cyrilzakka/clinical-trials huggingface dataset:
The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia

The effect of two different positions on spinal anesthesia in hip fracture surgery

One of the more common reasons for hospitalization in affluent nations is femoral fractures. Postpartum mortality and morbidity rates for femur fractures are significant. Mortality rates range from 5% to 8% at the time of initial admission and from 14% to 36% throughout the first year. Age-related mortality rates are rising. Surgery is necessary for femur fractures, and spinal anesthesia is frequently the recommended anaesthetic approach.

After spinal anesthesia, hypotension is frequently seen as a result of sympathetic block and a reduction in systemic vascular resistance. The frequency of hypotension rises as the level of spinal anesthetic block increases, especially in older people. It has been demonstrated that hypotension is connected with an increased mortality rate.

Preoperative fluid administration to reduce hypotension loading, lateral decubitus anesthesia posture, and spinal anesthetic dose reduction techniques have all been used.

There are several methods to enhance the quality of the block in spinal anesthesia, including local changes to the anesthetic's baricity, volume, infusion rate, and lateral decubitus position. There are numerous variables, including residency time and spinal needle type. The influence of alterations in the spinal cord inside the vertebral column on body position in the literature was examined using lumbar MR imaging. Based on these research, it was intended to study the role that alterations in spinal anesthesia played in the applications of spinal anesthesia. spinal column Hemiblock is thought to result in more stable hemodynamics during anesthesia. Studies can be found. The goal of this study is to administer semispinal anesthesia while doing spinal anesthesia. To ensure that the underlying spinal cord is impacted by the local anesthetic and to monitor the impact on unilateral block development and hemodynamic parameters, the colon is flexed and squeezed to the surgery side and anterior area of the spinal cord.

The study will take unilateral femoral fracture surgery into account. Both groups will be given spinal anesthesia in the study's lateral

First, Group F will keep the spinal cord flexed for 10 minutes while Group N will preserve the spinal cord's normal position in lateral decubitus. The quality of the ensuing block will be compared between the two groups. When spinal anesthetic is being used, patients may feel excruciating pain while in the prescribed position.

To lessen positional pain and the impact of hemodynamic deterioration brought on by pain during spinal anesthesia, pericapsular nerve group (PENG) block will be used.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2-3
* Hip fracture
* 18-85 Age
* BMI: 18-40

Exclusion Criteria:

* ASA score of 4 and above
* Left ventricular ejection fraction below 40%
* Severe aortic valve stenosis
* Obesity (BMI \>40)
* Presence of cardiac arrhythmia
* Having peripheral vascular disease
* Failure of spinal block
* Bleeding diathesis
Added Value of Contrast Enhanced Spectral Mammography, CESM. A Pilot Study.

Introduction: To avoid unnecessary mastectomies and reoperations a correct size assessment of malignant lesions in breast is required. Sometimes a supplementary MRI is therefore recommended. However, at our unit MRI is not easily available. Contrast enhanced spectral mammography (CESM) has in smaller studies been shown to be equal to MRI regarding sensitivity and specificity. Size assessment using contrast-based modalities as CESM has also been shown to be significantly more accurate than using mammography. Prospective randomized studies using CESM are lacking.

Aim: The aim of the study is to evaluate the added value of CESM in diagnostics of breast cancer and choice of operation; partial mastectomy or mastectomy.

A pilot study of 50 patients will be conducted to prepare for a larger prospective randomized study.

Method: Patients found with breast cancer after diagnostics with mammography, ultrasound and core biopsy, and whom are recommended primary surgery, will be enrolled in the study. A supplementary examination with CESM will be performed. Preoperative extent of the malignant lesions are estimated with each modality and is later compared with the extent measured in post-operative PAD. Data on weight, length, age at menopaus, use of contraceptive pills, HRT or endocrine therapy, breast volume and density is collected, as well as data of diagnosis (ductal or lobular carcinoma), surrounding DCIS, histological grade, ER, PgR, Her2 expression and Ki67 index.

