cyrilzakka/clinical-trials huggingface dataset:
Restoration of Beta Cell Function and Cardiovascular Parameters in Relation to Adipoinsular and Enteroinsular Axes After Gastric Bypass Surgery

Bariatric operations such as the gastric bypass procedure provide a unique in vivo model of improvement of pathological beta cell function. The presented double-centre study aims to comprehensively investigate different aspects of beta cell function in patients with type 2 diabetes (T2DM) with a wide range of disease duration after gastric bypass. In parallel, our project will address the aspects of changes in enteroinsular and adipoinsular axes as well as the early and late changes of other defined parameters after gastric bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* indication forbariatric surgery or non-bariatric abdominal surgery

Exclusion Criteria:

* Pregnancy
The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias

The aim of this work is to study the changes of key assays useful for the understanding of anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays, hemolysis markers.

The aim of this work is to study the changes of key assays useful for the understanding of anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays, hemolysis markers.

The patient selection criteria are:

* age \> or = 18 years
* No history of transfusion \> or = 2 years
* Anemia (any etiology known or assumed)
* Decision of red packed cells transfusion for the current episode
* Transfusion performed at BEAUJON Hospital
* Agreement of patient for the study

Number of subjects required: 100 patients

Study duration and duration of participation for each patient:

* duration of the study: 1 year
* for each patient the participation to the study began at baseline after the decision of transfusion and stopped at the second sample ie at least 72 hours after the transfusion of red blood cells.

The maximum contribution for one patient is 5 days.

Methodology: It is a prospective non interventional monocentric (BEAUJON Hospital) study. Two blood tests will be performed; one before transfusion and the other from 48 to 72 hours after red packed cells transfusion.

The following parameters will be measured before and after red packed cells transfusion:

Complete blood count (CBC) with reticulocyte count; complete iron status (ferritin, serum iron, transferrin, transferrin saturation), soluble transferrin receptor; serum and intraerythrocytic folate levels, vitamin B12; lactate dehydrogenase (LDH), bilirubin (total and free), haptoglobin, orosomucoid, direct coombs test; creatinine; CRP.

The aim of this work is to study the changes of key assays useful for the understanding of anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays, hemolysis markers.

Eligibility Criteria:
INCLUSION CRITERIA:

* Age \> or = 18 years
* No history of transfusion \> or = 2 years
* Anemia (any etiology known or assumed)
* Decision of red packed cells transfusion for the current episode
* Transfusion performed at BEAUJON Hospital
* Agreement of patient for the study

EXCLUSION CRITERIA:

* Patient who received between the 2 samples, a treatment which can modify the parameters evaluated (iron, vitamin)
Interest of Simulation as Part of the Procedure Tracheobronchial Aspiration

The aim of this study is to compare a control group (Practical Work Group) with a High fidelity Stimulation group about competences and reasoning clinic.

Health simulation is in full development on the national territory (France). The medical profession and nurses use this mode of learning in initial training to improve the students skills The report of Pr Granry allowed an inventory of the simulation in France with as Leitmotiv "never the first time for the patient". It has also put in place priorities for the coming years, one of which is to develop simulation in initial and in-service training. This learning technique is interesting according to several parameters. First,is the safety of care. A novice who has already practiced on a mannequin or in the context of the simulation will be able to better understand the situation of care in the clinical field. The quality of care is also improved by the practice of simulation including communication skills, psychomotor skills, respect for procedures and theoretical knowledge. This more or less faithful reproduction is all the more necessary as the duration of clinical placements is decreasing. Simulation is a way to mitigate this lack is allows a faithful immersion in the care environment. Despite all these positive points, physiotherapy is not yet very affected by the simulation as shown in the literature Gordon's review (2015). Initial training, continuing education has not to this day largely developed this teaching method . Some timid uses have taken place and for the most part in Anglo-Saxon countries with various modes of simulation. In France, certainly linked to the specificity of the profession, its implementation is delicate, even complicated. It remains anecdotal to this day.

Eligibility Criteria:
Inclusion Criteria:

* Learners: All second year students enrolled in initial training of the Institute of kinesitherapy of Toulouse during the year 2017-2018. In total 45 students.
* Patients :All adult patients with tracheotomy, and able to communicate. Patients hospitalized in the University Hospital de Toulouse

Exclusion Criteria:

* Learners: Students absent on the day of the reading of the procedures
* Patients:Adolescent patients, child patients, Patients with a communication deficit, Patients under respirators
Investigation of the Effects of Local Vibration Applied to Different Regions and Spinal Stabilization Exercises

The aim of this study is to investigate the effects of local vibration application applied to different regions on postural control in addition to spinal stabilization training in ataxic multiple sclerosis (MS) patients.

The study was planned as a single-blind, randomized controlled trial. The patients included in the study will be divided into 3 groups by the closed-envelope randomization method. Each treatment will be 8 weeks, 3 days a week. The control group will be given 40 minutes of lumbar spinal stabilization exercises. Paraspinal vibration group; In addition to 40 minutes of lumbar spinal stabilization exercises, LV will be applied to the paraspinal muscles for 10 minutes. LV application will be applied to the cervical paraspinal muscles for 5 minutes and to the lumbar paraspinal muscles for 5 minutes, bilaterally, sequentially. Gastrosoleus vibration group; In addition to 40 minutes of lumbar spinal stabilization exercises, LV will be applied to the gastrosoleus muscle complex for 10 minutes. LV application will be applied bilaterally, sequentially (5 minutes on the right and left). Assessments will be made by a blind assessor. In assessments; demographic information, Expanded Disability Status Scale (EDSS) /Extended Disability Status Scale (disease stage), International Cooperative Ataxia Rating Scale (ataxia severity), Berg Balance Scale (performance-based balance), Trunk Impairment Scale (trunk control), Neurocom Balance Master Static Posturography (limits of stability and postural sway), OptoGait (gait analysis), lumbopelvic muscle endurance tests will be used.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-50
* Having been diagnosed with MS by a neurologist
* EDSS score between 3-5
* EDSS pyramidal system score of 3 or less
* Not using corticosteroids and/or stopping at least 3 months before starting the study

Exclusion Criteria:

* Having a history of attacks in the last 3 months
* Having orthopedic or systemic problems
* Presence of peripheral vestibular complaints
* Participating in another exercise program in the last 6 months
* Being mentally affected (Mini-Mental Test Score \< 24)
* Severe spasticity (MAS\>3)
* Refusal to participate in the study
The Use of Bone-, Tooth- and Mucosa- Supported Stereolithographic Guides for Dental Implant Placement

Introduction:

The use stereolithographic (SLA) guides may provide significant benefits in simultaneous placement of multiple implants, especially in large edentulous areas lacking anatomic landmarks for surgical reference. Planning of the implant positions prior to surgery may shorten the duration of the surgery spent by exploring and determining the suitable implant location on the edentulous alveolar crest in the standard technique . Previous studies have demonstrated the use of many SLA guide in this manner, however; most were designed to be used as placed on the alveolar crest (bone-supported) following a flap exposure, and there was no depth-control of the osteotomy drills. Further advances in stereolithography allowed flapless surgeries to be performed via mucosa-supported guides (Rosenfeld, et al. 2006c, Tardieu, et al. 2007). The use of these guides eliminates not only the time required for incision and flap exposure but post-operative patient morbidity and discomfort may also be reduced, due to the non-invasive nature of the procedure. The aim of this study is to investigate the accuracy, surgical and post-operative complications and post-loading outcomes of implants placed by the conventional and aforementioned computer-aided methods.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patient with at leat one edentuşous jaw

Exclusion Criteria:

* Patients with at least one edentulous jaw with healthy systemic and oral status without severe alveolar bone athrophy, major alveolar hard and/or soft tissue deficiency, mouth opening restriction, heavy smoking (\> 10 /per day) and parafunctional habits were included in the study.
* All patients were initially evaluated for the suitability of an implant supported fixed prosthesis and any patients unsuitable for such prosthetic superstructure (i.e. severe hard and soft tissue athrophy, insufficient hygiene practice etc.) were excluded.
Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT)

The purpose of this study is to compare two diagnostic interventions to improve the way D-dimer blood testing (MDA D-dimer) is used to diagnose first time symptomatic deep vein thrombosis.

