cyrilzakka/clinical-trials huggingface dataset:
Effect of Hypnotherapy and Educational Intervention in Irritable Bowel Syndrome

Aim: Gut directed hypnotherapy can reduce IBS symptoms but the mechanisms underlying this therapeutic effect remain unknown. We determined the effect of hypnotherapy and educational intervention on brain responses to cued rectal distensions in IBS patients. Methods: 44 women with moderate to severe IBS and 20 healthy controls (HCs) were included.. Blood oxygen level dependent (BOLD) signals were measured by functional Magnetic Resonance Imaging (fMRI) during expectation and delivery of high (45 mmHg) and low (15 mmHg) intensity rectal distensions. Twenty-five patients were assigned to hypnotherapy (HYP) and 16 to educational intervention (EDU). 31 patients completed the treatments and the post treatment fMRI. Results: Similar symptom reduction was achieved in both groups. HYP responders demonstrated a pre-post treatment BOLD attenuation in both anterior and posterior insula during high intensity distension, while EDU responders had a BOLD attenuation in prefrontal cortex. Pre-post differences for the low distension and for the two expectation conditions were almost exclusively seen in the HYP group. For all responders there was a significant correlation between treatment induced reduction of GI related anxiety and BOLD decrease in the anterior insula. Following treatment, the brain response to distension was similar to that observed in HCs, suggesting that the treatment had a normalizing effect on the central processing abnormality of visceral signals in IBS. Conclusions: The abnormal processing and enhanced perception of visceral stimuli in IBS can be normalized by psychological interventions. Symptom improvement in the treatment groups may be mediated by different brain mechanisms.


Eligibility Criteria:
Inclusion Criteria:

Rome III Female Age 20-60 Swedish speaking Right-handed

Exclusion Criteria:

Central acting medication IBD Psychiatric diseases Abdominal surgery NictoinePacemaker Prosthesis Metal in the brain Claustrophobia Large tattoo

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Robot-assisted and Connected 6-minute Walk Test (TM6)

Evaluation of the reliability of the PEPPER robot in assisting and recording the parameters of a TM6. Patients referred to the EFRED service for the performance of a 6MWT will be assisted during their test by the PEPPER robot. The PEPPER robot will also collect the parameters of the 6MWT and produce a report. The EFRED service technician will remain present during the 6MWT and will take note of the test parameters. An evaluation of patient satisfaction with the assistance of the Robot Pepper in the realization of the 6MWT will also be carried out.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Speak fluent French.

Exclusion Criteria:

* Patient's refusal to participate in the study
* Language barrier
* Cognitive disorders.
Cancer and Literacy in Health

Validation in French of a psychometric tool for measuring health literacy in the field of cancer

Single-centre, non-interventional questionnaire study

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older, having been informed of the research
* Followed or having been followed at the Hôpital privé des Peupliers for a cancer

Exclusion Criteria:

* Patient who has indicated his/her opposition to the use of his/her medical data
* Patient under legal protection, guardianship or curatorship
Comparative Study Between Tonometers

Comparative study between the Goldmann Flattening Tonometer and the Non-Contact Tonometer in patients of a Reference Ophthalmological Hospital


Eligibility Criteria:
Inclusion Criteria:Pacients with glaucoma diagnosed -

Exclusion Criteria:Pacients without glaucoma diagnosed

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C-Pulse® System European Multicenter Study

The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System in the usual manner and according to the approved indications and contraindications.

Evaluation of the post-market clinical performance and safety of the C-Pulse® System for the treatment of Heart Failure in the population of patients who meet the approved clinical conditions provided in the indications and contraindications.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years or older
* Patients with moderate to severe ambulatory heart failure \[American College of Cardiology/American Heart Association (ACC/AHA) Stage C; NYHA Class III/IV ambulatory\], who are refractory to optimal medical therapy
* Patients who are non-responders to CRT pacemaker therapy
* Patient has signed and dated the investigation informed consent form

Exclusion Criteria:

* Evidence of significant ascending aortic calcification on postero-anterior chest X-ray or CT scan
* Moderate or severe atherosclerotic aortic disease
* Ascending aorto-coronary artery bypass grafts
* Any history of aortic dissection
* Connective tissue disorder such as Marfans disease
* Aorta not conforming to specified dimensional constraints
* Patient has severe mitral valve incompetence, grade 4+
* Patient has moderate to severe aortic valve incompetence, grade 2 - 4+
* Patient has systolic blood pressure less than 90 or greater than 140mmHg
* Presence of active systemic infection
* Presence of bleeding or coagulation disorder (relative)
Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation. A Prospective Observational Study.

Endotracheal intubation is a frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital) but optimal Macintosh blade size remains unknown to date.

