cyrilzakka/clinical-trials huggingface dataset:
Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease: a Pilot Study

There is likely a role for using anti-fibrotic medications in patients with myositis-associated interstitial lung disease (MA-ILD) to slow down disease progression, especially in patients who have fibrotic and progressive disease. These patients however are currently being excluded from clinical trials of anti-fibrotic agents in progressive ILD because of the concomitant use of immunosuppression. The benefit of anti-fibrotic agents is being assessed in other rheumatic diseases and should be assessed in MA-ILD as well. They are a unique group of patients with a heterogeneous disease, and are much more frequently on concomitant immune-modulating therapy. As such, they should be studied on their own in separate clinical trials, and the use of nintedanib should be studied as an addition to standard of care immunosuppression.

The objective of this study is to assess safety and tolerability of nintedanib in patients with MA-ILD.


Eligibility Criteria:
Inclusion Criteria:

* 1. 18 years and older 2. Diagnosis of autoimmune myopathy (dermatomyositis, polymyositis, overlap myositis or anti-synthetase syndrome) as diagnosed by a rheumatologist.

  3. Interstitial lung disease confirmed by high resolution CT scan (Extent of disease 10% or more on CT done within 12 months of enrolment) with evidence of fibrosis, defined as reticular abnormality with traction bronchiectasis with or without honeycombing.

  4. Evidence of progressive disease within 24 months of screening visit:
  1. Clinically significant decline in Forced Vital Capacity (FVC) % pred based on a relative decline of \>=10%
  2. Marginal decline in FVC % pred based on a relative decline of .\>=5-\<10% combined with worsening of respiratory symptoms
  3. Marginal decline in FVC % pred based on a relative decline of \>=5-\<10% combined with increasing extent of fibrotic changes on chest imaging
  4. Worsening of respiratory symptoms such as cough or shortness of breath as well as increasing extent of fibrotic changes on chest imaging as per radiologist or pulmonologist who read the scan 5. Current and ongoing treatment with immunosuppressive medications, on a stable medication regimen and dosage for at least 6 weeks (considered standard of care medical therapy) Concomitant medications allowed are:

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  1. mycophenolate,
  2. azathioprine,
  3. tacrolimus,
  4. cyclosporine,
  5. rituximab (injection within the last year),
  6. prednisone low dose =\<20 mg daily,
  7. Intravenous immunoglobulins

Exclusion Criteria:

1. Contraindication to treatment with nintedanib (based on Canadian labeling)
2. The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
3. The male patient plans to father a child during the course of the study
4. Hypersensitivity to nintedanib, peanut or soy
5. Elevated liver enzymes greater than 1.5 times the upper limit of normal
6. Creatinine clearance \<30 mL/min
7. Patient with risks factors of aneurysm or artery dissection, such as known history of aneurysm or uncontrolled hypertension
Indirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast

To determine the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H\&N cancers


Eligibility Criteria:
Inclusion Criteria:Patients with newly diagnosed squamous cell carcinomas of the H\&N with primary tumor sites that are accessible to direct contrast injections
The Effect of Remifentanil-dexmedetomidine Compared With Remifentanil-midazolam on Patient's Satisfaction

Percutaneous trans-arterial angioplasty(PTA) is one of the peripheral arterial occlusive disease(PAOD) treatment. During and after PTA, ischemia-reperfusion pain is induced so proper analgesia is important. ischemia-reperfusion injury is due to reactive oxygen species. Dexmedetomidine has analgesic, sedative and anti oxidant effect. So the investigators research the patient's satisfaction that are given the dexmedetomidine during PTA procedure.


Eligibility Criteria:
Inclusion Criteria:

* patients who are scheduled to undergo percutaneous trans-arterial angioplasty
* American Society of Anesthesiologists (ASA) class I, II, III

Exclusion Criteria: Subjects are ineligible if they have the below condition

* psychiatric medication
* myocardial infarction within 1 year
* cardiac surgery within 1 year
* heart failure
* fever (\>38 degree)
* uncontrolled hypertension
* cognitive dysfunction
* disabling mental change disorder
* being unable to communicate or speak Korean
Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment.
* Female subjects of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria:

* Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine.
* Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.
Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis

Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence of this treatment decreases the control of the disease and the effectiveness of the associated treatments.

