cyrilzakka/clinical-trials huggingface dataset:
Children's MRI Experience

The study aims to investigate the effect of Philips Ambient Experience with specially designed paediatric content on the experience of pediatric patients undergoing an MRI examination, their caregiver, and clinical staff, on workflow and on clinical outcome. The designed paediatric content exists of personal selection of a character, video projection on the wall and/or a screen visible when in the bore, audio, and room ambience lighting.

The study will be conducted in collaboration with six partner hospitals within the EU. At each hospital, 50 pediatric patients between 6 and 12 years old will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 6 and 12 years old
* Scheduled for a head-first MRI scan
* Parent/guardian and child speak and read the local language.
* Positive judgement by on-site PI/(co-) investigator for awake scanning

Exclusion Criteria:

* General anesthesia
* Clinically diagnosed cognitive, or developmental disorder (e.g. ADHD, ASD) or neurological problems that prevent the ability to lie/hold still for an MRI scan while awake
* Previous MRI examination with Philips Ambient Experience
Programmed Cell Death Protein-1 (PD-1) Monoclonal Antibody for EBV-HLH and CAEBV as First-line Therapy

EBV-HLH and CAEBV are both caused by EBV infection, part of them can rapidly lead to a syndrome of severe, life-threatening hyper-inflammation, with poor prognosis. Currently, the most effective treatment remains unknown. This study is trying to evaluate the efficacy and safety of PD-1 monoclonal antibody as a first-line therapy for EBV-HLH and CAEBV.

Eligible patients who were diagnosed with EBV-HLH or CAEBV, age between 12 and 70 years, were enrolled in this study. All of them need to sign the informed consent first.

PD-1 monoclonal antibody 200mg is infused intravenously once for patients whose age \>=18 years, or age \<18 years but weight \>=40kg. While for patients age \<18 years, the dose of PD-1 monoclonal antibody is 3mg/kg. Besides, optimal supportive care is necessary.

Ruxolitinib and/or low-dose glucocorticoid can be used to reduce inflammation.

Cerebrospinal fluid parameters are examined, and methotrexate 15mg combined with dexamethasone will be intrathecal injected without contraindications.

Clinical and laboratory indicators are investigated weekly to evaluate the efficacy and toxicity.

If patients achieve partial response/complete response within 14 days after PD-1 monoclonal antibody, the clinical observations are stopped. If not, the observation period is prolonged to 21 days.

If disease progress at day 21, this study is terminated, and the patient should be transfer to other treatments as soon as quickly.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of EBV-HLH or CAEBV.
2. Newly diagnosed patients.
3. Eastern Cooperative Oncology Group score 0-3.
4. Total bilirubin \<= 10 times of upper limit of normal (except for those caused by EBV-HLH or CAEBV), and serum creatinine \<= 1.5 times of upper limit of normal.
5. Serum HIV antigen or antibody is negative.
6. Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV-RNA is negative.
7. Both HbsAg and HbcAb for Hepatitis B virus (HBV) are negative. If not, the quantification of HBV-DNA needs to be \<1\*10e3 IU/ml.
8. The patient or his/her guardian must be able to understand and be willing to participate in this study, and sign the informed consent.

Exclusion Criteria:

1. Non EBV-HLH or CAEBV patients.
2. Refractory or relapsed EBV-HLH or CAEBV.
3. Heart function above grade II (NYHA).
4. Patients suffered from other uncontrollable active infections.
5. Pregnant or lactating women.
6. Patients with mental disorders and cannot cooperate with the requirements of research, treatment and monitoring.
7. Active visceral bleeding.
8. Allergic to PD-1 monoclonal antibody.
9. Patients with known autoimmune diseases.
10. Participate in other clinical research at the same time.
11. The investigator judges that the patient has other reasons not suitable for this study, or participating in the study will bring great risks to the patient.
Assessment Of Vascular Health After Niacin Therapy (AVANT)

