cyrilzakka/clinical-trials huggingface dataset:
A Case Control Observational Study to Assess CYDAR Automated Overlay Guidance During EVAR

This is an observational trial to determine if use of fusion imaging in infrarenal endovascular aneurysm repair will decrease the radiation dose and improve patient safety for this procedure.

The aorta is the main artery of the body. An aortic abdominal aneurysm (AAA) is defined as an abnormal dilatation of the aorta, based on a diameter of 3 cm or more, due to a weakness of the aortic wall that is prone to rupture, leading to a lifethreatening condition.

Once AAA diagnosed, a CTscan is required to assess the anatomy and if indicate an endovascular aneurysm repair (EVAR) is performed. This mini invasive procedure allows the exclusion of the AAA by positioning an endograft inside the aorta through a femoral access under live Xrays (fluoroscopy) guidance.

The Xrays are good at showing bones and radioopaque endovascular tools, but they do not show soft tissues like the aorta, and they produce flat (2D) images that superimpose all the 3D anatomical features. In order to see the aorta, physicians have to inject iodinated contrast during high quality imaging recording. One way to improve clinicians' perception of peroperative 3D vascular anatomy is to accurately overlay selected information from the preoperative CT scan (a 3D vascular mask) onto the live Xray image creating a '3D roadmap'. This advanced imaging application is currently available only in the latest expensive hybrid rooms. This trial will examine the clinical benefits of the first advanced imaging application allowing automated 3D overlay guidance during EVAR in any theatre. The software, combined with secure and certified cloud high performance computing, deduces the patient position from comparing the bony anatomy visible on the Xray to that on the patient's CT scan, enabling it to produce and update accurate and reliable overlays of the diagnostic CT 3D vascular mask throughout the operation (www.cydar.co.uk). Expected benefits include reducing the total Xray exposure of the patients and staff, reduced use of iodinated contrast (a major cause of kidney failure) and shortening procedure duration.

Eligibility Criteria:
Inclusion Criteria:

1. willing and able to give informed consent,and
2. aged 18 or older, and
3. been scheduled for endovascular repair of an infrarenal aortic aneurysm (EVAR), and
4. who have had a preoperative diagnostic CT scan, and
5. able (in the investigator's opinion) and willing to comply with the study requirements.

Exclusion Criteria:

1. Female participants who is pregnant or planning pregnancy during the course of the study.
2. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
3. Any patient requiring an associated procedure (iliac branch device implantation, renal or mesenteric angioplasty)
4. Ruptured AAA and emergency procedures
Intraocular Pressure Data Collection With Tonometers

The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years).

The intraocular pressure of the participants will be measured with four different tonometers.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

Exclusion Criteria:

* Subjects with only one functional eye
* Subjects having poor or eccentric fixation in the study eye(s)
* High corneal astigmatism \&gt;3D in the study eye(s)
* Central corneal scarring
* History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
* Microphthalmos
* Buphthalmos
* Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
* Dry eyes (clinically significant)
* Lid squeezers - blepharospasm
* Nystagmus
* Keratoconus
* Any other corneal or conjunctival pathology or infection relevant to this study
* Cataract Extraction within last 2 months in the study eye(s)
Effect of Ultrasound Guided Thoracic Interfascial Plane Block Versus Erector Spinae Plane Block After Mastectomy

This study will be conducted to compare the efficacy of ultrasound guided thoracic interfascial plane block versus ultrasound guided erector spinae plane block on acute and chronic pain after modified radical mastectomy surgery.

Various thoracic nerve blocks performed for pain control after breast cancer surgery provide superior analgesic effect and reduce postoperative nausea and vomiting as a result of the decreased use of opioid analgesics.

Ultrasound-guided erector spinae block (ESB) is a regional anesthesia technique; recently described by Forero et al, in management of thoracic neuropathic pain. It became popular because it is much safer and easily administered than other alternative regional techniques as paravertebral and thoracic epidural block.

