cyrilzakka/clinical-trials huggingface dataset:
Influence of Pesticide Exposure on the Occurrence of Hypospadias in Newborns in Picardie

We want to see if there is a relationship between exposure to pesticides and the occurrence of hypospade in Picard newborn .

Hypospadias is the most frequent malformation of the external genital organs in the male infant. Incomplete virilization of the genital bud results in hypoplasia of the tissues on the ventral aspect of the penis, with an ectopic ureteral meatus, a curved penile shaft and an incompletely formed foreskin. The condition is generally isolated and the aetiology is unknown. The pathogenesis is complex and involves hormonal, genetic and environmental factors (which are probably interlinked).

A doubling in the incidence of hypospadias over the last 15 years has emphasized the probable role of environment factors: in fact, certain exogenous compounds (collectively referred to as "endocrine disruptors" (EDs)) may modify hormonal functions and thus exert harmful effects on the organism or its offspring.

The male urethra develops between the 8th and 16th weeks of gestation in an androgen-dependence manner. In utero exposure of the foetus to EDs may have a physiopathological role in the abnormal development of the male genital bud and thus in the development of hypospadia. These EDs are present in many different substances, such as pesticides.

Many epidemiological studies have evidenced an increase in the incidence of hypospadias in children born to exposed parents. Furthermore, animal studies have identified a certain number of compounds associated with hypospadias after in utero exposure. However, human foetal samples have very rarely been assayed in an attempt to measure the true level of impregnation (i.e. the dose received). At present, it is not possible to draw firm conclusions with regard to the true extent of a link between EDs and the increased incidence of hypospadia.

The "HypoMeco" project is a prospective case-control study.

Eligibility Criteria:
Inclusion Criteria:

* male newborns
* born after February 1st, 2011, in a maternity hospital/clinic in the Picardie region

Exclusion Criteria:

* refusal to participate,
* severe associated disorders
* associated multiple malformation syndromes
* patients not attending the consultation.
* parents under the age of 18
* prison inmates
Aromatherapy Effect on Pain and Anxiety After C-section

A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023.

The aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women.


Eligibility Criteria:
Inclusion Criteria:

* All women who gave birth by cesarean section under spinal anesthesia in the obstetrics and gynecology department at the Ben Arous regional hospital who met the following criteria were included in this study:

  * Age between 18 and 45 years old
  * Term of pregnancy at the time of delivery ≥ 37 weeks of Gestation.
  * A minimum level of primary education as a prerequisite to answer the questions (in particular the STAI items).
  * Classified ASA 1 or 2 of the American Society of Anesthesiology (ASA) classification.
  * Having no history of cancer or chronic pain.
  * Free from any psychiatric pathology.
  * And having not presented any intra- or post-operative complications.

Exclusion Criteria:

The investigators excluded patients in our study:

* Having given birth to a stillborn or a suffering newborn requiring transfer to neonatal intensive care.
* Having received painkillers in the post-operative period.
* Having olfactory disorders.
* Having a substance abuse problem.
* Having a known allergy to lavender or other aromatic plants.
* who did not agree to participate in the study or who did not continue all stages of the trial.
Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET Confirmation

This pilot study will try to demonstrate metabolic changes in spine lesions treated by Augmentation and Ablation, according to existing standards of practice. Our purpose is to show the efficacy of a new radiofrequency radioablation (RFA) in combination with augmentation, using a percutaneous ablation device (Osteocool-Medtronic) in the treatment of secondary vertebral bone tumor, avoiding concurrent bias related to other treatments of the disease.

Only patient supposed to undergo percutaneous vertebral augmentation for secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled. Lesions to be treated must be metabolically active on PET-CT, performed during the last month. Patients will be informed and sign and inform consent. Patients will be treated with Augmentation and Ablation (Osteocool-Medtronic). Post treatment patients will be submitted to a new PET-CT in order to verify activity on treated site.

Eligibility Criteria:
Inclusion Criteria:

* only patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled.
* lesions to be treated must be metabolically active on PET-CT performed during the last month.
* Patients will be informed and sould sign an inform consent.
* post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.

Exclusion Criteria:

-
A Study of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Participants

The main purpose of the study is to assess the injection site pain intensity of two formulations using prefilled autoinjector device in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker
* BMI greater than (\>)18.5 and less than (\<) 30.0 kilograms per square meter (kg/m2)
* Body weight greater than or equal to (≥) 50.0 kg for males and ≥45.0 kg for females
* Are in good health, as determined by the investigator (or designee) to have no clinically significant findings from medical and surgical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations
* Are reliable and willing to make themselves available for the duration of the study, are willing to follow study procedures, and demonstrate the ability to self-inject

Exclusion Criteria:

* Are pregnant or breastfeeding
* Have a positive urine drug screen or alcohol breath test at screening Have participated in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing or concomitant participation in an investigational study involving no drug or device administration
* Have known allergic reactions to any components of mannitol or the placebo matrix or related compounds or history of significant atopy
* Have self-perceived dullness or loss of sensation on either side of the body or the abdomen
* Have tattoos or scars over the abdomen or other factors (e.g., rash, excessive folds of skin) that, in the Investigator's opinion, would interfere with injection site assessments
* Are currently using painkillers, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs). Intend to use prescription or over-the-counter medication for pain or inflammation within 7 days prior to the first injection
* Have any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study
An Investigational Scan (MRI With Dixon Based Sequences) in Detecting Prostate Cancer

This trial studies the use of magnetic resonance imaging (MRI) with Dixon based imaging sequences in detecting prostate cancer. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Researchers hope to learn if using a modified MRI scan technique with Dixon based imaging sequencing will help to produce better images of prostate cancer than the standard of care MRI scan technique.

PRIMARY OBJECTIVES:

I. Evaluate prospectively the accuracy of Dixon based sequences in detection of intraprostatic tumor nodules.

II. Determine the sensitivity, specificity, positive and negative predictive value of Dixon based sequences in assessment of extraprostatic tumor extension and lymph node involvement.

SECONDARY OBJECTIVES:

I. Compare the accuracy of Dixon based sequences versus multiparametric diffusion weighted imaging including diffusion tensor imaging in tumor detection and extraprostatic extension.

II. Compare the accuracy of Dixon based sequences in detection of transition zone tumors.

III. Determine the optimal scanning parameters for Dixon based sequences in the imaging of prostate adenocarcinoma.

OUTLINE:

Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate cancer patients who are scheduled to undergo prostatectomy.
* Patient who is scheduled to have a clinically indicated staging endorectal prostate MRI exam.
* Patients who have signed their informed consent form to undergo the study.

Exclusion Criteria:

* Known prior hormone ablation or radiation therapy (pelvic or prostate).
* Patients who do not want to undergo prostatectomy and prefer other therapy or surveillance.
* Contraindication to conventional MR imaging (e. g. metal implants, pace maker, etc.).
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection

The purpose of this study is to determine whether the oral administration of daily selenium supplements to HIV-1 positive pregnant women: enhances immune status and reduces the HIV-1 viral load at six months postpartum, reduces the risk of lower genital shedding of HIV-1 infected cells at 36 weeks of gestation, and reduces the risk of mastitis at six weeks postpartum, compared to placebo.

We are recruiting pregnant women who are infected with HIV and assign them to receive selenium or placebo. All women will be given standard prenatal care, including nevirapine for the prevention of mother-to-child transmission and prenatal multivitamin supplements. We will examine the effect of the selenium supplements on intermediate outcomes predictive of the risks of transmission of HIV and to disease progression.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 Infected women between 12 and 27 weeks of gestation

Exclusion Criteria:

* Women with clinical AIDS defined according to WHO Criteria
STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease

A multicentre trial on clinical effects of radiosurgical ablation of ventricular tachycardia (VT).

Patients with previously failed conventional RF catheter ablation will be randomized to radiosurgery (active treatment group) or repeated catheter ablation (control treatment group). Details on inclusion and exclusion criteria are provided below.

Randomization Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of structural heart disease (SHD), left ventricular (LV) ejection fraction, and serum B-type natriuretic peptide (NT-proBNP) level.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with structural heart disease (SHD) of any etiology (ischemic, non-ischemic, congenital corrected or uncorrected)
2. Implanted implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
3. Prior ≥1 catheter ablation procedure for VT due to SHD of them the last one performed in the expert center and employed:

   3.1 all meaningful mapping/ablation approaches (endocardial/epicardial access to left / right ventricular substrate as possible or appropriate) 3.2 precise electroanatomical mapping of the arrhythmogenic substrate in anticipation of future radiosurgery 3.3 additional mapping of structures used for precise image integration (aortic arch, left main ostium, right ventricular endocardial surface)
4. VT recurrence after the last catheter ablation fulfilling all criteria as follows:

   4.1 clinically relevant and requiring further intervention 4.2 compatible with the previously characterized arrhythmogenic substrate 4.3 occurred on stable antiarrhythmic medication (mostly amiodarone) unless contraindicated 4.4 reversible cause excluded
5. Signed an Institutional Review Board (IRB)-approved written informed consent

Exclusion Criteria:

1. Age \< 20 years
2. Acute coronary syndrome or recent percutaneous coronary intervention or cardiac surgery (\< 3 months)
3. Primary electrical disease (channelopathy)
4. Pregnancy or breastfeeding
5. Chronic heart failure with New York Heart Association (NYHA) Class IV
6. Serious comorbidities with presumed life expectancy less than one year
7. Significant peripheral artery disease precluding retrograde aortic mapping
Research to Evaluate Efficiency in U-health Solution Service for the Chronic Wound Management

This trial is a prospective research to evaluate efficiency in U-health solution service based on Mobile for the chronic wound management.

This trial conducted to assess the efficiency of teleconsultation using the smart-phone-based store-and-forward system in promoting the wound healing process as well as cost-effectiveness in patients with pressure ulcer.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have pressure ulcer
* Subjects who voluntarily decided the participation of the study and signed the informed consent

Exclusion Criteria:

* Subjects who have Osteomyelitis
* Subjects who have suppuration
* Subjects who participated in other clinical trial within 30 days from screening date
Cognitive Status After Removal of Skull Base Meningioma

The purpose of this prospectively enrolling trial is to assess long-term cognitive outcomes of patients undergoing surgery for resection of a meningioma associated with the frontal and temporal lobes.

This study will look at patients who are undergoing resection of a skull based meningioma, located in the frontal or temporal lobe, via craniotomy or via endoscopic endonasal approach. The study will compare cognitive function at baseline, at six weeks postoperatively and at one year postoperatively. The cognitive testing being done at baseline will be a clinical care set of assessments done by the speech language pathology team and will include the RBANS tests, the MoCA, PROMIS-29, and NeuroQOL-Cognitive Functions.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a meningioma associated with the frontal or temporal lobes
* Subject is scheduled to undergo open craniotomy or Endoscopic Endonasal surgery
* Subject is 18 years of age or older
* The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
* Previous surgery will not exclude the patient as a new baseline cognitive evaluation will occur.

Exclusion Criteria:

* Patient is a prisoner
* Patient is 90 years of age or older
* Pregnant women
* Previous radiation to the brain
Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines

This study aims to investigate the effect of 3 randomly applied interceptive measures (slow maxillary expansion, extraction of deciduous canines and no intervention) on maxillary canine impaction in patients with early mixed dentition and lack of space in the dental arch. Additionally, these groups are compared with a control group with adequate space. Patients with at least one impacted maxillary canine, presence of deciduous canines and absence of crossbite were included. The canine position is assessed by measuring five variables (sector of the canine cusp, canine to midline angle, canine to first premolar angle, canine cusp to midline distance, and canine cusp to maxillary plane distance) on 2 panoramic radiographs at 0 (T1) and 18 months (T2).

The detailed information regarding methodology has been entered in following sections

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting at the intake consultation of the Department of Orthodontics of University Hospitals Leuven, Belgium from September 2016, with at least one maxillary permanent canine impaction are invited to participate. Canine impaction is diagnosed based on a panoramic radiograph, taken for standard evaluation of dental development and associated pathology. A maxillary canine is considered to be impacted when the canine to midline angle was ≥15° (Alqerban et al. 2014; Warford et al. 2003). Only impacted maxillary canines with incomplete root formation and with persisting deciduous canines are included.

