TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: High-dose Mass Practice Intervention to Reduce ADL Disability in Dementia
Brief Summary: People with Alzheimer's disease and related dementias present with changes in how they think, move and emotionally respond to daily life situations. While type of dementia will dictate how severe certain symptoms are, all people with dementia will report a gradual change in how they function in daily life skills. Losing the ability to do daily life tasks, such as using a cell phone, balance a checkbook or get dressed in the morning signifies loss for both the person with dementia and their caregiver. Caregivers that assist with daily life tasks report more depression and anxiety, as well as a higher burden of care. People with dementia that lose the ability to perform daily tasks report more depression and decreased satisfaction with life. Despite gains in research, researchers are still missing important pieces that will improve rehabilitation interventions for improving daily life skills.

In order to address the needs of people with dementia, an intervention called Skill-building through Task-Oriented Motor Practice (STOMP) was developed by an occupational therapist. Our team proposes that improvement in daily life skills is possible under certain circumstances. First, the daily life task a person is addressing in rehabilitation should be personally-meaningful and should also be the task practiced in therapy which is called "task-oriented training". For example, a person that is having trouble making a sandwich should practice making a sandwich. Second, the investigators propose that people with dementia need a lot of "correct practice" so that the brain has time to "rewire" how to do the task correctly. Therefore, when patients practice tasks using STOMP, investigators do not allow our participants to make errors and patients practice for long periods of time. Investigators also incorporate and provide new technology into training such as medication reminder alarms and photo phones which allow you to dial a number by choosing a loved one's picture.

In this pilot study, the investigators want to look more closely at the how the amount of time you practice influences study outcomes. The investigators believe that the findings from this study will support our belief that more time in therapy is needed to enhance how someone with dementia learns.


Options:
A: 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);; 2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);; 3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
B: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (24 months)
C: ADL/IADL (Baseline, t2, t3); Caregiver upset (Baseline, t2, t3); Caregiver confidence (when needed); Behaviors (Baseline, t2, t3)
D: 5 point Observation of Activities of Daily Living (Baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dagbøger Til Kritisk Syge Patienter Skrevet af pårørende: Betydning for Patient og pårørende Samt Effekt i Forhold Til Udvikling af Symptomer på Posttraumatisk Stress
Brief Summary: This study will investigate the effect of diaries written by relatives for critically ill patients on the risk of posttraumatic stress symptoms.

Utilizing a randomized controlled design pairs of one patient and one relative will be assigned to either diary intervention or standard care. The effect of the diary will be evaluated using a questionnaire 3 months post charge.

The results of this study will add to the body of knowledge on how diaries may help critical care survivors and their relatives to proceed with their lives.


Options:
A: PTSD ratings (Measured at Year 1); Substance use (Measured at Year 1); General functioning reports (Measured at Year 1)
B: Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. (Change from baseline at weeks 2, 6 and 12)
C: Quality of Life (12 months)
D: PTSS-14 (Post Traumatic Stress Symptoms) (3 months post discharge from ICU)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess the Efficacy, Safety, and Tolerability of Multiple Subcutaneous Injections of Depot Buprenorphine (RBP-6000 [100 mg and 300 mg]) Over 24 Weeks in Treatment-Seeking Subjects With Opioid Use Disorder
Brief Summary: This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.


Options:
A: Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 (Weekly from Weeks 5-24)
B: percentage of subjects abstinent from all opioids through the final day of detoxification (up to 12-week trial)
C: Opiate abstinence
D: Analgesia (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative Connected Health (CCH): A Pragmatic Trial Evaluating Effectiveness of CCH in Psoriasis Management Compared to In-person Visits.
Brief Summary: The investigators propose to evaluate whether an innovative collaborative connected health (CCH) model increases access to specialists and improves patient outcomes. CCH offers multiple modalities for patients and primary care providers (PCPs) to access dermatologists online directly and asynchronously to maximize effectiveness in a real-world setting. CCH also fosters team care and patient engagement through active sharing of management plans and multidirectional, informed communication among patients, PCPs, and dermatologists. The specific aims of the proposal are to (1) determine whether the CCH model results in equivalent improvements in psoriasis disease severity compared to in-person care, (2) determine whether the CCH model results in equivalent improvements in quality of life and mental health compared to in-person care, and (3) assess whether the CCH model provides better access to care than in-person care.


