cyrilzakka/clinical-trials huggingface dataset:
Study of Colchicine Resistance in Familial Mediterranean Fever

Five to 10% of familial mediterranean patients are considered colchicine-resistant (i.e. patients with a persistent inflammatory syndrome, despite taking the maximum tolerated dose of colchicine daily). The recommended treatment in this case is a subcutaneous anti-interleukin 1 biotherapy (anakinra or canakinumab). These treatments are expensive (1,000 to 12,000 euros/month).

However, for a patient to be considered colchicine-resistant, compliance with the treatment must be verified. Furthermore specific activation of the pyrin inflammasome by Clostrioides difficile toxin and the overrepresentation of these bacteria in the stools of our patients led us to systematically search for them in our resistant patients. The demonstration of the involvement of C. difficile in the imbalance of the disease has not yet been published.

The colchiresist study aim to better characterize colchicine-resistance by confirming good compliance to treatment with colchicine hair measurement and by looking for clostrioides infection or intestinal dysbiosis.

Patients meeting the criteria for colchicine resistance will be included in a follow-up visit.

* Adherence to colchicine therapy will be assessed by the Girerd questionnaire completed by the patient at the inclusion visit.
* A blood test is performed including a haemogram, CRP and SAA, creatinine and proteinuria.
* a standard stool analysis on site to look for C. difficile toxin.

For research purposes, samples of:

* Stool.
* A strand of hair with the diameter of a pencil and a minimum length of 2 cm, in the region of the posterior vertex, where the growth and integration are relatively constant to avoid variability.
* In patients with baldness or bleached hair only: pubic and/or axillary hair will be taken, The samples will then be processed without segmentation.
* Additional blood (5ml) and urine (2ml) samples for colchicine dosage. The patient's participation ends after this visit

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria Age ≥ 12 years with no upper age limit -Patients with familial Mediterranean fever (FMF) meeting international criteria for the disease (Livneh criteria) and carrying 2 pathogenic mutations in the MEFV gene.

Patients considered colchicine-resistant according to EULAR criteria reviewed by an expert consensus:

* Persistence of signs of activity (at least one attack per month for at least 3 months) despite taking the maximum tolerated dosage of colchicine.
* Persistence of a biological inflammatory syndrome after exclusion of other causes and despite taking a maximum tolerated dosage of colchicine.
* Signature of an informed consent by the patient (or his parents if under 18 years of age)
* Patients affiliated to a social security system

Exclusion Criteria:

- Patients participating in another interventional trial
Sardine-enriched Diet for Prevention Type 2 Diabetes

The hypothesis formulated is that 200 g of sardine on a weekly basis will have a favourable impact avoiding the natural development of the pathology due to changes in the biochemical profile, the anthropometrics, inflammatory markers, changes in gut microbiota populations, also in transcriptomics and metabolomics.


Eligibility Criteria:
Inclusion Criteria:

* glycaemia between 100-125 md / dL or ≥5.7% HbA1c

Exclusion Criteria:

* treatment with oral antidiabetic drugs
* any nutritional education to prevent T2D
* Suspect or known hypersensitivity to sardine or related fish
* Chronic treatment with oral steroids and / or AINES
* Treatment with oral antidiabetic agents and / or insulin
* Treatment with immunosuppressive drugs
* Diagnosis of active neoplasm
* Diagnosis of HIV or AIDS
* Abnormal liver profile (\> 6 times normal values)
* Diagnosis of Acute Psychiatric Sdr
* Presence of serious acute concomitant disease, which it requires more than 7 days of recovery.
* Major cardiovascular event (stroke, myocardial infarction) in the month prior to randomization.
* Any other condition that the investigator considers to be inoperative so that the subject conducts the study.
Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter

* Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. We will evaluate the capability of the INVOS Oximeter to detect induced changes in the cerebral regional saturation.
* The purpose of the study is to investigate our hypothesis that a particular CPAP flow pressure optimizes the regional cerebral oxygenation.

Preterm infants are at increased risk of brain damage compared with term infants, and cerebral hypoxia is considered to have an important role. The preterm infants are at increased risk of respiratory distress, episodes with low oxygenation, mechanical ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of interest, since high levels of oxygen can cause vasoconstriction. Preterm infants is often treated with CPAP (Continuous positive airway pressure), but the effect of different flow pressures on the regional cerebral oxygenation is not known.

The investigators will examine the normal physiological response of the brain in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants to the commonly used treatment in neonatology, CPAP (Continuous positive airway pressure).

The investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). INVOS® is the first NIRS-based oximeter CE-approved for hospital use in Denmark.

There will be no follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria: - Newborns with a gestational age of 32-40 weeks - Clinically stable - +/- CPAP with a oxygen limit below 30% - Parental consent

Exclusion Criteria:

* Severe birth asphyxia - Prohibition of oxygen exposure
Inferior Vena Cava Assessment in Term Pregnancy Using Ultrasound: a Feasibility Study of Subxiphoid and RUQ Views

This study is to assess the feasibility of 2 different ultrasound views of the inferior vena cava (IVC), a large vein that returns blood to the heart. Ultrasound is safe in pregnancy and, is regularly used to evaluate the fetus. It is hoped that imaging of the IVC will then allow us to determine the fluid status of the parturient which could be helpful in treating hemodynamic instability. This study will not involve any change in management of the participating patients.

Anesthesiology consultants and trainees with US experience will first perform scans from the RUQ view starting on the mid-axillary line at the T4 intercostal space, looking to obtain a view of the IVC as it enters the right atrium (RA). Following successful acquisition, the examiner will perform scan from the subxiphoid position, looking to obtain the same view of the IVC transitioning into the RA. Primary endpoint will be time to obtaining quality of images. The investigator will use a stopwatch to time acquisition of images. If the duration of scanning exceeds ten minutes, the scan will be discontinued and labeled as failed. Each image will be separately reviewed by 2 different US specialists with extensive US experience. Images will be assessed according to a Likert scale from 1 to 5. (Very poor (1), poor (2), acceptable (3), good (4), very good (5)) Secondary endpoints will be assessed as follows: 1. Acceptability: all patients participating in the study will complete a questionnaire to assess acceptability. 2. Comfort: During the exam the patient will have the option to suspend the scan by stating they are uncomfortable and wish to stop. Each request will be noted and taken into the account at data analysis. Furthermore, patients will be given a questionnaire at the end of the scan and asked to rate their comfort level during procedure according to Likert scale. (Very comfortable (5), comfortable (4), equivocal (3), uncomfortable (2), very uncomfortable (1)) 3. Ease of exam: Examiner will rate the ease of image acquirement according to Likert scale. (impossible (1), difficult (2), equivocal (3), easy (4), very easy (5))

Eligibility Criteria:
Inclusion Criteria:

* Adults pregnant females,
* Age 18-45,
* Term pregnancy Parturients not in established labor Singleton pregnancies

Exclusion Criteria:

* Advanced labor,
* Multiple gestations,
* Maternal or fetal distress,
* BMI \> 45.
* Inability to obtain informed consent
Impact of Telemonitoring for the Management of Side Effects in Patients with Melanoma, Lung or Renal Cancer, Treated with Immunotherapy Combination of Nivolumab and Ipilimumab or Adjuvant Nivolumab Monotherapy

The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3/4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Grade 3/4 AEs are more frequently observed (50-60% of patients) in melanoma because ipilimumab is administrated at 3mg/kg in this population. Among these AEs, early detection of immune related AEs is critical to an adequate medical management. In this context, dedicated tools for remote monitoring of these patients are crucial.

The investigators developed within the Immucare consortium a simplified medical questionnaire which is addressed weekly to the patients. This questionnaire along with an algorithm gives to the clinician regular feedback on their patients' general symptoms. The investigators herein want to evaluate in a randomized prospective trial the efficacy of this remote monitoring to reduce the time between the start of AE and the reporting to the medical team, which could lead to detect and treat earlier AEs induced by nivolumab and ipilimumab in the melanoma, lung and renal cancer patients' population.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients diagnosed with melanoma, or lung cancer or renal cancer
* Patients starting a treatment with a combination of immunotherapy of nivolumab + ipilimumab (NB: patients who have already received immunotherapy in the past may be included)
* Patients comfortable with the use of digital tools and computing
* Patients who agree to participate to the telemonitoring and signed consent form

Exclusion Criteria:

* Pregnant, parturient and lactating women
* Patients under legal protection measure or deprived of their liberty
* Patients not affiliated to a social security scheme (schemes such as the AME) or beneficiaries of a similar regime (foreign person, outside the EU)
Spondylodiscitis Cases at Assiut University Hospital

The term Spondylodiscitis (SD) involves infection of the vertebra (Spondylitis), infection of the intervertebral disc (Discitis), or both (Spondylodiscitis) Spondylodiscitis is a rare disease accounting for 2.7% of all cases of pyogenic osteomyelitis, with incidence varying from 1 per 100,000/year to 1 per 250,000/year However, there is evidence that the incidence is rising due to longer life expectancy for patients with increasing incidence of chronic debilitating disease including diabetes mellitus, malignancies ,(Human Immunodeficiency Virus (HIV)/ Acquired Immunodeficiency Syndrome (AIDs) , immunosuppressive therapy, increasing numbers of Intravenous drug users , and spinal surgeries.

Pathogens can reach the spine either by: hematogenous spread, direct external inoculation, or spread from contiguous tissues harboring these pathogens. The hematogenous route is the predominant one, allowing seeding of infection from distant sites into the vertebral column.

Since spondylodiscitis has not been studied in a clinical trial at our hospital, and information about this disease has come from retrospective case series and isolated cases. In this study, we present our prospectively collected patient clinical and epidemiological data in order to provide a proper management


Eligibility Criteria:
Inclusion Criteria:

* All patients who come into Assiut University Hospital and outpatient clinic with clinical symptoms suggestive of spondylodiscitis in all age groups including patients with known medical conditions and patients who underwent previous spine surgeries (post operative spondylodiscitis)

Exclusion Criteria:

* No patients will be excluded
Selfcare MAnagement InteRvenTion in COPD (SMART COPD)

To evaluate whether a digital support and communication platform for COPD patients after 6 months provides:

1. Decreased breathlessness on the basis of modified medical research council dyspnea scale \[mMRC\]
2. Improved health status and symptom relief based on COPD assessment scale \[CAT\]
3. Improved quality of life based on EQ-5D
4. Reduction in the number of incidents, hospital nights, the number of hospitalizations, outpatient contacts or the number of deaths related to COPD
5. A change in the classification of COPD severity based on GOLD A-D


Eligibility Criteria:
Inclusion Criteria:

The patient is included in the study in connection with visits to COPD.

* Diagnosed COPD J44 (newly discovered or existing)
* Have completed the consent form
* Is judged to be able to handle the intervention himself or with the help of staff or relatives

Exclusion Criteria:

Patient who declines to participate in the trial.

* Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner.
* Life expectancy \<8 months
* In other ways, treating physicians are deemed to be inappropriate to participate in the study, e.g. due to participation in another study.
Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy

Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal reflux disease (GERD), and failure of medical therapy is associated with a substantial morbidity. Many patients, particularly children with CP and GERD, continue to experience complications despite aggressive therapy because antisecretory medications do not address the primary reflux mechanism (TLESR). Furthermore, in patients with CP, surgical options are fraught with serious complications and long-term morbidity. Because the available treatment options for children with CP and intractable GERD are limited, new therapies are urgently needed. Baclofen, which has been shown in animals and humans to decrease TLESRs, may be a good alternative for the treatment of children with CP with intractable GERD.

Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal reflux disease (GERD), and failure of medical therapy is associated with a substantial morbidity. Many patients, particularly children with CP and GERD, continue to experience complications despite aggressive therapy because antisecretory medications do not address the primary reflux mechanism (TLESR).

This is a placebo controlled trial of baclofen for the treatment of GERD in children with CP.

Eligibility Criteria:
Inclusion Criteria:

* 3-18 years old
* Diagnosis of Cerebral Palsy
* Symptoms of GERD for at least 3 months
* At least 8 weeks on BID therapy with a PPI at a therapeutic dose at time of enrollment
* Normal upper gastrointestinal barium contrast study (UGI)
* Have a g-tube that is used for more than 75% of calories and a stable feeding schedule for at least 2 weeks
* If seizures are present, they need to be controlled and on stable medications for 4 weeks

Exclusion Criteria:

* Underlying electrolyte disturbance
* History of Nissen fundoplication
* Renal insufficiency
* Currently receiving baclofen
* Baclofen allergy
* Uncontrolled seizure disorder
* Lack of informed consent
Positive Pressure Treatment of Obstructive Sleep Apnea

Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?

Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 - 75
* Diagnosis of OSAHS with baseline AHI (Apnea-Hypopnea Index) equal or greater than 15 events/hr of sleep
* Able and willing to provide written informed consent
* Agreement to try PAP (positive airway pressure) as initial treatment approach
* Adequate clinical CPAP titration within two weeks of enrollment

Exclusion Criteria:

* Participation in another interventional research study within the last 30 days
* The need for more than one titration PSG (polysomnography)
* The use of sedatives or hypnotics during the titration PSG
* Major medical or psychiatric condition that would interfere with the demands of the study, adherence to PAP or the ability to commit to follow-up assessment.
* Prior prescription for, or exposure to PAP therapy within the previous year (except exposure to CPAP during clinical therapy titration.)
* Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD (chronic obstructive pulmonary disease) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\>45 mmHG) while awake or participants qualifying for oxygen therapy (arterial saturation \< or equal to 88% for more than five minutes).
* Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
* Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)
* Presence of untreated or poorly managed, non-OSAHS related sleep disorders:

  * moderate to severe periodic limb movements (greater or equal to 15 per hour with symptoms or arousals)
  * Restless Leg syndrome (greater than 10 per hour)
  * Males experiencing chronic insomnia
* Use of medications with hypnotic or sedative effects or regular use of night time sedatives or sleeping aids greater than or equal to one night per week.
* Consumption of ethanol more than 4 nights per week (CAGE criteria)
* Shift workers
Implementation of a Tool on Alimentary Empowerment in New-born Baby

The alimentation of the premature newborn children is one of main thing concerning of nurses and pediatricians in neonatology. The absence of common tool of evaluation of the children cause a great discrepancy in prescriptions and the practices of the nursing.The aim of this study is to estimate the improvement of the food empowerment of the premature newborn children after the introduction of a help tool at the food progress which allows to fit the prescription of food(supply) to the capacities of the newborn child.

If the importance of feeding premature newborns is a central concern during their management, the absence of an evaluation tool leads to a great disparity in their implementation (particularly marked by at regular times by the care teams), which can eventually lead to oral disorders. The possibility of an assessment of the newborn's skills could allow a homogenization of therapeutic proposals and thus a potentially faster progression of dietary independence of the newborn. This method could also encourage parental involvement in feeding care. The objective of the study is to evaluate the impact of a tool to help food progression on food autonomy.

Eligibility Criteria:
Inclusion Criteria:

* born before 37 weeks of pregnancy
* hospitalized in GHPSJ neonatology
* Predictable duration of hospitalization of at least 7 days

Exclusion Criteria:

* parents not speaking french language
* new borm with complication du to his prematurity
Potential Risk Factors and Predictive Model Construction of OBL During SMILE

To explore the prediction of OBL by deep learning model in SMILE surgery

The DL model was used to predict the OBL area during SMILE surgery by identifying the corneal full-view images before laser scanning. The DL model developed may assist surgeons to predict the possible OBL area of patients in advance, so as to adjust some surgical parameters and reduce the formation of OBL, which can avoid negative effects on surgeons' operation and patients' postoperative visual recovery, which has important practical significance.

Eligibility Criteria:
Inclusion Criteria:

* A condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 D when ocular accommodation is relaxed;
* Age ≥18 years;
* Spherical equivalent (SE) ≥ -10.0D;
* Corrected distance visual acuity (CDVA) ≥ 16/20;
* Stable myopia for at least 2 years;
* No contact lenses wearing for at least 2 weeks

Exclusion Criteria:

* The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
* A history of eye surgery;
* The presence or history of systemic diseases.
Evaluation of Depression In Chronic Obstructive Pulmonary Disease

Background:

Several clinical studies show high rates of anxiety and depressive disorders in Chronic Obstructive Pulmonary Disease (COPD), that suggest common underlying pathogenetic mechanisms of COPD and depressive disorders. The aim of this study is to evaluate the effects of aerobic exercise, proposed in the context of pulmonary rehabilitation, in a sample of COPD depressed patients without psychopharmacological treatment, through the correlation of some psychopathological variables and physical/pneumological parameters.

Methods:

The investigators have designed an observational longitudinal trial. The trial will be prospective 6-weeks randomized clinical study to evaluate the impact of aerobic exercise on depressive symptoms in 154 patient affected by COPD and depression, assessed by Hamilton Depression Rating Scale (HDRS). The investigators will also monitor anxiety, quality of life and neurocognitive function.

Outcome measures:

The investigators compare the variation of HDRS total score, as primary outcome measure, in two groups (A, B) of COPD depressed patients matched for: COPD status; depressive status; age; gender. Only the participants randomized in study group A will receive a 6-weeks aerobic exercise intervention.

Statistical analysis:

All tests are two-tailed and a p value 0.05 was considered significant. The difference between the two groups will be evaluated with Student's T test for normally distributed data, and with Mann-Whitney's U test, for those with not normal distribution. The normality of distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations among the variables under evaluation will be assessed by Spearman r correlation. Variables will be compared using the Chi-squared test or Fisher exact test for categorical variables.

Discussion:

There is a strong correlation between physical activity and mental health. Several data have suggested that aerobic exercise shows significant effects, comparable to pharmacotherapy and to psychotherapy, on reducing depressive symptomatology. The goal of our study is to propose an effective intervention to reduce the risk of severe depression in this special population, evaluating the variation of HDRS total score after the aerobic exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of COPD and depression, eligibility to perform pulmonary rehabilitation according to ATS and ERS guidelines.

Exclusion Criteria:

indication to restoring treatment of airway patency and current psychopharmacological treatment (including sleeping-pills).