cyrilzakka/clinical-trials huggingface dataset:
Depsipeptide in Treating Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of depsipeptide in treating patients who have solid tumors for which no standard therapy exists.

OBJECTIVES: I. Determine the toxic effects and the maximum tolerated dose (MTD) of depsipeptide in patients with incurable solid tumors (per 3/29/00 notification, only patients with cutaneous T-cell lymphoma are being accrued). II. Determine antineoplastic activity of depsipeptide in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients receive depsipeptide IV over 4 hours on days 1 and 5. Treatment continues every 21 days in the absences of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of depsipeptide. If 2 of 6 patients experience dose-limiting toxicity at a given dose level, escalation ceases and the maximum tolerated dose is defined as the previous dose level .

PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for this study within 18-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed incurable solid tumor (per 3/29/00 notification, only patients with cutaneous T-cell lymphoma are being accrued) No known standard therapy for the disease that is potentially curative or definitely capable of extending life expectancy No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 PT/PTT no greater than 1.1 times upper limit of normal (ULN) Hepatic: Bilirubin less than 1.5 ULN AST less than 3 times ULN Renal: Creatinine less than 1.5 times ULN Cardiovascular: Cardiogram must be performed within 1 month of protocol registration No class III/IV heart disease Ejection fraction of at least 45% by MUGA or Echo Other: HIV negative No recent weight loss of greater than 10% of average body weight Oral intake of at least 1,200 calories/day No uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception No serious concurrent illness such as seizure disorder, uncontrolled hypertension, or myelodysplastic syndrome

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) No prior doxorubicin of a total dose greater than 360 mg/m2 Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiation therapy with depsipeptide No prior radiation to greater than 25% of bone marrow Surgery: At least 21 days since prior major surgery
Core Stabilization for the Treatment of Anterior Knee Pain

The investigators hypothesize that the use of trunk (core) stabilization exercises early in treatment combined with lower extremity exercises will enhance the outcome over lower extremity exercises alone in the treatment of young athletes with anterior knee pain.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between 13-20 years of age clinically diagnosed with anterior knee pain.
* Pain should be peripatellar and should include at least 3 of the following:

  1. experienced during or after activity
  2. prolonged sitting
  3. with stair climbing or descending
  4. squatting
  5. kneeling.
* The subject should be active for at least 30 minutes per day.

Exclusion Criteria:

* Previous knee surgery
* Signs and symptoms of a specific structural diagnosis not consistent with AKP such as meniscal, ACL, PCL, or collateral ligament tears, pain referral from hip or lumbar spine (determined during examination), traumatic patellar dislocation, an inability to adequately understand or communicate in English.
Sup-Icu RENal (SIREN)

Data show that episodes of bleeding may often be observed in critically ill patients with dialysis-dependent acute renal failure (ARF) on renal replacement therapy (RRT). From a clinical perspective, patients with dialysis-dependent ARF and end-stage renal disease (ESRD) may be considered a high risk population in regard to e.g. development of gastrointestinal (GI-) bleeding.

In the current prospective subanalysis "SIREN" of the randomized placebo-controlled clinical trial "SUP-ICU" (NCT02467621), the investigators seek to elucidate whether the subpopulation of critically ill patients with acute kidney injury requiring renal replacement therapy (RRT) benefit from prophylactic treatment with a proton-pump-inhibitor such as pantoprazole.


Eligibility Criteria:
Inclusion Criteria:

* please refer to SUP-ICU (NCT02467621) trial

Exclusion Criteria:

* please refer to SUP-ICU (NCT02467621) trial
Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.

The main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. Pemphigus is an autoimmune dermatological disease characterized by the production of anti-desmoclesin antibodies 1 and 3, affecting the skin and mucous membranes.The cicatricial pemphigoid is an autoimmune dermatological disease, characterized by the production of anti-zone antibodies of the basal membrane and characterized by a predominant mucosal involvement. Mycophenolic acid (MPA) is an increasingly used form of corticosteroid. Despite its increasing use, pharmacokinetics in autoimmune bullous dermatosis remain little studied.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years.
* Patient treated by Mycophénolate Mofétil (MMF) per os (Cellcept®) for an autoimmune bullous dermatose (pemphigus or cicatricial pemphigoid) for at least 30 days according to the recommendations (PNDS Pemphigus and cicatricial pemphigoid HAS 2011)
* Patient able to understand the nature, purpose and methodology of the study
* Patient affiliated to the French social security system or equivalent
* Patient who have signed an informed consent form

Exclusion Criteria:

* Pregnant or breast-feeding women or women of childbearing potential without efficient contraception (based on a declaration)
* Patient under legal protection.
* Patient deprived of freedom
* Patient with any altered mental status or any psychiatric condition that would interfere with the understanding of the study.
Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters improve postoperative compared with conventional non-stimulating catheters.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing total hip arthroplasty

Exclusion Criteria:

* diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic
Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut

The purpose of the study is to identify prognostic markers and possible success rate of tolerance induction to peanut allergens in children allergic to peanut.

