cyrilzakka/clinical-trials huggingface dataset:
Bedside Ultrasound Assessment of Feeding Tube Position in the Intensive Care Unit

This diagnostic accuracy study aims to evaluate the performance of bedside ultrasound compared to x-ray in detecting the correct position of feeding tubes among critically ill adult patients. The main questions it aims to answer are: • diagnostic accuracy of bedside ultrasound • feasibility of its wide adoption among practitioners with minimal training in busy intensive care units.

This multicenter diagnostic accuracy study consists of a non-consecutive convenience sample of adult patients admitted to the intensive care unit starting from March 2023 who require a feeding tube as defined by the medical attending team.

Right after feeding tube placement following the institutional standard operating procedure, attending physicians perform bedside ultrasound assessment to verify the correct position of the tube. They report whether or not visualizing the feeding tube in four steps: 1) in the esophagus from either the right or left side of the patient's neck; 2) in the transverse view of the patient's epigastrium; 3) in the longitudinal view of the patient's epigastrium and 4) during the injection of 20 mL of air into the tube to detect the 'fogging sign.' Finally, the abdominal radiograph (gold standard) confirms the gastric or duodenal placement of the feeding tube.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old;
* Need for a tube feeding for receiving diet and/or medication, as indicated by the medical team;
* Blind insertion of a tube feeding in the intensive care unit, following the standard operating procedure;
* Presence of a trained physician for ultrasound scanning of the tube feeding immediately after installation.

Exclusion Criteria:

* Major abdominal postoperative wounds, peritoneostomy, or any other conditions that preclude ultrasound abdominal examination;
* Exclusive presence of a gastric decompression probe, which does not require radiographic confirmation;
* Tube feeding introduced under digestive endoscopy guidance;
* Gestation;
* Abdominal radiography confirming the tube position obtained before the ultrasound assessment.
Acceptability and Feasibility of Apollo in Veterans With a History of PTSD

The proposed investigation is an open label pilot study intended to establish the acceptability and feasibility of the Apollo in a population of Veterans. Exploratory data regarding biological signatures will also be collected.

Evaluation of Apollo requires a stepwise process in which initial aims are geared towards identifying biological signatures versus diagnosing, treating, mitigating or curing any conditions. Towards the end of identifying potential biological signatures, we hypothesize the following. 1) Participants who use the Apollo will have an attenuated physiological stress response as measured by improved heart rate variability (HRV) compared to baseline. 2) Participants who use Apollo will have attenuated perceived psychological stress measured by lower scores on psychological correlates of acute stress when compared to baseline

Eligibility Criteria:
Inclusion Criteria:

1. Veterans eligible to receive care by a VA provider
2. History of at least one deployment in support of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND)
3. Current diagnosis of PTSD per the Clinician Administered PTSD Scale-5 (CAPS-5)
4. Willingness to wear the Apollo daily and to comply with study protocol
5. Android or Apple smart phone on which the participant can download the Apollo mobile app
6. Age between 18 and 65
7. Ability to provide informed consent

Exclusion Criteria:

1. Inability to adequately respond to questions regarding the informed consent procedure
2. Currently involved in the criminal justice system as a prisoner or ward of the state
3. Current (past month) alcohol or substance abuse or dependence
4. Lifetime history of bipolar disorder, psychosis, or delusional disorders
5. Lifetime history of oppositional defiant disorder or anti-social personality disorder
6. Pregnancy
7. Recent medication changes in the past 4 weeks
8. A current beta blocker prescription (other than prazosin)
9. Active untreated visual impairment
Aging and Gastrointestinal Barrier Function

The purpose of this study is to assess the gastrointestinal responses of the elderly and younger populations during hyperthermia.

Heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. Although gastrointestinal barrier dysfunction is a primary cause of heat related illness, little is known about the effects of aging on gastrointestinal barrier function during hyperthermia. The central hypothesis of this work is that the elderly exhibit greater gastrointestinal barrier dysfunction during hyperthermia. Participants will complete a control trial where gastrointestinal permeability (without heating) will be assessed in young and older adults. In the experimental trial, controlled hyperthermia will be achieved using a water perfused, tube lined suit. Core body temperature will be raised to a maximum of 2 degrees Celsius above the baseline value, or an absolute temperature of 39.5 degrees Celsius. Core temperature will not be collected during the control trial. Comprehensive assessments of gastrointestinal barrier function and systemic inflammation will be assessed in young and older adults. The expected outcome of this work will re-shape our understanding of the consequences of aging on gastrointestinal barrier function during heat waves.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female individuals
* 18-35 years or 65+ years of age
* Free of any underlying moderate to serious medical conditions

