cyrilzakka/clinical-trials huggingface dataset:
A Multistrain Probiotic in Patients With Irritable Bowel Syndrome With Predominant Constipation

Probiotics efficacy is mainly assessed by subjective endpoints such as the FDA responder rate or global relief, which partly explain contradictory results obtained in clinical trials with probiotic bacteria. Objective biomarkers of IBS will allow to measure the efficacy of probiotics. In the case of IBS-C, serum resolvin-D1 appears to be an interesting candidate due to its non-invasive and discriminating character compared to a healthy population. It is, inversely correlated with the severity of symptoms. Resolvin-D1 modulates the duration and intensity of inflammation by regulating the transcription of cytokines, chemokines and their receptors as well as other proteins involved in inflammation. Resolvin D1 could serve as a predictor of probiotic response based on its baseline value.

Resolvin D1 levels will be measured in patients with IBS-C as defined by the Rome IV criteria before 6 and 12 weeks after supplementation with a mixture of probiotics. The progression of IBS-C symptoms will also be assessed throughout the study.

The correlation with resolvin D1 levels and the severity of IBS symptoms will be investigated. The efficacy of the probiotic mixture in relieving the symptoms of IBS-C will be measured and compared based on the levels of resolvin D1.

Eligibility Criteria:
Inclusion Criteria:

* Irritable Bowel Syndrome with constipation (IBS-C) according to Rome IV criteria ;
* IBS-SSS between 175-300 in the last 10 days ;
* Have experienced abdominal pain ≥ 40 according to the IBS-SSS questionnaire (abdominal pain item) during the last 10 days ;
* Whose abdominal pain / discomfort has had a significant impact on daily life during the past 10 days (impact ≥2 on a 5-point likert scale (from 0: no impact to 5: extreme impact) ;
* Ability to understand instructions and complete questionnaires Nurstrial APP.
* Affiliate or beneficiary of a social security ;
* Having given their free, informed and written consent.

Exclusion Criteria:

* CPRu \> 10 mg/l
* Pregnant or breastfeeding woman, woman planning a pregnancy during the study period ;
* Intolerance or proven food allergy ;
* BMI \<18.5 kg / m2 or BMI\> 35 kg / m2 ;
* Diagnosis or known history of IBS-D, IBS-M, or unclassified forms of IBS, or other gastrointestinal pathologies ;
* With current first-line IBS-C treatment or second-line treatment ;
* alternative non pharmacological treatment ;
* Drug treatment affecting visceral sensitivity or intestinal transit ;
* dietary modification (exclusion of FODMAPs, prebiotic) or lifestyle ;
* Excessive smoking or drinking ;
* Having or planning bariatric surgery,
* With known pathologies affecting gut function ;
* With a deviant eating behavior,
* Treated with antibiotics in the 3 months preceding inclusion,
* Under legal protection,
* Already included in a clinical trial,
* With severely impaired physical/psychological health may affect study participation.
Forward Head Posture and Myogenic TMD Association in Smartphone Overuse

The goal of this observational study is to determine the correlation between forward head posture and myogenic temporomandibular disorder, pain pressure threshold and endurance of masticatory and neck muscles in addicted smart phone users. The main question it aims to answer is:

• What is the correlation between forward head posture and myogenic temporomandibular disorder, pain pressure threshold and endurance of masticatory and neck muscles in addicted smart phone users?

Temporomandibular joint (TMJ) and cervical spine are closely related to each other due to their anatomical, mechanical and neurophysiological relationships. That's why pain and dysfunction in the cervical spine can be observed in patients with temporomandibular disorders (TMD) who may suffer from clinical problems in the masticatory muscles, the temporomandibular joint and other associated structures.

Millions of people worldwide use their smartphone devices excessively. Prevalence of smartphone addiction among Egyptian university students was 62.4% revealing that females had a higher addiction than men. This excessive use where subjects downwardly flex their neck to enable them to look at the screen, affects head and neck postures leading to forward head posture (FHP) which consequently alters the position of the mandible along with its functions, resulting in an increase tension in the masticatory muscles causing TMD. Addicted smartphone users contribute to changes in craniocervical region which led to myogenic TMD in young teenagers.

Pain, tenderness in masticatory muscles and cervical muscle endurance are common clinical findings in patients with TMD; where muscle tenderness is reduced and cervical muscle endurance was found to have a shorter duration holding time when performing neck extensor endurance test due to higher fatigability of neck extensor muscles.

Eligibility Criteria:
Inclusion Criteria:

1. Subject's age range from 18 - 40 years.
2. Both males and females will be recruited.
3. Subjects diagnosed as myogenic TMD according to the presence of trigger points in masseter, temporalis, upper trapezius and C5-C6 articular pillars according to the myofascial diagnostic criteria that includes a taut band and hypersensitive spot
4. All subjects are heavy smartphones users, using the SAS-SV, the cuffof value for males is 31 and for females is 33.
5. All subjects will have forward head posture assessed by CVA less than 49.9 degrees.

Exclusion Criteria:

1. History of head, neck or TMJ trauma
2. Patients who underwent orthodontic treatment
3. Congenital, or acquired postural deformity
4. No previous neck or spinal or TMJ surgery
5. Subjects who are on anti-inflammatory or analgesic drugs for pain
Morphological Study of Distal Tibio-fibular Joint on MRI

The distal tibio-fibular joint ( DTFJ) be an integral part of the ankle and its injury makes all the gravity, forecast and complexity of ankle fracture treatment. It's classically described and known by radiological point of view, but in static incidence and from anatomical studies. To our knowledge the dynamic dimension and its modelling is missing. Our study will use high spatial-resolution MRI acquisition to obtain the best possible definition of DTFJ but especially it will be associated with MRI acquisition in movement, using typical fast sequences " TrueFISP " and "FLASH" which will allow a precise modelling of joint physiological movements and biomechanics on healthy subjects by a not invasive method. This analysis will be made on a simple movement of flexion and extension, the other possible movements of the ankle being blocked what corresponds to the clinical situation of an osteosynthesis ankle immobilized in post-operative by a dynamic rehabilitation shoe Axmed ® It will be associated an"effort test " with the reproduction of subjected joint of a load with MRI joint movement control This test will be made with an ankle fixed to 90 ° of flexion what reproduces the post-operative clinical situationThe meditative data will be associated with an anatomical biomechanical study of ankles presenting a syndesmosis injury repaired according to the classic protocol using in our department, by comparing them with the data of the literature to optimize techniques repair of this joint. Indeed there is not gold standard surgical technique Main PurposeTo understand, observe, analyze and quantify the joint movement during a simple movement of ankle extension and flexion, and during a simulation of axial load miming walk fixed to 90 ° as in post-operative. Secondary purpose - Modelling the DTFJ- Modify the post-operative care with hypothesis that load does not lead abnormal movement in DTFJ with an ankle fixed to 90 ° ( post-operative clinical condition). - Validate our technique of repair of this joint by comparing the data MRI with anatomical mechanical tests


Eligibility Criteria:
Inclusion criteria:

* major subjects
* without ankle surgical antecedent
* Subject having signed an enlightened consent

Exclusion criteria:

* Subject in exclusion period
* Subject operated for the ankle,
* Impossibility to give an enlightened information
* Subject under protection of justice
* Under guardianship subject
* Patient refusing to participate in the study
* Minor subject
* Pregnant or breast-feeding woman
* Claustrophobic patient
Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients with Advanced Solid Tumor

This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate safety and anti- tumor activity of Q702 administered orally.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed advanced or metastatic solid tumors, that have progressed following standard of care therapy or for which there is no standard therapy which confers clinical benefit
* Measurable disease per RECIST v 1.1
* ECOG performance status 0 or 1
* Life expectancy of at least 3 months
* Age ≥ 18 years
* Signed, written IRB-approved informed consent form

Exclusion Criteria:

* New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months
* Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>470 msec (females) and \>450 msec (males)
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Active, poorly controlled autoimmune or inflammatory diseases
A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema

To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema.

Overall 80% of diabetic patients with low vision are in the nonproliferative stage and the main cause of decreased visual acuity is macular edema.

According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema (DME) is laser therapy, which may be neither effective nor curative in some patients.There are many cases which are refractory to laser treatment or not suitable candidates for it.

Corticosteroids might have a beneficial effect on DME. They have been used with different doses and routes (periocular,intravitreal,and slow released implants) for a variety of retinal diseases.

Recently, a few prospective randomized studies, concerning the effect of intravitreal triamcinolone acetonide (IVT) on DME have been published. In their two-year results, Gillies et al. concluded that IVT improved vision and reduced macular thickness in eyes with refractory diabetic macular edema. They showed that this beneficial effect persisted for up to 2 years with repeated treatment.

We also conducted a randomized placebo-controlled clinical trial to determine the safety and efficacy of IVT for intractable DME. Besides, we tried to evaluate the effect of this intervention on angiographic findings of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinically significant macular edema(CSME)
* Clinically significant macular edema(CSME)refractory to initial or supplemental macular photocoagulation

Exclusion Criteria:

* Mono-ocular patients
* History of vitrectomy
* Glaucoma or ocular hypertension
* Significant media opacity
* Traction on the macula
A Primary Prevention Trial to Strengthen Child Attachment in a Native Community

The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Health Promotion program, and to assess the efficacy of the method in this community.


