TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 2
Brief Summary: After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide \[UMEC\] \[62.5 mcg\] administered once daily via a DPI; OR UMEC \[125 mcg\] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.


Options:
A: Change From Baseline in Trough FEV1 on Day 85 (Baseline (BL) and Day 85)
B: adverse events, cardiac and ECG parameters, vital signs, lung function and clinical laboratory safety assessments (From dosing to 24hr post-dose)
C: Composite of Pharmacokinetic (PK) Parameters as a measure of systemic exposure. (PK Blood samples will be collected at Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose on Day 1 of each treatment period); Systemic exposure of FF and UMEC and VI following single inhaled doses (four inhalations) of FF/UMEC/VI 100mcg /62.5mcg /25mcg compared with FF/VI 100mcg /25mcg and UMEC/VI 62.5mcg /25mcg (PK Blood samples will be collected at Day 1 Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose.)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85 (Day 85)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Biomarkers of Orthodontic Tooth Movement With Fixed Appliances and Vibration Appliance Therapy: A Randomized Clinical Trial
Brief Summary: Currently, orthodontic treatment typically lasts approximately 2 years. There are a number of advantages for reducing the duration of treatment, including reducing the potential risk of caries, root resorption and for minimizing patient "burn out" from prolonged treatment.

While some evidence does exist that vibration may accelerate the speed of tooth movement, the biological mechanism is still unknown. Identification of specific factors involved in tooth movement that are further stimulated by vibration would help to understand the mechanisms involved as well as discover possible biologic targets which could be utilized or modified to maximize the benefits of vibration treatment.

The purpose of this study is to identify novel biological factors that are expressed in patients undergoing orthodontic tooth movement in conjunction with vibration appliance therapy.


Options:
A: Orthodontic tooth movement (incisor alignment) (2-12 months from start)
B: Overall Leveling and Alignment Time (OLAT) (This will be measured once the leveling and alignment stage of the orthodontic treatment is finished. This will be measured in days from the commencement of treatment till the final day of leveling and alignment.); Change in Leveling and Alignment Improvement Percentage (LAIP) (this outcome will be measured after one month (T1) and two months (T2) of treatment commencement (T0), and at the end of leveling and alignment stage (T3) using Little irregularity index (LII))
C: Changes in the Expression of Salivary Biomarkers of Bone Remodeling (Up to Week 17 of alignment (From T0 to T3)); Alignment of Mandibular Anterior Teeth (Up to Week 17)
D: Duration of fixed appliance orthodontic treatment (Completion of orthodontic treatment, an expected average of 24 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life
Brief Summary: This is a study to determine the effectiveness of a Group Therapy that provides psycho-education and support for caregivers of cancer patients. Caregivers must be between 21 and 64 years of age and be willing to attend a one-hour a week program for four weeks. The sessions will be in English, and a set of questionnaires (demographic data, some information about your family member with cancer, and scales: Caregiver Quality of Life-Cancer Scale (CQOLC), Perceived Stress Scale and the Hospital Anxiety Depression Scale (HADS)) will be completed at the start, at 4 weeks, at 8 weeks and at 12 weeks. Some participants placed on a wait-list to start the Group Therapy 4 weeks later will also complete the set of questionnaires at this point. A Feedback and Satisfaction Questionnaire will be completed at the end of the 4 week program. In addition, at the end of the 4 week program, some participants will go through a 15-minute interview.


Options:
A: Change in Quality of Life (Baseline, 3 and 6 months)
B: Self-efficacy in symptom management (One month)
C: Change in Impact of Event Scale (IES) (Baseline, 2 weeks post-intervention, 10 months follow-up); Change in The Hospital Anxiety and Depression Scale (HADS) (Baseline, 2 weeks post-intervention, 10 months follow-up); Change in The Profile of Mood States - Short Form (POMS-SF) (Baseline, 2 weeks post-intervention, 10 months follow-up)
D: Caregiver Quality of Life Index - Cancer (4 weeks); Perceived Stress Scale (4 weeks); Hospital Anxiety and Depression Scale (4 weeks); Basic Psychological Needs Scale (4 weeks); Healthcare Climate Questionnaire (4 weeks); Perceived Competence Scale (4 weeks); Interpersonal Support Evaluation List (4 weeks); Benefit Finding (4 weeks); Satisfaction and Feedback Questionnaire (4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants
Brief Summary: The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC). As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered peer counseling. Little is known as to the effectiveness of these peer counseling programs. Randomized controlled trials of peer counseling interventions among low-income women in the U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the level of support provided could be scaled up to service WIC clients nationally. The investigators tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation, duration and exclusivity.


