cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers

The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of a single dose of glyburide.

This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), single-center, fixed-sequence study (all volunteers receive the same medication on the same days) to determine how canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics and pharmacodynamics of glyburide (a blood glucose-lowering agent used to treat patients with diabetes). The study will consist of 3 phases; a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. During the open-label treatment phase, each volunteer will receive a single 1.25 mg dose of glyburide on Day 1, followed by 200 mg canagliflozin once daily on Days 4 through 8. On Day 9 volunteers will receive both glyburide 1.25 mg and canagliflozin 200 mg. Each volunteer will participate in the study for approximately 40 days.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer must have a body mass index (BMI = weight in kg/height in m2) between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg Exclusion Criteria:
* Volunteer has a history of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
* Volunteer has a fasting plasma glucose \< 100 mg/dL (as measured by oral glucose tolerance test) and a 2-hour plasma glucose \<= 140 mg/dL
* History of smoking or use of nicotine-containing substances within the previous 6 months
Prosthetic Performance Enhancement Trial

The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.

Despite advances in the technology for artificial limbs (prostheses), falling and the fear of falling continue to be barriers to mobility for many lower limb prosthesis users after their initial rehabilitation. The loss of ability and confidence in pursuing everyday tasks negatively impacts quality of life, and ongoing physical and mental health. This study will test and improve a rehabilitation training intervention involving walking on uneven ground to improve walking skill and confidence in lower limb prosthesis users.

Lower limb prosthesis users will be recruited. Participants will be allocated randomly to receive either intervention A: training on a flat surface, or intervention B: training on an uneven surface. Depending on their ability and confidence, participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern. The walking practice will take place three times per week for four weeks. As each participant improves their ability, training tasks will be made more difficult by limiting handrail use, by increasing walking speed, and, for intervention B, also by making the walking surface more uneven.

The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices.

Eligibility Criteria:
Inclusion Criteria:

* lower limb amputation at ankle (Symes) level and above
* age 18+ years
* fitted with a walking prosthesis and use it regularly for home and/or community ambulation
* good socket fit, assessed by a score of 8-10 on the socket fit comfort scale
* able to walk for three minutes at a time with or without an assistive device
* willing to travel to the University of Nevada Las Vegas, Maryland Campus, for all training and assessment sessions

Exclusion Criteria:

* leg/foot ulcer or other conditions that cause pain during weight-bearing
* poor skin integrity that could cause tissue breakdown by walking
* cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity
* unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use.
* pregnancy
Identifying Barriers to Implementing Sensory Strategies in the Classroom Setting

The goal of this clinical trial is to determine barriers to implementing sensory strategies in the classroom setting as well as potential supports needed in teachers and paraprofessionals 18 years and older who are actively working in the classroom setting. The main questions it aims to answer are:

1. What are common themes that limit classroom staff from implementing sensory strategies within the classroom setting?
2. What support do classroom staff need from an occupational therapist to feel confident in implementing sensory strategies within their classroom?

Participants will be asked to participate in a 17-item electronic survey via Google Forms. They will be asked to provide informed consent prior to participating.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Active teacher or paraprofessional working in the classroom

Exclusion Criteria:

* Younger than 18 years old
* Teachers or paraprofessionals no longer actively working in the classroom setting
Cortisol Augmentation of Prolonged Exposure Therapy

This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.


Eligibility Criteria:
Inclusion Criteria:

* Veterans who experienced a criterion A trauma while deployed, and a current diagnosis of PTSD with a minimum of 6 months
* Capable of understanding, reading and writing English

Exclusion Criteria:

* Incapable and/or unwilling to provide written informed consent prior to participation
* Unwilling and/or unable to discontinue current psychotherapy
* Regular use of psychotropic medication including antidepressants, benzodiazepines, lithium, mood stabilizers, over-the-counter supplements (melatonin, kava-kava, ephedra)
* Regular use of oral or inhaled steroids
* Significant illness (e.g., type I or II diabetes requiring the use of insulin, HIV, AIDS, seizure disorder, anemia, Lyme disease, etc.)
* The veteran, the veteran's physician, or the study physician think that the veteran's clinical state necessitates the prompt initiation of pharmacotherapy or other treatment that would preclude involvement in the study
* Morbid obesity (VMI \> 40)
* Clinically significant laboratory abnormalities as determine during medical clearance procedures
* For women, a positive pregnancy test
* Heavy smoking (more than 2 packs a day)
* Substance and/or alcohol abuse and/or dependence within the previous 6 months
* Response of 3 or 4 on the suicidality items of the HDRS or an assessed serious suicide risk
* Current psychosocial problems that might interfere with treatment compliance
* A lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, obsessive compulsive disorder or PTSD due to a trauma not sustained in the combat theater
Assessment of AI Prediction Models in Prediction of Acute Kidney Injury in Critical Patients

The assessment of AI -based prediction models in detecting AKI early in critically ill patients. Specifically, the aim is to evaluate the model's ability to predict the onset of AKI before it clinically manifests allowing for early interventions

Acute kidney injury (AKI) is the most severe, common, and life-threatening complication in hospitalized patients and is associated with high morbidity and mortality rates . It has been demonstrated that AKI affects approximately 30-60% of critically ill patients, especially those in the intensive care unit (ICU) . Despite the recent advances in clinical care and dialysis technology, the occurrence of AKI in ICU patients has a mortality rate of up to 50%, which is 1.5 to 2-fold to that of ICU patients without AKI . However, if detected and managed promptly, interventions guided by established recommendations, such as those provided by KDIGO, may mitigate the risk of further deterioration in AKI patients . Therefore, identifying individuals at high risk of AKI is vital for managing critically ill patients.

Artificial intelligence (AI) and machine learning (ML) represent emerging technologies that could use large amounts of health-related data to help physicians make better clinical decisions and improve individual health outcomes. While serum creatinine (Scr) and urine output serve as diagnostic criteria for AKI, delays in their detection may occur. Therefore, early identification of patients at risk of developing AKI is crucial to create a window for preventive interventions and mitigate the risk of further deterioration. Several previous studies have developed various ML-based models to predict AKI in critically ill patients due to the potential benefits of early detection of AKI . It is critical to remove the mystery surrounding ML since doing so makes it simpler for doctors to comprehend the reasoning behind ML . In order to explain why ML makes the choices it does, a new field called Explainable AI (XAI) has emerged. Two of the most popular methods for explaining are Local Interpretable Model-Agnostic Explanation (LIME) and Shapley Additive Explanation (SHAP) . Novel interpretable approaches have been effectively utilized to explain ML models for preventing hypoxemia during surgery \[10\], predicting mortality in sepsis and AKI , predicting the occurrence of AKI following cardiac surgery , and predicting antibiotic resistance .

To the best of our knowledge, the reliability and robustness of explanatory techniques for detecting AKI in critically sick patients have rarely been studied. Therefore, the present study was conducted to construct an ML approach for the early prediction of AKI in ICU patients and to apply XAIs to make ML more transparent and interpretable.

Eligibility Criteria:
Inclusion Criteria:

* All adult (aged 18 years old and older) patients who were admitted to the ICU were included in this study.

Exclusion Criteria:

* • patients under 18 years old

  * End-stage renal disease
  * Acute Kidney Injury at ICU admission
  * Inability to obtain sufficient clinical data
Intra-articular Injection Versus Normal Rehabilitation Therapy on Temporomandibular Joint Dysfunction

The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction

The main question it aims to answer is:

• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction

The background of Temporomandibular Joint Dysfunction is that it is one of the common diseases in the oral and maxillofacial region, and it is the most common among temporomandibular joint diseases. It is more prevalent in young adults, with the highest prevalence rate at 20-30 years old.

The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction

The main question it aims to answer is:

• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction

Eligibility Criteria:
Inclusion Criteria:

* Presence of significant temporomandibular disorder clinical symptoms.
* Meeting the diagnostic criteria for Temporomandibular Joint Dysfunction and confirmed by X-ray examination.
* Patients voluntarily participate in this study and provide signed informed consent.
* Normal cognitive function

Exclusion Criteria:

* Rheumatic, rheumatoid, or other severe systemic diseases.
* Infectious temporomandibular joint arthritis or joint tumors.
* Individuals who have recently received joint injection treatment or photodynamic therapy.
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants

The primary objective of the study is to investigate the short-term antiviral potency of bictegravir at multiple doses in antiretroviral (ART) treatment-naive adult participants and participants who are ART-experienced but integrase strand transfer inhibitor (INSTI) naive.


Eligibility Criteria:
Key Inclusion Criteria:

* No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis \[PrEP\]), or postexposure prophylaxis (PEP) within 12 weeks of screening
* Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
* Cluster of differentiation 4+ (CD4+) cell count \> 200 cells/mm\^3

Key Exclusion Criteria:

* Anticipated to start HIV-1 therapy during the study period
* Active participation in another study of investigational or approved ART agents
* A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
* Participants with positive hepatitis C antibody at screening
* Chronic hepatitis B virus (HBV) infection
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Military Health and Nutrition Examination Study

The Military Health and Nutrition Examination Study (MHANES) is a Department of Defense funded study conducted by Pennington Biomedical Research Center and the US Army Research Institute of Environmental Medicine. This cross-sectional study will assess, in a large, diverse sample of Army Service Members (n=600), food and supplement intake, cardiovascular health, body composition, biomarkers of nutritional status, measures of health status, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance outcomes. The proposed study is modeled after the National Health and Nutrition Examination Survey (NHANES) and customized for the Army population.

Background: Comprehensive scientific data on dietary intake, nutritional status, cardiometabolic health, and performance of a representative sample of active-duty Soldiers are not available. Collecting such data will allow for assessment of disease prevalence and health status, provide novel descriptive information, and examine relationships between health and nutrition variables that are currently unavailable on the Army active-duty population.

Study Aim: To assess, in a large, diverse sample of Army Service Members, dietary intake, nutritional status, cardiovascular health, body composition, metabolic biomarkers of nutritional state, and other measures of health status.

Eligibility Criteria:
Inclusion Criteria:

* U.S. Army Soldiers ≥ 18 years old
* Willing to have biological samples stored for future use
* Willing to have data linked to the Soldier Performance, Health, and Readiness (SPHERE) database

Exclusion Criteria:

* Soldiers under the age of 18 years
* Soldiers with an inability to understand verbal or written instructions or testing materials in English
* Soldiers relocating or getting out of the Army in the next 30 days
* Pregnant females
* Soldiers currently in Basic Training (BCT) and/or One-Station Unit Training (OSUT)
The Effects of Hypobaria vs Hypoxia on Cerebral Functions.

The investigators will investigate the effect of hypobaria and hypoxia on physiological responses such as: oxygen saturation, heart rate, cerebral blood flow, cerebral oxygenation, brain's activity and concentration performance.

The main goal of this project is to investigate how hypoxia affects cognitive functions. The KLT-R test asses the concentration level of a person. Subjects will do this test at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Investigators' first hypothesis is that concentration level will be altered by hypoxia. The higher altitude the subjects are, the more the concentration would be altered. KLT-R performance would be impaired by hypoxia compare to sea level performance.

The primary endpoint of this project is to investigate how KLT-R performance is affected by the different hypoxic conditions. KLT-R test will be passed nine times in total during the test visit. There will be a pre-test; a test at each of the conditions (3000m HH, 5500m HH, 5500m NH and 5500m HN); between each condition at sea level (to have a new baseline before each condition) and a post-test at the end of the protocol. To avoid influence of fatigue, all conditions will be randomized.

The second endpoint of this study is how the brain electrical activity is modulated by hypoxia. Micro-states also will be measure during hypobaric hypoxia conditions (3000m HH and 5500m HH).

Eligibility Criteria:
Inclusion Criteria:

* No history of flight sickness
* No relevant medical diseases
* Age 18 - 40 years
* Written consent acceptance

Exclusion Criteria:

* Known pathologies
* Relevant medical disorders
* Drug addiction
* Anemia or poor health
* People who have already had problems with elevation
Modulation of Genes Responsible for Cilia Length by Exposure to Cigarette Smoke

Cigarette smoking is the major risk factor for developing chronic obstructive pulmonary disease (COPD). Patients with COPD have difficulty clearing mucus and debris from their airways. Even smokers who have not developed COPD may have difficulty clearing the airways. This is partly because smoking impairs the function of cilia, tiny hairs lining the airways that sweep out mucus to keep the airways clean. The investigators have found that smoking reduces the length of cilia, which may contribute to the worsened cilia function in smoking and COPD. This is true even in smokers who show no signs of lung disease. The investigators believe that smoking affects levels of genes in lung cells, resulting in shorter cilia.

In this study, we will use bronchoscopy (inserting a scope into the lungs) to obtain lung cells by brushing cells from the airways and we will study genes that may be related to cilia length. Our goals are (1) to prove that exposure to cigarette smoke results in shorter cilia, (2) to learn which specific genes control cilia length, and (3) to learn how smoking affects the gene ODF2 and what effect this has on cilia. Understanding how smoking affects cilia may help us identify new ways to treat patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

* Must be capable of providing informed consent
* Males and females, age 18 or older
* Nonsmoking, validated by venous carboxyhemoglobin and urine nicotine and cotinine within range for nonsmoker without smoke exposure, matched with smoker group by age, sex, ethnic/racial group
* Good overall health without history of chronic lung disease, including asthma, and without recurrent or recent (within 3 months) acute pulmonary disease
* Normal physical examination
* Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
* Negative HIV, hepatitis B and C serology
* Normal chest X-ray (PA and lateral)
* Normal electrocardiogram
* Females - not pregnant
* No history of allergies to medications to be used in the bronchoscopy procedure
* Not taking any medications relevant to lung disease or having an effect on the airway epithelium
* Willingness to participate in the study

Exclusion Criteria:

* Unable to meet the inclusion criteria
* Pregnancy
* Current active infection or acute illness of any kind
* Habitual use of drugs and/or alcohol within the past six months (Acceptable: -Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria)
* Evidence of malignancy within the past 5 years
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection

The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.

This is a Phase 2b multicenter study. The study will include a screening period of maximum 6 weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. The total study duration for each subject will be 36 to 38 weeks. This study investigates a 3 direct-acting antiviral agent (DAA) combination of AL-335 (HCV NS5B inhibitor), odalasvir (ODV) (a second generation HCV NS5A inhibitor) and simeprevir (SMV) (HCV NS3A4 protease inhibitor). The results of this study will enable the selection of treatment and duration to be further developed.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection
* Documented as treatment naive or experienced with a prior regimen consisting of Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response
* Absence of cirrhosis
* Screening laboratory values within defined thresholds
* Must use specific contraceptive methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
* Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination with pegylated interferon (PegIFN) or IFN-free
* Current or prior history of clinical hepatic decompensation
* History of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol
* Pregnant or a nursing female