TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Supporting Elderly People With Cognitive Impairment During and After Hospital Stays- Intersectoral Care Management [Verbundprojekt Intersec-CM - sektorenübergreifendes Care Management Zur Unterstützung Kognitiv beeinträchtigter Menschen während Und Nach Einem Krankenhausaufenthalt]
Brief Summary: Sectorisation of the German health care system causes inefficient treatment, especially in elderly with cognitive impairments. At time of transition from hospitals into primary care it lacks, among others, coordination of post-operative care or timely communication between healthcare providers. This results in deterioration of disease and comorbidities, higher rates of re-admission and institutionalizations. Models of collaborative care have shown their efficacy in primary care. Main goal is to test the effectiveness of Dementia Care Management (DCM) for people with cognitive impairment to improve treatment and care across the in-hospital and primary care sector.

The study design is a complex, longitudinal, multisite randomized controlled trial. It was designed to treat a hospital-based epidemiological cohort of people above the age of 70 with an adaption of DCM, a treatment proven to be effective in primary care, to the discharge setting. As part of this, specifically trained study staff will develop, implement and monitor a treatment and care plan, based on comprehensive assessments during the hospital stay, recommendations at discharge and unmet needs at home. For the 3 months after discharge study staff will coordinate treatment and care in close cooperation with the discharging hospital, treating physician and other care providers.

Expected results from the study should facilitate the implementation of intersectoral care management systematically on a large scale. Thus, the benefits shown in the trial would be available to a larger population. Results will not be limited to PCI, but rather to any people transitioning between the in-hospital and the primary care sector. Thus, the benefits would be available to elderly people in general.


Options:
A: Instrumental and Physical Functionality (Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)); Re-Admission to Hospital (Assessed 3 months and 12 months after the time of hospital discharge (T1, T2).); Institutionalisation (Assessed 12 months after the time of hospital discharge (T2).)
B: Participant Reduced Symptom Burden (From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion))
C: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
D: postoperative delirium (2 MONTHS)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Feasibility Study of Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal
Brief Summary: This is a pilot feasibility study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate feasibility and acceptability of the intervention to determine procedures and content for a subsequent full trial using a cluster-randomized design of group problem management plus versus enhanced treatment as usual.


Options:
A: Parenting Behavior Assessment (adapted from multiple scales for this context) (1 month); Parenting Self-Efficacy and Beliefs Assessment (adapted from other scales for this context; includes unique items developed for this context) (1 month); Child Behavior Assessment (items adapted from the Strengths and Difficulties Questionnaire) (1 month); Parent-Child Interaction Observation (1 month); Child Cognitive / Pre-Academic Abilities and Emotional Well-being (1 month)
B: Change in levels of externalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, Externalizing Scale (Pre-Post (approximately 16 - 20 weeks after pre-assessment)); Change in Prevalence of Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD)) in children: The Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version; MINI-KID-P Clinician-rated (Pre-Post (approximately 16 - 20 weeks after pre-assessment))
C: Change from Baseline in Mental Health of Children and Caregivers (Administered to caregivers and school-aged children in each cohort three times: once within 15 days prior to the start of the intervention, once within 15 days of intervention completion, and again 4 months following intervention completion.)
D: Depression - Patient Health Questionnaire (1 week post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Feasibility Study of Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal
Brief Summary: This is a pilot feasibility study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate feasibility and acceptability of the intervention to determine procedures and content for a subsequent full trial using a cluster-randomized design of group problem management plus versus enhanced treatment as usual.


Options:
A: depression (pre, post and 6 months post treatment)
B: Change of depression symptom from baseline at 3 and 6 months (0-3-6 months); Change of anxiety symptom from baseline at 3 and 6 months (0-3-6 months); Change of chronic pain symptom from baseline at 3 and 6 months (0-3-6 months); Change of anger from baseline at 3 and 6 months (0-3-6 months); Change of PTSD symptom from baseline at 3 and 6 months (0-3-6 months)
C: Depression - Patient Health Questionnaire (1 week post-intervention)
D: Stunting (One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline); Cognitive function (End line (after one year); Amendment: BSID-III at year two (extension) endline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Feasibility Study of Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal
Brief Summary: This is a pilot feasibility study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate feasibility and acceptability of the intervention to determine procedures and content for a subsequent full trial using a cluster-randomized design of group problem management plus versus enhanced treatment as usual.


Options:
A: Primary Outcome Measure(s) evaluate the efficacy and cost-effectiveness of the intervention in reducing carer burden, improving behaviour problems in elderly persons with dementia and reducing the costs of illness. (by the end of the study)
B: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
C: Changes in HIV medication adherence throughout intervention phase (Assessed between baseline and the 4 month assessment); Depression scores as assessed by an independent (blind assessor) after intervention. (4 month assessment)
D: Depression - Patient Health Questionnaire (1 week post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of a Counseling Intervention on Post-cesarean Section Narcotic Use: a Randomized Controlled Trial
Brief Summary: This study is a randomized controlled trial to investigate the effect of a simple counseling intervention on post-operative narcotic requirements, with the hypothesis that women receiving this intervention will use fewer narcotics for pain management following cesarean section.


