cyrilzakka/clinical-trials huggingface dataset:
Burosumab and 1-25 (OH) Vitamin D on Human Osteoclasts

Fibroblast growth factor 23 (FGF23) is the cornerstone of phosphate / calcium / vitamin D metabolism: it is synthesized mainly by osteocytes and acts as a Phosphating agent, inhibitor of dihydroxyvitamin D, and inhibitor of synthesis and secretion of Parathyroid hormone (PTH) in most tissues.

The specific role of FGF23 on bone has yet to be demonstrated. In some diseases such as hypophosphatemic rickets (HR), the direct role of FGF23 on bone has not yet been studied to our knowledge, whereas these genetic hypophosphatemias are secondary to overexpression of FGF23, whether an activating mutation of FGF23 or inhibitory mutations of its inhibitors (Dentin matrix acidic phosphoprotein 1 (DMP1) and Phosphate-regulating neutral endopeptidase, X-linked (PHEX)). However, patients with X-linked hypophosphatemic rickets (XLH) have higher circulating FGF23 levels than healthy controls and these levels are higher in treated patients.

Management of XLH consists primarily of correcting the native vitamin D defect by prescribing active vitamin D analogs as well as phosphate supplementation to improve bone mineralization and decrease dental complications, growth, and bone deformities. Recently, a new therapeutic option has been developed for XLH, burosumab, a human monoclonal antibody that binds and inhibits FGF23 activity. The use of burosumab is currently authorized in France in some pediatric patients with severe forms of XLH.

Independently of the indirect bone effects of phosphate correction and vitamin D levels, the direct role of burosumab on bone cells has never been studied. The objective of this project is to study the osteoclastic biology of patients with HR compared to control patients, and to evaluate the direct impact of the treatments used in this pathology on human osteoclasts.


Eligibility Criteria:
hypophosphatemic rickets patients:

Inclusion Criteria:

* children from 2 yars-old to 18 years old and adults
* patients with HR followed in the center of calcium and phosphorus metabolism rare diseases in Lyon-
* Patients and parent / holder of parental authority who have been informed of the study and do not object to participate

Exclusion Criteria:

* Patient being treated with oral corticosteroid or having received more than 3 months of corticosteroid treatment before surgery.
* Patients under tutorship or curatorship
* Pregnant and / or breastfeeding woman
* Patient deprived of liberty

Controls patients:

Inclusion Criteria:

* children from 2 years-old to 18 years old and adults
* patients with normal renal function (Schwartz glomerular filtration rate (GFR) \>90 ml/min/1.73m²)
* Patients and parent / holder of parental authority who have been informed of the study and do not object to participate

Exclusion Criteria:

* Patient being treated with oral corticosteroid or having received more than 3 months of corticosteroid treatment before surgery.
* Patients under tutorship or curatorship
* Pregnant and / or breastfeeding woman
* Patient deprived of liberty
* Patient treated with immunosuppressive drugs
* Patient with inflammatory disease
Impact of an Intervention Integrating the MPHS Nursing Model of Care on the Partnership in Health, With the Patient Followed in Primary Care by an Advanced Practice Nurse (APN) for One or More Stabilized Chronic Pathologies

The WHO and our governance advocate that health professionals should organize care around the patient, considering his or her values, needs and preferences, and enabling the patient to develop the capacity to self-manage the chronic health problems he or she faces. Chronic disease is an ongoing dynamic process and adaptation to this process is complicated by the interaction of several determinants: self-management capacity, level of health literacy, quality of life and experience of care. To best support chronic disease, the recommendation is to adopt a management strategy that allows chronic patients to play an active role in the management of their condition and in the day-to-day decision-making process. The management of chronic pathologies is one of the specialties in which Advanced Practice Nurses are positioned, in primary care, outside hospital. Nursing care benefits from care models that allow for more adapted responses, regarding particular care situations, or certain patient typologies. The Humanistic Partnership Health Care Model (MPHS) implement in current Advanced Practice Nurse (APN) practice.

The IMPACT program proposes to integrate the MPHS model into primary care, within advanced practice nursing care, to strengthen the partnership of the patient with chronic disease. This model will allow the advanced practice nurse to co-construct with the patient partner a care trajectory that will be integrative, considering his aspirations and priorities to carry out his life project, while coping with his chronic pathology(ies). To do this, particular attention to the determinants of adaptation to chronic disease: self-management capacity, health literacy, quality of life and experience of care is pay.

