cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules

In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups:

* one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age
* the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age

DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR 2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at birth. The duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age. Intervention name: Diphteria, tetanus, acellular pertussis, hepatitis B, poliovirus types 1, 2, 3 \& Haemophilus influenzae type b vaccine

Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Born after a normal gestation period (between 36 and 42 weeks).
* Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate.

Exclusion Criteria:

* Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose.
* Any chronic drug therapy to be continued during the study period.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements).
* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
* Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.
Multi-center Registry for CCSVI Testing and Treatment

Patients suspected of CCSVI (chronic cerebrospinal venous insufficiency) may be tested and if appropriate treated with catheter venoplasty by an interventional radiologist in their local community who has been credentialled either by the local hospital's IRB or a national IRB if the procedure is done in an outpatient facility. Catheter angioplasty is a long-established and accepted medical procedure, patients' insurance should but may not cover the testing or treatment.

more to follow

Eligibility Criteria:
Inclusion Criteria:

Referral by patients primary treating physician for suspected CCSVI

Exclusion Criteria:

Abnormal kidney function Allergy to either or both of the imaging contrast agents Pacemaker or other implantable device Ferrous metal in or on the body Claustrophobia Pregnancy

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COVID-19 Immunity and Changes Over Time

The risk of household spread of SARS-CoV-2 hinges on both the transmission dynamics of the virus circulating in the community as well as the seroprotection pattern of constituent members, which can be attributed to vaccination and previous infections. This study is conceptualised to assess the dynamicity of SARS-CoV-2 risk at the household level, through monitoring the pattern of seroprotection, in conjunction with the vaccination coverage, history of infection and exposure risk in the setting of Hong Kong.

The aim of this study is to assess the SARS-CoV-2 risk at the household level, with the objectives of (a) determining the coverage of vaccination and its changes over time; (b) monitoring pattern of exposure and history of infection; and (c) evaluating the level of seroprotection and its longitudinal trend.

A cohort of households comprising 900 persons would be recruited. Invited participants would be attend the Research Centre for blood sampling and the completion of a simple questionnaire at 3 different timepoints at 12-18 months apart. A questionnaire would be administered to capture the following characteristics: (a) Socio-demographics; (b) History of SARS-CoV-2 infection; (c) adoption of precautionary measures; (d) SARS-CoV-2 testing history and (e) SARS-CoV-2 vaccination uptake.

Participants would be tested for SARS-CoV-2 serology. The main markers for measurement are nucleocapsid antibody for inferring past infection, spike antibody for the immunological responses, and seroprotection by SARS-CoV-2 surrogate virus neutralisation test.

Eligibility Criteria:
Inclusion Criteria:

* adults of age 18 or above, or children under the age of 18 with informed consent of the legal guardian
* normally residing in Hong Kong
* could communicate in spoken and written Chinese and/or English

Exclusion Criteria:

* individuals with mental illness
* prisoners
Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation

We assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse remodeling of the left ventricle (LV) in the postoperative period. It is suggested that functional mitral regurgitation (MR) provides supra-physiological left ventricle volume overload and this fact plays positive role in early-stage post-operative left ventricle volume and function recovery. LV volume, systolic and diastolic function will be monitored with echocardiography (EchoCG) along with life quality in patients with different grades of functional mitral regurgitation secondary to severe chronic aortic insufficiency after surgical treatment of aortic regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Planned primary elective surgery for chronic aortic regurgitation
* Presence of functional mitral regurgitation
* End-diastolic volume of the left ventricle \&gt;= 250 ml

Exclusion Criteria:

* Infectious endocarditis
* History of myocardial infarction
* Indications on simultaneous myocardial revascularisation
* Acute aortic regurgitation of any etiology
* Previously diagnosed dilatation of the left ventricle, not associated with the development of aortic regurgitation
* Long-term persistent or permanent form of atrial fibrillation
* Pregnancy in the first 12 months after surgery
* Simultaneous participation in other studies
* Presence of implanted pacemakers
* Refusal to sign informed consent
* Acute coronary event diagnosed within 12 months after aortic valve surgery
* Indications for resynchronization therapy or permanent right ventricular pacing in the first 12 months after aortic valve surgery
* Re-do cardiac surgery for any reason within 12 months after aortic valve surgery
Study of A New Contact Lens Cleaning and Disinfecting Solution

The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be habitual wearers of one of the protocol specified lenses.
* Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses.
* Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must agree to wear their lenses on a daily wear basis for approximately three months.