Options:
A: quantity of narcotics used in-hospital (4 days)
B: Number of Subjects Who Achieved 50% Sustained Pain Reduction (12 days)
C: pain, to be evaluated using a numerical rating score (NRS) on a 100mm scale (0= no pain whatsoever, 100 = unbearable pain). (4 weeks)
D: Lowest Pain Level Postoperative (24 hours postoperative); Average Pain Level Postoperative (24 hours postoperative); Worst Pain Level Postoperative (24 hours postoperative)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries
Brief Summary: This study will randomise people with clinically significant COPD (GOLD Grade B-D) to usual care or provision of a self-management action plan supported by monthly follow-up visits from a community health worker trained in the use of the action plan. The primary outcome will be health-status: a comparison of the change in St. George's Respiratory Questionnaire (SGRQ) between baseline and 12 months in the two groups. We will randomise 240 people from three low- and middle-income countries, namely Nepal, Peru and Uganda. We will also examine the feasibility of implementing our self-management action plan intervention at scale.


Options:
A: Change in SGRQ (12 months)
B: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)
C: Changes in rate of remission of depression (At 12 months of follow-up)
D: thoracoabdominal motion (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: High-Intensity Interval Training Versus Moderate Continuous Training in Multimodal Prehabilitation for Colorectal Surgery: A Randomized Controlled Trial.
Brief Summary: Surgery is a stressful procedure associate with perioperative physical impairment. In a previous study, the investigators showed that physical fitness could be optimize in surgical patients using prehabilitation, a preoperative conditioning intervention in form of exercise, nutrition and relaxation technique. The best modality of exercise has yet to be known.The purpose of this study is to compare high interval (HIT) vs. moderate continuous intensity (MC) training, integrated in a prehabilitation intervention in colorectal surgical patients.


Options:
A: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)
B: Oxygen consumption (VO2) (4 weeks (before surgery))
C: Post operative complications (30 days after surgery)
D: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High-Intensity Interval Training Versus Moderate Continuous Training in Multimodal Prehabilitation for Colorectal Surgery: A Randomized Controlled Trial.
Brief Summary: Surgery is a stressful procedure associate with perioperative physical impairment. In a previous study, the investigators showed that physical fitness could be optimize in surgical patients using prehabilitation, a preoperative conditioning intervention in form of exercise, nutrition and relaxation technique. The best modality of exercise has yet to be known.The purpose of this study is to compare high interval (HIT) vs. moderate continuous intensity (MC) training, integrated in a prehabilitation intervention in colorectal surgical patients.


Options:
A: Anaerobic threshold prior to liver resection (4 weeks)
B: Oswestry Disability Index (ODI) (Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
C: six minute walk test (baseline, preop, 4 weeks, 8weeks postop)
D: Oxygen consumption (VO2) (4 weeks (before surgery))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Discontinuation of Antidepressant Medication in Primary Care Supported by Monitoring Plus Mindfulness-based Cognitive Therapy Versus Monitoring Alone.
Brief Summary: To investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and Mindfulness-Based Cognitive Therapy (MBCT) in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.


Options:
A: Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase (Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182))
B: recurrence of major depression by administering the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impressions Scale (CGI) every 4 weeks for 40 weeks (40 weeks)
C: Percentage of Participants With Depressive Recurrence After Time (t) in Days (Every Visit from Week 34 up to Week 86 (Maintenance Phase))
D: Number of patients who fully discontinued their antidepressant medication after 6 months. (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: MEDISTAR STUDY: Mediterranean Diet and Smoking in Tarragona and Reus
Brief Summary: Several studies have shown the influence of the eating pattern on lung function. However, the benefits of the Mediterranean diet (DiMet) in preventing pulmonary dysfunction are not well known.

Objective: To evaluate the effect of adherence to DiMet on the deterioration of lung function in smokers.

Methodology: Design: Controlled, parallel, multicenter, cluster-randomized clinical trial. Participants: 566 active smokers with a cumulative consumption of more than 10 packets a year, within 25 to 75 year-old age group, without previous respiratory disease and who agree with the conditions of the study and sign an informed consent . Scope: 20 Primary Care Centers managed by the Catalan Health Institutes in Tarragona that will be randomly assigned to a control or an intervention group (1: 1). Intervention: During 2 years a nutritional intervention will be carried out to increase adherence to DiMet based on: 1) annual visit of personalized nutritional education, 2) annual telephone contact for intervention reinforcement, and 3) computer access to a dietary block designed ad hoc. The control group will follow their usual diet style. All participants will receive advice to quit smoking. It will be evaluated: a) pulmonary function by forced spirometry and b) adherence to the DiMet with a questionnaire of 14 items and biological determinations. Statistical analysis: For intention to treat. The unit of analysis will be the individual smoker. Parameters of pulmonary function and adherence to the DiMet of both groups will be compared.

