cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects

In this study the efficacy of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. The investigators expect this treatment to provide better outcome regarding scar quality.

Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Patients with with full thickness skin defects will be included in this study. This phase II study aims to investigate the efficacy of the use of this dermal matrix, with regard to scar quality as determined for elasticity at 3 months after treatment. Moreover, graft take (5-7 days after treatment), epithelialisation (5-7 days and 2-3 weeks), and scar quality (3 and 12 months after treatment, as determined for elasticity, colour/pigmentation, and using a subjective scar assessment scale) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years (for Zurich: ≤ 18 years)
* Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm
* ≤ 50% TBSA full thickness skin defects at time of intervention
* Informed consent by the patient and/or legal representatives.

Exclusion Criteria:

* Patients with infected wounds
* Full thickness skin wounds located in face and/or genitals will not be included
* Pregnant or breast feeding females
* Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer)
* Known allergy against porcine collagen or elastin
* Patients that are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
* Previous enrolment of the patient into the current study
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients

The goal of this clinical research study is to learn if ustekinumab can help to control immune-related diarrhea and/or colitis in cancer patients.

Primary Objectives:

To assess the efficacy of ustekinumab for clinical remission/response of immune-related diarrhea and/or colitis

To assess the efficacy of ustekinumab in reducing fecal calprotectin levels

Secondary Objectives:

To assess steroid free IMDC remission by week 4 and 8

To assess the IMDC recurrence by week 4 and 8

To assess the time duration to IMDC recurrence and overall survival

To assess the efficacy of ustekinumab to achieve endoscopic remission of immune-related diarrhea and/or colitis

To identify immune signatures related to GI irAEs and those specific to responsiveness to ustekinumab

To identify pro-inflammatory immune signatures in serum

To assess patient symptom and QOL

Eligibility Criteria:
Inclusion Criteria:

1. Patients who receive any type of ICI therapy
2. Patients with ≥ grade 2 immune-related diarrhea and/or colitis according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 45 days prior to enrollment in study
3. Patients with ability to understand and willingness to sign informed consent
4. Patients with a diagnosis of any type of solid tumors on ICI systemic therapy
5. No concern for active concomitant GI infection for immune-related diarrhea and/or colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation
6. Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment
7. Concurrent or prior cancer therapy (non-checkpoint inhibitors) that are not deemed as a significant contributor of the GI adverse event can be allowed in the study.

Exclusion Criteria:

1. Patients younger than 18 years of age
2. Patients with persistent gastrointestinal infection confirmed with positive testing despite completing 5 days of antibiotics
3. Patients on concurrent immunosuppressive therapies other than what will be given for colitis
4. Patients with history of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation
5. Pregnant and breastfeeding women
6. Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to enrollment in study
7. Patients who develop concurrent non-GI toxicity at the time of study treatment initiation
8. Patients have already received other biologic treatment for IMDC such as infliximab, vedolizumab
Performance of Whole Body MRI in Extraplevic Disease Detection in Patients Undergoing Pelvic Exenteration for Gynecological Maligniancies

The aim of this prospective observational diagnostic study is to investigate the diagnostic accuracy od extrapelvic disease detection using Whole-body-MRI (WB-MRI) in patients with gynecologic cancer candidate to the pelvic exenteration.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Written Informed Consent
* All patients with recurrent gynecological cancer that are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and palliative intent
* Patients considered fit for srugery

Exclusion Criteria:

* Controindication to MRI (Claustrophobia, implanted ferromagnetic materials or foreign objects, Known intolerance or controindication to the MRI contrast agent, cardiac pacemaker)
* Individuals who are not able or willing to tolerate the required prologed stationary supine position during examination (approximately 40-60 minutes)
* Patient unable to give informed consent
COmparison of PENG Block and SIFICB in Hip Fracture Surgeries

The aim of this study is to compare the effectiveness of the PENG block and SIFIB in facilitating the positioning for neuroaxial anesthesia and their impact on the quality of postoperative analgesia.

