cyrilzakka/clinical-trials huggingface dataset:
A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants

The main purpose of this study is to evaluate the effect of multiple doses of carbamazepine (a strong inducer of cytochrome P450 \[CYP\]3A4 and a weak inducer of CYP2C9) on the pharmacokinetics of a single oral dose of erdafitinib in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, and vital signs (blood pressure, pulse, and body temperature) performed at screening
* Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel and hematology panel are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator. Participants must have sodium and phosphate levels within normal limits; hematological parameters (Hemoglobin, red blood cell \[RBC\] count, white blood cell \[WBC\] count, absolute neutrophil count, platelet count) within normal limits; and total bilirubin, alanine aminotransferase (ALT), aspartate amino transferase (AST), and alkaline phosphatase (ALP) serum levels lower than or equal to the upper limit of normal at screening
* Willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Must agree to have a pharmacogenomic blood sample (5 milliliters \[mL\]) collected at screening to allow for pharmacogenomic analysis
* Non-smoker for at least 6 months before first study drug administration

Exclusion Criteria:

* History of depression or suicidal ideation
* History or current evidence of ophthalmic disorder, such as central serous retinopathy (CSR) or retinal vein occlusion, active wet age-related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation, or ulceration
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (a maximum of 3 doses per day of 500 milligram \[mg\] paracetamol, and no more than 3 gram \[g\] per week), hormonal replacement therapy and cetirizine (in case of allergic reactions), within 14 days before the first dose of the study drug is scheduled until completion of the study
* Received an experimental drug or used an experimental medical device within 1 month or within a period less than 5 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
* Known allergies, hypersensitivity, or intolerance to erdafitinib or carbamazepine or any of the excipients of the formulations
A Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice

This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained


Eligibility Criteria:
Inclusion Criteria:

1. Use rebenin ® for painless gastroscopic sedation and painless colonoscopic sedation
2. Patients need to sign informed consent

Exclusion Criteria:

1. Patients who are participating in or planning to participate in any interventional clinical trial
2. The investigator considers that there are any other reasons for the patient's ineligibility for the study
Mandala Art and Value Clarification With Parents of Children With Cancer

The research is planned to be conducted with a randomized controlled experimental study. In the research, it is aimed to determine the effect of mandala drawing art and value clarification application based on Watson Human Care Theory on the anxiety and mood of the parents of children with cancer.

The population of the study consists of the parents of children diagnosed with cancer in the Akdeniz University Hospital Pediatric Hematology and Oncology Clinic. The sample of the study is three groups; intervention 1 group (n:25), intervention 2 group (n:25) and control group (n:25) will consist of a total of 75 parents. A closed envelope system with simple randomization will be used in sample selection.

Intervention 1 group will participate in 2 sessions of individual mandala drawing art activity with the theme of 'Emotions' accompanied by classical or instrumental music. In each session, a mandala will be created. Intervention 2 groups will participate in the value clarification activity by writing 2 sessions individually with the theme of 'Emotions' accompanied by classical or instrumental music. Personal Information Form, State Anxiety Inventory and Positive-Negative Affect Scale were administered to the intervention groups at the first meeting in order to collect pre-test data. To collect post-test data, the State Anxiety Inventory and the Positive-Negative Affect Scale were administered immediately after the second session. No intervention will be made to the control group, the same data collection tools were applied to the intervention groups.

In addition, Iin the second session, the parent was asked to interpret the colors and shapes in the mandala created by the parent and a face-to-face interview was held.

Eligibility Criteria:
Inclusion Criteria:

* Having the ability to read, write, speak and understand Turkish
* Being the parent of a 0-17-year-old child diagnosed with cancer
* Staying in the hospital with child
* Being hospitalized for at least the second course of treatment of the child

Exclusion Criteria:

* Having a physical problem that may prevent you from drawing and typing a mandala and participating in value clarification
* Not being able to take a break from caring for their child and participate in individual activities
* Having the child in the terminal period
* Relapse disease of the child
Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis

The aim of this study is to evaluate the diagnostic performance of FEUrea for the differential diagnosis of AKI in patients with cirrhosis and ascites Specifically, the ability of FEUrea to distinguish between ATN versus Pre renal azotemia and HRS.

AKI according to KDIGO guidelines is defined as the followings:

* An increase in serum creatinine by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 h
* An increase in serum creatinine to ≥1.5 times baseline within the previous 7 days
* Urine volume ≤0.5 ml/kg/h for 6 h Serum creatinine overestimates renal function in cirrhotic patients due to a number of factors: Creatinine production in patients with cirrhosis is reduced due to muscle wasting, there is an increased secretion of creatinine in the renal tubules, sCr may be diluted due to an increased volume of distribution, and finally, high bilirubin levels may interfere with the assays to measure its level. Recently, the International Club of Ascites (ICA) has adopted the concept of AKI which was developed originally to be used in general critically-ill patients. AKI is defined as the increase of at least 0.3 mg/dL (26 μmol/L) and/or ≥ 50% from baseline, within 48 hours Since urea absorption is largely modulated in the proximal tubules, it is not affected by diuretics acting more distally. The investigators therefore hypothesized that the fractional excretion of urea (FEUrea) could serve as a clinical aid in making an early distinction between ATN versus Pre renal azotemia and HRS type 1 in patients with cirrhosis and ascites presenting with AKI Fractional excretion of urea (FEUrea) (\[urine urea nitrogen/ blood urea nitrogen)/(urine creatinine/plasma creatinine)\] X 100) \< 35% is specific for prerenal azotemia, and \> 50% is specific for ATN

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis of any etiology diagnosed by clinical parameters involving laboratory tests, endoscopic or radiologic evidence of cirrhosis,
* History of decompensation (hepatic encephalopathy, ascites, variceal bleeding, jaundice)
* Age greater than 18 years
* Presence of moderate or severe ascites

Exclusion Criteria:

Patients excluded from analysis were those who did not meet inclusion criteria as well as the following

* Prior liver or kidney transplant,
* Advanced chronic kidney disease G4(GFR category grade 4) according to KDIGO guidelines.
* Patients on acute or chronic renal replacement therapy,
* Ambiguous diagnosis of AKI and phenotype of AKI,
* Patients with hepatocellular carcinoma.
Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line

In vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line.

This study is conducted to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line. The primary outcome is apoptosis, while the secondary outcome is cell viability.

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma cell lines (OSCC, TSCC and HNSCC).
* Luteolin 5,7,3',4'-tetrahydroxy-flavone (MeSH term).
* Application of luteolin as a chemotherapeutic drug.

Exclusion Criteria:

* Any cancer cell line other than OSCC, TSCC and HNSCC cell lines.
* Luteolin glycosides.
Prediction Model of CP-EBUS in the Diagnosis of Lymph Nodes

Endobronchial ultrasound (EBUS) multimodal image including grey scale, blood flow doppler and elastography, can be used as non-invasive diagnosis and supplement the pathological result, which has important clinical application value. In this study, EBUS multimodal image database of 1000 inthoracic benign and malignant lymph nodes (LNs) will be constructed to train deep learning neural networks, which can automatically select representative images and diagnose LNs. Investigators will establish an artificial intelligence prediction model based on deep learning of intrathoracic LNs, and verify the model in other 300 LNs.

Intrathoracic LNs enlargement has a wide range of diseases, among which intrathoracic LNs metastasis of lung cancer is the most common malignant disease. Benign lesions, including inflammation, tuberculosis and sarcoidosis, also need to be differentiated for targeted treatment.

EBUS multimodal image including grey scale, blood flow doppler and elastography, can be used as non-invasive diagnosis and supplement the pathological result, which has important clinical application value. This study includes two parts: retrospectively construction of EBUS artificial intelligence prediction model and multi-center prospectively validation of the prediction model. A total of 1300 LNs will be enrolled in the study.

During the retention of videos, target LNs and peripheral vessels are examined using ultrasound hosts (EU-ME2, Olympus or Hi-vision Avius, Hitachi) equipped with elastography and doppler functions and ultrasound bronchoscopy (BF-UC260FW, Olympus or EB1970UK, Pentax). Multimodal image data of target LNs are collected.

Investigators will construct artificial intelligence prediction model based on deep learning using images from 1000 LNs firstly, and verify the model in other 300 LNs. This model will be compared with traditional qualitative and quantitative evaluation methods to verify the diagnostic efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Chest CT shows enlarged intrathoracic LNs (short diameter \> 1 cm) or PET / CT shows patients with increased FDG uptake (SUV ≧ 2.0) in intrathoracic LNs;
2. Operating physician considered EBUS-TBNA should be performed on LNs for diagnosis or preoperative staging of lung cancer;
3. Patients agree to undergo EBUS-TBNA, sign informed consent, and have no contraindications.