Exclusion Criteria:

* presence of uni- or bilateral posterior dental crossbite,
* upper permanent canines showing root malformation, ankylosis or fully erupted,
* evidence of root resorption of adjacent teeth, previous orthodontic treatment,
* craniofacial syndromes,
* systemic disease that would impede orthodontic treatment/surgery and recent exposure to radiotherapy.
* large eruption follicles seen on the permanent canines
Investigation of Mohs Surgical Margins Using Two Photon Microscopy

The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during Mohs surgery. The main question it aims to answer is:

• How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology

This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care frozen section analysis (FSA) for confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation using cryosectioned H\&E slides, thus all patients will receive standard of care confirmation following experimental imaging.

Individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using TPFM. Following imaging, specimens will be cryosectioned as per normal procedure. Following treatment, the results of the TPFM evaluation of each Mohs excisions will be compared to the results from FSA to assess the overall accuracy of TPFM and to determine if TPFM would result in changes to patient care if used without FSA confirmation.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing treatment for BCC with Mohs surgery at the performance site
* Able to read and understand consent form

Exclusion Criteria:

* None
Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture

Investigators will compare the clinical outcomes of femoral neck system with conventional multiple cannulated screw in non-displaced femoral neck fracture.

Clinical outcomes include reoperation, loss of fixation, and change of mobility.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* non-displaced femoral neck fracture
* community ambulator

Exclusion Criteria:

* younger than 18 years
* displaced femoral neck fracture
* intertrochanteric fracture
* subtrochanteric fracture
Examination of Virtual Supermarket (Vmall) as an Assessment of Executive Functions in Children and Adolescents With Acquired Brain Injury

The purpose of this research is to find whether or not there are differences in the executive functions during "shopping" in a "virtual mall", between children with Acquired Brain Injury (ABI) vs healthy children.

The hypothesis is that there will be differences in time (more time to shop) and mistakes (more mistakes during shopping), in the ABI group.


Eligibility Criteria:
Inclusion Criteria:

* children with ABI
* at least a year after injury
* who have been discharged from hospital and back home

Exclusion Criteria:

* children with learning disabilities former to injury
* visual disabilities or developmental disabilities
Autologous Fibrin Glues for Fistulas Closure

Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output enterocutaneous fistulas. However, there are only few studies that report autologous glue application in a larger patient group or clinical-controlled studies in this setting. The aim of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with conservative management without the use of adjuvant application of FG into the fistulous tract.

The sudden appearance of intestinal contents draining from an abdominal incision is an emotionally devastating experience for both patients and surgeons. An enterocutaneous fistulas (ECF) is an abnormal communication between the bowel lumen and skin, often associated with fluid and electrolyte abnormalities, malnutrition, and sepsis. It is reported that spontaneous fistula closure rates vary from 15% to 71% after conservative treatment with wound care, control of infection, and nutritional support. Sufficient time should be allotted for the ECF to heal with conservative treatment, which also results in long-term discomfort.

Adjuvant use of fibrin glue (FG) in the fistula tract may promote healing in low-output ECF. Containing high concentrations of human fibrinogen and thrombin, FG have been used extensively in many surgical fields as a biological adhesive system for tissue adhesion or hemostasis. Different types of FG are now employed: commercially produced and homemade autologous adhesives. Currently available FDA-approved commercial products such as Tisseel, Artiss (Baxter, Westlake Village, CA, USA), and Evicel (Johnson \& Johnson, Somerville, NJ, USA) are widely used in clinical applications. Risks of infection transmission, allergic reactions, and also the high cost, however, still make autologous FG attractive. Additionally, in comparison with other adhesives, autologous compounds have several advantages in terms of biocompatibility and biodegradation.

The aim of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with conservative management without the use of adjuvant application of FG into the fistulous tract.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* presence of one or more fistulas
* fistulas of low-output volume (\< 200ml/24h)

Exclusion Criteria:

* failure to meet inclusion criteria
* mental handicap
* extreme thinness
* fistulous tract length \< 2 cm
* fistulous tract diameter \> 1 cm
* entero-atmospheric fistulas
* Crohn's disease-related fistulas
* any conditions that might impede spontaneous closure of the fistula, such as complex tracts, associated abscesses, residual disease, foreign bodies or distal obstruction
* any conditions that might increase the risk of auto-transfusion, including hypertension, or diabetes; and acquired immune deficiency syndrome (AIDS)