The IMPACT program will use the theoretical framework of the MPHS model of care to structure the advanced practice nursing care management and will incorporate validated measurement tools to address the determinants of patient adaptation to chronic disease. The specific management of the IMPACT program will consist of 3 phases: (1) co-definition of the health situation, (2) co-planning of care and co-actions, and (3) co-assessment with the patient and the team caring for him/her.

Eligibility Criteria:
Inclusion Criteria:

* Followed by APN, within the framework of an organizational protocol established with a patient's referring physician, for the management of one or more chronic pathology(ies) from the following list: stroke; chronic arterial disease; heart disease, coronary artery disease; type 1 diabetes and type 2 diabetes; chronic respiratory failure; Parkinson's disease; epilepsy
* Affiliated or entitled to a social security plan
* Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study

Exclusion Criteria:

- Patient not referred by a physician for APN follow-up
Clinical Trial of Safety and Immunogenicity of Recombinant SARS-CoV-2 S-Trimer Vaccine (CHO Cells) as Booster Vaccination in Populations Aged 18 to 59 Years

Increased immune escape of emerging SARS-CoV-2 variants and waning neutralizing antibody levels over time indicate the importance of COVID-19 vaccine booster dose. Preclinical findings have shown that the recombinant SARS-CoV-2 S-Trimer vaccine exhibited favorable safety and immunogenicity. Herein, we conducted a randomized, open-label, positive control trial to assess the safety and immunogenicity of the booster shot in healthy subjects aged 18-59 years who have completed two-dose primary series of inactivated vaccine for 6-15 months. A total of 63 eligible participants were enrolled to receive the recombinant SARS-CoV-2 S-Trimer vaccine or inactivated vaccine, and only one participant in 30 μg recombinant SARS-CoV-2 S-Trimer vaccine cohort withdrew owing to personal work reasons on September 26, 2022. Subjects in each dose group (5 μg, 10 μg, 30 μg recombinant SARS-CoV-2 S-Trimer vaccine) was randomly assigned to receive the experimental vaccine or inactivated vaccine in a 2:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were those who completed the two-dose primary series of ICV for 6-15 months
* Voluntarily consented to participate in this trial
* Agreed to take effective contraceptive measures (women of childbearing potential) from signing the informed consent form to 12 months after booster vaccination.

Exclusion Criteria:

* History of allergy to any vaccine or its excipients;
* Presence of severe, uncontrollable or hospitalized diseases;
* History of major surgery within 3 months prior to enrollment;
* History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or COVID-19;
* Congenital or acquired immunodeficiency or autoimmune disease;
* Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrollment;
* Receipt of any COVID-19 prophylactic medication other than primary series of ICV;
* Long-term receipt (\>14 consecutive days) of glucocorticoids or other immunosuppressive agents within the past 6 months;
* Receipt of biological agents, immunopotentiators or immunosuppressants within the past 6 months;
* Receipt of blood or blood-related products within 3 months prior to vaccination;
* Administration of antipyretics, painkillers or antiallergics within 24 hours prior to vaccination;
* Participating or planning to participate in other clinical trials during the study period;
* Pregnant or lactating females, women of childbearing age of pregnancy test positive;
* Presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.
Arthroscopic Partial Meniscectomy Time Window

The purpose was to assess knee function outcomes between early arthroscopic partial meniscectomy(APM) and delayed APM for patients with degenerative meniscus lesions(DMLs)

Whether early APM surgery or delayed APM surgery will more benefit for patients with DMLs. The study was to determine the early APM vs delayed APM effect on knee function outcomes for patients with DMLs for 1 year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* • Clinical diagnosis of degenerative meniscus lesions based on knee MRI

Exclusion Criteria:

* • Must be able to have no acute knee injury such as car crash or acute sports injury;

  * Must be able to have no knee surgeries history;
  * Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
  * Must be able to have no contraindications to MRI;
  * Must be able to have no severe cardiopulmonary disease;
  * Must be able to have no musculoskeletal or neuromuscular impairments ;
  * Must be able to have good visual, hearing, or cognitive;
Validation Study of NOVEOS® System (HYCOR)

Background : The NOVEOS® method is a chemiluminescent immunoassay used to provide quantitative detection of total IgE and allergen-specific IgE antibodies in human serum.

The IgE antibody assay has an essential place in the diagnosis of mediated IgE allergies.

