Nutritional and Metabolic Diseases

All Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Metabolic Diseases

Diabetes Mellitus

Congenital Abnormalities

Pregnancy Complications

Cerebrovascular Disorders

Endocrine System Diseases

Neurologic Manifestations

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Dietary intake converted into dietary pattern scores.

Dietary intake

Walter C. Willett, MD, DrPH

To study, prospectively, the association between dietary patterns and risk of health outcomes (cardiovascular, metabolic, endocrine, neurological, skeletal muscular, cancer) in cohort study of 116,671 women age 24 to 44 years at baseline in 1989 (the Nurses' Health Study II; NHS II).

Health status and lifestyle information was self-reported on a questionnaire at baseline, and on questionnaires distributed to participants biennially thereafter. Dietary intake data was collected in form of a comprehensive, 131-item food frequency questionnaire (FFQ), distributed among participants every four years. The response rate remained over 90%. Dietary data was validated using biomarkers, health status data using medical records.

Dietary pattern scores were derived from FFQs using cumulative average whenever possible from years preceding the outcomes.

Multivariable Cox proportional hazards models were used to evaluate associations between dietary pattern scores and health outcomes, except in case of pregnancy complications (such as gestational diabetes mellitus/GDM and hypertensive disorders of pregnancy/HDPs) where multivariable logistic regression models with generalized estimating equations, with an exchangeable working correlation structure to account for correlated outcomes between pregnancies.

Our analysis was based on a cohort of female registered nurses.

Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)

Necrosis of heart muscle secondary to prolonged ischemia.

Sudden death of brain cells due to lack of oxygen

Glucose intolerance with onset/first recognition during pregnancy

Pregnancy induced hypertension, toxemia/preeclampsia

Fragility fractures of common sites such as hip and wrist.

Physical function such as falls, walking, and self care

National Institutes of Health (NIH)

National Cancer Institute (NCI)

National Institute of Environmental Health Sciences (NIEHS)

Harvard School of Public Health (HSPH)

NHS II Principal Investigator; Professor of Epidemiology and Nutrition

Neoplasms

Brain Neoplasms

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Dexmedetomidine

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Intraoperative intravenous infusion of dexmedetomidine

Intraoperative intravenous infusion of 0.9% saline

Chun-Yu Wu, MD

Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In brain tumor resection craniotomy, it is proven to be effective in improving postoperative hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives postoperative pain. In addition, many animal experiments show that DEX inhibits the proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral focal ischemic region (penumbra). However, the neuroprotective effects were never investigated clinically in patients undergoing brain tumor resection surgery.

The Neuroprotective Effects of Dexmedetomidine During Brain Surgery

biomarkers related to neuroinflammation and neuronal injury, such as HMGB1 and GFAP

National Taiwan University Hospital

Coronary Artery Disease

Myocardial Infarction

Infarction

Heart Diseases

Ischemia

Coronary Disease

Myocardial Ischemia

Necrosis

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Platelet Aggregation Inhibitors

Micronutrients

Vitamins

Aspirin

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Trace Elements

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Antioxidants

Protective Agents

Tocopherol

Tocotrienol

Vitamin E (600 IU every other day) and aspirin (100 mg every other day)

Vitamin E (600 IU every other day) and placebo

Aspirin (100 mg every other day) and placebo

Participants will receive 100 mg of aspirin every other day.

Participants will receive 600 IU of vitamin E every other day.

Placebo

Julie Buring

The purpose of this study is to evaluate the effects of low-dose aspirin and vitamin E in primary prevention of cardiovascular disease and cancer in apparently healthy women.

BACKGROUND:

Various doses of aspirin have been shown to be effective in preventing thrombosis or vascular occlusion in several clinical conditions. Short-term studies have documented the efficacy of aspirin in preventing occlusion of saphenous vein bypass grants, preventing myocardial infarction in patients with unstable angina, preventing transient ischemic attacks and stroke in men with cerebral vascular disease, preventing occlusion of injured coronary arteries following transluminal angioplasty and aiding in reducing myocardial infarction and total mortality in patients receiving fibrinolytic therapy. Additionally, aspirin has been effective in the secondary prevention of myocardial infarction in subjects with known coronary artery disease. The results of the Physicians' Health Study, a large-scale primary prevention trial of aspirin in male physicians, have shown a decrease in myocardial infarction, a non-significant increase in cerebral vascular events, and no difference in overall mortality. However, few studies have addressed the efficacy of aspirin in vascular diseases in women, and it is possible that the risk to benefit ratio may be different in women. Specifically, there have been no large primary prevention trials in women, who are at risk of coronary heart disease, especially after menopause.

