TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers: a Randomized Controlled Multicenter Trial (DIVA)
Brief Summary: In this 7-month randomized controlled trial, children aged 1 to less than 6 years, with recurrent asthma attacks triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5 months during their usual clinic visit, and a daily supplement of vitamin D or a placebo. This study will test whether children in vitamin D group have less frequent and less severe asthma exacerbations compared with those receiving placebo.The study will also document the safety profile of this strategy.


Options:
A: Asthma Control Measured With Asthma Control Test (ACT) (6 months)
B: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)
C: Number of asthma exacerbations per child treated with rescue oral corticosteroids (7 months)
D: Mean Annual Rate of Respiratory Events (Up to 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers: a Randomized Controlled Multicenter Trial (DIVA)
Brief Summary: In this 7-month randomized controlled trial, children aged 1 to less than 6 years, with recurrent asthma attacks triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5 months during their usual clinic visit, and a daily supplement of vitamin D or a placebo. This study will test whether children in vitamin D group have less frequent and less severe asthma exacerbations compared with those receiving placebo.The study will also document the safety profile of this strategy.


Options:
A: Weight gain in children (2 Months)
B: Serum interleukin-6 (At trial entry and 7 days after daily vitamin D supplementation therapy); Serum tumor necrosis-alpha (At trial entry and 7 days after daily vitamin D supplementation therapy)
C: incidence of pneumonia (18 months)
D: Number of asthma exacerbations per child treated with rescue oral corticosteroids (7 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Case-Finding in Low and Middle Income Countries
Brief Summary: This study will test how well short questionnaires, with and without a simple breathing test called 'peak flow', can identify people with COPD compared to the gold-standard diagnostic test called spirometry. We will test this in 10,500 people from three low- and middle-income countries, namely Nepal, Peru and Uganda. We will also examine the feasibility of implementing our case-finding intervention at scale.


Options:
A: Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools (12 months)
B: Number of hospitalizations (2011)
C: Number of unscheduled hospital days (up to 12 months)
D: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring The Therapeutic Benefits Of Oral Protein Supplementation In Malnourished Dialysis Patients
Brief Summary: The dialysis population has a strikingly high incidence of mortality. The life expectancy of chronic dialysis patients is 20 years less than that of the general population. Approximately 50% of individuals with end stage renal disease (ESRD) die from a cardiovascular (CV) cause with mortality being 15 to 30 times higher than the age-adjusted CV mortality in the general population. There is also a steady increase of patients with diabetes and the older age groups coming into dialysis. The treatment of patients with ESRD aims at prolonging life, achieving good nutritional status and promoting the best possible functioning and quality of life (QOL). Several factors that are beyond adequacy of dialysis predict high mortality in ESRD patients. Associated co-morbidities and malnutrition factors are independently associated and the combined presence of both malnutrition and co-morbidities manifest the worst survival.Therefore this study investigates the efficacy of protein supplementation in improving health status and quality of life among peritoneal dialysis (PD) patients. This research will also generate basic data about significant health markers critical to the health status of PD patients.


Options:
A: Changes in beat-to-beat systolic blood pressure (Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks)
B: increase in serum albumin (6 months)
C: Change in serum albumin (16 weeks)
D: Serum albumin (Change from baseline serum albumin at 6 months of the study); Body mass index (BMI) (Change from BMI at 6 months of the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrating Mobile Phone-Based Intervention With Test and Treat Strategy to Improve Clinic Attendance for Antiretroviral Pills Pick Up Among HIV Positive Individuals in Nepal: A Randomized Controlled Trial
Brief Summary: Antiretroviral therapy (ART) has been a game changer in the context of HIV-epidemic. From 2005 to 2015, HIV-related deaths have fallen by 45% thanks to ART. However, ART's success heavily depends on HIV-positive individuals' high adherence to it. This includes clinic attendance for various purposes. It is necessary among HIV-positive individuals for their antiretroviral (ARV) pills pick up, monitoring of their treatment outcomes, and treatment of their opportunistic infections. Among them, ARV pills pick up is the major reason for the ART clinic attendance. Improving clinic attendance for pills pick up remains one of the key challenges to ART programs. The World Health Organization (WHO) recommends more than 90% on-time ARV pills pick up as per the early warning indicators of HIV-drug resistance. Among six Asian countries, none of the 1048 clinics under the study could meet the WHO target. Among HIV-positive individuals, clinic attendance for pills pick can be improved by using mobile phones. Those who receive mobile phone reminders are two times more likely to attend their clinics regularly than those who did not receive such reminders. Nepal belongs to a low-income country and is facing a similar problem, too. In 2015, approximately 39,000 people were estimated to be living with HIV and ART coverage was limited to only 31.5%. In the same year, only 32% of the HIV-positive individuals attended their clinics regularly for ARV pills pick up. Like other countries, one of the potential strategies is to use mobile phones effectively in Nepal. Mobile phones have been very widely used in Nepal. In 2016, Nepal had 27.9 million mobile phone users, against the population of 26.5 million. Under such a context, mobile phone reminders can be effective to improve clinic attendance among HIV-positive individuals. However, the effectiveness of such interventions barely remains examined by using a randomized controlled trial. This study evaluates the effectiveness of mobile phone reminder intervention on improving clinic attendance for ARV pills pick up and medication adherence among HIV-positive individuals on ART following the implementation of test and treat strategy in Nepal.


