cyrilzakka/clinical-trials huggingface dataset:
Preventing Invasive Cervical Cancer: The Importance of Expectant Management in Young Women With High-grade Pre-cancerous Lesions

Lesions classified as "High Grade Squamous Intra-epithelial Lesions" (HSIL) are pre-cervical lesions of the cervix, induced by infection with the Human Papilloma Virus (HPV). The detection and proper management of these lesions greatly reduces the incidence of invasive cervical cancer.

Pap smear remains the most effective tool for early detection of low and high-grade cervical lesions. In Belgium, screening for cervical cancer is recommended every 3 years for women between 25 and 65 years old.

HPV is a virus who possesses certain oncogenic genes who have the ability to inactivate tumor suppressor genes in the host cell. This promotes a tumorigenesis process within the tissues affected by the virus. The majority of human papillomavirus infections are transient and spontaneously cleared by host defense mechanisms, especially in the first two years after exposure. However, 10-20% of infections persist latently and may eventually lead to progression to invasive cervical cancer.

Even high-grade lesions kan naturally be cleared, even more so if the patient is young and immuno-competent. Therefore, the management of HSIL lesions in young women has been modified and consists of adopting mainly a conservative attitude, with controls every 6 months for 2 years. This management makes it possible to avoid unnecessary conizations of the cervix which, in young nulliparous patients, are not devoid of heavy obstetric consequences during subsequent pregnancies (premature birth, perinatal mortality). Cervical conization will only be considered for lesions that progress during follow-up or that persist beyond 2 years. However, this type of follow-up requires that patients be compliant.

Our study has two main objectives:

* to determine the compliance of CHU Brugmann Hospital patients who have been proposed a conservative strategy for the management of HSIL lesions.
* to identify the predictive factors for the persistence and / or progression of high-grade pre-cancerous dysplastic lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patients followed within the CHU Brugmann Hospital (no private practices).
* HSIL lesions confirmed by anatomopathologic analysis on cervical biopsies or cone specimen without evidence of invasive lesions

Exclusion Criteria:

* Invasive lesions
Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy

Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas).

In distal pancreatectomy, it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. This is considered essential to prevent disruption of the stump of the splenic vein and the consequent intra-abdominal haemorrhage in the event of pancreatic fistula. This procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of this trial is to confirm the non-inferiority of resection of the splenic vein embedded in the pancreatic parenchyma compared with the conventional technique of isolating the splenic vein before resection during distal pancreatectomy using a mechanical stapler.

Eligibility Criteria:
Inclusion Criteria:

* Elective open or laparoscopic distal pancreatectomy for diseases of the pancreatic body and tail
* ECOG Performance Status (PS) = 0-1
* Age ≥ 20 years old
* Maintenance of functioning of the major organs (bone marrow, liver, kidney, lung, etc.) (a) White blood cells ≥ 2,500/mm3 (b) Haemoglobin ≥ 9.0 g/dL (c) platelets ≥ 100,000/mm3 (d) Total bilirubin ≤ 2.0 mg/dL (e) Creatinine ≤ 2.0 mg/dL (v) Sufficient judgement to understand the study and to provide written informed consent

Exclusion Criteria:

* Splenic vein-preserving distal pancreatectomy
* Superior mesenteric vein or portal vein invasion
* Pancreatic trauma
* Preoperative inflammatory pancreatic disease (pancreatitis)
* Requirement of anti-coagulant treatment during or after surgery. Anti-coagulant treatment at 24 hrs after surgery is allowed.
* Severe ischemic cardiovascular disease
* Liver cirrhosis or active hepatitis
* Need for oxygen due to interstitial pneumonia or lung fibrosis
* Dialysis due to chronic renal failure
* Need for surrounding organ resection (stomach, colon, etc.), excluding the left adrenal gland and gall bladder
* Active multiple cancer that is thought to influence the occurrence of adverse events
* Difficulty with study participation due to psychotic disease or symptoms
* Inappropriate use of the stapler
* Inappropriate for the study objectives
Efficacy of a Face to Face Versus a Remote Physiotherapy Instruction Session About Pelvic Floor in Women With Urinary Incontinence

The purpose of this study is to assess and to compare the efficacy of a face to face versus a remote physiotherapy instruction session about pelvic floor muscle (PFM) function, including teaching women how to contract their PFM and how to perceive a correct PFM contraction. Study participants will be randomly assigned to participate in one of the three study groups: Group 1 will receive face to face instructions, Group 2 will receive real time remote instructions and Group 3 will not receive any instruction. The primary outcome measure is PFM function assessed using the modified Oxford Scale.


Eligibility Criteria:
Inclusion Criteria:

* Women who are not able to contract their PFM (≤ 2 of Modified Oxford Scale);
* Cognitive ability, hearing and visual acuity preserved (through 10-point cognitive screener and Snellen test, respectively);
* Non-neurogenic UI;
* No history of neurological disorders;
* No symptoms of a vaginal or urinary tract infection;
* Pelvic organ prolapse ≤2 (according to the Baden and Walker scale);
* Who have not already been instructed on how to perform PFM contraction or who is not already performing PFM training;
* No suspected or confirmed pregnancy.

Exclusion Criteria:

* Who have intolerance to physical examination, or latex allergy;
* Who withdraws from participating in the study.
Fludeoxyglucose F 18-PET/CT Scans in Patients Receiving Ultra Short-Term Dexamethasone For Lung Nodules

RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before and after steroid therapy may help doctors assess a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase I trial is studying fludeoxyglucose F 18 PET scan performed before and after ultra short-term dexamethasone therapy to see how well it measures changes in nodules in patients with lung nodules.

OBJECTIVES:

* To determine whether ultra short-term steroid therapy (24-48 hours) can be used to increase the accuracy of fludeoxyglucose F 18 positron emission tomography/computed tomography (FDG-PET/CT) imaging in categorizing nodules in patients with pulmonary nodules.
* To calculate the overall sensitivity and specificity of the nodules group, based on FDG uptake, for predicting malignancy.
* To gather effect-size estimates that will be used to improve the quality of a larger follow-up study.

OUTLINE: Patients receive oral dexamethasone at 40, 28, 16, and 4 hours before imaging. Patients undergo fludeoxyglucose F 18 (FDG)-positron emission tomography/computed tomography (PET/CT) imaging at baseline and upon completion of steroid therapy.

After completion of study therapy, patients are followed for 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Presence of ≥ 1 measurable pulmonary nodule (1.0-3.0 cm) suggestive of malignancy or chronic inflammatory process on positron emission tomography (PET) scan
* No lesions consistent with malignancy or inflammation according to history, PET findings, or biopsy
* Baseline scan average time between injection and start of scan within 50-70 min

  * Mean liver standardized uptake value (SUV) of baseline scan normal
  * No sign of significant partial paravenous tracer administration in the images of baseline scan
* No lung nodule(s) suggestive of lymphoma
* No lung lesions suggestive of tuberculosis

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Blood glucose levels ≤ 150 mg/100 mL
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Able to tolerate PET/CT imaging
* No history of diabetes
* No poorly controlled hypertension
* No prior malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma in situ, or other cancer from which the participant has been disease free for \< 3 years

  * No active malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

* More than 5 years since prior chemotherapy or radiotherapy
* No concurrent steroids
Penetration of Ceftaroline Into Cerebrospinal Fluid(CSF)

Ceftaroline is a piece of new cephalosporin very active on resistant staphylococci in methicillin (SEMR: Staphylococcus Epidermidis Resistant in Methicillin, SMAR: Staphylococcus Aureus Resistant in Methicillin)and/or in vancomycin ; Ceftaroline is also very active on pneumococci resistant in penicillin and/or 3rd generation of cephalosporins.

