cyrilzakka/clinical-trials huggingface dataset:
Bowel Preparation Before 3D Rectal Water Contrast Transvaginal Ultrasonography for Rectosigmoid Endometriosis

Three-dimensional (3D) rendering may be employed during transvaginal rectal water-contrast transvaginal ultrasonography (RWC-TVS) for detecting the presence and describe the characteristics of rectosigmoid endometriosis. This study aims to evaluate the impact of bowel preparation on the diagnostic parameters of 3D-RWC-TVS in women with suspicion of rectosigmoid endometriosis.

An accurate diagnosis of the presence, location and extent of the rectosigmoid endometriosis is of paramount importance for the clinicians in order to inform the patients on the potential surgical or medical treatments. It is well established that transvaginal ultrasonography is the first-line investigation in patients with suspicion of deep infiltrating endometriosis. An improvement in the performance of transvaginal ultrasonography in diagnosing rectosigmoid endometriosis may be obtained by using rectal water contrast during transvaginal ultrasonographic scan. In the last years, three-dimensional (3D) rendering has been employed during transvaginal ultrasound for benign gynecological diseases.

Eligibility Criteria:
Inclusion Criteria:

- pain and intestinal symptoms suggestive of rectosigmoid endometriosis

Exclusion Criteria:

* previous surgical diagnosis of intestinal endometriosis
* previous radiological diagnosis of intestinal endometriosis (based on Magnetic Resonance or double-contrast barium enema
* history of colorectal surgery (except appendectomy)
* contraindications to bowel preparation or computed colonography (such as non-- compliant patients and rectal malformations)
* previous bilateral ovariectomy
* psychiatric disorders
Neurodevelopmental Disorders in Youth With Criminal Behaviors

1. Describe the prevalence of neurodevelopmental disorders among youth with criminal behaviors
2. Explore the relationship between specific neurodevelopmental disorders and the rates and types of crime
3. Examine the roles of psychiatric comorbidities and sociodemographic factors in juvenile criminality


Eligibility Criteria:
Inclusion Criteria:

* Juvenile offender from The Juvenile Affairs Division of Taipei City Police Department

Exclusion Criteria:

* Not Juvenile offender
Parenting Concerns in Patients With Cystic Fibrosis (MucoPar)

The purpose of this study is to explore and collect the perceptions, expectations and needs of CF patients about parenting. This will be done in the context of several small groups of patients led by a psychologist who will ensure that all the participants express themselves; he will encourage them to develop their points of view, their divergences and their common points about what constitutes to be a parent.

The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations

Life expectancy has improved significantly in cystic fibrosis in recent years. From paediatric disease, it has become a disease of the adult, with the emergence of new issues, such as becoming a parent. Parent patients still face the risk of complications and death while their child is still young. However, there is very little data in the literature on parenting in cystic fibrosis.

Therefore, the purpose of this study is to explore and collect the perceptions, expectations and needs of CF patients and their spouses about parenting.

All patients with children, followed in 2 large adult CF centers, and their spouses will be invited to participate in a 6 to 10-person discussion group (focus group) led by a psychologist. He will ensure that all the participants express themselves and are encouraged to develop their points of view, their divergences and their common points about what constitutes to be a parent. The discussions will be recorded and transcribed.

Patients who cannot participate in groups (e.g. patients colonized with Burkholderia cepacia complex) but wish to be included in the study will benefit from an individual interview with the psychologist, also registered and transcribed. A thematic analysis will be carried out from the transcriptions of group contents. For individual interviews, phenomenological interpretative analysis (IPA) will be used. A synthesis of the two analyses will then be done.

The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations.

Eligibility Criteria:
Inclusion Criteria:

For patients

* Have cystic fibrosis
* Be a parent and raise or have raised at least one child
* Being followed in one of the two adult CF centers participating in the study

For CF patients' spouses

- Live with the CF patient participating in the study

For both CF patients and spouses

* Being an adult (at least 18 y.o.)
* Have a good level of French and good speaking skills

Exclusion Criteria:

* For both CF patients and spouses
* Psychiatric pathology (borderline state, bipolarity and other psychotic disorders)
* Serious somatic disease not related to cystic fibrosis
Estromineral Serena Plus and Symptomatic Menopause

Oestrogen hormone deficiency in menopause leads to symptoms of which hot flushes, night sweats, insomnia and mood changes are the most frequent and, ultimately, worsen the quality of life. The gradual decline of oestrogen from peri-menopause results in altered function of many neurotransmitters, such as dopamine, melatonin and neuropeptides including beta-endorphins, which modulate the function of the hypothalamus and are involved in body thermoregulation.

