cyrilzakka/clinical-trials huggingface dataset:
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

This study will be done to investigate perioperative lidocaine infusion on neutrophil extracellular trapping in the patients undergoing the robot-assisted prostatectomy.

Neutrophil extracellular trapping by analyzing the meyloperoxidase, neutrophil elastase, citrullinated histone3

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled robot-assisted prostatectomy

Exclusion Criteria:

* lidocaine allergy Hx
* hemodynamic unstable patients
* weight \< 40kg
* arrhythmia or bradycardia
Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy

Patients suffering from a proximal humerus fracture treated with plate osteosynthesis will receive either regular aftercare (physiotherapy) or aftercare assisted with continous passive motion (physiotherapy + CPM). Change in functional and patient-reported outcome (PROM) over time will be evaluated and compared.

The investigators will conduct a prospective, monocentric study focusing on the rehabilitation process after surgical treatment of proximal humerus fractures. Patients treated with plate osteosynthesis and eligible to participate will be randomly assigend to either a regular rehabilitation protocol (immobilization and physiotherapy) or a rehabilitation protocol with the additional use of a continous passive motion device (immobilization, physiotherapy and CPM).

After 6 and 12 weeks as well as 1 year in a follow-up examination functional (range of motion) and patient-reported outcome (Disabilities of Arm, Shoulder and Hand Score \[DASH\], Constant-Score, pain on visual analogue scale, subjective satisfaction) will be evaluated. Results will be compared towards possible differences and effect of CPM therapy. In addition demographic factors (age, sex, BMI, etc.) and complications will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* patients with proximal humeral fracture treated with plate osteosynthesis during the enrollment period
* understanding of German language (written and oral)
* written informed consent of the patient or the legal guardian

Exclusion Criteria:

* patients not meeting the aforementioned criteria
* patients with the need of / or an already existing endoprosthesis
* patients with ipsilateral fracture of the distal radius
* patients with cerebral damage (contusio or commotio cerebri)
* patients with affection of the brachial plexus or nerve palsy
* non-compliance
Telerehabilitation Following Ankle Fractures

Background and Purpose: Ankle fractures represent one of the most common fractures in North America. Surgical fixation is often required in the presence of dislocation or instability and has been shown to have a high rate of success. Following surgical fixation, physical therapy is commonly utilized to assist in regaining function. Advice alone has been shown to be non-inferior to traditional physical therapy for patients post-ankle fracture in two studies. The results of these studies have yet to be repeated in the US. It is the intent of this study to investigate the feasibility of a large clinical trial comparing the results of traditional physical therapy and an internet-based telerehabilitation program. Following surgical repair of ankle fractures, patients will be randomized to traditional rehabilitation or telerehabilitation. Telerehabilitation may represent an alternative patient option to traditional physical therapy following ankle fracture repair. The results of this study will inform the design of larger multi-site clinical trials investigating the effectiveness of telerehabilitation for this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Bimalleolar or trimalleolar fracture
* Repaired with open reduction internal fixation technique
* Must have access to computer, tablet, or smart phone with internet access

Exclusion Criteria:

* Severe soft tissue damage associated with injury
* Physical or mental conditions that will affect patient's ability to participate in independent rehabilitation
* Non-English speaking
Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa

This study is being conducted to evaluate if a written action plan for hidradenitis suppurativa (HS) will help patients with hidradenitis suppurativa gain a better understanding of the condition and how to manage the condition on a daily basis compared to a routine verbal consultation.


Eligibility Criteria:
Inclusion Criteria:

* This study will only enroll subjects between the ages of 18-years and 89-years of age.
* Diagnosis of HS by a board-certified dermatologist
* Able to read and comprehend study materials
* No prior exposure to written HS action plans

Exclusion Criteria:

* Those who do not fit the inclusion criteria
Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

Vaccination against SARS CoV-2 appears to be the best strategy today to control the COVID-19 pandemic. The first published studies with Pfizer, Moderna and Astra-Zeneca vaccines show very good vaccine protection in the general population and good short-term tolerance. The efficacy of these vaccines ranges from 62 to 95%, which is particularly remarkable, especially for mRNA vaccines. Nevertheless, these studies do not report the vaccine response in organ transplant patients.

It is known that transplant patients have lower vaccine responses than immunocompetent patients due to some degree of immunosuppression.

