cyrilzakka/clinical-trials huggingface dataset:
Use of White Granulated Sugar on Wounds

How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating wounds compared with standard treatment?

Patients for whom all the following apply:

Have an exudating wound sizes 5cm2 and 40cm2 A minimum of 25% slough, infected and necrotic tissue No dry necrotic eschar present Ankle Brachial Pressure Index of greater than 0.6 Are over 18 years Independently and willingly consent

Eligibility Criteria:
Inclusion Criteria:

* Exudating wound sizes 5cm2 and 40cm2
* A minimum of 25% slough, infected and necrotic tissue
* No dry necrotic eschar
* Ankle Brachial Pressure Index of greater than 0.6
* Age over 18 years
* Able to independently and willingly consent

Exclusion Criteria:

* Participants in a trial evaluating other therapies for their wound
* Have previously been in this trial
* Women who are pregnant
* Participants not able to tolerate daily dressing change
Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia

Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive after inguinal hernia are scarce and so far do not offer conclusive results. Aim of the study is to analyse reaction time and foot transfer time (together brake response time) and brake force in a brake simulator before and after scheduled inguinal hernia surgery (Liechtenstein procedure).


Eligibility Criteria:
Inclusion Criteria:

* scheduled surgery for inguinal hernia of the right groin with Lichtenstein procedure
* valid driving license
* male and female

Exclusion Criteria:

* lacking driving license
* pregnancy
* neuromuscular disorder (e.g. myopathy, muscular dystrophy)
* central neurological disorders/diseases (e.g. apoplexia, psychiatric diseases)
Forearm-Supported Head Extension to Decrease Dental Contact

The purpose of this study is to determine whether the forearm-supported head extension decreases dental contact between laryngoscope blade and maxillary incisors during direct laryngoscopy


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery that require endotracheal intubation for general anesthesia

Exclusion Criteria:

* Trauma or disease or cervical spine
* Toothless patient
* Dentoalveolar injury
* Anatomical anomaly of face or airway
* History of difficult intubation
* Patient refusal
Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications

Objective- The purpose of this study is to evaluate a connection between PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacuum drains of different plastic operational wounds and its relation to infections and seroma formation.

our objective is evaluation of a connection between PH,PCO2,HCO3,PO2,Na,K,Glu and Lactate patterns in vacum drains of different plastic operational wounds and its relation to infections and seroma formation.

it is possible that early changes in this values might point out an infection or seroma formation of a wound before clinical signs appear.

Eligibility Criteria:
Inclusion Criteria:

* all post operational patients who have a vacum drain/s

Exclusion Criteria:

* patients who are unable to sign a Consent Form (demented,Alzheimer's disease ...)
* patients who refuse participation
Immersive VR Reminiscence System for Facilitating Memory Retrieval Among Nursing Home Older Adults

A VR game "Memo-gration" was designed to assist elderly people in reminiscence therapy. The ultimate scene design was crafted in a vintage Chinese aesthetic reminiscent of the previous century.

This study tailored a variety of instructional material within each virtual scenario, taking into account various memory triggers. Guidance is activated when the user is identified as making physical contact with an object or discussing a specific keyword. This encompasses textual assistance provided within the virtual environment, the display of multimedia information, and the provision of organized voice guidance. Following the system's instructions, users engaged in discussion with the caregiver, and had the freedom to terminate the conversation at their discretion and explore other topics by interacting with different items.

Eligibility Criteria:
Inclusion Criteria:

* (i) absence of significant cognitive impairment, visual impairment, hearing impairment, and communication ability.
* (ii) Obtained the pre-test and watched the film while wearing a VR headgear without experiencing any notable discomfort.

Exclusion Criteria:

* (i) Older adults with cognitive impairments that prevent normal communication
* (ii) Visually impaired
Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport

A randomized controlled trial compared the clinical outcomes of transported pediatric patients monitored with an oscillometric blood pressure device versus those monitored with a near-continuous, noninvasive blood pressure.

94 transported patients were randomized to a control arm, monitored with a standard oscillometric blood pressure device (Dinamap), or an experimental arm, monitored with a near-continuous, noninvasive blood pressure device (Vasotrac).

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients transported by Angel One to Arkansas Children's Hospital.
2. Age Group: 1 year - 17 years AND
3. Patients at risk of developing SIRS (Systemic Inflammatory Response Syndrome), according to the criteria below.

   i. The presence of at least two of the following four criteria (one of which must be abnormal temperature or leukocyte count): A. Core temperature of \>38.5 C or \<36 C. B. Tachycardia, defined as mean heart rate \>95th percentile for age in absence of external stimulus, chronic drugs, or painful stimuli.