Options:
A: Newborn survival (to 28 days) (July 2010 to June 2013)
B: proportion of patients with breastfeeding completed at 6 months (6 months)
C: Exclusive breastfeeding (6 months postpartum)
D: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants
Brief Summary: The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC). As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered peer counseling. Little is known as to the effectiveness of these peer counseling programs. Randomized controlled trials of peer counseling interventions among low-income women in the U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the level of support provided could be scaled up to service WIC clients nationally. The investigators tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation, duration and exclusivity.


Options:
A: Change in target behaviour: zinc use (six weeks post-intervention); Change in target behaviour: correct ORS preparation (six weeks post-intervention); Change in target behaviour: Exclusive breastfeeding (six weeks post-intervention); Change in target behaviour: Handwashing with soap (six weeks post-intervention)
B: Exclusive breastfeeding (at six month)
C: Exclusive breastfeeding (6 months postpartum)
D: Breastfeeding at 3 months and at 6 months (3 months and six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants
Brief Summary: The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC). As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered peer counseling. Little is known as to the effectiveness of these peer counseling programs. Randomized controlled trials of peer counseling interventions among low-income women in the U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the level of support provided could be scaled up to service WIC clients nationally. The investigators tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation, duration and exclusivity.


Options:
A: Exclusive breastfeeding (6 months postpartum)
B: Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery); Change in number of minutes spent on stress management each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery); Change in number of servings of fruits and vegetables consumed each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery)
C: Contraceptive knowledge score (1 year)
D: Exhaled Carbon Monoxide Levels (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants
Brief Summary: The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC). As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered peer counseling. Little is known as to the effectiveness of these peer counseling programs. Randomized controlled trials of peer counseling interventions among low-income women in the U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the level of support provided could be scaled up to service WIC clients nationally. The investigators tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation, duration and exclusivity.


Options:
A: Breastfeeding at 3 months and at 6 months (3 months and six months)
B: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
C: Exclusive breastfeeding (6 months postpartum)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants
Brief Summary: The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC). As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered peer counseling. Little is known as to the effectiveness of these peer counseling programs. Randomized controlled trials of peer counseling interventions among low-income women in the U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the level of support provided could be scaled up to service WIC clients nationally. The investigators tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation, duration and exclusivity.


Options:
A: Exclusive breastfeeding (6 months postpartum)
B: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)
C: Receipt of 2nd Dose of the Influenza Vaccine. (by April 30th after receipt of first dose (up to 8 months))
D: MV Coverage at 12 months of age (12 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy
Brief Summary: Malnutrition during pregnancy is more common in poor women in the developing world due to inadequate dietary intake combined with increased nutrient requirements; pregnancy risk is more consequential than among other demographic groups with increased risk of maternal and infant mortality and the lifelong effects of fetal malnutrition. The benefits of treating moderate malnutrition during pregnancy remain largely undocumented. This study tests the hypothesis that providing either a fortified flour or fortified paste-based supplementary food designed to replete the nutrient deficits during pregnancy will result in improved maternal nutritional recovery rates and higher infant birth weights and lengths. This study is a randomized, controlled clinical trial of 3 supplementary foods in 1800 moderately malnourished Malawian women who are pregnant. Subjects will receive one of 3 food rations: 1) a ready-to-use supplementary food formulated to deliver about 200% of the recommended daily allowance (RDA) of most micronutrients in pregnancy (RUSF-P), 2) corn soy blend with a multiple micronutrient tablet chosen to deliver about 200% of the RDA of most micronutrients (CSB-P) or 3), the standard of care which is a corn soy blend with supplementary iron and folic acid (CSB), delivering between 0-350% of the RDA. Subjects will receive the supplementary food until they recover from MAM. The outcome of the pregnancy and maternal nutritional status will be followed until 3 months after delivery.


Options:
A: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)
B: Plasma zinc concentration (1 month)
C: Proportion recovered from moderate acute malnutrition (MAM) (up to 40 weeks); Maternal change in mid-upper arm circumference (MUAC) (up to 40 weeks); infant birth weight (up to 40 weeks); infant birth length (up to 40 weeks); premature delivery (up to 36 weeks)
D: Mean birth weight (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients
Brief Summary: Forty patients will be assigned to either a training group (12 wk unilateral knee extension flywheel resistance exercise; 4 sets of 7 reps 2 days/week) or a control group. Patients will maintain daily routines and any prescribed rehabilitation program. Established methods to assess muscle and cognitive function will be employed before and after the intervention.

