cyrilzakka/clinical-trials huggingface dataset:
Platelet Inhibitor Treated Patients with Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ?

At the emergencies rooms, patients with head trauma meeting one of the NICE criteria, which include antiplatelet inhibitors treatment, are considered as patients with a risk of cerebral haemorrage and are taken systematically for a CT-scanner.

However, there are more and more antiplatelet inhibitor's patient with minor head injury traumas seen at the emergencies room and the efficiency of this NICE criteria is controversial on litterature.

This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors is a sufficient condition to eliminate a cerebral haemorrhage for patients with head injury traumas, and conversely, that antiplatelet inhibitors treatment would not be by itself an indication for a CT-scanner.

Head injuries are a frequent reason for emergency services, and according to studies, they represent between 5% and 10% of patients treated in emergencies. Among them, 90% are minor head injury traumas. NICE criteria has been defined to establish patients who need a CT-scanner because of a risk of cerebral haemorrhage.

NICE criteria include several conditions including taking antiplatelet inhibitors. However, the real risk of cerebral haemorrhage for theses cases is controversial in litterature. In parallel, more and more patients undergoing antiplatelet inhibitor's treatment are seen in emergencies after a head injury trauma.

In routine protocol at the emergency rooms, these patients are seen for a clinical exam and next submitted to a CT-scanner. If the clinician can't detect a cerebral haemorrage, the patient will return at home.

This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors treatment is a sufficient condition to eliminate a cerebral haemorrhage for patients with head injury traumas, and conversely, that antiplatelet inhibitors treatment would not be by itself an indication for a CT-scanner.

This is a diagnostic, case-only, prospective, multicenter study with a blinded primary outcome measure assessment.

As described in routine protocol, in this study antiplatelet inhibitor's patients with head injury trauma will be seen for a clinical exam and next submitted to a CT-scanner. After a month, patient will be called by the clinical center to ask about morbidity and mortality. Especially, clinicans will report on the emergence of a cerebral haemorrhage during this month.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Patient with a head injury trauma, described by the patient or seen at the clinical exam
* Glasgow score between 13 and 15 at the clinical exam
* Current treatment with antiplatelet inhibitors
* Informed non opposition form signed

Exclusion Criteria :

* Absence of CT-scanner
* Patients with double anti-platelet aggregation
* Patients on anticoagulants
Neuromuscular Ultrasound for Focal Neuropathies

The purpose of this study is to determine if a new diagnostic technique, called neuromuscular ultrasound, can improve our ability to diagnose focal nerve disease.


Eligibility Criteria:
Inclusion Criteria:

* Electrodiagnostic finding of focal nerve disease
* Age 18 and older

Exclusion Criteria:

* Skin lesions preventing ultrasound
* Known ultrasound gel allergy
* Unable to complete 6 months of follow-up
Dapagliflozin vs Empagliflozin on Flow Mediated Dilation in Type 2 Diabetes Mellitus

Type 2 diabetes mellitus (T2DM) is a considered one of the main global health challenges; the vascular endothelium plays an important role in vascular dysfunction in DM; Hyperglycemia induced by it is recognized as the main factor for the development of vascular complications of the disease, secondary to a reduction in nitric oxide production; "flow-mediated dilation" is the most commonly used technique for the evaluation of endothelial function, being the non-invasive method most widely used. It has been reported that with the use of SGLT2 inhibitors the development of cardiovascular complications in patients with T2DM is a decrease, as well the arterial stiffness, endothelial dysfunction and increasing on the shear stress and blood viscosity; and experimentally.

The objective of this study, is to evaluate the acute effect of the administration of dapagliflozin in comparison with the administration of empagliflozin on endothelial disfunction in individuals with T2DM; we will conduct a double-blind, randomized, placebo-controlled, trial with 3 groups, each group of 24 male and female patients, between 40-65 years of age with T2DM, without hypertension, treated with insulins or thiazide diuretics. Randomization will determine who will receive the intervention during 7-days trial (Empagliflozin 25 mg 1 time daily 5 minutes or Dapagliflozin 10 mg before the first bite of each meal or approved placebo capsules), the patients will also continue with their usual treatment. The clinical findings and laboratory test and laboratory test include a metabolic profile and biosafety, baseline and at 7 days. Body weight, body fat, body mass index (BMI) and blood pressure will be determined during the initial and final visit, likewise, hemodynamics parameters of endothelial disfunction by flow mediate dilation with a high-resolution UNEX EF38G® ultrasound. Adverse events to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. A p \<0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM
* HbA1c \> 7 y \< 10
* BMI 25 - 34.9 kg/m2
* Signature of consent under information

