cyrilzakka/clinical-trials huggingface dataset:
Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.

The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.

Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.


Eligibility Criteria:
Inclusion Criteria:

* Patient lived in t Loire (42) or Haute-Loire (43)
* Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
* French writing and speaking
* Sedentary or low level of activity (less than 2 hours of regular physical activity per week at the time of inclusion)
* Signature of informed consent

Exclusion Criteria:

* Cardiac or respiratory diseases that contraindicate the practice of physical activity
* Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
* Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason
Mucosal Impedance in Pediatric Population

Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower esophageal impedance measurements when compared to patients who do not have GERD or EE.

The overall goal of this project is to develop and assess a novel, inexpensive, minimally invasive technology to detect mucosal damage based on mucosal conductivity changes in the pediatric population. The study is based on preliminary work between Sandhill Scientific, Inc. and our adult gastroenterology department. They have collaborated to create a novel, minimally invasive Mucosal Impedance (MI) test (proprietary technology) based on animal studies which have shown esophageal tissue exposed to acidic and weakly acidic injurious agents causes dilation of intercellular spaces and loss of tight junctions along the squamous epithelial lining of the esophagus and results in measurable decreased baseline impedance.9 Adult studies have confirmed the correlation between decreased impedance and diseased tissue, however this has not been studied in children. We hypothesize that pediatric patients with histologic damage seen in GERD and EoE will have mucosal changes resulting in decreased electrical impedance compared to those with normal histology. We propose that this technology will accurately and reliably measure the mucosal consequence of chronic esophageal exposure to injurious gastroduodenal agents or food allergens. Thus, this test would serve as a minimally invasive screening tool for GERD and EoE prior to endoscopy, and allow longitudinal monitoring of mucosal response to therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 1 year and 18 years of age
* Patients who are undergoing standard of care upper endoscopy and biopsy for complaints of dyspepsia

Exclusion Criteria:

* Families unable to give informed consent/assent;
* Patients with other active comorbid conditions including cardiac disease, pulmonary disease (excluding asthma), significant motility conditions
Echocardiographic Screening of Pregnant Women During Antenatal Care

Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings.

Pregnant women presenting to B.P. Koirala Institute of Health Sciences will be prospectively included into a registry upon their visit for antenatal care. Women will be followed until 6 weeks after the time of delivery. Nested within this registry, the investigators will perform a registry-based adaptive cluster randomized crossover trial. The trial compares an experimental condition (echocardiographic screening) and a control condition (routine antenatal care).

Latent structural heart disease may result in complications during pregnancy and delivery. Echocardiographic screening of pregnant women allows for timely detection of structural heart disease in women that may complicate delivery and jeopardize the health and well-being of both the mother and the newborn. In a setting of high rates of latent rheumatic heart disease, with particular high prevalence among women, systematic echocardiographic screening may be a pragmatic approach to prevent adverse clinical outcome related to valvular heart failure. Systematic echocardiographic screening proved to be effective among children in endemic regions.

The present study is a registry-based, adaptive cluster randomized crossover trial. The trial will be nested into a registry of pregnant women presenting for routine antenatal care. The experimental condition will be echocardiographic screening. The control condition will be no echocardiographic screening.

In the experimental condition, all pregnant women presenting for routine antenatal care will be offered transthoracic echocardiographic screening for the detection of latent structural heart disease. In the control condition, pregnant women will undergo routine antenatal care with echocardiography only when clinically indicated. Ascertainment of the primary endpoint will be performed at hospital discharge after delivery and will rely on routinely collected data. All events will be independently adjudicated by an expert panel of pediatricians, cardiologists and gynecologists.

The randomization relates solely to the detection of rheumatic heart disease, while treatment follows guideline recommendations. It is important to note, that all women both in the experimental arm and the control arm detected to have heart disease will undergo optimal medical management during pregnancy and delivery according to the most recent guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ≥18 years presenting for routine antenatal care.
* Written informed consent.