This study is looking to see if niacin will lessen atherosclerotic plaque inflammation and favorably affect circulating levels of endothelial progenitor cells and microparticles in people with atherosclerotic disease on chronic statin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Men age 55 years and above with coronary artery disease or women age 65 years and above with coronary artery disease OR Men age 45 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease or women age 55 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease.
* Subjects must be on statin monotherapy, defined as a stable statin dose for at least 12 weeks, with no anticipated need for further titration during the study period

Exclusion Criteria:

* Anxiety or claustrophobia prohibiting imaging
* History of allergy to intravenous contrast, iodine, or shellfish
* Renal insufficiency
* History of allergy or severe intolerance to niacin
* History of diabetes mellitus or elevated fasting glucose
* Moderate to severe gout
* Peptic ulcer disease
* Acute coronary syndrome, transient ischemic attack or cerebrovascular accident, or acute limb ischemia in the preceding 12 months
* Heart failure or unstable angina pectoris
* Use of daily non-statin lipid-altering therapy prior to the initiation of study medication
TReatment by Insulin Continuous Infusion in Type 2 DIAbetes

The aim of the TRICIDIA2 study is to compare two modalities of administration of insulin.

In our future study, the investigators wish to study if the treatment by continuous infusion of insulin improves the insulinosensitivity of type 2 diabetic patients; the investigators indeed expect that the insulin delivered in a continuous way decreases the insulino-resistance of these patients compared with the intermittent delivering of insulin.

We wish to use before and after treatment the classic tools of measure of insulinosensitivity / the euglycemic hyperinsulinemic clamp associated with a measure of the insulinosecretion thanks to a test of load in glucose IV. The coupling in the same procedure of these 2 tests is the Botnia clamp. We also wish to use the continuous measure of subcutaneous glucose during several days to estimate the reduction in the average glycemia on the fast and prandial periods as well as the decrease of the time spent in hyperglycemia during the day. This tool demonstrated its interest in type 2 diabetic population in several studies. Finally the current / spectro-IRM methods of imaging are now validated to quantify and measure exactly the importance of the steatosis, including in type 2 patients, because we know that it is probably the result of the insulino-resistance; We would also like to demonstrate that some genetic polymorphisms of proteins (polymorphisms G / T493 of the MTP, 1927 C/T of the receiver R1 of the adiponectin and 265 C/T of the gene of Apolipoprotéines A) are factors which can modulate the steatosis development in case of type 2 diabetes.

In other secondary criteria we wait for an improvement of HbA1c, quality of life of type 2 obese people with regard to the treatment by intensified Multi-injections.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* type 2 diabete patient with insuline basal/bolus treatment for at least 6 months
* Doses of insuline \> 0,7 U/Kg/j
* HbA1c ≥ 7,5%
* without ADO for at least 4 weeks (sulfamides, Incrétines, glinides, acarbose) except the metformine
* BMI ≥ 28,5 kg/m²
* clinical diagnostique of diabetes for at least 10 ans
* Patient must be able to Realize an automonitoring and to manage the functioning of an insulin pump.

Exclusion Criteria:

* glitazone treatment less than 3 month before inclusion
* Patient with an untreated by the laser proliferative ischemic retinopathy
* BMI \< 28,5 kg/m²
* Pacemaker (CI IRM)
* Presence of implantable material (CI IRM)
* Pregnancy, breast-feeding
* Practices of violent sports
* Professional extreme environment of cold or heat
* Serious psychiatric diseases physical and/or psychiatric Incapacitated medically significant
* Poor sanitation
Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

The heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the parasympathetic nervous system and a decrease of the sympathetic system. Various explanations of this these dysfunctions are proposed in literature, mainly malnutrition, physical hyperactivity, anxiety, that are known characteristics of anorexia nervosa.

The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety in anorexia nervosa.

