TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Multi-faceted Intervention to Improve Supportive Care for Family Caregivers of Patients With Lung Cancer
Brief Summary: Family caregivers play a crucial role in cancer patients care, as they are their principal source of support. It is well recommended to provide them with the resources, information and support needed to maintain a good health, and to sustain their caregiving role. Recently, oncology centres have implemented systematic distress screening programs, but the focus has been limited to cancer patients, with little intervention on family caregivers. This study aims to address this gap. It will implement and test the effectiveness of a simple intervention integrating primary care and oncology care that transfers into practice the main recommendations of governmental authorities and experts to globally improve supportive care. The intervention includes systematic distress screening and problems assessment of family caregivers at diagnosis, and every two months, privileged contact with a nurse away from the patient to address caregivers distress and identified problems, and for caregivers experiencing high level of distress, liaison by the study nurse with their family physician to transfer information on their identified problems and level of distress and to facilitate shared follow-up. This intervention has been pilot-tested with family caregivers, health care providers and decision makers involved in lung cancer care, as well as with community-based family physicians, to ensure its feasibility and acceptability. This study findings may clearly improve patient and caregiver experience of cancer care, and reduce the burden of disease.


Options:
A: 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)
B: Change in the mean score of distress (Hospital Anxiety Depression Scale) (Baseline, after 3, 6 and 9 months); Change in the mean score of distress (Psychological distress scale used in the Quebec Health Survey) (Baseline, after, 3, 6 and 9 months)
C: 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)
D: PROMIS Physical Functioning (6 months); PROMIS Satisfaction With Social Roles (6 months); PROMIS Anxiety (6 months); PROMIS Depression (6 months); PROMIS Fatigue (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychological Treatments for Youth With Severe Irritability
Brief Summary: Background:

When children have severe irritability and temper outbursts, they can be so cranky or angry that it leads to problems at home, in school, and with friends. This is called Disruptive Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed specifically for children with this problem. Researchers think two forms of therapy, Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help children with DMDD.

Objective:

To test two whether IBT and CBT can decrease severe irritability in children and youth.

Eligibility:

Children 8-17 years old with DMDD. Their symptoms must have started before age 10.

Design:

Participants will be screened with a review of their symptoms. Parents and participants will answer questions.

Participants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT.

Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions.

Participants will talk about what makes them irritable and how it affects them. They may be put in situations that might make them annoyed or irritable.

Participants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews.

Participants will do practice activities at home.

Participants doing IBT will have up to 14 sessions over 10 weeks.

Participants will view 15 faces, one at a time, on a computer. They will choose if the face looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will complete some sessions at the NIH and some at home.

Participants and parents answer questions about their progress.

...


Options:
A: Child Behaviour Check List (CBCL) (12 months)
B: Objective 1: clinical manifestations (lifetime of protocol); Objective 2: behavioral, neuropsychological, neurophysiological, and neuroanatomical correlates (lifetime of protocol); Objective 3: genetic and familial correlates (lifetime of protocol)
C: Clinical Global Impression--Improvement score (Every two weeks); Affective Reactivity Index (ARI) (Every two weeks)
D: Change from baseline level of problem behavior at 4, 8, 12 and 16 weeks (0, 4, 8, 12, 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Endoscopic Application of a Hemostatic Powder TC-325 Versus Standard Treatment in the Control of Acute Upper Gastrointestinal Bleeding From Nonvariceal Causes; A Non-inferiority Randomized Trial
Brief Summary: Acute upper gastrointestinal bleeding is a common medical emergency. Bleeding peptic ulcers and other non-variceal causes constitute to about 95% of all cases of bleeding. Endoscopic treatment stops active bleeding, reduces rate of further bleeding and leads to improved patients outcomes. Endoscopic treatment can be technically demanding especially with lesions in difficult anatomic positions and to endoscopists with less experience. TC-325 is a propriety mineral blend hemostatic powder used to compress external civilian and military traumatic injuries. Investigators reported the first endoscopic application of TC-325 in 20 patients with actively bleeding gastro-duodenal ulcers. Investigators were able to stop bleeding in 19 of them. Subsequent case series from others reported a similar rate in the acute control of bleeding. To further define the role of TC-325 as a mono-therapy, a comparison to the current standard in endoscopic treatment is required. A non-inferiority randomized trial is being proposed to compare endoscopic use of TC-325 as a mono-therapy to current standards (i.e. hemoclips or thermo-coagulation with or without pre-injection with diluted epinephrine) in hemostatic treatment in patients with acute upper gastrointestinal bleeding from non-variceal causes. The non-inferiority primary endpoint is control of bleeding over 30 days from randomization. Other outcome endpoints include further endoscopic, angiographic or surgical treatments, hospitalization, blood transfusion and mortality. Investigators also compare ease of therapy measured by procedure time and a 10 cm visual analogue scale rated by endoscopists. Endoscopic application of TC-325 is a simple and less skill dependent technique. It may prove useful in bleeding from anatomically challenging sites of the gastro-duodenal tract.