The aim would be to study the observance of patients with RA and to be able to propose adequate solutions favoring patient compliance and thus the stability of the pathology.

For this purpose, 3 methods of communication have been put in place to encourage adherence: usual care by the rheumatologist, sms sending or pharmaceutical maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients attending Day Hospital or consultation of rheumatology with rheumatoid polyarteritis and under treatment with MTX alone or in combination with another therapeutic, fixed dosage for at least 3 months.
* Consenting Patient
* Literate French-speaking patient,
* Patient with a mobile phone
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patient not managing his own treatment
Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.


Eligibility Criteria:
Inclusion Criteria:

* Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis \[RRMS\] or secondary progressive multiple sclerosis \[SPMS\] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018)
* Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization
* Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score \<= 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years
* Participants are neurologically stable for \>= 30 days prior to both screening and baseline (Day 1)
* Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
* Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
* Participants have given written informed consent prior to any study-related procedure
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b).

Participants with secondary progressive MS without evidence of relapse

* Disease duration more than (\>) 10 years in participants with an EDSS =\< 2.0 at screening and Baseline (Day 1)
* Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease
* Other protocol defined exclusion criteria could apply.
Combined Fluorocholine Positron Emission Tomography and Magnetic Resonance Imaging (FCH-PET/MRI) in Curative Treatment of a Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth most common cancer in terms of incidence and the second in terms of mortality. At an early stage, which is based on a low number and size of liver nodules and the absence of extra-hepatic locations (Milan criteria), a curative treatment can be performed, i.e. liver transplantation, surgical resection, or thermo-ablation. These treatments can lead to severe complications, so patients benefiting from them must be carefully selected. The correct identification of all HCC lesions at the time of the therapeutic decision is crucial. MRI is the reference examination for diagnosis but its field of exploration is limited to the upper abdominal area and its sensitivity decreases for nodules of less than two centimetres. Such lesions could actually be HCC that will cause early post-operative progression.

Positron Emission Tomography (PET; functional imaging) with fluorodeoxyglucose can provide prognostic information but impacts initial staging in less than 5% of cases. However, PET with fluorocholine (FCH), available in France since 2010, could detect intra- and extra-hepatic HCC lesions not identified by conventional imaging, potentially impacting patient management (e.g. 52% of patients in a small case study).

FCH-PET/MRI could therefore be the ideal examination for the initial staging of HCC, combining in a single multimodality investigation the reference morphological imaging technique and an efficient functional one. The hypothesis of this study is that FCH-PET/MRI is able to detect, in patients eligible for curative treatment, additional preoperative intra- and extra-hepatic early or metastatic HCC unseen or equivocal with conventional imaging (CT and MRI) and responsible for recurrence or disease progression at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Primary HCC proven by histological or imaging examinations (LIRAD 4 or 5)
* Eligible for curative treatment (Barcelona criteria) i.e. hepatic transplantation according to Milan criteria, surgical resection, or thermo-ablation, according to a multidisciplinary decision care committee
* Affiliated to, or a beneficiary of, a social security system
* Written informed consent.

Exclusion Criteria:

* Patient refusing curative treatment
* Patient with HCC not eligible for curative treatment according to conventional imaging (CT, MRI)
* Patient with performance status \>1
* Contraindication to MRI
* Pregnant or lactating woman
* Adult ward of court (under guardianship or trusteeship)
Eye-tracking Technology for Severe Communication Disability

The aim of this project is to develop an Augmentative and Alternative Communication intervention through the use of Eye tracker system.

