cyrilzakka/clinical-trials huggingface dataset:
Avoidant and Restrictive Food Intake Disorders (ARFID) in Adolescence: Early Oral Development, Psychopathological Profile and Sensory Integration

The purpose of this study is to assess if adolescents affected with Avoidant and Restrictive Food Intake Disorders (ARFID) had more frequent precocious pediatric feeding disorders before 4 years old compared to healthy adolescents.

This research focuses on retrospective analysis of early pediatric feeding disorders seen for ARFID in adolescence in two departments of the DMU MEFADO.

This assessment will be implemented during a hospital visit by a questionnaire completed by the patient's parents covering the first years of the child's life in medical, behavioural and dietary terms. This questionnaire was created for this study and, therefore, is not validated for general population. The parents will also complete the Montreal Children Feeding scale based on their memories.

The Montreal Children Feeding scale is a validated parental self-questionnaire, allowing the screening of feeding and eating disorders in children under 6 years old. Since the study specific questionnaire is not validated, 60 non-ARFID controls will be included in the study for questionnaires completion. The research also focuses on the psychopathological profile of these adolescents with ARFID regarding their degree of anxiety, their degree of depression, their possible autistic traits and their sensory sensitivity. These aspects will be studied by validated self- and hetero-questionnaires standardized for these fields. The emotional expression of the parents will be assessed during a brief qualitative interview type "Five-Minute Speech Sample".

Eligibility Criteria:
Inclusion Criteria:

For all patients:

* Adolescent aged 12 to 18 (minors = 17 years 11 months)
* No opposition from parents and adolescent

For ARFID patients:

* Consulting at MDA or Necker for an ARFID diagnosed using DSM V criteria
* Whose first consultation for this disorder was less than 2 years ago

For non-ARFID patients:

* Consulting or hospitalized in orthopaedic surgery at Necker Hospital or Robert Debré Hospital for an acute traumatic reason
* Not diagnosed with a chronic illness

Exclusion Criteria:

For all patients:

- Parents and adolescents who do not speak French well enough to understand the questions on the scales and questionnaires

For ARFID patients:

- Diagnosis of autism spectrum disorder already made at the time of the consultation

For non-ARFID patients:

- Presence of a chronic organic or psychological illness, to limit the risk of including non ARFID patients at high risk of eating disorders
Bil. LR Rec. Using Standard Tables VS Reduced Numbers in Intermittent Exo. in Children Under 6

comparing the motor alignment and the incidence of postoperative esotropia following the correction of intermittent exotropia in children below 7 years by bilateral lateral rectus recession using the standard recession tables postulated by Parks versus correction using a reduced recession by one millimeter


Eligibility Criteria:
Inclusion Criteria:

* Patients with poor control intermittent exotropia (where poor control is defined as having a Newcastle score of 3 or more). (9)
* Basic, pseudo- divergence excess and divergence excess types are included.
* If associated with amblyopia it should be corrected before the surgical correction (where the visual acuity will be assessed by the single crowded HOTV test using a commercial projector).

Exclusion Criteria:

* Intermittent exotropia of the convergence insufficiency type.
* Intermittent exotropia with angle of deviation greater than 50 prism diopters.
* Patients with previous squint surgery.
* Patients with secondary deviation due to a sensory lesion or neurological condition.
A Study to Evaluate the Effect of Cyclosporine, a P-Glycoprotein, Breast Cancer Resistance Protein, and Organic-Anion-Transporting Polypeptide Inhibitor, on Pimodivir in Healthy Adults

The purpose of this study is to evaluate the effect of a single oral dose of cyclosporine on the pharmacokinetics of a single oral dose of pimodivir when coadministered to healthy adult participants under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to adhere to the prohibitions and restrictions specified in this protocol
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and on Day -1 of each treatment period
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after the last study drug intake
* A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person (male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak)
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after last study drug intake

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 90 milliliter per minute at screening), gastrointestinal disease (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* History of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
* Known allergies, hypersensitivity, or intolerance to pimodivir and/or cyclosporine or their excipients
* History of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
Cough Assist Device in Mechanically Ventilated Patients

Aspiration of respiratory secretions is a frequently needed procedure in intubated patients .

Cough is an important defence mechanism to clear mucus from the upper and lower airways . The presence of an endotracheal tube impairs the ability to cough.There are a number of techniques to mobilise sputum and optimise airway clearance for invasively ventilated patients. Endotracheal suctioning is the most common intervention used to remove retained airway secretions from within the endotracheal tube, trachea and upper airways .Mechanical insufflation-exsufflation (MI-E) aids sputum clearance from upper and lower airways. This technique augments inspiratory and expiratory flows to improve sputum mobilisation, through the application of rapidly alternating positive and negative pressure, which approximates a normal cough

Critically ill patients under invasive ventilation are at risk for sputum retention . Aspiration of respiratory secretions is a frequently needed procedure in intubated patients .

Cough is an important defence mechanism to clear mucus from the upper and lower airways . The presence of an endotracheal tube impairs the ability to cough. This prevents the enhancement of cough velocity . Furthermore, critically ill patients frequently have an impaired or no cough reflex due to depressed levels of consciousness, sedation, muscle weakness or muscle paralysis. Sputum retention, resulting from an inability to cough effectively, is one cause of extubation failure which in turn is associated with increased mortality.

There are a number of techniques to mobilise sputum and optimise airway clearance for invasively ventilated patients. Endotracheal suctioning is the most common intervention used to remove retained airway secretions from within the endotracheal tube, trachea and upper airways . Endotracheal suctioning though is not effective for clearing secretions from the lower airways .

New technologies and advanced methods have been developed to increase the effectiveness of mucus clearance in patients with acute respiratory failure, including mechanical insufflation-exsufflation devices. This technique has been described as an effective aid for mucus clearance in patients with chronic muscle weakness or neuromuscular disease.

Mechanical insufflation-exsufflation (MI-E) aids sputum clearance from upper and lower airways. This technique augments inspiratory and expiratory flows to improve sputum mobilisation, through the application of rapidly alternating positive and negative pressure, which approximates a normal cough .

Eligibility Criteria:
Inclusion Criteria:

Adult patients of both sexes on mechanical ventilation in RICU with any respiratory disease

Mechanically ventilated Patients without facial trauma

Mechanically ventilated Patients hemodynamically stable

Exclusion Criteria:

Patients diagnosed with barotrauma

Patients diagnosed with pneumothorax

History of bullous emphysema Known susceptibility to pneumothorax or pneumo-mediastinum
Indicators of Anastomotic Leak After Colorectal Surgery

We reviewed the patient underwent colorectal surgery with anastomosis and identified patients with anastomotic leak. Then we started to figure out what blood investigation could be related to anastomotic leak.


Eligibility Criteria:
Inclusion Criteria:

* Patient underwent colorectal surgery with anastomosis

Exclusion Criteria:

* Patient has no colon or rectum as part of anastomosis
* Patient with more than one procedure within 6 month
Safety and Immunogenicity of Typhax, a Typhoid Vaccine

This was a randomized, double-blind, ascending dose study conducted at a single clinical research center.

Healthy adult subjects aged 18 to 55 years were assigned to 3 ascending dose cohorts of Typhax (0.5, 2.5 or 10 mcg Vi antigen). Groups of 15 subjects in each dose cohort were randomized to receive Typhax, Typhim Vi (25 mcg Vi antigen) or placebo (saline) in a ratio of 3:1:1, respectively. Typhax and placebo (saline) was administered as two dose regimen (Days 0 and 28), and Typhim Vi was given as a single dose (Day 0) with matching placebo on Day 28. All doses were administered by a unblinded third-party as 0.5 mL by intramuscular (IM) injection. Safety and reactogenicity endpoints was assessed at 14 and 28 days after the first Typhax vaccination and 14 days after the second vaccination. Immunogenicity was assessed using an enzyme-linked immunosorbent assay (ELISA) to measure anti-Vi antibody serum titers on days 0, 14, 28, 42 and 180. A positive immune response (seroconversion) by ELISA is defined as at least a 4-fold increase over baseline in the Vi-specific ELISA.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men or women who are not pregnant or planning to become pregnant during study duration aged 18 to 55 years.
* Clinical laboratory parameters within normal laboratory limits or not found to be clinically significant by the PI

Exclusion Criteria:

* Relevant history of physical or psychiatric illness or medical disorder that required treatment.
* Known or suspected hypersensitivity to investigational product
* Immunocompromised subjects
* Previous Typhoid vaccination or elevated anti-Vi antibodies at screening
* Known history of Typhoid infection in the previous 6 months
* Positive HIV, HBsAg, or HCV screen
* Any other condition or abnormality that, in the opinion of the Investigator, may compromise the safety of the patients
Inhaled Tobramycin in BPD

