TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Brief Summary: Caring for people with dementia (PwD) at home requires an enormous amount of time, organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD often feel a high burden. Even though support groups on-site have shown positive effects on the subjective well-being and on the perceived social support of ICs, relatives either have no time or opportunity to leave the PwD alone or there are no support groups in the vicinity. The Talking Time project therefore aims to close this supply gap by providing structured telephone-based support groups in Germany for the first time. International studies have shown resulting benefits for ICs.

Methods/Design: The project will be evaluated in a cluster adjusted randomized controlled trial. The effects of the 3-months Talking Time intervention will be compared to a normal care group. Outcomes will be measured at two different times (baseline = T0, after 3 months =T1). The control group will receive the Talking Time intervention after T1.

ICs are eligible if they are 18 or older, have cared for the PwD for at least four hours on four days per week in the last six months. Exclusion criteria are psychiatric disorders of the IC.

Primary outcome of the effectiveness elevation is the subjective well-being of the relatives measured by the mental component of the SF-12. Secondary outcomes are the physical component summary of the SF-12, the Perceived Social Support Caregiver Scale, the Caregiver Reaction Scale and the Neuropsychiatric Inventory. For the process evaluation different quantitative and qualitative data sources will be collected addressing reach, fidelity, and dosage.


Options:
A: Change in Caregiver Burden From Baseline (baseline to end-of-treatment (6 months)); Change in Frequency of Patient Problematic Behavioral Patterns From Baseline (baseline to end of treatment (6 months)); Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline (baseline to end of treatment (6 months)); Change in Caregiver Depression From Baseline (baseline to end-of-treatment (6 months))
B: Perceived stress (every 3 months (between 0 and 6 months))
C: Caregiver Burden Inventory (one year); Proportion of days spent at home by the AD patient in the past year (one year)
D: Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Brief Summary: Caring for people with dementia (PwD) at home requires an enormous amount of time, organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD often feel a high burden. Even though support groups on-site have shown positive effects on the subjective well-being and on the perceived social support of ICs, relatives either have no time or opportunity to leave the PwD alone or there are no support groups in the vicinity. The Talking Time project therefore aims to close this supply gap by providing structured telephone-based support groups in Germany for the first time. International studies have shown resulting benefits for ICs.

Methods/Design: The project will be evaluated in a cluster adjusted randomized controlled trial. The effects of the 3-months Talking Time intervention will be compared to a normal care group. Outcomes will be measured at two different times (baseline = T0, after 3 months =T1). The control group will receive the Talking Time intervention after T1.

ICs are eligible if they are 18 or older, have cared for the PwD for at least four hours on four days per week in the last six months. Exclusion criteria are psychiatric disorders of the IC.

Primary outcome of the effectiveness elevation is the subjective well-being of the relatives measured by the mental component of the SF-12. Secondary outcomes are the physical component summary of the SF-12, the Perceived Social Support Caregiver Scale, the Caregiver Reaction Scale and the Neuropsychiatric Inventory. For the process evaluation different quantitative and qualitative data sources will be collected addressing reach, fidelity, and dosage.


Options:
A: Perceived stress (every 3 months (between 0 and 6 months))
B: Change from baseline in subjective burden using the Zarit Burden Interview (ZBI) (Baseline, Month 3, Month 6)
C: Effects of the WeCareAdvisor Tool on Caregiver Upset (4 weeks); Effect of the WeCareAdvisor Tool on Caregiver Confidence (4 weeks)
D: Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nursing Home Care Educational Intervention for Family Caregivers of Older Adults Post Stroke
Brief Summary: Associated with the worsening of functional capacity of older adult and the lack of guidance on how to care of them after stroke, the family caregiver starts to fell burden related to the care, and the quality of life was affected by that burden. Besides that, the older adult began to use more frequently health services and had more hospitalizations by preventable conditionals with adequate care.

The aim of this study is to evaluate the effectiveness of educational interventions of care at home provide by nurses to family caregivers of older adult with stroke after hospital discharge, compared with usual care guidelines or no guidance, in one month follow up. The family caregivers of older adults post stroke with the first functional sequel from the Clinical Hospital of Porto Alegre (HCPA) will participate in the study.

The intervention will involve the systematic monitoring of nurses through home visits (HVs) during one month. Thus, will instrumentalize the family caregiver to care of older adult with stoke according the protocol developed in a research group and the needs of care of them. The control group won't receive the home visits and could have or not the usual care guidelines provide by health services that have access.