   C. Mean respiratory rate \>95th percentile for age, or \>10% immature neutrophils.

   OR
4. Patients with moderate or severe head trauma, at risk of developing secondary ischemic brain injury, according to the criteria below.

   i. Glasgow Coma scale \<15 with one or more of the following: A. Mass lesion or cerebral edema on CT or MRI scan. B. Post-Traumatic Seizure. C. Multiple Trauma. D. Focal Neurologic Signs. E. Intubation for control of suspected intracranial hypertension.

   -

Exclusion Criteria:

1. Wrist circumference less than 11cm (minimum size for the Vasotrac device).
2. Contractures of the wrists, not allowing correct placement of the Vasotrac device.
3. Hematoma(s) located on both wrists from recent redial (\<24hr) artery puncture.
4. Patients likely to proceed to brain death per assessment of the referring physician.
5. Patients being treated for malignant hypertension.
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.

The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent.
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
* Females who are permanently or surgically sterile or postmenopausal and males.

Exclusion Criteria:

* Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
* History of any convulsions or seizures
* History of infection or at risk of infection due to recent surgery or trauma
* History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug
Lumenate Observational Vasospasm Interventional Trial (LOVIT)

The LOVIT study is a European prospective, multi-center, open-label, single-arm feasibility trial designed to determine the safety and angiographic effectiveness through 30 days post treatment with Lumenate Intraluminal Device in the treatment of symptomatic vasospasm.

The Neurvana Lumenate Intraluminal Device is delivered via a percutaneous endovascular approach to the target segment for mechanical assistance and the treatment of vasospasm.

The LOVIT study is a European prospective, multi-center, open-label, single-arm feasibility trial designed to determine the safety and angiographic effectiveness through 30 days post treatment with Lumenate Intraluminal Device in the treatment of symptomatic vasospasm. The primary objective of the study is to support the CE-mark vasospasm label claim for the Lumenate Device. The study will be enrolled at up to 8 European sites with study subjects being followed for 90 days post-treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements
3. Patient has suffered SAH from a ruptured intracranial aneurysm
4. Has mWFNS ≤3 upon admission to the treating hospital or mWFNS ≤3 after insertion of an endoventricular drain (EVD) for acute hydrocephalus secondary to SAH.
5. Subject has provided written informed consent using the IRB/Ethics committee-approved consent form and are willing to comply with the study protocol and planned follow-ups.
6. Patients that develop symptoms of cerebral vasospasm, as determined by the physician, and/or have diagnostic (e.g. TCD) or radiological evidence of moderate/severe vasospasm.

Exclusion Criteria:

1. Patients that have angiographically confirmed (CTA/MRA) vasospasm at admission to the treating hospital
2. Subjects who require surgical treatment of culprit aneurysm.
3. Endovascular treatment of culprit aneurysm resulting in severe procedural complication (e.g., vessel rupture, embolization or other complication).
4. Placement of intraluminal stent or flow diverter is used to treat culprit aneurysm.
5. Intraluminal stent or flow diverter placed in the 6 months prior to culprit aneurysm rupture.
6. Treated with Intra Arterial vasodilators prior to Lumenate procedure
7. Receiving Anti-coagulant with half-life longer than 24 hours, or Dual antiplatelet therapy (DAPT) including P2Y12 inhibition
8. Woman of child-bearing potential who cannot provide a negative pregnancy test.
9. Patients with vasculitis or connective tissue disorders that put them at risk for vasculitis.
10. Known use of cocaine or methamphetamine within the last month.
11. Any comorbid disease or medical condition with a life expectancy ≤3 months.
12. Known allergy or contraindication to aspirin, heparin, local or general anesthesia
13. Known history of life threatening allergy to contrast dye
14. Serum creatinine ≥2.5 mg/dL
15. Enrollment in another trial involving an investigational product
16. Physician discretion that the patient may not benefit from treatment with Lumenate - reason for exclusion should be documented.
Mood Effects of Serotonin Agonists

The purpose of this study is to determine the effects of very low doses of serotonergic agonists on depressed mood in human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* English fluency
* High school level education
* BMI between 19 and 30

Exclusion Criteria:

* Diagnosed medical condition
* women who are nursing, pregnant, or plan to become pregnant within 3 months
* History of psychotic disorder or family history of psychotic disorder
Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis

This is a prospective, randomized controlled trial to evaluation the ability of 5-aminolevulinic acid HCL topical solution photodynamic therapy to decrease the colonization of Cutibacterium acnes (C. acnes- a bacteria commonly found in the dermis of the skin surrounding the shoulder) in order to decrease postoperative joint infections.

