cyrilzakka/clinical-trials huggingface dataset:
Esophageal Capsule Endoscopy in Children

The portal hypertension (PHT) is the main complication in patients presenting with cirrhosis. It can be the direct cause of bleeding by rupture of the esophageal or gastric varices and can also contribute to the development of ascites, hepatic encephalopathy and pleuropulmonary complications.

In the paediatric population presenting with the PHT, one of every two children develops varices and thus has a significant risk of bleeding. Safe and easy to use, the video capsule endoscopy (VCE) is now routinely used in children for the exploration of the small bowel. But the role of the VCE for examination of the other parts of digestive tract still needs to be evaluated.

For the esophagus, the VCE could allow the diagnosis without the need of general sedation. Recent studies have shown a good sensitivity and tolerance of this technique for the initial diagnosis of esophageal varices (EV) in adult patients presenting with portal hypertension, but it has not yet been validated for this indication.

The investigators hypothesize that the VCE could be used in children with similar results in term of efficacy, as for adults.

This prospective simple blind multicentre study (blind for the lecture of the capsule endoscopy record), will investigate the diagnostic value of the VCE compared to the conventional esophagogastroduodenoscopy (EGD) under general sedation for the detection and the control of esophageal varices in children.

If it is provided that the VCE is as efficient as it is for the adults, it could become a very interesting alternative to the conventional EGD because less expensive and less invasive. Moreover, this technique would be very useful as a means of early detection on the EV and/or their control.


Eligibility Criteria:
Inclusion Criteria:

* patients between 7 and 18 years old
* presenting a portal hypertension and/or cirrhosis
* patients who are referred for a conventional EGD under general sedation
* patients who are not participating in other clinical studies
* written informed consent obtained from the patient and his/her legal guardians.

Exclusion Criteria:

* patients presenting a contra indication for upper endoscopy or for the ingestion of the video capsule, especially those with clinical or radiological suspicion of upper gastrointestinal strictures (esophageal surgery or eosinophile esophagitys)
* patients presenting with dysphagia or gastrointestinal tract strictures (patients with Crohn's disease, small bowel carcinoma, stenosis due to the chronic use of a NSAI medication, acute necrotizing enterocolitis or prior abdominal surgery of the gastrointestinal tract); swallowing disorders with or without impaired consciousness;
* patients under calcium channel blocking agents medication;
* patient presenting with diverticulosis (Marphan's or Ehlers Danlos's syndrome)
* patients with cardiac pacemaker or other implanted electro medical device
* patients scheduled for a magnetic resonance imaging (MRI) examination within 7 days after ingestion of the capsule (and until the capsule is evacuated)
* any other life-threatening conditions.
Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR

The first outbreak of a new H1N1 influenza pandemic originated in the North America in April 2009. As of July 1, 2009, a total of 77,201 cases were accumulated in 103 countries around the world and the mortality rate of was about 0.43%. Alignment and analysis on gene sequences of the new H1N1 influenza virus found that it contains extremely homologous gene composition with that of the swine influenza viruses (swine flu) identified in Europe and North America in last century. Thus the virus strain was later renamed as a novel influenza H1N1. In general, the symptoms caused by the new influenza H1N1 infection was very similar to those resulted from seasonal influenza viral infection. Thus, it is difficult to distinguish the various influenza strains responsible for the infections only by clinical appearance. To compare the accuracy, specificity and sensitivity and speed in identifying the new influenza H1N1 in suspected cases, the investigators extracted RNA from influenza A-positive reactive specimens identified by a Influenza Rapid Test, for a Real-time PCR method to further detect the presence of swine H1 gene. In addition, the titer of H1N1 virus, the color development on the test stripe and clinical symptoms in patients were significantly associated. Finally, Real-time PCR products were subjected to sequence determination to explore potential new influenza pathogenicity, transmissibility and drug usage.


Eligibility Criteria:
Inclusion Criteria:

* Influenza Rapid Test Influenza A(+) B(-)
* Influenza Rapid Test Influenza A(+) B(+)
* Influenza Rapid Test Influenza A(-) B(-) was negative control

Exclusion Criteria:

* Influenza Rapid Test Influenza A(-) B(+)
Succinylcholine vs Rocuronium for Prehospital Emergency Intubation

All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included in order to compare the use of succinylcholine vs Rocuronium for prehospital emergency intubation.

All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included. All intubation will be performed by an emergency physician or a nurse specialized in anesthesia. For patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation.

Comparisons studied will be : Intubation success rate at the first laryngoscopy, glottis exposure assessed by Cormack and Lehane classification, difficult intubation rate assessed by the Intubation Difficult Score (IDS), the conditions of intubation assessed by the Copenhagen score, the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context

Exclusion Criteria:

* Patients in cardiac arrest;
* Patients under-18s;
* Patients under guardianship ;
* Pregnancy known;
* Patients with cons to one of the following three drugs: rocuronium, succinylcholine, sugammadex;
* Patients not affiliated to a social security scheme (beneficiary or legal).
Effect of Cervical Vagal Blockade on Cough Incidence in Non-intubated Uniportal Video-assisted Thoracic Surgery

Currently, there is a trend toward non-intubated anesthesia methods for video-assisted thoracic surgery in our hospital. During the surgery, intrathoracic vagus nerve blockade is suggested for inhibit cough reflex in previous paper. However, right and left side of vagus nerves both deep near the aorta or trachea respectively. To achieving the procedure may induce cough reflex by lobar traction even result vital organ damage. This study aims to apply alternative vagus nerve blockade at neck level via ultrasound guidance and test if the procedure real reduce cough reflex then previous method. We also follow up the patient's vital sign, vocal cord and diaphragm movement, horner syndrome and hoarseness to evaluating if cervical vagal blockade has the potential risk involve other surrounding nerves


Eligibility Criteria:
Inclusion Criteria:

* Adults younger than 80 years old are scheduled for one-port video assisted thoracic surgery

Exclusion Criteria:

* Anticipated difficult airway, Respiratory insufficiency,Vocal cord palsy,diaphragm palsy parkinsonism,previous stroke,tachycardia
Effect of Blueberry Supplementation on Alzheimer's Biomarkers

The purpose of this study is to study the effects of blueberries on neuronal, glial, and pathology blood biomarkers in Mild Cognitive Impairment (MCI) and to estimate sample size for future confirmatory studies. The blood biomarkers to be measured are Neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Aß40, Aß42, p-tau181, and cytokines, using an ultra-sensitive state-of-the-art immunoassay.

After determining subject eligibility and after subjects have abstained from consuming all berry fruits (including red wine) for 2 weeks, subjects will have blood drawn for biomarkers and will then will undergo 12 weeks of blueberry supplementation in the form of 18 grams lyophilized blueberry powder mixed with water and taken twice daily with meals. All subjects will be asked to abstain from berry fruits (including red wine) for the duration of the 12 week trial. Subjects will receive telephone calls at 4 and 8 weeks to check compliance as well as concomitant medications and adverse events and then all subjects will return at 12 weeks for a repeat biomarker blood draw. Plasma NfL, GFAP, Aβ40, Aβ42, p-tau181, and cytokine biomarker assays will be done using the Quanterix SR-X instrument, a new, state-of-the-art digital immunoassay platform employing Simoa technology, which enables the detection and quantification of biomarkers previously difficult or impossible to measure.

Eligibility Criteria:
Inclusion Criteria:

1. 55 to 85 years old inclusive
2. Meets criteria for amnestic Mild Cognitive Impairment defined by education adjusted performance on the Wechsler Memory Scale (WMS) III Logical Memory delayed recall score and clinical evaluation.
3. Medically stable

Exclusion Criteria:

1. Dementia
2. Significant confounding active neurological/psychiatric disease
3. Participation in an experimental investigational drug trial in the past 30 days
4. Unwilling to restrict consumption of anthocyanin-rich foods
5. Inability to complete cognitive testing (e.g. significant visual or hearing impairment)
6. Allergy or intolerance to blueberries
7. Significant gastrointestinal disorders or surgery that influences digestion and absorption
8. Presence of unstable, acutely symptomatic, or life-limiting illness
9. Women of childbearing potential
A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.

This multi-center observational study will prospectively collect data from patients who have an indication for servo ventilation therapy. This registry is intended to characterize the patient populations that may benefit from DreamStation BiPAP autoSV therapy (PR DS-autoSV, Philips Respironics, Monroeville, PA) in real life settings. In addition, this registry will assess adherence to the PR DS-autoSV therapy, the therapeutic benefits, collect morbidity and mortality data of servo ventilation in patients with central sleep apnea (CSA) and complex sleep-disordered breathing (SDB).


Eligibility Criteria:
Inclusion Criteria:

* Indication and prescription of PR DS-autoSV
* Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation

Exclusion Criteria:

* Patients with HFrEF - heart failure and low ejection fraction (EF ≤ 45%) and predominant CSA (\> 50 % of events)
* Patients not able to receive positive airway pressure support through a mask due to surgical procedure or anatomical condition
* Chronic conditions with life expectancy \< 1 year
* Significant chronic obstructive pulmonary disease (COPD) with an FEV1/VC \< 70% (GOLD III)
* Respiratory insufficiency requiring long-term oxygen therapy
* Daytime hypercapnia at rest (pCO2 \> 45 mmHg)
* Cardiac surgery, PCI, myocardial infarction, unstable angina, within 12 weeks prior to enrolment
* Cardiac resynchronization or pacemaker implantation within the last 6 months
* Untreated or therapy refractory Restless legs-Syndrome (RLS)
The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.

butyrate enemas will be administered for 12 weeks to children ages 7 to 21 with mild to moderate ulcerative colitis to determine if butyrate therapy can help improve the clinical disease in those children. standard management of the disease will be performed during these 12 weeks including routine laboratory studies and endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* 7-21 years, mild to moderate ulcerative colitis

Exclusion Criteria:

* UC therapy within 4 weeks of study medication initiation
* infectious colitis, -pregnancy
Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy

This study is meant to assess the effectiveness of idebenone on visual function measures in patients with Leber's Hereditary Optic Neuropathy over a 6 months period.

The study involves 6 clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 14 years and \< 65 years
* Impaired visual acuity in at least one eye due to LHON
* Onset of visual loss due to LHON lies five years or less prior to Baseline
* Confirmation of either G11778A, T14484C or G3460A LHON mtDNA mutations at \>60% in blood
* No explanation for the visual failure besides LHON
* Body weight ≥ 45 kg
* Negative urine pregnancy test at Screening and at Baseline (women of childbearing potential).

Exclusion Criteria:

* Treatment with Coenzyme Q10 or idebenone within 1 month prior to Baseline
* Pregnancy and/or breast-feeding
* Weekly alcohol intake 35 units (men) or 24 units (women)
* Current drug abuse
* Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine
* Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
* Other factor that, in the investigator's opinion, excludes the patient from entering the study
Creative Arts Program to Reduce Burnout in Healthcare Professionals

This study plans to learn if creative arts programs that include visual, musical, written, or physical expression can reduce symptoms of burnout syndrome, Post Traumatic Stress Disorder (PTSD), depression, and anxiety in critical care healthcare professionals. This study also explores if creative arts can enhance the connection to the purpose of work, the development of adequate coping skills, while providing time to connect with peers.


Eligibility Criteria:
Inclusion Criteria:

* Employed as a healthcare provider, practicing primarily in a hospital setting for at least 20 hours per week.
* Positive symptoms of burnout measured via the Maslach Burnout Inventory (MBI):

  * emotional exhaustion score of \>17, or
  * depersonalization score of \>7, or
  * personal accomplishment score of \< 31.

Exclusion Criteria:

• Unwillingness to participate in any of the four creative arts interventions.
Sleep Apnea in Sickle Cell Disease

Despite the fact that obstructive sleep apnoea (OSA) is highly prevalent in the sickle cell population, studies focusing on the associations of the two diseases and their common pathophysiological mechanisms are scarce. OSA is one of the most common conditions responsible for hemoglobin desaturation. The nocturnal hemoglobin desaturation occurring in some sickle cell disease (SCD) patients with OSA could trigger hemoglobin S polymerization and red blood cell (RBC) sickling, leading to further blood rheological alterations, hence increasing the risks for VOC. Moreover, OSA has been demonstrated to increase oxidative stress and inflammation in non Sickle Cell Disease (SCD) patients, which, in SCD patients, could increase the risk for complications. Finally, OSA is accompanied by impaired vascular function and autonomic nervous system dysfunction in the general population. Indeed, the presence of OSA in SCD could increase the clinical severity of patients and the frequency of VOC.


Eligibility Criteria:
Inclusion Criteria:

* Homozygous HbS (Hemoglobin S) (SS) patients,
* aged between 15 and 3 months and 50 years old,
* in steady state (i.e. without vaso-occlusive crisis or recent blood transfusion),
* followed by the sickle cell center of the Hospices Civils de Lyon,
* and showing symptoms of OSA.

Exclusion Criteria:

* Patients receiving treatment of OSA,
* recent blood transfusion (less than 2 months),
* patients not at steady state (VOC or acute chest syndrome less than 2 months),
* pregnancy.
Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)

The FLOW-PROMOTE Study is an investigator-initiated, Danish multicenter study of patients with stable chest pain investigating whether lipid lowering is associated with recovery of impaired coronary flow as assessed by CT derived fractional flow reserve (FFRCT).

Multicenter study (4 centers in Denmark), including 120 patients with stable chest pain and hemodynamically significant coronary artery disease as assessed by FFRCT. By using two lipid lowering treatment strategies ("usual" vs "intensive" care) over 18 months, the effect on coronary plaque regression and flow recovery are assessed from repeated CT angiograms with plaque and FFRCT analyses at 9 and 18 months.

Eligibility Criteria:
Inclusion Criteria:

1. Symptoms suggestive of stable coronary artery disease (CAD)
2. No known CAD
3. At least one coronary stenosis with \>49% lumen reduction determined by CT angiography
4. Sinus rhythm
5. At least one lesion with FFRCT \<0.81 (see below)
6. Life expectancy \>3 years
7. Fertile women must use safe contraception throughout the study period
8. Signed informed consent

5. LDL cholesterol \>2.0 mM (patients already on lipid lowering medical therapy \< 3 months can be included if meeting all of the above mentioned criteria)

Exclusion Criteria:

1. Unstable angina
2. Known CAD
3. Body mass index \>40
4. Allergy to iodinated contrast media
5. Known statin intolerance
6. Poor coronary CT angiography image quality inadequate for FFRCT calculation (determined by core-laboratory)
7. Significant left main coronary artery (stenosis \>49%) or three-vessel CAD determined by coronary CT angiography leading to direct referral to ICA
8. FFRCT \<0.81 over the left main coronary artery or the proximal left anterior descendens artery (LAD) segment, or \<0.76 over the mid-LAD, proximal circumflex, right coronary artery or intermediate coronary segments
9. Pregnancy (women with age \>45 will be screened for pregnancy)
10. Moderate to severe liver failure
11. Estimated glomerular filtration rate (eGFR) \< 60 ml/min
12. Participation in another trial
13. Does noes not wish to participate
Controlling Myopia Progression With Soft Contact Lenses

This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be between 8 and 12 years of age and of Asia origin.
2. The subject's best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes)
3. Astigmatism must be less than or equal to 1.00D
4. Less than 1.00D difference in spherical equivalent between the two eyes
5. The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes
6. The subject must have at least 8D of accommodation.
7. The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form
8. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol

Exclusion Criteria:

1. Ocular or systemic allergies or diseases that may interfere with contact lens wear
2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamines), which may interfere with contact lens wear.
3. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
4. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any infectious disease (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
8. Diabetes.
9. Anismetropia.
10. Astigmatism of greater than 1.00D in either eye.
11. Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study.
12. Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye
13. Strabismus in either eye
14. Pupil or lid abnormality or infection in either eye
15. Central corneal scar and aphakia in either eye
16. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear
17. History of participation in clinical trials aimed to control myopia progression
18. Surgically altered eyes, ocular infection of any type, ocular inflammation
19. Subject has anterior chamber angle grade 2 or narrower
What Treatment Works for Children With Selective Mutism?

The purpose of this pilot study is to explore the outcome of a manual based treatment for children with Selective Mutism

Objectives:

The main aim of this pilot study is to increase our knowledge on interventions for Selective Mutism (SM), a childhood condition characterized by a persistent lack of speech in specific situations despite the ability to comprehend and use language. A survey on the treatment offered this group in Norway 1997-2000 showed great variations in therapeutic approach and the overall outcome was poor. Correspondent with the notion of SM as a variant of social anxiety, several case studies have described successful treatments using behaviour techniques (BT's) such as stimulus fading and shaping. In addition, the author's clinical experience is that "defocusing in communication" (e.g. regulation of gaze contact; sitting beside instead of in front of the child, avoiding direct questioning, talking about interesting but impersonal topics) represents another important toil in getting the mute child to start talking. However, to date there are no randomized controlled SM treatment studies, and in fact we know little of what works best to help these children. Our research group has developed an assessment- and treatment manual for children with SM.

In this exploring pilot study referred children with SM aged 3-5 years (n=7) will be given an intervention according to the treatment manual. The intervention is conducted at home and in the kindergarten or at school and includes stimulus fading techniques with weekly sessions. Therapists will be members of the research group or local therapist under supervision.

Eligibility Criteria:
Inclusion Criteria:

* Children with a clinical diagnosis of Selective Mutism (SM)

Exclusion Criteria:

* Children with Mental Retardation (IQ\<50)
* Children with Pervasive Developmental Disorder (PDD)
* Children with SM in active treatment
* Children with SM on medication
* Children whose parents are non-Norwegian speaking