cyrilzakka/clinical-trials huggingface dataset:
The Immune Reactivity of Biofilms in Vaginal Mesh Erosion.

Aging, birth trauma and extensive pelvic surgery are the causes known to cause advanced pelvic organ prolaspe, fecal as well as urinary incontinence. Surgical treatment is the last resort to manage the above-mentioned clinical manifestations of pelvic floor disorders except the subject is too frail to receive operation.

In order to improve the outcome of reconstructive pelvic surgery, reinforcement with synthetic mesh or biological material is the modern trend in pelvic repair. Unfortunately no prosthesis including synthetic or biological is ideal because vaginal erosion with mesh extrusion which is the subject of this protocol and other complications were reported continuously. As per the literature, the rate for mesh vaginal extrusion ranged between 2.4 and 17% when polypropylene which is the most popular synthetic material used for the mid-urethral sling or pelvic reconstructive surgery to date. The causes of this complication are still controversial which include rejection, poor quality of tissue, surgical artifact, material of mesh and etc.

A prospective controlled study for the investigation of the cause for mesh vaginal erosion was conducted and the results revealed evidences of immune reactivity after mesh implantation, albeit the evidence was not solid (Am J Obstet Gynecol 2004; 191(6): 1868-1874 ). As per the pilot study initially done by us to determine the biofilm-related-infection, we have found bacterial biofilm could adhere to surfaces and interfaces, i.e. bacteria located in the cells just beneath the contacting surfaces in the electron microscopic (EM) analysis. In addition, soon after bacteria infection, proteins in biofilm undergo conformational changes, making them immunogenic and triggers a typical inflammatory response leading to activation of the complement system. Thus, we plan to use CD (clusters of differentiation) antigens - 4, 8, 20, 25, 40, 68 and quantitative analysis of FoxP3 to determine the function of regulatory T cells in the immune response. In addition, bacterial culture and EM analysis of the excised mesh with surrounding vagina tissue will be performed for further analysis of biofilms.


Eligibility Criteria:
Inclusion Criteria:

* Study arm: Subjects present with mesh erosion in vaginal after placement of polypropylene mesh for either urinary stress incontinence or pelvic organ prolapse.
* Control arm: Subjects present with symptomatic vaginal prolapse but without mesh erosion after placement of polypropylene mesh for either urinary stress incontinence or pelvic organ prolapse.

Exclusion Criteria:

* Study arm: The eligible subjects with fasting sugar level ≥ 180mg/dL, post prandial sugar level ≥ 230mg/dL.
* Control arm: Polypropylene mesh placement less than 6 months.
Identification of Microplastics in Liver, Stomach, Blood, and Feces of Obese Patients and Their Association Analysis with Macrogenomics and Metabolomics.

The aim of this study was to identify and quantify microplastics in the stomach, liver, feces, and blood of obese patients to be treated with bariatric surgery by using a variety of advanced analytical techniques to explore the association between obesity and visceral microplastics, and to investigate the effects of microplastics on the visceral microbiota and metabolic profiles of obese patients by combining the macro-genomic and metabolomics approaches.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* BMI ≧30;
* proposed to undergo bariatric surgery and need to remove part of the liver tissue for fatty liver test;
* complete clinical data and basic information;
* willing to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Receive chemotherapy, radiotherapy, immunotherapy;
* have other history of digestive diseases;
* combined with malignant tumors;
* have serious cardiorespiratory insufficiency and other systemic diseases that affect the choice of treatment plan;
* not willing to participate in this study.
Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie)

First, investigators must determine the physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness \[VD\] and left ventricular \[LV\]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups \[0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years\]).

Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with cardiomyopathy and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. The total population of the study will be 120 children (40 healthy, 80 patients).

Monocenter Prospective, open-label, non-randomized. All patients included in the study have a specific consultation built around a clinical examination and echocardiography, in two stages, with estimates of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measures of all echocardiographic parameters estimated in children with a clinical ultrasound machine (Philips and General Electric).

Following this consultation, clinic and electrocardiographic monitoring period will be observed for 30 minutes, to ensure the safety of our procedure.

