cyrilzakka/clinical-trials huggingface dataset:
Alternative Care in Patients With Auto-Immune Diseases

Patients followed in Internal Medicine bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. The main objective is the evaluation of the proportion of the use of alternative medicines in patients with in the department of Internal Medicine A

Patients followed in Internal Medicine department bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. The main objective is the evaluation of the proportion of the use of alternative medicines in patients with autoimmune diseases in the department of Internal Medicine .

At all times alternative medicine has existed. Internal Medicine deals with rare autoimmune diseases, of which there is not always a cure. Even when the treatment is optimal, there are often subjective complaints.Patients followed in Internal Medicine therefore have favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. This information will make it possible to target the patient's needs, and to be able to offer alternative medicines that are better focused, without calling into question their conventional treatment

Eligibility Criteria:
Inclusion criteria:

* Patient with systemic lupus erythematosus (ARA and/or SLICC criteria) OR with primary Sjögren's syndrome (revised Americano European criteria) OR with systemic scleroderma (ACR/EULAR 2012 criteria)
* Patient with signed consent

Exclusion criteria:

* Patients deprived of their liberty
* Minors and adults subject to legal protection measures
* Patients subject to a justice safeguard measure
* Patient unable to understand or adhere to the protocol
Effect of Different Nasotracheal Tubes on Tube Passage

The purpose of the study is to find out the clinical effects that can be obtained during nasotracheal intubation when using velvet-soft PVC tube compared to conventional polyvinylchloride(=PVC) tube.

The hypothesis of this study is that the velvet-soft PVC tube can advanced from the nasal cavity to the oral cavity through the posterior wall of the pharynx more smoothly than conventional PVC tube, thus reducing blockade of tube advancement, nasal/pharyngeal mucosal bleeding, and intubation time. In addition, investigators would like to compare the technique of nasal intubation using by connecting rubber suction catheter to PVC tube tip.

Eligibility Criteria:
Inclusion Criteria:

* The patients who need to nasotracheal intubation for surgery
* age: 19 years old or more

Exclusion Criteria:

* patient refusal
* nasal deformity
* history of previous moderate degree of epistaxis
Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus

Investigators will be determining whether a once weekly injectable medication Bydureon versus placebo is able to reduce the development of atherosclerosis.

Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis plaque progression in type 2 diabetes mellitus (T2DM). Investigators anticipate these studies will provide novel information about the temporal relationship between Bydureon induced changes in risk factors, endothelial function and atherosclerosis progression.

148 typical T2DM patients (ages 21-75) will participate in a rolling recruitment over approximately 2.25 years and be randomly allocated for 18 months to Bydureon (2 mg/week) or matching placebo subcutaneous injections 1x/week in a 2:1 ratio. Participants are expected to have a wide range of cardiovascular (CVD) risk and will therefore allow us to explore the importance of disease extent at baseline as a predictor of response. Blocked randomization will be used to ensure equal distribution of gender and CVD history. Carotid plaque MRI assessments will be performed at baseline, 9 and 18 months.

Eligibility Criteria:
Inclusion Criteria:

* males and females of any race and ethnicity with T2DM, HbA1c of ≥6.5% and ≤10.0% on diet only
* take stable doses of oral antihyperglycemic agents with or without long-acting insulin
* must have a regular primary care provider (PCP) that is amenable to patient study participation and will facilitate (blinded to the treatment) the research team's study protocol efforts

Exclusion Criteria:

* type 1 diabetes mellitus (T1DM)
* current or recent glucagon-like peptide 1 receptor (GLP-1R) agonist use
* contraindications to MRI (e.g., claustrophobia, ferromagnetic materials, body habitus inappropriate for MRI exam)
* screening carotid ultrasound plaque thickness of \<0.75 mm, prior or anticipated carotid stenting or endarterectomy
* recent CVD (past 6 months) or other major illness or conditions affecting risk (e.g., pancreatitis, severe renal disease) or personal or family history of medullary thyroid carcinoma
* patients with Multiple Endocrine Neoplasia syndrome type 2
* serious hypersensitivity to exenatide or any product components
* severe gastrointestinal disease, or pregnancy
Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype

The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of two CES1 dependent drugs, enalapril and methylphenidate.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Caucasian

Exclusion Criteria:

* Chronic disease (except hay fever and eczema)
* Pregnancy
* Smoking
* High level of alcohol consumption (\> 21 units per week for men and 14 for women)
* Known allergy towards methylphenidate and enalapril
* Permanent use of medication (contraception ok)
Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract

The Optical Coherence Tomography is a minimally-invasive diagnostic tool in both the office and operating room settings can identify sources of airway obstruction and effective surgical interventions. The researcher can use Optical Coherence Tomography to image tissues of the aero-digestive tract during surgical endoscopy in to the nose, oral cavity, larynx and ear in an outpatient clinic setting.

The Optical Coherence Tomography imaging system has low power non-laser broad band infrared light shine onto laryngeal, esophageal, tracheal, oral, nasal and ear tissue and does not involve input of significant amounts of energy and no temperature rise occurs.

The gradual development and acceptance of Optical Coherence Tomography as an imaging modality serves as an alternative to invasive tissue biopsy as a diagnostic measure. Imaging diagnosis, can implement and more convenient than tissue biopsy and can reduce procedural complications.

Eligibility Criteria:
Inclusion Criteria:

* Male and female age from new born to all age

Exclusion Criteria:

* subject who do not sign consent form
The Reliable Nutritional Risk Screening Tools

* assess the subjective global validity and reliability of using The Pediatric Yorkhil Malnutrition Score (PYMs) and merits of using the Screening Tool for Risk on Nutritional status and Growth (STRONGkids) as a nutrition screening tool
* correlate it with the severity of their nutritional derangements in comparison to the Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP)in hospitalized Egyptian children aged (2-5)years in Assiut University Children Hospital (AUCH).

Malnutrition is responsible for around 3.1 million child deaths annually in low and middle income countries,the malnutrition is involved in about 45% of under-five children deaths in numerous developing countries.

Malnutrition is associated with negative outcomes for inpatients, including increased risks of infections , increased muscle loss , impaired wound healing, longer hospital stay and increased morbidity and mortality .

Malnutrition may be responsible for delayed recovery and need for intensive nursing care, thus increasing the cost of hospitalization .

Nutritional support for inpatients has made progress and it is provided systematically through multidisciplinary nutritional support teams (NSTs) in most hospitals. The first step to run and manage the NST effectively and efficiently in each hospital may be proper screening and selection of the patients who are at risk of malnutrition requiring nutritional support during hospitalization Routine nutritional screening is rarely carried out in pediatric patients because of the lack of a simple and properly validated nutritional screening tool. The current practice of identifying children at risk of malnutrition is reliant on interpretation of anthropometric data and clinical judgement; the reliability of which is dependent on nutritional knowledge of pediatricians .

Severe cases of malnutrition are easily recognized; however, the identification of children with lesser degrees of malnutrition or at risk of malnutrition, which is also important, is not as easily achieved.

Eligibility Criteria:
Inclusion Criteria:

* all patients at the age of 2-5 years admitted in Assiut university children's hospital

Exclusion Criteria:

* no
Evaluation of STARgraft-3 for Hemodialysis

This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection.

This study is an extension from prior studies with STARgraft AV (NCT03916731) and STARgraft-2 (NCT04783779) investigational devices. A previous study also included control implants of commercially available standard ePTFE grafts approved for the same use.

The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to evaluate the performance of the investigational STARgraft-3 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year.

Estimated enrollment is 15 subjects in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, \> 18 years or age.
2. Patient has given informed consent to participate in the trial.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Able to effectively communicate with study personnel.
5. Candidate for a new arterio-venous graft placed in the upper arm.
6. Life expectancy judged to be at least 2 years.
7. Axillary vein of greater than or equal to 7 mm in diameter.
8. Brachial artery of greater than or equal to 4 mm in diameter.
9. Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, Ejection Fraction ≥ 40%)
10. Systolic blood pressure equal to or greater than 120 mmHg.
11. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.

