cyrilzakka/clinical-trials huggingface dataset:
Redscar © Application for Detection of Infected Surgical Wounds

Surgical site infection (SSI) is the second cause of healthcare-associated infections (HAIs). Its appearance increase mobidity and post-operatice hospital stays, increasing costs aswell, although its one of the most preventable HAI.

The diagnosis and detection of SSI is usually carried out late by non-especialists once the patient has consulted to the emergency services or primary care with an already obvious infections. This raise both the direct and indirect costs and saturaties the emergency department and primary care, while delays treatment and increase disconfort and morbidity.

A smart phone aplication (RedScar© ) was developped in order to detect and monitor wound infection remotely based on an automated algorithm with no medical intervention.This app allows the patient to upload a photography and answer a short questionary, the aplication will then give a diagnosis of possible infection and recommendations.

This study is the first one to use a smartphone-based automatic aplication on real patients to diagnosis wound infection . This is a prospective, single-institution not randomized quasy-experimental study protocol. The study design and protocol were reviewed and approved by Research Ethics Committee of the Balearic Islands (CEI-IB).

This paper is part of the R+D+i Project PID2020-113870GB-I00- "Desarrollo de herramientas de Soft Computing para la Ayuda al Diagnóstico Clínico y a la Gestión de Emergencias (HESOCODICE)", funded by MCIN/AEI/10.13039/501100011033/.


Eligibility Criteria:
Inclusion Criteria:

* Signature of written consent.
* Age over 18 years.
* Emergency and scheduled surgery inpatients who have undergone abdominal surgery using staples to close the wound.
* Access to an android-based smartphone device, able to download the app and understand its management.
* Possibility of in person revision on the tenth postoperative day. Exclusion criteria
* Patients who do not have access to a compatible Smartphone or who are not able to use the app correctly (not being familiar with mobile devices or inability to understand how the app works or the questions asked).
* No written consent.
* Impossibility of personal revision.
Clinical Study of Patellar Resurfacing and Non-resurfacing in Total Knee Arthroplasty

The literature regarding resurfacing of the patella in total knee arthroplasty has conflicting conclusions. This study assesses medium-term clinical results of total knee arthroplasties performed with and without the patellar resurfacing in patients undergoing single-staged bilateral total knee arthroplasty in a randomized controlled, clinical study at a minimum of 5 years follow-up.

Sixty-six patients (132 knees) underwent primary single-staged bilateral total knee arthroplasty for osteoarthritis. Patients were randomized to receive resurfacing or retention of the patella. All patients received the Scorpio NRG knee prosthesis. Evaluations were done preoperatively and yearly, up to a minimum of 5 years postoperatively. Knee Society Score and Feller Score outcomes were measured. Anterior knee pain, the clunk of patella, and patient satisfaction questionnaires were completed.

Eligibility Criteria:
Inclusion Criteria:

* degenerative OA
* 50-75 years
* All patients with OA were bilateral knee OA

Exclusion Criteria:

* previous patellectomy
* inflammatory arthritis
* patellar fracture
* patellar instability
* previous extensor mechanism procedures
* high tibial osteotomy,
* severe valgus or varus deformity (\> 20°), severe flexion contracture (\> 30°)
* previous unicondylar knee replacement
* a history of septic arthritis or osteomyelitis.
Hand Position for Stylet Removal During Tracheal Intubation

Investigators compared the tube movement between two situations; the one was that the practitioner's hand holding the tracheal tube was placed in the air, and the other was that the hand was placed on the manikin's cheek, while two residents took the roles of the practitioner and the assistant in tracheal intubation with a stylet for a manikin.