ESB leads to effective postoperative analgesia when performed at T 4-5 level for breast and thoracic surgery, and T 7 level for abdominal surgeries. Spread of local anesthetic following ESB in the cephalic and caudal directions can lead to analgesia from C7 to L2-3.

There have been several reports that thoracic interfascial plane block is useful for multimodal analgesia in patients undergoing mastectomy, Thoracic interfascial plane block including pecto-intercostal fascial plane block (PIFB) and serratus intercostal fascial plane block (SIFB).

Thoracic interfascial plane block is the peripheral nerve block that targets the intercostal nerves branches distributed in the chest and axilla, Although PIFB and SIFB are thought to be relatively easy to perform there have been no reports of the simultaneous performance of the two blocks.

Eligibility Criteria:
Inclusion Criteria:

* Female patients admitted for modified radical mastectomy surgery.
* American Society of Anesthesiologists (ASA) physical activity I, II
* Aged (18 - 65) years

Exclusion Criteria:

* Patient refusal.
* Patient with neurological deficit.
* Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant, and antiplatelet drugs).
* Uncooperative patient.
* Infection at the block injection site.
* Patients with a history of allergy to drugs.
Effects of Dietary Fiber on Affective Processes

The effects of dietary fiber on psychobiological processes are examined in a sample of healthy volunteers.

The study is an interventional triple-blind, placebo-controlled, parallel group design with 2 arms (placebo, dietary fiber). Healthy male participants adhere to their normal eating habits for the duration of the study (32 days). At the baseline study visit, measurements are taken in the lab, including biological samples and psychophysiological measurements. Participants then consume placebo or dietary fiber for 4 weeks and revisit the lab on day 32 for a second measurement of the outcomes of interest. Specifically, we investigate the effect of dietary fiber on affective processing, including stress sensitivity and fear-related processes (e.g. extinction learning). Volunteers also respond to questionnaires in relation to mood and GI symptoms, and provide biological samples (saliva, blood, faecal, and urine samples) for analysis of cortisol levels, circulating short chain fatty acids and serum BDNF, faecal SCFA and microbiota composition, and intestinal permeability, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Male participants
* Age range 20-40 years
* BMI range 18.5-27
* Dutch or English as native-language

Exclusion Criteria:

* previous or current neurological, psychiatric, gastrointestinal or endocrine disorders, or other relevant medical history
* current or recent regular medication use
* previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
* one or more diagnoses based on the mini-international neuropsychiatric interview
* smoking
* night-shift work
* adherence to vegan or vegetarian diets
* use of pre- or probiotics within one month preceding the study
* use of antibiotics within 3 months preceding the study
* Habitual diet not exceeding consumption of 25 g of dietary fiber per day
* previous experience with one of the tasks used in the study
Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients

The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant recipients. The study also aims to identify the target ranges of levels of cyclosporine microemulsion in the blood.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 months post-transplant
* At least one of the following: stable or deteriorating kidney function, high blood pressure, high lipids, high glucose
* Receiving stable doses of cyclosporine microemulsion for the past 3 months

Exclusion Criteria:

* - Severe rejection within the past 3 months
* Severe kidney dysfunction
* Transplanted for hepatitis C or autoimmune hepatitis

Other protocol-defined exclusion criteria applied
Comparison of the Effects of Two Different Local Anesthetics Used in Spinal Anesthesia

Objective: This study aimed to compare the effects of two different local anesthetics with different baricity used in spinal anesthesia on thermoregulation.

Materials and Methods: The study was conducted on forty full-term pregnant women scheduled for elective cesarean sections under spinal anesthesia. At an operating room temperature of twenty-four degrees Celsius, peripheral body temperature was measured using temperature probes attached to the lower medial parts of the same side's lower and upper extremities, and central body temperature was measured with a tympanic thermometer. Isobaric levobupivacaine and hyperbaric bupivacaine were used in spinal anesthesia applications. After spinal anesthesia, tympanic temperature, arm and leg temperatures, mean arterial pressure, heart rate, and oxygen saturation were measured and recorded at baseline, the first, third, and fifth minutes, and every five minutes thereafter until the end of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Term pregnant with elective cesarean section planned under spinal anesthesia
* ASA I-II
* 18-40 years old

Exclusion Criteria:

* patients in whom spinal anesthesia is contraindicated,
* patients with neuromuscular disease,
* alcohol and substance abusers,
* patients with a body mass index (BMI) \<18.5 kg/m² or \>35 kg/m²,
* those taking medications that may affect thermoregulation such as vasodilators,
* patients with thyroid disease,
* patients with fever and infection,
* patients with known allergies to study drugs.
Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis

The purpose of this study is to use the proteomic analysis of synovial fluid to perform the comprehensive investigation of the biomarker that will be useful to assign the tratment effectiveness of five weekly intra-articular HA injection.

The intra-articular injection with HA is an accepted therapy for OA. However, the exact regulation of HA treatment is unclear. Compared the expression SF proteome from OA patients who received HA/800 treatment or not (post and pre-HA treatment) may be possible to identify the protein that response to the HA treatment and apply this to prognosis of OA. We used two-dimensional difference gel electrophoresis (2D-DIGE) combined with matrix-assisted laser desorption ionization time of light mass spectrometry (MALDI-TOF) to determine the differentially displayed proteins in human SF. Finally, we used Western blotting and ELISA analysis to validate the potential biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of osteoarthritis
* Accept the intra-articular HA injection therapy

Exclusion Criteria:

-
HR Versus RFA for Early Stage HCC

Hepatocellular carcinoma (HCC) is the third leading death cancer in the world. It is important to explore a safe and effective therapy for early-stage HCC. Previous studies reported that radiofrequency ablation (RFA) has higher efficacy and is associated with fewer complications and shorter hospital stays than hepatic resection (HR) for early-stage HCC. However, meta-analysis and systematic review found that RFA is associated with higher recurrence rate and lower long-term overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Clinical diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
* Tumor stage fitted into Milan Criteria
* Patients have Child-Pugh A liver function
* No previous neoadjuvant treatment
* No evidence of metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
* No malignancy other than HCC for 5 years prior to the initial HCC treatment
* No history of encephalopathy, ascites refractory to diuretics or variceal bleeding

Exclusion Criteria:

* History of cardiac disease:

  * Congestive heart failure \> New York Heart Association (NYHA) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted);
  * Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; or
  * Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
* Active clinically serious infections ( \> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events version 3.0)
* Known history of human immunodeficiency virus (HIV) infection
* Known Central Nervous System tumors including metastatic brain disease
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
* History of organ allograft
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
* Excluded therapies and medications, previous and concomitant:

  * Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC

The purpose of this study is to determine whether low-dose peg-interferon plus ribavirin therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had the curative resection of primary HCC.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Hepatocellular carcinoma due to Chronic Hepatitis C Virus Infection.
* Must be treated with curative treatment for primary tumor using either surgical resection or radiofrequency ablation therapy

Exclusion Criteria:

* No recurrence of hepatocellular carcinoma 3 months after the primary treatment
* Renal dysfunction
Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants

In June 2024, the German Standing Committee on Vaccination (STIKO) recommended the universal immunization of infants with nirsevimab during their first RSV season. Nirsevimab is a long-acting monoclonal antibody designed to provide passive immunity against RSV, significantly reducing the risk of severe RSV disease in infants. This recommendation marks the 2024/25 season as the first in which nirsevimab is broadly implemented for all infants in Germany.

Despite the introduction of this new prevention measure, there is currently no timely monitoring system for immunization rates. Understanding the uptake and coverage of nirsevimab is crucial for evaluating its impact on public health and guiding future vaccination strategies. Therefore, this study aims to monitor the national immunization rates of nirsevimab in children under one year of age during the initial seasons of its widespread use.

The primary objective of this study is to determine the Nirsevimab immunization rate in eligible infants in their first RSV-season in Germany. The study will focus on:

1. Assessing the immunization rates among eligible infants (according to STIKO recommendation) in their first RSV-season in Germany (i.e. across all geographies)
2. Assessing the immunisation rates among the "catch-up cohort", i.e. all infants born between April and September. For these infants, the STIKO recommends immunization with nirsevimab in early autumn.
3. Assessing the immunization rate among the "in-season cohort", i.e. all infants born during the RSV season between October and March. For these newborns, the STIKO recommends immunization with Nirsevimab shortly after birth, preferably during the second "well-baby visit" at the age of 3-10 days of life.


Eligibility Criteria:
Inclusion Criteria:

* Be a parent of an infant born between April 2024/25/26 and March 2025/26/27, respectively
* Reside in Germany at the time of survey completion
* Be at least 18 years old at the time of survey completion.
* Agree with privacy policy and AE (Adverse Event) reporting requirements before proceeding with the survey.
* Read and agree to the ICF (Informed Consent Form) by ticking a box before proceeding with the survey.

Exclusion Criteria:

* Participation in the study (= completed the survey) in a previous wave of the current season.

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.

The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers.

The goal of this study is to pilot and evaluate a telemedicine medical abortion (TMA) service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers. Providers will provide counseling by phone or video about pregnancy options and give detailed information about the medical abortion process, expected side effects, and where to seek additional care. The provider will then evaluate the woman's eligibility for TMA service by following the no-test protocol and discuss at-home follow-up using a symptom checklist and a high-sensitivity urine pregnancy test. If pre-treatment tests are needed, women will be referred to a nearby diagnostic center and test results will be forwarded to the study provider. Participants will receive medications by mail or courier service or pick them up at the pharmacy or study clinics, take medications as instructed, and complete at-home follow-ups as discussed with the provider.

Eligibility Criteria:
Inclusion Criteria:

* Is pregnant as determined by a pregnancy test or ultrasound (if obtained prior to contacting the study site)
* Has no contraindications to medical abortion
* Has access to a phone
* Is able to take mifepristone on or before 63 days gestation

Exclusion Criteria:

* Medically ineligible for medical abortion
* Gestational age above 63 days based on LMP
Clinical and Biological Database in Colon Cancer and Colic Tumors

Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.

As the second leading cause of cancer-related death in France, colorectal cancer is a major public health problem. Each year, 37 000 cases are newly diagnosed in France and 17 000 patients die of the disease.

Colorectal cancer is due to molecular and genetic damages involved in all tumorigenesis steps, transition from healthy tissue to adenoma and finally to invasive carcinoma stage. The investigators hope that a to better understand tumor invasion and metastatic scattering processes will allow therapeutic innovation and the emergence of new biomarkers.

However, the study of early tumorigenesis phases as well as advanced stages of the disease is currently limited due to a lack of tissue samples.

In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection dedicated to the tissular and blood samples of patients with colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patient undergoing colon cancer surgery (stage I, II, III and IV)
2. Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer
3. Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),
4. Patient with familial polyposis eligible for colectomy
5. Age \> 18 years
6. Signed informed consent

Exclusion Criteria:

1. Patient not affiliated to Social Protection system
2. Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
3. Patient under guardianship
4. Minor patient
A Pharmacodynamic Study With Ticagrelor in African American Patients

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American patients with stable coronary artery disease.

A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in African American Patients with Stable Coronary Artery Disease

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent before initiation of any study-related procedures
* Male or female patients aged 18 years or older
* Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
* Females must be post menopausal or surgically sterile Self-identified as African American

Exclusion Criteria:

* Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
* Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
* Current smokers, including the use of tobacco containing products in the past 1 month of randomization Patients required dialysis