TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus
Brief Summary: It is well-known that women with previous gestational diabetes mellitus are in risk of developing type 2 diabetes later in life; approximately half of the women develop overt type 2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.


Options:
A: Change in Reactive Hyperemic Index Over the 3-month Treatment Period (Change from baseline to 3 months)
B: Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism (120 minutes after exenatide or placebo injection)
C: Change in glucose tolerance (from baseline to 52 wks, 53 wks, 260 wks, and 261 wks)
D: Inflammatory Biomarker 1: Plasma hsCRP Concentration (2 months); Inflammatory Biomarker 2: Plasma IL-6 Concentration (2 months); Inflammatory Biomarker 3: Serum D-dimer Concentration (2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Families Improving Together (FIT) for Weight Loss
Brief Summary: The increasing rate of obesity has become a major public health concern with national reports indicating 40% of African American adolescents are now overweight/obese. Little is known about effective weight loss interventions in ethnic minority adolescents. However, research has shown that ethnic minorities attend fewer intervention sessions, have higher attrition rates and lose less weight compared to Caucasians. Two fundamental problems related to this lack of progress are 1) lack of appropriate content of weight loss interventions for African American adolescents that integrate cultural issues, parenting skills, and motivational strategies for long-term change and, 2) poor dose of weight loss interventions because of participant fatigue and drop out. While previous weight loss studies for adolescents have been long lasting (12-25 weeks), our team developed a weight loss program that is a relatively brief (8-week) face-to-face intervention that integrates motivational (autonomy-support) and positive parenting skills (monitoring, social support, positive communication skills) for reducing z-BMI in overweight African American adolescents. Our team recently conducted a pilot study testing the feasibility of an 8-week on-line culturally tailored intervention, Thus, the goal of this project is to conduct a randomized controlled efficacy trial to address the problems with past studies by 1) making the face-to-face group intervention shorter, 2) using an on-line component to compliment the group-based intervention for increasing dose, and by 3) tailoring a motivational and parenting skills program directly to parents and adolescents skill levels and cultural background. 520 overweight African American adolescents and their parents will be recruited to participate. Phase I of the trial will test the efficacy of an 8-week face-to-face group randomized trial comparing motivational plus family-based weight loss (M+FWL) to a basic health (BH) education program on reducing z-BMI and improving diet and physical activity (PA) in overweight African American adolescents. In phase II of the trial participants will be re-randomized to either an 8-week on-line intervention or a control on-line program resulting in a 2 (M+FWL vs. BH group) x 2 (intervention vs. control on-line program) factorial design. A 6-month follow-up will examine whether adolescents in the 8-week M+FWL group plus 8-week on-line intervention program will show the greatest maintenance in reducing z-BMI.


Options:
A: Change in Body Mass Index (z-BMI) in Adolescents (Baseline to 2 months); Change in Body Mass Index (z-BMI) in Adolescents (Baseline to 4 months); Change in Body Mass Index (z-BMI) in Adolescents (Baseline to 6-month follow-up)
B: Frequency of binge eating; weight
C: Change in Adolescent Body Mass Index (BMI) (12 and 24 months)
D: change in percent body fat (MRI scan) (end of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of DHA (DOCOSAHEXAENOIC ACID) on Attention Deficit and Hyperactivity Disorder
Brief Summary: The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in reducing Attention Deficit/Hyperactivity Disorder (ADHD) core symptoms in a clinical sample of children and adolescents with ADHD.


Options:
A: Change in reading ability (0, 3 and 6 months)
B: Cognitive control task - functional MRI (change over 16 week intervention period (pre/post))
C: Change in ADHD RS-IV total score (Baseline, month 4, and month 6)
D: Conners Rating Scale - School Version (change from baseline in conners raiting scale at 15 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Home Monitoring Versus Hospitalization in Mild Non-Alcoholic Acute Interstitial Pancreatitis
Brief Summary: Acute pancreatitis (AP) is considered a disease requiring in-hospital treatment. We studied the feasibility of home management in AP.The aim of study was to compare 30 day readmission rates in patients with mild non-alcoholic acute pancreatitis (NAAP) randomized to home monitoring versus hospitalization.


Options:
A: The primary outcome of the study was the 30 day hospital readmission rate. (30 days)
B: Anxiety and depression (HADS) (At 1 month, 3 months and 12 months, change from baseline)
C: Change in HADS-A score from baseline to three months follow-up (Three months)
D: Walking distance at 6 months post surgery, measured using the Six-Minute Walk Test (6MWT) (Pre surgery; 10 weeks, six months and twelve months after surgery.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Masked, Multicenter, Two Arm Study Comparing the Efficacy and Safety of ESBA1008 Versus EYLEA® in Subjects With Exudative Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in the treatment of exudative age-related macular degeneration.


