cyrilzakka/clinical-trials huggingface dataset:
Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery.

Deep sternal wound infection after coronary artery bypass graft is a very dangerous complication as it prolongs hospital stay, increase morbidity and mortality, and increase cost of care.

As a risk factor of surgical site infection, risk index reported by NNIS (national nosocomial infection surveillance), Euroscore, or Society of thoracic surgeon risk score are currently used. However, as various performances are reported regarding these index or scoring systems, and many factors are needed for these index or scoring system, there is a need to develop a more simple risk factor with better performance. We focused on the differential blood cell count, as the neutrophil and lymphocyte count are related to the degree of surgical invasion, and inflammatory response. Previous studies reported that the neutrophilia or lymphopenia is related to postoperative infection. Therefore, we are trying to evaluate the performance of preoperative or postoperative the blood cell differential count as a risk factor for sternal wound infection after coronary artery bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.

Exclusion Criteria:

* Those underwent coronary artery bypass graft surgery with mini-thoracotomy
* Those with insufficient study data recognized by electronic medical record
Multifunctional Cataract Surgery Assistive Instruments Used in Cataract Surgery

In order to better cope with complex situations of cataract surgery, we designed and improved a new set of multi-functional cataract surgery auxiliary devices, including ophthalmic surgery auxiliary hooks, eye retractor hooks and membranous cataract scissors. Their common feature is that they have the function of 2-3 traditional surgical instruments, which can be switched in operations, reducing the replacement of different surgical instruments, lowing the number of surgical instruments in and out of the incision, reducing trauma and improving surgical efficiency. The purpose of this multi-center prospective clinical study is to verify the advantages of this new group of multifunctional devices and further summarize the experience and improvement by comparing the safety and effectiveness of traditional cataract surgical instruments combined with new multifunctional cataract assisted surgical instruments and traditional cataract surgical instruments alone.

Cataract is the number one cause of blindness, and the main treatment method is surgery to remove the cloudy lens and install an intraocular lens. The operation relies on ophthalmic micromanipulative instruments, but in complex cases such as abnormal lens capsule, ocular trauma, etc., the difficulty of surgery increases, so that conventional instruments are often unable to complete the operation well. In order to better cope with these complex situations, we designed and improved a new set of multi-functional cataract surgery auxiliary devices, including ophthalmic surgery auxiliary hooks, eye retractor hooks and membranous cataract scissors, which have obtained utility model patents and first-class medical device filings. Their common feature is that they have the function of 2-3 traditional surgical instruments, which can be switched intraoperatively, reduce the replacement of different surgical instruments, reduce the number of surgical instruments in and out of the incision, reduce trauma and improve surgical efficiency. The purpose of this multi-center prospective clinical study is to verify the advantages of this new group of multifunctional devices and further summarize the experience and improvement by comparing the safety and effectiveness of traditional cataract surgical instruments combined with new multifunctional cataract assisted surgical instruments and traditional cataract surgical instruments alone.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of cataract Patients need to undergo cataract surgery

Exclusion Criteria:

- Active intraocular inflammation The intraocular pressure (IOP) was higher than 25 mmHg The endothelial cell count (ECC) was less than 1,200 cells/mm2 Combined with other eye diseases Combined with other serious systemic diseases
Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy

Minimal hepatic encephalopathy represents a common complication present in well-compensated cirrhotic patients that impairs patients daily functioning and health-related quality of life. Acetyl-L-carnitine has been shown to be useful in improving blood ammonia and cognitive functions in cirrhotic patients with minimal hepatic encephalopathy. This study evaluated the effects of acetyl-L-carnitine treatment on health related quality of life and on depression in patients with minimal hepatic encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed as having cirrhosis at the outpatient Internal Medicine of the Department of Senescence of Cannizzaro Hospital (Catania) were candidates for enrolment. The diagnosis of cirrhosis was based on clinical, biochemical and ultrasonographic or liver histological data.

Exclusion Criteria:

* Exclusion criteria were overt hepatic encephalopathy or a history of overt HE; history of recent alcohol intake; infection; recent antibiotic use or gastrointestinal bleeding; history of recent use of drugs affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs; a history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; electrolyte imbalance; renal impairment; hepatocellular carcinoma; severe medical problems such as congestive heart failure, pulmonary disease or neurological or psychiatric disorder that could influence quality of life measurement; inability to perform neuropsycological tests.
Effects of Anesthetic Techniques on Renal Function

This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children.

Acute kidney injury is one of the major complications after heart surgery, which increases the mortality of patients. Therefore, early prevention and detection of acute kidney injury is particularly important. In recent years, more and more studies have shown that both sevoflurane, an inhaled anesthetic widely used in clinical practice, and propofol, an intravenous anesthetic, have protective effects on kidneys. The aim of this study was to investigate the perioperative effects of two different anesthetic techniques on renal function for pediatric cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* children with congenital heart disease
* \<3 years of age

Exclusion Criteria:

* preoperative renal insufficiency;
* renal malformation, kidney absence
Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension

The purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po) before surgery will help prevent the development of tourniquet pain and hypertension while the tourniquet is inflated during orif of tibia fracture.


Eligibility Criteria:
Inclusion Criteria:

* Patient ages 18-64
* ASA physical status 1-3
* Schedule for orif tibia fracture with use of pneumatic tourniquet

Exclusion Criteria:

* Allergy to study medications
* polytrauma
* lower extremity crush injury
* chronic opioid use
* sickle cell disease or trait
* peripheral vascular disease
* poorly controlled hypertension
* history of DVT/PE
* morbid obesity (BMI \> 35)
* patient or surgeon refusal
* patient inability to properly describe postoperative pain to investigators
Protective Immunity Project 02

Influenza (Flu) vaccine is recommended for kidney transplant patients who are at least 6 months post-transplant. The influenza vaccine stimulates the immune system to builds protective antibodies against the flu virus.

Previous research has shown that adult kidney transplant patients are not able to form as much of these protective antibodies as compared to healthy volunteers. Research has also suggested that different immunosuppressive medicines may have different effects on antibody formation. In this study, we hope to evaluate these differences in more detail.

In recent years, increasingly effective, but also increasingly complex, immunosuppressive regimens have been developed, however, there has been little detailed systematic study of the immune changes that occur in response to vaccination with these newer immunosuppressive regimens.Current policies on vaccination of transplant recipients are generic and continue to be based on old concepts rather than on any new understanding of the effects of these newer therapies on the immune system.

We hope to improve our understanding of the effects of the immunosuppressive regimens in use today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) on immune response to flu vaccine. Such knowledge will be critical to helping clinicians develop strategies for getting desirable immune responses while not causing rejection.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between 18 and 59 years of age
2. Greater than six months post deceased or living donor renal transplant
3. Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
4. Patients with no known contraindications to flu vaccine (e.g. egg allergy, prior serious adverse reaction to flu vaccine, current febrile illness, marked leukopenia (WBC \< 2500 cells/ml)
5. Women of childbearing potential must have a negative serum pregnancy test within 7 days of study enrollment and must not be breast-feeding.

Exclusion Criteria:

1. Patients with evidence of an active systemic infection
Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade

Assessement of a new approach of an ultrasound guided brachial plexus blockade between the infraclavicular and axillary area.

After an assessement of this new approach of ultrasounded-guided brachial plexus blockade in cadavers, the aim of this human study was to asssess the validity of this method in humans. The probe will be disposed on the shoulder, and the brachial plexus will be seeked below the deltoid, lateral to the major pectoralis muscle and in the vicinity of the brachial artery. At this area, an ultrasounded guided needle was inserted with an in-plane direction towards the brachial artery and local anesthetics was disposed all around the artery, without puncturing the differents nerves. Regional blockade will be evaluated by measuring onset and duation time for sensitive and motor blockade, effectiveness of this blockade, patient's confort during the procedure, ease of the procedure for practitionner, quality of ultrasound image's interpretation before and after injection.

Eligibility Criteria:
Inclusion Criteria:

* Arm surgery performed under axillary blockade

Exclusion Criteria:

* Local anesthetics allergy
* Coagulation disorder
* History of chronic pain
* Drug or alcohol abuse
The HF-POL Study - Multicenter Study of Polish Patients With HF and LVEF >40%

HF-POL is the first Polish multicenter observational prospective registry of patients with heart failure and ejection fraction more than 40% designed by Heart Failure Association of the Polish Cardiac Society. The purpose of this study was to provide first characteristics of Polish population patients with heart failure and EF\>40% and to provide a better understanding of medical practice, based on observational data, including diagnosis, treatment, and prognosis over 3-year follow-up.

HF-POL is the first Polish multicenter observational prospective registry of patients with heart failure and ejection fraction more than 40%. HF-POL study is conducted by the Heart Failure Association of the Polish Cardiac Society in cooperation with the Committee for Clinical Initiatives of the Executive Board as part of the Scientific Platform initiative. The leading center of the study is the Military Medical Academy Memorial Teaching Hospital of the Medical University of Lodz, Poland. The Primary Investigator is Malgorzata Lelonek; the Steering Committee includes Malgorzata Lelonek, Mariusz Gasior, and Marcin Grabowski. The study was approved by the Bioethics Committee at the Medical University of Lodz (No. RNN/240/21/KE; October 21, 2021).

The purpose of this study was to provide first characteristics of Polish population patients with heart failure and EF\>40% and to provide a better understanding of medical practice, based on observational data, including diagnosis, treatment, and prognosis over 3-year follow-up. Patients have been recruited at each participating center since that center's activation on the eCRF.biz platform (a clinical data management system, https://rejestr.gbbsoft.pl/hf-pol). We collected data included demographics, medical history, concomitant medications, selected laboratory, electrocardiographic and echocardiographic results as well ascomorbidities. Patients are diagnosed and treated according to the current clinical practice guidelines and the standard of care at participating centers.

All consecutive patients meeting the inclusion and exclusion criteria are being enrolled.

Heart Failure should be recognized according to the 2021 ESC guidelines. The study allows recruitment based on results from medical records, especially for outpatients with a history of Heart Failure. The study population includes patients with Heart Failure and LVEF \>40%. In total, a minimum of 1000 patients from 14 Polish centers will be enrolled.

Patients will stay in 3-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* documented EF \>40%
* symptomatic chronic Heart Failure or acute Heart Failure (worsening of chronic Heart Failure or Heart Failure de novo) requiring hospitalization and intravenous agents

Exclusion Criteria:

* age \<18 years
* dyspnea due to other causes than Heart Failure.
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients

In this study, the investigators would like to assess how intravesical BCG schedules after immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell responses both systemically and locally in the bladder.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient with histological confirmation of NMIBC
* Full recovery from surgery (TUR) from 1 to 6 weeks
* Karnofsky performance status of 60% or more
* Laboratory parameters for vital functions should be in the normal range
* Women of childbearing potential must use adequate contraception and have negative pregnancy test before and during the whole period of study treatment administration
* Male patients should avoid behaviors leading to child conception up to 2 months after administration of study treatment

Exclusion Criteria:

* Muscle invasive bladder cancer
* Metastatic disease to the central nervous system, for which other therapeutic options, including radiotherapy, may be available
* Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
* Any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases(Patients with vitiligo are not excluded to participate in the trial)
* History of severe allergic reactions to vaccines or unknown allergens
* Patients require concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.

The use of prednisone, or equivalent, \<0.125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted

* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent
* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
* Lack of availability for immunological and clinical follow-up assessment
* For female patients of childbearing potential: positive urine or serum pregnancy test or lactating
* Known positive HIV test, HBV, HCV.
Study to Assess the Effect on Recovery of GI Motility and Safety and to Determine the Optimal Dose of LD02GIFRO

This clinical trial is conducted to determine the optimal dose of LD02GIFRO in improvement of gastrointestinal motility between each dose group by comparing the effectiveness and safety in patients undergoing colon resection.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 20 years
* Subject is scheduled for a partial colon resection with primary anastomosis via laparotomy
* Subject is scheduled to receive primary postoperative pain management with intravenous patient-controlled analgesia (PCA) opioids

Exclusion Criteria:

* Subject is scheduled for a total colectomy, colostomy, ileostomy
* Subject has complete bowel obstruction
* Subject is scheduled for laparoscopic surgery
Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)

To learn if new HPV tests can provide the same results as standard HPV tests. The findings from this study may aid in the development of new HPV tests that require less equipment and are more accessible.

Primary Objectives

1. To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").

Secondary Objectives

1. To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia (CIN 2+).
2. To assess how different sample processing methods affect the performance of the Rice HPV test.
3. To assess how different test readout methods affect the performance of the Rice HPV test.

Exploratory Objectives

1. Compare the performance of the Rice HPV test between provider-collected and self-collected samples.
2. Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling.
3. Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert.

Eligibility Criteria:
Inclusion Criteria:

1. People with a cervix 21 years of age or older.
2. Scheduled to undergo hrHPV testing at MD Anderson and The Harris Health System (LBJ Hospital) according to national and institutional guidelines at time of enrollment OR are anticipated to undergo a LEEP, ECC, or biopsy.
3. Willing and able to provide informed consent.
4. Able to perform protocol-required activities. Able to speak and read English or Spanish.

Exclusion Criteria

1. Patient or provider decision not to perform HPV testing. This does not apply to patients that are undergoing either a LEEP, ECC or biopsy.
2. Participant or provider decision not to collect a sample for this study.
3. Participants that are pregnant.
Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People

This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people.

This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people: a randomized, double-blind, placebo-controlled, and parallel clinical investigation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are easy to feel fatigued
* Subjects have poor sleep quality

Exclusion Criteria:

* Pregnant women or preparing for pregnancy.
* Lactating women.
* Women gave birth 6 months before the study.
* Poor kindy and livers funcitons
* Severe cardiovascular or other chronic diseases
* Alcohol abuser
* Using immune-associated supplements
Indications and Interest of US-guided Synovial Biopsies Performed in Clinical Practice

Synovial biopsies are now routinely performed both in research and in clinical practice. The developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated their use and tolerance by the patients. However, their interest in clinical practice in the context of an undifferentiated arthritis remains debated.

In this study, the investigators will collect all the synovial biopsies performed in clinical practice in 18 Rheumatology Unit throughout France. All the participants received a standardized training on US-guided synovial biopsies. For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form. The investigator will determine the number of cases where the synovial biopsy allows drawing a definite diagnosis.

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing an US-guided synovial biopsy in clinical practice in the context of an arthritis of unknown origin

Exclusion Criteria:
Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.