cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood Biomarker Analysis

The main goal of the BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis.

Study of the association between blood biomarkers and the presence of hepatic cytolysis, defined by AST and/or ALT above normal.

Eligibility Criteria:
Inclusion Criteria :

* Patient over 15 years old
* Diagnosis of Restricted Eating Disorders including Anorexia Nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Admission to Nantes University Hospital.

Exclusion Criteria :

* Chronic active viral hepatitis
* Hemochromatosis
* Other genetic, autoimmune.
* Treatment with a drug known to induce fatty liver disease (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals) unless the dose has been stable for ≥ 3 months
* Excessive alcohol consumption (≥ 30 grams per day in men, ≥ 20 grams per day in women)
* Pregnant, parturient or breast-feeding women, persons deprived of liberty, adults under legal protection or unable to express their consent, persons not affiliated or not beneficiaries of a social security scheme, persons under guardianship or curators
Virtual Reality After Breast Reconstruction Surgery

This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction. Study participants will receive specialized VR interventions, administered via VR headsets, to manage pain.

The primary objective of this study is to estimate the effect of utilizing VR on reducing opioid use in study participants undergoing mastectomy with implant-based reconstruction compared to the control group. Investigators will follow patients throughout the course of their hospitalization and monitor outcomes including pain levels, medication requests, and satisfaction.

Eligible participants will receive a VR headset and instructed to use the VR every time they feel pain and before asking for a pain medication. They can take pain medications, if they choose to do so. At their post-op visit, study participants will be interviewed and asked questions regarding their experience with VR.

Pain level and medication use will be compared with similar individuals who undergo the same procedure but are not provided with a VR headset.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Women who plan to undergo mastectomy and implant-based reconstruction
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
* Able to read and comprehend English

Exclusion Criteria:

* Current diagnosis of epilepsy, dementia, or other neurologic disease that may prevent use of VR headset and software
* Sensitivity to flashing light
* Diagnosis of motion sickness
* Pregnancy or a medical condition where the study participant is prone to frequent nausea or dizziness
* Current or recent (less than 6 months) use of opioids
* Individuals with psychiatric disorders, including those with delirium or other disorders that may involve hallucinations or psychosis
Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis

To study the efficacy of TCM as an effective supplement in addition to the traditional treatment in RA.

It is a prospective, double-blind, randomized, placebo-controlled study in patients with RA. It consists of a 24 - weeks period of randomized double-blind treatment of either TCM(Lingzhi and Sen Miao San)or placebo.

Primary outcome is assessed by showing a clinical response of at least 20% and 50% as defined by the American College of Rheumatology (ACR) criteria.Secondary outcome is defined as the changes in the number of swollen and tender joint counts, and the levels of ESR, CRP, the inflammatory markers, cytokine levels and oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilled the 1987 American College of Rheumatology (ACR) criteria for RA.
* The presence of 2 or more swollen or tender joints, based on 28-joint count.
* Morning stiffness lasting for 30 minutes.
* Erythrocyte sedimentation rate (ESR) of 28 mm/hour, despite treatment with disease modifying agent including MTX, sulphasalazine, hydroxychloroquine, auranofin or azathioprine were recruited into the study.
* Patients taking glucocorticoids (prednisone \< 7.5 mg/day) and/or nonsteroidal antiinflammatory drugs must have been taking a stable dosage for at least 4 weeks before entering the trial and were required to take the same dosage throughout the trial.
* Patients had radiographic erosive diseases.

Exclusion Criteria:

* Patients who are pregnant or nursing mothers.
* Severe liver disease (e.g cirrhosis, chronic active hepatitis)
* Renal impairment (serum creatinine level \> 150mmol/L)
* Known hypersensitivity to herbal medicine
Inspiratory Muscle Strength Training in Post-Covid Syndrome

Patients with post-Covid-19 syndrome are at high risk of developing cardiovascular diseases 12 months after acute infection of COVID-19. We recently revealed that these patients have elevated muscular sympathetic nerve activity (MSNA), vascular dysfunction, impaired cardiac diastolic function, and reduced functional capacity. Considering that these outcomes are independent predictors of cardiovascular mortality, it is urgent to restore the cardiovascular health of these patients. High resistance inspiratory muscle strength training (IMST) at 75% of pressure inspiratory (PImax) performed at home (5 min/session, 5-7 times/week per 6 weeks) reduces the MSNA, improves the endothelial function and lowers blood pressure in different populations. Based on these findings, IMST (75% PImax) is an excellent therapeutic option for patients with post-COVID-19 syndrome. Therefore, the aim of the present proposal is to test whether IMST (75% PImax) reduces sympathetic activity, improves vascular function, and restores cardiac function, evoking an increase in functional capacity in patients with post-COVID-19 syndrome. To test these hypotheses we will conduct a randomized, double-blind, sham-controlled clinical trial to test these hypotheses.


