cyrilzakka/clinical-trials huggingface dataset:
First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes

GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as compared to an inactive placebo medication. The second part of the study will assess the safety of repeated doses of GFB-024 in participants with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo medication.

This is a first-in-human study. It is intended to provide the initial safety, pharmacokinetics (PK), and pharmacology data for GFB-024 in humans. This study will comprise a single ascending dose (SAD) escalation component in healthy overweight and obese volunteer participants and a repeat-dose component to confirm repeat-dose safety, tolerability, PK, and immunogenicity in participants with Type 2 diabetes mellitus. It will also explore potential cannabinoid-1 receptor (CB1) activity, participant selection, pharmacodynamics, and differential response biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age at the time of signing informed consent.
* Body mass index (BMI) between 25.0 and 40.0 kg/m2, inclusive, at Screening.
* Female participants will be of non-childbearing potential.
* Male participants will agree to use contraception while on study intervention and for at least 6 months after the last dose of study intervention.
* SAD cohorts only: Participants must be in good health.
* Repeat-dose cohort only: Type 2 diabetes mellitus (T2DM) treated with lifestyle modification or metformin, and in otherwise good health except for well-controlled common conditions associated with T2DM, such as hypertension and dyslipidemia.

Exclusion Criteria:

* History of, or treatment for, psychiatric illness, including anxiety or depression within 5 years of the Screening visit.
* Participants with a history of attempted suicide or clinically significant suicidal ideation.
* History of cardiovascular disease.
* Blood pressure \>155 mmHg systolic or \>95 mmHg diastolic.
* History of alcoholism or drug/chemical abuse within 2 years prior to Screening.
* Alcohol consumption of \>21 units per week for males and \>14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1.5 oz (45 mL) liquor, or 5 oz (150 mL) wine.
* History of significant hypersensitivity, intolerance, or allergy to more than one class of drugs.
* Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
* SAD cohorts only: Fasting glucose \>126 mg/dL.
Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot

This is a pilot feasibility study of a virtual reality device for patients with co-morbid chronic pain and opioid use disorder.

The investigators will conduct a study of patients with co-morbid chronic pain and opioid use disorder enrolled in a methadone maintenance treatment program (MMTP) to pilot device feasibility and measure changes in pain intensity and opioid craving. All patients will be randomized to one of each of the following arms: 1) RelieVRx (intervention group) or 2) Non-immersive sham VR (control group).

The intervention being piloted is the RelieVRx - AppliedVR, Los Angeles, California - VR hardware and software. RelieVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.

RelieVRx is typically delivered in a 56-day program through daily virtual experiences, with each experience lasting between 2 and 16 minutes. In this pilot study, the investigators will conduct virtual experiences twice weekly at the MMTP. Over 6 weeks, participants in both groups will participate in 20-30 minute VR sessions twice per week. Each session will last about 20-30 minutes and go through 1-5 virtual experiences. The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx. Control participants will similarly experience 1-5 virtual experiences in each 20-30 session.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old
2. English proficiency
3. receiving methadone treatment for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) confirmed Opioid Use Disorder (OUD) in the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability
4. chronic pain of at least moderate pain severity (score ≥4 on the Pain, Enjoyment of Life, and General Activity (PEG) scale)
5. willingness to participate in all study components
6. ability to provide informed consent, assessed using consent teach-back

Exclusion Criteria:

1. conditions that could make participation in VR hazardous or cause adverse effects (current or prior diagnosis of epilepsy, seizure disorder, dementia, or migraines, any medical condition predisposing to nausea or dizziness, hypersensitivity to flashing light or motion)
2. conditions that could prevent proper use of the VR headset (stereoscopic vision or severe hearing impairment, or injury to eyes, face, or neck that prevents use of the VR headset)
3. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study
Effect of Posture and Passive Cycling on Cardiac Autonomic Control System in Children With Severe Cerebral Palsy

The investigators will examine the immediate contribution of position and movement on the functioning of the autonomic cardiac control system.

Standing position is a routine therapeutic tool for improving bone density in children with cerebral palsy. The autonomous immediate response for these children is defective. In recent years it has been shown that there is an association between bone density and autonomic function .

In this paper the investigators will examine how the addition of movement to standing subjects contribute to changes in heart rate and blood pressure.

The hypothesis is that the integration of movement while standing presents a change in the autonomic response and thus may improve bone density.

Eligibility Criteria:
Inclusion Criteria:

* Motor ability of GMFCS IV-V

Exclusion Criteria:

* Children with hip subluxation
* On Baclofen inhaler treatment
* Heart disease
* surgical procedures
Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer

This study, we will build upon our prior work and test the feasibility of a Mediterranean diet intervention for medically underserved men with prostate cancer seen at LBJ Hospital, a large safety net facility in Harris County, TX.

Primary Objectives:

To determine the feasibility of a Mediterranean diet-based intervention adapted for underrepresented minority men with prostate cancer, defined based on the following process measures68:

* Enrollment (completion of 25 patient accrual within 2 years)
* Retention (completion of the study through the 6-month time point, with ≥80% defined as successful)
* Adherence (the percentage of completed study sessions and clinic visits, with ≥70% considered successful).

