TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Empowering Primary Care Providers and Patients to Improve Chronic Disease Outcomes: The EMPOWER Participatory Action Research (EMPOWER - PAR)
Brief Summary: BACKGROUND

Chronic disease management (CDM) presents enormous challenges to the primary care workforce due to the rising epidemic of cardiovascular risk factors. The Chronic Care Model (CCM) was proven effective in improving chronic disease outcomes in developed countries. Evidence that this model works in developing countries is still scarce. Therefore, the aim of this study is to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted CDM strategies based on the CCM) in managing type 2 diabetes mellitus (T2DM) and hypertension (HPT), using readily available resources in the Malaysian public primary care setting.

METHODS

This is a pragmatic cluster randomised controlled trial - participatory action research which is currently being conducted in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics are randomly selected to provide the EMPOWER-PAR intervention for 1 year, while the other 5 clinics continued with usual care. Each clinic recruits consecutive T2DM and HPT patients who fulfil the inclusion and exclusion criteria over a 2-week period.

The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary CDM Team; and training the team to utilise the Global CV Risks Self-Management Booklet to support patient care and reinforcing them to utilise relevant clinical practice guidelines to aid management and prescribing.

For T2DM, primary outcome is the change in the proportion of patients achieving target HbA1c of \<6.5%. For HPT without T2DM, primary outcome is the change in the proportion of patients achieving target blood pressure of \<140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients' assessment of their chronic disease care, providers' perception, attitude and perceived barriers in delivering the care and cost-effectiveness of the intervention are also evaluated.

CONCLUSION

Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the CCM in resource constraint public primary care setting. It is hoped that the evidence will instigate the much needed primary care system change in Malaysia.


Options:
A: Patient Activation Measure (PAM) (Every 3 months during the 12-month trial)
B: Change in the proportion of patients achieving glycaemic and BP control (1 year)
C: Hemoglobin A1c Levels (5 years); Blood Pressure Levels (5 years); Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol (5 years)
D: Change in Hemoglobin A1c (3 months, 6 months, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication
Brief Summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.


Options:
A: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)
B: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose)
C: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) (Weeks 16 and 32)
D: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 48.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication
Brief Summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.


Options:
A: Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) (Day 92)
B: Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period (Up to Week 32)
C: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)
D: Annualized Rate of Asthma Exacerbations Over the Treatment Period (up to Week 24) (Baseline (Week 0) up to Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication
Brief Summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.


Options:
A: adenosine, PC20, forced expiratory volume in one second (FEV1)
B: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)
C: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set (Baseline (Day 1), Week 16)
D: Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) (Day 92)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Double and Triple Low Combination of Mean Arterial Pressure, and Either End-tidal Anesthetic Concentration or Bispectral Index.
Brief Summary: The objective of this study is to use a decision-support system combined with an electronic anesthesia record to detect double low clinical conditions (Mean Arterial Pressure (MAP) \< 75 mmHg, and Bispectral Index (BIS) \< 45) and generate alerts suggesting hemodynamic support. Specifically, the project will test the hypothesis that providing Double Low alerts reduces 90-day mortality. Secondary outcomes will be the fraction of alerts that generate early clinician responses, subsequent changes in MAP and hospital length of stay.


Options:
A: Symptomatic venous thromboembolic events and severe haemorrhage (3 months)
B: Change in rate of potentially inappropriate prescribing (Baseline, 8 weeks, 16 weeks)
C: rate of agreement between the diagnostic criteria applied in daily practice and those validated in the scientific literature
D: Mortality (at 90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma
Brief Summary: Severe traumatized patients (ISS \> 15) admitted to emergency department (ED) University Hospital Innsbruck with obvious bleeding and/or who are at risk for significant hemorrhage will be screened by rotational thrombelastometry (ROTEM) assays during ED treatment and subsequent surgical/radiological interventions for having coagulopathy (T0). If a patient meets the inclusion criteria (T1) and is recruited for the study, a first study related blood sample (40mL) will be drawn, and data collected. Subsequently, 100 patients will be randomized to receive Fibrinogen concentrate and/or Prothrombin complex concentrate and/or FXIII concentrate for reversal of coagulopathy, while the other 100 patients will receive fresh frozen plasma (FFP),respectively.