Required subjects: 40 healthy volunteers + 80 = 120 persons

Eligibility Criteria:
Inclusion Criteria:

Group 1. Healthy Age criteria met by group \[0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years\]

* consultation for heart murmur
* Recipient of a social protection scheme or entitled (excluding AME)
* Signed informed consent by the holders of parental authority

Group 2. Patients MHC nonobstructive:

* Age criteria met by group \[1 month-1 year 1 year-5 years\]
* Diagnostic criteria of non-obstructive HCM validated by the medical team of pediatric cardiology center (Necker)
* Recipient of a social protection scheme or entitled (excluding AME)
* Signed informed consent by the holders of parental authority

Group 3. Patients primitive CMD:

* Age criteria met by group \[1 month-1 year 1 year-5 years\]
* Diagnostic criteria of primary CMD validated by the medical team of pediatric cardiology center (Necker)
* Recipient of a social protection scheme or entitled (excluding AME)
* Signed informed consent

Exclusion Criteria:

Group 1. Healthy Patients:

* Age\> 15 years
* Heart and Systemic Pathology identified
* metabolic and tissue pathology.
* known genetic pathology may have cardiac involvement.
* No echogenicity,
* Allergy echocardiography gel.

Group 2. Group CMH primitive Patients

* No echogenicity,,
* Allergy echocardiography gel.
* Arrhythmia.
* Pacemaker or defibrillator

Group 3. Patients primitive CMD:

* No echogenicity,,
* Allergy echocardiography gel.
* Arrhythmia.
* Pacemaker or defibrillator
Basal Plus GLP1-ra on Glycemic Variability in CKD

To compare GLP-1 RA plus basal insulin (BGLP) versus basal-bolus (BB) insulin regimens on glycemic variability (GV) and time in range (TIR) in diabetes patients CKD stage 3-4


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus diagnosed for at least 6 months
2. Male or female age ≥ 18 years old and ≤ 75 years old.
3. Body mass index between 18 and 40 kg/m2 inclusive
4. HbA1c ≥ 6.5% and ≤ 9.0% at screening
5. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
6. Patients with CKD stage 3 or 4 as defined by estimated glomerular filtration rate between 15-59 ml/min/m2 by the modified Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening
7. Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) and use of pre-specified glucose monitoring devices.
8. In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
9. Written informed consent to participate in the study provided by the patient.
10. Willing and capable of use of a continuous glucose monitor as judged by the investigator

Exclusion Criteria:

1. Type 1 diabetes
2. Currently pregnant, as demonstrated by a positive pregnancy test at screening or planning pregnancy
3. Treatment with GLP-1 RA or insulin degludec in the past three months
4. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
5. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
6. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
7. Extensive skin changes/diseases that preclude wearing the CGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
8. Have a known allergy to medical-grade adhesives
9. Known current or recent alcohol or drug abuse
10. Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction in the six months prior to screening
11. Patients on renal replacement therapy or likely require kidney transplant or dialysis during the study period
12. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
13. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
Apathy in Parkinson Disease: Clinical, Physiopathological and Pharmacological Study

Apathy has been reported to occur after subthalamic nucleus stimulation (STN-DBS), a treatment of motor complications in advanced Parkinson's disease (PD). It is not known whether postoperative apathy is related to dopamine withdrawal or a side effect of STN DBS. The researchers investigated potential predictors of apathy, and the effect of dopamine agonist treatment.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease

Exclusion Criteria:

* Mattis scale \< 130
* Beck scale \> 20
Analysis of in Vitro Biological Reaction of Diaphragmatic Prothesis When Congenital Diaphragmatic Hernia (CDH) Repair

In case of CDH, the incomplete development of a part of the diaphragm allows abdominal viscera to herniate into thorax cavity during fetal development and impaired lung and heart development.

After birth, CDH patients who survived thanks to an active reanimation management undergo diaphragmatic repair. In case of large defect, a patch is needed to complete diaphragmatic closure. Thanks to primary cell culture from foreskin, peritoneal epithelium or cremaster dedicated to incineration investigators want to analyse biological integration of actually used prothesis and others innovations.