* Limiting use of D-dimer testing to outpatients with a Low or Moderate clinical pretest probability (C-PTP)for deep vein thrombosis AND using a D-dimer level of \< 1.0 µg FEU/mL to exclude deep vein thrombosis in those with a Low C-PTP, and a D-dimer level of \< 0.5 µg FEU/mL to exclude deep vein thrombosis in those with a Moderate C-PTP, is as safe and a more efficient way to diagnose DVT than:
* Performing D-dimer testing in all patients with suspected deep vein thrombosis with use of a single D-dimer value of \< 0.5 µg FEU/mL to exclude thrombosis (current practice).

All randomized patients, including those who are treated for deep vein thrombosis after initial testing, will be followed for a period of 3 months to monitor for signs and symptoms suggestive of deep vein thrombosis, pulmonary embolism, bleeds and death.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Presenting with symptoms compatible with clinically suspected deep vein thrombosis

Exclusion Criteria:

* Treatment with full dose anticoagulation for 24 hours or more.
* Other test for deep vein thrombosis already performed.
* Ongoing need for therapeutic anticoagulant therapy.
* Life expectancy less than 3 months.
* Absence of acute symptoms within 7 days of presentation.
* Presenting with symptoms of pulmonary embolism.
* Previous confirmed episode of deep vein thrombosis or pulmonary embolism.
* Current pregnancy.
* Geographic inaccessibility which precludes follow-up.
Exploration of the Transfer of Barium From Thermal Mud

It involves conducting a clinical study on a population of healthy volunteers (age between 18 and 30 years) without direct benefit for the subject to explore a transfer of barium in the blood and urine following applications of thermal mud. The main objective is to highlight an increase in serum barium level of at least twice.

The presence of barium in thermal clays was noted by the ARS (french administration) who interviewed the Directorate General of Health (DGS); the latter seized the National Academy of Medicine (June 2016) which reported in February 2017.

In this report it was stated that there was no argument in favor of toxic phenomena related to the presence of barium but that it was appropriate, in particular, to evaluate a possible passage of barium in the skin in subjects who are treated with thermal mud

* by observing, where appropriate, an increase in serum and urinary barium levels in the subjects concerned and
* by measuring a possible depletion of barium in the sludge used. The DGS validated the various recommendations of the Academy and asked, in January 2018, the National Council of Thermal Establishments (CNETH) to implement the recommendations of the Academy.

It will therefore be a prospective before-after interventional study, implementing 15 daily applications of 6 mud poultices made with a clay used as thermal clay and containing appreciable barium levels.

A surveillance will be put in place with the event of suspected event, the volunteer can then be seen by a doctor.

Eligibility Criteria:
Inclusion Criteria:

* volunteers, healthy (without known and / or treated disease)
* 18 to 30 years old,
* men and women, who can give their informed consent, presenting the elements of cutaneous and general tolerance of sludge applications
* patient affiliated to a social security scheme

Exclusion Criteria:

* subject who can not give informed consent
* pregnant woman ; woman of childbearing years not wishing to have contraception available for the duration of the trial
* subject to a legal protection measure or a judicial review, subject having a known allergy to a heavy metal, a BMI greater than 30
* a characterized contact eczema, an active dermatosis, an acute affection, a disorder of the cutaneous sensitivity, an intolerance to the heat
* heart, kidney or lung disease that may be decompensated with the use of hot products
* a progressive disease (inflammatory, infectious or tumoral) potentially liable to worsen with the application of thermal physical agents
8% Sulphur-Aloe Vera Soap as an Adjuvant Treatment for Pityriasis Versicolor

