cyrilzakka/clinical-trials huggingface dataset:
Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B

This is a multicenter, prospective, real-world study, recruiting patients with chronic hepatitis B under anti-viral treatment. The recruited participants will receive peginterferon alpha based regimen or nucleos(t)ide alone. The primary objective of this study is to compare the long-term outcomes (including hepatocellular carcinoma, decompensated cirrhosis, etc）of different anti-viral therapies. The secondary objective of this study is to compare the serological response rates of different anti-viral therapies, evaluate the predictive value of HBV-related laboratory testings and describe the kinetics of them results during antiviral treatment. The follow-up time course of this study will be 5 years.

The patients will be allocated into two cohorts based on the anti-viral treatment decided by their doctors. If they are going to take peginterferon alpha based regimen, they will be allocated in interferon cohort. If they are going to take nucleos(t)ide alone, they will be allocated in nucleos(t)ide cohort. The follow-up plan will be made by their doctors according to their conditions. No extra intervention or examination will be given in this study. The primary outcome is end-stage liver diseases including hepatocellular carcinoma and decompensated cirrhosis, and the rate of hepatocellular carcinoma and decompensated cirrhosis will be measure at 1 year，2 years，3 years, 4 years and 5 years from baseline. Secondary events including HBsAg loss, HBeAg conversion, fibrosis progression and fibrosis, which will be measured at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively. Results of laboratory testings will be recorded at each follow-up visit. The primary objective of this study is to compare the long-term outcomes (including hepatocellular carcinoma, decompensated cirrhosis, etc）of different anti-viral therapies. The secondary objective of this study is to compare the serological response rates of different anti-viral therapies, evaluate the predictive value of HBV-related laboratory testings and describe the kinetics of them results during antiviral treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with age ≥18; subjects who are over 70 years of age must be in generally stable health conditions.
* There should be evidences that HBsAg has been positive for more than 6 months or HBV-related histological changes.
* Planned to receive or already receiving anti-viral treatment with nucleos(t)ide including Entecavir, Tenofovir, and Tenofoviralafenamide. Or planned to receive peginterferon alpha 2b, either treated or treatment-naive.
* Agree to participate in the study and sign the patient informed consent form.

Exclusion Criteria:

* Currently treatment-related participating clinical trials.
Disease Progression in Women With X-linked Adrenoleukodystrophy

Observational, single-site prospective and minimally interventional study in women with X-linked adrenoleukodystrophy (ALD), conducted in France.

Patients accepting participation (after signing ICF) will be followed up to at least 2 years or until they started treatment for X-linked adrenoleukodystrophy (ALD) or withdraw consent, whichever occurs first. Follow-up will be extended beyond 2 years if deemed appropriate after an interim report. Tests and questionnaires will be assessed at baseline and yearly. If the study is extended, beyond 2 years, patients will be assessed at 1-year intervals.

At baseline visit and follow-up visits, patients will undergo an MRI of the brain and the spinal cord and assessments of body sway, EDSS, ADL, pain VAS and SF-36 questionnaire. Plasma biomarkers will be assessed from samples obtained through routine blood draw and a monthly falls diary will be provided each visit to be completed once a month.

This study will not assess any specific medicinal product or intervention, and the study will not interfere with that prescribed in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 years old or older.
2. Diagnosis of X-linked ALD based on genetic testing, altered VLCFA levels, or family history.
3. Willing to undergo annual follow-up visits, including brain and spinal cord MRI scans.
4. Provision of written informed consent.
5. Affiliation or beneficiary of a French social security system or of such a regime.

Exclusion Criteria:

1. Any condition that in the opinion of the investigator are likely to adversely affect the study participation, interfere with study compliance, or confound the study results.
2. Under treatment or previous treatment with leriglitazone.
3. Pregnant or lactating women.
4. Subjects benefiting from laws aimed at protecting vulnerable adults: subjects being deprived of liberty by judicial or administrative decision, subjects under guardianship.
5. Participation in an interventional clinical trial.
The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - RENEW Acute Study

This is a randomized controlled cross-over meal study with the overall aim to investigate the postprandial calcium absorption from calcium permeate compared with calcium carbonate. The hypothesis is that the bioavailability of calcium permeate is equal to or higher than calcium carbonate. This will be investigated in a cross-over design with 10 postmenopausal women age 50-65 as subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is \>50 years and \<65 years of age by the time of inclusion.
* Subject has been menopausal for 2-5 years.
* Subject willing and able to meet at University Hospital, Køge for three whole days in one month.
* Subject is non-smoking or able not to smoke during clinic visits.
* Subject with no history of osteoporotic fractures.
* Subject is willing and able to provide written informed consent prior to participation.

