cyrilzakka/clinical-trials huggingface dataset:
Argatroban Plus r-tPA for Posterior Circulation Infarction（AR-PCI）

Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurofunction prognosis of thrombolytic patients has been a hot topic in the world.

Recent studies have found that the combined application of argatroban and rt-PA in the treatment of acute anterior circulation infarction might improve the clinical prognosis and not significantly increase bleeding. Some studies have reported that the combined application of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion after opening.

Based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-PA in the treatment of acute posterior circulation infarction.


Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old;
2. Diagnosis of posterior circulation ischemic stroke;
3. Time from onset to treatment ≤6 hours;
4. NIHSS: 4-25;
5. Signed informed consent by patient self or legally authorized representatives.

Exclusion Criteria:

1. mRS≥2;
2. History of stroke within 3 months;
3. History of intracranial hemorrhage;
4. Suspected subarachnoid hemorrhage;
5. Intracranial tumour, vascular malformation or arterial aneurysm;
6. Major surgery within 1 month;
7. Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
8. Platelet count \< 105/mm3;
9. Heparin therapy or oral anticoagulation therapy within 48 hours;
10. Abnormal APTT;
11. Thrombin or Xa factor inhibitor;
12. Severe disease with a life expectancy of less than 3 months;
13. Blood glucose \< 50 mg/dL (2.7mmol/L);
14. Patients who have received any other investigational drug or device within 3 months;
15. Pregnancy;
16. Researchers consider patients inappropriate to participate in the registry.
Comparative Study of Phototherapy for Hyperbilirubinemia

Hyperbilirubinemia is a common problem for term and preterm newborns in intensive care nurseries around the world. It is a condition in which there is too much bilirubin in the blood. Bilirubin is a substance that is naturally released when red blood cells break down. In the early newborn period, multiple factors lead to an abnormally elevated bilirubin level. Large amounts of bilirubin can circulate to tissues in the brain and may cause seizures or brain damage. About 6.1% of term newborns and a higher percentage of preterm newborns develop hyperbilirubinemia that requires treatment. Initiating treatment depends on many factors, including the cause of the hyperbilirubinemia, the level of serum indirect bilirubin, the rate of indirect bilirubin rise, and the age of the patient. The goal of treatment is to keep the level of bilirubin from rising to dangerous levels.

The bilirubin molecule absorbs light. Therefore, treatment of hyperbilirubinemia involves exposure of the baby's skin to special blue spectrum light. Phototherapy is globally recognized as the standard of care for treatment of elevated indirect hyperbilirubinemia in the neonatal period. This light exposure converts water-insoluble indirect bilirubin to a more easily excreted soluble molecule. Over the last five years, several devices have been introduced that emit high intensity light in the blue portion of the visible light spectrum. However, despite frequent use of such therapy, the effectiveness of different phototherapy devices has not been adequately compared. The objective of this study is to compare the efficacy of the blue LED fiberoptic phototherapy with the metal halide spot phototherapy versus blue LED bank light phototherapy versus a combination of tandem therapy on lowering to total serum bilirubin.


Eligibility Criteria:
Inclusion Criteria:

* \> 23 0/7 weeks gestation
* \> 500 grams
* Non-hemolytic or presumed physiologic jaundice (within the first 14 days of life)

Exclusion Criteria:

* Known congenital infection (proven bacterial or viral etiology)
* Known hemolytic diseases such as but not limited to ABO or Rh incompatibility, minor blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, or hereditary red blood cell membrane defects (Coombs or DAT positive)
* Suspected genetic, syndromic, or hepatic disorder-
A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk

Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.

Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.

Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
* Male and female adults, 18 to 60 years.
* Written informed consent obtained from the subject.
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.