Residents who accepted spontaneous participation were randomly combined into teams of two each. For two residents in a team, each sequentially took on the role of a practitioner and once as an assistant for tracheal intubations by changing the position of the hand holding the tube; one time, the position of the hand holding the tube was placed in the air, and the other time, the position of the hand holding the tube was placed on the cheek of the manikin. For the assistant role, residents performed stylet removal with two hands. Investigators filmed a video of the tube movement while the assistant pulling up the stylet at 1/8x speed. While analyzing the captured videos, it was measured how much the tube held by the intubation practitioner went in front or how far back during the process of pulling the stylet.

Eligibility Criteria:
Inclusion Criteria:

* residents in the department of Anesthesia and Pain Medicine

Exclusion Criteria:

* refusal for participation
Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer

This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A), S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs \>1), prior gastrectomy, and center.


Eligibility Criteria:
Inclusion Criteria:

* Non-prior chemotherapy treated advanced gastric adenocarcinoma
* Age 18 and over
* Performance status 0, 1, or 2 (ECOG)
* Life expectancy 3 months
* Hematopoietic WBC lower limit of normal-12,000/mm\^3 Absolute granulocyte count ≥ 2,000/mm\^3 Platelet count ≥ 100,000/mm\^3 Hemoglobin ≥ 8.0 g/dL
* Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
* Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

* Interstitial pneumonia, pulmonary fibrosis
* Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure
* Intestinal paralysis, intestinal obstruction, uncontrollable diabetes
Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer

Multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute safety of the FDA Cleared Axxent Electronic Brachytherapy System and vaginal applicator for intracavitary vaginal cuff treatment according to the physician's current standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Most types of endometrial (uterine) cancer Stage I and Stage II (see exclusion criteria below)
* Post hysterectomy

Exclusion Criteria:

* Endometrial (uterine) cancer Stage IA Grade 1
* Scleroderma
* Collagen vascular disease
* Active Lupus
Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (the SELLIFA Study)

The purpose of the study is to determine the role of new biomarkers in the diagnosis of sepsis in critically-ill patients with liver failure and to correlate the prognosis of these patients with parameters of endothelial function and lipid metabolism.

Early diagnosis of sepsis may be difficult in patients with severe liver failure in the absence of usual warning clinical signs. Furthermore, routine laboratory tests like blood leucocyte count and serum c-reactive protein may be misleading in most of these patients. A great interest is taken in the identification of sepsis biomarkers or sepsis-induced alterations in the inflammation cascade, whose expression is independent of liver function. Determination of such a biomarker may be a useful tool for the early diagnosis of sepsis and may have a prognostic significance in patients with liver failure.

Septic complications in patients with liver failure may induce a disruption of liver microcirculation, which is regulated by several factors acting on endothelial and liver stellate cells. Furthermore, generation of reactive oxygen species results in an oxidative stress on lipids, proteins, and DNA. Lipid peroxidation may contribute to further hepatocellular injury and activation of systemic inflammation cascade. Both endothelial dysfunction and alterations in lipid metabolism may have a role in the prognosis of liver disease and its complications.

The purpose of this prospective observational study is to determine the role of new biomarkers in the diagnosis of sepsis in critically-ill patients with liver failure and to correlate the prognosis of these patients with parameters of endothelial function and lipid metabolism. In addition, the porto-systemic gradient of these parameters will be determined in patients planned for a transjugular intra-hepatic porto-systemic shunt (TIPSS).

An overall number of 120 patients will be enrolled. According to the mode of presentation, the planned number of patients in the different study groups will be as follow : 70 patients with chronic liver failure and acute on chronic liver failure; 20 patients with acute liver failure ; 30 patients post-liver transplantation.

Eligibility Criteria:
Inclusion Criteria :

* All consecutive patients with a diagnosis of chronic liver failure, acute on chronic liver failure, acute liver failure, or post-liver transplantation ;
* Adult patient aged 18 years or above, and less than 85 ;
* Admission to the ICU for an expected period of \> 24 hours or elective admission for TIPSS placement ;
* Informed consent of the patient or nearest relative.

Exclusion Criteria :

* Age less than 18 years and more than 85 ;
* Pregnancy, including HELLP syndrome ;
* Active malignancy with metastases (localised hepatocellular carcinoma is not an exclusion criteria);
* Systemic chemotherapy in the last 4 weeks (trans-arterial chemo-embolisation for localised hepatocellular carcinoma is not an exclusion criteria) ;
* Acquired immunodeficiency syndrome and antiretroviral therapy ;
* Refusal of the patient or nearest relative.
Gene x Environment Interplay in Developmental Dyslexia Treatment: A Round-trip Translation Between Humans and Animal

Developmental dyslexia affects 7% of school-age children (Male:Female ratio of 1.5:1) and incurs disadvantages in education and occupation. Scientific progress concerning the etiology of developmental dyslexia evidenced the complex gene-environment interaction. The DCDC2-READ1 deletion associates with reading skills and affects the magnocellular-dorsal stream in humans and animals. DCDC2 modifies neural activity within the excitatory pathways. The magnocellular-dorsal stream mediates the function of the attention network. Difficulties in spatial and temporal attention shifting impair letter-to-speech sound integration increasing neural noise. Action video games improve the efficiency of the magnocellular-dorsal stream. The aim of this cutting-edge, round trip translation study is threefold: 1.to unravel new insights behind the pathophysiology of developmental dyslexia, 2. to assess gene-environment interaction effects on developmental dyslexia endophenotypes, and 3. to identify useful clues to foster the identification of new, personalized treatments.


Eligibility Criteria:
Inclusion Criteria

* 5-years old pre-readers,
* normal intelligence quotient,
* no main counter indications for magnetic resonance acquisition,
* no previous diagnosis of any neurodevelopmental disorders.

Exclusion Criteria:

* intelligence quotient below the average range,
* presence of counter indications for magnetic resonance acquisition,
* previous diagnosis of any neurodevelopmental disorders.
Sepsis: From Syndrome to Personalized Care

This is a prospective, observational study designed to examine the performance of biomarkers, molecular biological methods and other analysis in blood from patient with suspected sepsis in the Emergency department, as well as identidying novel sepsis endotypes. Around 1500 patients will be enrolled.

The study will prospectively include adult patients (\>18 years) with suspected sepsis admitted to Oslo University Hospital, Ullevål (OUH-Ullevål). Patients admitted to the emergency department and managed by the medical rapid response team or the sepsis rapid response team are considered eligible for inclusion. Informed consent will be collected at the emergency department if possible, or within few days, by a clinical investigator or a study nurse. The investigators aim to include 1500 patients treated by the Sepsis Rapid Response Team or Medical Emergency team for possible sepsis. Patients classified to have had other conditions than sepsis in the post hoc assessment will be used as controls. The inclusion period will be 3 years.

Eligibility Criteria:
Inclusion Criteria:

* admitted to emergency department OUH, Ullevål.
* managed by the medical rapid response team or the sepsis rapid response team

Exclusion Criteria:

* Not given informed consent by patient or next of kin (if patient is not able to)
Apioc Presbyopic Contact Lens

In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way you wear your current contact lenses for approximately one month (no more than 35 days).

Apioc-P and Apioc-PT is an investigational contact lens, which means it has not been approved by the U.S. Food and Drug Administration (FDA), although the contact lens material, called Definitive 74, is already approved and marketed for contact lenses that are similar to Apioc-P and Apioc-PT. In this study, participants will wear an Apioc-P and Apioc-PT contact lens the way they wear their current contact lenses for approximately one month (no more than 35 days).

Participation in this study will include a minimum of four study visits. The first will last up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45 minutes, and the final visit will be up to 90 minutes. If the lens does not appear to be fitting properly at the second visit, then another lens will be ordered for participants and they will be asked to return for an additional visit for up to 45 minutes. Up to 60 subjects will participate in this study.

