cyrilzakka/clinical-trials huggingface dataset:
Echotexture in Following Muscle Fibrosis

Objective: To document the sternocleidomastoid (SCM) muscle fibrosis in congenital muscular torticollis (CMT) infants with quantified echotexture and measured thickness during the treatment course.

Design: Cohort study. Setting: Rehabilitation department in a tertiary care hospital. Participants: Infants with clinical diagnosis of CMT, without any neurological presentation, cervical spin abnormality, and developmental dysplastic hip problem, were recruited in the study.

Intervention: All subjects had physiotherapy for at least 3 months. They underwent at least two times of clinical assessment and ultrasonographic examination (1) for bilateral SCM muscles during the follow-up period.

End of follow-up: Subjects who still had prominent clinical presentations after physiotherapy for 6 months or were older than 1 year would receive surgery. Subsided presenting clinical features determined by the clinician was the other end-point of this investigation.

Main Outcome Measures: The K value, derived from the difference of echo intensities (2) between the involved and uninvolved SCM muscles on longitudinal sonograms, was used to represent the severity of muscle fibrosis in CMT infants. Bilateral SCM muscle thickness and involved-to-uninvolved thickness ratio (Ratio I/U) were also obtained from longitudinal sonograms. Clinical outcome was also recorded.

1. An experienced sonographer performed ultrasonographic examination with the subject in the supine position and heads rotated contralaterally to the examination side. A 5-12 MHz linear-array ultrasound transducer was used to observe both longitudinal and transverse views of bilateral SCM muscles for each subject. The ultrasound system settings, including gain (86%), monitor dynamic range (70 dB), and depth (2 cm), were kept constant throughout the study.
2. The echo intensity was determined by computer-assisted gray scale analysis and was calculated in MATLAB 2006b. The mean echo intensity of every pixel in the region of interest and the K value developed to compare sonograms between different individuals or between different times in the same subject were estimated as the previous study (PMID: 22215768)

Eligibility Criteria:
Inclusion Criteria:

* infants with congenital muscular torticollis Presenting clinical features of the CMT infants, including head tilt in the upright position, facial asymmetry, limited passive range of motion in neck rotation, palpable neck mass

Exclusion Criteria:

* Subjects with neurological symptoms or signs
* Cervical spine abnormalities
* Developmental dysplastic hip problems
Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls

Reproducibility of strength testing and functional testing of the hip for the return to sport of patients activated by a femoroacetabular impingement: comparison between a group of patients and a group of healthy controls Femoroacetabular impingement is a disorder movement-related hip clinic, with bone abnormality at the joint coxo-femoral associated with a triad of symptoms, clinical signs and findings imagery. It represents premature contact symptomatic between the femur and the acetabulum. Currently, there is no consensus for determine when to return to sport securely after processing arthroscopy of a emoroacetabular impingement. Various clinical tests are used to assess the mobility or pain but no test studies specifically the level of recovery functional.

Reproducibility of strength testing and functional testing of the hip for the return to sport of patients activated by a femoroacetabular impingement: comparison between a group of patients and a group of healthy controls Femoroacetabular impingement is a disorder movement-related hip clinic, with bone abnormality at the joint coxo-femoral associated with a triad of symptoms, clinical signs and findings imagery. It represents premature contact symptomatic between the femur and the acetabulum. Currently, there is no consensus for determine when to return to sport securely after processing arthroscopy of a emoroacetabular impingement. Various clinical tests are used to assess the mobility or pain but no test studies specifically the level of recovery functional.

Eligibility Criteria:
Inclusion Criteria:

Patients

* Male or female aged 16 to 50
* Occurrence of the injury requiring surgery during a sports activity
* Hip arthroscopy
* Surgery performed by surgeons from the Santy Orthopedic Center (Lyon)
* Angle Alpha \> 55°
* Patient having signed an informed consent
* Affiliated subject or beneficiary of a social Security

Control group

* Male or female aged 16 to 50
* Practicing a regular sporting activity In both groups
* Patient having signed an informed consent
* Affiliated subject or beneficiary of a social Security

Exclusion Criteria:

Patient group

* Contraindication of the surgeon
* Present another pathology of the hip on the side of the operated limb or on the contralateral side

Control group

* Declare a history of lower limb pain/injury in the last 12 months
* Declare a history of orthopedic surgery on the lower limbs

In any case will be excluded Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy

The goal of this observational study is to measure the levels of cytokine-induced transcription factor activation in a cohort of depressed inpatients undergoing psychotherapy. The study aims to answer the following main questions:

* Do psychological traits (i.e.: social inhibition, negative affectivity, ...) affect the activation of immunomodulatory transcription factors (STAT3, NFkB) in depressed patients?
* Are subjects with these psychological traits affected differently by psychotherapeutic intervention?

Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry.

Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of current depression

Exclusion Criteria:

* inadequate knowledge of the German language
* unable to give informed consent
* severe psychiatric comorbidities, such as drug abuse and psychotic diseases
* deemed critically unstable by their treating physician
The SMARTEX Heart Failure Study

This protocol describes a randomized multicenter clinical trial designed to test the hypothesis that a 12-week program of high-intensity interval training (HIIT) yields larger beneficial effects in stable heart failure patients than current practice, defined as either a similar training program with the same volume of moderate continuous training (MCT) or a recommendation of regular exercise at moderate intensity at individual choice (RRE).

Evaluation criteria are left ventricular dimensions and function measured by echocardiography, aerobic capacity measured as peak oxygen uptake, quality of life, and the level of physical activity by questionnaires. Assessments will be made before and after the training program and at one year follow-up. Safety of HIIT will be assessed as incidence of adverse effects during the training program. Clinical events will be recorded as worsening of heart failure requiring intensified drug therapy (diuretics), ventricular arrhythmia, hospitalization due to cardiovascular disease, and all-cause mortality at one year follow-up. The core study has been initiated and endorsed by the European Association for Cardiovascular Prevention and Rehabilitation, Section for Basic and Translational Research, under the European Society of Cardiology, and allows for sub-studies involving one or more of the participating centers. Preliminary calculations suggest that a total number of 200 patients randomized 1:1:1 to the three intervention groups is needed to detect larger beneficial effects with HIIT with a p-value of 0.05 and statistical power of 0.90 (primary endpoint is reverse remodeling, assessed by comparison between groups of change in left ventricular end-diastolic dimension from baseline to 12 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Congestive heart failure after myocardial infarction or dilated cardiomyopathy with:

  * LVEF \< 0.35,
  * NYHA class II - III,
  * Stable without any signs of worsening for at least 6 weeks,
  * Minimum 3 months of optimal medical treatment,
  * Previous revascularisation or CRT should be more than 6 months before inclusion.

Exclusion Criteria:

* Significant intercurrent illness last 6 weeks,
* Known severe ventricular arrhythmia with functional or prognostic significance unless protected with ICD,
* Significant ischemia,
* Hemodynamic deterioration or exercise-induced arrhythmia at baseline testing,
* Other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.,
* Co-morbidity that may significantly influence one-year prognosis,
* Functional or mental disability that may limit exercise,
* Patients scheduled for heart transplant at time of inclusion,
* A habit of regular vigorous exercise or participation in a program of exercise training less than 6 months before inclusion, or participation in another clinical trial,
* Patients with COPD with FEV1 below 50% of expected values are excluded,
* Patients taking oral corticosteroids are excluded in all cases.
Covid-19 Pediatric Observatory

In early December 2019, cases of pneumonia of unknown origin were reported in Wuhan, Hubei Province in the People's Republic of China. The disease spreads rapidly and the number of sick people is increasing. On January 3, 2020 a new virus of the coronavirus family is identified in samples of bronchoalveolar lavage fluid from a patient in Wuhan and subsequently confirmed as the cause of these pneumonias. On 7 January 2020, the World Health Organization (WHO) designated it as the new coronavirus 2019 (i.e. 2019-nCoV). On 11 February 2020, the WHO designated the disease associated with 2019-nCoV as coronavirus 2019 disease (COVID-19). On 12 March, WHO announced that the COVID-19 outbreak is a pandemic.

As of March 24, 2020, more than 375,000 cases of COVID-19 had been diagnosed with more than 16,000 deaths attributed to this virus. (Ref WHO https://www.who.int/emergencies/diseases/novel-coronavirus-2019 ).

