cyrilzakka/clinical-trials huggingface dataset:
Impact of Early Mobilization on SAH Patients Physiological Parameters

The aim of the study is to evaluate the physiological response to out-of-bed mobilization in patients admitted to the intensive care unit for subarachnoid hemorrhage. More specifically, the aim is to measure the impact on cerebral perfusion, lung aeration, cardiovascular and respiratory parameters.

In patients with subarachnoid hemorrhage, the mobilization strategy has been little studied. Several studies have already evaluated the consequences of mobilization in bed. Because of the deleterious consequences of prolonged bed rest, and in line with recommendations, practices have evolved towards early out-of-bed mobilization, which has shown benefits. However, the physiological consequences of out-of-bed mobilization have not yet been assessed. The aim of this study is to measure the impact of early out-of-bed mobilization of patients admitted for SAH on neuro-cardio-pulmonary physiological parameters.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years

* Aneurysmal SAH
* Severity score World Federation Neurological Surgeons I to IV
* Secured aneurysm
* Eligible for their first early mobilization

Exclusion Criteria:

* Sedated patient
* Disturbed alertness, coma
* Unsecured aneurysm
* Patients under legal protection (guardianship, curatorship, safeguard of justice)
Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone

The purpose of this study is to determine effects of combination therapy with rosuvastatin and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary lesions with intermediate stenosis in patient with coronary artery disease, compared with rosuvastatin alone therapy.

Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. In the past few decades, optimal pharmacological therapies with statins targeting LDL-cholesterol substantially reduce the risks of cardiovascular disease. However, the residual cardiovascular risk is still high, requiring need for additional preventive therapies to achieve even greater risk reduction.

Recent meta-analysis demonstrated fibrates can reduce the risk of coronary events and might have a role in patients with high cardiovascular risks or combined dyslipidemia. Likewise, fenofibrate had a possible benefit for patients with high triglyceride level and low HDL-cholesterol level in the post-hoc analysis of ACCORD or FIELD trials.

Thus, investigators tried to determine effects of combination therapy with rosuvastatin and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary lesions with intermediate stenosis in patient with coronary artery disease, compared with rosuvastatin alone therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease who were 20 years of age or older and needed coronary angiography
* Intermediate coronary artery stenosis (diameter stenosis ≥30% to ≤60% by visual estimation, diameter ≥2.0 mm to ≤4.0 mm, de novo lesion in native coronary artery) in which virtual histology-intravascular ultrasound (VH-IVUS) could be feasible
* Combined dyslipidemia

  * Stain-naive patients - LDL-cholesterol ≥70 mg/dL and non-HDL-cholesterol ≥130 mg/dL
  * Patients taking statin within 2 weeks - LDL-cholesterol \< 100 mg/dL and non-HDL-cholesterol ≥100 mg/dL
* Patients who gave written informed consent

Exclusion Criteria:

* Diabetic patients
* Cardiogenic shock
* Heart failure with symptoms of New York Heart Association class III/IV or left ventricular ejection fraction \<35%
* Renal dysfunction (creatinine level ≥1.7 mg/dL or dependence of dialysis
* Hepatic dysfunction (transaminase level \> 3 times of normal within limit)
* Pregnancy or breast-feeding women
* Familial hypercholesterolemia
* Hypertriglyceridemia (triglyceride level \>500 mg/dL)
Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients

There are three elements to this study:

* Part A: Single dose escalation in healthy subjects. 6 dose levels of QAK423 are planned in healthy volunteers.
* Part B: Single dose escalation in patients with mild/moderate COPD. 3 dose levels of QAK423 are planned in COPD patients.
* Part C: Titrated repeat dosing for a maximum of 14 days in mild/moderate COPD patients.

Repeat dosing is planned in COPD patients.


Eligibility Criteria:
Inclusion Criteria:

Part A:

* Healthy, male subjects aged 18-55 years of age able to provide written informed consent prior to study participation and determined as in good health by past medical history, physical examination, ECG, laboratory tests and urinalysis.

Parts B and C:

* Male or female (post menopausal or surgically sterilized) patients with COPD, aged 40-75 years, with a smoking history of at least 10 pack years (i.e. smokers or ex-smokers).
* Diagnosis of mild or moderate COPD, according to the GOLD guidelines.
* Post-bronchodilator FEV1 at screening 50-80% of predicted.
* No COPD exacerbations within the 3 months prior to dosing, no concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
* No medical conditions that may jeopardize the subjects participation in the study
* Weigh less than 100 kg

Exclusion Criteria:

* Use of any prescription drug or over-the-counter (OTC) medication within 2 weeks prior to dosing.
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* History of clinically significant drug allergy. A known hypersensitivity to the study drug or drugs similar to the study drug.

