cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Analgesic Effect of Transcranial Direct Current Stimulation (tDCS) for Sedated Patients in Intensive Care Unit.

Pain management for sedated ICU patients is complex, partly because of the difficulty of assessing pain in non-communicative patients, and partly because of the side effects associated with excessive use of morphine.

In this context, the use of another non-pharmacological approach, transcranial direct current stimulation (tDCS), could be of interest. With tDCS, neuronal activity is modulated by inducing a weak electric current through the cerebral cortex between two electrodes applied to the surface of the scalp. Although the mechanisms of action of tDCS are not yet fully understood, the medium-term effects are thought to be linked to the activation of N-methyl-D-aspartate receptors, glutamate-activated receptors involved in cellular memory. The use of tDCS as an analgesic therapy for chronic pain has produced encouraging results in patients suffering from fibromyalgia, migraine and central pain following spinal cord injury, Its use in sedated intensive care patients is unknown. To assess the possible analgesic effect of tDCS in these patients, we will use quantitative pupillometry, a technique already used in routine intensive care, to quantify nociception during a standardized nociceptive simulation.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 80 years,
* Sedated patient in stable condition requiring mechanical ventilation for at least 72 hours with continuous administration of morphine.
* Person affiliated to the social security system or beneficiary of an assimilated regime.
* Close consent or emergency inclusion

Exclusion Criteria:

* History of epilepsy.
* Severe brain injury (head trauma, stroke, neuromeningeal infection, status epilepticus).
* Presence of intracranial ferromagnetic material.
* Presence of electronic stimulators or implants (e.g. pacemaker, spinal cord or intracranial stimulator).
* Facial trauma preventing eye opening.
* Patients who are blind and/or have eye damage.
* Protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons under legal protection.
* Subjects excluded from another study.
Microbiome in Atopic Dermatitis Under Systemic Therapy

The skin microbiome plays a role in the pathogenesis of atopic dermatitis. However, it is unclear whether the range of microbiota on the skin is the cause or consequence of atopic skin inflammation.

The influence of new systemic therapies for the treatment of moderate to severe atopic dermatitis (such as biologics or Janus kinase inhibitors) on the skin microbiome is largely unknown.

The main aim of this scientific exploratory study is to investigate whether and how the skin microbiome changes in patients with moderate to severe atopic dermatitis during systemic therapy. This not only allows new hypotheses to be generated on the pathogenesis of atopic dermatitis, but also new objective scales for the severity of atopic dermatitis can be developed.

A better understanding of the pathology of atopic dermatitis could lead to the development of new therapeutic strategies for this disease and contribute to better and more targeted disease management - an advantage for all patients with atopic dermatitis.

The routine examinations are carried out every quarter with routine visits over two years. The dates before, 6, 12, and 24 months after the initiation of systemic therapy are relevant for this study. Deviations from normal practice are not intended.

Patients in whom a new initiation of systemic therapy is planned will be invited for a follow-up 6 weeks after initiation and quarterly follow-up visits.

Blood samples must be obtained for the examination. The blood is taken to determine the systemic level of inflammatory mediators (serological biomarkers, PBMCs) and for genetic examinations (e.g. filaggrin gene mutation - FLG) as well as mRNA / lncRNA profile. The skin physiological examinations are not invasive or pain-related procedures. Microbiome sampling will be conducted by a skin swab of the inter-scapular region.

The blood / skin samples taken as part of this scientific study are pseudonymized in the research laboratories. The samples are stored in the laboratories for a period of 5 years after the end of the study and then destroyed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe atopic dermatitis
* Indication for systemic therapy

Exclusion Criteria:

* Patients under 18 years of age upon introducing systemic therapy
* Pregnant and lactating women
T1D, Metabolic Syndrome and Insulin Resistance

Patients with type 1 diabetes (T1D) and metabolic syndrome (MS) require high doses of insulin to achieve a glycemic control, due to insulin resistance (IR). The investigators identified the presence of metabolic syndrome and insulin resistance in patients with T1D in a population of southeast Mexico.

The sampled population was recruited from the Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez"; from August 2021 to February 2022, graduated physicians interviewed patients previously diagnosed with T1D. This study included patients older than 18 years and at least six months after being diagnosed with T1D. The interviewers excluded patients who did not attend regular consultations and those who did not agree to participate or to give a blood sample. A diabetologist evaluated and diagnosed all patients based on the World Health Organization (WHO) criteria.

Fasting glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols were determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics. The reasearch team determined glycated hemoglobin concentrations by an enzymatic immunoassay method.


Eligibility Criteria:
Inclusion Criteria:

* At least six months after being diagnosed with T1D

Exclusion Criteria:

* Did not attend regular consultations
* Did not agree to participate or to give a blood sample
Androgens and Subclinical Atherosclerosis in Young Women - Ancillary to CARDIA

To examine whether serum androgens, measured earlier in life, and variation in genes related to androgen synthesis, metabolism, and signaling are associated with early-onset subclinical coronary atherosclerosis in young adult women from the community.

