TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Pilot Trial to Compare Remote Blood Glucose Monitoring With Standard Clinical Care in the Gestational Diabetic Population
Brief Summary: Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to problems for both mothers-to-be and their babies such as causing a large baby and difficult birth. Gestational diabetes in the mother may also lead to effects on the long term health of the baby.

Most people today use mobile phones. Our research is looking at using a mobile phone app to help with diabetes care in pregnancy. In particular, the investigators are using phones which connect to the standard blood glucose monitoring machines given to all women with gestational diabetes to see if sending the hospital team blood test results between clinic appointments can result in the need for fewer clinic visits. The investigators are also testing to see how acceptable using mobile phones in this way, is to our patients and that the control of the blood glucose and outcomes for the mother and baby are at least as good as standard care.

The investigators are planning to recruit 200 women who receive care for their gestational diabetes at the Oxford University Hospitals NHS (National Health Service) Trust. They will be randomised so that 100 will receive standard care, and 100 will have a mobile phone "app" linked to the blood glucose machines to send blood glucose readings directly to the diabetes care team to review.

Both groups will be asked to test their blood glucose levels at home regularly with a glucometer. All participants will also be given lifestyle advice to reduce the chance they will need medication. Blood glucose control will be measured also by the percentage of glycated hemoglobin (HbA1c) at the time of diagnosis of gestational diabetes and before delivery.


Options:
A: Framingham 10-year risk index (1 year)
B: Glycosylated haemogloblin (8 weeks from recruitment at 28 weeks gestation to 36 weeks gestation)
C: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
D: Patient satisfaction (At 36-39 weeks gestation); Health care staff satisfaction (At completion of the study estimated to be January 2013); Management decision comparison (At weekly clinic or telemonitoring review from time recruited into study to delivery, estimated at an average of twelve weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of MiSight ® Contact Lenses in Reducing the Progression of Childhood Myopia, Not Pathological, Aged 8-12 Years Randomized Clinical Trial.
Brief Summary: The purpose of the study is to quantify the effectiveness of CooperVision MiSight® (omafilcon A) soft (hydrophilic) contact lens in slowing the rate of progression of juvenile-onset myopia.


Options:
A: Change in the spherical equivalent refractive error relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months); Change in axial length relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months); Measurement of corneal curvature (keratometry)relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months)
B: Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (Baseline to 3 years); Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years (3 years)
C: Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study (2 years)
D: Cycloplegic autorefraction (Baseline, 6, 12, 18, and 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of MiSight ® Contact Lenses in Reducing the Progression of Childhood Myopia, Not Pathological, Aged 8-12 Years Randomized Clinical Trial.
Brief Summary: The purpose of the study is to quantify the effectiveness of CooperVision MiSight® (omafilcon A) soft (hydrophilic) contact lens in slowing the rate of progression of juvenile-onset myopia.


Options:
A: Change in the spherical equivalent refractive error relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months); Change in axial length relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months); Measurement of corneal curvature (keratometry)relative to baseline. (Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months)
B: Spherical equivalent refraction determined by cycloplegic autorefraction
C: Spherical Equivalent Refractive Error (Baseline and every 6 months post-baseline for 2 years)
D: Axial length (every 6 monthly in 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone+Formoterol+Glycopyrrolate to Foster® in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of treatment


Options:
A: Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI (Up to Week 52)
B: Moderate and severe COPD exacerbation rate over 52 weeks of treatment (1 year)
C: Adjusted Rate of Moderate or Severe Exacerbations (52-week treatment period)
D: Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at week 26 (week 26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Africa and Asia. The aim of the trial is to investigate the efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with metformin during Ramadan in subjects with type 2 diabetes (T2DM).


Options:
A: HbA1c + weight loss (Baseline and 3-4 weeks post-Ramadan)
B: Change in HbA1c (Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan))
C: Change in Fructosamine From Start of Ramadan to End of Ramadan (Day -1, day 29)
D: Percentage of Participants With at Least One Symptomatic Hypoglycemic Event (Up to 30 days (Day 1 through last day of Ramadan))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Dose Aspirin and Low-molecular-weight Heparin in the Treatment of Pregnant Libyan Women With Recurrent Miscarriage
Brief Summary: Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages.


Options:
A: Number of miscarriages (3 months)
B: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)
C: Pregnancy continuation beyond twelve weeks gestation (ONE YEAR)
D: ongoing intact pregnancy at 24 weeks of gestation (at 24 weeks of gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: mActive: A Blinded, Randomized mHealth Trial of Digital Activity Tracking and Smart Texting to Promote Physical Activity
Brief Summary: Despite their importance, health-related behaviors are hard to change. Among behaviors, physical activity is associated with protection from multiple diseases. People who are physically active have lower risk for heart disease, stroke, type 2 diabetes, depression, and some cancers with associated dose-dependent reductions in cardiovascular and all-cause mortality. However, most US adults do not meet CDC physical activity guidelines. Sedentary work behavior in industrialized nations is likely a contributor to this problem.

Current low-technology strategies for encouraging lifestyle change are disappointingly ineffective and are highly resource intensive. Systematic reviews of the literature show mixed evidence for using activity trackers (i.e., pedometers) and a limited body of evidence for text messaging in preventive health care. However, prior studies have not integrated digital activity tracking with mobile phone text messaging feedback.

Given 91% of adults in the United States now use a mobile phone, and 56% a smartphone, this represents a potentially widely applicable avenue for therapeutic intervention. There is growing interest in leveraging mobile health (mHealth) technologies to improve health behaviors in the general population. The investigators propose to conduct a blinded, randomized mHealth trial of digital activity tracking and smart texting to promote physical activity.


Options:
A: Changes in MVPA (Moderate-to-Vigorous Physical Activity) bouts of participants from baseline to months 6 and 12 (Baseline, 6 and 12 months)
B: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (End of program (6 months))
C: Mean Daily Step Count (Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)); Mean Daily Step Count (Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention))
D: Change in walking activity from admission to discharge from rehabilitation (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)); Change in control of walking (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Lifestyle Intervention in Pregnancy - Follow-up on the Offspring in Early Childhood.
Brief Summary: Children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. This present study follows the children until 3 years of age. We have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. Clinical examination is taking place at age 2.5-3 years including anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring metabolic markers.


Options:
A: Weight Gain Per Week of Observation (13 weeks gestation, 35 weeks gestation)
B: Weight gain and nutritional status in mothers (36-40 weeks of gestation); Weight retention (12 months post-partum); Glycaemic control (At 20-24 weeks of pregnancy); Lactation rates (At 12 months post-partum); Initiation and duration of breastfeeding (exclusive and total) (Birth-12 months); Weight, length and BMI growth in infants (During the first year of life); Psychomotor development (based on abbreviated scale) (During the first year of life)
C: Maternal Weight Change (baseline to 2 weeks post partum)
D: Body Mass Index standard deviation score (On average 2.9 years of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Lifestyle Intervention in Pregnancy - Follow-up on the Offspring in Early Childhood.
Brief Summary: Children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. This present study follows the children until 3 years of age. We have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. Clinical examination is taking place at age 2.5-3 years including anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring metabolic markers.


Options:
A: Child body mass standard deviation score (On average 2.9 years of age)
B: Number of at risk participants developing GDM during pregnancy
C: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)
D: Body Mass Index standard deviation score (On average 2.9 years of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Lifestyle Intervention During Pregnancy in Obese Women on Offspring Adiposity and Metabolic Risk Factors- Comparison With Offspring of Normal Weight Women Not Participating in a Lifestyle Intervention Programme.
Brief Summary: Children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. This present study follows the children until 3 years of age. We have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. Clinical examination is taking place at age 2.5-3 years including anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring metabolic markers.In addition, we have included an extra control group of children born to normal weight women, who were not part of a lifestyle intervention program during pregnancy. We have the hypothesis that the children of the normal weight women have a better metabolic profile than the children born to the obese women.


Options:
A: Child body mass standard deviation score (On average 2.9 years of age)
B: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
C: Diet; Physical Activity
D: Maternal Weight Change (baseline to 2 weeks post partum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Lifestyle Intervention During Pregnancy in Obese Women on Offspring Adiposity and Metabolic Risk Factors- Comparison With Offspring of Normal Weight Women Not Participating in a Lifestyle Intervention Programme.
Brief Summary: Children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. This present study follows the children until 3 years of age. We have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. Clinical examination is taking place at age 2.5-3 years including anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring metabolic markers.In addition, we have included an extra control group of children born to normal weight women, who were not part of a lifestyle intervention program during pregnancy. We have the hypothesis that the children of the normal weight women have a better metabolic profile than the children born to the obese women.


