cyrilzakka/clinical-trials huggingface dataset:
Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

Background

Major spinal surgery tend to be lengthy with an increased risk of hypothermia. A quality improvement project of patients undergoing major spinal surgery showed that 67 % were hypothermic at the beginning of surgery. Several patients expressed a feeling of coldness at the arrival of the operating theatre.

Aim

To evaluate if Bairhuggers Full Access Underbody blanket can prevent hypothermia at initiation if used as prewarming and intraoperative warming compared to the results from the local quality improvement project. In addition we aim to explore patients´ experiences of comfort in relation to their temperature.

Method

Temperature of patients undergoing major spinal surgery (n=30) will be assessed at arrival to the theatre, after insertion of bladder catheter, at the start and end of surgery using a bladder temperature. The patients´ experiences of comfort will be evaluated with a 5 point Likert at the arrival to the operating theatre and after ten minutes of active prewarming with Bairhuggers Full Access Underbody blanket. Preoperatively ten randomly chosen patients will be observed and later interviewed in order to obtain further information regarding their experiences of comfort in relation to their temperature.

Conclusion and perspectives

By increasing the investigators knowledge on Bairhuggers Full Access Underbody blanket and its effects in preventing hypothermia as well as gaining insight to patients´ experiences of comfort in relation to temperature, the investigators anticipate to improve pre-anesthetic care and minimize risk factors associated with hypothermia for patients undergoing major spinal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients for elective major spinal surgery
* Patients ≥ 14 years
* Danish language

Exclusion Criteria:

* Patients\> 110 kg
* Patients with a temperature \> 37.5 ° C
* Patients with a temperature ≤ 35 ° C
* Cognitive impairment to such an extent that the patient does not understand the purpose of, nor is able to cooperate, with the project
Modifying a Telephone Based Care Program to Assess for Self-Neglect

The purpose of this study is to assess the feasibility of enrollment, attrition, and adherence of Benjamin Rose Institute Care Consultation (BRI-CC) on unmet needs in low-income older adults who screen positive for dementia and their caregiver (CG).


Eligibility Criteria:
Inclusion Criteria:

* able to provide consent and understand English since most of the measures have not been translated into other languages
* has a CG willing to participate, specifically the CG must provide assistance in personal care, daily living tasks, and/or healthrelated decisions at least 3 hours per day and at least 3 days per week
* screen positive for dementia.

Exclusion Criteria:

* participant who receives home-delivered meals plans to relocate to long-term care prior to study enrollment
* reportedly moving out of the catchment area during the proposed study period
* non-English speaking
* unable to provide informed consent
* pre-diagnosed terminal illness
* non-working telephone
* visual impairment inhibiting the dyad from reading the instruments
Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation

In China, free first-line ART regimens typically consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTI). As of the end of 2022, approximately 1.135 million individuals were receiving ART, achieving a coverage rate of 92.8%, largely due to participation in free treatment programs. However, around 36,000 patients have discontinued treatment, primarily due to side effects associated with Efavirenz (EFV), a common NNRTI. The challenges posed by side effects and resistance profiles of existing NNRTIs highlight the need for effective re-initiation of ART to improve overall treatment coverage. INSTIs, particularly B/F/TAF (Bictegravir/emtricitabine/tenofovir alafenamide), demonstrates effective viral suppression and a higher barrier to resistance than NNRTIs. B/F/TAF has shown efficacy in patients with resistance mutations, making it a strong candidate for same-day ART re-initiation, especially in resource-limited areas where genotypic resistance testing may be unavailable. This study aims to evaluate the feasibility and effectiveness of rapidly restarting B/F/TAF in patients with treatment interruptions from previous NNRTI regimens.


Eligibility Criteria:
Inclusion Criteria:

* Patients with 18 years old or above.
* Discontinuation of previous NNRTI based regimen for more than 90 days.
* No known CrCl\< 30mL/min or severe hepatic impairment.
* No known or suspected resistance to BIC.
* No known pregnancy

Exclusion Criteria:

••Patients who are pregnant.

* Patients who have abnormal liver and kidney function indicators(Child-pugh class C, CrCl\< 30).Hepatitis virus co-infection does not serve as an exclusion criterion.
* Patients who have historic resistance test indicating drug resistant to BIC or baseline resistance test indicating resistance to BIC.
* Patients who are psychiatric illness or active tuberculosis co-infection.
Qualitative Evaluation of Tear Fluid and Blood for Auto Antibodies Produced in Response to COVID-19

This study objective is to collect tear and blood samples from individuals with positive SARS-COV2 diagnosis and test those samples for the presence of various SARS-COV2 viral antigens and autoantibodies.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older Has been tested for SARS-CoV2 and awaiting results Sample collection for SARS-CoV2 testing Tested positive for SARS-CoV2 virus (confirmed by RT-PCR) prior to enrollment

Exclusion Criteria:

* Under 18 years of age Concurrent eye infection or trauma unrelated to presence of SARS-CoV2 virus. Advanced COVID-19 state what would preclude safe and feasible sample collection.
The Expression of Serum Angiogenesis Marker in Patients Presenting With Hemoptysis

Vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) are major mediators of angiogenesis and are induced by tissue inflammation and hypoxia. While elevated serum VEGF levels have been reported in inflammatory lung diseases, especially with hemoptysis, there was no study to evaluate the Ang-2 levels in lung inflammatory diseases according to the presence of hemoptysis, inflammatory biomarker and hypoxia.


Eligibility Criteria:
Inclusion Criteria:

* patients visited Samsung Medical Center for the treatment of benign inflammatory disease such as bronchiectasis, aspergilloma, pneumonia and post-tuberculosis destroyed lung

Exclusion Criteria:

* patients with tumorous condition including lung cancer, vasculitis and the lung disease associated with collagen vascular disease on the point of enrollment
Verticality Perception - Multisensory Contribution

The purpose of this study is to evaluate the relative contribution of head- and trunk-based sensory systems to internal estimates of direction of gravity in healthy human subjects. To implement this assessment experimentally, the investigators will use a motor-driven 3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted (±30°) or aligned with the trunk. The investigators will then obtain measurements of the subjective visual vertical in seven different whole-body roll positions (max. 90° roll-tilt). Analysis will be driven by a state-of-the art Bayesian integration model. The investigators hypothesize that different sensory input signals are combined in a statistically optimal fashion.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-60 years
* informed consent
* absence of exclusion criteria

Exclusion Criteria:

* peripheral-vestibular deficit
* disturbed consciousness
* history of sensory deficits
* visual field deficits
* other neurological or systemic disorder which can cause dementia or cognitive dysfunction
* intake of antidepressants, sedatives, or neuroleptics
* pregnancy, unless excluded by a negative pregnancy test
* known neck pain or status post neck trauma
Early Childhood Caries and Health Professionals' Perception: a Qualitative Research Protocol to Assess Oral Health Stigma

Dental caries is the most common non-communicable disease in childhood. Disease management of caries rests on surgical treatment as well as various preventive strategies such as fluoridation, sealants, personal counselling...

With other non-communicable diseases (obesity, overweight...), it has been demonstrated that health professionals' negative perceptions of their patients could affect disease management quality. Concerning dental caries, some data might suggest that discriminating believes and behaviours toward children with dental caries and their families exist in the medical setting. However, oral health related stigma remains an unexplored issue. This study would be the first to our knowledge to specifically address the question of stigmatisation and discrimination of patients with dental caries. The present project is to conduct an exploratory study focusing on perceptions and attitudes of health professionals toward children with early childhood caries and their parents.

The questions the study aims to answer are: (i) What are health professionals 'perceptions of children with ECC and their family? And (ii) according to health professionals, do these perceptions influence the quality of their care? We hypothesize that some practitioners have negative opinions on children with ECC and their parents, affecting the quality of their care, especially concerning oral health prevention.

Method: Individual semi-structured interviews will be conducted among dentists (general or pediatric), general practitioners and paediatricians.


Eligibility Criteria:
Inclusion Criteria:

* speak French fluently
* practice with children as a dentist (general or pediatric), a general practitioner, or a paediatrician
* work in hospital or ambulatory facility

Exclusion Criteria:

* NA
Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients

Humans have a remarkable ability to flexibly interact with the environment. A compelling demonstration of this cognitive flexibility is human's ability to respond correctly to novel contextual situations on the first attempt, without prior rehearsal. The investigators refer to this ability as 'ad hoc self-programming': 'ad hoc' because these new behavioral repertoires are cobbled together on the fly, based on immediate demand, and then discarded when no longer necessary; 'self-programming' because the brain has to configure itself appropriately based on task demands and some combination of prior experience and/or instruction. The overall goal of our research effort is to understand the neurophysiological and computational basis for ad hoc self-programmed behavior. The previous U01 project (NS 108923) focused on how these programs of action are initially created. The results thus far have revealed tantalizing notions of how the brain represents these programs and navigates through the programs. In this proposal, therefore, the investigators focus on the question of how these mental programs are executed. Based on the preliminary findings and critical conceptual work, the investigators propose that the medial temporal lobe (MTL) and ventral prefrontal cortex (vPFC) creates representations of the critical elements of these mental programs, including concepts such as 'rules' and 'locations', to allow for effective navigation through the algorithm. These data suggest the existence of an 'algorithmic state space' represented in medial temporal and prefrontal regions. This proposal aims to understand the neurophysiological underpinnings of this algorithmic state space in humans. By studying humans, the investigators will profit from our species' powerful capacity for generalization to understand how such state spaces are constructed. The investigators therefore leverage the unique opportunities available in human neuroscience research to record from single cells and population-level signals, as well as to use intracranial stimulation for causal testing, to address this challenging problem. In Aim 1 the investigators study the basic representations of algorithmic state space using a novel behavioral task that requires the immediate formation of unique plans of action. Aim 2 directly compares representations of algorithmic state space to that of physical space by juxtaposing balanced versions of spatial and algorithmic tasks in a virtual reality (VR) environment. Finally, in Aim 3, the investigators test hypotheses regarding interactions between vPFC and MTL using intracranial stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects include both male and female patients, between 10 years of age and 64 years of age, who undergo placement of intracranial electrodes for clinical characterization of epilepsy.

Exclusion Criteria:

* Grounds for exclusion would include inability to understand and follow instructions, or inability to concentrate sufficiently to achieve a high proportion of correct responses.
Novel Mechanisms and Predictors of VEGF Receptor Inhibitor- or Immune Checkpoint Inhibitor-Associated Hypertension and Cardiovascular Disease

The purpose of this study is to understand the effect of vascular endothelial growth factor tyrosine kinase (VEGF) inhibitor, immune checkpoint-inhibitor (ICI), and combination treatment on blood pressure and blood vessel function.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 40 - 75 years old
* Diagnosis of cancer
* Receiving VEGF inhibitor, ICI, or combination (VEGF inhibitor + ICI or combination ICI) treatment, or not receiving any treatment.
* Normal blood pressure or blood pressure treated to \< 140/90 mm Hg with ≤2 antihypertensive medications

Exclusion Criteria:

* Presence of peripheral artery disease
* History of a heart attack within 1 year
* History of a stroke within 1 year
* Diabetes
* Life expectancy \< 3 months
* Women who are pregnant
* Women who are nursing
Observational Study of Hemiplegic Shoulder Pain After Recent Stroke

This is an observational study to address the following questions.

1. How many people develop stroke-shoulder pain within 3 days of stroke?
2. How many people have stroke shoulder pain at 8-10 weeks after stroke?
3. Does having stroke-shoulder pain within 3 days of stroke predict the likelihood of having stroke-shoulder pain at 8-10 weeks?
4. What are the best bedside examination tests to identify stroke-shoulder pain?

Patients will be assessed very early after stroke (within 72 hours) and followed up 8-10 weeks later. Findings will enable planning of fully-powered randomised controlled trials of both, pain-prevention strategies and treatment.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of haemorrhagic or ischaemic stroke

Exclusion Criteria:

* Transient Ischaemic attack,
* Neurological symptoms due to causes other than acute stroke,
* Unconscious,
* Severe behavioural disturbance,
* Severe agitation,
* Severe dementia,
* For palliation,
* Totally unable to communicate using any method - written, verbal, pictures, gesture
Ultra Rapid Culture Independent Detection of High-Priority Carbapenem Resistant Enterobacteriaceae Directly From Blood

The purpose of this study is to develop a new and very rapid diagnostic test for identifying a certain type of bacteria called Enterobacteriaceae in blood. Rapid identification of bacteria will assist in decreasing the use of antibiotics and help more patients survive bacterial infections of the blood.

It is our overall goal to develop a new diagnostic technology that will facilitate antibacterial stewardship to reduce selective pressure and improve patient outcomes. The Institute of Medicine has identified antibiotic resistance as one of the key microbial threats to health in the United States and has prioritized decreasing inappropriate use of antimicrobials as the primary solution to address this threat. The emergence of carbapenem resistance among Enterobacteriaceae (CRE) in the United States represents a recent and severe byproduct of excessive antimicrobial use with a high mortality rate in bacteremia. A major barrier toward decreasing use of antimicrobials is lack of sensitive and accurate rapid diagnostic tests for identifying bacterial etiologies of infection.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmed gram negative bacilli blood culture

Exclusion Criteria:

* Pregnancy
* Prisoner
Written Disclosure Therapy for Anxiety and Stress in Patients With Chronic Lung Disease

The purpose of this study is to determine whether Written Disclosure Therapy (WDT) is of any benefit to patients with chronic lung diseases who are participating in pulmonary rehabilitation.

Chronic lung diseases are typically associated with impaired quality of life, stress, and anxiety. Written disclosure therapy (WDT) reduces stress in patients with a variety of chronic illnesses. We sought to determine if written disclosure therapy benefits patients with chronic lung diseases when it is added as a component to the pulmonary rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD or Pulmonary Fibrosis
* First time participants in Pulmonary Rehabilitation program

Exclusion Criteria:

* Dementia
* Prior significant psychiatric illness
* Inability to complete the questionnaires
* Inability cooperate with spirometry
* Inability or to participate in outpatient follow-up over the six-month
Wearable Blood Pressure Devices to Identify Masked Uncontrolled Hypertension.

Uncontrolled out-of-office blood pressure (BP), measured by either home BP monitoring (HBPM) or ambulatory BP monitoring, has been shown to predict higher cardiovascular risk. However, HBPM could not identify daytime BP surge, which leads to underestimation of future risk among treated hypertensive individuals.

HeartGuide provides validated out-of-office BP measurements, along with activity/sleep recordings. The present study is designed to examine whether BP monitoring with the HeartGuide could identify masked uncontrolled hypertension in controlled hypertensive patients based on office BP. We will enroll hypertensive patients with controlled office BP according to their cardiovascular risk profile. We will also examine prevalence of post-prandial BP changes and BP variability using HeartGuide.

Recent hypertension guidelines stressed the importance of out-of-office BP monitoring. Ambulatory BP (ABPM) and home BP monitoring (HBPM) both predict future cardiovascular events better than office BP. Masked hypertension is an important issue. As revealed by recent studies, daytime BP surge can result in greater target organ damage for high-risk hypertensive individuals.

Previous trials such as TASMINH2 and TASMINH-SR study showed positive effects of HBPM on BP control in hypertensive patients. However, several issues preclude perfect applications of HBPM. For example, HBPM could not provide BP recordings during activity or at night-time. In addition, the currently recommended time schedule for HBPM may be insufficient for detecting daytime surge especially among high-risk individuals. Wearable BP devices seem to fill in this gap as a novel approach of out-of-office monitoring.

HeartGuide, the new watch BP monitor, was recently validated to provide accurate BP measurements. It could provide incremental knowledge with potentially larger numbers of recordings. The primary objective of this study is to unveil uncontrolled masked hypertension with HeartGuide, particularly for those undetected with current office BP and HBPM. A second objective is to assess diurnal BP trends and BP variability.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign informed consent form
* Currently taking anti-hypertensive therapy for more than 3 months
* Drugs are unchanged during the study period
* Office BP below 140/90 mmHg at least one visit

Exclusion Criteria:

* Diagnosed with terminal illness
* End-stage renal disease requiring lifelong dialysis treatment
* Patients with impaired performance status (ECOG \>= 2)
* Women undergoing or expecting pregnancy during the study period
* Resistant hypertension (taking more than 4 kinds of anti-hypertensive drugs)
* Known atrial or ventricular arrhythmia
* Wrist circumference out-of range between 13.5 to 21.5 cm
A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity

The purposes of this study are to find out whether dextromethorphan can prevent the short or long-term neurologic side effects of methotrexate, and whether dextromethorphan can improve symptoms of short-term neurologic side effects if they do occur.

We believe that we are beginning to understand the biological cause of the neurotoxicity that happens after treatment with methotrexate. Dextromethorphan, an ingredient in common cough medicines, may be able to prevent and/or treat this neurotoxicity. We have given dextromethorphan to a small group of patients who developed severe neurologic side effects after methotrexate. All had a complete recovery within one day.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed acute lymphocytic leukemia (ALL), non-Hodgkin's lymphoma (NHL) or OS. Patients will be separately stratified and randomized by disease.
* Patients with history of seizures are eligible but will be stratified separately.

Exclusion Criteria:

* Patients taking monoamine oxidase inhibitors (MAOIs) will be excluded from the study, because of the risk of severe drug interactions.
* Pregnant or lactating women.
S100B in the Care of Non-traumatic Headaches in the Emergency Department

The main objective of this pilot study is to make a first assessment of the discriminating ability of a dosage of S100B protein for differential diagnosis between primary headaches and secondary headaches.

For this, the investigators will compare serum S100B protein between two groups of headache patients presenting at the emergency department: 1 group of primary headache patients and 1 group of secondary headache patients.

If the difference between the two groups proves potentially discriminating, the investigators will seek to determine the discriminating ability of the S100B protein by calculating the area under the ROC curve.

The reference diagnostic will be set at one month across the entire clinical picture and imaging by an expert committee composed of a neurologist, a radiologist and an emergency physician.

The secondary objectives of this study are:

A. To seek an association between S100B protein levels and the onset of pain depending on whether it is more or less than 3 hours.

B. To assess the association between S100B protein levels and mortality at day 28.

C. To evaluate the association between S100B protein levels and hospital care: average length of stay in the emergency department, lumbar puncture, brain imaging, average length of hospital stay.

D. To evaluate the prognostic value of determination of S100B protein on the occurrence of a secondary headache at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has nontraumatic headache pain with a visual analog scale \> 3

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a contraindication for magnetic resonance imaging
* Patients suffering from the following diseases: Alzheimer's disease, multiple sclerosis, Creutzfeldt-Jakob disease, melanoma, trisomy 21.