Exclusion Criteria:

* Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy.
* Subject with vitamin D insufficiency defined as ≤50nmol/l.
* Subject with an osteoporosis diagnosis.
* Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
* Subject with any serious illness e.g. cancer.
* Subject with lactose intolerance.
* Subject with celiac disease.
* Known or suspected abuse of alcohol or recreational drugs.
* Known or suspected hypersensitivity to trial products or related products.
* Subject where it is not possible to obtain sufficient data.
Blood Nitrate/Nitrite Concentrations Following Acute Ingestion of Resync in Men and Women

This study evaluates acute ingestion of the dietary supplement Resync on blood nitrate/nitrite concentrations in a sample of men and women. This will be a crossover trial in which participants take all 4 conditions: 1) 7.5g Resync, 2) 15g Resync, 3) 20g Resync+collagen, 4) placebo.

The product known as Resync contains a blend of nitrate-rich foods including beetroot, red spinach, turmeric, ginger root, and aronia berry extracts. Resync is sold commercially and marketed as an ergogenic aid and/or exercise recovery aid. Manufacturers of Resync recommend users take this product 60-90 minutes before an athletic event or 30-90 minutes after exercise. Resync bases these claims on prior studies investigating the individual ingredients' abilities to increase blood nitrate/nitrite levels; however, there are no clinical trials on the finished product itself.

The purpose of this pilot study is to determine the impact of acute, single ingestion of Resync products on blood nitrate/nitrite concentration in a sample of men and women. This will be a crossover trial in which participants take all 4 conditions: 1) 7.5g Resync, 2) 15g Resync, 3) 20g Resync+collagen, 4) placebo.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18 - 29.9 kg/m2
* Non-smoker
* Non-vegan
* Not using nitrate-based dietary supplements

Exclusion Criteria:

* Diagnosed history of diabetes
* Diagnosed history of cardiovascular disease
* Diagnosed history of neurological disease
* Pregnant females
Venetoclax Based Regimen for R/R T-ALL

This study is to investigate the therapeutic efficacy and side effect of venetoclax based regimen for relapsed or refractroy T cell acute lymphoblastic leukemia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 15 and ≤ 70 years.
2. Patients diagnosed with T-ALL/LBL according to 2017 WHO lymphoid malignant disease diagnosis standard.
3. Patients with T-ALL/LBL must meet one of the following criteria, A or B.

   A: Refractory T-ALL/LBL disease was defined as follows: Failure to achieve CR at the end of induction.

   B: Relapsed T-ALL/LBL disease was defined as follows: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR.
4. ECOG performance status score less than 3.
5. Expected survival time \>3 months.
6. Patients without serious heart, lung, liver, or kidney disease.
7. Ability to understand and voluntarily provide informed consent.

Exclusion Criteria:

1. Patients who are allergic to the study drug or drugs with similar chemical structures.
2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
3. Active infection.
4. Active bleeding.
5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
6. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
7. Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value).
8. Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
9. Surgery on the main organs within the past six weeks.
10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.
11. Patients who have received organ transplants (excepting bone marrow transplantation).
12. Patients not suitable for the study according to the investigator's assessment.
Escitalopram Neuroimaging Supplement

The purpose of this study is to find out more about the brain's response to selective serotonin reuptake inhibitor (SSRIs) treatment in people with body dysmorphic disorder (BDD). The investigators will use positron emission tomography (PET) and Magnetic Resonance Imaging (MRI) scans to look at brain activity in people with BDD before and after treatment with an SSRI. The investigators hope that what is learned will allow prediction of whether someone will improve with SSRI treatment.

The investigators have chosen to focus on five regions of interest, namely ACC, OFC, caudate, amygdala and hippocampus. These are brain regions that have been previously associated with obsessive-compulsive, affective, and psychotic phenomena. The investigators will test for correlations between pre-treatment FDG brain images and subsequent SSRI treatment outcome to identify potential predictors of treatment response. Finally, the investigators will compare pre-treatment and post-treatment PET FDG studies as well as MRI studies in BDD subjects to examine changes in these brain regions following treatment. The goals of the proposed research are to use FDG-PET and MRI to identify predictors of treatment response to SSRIs in BDD and to determine changes in rCMRglu in BDD subjects following treatment with SSRIs.