DESIGN NARRATIVE:

The Women's Health Study (WHS) is a randomized, double-blind, placebo-controlled trial using a 2x2 factorial design. The WHS is sponsored by both NHBLI (HL080467) and NCI (CA047988). Approximately 1.75 million female health professionals were contacted by mail to determine if they were suitable for inclusion in the study. A three-month run-in phase was performed to screen out those with poor compliance. Randomization, which began in February 1993 and ended in January 1996, was stratified on five-year age groups. A total of 39,876 participants were randomly assigned to either Vitamin E (600 IU every other day) or placebo; and to aspirin (100 mg every other day) or placebo. IN the 2x2 factorial design, women were randomly assigned to active aspirin and placebo vitamin E (n=9,968), placebo aspirin and active vitamin E (n=9,971), active aspirin and active vitamin E (n=9,966), or placebo aspirin and placebo vitamin E (n=9,971). A description of the characteristics of women in these 4 groups is provided in J Women's Health Gend Based Med 2000;9:19-27. In the main analyses, all women on active aspirin (n=19,934) were compared to women on placebo aspirin (n=19,942); and all women on active vitamin E (n=19,937) were compared to women on placebo aspirin (n=19,939).

As part of the initial trial, pre-randomization blood samples from 28,345 participants were frozen and stored for genetic analysis which has been supported by non-federal sources.

The primary endpoint is the reduction of the risk of all important vascular events (a combined endpoint of nonfatal myocardial infarction, nonfatal stroke, and total cardiovascular death) and a decrease in the incidence of total malignant neoplasms of epithelial cell origin. Secondary endpoints are the individual components of the combined endpoints. Compliance is measured by replies to a questionnaire sent out every year. The trial was completed in 2004 and results were published in 2005 (N Engl J Med 2005;352:1293-304; JAMA 2005;294:47-55; JAMA 2005;294:56-65).

Currently, women are being followed on an observational basis.

Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer

Women's Health Study of Low-dose Aspirin and Vitamin E in Apparently Healthy Women

National Heart, Lung, and Blood Institute (NHLBI)

Brigham and Women's Hospital

Professor of Medicine, Harvard Medical School

Aspirin(100 mg every other day)and placebo vitamin E

Aspirin Only

Placebo aspirin and vitamin E (600 IU every other day

Vitamin E Only

Aspirin (100 mg every other day) and vitamin E (600 IU every other day)

Aspirin + Vitamin E

Both Placebos

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Julie E. Buring

Major cardiovascular event

Stroke

Myocardial infarction

Cardiovascular death

Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)

Total invasive cancer

Cancer death

Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer

Overall Study

Central Nervous System Neoplasms

Nervous System Neoplasms

Anesthetics

All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used).

Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

Fluorescein Sodium

Cherlynn Basignani, BSN,RN,CCRC

Gabriella Anderson, BA, CCRC

Ravi Gandhi, MD

This study focuses on implementing Yellow 560 for the direct intraoperative visualization of Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop better treatment protocols, and improve the prognosis of a wide array of neurosurgical diseases. More specifically, for the patients who are undergoing surgical intervention for the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or in general residual lesion which must be corrected.

The research design is a prospective clinical study. All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). Surgery will continue with the aid of the Yellow 560 microscope with a minimum delay of 10 minutes after injection to reduce the amount of leakage of Fluorescein Sodium into the surrounding tissue.

Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

No other additional neurosurgical instruments will be used. Patients will be treated post-operatively with conventional adjunctive therapies and imaging as deemed necessary by the attending neurosurgeon for the evaluation of extent of surgery. Follow-up data (including post-operative images assessing outcomes and complications) will be collected on all patients on standard post-operative visits. Intra-operative films or recordings and all patient data may be saved and used according to HIPAA allowances.

Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

The main outcome measure of the study would be a comparison between patient pre-operative and post-operative images to evaluate the potential utility of using Fluorescein Sodium and the Yellow 560 microscope to aid in the treatment of intracranial tumors and vascular lesions.