Options:
A: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations (From Baseline through Week 56)
B: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)
C: Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 (Baseline (Day 0), Week 12)
D: Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants (Baseline, Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of the Metabolic Effects of Fructose, Glucose, High Fructose Corn Syrup and Sucrose at Normal Population Consumed Levels on Liver and Muscle Fatty Infiltration, Insulin Resistance, Glucose, Insulin, Leptin, Ghrelin, Postprandial Triglycerides, LDL Particle Size, Uric Acid and Appetite in Adults Aged 20-60 Years Old
Brief Summary: The purpose of this study is to investigate the acute and chronic effects of consumption fructose containing sugars and glucose in a real word setting when consumed in a manner and amount typical in the American diet.


Options:
A: Changes in the acute metabolic and hormonal response (glucose, insulin, leptin, active ghrelin, triglycerides, uric acid) (Baseline and 10 weeks); Changes in fat content of skeletal muscle and liver (Baseline and 10 weeks)
B: Dietary intake (6 month)
C: Physical Activity Energy Expenditure (kJ/Day or kcal/Day) (7 days (across 12 weeks) - Primary outcome at week 4)
D: Cardiovascular Disease Prevention based on dietary approach. (Two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Catheter Reminder and Evaluation (CARE) Program in Reducing the Catheter-day and Prevention of Catheter-associated Infections
Brief Summary: The investigators will conduct a cluster randomized controlled trial to evaluate the efficacy of Catheter Reminder and Evaluation program (CARE) in reducing the duration of catheter use and the number of infection relating to catheter use.


Options:
A: Successful completion of follow-up colonoscopy; Number of patients completing colonoscopy during the study period
B: The primary outcome is the proportion of patients starting prescription osteoporosis treatment within 3 months of fracture recognition (3 months)
C: Episiotomies; Oxytocin use in third stage of labor
D: Urinary catheter day (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
Brief Summary: Background: The end of treatment is for cancer patients the beginning of a critical rehabilitation period including numerous physical, emotional, professional and cognitive challenges. Specific interventions adapted to this post-treatment period need thus to be designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been shown to be effective. However, moderate effect sizes, no comprehensive description of the treatment interventions and assessments relying only on self-report measures warrant further investigation. This study aims to assess, in breast cancer patients at the end of treatment, the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus a group intervention on patient's adjustment and emotion self-regulation.

Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer patients finishing their radiation therapy treatment will be randomized to either an immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group intervention. Patients will be assessed at three time points during the first year following the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment. Patients' adjustment will be assessed through questionnaires. Patient emotion self-regulation ability will be assessed through their ability to respond both subjectively (self-reported emotional state) and objectively (heart rate) to two emotion self-regulation tasks.

Discussion: It is hypothesized that a group intervention combining cognitive-behavioral therapy and hypnosis will be more effective than a group intervention. Results of this study will contribute to improving post-treatment care for breast cancer patients.


Options:
A: Oral morbidity (Up to two years)
B: To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors) (6 weeks)
C: Stress (20 months)
D: Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...) (Change from baseline in heart rate and relaxation ability at 6 (T2) and 12 months (T3)); Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,... (Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Control Trial on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth
Brief Summary: The purpose of this randomized clinical trial is to compare the clinical effectiveness of three treatments involving different caries management strategies (conventional restorations, Hall technique, and Non-Restorative Caries Treatment) to the management of class II carious primary molars in children (3-8 year-old).


Options:
A: restauration evaluation (18 months)
B: Failure Rate of the Three Treatment Arms Judged Clinically (2 years)
C: Pair-wise radiographic lesion progression (1, 2, and 3 years)
D: Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control. (1year control data for all treatments primo 2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Randomized Placebo-controlled Study of Aspirin and N-acetyl Cysteine as Adjunctive Treatments for Bipolar Disorder Patients (SMRI 11T-009)
Brief Summary: We propose to conduct a double-blind placebo-controlled trial with a widely available and prototypical non-steroidal anti-inflammatory agent, aspirin, and an antioxidant agent, NAC, involving symptomatic Bipolar Disorder type I and II patients having a depressive or mixed episode currently. This will be the first controlled study to test the hypothesis that aspirin and NAC, by themselves or in combination, will be beneficial in treating depression in bipolar disorder patients and in promoting mood stabilization.

Our study has the following Aims:

Aim I - Examine efficacy of aspirin in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim II - Examine efficacy of NAC in treating depression in bipolar patients in a double-blind placebo-controlled add-on design; Aim III - Examine efficacy of combined treatment with aspirin and NAC looking for synergistic, potentiating effects; Aim IV - Examine the role of markers of neuroinflammation, as possible mediators or modulators in therapeutic response in the treatment of depression in patients with Bipolar Disorder.