Eligibility Criteria:
Inclusion Criteria:

1. The subject must provide written informed consent.
2. The subject must appear willing and able to adhere to the instructions set forth in this protocol.
3. At least 40 years of age and no more than 70 years of age.
4. ≤ 4.00 D of corneal astigmatism.
5. ≤ 4.00 D of refractive astigmatism.
6. Refractive error range +20.00 DS to -20.00 DS
7. Keratometry readings within 40 to 50D.
8. Clear, healthy corneas with no irregular astigmatism.
9. Normal, healthy conjunctiva in both eyes.
10. Free of active ocular disease. Refractive error and presbyopia are permitted.
11. Be a current or former (within the last 12 months) contact lens wearer.
12. Best-corrected near and distance visual acuity better than or equal to 20/25.

Exclusion Criteria:

1. Irregular corneal astigmatism.
2. Corneal scarring unless off line-of-site and well healed.
3. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
4. Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 times per week is permitted.
5. Systemic disease that would interfere with contact lens wear.
6. Currently pregnant or lactating (by self-report).
7. History of strabismus or eye movement disorder, including exophoria at near that is 4D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.
8. Active allergies that may inhibit contact lens wear.
9. Upper eyelid margin at or above the superior limbus.
10. History of ocular or lid surgery.
Investigating the Effectiveness of Eylea in Patients With Wet Age-related Macular Degeneration

The study aims to investigate the effectiveness of Eylea in patients with wet age-related macular degeneration in routine clinical practice in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.


Eligibility Criteria:
Inclusion Criteria:

* Patients with wet wAMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
* Written informed consent.

Exclusion Criteria:

* Exclusion criteria as listed in the local SPC.
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
* Any concomitant therapy with another agent to treat wet AMD in the study eye.
Implications for Treatment of the Metabolic Syndrome

To characterize features of metabolic syndrome in volunteers. To undertake a randomised trial to determine whether treatment with a statin improves muscle microvascular blood flow.

To characterise features of the metabolic syndrome, including body fat, insulin sensitivity, and liver fat together with muscle micorvascular blood flow.

To undertake a randomised controlled trial of atorvastatin 40 mg. o.d for 6 months to determine whether any of the above measures change with treatment.

Eligibility Criteria:
Inclusion criteria Body mass index (BMI) 20-35 kg/m\^2" and "\> 3 criteria for the metabolic syndrome (NCEP III ATP criteria - see below) , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides \>2.0 mmol/L - a cardinal lipid abnormality of the syndrome

NCEP III ATP metabolic syndrome criteria are:

Waist greater than or equal to 102 cm BP greater than 130 / 85 mmHg TG greater than or equal to 1.7mmol/l Glucose greater than or equal to 6.1 mmol/l HDL less than 1.0 mmol/l

Exclusion Criteria:

Aged \<18 years Aged \>75 years Known diabetes; renal, liver, or uncontrolled thyroid disease; uncontrolled hypertension; treatment with lipid-modifying drugs; antihypertensive medication; corticosteroid therapy; or hormone replacement therapy.
Effects of NT-0796 in Obese Participants at Risk of Cardiovascular Disease

This trial is a Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease.

Participants will be admitted to an in-patient Clinical Research Unit on Day -1 and will be discharged on Day 30. The trial will include a 7-day out-patient safety follow-up period following the last dose of study treatment.

For the first approximately 20 participants effect of food will be evaluated on the Pharmacokinetics of NT-0796. MRI's will be conducted in a subset of participants.

