cyrilzakka/clinical-trials huggingface dataset:
Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema

Thoracic surgeons have developed a thoracoscopic procedure which is less intrusive method allows complete evacuation and washing of the debris from the pleural cavity. This approach may also have the benefit of less invasive maneuver, a shorter hospital stay and a decreased rate of postoperative complications.

The aim of this study is to evaluate the advantages and disadvantages of the video-assisted thoracoscopic surgery (VATS) approach in comparison with thoracotomy in management of empyema in pediatric patients.

comparison between VATS decortication and open thoracotomy in cases of pediatric empyema

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients 1 yrs. : ≤ 18 yrs.
* Patients with empyema due to pneumonia.
* Patients with empyema had lasted for fewer than 3 weeks.

Exclusion Criteria:

* Patients \< 1 yrs. old.
* Patients with whom pleural empyema had lasted for more than 3 weeks.
* Patients with empyema had been caused by trauma.
* Patients whose parents refuse to be included in the study.
* Patients with empyema due to ruptured lung abscess.
* Patients with empyema due to chest wall abscess.
* Patients with empyema due to rib osteomyelitis.
* Patients with bronchopleural fistula.
* Patients with post-surgical empyema.
Women Engaging in Quitting Smoking Together (WE QUIT)

The long-term goal of this program of research is to develop and disseminate an efficacious intervention for weight concern that will significantly increase smoking cessation rates among women. The overall objective of this project is to develop this intervention and modify it based on piloting and feedback to ensure its feasibility and acceptability. These objectives will be accomplished by pursuing the following specific aim: 1) develop a group-based distress tolerance treatment for weight concern (DT-W) in female smokers and a comparison health education (HE) program and pilot both treatments with three groups of 10 (total N = 30) female weight-concerned smokers (2 DT-W groups, 1 HE group).


Eligibility Criteria:
Inclusion Criteria:

* female
* 18 to 65 years of age
* smoke 10 or more cigarettes per day
* daily smoker for at least the past year
* report motivation to quit smoking in the next month of at least 5 on a 10 point scale
* report concern of at least 50 on at least one of two 100 point scales assessing weight concern
* able to travel to study location for study appointments

Exclusion Criteria:

* current use of other smoking cessation or weight loss therapies
* current use of other tobacco products at least weekly
* current diagnosis of depression
* diagnosis or treatment for non-nicotine substance use disorder with substance use during the past 6 months
* lifetime diagnosis or treatment of eating disorder, bipolar disorder, schizophrenia, or schizoaffective disorder
* current use of psychotropic medication except antidepressants
* score above established cut-offs on self-report screening measures of depressive symptomology, eating disorder symptomology, alcohol use disorder, or drug use disorder
* current suicidality or homicidality
* medical condition that is a contraindication for the use of transdermal nicotine patch
* lives at same address as current or past participant
World Digital Detox Program for Enhancing Women's Health & Well-being

The concept of a digital detox, involving a deliberate reduction or elimination of digital device usage, has emerged as a potential strategy to mitigate the adverse effects of technology on mental and physical well-being. However, the specific effects of a structured digital detox program on psychological distress, psychosocial factors, menopause symptoms, and overall physical health in a community context remain underexplored.

This study seeks to address this gap by conducting a real-world trial, examining the impact of a digital detox program tailored for women. By delving into the intricacies of how digital technology interacts with the unique challenges faced by women, this research aims to contribute valuable insights into the development of real-world-driven interventions that promote the holistic well-being of women in the digital age.

Excessive screen time and social media use during menopause pose multifaceted challenges. Prolonged exposure to screens can disrupt sleep patterns and exacerbate existing sleep disturbances, impacting the hormonal balance crucial for menopausal women. Social media's potential to induce stress, anxiety, and negative self-perception adds an emotional layer, while sedentary screen-related behavior may contribute to physical health concerns such as weight gain and decreased bone density, issues already pertinent to menopausal women. The impact on interpersonal relationships, cognitive function, body image, and time management further complicates the landscape, highlighting the need for mindful strategies to navigate the intersection of menopause and digital habits.

The World Digital Detox Program, developed by the Zep Foundation, takes a comprehensive approach to address challenges associated with increased screen and social media use, extending its focus to encompass the unique challenges faced by women during menopause. The concept of a digital detox, involving a deliberate reduction or elimination of digital device usage, has emerged as a potential strategy to mitigate the adverse effects of technology on mental and physical well-being.

The overarching aim is to enhance the comprehensive well-being of women in the digital era, going beyond addressing broad concerns of prolonged screen usage. The focus is on tailoring interventions to meet the distinct needs of women navigating the complexities of menopause. This involves incorporating practices such as breathwork, exercise, dietary adjustments, and overall well-being strategies, ensuring a holistic approach that considers the unique challenges and requirements of women during this life stage.

Eligibility Criteria:
Inclusion Criteria:

* Menopausal staging: perimenopause or postmenopausal as per STRAW definitions
* Speak, read, and write in English sufficiently to comprehend materials in group treatment.

Exclusion Criteria:

* Participants who are severely depressed
* Need for acute treatment
* Participants with Psychotic Disorders, or current Substance Dependence.
* On Hormonal Replacement Therapy or intent to in next 3-months
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned

To investigate the clinical effects of vilaprisan and ulipristal acetate at molecular and cellular level on uterine and fibroid tissue taken from patients (after surgery / biopsy)


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older and premenopausal (based on gynecological history i.e. still menstruating; no significant estrogen deficiency symptoms)
* Diagnosis of uterine fibroids documented by ultrasound and relevant symptoms reported by the patient (e.g. heavy menstrual bleeding, pelvic pressure)
* Patients for whom surgery (hysterectomy or myomectomy) for the treatment of symptomatic uterine fibroids is planned
* Patients who are otherwise healthy as shown by medical history, physical and gynecological examinations, and laboratory test results

Exclusion Criteria:

* Contraindications for the progesterone receptor modulators (PRM) vilaprisan or ulipristal acetate
* Use of medication that might interfere with the conduct of the study or the interpretation of the results (e.g. continuing use of hormonal contraceptives, tranexamic acid or other treatments for heavy menstrual bleeding, progesterone receptor modulators, gonadotropin-releasing hormone agonist, anticoagulants, moderate and strong CYP3A4 inducers and moderate and strong CYP3A4 inhibitors within a defined time period before treatment starts.
Search for Phenotype-modifying Genes in Patients With Intellectual Disabilities.

Each form of intellectual disability under study is a rare disease in its own right, and it is therefore difficult to study the variability of its expression. It therefore appears necessary to study large series of patients with intellectual disabilities. The objective is to identify variants in phenotype-modifying genes in patients with intellectual disability.

Thanks to the contribution of NGS analyses (exome and genome analysis), the rate of etiological diagnosis in intellectual disability is currently approaching 42% in some meta-analyses. At Bordeaux University Hospital, since 2017, 700 patients have been sequenced for intellectual disability, with a diagnostic rate of 33%.

In genetics, epistasis refers to the interaction between two or more genes. As part of its previous work, BIONOMEEX has developed an algorithm called GWAS-2D (genome wide association study 2 dimension) which makes it possible to observe, from a large number of samples and for a given phenotype, the relationships existing between two loci on the genome.

The GWAS-2DI project involves the reanalysis of exome sequencing data from patients with intellectual disabilities at Bordeaux University Hospital, using a GWAS-2D algorithm developed by BIONOMEEX to search for phenotype-modifying genes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Intellectual Disability or related but not affected by them
* Major or minor with autorisation of legal representative
* Exome sequencing in Bordeaux University Hospital between 2018 and 2024

Exclusion Criteria:

* Refusal to participate in research protocols
* Refusal to participate expressed following receipt of information letter.
Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation

Primary Objective:

- To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent Atrial Fibrillation (AF).

Secondary Objective:

* To assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected population.
* To document SR33589 and SR35021 trough plasma levels at steady state.

The study period per patient is approximatively 1 month broken down as follows:

* Screening period up to 7 days,
* Treatment period of 14 days,
* Follow-up period of 10 days.

Eligibility Criteria:
Inclusion criteria:

* Patients of aged 20 years or more.
* Permanent Atrial Fibrillation \[AF\] (defined as duration of AF \> 6 months) for which cardioversion is not considered and with resting ventricular heart rate ≥ 80 bpm at screening.

