cyrilzakka/clinical-trials huggingface dataset:
Analysis of Disturbances in Neurofluid Dynamics in Type I Chiari Malformations

A global analysis of craniospinal hemodynamics and hydrodynamics is necessary to better understand the pathophysiology of Chiari malformations. This includes an analysis of intraventricular CSF flow, intracranial subarachnoid spaces, foramen magnum, cervical subarachnoid spaces and within the syringomyelia cavity when present. The investigators will also analyze the pulsatility of the cerebellar tonsils in the foramen magnum. Hemodynamic analysis will be performed at the high cervical level (internal carotid and vertebral arteries, jugular veins) and intracranially (carotid and basilar arteries, right sinus and superior longitudinal sinus). This analysis will be made possible by PCMRI acquisitions with slice planes allowing the analysis of the dynamics of the CSF (mesencephalic aqueduct, prepontic cisterns, foramen magnum, at the level of the C2C3 disc, syringomyelia if present), cerebellar tonsils (foramen magnum). The cross-sectional planes for hemodynamic analysis will be at the level of the C2C3 disc (cervical vascular analysis) and upstream of the polygon of Willis (intracranial vascular analysis).

The goal is to complement the clinical and morphological investigations with quantitative imaging of cerebrospinal fluid (CSF) and blood flow in the craniospinal system. These flows are potentially altered or causes of this Chiari anomaly.

The investigators propose a translational research project of clinical research allowing the analysis of a diagnostic technique by a diagnostic, monocentric, prospective study. After neurosurgical consultation, patients with Chiari malformation will be assigned to a symptomatic Chiari malformation or a non-symptomatic Chiari malformation group. They will be offered to participate in this study after information and informed consent. The allocation between the two groups will be made according to the symptomatic or non-symptomatic nature of the Chiari malformation. After inclusion, the patients will have a morphological MRI and a PCMRI according to the determined slice plans and allowing a global analysis of the craniospinal hemohydrodynamics. Craniospinal hemohydrodynamics in a control population will also be analyzed using the same methodology by PCMRI.


Eligibility Criteria:
Inclusion Criteria:

* All patients with major symptomatic or nonsymptomatic CMI
* aged 18 to 50 years
* no previous neurosurgical, neurological, or cardiological history.
* Controls should be age-matched to symptomatic CMI group. They should not have a history of neurosurgery, neurology, or cardiology.

Exclusion Criteria:

* Patients who are minors or over 50 years of age
* CMI invalidated by our radiological review
* Neurosurgical, neurological or cardiological history
* MRI contraindication
* pregnant, breast-feeding and parturient women
Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Joined the study voluntarily and signed informed consent form;
* Age 18-75;
* ECOG 0-2;
* Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
* The operative incision healed well;
* T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
* No radiotherapy, chemotherapy or other treatments pre (post) surgery;
* PS ECOG 0-2;
* Life expectancy of more than 3 months;
* Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L;
* Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\< 1.5 x ULN;
* Renal function: creatinine \< 1.5 x ULN
* No immuno-deficiency;
* Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

* Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
* Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
* Participation in other interventional clinical trials within 30 days;
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
* Drug addiction, Alcoholism or AIDS;
* Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
* Unsuitable to be enrolled in the trial in the opinion of the investigators.
Trajectories of Resilience and Bariatric Surgery Outcomes

A high prevalence of psychological trauma on one hand and of psychiatric disorders, such as depression, anxiety, suicide attempts, addictions, and eating disorders on the other hand, has been reported in patients with severe obesity seeking bariatric surgery. Some studies reported an increased prevalence of these psychiatric disorders after bariatric surgery, potentially related to weight regain. In this context, psychological resilience is a concept that brings together internal and external factors of adaptation, and whose clinical use facilitates interdisciplinary collaborative work. This research focuses on the association between resilience and success or failure of bariatric surgery in patients followed in the Specialized Obesity Center (CSO) of the Nancy University Hospital. The hypothesis is that psychological resilience before surgery promotes successful surgical treatment. This retrospective study is based on existing data from patients with severe obesity who have undergone bariatric surgery at the Nancy CSO. The main objective is to study 1) the resilience of patients with severe obesity, candidates for bariatric surgery, at the first assessment (T0), at the end of lifestyle/behavioral modifications program (T1) and at 2 years after bariatric surgery (T2), 2) the relationship between internal and external factors explaining resilience and final weight outcomes.