The goal of this clinical trial is to evaluate the effects of NT-0796 on inflammation in obese participants at risk of cardiovascular disease, evaluate the effects of NT-0796 on body weight and composition, to see how safe NT-0796 is, and how well it is tolerated and to measure the blood levels of NT-0796, with and without food.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 years or older.
2. Body mass index (BMI) ≥30 and ≤40 kg/m2 at screening.
3. Presence of 1 or more of the following risk factors for atherosclerotic cardiovascular disease:

   * History of controlled hypertension
   * History of hypercholesterolemia
   * History of high-density lipoprotein levels
   * Controlled Type 1 or Type 2 Diabetes mellitus

Exclusion Criteria:

1. History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months
2. History of acute coronary syndrome (ACS)
3. Stable angina.
4. Diagnosis of congestive heart failure
5. Evidence of past or current infection with Hepatitis B or Hepatitis C
A Trial to Evaluate the Efficacy and Safety of Two Concentrations of VBP-926 Solution for the Treatment of Chemotherapy-associated Paronychia in Cancer Patients

Paronychia is inflammation of the skin surrounding the nail that leads to secondary infection. Iatrogenic paronychia has been clearly associated with cancer chemotherapies. This phase-2 trial is a dose finding study and will evaluate topical VBP-926 solution against a vehicle control.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 years or older
* Acute paronychia developing during the course of their monotherapy or combination chemotherapy
* Involvement of at least one nail with a Paronychia Severity Grading score of 1 or higher
* Eastern Cooperative Oncology Group score ≤ 2
* Life expectancy of at least 12 months as per the investigator's judgment
* Willing to provide written informed consent
* Individuals who are willing to not start any new products OTC or prescription treatments for Paronychia and discontinue any treatment the investigator feels may interfere with the evaluation of the test products
* Individuals who are already on antibiotics as prescribed by oncologist for any condition except paronychia
* Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s)

Exclusion Criteria:

* Mentally incompetent or unable or not willing to give written informed consent or meet study requirements
* Without a history of a cancer diagnosis
* Without history of cancer diagnosis using chemotherapy
* Patients with paronychia requiring surgical intervention at baseline
* Patients who are already on prescribed treatment for paronychia who are not willing to discontinue this treatment and only use study drug (no washout period required)
* Neutropenia (absolute neutrophil count \< 1500 cells/µL)
* Patient Human Immunodeficiency Virus (HIV) infection
* Patients with any medical condition, including alcohol or drug abuse or mental incapacity / hypersensitive to the study drug, which in judgment of the investigator will interfere with the patient's participation in the study or evaluation of study results
* Have any medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk
Impact of Medical Nutrition Therapy and Follow-Up Frequency on Metabolic Syndrome Parameters

There is no study that has investigated the effects of medical nutrition therapy and more frequent follow-up via telehealth on metabolic syndrome parameters in patients with MetS who have multiple metabolic disorders such as being overweight, prediabetic/diabetic, dyslipidemic and having increased blood pressure. This study was conducted to examine the effects of medical nutrition therapy and increased follow-up via telephone calls on MetS-related parameters in individuals with MetS.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with HbA1c values \<8.5%
* Diagnosed with MetS by a physician according to the criteria declared by the consensus of the "International Diabetes Federation Task Force on Epidemiology and Prevention, National Heart, Lung, and Blood Institute, American Heart Association, World Heart Federation, International Atherosclerosis Society, and International Association for the Study of Obesity" were included.

Exclusion Criteria:

* Taking anti diabetic agents other then metformin
* Taking anti hyperlipidemic agents
* Taking anti hypertensive agents
* Using food supplements (w-3, chromium, multivitamins) that could affect metabolic parameters,
* Having kidney failure,
* Having liver failure,
* Having immune failure
* Having chronic gastrointestinal system disease
* Having cancer
* Having type 1 diabetes
* Being pregnant or breastfeeding.
Intra-articular Magnesium Sulfate for Tmj Dysfunction

mixing the magnesium sulfate with dextrose for management of tmj pain will be studied using intra-articular injection of the solution


Eligibility Criteria:
Inclusion Criteria:

* healthy females-no treatment received within the last 6 months-accept treatment protocol

Exclusion Criteria:

* unco-operative patients-patients with auto-immune diseases-patients diagnosed with arthritis