder Pain and Disability Index (Baseline and 11 weeks); Participant perceived global rating of change post treatment (11 weeks)
C: Constant total score as a mean and by category (at 3 months)
D: Indicators of quality of life (WORC - Western Ontario Rotator Cuff The Index) (This scale is applied one day before and one day after the application of physical therapy intervention programs)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Newborn Survival in Rural Southern Tanzania: a Study to Evaluate the Impact and Cost of a Scaleable Package of Interventions at Community Level With Health System Strengthening
Brief Summary: This study will develop, implement and evaluate the effectiveness and cost of interventions at community level (focussed on a community-based health worker) and of health system strengthening on newborn survival in rural southern Tanzania.

Objectives

1. To develop and document a community-based package for improved newborn care, focussed around interpersonal communication through home visits in pregnancy and the early neonatal period .
2. To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
3. To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
4. To monitor understanding of, and attitudes related to, neonatal care and survival from both health provider and community perspectives in areas with and without the interventions.
5. To measure incremental costs and cost savings to the health sector and society associated with the interventions, and to predict the cost of integrating the programme into routine health service provision and of scaling-up
6. To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
7. To estimate the effect of the interventions on newborn survival and household behaviours related to newborn health.

Study design \& methods. The interventions will be implemented in parts of Lindi and Mtwara regions. The health system quality improvement package will be implemented throughout the area and evaluated using a before-after comparison. The community intervention will be implemented initially in a randomly-chosen half of all wards (a ward is an administrative sub-area of a district). Implementation will be led by existing front-line health staff. Evaluation will include a health facility survey and a household survey to assess contacts with the agents of change, key behaviours and newborn survival in the community.


Options:
A: Exclusive breastfeeding (6 months postpartum)
B: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)
C: Newborn survival (to 28 days) (July 2010 to June 2013)
D: proportion of patients with breastfeeding completed at 6 months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Newborn Survival in Rural Southern Tanzania: a Study to Evaluate the Impact and Cost of a Scaleable Package of Interventions at Community Level With Health System Strengthening
Brief Summary: This study will develop, implement and evaluate the effectiveness and cost of interventions at community level (focussed on a community-based health worker) and of health system strengthening on newborn survival in rural southern Tanzania.

Objectives

1. To develop and document a community-based package for improved newborn care, focussed around interpersonal communication through home visits in pregnancy and the early neonatal period .
2. To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
3. To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
4. To monitor understanding of, and attitudes related to, neonatal care and survival from both health provider and community perspectives in areas with and without the interventions.
5. To measure incremental costs and cost savings to the health sector and society associated with the interventions, and to predict the cost of integrating the programme into routine health service provision and of scaling-up
6. To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
7. To estimate the effect of the interventions on newborn survival and household behaviours related to newborn health.

Study design \& methods. The interventions will be implemented in parts of Lindi and Mtwara regions. The health system quality improvement package will be implemented throughout the area and evaluated using a before-after comparison. The community intervention will be implemented initially in a randomly-chosen half of all wards (a ward is an administrative sub-area of a district). Implementation will be led by existing front-line health staff. Evaluation will include a health facility survey and a household survey to assess contacts with the agents of change, key behaviours and newborn survival in the community.


Options:
A: Short-term Exclusive Breastfeeding (24-hour recall) (Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week); Long-term Exclusive Breastfeeding (24-hour recall) (Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week)
B: Neonatal mortality rate
C: Newborn survival (to 28 days) (July 2010 to June 2013)
D: Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention (through study completion, an average of 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Newborn Survival in Rural Southern Tanzania: a Study to Evaluate the Impact and Cost of a Scaleable Package of Interventions at Community Level With Health System Strengthening
Brief Summary: This study will develop, implement and evaluate the effectiveness and cost of interventions at community level (focussed on a community-based health worker) and of health system strengthening on newborn survival in rural southern Tanzania.

Objectives

1. To develop and document a community-based package for improved newborn care, focussed around interpersonal communication through home visits in pregnancy and the early neonatal period .
2. To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
3. To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
4. To monitor understanding of, and attitudes related to, neonatal care and survival from both health provider and community perspectives in areas with and without the interventions.
5. To measure incremental costs and cost savings to the health sector and society associated with the interventions, and to predict the cost of integrating the programme into routine health service provision and of scaling-up
6. To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
7. To estimate the effect of the interventions on newborn survival and household behaviours related to newborn health.

