cyrilzakka/clinical-trials huggingface dataset:
Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry

Therapeutic alliance, and drug observance are major difficulties in the care of persons presenting schizophrenic symptomatology. They appear to be linked to insight, the consciousness that one has of his troubles. Nurse care in psychiatry aims at improving it, but usually without using specific evaluation tool. Insight is usually not evaluated during care, and its evolution is also not known, although it is highly probable that a positive evolution of insight for a person in hospital correlated to an adapted and optimal care by the medical and nursing teams. The investigators do not know examples of insight evaluation during a sequence of hospital care, or any evidence of insight variation in relation to evolution abilities of some schizophrenic patients cared in hospital.

The investigators propose here to evaluate insight in people presenting schizophrenia or related troubles, at the beginning of hospitalization (I1) and 1 month later (I2), to better characterize insight variations, and identify the sociodemographic, clinical and therapeutic variables linked to it.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia,
* Persons requiring psychiatric care in one of the participating care unit
* I1 \< 6 (absent or bad consciousness of the trouble).

Exclusion Criteria:

* I1≥6
* Expression capacities incompatible with Q8 scale quotation (delirium, no understanding of the french language, mutism, contention or therapeutic isolation)
* Age under 18, absence of health care insurance
Efficacy Study of an Olfactory Stimulation Program for the Recuperation of Autobiographical Memories in Anorexia

The purpose of this study is to estimate the impact of an olfactive stimulation, in relaxing environment, on the access at the autobiographical memories in anorexic patients.


Eligibility Criteria:
Inclusion Criteria:

* Eating disorders, anorexia (restrictive form or mixed) according to DSM IV-TR ( Diagnostic and Statistical Manual of Mental Disorders IV - Text Revision) criteria
* Patient hospitalized in a department of one of the inquiring centers for a minimal duration of 5 weeks
* French language ability
* Coverage by the social insurance
* Fully informed patient who consent to participate in the study

Exclusion Criteria:

* Major mental associated disorders (psychotic disorders, bipolar disorder, major depression), neurological disorders or addiction to substances
* Psychotropic treatment (with the exception of antidepressants, anxiolytics and sleeping drugs, if the treatment was started more than 30 days ago)
* Any disorder susceptible to alter the reasoning capacities, discernment or judgment
* Physically or psychologically unable to answer questionnaires
The Engineer-Built System, Video-Game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children

There are 3 phases of this project. First phase is to study the satisfaction in healthy children aged 10-15 years old when they are playing our computer games. The sample size of this phase was 10. In addition, we will ask the occupational therapist to play and comment our game for further development.


Eligibility Criteria:
Inclusion Criteria:

* Normal children aged 10-15 years
* Sufficient cognitive/attention capacity
* Give the informed consent

Exclusion Criteria:

* Inability to understand the instruction and follow the task
* Has severe visual or auditory impairment
* Has limb deformities that interfere with video game playing
* Got an epilepsy or convulsive condition
* Denied to give the informed consent
The Effect of Roux-en-Y Gastric Bypass on Mitochondrial Function in Type 2 Diabetes

Roux-en-Y gastric bypass (RYGB) surgery induces resolution of type 2 diabetes, often within days after surgery and before significant weight loss. The aim of this study is to investigate whether changes in mitochondrial function contributes to the early improvement of type 2 diabetes after RYGB.

Mitochondrial dysfunction has been linked to development of insulin resistance in the muscle and hence to the pathogenesis of type 2 diabetes. Mitochondrial function can be studied non-invasively by 31 Phosphor Magnetic Resonance spectroscopy (31PMRS). In this study we will investigate changes in mitochondrial function using the combination of 31 PMRS and Near Infra-Red Spectroscopy (NIRS) after gastric bypass.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for gastric bypass surgery or cholecystectomy
* Verified type 2 diabetes or normal glucose tolerance by OGTT

Exclusion Criteria:

* Patients unable to fit the dimensions of the MRI-scanner
Prokinetic Drugs and Enteral Nutrition

The purpose of this study is to compare the effect of two drugs that can help in the prevention of regurgitation during the administration of enteral nutrition and define which one is the most effective.

