cyrilzakka/clinical-trials huggingface dataset:
Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. In industrialised western countries, hepatitis E was until recently considered as imported from hyperendemic geographical areas, but is currently an emerging autochthonous infectious disease. A growing body of data from Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through direct or indirect exposure. Hepatitis E typically causes self-limited acute infection. However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be still higher in patients with underlying chronic liver disease. To date, no preventive or curative treatment of hepatitis E is available.

Therefore, the major goal of the study is to analyse for the first time the host responses in kidney-transplant recipients with chronic HEV infection and to compare them to the host responses in kidney-transplant recipients without viral infection (controls), to identify a specific peripheral signature using blood microarray-based gene expression profiling.

Other minor goals are :

1. to assess the incidence of HEV infection in kidney-transplant recipients from south-eastern France, to study the risk factors, and to describe the clinical features and outcomes of chronic HEV infection in kidney-transplant recipients,
2. to compare the peripheral signature to a liver signature in the cases where a liver biopsy is available. If peripheral and liver signatures are parallel, peripheral signature may become a non-invasive tool of exploration of chronic HEV infection in kidney-transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Transplanted by a functional kidney
* affected by a hepatitis E chronic
* Benefiting from a follow-up in the Center of Nephrology and renal Transplantation or in the service of Hépato-gastro-entérologie of the CHU The Conception in Marseille
* Having signed a consent informed about participation in the study

Exclusion Criteria:

* Affected by another sharp or chronic viral infection
Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia

Patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the Goodstrength trunk dynamometer.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists score 1-3
* Age equal to or above 18
* Ventral incisional hernia OR intact abdominal wall

Exclusion Criteria:

* Pregnancy
* Severe heart disease (New York Heart Association class III-IV)
* Severe pulmonary disease
* Severe musculoskeletal disease
* Systemic treatment with glucocorticoid
Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease

Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma, bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. However, while asthma is mostly characterized by obstruction due to bronchoconstriction of the airways, obstruction in bronchiectasis and CF originates primarily from mucus retention due to abnormal airway clearance mechanisms.

The Nitrogen Multiple Breath Washout test (N2-MBW-test) is a robust and sensitive detector of early pulmonary changes and ventilation inhomogeneity. The minimal cooperation which is required for this test makes it very convenient for use in any age category.

Research on LCI described it as a reliable indicator of obstructive lung disease in pediatric CF patients as from 6 years of age. Whether LCI is a reliable parameter for early lung disease in asthma children is less clearly demonstrated. No data were found on LCI calculated from the N2-MBW-test in children with bronchiectasis.

Subjects of all the intervention groups will perform three consecutive nitrogen multiple breath washout tests (N2-MBW-tests) when attending the Universitair Ziekenhuis Brussel (UZB) for their scheduled pulmonology consultation. Only the best measurement (based on LCI result) will be taken into account when comparing the groups. Every subject will be positioned in the same seated position.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable asthma
* Patients with non-CF bronchiectasis
* Patients with cystic fibrosis
* Aged 6-17 years
* FEV1 (%pred) \>50%
* Written informed consent from the parents or legal guardian

Exclusion Criteria:

* Unstable disease (e.g. pulmonary exacerbation, acute deterioration, acute asthma crisis)
* Patients mentally not capable to participate in the study
The Effect of GLP-1 on Postprandial Glucagon Secretion Independent of The Gastric Emptying Rate

Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent of the gastric emptying rate.

Aim: To investigate the glucagonostatic effects of glucagon-like peptide-1 (GLP-1) during prolonged and intermittent stimulation of the GLP-1 receptor independent of the gastric emptying rate. Glucagon concentrations will be measured following a liquid meal administered in duodenum at baseline and after exenatide, and liraglutide treatment.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
* \>18 years
* No residual beta-cell function (stimulated C-peptide \< 60 pmol)

Exclusion Criteria:

* Pancreatitis
* gastroparesis
* history of alcohol and/or drug abuse
* pregnancy and lactation
* other medical or psychological condition that made the patient unsuitable for study participation according to the investigators´ assessment
* contraindications to gastroscopy
* cancer (unless in complete remission \> five years)
Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis

The goal of this clinical study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC）in progressive pulmonary fibrosis. The main question it aims to answer are: • Determine the prognosis, health economics, and therapeutic strategy changes of patients with TBLC retrograde malleable pulmonary fibrosis. Participants will be randomly divided into two groups, and received TBLB or TBLC.