Other objectives of this study are firstly to evaluate correlation between ANS dysfunction and others parameters (weight, body mass index, depression, physical activity, purgative ou restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if HRV is a predictive parameter of the evolution of anorexia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Aged from 18 to 65 years
* Criteria of anorexia nervosa (DSM V)
* Body mass index (BMI) \< 18 kg/m2
* Written consent to participate in the study
* Patient affiliated to a social security system

Exclusion Criteria:

* Pacemaker or other implantable electronic device
* Current comorbidity psychiatric disorder according to Axis I of DSM IV : severe depression (BDI \> 8/13), substance use disorder .
* Psychotropic drugs or ongoing steroid therapy ;
* Pregnancy or breast-feeding ;
* History or known cardiovascular disorder, including hypertension ( \> 140/90 mmHg ) , heart failure, arrhythmia and conduction disorder .
* Major protected by a legal protection
* Minors
* Patient involved in another research with an exclusion period ongoing at the run-in
Effect of Glycemic Index on Physical Capacity in Runners

The purpose of the present study was to assess the influence of low vs moderate glycemic index of a 3-week diet on aerobic capacity, endurance performance and body mass and composition in endurance-trained athletes in a randomized, controlled crossover trial.

The effect of glycemic index of pre-exercise meal on endurance capacity and performance has been widely investigated. However, little is known about the adaptations to longer dietary interventions with different glycemic index and their influence on aerobic capacity and body composition in runners. Therefore, the purpose of this study was the assessment of the influence of low GI vs moderate GI of a 3-week diet on aerobic capacity, endurance performance and body mass and composition in endurance-trained athletes in a randomised, controlled crossover trial.

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate,
* male and female,
* a current medical clearance to practice sports,
* training experience: at least 3 years,
* minimum of 4 workout sessions a week lasting at least 1.5-2 hours/day,
* age: 17 - 37 years.

Exclusion Criteria:

* current injury,
* any health-related contraindication,
* declared general feeling of being unwell,
* unwilling to follow the study protocol,
* smoking, illicit drug use, alcohol consumption greater than 1-2 drinks/week, dietary supplements use less than 3 weeks before the study,
* females- being pregnant or planning to become pregnant during the study.
The Effect of A-PRF+ Versus Open Flap Debridement in the Treatment of Patients With Stage III Periodontitis

To assess the effectiveness of advanced PRF+ as compared to open flap debridement in treatment of periodontal intraosseous defects in stage III periodontitis patients.

The application of platelet concentrates characterized by high concentrations of platelets and growth factors have been applied and investigated as possible periodontal regenerative therapy. The application of platelet rich fibrin in management of intraosseous and furcation defects produce more favorable outcome compared to open flap debridement.

A-PRF+ represents the latest generation of platelet concentrates that could provide sustained and increased release of growth factors and could serve as an autologous cost-effective membrane in periodontal tissue regeneration procedures

Eligibility Criteria:
Inclusion Criteria:

* Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
* Defect not extending to a root furcation area
* Non-smokers.
* No history of intake of medications affecting the periodontium in the previous 6 months.
* Able to sign an informed consent form.
* Patients age between 18 and 60 years old.
* Patients who are cooperative, motivated, and hygiene conscious.
* Systemically free according to Cornell Medical Index (Broadbent, 1951).

Exclusion Criteria:

* Pregnancy or breast feeding
* The presence of an orthodontic appliance
* Teeth mobility greater than grade I
Anticoagulation Management in Complex Cardiac Surgery

The goal of this clinical trial is to compare the anticoagulation management with or without heparin concentration level guidance, in patients undergoing valve or complex cardiac surgery during cardiopulmonary bypass using closed, coated circuits. The main questions it aims to answer are:

* initial heparin bolus, subsequent supplementary doses and total heparin variance among groups.
* protamine dose among groups.

Participants are adult patients scheduled for valve or complex cardiac surgery. They are randomised to either Activated Clotting Time guided management alone or combined with heparin level concentration monitoring.


