cyrilzakka/clinical-trials huggingface dataset:
High Energy Phosphate Metabolites in Brain

The objective of this research project is to determine the impact on brain HEP metabolites and fluxes of an oral consumption of a commercially available nutrition product (Peptamen® 1.5 vanilla) in healthy volunteers.

Therefore, we intend to perform 31P-MRS before and after oral intake of the nutrition product.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18-45 years
* Healthy, based on the medical screening visit
* Normal BMI for age (18.5-25.0 kg/m2)
* Able to understand and to sign a written informed consent prior to trial entry
* Informed consent signed

Exclusion Criteria:

* Known type 1 or type 2 diabetes, on anamnesis
* Family history of type 2 diabetes (parents)
* Any other metabolic disease possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert)
* Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc
* Any history of neurological / psychological disease (meningitis, epilepsy), to the opinion of the investigator
* Claustrophobia
* Hearing disorders
* Any medication impacting dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates , to the opinion of the medical expert
* Pregnancy (on anamnesis) and/or lactation
* Having any metallic, electronic, magnetic, or mechanical implants, devices, or objects, for safety reason linked to magnetic field exposure (MRS):

  * Aneurysm clip(s)
  * Cardiac pacemaker
  * Implanted cardioverter defibrillator (ICD)
  * Electronic implant or device
  * Magnetically-activated implant or device
  * Neurostimulation system
  * Spinal cord stimulator
  * Cochlear implant or implanted hearing aid
  * Insulin or infusion pump
  * Implanted drug infusion device
  * Any type of prosthesis or implant
  * Artificial or prosthetic limb
  * Any metallic fragment or foreign body
  * Hearing aid
  * Other implant
* Subject injured by a metallic object or foreign body
* History of cancer within the past year
* Allergy or intolerance to any food or compound used
* Currently following a strict exercise program (minimum three times per week) in order to either lose weight, gain muscle or reach competition standards for a chosen sport
* Currently participating or having participated in a clinical trial during the past month
* Subjects not willing and/or not able to comply with scheduled visits and the requirements of the research protocol. Subject having a hierarchical link with the investigator or co-investigators.
* Subject who cannot be expected to comply with the research protocol.
Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery

The purpose of this study to compare erector spinae block to transversus abdominis plane block in bariatric surgeries regarding analgesic efficacy and postoperative oxygenation and respiratory complications

The erector spinae plane (ESP) block is an interfascial block proposed to provide analgesia for chronic pain and perioperative period. it can provide both visceral and somatic abdominal analgesia if the injection were performed at a lower thoracic level. ESP block is effective, easy to perform, and can be performed in a short time. Therefore, bilateral ESP block may have comparable or improved analgesic effect in upper and lower abdominal surgical procedures when compared to other suitable plane blocks.

Transversus abdominis plane (TAP) block technique is to reduce postoperative pain and is a part of current analgesic regimen for many abdominal surgeries . Moreover, it was found that posterior TAP block appears to produce more prolonged analgesia than the lateral TAP block. Ultrasound guided TAP block is a feasible, minimally invasive technique . It reduces the postoperative requirement of opioid analgesics, decreases the incidence and severity of postoperative nausea and vomiting, improves patient satisfaction, and allows early readiness for discharge postoperatively.

Both blocks is effective in reducing postoperative complication and need of analgesia , To our knowledge there is no comparative study between the two blocks to this population .

the investigators aim to compare the perioperative analgesic effect between TAP block and ES block in bariatric .

Eligibility Criteria:
Inclusion Criteria:

* Patient age \>18 \<60
* Obese patients ; Body mass index(BMI) 40-50 kg/m2
* Both sexes
* American Society of Anesthesiologists(ASA) physical status classes II and III
* Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB)surgeries

Exclusion Criteria:

* Refusal of regional block
* Patients with neurological, psychological disorders or those lacking cooperation
* Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea
* Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
* Patients with bleeding disorders defined as (INR \>2) and/ or (platelet count \<100,000/µL)
* Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
* Patients who are allergic to amide local anesthetics.
* Cases converted to open surgery will also be excluded from the study
Golgi Protein for HCC Diagnosis

This case-control study was conducted on 90 patients who were equally divided into two groups. Group 1 included 45 patients with HCV-related chronic liver disease without clinical or radiological evidence of HCC (control group), and Group 2 included 45 patients diagnosed to have HCC by Triphasic abdominal CT (patient group). Serum AFP and GP73 were measured using ELISA technique


Eligibility Criteria:
Inclusion Criteria:

* patients were older than 18 years.