Two prokinetic drugs (metoclopramide and erythromycin) will be compared during the administration of enteral nutrition in critically ill patients. We would like to know which one is the most effective in preventing regurgitation and risk of aspiration, which is a common complication of enteral nutritional support. This will be evaluated by measuring gastric residue every six hours.

Eligibility Criteria:
Inclusion Criteria:

* critically ill patients
* intubated
* mechanically ventilated
* 18 or older age
* enterally fed

Exclusion Criteria:

* prokinetic drugs before start study
* allergy to study medication
* interactions odf study medication with other drugs
* recent gastro-intestinal surgery
* history of esophagectomy or gastrectomy
* suspicion of gastrointestinal perforation
* myasthenia gravis
* liver dysfunction
* less than 7 days in study
* gastro- or jejunostomy
Glenosphere Size and Scapular Notch in RSA, Prospective Randomized Study

Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. The objective is to assess if eccentricity can avoid scapular notch as effectively as bigger glenospheres.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing reverse shoulder prosthesis because of rotator cuff disordes andacute fractures

Exclusion Criteria:

* patients with previous surgery
* patients with deltoid deficiency
* patients with acute infection
Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely

Utilization of nitric oxide (NO) therapy has been related to a trend towards short term improvement in very premature infants. A two year follow-up of children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. This study aims to evaluate follow-up at 6 years, in respiratory and neurodevelopmental outcome, of children born very prematurely, some of them having been treated with nitric oxide in the neonatal period.

Utilization of nitric oxide therapy in the neonatal period has been related to a trend towards short term improvements in respiratory and neurological outcome at 28 days postnatal age or 36 weeks postconceptional age. A two year follow-up in children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. No long term evaluation on respiratory outcome has yet been done. This study aims to evaluate respiratory and neurodevelopmental outcome at 6 years of age in children born very prematurely, some of them having had Nitric Oxide as a rescue treatment for respiratory distress syndrome.

Eligibility Criteria:
Inclusion Criteria:

* All infants included at birth in a randomized controlled trial using early nitric oxide therapy

Exclusion Criteria:

* Parental refusal
vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy

The feasibility and safety of laparoscopy are no longer to be demonstrated, especially in the field of gynecology, but this technique often causes post-operative pain. New techniques are being developed to overcome the inconvenience of laparoscopy, notably endoscopic transluminal surgery using a natural orifice (NOTES). It avoids incisions and therefore scarring, and could reduce post-operative pain. It is now developing in the field of transvaginal gynecology (vNOTES).

This study is the first prospective randomized study comparing the vNOTES technique to laparoscopy with postoperative pain assessment for performing a salpingectomy. The hypothesis is that the use of vNOTES transvaginal endoscopic surgery would reduce the post-operative pain of patients compared to laparoscopy in the context of a salpingectomy.


Eligibility Criteria:
Inclusion Criteria:

* planned surgery procedure : bilateral salpingectomy for outpatient benign indication
* patients with free, informed and signed consent

Exclusion Criteria:

* disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
* pregnancy or wish for subsequent pregnancy
* lactating women
* intervention in the context of pelvic cancer
* history of uni- or bilateral salpingectomy
* contraindication to laparoscopy
* history of rectal surgery
* endometriosis
* pelvic inflammatory disease
* genital infection
* not eligible for outpatient care
* associated surgical procedure planned during the intervention (hysterectomy, sub-urethral strip, prolapse cure ...)
* participation in another interventional research related to the gynecological sphere
* inability to understand the information given
* a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.
Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms

To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
* Be likely to complete the entire course of study and to comply with appropriate instructions

Exclusion Criteria:

* Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
* Have uncontrolled systemic disease
* Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
* Have anticipated contact lens wear during the study
* Have an active ocular infection
Brain Computer Interface for Communication in ICU: a Feasibility Study

The main objective of this study is to evaluate the usability of a system to assist verbal communication based on BCI system using the P300 wave in patients with tetraplegia who can no longer communicate because of severe engine damage (tetraplegia) and respiratory damage requiring invasive mechanical ventilation (intubation or tracheostomy) preventing verbal communication.


Eligibility Criteria:
Inclusion Criteria:

* Admitted in the ICU
* Quadriplegic and requiring mechanical ventilation (tracheostomy) 24/24h

Exclusion Criteria:

* Acute respiratory failure.
* Visual disorder
* Cognitive disorder
* Illiterate patient
* Mother tongue other than french
The Length of the Right Main Stem Bronchus as a Guide to Right-sided Double-lumen Tube Use

The Length of the Right Main Stem Bronchus Measured by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use

The double lumen tube (DLT) is the most popular way to isolate the lungs for thoracic surgery. The variable anatomy of the length of the right main stem bronchus seems to be the main reason clinicians are unwilling to use the right-sided DLT (R-DLT). The factors that could compromise the adequate ventilation of the right lung are mostly the variable length of the Right Main Stem Bronchus and the misalignment of the lateral orifice of the right-sided DLT in regard to the right upper lobe bronchus (RULB). The objectives of this study were to validate an alternative method to estimate the length of the Right Main Stem Bronchus by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing thoracic surgery

Exclusion Criteria:

1. Age\>70 or \<18 years
2. ASA classifications \>III
3. BMI \>35kg/m2
4. Modified Mallampati classification ≥III
5. Thoracic surgery within the last one month
6. Severe cardiopulmonary disease
Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves

Comparing the use of surgical robotics during a Cholecystectomy, comparing different platforms and approaches (multi port verses single port).

This study is a restrospective review of charts, including operating room notes as well as operating room documentation of procedures. Currently there are numerous methods considered to be the Standard of Care in the surgical treatment of Cholecystitis, or Cholelithiasis, including Open Surgery, Laparoscopic, and Robotic Assisted Laparoscopic Surgery. This study retrospectively reviews the intraoperative and post operative clinical outcomes of Laparoscopic and Robotic Assisted Surgery at U.C. Davis Medical Center to: 1) establish the role of robotics in laparoscopic surgery, and 2) to assess the learning curve by surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have undergone robotic assisted laparoscopic cholecystectomy

Exclusion Criteria:

* Patients under the age of 18, or not choosing to have surgery.
An Efficacy Trial of the MindFi App for Stress, Well-being, and Sleep Quality in Working Adults

90% of Asian workers report high levels of stress in an "always-on" culture. Stress and burnout are risk factors that account for 10-20% of health expenditure and threaten work longevity in the world's fastest growing economies. Traditional face-to-face sources of mental care such as counseling and psychotherapy are effective as a countermeasure to stress, but not always accessible or acceptable for those with busy lifestyles. Because of this, there is an urgent need for on-demand, scalable interventions to reduce stress and improve mental and physical well being. Technology-based solutions are increasingly being proposed to fill this need.

MindFi is a smartphone app that uses mindfulness exercises to help users cope with work stress and increase productivity. Since 2017, it has been featured by Apple, BBC, and Bloomberg and is being used at corporates such as Bain, Bloomberg, Cigna, and Zendesk. MindFi users contribute behavioral and self-report data, which are then used to generate individual recommendations for relevant, evidence-based exercises. These include mental care techniques such as mindfulness meditation, therapeutic journaling, psychosocial support and educational wellbeing quizzes.

In this study, the investigators will recruit 200 participants in a randomized controlled design, with 100 receiving access to content of the MindFi app, and 100 receiving access to a version containing music tracks for relaxation. Each intervention will last 4 weeks. Participants will use these apps for a period of 5 weeks (for a minimum of 10 minutes per day). Pre- and post-intervention, the investigators will measure self-reported ratings on a number of psychological variables, and will track sleep quality objectively for a one-week period.


Eligibility Criteria:
Inclusion Criteria:

1. Currently in full-time employment
2. Fluent in English
3. DASS-21 scores of at least 10 on the Stress subscale

Exclusion Criteria:

1. Current diagnosis of a chronic psychological disorder, or sleep disorder
2. Regularly practising meditation
MabionCD20 Compared to MabThera in Lymphoma Patients

The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20 (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell lymphoma.