Exclusion Criteria:

* Known heart disease
* Any chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, inflammatory bowel disease, and uncontrolled hypercholestrolmia etc;
* Abnormality detected on routine screening suggestive of provocable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Subject with a body mass index ≥35 kg/m2
* Pregnant
* Use of immunosuppressant drugs within last 4 weeks prior to screening
* Use of antibiotics or antimicrobial medication in last month
* Any previous abdominal surgery
* Use of steroids in last 6 weeks
* Regular use of probiotics in last month
* Use of laxatives or anti-diarrhetic in last month
EpiCeram for Skin Protection in Healthcare Workers

This is an open-label study using a device currently prescribed by doctors. This means everyone involved in the study will know the name of the product, only one product will be used, and the U.S. Food and Drug Administration (FDA) has approved the sale of this product. Although this is called a device, the product is an emollient-type lotion.

Healthcare workers (HCW) often suffer from signs and symptoms of skin irritation, including pain, redness, roughness, dryness, cracking and itching due to the extensive use of personal protective equipment (PPE) such as masks and gloves. These are thought to be due to changes in the normal skin barrier function induced by repeated minor abrasion in the warm, moist environment induced by extensive use of PPE required at work. EpiCeram Controlled Skin Barrier Emulsion (EpiCeram) is a prescription skin barrier repair product containing ingredients designed to improve skin barrier function. However, EpiCeram has not previously been studied in people with skin irritation due to extensive use of PPE.

This study was terminated after 1 (one) subject was enrolled due to the inability to find willing participants.

At the screening visit, the study will be explained, and the participant will have the opportunity to ask questions. If the participant decides to enroll, they will have to read, sign and date this Informed Consent Document. The study staff will take the participants pertinent medical history to evaluate eligibility. The participant will be asked about the kind of skin products they are using as well as about use of PPE. Visit 2 activities may be performed at the Screening visit.

Participants will return to the study site one (1) week later and 28-days later to have Photographs, Skin Function Testing, and Laboratory Testing performed. The participant will be asked to avoid applying any skin products (except make-up) to the skin for the following week and for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

1. HCW using PPE at least 6 hours/day, 4 days/week or, depending on shift work, 24 hours/week, for at least one (1) month
2. Men or women, any age
3. Overall skin irritation score of at least 4 on 0-10 scale where 0 = none and 10 = worst
4. Willing to stop use of any other emollient and lotion for one (1) week between screening and baseline visit and for the duration of the study.
5. Participant is willing to stop use of or not begin use of any topical corticosteroids, emollients and lotions to the hands and face for the duration of the trial.

Exclusion Criteria:

1. History of any skin disorder existing prior to March 1, 2020 characterized by chronic visible lesions or skin irritation symptoms including, but not limited to atopic dermatitis, eczema, moderate-severe acne, chronic dry skin and psoriasis.
2. Use of topical corticosteroids within one (1) month of baseline visit.
3. History of any significant medical condition that, in the opinion of the investigator, might put the subject at risk in this trial.
4. Participation in another clinical trial within 30 days or 5 half-lives of the study agent, whichever is longer.
Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.

Computed tomographic pulmonary angiography (CTPA) is considered the gold standard for the diagnosis of pulmonary embolism (PE). PE is a potentially fatal disease in which a thrombus is lodged into a pulmonary artery blocking blood flow and potentially leading to respiratory distress, acute right cardiac failure or death. Therefore early and correct diagnosis is crucial.

The diagnostic and clinical value of CTPA has already been firmly substantiated. Unfortunately up to 7.3% of PE scans are still deemed to be non-diagnostic, for example due to insufficient contrast enhancement in the target arteries.

Therefore future research should focus on two important aspects of CT imaging. On the one hand optimal enhancement for the individual patient, on the other hand preventing additional risk of CT imaging - namely contrast induced nephropathy (CIN) and radiation risk. Thus the purpose of our study will be to optimize radiation dose settings (e.g. tube voltage, tube current) and CM application for the individual patient in CTPA.


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of pulmonary embolism

Exclusion Criteria:

* Severe allergy against Iopromide or any of the ingredients, previous severe CM reaction (according to current ESUR guidelines), renal insufficiency, pregnancy
Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark

This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate assessment of prescriptions and diagnoses, especially those related to cancer patients during the first year post the initial market availability of XGEVA.


