cyrilzakka/clinical-trials huggingface dataset:
Are Mast Cells Involved in Autoinflammatory Diseases

Autoinflammatory diseases (AID) are caused by innate immunity dysregulation. AID pathophysiology is only partly understood, especially in the case of unclassified AID. Mast cells (MC) are innate immune cells associated with a spectrum of disease between systemic mastocytosis and mast cell activation syndrome. The implication of MC has been shown in cryopyrin associated periodic syndrome (CAPS).Our aim is to evaluate the involvement of MC in AID by assessing clinical and biological signs of MC activation and studying cutaneous and digestive biopsies.

Autoinflammatory diseases (AID) are caused by innate immunity dysregulation and characterized by recurrent bouts of fever, frequently associated with digestive, articular or cutaneous symptoms, and sometimes ocular, auricular or neurologic inflammation. The most frequent monogenic AID is Familial Mediterranean fever (FMF).

Despite recent genetic progress AID pathophysiology is only partly understood, especially in the case of unclassified AID.

Mast cells (MC) are innate immune cells associated with a spectrum of disease between systemic mastocytosis and mast cell activation syndrome (MCAS). In MCAS, patients have various symptoms including abdominal pain, bloating, pruritus, flush, anxiety, fatigue, among which some are similar to those seen in patients with AID. The implication of MC has been shown in cryopyrin associated periodic syndrome (CAPS).

Our hypothesis is that MC could be involved in AID pathophysiology,

In order to test this hypothesis, we plan to study :

* clinical MC activation symptoms via a standardized clinical score
* biological MC mediators : by measuring total serum tryptase and histamine in total blood, plasma and urine
* MC infiltration on gastro-intestinal (GI) tract and cutaneous biopsies We will compare clinical MC activation score in AID patients to patients with mastocytosis, with other inflammatory diseases, and with healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old with Auto-inflammatory diseases already followed up at the CeRéMAIA (french national reference center for autoinflamamtory diseases and AA amyloidosis) of Tenon hospital and included in the JIRcohorte
* Healthy adult controls, age- and sex-matched with MAI patients, and controls with mastocytosis, an immuno-inflammatory disease.
* Subject affiliated to or entitled to a social security scheme
* Collection of the patient's or healthy control's non-opposition

Exclusion Criteria:

* Subjects unable to answer questions or express themselves
* Subjects who do not speak French
* Subject deprived of liberty or under legal protection.
Cemented K-wire Fixation vs Open Transfixion Pinning

To introduce a novel external-fixation technique using the combination of K-wires and cement, and the objective of this report is also to compare the technique with conventional open transfixion pinning.

Shaft fractures of the middle phalanx are common injuries that are often difficult to treat. Currently, fracture fixation is usually achieved by using K-wire, but pin configurations are controversial.The objective of this report is to introduce treatment of shaft fractures of middle phalanx with a novel external-fixation technique using combined K-wires and cement. For comparison, we also included another group of patients who were treated using open transfixion pinning.A total of 98 patients (98 fingers) with shaft fractures of middle phalanx were randomly allocated to group A (n=51) and B (n=47). Fingers in group A were treated with cemented K-wire fixation, and fingers in group B were treated using conventional open transfixion pinning. Time of bone healing, range of motion of the fingers, and joint motion were assessed. A p\<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* patient aged between 18 and 65 years;
* acute fractures within 15 days;
* closed fractures or fractures with small open wound less than 1.5 cm;
* involvement of single middle phalanges of index to little fingers;
* shaft fractures; at least 5 mm in length of the most distal and proximal fragments so that K-wires can be secured;
* transversal, short oblique or spiral fractures;
* comminuted fractures of middle third phalanx;
* normal opposite hand for comparison.

Exclusion Criteria:

* patients younger than 18 years are excluded because of skeletal immaturity;
* patients older than 65 years are excluded because of possible osteoporosis;
* multiple finger involvement; severe open injury or crush injuries;
* combined tendon or neurovascular injuries; involvement of articular surface;
* old fractures exceeding 15 days because close reduction most likely became difficult;
* combined tendon, nerve, or artery injuries or diseases;
* diabetes, gout, ganglion;
* osseous tumors, and other disease affecting bony structures and joint motion;
* patients who declined to participate.
A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine

The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of migraine or chronic migraine.
* History of migraine headaches at least 1 year prior to screening, with onset prior to age 50.
* History of at least 4 migraine headache days and at, with at least 1 headache-free day per month on average within the past 3 months.
* Have documentation of 2 to 4 migraine preventive medication category failures due to inadequate efficacy or tolerability, in the past 10 years.

Exclusion Criteria:

* Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
* Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.
* History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine).
* Pregnant or nursing.
The Effects of Miminal Stimulation Protocol on Preimplantation Genetic Screening

PGS has been the most effective method for embryo selection in IVF cycles. Euploidy rates decrease significantly with advancing maternal age (AMA). The dosage of gonadotropins also may be increased to recruit an adequate number of follicles in AMA women, minimal Stimulation Protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) for controlled ovarian hyperstimulation is defined for poor ovarian response women. The aim of this study is to show minimal stimulation protocol affect euploidy and pregnancy rates in preimplatation genetic screening (PGS) cycles with single embryo transfer.