Endotracheal intubation is an extremely frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital). Apart from special cases of foreseen difficult programmed intubation, direct laryngoscopy remains the most frequently used technique. It requires the use of a handle (short or long), which serves as a light source on which is adapted a Macintosh curved blade, metallic or plastic, single or multiple use. The choice of blade size is based on the experience of the physician. Most often, in adult settings, size 3 or 4 blades are used. The very spartan literature on the subject and the current recommendations do not provide any information on the choice of blade size. We therefore wish to evaluate these practices in terms of success of the first laryngoscopy, Cormack-Lehane and POGO (percentage of glottic opening visualized) scores, the need to use an alternative technique or a second operator. The results will be analyzed with regard as a function and experience of the person performing the laryngoscopy, as well as the setting (urgent or scheduled). These data are usually collected during the performance of an endotracheal intubation whatever the circumstances: operating room, intensive care unit and emergency department (in-hospital) and in the SAMU-SMUR (pre-hospiatl medical service) at Clermont-Ferrand University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be admitted in an operative room, an intensive care unit (ICU) or an emergency department and require mechanical ventilation through an orotracheal tube.
* Adult (age ≥ 18 years)
* Subjects must be covered by public health insurance
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria:

* Anticipated difficult intubation requiring videolaryngoscopy
* Nasotracheal intubation
* Refusal of study participation or to pursue the study by the patient
* Absence of coverage by the French statutory healthcare insurance system
* Protected person
A Dose-optimization Study of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) Disease

The main purpose of this study is to evaluate differences in the pharmacodynamic response of 4 Aldurazyme® (laronidase) dose regimens in patients with Mucopolysaccharidosis I (MPS I).


Eligibility Criteria:
Inclusion Criteria:

* Have a documented diagnosis of MPS I, confirmed by measurable clinical signs and symptoms of MPS I, and a documented fibroblast or leukocyte α-L-iduronidase enzyme activity level of less than 10% of the lower limit of the normal range of the measuring laboratory.
* Weigh at least 12.5 kg.
* Have serum creatinine and blood urea nitrogen (BUN) values within age appropriate normal ranges.
* Provide signed, written informed consent prior to any protocol-related procedures being performed. Consent of a legally authorized guardian(s) is (are) required for patients under 18 years. If the patient is under 18 years old and can understand the consent, written informed consent will be required from both the patient and the authorized guardian(s).

Exclusion Criteria:

* Have previously received Aldurazyme® (laronidase).
* Have a suspected hypersensitivity to Aldurazyme® (laronidase) or known hypersensitivity to components of the infusion solution.
* Have previously undergone hematopoietic stem cell transplantation (HSCT; i.e., from bone marrow \[BMT\], peripheral blood, or umbilical cord blood) or other major organ transplantation.
* Have a medical condition, serious inter-current illness, or other extenuating circumstance that may interfere with study compliance including all prescribed evaluations and follow-up activities, except the 6MWT. (Note: All patients may not be capable of performing the 6MWT due to age and/or maturity level. Exemption from performing the 6MWT must be obtained in writing by the investigator from the sponsor's medical monitor prior to enrollment).
* Have an acute illness that requires surgical intervention, and/or anticipates surgery during study participation, and/or has had surgery within 30 days prior to study enrollment.
* Have received an investigational drug within 30 days prior to study enrollment.
* Is pregnant or lactating. Female patients of childbearing potential must have a negative pregnancy test \[urine β-human chronic gonadotropin (hCG)\] at entry (prior to the first infusion). Note: All female patients of childbearing potential and sexually mature males must be advised to use a medically accepted method of contraception throughout the study.
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury

The purpose of this study is to determine single dose pharmacokinetics of daptomycin consecutively in 10 patients on three different time points after severe burn injury.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of 18 years or older
* Second and/or third degree thermal injury
* Total body surface area burned ≥ 15%
* Hospitalisation in the ICU for burn injured patients of the University Hospital Zürich
* Probability of ICU stay of \>14 days
* Written informed consent by the patient or in patients unable to be informed or to sign according to section 4.4 of the study protocol

Exclusion Criteria:

* Evidence of renal failure (Creatinine clearance \<30ml/min) or continuous renal replacement therapy such as continuous hemofiltration
* History of muscle disease or skeletal muscle disorder
* Creatine-phosphokinase (CPK) ≥ 5 times the upper limit of normal (ULN)
* History of hypersensitivity to the drug
* Pregnancy
* Severe coagulation disorder
The Relationship Between the Residual Renal Function and Osteoporosis Treatment

The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we plan to reveal relationship between osteoporosis drugs and kidney damage.

Chronic kidney disease (CKD)- mineral and bone disorder (CKD-MBD) is one of the topic in osteoporosis treatment. As many osteoporotic patients are older, many patients are under the deterioration of the renal function. In addition, several drugs might have the potential for kidney damage. But the relationship between osteoporosis drugs and kidney damage is unclear.

