cyrilzakka/clinical-trials huggingface dataset:
Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing

The purpose of the study is to evaluate the use of the SPY Elite System to assess real-time tissue perfusion of lower extremity amputation sites and to develop parameters to predict healing of amputations at the time of surgery.

This is a pilot study to see if the Spy Elite System is capable of recording accurate measurements on amputation sites to allow some correlation to healing. If this study shows promise for the device, the investigators would plan a larger study in which the data would be assessed in the operating room at time of acquisition and revision performed if needed based on the findings.

The pilot study is a prospective cohort study of consented subjects who require below knee or above knee amputation. The study will start with 18 subjects to assess proof of concept. If a correlation is identified, then a new proposal will be submitted with a larger cohort.

Our hypothesis is that the Spy Elite System can help identify areas of poor tissue perfusion at the time of lower extremity amputation, and predict future potential wound healing complications.

Primary outcome variables include wound healing at 30 days, and intra-operative imaging of amputation sites using the Spy Elite System. Secondary outcome variables include level of amputation, 30-day wound healing complications, readmission rate, need for revision, and subject demographics and co-morbidities.

Subjects who agree to participation will undergo the amputations in the operating suite as per routine. The Spy Elite System will be implemented after final wound closure and prior to dressing placement. A single injection of 10 mg of Indocyanine Green will be administered, followed by 10 ml bolus of normal saline as per manufacturer IFU and recommendations (Attachments B, C, D). Recording from the Spy Elite Device will be saved for analysis. Also, a digital photograph of the surgical wound will be saved for comparison. No changes in operative management based on Spy Elite System will take place in this study.

At subjects routine 30-day follow up appointment, wounds will be assessed for complications, a digital photograph of the incision will be saved, and secondary endpoints will be obtained.

Possible correlations between perfusion values from the Spy Elite System recording and wound healing will be analyzed by the Investigators. The values will not be known until after the photos are taken and the investigators compare ischemic areas to normal areas based on the collected photographs.

Eligibility Criteria:
Inclusion Criteria:

* All patients \>= 18 years of age requiring Below Knee Amputation (BKA) or Above Knee Amputation (AKA) cared for by the vascular surgery service will be assessed for eligibility.

Exclusion Criteria:

* Subjects with a history of allergies to iodides or iodinated contrast agents, pregnant or nursing women, subjects who are unable to provide consent, and prisoners will be excluded.
Atrioventricular Block and Cluster Headache (SEVA)

Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. In France, its prescription in that indication is based on compliance with the Temporary Recommendation for Use (RTU) that insists on the possible the cardiac side effects that can occur as the doses required for cluster headache are significantly higher than the doses used in cardiology.


Eligibility Criteria:
Inclusion Criteria:

* patient 18 years old, and older
* patient suffering from Cluster Headache (according to the l'ICHD-3 diagnostic criterias)
* patients affiliated to the social security
* patient that has given his full written consent to participate in the study
* female patients participating in the study must be using an efficient contraception for more than 1 month prior to the beginning of the study

Exclusion Criteria:

* patient presenting contraindications to the use of verapamil
* patient observing a treatment with ivabradine (Procoralan®), bétablockers, colchicine, l'esmolol, triazolam, quinidine.
* patient under justicial protection
* patient breastfeeding, or pregnant
* patient suffering from a neuromuscular transmisson disease
* patient with a pacemaker
Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care

Peripheral venous catheterisation is a multi-daily practice in a paediatric ward.

In our pediatrics department, nurses have observed for several years now the appearance of pressure sore-like skin lesions at the junction of the peripheral venous catheter with the extension tube. A ward habit has spontaneously developed of applying a compress under this junction. The objective is to minimize physical or emotional aggression as well as pain. Pain that is denied or not identified and not relieved is memorized by the child, which can have consequences on the perception of pain and the subsequent acceptance of care.

To date, through their reading and research, investigators have been able to find articles mentioning the risks of pressure ulcers in children related to medical devices. However, few elements are developed concerning catheter-related pressure ulcers, especially on this specific technique for preventing injuries at the catheter-extension tube junction. Investigators have not found any recommendations on this subject.

