cyrilzakka/clinical-trials huggingface dataset:
Underutilization of Hospice in Older African Americans

Despite the documented benefits of hospice, less than 2 million people utilize hospice services annually. Underuse disparities are extreme across race and ethnicity as White Americans comprise 85% of all hospice enrollees. AAs account for only 8% of hospice enrollees but are more likely to die from the top three hospice diagnoses (i.e. cancer, heart disease and dementia) than White Americans. Even when AAs enroll in hospice, they spend less time in hospice than White patients, averaging fewer than seven days in hospice care. Notably, AA hospice enrollees report a higher degree of satisfaction with end of life care when hospice is involved, as compared to AAs who are not enrolled in hospice care. There are several potential barriers that may prevent AAs from enrolling in hospice care including lack of knowledge of hospice care, mistrust in healthcare, perceived discrimination, health literacy. AAs routinely report less knowledge of hospice than White Americans, and the information that AA know about hospice often comes from non-medical professionals and is inaccurate. Some AA have persistent mistrust in healthcare due to events such as the Tuskegee Syphilis Experiments and many AA perceive discrimination when accessing healthcare. Data shows that health literacy is a stronger predictor of hospice use than race and older AAs are more likely to possess low health literacy. The driving hypothesis of this research is that by providing clear and accurate information to older AAs will help address the underutilization of hospice by clarifying misperceptions, building trust, and overcoming literacy barriers. Patient decision aids (PtDAs) are an evidence-based approach to improve patient agency in medical decision making. Research shows that AA report a desire for more agency and autonomy in decision-making yet the use of PtDAs is understudied in AA communities. This proposal offers a unique opportunity to address many of the potential barriers that may prevent older AAs from enrolling in hospice, while simultaneously expanding the literature of SDM specific to older AAs. The goals of this proposal are to evaluate if the relationships between health literacy and hospice knowledge, attitudes, and beliefs is mediated by mistrust in healthcare and perceived discrimination among AAs aged 65 or older (Aim1) and to evaluate the effect of the hospice PtDA on changing hospice knowledge and attitudes and beliefs about hospice in AA aged 65 and older (Aim 2).


Eligibility Criteria:
Inclusion Criteria:

* Self identify as Black or African American
* At least 65 years of age

Exclusion Criteria:

* Non-English speakers.
* Patients with cognitive Impairments preventing ability to provide informed consent.
Natural Language Processing (NLP) Analysis of Free Text Notes to Investigate Coronavirus (COVID-19)

A retrospective cohort study investigating clinical notes using Natural Language Processing in combination with structured data from the Electronic Health Record (EHR) to create a database for analytics to identify features associated with outcomes.

Patients admitted to Cambridge University Hospitals (CUH)with COVID-19 have undergone routine clinical documentation and specific investigation and testing for COVID-19. The pathway for these patients ranges from supportive measures on the ward to deterioration requiring Intensive therapy Unit (ITU) admission and ventilatory support. Patients are also at risk of developing complications such as Acute Kidney Injury and thromboembolism. Identification of the risk factors for these and other outcomes such as the requirement for ventilation remain a challenge and reviewing the clinical data for these patients is critical in the understanding of the relationship between patient characteristics and outcomes.

There is data available in structured fields in the EHR, however, this is sometimes incomplete and inaccurate. An assessment of the free text clinical notes provides an opportunity to fill in the gaps and provide a much richer dataset for evaluation. We plan to use Natural Language Processing (NLP) (a field of machine learning that allows computers to analyse human language) to review Discharge Summaries of patients admitted to hospital with COVID-19 and convert free text data into structured data for analysis.

The NLP techniques developed by Dr Collier's team include methods for coding of free texts to SNOMED CT and other biomedical ontologies. These methods, based on statistical machine learning from human annotated texts, have been benchmarked for scientific texts and social media. In this project we intend to adapt these techniques for patient records. The techniques will require a number of human annotated patient records in order to adapt. The NLP output will be combined with structured data from the EHR and undergo statistical analysis to identify the rates of complications in patients with COVID-19 and risk factors associated with these. This may help to guide management decisions by earlier intervention to prevent poor outcomes in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Age range: 18 to 100 years
* Patients admitted to Cambridge University Hospitals with confirmed COVID-19 on lab testing

Exclusion Criteria:

Children and patients with a negative COVID test.
Comparison of Exercise Intervention Effects Following Lumbar Microdiscectomy

Low back pain is common, costly and affecting up to 80% of the population with the lumbar discectomy being a frequent spinal procedure for disc herniations. Pain \& mobility impairments persist in patients following microdiscectomy with long term issues of back pain. The question remains as to why some patients recover quickly and without lasting difficulties while other patients persist with prolonged disability following the same surgery. The purpose of this study is to determine how to guide the patient towards full function and evaluate the timing to initiate strengthening, neurodynamics and a walking exercise program.

