cyrilzakka/clinical-trials huggingface dataset:
Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia

The project Visceral Leishmaniasis and Malnutrition is a cohort study that aimed to assess the association between malnutrition and visceral leishmaniasis (VL). It was conducted in Libo Kemkem and Fogera districts of the Amhara Regional State in Ethiopia. Clinical, anthropometric, biochemical, immunological, parasitological and sociodemographic data of school age children from VL high prevalence communities were collected in December 2009, May 2010 and February 2011.


Eligibility Criteria:
Inclusion Criteria:

* Reported age between 4 and 15 years of age
* Currently living in the selected household

Exclusion Criteria:

* To be ill of visceral leishmaniasis at the time of the survey
* To be positive to visceral leishmaniasis infection tests at the time of the first survey
* To be under treatment for visceral leishmaniasis at the time of the survey
* To be extremely ill of any other condition
A Comparison of Video Laryngoscopes and the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway.

In Pediatric both manikin and human studies have suggested that the video laryngoscopy is equally suitable to facilitate intubation compared to the direct laryngoscopy.

The King Vision Pediatric aBlade is a novel video laryngoscopy for securing the airway of new born and infants. In this manikin studie we want to compare different types of video laryngoscopes in a simulated normal and difficult infant airway.

Eligibility Criteria:
Inclusion Criteria:

- anesthesiologists or neonatal/pediatric intensive care medicice specialists with experience in securing pediatric airway

Exclusion Criteria:

- participants without experience in pediatric airway management
Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers

The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.

This is a multi-centre study on 60 patients who have a lower limb ulcer.


Eligibility Criteria:
Inclusion Criteria:

* patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (\> 10 cm²)
* patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis.
* not eligible for skin flap surgery,
* the patient or patient's representative has agreed to sign the information letter before any investigation required by the research.

Exclusion Criteria:

* circumferential wound,
* wound infection
* immunosuppressed patient,
* known allergy to bovine collagen, bovine glycosaminoglycans or silicone,
* patients under legal guardianship,
* pregnant women
* patients whose health would compromise follow-up for at least 18 months,
* patients whose mental health would compromise completion of the self-evaluation questionnaires.
* wound located in an area not visible by the patient (as no self-assessment would be possible).
Comparıson Of Sılıcone And Acrylıc Medıcal Adhesıve Tapes On Skın İnjury Nasogastrıc Tube

This randomized controlled experimental study was conducted to compare the effects of silicone and acrylic medical adhesive tapes on medical-adhesive related skin injury in the fixation of nasogastric tubes in patients being monitored in intensive care.

This randomized controlled experimental study was conducted to compare the effects of silicone and acrylic medical adhesive tapes on medical-adhesive related skin injury in the fixation of nasogastric tubes in patients being monitored in intensive care.

The population of the research consisted of patients with nasogastric tubes who were hospitalized in the Neurology Intensive Care Unit of Ege University Hospital (Health Practice and Research Center) between the dates of 01.06.2022 and 31.12.2023. The sample of the study consisted of 76 patients who were hospitalized in the Neurology Intensive Care Unit during this date range, had a nasogastric tube inserted, complied with the limitations of the study and agreed to participate in the study. Patients were stratified according to their age groups and assigned to experimental and control groups by block randomisation technique.

The nasogastric tube of the patients in the control group was fixed with acrylic medical adhesive tape which is used in routine practice, and the nasogastric tube of the patients in the experimental group was fixed with silicone medical adhesive tape. Starting from these condday following the nasogastric tube insertion, the medical adhesive tape that enables the fixation of the nasogastric tube was removed by wetting it with a sterile tampon impregnated with distilled water, and the patient's nasal skin was observed for 10 minutes each time, during 7 days for the presence of erythema, edema, denudation, dryness, infection, and vesicles. Then, the same medical adhesive tape was applied again and the tube was fixed. The data were analyzed in SPSS 25.0 program. Mann-Whitney U test, Pearson Chi-square test and Fisher's Exact probability test were used to analyze the data. The nasogastric tube of the patients in the control group was fixed with acrylic medical adhesive tape which is used in routine practice, and the nasogastric tube of the patients in the experimental group was fixed with silicone medical adhesive tape.

Eligibility Criteria:
Inclusion Criteria:

* Feeding with a nasogastric tube
* Being between the ages of 18-85
* Voluntarily participating in the study
* Having the first nasogastric tube inserted after admission to the Intensive Care Unit and having the tube detected by the researcher.

Exclusion Criteria:

* Having any dermatological disease
* Having a history of allergy
* Having a lesion on the skin of the nose
* Failure to detect the tube by the researcher when the first nasogastric tube was inserted after admission to the Intensive Care Unit.
Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety and efficacy of different dosage of Nimotuzumab in second or late- line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinomas.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed esophageal squamous carcinoma,failed to first or second line chemothrepay
* Age 18 to 75 years old
* Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
* Life expectancy of ≥3 month
* Karnofsky performance status ≥80
* WBC\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>100,000/mm3, Hb\>9g/dl，Bilirubin level \< 1.0 times ULN，Serum creatinine \<1.0 times ULN，ALT and AST\<2.5 times ULN ，AKP \< 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃；
* Normal ECG/cardiac function
* Good compliance
* Having signed informed consent -

Exclusion Criteria:

* No previous systemic therapy for metastatic esophageal squamous carcinoma
* Known hypersensitivity to study drugs
* Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
* No measurable lesions, eg. pleural fluid and ascites
* Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
* Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
* Chronic diarrhea
* Mentally abnormal or disable cognition,including CNS metastasis
* Pregnancy or lactation period
Vaccination Against SARS-Cov2 (COVID-19) in Chronic Inflammatory Rheumatism and Factors Determining Its Decision.

Rheumatoid arthritis and spondyloarthritis (ankylosing spondylitis and psoriatic arthritis mainly) are chronic inflammatory rheumatism (RIC), frequently onset in young adults. The prevalence is respectively 0.3 to 0.8% and 0.4%. or about 600,000 people. The "basic" treatments (DMARDs), essential to control the progression of the disease, are classified into csDMARDs (chemical), the first of which is methotrexate, or bDMARDs (biological). These treatments are immunomodulators and there is an increased risk of severe infection under these therapies. Several vaccinations are therefore recommended by learned societies in patients receiving these treatments, in order to prevent certain infectious risks.In the current pandemic context, the vaccination of these patients against SARS-Cov2 is a major issue in their management and is recommended by the French society of rheumatology. However, many patients express doubts about this vaccination or refuse it. The factors associated with the vaccination will are not known. Better identifying them would make it possible to adapt the information to be given to our patients to promote their adherence.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients
* Men or women of any age
* Follow-ups for chronic inflammatory rheumatism such as rheumatoid arthritis or spondyloarthritis
* Treated with methotrexate or biotherapy.

Exclusion Criteria:

* Patients not treated with biotherapy or methotrexate.
* Patients in whom the assessment could not be performed reliably
Opioid Free Management After Ureteroscopy

The purpose of this research study is to compare how well two medications work to control post-operative pain.

This will be a randomized double blinded control trial with subjects randomized to either opioid group (Norco 5-325 milligram) or a non-opioid group (Ibuprofen 400 milligram). Subjects with a renal stones who are consented for a ureteroscopy will be eligible for the study. Subjects eligible for the study will have a discussion with the study team member about treatment options. Subjects can either elect not to be in the study and actively choose which treatment is preferable, or the subject can choose to enter the study and be randomized to one of these treatment arms. The ureteroscopy will be performed using standard of care instruments and techniques. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. Post operatively; investigators plan to discharge all subjects home from the recovery unit. All subjects will be seen one week after surgery for follow up, questioner filling and stent removal.