The study is an open randomized controlled study on oral immunotherapy including 60 children (40 on active treatment, 20 controls) with primary peanut allergy. The study has 4 phases: 1: inclusion/randomization including a double blind placebo controlled food Challenge 2: bi weekly up-dosing to maintenance dose after 48 weeks, 3: maintenance period of 3 years 4: 1 year follow up after end of treatment.

Clinical parameters as well as immunological (serological and cellular) will be recorded at inclusion, after 3 months of up-dosing, at end of up-dosing, after 1 and 3 years of maintenance treatment and after 3 and 12 year of follow up.

Eligibility Criteria:
Inclusion Criteria:

* Positive skin prick test or IgE to peanut
* Age 5-15 yrs
* Primary peanut allergy verified by objective symptoms to DBPCFC by a dose of 3 mg or more peanut potein

Exclusion Criteria:

* Non controlled asthma (by asthma control test, ACT)
* Allergy/intolerance to any other ingredients in the vehicle used for the peanut DBPCFC
* Current or previous allergen specific immunotherapy
* Cardiac disease with increased risk of serious anaphylaxis
* Severe atopic skin disease
* Diabetes mellitus
* Severe disease that interferes with adherence to study protocol
Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.


Eligibility Criteria:
Inclusion Criteria:

* COVID19 positive
* hospitalized because of pneumonia (status #3 - #4 World Health Organization (WHO) scale)
* without contraindications to receive study treatment
* informed consent

Exclusion Criteria:

* receiving corticoids (inhaled or systemic)
* receiving anti Interleukin-1 (IL-1) or anti-IL-6 drugs
* receiving high flow oxygen therapy
* receiving mechanical ventilation
* pregnancy
* participating in another intervention trial for COVID19
Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract

The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract Dermatophagoides pteronyssinus in children with allergic asthma due to this mite

Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive subcutaneous immunotherapy and the other one will receive sublingual immunotherapy).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed by the patient and guardian.
* Positive clinical history of allergy to dust mites.
* FEV1 greater than or equal to 80% of the expected value and improvement in FEV1 greater than 12% after bronchodilation.
* Age-between 5 and 14 years.
* Sensitization to dust mites, diagnosed by positive skin tests to Dermatophagoides pteronyssinus: wheal size \> 3 mm diameter and / or RAST (\> 0.7 kU / L).

Exclusion Criteria:

* Patients out of the age range.
* Use of immunotherapy during the last four years.
* Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:

  * Treatment with ß-blockers
  * Patients who have a condition in which adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc..).
  * Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
  * Patients suffering from immune deficiencies
  * Patients with serious psychiatric / psychological disturbances
* Patients aspirin intolerance
Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder

Borderline personality disorder (BPD) is a severe, high-suicidal psychiatric disorder associated with impulsive, endangering behaviors. Young patients between 16 and 25 years old do not respond to traditional psychotherapies, which are often long and not adapted to their neurocognitive alterations linked to early trauma. The study authors hypothesize the SINTYA therapy program (one group session and one individual session weekly for 10 weeks) would reduce the level of impulsivity and clinical symptomatology (severity of the BPD; emotional regulation difficulties; dissociative symptoms; aggressiveness; ruminations; the number of self-destructive behaviors and suicidal acts; impulsive behaviors; level of suicide risk and hopelessness; the number of psychiatric hospitalizations and emergency visits for psychiatric reasons; and finally improving psychosocial functioning).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of BPD according to DSM-5 criteria and BPQ-80 scale.
* High BPD severity level: ZAN-BPD (score ≥ 18/36).
* Understand, write and read French.
* Be able to understand the nature, purpose and methodology of the study and agree to cooperate during evaluations.
* Have signed the informed consent.
* For minor patients, have signed the parental consent by at least one holder of parental authority.

Exclusion Criteria:

* Refusal to participate.
* Existence of a neurological pathology or cerebral sequelae of organic origin which could affect neurocognitive performance.
* Intelligence quotient \< 70.
* Lifetime diagnosis of schizoaffective disorder or schizophrenia (MINI-7).
* Previous or current participation in specific psychotherapy for BPD.
* Subject deprived of liberty (by judicial or administrative decision) and/or protected by law.
* Inclusion in another study including psychotherapy for the duration of the study.
* Inclusion in a drug RIPH1 study or in a REC study (European regulation of clinical trials) for the entire duration of the study.
* Subject in period of exclusion from another research protocol.
Design of a Predictive Score for Contamination of Pediatric Blood Cultures

The contamination rate for blood cultures is high in pediatrics, due to different sampling techniques and the difficulty of sampling small-weight children, thus favoring contamination of the devices at the time of sampling. It is also more difficult to distinguish contamination from true bacteremia in children at an early stage, notably due to the limited number of vials that can be taken at any one time.

On a daily basis, clinicians are faced with the choice of whether or not to initiate probabilistic antibiotic therapy when faced with the result of a positive blood culture, particularly when identification is not yet available, but only direct examination.

