cyrilzakka/clinical-trials huggingface dataset:
Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression

There is relatively insufficient evidence on whether rTMS can improve suicidal ideation in depressive patients. And existing studies have been inconsistent in the treatment of depressive suicidal thoughts. The possible reason is inaccurate stimuli localization. Improving the accuracy of rTMS stimulus positioning may further improve the intervention effect of suicidal ideation. This study will introduce an automated TMS system with robot control and optical sensor combined with neuronavigation softwarea. By using the robot based on neuronavigation system, the rTMS coil can be accurately positioned over any preselected brain region. An infrared optical measurement device is also used in order to detect and compensate for head movements of the patient. The purpose of this randomized double-blind and sham-controlled study is to test the efficacy and safety of robot-assisted rTMS based on neuronavigation in the treatment of depressive suicidal ideation.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years
* meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
* have a score \> 17 on the HAMD-17
* have a score ≥ 6 on the BSI-CV
* right- handedness
* physical examination, medical history, vital signs, blood routine, liver and kidney function, ECG, EEG and other indicators are normal
* are voluntary and competent to consent to treatment

Exclusion Criteria:

* People with a history of severe physical illness and depression caused by psychoactive substances and non-dependent substances
* Patients with metal or electronic equipment, such as intracranial metal foreign bodies, cochlear implants, pacemakers and brace, etc.
* Risk of seizures, previous central nervous system diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of abnormal brain structure, or family history of epilepsy
* Acute suicide
* have psychotic symptoms and need to use antipsychotic drugs
* receive ECT treatment within 2 months
* pregnant, breastfeeding or planning to become pregnant during the trial
* refuses to sign the consent
Difficulties and Obstacles to the Integration in Community of Children With Type 1 Diabetes Before Primary School.

The incidence of type 1 diabetes is increasing worldwide and in France, including among young children.

Type 1 diabetes has consequences for integration in community, especially on the management of hypoglycemia and hyperglycemia, mealtimes, participation in sporting activities and school trips.

This works' purpose is to describe obstacles and difficulties to the integration in community before primary school (day care center, childminder, and nursery school) of a complete sample of children with type 1 diabetes followed in the Diabetology Department of Lyon Pediatric Hospital, at the start of the school year 2018-2019. The investigating team will carry out a descriptive study, using different questionnaires addressed to the professionals (nursery school directors, day care nursery directors, childminders, school doctors, pediatricians and doctors of child and maternal protection centers) and to the parents of children with type 1 diabetes. These different questionnaires will help to take into account different points of view, in order to identify all the obstacles to integration of children with type 1 diabetes in community.

Through this work, secondary information actions through training and/or information leaflets will be carried out in order to facilitate the reception of these children in the community.


Eligibility Criteria:
Inclusion Criteria:

Children:

* Type 1 Diabetes
* Followed in the diabetology department of Lyon pediatric hospital
* Who are too young to go to primary school in 2018-2019
* Residing in the Rhône-Alpes region of France
* No parental opposition to the completion of the questionnaire (reflection period of 15 days after receipt the leaflet information)

For school directors, school doctors, pediatricians, child and maternal protection center doctors

* Questionnaire responses will be considered as evidence of no opposition.

Directors of nurseries and childminders who will agree to answer the telephone questionnaire after parents allow the study team to contact them

Exclusion Criteria:

Children:

* Child requiring another facilities for school (food allergies, celiac disease...)
* Language barrier not permitting a response to the questionnaires

For childminders and nursery directors

* refusal of parents to contact them
* refusal to participate declared during the telephone interview

For school directors, doctors and school doctors

* No prior involvement in the reception in community of a type 1 diabetes child
Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers

Background: Taking alginate impressions for preschoolers is challenging and might be disturbing for them. Therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression.

Objectives: The present study aims to evaluate and compare the level of patients' discomfort, dental anxiety, gag reflex, behavior and time required for taking alginate impressions with that of intraoral scanning.

Materials and methods: The study will be a randomized, controlled clinical trial, parallel design. A total of 666 pediatric dental patients aged from 4-6 years will be selected from the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University. Participants will be allocated into 2 groups. Children in the first group will receive digital impressions by an intraoral scanner, while those of the second group will receive conventional alginate impressions. Patients' discomfort will be evaluated by a modified VAS index supported with emojis. Dental anxiety will be evaluated using Facial Image Scale (FIS). Gag reflex will be assessed by Gag Severity Index (GSI). Child's behavior towards the impression technique in the 2 groups will be evaluated using Venham's Behavior rating scale. Time taken to complete the procedures will be recorded using a digital stopwatch.


Eligibility Criteria:
Inclusion Criteria:

* Children with scores of 3 or 4 during preoperative assessments according to the Frankl Behavioral Rating Scale.
* No previous dental experience.
* Patient's parents signed an informed consent before participating in the trial.

Exclusion Criteria:

* Any physical or mental disability, or psychological problems.
* Children with temporomandibular joint or periodontal discomfort
A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)

A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Female subject is not pregnant or lactating, Females of childbearing potential must use reliable means of contraception during the course of the study
* Subject is in good health
* Subject is able to abstain from smoking during the 24-hour periods before and during each treatment day

Exclusion Criteria:

* Subject has a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI surgery
* Subject has a history of asthma or severe allergies to drugs or foods
* Subject currently uses prescribed or nonprescribed drugs on a regular basis
* Subject has a recent history of drug/alcohol abuse
* Subject consumes more than 6 cups of coffee per day
* Subject has unconventional or extreme dietary habits
* Subject has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
* Subject has a history of allergy or intolerance to antacids
* Female subject is known to be pregnant or is not using reliable means of contraception
Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions

* Primary Objective: to evaluate the interaction with food after a single oral dose of a fixed combination of amodiaquine (AQ) and artesunate (AS) (COARSUCAM™) in healthy male subjects
* Secondary Objective: to assess the clinical and biological safety and tolerability of Coarsucam™


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian subjects
* Weight between 50 kg and 90 kg. 18 ≤ Body Mass Index ≤ 28 kg/m2.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Mylan Insulin Aspart Study

The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy profile between MYL-1601D and NovoLog® in patients with T1DM.

This is a multicenter, open-label, randomized, parallel-group phase 3 study in subjects with T1DM comparing the safety and efficacy of MYL-1601D with NovoLog®.

After up to 3-week screening period, all subjects will be titrated on NovoLog® during a 4-week run-in period, and will be shifted from their current basal insulin to study insulin Lantus®. After run-in period, subjects will be randomized; one group will receive MYL-1601D, while the other group will receive NovoLog® for 24 weeks. A follow-up visit, via telephone call, will be scheduled 4 weeks after last dose of MYL-1601D.

Eligibility Criteria:
Inclusion criteria

1. Written and signed informed consent.
2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.
3. Subject is able and willing to comply with the requirements of the study protocol.

Exclusion Criteria

1. History or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk from study participation.
2. History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, OR history of significant allergic drug reactions.
3. Any clinically significant abnormality in electrocardiogram or safety laboratory tests.
4. Any elective surgery requiring hospitalization planned during the study period.
5. History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.
6. Subjects with major depressive illness in the last 3 years.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery

Preterm birth is a leading cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die every year due to the complications of preterm birth and rates are on the rise. Of the 14 million survivors per year, most face a lifetime of disability, including learning disabilities, visual and hearing impairments. The majority of preterm birth happen spontaneously (SPTD) which is often a multi factorial event, precocious cervical softening, shortening and dilatation are a common underlying factor. In the scope of this project the investigators propose to develop and clinically validate a new device, Cervix Monitor (CM), for detecting cervix conditions leading to SPTD and its risk assessment.