Exclusion Criteria:

* Women presenting to the hospital after delivery.
* Women presenting directly for delivery without previous antenatal care.
Elastography in Thyroid Nodules

Thyroid nodules are a common finding in the general population,however, they are mostly unpalpable and usually discovered either during neck ultrasound (US) examination or by pathological examination at autopsy. They are found in about 8% of adults. Most thyroid nodules ''incidentalomas" are benign, however 7% may be malignant. Early detection of thyroid cancer helps in early treatment and better survival US is an accurate method for detection of thyroid nodules; however, US has a low accuracy in differentiating between benign from malignant thyroid nodules . US could suggest a malignancy likelihood criteria of a thyroid nodule, such as hypoechogenicity, increased intranodular vascularity, irregular margins, microcalcifications, absent halo, and a taller-than-wide shape measured in the transverse dimension.

US elastography has been used to detect the nature of thyroid nodules, by measuring the tissue stiffness non invasively. It depends on tissue deformation strain that is caused by external compression.it is complementary to gray scale findings particularly in nodules with indeterminate US findings, also US elastography could be used to guide the follow up of leisons diagnosed as benign at ( FNA) fine needle aspiration .

There are two main thyroid elastography methods in clinical practice: strain elastography (SE) and shear-wave elastography (SWE) .

Elastography methods can be classified into different variants based on the excitation method (external force, internal force, and acoustic radiation force \[ARF\]), and how stiffness is expressed . (A) strain elastography . SE reqires mechanical stress, which results in axial displacement of the tissue Tissue deformation from the stress is measured and visualized on a screen. The main limitations of SE are operator dependence for the angle, strength, and duration of compression.

(B) shear wave elastography . The acoustic pulses from the probe stimulate the target tissue, creating a shear wave (SW) traveling perpendicular to the conventional US waves. SWs are the transverse components of particle displacement that are rapidly attenuated by the tissue (1- 10 m/sec). This transverse component is tracked and measured as a numerical value corresponding to the shear-wave speed (SWS).This speed is closely related to the Young modulus formula, in which tissue elasticity can be assessed from the SW propagation.

US elastography is completely painless for the patient, and only requires a few extra minutes, with no separate patient preparation. US elastography has the potential to distinguish benign from malignant TNs, offering non-invasive complementary information to conventional US.

It may be particularly useful in patients who have nondiagnostic or indeterminate FNA cytology results.

Eligibility Criteria:
Inclusion Criteria:

* solitary nodule on clinical or ultrasound examination

Exclusion Criteria:

* Patients received any medical treatment or chemo or radiotherapy.
* Patients underwent fine needle aspiration cytology or biopsy
* Nodules with calcification and cystic changes
Evaluation of Smile Esthetics in Orthodontically Treated Patients With Bimaxillary-dentoalveolar Protrusion

Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients with Bimaxillary-dentoalveolar Protrusion.

A Retrospective Cohort Study.


Eligibility Criteria:
The selected records should meet the following inclusion criteria:

Pre treatment:

1. Full permanent dentition
2. No dental nor any craniofacial anomalies
3. Molar Class I with bimaxillary-dentoalveolar protrusion
4. No excessive over jet or overbite

Treatment mechanics:

1. All patients treated with extraction of four 1st premolars
2. Retraction of anterior teeth using maximum anchorage mechanics

Post treatment:

1. Canine 1 relation
2. Molar I relation

Exclusion criteria :

Any orthodontic records without the previously mentioned pre and posttreatment inclusion criteria
YKL-40 and IL-6 Levels in Periodontal Disease

The primer aim of the study was to investigate saliva and gingival crevicular fluid (GCF) YKL-40 and also interleukin-6 (IL-6) levels in chronic periodontitis pathogenesis.

This study consisted of two groups: 26 periodontally healthy individuals and 26 generalized chronic periodontitis patients. Chronic periodontitis patients were received nonsurgical periodontal treatment. Clinical measurements were recorded, saliva and GCF samples were obtained before and at first and third months after periodontal therapy. Levels of YKL-40 and IL-6 in saliva and GCF were analyzed by enzyme-linked immunosorbent assay.

Eligibility Criteria:
Inclusion Criteria:

Group 1 Inclusion Criteria:

* No bone and attachment loss,
* GI=0, PPD≤3mm, CAL≤3mm
* Systematically healthy patients

Group 2 Inclusion Criteria:

* GI\>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
* Systematically healthy patients

Exclusion Criteria:

* Aggressive Periodontitis,
* Patients with any other systemic diseases,
* Pregnant women and those in the lactation period,
* Patients with smoking habit and taking medication
* Patients received periodontal therapy in last 6 month
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy

This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.