Eligibility Criteria:
Inclusion Criteria:

The study will include patients with a prescription for XGEVA® given in secondary care with a minimum of 108 XGEVA users, in the Northern Jutland Region and Copenhagen during the first 1-year post XGEVA market availability, defined as 12 months after RADS opinion on 24th January 2013 or after the minimum sample has been achieved.

Exclusion Criteria:

n/a
SMILE vs. LASIK Using Contoura With Phorcides

Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.

Once consented to participate in the study, subjects will have a comprehensive ocular examination to determine eligibility to undergo simultaneous SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.The study objective is to compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, high order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using Contoura with Phorcides and SMILE surgery. Surgical treatment will be randomized so there is a 50% chance to receive SMILE on the right eye and LASIK on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. Visual outcomes and patient self-reported symptoms will be assessed at week 2, month 1, month 3, and month 6.

Eligibility Criteria:
Inclusion Criteria:

* Male and Females between the ages of 21 and 50
* Nearsightedness between -2.00 diopters and -8.00 diopters
* Have similar levels of nearsightedness in each eye (≤1.5D of difference between eyes)
* Less than or equal to 3.00 diopters of astigmatism
* Have similar levels of astigmatism in each eye (≤0.75D of difference between eyes)
* Total spherical equivalent (SE) of no more than -8.0 D
* Tricare Prime Beneficiary
* Residing within 60 miles radius from Lackland AFB

Exclusion Criteria:

* Subjects with corneal abnormal findings including signs of keratoconus, keratoconus suspect, abnormal corneal topography, epithelial basement membrane disease, pellucid marginal degeneration, corneal degenerations, progressive and unstable myopia, irregular or unstable corneal mires on central keratometry images, and patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma from the corneal endothelium.
* Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases
* Pregnant or nursing females
* Systemic disease likely to affect wound healing, such as uncontrolled diabetes and severe atopy
* Any ocular disease such as advanced/uncontrolled glaucoma, severe dry eye, active eye infection or inflammation, recent herpes eye infection or problems resulting from past infection.
* 0.25 or 0.50 of manifest astigmatism in either eye
* Taking the medication Isotretinoin (Accutane) or antimetabolites for any medical condition.
Long Term Cardiovascular Disease Event Risk for Patients Undergoing Major Non-Cardiac Surgery

The goal of this observational study is to learn whether the healthy lifestyle choices made around surgery can influence an individual's long term risk of developing cardiovascular disease. Patients will be observed 1-month prior to and 3-months following surgery to assess their risk of developing cardiovascular disease.

Patients who experience a medical event are often motivated to improve their health by engaging in healthy lifestyle behaviors, such as improving their diet and beginning to exercise. For example, patients who are considered smokers prior to surgery may sometimes stop smoking following surgery. However, we are unsure of other changes following surgery. For example, we are unsure if surgery can initiate any changes in exercise and diet, and we are unsure if these changes can influence the risk of developing cardiovascular disease. Consistent and positive lifestyle changes will likely reduce an individual's risk of developing cardiovascular disease in the long term.

Eligibility Criteria:
Inclusion Criteria:

* Age 45 - 75 years
* Scheduled for intermediate- to high risk non-cardiac surgery (intra-thoracic or intra-abdominal surgery, all vascular surgery, intra-cranial neurosurgery, spine surgery)
* Expected post-operative length of stay of at least two days, according to the surgeon's expectation
* At least two of the following CVD risk factors:

History of: Hypertension, Diabetes, Coronary artery disease, Chronic heart failure, Chronic kidney disease, Cerebrovascular disease, Peripheral vascular disease.

Obesity (BMI \>25 kg/m2), Current smoking, Poor exercise capacity (\<4 METS)

Exclusion Criteria:

* Currently participating in a CVD risk reduction program
* Patient is scheduled to undergo transplant or has undergone emergency surgery
* Life expectancy \<1 year (palliative surgery)
* Recent (\<6 months) myocardial infarction or stroke
* Surgery scheduled \<1 month
* Inability to effectively communicate
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)

The Investigators will test the hypothesis that 2-HOBA will reduce modification of HDL and LDL and improve HDL function in humans with heterozygous FH. The Investigators plan to first study subjects with Familial Hypercholesterolemia (FH), treating them with 750 mg of 2-HOBA or placebo every 8 hours for 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with heterozygous Familial Hypercholesterolemia.

Exclusion Criteria:

* Myocardial infarction or stroke within the last 6 months
* unstable angina, symptoms of angina within the last 3 months
* NYHA class III or IV heart failure or LVEF \< 30%
* poorly controlled hypertension: SBP \> 180 mm Hg or DBP \> 110 mm Hg,
* pregnancy,
* evidence of a previous acute coronary syndrome,
* current smokers,
* individuals with Type 2 Diabetes Mellitus, obesity (BMI \> 30),
* hypertriglyceridemia (fasting TG \> 250 mg/dl),
* renal insufficiency (Cr \> 1.8),
* hepatic disease (aspartate aminotransferase(AST) or alanine aminotransferase (ALT) \> 2x ULN),
* hypothyroidism,
* nephrotic syndrome,
* rheumatoid arthritis,
* systemic lupus erythematosus,
* AIDS or HIV
* history of malignancy of any organ in last 5 years.
Waiting Room's Environment and Children Anxiety Prior Dental Treatment

The amount of time the patient has spent awaiting treatment and the nature of the waiting room environment influence the anxiety level prior treatment. The objective of the present study is to compare the effect of waiting room's environment on the levels of anxiety experienced by children, in sensory adapted dental environment (SADE) and traditional waiting rooms. A parallel randomized trial. The participants will be randomly assigned to one type of waiting room. The participants will be asked to answer Venham Picture Test (VPT) scale while waiting in the waiting room just before entering the clinic.

The SADE waiting room: a small waiting room (2.5mx2.5m) inside the clinic with 6 seats. All ceiling fluorescent lighting is removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, and a lighting column that children can touch and climb on. Auditory stimuli include rhythmic music, which is heard via loudspeakers. The traditional waiting room: a waiting area outside the clinic with ten seats in one row faces the reception desk in an area of 15 square meters. The area is air-conditioned, moderately well-lit, without posters or paintings on the walls, and no reading material.

•Dental anxiety scale- Venham Picture Test (VPT) is widely used and easily administered. In this test, children are presented with eight cards, with two figures on each card, one 'anxious' figure and one 'nonanxious' figure. They are asked to choose the figure from each pair that describes how they feel at that particular time. All cards are shown in their numbered order. If an anxious figure is chosen, a score of one is recorded. If a nonanxious cartoon is chosen, a score of zero is recorded. A measure of anxiety is obtained by totaling the number of times the child picks the cartoons depicting the anxious state (minimum score, 0; maximum score, 8). The participants will be asked to answer while waiting in the waiting room just before entering the clinic.

Study design- The study is a parallel randomized trial. The participants will be randomly assigned to one type of waiting room.

Additional data- gender, age, the lengths of waiting, the purpose of the visit (examination or treatment with/without sedation), dental experience, type of waiting room, child escort.

Eligibility Criteria:
Inclusion criteria: healthy 3-10 years old boys and girls Exclusion criteria: mentally unable to understand and answer the Venham Picture Test (VPT) to assess anxiety before treatment, accepted immediately without waiting.
Effect of Laser Treatment for Diabetic Retinopathy on the Optic Disc Topography

This study analyzed diabetic patients without evidence of glaucoma who underwent panretinal photocoagulation to determine the effect on optic disc topographic parameters in non-glaucomatous patients with proliferative diabetic retinopathy (PDR).

Glaucoma and proliferative diabetic retinopathy (PDR) are two very prevalent diseases that often coexist. Previous literature suggest that panretinal photocoagulation may somehow lead to optic disk cupping. Therefore, evaluation of the optic disc cupping and of possible glaucomatous damage in patients with diabetic retinopathy can be difficult, especially after PRP treatment. The purpose of this study is to determine the long-term effect of PRP on optic disc topographic parameters in non-glaucomatous patients with PDR using Heidelberg retina tomograph (HRT) parameters and stereo photography. The Investigators found that PRP does not cause morphological optic disk changes in diabetic PDR patients after one year of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PDR (due to type 1 or 2 diabetes mellitus)
* intraocular pressure \< 18 mmHg
* nonglaucomatous optic disc characteristics at fundus examination
* vertical cup-to-disc (C/D) ratio \<0.7
* absence of media opacities

Exclusion Criteria:

* previous diagnosis of glaucoma
* family history of glaucoma
* neuroophthalmic disease
* uveitis
* retinal artery or vein occlusion
* optic disc neovascularization
* diabetic macular edema (DME)
* corneal opacity
* previous laser photocoagulation treatment