TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Start or STop Anticoagulants Randomised Trial (SoSTART) After Spontaneous Intracranial Haemorrhage
Brief Summary: Primary research question: For adults surviving spontaneous (non-traumatic) symptomatic intracranial haemorrhage with persistent/paroxysmal atrial fibrillation/flutter (AF), does starting full treatment dose oral anticoagulation (OAC) result in a beneficial net reduction of all serious vascular events compared with not starting OAC?

Trial design: Investigator-led, multicentre, randomised, open, assessor-masked, parallel group, clinical trial of investigational medicinal product (CTIMP) prescribing strategies. Investigators plan for a pilot phase, followed by a safety phase.


Options:
A: Fatal or non-fatal symptomatic ICH. (2 years)
B: The number of participants recruited per site per month (in the pilot phase of the trial) (1 year after trial initiation); Recurrent symptomatic spontaneous intracranial haemorrhage (in the safety phase of the trial) (1 year after randomisation)
C: Time to the first incident ischemic stroke event. (3 years); Time to the first recurrent intracerebral haemorrhage event. (3 years)
D: Number of patients who experience the combination of vascular death or non-fatal stroke (cerebral infarction, intracerebral haemorrhage, or subarachnoid haemorrhage) (Throughout the study. Patients will be followed up between 12 (minimum) and 72 (maximum) months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: "Escola em Ação": School Based Interventions of Incentive to the Practice Physical and Life Habits of Healthy Promotion
Brief Summary: Background: The health promotion actions carried out in the school environment have positive effects on reducing risk factors for chronic diseases in adolescents. Interdisciplinary strategies involving school and family to increase the level of physical activity among adolescents, inside and outside the school, are essential to encourage healthier lifestyles.

Aim: To determine whether a 24-weeks interdisciplinary intervention program promotes improvement in the level of physical activity, physical fitness, sleep quality, life satisfaction, eating habits and reduce the sedentary behavior of schoolchildren aged 10 to 13 years of public schools in the city of Presidente Prudente, São Paulo, Brazil.

The intervention: Includes training of teacher Physical Education in the principles of self-determination theory and ecological theory at practical applications for motivating adolescents in physical activities and sports. The students will be given information on the benefits of a physically active lifestyle and will be encouraged to participated the new opportunities for physical activity in their school and community. The program will offer physical activity strategies over the 24-weeks during class Physical Education, afternoon recess and active lesson breaks in theoretical classes. Nutritional guidelines and gardening experience will be developed to encourage healthy eating habits among schoolchildren and to reduce salt, oil and sugar in the preparation of school lunch.

Methods/design: The project, which being conducted as cluster randomized trial, is to evaluated whit in a mixed methods, including qualitative and quantitative approach will be used for the construction of the actions integrated to the school physical education curriculum and evaluation of the program by the participants and supporters. The RE-AIM evaluation metric (Reach, Effectiveness, Adoption, Implementation, and Maintenance) is used to guide the validation this program.


Options:
A: Change from baseline in weekly time in moderate-to-vigorous physical activity at six months (Baseline, end of intervention (6 months), 1 year after baseline); Change from baseline in weekly time in sedentary activity at six months (Baseline, end of intervention (6 months), 1 year after baseline)
B: Change in knowledge (Three months); Change in attitude (Three months); Change in practice (Three months)
C: Method of student transportation to school (Immediately pre- and post-intervention)
D: Inhibition (8 months intervention); Working memory (8 months intervention); Cognitive flexibility (8 months intervention); Aerobic fitness (8 months intervention); Physical activity (8 months intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Evaluation of a mHealth Platform for Diarrheal Disease Decision-support in Hospitals: a Cluster Randomized Controlled Trial
Brief Summary: The study hypothesis is that clinical decision-support on a smartphone for the management of diarrheal disease will improve the assessment of dehydration, reduce IV fluid usage, and increase guideline adherence for the use of zinc and antibiotics. To test this hypothesis we will conduct a cluster randomized controlled trial in the diarrhea wards of 10 hospitals in Bangladesh. A 6-week pre-intervention period will establish a baseline at all sites, and in the intervention, hospitals will be randomized to use a paper versus smartphone adaptation of the WHO guidelines by the admitting physician. Inclusion criteria are patients 2 months and older that have uncomplicated acute diarrheal disease; estimated enrollment is 7893 patients. The primary outcome measure is use of IV fluids. This project may have broad impact that will include opportunities to provide improved decision-support for the assessment of dehydration, decreased use intravenous fluids and more prudent use of antibiotics.


Options:
A: Contraception Use Self-efficacy Scale Score (Aim 1b) (Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)); Contraception Use Self-efficacy Scale Score (Aim 1c) (Baseline, 3 months, 6 months); Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b) (Baseline, 3 months, 6 months)
B: systolic blood pressure (change from baseline to 12-month of follow-up)
C: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)
D: Use of IV fluid (Intervention is 3 months per hospital)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
Brief Summary: This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.


Options:
A: Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis. (week 0); Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis. (week 0); Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. (week 0)
B: Retention in care with viral suppression (48 weeks after HIV testing)
C: Treatment time (Up to 8 weeks)
D: Time to TB treatment initiation (8 weeks follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
Brief Summary: This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.


Options:
A: Retention in care with viral suppression (48 weeks after HIV testing)
B: increase TB case detection (6 months)
C: Time to TB treatment initiation (8 weeks follow up)
D: Treatment time (Up to 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
Brief Summary: This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.


Options:
A: Treatment time (Up to 8 weeks)
B: increase TB case detection (6 months)
C: Retention in care with viral suppression (48 weeks after HIV testing)
D: Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection (Day 1); Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection (Day 1); Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection (Day 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
Brief Summary: This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.


Options:
A: Notification Rate Ratio (October 2012 (up to 2 years)); Costs Per Detected Case (October 2012 (up to 2 years))
B: Retention in care with viral suppression (48 weeks after HIV testing)
C: increase TB case detection (6 months)
D: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases (2 months after enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
Brief Summary: This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.


Options:
A: Retention in care with viral suppression (48 weeks after HIV testing)
B: Time to TB treatment initiation (8 weeks follow up)
C: Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis. (week 0); Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis. (week 0); Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. (week 0)
D: Tuberculosis diagnostic algorithm (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
Brief Summary: This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.


Options:
A: Retention in care with viral suppression (48 weeks after HIV testing)
B: Number of patients who complete tuberculosis treatment (6 months)
C: Treatment time (Up to 8 weeks)
D: All-cause Mortality (6 months post-HAART initiation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
Brief Summary: This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.


Options:
A: Treatment time (Up to 8 weeks)
B: Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis. (week 0); Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis. (week 0); Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. (week 0)
C: Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS. (Day 1); Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS. (Day 1); Diagnostic yield, with 95% confidence interval, of FujiLAM test among eMRS positive patients and AlereLAM, Smear and Ultra (sputum, urine) as comparators (on Day 1 specimens). (Day 1)
D: Retention in care with viral suppression (48 weeks after HIV testing)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy
Brief Summary: This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention of acute mountain sickness. These drugs have never been directly compared for efficacy. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California.


Options:
A: Acute mountain sickness score (At 3230m and 4,130m(Annapurna base camp))
B: Acute mountain sickness, cumulative incidence (day 3 at 3200 m)
C: Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom. (within 18 hours after ascent to altitude 3100m)
D: incidence of acute mountain sickness (2 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: High-Intensity Training Following Lung Transplantation: a Randomized Controlled Trial
Brief Summary: The HILT study is a prospective, single-blinded, randomized controlled trial comparing a high-intensity exercise training intervention with usual care among adult lung transplant recipients. Patients randomized to the training intervention arm will undergo individually tailored high-intensity exercise training (80-95% of maximum heart rate) three hours per week for 20 weeks. Training will be conducted at local fitness centers on a one-on-one basis.


Options:
A: Exercise Shuttle Test (metres completed)
B: Change in daily physical activity (Measured for 1 week pre-transplant, measured for 1 week at randomisation (1-2 months post-transplant), 1 week following the 3 month intervention, 1 week at 6 months post randomisation and 1 week at 12 months post-randomisation.)
C: Change in peak oxygen uptake (0-20 weeks)
D: HRQoL, exercise capacity (36 mts)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Community-based Health Intervention Trial to Increase Attendance to Cervical Cancer-screening Program Among Immigrants in Norway.
Brief Summary: Although health-related interventions should become increasingly diversity-sensitive, there will always be a need of adapting specific interventions to some immigrant populations. Adapting selected services to the individual cultural and religious background is necessary to reduce health inequalities and provide effective health care and is dependent on the active involvement of users. In this proposal the investigators present a community-based health intervention trial with two parallel interventions aimed at increasing participation of immigrant women to the existing cervical cancer-screening program. Through this study, the investigators will provide new practice-based knowledge and a firmer evidence base to improve health interventions that can contribute to equal health care and good health for all - including the immigrant population.

Based on identified barriers and factors that influence the interactions between immigrants and health care professionals for screening of cervical cancer in Norway, the investigators have develop two adapted interventions. One strategy will target immigrant women, and the other one will focus on general practitioners. Thus, this proposal will specifically contribute to the development of personalized health prevention interventions for the most common cancer-screening program in Norway, with a focus on immigrant's personal circumstances and health care needs.


Options:
A: Glycemic Control (12 months.)
B: The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production (2 years)
C: Mammogram receipt (1 week)
D: Participation in cervical cancer screening (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Knowledge Translation in Nutrition Through a Healthy Eating Blog: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to evaluate the effects of an evidence-based healthy eating blog on dietary behaviors of mothers


Options:
A: body mass index (three years)
B: Change in intake of the target vegetable (Change in intake of the target vegetable from Baseline to day 14)
C: 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)
D: Daily intakes of dairy products, vegetables and fruits measured by a validated web-based food frequency questionnaire (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Post-transplantation Diabetes Mellitus
Brief Summary: This is a single-center, prospective, controlled, double-blind, randomized study. A total of 50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (PTDM) will be included more than 1 year after transplantation and randomized 1:1 to empagliflozin (Jardiance®) 10 mg or placebo once daily for 24 weeks. Patients with estimated glomerular filtration rate below 30 mL/min will be excluded. Oral glucose tolerance test, 72h continuous glucose monitoring (iPro™2), measurement of arterial stiffness, body composition (including visceral fat), 24h blood pressure and 24h urinary glucose excretion will be performed at baseline and after 24 weeks in addition to standard safety measurements. Two safety visits will be performed at week 8 and 16. All concomitant medication, diet and exercise will be kept stable during the study period. The objective of the present study is to answer whether empagliflozin safely and effectively improves glucose metabolism together with weight loss in renal transplant recipients with PTDM.


Options:
A: Weighted mean glucose (24 weeks)
B: Concentration of glucagon during fasting glycemia and during hyperglycemic conditions measured in picomoles per liter (4 weeks)
C: Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years))
D: Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke (up to 5.2 years); Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. (up to 5.2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Partially-Blinded, Randomized, 24-Week, Parallel-Group, Non-Inferiority, Open-Label Active Controlled Study to Compare the Efficacy and Safety of QVM149 With a Free Triple Combination of Salmeterol/Fluticasone + Tiotropium in Patients With Uncontrolled Asthma
Brief Summary: The purpose of this trial was to demonstrate that the efficacy of two treatment arms of the fixed-dose combination product QVM149 was non-inferior to the efficacy of the free combination arm of salmeterol/ fluticasone+ tiotropium in uncontrolled moderate to severe asthmatic patients.

The planned duration of treatment in this study was 24 weeks, followed up by a 7-day follow-up period.


Options:
A: Peak expiratory flow (PEF) (28 days)
B: Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry. (12 weeks)
C: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24)
D: Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score (Baseline and Week 24)

Answer: D