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Myofascial Release With Tennis Ball on Spasticity and Motor Functions

Impaired motor function and upper extremity spasticity are common concerns in patients after stroke. It is essential to plan therapeutic techniques to recover from the stroke. The objective of this study was to investigate the effects of myofascial release with the tennis ball on spasticity and motor functions of the upper extremity in patients with chronic stroke.

Myofascial release is a therapeutic technique that aims to improve flexibility and sliding between layers of soft tissues, reduce the severity of muscle activity pain, and improve functional performance. A previous study included myofascial release with a tennis ball in the lower extremity in patients with chronic stroke and reported improved balance. Different other unique therapeutic interventions have been proposed over the past two decades for stroke management; however, myofascial release with a tennis ball has not been included in them. Therefore, the present study aimed to examine the effects of myofascial release with a tennis ball on spasticity and motor functions of the upper limb in patients with chronic stroke.

Participants were equally divided into two groups viz. experimental and control, with 11 participants in each group.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral stroke,
* Hemiplegia with upper extremity dysfunctions of more than 6 months and less than 2 years of duration
* modified Ashworth scale of grade 1-3,
* Mini-Mental State Exam (MMSE) \>24 suggesting intact cognition,
* full passive range of motion of the shoulder, elbow, wrist, and hand joints
* voluntary control by Brunnstrom of grade 3-5 for shoulder, elbow, and wrist joints

Exclusion Criteria:

* circulatory problems such as deep vein thrombosis,
* impaired sensation over the affected upper limb,
* recently injured area/open wounds,
* arthritic or any other musculoskeletal condition of the upper extremity, shoulder instability based on the posterior or anterior apprehension test, and positive sulcus test,
* history of brain surgery after stroke,
* Botox injection in the past four months,
* medically unstable patients,
* patients who have had multiple strokes.
LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein

The aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life, postoperative recovery and return to daily activities, complications and recurrences


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age \> 18 years
* inguinal hernia(primary, recurrence or bilateral)
* elective procedure

Exclusion Criteria:

* Scrotal hernia
* Prostatectomy, Pfannenstiehl-incision, pre-peritoneal surgery in history
* Participation in other trial
* Pregnancy
* Communicative or cognitive restrictions
Ultrasonography and Electrophysiology in GBS

Description of the time course of nerve ultrasonography changes in correlation to nerve conduction studies (NCS) and clinical course.

GBS is an acute- or subacute-onset polyradiculoneuropathy that often follows an upper or lower respiratory illness or gastroenteritis by 10 to 14 days. Approximately 70% of patients can identify a preceding illness, although it is often benign and may be minimized or forgotten by the patient.

GBS evolves over days, often beginning with numbness in the lower limbs and weakness in the same distribution. The progression of symptoms, particularly weakness, can be rapid, resulting in quadriplegia within a few days. About 50% of patients develop some degree of facial weakness. Weakness attributed to other cranial nerves includes ocular dysmotility, pupillary changes, and ptosis. Thirty percent of patients with GBS develop respiratory failure from phrenic nerve disease, requiring intubation and ventilation. Autonomic involvement is common in GBS, with the most common manifestations being tachycardia, bradycardia, hypertension and hypotension, gastric hypomotility, and urinary retention.

Evidence-based research supports the use of immunotherapy for GBS; proven therapies are IV immunoglobulin (IVIg) and plasma exchange, which have been shown to be equally efficacious in the management of GBS.

At present, no biomarkers exist in the blood, urine, or CSF that confirm the diagnosis of GBS. Most patients with GBS will have an elevated CSF protein, but this laboratory finding may not be present until 3 weeks after the onset of the illness. Nerve conduction studies (NCS) play an important role in support GBS diagnosis and subtype classification. In the first few days of the illness, nerve conduction studies may be normal or only show subtle changes of demyelination, such as prolonged or absent F waves and H reflexes, and patchy changes in distal latencies in patients with AIDP.

More recently, there has been a rise in the use of peripheral nerve ultrasound (US) in the investigation of peripheral neuropathies. Whilst nerve conduction studies (NCS) are helpful at providing information on the function of nerves, US is able to provide information on nerve morphology. The value of nerve ultrasonography (NUS) in immune-mediated polyneuropathies is well described in the previous studies. In post-GBS patients patchy and slight enlargements have been reported. Whereas in acute stage cervical spinal nerve enlargement and hypertrophy of the vagus are probably the most obvious findings. However, only little is known about the course of nerve morphology from onset until clinical recovery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients newly diagnosed as Guillain Barre Syndrome using diagnostic criteria for GBS.
2. Patients from both sex and at any age group with recent onset of GBS.

Exclusion Criteria:

* Patients with other possible causes of peripheral neuropathy, diabetes, renal, metabolic and others
Artificially Intelligent Model for Accurate Detection of HCC

Purpose: Integrating comprehensive information on hepatocellular carcinoma (HCC) is essential to improve its early detection. The investigators aimed to develop a model with multi-modal features (MMF) using artificial intelligence (AI) approaches to enhance the performance of HCC detection.

Experimental Design: A total of 1,092 participants were enrolled from 16 centers. These participants were allocated into the training, internal validation, and external validation cohorts. Peripheral blood specimens were collected prospectively and subjected to mass cytometry analysis. Clinical and radiological data were obtained from electrical medical records. Various AI methods were employed to identify pertinent features and construct single-modal models with optimal performance. The XGBoost algorithm was utilized to amalgamate these models, integrating multi-modal information and facilitating the development of a fusion model. Model evaluation and interpretability were demonstrated using the SHapley Additive exPlanations method.


Eligibility Criteria:
Inclusion Criteria:

* Benign liver diseases, including but not limited to, hemangiomas, hepatic cysts, focal nodular hyperplasia, and cirrhosis

Exclusion Criteria:

* Participants who had undergone previous treatment for HCC or benign liver diseases,
* had taken medications affecting the hematological system within 2 weeks
* those who had received a blood transfusion within 6 months
Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model

Rheumatoid Arthritis (RA) is an inflammatory rheumatic disease that can lead to structural damage and handicap. The RA physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the RA mechanism, and improves the diagnosis and the treatment of the disease.

The physiopathology of RA is multifactorial, implicating genetic and environmental factors. Within the environmental factors, the exact role of psychological stress and life events on the onset of the disease is still under question. In clinical practice, patients usually report the occurrence of a stressing life event before the diagnosis of the disease (mourning, dismissal, divorce...). Nevertheless, literature reviews present some discrepancies and did not lead to a clear identification of the role of psychological stress in RA onset. This is mainly due to the evaluation methods of stress within those previous studies, considering stress as a unique response of the organism without taking into account personal, sociological, biological or environmental history. The aim of the study is to analyze the impact of stress on the RA onset within an integrative model, to evaluate patient assessment of the stress, and to present strategies to fix it.

Eligibility Criteria:
Patients RA :

Inclusion Criteria:

* patients aged over 18 years old
* patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years.
* Speaking and understanding French language
* Being informed about the study and having given his oral consent

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient who refuse to participate.

Control :

Inclusion Criteria:

* patients aged over 18 years old
* patients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration...)
* Speaking and understanding French language
* Being informed about the study and having given his oral consent

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient who refuse to participate
Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture

Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.

Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.

Eligibility Criteria:
Inclusion Criteria:

* Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.
* Fractures amenable to treatment using intra oral approach.

Exclusion Criteria:

* Medically compromised patients who are unfit for the procedure under general anesthesia.
* Patients with comminuted fractures.
* Patients with history of occlusion disturbances or skeletal malocclusion.
* Patients with insufficient dentition to reproduce occlusion.
Endoscopic Ultrasound (EUS) Processor Comparison

The primary objective for this study is to compare the image quality of two endoscopic ultrasound (EUS) processors used for imaging of the pancreas. Processor images are used to make a correct clinical diagnosis and higher quality imaging is related to more accurate results. Patient care may be improved due to the information collected as part of this study.

The quality of imaging is of utmost importance for diagnosing early neoplasms in the pancreas and diseases such as chronic pancreatitis. Image quality is dictated by two factors: image resolution and depth of penetration. Good imaging enables diagnosis of early stage disease and thereby facilitates early treatment.

The endoscope is usually connected to a processor that generates an image which is viewed on a monitor. At FH, we use a processor called Aloka 10. A new processor is being developed by Olympus Corporation called EU-ME 2. This new processor is FDA approved, but has not been launched commercially yet. It has been loaned to FH for evaluation. We would like to evaluate this processor in an objective manner and hence the request for study approval.