The main objective of this study is to reveal relationship between osteoporosis drugs and kidney damage.

Eligibility Criteria:
Inclusion Criteria:

* Osteoporosis patients

Exclusion Criteria:

* eGFR \< 15
Intelligence Quotient Assessment in Children With Autistic Spectrum Disorders.

The aim of this study is to assess the cognitive strengths and weaknesses of children with autism and the possible effect of age and IQ on Stanford-Binet Intelligence Scale, 5th Edition. Such analysis will help us for prompt and early intervention.

Autism Spectrum Disorders (ASDs) are characterized by deficits in both social interaction and communication, as well as by restricted and repetitive patterns of behavior, and are a type of Pervasive Developmental Disorder (PDD). Intellectual disability (ID) is characterized by deficits in adaptive functioning, an intelligence quotient (IQ) that falls at least two standard deviations below average (i.e., below 70), and onset prior to adulthood (American Psychiatric Association, 2000).

Although ID is not a core symptom of ASD, there is an established relationship between the two constructs. Seventy percent of children with AD have a co-morbid diagnosis of ID (Bolte \& Poustka, 2002; Fombonne, 2005). It has been suggested that many children who would have been diagnosed with ID in the past would today receive an ASD diagnosis, even with identical symptomatology (Lecavalier et al., in press).

The SB5 is a descendent of the very first intelligence measure ever created. It tests general intellectual ability, and the Fifth Edition affords the ability to report Full Scale, Abbreviated, Nonverbal, and Verbal IQ scores(Roid, 2003).. One of the updated features of the SB5 is the nonverbal component, in that close to half of the responses no longer require verbal answers (Coolican, Bryson \& Zwaigenbaum, 2008).The Full Scale IQ is derived from the verbal and nonverbal scales, each with five subtests bearing the same names: Fluid Reasoning, Knowledge, Quantitative Reasoning, Visual Spatial Processing, and Working Memory.

Eligibility Criteria:
Inclusion Criteria:

* Age: from3 to18 years
* Gender: both sexes will be included in the study
* Clinical ASD diagnosis.
* Full Scale test results available for SB5.

Exclusion Criteria:

* 1- Age below 3years or above 18 years. 2- Mental Retardation due to other causes than autism. 3- Presence of other chronic illnesses affecting their quality of lives.
Surgical Treatment of Type 2 Diabetes in Non-Morbidly Obese Patients

The aim of this study is to assess the short term success and feasibility of ileal transposition with sleeve gastrectomy in non-morbidly obese patients with poorly controlled Type 2 Diabetes Mellitus


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed Type 2 Diabetes for 3 to 5 years.
2. Poorly controlled blood sugar despite standard of care\* as demonstrated by HbA1c 8-11 for at least 6 months and 3 office visits. Standard of care is based on the ADA (American Diabetes Association) guidelines which include nutrition, exercise, education, behavior modification and pharmacological treatment. A co-investigator endocrinologist will ensure that the above standard of care has been met.
3. BMI between 25.0 and 34.4.
4. Stable weight as determined by no more than a 3% change in body weight in the last 3 months.
5. Age between 35 and 65 (both men and women will be included).
6. Able to provide Informed Consent.
7. Able to comply with follow-up procedures.

Exclusion Criteria:

1. Previous history of major abdominal surgery which may lead to a hostile abdomen.
2. Pregnancy
3. Patients who have an incurable malignant or debilitating disease
4. Serious uncorrectable impairment of coagulation (INR\>1.4, PTT \> + 3 secs), lungs, kidney or heart
5. Diagnosed severe eating disorder
6. Use of medication for weight loss in the last 6 months
7. Untreated endocrine disorder
8. Active peptic ulcer
9. Untreated H. pylori
10. Cognitive Impairment
11. Diabetic autonomic neuropathy
12. Symptomatic gastroparesis
Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)

The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a 6-month period.

SMART-AV is a randomized, multi-center, double-blinded, non-significant risk, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT-D therapy. Patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center. The study will compare chronic changes in structural and functional outcomes in CRT-D patients randomized to AV delay set as fixed, set with SmartDelay or determined by echocardiography. Patients will be followed at enrollment, implant, post-implant, 3-months post-implant and 6-months post-implant.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet current indications for a BSC CRT-D device with the SmartDelay algorithm
* Patients who are willing and capable of undergoing a device implant and participating in all testing associated with the SMART-AV Study
* Patients who are on optimal and stable pharmacologic therapy
* Patients who are expected to be in sinus rhythm at the time of implant
* Patients who have a life expectancy of more than 360 days, per physician's discretion
* Patients who are geographically stable and willing to comply with the required follow-up schedule
* Patients who are 18 years of age or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Patients who are in complete heart block, or who otherwise are unable to tolerate pacing at VVI-40 RV for up to 14 days
* Patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at VVI-40 RV for up to 14 days
* Patients who have previously received cardiac resynchronization therapy
* Patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study
* Patients who currently have or who are likely to receive a tricuspid valve prosthesis
* Patients who have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
* Patients who are pregnant or planning to become pregnant during the study
* Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty

This pilot cluster-randomized, two-arm parallel-group controlled trial, aims at enhancing the understanding of the effects of real-time feedback on functional deficits as knee valgus thrust, pelvic drop, and lateral trunk lean after total hip arthroplasty. Biomechanical and patient-reported outcomes will be assessed after a total hip arthroplasty as well as at three and six months follow-ups. The primary research question is, whether digital real-time feedback supported home-exercising improves the control of the frontal knee range of motion, pelvic obliquity, and lateral trunk lean, superior to exercising supported by written instructions as comparator. The secondary aspect focuses on potential differences between groups concerning aspects of quality of life, function, and physical activity. Tertiary functional outcomes between groups will be compared for reasons of quantification movement quality.


Eligibility Criteria:
Inclusion Criteria:

* age from 50-75 years
* body mass index from 18.5 to 29.99 kg/m²
* able to walk without walking aids at baseline assessment
* scheduled for elective unilateral total hip arthroplasty surgery
* willing to comply with all study related procedures and provide informed consent

Exclusion Criteria:

* symptoms of delayed healing concerning the implant
* cardio-respiratory symptoms limiting exercise therapy (for example severe heart disease)
* symptoms of musculoskeletal or cardio-respiratory overload
* neuro-motor diseases (for example previous Stroke, Multiple Sclerosis, Morbus Parkinson Disease)
* other reasons which would lead to obvious limitations concerning their participation in the intervention (for example severe contralateral osteoarthritis (OA), lower extremity fractures within previous 12 months, other elective lower extremity surgery within 6 months, inadequacy in German concerning questionnaires and exercise instructions, mentally unable to participate)
* non-adherence (see definition under "therapeutic adherence").
Screening for Atrial Fibrillation With Prolonged Continuous Single-lead ECG Devices in High-risk Patients

Atrial fibrillation(AF) can be asymptomatic and thus left unidentified in many people, but holds potential risk of lethal complications such as stroke and congestive heart failure. With different screening strategy, the screening result will be different. The longer the monitoring period is, the higher chances AF episodes can be identified, but with greater cost and lower compliance. Therefore, in this study, the investigators want to find the most cost-effective method for AF screening in high risk population with prolonged continuous single-lead ECG device.


Eligibility Criteria:
We created a score system as to predict AF risk.

1. Age ≥ 75: 2points Age between 65-74: 1point
2. Male: 1point
3. Stroke: Typical symptoms of acute stroke with multiple foci on imaging examination: 5points Typical symptoms of acute stroke with single or uncertain lesion on imaging: 3 points Imaging examination shows old cerebral infarction, transient ischemic attack(TIA), lacunar infarction with clear symptoms: 2points
4. Congestive heart failure: Ejection fraction(EF)≥50%, N terminal pro-brain natriuretic peptide(NT pro-BNP)\>1500 pg/mL: 1point EF 40-49%: 2points EF\<40%: 4points
5. Echocardiography: Mitral stenosis or regurgitation, aortic stenosis or regurgitation: moderate degree and above: 2points Left atrial anterior-posterior diameter: 40-49mm: 1point Left atrial anterior-posterior diameter: ≥50mm: 2points
6. Vascular disease: History of myocardial infarction, percutaneous coronary intervention(PCI) or coronary artery bypass graft(CABG): 2points Clear history of peripheral arterial obstruction: 3points
7. Hypertension: Blood pressure controlled: 1point Blood pressure uncontrolled(Systolic blood pressure\>160mmHg): 2points
8. Diabetic mellitus: Plasma glucose level controlled:1point Plasma glucose level uncontrolled(HBA1c\>7):2points i:Chronic kidney disease: estimated glomerular filtration rate(eGFR) 30-49: 1point eGFR \<30: 2points j:Sleep apnea syndrome: 1point k:Chronic obstructive pulmonary disease: 1point l:Thyroid disease: 1point

Inclusion Criteria:

* 1.Age between 18-85 2.Score ≥5points in the above scoring system 3.Volunteer to participate in the study

Exclusion Criteria:

* 1.Clear history of atrial flutter or atrial fibrillation 2.History of pacemaker implacement 3.Already on anticoagulation therapy 4.History of severe contact dermatitis 5.ECG recorded by our device unrecognizable 6.Patients with end-stage disease or at advanced stage of cancer with life expectancy less than 1 year