cyrilzakka/clinical-trials huggingface dataset:
Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty (Electrocoagulation vs Scalpel)

Comparison of clinical outcomes of electrocoagulation and non-electrocoagulation techniques in total hip and knee arthroplasty surgery

Objectives:

A. To evaluate the effectiveness of electrocoagulation:

* To measure the reduction in intraoperative bleeding volume when using electrocoagulation.
* Analyse the impact of electrocoagulation on surgical visibility and accuracy during implant placement.

B. Comparison of surgical outcomes:

* Investigate the incidence of intra- and postoperative complications, such as incidental vascular-nerve injury, wound infections, deep vein thrombosis, and implant-related problems, in patients operated on with electrocoagulation versus techniques without electrocoagulation.
* Examine the influence of haemostatic technique on the need for blood transfusion during or after surgery.
* Evaluation of long-term functional outcomes and patient satisfaction, including joint stability and range of motion, in both groups.

C. Review of patient recovery and period of hospitalization:

* Analysis of the impact of electrocoagulation on length of hospitalisation, and time to ambulation.
* Assessment of postoperative pain levels and analgesic medication use between the two groups.
* Patients' return to daily activities and overall quality of life after surgery.

D. Comparison of data obtained with other studies conducted internationally.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have given informed consent to the procedure
* Patients admitted over 18 years of age
* Patients with pathology requiring primary joint replacement (symptomatic gonarthrosis/coxarthrosis, Avascular necrosis (AVN) of the femoral head , femoral neck fractures, etc)

Exclusion Criteria:

* Contraindications for major surgery or anaesthesia
* Patients with active infections that could interfere with outcome assessment
* Patients unable to give informed consent for psychological or cognitive reasons
* Severe medical conditions such as coagulopathies that may significantly influence outcomes
* Patients unable or unwilling to adhere to the required follow-up period
* Patients who died during the study period
* Patients with revision prosthesis operations
Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy

This study will examine the effect of providing a structured program of daily nutritional supplements for a 8 weeks of intervention prior to Sleeve Gastrectomy bariatric surgery on bone mass density status and formation of critical nutritional deficiencies years after the surgery.

The present study hypothesis holds that providing an adequate nutritional supplements program prior to the surgery, combined with postoperative monitoring, will significantly lower the incidence of nutritional deficiencies in patients undergoing Sleeve Gastrectomy surgery, and will reduce complications arising from these pre-operative deficiencies.

The investigators plan to examine the effect of Vitamins supplementation prior to surgery on the status of postoperative deficiencies one year after the surgery. Evaluation of outcomes will be made based on the results of blood tests specified, and related tests of bone density.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for bariatric surgery
* BMI over 35 kg / m 2 accompanying morbidity or BMI over 40 kg / m 2,
* pre-operative evaluation standards with matching to carry sleeve gastrectomy surgery
* Vitamin D deficiency prior to surgery

Exclusion Criteria:

* patients who underwent bariatric surgery in the past
* psychiatric or mentally contraindication for the procedure
* lack of consent to follow-up
* endocrine problem that affects the weight that is unbalanced.
* Chronic kidney disease (CKD), nephrolithiasis
* Hypercalcaemia
* Hypercalciuria and renal stones nephrolithiasis
* Pregnancy, breastfeeding
* Using medications or disease condition known as affecting the status of calcium or bone metabolism 3 month prior to intervention
* Taking any nutritional supplements 2 weeks before the study.
Use of Corticosteroids in Third Molar Surgery

Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain, that lead to a decrease in patients' quality of life. Therefore, the use of drugs is essential to reduce the morbidity associated with surgery, with NSAIDs and corticosteroids being the most commonly used drugs.

Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain. Traditionally, NSAIDs have been used for the treatment of postoperative pain and inflammation, although corticosteroids are increasingly used in oral surgery, as they have proven to be clinically effective in reducing postoperative complications without causing serious adverse effects. Although numerous studies have been carried out comparing different corticosteroids in order to determine which of them is the most effective, there is still no clinical protocol regulating the use of these drugs in oral surgery. Therefore, this clinical trial is based on comparing two of the most studied corticosteroids used in oral surgery to date: dexamethasone and methylprednisolone.

This study is based on the preoperative administration of 8mg of dexamethasone or 40mg of methylprednisolone via submucosa, randomly, in patients undergoing surgical extraction of a retained lower third molar, to determine which of these two drugs is more effective in the prevention of inflammation, trismus and postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Indication for surgical extraction of a retained lower third molar

Exclusion Criteria:

* Patients treated with corticosteroids in the last 3 months
* Patients treated with NSAIDs in the last 7 days
* Patients with hypersensitivity to the drug
* Patients with a medical condition that contraindicates the administration of the drug
Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections?

This study was aimed to investigate the impact of using different epidural volumes.

Patients with acute discogenic pain were included in the study.

Objectives: This study was aimed to investigate the impact of using different epidural volumes.

Methods: Seventy five patients with acute discogenic pain were included in the study.The patients were randomly assigned to three groups. All patients received a single epidural dose of triamcinolone \[80 mg\] and 12.5 mg bupivacaine combination. The patients in Group 1, Group 2 and Group 3 received a volume of 10 mL, 15 mL, and 20 mL by epidural injections, respectively. The efficacy of treatment was assessed with VAS (visual analog scale) \[O= no pain, 10 = unbearable pain\], SLET(straight leg elevation test) \[0° = worst, 85° = best\], and Oswestry Disability Index; ODI \[0% to 20%:minimal disability , 80% to 100%:bed bound patients\] before and 2 weeks after the EPSI.

Eligibility Criteria:
Inclusion Criteria:

* acute discogenic pain with less than three months duration not responding to other modalities of conservative management \[NSAIDs, physiotherapy, bracing, etc.\],
* radiological disc bulging accompanying unilateral root impingement symptoms,
* an Oswestry daily activity score more than 20 percent, and
* resistance to treatment.

Exclusion Criteria:

* Patients with bilateral root impingement symptoms, neurological deficits, and/or history of previous lumbar disc surgery, severe cardiac, pulmonary, gastrointestinal, renal diseases, glaucoma, urinary retention, and/or known allergy to the drugs used in the study were excluded from the study.
Combined Treatment With TNF Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression

It will be a pilot, 2 year, prospective, randomized, double-blind, placebo-controlled (for pamidronate) study. All patients with AS will receive treatment with TNF inhibitor, while randomization will be performed for pamidronate versus placebo group. Primary outcome will be the rate of radiographic progression of AS, calculated after 24 months of combined treatment.

It will be a pilot, 2 year, prospective, randomized, double-blind, placebo-controlled (for pamidronate) study. All patients with AS will receive treatment with tumor necrosis factor (TNF) inhibitor, as indicated by local guidelines. Randomization will be performed for pamidronate vs placebo group. Pamidronate will be prescribed as monthly intravenous infusion in the dose of 60 mg/month for the first 6 consecutive months of every study year. Primary outcome will be the rate of radiographic progression of ankylosing spondylitis (AS), calculated after 24 months of combined treatment. Clinical and laboratory disease parameters will serve as secondary outcomes. These outcomes as well as safety assessments will be performed on a monthly basis up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* presence of spinal syndesmophytes
* normal renal and liver function
* eligibility to receive anti-TNF treatment according to local guidelines

Exclusion Criteria:

* unwilling to sigh the informed consent
* presence of significant systemic or organ-limited disorders, other than AS
* any contraindication for anti-TNF or pamidronate treatment
* presence of acute dental/periodontal disease
Function and Composition of Regulatory B Cells in Participants With Glioblastoma

Rationale: This project elaborates on a novel finding of the investigators that has not yet been reported in literature, namely the presence of elevated levels of atypical B cells in participants with glioblastoma. ln the period 2015 2018 the investigators analysed the blood immune subset composition of a cohort of 180 participants undergoing neurosurgery. The most relevant finding was the presence of an abnormally elevated level of B cells in the blood of the great majority of participants with glioblastoma. These B cells may be involved in the immunosuppression associated with glioblastoma that makes this tumor refractory to immunotherapy. Multiple regression analysis indicated that the increase in the frequency of atypical B cells in participants' peripheral blood was related with the administration of dexamethasone prior to surgery. However, this study design did not allow the investigators to address the causality of the relationship between dexamethasone and atypic B cell dysregulation. Alternative treatments to dexamethasone exist.

Objective: To investigate the effect of dexamethasone in the dysregulation of atypic B cells in participants with glioblastoma.

Study design: Observational case control pilot study with 20 participants (10 per group).

Study population: Newly diagnosed participants with glioblastoma. Intervention (if applicable): Observational study. Main study parameters/endpoints: Changes in the immune subset composition and functionality in the peripheral blood of participants with glioblastoma upon administration of dexamethasone for neurological signs of peritumoral edema (oral dexamethasone).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators will collect blood (28 ml) during the first visit and again (28 ml) at the time of surgery (2 weeks ± 3 days). There will not be additional site visits, physical examinations or any other tests, questionnaires. Blood collection is only a minor discomfort and it does not represent any additional risk.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis Glioblastoma Patients are 18 years or older at first diagnosis

Exclusion Criteria:

No indication for surgery to confirm radiological diagnosis Not able or willing to give informed consent Allergy or intolerance to dexamethasone
Evaluation of Gait Impairment and Correlation With Clinical Assessment Tools Before and After Surgery in Patients With Cervical Myelopathy Using Inertial Sensors

This study aims to evaluate gait impairment in patients with Degenerative Cervical Myelopathy (DCM) before and after surgery using an inertial measurement unit (IMU) sensor. By comparing IMU-derived gait parameters with traditional clinical assessment tools (e.g., Modified Ashworth Scale, mJOA, and GRASSP), the study seeks to determine the effectiveness and reliability of IMU sensors for assessing and monitoring gait improvement and neurological recovery in DCM patients. This study is conducted outside the United States and does not involve interventions or devices subject to U.S. FDA regulation.

This observational study will investigate the correlation between gait parameters measured with an IMU sensor and established clinical evaluation tools for patients with Degenerative Cervical Myelopathy (DCM). The primary aim is to quantify gait impairments before and after surgical intervention and to verify the IMU sensor's utility as a quantitative assessment tool. The study will recruit both DCM patients and a control group to evaluate the sensitivity of the IMU sensor in detecting fine motor and gait differences. Outcomes will be analyzed using statistical comparisons of pre- and post-surgery measurements, with specific focus on gait speed, cadence, stride length, and spasticity. The anticipated goal is to validate the IMU sensor as a reliable alternative to existing clinical tools, facilitating early detection of gait impairment and monitoring post-surgical improvement in DCM patients. This study is conducted entirely outside the United States and does not involve interventions or devices subject to U.S. FDA regulation. The devices and procedures used in this study are approved by local regulatory authorities in the country where the study is conducted. The study complies with applicable international and local guidelines rather than U.S. FDA requirements.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Able to communicate and provide informed consent.
* Capable of walking at least 3 meters without assistance from others or walking aids.
* No prior surgical treatment for cervical myelopathy.
* Lower limb motor function score of 2 or higher on the mJOA scale.

Exclusion Criteria:

* Presence of severe respiratory or cardiac conditions that impede safe walking.
* Musculoskeletal issues, such as spinal deformities, affecting gait.
* History of neurological disorders affecting gait, including peripheral nerve injury, joint stiffness, stroke, traumatic brain injury, myelitis, or Parkinson's disease.
* Prior orthopedic or neurosurgical interventions that could impact gait.
* Cervical conditions resulting from trauma (acute fracture or acute disc herniation), tumor, or infection.
A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes

This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 20 years or older at the time of signing informed consent
* Glycated hemoglobin (HbA1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug (OAD) monotherapy and between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy at screening
* Japanese subjects diagnosed with type 2 diabetes who are: a) on stable OAD monotherapy at a half-maximum dose or below according to the approved Japanese labelling in addition to diet and exercise therapy for at least 30 days prior to screening (week -8) (For metformin only: the maximum dose of 750 mg/day is allowed except for METGLUCO®. For METGLUCO®, the allowable half-max dose of 1125 mg/day must be applied.). 'Stable' is defined as unchanged medication and unchanged dose, or b) on stable diet and exercise therapy for at least 30 days prior to screening (week -2)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g. abstinence, diaphragm, condom \[by the partner\], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5-week follow-up period
* Treatment with once-weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days prior to screening
* Treatment with any glucose lowering agent(s) (except for pre-trial OAD for subject treated with OAD monotherapy) in a period of 60 days prior to screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness
* Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
* History of chronic or idiopathic acute pancreatitis
* Screening calcitonin value of 50 ng/L (pg/mL) or greater
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
* Impaired renal function defined as estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
* Acute coronary or cerebrovascular event within 90 days before randomisation
* Heart failure, New York Heart Association (NYHA) class IV
Protective Effect in Cardiac Surgery Patients

The purpose of the study was to verify the protective effect of inhibiting systemic inflammatory response in patients undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* subject needs to have valve surgery
* subject needs to have coronary artery bypass grafting surgery
* subject needs to have artificial blood vessel replacement surgery
* ASA(American Society of Anesthesiologists) score II\~III
* NYHA(New York Heart Association) II\~III

Exclusion Criteria:

* LVEF(left ventricular ejection fraction) \<40% measured by echocardiogram
* history of myocardial infarction within 1 month
* history of serious pulmonary infection or endocarditis within 3 months
* history of important surgery within 6 months
Full Spectrum vs. Standard Forward-viewing Colonoscopy

The aim of this study is to evaluate FUSE-colonoscopy in terms of feasibility and its possible additive contribution in the detection of important lesions, namely polyps and cancers, compared to the standard "forward-viewing" approach, with and without the addition of the right-colon retroflexion technique, in a series of patients undergoing back-to-back screening or surveillance colonoscopies in a randomized fashion.

We changed the anticipated number of subjects enrollment for study: NCT02117674 from 120 to 200 based on the following sample size estimation:

Tandem colonoscopies studies results, show that novel endoscopic technologies detect about 20% more adenomas than those conventional colonoscopy does (missed adenomas). Since FUSE colonoscopy cannot be considered as a perfect examination, we hypothesize that conventional colonoscopy will detect one third of the missed adenomas that FUSE detects in a similar setting. Therefore a sample size of 120 adenomas achieves 80% power to detect an odds ratio of 3.0 using a two-sided McNemar test with a significance level of 0.05. The odds ratio is equivalent to a difference between two paired proportions of 14% which occurs when the proportion of detected missed adenomas during FUSE is 21% and the proportion of missed adenomas during conventional colonoscopy is 7%. During one year period before the study initiation, our colonoscopy performance quality data show that we detect a mean number of adenomas per patient equal of 0.7 in a population similar to the one recruited in our study. Therefore, 172 patients overall will be required to detect 120 adenomas. Given the uncertainty of our estimation and in order to cope with patients exclusions, withdrawals and unexpected incomplete colonoscopies, we decided to recruit 200 patients.

A more extensive description regarding the investigators study is provided in the following fields.

Eligibility Criteria:
Inclusion Criteria:

* adults undergoing elective screening or surveillance colonoscopy
* symptomatic adults with indication for colonoscopy

Exclusion Criteria:

* age over 80 years
* poor overall health (ASA III, IV)
* recent abdominal surgery
* presence of abdominal wall hernias
* active colitis
* multiple right colon diverticula
* previous bowel resection
* inflammatory bowel disease
* polyposis syndromes
Effect of Virtual Reality Immersion on Patient's Anxiety During Pre-oxygenation Before General Anaesthesia

The goal of this clinical trial is to learn if the use of virtual reality immersion during pre-oxygenation before general anesthesia could be feasible and beneficial for the patient. The main questions it aims to answer are:

Does virtual reality immersion during pre-oxygenation reduce patient's anxiety? Does it impact patient's and anaesthetist's comfort? Is this technique easy to implement?


Eligibility Criteria:
Inclusion Criteria:

* All non-ambulatory patients undergoing elective surgery or procedure under general anaesthesia with intravenous induction
* Minimal age of 18 year old
* Able to give informed consent for the study as documented by signature

Exclusion Criteria:

* Lacking capacity or ability to complete the consent form and/or questionnaire and interview method and/or incapacity to respond to the required obligations linked to the study protocol (assessed by the operator)
* Known cognitive dysfunction, previous history of neurological/psychiatric disease like epilepsy
* Depression or anxiety under treatment
* Non-Italian speaking patients
* Anticipated difficult airway management
* Injuries to the head/face that would prohibit wearing headsets
* Active nasal bleeding or occlusion, nasal abnormality or recent nasal trauma, recent nasal surgery, significant raised intracranial pressure and base of skull fractures
* Any pre-operative premedication, including pharmacological premedication
* Rapid sequence induction
* Haemodynamic instability
* Infectious skin conditions on the head/face
* Undrained pneumothorax
* Contact isolation due to bacteria and viruses
* Symptoms of vertigo or motion sickness
* Reduced visual or auditory acuity
* BMI \> 35 kg/m2
* Pregnancy
* Claustrophobia
* Pre-existing hypoxemia (baseline oxygen saturation \< 92% when breathing room air)
* Need for an arterial line before general anaesthesia induction
Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency

The investigators aim to compare the effect of ultrasound versus floroscopy guided pulsed radiofrequency treatment of the lumbar dorsal root ganglion (DRG) of S1 in patients with a chronic lumbosacral radicular pain.


Eligibility Criteria:
Inclusion Criteria:

* Persistent pain score ≥ 4 on VAS, not responding to traditional treatments
* Radicular pain in lumbar region for 3 months or more,
* Pattern of radiation suggestive for S1 pathology

Exclusion Criteria:

* Patient refusal
* Coagulopathy
* Uncooperative patients
* Malignant disorder or currently under treatment for a malignant disorder
* Pregnancy
* Leg pain due to localized hip or knee pathology