Exclusion Criteria:

* Acute disease at the time of enrollment.
* Any confirmed or suspected immunosuppressive condition
* Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* A history of any demyelinating disease including Guillain-Barré syndrome.
* Presence of an active neurological disorder.
* Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
* Receipt of an influenza vaccine within 6 months prior to study enrollment.
* Administration of any vaccines within 30 days prior to study enrollment or during the study period.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
* Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
* A history of severe adverse reaction to a previous influenza vaccination.
* Lactating/nursing female.
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients

Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Breast Cancer

Exclusion Criteria:
Observational Registry Study of Renal Transplant Patients

The MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing detailed clinical data, the study describes recent important changes in surveillance testing and drug therapy and relates these changes to short and long-term outcomes. Also, the study measures patient compliance over time and details the rationale for modifications of MPA dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide information on era changes in transplant practices and their impact on clinical outcome, new insights on optimizing regimens for discrete patient subsets and new perspectives on the optimal use of MPA therapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* The de novo recipient of a cadaveric or living donor kidney transplant, within two weeks of transplantation.
* Receiving mycophenolic acid (MPA) therapy of either myfortic® or CellCept®.
* Able to provide informed consent.
* Able to self-administer the ITAS compliance instrument (6 questions).

Exclusion Criteria:

* The recipient of multiple organ grafts or prior non-kidney graft.
* Enrolled or plans to enroll in an investigational clinical trial.
* Not likely to have up to 5 year follow-up data available for this study.
Local Anesthesia for Facial Fractures

The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative facial fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence.

Effective pain management is critical to successful postoperative care and is known to decrease patient morbidity, incurred patient and hospital costs, and length of hospital stay. Pain and nausea after surgery for traumatic facial fractures can limit patients' early morbidity, oral intake, and ability to communicate.

The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative mandibular or midface fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence. The primary outcome measure is the amount of opioid that patients receive in PACU in morphine milligram equivalent (MMEs).

The purpose of the study is to define whether a perioperative bupivacaine nerve block results in a decrease in the amounts of opioids and antiemetics that patients receive in PACU after CMF trauma surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18 and over
2. Isolated facial fracture to the mandible and/or midface undergoing surgical repair
3. No allergy to local anesthetic
4. Ability to read, write, and understand English

Exclusion Criteria:

1. Patients under the age of 18
2. Isolated nasal bone fracture
3. Polytrauma (I.e. injury pattern resulting in hospital admission for multiple bony fractures outside of the face)
4. Allergy to local anesthetic
Change in Mandibular Bone Width Using Two Stages Splitting Approach

Alveolar ridge splitting technique is a commonly used procedure for horizontal ridge augmentation of narrow ridges to allow placement of implants. However, the commonly used one-stage technique can cause malfracture and subsequent necrosis of the fractured part.

Twelve patients were selected randomly having posterior mandibular narrow edentulous ridge. The sample were selected to match a list of inclusion and exclusion criteria. In the first stage, all patients will underwent a mandibular ridge splitting technique using piezotomes. In the second stage, ridge expansion and implants were placed with only envelope flap. Assessment were included measurement of the buccal and lingual bone surrounding the implants and amount of increase in the bone width from the cone beam computed tomography.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-60 years old with no gender predilection.
* Patients presenting with posterior mandibular (premolar-molar area) narrow alveolar ridge
* that requires dental implantation.
* Minimum bone width of 3 mm
* Minimum bone height of 10 mm
* Proper inter-occlusal space

Exclusion Criteria:

* Uncontrolled diabetes.
* Heavy smokers.
* Current chemotherapy or radiotherapy.
* Alcohol or drug abuse.
* Pregnant women.
* Active infection.
* Inter-occlusal space not less than 7-8 mm.
* Parafunctional habits.
Prediction of Abdominal Aortic Aneurysm Shrinkage After Stent-placement With Artificial Intelligence

The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). The primary goal of this study is to build a prediction model for abdominal aortic aneurysm shrinkage one year after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Elective, initially technically successful (as described by the ESVS guidelines11), infrarenal EVAR for unruptured infrarenal AAA;
* Implanted endograft is a Gore Excluder, Medtronic Endurant, Cook Zenith, Cordis Incraft, Endologix AFX, Jotec E-Tegra, or Vascutek Anaconda endograft;
* Follow-up of the AAA of at least one year with imaging of the same modality as the preoperative imaging;
* Axial reconstructions of preoperative CT angiography available, preferably in the arterial phase and with 3 mm or smaller slice thickness.