Eligibility Criteria:
Inclusion Criteria:

1. Primary caregiver for a child aged 10 to 30 months
2. Caregiver lives with the child full time for the past three months and plans to continue for at least 6 more months.
3. Child is an American Indian or Alaska Native living on or near the Tribe's reservation.
4. Caregiver has telephone access
5. Caregiver is willing to have researchers come to their house
6. Caregiver is English speaking
7. Caregiver is willing to participate in a home-visiting program which includes video-recorded sessions of caregivers and their children playing

Exclusion Criteria: Caregiver is

1. Hospitalized or imprisoned
2. Living in a Treatment facility or shelter
3. Unable to give consent
4. Live in a household that already has a dyad enrolled in the study.
Diabetic Neuropathy Topical Treatment

Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus type I or II
* Mono or polyneuropathy
* Treatment with Tricyclic Antidepressant, Carbamazepine during 3 weeks at least
* Preserved cognition

Exclusion Criteria:

* Ulcerative or infection or vesicle lesion in pain site
* Pregnancy
* Breast feeding
Evaluation of the Risks and Benefits of Abdominal Massage Treatment in Neonatalogy in Premature Children

Premature birth creates difficulties for the child in starting his diet and digestion. The immaturity of the major vital functions complicates the abdominal transit. The initial diet, essentially parenteral in the central way, decreases progressively according to the digestive tolerance allowing the increase of the enteral feedings to optimize the growth. To ensure this transition, nurses nurses in Neonatology service, through their knowledge and expertise, practice a daily gesture: abdominal massage-care. This prevents or remedies a slowing of transit. The paramedical clinical examination of the child, determines the realization of this care. Several studies have proved the benefit of massage on the weight gain of premature babies. These stimulate peristalsis, decrease the duration of intestinal transit and the sensations of discomfort and pain related to it. Currently in Neonatology, developmental care (NIDCAP) is an approach to individualized care for the premature to improve its evolution. The fine observation of his behavior allows us to adapt our care and to ensure the respect of his pace. However, the first sensory capacity developed in the fetus, the touch can also be a source of over-stimulation for the premature baby. Moreover, the greater the prematurity, the greater the risk of occurrence of digestive complications. Can the abdominal care-massage in premature babies be harmful or risk increasing existing symptoms? The abdominal care-massage is neither described nor referenced in the nomenclature of nursing, neither taught nor subject to medical prescription.

Few publications exist on this subject, no large-scale research has been reported. On the other hand, the perception of our empirical practice seems to show that the abdominal massage-care is an important aid to the smooth transit of the premature newborn. Transmitted orally by professionals to newcomers to Neonatology, this treatment is carried out in a heterogeneous manner according to professionals. Convinced of its effectiveness, carers wonder about their practice: is there an optimal technique without risk for the child? Determining the absence of risk and the effectiveness of the abdominal care-massage suggests a wider benefit for the well-being and progress of the premature child until he leaves the hospital. This validated practice could be disseminated on a larger scale in other neonatal departments.


Eligibility Criteria:
Inclusion Criteria:

* Children born before 37 weeks of amenorrhea hospitalized in the neonatology department

Exclusion Criteria:

* children with a malformation or a digestive pathology with or without surgery
* medical prescription of non-massage care
* children born under the secret
Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort

The purpose is to evaluate feasibility of medical supervision of professionally active asymptomatic wood workers with questionnaires and nasofibroscopy.

Secondary purposes are:

* Feasibility evaluation of identification of former and actual professional expositions to wood dust and to various naso-sinusal carcinogenics in case of co-expositions (formaldehyde, chrome, nickel, leather)
* Description of abnormal symptoms identified by occupational doctor and needing an otorhinolaryngology test
* Description of results and examinations induced by nasofibroscopy in symptomatic or asymptomatic individuals: counting of naso-sinusal adenocarcinoma cases
* Evaluation of participation of workers retiring in 2 years after inclusion to medical supervision program
* Evaluation of information flow among different players
* Assessment of costs induced by this targeted screening: direct medical costs (screened pathologies, induced additional examinations...) and indirect costs for company (duration of worker absence for transfer, medical and additional examinations).


Eligibility Criteria:
Inclusion Criteria:

* Employee or craftsman
* Actual or former professional exposition to wood dust
* Onset of exposition to wood dust back to more than 30 years (latency \>30 years)
* Cumulated exposition to wood dust longer than 12 months
* Exposition to wood dust during machining tasks (sawing, milling, planing, drilling, bridging) or all documented activities exposing to wood dust concentration \> 1 mg/m3 for 8 hours
* Worker followed by occupational doctor of participant occupational health departments
* Worker accepting medico-professional supervision recommended by guidelines
* Affiliation to social security

Exclusion Criteria:

* Difficulty with comprehension of wood auto-questionnaire
Comparison Trial Between Elastic-compressive Stockings at 21 Versus 32 mmHg

Endovascular thermal ablation is currently considered as the best procedure for treating varicose veins thanks to its mini-invasiveness and the lowest rate of incidence of complications. At the end of the endovascular ablation procedure, the European Society of Vascular Surgery (ESVS) guidelines recommend the use of the compression stockings to reduce postoperative pain and the incidence of edema and thrombotic complications.

Despite this, the duration, type and degree of compression to be used, particularly after radiofrequency ablation procedures, remain a matter of debate. Furthermore, although the benefits of postoperative elastic compression therapy are well known, there is various evidence demonstrating how patients often experience poor comfort in wearing stockings, especially those with a higher degree of compression, which causes poor compliance with therapy. In light of all this, each center recommends the use of elastic compression stockings in the postoperative period with a degree of compression that varies, however, according to internal protocols.

There is currently no work in the literature that compares the advantages and disadvantages of using elastic compression stockings with a K2 versus K1 compression degree after radiofrequency ablative surgery.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (\>18 years) suffering from varicose vein pathology of the lower limbs C2-3 class (varicose veins, edema) according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification, supported by incontinence of the great saphenous vein documented by Echo-Duplex study and candidates for thermal ablation by radiofrequency of the great vein saphenous vein with associated phlebectomy of the ipsilateral thigh and/or leg varices.

Exclusion Criteria:

* Patients who are minors (\< 18 years old) or adults who have not given their consent to participate in the study.
* Presence of severe obliterating arterial disease of the lower limbs (ABI \<0.5)
* Obesity (BMI \>30)
* Varicose pathology of the lower limbs in C4-C6 class according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification (presence of:

lipodermatosclerosis/eczema and/or ulcers in progress and/or previous ulcers in the affected lower limb).

* Pregnancy.
A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy

The purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants aged 12 years and older
2. Participants who were diagnosed with partial-onset seizures with or without secondarily generalized seizures.
3. Participants who were appropriate to receive Fycompa® as an adjunctive treatment participants starting at Visit 0 according to investigator's judgment.
4. Participants who had provided written informed consent

Exclusion Criteria:

1. Participants not fit to receive Fycompa® as per the latest prescribing information.
2. Participants who were participating in a clinical trial, at the time of the study.
3. Participants who showed evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.) that in the opinion of the Investigators could affect the participant's safety or trial conduct.
4. Participants who according to the Investigators would not be able to comply with study procedures.
Dose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia

The main purpose of this study is to test the safety and efficacy of VS-4718 in two types of leukemia patients and to find the right dose of VS-4718 for future clinical trials.

Other purposes of this study include:

* Testing for study drug VS-4718 levels in blood over time and what happens to the study drug in patients.
* To find out if there are certain biomarkers in leukemia patients that predict if and how 4718 study drug may or may not work.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Pathologic confirmation of AML or B-ALL
* Must have relapsed or refractory AML or B-ALL with no alternate therapy of proven benefit
* ECOG status of 0 or 1
* Adequate renal function \[creatinine less than or equal to 1.5x ULN\] or GFR of at least 60mL/min
* Adequate hepatic function via total bilirubin, AST, and ALT
* Corrected QT interval of less than 470 ms (via Fridericia correction formula)
* Negative pregnancy test for women of child bearing potential
* Willingness to use adequate birth control throughout participation for both men and women

Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia
* Active grade 2 or higher acute GVHD at time of study entry or active chronic GVHD (moderate or severe)
* Gastrointestinal conditions which could interfere with the swallowing or absorption of study medication
* Diagnosis of currently active CNS leukemia
* Known infection with HIV or AIDS (testing not required)
* Known active Hepatitis A, B or C (testing not required)
* Patients being actively treated for a secondary malignancy
* Cancer-directed therapy within 14 days of the first dose of study drug or 5 half-lives, whichever is longer
* Major surgery within 28 days prior to the first dose of study drug
* Use of an investigational drug within 28 days or 5 half-lives whichever is longer
* Women who are pregnant or breastfeeding
* Evidence of uncontrolled infections requiring antibiotic therapy; potential subjects with known or suspected infections on stable antibiotic therapy for 72 hours may be enrolled
* Uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements