cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e antigen(HBeAg)-negative or HBeAg-positive
* Subjects must have a treatment failure to their current nucleoside/ nucleotide treatment regimen
* Prior entecavir and/or tenofovir monotherapy is allowed
* Subjects must have compensated liver function

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Evidence of decompensated cirrhosis
* Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
* Moderate or severe renal impairment
* Recent history of pancreatitis
* Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of being assigned to study drug into this study
* Prior entecavir/tenofovir combination therapy
Certoparin in Renal Patients Undergoing Hemodialysis

This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to prevent clotting during hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring hemodialysis
* Patients requiring anticoagulation therapy during hemodialysis
* Written informed consent

Exclusion Criteria:

* Hypersensitivity to study medication
* Genetic abnormality or disease of clotting system
* Prior major surgery or bleeding
* Other protocol-defined inclusion/exclusion criteria may apply
The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease

The objective of this proposal is to investigate the acute effects of whole-body passive heat therapy using far-infrared technology on vascular function, exercise capacity, and renal function in CKD patients. The central hypothesis is that an acute bout of whole-body passive heat therapy will be well-tolerated and lead to acute improvements in large blood vessel (macrovascular) function, small blood vessel (microvascular) function, and exercise capacity without significantly altering markers of acute kidney injury.


Eligibility Criteria:
Inclusion Criteria for participants with CKD:

* Age \> 18 years old
* Stage 2-4 CKD

Exclusion Criteria for participants with CKD:

* Unstable medical conditions characterized by frequent or unpredictable biological, chemical, or psychological changes
* Uncontrolled hypertension
* Current fluid restrictions
* End stage kidney disease or currently on dialysis treatment
* Body weight \< 40kg
* Exhibits any contraindications to exercise as per ACSM guidelines
* Regular tobacco and/or nicotine use
* History of heat-related illness
* Participates in regular exercise and/or sauna use
* Current hormone replacement therapy
* Pacemaker or electro-medical implant
* Persons with or at risk of intestinal disorders including gastroporesis
* History of diverticula
* Persons who have undergone surgical procedures in the GI tract
* Swallowing disorders
* Chron's disease
* Current pregnancy
* Inability to provide informed consent
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors

The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed, locally advanced/unresectable or metastatic, well-differentiated Grade 1, 2, or 3 NETs of pancreatic origin or extra-pancreatic origin.
* Allowed prior lines of therapy, based on the site of NET and functional status.
* Documented radiographic disease progression per RECIST 1.1, as assessed by the Investigator based on imaging assessments (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) within 12 months before randomization.
* Measurable disease according to RECIST 1.1 as determined by the Investigator.
* Archival tumor tissue is required, if available. If archival tumor tissue is not available, a fresh biopsy may be submitted if it can be safely and feasibly obtained. Every attempt should be made to provide tumor tissue.

Key Exclusion Criteria:

* Histologically confirmed neuroendocrine carcinomas (including small cell lung cancer), medullary thyroid cancer, pheochromocytoma, paraganglioma, Merkel cell carcinoma, and mixed neuroendocrine non-neuroendocrine neoplasm (MiNEN).
* Prior treatment with a vascular endothelial growth factor receptor (VEGFR) -targeting tyrosine kinase inhibitor or a mammalian target of rapamycin (mTOR) inhibitor.
* Systemic chemotherapy and any liver-directed or other ablative therapy within 4 weeks before randomization.
* Systemic radionuclide therapy within 6 weeks before randomization.
* Radiation therapy for bone metastases within 2 weeks, any other radiation therapy, except as indicated above, within 4 weeks before randomization.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnant Women-Pilot Study

Pregnancy causes the development of biomechanical adaptations in the musculoskeletal system, especially in the lumbopelvic region. In this context, the thoracolumbar fascia (TLF) is the most important structure in this region and is an exoskeleton for the muscles of the lumbar region. However, it has not been objectively clarified how the TLF adapts to the changes in the lumbopelvic region during pregnancy. Therefore, the aim of this pilot study is to investigate the trimester-specific biomechanical (stiffness, decrement and tone) and viscoelastic (creep and relaxation time) properties of the TLF, which adapts to the lumbopelvic region changes in pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* First pregnancy
* They are between the ages of 18-40
* Pre-pregnancy Body-Mass-Index (BMI) \&lt; 30 kg/m2

Exclusion Criteria:

* Presence of connective tissue disease
* Deterioration of skin integrity in measurement areas
* Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal in biomechanical alignment
* History of spine, pelvis or lower extremity surgery or fracture in the past 6 months
* Description of chronic (more than 3 months) lumbar-pelvic region pain before pregnancy
* Defining metabolic disorders such as type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia
* Having Pelvic Girdle Pain
Neuro-ophthalmology and Autoimmune Encephalitis (NODE)

Autoimmune encephalitis represents a group of rare and heterogeneous neurological disorders. Pathophysiological mechanisms in these diseases are still unknown. Recently, oculomotor and neurovisual disorders have been described. Cerebral areas and neuronal networks associated with these abnormalities are well described. The investigator proposes to study and describe such neuro-ophthalmological disorders in a prospective cohort of patients with a autoimmune encephalitis, to better understand the pathophysiological basis of this neurological condition.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autoimmune encephalitis
* With or without pathological antibody
* Aged from 18 to 70 years old
* Able to understand the aims and methods of this project
* Non opposed to the participation of this study

Exclusion Criteria:

* Other neurological, psychiatric or systemic conditions, which could induce neuro-ophthalmological signs Cognitive impairment, which is not linked to autoimmune encephalitis
* Ophthalmological condition, which could modify the interpretation of neuro-ophthalmological data Inability to remain seated
* Pregnancy or breast feeding
* Adults under guardianship
Benefit of a Collaborative Approach to Improve the Quality of Medicines Use in Elderly Inpatients

The purpose of this study is to evaluate the impact of a collaborative approach (geriatric care involving the collaboration with a clinical pharmacist) to optimize the prescription of medicines for elderly inpatients.

Widespread evidence reveals frequent inadequate use of medicines in elderly patients. This includes inappropriate prescribing (overuse, underuse, misuse) that can lead to adverse drug events and drug-related admissions to hospital. In addition, when a patient is transferred from acute care settings to ambulatory care settings, discrepancies in medicines used often occur and can be hazardous.

Despite this, only limited data exist on the effectiveness of optimization strategies targeted at frail elderly inpatients.

Comparison: elderly inpatients receiving geriatric evaluation and management (GEM) care versus elderly inpatients receiving pharmaceutical care in addition to GEM care.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted on the acute geriatric unit of the university teaching hospital Mont-Godinne, Belgium

Exclusion Criteria:

* a terminal illness and life expectancy of less than 3 month
* expected length of stay of 2 days or less
* transfer from another unit where the patient had already been cared for by a GEM team
* refusal to participate
* inclusion during previous admission
* no time for the clinical pharmacist to compound the abstracted chart within 3 days of admission
Human Papillomavirus (HPV) Vaccination Acceptance by African-American Parents: Identifying Psychosocial Barriers

This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV vaccination among low-income, African-American teens.

The HPV vaccine offers hope that the incidence of cervical cancer can be greatly reduced in the U.S. and globally. However, because the vaccine is recommended for children and early adolescents, vaccine awareness and acceptance among parents is critical to insuring vaccine uptake and public health benefit. Although culturally specific concerns may reduce HPV vaccination among African-American youth, research has not addressed this possibility. Accordingly, the proposed study will enroll 300 mothers in a study to identify barriers to HPV vaccination among low-income, African-American teens. Surveys assessing culturally-specific barriers to HPV vaccination acceptance will be administered to both parents and their vaccine-eligible children. Upon completion of the survey, parents with vaccine-eligible daughters will be invited to receive a free HPV vaccination for their child through a local, teen-friendly health clinic. Outcome analyses will focus on identification of predictors of completed vaccinations among girls and barriers to vaccine acceptance among mothers of teenage sons. Our study will provide critically important behavioral outcome data linking barriers to vaccination to subsequent vaccination decisions in a real-world, health care setting.

Eligibility Criteria:
Inclusion Criteria:

* Females parent or guardian with an African-American daughter or son between the ages of 11 and 17
* African-American adolescents between the ages of 11-17
Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis.

The aim of this study is to compare the efficacy and safety of cefpodoxime 200 mg immediate (b.i.d) and cefpodoxime 400 mg modified release (q.d) tablet formulations in the treatment of acute bacterial rhinosinusitis.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older patients who have acute bacterial rhinosinusitis sign and symptoms (i, ii, iii) according to IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults: i. Onset with persistent symptoms or signs\* compatible with acute rhinosinusitis, lasting for ≥ 10 days without any evidence of clinical improvement, ii. Onset with severe symptoms or signs of high fever \> 39 and purulent nasal discharge or facial pain lasting for at least 3-4 consecutive days at the beginning of illness, iii. Onset with worsening symptoms or signs characterized by the new onset of fever, headache, or increase in nasal discharge that lasted 5-6 days and were initially improving.

