cyrilzakka/clinical-trials huggingface dataset:
Online Screening and Empowerment Program for Children With SLD

One of the problems faced by health services that deals with the diagnosis and treatment of Specific Learning Disorders (SLD), like Dyslexia, Dysgraphia, Dysorthography and Dyscalculia, is the long waiting lists for first visits to possible confirm the diagnosis. One of the reasons explaining the long waiting times is that the school refers a large number of children to the hospital services who do not actually have SLD but a simple school difficulty. These two are very different conditions:

* SLD is a neurobiological and genetic-based disorder that, with various degrees of severity, lasts a lifetime. Epidemiological data of the FVG region report a prevalence of dyslexia of 3.1%. Therefore, a prevalence of SLD between 4 and 5% can be assumed. This is a condition whose expressiveness cannot be modified by an enhancement intervention;
* The school difficulties are not innate and are characterized by an initial slowdown in bed-writing learning. The prevalence of low-performance school difficulties is between 10 and 15%. This type of problem improves significantly following specific enhancement.

Resistance to enhancement intervention is precisely one of the criteria that is still used to distinguish a school difficulty from a SLD: students with SLD would be those who show resistance to specific educational interventions. This criterion is based on the assumption that SLD has a precise neurofunctional basis in contrast to school difficulties. These are a transitional condition, which can be modified by didactic adaptations and enhancement activities (Law 170/2010; regional resolution 933/2014 FVG).

The application of enhancement tools in the school environment would therefore make it possible to distinguish, on the basis of the response, subjects with simple school difficulties from those with suspected SLD and, therefore, to report just those one, to the health services for diagnostic confirmation, contributing to the reduction of the workload of the hospital services and the reduction of waiting lists. These results are very important for children with SLD who could be identified and treated in an early and timely manner. The aim of this project is to apply an online screening and further school enhancement process using the "InTempo software" to distinguish children with SLD from those with school difficulties, thus also obtaining data on the real incidence of SLD and school difficulties in The Friuli Venezia Giulia Region.


Eligibility Criteria:
Inclusion Criteria:

* Children attending the second year of the primary school (about 7-8 years of age)

Exclusion Criteria:

* Presence of biological problems associated to school difficulties
* Low cognitive level
Safety Study of Dexmedetomidine in Septic Patients

Septic patients in Intensive Care Unit always need mechanical ventilation and conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult septic patients of mechanical ventilation .

Inclusion Criteria:

Age: between 18 years mechanical ventilation RASS≥2 A diagnosis of sepsis within 48 hours

Exclusion Criteria:

Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users

Primary Outcome Measures:

Dose of dexmedetomidine

Secondary Outcome Measures:

RASS score Requirement for rescue intervention, RASS will be recorded per hour.

Eligibility Criteria:
Inclusion Criteria:

* intubated patients RASS≥2 A diagnosis of sepsis within 48h

Exclusion Criteria:

* Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users
Management of Paroxystic Atrial Fibrillation in French Intensive Care Units

The primary purpose of the study is to evaluate treatment of new onset atrial fibrillation in french ICU.

Atrial fibrillation (AF) is a common arrhythmia in the ICU and is associated with significant morbidity. However, curative treatment remains unclearly established. In fact, there are no specific recommendations for new onset atrial fibrillation in ICU and only few studies have assessed this topic.

The PAF-ICU trial is an observational, prospective, multicenter, transversal trial. The main objective is to evaluate the management of paroxytic atrial fibrillation that occur in ICU.

The investigators want to document 2500 episodes of paroxystic atrial fibrillation in 50 ICU centers. In each center, the episodes are included consecutively until the required 50 episodes are obtained for each center.

A patient can present several episodes and each episode can be included in the study. A new episode is considered as such if it occurs more than one hour after the previous episode.

The follow-up period for each patient corresponds to the ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient hospitalized in ICU
* New onset atrial fibrillation

Exclusion Criteria:

* Age \< 18 years
* Parturient or breast-feeding woman
* Persistent or permanent atrial fibrillation
* Patients after cardiovascular or thoracic surgery
* Patients with therapeutic limitations
Assessment of Schizophrenia Patients' Clinical Study Experiences

The study seeks to delve into the firsthand experiences of patients diagnosed with schizophrenia who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

The data collected from this study will help improve future outcomes for all schizophrenia patients as well as those in under-represented demographic groups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* Considered reliable, able to understand, and willing to perform all study procedures
* Signed Written Informed Consent

Exclusion Criteria:

* Currently enrolled in, have completed or have discontinued from a clinical trial involving an investigational drug
* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Any serious and/or unstable pre-existing medical disorders
Doppler Ultrasound in Early Detection of Diabetic Nephropathy Type 2 Diabetes Mellitus.

Doppler sonography provides an easily applicable, non-invasive, and well-established method for investigating renal morphologic characteristics and measuring vascular resistance in the renal parenchyma. Doppler are of strategic importance in providing qualitative and quantitative information about the renal vasculature, which can be obtained through the assessment of the resistive index.

Nephropathy is one of the most common long-term, life-threatening complications causing a high rate of morbidity and mortality among individual patients with type 2 diabetes.

The onset and progression of nephropathy can be delayed by interventions, provided they are instituted early in the course of the disease.

Doppler sonography allows non-invasive method for investigating renal hemodynamics. Renal resistive index measured using Doppler ultrasonography, reflects intra-renal vascular resistance.

Although Doppler sonography clearly does not substitute for renal biopsy, several studies have suggested that it might aid in the management of established renal disease and provide an easily applicable and noninvasive method for investigating renal hemodynamics.

Doppler sonography provides an easily applicable, non-invasive, and well-established method for investigating renal morphologic characteristics and measuring vascular resistance in the renal parenchyma. Doppler are of strategic importance in providing qualitative and quantitative information about the renal vasculature, which can be obtained through the assessment of the resistive index. It is one of the most sensitive parameters in the study of kidney diseases and allows us to quantify the changes in renal plasma flow . A normal resistive index is below 0.7 in adults and children who are six years of age or older.

Eligibility Criteria:
Inclusion Criteria:

* 1. Type 2 diabetic patients. 2. Serum creatinine \<1.2 mg/dl

Exclusion Criteria:

- 1. patients with known history of renal disease or any systemic diseases with renal complications.

2. Serum creatinine \>1.2 mg/dl
The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows mask will be recruited.

The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OSA by Physician
* ≥ 22 years of age
* ≥ 66 lbs
* Prescribed PAP or BPAP therapy for OSA
* Existing nasal, sub-nasal and pillows mask users
* Fluent in written and spoken English

Exclusion Criteria:

* Inability to give informed consent
* Pregnant or think they may be pregnant
* PAP Intolerant
* Anatomical or Physiological Conditions that make PAP inappropriate
* IPAP pressure of ≤25cmH20.
* PAP/BPAP therapy device without data recording capabilities
* Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen
Evaluation of Serum Galectin-9 Level in Systemic Lupus Erythematosus Patients and it's Association With Disease Activity and Organ Damage

Study aims to evaluate serum galectin-9 in systemic lupus erythematosus patients and determine it's correlation with overall disease process

Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by producing large quantities of antibodies directed against self-antigens, particularly double stranded DNA (dsDNA) and small nuclear RNA-binding proteins such as Ro, La, Sm, and nRNP.

SLE-associated autoantibodies and high serum interferon alpha (IFN-α) are two important heritable phenotypes in SLE which are thought to play a role in disease pathogenesis . The most remarkable feature of the anti DNA response is its association with immunopathologic events especially glomerulonephritis . Immune complexes containing DNA can promote the expression of interferon alpha (IFN-alpha) by a specialized population of dendritic cells known as plasmacytoid dendritic cells .

Activation of the type I interferon (IFN) system is associated with disease pathogenesis in SLE, with affected patients typically demonstrating high concentrations of type I IFN proteins . Overexpression of type I IFN-induced genes that includes hundreds of gene transcripts; which is termed interferon signature (IFNGS), has been observed in 60-80% of adults and the majority of children with SLE .

Galectin-9 (Gal-9) is recognized as a novel, easy to measure biomarker for type1 IFN signatures and galectin-9 could aid in clinical decision making in SLE as a marker for disease activity and organ damage.

Galectin-9 is expressed by T cells, macro-phages, fibroblasts, and endothelial cells, its secreted form is barely detected under physiological conditions, it plays an recognizable role in the regulation of inflammation and immune responses by down-regulating pro-inflammatory T cells.

Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed systemic lupus erythematosus patients.

Exclusion Criteria:

* Individuals with other autoimmune diseases: 1)rheumatoid arthritis patients 2)dermatomyositis 3)scleroderma 4)mixed connective tissue disease
Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)

Headache following a lumbar puncture （post-lumbar-puncture headache,PLPH）is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the severity of PLPH.

Headache following a lumbar puncture （post-lumbar-puncture headache,PLPH）is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the severity of PLPH.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as acute leukemia, or lymphoma
* Patients will received repeated lumbar puncture (at least 2 times, and at least 2 weeks apart) and intrathecal treatment
* Without CNS involvement
* Without headache for at least 1 week before the day of lumbar puncture
* The platelet count was at least 30×10e9/L

Exclusion Criteria:

* With CNS involvement of disease
* With headache before lumbar puncture
* Needs lumbar puncture more than once a week
Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.


Eligibility Criteria:
Key Inclusion Criteria

* Signed written informed consent
* Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
* Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
* Men and women, ages 18 and older

Key Exclusion Criteria

* A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy
* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
* Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
* Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)
New Conservative Technique for Placenta Accreta Spectrum

participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery.

Investigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed.

Data were collected about the outcome.

Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to help sure diagnosis of PAS.

Cesarean section will be performed through extended transverse supra-pubic incision bladder dissection from anterior uterine wall using electro-coagulation instruments and double ligation of large caliber bridging vessels.

Uterine incision above the placental bulge by at least 5 mm then complete separation of the placenta starting from least resistance plans to high resistant one leaving a clear defect which will be closed by running sutures from inside the uterus and controlling placental bed hemorrhage then closing the uterine incision with compressing the bed from outwards ( double compression sutures ) internal Iliac artery ligation may be done as a complementary measure to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain and closure of abdominal wall in layers.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age.

Exclusion Criteria:

* pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders.

pregnant women had 5 or more previous Cesarean sections or their age more than 40 years
Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis

This project aims to provide values of test-retest reliability and insights from concurrent validity of outcome measures for pain in multiple sclerosis.

Pain is one of the most annoying symptoms in multiple sclerosis (MS). However, it is underestimated albeit its high prevalence rate with 63%. It negatively affects health related quality of life, activity of daily living, mental health, social functioning, employment, sleep and life enjoyment. In literature, the prevalence of pain varies in the MS literature from 29% to 86%. This wide-range prevalence is the result of methodological differences and non-uniformity of the studied populations which makes pain unclear and underdiagnosed in multiple sclerosis.It is hypothesized that the consistency, severity and interference of pain have varying relationships between other factors such as depression, anxiety, sleep or fatigue.

Evaluating pain was done with various outcome measures resulting in inconclusive results. However, very few of the pain outcome measures are validated for MS population. Thus, it cannot be advised yet whether they contain similar or complementary information. Finally, the interference of pain on activities and participation level of the International Classification of Functioning, Disability and Health (ICF) is poorly documented.

This project aims to put the foundations for future interventional research by providing values of test-retest reliability and insights from concurrent validity. As well, the perceived interference from pain on activities and participation level will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above,
* Ambulatory pwMS with definite diagnosis based on McDonald criteria
* Expanded Disability Status Scale of 6.0 or below,
* Having pain in last month
* Able to understand and answer the questions in the questionnaires.

Exclusion Criteria:

* Diagnosed with major musculoskeletal disorder and any neurological disorder other than MS,
* a relapse in the last month before enrolment,
* cognitive decline that renders the patient incapable of performing tests and questionnaires,
* patients with only headache
Biomarkers for Intestinal Permeability in Patients With Constipation

Our overall objective with this study is firstly to provide a comprehensive assessment of intestinal permeability, mucosal barrier function using existing biomarkers and secondly to explore novel biomarkers for measuring intestinal permeability in patients with constipation predominant Irritable Bowel Syndrome (IBS-C).

In order to determine the differences in permeability in IBS-C in comparison with healthy volunteers, the following will be determined: differences in in vivo small intestinal and colonic permeability, differences in small intestinal and colonic mucosal barrier function, differences in effects of fecal supernatants on barrier function of T84 monolayers, and differences in novel biomarkers for intestinal permeability

Eligibility Criteria:
Inclusion criteria:

1. 18 - 65 years old
2. IBS-C by Rome III criteria (for IBS-C participants)
3. No abdominal surgery (except appendectomy and cholecystectomy)

Exclusion criteria:

1. History of Inflammatory Bowel Disease (IBD) , microscopic colitis or celiac disease
2. Use of tobacco products within the past 6 months
3. Use of NSAIDs or aspirin within the past week
4. Use of oral corticosteroids within the previous 6 weeks
5. Ingestion of artificial sweeteners such as Splenda (sucralose), Nutrasweet (aspartame), lactulose or mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints and diet soda
6. Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins

   1. Any treatment specifically taken for IBS, including loperamide, cholestyramine, alosetron
   2. Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors (e.g, tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazapine);
   3. All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in combination)
   4. Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline).
   5. Ultram
   6. GI preparations

      * Anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine, dimenhydrinate, hydroxyzine)
      * Osmotic laxative agents (e.g, lactulose, sorbitol or PEG solutions as Miralax and Glycolax)
      * Prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone);
   7. Antimuscarinics;
   8. Peppermint oil;
   9. Systemic antibiotics, rifaximin, metronidazole.
7. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
8. Score \> 8 for anxiety or depression on Hospital anxiety and depression scale.
9. Pregnancy
The Effects of Secondary Smoking During One Lung Ventilation

Smoking and perhaps secondary smoking is associated with many perioperative and postoperative complications, especially respiratory events. Hypoxemia and airway damage can be associated with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway damage during one lung ventilation for lobectomy.

Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube will be included in this study. These patients will be divided into 2 groups. Groups S which will be included non smoking and secondary smoking and group SS which will be included secondary smoking ( smoking near him more than 10 cigarettes per day fore more than 5 years). Intra and postoperative arterial oxygen tension, arterial carbon dioxide tension and intraoperative peak airway pressure will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, ASA physical status 2 and 3.

Exclusion Criteria:

* Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma.