cyrilzakka/clinical-trials huggingface dataset:
Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context

Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. In a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved.

Descriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome.

The PENELOPE clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters.

The data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.


Eligibility Criteria:
Inclusion Criteria:

* Girls aged 6 to 8 years
* Presenting a breast development (isolated or not)
* Undergoing scheduled pediatric day hospital care (HDJ)
* Who agree to participate in the study
* Whose parents agree to their child's participation in the study
* French speaking
* Whose parents speak French
* Affiliated to social security

Exclusion Criteria:

* Organic brain causes of precocious puberty: History of neurocerebral disease (malformations, developmental abnormalities)
* Organic causes of precocious puberty: Mac Cune Albright syndrome, ovarian cyst or tumor and adrenal hyperplasia
* History of chemotherapy or radiation therapy
* Presenting with a communication disorder
* Pregnancy
* Persons under protective measures
* Persons deprived of liberty for judicial or administrative reasons
Undislocated Distal Both-Bone Forearm Fractures in Children

We create a randomized clinical trial between above- and below elbow cast to find out what kind of treatment is optimal for undislocated both-bone distal forearm fractures.

children who arrive at the emergency unit with a undislocated both-bone distal forearm fracture will be asked to join the trial.

After informed consent, a randomization between 2 kinds of cast will be done.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Eligibility Criteria:
Inclusion Criteria:

* both-bone forearm fracture
* distal
* undislocated
* age \< 16 years

Exclusion Criteria:

* fracture older than 1 week
* no informed consent
* refracture
* open fracture (Gustillo 2 and 3)
* both fractures type torus
UK - EHL Outcomes Registry

Severe haemophilia A and B (SHA, SHB) are inherited bleeding disorders affecting male patients and are characterised by low levels of circulating clotting factors VIII and IX respectively. Clinically low levels present with multiple recurrent bleeds into joints and muscle from the first couple of years of life. In addition patients may present with spontaneous and potentially fatal bleeding into any organ. The mainstay of treatment is replacement with the missing factor in the form of intravenous injections of factor VIII and IX. Clotting factors can be given to treat a bleed or can be given to prevent a bleed, and the latter is termed prophylaxis. Regular prophylaxis is the current standard of care and aims to decrease spontaneous bleeding events and resulting joint damage, and this requires patients to self-infuse factor into their veins two to four times week. Patient's compliance with prescribed regimen and recommendations has a significant influence on outcomes.

Advances in biomolecular and protein engineering have extended the duration of the effect of clotting factor VIII and IX through multiple mechanisms. This extension of the duration of the effect presents the clinician and patients with opportunities to tailor the treatment to their particular needs, circumstances and body other characteristics. It has been suggested that decreasing the frequency of infusions will improve adherence and thus contribute to improved outcomes.

In rare disorders, it is an accepted fact that post-marketing studies are crucial to understand the generalisability of the efficacy and safety outcomes and identify any new safety and efficacy concerns in relation to specific population group. The investigators propose the development of a registry for systematic collection of information with the dual aim of analysing the relationship between patient and treatment characteristics, and outcomes, and simultaneously identify areas for practice development that can improve the overall quality of life experienced by the haemophilia patient community.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Haemophilia A or B requiring replacement therapy
2. Patients or parents able to provide informed consent
3. Patients being considered for use of EHL - CFC.

Exclusion Criteria:

1. Patients currently enrolled into a clinical trial of investigational medicinal product.
Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Balance confidence is not necessarily related to functional abilities. It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence. Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities. The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.

Lower limb prosthesis users, with self-reported low balance confidence complete baseline gait analysis and balance testing, as well as a series of validated self-reported outcome scales addressing balance confidence, quality of life, and community integration. Participants are then provided a step activity monitor (SAM) and a global position sensing (GPS) tracker to be worn for one week, the data from which is linked and used to objectively quantify baseline community participation. At the conclusion of the one week, participants are randomized to one of two groups, each of which will last for 8 weeks. At the conclusion of the eight weeks, participants repeat baseline assessments and are again provided a SAM and GPS tracker to wear for one week. Baseline measures and activity monitoring occur again 8 and 16 weeks thereafter.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* unilateral lower limb amputation without serious complications
* at least 6 months experience using a definitive lower limb prosthesis
* Activity Specific Balance Confidence (ABC) scale score≤80
* self-reported concern about balance that limit activities

Exclusion Criteria:

* active wounds on weight bearing surfaces
* inability to perform the protocol without an assistive device
* currently seeing a physical therapist for any reason
* history of neurodegenerative disease
* history of stroke
* ill-fitting or ill-functioning prosthesis (to be verified by research prosthetist during screening)
* prohibited by primary care physician or research physician to participate in mild exercise
Changes in Esophageal Distensibility With Proton Pump Inhibitors in Patients With Esophageal Eosinophilia: A Pilot Study

This pilot study will explore whether treatment of eosinophilic inflammation in the esophagus is associated with an improved distensibility of the esophagus. Furthermore, previous studies of the esophagus using EndoFlip only measured distensibility of the distal esophagus, specifically the distal esophagus and esophagogastric junction. Eosinophilia in EoE has been demonstrated to affect both upper, middle and lower esophagus. The aim is to measure distensibility both proximal and distal, before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Presence of eosinophilia on esophageal biopsy, defined as a peak count of \> 15 eosinophils per high power field (HPF) on light microscopy based on biopsies from at least 2 of the 3 biopsy segments (upper, middle and distal esophagus)

Exclusion Criteria:

1. Secondary causes of esophageal eosinophilia has been excluded, such as eosinophilic GI diseases, celiac disease, Crohn's disease, esophageal infection, hypereosinophilic syndrome, drug hypersensitivity, vasculitis, pemphigus, connective tissue diseases, graft vs. host disease
2. Age \< 18 or \> 65 years
3. Contraindication for biopsy, such as presence of esophageal varices, coagulopathy
4. History of esophageal surgery, gastric or esophageal malignancy, anatomical abnormality, or major primary motility disorder (such as achalasia)
5. Pregnancy
6. Prisoners
Identification of Novel Targets for Regulation of Adipose Tissue Mass

The aim of this study is to understand the metabolic changes occurring in fat tissue both during controlled weight loss that lead to the improvement of type 2 diabetes and other obesity associated metabolic disorders. The novelty of the study is the analysis of preadipocytes, a poorly characterized subfraction of the adipose tissue, which provides adipocyte precursors and thereby strongly influences adipose tissue mass changes. Knowledge of pathways involved in controlling adipose tissue composition will help to design novel intervention strategies for the treatment of obesity associated metabolic disorders such as type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Participants of the OPTIFAST52 program
* BMI \> 30 kg/m2

Exclusion Criteria:

* Rejection of informed consent by the participant
z Mini-plate With Lingual Extension Versus Conventional 2 Mini Plates

The collected patients according to the eligibility criteria will be randomly distributed into one of these groups:

Group I : 10 patients suffering class III mandibular fracture will be managed by patient specific Z shape mini-plate with lingual extension (study group).

Group II : 10 patients suffering class III mandibular fracture will be managed by 2 mini plates at superior and inferior borders (control group).

The allocation sequence will be generated using computerized random numbers and kept in sealed envelopes, which will be opened prior to surgery. All patients will provide the informed consent after declaration the procedures, benefits, and harms


Eligibility Criteria:
Inclusion Criteria:

* - Class III mandibular fracture
* medically stable patient
* aged above 21 years
* no medical condition affect the bone healing

Exclusion Criteria:

* • absence of other facial trauma, mandibular condylar fracture

  * patient refuse the follow up
Research on the Mechanisms of Treatment Non-response in Inflammatory Bowel Disease Based on Multi-omics Technology

In recent years, biologic agents such as infliximab, vedolizumab, and ustekinumab have demonstrated tremendous potential in the treatment of inflammatory bowel disease (IBD), altering the traditional treatment paradigm for IBD. Despite their significant efficacy, there remains a subset of patients who do not respond to biologic agents, necessitating research into the response mechanisms of biologic therapy to explore more precise treatment strategies. Preliminary work by the principal investigator has identified multiple potential responder cell subtypes to biologic agents, which may be influenced by the gut and oral microbiota. Therefore, this project proposes to investigate the mechanisms of response to biologic agents, aiming to explore more precise treatment strategies, through the integration of single-cell transcriptomics, 16S rRNA, and other multi-omics technologies on tissue samples, feces, saliva, peripheral blood, etc., from IBD patients before and after treatment. This will involve integrating bioinformatics analysis and in vitro/in vivo functional validation to elucidate the roles of treatment-responsive cell subtypes and gut and oral microbiota in the inflammatory microenvironment of the intestine, with the aim of uncovering the mechanisms of biologic agent therapy and providing new clues for the development of next-generation drug targets.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older; diagnosed with inflammatory bowel disease according to the 2019 European ECCO-ESGAR guidelines; who have not previously received any biologic therapy or, based on the treating physician's judgment, require treatment with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) after 3 months of medication.

Exclusion Criteria:

* Patients who refuse treatment with infliximab, adalimumab, vedolizumab, or ustekinumab for various reasons, or those with contraindications; patients currently using antibiotics or who have been in contact with probiotics/antibiotics in the past month; those with concomitant active autoimmune diseases, active tumors, etc.; those with severe oral diseases; patients experiencing other diseases unrelated to inflammatory bowel disease during treatment but may affect the efficacy of inflammatory bowel disease treatment; pregnant or lactating women; those deemed unsuitable for participation in this study by the investigator's judgment.
Implementation Supports to Reduce Burnout in Therapists Delivering Child Trauma EBPs

The majority of children exposed to early adversity and trauma do not have access to sustainably delivered evidence-based mental health programs (EBPs), despite the growing prevalence of large-scale multiple-EBP implementation efforts aimed at increasing access to these services. The objective of this proposal is to develop and test a package of implementation strategies designed to promote the sustained delivery of child trauma EBPs by reducing provider turnover through targeting the associated mechanisms of provider burnout and organizational psychological safety climate. Findings will have a significant public health impact by informing efforts to increase the sustained availability of child trauma EBPs, thereby improving outcomes for children exposed to trauma.

Many evidence-based mental health interventions have been developed to address the negative outcomes associated with child exposure to early adversity and trauma. Despite these promising advances, however, the majority of children served in publicly funded mental health systems do not receive evidence-based programs (EBPs). To address this research-to-practice gap, several large-scale, system-driven implementation efforts of multiple trauma EBPs have been launched over the last decade, including in the states of California and Arkansas. Though these system-driven initiatives often increase EBP delivery in community settings following the initial implementation push, long-term sustainment of EBP delivery is low. Workforce risk factors, such as provider burnout leading to turnover, have been identified as contributing to the poor long-term sustainment of trauma EBPs. Therefore, an important step to consider in supporting the longterm sustainment of child trauma EBPs is to develop implementation strategies that target provider burnout and organizational climate factors associated with decreased provider retention. This study will develop and pilot a package of implementation strategies, "Supporting Providers \& Preventing the Overwhelming of Resources in Trauma Systems" (SUPPORTS), aimed increasing the sustained delivery of trauma EBPs by addressing the factors associated with provider retention related to burnout. The development of SUPPORTS will be informed by a needs assessment conducted with programs involved with the multiple-EBP implementation efforts in California and Arkansas. A small randomized controlled pilot will then be conducted in California.

Eligibility Criteria:
Inclusion Criteria:

* Therapists who have delivered Trauma Focused Cognitive Behavioral Therapy (TF-CBT) in the past 6 months.
* Children aged 3-18 years old who is receiving TF-CBT from therapist enrolled in study.

Exclusion Criteria:

* Therapists employed at their current agency for less than 6 months.
* Children less than 3 years old or older than 18 years old.
Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured

After spinal cord injury, patients have frequent urinary tract infections (UVI). Vitamin C is usually prescribed to prevent such infection, but the efficacy of the treatment is poorly documented. In the study, patients will be randomised either to receive vitamin C daily, or not, for one year, and clinical episodes of UVI will be registered. The null hypothesis is that vitamin C will not reduce the number of UVI episodes by 30%.

The study is an investigator-blind randomised parallel study on the efficacy of vitamin C to prevent urinary tract infections in stable, ambulatory spinal cord-injured patients. To be included, patients should have had at least 3 previous UVI episodes over the last two years. 40 patients are included. Patients are randomised to receive either 1 g vitamin C b.i.d. over 1 year, or no vitamin C. The main outcome is the number of clinical UVIs that have been treated with antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* spinal cord injury
* 3 or more episodes of UVI over previous 2 years

Exclusion Criteria:

* pregnancy
* age \<18
* continuous use of antibiotics, hippuric acid or crane berry juice
Study to Increase Colorectal Screening

The purpose of this study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone.

Colorectal cancer (CRC) screening saves lives, but screening rates are low among underserved populations, particularly Latinos. The screening rate in the predominantly Latino population served by San Ysidro Health Center (SYHC, a Federally Qualified Health Center (FQHC)), is just 31%, similar to that reported for Latinos nationally, but lower than the overall national average of 65%. Previous research has demonstrated that inreach interventions at point of medical care such as patient navigation after screening referral, and outreach outside of usual medical care (such as with mailed invitations) can increase screening rates among underserved populations. However, since these have undergone limited evaluation among low income predominantly Spanish-speaking Latinos, it is unclear which approach is best, and whether implementing both approaches would be synergistic for optimizing screening rates. We hypothesize that two culturally and linguistically tailored interventions: a) an inreach strategy (IR, consisting of community health worker-delivered in clinic education regarding CRC screening and other components), and b) an outreach strategy (OS, consisting of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) and telephone reminders) can substantially increase screening, and further, that the two interventions together will be substantially better than either alone. To test these hypotheses, we propose a randomized trial comparing usual care, IR, OS, and IR+OS for CRC screening.

Eligibility Criteria:
Inclusion Criteria:

* Individuals age 50 to 75 years,
* One or more SYHC visits in the last year,
* Not uptodate with CRC screening

Exclusion Criteria:

* Individuals with personal history of CRC or colorectal polyps
Clinical Effectiveness of Boxing Training in Individuals With Elevated Blood Pressure or Stage 1 Hypertension

The goal of this clinical trial is to determine whether boxing training reduces cardiovascular risk in elevated blood pressure or hypertension stage 1 individuals.

The main questions it aims to answer are (1) if boxing training reduces peripheral and central blood pressure and (2) if boxing training improves cardiovascular function in elevated blood pressure or hypertension stage 1 individuals.

Participants with elevated blood pressure or hypertension stage 1 will be randomly divided into a control group or an intervention group. The latter group will be involved in boxing training, 3 days per week for 6 weeks.

Researchers will compare clinical and cardiovascular outcomes between the control and the intervention group.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old.
* Systolic blood pressure between 120-139 mmHg and/or diastolic blood pressure between 80-89 mmHg obtained from 2 different days.
* an estimated 10-year risk of CVD ≤10%, calculated by the ACC/AHA Pooled Cohort Equations.
* no current participation in 3 or more days per week of endurance or resistance exercise training.

Exclusion Criteria:

* non-controlled cardiac, pulmonary, or metabolic diseases.
* smoking, consumption of nutritional supplements containing antioxidants.
* any physical impairment to exercise.
A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma

The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Out patient at least 18 years of age
* Both genderds; females of childbearing potential must be willing to use birth control method
* A diagnosis of asthma at least 6 months prior to Screening
* A best FEV1 of at least 50% of the predicted nomal value at Screening
* Subjects have been receiving maintanance therapy for asthma, for at least 4 weeks prior to Screening

Exclusion Criteria:

* History of life-threating asthma
* Respiratory infection or oral candidiasis
* Asthma exacerbation within 12 weeks
* Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drugs7 excipients, medications related to study drugs
* Taking another investigational medication or medication prohibited for use during this study