cyrilzakka/clinical-trials huggingface dataset:
Intravenous High Dose NAC and Sodium Bicarbonate for the Prevention of Contrast-induced Acute Injury

Contrast-induced acute kidney injury is a common cause of acquired in-hospital renal insufficiency and is associated with prolonged hospitalization and unfavorable early and late outcomes. The investigators sought to compare 4 different strategies (intravenous high-dose of N-acetylcysteine, sodium bicarbonate, the combination of both, and saline alone) in the prevention of contrast-induced acute kidney injury in patients undergoing coronary angiography using high-osmolar contrast media defined by creatinine and cystatin C serum levels.


Eligibility Criteria:
Inclusion Criteria:

* eligible patients include individuals aged 18 year or older with normal renal function who were schedule to undergo cardiac catheterization. During the randomized study, consecutive eligible patients schedule for exposure to the ionic, high osmolality (2130 mOsm/Kg) contrast agent Ioxitalamato.

Exclusion Criteria:

* using metformin or nonsteroidal antiinflammatory drugs within the previous 48 hours
* intake of nephrotoxic drugs during the previous seven days
* pregnancy
* lactation
* intravascular administration of an iodinated contrast medium within the previous two days
* emergency catheterization
* pulmonary edema
* acutely decompensate congestive heart failure
* history of serious reactions to iodinated contrast mediums
* renal transplantation
* end-stage renal disease necessitating dialysis
The Effect of Non-Invasive Vagal Nerve Stimulation Combined with Self-Managed Therapy in Individuals with Myogenic Temporomandibular Dysfunction

The aim of our study is to determine the benefit of non-invasive Vagal Nerve Stimulation in combination with self-administered therapy on the symptoms associated with jaw joint dysfunction in individuals with jaw joint dysfunction.

If you agree to participate in the study, you will fill out a form containing your information such as age, height, body weight. Then, Visual Analog Scale (VAS) and Central Sensitisation Scale will be used to assess the severity of jaw and neck joint pain. The 8-question Jaw Function Restriction Scale will be used to assess the limitation of jaw function.

An algometer will be used to evaluate the pressure-pain threshold, and Therabite range of motion scale will be used to evaluate the range of motion of the jaw joint. One photograph will be taken from the side profile to evaluate the head-neck posture, this photograph will be used for craniocervical angle measurement and will not be shared elsewhere. Myotonmetry will be used to evaluate muscle mechanical properties and non-invasive superficial electromyography (yEMG) will be used to evaluate muscle activation.

The treatments to be applied within the scope of the study will be carried out 3 days a week and the evaluation sessions will last 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-45,
* Diagnosed with myogenic TMDs according to TMD-DC Axis I and II criteria,
* Pain intensity of 3 or more during rest and/or chewing according to the Visual Analogue Scale,
* Volunteered to participate in the study and signed the informed consent form,
* Individuals who do not have communication difficulties and whose native language is Turkish will be included in the study.

Exclusion Criteria:

* Diagnosed with arthrogenic or mixed type TMDs,
* Severe psychiatric illness such as schizophrenia,
* Previous vagal nerve stimulation or history of vagotomy,
* Have extensive joint damage affecting the jaw, head, neck and shoulder areas, have a history of major trauma, fracture or surgery to these body parts, or are undergoing radiotherapy,
* Diagnosed with cervical disc herniation, cervical radiculopathy or cervical myelopathy,
* History of cardiac disease and being treated for cardiac problems,
* Active implant users such as pacemakers, defibrillators, neurostimulators, cochlear implants and ventricular shunts,
* Failure to understand the study protocol
* Have a history of progressive neurological diseases (such as Parkinson's disease, MS, ALS, epilepsy, Alzheimer's disease)
* Acute tinnitus
* Skin problems such as dermatitis, infection, psoriasis, urticaria, acne or eczema at the stimulation site,
* Has any anatomical abnormality that prevents successful placement of the ear electrode,
* and reporting acute tinnitus,
* Pregnant subjects will be excluded from the study
Prospective Prostate Cancer and Patient-reported Outcomes Registry

This study aims to evaluate the use of a digital solution, integrated into the electronic health record, for prospective and structured reporting of clinical and patient-reported outcomes for patients diagnosed with localized or locally advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathology confirmed diagnosis of localized or locally advanced prostate cancer
* Being able to speak, read and understand Dutch, French, or English
* Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he understands the purpose of, and is willing to participate in the study.

Exclusion Criteria:

* Patients with prior treatment for prostate malignancies will be excluded.
* Dementia, mental alteration, or psychiatric pathology that can compromise informed consent from the patient and/ or adherence to the protocol and the monitoring of the trial
* Patients who cannot submit themselves to following the protocol for psychological reasons, social, family, or geographical.
* Persons deprived of liberty or under guardianship
Intragastric Injections of Botox for the Treatment of Obesity

One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run.