Eligibility Criteria:
Inclusion Criteria:

* Ureteroscopy performed for renal stones
* Age over 18 years
* Two kidneys

Exclusion Criteria:

* Solitary Kidney
* Poor kidney function (GFR\<30)
* Allergy to either Ibuprofen or Norco
* Pelvic Kidney
Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse

The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* Severe primary mitral regurgitation (grade 3+ or 4+)
* Class I indication for MV Surgery according to ESC/EACTS and AHA/ACC guidelines:

  1. Symptomatic patients and/or
  2. LV (Left Ventricular) dysfunction : LVESD ≥45 mm and/or 30≤ LVEF ≤60%
* Leaflet prolapse of P2 and/or A2
* Predicted coaptation length \> 4 mm
* Candidates for surgical mitral valve repair according to heart team
* Patient able to sign an informed consent form
* Patient benefiting from a social insurance system or a similar system

Exclusion Criteria:

* Asymptomatic patients with preserved LV function
* Complex mechanism of MR (leaflet perforation, severe calcifications, commissural extension, etc)
* Secondary MR
* Predicted post-repair coaptation length less than 4 mm
* Atrial fibrillation
* Inflammatory or infective valve disease
* Severe LV dilation (DTD \> 65 mm)
* Significant mitral annulus dilatation (D \> 45 mm)
* Surgical indication of tricuspid annulus
* Contraindication to TEE (transesophageal echocardiographic ) or inadequate image quality
* Need for any other concomitant cardiac procedure
* Concurrent medical condition with a life expectancy of less than 24 months
* Patient unable to understand the purpose of the trial
* Patient \< 18 years old
* Participation to another trial that would interfere with this trial
* Pregnancy
Evaluation of a Website to Improve Depression Literacy in Adoldescents

The aim of this study is to evaluate the efficacy and acceptability of the website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy (knowledge about depression, which aid the recognition, treatment or prevention of depression) in healthy adolescents. The investigators will examine whether the website improves depression literacy in healthy adolescents aged 12 to 18 years. The investigators will also assess the acceptability of the website among adolescents.

Few young people with major depressive disorder seek professional treatment in time. Concerns about social stigma, confidentiality, and limited knowledge about mental health conditions, such as depression, or mental health services are some of the main barriers to seek treatment. To address these problems, we developed an evidence-based website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy.

To improve depression literacy, the website provides general information about depression as psychiatric disorder in adolescents (e.g., symptoms, causes, course and treatment of depression). Furthermore, the website provides information about self-help strategies for depression and prevention of depression; i.e., strategies for promoting mental health (e.g., reducing stress, doing exercise, undertaking positive activities), which are meant to serve as an addition to professional treatments of depression or to promote mental health in adolescents.

Target groups of the website are adolescents aged 12 to 18 years seeking help for depression, as well as healthy adolescents seeking information about mental health promotion or depression. Easy access to information about depression would make early recognition of depression more likely and engage young people to seek help for depression.

Since the website targets two different groups, the investigators will evaluate the website accordingly:

Target group 1: Adolescents with a major depressive disorder (acute or remitted) Target group 2: Healthy Adolescents (no mental health condition) The current study will focus on target group 2. A study focusing on target group 1 can be found in a separately registered clinical trial on clinicaltrials.gov.

The primary aim of this study is to evaluate the efficacy and acceptability of the website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy in healthy adolescents.

Eligibility Criteria:
Inclusion Criteria:

- Intelligence quotient (IQ) of ≥ 80

Exclusion Criteria:

* Current diagnosis of a mental disorder
* Remitted depressive disorder
* Insufficient knowledge of German
Comparison of Pain Relief After Upper and Lower Lumbar Erector Spinae Plane Block

The primary endpoint of this study was to identify if eretor spinae plane block (ESPB) has any effect in relieving low back pain or leg pain in lumbar radiculopathy. The secondary endpoint was to compare the number of spread level when upper or lower lumbar ESPB was performed.

The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. However, these studies are limited by the small number of included patients. Therefore, the exact spread level of injected local anesthetics remains unclear and a study on a large number of patients is still required

Eligibility Criteria:
Inclusion Criteria:

* lumbar disc herniation
* lumbar foraminal stenosis
* lumbar central stenosis
* lumbar spondylolisthesis
* severe level of spine at L3-4
* numerical rating scale \> 4
* back pain functional scale \< 45
* duration of pain \> 1 month
* patients who can fully understand all items described in BPFS

Exclusion Criteria:

* Allergy to local anesthetics or contrast medium
* Pregnancy
* Spine deformity
* Prior history of lumbar spine surgery
* No previous lumbar MRI or CT
* Patients with coagulation abnormality
* Incorrect level of ESPB
Enamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients

The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of periodontal healing in diabetic patients.

Patients with periodontitis will be randomly allocated to two groups. In both groups, periodontal root instrumentation will be performed. In the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm.

Metabolic glucose control as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with diabetes mellitus type II and currently under treatment;
* No previous periodontal treatment in the last 6 months;
* Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non- adjacent teeth);
* Ability to understand the study procedures and comply with them through the length of the study.

Exclusion Criteria:

* Pregnancy and breast feeding;
* Need for antibiotic treatment during periodontal therapy;
* Chronic infections;
* Systemic diseases;
* Patients who report current smoking over 20 cigarettes per day.
Imaging and Treatment Planning for Cardiac Radioablation

The purpose of this study is to (1) determine whether computed tomography (CT) imaging can be used to identify areas of ischemic scar, which are often used as radiation targets for cardiac radioablation, just as well as MRI can, and (2) to determine how best to deliver cardiac radioablation treatment to a patient, for example, which treatment machine should be used and how to limit the effect of chest movement during treatment.

Participants will undergo two separate imaging appointments: one CT imaging appointment, where they will undergo scans including perfusion scans, late enhancement scans, and radiation therapy treatment planning scans; and one MRI appointment, where they will undergo scans including a late enhancement scan. The overlap in areas of ischemic scar as identified in CT scans and MRI scans will be quantified.

Using radiation therapy treatment planning CT scans, the safety and feasibility of different treatment and motion management techniques will be evaluated. Treatment plans will be created using these different techniques and will be compared to one another. These plans will also be evaluated for compliance with dose constraints.


Eligibility Criteria:
Inclusion Criteria

* Ischemic cardiomyopathy with monomorphic VT
* Referred by cardiologists
* 18 years of age or older Exclusion Criteria
* Polymorphic ventricular tachycardia
* Ventricular fibrillation
* Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study
* Estimated glomerular filtration rate ≤ 30 mL/min/1.73m2
* Unable to undergo MRI due to metal implants
* Previous allergic reaction to CT contrast agent
Treatment of Allergic Rhinitis and Chronic Polypous Rhinosinusitis With Olfactory Mucosa-derived Mesenchymal Stem Cells

Treatment of patients with allergic rhinitis and chronic polypous rhinosinusitis with olfactory mucosa-derived mesenchymal stem cells

During the implementation of the project, the methods for the treatment of allergic rhinitis and chronic polypous rhinosinusitis with olfactory mucosa-derived mesenchymal stem cells will be developed.

The positive outlook for the effectiveness of MSCs is due to the following:

* knowledge of the leading role of immunopathogenetic mechanisms in the development of allergic rhinitis and chronic polypous rhinosinusitis and the pronounced immunomodulating properties of MSCs;
* the ability of MSCs to reduce the production of proinflammatory cytokines and suppress immune inflammation;
* positive results of preclinical studies of the method of treatment of diseases accompanied by over-activation of the immune system, including autoimmune diseases, in animals and the first clinical studies in patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of allergic rhinitis or chronic polyposis rhinosinusitis
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent

Exclusion Criteria:

* The presence of any malignant tumor within the last 5 years
* Acute or chronic diseases in the stage of decompensation
* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
* Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
* Patients are unable or unwilling to give written informed consent and / or follow research procedures
* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study