Options:
A: Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 0 to week 8 of the study); Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 9 to week 16 of the study); Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 0 to week 8 of the study); Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 9 to week 16 of the study)
B: Young Mania Rating Scale; Hamilton Depression Rating Scale (HAM-D), 17-item version Hamilton Rating Scale for Anxiety (HAM-A).; Clinical Global Impression Scale CGI-BP (41); Affective Morbidity Index (42)
C: Level of Depression as assessed by the HAM-D (Day 1-7)
D: Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose (Last Observation Carried Forward [LOCF] Data): Double-blind (DB) Treatment Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2)); Change From Baseline in Clinical Global Impression-Severity of Suicidality - Revised (CGI-SS-R) Scale at 24 Hours Post First Dose (LOCF Data): DB Treatment Phase (Baseline (Day 1, predose) and 24 hours first post dose (Day 2))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol Screening in an Ethnically Diverse Sample of Adolescents in Primary Care
Brief Summary: Screening youth in the primary care setting is one way to identify adolescents who may be at-risk for future alcohol problems. The current study tests the new NIAAA screening guide questions, which ask about friend and adolescent drinking, to see how well these questions work to predict subsequent alcohol use, problems, and involvement in other risk behaviors, such as sexual risk-taking and delinquency. In addition, the investigators plan to provide a brief motivational intervention for some at-risk teens and see whether alcohol use differs for those teens who receive the intervention and those teens who receive enhanced usual care. The results of this study have the potential to significantly impact the standard of care for identifying and intervening with at- risk youth in primary care settings.


Options:
A: Discontinuation of consumption of prescription drugs (one year); Reduction of consumption of prescription drugs (one year); Utilization of formal help (one year)
B: Compare the NCMIT and SCMT programs among homeless young gay and bisexual stimulant using men with respect to completion of a HBV vaccination series administered in three doses over a four-month period. (5 years)
C: Number of Times Used Alcohol (Past 3 months)
D: alcohol use (6 months); HIV risk taking (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Controlled Multicentre Trial Comparing Half-dose Photodynamic Therapy (PDT) With High-density Subthreshold Micropulse Laser Treatment in Patients With Chronic Central Serous Chorioretinopathy (CSC)
Brief Summary: Chronic central serous chorioretinopathy (CSC) is a relatively frequent eye disease that often occurs in patients in the professionally active age range. In this disease, there is pooling of fluid under the central retina (the macula). This specific form of macular degeneration can cause permanent vision loss, image distortion, loss of color and contrast vision due to this fluid under the retina. An early diagnosis and treatment may improve the visual outcome and quality of life. To date there is no international consensus on the optimal treatment of chronic CSC. Many retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in chronic CSC. Micropulse laser (ML) therapy may also be effective in this disease.

The proposed study is the first prospective randomized controlled trial in chronic CSC. In this study, participants with chronic CSC will be randomized into two treatment groups, PDT or ML treatment. The trial is a superiority study, because retrospective studies suggest that PDT treatment may be more effective than ML treatment. Therefore, PDT treatment is challenged against ML treatment.

The null hypothesis of the study is that PDT treatment is more effective than ML treatment in patients with active chronic CSC. The alternative hypothesis is that PDT treatment is not more effective than ML treatment in these patients.

Treatment success will not only be based on anatomical improvement, but also on functional endpoints, which are most important from a patient's perspective.

The study will take place in five large tertiary referral university hospitals in Europe that have extensive experience with conducting clinical trials (in Nijmegen, the Netherlands; Cologne, Germany; Leiden, the Netherlands; Oxford, United Kingdom; and Paris, France). Each of these centers has confirmed sufficient funding to conduct the research. The study will last max. 8 months per participant. Each participant will come for 5 (in the case of 1 treatment) or 7 visits (in the case of 2 treatments). Study evaluations will be mostly part of regular clinical care. The whole study will last for max. 24 months.


Options:
A: Serial changes in ETDRS letterscore (3 months)
B: BCVA in EDTRS values (24 months)
C: Absence of subretinal fluid on OCT scan (6-8 weeks after treatment)
D: Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301
Brief Summary: The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).

Secondary objectives of this study in this study population are as follows:

To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).


Options:
A: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)
B: Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 24 months); Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 36 months)
C: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)
D: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh
Brief Summary: This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.


Options:
A: successful menstrual regulation without the need for a surgical evacuation (14 days)
B: Rate of successful abortion (2 weeks after mifepristone administration)
C: Proportion of participants who would choose outside of center administration of mifepristone again (1-2 weeks); Proportion of participants who would recommend outside-of-center administration to a friend (1-2 weeks)
D: Efficacy defined as complete abortion without recourse to surgical abortion. (2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy
Brief Summary: The purpose of this study is to determine whether cognitive behaviour therapy is effective in the treatment of children and adolescents with dental anxiety. Our hypothesis is that children and adolescents who have been offered CBT shows significant better performance on outcome measures compared with patients in control group who have received treatment as usual.


Options:
A: Changes in dental anxiety (3 months and 12 months from baseline)
B: School version of the Selective Mutism Questionnaire (SSQ) (at 3, 6, 12 months)
C: Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). (Change from baseline interview results at 14 weeks); Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). (Change from baseline interview results at 3 months)
D: Pediatric Anxiety Rating Scale (After an average of 16 weeks (Post-treatment))

Answer: A