Pityriasis versicolor (PV) is a superficial, mild, often chronic recurring infection of the skin caused by Malassezia species which is characterized by the formation of hypopigmented, hyperpigmented and/or erythematous macules. It commonly occurs on the trunk and proximal extremities, but can also be found on the entire body. Diagnosis of PV established based on clinical features and microscopic examination with potassium hydroxide. The goals of PV treatment are: to eradicate the hyphae, disappearance of clinical signs and symptoms, to lessen recurrences, and improve patient's quality of life. Topical antifungal remains first line therapy and search for an ideal topical agent of PV continue. Various studies reported combining more than one topical agents can increase the efficacy, thus result in faster mycological cure.

Pityriasis versicolor commonly has extensive and irregular pattern/distribution on the body. Therefore, topical antifungal such as ketoconazole, usually given in shampoo or solution form to cover large surface area. Many studies reported adverse effects of ketoconazole shampoo including pruritus, dry skin, and allergic contact dermatitis. Non-spesific keratolytic agent, such as sulphur, used for PV work by desquamation of the entire superficial skin layer and eliminating the fungi in the process. It also could enhance the penetration of ketoconazole into the stratum corneum, increasing its potency. Aloe vera (A. vera) contains acetylated mannan that acts as humectant and increase water content in stratum corneum. The combination of sulphur and A. vera in form of a soap as adjuvant to ketoconazole shampoo potentially will result in synergistic effect, faster mycological cure, and less adverse effects. There are limited data of sulphur and A.vera soap as an adjuvant PV treatment to ketoconazole shampoo. As a result of limited data, our trial is looked forward to assess the efficacy and adverse effect of sulphur and A.vera soap as an adjuvant PV treatment to ketoconazole shampoo.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age 18-65 years
3. Diagnosed as PV based on clinical features, microscopic examination using 10% potassium hydroxide, and Wood's lamp

Exclusion Criteria:

1. Pregnant or lactating women
2. PV with concurrent skin conditions (dermatitis or skin lesions in form of vesicles or blister or pustules or erosions or excoriation) with body surface area \>30%
3. Use of topical antifungal and/or corticosteroid 14 days prior to study entry
4. Use of systemic antifungal and/or corticosteroid 30 days prior to study entry
5. History of allergy to shampoo or soap containing ketoconazole, sodium lauryl sulphate, sulphur, A. vera, charcoal powder, glycerin, or perfume.
Early Breast Feeding and Glucose Levels in High Risk Newborns

Early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding. However, little data is available regarding its contribution to glucose levels in the newborn infants. Newborns that are at risk to develop hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum hypoglycemia.

Mothers will be encouraged to breast feed early after delivery (at the delivery room). Data of high risk babies for developing post partum hypoglycemia (Infants of diabetic mothers, infants of hypertensive mothers, infants with birth weight more than 4 Kg or less than 2.5 Kg and infants with meconium stained amniotic fluid)will be recorded including maternal breast feeding times and quality of feeding. Glucose levels shall be routinely monitored and recorded at the neonatal department. A comparison of all data will be made between those newborns that breast feed after labor and those who were not.

Eligibility Criteria:
Inclusion Criteria:

* Newborns to diabetic mothers
* Newborns to hypertensive mothers
* Newborns with birth weight greater than 4 Kg or less than 2.5 Kg
* Newborns with meconium stained amniotic fluid

Exclusion Criteria:

* Newborns with major congenital malformation
* Preterm babies
* Newborns with post-birth distress
REaCT-vascular Access Her2 Negative Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab

In the REaCT-Vascular Access Her2 negative study, the investigator will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent model" as part of a pragmatic clinical trial.

Determining the optimal vascular access strategy remains an important medical issue for patients, nurses, physicians and society. A novel method to allow comparison of established standards of care is needed as part of an increasing internationally mandated incentive to perform more pragmatic clinic trials.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary breast cancer
* Planned to start either FEC-D, AC-D, dose-dense AC-T, TAC, or TC chemotherapy, in the adjuvant or neoadjuvant setting.
* ≥19 years of age
* Able to provide verbal consent

Exclusion Criteria:

• Contraindication to central line placement.
Pilates to Treat Neck Pain

The neck pain comes from disturbances related to the cervical spine, of multifactorial origin and is considered a frequent problem of disability.