In France, the number of cases rose from 105 cases at the end of February to 19615 confirmed cases on March 24. (Source Public Health France). Most of the cases are adults. However, children are not completely spared and serious cases have been described. These severe cases can be respiratory or extra-respiratory (e.g. myocarditis). We also know that pediatric and adult cases differ in terms of clinical, biological and imaging findings, particularly chest CT scans. However, the description of paediatric pictures, especially severe forms and the involvement of children suffering from co-morbidities, remains poorly reported. Finally, the risk factors for serious cases in children remain largely unknown.

This observatory aim to describe the clinical phenotypes of hospitalized pediatric patients with Covid19 in France, according to age groups. Moreover for a subgroup of patients, informations regarding the long covid will be reported.


Eligibility Criteria:
Inclusion Criteria:

* Children \< 18 years old
* Admitted in French pediatric wards
* With a confirmed COVID-19 infection. ( on Nasal and pharyngeal swab specimens or blood samples tested positive for 2019-nCoV nucleic acid using real-time reverse-transcriptase polymerase-chain-reaction (RT- PCR) assay; or on typical chest CT signs

Exclusion Criteria:

* Expressed refusal to participate
Foot Posture in People With Paralysis on One Side After Stroke

People who have had a stroke often have difficulty walking and problems with their balance. The purpose of this project is to examine problems with foot postures in people who have weakness on one side of their body

The specific aims of this study are to:

1. Describe foot posture in individuals with hemiplegia following stroke using a quantitative navicular drop test.
2. Determine differences in people with normal, hypotonic, and hypertonic foot posture with regard to ankle range of motion, ankle strength, gait, and balance.

This is an observational design study to describe relationships between the variables. Measurements will include both descriptive and quantitative measures.

Thirty subjects with stroke will participate in one session of testing which will include: clinical assessment of foot posture using a descriptive classification system, quantitative measurement of navicular drop during standing, measurements of ankle range of motion, ankle strength, gait (lower extremity biomechanics and forceplate analysis), and static and dynamic balance. A chi-square test will be used to determine goodness of fit between classification with the descriptive system and the quantitative measurement. Independent one-way ANOVAs will be used to determine the mean differences in the foot posture groups for each of the dependent variables.

Eligibility Criteria:
Inclusion Criteria:

* subjects must have a diagnosis of a single stroke with resultant hemiplegia and be able to stand up from a seated position and walk 30 feet without assistance.

Exclusion Criteria:

* Subjects will be excluded if they present with significant foot or ankle pathology, other medical problem that would affect gait or balance, or language / cognitive deficits that would impair ability to give informed consent.
A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)

AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

AZ201801 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 sequentially overlapping cohorts evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older
* Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
* Evidence of meibomian gland obstruction
* Reported dry eye signs and symptoms within the past 3 months

Exclusion Criteria:

* Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
* Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at screening ≥24 mm Hg or has planned insertion/removal of glaucoma filtration shunts/devices during the study
* Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
* BCVA worse than 20/40 in either eye
* Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia

The primary aim of this study is to test the hypothesis that Heller myotomy and Toupet fundoplication result in a lower rate of reflux symptoms and positive 24-hour pH testing when compared to Heller myotomy and Dor fundoplication.

Idiopathic achalasia is an uncommon motor disorder of the esophagus which occasionally requires surgical intervention. Although there are several controversial aspects of therapy for achalasia, laparoscopic myotomy is emerging as the procedure of choice. Several studies report having good to excellent outcomes following a laparoscopic procedure in approximately 90% of patients. However, a main deterrent to long-term success is the development of gastroesophageal reflux disease (GERD) despite the use of an antireflux procedure. For this reason, most surgeons add a partial fundoplication to the myotomy. The gastric fundus can either be wrapped anterior to the esophagus (Dor fundoplication), or posterior to the esophagus (Toupet fundoplication). Currently, the type of fundoplication is determined by surgeon's choice. There exists no systematic comparison of the two procedures. This multicenter, randomized study aims to evaluate patient outcomes following myotomy and Dor versus Toupet fundoplication.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Achalasia

Exclusion Criteria:

* Prior heller myotomy
Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy

The main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy.

The time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the National Health Data System).

