cyrilzakka/clinical-trials huggingface dataset:
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in Young Children in Turkey

The purpose of this study is to identify and characterize the bacteria causing complicated Acute Otitis Media episode in children \>= 3 months to \< 5 years in Turkey.


Eligibility Criteria:
Inclusion Criteria:

* Age: \>= 3 months and \< 5 years at the time they are seen by the paediatrician. The subject becomes ineligible on the fifth birthday.
* Signs, symptoms, and conditions:
* One of the functional or general signs of otalgia ,conjunctivitis, fever and either
* Paradise's criteria or
* Spontaneous otorrhoea of less than 24 hours.
* Subjects if classified as recurrent acute otitis media or treatment failure as described below:
* Recurrent acute otitis media: Defined as a subject who has an episode of acute otitis media representing the third new episode within the past 6 months, or the fourth new episode within the past year.
* Treatment failure: Defined as a subject who was diagnosed with acute otitis media and received antibiotic treatment from a physician, but is still symptomatic 48-72 hours after initiation of the treatment. As with other acute otitis media cases, the onset of signs or symptoms should have been within 72 hours prior to the initial visit to the physician.
* Written informed consent obtained from parent or guardian prior to study start.

Exclusion Criteria:

* Hospitalised during the diagnosis of acute otitis media or during treatment.
* Otitis externa, or otitis media with effusion.
* Presence of a transtympanic aerator.
* Systemic antibiotic treatment received for a disease other than acute otitis media in the 72 hours prior to enrolment.
* Receiving antimicrobial prophylaxis for recurrent acute otitis media.
* Provision of antibiotic by paediatrician at the enrolment visit prior to the sampling of the middle ear fluid or spontaneous otorrhoea.
* Patients that are on antibiotics for acute otitis media, and are clinically improving.
Artificial Intelligence in Colonic Polyp Detection

A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.


Eligibility Criteria:
Inclusion Criteria:

* All patients without IBD referred for colonoscopy

Exclusion Criteria:

* Age \< 40 years
* Not willing to participate
Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Dose

The investigators sought to investigate the efficacy of low frame rate (fluoroscopy at 7.5 frames per second (FPS) and Cine at 10 pulse per second (PPS) vs. conventional (15 FPS and 15 PPS) on radiation dose to the patient and the operator during coronary angiography and intervention. In addition, investigators sought to qualitatively assess the effect, if any, of the low frame rate on angiographic image quality.

Minimizing radiation exposure to patient and the operator is considered one of the primary safety concerns in the catheterization laboratory. Patients undergoing diagnostic angiography +/- ad hoc PCI or planned PCI, will be randomised to conventional settings (15 FPS and 15 PPS) or low frame rate settings (7.5 FPS and 15 PPS) or low Cine settings (7.5 FPS and 10 PPS). The patient radiation dose, patient radiation dose area product (DAP), and fluoroscopy time will be measured.

Statistical Analysis:

Demographic and procedural variables will be presented as percentage (categorical variable) or mean ± SD (continuous variable). Patients will be randomized into three arms - a control arm and two intervention arms. The angiographic radiation protocol will adhere to standard practice in both fluoroscopy and cine images at 15 frames/second. The intervention arm will consist of two groups. Group 1 with fluoroscopy images set at 7.5 frames/second and cine images set at 15 frames/second and group 2 with fluoroscopy set at 7.5 frames/second and cine set at 10 frames/second.

Sample size calculations are based on assuming a reduction in radiation dose in group 1 of 10% and in group 2 of 20%. At 5% significance and 80% power, a sample size of 200 patients will be required in each intervention arm. Allowing for a 10% attrition rate, a sample size of 220 patients will be required in each intervention arm with 100 patients in the control arm.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective or urgent cardiac catheterisation with or without ad-hoc PCI or planned PCI in the pre-specified catheterisation laboratories.

Exclusion Criteria:

* Patients who undergo procedures other than diagnostic coronary angiography or intervention (e.g. electrophysiological procedures).
* Patients participating in other research study requiring higher cine angiography.
* ST-elevation Myocardial Infarction
Sodium Oxybate Versus Midazolam for Comfort Sedation

The study aims at deepen the proof level of sodium oxybate use for comfort sedation at the end of life in a palliative care unit by comparing it to midazolam in a prospective randomized study with blinded efficacy evaluation. The study will be carried out for a period of 24 months with a recruitment objective of 22 patients with refractory suffering and with a short-term prognosis.

In certain cases, terminally-ill patients may show persistent symptoms despite numerous efforts to find a comfort treatment without causing impaired consciousness. In these cases and after a collegial discussion, sedation may be offered.

Midazolam is then the most typically used sedative agent. However, it has limitations: frequent awakenings, tolerance and major respiratory depression. Furthermore, the use of midazolam as a "gold standard" in palliative sedation at the end of life falls under expert consensus without a high level of evidence.

Sodium oxybate (GammaOH®), is an ancient molecule used in anesthesia and other medical fields. It appears to be an attractive alternative to midazolam. Study hypothesis is as follows: deep sedation induced by sodium oxybate (RASS: -4 or -5) is more constant and sustainable than by using midazolam which can cause fluctuating effects and requires frequent dosage adjustments. The single-blind clinical trial aims at comparing the possibility to obtain constant deep sedation using midazolam or sodium oxybate. Before the induction, the patient is not aware of the medication used. The medical team must be aware of it because the two administration procedures are too different.

Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized in a palliative care unit
* patient aged 18 or over
* patient with an estimated vital prognosis of a few hours to a few days\*
* patient with persistent suffering despite optimal palliative care\*
* patient gave informed consent in advance or if unable to do so, consent given by a family member or legal representative (patients under guardianship)
* patient covered by a social security scheme. \* Validated after collegial and multidisciplinary discussion including the opinion of a doctor outside the palliative care team.

Exclusion Criteria:

* contraindication or known allergy to sodium oxybate or midazolam
* significant risk of seizure
* venous access not possible
* pregnancy or breastfeeding
* person in exclusion period from another research protocol at the time of consent signing
* any condition which in the investigator's opinion could increase and jeopardize persons safety in case of research participation
Study of Blood Immune Cells in Cancer Patients Compared to Controls

Tumors have a systemic immune modifying effect. They affect the immune system similarly to states of chronic inflammation and these effects can:

* be monitored through analysis of nk t and myeloid cells mainly through studies of the zeta chain but also through other means
* may be decreased following effective anticancer therapy - may even be used to study the effectiveness of anticancer therapy
* are important to monitor if the investigators plan on formulation of systemic immune therapy Thus immumonitoring of systemic blood cells may turn out to be an important prognostic and predictive factor in many cancer types

CD247 Known also as the zeta chain is important for relaying T-cell induced signal transduction.

Interestingly studies by Baniash and others have demonstrated that this chain is down regulated in states of chronic inflammation and cancer in peripheral blood T cells and also in NK cells However there has not been a prospective study of this marker in cancer and control patients such a study will reveal not only the levels of CD247 in immune cells of cancer patients compared to controls but may reveal the effect of anticancer therapies on CD247 in cancer patients such a study may contribute significantly to our ability to monitor systemic immune system characteristics in cancer patients and help in any further studies of immunomodulation such as vaccination schemes in such patients

Eligibility Criteria:
Inclusion Criteria:

* patients with cancer or blood donators agreeing to participate in the trial

Exclusion Criteria:

* other disease states which may cause chronic inflammation
Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery

The purpose of this study is to evaluate the latency period (timing between the injection of the local anesthetic and the onset of complete sensory nerve block) of two approaches for ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned nerve. Our main hypothesis is that the first approach will decrease the latency period, and probably, will increase the success rate of the nerve block as well as patient satisfaction.

Compare the effectiveness of nerve blockade at the bifurcation site of the sciatic nerve versus distal (tibial and peroneal) using only levobupivacaine 0.5%. The primary outcome is the latency period of the nerve blockade; the secondary outcomes are rate of success of the procedure as well as patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for ankle or foot surgery at Hospital Pablo Tobón Uribe and Clínica CES.
* Physical status classification of the American Society of Anesthesiologists (ASA) 1-3.
* Age: 18-70 years.
* Weight: 40-100 kg
* Taller than 140 cm.

Exclusion Criteria:

* No patient acceptance.
* Contraindications for nerve block (coagulopathy, local anesthetics allergy, sepsis, infection at the site of puncture).
* Neuropathy or myopathy affecting the lower limb.
* Psychiatric or neurological diseases that alter the evaluation of patient.
* Arrhythmias.
* Heart failure.
* Diabetes Mellitus.
* Pregnancy.
* Language barriers.
* Anticoagulation.
Evaluation of the Influence of Output on Skin Covered by Adhesives

The study investigates the impact real output has on peristomal skin covered by two different adhesives


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have had an ileostomy for more than one year
* Have intact skin on the area used in the evaluation
* Has an ileostomy with a diameter up to 35 mm
* Have a peristomal area accessible for application of adhesive strips

Exclusion Criteria:

* Currently receiving or have within the past 2 month received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
* Are pregnant or breastfeeding
* Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
* Participating in other interventional clinical investigations or have previously participated in this evaluation -
Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis

Study objectives:

* To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis
* To assess the impact of tobacco discontinuation
* Study Design Multicentric prospective cohort study
* Main endpoint: Pulmonary deterioration
* Sample size : 40 patients

Study objectives To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis To assess the impact of tobacco discontinuation Study Design Multicentric prospective cohort study Main endpoint: Pulmonary deterioration Sample size : 40 patients

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary Langerhans cell histiocytosis diagnosed within the past 48 months

Exclusion Criteria:

* Age \< 18
* Deep pulmonary dysfunction (CPT\< 60%, FEV1\< 30%, DLCO\< 30%, partial pressure of oxygen in arterial blood (PaO2)\< 60mmHg)
* No informed consent or consent withdrawal
Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

This study aims to evaluate characteristics of patients with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer) including age, atopy status, previous allergic reactions, previous medical history, current medications and co-morbidities. Furthermore, symptoms on reaction such as severity grade of reaction will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Participants from 16 years of age and older with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer).

Exclusion Criteria:

* No previous hypersensitivity reaction to iron preparations or reactions to oral iron preparations.
* If a rejection to use patient data is documented in patient records, the patient will be excluded from analysis.
Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy

The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.

Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia , postoperative complications, pain score and duration of operation time will record.

Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.

Material and methods : Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia : abdominal discomfortable, shoulder pain, abdominal pain, nausea, anxiety, dermatomal level of sensory blockade, respiratory depression. We compare between two group; shoulder pain, postoperative complications, pain score, duration of operation time and length of hospital stay.

Fifty patients will select prospectively for LC, under low pressure (10 mm Hg) pneumoperitoneum and under combined anesthesia and general anesthesia. Spinal anaesthesia was performed at L1-L2 interspace using 2 ml of 0.5% (10 mg) hyperbaric Bupivacaine mixed with 0.5ml (25 micrograms) of Fentanyl. Epidural catheter was inserted at L1- L2 interspace too.

Eligibility Criteria:
Inclusion Criteria:

* Gall stone disease, polyp

Exclusion Criteria:

* Gall bladder cancer
Effect of Macadamia Nut on Cardiometabolic Risk Factors

This research study will test the effects of macadamia nuts on adiposity, and traditional and emergent risk factors of cardiometabolic disease in adult men and women

Purpose of this study is to investigate the effects of Macadamia nuts on body weight, adiposity, , oxidative stress, glucose, insulin an lipid levels. it will a randomized cross over study that will include two study diets (Macadamia nut diet and control diet) with a wash out period of 4 weeks in between. 40 subjects will be selected and randomized into either of the two phases. During the Macadamia nut diet phase subjects will be provided the appropriate portion of Macadamia nuts (15% of daily calories or 30-45 grams based on kcal requirement of the individual, instructions will be provided on how to incorporate nuts into the diet. this phase will last for 8 weeks. During the control diet phase, subjects will continue with their normal diet and abstain from eating nuts. subjects will be tested for various outcomes at baseline and twice at the end of each phase. The intervention will last for 5 months in total.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and post-menopausal women
* Overweight (BMI 25-\<40)
* Waist circumference ≥88.9 cm for women and ≥101.6 cm for men
* At least one of the following within the past year:
* Plasma triglycerides ≥150mg/dl
* Blood Pressure ≥130/85 mmHg or participants taking Antihypertensive medication
* Fasting glucose ≥100 mg/dL
* Low Density Lipoproteins\>= 130 mg/dl

Exclusion Criteria:

* Nut allergy, any
* Significant chronic disease including: diabetes, congestive heart failure, renal failure, cirrhosis, or autoimmune disease
* Medications affecting lipid or glucose metabolism, immune modulators, or antibiotics in the last 6 months
* Mega-doses of lipid-lowering dietary supplements in the last 6 months
* Cancer in the last 10 years (with the exception on non-melanoma skin cancer)
* Pregnancy or lactation
* Weight change of \>10% of body weight in the last 3 months.
* Tobacco use
* Claustrophobia (may affect BOD POD testing)
Validation of Venogenic Hypothesis for Cough, Exertional and Sexual Headaches

Clinical and neuroradiologic study concerning patients suffering of cough, exertional and sexual headaches disorders (pathophysiology) concerning a venous hypothesis implication, redescribe clinical headaches specifications, confirmed if cough headaches is a clinical entity and if it has neuroradiologic differences with effort or sexual activity headaches.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering of headache disorders

Exclusion Criteria:

* none
Clinical Application of MDCT in Coronary Artery Disease

1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of coronary CT angiography and the influence of coronary calcium score on coronary CT angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.

Computed tomography is evolving as a tool for noninvasive diagnosis of coronary artery disease. Coronary calcium deposition amount is an established independent coronary artery disease risk factor. However, coronary artery stenosis seldom occurred in the same location as calcium deposition. With the advent of 16-detector-row multislice spiral CT, direct visualization of coronary artery is possible. But it remains a great challenge to obtain diagnostic quality image in the beating heart. Small distal vessels may not be adequately visualized. Artifacts from severe calcification or coronary stent may render diagnosis difficult. The clinical implication of coronary calcium score, indication of coronary CT angiography and myocardial enhancement measurement should be further studied. The purposes of this study are: 1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of coronary CT angiography and the influence of coronary calcium score on coronary CT angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease admitted for coronary angiography

Exclusion Criteria:

* Heart failure, irregular heart rate
Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea

The aim of this study is to investigate the effects of topical herbal medicine in the patients with rosacea.

Rosacea is a chronic inflammatory disorder which affects the cheek, nose, chin, forehead and eyes. It is typically characterized by cutaneous signs such as flushing, erythema, telangiectasia, papules, and pustules in the face. The pathogenic mechanism of rosacea is unknown, and there is no cure for rosacea. The therapeutic approaches include oral medicine, topical medicine and surgical interventions depending on the different subtypes of rosacea. The recent study demonstrates that combination therapy may be more effectively improved the symptoms of rosacea. Dian dao san is a topical herbal compound for reducing the features as flushing, erythema, papules, and pustules for years. The investigators hypothesize that dian dao san can be more beneficial in treating the patients with rosacea and improving the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign inform consent
* Aged above 20 years old with rosacea
* No treatment for rosacea within 2 weeks

Exclusion Criteria:

* With malignant lesion in the rosacea lesion
* Rosacea lesion with high risk of infection
* Allergy to Chinese herbal medicine patch or ointment
* Pregnancy
Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.

The study is a thirty three week, prospective, open-label, randomized, parallel-group non-inferiority study.

The study aims to investigate the Substantial Equivalence of a novel mandibular device called iSlpr™, produced by BioAnalytics, to a currently approved device, SomnoDent® Classic, in the treatment of mild to moderate Obstructive Sleep Apnoea (OSA) and snoring.

The objective of this study is to determine if the BioAnalytics device, iSlpr™, has a similar safety and efficacy profile to a commonly used device, SomnoDent® Classic, in the treatment of snoring and mild to moderate Obstructive Sleep Apnoea.

The target population will be males and females aged from 18 years to less than 75 years, who have been diagnosed with snoring and mild to moderate sleep apnoea.

Participants will remain on study from screening visit to end of study visit; a total of approximately 33 weeks.

This study includes -

* a screening period of up to 28 days
* a 2 week device initiation period
* a 24 week treatment period

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older and younger than 75 years at time of screening
* Snoring and mild to moderate sleep apnoea ( AHI \> 5 and \< 30 per hr)
* Written informed consent
* Able to complete the study procedures within the study timeline.

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Central sleep apnoea
* Severe respiratory disorders
* Loose teeth or advanced periodontal disease
* Lateral bruxers
* Full or partial dentures
* Temporomandibular Joint (TMJ) abnormalities, pain or dysfunction
* Other teeth, jaw or gum disorders would preclude use of the device
* Cardiovascular comorbidities or stroke/heart attack in past 12 months
* Drug-addiction
* Major Depressive Disorder or psychosis
* Undergoing concomitant therapy for OSA/Snoring
* current or previous therapy with SomnoDent Classic
* Professional drivers or machine operators required to be undertaking CPAP