Thus, the aim of this study is to compare two peripheral venous catheter fixation devices, with compress and without compress, and to analyse the frequency of pressure ulcer occurrence and the intensity of this lesion.


Eligibility Criteria:
Inclusion Criteria:

* Aged 1 month to 18 years old, according to the criteria of the paediatrics department of the Departmental Hospital la Roche sur Yon .
* Hospitalized in paediatrics ward or consultant in paediatric emergencies with a high probability of being hospitalized in paediatrics ward later.
* With an indication for the insertion of a short peripheral venous catheter
* Written agreement from the holder(s) of parental authority

Exclusion Criteria:

* Children with dermatological affections prior to inclusion and at the puncture site (atopic dermatitis, skin infection, skin wound, chickenpox, epidermolysis bullosa)
* Allergy to fixation devices
* Known immune deficient child
* Refusal of the patient or of the holders of parental authority to participate
* Life-saving emergency care
* Patient already included in the study
* Patient without social security coverage
Analysis of Spread Level During Thoracic Erector Spinae Block

The primary purpose of this study was to identify the ESPB spread level in the craniocaudal direction when performed at the T2 level. The secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with ESPB

The ESPB requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis muscles comprise the ES muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base. The ESPB can be performed in the cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more widely compared to cervical and lumbar regions. Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side. The exact mechanism of action of ESPB remains unclear. A recent study suggested that the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. However, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of ESPB.

Eligibility Criteria:
Inclusion Criteria:

* cervical facet joint arthrosis
* cervical foraminal stenosis
* cervical herniated intervertebral disc
* myofascial pain syndrome of upper back muscle

Exclusion Criteria:

* allergy to local anesthetics or contrast medium
* pregnancy
* prior history of cervical spine surgery
* coagulation abnormality
IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

Glaucoma is a group of diseases that damage the eye's optic nerve, result in progressive visual field defect and blindness. The aim of glaucoma management is to reduce IOP, and glaucoma implant surgery is the alternative treatment that can be chosen. The effectiveness of the implant on the end stage glaucoma patients was evaluated by the reduction of intra ocular pressure (IOP) and well formed blebs that were evaluated clinically and by using anterior scanning optical coherence tomography (AS-OCT). The safety of the implant was determined by the regression of the clinical symptoms and there were no severe complications such as implant extrusion. Two patients developed improvement of the visual acuity. This was an unpredictable positive result.

The study is to measure the efficacy of new GDD that made with polymethyl methacrylate. The primary outcome is IOP reduction. The secondary outcome is glaucoma medication post surgery and complication that occurred during the follow up. The subjects are refractory glaucoma patients that need glaucoma drainage device implantation. The measurement are collected on first day, first month, third month, sixth month and twelve month. The IOP will be measured using GAT (Goldmann applanation tonometer), but if the subjects are not cooperative, they will be measured using i-care. On the follow up, the glaucoma medication needed will be noted and also for the complication and the need for other surgery, e.g. AC formation using viscoelastic, repair tube/plate exposure, cyclo photocoagulation, etc.

Eligibility Criteria:
Inclusion Criteria:

* End stage glaucoma patients whose IOP is failed to be controlled by glaucoma medications
* Patients that are willing to participate in the study
* Patients with \<6/60 visual acuity
* Patients above 18 years

Exclusion Criteria:

* Patients with combination surgery indication (eg. glaucoma with cataracts)
* Eyes with congenital disease of anterior segment dysgenesis
* Eyes with uneven surface of the cornea that the measurement IOP with Goldmann tonometer could be difficult
* Eyes with broad conjungtival cicatrix that are impossible to be implanted
Controlled Exposures to Air Pollution in Patients With Coronary Heart Disease

Air pollution is a major cause of cardiovascular morbidity and mortality. The components of air pollution responsible and the mechanisms through which they might mediate these harmful effects remain only partially understood. We hypothesise that these adverse effects are mediated by combustion derived air pollutants and that even a brief exposure will effect heart and blood vessel function. We assess the effect of dilute diesel exhaust inhalation at levels encountered in urban road traffic on heart and blood vessel function in patients with stable coronary heart disease.

