cyrilzakka/clinical-trials huggingface dataset:
Microbiome and Endometrial Receptivity in Obese Infertile Women

The objective of this project is the identification and quantification of the main bacterial communities present in the endometrial microbiota in obese infertile patients, to assess if there is an alteration of their composition dependent on the body mass index, and if such alteration it could influence the reduction of endometrial receptivity, demonstrated in obese women. If obese patients have an altered digestive microbiota and, at the same time, a lower endometrial receptivity, the investigator want to assess whether such reduction in receptivity may depend on an alteration in the endometrial microbiota, which in non-obese infertile patients has been shown to negatively influence the reproductive results

The main objective of our study is to compare the composition of the endometrial microbiota between patients with normal weight and patients with obesity.

A. Secondary Objectives/research questions

* To analyze the composition of the digestive microbiota through samples of saliva and feces in infertile patients with normal weight and obesity.
* To assess whether there is a relationship between the body mass index (normal weight, obesity Class I, Class II, Class III) and the main bacterial species detected in endometrial fluid samples from infertile patients.
* To evaluate the influence of the digestive microbiota on the composition of the endometrial microbiota according to the body mass index in infertile patients.
* To evaluate if there is an influence of the endometrial microbiota on the results of endometrial receptivity analyzed with the non-invasive Endometrial Receptivity Array test (niERA)

Eligibility Criteria:
Inclusion Criteria:

* Infertile patients undergoing artificial cycle with HRT.
* Normal uterus confirmed by ultrasound (absence of uterine pathology such as submucosal or intramural myomas\> 4 cm that deform cavity, endometrial polyps or Müllerian anomalies, or adnexal as communicating hydrosalpinx).
* Negative serological tests for HIV, HBV, HCV, RPR

Exclusion Criteria:

* Taking prescribed antibiotics or using IUDs or contraceptives 3 months prior to taking the sample. NOTE: Patients who have taken prophylactic antibiotics for ovarian puncture may be included at least 1 month before taking the sample.
* Age\> 45 years
* Uncorrected uterine pathology, uncorrected hydrosalpinx
* Recurrent miscarriage (≥2 spontaneous abortions) or failure of implantation (transfer of 6 embryos in day 3 or 4 blastocysts in a cycle of IVF or donation of oocytes without gestation)
* Existence of serious or uncontrolled bacterial, fungal or viral infections that, in the opinion of the principal investigator, could interfere with the participation of the patient in the study or in the evaluation of the results of the study.
* Any disease or medical condition that is unstable or could endanger the patient's safety and compliance in the study.
A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.

The study is designed to assess if esreboxetine can improve the cognitive function of patients with fibromyalgia. Cognitive function is defined as the ability to concentrate, remember things and make decisions or problem solve. The study is also designed to assess if there is a difference in cognitive function between fibromyalgia patients and matched control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a recognised diagnosis of fibromyalgia, with defined minimum pain criteria. Control subjects must not have a fibromyalgia diagnosis or symptoms and must match fibromyalgia subjects for age, length of education and gender

Exclusion Criteria:

* Other confounding pain, cognitive disease or impairment, disease that could put the subject at risk or subjects who are on prohibited medications that cannot be washed out.
* Any subjects with a diagnosis of certain psychiatric disorders in particular major depression or suicidal risk. Matched control subjects have similar exclusions.
COVID-19 Detection Test in Oncology

EVIDENCE is a non interventional, French, multicenter study. Patients will be screened by local severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassay in their oncology department (rapid diagnostic test (RDT) or enzyme-linked immunosorbent assay (ELISA)). In patients with positive local SARS-CoV-2 immunoassay, a centralized SARS-CoV-2 ELISA will be performed in order to double check the immune response of all patients considered immune by local immunoassay.

Patients with cancer are a high-risk group in the COVID-19 pandemic. They are already vulnerable to infection because of their underlying illness and often immunosuppressed status, and are at increased risk of developing severe complications from the virus, including intensive care unit admission or even death. In light of this increased risk, many guidelines have been issued, aiming at minimizing the risk of SARS-CoV-2 infection occurrence and/or gravity. These changes in cancer care could however translate in less efficient or delayed treatments. In this study, we want to detect cancer patients that were exposed to the SARS-CoV-2 virus and acquired an immunity. These patients immune to the SARS-CoV-2 virus are susceptible to receive the standard of care, meaning the most appropriate treatment to manage their cancer. Large-scale serodiagnosis are considered as the solution to progressively relax the current lockdown in France. RDT and ELISA, which were not available until mid-April 2020, will be largely used in the general French population over the coming months, millions of tests have already been ordered by French authorities and companies.

The aim of this study is to control that oncology patients qualified immune by local immunoassay are indeed safe (i.e. have extremely low risk of SARS-CoV-2 infection following a positive local immunoassay test). Of note, several immunoassays (RDT or ELISA) will be used in the participating centers throughout the study. A confirmation of positive cases yielded by these different immunoassays will be performed by a centralized ELISA, in order to minimize the risk of false positive results.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years old
2. Patient diagnosed with invasive cancer (solid tumor only)
3. Patient in active phase of cancer treatment (surgery, chemotherapy, radiotherapy, immunotherapy or targeted therapy ongoing or planned within the next month- excepted patient treated by hormonotherapy and targeted therapy alone in adjuvant setting)
4. Patient with a local immunoassay realized before inclusion realized during the standard practice with a positive or negative result (test name and reference should be available)
5. Information and non-opposition of the patient to the study procedure

Exclusion Criteria:

1. Person deprived of their liberty or under protective custody or guardianship
2. Patients unwilling or unable to comply with the medical follow-up required by the study because of geographic, familial, social, or psychological reasons
3. Patients treated for a hematological malignancy
4. Life expectancy \<6 months
Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence

The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.

The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.

This is a multi-center, prospective, non randomized clinical trial comparing baseline data to the 12 month data. Urodynamic testing, pad weights and a direct visual stress test will be used to determine success along with the Stamey score.

Eligibility Criteria:
Inclusion Criteria:

* Women
* 18 years or older
* Diagnosed with stress urinary incontinence with or without urethral hypermobility
* Willing to sign informed consent
* Candidates for surgical intervention for stress incontinence
* Negative urinalysis or urine culture within 2 weeks of implantation
* Normal cystourethroscopy
* Failed at least 6 months of previous treatments for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc.)
* May have failed suspension or sling procedures

Exclusion Criteria:

* Pregnant or lactating
* Life expectancy of less than one year
* Insulin dependant diabetic
* Auto-immune disease
* Undergoing radiation therapy
* Active urinary tract infection
* Detrusor instability refractory to meds
* Reduced bladder compliance
* Significant bladder residual \>100mls
* Bladder cancer
* Unsuccessfully treated bladder stones
* Current urethral stricture preventing the passage of a 24 French endoscope
* Neurogenic bladder
* Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher
* Prior pelvic radiotherapy
* Artificial urinary sphincter implanted
Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma

Primary objective:

To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in the first line treatment of metastatic or recurrent nasopharyngeal carcinoma.

Secondary objectives:

To assess the toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms in the first line treatment of patients with metastatic or recurrent NPC.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically proven nasopharyngeal carcinoma (NPC) with metastatic or recurrent disease that is not amenable to potentially curative surgery or radiotherapy. They must not have prior chemotherapy for the treatment of metastatic or recurrent disease.
* Prior neoadjuvant, adjuvant or concurrent chemotherapy is allowed as long as a minimum period of 6 weeks has elapsed since the last day of treatment. This includes the use of carboplatin or cisplatin.
* Patients must have at least one uni-dimensional measurable lesion (according to RECIST criteria)
* Prior RT or surgery to the target lesion(s) is allowed as long as there is documented disease progression within the RT/ surgical field, and a minimum period of 6 weeks has elapsed since the last day of treatment.
* Eastern Cooperative Oncology Group performance status of 0-2
* No serious, uncontrolled medical conditions that may be aggravated by treatment.
* No other malignancy(s), except completely excised basal or squamous cell carcinoma of the skin, or completely treated carcinoma-in-situ of the cervix.
* Adequate hematological function:absolute granulocyte count \> 1.5 x 10\^9/L, platelet count \> 100 x 10\^9/L
* Adequate renal and hepatic functions:·serum creatinine \< 1.25 x upper normal limit (UNL) or a calculated creatinine clearance \> 50 mL/min·serum bilirubin \< 2 x UNL and Aspartate aminotransferase/Alanine aminotransferase \< 3 x UNL

Exclusion Criteria:

* Prior treatment with Oxaliplatin or Gemcitabine.
* Patients who have persistent grade 2 or more sensory and/or motor neuropathy, or ototoxicity resulting from prior cisplatin/ carboplatin.
* Active or past history of central nervous system metastasis from the primary tumor
* Potentially life-threatening infections
* Patients have used any investigational drug treatment in the month prior to inclusion.
* Pregnancy or not exercising appropriate birth control during the course of the study. Breast-feeding women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Clinical Study of Asahi ViE Dialyzer in Canada

The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21) .

The objective of the study is to evaluate specific parameters related to ViE-21 performance including (A) Performance evaluated by uremic solute removal rates of urea, creatinine, albumin and B2-MG, (B) Determination of KUF, (C) Biocompatibility evaluated by WBC, platelet and C3a measurements, (D) Type and number of adverse events, (E) Type and number of device malfunctions.