The direction of treatment for low back pain both surgically and conservatively seeks to improve function in both daily and sporting activities for all patients. The patients continuing to suffer from a significant level of pain, disability and reduced function following single level microdiscectomy may benefit from a multi-factorial approach. A reduction in neurodynamic mobility related to dural adhesions is considered to be a contributing factor in this persistent peripheral neuropathic pain. The clinical efficacy of this study will address an exercise protocol post surgery in order to provide an optimal approach in the prevention of scar tissue that may be contributing to persistent pain post microdiscectomy. Mobility and motor control impairments are considered the consequence to the onset of pain. Education, neurodynamics and stabilization exercises are instrumental in the recovery post microdiscectomy with a reduction in pain and disability and the goal towards full functioning. The introduction of a neurodynamic protocol as an early exercise intervention may serve to reduce pain inhibition resulting with improved mobility and motor control. The recording of step count per day following a lumbar microdiscectomy will serve to document daily and physical activity levels following surgery. The purpose of this study is to determine whether or not there is a significant difference in pain levels and lumbar mobility between an early exercise intervention group versus a late exercise intervention group post microdiscectomy.

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated unilateral post-op microdiscectomy L3-4, L4-5, L5-S1
* Radicular symptoms within one year of surgical intervention
* Ability to understand English or French for instructional purposes
* Able to participate in physical activity

Exclusion Criteria:

* Under the age of 18 years or over the age of 65 years
* Diagnosis of inflammatory conditions such as rheumatoid arthritis, ankylosing spondylitis
* Neoplasm
* Metabolic bone disease
* Cauda equine syndrome
* Neurological disorders ie Multiple Sclerosis, Parkinsons
* Compression of the spinal cord
* Uncontrolled cardiovascular or respiratory disease
* Peripheral vascular disease with sensory loss in the foot
* Discitis
* Pregnancy
* Previous spinal surgeries
Assessment of the Sympathetic Nervous System Blockade of the Upper Limb After a Brachial Plexus Block in Patients With End Stage Renal Failure

The purpose of this study is to investigate what effect a local anesthetic nerve block of the arm in patients with end stage renal failure has upon blood flow in the skin of the arm.

Aim

To quantify the degree of sympathetic blockade in the upper limb in patients with end stage renal failure produced during a regional anaesthetic technique, using laser Doppler flowmetry.

Hypothesis

Regional anaesthesia of the upper limb results in blockade of motor and sensory nerves, providing surgical and post-operative analgesia. Sympathetic nerves are also blocked resulting in local vasodilatation. This may be of benefit in surgery where enhanced blood flow is beneficial such as arterio-venous fistula creation. The degree and duration of sympathetic blockade produced by regional blocks however, has never been quantified. This study aims to quantify sympathetic blockade by measuring the changes in skin blood flow and skin temperature after placement of a brachial plexus block.

Eligibility Criteria:
Inclusion Criteria:

* Patients with end stage renal failure
* Over 18 years of age
* Written consent obtained
* Due to undergo surgery for forearm fistula creation under a regional block

Exclusion Criteria:

* Smokers
* Damaged skin on the arm
* Circulatory disorders such as Raynaud's disease, systemic sclerosis, sickle cell trait or disease
* Current use of beta blockers
* undergoing haemodialysis for more than 12 months
Tomotherapy in Postsurgery Recurrent Carcinoma Cervix

Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix. However it is technically difficult to deliver adequate doses of RT due to presence of small intestines in the radiation area; thus disease control rates are poor and complication rates are high with conventional radiotherapy. Use of IMRT and brachytherapy for these cases allows for increasing dose to the tumor while sparing normal structures. It is expected that the use of a combination of IMRT \& brachytherapy will achieve higher disease control rates and decrease the complication rates.

SPECIFIC OBJECTIVES:

1. To evaluate the efficacy of combination of intensity-modulated radiotherapy (IMRT) and brachytherapy in delivering dose escalated radiotherapy in postoperative residual / recurrent cases of carcinoma cervix, in terms of local control proportion and progression free survival (PFS)
2. To study the late and acute toxicities associated with this treatment.
3. Dosimetric comparison of Tomotherapy and conventional IMRT

DESIGN: Prospective, phase II study.

