cyrilzakka/clinical-trials huggingface dataset:
Liquid Biopsy for NASH and Liver Fibrosis

Nonalcoholic fatty liver disease (NAFLD) has evolved to represent the most common cause of chronic liver disease globally. Today, NAFLD is a leading indication for liver transplantation and a major etiology for hepatocellular carcinoma (HCC) in the United States. NAFLD is characterized by the excess accumulation of lipids within the liver and ranges from isolated steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by the presence of hepatic necroinflammation, hepatocyte ballooning and fibrosis progression.

Currently, liver biopsy remains the gold standard for the diagnosis of various chronic liver diseases, and for determining the severity of liver injury, inflammation, and fibrosis stage. However, this procedure is invasive, prone to complications such as bleeding and is associated with sampling variability and limited representation of the whole liver. Other limitations include, the difficulty to monitor liver injury progression over time and underestimation of disease severity.

Despite intensive research, currently available non-invasive blood tests are not sufficiently sensitive or specific and are therefore of limited use. Blood biomarkers might provide significant advances in the diagnosis and monitoring of disease progression and regression in clinical settings.

Recently, liquid biopsy has emerged as a potential, less invasive, alternative to liver biopsy. In fact, it addresses several unmet clinical needs, including sensitivity, specificity, the determination of prognoses, and the prediction of therapeutic responses.

This is a multicentric prospective observational study to validate blood non-invasive biomarkers for NASH and fibrosis stage.

150 subjects will be enrolled; 100 subjects with biopsy-proven NASH and 50 subjects with normal liver will be used as controls.

Eligibility Criteria:
Inclusion Criteria:

One hundred subjects with NASH documented by liver biopsy and no evidence of another form of liver disease with a BMI ≥30 and ≤55 kg/m2.

Fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls.

Exclusion Criteria:

Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 6 months; Liver cirrhosis; End stage renal failure; Participation in any other concurrent therapeutic clinical trial; Any other life-threatening, non-cardiac disease; Pregnancy; Inability to give informed consent; Substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men); Wilson's disease; Lipodystrophy; Parenteral nutrition; Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids).
Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis

Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare immune system disorder that causes asthma, an excessive number of eosinophils (a type of white blood cell) in the blood, and the inflammation of blood vessels, or vasculitis. In order to properly treat EGPA, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of this disease in people with EGPA.

EGPA, also known as allergic granulomatosis angiitis, is a systemic vasculitis. EGPA is marked by three distinct symptoms: asthma; eosinophilia, evidenced by an excessive number of eosinophils in the blood and tissues; and vasculitis involving the skin, lungs, nerves, kidneys, and other organs. Nerve involvement may also occur in EGPA, causing pain, tingling, numbness, and muscle wasting in the hands and feet. Because EGPA patients may not show any visible signs of active disease, current methods of monitoring disease progression usually represent a period of extended inflammation and disease activity. Thus, patients may go untreated during a period of undetectable disease when damage might be preventable. This study will use novel scientific methods to identify new biomarkers that can be used to monitor disease activity in EGPA patients. These biomarkers may be used to help direct clinical care for EGPA patients and assist in future drug development.

Study visits will occur every 6 months, or annually. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.

Eligibility Criteria:
Inclusion Criteria:

Patients with a diagnosis of eosinophilic granulomatosis with polyangiitis are eligible for the study.

Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

- Inability to give informed consent and to sign the consent form
Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot

The purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot.

CVP(central venous pressure) and cardiac output are serious index in children with Tetralogy Of Fallot after the corrective repair.The purpose of this study is to investigate if the therapy of rhRNP can improve the survival and life quality after the corrective repair of Tetralogy Of Fallot.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained from patient's legally acceptable representative.
* Pediatric patients after Repair of Tetralogy Of Fallot.

Exclusion Criteria:

* Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
* Treatment or planned treatment with another investigational drug within 3 months of screening.
* Known hypersensitivity to bosentan or any of the excipients
* cardiogenic shock and inclination of hypotension（SBP\< 60mmHg）.
Naproxen Sodium Extended-Release Actual Use Study

The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.

Issues on adverse event data are addressed in the Adverse Event section.