Hip fractures are a significant health problem that leads to severe morbidity and mortality in elderly individuals. Neuroaxial anesthesia is often preferred in the surgical treatment of these patients due to its ability to maintain hemodynamic stability and manage postoperative analgesia. However, the severe pain accompanying these fractures makes it difficult to achieve an appropriate position for neuroaxial anesthesia, which complicates both patient comfort and the work of the anesthesia provider.

In recent years, peripheral nerve blocks have emerged as an effective method to overcome this challenge. The pericapsular nerve group (PENG) block and supra-inguinal fascia iliaca compartment block (SIFIB) are commonly used techniques for the management of pain related to hip fractures. While studies comparing the analgesic efficacy of these two blocks exist in the literature, data regarding their specific effects on neuroaxial anesthesia positioning are limited.

In this study, patients scheduled for surgery due to hip fractures will receive either a pericapsular nerve group (PENG) block or a supra-inguinal fascia iliaca compartment block (SIFIB). Both block procedures will be performed under ultrasound guidance and sterile conditions, following standard protocols. After the block procedure, the time taken for patients to transition into the neuroaxial anesthesia position (primary outcome) will be measured, and the level of pain experienced during positioning will be assessed using the Visual Analog Scale (VAS).

In the postoperative period, VAS scores and additional analgesic requirements (secondary outcomes) will be recorded for 24 hours. Demographic data (age, gender, body mass index) and comorbidities will also be collected and used for intergroup comparisons. Throughout the study, patient privacy will be respected, and the collected data will be analyzed anonymously.

The study will be conducted in accordance with the Declaration of Helsinki, and informed consent will be obtained from all participants.

Eligibility Criteria:
Inclusion Criteria:

* Hip fractures
* 40-80 years

Exclusion Criteria:

* Contraindicated to spinal anesthesia
* allergy to local anesthetics
* severe peripheral neuropathy
* mental disorders
Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.

The Quickclot dressing contains Kaolin, a natural mineral that promotes the body's clotting process. This dressing will be applied for one minute to the area where the tonsils/adenoids were. The investigators are hoping to develop a standard of practice where Quickclot is a key addition for tonsillectomy surgery.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of adenotonsillar hypertrophy causing obstructive sleep disorders

Exclusion Criteria:

* Patients with signs or symptoms of obstructed breathing
* recurrent pharyngitis
* history of bleeding disorder
* history of prior adenotonsillectomy
Efficacy and Safety of Tolvaptan in Japanese Patients With Acute Heart Failure

The aims of the present study are to investigate prospectively the clinical course and outcome of the hospitalized heart failure patients treated with tolvaptan for management of fluid retention and serum sodium levels of less than 140 mEq/L and also to analyze the factors related with the efficacy including outcome of tolvaptan therapy.

Vasopressin mediates fluid retention in heart failure. Tolvaptan, an oral, nonpeptide, selective vasopressin V2-receptor antagonist, shows promise for management of heart failure.

Eligibility Criteria:
Inclusion Criteria:

1. hospitalized patients for decompensated heart failure with signs of fluid retention despite using diuretics other than tolvaptan and planned tolvaptan use
2. serum Na \< 140 mEq/L
3. age: \> or = 20 years at the time of informed consent
4. provided written informed consent.

Exclusion Criteria:

1. hemodynamic instability
2. patients with hypersensitivity to tolvaptan or similar compounds
3. anuric patients
4. patients who cannot feel thirst and are difficult to intake the fluid
5. patients who are pregnant, potentially pregnant or willing to be pregnant
6. patients have taken tolvaptan before enrollment after hospitalization
7. acute coronary syndrome
8. adrenal insufficiency
9. patients scheduled to undergo coronary angioplasty within the study period
10. ineligible patients according to the investigator's judgment
ICT-enabled Social-emotional Learning: Development of Responsibility and Well-being in the Educational Environment

The purpose of the study is to develop adolescents' social-emotional abilities to foster their personal and social responsibility, as well as their well-being, by means of a school-based intervention that addresses students, teachers and parents who participate in a social-emotional program using a technological platform. The program consists of activities based on solid theoretical frameworks on emotional intelligence, development of responsibility and meaningful learning.

EmoTIC is an emotional education program focused on the development of social-emotional competences through an application that can be used in mobile devices and tablets.The program is based on a space adventure, and provides reinforcement through score points and more time for the additional games. The duration of the program is 8 weeks.

The emoTIC 8 version is designed so that teachers can easily carry it out in their classrooms. The application consists of application-guided activities that are put into practice in class, and includes other exercises that are meant to be carried out at home. The activities that are designed to be carried out during school hours are named "missions", and the exercises the students will do at home are called "trainings". Both are essential to adequately conduct the intervention.

The emoTIC SPACE version is designed so that it is carried out autonomously at home, through application-guided activities. This version includes 8 activities for each of the 4 areas.

Eligibility Criteria:
Inclusion Criteria:

* To have signed the informed consent (or their legal tutors).
* Being between 11 and 18 years old.

Exclusion Criteria:

* Inability to understand the activities or the language used.
A Study to Assess Efficacy and Safety of Wangbi Capsule in Patients With Rheumatoid Arthritis

The aim of this multi-center, prospective, non-interventional cohort study is to evaluate the efficacy and safety of Wangbi capsule for rheumatoid arthritis patients in the real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of RA as defined by the ACR/EULAR 2010 classification criteria
* Patients older than 18
* Syndrome of insufficiency of liver and kidney or syndrome of cold and dampness defined by traditional Chinese medicine

Exclusion Criteria:

* Patients who are pregnant or breast feeding at enrolment
* History of malignancy prior to screening
* Patients with severe or poorly controlled chronic diseases such as hypertension, diabetes and coronary heart disease
* Patients taking biological agents, \> 10mg prednisone (or equivalent amount of other glucocorticoids) ，more than 2 kinds of DMARDs or similar TCM drug like Wangbi Capsule
Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients

10 patients with chronic heart failure receiving daptomycin therapy after implantation of a left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids (mediastinal and pleural drainage systems) and in blood samples.


Eligibility Criteria:
Inclusion Criteria:

* written consent
* heart assist device implantation
* wound drainage
* daptomycin therapy

Exclusion Criteria:

* pregnancy
* no written consent possible
* absence of wound drainage
* allergy to study medication
* acute rhabdomyolysis
Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma

Glaucoma is the second leading cause of blindness among seniors in Canada. It is often associated with an elevated intraocular pressure (IOP), but its exact mechanism is still largely unknown. Some studies have shown a link between glaucoma and changes in the amount of oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular veins among three different groups using a spectrophotometer. This instrument is linked to a camera and can measure the quantity of oxygen in the veins using different characteristics of the blood inside.

The groups of the study are: patients without glaucoma, patients suspected of glaucoma and patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost 0.004%, will only be administered to the groups suspected or diagnosed with glaucoma. Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten patients will be recruited into each group for a total of 30 patients in this study. All patients for the suspected or diagnosed groups will be recruited from the Jewish General Hospital. Subsequently all testing will be done at the École d'optométrie, Université de Montréal


Eligibility Criteria:
Inclusion Criteria:

* good systemic health
* irido-corneal angle open
* intraocular pressure more than 18 mmHg

Exclusion Criteria:

* having cardiovascular problem
* Hypertension or diabetes
* under systemic medication for high blood pressure
* had an ocular surgery in the past
Renal Parenchymal Core Needle Biopsy

Percutaneous image-guided parenchymal renal biopsy has been used to detect the different pathologies of renal parenchyma, to define the degree of reversible changes, and to define when the medical treatment fails. Percutaneous core needle renal biopsy has been reported to have a higher diagnostic yield compared to fine needle aspiration. Percutaneous core needle renal biopsy is usually based on tissue sampling under guidance of either sonography or computed tomography. Renal parenchymal biopsy can be done either with a coaxial or noncoaxial technique. In coaxial technique, the introducing needle is placed in the renal parenchyma; then, multiple tissue sampling can be performed throughout the same tract. Alternatively, in noncoaxial technique, biopsy needle is inserted repeatedly for each tissue sampling. Although there are some reports regarding the comparison of coaxial and noncoaxial methods of renal mass biopsy, comparison of the two methods in renal parenchymal biopsy has not yet been described in the literature. In this prospective study, the investigators sought to compare the procedural time and the complication rate of coaxial technique with those of noncoaxial technique in percutaneous renal parenchymal biopsy.


Eligibility Criteria:
Inclusion Criteria:

* impaired renal function
* proteinuria
* hematuria

Exclusion Criteria:

* renal hydronephrosis
* chronic renal failure
* a history of renal cell carcinoma
* suspicious renal mass
* uncorrectable coagulopathy
MP3 (Microperimeter 3) Reproducibility in Healthy Subjects and Macular Patients

The aim of the present study is to investigate the reproducibility of the MP3 and to compare the results with conventional perimetry using the Octopus 101 in healthy subjects and patients with macular disease.


Eligibility Criteria:
Inclusion criteria for healthy subjects

* Men and Women aged 18 and older
* Written informed consent
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant

Inclusion criteria for macular disease patients

* Men and Women aged 18 and older
* Written informed consent
* Presence of a macular disease (such as dry or exudative age-related macular degeneration, diabetic maculopathy, epiretinal membrane)

Any of the following will exclude a subject from the study:

* Any opacities (corneal scar, dense cataract) which interferes with the study relevant measurements
* Visual acuity \< 0.1 (Snellen)
Outpatient Management of Tonsillectomy in Adults

Tonsillectomy is a frequent surgical procedure in the ENT specialty but it can be a source of postoperative pain that can be important. These pains complicate the intake of food and in particular the intake of analgesic drugs per os and require the prolongation of the hospitalization in order to continue an intravenous analgesia. The aim is to set up a protocol for ambulatory care of adult tonsillectomies. Then, it would allow an improvement of the postoperative quality of life for the patient, who prefers a quicker return home.The study aims to allow patients to come back home early after tonsillectomies with intravenous analgesia. Pain, feeding and quality of life will be evaluated regularly through an application called MAELA during a few days after surgery. They will also be evaluated by nurses coming via providers.


Eligibility Criteria:
Inclusion Criteria:

* Indication for a tonsillectomy defined in the French recommendations
* Age between 18 and 60 yo
* Providing free and informed consent to participate
* Having a smartphone able to process MAELA application
* Affiliation to french social security
Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

Exclusion Criteria:

* Pregnancy or lactation.
* Positive titres for anti HBs antibody.
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL.
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Simultaneous administration of any other vaccine(s).
* Administration of any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial.
Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia:

The primary objective of the study is to prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, either transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset. The study was sized based on a mean pain reduction of 1.5 points on a numerical scale (0-10 NAS), with an estimate of procedure-related pain of 4.0 on the NAS scale.

Prospective comparison of pain during the procedure assessed in patients treated for prostate biopsies under local anesthesia with or without a virtual reality headset.No additional examination will be performed in addition to the conventional management of a biopsy except for the fitting of the headset for patients randomized to the "with virtual reality headset" group.

Patients will be randomized on the same day of the procedure into one of the two study groups.

A single follow-up visit will be performed postoperatively 1 month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route
* Patient having signed informed consent

Exclusion Criteria:

* Patient suffering from blindness or any other visual handicap that contraindicates the use of the headset
* Deaf or hard of hearing patients
* Patients suffering from epilepsy and/or mental deficiency, and/or disorders of higher functions
* Psychotic patients
* Claustrophobic patients or those who cannot tolerate a mask over their eyes
* Refusal of local anesthesia
* Protected person (art. L1121-5 to L1121-8 of the CSP)