cyrilzakka/clinical-trials huggingface dataset:
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers Volunteers

The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
* Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* SBP \< 90 mmHG, SBP \> 140mmHG or DBP \< 60 mmHG, DBP \> 100mmHg
* AST or ALT \> X 2 UNL
* CK \> X 2 UNL
* History of drug abuse or positive drug screening.
* Participation in other drug studies within 3 months prior to the drug administration.
* Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
Refinement and Validation of an Awareness Training Program

The goal of the proposed project is to provide the Army with a brief, well-validated, internet-based training program for enhancing Awareness Training and resilience skills. This project will address the needs outlined for the Military Operational Medicine Research Program, particularly with regard to enhancing Psychological Health and Resilience. The fundamental approach of the project directly addresses the need to "develop psychological resilience among Service members and families to promote well-being and prevent behavioral health outcomes." Addressing this need is crucial, as military personnel are often required to serve under dangerous and emotionally stressful conditions. Prolonged stress or exposure to very intense life threatening experiences, such as those encountered in combat or other hazardous duty deployments can increase the risk of developing mental health problems including depression, anxiety, or post-traumatic stress disorder (PTSD). One possible way to minimize the effects of these stressful experiences on Service members is to strengthen their emotional flexibility, adaptability, and capacity to cope with adversity before they find themselves faced with such situations. To fill this need, the investigators propose to provide the military with a web-based program that focuses on enhancing Awareness Training, a core set of trainable awareness skills that collectively include the capacity to understand, perceive, control, and use emotions effectively.

While the previous pilot program was successful in some ways, it needs further research before it is ready for widespread use. The investigators therefore propose to build upon the existing strengths already in the program and redesign the weaker modules to be more effective. Over the course of a four-year study, the investigators propose to develop this program. The proposed Awareness Training program is brief, web-based, easily accessible, and sufficiently focused such that it could be completed by large numbers of military personnel with minimal time burden, leading to rapid enhancement of awareness skills. Such a program could have a significant effect in promoting resilience, interpersonal functioning, and brain health among Service members and their families, while reducing the likelihood of mental health problems among those returning from exposure to potentially traumatic experiences.

The central hypothesis is that a set of well designed and targeted training modules addressing core awareness ability domains will significantly enhance measured awareness skills, will translate into improved performance on militarily relevant metrics, and will lead to better mental and emotional health, as well as well being during stressful situations and subsequent cognitive processing.


Eligibility Criteria:
Inclusion Criteria:

* English as a primary language

Exclusion Criteria:

* History of neurological illness, current DSM-5 Axis I disorder
* Traumatic brain injury with loss of consciousness greater than 30 minutes
Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae

This trial is designed to gain insight into the mechanism of action of eflornithine hydrochloride in men and to aid in determining if this compound is deserving of further development for a pseudofolliculitis barbae indication. This study will also provide knowledge which will be useful in designing future PFB trials in this indication is pursued.

The proposed mechanism of action of eflornithine hydrochloride for treatment of hair growth is that it reduces the rate of cell growth within the hair follicle by inhibition of the enzyme ornithine decarboxylase (ODC). In preclinical studies eflornithine hydrochloride was shown to inhibit ODC and decrease hair mass. In sheep, systemic inhibition of ODC by eflornithine hydrochloride markedly altered not only the length and diameter of hair fibers, but also the portion of the hair fiber cross-section occupied by paracortical cells, which are primarily found in straight hairs. In a Phase II study evaluating the effect of the drug in the treatment of female hirsutism, it was anecdotally noted that those who also had PFB showed an improvement in this condition.

Eligibility Criteria:
Inclusion Criteria:

* Males age 18 or older of African American descent.
* History of PFB localized to the beard area of at least 2 years duration confirmed by a dermatologist.
* PFB grade 3 (ingrown hairs and 20 or more papules of 2mm or greater in diameter with inflammation with minimal pustules) or greater involving the beard area of the face.
* Customary frequency of removal of facial hair by wet shaving at least once per week.

Exclusion Criteria:

* Use of topical medications on the face within 2 weeks prior to treatment.
* Use of systemic steroids, antibiotics, lithium or isotretinoin within 2 months prior to pretreatment. Use of etretinate or acitretin within one year prior to pretreatment.
* Use of systemic antiandrogens, spironolactone, growth hormone, immunostimulants. immunosuppressants, 5-alpha reductase inhibitors. minoxidil dehydroepiandrosterone (DHEA) or other medications considered to have an effect on hair growth within 6 months prior to pretreatment.
* Use of physical hair removal techniques (laser, electrolysis, epilation) or chemical removal products (depilatories, waxing, sugaring) within 4 weeks prior to pretreatment.
* Presence of bacterial infections in the beard area including abscesses (3 or more) covering greater than 10% of the face and/or severe inflammatory acne.
Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients

The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II.
* Scheduled to undergo hip or proximal femur surgeries.

Exclusion Criteria:

* Refusal of participation by parents or caregivers
* Known local anesthetic (LA) drug sensitivity
* Bleeding disorders with INR \> 1.5 and/or platelets \< 100,000/mm3.
* Skin lesions or wounds at the site of proposed needle insertion.
Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome

The TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) study is a prospective, observational longitudinal study to evaluate the real world effectiveness and use of prasugrel and other ADP receptor inhibitor therapies among myocardial infarction (MI) participants treated with percutaneous coronary intervention (PCI) during the index hospitalization. Participant management and treatment decisions are at the discretion of the care team per routine clinical practice. Approximately 17,000 participants will be enrolled at approximately 350 sites in the United States. Follow-up will be conducted through 15 months in approximately 15,650 participants.

TRANSLATE-ACS will complement the results of both randomized controlled clinical trials and current registries in addressing the real world treatment patterns and clinical outcomes for MI participants managed with PCI and initiated on ADP receptor inhibitor therapy. In addition to determining the effectiveness of prasugrel in comparison to other ADP receptor inhibitors, the study will also determine factors associated with initial ADP receptor inhibitor selection and longitudinal patterns of use, evaluate the safety, and describe and compare resource use and medical costs associated with ADP receptor inhibitors. Additionally, this study will generate a continuum of information from the inpatient to outpatient settings to provide a comprehensive picture of participant treatment and outcomes not currently available for novel ADP receptor inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* greater than or equal to 18 years of age
* diagnosed with NSTEMI or STEMI treated with a PCI during the index hospitalization
* initiated (or continued) on ADP receptor inhibitor therapy before discharge
* fully informed and are able to provide written consent for longitudinal follow-up and data collection

Exclusion Criteria:

* simultaneously participating in a research study that directs choice of either an investigational or approved ADP receptor inhibitor within the first 12 months after MI
Percussion Palm Cup: Safety and Usability in Infants and Children With Cystic Fibrosis

Cystic Fibrosis is the most prevalent fatal genetic disease affecting Canadian children and it primarily characterized by a thickening of pulmonary secretions and impaired mucociliary clearance. Chest physiotherapy has been widely used as a standard treatment for sputum mobilization and clearance for individuals with CF. Percussion is one such technique of chest physiotherapy for loosening trapped music within the lungs and can be completed manually or facilitated with a percussion cup. Unfortunately, the exclusive Canadian supplier for the widely use percussor cup has stopped distributing the cups, leaving many hospitals and therapy clinics searching for alternatives to continue airway clearance treatment. The goal of this project is to compare alternative palm cup solutions to the standard, and recommend safe alternative(s) that caregivers can have easy access to.

An average adult hand may be too large and taxing for percussion on infants and children, therefore percussor palm cups facilitate caregivers and physiotherapists. The palm cup mimics the air compressed through cupped hands and can be used in conjunction with other physiotherapy techniques and has been shown to have a positive impact on symptoms. Engineers at McMaster University have developed 3D-printed prototypes to use with percussor cups that are made with material similar in consistency and flexibility to the no longer manufactured, standard cup. These cups will be tested in infants and children with cystic fibrosis recruited from the Cystic Fibrosis Clinic at McMaster Children's Hospital in Hamilton, Ontario.

Patients/guardians/caregivers will be given 3 percussor palm cups to use over the course of 6 days (one standard cup and two 3D-printed). Each cup will be trialed for 2 days, allowing for equal time dedicated to each. Demographic data and characteristics will be collected at baseline, and measures of safety and usability will be completed at the end of the week of use. Overall satisfaction will be recorded at the end of the questionnaire. Participants will be asked to rate percussion palm cups from least preferred to most preferred and an open-ended question to explain their reasoning on the experience.

Thus, the purpose of the study is to examine the safety, usability and user experience of newly designed percussion palm cups using 3-D printing. The results of this study will have important implication to the management of infants and children with CF given the percussion palm cup shortage.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children with CF under the age of 6 and their parent/guardian/caregiver to perform chest percussions using percussor palm cups.
* Participants must currently require regular chest physiotherapy.

Exclusion Criteria:

* A comorbid condition that is a contraindication for the use of percussor palm cups.
* Inability of parent/guardian/caregiver to complete written questionnaires due to visual or cognitive impairment.
PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

The goal of this randomized controlled trial is to examine the impact of programmed intermittent bolus epidural analgesia technique on the incidence of breakthrough pain during labor in nulliparous women compared to continuous epidural infusion.

Nulliparous women will randomly be divided during labor into two groups; study group will receive mix of Bupivacaine and fentanyl once (bolus) every 60 minutes; the control group will receive continuously the same dose during an hour, until delivery.

There are several pharmacological and non-pharmacological techniques for pain relief during labor. Epidural analgesia is considered the most effective modality for intrapartum pain relief.

Maintenance of epidural analgesia is achieved by different techniques; continuous epidural infusion (CEI), intermittent epidural analgesia (IEA), patient control epidural analgesia (PCEA) and combination between the techniques.

Another technique, the Programmed Intermittent Bolus Epidural Analgesia (PIBEA). The advantage of this technique is that boluses are given all the time at planned intervals, so laboring women do not depend on the medical staff to receive the bolus when there is a breakthrough pain.

This method has been reported to be associated with less motor block, lower incidence of instrumental vaginal deliveries, and less consumption of anesthetic agents when compared to CEI. There are no conclusive data regarding the use of PIBEA in combination with PCEA compared to CEI and PCEA on the effect of pain relief during labor and birth outcomes. The hypothesis of the current trial is that PIBEA and PCEA will decrease the incidence of breakthrough pain, and probably shorten the second stage of labor, lead to fewer instrumental deliveries and higher women's satisfaction compared to CEI and PCEA.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* Term pregnancy
* Singleton
* Vertex presentation
* Latent phase (cervical dilatation \<6 cm)
* Epidural analgesia request
* Visual Analogue Scale score \> 40

Exclusion Criteria:

* Estimated fetal weight \> 4 kg
* Intra uterine fetal death
* Drug sensitivity
* Anomalous fetus
* Contraindication for epidural analgesia
A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis

This is a hybrid, double-blind, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will be randomized into either the intervention product or control group and will consume the test product or control daily. Participants will complete study-specific and validated questionnaires at Baseline, Week 6, and Week 12, as well as blood biomarker testing for a lipid panel and high-sensitivity C-reactive protein (hs-CRP) at Baseline and Week 12.

Osteoarthritis-like symptoms, such as joint pain, inflammation, and reduced mobility will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores. Two validated questionnaires, Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Numeric Pain Rating Scale (NPRS) will also be completed at the questionnaire time points. A full lipid panel and hs-CRP measurement will be completed via in-person blood draws.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 50-75 years of age
* Self-reporting osteoarthritis-like symptoms, experiencing 3 or more of the following symptoms: joint pain, inflammation, reduced mobility, joint swelling, and stiffness.
* Non-acute osteoarthritis, must have experienced symptoms for longer than 1 year.
* Generally healthy and don't live with any uncontrolled chronic disease
* Able to eat eggs (haven't been medically advised to avoid)
* Willing to stop eating eggs for the 12 week study

Exclusion Criteria:

* Anyone allergic or intolerant of eggs
* Anyone who has been advised to avoid eggs
* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Anyone with known severe allergic reactions.
* Women who are pregnant, breastfeeding or attempting to become pregnant
* Unwilling to follow the study protocol.
* Subjects currently enrolled in another clinical study
* Subjects having finished another clinical study within the last 4 weeks before inclusion
* Hypersensitivity, allergy, or intolerance against any compound of the test products (e. g. eggs)
* Recent implantation of a cardiac pacemaker or other active implants
* History of or present liver deficiency as defined by Quick \< 70%
* History of hepatitis B, C, HIV
* Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
* Simultaneous study participation by members of the same household
* Any diet to lose body weight
* Eating disorders or vegan diet
* Present drug abuse or alcoholism
NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study

In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain. The purpose of our study is to determine the impact of this problem and to better understand its risk factors.