Exclusion Criteria:

- Patients having other situations that are not suitable for EBUS-TBNA.
Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

The purpose of this study is to measure efficacy and safety with SHJ002 sterile ophthalmic solution compared to vehicle in participants with Dry Eye Disease (DED). SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.

Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye BID for 84 days.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
2. Have DED in both eyes for ≥ 6 months
3. Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test

Exclusion Criteria:

1. Ocular surface corneal disease, other than DED.
2. Lid margin disorder other than meibomian gland dysfunction (MGD)
3. Presence of any ocular condition
4. Any history of eyelid surgery or intraocular/ocular surgery
5. Cauterization of the punctum or punctal plug
6. Use of lid scrubs containing chemicals or baby shampoo, or eye makeup
7. Use of any of the contraindicated drugs medications
8. Any changes in the dosing of any chronically used systemic drug
9. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
10. Known history of alcohol and/or drug abuse within 12 months
11. Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents.
12. Participation in any drug or device clinical investigation within 30 days
Psychosocial Mobile Application (THRIVE-M) for Patients With Multiple Myeloma

This clinical trial aims to evaluate whether a psychosocial mobile application (THRIVE-M), is efficacious for improving quality of life, psychological distress, and fatigue in patients living with multiple myeloma compared to usual care.

Multiple myeloma, the second most common hematologic malignancy, can be associated with severe end-organ destruction and life-threatening complications (e.g., kidney failure, infection, anemia) resulting in significant morbidity (e.g., pain syndromes, fatigue). The protracted course and treatment of multiple myeloma is also characterized by physical symptoms that can undermine psychological well-being, functioning, and quality of life across the illness trajectory and care continuum.

Despite the high psychological burden that may accompany life with multiple myeloma, the special mental health workforce needed to adequately address their psychological needs is limited. Hence, mobile application-delivered psychosocial interventions offer an innovative approach to overcome the shortage of psychosocial services to support the unique needs of patients living with multiple myeloma. With no psychosocial mobile application interventions for patients living with multiple myeloma, we developed a patient-centered, population-specific, mobile-application psychosocial intervention, THRIVE-M, tailored to the unique needs of patients living with multiple myeloma. With this study, we will establish the impact of THRIVE-M on patient-reported outcomes compared to usual care.

The study will use validated questionnaires to measure patients' quality of life, psychological distress symptoms, fatigue, and self-management targets like coping, spiritual well-being, and self-efficacy. Study questionnaires will be completed in the hospital or clinic, with an option to also complete them remotely via a secure web link or a mailed paper copy.

Divine Mercy University is funding this research study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18 years or older) with one of the following diagnoses:

  1. newly diagnosed multiple myeloma receiving first-line therapy,
  2. multiple myeloma on maintenance therapy, or
  3. relapsed multiple myeloma receiving 2nd or 3rd line therapy
* Ability to comprehend, read, and respond to questions in English

Exclusion Criteria:

- Patients with acute or unstable psychiatric or cognitive conditions that the treating clinicians believe prohibit informed consent or compliance with study procedures
Cold Water Immersion in the Recovery of Markers of Muscle Damage of 10km Street Runners

Objective: To analyze the effect of cold water immersion (CWI) on the recovery of clinical, biochemical, functional and neuromuscular markers of muscle damage in 10 km street runners.

Materials and Methods: This is a randomized, blinded trial in which 30 subjects, 10 km street runners, were randomly divided into three groups: control (gC), immersion (gI) and CWI (gCWI). The runners will be evaluated for clinical (subjective perception of exertion), biochemical (serum CK), functional (unipodal triple hop distance and shuttle test time) and neuromuscular variables by means of isokinetic variables (peak torque, total work and fatigue index). Volunteers will perform pre-assessment, immediately post-race and post-intervention, and 24-hour post-intervention. The data will be expressed by mean and standard deviation, analyzed in the statistical package SPSS 20.0. A significance level of 5% and a 95% confidence interval will be considered for all measures.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 18.5 and 30 kg/m2;
* Street runners for at least 6 months;
* Week frequency of at least 3 times;
* Do not present cardiopathies, muscles and neurological diseases;

Exclusion Criteria:

* Hypersensitivity or allergies to cryotherapy;
* Unable to complete the 10 km event on the day of the evaluation;
* Do not complete or perform any of the study procedures for any reason (phobias, do not withstand the exposure time).
Disease Management for Smoking Cessation

The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for smoking. The hypotheses are to compare abstinence from cigarettes, the number of quit attempts, and smokers motivation at 24 months between participants receiving high and low intensity disease management and those receiving usual care.