The secondary objectives of this research are to compare the following between the two groups:

* The actual cost of the surgical prostatectomy.
* Erectile function at 0, 1, 6, 12 and 24
* Oncological results at 1, 6, 12 and 24 months.
* Functional results at 0, 1, 6, 12 and 24 months.
* Quality of life at 0, 1, 6, 12 and 24 months.
* Complication rates at 1 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 24 months of follow up
* Patient has localised prostate cancer
* Patient is eligible for radical prostatectomy

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Patient has a contraindication for a treatment necessary for this study
* Patients with psychiatric disorders
The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT

This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3-ITD positive AML patients after allo-HSCT in terms of gut microbiome.

Hematopoietic stem cell transplantation (HSCT) is used as a potentially curative therapy for patients with hematopoietic malignancies. Sorafenib, an inhibitor of multiple kinases including FLT3, has shown promising activity in FLT3-ITD-positive AML. Our previous studies demonstrated that sorafenib maintenance post-transplantation could improve the outcomes of FLT3-ITD-positive AML patients, which is associated with sorafenib enhancing the graft-versus-leukemia (GVL) effect. Some studies show that gut microbiome is associated with graft-versus-host-disease (GVHD) and GVL. However, the effect of gut microbiome on sorafenib maintenance after allo-HSCT remains unknown.

Eligibility Criteria:
Inclusion Criteria:

* FLT3-ITD Positive AML
* Allo-HSCT Recipients

Exclusion Criteria:

* intolerance to sorafenib pretransplantation
* Cardiac dysfunction (particularly congestive heart failure)
* Hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
* Renal dysfunction (creatinine clearance rate \< 30 mL/min)
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (according to the investigators' decision)
Optimization of the Healing Process of the Uterine Scar Tissue After Re-cesarean Section

This prospective, controlled, clinical, intervention study measures the number of uterine Cesarean section scars and median myometrial thickness of women who underwent two Cesarean sections six to nine months after their last Cesarean section using transvaginal ultrasound.

It is the purpose of the study to assess if a resection of the uterine scar from a previous Cesarean section during a second Cesarean section could lead to a decrease in risk for subsequent pregnancies.

The average number of Cesarean sections in Germany has doubled from 1991 to 2011, making up 32,1% of all deliveries in 2011.

Several studies describe instances in which pregnancies following a previous Cesarean section were accompanied by complications such as life-threatening bleeding, placenta previa, placenta accreta, increta or percreta and dehiscence or uterine rupture.

The risk of those complications increases further with the uterine scar tissue of a second Cesarean section.

Today it is already common practice to resect uterine scars if the scar of a previous Cesarean section becomes symptomatic, or when a non-symptomatic uterine rupture or serious dehiscence are discovered during a Cesarean delivery.

In this study all participants of the interventional group are examined via intraoperative ultrasound to identify the first uterine Cesarean section scar and resect it completely.

Six to nine months after the resection participants will return for a one time follow-up. At this time, the investigators will measure the number of uterine scars and median myometrial thickness using transvaginal ultrasound. The results will be compared with those of two control groups, consisting of women who underwent either one or two Cesarean sections without the intervention.

The aim of the present study is to asses if the number of uterine scars and median myometrial thickness can be improved by the resection of the first uterine scar during a subsequent Cesarean section.

This will allow the investigators to draw conclusions regarding the benefit of routine resections of uterine Cesarean section scars, and whether this practice could lead to a decreased risk for women undergoing two or more Cesarean sections.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* primary or secondary indication for cesarean section 6 to 9 months prior to the examination date

Exclusion Criteria:

* \<18 years old
* current pregnancy
* congenital deformity of the uterus
* former surgery of the uterine myometrium
Tahini and Dermatitis in Breast Cancer

This study aimed to investigate the effect of tahini on acute radiation dermatitis in breast cancer (BC) patients undergoing radiotherapy (RT).

50 eligible BC patients will randomly assign to consume tahini 48 gr per day during and 1 week after RT or with no intervention (control group). The radiation dermatitis will be assessed weekly according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) scales.


Eligibility Criteria:
Inclusion Criteria:

* women with Brest Cancer undergoing adjutant Radiation therapy

Exclusion Criteria:

* previous history of RT, MRM,
* concomitant presence of two or more malignant tumors
* metastasis to other areas
* allergy or intolerance to tahini
* skin diseases and wounds
* severe liver and renal disease
* autoimmune diseases
* pregnant and lactating women
* those who treated with hypo fraction RT