Options:
A: The family caregiver's burden of care analyzed by Caregiver Burden Scale (2 months)
B: Stroke Specific Health Related Quality of Life (6 months for (SSQoL) and 3 months for Perceived Energy Subdomain); Self-Efficacy to Manage Stroke Symptoms (6 months)
C: Change in Systolic Blood Pressure (baseline and 6 months); Change in HDL Level (baseline and 6 months); Change in LDL Level (baseline and 6 months); Change in Triglyceride Level (baseline and 6 months); Change in HbA1c Level (baseline and 6 months); Change in Glycaemia Level (baseline and 6 months); Change in BMI Value (baseline and 6 months)
D: Wolf Motor Function Test (WMFT) (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)); Motor Activity Log (MAL) Score (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)); Family Caregiver Conflict Scale (FCCS) Score (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)); Center for Epidemiologic Studies Depression Scale (CES-D) Score (Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Propofol and Dexmedetomidine to Treat Hyperactive and Mixed ICU Delirium - the Basel ProDex Randomized Trial
Brief Summary: In this randomized study, the investigators aim to test the hypothesis that the reinstitution of a normal circadian rhythm by continuous infusions of dexmedetomidine compared to propofol between 8pm and 6am after diagnosis of hyperactive or mixed delirium, decreases the duration of delirium. The infusions might have to be repeated several times to achieve resolution of delirium.


Options:
A: Reduction of ICU delirium duration assessed by ICDSC checklist (during stay at ICU, an average of 3 days; Delirium duration assessed every 8 hours starting with patient's ICU admission until delirium has subsided)
B: Ventilator-free hours (7 days following randomisation)
C: delirium- and coma-free days (within the first 14 days after randomisation)
D: Time from the commencement of treatment to extubation (days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Meeting the Needs of Pregnant Women With PTSD in Prenatal Care
Brief Summary: The objectives of this research study are to screen 750 pregnant women at risk of trauma-related stress symptoms, and adapt and test an evidence-based intervention for pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer community health centers.


Options:
A: Depressive symptoms, social functioning, and health (Measured at Months 3, 6, and 12 postpartum); Preferences for depression treatment (Measured at baseline and Month 12)
B: Change in posttraumatic stress disorder symptoms (The primary endpoint is one month postpartum); Preterm labor (the primary endpoint is one month postpartum); Birthweight (the primary endpoint is one month postpartum)
C: mother and father resolving of conflict (pre-intervention, post-intervention (up to 9 months after pre-intervention), up to 18 months after pre-intervention, up to 27 months after pre-intervention)
D: Psychopathology (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing a Brief Early Cognitive Intervention for PTSD and Alcohol Misuse
Brief Summary: The broad aim of this study is to develop and test a brief intervention that can be implemented in the immediate weeks following sexual assault to decrease likelihood of developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the study will enroll 6 women to complete a brief, cognitive therapy protocol and provide feedback on the intervention (open trial). The second phase of the study will recruit 76 women to complete either the intervention (38 women) or assessment only (38 women) to test the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to natural recovery following assault.


Options:
A: PTSD (Before session, middle, end, one year follow-up, 18 month follow-up)
B: Change in Pittsburgh Sleep Quality Index total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU); Change in Modified PTSD Symptom Scale - Self Report total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU)
C: Change in Percent Drinking Days on The Time Line Follow-Back (Participants will report on drinking during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.); Change in number of standard drinks per drinking day on The Time Line Follow-Back (Participants will report on drinking during the 30 days prior to initiation of the study, and ever day until completion of study visits, approximately six weeks.); Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) (Baseline and after completion of study visits, approximately six weeks.); Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders (Baseline and after completion of study visits, approximately six weeks.)
D: Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) (12 weeks); Timeline Followback Heavy Episodic Drinking Episodes (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing a Brief Early Cognitive Intervention for PTSD and Alcohol Misuse
Brief Summary: The broad aim of this study is to develop and test a brief intervention that can be implemented in the immediate weeks following sexual assault to decrease likelihood of developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the study will enroll 6 women to complete a brief, cognitive therapy protocol and provide feedback on the intervention (open trial). The second phase of the study will recruit 76 women to complete either the intervention (38 women) or assessment only (38 women) to test the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to natural recovery following assault.


Options:
A: Drug Abuse Screening Test (DAST-10) (6 months); Alcohol Use Disorders Identification Test (AUDIT) (6 months); Cigarettes (Estimated Number) (14 days preceding 6 week, 3 month and 6 month follow-up); Amount of Alcohol Use (14 days prior to 6 week, 3 month, 6 month follow-up); Marijuana Use Frequency (14 days prior to 6 week, 3 month, 6 month follow-up)
B: Impact of Events Scale-Revised 'IESR' (Change from Baseline PTSD symptomology at up to 5 months); The Psychology Experiment Building Language 'PEBL' Test (Change from Baseline neuropsychological functioning at up to 5 months); Generalized Anxiety Disorder 7 (GAD-7) Scale (Change from Baseline anxiety levels at up to 5 months); Patient Health Questionnaire 9 (PHQ-9) Scale (Change from Baseline depression levels at up to 5 months); Weekly Problems Rating Scale (Change from Baseline emotional and behavioural functioning at up to 5 months); Rosenberg Self-Esteem Scale 'RSES' (Change from Baseline levels of self-worth at up to 5 months); The Valued Living Questionnaire 'VLQ' (Change from Baseline quality of life issues at up to 5 months)
C: Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) (12 weeks); Timeline Followback Heavy Episodic Drinking Episodes (12 weeks)
D: Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) (Baseline, changes from baseline at 1 week post-treatment, 3 months post-treatment, and 6 months post-treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
Brief Summary: The purpose of this study is to compare three strategies for finding TB cases in a rural Sub-Saharan African setting: 1) Screening all attendees of primary care clinics for TB; 2) Conducting household contact investigations of newly diagnosed TB cases; 3) Providing incentives to newly diagnosed TB cases and their contacts to promote contact screening for TB. For each intervention, investigators will measure comparative effectiveness in terms of cases identified as well as the cost-effectiveness and feasibility of implementation.