In this pilot study sensitivity and specificity for each modality is calculated. Multivariate analysis will be performed regarding influential factors. Pearson correlation coefficient will be calculated for each modality regarding size assessment of the malignant lesions in comparison with definitive PAD.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with breast cancer and whom are planned for primary surgery
* Signed informed consent

Exclusion Criteria:

* Ongoing pregnancy
* Ongoing lactation
* Allergy against iodine contrast
* Treatment with metformin (against diabetes)
* Renal failure
* Hyperthyroidism
* Severe heart condition
* Myasthenia gravis
* Implants
* Inability to understand study information
Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery

Objectives:

The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the surgical removal of an impacted mandibular third molar.

Materials and Methods:

The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets.


Eligibility Criteria:
Inclusion Criteria:

* absence of systemic pathologies (ASA class I);
* non-smoker;
* not pregnant or lactating;
* good oral hygiene;
* no drug consumption for 10 days before the operation;
* bilateral impacted mandibular third molars with comparable position, depth and inclination;
* presence of the first and second molars;
* absence of painful symptoms and associated inflammatory or osteolytic pathologies in a radiographic examination;
* extraction difficulty index of \>7 according to Pederson's scale and a degree of IV (complex procedures) on a modified version of Parant's scale.

Exclusion Criteria:

-
CTC Detection Rate in SCCHN With a in Vivo Device

Detection rate and isolation yield of CTC is low in squamous cell carcinoma of head and neck (SCCHN) with in vitro approaches rely on limited sample volumes. In this study, we applied a new method, the CellCollector, which could capture CTC in vivo from peripheral blood.


Eligibility Criteria:
Inclusion Criteria:

* SCCHN confirmed with clinical examination
* Have agreed to undergo CTC analysis in vivo;
* ECOG：0-2

Exclusion Criteria:

* the other cancer types
A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer

This study is a multicentre, open label, non-randomized phase I study. The main objectives of the study are to determine the pharmacokinetic profile of the drug at different dose levels in the patients with Advanced Breast Cancer. Maximum Tolerated Dose (MTD) and safety of Paclitaxel Nanoparticle will also be simultaneously assessed.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent\* to previous anthracycline treatment as adjuvant or first line therapy for metastasis.
* Patients with ER/PR -ve or ER/PR receptor status unknown (defined as no histopathological evidence for confirmation of ER/PR status)
* Patients must be of 18-65 years of age (inclusive of both)
* Patients with ECOG performance status between 0 - 2
* Patients with at least one measurable lesion as per RECIST

Exclusion Criteria:

* Patients with ER/PR positive status. Patients who demonstrate HER2 over expression will be excluded. Alternatively, the patients enrolled should have previously received trastuzumab. HER2 over expression should be demonstrated by IHC 3+, IHC 2+ or with FISH/CIS.
* Patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients.
* Patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease. (Patients requiring local radiotherapy for non- target bone lesion will be included).
* Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).
Impact of a Training-action About Projects Leading for the Improvement of Care Quality in Managing Practice of Health Executive

The present study focuses on the quality of care and how the health executives can bring it to a central place in their management. A training-action has been set-up at the Health Executive training institute (University Hospital Grenoble) to improve care quality. Reports prepared by students (tutored projects) related to operational diagnosis and action plans about care quality improvement are given to health executives. The objective is to evaluate how the health executive will use the tutored project to improve care quality and set-up actions.The hypothesis is that the health executive will use the tutored project to improve project management.

Every year, 9 voluntary health executives will be included and followed during 1 year. The experience will be done 3 times (3 years).

It is a qualitative study using 3 forms to recover data: group focus, individual interviews, project monographs. Speeches coding will enable to test the hypothesis from 2 analysis points: place of health executive and place of tutored project.

The study will be resulting in recommendations to health executives for their management methods and taken into account to define training.

