cyrilzakka/clinical-trials huggingface dataset:
Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

Double-blind placebo-controlled randomized trial aiming to assess the role of Vitamin C supplementation in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.

Women undergoing Elective GYN surgery are a particularly high-risk group for UTIs, because these operations involve surgery adjacent to the bladder and delayed bladder emptying is common. It has been estimated that the 'risk of Urinary tract infections among women undergoing elective Gynecologic GYN surgery is between 10-64%, following catheter removal. Catheterization, in itself, poses a significant risk for UTIs because insertion and removal introduce bacteria and cause trauma, both of which may increase the risk of UTIs. The incidence of UTI for women in the general population is estimated to be 3-4% per year vs 5% per day of catheterization. For this reason, multiple interventions have been studied for the prevention of UTIs. Ascorbic acid (vitamin C) is often suggested as a supplement that can prevent recurrent UTIs by acidification of the urine. Strong clinical evidence to support this claim in healthy adult women is lacking. Because of the lack of literature regarding the use of Vitamin C as a prophylactic agent for the prevention of UTIs, the investigators wish to conduct this study to assess the potential therapeutic efficacy of Ascorbic acid in preventing UTIs after elective GYN surgery.

Eligibility Criteria:
Inclusion Criteria:

* Nonpregnant women
* 18 years of age or older
* Undergoing elective GYN surgery

Exclusion Criteria:

* Pregnant women
* Already taking Vitamin C supplementation
* Nephrolithiasis
* Congenital anomaly or neurogenic bladder
* Allergy to ascorbic acid
* On therapeutic anticoagulant medicine during the 6 weeks after surgery
* Gynecological surgery involving fistula repair or a vaginal mesh removal
* Positive Urinalysis in the pre-admission unit
* Recurrent UTIs
* Diabetes
* G6PD
* Hemochromatosis
* Renal disorders
The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy

It is a prospective, non-randomized, single-arm cohort study. A total of 10 patients will be included in this study. Based on standardized treatment, the treatment of bioartificial liver device will be applied 48-72 hours after extensive hepatectomy. In order to evaluate the security and effectiveness of the device, liver function, liver volume, the incidence of liver failure and other results will be analyzed.

Include large-scale hepatectomy patients who meet the Inclusion criteria into the experimental group. Patient will be sent to ICU monitoring after surgery , the investigators will evaluate the blood routine, liver and kidney function, blood coagulation function, and immune inflammation indicators on the first day after surgery, and large veins will be temporarily indwelled within 48-72 hours Hemodialysis tube, then take artificial liver treatment which lasts 4-6h, follow-up test results on the 1st day, 3rd day, 7th day, 1 month and 3 months about blood routine, liver and kidney function, coagulation function, blood ammonia, Immune inflammation indicators, imaging examinations (CT or MR) at 7 days, 1 month and 3 months after treatment, to evaluate the recovery of liver function and liver regeneration after artificial liver treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as liver cancer, hepatolithiasis, benign liver tumor, with clear indications for liver resection;
2. Liver function Child A-B;
3. There is no contraindication to surgery for cardiopulmonary function;
4. The expected remaining liver volume/standard liver volume is less than 50%;

Exclusion Criteria:

1. In the late stage of the disease, patients with frequent symptoms such as cerebral edema accompanied by cerebral herniation and clinical evidence indicating intracranial hemorrhage;
2. PaO2/FiO2 is less than 200 and cannot be corrected;
3. Patients with diffuse intravascular coagulation;
4. Those with active bleeding;
5. Uncontrolled infection;
6. The platelet count is less than 50,000/μL and cannot be corrected;
7. There is no blood vessel available for dialysis treatment;
8. HIV, HDV or HCV positive;
9. Drug abuse within 1 year;
10. Those with severe systemic circulatory failure;
11. Those who are highly allergic to the drugs used in the treatment process, such as plasma, heparin, protamine, etc.;
12. Combined pregnancy;
13. Patients with hepatorenal syndrome;
14. Patients with autoimmune liver disease;
15. Patients with non-alcoholic fatty liver and hereditary liver diseases (Wilson syndrome and a-antitrypsin deficiency);
16. Other conditions that the clinician believes cannot tolerate the treatment.
A Clinical Trial to Evaluate the Safety and Efficacy of Single-use Fibrous Ring Sutures for the Suture of Fibrous Ring Incision After Nucleus Pulposus Removal

The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. The success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, VAS pain score (low back, bilateral lower extremities), Oswestry index (ODI index), and Short were evaluated The effectiveness evaluation results of Form-12 health survey (SF-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, gender unlimited;
2. Meet the diagnosis of lumbar disc herniation (refer to the Guidelines for Diagnosis and Treatment of Lumbar disc herniation), and expect to undergo single-level disc nucleus pulposus extraction;
3. The history of lumbar disc herniation is more than 6 weeks, and systematic conservative treatment is ineffective；
4. ODI index ≥20 points;
5. In the VAS score of bilateral lower limbs, at least one side was ≥4 points;
6. The score of the three evaluation indicators according to the modified Pfirrmann grade, age and disc height is no more than 7 points (see Annex 1 for the criteria);
7. Voluntarily participate and sign informed consent;
8. Be able to communicate well with research doctors, have good compliance, and can follow the requirements of clinical research.

Exclusion Criteria:

1. Laboratory examination (blood routine examination, blood biochemistry, coagulation function and blood pregnancy, etc.), imaging examination (MRI) and vital signs examination have abnormal results with clinical significance, and the researchers believe that they are not suitable for inclusion;
2. Active local or systemic infection;
3. Patients with lumbar tumors and/or spinal malformations;
4. Imaging showed calcification of the posterior longitudinal ligament;
5. A history of serious diseases of important organs (such as cardiovascular system, liver, lung, kidney and nervous system);
6. There are autoimmune diseases or abnormal coagulation function;
7. Previous or planned surgical procedures to fuse or stabilize the lumbar spine during the trial;
8. Intraoperative exploration of the location of the annulus fibriatus could not satisfy the requirement that the needle entry point was more than 2mm away from the margin of the annulus fibriatus;
9. Pregnant or lactating women, or those who have a pregnancy plan during the trial period;
10. Those who are participating in other clinical trials at the same time;
11. Other situations that the researcher considers inappropriate to participate in this study.
Safety Study of Treatment of Leg Fractures

This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.

This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the EVOS SMALL Plating System in subjects with proximal or distal (pilon or ankle) tibial fractures. Subjects will be recruited in the hospital emergency room or surgical department, at the point of identification of the need for ORIF surgery, and the decision is made to use the EVOS SMALL Plating System. The choice of medical and surgical treatment will be made independently by the Investigator in the regular course of practice and will not be influenced by this study protocol.

Approximately 100 subjects will be enrolled in order to ensure at least 90 evaluable subjects, with a minimum of 45 evaluable subjects having either a) proximal or b) distal tibial fractures.

Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative fracture resolution according to standard radiological practice (X-rays), clinical complications, reoperation rate, DRI, EQ-5D-5L, and pain VAS.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject who is 18 years of age or older at the time of signing the informed consent.
2. Subject provides an Institutional Review Board (IRB)-approved informed consent. The subject must have the physical and mental capacity to provide informed consent for him/herself.
3. Subject has experienced proximal tibial fracture (OTA Type 41 A-C) or distal tibial fracture (OTA 43 Type A-C) with or without fibular/malleolar involvement (OTA 44 A-C) and are scheduled for ORIF using the EVOS SMALL Plating System.
4. Subject is willing and able to attend all study visits including 1 year post-operative follow-up.

Exclusion Criteria:

1. Subject has contraindications or hypersensitivity to the use of the EVOS SMALL Plating System or its components (316L stainless steel).
2. Subject has a physical condition that, in the opinion of the Investigator, would preclude adequate implant support or retard healing, such as blood supply impairment, insufficient bone quality or quantity, previous infection, obesity, severe bow or gross bony distortion of the tibia, as detailed in the IFU.
3. Subject has, in the opinion of the Investigator, an emotional or neurologic condition that precludes cooperation and compliance with the rehabilitation regimen.
4. Subject is currently in another investigational drug, biologic, or device study or has been treated with an investigational product within the last 30 days.
5. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.
Application of Standardized Green Channel Treatment System for Ischemic Stroke in Xi 'an

Objective: To observe the practical application of the standardized green channel treatment system for stroke in Xi 'an in the real world. Methods: Clinical data and information of patients with acute ischemic stroke who received standardized green channel treatment for stroke were collected, and a multicenter observational clinical study was carried out in the real world to evaluate the prognosis, mortality, incidence of asymptomatic and symptomatic cerebral hemorrhage, incidence of pneumonia, and recurrence rate of stroke after 90 days.

