cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Compare Pharmacokinetics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012

To compare and evaluate safety and pharmacokinetic Characteristics after administration of ATB-101 or co-administration of ATB-1011 and ATB-1012 in fasted Healthy Adult Volunteers

Pharmacokinetic endpoints

1. Primary endpoint : AUCt, Cmax of Dapagliflozin, Olmesartan
2. Secondary endpoint : AUC∞, Tmax, t1/2, CL/F, Vd/F of Dapagliflozin, Olmesartan

Safety evaluation

1. Adverse reactions (but only in case of TEAE)
2. Concomitant drugs
3. Vital signs
4. Laboratory test

Eligibility Criteria:
Inclusion Criteria:

* Those who are over 19 years old at the screening visit
* Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit
* Those who determined as suitable study subjects by the principal investigator
* A person who signs the consent form at will, after hearing and understanding a sufficient explanation of the purpose, contents, characteristics of the investigational product, and expected adverse reactions of this clinical trial

Exclusion Criteria:

* Those who have a clinically significant disease or have a history of such disease
* Those who have a history of gastrointestinal surgery
* Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs
* Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
* Those who donated whole blood within 2 months or donated components within 2 weeks, or received a blood transfusion within 1 month of the first administration date
Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)

The purpose of this trial is to study the safety and immune response to measles, mumps, and rubella in children who were vaccinated with an investigational measles-mumps-rubella live vaccine made with artificially made human protein.

The duration of treatment is 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children 12 to 18 months of age

Exclusion Criteria:

* History or prior exposure to measles, mumps, or rubella
* History of allergic reactions to any component of the vaccines as evaluated by the study doctor
Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System

The study proposes to evaluate a patient navigation intervention among a sample of 446 individuals referred for CT-based lung cancer screening in an urban safety-net setting.

Widespread implementation of CT-based lung cancer screening is underway, but its impact on cancer morbidity and mortality can only be achieved IF people are screened at appropriate intervals and abnormal findings are appropriately assessed. The degree to which individuals, especially those from medically underserved populations with highest lung cancer risks, will adhere to the complex, multi-step process of CT-based lung cancer screening has emerged as a key question with immediate need for solution. Specific aims of the study are as follows:

* Aim 1: Compare rates of completion for clinically recommended steps in the lung cancer screening process between patients referred for CT-based lung cancer screening who are randomized to the navigation intervention versus patients who receive usual care.
* Aim 2: Compare changes in patient-reported outcomes, including satisfaction with care, psychosocial distress, and tobacco use between patients in the navigation intervention versus those who receive usual care for the CT-based lung cancer screening process.
* Aim 3 (Exploratory): Explore whether differences seen in Aims 1 and 2 are moderated theory-based patient attitudes and beliefs (perceived susceptibility, severity of lung cancer, perceived benefits/barriers to screening, self-efficacy).

This study will offer unprecedented insight into implementation of lung cancer screening for high-risk individuals in underserved settings. Findings will show whether navigation interventions increase adherence to the screening process and affect patient-reported outcomes among underserved populations. The proposed program aims to address these issues for lung cancer screening at its inception, rather than after disparities in screening uptake have already emerged.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for lung cancer screening using a low-dose CT scan modality who are considered high risk by USPSTF guidelines.
* Patients who speak English or Spanish

Exclusion Criteria:

* Patients who do not speak English or Spanish
* Patients who are or become ineligible as defined by USPSTF guidelines for lung cancer screening.
A Study to Assess the Immunogenicity and Safety of CSL's 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers

This is a study to assess the immune (antibody) response and safety of the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 years or older at the time of vaccination.
* Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Exclusion Criteria:

* Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
* Clinical signs of an active infection.
* A clinically significant medical condition.
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
* Females who are pregnant or lactating.
ONO-4538 Phase I Study in Patients With Solid Tumor

The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 20 years of age
* Histologically or cytologically confirmed solid tumor
* Patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available
* ECOG Performance Status is 0 to 1

Exclusion Criteria:

* Current or prior severe hypersensitivity to another antibody product
* Multiple primary cancers
Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery

This is a long-term follow-up of a completed clinical trial which compared percutaneous coronary intervention (PCI) using sirolimus-eluting stents and coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease.

The purpose of the study is to obtain retrospective long-term data on clinical outcome of the study population.

The randomized multicenter, open-label trial "Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis" was conducted at 4 tertiary care centers in Germany. 201 patients with unprotected left main stem stenosis (≥50%) with or without additional multivessel coronary artery disease were enrolled in a 1:1 ratio from July 2003 through February 2009. Results were published: https://pubmed.ncbi.nlm.nih.gov/21272743/

Long-term follow-up will be performed by a structured telephone interview using a standardized questionnaire by an interviewer blinded to treatment allocation. Wherever possible, data will be completed and verified by health care records. Retrospective data of the underlying randomized study will be included in data analysis.

Eligibility Criteria:
Inclusion Criteria:

* alive participants of underlying study who give their consent to participate
* deceased participants of underlying study

Exclusion Criteria:

* alive participants of underlying study who do not consent
Development of Physical Activity Features for Ear-worn Devices

This study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices.