Exclusion Criteria:

* Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution.
* Subjects who currently wear Opaque Cosmetic Tint Contact Lenses.
* Subjects who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Subjects with any systemic disease currently affecting ocular health or which in the Investigator"s opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator"s opinion, affect ocular physiology or lens performance.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator"s judgment, interferes with contact lens wear.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea.
* Subjects who are allergic to any component in the study care products.
Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease

Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to coronary artery disease (CAD).Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even in the absence of hypertension .It is a strong predictor of cardiovascular events and all-cause mortality .

Sitagliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), may regress left ventricular mass (LVM) in newly diagnosed type 2 diabetic patients with CAD .


Eligibility Criteria:
Inclusion Criteria:Patients had to have the levels of hemoglobin A1c (HbA1c) \> 7.0 %. They also had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction. In addition, they were also required to have an office BP \< 135/85 mm Hg and the presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index \[LVMI\] \> 115 g/m2 for men and \> 95 g/m2 for women) . -

Exclusion Criteria:Patients were excluded if they were currently prescribed glucagon-like peptide (GLP) -1 analogues or DPP-4 inhibitors or glucosidase inhibitor or anti-hypertensive drugs (including b-blockers), diabetes medications, estrogen supplements, thyroxine, diuretics, hypolipidemic drugs. They were also excluded if they had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent. Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women. -
Comparison of 2 Tests to Diagnose Cognitive Dysfunctions in Alcohol Disease

The objective of this study is therefore to compare the results obtained with these two screening tests, using as gold standard the results obtained by the battery of neuropsychological reference tests.

Recently, a new screening test for cognitive disorders was specifically developed for patients with UAS: BEARNI (Brief Evaluation of Alcohol-Related Neuropsychological Impairments). Since the BEARNI is presented as the reference test, the investigators have systematically proposed it to hospitalized patients, in combination with the usual check-up. In practice, at admission, patients were therefore given two screening tests, the MoCA and the BEARNI. In the event of an anomaly in at least one of these tests, a battery of confirmatory neuropsychological tests was performed.

Eligibility Criteria:
Inclusion Criteria:

* patients with alcoo use desorder
* Patient cared for in the addictology department of the University Hospital of Nîmes

Exclusion Criteria:

* refusal to use the data
Prediction of the Effect of Fluid Administration Using Arterial Pressure and Ventilator Data During Abdominal Surgery

It is well known, that patients with circulatory impairment sometimes, but not always, benefit from intravenous fluids. Predicting if a fluid administration will improve circulation is therefore of substantial clinical interest.

Ventilator treatment induces cyclic variation in blood pressure due to interaction between the lungs and the heart. This variation is minor, but its amplitude may be used for guiding fluid administration.

However, this method of using ventilator-induced variation in blood pressure to predict the effect of fluid administration was developed when different settings for ventilator treatment was recommended, compared with today. With today's recommend ventilator treatment, the method is, unfortunately, less reliable.

The investigators will investigate how different ventilator settings influence variation in blood pressure, and the investigators will test if this knowledge allows us to better predict the effect of a fluid administration, by taking the ventilator settings into account.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled open abdominal surgery.
* Scheduled treatment with Aarhus University Hospital's goal-directed therapy protocol (hemodynamic monitoring).

