cyrilzakka/clinical-trials huggingface dataset:
Could the Cerebral Oximetry be a Good Technology to Measure Placental Oxygenation?

To assess the potential of the cerebral oximeter to measure placental oxygenation

There is general agreement among experts to recommend the use of phenylephrine as first line therapy for the treatment of arterial hypotension induced by spinal anaesthesia during caesarean delivery. In some studies, there are trends toward a lower PaO2 values in the umbilical cord venous blood when the mother receive this vasopressor. These findings may be a result of the vasoconstrictor effect of phenylephrine on utero-placental vessels, and a subsequent increased oxygen extraction by the fetus. The possibility to extract more oxygen would provide a certain "safety margin" in the event of compromised utero-placental blood flow during normal pregnancy. However, this "safety margin" should not be taken for granted in cases where signs of fetal distress are present, and this situation might influence the choice of vasopressors.

It is well establish on a physiological basis that during labour, utero-placental blood flow is lower during the contractions. This lower blood flow could result in a lower saturation value measured by the cerebral oximeter.

Twenty patients in labour will be included in this study. Patients will be recruited in obstetric clinic during pregnancy. Based on the second trimester ultrasound, patients with anterior placenta will be included.

During labour, once a functional epidural is in place, an Invos oximeter will be install. Two sensors will be applied on the abdomen (one above the placenta and the other above the myometrium at a place without placenta). Two sensors will also be applied on the extremities (forearm and leg).Saturation values and timing of the contractions will be recorded for sixty minutes. Half of the recording will be done with an oxygen mask. Vitals signs will also be registered every five minutes.

Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant woman (ASA I or II)
* Term gestation ( \> 37 weeks)
* Normal pregnancy
* vaginal delivery
* obstetrical epidural in place
* anterior placenta

Exclusion Criteria:

* patient refusal
* Any contraindication to neuraxial anesthesia
* cesarean section
* multiple gestation
* placentation abnormalities
* anormal placental perfusion
* Placental Abruption
Self Drainage in Pediatric Cystic Fibrosis Patients

In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis diagnosis confirmed by 2 positive sudoriparous diagnostic tests
* Age : 7 to 17 years
* Capacity to expectorate
* Clinically stable
* Ability to pedal on a bike and to respect orders for physical session

Exclusion Criteria:

* Haemoptysis \> 50ml
* Permanent non-invasive ventilation
* Respiration or digestive evolutive clinical abnormality
* Exacerbation
A Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract Extraction

The purpose of this study is to compare the safety and efficacy of goniotomy performed with a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate glaucoma subjects who are also undergoing cataract extraction with phacoemulsification (Phaco) and posterior chamber intraocular lens (PCIOL) implant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open angle glaucoma (including pseudoexfoliation and pigmentary glaucoma)
* Diagnosis of mild to moderate glaucoma as defined by ICD-9 staging definitions 365.71 Mild/365.72 Moderate (including visual field defects and/or characteristic optic nerve abnormalities consistent with mild to moderate glaucoma)
* Planned removal of a visually significant cataract as determined by the Investigator (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction

Exclusion Criteria:

* Any glaucoma diagnosis other than those noted in inclusion criteria
Targeting Stress-Induced Alcohol Relapse Risk With Doxazosin XL

Participants (N=10/group) will consist of non-treatment seeking individuals with AUD.

Following informed consent and baseline screening, participants will partake in 3 stress induction sessions to assess their stress levels and cravings for alcohol. Participants will be randomized to receive either increasing doses of doxazosin XL (0, 4, and 8 mg) or placebo in a double-blind manner.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-5 criteria for AUD;
* Report excessive alcohol use as defined by CDC guidelines in the past month (\>7 drinks/week for woman, \>14 drinks/week for men, \>3 drinks/occasion for women\>4 drinks/occasion for men)3.