The following acronyms and abbreviations were used in the results section.

- General Educational Development (GED)

Eligibility Criteria:
Inclusion Criteria:

* Self report use of Over The Counter (OTC) analgesics
* Able to read and understand English
* Provide written informed consent (subjects 12- 17 years of age provide written as sent and/ or parent or legal guardian provide written consent)
* Purchase the investigational product

Exclusion Criteria:

* Have participated in a study involving OTC analgesics in the last 12 months
* They or someone else in the household work for a market research company, an advertising agency, a public relations firm, pharmaceutical company, as a healthcare professional, or as part of a health care practice
* Have a history of known allergies to nonsteroidal anti-inflammatory drugs (NSAIDs) (i.e., Naproxen, Ibuprofen, etc) or Aspirin
* Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days
* (Female subjects) are pregnant or breastfeeding
Baduanjin Versus Brisk Walking for Cognition in Schizophrenia

The current study intends to recruit participants with schizophrenia for the practice of Baduanjin, brisk walking, and health education after enrollment. The study also including a maintenance program. Cognitive and physical function assessments will be conducted before, after, and during follow-up tests. The research hypothesis posits that both Baduanjin and brisk walking will confer beneficial effects on various aspects of cognitive and physical functions.

Cognitive function deficits are core features in patients with schizophrenia. These deficits need active intervention to prevent functional decline. Baduanjin and brisk walking show promise as interventions in patients with schizophrenia. This study investigated the effects of Baduanjin exercise versus brisk walking in patients with schizophrenia.

This study will be a single-blind, 3-arm, parallel, randomized controlled trial.

A total of 120 patients with schizophrenia will be enrolled and randomly assigned to the Baduanjin group, brisk walking group or control group. The intervention group will practice Badunjin exercise. While participants in brisk walking group will receive brisk walking at the same duration. The controls will watch videos that are not aimed at improving physical exertion. Maintenance programs will also be conducted for participants to encourage practicing in exercise after intervention. All group will undergo evaluation at three time points: baseline, immediately after intervention and 4-week follow up after intervention. The primary outcome will be cognitive function and physical function. Secondary outcomes will include mood, sleep quality, and quality of live.

Eligibility Criteria:
Inclusion Criteria:

1. Having a diagnosis of schizophrenia according to the DSM-5.
2. Who will be above 20-65 years of age .
3. Having a stable mental status without shift in medication and keep in same dose for at least one month.
4. Being able to walk independently for 50 meters.

Exclusion Criteria:

1. Serious physical conditions that will impede participation, such as cardiovascular disease, musculoskeletal disease or pulmonary system disease.
2. Visual or auditory impairment that precludes completion of assessment.
3. Acute psychosis requiring hospitalization.
4. Presence of severe withdrawal or profound cognitive disability that cause difficulties in following instructions.
Treatment of Severe Infections With Mesenchymal Stem Cells

The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.

Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10\^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line or 250 ml albumin 4% alone.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock of community origin since less than 12 hours. The onset time of septic shock is the time of catecholamine introduction( adrenaline, noradrenaline, or dopamine \> 8μg/kg/min)
* At least 2 organ failure other than hemodynamic
* Occurrence between Monday 8am and Friday 8am (for availability reasons of staff)
* Signature of informed consent (patient/close relative or reliable person)
* Affiliation to social security plan

Exclusion Criteria:

* Non-septic shock
* Nosocomial septic shock
* PaO2/FiO2 \<100
* Pregnant or breast-feeding woman
* Brain death
* Dying person
* Therapeutic limitations
* Participation to another current interventional clinical trial or since less than 30 days
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia

To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain experienced in post-herpetic neuralgia (PHN) as measured by changes in PI-NRS after three weeks of treatment compared to the baseline period.

A 3 week randomised crossover study to investigate the effect of repeat oral dosing of CNV2197944 75 mg tid versus placebo for on the pain experienced in post-herpetic neuralgia (PHN. Each 3 week treatment period is seperated by a 2 week washout period. The primary outcome measure is the change from baseline in the PI-NRS after three weeks of treatment. Secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the Neuropathic Pain Symptom Inventory.

