TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Exercise Improve Cancer Associated Cognitive Dysfunction?
Brief Summary: Following chemotherapy, some breast cancer survivors report alterations in their ability to remember, concentrate, or think, which can have significant emotional, psychological, and economic impact on their lives. Survivors have also reported feeling frustrated by the response of the medical community, who either may not acknowledge their symptoms or have no treatment options to suggest. Exercise may be a promising treatment, as improvements in cognitive function with exercise have been demonstrated in older adults and other clinical populations.

The investigators will recruit women who have completed chemotherapy for breast cancer (within the past 2 years) and report cognitive changes. Women will be randomly assigned to either a 24-week aerobic exercise intervention or delayed exercise control (offered the same exercise program following the study). At the start and end of the study the investigators will measure: i) performance on four standard neuropsychological tests that measure working memory, learning, and problem solving; ii) a questionnaire on cognitive function and its impact on quality of life; iii) functional magnetic resonance imaging (fMRI) during two of the standard neuropsychological tests which provides information on how the brain is working during the tests.

To knowledge of the investigators this is the first study to examine the effect of an exercise intervention on cognitive function in breast cancer survivors. In addition, the use of fMRI imaging is a new way to approach this research question, and may be more sensitive to change than traditional measures of cognitive function.


Options:
A: Stroop Test (Change from baseline at 6 months)
B: Change in cognitive composite score (baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training))
C: Progression-free-survival (6 months)
D: Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks (Baseline and 24 weeks from the start of drug treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Population Versus Practice-based Interventions to Increase Immunizations
Brief Summary: One of the nation's major health priorities, as outlined in Healthy People 2010, is to increase the proportion of children aged 19 to 35 months who have received all universally recommended vaccines. This study will compare two interventions for increasing immunization rates in this age group, one using well-studied primary care practice-based methods and the other using innovative technologies to increase immunization rates at the population-level. Results of this study will provide data that will be relevant nationally in guiding future investment of resources to increase up-to-date rates in young children prior to school entry.

Hypothesis: Population-based approaches will be more effective than practice-based interventions at increasing immunizations among 19-35 month olds.


Options:
A: self-reported status of the series of HBV vaccinations by follow-up calls in seven months after mailing the results verified by the medical records (Seven months after mailing the results)
B: Evaluate effectiveness of population-based reminder/recall methods versus practice-based reminder/recall methods in 14 Colorado counties (rural and urban) (6 months post-intervention (December 2010))
C: seasonal influenza vaccination (up to 4 months following reminder notification)
D: Receipt of 2nd Dose of the Influenza Vaccine. (by April 30th after receipt of first dose (up to 8 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: I-care: Stimulating Self-management in Patients With Type 2-diabetes Through Web-based Situational Feedback. A Pilot Study.
Brief Summary: The overall objective of this pilot study is to develop a cost-effective treatment methodology delivered outside of traditional clinical setting, and based on modern technology for patients with diabetes type 2 also suffering from obesity. This study will investigate the feasibility of web based counselling and situational feedback through mobile supervising. The intention is to treat 10-15 patients. All participants will receive standard treatment delivered by their general practitioners. In addition the participants will fill in and send diaries to the supervisors each evening for 4 weeks reduced to a weekly frequency for the next two months period. The diary's schedule will be an evaluation of the day activities related to meals and food, medication management as well as the performed physical activities. The diary's schedule will also include blood glucose sample, and plans for the next day especially regarding physical activity. The participants will be able to view their own registrations on a web page. Daily/weekly situational feedback will be given to the participants within a cognitive behavioural framework to stimulate self-management. The primary outcome will be the HbA1c levels. Secondary outcomes will include evaluation of lifestyle outcomes such as physical activity levels and eating behaviour, and skills such as self-management of medication. In addition, the interventions effectiveness will examine mental health outcomes such as emotional distress and health-related quality of life.


Options:
A: Blood glucose control with changes in Glycated hemoglobin (HbA1c) values (At the baseline and at the end of the intervention (3 months))
B: Blood Pressure (one year)
C: healing time for leg ulcer and/or diabetes related foot ulcer (one year)
D: Satisfaction with the health coach intervention as assessed by surveys (From enrollment until the end of the intervention at 36 weeks of gestation.); Satisfaction with the health coach intervention as assessed by phone interviews (From enrollment until the end of the intervention at 36 weeks of gestation.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial
Brief Summary: The aim of this project is to motivate and support general practice clinics in implementing the visions and recommendations presented in two of the disease specific programmes for chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These programmes describe evidence based treatment and division of tasks between the municipalities, the hospitals and general practice.

The Facilitator Project is funded by The Danish Ministry of Interior and Health.