In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain.

The purpose of our study is to determine the impact of this problem and to better understand its risk factors.

This is a poorly studied issue and the study could better detect, evaluate and treat painful patients after knee replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective primary Total knee arthroplasty or unicompartmental knee arthroplasty due to knee joint osteoarthritis
* Older than 18 years
* Willing and able to complete pre and postoperative surveys

Exclusion Criteria:

* History of drug abuse
* Previous knee arthroplasty
* Mental disorders
* Rheumatoid arthritis
* Chronic renal disease
* Chronic hematological diseases (sickle cell disease, haemochromatosis...)
Changes in Hematological Parameters With Glycemia Control in Type 2 Diabetes

There is a systemic low-grade chronic inflammation in diabetes, and research suggests that this inflammation plays a vital role in the development of diabetic complications. Macrovascular complications, which are associated with atherosclerosis, are recognized as a chronic inflammatory disease. In this study, the aim was to evaluate the potential alteration in hematologic inflammatory markers among patients with poorly controlled type 2 diabetes subsequent to the enhancement of diabetes management.

Patients who were referred to the Diabetes Outpatient Clinics and had HbA1c levels equal to or greater than 10% were enrolled in this study. Detailed medical histories, comorbidities and medication usage (including both regular and new prescriptions), adherence to dietary recommendations, and occurence of recent infections were collected. Additionally, the patients' biochemical and hematological data were collected. After a three-month period, follow-up interviews with the same patients were conducted to inquire about any changes in medication usage, experienced illnesses, and hospital admissions. Based on the changes in HbA1c levels during this three-month period, the patients were divided into three equal groups. The baseline and third-month leukocyte counts, neutrophil counts, lymphocyte counts, and platelet counts for these groups were recorded. Furthermore, the neutrophil/lymphocyte ratio, lymphocyte/monocyte ratio, platelet/lymphocyte ratio, monocytes/HDL-cholesterol ratio, and platelets/HDL ratio for each group were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* having type 2 diabetes
* giving consent to the study
* HbA1c level \>=10 %

Exclusion Criteria:

* presence of acute infection
* presence of other diseases that can cause inflammation
* hematological diseases
* acute metabolic decompensation
* not being able to come to follow-ups
* presence of non-thyroid endocrine disease
* application of oncologic treatment
* leukocyte count \>12 000
Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis

The purpose of this study is to assess safety and tolerability of once daily (QD) and twice daily (BID) dosing of ANG-3070 in subjects with idiopathic pulmonary fibrosis (IPF) who are treatment-naïve, refused therapy, or discontinued for any reason current standard of care with nintedanib or pirfenidone.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be willing and of sufficient mental capacity to give written informed consent and comprehend the importance of adhering to study treatment and requirements.
2. Male or female subjects aged 40 years and older at the time of informed consent.
3. Substantiated diagnosis of IPF based on clinical, radiological, and/or pathologic data to the exclusion of alternate diagnoses that would contribute to extant interstitial lung disease (ILD) based on the opinion of the subject's physician using current diagnostic criteria.
4. Subject:

   * Is naïve to therapy with nintedanib or pirfenidone OR
   * Refuses therapy with nintedanib or pirfenidone OR
   * Had nintedanib or pirfenidone discontinued due to any reason, 4-week washout required

Exclusion Criteria:

1. Diagnosis of asthma or chronic obstructive pulmonary disease (COPD).
2. Current tobacco use (quit at least 1 month prior to study for inclusion).
3. Presence of active infection requiring ongoing therapy with systemic antibiotics and/or antivirals.
4. Diagnosis of connective tissue disease.
5. Known cause of ILD diagnosed.
6. Active malignancy aside from local carcinoma.
7. AST or ALT or total bilirubin \> 2x upper limit of normal (ULN).
8. Pregnancy and/or lactation; positive serum beta human chorionic gonadotropin (β-HCG) during screening.