Options:
A: The primary end point was to determine the effect of erythromycin on gastric cleansing and thereby quality of endoscopic visualization, reflecting the ease with which the procedure was performed in a clear stomach. (For upto 45 minutes from start to end of endoscopy)
B: Mortality (30 days)
C: Bleeding free probability in 30 days after randomization (30 days)
D: number of participants who presents and confirmed endoscopically as recurrent upper gastro-intestinal bleeding (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty?
Brief Summary: Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in total knee arthroplasty (TKA).


Options:
A: Morphine consumption the first 24 hours postoperatively (0-24 hours postoperatively); Serious adverse events (0-90 days postoperatively)
B: Total morphine consumption (At 48 hour postoperative)
C: Postoperative pain measurement employing a previous validated visual analogue scale of pain (VAS). (72 hours)
D: Cumulative use of morphine as assessed within first 48 hours after surgery (first 48 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Clinical Prediction Rules: Bringing Evidence to Diverse Primary Care Settings
Brief Summary: The study is a randomized controlled trial, with an Intervention Group and a Control Group at the University of Utah (U of U) and University of Wisconsin (UW). BU serves as the primary award and coordinating institution. The unit of randomization will be at the clinic level at each institution. UW will recruit all General Internal Medicine (GIM) Clinics and Department of Family Medicine (DFM) Clinics in Dane County as well as their East and West Urgent Care Clinics. U of U will recruit all affiliated primary care practices. The unit of randomization will be the clinic.

The study biostatistician will receive a list of clinic sites that have agreed to participate in the study from the site PIs. Clinics will be randomized to either Intervention group or to a Control group stratified by clinic size. Both groups will receive a single 45 minute academic detailing session describing evidenced-based diagnosis and treatment for strep throat and pneumonia. The Intervention Group will also receive a demonstration of the iCPR tool during their academic detailing session. Providers and clinic staff will be invited to the academic detailing session. Any provider or staff that is unable to attend the session will receive written and electronic copies of the material. Individual providers will not be specifically recruited for participation and they will participate or not based on personal preferences as they would for any clinic quality improvement project. The iCPR tool will be "turned on" for providers in the Intervention group. This means that the best practice alerts will trigger for appropriate patients with suspected strep throat or pneumonia.

We will collect and analyze data about the use of each element of the iCPR tool during patient visits, including which elements of the tool were used and how often. We will also collect data from the site EHRs about antibiotic and diagnostic test orders for strep throat and pneumonia from all clinics participating in the trial, both Intervention and Control groups.

After one year of study implementation, we will run an Interim Primary Outcome Report comparing the antibiotic and diagnostic test orders between the Intervention and Control group clinics. This report will be in the aggregate and will not contain any personally-identifiable information. If there is a significant difference between the groups that meets our predetermined stopping end points, we will stop the randomized controlled trial.


Options:
A: overall rate of antibiotic prescribing (2 years)
B: Antibiotic prescription rate (24 hours)
C: Proportion of patients receiving any antibiotic (2 weeks)
D: The proportion of recruited patients prescribed an antibiotic (6 Days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Randomized Control Trial of Arginine Therapy for Pediatric Sickle Cell Disease Pain
Brief Summary: The aim of this study is to determine whether giving extra arginine, a simple amino acid, to patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful events (VOE) will decrease pain scores, decrease the need for pain medications or decrease length of hospital stay or emergency department visit. Funding Source - FDA OOPD.


Options:
A: Gardos Channel Activity (12 weeks after randomization); Nitric Oxide (12 weeks after randomization); Mean Corpuscular Hemoglobin Concentration (12 weeks after randomization)
B: Total Parenteral Opioid Use in IV Morphine Equivalents (Post study drug delivery to discharge from the hospital (Up to 8 days))
C: To determine whether supplementation with LOVAZA will exert an anti-inflammatory effect by decreasing levels of the inflammatory biomarker high sensitivity C Reactive Protein (hsCRP) in children and adolescents with Sickle Cell Disease (SCD). (6 months)
D: The Number of Occurrences of Sickle Cell Crises (48 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE. The ROADSTER 2 Study.
Brief Summary: The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique.


Options:
A: Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days. (0 to 365 days)
B: composite of major adverse clinical events including death, any stroke, and/or myocardial infarction at 30-days post-procedure (30-days post-procedure); The same 30-day composite of major adverse clinical events plus death and/or ipsilateral stroke between 31-days and 12-months post-procedure. (Between day 31 and 12-months post-procedure.)
C: Number of Participants With Procedural Success (30 Days)
D: Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years. (30 days and 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tolerability to a New Free Amino Acid-based Formula in Children With Cow's Milk Protein Allergy
Brief Summary: It is a study to assess the tolerance to a new commercially available infant formula in children affected by Cow's Milk Allergy.