SPTD is closely related to a premature cervical ripening. The scientific basis for the proposed project is that the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervical tissue is collagen. Cervical ripening is the result of realignment of collagen, degradation of collagen cross-linking due to proteolytic enzymes. These processes affect the elasticity modulus of the cervical tissue. Therefore, assessment of cervix by a device (CM) measuring cervical elasticity (stiffness) and cervical length (effacement) appears to be an adequate approach for identifying pregnant women at high risk of SPTD. The CM is based on measuring applied pressure to the cervix by a tactile sensor array (stress data) and ultrasound measurement of cervix length (strain data). Tactile and ultrasound sensors are allocated on the tip of the measuring part of vaginal probe. The discovery of novel bio markers that could reliably identify women who will subsequently deliver preterm, may allow for timely medical intervention and targeted therapeutic treatments aimed at improving maternal and fetal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age from 24 to 28 weeks at time of Cervix Monitor measurement
* Singleton in the current pregnancy

Exclusion Criteria:

* Fatal anomaly
* History of fetal reduction in the current pregnancy to the singleton gestation
* Preterm rapture of membranes
* Current or planned cervical cerclage
* Planned indicated preterm delivery
* Active known cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
* Ischemic heart disease and or arrhythmia
* Active skin infection or ulceration within the vaginal/vulva (Herpes infection)
Ibuprofen Use on Post-operative Pain Following Cholecystectomy

In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen.

Ibuprofen is a widely used NSAID that has antipyretic, analgesic, and anti-inflammatory effects. In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy.The participants in this study were randomized into two groups. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen. The investigators recorded demographic data including gender, age, ASA, BMI, duration of anesthesia and surgery, poNV, LOS, VAS scores and opioid consumption postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* ASA grade I-II patients
* Aged 18-65 years

Exclusion Criteria:

* History of allergies or hypersensitivity to the aforementioned agents
* Renal, hepatic or gastrointestinal disease
* Significant cognitive impairment
* Recent use of long-term nonsteroid anti-inflammatory and opioids
* Oral anticoagulant use or known bleeding disorders
* Diabetes or any other neuropathic diseases
* Pregnancy or breastfeeding
Seizure Detection and Warning System in Epilepsy Patients

This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.

The Brain Sentinel™ Seizure Detection and Warning System is intended for monitoring children and adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring (night time or any other time of day) of individuals due to their history or risk of generalized tonic-clonic seizures. The device will withstand activities of daily living including showers and sleep.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
2. Male or female between the ages of 2-99.
3. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
4. Be able to tolerate wearing the device on the upper arm.
5. If female and of childbearing potential, has a negative pregnancy test.
6. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
7. Subject and/or Primary Caregiver must be competent to follow all study procedures.
8. Is able to read, speak and understand English.

Exclusion Criteria:

1. Does not have a documented history of generalized seizures.
2. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm)
3. Pregnant female
4. Subject/Caregiver is unable to provide consent.
5. Subject/Caregiver is not competent to follow home study procedures.
6. The subject is homeless or in a home without a power supply.
Bivalirudin vs Heparin in ECMO Patients

This is an open label, randomized study comparing the clinical outcomes of unfractionated Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.

This open label randomized study will compare the clinical outcomes of patients on ECMO who are anticoagulated with Heparin and Bivalirudin. Patients will be anticoagulated with a heparin bolus at the commencement of ECMO per standard of care, as there will be insufficient time to randomize these frequently emergent patients. Consent for the study will be obtained from a legally authorized representative Prior to starting a continuous infusion of maintenance anticoagulation, patients will be randomized to bivalirudin or heparin. Outcome measures are bleeding, thrombosis, development of Heparin Induced thrombocytopenia, number of cross-overs between the two research arms, circuit failures, decannulation, deaths and discharges from hospital.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients on veno-arterial (VA) or veno-venous (VV)ECMO

Exclusion Criteria:

* Patient or surrogate decision makers cannot provide informed consent.
* Patients who have intolerance to either heparin or bivalirudin
* Patients who received any form of thrombolytic therapy within the past 30 days.
Shortening Compression Time After Radial Access for Cardiac Catheterisation

To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary intervention (PCI) the cardiologist can choose between the femoral artery and the radial artery. In the University Medical Center Groningen the femoral artery is commonly used. After intervention the puncture site is closed with an arteriotomy closure device (ACD). Patients after radial access receive a pressure bandage at the puncture site, usually the Terumo (TR) wrist bandage.

The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1 hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding complications after the procedure. In patients with radial access, the TR bandage will be removed according to current protocol after 4 hours and additionally 1 hour observation is required. Several cardiologists have the intention to use the radial artery more frequent for cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73% decrease in major bleeding complications compared to femoral access. Also there are no significant differences in MACE. Even so there are no differences in success percentage for cardiac catheterization or PCI and admission time is shorter for radial access (Am Heart J. 2009 Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the short-stay unit is in case of femoral access with an ACD approximately 2 hours. For patients after radial access post procedural admission time is approximately 5 hours. To guarantee patient throughput, uniformity of care and more efficient use of capacity of the short-stay unit, patients after radial access should not have a longer hospital admission time than patients after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5) have shown that it is safe to deflate the TR wrist band faster than four hours.

Objective of the study:

To describe the differences in safety, patient comfort and admission period after diagnostic cardiac catheterization through radial access, between the current protocol and the protocol of fast desufflation by Carrington et al.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic coronary angiogram
* Radial access
* 6 French sheath

Exclusion Criteria:

* Use of oral anticoagulants
* Percutaneous coronary intervention
New Hemolysis Parameters in Sickle Cell Disease

The 6-minute walk (6MWT) test is used in adults and children affected by a wide range of chronic diseases to evaluate their sub-maximal exercise capacity. It reflects the global response of various physiological systems (respiratory, cardio-vascular, neurologic, metabolic and musculosquelettic) in a situation simulating a daily life activity. In children with sickle cell disease, the 6MWT is correlated with a low level of hemoglobin, a low level of fetal hemoglobin and low red cell deformability. Our team previously reported that in a population of children with sickle cell disease, highly treated with hydroxyurea, the sole factor which was independently linked to the 6MWT was the presence of silence infarct.

As the cardio-vascular and cerebro-vascular injury in sickle cell disease are directly correlated with hemolysis, the investigators aim to evaluate a) the clinical relevance of endothelial and inflammation parameters and new hemolysis markers and b) if the presence of silent infarct and the 6MWT are correlated with this biological markers.

This cross-sectional study will include sickle cell disease patients regularly followed for more than 5 years at Hôpital Universitaire des Enfants Reine Fabiola, Centre Hospitalier Universitaire (CHU)-Brugmann, Centre Hospitalier Etterbeek-Ixelles, CHU Saint-Pierre, Cliniques Universitaires Saint-Luc (Bruxelles, Belgium). Inclusion criteria are: sickle cell disease (SS, Sbeta°, SC, Sbeta+), age range : 6 to 25 years, signed informed consent. Exclusion criteria are: transplanted patients, inability to perform the 6MWT (severe cognitive disability, femoral osteonecrosis with functional impairment), hospitalization and/ or transfusion in the last 3 months for acute event.

Demographic data and clinical data will be retrospectively recorded. Blood test and 6MWT will be performed in steady state. Studied analysis will be: coagulation factors, free hemoglobin, Pro-B type natriuretic peptide (Pro-BNP), High sensitivity C reactive protein (HS-CRP), Intercellular Adhesion Molecule (ICAM), Vascular Cell Adhesion Molecule (VCAM) and Selectins.

With this study, the investigators expect to validate new predictive markers for cardio-vascular or cerebrovascular injury and to identify patients at high risk to develop these complications.


Eligibility Criteria:
Inclusion Criteria:

* Sickle Cell Disease (HbSS, S beta°, S beta+, SC)
* Regular follow-up from more than 5 years
* Written informed consent

Exclusion Criteria:

* Transplanted patients
* Hospitalisation for an acute event within 3 months
* Acute transfusion within 3 months
* Unable to performed 6-minute walk test
Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms

Actually, there are few data about the effectiveness of remote monitoring (RM) and patient centered alarms setting in patients with unexplained syncope underwent implanted loop recorder (ILR) monitoring.

The aim of this study is to evaluate the time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.


Eligibility Criteria:
Inclusion Criteria

* Patients with unexplained syncope underwent ICM implantation according to current gudelines.

Exclusion Criteria

* Patients do not provied signing Patient Informed Consent Form