TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Novel Approach to Improving Lactation Support Using Mobile Health Technology
Brief Summary: This is a randomized trial of use of a mobile health tool (EpxBreastfeeding) aimed at improving breastfeeding adherence and duration among recent mothers who self identify as motivated to breastfeed. As a result of text communication and expedited coaching through common breastfeeding challenges, the investigators expect more mothers in the study arm will continue breastfeeding through the first 6 months after giving birth.


Options:
A: Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) (3 months); Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) (3 months); Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) (12 months); Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) (12 months); Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) (12 months); Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) (12 months)
B: Improvement in the recall of LMP date among enrolled participants in the intervention arms compared to control arm (12 months after enrollment); Increased accuracy of LMP-based gestational age measurement, as compared to USG (12 months after enrollment)
C: Exclusive breastfeeding duration (Six months)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Psycho-educational Intervention for Symptom Cluster Management Among Cancer Patients Undergoing Chemotherapy in Vietnam
Brief Summary: The purpose of this study is to develop, implement and undertake a preliminary evaluation of a psychoeducational intervention for managing a cancer-related symptom cluster including pain, fatigue and sleep disturbance experienced by Vietnamese cancer patients.


Options:
A: average and worst pain as reported daily by patients on a scale from 0 (no pain) to 10 (worst imaginable pain) (measured daily for 10 weeks and in week 14 and 22)
B: Symptom cluster (4 weeks); Fatigue (4 weeks); Pain (4 weeks); Sleep disturbance (4 weeks)
C: Change in Patient Health Questionnaire-8 (baseline, 2 and 6 weeks post-intervention); Change in Generalized Anxiety Disorder 7-item scale (baseline, 2 and 6 weeks post-intervention)
D: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Telemedicine on Metabolic Control in the Care of Diabetes Mellitus Type 1 Patients in Multiple Doses of Insulin Treatment in Andalusian Community
Brief Summary: To assess the effect of a 6-month telemedicine program (DiabeTIC) in patients with type 1 diabetes mellitus (DM1) and regular metabolic control (HbA1c \<8%) in multi-dose insulin treatment (MDI) measured HbA1c vs. conventional medical care.


Options:
A: Changes in HbA1c (Baseline, 16 weeks, 32 weeks, 6 months after intervention)
B: Mortality (From diabetes diagnosis until median14 year after study start); Diabetic retinopathy (at 6 year and 14 year after study start); Urinary albumin concentration (at 6 year and 14 year after study start); Myocardial infarction (From diabetes diagnosis until median14 year after study start); Stroke (From diabetes diagnosis until median14 year after study start)
C: HbA1c (6 months)
D: Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack (Day 1); Diagnosed with CVD: Myocardial infarction, stable coronary artery disease (SCAD) also referred as angina (pectoris), other ischaemic heart disease and/or past revascularisation procedures (Day 1); Diagnosed with symptomatic heart failure: New York Heart Association Functional Classification (NYHA) (group IIIV) and/or left ventricular ejection fraction (LVEF) greater than or equal to 50 percent, LVEF 40-49 percent and LVEF less than 40 percent) (Day 1); Diagnosed with asymptomatic heart failure (Day 1); Hospitalisation for heart failure (Day 1); Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation (Day 1); Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease (Day 1); Diagnosed with peripheral artery disease: Asymptomatic peripheral arterial disease (PAD) defined as Low Ankle-Brachial Index (less than 0.90) or pulse abolition, claudication, limb ischemia and/or non-traumatic amputation (Day 1); Diagnosed with carotid artery disease (Day 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Motivational Interviewing to Address Reluctance and Ambivalence in Palliative Care
Brief Summary: Patients with advanced illness and their families confront a number of issues ranging from distressing symptoms to making complex decisions that affect quality of life and survival. Patients and family members struggle with these decisions even more when they feel ambivalence or reluctance. The investigator's overarching goal is to enhance provision of high quality, patient-centered care for patients with advance illness and their families and to reduce burnout among palliative care clinicians. The investigator will apply a well-established approach to achieving clinician/patient alignment in the primary care setting, Motivational Interviewing (MI) to a new population and setting, palliative care.


Options:
A: Hospital Anxiety and Depression Scale (At 6 months)
B: Is there a change in patient understanding of prognosis with the addition of a palliative care intervention? (6 months)
C: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)
D: Aim 1: feasibility and acceptability of learning Motivational Interviewing techniques by palliative care clinicians (Through study completion, an average of 1 year.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Exercise and Exercise Counselling in Hemodialysis Patients: a Randomized Controlled Trial.
Brief Summary: The aim of the study is to determine the effect of functional exercise and training counseling by kinesiotherapist in addition to the basic exercise program of cycling during dialysis on physical performance of dialysis patients.


Options:
A: Change in Body Heat Storage (Changes from baseline at 7 months); Change in Insulin Resistance (Changes from baseline at 7 months); Change in Muscle Size (Changes from baseline at 7 months)
B: Physical Activity (Baseline and 12 weeks)
C: Change in 10 repetition sit-to-stand test time (baseline, 8 weeks and 16 weeks)
D: Number of patients who correct the state of protein energy wasting in intervention group compared to a control group (at 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
Brief Summary: Raised blood pressure is a common problem in pregnancy. Raised blood pressure and pre-eclampsia affect about one in ten women and are a major cause of death and premature birth in the United Kingdom and worldwide.

Many women have expressed an interest in monitoring their own blood pressure in between antenatal visits but there has been very little research to guide this. The investigators would like to know if the diagnosis and subsequent care of women with raised blood pressure can be improved if women were able to monitor their own blood pressure safely at home. This work will test whether optimising the diagnosis, monitoring and management of raised BP during pregnancy through self-monitoring of BP is effective, acceptable and cost-effective compared to usual care.

The research team have being working with pregnant women, doctors and midwives to develop a simple and accurate method of self-monitoring of blood pressure in pregnancy.

This randomised controlled trial will:

1. Compare self-monitoring with usual care in women at higher risk of hypertension in pregnancy and assess if self-monitoring can identify raised blood pressure earlier.
2. Compare self-monitoring with usual care for women with high blood pressure in pregnancy to see if it leads to lower blood pressure.
3. Assess if self-monitoring is cost-effective.

Pregnant women who chose to take part in these studies will be randomised to either usual care or asked to monitor their own blood pressure during their pregnancy in addition to their usual antenatal care.


Options:
A: Niccomo measurement (10 weeks of pregnancy); Niccomo measurement (20 weeks of pregnancy); Systolic and Diastolic Blood pressure monitoring (10 weeks of pregnancy); Systolic and Diastolic Blood pressure monitoring (20 weeks of pregnancy); a maternal Venous Doppler Echochraphy (10 weeks of pregnancy); Maltron measurement (10 weeks of pregnancy); a maternal Venous Doppler Echochraphy (20 weeks of pregnancy); Maltron measurement (20 weeks of pregnancy); Activity tracker (10 weeks of pregnancy); Weight (10 weeks of pregnancy); Activity tracker (20 weeks of pregnancy); Weight (20 weeks of pregnancy)
B: Recruitment rate (6 months); Retention rate (Till the follow-up period (from 20 weeks to until delivery or termination of the pregnancy) ends); Adherence to protocol (compliance) (5 months); Acceptability of the device (5 months); Acceptability of the BP measurement (5 months)
C: The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).
D: Time from recruitment to diagnosis of raised blood pressure (From study entry to delivery i.e. up to approximately 25 weeks from recruitment); Mean systolic blood pressure (From study entry to delivery i.e. up to 40 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Empowerment as a Mechanism for Change in Childhood Obesity Prevention
Brief Summary: The Communities for Healthy Living (CHL) program is a family-focused intervention to promote healthy lifestyle behaviors including diet and physical activity among children (age 3-to 5-years) and their families, enrolled in Head Start.


Options:
A: Difference Between Interventions in Vegetable Intake (One meal per week for each intervention (Study weeks 1, 2, 3, and 4))
B: Fruit and vegetable acceptance (post intervention) (The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).); Relative fruit and vegetable acceptance (post intervention) (The parents filled in the questionnaire after the intervention (4-5 weeks after the onset of the intervention).)
C: Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices (From Baseline Up to 8 months)
D: Change in Child BMI-z score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned); Modified change in BMI z-score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Empowerment as a Mechanism for Change in Childhood Obesity Prevention
Brief Summary: The Communities for Healthy Living (CHL) program is a family-focused intervention to promote healthy lifestyle behaviors including diet and physical activity among children (age 3-to 5-years) and their families, enrolled in Head Start.


Options:
A: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
B: Change in Child BMI-z score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned); Modified change in BMI z-score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2))
C: Change in Child Physical Activity (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.); Change in Child Dietary Intake (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
D: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exploratory, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-Old Adults
Brief Summary: The purpose of this study is to assess a trend for the prophylactic efficacy of a single dose of 1\*10\^11 virus particles (vp) of adenovirus serotype 26 respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) administered intramuscularly to adults aged 18-50 years in the respiratory syncytial virus (RSV) challenge model in terms of reduction of nasal wash viral load compared to placebo.


