cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Imaging Based on Ultrasound Bronchoscopy in Respiratory Diseases: a Retrospective, Single-center, Confirmatory Study

ABSTRACT Background and objective: To establish a ultrasound radiomics machine learning model based on endobronchial ultrasound (EBUS)to assistdoctors in distinguishing between benign and malignant diagnoses ofmediastinal and hilar lymph nodes.

Methods: The clinical and ultrasonic image data of 197 patients wereretrospectively analyzed. The radiomics features were extracted by EBUS.based radiomics and dimensionality reduction was performed on thesefeatures by the least absolute shrinkage and selection operator (LASSO)EBUS-based radiomics model was established by support vector machine(SVM).205 lesions were randomly divided into a training group (n=143)and a validation group (n=62). The diagnostic efficiency was evaluated byreceiver operating characteristic (ROC).Results: A total of 13 stable features with non-zero coefficients wereselected. The support vector machine (SV) model exhibited promisingperformance in both the training and verification groups. In the traininggroup, the SVM model achieved an area under the curve (AUC) of 0.892(95% CI: 0.885-0.899), with an accuracy of 85.3%, sensitivity of 93.2%and specificity of 79.8%.In the verification group, the SVM modeldemonstrated an AUC of 0.906 (95% C: 0.890-0.923),along with anaccuracy of 74.2%,sensitivity of 70.3%, and specificity of 74.1% Conclusion:EBUS-based radiomics model can be used to differentiatemediastinal and hilar benign and malignant lymph nodes. The SVM modeldemonstrates superiority and holds potential as a diagnostic tool in clinical practice


Eligibility Criteria:
Inclusion Criteria:

* (1)chest CT showing enlarged mediastinal or hilar lymph nodes or positive findings of mediastinal and hilar lymph nodes on PET/CT (SUV≥2.5); (2)patients who underwent EBUS-TBNA examination; (3)no contraindications for surgery.

Exclusion Criteria:

* (1)prior treatment of target lymph nodes before EBUS-TBNA; (2)unclear diagnostic results; (3)loss to follow-up.
Ivabradine for Prevention of Myocardial Injury After Noncardiac Surgery Trial (PREVENT-MINS)

This study is a multicentre, randomized controlled trial of ivabradine versus placebo.

The PREVENT-MINS study is a 2,500 patient multicentre, superiority randomized controlled trial of ivabradine versus placebo. The primary objective of the trial is to determine the impact of ivabradine versus placebo on the risk of MINS in patients with or at risk of atherosclerotic disease who are followed for 30 days after noncardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Undergoing noncardiac surgery
2. ≥45 years of age
3. Expected to require at least an overnight hospital admission after surgery
4. Provide written informed consent to participate in the PREVENT-MINS Trial, AND
5. Fulfill ≥1 of the following 5 criteria (A-E):

A. History of coronary artery disease B. History of peripheral arterial disease C. History of stroke D. Undergoing major vascular surgery, OR

E. Any 3 of 9 risk criteria:

i. Undergoing major surgery ii. History of congestive heart failure iii. History of a transient ischaemic attack iv. Diabetes and currently taking an oral hypoglycemic agent or insulin v. Age ≥70 years vi. History of hypertension vii. Serum creatinine \>175 µmol/L (\>2.0 mg/dl) viii. History of smoking within 2 years of surgery ix. Undergoing emergent/urgent surgery

Exclusion Criteria:

1. Conduction abnormalities:

   A. Non-sinus rhythm on ECG B. Sinoatrial or AV (2nd and 3d degree) blocks C. Sick sinus syndrome D. Long QT syndrome E. Pacemaker dependent
2. Transplanted heart (or on waiting list)
3. Use of a selected class I or III antiarrhythmic drug (quinidine, disopyramide, sotalol, ibutilide, amiodarone) or diltiazem/verapamil
4. Resting heart rate \<65 beats per minute on the day of surgery
5. Systolic blood pressure \<90 mmHg on the day of surgery
6. Acute decompensated heart failure, cardiogenic shock, acute myocarditis
7. Acute coronary syndrome within 2 months before surgery;
8. Stroke or transient cerebral ischaemia within 1 month before surgery
9. Known severe liver or kidney disease (MDRD creatinine clearance \<15 mL/min)
10. Inability to tolerate oral intake
11. Recent use of ivabradine (\<1 month)
12. Known allergy or hypersensitivity to ivabradine
13. Low-risk surgical procedure based on individual physician's judgment
14. Investigator considers the patient unreliable regarding requirement for study compliance
15. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
16. Previously enrolled in the PREVENT-MINS study
Secretin-enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) and Pancreatic Function Following Surgery

The aim of this study will be to determine whether secretin-enhanced MRCP (S-MRCP) as well as traditional magnetic resonance imaging (MRI) of the pancreas will allow the investigators to quantify the pancreas' ability to secrete hormones as well as digestive enzymes, both before and after surgery. The investigators hypothesize that S-MRCP will provide a novel non-invasive measure of pancreatic function.

Surgical resection offers the only hope of cure for pancreatic adenocarcinoma. While perioperative mortality rates have declined in recent years, pancreatectomy is still associated with significant postoperative malnutrition, maldigestion, and glucose intolerance, mostly as a result of pancreatic insufficiency. Quantifying residual pancreatic function remains a challenge, but is essential in improving the survival and quality of life of pancreatic cancer patients. Secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP)has recently emerged as a widely-accepted noninvasive technique to assess morphological changes in the pancreatic ducts, as well as functional secretory capacity of the gland. The aim of our study is to evaluate S-MRCP as a means to assess pancreatic reserve in patients who will undergoing surgical resection for pancreatic carcinoma. As an adjunct to S-MRCP, we will also evaluate the concomitant use of dynamic MRI with contrast enhancement. This will be a prospective study of twelve patients who will undergo S-MRCP/MRI within 30 days of surgery and then at 3, 6, and 12 months post-operatively. Quantitative analysis of S-MRCP will include pancreatic duct diameter and volume before and after secretin administration. MRI will be analyzed for mean T1 signal intensity, total parenchymal volume, and gadolinium enhancement. These radiological parameters will be compared to clinical parameters of exocrine function(subjective reporting of steatorrhea and abdominal pain as well as levels of fecal elastase1 and fat soluble vitamins in stool samples) as well as endocrine function (fasting blood glucose, hemoglobin A1c, amylin, glucagon, and somatostatin levels, as well as arginine-stimulated levels of islet cell hormones).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older.
* Tissue-confirmed diagnosis of pancreatic adenocarcinoma.
* Scheduled for surgical resection of the adenocarcinoma (Whipple or distal pancreatectomy).
* Able to give informed consent

Exclusion Criteria:

* History of any radiation therapy to the abdomen prior to surgery.
* Any contraindication to MRI, including but not limited to implanted metal devices (e.g. pacemaker, berry aneurysm clips, neural stimulator, cochlear implants, or metal in the eye).
* Treatment with an investigational drug within 1 month prior to the day of the study drug administration.
* Current enrollment in any other interventional study.
* Creatinine greater than 2.0.
* Significant liver disease, liver masses, or evidence of portal hypertension.
* Pregnancy.
* History of sensitivity to secretin.
* Unwilling or unable to sign informed consent.
Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients

The purpose of this study is to compare the efficacy and safety of intra-articular glucocorticoid injection to its systemic use for treatment of knee synovitis in patients with Rheumatoid Arthritis

A randomized double-blind controlled study was conducted including 60 patients with RA. Patients were randomized to receive either a single intra-articular knee injection with triamcinolone hexacetonide 60 mg and xylocaine chloride 2% (1 mL) associated to a single intramuscular injection of 1 mL of xylocaine chloride 2% (IAI group) or 1 mL of xylocaine chloride 2% by intra-articular injection and a intramuscular injection of triamcinolone acetonide 60 mg and xylocaine chloride 2% (1 mL) (IM group). Evaluations were performed at baseline and 1, 4, 8 and 12 weeks post-intervention. The following instruments were used: the ACR 20%, 50 and 70% improvement criteria; VAS for knee morning stiffness, pain and edema; knee circumference and goniometry; Likert's scale of improvement (IVAS); daily use of oral glucocorticoid and NSAIDs, blood pressure and adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid Arthritis diagnosed for more than 6 months
* 18 and 65 years
* Functional class II or III according to the ACR criteria
* VAS for knee pain higher than 5
* Use of stable doses of oral corticosteroid for the last 30 days
* Use of stable doses of DMARDs for the last 3 months
* Active synovitis at least in one knee for at least the 30 days

Exclusion Criteria:

* Non-controlled diabetes mellitus or hypertension
* Bacterial infection of any site
* Blood coagulation disorders
* Skin lesion on the affected knee
* History of previous surgical procedure in the knee
* Use of intra-muscular glucocorticoid in the last 30 days
* Intra-articular injection in the last 3 months
* Knee injection in the last 6 months
Bacterial Contamination on Obstetric Resident Surgical Scrubs

This study will determine if there is a difference in bacterial contamination (CFU/cm2) between obstetric resident surgical scrubs donned at home and those donned at the hospital.

An area of potential provider-to-patient contamination, and therefore intervention, is in health care worker attire and laundering practices. For providers who work in the operating room or labor \& delivery suites, this uniform usually comprises hospital-issued surgical scrubs. To the best of our knowledge, no study has measured the difference in bacterial contamination on surgical scrubs vis-a-vis the two variables most directly affected by hospital policies for surgical attire: site of scrub laundering and site where scrubs were first put on. In addition, no study has measured the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting. Our primary objective is to measure the difference in bacterial contamination (CFU/cm2) between home-laundered/home-donned scrubs ("home/home," group 1), hospital-laundered/home-donned scrubs ("hospital/home," group 2), home-laundered/hospital-donned scrubs ("home/hospital," group 3), and hospital-laundered/hospital-donned scrubs ("hospital/hospital," group 4) in the obstetric setting. Our secondary objective is to determine the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting.

Eligibility Criteria:
Inclusion Criteria:

* ob-gyn residents assigned to labor and delivery during the day on one of seven rotation blocks

Exclusion Criteria:

-
Bacterial Growth in Vascular Surgery Wounds

The amount and species of bacteria have been shown to have an effect in wound infections in several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery of facial area). In vascular surgery, wound infections are a common and expensive complication. The aim of the present study is to investigate the prevalence of bacteria in vascular surgery wounds perioperatively, and determine whether is correlates with the incidence of wound infections postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* need for lower limb vascular by-pass surgery

Exclusion Criteria:

* allergic to cefuroxime
* patients refusal to participate
A Prospective Natural History Study of Progression of Subjects With Duchenne Muscular Dystrophy.

To characterize the natural history and progression of Duchenne Muscular Dystrophy (DMD) to help inform the design of future studies, to capture biomarkers of safety and disease progression and to provide comparative data for the development of rare exons for which formal controlled trials are not feasible.

This is a prospective study. All DMD patients that fulfil the inclusion/exclusion criteria are eligible although the study is weighted towards ambulant subjects aged 3 years or older. There will be 7 study visits and subjects will be in the study for a maximum of 3 years. Visits will occur every 6 months (+/- 1 month).

Up to 250 DMD subjects planned in the following categories :

* 75 % ambulant subjects aged between 3 and 18 years at study entry
* 25% non-ambulant subjects with a maximum age of 18 years at study entry

Subjects will be asked to perform muscle testing assessment with a clinical evaluator, such as walking for 6 minutes, climb stairs, breathe in a tube, see how they can move their arms and legs. They will be asked questions about how they feel overall and perform daily activities. These measurements will be assessed every 6 months.