Expected results: DiMet prevents the appearance of altered lung function in smokers without previous respiratory pathology. Thus, DiMet will be key in pulmonary prevention, together with the fundamental recommendation of smoking cessation.


Options:
A: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
B: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
C: Change in lung function values in smokers without previous respiratory disease (2 years)
D: Continuous abstinence (Russell Standard) (Six months post quit date)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care
Brief Summary: The study harnessed the multidisciplinary expertise of our research team to develop a brief, computer-based, alcohol reduction intervention tailored for HIV/HCV co-infected women and evaluate its efficacy. The intervention, if effective, may be an efficient and cost-effective alcohol reduction strategy, that is scalable and can be readily disseminated and integrated in clinical care at other AIDS Centres in Russia to enhance women's health and reduce HIV/HCV transmission risk.


Options:
A: Post-intervention ASSIST screening score. (3 months)
B: Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. (Baseline and 6 months post-baseline)
C: Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months. (Both 3 months and 6 months (composite measure)); Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH (6 months)
D: Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative (3-, 6-, and 9-month post-baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Mindfulness Training on Emotion Regulation and Impulsivity
Brief Summary: Mindfulness training has proven to be a reliable treatment for patients with Borderline Personality Disorder (BPD).The present randomized-controlled study examines the effects of mindfulness training on emotion regulation and impulsitivy. In addition, fMRI data was collected pre and post intervention. 70 patients with BPD diagnosis were randomized to either mindfulness or interpersonal effectiveness skills training. Assessments were conucted pre-and-post-intervention.


Options:
A: Beck scale for suicidal ideation (six months)
B: Change in scores on Beck Scale for Suicidal Ideation (Baseline, post-therapy, 6 months and 12 months after therapy)
C: Reduced Self-harm (3 months)
D: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Mindfulness Training on Emotion Regulation and Impulsivity
Brief Summary: Mindfulness training has proven to be a reliable treatment for patients with Borderline Personality Disorder (BPD).The present randomized-controlled study examines the effects of mindfulness training on emotion regulation and impulsitivy. In addition, fMRI data was collected pre and post intervention. 70 patients with BPD diagnosis were randomized to either mindfulness or interpersonal effectiveness skills training. Assessments were conucted pre-and-post-intervention.


Options:
A: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)
B: N/A
C: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)
D: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Mindfulness Training on Emotion Regulation and Impulsivity
Brief Summary: Mindfulness training has proven to be a reliable treatment for patients with Borderline Personality Disorder (BPD).The present randomized-controlled study examines the effects of mindfulness training on emotion regulation and impulsitivy. In addition, fMRI data was collected pre and post intervention. 70 patients with BPD diagnosis were randomized to either mindfulness or interpersonal effectiveness skills training. Assessments were conucted pre-and-post-intervention.


Options:
A: CAPS-5 (Clinician Administered PTSD Scale) (12 months)
B: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)
C: The primary outcome variables are mental distress (GHQ12, SCL5 and MBI), student stress (PMSS) and subsequent work stress, subjective wellbeing (SWB), empathy (JPSE), mindfulness (FFMS) (9 years)
D: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Mindfulness Training on Emotion Regulation and Impulsivity
Brief Summary: Mindfulness training has proven to be a reliable treatment for patients with Borderline Personality Disorder (BPD).The present randomized-controlled study examines the effects of mindfulness training on emotion regulation and impulsitivy. In addition, fMRI data was collected pre and post intervention. 70 patients with BPD diagnosis were randomized to either mindfulness or interpersonal effectiveness skills training. Assessments were conucted pre-and-post-intervention.


Options:
A: The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 40 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 10 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 20 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 30 weeks)
B: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)
C: Parasuicidal behaviour (intermittent)
D: Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score (Baseline (Day 0) to Week 10)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean Delivery: A Randomized Controlled Trial
Brief Summary: A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.


Options:
A: Number of patients receiving study intervention (At time of delivery)
B: The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor. (2 hours)
C: The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. (up to 42 days after randomisation)
D: Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells (by hospital discharge or by 7 days postpartum, whichever is sooner)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta
Brief Summary: The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.


Options:
A: N/A
B: Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg (From time 0 (dosing) up to 240 hours post-dose)
C: AUC from time 0 to the last data point (Pre-Dose and up to 120 hours post dose)
D: Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for BAY 94-9027 (Pre-dose to 120 hours after the end of the infusion); Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for Adynovi (Pre-dose to 120 hours after the end of the infusion)

Answer: C