cyrilzakka/clinical-trials huggingface dataset:
A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum

The purpose of this study is to determine if treatment with Xionix will improve wound healing for patients with pyoderma gangrenosum.

XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥18
2. History of pyoderma gangrenosum with or without other systemic disease.

Exclusion Criteria:

1. Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
2. Treatment with corticosteroids or cyclosporine within the last 2 weeks.
Sex-specific Differences in AAA Complexity

A retrospective cohort study of computed tomography scans of AAA patients considered for repair, in order to identify sex specific differences in abdominal aortic aneurysm (AAA) metrics and the association between anatomical differences/features of complexity and adverse patient outcome.

A retrospective cohort study of computed tomography scans of AAA patients considered for repair.

The study aims to, firstly, identify sex specific differences in abdominal aortic aneurysm (AAA) metrics utilising manual and automated image processing techniques; and secondly, if numbers are sufficient, explore the association between features of AAA complexity and adverse patient outcome.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with AAA receiving assessment +/- primary open or endovascular repair at participating centre from 1/1/2010 to 31/12/2020.
* Must have AAA \>= 5cm.
* Must have CT imaging within 1 year of operation or definitive turn down for treatment.

Exclusion Criteria:

* Insufficient CT imaging quality (\>3mm slices) or lack of CT within 1 year of operation.
* Insufficient clinical data to establish risk factors or clinical outcomes.
* Ruptured aneurysm, aorto-iliac occlusive disease, isolated iliac aneurysm, penetrating aortic ulcer, dissection, juxta or supra-renal aneurysm.
* Secondary repair/not primary treatment decision for AAA repair.
The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes: CLEAR Study

A prospective, open label, single-arm 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

This is a prospective, open label, multi-center, single-arm trial designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 120 eligible subjects at up 20 sites will participate in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:

   1.1. Subject has failed IV t-PA therapy

   1.2. Subject is contraindicated for IV t-PA administration

   1.3. IV-tPA given within 3 hours of symptom onset
2. Age ≥18 and ≤ 85
3. NIHSS score ≥ 8 and ≤ 25
4. Prestroke mRS score of ≤ 1
5. Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA.
6. Thrombectomy procedure can be initiated within 8 hours from symptom onset (defined as time last known well \[TLKW\]) and at least one NeVa pass occurring within 8 hours
7. Imaging Inclusion Criteria:

   7.1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 , or

   7.2. CT Perfusion core ≤50 cc, or

   7.3. MRI DWI core ≤50 cc
8. Subject or legal representative is able and willing to give informed consent prior to the intervention

Exclusion Criteria:

1. Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
2. Cardiopulmonary resuscitation, cardiac arrhythmia resulting in hemodynamic instability (hypotension) that is not easily medically correctable, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration.
3. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
4. Cerebral vasculitis
5. History of severe allergy to contrast medium.
6. Known allergy to NeVa materials (nitinol, stainless steel);
7. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
8. Systemic infection
9. Significant mass effect with midline shift
10. Evidence of intracranial tumor (except small meningioma \[≤ 3 cm\])
11. Any CT or MRI evidence of acute hemorrhage products on presentation.
12. Inability to deploy NeVa device for at least one pass for any other reason
13. Life expectancy less than 6 months
14. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
15. Females you are pregnant or breastfeeding.
16. Active malignancy
17. Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to the thrombus.
Mechanism of Decompensation Evaluation - Aortic Stenosis

Aortic stenosis is the most common heart valve disease requiring intervention in high income countries. It is characterised by progressive valvular thickening, and restriction as well is hypertrophy and fibrosis of the left ventricle in response to pressure overload. The pathological processes in the left ventricle that ultimately result in heart failure and death are incompletely understood. Further elucidation of these processes and how they correlate with novel blood biomarkers may help us design new treatments and optimise the timing of surgical intervention.

In brief, recruited patients with severe aortic stenosis and scheduled to undergo valve replacement surgery will be invited for some simple tests (blood sampling, ECG, echocardiogram). A septal myocardial biopsy will be taken at the time of surgery and the disease valve retained. These will be examined histologically and pathological changes compared with results obtained from ECG, echocardiogram and blood tests.


Eligibility Criteria:
* Inclusion Criteria (aortic stenosis group):
* Age over 18
* Severe aortic stenosis with planned aortic valve replacement

Inclusion Criteria (control group):

* Age over 18
* Planned non-aortic valve cardiac or elective ascending aorta surgery

Exclusion Criteria (aortic stenosis group):

* Coexistent severe aortic or mitral regurgitation
* Coexistent mitral stenosis greater than mild in severity
* Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)
* Acute pulmonary oedema or cardiogenic shock
* Coexistent hypertrophic cardiomyopathy
* Unable to give informed consent

Exclusion Criteria (control group):

* Significant aortic valve disease (mild aortic stenosis / regurgitation or greater)
* Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)
* Acute pulmonary oedema or cardiogenic shock
* Coexistent hypertrophic cardiomyopathy
* Unable to give informed consent
DAW1033B2 in Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of DAW1033B2 administered before sleep on OSA phenotype traits and OSA severity during sleep.


