Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Digestive System Diseases

Rare Diseases

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Malnutrition

Acquired Immunodeficiency Syndrome

HIV Infections

Inflammatory Bowel Diseases

Intestinal Diseases

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Gastrointestinal Diseases

Gastroenteritis

Nutrition Disorders

Chronic Graft Versus Host Disease

Control: high-energy ONS 1.5 Kcal/m 200ml for 90 days

Intervention: high-energy ONS 1.5 Kcal/m 200ml for 90 days

Fortimel

Natalia Iglesias, MD

Alfonso Calañas, MD

Pedro L Pablos Velasco, MD

Araceli Ramos, MD

Pedro Pablo Garcia Luna, MD

Daniel Antonio De Luis Román, MD

This study aims to compare nutritional outcomes in terms of percentage of weight gain between a new planted-based high-energy ONS and a standard high-energy ONS with animal protein (cow's mil protein) in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria.

Due to the increasingly pressing need to develop an oral nutritional supplement (ONS) that does not contain animal ingredients, Fortimel PlantBased, suitable for patients with Disease-Related Malnutrition or who wish to avoid or reduce the consumption of animal products for dietary or lifestyle reasons, is being promoted. At the same time, it is also a therapeutic option to be considered in the population with allergy or intolerance to cow's milk protein. Therefore, the aim is to offer an adapted therapeutic nutritional solution that guarantees nutritional results that are not inferior than ONS with animal protein (cow's milk protein).

This study was designed as an open-label randomized controlled non-inferiority trial with two arms: a new planted-based ONS (Fortimel PlantBased) as the intervention arm and standard ONS (Fortimel Energy) as the control arm, both high-energy formulas (1.5 kcal/m; 200ml).

The study will be carried out in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria, who need to supplement their diet by taking a high-energy ONS for at least 12 weeks. These patients will be treated and follow-up by the Endocrinology and Nutrition services of 6 public hospitals in Spain.

Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients

Improvement in nutritional status according to the GLIM criteria. A change in classification category from grade 2 of malnutrition to grade 1 or not meet GLIM criteria, as well as a change from grade 1 to not meet GLIM criteria are considered an improvement.

Taking into account the number of bottles per day taken, the ml of product and the ml left over.

Patients satisfaction taking ONS will be considered if a patient indicates a score of at least 8 points for overall satisfaction question.

Danone Specialized Nutrition

Neoplasms

Diseases and Abnormalities at or Before Birth

Syndrome

Lung Neoplasms

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Pulmonary Emphysema

Emphysema

Acute Lung Injury

Bronchitis

Bronchitis, Chronic

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

Subjects who provide informed consent and meet the eligibility criteria will have 50 ml of blood collected and sent to Freenome or Freenome's designee for processing, testing, and storage, and will then complete a standard-of-care screening LDCT.

blood draw

April Allison, BS

Harris Naemi, BS / Joye Choy, BS

Study Coordinator

Chuanbo Xu, PhD

Nasibeh Vatankhah, MD

The PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine, standard-of-care screening Low-Dose Computed Tomography (LDCT).

This is a prospective, multi-center, observational study to evaluate the performance of the Freenome Multiomics Blood Test in screening eligible participants for lung cancer.

Enrollment will be open to all eligible participants for screening chest CT scan as part of the Standard of Care (SOC) for lung cancer. Subjects who meet the eligibility criteria for this study and provide informed consent will be enrolled and blood sample collection must be completed within 30 days of signing the informed consent. Optimally, the screening chest CT will be completed on the same day of the study blood collection, however up to 45 days will be allowed after study blood collection to obtain a screening chest CT.

The study will also collect demographic data and relevant clinical data, such as medical history, lifestyle, occupational and environmental exposure(s), family history, and clinical laboratory data. All reports and clinical notes regarding the diagnostic tests and procedures related to lung cancer diagnosis or lung lesion assessment, such as histopathology and bronchoscopy reports, and diagnostic/follow-up images and imaging reports will be collected as part of follow up to the screening chest CT scan.

All enrolled subjects will be followed prospectively from the date of the baseline screening chest CT until a minimum of 24 months, or until a premature study endpoint inclusive of withdrawal of consent or death.

Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome Multiomics Blood Test

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)

Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 12-month follow-up period

Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 24-month follow-up period

Freenome Holdings Inc.

Giulia Veronesi, MD

Federica Cioffi

This project aims to implement a health prevention program for smokers or former smokers including early detection of lung cancer, cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD). The clinical activity is completed by a pre-clinical evaluation of molecular bio-markers of early diagnosis of these diseases, with the aim of strengthening the sensitivity and specificity of the screening program.

The project also includes a cost-effectiveness assessment to validate the feasibility of the program.

Since lung cancer, CVD and COPD are among the deadliest smoking-related pathologies, the program includes actions aimed at raising awareness among primary care physicians, increasing the smoking cessation rate of participating subjects to improve quality of life.

Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention

Subjects with increased risk for lung cancer, selected through an epidemiological questionnaire, sign the informed consent and their blood is collected. They then undergo LDCT and an interview at the anti-smoking center. CTs presenting with at least one non-calcified nodule are managed according to dedicated diagnostic algorithm. Nodules indicative of lung cancer will be studied with preoperative diagnosis, with surgical resection preferably performed with a minimally invasive approach. Multimodality treatment is indicated in advanced stage of disease. Subjects with normal findings are scheduled for annuals CT scan for two additional years. Cardiovascular risk will be assessed with the use of the atherosclerotic cardiovascular disease (ASCVD) score, recommended by the American College of Cardiology/American Heart Association, integrated with Reynold risk score and CAC score. The CAC score, calculated on LDCT, is used to quantify the presence of calcium through the coronary system.

Ten ml of blood is collected before LDCT, for plasma and white blood cells. For lung cancer patients, blood is collected before treatment, at 1-6-12 months after treatment, to analyse markers for minimal residual disease or early recurrence.

We will perform:

* CTC identification and genomic analysis. Patients are considered CTCs positive based on cytopathology of the isolated cells and detection of characteristic malignant features.
* Evaluation of Serum of PTX3, measured with an original sandwich enzyme-linked immunosorbent assay (ELISA)
* Circulating microRNA profiling. A custom panel of 6 specific microRNAs identified in a previous study on Karolinska cohort and correlating with increase/reduction risk of CVD Mayor adverse cardiovascular events MACE will be tested in 2000 patients.
* IL-2, IL-8, CRP, IL-5 and Eosinophils analyses. Interleukin-2 and-8, C-reactive protein, interleukiine-5 and eosinophils concentrations in blood are measured with ELISA kits.

Cost-benefit analysis of the prevention program. Direct and indirect costs associated with diagnosis and treatment of smoking-related diseases will be compared to those of a control group with disease detected after the appearance of pulmonary symptoms. The incremental cost effectiveness ratio will be evaluated in terms of QUALYS (quality of life adjusted years saved).

Ospedale San Raffaele

Istituto Clinico Humanitas

Heart and Blood Diseases

Death

Heart Failure

End Stage Liver Disease

Liver Diseases

Heart Diseases

Liver Failure

Hepatic Insufficiency

The training program will assign resident or NP student to a rotation. They will be receiving the educational intervention during 8 half-day sessions.

Resident or NP student is assigned to usual education.

Resident or NP Student receives the educational intervention during 8 half-day sessions.

Training Program Intervention

J. Randall Curtis, MD, MPH

This research study is a randomized trial to evaluate a training program that is designed to improve the communication skills of clinicians. The training program focuses on care for patients with serious illnesses and their family members, and assesses effectiveness using patient and family outcomes. The long term goal of this research is to improve communication skills of doctors and nurses, thereby improving patient and family outcomes.

Three decades of research on end-of-life care in the United States indicates that people who are dying often spend their final days with a significant burden of pain and other symptoms and receive care they would not choose. Patient-clinician communication about end-of-life care is an important focus for improving patient-centered end-of-life care for three reasons: 1) it is an integral component of clinician skill that affects all other aspects of end-of-life care; 2) physicians and nurses in practice do not demonstrate adequate skills for communicating about end-of-life care; and 3) current training in end-of-life communication is inadequate. Studies have shown that clinicians can improve their communication skills with experiential training, but no studies to date have shown that an intervention to improve clinician communication skill improves patient outcomes. Furthermore, despite widespread knowledge that end-of-life care is best delivered in an interdisciplinary context, most studies do not incorporate interdisciplinary training that includes physicians and nurses.

This is a randomized trial of a communication skills workshop for internal medicine residents and nurse practitioner (NP) students. A total of 373 residents and 128 NP students from two large training programs (UW and MUSC) will be randomized to either the intervention or usual education. The study's primary outcome measure will be the QOC scores on the "communication about end-of-life care" domain. The QOC will be assessed by patients, family members, and nurses before and after the intervention time period for all trainees. Secondary outcome measures are patient symptoms and patient-, family - and nurse-assessed QEOLC scores. Outcome measures will be collected for 5 patients and family members per trainee before the intervention period and 5 patients and family members per trainee after the intervention period. Process measures for both residents and NP students will include pre- and post-intervention assessment of knowledge, attitudes, and behavior regarding communication using standardized patient assessment as well as self-assessment and faculty assessment.

Improving Clinician Communication Skills (ICCS)

Improving Patient Outcomes in End-of-Life Care Provided by Physicians and Nurses

National Institute of Nursing Research (NINR)

University of Washington

Professor of Medicine

Behaviors and Mental Disorders

Kidney Diseases

Kidney Failure, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Insufficiency, Chronic

Quality of Life

Subjects in the first group ("Life Completion") completed a psychosocial intervention which consisted of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.

The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.

Subjects in the third group ("treatment as usual") were exposed to no intervention or attention control during the intervention window.

Subjects discussed life review, issues of forgiveness and heritage and legacy.

Life Completion

Subjects listened to a non-guided relaxation CD

Attention Control

Karen E. Steinhauser, PhD

The purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.

This is a randomized control trial to evaluate the feasibility of the Outlook intervention. 221 veterans with advanced cancer, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or end stage renal disease (ESRD) were randomly assigned to one of three intervention groups and completed a brief battery of pre-test measures. Subjects in the first group ("Outlook Intervention") were randomized to meet with a facilitator three times for a period of 45 min-1 hour. Participants were asked in the first session to discuss issues related to life review. They were asked in the second session to speak in more depth about issues of regret, forgiveness and things left undone. The subject of the final session was heritage and legacy. Participants in the attention control group were randomized to meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation audio disc (CD). Participants in the third group ("treatment as usual") were exposed to no interventional sessions. Participants were assessed with post-test measures administered by a blinded interviewer one week and 3 weeks after the intervention window.

Outlook Quality of Life Intervention Study

Outlook: An Intervention to Improve Quality of Life in Serious Illness Study

Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 4-item preparation sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 5 and maximum was 20 with higher numbers indicating higher preparation.

Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 7-item life completion sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 7 and maximum was 35 with higher scores indicating greater completion.

The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 0-20. Higher scores indicate greater anxiety.

Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.

The Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (Facit-SP) is a 12-item measure of faith, meaning and purpose, with a range of 0 to 48. Higher scores indicate greater spiritual well-being.

Functional assessment of Cancer Therapy-General) is a 27 item survey which assesses physical, social/family, emotional, and functional well being. This sub-scale assesses social well-being. We omitted an item assessing satisfaction with sex life, due to high missing data. Items are rated on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating, "very much" in response to item questions. Total sub-scale range is 0 to 30, with higher scores indicating better well-being.

VA Office of Research and Development

Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.

Subjects in the first group ("Life Completion") will complete a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.

Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy.

Outlook Intervention

The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.

Subjects in the third group ("treatment as usual") will be exposed to no intervention or attention control during the intervention window.

Treatment as Usual

Subjects in the first group ("Outlook Intervention") completed a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on issues of heritage and legacy.

Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy.

Arm 1 -Outlook Intervention

The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.

Attention Control: Subjects will listen to a non-guided relaxation CD

Arm 2 Attention Control

Subjects in the third group ("Treatment as Usual") were exposed to no intervention or attention control during the intervention window.

Arm 3 Treatment as Usual

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

High (greater or = 70)

Low (less or = 60)

The Palliative Performance Scale was used to assess functional status of participants. It was used as a stratification variable in randomization to assure that all arms of the trial had equal numbers of participants at similar levels of functional abilities, and illness severity. Scale range is 0 -100 where higher numbers indicate higher function.

Palliative Performance Scale - Stratification variable

Less than High School (HS) degree

HS degree or GED

Some college, associate, trade school

Bachelor's degree

some graduate/professional or higher degree

Highest level of Education

Christian

Other

Not a member of a religion

Missing

Religion

Difficulty paying the bills

Money to pay bills but need to cut back

Pay bills but little spare money

Have enough money for special things

Financial Status

Working for pay, part or full-time

Not working

Retired

Disability

Working Status

A total of 261 Durham VAMC patients with serious life-limiting disease were consented, and 221 were randomized to the study. Seventy-five were randomized to the Life completion intervention, 74 to the active control intervention, and 72 to the usual care control group.

Karen Steinhauser, PhD

Baseline mean

5 week follow up

7 week follow up

Participants received the Outlook Intervention

Participants received a relaxation meditation as attention control

Participants received no intervention, but rather care as usual

QUAL-E - Preparation Sub-scale

Baseline

5 Weeks

7 Weeks

Participants received the Outlook intervention

Participants received a relaxation meditation as attention control condition.

Participants received no intervention but rather care as usual.

POMS Anxiety Sub-scale

5 week

7 Week

Participants received a relaxation meditation as the attention control condition.

Participants did not receive any intervention but rather care as usual.

Arm 3 Usual Care

CES-D

Baselin

Participants received a relaxation meditation as the attention control condition

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients	NCT06055543	Malnutrition Cancer Inflammatory Bo... Chronic Obstruc... Hiv	Fortimel	18 Years -	Danone Specialized Nutrition
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening	NCT06122077	Lung Cancer Dia...	blood draw	50 Years -	Freenome Holdings Inc.
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients	NCT06055543	Malnutrition Cancer Inflammatory Bo... Chronic Obstruc... Hiv	Fortimel	18 Years -	Danone Specialized Nutrition
Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention	NCT04315766	Lung Cancer Cardiovascular ... Chronic Obstruc...		55 Years -	Istituto Clinico Humanitas
Improving Clinician Communication Skills (ICCS)	NCT00687349	Advanced Cancer Chronic Obstruc... Restrictive Lun... Congestive Hear... End Stage Liver...	Training Progra...	18 Years -	University of Washington
Outlook Quality of Life Intervention Study	NCT01044290	Cancer Congestive Hear... Chronic Obstruc... End Stage Renal...	Life Completion Attention Contr...	18 Years - 95 Years	VA Office of Research and Development
Patient-Centred Innovations for Persons With Multimorbidity - Quebec	NCT02789800	Hypertension Depression Anxiety Musculoskeletal... Arthritis Rheumatoid Arth... Osteoporosis Chronic Obstruc... Asthma Chronic Bronchi... Cardiovascular ... Heart Failure Stroke Transient Ische... Ulcer Gastroesophagea... Irritable Bowel Crohn's Disease Ulcerative Coli... Diverticulosis Chronic Hepatit... Diabetes Thyroid Disorde... Cancer Kidney Disease Urinary Tract P... Dementia Alzheimer's Dis... Hyperlipidemia HIV	DIMAC02	18 Years - 80 Years	Université de Sherbrooke
Improving Clinician Communication Skills (ICCS)	NCT00687349	Advanced Cancer Chronic Obstruc... Restrictive Lun... Congestive Hear... End Stage Liver...	Training Progra...	18 Years -	University of Washington

Spots Global Cancer Trial Database for chronic obstructive pulmonary disease (copd)