Eligibility Criteria:
Inclusion Criteria:

* The volunteers are health executives with diploma

Exclusion Criteria:
Objective Assessment of Sensory Nerve Fiber Sensitivity

This pilot study utilizes a unique technology to determine nerve fiber sensitivity. This will allow us to determine whether this method and device can discern changes in pain intensity and type, which is predicated on differing nerve fiber sensitivities.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is 18 to 65 years of age
2. The subject is willing to have a tourniquet applied as part of the study
3. The subject is willing and able to provide written informed consent to the study participation
4. The subject is willing and able to comply with all study procedures

Exclusion Criteria:

1. Eye pathology precluding pupillometry
2. Subjects who have ongoing pain requiring medical attention
3. Subjects who are not normotensive
4. Subjects with peripheral vascular disease
5. Subjects who are morbidly obese (BMI \>40)
6. Subjects with diabetes or diabetic retinopathy
7. Subjects who are or may be pregnant
8. Subjects with cardiac disease
9. Subjects with neuropathic disease states
Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children

This randomized trial aims to evaluate the health-promoting effects of intermittent dietary restrictions, including intermittent low-carbohydrate diet (ILCD) and calorie restriction (ICR), in school-aged children with cardiometabolic risk (CMR) compared with general health education based on dietary and physical activity guidelines for Chinese children.

Childhood obesity comorbid with one or more CMR factors, including hyperglycemia, dyslipidemia, and hypertension, predicts an increased risk for developing cardiovascular disease in adulthood. Lifestyle interventions, including restricting dietary calorie intake and increasing physical activity, have been proposed as the first-line behavioral weight management approaches for pediatric obesity. Long-term adherence to daily dietary restriction is challenging for young populations because they are in a particular period of physical and psychological growth and lifestyle formation. Low-carbohydrate diet and ICR have shown effectiveness in improving cardiometabolic health in adults, however, the evidence supporting the effects of these diets in pediatric populations remains limited.

Eligible participants will be randomized to receive intermittent dietary restriction, including an ILCD (carbohydrate intake ≤ 50 g/d for two days per week) or an ICR (calorie intake is 500-600 kcal/d for two days per week), or general health education based on dietary and physical activity guidelines for Chinese children in daily life. The total study duration will be 12 months consisting of a 3-month intervention phase and a 9-month self-maintenance phase.

Eligibility Criteria:
Inclusion Criteria:

* Aged 7-18 years at baseline.
* At least one of the following cardio-metabolic abnormalities:

  1. Prediabetes (Impaired fasting glucose: 5.6 ≤ fasting blood glucose level ≤ 6.9 mmol/L; or Impaired glucose tolerance: 7.8 ≤ blood glucose level after 2 hours postprandial ≤ 11.0 mmol/L).
  2. Lipid abnormalities (High-density lipoprotein cholesterol ≤ 1.04 mmol/L; or Low-density lipoprotein cholesterol ≥ 3.37 mmol/L; or Triglycerides ≥ 1.70 mmol/L, or Total cholesterol ≥ 5.18 mmol/L).
  3. Elevated blood pressure (Systolic/diastolic blood pressure consistently higher than the 90th percentile for gender, age, and height; or systolic/diastolic blood pressure ≥ 120/80 mmHg).

Exclusion Criteria:

* Previously diagnosed with heart failure, severe malnutrition, immune deficiency, liver or kidney disease, cancer, or other diseases deemed unsuitable for participation.
* Had a history of bariatric surgery.
* Used weight loss pills or supplements in the last three months.
* Other situations unsuitable for participation.
Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

In patients with severe obesity, bariatric surgery provides consistent and long-term weight loss. BMI ≥50kg / m2 is an independent factor of increased morbidity / mortality in bariatric surgery compared with patients weighing less than 50 kg / m2 (1.2% and 0.8%) mainly due to technical difficulties. Preoperative weight loss reduces this morbidity / mortality. Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss. The purpose of this study was to evaluate the safety and effectiveness of the association bariatric embolization before sleeve gastrectomy in super obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Willing, able and mentally competent to provide written informed consent.
* Body mass index (BMI) \>50kg/m².
* 3 risk factors (De Maria et al) among: hypertension, male gender, age\>45, risk of pulmonary embolism
* Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to Bariatric Embolization, as assessed on 3D CT angiography.
* Adequate hematological, hepatic and renal function as follows:

Hematological Neutrophils \> 1.5 x 109/L Platelets \> 100 x 109/L INR \<1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated GFR \> 60ml/min.1.73m2

* Aged 18 years or older.
* Patient who is going to be operated by sleeve gastrectomy

Exclusion Criteria:

* Prior history of gastric pancreatic, hepatic, and/or splenic surgery
* Prior radiation to the upper abdomen
* Prior embolization to the stomach, spleen or liver
* Portal venous hypertension
* Prior or current history of peptic ulcer disease
* Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
* Active H. Pylori infection
* Weight greater than 240 kg
* Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of \< 60 milliliters per minute
* Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease.