Eligibility Criteria:
Inclusion Criteria:

* Kidney or liver transplanted patients
* Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events

Exclusion Criteria:

* Recent graft rejection before the study
* Other pre-existing conditions that may cause gastro-intestinal complaints
* Use of other drugs known to cause gastro-intestinal complaints

Other protocol-defined inclusion/exclusion criteria may apply
China STEMI Care Project

The China ST-elevation myocardial infarction (STEMI) Care Project (CSCAP) aims to improve the reperfusion treatment rate and shorten the total duration of myocardial ischemia by establishing a regional STEMI treatment network covering the whole-city region, whole-city population, and whole-disease process step by step. The CSCAP is a prospective, multicenter registry involving three phases. A total of 18 provinces, 4 municipalities, and 2 autonomous regions in China were included. Patients with STEMI who met with the third acute myocardial infarction definition and the Chinese STEMI diagnosis and treatment guidelines were enrolled and the estimated number is over 50,000. Phase 1 (CSCAP-1) focused on the in-hospital process optimization of primary percutaneous coronary intervention (PPCI) hospitals. Phase 2 (CSCAP-2) focused on the PPCI hospital-based regional STEMI transfer network, including emergency medical services and non-PPCI hospitals. Phase 3 (CSCAP-3) focused on the whole-city STEMI care network construction by promoting chest pain center accreditation. Systematic data collection, assessment of quality of care, and subsequent improvement were implemented throughout the project to continuously improve the quality of care for patients with STEMI.

CSCAP is the first project that focused on establishing a regional STEMI emergency care network in China to help understand the condition of STEMI care in China extensively. Moreover, its objective was to optimize the quality of STEMI care through in-hospital process optimization (2012-2013), PPCI hospital-based regional STEMI transfer network construction (2015-2018), and construction of the whole-city STEMI care network step by step (2018-2021). However, hospitals were not randomly selected in CSCAP, which might be because of the lack of representatives to some degree. Alternatively, it focused on providing a tailored quality-of-care improvement plan based on the conditions of different regions.


Eligibility Criteria:
Inclusion Criteria:

* STEMI patients

Exclusion Criteria:

* None
Biomarkers for Acute Graft-versus-host Disease

Validation of already described biomarkers on acute GVHD prediction and severity Fecal calprotectin and alpha 1 anti-trypsin, plasmatic RER3a, IL-8, Elafin, TNFaR1, IL-2R alpha, HGF

Description of the project: The main objective of this prospective biological single center study (non interventional) is to identify non invasive biomarkers able to diagnose acute GVHD and/or predict outcome of patients with acute GVHD. The primary objective of the study is double: (1): to evaluate markers as diagnostic markers of GVHD (2): to evaluate the potential of the markers as risk factor for steroid-refractory acute GVHD occurrence. Secondary objectives are: -to evaluate the markers as risk factors for GVHD -to evaluate the potential of these markers as prognostic factors of 6-month non-relapse mortality in patients with acute GVHD-to evaluate the additional value of the biomarkers to predict GVHD or steroid-refractory GVHD as compared to other known and routinely used risk factors (clinical grading system, performance status, albuminemia...). Stools and blood will be on day 7, 14, 21, 28 after transplantation and the first day of digestive GVHD. Management of patients will not differ from the usual care. Fecal calprotectin and alpha 1 anti-trypsin, plasmatic RER3a, IL-8, Elafin, TNFaR1, IL-2R alpha, HGF will be measured at each points by ELISA tests. 315 patients would be sufficient to estimate the area under the ROC curve with a half-width of the 99% confidence interval of 0.05, assuming 60% of patients would develop acute GVHD, and normally distributed markers. The diagnosis and prognosis values will be analyzed separately.

Expected results: If some biomarkers are found significantly associated with diagnosis or prognosis of acute GVHD, they will be compared with the current clinical, biological and histological markers. Indeed, these markers have a clinical potential impact only if they give similar or better information than routine currently available markers, ie: clinical GVHD grading system, performance status, gut endoscopy and histology. The non-invasivity of these biomarkers should also be taken into account (in comparison to histology).

Identification of diagnostic markers will avoid useless treatment with high dose corticosteroids in patients without GVHD Identification of prognostic markers will comfort the decision of a second-line treatment sooner than usually, ie: at GVHD onset. Indeed, the onset of a second-line treatment after a steroid-refractory GVHD varies from 3 to 21 days depending on clinical evolution of patients. If some prognostic markers are available at diagnosis, delay in second-line treatment can be shortened and the patient can consequently have an increased chance to response to an early treatment.