This system could become an alternative to the techniques used today. NOVEOS® uses a quick and convenient method to give results concerning the patient's sensitization profile towards allergens. The volume required for the assays is 4 μl (against more than 100 μl for current techniques), which is particularly important in pediatric and geriatric populations where it may be more difficult to take larger samples.

NOVEOS® also brings true autonomy. In fact, the incorporated reagents provide sufficient capacity for 8 hours of continuous testing.

Objective: Validate the NOVEOS® system as an allergy diagnostic tool, by estimating the sensitivity and specificity of the NOVEOS® assays compared to the gold standard diagnostic represented by the clinical history and PT positive, for a panel of 20 allergens

Methods: This is a validation study of a new immunoassay method (Système NOVEOS®).

The study includes :

* A preliminary phase to familiarize the team with the use of the NOVEOS® system. It is planned to analyze its technical characteristics: the precision, the sensitivity. Eight allergens will be tested, on a cohort of 136 patients
* A validation study of the technique as a diagnostic tool for allergy (sensitivity and specificity compared to the gold standard represented by clinical history and positive PT) and comparison between the new technique and the ImmunoCap® system. Twenty allergens will be tested prospectively, each on 50 cases and 10 controls. A single patient may be both a case for an allergen and a witness for another. For rare allergies, the blood database of the Allergy Service will be used, and affected patients will be contacted to request their non-opposition.


Eligibility Criteria:
IncInclusion criteria:

* Patient who is at least 6 years old
* The patient must be an affiliate or beneficiary of a health insurance plan

Exclusion criteria:

* Patient refusing to take part in the study
* Patient participated in another study that may influence test results
* The patient is in an exclusion period determined by a previous study
* The patient is under the protection of justice, under guardianship or under curatorship
* Patient under antihistaminic H1 treatment preventing the achievement of Prick-tests
* The patient is pregnant
* The patient is breastfeeding
* The patient has a history of tumor, autoimmune, or immune deficiency pathology
* The patient suffers from a hematological pathology (coagulation disorders, anemia) that could interfere with the blood test
Adipose Inflammation and Diabetes (FAB)

The study investigates whether the addition of resolution molecules can inhibit inflammation and insulin resistance in human tissue taken from obese individuals, and whether the results of these studies correlate with patient-specific resolution phenotypes.


Eligibility Criteria:
Inclusion Criteria:

* BMI 30-40 kg/m2
* Ptos (i.e. excess skin) \> 3 cm
* Patient underwent gastric bypass surgery \>2 years ago
* Patient has had a stable weight ≥6 months at the time of operation
* Patient does not smoke (min 6 weeks prior to surgery)

Exclusion Criteria:

* Patients who do not understand spoken and written Swedish
* American Society of Anesthesiologists (ASA) classification ≥ 3
* Neurological, orthopedic or rheumatologic injury or illness affecting physical ability
* Preoperatively known hernia requiring surgical operation
* Severe mental illness
A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI

Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients.

This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the typical skin eruption caused by EGFRI.


Eligibility Criteria:
Inclusion Criteria:

* metastatic colon cancer patients
* male or female
* age\> 18
* treated EGFRI

Exclusion Criteria:

* prior treatment with EGFRI
Multiwave Locked System Laser for Patients With Bell's Palsy.

Background: Idiopathic Bell's palsy (IBP) is a unilateral facial paralysis of sudden onset and unknown etiology. Patient with IBP has an impaired facial expressions and psychological affection, which interfere with social communication. Multiwave locked system (MLS) laser therapy is a class IV laser with synchronizes emission of an 808 nm continuous laser and a 905 nm pulsed laser. It is proposed that MLS facilitates greater penetration and therapeutic effects than low-level laser therapy (LLLT).

Aims: The aim of present study is to investigate the effect of MLS laser in the treatment of patients with unilateral IBP.

Participant: A total number of 60 patients with IBP will be recruited from Makkah hospitals. Treatment will begin in the subacute phase as they referred from neuro-doctors. All the recruited patients will be randomly assigned into three groups of 20 patients each.

Intervention: All patients will be treated with facial massage and exercises. In addition, group one will receive MLS laser with 10 J/cm2 in scanning mode while the group two will receive 10J/point for eight points.

Measured variables: Facial disability scale (FDI) and House-Brackmann scale HBS will used to assess the grade of facial nerve recovery. The scores of both questionnaires will be collected at the baseline, after three and six weeks after treatment.

Statistical Analysis: The Friedman and Wilcoxon signed ranks tests will be used to compare the FDI and HBS scores within each group

Multi-wave locked system (MLS) laser therapy had been presented in the arena of rehabilitation and attained interests of numerous researchers due to its unique features. MLS laser is a Class IV, high-power laser, which is characterized by a combination of two waveforms of continuous emissions of an 808 nm wavelength and a pulsed 905 nm emitted in synchrony. MLS used recently in research and revealed significant reduction of musculoskeletal pain and disability. Researchers recommend its use in case of muscle lesions and/or diseases. No proved way was shown to use laser in the treatment of facial palsy in either scanning the affected side or applying laser to specific motor points.

It was proposed that the combination of the dual laser waveforms offers better penetrability and outcomes on than ordinary lasers and help in recovery of facial muscle.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has unilateral IBP either on the right or left side.
* Treatment will begin in the sub-acute stage of illness 3-5 days after the acute onset subsided.
* patients will accept to attend to the physical therapy department to receive their corresponding treatment twice a week for successive six weeks.

Exclusion Criteria:

* Patients who have central nervous system pathology
* sensory loss over the face, or recurrence of BP.
* Patients with upper motor facial nerve palsy will be also excluded.
* Any infant or child (≤18 years) with BP will be also excluded.
* Chronic facial palsy patients
* Patients BP having after a tumor, stroke, and Lyme disease will be excluded.
Cardiac Output and Duplex Sonography in Carotid Endarterectomy

The aim of this study is to investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a randomized, controlled, single center study at the Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine.

The investigators will investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a randomized, controlled, single center study at the Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine.

For this purpose patients with the need of a carotid endarterectomy (CEA) will be included and randomized either to the regional anesthesia (RA) or the general anesthesia (GA) group until a patient number of 45 in each group is achieved.

The cardiac output and cerebral blood-flow via trans-cranial Doppler (TCD) will be measured at 6 time points:

* T0 Baseline (after insertion of an arterial line)
* T1 After induction of anesthesia, but before surgical start
* T2 Two minutes after clamping the carotid artery
* T3 Two minutes after shunt insertation of the carotid artery
* T4 After reperfusion
* T5 After completion of the skin suture

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years
2. Elective carotid endarterectomy
3. Signed informed consent

Exclusion Criteria:

1. Age under 18 years
2. Missing signed informed consent
Effects of Recoverben® on Recovery After Exhaustive Exercise

The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.

The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.

Targeted parameter will be determined at the beginning of the study and after supplementation, each. Parameter include maximal strength (MVC), muscle soreness (VAS), pain sensitivity (Algometry) and biomarkers (CK, IL-6, glutathione peroxidase).

Eligibility Criteria:
Inclusion Criteria:

* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
* Health volunteers: Subject is in good physical and mental health as established by medical his-tory, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology
* Men and women
* Age ≥ 22 and ≤ 50 years
* BMI: 19-30 kg/m2
* Physically active 1-3 times per week
* Nonsmoker
* Able and willing to follow the study protocol procedures

Exclusion Criteria:

* Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements (e.g. polyphenols, anti-inflammatory or anti-oxidative drugs or supplements, antihyper-tensive drugs) potentially interfering with this study at screening.
* For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
* Diabetes or serious cardiovascular diseases
* Change of dietary habits within the 2 weeks prior to screening (for instance start of a diet high in vegetables and fruits (≥ 5 portions per day))
* Diet high in vegetables and fruits ≥ 5 portions per day
* Participants anticipating a change in their lifestyle or physical activity levels during the study.
* Subjects not willing to abstain from intake of analgesic medication (e.g. Aspirin) 24 hours prior to visit 2 until visit 5.
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
* Known hypersensitivity to the study preparation or to single ingredients
* Pregnant subject or subject planning to become pregnant during the study; breast-
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Blood donation within 4 weeks prior to visit 1 or during the study.
* Subject involved in any clinical or food study within the preceding month
A Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria

A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin, angiotensin, aldosteron.


Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes
* age 18-80 years
* microalbuminuria

Exclusion Criteria:

* blood pressure\> 160/100 mmHg
* persistent macroalbuminuria
* pregnancy or in risc of this
* P-Potassium\>5.7 mmol/l
* Eplerone treatment