Pregnancy

* ASA Class 4 or 5 (very high risk surgical candidates: class 4= incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study will be excluded from participation. This exclusion criterion exists because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects.
* History of Inflammatory Bowel Disease
* Cirrhosis
* Known history of allergy to iodinated contrast media
* Contraindications to use Embosphere (ex:known allergy to gelatin ..)
Effect of Plugging the Registration Pin Tract in Robotic-assisted Knee Surgery

Introduction: Complications of robotic-assisted total knee arthroplasty (TKA) seem to be rare and consist mainly of infections or fractures. In the Reinier Haga Orthopedisch Centrum (RHOC), postoperative bleeding is experienced to be a complication that often occurs, mainly at the tibial wounds of the registration pins used in robotic-assisted TKA. This often results in longer hospital stay and might interfere with the current fast track knee surgery by a delayed discharge. To overcome this complication, nowadays bone plugs are used in the two drill-holes. Currently, it is unknown whether these bone plugs reduces the incidence of postoperative bleeding.

Objective: To evaluate the incidence of postoperative bleeding in patients that underwent a robotic-assisted TKA and received bone plugs in the two drill-holes in the tibia, compared to patients that underwent the same operation but did not receive bone plugs.

Study design: Retrospective, inventory study

Study population: All patients that underwent a robotic-assisted TKA in the RHOC from December 2020 till October 2022.

Intervention: In the past, some patients that underwent a robotic-assisted TKA received a bone plug in the two tibial drill-holes. This bone is collected from the excess bone that is removed during the operation.

Main study parameters/endpoints: Incidence of postoperative bleeding in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Underwent robotic-assisted total knee arthroplasty between December 2020 and October 2022 with or without the use of bone plugs
* Does not object against use of medical data
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis(OA)

This 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study.


Eligibility Criteria:
Inclusion Criteria:

* Have completed the core CCOX189A2360 study
* Males and females over the 18 years old

Exclusion Criteria:

* Treatment in the extension study is not considered appropriate by the treating physician
* Non-compliance or major protocol violation of the core study

Other protocol-defined inclusion/exclusion criteria may apply
Otitis Media With Effusion and Type 2 Inflammation Diseases

Otitis media with effusion (OME) is thought to be associated with comorbidities such as allergic rhinitis, gastroesophageal reflux disease, asthma, and more. Many of these comorbidities can be caused by type 2 inflammation (T2I). This study aims to characterize the risk of undergoing OME surgery. This retrospective, matched-cohort study involved the retrospective recruitment of patients from 2009 to 2020, using the Taiwan National Health Insurance Research Database (NHIRD)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OME
* At least two outpatient visits or one hospitalization record
* Medical records within the database

Exclusion Criteria:

* Participants younger than 4 years old
* Participants with unclear demographic information
* Participants with a history of ear surgery or congenital ear anomalies
* Participants who had undergone OME surgery before the index date
Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease

The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is:

Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled.

Participants will undergo a modification of the traditional STN DBS approach for motor symptoms of PD. In addition to the two leads placed within the STN, two additional leads will be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel stimulation patterns will be used within the NBM to target cognitive and cognitive-motor symptoms using an investigational software. Participants will be followed over two years while receiving this therapy with assessments at baseline and every six months. Assessments will include a combination of neuropsychological evaluations, cognitive assessments, motor tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different surgical trajectories will be used, with half the cohort randomized to each group. This will allow comparison of the impact of surgical trajectory on the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease (PD)
* Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS)
* Willingness to withdraw from clinical medication regimen when necessary for research visits
* Ability to provide informed consent

Exclusion Criteria:

* Dementia
* Unstable medical, psychiatric conditions including significant untreated depression, history of suicidal attempt, or current suicide ideation
* History of seizures
* Pregnant
* Requires MRI
* Unable to walk 100 feet without an assistive device