TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: College Students Who Self-Harm: An Intervention Study
Brief Summary: Study Aims/Objectives:

This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to the unique requirements of students meeting sub-clinical diagnostic criteria for BPD (Borderline Personality Disorder) with its associated high rate of self-harm and suicide.


Options:
A: Change in BPD (Borderline Personality Disorder) behaviors (8-weeks)
B: Columbia Suicide Severity Rating Scale Number of Participants Reporting Presence of Suicidal Behaviors (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Columbia Suicide Severity Rating Scale Number of Suicidal Behaviors (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); The Number of Participants Reporting Columbia Suicide Severity Rating Scale Suicidal Ideation Categories as Most Severe (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Columbia Suicide Severity Rating Scale Suicidal Ideation Intensity Scale Total Score (Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.); Number of Participants With Readmissions (Assessed on a monthly basis for 6 months follow-up.)
C: suicide/attempted suicide (12 months)
D: Repeat Suicide Attempts (1, 2, and 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: College Students Who Self-Harm: An Intervention Study
Brief Summary: Study Aims/Objectives:

This projects' Primary Aim is development of a Condensed DBT Stepped Care Model tailored to the unique requirements of students meeting sub-clinical diagnostic criteria for BPD (Borderline Personality Disorder) with its associated high rate of self-harm and suicide.


Options:
A: Change in BPD (Borderline Personality Disorder) behaviors (8-weeks)
B: Change in Autonomous and Controlled Motivation (From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months))
C: Delay of recurrence of suicide attempt (6 months)
D: Re-presentation to hospital with suicide attempt and/or suicidal ideations (7 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (14 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (30 days post intervention); Re-presentation to hospital with suicide attempt and/or suicidal ideations (90 days post intervention); Death by suicide rates (24 months post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OptiTrain - Optimal Training for Women With Breast Cancer During Chemotherapy Treatment
Brief Summary: This study on women with breast cancer during and after chemo- and hormonal therapy compares the effect of different physical training programs on physical and mental well-being and systemic inflammation mechanisms in blood. In a sub-group of participants, mitochondrial biogenesis and function and other molecular processes in skeletal muscle biopsies are studied. The women will be randomly allocated into three different intervention arms, a control arm with usual care and two different training arms. All participants will respond to questionnaires and have blood samples and taken and for a subgroup muscle biopsies before and after the exercise intervention. Participants will be supported to uphold exercise through collaboration with Friskis \& Svettis and followed for 5 years. Some of the women will also be asked to participate in an in depth interview about the experiences of exercise during ongoing treatment. This study will contribute to increased knowledge about the type, intensity and frequency of training that patients with breast cancer benefit most from with regards to impact on physical and mental wellbeing. This knowledge is of great importance since experience shows that patients and relatives often seek information about rehabilitation, self-care and physical activity. The study will also contribute to the improvement of the patients´ quality of life, ability to return to work, and reduce social costs, but above all, increase the possibility for development and implementation of evidence-based rehabilitation of women with breast cancer during and after active treatment.


Options:
A: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)
B: Cancer related fatigue (Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline)
C: Breast Cancer Recurrence (Lifetime)
D: Bone mass-lumbar spine and hip (DEXA) (baseline, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)
Brief Summary: A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.


Options:
A: Early graft injury (During the first week postoperatively (absolute and relative delta))
B: major complications after liver transplantation (During the first year postoperatively)
C: Participants With Early Liver Allograft Dysfunction (EAD) (7 days); Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient (30 days)
D: The incidence of symptomatic non-anastomotic biliary strictures (NAS) (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Catheter Location on Postoperative Analgesia for Continuous Adductor Canal and Popliteal-Sciatic Nerve Blocks
Brief Summary: Currently, continuous adductor canal and popliteal-sciatic nerve blocks are used commonly for lower extremity post-operative pain control, specifically for total knee arthroplasty and foot/ankle surgery, respectively. A perineural catheter used to infuse local anesthetic for postoperative analgesia may be placed at various locations along the target nerves. Investigations of single-injection peripheral nerve blocks suggest that the onset of the block might be faster with one location over the other; but, the success rates are equivalent. However, remaining unknown is whether there is an optimal location to place a perineural catheter as part of a continuous peripheral nerve block.


Options:
A: Pain during 45 degrees active flexion of the knee (4 hours postoperative)
B: The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block (24 h postoperatively)
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: Quadriceps muscle strength (MVIC) difference between the ACB and FNB after total knee arthroplasty. (Baseline, 6, 24, 48 hours and at 6 month after nerve block performance)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Mechanical thrombectomy (TM) is now validated through 4 randomized controlled trials of high scientific level as the reference treatment of cerebral infarction associated with proximal cerebral occlusion (MR CLEAN, ESCAPE 2014, 2015). These studies have shown for the first time a major decrease (-35%) of disability related to severe cerebral infarction and reduction in mortality. These studies only used thrombectomy devices called stent retriever for obtaining recanalization rates ranging from 58-72% for the 2 largest studies (MR CLEAN, ESCAPE 2014, 2015). This criterion "recanalization" is important because it largely determines the functional prognosis of patients with severe cerebral infarction (Khatri, 2014).