Observational studies suggest that exposure to air pollution may worsen symptoms of angina and trigger acute myocardial infarction. These findings are limited by imprecision in the measurement of pollution exposure, the effect of potential confounding environmental and social factors, and the lack of mechanistic data. Controlled exposures of air pollutants can help to address these shortcomings by providing a precisely defined exposure in a regulated environment that facilitates investigation with validated biomarkers and surrogate measures of cardiovascular health. Using a carefully characterised exposure system, we have previously shown in healthy volunteers that exposure to dilute diesel exhaust causes lung inflammation, depletion of airway antioxidant defences, and impairment of vascular and fibrinolytic function. To date, there have been no controlled exposures in patients with coronary heart disease: an important population who may be particularly susceptible to the adverse cardiovascular effects of air pollution.

In a double blind randomized cross-over study, 20 patients with prior myocardial infarction will be exposed to dilute diesel exhaust (300µg/m3) or filtered air during periods of rest and moderate exercise in a controlled exposure facility. During the exposure, myocardial ischemia will be quantified by ST-segment analysis using continuous 12-lead electrocardiography. Six hours following exposure, vascular vasomotor and fibrinolytic function will be assessed by means of intra-arterial agonist infusions.

Eligibility Criteria:
Inclusion Criteria:

* Previous myocardial infarction (\>6 months previously) treated by primary angioplasty and stenting
* On standard secondary preventative therapy

Exclusion Criteria:

* Angina pectoris (Canadian Cardiovascular Society grade ≥2)
* History of arrhythmia
* Diabetes mellitus
* Uncontrolled hypertension
* Renal or hepatic failure
* Unstable coronary disease (acute coronary syndrome or unstable symptoms within 3 months)
* Occupational exposure to air pollution
* Current smokers
* Asthma
* Inter-current illness
Anemia and Duration of Mechanical Ventilation

In mechanically ventilated patients in intensive care unit, anemia is commonly seen and it is probably associated with adverse outcomes including mortality. We aim to investigate the impact of duration of anemia and the duration of mechanical ventilation as well as clinical outcomes in critically ill patients in intensive care unit who required ventilatory support \>96 hr.

Anemia is one of the most common conditions encountered critically ill patients. Various mechanisms can put these patients at risk of anemia including gastrointestinal hemorrhage, iron deficiency, inflammation and infection, stress, and multiple blood testing. Anemia can affect cardiopulmonary function as depletion in oxygen content in body. In mechanically ventilated patients, anemia is associated with increased duration of mechanical ventilation, increased length of stay, and possibly increased mortality. Some research suggested that hemoglobin level \<8.5 g/dl was a potential risk factor for adverse outcome in critically ill patients required mechanical ventilation \>96 hr. However, most researches focused on hemoglobin levels and the associated adverse events in mechanically ventilated patients. To the best of our knowledge, there are few studies reported the impact of the duration of anemia and the clinical outcomes in these patients. We hypothesize that the short duration of anemia developed in mechanically ventilated patients has no effect on duration of mechanical ventilation. We, therefore, aim to investigate the impact of the duration of anemia on duration of mechanical ventilation in critically ill patients required ventilatory support \>96 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose age of equal or more than 18 years old
* Patients admitted to the surgical intensive care unit during the study period
* Patients required ventilatory support with invasive mechanical ventilation for more than 96 hours

Exclusion Criteria:

* Patients whose data regarding time of beginning or ending of ventilatory support missed
* Patients who are previously included in this study and are re-admitted
Bilateral Ultrasound Guided Quadratus Lumborum Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response in Abdominal Surgery

This study aims at comparing the effects of bilateral ultrasound-guided quadratus lumborum block versus lumbar epidural block on postoperative analgesia and inflammatory response following major lower abdominal cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA II, III
* Weight 50 - 85 kg.
* Scheduled for major lower abdominal cancer surgery (radical cystectomy, total abdominal hysterectomy).

Exclusion Criteria:

* Patients with a history of relevant drug allergy.
* Coagulation disorders.
* Opioid dependence.
* Sepsis.
* Local infection at the vicinity of the block site.
* Patients with psychiatric illnesses that would interfere with perception and assessment of pain
A Single Case Study of Hypermetabolism

In the Metabolic Disorder clinic at The Hospital for Sick Children, the investigators identified a male, proband with possible Luft's disease. The investigators hypothesize that Luft's disease is caused by excess or dysregulation of brown/beige fat tissue.

