cyrilzakka/clinical-trials huggingface dataset:
Cohort of Healthy People in Brain MRI, Together With a Language and Cognitive Assessment at the University Hospital of Nice

The aim of this study is to constitute a cohort of healthy subjects in brain MRI, including functional and diffusion sequences, together with a language and cognitive assessment. This will make it possible to compare the data with those obtained in the same center and under the same examination conditions in brain tumor patients. The investigators seek to evidence general patterns of cerebral morphological and functional changes, correlated with behavioural scores, in brain-damaged patients.


Eligibility Criteria:
Inclusion Criteria:

* cerebral and psychiatric healthy volunteer
* agreeing to participate in this research
* 30 and 50 years old or between 60 and 75 years old

Exclusion Criteria:

* contra-indication to MRI
* refusal of patient participation
* pregnant, lactating or parturient women
* vulnerable people
Sedation Versus Protective Stabilization for Pediatric Dental Treatment

There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in the Brazilian context despite moral questions. The objective of this prospective nonrandomized clinical trial is to evaluate the effectiveness of the use of moderate sedation, compared to the protective stabilization, in the dental care of children with fear / anxiety and / or dental behavior problem, and associated factors. The study will be carried out in outpatient clinics of the Dental Schools of the Federal University of Goiás (UFG) and University of São Paulo (USP), with the support of professors from King's College London through the partnership CEDACORE - Children Experiencing Dental Anxiety: Collaboration on Research and Education. Participants will be 152 children under 7 years of age with dental caries, who need specialized dental treatment due to a history of non-cooperation with dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam (UFG) and protective stabilization (USP). The primary endpoint 'behavior / anxiety of the child during treatment will be assessed using the Ohio State University Behavioral Rating Scale. The secondary outcomes are: dental behavioral and anxiety evolution of the child, child' pain during procedure, impact on the quality of life related to oral health, parents and dentists' satisfaction and stress, adverse events for sedated participants, longevity of composite and glass ionomer cement restorations, chronotype and physiological stress of these children. A cost-efficacy analysis will be produced at the end of the study from the perspective of the Sistema Único de Saúde. Additionally, at the end of 36 months, the investigators expect to contribute to the identification of psychosocial aspects related to dental behavior problems in children in early childhood. It is important to highlight the perspective of technological innovation, with the creation of a digital platform that will allow the registration of data related to the dental care of children worldwide and favor analyzes in the methodology of data science.


Eligibility Criteria:
Inclusion Criteria:

* Children presenting cavities that need dental restoration
* ASA I (healthy) or II (mild and controlled systemic disease - persistent asthma, for example) children (ASA, 2015)
* Medical history without neurological or cognitive impairment
* Children who do not use medicines that may impair cognitive functions
* Children at low risk for airway obstruction (Mallampati less than 2 and / or tonsil hypertrophy occupying less than 50% of the oropharynx) (Mallampati et al., 1985)

Exclusion Criteria:

* Children with positive or definitely positive behavior (Frankl et al. 1962) in the dental examination session
* Non-attendance at the first intervention appointment after three scheduling attempts
* Chronic use of systemic corticosteroids
A Study to Assess the Effects of Multiple Doses of Fidaxomicin on a Single Dose of Rosuvastatin in Healthy Male Subjects

This study will assess the effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin in healthy male subjects. Determine the safety and tolerability of multiple doses of fidaxomicin in the presence of a single dose of rosuvastatin in healthy male subjects. Also determine the pharmacokinetics of multiple doses of fidaxomicin and its metabolite OP-1118.

Sequence 1:

Thirteen subjects receive an oral dose of rosuvastatin on Day 1 in Period 1 and on Day 13 in Period 2 and twice-daily oral doses of fidaxomicin on Days 8 to 17 in Period 2, according to the following treatment schedule:

* Period 1: Subjects receive a single oral dose of rosuvastatin on Day 1, followed by a 5-day pharmacokinetic (PK) sampling period.
* Period 2: The same subjects receive fidaxomicin twice daily for 5 days (Days 8 to 12). On Day 13, a single oral dose of rosuvastatin and an oral dose of fidaxomicin is administered simultaneously in the morning. Twice-daily treatment with fidaxomicin continues until the end of Day 17. Subjects are discharged on Day 18 when all assessments are performed and if there are no medical reasons to prolong the stay.

Sequence 2:

Thirteen subjects receive an oral dose of rosuvastatin on Day 6 in Period 1 and on Day 14 in Period 2. Oral doses of fidaxomicin are administered twice daily for 10 days in Period 1, according to the following treatment schedule:

* Period 1: Subjects receive fidaxomicin twice daily for 5 days (Days 1 to 5). On Day 6, a single oral dose of rosuvastatin is administered simultaneously with an oral dose of fidaxomicin in the morning. Twice daily treatment with fidaxomicin continues until the end of Day 10.
* Period 2: Subjects receive a single oral dose of rosuvastatin on Day 14, followed by a 5-day PK sampling period. Subjects are discharged on Day 19 when all assessments are performed and if there are no medical reasons to prolong the stay.

In both sequences, subjects return to the clinical unit for an End of Study Visit (ESV) 7 to 14 days after (early) discharge.

Eligibility Criteria:
Inclusion Criteria:

* The subject has a Body Mass Index (BMI) range of 18.5 to 30.0 kg/m2. The subject weighs at least 50 kg at Screening.
* Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after final study drug administration.
* The subject must not donate sperm starting at Screening and through-out the study period and for at least 90 days after final study drug administration.

Exclusion Criteria:

* The subject has a history of or current Clostridium difficile infection.
* The subject has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
* The subject has an irregular defecation pattern.
Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects

The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy subjects.

These results will be compared with data obtained out of episode in patients with Kleine-Levin syndrome (KLS).

The investigators want to determine if brain functional imaging and cognitive abnormalities persist during asymptomatic period in a large series of patients with KLS, and to find predictors of these abnormalities.

3 steps in the protocol :

* Brain ECD-SPECT (marking brain perfusion in relation to brain active/hypoactive area) superimposed on a template T1-weighted brain MRI.
* Extensive cognitive tests of executive functions, verbal memory and fluency , visuospatial ability and memory, reasoning abilities: spontaneous memory complaint, Stroop Color Word Test, Trail Making Test A and B, Direct and Reverse Digit Span Test, Letter and Semantic Fluency Test, Free and Cued Selective Reminding Test, Rey-Osterrieth Complex Figure, Mini-Mental test, Progressive matrice of Raven (PM-38)
* KLS-inventory and face to face interview of patients and parents by neurologist for patients. Modified KLS-inventory for healthy subjects.

Main outcome : Number of patients with persisting hypoperfused brain area (compared to controls), location of these area, number of patients with at least -1SD in one cognitive domain Correlation between KLS severity (disease course, number of episode, mean duration of episodes, time incapacitated, number of symptoms) and brain perfusion and cognitive abnormalities

Eligibility Criteria:
Inclusion criteria :

* Subjects males and females with more than 18 y.o, age and sex-matched with patients with Kleine-Levin Syndrome
* with the same educational level and dominant hand than patients with Kleine-Levin Syndrome
* without any brain disease or sleep disease (Epworth score \< 11/24) known.
* with social security
* french language
* for women : nonpregnant taking effective contraception

Exclusion criteria :

* Minor subjects
* adults under protection
* subjects with neurologic, psychiatric, somatic or sleep diseases and/or receiving a psychotropic medication interfering with the results.
* subjects with history of seizures or loss of consciousness
* subjects with excessive alcohol consumption (more than 3 doses /day)
* subjects without any social security
* subjects non fluent in french
* for women : no effective contraception or lactation period
Efficacy and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology

Haemorrhoids are composed of tissue rich in blood vessels and are present in all individuals inside the anus (internal haemorrhoids) or under the skin of the anus (external haemorrhoids). Haemorrhoidal disease (HD) occurs when haemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or oozing. In case of failure of medical treatment, instrumental procedures or extensive disease, surgical treatment can be considered. There are two classic surgical techniques. The first is the pedicle haemorrhoidectomy of the Milligan and Morgan type. The second classic surgical technique is the Longo stapled anopexy. Recently, less invasive surgical techniques such as arterial ligation (HAL, with or without Doppler) followed by recto-anal repair (RAR for "Recto Anal Repair") and sometimes associated with mucopexy, which allows the excess mucosa to be ligated and the muco-haemorrhoidal tissue to be fixed to the rectal wall, have developed. The use of radiofrequency current (Rafaelo technique) in the treatment of haemorrhoidal disease is an innovative technique of haemorrhoidal thermocoagulation. It is a mini-invasive technique, which can be performed under sedation or short general anaesthesia (GA), with little pain, allowing a rapid return to normal life and a short time off work. Although this technique is already used in other European countries: Poland, Germany, Belgium, Great Britain (UK), there is now a Polish, German, Spanish and English study in the process of publication. There have been no studies in France to evaluate this new technique and assess its good tolerance, the duration of work stoppage, the improvement in quality of life and the evaluation of its effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female consulting for hemorrhoidal pathology (grade II or III) after failure of medico-instrumental treatments.
* Age ≥ 18 years and \< 75 years
* Mandatory affiliation to a health insurance system.
* Patient having been informed of the study and having given informed consent

Exclusion Criteria:

* Patients with chronic inflammatory bowel disease
* Patients with suspected gastro-colic pathology
* Haematological diseases
* Anal fistulas
* Patients unable to discontinue anti-vitamin K or oral anticoagulants
* Associated anal fissure
* External haemorrhoidal disease
* Pregnant or breastfeeding women
* Patients under legal protection
Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma

Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary endpoint of the study is the response rate and Quality of Life of the patients (QoL).

Response is planned at 21-day after completion of the treatment. Response assessment is based on the standard definitions of the World Health Organization using complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) as response assessment criteria. The efficacy of the treatment consisted of a reduction greater than 50% of the maximum diameter of the radiated mass (PR + CR). QoL is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 3.0 version questionnaire. The QLQ-C30 questionnaire is self administered to the patients at baseline and at 21 days after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven diagnosis of DLBCL with indication for palliative radiotherapy

Exclusion Criteria:

* None
A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the Rome III Diagnostic Criteria
* Loose (mushy) or watery stools within the last 3 months

Exclusion Criteria:

* Patients having hyperthyroidism or hypothyroidism
Robot-assisted IVOR-LEWIS Esophagectomy

Minimally invasive esophagectomy (MIE) have become increasingly popular in esophageal cancer. It is generally accepted that comparing to open resections, MIE results in decreased postoperative pain, faster recovery times, and shorter hospital stays with comparable oncologic outcomes. However, MIE poses an important challenge for established thoracic surgeons as it is a difficult technique to become skilled at with an protracted learning curve. Standard laparoscopic and thoracoscopic instruments are rigid and provide a finite freedom of movement with a two dimensional visualization of the operating field. Such a difficulty is increased even more when the Ivor-Lewis esophagectomy with an intrathoracic anastomosis is needed.

Robot- assisted surgical system has opened a new era of minimally invasive surgery. Robot- assisted surgery offers some advantages including high- definition three- dimensional visualization and 7 degrees of freedom with the use of its surgical wrists, motion scaling, and tremor filtration, allowing the surgeon to perform complex operations comfortably in the domain of urinary tract, hepatobiliary and gynecological surgery. Although a robot-assisted thoraco- laparoscopic minimally invasive esophagectomy (RAMIE) was initiated from 2003, the published experience with RAMIE remains small, especially for Ivor- Lewis approaches. The aim of this study was to investigate the short- term and long-term outcomes of RAILE to identify any clinical or oncologic benefits of RAILE in esophageal cancer.

This confirmatory, nonrandomized, single-arm trial (phase II) will be conducted to evaluate short-and long-term outcomes of robot-assisted thoraco- laparoscopic minimally invasive esophagectomy for esophageal cancer. Patients will registered preoperatively. The planned sample size was 51. Preoperative endoscopic biopsy was performed in all patients to confirm the histological diagnosis of esophageal cancer. Staging workup included thorough history and physical examination, esophagogastroduodenoscopy, endoscopic ultrasonography, and integrated positron emission tomography/computed tomography scan. Patients with histologically proven malignancy were candidates for surgical procedures. Operability criteria were defined according to the National Comprehensive Cancer Network guidelines. All patients were within the American Society of Anesthesiologists (ASA) class I to III. In general, neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease. The primary endpoint in the first stage is the short-term postoperative complications, and that in the second stage is overall survival; patients continue to be followed up for this endpoint.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically proven esophageal malignancy
2. All patients were within the American Society of Anesthesiologists (ASA) class I to III
3. neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease

Exclusion Criteria:

Cancer located at the cervical esophageal Cancer located at the gastroesophageal junction history of surgery in the right thorax
Lung Function Monitoring During Hypoxemia Episodes

Premature infants commonly have desaturation episodes due to different reasons such as cessation of breathing or loss of lung volume. The purpose of this study is to differentiate the mechanisms of desaturation episodes with continuous lung volume monitoring. As we better understand the mechanisms underlying the desaturation episodes, newer strategies directed at underlying pathophysiology can potentially by evaluated for mitigation of these episodes.

This is an observational study evaluating changes in lung volume during hypoxemia episodes (HEs or desaturation episodes) in spontaneously breathing very preterm infants. We postulate that HEs can be differentiated into distinct subtypes based on alterations in lung volume. Additionally, the severity and duration of HEs correlates with the degree of changes in lung volumes. Therefore, we are performing an observational study in very preterm infants with spontaneous HEs and classifying these episodes into different subtypes of Apnea, forced exhalation, mixed, and unclassified subtypes according to changes in lung volume. Lung volume will be measured non-invasively using electrical impedance tomography (EIT) device (Sentec Inc, RI, USA). In brief, the device consists of a soft belt with 32 embedded electrodes which is placed around the chest of the infant and applies a weak alternating current and measures returning voltage. The measured returning voltage is dependent on the electrical conductivity of the underlying tissue. The reconstruction algorithm creates an image of regional impedance distribution in real time. These data are then used to compute lung volume parameters at different phases of respiratory cycle providing end expiratory lung impedance reflective of EELV, tidal impedance reflective of tidal volume, and regional distribution of ventilation. The changes in lung volume parameters will be used to differentiate HEs into different subtypes and correlated with degree and severity of HEs. In addition, we will also measure cerebral tissue oxygen saturation (CrSO2) to monitor changes in tissue oxygenation with hypoxemia episodes and changes in lung volume.

Eligibility Criteria:
Inclusion Criteria:

* Born at ≤32w GA
* Post menstrual age between 30w to 36w
* 4 or more episodes of HEs in the previous 24h (Defined as SpO2\<90≥5s)

Exclusion Criteria:

* Major congenital malformation
* Receiving invasive mechanical ventilation
* Severe neurological injury
* Hemodynamic instability requiring inotropes in last 72h
Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye

This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of AGN-232411 topical ophthalmic solution in healthy participants and participants with dry eye.


Eligibility Criteria:
Inclusion criteria:

Stage 1

-Healthy participants.

Stage 2 -Participants with the symptoms of dry eye disease.

Exclusion criteria:

Stage 1

-Known allergies or sensitivities to study medications, fluorescein, or lissamine green

Stage 2

* Known allergies or sensitivities to study medications, fluorescein, or lissamine green
* Allergic ocular disease, ocular trauma, corneal erosions or ulcers, or uveitis within the previous 12 months
* History of any ocular surgery within the previous 12 months.
Health Economic Analysis of Islet Cell Transplantation for the Stabilization of the Severe Forms of Type 1 Diabetes

The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented pump therapy) for patients with brittle type1 diabetes.

The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented insulin pump therapy) for patients with brittle type1 diabetes.

Eligibility Criteria:
Inclusion Criteria :

* Suffering from diabetes since more than 5 years
* Patient with brittle type 1 diabetes despite an optimized insulin treatment and educational training will be included. A patient will be considered as experiencing a brittle type 1 diabetes if at least two criteria are present among: persistence of severe hypoglycemia, occurrence of ketoacidosis events without obvious etiology, diagnosis of unaware hypoglycemic episodes \< 3 mmol/l based on CGM or self-monitoring blood glucose data, a mean blood glucose standard deviation\>50%, MAGE index (Mean amplitude of glucose excursions)\>60 mg/dl, LBGI index (low blood glucose index)\>5, Clarke score≥4 or HYPOSCORE\>800.
* Insulin needs \< 0,85 U/kg/day
* HbA1c \< 12% ;
* No residual insulin secretion (plasmatic basal and stimulated C-peptide \< 0.3 ng/ml)
* Social Security membership or benefit from Social Security
* Patients who signed the consent form

Exclusion Criteria :

Exclusion criteria related to islet infusion:

* Hemostatic disorders, pre-existing liver disease (PAL, Gamma-GT, ASAT-ALAT \>2N) or vesicular lithiasis.

Exclusion criteria related to diabetic complications:

* Evolutive proliferative retinopathy, evolutive nephropathy (Glomerular filtration rate \<30 ml/min/1.73m2 and/or proteinuria \>0.5g/day), evolutive cardiopathy or obliterative arteriopathy with trophic cutaneous lesions.

Exclusion criteria related to immunosuppressant use:

* Hemoglobin \< 110mg/dL in women and \< 120 mg/dL in men, leuconeutropenia, thrombopenia, systemic infection including chronic hepatitis B, C and VIH, neoplasia disease and hypertension\>160/100 mmHg.
* Corticoid treatment (except for patient that benefited from a kidney graft with maintenance steroid therapy)
* Presence of anti-HLA antibody directed against the donor
* Positive B or T cells crossmatch