TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: DOMUS: A Randomized Controlled Clinical Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
Brief Summary: Danish studies have shown that the majority of palliative cancer patients wish to be cared for and spend the rest of their lives at home. Nevertheless \> 50% of palliative cancer patients die in acute hospitals and these figures are found in countries with a highly developed palliative care service as well. Some studies have suggested that, among other causes, delays in the discharge process represent a significant obstacle for achieving care and treatment, and ultimately death at home. Therefore, this randomized controlled trial (RCT) aims at investigating an accelerated transition program from oncological treatment to continuous specialized palliative care at home for patients with incurable cancer. The primary objective of the study is to investigate whether an accelerated transition from oncology care to palliative home care significantly increases home care and death. The secondary objectives are to investigate whether the intervention improves symptom control and quality of life, increases survival, affects health care expenses, improves caregiver quality of life and burden, dyadic coping and grief outcomes. The study will take place in the departments of oncology at Rigshospitalet, where palliative cancer patients will enter the intervention or usual care arms. The intervention is an accelerated transition program, which consists of planning palliative home care and if needed optimization of facilities at home, and a transfer to home care within 5 days of informed consent. On day 1 at home the patient, informal caregiver, nurse, representatives of the specialized palliative care team and if possible the general practitioner and project psychologist meet to organize home care. A dyadic psychological intervention is offered to patients and their informal caregiver during specialized palliative care at home and to bereaved caregivers. The control group will be treated according to the usual principles, but if inadequate palliative care is observed in this group, the study group is obliged to involve responsible professionals. Both groups will be followed by assessments of the patient and the caregiver for up to 6 months and the caregivers 19 month after the patient's death.


Options:
A: Change in Score on the Edmonton Symptom Assessment for patients (At baseline and 1- and 2- months following baseline); Change in Score on Hospital Anxiety and Depression Scale (HADS) for patients (At baseline and 1- and 2- months following baseline)
B: Healthcare utilization (up to 12 months)
C: Place of care and death (Up to 4.5 years)
D: changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks (baseline and after 4, 16 and 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DOMUS: A Randomized Controlled Clinical Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
Brief Summary: Danish studies have shown that the majority of palliative cancer patients wish to be cared for and spend the rest of their lives at home. Nevertheless \> 50% of palliative cancer patients die in acute hospitals and these figures are found in countries with a highly developed palliative care service as well. Some studies have suggested that, among other causes, delays in the discharge process represent a significant obstacle for achieving care and treatment, and ultimately death at home. Therefore, this randomized controlled trial (RCT) aims at investigating an accelerated transition program from oncological treatment to continuous specialized palliative care at home for patients with incurable cancer. The primary objective of the study is to investigate whether an accelerated transition from oncology care to palliative home care significantly increases home care and death. The secondary objectives are to investigate whether the intervention improves symptom control and quality of life, increases survival, affects health care expenses, improves caregiver quality of life and burden, dyadic coping and grief outcomes. The study will take place in the departments of oncology at Rigshospitalet, where palliative cancer patients will enter the intervention or usual care arms. The intervention is an accelerated transition program, which consists of planning palliative home care and if needed optimization of facilities at home, and a transfer to home care within 5 days of informed consent. On day 1 at home the patient, informal caregiver, nurse, representatives of the specialized palliative care team and if possible the general practitioner and project psychologist meet to organize home care. A dyadic psychological intervention is offered to patients and their informal caregiver during specialized palliative care at home and to bereaved caregivers. The control group will be treated according to the usual principles, but if inadequate palliative care is observed in this group, the study group is obliged to involve responsible professionals. Both groups will be followed by assessments of the patient and the caregiver for up to 6 months and the caregivers 19 month after the patient's death.


Options:
A: Dyad Congruence on Goals-of-Care Tool (Baseline, Week 2); Patient's Decisional Conflict Scale (DCS) Score (Baseline, Week 2); Surrogate's Decision Making Confidence (DMC) Scale Score (Baseline, Week 2); Composite Outcome of Dyad Congruence and Surrogate DMC Score (Baseline, Week 2)
B: Place of care and death (Up to 4.5 years)
C: quality of communication (1 month after intervention completed)
D: Aim 1: feasibility and acceptability of learning Motivational Interviewing techniques by palliative care clinicians (Through study completion, an average of 1 year.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-Invasive Ventilation (NIV) For Positive Pressure Support. A Randomised Cross-Over Trial To Evaluate The Short-Term Effects of NIV As An Adjunct To Airway Clearance Techniques in Adults With Cystic Fibrosis.
Brief Summary: Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes which is characterised by the production of thickened bodily secretions, affecting the function of organs such as the pancreas and the lungs. Within the lungs, thickened sputum is very difficult to clear, which can results in recurrent chest infections, which can lead to lung damage. therefore it is important to optimise the removal of sputum to try and prevent these complications. Traditionally, a variety of approaches are usually combined including inhaled medications to thin or hydrate secretions, and chest physiotherapy to mobilise secretions and improve sputum clearance.