This project will disclose whether an exercise paradigm, known to improve muscle function and increase muscle volume in healthy populations, will induce similar adaptations in chronic stroke patients. More importantly, this study will elucidate if any impairment in cognitive function caused by stroke, can be reversed with this particular resistance exercise regimen.

The information gained from this project will have significant implications and aid in advancing rehabilitation programs and exercise prescriptions for men and women suffering from stroke. The overall objective of this research is to promote independence and hence quality of life in these patients.


Options:
A: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))
B: The number of steps taken per day by participants in each group (at baseline & at 6 weeks post randomisation)
C: Change from baseline in Cognitive Function at 3 months (Baseline, Month 3); Change from baseline in Functional Performance at 3 months (Baseline, Month 3); Change from baseline in Muscle Function at 3 months (Baseline, Month 3)
D: Change in Peak Endpoint Reaching Velocity (Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)); Change in Reaching Work Area (Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuous Adductor Canal Block With Epidural Analgesia for Total Knee Arthroplasty: A Prospective, Randomized, Double-blinded, Placebo-Controlled Trial
Brief Summary: The purpose of this study is to further investigate the efficacy of adductor canal nerve blocks for pain management after total knee replacement. Specifically we are studying adductor canal nerve blocks in conjunction with epidural anesthesia, which is a combination that has not been extensively researched before. Our question is whether combining these modalities will enhance patient satisfaction after surgery and accelerate patients' readiness to discharge.


Options:
A: Morphine Equivalents (12 hours postoperatively and 20 hours after placement of catheter)
B: Pain scores (3 days postoperative)
C: Pain (Average): Numeric Rating Scale for Pain (Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal))
D: Timed Up and Go test (2-3 days post srugery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Project of the South Florida Center for Reducing Cancer Disparities (SUCCESS): Testing CHWs and HPV Self-Sampling to Increase Cervical Cancer Screening Among Minority Immigrants in Miami-Dade County:
Brief Summary: Caribbean immigrants (both Hispanics and Blacks from Haiti) are less likely to be screened for cervical cancer than the general population. One promising approach is outreach strategies that employ Community Health Workers (CHWs). Yet even in well structured CHW programs, many women remain unscreened. In our NCI Community Networks sponsored project, we are testing an approach that combines CHWs with self sampling for the human papilloma virus (HPV) as a screening strategy among such hard to reach populations.


Options:
A: Having had a pap smear in last 6 months (6 months)
B: Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) (same day as HIV test counseling (cross-sectional study))
C: Change in HIV viral suppression (Assessed at 4 month follow up (FU), 12 month FU)
D: New Advance Care Planning Documentation in the Medical Record at 15 Months (15 months after study enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Teledermatology Versus Usual Care on Delay Before Diagnosis and/or Treatment of Dermatologic Conditions in General Practice
Brief Summary: In France, there is usually a long delay (approximately 6 weeks) before a general practitioner can obtain a specialized advice by dermatologists for diagnosis of "unusual" dermatologic conditions of their patients.

Previous studies have shown that teledermatology is a reliable way for diagnosis in dermatology.

We hypothesize that a teledermatology advice could reduce delay before diagnosis and therefore treatment for patients.


Options:
A: Delay before expertise by a dermatologist (3 months)
B: Changes in mean SBP (From baseline (T1) to 12 months (T3))
C: Safety and quality of health care (1 year)
D: Intervention-related adverse events (1 day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Home-monitoring in the Adherence of Patients With Chronic Obstructive Pulmonary Disease to Long-term Rehabilitation
Brief Summary: The aim of this randomized controlled trial is to investigate the effects of adding PA monitoring and regular feedback of a pedometer (step counter) to an outpatient pulmonary rehabilitation (PR) program on daily PA levels and health status of patients with COPD.

Patients will be randomized to either receive a PR program with PA monitoring and regular feedback of a pedometer (experimental group \[EG\]) or a PR program alone (control group \[CG\]). During the PR program, patients in the EG will receive a pedometer to self-monitor their PA and individualized step-count goals. They will continue to use the pedometers and receive individualized goals for 3 months after the program.

It is expected that, by receiving individualized goals and a simple pedometer to self-monitor their PA during and after a PR program, patients with COPD will become more active and adhere to long-term rehabilitation, thus reducing the overall impact of COPD.


Options:
A: Change in Health Related quality-of-life: St. George Respiratory Questionnaire (Up to 9 months)
B: Change in physical activity levels (1 week before, 1 week after, 3 and 6 months after the PR program)
C: Physical activity in daily life (measuremet unit: number of steps per day) (four years)
D: Exercise behavior (3 & 6 Months)

Answer: B