cyrilzakka/clinical-trials huggingface dataset:
Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR TID and Pelubiprofen SR (as a Pelubiprofen 90 mg) Tablet QD in Healthy Subjects

A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Adult Healthy males aged 20\~45 years
2. weight over 45 kg, ideal body weight ±20%\[Ideal weight\] = \[Height(cm)-100\] X 0.9
3. Subjects who voluntarily agreed with written consent

Exclusion Criteria:

1. Patients with acute disorder within 28 days before clinical trial drugs administration
2. History of disorders(inflammatory GI tract disease, stomach ulcer, gastrectomy, liver disease) which can affect ADME of drugs
3. Patients with active GI tract, cardiovascular, respiratory, renal, endocrinal, haematological, central nerval, psychiatric disease or malignant tumor
Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination

This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to older adults at risk for cardiovascular outcomes. The hypothesis is that assigning care coordinators to older adults based on perceived need will be more effective at preventing emergency department visits and hospitalizations compared to usual care.

This project will use a pragmatic clinical trial embedded in an accountable care organization (ACO) to determine the comparative effectiveness of two different approaches for selecting older adults at risk for cardiovascular outcomes to receive support from care coordinators: (1) an approach that assigns older adults to care coordinators based on self-reported difficulty with care coordination, or (2) usual care, which generally assigns older adults to care coordinators after hospital discharge, regardless of perceived need. The investigators will include community-dwelling Medicare beneficiaries ≥65 years old with cardiovascular disease (CVD) or 1 or more CVD risk factors who have been attributed to the NewYork Quality Care ACO and who have fragmented care. The investigators will randomize the participants into two groups. This study is highly pragmatic, and the intervention is sustainable and scalable. Moreover, the proposed approach has the potential to improve care delivery and outcomes for older adults at risk for cardiovascular outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Medicare beneficiaries 65 years and older,
* Attributed to the NewYork Quality Care accountable care organization,
* Are community-dwelling,
* Have cardiovascular disease or 1 or more cardiovascular risk factors, and
* Had highly fragmented ambulatory care in the prior year (defined as a reversed Bice-Boxerman Index greater than or equal to 0.85)

Exclusion Criteria:

* Those who reside in long-term care or nursing home facilities (based on addresses in Medicare claims)
* Enrolled in home hospice
* Dementia (as measured in claims using the Bynum Standard 1-year definition)
Dietary Intake and Circulating Levels of Branched Chain Amino Acids

The investigators are conducting this research study to find out if eating low or high levels of specific amino acids changes the levels of these same amino acids in the blood. Amino acids are the building blocks of protein that are normally found in food. The amino acids the investigators are studying are called branched chain amino acids. The investigators will look at the levels (amount) of branched chain amino acids in blood before and after consumption of specially prepared meals. The investigators hypothesize that circulating branch chain amino acid (BCAA) levels will be lower following a low BCAA-content diet compared with a high BCAA-content diet.


Eligibility Criteria:
Inclusion Criteria:

* Adult males
* Ages 20-40
* Healthy

Exclusion Criteria:

* Age less than 20 or greater than 40
* Female sex
* Use of medications and herbal or vitamin supplements during the study or less than one month prior to enrollment in the study
* Body mass index (BMI) less than 20 or greater than 25
* Changes of more than 5 pounds in weight (increase or decrease) during the month prior to enrollment in the study
* Participation in more than 300 minutes of exercise per week during the month prior to enrollment in the study or plans for changes in exercise level during the study
* Known diabetes or pre-diabetes (based on prior diagnoses; use of medications to lower glucose; or fasting blood glucose \> 100mg/dL at screening)
* Untreated hypertension (defined as systolic blood pressure \> 140mmHg and diastolic blood pressure \> 90mmHg)
* Use of nicotine-containing products, including those inhaled, chewed, or patches during the study.
* Use of drugs of abuse.
* Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric surgery
* Restrictions that prevent adherence to standardized meals or unwillingness to adhere to a pre-specified meal plan, including abstinence from alcohol and limitation to 1 caffeinated beverage per day
* Known anemia (men, hematocrit \< 38%) based on prior testing
Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema

The project aims to compare the differences in the expression of cell death through apoptosis and iron-dependent cell death after the reduction of edema symptoms following lymphedema surgery in patients.