AdventHealth

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Wounds and Injuries

Rare Diseases

Critical Illness

Pulmonary Disease, Chronic Obstructive

Kidney Failure, Chronic

Renal Insufficiency

Heart Failure

Neoplasm Metastasis

Liver Cirrhosis

Lung Neoplasms

Lung Diseases

Chronic Disease

Brain Injuries

Multiple Organ Failure

Neoplastic Processes

Respiratory Tract Diseases

Craniocerebral Trauma

Trauma, Nervous System

Fibrosis

Liver Diseases

Gastrointestinal Diseases

Disease Attributes

Lung Diseases, Obstructive

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Renal Insufficiency, Chronic

Shock

Chronic Graft Versus Host Disease

The 'Facilitator-Based Intervention' includes patient and family member subjects.

The 'Usual Care' arm includes patient and family member subjects.

Facilitators interact in person or by telephone with patients, family, and clinicians both during and following the patient's ICU stay for 3 months. In-person contacts include visits to patients' homes and/or care facilities; phone contacts include calls to patients, families and clinicians. Patients and families have access to facilitators through phone and email 5 days per week. Facilitators may attend clinic visits with patients. In addition to checking directly with patients/families during regular contacts, facilitators also access the electronic health record to ensure they have accurate information about appointments and treatment plans and to document key points for the clinical team. Facilitators encourage referral to inpatient or outpatient palliative care services when needs are identified.

Facilitator-Based Intervention

Ruth A Engelberg, PhD

This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.

The impact of critical illness is increasing due to an aging population as well as advances in effectiveness and availability of critical care. Critically ill patients and their families suffer a high burden of symptoms of depression, anxiety, and post-traumatic stress due, in part, to fragmented medical care that is often poorly aligned with their goals. Fragmented care includes numerous transitions for patients and families across clinicians and across settings, starting in the intensive care unit (ICU) and extending to acute care, skilled nursing facilities, or home. As illness progresses, patients and families struggle to navigate the spectrum of goals of care, to match their values and goals with treatments, to communicate their goals to their clinicians, and to make difficult medical decisions without letting unmet emotional needs interfere. Poor communication exacerbated by these transitions compounds an already stressful experience, causing distress to patients and their families. Taken together, these issues lead to ineffective communication during and after the ICU which can often result in high intensity "default" care that may be unwanted.

Using a randomized trial, this project aims to evaluate an innovative model of care in which ICU nurse facilitators support, model, and teach communication strategies that enable patients and families to secure care in line with their goals over an illness trajectory, beginning in the ICU and continuing into the community. Facilitators use communication skills, attachment theory, and mediation to improve: 1) patients' and families' self-efficacy to communicate with clinicians within and across settings; 2) patients' and families' outcome expectation that communication with clinicians can improve their care; and 3) patients' and families' behavioral capability through skill building to resolve barriers to effective communication and mediate conflict. Facilitators work with seriously ill patients and their families beginning with a critical care unit stay and following them over the course of three months.

The intervention's effectiveness will be measured with patient- and family-centered outcomes at 1-, 3-, and 6-months post-randomization. The primary outcome is family members' burden of symptoms of depression over the 6 months. The investigators also evaluate whether the intervention improves the value of healthcare by reducing healthcare costs while improving patient and family outcomes. Finally, investigators use qualitative methods to explore implementation factors (intervention, settings, individuals, processes) associated with improved implementation outcomes (acceptability, fidelity, penetration) to inform dissemination of this type of intervention to support patients and their families. This study aims to address key knowledge gaps while evaluating a methodologically rigorous intervention to improve outcomes for patients with serious illness and their families across the trajectory of care and the spectrum of goals of care.

Facilitating Communication Study

Evaluating Effectiveness of a Communication Facilitator to Reduce Distress and Improve Goal Concordant Care for Critically Ill Patients and Their Families: A Randomized Trial

Qualitative interviews after individual participation. Interviews will be guided by the Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation, including aspects of the intervention, inner and outer settings, individuals, and processes of care. Individual constructs within these domains were chosen to fit this specific intervention and context.

Qualitative interviews after individual participation. Interviews will also explore three key implementation outcomes (acceptability, fidelity, penetration) that will guide future dissemination of the intervention.

Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS), which has become standard for ICU and post-ICU studies. The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. HADS has been used in over 700 studies with evidence of reliability, validity and responsiveness among critically ill patients and their family.

Concordance between the care patients want and the care they are receiving will be measured with two questions from the SUPPORT study. The first defines patients' preferences: "If the patient had to make a choice at this time, would the patient prefer a course of treatment focused on extending life as much as possible, even if it means having more pain and discomfort, or would the patient want a plan of care focused on relieving pain and discomfort as much as possible, even if that means not living as long?" The second question assesses perceptions of current treatment using the same two options. The outcome is a dichotomous variable of whether the preference matches the report of care received. Although this creates a "false dichotomy" in that many patients want both, this "forced choice" helps identify patients' top priority. Based on prior studies, we expect only 50-60% of controls will report goal-concordant care. Items completed by family respondents.

The Impact of Event Scale-6 (IES-6), derived from the IES-R, uses 6 self-report items to assess subjective distress caused by a traumatic event. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely").

The Perceived Competence Scale (PCS) is a short, 4-item questionnaire assessesing participants' feelings of competence. Items can be worded differently for different target behaviors. Validity was established in a study of medical students, and then in studies of diabetes self-management. Cronbach's alpha has consistently been above 0.80 in multiple studies. The scale has been used in several studies.The mean of 4 items is used as the scale score. The 4 items have also been used to form a latent variable, and assessed for change over time. Responses range from "Not at all true" (1) to "Very True" (7); higher score on the latent variable would indicate greater competence.

We will measure hospital readmission after initial hospital discharge through the electronic health record (EHR), institutional billing systems and, patient/family self-reports. All hospitals are in one system facilitating data collection. By using all three sources for data, we will capture hospitalizations regardless of healthcare system. Our primary focus will be readmission within 30 days as this is a national standard, but we will also collect data from the EHR and from patient/family interviews to record all readmissions, emergency department visits, clinic visits, inpatient and outpatient palliative care consults, and home care over 6 months. All occasions of healthcare use will be confirmed through chart review and valued using the Medical Expenditure Panel Survey and the Healthcare Cost and Utilization project, with additional information from institutional financial systems, to capture costs of care rather than charges.

Family member assessment of perceived financial stress will be measured with the 11-item COST instrument which has demonstrated reliability and validity in measuring financial toxicity.

Measure of family experience of patients with serious illness. The QUAL-E (Fam) is a validated \~17-item companion instrument to the patient QUAL-E measure of quality of life at the end of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)	NCT03328546	Cardiovascular ... Cerebrovascular... Metabolic Disea... Neoplasms Endocrine Syste... Neurologic Symp... Skeletal Anomal... Diabetes Mellit... Pregnancy Compl...	Dietary intake	24 Years - 44 Years	Harvard School of Public Health (HSPH)
The Neuroprotective Effects of Dexmedetomidine During Brain Surgery	NCT02878707	Brain Tumor Cerebrovascular...	Dexmedetomidine	20 Years - 80 Years	National Taiwan University Hospital
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer	NCT00000479	Cardiovascular ... Cerebrovascular... Coronary Diseas... Heart Diseases Myocardial Infa... Myocardial Isch... Vascular Diseas...	Aspirin Vitamin E Placebo	45 Years -	Brigham and Women's Hospital
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions	NCT02478346	Cerebrovascular... Intracranial Ne...	Fluorescein Sod...	18 Years -	AdventHealth
Facilitating Communication Study	NCT03721952	Chronic Disease Neoplasm Metast... Lung Neoplasm Pulmonary Disea... Heart Failure, ... Liver Cirrhosis Kidney Failure,... Multiple Organ ... Health Care Qua... Intensive Care ... Palliative Care... Palliative Care... Lung Diseases Cerebrovascular... Brain Injuries	Facilitator-Bas...	18 Years -	University of Washington
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer	NCT00000479	Cardiovascular ... Cerebrovascular... Coronary Diseas... Heart Diseases Myocardial Infa... Myocardial Isch... Vascular Diseas...	Aspirin Vitamin E Placebo	45 Years -	Brigham and Women's Hospital

Spots Global Cancer Trial Database for cerebrovascular disorders