Options:
A: Change from baseline at 12 month in Annual systematic chronic disease follow up consultations (Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention))
B: Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later. (1-2 months before the intervention and 18 months after the intervention); Difference in questionnaire about knowledge in COPD (questionnaire created by the research group)among the general practitioners that receive the education. (Immediately before the intervention and 12 months later.)
C: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)
D: Characterize COPD Disease Severity in Clinical Practice (2 years); Characterize COPD Disease Activity in Clinical Practice (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial
Brief Summary: The aim of this project is to motivate and support general practice clinics in implementing the visions and recommendations presented in two of the disease specific programmes for chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These programmes describe evidence based treatment and division of tasks between the municipalities, the hospitals and general practice.

The Facilitator Project is funded by The Danish Ministry of Interior and Health.


Options:
A: Health-Related quality of life (12 months)
B: inflammatory cytokines (6 months); C-reactive protein (CRP) (6 months); Incremental shuttle walk test (ISWT) (6 months); spirometry (6 months); strength of limb muscles (6 months)
C: Change from baseline at 12 month in Annual systematic chronic disease follow up consultations (Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention))
D: Hospital Readmission (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Single-Center, Phase 1 Clinical Study to Evaluate the Safety and the Efficacy of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia
Brief Summary: PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended to treat premature infants with bronchopulmonary dysplasia. This study is to assess the safety and the efficacy of this study drug.


Options:
A: Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. (during infusions: first 18 postnatal days)
B: Neurodevelopmental outcomes (6 months); EEG changes (2-3 weeks); MRI of the brain (3 weeks)
C: Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs) (One month post-catheterization)
D: Number of participant with adverse reaction (12 weeks from the day of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Label, Single-Center, Phase 1 Clinical Study to Evaluate the Safety and the Efficacy of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia
Brief Summary: PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended to treat premature infants with bronchopulmonary dysplasia. This study is to assess the safety and the efficacy of this study drug.


Options:
A: Number of participant with adverse reaction (12 weeks from the day of treatment)
B: Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. (during infusions: first 18 postnatal days)
C: Number of subjects with Adverse Drug Reaction (at corrected age of 21 months (±3 months))
D: Neonatal Behavioral Neurological Assessment (14days after birth); number of adverse events (7days after cell or factor injection); Neonatal Behavioral Neurological Assessment (28days after birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial Phase III, Parallel Group, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab Administration in Patients With Moderate-to-severe or Sight-threatening Graves' Ophthalmopathy (GO), That Had Not Responded Adequately to Treatment With Intravenous Corticoid Pulses.
Brief Summary: The purpose is to investigate tocilizumab administration in patients with moderately to severely or sight-threatening GO (Graves' ophthalmopathy) without response to treatment with corticoid intravenous pulses. Currently, these patients only have surgery as therapeutic alternative.

The principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment in order to provide a better alternative to surgery for this patients.


Options:
A: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year (When all participants complete the 1 year visit)
B: Change in Clinical Activity Score (CAS) (baseline, 6 months after the first infusion)
C: Drug efficacy will be established as a decrease in CAS (clinical activity score) by 2 or more points in a scale of 10. (It will be measured before treatment (week -4 / 0), after treatment (week 16) and after the end of the follow-up (week 40).)
D: Responder Status at Week 24 (Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre Randomised Clinical Trial of Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema
Brief Summary: The specific aims of the study are to test the following hypotheses:

* That there is a difference in change in visual acuity resulting from treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced macular oedema
* That there is a difference in degree of resolution of macular oedema resulting from treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced macular oedema
* That both intravitreal bevacizumab and dexamethasone implants have a manageable and acceptable safety profile in eyes with diabetic macular oedema


Options:
A: visual acuity; central macular thickness
B: Mean Change in Visual Acuity Letter Score (24 weeks after randomization)
C: Visual acuity; Central macular thickness
D: Visual acuity gain (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre Randomised Clinical Trial of Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema
Brief Summary: The specific aims of the study are to test the following hypotheses:

* That there is a difference in change in visual acuity resulting from treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced macular oedema
* That there is a difference in degree of resolution of macular oedema resulting from treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced macular oedema
* That both intravitreal bevacizumab and dexamethasone implants have a manageable and acceptable safety profile in eyes with diabetic macular oedema


Options:
A: Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks (baseline to 14 weeks)
B: Visual acuity gain (2 years)
C: diffuse macular oedema (1, 3 and 6 months)
D: Visual Acuity (36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles
Brief Summary: The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and medications are delivered locally. It has been proven to be as safe and effective as the combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. Following a single vaginal insertion, steroid concentrations remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to better compliance, tolerability and acceptance by patients requiring ovarian suppression prior to COH for IVF.