Therefore, the investigators are interested in evaluating the vaccine response of organ transplant recipients after vaccination against SARS- CoV-2. For non-responder patients, new strategies can be proposed: 3rd or 4th boost of vaccine or perfusion/injection of antiS monoclonal antibodies. These strategies must be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, adult or child (15 years and older)
* Patient vaccinated against SARS-CoV-2 as part of routine care, and having received the 2 injections
* Solid organ transplant recipient
* Transplantation for more than 3 months

Exclusion Criteria:

* History of anaphylactic shock or known allergy to PEG
* Known history of COVID or positive Covid serology in the 3 months preceding inclusion
* Formal contraindication to an intra-muscular injection
* Impossibility to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...)
* Subject under legal protection
* Subject under guardianship or curatorship
* Patient having expressed his opposition to participate
Clinical Accuracy and Reliability of Infrared Tympanic Thermometer in an Adult Emergency Department

The primary aim of this study was to determine the accuracy of an infrared thermometer compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to compare tympanic and axillary temperature measurements by evaluating agreement and correlation to determine whether an infrared tympanic thermometer can replace an axillary mercury thermometer in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Above 37.5°C measured by axillary mercury thermometer

Exclusion Criteria:

1. otitis external/media
2. soft-tissue infection over the axillary fossa and forehead
3. complete occlusion by earwax
4. severe illness
5. trauma
Defining the Best Approach to Block the Pain After Knee Surgery

The study aims to compare standard techniques used to control pain after knee surgery. The investigators hypothesize that the fascia iliaca block is faster, safer and as good as or better than the femoral block, with or without a stimulating catheter.

60 patients being treated for ACL repair or knee arthroplasties under regional anesthesia will be randomized to three groups: Fascia Iliaca Block (FIB), Femoral Block (FB) with stimulating catheter or FB without stimulating catheter. A catheter will be placed according to each technique, before the surgery. A bolus of local anesthetic will be given pre-surgery and at the end of the operation, in all groups. A continuous infusion will be started for 48 hours. All patients receive a standard analgesia cocktail and rescue medication.

Pain and level of activity, as well as side effects, will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients coming for ACL or knee prosthesis surgery
* Between 18-80 years old
* Consenting for spinal anesthesia

Exclusion Criteria:

* Major neurologic diseases
* Obesity with body mass index (BMI) \> 30
* Infection at the punction sites (back and/or groin)
* Diabetes mellitus for longer than 5 years
* Coagulopathy
Prospective Pediatric Vesicoureteral Reflux Surgery Database

The purpose of this research is to provide a clearer understanding of quality and outcomes for three types of surgical procedures performed at Connecticut Children's for treatment of vesicoureteral reflux. In order to consistently gather data over time, the investigators propose to establish database for surgical intervention for vesicoureteral reflux.

Specific Aim 1: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to increase internal understanding of these procedures.

Specific Aim2: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to perform more valuable clinical analysis for publication.


Eligibility Criteria:
Inclusion Criteria:

* Subject scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.

Exclusion Criteria:

* Subject not scheduled to receive surgical intervention for the treatment of vesicoureteral reflux at Connecticut Children's.
Sputum Purulence as a Predictor of Cystic Fibrosis Exacerbations: a Prospective Cohort Trial.

To use the sputum colour chart as a predictor for cystic fibrosis exaerbations

Patients will score their sputum purulence daily using three colour charts. They will also score for respiratory and other symptoms.

Primary analysis will focus on the predicting value of sputum purulence on exacerbations. Secondary analysis will evaluate symptoms on exacerbation prediction. A third subanalysis will focus on correlation of daily pollution fluctuations and sputum purulence or symptoms.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of cystic fibrosis
* Pseudomonas aeruginosa colonization
* at least 2 exacerbations in the previous year
* at least 18 years of age

Exclusion Criteria:

* colour blindness
Pharmacokinetic of Tacrolimus in Paediatric Liver Transplant Patients

Tacrolimus is the cornerstone immunosuppressant in children with liver transplantation, its use is complicated by its narrow therapeutic index and variable pharmacokinetics. This study is designed to assess the posology of tacrolimus in post-transplantation in the month after liver transplantation to obtain a therapeutic target between 10-15 ng/mL and the impact of biological and genetic factors on the pharmacokinetic parameters in paediatric liver transplant recipients.

Tacrolimus is the cornerstone immunosuppressant in children with liver transplantation, its use is complicated by its narrow therapeutic index and variable pharmacokinetics. Therapeutic drug monitoring (TDM) of tacrolimus, based on whole-blood trough concentration (C0) values, is mandatory for use of twice-daily tacrolimus (Prograf_) as in order to decrease interindividual variability in exposure and thereby minimize the risk of acute rejection and the occurrence of adverse effects (mainly nephrotoxicity and, to a lesser extent, neurotoxicity).

Until now, the C0 is the easiest means of individual dose adjustment, as only one blood sample is required and the clinician can easily calculate the dose needed to reach the target. Many factors have an impact on the pharmacokinetic parameters. However the adaptation of the time to achieve the target stays an issue. Among factors of inter and intra variability of pharmacokinetic of tacrolimus, some of them are specific of the pediatric liver transplantation population.