Treatment failure will be registered if bleeding persists and ROTEM parameters do not improve after two times dosages of study drug. In these cases haemostatic rescue therapy will be administered. CFC (fibrinogen concentrate and/or PCC, and/or FXIII concentrate) will be administered to patients randomized to receive FFP and FFP will be administered to patients of the CFC group.

In cases unresponsive to comprehensive treatment or normal ROTEM combined with diffuse bleeding, other haemostatic medications can be administered (e.g rFVIIa, DDAVP, VWF/FVIII concentrate) as judged by the anesthetist in charge. The need and type of any rescue therapy will be documented and a ROTEM will be performed thereafter.

At admission to ICU (T0 ICU), 24h (T24 ICU) and 48h(T48 ICU) thereafter further study related blood samples are drawn (40mL each).

The indications for transfusion of red blood cells or platelets, administration of antifibrinolytics, treatment of acidosis, hypothermia, hypocalcemia and volume replacement are similar for both groups and treatment is performed according to clinical routine.

Besides coagulation management during ED treatment until 24h on ICU, patient's care is not influenced by the study and follows clinical routine.


Options:
A: Multiple Organ Failure (MOF) (Variable until 24h on ICU at the end of the IMP-administration)
B: Total units of allogeneic blood products (Up to 24 hours after investigational medicinal product (IMP) administration)
C: Avoidance of allogeneic blood products transfusion (30 days)
D: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma
Brief Summary: Severe traumatized patients (ISS \> 15) admitted to emergency department (ED) University Hospital Innsbruck with obvious bleeding and/or who are at risk for significant hemorrhage will be screened by rotational thrombelastometry (ROTEM) assays during ED treatment and subsequent surgical/radiological interventions for having coagulopathy (T0). If a patient meets the inclusion criteria (T1) and is recruited for the study, a first study related blood sample (40mL) will be drawn, and data collected. Subsequently, 100 patients will be randomized to receive Fibrinogen concentrate and/or Prothrombin complex concentrate and/or FXIII concentrate for reversal of coagulopathy, while the other 100 patients will receive fresh frozen plasma (FFP),respectively.

Treatment failure will be registered if bleeding persists and ROTEM parameters do not improve after two times dosages of study drug. In these cases haemostatic rescue therapy will be administered. CFC (fibrinogen concentrate and/or PCC, and/or FXIII concentrate) will be administered to patients randomized to receive FFP and FFP will be administered to patients of the CFC group.

In cases unresponsive to comprehensive treatment or normal ROTEM combined with diffuse bleeding, other haemostatic medications can be administered (e.g rFVIIa, DDAVP, VWF/FVIII concentrate) as judged by the anesthetist in charge. The need and type of any rescue therapy will be documented and a ROTEM will be performed thereafter.

At admission to ICU (T0 ICU), 24h (T24 ICU) and 48h(T48 ICU) thereafter further study related blood samples are drawn (40mL each).

The indications for transfusion of red blood cells or platelets, administration of antifibrinolytics, treatment of acidosis, hypothermia, hypocalcemia and volume replacement are similar for both groups and treatment is performed according to clinical routine.

Besides coagulation management during ED treatment until 24h on ICU, patient's care is not influenced by the study and follows clinical routine.


Options:
A: Multiple Organ Failure (MOF) (Variable until 24h on ICU at the end of the IMP-administration)
B: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
C: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. (From administration of Haemocomplettan® P until 24 hours later)
D: Incidense of transfusion with allogenic blood products (During hospital stay or until 6 weeks postintervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Control Trial of Sputum Induction, and New and Emerging Technologies in a High HIV Prevalence Primary Care Setting
Brief Summary: This study will investigate the benefit of using Sputum induction for TB diagnosis in a primary care clinic for adult TB suspects that are either unable to produce a sputum sample (sputum scarce) or on initial diagnostic work-up have 2 negative sputum smear samples (WHO standard for frontline TB diagnosis). The investigators hypothesize that acquiring an induced sputum sample for smear microscopy and liquid TB culture will decrease time-to-diagnosis and time-to-treatment initiation in smear negative/sputum scarce TB patients in a primary care clinic in a resource-limited high TB HIV prevalent setting.


Options:
A: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
B: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)
C: Time-to-treatment initiation (Up to 48 days after enrollment)
D: Sensitivity and specificity (10 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis
Brief Summary: Ulcerative colitis is a condition that mainly affects young adults where the lining of the bowel is inflamed causing bloody diarrhea. The cause of ulcerative colitis is unknown and treatments remain imperfect with no cure for the disease. Initial success has been shown with a highly novel treatment where patients with active ulcerative colitis receive a fecal enema to try and replace their stool containing bacteria that may be driving their disease with that from a healthy donor. To assess if this works by comparing how well it treats the disease compared to a placebo enema.