Options:
A: Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (Days 0-28) (Measured through Day 28); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through study follow-up period, up to 1 year after study entry)
B: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
C: Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) (From Day 2 to Day 12)
D: Number of Participants With Solicited Adverse Events (AEs) by Grade (Measured from Day 0 through Day 28); Number of Participants With Unsolicited AEs by Grade (Measured from Day 0 through Day 28); Number of Participants With Serious Adverse Events (SAEs) (Measured from Day 0 through Day 56); Number of Participants Infected With RSV Vaccine (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies); Peak Titer of Vaccine Virus Shed (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28); Duration of Virus Shedding in Nasal Washes (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.); Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer (Measured at Day 0 and Day 56); Serum Antibody Responses to RSV F Glycoprotein as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) (Measured at Day 56)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
Brief Summary: To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review.


Options:
A: Progression Free Survival (PFS) (Time from study entry to the time of documented disease progression or death. The analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years.)
B: Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) (Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021))
C: Progression-free Survival (PFS) (Median observation time at time of analysis was approximately 21 months); Final Analysis: Time to Progression-free Survival Event (Median observation time was approximately 66.4 months)
D: Progression Free Survival (PFS) (Up to 2 years 10 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of a Nutritional Supplement (Impryl®) on Male Fertility
Brief Summary: Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples a male factor is involved. Male infertility is of multifactorial origin. In the past decade, the role of oxidative stress on sperm has been researched thoroughly and found to be the problem in 30% to 80% of male infertility cases.

Impryl® is a nutritional supplement mainly consisting of vitamin B, which works on the metabolic system by activating the one carbon cycle and recycling of homocysteine without the use of any direct strong antioxidants.

In this study the investigators want to determine the effectiveness of nutritional supplement Impryl® in men of infertile couples on ongoing pregnancy rate, with or without assisted reproduction technology (ART).


Options:
A: Ongoing pregnancy rate (15 months)
B: sperm motility (12 weeks)
C: Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels. (up to three months.)
D: Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate (4 weeks to 9 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors in the Hospital Pablo Tobon Uribe- Colombia
Brief Summary: Medication errors are considered by WHO to be a subject that requires attention at all levels of care, in order to reduce the serious and preventable damage related to medication.

These strategies are aimed at the patient's safety policy. In Colombia, at the regulatory level there is no standardized clinical pharmacy model where the role of the clinical pharmacist is described extensively and in detail, and in addition, data are unknown of the scope or direct effect of the incorporation of this model in the assistance in the results of health care.

The Hospital Pablo Tobón Uribe, it is a highly complex institution in Medellin (Colombia), certified by Join Comission International (JCI), which requires the continuous interaction of the pharmacist in patient care, in order to avoid medication errors and contribute to patient safety indicators. In this sense, the hospital structured and implemented a clinical pharmacy model that establishes the activities of the pharmacist incorporated into the care team in the patient attention. Today this model is applied in the institution, however, it is necessary to know the effect of its application in the solution of drug-related problems (DRPs) or a negative outcome related to medicine. The objective of this study is to know the effect on patient safety of a clinical pharmacy model in a hospital of high complexity and framed in the WHO initiative to reduce these errors of medication.


Options:
A: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
B: The probability of developing medication errors over a certain period of time and recommendations to avoid such errors. (2 months)
C: ADEs (Measured 30 and 90 days after hospital discharge); Medication appropriateness (Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index); Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE (Measured 30 and 90 days after hospital discharge); Cost-effectiveness of the minimal or enhanced treatment compared to usual care (Measured 30 and 90 days after hospital discharge)
D: Effects on hospital visits (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors in the Hospital Pablo Tobon Uribe- Colombia
Brief Summary: Medication errors are considered by WHO to be a subject that requires attention at all levels of care, in order to reduce the serious and preventable damage related to medication.

These strategies are aimed at the patient's safety policy. In Colombia, at the regulatory level there is no standardized clinical pharmacy model where the role of the clinical pharmacist is described extensively and in detail, and in addition, data are unknown of the scope or direct effect of the incorporation of this model in the assistance in the results of health care.

The Hospital Pablo Tobón Uribe, it is a highly complex institution in Medellin (Colombia), certified by Join Comission International (JCI), which requires the continuous interaction of the pharmacist in patient care, in order to avoid medication errors and contribute to patient safety indicators. In this sense, the hospital structured and implemented a clinical pharmacy model that establishes the activities of the pharmacist incorporated into the care team in the patient attention. Today this model is applied in the institution, however, it is necessary to know the effect of its application in the solution of drug-related problems (DRPs) or a negative outcome related to medicine. The objective of this study is to know the effect on patient safety of a clinical pharmacy model in a hospital of high complexity and framed in the WHO initiative to reduce these errors of medication.


Options:
A: Incident adverse drug reactions (ADRs). at least one likely or certain, non-trivial hospital acquired ADR. (Day 14 of hospital stay or discharge, which ever comes first)
B: The probability of developing medication errors over a certain period of time and recommendations to avoid such errors. (2 months)
C: Total Number of Medications (Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC)
D: Rate of readmission (30 days)

Answer: B