The standardized green channel treatment system for acute ischemic stroke includes: Triage nurse triage timely, rapid assessment emergency doctor, suspected stroke the green channel, immediately start in the green channel of stroke accompanied by doctors and nurses stroke patients improve CT examination, intravenous thrombolysis or CT room, emergency room if considering large vascular lesions and the onset time in 6 hours, and rapidly to international for endovascular treatment, if the onset time of more than 6 hours, Rapid evaluation of ischemic penumbra and vascular occlusion by multi-mode imaging. If there are indications for endovascular treatment, go to the cath room for endovascular treatment as soon as possible.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old;
* Consistent with the diagnosis of acute ischemic stroke;
* 24 hours from onset to enrollment;
* Informed consent

Exclusion Criteria:

* Patients who refuse to receive intravenous thrombolysis or intravascular intervention (including intravascular mechanical thrombolysis and arterial thrombolysis);
* Stroke patients caused by brain tumor, brain trauma and blood diseases;
* Those with a history of stroke and sequelae affecting the outcome assessment, namely, mRS 2 points before the onset of this stroke;
* Combined with claudication osteoarthritis rheumatoid arthritis gout arthritis and other limb dysfunction and affect the neurological function examination;
* Patients with severe hepatic and renal insufficiency (Note: Hepatic insufficiency refers to ALT or AST values greater than 2 times the upper normal limit; Renal insufficiency refers to blood creatinine value greater than 2 times the normal upper limit);
* Suffering from other serious life-threatening diseases with an expected survival time of less than 3 months;
* Other diseases that limit neurological function evaluation or affect patient follow-up;
* A woman planning to be pregnant or breastfeeding;
* Currently participating in other clinical trials;
* Refuse to participate in the registration of investigators
Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.

The pharmacogenomic profiles of drug metabolizing enzymes play an important role in pharmacokinetics (PK) of drugs. Phenobarbital (PB), worldwidely used for neonatal seizure, is a drug that requires careful dose adjustments based on therapeutic drug monitoring. It was reported that phenobarbital (PB) metabolism was affected by CYP2C9 and CYP2C19 polymorphisms in adults. This study aims to evaluate the effects of the CYP2C9 and CYP2C19 genetic polymorphisms on PB PK in infants with neonatal seizure for an optimal dosing strategy.


Eligibility Criteria:
Inclusion Criteria:

* Infant treated by phenobarbital monotherapy, diagnosed neonatal seizure
* Infant taken the drug concentration one more time
* given the informed consent

Exclusion Criteria:

* progressed CNS disorder
* severe systemic illness
* GOT/GPT level more than 2times of normal value,more than 3times elevation of BUN/creatinine level
* congenital hemolytic anemia
* genetic disorder
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and pathological tumor volume with minimal residual disease (MRD)) as compared to ADT.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 18 and ≤75 years of age.
* All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1.
* All patients must complete mpMRI or 68Ga-PSMA PET / CT before and after neoadjuvant treatment.
* All patients must undergo thorough tumor staging and meet one of the following criteria: 1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ cT2c or cN+or locally advanced, 2. Gleason score of primary tumor ≥ 8, 3. prostate specific antigen (PSA) ≥20 ng/ml.
* Patients must have adequate organ function as defined by the following criteria(within 28 days prior to registration):

white blood cell (WBC) ≥ 4.0 × 109 / L platelets≥ 100 × 109 / L hemoglobin ≥ 9 g / dL international normalized ratio (INR) \< 1.5. total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN) SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN serum creatinine ≤2×ULN

* Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.