Eligibility Criteria:
Inclusion Criteria:

* elective procedures
* cardiac surgery, except for Coronary Artery Bypass Grafting
* Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation

Exclusion Criteria:

* known allergy to heparin or protamine
* hematological disease
A Study of Optical Fusion Trans-Perineal Grid

The purpose of this research is to evaluate a new needle guide grid utilizing Clear Guide SCENERGY - MR with a grid embedded with VisiMARKER II to autoregister and target the prostate aiding in needle placement positioning. The proceduralist can utilize this technology to find the best needle path to target within the pelvis.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a MR guided biopsy or ablation.
* One, two, or three tumor suspicious regions identified on multiparametric MRI.
* Tolerance for anesthesia/sedation.
* Ability to give informed consent.

Exclusion Criteria:

* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
* History of other primary non-skin malignancy within previous three years.
Effect of Energy- and Protein-rich Foods on Physiological Functions and Quality of Life in Undernourished Patients

The purpose of this study is to determine whether individualised nutritional therapy comprised of appetising, energy- and protein-rich foods can have a positive effect on physiological function and quality of life of undernourished patients as compared to usual nutrition care.

Undernutrition and insufficent dietary intake in hospitalised patients is a widespread problem. It is associated with increased morbidity and mortality, worsened physiological function and quality of life and increased expenses for the health care system. Food quality has been shown to be positively associated with dietary intake in patients. However, there has lacked knowledge on how food quality can be optimised to promote intake. A project was therefore initiated, which aimed at establishing a framework for developing appetising, energy- and protein-rich foods for patients at nutritional risk. This project included qualitative and quantitative investigation of nutritional risk patients' meal experiences and preferences (se citations below). These results have served as a basis for optimsing energy- and protein-rich foods as part of an indivudalised nutritional therapy aimed at improving dietary intake in nutritional risk patients.

Eligibility Criteria:
Inclusion Criteria:

* Nutritional risk as per Nutrition Risk Screening 2002 (NRS-2002)
* Hospital admited at Rigshospitalets (various medical departments)
* Expect length of stay \>= 5 days
* Informed consent to participate

Exclusion Criteria:

* Dementia or other psychiatric condition resulting in an inability to give informed consent and to understand study materials.
* Inability to fairly perform the functional measurements (i.e., handgrip strength, reaction time) due to a hand, wrist, arm, shoulder injury or condition.
* Enteral or parenteral nutrition as primary nutritional therapy.
* Previous participation in the study.
A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease

To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for Japanese subjects with intestinal Behçet's disease who are refractory to conventional therapies.


Eligibility Criteria:
Inclusion Criteria:

* Intestinal Behçet's disease
* Patients with typical ulcer at ileocecal region
* Patients who have failed conventional treatment

Exclusion Criteria:

* Crohn's disease
* History of ileocecal resection
* History of tuberculosis (TB)
* Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study
HPV Prevalence in the Mouth and Oropharynx of the Tonsillectomy Population

The principal aim of this study is to provide vital current data on the prevalence, distribution and natural history of Human Papilloma Virus (HPV) infection in the mouth. This data is an essential requirement for the assessment, development and evaluation of cost effectiveness of prophylactic vaccination and screening programmes.

Patients undergoing a tonsillectomy operation for non-cancerous reasons will be recruited for this study. They will be asked to complete two questionnaires (study and sexual practices), provide saliva, urine and a blood sample. Following anaesthesia, oropharyngeal brushings and a tonsillectomy will be performed and all the samples will be processed for evidence of HPV infection.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects undergoing tonsillectomy for non cancer reasons including operations for: recurrent tonsillitis, asymmetric tonsils, snoring surgery or obstructive sleep apnoea
2. Age - 0 to 65 years
3. Subject or legal guardian has given informed written consent

Exclusion Criteria:

1. Subjects undergoing adenoidectomy alone with no tonsillectomy
2. Subjects with previous oropharyngeal cancer or oral cancer, or any other head and neck cancer such as nasopharyngeal or laryngeal cancer that is currently undergoing or has previously been diagnosed or treated
3. Learning disability preventing an adult over 16 years old from giving their own consent
Efficacy of Blue Wavelength in Managing Dry Eye

The study is conducted to evaluate the efficacy of digital blue light blocking filter in improvement of clinical indices of dry eye and ocular symptoms related to dry eye.

