cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Impact of Psychological Profile on Diabetic Foot Wound Healing. Prospective, Monocentric Study

Foot wounds in patients with diabetes are one of the most frequent complications associated with diabetes. Despite the progress made in its management in recent years, the risk of amputation remains high in cases of diabetic foot wounds.

Several studies have highlighted the value of analyzing the psychological profile A or B, defined by self-questionnaire using Bortner's method. The A personality profile is characterized by hyperactivity, combativeness and exaggerated ambition, while the B profile is characterized by less sensitivity to stress and reduced combativeness.

Type A personality profile is associated with reduced cardiovascular mortality in type 1 diabetes. Type B personality profiles have also been shown to be associated with inflammation in both type 1 and type 2 diabetes.

Our group showed that patients with diabetes and a foot wound were more likely to have a type B psychological profile than patients with diabetes and no foot wound.

However, to our knowledge, it has never been determined whether the psychosomatic profile type A or B assessed by the Bortner self-questionnaire influenced wound healing and the risk of amputation.

The aim of this study is to determine whether type A or B psychosomatic profile influences wound healing in diabetic feet.

This study will be carried out in the endocrinology, diabetology and nutrition department of the Dijon Bourgogne University Hospital. 308 patients will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Person who has given his non-opposition
* Person over 18 years of age
* Person with type 2 diabetes
* Person referred for management of a new diabetic foot wound

Exclusion Criteria:

* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to a legal protection measure
* Pregnant women, women in labour or breastfeeding mothers
* An adult who is incapable or unable to give consent
* Minors
* Person unable to complete self-questionnaires
IVI Aflibercept Before and After Phaco in DME.

To study whether or not cataract surgery should be deferred until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF).

A prospective randomized interventional study included diabetic patients with visually significant cataract and DME. Patients were divided into 2 groups. Group A received three pre-operative intravitreal Aflibercept injections with a monthly interval, the third injection was given intra-operatively. Group B received a single intra-operative injection, and two post-operative injections with a monthly interval. follow up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

- Diabetic patients with visually significant cataract

Exclusion Criteria:

* previous vitreoretinal surgery
* laser or intravitreal injections 6 months prior to the procedure
* intractable glaucom
* active intra-ocular inflammation
* retinal detachment
* vitreous hemorrhage
* epi-retinal membranes
* any other retinal vascular or neuroretinal disease.
* Patients with eventual cataract surgeries
Combination Therapy With Carfilzomib for the Antibody-Mediated Rejection Diagnosis in Lung Transplantation

The clinical trial is a Phase II open label, single-arm pilot study to evaluate the safety and efficacy of combination therapy with carfilzomib, plasma exchange and intravenous immunoglobulins for AMR after lung transplantation and elucidate important clinical and immunologic phenotypes and mechanisms associated with these outcomes.

The main objective of the proposed clinical investigation is to evaluate the effects of carfilzomib in addition to conventional therapy on short-term outcomes after the diagnosis of antibody-mediated rejection in lung transplant recipients. In this study, Carfilzomib will be administered at a dose of 20 mg/m2 on two consecutive days, each week for three weeks (Days 1 2, 8, 9, 15, and 16) to constitute one therapeutic cycle. Carfilzomib may be administered for 1-2 complete cycles in the study. Patients will be followed for the duration of their hospital admission after enrollment. Post treatment follow-up will also occur on Days 42 and 90.

Eligibility Criteria:
Inclusion Criteria:

* Adult lung transplant recipients ≥ 18 years of age who meet the diagnostic criteria for AMR and who have underwent PFT testing unless intubated and transbronchial biopsy prior to enrollment.

Exclusion Criteria:

* Direct contraindications or previous intolerances to any component of the standard of care regimen including PLEX, 5% human albumin, 5% gammagard S/D or 10% gammagard liquid
* Leukopenia
* Neutropenia
* Thrombocytopenia
* Known Child-Pugh B/C cirrhosis
* Total bilirubin \> 4
* ALT \> 90
* Known systolic heart failure with LVEF \< 40%
* Known pulmonary hypertension
* Any uncontrolled comorbid condition
* Pregnant women
* Breastfeeding women
* Ongoing bacterial or fungal or viral infection that is life-threatening
* Active cytomegalovirus disease
* Active varicella zoster infection
* Previous intolerance to carfilzomib
* Concurrent use of another proteasome inhibitor (e.g., bortezomib)
Hybrid Device DIALYTRODE for Multimodal Neuro-monitoring of Patients With Brain Injury and Status Epilepticus

This clinical trial evaluates the safety and diagnostic performance of a newly developed combined catheter that will be implanted into the brain of patients with severe brain injury for short time (up to 28 days) monitoring of the electric activity and the metabolism of brain tissue at risk. Ten patients will be monitored with the new device and seven patients will be monitored by intracerebral probes according to standard treatment.

Early detection of nonconvulsive status epilepticus (NCSE) in patients treated in neurological intensive care unit (NICU) is essential, as delayed treatment can aggravate their clinical situation and worsen the outcome. In this study in intensive care patients with severe brain injury due to malignant middle cerebral artery (MCA) infarction, subarachnoidal hemorrhage (SAH) or intracerebral hemorrhage (ICH) with suspected status epilepticus in the surface EEG the hybrid catheter Dialytrode will be implanted in the cortical brain tissue by neurosurgeons for short time continuous bedside multimodal neuro-monitoring. Dialytrode combines a microdialysis catheter and depth EEG probe. Ten subjects will be monitored by Dialytrode and an additional (intracranial pressure (ICP) probe. Subjects with an clinical indication of an external ventricular drain (EVD) or cerebral microdialysis alone serve as control. The monitoring period with the device is limited to the microdialysis phase with a maximum of 28 days. Subjects will be followed up for 7 days after end of intracerebral monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical condition requiring treatment in NICU
2. MCA OR Subarachnoidal haemorrhage (SAH) OR Intracerebral haemorrhage (ICH)
3. Given indication of EVD with or without multimodal monitoring by micro-dialysis OR Given indication of multimodal monitoring by micro-dialysis and continuous depth EEG-monitoring due to (a) suspected SE in surface EEG (e.g. rhythmic pattern) or (b) refractory status epilepticus (RSE) in surface EEG or (c) an unclear situation of not waking up even though sedation is reduced OR Suspected SE without acute brain injury

Exclusion Criteria (main criteria):

* Subject receiving anticoagulants in therapeutic dose
* Bleeding disorder
* Known contraindications for EEG depth electrodes or microdialysis probes
* Presence of an infectious lesion of skin (limited to the scalp)
* Presence of general contraindications for any surgical intervention
* Sepsis or acute severe bacterial infection
* Fragile bones of the skull
* Severe organ failure or medical conditions displaying a contraindication for participating
* Pregnant or nursing woman
Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV

Chemotherapy-induced nausea and vomiting is a common side effect of cancer treatments, and dexamethasone offers a clear advantage over placebo for protection against chemotherapy-induced emesis in both acute and delayed phases. However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns. Several clinical trials have shown that olanzapine plays an important role in treating delayed, refractory, breakthrough nausea and vomiting. Its side effects mainly include sedation and weight gaining. At present, the NCCN guidelines have recommended olanzapine-containing three-drug regimen for Highly Emetogenic Chemotherapy (HEC) and moderate emetic chemotherapy (MEC) to prevent vomiting, but its data in the Chinese population is limited. Hence, we initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: applying olanzapine to prevent CINV instead of dexamethasone.


Eligibility Criteria:
Inclusion Criteria (Patients are eligible to be included in the study only if they meet all of the following criteria):

1. Cancer patients, age ≥ 18 years and ≤75 years, ECOG score 0-2 points, receiving cisplatin-containing doublet chemotherapy such as cisplatin + gemcitabine / albumin paclitaxel / etoposide /fluorouracil / irinotecan / temozolomide as first line treatment;
2. Life expectancy ≥ 3 months;
3. Leucocytes≥3,000/uL;
4. AST≤2.5 × upper limit of normal;
5. Bilirubin ≤1.5 × upper limit of normal;
6. Serum creatinine ≤ 1.5 × upper limit of normal.

Exclusion Criteria (Patients will be excluded if any of the following criteria is met):

1. History of CNS disease, such as brain metastases or epilepsy;
2. Use of other antipsychotic drugs (such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone, or such treatment is under scheduling during the study) within 30 days before enrollment; long-term use of phenothiazine as an antipsychotic agent;
3. Concurrent use of pharyngeal or abdominal radiotherapy;
4. Concurrent use of quinolone antibiotics;
5. Chronic alcoholism;
6. Known hypersensitivity to olanzapine;
7. Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;
8. Known uncontrolled diabetes mellitus;
9. Vomiting or retching 24 hours before chemotherapy;
10. Use of anti-emesis drugs 48 hours before chemotherapy;
11. Concurrent use of amifostine;
12. Concurrent use of corticosteroids and the only anti-allergic choice is corticosteroids
15% TOPICAL RESORCINOL FOR HURLEY I-II HIDRADENITIS SUPPURATIVA.

Prospective, observational cross-sectional study to evaluate the response of patients with HS I-II to monotherapy treatment of topical resorcin 15%, taking into account its safety, impact on quality of life and subclinical evolution.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Diagnosed with HS Hurley I-II degree.
* Patients that have at least 1 or more swollen up nodules and/or abscess.
* Availability of affected region control ultrasound prior to resorcine treatment beginning.

Exclusion Criteria:

* Age \< 18 years.
* Number of draining fistula above 20.
* Patients in active treatment with immunomodulators.
* Patients in active treatment with antibiotics.
Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:

* Will the patient reported outcomes differ between the two groups?
* Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken.

The purpose of this study is to compare two different total knee arthroplasty (TKA) robotic assisted (RA) devices. This study will compare patient reported outcome measures prior to and after surgery. These surveys will be used determine if there are differences in patient recovery after TKA depending on the robot used. Radiographs will also be taken and used to compare component positioning. Intraoperative data will be collected to compare OR efficiency of the two systems.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be a candidate for primary TKA (either Stryker Triathlon with MAKO Robotic-Arm or DePuy Attune with VELYS Robotic-Assistance).
* Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of information to the Sponsor.
* Individuals who are willing and able to complete follow up visits, questionnaires, and radiographic evaluations as specified by the study protocol.
* Individuals who are male or non-pregnant female age 18-80 years at time of device implantation.
* Patient has a diagnosis of primary osteoarthritis or degenerative joint disease of the knee.

Exclusion Criteria:

* Patient has a Body Mass Index (BMI) \> 40.
* Patient has been diagnosed with osteoporosis or displays poor bone quality per the discretion of the investigator.
* Patient has an active or suspected latent infection in affected knee joint. Patient has neuromuscular or neurosensory deficiency.
* Patient is diagnosed with systemic disease or metabolic disorder (e.g., Lupus, Charcot's. Paget's).
* Subject is a woman who is pregnant or lactating.
* Patient has a contralateral amputation.
* Patient's affected knee has a flexion contracture greater than 15 degrees.
* Patient has history of post operative arthrofibrosis.
* Patient's affected knee has a partial knee arthroplasty.
* Patient has undergone contralateral TKA within the last three months.
* Patient is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims.
* Patient who is bedridden per the discretion of the investigator.
* Patient has a medical condition with less than 2 years of life expectancy.
Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.

This is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira Vitality silicone hydrogel Toric lenses (fanfilcon A).

Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft toric contact lens wearer
* Has a contact lens spherical prescription between +6.00 to -8.00 (inclusive)
* Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Has a CL prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Slit lamp findings that would contraindicate contact lens wear such as:
* Pathological dry eye or associated findings
* Pterygium, pinguecula, or corneal scars within the visual axis
* Neovascularization \> 0.75 mm in from of the limbus
* Giant papillary conjunctivitis (GCP) worse than grade 1
* Anterior uveitis or iritis (past or present)
* Seborrheic eczema, Seborrheic conjunctivitis
* History of corneal ulcers or fungal infections
* Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
Prophylactic Effect of Lamotrigine Compared With Lithium in Bipolar Disorder

The purpose of this study is to compare lamotrigine with lithium in the long term treatment of bipolar disorder in terms of new episode preventive potentials.

Bipolar disorder is a recurrent lifelong illness. Lithium is still the drug of first choice in the prophylactic treatment. However, lithium's side effects are considerable. Thus the interest in developing alternatives to lithium has increased, and various antiepileptic drugs have been studied. Among these, lamotrigine, which generally is well tolerated, has been evaluated in industry generated trials. However, for various reasons, the generalisability of the results from these studies is limited. Also the follow-up time is limited. This study is a pragmatic effectiveness study, overcoming some of these limitations, and comparing lamotrigine with that of lithium in terms of their potentials for preventing new episodes in patients with bipolar disorder.