Eligibility Criteria:
Inclusion Criteria:

* male or female.
* from 18-64 years of age.
* right-handed, by virtue of assessment with the Edinburgh Handedness Inventory
* capacity to render informed consent.
* already enrolled in clinical study NCT00149799.
* must be an outpatient with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of BDD, as defined by DSM-IV criteria and by a BDD Yale-Brown Obsessive-Compulsive Scale Score greater than or equal to 24.

Exclusion Criteria:

* with serious medical illness or instability for which hospitalization may be likely within four months of entry into the study, or current renal insufficiency or diabetes.
* any pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded. Pregnancy status will be determined by administration of a blood beta-HCG test prior to each PET scan.
* with recent or anticipated radiation exposure, which, combined with the exposure in the present study, will exceed allowable annual limits for the subject
* with a history of hypersensitivity to any component of FDG
* with specific comorbid psychiatric diagnoses (alcohol abuse or dependence within the past 3 months, bipolar disorder, psychosis, organic mental disorder, development disorder, borderline personality disorder, body image concerns accounted for primarily by an eating disorder or weight concerns). If subjects have another comorbid diagnosis, the BDD must be the primary concern.
* MRI- incompatibilities (for example, metal implants, pacemakers)
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease

The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.


Eligibility Criteria:
Inclusion Criteria:

* Steroid dependent or refractory classic chronic GVHD disease.
* No more than 3 previous treatments for cGVHD.
* Receiving baseline systemic glucocorticoid therapy (at stable dose) for cGVHD at study entry.
* Men and women ≥18 years old.
* Karnofsky performance status ≥60.

Exclusion Criteria:

* Known or suspected active acute GVHD.
* Current treatment with sirolimus AND either cyclosporine or tacrolimus.
* History of treatment with a tyrosine kinase inhibitor (eg, imatinib), purine analogs or other cancer chemotherapy in the 4 weeks prior to starting study drug.
* Currently active, clinically significant cardiovascular disease.
* Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines or a recent infection requiring systemic treatment that was completed ≤14 days before the first dose of study drug.
* Progressive underlying malignant disease including post-transplant lymphoproliferative disease.
* History of other malignancy (not including the underlying malignancy that was the indication for transplant)
* Concomitant use of warfarin or other Vitamin K antagonists
* Known bleeding disorders or hemophilia.
* History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
* Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV).
* Concurrent use of a strong cytochrome P450(CYP) 3A inhibitor.
Pedaling Exercises for Disability and Activity Limitations

This purpose of this study is to determine the effect of different levels of feedback on participation in a home exercise regimen and the amount of walking performed by patients recently discharged from the acute rehabilitation setting.

The UCFit (University of California's U Cycle to Fitness) device is a standard commercial arm and leg restorator modified to collect pedaling data and to transmit it wirelessly to a central database, allowing for remote exercise monitoring. In this study, patients with stroke will perform pedaling exercise on the UCFit device prior to and then for a period of twelve weeks after discharge to home from inpatient rehabilitation. Differing levels of feedback will be provided to study subjects and corresponding changes in the amount of pedaling and walking performed will be identified. The results of this study will offer insight into the activity levels of disabled persons in their home environments. Furthermore, it will help in the identification of strategies that can increase activity levels in the critical period after discharge to home.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stroke
* no major contraindications to participating in light-to-moderate exertion
* able to follow and retain verbal directions to carry out simple lower extremity repetitive exercises
* planned discharge to home with family available to assist

Exclusion Criteria:

* pre-morbid limitations in walking related to another medical disease
* body mass index \>30
* fractures or contractures that prevent use of an extremity for pedaling
* impairment in cognition that precludes a full understanding of the risks and benefits of this study
Effect of Pulse Fractions on Indices on Cardiovascular Disease and Diabetes Risk Factors

The purpose of this study is to determine if whole and fractionated yellow pea flour, administered at USDA recommended dosages (50 g/day), improve risk factors associated with cardiovascular disease and diabetes.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 40 kg/m2
* Hypercholesterolemic

Exclusion Criteria:

* Smoking
* Use of prescription and natural lipid lowering therapies
* Myocardial infarction
* Coronary artery bypass
* Angina
* Congestive heart failure,
* Inflammatory bowel disease
* Pancreatitis
* Renal disease
* Diabetes
* Chronic alcohol usage (\> 2 drinks/day).
* Cancer
* Eating disorders
* Expending \> 4000 kcal/week through exercise
Japanese Phase 1 Multiple Ascending Dose (MAD) Study

The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese subjects and Japanese patients with depression (Hamilton Rating Scale for Depression (HAM-D) ≥ 14), ages 20 to 55 years.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Non-compliance, or overall not suitable as determined by the investigator.
* History of, or current clinically significant psychiatric disorders or illnesses, substance abuse or dependence.
The Effectiveness of Antimicrobial Breathing System on the Presence of Multidrug-resistant Organisms

The aim of this study is to investigates the effectiveness of antimicrobial breathing system on multidrug-resistant organisms (MDRO).

