cyrilzakka/clinical-trials huggingface dataset:
Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years

GnRH agonists are used in the treatment of precocious puberty in order to improve adult height.However,the psychosocial impact of precocious puberty is often used by the clinician at diagnosis to justify treatment, but can not yet be properly assessed. It can not be considered as a rational neither for the indication to treatment, nor to assess its potential efficacy.

The overall objective of this work is to improve the conditions leading to the therapeutic decision and the procedures for monitoring girls with idiopathic central precocious puberty.

During the day hospital, the diagnostic workup for precocious puberty will be performed and include:

* A clinical examination with pubertal stage assessment.
* A GnRH test
* A Pelvic ultrasound
* An MRI will be performed later after the results of GnRH test confirming precocious central puberty.

These reviews are conducted as part of usual care and are required to validate the inclusion criteria of patients.

The CBCL questionnaire will be completed by patient's parents and the first semi-structured interview will be conducted by a sociologist assisted by the psychologist, dedicated to the study.

Patient's follow-up will be planned 6 months after inclusion, including similar investigations (except MRI).

Eligibility Criteria:
Inclusion Criteria:

* 6 to 8 years old girls, with idiopathic central precocious puberty defined as:

  * Onset of clinical signs between 6 and 8 years excluded: breast development (Tanner stage S2 or more), possibly with pubic hair or accelerated growth rate.
  * The GnRH test: LH peak\> 5 IU / l during the test.
  * Pelvic ultrasound: uterine length\> 34 mm
  * The normality of the hypothalamic-pituitary region assessed by magnetic resonance imaging (MRI).
* Parental Informed and written consent

Exclusion Criteria:

* Parents and / or children do not speak French
* Other chronic disease
* The child does not benefit of the French social security cover
Effect of Vaginal Intercourse on Spontaneous Labour at Term

Vaginal intercourse to promote labour onset is biologically plausible. Oxytocin release during female orgasm, cervix mechanical stimulation and the effect of semen's prostaglandins are possible involved mechanisms. The investigators propose to evaluate the effect of vaginal intercourse on spontaneous labour at term.


Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy
* Singleton pregnancy
* Cephalic presentation
* No previous cesarean section
* Irrelevant obstetric history
* Surveiled pregnancy without complications
Comparison of Standard of Care Guidelines for Mycoplasma Genitalium Infections Among Men With Non-gonococcal Urethritis

The purpose of this protocol is to determine the difference in clearance of Mycoplasma genitalium (MG) when using the Australian management protocol versus the current Centers of Disease Control (CDC) treatment guidelines for US standard of care (SOC), to determine the proportion of men from the Deep South, with NGU attributable to MG, and to determine the proportion of MG cases that harbor the macrolide-resistance associated with mutation.

Mycoplasma genitalium (MG) has been associated with non-gonococcal urethritis (NGU) in many populations and the prevalence of MG strains with macrolide-resistance associated gene mutations is increasing . While no MG diagnostic assays have FDA clearance in the United States (US), treatment for NGU is primarily focused on managing potential infection with Chlamydia trachomatis (CT) using single dose 1 gm Azithromycin (a macrolide class of drug). Without testing for MG that might alter NGU treatment strategies, the current paradigm may be contributing to selective pressure resulting in increased macrolide resistance in MG. In Australia, awareness of the prevalence of MG and macrolide resistance-associated mutations has been facilitated by an approved diagnostic test manufactured by SpeeDx. Ltd. As a result of the epidemiologic information generated by this diagnostic tool \[MG ResistancePlus (MRP) Assay\], the Australian Sexual Health Alliance, who publish the Australian Sexually Transmitted Infection (STI) Management Guidelines for Use in Primary Care, have revised the management of men with NGU and MG infection. The new management guidelines include initial treatment of NGU with doxycycline, and concomitant testing for MG and macrolide resistance, with subsequent treatment for MG infected patients according to resistance results. We propose using the MRP assay in a population of men with NGU to determine the clinical impact of the Australian treatment strategy compared to the current standard of care for NGU on clearance of MG infection.

Eligibility Criteria:
Inclusion Criteria:

* Presenting with symptoms of urethritis (dysuria and/or urethral discharge)

Exclusion Criteria:

* Non-English speaking
Fluorescent Visualization in Early Oral Cancer

Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proven invasive oral cancer or severe dysplasia / Cis
* invasive cancer must be T1 or T2
* no prior history of oral cancer / treatment of oral cancer

Exclusion Criteria:

* prior history of oral cancer
* unable to provide informed consent
* lesion not able to be completely visualized by FV
Effects of VSL#3 on Metabolic, Endocrine, Lipidomic and Inflammatory Parameters of Pediatric Patients With BMI>90°

Obesity in children has become a significant social problem considering that nowadays 4 to 5 % of all children are obese in the industrialized countries with increased incidence in Europe by 10 to 50% over the past 10 years. Obesity is associated with the metabolic syndrome in 30% of the children and is considered as a state of chronic inflammation inducing the production of pro-inflammatory cytokines which determine metabolic and endocrine alterations on the organism. It has been observed that obesity is also linked to a change in the intestinal microflora with a reduction of Bacterioides and bifidobacteria and a decrease of Firmicutes and Staphylococcus aureus. The qualitative and quantitative analysis of the metabolites may provide us with a characterization of the existing phenotypes and variations in relation to the changes of the physiological state, in particular when supplemented or not with a probiotic preparation.


Eligibility Criteria:
Inclusion Criteria:

* age 6-12
* parents or tutors able to give the written consent and follow the study procedures Value of BMI\>90°

Exclusion Criteria:

* - Any severe or concomitant clinical or psychiatric condition that, in the investigator's opinion, could affect the treatment, the evaluations and the inclusion in the protocol;
* Evidence of active liver disease due to other causes;
* Steroid treatment; immuno suppressive therapies, chemotherapy agents within 2 month from screening;
* Pregnancy or breastfeeding;
* Abuse of alcohol and drugs clinically relevant;
* Diabetes.
Phage Therapy for the Prevention and Treatment of Wound Infections in Burned Patients

The central aim of this trial is to investigate the safety and tolerability of Phage Cocktail-SPK as an adjunct to standard therapy for the prevention and treatment of burns susceptible to infection/or infected by S. aureus, P. aeruginosa, or K. pneumoniae species. It is hypothesized that no adverse events, clinical abnormalities, or changes in laboratory tests results related to the application of Phage Cocktail SPK Spray will be observed.

This is a Phase I, randomized, open-label, active controlled study to evaluate the safety and tolerability of a Phage Cocktail-SPK therapy for second degree burn wounds in adult patients. The wound will be clinically selected on the basis that it is a second degree burn less than 10 percent of total body surface area, and that, according to medical assessment, should heal without surgical intervention. The study is intended to include one site outside of the United States of America, namely the Royal Brisbane and Women's Hospital, in Brisbane, Queensland, Australia.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and lifestyle considerations, and availability for the duration of the study
3. Male or female, aged 18 years or older presenting at the emergency department, out-patient burn department or in-hospital patients with a thermal second degree burn wounds (American Burn Association severity classification).
4. Patients with a burn wound covering less than 10% of their total body surface area (TBSA) and present within 7 days of their injury, with or without signs of local infection, expected to heal without the need for surgery.
5. For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of administration of the study intervention
6. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

1. Current use of dressings containing silver or nanocrystalline silver
2. Pregnancy or lactation
3. Clinical evidence of invasive infection based on American Burn Association consensus conference(Greenhalgh et al., 2007).
4. Burn wounds present in anatomic locations such as burns on the face, hands, feet, genitals, perineum, as well as sites at high risk for developing compartment syndrome (deep circumferential extremity burns).
5. Known allergic reactions to components of Xeroform or Kenacomb.
6. Patients diagnosed with Type I or Type II diabetes.
7. Treatment with another investigational drug or other intervention within 30 days
8. Intercurrent condition requiring a high dose of chronic corticosteroid therapy, immunosuppressive medication, oncologic chemotherapy.
9. Patients who have additional uncontrolled serious medical or psychiatric illness determined by the investigators where the patient is unfit to receive PGX-0100.
Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax

For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb obliteration with pleural adhesive procedure is generally accepted as a standard. But additional pleurodesis is potentially useless procedure on the parietal pleura for treating visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural physiology and cause chronic pain. According to our previous study, stapling resection of the bulla without pleurodesis gave comparable result in recurrence comparing with articles with additional pleurodesis. The purpose of this study is to evaluate surgical outcome of thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure is essential in the management of PSP.


Eligibility Criteria:
Inclusion Criteria:

* recurrent pneumothorax
* bilateral pneumothorax
* total collapse/tension pneumothorax
* previous history of contralateral pneumothorax
* visible bulla on simple X-ray
* special occupation/situation
* air leakage more than 2 days with drainage catheter for 1st attack patients

Exclusion Criteria:

* patient refusal and reoperation case
ABC Mental Health: A Behavioral Study of K-12 Teachers and School Staff

This study looks at school employees' mental health, well-being, and effectiveness before and after completing a professional development workshop. The participants' schools are offering the Cultivating Awareness and Resilience in Education (CARE) professional development workshop to all teachers, staff, and administrators. CARE will be presented in three in-person training sessions over two to three months during the school year.

People who participate in CARE are asked to answer questions about their demographic information, mental health, well-being, and effectiveness before the workshop and two times after completing the workshop. This consent form provides the necessary information for people interested in answering these questions to make an informed decision. This consent form is not for the professional development workshop. Taking part in the workshop and questionnaires is optional.

This study is being conducted because teachers, school staff, and children's mental health has declined since the beginning of the COVID-19 pandemic. The investigators hope to use information collected in this study to tell schools, local public health officials, and state leaders how best to support teachers' mental health and well-being.

There are minimal risks associated with this study. The greatest risk of this study is loss of confidentiality.


Eligibility Criteria:
Inclusion Criteria:

* Adult participant, defined as an adult (18 years or older) employed by a school working with youth in kindergarten through 12th grade.
* Fluent in the English language

Exclusion Criteria:

* N/A
Prevalence of Masked Hypertension in Nephrological Patients

The purpose of this study is to determine the percentage of patients with masked hypertension in a population with chronic kidney disease. The investigators goal is to register prospectively ambulatory blood pressure measurement results of patients of a nephrological outpatient clinic with normal office blood pressure to finally find the percentage of masked hypertension in this population.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-90 years
* Known arterial hypertension and antihypertensive medical treatment
* Office blood pressure \< 140 mmHg systolic and \<90 mmHg diastolic

Exclusion Criteria:

* Age \<20 or \>90 years
Video Game Exercise Effectiveness of a Domiciliary Pulmonary Rehabilitation Program in Cystic Fibrosis Patients

The aim of this study is to evaluate the efficacy of a long-term domiciliary exercise program using the Wii video game platform as a training modality in Cystic Fibrosis (CF) patients. Investigators hypothesize that an exercise program performed by active videogames (AVG) will produce an improvement in exercise tolerance and muscular strength to be maintained over time in young CF patients.

This is a randomized and longitudinal trial. Participants will be randomize in 2 groups: control group (CG) and experimental group (EG), by the ©GrapfPad Software, Inc. The CG will carry out their routine patient management, and the EG will perform also a domiciliary Pulmonary Rehabilitation program of 30-60 min exercise, 5 days/week during 6 weeks using a Nintendo WiiTM platform with the game EA SPORTS ACTIVE 2.

Before and after we will measure:

1. exercise tolerance using the six minutes walk test (6MWT) and the modified shuttle walk test (MSWT);
2. muscular strength using horizontal jump test (HJT), medicine ball throw (MBT) and handgrip strength (right hand (HGR); left hand (HGL)); and
3. HRQoL using the 3 versions of the Cystic Fibrosis Questionnaire-Revised (CFQ-R 6-11, CFQ-R 14+, CFQ-R Parents).

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of CF, clinically stable without exacerbations of the disease in the previous 6 weeks to the inclusion date.

Exclusion Criteria:

* To present clinical evidence of cardiovascular, neuromuscular or osteo-articular comorbidities that limit the participation in exercise programs.
* Lung transplant candidates and those patients that followed any kind of rehabilitation program 12 months before the study.
Evidence Based Algorithm for Proximal Humerus Fractures

Proximal humerus fractures are particularly frequent injuries and represent 6% of all fractures with an overall incidence of 63/100.000 in human. The goal is to assess our institutional evidence based algorithm for treatment of proximal humeral fractures.

Objective(s):

1. Test the algorithm in terms of clinical applicability and clinical outcome
2. Compare general outcome and general complication/revision rate to the literature.

Inclusion / Exclusion criteria: Inclusion: All patients with an acute proximal humeral fracture (not older than 48 hours) admitted to our institution later than 1.1.2014. Exclusion: Multilevel and pathological fractures are excluded.

Terminally ill patients and those not being able, or willing to sing the informed consent.

Project Centre(s): Single-centre.

Statistical Considerations: Standard descriptive statistics will be performed using R-statistics program. Considering the population of 160 patients, we will be able to detect differences in proportions as low as 0.15 with power 82% and alpha = 0.05.

Other methodological Considerations: Terms applicability of a treatment protocol and adhesion to protocol are not well defined for decision making in orthopaedic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Acute traumatic proximal humeral fracture
* Signed informed consent

Exclusion Criteria:

* Fracture older than 48 hours at admission
* Multilevel fractures of the humerus
* Pathological fractures
* Terminally ill patients.
Rapid Onset Action of Salbutamol Versus Formoterol

The hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled Formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e., the difference in mean forced expiratory volume in 1 second (FEV1) between the 2 groups at 1, 5, 10, 30 and 60 minutes will be less than 10% in children between 5-15 years with mild acute exacerbation of asthma.

It is desirable to have a single MDI that can be used as both LABA and SABA. There are few studies involving few children on use of formoterol that shows rapid bronchodilatation in children with asthma and no study that used it as rescue drug in children with acute exacerbation of asthma. The purpose of the present study is to evaluate whether the rapid bronchodilatory effect of formoterol is similar to that of salbutamol in children of 5-15 years with mild exacerbation of asthma.

Children will receive either salbutamol or formoterol by MDI. Participants will be explained about the study, spirometry and inhalation of medicine with MDI and spacer. Children will receive two puffs (100 microgram each of salbutamol) or Formoterol 2 puffs (6µg /puff) by MDI and spacer. Each child will be explained about the inhalation technique by using a MDI of placebo. After shaking the MDI it will be attached to spacer (700ml volume) and actuated. Child will be asked to take 5 tidal breaths. Another puff will be given by similar method.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or Pediatric OPD
2. Mild exacerbation will be defined as:

   * children presenting with increase in symptoms (cough, wheeze, breathlessness) for less than 7 days duration
   * no chest indrawing
   * no difficulty in speech
   * clinical asthma score (or pulmonary index score-annexure 1) between 6-9

Exclusion Criteria:

1. Children with life threatening asthma detected by presence of any of the following:

   * severe chest indrawing
   * cyanosis
   * irregular respiration
   * altered sensorium
2. Children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma
3. If child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol)
4. Child not able to perform spirometry
5. Parents refusing to give consent
Higher vs Lower Lumber Epidural Catheter Insertion During Labour: A Randomised Trial to Compare Efficacy.

This study will randomise pregnant women to labour epidural at a higher versus a lower lumbar level. Outcomes relating to success or failure of the epidural catheter at this level will be assessed.

Epidural analgesia is widely used in different types of surgeries and procedures. Pregnant women in labour compromise the single largest group benefiting from epidural analgesia. During first stage of labour (dilatation of the cervix), an epidural should cover the sensory dermatomes from T10 to L1 to achieve a good pain relief. In the second stage of labour (descent of the baby through the cervical canal), pain is mediated via S2-S4 nerve roots. Accordingly, labour epidurals are commonly placed at the lower lumbar (L3-L4) interspace.1 A study was conducted by Moore et al., comparing high vs low lumbar epidural, showed that lower epidurals provide superior perineal analgesia, when used with a patient-controlled epidural analgesia (PCEA) infusion with continuous epidural infusion (CEI), but provided less pain relief early in labour. Another study, a metanalysis showed that another mode of delivery of the local anaesthetics is more effective; which is the Programmed Intermittent Epidural Boluses (PIEB) with PCEA. The incidence of breakthrough pain, the rates of local anaesthetic usage were significantly reduced, the labour duration was statistically shorter, and the maternal satisfaction score was significantly improved in the PIEB + PCEA group compared with that in the CEI + PCEA group.

This is a prospective randomised study where women will be randomised to a high or low epidural catheter to determine which is superior for maternal analgesia efficacy and satisfaction.

Randomised to intervention 'high epidural' or 'low epidural' groups. Within these groups there are two subgroups based on the specific lumbar vertebral level; high epidural (L 1,2 or L 2,3 levels) and low epidural (L 3,4 or L 4,5 levels).

Eligibility Criteria:
Inclusion Criteria:

Women electing to have epidural analgesia in labour

Exclusion Criteria:

Known contraindication to epidural analgesia. Neurological illness Multiple gestation Fetal abnormalities In distress or requiring immediate epidural catheter placement
Prevalence of OSA in Patients of ILD

To evaluate the clinical predictors of OSA in patients with ILD

Interstitial lung diseases (ILDs) are a group of heterogeneous disorders characterized by varying degrees of fibrosis and inflammation of lung parenchyma.

Obstructive sleep apnea is a type of sleep disordered breathing characterized by repeated episodes of apnea and hypopnea during sleep due to narrowing or occlusion of the upper airway.

It was found that the prevalence of OSA is as high as 80% among patients with idiopathic pulmonary fibrosis (IPF). Despite this common association, there is limited research in this field. There is great need for further studies to highlight this association and understand the underlying pathophysiological mechanisms implicated in those patients, to ultimately guide the appropriate management.

Eligibility Criteria:
Inclusion Criteria:

* Patients presented to Chest Department with interstitial lung disease will be included, screened for OSA.

Exclusion Criteria:

* Age: less than 18 years. Unstable patients or need for ICU admission