Exclusion Criteria:

* Patients with ruptured or symptomatic AAA;
* Patients that were treated with fenestrated or branched endografts, iliac branched devices, non-CE marked devices within trial setting, other endografts (EVAS cases) or chimney procedures;
* Acute procedures;
* Reintervention before one year follow-up;
* Revision cases after previous open or endovascular aneurysm repair of an AAA;
The Effect of Ultrasonography-guided Fascial Plane Blocks in Breast Cancer Surgery Patients

The aim of this study was to evaluate the efficacy of serratus anterior plane (SAP) block, pectoserratus plane (PECS II) block, and erector spinae plane (ESP) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients.

Breast cancer is the most common type of cancer in women. Although surgical treatment is effective and curative, it is associated with many complications in the postoperative period. Acute pain after surgery is one of them. Approximately half of women undergoing breast surgery describe significant post-operative pain (\>5 on the Visual Analogue Scale; VAS) score that is not always effectively controlled by standard post-operative treatments. Poorly controlled postoperative pain has been associated with impaired functional recovery, delayed discharge from the post-anesthetic care unit, and prolonged hospital stay. In addition, poorly managed acute pain becomes chronic and is described as 'post-mastectomy pain syndrome'. Regional techniques can reduce acute and chronic postoperative pain. The development of ultrasonography (US)-guided regional anesthesia has led to the development of fascial plane blocks. Serratus anterior plan (SAP) block, pectoserratus plan (PECS II) block, and erector spina plan (ESP) block are frequently used for postoperative analgesia in patients undergoing breast surgery. he aim of this study was to evaluate the efficacy of serratus anterior plane (SAP) block, pectoserratus plane (PECS II) block, and erector spinae plane (ESP) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* elective breast surgery (modified radical mastectomy, breast conserving surgery, simple mastectomy, axillary lymph node dissection, etc.),
* 18 to 65 years old,
* American Society of Anaesthesiology (ASA) score I-III
* body mass index (BMI) \<32 kg/m2

Exclusion Criteria:

* contraindications to the block applications
* history of mental or neurological disorders
* history of chronic opioid use
* chronic alcoholism
* substance use
* treatment of chronic pain
* severe liver and kidney disease
* uncooperative patients
* patients scheduled for bilateral mastectomy
Protocol in Reeducation Occupational Therapist in Coronary Patients

The quality of life, linked to physical, social and mental performance in people with coronary heart disease represents the primary goals in terms of rehabilitation. This is often developed to meet the expected performance standard in order to give the person effective autonomy. However, is the occupational balance always evaluated? and this management adapted? Does occupational therapist, expert in autonomy and independence in multiple illnesses and disabilities, has a major role to play in cardiac rehabilitation? This area of expertise and the application of occupational therapy to coronary patients seems appropriate, if not necessary. However, there are few scientific studies on the need to include occupational therapy within cardiac rehabilitation protocols.

The occupational therapy goals are in line with the theoretical objectives of coronary rehabilitation. At present, there is a lack of data on the benefits of coronary occupational therapy rehabilitation.

Goals : Evaluation of the quality of life of coronary heart patients who have benefited from cardiac rehabilitation optimized by secondary occupational therapy sessions:

Evaluation of aerobic and anaerobic performance of coronary heart patients who have benefited from cardiac rehabilitation optimized by occupational therapy sessions.

Evaluation of aerobic and anaerobic performance of coronary heart patients who have benefited from cardiac rehabilitation optimized by occupational therapy sessions.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease
* Included in the cardiac rehabilitation protocol in Saint Etienne university hospital

Exclusion Criteria:

* Patients who not perform all sessions of the cardiac rehabilitation protocol
Experimentation With Screening for Bronchopulmonary Cancer and Primary Cardiovascular Prevention, Early Management of COPD and an Offer Exempted From Smoking Cessation

The study consists of recruiting a target population by sending a letter from the Regional Center for Cancer Screening in Ile de France.

In the screening program, a battery of examinations will be carried out at inclusion, one year, 2 years, 3 years, 4 years and 5 years.

The patients will be recruited by correspondence by by sending a letter from the Regional Center for Cancer Screening in Ile de France.

When the patient has agreed to participate, a screening program will be carried out The screening program includes performing a low-dose chest CT scan (STBD), spirometry, blood sampling (biobank + screening for cardiovascular risk factors) on inclusion, at 1 year and at 2 years. Subsequently, a telephone interview will be scheduled for 3 years to collect medical information, for a total follow-up period of 5 years. At each visit, a structured offer of smoking cessation will be proposed and a collection of the quality of life will be carried out. Each year, a telephone call from participants will be scheduled in order to maximize participation

Eligibility Criteria:
Inclusion Criteria:

* Women and men
* Age: 55 to 74 years old
* Smokers at more than 20 pack-years weaned for less than 15 years
* Affiliated to a social security organization

Exclusion Criteria:

* Presence of signs of PBC
* Subjects with a personal history of PBC of less than 5 years or under treatment
* Presence of serious comorbidities involving the vital prognosis at 6 months
* Subjects who have already benefited from a chest CT scan less than one year old.
* Refusal to participate in the study
* Absence of exposure to tobacco or insufficient exposure to tobacco or withdrawal \> 15 years
* Patient on long-term oxygen therapy
* Metal implants (thorax, spine) which can cause a deterioration in the quality of the image of the low dose scanner
* Subject included in another study protocol
Effect of Tadalafil Administration on Vasodilatation Mediated by Flow in Patients With Obesity Grade I-II

Obesity is a public health problem, not only for its high prevalence, but also because of the comorbidities found in it. Within the physiopathological mechanisms associated with obesity is a low-grade inflammatory state that is associated with endothelial dysfunction Endothelial dysfunction is known to be the beginning of the atherosclerotic process that eventually leads to the development of cardiovascular disease.

Erectile dysfunction is an example of endothelial dysfunction, where blood flow is compromised as a consequence of a reduction in the production of nitric oxide among others.

Tadalafil, which is an inhibitor of PDE-5, is currently used as a treatment for erectile dysfunction. However, it has been observed that the administration of tadalafil in patients with éndothelial dysfunction decreases arterial stiffness, having a positive effect on it, in addition it reduces the pulse pressure, systolic and diastolic pressure.

: The objective is to evaluate the effect of administration of tadalafil on vasodilatation mediated by flow in patients with obesity grade I-II and erectil dysfunction. A double-blind clinical trial with randomization and control group will be carried out. Male patients aged 25-60 years, BMI ≥30, without comorbidities will be included. They should not be under treatment with iPDE5 or statins, nor should they have uncontrolled ischemic heart disease. To carry out this test, two groups will be created: the first will receive a single dose of tadalafil 20 mg orally and the second will receive 20 mg of calcined magnesia (placebo),after a single administration, 24 hours later the investigators are going to evaluate vasodilatation mediated by. In addition, they will have a metabolic profile at the beginning.

For the analysis of results the statistical program SPSS version 21 for Windows will be used. The results will be expressed in averages and standard deviation and normality tests will be applied such as Kolmogorov Smirnof, Shapiro Wilk, as well as the Willcoxon and U Mann Whitney test.

Eligibility Criteria:
Inclusion Criteria:

* Male patients
* Age 25 to 60 years
* Obesity grade I-II
* .Sign the inform consent form.
* Answer the questionary IIFE

Exclusion Criteria:

. DM 1-2

* Systemic arterial hypertension
* Uncontrolled Mixed Dyslipidemia or under Hypolipemiant Treatment with statins.
* Active smoking
* Precedent of uncontrolled Ischemic cardiopathy.
* Use of anti-inflammatory drugs, including Acetylsalicylic acid, antihypertensive, antihyperglucemic, anti-anginal drugs, recent use of antiviral drugs that contains vasoconstrictors.
* Hepatic, renal, thyroid, and/or pulmonary decompensated disease.
* The precedent of hypersensibility to the phosphodiesterase-5 inhibitors.
* Patients that are under treatmen with iPDE