Contamination has major consequences for patient management. Studies in adults have shown that contamination increases hospital length of stay by 4 to 5 days, laboratory costs by +20% and recourse to intravenous antibiotic therapy by +39%. In children, studies came to the same conclusion, with greater prescription of antibiotics, particularly intravenous antibiotics, in patients with contaminated blood cultures than in patients with sterile blood cultures. It also showed that 26% of patients with contaminated blood cultures were initially hospitalized because of the positivity of this test.

The aim of this research is to determine the factors associated with contamination, in order to create a predictive score that would help clinicians in their decision-making when receiving the blood culture result as "positive".


Eligibility Criteria:
Inclusion Criteria:

* Having a blood culture in children's hospital in Nancy
* Under 18 years old
* in emergency department, medical department, intensive care unit or surgical department

Exclusion Criteria:

* immunodepression
* post mortem blood culture
* blood culture in onco-haematology department
Neural Bases of Post-stroke Emotion Perception Disorders

This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs. healthy controls using MRI (functional and structural connectivity) and EEG.

This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs healthy controls (2 groups of 40 subjects). It will include functional MRI, structural MRI (disconnectome), EEG, and behavioral assessments of emotion recognition and executive functions.

Eligibility Criteria:
Inclusion Criteria:

Stroke group:

* Man or Woman
* Age 18-80y
* Unique stroke, ischemic or hemorrhagic
* at the chronic phase (\< 6 months)
* Written informed consent
* subject having a social insurance
* Subject who consent to complete all the study's experiments

Healthy controls group:

* Man or Woman
* Age 18-80y
* No history of neurological or psychiatric disease.

Exclusion Criteria:

Stroke group

* Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)
* History of other neurologic disorders
* Significant le vel of depression or anxiety, assessed by the STAI and the BDI questionnaires
* Non corrected visual loss
* Subjects suffering from visual neglect (assessed by the Bells Test and a bisection test (20mm)
* contra-indications to MRI
* pregnant or breastfeeding woman
* Women of childbearing age without effective contraception

Healthy controls group

* Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)
* History of neurologic disorders
* Significant level of depression or anxiety, assessed by the STAI and the BDI questionnaires
* Non-corrected visual loss
* contra-indications to MRI
* pregnant or breastfeeding woman
* Women of childbearing age without effective contraception
Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis

This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).


Eligibility Criteria:
Inclusion Criteria:

- Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA.

Exclusion Criteria:

* Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant physical examination finding at Screening that in the PI's or designee's opinion may interfere with study objectives.
* Has participated in a previous crisaborole clinical study.
Lactate Levels Correlates With Ki-67 in Brain Tumor Surgery

In neurosurgery, brain tumor patients show increased levels of lactate at the beginning of surgery. This has been related to malignancy. Ki-67 is a cell proliferation index used as a marker of tumor mitotic activity.

This research aims to describe the correlation between lactate levels and the Ki-67 index in patients with brain tumor.

Lactate levels are used in the evaluation of perfusion status in critical care. Increases not related to a hypoperfusion state are observed in the patient with brain tumors. These increases have been related to type and tumor grade. This observation does not fully explain the variation within the same tumor grade.

Ki-67 label index is a marker of mitotic activity that can be used as proliferation index. It has been associated with histologic grade and survival rate. Provides a quantitative measure of the tumor proliferation status.

The investigators will perform a retrospective analysis of the clinical charts of patients after brain tumor resection. The study will address the relationship between baseline lactate levels and the proliferation index found in tissues biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Neurosurgical craniectomy cases
* June 2017 - February 2018
* Valid lactate information after anesthesia induction
* Ki-67 label index informed in biopsies
* Tumor type information confirmed in biopsies

Exclusion Criteria:

* Incomplete lactate or Ki-67 index information
Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients

The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided oral consent
* Patients older than 18
* Patients with type 1 or 2 diabetes
* Patients who can be followed-up in the context of consultations for diabetic foot at the endocrinology, diabetology and metabolic diseases unit of Dijon CHU.
* Lesion situated on a toe or on the plantar or dorsal side of the foot
* Lesion that has evolved for 1 to 24 months

Exclusion Criteria:

* Adult under guardianship
* Patient without national health insurance
* Pregnant or breast-feeding women
* Patients with progressive cancer
* Patients with terminal renal insufficiency on dialysis
* Patient with severe respiratory insufficiency
* Patients with terminal heart failure
* Patients with severe liver failure
* Patients with immunodepriession (treatement with immunosuppressants, long-term corticotherapy, diseases leading to immunodepression)
* Patients with nephrotic syndrome (hypoalbuminemia)
* Patientswith a chronic inflammatory syndrome
* Alcohol consumption greater than 4 glasses per day
* Systemic infection uncontrolled by antibiotics
* Infected lesion with systemic repercussions
* Charcot foot
* Patients taking part or who have planned to take part in another clinical trial
* Severe disease affecting survival in the short term
* Lesion on an amputation
* Lesion of the ankle or leg