This project aims to investigate the expression of cell death through apoptosis and iron-dependent cell death in the subcutaneous adipose tissue of patients with lymphedema. The study also seeks to explore the roles of these processes among lymphatic endothelial cells, adipocytes, and macrophages, and their association with lymphedema, thus gaining insights into the pathophysiological mechanisms of lymphedema. Furthermore, the project aims to compare the differences in the expression of cell death through apoptosis and iron-dependent cell death after the reduction of edema symptoms following lymphedema surgery in patients.

Eligibility Criteria:
Inclusion Criteria:

* Control Group: Patients who have not experienced lymphedema but require surgery due to other diseases such as cancer, trauma, chronic wounds, skin defects, etc.
* Experimental Group: Patients who have lymphedema and undergone lymphedema surgery.

Exclusion Criteria:

* 1. Individuals with venous thrombosis, chronic heart failure, and renal failure.
* 2. Vulnerable populations, individuals with limited mobility, pregnant women, and minors.
* 3. Those expected to be unable to attend follow-up visits or complete the study smoothly.
* 4. Participants who express doubts about the trial and cannot provide satisfactory answers.
Effect of Dexmedetomidine on Postoperative Cognitive Function in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position Under Desflurane Anesthesia

Investigate the effects of dexmedetomidine on postoperative cognitive function in patients undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing shoulder arthroscopic surgery with beach chair position

Exclusion Criteria:

1. Patients with respiratory disease
2. Patients with cardiac disease
3. Patients with cerebrovascular disease
4. patients with uncontrolled hypertension
5. Patients with dementia
6. Patients with psychiatric disease
Serum Omentin-1 and Carotid Atherosclerosis In Non-Diabetic Chronic Kidney Disease

The aim of the study is to evaluate whether a low level of serum omentin-1 is associated with carotid atherosclerosis and mediated by inflammation.

Atherosclerotic cardiovascular disease is markedly increased in chronic kidney disease. There are a lot of risk factor, along with conventional risk factors. Serum onemtin-1 is a adipokine and suggested as a new marker for vascular disease.It has some anti-atherogenic properties. Studies investigating serum omentin-1 level have usually conducted in patients with diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* between ages of 18 - 65 years old chronic kidney disease of stage 3-4

Exclusion Criteria:

* Chronic kidney disease of stage 5
* The history of ischemic cardiovascular disease (myocardial infarction, unstable angina, stroke, peripheral artery disease, or cardiovascular revascularization)
* Severe heart failure
* Stage 2 hypertension
* Diabetes mellitus
* Corticosteroid therapy
* Severe hepatic disease
* Smoking
* Inflammatory disease
* Acute infectious disease
* Malignancy
Motivational Interviewing With Diabetes Patients

This study was conducted in a quasi-experimental research design with a pretest-posttest control group to determine the effect of motivational interviewing on self-management and HbA1c in patients with type 2 diabetes. The sample of the study consisted of 25 experimental and 26 controls, who applied to an outpatient clinic in a training and research hospital.

This study was conducted in a quasi-experimental research design with a pretest-posttest control group to determine the effect of motivational interviewing on self-management and HbA1c in patients with type 2 diabetes. The sample of the study consisted of 25 experimental and 26 controls, who applied to an outpatient clinic in a training and research hospital. After the pretest, the experimental group was intervened with a motivational interview (MI) method that consisted of four sessions; the control group received routine treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Having been diagnosed with type 2 diabetes for more than 3 months
* Being in the contemplation
* Preparation, and/or action stages of any section of the Behavioral Change Stage Identification Form of the Trans-Theoretical Model
* Having HbA1c levels above 6
* Agreeing to take part in the study

Exclusion Criteria:

* Having a perception disorder that will prevent communication
* Having been diagnosed with any mental disorder
A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants

This 2-part study will evaluate the effect of coadministration of a Cytochrome P450, family 3, subfamily A (CYP3A) inhibitor, itraconazole (Part 1), and a high-fat/high-calorie meal and a modified gastric pH (Part 2), on the single dose drug levels of BMS-986368 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m\^2) to 33.0 kg/m\^2, inclusive.

