cyrilzakka/clinical-trials huggingface dataset:
Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects

To compare the pharmacokinetics, pharmacodynamics and safety/tolerability of LC51-0255 film-coated tablet (SG85) with LC51-0255 uncoated tablet (SG82) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females between the age of 19 and 45 at the screening visit
2. Subjects with the Body Mass Index (BMI) measurement results between 18.0 kg/m2 and 27.0 kg/m2 at the screening visit
3. Subjects who were confirmed to be healthy based on the medical history
4. Subjects who make a voluntary decision to participate in this clinical study and provide the informed consent

Exclusion Criteria:

1. Subjects with a clinically significant disease or history in liver, kidney, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system or cardiovascular system
2. Subjects with a disease (e.g., Crohn's disease, etc.) or history of surgery (except for simple appendectomy and herniotomy) in gastrointestinal system which may affect the absorption of the investigational product
3. Subjects with a history of clinically significant disease or suspicious sign/symptom of ophthalmologic disease including uveitis and retinitis at the screening visit
4. Subjects who had donated whole blood within 2 months, component blood within 1 month, or received transfusion within 1 month prior to the first administration day
5. Subjects who had taken an inducer or inhibitor of drug metabolism such as barbiturates etc. within 1 month prior to the first administration day
6. Subjects who had eaten grapefruit/caffeine-containing food within 3 days prior to the first hospitalization or subjects who could not stop taking food containing grapefruit or caffeine from 3 days prior to hospitalization to the discharge day
7. Subjects who had taken any prescription drug or herbal medicine within 2 weeks or any over the counter (OTC) drug within 1 week prior to the first administration day (however, subjects fulfilling other conditions could participate in the study at the investigator's discretion)
8. Subjects who taking excessive caffeine or alcohol or heavy smoker (caffeine \> 5 units/day, alcohol \> 21 units/week (1 unit = 10 mL as pure alcohol), smoking \> 10 cigarettes/day)
9. Subjects who had a history of tuberculosis (TB) infection or a positive result in the Quantiferon TB-Gold test and the chest X-ray in the screening tests
10. Subjects who unable to take the food provided by the study institution
11. Subjects who with a positive result in the serology test (hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test, syphilis test)
12. Other cases that the investigator consider unsuitable as the subject
International Ledless Pacemaker Registry

The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers.

The aim of this multi-center study is to assess the clinical outcomes of patients implanted with Micra LLPM in real life, in different clinical scenarios.

The study includes consecutive patients implanted with a pacemaker leadless device (Micra Transcatheter Pacing System; Medtronic, Inc., Minneapolis, MN, USA).

Baselines characteristics, procedural and clinical outcomes will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria: All patients implanted with the MIcra leadless pacing system

* At least 1 month of follow up
* At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center

Exclusion Criteria:

* None
Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts

Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast.

Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast. Values obtained at the biopsy site will be compared against the outcome of the biopsy analysis: benign vs. malignant. In addition the measurements obtained at the standardized site for all breasts will be used to establish a set of reference values to characterize breast TDC values. In addition, inter-breast differentials will be used to characterize these ranges for future studies and clinical assessments.

Eligibility Criteria:
Inclusion Criteria:

* You must be scheduled for a breast biopsy of a breast mass or abnormality with the collaborating centers

Exclusion Criteria:

* You have any open wounds over the breasts
* You have had breast cancer
* You have or have had breast implants or have undergone any breast surgery or breast biopsy
* You have any implantable wires, this includes a Pacemaker, Implantable Cardioverter ° Defibrillators (ICDs), and/or Left Ventricular Assist Device (LVAD)
* You are pregnant
Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)

This open-label study will evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blind, adaptive study 'A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)(RIN-PH-304).

This is a multi-center, open-label study for eligible participants who completed all scheduled study visits during the Treatment Period of Study RIN-PH-304.

Participants who provide informed consent for this open-label extension study on or prior to the final study visit of RIN-PH-304 may participate in the study, provided all other eligibility criteria are met. The RIN-PH-304 final study visit and the RIN-PH-305 Enrollment Visit will occur on the same day.

All participants will reinitiate inhaled treprostinil at 3 breathes (18 micrograms \[mcg\]) 4 times daily (QID) during waking hours. Study drug doses should be maximized to tolerability throughout the study, and dose titrations should occur as rapidly as possible (as directed by the Investigator) with a target dosing regimen of 15 breaths QID or the maximum tolerated dose.