Options:
A: Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics (18 months); Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms (36 months)
B: To evaluate the diagnostic performance of C-Tb in relation to age, HIV and CD4 counts (Onset between the injections and 28 days after the injections); To evaluate the clinical safety of C-Tb, with emphasis on children and HIV positive participants (Onset between the injections and 28 days after the injections)
C: Tuberculosis diagnostic algorithm (3 years)
D: To demonstrate an increasing trend in C-Tb test positivity across the four study groups, with 'positivity' defined as an induration ≥ 5 mm (Onset between the injections and 28 days after the injections)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SYNchronizing Exercises, Remedies in GaIt and Cognition (SYNERGIC): A Randomized Controlled Double Blind Trial
Brief Summary: The proposed SYNERGIC trial is uniquely designed to evaluate the effect of aerobic and progressive resistance training exercises, combined with cognitive training and Vitamin D3 supplementation, in cognition and mobility in older adults with Mild Cognitive Impairment (MCI).


Options:
A: Working Memory function. (Changes from baseline (3, 6 and 12 months after intervention).)
B: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
C: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
D: overall cognition (2 Monhths)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SYNchronizing Exercises, Remedies in GaIt and Cognition (SYNERGIC): A Randomized Controlled Double Blind Trial
Brief Summary: The proposed SYNERGIC trial is uniquely designed to evaluate the effect of aerobic and progressive resistance training exercises, combined with cognitive training and Vitamin D3 supplementation, in cognition and mobility in older adults with Mild Cognitive Impairment (MCI).


Options:
A: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
B: Aggregate Cognitive Performance (Baseline to 10 weeks)
C: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
D: Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. (Changes from baseline at 4 months in z-scores.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SYNchronizing Exercises, Remedies in GaIt and Cognition (SYNERGIC): A Randomized Controlled Double Blind Trial
Brief Summary: The proposed SYNERGIC trial is uniquely designed to evaluate the effect of aerobic and progressive resistance training exercises, combined with cognitive training and Vitamin D3 supplementation, in cognition and mobility in older adults with Mild Cognitive Impairment (MCI).


Options:
A: sleep measures (3-6 months)
B: Working Memory function. (Changes from baseline (3, 6 and 12 months after intervention).)
C: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
D: Aggregate Cognitive Performance (Baseline to 10 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SYNchronizing Exercises, Remedies in GaIt and Cognition (SYNERGIC): A Randomized Controlled Double Blind Trial
Brief Summary: The proposed SYNERGIC trial is uniquely designed to evaluate the effect of aerobic and progressive resistance training exercises, combined with cognitive training and Vitamin D3 supplementation, in cognition and mobility in older adults with Mild Cognitive Impairment (MCI).


Options:
A: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
B: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group)
C: Neuropsychological testing (Baseline, 12 weeks, and 24 weeks); Oddball task (Baseline, 12 weeks, and 24 weeks); Wisconsin task (Baseline, 12 weeks, and 24 weeks); Speed of processing task (Baseline, 12 weeks, and 24 weeks); Spatial working memory (WM) (Baseline, 12 weeks, and 24 weeks)
D: Useful Field of View Test (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacological Treatment of Narcotic Neonatal Withdrawal
Brief Summary: Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.


Options:
A: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
B: Cumulative dose of morphine required to treat NAS. (14 days of age); Highest dose of morphine required to treat NAS. (14 days of age)
C: Duration of treatment (0 to 42 days)
D: Length of Hospitalization (Up to 4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacological Treatment of Narcotic Neonatal Withdrawal
Brief Summary: Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.


Options:
A: Heart Rate (up to 2 weeks); Respiratory Rate (up to 2 weeks); O2 sats (up to 2 weeks); Activity level (up to 2 weeks); Sleep category (up to 2 weeks); Feeding (sucking and absorption) category (up to 2 weeks); Neonatal Abstinence Scoring (NAS) (up to 2 weeks)
B: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
C: Length of Hospitalization (Up to 4 months)
D: Duration of treatment (0 to 42 days)

Answer: D