Aims: To build a population pharmacokinetic model that describes the apparent clearance of tacrolimus and the potential demographic, clinical and genetically controlled factors that could lead to inter-patient pharmacokinetic variability within children following liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Age of children who need to have a liver transplantation : between 6 month and 12 years
* Formulary of consent signed by the two parents.
* Children who need to receive tacrolimus per os (Modigraf® ) only after liver transplantation associated to Simulect® (basilixumab) in post-transplantation immediately as main
* Affiliation to the system of social protection.

Exclusion Criteria:

* Children who need a multi organs transplantation
* Hypersensibility or Contraindication to Modigraf® or others macrolides.
* Patients retransplanted in the 14 days after the transplantation
* Patients with multivisceral failure
* Patients who have an introduction of tacrolimus 3 days after transplantation
* Patients who need complementary immunosuppressive drugs with corticoids excepted methylprednisolone used for reject
* Patients who received Prograf® per os or iv.
* Patients who received Cellcept® or Myfortic®
* Opposition to sign the formulary of consent or the understand the note of information
Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

The trial is aimed to investigate an orthodontic treatment with a new removable-part-time-wearing appliance, based on "High-Tech" technology.

The appliance should be wear only 12-14 hours a day, and is made of a single silicone aligner, made specifically for the patient, using 3-D screening technology of the patient's malocclusion. The aligner has a designed pathway "built-in" for the tooth to move, from the original position of the malocclusion to the "end point" - the correct position.

The force system, that is needed in order to generate tooth movement, is produced by tiny air-balloons which are incorporated in the aligner.

The study hypothesis is, that an orthodontic treatment can be done successfully with this part-time wearing appliance.

The appliance include:

* silicone aligner (made specifically for the patient.
* simple air pump to blow air in the tiny balloons.

The patient is guided to wear the appliance 12-14 hours a day, after filling air in the balloons, under the doctor's instructions.

Clinical examination for follow-up will be done every 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate class I malocclusion
* good general health
* good oral hygiene

Exclusion Criteria:

* bad cooperation
* any mental or health problem
* severe class I malocclusion, class II or class III malocclusion
Does the Use of Patient Specific Instrumentation Improve Outcomes in Knee Arthroplasty Surgery for Osteoarthritis When Compared to Standard Posterior Referenced Instrumentation?

The goal of this randomized study is to see if using patient-specific instruments (PSI) during total knee replacement surgery improves outcomes compared to standard instruments. The study focuses on adults with knee osteoarthritis who need knee replacement surgery. Specifically, it aims to answer the following questions:

Does using PSI improve knee function and stability as experienced by the patient? Does PSI lead to more normal knee motion during bending and straightening? Does PSI result in at least as good tibial (shin bone) component fixation as standard instruments? Is PSI more cost-effective than standard instruments? Researchers will compare PSI with standard instruments in 70 patients. Half will receive knee replacement surgery using PSI, and the other half with standard instruments. Patients will be randomly assigned to each group.

Participants will:

Undergo knee replacement surgery with either PSI or standard instruments. Have a series of follow-ups, including assessments of knee function, satisfaction, and alignment of the knee implant, conducted before surgery and at 3 months, 1 year, 2 years, and 5 years after surgery.

The study will include patients aged 40-75 with primary osteoarthritis, a body mass index (BMI) below 35, and no other major medical conditions that could impact surgery. Patients will also need to be willing to undergo necessary imaging, such as magnetic resonance imageing (MRI) scans and standing X-rays.

Outcomes will be measured using various assessment tools, including the Oxford Knee Score, Knee Society Score, and a patient satisfaction survey. Researchers will also record surgery details, such as operating time, blood loss, and knee implant size. Imaging methods, including MRI, computed tomgraphy (CT) scans, and specialized X-rays, will be used to evaluate knee alignment and stability over time.

The results of this study are expected to provide insights into whether patient-specific instruments offer clinical or economic advantages over traditional tools in knee replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Medial or lateral primary osteoarthritis (OA) Ahlbäck Grade 2-4
* Varus or valgus deformity ≤10 degrees, extension defect ≤10 degrees
* Age 40-75 years
* BMI \<35
* American Society of Anesthesiologists (ASA) score 1-3.
* Coming from independent living in own home
* Able and willing to undergo MRI scan (for custom patients), full-leg standing radiographs and follow up with RSA
* Written informed consent.