Eligibility Criteria:
Inclusion Criteria:

Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.

Exclusion Criteria:

Patients with platelet counts below 50,000×109/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC
Exhaled Breath Analysis in Human Subjects

Identification of exhaled breath pattern of human subjects

Breath analysis with mass spectormetry as a non-invasive method to identfy exhaled breath patterns.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years
* Informed consent

Exclusion Criteria:

* specific exclusion criteria for different subgroups
Metabolic Effects of Paricalcitol

The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).

Persons with chronic kidney disease (CKD) are at markedly increased risk of death, particularly from cardiovascular disease (CVD). A number of metabolic abnormalities may contribute to adverse health outcomes in CKD, including glucose intolerance, altered immune cell function, and oxidative stress. Each of these metabolic stressors is a known complication of CKD. Since these metabolic abnormalities are also known to contribute to the pathogenesis of cardiovascular disease, they are important potential therapeutic targets in CKD.

This study will test whether oral paricalcitol, an active form of vitamin D, will improve glucose tolerance, immune cell function, and reduce oxidative stress in people with stage 3-4 chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Estimated glomerular filtration rate of 15-59 mL/min/1.73m2
* Fasting glucose 100-125 mg/dL
* 18 years and older

Exclusion Criteria:

* Diagnosed with diabetes mellitus
* Use of diabetes medications (insulin or oral hypoglycemics)
* Prior dialysis or transplantation
* Planning to leave the area within 6 months
* Participation in another clinical trial within 30 days
* Treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks
* Serum calcium more than 10.2 mg/dL
* Pregnancy or breast-feeding
* Change in dose (within 8 weeks) of Fibrates, Niacin, ACE inhibitors, Angiotensin receptor blockers, Thiazide diuretics, Beta-blockers, Cholecalciferol or Ergocalciferol
* Incontinent of urine
* Cancer (other than skin cancer) within 5 years
* Tuberculosis
* Sarcoidosis
Safety, Tolerability and PK of SHR1314 in axSpA

The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.

This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The study originally planned to enroll 5 cohorts of 8 subjects each (N=40).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of axial spondyloarthritis (axSpA) and fulfilling the 2009 ASAS classification criteria.
2. Have a history of back pain ≥3 months with age at onset \<45 years.
3. Have active axSpA defined as BASDAI ≥4 at screening and baseline.
4. Have objective signs of inflammation by presence of elevated ESR and/or presence of elevated CRP.
5. In the past had an inadequate response to at least 1 or 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
6. If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.

Exclusion Criteria:

1. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
2. Previous exposure to other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
3. Total ankylosis of the spine.
4. Have recently received biologics, tumor necrosis factor inhibitors or other immunomodulatory agents within 12 weeks.
5. Have either a current diagnosis or a recent history of malignant disease.
6. Are pregnant or breastfeeding.
Combination of 68Ga-PSMA PET Data With Magnetic Resonance Spectroscopy Data (MRS) for Evaluating Prostate Cancer

Prostate cancer is the second most common cancer among man and the fourth most occurring over all . Characterization and management of the diagnosed prostate cancer is a challenging task due to its clinically and morphologically diversity. Clinically, this cancer range from indolent growing slowly malignancy, which does not threatened the patient life, to aggressive tumor that metastasize rapidly with very bad prognosis. Therapy of prostate cancer ranges from a "watch and wait" approach to hormone deprivation therapy to aggressive surgical, radiation, and cryosurgical therapies depending on the cancer characteristics. Prostate cancer is diagnosed using digital rectal examination, serum prostate-specific antigen (PSA) testing and transrectal ultrasonography (US)-guided biopsies . Imaging technologies have been adapted as a non-invasive method to obtain a comprehensive assessment of the disease. MRI is widely used and more specifically multiparameter MRI (mMRI) for detection, staging and tumor localization. mMRI uses multiphase modes including diffusion-weighted and dynamic contrast-enhanced imaging in addition to T2-weighted imaging to identify and classify cancer type . Magnetic Resonance Spectroscopy (MRS) is MRI technique that allow detection of tissue metabolic composition which is occasionally used to characterize prostate cancer, however is not used as a standard procedure. By suppression of water and fat signal, MRS sequence can detect relationship between lower concentration prostatic metabolites such as citrate, choline, creatine, and polyamines in the cell cytosol and in the extra cellular ducts.