Urine and blood samples will be collected once a year to measure biomarkers that will allow to have a better overview of DMD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DMD resulting from a mutation in the DMD gene confirmed by a state of the art DNA diagnostic technique covering all DMD gene exons.
* Age 3 - 18 years
* Willing and able to comply with protocol requirements
* Life expectancy of at least 3 years
* Able to give informed assent and/or consent in writing signed by the subject and/or parent(s)/legal guardian (according to local regulations)

Exclusion Criteria:

* Current participation in a clinical study with an Investigational Medicinal Product (IMP)
* Participation within the previous 1 month in a clinical study with an IMP
Diabetic Retinopathy and Sickle Trait

To more clearly ascertain the relationship between ocular manifestations of sickle cell disease and diabetes, specifically; whether the presence of sickle cell trait exacerbates the disease progression of diabetic retinopathy.

The objective of this research study is to evaluate the relationship between sickle cell trait and the progression of diabetic retinopathy. People with diabetes have high blood sugar that damages small blood vessels. Damage to the blood vessels that supply the retina in the back of the eye is called diabetic retinopathy. Diabetic retinopathy is worse in African-Americans with diabetes, with earlier and more severe disease progression and common complications including vitreous hemorrhage - where these blood vessels in the eye leak - and retinal detachment - the separation of the nerves of the retina from the back of the eye which may lead to blindness. One explanation for this increased severity of diabetes in African-Americans is the presence of sickle cell disease, or even just sickle trait, which causes damage to red blood cells and blood vessels under conditions of stress; like low oxygen levels, or hyperglycemic acidosis.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified African-American patients with diabetes will be identified from Dr Bowie's retina clinic at Storm Eye Institute.
* These subjects are either being screened or treated for the progression of diabetic retinopathy.

Exclusion Criteria:

* None
Rapid and Accurate Detection of Major Mycobacterium Species in Pulmonary Infection Based on GenSeizer Platform

Comparison of rapid detection methods of mycobacterial pathogens, GenSeizer v.s. PCR reverse hybridization.

The investigators developed a new platform called GenSeizer, which combines bioinformatics analysis of a large dataset with multiplex PCR-based targeted gene sequencing, to identify eleven major Mycobacterium species implicated in human disease. Simultaneous detection of certain antibiotic resistance genotypes, i.e., erm(41) and rrl in M. abscessus, is also feasible. This platform detected both reference strains and clinical isolates with a high degree of specificity and sensitivity.

In this study, the investigators plan to verify the detection efficiency of GenSeizer in clinical samples (sputum, alveolar lavage fluid) and compare it with existing methods on the market (PCR reverse hybridization) and gold standard method (target sequencing after incubation)

Eligibility Criteria:
Inclusion Criteria:

* Suspected cases of mycobacterial lung infection

Exclusion Criteria:

* No sputum
* Refused or unable to tolerate bronchoscopy
Results of Telescoping Nail In OI; a Case Series

Assess the postoperative functional outcomes after surgical correction of skeletal deformities of lower limbs in osteogenesis imperfecta patients as regard ambulation status, postoperative complications and reoperation rate.

Osteogenesis imperfecta (OI) is a rare heterogeneous group of inherited disorders characterized by brittle bones, frequent fractures, and skeletal deformities that affect an individual's ability to walk. Based on Sillence classification, there are four types of OI; Type I (mild, non-deforming), Type II (perinatal lethal), Type III (severely deforming), and Type IV (moderately deforming). Recently 3 types added type V, VI and type VII.

Deformities of the long bones are common in patients with osteogenesis imperfecta particularly in the lower limbs Where they are also more severe. Multiple fractures can occur and the ability to walk may be compromised.

The goal of orthopaedic surgery implies the correction of long bone bowing, rotational malalignment, angular deformity and prevention or reduction of the fracture incidence .Surgical intervention in the form of multiple osteotomies, realignment and fixation by intramedullary rods can correct deformity of the long bones and provides internal support enhancing the potential for standing and assisted or independent walking Sofield and Millar, Page and Mead popularized the operation of multiple osteotomies and fixation by intramedullary rods. In 1963 the baily dubow nail was first introduced The telescopic rodding and nailing have been developed in order to obtain a long lasting osteosynthesis in a growing long bone, thus, reducing the need of replacement. The evolution of telescoping rods for the treatment of fractures and deformity in children with diminished bone Quality has resulted in an approved and commercially available new single entry telescopic rod system, the Fassier Duval Telescopic IM System (FD-rod).

In recent publications a high reoperation rate for proximal rod migration and a complication rate up to 40% because of rod migration, limited telescoping and joint protrusion was found.

We hope that our study will advance the proper surgical intervention for children with osteogenesis imperfecta for better functional outcomes

Eligibility Criteria:
Inclusion Criteria:

* Age from 3-11 years
* Severe lower limb deformity presented with or without fracture

Exclusion Criteria:

* Nondisplaced/incomplete fractures in minimally deformed bones
* Deformity angulation less than 20 degree
Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction

Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors are essential for platelet activation. Antagonists against the P2Y12 receptor, which are established in secondary prevention of myocardial infarction, have unexplained anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced infection-related mortality compared to clopidogrel, previous standard treatment for patients with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant platelet extracellular vesicles. The investigators assume that decrease in infection-related mortality in patients treated with ticagrelor may be explained by greater inhibition of the release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected to identify an additional mechanism of action of ticagrelor, which might contribute to the observed clinical benefits in patients treated with ticagrelor.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Informed consent to participate in the study
* Percutaneous coronary intervention with stent implantation due to first S T elevation myocardial infarction, or first non S T -elevation myocardial infarction
* Administration of a loading dose of clopidogrel

Exclusion Criteria:

* Known coagulopathy
* Known history of bleeding disorder
* Suspicion of intracranial haemorrhage
* Need for oral anticoagulation therapy
* Administration of glycoprotein (GP) II b - III a antagonists
* Cardiogenic shock
* Severe chronic renal failure (estimated glomerular filtration rate \< 30 mL/min)
* Severe liver insufficiency
* Chronic dyspnea
* Increased risk of bradycardia
* Autoimmune disease
* Infectious disease
* Neoplasms
* Pregnancy
* Study drug intolerance
* Co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors
* Participation in any previous study with ticagrelor or clopidogrel
Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.

Penile engorgement during intraoperative period is of rare occurrence however when do happens, leads to difficulty in performing and even cancellation of elective urogenital surgery. The mechanism behind intraoperative penile engorgement is complex and involves various factors. One common myth is that penile engorgement occurs only during spinal anaesthesia and not in general anaesthesia. In this study we intend to report the incidence and management of intraoperative penile engorgement in pediatric patients undergoing urogenital operations under spinal anesthesia with/without sedation over a period of one year. The pathophysiology and role of common contributing factors leading to intraoperative penile engorgement are also discussed.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist grade1 \& 2
* Elective urogenital surgery of expected duration less than one hour

Exclusion Criteria:

* patients with local infection, coagulation abnormalities, expected duration of surgery \>1 hour and spinal anomalies.
* parents of patient not giving consent for spinal anaesthesia.
Comparison of Postoperative Outcomes of Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension With the Salman Ketenci Gencer Technique

Comparison of Early Postoperative Outcomes of Patients Undergoing Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension with the Salman Ketenci Gencer Technique


Eligibility Criteria:
Inclusion Criteria:

* Patients with stage 3 or 4 pelvic organ prolapse Sexually active patients

Exclusion Criteria:

* Cervical pathology History of loop electrosurgical excision procedure (LEEP) or conization Presence of vaginal, pelvic, or adnexal mass Suspicious abdominal malignancy Morbid obesity Any pelvic infection Signs of pregnancy