Ceftaroline was approved by the European Medicines Agency for the treatment of complicated skin and soft tissue infections and community-acquired pneumonia.

Scientific literature describes a good efficiency in septicemy and/or SAMR endocarditis.

Besides, a study on animal shows the efficiency of ceftaroline in meningeal infections with gram-negative Bacilli.

The rationale of this study is based on the antibacterial spectra of ceftaroline that could be used for the antibacterial treatment (curative and prophylactic) of CSF shunt associated infections.

To validate this hypothesis, it is necessary to evaluate the concentration of ceftaroline in meningeal compartment after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years)

  * Provision of informed consent prior to any study specific procedures
  * Female patients of childbearing potential may be entered if pregnancy testing is negative and the patient agrees to abstain from procreational sexual intercourse or must use double-barrier contraceptive measures for the duration of the study
* Presence of an indwelling external cerebrospinal fluid (CSF) access device (ventriculostomy or lumbar drain)
* Presence of inflamed meninges as a result of documented or suspected meningitis or ventriculitis. Patients with both clinical symptoms (fever, headache, meningismus, and altered mentation) and laboratory parameters (CSF leukocytosis, defined as a CSF white blood cell count \[WBC\] of \>10 3, elevated CSF protein, defined as CSF protein of \>1g/l, reduced CSF glucose, defined as CSF glucose of \<0.3g/l, or a positive CSF Gram stain or culture) indicative of CNS infection were deemed to have definitive bacterial meningitis/ventriculitis. Inflamed meninges were defined as the presence of \>5 leukocytes/mm3 of CSF.

Exclusion Criteria:

* Patient has documented history of hypersensitivity or allergic reaction (urticaria, angiooedema, anaphylaxis, desquamative rash) to any β-lactam antimicrobial including cephalosporins (contraindication to cephalosporins)
* Patient is pregnant or lactating and intends to continue breastfeeding
* Severe renal insufficiency defined as creatinine clearance \< 50 mL/min.
* Patients with conditions known or suspected to alter pharmacokinetics (i.e., burn or cystic fibrosis patients)
* Refusal to participate
* Person not affiliated with the social security
Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome

The use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due to its unique physical properties, such as low density and high carbon dioxide (CO2) diffusion coefficient. In previous studies in neonates with respiratory failure, conventional ventilation with heliox was associated with improved oxygenation and selected respiratory parameters. The use of heliox may increase the effectiveness of intermittent nasal positive pressure ventilation (NIPPV), but knowledge about the effects of such therapy on newborns is limited.The use of non- invasive neurally adjusted ventilatory assist (NIV-NAVA) allows synchronization and assessment of electrical activity of the diaphragm (EaDI) during heliox administration in premature babies with respiratory failure.

Aim of the study was to assess of the impact of non-invasive ventilation with heliox on respiratory function, diaphragm bioelectrical activity, cerebral oxygenation and selected vital signs in premature neonates with respiratory failure. 23 neonates ≤32 weeks gestational age (GA) were enrolled in the study. Patients were eligible for inclusion when ventilated due to respiratory failure, and in group 1 (n=12) on NIV as primary modality with oxygen requirement of 0.25-0.4 in the first 72 hours of life, or in group 2 (n=11) ready to extubate according to the given criteria. Newborns were ventilated with NIV NAVA and standard breathing gas (air-oxygen) at baseline. Heliox was introduced for 3 hours, followed by 3 hours of air-oxygen. NAVA level was kept constant and pulse oximeter oxygen saturation (SpO2) kept in range of 90-95%. Recorded parameters included heart rate (HR), SpO2 and cerebral tissue oxygenation (StO2). Selected ventilation parameters: peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), mean airway pressure (MAP), air leakage during NIV, fraction of inspired oxygen (FiO2) as well as electrical activity of the diaphragm (EaDI mean, minimum and maximum) were also acquired. Blood gas analysis was performed in each period of the study. Statistical analysis was completed with ANOVA Friedman's test and single-factor repeated-measures analysis of variance.

Eligibility Criteria:
Inclusion Criteria (Group 1):

* GA under 33 weeks GA
* Need for NIV due to clinical symptoms of respiratory distress in course of RDS
* FiO2=0.25-0.4
* Enrollment within first 72 hours of life
* Parental consent

Inclusion Criteria (Group 2):

* GA under 33 weeks GA
* Need for MV due to clinical symptoms of respiratory distress
* at least one failed attempted extubation
* Parental consent

Exclusion Criteria:

* Major congenital anomalies
* Deteriorating pulmonary function despite NIV and the need for intubation and conventional mechanical ventilation (CMV) (Preliminary criteria: pH\< 7.22, carbon dioxide partial pressure (pCO2) \>65)
Epidemiology of Venous Thromboembolism

To evaluate potentially modifiable lifestyle predictors of venous thromboembolism and their joint associations with biochemical and genetic determinants.

BACKGROUND:

Venous thromboembolism is a common condition with considerable morbidity and mortality. The disorder has diverse causes including trauma, stasis, drugs, cancer, and genetic factors that contribute to enhanced clotting and coagulation. The study uses existing large-scale population studies to unravel factors responsible for and contributing to venous thromboembolism.

DESIGN NARRATIVE:

The study design is a prospective cohort study of 77,118 persons based on pooling information from four large randomized trials of US health professionals that have collected detailed risk factor information and have used common strategies to prospectively identify and validate cases of venous thromboembolism (VTE). These trials are: Physicians' Health Studies I \& II including 29,071 US male physicians, of whom 22,071 have been followed since the initiation of the first trial in 1982; the Women's Health Study including 39,876 female health professionals who will have an average of 10 years of follow-up; and the Women's Antioxidant Cardiovascular Study including 8,171 female health professionals with prevalent cardiovascular disease or at high risk of cardiovascular disease who will have an average of 8 years of follow-up. Archived blood samples were collected from approximately 75 percent of participants at baseline and will be used to assess biochemical and genetic markers of risk including factor V Leiden, the G20210A mutation in the prothrombin gene, hyperhomocysteinemia, and anticardiolipin antibodies. The study will assess the joint association with risk of these markers and potentially modifiable factors including body mass index, hormone replacement therapy, physical activity, and aspirin use. The study population will include over 1,000 incident cases of VTE, including 750 with blood samples.

Eligibility Criteria:
No human subjects are involved. Collected data are used.
The Safety and Efficacy of RIC on Adult Moyamoya Disease

There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease( MMD) patients .Nowadays, revascularization is the only effective way for ischemic MMD and there is no effective conservative treatment for MMD. This study was to explore the safety and efficacy of remote ischemic conditioning(RIC ) on adult MMD patients.

There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease. Nowadays, revascularization is the only effective way for ischemic MMD while controversial for hemorrhagic MMD patients. Surgical complications including hyperperfusion syndrome, cerebral infarction or bleeding often occurred postoperatively. There is no effective conservative treatment for MMD up to now.

Remote ischemic conditioning is Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, and it has potential effects on preventing ischemia reperfusion injury and ischemic infarction.This study was to explore the safety and efficacy of remote ischemic conditioning on adult MMD patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-60 years
* All of the patients underwent digital subtraction angiography (DSA) and met the current diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.
* mRs≤3
* Informed consent obtained from patient or acceptable patient's surrogate.

Exclusion Criteria:

* Patients with acute ischemic or hemorrhagic stroke within 3 months.
* Severe hepatic or renal dysfunction.
* Severe hemostatic disorder or severe coagulation dysfunction.
* Severe cardiac diseases.
* Patients with severe existing neurological or psychiatric disease
* Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome , neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy.
* Patients have been done or plan to accept revascularization surgery.
In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Adults)

The investigational study product used in this clinical trial is a soft drink containing an arabinoxylan-oligosaccharides (AXOS) preparation extracted from wheat bran (hereafter called Wheat Bran Extract, WBE).

The objective of this study is to analyze the effect of the intake of two WBE doses on various parameters of gastrointestinal health. Additionally, safety was analyzed using treatment emergent Adverse Events (AEs) and clinical blood parameters.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-90 years of age, inclusive
* Regular eating habits
* Body Mass Index (BMI) between 18.5 and 30 kg/m2
* Consent to take in the study product according to the study protocol
* Subject is willing to maintain his or her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol)
* For female volunteers of childbearing potential: not planning to become pregnant during the clinical trial and willing to commit to the use of a medically approved form of contraception

Exclusion Criteria:

* Low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial
* Recent use of antibiotics
* Abdominal surgery in the past
* Serious illness within 3 months of start of clinical trial
* Use of medication or dietary supplements known to influence GI tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti diarrhea medication and/or probiotic medication
* Complete anesthetics within 1 month of the start of the clinical trial
* Chronic GI conditions such as inflammatory bowel disease (IBD), inflammatory bowel syndrome (IBS), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance
* Allergy for wheat products
* Celiac disease
* For female volunteers: pregnant or lactating
* Alcohol abuse
* Smoking more than 5 cigarettes per day
* Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk.
Results of Unicompartmental Knee Arthroplasties in Patients Beyond Historical Indications (PUCIL)

Primary objective:

To compare medial uni compartimental knee arthroplasty between patients who had a limit factor prior to the surgery ans patients who fill thé historical criteria.

Secondary objectives

1 to compare survival of medial UKA between patients with one limit factor and those with multiple limits.

2. To identify the prognosis factors of failure in medial UKA in our center during the time of our analysis (2009-2015)

7 year follow up survival if no amputation or no removal of UKA for TKA

Eligibility Criteria:
Inclusion Criteria:

- medial UKA implanted between 2009 and 2015 at the CCEG

Exclusion Criteria:

* no other UKA
* lost to follow up
* patient refuses
What is the Optimal Technique for Hydrodistention?

This research study is being done to learn what is the best way to perform hydrodistention. Eligible participants will be enrolled and have follow-up for three months after surgery.

The study team hypothesizes that changes in hydrodistention technique, including pressure, number of distention, and duration of distention, leads to no or minimal changes in symptom improvement for patients with Interstitial cystitis/bladder pain syndrome (IC/BPS).

Hydrodistention is a procedure designed to treat bladder and pelvic symptoms in patients with interstitial cystitis. A camera is placed inside the bladder and the bladder is filled with fluid. This procedure "resets" the signals between the bladder and brain, in order to reduce the symptoms of interstitial cystitis (such as bladder pain, urinary urgency/frequency/dysuria, incontinence, incomplete emptying, etc).

However, it is still unknown the best way to perform hydrodistention. Doctors do not know how much fluid to put in the bladder, how long to keep the fluid in the bladder, and how many times to fill the bladder.

Eligibility Criteria:
Inclusion Criteria:

* Patients with IC/BPS who have failed first/second line treatments (behavioral therapy, medications) for greater than 3 months
* Have not had hydrodistention performed in the past 3 months
* Have not had botox or Percutaneous tibial nerve stimulation (PTNS) performed in the past 3 months

Exclusion Criteria:

* Patients with known hunner's lesions
* Patients with interstim
* Patients with positive urinalysis/culture consistent with urinary tract infection (UTI)
* History of urethral, bladder, prostate, uterine, cervical, vaginal cancer
* History of augmentation cystoplasty or cystectomy
* History of urethral diverticulum, urethral stricture, pelvic radiation
* Patients with spinal cord injuries
* History of dementia, parkinson's disease, multiple sclerosis, spina bifida, paraplegia/quadriplegia, cerebral palsy, stroke
* Neurogenic bladder patients
* Anuric patients
* Tuberculous cystitis
* Cyclophosphamide treatment
* Pregnant patients