cyrilzakka/clinical-trials huggingface dataset:
Assessment of COVID-19 in Tearfilm

To assess the co-relation of COVID-19 in nasopharyngeal swabs and tears or saliva, and to determine duration of COVID-19 activity in ocular fluid and saliva by serial tests over 3 months.

Patients who underwent COVID-19 testing at VUMC (Vanderbilt University Medical Center) and had provided a written informed consent to be contacted in the future for COVID related studies will be offered participation in this study. The COVID- 19 has low prevalence in ocular fluids (5% of affected patients) but may survive for a long time or replicate in the conjunctiva, even in asymptomatic patients. Patients with viral conjunctivitis are more likely to have COVID-19 RNA (ribonucleic acid) in tears. The use of Schirmer's strips to collect tears for RNA analysis of viruses has been previously validated. VUMC is performing RNA analysis on nasopharyngeal (NP) swabs for COVID-19 at several locations. Several patients (test positive and test negative) have given consent to be contacted for future research purposes and are available in VICTR (Vanderbilt Institute for Clinical and Translational Research) Datamark and Recovery databases. The positive tested patients will receive a Schirmer's strip in the mail at their home to place in both eyes to test eye fluid and receive a tube for saliva while engaging in a zoom session for monitoring of the process.

Methodology: Patients who underwent COVID-19 testing at VUMC and had provided a written informed consent to be contacted in the future for COVID related studies will be offered participation in this study. The first test for eye fluid and saliva will occur at home with remote monitoring. Participants will be mailed a specimen collection kit, engage in a remote session with a study coordinator through a HIPPA (Health Insurance Portability and Accountability Act of 1996)-compliant video meeting and collect specimens under supervision of the study coordinator. Patients will receive a Schirmer's strip to place in both eyes without topical proparacaine, and a tube to collect saliva. The strips are then sent to the lab in universal viral transport media. Patients who have positive COVID-19 RNA in tears will get repeat Schirmer's test every 4 weeks for 3 months- independent of the nasopharyngeal test results. After a 3-month period, they will be offered a clinic visit at VEI (Vanderbilt Eye Institute) for full dilated eye exam, fluorescein angiography and aqueous biopsies. Lab testing for COVID-19 RNA and other ocular inflammatory mediators will be performed by Dr. Johnathan Schmitz's lab at VUMC under standard viral precautions. All lab analysis will be performed under a research protocol and not for clinical assessment or reporting.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent COVID-19 testing at VUMC, tested positive, and had provided a written informed consent to participate in future COVID related studies will be offered participation in this study.

Exclusion Criteria:

* Patients under 18.
* Patients who do not speak Spanish or English
Digital Storytelling in Pediatric Safe Drug

Summary Aim: This research was conducted to determine the effectiveness of education given to students using digital storytelling in safe pediatric intravenous drug administration.

Method: It is a randomized controlled experimental study. The sample of the study consisted of 84 nursing students. The students included in the study were divided into two equal groups: the experimental and control groups. Digital education material of the experimental group and theoretical education was applied to the control group. Before and after the training, a post-knowledge test was made and evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Being a student of the Department of Nursing
* Taking the child health and diseases nursing course and being successful
* Volunteering to participate in the research

Exclusion Criteria:

* Participate and quit the study
* Being a 1st and 2nd year nursing student
* Failure of the child health and diseases nursing course
Biomarkers of Metabolic Syndrome and Prediabetes

The purpose of this study is to investigate the feasibility of using salivary biomarkers to screen for complications of metabolic syndrome including prediabetes.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65 years
* Males and females will be included in this study
* All ethnic backgrounds will be included in this study
* Acceptable health based on interview and medical history
* Ability to comply with requirements of the study
* Ability and willingness to provide signed informed consent

Exclusion Criteria:

* Eating or drinking anything but water within 10 hours of sample collection
* Autoimmune disease
* Type 1 diabetes
* Pregnancy (\< 6 weeks postpartum)
* History of Sjorgren's Syndrome
* Dental work within the last two weeks
* Ongoing or active parasitic, fungal, viral or bacterial infection
Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices

The use of the video laryngoscope to teach laryngoscopy will improve the performance of tracheal intubation done by novices because it will allow a shared view of the airway leading to a better feedback from the trainer to the trainee.

A group of 30 fourth year medical students and interns rotating through the department of anesthesiology will be studied. Firstly, a standard lecture will be provided in which the description and importance of laryngoscopy and tracheal intubation will be explained. This will include descriptions of anatomy, relevant equipment and technique of tracheal intubation. Following the lecture , the students will be randomly allocated using sealed envelopes into two groups : a control group ( taught with a standard Macintosh Laryngoscope ) and a study group ( taught with the Airtraq video laryngoscope).Each group will receive a demonstration and verbal instruction on how to perform laryngoscopy and tracheal intubation by their instructor.

Eligibility Criteria:
Students:

Inclusion criteria for the medical student:

* Medical student or intern rotating through the anesthesiology department

Exclusion criteria for the medical student:

* Previous attempts of laryngoscopy in humans
* Subject who refuses participation

Patients:

Inclusion Criteria:

* Age 18 -75 years of age
* ASA PS I, II
* Procedure that will require General anesthesia with tracheal intubation

Exclusion Criteria:

* Age \< 18 years old or greater than 75 years of age
* Patient or student who refuses participation
* ASA Physical status class III or greater
* History of lung disease
* History of obstructive sleep apnea
* History of difficult intubation
* Evidence of possible difficult airway (Mallampati Class \>2, TMH distance \<6 cm, mouth opening \<4 cm and limited neck mobility)
* Unanticipated difficult laryngoscopy (defined by inability of the attending anesthesiology to intubate after 2 attempts)
* Patients at risk for aspiration
* Patients with BMI greater than 35
* Pregnant patients
Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery

This research trial will measure how useful Aprepitant is in preventing nausea and vomiting in children having surgery to correct scoliosis (curvature of the spine).

Detailed Description: This prospective, randomized, controlled trial will test whether adding Aprepitant to standard multimodal therapy regimen can further reduce the incidence and severity of post-operative nausea and vomiting (PONV) in children undergoing posterior spinal instrumentation and fusion. The primary outcome of the study will be anti-nausea rescue medication administration post-surgery, with secondary outcomes being the first instance of post-surgery anti-nausea rescue medication administration, emesis, headache, flatus, bowel movement, and sensation of itch; incidence of treatment-emergent adverse events; and worst nausea and pain scores post-surgery .

Eligibility Criteria:
Inclusion Criteria:

* Posterior Spinal Instrumentation and Fusion (PSIF) for idiopathic scoliosis
* The fusion must include at least 6 vertebral levels.
* Children greater than or equal to 8 years old, and less than 19 years old on the day of surgery
* Weight \> 40kg - for ease of pharmacy preparation (PONV dose 1mg per kg to max 40mg)

Exclusion Criteria:

* Patient/ Parent refusal
* Hypersensitivity to Aprepitant or any ingredient in the formulation or oral solution. (previous allergy or adverse reaction to Aprepitant)
* Developmental delay as reported by parents
* Pregnant - Pregnancy test done as standard of care pre-operative
* Severe systemic disease ASA classification III or greater
* Concurrent use of any medication with severe interaction with Aprepitant as outlined in product monograph.
* Neuromuscular or congenital scoliosis
* Inability to take PO medications
A Prospective Study of Cadonilimab in Hepatocellular Carcinoma After Radical Surgery with High Risk of Recurrence

This study aims to compare the safety and tolerability of cadonilimab applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrent factors.

Hepatectomy and local ablation are the main curative treatment methods for hepatocellular carcinoma, but the 5-year recurrence rate after surgery is as high as 70%, which is the main bottleneck problem affecting the long-term prognosis of patients. This study aims to investigate the safety and tolerability of cadonilimab (PD-1/cytotoxic T lymphocyte antigen-4 (CTLA-4) bispecific antibody) applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrence factors.

Eligibility Criteria:
Inclusion Criteria:

* Sign a written informed consent before the implementation of any trial-related procedures.
* Male or female, aged ≥18 years and ≤70 years.
* ECOG PS score is 0 - 1 point.
* Subjects diagnosed with hepatocellular carcinoma by imaging criteria and/or pathology and who have received curative resection.
* The definition of curative resection complies with the definition of curativeness in the 2024 edition of the Chinese Guidelines for Primary Liver Cancer (CNLC).
* The postoperative recurrence risk stratification conforms to the high - risk group in the ERASL - pre or ERASL - post formula.
* No prior systemic antitumor treatment for hepatocellular carcinoma has been received.
* Child - Pugh liver function score of grade A or B7.
* Expected survival time \> 6 months.

Exclusion Criteria:

* Previously diagnosed by histology/cytology, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
* Subjects with other malignant tumors within 5 years before enrollment, except for HCC. Subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.
* History of hepatic encephalopathy or liver transplantation.
* Portal vein trunk or mesenteric superior vein, inferior vena cava tumor thrombus.
Lipoic Acid as a Treatment for Acute Optic Neuritis

The purpose of this study is to determine if oral lipoic acid can safely help relieve permanent optic nerve injury in patients diagnosed with acute optic neuritis. It will also explore how the body absorbs and breaks down the study drug, and what effects it has on the immune system.

Oral lipoic acid is an antioxidant that helps proteins work in the body. It is available in oral and intravenous formulations and has been used in the past to treat nerve damage like that seen in diabetes and some other metabolic disorders. It is available as a dietary supplement in the United States.