Exclusion Criteria:

1. Unable or unlikely to comply with trial protocol and/or follow-up.
2. Pregnancy.
3. Clinically morbid obesity.
4. Anatomical limitations.
5. Immunodeficiency syndrome.
6. History of bacterial infection within 8 weeks prior to graft implantation.
7. History of hypercoagulation or bleeding disorders.
8. Elevated platelet count \> 1 million per microliter of blood.
9. History of heparin-induced thrombocytopenia syndrome (HIT).
10. Medically confirmed stenosis of the veins downstream of the implant site.
11. Inadequate arterial flow or pressure proximal to the implant site.
12. Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial.
13. Fever greater than 38°C.
14. Prior allergic reaction to silicone.
15. Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms.
An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain

This study is an open-label, multicenter, extension study for subjects who completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7days) before entry into Study C114


Eligibility Criteria:
Key Eligibility Criteria:

* Must have completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7 days) before entry into Study C114.
* Demonstrated adherence to protocol requirements during Study C111, and willing and able to comply with protocol requirements for the duration of the study participation.
* Must not have had any serious adverse experience since enrollment in Study C111, whether or not considered to be study drug-related.
* Must have intact skin at the treatment area.
* Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (36 weeks).
* Must not use topical pain medications on painful areas.
* Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed.
* No history or current problem with substance abuse.
Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis

The primary purpose of this study is to compare the efficacy of enteral nutrition compared to steroids in inducing remission of active pediatric Crohn's disease. The main hypothesis of this study is that the use of enteral nutrition induces mucosal healing, whereas steroids do not. This effect may be related to a change of the commensal flora during enteral nutrition.

The precise and exact cause of Crohn's disease (CD) remains still unknown. However, recent data point out to an inappropriate and exaggerated inflammatory response of the intestinal mucosal immune system toward intestinal commensal flora as initial trigger. Several strategies were developed in the treatment of active CD. Anti-inflammatory drugs such as steroids proved to be very helpful in the induction of a primary remission as is the use of exclusive enteral nutrition. Besides a long standing experience with EN in the management of CD in several centres, the mode of action and the molecular mechanisms of a specific EN, such as Modulen IBD ® remain still unknown. The ultimate aim of this study is to compare the efficacy of Modulen IBD ® in inducing remission compared to steroids with a detailed analysis of the mucosal repair and anti-bacterial defence mechanisms within the inflamed intestinal mucosa and the composition of the commensal flora before and during therapy. This approach may help to elucidate the interaction between the intestinal mucosa and the commensal flora during the onset of CD and induction of remission.

Eligibility Criteria:
Inclusion Criteria:

Crohn's disease active disease small bowel involvement

Exclusion Criteria:

antibiotic therapy within 4 weeks prior to inclusion immunosuppressive therapy within 4 weeks prior to inclusion not willing to collaborate isolated oral or perianal involvement
Comparison Trial of White Light, Autofluorescence and Narrow Band Imaging Bronchoscopy

The purpose of the study is to compare the three methods of bronchoscopic imaging to determine what combination is optimum to identify neoplastic mucosal abnormalities. The ability to decrease the rate of false-positive and false negative findings of bronchoscopy also will be studied for each spectroscopic technique separately and for their combination.

Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will be invited to participate in the study. All patients must be over 18 years old and must sign informed consent. The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope (11004BI; Karl Storz; Culver City, CA) and the flexible white light video-bronchoscope (BF-T180; Olympus; Center Valley, PA).

Images obtained will be photographed using both video recordings and parallel images of white light and imaged bronchoscopy. These digital images will be electronically stored and evaluated at a later time. Biopsies will be obtained of all suspected abnormalities. These will be correlated with the images.