Patients who meet criteria for participation in this study receive 8 intravenous infusions of MabionCD20® or MabThera® 21 days interval in combination with standard dosage regimen of CHOP. The duration of the study is 12 months. The treatment and observation period will last 26 weeks starting from Day 1, until Week 26 - one month after last IMP infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histological confirmed CD20 (cluster of differentiation 20) positive diffuse large B cell lymphoma (DLBCL)
2. Patients that had been diagnosed according to the WHO classification;
3. Performance status ≤ 2 on the ECOG (Eastern Cooperative Oncology Group) / WHO (world Health Organization) scale, performance status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated;

Exclusion Criteria:

1. Life expectance less than 6 months;
2. Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment;
3. Rituximab, other anti-CD20 mAb (Monoclonal Antibodies) drug treatment, treatment with any cell depleting therapies - e.g., anti-CD4 (cluster of differentiation 4) anti-CD5 (cluster of differentiation 5), anti-CD3 (cluster of differentiation 3), anti-CD19 (cluster of differentiation 19), anti CD11 (cluster of differentiation 11), anti-CD22 (cluster of differentiation 11), BLys/BAFF (B Lymphocyte Stimulator/B-cell activating factor) within 1,5 years before screening;
Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications

In which CHD patients with high risk of CV complications are different doses of LIPRIMAR used? For this purpose, data on hyperlipidemia will be elicited over and above the basic nosographic and demographic data, concomitant diseases and cardiovascular risk factor.


Eligibility Criteria:
Inclusion Criteria:

* Patients, who eligible to sign informed consent;
* Patients with indications to lipid lowing therapy, according to local product document.
* Patients with CHD and high risk of CV complications (Diabetes Mellitus II, Myocardial Infarction, Heart Failure, Arterial Hypertension, ets) will be included into study;
* Patients with LDL levels: \> 3,5 mmol/l

Exclusion Criteria:

* Individual intolerance of atorvastatin, in accordance to local product document.
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.

ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient perioperative atrial fibrillation and additional stroke factors after noncardiac surgery. The primary objective is to assess the effects of NOACs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. noncardiac surgery in the past 35 days with at least one of the following:

   1. an overnight hospital admission after surgery;
   2. day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator
2. ≥1 episode of clinically important perioperative AF during or after their surgery;
3. sinus rhythm at the time of randomization; AND
4. any of the following high-risk criteria:

   1. age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
   2. age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
   3. age ≥75 years.
5. provide written informed consent

Exclusion Criteria:

1. history of documented chronic AF prior to noncardiac surgery;
2. need for long-term systemic anticoagulation;
3. ongoing need for long-term dual antiplatelet treatment;
4. contraindication to oral anticoagulation;
5. severe renal insufficiency (CrCl \<20 ml/min);
6. severe liver cirrhosis (i.e., Child-Pugh Class C)
7. acute stroke in the past 14 days;
8. underwent cardiac surgery in the past 35 days;
9. history of nontraumatic intracranial, intraocular, or spinal bleeding;
10. hemorrhagic disorder or bleeding diathesis;
11. expected to be non-compliant with follow-up and/or study medications;
12. known life expectancy less than 1 year due to concomitant disease;
13. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
14. previously enrolled in the trial
Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives

The main objective of this study is to compare the rate of reported anxiety / depression (HADS \>= 8) among spouses and other family members in ICU patients.

The secondary objectives of this study are:

* to assess symptoms of anxiety (HADS ≥ 8) and depression (HADS ≥ 8) among relatives of ICU patients three months after discharge
* to assess what relatives felt vis-à-vis the information process
* describe the number and duration of interviews with participants
* to compare variables between the groups "spouses" and "other relatives".

  * satisfaction
  * number and duration of interviews
  * HADS questionnaire
  * The scale Edmunton
  * an internal questionnaire
  * IES-R score
  * level of mental well-being: WEMWBS
* to describe the completeness of the study
* to test the hypothesis that the development of symptoms related to physical manifestations of anxiety and depression predicts the development of post-traumatic stress at 3 months.
* to assess the impact of the various forms of stress during hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* The relative must have given his/her informed and signed consent
* The relative must be insured or beneficiary of a health insurance plan
* The relative must be available for 3 months of follow-up

Exclusion Criteria:

* The relative is under judicial protection, under tutorship or curatorship
* The relative refuses to sign the consent
* It is impossible to correctly inform the relative