This study is an open-label, phase 1, sequential dose escalation trial seeking to establish preliminary tolerability, efficacy, and pharmacokinetic data for up to 4 different doses of inhaled tobramycin administered to very preterm infants with BPD who are receiving invasive mechanical ventilation and have a pathogenic Gram-negative organism detected by tracheal aspirate culture.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female infants born \<32 weeks' gestation
2. Diagnosed with BPD (use of supplemental oxygen or respiratory support at 36 weeks postmenstrual age )
3. Postmenstrual age ≥36 weeks at study enrollment
4. Treatment with invasive mechanical ventilation at enrollment without planned tracheal extubation within 7 days after enrollment
5. Tracheal aspirate culture positive for one of the following pathogenic GNR bacteria within 7 days prior to enrollment: Pseudomonas aeruginosa, Klebsiella species, Enterobacter species, Stenotrophomonas maltophilia, Escherichia coli, Acinetobacter baumannii, or Serratia marcescens
6. Parental/guardian permission (informed consent).

Exclusion Criteria:

1. Serum creatinine \>0.4mg/dL within 14 days prior to enrollment
2. Congenital or acquired disease of the kidney or renal collecting system that adversely affects renal function
3. Congenital or acquired hepatobiliary disease that adversely affects liver function
4. Treatment with a systemic antibiotic within 7 days prior to enrollment
5. Treatment with a nephrotoxic medication, excluding diuretics, within 48 hours prior to enrollment
6. Treatment with a neuromuscular blocker within 48 hours prior to enrollment
7. Known intolerance to aminoglycoside antibiotics
8. Current treatment with high frequency or other oscillating mechanical ventilation
9. Presence of a cancer diagnosis
10. Maternal family history of early onset hearing loss defined as the need for an assistive hearing device prescribed before 30 years of age
11. Endotracheal tube leak \>20%.
12. Any prior use of an investigational drug \[as part of an FDA approved Investigational New Drug (IND) protocol\].
13. A subject who, in the judgement of the Investigator, is not an appropriate candidate for this research study.
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery

This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cataract surgery

Exclusion Criteria:

* Uncontrolled ocular disease in cataract surgery eye
Carotid Body Removal for the Treatment of Resistant Hypertension

This is a pilot study to assess the effectiveness, safety and feasibility of carotid body removal in patients with high blood pressure (hypertension) resistant to medical treatment. Patients with high blood pressure are at significant risk of medical complications including stroke and heart disease. The principle research question is whether removal of the carotid body will lead to an improvement in the blood pressure of this patient group.


Eligibility Criteria:
Inclusion Criteria:

* Age of participants will be 18-75 years
* Resistant HTN criteria:

  1. Daytime mean ambulatory systolic blood pressure ≥135mmHg and office systolic blood pressure ≥150mmHg
  2. Patients on at least three anti-hypertensive medications, including a diuretic, at maximum tolerated dose
  3. No evidence of causes for secondary HTN following thorough clinical assessment
  4. Patient medication concordance will be monitored via medication/blood pressure diary

Exclusion Criteria:

* Calculated GFR \<45ml/min/1.73m2
* Carotid body located outside the defined carotid septum
* Obstructive carotid atherosclerotic disease with \>50% stenosis
* Oxygen desaturation at rest below 92%
* Known structural lung disease
* Requirement for oxygen therapy to maintain oxygen saturation
* Patients wish to participate in mountain climbing, skin diving or free diving
* Pregnancy or anticipation of pregnancy
* Palliative care/chemotherapy
* Acute coronary syndrome or unstable angina
* Stroke or transient ischaemic attack (TIA) \< 6 months prior to procedure
* Expected life expectancy less than 12 months due to other disease
* Intravenous drug use
* Alcohol intake \>28 units/week
* Febrile illness within two weeks of participation
* Unable to attend for follow up appointments in Bristol at 1, 3, 6, 12 and 24 months post-operatively.

MR imaging related exclusion criteria (all participants):

* Pace-maker, implantable cardiac defibrillator, cerebral metallic clips or other implanted metal devices/structures
* Unable to tolerate scanner or history of panic attacks/claustrophobia
* Learning disability, significant hearing or visual impairment (participant would need to able to communicate from within the MRI scanner)
Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy

Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Woman 18 years
* Signed and written informed consent.
* Histologically confirmed squamous cell vulvar carcinoma
* World Health Organization performance status of 0-2
* Adequate hematological function
* Adequate hepatic function
* Adequate renal function
* Negative pregnancy test for woman of childbearing potential
* Histologically or CT scan confirmed metastatic squamous cell vulvar carcinoma
* Measurable disease
* Lesion previously not irradiated
* TNM stage any T any N M1

Exclusion Criteria:

* Vulvar cancer other than squamous cell carcinoma at biopsy
* Previous radiotherapy of the vulva, groins or pelvis
* Patients with metastasis limited to the pelvic lymph nodes, who can be primarily operated with curative intent
* Other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study
Application of Lung Near-Infrared Spectroscopy (NIRS) in Preterm Infants

Premature infants are more likely to develop hypoxemia after birth often requiring invasive and Non-Invasive Mechanical ventilation and surfactant therapy to improve alveolar gas exchange and oxygen transport. Near-infrared spectroscopy (NIRS) has been used to detect pulmonary regional oxygen saturation (rpSO 2 ) as well as cerebral regional oxygen saturation (rcSO2 ) and evaluate the oxygenation state of the lung and brain. This is a prospective observational study to evaluate utility of rpSO2 and compare it with rcSO2 in preterm infants born between 23-32 weeks of gestation receiving noninvasive ventilation and surfactant treatment. Enrolled patients will be continuously studied with placement of NIRS monitor using cerebral sensor (INVOS™) for 6 hrs and 15 min before and after surfactant administration. Pulmonary regional oxygen saturation (rpSO2) with a sampling interval of 6 s will be followed for 6hrs.


Eligibility Criteria:
Inclusion Criteria:

Infants born between 23-32 weeks of gestation admitted to the Neonatal Intensive Care Unit with respiratory distress receiving non-invasive ventilation and requiring Surfactant Replacement Therapy.

Exclusion Criteria:

Neonates with no need for respiratory support/Surfactant. Neonates with congenital malformations.
SpaceOAR System RWS in China

This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting the real word data of SpaceOAR System used, to generate local clinical evidence on Chinese patients.

This study is a retrospective and prospective, single arm, real world study. For those patients who have already received the SpaceOAR treatment before study kick-off, the data at baseline and the day of procedure will be retrospectively collected. For those patients who will receive SpaceOAR treatment after study kick-off, the clinical data at baseline, the day of procedure and 30 days post procedure will be prospectively collected.

Up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.

Eligibility Criteria:
Inclusion Criteria:

* Subjects has provided the written informed consent, willing to participate in clinical data collection and willing to receive visit at 30 days post procedure. (for subjects enrolled prospectively)
* Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated or will be treated with Space OAR Hydrogel in hospital in Hainan Boao Lecheng medical pilot zone.

Exclusion Criteria- no specific exclusion criteria unless the patients refuse to sign the informed consent.
Identification of Risk Factors for Atrial Fibrillation After Ablation of an Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.

Atrial flutter is a common condition that is effectively treated by ablation using radiofrequency. Due to its feasibility, effectiveness and low procedural risk, radiofrequency ablation is a first-line treatment of atrial flutter.

Several studies have been published concerning the factors associated with the occurrence of atrial fibrillation during or after flutter ablation, in patients with and without clinical history of atrial fibrillation. 26 to 46% of patients are likely to develop it, according to ECG or Holter diagnoses. The figure rises to more than 50% with a diagnosis with an implantable loop recorder.

In patients without a prior history of atrial fibrillation before ablation, anticoagulants are routinely administered 4-6 weeks after flutter removal by most cardiologists.

Although there are no specific guidelines for anticoagulation after flutter ablation, it is currently recommended to treat the patient as for atrial fibrillation. It is therefore crucial to identify in advance patients at high risk of atrial fibrillation after flutter ablation, in order to assess the appropriateness of maintaining oral anticoagulant therapy.

The objectives of this study are:

* to evaluate the frequency and identify the factors predicting the occurrence of atrial fibrillation after flutter ablation
* to determine the risk of a stroke occurring in patients with atrial fibrillation after flutter ablation.

The database consists in patients of the CHU Brugmann Hospital treated between 1996 and 2018.


Eligibility Criteria:
Inclusion Criteria:

Patients treated at the CHU Brugmann Hospital for flutter ablation by radiofrequency between 1996 and 2018.

Exclusion Criteria:

None