Images will be identified as normal, suspect or abnormal based upon each modality independently, paired with the spectral image and all three combined. The control will be an area considered normal by all modes of bronchoscopy. Images will be graded at the time of bronchoscopy. Later, all images will be graded in a blind fashion by two independent bronchoscopists. Standard statistical analysis using paired Student's t test will be applied. We anticipate that the combination of one or more imaged bronchoscopy techniques will increase accuracy by 25%. Power calculation to detect such a difference will require 140 abnormal specimens. If 50% of patients examined have an abnormality, the study population will need to be around 300 patients.

Histopathology reports will be obtained on all specimens. Abnormal results will be discussed with the individual patient and appropriate procedures will be performed based upon best medical practices. These procedures and patient follow-up are beyond the scope of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lung abnormalities that have an indication for bronchoscopy

Exclusion Criteria:

* Inability to tolerate bronchoscopy
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets

For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. For society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.

This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:

* Arm 1: intramyometrial Terlipressin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
* Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
* Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure without using haemostatic tourniquets Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computergenerated randomization table with a 1:1:1 group allocation

Eligibility Criteria:
Inclusion Criteri

* Women aged 16-45 yearsAppropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm)
* Baseline hemoglobin ≥9 g/dl
* No contra-indications to the use of glyopressin or carbitocin
* Myoma-related symptoms, such as pelvic pressure or pain,menorrhagia, or infertility
* Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks)

Exclusion Criteria

* Open myomectomy using mechanical tourniquet
* Previous myomectomy
* History of bleeding disorders
* Concurrent anticoagulation therapy
* History of Uncontrolled ischaemic heart disease
* Any pelvic abnormalities requiring concomitant surgery
* Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
* Inability to understand and provide written informed consent
Self-directed Video Versus Instructor-based Neonatal Resuscitation Training

The effect of a self directed video strategy will be compared to a face to face neonatal resuscitation training program. The hypothesis is that both strategies are equivalent.

The NRP is becoming more and more a self learning program followed by a written test and practical hands-on evaluation; but the way the practical skills are taught and practiced has not been uniformly determined.

The current strategies for teaching involve resuscitation instructors. There are several difficulties in the developing world to achieve the objective of having a provider trained in neonatal resuscitation in every delivery. Part of this problem is due to the lack of instructors and-or budget constraint in addition to logistic difficulties.

Our Hypothesis is that a well developed self administered video complemented by a self practice using a mannequin will allow providers to reach at least similar performances on the initial steps and mask ventilation for neonatal resuscitation.

Objectives:

The aim of this study is to test the hypothesis that a self administrated video jointly with a mannequin give similar results than the current Neonatal Resuscitation Program (NRP), a pre-validated Objective Structured Clinical Examination (OSCE)hands-on course provided by a certified instructor.

Specific aim:

To compare the effectiveness of two different teaching strategies on the quality of the ventilation of a mannequin, using a mask by NAÏVE providers. In two different moments, approximately 15 minutes after having taken the course and at a mean of 3 months afterwards.

Two different groups of novice providers will be randomly selected to receive one of the following teaching strategies:

A. A Video based Self instruction with simultaneous video triggered practice with a mannequin without instructor feedback (Spanish in South America, English in North America) on initial steps and adequate mask ventilation for neonatal resuscitation.

B. A pre standardized hands on lesson will be offered by a NRP certified instructor followed by a debriefing session per a pre-validated OSCE protocol (current standard).

Afterwards, all the subjects will be invited to ventilate a mannequin with a standardized instruction (tbd for example...2 minutes ventilation, rate 40 to 60 and the necessary pressure to slightly reach chest rising). This performance will be digitally recorded.

Two independent certified instructors will evaluate the performance, blinded to the assigned group. A previously validated OSCE (objective structured clinical evaluation) performance evaluation grid will be used. The gold standard will consist on a high quality performance done by an NRP instructor.

Eligibility Criteria:
Inclusion Criteria:

* Medical Students from second year and above not previously trained in NRP (the Neonatal Resuscitation Program)
* Nursing Students from second year and above not previously trained in NRP
* Informed consent signed

Exclusion Criteria:

* previous experience in NRP