cyrilzakka/clinical-trials huggingface dataset:
Patient Blood Management in Cardiac Surgery

Preoperative anemia is associated with an important increase in transfusions of red blood cells (RBC) compared to a non-anemic patient in cardiac and non cardiac surgery. Furthermore transfusion is also an independent factor of morbi-mortality with notably an increase in the infectious risk, immunological, an increase of the risk of cardiac decompensation, respiratory decompensation Transfusion Related Acute Lung Injury (TRALI) or Transfusion Associated Cardiac Overload (TACO), and an increase in mortality of 16%.

Management of perioperative transfusion is therefore a public health issue. Since 2010, the World Health Organization (WHO) has been promoting a systematic approach to implement blood management programs for the patient to optimize the use of resources and promote quality and safety of care.

Improving the relevance of transfusion in cardiac surgery could be achieved by optimizing the management of patients around 2 axis:

A:non-drug intervention : Review of Practices to Improve the Management of Perioperative RBC Transfusion

B:drug intervention : Systematic correction of pre- and postoperative iron, vitamin deficiencies and anemia

The aim of this program is to improve the relevance of transfusion in cardiac surgery and to limit the morbidity and mortality induced by transfusion. This program is part of a global project of pre, per and postoperative management of the patient undergoing cardiac surgery programmed under extracorporeal circulation (ECC). It requires a multidisciplinary approach between cardiologists, anesthesiologists and intensivists, perfusionists, cardiac surgeons and paramedical teams to optimize the management of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for cardiac surgery under ECC
* Patient affiliated or beneficiary of a social security scheme
* Patient having given his consent

Exclusion Criteria:

* Urgent surgery (less than 48h)
* Contraindication to iron injection : proven allergic reaction
* Erythropoietin allergy
* Protected patients: Majors under some form of guardianship or other legal protection; pregnant, breastfeeding or parturient woman.
Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors

This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate that those 2 formulations are considered to be the same for all intents and purposes by making sure they are acting on the body with the same strength and are absorbed in similar amounts by the body. During the bioequivalence phase, patients will take orally at a daily dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days on/2days off dosing schedule, after which time, patients will switch to the alternate formulation for one additional week. After the bioequivalence phase, all patients may continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a histopathologically or cytopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer, who have progressed despite standard therapy, or for which no standard therapy exists
2. ECOG performance status (PS) 0, 1 or 2
3. Patients must meet protocol-specified laboratory values

Exclusion Criteria:

1. Patients with brain metastases
2. Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
3. Patients who have not recovered from previous anti-cancer therapies
4. Patients who are expected to receive any prohibited medications during the bioequivalence phase of the study
5. Female patients who are pregnant, breast feeding
6. Fertile male or women of child-bearing potential not willing to use two highly effective methods of contraception

Other protocol-defined inclusion/exclusion criteria may apply
Quinoa Effects on Glycemic Index and Satiety

The purpose of this study is to to assess the glycemic index and the satiating properties of different Quinoa varieties, using a Visual Analogue Scale in a sample of healthy overweight subjects.

Pilot study to evaluate the glycemic index, and the satiating effect using different Quinoa varieties in a group of healthy overweight subjects.

Eligibility Criteria:
Inclusion Criteria:

* Men and women from 18 to 65 years old.
* Body mass index (BMI) ≥25 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent

Exclusion Criteria:

* Individuals with BMI ≥30 or \<25 kg/m2
* Vegetarians or individuals with a fiber intake ≥30 g/day
* Individuals diagnosed with Diabetes Mellitus
* Individuals with dyslipidemia on pharmacological treatment
* Individuals with hypertension on pharmacological treatment
* Smokers or heavy drinking individuals (\>2-3 servings/day in men and \> 1 serving/day in women (1 serving=1 glass of wine or 1 bottle of beer))
* Individuals with large weight fluctuations or who have undergone in recent months a weight loss diet
* Individuals with gastrointestinal diseases that affect the digestion or the absorption of nutrients
* Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, oral antidiabetic medications)
* Pregnant or breastfeeding women
* Women with menstrual irregularities (absence of menstrual cycle at least 2 months prior)
* Individuals with intense physical activity
Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study

The purpose of the study is to compare the accuracy of the diagnosis of endoleak in patient with EVAR comparing Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based iterative reconstruction (MBIR- VEO TM).

Background:

The aortic aneurysm is a common and serious disease share its complications (rupture ) , often fatal. It is recognized that pass a certain diameter surgical or endovascular treatment reduces mortality by avoiding treatment in extreme provider of high morbidity and mortality emergency. Endovascular anevrysm repair (EVAR) treatment has proven effective but unfortunately this treatment presents complications ( endoleak ) should be sought systematically by repeated checks CT . The irradiation in these patients is a major problem with repeated exposure radiation. The follow up of these patients requires repeated CT because endoleaks can be delayed.

Iterative reconstruction of previous generation have reduced the dose , we dispose the last Model-based iterative reconstruction (" VEO " ) for a further reduction of patient dose . This technique has not yet been evaluated in the detection of endoleaks.

The purpose of the study is to compare conventional CTA (ASIR50) ( gold standard now) with Model-based iterative reconstruction (MBIR- VEO TM) in the detection ( and classification ) of endoleaks in patients traited by EVAR.

All patient admited in Radiology to follow up his EVAR is included in the study and receive both CT: Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based iterative reconstruction (MBIR- VEO TM) and the result of thoses 2 CT are compared by 2 readers (blinded of the result) The BMI , other complications, the DLP , dose reduction and quality of the examination is noted .

Eligibility Criteria:
Inclusion Criteria:

* informed and a written consent
* all patients consulting to follow up his EVAR
* 18-90 years
* French

Exclusion Criteria:

* pregnant
* juvenile patients
* patient who refusal the study
* CI of contrast iodine injection : CI of ultravist
* llergy
* renal failure creatinemy \<30 ml/min
Establishment of Retrospective and Prospective Multicenter Cohort for Chronic Hepatitis B

According to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide. Subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in Korea.

The natural history of chronic liver disease differs greatly according to race and ethnicity. However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients. Therefore, the investigators plan to establish a retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients that may be utilized for various future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for Korean patients with chronic hepatitis B, as part of a nationwide project supported by the Centers for Disease Control (CDC), Korea.

The investigators plan to collect 500 cases as have been advised by the CDC during the study period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past 5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver fibroscan and liver biopsy from these 4 institutions. The investigators plan to register available cases retrospectively from those who are available to agree to give written informed consent to participate in this study, and to register the remaining numbers of cases prospectively, according to the inclusion and exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

1. Subject aged 20 years or older
2. Subject who has been diagnosed with chronic hepatitis B (HBs Ag (+) for minimum of 6 months_
3. Subject who is currently under clinical follow up at the registered institution
4. Subject who has undergone or who can undergo liver fibroscan at the time of registration
5. Subject who has given informed consent to the enrollment

Exclusion Criteria:

1. Subject with decompensated liver cirrhosis or hepatocellular carcinoma at the time of initial liver fibroscan
2. Subject who had previously undergone antiviral therapy for chronic hepatitis B
3. Subject who are concomittantly infected with HCV, HDV or HIV
4. Subject with chronic alcoholism defined as equal to or greater than 40g of alcohol for duration of 5 years or longer
5. Subject who has been diagnosed with right sided heart failure
6. Subjects whose liver fibroscan result is not valid
7. Subject who is considered ineligible to the enrollment to clinical study by the researcher
8. Subjects who is pregnant at the time of registration
9. Pregnancy
Effect of A-PRF After Removal of Wisdom Teeth

To evaluate the healing effect of advanced platelet-rich fibrin (blood clot charged with growth factors) taken from the patient own blood on the extraction site.

This is a randomized double-blind clinical study. A preoperative and radiographic evaluation will be done in order to select the patients.

Inclusion criteria are healthy patients above 18 years old with vertical or mesioangular bilateral impacted mandibular third molars. Exclusion criteria are missing second molars or indicated for extraction (un-restorable and remaining roots), patients under immunosuppressant and patients with acute infection. Those who fail to attend for follow-up appointments will be excluded.

The probing depth (PD) and clinical attachment level (CAL) distal to the second molar will be measured before each procedure. All patients will undergo bilateral removal of 3rd molar in a single appointment. Envelope flap with distal extension and a full-thickness mucoperiosteal flap will be utilized and the teeth will be removed with elevators. Bone removal will be utilized if needed.

Following the extraction, venous blood will be withdrawn to fill 2 tubes of 10mL each (sterile vacuum plain tube for A-PRF™ +). The blood tubes will be spun in the centrifugation machine for 13 minutes at 1300 rpm then it is pressed in PRF Box to form PRF clots which will be placed in one the extraction socket while the other socket will not receive a PRF (control).Randomization will be done using a coin toss.

Both extraction cavities will be closed using 3-4 interrupted sutures using 3.0 chromic gut sutures.

Postoperatively, all patients will be treated with oral antibiotic amoxicillin 500 mg and non-steroidal anti-inflammatory medications ibuprofen 600mg in case. also, all patients will be instructed to rinse with 0.2 % Chlorhexidine mouthwash for seven days postoperative.

On the 7th,15th and 90th days, patients will be asked about pain using visual analog scale (VAS) and whether they have any concern related to extraction socket statuses like halitosis, empty socket, open socket, dehiscence, and infection signs including swelling, pus, or fever.

They will also undergo a clinical examination at this visit and the consecutive visits. The following measures will be assessed during each clinical examination: the presence of a pocket distal to the adjacent second molar measuring the pocket depth and clinical attachment level and any signs of infection.

Data will be analyzed using statistical software. Analysis of multivariate regression will be used. The healing status will be compared between the graft site and the control site. Results will be interpreted to be statistically significant if they have a P-value of less than 0.05

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients above 18 years old with mirror image vertical or mesioangular bilateral impacted mandibular third molars

Exclusion Criteria:

* Missing second molars or indicated for extraction (un-restorable and remaining roots).
* Patients under immunosuppressant and patients with acute infection.
* Patients who fail to attend for follow-up appointments.
Laparoscopic Kasai Has Similar Anesthetic Outcomes to Open Kasai

Biliary atresia (BA) is a rare biliary tree disease with a high incidence in eastern Asia. Kasai operation is a standard treatment for BA, and studies have shown that timely Kasai operation is crucial for better outcomes. The Kasai operation can be performed as either an open or laparoscopic technique. This study aimed to compare the differences in anesthetic management between the two surgical groups. Herein, we compared the outcomes of infants with BA who underwent the open and laparoscopic Kasai surgery.

Biliary atresia is (BA) a rare biliary tree disease. This disease, which is usually found in infancy is characterized by biliary inflammation and obliteration. The incidence variate from 1 in 5000 to 20000. However, high prevalence rate up to 1 in 5-10,000 was comparatively noted in eastern Asia, especially in Japan and Taiwan. Biliary atresia can be treated by "Kasai operation" ( Kasai portoenterotomy) or liver transplantation. In the previous study, 60% of biliary atresia patients after receiving Kasai portoenterostomy could have better liver prognosis.The timing of Kasai operation is also crucial, increased age of surgery had negative influence in the long-term follow up.

Traditionally, Kasai portoenterostomy was performed by open surgery. As the progression and popularity of minimally invasive surgery, laparoscopic Kasai was first introduced in 2002 and then performed in many countries. However, the advantage of laparoscopic Kasai seems still controversial due to many indicative outcomes as early jaundice clearance, native liver survival (NLS) and liver transplantation rate within 1 year after the Kasai operation even adhesions prevention seems no better maybe worse in laparoscopic group.But in our hospital, no statistically significant differences were observed for hospital stay and outcomes (including early jaundice clearance rate, episodes of cholangitis, and 2-year native liver survival rate) between the open and the laparoscopic Kasai operations.Even the better operation view was noted in laparoscopic group but operation time seems almost all prolonged in laparoscopic one compared to open one, that makes excessive fluid infusion and hypothermia easily found in laparoscopic group . However, no hypothermia and laryngeal edema were noted in our hospital compare to previous study

Eligibility Criteria:
Inclusion Criteria:

* children who had undergone Kasai portoenterostomy between January 2011 and December 2021

Exclusion Criteria:

* severe congenital heart disease requiring surgical treatment,
* reoperation,
* a diagnosis of non-biliary atresia,
* incomplete medical records.
The New Serial Treatment of Temporomandibular Disorders

The purpose of this study is to look at temporomandibular joint (TMJ) pressure as a guideline to analyze the different treatments for temporomandibular disorder (TMD), and judge the feasibility of the adjust TMJ pressure treatment and to reach a conclusion on the different treatments for different types of TMD, and determine the new serial treatment of temporomandibular disorders.

Temporomandibular Disorder is a common disease nowadays, but there is no guideline for the treatment of TMD. TMD can be divided into masticating muscles dysfunction; internal derangement; inflammation; osteoarthrosis, this study will classify the internal derangement, inflammation and osteoarthrosis into three types according to the TMJ pressure. Then the patient will receive the adjust pressure treatment according to their TMJ pressure. The first part of the TMD patients will receive psychogenic treatment, medicine, physical treatment, bite plate, occlusion treatment, rebuilding occlusion treatment, orthodontic treatment, et. If the patients do not have a good curative effect, part of them will change the treatment into arthrocentesis, arthroscopic treatment or operation treatment, the other part of patients, according to their TMJ pressure, receiving the associated adjust pressure treatment or adjust pressure treatment only. This study will call on the patients for three years and collect the clinical information, then doing the medical statistics.

Eligibility Criteria:
Inclusion Criteria:

* Limited Month Opening
* Abnormal of the Month Opening Type
* Paint During the Month Open or Close
* Condylar Position Paint
* Clicking of the Temporomandibular Joint
* Enlargement of the Upper Temporomandibular Joint Gap
* Dislocation of the Temporomandibular Disc
* Bone of the Temporomandibular Joint Changement
* Patient in the Age of 16-60
* Voluntary Patient

Exclusion Criteria:

* Dysimmunity Disease
* Dysfunction of Heart Liver and Kidney Disease
* Patient can not do the Guide Line
* Life-threatening Patient
* Serious Limited Mouth Opening
* Epilepsy
* Tetanus
* Pregnancy or Women in the Pregnancy Period
* Supportive Temporomandibular Disease
Comparison of the Efficacy of I-Prf Impregnated Collagen and L-Prf on Healing After Impacted Third Molar Surgery

Impacted third molar extraction is a very common surgical intervention. Post-procedure pain causes various post-operative changes such as edema and trismus. Minimizing these changes will enable patients to overcome the post-operative process more easily. In this study, it was aimed to compare the possible effects of I-PRF (Impregnated Platelet Rich Fibrin) type 1 collagen with L-PRF (Leukocyte Platelet Rich Fibrin) on postoperative complications and wound healing after lower impacted wisdom tooth surgery. There are studies in the literature showing that very different treatment methods are used for buried twenty-year-old surgery. However, although there are studies in which intra-socket L-PRF, I-PRF, and collagen plugs are applied, there is no accepted standard for comparing the effects of L-PRF and I-PRF impregnated type-1 collagen with each other or for postoperative comfort. The aim of the study is to observe the effect of 2 different techniques on postoperative complications and possible changes in wound healing and discuss whether there is a difference and the effective one.

Fifty patients were included for the randomized, prospective, split mouth and single-blind study. Two groups were formed in the study. The lower right and lower left wisdom teeth of the patients with extraction indication for lower impacted wisdom teeth were included in separate groups. In the first group (on one side of the same patients), leukocyte platelet-rich fibrin (L-PRF, 2700rpm,12 min) was obtained after lower impacted wisdom tooth surgery, applied into the socket and sutured. The other tooth of the patient was operated 5 weeks after the operation of the region included in the first group. In the second group (to the other side of the same patient), injectable platelet-rich fibrin (I-PRF, 700rpm, 3min) was obtained and 1\*2 cm type 1 collagen plug (ACE RCP(Resorbable Collagen Plug), Resorbable Collagen Plug, Collagen Matrix, Inc. Oakland, New Jersey, USA) was impregnated and applied into the socket as such. It was followed for 4 weeks. Both surgical sites were sutured with 4\\0 silk sutures (18mm, 3\\8 sharp, 75cm black suture). It was determined randomly which material would be used first on which side.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years and over,
* Patients with semi-impacted or fully impacted wisdom teeth,
* Patients without systemic disease (According to ASA(The American Society of Anesthesiologists) classification, ASA1 individuals),
* Individuals who did not use any medication in the last two weeks.

Exclusion Criteria:

* Individuals with painful temporomandibular joint disease,
* Internal irregularity and/or inflammatory joint disease with a mouth opening of less than 25 mm,
* Pregnant and lactating individuals,
* Individuals who do not come to their postoperative controls,
* Individuals using different drugs other than those recommended,
* Individuals who are allergic to the study drugs and materials.
Clinical Retention of Glass Ionomer Sealants Placed With and Without Rubber Dam: a Comparative Analysis

A comparative analysis of glass ionomer sealant placed on permanent molars with and without a rubber dam to assess the retention over a 2 year period.

The purpose of the study is to compare the retention rates of glass ionomer sealants placed on first permanent molars over a period of 2 years. Pediatric patients (under \<10 years of age) will receive a glass ionomer sealant on all four permanent first molars. One side will be randomly selected with rubber dam isolation and the contralateral side will have no rubber dam isolation for the placement of the sealant. Over a 2 year period, every 6 months the sealants will be assessed for retention.

The glass ionomer sealant material will be Fuji Triage (GC America). The following dental materials that will be used are cotton rolls, non-latex rubber dam, topical benzocaine, dental mirror, glass ionomer dispensing gun, dental explorer, triturator for the glass ionomer, cotton gauze, suction tip, air-water syringe.

Eligibility Criteria:
Inclusion Criteria: healthy children who need sealants on 4 permanent molars that are not hypo plastic, are caries-free, and with no enamel defects.

-

Exclusion Criteria: hypoplastic molars, caries, teeth with existing restorations, and those with enamel defects,

-