In this study, the endoscopy during the procedure will be attached to two different processors and images will be generated. The choice of which processor will be used first will be at the discretion of the Endoscopist. This does not require removal and reintroduction of the endoscope into the patient at two occasions. Only the connector will be switched to a different processor. So there is negligible risk to the patient.

The time required for research activities will be between 5-10 minutes. Both processors will be set up in the procedure room for the duration of this study.

The physician will then document the depth of penetration of the image (the farthest structure seen) and image resolution (evaluating the pancreas for subtle abnormalities). Both processors will be used for each patient. The scores for each processor will be documented to a procedure log, using the primary endpoint described above. The CRF will not have any patient information. Images viewed by the physician at the time of procedure will not be saved or recorded as part of this study..

EUS will be performed in the standard fashion by one of the experienced endosonographers in the unit. Once the EUS is complete, the procedure will be stopped and the echoendoscope withdrawn from the patient.

Patients will then be transported to the recovery area for observation as per standard policy. After appropriate observations are deemed satisfactory, patients will be discharged as per unit policy.

Eligibility Criteria:
Inclusion Criteria:

All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreas will be included.

Exclusion Criteria:

Age \<19 years Unable to safely undergo EUS for any reason
Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion

Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 60 years
* Hip fracture requiring surgical intervention
* Signs consent and agrees to participate

Exclusion Criteria:

* Under the age of 60
* Does not sign consent or refuses participation
* Known hypersensitivity to tranexamic acid
* Multiple acute fractures
* Creatinine clearance \<30
* History of seizures
* Active hormone therapy
* History of coagulation abnormality
* History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE
* Myocardial infarction (MI) and/or stents within the past year
* History of intracranial hemorrhage
* Acquired defective color vision
* Patients admitted directly to nursing units or surgery without stay in the Emergency Center
* Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital
Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries

Around 10% of patients with myocardial infarction (MI) present with nonobstructive coronary arteries (MINOCA) which pathophysiology is often uncertain. The aim of the study is to evaluate inflammation and endothelial dysfunction biomarkers in MINOCA patients during both acute and stable phases, comparing them with those with MI and obstructive coronary arteries (MICAD).

Prospective observational study in patients with Myocardial Infarction (MI) divided into two groups: MI with obstructive coronary arteries (MICAD) and MI with non-obstructive coronary arteries (MINOCA). Levels of interleukin-6, tumor necrosis factor-alpha, high-sensitivity C- reactive protein, and asymmetric dimethylarginine will be determined at three time points: within the 24 hours from the onset of pain, discharge, and two months after MI. The association of biomarkers, normalized by peak troponin value, with the risk of MINOCA will be evaluated using logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with Myocardial Infarction and undergo a coronariography
* Patients must sign informed consent.

Exclusion Criteria:

* Patients who don´t sign informed consent
Supraclavicular Fossa US View for Catheter Positioning in Right Subclavian Central Venous Catheterization

The study will evaluate if the supraclavicular fossa ultrasound view can be used to achieve a correct catheter tip placement in infraclavicular right subclavian central venous catheter placement. This may make routine post-procedural x-ray exams redundant.

Central venous catheterization is one of the most common procedures within intensive care medicine. Verification of correct catheter tip placement is a primary aspect of safety and quality of central venous catheterization as malposition may lead to life-threatening complications such as thrombosis, hemothorax, cardiac tamponade, and arrhythmias. Conventional chest x-ray (CXR) is routinely performed after every insertion and is considered gold standard to examine catheter tip location and evaluate for complications such as pneumo- and hemothorax. However, CXR exposes the patient to ionized radiation, requires a considerable amount of time, and is workload-generating for both ICU and radiology staff.

Weber et al has described the use of the right supraclavicular fossa view for real-time ultrasound-guided placement of a central venous catheter (CVC) via the right internal jugular vein (IJV) in adults. This approach has subsequently been validated in a clinical study and has also been used for supraclavicular subclavian line insertion. The approach requires use of a microconvex probe, which couples good image resolution and high scanning depth. The use of a microconvex probe for infraclavicular subclavian central venous catheter (CVC) insertion has been described previously, but this is the first description of the supraclavicular fossa ultrasound view to guide correct catheter tip placement in infraclavicular right subclavian CVC placement.

Eligibility Criteria:
Inclusion Criteria:

* Indication for central venous catheter placement.

Exclusion Criteria:

* Operator unable to visualize the subclavian vein (e.g., in those with subcutaneous emphysema of the chest wall),
* Subclavian vein catheterization deemed inappropriate by the operator,
* Central line/pacemaker/similar device already in place (risk for misinterpretation of the ultrasound image)