There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35

Exclusion Criteria:

* Known hypersensitivity to medication
* Neuro muscular disease
* Dysphagia
* Tendency for aspiration
* Ulcus
* Use of aminoglycoside antibiotics and/or spectinomycin lately
* Previous side effects of botox injections
* Previous bariatric surgery
* Previous cancer in GI-tract
* Other obesity treatment last 12 months
* Severe eating disorder
* Hypothyroidism
* Pregnancy/brest feeding
* Reduced competence to consent
Glioblastoma Evaluation for Heterogeneity In RadioseNsitivity

This is an observational study on GBM surgical samples to investigate if increasing doses of radiation therapy could improve the radiation response; and in particular the investigators will assess if there is a correlation between the number of the phosphorylated H2AX nuclear foci and the different dose level of radiation therapy.

Standard of care for newly diagnosed glioblastoma (GBM) patients consists of surgical resection followed by radiotherapy with concurrent and adjuvant Temozolomide chemotherapy. Despite these treatments, the prognosis remains poor. Nevertheless, preliminary data on GBM patients show variable outcomes related to a different treatment response, that could be related to the GBM intrinsic heterogeneity, but also to a different patient sensitivity to radiation therapy.

The assessment of this individual radio-sensitivity may provide valuable data to define more tailored treatment schedules, that could potentially be more effective.

Published studies on small cohort of patients show that a possible system to investigate the tumor radiation sensitivity, is to monitor the cellular DNA damage after tissue irradiation, that correlates with the survival fraction of in vitro tumor cells; the DNA damage could be identified through the quantification of Phosphorylated histone H2AX nuclear foci that correlate with the unrepaired DNA double strand breaks (DSBs).

Based on this background, The investigators designed an observational study on GBM surgical samples to investigate if increasing doses of radiation therapy could improve the radiation response; and in particular they will assess if there is a correlation between the number of the phosphorylated H2AX nuclear foci and the different dose level of radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years
* Patients eligible for diagnostic or therapeutic surgical procedure
* Written informed consent
* Histopathologically confirmed newly diagnosed glioblastoma according to WHO 2021
* Availability of fresh tissue samples

Exclusion Criteria:

* Other extra-cranial cancer
* Non GBM glioma
* Previous brain radiation therapy
Effect of Total Sleep Deprivation on Vascular Function

Insufficient sleep is associated with an increased risk for cardiovascular disease. The causal mechanisms are currently unknown, but may include endothelial dysfunction. The purpose of this study is to examine the influence of sex and aging on the effects of total sleep deprivation on vascular function and whether exercise training attenuates these effects.


Eligibility Criteria:
Inclusion criteria:

* Males and females
* 20 to 30 and 50 to 60 years of age
* Females will be eumenorrheic at enrollment or postmenopausal for at least 1 year
* No major clinical disease (e.g., diabetes, cardiovascular, liver or chronic kidney disease) to minimize confounding of vascular measures
* Participants will be sedentary (≤3x per week of ≤30 minutes of aerobic exercise/session) or trained (≥5x per week of moderate/vigorous aerobic exercise training)

Exclusion criteria:

* Age \<20 or 31 to 49 or \>60 years
* Body mass index ≥30 kg/m\^2 because obesity may affect vascular function
* Use of medication that may affect vascular measures
* Hormone replacement therapy or hormonal contraceptives within past year
* Use of tobacco products (chewing tobacco, traditional or e-cigarettes) because they may influence vascular function
* Being perimenopausal, pregnant or lactating because may influence vascular function
* Being a shift worker because habitual sleep deprivation and altered circadian rhythm may influence vascular function.
* Not having an "intermediate" chronotype based on the Morningness-Eveningness Questionnaire (MEQ; score \<31 or \>69) because this would influence the effect of overnight sleep deprivation on vascular function.
* Sleep complaints based on the Pittsburgh Sleep Quality Index (PSQI; score \>5) because this would influence the effect of overnight sleep deprivation on vascular function.
Cost-efficacy of Sealing Moderate Caries Lesions in Occlusal Surfaces of Primary Molars

This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. Initially, a non-inferiority study was designed in order to verify if sealing could be non-inferior than restoration. In this case, it could be preferable since it is less invasive. Therefore, cost will be put forward into the analysis considering even reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability could be another differential point between treatments.

