TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Systems Intervention to Promote Colorectal Cancer Screening/ Program for the Elimination of Cancer Disparities
Brief Summary: Colorectal cancer is the second leading cause of cancer death and one of the most commonly diagnosed malignancies. Screening is effective at reducing incidence and mortality from colorectal cancer. This study will evaluate the effectiveness of implementing systems-changes in community health centers that facilitate screening.


Options:
A: PROMIS Asthma Impact Scale (v1.0, SF8a) (Baseline and 6 months after index ED discharge); PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a) (Baseline and 6 months after index ED discharge)
B: Practice-level colon cancer screening rate (12-months post baseline)
C: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs
D: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
Brief Summary: The goal of this study is to determine whether increasing participation in cognitive, physical, and/or social activities prevents cognitive decline in older African Americans (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and older) will be randomized to Behavior Activation (BA) (a behavioral intervention that increases participation in daily activities) or Supportive Therapy (ST) (a person-centered psychotherapy that involves active listening and offering support focusing on participants' problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and better quality of life than ST-treated subjects at 24 months.


Options:
A: Montgomery Asberg Depression Scale (MADRS) (12 week outcome); WHO Disability Assessment Schedule (WHODAS)-II (12-week outcome)
B: Incidence of depression or anxiety disorders (15 months)
C: Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) (24 months)
D: Improvement in patient quality of life (baseline to 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
Brief Summary: The goal of this study is to determine whether increasing participation in cognitive, physical, and/or social activities prevents cognitive decline in older African Americans (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and older) will be randomized to Behavior Activation (BA) (a behavioral intervention that increases participation in daily activities) or Supportive Therapy (ST) (a person-centered psychotherapy that involves active listening and offering support focusing on participants' problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and better quality of life than ST-treated subjects at 24 months.


Options:
A: quality of life: RAND, GDS (pre and post treatment); caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP) (pre- and post intervention)
B: Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) (24 months)
C: Agitation (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period); Passivity (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
D: Hamilton Rating Scale for Depression (Measured at screening, weeks 1 through 12, and week 36)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Type 2 Diabetes Peer Counseling on Behavioral, Metabolic, and Health Outcomes Among Latinos
Brief Summary: The objectives of this study are:

* To develop a comprehensive culturally tailored model of diabetes management that integrates the work of community-based peer counselors and clinical specialists into a multi-disciplinary health care team serving the Latino community.
* To implement an intervention that provides education and support to Latino adults diagnosed with Type 2 diabetes in both clinical and home settings.
* To evaluate this intervention for its impact on program adherence, and improved outcomes sustained over time as reflected by metabolic, clinical, cognitive and behavioral measures.


Options:
A: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)
B: Total Number of Medications (Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC)
C: Hemoglobin A1c (Change in Baseline in HbA1c at 6 Months)
D: Primary composite endpoint combined with: - Percentage of all-cause mortality - Percentage of Unplanned hospital admission - Percentage of Emergency visits. - Percentage of Institutionalization (At 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Type 2 Diabetes Peer Counseling on Behavioral, Metabolic, and Health Outcomes Among Latinos
Brief Summary: The objectives of this study are:

* To develop a comprehensive culturally tailored model of diabetes management that integrates the work of community-based peer counselors and clinical specialists into a multi-disciplinary health care team serving the Latino community.
* To implement an intervention that provides education and support to Latino adults diagnosed with Type 2 diabetes in both clinical and home settings.
* To evaluate this intervention for its impact on program adherence, and improved outcomes sustained over time as reflected by metabolic, clinical, cognitive and behavioral measures.