Exclusion Criteria:

* Left ventricular ejection fraction ≤ 40 %
* Irregular heart rhythm (e.g. atrial fibrillation or frequent ectopic beats)
* Known right ventricular dysfunction (if reported qualitatively in pre-operative assessment or objectively via Tricuspid Annular Plane Systolic Excursion (TAPSE) \< 17 mm)
* Pregnancy
* Prior participation in this study
A Phase 1, Dose-Escalation, Positron Emission Tomography Study to Assess the Safety, Pharmacokinetics, Dosimetry and Biodistribution of GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers

This is a Phase 1, single-center, open-label, single-arm, dose-escalation positron emission tomography study to assess the safety and tolerability, immunogenicity, Pharmacokinetics, dosimetry, and biodistribution after GEH200521 (18F) Injection is co-administered with GEH200520 Injection in healthy volunteers.

The estimated study duration for each subject is approximately 28 days.

The primary study objective is to evaluate the safety and tolerability of the IMPs, the selected mass doses of GEH200520 Injection co-administered with a fixed dose of GEH200521 (18F) Injection.


Eligibility Criteria:
Inclusion Criteria:

* The subject is able and willing to comply with all study procedures as described in the protocol, and has read, signed, and dated an informed consent form prior to any study procedures being performed.
* The subject is male or female ≥18 years of age.
* The subject has a body mass index (BMI) ≥18 and ≤35 kg/m2.
* The subject has no history of chronic medical illness or symptoms of active illness per Investigator's assessment.
* The subject has no clinically significant deviation from normal ranges in physical examination, ECG, and clinical laboratory parameters.
* Female and male contraception methods.

Exclusion Criteria:

* Subject is using prescribed and/or non-prescribed medication which in the Investigator's opinion might impact subject safety or the study results.
* Subject has a known or suspected allergy to IMP and/or IMP ingredients.
* Subject has had a surgery within 8 weeks prior to enrollment or a surgery is scheduled during the study.
* Subject has been enrolled in this or another interventional clinical study within the 30 days before screening for this study or is actively participating in another clinical study with IMP(s).
* Subject has been enrolled in another clinical study with radiation or exposed to radiation due to medical practice, which in the Investigator's opinion might impact subject safety or the study results.
* Subject is pregnant, planning to become pregnant, or is lactating.
* Creatinine and liver function laboratory values higher than 1.5x upper limit ranges per local site clinical practice.
Role of LILRA3 in Ankylosing Spondylitis and Axial Psoriatic Patients

1. To evaluate the frequency of LILRA3 in Ankylosing spondylitis and Axial psoriatic arthritis patients.
2. To investigate the association of LILRA3 with Ankylosing spondylitis and Axial psoriatic arthritis disease activity and severity.

Axial spondyloarthritis (axSpA) is a complex inflammatory condition that affects the axial skeleton including the sacroiliac joints and the spine (1). It also affects peripheral joints and can be associated with extra-musculoskeletal manifestations including uveitis, psoriasis, and inflammatory bowel disease (1).

Axial spondyloarthritis include ankylosing spondylitis (AS), certain forms of psoriatic arthritis (PsA), reactive arthritis with axial involvement, and arthritis associated with inflammatory bowel disease (2).

The diagnosis of axSpA remains very challenging with years of delays attributed to several different factors. There is also a strong need to identify new serological biomarkers that can aid clinicians for diagnosis of axSpA.

Leucocyte immunoglobulin-like receptor A3 (LILRA3) belongs to a family of leucocyte receptors produced as a soluble molecule by monocytes and macrophages. (3) The function of LILRA3 remains obscure, but LILRA3 could bind to HLA class I molecules HLA-G and HLA- C (4) and may act as an antagonist on other LILRs or a soluble ligand to other receptors(5) Growing evidence shows that (LILRA3) is associated with many autoimmune disorders.(6) (7) The functional LILRA3 is a susceptibility factor for AS and axial psoriatic arthritis (axPsA) has not been investigated.

Eligibility Criteria:
Inclusion Criteria:Adult AS and axPsA patients \<18 years Who fulfilled the Assessment of SpondyloArthritis international Society (ASAS) criteria for axSpA.