The investigators are expected that non-resilient patients have more psychological vulnerabilities (psychopathology, negative life events, etc.), and have lower weight loss than resilient patients.

The investigators will report the change of resilience during lifestyle/behavioral modifications program and 2 years after bariatric surgical treatment, and the investigators will describe the factors associated with this change:

* History of trauma
* Psychopathology (eating disorders, depression, anxiety, addiction)
* Personality factors
* Characteristic of psychotherapy

Eligibility Criteria:
Inclusion Criteria:

* Severe obesity (BMI ≥35 kg/m2)
* Candidate for Bariatric surgery at Nancy CSO (2016-2020) after a lifestyle/behavioral modifications program
* Full psychological assessment data

Exclusion Criteria:

* Patient's opposition to the use of data for research purposes
Testing of Mobile Monitoring System

We will complete a prospective, observational study comparing the accuracy of the mobile monitoring tool on identifying SSI compared to manual review.


Eligibility Criteria:
Inclusion Criteria:

* Orthopaedic surgery patient at hospital 175

Exclusion Criteria:

* no access to mobile phone
Gastric Pacemaker Implantation for Gastroparesis

Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.

Due to HUD status, this protocol is for implant only. This is NOT a clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Used only if patients have tried and failed conventional treatment ( drug therapy and dietary modification)due to intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients

The purpose of this study is to evaluate how the investigators provide sedation (medicine that make you sleepy) in the investigators intensive care unit (ICU). This study will look at a new way of using sedation in the ICU to see what effect it has on patients and if it decreases the amount of time spent on mechanical ventilation (machine that breathes for you), and in the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and older
* Patients expected to require mechanical ventilation for greater than 48 hrs

Exclusion Criteria:

* Need for continuous neuromuscular blockade
* Severe chronic neurocognitive dysfunction
* Tracheostomy at the time of study enrollment
* Alcohol withdrawal risk or symptoms
* Drug overdose
* Chronic use of narcotics
* Active seizures
Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination (UroCCR 126)

The project proposes to evaluate the interest of the UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination

Kidney cancer represents 2 to 3% of solid cancers in adults. Worldwide, an estimated 431,288 people a year are diagnosed with kidney cancer. Each year, in France, 13,500 patients undergo total or partial nephrectomy. The development of minimally invasive surgical techniques and the structuring of innovative care pathways for the management of renal tumors in Enhanced Rehabilitation After Surgery (RAAC) and even on an outpatient basis have led to a significant reduction in the length of stays. The physiognomy of the course of care for patients operated on for a renal tumor is completely modified and generates for the patient a feeling of deterioration in the quality of care and disruption of medical follow-up.

The objective is to deploy a model for coordinating the perioperative care pathway of patients who have undergone nephrectomy for renal tumor in several French centers in order to assess the impact for patients, caregivers and the health system.

This coordination would lead to the formalization of a nurse coordinator job profile adapted to the specificities of oncological surgery and the tools necessary for its implementation. The UroConnect device has a "patient" interface for presenting self-questionnaires and access to a library of educational content and a "caregiver" interface to rationalize and optimize the nurse's activity of perioperative coordination in his task.

Eligibility Criteria:
Inclusion Criteria:

* Planned surgical management by total or partial nephrectomy for kidney tumor,
* Affiliation or beneficiary of the French social security
* Expressed consent for integration of the UroCCR cohort,
* Expressed consent to participate in the DiPRU study.

Exclusion Criteria:

* Difficulties understanding and expressing oneself in French
* Participant under guardianship or curatorship
* Pregnancy at the time of surgery
* No internet access
Axial Length With Adult Onset Myopia (ALWAOM)

Purpose: To determine axial length progression and its relationship with myopia onset and progression in adults.

Objectives

1. Determine axial length progression over a two year period of at least 100 subjects/students aged 21 or over (subjects may come from multiple sites). Subjects are to be chosen from optometric education programs beginning in the student's first year.
2. Determine correlation of axial length changes to refractive changes over the two year period.
3. Obtain results of orthokeratology and its effect on axial length and refractive changes.

