TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: PEARL Intervention to Reduce Depression Among Adults With Epilepsy
Brief Summary: The purpose of this study is to test the effectiveness of a home-based depression treatment intervention called "Program to Encourage Active, Rewarding Lives (PEARL)". We hypothesize that over a 12-month period, compared to usual care, those receiving the PEARL intervention will show more improvement with their depression, have higher quality of life and function, and use fewer medical services.


Options:
A: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)
B: the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms) (16 weeks)
C: 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
D: Recovery from Common Mental Disorder (defined by ICD10) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PEARL Intervention to Reduce Depression Among Adults With Epilepsy
Brief Summary: The purpose of this study is to test the effectiveness of a home-based depression treatment intervention called "Program to Encourage Active, Rewarding Lives (PEARL)". We hypothesize that over a 12-month period, compared to usual care, those receiving the PEARL intervention will show more improvement with their depression, have higher quality of life and function, and use fewer medical services.


Options:
A: Physical activity measured by pedometer. (2 years); Healthy eating index quantified by the Food Frequency Questionnaire. (2 years)
B: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)
C: a weight loss of 7% in at least 19% of the subjects (one year); reduced body weight of at least 5.6 kg in at least 25% of the subjects (one year); an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects (one year); a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects (one year); a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects (one year)
D: HIV-1 seroincidence; HSV2 seroprevalence

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence Feedback for Improving Respiratory Medication Use
Brief Summary: The purpose of this study is to determine whether providing patient medication adherence information on inhaled corticosteroid use to clinicians will result in improved patient adherence and asthma control.


Options:
A: Percentage of Visits With Appropriate Hypertension Management (1 month clinic visit)
B: Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group (12 months)
C: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
D: Proportion of patients achieving hypertension control (6 months after enrollment); change in systolic and diastolic blood pressure (6 months after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence Feedback for Improving Respiratory Medication Use
Brief Summary: The purpose of this study is to determine whether providing patient medication adherence information on inhaled corticosteroid use to clinicians will result in improved patient adherence and asthma control.


Options:
A: Change From Baseline in Morning Peak Expiratory Flow (PEF) (Baseline and Week 12)
B: N/A
C: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
D: Subject's height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject's stadiometer height data

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence Feedback for Improving Respiratory Medication Use
Brief Summary: The purpose of this study is to determine whether providing patient medication adherence information on inhaled corticosteroid use to clinicians will result in improved patient adherence and asthma control.


Options:
A: Asthma-related morbidity (Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)
B: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
C: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
D: Change in Asthma Control Test Scores (Baseline and Six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence Feedback for Improving Respiratory Medication Use
Brief Summary: The purpose of this study is to determine whether providing patient medication adherence information on inhaled corticosteroid use to clinicians will result in improved patient adherence and asthma control.


Options:
A: medication adherence (1 year)
B: Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators. (First a Pilot in 3 months and then the final study in 6 months)
C: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
D: Change in asthma control from baseline at 3 months (3 months); Change in asthma control from baseline at 6 months (6 months); Change in asthma control from baseline at 9 months (9 months); Change in asthma control from baseline at 12 months (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial Comparing Conventional vs Short-course Reduced Volume Conformal Post-surgery Radiation Treatment in Women With Stage I or II Breast Cancer
Brief Summary: Tomotherapy is a new radiation therapy system that uses an integrated CT scanner during delivery of radiation treatment to improve the accuracy of the treatment. Furthermore the irradiation is delivered helicoidally allowing highly conformal shaping of dose distribution. However the magnitude of the clinical advantage of using the system in breast cancer is unknown. The purpose of the present study is to investigate whether or not the Tomotherapy can substantially reduce pulmonary and cardiac toxicities, as compared with conventional radiotherapy.


Options:
A: Change from baseline in pulmonary function and heart function tests (From end of treatment up to 3 years after treatment)
B: Number of Participants With Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis (3 years after completing radiation therapy)
C: Duration of DFS (Time from registration to first adverse event, assessed up to 15 years)
D: Local breast recurrence (Indefinitely)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg
Brief Summary: The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.


Options:
A: ARR - PDEs (Baseline to Month 36)
B: Flu-like-syndrome (309 days); Injection-site Reactions (309 days); Liver Enzyme Elevations (309 days); Hematological Abnormalities (309 days)
C: Time to First Relapse (Baseline up to 96 weeks)
D: Hazard ratio for relapses (During the first and during the second 52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc and Bone Metabolism in Thalassemia
Brief Summary: The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia.


Options:
A: Bone density by means of bone densitometry with dual energy x-ray absorptiometry (DEXA) at three body sites (lumbar region, femoral head, wrist) prior to treatment initiation the start and at the end of treatment; N-telopeptide of type I collagen (NTx) levels, TRACP-5b, with ELISA, prior to the start of treatment initiation and every 3 or 6 months; Serum Bone alkaline phosphatase, Osteocalcin, OPG and S-RANKL with ELISA, prior to the start of treatment initiation, and every 3 or 6 months
B: The percent change in the lumbar spine BMD (12 months)
C: Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months) (0 to 18 months); Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months) (Baseline to 18 months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation
Brief Summary: Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.


Options:
A: risk of failure on the first attempt of endotracheal intubation
B: Intubation Time (At intubation)
C: CERVICAL MOTIONS (January 2011 and December 2012)
D: Time to intubation (seconds) (Immediate)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
Brief Summary: The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.


Options:
A: proportion of patients with breastfeeding completed at 6 months (6 months)
B: Changes in maternal stress from baseline to 8 weeks postpartum (8 weeks)
C: Postpartum weight retention (no more than 1.5 years)
D: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
Brief Summary: The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.


Options:
A: Waist Circumference (Month 9); Body Weight (nine month); Body Weight (4 month); Waist Circumference (4 month)
B: Postpartum weight retention (no more than 1.5 years)
C: Weigtreduction; Increase in maximum oxygen uptake; Change in foodintake; Change in self-reported activity
D: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
Brief Summary: The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.


Options:
A: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
B: Postpartum weight retention (no more than 1.5 years)
C: Neonatal mortality rate
D: Percent of infants breastfed exclusively (4 weeks of age); Daily volume of formula supplement received by mixed feeders (at 4 weeks of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
Brief Summary: The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.


Options:
A: The Rate of Macrosomia. (At the time of birth.)
B: Postpartum weight retention (no more than 1.5 years)
C: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
Brief Summary: The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.


Options:
A: Postpartum weight retention (no more than 1.5 years)
B: Infant weight for height (One year after study entry)
C: Changes in the knowledge and belief about postpartum practice among the women (December 2009)
D: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
Brief Summary: The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.


Options:
A: Primary outcome: meeting the postpartum weight goal (through 12 months postpartum)
B: Brachial artery flow-mediated dilation (Baseline, 8 weeks, 16 weeks)
C: Postpartum weight retention (no more than 1.5 years)
D: Maternal gestational weight gain (40-42 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
Brief Summary: The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.


Options:
A: To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. (at participant post-partum visit)
B: Postpartum weight retention (no more than 1.5 years)
C: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
D: Breastfeeding at 3 months and at 6 months (3 months and six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Exercise and Breastfeeding Intervention (DEBI) Program for Women With Gestational Diabetes
Brief Summary: The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.


Options:
A: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)
B: Exclusive breastfeeding (6 months postpartum)
C: Postpartum weight retention (no more than 1.5 years)
D: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial
Brief Summary: Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT)® at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence.


Options:
A: Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence (3 months post-surgery); Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery (12 months post-surgery)
B: Recurrence of anterior vaginal wall prolapse
C: Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (one year)
D: Stress urinary continence (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine MVA85A, in Healthy Volunteers With no Evidence of Infection With Mycobacterium Tuberculosis, in Cape Town
Brief Summary: This study is designed to evaluate the safety of MVA85A in healthy volunteers in Cape Town. We have shown that MVA85A is safe and immunogenic in both a mycobacterially naïve population in the UK and in a more mycobacterially exposed population in The Gambia. The studies described here will be to assess the safety of MVA85A in 2 groups of adults, those with and without prior BCG vaccination. Once safety data has been obtained in these 2 groups, we will assess the safety of MVA85A in adolescents who have been previously vaccinated with BCG.


Options:
A: The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each mmunisation (and after 7 days).; Blood will be taken at: the screening visit, prior to the BCG vaccination, 1 and 4 weeks after the BCG vaccination, and also at 1,4, 8, 12 and 24 weeks after the MVA85A vaccination.
B: Safety of the Vaccine. This will be determined by the degree and number of adverse events reported.
C: To assess the safety of a single intradermal injection of 5 x 107pfu MVA85A, when administered to healthy subjects. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events (AEs). (year)
D: The occurence and severity of local side-effects The occurence and severity of systemic side-effects (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)
Brief Summary: The survey is designed to identify non-compliant Attention Deficit Hyperactivity Disorder (ADHD) patients who are currently on Immediate- Released Methylphenidate (IR-MPH) and observe any change in compliance after treating with other drugs intended to treat ADHD for over 3 weeks


Options:
A: SKAMP deportment rating scale (Week 8)
B: N/A
C: The change from survey day 1 to first visit in Clinical Global Impression score (3 weeks)
D: Dermal Reactions (7 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
Brief Summary: This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Options:
A: Absolute change from baseline in HbAlc (Week 8)
B: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 (Baseline and Week 16)
C: Change in HbA1c From Baseline to Week 26 (Baseline, Week 26)
D: Percentage of patients withdrawn because of gastrointestinal effects (Week 9)

Answer: D