Options:
A: Diet; Physical Activity
B: Child body mass standard deviation score (On average 2.9 years of age)
C: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
D: Maternal gestational weight gain (40-42 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up of Patients With the Apnea-hypopnea Syndrome in Primary Care and Sleep Disorders Units. Equivalence Randomized Comparative Study on Compliance and Clinical Response.
Brief Summary: The objective of the study is to compare the results of a coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation.

Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index \>=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use \>= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.


Options:
A: Differences in compliance among the three different strategies, measured by CPAP hours of use (six months follow-up)
B: CPAP Adherence (1 month); CPAP Adherence (6 months)
C: CPAP Therapy Adherence (30 days post in-lab split night polysomnogram)
D: Number of hours of use per day of CPAP (Six month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Point-of-care (POC) C-reactive Protein Testing to Reduce Inappropriate Use of Antibiotics for Acute Respiratory Infections (ARIs) in the Primary Health Care Setting of Hanoi - a Randomized Controlled Trial
Brief Summary: Many studies have showed that rapid point-of-care (POC) c-reactive protein (CRP) test can reduce inappropriate use of antibiotic at primary health care level. In Vietnam, prevalence of antibiotic abuse for community acute respiratory infection has been reported. This study will test the hypothesis that CRP POC testing for patients with non-severe acute respiratory illness at primary healthcare stations reduces inappropriate antibiotic use safely.

The study will be conducted at ten district health care facilities in Hanoi, Viet Nam. Investigators intend to enroll 2,000 participants aged 6-65 years with non-severe acute respiratory infection. Patients will be randomly allocated to the control or the intervention arm. Participants in the control group will be treated according to routine care. Participants in the intervention arm will have a CRP test, the results of which will be available to the health care practitioner to contribute to their diagnosis and treatment decisions.

All patients will be followed-up via telephone call after 14 days. The study will compare the proportion of patients in each arm receiving any antibiotics within 2 weeks of study enrollment.


Options:
A: Proportion of patients receiving any antibiotic (2 weeks)
B: The proportion of recruited patients prescribed an antibiotic (6 Days)
C: the antibiotic prescribing rate (within the first 2 weeks after first consultation)
D: Change in antibiotic prescription patterns for respiratory infections (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)
Brief Summary: The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower their systolic blood pressure.


Options:
A: Reduction of systolic blood pressure (Baseline to 3 and 12 months.)
B: Reduction in systolic blood pressure taken by study team at home visit (12 months)
C: Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death (Up to 6 years from inclusion)
D: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome. A Randomized Controlled Trial
Brief Summary: The aim is to investigate whether strength training or high intensity interval training is effective in improving insulin sensitivity, cardiovascular outcomes, body composition and reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS).

Few studies have examined the effect of strength training alone on insulin sensitivity, reproductive outcomes and body composition in women with PCOS. Most previous studies on aerobic exercise in PCOS have applied moderate exercise intensity.


Options:
A: Insulin sensitivity (IVGTT and minimal model)
B: Improving reproductive and metabolic outcomes of women with PCOS (8 weeks)
C: insulin resistance (10 weeks)
D: Weight loss (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression (TRD)
Brief Summary: This study is looking at the efficacy, durability, safety, and tolerability of multiple single doses of Ketamine vs. active placebo for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.


Options:
A: Observed and laboratory-confirmed safety (four weeks)
B: To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score (Baseline to week 3)
C: Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) (Up to 7 days following the last dose of study drug (Up to 23 days)); Part 1: Number of Participants With Serious Adverse Events (SAEs) (Up to 30 days following the last dose of study drug (Up to 46 days)); Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 16 days)); Part 2: Number of Participants With AEs (Up to 7 days following the last dose of study drug (Up to 35 days)); Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 28 days))
D: Hamilton Rating Scale for Depression - 6 Items (A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1, & 3)

Answer: D