STUDY POPULATION: All patients of age \< 65 years diagnosed with postsurgery recurrent squamous cell carcinoma cervix without previous history of radiotherapy.

STUDY SIZE: 90 patients

METHODOLOGY: Ninety cases of cervical cancer with postsurgery recurrence limited to the pelvis will be screened and taken for study if eligible after taking the informed consent.

Patients will receive external radiation therapy using IMRT to pelvis with additional dose of localized radiotherapy boost with brachytherapy to the vault with weekly concurrent chemotherapy.

The local recurrence rate and 5 year disease free survival rate of all the patients will be studied.

PROJECT PERIOD:

Total project period : 5 years Recruitment, Data collection : 4 years Complete analysis of data : 1 year

STUDY SITE: Tata memorial centre

Eligibility Criteria:
Inclusion Criteria:

. Only histologically proven postoperative recurrence of squamous carcinoma of cervix following hysterectomy \>3 months without adjuvant treatment

* Patients below 65 years of age and with KPS \>70%.
* Patients with disease confined to the pelvis, based on CT/MRI/PET Scan
* Normal ECG and cardiovascular system
* Normal hematological parameters
* Normal renal and liver function tests

Exclusion Criteria:

* Previous chemotherapy or radiotherapy to the pelvis
* Pelvic LN \>3cm in size
* Presence of disease outside the pelvis (Paraortic nodes, distant metastasis)
* Bilateral hydronephrosis
* Co-morbid conditions like uncontrolled Diabetes Mellitus or medical renal disease
* Medical or Psychological condition that would preclude treatment
* Patient unreliable for treatment and follow-up.
One Session Virtual Reality During Ongoing Treatment for Anxiety: Feasibility in Children and Adolescents

The goal of this study is to evaluate one session with exposure with Virtual Reality (VR) in in children and adolescents, aged 8-18 years with an anxiety disorder. The main questions it aims to answer are:

1. What are the expectations of children and adolescents and therapists with VR exposure?
2. What is the acceptability of the VR session (positive and negative effects)?
3. What are possible working mechanisms of VR exposure? During ongoing treatment, participants will receive a session of exposure with VR.

Cognitive behavioral therapy is an effective treatment for anxiety disorders, with exposure as the most important working ingredient. Exposure therapy can be challenging to implement in face-to-face settings. Virtual reality (VR) has emerged as a promising tool for delivering exposure therapy.

In the current study, the researchers will examine children and adolescents that will participate in a single session of VR exposure during their regular treatment (n=30). Willingness to participate in exposure in vivo will be assessed directly before and directly after the session. During the session anxiety, idiosyncratic expectations, and self-efficacy will be assessed. Expectations will be measured before the session and acceptability after the session.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents 8-18 years old.
* Meeting Diagnostic and Statistical Manual of Mental Disorders -5 criteria for an anxiety disorder, based on a semi-structured interview (SCID-5 Jr, specific section) or clinical judgment of an experienced and authorized clinician.

Exclusion Criteria:

* Severe psychiatric symptoms other than anxiety disorder interfering with safety or warranting immediate intervention, e.g. psychosis or acute suicidality.
Peripheral Artery Disease (PAD) : Its Effects on Bone

Prevalence of PAD and osteoporosis (OP) both get higher with age. Clinical and epidemiologic evidence have showed an increased cardiovascular risk in OP and bone loss and fragility fractures in patient with cardiovascular disease.

This study will examine the relationship between vascular disease in legs and sBMD and vBMD at trabecular and cortical sites and bone microarchitecture.

The primary goal of our study is to determinate if presence of PAD is associated with lower sBMD and vBMD values at the tibias, assuming that BMD should be more alterate in the predominant vascular impairement site.

Our secondary objectives are to :

* determine if severity of PAD quantified by ankle brachial index ABI is associated to a decrease of BMD values defined by T-Score at the left hip, spine and legs, but also with volumetric values, assessed by HRpQCT at the non dominant radius and at both tibias.
* determine the prevalence of osteoporosis in our population
* To evaluate the relationships between ;
* lipids and bone parameters
* vit D and parathormone with PAD severity
* levels of physical activity and both vascular and bone impairments

Eligibility Criteria:
Inclusion Criteria:

* PAD patients defined by an Ankle brachial index \< 0.9
* Written consent
* Patient affiliated with a social security organism

Exclusion Criteria:

* Age \< 18 years
* Pregnancy or risk of pregnancy
* Patients Under guardianship
* Patient with known PAD who had been previously treated by surgery or endovascular pathway
Selenium Supplementation of Patients With Cirrhosis

The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium.

Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The liver converts dietary selenium to a form that can be used to make selenoproteins. Patients with cirrhosis have much lower selenium levels than healthy individuals. We hypothesize that patients with cirrhosis are unable to utilize dietary selenium for selenoprotein synthesis. These patients may benefit from another form of selenium: selenate.

We will compare the effects of two supplemental forms of selenium on plasma selenium levels in patients with cirrhosis. Patients will be randomized to receive either a placebo, 200 µg selenomethionine, 200 µg selenate or 400 µg selenate, daily, for 8 weeks. We will measure selenium levels in the blood at baseline, week 4 and week 8. We will determine which forms of selenium, if any, increased plasma selenium levels of the cirrhosis patients.

Eligibility Criteria:
Inclusion Criteria:

* liver disease
* aged 18 or above

Exclusion Criteria:

* substance abuse
* renal failure
A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)

The goal of the study is to learn what happens to levels of MK-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time. Researchers will compare what happens to MK-5684 after hemodialysis in people with severe renal impairment and end-stage renal disease versus healthy people.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include, but are not limited to:

All Participants

* Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to the first dosing
* Has a body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m\^2 at the screening visit

Participants with severe renal impairment (RI) (Group 1):

* Has severely impaired renal function as determined by estimated glomerular filtration rate (eGFR) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation

Participants with end-stage renal disease (ESRD) (Group 2):

* Has ESRD maintained on stable outpatient regimen of intermittent high-flux hemodialysis (HD) (at least 3 times per week) for a minimum of 3 hours per dialysis session, using a complication free well-maintained arteriovenous fistula or arteriovenous graft, for at least 3 months prior to first dosing and is expected and planning to continue HD during the study and at least up to the follow-up visit

Healthy Control Participants (Group 3):

* Has normal renal function

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

All Participants:

* Has a history or presence of any of the following: Adrenal insufficiency; Hepatic impairment; Clinically significant hypotension; cardiac arrhythmia; cardiac conduction abnormalities or recurrent unexplained syncopal events; Second- or third-degree atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker); Clinically significant sick sinus syndrome; Any systemic fungal infection; Hypothyroidism; Chronic infection
* Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
* Has a history of cancer (malignancy)
* Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Participants with Severe RI (Group 1):

* Has a history or presence of renal artery stenosis
* Has had a renal transplant
* Has ESRD requiring HD

Participants with ESRD (Group 2):

* Has required frequent emergent HD (≥ 3) within a year prior to the first dosing
* Has a history or presence of renal artery stenosis.
* Has had a functioning renal transplant within the past 2 years
FAZA PET/MRI in CLI Patients Pre and Post Revascularization

Peripheral artery disease is a worldwide problem, leading to high mortality and mobility.

Critical limb ischemia (CLI) is associated with high risk of amputation with the subsequent decreased in life quality. Endovascular therapy is now considered the primary treatment option in these patients to improve the vascularity and prevent amputations.

In recent years, development of molecular imaging tools are now become available. A recent radio tracer named 18F-Fluoroazomycin Arabinoside (FAZA) its an specific marker of hypoxia in the tissues and has been used in multiples studies. This tracer can be used in PET/MR scan providing a potentially power diagnostic tool in patients with CLI, allowing in one diagnostic study the evaluation of location and degree of hypoxia in the extremity tissues. This diagnostic tool may offer a better assessment pre and post standard of care endovascular treatment for the patients.

Moreover, some of the patients treated with endovascular therapy may not have a favorable outcome, without a clear reason explaining this situation. We will try to find some predictor model in the FAZA PET/MR that can explain the different outcomes and may help clinicians choose the best treatment option in specific cases.

Thirdly, post processing for optimization of the MR sequences in patients with CLI will be performed at the MR component of the PET. There would thus be great clinical interest in developing non-invasive tools that could provide more accurate diagnostic information compared to traditional tests for these patients population.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years;
* Patients with clinical evidence of critical limb ischemia that are candidates for revascularization treatment;
* A negative urine or serum pregnancy test in women of child-bearing age;
* Ability to provide written informed consent to participate in the study.

Exclusion Criteria:

* Contraindication for MR as per current institutional guidelines;
* Inability to lie supine for at least 30 minutes;
* Pregnant or breastfeeding;
* Unable or unwilling to provide informed consent;
* Impending amputation within 6 weeks of presentation;
* Previous metallic hardware in the lower limbs;
* Unable to have ethanol.