Methods

1. Measurements of axial length with optical biometry will be taken at yearly intervals for three years and recorded on a spreadsheet (see attached) for future data analysis. Effort will be made to perform measurements at approximately same date each year.
2. Refractive error will be measured using a consistent method such as an autorefractor at yearly intervals for three years and recorded on same spreadsheet as axial length for future data analysis. Effort will be made to perform measurements at approximately same date each year.
3. Subjects that are fit into orthokeratology will be fit with the MOONLENS design (provided by Art Optical at no charge) per normal fitting protocol and followed up with normal protocol Axial length will be measured pre-fitting and at least every year for the three year period. Topography will be captured at pre-fitting and post fitting per normal protocol with images taken at least once per year for three year period. Refraction will also be conducted at least once per year. Axial length and refraction data are to be recorded on same spreadsheet as above and topography saved to a separate folder for future analysis.

Eligibility Criteria:
Inclusion Criteria:

1. 1st year optometry student
2. Refractive error - spherical Component: +2.00D to -5.00D; astigmatic Component: up to -1.50D; non-presbyopic
3. Not currently using any treatment for myopia control, including Orthokeratology lenses, soft multifocal lenses, MiSight lenses, pharmacological interventions, or spectacles for myopia control
4. No significant anterior or posterior segment disease

Exclusion Criteria:

1. Non-graduate student
2. Refractive error outside of: +2.00D to -5.00D; astigmatic Component: up to -1.50D; presbyopic
3. Any participants using treatment for myopia control, including Orthokeratology lenses, soft multifocal lenses, MiSight lenses, pharmacological interventions, or spectacles for myopia control
4. Significant anterior or posterior segment disease
5. Pregnancy
6. Significant systemic disease that may affect refractive error (i.e. diabetes)
Periodontal Changes Following Mid Maxillary Distraction

To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).

Segmental forward maxillary distraction osteogenesis(DO)was performed. Distractor connecting buccal molar segments to the anterior maxilla was kept for 7 days. Then distraction was performed till overcorrection and consolidated for 3-months. Periodontal clinical parameters were recorded at baseline, 3 and 6-months postoperatively. Gingival crevicular fluid was collected . Soft tissue healing was evaluated clinically and histologically after distraction.

Eligibility Criteria:
Inclusion Criteria:

* Severe maxillary hypoplasia and negative anterior overjet

Exclusion Criteria:

* Systemic disease
Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)

This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).

This is a phase II, double-blinded, placebo-controlled study to investigate the safety, efficacy, and pharmacokinetic profile of two doses of EPA-E in adult subjects with NASH. Subjects are required to have a liver biopsy with proven NASH in the 6 month period prior to screening. Up to 70 subjects will be enrolled into each treatment arm in a 1:1:1 ratio, for a total of 210 subjects. Subjects will be stratified at randomization by presence or absence of diabetes. Duration of treatment is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definite NASH
* Patients with diabetes taking stable doses of anti-diabetic agents are eligible
* No significant concomitant medical illness

Exclusion Criteria:

* Diagnosis of cirrhosis.
* Serum ALT \> 300 U/L
* Use of drugs associated with steatohepatitis
* Use of the following anit-NASH agents:

  1. Vitamin E \> 60 IU per day
  2. Omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements \> 200 mg per day
  3. Thiazolidinediones (e.g. pioglitazone)
* Use of non-stable doses of the following anti-NASH agents: HMGCoA reductase inhibitors (statins), fibrates, probucol, ezetimibe, ursodiol (UDCA), taurine, betaine, N-acetylcysteine, s-adenosylmethionine (SAM-E), milk thistle, anti-TNF therapies, or probiotics.
* Other liver disease
A Study to Evaluate the Safety and Efficacy of Caelyx in Combination With Carboplatin in Patients With Ovarian Cancer Recurrent Within Six to Twelve Months After Initial Carboplatin and Paclitaxel Chemotherapy (P03625)

Doxorubicin has been used to treat ovarian cancer as part of different combination therapies, but high cumulative doses should be avoided because of the risk of cardiotoxicity. Pegylated Liposomal Doxorubicin (Caelyx) has been developed to reduce the risk of cardiotoxicity. The purpose of this study is to evaluate the safety and efficacy of Caelyx in combination with carboplatin in women with recurrent ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years old
* Subject must have histological diagnosis of epithelial ovarian cancer
* Subject must have received a taxane and platinum regimen and have maintained a treatment-free status for at least six months and not more than twelve months following completion of first line therapy.
* Subject must have measurable ovarian cancer by appropriate radiological imaging.
* ECOG performance Score of 0 or 1.
* Subject's life expectancy must be \> 6 months.
* Subject must have normal organ function, except if abnormal due to tumor involvement:

  * Adequate bone marrow function (platelets \>=100 X 10\^9/L, hemoglobin \>=100 g/L, neutrophils \>=1.5 X 10\^9/L)
  * Adequate renal function (serum creatinine\<=1.5 X the upper limit of normal (ULN)
  * Adequate liver function (bilirubin and AST or ALT\<=2 times ULN, unless related to primary disease.
* MUGA scan must indicate left ventricular ejection fraction above 90%.
* Women of childbearing potential must be using adequate contraception (prescribed under medical supervision) and have a negative pregnancy test at the time of enrollment.
* Subject must be able to sign written informed consent.

Exclusion Criteria:

* Subject who is pregnant or is breast feeding.
* Subject who has history of cardiac disease, with New York Heart Association Class II or greater.
* Subject with a history of severe hypersensitivity reactions to products containing Cremophor® EL.
* Subject with clinically significant hepatic disease.
* Subject who has uncontrolled bacterial, viral, or fungal infection.
* Subject who exhibits confusion or disorientation.
* Subject with any condition that would prevent adequate follow-up.
* Subject with a history of prior malignancy treated with systemic chemotherapy or radiotherapy.
* Subject who has received two or more prior chemotherapy regimens for ovarian cancer.
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.

Participants will:

* Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months.
* Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.


Eligibility Criteria:
Key Inclusion Criteria:

* Presence of at least one large druse \>125 microns in diameter due to AMD.
* BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 \[20/40 to 20/200\])

Key Exclusion Criteria:

* Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker.
* Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck).
* Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) \>10% (13.3 mmol/L).
* Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day).
* Known severe allergy to fluorescein dye.
* Medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, or Cequa).
* History of seizure disorders, chronic migraines and/or cluster headaches.
* History and/or evidence of diabetic retinopathy in either eye as assessed by CF, fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central Reading Centre.
* Other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., Stargardt's disease, Best's disease, pattern dystrophy, central areolar choroidal dystrophy, etc.).
* History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (or OCT-A ), and OCT, to be confirmed by Central Reading Centre.
* GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT.
* History of intravitreal injections for GA (e.g., Syfovre or Izervay).
* Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening.
* Glaucoma requiring ≥3 medications and/or drops per day, or history of trabeculectomy.
* History of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from Screening.
* History of yttrium aluminium garnet (YAG) laser posterior capsulotomy \<1 month from Screening.
* Visually significant cataracts and/or visually significant posterior capsular opacification.
* History of amblyopia.
The Effect of Non-invasive Auricular Acupoint Stimulation on Slow Transmission Constipation

Objective To examine the therapeutic effect and safety of non-invasive auricular acupoint stimulation application on patients with slow transmission constipation.

Methods In a randomized clinical trial, 60 patients diagnosed with slow transit constipation (STC), ranging in age from 40 to 75 years, were allocated into two distinct cohorts: a study group and a control group. The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride, while the control group, also consisting of 30 patients, was administered prucapride as a monotherapy. To assess the efficacy of the interventions, various parameters were monitored, including serum levels of Neuropeptide Y (NPY), nitric oxide (NO), fecal water content, and gastrointestinal (GI) transit. The comparative therapeutic outcomes were determined by calculating symptom scores.


Eligibility Criteria:
Inclusion Criteria: ① Conformity to the diagnostic benchmarks for STC as delineated in the Rome IV criteria; ② Absence of ingestion of any medication influencing gastrointestinal motility within the preceding three months; ③ Provision of informed consent after a comprehensive understanding of the study's objectives; ④ An age range of 40 to 75 years.

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Exclusion Criteria: ① Withdrawal from the therapeutic regimen; ② Auricle or ear canal pathologies; ③ Organic defecation disorder; ④ Pregnant or lactating.

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Aspirin Responsiveness in Women at Risk for Cardiac Events

The objective of this pilot study is to evaluate the prevalence of biological aspirin resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then re-tested for aspirin responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* Women at least 19 years old
* Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary prevention of cardiovascular disease.
* Able and willing to provide informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Known CHD
* Currently taking clopidogrel or ticlopidine
* Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours
* Allergy or hypersensitivity to salicylates
* Use of other OTC or prescription analgesics or anti-inflammatory medication in the past two weeks
* Currently participating in another investigational drug or device study