There are many chest physiotherapy or airway clearance techniques (ACT) available including breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest Oscillation (the "Vest"), or oscillatory devices such as the Flutter or Acapella. When people with CF have an infection or have severe disease often the effectiveness of ACTs can decrease due to fatigue, shortness of breath or having an overwhelming amount of sputum. At this time it is necessary to re-assess ACTs and the addition of positive pressure to airway clearance techniques has been shown to be helpful in decreasing fatigue during chest physiotherapy.

At present no research studies have reported an increase in sputum cleared with the addition of positive pressure, however it is thought that the ability to take a deeper breath when using positive pressure would help to improve sputum clearance. With clinical experience of the use of NIV with adult CF patients, the investigators aim to explore this objectively in this study.

Research Question:

Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive pressure to normal airway clearance techniques improve sputum clearance in stable adult patients with cystic fibrosis?

Hypothesis

The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance technique will lead to improvements in subjective ease of clearance and work of breathing during airway clearance and objectively increase sputum clearance, as well as being well tolerated in patients as an adjunct to airway clearance.


Options:
A: weight of sputum that was expectorated (12 months)
B: Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight (24 hours)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Wet sputum production (45 minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2 Double-Blind Study of the Safety and Efficacy of Albuterol on Motor Function in Individuals With Late-onset Pompe Disease Receiving Enzyme Replacement Therapy
Brief Summary: In this study the study team proposes to investigate the efficacy of albuterol on motor function of individuals with Late Onset Pompe Disease (LOPD) who are receiving enzyme replacement therapy, given albuterol was well-tolerated in patients with Late Onset Pompe Disease.


Options:
A: Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0 to 2.5 years); Baseline Values (Week 0) of Functional Endurance as Measured by Six-Minute Walk Test (6MWT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0); Change From Baseline (Week 0) in the Six-Minute Walk Test (6MWT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0, Week 104); Baseline Values (Week 0) for Percent Predicted Forced Vital Capacity (FVC) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0); Change From Baseline (Week 0) in the Percent Predicted Forced Vital Capacity (FVC) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0, Week 104)
B: Change From Baseline to Week 52 in 6 Minute Walk Distance (6MWD) (Baseline, Week 52)
C: Summary of Patients Reporting Treatment-Emergent Adverse Events (weeks 0-78); Mean Distance Walked as Measured by Six-minute Walk Test (6MWT) at Weeks 0 and 78, and Mean Change From Baseline (weeks 0, 78); Percent of Predicted Forced Vital Capacity (FVC) (weeks 0, 78); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Area Under the Curve (AUC) (weeks 0, 12 and 52); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Maximum Plasma Concentration(Cmax) (weeks 0, 12, 52); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Time to Maximum Plasma Concentration(Tmax) (weeks 0, 12, 52)
D: Number of Participants With Adverse Events. (52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RECALL: Retaining Cognition While Avoiding Late-Life Depression
Brief Summary: This study will adapt Problem Solving Therapy (PST) for individuals with mild cognitive impairment (MCI) as an intervention for preventing major depression (DEP). PST will be modified so as to be provided to both MCI probands as well as their support person. The primary aim is to examine the effectiveness of PST in individuals with MCI and the support person, at preventing DEP over 12 mos. in MCI probands. We also will examine the effect of exercise on preventing depression.


Options:
A: Montgomery Asberg Depression Scale (MADRS) (12 week outcome); WHO Disability Assessment Schedule (WHODAS)-II (12-week outcome)
B: Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R) (24 months)
C: Change from baseline in Geriatric Depression Scale (GDS) (Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up)
D: Incidence of depression or anxiety disorders (15 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (&gt;/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)
Brief Summary: This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.


Options:
A: Progression Free Survival (PFS) (Time from study entry to the time of documented disease progression or death. The analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years.)
B: Progression-free Survival (PFS) Rate at 3 Years (Assessed every 3 months until progression up to 4 years and 8 months)
C: Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) (Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021))
D: Progression Free Survival (PFS) (Up to 2 years 10 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Nasal High Flow Oxygen Therapy for Prevention of Postoperative Hypoxemia After Abdominal Surgery: A Multicenter Randomized Controlled Trial
Brief Summary: To evaluate whether early application of nasal high flow oxygen therapy after extubation can reduce the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio \<300) after abdominal surgery in patients with intermediate to high risk of postoperative pulmonary complications.


Options:
A: percentage of patients who developed postoperative hypoxemia (defined as PaO2/FiO2 ratio <300) (1 hour after tracheal extubation (day 1))
B: The decrease of diaphragmatic workload (thickening fraction of the diaphragm) (30 minutes)
C: All-cause day-28 mortality (28 days)
D: Arterial partial pressure of carbon dioxide (PaCO2) (2 hours after randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Nasal High Flow Oxygen Therapy for Prevention of Postoperative Hypoxemia After Abdominal Surgery: A Multicenter Randomized Controlled Trial
Brief Summary: To evaluate whether early application of nasal high flow oxygen therapy after extubation can reduce the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio \<300) after abdominal surgery in patients with intermediate to high risk of postoperative pulmonary complications.