Options:
A: live birth rate (10 months for group A, 12 months for group B)
B: Implantation rate (20 days after the embryo transfer)
C: Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description) (patients were followed for the duration of an in-vitro fertilization cycle- 2 months)
D: clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity (12 weeks after embryo transfer)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ankle Tracking Training in Stroke
Brief Summary: The purpose of this study is to compare the improvement in ankle control and brain activation in subjects with stroke resulting from two different forms of telerehabilitation: tracking training, emphasizing accurate movements, versus movement training, involving simple movements.

Hypotheses:

1. The Track group will show greater improvement in ankle range of motion compared to the Move group.
2. The Track group will show greater improvement in ankle tracking accuracy and greater changes in fMRI (increase in relative volume of activation for ipsilesional sensorimotor cortex, increase in laterality index, and decrease in blood-oxygen-level-dependent (BOLD) signal intensity index) compared to Move group.
3. The Track group will show greater improvement in tracking accuracy at an untrained joint (knee) compared to the Move group.
4. The Track group will show greater improvement in standing balance.
5. The Track group will show greater improvement in walking speed and ankle dorsiflexion during gait compared to the Move group.


Options:
A: Wolf Motor Function Test (0 to 1 months); Motor Activity Log Quality of Movement Scale (0 to 1 months)
B: Naming ability assessed by NGA (four month post randomization)
C: Physical Function as Measured by Telephone Version of FIM (6-month)
D: ankle range of motion (Measurement at pretest, posttest and followup)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency
Brief Summary: Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.

The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.


Options:
A: cumulative probability of recurrent varicose vein within 24 months after treatment (24 months)
B: anatomical success rate (absence or obliteration of GSV on US examination) (3 months, 1 and 5 years)
C: Recanalization or reflux of the treated venous trunk (at 1 and 12 months)
D: Change in intensity of hyper pigmentation using a scale of 0 to 10 (One week, one month and six months after surgery); Change in extension of hematoma using a scale of 0 to 10 (One week, one month and six months after surgery); Change in aesthetic results using a scale of 0 to 10 (One week, one month and six months after surgery); Change in pain levels using a scale of 0 to 10 (One week, one month and six months after surgery); Change in intensity of skin burns using a scale of 0 to 10 (One week, one month and six months after surgery); Change in presence of sensitivity alteration (One week, one month and six months after surgery); Change in presence of thrombophlebitis (One week, one month and six months after surgery); Change in presence of resection or occlusion of the great saphenous vein (One month, six months and 12 months after surgery); Change in presence of reflux in the sapheno-femoral junction and in the great saphenous vein (One month, six months and 12 months after surgery); Change in presence of complications (One month, six months and 12 months after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions
Brief Summary: The objective of this study is to evaluate the safety and efficacy of preparing a vessel with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation


Options:
A: Late lumen loss (6 months)
B: Angiographic Binary Restenosis (6 months)
C: Target Lesion Percent Stenosis (at 1 Year)
D: Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA) (12 months or at Target Lesion Revascularization (TLR) time); Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients (12 months); Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Steps to Health: Targeting Obesity in the Health Care Workplace
Brief Summary: The proposal of this study is to compare the effectiveness of two worksite weight management programs at Duke: Steps to Health (STH) ('usual standard of care') and the more extensive Steps to Health Plus! (STH+). We have added an additional follow-up, by invitation only, for participants in the study who agreed to be contacted for future research.


Options:
A: Quit Rate (30-day Follow-Up); Quit Rate (6-Month Follow-Up)
B: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
C: Weight loss (~1-2 years post baseline)
D: change in physical activity (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy
Brief Summary: In the proposed study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal contraceptive implant. Over a 24 month period, the experiences of LARC users will be compared to the experiences of those opting for their initial short-acting method.


Options:
A: Continuation Rates of the LNG-IUS when placed postpartum at three time periods (at 6 months)
B: Contraceptive Method Discontinuation (24 months)
C: Expulsion rate (6 months); The percentage of females seeking contraception (6 months)
D: neonatal growth (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis
Brief Summary: The investigators hypothesise that long term statin treatment will improve patients' symptoms through its anti-inflammatory effect. The beneficial effects on patient symptoms (cough, sputum volume, bacterial load, airway function, exercise tolerance, exacerbation frequency and health related quality of life) will be consequent on reduced neutrophilic airways inflammation.


Options:
A: Rate of Graded Pulmonary Exacerbations (52 weeks)
B: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
C: The primary endpoint of this study is a reduction in cough at 6 months compared to baseline as measured by the Leicester Cough Questionnaire score. (6 months)
D: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaginal Dilators for Prevention of De Novo Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial
Brief Summary: This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with traditional posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4 through week 8 after posterior repair will reduce the rate of de novo dyspareunia.


Options:
A: To compare rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with posterior repair (colporrhaphy). (6 months)
B: Pain While Active - 18 hr (18 hours); Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery (24 hours)
C: The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40). (up to 20-24 hours after surgery)
D: Surgeon assessment of bowel preparation (Will be evaluated at 1 year)

Answer: A