cyrilzakka/clinical-trials huggingface dataset:
Using Health Information Technology (HIT) to Improve Transitions of Complex Elderly Patients From Skilled Nursing Facility (SNF) to Home

The incidence of drug-induced injury is high in the ambulatory geriatric population, especially for elders with complex healthcare needs during high risk transitions to the ambulatory setting. In a previous study funded by the National Institute on Aging and the Agency for Healthcare Research and Quality \[AHRQ\] (AG 15979), the investigators determined that drug-related injuries occur at a rate of more than 50 per 1000-patient years in older adults in the ambulatory setting and that 28% are preventable. Independent risk factors for adverse drug events among older adults in the ambulatory setting included advanced age, multiple comorbid conditions, and the use of medications requiring close monitoring. In this project, Using HIT to Improve Transitions of Complex Elderly Patients from SNF to Home (1 R18 HS017817), the investigators are testing the use of an electronic medical record (EMR)-based transitional care intervention for complex elderly patients transitioning from subacute care in a skilled nursing facility (SNF) to the ambulatory setting. The growing trend for physicians and other healthcare providers to restrict their practices to single settings and not follow complex patients as they move between settings leaves older patients discharged from subacute care particularly vulnerable. This transition is uniquely challenging because of the complex healthcare needs of this population, who often require outpatient primary care physicians to coordinate with visiting nurses in order to manage complex medication regimens and fluctuating clinical status. To facilitate high-quality transitions from the subacute to the ambulatory setting and support interdisciplinary communication, the investigators will use the EMR to assure that physicians in the ambulatory setting receive key health information and alerts.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and older,
* Member of the study site health plan,
* Received care from one of the study site's geriatricians during a SNF stay,
* Discharged from SNF to home.

Exclusion Criteria:

* Does not meet inclusion criteria.
Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19

The SWITCH-COVID trial will randomize patients with COVID-19 that are currently using renin-angiotensin system inhibitors for treating hypertension to maintain the therapy during in-hospital stay or switch the therapy to other antihypertensive classes.

Patients eligible for the study, after signing informed consent will be randomized 1:1 for maintenance of renin-angiotensin system inhibitors or switching the antihypertensive therapy for other classes according to a pre-specified protocol.

Patients are going to be followed during hospital stay for evaluation of clinical endpoints. Also blood and urine samples will be acquired for evaluation of renin-angiotensin system activation.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension in use of renin-angiotensin system inhibitors
* Confirmed COVID-19 infection by rt-PCR, serology tests or typical clinical presentation and chest CT.
* Symptoms onset \< 96h
* Need for hospitalization

Exclusion Criteria:

* Heart failure
* Previous cerebrovascular disease
* Previous myocardial infarction
* Blood pressure \> 180 x 100 mmHg
* Need for 3 or more anti-hypertensive classes
* Use os spironolactone
* Severe pulmonary disease
* Contraindication for using other anti-hypertensive classes (calcium channel blockers, hydralazine, diuretics or nitrates)
Prevalence And Burden Of Nausea And Vomiting In Pregnant Women

On February 25th, 2019, ITALFARMACO launched Nuperal® in Italy, an association of doxylamine succinate and pyridoxine hydrochloride authorized by AIFA for the symptomatic treatment of nausea and vomiting in pregnancy (NVP). This drug is also recommended as first choice drug therapy by the American College of Obstetricians and Gynecologists (ACOG) Guidelines and is supported by extensive international literature.

Numerous epidemiological researches conducted in the US and Norway have highlighted the extent of vomiting and pregnant nausea. Unfortunately to date, there are no information on the prevalence of this phenomenon in Italy, on its impact on women's lives and on the interaction between woman and gynecologists.

The research hypothesis of the present survey is that, using a representative sample of pregnant women in Italy, it will be possible to identify the prevalence and weight of nausea and vomiting symptoms during pregnancy in this country. The study is an open, non-comparative, multicenter survey and the aim is to evaluate the prevalence and weight that the symptoms of nausea and vomiting have in pregnant women in Italy.

The study population will include 600 women found during weeks 18-22 of pregnancy who will arrive at the three sites or will contact the Investigators after the Ethics Committee (EC) approval.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian women in physiological pregnancy and between the 18th and 22nd week (time of morphological ultrasound).
* Women able to communicate adequately with the interviewer and understand the questionnaires.
* Women able to understand and who can provide valid informed consent to the Survey.

Exclusion Criteria:

* Twin pregnancy.
* Medically assisted procreation (MAP)
Melatonin and Sleep in Preventing Delirium in the Hospital

Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are given the supplement. This pilot study involves a randomized placebo-controlled design in which participants will be randomized to receive either melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep questionnaire each morning to obtain subjective data on their sleep quality overnight. Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method (CAM).


Eligibility Criteria:
Inclusion Criteria:

* 65-100 years old
* Admitted to Scripps Green Hospital
* Admitted to an Internal Medicine or Medicine Consult Service
* Expected to have a hospital stay of greater than or equal to 48 hours (patients admitted to "inpatient," not "observation," under Medicare guidelines)

Exclusion Criteria:

* Cirrhosis of any etiology
* Admitted for alcohol withdrawal
* Currently taking a 1st or 2nd generation anti-psychotic
* Active delirium (i.e., delirium prior to 1st dose of melatonin)
* Diagnosis of encephalitis
* History of seizure
MRI in Renal Transplantation

Renal transplantation is the optimal method of treatment for end stage kidney disease however median lifespan of a kidney transplant is around 15 years. Existing methods of measuring transplant function and structure from blood and urine markers are imperfect; renal biopsy is often performed but is invasive. Novel methods of investigating transplant function are therefore required and emerging renal MRI sequences including ASL and diffusion weighted imaging may yield helpful biomarkers. Investigators will recruit 20 patients in the first year after transplant and measure MRI biomarkers at three time points, with correlation to existing methods of measuring transplant function.

Kidney transplantation remains the optimal therapy for patients with end stage kidney disease and is associated with significant improvements in life expectancy and quality of life compared to subjects receiving dialysis. Despite significant advances in our understanding of the immune system and development of drugs to prolong transplant function, a large number (Scottish Renal Registry data suggest between 23-35%) of transplants fail in the 10 years from operation. This may be due to a number of factors but is often due to development of transplant rejection, where the recipient's immune system damages the transplant. Early recognition and implementation of therapy is needed to dampen this response, reduce irreversible damage and preserve transplant function.

At present, transplant function and damage is measured using blood and urine tests. These are far from perfect markers because there is a delay between transplant damage and abnormalities of these tests. This time is vital for the short and long term survival of the transplant.

In the University of Glasgow, investigators have developed a new type of magnetic resonance imaging (MRI) which allows assessment of kidney blood flow and fibrosis (scarring) without the need for administration of harmful contrast agents. Arterial spin labelling magnetic resonance imaging (ASL MRI) is a non-invasive method of measuring renal perfusion using magnetised blood as endogenous contrast and investigators have validated this technique previously in both individuals with and without kidney disease. Diffusion tensor imaging (DTI) is another modality of non-contrast MRI which allows measurement of 'stiffness' of renal transplants, which represents long term scarring and fibrosis.

The investigators intend to follow up people receiving a kidney transplant for one year, collecting samples of blood, urine, and performing MR imaging at 3 time points, in order to investigate novel biomarkers of transplant function and dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Recent or pending kidney transplantation
* Written informed consent

Exclusion Criteria:

* Severe chronic liver, heart or lung disease
* Chronic infection
* Unable to give valid informed consent
* Known pregnancy or intent to conceive during the study period
* Any contraindicating to MRI
Effects of Early Vestibular Rehabilitation in Patients With Dizziness and Balance Disorders After Sport Concussion

This study examines the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to achieve medical clearance to return to activities such as sports and work activities. Half of the participants will receive early vestibular rehabilitation added to standard of care, while the other half will receive standard of care only.

As awareness of concussion and the numbers of reported concussions increase every year in the last few years, so does the need for more effective treatment strategies. Concussions can lead to a variety of symptoms that may last from days to weeks after injury.\[1\] Dizziness and vestibular impairments are prevalent in up to 81% of patients after concussion.\[2,3\] Additionally, dizziness and vestibular impairments are predictive of prolonged recovery times after concussion.\[4\] Although there are few studies suggesting that vestibular rehabilitation after concussion is promising,\[5,6\] there continues to be a void in well-controlled studies verifying that vestibular rehabilitation can be used to treat patients with dizziness and balance disorders after concussion. Due to the lack of controlled studies and current practice patterns, patients with concussions are not seen for physical therapy until weeks or months after their injury. The purpose of this study is to examine the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems), and improving the timeline to achieve medical clearance to return to activities such as sports and work activities, when compared to STANDARD care. The findings of this study are expected to provide medical and sports related professionals with appropriate concussion treatment strategies and improve outcomes of patients suffering from concussion.

Eligibility Criteria:
Inclusion Criteria:

* Dizziness or balance problems within 10 days of concussion

Exclusion Criteria:

* None
Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin

This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face. The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face.


Eligibility Criteria:
Inclusion Criteria

1. Male and female patients aged 30 to 65 years.
2. Female patients must be of either:

   * Non-childbearing potential, provided there is a laboratory confirmed serum follicle stimulating hormone (FSH) level ≥ 40mIU/ml or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus); or
   * Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy.
3. Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures, including any alteration of medications in preparation for study entry.
4. Patient has agreed to allow photographs of the selected treatment area to be taken and used as part of the study data package.

Exclusion Criteria

1. Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate) Gel.
2. Current enrolment or participation in a clinical research study within 30 days of entry into this study.
Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.

Trainees' experience in cleft surgery is limited due to the high-risk nature of the surgery and centralization of cleft care. Simulations allow trainees to learn complex surgical skills whilst ensuring patient safety. Existing cleft surgical simulators are over-simplified or prohibitively expensive. We developed and tested a high-fidelity yet cost-effective simulator for cleft palate repair.