   (\*Major symptoms: Purulent anterior nasal discharge, Purulent or discolored posterior nasal discharge, Nasal congestion or obstruction, Facial congestion or fullness, Facial pain or pressure, d Hyposmia or anosmia. \*Minor symptoms: Headache, Ear pain, pressure, or fullness, Halitosis, Dental pain, Cough, Fatigue)
2. Patients who are able to give culture sample from middle meatus (microorganisms to be teste: Streptococcus pneumoniae, Haemophilus influenzae \[including beta-lactamase producing strains\], Streptococcus pyogenes and Moraxella catarrhalis \[including beta-lactamase producing strains\]).
3. Patients who are able to use oral drugs,
4. If patient is a women of childbearing age; female patients who applies appropriate birth control,
5. Patients who have ability to communicate with investigators,
6. Patients who commits to adhere to the study protocol,
7. Patients who sign informed consent form.

Exclusion Criteria:

1. Patients who have hypersensitivity to beta-lactam antibiotics, penicillin and cefpodoxime,
2. Patients who hypersensitivity to peanut and soy,
3. Patients who have kidney or liver deficiency,
4. Patients who have history of more than 2 bacterial sinusitis episode within last 12 months,
5. Patients who have chronic sinusitis,
6. Patients who have history of head and neck surgery and/or severe sinusitis complication (brain abscess or venous thrombosis),
7. Patients who are hospitalized within 4 weeks prior to the start of study,
8. Patients who have immunodeficiency (i.e; HIV, corticosteroid use, immunosuppressive use),
9. Patients who used antibiotics within 30 days prior to the start of study,
10. Patients who need to use of antibiotics other than investigational drugs for concomitant disease,
11. Patients who used aluminium and magnesium containing anti-acids, probenecid and iron containing drugs within 2 weeks prior to the start of study,
12. Pregnant and lactating female patients.
Paracetamol and Patent Ductus Arteriosus (PDA)

The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.

Preterm neonates with a hemodynamically significant PDA will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1.po Paracetamol at a dose of 15 mg/kg every 6 hours at x 3 days or Group 2- IV indomethacin - 0.2 mg/kg/dose q 12h for three doses; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).Clinical staff will be blinded as to the study group assignment of the babies and since the group 1 drug is to be given every six hours, all babies will receive a parenteral substance every 6 hours. For Group 2 infants, the intermittent doses will be IV D5W alternating with drug.All infants will fed trophic feeds (20 cc/kg/day) during the treatment for ductal closure.

Eligibility Criteria:
Inclusion Criteria:

* Echocardiographic diagnosis of hemodynamically significant patent ductus arteriosus

Exclusion Criteria:

* Major congenital anomalies
* Life-threatening infection
* Active NEC and/or intestinal perforation
* Recent (within the previous 24 hours) intraventricular hemorrhage Grade 3-4
* Urine output \<1 ml per kilogram per hour during the preceding 8 hours
* Serum creatinine concentration of \>1.6 mg %
* Platelet count of \<60,000 per cc.
ALS Spinal Cord Gray and White Matter Study

This study aims to measure in vivo the spinal cord gray and white matter in patients with Amyotrophic Lateral Sclerosis and healthy persons that match the patients' age and sex using rAMIRA imaging, a novel Magnetic Resonance Imaging (MRI) method. Patients and healthy control persons prospectively undergo MRI examinations, clinical examinations including assessments of disability, and tests of muscle force using hand held dynamometry. Serum markers of neuro-axonal injury are also assessed.

Examinations for patients and healthy control persons are scheduled every six months over a time span of two years.


Eligibility Criteria:
Inclusion Criteria (patients):

1. 18 years or older
2. neurologist-confirmed possible, probable or definite ALS acc. to El Escorial criteria
3. at baseline: able to lie in an MRI scanner for one hour

Exclusion Criteria (patients):

1. active other neurological or neuromuscular condition explaining the symptoms or a significant part of it
2. other neurological or neuromuscular conditions interfering with the examinations
3. severe cervical spinal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study
4. other severe chronic disease
5. pregnancy
6. general contraindications against MRI scanning (e.g. metal implants, pacemakers)
7. not able to read the patient information due to language barriers (patient information in English and French may be provided)
8. major cognitive deficit impacting the ability to read and understand the patient information and/or to follow the instructions of the study personnel

Inclusion criteria (healthy control persons):

1. 18 years or older
2. able to lie in MRI scanner for one hour

Exclusion criteria (healthy control persons):

1. neurological or neuromuscular conditions
2. other severe chronic disease
3. pregnancy
4. general contraindications against MRI scanning (e.g. metal implants, pacemakers)
5. relevant cervical spinal canal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study
6. not able to read the patient information due to language barriers (patient information in English and French may be provided)

Inclusion criteria (patients with Motor Neuron Diseases other than ALS):

1. 18 years or older
2. neurologist-confirmed Motor Neuron Disease (not ALS)
3. able to lie in MRI scanner for one hour

Exclusion criteria (patients with Motor Neuron Diseases other than ALS):

1. other severe neurologic disease
2. other severe chronic disease
3. pregnancy
4. general contraindications against MRI scanning (e.g. metal implants, pacemakers)
5. relevant cervical spinal canal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study
6. not able to read the patient information due to language barriers (patient information in English and French may be provided)
Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

The aim of this study is to determine the principal factors that influence endothelial cell loss three month post cataract surgery.

Methods: Multi center observational Cohort study, inclusion period from 12/01/2022 to 10/06/2022. One hundred and seventy-five eyes of hundred and four patients who have appointment for cataract surgical indication were included. The percentage of corneal endothelial cell loss was quantified using specular microscopy before and 3 months after the surgery.

14 variables (pre-operative and intra-operative) that could be associated to endothelial cell injury were selected.

A bivariate analysis of relationship between these factors and endothelial cell loss at 3 months was performed by simple linear regression (Wilcoxon and Fischer tests). Multivariate analysis was performed by multiple linear regression in order to identify the factors independently related to endothelial cell loss.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cataract surgery
* Visual acuity monoyer scale \<8/10e (\> +0.2 logMar)
* Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification
* Covered by the social security scheme
* Have given their oral agreement

Exclusion Criteria:

* Corneal disease: keratitis, dystrophy or corneal degeneration
* Any disease of the anterior segment
* Low preoperative endothelial cell density \<1000 c/mm²
* Pregnancy, lactation
* Risk factors for surgical per-operative complication
* Uncontrolled ocular pressure
* Combined surgery (cataract with corneal graft, cataract with glaucoma surgery, cataract with vitrectomy, ....)
* Under legal protection
The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children

Respiratory diseases including Asthma are high prevalent among preschool children. Specific treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the amount of the drug reaching small airways and lungs is bigger how much smaller the particles liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg, that is supposed to reach the small airways at higher concentrations and be more suitable to patients who don't cooperate properly to the procedure of inhalation.

The investigators' group has reported successfully the possibility to perform Pulmonary Challenge tests (adenosine, methacholine and exercise) in tender age. Other studies reported relation between asthma control and reduction in airway hyperreactivity. The purpose of this study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways hyperreactivity in preschool children, as demonstrated by adenosine challenge test.

26 - 30 patients, between 3 -6 years old, mild asthmatics, with positive adenosine challenge test, will received in a randomized, double blind, cross over assignment Beclometasone dipropionate (100µg twice a day) or placebo, through an inhaler (autohaler) device, attached to a spacer device, during four consecutive weeks. Adenosine Challenge test will be performed another time at the end of this four weeks period. After 2 weeks with no medication (wash out period) the patients will receive the second intervention (beclometasone dipropionate or placebo) in a cross over manner and will be submitted to the last adenosine challenge test.

Clinical evaluation, resting spirometry and subjective evaluation through an analogical symptoms scale will be recorded in each visit.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of mild asthma
* children aged between 3 - 6 years old
* able to perform spirometry and adenosine challenge test
* positive challenge test at the time of inclusion
* without prophylactic treatment for asthma
* signed informed consent to join the research by the parents or legal tutor

Exclusion Criteria:

* other chronic diseases
* use of oral steroids in the last two months
* emergency room visit in the last two months
* pneumonia in the last two months
* impossibility to perform lung function tests
* disagreement of the parents or legal tutor
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease

Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease.

Methods: We accrued 25 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks.

Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects.

A difference of P \< 0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18 and Age \<=70.
2. Clinical diagnosis of meniere disease.

Exclusion Criteria:

1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
2. History of Otorhinolaryngology surgery.
3. Pregnant or lactating women.