Options:
A: Failure of the ventilation system (One week)
B: percentage of patients who developed postoperative hypoxemia (defined as PaO2/FiO2 ratio <300) (1 hour after tracheal extubation (day 1))
C: The decrease of diaphragmatic workload (thickening fraction of the diaphragm) (30 minutes)
D: Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer (during the first 96 hours after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program in Patients With Acute Myocardial Infarction
Brief Summary: The aim of this study was to investigate the effects of electric stimulation (electrolipolysis) in a home-based cardiovascular rehabilitation program in patients with acute myocardial infarction


Options:
A: Cardiorespiratory Fitness (Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Home-based Program); Blood tests (Change from Baseline in blood tests at 8 weeks of Cardiac Rehabilitation Home-based Program); Computerized axial tomography (Change from Baseline in Computerized axial tomography at 8 weeks of Cardiac Rehabilitation Home-based Program)
B: The primary-endpoint is empowerment to reach self-care goals after 5 years (At baseline and after 5 years)
C: Peripheral blood gene expression (baseline); Peripheral blood gene expression (6wks after starting 12week exercise training (or conventional care)); peripheral blood gene expression (12 weeks after exercise training (or conventional care)); Peripheral blood gene expression (24 weeks after starting 12 weeks exercise training programme)
D: exercise capacity as reported in total time on the exercise test using the BRUCE protocol (16 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Donepezil for REM Enhancement and Behavioral Change in Autism
Brief Summary: Background:

- Some children with autism spectrum disorders (ASD) do not have normal sleep cycles. Some of these children spend very little time in the rapid eye movement (REM) stage of sleep. Some studies suggest that less time in REM sleep can be associated with learning and behavior problems. Donepezil is a medication used to treat Alzheimer s disease. Donepezil can increase REM sleep in some adults with different disorders. A small study showed that Donepezil can also increase REM sleep in children with ASD. Researchers now want to see if Donepezil can improve communication skills and social interaction in children with ASD. They also want to see if any change in symptoms seems to come from changes in REM sleep.

Objectives:

- To see if a medication, Donepezil, can improve the way communication skills and social interaction develop in young children with autism spectrum disorders.

Eligibility:

- Children 22 to 44 months of age with ASD.

Design:

* Participants will be screened with a blood test, heart tests, and a sleep study. During the sleep study, children will sleep in a darkened room for 2 nights with electrodes on their body and a tube under their nose. Parents can sleep in the room with their child. A technician will monitor the room all night.
* Participants will take the study medication once a day.
* Treatment will be monitored at visits every 3 months. At each visit the participant will take blood tests, heart tests, or behavior tests. Participants will have 2 more sleep studies.
* Participation will end after 18 months.


Options:
A: Children's Psychiatric Rating Scale (Weekly)
B: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)
C: Nonverbal Developmental Quotient (NVDQ) (Baseline and 12 months)
D: Clinical Global Improvement (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telecare in Adults With Type 1 Diabetes Mellitus Treated by Insulin Pump - A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether Telecare can be used for efficient management of adults with Type 1 Diabetes Mellitus using insulin pump, in lieu of frequent clinic visits.


Options:
A: Cardiovascular events (5 years of follow up)
B: Change in HbA1c (6 months)
C: Change in Glycosylated Hemoglobin (Hba1c) (From date of randomization every 3 months, up to one year)
D: Change From Baseline in Glycosylated Hemoglobin (%) (Baseline to 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
Brief Summary: This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study was to see if Roxadustat is both effective and safe as a treatment for anemia in patients with chronic kidney disease.


Options:
A: Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response (Baseline to week 24); Hb Change From Baseline (BL) to the Average Hb in Weeks 28-52 Regardless of Rescue Therapy (Baseline and weeks 28 to 52)
B: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period (Baseline and week 12 to 16)
C: Mean Hb (Hemoglobin) level (From week 30 to 36); Change in hemoglobin level from baseline to the average during the evaluation period (Baseline and week 30 to 36)
D: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period: Non-inferiority Analysis (Up to 3.9 person-years for CV follow-up time period); Mean Change From Baseline in Hemoglobin (Hgb) Levels During Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Japanese, Phase 2, Multicenter, Randomized, 4-arm Parallel, Double-blind (Arms 1-3), Open-label (Arm 4), Active-comparator (Darbepoetin Alfa) Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis-dependent Chronic Kidney Disease Patients With Anemia
Brief Summary: This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia.


Options:
A: Change From Baseline in Hemoglobin (Hgb) at Week 4 (Baseline (Week -4, Week-2 and Day 1) and Week 4)
B: Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))
C: Rate of rise in hemoglobin (g/dL/week) (Baseline and at Week-6)
D: Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) (Day 1 to Day 42)

Answer: C