Exclusion criteria:

* Unstable angina pectoris.
* History of torsades de pointes.
* Prolonged QT corrected interval (≥ 500 ms).
* Third degree atrioventricular block (AVB) on the screening ECG while in AF or, documentation on previous ECGs while in sinus rhythm of PR-interval \> 0.28 sec or high degree AVB (2nd degree or higher) or, significant sinus node disease (documented pause ≥ 3 sec) - without a permanent pacemaker implanted.
* Congestive Heart Failure (CHF) of New York Heart Association classification (NYHA) class IV or recent (within 1 month prior to randomization) unstable NYHA class III.
* Treatment with other class I or III anti-arrhythmic drugs.
* Patients treated with amiodarone during the 4 weeks preceding randomization.
* Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic (in particular thyroid) or psychiatric disease.
* Hypokalemia and hypomagnesemia must be corrected before randomization.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy

Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of study having characterized the underlying mechanism of hypotension in this setting. New diagnostic methods are now available with high reliability to identify hypovolemia as the underlying cause of hypotension, among which change in cardiac index during passive leg raising may be the less affected by restrictive validity criteria. A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.

The aim of this study is then to identify, among hypotensive episodes occurring during renal replacement therapy in Intensive Care Unit patients, the percentage of episodes related to preload dependence as identified by passive leg raising.


Eligibility Criteria:
Inclusion Criteria:

* Intensive Care Unit patients with acute kidney injury
* under continuous renal replacement therapy initiated since less than 24 hours
* under hemodynamic monitoring by the PiCCO® device.

Exclusion Criteria:

* lower limb amputation
* inferior vena cava compression
* intracranial hypertension
* age below 18 year
* pregnancy
* advance directives to withhold or withdraw life sustaining treatment,
* lack of written informed consent by patient or next of kin
* lack of affiliation to social security as required by French regulation
* patient under a legal protective measure
* previous inclusion in current study
* inclusion in another research study
Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography

A single center, prospective clinical trial is planned to investigate the effect of different emergence angles of implant restorations on peri-implant soft tissue recession and implant marginal bone loss.

The primary outcome is to systematically evaluate the association of implant-, peri-implant tissue-, and restoration-related factors with facial mucosal level changes.

Facial mucosal recession still poses a threat to long-term success of implant therapy especially esthetic appearance. To study the timing and extent of mucosal recession and the associated risks, a prospective study is strategically important. This will allow the collection of valuable longitudinal data about facial mucosal level changes, peri-implant tissue dimensions, and implant/restoration parameters that are considered critical for determining the mucosal level. Forty adult patients who meet the inclusion criteria will be recruited to participate in this study. Patients that had an implant crown placed a minimum time frame of 6 months and have existing relevant clinical data (mucosal level and thickness, radiographs, cone beam computed tomogram (CBCT) scans, study casts and intra-oral photographs) at baseline and if possible at other follow-up visits will be invited to participate in this study. Patients that volunteer to be screened will not be examined for study eligibility until an informed consent has been obtained. Patient information will be protected according to HIPAA. The enrolled subjects will have research measurements taken, an ultrasound scan, intraoral photos and an impression of the arch including the study implant. One dental cone beam computed tomography (CBCT) scan will be taken to evaluate the implant position in relation to the alveolar ridge and to evaluate relative bone quality. The primary outcome will analyze the changes in the facial mucosal level, by superimposing the digital images of the stone models that were taken previously. On ultrasound images, peri-implant tissue parameters, implant positions, restoration contour, etc., will be measured and recorded. The primary outcome will then be equated with clinical and radiographic readings, and ultrasound parameters, along with timing of provisionalization or final restoration, in regression analysis to identify factors related to facial mucosal recession.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years old or older
* One immediate maxillary implant placement with 2 adjacent neighboring teeth
* Available pre-surgery model
* Radiographic documentation (either peri-apical x-rays or CBCT)
* Have final restoration for at least 6 months.