Eligibility Criteria:
Inclusion Criteria:

1. Participant voluntarily gives informed consent to participate in the study.
2. Participant completed Study RIN-PH-304.
3. Women of childbearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must agree to practice abstinence or use 2 highly effective methods of contraception (defined as a method of birth control that results in a low failure rate, \[less than 1% per year\], such as approved hormonal contraceptives, barrier methods \[such as condom or diaphragm\] used with a spermicide, or an intrauterine device) for the duration of study treatment and for 48 hours after discontinuing study drug.
4. Males with a partner of childbearing potential must agree to use a barrier method (condom) with a spermicide for the duration of treatment and for at least 48 hours after discontinuing study drug.

Exclusion Criteria:

1. The participant is pregnant or lactating.
2. The participant was prematurely discontinued from Study RIN-PH-304.
3. The participant is intolerant to inhaled prostanoid therapy.
4. The participant is unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device).
5. The participant is scheduled to receive another investigational drug, device, or therapy during the course of this study.
6. Any other clinically significant illness or abnormal laboratory value(s) that, in the opinion of the Investigator, might adversely affect the interpretation of the study data.
Westlake Longevity Cohort

The Westlake Longevity Cohort (We-Longevity) is a prospective cohort study among centenarians, nonagenarians and senior citizens living in Lishui, China. The primary aim of this cohort is to characterize the multi-omics molecular characteristics of healthy longevity and their dynamic trajectories. Another aim of We-Longevity is to investigate the association of dietary and lifestyle with the multi-omics molecular characteristics of healthy longevity, and to facilitate the development of personalized nutritional/lifestyle recommendation for the public.

Aging is a major risk factor for most fatal diseases, such as Alzheimer's disease, type 2 diabetes, cardiovascular disease and cancer. Global population aging is becoming increasingly serious, and this trend is mainly driving the annual increase in the prevalence of aging-related diseases. Healthy longevity are influenced by a variety of factors, such as diet structure, lifestyle, ecological environment, gut microbiome and genetics. At present, the researches on healthy longevity are mainly focused on Drosophila, nematodes and mouse models, and few studies on longevity population. Centenarians and nonagenarians are the best objects to study healthy longevity. However, the multi-omics molecular characteristics and regulatory mechanism of healthy longevity in human are still unclear. There, the present We-Longevity design includes centenarians, nonagenarians, and senior citizens. We will determine the fecal/serum metabolome, gut microbiome serum proteome and genome, together with diet, lifestyle and disease information.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 50 years or order.
* Participants live in Lishui, China.
* Participants intend to remain in Lishui for ≥3 years.

Exclusion Criteria:

* Participants with cancer, serious medical disorders or infectious diseases.
Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter

The aim of this randomized study was to assess the effectiveness of endomyocardial botulinum toxin injection for preventing post-procedural atrial fibrillation in patients undergoing the radiofrequency ablation of atrial flutter.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ECG documented paroxysmal or persistent AFL
* No prior documented history of AF
* Patient undergoing RFA of AFL.
* No indication (other than AFL) for continued anticoagulation with warfarin.
* No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device)

Exclusion Criteria:

* A history of atrial fibrillation
* Previous AF ablation procedure
* Congestive heart failure
* Left Ventricle ejection fraction less than 35%
* Unwillingness to participate
Prospective Evaluation of a Comprehensive Smoke-Free Public Housing Policy in a Multi-State Setting

The primary objective of this project is to evaluate the effectiveness of an enhanced intervention vs. a standard intervention to complement a comprehensive smoke-free policy, in a multi-site, privately managed affordable housing context.

Beacon Communities, a private property management company, is unveiling a comprehensive smoking ban at all 52 of its properties. A multi-component, "enhanced" intervention designed to promote, strengthen, and maintain a smoke-free policy across public housing developments will be implemented prior to commencement of the smoke-free policy. The enhanced intervention will be tested against a standard intervention of educational materials and information on cessation options. This study will be open to residents at 12 Beacon Communities properties at which a Resident Service Coordinator (RSC) is located.

The primary objective of this project is to evaluate the effectiveness of enhanced intervention vs. standard intervention to support a comprehensive smoke-free policy, in a multi-site, privately managed affordable housing context. A further objective is to develop a toolkit of strategies for the large-scale implementation and maintenance of a smoke-free policy in multi-unit affordable housing developments. The toolkit will be the first to be developed directly from an extensive two-stage qualitative analysis and will apply the lessons learned in this study to provide a sustainable resource for property managers seeking to implement smoke-free policies.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over
* Able to speak English or Spanish
* A resident of Beacon Communities housing development (12 selected sites)
* Thinks that he/she will be living in his/her Beacon Community for at least the next 12 months

For Smokers:

* Have smoked cigarettes or e-cigarettes in the last week

For Non-Smokers:

* Self-reported exposure to secondhand smoke in the previous 2 months

Exclusion Criteria:

* Have another household member enrolled in the study
A Study in the US Based on Pharmacy and Medical Claims That Compares How Well Stiolto® and Trelegy® Work in People With Chronic Obstructive Pulmonary Disease (COPD)

This study looks at data from people with chronic obstructive pulmonary disease (COPD). Some used Stiolto Respimat and the others Trelegy Ellipta as their first treatment for COPD.

The purpose of this study is to find out how well the treatments worked. Researchers compare the time to first COPD flare-up (exacerbation) between the 2 treatments.

The study analyses anonymous data from pharmacy claims collected over 3.5 years.


Eligibility Criteria:
Inclusion Criteria:

* ≥40 years of age as of the year of the index date
* At least one pharmacy claim for Stiolto Respimat or Trelegy Ellipta.

  * For Stiolto Respimat users, the first pharmacy claim of Fixed Dose Combination (FDC) of Tiotropium + Olodaterol (5/5 micrograms (mcg)) will be defined as the index date.
  * For Trelegy Ellipta users, the first pharmacy claim of FDC of Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg), will be defined as the index date.
* Two medical claims (at least one claim on index date or before in the baseline period) with an International Statistical Classification of Diseases and Related Health Problems (ICD)-9/10 diagnosis code(s) for chronic obstructive pulmonary disease (COPD) in any position during the study period (baseline ± post index date).
* At least one year of continuous medical and pharmacy health plan eligibility prior to the index date is required (to allow a baseline period for the covariates and characterizing the study population).

Exclusion Criteria:

* To increase the likelihood of a true diagnosis of COPD, we will exclude all patients with two medical claims of asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the study period.
* To restrict the cohort to first line maintenance therapy of Stiolto Respimat or first line maintenance therapy of Trelegy Ellipta we will exclude: patients on long-acting muscarinic antagonists (LAMA) monotherapy; long-acting beta2 agonists (LABA) monotherapy; inhaled corticosteroids (ICS) monotherapy; free or FDC of: ICS+LABA, LAMA+LABA, ICS+LABA+LAMA therapy within six months prior to index date.
* Pharmacy claims for multiple index medications on the index date.
* Pharmacy claims for non-index COPD maintenance medications on the index date.
Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus

obese male usually complain subjective tinnitus that may affect their sexual function.

this study will enroll forty obese males with subjective tinnitus (bilateral complaint) and sexual dysfunction (erectile dysfunction) who will be divided to group I and group II with an equal number of males within each group (n =20 for the group). all male in both groups will administer low calorie diet for 12 weeks but Group I will additionally administer supervised walking training aerobic training for 45 minutes 3 times per week for 12 weeks).

Eligibility Criteria:
Inclusion Criteria:

* obese person
* body mass index less than 40 kg/m2 and more than 30 kg/m2
* males with subjective tinnitus (bilateral presentation from at least 24 weeks).
* males with sexual dysfunction (erectile dysfunction from at least 24 weeks)

Exclusion Criteria:

* cardiac diseased males
* respiratory diseased males
* hepatic, musculoskeletal, and hepatic diseased males
* diabetic males
Antibiotic Treatment Duration (7 vs 14 Days) Comparison in Blood Stream Infection Causes by Enterobacteriaceae

The antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria are becoming more and more frequent, and available antimicrobial agents are usually scarce. Reducing the duration of antimicrobial treatments is one of the most efficient measures to control the antibiotic pressure and to optimise the use of these agents.

Bloodstream infections produced by Enterobacteria (EB) are very frequent, but the optimal duration of antibiotics to treat them is unknown, as long as no clinical trials have been specifically developed to answer this question.

Basing on expert opinions, the Infectious Diseases Society pf America (IDSA) recommends the bacteremia by EB secondary to vascular catheter infections to be treated for 7 to 14 days. This represents a variability of up to 100%. No recommendations have been published regarding the duration of treatment of bacteremia from other sources.

The objective of this project is to prove that the 7-day course of treatment for EB bacteremia is more efficient and equally safe than the 14-day scheme.

To achieve theses objectives, we propose this randomized, multicentric clinical trial with a superiority design on the duration of antimicrobial treatment for EB bacteremia in adult patients.

Eligibility Criteria:
Inclusion criteria:

* Adults patients (equal or over 18 years old)
* Primary or secondary bloodstream infection produced by enterobacteriaceae
* Source of bacteremia properly controlled or expect to be properly controlled in the next 24 hours (i.e. bacteremia produced by infected vascular catheter, abscess, obstruction of the biliary or urinary tract).
* Patients able to understand the objectives of the clinical trial and informed consent signed.

Exclusion Criteria:

* Pregnancy
* Post-chemotherapy neutropenia expected to persist more than 7 days.
* Source of bacteremia uncontrolled at inclusion period or in the following 24 hours. The source will be considered as uncontrolled if the bacteremia is secondary to a suppurative infection potentially removable, if no action has been taken to eradicate it, including: bacteremia by vascular not removed catheter, cholangitis secondary to not derived obstruction of the biliary tract, deep abscess not drained, pyohydronephrosis without derivation of the urinary tract.
* Bacteremia secondary to infective endocarditis, bone and joint infections, or neurosurgical infections, which may require prolonged antimicrobial therapy
* Bacteremia due to enterobacteriaceae resistant to carbapenemics.
* Polymicrobial bacteremia including microorganisms different to enterobacteriaceae.
* Patients with no expectations of survival in the next 48 hours of inclusion.
Effects of Whole-body Vibration in the Frail Elderly

Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status, and its feasibility as an intervention in frail elderly patients.

Design: Randomized controlled trial. Subjects: The frail older persons meeting the Fried Frailty Criteria.

Interventions: All eligible subjects were randomly assigned to 4 groups:

(1) WBV group: Subjects received a whole-body vibration exercise alone; (2) Progressive resistance training (PRT) group: Subjects received progressive resistance training; (3) WBV+ PRT group: Subjects received the whole-body vibration and progressive resistance training; (4) Control group: Subjects received no intervention/training. The periods of intervention are 12 weeks.

Main measures: The lower extremities blood flow (the diameters and red blood cell velocity of the common femoral artery), timed up and go test, 30-second chair stand test, five times sit to stand test, lower extremities muscle strength, balance function, balance confidence, bone density, and general health status was assessed at the beginning of the study, at instant, 12 weeks and 24 month after the intervention.

Study hypothesis: Whole-body vibration exercise is a safe and effective method that can improve the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status in the frail elderly.


Eligibility Criteria:
Inclusion Criteria:

* ≥75 years old
* Fried Frailty Criteria
* Mini Mental State Examination score ≥18

Exclusion Criteria:

* Recent fractures (≤6 months)
* Gallbladder or kidney stones
* Malignancies
* Rheumatic arthritis
* Epilepsy
* Serious heart sicknesses or an implant, and bypass stent or cardiac pacemaker
* Any diseases to be associated with a life expectancy of less than 12 months
Exercise-based Telerehabilitation Program for Police Officers and Firefighters With Chronic Non-specific Low Back Pain

The aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.

Low back pain is the leading cause of year lived with disability worldwide. Workers exposed to physically demanding activities and inappropriate postures, such as those performed by police officers and firefighters, are highly affected by chronic low back pain. Smartphone app-based self-managed interventions have been shown to be an alternative for chronic non-specific low back pain treatment. However, there is still little research on the development and testing of remotely-delivered programs for the management of chronic low back pain, especially in police and fire professionals. The aim of this clinical trial is to develop and test the effectiveness of a smartphone app-based self-management program based on exercise and pain education for police officers and firefighters with chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 60 years
* Chronic low back pain (defined as pain lasting more than 12 weeks)
* Chronic low back pain of at least 3 points in a 0 to 10 Pain Numerical Rating Scale
* Own a smartphone with internet access and email account
* Police officer (federal, federal highway, civil or military) or military firefighter working in the State of Rio Grande do Sul

Exclusion Criteria:

* Present neurological symptoms (nerve root compromise, or sensation deficits)
* Present serious spinal diseases (e.g., fracture, tumor, inflammatory, autoimmune, and infectious diseases)
* Present serious cardiovascular and metabolic diseases (e.g., coronary heart disease, cardiac insufficiency, decompensated diabetes)
* Recent spine surgery (over the last 12 months) or scheduled to undergo surgery in the next six months, or pregnancy
* History of physical therapy treatment for low back pain or physical exercise (strength training for core muscles, Pilates, yoga) current or within the last 3 months
* Retired
* If have any contraindication to exercise:

We will perform a pre-screening for physical activity participation at baseline using the Physical Activity Readiness Questionnaire (PAR-Q) Portuguese version to rule out any contraindication to participate in physical activity