This exploratory study involves data collection of adults performing physical activities and activities of daily living for the purpose of comparing data collected by the ear-worn device under test and established gold standard/reference devices and consumer electronic devices. Data collected will be used in the development of software features related to physical activities to benefit the experience of ear-worn device users.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 - 85
* Minimum height 5'3"
* Fully vaccinated against Covid -19
* Willing and able perform various exercise activities at a light and moderate relative intensity, such as riding a stationary bike, walking and jogging on a treadmill, and performing squatting movements.
* Non-smoker for the past 6 months.
* Willing to abstain from caffeine and alcohol 6 hours before participation.
* Willing to fast from eating 4 hours before participation.

Exclusion Criteria:

* History of chronic heart disease or significant cardiac events (e.g. cardiac arrythmia).
* Diagnosed with diabetes mellitus or other metabolic disorder.
* History of cerebral vascular accident.
* History of pulmonary disorder.
* Experiencing orthopedic injury or disorders that restrict movement or cause painful physical activity.
* History of neurodegenerative or neuromuscular pathology.
* Advised by a healthcare professional to not participate in physical activity.
Impact of Glasses for Vision Problems on Cognitive Function in Rural Older Adults

The aim of this project is to explore whether vision correction can effectively slow cognitive decline in older adults.

The primary question it seeks to answer is: Can providing free near and/or distance vision correction glasses to older adults with refractive errors or uncorrected vision, who have normal baseline cognition and hearing, reduce the rate of cognitive decline over 36 months in a cost-effective manner? Researchers will compare the rate of cognitive decline over 36 months between older adults who receive refractive correction and those who do not.


Eligibility Criteria:
Inclusion Criteria:

* Older adults who meet all of the following criteria will be eligible to participate in this study:

  * Age ≥ 65 years;
  * Reside in the sample county and plan to remain there throughout the study;
  * Normal baseline cognitive function or mild cognitive impairment (HMSE score \> 18);
  * Presence of uncorrected or inadequately corrected refractive error (i.e., distant vision \< 6/18 or near vision \< N6);
  * Able to accept random assignment and interventions, and willing to adhere to the study protocol;
  * Voluntarily sign an informed consent form to participate in the entire study process.

Exclusion Criteria:

* Age under 65 years;
* HMSE cognitive function score ≤ 18;
* Non-refractive visual decline (e.g., cataracts, glaucoma, or other severe ocular diseases);
* Severe mobility impairment requiring long-term bed rest or wheelchair use;
* Severe systemic diseases, including heart and liver failure, end-stage renal disease, malignancies, major neurological diseases, mental disorders, and/or other conditions that affect life expectancy or interfere with cognitive testing;
* Self-reported hearing impairment, unable to pass the whisper test;
* Use of hearing aids;
* Severe aging or end-of-life status.
Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF

Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor, cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors in the response to the treatment with anti-TNF in patients with rheumatoid arthritis after 24 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Over 18 years old
* Diagnosis of rheumatoid arthritis according to ACR criteria
* Patients that initiate treatment with anti-TNF drugs according to clinical practice, both in naïve anti-TNF patients and patients after first anti-TNF failure
* Patients able to follow the protocol requirements
* Patients that signed the informed consent

Exclusion Criteria:

* Patients with known hypersensitivity to investigational products
* Patients with tuberculosis, or severe infections like sepsis or opportunistic infections
* Patients with moderate/severe cardiac insufficiency (NHYA classification Class III/IV)
* Patients that according to the investigator criteria can not participate in the study or complete the study questionnaires
* Pregnant or fertile woman that does not use a contraception method
Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study

The aim of this prospective study is to explore the pain-alleviating effect of low-energy extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.

26 patients who suffered from persistent symptoms for more than 3 months are going to be treated with DOLORCLAST radial extracorporeal shock wave(EMS, Swiss). Patients are assigned to two groups according to the exist of specific pain spot. Group I(have specific pain spot) received a total of 2000 impulses of 2.5 Bar; group II(controls, no specific pain spot) 4000 impulses of 2.5 Bar. Patients is going to be treated once. The efficacy of therapy is going to be evaluated by VAS scale before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Symptom of low back pain during last 4 weeks
* Low back pain history for more than 3 months

Exclusion Criteria:

* Have lower limbs radiating pain beyond knee joints
* Spinal tumorous or infectious disease, fracture, ankylosing spondylitis, cauda equina syndrome or other severe spinal diseases
* Spinal surgical history
* Severe heart, lung, liver, kidney disease or high blood pressure
* With cardiac pacemaker
* Coagulopathy or thrombosis
* Have ESW therapy or pharmaceutical treatment for low back pain during last 1 months
* Mental illnesses or none cooperation
* Pregnancy
The Clinical Trial of Cefuroxime Axetil Dispersible Tablets

1. National, large-scale, standardized, standardized, real-world research;
2. Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
3. in the use of cefuroxime axetil dispersible tablets in the hospital, according to the principle of voluntary selection of 200;
4. registration of the use of cefuroxime axetil dispersion tablets patients;
5. Target sample size of 100,000 cases;
6. Exemption from informed consent for ethical review applications;
7. Antibiotic drug safety re-evaluation of large data.

Research purposes

1. To evaluate the safety of cefuroxime axetil dispersible tablets in the real world of the widely used population,

   Rare or even very rare, new, unanticipated adverse reactions, while revealing adverse reactions

   Should be susceptible to risk factors and susceptible populations.
2. To evaluate the efficacy of cefuroxime axetil dispersible tablets in the treatment of the relevant site of infection, including

   Including empirical therapy and targeted therapy, to further evaluate the widespread use of cefuroxime dispersible tablets

   The validity of the crowd in the real world.
3. To investigate the clinical application of cefuroxime axetil dispersible tablets for the safety management of drug use.

   Clinical management should provide more clinical clues and basis.
4. For the relevant treatment areas of guidance and consensus revision, clinical pathway design provides a reference.
5. To further improve the safety of cefuroxime axetil dispersion tablets level, the basic medical security capabilities and Market vitality.

Study end point

1. The main study endpoint:

   * Security;
   * Effectiveness.
2. Secondary study endpoint:

   * Extensive use of population characteristics;
   * Clinical drug characteristics;
   * Appropriate characteristics of the crowd;
   * Adverse reactions susceptible population characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Prescription of cefuroxime axetil dispersible tablets in patients

Exclusion Criteria:

* no
Methylation Status of CD44 Promoter Region in Primary Lung Cancer

This project is to study the methylation status of the transcriptional regulatory region of CD44 gene in surgically resected NSCLC specimens and normal lung tissue, correlate the methylation status of promoter region with the expression of CD44 gene, and analyze if methylation is associated with survival.

CD44 is a cell surface receptor for the extracellular matrix hyaluronan. It mediates adhesion of cells to the extracellular matrix. Its ability to organize extracellular matrix into a medium is also used by cancer cells in their becoming metastatic. Invasive tumor cells are frequently observed to bind hyaluronate.

CD44 gene is made up of 20 exons, at least 10 of which are variably expressed due to alternative splicing of the mRNA. The standard form, CD44s, has a coding sequence of exons 1-5 and 16-20. Variant isoforms (CD44v), all larger, arise from alternative splicing of combinations of exons 6-15 (v1-10). A variant isoform CD44 can induce metastasis of a rat pancreatic carcinoma. Studies in human tumors, however, have produced variable results. Some breast cancers demonstrate positive correlation between CD44v expression and tumor progression, while others lack any correlation. Some colorectal tumors even show an inverse correlation. CD44 has also been demonstrated to be a metastasis suppressor gene for prostate cancer. Thus, CD44 may be a marker for metastasis for some tumors, but not for others, and it may actually be a metastasis suppressor gene for yet another groups of tumors.

For primary lung cancer, the correlation between CD44 expression and tumor metastasis has not been established. The metastasis-prone small cell lung cancer rarely showed any immunohistochemical staining for CD44s or CD44v. For non-small cell lung cancer (NSCLC), some studies showed positive correlation between immunohistochemical CD44v expression and tumor progression, while others showed no correlation. Our own study using RT-PCR, sequencing and immunohistochemical staining showed that in pulmonary adenocarcinoma, CD44v6 expression is down-regulated as the disease progressed. Based on our finding, and the observation that CD44s and CD44v expression are low in metastasis-prone small cell lung cancer, we assue that CD44 is a metastasis suppressor gene which is inactivated in lung cancers. Because in prostate cancer DNA hypermethylation has been shown to be related to the down-regulation of CD44 gene, we plan to study the methylation status of the transcriptional regulatory region of CD44 gene in primary lung cancer. We'll study CD44 expression by immunohistochemistry, the methylation status of CD44 regulatory region by sequencing of the bisulfite-modified genomic DNA, and correlate these two findings with each other, and with histologic type, tumor staging and survival.

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer

Exclusion Criteria:

* No
Pediatric Tonsillectomy Pain Reduction Study

Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).

Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. Previous studies in the pediatric population have demonstrated a significant decrease in post-operative pain/morbidity when administering pain reduction medications into the tonsillar fossa prior to removal. While these studies have shown great promise, no large randomized trial of the most promising medications has been conducted. Because of this, many otolaryngologists do not administer intra-operative medications aimed at reducing post-operative pain. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).

Eligibility Criteria:
Inclusion Criteria:

* Age 3 - 17 years old
* BMI \< 35
* Negative pregnancy test in female patients age 10 and older
* Diagnosed with adenotonsillar hypertrophy, recurrent adenotonsillitis or upper airway obstruction and will be undergoing tonsillectomy alone or adenotonsillectomy

Exclusion Criteria:

* Diagnosis of obstructive sleep apnea
* Patient with peritonsillar abscess
* Allergy to study medication
* Any major systemic illness, genetic disorder or diagnosed syndrome
* Bleeding disorder