Eligibility Criteria:
Inclusion Criteria: Advanced maternal aged -

Exclusion Criteria: Severe male factor, endometriosis, and absolute tubal factor were excluded in this study.

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Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)

The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older with chronic (\> 3months, \< 18 months) macular edema secondary to branch retinal vein occlusion
* Patients who at baseline have a BSCVA in the study eye between 20/320 and equivalent to 20/40, using an ETDRS chart measured at 4 meters
* Patients who at baseline have a chronic macular edema (\> 3 months) in the study eye with the following characteristics as determined by fluorescein angiography:
* Evidence that the macular edema extends under the geometric center of the foveal avascular zone.
* Evidence that the edema is only secondary to BRVO (no other relevant ocular diseases, e.g. uveitis).
* Patients who at baseline have a chronic macular edema (\> 3 months) in the study eye with the following characteristics as determined by optical coherence tomography (OCT 3):
* Evidence that central macular thickness is \> 225 μm.
* Ability of subject to understand character and individual consequences of clinical trial.
* Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
* For women with childbearing potential, adequate contraception (negative pregnancy test result, serum or urine at trial entry, after treatment and at end of study).
* Only one eye of a patient may be included to this trial.

Exclusion Criteria:

* Patients who at baseline
* Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, neovascular age-related macular degeneration, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, and others)
* Have a relevant systemic disease which may be associated with increased systemic VEGF levels (namely all malignancies)
* Had previous treatment for macular edema (laser, triamcinolone, vitrectomy)
* Pregnancy and lactation.
* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
* Participation in other clinical trials within the last 3 months.
* Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
* Arterial hypertension refractory to medical treatment
Acupuncture or MBSR for Patients With Fatigue and MS

The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis.

In multiple sclerosis, fatigue is the most common clinical symptom, reported by up to 97% of patients. No successful evidence-based therapy exists so far. The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis. We want to include 141 patients with multiple sclerosis and fatigue. Participants will be randomised into three groups to compare 1) usual care, 2) usual care plus standardised acupuncture, and 3) usual care plus mindfulness-based stress reduction. Treatment duration will be 12 weeks. The primary outcome is the Fatigue Severity Scale (FSS) after 12 weeks, follow-up measurement will be performed after 26 weeks. Secondary outcomes include other fatigue specific parameters, other MS specific parameters, cost, and physiological, immunological and functional magnetic resonance imaging parameters.

Eligibility Criteria:
Inclusion Criteria:

* female or male
* 18 to 65 years of age
* able to give oral and signed written informed consent
* clinical diagnosis of multiple sclerosis
* fatigue in "multiple sclerosis" for at least 3 months
* other stable pre-study treatment with respect to target symptom fatigue for at least 3 months before inclusion
* stable immunomodulatory or immunosuppressive therapy or stable no such a therapy for at least the 3 months before inclusion
* fatigue score of ≥4 on the Fatigue Severity Scale at inclusion
* patient's mental and physical ability to participate in the trial
* willingness to be randomised, to attend visits, to complete questionnaires, and willingness to participate and fMRI measurements

Exclusion Criteria:

* fatigue because of a malignant disease
* acute relapse or cortisone therapy therapy in the last 30 days before inclusion
* EDSS (Extended disability status scale) \> 6
* fatigue specific acupuncture in the last 12 months
* during the last 12 months performing of MBSR exercises learnt in the past
* change of immunomodulatory or immunosuppressive therapy during the 3 months before inclusion
* other new therapies are planned which could have a positive effect on fatigue (e.g. exercise, acupuncture, relaxation therapy)
* for female patients: pregnancy or anticipated pregnancy during the intervention period
* severe acute and or chronic disease which does not allow participation in the therapy
* other limitations which do not allow participation in the therapy
* alcohol or substance abuse
* parallel participation in another clinical trial
* BDI \> 29
* contra indications for fMRI session (e.g. metal clips)
Effect of Rabies Immunoglobulin on Immunogenicity of Post-exposure Rabies Vaccination in Obese Patients

A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI \> 30 kg/m2) and normal weight/underweight (BMI \< 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.

A single center, prospective cohort, open-label study of rabies post exposure program with equine rabies immunoglobulin (ERIG) and purified chick-embryo cell (PCEC) rabies vaccine in WHO category III exposed patients at Siriraj Hospital, Thailand aims to compare serum RVNA responses between obese (BMI \> 30 kg/m2) and normal weight/underweight (BMI \< 25 kg/m2) and to evaluate adverse events occurring after immunization on days 7, 14 and 28.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ages of \>= 18 years and older;
2. Experienced WHO category III rabies exposure excluding presenting wound at eye(s) or eye lid(s);
3. Either a) obese with BMI \>= 30 or b) normal weight and/or underweight with BMI \< 25;
4. Agree to independently consent to participate in all study procedures.