Options:
A: Study to assess the allergic symptoms, using a questionnaire. (5 months)
B: The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. (4 months)
C: Growth (5 years)
D: Weight (Study Day (SD) 1, 28 and 84)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Cross-over, PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter as an add-on Therapy, Coupled With Oral Vitamin D Supplementation vs. Placebo in a Randomised, Parallel-group Trial
Brief Summary: Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D supplementation or not, could be beneficial to improve disease LTC in AD patients


Options:
A: Proportion of eligible families screened who are willing and able to be randomised. (Before birth)
B: Hierarchical criterion based on repeated measures of PO-SCORAD severity score (2 years); Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter (2 years)
C: The incidence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of atopic dermatitis (Measure will be reported annually by year from 2008-2018); The prevalence of diagnosed co-morbidities in people with and without atopic dermatitis (Prevelence reported annually by year from 2008-2018); Annual rates of service utilisation (number of primary and secondary care visits) in people with atopic dermatitis (Measures will be reported annually by year from 2008-2018); Annual prescription rates for atopic dermatitis related treatments (Measures will be reported annually by year from 2008-2018)
D: Clinical improvement during UVA1/NB-UVB phototherapy using a validated; SCORAD index

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Dual Task Training on Motor and Non-Motor Function in Individuals With Parkinson's Disease
Brief Summary: The primary aim of the proposed project is to characterize dual tasking (DT) deficits to improve motor, cognitive, and quality of life outcomes in individuals with Parkinson's disease (PD). Phase 1 of the intervention will involve an in-depth gait analysis on 15 individuals with PD. This gait analysis will utilize the Computer Assisted Rehabilitation Environment (CAREN) system, a virtual reality system with a fully integrated 3-D motion capture system. The purpose of Phase 1 is to generalize characteristics of gait and postural control during specific DT conditions. Phase 2 (N=20) involves the clinical translation of these findings. This phase will involve creating a clinical intervention based on the objective information gathered the CAREN system. The intervention will take place 3x/week for a total of 8 weeks. Interventional groups will include: 1) DT clinical group (N=10) and 2) Single task group (N=10). Outcome measures will be used at the beginning and end of the intervention to assess the feasibility and efficacy of the intervention.


Options:
A: Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary (Baseline and Weeks 4, 8, 12, and 16)
B: Step Length During Gait (Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks); Walking Speed During Gait (Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks)
C: Percentage of "Off" Time During Waking Hours at End of Study (22 weeks)
D: Falls rate (6 months post intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor
Brief Summary: Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it was withdrawn from the US market more than 10 years ago. As already known well, ritodrine has many side effects such as tachycardia, hyperglycemia, pulmonary edema and so on. When such complications of ritodrine appears, clinicians consider of using MgSO4 as substitute, but its use is off-the-label yet in Korea. Facing this discrepancy, the investigators want to compare the efficacy and safety of MgSO4 with ritodrine and prove that MgSO4 is not inferior to ritodrine as tocolytics. For the singleton and twin pregnancies between 24+0weeks and 34 completed weeks whose uterine contraction is more than 4 during 20 minutes period with their cervical ripening is more than 25%, the investigators randomise them in Ritodrine group or MgSO4 group. Then, the investigators will check the change of their interval of uterine contraction, degree of pain and the appearance of any side effects or treatment failure sign.


Options:
A: Efficacy of MgSO4 as tocolytics : increased interval of uterine contraction, decreased maternal painful sensation, stopping the cervical change (48 hours later)
B: In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures (At delivery)
C: hours of latency to delivery (0 hours to > 168 hours)
D: gestational age at delivery (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Low InTensity Exercise Intervention in PAD
Brief Summary: This proposed study will determine whether a home-based exercise intervention that avoids continuous supervision and exercise-related ischemic pain improves walking performance at 52-week follow-up in people with PAD, compared to an attention control group and compared to a high intensity exercise intervention. In our secondary aims, we will determine whether high intensity exercise improves six-minute walk distance as compared to the attention control group. In secondary aims, we will also determine whether low intensity exercise and high intensity home-based exercise, respectively, improve patient reported outcomes, physical activity, and treadmill walking performance compared to attention control. Our intervention directly addresses two aspects of current practice guidelines that are major barriers to exercise for patients with PAD: 1) the recommendation for supervised exercise and 2) the recommendation for high intensity ischemic-pain inducing walking exercise.


Options:
A: Depression, as assessed the Patient Health Questionnaire-9 (Baseline, Weeks 2-6)
B: Six-minute Walk Distance (change from baseline to week 52)
C: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (3 months)
D: Maximum Walking Distance (MWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)); Pain-free Walking Distance (PFWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)); Functional Walking Distance (FWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months))

Answer: B