Exclusion Criteria:

* patients with hepatic focal lesions not due to HCC such as Hemangioma, Hepatic cyst, and liver metastases; patients infected with HIV; patients with any autoimmune disease; or patients with metastatic disease.
Comparison of Flexor Retinaculum Stretch and Carpal Mobilizations in Patients With Carpal Tunnel Syndrome.

Comparison of flexor retinaculum stretch and carpal mobilizations in carpal tunnel syndrome patients.

* Carpal Bones Mobilization tends to improve the symptoms of carpal tunnel syndrome.
* Manual stretching of the flexor retinaculum effective in CTS patients.
* As there are no studies available to compare the effectiveness of flexor retinaculum stretch and carpal bone mobilization for the treatment of CTS, hence the purpose of this study is to find the effectiveness of carpal bone mobilization and flexor retinaculum stretch in improving Pain, ROM and Functional Status in patient with CTS.

Eligibility Criteria:
Inclusion Criteria:

* Females
* Age between 18-40 years
* Unilateral CTS
* Already diagnosed patients of CTS.

Exclusion Criteria:

* Fracture of wrist
* Dislocation
* Congenital abnormalities
* Rheumatoid arthritis
* Osteoarthritis
* Liver failure
* Pregnancy
* Bilateral CTS
* Systemic neurological condition e.g.: GB syndrome, multiple sclerosis.
Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation

Aim/Background: This study aims to investigate the necessity and efficacy of a hepatitis B virus (HBV) vaccine booster in children after liver transplantation. A universal mass vaccination program of HBV was launched for 20 years in Taiwan. The coverage rate is high and the effect is great. The carrier rate of the population under vaccine coverage decreased from 10-15% to \< 1%. In Taiwan, most children who receive organ transplantation were vaccinated with HBV vaccine in infancy and well before the transplantation procedure. This vaccination background information on Taiwanese children is quite unique and not similar to the other countries in the world. The antibody generated by the vaccine usually wanes after a certain period even in normal subjects, let alone in subjects who receive organ transplantation and immunosuppressive agents after transplantation. At present, Taiwan is still an HBV hyperendemic area and the risk of exposure to HBV cannot be overlooked. Should children be given a booster dose of HBV vaccine after transplantation? And how about the immunogenicity of this booster dose in these immunocompromised hosts? If these children cannot obtain an adequate antibody titer, will the risk of HBV infection increase? This study is designed to answer these questions. As a pediatric hepatologist, the author's routine work is to take care of children who underwent liver transplantation. To take advantage of this, the investigators decided to study the efficacy and necessity of HBV booster vaccine in these patients. However, the results of this study should be able to be applied to any kind of solid organ transplanted patients.

Method: The anti-hepatitis B surface antigen (HBs) titer will be checked in patients who received liver transplantation \> 1 year ago. If the titer is \< 10 IU/L, a booster dose will be administered. The humoral (anti-HBs) and cellular immunity (by ELISPOT to assay T and B cell specific proliferation) and cytokine assay will be done in these patients before and after the booster dose. A three-year follow-up will be performed to monitor the HBV infection in these patients.

Expected Results: The investigators expect for those who survive one year more after liver transplantation to yield a relatively good response to HBV booster under adequate immunosuppression.

The anti-HBs titer will be checked in the patients who received liver transplantation for \> 1 year. If the titer is \< 10 IU/L, a booster dose will be administered. The humoral (anti-HBs) and cellular immunity (by ELISPOT to assay T and B cell specific proliferation) and cytokine assay will be done in these patients before and after the booster dose. A three-year follow-up will be performed to monitor the HBV infection in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Children who received liver transplantation \> 1 year ago

Exclusion Criteria:

* Are now in an unstable condition
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Tablets in Participants With Obesity

This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of ASC30 Tablets in participants with obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Have provided informed consent before initiation of any study-specific procedures.
2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
3. No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.

Exclusion Criteria:

1. Have evidence of any clinically significant active or chronic disease.
2. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
3. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
4. Have a history of acute or chronic pancreatitis.
5. Participants with a known clinically significant gastric emptying abnormality.
6. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
7. Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles on the Symptoms and Quality of Life of Patients With Chronic Venous Disease

The main objective is to evaluate the effect of wearing the insoles developed by Millet Innovation on the symptoms and quality of life of patients suffering from chronic venous disease.