Patients with a diagnosis of acute optic neuritis who are enrolled in the study will undergo medical and nervous system examinations, and blood draws. The study doctor will take a medical history and perform physical examinations. Research assistants at the MS Center, who are trained in blood draws, will perform the blood draws. Patients will also undergo Optical coherence tomography (OCT) examination at Casey Eye Institute, and receive two MRIs at Oregon Health and Science University (OHSU). Because it is a placebo-controlled trial, subjects will have a 50:50 chance of receiving either placebo (inactive) or study drug. If enrolled in the study, patients will take two gel capsules of the study drug or placebo at the same time every day for six weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute, unilateral AON with visual symptoms (vision loss) of 14 days or less
* 18 - 65 years of age, inclusive
* AON as a first event (possibly idiopathic) or in relationship to clinically isolated syndrome or to MS according to McDonald criteria
* No previous history of optic neuritis or ophthalmoscopic signs of optic atrophy in the affected eye
* Subject is available for treatment initiation within 14 days of onset of AON symptoms

Exclusion Criteria:

* Other causes of visual loss in the affected eye (e.g. amblyopia or glaucoma
* OCT is non-evaluable at screening visit due to edema.
* AON symptoms improve before administration of study medication.
* Subject has fever or active infection at time of enrollment.
* Subject is pregnant or breast-feeding.
* Subject has diabetes mellitus.
* Subject has another significant health problem (e.g. active coronary heart disease, liver disease, significant pulmonary disease).
A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants greater than or equal to 18 years of age
* Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
* PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory
* Measurable disease, as defined by RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed:

Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC discontinued \>7 days prior to Cycle 1, Day 1

* Central nervous system (CNS) disease, including treated brain metastases
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted
* Active hepatitis B or hepatitis C
* Human Immunodeficiency virus (HIV) positive
* Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Lopinavir/Ritonavir (Kaletra) PK in Children

The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets. The study is a randomized,open-label, crossover study of pediatric subjects already taking lopinavir/ritonavir tablets as part of their clinical care. THe investigators hypothesize that lopinavir exposure in pediatric patients will be lower after taking a dose of the tablet formulation, crushed and mixed with pudding or yogurt, as compared to the exposure after taking a dose with tablets swallowed whole.

By the end of 2005, approximately 2.3 million children worldwide were living with HIV/AIDS.1 At least 660,000 children worldwide have advanced HIV/AIDS and are in dire need of antiretroviral treatment. While many barriers exist to scaling up HIV/AIDS care and treatment globally, access to life-saving treatments for children is increasing. The protease inhibitor, lopinavir/ritonavir (Kaletra®), is recommended as a first-line agent by the World Health Organization and by the US Department of Health and Human Services for the treatment of pediatric patients in resource-limited settings and in the United States.

The prescribing information states that these tablets may not be crushed, broken or chewed, and the manufacturer does not plan to examine the pharmacokinetics of crushed tablets at this time. The company found that the crushed tablets were poorly absorbed in a small pharmacokinetic study in several dogs. While this information has spread through investigators by word-of-mouth, this information has not been published in any forum by the company, and no guidance as to the extent of the decrease in absorption has been provided. However, patients and caregivers are dosing pediatric patients with crushed tablets to overcome some of the limitations of the oral solution. If crushed tablet administration yields significantly lower systemic exposure to lopinavir than whole tablets, then patients using this administration technique will be at higher risk for development of viral resistance and treatment failure. This administration technique must be studied so that providers have evidence to support recommendations about this dose administration strategy.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* Taking lopinavir/ritonavir (Kaletra) tablets at standard pediatric doses for greater than two weeks
* Concomitant medications and/or natural products, including potentially interacting products, have been stable for greater than two weeks and are not expected to change over the course of the study
* Ability to understand study procedures and assent to participate
* Parental or guardian consent
* Aged 6 - 17 years

Exclusion Criteria:

* Acute serious medical illness or infection (in the judgment of the investigator)requiring treatment and/or hospitalization within 14 days prior to study entry
* Pregnancy
* Concomitant medications/natural products that have been started within past two weeks and/or that will be changed over the course of the study.
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)

This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.

This is a prospective, single-arm, multi-center, real-world study of an approved device. Up to 500 patients will be enrolled in this study at up to 45 sites in Europe. All enrolled patients will be assessed at the following intervals: baseline, index procedure, discharge (or 7-days post-index procedure whichever occurs first), 30 days, 1 year, and annually through 5 years.

Study enrollment is expected to last approximately 2-4 years, followed by 5 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use.
2. Patient agrees to attend follow-up assessments.
3. Patients provided written informed consent for participation in the study.

Exclusion Criteria:

1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).
2. Any patient considered to be part of a vulnerable population.
Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy

This study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.

Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18\~70,both gender.
2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
3. Patients are willing to receive eradication treatment.
4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria:

1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
2. Contraindications to study drugs.
3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
4. Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening)
5. Pregnant or lactating women.
6. Underwent upper gastrointestinal Surgery.
7. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
8. Evidence of bleeding or iron eficiency anemia.
9. A history of malignancy.
10. Drug or alcohol abuse history in the past 1 year.
11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
12. Enrolled in other clinical trials in the past 3 months.