This study aims to evaluate the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. 96 children aged 3-6 years will be selected. Children must have at least one occlusal surface classified as scores 3 or 4 of International Caries Detection and Assessment System (ICDAS). Children will be randomly allocated according to the treatment: glass ionomer sealant and restoration with glass ionomer. After treatment, teeth will be assessed clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the treatment received. The need of reintervention initially treated, either by failures that require repeating of the same procedure or for progression of caries lesions will be considered as primary outcomes. The secondary outcomes will be the chil's acceptability to the treatment.

Eligibility Criteria:
Inclusion Criteria:

They will be included in this study children:

* aged 3 years and 6 years and 11 months;
* With complete primary dentition;
* Who have at least one active caries lesion score 3 or 4 ICDAS, in the occlusal molars surfaces.
* Who have assented to participate and whose parents have consented to their participation by signing the Instrument of Consent.

Exclusion Criteria:

* who have medical and / or behavioral conditions that require special considerations regarding handling / treatment;
* who are involved in other research that may impact on this study;
* whose parents that not agree in participate.
Non-contrast Cardiac CT as a Risk Stratification Tool in Patients With Non-cardiac Chest Pain

Background:

Only around 20% of all patients seen in hospital with suspected Acute Coronary Syndrome will have Acute Myocardial Infarction. However, several studies indicate that patients where ACS had been excluded by conventional methods sustain a higher cardiac morbidity and mortality than the background population. Not all of these patients can be identified by traditional risk factors such as cholesterol, hypertension, and diabetes or with conventional methods such as ECG, troponin and clinical symptoms. Non-Contrast Cardiac-CT measures the amount of calcification in the coronary arteries and might be a useful addition in predicting future cardiac events in this patient group. The aim of this study is through a double-blinded study to determine whether non-contrast CT scan with calcium score can be used to identify patients at increased risk of death and cardiac event within the following 12 months after an acute admission where troponin measurements were normal.

Methods:

The study will investigate patients with suspected Acute Coronary syndrome who have been examined and subsequently sent home from an emergency- or cardiology department without ACS or another obvious explanation. 750 patients, age 30-70 years who are included in the study: "Identification of risk factors in non-cardiac chest pain patients" will be offered a non-contrast CT scan with calcium score within 14 days after the hospital contact. The participants will be included in a 12 months follow up, where the result of the calcium score is not revealed neither for the patient nor the investigator. After 12 months the results of the scan is compared with the rate of cardiac events. This project is a multicenter study and recruits patients from 6 emergency - and cardiology departments in the region of Southern Denmark.

The study commences at September 2014 and results of this project are expected to contribute to the risk stratification of Non-cardiac chest pain patients.


Eligibility Criteria:
Inclusion Criteria:

* chest pain with normal cardiac enzymes.
* legal competent
* age 30-70 years

Exclusion Criteria:

* chest pain of obvious reason
* previous acute coronary syndrome
* previous coronary artery investigations within last five years
* patients referred for other cardiac examinations after the current admission
Islet Autotransplantation in Patients at Very High-risk Pancreatic Anastomosis

The goal of the proposal is to demonstrate that, in patients with disease of the pancreatic head with very high-risk of complications of pancreatojejunal reconstruction (soft pancreas and pancreatic duct diameter \<3 mm), total pancreatectomy with islet autotransplantation (IAT) is associated with a lower morbidity (in terms of surgical or medical complications) and mortality compared with pancreaticoduodenectomy and pancreatojejunal anastomosis.

Complications of the pancreatic anastomosis still represents a significant risk for death after the resection of the pancreatic head. In an effort to decrease morbidity and mortality, the referral of patients who need a pancreaticoduodenectomy to institutions (and surgeons) performing a high volume of this surgical procedure has been championed. Nonetheless, the role of prophylactic medications and the best surgical technique(s) for the removal of the pancreatic head are still debated. However, very few prospective randomized clinical trials have been conducted to compare different surgical techniques.

Our study will address for the first time the role for preemptive total pancreatectomy and IAT in selected patients undergoing pancreaticoduodenectomy that are considered high risk for pancreaticojejunostomy disruption (eg, small pancreatic duct, soft pancreas). The information expected is the identification of total pancreatectomy and the IAT as the standard treatment in a subgroup of patient with pathologies of the pancreatic head at high risk for leakage of pancreatic anastomosis. Ultimately this project will lead to reserve more innovative cell therapy for patients with the highest risk of anastomosis failure reducing pancreatojejunal reconstruction related morbidity and mortality

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Ability to provide written informed consent
* Mentally stable and able to comply with the procedures of the study protocol
* Fasting glycaemia \<126 mg/dl without glucose-lowering medications.

Exclusion Criteria:

* Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
* Diagnosis of intraductal papillary mucinous cancer, unless the absence of multifocal lesion is demonstrated by endoscopic US
* Presence of multifocal or residual disease at the pancreatic margin.
Allogenic Blood Transfusion During Elective Open Abdominal Aortic Surgery

Open surgery on the abdominal aorta is a high risk procedure associated with an intravascular volume blood loss and thereby, with high requirement for blood and blood product transfusion.

The aim of this study was to establish the rate for allogenic blood transfusion (ABT) during elective open abdominal aortic surgery and find parameters associated with ABT requirements.

Two distinct clinical entities affect the abdominal aorta: abdominal aortic aneurysm (AAA) and aortoiliac occlusive disease (AIOD). These are multifactorial vascular disorders caused by complex genetic and environmental factors. Older patients with more comorbidity are often affected. Open abdominal aortic surgery is associated with high mortality rate. Even in specialised institutions it varies from 2 to 5%. Similar results can be compared to mortality for coronary artery bypass grafting. This reflects the complexity of the surgery and the general health of those patients. It is associated with intravascular volume blood loss and, thereby, with a high requirement for blood and blood products transfusion. Allogenic blood transfusion (ABT) has been associated with an increased risk of tumour recurrence, postoperative infection, acute lung injury, perioperative myocardial infarction, postoperative low-output cardiac failure, and increased mortality.

In the last decades, multiple strategies have been undertaken to prevent massive intraoperative blood loss during elective surgery and allogenic blood transfusion requirement. One of the method advocates a preoperative increase in red blood cells level using B12, folic acid and iron supplements or with erythropoietin usage. Other methods involve the optimisation of surgical technique and the use of a machine for intraoperative blood salvage, known as "cell saver".

The aim of this study was to establish the rate for ABT during elective open abdominal aortic surgery, find parameters associated with ABT requirements, and optimise the investigators hospital's maximum surgical blood ordering schedule (MSBOS).

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Elective open abdominal aortic surgery
* Abdominal aortic aneurysm repair
* Abdominal aortic bypass grafting for occlusive aortoiliac disease

Exclusion Criteria:

* Patients younger than 18 years
* Patients undergoing cardiac surgery
* Patients with ruptured abdominal aneurysms
* Patients undergoing endovascular aortic repair
* Patients submitted to other types of vascular surgery (i.e., carotid endarterectomy or peripheral bypass surgery)
TAP Block With Methyl-prednisolone as a Pain Treatment Modality After Total Abdominal Hysterectomy Procedures

The aim of this work to compare between the efficacy of ultrasound guided TAP block with dexamethasone as an adjuvant versus ultrasound guided TAPB with methyl prednisolone as an adjuvant to local anesthetic for postoperative pain management in lower abdominal hysterectomy procedures.

Patients will be divided in to two groups; TAPB with dexamethasone as an adjuvant to local anesthetic Gr A(n=25) and TAPB with methyl prednisolone as an adjuvant to local anesthetic Gr B(n=25).

By the end of surgery and with the patient in supine position and after covering of surgery site, preparing the skin with povidone iodine, a high frequency (5-10 MHZ) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA) will be placed transversally on abdominal wall between lower costal margin and iliac crest near midline. After identifying the rectus abdominis muscle, we will gradually move the ultrasound probe laterally to identify the transversus abdominis muscle lying posterior to the rectus muscle. A 22 G echogenic needle using the in plane technique will be inserted medially aiming towards the iliac crest, then 30ml total volume of 0.25 plain bupivacaine 1.5mg/kg with lidocaine 1% 3mg/kg with 8mg dexamethasone in group A patients and 30ml total volume of 0.25 plain bupivacaine 1.5mg/kg with lidocaine 1% 3mg/kg with 50 mg methylprednisolone in group B patients.

Vital signs (H.R and non invasive blood pressure) will be recorded at the onset of the block then every 20 min for an hour then every 4hrs for 12 hrs. post operative

Postoperative:

Paracetamol every 8 hours and ketorolac every 12 hours should be given as a part of multimodal analgesia and nalbuphine given as rescue analgesia and included in secondary outcomes

Post-operative assessment and analgesic regimen

Post operative pain assessment using V.A.S will be assessed (0-10) (11) (as zero refer to no pain and 10 refer to the worst pain) after 1h of the block then every 4hrs for 12 hrs. then every 8hrs for 48 hrs then after 72hrs . The patient will be given Paracetamol every 8 hours and ketorolac every 12 hours The time to the first request of rescue post operative analgesic will be recorded, when the patient complain of pain (V.A.S\> 3) intravenous nalbuphine 5mg will be given, total dose of nalbuphine will be recorded /24hrs.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II.
* Age 20-45 years.
* Undergoing lower abdominal hysterectomies.

Exclusion Criteria:

* Patient refusal
* Patients with coagulopathy.
* Hypertensive patients.
* Diabetic patients.
* Morbid obesity
* Allergy to the used drugs