The term "complex communication needs" includes all patients who present severe disturbances in speech and language production and/or in comprehension, in relation to oral or written communication modalities. The main purpose of Augmentative and Alternative Communication (AAC) is to promote the best possible communication for people with complex communication needs, through the use of techniques, methods and tools aimed not at replacing pre-existing communication methods but at increasing skills of natural communication through the enhancement of present skills. The Eye tracker system, thanks to allows the recording and analysis of eye movements, could be used successfully to support communication in patients with severe communication disability.

The goal of this study is to develop an efficacy Augmentative and Alternative Communication intervention using eye-tracking technology for patients with severe communication disability.

The secondary objective was to examine the psychosocial impact of technology for AAC on parents' perspectives and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* aged between 3 and 17 years affected by neuropsychiatric pathology presenting complex communication needs
* Control of eye motility and visual fixation
* ability to maintain position in front of the monitor
* availability of at least one member of the family nucleus to participate in the therapeutic process
* cognitive skills appropriate to the task such as being able to recognize images and being able to memorize procedures necessary to use the various basic functions

Exclusion Criteria:

* age not between 3 and 17 years
* difficulty in controlling ocular motility and visual fixation
* the unavailability of at least one member of the family nucleus to participate in the therapeutic process
* impaired cognitive skills on the task such as being able to recognize pictures and being able to memorize procedures necessary to use various basic functions
Malignancy Meta Analysis for BRL49653

Observational analyses of data from population registeries have suggested that metformin may be associated with a decreased prevalence of malignancy. The ADOPT and RECORD studies both contain groups of subjects randomly allocated to metformin and rosiglitazone. This meta-analysis combines malignancy serious adverse events from ADOPT and RECORD in order to compare their incidence on metformin with that on rosiglitazone.

The objective of this meta-analysis is to compare the incidence of malignancy (excluding non-melanomatous skin cancers) reported as serious adverse events in the ADOPT and RECORD studies between subjects randomly allocated to treatment with metformin with those allocated to rosiglitazone.

Eligibility Criteria:
Subjects from ADOPT that are included in this meta-analysis (those in the metformin or rosiglitazone groups) had the dose of their study medication increased to a maximum of 2g (metformin) or 8mg (rosiglitazone) if their fasting plasma glucose was greater than 140mg/dl.

Subjects from RECORD that are included in this meta-analsyis entered the RECORD study taking one of three sulfonylureas (glibenclamide, gliclazide or glimepiride). They were randomly allocated to metformin or rosiglitazone in a 1:1 ration to use as add-on treatment to the background of sulfonylurea. These subjects had the dose of their study medication increased to a maximum of 2.55g (metformin) or 8mg (rosiglitazone) if their HbA1c was greater than 7.0%.
Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension

Pulmonary hypertension (PH) is a life-threatening cardiovascular disease characterized by pathological elevation of mean pulmonary arterial pressure (mPAP) \>/= 25 mmHg at rest. mPAP \< 20 mmHg is defined as normal, values in the range between 21-24 mmHg are described as "borderline PH" diagnosed by right heart catheterization. Based on the etiology, PH is assigned to 5 groups (WHO, Data Point, 2008), whereas classification of disease is an important prognostic and therapy-deciding criterion.

Cardiac magnetic resonance tomography (CMR) provides a reliable technique to estimate elevated mean pulmonary arterial pressure from period of existence of a vortical motion of blood flow in the main pulmonary artery. Vortex can be visualized in 3-dimensional vector field, particle trace and streamline representations and can be analysed with respect to vortex related measures (geometry of center, vortex formation, vorticity, propagation dynamics ...). Furthermore T1-mapping and non-contrast enhanced lung perfusion/ventilation scans represent promising techniques for PH characterization.

Aim of this explorative study is to 1. analyse PH-associated blood flow characteristics in the heart and the surrounding great vessels with respect to the 5 groups of PH, and 2. investigate the hemodynamic state of "borderline PH" compared to normal mPAP and manifest PH by non-contrast CMR.


Eligibility Criteria:
Inclusion Criteria:

* patients with suspected or known PH scheduled for routine right-heart catheterization,
* ability to give informed consent.

Exclusion Criteria:

* General MR exclusion criteria eg. patients with metal devices or other magnetic material in or on the subjects body which will be hazardous for MR investigation (e.g. heart pace-maker, brain aneurysm clip, nerve stimulators, electrodes, penile implants, coloured contact lenses, patch to deliver medications through the skin, any metal implants as rods, joints, plates, pins, screws, nails or clips, embolization coil, or any metal fragments or shrapnel in the body),
* patients with tendency toward claustrophobia,
* hemodynamically unstable patients,
* pregnancy.
Comparison of Efficacy of Nebulizing Budesonide and Intravenous Dexamethasone Before Extubation on Prevention of Post-extubation Complications in Intensive Care Unit Patients

The present study was aimed at investigating the efficacy of nebulizing Budesonide sin comparison with intravenous Dexamethasone before extubation in prevention of post-extubation complications amongst patients admitted in intensive care unit.

In this double-blind randomized clinical trial study, 90 patients (age between 18 to 65) who are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in the study after obtaining a written informed consent from their parents or guardians.

The investigators divide our patients randomly into two equal groups.

-In the budesonide group patients underwent a therapy with nebulizing Budesonide at a dose of 1 mg diluted in 4 cc of sterile water for 20 minutes, one hour preceding extubation. After extubation patients received nebulizing budesonide via oxygen mask at the same dose every 12 hours for 48 h.i In dexamethasone group intravenous dexamethasone was administered to patient at a dose of 0.15 mg/kg before extubation. After extubation, the administration of intravenous Dexamethasone continued at the same dose every 12 h. for 48 h.

Another anesthesiologist who is unaware about kind of medication, will evaluate the patients for severity of stridor. We will record the vital sings and grade of stridor every 6 hour. Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen saturation (SPO2) were recorded for each patient immediately before aerosol administration (time 0) and at 30 and 60 min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the presence of stridor (heard with the aid of stethoscope) was recorded within 48 hr of extubation


Eligibility Criteria:
Inclusion Criteria:

1. Patients' age 18-65 years old
2. Intubated for more than 48 hours after surgery
3. Met the weaning criteria defined as respiratory rate \< 30 breaths / min, negative tidal volume \> 5 ml/kg ideal body weight, and shallow index (respiratory rate/tidal volume) \< 105 breaths / min/L

Exclusion Criteria:

1. Any history of corticosteroid therapy in previous week
2. Nasal or throat disease / surgery
3. Pulmonary airway disease
4. Gastrointestinal bleeding
Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)

Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection. These conditions initiate an inflammatory response characterized by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the development of significant acute and chronic lung injury.

The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10 is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and is the most abundant protein in the mucosal fluids in normal healthy lungs.

The purpose of this study was to evaluate the pharmacokinetics, safety, tolerability and anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated premature infants receiving positive pressure ventilation for treatment of respiratory distress syndrome (RDS) to prevent long term respiratory complications referred to as bronchopulmonary dysplasia, and, more recently, as chronic respiratory morbidity (CRM; asthma, cough, wheezing, multiple respiratory infections).

CC10 regulates inflammatory responses and protects the structural integrity of pulmonary tissue while preserving pulmonary mechanical function during various insults (eg. viral infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties suggest that administration of rhCC10 may help to facilitate development of normal airway epithelia and prevent the inflammation that leads to CRM in these infants.


Eligibility Criteria:
Inclusion Criteria:

Newborn infants were considered for the study if the following criteria were met:

* Age \< 24 hours;
* Birthweight between 700 and 1,300 grams;
* Gestational age greater than or equal to 24 weeks;
* Diagnosis of neonatal RDS based on clinical and radiographic criteria;
* Requiring intubation and mechanical ventilation for treatment of RDS;
* Received at least one dose of surfactant 100 mg/kg (Survanta; Ross Laboratories);
* Written informed consent from the infant's parent or legal guardian prior to enrollment of the patient and agrees to all study-related procedures and evaluations, including those required after hospital discharge.

Exclusion Criteria:

• Major congenital abnormalities (chromosomal, genetic, cardiac, pulmonary, or renal);