Exclusion Criteria:

* clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases.
* Prior androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy.
* severe or uncontrolled concurrent infections.
* New York Heart Association Class III or IV congestive heart failure at the time of screening.
* uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
* Patients with mental illness, mental disability or inability to give informed consent are not eligible.
* Patients have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods

This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine.


Eligibility Criteria:
Inclusion criteria:

* Samples of patients for whom blood culture and Multi Drug Resistant (MDR) surveillance tests were carried out in rectal swabs at the IRCCS Sacro Cuore Don Calabria Hospital
* Samples for which the Information and consent to the conservation of biological samples for research purposes has been signed at the Tropica Biobank or
* Samples for which, after all reasonable efforts, it was not possible to obtain the signature of the Information and consent to the conservation of biological samples for research purposes at the Tropica Biobank (e.g. patients in intensive care, immobilized patients unable to sign or with serious alterations of consciousness).

Exclusion criteria:

* Absence of data relating to positivity or negativity to the germs of interest
* Absence of stored residual material
The Effects of the Course on Technology Use in Nursing

This study aimed to examine the effect of the course on technology use in nursing on students' readiness for self-directed learning (SDLR) and attitudes toward technology. Research hypotheses are as follows:

* H1-1: The course on technology use in nursing affects nursing students' SDLR.
* H1-2: The course on technology use in nursing affects nursing students' attitudes toward technology.

The study has a quasi-experimental design. In the study, the intervention group participated in a 14-week course titled "Technology Use in Nursing," consisting of 2-hour weekly sessions. On the other hand, the control group attended a 14-week course titled "Health Assessment," also consisting of 2-hour sessions per week. Participants in the intervention group were given various tasks to enhance integration with technology. Students used various digital tools (such as Edpuzzle, artificial intelligence programs, mobile health applications, etc.). In the control group, participants were assigned the task of conducting interviews based on the Functional Health Patterns model in group work settings. No tasks involving digital tools were assigned to students in the control group.

Students were invited to participate in the study, and assignments to groups were made. After the group assignments, pre-tests were administered using the "Self-Directed Learning Readiness Scale" and the "Attitudes Toward Technology Survey." Post-tests were collected using the same scales at the end of the courses (week 14).

Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation in the study
* Enrollment in one of the elective courses: 'Technology use in nursing' or 'health assessment'
* Taking elective courses for the first time

Exclusion Criteria:

* Refusal to participate in the study at any stage of the research process
* Incomplete completion of the data collection forms
Ligamentoplasty of Ligamentum Tere Developmental Dysplasia of the Hip

The hip is formed by the acetabulum, the proximal femur and soft tissues joining them (capsule, teres ligament, transverse ligament and pulvinar). The acetabulum is a complex structure in the growing child. It is formed by the joined pubis, This junction is called tri radiate cartilage, which is responsible for acetabular growth. The external surface of the acetabulum is covered by a horse shoe-shaped articular cartilage. The transverse ligament joins both extremes of the articular cartilage inferiorly.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Developmental dysplasia of the hip (DDH) with :

  * Age: from 9 months -3 years old.
  * Virgin DDH.
  * Failed closed reduction in the management of DDH.
  * Failed open reduction through medial approach in the management of DDH.

Exclusion Criteria:

* • Paralytic hip dislocation .

  * Post septic hip dislocation.
  * Traumatic hip dislocation .
  * Age : below 9 months or above 5 years.
  * Refusal to participate in this study.
Cochlear Implants : Influence of Microphone Aging and Dirtying

Cochlear implant microphones are subject to aging and dirtying. The evolution may affect their efficiency. Several signal coding strategies are used in cochlear implants and their behaviour may be more or less affected by the aging process. In this work the investigators wish to assess this phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* French speaking persons (French native speakers; studies made in French)
* Ear, Nose and Throat (ENT) tests and check up for normal hearing listeners were normal (Hearing loss below 20 dBs for all frequencies situated in the 250-8000 Hz range)
* Not mentally retarded

Exclusion Criteria:

* Persons with tinnitus or headache
* Anxious people (taking psychiatric drugs)
* Mental alteration or mental retard
* Deafened persons or taking an ENT treatment (normal hearing listeners)