Exclusion Criteria:

* Cortisone treatment during the last 6 months before operation
* Neurological diseases with symptoms, stroke with sequel
* Endocrine diseases with symptoms
* OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities
* BMI \>=35
* OA of the hip with symptoms
* Ongoing infection
* Any metal within 150 mm from the joint line on the side to become operated
* Unable or unwilling to participate in the follow-up.
Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection

The diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures such as biopsy or excision in order to analyze the structure and appearance of the fabric pathologists. With recent advances in optical and electronic fields, considerable efforts were produced to build high-performance optical instruments, able to transcribe the internal structure of the skin with varying degrees of depth and variable resolution.

The imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and in real time. This area is booming and new optical instruments are created to eventually be able to offer a reliable alternative to invasive techniques.

The optical properties of different tissues have been studied for several years by different research groups: the coefficient of light absorption by the tissue both in vivo and in vitro, the coefficient of light scattering or the index refractive were characterized in various tissues that make up the skin.

Other studies have focused on melanoma detection by multispectral optical techniques, or via the technique of optical coherence tomography (OCT) performed on lesions suspicious for cancer, but without linking criteria between these two techniques.

However, no study to date and to our knowledge has been able to demonstrate the different optical parameters obtained with OCT and can be directly connected to known and histopathological parameters commonly used in the diagnosis of lesions skin. This study aims to verify if it is possible to determine the parameters measured in OCT that would discriminate between benign and malignant lesions.


Eligibility Criteria:
Inclusion Criteria:

* patients with suspicious skin lesions of malignant tumor (mostly non-melanoma: basal cell carcinoma, epidermoid carcinoma and actinic keratoses, or melanoma: melanoma, nevi) requiring biopsy / surgical excision;
* consent signed

Exclusion Criteria:

* Any dermatosis, hyperalgesic lesion, and / or infected and / or topography making it impossible measurements;
* pregnant and nursing women
* patients under tutorship or curatorship
Cardiovascular Disease Risk of Awareness

The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce risk factors.

While 1/3 of premature deaths in individuals under the age of 70 in the world occur due to Cardiovascular Diseases (WHO 2022), circulatory system diseases are at the forefront with 36.76% according to the health statistics of the Ministry of Health in our country. It is necessary to raise awareness and gain healthy lifestyle behaviors in the prevention of cardiovascular diseases. The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Not having been diagnosed with cardiovascular disease.
* Using a smartphone.
* Agree to use the Google Fit App.

Exclusion Criteria:
Hormones and Reduction in Co-users of Marijuana and Nicotine

The purpose of this study is to examine the role of progesterone (a naturally occurring hormone found in both men and women) on reducing marijuana use. The investigators will see if progesterone effects impulsivity, withdrawal, mood and stress during marijuana cessation.

This double-blind, randomized pilot clinical trial will prescreen an estimated 250 potential subjects, consent and further evaluate approximately 100 potential subjects, and ultimately enroll 70 subjects to ensure 40 subjects will provide a primary marijuana reduction outcome measure at four weeks post quit date. Subjects will be stratified by sex then randomized to one of two treatment groups (n=20 per drug group, 50% female): progesterone (PRO; 200mg 2x/day) or Placebo (PBO). Telephone screening and visit invitation (20 minutes) leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion (two visits, two hours each), then randomization and medication start (7 days), then stable medication (28 days) with medication reduction and final evaluation (7 days).

Eligibility Criteria:
Inclusion Criteria:

* Males 18-60 years old, females 18-50 years old
* Stable physical and mental health
* Self-report Timeline Follow-Back (TLFB) indicating current marijuana use ≥4 days/week for ≥1 year
* Positive urine THC dipstick test (\> 50ng/mL; indicating marijuana use in the past 48-72 hours)
* Motivated to change their marijuana use (\>1 on a 10-point Likert-type scale) -Regular or sporadic use of nicotine cigarettes (\> 1 cigarettes in the past 30 days) -Self-report of regular menstrual cycles \>6 months (female only)
* Willing to use double-barrier contraception if sexually active and not surgically sterilized (female only)
* Ability to comply with study procedures, ability to provide informed consent.

Exclusion Criteria:

* Current breastfeeding (females only),
* Current or planned pregnancy within the next three months (females only)
* DSM-IV diagnoses for psychotic disorders, bipolar disorder, ADHD, major depressive disorder within the last 3 months
* Substance dependence within the last 3 months with the exception of nicotine and marijuana dependence
* Unstable psychotropic medications (\<3 months)
* Current use of exogenous hormones, finasteroid (propecia), efavirenz, red clover, ketoconazole and other drugs that are CYP3A4 inhibitors
* Conditions contraindicated to progesterone treatment (including, but not limited to, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke, allergy to peanuts, hypersensitive to progesterone and liver dysfunction)