BACKGROUND:

Polycystic ovary syndrome (PCOS) is denoted by hyperandrogenism and symptoms of ovulation dysfunction (e.g., infertility, oligomenorrhea). Women who are diagnosed with PCOS represent the more extreme end of abnormal ovarian function. While PCOS is rare, approximately 20 percent of women are expected to have subclinical polycystic ovaries, identified by sonogram. Factors that are associated with PCOS, insulin resistance and dyslipidemia, are also risk factors for coronary artery disease and there is evidence to suggest that women with PCOS are more likely to experience coronary artery disease. This raises the question: are subclinical cases of polycystic ovaries at increased risk of coronary artery disease?

The study is ancillary to the the Coronary Artery Risk Development in Young Adults (CARDIA) Study, a large cohort study supported by the NHLBI. The CARDIA population provides a unique opportunity to explore these associations because there is a 15-year period of risk factor ascertainment in this population including stored blood + DNA specimens from which serum androgens and relevant genetic markers can be ascertained. In addition, all participants will have coronary artery calcium (CAC) determinations at the year 15 exam. In the ancillary study an additional year 16 visit will occur for the purpose of obtaining a trans vaginal ultrasound determination (TVUS) so as to obtain clinical evidence of hyperandrogenism and look at the joint effects of the clinical evidence and serum markers as predictors of CAC. The study is in response to an initiative on Ancillary Studies in Heart, Lung, and Blood Disease Trials released in June, 2000.

DESIGN NARRATIVE:

The ancillary study in year 16 of CARDIA will recall 1,200 women who received a coronary artery calcification (CAC) determination in year 15. These women will have an additional blood draw three to 10 days after their last menstrual period, will have a questionnaire administered to them regarding clinical symptoms of PCOS (polycystic ovarian syndrome) and other aspects of hyperandrogenism. Two principal analyses will be performed. The first is a longitudinal analysis using year 2 and year 10 data to use serum markers of hyperandrogenism and genetic markers from DNA samples as predictors of CAC which is defined as present (absent) and is determined at the year 15 examination. The principal method of analysis will be logistic regression. An additional analysis will relate androgen levels at year 2 to lipid levels and other coronary risk factors ascertained at year 2, 7, 10 and 15.

Eligibility Criteria:
No eligibility criteria
The Effectiveness of Lymphatic Bypass Supermicrosurgery

This study evaluate the effectiveness of lymphatic bypass supermicrosurgery (LBS) and axillary lymph node dissection (ALND) compare to ALND alone to prevent breast cancer treatment-related lymphedema (BCRL).

In the intervention group, LBS was performed after ALND with the intima-to-intima coaptation using the supermicrosurgery technique. The anastomosis is done between the afferent lymphatic vessel to the recipient's vein, or if possible, from the afferent to the efferent lymphatic vessel. The upper extremity lymphedema (UEL) index and indocyanine green (ICG) lymphography are utilized to evaluate the development of lymphedema.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patient aged \>18 years old
* Breast cancer patient with clinically ALNs metastases (cN1 or cN2).
* Breast cancer patient with no clinical metastasis and tumor size ≥5cm or no sentinel lymph node biopsy facility in the hospital.
* Any breast cancer patients that receive neoadjuvant systemic therapy.

Exclusion Criteria:

* Stage IV breast cancer patients who do not show clinical and radiological improvement after primary systemic therapy.
* Breast cancer patients with previous surgeries such as mastectomy, axillary lymph node biopsy, sentinel lymph node biopsy (SLNB), and ALND.
* Breast cancer patients with prior breast, chest wall, axillary, or neck radiotherapy.
* Breast cancer patients with preoperative lymphatic system abnormality detected by ICG lymphography.
* Breast cancer patients with iodine allergy, asthma, decreased kidney function, pregnancy, and lactation.
Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results

This study evaluates the Visual Acuity and refraction of patients post 4-point Scleral fixation of BunnyLens (Intra Ocular Lens- IOL) with GoreTex sutures. All patients underwent secondary IOL implantation or IOL exchange during 2014-2017.

4 point scleral fixation of PC- IOL (Posterior Chamber-PC) BunnyLens with Gore-Tex sutures is a surgical technique for implanting IOL in patients with capsular support absence, due to trauma, abnormal anterior chamber, IOL dislocation, or ciliary zonule defect.

The 4 point fixation enables to align the PC- IOL with minimal vertical and horizontal deviation;The Gore-Tex sutures maintain stable scleral fixation with no suture erosion or breakage.

Eligibility Criteria:
Inclusion Criteria:

* patients that underwent secondary cataract surgery or IOL replacement and BunnyLens fixation with Gore-Tex sutures.

Exclusion Criteria:

* Lack of Cooperation, death, severe physical or mental illness, patient's request to withdraw of the clinical trial.
High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of thalidomide combining with high-dose dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone mono-therapy.

The investigators are undertaking a multicenter, randomized controlled trial of 200 primary ITP adult patients from 5 medical centers in China. One part of the participants are randomly selected to receive Thalidomide (given at a dose of 150mg for 15 consecutive days), combining with dexamethasone (given intravenously at a dose of 40 mg per day for 4 days, the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days).

Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of thalidomide combining with high-dose dexamethasone therapy compared to high-dose dexamethasone for the treatment of adults with ITP.

Eligibility Criteria:
Inclusion Criteria:

* •newly diagnosed ITP patients need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia

Exclusion Criteria:

* •pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment hepatitis C virus, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome
A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).

This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.


Eligibility Criteria:
Inclusion Criteria:

* Participant is in good physical health-
* Participant's parent/legal guardian is able to read, understand, and complete the vaccine report card
* Participant's parent/legal guardian agrees to provide a phone number for follow-up purposes
* Participant is not sexually active and does not plan to become sexually active during the time from Day 1 to Month 7 of the study

Exclusion Criteria:

* Participant has a history of severe allergic reaction that required medical intervention
* Participant has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
* Participant is pregnant
* Participant intends to donate blood during the time from Day 1 to Month 7 of the study
* Participant is immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
* Participant has had a splenectomy
* Participant has received any of the following immunosuppressive therapies in the year prior to enrollment: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies, antilymphocyte sera, or other therapy known to interfere with the immune response.
* Participant has received any immune globulin product or blood-derived product in the three months prior to the Day 1 vaccination, or plans to receive any such product through Month 7 of the study
* Participant has received any inactivated vaccines within 14 days of the Day 1 vaccination or any live vaccines within 28 days of the Day 1 vaccination
* Participant has received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
* Participant has had a fever (oral temperature ≥37.8°C) within 24 hours of the Day 1 vaccination
* Participant has a history of a positive test for HPV or history of genital warts
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* rheumatoid arthritis for \>=6 months;
* previous inadequate response to a single anti-TNF alpha inhibitor;
* methotrexate at a stable dose range 7.5-25 mg/week.

Exclusion Criteria:

* other chronic inflammatory articular disease or systemic autoimmune disease;
* previous treatment with MabThera or intolerance to MabThera;
* corticosteroids\>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at unstable doses within last 2 weeks;
Investigating Eye-Movement Biomarkers of Disease Severity and Cognition in Multiple Sclerosis

The overarching goal of this research protocol is to acquire eye-tracking, cognitive, and disease-severity metrics in multiple sclerosis (MS) patients to further build up a database of MS patients and train a machine learning classifying algorithms to identify which eye-tracking metrics-or combination thereof-can serve as reliable markers of MS disease severity and cognitive status.

This study will use a single group design in a cohort of MS patients. Eligible patients with MS will be selected and categorized based on their Expanded Disability Status Scale (EDSS) score. Patients eye movements will be captured using the patented eye-tracking technology at one single time point. In addition to the eye-tracking tests, patient phenotypes will be further detailed via brief functional and cognitive assessments using the EDSS, Brief International Cognitive Assessment for MS (BICAMS) and Multiple Sclerosis Functional Composite (MSFC). All patients will be required to participate in a single session.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent.
* Aged 18 years or older at the time of enrollment.
* Able to read in either French or English.
* Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc. are permitted)
* Confirmed diagnosis of MS with no signs of progressive increase in physical disability within the past six months.
* Neurological condition is medically stable during the study visit.

Exclusion Criteria:

* Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
* Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
* Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments.
* Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment
* Diagnosis of Clinically Isolated Syndrome (CIS), Radiologically Isolated Syndrome (RIS) or Primary Progressive MS (PPMS).
* Patients who are currently experiencing a relapse or who have experienced a relapse within the last three months. A relapse is defined as appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must have been present for at least 24 hours and occurred in the absence of fever (\< 37.5°C) or known infection.
* Patients who have been undergoing disease-modifying therapy for less than three months
Intermittent Hypoxia in Persons With Multiple Sclerosis

This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS.

Recent research has shown that AIH, characterized by brief episodes of reduced oxygen levels in the inspired air, has the potential to induce neural adaptations. These adaptations are suspected to influence several aspects of neuroplasticity, including the modulation of neurotransmitters and neurotrophic factors. Persons with MS typically exhibit greater cortical activation to achieve a given motor task compared to healthy controls, suggesting compensatory activations in motor cortices and the recruitment of additional non-motor regions for successful motor control. Therefore, interventions that promote adaptive neuroplasticity in motor control systems may induce a reduction in fMRI activation during motor tasks as well as an increase in functional connectivity between somatomotor cortices. This study will explore potential mechanisms of this intervention in MS using motor task performance and advanced neuroimaging techniques.

Eligibility Criteria:
Inclusion Criteria:

* Diagnoses of relapsing form of MS (including relapsing-remitting MS and secondary-progressive MS)
* Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5
* Motor Functional System Scale (FSS) between 2-4
* Relapse free for at least 1 year
* Age ≥ 18 years and ≤ 75 years
* Safe to be scanned based on MRI questionnaire
* Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening

Exclusion Criteria:

* Active contrast-enhancing MS lesions, or diffusion positive lesions suggestive of acute cerebrovascular disease on baseline MRI scan
* Uncontrolled hypertension (Systolic between 85 and 140, diastolic between 90 and 55)
* History of epilepsy
* Chronic obstructive pulmonary disease
* Uncontrolled Sleep apnea
* Pregnancy