Prospective, open-label, non-randomized, single-armed, controlled study. Each patient shall have data collected for six dialysis sessions each on a control dialyzer prior to and after 36 sessions with the ViE-21. These data shall be the basis of comparison for the ViE-21 performance.

These data will be utilized in support of a US Regulatory Submission.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years and ≤ 80 years of age
2. Stable on maintenance hemodialysis for at least 12 weeks
3. Patients expected to remain on hemodialysis for at least 24 weeks
4. Patients on hemodialysis for more than 3 hours per treatment and on a 3 times per week schedule
5. Patients whose vascular access is obtained via arteriovenous fistula or graft, is well maintained and is capable of obtaining blood flow rate ≥ 350 mL/min during the study period
6. Patients using high-flux dialyzers (KUF ≥ 40 mL/hr/mmHg) with surface area ≥ 1.5 square meters and ≤ 2.2 square meters
7. Patients capable of understanding the informed consent form
8. Written consent and willingness to participate in the study

Exclusion Criteria:

1. Medical conditions requiring regular blood transfusion
2. Patients with a history of more than one week hospitalization related to infection, inflammation or surgery within the past 12 weeks
3. Patients having participated in another clinical investigation within the past 12 weeks, currently participating or having a plan of participating in any other clinical investigation (patients in an observational study without any interventions or in post-market surveillance do not need to be excluded)
4. Patients who have difficulty in maintaining vascular access function within the past 12 weeks
5. Patients who are known to be hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positive
6. Female patients who are pregnant, breast feeding or planning a pregnancy within the study period
7. Patients having received blood purification therapy other than conventional dialysis within the past 12 weeks
8. Patients who cannot tolerate Heparin
9. Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify a patient from participation
Multiple Sclerosis: The Role of Mitochondrial Dysfunction in IR Resistance

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS) and is one of the most common neurological diseases, often leading to disability of the patients. The MS pathogenesis includes vascular and inflammatory components, however recently also the role of mitochondrial dysfunction being a hot topic in neurodegeneration.

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS) and is one of the most common neurological diseases, often leading to disability of the patients. The MS pathogenesis includes vascular and inflammatory components, however recently also the role of mitochondrial dysfunction being a hot topic in neurodegeneration. Current project is based on previous project results, where the investigators of this project found signs of insulin resistance (IR) with hyperinsulinemia in patients with MS, which seem not to be related to chronic inflammation or low physical activity. Therefore aim of the present project is to elucidate impact of mitochondrial dysfunction in the pathogenesis of impaired insulin action and its role in the neurodegenerative process. To test the hypothesis, mitochondrial function, endothelial function, changes in membrane proteins and function of autonomic nervous system will be assessed. Those parameters will be measured non-invasively and in samples of blood, cerebrospinal fluid and skeletal muscle. MS patients will be examined at the time of diagnosis and after 12 months of treatment; healthy subjects will be used as controls. Elucidation of insulin resistance cause and the role of mitochondrial dysfunction in pathogenesis of disease is expected. Potential outcome of the project could be the answer, if pharmacological or non-pharmacological intervention might lead to improvement of mitochondrial function and therefore represent a new approach to prevent MS progression.

Eligibility Criteria:
Inclusion Criteria for MS patients:

* Age: 18-45 years
* Recent diagnosis of MS based on McDonald criteria
* Functional disability defined by the EDDS in the range of 2 to 6
* Patient demonstrates ability to successfully perform physical therapy exercises and procedures independently or with assistance of a caregiver

Exclusion Criteria:

* smoking, pregnancy, lactation, received a course of steroids (intravenous or oral) within 60 days of screening, diabetes, hypertension
Corneal Biomechanical Properties in Pregnancy

57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first week of the menstrual cycle were enrolled in the study. All subjects had a detailed ophthalmologic examination including the best corrected visual acuity with a Snellen chart, slit- lamp biomicroscopic evaluation, and indirect fundoscopy. The biomechanical properties Corneal Hysteresis, Corneal resistance factor, corneal compensated intraocular pressure and Goldmann-correlated intraocular pressure values were measured with ORA (Ocular Response Analyzer, software version 1.02, Reichert, Inc.) Central corneal thickness was measured with a built-in ultrasonic pachymeter attached to the ORA device.Axial length , Anterior chamber depth , and keratometry readings were acquired with an ocular biometer (IOLMaster; Carl-Zeiss Meditec, Inc.) before CCT determinations had been taken. Results of these parameters were compared between pregnant group and healthy control group.


Eligibility Criteria:
Inclusion Criteria:

* 57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first week of the menstrual cycle were included in the study.

Exclusion Criteria:

* Exclusion criteria included history of intraocular surgery or refractive surgery, history of glaucoma or glaucoma suspicion, contact lens wear, systemic autoimmune disease or diabetes and usage of eye drop and oral contraceptives.
Pattern of Use of Bevacizumab or Cetuximab + FOLFIRI Regimen as First-line Treatment in Metastatic Colorectal Cancer

* Registry
* Multicenter, prospective observational study
* Observe adverse events and efficacy in recruited patients for 3 years under real world settings.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients at least 19 years of age with metastatic colorectal cancer who are planned to receive Bevacizumab or Cetuximab in combination with FOLFIRI regimen as first-line treatment
2. Patients who will receive irinotecan, a component of FOLFIRI regimen, using Camtop Injection®

Exclusion Criteria:

1) Patients with conditions in which any study drug is contraindicated per the respective approved label.
Rifaximin Modify the Pathogenesis of Non-Alcoholic Fatty Liver Disease (NAFLD)

In this multicentric, double-blind, randomized,placebo-controlled study, the investigators hypothesized that rifaximin might act on Gram-negative bacteria and intestinal bacterial overgrowth(IBO) thereby inhibiting lipopolysaccharides(LPS)-mediated proinflammatory cytokine production. This work evaluates the efficacy of 6 months administration of rifaximin in NAFLD patients.

The investigators aimed to study the effect of rifaximin on NASH. 50 patients with biopsy-proven NASH were enrolled in this double-blind, randomized,placebo-controlled study. BMI, AST, ALT, gamma glutamyl transferase (γ-GGT), lipid profile, homeostatic model assessment (HOMA), serum endotoxin, Toll-like receptor 4 (TlR4), interleukin-6 (IL-6), IL-10, tumor necrosis factor-α (TNF-α) and cytokeratin-18 (CK-18) levels were measured before and after a 6 month administration of rifaximin (1100mg/day, 550 mg tablets 1 × 2 before meals).

Eligibility Criteria:
Inclusion Criteria:

1. women or men aged 18-65 years.
2. biopsy-proven NASH without or with mild to moderate fibrosis (fibrosis stage 0-3)in the preceding year.
3. persistently abnormal ALT on 2 occasions.
4. participants have provided written informed consent before screening.
5. all patients counseled about the standard of care treatment (e.g., diet andexercise).
6. Strict requirements for weight stability between the time of biopsy and study entry.

Exclusion Criteria:

1. Cirrhotic NAFLD (METAVIR stage 4).
2. Combined viral hepatitis B and C infection.
3. increased alcohol intake (\>20 g/day) and hypothyroidism.
4. co-existence of another type of biliary tract or pancreatic or liver diseases
5. lactating or pregnant women.
6. allergy to rifamycin or rifaximin.
7. systemic inflammatory conditions (e.g. Connective tissue diseases and inflammatory bowel diseases).
8. bariatric surgery and blind loop.
9. evidence of hepatic decompensation (ascites, hepatic encephalopathy, and varices),
10. history of myocardial infarction and/ or stroke within 6 months.
11. drugs that alter the gut flora e.g. Lactulose, systemic antibiotic, cholestyramine within three months, (l) cancers especially HCC, and (m)patients with renal impairment (estimated GFR \<60ml/min/1.73m2).

(n) Major dose change orintiation of biguanides, metformin, thiazolidinediones, insulin, fibrates, statins, and anti-obesity medications within three months before the onset of the study.
Registry of Coronavirus Complications - CORRELATION WITH GLYCOMIC PROFILE in COVID-19 Patients

COVID infection has resulted in multi-organ injury and may result in cardiovascular, pulmonary, neurological, and muscular damage. It is associated with significant asthenia and the long-term effects of the infection are still unclear, particularly for the development of pain and delayed functional rehabilitation.

Glycomics "is the systematic study of the structure of glycans in a given cell type or organism. Glycans are complex oligosaccharides attached to proteins and lipids that regulate a variety of organic processes, including immunity Thus, glycans may influence different moments of the response to the virus and involved in the clinical severity of the disease, but may also change depending on the severity of symptoms and the organic response to SARS-CoV-2 infection.

Glycomic data could provide important insights into interindividual differences at the molecular level that directly interact with SARS-CoV-2 and the development of mid- and long-term side effects. The ability to identify early those susceptible to developing COVID-19 infection and at higher risk for COVID-19 with unfavorable outcomes long after infection would help guide therapeutic strategy and provide important guidance for rational health care organization, which is of outmost importance.

Long-term outcome data regarding post-COVID patient functional capacity and glycomics will be compared to assess whether there may be differences in protein glycosylation that may predict patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of COVID19 virus infection (buffer/BAL/positive IgG serology)
* Age \>18 years
* Able to express informed consent to participate in the study

Exclusion Criteria:

* patients unable to express consent,
* patients aged \<18 yr,
* with signs and symptoms compatible with Covid-19 but without certified diagnosis by swab/BAL or serological examination of presence of COVID IgG antibodies