Background:

Cross transmission via skin contact and environmental media is the main route for common outbreak of health care-associated infection which more likely to be improved or prevented by infection control program. Silver Knight uses silver ions to disrupt the normal enzymatic activities of bacteria for reducing microbial growth within, and on, the surface of the breathing systems. It functions as a safe, quick and effective catalyst to deactivate pathogenic bacteria and prevent their proliferation. However, there was no study comparing the standard ventilator circuit with Silver Knight. This study focuses on the effectiveness of antimicrobial breathing system in MDRO which including carbapenem-resistant, vancomycin-resistant and multi-drug resistant.

Study Design:

This is a prospective, randomized study in a single hospital in the intensive care unit.

Methods:

In this study, we conduct a cluster-randomized crossover, single-centre trial. There are two groups:

1. Control group: standard ventilator circuit in odd number month.
2. Experimental group: Silver Knight in even number month This study is expected to recruit 200 subjects. During this period, the ventilator circuits are all routinely used, only the tubing will not be discarded after use for specimen collection.And the MDRO on the surfaces of ventilator circuits will be analyzed and evaluated.

Effect:

We expect the antimicrobial breathing system could be more effectively than the standard ventilator circuit. The policy related to current ventilator circuit will be revised according to the results of this study.

Key words:

Antimicrobial Breathing system, ventilator circuits, multidrug-resistant organisms (MDRO)

Eligibility Criteria:
Inclusion Criteria:

* mechanical ventilators in Medisive CareUnit (MICU)

Exclusion Criteria:

* Using ventilators for less than seven days
Assisting Low-Income Families at Pediatric Well-Child Care Visits

The objective of this study is to evaluate the impact and feasibility of a practice-based intervention on the discussion and referral of family psychosocial topics at well-child care visits at a medical home for low-income children.

Many low-income families have family psychosocial problems such as unemployment, housing difficulties, and food insecurity. Pediatric guidelines that pediatricians should be discussing and assisting these families. However, to date few routine do. The primary hypotheses for this study is that the WE CARE (Well-child care visit, Evaluation, Community resources, Advocacy, Referral, Education)intervention would increase the discussion and referral rates for family psychosocial problems at well-child care visits.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers of children aged 2 months to 10 years who present for well-child care visit at a pediatric clinic

Exclusion Criteria:

* Non-English speaking
* Foster parents
* Previously enrolled parent
* No access to telephone
A DERMO-EPIDERMAL AUTOLOGOUS SKIN SUBSTITUTE FOR FURTHER THERAPEUTIC USE

Innovative technologies in the emerging field of regenerative medicine might allow an improvement in the treatment of deep complex wounds leading to faster and better wound healing. Among them, the bioprinting technology, consisting in "printing human cells and biomaterials" to create a "dermo-epidermal substitute" that mimics an alternative of the physiological skin is the most promising alternative.

Besides improving skin substitutes properties, bioprinting allows to translate the manufacturing process of tissue-engineered products from manual, operator-dependent processes to a reproducible and automated solution. This paves the way to the manufacturing of therapeutic bioprinted products at the point of care, as close as possible from patients.

In this preclinical in vitro study, the investigators plan to generate GMP-compliant validation batches of "bio-printed dermo-epidermal substitutes" from 25 healthy volunteer patients' unused surgical tissue removed during plastic surgeries.

Volunteer's harvested tissue will allow to extract and then amplify the epidermal keratinocytes and dermal fibroblasts. Successive cultures and bioprinting steps will generate a "bio-printed dermo-epidermal substitute" in 2 or 3 weeks. A blood test may also be performed on the volunteers to characterize the genetic stability during the different stages of the process.

Eligibility Criteria:
Inclusion Criteria:

* Adult adult males or females
* Members of a social security scheme.
* No contraindications to general anesthesia
* Relevant to a plastic or repair surgery indication generating surgical waste.

Exclusion Criteria:

* Pregnant and/or nursing women
* Persons deprived of liberty
* Major under guardianship
* Persons unable to read the backgrounder.