TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT Testing the Effectiveness of an Early Obesity Prevention Program
Brief Summary: The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.

The proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial.

Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices


Options:
A: Maternal sensitivity (The mother-child relation will be videotaped and assessed during a home-visit by the health visitor after the intervention is finished when the child is around 9 months old.)
B: Reduction in the prevalence and degree of obesity at age 3 years (3 years); Improvement in infant diet composition (1-3 years); Improvement in infant lifestyle behaviors associated with increased risk of obesity. (1-3 years); Improvement in parent feeding knowledge, attitudes, styles and practices (1-3 years); Reduction in infant and child excess weight gain (1-3 years); Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention (2-5 years); Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention (2-5 years); Feasibility process measures: (2-5 years); Participant engagement (2-5 years); Participant satisfaction (2-5 years)
C: Breastfeeding Initiation (Three days postpartum); Positive parenting behavior (Parent Child Observation Guide) (4 months postpartum)
D: Exclusive breastfeeding (Six months post-birth); Maternal BMI (Six months post-birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT Testing the Effectiveness of an Early Obesity Prevention Program
Brief Summary: The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.

The proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial.

Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices


Options:
A: Change in percentage overweight (Baseline, Week 12 (post-intervention), Week 24)
B: Body mass index percentile (6 months)
C: Reduction in the prevalence and degree of obesity at age 3 years (3 years); Improvement in infant diet composition (1-3 years); Improvement in infant lifestyle behaviors associated with increased risk of obesity. (1-3 years); Improvement in parent feeding knowledge, attitudes, styles and practices (1-3 years); Reduction in infant and child excess weight gain (1-3 years); Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention (2-5 years); Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention (2-5 years); Feasibility process measures: (2-5 years); Participant engagement (2-5 years); Participant satisfaction (2-5 years)
D: For adults: body weight loss maintenance (6 Month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Title: Is a Family-based, Life Skills Focused Intervention Effective in Reducing Psychological Distress and Stigma and Improving Inter-personal Relations and Functioning Among Former LRA Abductees and Other War-affected Children in Their Community in Dungu, the Democratic Republic of Congo?
Brief Summary: The main research question of the study is whether a family-based, life-skills focused psychosocial intervention is effective in reducing psychological distress and stigma and improving inter-personal relations and functioning among war-affected children in the Democratic Republic of Congo.


Options:
A: Child development composite score (Change children's cognition, language and motor as composite score after one year intervention); Children's behavior and composite score (Change children's behaviour after one year intervention)
B: Medical students' empathy (3 months)
C: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
D: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Title: Is a Family-based, Life Skills Focused Intervention Effective in Reducing Psychological Distress and Stigma and Improving Inter-personal Relations and Functioning Among Former LRA Abductees and Other War-affected Children in Their Community in Dungu, the Democratic Republic of Congo?
Brief Summary: The main research question of the study is whether a family-based, life-skills focused psychosocial intervention is effective in reducing psychological distress and stigma and improving inter-personal relations and functioning among war-affected children in the Democratic Republic of Congo.


Options:
A: Change from baseline post traumatic stress symptoms at 6 months (baseline and 6 month follow up); Change from baseline depression symptoms at 6 months (baseline and 6 month follow up); Change from baseline hope at 6 months (baseline and 6 month follow up)
B: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
C: Patient Health Questionnaire (PHQ-9) (8 weeks); WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (8 weeks)
D: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Title: Is a Family-based, Life Skills Focused Intervention Effective in Reducing Psychological Distress and Stigma and Improving Inter-personal Relations and Functioning Among Former LRA Abductees and Other War-affected Children in Their Community in Dungu, the Democratic Republic of Congo?
Brief Summary: The main research question of the study is whether a family-based, life-skills focused psychosocial intervention is effective in reducing psychological distress and stigma and improving inter-personal relations and functioning among war-affected children in the Democratic Republic of Congo.


Options:
A: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
B: Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) (3 months, 6 months and 1 year after completion of treatment)
C: Change of depression symptom from baseline at 3 and 6 months (0-3-6 months); Change of anxiety symptom from baseline at 3 and 6 months (0-3-6 months); Change of chronic pain symptom from baseline at 3 and 6 months (0-3-6 months); Change of anger from baseline at 3 and 6 months (0-3-6 months); Change of PTSD symptom from baseline at 3 and 6 months (0-3-6 months)
D: Severity of Trauma. This will be the difference in group mean score of severity of depression based on a sum of ratings of various standard depression symptoms from the Hopkins Symptom Checklist and locally defined symptoms. (After 12 counseling , 4-5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Title: Is a Family-based, Life Skills Focused Intervention Effective in Reducing Psychological Distress and Stigma and Improving Inter-personal Relations and Functioning Among Former LRA Abductees and Other War-affected Children in Their Community in Dungu, the Democratic Republic of Congo?
Brief Summary: The main research question of the study is whether a family-based, life-skills focused psychosocial intervention is effective in reducing psychological distress and stigma and improving inter-personal relations and functioning among war-affected children in the Democratic Republic of Congo.


Options:
A: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
B: PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder (pre-treatment, 1 month post, 6 months follow up)
C: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)
D: Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources. (Immediately post-intervention and 6-months post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Title: Is a Family-based, Life Skills Focused Intervention Effective in Reducing Psychological Distress and Stigma and Improving Inter-personal Relations and Functioning Among Former LRA Abductees and Other War-affected Children in Their Community in Dungu, the Democratic Republic of Congo?
Brief Summary: The main research question of the study is whether a family-based, life-skills focused psychosocial intervention is effective in reducing psychological distress and stigma and improving inter-personal relations and functioning among war-affected children in the Democratic Republic of Congo.


Options:
A: Harvard Trauma Questionnaire (Baseline, 12 weeks, 3 months)
B: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
C: Change of depression symptom from baseline at 3 and 6 months (0-3-6 months); Change of anxiety symptom from baseline at 3 and 6 months (0-3-6 months); Change of chronic pain symptom from baseline at 3 and 6 months (0-3-6 months); Change of anger from baseline at 3 and 6 months (0-3-6 months); Change of PTSD symptom from baseline at 3 and 6 months (0-3-6 months)
D: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Title: Is a Family-based, Life Skills Focused Intervention Effective in Reducing Psychological Distress and Stigma and Improving Inter-personal Relations and Functioning Among Former LRA Abductees and Other War-affected Children in Their Community in Dungu, the Democratic Republic of Congo?
Brief Summary: The main research question of the study is whether a family-based, life-skills focused psychosocial intervention is effective in reducing psychological distress and stigma and improving inter-personal relations and functioning among war-affected children in the Democratic Republic of Congo.


Options:
A: Change on Beck Depression Inventory-II (Screening; baseline, 6-8 weeks after baseline and 4 months after baseline)
B: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
C: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
D: Timeline Followback alcohol use (percent drinking days) (longitudinal alcohol use from baseline (past 30 days) to 9 month post-intervention follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy: Determining the Balance Between Benefits and Risks
Brief Summary: Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.

Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy of the knee. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.


Options:
A: Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality (3-month period); Major Bleedings (3 months)
B: Aberrant Behavior Checklist (ABC) irritability score (Baseline and 3 months)
C: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
D: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy: Determining the Balance Between Benefits and Risks
Brief Summary: Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.

Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy of the knee. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.


Options:
A: Aberrant Behavior Checklist (ABC) irritability score (Baseline and 3 months)
B: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
C: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
D: Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality (3-month period); Major Bleedings (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy: Determining the Balance Between Benefits and Risks
Brief Summary: Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.

Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy of the knee. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.


Options:
A: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
B: Clinically important venous thromboembolism at 3 months
C: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
D: Primary outcome measure is deep vein trombosis as detected by venous duplex (subjects are assessed after 6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation: Determining the Balance Between Benefits and Risks
Brief Summary: Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.

Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.


Options:
A: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
B: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
C: Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality (3-month period); Major Bleedings (3 months)
D: Aberrant Behavior Checklist (ABC) irritability score (Baseline and 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation: Determining the Balance Between Benefits and Risks
Brief Summary: Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.

Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.


Options:
A: Aberrant Behavior Checklist (ABC) irritability score (Baseline and 3 months)
B: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
C: Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality (3-month period); Major Bleedings (3 months)
D: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)

Answer: B