-Aminolevulinic acid (ALA) is a naturally occurring metabolite in the synthesis of pathway of cellular heme production. Adding ALA to bacteria encourages porphyrin production which serve as the immediate precursors to heme production. When these porphyrins are illuminated with blue light at an emission peak of 407-420nm, these metabolites become exothermic and cause internal destruction of the bacterial cells. This therapy does not cause any damage to the mammalian cells, which makes PDT safe for human skin treatment.


Eligibility Criteria:
Inclusion Criteria:

* All male patients (\>18) undergoing shoulder arthroscopy)

Exclusion Criteria:

* Female patients
* Patients with active acnes
* Patients who have taken antibiotics within a month of their surgery
* Subjects with psoriatic/eczematous lesions on the shoulder girdle
* Patients on anticoagulant therapy
* Patients who have a known allergy to any of the agents used in the study protocol
HFpEF and 2-year Mortality of COPD Patients

This study was designed to assess potential relationship between heart failure with preserved ejection fraction and 2- year mortality of patients with chronic obstructive pulmonary disease


Eligibility Criteria:
Inclusion Criteria:

Exacerbation of chronic obstructive pulmonary disease requiring hospitalization

Age 40 - 80 years

Performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG)

Long acting beta agonist (LABA)/ long acting antimuscarinic (LAMA) bronchodilator treatment

Exclusion Criteria:

Presence of major heart valve dysfunction

Documented noncompliance with treatment

Presence of active malignancy

Body mass index \> 40

Interstitial lung disease
PictureRx: An Intervention to Reduce Latino Health Disparities

The purpose of this randomized controlled trial is to evaluate the effect of Spanish-language illustrated medication instructions (PictureRx cards), compared to traditional medication instructions, on Latinos' understanding of their medication regimens. The study will also assess the effect on self-reported medication adherence. Patients with diabetes who attend participating clinics are eligible. The target sample size is 200.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes
* Latino, Spanish speaker
* Be at least 18 years old
* Must be taking at least 1 chronic medication

Exclusion Criteria:

* Too ill to participate in an interview
* Do not have a telephone
* Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart)
* Inability to communicate in either Spanish or English
* Overt psychiatric illnesses, overt delirium or dementia
Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old

As clinical and radiographic performance of an ultra-short anatomic cementless stem have been investigated only two randomized controlled studies, well-designed trials should aim for a thorough comparison of the outcomes of ultra-short and conventional cementless stems. The purpose of this study was to compare the outcomes of ultra-short and conventional stems in the same young patients who underwent simultaneous bilateral sequential total hip arthroplasties.

Conventional cementless femoral stems are known to provide a high rate of satisfactory clinical outcomes at long-term follow-ups. However, they may have potential clinical consequences related to stress shielding, thigh pain, periprosthetic fractures, proximal/distal dimensional mismatch, an easier access pathway for wear debries and removal during revision. In an effort to reduce the risk of stress shielding, thigh pain, periprosthetic fracture, proximal/distal stem mismatch, and to facilitate removal of well fixed stem, a new ultra-short anatomic metaphyseal-fitting cementless femoral stem was developed. It was designed to provide closely mimicking the original functioning hip. The absence of the diaphyseal anchorage attempt proximal load transfer to reduce stress shielding, thigh pain and proximal distal/mismatch. Furthermore, it attempts to preservation of the femoral canal and femoral elasticity and ease of revision. The question thus arises whether it is possible to obtain strong and long-lasting fixation of the femoral component without diaphyseal anchoring.

As clinical and radiographic performances of this ultra-short stem have been investigated only in a few studies and at short-term follow-ups, it remains to be elucidated whether an ultra-short stem shows a low incidence of implant loosening, stem misalignment, intraoperative fractures and revision rate. The purpose of this randomized controlled study to compare: (1) the clinical results, including Harris hip score, thigh pain, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index score, and patients' satisfaction; (2) radiographic results, including stress shielding, implant loosening, stem misalignment; and (3) intraoperative fractures and revision rates of cementless total hip arthroplasty using an ultra-short anatomic metaphyseal-fitting cementless femoral stem versus a conventional metaphyseal and diaphyseal fitting anatomi proximal porous-coated cementless stem in the same patients who underwent bilateral simultaneous sequential total hip arthroplasty under one anesthetic.

Eligibility Criteria:
Inclusion Criteria:

* End stage hip arthritis

Exclusion Criteria:

* Age above 50 years old
* Inflammatory arthritis
* Coexisting foot or ankle disorder limiting walking
Perioperative Immunonutrition, Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients

Perioperative immunonutrition in gastric cancer patients can reduce perioperative morbidity and may improve quality of their life. Patients with gastric cancer will be divided into four groups depending on the type of artificial nutrition. Group I (enteral feeding) and II (enteral feeding and parenteral nutrition with glutamine) will be administered nutritional therapy during the postoperative period, group III (oral arginine) and IV (parenteral immunonutrition) patients will be treated nutritionally both prior to and after the surgery. The lymphocytes and their subpopulations, interleukin IL-1B,-6,-23, and the phagocytic, and bactericidal activity of blood platelets will be determined before and after nutritional therapy.