Exclusion Criteria:

1. Positive skin test to ERIG or known hypersensitivity to ERIG or its excipients;
2. Co-enrolment with other studies or participated in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug;
3. Female patients who are currently pregnant or breast feeding.
4. Presenting with wound at eye(s) or eye lid(s);
5. Receiving rabies vaccination more than 7 days for this exposure;
6. History of complete pre-exposure or post-exposure regimen with at least 3 doses;
7. Known of allergic to egg or poultry meat;
8. History of previous exposure to equine sera
9. Significant illness that might harm or increase the risk to the patients;
10. History of drug abuse or alcoholism.
UV and Bluelight Dosimetry

The objective of this study to assess the efficacy of wearable Ultra Violet (UV) and blue-light sensors in measuring exposure to UV radiation and blue light in a variety of environments and activity settings.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Subjects willing and able to comply with requirements of the protocol
* Subjects speaking English

Exclusion Criteria:

* Age \<18 years old
* Subjects unwilling and unable to comply with requirements of the protocol
* History of skin allergy to medical adhesive tape or rubber bands/elastic
* Lack of proficiency in English
* Skin disorders affecting skin integrity
Pulse-Width Modulation

The overarching aim of this project is to modulate the pulse-width during stimulation of pedicle screws and record the response thresholds associated with each PWM setting. During this initial phase of the investigation, no further data will be collected.

In vivo electrical stimulation of pedicle screws is a well-documented modality for evaluating potential breach of the pedicle wall. However, previous research has focused primarily on the stimulation threshold intensity required to elicit a neurophysiological response. Other stimulation parameters, such as pulse-width, remain uninvestigated. The goal is to obtain data on the pulse-width vs. CMAP relationship.

Eligibility Criteria:
Inclusion Criteria:

* A patient will be eligible for study participation once they have been booked for a surgery involving pedicle screw placement and intraoperative neuromonitoring.

Exclusion Criteria:

* The study excludes neonates, minors, pregnant women, prisoners and cognitively impaired patients.
Nonopioid Analgesia After Labral Surgery

This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen

Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.

Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia

Primary endpoints is reduction in pain as measured by VAS and PROMIS. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.

Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.

Eligibility Criteria:
Eligibility Criteria:

Inclusion Criteria:

* All adult patients over age 18 and scheduled for a primary or revision labral surgery

Exclusion Criteria:

* Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff
Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 18 years)
* PCR (polymerase chain reaction) -confirmed SARS-CoV-2 infections based on nasopharyngeal swab (NPS), oropharyngeal swab (OPS), tracheal aspirate (TA), bronchial aspirate (BA), or bronchoalveolar lavage fluid (BALF) within 14 days prior to ICU admission or within 72 hours following ICU admission due to severe COVID-19 infection
* Radiographic imaging consistent with SARS-CoV-2 infection (e.g. atypical pneumonia, organizing pneumonia, ground glass opacities) or ARDS within 7 days of diagnosis of SARS-CoV-2 infection

Exclusion Criteria:

* Patients with a diagnosis of invasive aspergillosis/detection of Aspergillus spp. by culture from sputum, TA, BA, or BALF or positive GM from serum, TA, or BALF at baseline (=ICU admission)
* History of invasive aspergillosis within the prior six months
* Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection
* Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection
* Death or transfer to general ward within 48 hours of ICU admission
* Antifungal prophylaxis other than posaconazole (e.g. inhaled amphotericin B)
The Effect of Intraoperative Use of Dexmedetomidine During the Daytime Operation vs the Nighttime Operation on Postoperative Sleep Quality and Pain Under General Anesthesia

General anesthesia is a medically induced state of low reactivity consciousness which is similar to natural sleep. Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow wave sleep (SWS), which have signiﬁcant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.Clinical trials have already proved that intraoperative use of dexmedetomidine (DEX) for general anesthesia, a highly selective alpha-2 adrenergic agonist, was able to improve sedative and analgesia effects and promote sleep quality (by decreasing stage N1 sleep, increasing stage N2 sleep and sleep efficiency). However, Wenfei Tan et al reported that with the deeper sedative state provided by DEX in the daytime, the elderly male patients undergoing TURP under spinal anesthesia suffered worse sleep on the night of surgery. Thus, what the effect of intraoperative using DEX at different time periods under general anesthesia on postoperative sleep quality and pain will be needs further study.

patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were enrolled. Patients were randomized to receive operation in the D group (8:00-12:00) and the N group (18:00-22:00). The Portable Sleep Monitor (PSM) was performed on the following 3 nights: the night before surgery (Sleep1), the ﬁrst night after surgery (Sleep 2), and the third night after surgery (Sleep 3). Postoperative pain scores using visual analogue scoring scale, subjective sleep quality using the Athens Insomnia Scale, total dose of general anesthetics and PCA pump press numbers were also recorded.

Eligibility Criteria:
Inclusion Criteria:

age between 30 and 55 years American Society of Anaesthesiologists physical status I or II.

Exclusion Criteria:

cardiovascular disease long term use of analgesia preoperative heart rate (HR) less than 50 beats/min second- or third-degree atrioventricular block sleep disorder sleep apnea syndrome history of abnormal operation or anesthesia recovery psychosis or a patient with a language communication disorder not willing to cooperate with the experimenter.