Eligibility Criteria:
Inclusion Criteria:

Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent.

Patients with post-herpetic neuralgia (PHN) with pain at screening present for more than 3 months after healing of the herpes zoster skin rash. The maximum duration of PHN will be no longer than 5 years.

Exclusion Criteria:

Patients having other severe pain, which may impair the self-assessment of the pain due to PHN.

Patients who have received nerve blocks for neuropathic pain within 4 weeks prior to the start of the single-blind placebo run-in Certain medications used to relieve the pain of PHN, specifically gabapentinoids (gabapentin and pregabalin), carbamazepine and topical agents (eg capsaicin, lidocaine) Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin.

Patients taking more than one medication to treat the PHN pain
The Effect of Creatine on Muscle Loss

The primary aim of this study is to determine the effect of creatine supplementation on muscle mass loss during short-term immobilisation in healthy, young people.

Seven days of one-legged knee immobilisation in young subjects with creatine or Placebo supplementation. A randomly selected leg is immobilized for seven days. Muscle mass and strength will be determined and muscle biopsies will be collected before and immediately after immobilisation. A week after the cast is removed we will assess any differences in recovery between intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged from 18-35 years
* 18.5 \< BMI \< 30 kg/m2

Exclusion Criteria:

* (Family) history of thrombosis
* Smoking
* Recent surgery
* Performing regular resistance training more than once per week in the past year
* Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
* Current systemic use of corticosteroids, growth hormone, testosterone, immunosuppressants or insulin
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis)
* Use of anti-coagulants
* Pre-existing renal disease or those with a potential risk for renal dysfunction (diabetes, hypertension, reduced glomerular filtration rate)
Treatment of Reflux With Sleeve Gastrectomy

In 2008, the World Health Organization (WHO) report found that 0.5-1.5 billion people aged 20 years and above suffer from overweight (body mass index (BMI) ≥ 25) and obesity (BMI ≥ 30 kg / m2) stated.

WHO estimates that the number of overweight and obese people will reach 2.3 and 0.7 billion, respectively, by 2045.

Bariatric surgery has been developed in response to the number of obese patients living in the world and the complications caused by obesity. The most common type of bariatric surgery against obesity is Laparoscopic Sleeve Gastrectomy (LSG).

As after any surgical operation, complications may occur after Laparoscopic Sleeve Gastrectomy. Additional operations may be required to correct complications such as bleeding, anastomotic leak, gastric volvulus, infection, dyspepsia, hiatal hernia, bile and/or acid reflux.

The incidence of gastroesophageal reflux disease (GERD) is significantly increased in obese patients compared to the incidence in normal individuals. Various studies have shown that obesity causes delayed gastric emptying due to increased abdominal pressure, esophageal motility disorders, especially hypotensive lower esophageal sphincter pressure (\<10 mm Hg), finally the development of hiatal hernia (HH), whose prevalence in the obese population is significantly higher than in non-obese patients.

Various surgical methods have been presented to prevent postoperative de-novo Gastroesophageal Reflux and de-novo Hiatal Hernia that occur after LSG. Curorrhaphy is one of these techniques that is accepted to prevent the formation or exacerbation of postoperative GERD and Hiatal Hernia.

In this surgical technique, after the diaphragmatic crura are completely exposed at the level of the lower esophageal sphincter (LES), the hiatal hernia, if present, is reduced into the abdomen. Afterwards, Z surgical sutures are applied to the diaphragmatic crura to make the diaphragmatic esophageal ring narrow enough. In this way, it is aimed to strengthen the diaphragmatic crus. Findings following cruroplasty for GERD prevention are varied. Although some authors state that the technique does not provide an advantage in preventing postoperative GERD, some studies have shown cruroplasty to be effective.

In this study, investigators aimed to show that the technique of simultaneous cruroplasty and single suture omentopexy with LSG is a treatment for GERD and HH, which are very common in obese patients, and a preventive technique for de-novo GERD seen after LSG.


Eligibility Criteria:
Inclusion Criteria:

* Obesity,

Exclusion Criteria:

* Eating disorder or mental disorder
* Misunderstanding of the protocol
* Psychiatric contraindication
* Patient participating in another interventional clinical research protocol involving a drug or medical device
* Pregnant, breastfeeding
Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve?