Options:
A: LARC uptake (at time of intervention (baseline (0 weeks))
B: Clinic attendance for pills pick up (six months.)
C: Adherence to cervical cancer screening (step1) (Up to 20 months)
D: Use of long acting and reversible contraceptive at 4 months (4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrating Mobile Phone-Based Intervention With Test and Treat Strategy to Improve Clinic Attendance for Antiretroviral Pills Pick Up Among HIV Positive Individuals in Nepal: A Randomized Controlled Trial
Brief Summary: Antiretroviral therapy (ART) has been a game changer in the context of HIV-epidemic. From 2005 to 2015, HIV-related deaths have fallen by 45% thanks to ART. However, ART's success heavily depends on HIV-positive individuals' high adherence to it. This includes clinic attendance for various purposes. It is necessary among HIV-positive individuals for their antiretroviral (ARV) pills pick up, monitoring of their treatment outcomes, and treatment of their opportunistic infections. Among them, ARV pills pick up is the major reason for the ART clinic attendance. Improving clinic attendance for pills pick up remains one of the key challenges to ART programs. The World Health Organization (WHO) recommends more than 90% on-time ARV pills pick up as per the early warning indicators of HIV-drug resistance. Among six Asian countries, none of the 1048 clinics under the study could meet the WHO target. Among HIV-positive individuals, clinic attendance for pills pick can be improved by using mobile phones. Those who receive mobile phone reminders are two times more likely to attend their clinics regularly than those who did not receive such reminders. Nepal belongs to a low-income country and is facing a similar problem, too. In 2015, approximately 39,000 people were estimated to be living with HIV and ART coverage was limited to only 31.5%. In the same year, only 32% of the HIV-positive individuals attended their clinics regularly for ARV pills pick up. Like other countries, one of the potential strategies is to use mobile phones effectively in Nepal. Mobile phones have been very widely used in Nepal. In 2016, Nepal had 27.9 million mobile phone users, against the population of 26.5 million. Under such a context, mobile phone reminders can be effective to improve clinic attendance among HIV-positive individuals. However, the effectiveness of such interventions barely remains examined by using a randomized controlled trial. This study evaluates the effectiveness of mobile phone reminder intervention on improving clinic attendance for ARV pills pick up and medication adherence among HIV-positive individuals on ART following the implementation of test and treat strategy in Nepal.


Options:
A: Plasma HIV-1 viral load (six months)
B: Clinic attendance for pills pick up (six months.)
C: Completion of vaccine primary series (12 months of age)
D: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrating Mobile Phone-Based Intervention With Test and Treat Strategy to Improve Clinic Attendance for Antiretroviral Pills Pick Up Among HIV Positive Individuals in Nepal: A Randomized Controlled Trial
Brief Summary: Antiretroviral therapy (ART) has been a game changer in the context of HIV-epidemic. From 2005 to 2015, HIV-related deaths have fallen by 45% thanks to ART. However, ART's success heavily depends on HIV-positive individuals' high adherence to it. This includes clinic attendance for various purposes. It is necessary among HIV-positive individuals for their antiretroviral (ARV) pills pick up, monitoring of their treatment outcomes, and treatment of their opportunistic infections. Among them, ARV pills pick up is the major reason for the ART clinic attendance. Improving clinic attendance for pills pick up remains one of the key challenges to ART programs. The World Health Organization (WHO) recommends more than 90% on-time ARV pills pick up as per the early warning indicators of HIV-drug resistance. Among six Asian countries, none of the 1048 clinics under the study could meet the WHO target. Among HIV-positive individuals, clinic attendance for pills pick can be improved by using mobile phones. Those who receive mobile phone reminders are two times more likely to attend their clinics regularly than those who did not receive such reminders. Nepal belongs to a low-income country and is facing a similar problem, too. In 2015, approximately 39,000 people were estimated to be living with HIV and ART coverage was limited to only 31.5%. In the same year, only 32% of the HIV-positive individuals attended their clinics regularly for ARV pills pick up. Like other countries, one of the potential strategies is to use mobile phones effectively in Nepal. Mobile phones have been very widely used in Nepal. In 2016, Nepal had 27.9 million mobile phone users, against the population of 26.5 million. Under such a context, mobile phone reminders can be effective to improve clinic attendance among HIV-positive individuals. However, the effectiveness of such interventions barely remains examined by using a randomized controlled trial. This study evaluates the effectiveness of mobile phone reminder intervention on improving clinic attendance for ARV pills pick up and medication adherence among HIV-positive individuals on ART following the implementation of test and treat strategy in Nepal.


Options:
A: the first aim is to assess our ability to enroll at least 70% (N=90) of eligible parents in a text messaging program (up to 1 year)
B: Clinic attendance for pills pick up (six months.)
C: Unprotected sex, no contraceptive (6-week post-baseline (in the past 6 weeks)); Unprotected sex, no highly effective contraceptive (6-week post-baseline (in the past 6 weeks))
D: Acceptability of at least one method of effective contraception (4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Motivational Interviewing and Neuroimaging With Adolescents
Brief Summary: This is a randomized controlled trial to examine the impact of two brief interventions on adolescent and young adult alcohol use behaviors and related brain response. The interventions being compared are motivational interviewing (MI) and brief adolescent mindfulness (BAM).


Options:
A: Alcohol-related Problems (assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported)
B: alcohol use (6 months); HIV risk taking (6 months)
C: Drinks per drinking day (6 months); Rate of effective contraception (6 months)
D: Alcohol Use Disorders Identification Test score (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: 12 Months Weight Loss Study Using Feedback Messages Delivered Via Smartphone
Brief Summary: The overall purpose of this randomized clinical trial is to examine the effect and efficacy of the individualized, real-time, smartphone-based feedback of diet and physical activity self-monitoring on subsequent weight-control behaviors, weight loss outcomes and sustainability of patient engagement. Participants will be randomized to one of 2 groups: (1) Self-Monitoring -similar to what many people do on their own, subjects will self-monitor diet, physical activity using Fitbit and weight using a Bluetooth-enabled scale, and (2) Self-Monitoring +Feedback-participants will self-monitor as described for the Self-Monitoring group but also will receive tailored Feedback messages. The Self-Monitoring +Feedback participants will receive up to 4 daily discrete pop-up Feedback messages on the participant's smartphone delivered at random times during waking hours and tailored to content of recorded entries in the subjects' smartphone-based diaries and a weekly summary Feedback message about the participant's weight.


Options:
A: Change in Weight (Baseline, 1 month, 3 months)
B: Change in weight (6 and 12 months)
C: Change in measure of Health-related quality of life from baseline to 6-months follow up. (6-months)
D: Change in Weight from Baseline to 6 Months (Baseline and 6 Months); Change in Weight from Baseline to 30 Months (Baseline and 30 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Two Doses of Parenteral Amoxicillin Plus Single Dose Gentamicin Compared to Four Doses of Parenteral Ampicillin Plus Single Dose Gentamicin in Managing Children Hospitalized With WHO Classified Severe Pneumonia: a RCT
Brief Summary: Burden: Pneumonia remains the leading infectious cause of death accounting for 920,000 children under five around the world. This means a loss of over 2,500 child lives every day, or over 100 every hour. Since 2000, the number of child deaths caused by pneumonia has decreased by 47 percent. The tremendous progress made is due in part to the rapid roll-out of vaccines, better nutrition, and improved care-seeking and treatment for symptoms. However, pneumonia hasn't declined as quickly as other diseases such as malaria (58%), HIV/AIDS (61%), and measles (85%).

Knowledge gap: The Lancet Series on Childhood Pneumonia and Diarrhea has reported that case management is one of the three most effective interventions to reduce pneumonia deaths in children. It is also noted that the cost-effectiveness of these interventions in the national health system needs urgent assessment. It was suggested to find out means to reduce hospital stay without compromising the quality of care.

Relevance: The main purpose of the study is to compare the efficacy of two doses of parenteral Amoxicillin plus single-dose Gentamicin compared to four doses of parenteral Ampicillin plus single-dose Gentamicin. After 72 hours of treatment injectable Amoxicillin or injection Ampicillin will be switched to or replaced by oral Amoxicillin and will be discharged with an advice to attend to Ambulatory Care Unit (ACU) to receive a once-daily dose of injection Gentamicin for a total of 5 days. It is anticipated that this modified therapy will reduce the hospitalization stay of children with severe pneumonia and would therefore be relevant in countries with the resource-poor settings. By reducing the hospitalization period, this therapy has the potentials to reduce hospital-acquired infection.

Hypothesis (if any): Rate of treatment failure with two doses of injectable Amoxicillin plus single-dose Gentamicin will be no more than that of four doses of injectable Ampicillin plus single-dose Gentamicin in the management of children between 2 months to 59 months hospitalized for WHO classified severe pneumonia.


Options:
A: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (7 to 14 days after the end of therapy (EOT))
B: Clinical Cure Rate at the End-of-treatment (EOT) Visit (End-of-treatment (Day 10 or Day 11))
C: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (7 to 14 days after the end-of-therapy (EOT))
D: Treatment failure (within 48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients
Brief Summary: In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.


Options:
A: Occurrence of a composite endpoint (90 days)
B: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
C: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)
D: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients
Brief Summary: In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)
C: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)
D: Occurrence of a composite endpoint (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients
Brief Summary: In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.


Options:
A: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)
B: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)
C: FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status (Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion)
D: Occurrence of a composite endpoint (90 days)

Answer: D