Other imaging modalities used to characterize prostate cancer include ultrasound (US), computerized tomography (CT), functional imaging like bone scanning (BS) and hybrid imaging like choline based positron emission tomography and CT (PET/CT). However all of these modalities show disappointing sensitivity .

In recent years a new modality has emerged showing promising accuracy targeting the Prostate Specific Membrane Antigen (PSMA) which is significantly overexpressed in prostate tumor cells. By attaching radioactive isotope 68Ga to PSMA ligands, PET/CT molecular imaging can provide information regarding prostate cancer relapses and metastases with high contrast . Several recent studies showed the potential of 68Ga-PSMA PET in many application correlated with prostate cancer such as staging, identifying reoccurrence, guided biopsy and others . In the study, we wish to utilize the new hybrid PET/MR technology and combine 68Ga-PSMA PET studies with MRS information in order to explore correlation between the data obtained by both modalities and investigate the implication on the disease characteristics.

Eligibility Criteria:
Inclusion Criteria:

1.patients over the age of 18 with diagnosed prostate cancer at different stages of the disease.

Exclusion Criteria:

1. Patients younger than 18 years
2. contraindication to MRI or to intravenous gadolinium injection.
NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy

Treatment of non - tuberculosis mycobacteria lung disease is challenging. The current treatment used is from 2007 American Thoracic Society guidelines recommended antibiotic combination therapy, which is lack of validation of clinical studies. More and more studies have confirmed that NTM antibiotic resistant gene will affect the efficacy, such as erm(41), rrl to clarithromycin, rrs to amikacin and so on. This study aimed to compare the efficacy of guideline recommended therapy and optimized therapy according to antibiotic susceptibility - related genotype.Genetic testing is accomplished through GenSeizer's high-throughput gene capture technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007
* non-CF Bronchiectasis

Exclusion Criteria:

* Already on treatment for NTM lung disease
* Appropriate exclusion of other lung diagnosis
* Patients with severe organ dysfunction
A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100)

PARC is an international phase I/II trial evaluating the safety and activity of pegylated recombinant human arginase (BCT-100) in children and young people with relapsed/refractory leukaemia, neuroblastoma, sarcoma and high grade gliomas (brain cancers).

Currently the outcomes for these patients are poor and the therapeutic options are limited with a significant toxicity burden. Therefore new treatments which work in different ways to standard chemotherapy are urgently needed. Research has shown that arginine (a nutrient) is important in the survival of cancer cells. BCT-100 is a drug which can deplete arginine levels and starve cancer cells - a completely new approach. BCT-100 has been tested in adults and shown to be active with almost no side-effects. This trial will test whether this dose of BCT-100 is also safe and active in children with relapsed/refractory leukaemia, neuroblastoma, sarcoma and high grade glioma. The trial will also study how BCT-100 is broken down in the body and look for new biological markers of treatment response. Up to 64 children with relapsed cancers will be recruited over 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Aged 1- \<25 years old at the time of study registration
* Histologically confirmed disease in one of the following four groups:

  * Group 1 - Acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML)
  * Group 2 - Neuroblastoma Group 3 - Sarcoma
  * Group 4 - High grade glioma (as defined by 2016 WHO CNS classification)
* Radiological or laboratory evidence of disease progression (during or after completion of first line treatment) or any subsequent recurrence (biopsy at relapse is not mandated).
* Measurable bone marrow disease (group 1) or at least one evaluable radiological site of disease (group 2, 3 and 4).
* Adequate liver function defined as a total bilirubin ≤1.5x the upper limit of normal for age and ALT ≤ 3x the upper limit of normal for age
* Documented negative pregnancy test for female patients of childbearing potential within 7 days of trial entry
* Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 12 months following treatment discontinuation
* Written informed consent given by patient and/or parents/legal representative

Exclusion Criteria:

* Previous treatment with another therapeutic arginine depleting drug (bacterial or human) or arginase inhibitor
* Presence of any ≥ CTCAE grade 3 clinically significant treatment-related toxicity from prior therapies
* Pregnant or lactating female
* Evidence of uncontrolled infection
Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment

The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI (Fédération Dentaire Internationale) criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* Age: 18-65 years
* Indication Class I or II direct restorations in premolars or molars (Replacement of insufficient fillings due to secondary caries, fractures, insufficient marginal adaptation, loss of filling or primary caries)
* Cavity width must be at least half of the cusp tip distance
* Vital teeth, regular sensitivity
* Sufficient language skills
* No active periodontits
* Preoperative VAS (visual analogue scale) values \< 3 regarding tooth sensitivity and biting

Exclusion Criteria:

* Sufficient isolation of the cavity not possible
* Not completed hygiene phase or poor oral hygiene
* Missing antagonist, non-occlusion
* Missing tooth adjacent to the tooth to be treated
* Restorations replacing more than 1 cusp
* Caries profunda or very deep cavity
* Patients with a proven allergy to ingredients of the used materials (methacrylates) or local anesthetics (Articain, sulfite)
* Patients with severe systemic diseases
* Pregnancy
Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

This study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital kinematic biofeedback system against conventional in-person home-based rehabilitation, with the intent of reducing the need for face-to-face sessions.

The investigators hypothesize that the clinical outcomes of such a program will be at least similar to those of conventional rehabilitation.

Patients will be enrolled pre-operatively and then randomized into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform a 12 to 16-week rehabilitation program starting immediately after surgery.

Outcomes will be measured at baseline, 8 and 12 weeks. In patients where a decision is made to extend the program to 16 weeks, another assessment will be made at this point.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain and functional limitation with clinical examination compatible with rotator cuff tendinopathy
* Imaging (MRI or ultrasound) evidence of rotator cuff tear (supra and/or infraspinatus tendon tear inferior to 3 cm? or 5cm?)
* Indication for a simple rotator cuff repair according to the patient´s orthopedic surgeon
* Ability to understand simple and complex motor commands
* Availability of a carer to assist the patient after surgery

Exclusion Criteria:

* Patients admitted for revision cuff repair
* Complex cuff tears (involving subscapularis tendon or more than one tendon besides supra and infraspinatus, or massive dimension tears)
* Glenohumeral arthritis
* Irreparable tendon defect
* Patients with concomitant neurological disorders (ex. Stroke, Parkinson´s disease, multiple sclerosis)
* Aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process
* Respiratory, cardiac, metabolic conditions or others incompatible with at least 30 minutes of light to moderate physical activity
* Major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after surgery
* Other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program
* Blind and/or illiterate patients
Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis

The purpose of the study is to evaluate the effectiveness of four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 12 weeks.

(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients with Active Rheumatoid Arthritis who are Inadequate Responders to Methotrexate Therapy

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 and over
* Active rheumatoid arthritis (RA) diagnosed after the age of 16
* 6 or more swollen joints and 6 or more tender/painful joints from certain joints in the hands, wrists, arms and knees
* At least one of: positive result for rheumatoid factor test, either in the past or currently (blood test); x-ray showing bone erosion within the last 12 months; presence of certain antibodies in the blood (blood test)
* Currently taking methotrexate for at least 4 months (and on a stable dose for at least 6 weeks)

Exclusion Criteria:

* Females who are pregnant or breast feeding
* Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders.
* Previously taken, but not responded to, certain biological treatments for rheumatoid arthritis
* High blood pressure that is not controlled by medication
* Low levels of neutrophils in the blood (blood test).
Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography

The purpose of this study is to diagnose possible synchronous carcinomas and polyps with magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Two days before colonography, patients ingest a 200 ml Barium sulfate solution four times a day, which will render fecal masses "invisible" on the following MR colonography. The study is primarily a feasibility study with altered operative strategy as a secondary end-point. Gold standard is colonoscopy and operation.


Eligibility Criteria:
Inclusion Criteria:

* Obstructing colorectal cancer

Exclusion Criteria:

* Suspicion of IBD
* Pacemaker
* Metal in the body
* Claustrophobia
* Pregnancy