Exclusion Criteria:

* Personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Situational depression, or anxiety in the past, may be enrolled at the discretion of the investigator.
* Participant has an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
* Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1.

Other protocol-defined inclusion/exclusion criteria apply.
Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality

Prostate cancer is the most common cancer in France (54,000 cases in 2011). About 20,000 radical prostatectomies (PR) per year are performed. Despite the progress of PR over the past 20 years, the rate of erectile dysfunction post PR varies between 30 and 90% and only 16% of operated men recover their pre-treatment erections.

There is currently no validated post-prostatectomy rehabilitation protocol. The associations of patients, including the National Association of Prostate Cancer Patients have a very strong demand for treatment of sexual problems after treatment.


Eligibility Criteria:
Inclusion Criteria:

Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot:

* Aged over 18
* presenting a cancerous pathology of the prostate having an indication of radical prostatectomy with or without preservation of the neurovascular strips.
* affiliated to a social security scheme.
* and having been informed and given informed consent to participation in the program.

Exclusion Criteria:

* Refusal of participation, signature of consent,
* protected major patients, under guardianship or curators.
* Patients unable to understand the course of the study
* Patient with a documented history of cognitive or psychiatric disorders.
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine

The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella.


Eligibility Criteria:
Inclusion Criteria:

* Aged 12-13 months on the day of inclusion
* Born at full term of pregnancy (\>37 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by the parent(s) or other legal representative
* Able to attend all scheduled visits and to comply with all trial procedures
* Subjects having received only one or no injection of vaccine against Measles
* Subjects anti-HAV seronegative according to the results obtained at the screening visit\*

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received in the past 3 months
* Any vaccination in the 4 weeks preceding the first trial vaccination
* Vaccination planned in the 4 weeks following any trial vaccination
* History of hepatitis A, Mumps, Measles and/or Rubella infection (confirmed either clinically, serologically or microbiologically)
* Previous vaccination against hepatitis A with the trial vaccine or another vaccine
* Previous vaccination against Mumps, Measles and Rubella with a Mumps, Measles and Rubella trivalent combined vaccine
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of seizures
* Febrile illness (axillary temperature ≥37.4°C\]) on the day of inclusion
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Histologically or cytologically confirmed advanced solid tumors

  * Arm #1 (Monotherapy): HRAS-mutant and/or amplified tumors (any solid tumor type); HRAS overexpression (only for HNSCC tumors); KRAS and/or NRAS, and/or HRAS-mutant and/or amplified NSCLC or CRC; KRAS-mutant and/or amplified PDAC
  * Arm #2 (Combination): Must have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC
  * Arm #3 (Combination): Must have KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC and have received at least 1 prior systemic therapy for advanced or metastatic disease
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Karnofsky Performance Status of 70 or higher with no clinically significant deterioration over the previous 2 weeks.
* Acceptable liver, renal, endocrine, and hematologic function.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Ongoing treatment with certain anticancer agents.
* Prior treatment with an FTI or HRAS inhibitor.
* Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery.
* Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.
* Toxicity (excluding alopecia) from prior therapy that has not been completely resolved to baseline at the time of consent.
* Active or prior documented autoimmune or inflammatory disorders within the past 5 years prior to Cycle 1 Day 1 (with exceptions).
* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
* Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs.
* Inadequate cardiac and/or vascular function, including receipt of treatment for unstable angina, myocardial infarction, and/or cerebro-vascular attack within the prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure.
* Other invasive malignancy within 2 years.
* Other protocol-defined exclusion criteria may apply.
A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants

This is a cohort study to understand the changes of breastmilk composition in the first six months after birth of Chinese infants.

The relationship of breastmilk composition, the maternal gut microbiome and lifestyle factors such as diet, feeding practices and physical activity and the infant's health and gut microbiome will be investigated in this study.

Eligibility Criteria:
Inclusion Criteria:

Mothers:

1. Generally healthy mothers with the intention to breastfeed.
2. Aged 18 years and above.
3. Written informed consent.

Infants:

1. Generally healthy term born (gestational age between 37 and 42 weeks).
2. Breastfed by their mothers, either exclusively or in combination with infant milk formula, at enrolment.
3. Chinese ethnicity of mother and father.