Introduction: Dry eye disease is a multifactorial disease of the ocular surface caused by loss of tear film homeostasis resulting damage to the ocular surface and neurosensory abnormalities.

60 subjects aged 20-35 years with ocular surface disease index score greater than 13 will be taken from the University of Faisalabad. After taking consent, procedure starts from history then Schirmer test 1 will be performed to measure the tear deficient dry eye. Tear break up time will be done to assess the evaporative dry eye. Corneal surface staining will be used to measure corneal erosions. OSDI questionnaire will be used for the evaluation of ocular symptoms related to dry eye. The digital blue light blocking filter will be randomly installed in digital devices of the 80 subjects and rest of 80 will be without filter. After baseline data follow ups will be after 3 weeks and second after 8 weeks of filter use. Schirmer test 1, tear break up time corneal surface staining and OSDI will be performed on both groups (filter users and non-filter users) for the evaluation of dry eye. Data will be analyzed using SPSS version 21. Result of this study will give knowledge that use of digital blue light blocking filters are useful in the management of dry eye disease.

Eligibility Criteria:
Inclusion Criteria:

* Females with age 20-35years
* using digital devices androids and laptops
* Ametropia of up to 1.0 Diopter sphere(DS) and astigmatism of less than 0.5
* Emmetropes.

Exclusion Criteria:

* Subjects using topical drugs
* Smokers
* Subjects undergoing dry eye treatment
* History of contact lens wear within the past three months
* Corneal surface disease other than dry eye
* Corneal or eyelid infections
* Corneal surgeries
* Refractive error of more than 1 DS of SE and astigmatism of greater than0.5DC
* Age \<18 and \>3 years
* Subjects already using blue light blocking filters
* I phone users
* Pregnant women
* Males
Exploratory Study: COVID-19 and Pregnancy

The SARS-CoV-2 infection may behave differently in pregnant and postpartum women in the short and long term. Several risk factors or medication use can interfere on disease' evolution and vertical transmission. Thus, due the current pandemic and the scarcity of scientific studies involving pregnant women with covid-19 or positive serology, combined with the need to elucidate the behavior of this viral infection in pregnant women in our population, this study aims to evaluate the clinical and laboratory evolution, transplacental passage, gestational and neonatal outcomes in pregnancies with positive SARS-CoV-2.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with clinical symptoms or positive serology for SARS-CoV-2 hospitalized or in delivery time;
* Asymptomatic pregnant women for SARS-CoV-2 during pregnancy and hospitalized for delivery at HU-USP.
* Pregnant women diagnosed with SARS-CoV-2 prior to delivery and who, after the quarantine period, followed prenatal care and delivered at the HU-USP or HCFMUSP.

Exclusion Criteria:

* Non-confirmation of maternal SARS-CoV-2 infection in pregnant women hospitalized or in delivery time.
* Withdrawal of pregnant woman to continue in the study.
Epidural Waveforms: Pressure Transducer vs CompuFlo

The purpose of this single arm, open label study will be to compare and evaluate the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space when compared to the standard pressure transducer.

40 patients who had an epidural functioning catheter previously positioned for anesthesia or analgesia will be enrolled. After removing the epidural filter and after having zeroed the instrument, the investigator will connect in a random fashion sequence, a standard pressure transducer attached to a standard invasive blood pressure monitor or to the CompuFlo CathCheck instrument to observe and record the occurrence of epidural pulsatile waveform.

The investigator will also note and evaluate:

The volume of saline priming necessary to obtain the waveform The effects of patient's position on the occurrence and amplitude of epidural pulsatile waveform

Eligibility Criteria:
Inclusion Criteria:

* patients with an epidural lumbar catheter for anesthesia or analgesia

Exclusion Criteria:

* patients with malfunction or dislodgement of the epidural catheter