Eligibility Criteria:
Inclusion criteria:

1. Age above 18
2. Inclusion is preceded by an affective episode requiring hospitalisation or outpatient drug treatment (index episode) which can be a manic episode (ICD-10 research criteria), a depressive episode of at least moderate degree (ICD-10 research criteria) or a mixed manic state (manic episode with at least additional three ICD-10 depressive symptoms except for difficulties with concentration or thinking, agitation or dyssomnia). The episode can be with or without psychotic symptoms including Schneiderian first-rank symptoms or bizarre delusions as long as the psychotic symptoms do not occur outside the affective episode.
3. No more than 12 months may pass between the onset of the index episode (or admission if that is the case)and date of randomisation (in order to ensure a current risk of relapse as well as reliable psychopathological information).
4. Besides the index episode, at least one previous episode must have occurred within the last five years which meets the criteria mentioned in point number two above. This episode may not necessarily have led to hospitalisation. Two episodes are separated by at least two months without significant symptoms or change in polarity (depression to mania/mixed mania or vice versa).
5. At least one manic episode (or mixed manic episode) within the last 5 years.

Exclusion criteria:

1. Contraindications to the protocol drugs.
2. Severe somatic disease, e.g. epilepsy, which may interfere with study treatment or effect evaluation.
3. Pregnancy (or risk of pregnancy).
4. Subject has prior to randomization received prophylactic treatment with lithium or lamotrigine conducted adequately in the sense of sufficient time and dose and ensuring compliance, and experienced a definite lack of prophylactic effect
5. An ICD-10 diagnosis of abuse within the last year with a subsequent risk of protocol violation. Therefore, subjects with a secondary abuse can often be included in the study.
6. Anticipated protocol violation for other reasons.
7. No written informed consent from the subject can be obtained.
8. The subject has previously been randomised in the study.
An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice

The aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 55-65 years, diagnosed with invasive early breast cancer: - Surgery, chemo- and/or radiotherapy concluded less than 6 months ago
* Women with hormone-independent breast cancer: - Surgery, chemo- and/or radiotherapy concluded before 24-36 months or 54-66 months
* Women with hormone-dependent breast cancer:- Adjuvant therapy with tamoxifen initiated before 24-36 and 54-66 months or - Adjuvant therapy with aromatase inhibitor initiated before 24-36 and 54-66 months or - Switch from tamoxifen to aromatase inhibitor initiated before 24-36 months

Exclusion Criteria:

* Women receiving active treatment for osteoporosis
* Women with any evidence of breast cancer recurrence
The Visual Effect of an Investigational Artificial Tear in the Tear Layer.

The purpose of this study is to investigate how the addition of a new artificial tear product when applied to the tear layer affects contrast sensitivity and optical aberrations over time. We will also determine if there are any adverse effects associated with drop instillation.

Artificial tears are applied to the eye to treat a variety of eye conditions. These conditions typically are associated with dry eyes and include tear film deficiency due to ocular or systemic disease, lid resurfacing problems, and contact lens wear. The artificial tears are used to alleviate the dry eye symptoms. The administration of an artificial tear to the eye can disrupt the tear layer and this disruption could then result in a decrease in contrast sensitivity.1 - 6

Temporal changes in tear film structure (e.g., drying of the tear layer) can distort the optical wavefront as it passes through the tear layer and subsequently reduce contrast sensitivity.1 Theoretically, any substance applied to the tear layer that alters its structure could affect contrast sensitivity. Previous work in our lab has demonstrated that Refresh Liquigel when applied to the tear layer of non-contact and contact lens wearing subjects can decrease contrast sensitivity.4, 5, 7 In this study, we propose to examine the effects of a new investigational artificial tear on contrast sensitivity and optical aberrations for up to 30 minutes after administration into the tear layer of normal and dry eye subjects. A questionnaire will also be used to determine the opinions of the subjects concerning this new artificial tear.

Eligibility Criteria:
Inclusion Criteria:

* Thirty subjects free from ocular pathology will be chosen. Ten of the subjects will have a normal tear layer, ten will have a mild dry eye, and ten will have a moderate/severe dry eye. All subjects will be over the age of 18. Best corrected visual acuities will be at least 20/25 on a standard Snellen acuity chart at distance.

Exclusion Criteria:

* Subjects will be excluded from this project if they have, or during the course of the experiment they develop, an allergy to the eye drops used in this project.