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Exclusion Criteria:1-patients less than 18 years old

2-Individuals with other autoimmune diseases

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PK and PD Study After Single Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects

The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a single-dose intravenous administration of 100 IU/kg in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Agree to all the purposes of the study by signing and dating the Informed Consent;
* Male, aged between 20 and 55 years, clinically healthy;
* BMI between 18.5 and 30;
* Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
* VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells.
* Human serum ferritin between 36-262 mcg / L;
* Counting of reticulocytes in peripheral blood ≤ 3%;
* Serum erythropoietin \< 30 mIU / mL.

Exclusion Criteria:

* Participation in clinical trials in the 12 months preceding the survey;
* Body weight \> 100 kg;
* Presence of iron deficiency anemia;
* Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
* Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
* Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
* Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study;
* Administration of any drug in the 02 weeks prior to the start of the practical period of the study;
* Clinical history of autoimmune or hereditary anemia;
* Clinical history of chronic bleeding;
* Clinical history of acute bleeding in the 30 days preceding the beginning of practical phase of the study (administration of the drug);
* Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation;
* Current or previous history (less than 12 months) of illicit drug abuse and / or tobacco and / or alcohol or having consumed alcohol within 48 hours prior to the practical study periods (administration of the drug);
* Prior therapies with erythropoietin;
* Albumin below 3.5 g/dL or higher than 4.8 g/dL;
* Signs or clinical history of bone marrow aplasia;
* History and clinical or laboratory liver disease;
* History and clinical or laboratory nephropathy;
* Principal Investigator of the study criteria.
Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD

A French multicenter randomized and double blinded shamed controlled study recruiting patients who present resistant PTSD. The aim of this trial is to assess the efficacy of cerebral modulation by rTMS with simultaneous reactivation of traumatic memory on the PTSD symptoms at M1.

Detailed Description : PTSD is considered as one of the top 10 public health concerns. Most patients with PTSD receive pharmacologic treatment and traumatic reactivation therapy. However, to date, the optimal treatment alternatives for non-responders PTSD patients are unknown.

Functionally, the metabolic activity of the prefrontal-amygdala cortex circuit in PTSD is significantly altered. Repetitive Transcranial Magnetic Stimulation (rTMS) provides focused, non-invasive stimulation of cortical areas of the central nervous system and could correct cortical defective activation of the prefrontal cortex seen in PTSD Patient (FDA has already approved rTMS for depression and acoustic-verbal hallucinations treatment).

Pairing rTMS with cues relevant to the trauma may be a novel approach to treat PTSD patient.

The study will enroll 102 subjects with resistant PTSD. After screening and inclusion phase, the treatment phase with 12 sessions of rTMS and simultaneous reactivation of traumatic memory or sham rTMS and simultaneous reactivation of traumatic memory will be performed (3 to 4 weeks). Antidepressant treatment will be maintained. The follow up phase consist of 3 visits at M1, M3 and M6 to follow the evolution of the PTSD symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years.
* Presenting a PTSD according to DSM-5 criteria
* Patient with persistent symptoms (PCL-5\>40) after a 6 weeks treatment with labelled antidepressant for PTSD (paroxetine or sertraline)
* Patient with health insurance (AME excepted)
* Signed written inform consent

Exclusion Criteria :

* Contraindication for rTMS:

  * History of epilepsy or seizure
  * Cochlear implants
  * Cardiac pacemaker or intracardiac lines, or metal in the body
* Patient has already had a rTMS session and/or Electroconvulsive therapy (ECT) and/or Transcranial direct current stimulation (tDCS)
* Ongoing PTSD-oriented cognitive-behavioral therapy
* Lifetime psychotic or bipolar disorder or antisocial personality or borderline personality
* Brain injury defined by medical report (including cortical and subcortical atrophy, dementia, stroke, transient ischemic attack and head trauma)
* Current substance dependence (including alcohol, excluding tobacco);
* Acute suicidal ideation
* No adequate mastering of the French language or no ability to consent
* Pregnancy (confirmed by a urine test beta-HCG) or breast feeding or absence of birth control
* Patient under legal protection measure and or deprived of freedom
* Participation in any other interventional study or in the exclusion period any other interventional study