These results are exciting but we can do even better. Indeed, already new thrombectomy devices are available with a special interest for ADAPT (A Direct Aspiration First Pass Technic). This distal suction system, with a high level of endovascular navigability, provides high recanalization rates (\> 90%), low morbidity, with a synergistic effect with stent retriever (Turk A, Kowoll 2014 and 2015). To date, these technic (ADAPT) has never been assessed in a randomized controlled trial.

We have previously conducted a comparative observational study between two recanalization strategies by thrombectomy using first-line ADAPT or the most widely used stent retriever. The interventional neuroradiologist could, in case of recanalization failure with the Solitaire system, used another thrombectomy material left to the operator's choice. 244 consecutive patients on two centers (Rothschild Foundation, and Foch Hospital, France) admitted for a cerebral infarction associated with proximal occlusion were included. This is so far the largest series of patients with ADAPT system. The complete recanalization rate was 84% with ADAPT versus 68% with stent retriever (P = 0.006). Unpublished data, Oral presentation at the European Stroke Organization, April 2015). Our research aims to show that a first line strategy of recanalization by thrombectomy using a distal suction system (ADAPT) is superior that the use of a stent retriever.


Options:
A: Complete recanalization percentage (Immediately after the revascularization procedure is completed)
B: Number of Participants With Angiographic Revascularization of the Occluded Target Vessel (At immediate post-procedure); Number of Device-related Serious Adverse Events (Within 24 hours post-procedure); Number of Procedure-related Serious Adverse Event (Within 24 hours post-procedure)
C: modified Rankin Scale (mRS) (at 90 days from randomization)
D: Composite of Subsequent Stroke or Death (From randomisation (day 1) to visit 3 (day 30-34))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Applying Telemedicine Technologies in a Novel Model of Organizing and Implementing Comprehensive Cardiac Rehabilitation in Heart Failure Patients - TELEREH-HF
Brief Summary: Applying modern technology of data collecting, monitoring, transmitting and analyzing in order to implement a novel (hybrid) model of comprehensive home-based cardiac rehabilitation in heart failure patients.


Options:
A: Effectiveness measured by exercise testing and control of cardiovascular risk factors (During 12 months)
B: days alive and out of hospital (up to 2 years)
C: Health related quality of life (12 months); HbA1c change over time (participants with T2DM only) (12 months)
D: Change in the levels of physical fitness (Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain
Brief Summary: Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. This randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in VA patients with chronic low back pain. Although not every VA patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many VA patients. If yoga is effective, it could become an additional low-cost option that the VA can offer to better serve Veterans with chronic low back pain.


Options:
A: Selfrated function, symptoms and pain-rating (8 weeks, 6 month, 12 month)
B: Pain Intensity (5 weeks after randomization); Disability (Five weeks after randomization)
C: Roland-Morris Disability Questionnaire (baseline to 12 weeks); Roland-Morris Disability Questionnaire (baseline to 6-months)
D: Change from Baseline in Average Pain intensity in previous week (12 wks); Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability (12 wks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain
Brief Summary: Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. This randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in VA patients with chronic low back pain. Although not every VA patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many VA patients. If yoga is effective, it could become an additional low-cost option that the VA can offer to better serve Veterans with chronic low back pain.


Options:
A: Number of Days on Sick Leave (12 MONTHS)
B: Client Satisfaction Questionnaire (3 months); Credibility Expectancy Questionnaire (CEQ) (1 month); Participant adherence (3 months); Participant homework adherence (3 months); Instructor manual fidelity checklist (3 months); Systematic Assessment of Treatment-Emergent Events - General Inquiry (3 months)
C: Change from Baseline in Average Pain intensity in previous week (12 wks); Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability (12 wks)
D: Roland-Morris Disability Questionnaire (baseline to 12 weeks); Roland-Morris Disability Questionnaire (baseline to 6-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparative Study of Mefloquine and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant Human Immunodeficiency Virus Positive Patients
Brief Summary: Randomized controlled single blind prospective comparative study.


Options:
A: Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
B: Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis for malaria in pregnancy (6 months)
C: Trial 1 (IPTp MQ vs IPTp SP): Low birth weight. (day 0, birth); Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia. (day 0, delivery)
D: Maternal malaria at delivery (Delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
Brief Summary: To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis


Options:
A: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (Baseline up to the end of study (up to Day 78))
B: Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16 (Baseline to Week 16)
C: Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12 (Baseline (Day 1) and Week 12)
D: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 (Baseline (pre-dose on Day 1) and Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Intermittent Fasting and Caloric Restriction on Total and Regional Body Composition, Cardiometabolic, Oxidative Stress & Plasma Toxin Biomarkers, and Energy Metabolism in Overweight/Obese Men and Women
Brief Summary: This study systematically quantified the effects of intermittent fasting and caloric restriction (IFCR) on total and regional (abdominal) body composition (lean mass and fat mass), blood lipids, toxins, oxidative stress biomarkers, energy expenditure, and substrate utilization in 43 overweight/obese middle-aged men (n=22) and women (n=21). Participants were enrolled in the study as a single cohort and participated in an 12-week trial consisting of two consecutive phases: 1) 1-week baseline, weight maintenance control phase (C), and 2) 11-week weight loss IFCR phase. During the 1 week C phase, volunteers were required to maintain their body weight by consuming their normal food intake; however, during the 11 week IFCR, subjects were instructed to consume 75% of their normal intake to result in a 1-2 lb of body weight loss per week. At the conclusion of the 12 week weight loss study, all 40 participants (3 drop-outs) were invited to enroll in a 12 month follow up study. If they agreed to participate, groups were balanced so there were similar numbers of men and women and were weight-matched. The two groups (n=37, 3 dropped prior to allocation) included: 1) a modified version of the 12 week weight loss intervention that consumes whole foods along with 2 meal replacements (rather than 3) (MR; n=19) or 2) a whole foods diet similar to the Therapeutic Lifestyle Changes diet recommended by the National Institute of Health (TLC, n= 18) and asked to follow these nutritional guidelines ad libitum for the duration of 12 months.


Options:
A: Measure of plasma glucose (5 weeks)
B: Change in Total Body Fat, kg (Baseline, 12 week, 64 weeks)
C: Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months (Every 6 months- baseline, 6 month and 12 month)
D: Change in Glucose Tolerance (Before and after 5 weeks on each feeding schedule)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Mild Hypothermia and Machine Perfusion in Deceased Organ Donors for Protection Against Delayed Graft Function in Kidney Transplant Recipients
Brief Summary: To protect kidney function during the transplantation process by comparing mild hypothermia in the deceased organ donor before organs are recovered and pulsatile perfusion of the kidney after recovery and prior to transplantation.


Options:
A: Delayed graft function (Within one week posttransplantation)
B: Rate of graft loss (at 6 months postoperatively); Rate of Ischemic Type Biliary Lesions (ITBL) (at 6 months postoperatively)
C: The rate of Delayed graft function (the first week after transplant)
D: Delayed Graft Function in Kidney Allografts (7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This evaluation is part of a five country project to evaluate the benefits and costs of the use of two alternatives to food transfers: vouchers and cash (hereafter referred to as "alternative modalities"). The project will generate information on how outcomes such as household food expenditure and dietary diversity, relevant to both beneficiaries and WFP, change following the introduction of these alternative modalities; how benefits and costs of these are, relative to food transfers, distributed across and within households; and what are the critical operational issues that need to be addressed for these alternatives to be successfully implemented. More specifically, the project will answer seven questions:

1. Do households benefit from receipt of the alternative modalities?
2. Are these benefits greater, or less, when transfers are made using alternative modalities compared to food transfers. How does this vary across outcomes (such as nutrition, livelihoods, gender dynamics and intra-household resource allocation) that are of especial interest to WFP?
3. How does the distribution of benefits differ across households when transfers are made using alternative modalities compared to food transfers?
4. How does the distribution of benefits differ within households when transfers are made using alternative modalities compared to food transfers? Do certain household members (women, young children) benefit more from one type of modality? How do these modalities affect decision-making processes within the household?
5. Why are these differences observed? How do the reasons for these differences affect the study's ability to generalize from these evaluations?
6. Does the delivery of alternative modalities cost less than food transfers? What accounts for these cost differences? Are some costs (such as transport) really lower or are they transferred to beneficiaries? Within the household, who bears these additional costs?
7. What is the benefit: cost ratios associated with these different modalities from the perspective of WFP? Is there a conflict between the modality "preferred" by WFP and the modality "preferred" by beneficiaries?

These objectives will be accomplished through household survey data collection among a panel of households before and after transfer of alternative modalities. In addition, select countries will involve the collection of anthropometric, biomarker and cognitive testing.


Options:
A: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)
B: Child nutritional status
C: Linear growth in children below 3 years of age (Measured 50 months after randomization (endline survey 2019))
D: Food security as measured by the value of food consumption through a household questionnaire (6 months); Dietary diversity as measured by dietary diversity index and food consumption score through a household questionnaire (6 months)

Answer: D