Pilates is a physical conditioning method that has been widely used to improve posture and develop body awareness.

The aim of this study is to assess the impact of the Pilates method in the control of pain, function and quality of life in patients with chronic mechanical neck pain.

Methods: 64 patients with chronic mechanical neck pain will be selected and randomized into two groups: intervention and control. Both groups will be assessed for pain, function, quality of life and medication intake.

The intervention group will hold Pilates sessions for three months, with two sessions per week. The control group will continue with the usual drug treatment. Both groups will be instructed to use 750mg acetaminophen every 6 hours if there is pain, but consumption of the drug will be controlled.

Although the symptoms of neck pain are common in the population, no study has investigated the effects of the Pilates method as a possible treatment for neck pain. The hypothesis is that the Pilates method can offer benefits to these patients.


Eligibility Criteria:
Inclusion Criteria:

* People with diagnosis of chronic mechanical neck pain and symptoms of pain in the lower region of spine, between the occipital and the first thoracic vertebra, for more than three months.
* Pain between 3 and 8 on the numerical pain scale
* Age between 18 and 65
* Both genders
* Agree to take part in the study and sign the terms of agreement

Exclusion Criteria:

* Fibromyalgia
* Previous traumatic injuries in the spine
* Infections and inflammation in the spine cervical pain radiating to upper limbs
* The practice of physical activity started or altered in the last 3 months
* Visual deficiency not corrected by glasses, disturbance in the central nervous system, hearing deficiency making the use of the method impossible.
Evaluation of Pressure Applying Efficiency in Multi-Layer Bandaging

Lymphedema is a condition characterized by excess accumulation of protein rich tissue fluid in interstitial spaces. It is a progressive chronic disease and without appropriate management may result in serious complications. In Israel, patients are referred to physiotherapists certified in treatment for lymphedema. According to the International Society of Lymphology (ISL) the best treatment is a holistic, multidiscipline approach. Amongst the different methods of lymphedema management, the use of compression is the only treatment that has shown to be effective in randomized controlled trials.

The ISL recommends that patients with lymphedema in the lower limb ought to bandage their leg with multi-layer bandaging on a daily basis for a period of two to four weeks. A new classification system for compression bandages was recommended; pressure of \<20 mmHg was categorized as mild, 20-40 mmHg as medium, 40-60 mmHg as strong and ≥60 mmHg as very strong. In patients with leg edema, bandages with strong pressure were shown to be the most effective. However, in the presence of a venous ulcer on a lymphatic leg, pressure between 35 and 45 mmHg is the widely accepted range for sufficient and safe compression. The use of measurement instruments is currently the only realistic method for determining the actual pressure achieved beneath the bandage. However, it is neither economical nor feasib¬le nor is it realistic in terms of time.

Recent studies show that many healthcare professionals use inadequate sub-bandage pressure. No study so far has focused on therapists that are trained in lymphatic treatment. In spite of correct pressure bandaging importance, the question whether physiotherapists succeed in correctly applying it is left unanswered. The main purpose of this study is to evaluate the pressure applying efficiency in multi-layer bandaging among physiotherapists in Israel who treat lymphedema.

34 physiotherapists trained in lymphatic treatment will be recruited for this research. Each volunteer will receive a questionnaire concerning their self-perceived competence in the application of compression bandages. Afterwards, two practical trials will be held a week apart in which the subjects will be asked to apply bandages using strong and medium pressure. Using PicoPress®, pressure will be measured directly after bandaging and two hours later. Our hypothesis is that the majority of therapists will properly apply medium or strong pressure on the lower limbs.


Eligibility Criteria:
Inclusion Criteria:

* Physical Therapists trained in Lymphatic treatments

Exclusion Criteria:

* Have not treated a Lymphatic patient in the past two years