The purpose of this study is to investigate the effects of a multispecies probiotic on the function of the vagal nerve in patients with major depression and healthy participants in a single-center, randomized, placebo-controlled trial.

After being informed about the study and potential risks, all participants giving written informed consent will be screened for eligibility for study entry and will be randomized in a double-blind manner to receive either a multistrain probiotic or a placebo for 3 months. At entry, 1 week after inclusion, 4 weeks after inclusion and 3 months (end of study) vagal activity will be measured using a 24hr electrocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* informed consenct
* confirmed diagnosis of depression according to ICD-10 or DSM-V
* age between 18 and 65 years

Exclusion Criteria:

* Suicidality
* no informed consent or no ability to provide consent
* cardiovascular disease
* pregnancy, breastfeeding
* alcohol or drug dependency
* other severe psychiatric or organic conditions (epilepsy, brain tumor, recent surgery)
* malignant diseases
* dementia (MMST\<20)
* severe autoimmune-disorder or immunosuppression (systemic lupus, HIV, multiple sclerosis)
* antibiotic therapy in the last month
* misuse of laxative
* acute infections
* diarrhoea
* gastrointestinal surgeries (except appendectomy)
* no probiotic intake in the last 6 months
* no regular intake of other supplements, probiotics or antibiotics during the study
Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

This is an open-label, parallel-group study to evaluate the safety and efficacy of ropanicant in participants with moderate to severe Major Depressive Disorder (MDD).

Approximately 36 participants will be randomly assigned to receive ropanicant either 45 mg qd, 30 mg bid, or 45 mg bid for 2 weeks, in a ratio of 1:1:1 (12 participants in each treatment group). Following a screening period of up to 4 weeks, the participants will be treated for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participants must meet the DSM-5 criteria for MDD without psychotic features and diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI).
* Participants with a current major depressive episode of at least 4 weeks of duration prior to the screening visit.
* Participants must have an MADRS score of ≥25 at the screening and the baseline visits.
* Participants must have a score of ≥4 on Clinical Global Impression - Severity (CGI-S) Scale at the screening and the baseline visits.

Exclusion Criteria:

* Participants who meet criteria for treatment-resistant depression during the current major depressive episode, which will be defined as being non-responders (less than 50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration as defined by the Massachusetts General Hospital (MGH) Antidepressant Treatment Response Questionnaire (ATRQ).
* Participants taking antidepressant treatment (SSRIs and SNRIs) or any medication that is contraindicated with the use of monoamine oxidase inhibitors (eg, opioids, stimulants) within 2 weeks (or 5 half-lives, whichever is longer) prior to baseline and until the end of study visit.
* Participants who do not agree to avoid tyramine rich diet from the start of dosing and until 2 weeks following last study drug administration.
* Participants who are habitual smokers or using nicotine products.
Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.

Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. A recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to rivaroxaban. However, no results are available on the minimal dose of activated charcoal necessary in rivaroxaban poisoning. The objective of this study is to evaluate the effect of 4 dosing regimen activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments modalities will be studied: rivaroxaban with 50g, 24g, 12g and 6g of activated charcoal administrated 3 hours after rivaroxaban intake.


Eligibility Criteria:
Inclusion Criteria:

* Affiliated or beneficiary of a social security category
* Having signed the inform consent form
* Having signed the biologic consent form
* Men aged between 18 and 40 years
* Weight between 55 and 92 kilogram
* normal clinical exam
* normal biological exam

Exclusion Criteria:

* Contra-indication to rivaroxaban
* Contra-indication to activated charcoal
* With a history of hemorrhagic disease
* Smoker
* Organic lesion likely to bleed
* Severe liver disease
* Severe kidney failure
* Gastroduodenal ulcers
* Any medication taken during the week prior to the start of the study
* Consumption of grapefruit juice
* Routine ingestion of excessive amounts of coffee, tea, chocolate and/or caffeinated beverages
* Practice of violent sports
* Fructose intolerance
* Glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency syndrome
* Notable medical history (cardiovascular pathology, pulmonary, neurology ...)