Study design \& methods. The interventions will be implemented in parts of Lindi and Mtwara regions. The health system quality improvement package will be implemented throughout the area and evaluated using a before-after comparison. The community intervention will be implemented initially in a randomly-chosen half of all wards (a ward is an administrative sub-area of a district). Implementation will be led by existing front-line health staff. Evaluation will include a health facility survey and a household survey to assess contacts with the agents of change, key behaviours and newborn survival in the community.


Options:
A: delayed bathing of baby (24 months)
B: Newborn survival (to 28 days) (July 2010 to June 2013)
C: Treatment failure (within 7 days of enrolment)
D: Reduction in perinatal and neonatal mortality (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Newborn Survival in Rural Southern Tanzania: a Study to Evaluate the Impact and Cost of a Scaleable Package of Interventions at Community Level With Health System Strengthening
Brief Summary: This study will develop, implement and evaluate the effectiveness and cost of interventions at community level (focussed on a community-based health worker) and of health system strengthening on newborn survival in rural southern Tanzania.

Objectives

1. To develop and document a community-based package for improved newborn care, focussed around interpersonal communication through home visits in pregnancy and the early neonatal period .
2. To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
3. To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
4. To monitor understanding of, and attitudes related to, neonatal care and survival from both health provider and community perspectives in areas with and without the interventions.
5. To measure incremental costs and cost savings to the health sector and society associated with the interventions, and to predict the cost of integrating the programme into routine health service provision and of scaling-up
6. To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
7. To estimate the effect of the interventions on newborn survival and household behaviours related to newborn health.

Study design \& methods. The interventions will be implemented in parts of Lindi and Mtwara regions. The health system quality improvement package will be implemented throughout the area and evaluated using a before-after comparison. The community intervention will be implemented initially in a randomly-chosen half of all wards (a ward is an administrative sub-area of a district). Implementation will be led by existing front-line health staff. Evaluation will include a health facility survey and a household survey to assess contacts with the agents of change, key behaviours and newborn survival in the community.


Options:
A: Newborn survival (to 28 days) (July 2010 to June 2013)
B: Proportion of infants born to HIV-infected mothers who have acquired HIV (During the first 2 years of life); Proportion of HIV-exposed infants tested for HIV (During the first 2 years of life); Proportion of pregnant women making at least four antenatal clinic visits (Between the first week of gestation and delivery); Proportion of pregnant women delivering at a healthcare facility (At delivery); Proportion of HIV-positive women receiving PMTCT (Between the first antenatal care visit and 1 week after stopping breastfeeding)
C: N/A
D: increase the proportion of institutional deliveries in intervention vs. control clusters (Up to 15 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Newborn Survival in Rural Southern Tanzania: a Study to Evaluate the Impact and Cost of a Scaleable Package of Interventions at Community Level With Health System Strengthening
Brief Summary: This study will develop, implement and evaluate the effectiveness and cost of interventions at community level (focussed on a community-based health worker) and of health system strengthening on newborn survival in rural southern Tanzania.

Objectives

1. To develop and document a community-based package for improved newborn care, focussed around interpersonal communication through home visits in pregnancy and the early neonatal period .
2. To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
3. To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
4. To monitor understanding of, and attitudes related to, neonatal care and survival from both health provider and community perspectives in areas with and without the interventions.
5. To measure incremental costs and cost savings to the health sector and society associated with the interventions, and to predict the cost of integrating the programme into routine health service provision and of scaling-up
6. To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
7. To estimate the effect of the interventions on newborn survival and household behaviours related to newborn health.

Study design \& methods. The interventions will be implemented in parts of Lindi and Mtwara regions. The health system quality improvement package will be implemented throughout the area and evaluated using a before-after comparison. The community intervention will be implemented initially in a randomly-chosen half of all wards (a ward is an administrative sub-area of a district). Implementation will be led by existing front-line health staff. Evaluation will include a health facility survey and a household survey to assess contacts with the agents of change, key behaviours and newborn survival in the community.


Options:
A: Newborn survival (to 28 days) (July 2010 to June 2013)
B: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
C: Breastfeeding at 3 months and at 6 months (3 months and six months)
D: Exclusive breastfeeding (6 months postpartum)

Answer: A