Options:
A: diversity and steady state of the stool (6 months)
B: Clinical Response (4 weeks following GMT Treatment)
C: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
D: The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks (Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis
Brief Summary: Ulcerative colitis is a condition that mainly affects young adults where the lining of the bowel is inflamed causing bloody diarrhea. The cause of ulcerative colitis is unknown and treatments remain imperfect with no cure for the disease. Initial success has been shown with a highly novel treatment where patients with active ulcerative colitis receive a fecal enema to try and replace their stool containing bacteria that may be driving their disease with that from a healthy donor. To assess if this works by comparing how well it treats the disease compared to a placebo enema.


Options:
A: The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks (Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.)
B: Asses Endoscopic Stages of the Colon Pre/Post FMT (2 years); Asses Biologic Inflammatory Markers (2 years); Review and Track Patient reported Outcomes via Validated Questionnaires (2 Years)
C: Clinical Cure (8 weeks)
D: FT success defined by : Sorensen's index [receiver 6 weeks after FT vs donor] > Sorensen's index [receiver 6 weeks after FT vs receiver before FT]) with Sorensen's index [receiver 6 weeks after FT vs donor] ≥ 0.6. (6 weeks after FT)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Excessive Gestational Weight Gain in Obese Women
Brief Summary: The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.


Options:
A: Excessive weight gain during pregnancy (2007-2023)
B: Gestational weight gain (4 years)
C: Weight Gain Per Week of Observation (13 weeks gestation, 35 weeks gestation)
D: Gestational Weight Gain (GWG) (14-37 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Alcohol Intervention for School-to-Work Transitions
Brief Summary: This is a 2-year research project to test the efficacy of brief motivational intervention for reducing heavy alcohol use in young adults transitioning out of high school. Participation occurs within 3 months prior to graduation or within 1 year following graduation or dropout from high school. Heavy drinkers ages 17-20 will be randomly assigned to receive one session of BMI or one session of relaxation training. All participants complete identical assessments at baseline and immediately post-intervention (during session 1). Participants also complete in-person 6-week and 3-month follow up assessments to evaluate intervention effects. Study aims involve: a) testing the comparative efficacy of BMI; b) identifying moderators (person-level predictors) of intervention response; and c) identifying mediators (mechanisms) of intervention effects, that is, how BMI exerts its effect on outcomes.


Options:
A: Timeline Follow Back Assessing Number of Standard Drinks (3 months)
B: Compare the NCMIT and SCMT programs among homeless young gay and bisexual stimulant using men with respect to completion of a HBV vaccination series administered in three doses over a four-month period. (5 years)
C: Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare") (1 month)
D: Discontinuation of consumption of prescription drugs (one year); Reduction of consumption of prescription drugs (one year); Utilization of formal help (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinic and Home Family Based Behavioral Treatment for Obese Preschoolers
Brief Summary: This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic and home family behavioral intervention (LAUNCH) against 1) motivational interviewing (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the criteria for obesity (\>95th percentile for body mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary end-point will be change in BMI z-score at the end of treatment. The investigators will also assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in factors thought to be mechanisms for change in weight (food intake and activity level), changes in the obesiogenic environment (parent weight, food intake and activity, and changes in the home food environment) and factors that could be negatively impacted (parent and child eating and feeding interactions).


Options:
A: Change in BMIz score (Baseline to 6 months)
B: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
C: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
D: Infant weight for height (One year after study entry)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinic and Home Family Based Behavioral Treatment for Obese Preschoolers
Brief Summary: This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic and home family behavioral intervention (LAUNCH) against 1) motivational interviewing (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the criteria for obesity (\>95th percentile for body mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary end-point will be change in BMI z-score at the end of treatment. The investigators will also assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in factors thought to be mechanisms for change in weight (food intake and activity level), changes in the obesiogenic environment (parent weight, food intake and activity, and changes in the home food environment) and factors that could be negatively impacted (parent and child eating and feeding interactions).


Options:
A: Change in BMIz score (Baseline to 6 months)
B: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)
C: child nutritional status (Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo)
D: Provision of flesh-food or vitamin A-rich food (Change from baseline to 5 months)

Answer: A