Eligibility Criteria:
Inclusion Criterion:

* OSA: AHI \> 15

Exclusion Criteria:

* Any medical condition other than well controlled hypertension, diabetes, hyperlipidemia
* Any medication known to influence breathing, sleep/arousal or muscle physiology.
* Claustrophobia.
* Inability to sleep supine.
* Allergy to lidocaine, Oxymetazoline HCl, DAW1033D.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, or any of the studied medications for medical care.
* History of seizures
* For women: Pregnancy.
* History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism
Different Algorithm Models to Predict Postoperative Pneumonia in Elderly Patients

The researchers aim to compare different algorithms to predict postoperative pneumonia in elderly patients and to assess the risk of pneumonia in elderly patients.

Postoperative pneumonia is a common complication that increases the mortality and length of older patients. In order to better assess the risk of postoperative pneumonia in elderly patients, we plan to use database information and different algorithms, such as logistic regression, random forest, and other algorithms respectively to build models and evaluate the effects of the models.

Eligibility Criteria:
Inclusion Criteria:

1. Age 65 years or older
2. receiving invasive ventilation during general anesthesia for surgery

Exclusion Criteria:

1. preoperative mechanical ventilation
2. procedures related to a previous surgical complication
3. a second operation after surgery
4. organ transplantation
5. discharged within 24 hours after surgery
6. cardiac and thoracic surgery
Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages

INTRODUCTION

The expandable cage technology is not new, but several questions remain under-studied. Among them, there are the sagittal balance, the subsidence and the adjacent disc degeneration. Moreover, assessment of the correction and kyphosis regardless of the physiological angles can possibly lead to calculation bias.

The objective of this study was to assess the extent to which the functional outcomes were correlated to the quality of the reduction, within a homogeneous series of lumbar vertebral body reconstruction with expandable cages for trauma.

MATERIAL AND METHODS Twenty-seven patients with a mean follow-up of 3.9 years were retrospectively analyzed. The Oswestry Disability Index (ODI) was the main outcome and its association with other variables was sought. The local kyphosis and the regional traumatic angle using Stagnara's physiological angles were measured. The lumbar lordosis (LL) was compared to the Pelvic Incidence (PI). The subsidence of the cage and the adjacent disc degeneration (using the UCLA grading score) were quantified. Bone quality was assessed through the Hounsfield Unit of the vertebral body.


Eligibility Criteria:
Inclusion Criteria:

* All patients suffered from a traumatic lumbar fracture requiring a posterior fusion first

Exclusion Criteria:

-
Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children

The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.

After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months.

An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients, aged 5-17 years inclusive
* History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s)
* Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)

Exclusion Criteria:

• Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded

* patients sensitised to cat or dog allergens and regularly exposed to these allergens
* patients sensitised to aspergillus, cladosporium, alternaria
* patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region
The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis

The objective of the study is to assess the efficacy and safety of PerioChip® (Chlorhexidine gluconate chip) in the treatment of patients with Peri-implantitis.

The hypothesis of the study is that PerioChip® in adjunct to mechanical subgingival debridement is more effective in the treatment of peri-implantitis when compared to the common method of mechanical subgingival debridement alone. The primary efficacy measure will be the reduction in probing pocket depth at 6 months as measured at sites of qualifying target implant.

This is a research study that uses the drug PerioChip® (active ingredient chlorhexidine gluconate) as an experimental treatment for "periimplantitis". This condition is defined an inflammation affecting the tissues (gums and bone) around an already stable implant, resulting in loss of supporting jaw bone. It is caused by many factors but current research links the condition with the presence of bacteria in the mouth which are responsible for periodontitis (gum disease). If left untreated, this can lead to decreased bone support, weakening of the implant and potential lost of the implant.

Nonsurgical treatment (deep cleaning with instruments to remove plaque) and rigorous diligent oral care at home are commonly used to treat both periimplantitis (gum disease around an implant) and periodontitis (gum disease around teeth).

The medication PerioChip® is a small dental chip (its size is smaller than a match head, and it is completely flat). The chip contains chlorhexidine gluconate, an antimicrobial agent which is not an antibiotic. The chip is inserted into the gum sulcus that is present around the tooth or implant and biodegrades naturally within 7 to 10 days while releasing the medication.

The purpose of this study is to determine the efficacy of PerioChip® in addition to a standard deep cleaning treatment regime, as compared to standard deep cleaning alone.in a large patient population, and to collect additional safety data about the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* At least one implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Including bone loss in combination with bleeding and/or suppuration on probing and a peri-implant Probing Depth (PD) of 5-8 mm.
* The implants have been in function for more than 2 years.
* Fixed prosthetic restoration of the implant.

Exclusion Criteria:

* Pregnancy.
* Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.
* Allergic reaction to Chlorhexidine.
* Active Periodontitis which required definitive treatment.
* Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.
* Use of systemic antibiotic therapy and/or chronically use of non-steroidal anti-inflammatory drugs (NSAIDs).
* Uncontrolled diabetes, of any type.
Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.


Eligibility Criteria:
Inclusion Criteria:

* Intent to undergo correction of cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
* Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:

  1. Collagen, Hyaluronic Acid - 12 months
  2. Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited
Back Muscle Function in Adolescents With Idiopathic Scoliosis

The function and asymmetry of back muscles will be examined in different positions and with specific spinal corrections based on scoliosis pattern and according to the "Schroth method" in adolescents with idiopathic scoliosis.

The study aim is to examine function and asymmetry of back muscles in different positions and with and without specific spinal corrections based on scoliosis pattern and according to "Schroth ethod" in adolescenet idiopathic scoliosis. The will include adolescents aged 10-14 years diagnosed on X-ray with idiopathic scoliosis of 15-400 Cobb angle. Participants will undergo an assessment that includes: demographic questionnaire, pain severity measured by the visual analog scale , quality of life questionnaire for patients with scoliosis (SRS-22), Adam's Forward Bend Test, spine rotation angle assessment using a scoliometer, leg length measurement, hip range of motion using goniometer, Risser sign, Coronal trunk balance and Sagittal vertical axis- according to X-ray, scoliosis classification.

Following examination, participants will perform three exercises that activate back muscles in three different positions: supine lying, side lying and standing. Each exercise will be performed twice: the first time without and the second time with specific corrections of the scoliosis. The exercises will be performed according to "Schroth" method implying that the corrections of the spine will be determined according to the scoliosis pattern and classification for the scoliosis (single / double, thoracic, lumbar etc.) and will be conducted via belts, cushions, and bars.

During each exercise, back muscles thickness will be examined and measured via portable diagnostic ultrasound. The muscles will be measured at T7 and L4 levels in resting and contracting positions. Back muscle function will be evaluated by calculating percentage of change between positions rest and contraction position.

Comparison between muscle function with and without correction and correlation of muscle function to quality of life and other morphological parameters will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents who have been diagnosed by X-ray with idiopathic scoliosis of 15-40°,
* Risser sign zero to four,
* have recent X-rays.

Exclusion Criteria:

* previous back surgery
* have been treated with physical therapy in the past year,
ENRICH Nurse-Family Partnership Study

The overarching goal of the proposed study is to develop and test an enrichment to Nurse-Family Partnership (NFP) using an existing, evidence-based program to improve clients' and their children's cardiovascular health from early pregnancy to 24 months postpartum. With support from NFP supervisors and nurses, the investigators will develop new NFP materials promoting healthy diet, activity, sleep, and smoking behaviors, along with optimal weight, glycemia, lipid, and blood pressure profiles. The investigators will conduct a pilot study with up to 40 NFP clients (or women similar to NFP client population) and their nurses to determine feasibility and acceptability of the materials and study protocol.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant or \<24 months postpartum
* Aged 18 years or older
* English- or Spanish-speaking

Exclusion Criteria:

* \<18 years old
Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction

Hemodynamic instability is frequent during surgery and intraoperative hypotension is associated with excess morbidity and excess mortality in high-risk patients. In major abdominal surgery the incidence of intraoperative hypotension remains high.

For the past few years, some teams have proposed evaluating norepinephrine as a first-line drug in the presence of hypotension or even before hypotension occurs Thus in obstetrics, the preventive use of norepinephrine for cesareans performed under spinal anesthesia was associated with a reduction in the incidence of hypotension per operative without deleterious effect for the newborn or parturient. In the absence of any observed complications, several teams began to use noradrenaline prophylactically in other surgery. However, no study has demonstrated its benefit, particularly the term of surgical complication in abdominal surgery. The objective of this work is to assess the preventive use of norepinephrine in major abdominal surgery on the occurrence of intraoperative hypotension, postoperative organ dysfunction and postoperative medical and surgical complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for major abdominal surgery
* ASA 2 or more patients
* Adults\> 50 years old
* Patients eligible for general anesthesia

Exclusion Criteria:

* Patients scheduled for will be excluded and excluded from the study:
* ASA 1
* Children and adults \<or = 50 years old
* Urgent surgery
* Allergy to a product used in the study
* Severe untreated or uncontrolled high blood pressure despite taking medication
* Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome
* Chronic kidney disease with a glomerular filtration rate of less than 30 ml / min / 1.73 m2 or requiring renal replacement treatment in the event of end-stage renal failure
* Preoperative sepsis
* Circulatory shock
* Preoperative noradrenaline infusion before entering the study
* Surgical procedure under regional anesthesia (epidural and spinal anesthesia)
* No affiliation with the French health system
* Participation in another concurrent intervention study
* Refusal to participate
* Pregnant or lactating women