Exclusion Criteria:

* Physical dependence on alcohol assessed using the SCID and Clinical Institute Withdrawal Assessment for Alcohol (CIWAA)41.
* Presenting an Alcohol Use Disorders Inventory (AUDIT) score indicative of severe alcohol dependence (≥13 for women, ≥15 for men);
* Meeting criteria for substance use disorder on drugs other than alcohol and nicotine;
* Currently taking a prescribed psychoactive medication (e.g., atomoxetine for ADHD). In addition, exclusion for those individuals taking CYP3A4 inhibitors. Most participants will not be taking any concomitant medications (including over-the-counter supplements). For those who are taking an allowed medication, the study physician will determine if the medications are CYP3A4 inhibitors.
* Medical conditions contraindicating doxazosin XL pharmacotherapy (e.g., postural hypotension);
* Taking contraindicated medications such as blood pressure medications;
* Be pregnant, nursing, or planning on becoming pregnant during the course of the study;
* Have any other illness, condition, or use of medications, which in the opinion of the PI and/or admitting physician would preclude safe and/or successful completion of the study.
Clinical Trial: Effectiveness and Efficiency of Physical Exercise in Cancer Patients

AIM: To evaluate the effectiveness and efficiency of an innovative exercise program (EP) for patients during treatment for gastrointestinal tumors, breast and non small cells lung cancer, in terms of improved quality of life (QOL), fatigue and functional capacity respect the usual standard treatment (ST). DESIGN: Pragmatic randomized clinical trial in two parallel groups: EP and ST. SETTING: 7 Primary Health Centers (PHC) of the redIAPPISCIII, in coordination with oncology services. PARTICIPANTS: 250 patients with the above tumors, locally advanced or with metastatic disease, in adjuvant treatment, with Performance Status(PS) PS1-PS0. INTERVENTION: Both groups received standardized usual care. The EP group will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a second phase in community facilities during the remaining 10 months. MEASUREMENTS: The primary outcome measure is the change from baseline in the QOL+66 treatment, as measured by the specific questionnaire for patients with cancer EORTC QLQ-C-30 and Short Form(SF-36) overall. Secondary: fatigue (FACIT-F), radiological response, functional capacity (6 minutes walking and cardiopulmonary test), muscle strength and progression-free survival and overall. Predictors and confounders: age, sex, stage and tumor type, histology, treatment. ANALYSIS: We will compare between groups mean changes from baseline measurement of quality of life questionnaire (QOL) and other variables, on an intention to treat basis, using longitudinal mixed-effects models for repeated measures at 2, 6 and 12 months follow-up. Cost / effectiveness and cost / incremental utility associated to the program wil be estimated.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70 years
* Diagnosis of digestive system cancer , breast cancer or histologically confirmed NSCLC stage IV Physical Status (PS) 0 or 1.
* First-line chemotherapy treatment for each type of standard tumor
* Adequate renal, liver and blood function.

Exclusion Criteria:

* Brain metastases
* Risk of fracture (bone metastases)
* Unstable heart disease, uncontrolled BP Systolic Blood Pressure((SBP)\> 200 or Diastolic Blood Pressure (DBP)\> 110), heart failure (NYHA II or greater), constrictive pericarditis
* Other diseases at the discretion of the investigator to be a contraindication for physical exercise.
* Perform regular physical activity (150 minutes / week of moderate or vigorous 75)
French National Observatory of Percutaneous Mitral Commissurotomy

The aim of this study is to validate prospectively the predictive score of late results about a diverse population recruited in France and to evaluate the contribution in predicting the outcome of the PMC scanner to study the mitral calcium score and the location of the calcifications.

This is a multicenter prospective observational study conducted in French medico-surgical sites.

The Percutaneous Mitral Commissurotomy (PMC) is the standard treatment for Mitral stenosis (MS) in patients with rheumatic favorable characteristics. In Western countries the MS reaches older patients with less favorable characteristics, including the presence of mitral calcifications. Calcifications are a factor of poor outcome of the PMC. The scanner appears as a useful examination for their study but is not carried out systematically. The prediction of late results of the PMC is particularly important in patients with non-ideal characteristics which form a particularly heterogeneous population. A score of late results of the PMC on the wider western series was recently released but has not to date received external validation. In this score, prediction results was multifactorial, with a consideration of paramount clinical factors, but also a prognostic significance of mitral calcifications.

The validation of predictive score of late results of the PMC, with the analysis of calcifications, would better select patients who may best benefit from PMC and those for which the surgical management is preferred.

The aim of this study is to validate an external sample predictive score of the event-free survival in patients who have had a good immediate result of the PMC.

This study, purely observational, does not create any special procedure outside the patient's usual care.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* This will include all consecutive patients with rheumatic MS referred for PMC
* Patients who agreed to participate in the study, with signed consent

Exclusion Criteria:

* Contraindication to the PMC
* Contraindication to non injected scanner for centers performing a scanner
* Patient Refusal to participate in the study
Assessment of Coronary Endothelial Function in Diabetic Patients With Acute Coronary Syndrome Using 15O-water Positron Emission Tomography

Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function, especially in the coronary arteries, which are a factor of poor prognosis. Following acute coronary syndrome, the endothelial function abnormalities usually persist for several weeks before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor prognostic factor. Investigators assume that global abnormalities of endothelial function in patients with diabetes may be additive with segmental abnormalities in revascularized myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there is no published data showing any relationship between calcium score and endothelial function abnormalities in these patients. The investigators seek a relationship between calcium score and persistence of abnormalities of coronary endothelial function in these patients.

The main objective of this study was to compare coronary endothelial function by quantitative method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a first myocardial infarction, type 2 diabetic or non-diabetic treated by angioplasty in acute phase (TIMI 3)
* Myocardial viability test before discharge
* Age over 18 years
* Informed Consent dated and signed by the patient
* Written and spoken French
* Beneficiary of social security insurance

Exclusion Criteria:

* Hypertension\> 160/90 mmHg despite medical treatment
* Lack of effective revascularization in acute phase of myocardial infarction (TIMI grade \<3)
* Significant three-vessel coronary artery disease (\> 70% stenosis in the other two coronary arteries); occlusion of a coronary artery; schedule revascularization (percutaneous or surgical); left main coronary artery stenosis
* Previous history of myocardial infarction
* Mechanical complication (mitral regurgitation, ventricular septal rupture, left ventricular free wall rupture)
* Heart failure
* No myocardial viability test before discharge, for whatever reason
* Type 1 diabetes
* Pregnant and / or lactating
* Age under 18 years or guardianship
Nosocomial and Community Acquired Legionella Pneumophila Pneumonia.

Legionnaire's disease (LD) is a major cause of both community acquired and nosocomial pneumonia, with Legionella pneumophila serogroup A (Lp1) being the most virulent and the greatest cause of disease. Sample culture of low respiratory tract is considered the gold standard in the diagnosis of LD, however its sensitivity seems to be poor and its performance is technically demanding. The introduction of urinary antigen detection testing (LUA) brought a major advance in LD diagnosis, with upt to 95% of cases in Europe being diagnosed with this method. Despite the high sensitivity of LUA for Lp1, ranging from 80-90%, its negative predictive value is low in other serogroup than Lp1 and therefore, Legionella may be unrecognized as agent of pneumonia. Although underdiagnosed and underreported, LD represents the second most common cause of pneumonia requiring admission in intensive care unit (ICU). Average fatality rate of LD in Europe reaches 10%, but its mortality is considered to be even higher in nosocomial patients.

Despite the higher fatality rate in hospitalized LD patients, poor is the knowledge on the risk factors that could induce disease and that increase mortality in the hospitalized population affected by LD. In order to shed more light on this topic a cohort of patients diagnosed with LD in the last 3 years will be retrospectively examined.


Eligibility Criteria:
Inclusion Criteria:

All confirmed human cases of Legionnaires' disease diagnosed within the CHU Brugmann hospital within the last 3 years, from 01/01/2016 till 31/12/2018. A similar approach will be followed for the St Pierre and the UZ Brussel Hospitals.

Exclusion Criteria:

Pregnant women.
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation

Study Type

Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial.

Primary Study Objective

The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI.

Primary Outcome Measure

The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.

Follow-up

Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years or greater
* Preoperative diagnosis of PJI of the hip or knee per the 2018 Definition of Periprosthetic Hip and Knee Infection
* Chronic PJI (symptoms lasting at least 4 weeks) per Tsukayama et al.
* Medical clearance for surgery
* Physical and mental ability and willingness to comply with the protocol, including the ability to read and complete required forms, and willingness and ability to adhere to the scheduled follow-up visits and requirements of the protocol

Exclusion Criteria:

* Late acute hematogenous infection per Tsukayama et al.
* Patients for whom a two-stage exchange arthroplasty is not indicated
* Sepsis
* Previously failed single- or two-stage revision arthroplasty for PJI (aseptic revision, polyethylene liner exchange, and/or irrigation and debridement with component retention is allowed)
* Patients with PJI of more than one joint
* Patients on chronic antibiotic therapy (≥ 6 months duration)
* Patients who require therapeutic anticoagulation
* Patients on antiplatelet therapy for whom withholding antiplatelet therapy for any amount of time is contraindicated
* Patients with renal insufficiency/failure (serum creatinine ≥ 2.0 mg/dl)
* Patients with uncontrolled diabetes, defined as: hemoglobin A1C levels \> 8.0%
* Patients on immunosuppressive therapy, chemotherapy for malignant disease, or glucocorticoid therapy (e.g. prednisone ≥ 10 mg/day).
* Patients with immunodeficiency (e.g., splenectomy; sickle cell anemia; Stage 3 HIV; primary humoral, bone marrow, or other transplantation.)
* Anticipated or potential patient relocation that may interfere with follow-up examinations
* Allergy to vancomycin HCl or tobramycin sulfate (Note: prior history of Red Man's syndrome is not considered an allergy)
* Patients who are pregnant or planning to become pregnant
* Patients in whom negative pressure wound therapy is contraindicated
* Patients infected with pathogens that are not considered susceptible to vancomycin HCl or tobramycin sulfate, as per the Investigator's opinion
* Breastfeeding at screening visit
* Patients who are prisoners
* Participation in another clinical trial of another Investigational Drug or Investigational Device within the past 30 days
Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy

This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed invasive breast carcinoma
* Women who underwent mastectomy and breast reconstruction
* Good performance status (ECOG 0-1)

Exclusion Criteria:

* Recurrent breast cancer
* History of ipsilateral breast irradiation
Effectiveness of a Childbirth and Parenthood Preparation Education in Primigravidas

To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of 148 pregnant women are planned to be included in the study. Data will be collected with the 'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety Scale-Revision 2' and 'Fetal Health Anxiety Inventory. The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of four weeks (a month (each week, once a week in total four sessions)). It is thought that the results of the research will contribute to the welfare of pregnant women by reducing maternal health needs, pregnancy-related anxiety and fetal health anxiety levels.

To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of 148 pregnant women are planned to be included in the study. Data will be collected with the 'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety Scale-Revision 2' and 'Fetal Health Anxiety Inventory. The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of four weeks (a month (each week, once a week in total four sessions)). Within the scope of the "Childbirth and Parenthood Preparation training" program; Physiological and psychological changes in the mother during pregnancy, daily life during pregnancy, smoking, alcohol and substance use during pregnancy, exercise during pregnancy, nutrition and nutritional support during pregnancy, pregnancy follow-ups, routine examinations and immunization, common problems during pregnancy and suggestions for solutions, signs of danger during pregnancy and what to do, risky pregnancies, drug and human medicinal product management during pregnancy, labor process, drug-free methods for coping with labor pain, postpartum period and its characteristics, physiological changes in the mother after birth, psychological changes in puerperium, puerperal role and adaptation, postpartum behaviors , care of the newborn in the postpartum period, postpartum contraception methods will be explained. It is thought that the results of the research will contribute to the welfare of pregnant women by reducing maternal health needs, pregnancy-related anxiety and fetal health anxiety levels.

Eligibility Criteria:
Inclusion Criteria:

* Literate
* 18-40 years old
* Primigravida
* Those who volunteered to participate in the research
* Pregnant women who do not have communication and mental difficulties

Exclusion Criteria:

* Those who do not fill out the entire questionnaire
* Those with risky pregnancy
* Pregnant women with a previous history of psychiatric illness