cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Bioavailability of GLPG1690 Given as Oral Capsule or Tablet

This study is a Phase I, randomized, open-label, cross-over study with three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet.


Eligibility Criteria:
Inclusion Criteria:

1. Male between 18-50 years of age, inclusive
2. Body mass index (BMI) between 18-30 kg/m2, inclusive, with a weight of at least 50 kg.
3. Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory findings.
4. Discontinuation of all medications except occasional paracetamol at least 2 weeks or 5 half-lives prior to the first study drug administration
5. Non-smokers and not using any nicotine-containing products.
6. Negative urine drug screen and alcohol breath test.
7. Current sexually active male agrees to use adequate contraception/preventive exposure measures from the time of first dose of study drug, during the study and until 12 weeks after the last study drug dose.
8. Subjects should be willing to consume the non-vegetarian high-fat and high-calorie breakfast.
9. Able and willing to sign the ICF

Exclusion Criteria:

1. Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
2. Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
3. History of or a current immunosuppressive condition.
4. Presence of abnormal liver function. Diagnosis of disease of Gilbert is accepted. Retesting is allowed.
5. Renal function with an estimated creatinine clearance \<80 ml/min based on the Cockcroft-Gault formula. Retesting is allowed.
6. Presence of any condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
7. History of malignancy within the past 5 years
8. Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QTcF \>450 ms, or a known long QT syndrome).
9. Clinically relevant abnormalities detected on vital signs.
10. Dietary requirements precluding participation in the study
11. Significant blood loss (including blood donation \[≥450 mL\]), or transfusion of any blood product within 8 weeks prior to the signing of ICF.
12. Active drug or alcohol abuse within 2 years prior to the initial study drug administration.
13. Consumption of large quantities of caffeinated coffee or tea (\>6 cups/day), or equivalent.
14. Concurrent participation or participation in a drug or drug/device investigational research study.
15. Subjects who participated in a previous study with the same compound (GLPG1690).
16. Investigator or any sub-investigator, or other staff or relative.
17. Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
A Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Administered to Patients With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to evaluate the efficacy and safety BIND-014 in patients with metastatic castration-resistant prostate cancer (mCRPC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Metastatic disease progressing despite castrate levels of testosterone
* Prostate cancer progression documented by PSA
* Surgically or medically castrated, with testosterone levels of \< 50 ng/dL
* Previous anti-androgen therapy and progression after withdrawal
* ECOG performance status of 0 to 1
* Adequate organ function
* Prior radiation therapy allowed to \< 25% of the bone marrow
* Prior hormonal therapy is allowed
* Patient compliance and geographic proximity that allow adequate follow-up.
* Patients with reproductive potential must use contraceptive methods
* Signed informed consent from patient

Exclusion Criteria:

* Active infection
* Any chronic medical condition requiring a high doses of corticosteroid
* Pathological finding consistent with small cell carcinoma of the prostate
* Brain metastasis
* Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
* Radiation therapy for treatment of the primary tumor within 6 weeks
* Radionuclide therapy for treatment of metastatic CRPC
* Prior systemic treatment with an azole drug
* Prior flutamide treatment within 4 weeks
* Prior bicalutamide or nilutamide within 6 weeks
* Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
* Administration of an investigational therapeutic within 2 weeks
* Second primary malignancy
* Presence of clinically detectable third-space fluid collections
* History of severe hypersensitivity reaction to polysorbate 80
* Peripheral neuropathy at study entry
Respiratory Monitoring During Right Heart

Respiratory monitoring during right heart catheterization to differentiate between various types of pulmonary hypertension; The effects of the cardiovascular system on the lung mechanical properties.

Differentiation between different kinds of pulmonary hypertension (PHTN) requires right heart catheterization. Monitoring heart failure patients is challenging in many. The study will enroll patients undergoing right heart catheterization (RHC) for the evaluation of heart failure and PHTN, based on the regular clinical practice. The regular indices as the right ventricle pressure (RVP), pulmonary artery pressure (PAP), pulmonary artery wedge pressure (PAWP), and cardiac output will be measured with the Swan Ganz Catheter and recorded.

Noninvasive measurement of the respiratory flow will be acquired by a medical approved flow-meter that is mounted on a simple plastic breathing mask.

Non-invasive system that includes three accelerometers that are attached to the chest and epigastrium of the patient will be used to measure respiratory chest wall dynamics.

Through evaluating the correlation between the invasive and non-invasive measurements the study intends to prove the ability of the non-invasive system to provide the required information.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing right heart catheterization

Exclusion Criteria:

* Inability or unwillingness to follow or to sign the study protocol.
Core Exercises and Their Effects on Sprint, Jump, Agility, and Balance in Amateur Soccer Players

This study aimed to investigate the effects of a 4-week core exercise program on sprint, vertical jump, agility, and postural sway performance in amateur male soccer players aged 18-23. Participants were randomly assigned to an intervention group (core training) or a control group (regular training). Physical performance tests were conducted before and after the training program. The results are expected to help coaches and sports scientists better understand the performance benefits of core training.

This randomized controlled study investigated the effects of a 4-week core exercise program on sprint, vertical jump, agility, and postural sway performance in amateur male soccer players aged 18 to 23. Thirty participants were randomly assigned to either a core training group (n=15) or a control group (n=15). The core training group performed additional core stability exercises three times per week, while the control group continued their regular training routine. All participants completed physical performance tests, including 10- and 20-meter sprint, change of direction test, countermovement jump (CMJ), and postural sway assessment using a force platform. Pre- and post-test comparisons were conducted to evaluate the intervention's effectiveness. Ethical approval was obtained from the Gazi University Ethics Committee (Approval No: 2024-1685). The study was designed to help coaches and sport scientists understand how core training may improve athletic performance parameters in amateur football players.

Eligibility Criteria:
Inclusion Criteria:

* Male amateur soccer players aged 18 to 23 years
* Actively participating in regular soccer training (minimum 3 sessions/week)
* No musculoskeletal injuries within the last 6 months
* Provided informed consent

Exclusion Criteria:

* History of lower extremity surgery
* Any neurological or vestibular disorders
* Participation in core training within the past 3 months
* Use of medication that may affect balance or neuromuscular performance
SJOV With WNJ in Microlaryngeal Surgery

The key to a successful microlaryngoscopy is adequate operative field exposure and illumination. A variety of airway control procedures has been developed to improve operative exposure. A small size endotracheal tube is commonly used. However, some surgeon may suggest a 'no-tube' technique to optimize the surgical field. This study aims to investigate effectiveness and safety of a novel technique by supraglottic jet oxygenation and ventilation (SJOV) via nasal approach to facilitate optimal visualization in laser microlaryngeal surgery for small vocal polyps resection.

The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not possible to be blinded to the assignment group, but all other staff involved in both the collection and collation of data, and administration of neurocognitive testing, are blinded to group allocation.

The primary measurement is numerical rating scale (NRS) rated by surgeon according to surgical exposure and visualization. The secondary measurements are operation duration, and Intraoperative pulse oximetry (SpO2), PetCO2.

The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for laser laryngeal surgery under general anesthesia

Exclusion Criteria:

* Patients with cardiac, pulmonary, hepatic, or renal dysfunction. Patients with nasal disease. Patients with anticipated difficult airway.
B-type Chronic Lymphocytic Leukemia (B-CLL) Subgroups: Maturation Stage and Gene Expression

B type chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the western world. It is a disease that occurs primarily in aging individuals and occurs more frequently in males than females. Although B-CLL was considered a homogeneous condition, recent studies by our laboratory and others suggest that B-CLL cases can be divided into two subgroups.

These sub-groups can be identified by either the presence or the absence of mutations in antibody genes and/or by the percentage of B-CLL cells expressing a particular protein called CD38. These two sub-groups (unmutated antibody genes high percent CD38 and mutated antibody genes low percentage CD38) follow strikingly clinically different courses. For example, the unmutated/CD38+ group experiences a much more aggressive disease and these patients almost invariably die much sooner than the cases in the other group. In addition, the patients in the mutated CD38+ group require much more chemotherapy than mutatedlCD38-. Finally, surprisingly there is a much higher representation of males in the poor outcome unmutated CD38 group than in the better outcome group. The reasons for these differences in clinical outcome and gender bias are unknown.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age,
* Patients must be able to contribute the required amount of blood without compromising their well being,
* Participants must be willing to be contacted again in the future for additional blood drawing.

Exclusion Criteria:

* Patients who are known to be anemic, with a hemoglobin \< 8,
* Patients who are known to be infected with HIV.
Craniofacial Surgery Perioperative Registry

Craniofacial reconstruction procedures are undertaken in young children to improve appearance, prevent functional disturbances, and enhance psychosocial development. These procedures involve wide scalp dissections and multiple osteotomies and have been associated with significant morbidity. The most commonly seen perioperative complications are associated with the rate and extent of blood loss. This prospective observational registry will be a research tool which will provide a means to evaluate perioperative management of these children at CHOP.

Craniofacial reconstructive surgery involves a surgical approach to the craniofacial region to repair cranial vault and facial deformities. These procedures are undertaken in young children to improve appearance, prevent functional disturbances, and enhance psychosocial development. The surgery is extensive, often requiring wide scalp dissections and multiple osteotomies and has been associated with significant morbidity. Reported complications include intra-operative cardiac arrest, massive blood loss, intraoperative tracheal extubation, venous air embolism, hypotension, coagulopathy, bradycardia, postoperative seizures, surgical site infections, facial swelling, and unplanned postoperative mechanical ventilation. The most severe and commonly seen problems are associated with the rate and extent of blood loss. Studies report estimated blood loss to average between 60% and 100% of the patient's estimated blood volume, with a range of 20-500%.(Hildebrandt et al 2007) The accurate and timely estimation of blood loss is very difficult and results in imprecise quantitative and qualitative replacement. Clinically important hypotension, metabolic acidosis, anemia, polycythemia, dilutional coagulopathy, cardiac arrest, and death are all related to blood loss. The creation of this prospective observational registry will provide a means to describe the incidence of these and other clinically important perioperative problems.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females with ages from birth to 18 years.
2. Patients undergoing surgical procedures on the craniofacial region performed by plastic surgeons, neurosurgeons, or by plastic surgeons in concert with neurosurgeons.
3. Patients undergoing plastic surgical procedures involving a craniotomy, craniectomy, maxillofacial osteotomy, strip craniectomy, or other plastic surgical procedure involving bones of the head and face.
4. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. Patients undergoing craniofacial plastic surgical procedures not involving bones of the head and face.
2. Patients not admitted to the intensive care unit following surgery.
3. Patients undergoing procedures only involving the mandible.
An Open, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration (wAMD)

This study is designed to evaluate the effect of Conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

1. Patients give fully informed consent and are willing and able to comply with all study procedures.
2. In the study eye:

   There are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.

   The criterion of active CNV should meet at least one of following three conditions :
   * fresh bleeding;
   * neurosensory detachment showed on optical coherence tomography(OCT);
   * leakage showed on fundus fluorescein angiography (FFA).
3. BCVA in study eye \< 19 letters (approximately 20/400 Snellen equivalent).

Exclusion Criteria:

1. Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision;
2. Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas;
3. History of vitreous hemorrhage within last month;
4. The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye;
5. Photodynamic therapy (PDT) or drug treatment of CNV within last 6 months in study eye, or anti-vascular endothelial growth factor (VEGF) therapy in fellow eye within last month;
6. History of glaucoma in study eye;
7. Aphakia (excluding artificial lens) in the study eye.
Nutrition Study for School Age Children

In this study, we evaluate whether dietary advice based on two healthy nutritional programs can be effectively delivered to families over one month by telephone. We hypothesize that among overweight school age children, a one-month telephone intervention will result in specific dietary changes consistent with the randomly assigned dietary intervention.

Overweight and obesity have increasingly become problems faced by children. However, the best dietary approach for managing weight in children remains unclear and how to make dietary advice practical remains a challenge. The primary aim of the study is to evaluate the feasibility of a one-month telephone-based dietary intervention for pediatric obesity in achieving changes in the target variable (dietary glycemic load or dietary fat) of the assigned intervention. We hypothesis that among overweight school age children, a one-month telephone intervention will elicit specific dietary changes consistent with the randomly assigned prescriptions. Specifically, children counseled to reduce glycemic load will achieve a significantly greater mean reduction in glycemic load than those counseled to reduced dietary fat and, conversely, those counseled to reduce dietary fat will achieve a significantly greater mean reduction in dietary fat than those counseled to reduce glycemic load. The first ten participants enrolled will comprise a pilot study group intend to inform study design/methods and will not be included in the primary analysis.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 85%ile for age and sex within the last 6 months
* Living at home with a working telephone.
* Subject conversant in English
* Parent/guardian conversant and literate in English
* Family readiness to make dietary changes

Exclusion Criteria:

* Major chronic medical illness (e.g., cancer)
* Psychiatric disorder
* Obesity-associated genetic syndrome
* Current participation in another obesity-related research study or a formal weight loss program
* Family or child following a specialized diet
* Related to or living with another child study participant
The ORCHESTRATE-Myocarditis Registry

A retrospective, observational study consisting of patients who presents with typical/atypical chest pain and have an ensuing negative ischemic evaluation

Multicenter, retrospective, observational study consisting of patients who presents with typical/atypical chest pain to the emergency department and have an ensuing negative ischemic evaluation. Planned to review the subsequent diagnostic process in these patients, including patients with CMRI (Cardiac Magnetic Resonance Imaging), PET (Positron Emission Tomography) imaging for evaluation of myocarditis with the goal of quantifying the number of patients who go on to have a proven diagnosis of myocarditis that can explain their presenting symptoms.

Eligibility Criteria:
Inclusion criteria

1. Age \>18 years
2. Patients with a presentation of typical or atypical chest pain (ICD-10 Code R07.89, R07. 9)
3. Patients with a negative ischemic workup: (including Coronary Artery Calcium Scoring/CTA, MPI, Nuclear Stress test, LHC/angiography showing anything greater than "non-obstructive CAD")

Exclusion criteria

1. Patients with any evidence of positive ischemic workup as the cause of typical/atypical chest pain (as seen on Coronary Artery Calcium Scoring/CTA, MPI, Nuclear Stress test, LHC/angiography)
2. Previously documented history of Prinzmetal angina or coronary vasospasm
3. History of prior myocardial infarction
4. History of any prior CAD with severity greater than "non-obstructive CAD" in all 3 coronary arteries
5. History of LVEF\<40%
6. Previously documented history of pericarditis
7. Previously documented history of costochondritis
Nicotine and Tobacco Message Framing Among LGBT Young Adults

This trial refines and evaluates how cultural targeting influences the effectiveness of anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among LGBT young adults. This trial seeks to determine how cultural targeting can be applied to communicate polytobacco use risk to at-risk LGBT young adults.

The goal of this study is to identify if culturally targeted (CT) or non-targeted (NT) anti-polytobacco messages are most effective for engaging LGBT consumers. Using the most effective NT messages from Aim 1, investigators will create a set of CT messages. Message framing will remain consistent between CT and NT messages; however, CT messages will include language and graphics representing LGBT values formative research and the existing peer-reviewed literature. Participants will be randomized to view CT or NT messages in a virtual lab where investigators will assess eye-tracking, self-reported perceived effectiveness, risk perceptions, and behavioral intentions. Participants will also complete a 1-week follow-up. The study aims to determine the effects of cultural targeting on attention to anti-polytobacco messages and perceived effectiveness among LGBT young adults susceptible to polytobacco use.

Eligibility Criteria:
Inclusion Criteria:

* Speaks English fluently
* Self-identifies as lesbian, gay, bisexual, transgender, queer, or another non- heterosexual orientation or non-binary gender identity
* Ever used e-cigarettes AND combustible cigarettes
* Currently uses e-cigarettes, combustible cigarettes, or both e-cigarettes and combustible cigarettes
* Resides in the United States
* Access to a laptop or desktop computer with a camera for virtual eye-tracking

Exclusion Criteria:

* Glaucoma
* Cataracts
Sedentary Behaviour and Subjective Well-being

This study will investigate the relationship between sedentary behaviour and subjective well-being among a sample of university students. Eligible participants will fill out an online survey with questions assessing their sedentary behaviour, physical activity, subjective well-being, life satisfaction, depression, anxiety, and demographic variables.

An electronic survey will be used to assess outcomes of interest (i.e., demographics, sedentary behaviour and physical activity history, subjective well-being, life satisfaction, depression, and anxiety). The survey will be created and hosted on SoSci Survey. Interested participants will contact the investigators and will be sent a personal link to access the survey. Upon following the link, participants will answer inclusion/exclusion criteria and give electronic consent. Upon confirming consent and eligibility, participants will complete the survey. Upon completion of the survey, participants will be thanked and offered an entry into a draw.

Eligibility Criteria:
Inclusion Criteria:

* Currently a full-time student enrolled at Western University
* Are 18 years of age or older
* Are able to read and write in English
* Have access to a computer with internet

Exclusion Criteria:

* Part-time enrollment or currently on a leave of absence from full-time studies at Western University