cyrilzakka/clinical-trials huggingface dataset:
Long-term Outcomes of Patients Treated for Bladder Exstrophy by Questionnaires.

The bladder exstrophy epispadias complex (BEEC) is a rare spectrum of congenital conditions due to abnormal development of the cloacal membrane. Of these conditions, bladder exstrophy (BE) represent a mild form and requires several complex surgical corrections to gain access to a urinary and fecal acceptable continence and a normal sexual function at adulthood. Despite the surgeries, patients may suffer, in the long term, from functional impairments (incontinence, sexuality disorders) which can impact severely their quality of life. However, only a few studies investigate long term issues of bladder exstrophy patients, with heterogenous population and small samples.

The department of pediatric surgery of the Hospices Civils of Lyon is an expert center in the management of patients born with bladder exstrophy. At adulthood, departments of adult urology continue the follow-up and treat residual complications. Thus, a large cohort of adults and adolescents' patients with bladder exstrophy is currently followed at our institution.

Therefore, the aim of this study is to evaluate urinary continence, fecal continence, sexuality and quality of life among a large cohort of patients treated for bladder exstrophy, using questionnaires.

All patients over 15 years old and treated for bladder exstrophy at our institution are included in the study. Exclusion's criteria are : patients treated for epispadias or cloacal exstrophy, patients initially treated of their bladder exstrophy abroad with no access to the surgical report, patients under a guardianship measure. All included patients are contacted by e-mail or phone to answer the questionnaire. The purpose of statistical analysis is to evaluate the average score in each field of investigation:

* Mean ICIQ score for urinary continence
* Mean FLQI score for fecal continence
* Mean FSFI score for sexuality in women
* Mean IIEF-5 score for sexuality in men
* Mean SF-12 score for quality of life, in comparison of mean SF-12 score in general French population based on literature

Secondary objectives are to assess the impact of different surgical strategies used for bladder exstrophy reparation on urinary continence, fecal continence, sexuality and quality of life ; to describe the population from a sociological point of view (level of study, profession, marital status) and to describe the population reproductive status (pregnancy, delivery modalities, paternity and maternity status, use of medically assisted procreation).


Eligibility Criteria:
Inclusion Criteria:

* Patients born with bladder exstrophy or cloacal exstrophy
* Aged 15 and over at time of enrolment
* Treated at the Hospices Civils of Lyon

Exclusion Criteria:

* patients treated for epispadias
* patients initially treated of their bladder exstrophy abroad with no access to the surgical report
* patients under a guardianship measure
* deceased patients
US Time-Harmonic Elastography for the Early Detection of Childhood Glomerulonephritis

US Time-Harmonic Elastography for the Early Detection of Childhood Glomerulonephritis

Glomerulonephritis (GN) comprises a group of renal diseases characterized by glomerular and tubulointerstitial fibrosis secondary to glomerular inflammation and proliferation of the basement membrane, mesangial cells, or capillary endothelium triggered by immunologic mechanisms.(1) The glomerular filtration rate decreases with progression of chronic kidney disease (CKD), ultimately resulting in end-stage renal failure. Glomerulonephritis is the third most common cause of end-stage renal failure. Initial clinical signs of glomerulonephritis are nonspecific and subtle. Occasionally, affected patients present with hypertension, proteinuria, hematuria, raised serum creatinine level, weight gain, edema, or nephrotic syndrome.(2) The underlying pathologic changes are partly irreversible, and a prompt diagnosis with early initiation of treatment is of vital importance. The diagnosis is based on clinical, laboratory, and conventional US findings, whereas renal biopsy is considered the reference standard for a definitive diagnosis and fibrosis grading.(3,4) Unfortunately, this invasive procedure is associated with the risk of serious bleeding complications and therefore is not the method of choice for longitudinal monitoring.

Elastography, a Novel imaging modality that estimates tissue stiffness, especially for superficial organs such as the breast and Thyroid. In recent years, ultrasound elastography (UE) has been demonstrated in the liver and has been applied widely in the diagnosis and evaluation of liver diseases, such as chronic hepatitis, alcoholic liver diseases, and non alcoholic fatty liver diseases.(5,6) To date, renal allograft stiffness (elasticity) has been evaluated by magnetic resonance elastography (MRE) and ultrasound elastography (UE). However, UE application for native renal diseases has not been well up till now.(7) Conventional renal ultrasonography may be appropriate to evaluate kidney size, as well as to assess the echogenicity of the renal cortex, exclude obstruction, and determine the extent of fibrosis. However, It has no significant role in diagnosis of GN. US time-harmonic elastography depicts abnormal renal stiffness in glomerulonephritis, particularly among patients with early disease and preserved renal function.(8,9,10)

Eligibility Criteria:
Inclusion Criteria:

1. Age 1 month up to 18 years
2. Patientswith acute glomerulonephritis either poststreptococcal , lupus, ANCA related, or Ig A nephritis . Diagnosis of such diseases will be done through usual clinical, laboratory , radiological and histopathological data

Exclusion Criteria:

patients with clinical, laboratory , or radiological evidence of chronic kidney disease
CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema

To evaluate whether bilevel positive airway pressure more rapidly improves ventilation than continuous positive airway pressure (CPAP) in patients with acute pulmonary edema. CPAP is delivered via a simple device connected to oxygen.


Eligibility Criteria:
Inclusion Criteria:

* age \> 16 yrs, acute onset of severe respiratory distress, bilateral rales and typical findings of congestion on chest radiograph
* breathing frequency of \> 30/min, SpO2 \>90%, use of accessory respiratory muscles
Influence of Audiovisual Aids in the Preanesthetic Interview

1000 patients will be asked to fill out a questionnaire about preanesthetic visit right after the interview. On a daily randomization the Groups will be assigned to: Group A = face-to-face interview; Group B = interview plus brochure, Group C= interview plus movie.

Evaluation of patient satisfaction und knowledge transfer will be evaluated with a questionnaire filled out right after the interview with the anesthesist.


Eligibility Criteria:
Inclusion Criteria:

* voluntary

Exclusion Criteria:

* language Problems
* not able to read or write
* patients does not want to fill out questionnaire
PTNS on Urinary and Global Quality of Life in MS Patients

This is a single-centered, prospective, longitudinal, observational cohort study of patients with MS who suffer from lower urinary tract symptoms (LUTS) and are refractory to two prior treatment modalities who have elected to pursue PTNS therapy for LUTS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis
* Lower urinary tract symptoms (urinary frequency, urgency and/or incontinence)
* Failed prior first and second line therapy (behavioral and pharmacotherapy)
* Electing for Posterior Tibial Nerve Stimulation therapy for urinary symptoms
* Patients performing Intermittent Catheterization are Eligible

Exclusion Criteria:

* Indwelling catheters (urethral or suprapubic)
* Currently pregnant or planning pregnancy
* Unable to attend weekly office visits for PTNS
* Urodynamic findings of bladder outlet obstruction

History of:

bladder reconstruction (augmentation cystoplasty, catheterizable channel) cystectomy bladder stones pacemaker or defibrillator malignancy of bladder sacral neuromodulation intravesical injection of onabotulinum toxin within 9 months
The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome

The study try to investigate the possible effects of exercise and probiotics supplementation on dysmenorrhea amelioration from the perspective of microbiome.

In current study, there were two stages designed for current study. The definition of dysmenorrhea population depended on the Visual Analogue Scale (VAS) of McGill Pain Questionnaire (more than 5) and the VAS score less than 2 was considered as non-dysmenorrhea population.

In the first stage, the 20 subjects were recruit for non-dysmenorrhea group (Control group) and other 60 subjects were randomly allocated into three group with original lifestyle, aerobic, and resistant exercise intervention (Dys-Control, Dys-Aerobic, and Dys-resistant groups). The questionnaires (Premenstrual syndrome, the Menstrual Distress, and McGill Pain), body composition, physical fitness, biochemistries, inflammation, hormones and microbiome analysis (feces and tampon) were evaluated and assessed before and after 10-weeks indicated exercise training.

In the second stage, one hundred subjects (20 non-dysmenorrhea and 80 dysmenorrhea populations) will be recruited and the dysmenorrhea will be randomly allocated into Dys-Control, Dys-probiotics, Dys-exercise and Dys-probiotics and exercise groups. The questionnaires (Premenstrual syndrome, the Menstrual Distress, and McGill Pain), body composition, physical fitness, biochemistries, inflammation, hormones and microbiome analysis (feces and tampon) were evaluated and assessed before and after 10-weeks indicated interventions (probiotics and exercise).

Eligibility Criteria:
Inclusion Criteria:

* Primary dysmenorrhea
* Visual Analog Score of McGill pain questionnaire (0-2 for non-dysmenorrhea; \>5 for dysmenorrhea)

Exclusion Criteria:

* Pregnancy, menstrual disorders, obesity (BMI\>30), smoking, and alcohol or drug addiction
* Cardiovascular disease, hypertension, diabetes, asthma, chronic pulmonary obstruction, mental illness
Low Back Pain Among Care-seeking Families in General Practice

Background Low back pain (LBP) is the largest cause of years lived with disability worldwide and often associated with low quality of life, inability to work and low physical activity levels. In Danish general practice, LBP accounts for nearly 10% of all yearly consultations, making it the number one reason for consulting a general practitioner in Denmark. An increase in care-seeking children and adolescents with LBP in general practice is seen in the pre-teen-age-years.

At present, no study has investigated on the natural prognosis of LBP among care-seeking adolescents in general practice. Furthermore, the potential impact of patient and parent-related factors on prognosis remains unknown. The aims of the study are to 1) investigate the natural prognosis of LBP and 2) identify patient and parent-related factors which my influence prognosis.

Methods Adolescents aged 8 to 19 years consulting their general practitioner due to LBP will be invited to participate in this prospective cohort study. One parent of each patient will be invited to be a part of the parallel cohort. Online questionnaires will be used to collect data on patient characterises, pain intensity, pain frequency, medication, health-related quality of life, physical activity and illness perception at baseline and at the one-year follow-up. Data on pain intensity and parent-related worries will be collected through biweekly text messages. LBP will be assessed by latent class analysis.

Discussion This study will be the first to uncover the natural prognosis of LBP within a young, care-seeking population in general practice and to investigate if factors related to the patient or parents influence prognosis.


Eligibility Criteria:
Inclusion Criteria:

For adolescents in the primary cohort:

* age between 8 and 19
* experiencing low back pain

For parents in the parallel cohort:

- parent or legal guardian of included adolescents

Exclusion Criteria:

- not providing informed consent.
Restricted or Liberal Fluid for Haemodynamic Resuscitation in Sepsis

A prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.

This study is a prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.

The investigators will include four multicentre, open-label, randomised, clinical trials:

* Australasian Resuscitation in Sepsis Evaluation Fluids of Vasopressors in Emergency Department Sepsis (ARISE FLUIDS) trial conducted in Australia and New Zealand. ClinicalTrials.gov identifier NCT04569942
* Conservative versus Liberal Approach to fluid therapy of Septic Shock in intensive Care (CLASSIC) trial conducted in seven European countries. ClinicalTrials.gov identifier NCT03668236
* Crystalloid Liberal or Vasopressors Early (CLOVERS) trial conducted in the United States. ClinicalTrials.gov identifier NCT03434028
* Early Vasopressors in Sepsis (EVIS) trial conducted in the United Kingdom. ClinicalTrials.gov identifier NCT05179499

All four trials have all received relevant approval from a research ethics committee with a locally appropriate method of obtaining consent. These trials are prospectively chosen prior to the results of any individual trial being known because they are investigating the same broad question in patients with acute septic shock across several countries. The investigators of these trials collaborated to harmonise data and outcomes as far as possible across all trials to facilitate an IPDMA.

The aims to provide high level evidence to address the question of whether a fluid sparing/early vasopressor approach or a liberal fluid/later vasopressor approach to initial haemodynamic resuscitation in septic shock results in improved outcomes, including mortality.

Eligibility Criteria:
Inclusion Criteria:

Participants of the ARISE FLUIDS, CLASSIC, CLOVERS \& EVIS trials who had:

* Suspected or proven infection
* Systolic blood pressure (SBP) \<100 mm Hg OR mean arterial pressure (MAP) \<65 mm Hg
* Lactate ≥ 2.0 mmol/L
* Requirement for vasopressors to meet perfusion targets

Exclusion criteria:

Participants not in the ARISE FLUIDS, CLASSIC, CLOVERS \& EVIS trials
Effect of Vitamin D Supplementation on Fasting Glucose and Interleukin-10 (IL-10) in Arab Women With Impaired Fasting Glucose

Obesity, and its metabolic consequences - impaired fasting glucose (IFG) and diabetes, is highly prevalent among Arab women in Israel and the Middle East. Since life style modification is difficult to achieve in this population it is important to assess whether other modifiable risk factors can be detected. There is evidence that the homeostasis of vitamin D has a significant role in the eventual development of diabetes. Previous cross sectional studies have shown that low 25 (OH) vitamin D levels are related to glucose intolerance, diabetes, insulin resistance and metabolic syndrome. The study hypothesis is that 25(OH) vitamin D deficiency is highly prevalent among Arab women with IFG and that vitamin D supplementation may improve IFG and by that reduce the risk for future overt diabetes. Additionally, obesity is associated with a low-grade inflammation of white adipose tissue (WAT) resulting from chronic activation of the innate immune system. In obesity, there is an increased production and secretion of a wide range of inflammatory molecules including interleukin-10 (IL-10), which may have systemic effects on WAT and other organs. To that end the investigators will assess the influence of vitamin D supplementation on IL-10 and hs-CRP.

Eligible women will be invited by their primary care physician to participate in the study. After signing an informed consent women will be randomized to receive oral vitamin D 100,000 IU or similar placebo once a month for three consecutive months. Pertinent clinical and demographic date will be documented and relevant laboratory test will be performed by the primary care team. One month after the third dose the same data and tests will be retrieved on each woman. Compliance with the study protocol will be enhanced and confirmed by a research assistant.

Objectives:

To assess the relationship between IFG and 25(OH) vitamin D levels in overweight Arab women.

To assess whether vitamin D supplementation significantly improves IFG. To assess whether vitamin D supplementation significantly modifies IL-10 and hs-CRP.

Eligibility Criteria:
Inclusion Criteria:

* Arab women, age 40-65
* No significant handicap or disabilities in ADL
* BMI \> 25 kg/m2
* IFG of 100-125 mg/dl

Exclusion Criteria:

* Diabetes Mellitus
* Other medical conditions that may have an effect on IFG (cancer, chronic renal failure, inflammatory diseases etc)
* History of vascular disease
* Regular use of medications that may affect IFG (steroids, HRT, diuretics etc)
* Hypercalcemia (albumin corrected Ca \>10.3 mg/dl)
* Inability to sign an informed consent due to mental or psychiatric ailment
Effects of Lactobacillus Reuteri in Premature Infants

This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.

The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.

The primary outcome "days to achieve full feeds" will be measure during the the first month of life Secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, once intervention discontinued and at 6 months of live

Eligibility Criteria:
Inclusion Criteria:

* Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days

Exclusion Criteria:

* Chromosomal anomalies.
* Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
* Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
* Parental refusal
* Prior enrollment into a conflicting clinical trial
Third Ventriculostomy Versus Shunt for Children With Hydrocephalus

Ventriculoperitoneal shunts are the standard of care for patients with communicating hydrocephalus, but they have a high failure rate - up to 40% fail within 1 year and 50% fail within 2 years. It has long been assumed that endoscopic third ventriculostomy (ETV) would not work in this population and is better suited to patients with obstructive hydrocephalus (such as from a tumor blocking cerebral-spinal fluid (CSF) pathways). However, as scientists learn more about CSF and the way our brains absorb this fluid, they have learned that this may not be so straight-forward. Recent small studies have shown that ETVs can work in a good percentage of children with communicating hydrocephalus, too. But no randomized controlled trials have been done to compare these two treatments directly to determine which will provide children with a better prognosis, fewer surgeries over their lifetime, less time in the hospital and the greatest chance at as normal a life as possible.

The investigators will conduct a trial to compare these two surgical treatments where patients will be randomized to receive either a shunt or an ETV. Because ETV has been shown to have a high failure rate in newborns, the investigators will not include these patients and instead will study patients who come to Duke University with communicating hydrocephalus between the ages of 1 year and 18 years. The study will include patients with ventricular shunts who are in need of revision and patients who were just diagnosed and need their first shunt.

All patients who agree to participate will be randomized to receive either an ETV or a shunt. The study team will follow them for one year from the time of the surgery and will determine what percentage of patients require further CSF-related surgeries, how long they go after their surgery before they need another surgery, how much time they spend in the hospital and what percentage of patients suffer CSF-infections or other problems related to the surgery or their hydrocephalus. The study team will examine these results and determine if ETV is a safer or more effective treatment for children with communicating hydrocephalus than is a ventricular shunt.


Eligibility Criteria:
Inclusion Criteria:

* Children age 1-18 years
* Patients with communicating hydrocephalus who present in need of CSF diversion surgery, as diagnosed by radiographic imaging (CT or MRI of brain) as well as clinical signs or symptoms of increased intracranial pressure
* Informed consent according to institutional guidelines must be obtained from each patient's parent or legal guardian, or by the patient him/herself if he/she is 18 years of age

Exclusion Criteria:

* An active Central Nervous System malignancy (cancer)
* The presence of two or more current ventricular catheters indicating that the ventricles do not communicate with each other
* The inability of the parent/guardian or patient to provide informed consent
Autologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets

After people lose an eye, for whatever reason, they often experience fat atrophy of the tissues in the orbit. This leads to a sunken appearance that is often not correctable by a cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/ invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own disadvantages. This study seeks to demonstrate an improvement in the retention of injected autologous fat by mixing in autologous PRP (platelet rich plasma).


Eligibility Criteria:
Inclusion Criteria: anophthalmos, orbital atrophy -

Exclusion Criteria:poor anesthesia risk, people outside a 100 mile radius of New York City

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