Options:
A: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)
B: Changes in mean SBP (From baseline (T1) to 12 months (T3))
C: Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI) (12 months)
D: Specialist referral rate per 100 patients seen (to medical specialties available through eConsult) (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative Connected Health (CCH): A Pragmatic Trial Evaluating Effectiveness of CCH in Psoriasis Management Compared to In-person Visits.
Brief Summary: The investigators propose to evaluate whether an innovative collaborative connected health (CCH) model increases access to specialists and improves patient outcomes. CCH offers multiple modalities for patients and primary care providers (PCPs) to access dermatologists online directly and asynchronously to maximize effectiveness in a real-world setting. CCH also fosters team care and patient engagement through active sharing of management plans and multidirectional, informed communication among patients, PCPs, and dermatologists. The specific aims of the proposal are to (1) determine whether the CCH model results in equivalent improvements in psoriasis disease severity compared to in-person care, (2) determine whether the CCH model results in equivalent improvements in quality of life and mental health compared to in-person care, and (3) assess whether the CCH model provides better access to care than in-person care.


Options:
A: 1. ADEs; 2. duration of ameliorable medication side effects; 3. health goal adherence rates; 4. diabetes outcomes; 5. familial risk factor documentation rates; 6. user satisfaction surveys; 7. user metrics
B: Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI) (12 months)
C: Severity and duration of symptom distress (At baseline and at 2, 4, 6, 8 and 12 months); Anxiety and depression (At baseline an at 2, 4, 6, 8 and 12 months)
D: Body weight change (baseline and after 4weeks of lifestyle intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HIV & Drug Abuse Prevention for South African Men
Brief Summary: The purpose of this study is to test the efficacy of randomizing all young men in a neighborhood to receive: 1) soccer training; 2) soccer and vocational training; or 3) a control condition, as a means to engage young men in HIV prevention. The investigators hypothesize that the intervention will reduce young men's substance use and increase HIV testing.


Options:
A: Parenting practices (One month and six months post-intervention)
B: CD4 count (6-monthly); RNA viral load (6-monthly); Haemoglobin (6-monthly); self-reported adherence (CASE index) (6-monthly); health-related quality of life (EQ-5D/EQ-VAS) (6-monthly); anthropometrics (monthly to 6-monthly); food security (USDA scales) (6-monthly); time allocation/physical activity levels (6-monthly); household welfare (6-monthly)
C: Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS) (Change in DD-CDAS score at 6 months post-intervention)
D: The primary outcome is the number of outcomes out of 15 outcomes significantly favoring the intervention over the control (Harwood, Weiss & Comulada, 2017) (Baseline to 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ASCEND: A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression
Brief Summary: Patients whose kidneys fail generally require dialysis treatments to sustain life. The ability of patients to make major adjustments in their lives for dialysis is hampered by depression that affects almost one-quarter of such individuals. There are no studies that have adequately tested whether treatment of depression is effective in dialysis patients and if there is any difference between the response to the two most commonly available forms of treatment, psychotherapy and anti-depressant drug therapy.

To fill this important gap in the investigators knowledge, the investigators propose to undertake (1) a randomized controlled clinical trial of 200 patients to test whether an engagement interview will result in a higher proportion of dialysis patients accepting treatment for depression; and (2) a randomized controlled clinical trial of 120 patients to determine whether there is any difference in the likelihood of improvement of depressive symptoms with psychotherapy or drug therapy among dialysis patients with depression. Patients in these studies will be enrolled from among individuals receiving care in 50 dialysis facilities in three metropolitan areas - Seattle, Dallas, and Albuquerque. The research proposal has been developed with the support of patients, caregivers, and stakeholders to ensure that the findings from the study are relevant to them and can be readily implemented in day-to-day clinical practice. Hence, the engagement interview and psychotherapy will be delivered in a dialysis facility to ease the burden on patients, and the dose of the study drug will be changed in partnership with the study participants. In addition to depressive symptoms, the effect of treatment on other meaningful outcomes such as fatigue and sleep will be determined.

The two forms of treatment for depression being tested in this clinical trial are very different from each other and patients differ with regards to the treatment option preferable and/or available to them. Successful completion of the clinical trial will provide patients, caregivers, and other stakeholders with the information that they would need when faced with a diagnosis of depression in patients undergoing hemodialysis. This will allow patients to select evidence-based treatments to improve outcomes that are relevant to them.


Options:
A: Insomnia Severity Index (ISI) Short-term (Week 7); Insomnia Severity Index (ISI) Long-term (Week 25)
B: Number of Participants Who Initiated Depression Treatment (within four weeks of engagement interview or control visit); QIDS-C Score (Week 12 of treatment)
C: State-Trait Anxiety Inventory (Baseline, 8 weeks, 26 weeks)
D: Change in Body Heat Storage (Changes from baseline at 7 months); Change in Insulin Resistance (Changes from baseline at 7 months); Change in Muscle Size (Changes from baseline at 7 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The "Peripheral Access Utilizing Sonographic Evaluation" Study
Brief Summary: The purpose of this study is to reduce, by using the ultrasound guided technique, the minor surgical procedures that might be required to deliver fluids into the blood of critically ill patients simply because the patients' veins cannot be located through the manual technique.


Options:
A: successful placement of a venous catheter on the first attempt (within the hour after insertion of peripheral venous catheter)
B: Reduction in number of minor surgical procedures that may be required to deliver fluids into the blood of critically ill patients by using the ultrasound guided technique (1 Day)
C: Reducing the use of CVC and PVC (through study completion, an average of 7 month)
D: Length of canalization (Four weeks); Number of punctures (Four weeks); Phlebitis (Four weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The "Peripheral Access Utilizing Sonographic Evaluation" Study
Brief Summary: The purpose of this study is to reduce, by using the ultrasound guided technique, the minor surgical procedures that might be required to deliver fluids into the blood of critically ill patients simply because the patients' veins cannot be located through the manual technique.


Options:
A: Reduction in number of minor surgical procedures that may be required to deliver fluids into the blood of critically ill patients by using the ultrasound guided technique (1 Day)
B: First pass success (1 day); Number of attempts (1 day); Overall success (1 day); Time to completion (1 day)
C: Number of Participants with Successful Securing of Peripheral Vein on First Attempt (60 minutes)
D: Reducing the use of CVC and PVC (through study completion, an average of 7 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases
Brief Summary: This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.


Options:
A: Progression-free-survival (6 months)
B: Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) (Baseline and 4 months from start of treatment)
C: Cognitive Decline (4 months)
D: Time to Neurocognitive Failure (From randomization to last follow-up. Maximum follow-up was 15.6 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
Brief Summary: This project is Project three of a four project Prevention Coaching Lab CREATE grant entitled "Transforming Prevention into Action" aimed at effectively engaging patients and their families to improve their health and medical care.

This project will test the feasibility and effectiveness of the prevention focused, internet mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans.


Options:
A: Systolic blood pressure (12-months)
B: Change in Glycosylated hemoglobin (HbA1c) (Baseline and 12 months)
C: Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device (Change from Baseline in objectively monitored physical activity at one year after randomization)
D: Medication Adherence (12 months after intervention); Mean Proportion of Days Covered Relative to Usual Care (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Adolescent Health Through Personalized Feedback
Brief Summary: The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e., "Check Yourself") to usual care. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services.


Options:
A: Number of Health risk behaviors (3 months); Number of risk behaviors counseled on during primary care appointment (1 day)
B: Average peak symptom burden in the intervention group versus the control group (Measured by comparing the average PRO-CTCAE scores from Day+7, Day+10, and Day+14 in the intervention compared to the control group)
C: Quality Of Life In Epilepsy (QOLIE)-31 global score (Month 18); Adverse Events Profiles (AEP) score (Month 18)
D: Adjuvant Endocrine Therapy (AET) Medication Adherence (Up to Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
Brief Summary: The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.


Options:
A: Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study (Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through follow-up period, up to 1 year after study entry)
B: Reduction of rhinovirus-induced common colds. (9 weeks)
C: Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Unsolicited Adverse Events (AEs) (During the 30-Day (Days 0-29) post-vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (From vaccination at Day 0, up to Day 30 post-vaccination); Titres of RSV-A Neutralizing Antibodies (At Day 0 pre-vaccination); Titres of RSV-A Neutralizing Antibodies (At Day 30 post-vaccination)
D: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke An Assessor-blind, Randomized, Non-inferiority Trial
Brief Summary: The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke.


Options:
A: Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy (from the Baseline Visit to the 30 Day Follow Up Visit)
B: Change from baseline in mobility at 2 and 4 months (before the intervention, month 2 and month 4); Change from baseline in Balance at 2 and 4 months (before the intervention, month 2 and month 4)
C: Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient) (7 days and 90 days post discharge); Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient) (7 days and 90 days post discharge); Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver) (7 days and 90 days post discharge)
D: Hamilton Rating Scale for Depression (HRSD) (1 year post-treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Advancing Tobacco Use Treatment for African American Smokers
Brief Summary: The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
C: Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26 (Change from Baseline to Week 26)
D: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: A