Skeletal elements were obtained through high-resolution scanning of a pathologic specimen, 3D printed and then molded in plastic. Soft tissue components were formed through molding layers of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.

Background: Trainees' experience in cleft surgery is limited due to the high-risk nature of the surgery and centralization of cleft care. Simulations allow trainees to learn complex surgical skills whilst ensuring patient safety. Existing cleft surgical simulators are over-simplified or prohibitively expensive. We developed and tested a high-fidelity yet cost-effective simulator for cleft palate repair.

Methods: Skeletal elements were obtained through high-resolution scanning of a pathologic specimen, 3D printed and then molded in plastic. Soft tissue components were formed through molding layers of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Plastic Surgery Training Residents

Exclusion Criteria:

-
Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

The purpose of this study is to examine whether buprenorphine can be at least as effective as other opioid medications in relieving chronic pain in patients who suffer from dependence on their opioid medications, while patients simultaneously experience progressive decline of pain along with absence of opioid withdrawal symptoms and improved quality of life.

The study will utilize sublingual buprenorphine for the treatment of chronic pain patients with co-occurring opioid dependence. Adult male and female chronic pain patients with co-occurring opioid dependence/disorder, being treated at MMC will be enrolled in a home induction procedure. Subjects will be switched from their current opioid pain medication to buprenorphine/naloxone to assess whether buprenorphine is at least as effective, if not more effective, as other opioid medications in controlling their pain while simultaneously improving their psychological distress, functional status, and other aspects of patients' lives. We will utilize a home induction procedure, and maintain subjects on this oral medication for a duration of 6 months. During this period

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM criteria for opioid dependence (or opioid use disorder when DSM 5 is in use)
* Has received opioid therapy for at least 90 days
* Has opioid dependence as assessed by a Maimonides psychiatrist

Exclusion Criteria:

* Scheduled for major surgery during study duration
* Predicted life expectancy \< 1 year
* Plan to cease habitation in greater New York area within 6 months
* Risks for buprenorphine outweigh potential benefit, as determined by the PI
* Lacks sufficient fluency in English to understand the study protocol, answer survey questions or give informed consent
* Pregnant women
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.


Eligibility Criteria:
Inclusion Criteria: - Type 2 diabetes - Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s) Exclusion Criteria: - An acute coronary or cerebrovascular event in the previous 60 days - Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure NYHA (New York Heart Association) class IV - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
Early Warning Systems, Risk of Early Clinical Deterioration

Primary purpose of the study was to evaluate the relationship between "NEWS" and "VIEWS" scores of patients who were screened retrospectively, early clinical deterioration, return to intensive care and morbidity / mortality.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* patients who were taken back to the intensive care unit in the first 24 hours

Exclusion Criteria:

* under 18 years old,
* patients undergoing postoperative intensive care,
* pregnant women
Confocal Endomicroscopy for Biliary Strictures -Phase I

The investigators hypothesize that the confocal endomicroscopy imaging of the biliary strictures during ERCP will differentiate between benign and malignant strictures in vivo and has increased sensitivity compared to biliary brushing/biopsy, and that direct cholangioscopic guidance of pCLE is more accurate than fluoroscopic guidance.

Despite recent advances in biliary imaging and biliary tissue acquisition, the diagnosis and tissue-confirmation in suspected malignant biliary obstruction remains challenging. Patients often undergo repeat endoscopic and cross sectional imaging procedures, and even surgical exploration to establish a diagnosis. A major new advancement in cancer imaging is the development of a probe-based confocal endomicroscopy (pCLE) system capable of cellular and sub-cellular imaging of the biliary tree. Preliminary data suggests that pCLE can accurately detect or exclude malignancy within otherwise indeterminate strictures. In this study, we propose to validate these preliminary findings and compare two methods of pCLE image acquisition that are important for clinical translation of the technology.

This is a Phase 1 Study: During this study, in vivo microscopic images of 10 benign (post-operative from know benign disease such as orthotopic liver transplant) and 10 malignant (cytology-positive) strictures will be obtained at ERCP. Patients clinical course will be followed and a composite gold standard will be used for comparison to pCLE. These confocal images of biliary lesions will be reviewed side by side, unblinded to the reference standard by the endoscopists. The basic image characteristics allowing distinction between benign and malignant tissue will be established (details of features noted and examined are below). We will also assess whether good quality images can be feasibly obtained without the cholangioscopic guidance.

Eligibility Criteria:
Inclusion Criteria:

* Pre-ERCP: Age above 18; imaging consistent with stenosis/mass of the hilum/extra-hepatic bile duct with abnormal liver chemistry, or painless jaundice referred for ERCP.
* Evidence of biliary obstruction as defined by elevated direct bilirubin (\> 1.5ULN) and dilation of the common or hepatic ducts \> 8mm) on imaging studies.

Exclusion Criteria:

* Unwilling/unable to consent.
* Definite pancreatic mass on CT/MR.
* Allergy to Fluorescein.
* Pregnancy (patient who could be pregnant will undergo pregnancy testing as per routine care)
* Indwelling metal biliary stent.