Options:
A: changes in HbA1c (from baseline to 12 and 24 weeks); changes in systolic and diastolic blood pressure (from baseline to 8, 16, and 24 weeks)
B: Change in HgbA1c (Glycemic control) (baseline, six month, one year, two years and three years)
C: Change in Glycosylated Hemoglobin (Hba1c) (From date of randomization every 3 months, up to one year)
D: Hemoglobin A1c (Change in Baseline in HbA1c at 6 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study Two for Development of Novel Behavioral Intervention Mindfulness Training for Smokers
Brief Summary: The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The study design includes two randomized arms to compare matched intensive interventions and a third non-randomized option for participants who prefer not to enter an intensive intervention. It is expected that roughly 50% (120) will choose to be in the randomized intensive interventions and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either Mindfulness Training for Smokers(MTS) (n = 60) or Integrated Training for Smokers (ITS)(n=60). Both MTS and ITS are smoking cessation interventions that provide 8 classes over a 6-week period and 2 weeks of nicotine patches. MTS provides and training in mindfulness whereas ITS provides training in quit smoking strategies and access to the Freedom From Smoking Online Premium Program. Participants who choose to be in a non-intensive intervention (estimated from prior recruitment data at n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line and 2 weeks of nicotine patches.


Options:
A: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
B: Smoking Abstinence (24 weeks post quit day)
C: Point prevalence abstinence at 6 months (6 months after beginning treatment)
D: The primary outcome variables are mental distress (GHQ12, SCL5 and MBI), student stress (PMSS) and subsequent work stress, subjective wellbeing (SWB), empathy (JPSE), mindfulness (FFMS) (9 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress Reduction and Cardiovascular Disease Morbidity and Mortality
Brief Summary: This randomized controlled clinical trial tests the hypothesis that a selected stress reduction approach, the Transcendental Meditation program will reduce all-cause mortality, myocardial infarction and stroke in African American patients with coronary heart disease. Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure and psychosocial stress.


Options:
A: All-cause mortality (within 5 years of enrollment)
B: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)
C: nicotinic weaning (1year); weight loss at least 5% (1 year); waist reduction at least 4% (1 year); physical activity at least 30 minute per day (3h per week) (1 year)
D: time from ACS symptom onset to admission to emergency department (two years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress Reduction and Cardiovascular Disease Morbidity and Mortality
Brief Summary: This randomized controlled clinical trial tests the hypothesis that a selected stress reduction approach, the Transcendental Meditation program will reduce all-cause mortality, myocardial infarction and stroke in African American patients with coronary heart disease. Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure and psychosocial stress.


Options:
A: Clinician-rated posttraumatic stress level (3 months)
B: Change in Depression (difference between the intervention and the control group) (At baseline and 3 months later (after intervention)); Change in Anxiety (difference between the intervention and the control group) (At baseline and 3 months later (after intervention))
C: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
D: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress Reduction and Cardiovascular Disease Morbidity and Mortality
Brief Summary: This randomized controlled clinical trial tests the hypothesis that a selected stress reduction approach, the Transcendental Meditation program will reduce all-cause mortality, myocardial infarction and stroke in African American patients with coronary heart disease. Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure and psychosocial stress.


Options:
A: Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52. (baseline and after 12 months); Changes from baseline in self-rated Health related quality of Life (36 item); The SF 36 - item short-form health status survey at week 52 (baseline and after 12 mounth); Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52 (baseline and after 12 months)
B: Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale) (From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.)
C: Smoking Abstinence (End of Treatment (8 weeks))
D: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Early Nutrient Intake on Growth and Body Composition
Brief Summary: The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.


Options:
A: Mean weight gain (3 years); Mean weight gain (5 years)
B: Weight gain (1- 365 days)
C: Body weight measured at each study visit (12 months)
D: Change in weight (Baseline to 4 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study on a Nordic Lifestyle Intervention Trial Investigating the Effect of Vigorous Activity and Intake of Whole Grain Rye on Cancer Progression, Insulin Sensitivity and Inflammation Among Men With Early Stage Prostate Cancer.
Brief Summary: PURPOSE:

To evaluate the feasibility of a future Nordic intervention trial, including vigorous activity and a high intake of whole grain rye, among prostate cancer patients on active surveillance.

Additionally, to investigate effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among prostate cancer patients on active surveillance.


Options:
A: Feasibility of a planned Nordic life style intervention (Five years)
B: change in physical activity (baseline to 3 months); change in physical activity (3 mos to 6 months); change in physical activity (6 months to 12 months)
C: Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer. (3 months)
D: QoL: Physical Well-Being (FACT-L) (assessed after 12 weeks of enrolement); General Fatigue (MFI) (assessed after 12 weeks of enrolement)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigations on Improving Docosahexaenoic and Arachidonic Acid Content in Preterm Infant Formula
Brief Summary: The investigators examined the effect of different levels of docosahexaenoic aicd (a long chain polyunsaturated fatty acid) intake on the fatty acid composition of plasma and erythrocyte phospholipids and on the maturity of visually evoked potentials in preterm infants. As a secondary outcome the conversion of linoleic acid and alpha linolenic acid into their corresponding long chain polyunsaturated fatty acids was studied.

Preterm infants were randomized in a double-blind fashion to one of three formulas containing different amounts of docosahexaenoic acid during the first two weeks of postnatal life. A control group received human milk. Blood samples were collected at study entry and 14 and 28 days thereafter. Uniformly 13C-labeled linoleic acid and alpha linolenic acid were applied orally before blood sampling at day 28. At postconceptional ages 48 weeks and 56 weeks visually evoked potentials were recorded.


Options:
A: plasma phospholipid fatty acid composition (28 days after intervention start); visually evoked potentials (48 weeks and 56 weeks postconceptional age)
B: Sum of omega-3 fatty acid levels in membrane phospholipids of RBC (after 4 months of consumption)
C: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
D: Cognitive development

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality Versus Enhanced Care as Usual for Suicidal Soldiers
Brief Summary: This is a randomized controlled trial comparing the use of new clinical intervention (the "Collaborative Assessment and Management of Suicidality--CAMS") versus enhanced care as usual for suicidal Soldiers who are seen at outpatient mental health clinics at Ft. Stewart GA.


Options:
A: Parasuicidal behaviour (intermittent)
B: Deliberate Self-harm Inventory (DSHI; Gratz, 2001) and Lifetime Suicide Attempt Self-Injury interview (LSASI; formerly Lifetime Parasuicide Count, Linehan MM, Comtois KA, unpublished manuscript, 1996) (baseline; 10 weeks; 20 weeks; 3 month follow up)
C: Time to Suicide Attempt (Up to 18 months)
D: Scale for Suicidal Ideation (Baseline, post-treatment, 1, 3, 6, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevalence of Metabolic Syndrome and Effects of Adjunctive Metformin on Metabolic Profiles in Clozapine-treated Schizophrenic Patients
Brief Summary: Background: Several studies have suggested that clozapine has the greatest propensity of all available atypical antipsychotics to induce weight gain and metabolic dysregulation. So it is necessary to conduct some interventions to prevent or treat metabolic dysregulation induced by clozapine.

Metformin has been reported to achieve weight loss in several groups of patients characterized by insulin resistance. Several studies evaluated the effects of metformin on antipsychotics-induced weight gain and study period lasted from 8 to 16 weeks. Long-term metformin use had more robust effect on metabolic dysregulation and body weight in non-psychiatric field.

Goals: The study goals are two-fold. The first goal is to estimate the prevalence of metabolic dysregulation among clozapine-treated schizophrenic patients in Taiwan. The second goal is to assess the reversal effect of metformin on metabolic disturbance among clozapine-treated schizophrenic patients in a 24-week double-blind, placebo-control trial. The investigators will use metformin 1500 mg/d or placebo in the second phase trial.

Methods: This study will be divided into two phases. The first phase is to estimate the prevalence of metabolic disturbances among clozapine-treated patients. The second will be a randomized, double-blind, and placebo-controlled study of adjunctive metformin for non-DM clozapine-treated patients.

The clozapine dosage was maintained unchanged during the study period. The eligible patients will be randomly assigned to either metformin or identical placebo pills. Metformin will be titrated to 1500 mg/day in 4 weeks. Patients' blood pressure (BP), waist circumference, body weight, fasting plasma glucose (FPG), triglyceride (TG), high-density lipoprotein cholesterol (HDL), insulin, and leptin will be measured at 2, 4, 8, 16, and 24 weeks after the start of metformin.

In a 3-year period, the investigators estimate to recruit 150 clozapine-treated patients in the first phase and 75 fulfill the second phase criteria. The investigators estimate 60 patients complete the second phase intervention (staying in second phase at least 4 weeks).

From this study, the investigators would like to know the prevalence of metabolic dysregulation among clozapine-treated schizophrenic patients and to know the effect of metformin on metabolic profile among non-DM clozapine treated patients.


Options:
A: Time from randomization to recurrence of a mood event
B: Evaluate the main and interactional effects of risperidone and olanzapine on body mass index (BMI), other measures of obesity, and other health-related factors, including total cholesterol, lipid panels, blood glucose, glycohemoglobin, and prolactin (twelve months)
C: Percentage of Participants That Responded to Treatment (this outcome was assessed throughout the study.)
D: body weight change (24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevalence of Metabolic Syndrome and Effects of Adjunctive Metformin on Metabolic Profiles in Clozapine-treated Schizophrenic Patients
Brief Summary: Background: Several studies have suggested that clozapine has the greatest propensity of all available atypical antipsychotics to induce weight gain and metabolic dysregulation. So it is necessary to conduct some interventions to prevent or treat metabolic dysregulation induced by clozapine.

Metformin has been reported to achieve weight loss in several groups of patients characterized by insulin resistance. Several studies evaluated the effects of metformin on antipsychotics-induced weight gain and study period lasted from 8 to 16 weeks. Long-term metformin use had more robust effect on metabolic dysregulation and body weight in non-psychiatric field.

Goals: The study goals are two-fold. The first goal is to estimate the prevalence of metabolic dysregulation among clozapine-treated schizophrenic patients in Taiwan. The second goal is to assess the reversal effect of metformin on metabolic disturbance among clozapine-treated schizophrenic patients in a 24-week double-blind, placebo-control trial. The investigators will use metformin 1500 mg/d or placebo in the second phase trial.

Methods: This study will be divided into two phases. The first phase is to estimate the prevalence of metabolic disturbances among clozapine-treated patients. The second will be a randomized, double-blind, and placebo-controlled study of adjunctive metformin for non-DM clozapine-treated patients.

The clozapine dosage was maintained unchanged during the study period. The eligible patients will be randomly assigned to either metformin or identical placebo pills. Metformin will be titrated to 1500 mg/day in 4 weeks. Patients' blood pressure (BP), waist circumference, body weight, fasting plasma glucose (FPG), triglyceride (TG), high-density lipoprotein cholesterol (HDL), insulin, and leptin will be measured at 2, 4, 8, 16, and 24 weeks after the start of metformin.

In a 3-year period, the investigators estimate to recruit 150 clozapine-treated patients in the first phase and 75 fulfill the second phase criteria. The investigators estimate 60 patients complete the second phase intervention (staying in second phase at least 4 weeks).

From this study, the investigators would like to know the prevalence of metabolic dysregulation among clozapine-treated schizophrenic patients and to know the effect of metformin on metabolic profile among non-DM clozapine treated patients.


Options:
A: Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo (Measured at the last study visit)
B: Changes in body weight (baseline; week-4; week-8; week-12)
C: Change From Baseline to Endpoint in Weight (Baseline to endpoint (22 weeks))
D: body weight change (24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Shang Ring With Conventional Surgical Methods: A Randomized Controlled Trial
Brief Summary: This is a randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia).


Options:
A: Pain scores on the Visual Analog Scale (Within the first 48 hours after circumcision); Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Up to six weeks after surgery)
B: Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing (Up to 30 minutes)
C: HIV acquisition; safety of circumcision
D: The study's primary goal is to compare the PrePex™ circumcision procedure with one of the approved WHO methods of surgical circumcision. (9 weeks)

Answer: A