Eligibility Criteria:
Inclusion Criteria:

* Post-COVID-19 syndrome
* Have been diagnosed with COVID-19 by RT-PCR
* Have oxygen saturation ≤ 93% in room air during the acute phase of the COVID-19
* Have received oxygen supply from any device during the acute phase of the COVID-19
* Hospitalization to treat the Covid-19
* Participants in cardiopulmonary rehabilitation or physical conditioning programs

Exclusion Criteria:

* Pregnant
* History of chronic obstructive pulmonary disease or dependence on oxygen support
* History of cardiovascular and renal diseases and cancer prior to the COVID-19 diagnosis
* Difficulties in moving to the laboratory for assessments
Association Between Hepatitis C Infection and Renal Cell Carcinoma

The purpose of this study is to determine if there is an association between hepatitis C infection and kidney cancer. All patients who are diagnosed with kidney cancer and who will either have a biopsy or surgery will be offered to be tested for hepatitis C. The control group will be colon cancer patients. Both groups would be of recent diagnosis (6 months).


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years or older in whom renal cell carcinoma is suspected and are scheduled for either biopsy or partial or total nephrectomy. Diagnosis within 6 months.
* Male and female patients 18 years or older in whom colorectal cancer has been diagnosed within the last 6 months

Exclusion Criteria:

* Patients who are unwilling to provide consent
* Patients who decline to complete a questionnaire
* Patient in who blood sample cannot be obtained
* Diagnosis of renal cell carcinoma or colon cancer greater than 6 months
Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment

This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy.

Study Population:

Peri- and postmenopausal women with VVA, including breast cancer survivors.

Design: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group).

Vaginal Dilator : A silicone medical device will be used for gradual stretching progression. The kit includes dilators of progressively larger sizes.

Procedures: Assessments at baseline, at 4 \& 12 weeks

Measures : Vulvo Vaginal Atrophy severity , dyspareunia, Vaginal Health Index Score, Female Sexual Fonction Index, and Visual Analogue Scale (for vaginal dryness, vaginal and/or vulvar irritation/itching, and pain during sexual intercourse).

Statistical Analysis:

Differences at baseline, 4 weeks, and 12 weeks will be tested using:

Two-sample t-test Mann-Whitney test

Statistical Power:

Assuming a 20% improvement in Group 1 and 40% in Group 2, with:

p \< 0.05 (type I error) 80% power (type II error), 160 patients needed across both groups.

SoC = Standard of care RCT = Randimized control trial MHT = Menopausal hormonal therapy


Eligibility Criteria:
Inclusion Criteria:

* Peri- or postmenopausal women suffering from vulvovaginal atrophy (VVA)
* Breast cancer survivors with VVA symptoms
* Understand the study, be willing to participate, and sign an informed consent form.
* The use of estrogen/progestogen-based products (vaginal, oral, pellets, transdermal, etc.) is permitted but must be documented (this will be considered during randomization).

Exclusion Criteria:

* Undiagnosed abnormal genital bleeding.
* Administration of any investigational drug within 30 days prior to the screening visit.
* Presence of a serious medical condition, neurological disorder, or significant comorbidities.
* Other gynecological malignancies.
* Recent vaginal surgery.
* Clinically significant prolapse (POP-Q ≤ 2).
* Current urinary tract or vaginal infection, or recent sexually transmitted infection.
* Individuals with disabilities unable to communicate.
* Women eligible for the study but unwilling to participate.
gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas

Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival.

Multicentric, Randomized phase III study (1:1), Population: newly diagnosed 1p/19-codeleted anaplastic gliomas, Primary objective: To determine whether treating newly diagnosed 1p/19q-codeleted anaplastic gliomas with PCV alone can increase overall survival without neurocognitive deterioration Control group: radiotherapy followed by 6 cycles of PCV chemotherapy. Experimental group: 6 cycles of PCV chemotherapy (radiotherapy being deferred at the time of progression).