Identification of prognostic markers will also guide the corticosteroids decrease in patients with good prognosis GVHD

Eligibility Criteria:
Inclusion Criteria:

* adult patients receiving an allogeneic transplant
* informed consent signed

Exclusion Criteria:

* patient refusal
ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults

Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups.

Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups, to provide a more scientific medication scheme for sedation in Drug-induced Sleep Endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18-65 years old, 2. ASA Ⅰ-Ⅲ level; 3. Sign an informed consent form.

Exclusion Criteria:

* 1.A history of central nervous system diseases, cognitive disorders, mental disorders, or communication disorders; 2.serious cardiovascular, respiratory, liver or kidney disease; 3.Anticipated need for tracheal intubation or laryngeal mask; 4.Allergic to benzodiazepines and opioids; 5.Those who have taken sedative, analgesic or antidepressant drugs within 24 hours; 6.Abnormal liver and kidney function; 7.Recently participated in other clinical studies.
5-SENSE Score Validation Study

The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 15 years or older in whom no direct surgical approach can be offered and who are discussed in the multidisciplinary team discussion
* availability of complete non-invasive presurgical work-up (including high-resolution MRI according to the in-center epilepsy protocol, video-telemetry with the recording of a minimum of one habitual clinic and EEG seizure, available as original files for review)

Exclusion Criteria:

* no telemetry/scalp EEG in center
* no protocol MRI in center
* subdural/GRID electrodes
Offset of Ticagrelor's Effect on Endothelial Function as Assessed With Peripheral Arterial Tonometry (EndoPAT Assay)

Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown that ticagrelor increases adenosine concentration, by interfering with its red blood cells' uptake and by inducing the release of ATP which is then converted to adenosine. Recent studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that ticagrelor increases the coronary blood flow in response to intravenous adenosine administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating endothelial dysfunction and has been found to positively correlate with flow mediated dilatation (FMD).

This is a prospective, observational study, which will be conducted in patients with coronary artery disease subjected to percutaneous coronary intervention (PCI) under ticagrelor maintenance dose (MD) 90mg x 2, who are about to stop treatment, due to completion of 1 year antiplatelet therapy. Eligible patients will be subjected to peripheral arterial tonometry at Day 0 (immediately after receiving the last pill of ticagrelor) and at day 2 and day 5 post study drug discontinuation. Peripheral blood sample will be taken from the patients at Day 0 for genotype analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Age above 18-80 years old
2. Patients with Coronary Artery Disease receiving ticagrelor maintenance dose (MD) 90mg x 2 and are about to discontinue the treatment due to the completion of 1 year of dual antiplatelet therapy.
3. Patients giving written Informed Consent.

Exclusion Criteria:

1. Acute Coronary Syndrome
2. Foreseeable need for anticoagulant treatment within the next 5 days
3. Severe non-regulated with theophylline/aminophylline administration chronic obstructive pulmonary disease
4. Creatinine Clearance \<30ml/min/1.73mm2
5. HbA1c \> 10mg/dl
Transcranial Direct Current Stimulation (tDCS) as an add-on Therapy for Treatment of Major Depressive Disorder. (DEPTDCS2014)

The aim is to investigate the safety and effectiveness of transcranial Direct Current Stimulation (tDCS) in patients with moderate to severe major depression compared to patients treated with conventional therapy. The tDCS will be used as add-on to conventional therapy.

This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients.


Eligibility Criteria:
Inclusion Criteria:

* Fulfils the ICD-10 diagnostic criteria for moderate or severe major depressive episode (F32), or recurrent major depressive episode (F33)
* Able to understand the purpose and potential risks of the study
* Able to sign informed consent

Exclusion Criteria:

* intracranial metal implants or other foreign intracranial metal object
* history of neurological conditions e.g. epilepsy, stroke (ischemic or haemorrhagic); brain tumor; increased intracranial pressure etc.
* schizophrenia
* bipolar disorder
* psychotic disorder
* substance abuse or dependency
* contra-indications to tDCS
* personality disorder that may prevent him/her to commit to the study
* skin lesion in the area of stimulation
* planned treatment of current depressive episode with ECT or rTMS