To address the hypothesis, the investigators would like to assess brown fat distribution and activity in this subject.

The subject will undergo a fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography (18F FDG PET/CT) at the Diagnostic Imaging unit of The Hospital for Sick Children.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypermetabolism, possible Luft's disease.

Exclusion Criteria:

* None
Synovial Fluid Analysis of Intraarticular Elbow Fracture

The objective of this study is to obtain and compare bilateral elbow joint synovial fluid from patients with unilateral intraarticular elbow fracture and a contralateral healthy appearing elbow joint. The synovial fluid samples will undergo several forms of analysis for metabolites and proteins. Matched-pair statistical analysis will be performed to determine the metabolites and proteins that may play the greatest role in development of joint contracture.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Intraarticular elbow fracture (humerus, radial head and/or ulna fracture)

Exclusion Criteria:

* Age \<18 years
* Open elbow fracture
* Bilateral elbow fractures
* Patients with history of osteomyelitis of elbow
* Inflammatory arthropathy (ie. Rheumatoid arthritis)
* Prior surgery on fractured elbow
Formal vs. Home-Based Physical Therapy After Unicompartmental Knee Arthroplasty

To determine whether home-based physical therapy (HBPT) is not clinically inferior to formal outpatient physical therapy (OPT) after hospital discharge of patients undergoing a unicompartmental knee arthroplasty (UKA).

Given that current practice trends are requiring treatments to be both clinically and cost effective, research has begun to focus on evaluating the effect of specific interventions. Many surgeon and patients have believed formal OPT is necessary to optimize functional outcomes following orthopaedic procedures. However, the literature has begun to call into question the need for OPT following total hip arthroplasty, total knee arthroplasty, total shoulder arthroplasty, anterior cruciate ligament reconstruction, meniscectomy, and rotator cuff repair.

A randomized controlled trial was done to compare face-to-face rehabilitation with in-home telerehabilitation following total knee arthroplasty. Utilizing the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as the primary outcome, the authors demonstrated noninferiority of telerehabilitation compared to face-to-face rehabilitation. Other secondary outcomes of Knee Injury and Osteoarthritis Outcome Score (KOOS), range of motion, and isometric strength did not exhibit a difference between the treatment groups. (see citation below)

Based on these findings, it appears that the high cost of formal OPT doesn't translate into a meaningful improvement of functional outcome. Because patient's undergoing UKA have a higher pre-operative functional status than patients having a TKA (Total Knee Arthroplasty), it is reasonable to think that patients following a UKA are better equipped to succeed with HBPT. As a result, the hypothesis of the current study is that HBPT will prove to be non-inferior to formal OPT in the setting of UKA.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a unicompartmental knee arthroplasty

Exclusion Criteria:

* Require inpatient physical therapy beyond post-operative day one
* \< 18 years old
* Decline to participate
Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal

AHCL Systems Could Cover Postprandial Glycemic Response After High Fat and High Protein Meals

On the 1st, 2nd and 3rd day of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose measurement system data and optimize the carbohydrate/insulin ratios. On the 4th and 7th days of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose measurement system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on the 11th and 14th days of the study while the participant's pump is in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with a continuous glucose measurement system. The participant will leave the hospital 5 hours after the start of the meal to return to their normal life. Dr Oetker Ristorante Pizza Mista, which was selected as the test meal, was chosen because it is a macronutrient content that is consumed by young people between the ages of 9-18 and that is similar to the test meals in the world literature and accepted research reports reporting the effect of high-fat and high-protein meals on glycemic response in individuals with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Not having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)

Exclusion Criteria:

* - Not volunteering to participate in the study
* Using psychiatric medication or any medication that may cause obesity at the time of trial
* Having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)
Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.

This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to comply with all study procedures and voluntarily signs informed consent form.
* Female subjects age 19-50 years.
* HPV 16 and/or 18 positive.
* Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area
* Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3.

Exclusion Criteria:

* Pregnancy or breastfeeding
* History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded).
* Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
* Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.