cyrilzakka/clinical-trials huggingface dataset:
Tandem VR: Synchronized Nature-Based Experiences in Virtual Reality for Hospice Patients and Their Caregivers

Background: Nature-based virtual reality (VR) and other outdoor experiences in head-mounted displays (HMDs) offer powerful, non-pharmacological tools for hospice teams to help patients undergoing end-of-life (EOL) transitions. However, the psychological distress of the patient-caregiver dyad is interconnected and highlights the interdependence and responsiveness to distress as a unit. Hospice care services and healthcare need strategies to help patients and informal caregivers with EOL transitions.

Methods: This study uses a synchronized Tandem VR approach where patient- caregiver dyads experience immersive nature-based and other outdoor VR content. This mixed methods study will recruit 20 patient-caregiver dyads (N = 40) enrolled in home hospice services nearing the end-of-life. Dyads will experience a personalized nature-based or other outdoor VR experience lasting 5-15 minutes. Self-reported questionnaires and semi-structured interviews will be collected before and after the VR intervention to identify the impacts of personalized nature-based and other outdoor Tandem VR experiences on the QOL, pain, and fear of death in patient-caregiver dyads enrolled with hospice services. Additionally, this protocol will determine the acceptance of personalized nature-based and other outdoor Tandem VR experiences by dyads as a non-pharmacological modality for addressing patient and caregiver needs. Acceptance was quantified by the number of dyads accepting or declining the VR experience during recruitment.

Discussion: Using personalized, nature-based and other outdoor VR experiences, the patient-caregiver dyads can simultaneously engage in an immersive encounter to help alleviate symptoms associated with declining health and EOL phases for the patient and the often overburdened caregiver. This protocol focuses on meeting the need for person- and caregiver-centered, non-pharmacological interventions to reduce physical, psychological, and spiritual distress.

Eligibility Criteria:
Inclusion criteria:

* English speaking
* Projected life expectancy of \<6 months (established by hospice experts)
* Cognitively intact (has sufficient judgment, planning, organization, and self-control)

Exclusion criteria:

* Having a cognitive impairment that affects protocol participation. This will be done with the assistance of Research Recruiters to assess eligibility.
* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset
* Have a prognosis of hours or actively dying at the time enrollment
* Patients with motion sickness
* Patients with claustrophobia
* Patients with visual and hearing impairment
* Patients with inability to speak English
VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis

The VITRO (Vitamins and Thrombosis) study investigated the effect of homocysteine lowering by daily supplementation of B-vitamins on the risk reduction of deep-vein thrombosis and pulmonary embolism. Patients between 20 to 80 years old with a first objectively confirmed proximal deep-vein thrombosis or pulmonary embolism in the absence of major risk factors and a homocysteine concentration above the 75th percentile of a reference group were asked to participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of patients with a homocysteine below the 75th percentile of the reference group (normohomocysteinemic group). After informed consent patients were randomized to daily multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin) or placebo and were followed for 2.5 years. End-points were objectively diagnosed recurrent deep-vein thrombosis or pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* objectively confirmed proximal deep-vein thrombosis or pulmonary embolism
* idiopathic thrombosis (i.e. absence of major risk factors (major surgery, known malignant disease, pregnancy and puerperium or immobility for more than three weeks)
* age between 20 to 80 years

Exclusion Criteria:

* obligatory use of vitamin B
A Clinical Evaluation of Wear Couples in THA

Clinical evaluation of 4 different bearings in THA. Primary parameter being prosthetic survival data.


Eligibility Criteria:
Inclusion Criteria:

* \>18 Willing to participate informed consents indication for THA

Exclusion Criteria:

* \<18 other diseases in the lower extremities than the actual disorder of the hip
3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals

This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the three years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.


Eligibility Criteria:
Inclusion Criteria:

* Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain).
* A minimum of 18 months on antipsychotic treatment.
* Meeting clinical remission criteria for at least the 12 months prior to inclusion.
* Meeting the functional recovery criteria for at least the 6 months prior to inclusion.
* Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.

Exclusion Criteria:

* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence.
* Meeting DSM-IV criteria for mental retardation.
* Having a history of neurological disease or head injury.
Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery

The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE.

• Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure?

Participants will be asked to undergo a TACE procedure, a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures.

Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs. pressure-modulated catheter delivery. Lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged \>18 years.
* Plan to undergo lipiodol TACE for HCC or NET liver metastases
* Bilobar disease or distribution for which staged therapy (more than one TACE) for distinct target tumors is planned
* Liver tumor burden does not exceed 50% of the liver volume
* Patent main portal vein
* Life expectancy of greater than 6 months
* ECOG performance status 0-2
* Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl
* Adequate marrow and renal function as defined as:
* Platelets \>75,000/mcL (may be corrected by transfusion)
* Serum creatinine \< 2.0 mg/dl
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such contraception from beginning of study treatment until 1 month following last TACE treatment, as recommended for TACE treatments not conducted within the trial.
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner from first study treatment until 1 month following last TACE treatment.
* Provision of signed and dated informed consent form and ability to consent for oneself.
* Stated willingness to comply with all study procedures and availability for the study duration.

Exclusion Criteria:

* Absolute contraindication to contrast-enhanced MRI
* Absolute contraindication to intravenous iodinated contrast, including history of previous severe contrast reaction or moderate reaction not mitigated by appropriate pre-medication
* Pregnancy or lactation
* Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model

This study aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for this study utilize "technology-based approaches" for "implementing large-scale change." Leveraging previous data focused on developing and testing the 8-staged Stages of Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase and testing the SIC-CS to support the adoption of new evidence-based programs.


Eligibility Criteria:
Inclusion Criteria:

* Senior leadership staff from teams that either currently are sustaining or who achieve 1-year sustainment post certification during the first year of the project

Exclusion Criteria:

* none
Bilateral Upper Limb Amputation Observatory

In France, there is currently no data to directly estimate the number of bilateral upper limb amputations, their characteristics and therapeutic care.

By extrapolation from the Regional Institute of Physical Medicine and Rehabilitation (PMR) Nancy in 2005, the number of new cases of amputated patients with prosthetic fitting of the upper limb was estimated at 355. Epidemiological data from the 2009-2010 Annual Report of the LIMBLESS STATISTICS database (collection of quantitative clinical data and demographic of amputees patients referred by orthopaedic centres in the United Kingdom , whose population's characteristics are similar to France) identified 395 incident cases of upper limb amputation with, 6 bilateral amputations observed. The causes are varied: traumatic, infectious or related to diabetes. The population was relatively young, aged between 15 and 54 year old.

On this basis, the estimated number of new cases of bilateral upper limb amputations throughout France should therefore be about 40 incident cases over a 5-year period.

This observational study is aimed at collecting comprehensive and high quality data to describe the French population of bilateral upper limb amputees.


Eligibility Criteria:
Inclusion Criteria:

All French patients :

* presenting bilateral upper limb amputation, from short transverse amputation of the hand (hand not fully functional) to arm amputation;
* affiliated with a social security scheme or assimilated;
* who have given their non-opposition to participate in the study.

Exclusion Criteria:

* Patients with finger amputation only;
* Patients already having prosthesis of one upper limb (first amputation) and willing to receive prosthesis fitting after a contralateral amputation
Acanthamoeba and Artificial Intelligence

Acanthamoeba keratitis, caused by the pathogen Acanthamoeba spp, is recognized worldwide as a severe ocular infection that can pose potential risks to vision.

This observational retrospective and single-center study, of exploratory nature, aims to determine the possibility of identifying patterns that may be useful for future rapid diagnosis of Acanthamoeba keratitis from confocal images, leveraging the normality of corneal examination and the high specificity and sensitivity of computational models.

The data will be based on patients who have been confirmed positive through laboratory tests with proven effectiveness in detecting the infection.

The laboratory tests considered for the division of patients into their respective groups are bacterial examination, PCR examination, and culture examination.

Patients were divided into two groups, the first comprising patients positive for Acanthamoeba infection, while the second comprised patients negative for Acanthamoeba but positive for other pathogens. The study will last for 18 months.

The cohort under study includes 151 patients from the IRCCS San Raffaele Hospital who underwent the aforementioned examinations, of which 76 cases will be included in the group of patients positive for Acanthamoeba and 75 in the group of controls positive for other pathogens.

The confocal images of this cohort will be fed into artificial intelligence software. To evaluate the model, the test set will be used, and the AI model's ability will be assessed using the most commonly used metrics in the field of computer vision such as accuracy, specificity, sensitivity, and f1-score; culminating in a comprehensive evaluation of the model.


Eligibility Criteria:
Inclusion Criteria:

* Performed corneal scraping and subsequent bacterioscopic exam, PCR and bacterial colture analysis between 2004 and 2023.
* Patients positivity to corneal infection.

Exclusion Criteria:

- Patients negativity to aforementioned exams.
An Investigation Into the Dispersion Pattern During Coughing and Open Nasopharyngeal Suction Using Various Barrier Devices

The aim of the study is to examine the air dispersion pattern and the environmental influence of open airway suction in general ward setting. Secondly, the study is aimed at identifying a simple \& practical enclosure device in general ward. Suction will be performed in manikin in supine lying.

Nasopharyngeal suction will be performed by physiotherapist with working experience more than 1 years. Besides, surgical mask \& enclosure tent will be adopted as the enclosure barrier device in this study.

Research Question

1. To assess the extent of the environmental contamination during coughing and simulated airway suction
2. To measure the air particle count during coughing and simulated open airway suction.
3. To evaluate how effective the enclosure barrier in reducing the air particle dispersion during open airway suction.


Eligibility Criteria:
Inclusion Criteria:

* physiotherapists with working experience more than one year

Exclusion Criteria:

* physiotherapists with working experience less than one year
Treating Smokeless Tobacco Use in Rural Veterans

This is a pilot study designed in an effort to develop and improve access to effective treatments for tobacco use in rural Veterans using a tailored intervention approach. Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco users including elevated depressive symptoms, risky alcohol use, and concerns about weight gain. The objectives are to:

1. Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users
2. Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.


Eligibility Criteria:
Inclusion Criteria:

1. Use smokeless tobacco on a daily basis
2. Be willing to make a quit attempt in the next 30 days
3. Reside in a rural location
4. Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic
5. Able to provide informed consent
6. Telephone access
7. Stable residence

Exclusion Criteria:

1. Planning to move in the next 12 months
2. Terminal illness
3. Unstable psychiatric disorder
4. Incarcerated
5. Institutionalized
Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue

The purpose of this study is to see whether the use of AMNIOEXCEL® improves healing and reduces the need to cut off all or part of a leg (amputation) in high-risk patients who have diabetes and foot sores (also sometimes called ulcers or wounds).

The purpose of this study is to demonstrate the effectiveness of comprehensive, interdisciplinary approach (usual care) in combination with early application of advanced therapy; dehydrated human amniotic membrane allografts (AMNIOEXCEL®, Derma Science, Princeton, New Jersey) in healing and preventing amputation in high risk patients with diabetic foot ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 diabetes
* Ulcer anywhere on the foot
* Moderate to high risk for amputation according to Prevention of Amputation for Veterans Everywhere (PAVE) and the Society for Vascular Surgery Lower Extremity Threatened Limb (SVS WIfI) classification system (WIFi) criteria

Exclusion Criteria:

* Inability or unwillingness to travel to Boise VA for clinic visits
* Enrolled in Hospice
* Have known or expected malignancy of foot ulcer
* Are or planning to become pregnant
* Signs of progressive gangrene, limb-threatening infection
Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations:

The main purpose is to compare overall alignment time (OAT) in days in alleviating mandibular incisors crowding between control group and MOPs group.Furthermore, to investigate the presence of volumetric root resorption from CBCT, gingival recession and formation of black triangle post lower labial segment alignment between micro-osteoperforations group and control group.

Prolonged treatment time in orthodontics is an undesirable side effect for both the patient and clinician. Usually, an average course of comprehensive orthodontic treatment with fixed appliances requires less than 2 years to complete (19.9 months). This prolonged treatment time may cause adverse effects such as root resorption, gingival recession, caries \& enamel demineralization. Micro-osteoperforations is safe, minimally invasive technique which perforations are performed through the gum tissues, penetrating the bone without the need to raise a ﬂap.Control group will not received any MOP and will receive standard orthodontic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Gender : Male and Female
* Age range : ≥ 18years to 45 years old
* Crowding of 3mm - 7mm on lower labial segment (lower right canine to lower left canine) which does not require extractions in the lower arch
* Class II div I Incisor relationship with extraction of both upper 1st premolars
* Maximum anchorage control with temporary anchorage device ( TAD) , with Molar Class II (¼ to full unit) malocclusion
* Average vertical facial proportions
* No systemic disease
* Acceptable good oral hygiene
* No periodontal disease

Exclusion Criteria:

* Smokers
* Distally angulated canines
* History of trauma (crown fracture or avulsion and re-implantation) , endodontic treatment
* Missing permanent mandibular anterior teeth ( Hypodontia) / Retained deciduous teeth in mandibular anterior area
* Habits eg: fingernails biting , toothpick user , using hard toothbrush
* Vertical skeletal discrepancies eg high angle and low angle
* Systemic disease especially on long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers
* Poor oral hygiene for more than 3 visits
* Current periodontal disease
A Study of LY3209590 in Participants With Type 2 Diabetes

This study will evaluate the safety and tolerability of LY3209590 when given by injection under the skin to participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects will be documented.

This study will last approximately 17 weeks, not including screening. Screening is required within 4 weeks prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year
* Have a glycated hemoglobin (HbA1c) greater than or equal to (≥) 7.0 percent (%) to less than or equal to (≤) 10.5% at screening
* Have had no episodes of severe hypoglycemia in the past 6 months
* Are on stable basal insulin (neutral protamine Hagedorn insulin suspension \[NPH\] insulin, insulin glargine \[U100 or U300\], or insulin detemir) with or without metformin, dipeptidyl peptidase IV (DPP-IV) inhibitors, sulfonylureas, and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, at a stable dose for at least 3 months before screening

Exclusion Criteria:

* Have significant lipohypertrophy in the target abdominal injection
* Have a history of renal impairment
* Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children)
* Have proliferative retinopathy or maculopathy and/or severe neuropathy
* Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening
* Require daily insulin treatment less than (\<) 0.15 unit/kilogram (U/kg) per body weight
* Are treated with a continuous subcutaneous insulin infusion (CSII) pump
* Currently receiving degludec insulin therapy, or have been treated with degludec within the past 90 days
Is it Possible to Screen for Type 2 Diabetes at Day 2 in Gestational Diabetes Mellitus Patients Postpartum?

Within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. However, not all women are screened. The objective of this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity, false and true predictive values of the screening test at 48 hours post-partum compared to the gold-standard.


Eligibility Criteria:
Inclusion Criteria:

* Dx of gestational diabetes treated with insulin
* To be in post-partum
* Delivery of a baby of at least 37 weeks of gestation
* Have signed the consent form

Exclusion Criteria:

* History of glucose intolerance of diabetes before the pregnancy
* Obstetrical pathology during pregnancy
High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea

High flow nasal cannula (HFNC) ventilation therapy was found to improve the severity of obstructive sleep apnea in non-stroke subjects. The investigators hypothesized that HFNC might be effective in stroke patients with dysphagia who needed nasogastric tube feeding and can not receive continuous positive airway pressure ventilation for obstructive sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke patients with dysphagia and obstructive sleep apnea who need nasogastric tube feedings

Exclusion Criteria:

* congestive heart failure, unconsciousness, chronic obstructive pulmonary disease, intracranial hemorrhage or malignancy, and unstable medical and neurological conditions
* central sleep apnea