In post-menopause, dopaminergic activity is significantly reduced and stimulus of the D2 receptors is effective in relieving hot flushes and in reducing the accompanying psychological symptoms.

The use of hormone replacement therapy, which is generally prescribed in the case of moderate or severe symptoms, is limited due to real contraindications or simply the woman's refusal to take the therapy, despite the presence of symptoms requiring its use.

A food supplement, named Estromineral (E), based on natural ingredients such as isoflavones, the absorption of which is increased by the presence of Lactobacillus sporogenes, and Vitamin D3 and calcium, strengthening bone mineralization, has been found to be effective at reducing vasomotor symptoms.

To potentiate the effect of E on the most frequent symptoms in menopause, it was considered rational to add the extracts of magnolia, active on psycho-affective symptoms, and chaste tree, acting on both hot flushes and psychological symptoms and a new food supplement was developed: Estromineral Serena Plus (ESP).

Estromineral Serena Plus is an association of isoflavones with added Lactobacillus, chaste tree and magnolia, active on menopausal vasomotor symptoms and on psycho-affective symptoms.


Eligibility Criteria:
Inclusion Criteria:

* female menopausal age
* more than 5 hot flushes/day
* mood or sleep changes

Exclusion Criteria:

* hormone replacement therapy
Exploring Long-term Risks and STI Prevalence in Pre-Exposure Prophylaxis Users in Gironde, France

SAFER-PrEP investigates the long-term impact of Pre-Exposure Prophylaxis (PrEP) on risky sexual behaviors and Sexually Transmitted Infection (STI) prevalence among users in Aquitaine. The study aims to compare STI rates over the last three months between individuals on PrEP for over a year and those on PrEP for less than a year. This retrospective observational research offers insights into the evolving dynamics of sexual health practices, informing future PrEP prescriptions and enhancing preventive strategies.

Scientific Rationale: The SAFER-PrEP study stems from the imperative to comprehend the intricate interplay between Pre-Exposure Prophylaxis (PrEP) utilization and sexual health dynamics. Amidst the increasing adoption of PrEP for HIV prevention, concerns arise regarding potential behavioral shifts and heightened risks for Sexually Transmitted Infections (STIs). The comprehensive investigation into these phenomena seeks to provide nuanced insights into the long-term implications of PrEP, contributing valuable data to public health initiatives and refining prevention strategies in the face of evolving sexual health landscapes.

Procedure: Participants, comprising individuals on PrEP for over a year and those for less than a year, will be engaged through a observational approach. Data will be collected via self-administered questionnaires during routine consultations for PrEP renewal in various medical settings, including hospitals and private practices. This comprehensive strategy enables a nuanced exploration of sexual behaviors and STI prevalence.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years old;
* Participants using PrEP for at least 6 months ;
* French-speaking, without comprehension disorders ;
* being affiliated to health insurance ;
* Willing to participate and to sign informed consent.

Exclusion Criteria:

* Individuals with known HIV positivity;
Dissemination of the "Choisir de Maigrir?" Program

The Québec government launched in October 2006 an action plan (PAG) to reduce the prevalence of overweight and obesity among young people and adults by 2012. One of the five priorities of the PAG is to improve health services for individuals with weight-related issues. The development and implementation of sustainable weight-control strategies however remains a challenge, since weight loss is often regained by the majority of individuals over time. "Health-At-Every-Size" (HAES) interventions, which are mainly focusing on health rather that weight, have been proposed as an interesting alternative for individuals, mainly women, who are struggling with weight-related issues. Based on the HAES, "Choisir de maigrir?" (CdM?) program has been clearly identified by the PAG as one of the actions for improving health services and Quebec's government has already started a massive dissemination of the CdM? program in CSSS of Québec. In that context, it becomes imperative to rapidly assess the effectiveness and readiness of the program for a broad dissemination. The present research proposal falls directly within the scope of the PAG recommendation and the investigators general objective is to develop a population-based understanding of the effectiveness of the CdM? program in Quebec's CSSS by documenting the effects of the program on women's health in a natural setting.

The impact of "CdM?" will be assessed with each CSSS at three time points: at baseline (T=1), at the end of the intervention period (T=2), and at 1-y post-intervention (T=3). While data collection instructions and assessment materials will be provided by the research team, administration of the CdM? program will be totally under the responsibility of each CSSS, so that the program will occur outside of the research team control. Validated questionnaires will be used to assess nutritional profile, physical activity level, and psychosocial variables among the participants (N=168). Weight, height and waist circumference will also be measured for each participant. In order to ensure that our results are not due to the effect of time, women on a waiting list for CdM? program, will be recruited (N=84) for the short-term effect. All these data will be treated using sophisticated analyses strategies.

Eligibility Criteria:
Inclusion Criteria:

* Women
* 18 years old and over
* Seeking help for weight-related problems

Exclusion Criteria:

* Considering the natural setting of the present study and the fact that the program is occurring outside of the applicants' control, no stringent exclusion criteria will be determined.
Real-time Ultrasound Guided Labor Epidural Placement

Specific Aim: The purpose of this study is to determine if labor epidural placement using real-time (concurrent) ultrasound guided placement is superior to the conventional "standard" epidural technique without the use of ultrasound at Magee-Womens Hospital.

Hypothesis: Ultrasound guided labor epidural placement in real-time will decrease the traditional epidural failure rate from 5% to 1%.


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women of childbearing age (including children aged 14 years and above) who request epidural analgesia at Magee-Womens Hospital will be eligible to participate in the study.

Exclusion Criteria:

* Men will not be included.
Bosentan Use in Patients With Diabetic Nephropathy

There is little doubt of the necessity for further improvement in the prevention and therapy of end-stage renal disease. Despite the success of ARB in treating diabetic nephropathy, not all patients obtain satisfactory control of blood pressure, albuminuria and decline in renal function. Experimental data have provided us with a rationale for the potential added benefits of ET receptor blockade to the AII inhibition in diabetic renal protection. Considering the nephroprotective effect of bosentan in diabetic rats, clinical studies are warranted to assess whether ET receptor antagonism has additive renoprotective effects on top of AII inhibition.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 years of age with a body weight of ≥ 40 kg;
* For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using intrauterine devices (IUDs);
* Patients diagnosed Type 2 diabetes with overt nephropathy (urinary albumin excretion ≥ 300mg/24h);
* Patients on current treatment with angiotensin II receptor blockers for ≥ 3 months;
* Patients stable for at least 3 months prior to screening (no change in medications for diabetic nephropathy);
* Provide written informed consent;

Exclusion Criteria:

* Patients with a history of pulmonary chronic obstructive disease, cardiac failure or coronary artery disease;
* Patients with documented cancers, acute infections or chronic inflammatory diseases;
* Patients who are pregnant or breast-feeding;
* Patients with known hepatic disorders or AST and ∕or ALT upper than normal limit;
* Patients with hemoglobin or hematocrit that is ≥ 30% below the normal range (patients with secondary polycythemia are permitted);
* Patients with systolic blood pressure \< 110mm Hg;
* Patients with plasmatic albumin level \< 30g/L;
* Patients with a documented creatinine clearance ≤ 60ml/min;
* Patients on anticoagulants or anti-inflammatory drugs, including cyclooxygenase inhibitors, AINS, prednisone and immunosuppressive drugs, platelet aggregation inhibitors, except low dose aspirin, ACE inhibitors, antidiabetic agents (rosiglitazone, pioglitazone) and antioxidants (vitamin E)(except statins or low-dose aspirin ≤ 80mg/day);
* Patients on treatment or planned treatment with another investigational drug;
* Patients who are receiving an endothelin receptor antagonist, phosphodiesterase type 5 inhibitor, or with a prostanoid (excluding acute administration during a catheterization procedure to test vascular reactivity) within 2 months of inclusion;
* Patients who are receiving calcineurin-inhibitors (i.e., cyclosporine A and tacrolimus), fluconazole, glibenclamide (glyburide) at inclusion or are expected to receive any of these drugs during the study;
* Patients with a known hypersensitivity to bosentan or any of the excipients;
Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric

1. Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric.
2. Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric.
3. Pharmacokinetics after a single dose of Dexmedetomidine administered as a nasal spray in Pediatric.


Eligibility Criteria:
Inclusion Criteria:

* selective operation of inguinal hernia repair、orthopedics operation or general surgery operation in children
* aged 3-9 years
* ASA I - II
* enter the operating room by himself without parents
* normal liver and kidney function
* no history of anesthesia medication allergy.

Exclusion Criteria:

* allergic to dexmedetomidine, similar active ingredients or excipients
* G-6-PD deficiency
* a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on
* a history of use of alpha 2 receptor agonists or antagonists.
Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD). Collection of intensive PK data from Chinese population had been designed in the ianalumab Phase 3 studies of SjD CVAY736A2302 (NCT05349214) and lupus nephritis (LN) CVAY736K12301 (NCT05126277) on an optional basis. This study is conducted to provide supplementary Chinese PK data in addition to the intensive PK data from the two Phase 3 studies .

The study consists of the following periods:

* Screening Period: up to 4 weeks
* Treatment Period (Week 0 - Week 12) : 12 weeks
* Extended Treatment Period (after the completion of Week 12 - Week 52 (End of Treatment (EoT)) : 40 weeks

  \~ After completion of the 12-week treatment, participants will have the option to enter the Extended Treatment Period. If a participant does not enter the Extended Treatment Period, the EoT visit will be performed at the next planned visit following the completion of Week 12, followed by the Post-treatment Follow-up Period.
* Post-treatment Follow-up Period: at least 20 weeks and up to 2 years from the last dose of study treatment.

Eligibility Criteria:
Key Inclusion Criteria:

* Male and female patients 18 years to 70 years of age (inclusive)
* Body weight at least 35 kg and not more than 120 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2 at screening
* Diagnosed with SjD and/or SLE as determined by the investigator
* Have active disease (SjD and/or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator.
* Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment

Key Exclusion Criteria:

* Use of prohibited therapies
* Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection
* Receipt of live/attenuated vaccine within a 4-week period before first dosing
* Uncontrolled co-existing serious disease
* Pregnant or nursing (lactating) women
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug

Other protocol-defined inclusion/exclusion criteria may apply.
Changes in Cerebral Oxygenation During Laparoscopy in Patients With Single Ventricle Anatomy

Patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid atresia) frequently have feeding difficulties necessitating procedures such as Nissen fundoplication and G-tube placement. With advances in minimally invasive surgery, these are frequently performed using laparoscopic techniques. Although generally safe and effective, the increase in IAP during laparoscopy may increase systemic and pulmonary vascular resistance and decrease cardiac output. This prospective study will include 50 patients with single ventricle physiology presenting for laparoscopic procedures. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).


Eligibility Criteria:
Inclusion Criteria:

* Patients with single ventricle physiology presenting for laparoscopic procedures.

Exclusion Criteria:

* None
Study of Blood Samples in Patients With Breast Cancer

RATIONALE: Studying the genes expressed in samples of blood from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to chemotherapy.

PURPOSE: This clinical trial is studying blood samples in patients with breast cancer.

OBJECTIVES:

* Identify constitutional gene variants associated with a change in response.

OUTLINE: Blood samples are collected periodically for analysis of genetic factors.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast carcinoma
* Received first-line chemotherapy (in neoadjuvant or metastatic setting) comprising anthracyclines and/or taxanes, including for a second primary cancer
* Patient agrees to conservative surgery
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* No contraindication for chemotherapy comprising anthracyclines and/or taxanes

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior adjuvant therapy
Intralesional Treatment of Plantar Wart

Group 1; intralesional injection of bleomycin in plantar wart. Group 2; intralesional injection of 5-fluorouracil in plantar wart


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be considered for participation in this study.

1. Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
2. Male or female ≥ 8 years old.
3. Subject has a clinical diagnosis of common warts.
4. Subject has up to 1 Target Wart and up to 3 additional Non-Target Warts located on the trunk or extremities. The identified Target and Non-Target Warts must meet the requirements as defined below:

   1. Each wart must have a longest axis that is ≥ 3mm and ≤ 8 mm and have a thickness of ≤3mm
   2. Each wart must be a discrete lesion
   3. Each wart must be present for at least 4 weeks
   4. Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
   5. Not be in an intertriginous fold
   6. Be the only common wart present when the circular cutout template is centered over the wart
5. The Target and Non-Target Warts must have a PWA ≥ 2.
6. Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
7. Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
8. Subject is non-pregnant and non-lactating.
9. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target or Non-Target Warts or which exposes the subject to an unacceptable risk by study participation.
10. Subject is willing and able to follow all study instructions and to attend all study visits.

Exclusion Criteria:

Subjects are excluded from this study if any 1 or more of the following criteria is met:

1. Subject has clinically atypical warts on the trunk or extremities.
2. Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant