cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects

The purpose of this study is to evaluate the safety and tolerability of single and multiple oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects. This study will also evaluate the pharmacokinetics (PK) of ESN364 and its metabolite, and the pharmacodynamics (PD) of ESN364 after single and multiple oral doses administration in healthy Japanese male and pre- and post-menopausal female subjects.

This study consists of two parts. Part 1; Single Dose (SD) and Part 2; Single and Multiple Dose (SD and MD).

Eligibility Criteria:
Inclusion Criteria:

* Male subject between 20 to \< 45 years of age, or female subject between 20 to \< 65 years of age.
* Body weight at screening: ≥ 50.0 kg and \< 80.0 kg for male, ≥ 40.0 kg and \< 70.0 kg for female.
* Body mass index (BMI) at screening: range of ≥ 17.6 kg/m2 and \< 26.4 kg/m2 \[BMI = Body weight (kg) ÷ {Body height (m)2}\].

Exclusion Criteria:

* Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 84 days prior to screening.
* Subject has had previous exposure with ESN364.
* Subject has any clinically significant history of allergic conditions prior to study drug administration.
* Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy.
* Subject has contracted pyretic or symptomatic viral, bacterial, or fungal infection within 7 days prior to hospital admission.
* Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission.
* Subjects who has any significantly abnormal results of laboratory tests at screening or on the day of hospital admission.
* Subjects who are positive for any of urinary drug abuse test or serology test at screening.
* Subject took a drug or underwent therapy within 2 weeks prior to hospital admission.
* Subjects used a drug or underwent therapy that affects sex hormones within 3 months prior to hospital admission.
* Subjects who had bilateral orchiectomy.
* Subject has used any inducer of metabolism in the 3 months prior to hospital admission.
* Subject has a history of smoking more than 10 cigarettes per day within 3 months prior to screening test.
* Subject consumes, on average, more than approximately 500 mg/day of caffeine
* Subject has a history of consuming more than 30 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to screening.
* Subjects who conducted or is scheduled to conduct any blood donation or blood drawing.
Music Intervention on Golfers Under Mental Fatigue

This study aims to evaluate the effects of music intervention on golf-specific skill performance under mental fatigue. It is a randomised, controlled, double-blind design. The study consists of three main phases: familiarisation with the experimental procedure, baseline testing, and the formal experiment. During the formal experiment, participants will be randomly assigned to one of the following three groups: (MF-Mu Group) Participants undergo a mental fatigue induction task followed by a music intervention; (MF-nMu Group) Participants undergo a mental fatigue induction task but do not receive a music intervention; (CON Group) Participants neither undergo a mental fatigue induction task nor receive a music intervention. The total intervention duration is 45 minutes, consisting of 30 minutes of mental fatigue induction and 15 minutes of music intervention. In conditions where mental fatigue induction or music intervention is not conducted, participants will remain in the same experimental environment and rest quietly for the same duration to control for external confounding factors and ensure experimental consistency. Immediately after the intervention, participants will complete golf skill testing, with the testing site located within a 2 minutes walking distance from the intervention area. Performance outcomes include driving performance, iron shot performance, chipping performance, and putting performance.


Eligibility Criteria:
Inclusion Criteria:

* Athletes must be between 18 and 24 years old.
* Be registered golfers in the National Colleges and Universities Golf Championship.
* Have at least three years of specialised golf training.
* Engage in at least five weekly training sessions.

Exclusion Criteria:

* Colour blindness.
* Hearing loss.
* Insomnia.
* Physical injuries.
* Ongoing mental health issues.
* The use of any medication that might influence cognitive.
* The use of any medication that might influence physical performance.
Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)

The purpose of this study is to evaluate the prevention of cardiovascular disease by moderate cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.

It was already demonstrated by previous clinical trials that statins lower the incidence of death and cardiovascular events in patients with coronary artery disease. However, whether aggressive cholesterol lowering therapy, using high dosage of statins, is more effective than moderate cholesterol lowering therapy for the prevention of cardiovascular events in patients with coronary artery disease has not been studied in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Patients who met following all criteria are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration)
* Coronary artery disease patients meeting one of the following events

  * History of Acute Coronary Syndrome (AMI or Unstable angina)
  * History of revascularization (PCI or CABG)
  * Diagnosis of ischemic heart disease and coronary artery stenosis as having 75% or higher stenosis according to the AHA classification
* Hypercholesterolemia patients meeting one of following criteria

  * LDL-C is 140 mg/dL or over
  * LDL-C is 100 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians
  * Patents receiving cholesterol lowering drugs
* Age (≧20 \<80 year-old)
* Patients given written informed consent.

Exclusion Criteria:

Exclusion Criteria(Pre-Run-in period)

* Patients planning revascularization
* Malignant tumor in active phase
* Patients who meet contraindication of LIVALO tablet below

  * Patients who have hypersensitivity to LIVALO tablet
  * Patients who have severe liver dysfunction or biliary atresia
  * Patients who are being treated with cyclosporine
  * Pregnant women, women suspected of being pregnant, or lactating women
* Patients who have heart failure NYHA III or greater
* Patients undergoing dialysis
* Patients with familial hypercholesterolemia
* Patients registered in the other clinical trials
* Patients taking prohibited drugs
* Patients who are ineligible in the opinion of the investigator

Exclusion Criteria(Post-Run-in period)

* LDL-C is 120mg/dL or over after Run-in period
* Patients with occurrence of acute coronary syndrome (AMI or Unstable angina) within 3 months
* Patients who have been undergone PCI or CABG within 3 months
* Compliance is less than 50% in Run-in period
* Patients who met primary endpoint in Run-in period.
* Patients who met adverse events in Run-in period and judged as ineligible in the opinion of the investigator
* Patients who are ineligible in the opinion of the investigator
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

  * Smoking history of at least 10 pack-years
  * Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
  * Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

* Patients who have received systemic corticosteroids and/or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population

The purpose of this study is to evaluate the efficacy of an intravenous (IV) perioperative dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to opioid-based pain treatment following TKA. The study hopefully validates the use of a two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores in patients undergoing primary, unilateral TKA for osteoarthritis. One dose will be applied prior to incision and the other at post-operative day (POD) 1.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Hispanic self-identification
* Primary robotic-assisted TKA for treatment of primary osteoarthritis
* Age ≥ 21
* Receiving seven days of inpatient rehabilitation after medical discharge
* Patient with adequate glycemic control (HbA1c\<7.5%)
* Patients who provide written informed consent

Exclusion Criteria:

* Age ≤ 21
* Chronic steroid use prior to surgery
* Previous allergies or adverse reactions to steroid drugs
* Indications for surgery other than primary osteoarthritis
* History of narcotics abuse such as opioids
* Surgeries performed without robotic-assistance
* Outpatient or Home rehabilitation programs after medical discharge
* Requirement of revision surgery orthopaedic implants
* Patients with inadequate glycemic control (HbA1c≥7.5%)
* Other medical conditions, such as osteoporosis, fungal infections, glaucoma, joint infections, peptic ulcer disease which could worsen with steroid administration.
The Effect of Anti-CεmX on IgE Production

Despite the success of Omalizumab that neutralizes free IgE in blood and interstitial fluids, treatment of many allergic disorders remains an unmet medical need. Omalizumab was approved for patients having serum IgE levels in the range of 30-700 IU/ml. Omalizumab may not be effective for patients with much higher serum IgE levels, such as those with atopic dermatitis. Therefore, an alternative approach that targets IgE-committed B cells directly and inhibits the synthesis of IgE without binding to free IgE will be attractive. Anti-CεmX mAb, developed by Dr. TW Chang in Academia Sinica, binds human mIgE+ cells, including IgE-committed lymphoblasts and memory B cells. Such anti-CεmX mAbs should be able to activate B cell receptor (BCR) signaling, which leads to anergy or apoptosis of mIgE+ B lymphoblasts, and induces ADCC through their Fc portion. Depletion of mIgE+ B cells by anti-CεmX treatment would inhibit the formation of IgE-producing plasma cells, resulting in a long-term attenuation of IgE synthesis that would eventually lead to a desensitized state in allergic patients.

This study will collect blood from patients of high serum IgE levels to investigate the function of h4b12, a humanized mAb specific for mIgE+ B cells, and compare the effects of h4B12, Omalizumab, and Rituxumab on the suppression of IgE production and the number of IgE-producing plasma cells. These blood specimens will be collected from 50 patients of atopic dermatitis or urticaria with high serum IgE levels. Fountain Biopharma will carry out the following two in vitro assays to measure the efficacy of h4B12:

* IgE ELISA to determine the concentration of IgE.
* IgE ELISPOTto determine the number of IgE-producing plasma cells.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged ≥ 18 years
* Clinical diagnosis of atopic dermatitis or chronic urticaria

Exclusion Criteria:

-
Coffee Consumption and Pregnancy

Coffee, tea, and cocoa contain caffeine, a plant alkaloid. They are frequently consumed during pregnancy. We examined the effect of coffee consumption on fetal renal artery blood flow and amniotic fluid index (AFI) in the third trimester of pregnancy

This cross-sectional study occurred in a tertiary center with volunteer pregnant women who agreed to drink coffee. In healthy pregnant women with isolated borderline oligohydramnios, AFI and fetal renal artery blood flow indices were evaluated before and after coffee consumption. Sixty three patients for the borderline oligohydramnios group (the study group) were included in this study. These patients were compared with 63 healthy pregnant women who had normal amniotic fluid volume (the control group)

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with a singleton, uncomplicated pregnancy between the 34th and 37th weeks of gestation were included in this study during routine antenatal examinations

Exclusion Criteria:

* abnormal amniotic fluid volume (AFV), any intake of nutrient or fluid within the 4 hours previous to ultrasonographic examination \[10\], abnormal Doppler blood flow, hypertension, preeclampsia, chromosomal anomaly, intrauterine growth restriction, fetal anomaly, collagen vascular disease, ruptured fetal membranes, and multiple pregnancies.
Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)

This is a 2-phase retrospective database study, using both case-cohort and inception (intention-to-treat) cohort analyses to evaluate any association between oral treatments for osteoporosis and the risk of esophageal cancer in women.


Eligibility Criteria:
Inclusion Criteria:

* Cases:

  * Women in the database aged 55 or older between 1996 and 2008 with diagnosis of esophageal cancer
* Comparator Controls:

  * Each case was matched to all women in the random subcohort of 25,000 who had the same year of birth as the case and were in the database at the time of diagnosis.

Exclusion Criteria:

* Women with diagnosis of any other cancer or Paget's Disease or who have received oral or intravenous steroids before the index date
Effectiveness of Blood Clot Medication With Concomitant Blood Pressure Medication

Patients in intensive care units have higher risks for developing blood clots. Arixtra inhibits blood clot formation by binding with the blood clotting factor, Xa. Critical illnesses and, specifically, medications given in the ICU to increase arterial blood pressure (vasopressors) may impair the absorption of drugs like Arixtra that are given subcutaneously. The study will measure the levels of Arixtra in blood comparing those subjects who are and those subjects who are not on blood pressure medication.

In view of the high risk of venous thrombolism (VTE) in critically ill patients, it is essential for all ICUs to develop a standardized approach to thromboprophylaxis. Several studies in a critical setting have shown that both low dose unfractionated heparin and low molecular weight heparin (LMWH) reduce the incidence of VTE and either one of them is recommended as a valid agent by the newer ACCP consensus guidelines.

However, even with prophylaxis, critically ill patients still develop VTE. Common conditions amongst ICU patients such as generalized edema, poor peripheral perfusion during shock states, moderate renal dysfunction, etc., are possible explanations for this observation. Additionally, the use of vasoactive drugs may also impair peripheral circulation and reduce effective levels of agents used for the prevention of VTE.

This prospective clinical trial will be conducted to assess whether impaired peripheral circulation due to vasopressor (blood pressure) infusion decreases the bioavailability (i.e., plasma concentration) of subcutaneously administered fondaparinux (i.e., does vasopressor infusion lower blood plasma concentrations of fondaparinux), thereby reducing the prophylactic benefits of fondaparinux administration.

Fondaparinux (Arixtra®) was chosen as the anti-thrombotic agent to be used in this study because of its unique pharmacological properties and its safety and efficacy amongst different medical populations. Fondaparinux sodium administered by subcutaneous injection is rapidly and completely absorbed (absolute bioavailability is 100%). Following a single subcutaneous dose of fondaparinux sodium 2.5 mg in young male subjects, Cmax of 0.34 mg free acid/L is reached in approximately 2 hours. In patients undergoing treatment with fondaparinux sodium injection 2.5 mg, once daily, the peak steady-state plasma concentration is, on average, 0.39-0.50 mg free acid/L and is reached approximately 3 hours post-dose. Because fondaparinux does not react with platelet factor IV, thrombocytopenia is not an unwanted side effect.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients 18 or over, weight 50 kg or more in the ICU will be enrollment eligible. Pregnant women and those with neuraxial anesthesia, renal or liver problems, or BMI over 40 are not eligible.

Exclusion Criteria:

* Patients under 18, weight less than 50 kg, pregnant women and those with neuraxial anesthesia, renal or liver problems, or BMI over 40 are not eligible.
UTMB Research on Severe Asthma (UROSA) Study

To identify and understand biologic aspects of severe asthma compared to subjects with mild to moderate asthma and subjects without asthma (normal or healthy volunteers).

It has been shown that severe asthma differs from milder asthma in its pathophysiology; in particular we are interested in examining why patients with severe asthma have disease that is resistant to corticosteroids. While we will be studying patients with severe asthma, we also need to study subjects to act as controls. To this end we will recruit subjects into the following groups: Normal volunteers; Mild asthmatics not taking inhaled corticosteroids; Mild to moderate asthmatics requiring and using inhaled corticosteroids and Severe asthmatics.

Subjects between the ages of 18 and 65 will be enrolled in this study. We aim to recruit enough subjects such that 120 male and female participants (30 in each of the above groups) will complete the bronchoscopy.

Eligibility Criteria:
Inclusion Criteria:

* All participants must be in good general health (with exception to asthma). • Normal controls / healthy volunteers (NC) subjects with no past history of asthma or other lung disease. To determine this, subjects must have an FEV1 equal to or greater than 80% of predicted value and have a normal FEV1/FVC ratio.

Asthma subjects Eligible asthmatic participants must have a physician diagnosis of asthma for at least 1 year. Participants must either have historical evidence of reversibility of FEV1 of at least 12%, or demonstrate such a change during the study visits, or must have historical evidence of a PC20 for methacholine \< 8mg/ml.

* Mild Asthma with no Corticosteroids (MANC) will be defined as control of asthma with short acting β2-agonists or leukotrine antagonist or both, but not requiring inhaled corticosteroids.
* Mild to Moderate asthma (MMA) will be defined as control of asthma with an inhaled corticosteroid (less than or equal to 250 mcg daily inhaled fluticasone equivalent) in addition to the medications listed in the MANC group or long acting β2-agonists.
* Severe asthma (SA) will be defined according to the ATS criteria for Refractory Asthma (10)

Exclusion Criteria:

* Exclusion criteria apply for all subjects:

  * Current smoker, or former smoker with \>10 pack years history or having quit within the past year
  * Asthma exacerbation, requiring a new or increased dose of oral corticosteroids, within the past 30 days
  * Pregnant or lactating female
  * Significant/uncontrolled medical condition (uncontrolled diabetes, coronary artery disease, uncontrolled hypertension)
  * Diagnosis of emphysema or other significant pulmonary disease
  * If, in the opinion of the PI (WJC) the subject has co-morbid conditions that make them unsafe to undergo bronchoscopy, subjects will be given the choice to withdraw from the study or allowed to complete visits 1-3 only.