Exclusion Criteria:

* Hypertension
* Treated with insulin and / or loop diuretics and thiazides
* T1DM
* Hypotension
* With any autoimmune disease
* Liver disease
* Women who do not have a safe method of contraception
* Women who are taking oral contraceptives or under treatment with hormone replacement therapy
* Woman pregnant or breastfeeding
* Untreated thyroid disease
* Patients with a cardiovascular disease that contraindicates the use of this pharmacological class
* Glomerular filtration rate \<60ml/min (Cockcroft-Gault)
Self-Management of Cancer-Related Fatigue by Adolescents

This study will investigate self-management of cancer-related fatigue by adolescents through pilot study of an evidence based educational resource.

Cancer-related fatigue is a prevalent and distressing symptom which has a significant impact on quality of life for children and adolescents with cancer and their families. Evidence based guidelines issued by the Oncology Nursing Society and National Comprehensive Cancer Network recommend educational interventions for preventing and treating cancer-related fatigue.The primary study aim is to examine the relationships among: intensity of cancer-related fatigue; frequency of use of an evidence based educational resource for self-management of cancer-related fatigue; and perceived helpfulness of resource use. The secondary aim is to examine the relationship between the Fatigue Scale-Adolescent (FS-A) and the Symptom Distress Scale (SDS) 'tired' item as measures of intensity of cancer-related fatigue. The tertiary aim is to examine the feasibility of recruiting and retaining adolescents with cancer for longitudinal study of cancer-related fatigue.

Eligibility Criteria:
Inclusion Criteria:

* adolescents 13-18 years inclusive
* leukemia, lymphoma, or malignant solid tumor; newly diagnosed and within 2 weeks of initiating therapy
* patient and consenting parent able to speak, read, and write English.

Exclusion Criteria:

* failure to meet all of inclusion criteria
Shared Online Health Records for Patient Safety and Care

The study uses a randomized, prospective cohort design to assess the impact of shared online health records on 1) patient safety, 2) health goal adherence and outcomes, 3) documentation of family history, and 4) barriers to the adoption of patient-physician communication technology.

Hypothesis: the respective interventions will result in 1) improved patient safety 2) greater adherence to health care maintenance and chronic disease guidelines 3) more accurate documentation of family history 4) the identification of technology adoption enablers and barriers.

During the first phase of the study, primary care practice patients continue to receive "usual care" while their physician's offices are using Patient Gateway, an Internet portal offering secure messaging, common requests, chart information, and health information that has already been developed. Also in this first phase, all patients using Patient Gateway will receive an electronic letter explaining the research study and a link to an electronic consent form. In addition to recruitment of subjects, phase 1 allows for baseline data to be collected.

In the second phase, study clinics will be randomized into one of two intervention "arms". Study subjects whose clinics are randomized into Arm 1 will be invited to review and comment on their medication, allergy, and diabetes information through Patient Gateway; they can then submit this information to their primary care physician for review. Those randomized into Arm 2 will report on their health maintenance status and family history and submit this information to their primary care physician through Patient Gateway prior to a scheduled visit. Chart reviews performed at the end of Phase 1 and Phase 2 will be conducted to identify differences in process measures and outcome measures between intervention and control groups.

In addition, a medication phone survey sub-study will be conducted to evaluate the effect of the new Patient Gateway features on medication management.

Eligibility Criteria:
Inclusion Criteria:

* All patients, who are enrolled in Patient Gateway, of physicians and practices participating in the study.

Exclusion Criteria:

* Any patients who are not enrolled in Patient Gateway or do not belong to a participating practice.
KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children

This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.


Eligibility Criteria:
Inclusion Criteria:

* Be a candidate for routine, uncomplicated cataract surgery

Exclusion Criteria:

* Have a post-traumatic cataract.
* Have suspected permanent low vision or blindness in the fellow non-study eye.
* Have active uveitis in either eye.
* Have an ocular neoplasm in either eye.
* Have the presence of viral, bacterial, or fungal disease in either eye.
* Have glaucoma, ocular hypertension, steroid-induced IOP (intraocular pressure) rise or elevated IOP
Modelling in the Quantitative Analysis of Brain PET Scans in Patients With Alzheimer's Disease

PET/CT scans with 18F-FDG can be carried out for the detection of neurodegenerative diseases with hypometabolisms characteristic of the pathologies sought. The diagnosis is given by the clinician after a visual analysis of the data. To complete the diagnosis, a semi-quantitative analysis of the images is recommended (European recommendations) in addition to the visual analysis.

PET/CT scans with 18F-FDG can be carried out for the detection of neurodegenerative diseases with hypometabolisms characteristic of the pathologies sought. The diagnosis is given by the clinician after a visual analysis of the data. To complete the diagnosis, a semi-quantitative analysis of the images is recommended (European recommendations) in addition to the visual analysis.

PET technology is improving from year to year thanks to the arrival of a new PET technology called digital. In addition, correction methods have been developed to improve PET images and thus improve the detection of different pathologies in PET.

The PSF (Point Spread Function) tool enables partial volume effects to be corrected. The PSF consists of correcting the impulse response of the system, and allows a visual improvement of the images. Currently not recommended in brain PET/CT reconstructions, it remains to be evaluated for the quantitative analysis of acquisitions.

Eligibility Criteria:
Inclusion Criteria:

* Brain PET/CT scans at 18F-FDG of patients with Alzheimer's disease carried out in the nuclear medicine department of the Nancy-Brabois University Hospital since December 2017 on digital PET devices.

Exclusion Criteria:

* Patients who have expressed their opposition to the use of their data (poster in the service).
Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma

Recent literature shows that birth injury is associated with postpartum pelvic floor dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor, namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal sphincter rupture and fecal incontinence. In addition, it is associated with increased maternal and neonatal morbidities including increased risk of lower genital tract lacerations. In an effort to shorten labor and decrease lower genital tract trauma many techniques have been investigated.

The objective of our study is to investigate whether the use of obstetric gel shortens the first and second stage of labor and exerts a protective effect on the lower genital tract. Neonatal and maternal morbidities will be also assessed.

The study design will be a randomized controlled trial of 2 groups, where the patients presenting for vaginal delivery will be randomly assigned to either:

* Group 1 who will receive the standard care during labor and delivery
* Group 2 who will receive the standard care during labor and delivery with the vaginal application of the obstetrical gel The goal of this randomized controlled study is to compare the length of the first and 2nd stage of labor and the lower genital tract integrity in the 2 groups of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years
* Intended vaginal delivery
* Singleton baby in vertex presentation
* Low risk pregnancy at term (37-42 weeks of gestation)
* Estimated birth weight between 2000 g and 4500 g (clinically or by sonography)
* Signed written informed consent

Exclusion Criteria:

* Contraindications for vaginal delivery (placenta previa, active herpes infection, etc...)
* Advanced cervical dilation (≥ 5 cm)
* Suspected amniotic infection (fever, foul smelling discharge, fetal tachycardia, abdominal pain)
* Non reassuring fetal heart tracing
* Prolonged rupture of the membranes (24 hours)
* Suspected major fetal malformations
* Suspected cephalopelvic disproportion
Mulligan Technique on Shoulder Dysfunction

76 patients suffering from shoulder dysfunction following neck dissection surgeries will participate in this study. The participants will be selected from Damanhur Oncology Center and randomly will be distributed into two groups.

Group (A): 38 patients will receive MWM in plus traditional physiotherapy program 3 sessions per week for 6 weeks.

Group (B): 38 patients will receive traditional physiotherapy program 3 sessions per week for 6 weeks.

1) Subjects: 76 patients suffering from shoulder dysfunction following neck dissection surgeries will participate in this study. The participants will be selected from Damanhur Oncology Center and randomly will be distributed into two groups.

Group (A): 38 patients will receive MWM in plus traditional physiotherapy program 3 sessions per week for 6 weeks.

Group (B): 38 patients will receive traditional physiotherapy program 3 sessions per week for 6 weeks.

The participants will be selected from Damanhur Oncology Center and randomly will be distributed into two groups equal in number.

2) Equipment:

Therapeutic equipment:

* Mulligan Mobilization Technique: to increase shoulder flexion, abduction, external rotation
* Traditional physical therapy program:

Measurement equipment:

* Digital Goniometer
* Shoulder Pain and Disability Index

Eligibility Criteria:
Inclusion Criteria:

* Patients' age will be between 30-50 years old.
* Both gender 76 patients will participate in this study.