The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for nicotine dependence. In this study, we will recruit 750 smokers from 20 rural, primary care clinics in Kansas. Subjects will be randomly assigned to one of three study arms, each providing 20 months of treatment: C (comparison group), LDM (low-intensity disease management) or HDM (high-intensity disease management). Participants in group C will receive health educational mailings and an offer for free nicotine replacement therapy (six weeks) or bupropion (seven weeks) every 6 months (months 0, 6, 12, and 18). Participants in LDM will receive the same interventions as C plus a low-intensity disease management program that includes a single telephone counseling session using motivational interviewing (MI) at months 0, 6, 12, and 18 to encourage a cessation attempt and also includes coordination of smoking assessments and pharmacotherapy with the patient's physician. HDM participants will receive C plus a high intensity disease management program that includes up to six telephone-based MI counseling sessions at months 0, 6, 12, and 18 to encourage a smoking cessation attempt and to prevent relapse after a quit attempt, as well as coordination of smoking assessments, quit attempts, and pharmacotherapy with the patient's physician.

The primary outcome of the study is 7-day point prevalence abstinence from cigarettes at 2 years after enrollment. Secondary outcomes include: 1) number of quit attempts and 2) progress in stage of change. If successful, this intervention will provide a generalizable model for addressing nicotine dependence that could improve long-term management of smoking in primary care.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Reported smoking at least 10 cigarettes per day for at least 25 of the last 30 days
* Speak English
* Their regular physician is a participating physician
* Working home telephone or cellular phone

Exclusion Criteria:

* Women who are pregnant or planning to become pregnant in the next two years
* Plan on moving within two years
* Display signs of dementia or other mental disorders
* Live with a smoker already enrolled
The Fixation Study

To perform a clinical evaluation of safety and performance for the SeaSpine Non- Cervical Pedicle Screw Systems

A multi-center, post-market, clinical evaluation for subjects implanted with the SeaSpine Non-Cervical Pedicle Screw Systems

Eligibility Criteria:
Inclusion Criteria:

* Have undergone surgery
* Have undergone at least 12-months of postoperative follow-up

Exclusion Criteria:

* Any condition that the Investigator determines is unacceptable
Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women

The broad aim is to determine efficacy of a weight loss diet higher in protein and lower in carbohydrate combined with low intensity exercise to favorably impact body composition, bone health, physical function, metabolic disease and quality of life compared to a conventional higher carbohydrate diet in overweight women over age 60.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \> 28 kg/m²
* Clearance of primary physician to participate in diet and mild exercise

Exclusion Criteria:

* Medical condition contraindicating prescribed diet and exercise regimen
* Type 2 Diabetes Mellitus
* Physically active lifestyle (\>30 min moderate physical activity 2+ times weekly)
Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance

This study is designed to evaluate the effect of early albumin transfusion within massive transfusion protocol on fluid balance and reduced requirement of transfusion.

Eligible patients who require massive transfusion will be randomized in a single-blind manner (participant) in a 1:1 ratio to Conventional Massive Transfusion Pro. tocol group (C-MTP) or Albumin Massive Transfusion Protocol group (A-MTP). When MTP is initiated according to the result of randomization, all patients(or a legal guardian) are informed about the study and potential risks and benefits. Study will be continued only in patients who give informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (19 or older)
* Admitted or planned to admit surgical intensive care unit
* Patients with decreased hemoglobin level more than 20% from baseline within 12 hours, Or
* Patients who are suspected bleeding and hemodynamically unstable requiring more than 0.05mcg/kg/min of norepinephrine infusion to maintain mean blood pressure higher than 65mmHg

Exclusion Criteria:

* Contraindicated to albumin product
* patients with risk factors of increased circulatory volume (heart failure, pulmonary edema, end-stage renal disease with oliguria)
* patients with hemolytic anemia
* History of anaphylactic reaction to blood product