Number of centres participating: the 33 centers of the POLA network Recruitment duration: 7 years, the accrual rate being 40 patients per year, and patients are followed-up until the end of the trial.

Eligibility Criteria:
Inclusion criteria :

Histological confirmation of anaplastic glioma by central pathological review

* Tumor is co-deleted for 1p and 19q
* Age ≥ 18 years of age
* Newly diagnosed and ≤3 months from surgical diagnosis
* Willing and able to complete neurocognitive examination and the QOL
* Karnofsky performance status ≥ 60
* The following laboratory values obtained ≤ 21 days prior to registration:
* Absolute neutrophil count (ANC) ≥1500 /mm3
* Platelet count ≥100,000 / mm3
* Hemoglobin \> 9.0 g/dL
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* SGOT (AST) ≤ 3 x ULN
* Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
* Provide informed written consent

Exclusion criteria :

* Pregnant and nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of PCV.
* Received any prior radiation therapy or chemotherapy for any CNS neoplasm.
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.

Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged 3 years of age or older
* Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including:

  * Acute onset of sore throat;
  * Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation and;
  * At least one of the following:

    * Red and swollen/inflamed tonsils;
    * Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy
* ≤ 5 days from onset of signs and symptoms of pharyngitis
* Parent/legal guardian of Participants \< 18 years of age capable and willing to give informed consent
* Participants ≥18 years of age capable and willing to give informed consent

Exclusion Criteria:

* Participants \< 3 years of age
* Participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis
* Participants who have pharyngitis with clinical features that suggest a viral etiology such as, cough, runny nose, upper respiratory symptoms, and/or oral ulcers
* Currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent
* Participants 18 years of age or older unable to understand English and consent to participation
* Parent/legal guardian of Participants \< 18 years of age unable to understand English and consent to participation of child
Effects of Different Crystalloid Solutions for Extra-corporeal Membrane Oxygenator (ECMO) Priming

Crystalloid solutions modify acid-base equilibrium according to their electrolyte composition. Moreover, it has been suggested that these alterations are generated by the difference between the solution strong ion difference (SID) and the plasma bicarbonate level. An increased risk of acute kidney injury and renal replacement therapy has been associated to the infusion of chloride rich crystalloids. This study aims to compare, in patients with acute respiratory failure undergoing ECMO support, the effects on acid-base status and renal function of crystalloids commonly employed for circuit priming to a balanced solution created with a SID equal to patients' bicarbonate level.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Acute Respiratory Failure in need for ECMO treatment

Exclusion Criteria:

* None
Effect of Core Stability Exercises and Treadmill Training on Balance in Children With Down Syndrome

Introduction: Core stability exercises and treadmill training play a crucial role in physical therapy interventions and have an effect on balance in children with Down syndromes (DS), whether core stability exercises or treadmill training has more effect on improve balance has not been investigated yet. The aim of the study was to investigate the effect of core stability training versus treadmill exercises on balance in children with Down syndrome. Methods: Forty-five children with Down syndrome included in the study. The children aged 4-6 years, and they were equally divided randomly into three groups (A), (B) and (C). Group A received traditional physical therapy intervention strategies to facilitate the balance of participated children. Group (B) received same as the group (A), with additional core stability exercises training. Group (C) received same intervention strategies as group (A) in conjunction with a treadmill exercise program. The children's balance was evaluated using the Berg Balance Scale and the Biodex Balance System. Treatment sessions were for 60 min, thrice a week, for eight consecutive weeks.


Eligibility Criteria:
Inclusion Criteria:

* Able to recognize commands given to them,
* Able to understand our verbal command and encouragement, and
* Able to stand and walk independently without repeated falling

Exclusion Criteria:

* Any neurological or musculoskeletal disorders (signs of epilepsy and instability of atlantoaxial joint),
* Any mobility disorders
* Any cardiac anomalies
* Any vision or hearing loss
Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense as a Tool for Detection of Hypoglycemia

Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines an array of non-invasive sensors which monitors the patient's physiological parameters (heart \& respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch device.

The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to reference methods

The proposed study will be consisting of two main segments:

The primary aim of segment 1 of the study is data collection and calibration of the Hypo Sense sensor prototype compared to standard invasive reference glucometer.

The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance in detecting hypoglycemic events.

During the first segment of the study we intend to collect in parallel measurements of blood glucose using reference method (capillary glucometer) and continuous data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced.

The reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will translate the set of the physiological recorded parameters into detection of hypoglycemic events.

During the second segment of the study we intend to evaluate the validity of the Hypo Sense sensor ability to detect hypoglycemic events compared to standard invasive reference method (capillary glucometer).


Eligibility Criteria:
Inclusion Criteria:

* Signing an inform consent form prior to any trial related procedure
* Type 1 diabetes diagnosed at least 12 months prior to study inclusion
* Age \> 18 years old

Exclusion Criteria:

* Participating in other device or drug study
* Any significant disease or condition, including psychiatric disorders that in the opinion of the investigator is likely to affect patient's compliance or ability to complete the study
* Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
* Chronic skin problem in the lower inner arm
* Pregnant or breast feeding women
Augmenting Patching Treatment for Amblyopia With Physical Exercise

Researches are trying to establish whether moderate exercise enhances the treatment benefit of patching 2 hours a day for residual amblyopia in children.


Eligibility Criteria:
Inclusion Criteria:

* Aged 5 to \< 17 years old
* Cycloplegic refraction within past year
* Diagnosis of residual amblyopia, with no evidence of regression of amblyopic eye visual acuity by 1 or more LogMAR from best previous
* Completed at least 6 months prior patching treatment (minimum 2 hours/day) or atropine treatment.
* Stable visual acuity as defined by \<1 LogMAR change over 2 visits
* Xbox 360 Kinect, Wii or WiiU gaming system in the home, or a different gaming system with a version of Just Dance® already in the home.

Exclusion Criteria:

* Known problems with exercise tolerance
* No gaming system in the home that supports Just Dance® Kids 2014, and no existing version of Just Dance® in the home
* Current atropine treatment for amblyopia
The Effect of Insulin on Protein Metabolism After Cardiac Surgery

Background: The hyperinsulinemic-normoglycaemic clamp technique is a precise method of providing insulin and glucose while maintaining normoglycemia. High-dose insulin has profound effects on glucose and protein metabolism. It has been demonstrated in coronary artery bypass graft (CABG) surgery patients that high-dose insulin causes hypoaminoacidaemia. The investigators hypothesize that the reduction of plasma amino acids (AAs) levels as seen in patients undergoing CABG surgery and receiving high-dose insulin is a consequence of an inhibition of whole body proteolysis as assessed by L-\[1-13C\]leucine tracer kinetics.

Objective: The present study aims to investigate the effect of high-dose insulin therapy on whole body protein, glucose and end-organ metabolism in patients undergoing CABG surgery using stable isotope tracers \[6,6-2H2\]glucose, L-\[1-13C\]-leucine and L-\[2H5\]phenylalanine. The changes in the metabolic-endocrine milieu will also be evaluated by plasma concentrations of glucose, lactate, free fatty acids, prealbumin, albumin, fibrinogen, insulin, glucagon, and cortisol.

Methods: With the approval of local institution's ethical committee, 30 patients scheduled for elective will be enrolled. The patients will be divided randomly into two groups. The control group will receive a standard IV insulin protocol with the aim of keeping blood glucose \< 10 mmol/L. The treatment group will be administered a high dose insulin infusion of 5 mU/kg/min coupled with a variable infusion of glucose to maintain normoglycemia (4-6 mmol/L). Insulin infusion will be continued until the end of the study period approximately 8 hours after surgery. L-\[1-13C\]leucine and \[6,6-2H2\]glucose kinetics will be used to assess changes in whole body protein and glucose kinetics. Hepatic albumin synthesis will be determined by using primed continuous infusion of L-\[2H5\]phenylalanine. The preoperative measurements will be performed on the morning before the surgery. Postoperative studies will be conducted two hours after arrival in the intensive care unit. Tracer kinetics between the two groups will be analyzed using ANOVA for repeated measurements.

Significance: High-dose-insulin results in a significant reduction in plasma AAs in cardiac surgery. This study should address if this drop in plasma AA levels is secondary to a decrease in breakdown, an increase in synthesis or both during high-dose insulin therapy in open heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* ability to give informed consent

Exclusion Criteria:

* signs of severe malnutrition or obesity: body mass index (BMI) \< 20 or \> 30 kg.m-2, more than 10% involuntary body weight loss over the preceding six months, serum albumin \< 35 g.L-1
* chronic liver failure