Eligibility Criteria:
Inclusion Criteria:

* Minor aged 0 (day of birth) to 14 years
* Patient for whom an indication of posthectomy and / or cure of inguinal hernia and / or testicular ectopy is retained
* Patient whose legal representatives have agreed to the use of operational waste from mesenchymal tissues (foreskin, cremaster and peritoneum) destined for incineration.
* Patient affiliated to a social security scheme

Exclusion Criteria:

- parents don't agree to the use of its operating waste for research purposes
Intermetatarsal Bursitis in Patients with Rheumatoid Arthritis

The aim of the study is to investigate the incidence and clinical implications of intermetatarsal bursitis (IMB) in patients with rheumatoid arthritis (RA).

The hypothesis is that IMB is a cause of pain in patients with RA.

Within the recent years more research have focused on IMB in patients with rheumatologic disorders. There is emerging evidence that IMB is an inflammatory alteration in line with synovitis in patients with RA, and presence of IMB have been linked to the early stages of RA, especially due to the focus of the published literature.

The clinical implications of the presence of IMB for the patients are yet to be understood. Limited studies have linked the occurrence of IMB to foot impairment, but no studies have been conducted investigating the direct association between forefoot pain and the presence/absence of IMB.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Forefoot pain and diagnosed with RA (patient group)
* Diagnosed with an axial arthritis (control group)

Exclusion Criteria:

* Age \<18 years
* Open wounds or ongoing infection in the forefoot at the time of examination
* Persons with a history of significant trauma in the forefoot, e.g. any fracture or previous surgeries in the forefoot
* Persons who have previously received intermetatarsal treatment (Morton's neuroma or IMB) in the same foot, e.g. injection within 6 months or operation at any time
* Exclusion from MRI scan only:
* Persons with contraindications to participate in MRI scan
* Persons with severely impaired renal function (GFR \<30 ml/min)
Curcumin and Nanocurcumin in Oral Aphthous Ulcer

Recurrent aphthous ulcer is a painful inflammatory lesion with a high prevalence. Since the etiology is not clear, several strategies have been proposed to reduce pain and severity of its symptoms. Today, curcumin is considered as an herbal medicine with anti-inflammatory properties. Treatment or control of various inflammatory diseases has been proposed, but its low solubility in water has reduced bioavailability, while the use of nanoparticle pharmaceutical techniques has been able to solve these problems. Therefore, the aim of the present study was to evaluate the clinical efficacy of a new topical curcumin gel with nano-technology and compare it with 2% curcumin gel in patients with recurrent aphthous ulcers.

This randomized clinical trial was performed on 48 patients assigned to two groups (nano-curcumin gel) and (curcumin gel). Before treatment, the size of the wound and VAS were measured. After intervention, the two variables were measured again on the fourth and seventh days , then the amount of improvement was quantitatively and qualitatively compared in the two groups and a significant level of less than 0.05 was considered.


Eligibility Criteria:
Inclusion Criteria:

* Patients with minor and recurrent aphthous ulcer lesions within 48 hours and Aphthous like Lesions

Exclusion Criteria:

* Wounds are in inaccessible areas (such as posterior palate). If a person suffers from systemic disease (through questioning the patient) Patients with turmeric allergy and any type of gel used in this study. Pregnant or lactating women .. accompany with other mucosal lesions. Do not take any other medicine while taking intervention Major or herpeti form of aphthous ulcer
High Dose Bupropion for Smoking Cessation - Pilot Study

This study aims to investigate the benefit of administering two differing doses of Bupropion (BUP) to smokers to assist with smoking cessation.

Participants will be randomly assigned to either receive 300 mg of BUP or 450 mg of BUP for 8 weeks with an aim to quit smoking. In addition, participants will simultaneously receive counseling to set a quit date and stay motivated to quit. Medication will be administered up to 4 weeks before and for 4 weeks after designated quit-date. Post-treatment follow-up appointment will be scheduled for 8, 16, and 26 weeks post treatment to assess commitment to quitting and overall success of the study.

Eligibility Criteria:
Inclusion Criteria:

* Smokes cigarettes daily for at least 1 year
* Breath CO of 5 ppm or higher at Baseline visit
* Age 21 - 65

Exclusion Criteria:

* Possible drug contraindications (panic disorder, bipolar disorder, bulimia, anorexia, insomnia, suicidal ideation, alcohol withdrawal, seizures, severe hypertension, renal/hepatic impairment, angle closure glaucoma)
* Unstable cardiovascular disorder or uncontrolled hypertension
* Severe renal/hepatic impairment based on serology evaluation
* History of seizures, liver failure, central nervous system tumor, central nervous system infection, hypoglycemia, hyponatremia, hypoxia, stroke arteriovenous malformation, head injury
* Current use of other cessation medication or counseling
* History of bupropion use
* Current anti-psychotic, anxiolytic, antidepressant, or psychostimulant medication use, other drugs that may lower seizure threshold, CYP2B6 inhibitors, CYP2B6 inducers, drug metabolized by CYP2D6
* Sudden stoppage of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs
* Current (past 30 days) use of illicit or medical use of prescription stimulants
* Currently or plan to be pregnant or breastfeeding
Is There a Relationship Between Hyperlipidemia and Periodontitis?

The aim of present study is to investigate any relationship between hyperlipidemia and periodontal disease regarding the periodontal parameters and plasma lipid parameters, along with age, gender, brushing habit, body mass index, dietary habit, physical activity, alcohol consumption.

In this cross sectional study, a total of 160 individuals were divided into two groups based on their metabolic status: hyperlipidemic group (n=97) and normolipidemic group (n=63). Plaque index, gingival index, bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL) clinical parameters and community periodontal index of treatment needs (CPITN) scores were measured. Triglyceride (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C) levels had been determined previously during individuals routine systemic examinations. Daily brushing habits and interdental cleaning together with dietary habits, alcohol consumption and physical activity levels were also recorded.


Eligibility Criteria:
Inclusion Criteria:

* Subjects having no periodontal treatment within previous 6 months,
* number of natural teeth ≥ 10,
* no history of cancer and systemic disease that affects lipid levels or periodontium,
* no history of medical treatment for hyperlipidemia, BMI\< 30 kg/m2,
* no pregnancy,
* no history of systemic antibiotic treatment within previous 3 months,
* no smoking.

Exclusion Criteria:

* patients with history of systemic disease that affects lipid metabolism or periodontal disease
* history of medical treatment for hyperlipidemia
* pregnancy, lactation or hormone replacement therapy at the time of study
* use of any other drug known to affect lipid metabolism or periodontal disease
* systemic infection or any history of systemic antibiotic treatment in previous 3 months
* smokers as well as ex-smokers
Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission

The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who received mesalazine.

Crohn's disease is characterized by inflammation and ulceration of the small intestine and colon. Patients commonly experience abdominal pain, diarrhea，malnutrition and malaise which result in decreased quality of life and an increased risk of chronic disability and unemployment.

Tripterygium Glycosides(T2) is a chloroform/methanol extract Tripterygium wilfordii Hook F (TWHF), the traditional Chinese medicine, used in rheumatoid arthritis and nephritis. It has both immune-modulatory and anti-inflammatory activities. Our previous animal studies have revealed that the major component of T2, triptolide, could prevent the development of chronic colitis in interleukin-10 deficient mice. The phase I clinical trial in our institute also demonstrated that T2 is efficient for induction of remission in patients with mild to moderate active crohn's disease. The common adverse effects of T2 are leucopenia, liver renal toxicity, oligospermia and amenorrhea.

The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received mesalazine.

Eligibility Criteria:
Inclusion Criteria:

* Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria.
* Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
* Subjects should have a CDAI score between 150 to 270 at week 0.
* Able to swallow tablets.
* Are capable of providing written informed consent and obtained at the time of enrollment.
* Willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

* Bacterial, viral or other microbial infection(including HIV).
* Orally administered corticosteroids within 3 weeks before enrollment, Inhaled or dermatologic preparations for the treatment of other diseases are acceptable.
* Used of infliximab or immunosuppressant within 2 months before enrollment.
* Previous use of prescription doses of NSAIDs without efficacy.
* Treatment with narcotic pain medications(Anti-diarrheal agents such as loperamide and diphenoxylate are permitted).
* History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis).
* History of abnormal liver function tests, including AST or ALT \>1.5 times upper limit of normal, alkaline phosphatase \>2 times upper limit of normal, total bilirubin \>2.5 mg/dL at screening (or within the previous 6 months, if known).
* History of malignancy.
* Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
* Participation in other clinical trial within the past 3 months.