Exclusion Criteria:

Mothers:

1. Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
2. Difficulty to follow up and/or locate (e.g. known transfer to other hospitals, residing outside the city where the study site is located, or planning to move out of the current city; incapability of mothers to comply with study protocol or investigator' s uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements.
3. Illegal drug use.
4. Regular smoking and/ or consumption of alcoholic beverages as per investigator's judgement.
5. A BMI of \<18.5 or ≥ 28 pre-pregnancy or during the first regular pregnancy check around or before 16 weeks of gestational age.
6. Acute infectious disease or neoplastic disease or any kind of weakening or debilitating conditions (with history of positive, hepatitis C virus (HCV) or HIV serological test at any time during the pregnancy).
7. Presence of mastitis, fungal infections of the nipple or areola; reactivation of herpes simplex (HSV) or varicella zoster infection in the mammary or thoracic region at the time of enrolment.
8. Presence of chronic diseases such as endocrine, cardiovascular, renal, respiratory or hepatic diseases.
9. Presence of psychosis and severe post-partum depression.
10. Presence of autoimmune disease such as systemic lupus erythematosus, systemic scleroderma, ulcerative colitis, Crohn's disease, celiac disease.
11. Women whose health condition, according to the investigator's judgement, could interfere with the study conduction and assessment.
12. Mothers who have given birth to twins or multiples or infant conceived with Assisted Reproductive Technology (ART).

Infants:

1. Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
2. At enrolment, any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.
3. Consumption of food other than breast milk or infant formula.
4. Fully formula fed at enrolment.
The Factors Associated 30-day Mortality After Perioperative Cardiac Arrest in Adults Undergoing Non-cardiac Surgery.

Perioperative cardiac arrest (PCA) in patients undergoing noncardiac surgery is a rare but potentially catastrophic event associated with high mortality. Several studies have highlighted the factors contributing to PCA in the surgical population. However, information on outcomes after PCA among the surgical population is still limited. Our study aims to identify the incidence of PCA, 30-days mortality and the factors associated with PCA and 30-day mortality after PCA in adults undergoing non-cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* patients aged\> 18 years old
* history of perioperative cardiac arrest
* non- cardiac surgery

Exclusion Criteria:

* did not receive cardiopulmonary resuscitation (CPR) during PCA
* incomplete data regarding 30-day mortality were excluded
A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections

This clinical trial tests the hypothesis that body decolonization of patients with recurrent community-associated (CA) MRSA infections will significantly reduce the likelihood of recurrent CA-MRSA infection.

Staphylococcus aureus is a ubiquitous pathogen, and causes infections of the skin, lung, bloodstream, and other body parts. Over the past decade,community-acquired methicillin resistant S. aureus (CA-MRSA) infections, which were previously extremely rare, are occurring commonly worldwide. CA-MRSA is the most common cause of skin infection in many locales in the U.S.

CA-MRSA strains are notable for their ability to spread in closed settings and cause recurrent infections among healthy persons. Management of recurrent CA-MRSA infection is challenging and optimal prevention strategies are undefined. Many experts recommend topical agents that decontaminate the body and/or anterior nares. However, there are no data that quantify the efficacy and safety of this approach.

We conducted a prospective non-comparative clinical trial to quantify the efficacy and safety of body decolonization regimens in the prevention of CA-MRSA infection from an Infectious Diseases private practice group in Northern California.

The study population comprised of persons suffering from recurrent CA-MRSA infection. For this clinical trial, all subjects will be given: nasal mupirocin (Bactroban Nasal, twice daily), topical 3% hexachlorophene body wash (Phisohex, daily), and an oral anti-MRSA antibiotic. The choice of oral antibiotic was based on investigators choice and antibiotic susceptibility of prior MRSA isolates in a given patient.

Patients were interviewed in person baseline and by phone at 2 weeks, 3 months, and 6 months using a standardized questionnaire. The baseline survey, based on a previously developed instrument used for an epidemiologic investigation of MRSA asked about MRSA risk factors and health-related quality of life. Follow up surveys asked about adverse drug effects, especially gastrointestinal and dermatologic side effects (2 week visit only) and incident skin and MRSA infections.

Eligibility Criteria:
Inclusion Criteria: recurrent MRSA infections and had greater than or equal to 2 MRSA infections in the 6 months prior to enrollment