Exclusion Criteria:

* Patients with rotator cuff tears and other shoulder ligament injuries or tendon calcification.
AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia

This project investigates intentionally hypotensive management such as NTG (nitroglycerin) or NTG+Trandate during general anesthesia in patients undergoing orthognathic surgery. Throughout the entire surgical procedure, blood biochemical and urine monitoring will be conducted. Serum creatinine (Cr) levels, urine analysis, and perioperative monitoring will be utilized as indicators for assessing renal function during the surgery. The objective is to assess its potential renal injury and identify early risk factors for acute kidney injury (AKI). Timely recognition of these factors will allow for the implementation of appropriate intervention strategies, aiding in the prevention of postoperative acute kidney injury. This approach contributes to achieving the goals of Enhanced Recovery After Surgery (ERAS) for surgical patients, promoting faster postoperative recovery.

Orthognathic surgery is currently a common procedure in oral and maxillofacial surgery. The facial region is composed of a complex and dense vascular network, requiring precise, accurate, and delicate surgical techniques on both hard and soft tissues. During intraoral procedures, the surgical field may be limited, making the management of surgical bleeding challenging. Controlled hypotension or hypotensive anesthesia is often employed during major maxillofacial surgeries to optimize conditions. Lowering blood pressure is advantageous as it helps reduce overall blood loss and improves the surgeon's visibility. Therefore, maintaining stable blood pressure within the ideal range during the surgical process is a critical anesthesia objective.

This research emphasizes the prevention of acute kidney injury (AKI) in patients undergoing orthognathic surgery with intentional hypotension during general anesthesia. The goal is to detect the potential renal damage at an early stages, before a significant decline in kidney function occurs, thereby reducing the likelihood of acute kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* America society anesthesiologist classification class I to II patients undergoing oro-maxillo-facial surgery
* unlimited mouth opening

Exclusion Criteria:

* patients with arthritis with limited mouth opening
* persistent liver dysfunction
* chronic renal insufficiency
* body mass index ≧35 kg/m2.
* past history of malignant hyperthermia or personal or family history
* diabetes with insulin treatment
* essential hypertension without controlled
Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies

The first purpose of this study is to test a new computer program that reduces the blurring in the cone-beam CT scan and helps the doctor to better locate the tumor. The investigators want to find out what effects, good and/or bad, that this has on the patient and the way we treat the cancer in the lungs.

The second purpose of this study is to test how well this computer program tracks markers in the images, compared to using radio signals to follow the markers.


Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of malignancy suitable for thoracic radiation therapy
* Patient is planning to undergo radiation therapy for primary or recurrent malignancies of the lung or metastatic malignancies to the lung.
* Age ≥ 18 years old
* Karnofsky Performance Status ≥ 60%
* At least part of the tumor must be visible as observed in a diagnostic or planning CT.
* Able to have bronchoscopic placement of Calypso transponders as confirmed on a recent (within the past 8 weeks) CT scan.

Exclusion Criteria:

* Patients with clinically significant active infections.
* Bronchiectasis in the region of the intended implantation.
* History of hypersensitivity to nickel.
* Other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.
* Deemed unable to safely undergo or tolerate flexible bronchoscopy as per institutional guidelines
* Unable to tolerate anesthesia or sedation
* Enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.
* Female patients who are pregnant or nursing

Exclusion criteria for Calypso transponders:

* Implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which Calypso Medical considers will interfere with the Calypso System's electromagnetic localization.
* Active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effects of the Calypso System operation on these devices are unknown.
* Patients whose lung tumors are being monitored by MR imaging as part of standard clinical care. Implantation of transponders will degrade MR images.
* Posterior lesions that would be \>19 cm distance from Calypso detector plate.
Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality

In the present project we propose to deeply characterize nuclear and/or mitochondrial DNA in embryo culture medium, in order to investigate whether both cell-free nucleic acid types may provide additional, reliable, predictive parameters for embryo viability and implantation potential.


Eligibility Criteria:
Inclusion Criteria:

* We will enroll in the study only embryos obtained from fresh gametes. It is to note that we currently transfer more than one embryo (with a maximum of 3, according to patient's age) and we will follow such criteria alongside the project. Consequently, we will take into consideration this aspect in correlating DNA parameters with embryo's outcome.

Exclusion Criteria:

* We will exclude cryopreserved embryos, in order to avoid potential biases due to cooling/defrosting procedures.