Surgical treatment of gastric cancer is associated with a high risk of perioperative complications. Morbidity of cancer patients increases in concert with the clinical stage of the malignancy. It is postulated that a reduction in perioperative morbidity and improved quality of life of patients with advanced gastric cancer can be achieved by proper preparation to surgery, among others. One of such methods is the implementation of immunostimulating nutritional therapy during the perioperative period.The stage of cancer will be graded according to TNM classification. The patients will be randomly assigned to four clinical groups based on the type of nutritional therapy implemented.

Eligibility Criteria:
Inclusion Criteria:

* gastric cancer

Exclusion Criteria:

* for group III constituted gastric cancer associated with severe gastrointestinal obstruction
Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy

This is a multicenter, open-label, long-term, extension, phase 2 study to evaluate the safety and efficacy of long-term treatment with DS-5141b in patients with DMD who have completed DS5141-A-J101.


Eligibility Criteria:
Inclusion Criteria:

* Has competed a study of DS5141-A-J101

Exclusion Criteria:

* Significant safety issues in a study of DS5141-A-J101
* Patient who does not consent to use appropriate contraception
* Patient not appropriate to participant in the study as determined by the Investigator
Effectiveness of a Pain Science Education Programme in Adolescent Students.

The aim of this study is to analyze the effectiveness of a Pain Science Education program to improve the conceptualization of pain in adolescents between 11 and 13 years old, schooled in the first year of Compulsory Secondary Education.

Design:

Randomized controlled clinical trial. The primary endpoint of the study was pain conceptualization recorded by a questionnaire.

Setting:

The participants were school-age children attending a different high school in the province of Barcelona.

Participants:

Of the 450 potential school participants, 306 agreed to participate. 13 pupils were excluded when applying the eligibility criteria, so the resulting sample was of 293

Eligibility Criteria:
Inclusion Criteria:

* to be schooled at the El Cim school
* to be between 10 and 16 years old (both included)
* to have or have had pain in the last month; to be able to read and write in Catalan and/or Spanish.

Exclusion Criteria:

* had an intellectual disability and/or cognitive impairment that interfered with their participation
* had not submitted the informed consent form duly completed and signed by their legal guardians
Improved Detection of Myocardial Fibrosis: a Cardiovascular Magnetic Resonance Imaging Study

Myocardial fibrosis, or scarring, is a common endpoint in many cardiomyopathies and is associated with adverse outcomes, and precise tools to measure myocardial fibrosis are needed. Focal and diffuse myocardial fibrosis can be diagnosed by cardiovascular magnetic resonance (CMR) imaging. However, the CMR procedure is complex and time-consuming and require the use of intravenous gadolinium based contrast agents. A wide range of biomarkers have been associated with the diagnosis and prognosis of cardiovascular disease. In the current study the investigators will assess whether novel and established circulating myocardial biomarkers associate with myocardial fibrosis assessed by CMR. The investigators will also assess whether novel or improved CMR sequences as well as machine learning algorithms improve image quality and the detection of myocardial fibrosis.

This is an observational study of adult patients with suspected myocardial disease referred to cardiovascular magnetic resonance (CMR) with gadolinium contrast. The goal of the study is to assess whether novel and established circulating myocardial biomarkers associate with myocardial fibrosis assessed by CMR. The investigators will also assess novel techniques for detecting myocardial fibrosis by CMR. The plan is to include 1000 patients prior to CMR at Akershus University Hospital.

Blood samples for biomarker measurement will be obtained at the time of CMR. Image quality of novel CMR sequences will be recorded. The diagnostic results of the CMR will be compared to the levels of selected circulating biomarkers of myocardial injury and fibrosis. Novel sequences and techniques for assessing myocardial fibrosis by CMR will be compare to established techniques. Patients will be followed for a minimum of 12 months and the incidence of cardiovascular death, all-cause mortality, acute coronary syndromes, revascularization, heart failure, stroke and cardiac arrhythmias requiring rehospitalization will be recorded. Long-term follow-up information will be obtained from relevant registries

Eligibility Criteria:
Inclusion Criteria:

Consecutive adult patients referred for clinically indicated cardiovascular magnetic resonance (CMR) imaging with gadolinium contrast at Akershus University Hospital will be invited to participate.

Exclusion Criteria:

Participants with contraindication for gadolinium contrast or inability to consent will be excluded