Eligibility Criteria:
Inclusion Criteria:

* Chronic venous disease at CEAP C2S stage - the S means that patients must be symptomatic
* Women or men aged over 18
* Good general state of health
* High or average level of activity estimated by the GAPQ questionnaire
* Patient able to understand the requirements of the trial and having signed a free and informed consent prior to study entry
* Patient able to read and understand written instructions
* Patient able to complete the self-assessment questionnaires
* Patient with a foot size between 36 and 44

Exclusion Criteria:

* Low level of activity estimated by the GAPQ questionnaire
* Cardiac, inflammatory, liver, kidney and arterial disease
* Subject with non-venous oedema
* Subject with an open wound on the foot
* Subject unable to attend all 3 visits
* Patients unable to comply with the constraints of the protocol, in particular patients whose mental state does not allow them to understand the nature, objectives and possible consequences of the study.
* Pregnant or breastfeeding women or women who are expecting to become pregnant during the study.
* Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent
* Adults subject to a legal protection measure or unable to express their consent
* Any other reason which, in the opinion of the investigator, could interfere with the proper conduct of the study.
* Patient unable to wear shoes with a drop of less than 2.5cm for the duration of the study
* Subject already wearing orthopaedic insoles or standard insoles
Study of Dietary Intervention Under 100 MMOL in Heart Failure

This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be recruited from each research center if they are 18 years or older, with confirmed diagnosis of Heart Failure (including both those with a reduced and preserved systolic function), NYHA II-IV, and willing to sign informed consent.

Exclusion Criteria:

* Subjects will be excluded if they have severe hyponatremia (serum sodium \<130 mmol/L)
* Renal failure (a glomerular filtration rate \< 30 mL/min)
* Uncontrolled thyroid disorders
* Hepatic failure
* Implantable cardiac device (ICD or CRT) or myocardial revascularization procedures (coronary angioplasty and/or surgical revascularization) in the previous 3 months
* Uncontrolled atrial fibrillation or recurrent ventricular arrhythmias
* Malignancy, or with moderate-severe dementia.
* Patients will be excluded if, in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.
Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study

The aim of the study is to prospectively evaluate the safety and efficacy of micafungin when prescribed for prophylaxis or treatment of fungal infections in different real-world clinical conditions and centers, in pediatric patients in Asia/Oceania.

The study will collect safety and efficacy data from pediatric patients who are prescribed intravenous micafungin for prophylaxis. During this trial, patients with two separate indications will be treated. The first, Invasive candidiasis will have a minimum treatment of 2 weeks. The second, Oesophageal candidiasis will have a minimum treatment of 1 week. Both indications will have a follow-up period of 4 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Prescribed micafungin for prophylaxis or treatment of fungal infections.

According to treatment guidelines, micafungin may not be a suitable treatment for the following patients:

* The patient has evidence of impaired liver function: alanine aminotransferase (AST), aspartate aminotransferase (ALT) \>5 times the upper limit of normal (ULN) or total bilirubin \>2 times ULN.
* The patient has a history of allergy, hypersensitivity, or any serious reaction to the echinocandin class of antifungals.
* The patient has a confirmed systemic fungal infection with a non-Candida species.

Exclusion Criteria:

* The patient is receiving micafungin treatment in combination with other antifungal drugs.
Plant Stanols and Liver Inflammation in Overweight and Obese Children

Obesity is associated with a variety of co-morbidities. Children with obesity are more likely to have risk factors associated with cardiovascular diseases (CVD) and CVD risk markers (e.g. hypertension, elevated serum cholesterol, and type 2 diabetes mellitus), but also with organ specific pathologies such as a non-alcoholic fatty liver disease (NAFLD). A recent meta-analysis has shown that the prevalence of NAFLD in obese pediatric populations is approximately 35%, compared to approximately 8% in general pediatric population, making it a very important health threat in these populations. Successful pharmacological interventions to treat or prevent NASH are not yet available and so far only weight loss has clear benefits. However, it is well known that sustained weight-loss is difficult to achieve on the longer-term. The investigators recently demonstrated in mice that plant sterol and stanol ester consumption inhibited the development of liver inflammation. Moreover, Javanmardi et al. recently demonstrated in a population of adult NAFLD patients, that plasma concentrations of Alanine Transaminase (ALT) were reduced after daily plant sterol consumption (1.6 g/d) for 6 weeks. In this study, the investigators propose to evaluate the effect of consuming soft chews enriched with plant stanol esters (3 grams/day) on ALT concentrations in children with overweight or (morbid) obesity who are at risk of developing NAFLD, in a randomized, placebo-controlled, double blinded study with an intervention period and follow-up period of 6 months. 52 overweight and obese children with elevated ALT concentrations (\>39 U/L for boys and \>33 U/L for girls) will be included. All children will be randomly allocated to consume control or plant stanol ester enriched soft chews on a daily basis for a period of 6 months. After 12 months there will be an additional blood sample to evaluate whether the 6 months intervention is still effective.


Eligibility Criteria:
Inclusion Criteria:

* Participation in lifestyle intervention, provided by the Centre for Overweight Adolescent and Children Healthcare (COACH), at the Department of Pediatrics at the Maastricht University Medical Center (MUMC+).
* Age between 4-18 years old
* Plasma ALT concentrations above 39 U/L for boys and above 33 U/L for girls.
* Willingness to consume 6 soft chews on a daily basis, for a period of 6 months.

Exclusion Criteria:

* Presence of a severe medical condition, which contraindicates, in the investigators judgement, entry to the study.
* No signed informed consent by relevant parties (parents of children aged below 12 years, parents and or children aged between 12 and 16 years, or children aged 16 years and older).
Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

This clinical trial aims to test in female patients with systemic lupus erythematosus (SLE). The main question it seeks to answer is whether etonogestrel implants can protect ovarian reserve function in patients with SLE. Participants will be randomly divided into a test group and a control group. The test group will be implanted subcutaneously with etongestrel for one year. Researchers won't intervene in the control group. After three months of drug-eluting, researchers will compare measures of ovarian reserve function in the test and control groups to see if etonogestrel implants can protect ovarian reserve function in patients with SLE.


Eligibility Criteria:
Inclusion Criteria:

1. Systemic lupus erythematosus was confirmed
2. 18-37 years old

Exclusion Criteria:

1. History of sex chromosome abnormalities
2. History of abnormal thyroid function
3. History of abnormal adrenal function
4. History of pituitary disease
5. History of sexual hormone drug use in the past 3 months
6. History of ovarian tumors or invasive ovarian operations
7. Pregnancy
8. Have a birth plan in the next 1 year
9. Ovarian failure
Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma.


Eligibility Criteria:
Inclusion Criteria

* Evidence of myeloma according to the criteria of the British Columbia Cancer Agency (for the diagnosis, 2 of the 3 criteria must be met):

  * Evidence of paraprotein in the serum or urine
  * Bone marrow infiltration with plasma cells which represent more than 10% of the nucleated cells
  * Radiologically, at least one osteolytic lesion
* Asymptomatic patients with Stage I (Durie and Salmon) multiple myeloma

Exclusion criteria:

* Patients with more than one osteolytic lesion on conventional skeletal radiography
* Previous treatment with bisphosphonates
* bilirubin \> 2.5 mg/dl
* Abnormal renal function as evidenced by: A calculated creatinine clearance \< 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:

  * CrCl= \[140-age(years)\] x weight(kg)/\[72xserumcreatinine(mg/dL)\] X {0.85 for female patients}
* Patients with other malignant diseases or severe concomitant diseases
* Potentially fertile patients who are not using a reliable and appropriate method of contraception
* Pregnancy or breast-feeding
* Participation in another clinical study with an investigational drug within 12 weeks of study entry
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)

Other protocol-defined inclusion and exclusion criteria may apply.
Single-center Retrospective Study : Developmental Trajectories of Children Born Prematurely Before 32 Weeks Assessed With the Revised Brunet Lézine Scale at 1, 2 and 3 Years

This study will assess professionals in the CHI Créteil neonatal department and the Val de Marne perinatal network to gain a better understanding of the developmental trajectories of children hospitalized at the CHI Créteil, with a view to optimizing their care in the long term


Eligibility Criteria:
Inclusion Criteria:

* Children born at CHI Créteil between 2012 and 2022, included in the Val de Marne perinatal network.
* Children seen in pediatrician-psychomotor consultation with assessment by the BLR scale at 1 year AC.

Exclusion Criteria:

* Children born with a term of birth ≥ 32 weeks + 1 day.
* Child removed from the Val de Marne perinatal network monitoring from the age of 1 year AC: Death or parental decision.
* Children presenting with cerebral palsy, blindness or deafness at the age of 1 year AC.