Secondary Objectives:

To determine changes due to the Mediterranean diet intervention in the following measures:

* Mediterranean diet score (define using MEPA I calculated using FFQ data)
* Weight/BMI
* QoL (EQ-5D-5L)
* Physical activity (IPAS)
* Non-invasive biomarkers
* Gut microbiome
* Metabolomics

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate that is localized based on metastatic workup ordered by the treating physician (which may include CT scan, bone scan, MRI and/or other imaging). Note that metastatic workup is not required for enrollment.
* Diagnosis within 12 months prior to enrollment OR
* Currently managed on active surveillance, with initial biopsy being \<5 years from date of enrollment
* Self-identified Hispanic and/or Black/African American
* Patient at LBJ Hospital

Exclusion Criteria:

* Special dietary requirements such that patient is unwilling to attempt dietary change
* Inability to complete a food record
* Unwillingness to participate in study activities
* Inability to keep appointments
* Food allergy prohibitive of a Mediterranean diet, i.e. nuts allergy
Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients

STEMI is a serious type of coronary heart disease, which is a major cause of disability and death. Morphologically the key feature of remodeling is myocyte hypertrophy, myocyte loss from necrosis or apoptosis, as well as interstitial cell growth especially fibroblast proliferation leading to myocardial fibrosis .

Elevated serum LDL-cholesterol concentrations play a proatherogenic role by stimulating inflammation and oxidative processes.

Statins have been documented to retard fibrosis and ventricular hypertrophy by the cessation of myofibroblast activity. Clinical studies have proven that statins not only regulate lipids but also improve myocardial fibrosis, regulate cell proliferation and apoptosis, regulate ventricular remodeling, and protect the myocardium

1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. (80) patients diagnosed with STEMI will be enrolled from Alexandria university hospital.
4. Serum samples will be collected from patients at the time of admission for measuring the biomarkers.
5. Echocardiogram also will be obtained at the time of admission.
6. All enrolled patients will be divided into two group to receive either Atorvastatin (40 mg) or Rosuvastatin (20mg).
7. All patients will be followed up during 3 months' period. At the end of 3 months, Serum samples will be collected from patients for measuring the biomarkers and Echocardiogram will be repeated.
8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
9. Results, conclusion, discussion, and recommendations will be given.

Eligibility Criteria:
Inclusion Criteria:

1. Electrocardiogram showed abnormal elevation of the ST segment.
2. First myocardial infarction occurred.
3. The patients received one-stage percutaneous coronary intervention (PCI) therapy within 12 h.

Exclusion Criteria:

1. Severe cardiac insufficiency.
2. Hepatic insufficiency (continuous increase of serum transaminase more than 3 times of the upper limit of normal level).
3. Renal insufficiency (creatinine clearance rate \<30 mL/min).
4. Addition of others blood lipid lowering and antioxidant drugs during follow up period.
5. Familial hypercholesterolemia.
6. Malignant tumor.
7. Immune system disease.
8. Acute infectious disease.
9. Hypersensitivity to rosuvastatin and Atorvastatin.
Transient Infrared Imaging for Early Detection of Skin Cancer

The hypothesis or study goal is to determine whether functional dynamic infrared imaging can be used for melanoma and other skin cancer screening and/or diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* All lesion in easily accessible places
* Lesion less than 3.5 cm

Exclusion Criteria:

* Any minors
* Lesion close to vital organs
Eosinophil Markers and Development of Disease in Allergic Rhinitis

Inflammatory proteins from eosinophil granulocytes in blood from patients with seasonal allergic hayfever have been shown to predict development of asthma at a six-year follow-up. This study is a 15-year follow-up of the same patients to verify earlier results and study disease development.

The study consists of a single visit at which patients fill in a questionnaire on actual hayfever and asthma symptoms as well as current treatment. Blood samples and nasal lavages are drawn and analysed for eosinophils as well as eosinophil cationic protein and tryptase. Spirometry is performed.

If patients use drugs which can interfere with results, ie. corticosteroids or beta-agonists, biochemistry and/or spirometry are omitted.

Eligibility Criteria:
Inclusion Criteria:

* Participant in earlier study (1995)

Exclusion Criteria:

* Treatment with any kind of corticosteroid within two months will exclude from study of inflammatory parameters
Diagnosis and Comprehensive Treatment of Mediastinal Interventional Technique

The goal of this observational study is to learn abou Whether patients undergoing mediastinal disease diagnosis and combined treatment with intrapacial ultrasound-guided mediastinal opening techniques have greater clinical benefit.

The participants were physically ill. The main questions it aims to answer are:

* Whether the mediastinal ultrasound-guided mediastinal opening technique is more beneficial for the diagnosis of benign or malignant mediastinal diseases.
* Does the mediastinal ultrasound-guided mediastinal opening technique benefit the patient by ablating mediastinal masses using freezing, laser, or other means.

Mediastinal diseases were diagnosed by lymph node biopsy combined with NGS, ROSE and other techniques using transairway ultrasound-guided mediastinal opening technique. Ablation of mediastinal malignancies is performed using techniques such as freezing or laser.

Researchers will compare the experimental group with mediastinal opening and the control group without mediastinal opening to see if Mediastinal open technique benefits patients.


Eligibility Criteria:
Inclusion Criteria:

* Radiographic abnormalities of mediastinum
* Can tolerate general anesthesia
* Can tolerate bronchoscopy and has the condition to have mediastinal biopsy and treatment

Exclusion Criteria:

* Imaging or other tests can make a definitive diagnosis
* Cannot tolerate general anesthesia or tracheoscopic surgery
* Patients cannot sign informed consent forms
Evaluation of Stenfilcon A Versus Etafilcon A

Evaluation of two contact lenses

One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
* Has astigmatism less than or equal to -1.00D;
* Is an adapted soft contact lens wearer;
* Demonstrates an acceptable fit with the study lenses;
* Has no active anterior segment disease or known ocular disease.

Exclusion Criteria:

* A person will be excluded from the study if he/she:
* Has never worn contact lenses before;
* Has any systemic disease affecting ocular health;
* Is using any systemic or topical medications that will affect ocular health;
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses;
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye;
* Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
* Is aphakic;
* Has undergone corneal refractive surgery;
* Is participating in any other type of clinical or research study;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH

Since the reasons for differential immune reconstitution in HIV-infected patients are still not fully understood, we considered it reasonable to investigate whether the presence of primary HIV drug resistance mutations could be one of the factors of inadequate immune reconstitution.

Evaluation of unfavorable factors of immune reconstitution can help identify patients at risk of persistently low CD4 cell counts and CD4:CD8 ratios and requiring careful monitoring for progression to AIDS.

Untreated HIV infection leads to progressive and permanent impairment of the immune system, and the successive loss of peripheral blood CD4+ T lymphocytes results in progression to AIDS. Effective antiretroviral therapy (ART) can prevent the decline and even cause the restore of the normal level of CD4+ cells.

CD4+ count ≥ 500 cells/µl and CD4:CD8 ratio ≥ 1 are considered normal, while patients with persistently lower CD4+ and CD4:CD8 ratios despite ART treatment are defined as having an inadequate immune response, which may result in an increased risk progression to AIDS, and thus higher mortality rates. Clinical risk factors for impaired CD4+ regeneration have not been fully established, however, older age, male gender, low CD4+ cell count and low CD4:CD8 ratio at diagnosis are associated with a poorer immune response to ART.

As well, HIV drug resistance also plays an important role in the process of immune reconstruction. Despite the very good results of ART, the emergence of drug-resistant mutations in the HIV virus, which may lead to treatment failure, is a cause for concern. The prevalence of HIV-1 drug resistance mutations reported worldwide ranges from 5% to 25%. Primary drug resistance of HIV occurs in people who have not previously been treated with ART. These people start ART treatment with a lower genetic barrier, a higher risk of virological failure and a higher risk of developing resistance to other drugs, which may lead to insufficient immune reconstruction and progression to AIDS.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 confirmed infection
* ART naive patients \> 18 years
* virological suppression after 6 months of ART
* available results of HIV genotyping before the start of ART

Exclusion Criteria:

* hematologic neoplasms
* use of chemotherapy, immunosuppressive drugs and other myelotoxic agents
* lack of patient's consent to participate in the study
The Effect of Transition to Adulthood Education Program on Family Quality of Life and Perceived Stress Level

Negative emotions experienced during life processes and the burden of caregiving affect the quality of life of parents. It has been found that parents who care for their children with intellectual disability (ID) for a long time have difficulties in coping with stress and their quality of life is adversely affected. However, families play a key role in maintaining the care of their children with ID, so it is very important that parents are supported in the matters they need.

Mothers are generally the people who take on a large part of the burden of care for their children with intellectual disability (ID) in the family and are most affected by the negativities brought by the conditions. Providing support to mothers for the care and future planning of their children who have just passed into adult life and for their future planning is important both in terms of maintaining family well-being and creating positive effects in the lives of individuals with mental disabilities.

With this study, it is aimed to increase the quality of life of mothers and to reduce perceived stress levels with the training (YEGEP) modules to be given for the changing care needs of individuals with ID who have reached adulthood or are in transition. In addition, it is expected that the health risks of young adults with ID will be determined at an early stage, and their health will be improved and protected.

Eligibility Criteria:
Inclusion Criteria:

* Whose child is registered with the disability center,
* Have a young adult child between the ages of 20 and 35 with moderate and severe mental disabilities,
* Speaking Turkish and literate Turkish,
* Not visually and speech impaired,
* Mothers who volunteered to participate in the study will be included.

Exclusion Criteria:

• Mothers who did not volunteer to participate in the study and were illiterate in Turkish were not included in the study.
A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption

The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee.
* Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for \<10 years.
* BMI of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2.

Exclusion Criteria:

* Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal.
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome.
* History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee.
* Any significant acute or chronic medical illness.
* History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent
* Participants who have received a SARS-CoV-2 vaccine approved for Emergency Use Authorization by the US FDA that is not live attenuated may be considered for enrollment

Other protocol-defined inclusion/exclusion criteria apply