Exclusion Criteria:

* Are under 18 years of age.
* Are unwilling or unable to read and sign this informed consent document.
* Have any medical conditions that we believe may influence the outcome of the study.
Comparison of Recurrence Rate of 2 Herniotomy Techniques in Children Older Than 2 Years

the study is basically aimed at comparing two techniques of herniotomy by comparing there recurrence rates

in this study, the principal investigator will operate upon patients aged between 2 years and 12 years by two techniques. in technique called mitchell banks technique, inguinal canal will not be opened and in Fergusson gross technique, it will be opened

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients of either gender above age of 2 years and below 14 years of age presenting in pediatric surgery Mayo hospital lahore

Exclusion Criteria:

* sliding hernia strangulated hernia pts with connective tissue disorders pts with undesccended testis patients with hydrocele hernia with internal ring 2cm or more in size
Study of a Series of Patients Treated for Retrograde Cricopharyngeal Muscle Dysfunction Syndrome

R-CPD syndrome (Retrograde Cricopharyngeal Dysfunction syndrome) is an inability to burp.

It is a syndrome whose diagnosis is clinical, and for which there is effective treatment. Recently treated in the United States (first publication in 2019), this syndrome affects many patients in France and is currently unknown.

This study concerns a series of patients treated at the University Hospitals of Strasbourg for a syndrome of retrograde dysfunction of the cricopharyngeus muscle having been treated by injection of botulinum toxin into the cricopharyngeus muscle.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject treated by injection of botulinum toxin into the cricopharyngeal muscle after having had a diagnosis of R-CPD in consultation between January 1, 2022 and December 31, 2022
* Subject not opposing the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study,
* Subject under judicial protection
* Subject under guardianship or curatorship
Obesity and Obstructive Sleep Apnea (OSA) in Children

The goal of this research is to study the prevalence of sleep disordered breathing and associated morbidity in obese children and to examine the role of diet and physical activity in the treatment of sleep-disordered breathing in obese children.

In a prospective cohort study, obese children will be recruited. After informed consent is obtained, all children will complete a standardized sleep questionnaire and a pediatric daily sleepiness scale questionnaire. All participants will undergo a complete physical examination, blood tests for lipid profile, liver enzymes, and Glucose and insulin will be obtained, and liver sonography will be performed to assess for the presence of fatty liver. Nasopharyngeal radiographs will be used to assess adenoidal size based on the method by Cohen and Konak. A standard in-laboratory, overnight polysomnography will be performed, within 2 weeks of enrollment to the study, in the sleep laboratory at Asaf Harofeh Medical Center. Children with severe obstructive sleep apnea, defined as apnea hypopnea index (AHI) \> 15 will undergo adenotonsillectomy. All children will be referred for a dietary and physical education program. The first visit with the dietician will be considered day 1 of the study. Children will than be followed monthly by a dietician. After three months of follow-up, subjects will be divided into two groups. Group 1 will include all children who had AHI \> 2 on the initial polysomnography (including children who underwent adenotonsillectomy for AHI \> 15), and group 2 will consist of children who had AHI \< 2 on the initial PSG. Children of group 2 will continue monthly dietary visits as before. Children from group 1 will undergo a second evaluation including questionnaires, laboratory blood tests, liver sonography, nasopharyngeal radiographs, and polysomnography. Children who demonstrate reduction in the AHI based on PSG will be offered to continue with dietary treatment alone. Children with no change in the AHI based on PSG will be offered to undergo adenotonsillectomy in addition to continued dietary management. All children will be followed for a total duration of six months. After six months, all children will be re-evaluated by questionnaires, blood tests, liver sonography, and nasopharyngeal radiographs. Polysomnography will be performed in all children who had an AHI \> 2 on the second PSG.

Eligibility Criteria:
Inclusion Criteria:

* BMI at or above the 90th percentile

Exclusion Criteria:

* children with chronic lung or liver disease, mental retardation, syndromes (i.e. prader willi syndrome), endocrine abnormalities (hypothyroidism cushing), chronic medical treatment with oral steroids, or with anti-psychiatric or anti-convulsive medications
A Comparative, Retrospective Chart Review of Intended Dwell Time of a PICC Line

This is a retrospective, matched pair comparative post market review of 4Fr Single Lumen PICC lines. The subjects will be matched by the timeframe of when the HydroPICCs were inserted.

Subjects would have received a 4 Fr Single Lumen PICC line between Aug 2020 and Oct 2020.

The two groups will be HydroPICCs and the standard of care for the facility.

A comparison of multiple endpoints will be evaluated between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been inserted with the HydroPICC during a specific time range.
* During the same time period, any competitor 4 Fr single lumen placed.

Exclusion Criteria:

* None